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GMO TESTING Social and economic factors shape new regulations that in turn drive the technology. Laura Ruth
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wo new rulings about genetically modified organisms (GMOs) are the latest evidence of the increasing pressure to address continuing concerns about the health effects, environmental impacts, and international trade of these controversial products. On July 2, 2003, the European Union (EU) approved more stringent regulations for labeling GMOs in crops, food, and feed products. The day before, the Codex Alimentarius Commission (Codex) from the Food and Agriculture Organization and the World Health Organization planned to recommend a case-by-case premarket health risk assessment of a GM product, including the accuracy of any labeling. “The Codex ruling would cover the suit the U.S. filed against the EU through the World Trade Organization [WTO] in May 2003,” says Philip Bereano, professor of technology and public policy at the University of Washington. The suit claims that the five-year-old EU moratorium on approving any new GMOs for sale in member countries is based on unfair trade rather than safety concerns.
A balancing act Concerns about the impact on health and the environment continue because studies show both beneficial and harmful effects. A 2002 study by the National Center for Food and Agriculture Policy, a private nonprofit organization, concludes that herbicide-tolerant soybeans helped farmers reduce annual costs by $15 an acre. The North American Council for Biotechnology Information (CBI), a trade association, has compiled statistics showing that no-till conservation practices—which lead to less erosion—have increased 35% since the introduction of biotech crops in 1996. A recently published study reports positive results from Bt cotton field trials in India (Science, 2003, 299, 900–902). And a recent Danish National Environmental Research Institute study indicates there was a doubling of weed biomass, which is considered environmentally friendly, in fields of engineered sugarbeet compared with conventional beets. S E P T E M B E R 1 , 2 0 0 3 / A N A LY T I C A L C H E M I S T R Y
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GM plots also contained more food for birds: insects, spiders, of the Codex policy is the Cartagena Protocol on Biosafety (CPB), which will regulate the international transport of living and other arthropods. However, the same Danish study indicates that the additional modified organisms by requiring exporters to obtain consent weed species may upset the biodiversity. Furthermore, Suman from importers before shipping. Bereano reports that 48 counSahai from Gene Campaign, a private nonprofit group in India, tries have adopted the CPB since May 2000. “It is likely the strongly disagrees that Bt cotton is having a positive impact in CPB will come into effect this fall, 90 days after the 50th counIndia. She recently told the Council for Responsible Genetics try has adopted the protocol,” he adds. The heart of the Codex and CPB policies is the precaution(CRG), an independent nonprofit group in the United States, that ary principle and traceability, exBt cotton in India had low crop yields as plains Bereano. The precautionary well as poor germination and pest resistprinciple is based on a “look before ance. The Indian Bt cotton did not do you leap” philosophy. The princiwell because the varieties were not of ple argues that preventative meagood quality and gene expression may sures should be taken even though not have coincided with the pest attack. the scientific evidence of harm is “Use of Bt cotton is a failure in India,” not clear, he says. This principle is says CRG’s Sujatha Byravan. Sahai adds, used in more than 40 domestic laws “[Overall], GM crops must be . . . and German environmental law, and specifically adapted to the agro-climatthe EU has adopted it for conic region where they are to be grown.” sumers. However, the United States Don Kendall from the U.S. Departhas moved to a risk-based approach, ment of Agriculture Grain Inspection which evaluates the “danger” of a Packers and Stockyards Administration product based on clear scientific ev(GIPSA) explains that crops are being idence, and argues that the precaudeveloped to tolerate a variety of envitionary principle hinders scienceronmental conditions, such as highbased regulations. salinity soils, drought, insect infestation, Traceability dictates that records and particular fungi. A Japanese GMO-free label (yellow box). It be kept during the processing of In the consumer health area, Byravan reads, “This product is made of soybeans GMO in a product. U.S. products claims the ill effects—allergic responses, that are not genetically modified organisms.” already have composition-based latoxicity, and increased antibiotic resistbeling, such as “kosher” and “not ance—are well documented. On the other hand, CBI cites work done by the European Commission made from concentrate”, notes Bereano, but GMO products are (EC) and the United States to prove that biotech crops and food not labeled. Representatives from France, Austria, Denmark, are safe. A 15-year, $64 million EC study with 400 research teams Greece, Luxembourg, and Italy have said that they will continue on 81 projects confirmed the safety of biotechnology crops. In blocking approvals of new GM crops until there is traceability. October 2001, the U.S. Environmental Protection Agency declared Bt cotton and corn safe for health and the environment. GMO thresholds and labeling Consumer attitudes toward the use of GMOs are as mixed Meanwhile, the EU threshold for considering a product GMOas the scientific evidence. In April 2003, the U.K. Food Stan- free will decrease from 1.0 to 0.9% GM material. This will also dards Agency published results from a citizen’s jury that found be the new threshold for approved GMOs in feed; nonapproved 60% of those queried think GM foods should be available for GMOs will be held to 0.5%. Byravan thinks the increased strinpurchase in the United Kingdom. However, the 2001 EU gency will make DNA GMO testing more difficult—and per“Eurobarometer” consumer studies reported that 56.5% think haps too expensive—which might force industry to abandon GMOs are dangerous; 94.6% want the right to choose whether GMOs. Members of industry agree that the new thresholds will to have GMOs in their food; 85.9% want to know more about make such testing a mess. GMOs in food; and 85.8% only want GMOs that have been Eight countries, in addition to the EU, have instituted GMO proven scientifically harmless in food. According to Bereano, a threshold standards. Taiwan and Japan have set thresholds of 5% survey by Novartis indicates that 93% of Americans want ge- GMO; South Korea, 3%; and Australia, the Czech Republic, netically engineered food labeled. Craig Winters from The Hungary, New Zealand, and Poland, 1%. As more countries and Campaign, a nonprofit organization, reports that a July 2003 parts of countries, such as the states of Vermont and Maine, Roy Morgan International survey reveals that 46% of Ameri- consider and adopt labeling regulations, Bereano says a universal cans and 55% of Australians and Britons try to avoid GM foods. standard is being debated. “The industry, of course, wants counAll of these studies are leading to protective international poli- tries to move to the higher numbers, [while] many enviro groups cies that will drive new analyses. The environmental counterpart push for the lower ones,” he explains. 394 A
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The criteria for setting the thresholds In the lab vary and are still being debated. “There With so many GMO regulations, setting is no scientific justification for the labellaboratory standards is the main problem, ing threshold,” according to Guy Van den says Yves Bertheau from the National InEede of the EC–Directorate General Joint stitute of Agricultural Research–Versailles Research Centre (JRC). “It is not related (France). Van den Eede adds, “All these to safety or health issues as these prodissues require a strong and harmonized ucts are assumed to be safe.” But Bereano analytical component.” The EU and sevnotes that consumer and environmental eral individual countries are creating their groups remain unconvinced and continown laboratory quality controls. France ue pressing for more research. released a standard in December 2000 In the EU, establishing a threshold after a 1998 national survey showed discame from empirically balancing interests. crepancies in GMO detection results, inAccording to Van den Eede, the 1% limit, cluding a lack of negative controls and which came from the EC, was a balance use of non-robust tests, Bertheau says. between consumer requests (the lower, The French standard provides guidelines the better), company requests (the highand general requirements for detection er, the better), and technical capabilities method performance, laboratory organi(the lower, the larger the error). Though zation, good laboratory practices, qualithe European Association for Bioindusty controls, and results. Working groups tries (EuropaBio) supports the 1% and of both the European Committee for 0.9% thresholds, it initially favored a Standardization and the International higher value, like Japan’s, which is more Organization for Standardization (ISO) in line with other current commodity have used the French standard as a basis thresholds, says the association’s Adeline while developing international ones. Brazil, Farrelly. For example, there is a tolerance Canada, and South Africa also used the of up to 5% of nonorganic material in orFrench standard as a start for their own ganic crops. Farrelly notes, “The 0.9% is a regulations. political difference, and it’s silly to be playHori reports that Japan proposed ading around at that level.” EuropaBio is not ditional ISO methods at the Fourth ISO A can of Leve Sol Oil, a refined soy oil in favor of traceability because they expect GMO Meeting in Buenos Aires in June used in Brazil, with a Cert ID label verit to add a lot of bureaucracy and expense. 2003. He expects the Japanese stanifying that the product is GMO-free. But retailers hope that traceability will ease dard—quantitation of the construct-speconsumer concerns. cific region of a GMO using real-time The Iowa-based company Genetic ID seems to have predicted PCR with a plasmid as a reference molecule—along with four what retailers want and has been providing a traceability pro- others, to become international standards within three years. gram, Cert ID, since 1999. John Fagan of Genetic ID explains Mike Russell of GeneScan praises Japan’s unique approach of dethat a product receives a Cert ID label if it contains
