“Do we want those things to go out unregulated?” asked Alan McHughen of the University of California, Riverside, who has worked to develop both biotech...

The result is that the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), which gives authorization to test crops in the field or move them across state lines for sale, has in recent years found itself unable to regulate an increasing number of GE crops. This year alone, eight GE plants —everything from glowing Arabidopsis to denser loblolly pine to higher-yield maize—fell outside the purview of APHIS’s authority.

OKANAGAN SPECIALTY FRUITSThirty years ago, scientists could have only dreamed about techniques to manipulate the genome that researchers have at their disposal these days. It should come as no surprise, then, that regulations governing genetically engineered (GE) crops—devised during the Reagan administration—don’t reflect these newer methods.

Criticism of how GMOs make it onto the market comes from both sides—those who say regulations are too permissive and those who say they are burdensome for biotech crop developers, especially academic groups and smaller firms. McHughen said there has been little effort in the last 30 years to change biotech crop regulations. But new generations of genetic engineering techniques have prompted the government to reconsider. This summer, the White House issued a memorandum for the USDA, the Food and Drug Administration, and the Environmental Protection Agency—all of which have some control over genetically modified organisms (GMOs)—to update their rules and “develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology.”

The USDA recognizes the limitations of its current practices. “The thing with our existing trigger, [which initiates regulation, is that] it might have made sense back in 1987, but it doesn’t make a lot of sense now,” said Mike Firko, APHIS’s deputy administrator of biotechnology regulatory services. Firko told The Scientist that APHIS plans to have a proposed new rule for biotech regulation published by next summer. “There are a lot of techniques out there that might create a plant pest or weed risk, so we want to make sure our regulations are current.”

The existing rule

For now, it is the technique that matters when it comes to APHIS oversight. The “trigger” for regulation Firko mentioned is a provision of the Plant Protection Act that is intended to prevent the release of plant pests—insects, pathogens, and other organisms that harm plants—and weeds. In the mid-’80s, when the regulations for biotech crops were established, methods to genetically engineer plants almost always included DNA from the plant pest Agrobacterium tumefasciens. So any introduction of Agrobacterium would automatically spark regulation. It was a de facto way to oversee interstate commerce and importation of biotech crops.

Companies that use Agrobacterium or any other plant pest can apply for deregulation. Firko said this happens about five times a year. For instance, Okanagan Specialty Fruits achieved deregulated status for its nonbrowning “Arctic” apple—which uses a promoter from cauliflower mosaic virus delivered by Agrobacterium to silence the browning enzyme—in February after a decade-long process. Field trials were first planted in 2003 and 2005. In 2010, the company submitted documents about the apples and requested deregulation. Five years later, after review by the USDA and public comment periods, the agency announced its decision.

“We certainly did not expect the process to take nearly so long, especially since Arctic apple fruit contains no novel proteins and in many ways involves a much more innocuous genetic change than many other approved biotech crops,” Okanagan President Neal Carter wrote in an email to The Scientist. “For a small, grower-led company like ours (our team had less than five full time employees when we submitted the USDA petition), it was a monumental challenge to go through such a lengthy, costly process to achieve deregulation.”

The nonbrowning apples from Okanagan are the first of their kind. But there are numerous instances of other crops with the same traits, such as those engineered to contain proteins from the bacterium Bacillus thuringiensis for resistance to pests and herbicides. But even if one crop has been deregulated, companies must go through the same assessment for each new one because they all trigger regulation under the Plant Protection Act.

Some say this creates additional burdens for products and techniques APHIS has declared safe over and again. Ty Vaughn, the director of global regulatory affairs at Monsanto, said he is hopeful there will be some reform that takes into account past experiences with similar crops. “Can it become less burdensome so companies large and small have some predictability?” he asked. “No one is advocating for less scientific rigor. Just bridging what’s already done to assess the novel part of the product.”

Firko said the idea of incorporating data from other, yet similar GE crops for regulatory decisions is under consideration as the agency develops its proposed new rule, but he couldn’t yet comment on how genetic engineering techniques—old and new—would be handled. “We certainly don’t want to stigmatize techniques,” he says.

Yet while crops based on the same genetic changes are subject to scrutiny by APHIS, others completely new to the world of biotech agriculture fly under the radar.

The loophole

Recombinant DNA methods that don’t rely on a plant pest or don’t include a plant pest’s DNA in the final product get a very different treatment. In these cases, developers can petition APHIS for clarification about their regulation status. For example, in 2014, a research team from Iowa State asked whether its disease-resistant rice, produced via TALENs, would be regulated. Although Agrobacterium aided the transformation, “the final rice plants do not contain any inserted genetic material and APHIS has no reason to believe that the plants of these rice lines are plant pests,” the agency wrote in response this year. “Therefore, consistent with previous responses to similar letters of inquiry, APHIS does not consider the five rice lines . . . to be regulated under 7 CFR part 340.”

“The way that these decisions are being made does not seem to have a basis in the level of risk or level of concern,” said Jennifer Kuzma, a science and technology policy expert at North Carolina State University. “We need better clarity,” she added. “It’s not only confusing to the public who wants to understand this, but also to developers of the products.” Kuzma’s other complaint is the lack of transparency. The public and other interested groups—aside from APHIS and the developer—are not given an opportunity to comment on the decisions.

These “not regulated” determinations have been increasing in recent years. According to a 2014 analysis, 26 inquiries asking whether a product is regulated have been submitted to APHIS in the past couple of decades. Just six were submitted before 2010. And among those 26, four products were regulated.

Given the expense and the years of work and waiting to receive deregulated status of regulated plants, there’s a big incentive to adopt alternative technologies to avoid regulation in the first place. Kuzma said she has attended meetings where people have discussed promoting genetic engineering tools so developers can escape capture by APHIS’s oversight. “Regulation has been promoting innovation,” she told The Scientist.

To McHughen’s mind, a more appropriate way to go about regulating biotech crops—to avoid over-regulating products and methods considered safe by APHIS while closing loopholes for novel techniques—is to focus less on the process and more on the product. Canada has taken such an approach. Any plant with a new trait must undergo assessment by the Canadian Food Inspection Agency. “We do not limit ourselves to any method of trait introduction,” including conventional breeding, explained Martine de Graaff, the acting national manager for the agency’s Plant Biosafety Office.

Firko said the Canadian system represents one end of the regulatory spectrum, while a completely voluntary system might represent the other, most permissive end. APHIS is still discussing with stakeholders where the proposed rule will fall along that spectrum, he added.