FAQs: Biological Surety and BSAT
We hope you find our answers to these frequently asked questions about biological surety and BSAT helpful.
Q: What is biological surety?
A: Biological surety, or biosurety, is primarily a Department of Defense (DoD) program to safeguard biological select agents and toxins (BSAT) from theft and misuse while ensuring that BSAT work is conducted safely. Compliance relies on three main programs: personnel reliability, security and safety.
The primary regulations that govern these programs are:
- AR-50-1* - Biological Surety
- AR 190-17 - Biological Select Agents and Toxins Security Program (can only be viewed through Army Knowledge On-Line, available to Army personnel)
- DA Pam 385-69* - Safety Standards For Microbiological and Biomedical Laboratories
Q: What is BSAT?
A: Biological select agents and toxins (BSAT) is the Army’s term for what the CDC and USDA define as select agents. (CFR references: 7 CFR Part 331, 9 CFR Part 121 and 42 CFR Part 73.) Army BSAT is any BSAT that is provided as Government Furnished Equipment (GFE) to a subcontractor from the DoD or acquired by a subcontractor under a cost-reimbursable contract that becomes Contractor Acquired Property (CAP).
Q: Why is BSAT important?
A: Compliance with biological surety helps to safeguard BSAT from potential threats, both external threats through the implementation of enhanced security measures, and insider threats through the personnel reliability program. For DoD contractors, either currently working with BSAT or planning to bid on government contracts where BSAT use is required, compliance with biological surety is required in order to be eligible to bid.
The July 2, 2010 Executive Order - Optimizing the Security of Biological Select Agents and Toxins in the United States requires enhanced and harmonized safeguards at facilities that use select agents.
Q: Under what circumstances is biosurety compliance required?
A: Currently, Army BSAT is any BSAT that is provided to a subcontractor as Government Furnished Equipment from the DoD or acquired by a subcontractor under a cost-reimbursable contract that becomes Contractor Acquired Property. Compliance is required for any DoD-funded program that uses BSAT. More detail: FAR 52.245-1
Q: What has DVC learned in the course of implementing BSAT?
A: We've learned that:
- Compliance is a process and requires partnership with the DoD. To have a fully compliant program requires a personnel reliability program, which can only by vetted by a government employee appointed as the Certifying Official. Additionally, biological surety is a new program, so standards, and compliance with those standards, are still evolving.
- Full compliance requires a partnership with the Government because they are the only ones that can certify BSAT workers into the reliability program.
- Full compliance requires a comprehensive understanding of all three areas: personnel reliability, security and safety.
- Compliance requires an understanding of the requirements as written, which are often difficult to decipher without the benefit of advice from experts in the field.
Q: How can DVC help with BSAT compliance?
A: Biological surety is a relatively new program for the DoD and when the regulations were drafted, they were written for government/military facilities. These regulations can be difficult to interpret and thus difficult to translate into action.
DVC has been successful at implementing a BSAT program that satisfies the requirements of the U.S. Government, and can lend our experience to help interpret and implement the regulations to meet regulatory expectations and client requirements.
To talk with DVC about how we can assist with your BSAT needs, please contact us.
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Related Links
Review a presentation on BSAT (702K, PDF), by Kenneth A Cole, Ph.D., CAPT. MSN, U.S. Navy, to the National Science Advisory Board for Biosecurity (NSABB).
Read a recent journal article: Everywhere You Look: Select Agent Pathogens.
Read a book: Managing BSAT Research and the Select Agent Program.
These FAQs were featured in the April 5, 2011 edition of DVC's free email newsletter. Check out past editions, and subscribe today!