Guidance on Requests for Extensions of Non-Regulated Status

Guidance on Requests for Extensions of Non-Regulated Status

On February 22, 2016, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of new guidance for extension requests for genetically engineered (GE) organisms.  

APHIS had stated at its annual stakeholder meeting on November 18, 2015, its plans to streamline and standardize the agency's process for extending deregulations for GE organisms.  

APHIS deregulates GE products subject to its regulations when we determine they do not pose a plant pest risk.  APHIS extends a deregulation to a new GE organism when we determine it is sufficiently similar to a previously reviewed organism that was deregulated.  When considering whether to grant a deregulation by extension, our analysis is primarily aimed at evaluating similarity and identifying any new issues that may be relevant to our regulatory decision.

APHIS reviewed the current extension process and identified areas that could be refined, leading to a timelier, more efficient and predictable process.  The new guidance is based on our experience and learning related to risks presented by various crops and traits, and interprets more flexibly the authorities in 7 CFR §340.6(e).

By taking these steps, APHIS can deliver a more predictable process for considering and acting on product deregulations while still providing rigorous scientific reviews and decision-making. APHIS anticipates being able to make a decision on extension requests in less than eight months for most requests, shortening the time it takes to bring new products to farmers, and fostering innovation.  

The process improvements to APHIS' review of a GE extension request support USDA efforts to become a high-performing organization, by identifying key actions and initiatives aimed at improving the public’s experience, modernizing and streamlining processes, reducing costs, accelerating delivery and using innovative technology to advance public service.


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