The Supreme Court on Tuesday heard its first case involving genetically modified crops and their potential environmental and health impacts — 14 years after the first biotech crop came to market.
Justices sharply questioned a lower court's decision that has prohibited biotech giant Monsanto Co. from selling genetically engineered alfalfa seeds, possibly paving the way for the company to distribute the seeds for the first time since 2007.
The case has been closely watched by environmentalists and agribusiness. A federal judge in San Francisco barred the planting of genetically engineered alfalfa nationwide until the government could adequately study the crop's potential impact on organic and conventional varieties.
Monsanto is arguing that the ban was too broad and was based on the assumption that their products were harmful. Opponents of the use of genetically engineered seeds say they can contaminate conventional crops, but Monsanto says such cross-pollination is unlikely.
Organic groups and farmers exporting to Europe, where genetically modified crops are unpopular, have staunchly opposed the development of such seeds.
Environmentalists are concerned with the case's effect on a federal law that requires the government to review a product's effect on the environment before approving it. The U.S. Department of Agriculture earlier approved the seeds, but courts in the western states of California and Oregon said USDA did not look hard enough at whether the seeds would eventually share their genes with other crops.
Aside from the precedent, the case may be irrelevant in another year, when the USDA is expected to finish the full environmental review that was not done in the first place. It is expected to again approve the seeds for production.
Several justices appeared skeptical that the lower court had the authority to fully ban the sale of the product because of the pending environmental review. Chief Justice John Roberts questioned why the court issued the injunction instead of simply remanding the matter back to the USDA.
Justice Antonin Scalia appeared even more wary, questioning the idea that genetically modified crops could contaminate other crops.
"This isn't the contamination of the New York City water supply," he said. "This isn't the end of the world, it really isn't."
Alfalfa, which is used for livestock feed and can be planted in spring or fall, is a major crop grown on about 22 million acres in the U.S., Monsanto said in court papers. Monsanto's alfalfa is made from genetic material from bacteria that makes the crop resistant to the popular weed killer Roundup.
Justice Stephen Breyer did not taking part in the case because his brother, U.S. District Judge Charles Breyer in San Francisco, issued the initial ruling against Monsanto.
A decision is expected before late June.
Concerns range from worries about how nontraditional genetic traits in crops could affect human and animal health to the spread of herbicide-resistant weeds.
Robert Kremer, a U.S. government microbiologist at the University of Missouri, has spent two decades analyzing the rich dirt that yields billions of bushels of food each year and helps the United States retain its title as breadbasket of the world.
Recent findings by Kremer and other agricultural scientists are raising fresh concerns about Monsanto's products and the Washington agencies that oversee them. The same seeds and chemicals spread across millions of acres of U.S. farmland could be creating unforeseen problems in the plants and soil, this body of research shows.
'Might be setting up a huge problem'
Kremer, who works for the U.S. Department of Agriculture's Agricultural Research Service (ARS), is among a group of scientists who are turning up potential problems with glyphosate, the key ingredient in Monsanto's Roundup and the most widely used weed-killer in the world.
"This could be something quite big. We might be setting up a huge problem," said Kremer, who expressed alarm that regulators were not paying enough attention to the potential risks from biotechnology on the farm, including his own research.
"This is supposed to be a wonderful tool for the farmer ... but in many situations it may actually be a detriment," Kremer said. "We have glyphosate released into the soil which appears to be affecting root growth and root-associated microbes. We need to understand what is the long-term trend here," he said.
Outside researchers have also raised concerns over the years that glyphosate use may be linked to cancer, miscarriages and other health problems in people.
Monsanto says extensive research shows glyphosate is safe for humans and the environment, and has an entire section on its website devoted to refuting the reports. Monsanto says extensive investigation of questions about changes in soil micro-organisms has found no long-term ill effects.
Peering into his petri dishes, Kremer isn't so sure.
"Science is not being considered in policy setting and deregulation," said Kremer. "This research is important. We need to be vigilant."
Whatever the point of view on the crops themselves, there are many people on both sides of the debate who say that the current U.S. regulatory apparatus is ill-equipped to adequately address the concerns. Indeed, many experts say the U.S. government does more to promote global acceptance of biotech crops than to protect the public from possible harmful consequences.
"We don't have a robust enough regulatory system to be able to give us a definitive answer about whether these crops are safe or not. We simply aren't doing the kinds of tests we need to do to have confidence in the safety of these crops," said Doug Gurian-Sherman, a scientist who served on a FDA biotech advisory subcommittee from 2002 to 2005.
"The U.S. response (to questions about biotech crop safety) has been an extremely patronizing one. They say 'We know best, trust us,'" added Gurian-Sherman, now a senior scientist at the Union of Concerned Scientists, a nonprofit environmental group.
The World Health Organization has not taken a stand on biotech crops generally, simply stating "individual GM foods and their safety should be assessed on a case-by-case basis."
And while many scientists around the world cite research they say shows health and environmental risks tied to GMOs, many other scientists say research proves the crops are no different than conventional types.
With a growing world population and a need to increase food production in poor nations, confidence in the regulatory system in the leading biotech crop country is considered critical.
"One of the things that we think is important to do is to have regular reviews and updates of our strategies for regulating products of biotechnology," said Roger Beachy, a biotech crop supporter who was appointed last year as director of the National Institute of Food and Agriculture.
"We want to look carefully to see that they are logical and science-based but still maintain the confidence of the consumer to ensure that the projects that are developed and released have the highest level of oversight," added Beachy.
So far, that confidence has been lacking. Courts have cited regulators for failing to do their jobs properly and advisers and auditors have sought sweeping changes.
Even Wall Street has taken note. In January, shares in Monsanto fell more than 3 percent amid a rush of hedging activity during a morning trading session after a report by European scientists in the International Journal of Biological Sciences found signs of toxicity in the livers and kidneys of rats fed the company's biotech corn.
Monsanto has said the European study had "unsubstantiated conclusions," and says it is confident its products are well tested and safe.
Indeed, farmers around the world seem to be embracing biotech crops that have been altered to resist bugs and tolerate weed-killing treatments while yielding more. According to an industry report issued in February, 14 million farmers in 25 countries planted biotech crops on 330 million acres in 2009, with the United States alone accounting for 158 million acres.
No U.S. government testing
A common complaint is that the U.S. government conducts no independent testing of these biotech crops before they are approved, and does little to track their consequences after.
The developers of these crop technologies, including Monsanto and its chief rival DuPont, tightly curtail independent scientists from conducting their own studies. Because the companies patent their genetic alterations, outsiders are barred from testing the biotech seeds without company approvals.
Unlike several other countries, including France, Japan and Germany, the United States has never passed a law for regulating genetically modified crop technologies. Rather, the government has tried to incorporate regulation into laws already in existence before biotech crops were developed.
The result is a system that treats a genetically modified fish as a drug subject to Federal Drug Administration oversight, and a herbicide-tolerant corn seed as a potential "pest" that needs to be regulated by USDA's Animal Plant Health Inspection Service before its sale to farmers.
The process is also costly and time-consuming for biotech crop developers, which might need to go through three different regulators before commercializing a new product.
Nina Fedoroff, a special adviser on science and technology to the U.S. State Department, which promotes GMO adoption overseas, said even though she is confident that biotech crops are ultimately safe and highly beneficial for agriculture and food production, an improved regulatory framework could help boost confidence in the products.
"We preach to the world about science-based regulations but really our regulations on crop biotechnology are not yet science-based," said Fedoroff. "They are way, way out of date. In many countries scientists are much better represented at the government ranks than they are here."
Agriculture Secretary Tom Vilsack, a former governor of top U.S. corn producing state Iowa, also said he recognizes change is needed. The USDA is in fact developing new rules for regulating genetically modified crops but the process has dragged out now for more than six years amid heavy lobbying from corporate interests and consumer and environmental groups.
"There is no question that our rules and regulations have to be modernized," Vilsack told Reuters. "The more information you find out, the more you have to look at your regulations to make sure they are doing what they have to do. There are some issues we are still grappling with."
The USDA, EPA and FDA say they work hard to ensure that crops produced through genetic engineering for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.
But a November 2008 report by the Government Accountability Office, the investigative arm of the U.S. Congress, cited several problems. Among the shortcomings mentioned in the report is a lack of a coordinated program to determine whether the "spread of genetic traits is causing undesirable effects on the environment, non-GE segments of agriculture, or food safety."
The GAO took the FDA to task for not requiring companies like Monsanto and other GMO developers to notify the agency before selling new products, relying on only voluntary notice. It recommended the FDA publicize the results of food safety assessments of genetically engineered crops and advised the three agencies to develop a risk-based strategy to monitor use of GE crops.
But more than a year later, most of the recommendations remain unimplemented, according to Lisa Shames, director of the natural resources and environment arm of the GAO.
"We can only influence agencies to take action. We can't compel them to," she said.
Since 1987, the USDA has overseen genetically modified organisms through the Animal and Plant Health Inspection Service. APHIS's Biotechnology Regulatory Services regulates GE organisms based on "plant pest risk."
Monsanto and other biocrop developers must petition APHIS to grant their genetically altered organisms "nonregulated status" — that is, permission to grow these plants without official oversight. To win approval, the companies must demonstrate that their tests show the new varieties do not pose a risk to plant health.
"APHIS grants nonregulated status only when it determines that the new genetically engineered variety is unlikely to pose a plant pest risk," said USDA spokesman Michael Pina, who labeled the current regulatory system "strong."