A few years back, several New Zealand scientists began tinkering with petunias, the elegant flowers blooming in many gardens. Playing with pigment genes, they developed biotech varieties with lush dark leaves, their funnel-shaped flowers popping against a midnight backdrop.
The Kiwis wondered if they could sell their flowers. They wrote to regulators in the United States, the country most open to genetic engineering. The Agriculture Department responded, saying the petunias, because of the technology used, did not require its oversight -- a promising decision.
Before the biologists went further, however, the work fell to a reorganization. Everyone moved on.
They had no idea they'd blown open a huge loophole in U.S. biotech regulations.
"It wasn't really considered an enormous deal," said Roger Bourne, the communications director for the New Zealand Institute for Plant & Food Research, which developed the petunias. (The institute declined to identify the scientists involved.) In 2007, the biologists, Bourne said, innocently wondered what "the commercial situation would be with this? And asked the question."
Despite its low profile, USDA's petunia decision is set to revolutionize the way genetically modified crops from trees to fruit are regulated in the United States. The precedent has created a credible route for developers to get their products to market with less oversight and at a far more rapid, and cheaper, pace.
The petunia pathway does not end government oversight of all biotech plants or animals, especially those intended for human consumption, but it shakes the foundation of the long-standing framework used to oversee these products. It may allow new products to skirt extensive environmental review. Avoid a certain set of genetic resources, the agency seems to be telling startups, and biotech plants can be developed without interference, let alone field trials.
The precedent's vast potential became clear earlier this month, when USDA announced that it wouldn't consider a biotech lawn grass developed by Scotts Miracle-Gro Co. under its control (Greenwire, July 6). That decision, likely to face legal challenges, frees the company to develop a variety of modified lawn grasses that can be sold to consumers whenever Scotts deems the products ready.
"There's nothing really sinister about it," said Rich Shank, Scott's head of regulatory affairs.
The company first developed its grasses, engineered to resist the common weedkiller Roundup, using approaches that are regulated by USDA. One such plant, a creeping bentgrass of the type widely used for golf courses, has proved nearly impossible to eradicate from its past field trial site. It has been under review for nearly a decade and is still several years away from a final decision.
That was no way of doing business, Shank said, so Scotts began exploring other options.
"We [began] looking at the process of going with the nonregulated approach," he said.
Last year, someone at Scotts -- Shank said he is uncertain who -- got wind that the USDA had approved the Kiwi petunias. Many of the company's newer biotech grasses followed the same developmental pattern as the flowers. It was an intriguing precedent, and when Scotts wrote USDA last fall asking if its bluegrass would be regulated, it cited the agency's petunia letter as its supporting evidence.
Given the ratification provided by Scotts, anyone working in plant biotech -- say, a scientist developing tree seedlings resistant to ash borer -- would be foolish to not follow the de facto guidelines USDA has now established, said Drew Kershen, an agricultural law professor at the University of Oklahoma who has in the past consulted for the biotech industry.
"If I were a developer in any other company, I'd say, 'Oh my goodness. I can do this,'" he said.
Nearly any small or large biotech developer should be able to adhere to these standards, which could spur independent scientists to return to the field, said Roger Beachy, the former head of USDA's National Institute of Food and Agriculture and one of plant biotechology's early pioneers, developing techniques to induce virus resistance in vegetables.
"Academics have been using what tools they can to get things done," Beachy said. "Maybe this can encourage academics to move forward. We've had very little participation from [them]."
For years, companies and academic scientists have complained about a general chill in the process of approving bioengineered crops. Federal courts have forced USDA to conduct thorough environmental reviews of several Roundup-resistant crops, such as alfalfa and sugar beet, that it had previously decided to deregulate. According to some estimates, it can take $20 million to get a single biotech crop approved in the United States.
These reversals have come with good reason, spurred by fears that biotech crops could pollinate with their conventional varieties, compromising exports to regions wary of genetic engineering. The courts have also expressed concern at how the spreading of Roundup resistance to an increasing number of plants could cause more and more weeds to develop immunity to the herbicide.
Longtime biotech opponents are outraged by USDA's decision to exclude certain categories of biotech crops from its oversight. It is a "blatant end-run around regulatory oversight," said George Kimbrell, a senior attorney at the Center for Food Safety, which has scored a spate of legal victories against biotech companies, including Scotts, in the past few years.
"This illustrates that the agency is concerned only with getting these crops to market as quickly as possible, and not doing its job in regulating potential harmful impacts," Kimbrell said. "It's a microcosm of a larger regulatory failing."
But the picture painted by the Center for Food Safety may be too simple.
Many scientists and companies have long been frustrated by how the government chose to regulate biotechnology, a system established three decades ago when the technology seemed startlingly new, threatening and confusing. In a way, USDA's petunia pathway puts the government back on the road toward a more scientifically sound approach, they say.
During the 1980s, the government suffered from a split personality when it came to biotech rules.
The nascent biotech industry said its products were revolutionary but also presented no risks different from traditional varieties. The government accepted arguments that no new laws were needed to regulate biotech creations, instead adapting existing rules to modified plants, animals and microbes, a system called the Coordinated Framework for its shared responsibility between USDA, U.S. EPA and the Food and Drug Administration.
This adaptation of laws meant to control weedkillers, plant pests and animal drugs to plant and animal biotechnology resulted in some strange twists of language and definition, said Alison Peck, a law professor at West Virginia University.
"The Coordinated Framework always involved a strange doublespeak," Peck said.
Since it had no new laws to empower it, USDA "captured" all the biotech plants made in the United States under its authority over potential pests from the Plant Protection Act. In its early days, all biotech products involved either tools or DNA stemming from pests like bacteria and viruses, and so all plants fell under the department's sway.
Since then, technology has shifted rapidly, in ways not anticipated by 1980s regulators. Scientists now understand the function of a wide variety of plant genes, not just microbial genes, and they can insert this DNA with tools like the gene gun, which shoots DNA into a plant with high-velocity metals. Scientists are also optimizing custom proteins that can cause targeted DNA mutations without introducing foreign genes, further confusing what exactly "genetically modified" will mean over the next five years (Greenwire, Nov. 16, 2010).
Given these advances, the New Zealand developers and Scotts, among others, could develop their plants without any technologies that could be considered plant pests, prompting USDA's ruling that they fell outside its legal control.
It was an almost inevitable loophole, given the government's early decisions, Peck said.
"The result of trying to treat biotech products just like any other plant pest or potential plant pest is precisely the kind of unintended consequences we see in the Kentucky bluegrass case," Peck said. "No conscious decision was ever made by anyone to exempt this technology from oversight. ... Now we have a technology that, by default, is unregulated."
Some argue that rather than exploiting a loophole, the petunia pathway restores biotech regulations to the science-based standards recommended by the nation's premier scientific body, the National Academy of Sciences. In the late 1980s, the academy advised the government to regulate novel plants and animals based on the risk they could pose to human safety or the environment, rather than technology used to create them -- a path regulators and Congress chose not follow.
There is no inherent risk in biotechnology, a reality that the government never adopted, Beachy said. Since leaving government service, Beachy has returned several times to Washington, testifying in Congress on how biotech fears have been based on "potential risks, not real risks," he said.
USDA's petunia decision shows how awkward its regulations have become. There is no scientific reason a biotech crop created with bacteria-based tools is different from one made with a gene gun, Oklahoma's Kershen said. It is a technicality, a legal distinction, not a risk-based assessment.
"It really shows in a deeper way the scientific unsoundness of the regulations," he said.
Risk evaluations at issue
Of course, risk-based regulations depend on agencies properly evaluating risk.
USDA had a duty to evaluate whether Scotts' bluegrass could behave as a noxious weed, potentially damaging the country's agriculture, natural resources or environment. In its decision not to control the grass, the agency stressed that the bluegrass would not damage farming, giving short shrift to the environmental issues. If EPA had looked at the grass, it could have had a very different evaluation, said Bryan Endres, a law professor at the University of Illinois.
"This decision really clarifies where the [USDA] secretary stands on this," Endres said.
Many details can emerge from an extensive environmental review of a biotech grass. For example, a draft opinion developed by the Fish and Wildlife Service after reviewing Scotts' bentgrass, obtained by the Center for Food Safety, found that widespread use of the grass could jeopardize the continued existence of the Willamette daisy, an endangered species found only in Oregon.
Could similar problems emerge with the bluegrass? There is no clear answer, scientists say.
From an environmental standpoint, there is little difference between the Roundup-resistant bentgrass or Scotts' proposed bluegrass, said Carol Mallory-Smith, head of Oregon State University's weed science program, who tracked the bentgrass as it escaped from its trial site (Greenwire, Oct. 7).
Mallory-Smith does not consider bluegrass to be any more a weed than the USDA does. Conventional varieties of the grass are an important crop in the Pacific Northwest. But still, she found USDA's risk analysis lacking in many details, with little data provided for why it said that the bluegrass would be less damaging than what might be estimated through a traditional weed risk assessment.
"I consider it a very convenient ruling based on the trouble that they've had," she said.
For example, since Roundup could no longer be used to stop the grass, other controls will have to be employed. The agency did a poor job of identifying these strategies, and one plan it did cite -- controlled burns -- is actively discouraged by states producing bluegrass seed, Mallory-Smith said.
"It means they're out of touch with the reality going on here," she said.
Widespread use of Roundup-resistant grass could also enable the spread of herbicide-tolerant weeds. Already many of the country's corn and soy crops are bioengineered to resist Roundup, one of the most environmentally benign herbicides. Add grass into this mix and the selective pressure grows, causing fears that Roundup and its generic equivalent, glyphosate, could become widely ineffective.
In many ways, these are problems that go beyond biotechnology, but not beyond agriculture. It seems like the USDA division in charge of biotech crops, the Animal and Plant Health Inspection Service, is saying this is not their problem, Mallory-Smith said. And that may be true.
"But certainly the agency has a responsibility to agriculture [to address these issues]," she said.
Scott's sales plan
Despite the regulatory fuss, Scotts is unlikely to sell bluegrass solely resistant to Roundup.
The company's letter was a test of its legal strategy, Shank said. Rather, Scotts plans to build a "dwarfing" trait into its bluegrass, which allows the grass to be cut once or twice a year -- a luring pitch in the summer swelter. Since slow-growing grass cannot compete with typical varieties, the dwarf bluegrass will need weedkiller resistance to survive.
"Ultimately, it will be a very environmentally friendly variety of grass," he said.
Over the next two years, Scotts plans to run small-scale studies of its resistant grass at its primary research site, using protocols similar to those typically mandated by USDA trials. Though the grass is not regulated, the company wants to prevent its pollen from spreading, he said.
The need to restrict pollen spread is very much on companies' minds, the University of Illinois' Endres said. Earlier this month, the German firm Bayer AG agreed to pay U.S. rice farmers $750 million after a biotech rice the company developed escaped into commercial supplies, causing a brief panic and price drop (Greenwire, July 5).
While Scotts' grass will not be regulated -- an important distinction -- the Bayer case still demonstrates that civil juries are open to harshly punishing companies if they deem them negligent of coexisting with organic and conventional varieties, Endres added.
Perhaps the scientists most likely to jump on the petunia pathway are those developing biotech prairie grasses, like switchgrass or Miscanthus, to be used as energy crops for next-generation biofuels. USDA had previously indicated that these grasses, which can survive in the wild and grow for many years, would face stricter regulations. Now, given that these crops are inedible, it is possible the grasses would not require USDA or FDA review.
As for the dark-leaf petunias, the New Zealand scientists have not changed their plans to put the flowers aside. They never planned to undermine the U.S. regulatory system; they used alternative biotech tools because it was open source, Bourne said. Anyway, the institute has other priorities.
"This is now considered nonstrategic area," he said.