Thursday, September 15, 2022

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”.


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 - - subscription required.

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