Monsanto Withdraws Biotech Wheat Regulatory Submissions

FDA will still confirm the food and feed safety of Roundup Ready wheat. Compiled by staff

Published on: Jun 18, 2004

Consistent with Monsanto's recent announcement to defer the commercialization of Roundup Ready wheat so that they can focus on other crops and traits, the company has formally withdrawn all regulatory submissions in all countries where submissions have taken place, except the United States Food and Drug Administration (FDA).

Monsanto has requested completion of the U.S. FDA consultation to confirm the food and feed safety of Roundup Ready wheat. This action is supported by the American wheat and food industry, and the submission is technically complete, requiring minimal agency resources to complete.

Since the wheat will not be grown in the U.S., the U.S. Department of Agriculture regulatory review is no longer necessary and so Monsanto has withdrawn their regulatory submission to that department.

"Monsanto's follow-up announcement gives finality to their earlier decision on Roundup Ready wheat," said Alan Tracy, president of U.S. Wheat Associates. "We appreciate that FDA will complete its reviews of health aspects of Roundup Ready wheat, so that the concerns of critics can be answered."

Officials from Monsanto told USW that the decision was based on discussions with all of the relevant regulatory authorities, who mutually agreed that withdrawing the submissions is the appropriate course of action at this time. These actions are in keeping with Monsanto's recent announcement to defer commercial development of Roundup Ready wheat until other biotechnology traits in wheat are introduced.