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USDA Deregulates Corn Amylase

USDA Deregulates Corn Amylase


The USDA’s Animal and Plant Health Inspection Service (APHIS) is announcing its decision to deregulate corn genetically engineered (GE) to produce a common enzyme called alpha-amylase that breaks down starch into sugar, thereby facilitating a vital step in ethanol production.

“APHIS conducted a plant pest risk assessment and found this line of corn does not pose a plant pest risk, and should no longer be subject to regulation by APHIS,” says Michael Gregoire, deputy administrator for APHIS' biotechnology regulatory services. “APHIS’ deregulation decision is based on the findings of our plant pest risk assessment and environmental assessment.”

Syngenta Seeds, Inc., requested that APHIS grant nonregulated status to its alpha-amylase corn (Event 3272) in 2005. In 2008, APHIS prepared a plant pest risk assessment as required by the Plant Protection Act and an environmental assessment in accordance with the National Environmental Policy Act. Both documents were made available for public review and comment, and APHIS received more than 13,000 comments.

APHIS recognizes that certain milling and food-processing stakeholder groups have concerns about this corn variety being deregulated and potential impacts on wet-milling operations. We are pleased that these segments of industry continue to dialogue with Syngenta on research and testing efforts, and encourage these parties to continue their efforts to resolve the issues that remain.

Syngenta has committed to several important steps to address some stakeholder concerns, such as forming an industry advisory council to review the closed loop system the company has in place for amylase corn. Syngenta has invited USDA to be a part of the council, and USDA will participate. Syngenta is also willing to share information on amylase corn production, within appropriate legal and privacy limits, with members of the advisory council.

APHIS has regulated this line of corn through its notification and permitting process since 2002. The corn successfully completed the U.S. Food and Drug Administration’s food/feed safety consultation in August 2007.

 Notice of this decision will be published later in the Federal Register.

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