WASHINGTON, Feb. 10, 2016 - The Agriculture Department has formally launched what would be the most far-reaching overhaul of its biotechnology regulations since they were first developed decades ago.

The idea is to accelerate the development of new crop traits that USDA believes pose little risk to the environment, with the side benefit of making it easier for public researchers and small companies to get their ideas to market. The new system USDA envisions would end or at least curtail what scientists consider unnecessary, redundant reviews of essentially the same traits.

However, USDA’s outline of the plan in a 14-page document released last week for public comment is raising some concerns and questions in the industry.

The document proposes a sweeping definition of “biotechnology” that includes not just the traditional transgenic crops commonly known as GMOs but also new techniques such as genome editing, which don’t require inserting genes from other species into a plant. Genome editing allows researchers to switch genes off in a plant or to introduce traits from a wild relative of the plant, essentially doing in a faster, more precise manner what plant breeders have been doing for generations.

The USDA document, which is formally known as a “notice of intent to prepare an environmental impact statement,” goes on to lay out in broad terms a new two-step process for analyzing new crop traits and deciding which ones would be subject to regulation.

(The plan is labeled the “second alternative” in the document. There are three other, essentially throw-away alternatives outlined -- one is to leave the current system unchanged, another is to replace it with a much more stringent system, and the third is to essentially deregulate biotechnology.)

Almost no one argues that the current system should be left alone, even groups such as the Center for Food Safety that argue federal regulation of biotechnology is much too weak.

The fear among some is that defining gene editing as “biotechnology” will mean the public will see the products as GMOs or genetically engineered.

USDA’s current regulations focus almost exclusively on “transgenic” species, plants that have been altered through the introduction of genes from other species, such as a bacterium.

Despite the broad definition, USDA is proposing to exempt some gene editing techniques from the regulatory process, but industry officials say it’s not entirely clear how that would work. It’s also possible that whatever exemptions the department could implement could be withdrawn by a later administration.

Still, something needs to be done, according to scientists and industry officials, who say that the existing uncertainty over how gene editing is going to be treated by regulators is holding back advances in plant breeding.

The “regulatory processes for transgenic GE crops (the so-called GMOs) are largely broken in many parts of the world,” and the use of gene editing could “provide new opportunities for innovation” with a “reduced degree of regulatory oversight,” Iowa State University scientists argued in a paper published in Plant Biotechnology Journal last year.

“If we’re faced with a regulatory landscape that’s similar to what we see in transgenics that means a lot of companies won’t be able to play in that arena,” said Bernice Slutsky, senior vice president of domestic and international policy for the American Seed Trade Association. “There’s a lot of promise there and there’s research being done, but in terms of actively moving it forward it really depends on what happens from a policy perspective.”

Another potential issue is how USDA would interpret its authority to analyze the potential of new biotech crops to become “noxious weeds.” The Plant Protection Act, which is the basis of USDA’s regulatory authority for biotech crops, lays out a broad definition of “noxious weed” that includes a plant or plant product that could harm not just agriculture but also the “natural resources of the United States, public health or the environment.”

Critics of biotechnology, citing the language in the Plant Protection Act, want the department to consider those broader concerns in analyzing the risks of new biotech crop.

The biggest question of all may be when, or even if, the department ever implements this overhaul. It could take years to finalize the plan.

USDA officials have said that the administration wants to issue a proposed rule for the new regulatory system before the fall. But even getting it done by next January, when Obama leaves office, would be a heavy lift. And it would still be up to the new administration whether to actually implement the plan.

The industry and other stakeholders have been given 30 days to comment on the current document, but they plan to ask for at least 60 days more. Industry and farm groups also are planning to meet in the next week or two to discuss how to address the USDA proposal.


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