On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register (82 Fed. Reg. 51582) stating that it was withdrawing its January 19, 2017, proposed rule on the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms to “update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by [GE] organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks” (82 Fed. Reg. 7008). Citing comments on the proposed rule critical of the proposed revisions, USDA stated it is committed to “explor[ing] a full range of policy alternatives” instead, and that it will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” More specific comments from USDA and the reasons supporting its decision are set forth in the notice.
While it appears that some in industry may welcome the withdrawal, most would agree that all stakeholders should work collaboratively and quickly to develop a new framework to speed the process to market, and to ensure the regulatory landscape is more efficient and clearer than it currently is. USDA and pertinent others should immediately begin another process to enable the regrouping to begin.