USDA/APHIS issues Regulatory Status Review Responses: Infinite Enzymes, Inc., corn and J.R. Simplot potato

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) recently reviewed a corn and potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted Regulatory Status Review (RSR) responses on its website as required under 7 CFR part 340.

The corn plant from Infinite Enzymes, Inc. was modified to produce the enzyme manganese peroxidase in corn seed. It was also modified to make it resistant to the herbicide glufosinate. The potato plant from J.R. Simplot Company was modified to make it resistant to potato late blight and potato virus Y. It was also modified to alter potato tuber sugar profile and quality.

In both cases, APHIS found these plants unlikely to pose an increased plant pest risk compared to other cultivated corn and potato plants. As a result, they are not subject to regulation under 7 CFR part 340. From a plant pest risk perspective, these plants may be safely grown and used in breeding in the United States.

The RSR requests can be viewed from Infinite Enzymes, Inc. and J.R. Simplot and APHIS’ response letters on the APHIS website. APHIS' responses are based on information from the developers and APHIS':

• familiarity with plant varieties,

• knowledge of the traits, and

• understanding of the modifications.

Under 7 CFR part 340, developers may request a RSR when they believe a modified plant is not subject to regulation. APHIS reviews the modified plant and considers whether it might pose an increased plant pest risk compared to a nonregulated plant. If APHIS' review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS issues a response indicating the plant is not subject to the regulations.