It will be 2018 at the earliest before the Department of Agriculture finishes an overhaul of its regulations on GMOs

EXCERPT: Several industry members expressed anxiety at the long period of uncertainty that this time line will entail.
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Overhaul of GMO rules to be long, hard slog, USDA says

By David Schultz
Bloomberg BNA, 18 Nov 2015
http://www.bna.com/overhaul-gmo-rules-n57982063724/

Though it began its process in February of this year, it will be 2018 at the earliest before the Department of Agriculture finishes an overhaul of its regulations on genetically modified organisms, according to the department's top biotechnology regulator.

Michael J. Firko, head of the USDA Biotechnology Regulatory Services (BRS), said three years from now is the best-case scenario for completion of this initiative on GM crops.

The protracted timeline is a function of the upcoming change in presidential administrations combined with the inherent complexity of federal rulemaking in today's political climate, Firko told a room of biotech industry representatives Nov. 18 at an annual USDA conference.

Several industry members expressed anxiety at the long period of uncertainty that this time line will entail.

Daphne Preuss, chief executive officer of the startup biotech company Chromatin, said it will be impossible for her company to attract investment if she won't be able to tell potential investors how — or even whether — her products will be regulated by the USDA until near the end of this decade.

“I shut down a project when the USDA announced these regulatory changes,” she told Bloomberg BNA.

Ultimately, the USDA's new regulatory regime may end up being more favorable to the biotech industry than the current one.

New "Regulatory Trigger" Planned

Firko said one of the goals of this initiative is to create a new “regulatory trigger” for genetically modified crops. Currently, if a bioengineer uses a known plant pest to develop a new crop, that triggers regulatory oversight from Firko's team.

This trigger was developed in the 1980s at the dawn of agricultural biotechnology. Advances in science since then have made it clear, Firko said, that his team is now scrutinizing crops that pose no risks simply because a plant pest was involved in their inception (168 DEN B-1, 8/31/15).

“We need to be not worrying so much about things we're pretty sure don't pose a risk and capturing the very small amount of things that we think do pose a risk but are not captured by the regulations,” he said.

This could mean that companies would be spared much of USDA's costly and time-consuming regulatory gantlet for GM crops that are created with already existing technology.

“We spend a lot of time reviewing the same things over and over — very familiar traits and very familiar crops,” John Turner, the head of BRS's risk analysis program, said. “Is there a way to leverage this work?”

Time Pressure

But the USDA is a long way from finalizing — or even from formally proposing — what this new regulatory trigger would look like.

Firko said that next month his agency will begin a programmatic environmental impact study to look at the potential effects of several different options for the regulatory overhaul.

Then, in late summer, Firko said USDA expects to formally publish a proposed rulemaking that would lay out exactly how the department would like to change its regulations.

Firko said Agriculture Secretary Tom Vilsack told him that this step had to take place no later than August to prevent this initiative from becoming an issue in the ensuing presidential election.

After the proposed rulemaking, a lengthy comment period will follow, and, by the time this concludes, a new president will be in office or will be close to taking office. With most new presidents typically taking six months to a year to finish prioritizing their agenda, it's likely that the biotech overhaul initiative will be put on ice for most if not all of 2017, Firko said.

Pressing Issues

Until this new regulatory regime is in place, Firko's division has several pressing GMO issues it needs to address.

Chief among them is responding to two recent incidents in which unapproved GM wheat was found growing in fields in Oregon and Montana. In response to these incidents, Firko said his office is imposing tighter restrictions on field trials of GM wheat and is beginning to hire dozens more staff members who will be responsible for compliance and oversight (187 DEN A-14, 9/28/15).

Firko also shared new details of the ramifications these two incidents had.

He said that, after the discovery of unauthorized GM wheat in Montana, Sen. Jon Tester (D-Mont.) requested a Government Accountability Office review of his office's GMO approval process. This GAO review is nearing completion, Firko said.

U.S., Japanese Negotiations

After the incident in Oregon, Firko said he spent several days in a room with Japanese agriculture officials pleading with them not to impose a ban on all imports of wheat from the U.S.

The new restrictions on field trials of GM wheat are, in part, a way to reassure foreign trading partners that the U.S. can prevent GMO contamination of wheat and other crops.