OMB Approves APHIS Biotech Regulation RFI

 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. 

APHIS Sends Biotechnology RFI to OMB

On Monday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a request for information (RFI) notice from the USDA’s Animal and Plant Health Inspection Service (APHIS) on “Regulation of Biotechnology”. This RFI was not listed in the Spring 2025 Unified Agenda, but most RFI’s are not listed.  

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. 

Review – Committee Hearings – Week of 4-6-25

With both the House and Senate in Washington there is a relatively normal level of Committee hearings scheduled for this week. In the House we have a biotechnology hearing and two markup hearings of potential interest here. In the Senate we have a space geek hearing and a look at daylight savings time (okay not a topic here, but interesting none-the-less).

Biotechnology Report

On Tuesday, the Subcommittee on Cyber, Information Technologies, and Innovation of the House Armed Services Committee will hold a hearing on “Final Report of the National Security Commission for Emerging Biotechnology”.

Markup Hearings

On Wednesday, the House Foreign Affairs Committee will hold a business meeting that will consider eight bills, including an as of yet unintroduced “To provide for control of remote access of items under the Export Control Reform Act of 2018.”

On Wednesday, the House Homeland Security Committee will hold a business meeting that will consider twelve bills, including an as of yet unintroduced “Strengthening Cyber Resilience Against State-Sponsored Threats Act”.

Space Geek Hearings

On Wednesday, the Commerce, Science, and Transportation Committee will hold a nomination hearing with testimony from Jared Isaacman who is being considered for the position of Administrator of the National Aeronautics and Space Administration.

 

For more information on these hearings, including a brief commentary of House floor actions this week, see my article at CFSN Detailed Analysis - https://patrickcoyle.substack.com/p/committee-hearings-week-of-4-6-25 - subscription required.

Review - Biotechnology EO Includes Cybersecurity Requirements

Today the White House published an executive order in the Federal Register (87 FR 56849-56860) on “Executive Order 14081--Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy”. EO 14081 includes cybersecurity requirements for both protection of biotechnology information and equipment.

In Section 1(j) of the order, the President clarifies that one of the objectives of the National Biotechnology and Biomanufacturing Initiative is protecting the United States bioeconomy “by adopting a forward-looking, proactive approach to assessing and anticipating threats, risks, and potential vulnerabilities (including digital intrusion, manipulation, and exfiltration efforts by foreign adversaries), and by partnering with the private sector and other relevant stakeholders to jointly mitigate risks to protect technology leadership and economic competitiveness”.

Commentary

What is missing here is an assessment of whether this new bioeconomy will end up providing potential terrorist targets similar the potential chemical facility targets covered in the Chemical Facility Anti-Terrorism Standards. In the CFATS program, covered facilities are assessed to be at high-risk of terrorist because of the risk of release during a terrorist attack or because the chemicals at the site can be used as chemical weapons or precursors to explosives or chemical weapons. Someone needs to determine if there are similar bio-risks associated with the new biotechnology manufacturing facilities.

In passing, just a reminder that a biotech manufacturing facility can be subject to the security requirements of the CFATS program if they maintain an inventory above screening threshold quantities of any of the 300+ DHS chemicals of interest (COI).

For more details about the cybersecurity provisions of the EO, see my article at CFSN Detailed Analysis - https://patrickcoyle.substack.com/p/biotechnology-eo-includes-cybersecurity - subscription required.