WASHINGTON, Dec. 11, 2015 – USDA’s Animal and Plant Health Inspection Service (APHIS) announced today that as of Jan. 1, it will require developers of genetically engineered wheat varieties to apply for permits before conducting field trials.

The agency told stakeholders its decision to employ a “more stringent permit process” – over the current notification process – “will provide added protection that GE wheat will not persist in the environment after field trials are concluded, and will remain confined during the trials.”

In 2013 and 2014, regulated GE wheat developed by Monsanto was found growing in Oregon – where field trials of GE wheat were never authorized – and in Montana – where the last authorization for a field trial of GE wheat had expired over 10 years ago. The wheat found at both locations contained Monsanto’s glyphosate resistant trait MON71800, but were genetically different.

“It became clear to us following the GE wheat incident in Oregon that the detection of regulated GE wheat where it was not authorized, had great potential to disrupt wheat markets globally,” APHIS said in its justification statement, adding that some trading partners “continue to apply additional risk mitigation measures” to imports of U.S. wheat in response to the 2013 incident.

The permit reporting requirements will help reassure trading partners “that the U.S. is committed to being the world’s reliable supplier of grain,” the agency said.

APHIS said the change would affect “a small number of regulated activities and about a dozen applicants.” For context, APHIS authorized 21 field trial authorizations for GE wheat in 2014.

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By using a permit system, as opposed to a notification system, APHIS can now apply site-specific requirements, such as longer volunteer monitoring periods with specific reporting requirements in dry-land agriculture with no tillage. And unlike notifications, APHIS said, greater monitoring of volunteer plants (plants that grow following a harvest) and reporting requirements under permits will “help both the permittee and APHIS collect relevant data to employ and evaluate risk-based confinement conditions.”

APHIS closed a month-long public comment period on its proposal to strengthen oversight of field trials for GE wheat on Oct. 26.

Steve Mercer, vice president of communications with U.S. Wheat Associates, told Agri-Pulse that his organization "had frank discussions with APHIS" about the change during the agency's comment period and "appreciated" the hearing it received. The change will "provide additional, useful assurance to our overseas customers that biotech field trials in the United States are responsibly managed," Mercer added.

Gordon Stoner, vice president for the National Association of Wheat Growers, said the new rule imposed an "unnecessary" and "potentially burdensome" regulatory hurdle. “There is no commercially available GE wheat in production, no GE wheat in any export channels, and no GE wheat varieties currently awaiting APHIS deregulation," Stoner said, "so having USDA-APHIS categorize future GE wheat research field trials for added scrutiny is both puzzling and potentially inhibiting for those seeking much needed public and private research investments.”

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