APHIS Draft Guidance for Regulatory Status Review Request Available for Public Comment

  • On September 16, 2021

Late last month, USDA Animal Plant Health Inspection Service (APHIS) published for public comment a proposed guidance to requesting a regulatory status review (RSR) under the revised biotechnology regulation in 7 CFR part 340. The guidance specifies the types of information to be submitted to support the Agency’s determination of regulatory status – in essence, whether the modified plant presents a novel plant pest risk. The RSR process is currently available for corn, soybean, cotton, potato, tomato and alfalfa and will be expanded to include all other crops on October 1 of this year.

On September 21, APHIS will host a webinar and provide opportunities for questions on the draft RSR guidance. The Federal Register notice can be viewed and comments can be submitted here. The public comment period ends on October 25. ASTA’s Plant Breeding Innovation Working Group will be providing comments.