Yesterday, OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a request for information from USDA’s Animal and Plant Health Inspection Service (APHIS) on “Request for Information: Regulation of Biotechnology”. The RFI was submitted to OIRA to March 30th, 2026.
The RFI was not listed in the Spring 2025 Unified Agenda, but that is not unusual for RFI’s. It looks like this may be in response to the December 2, 2024 vacatur of the 2020 biotechnology regulations (7 CFR 340). While APHIS has resumed enforcing the biotechnology permitting and Am I Regulated processes, this may be an initial step in rewriting the vacated regulations. If that is the case, this is more like an advanced notice of proposed rulemaking than a pure ‘request for information’.
Since much of the ‘technology’ in biotechnology manufacturing is identical to that used in chemical manufacturing, I would expect to cover biotechnology manufacturing issues and regulations in this blog.
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