July 28, 2015—Gregory Demske, Chief Counsel to the Inspector General in testimony before a US House of Representatives Committee on Energy and Commerce Subcommittee delivered a shocking statement. Since the passage of the Bioterrorism Act of 2002 the Office of the Inspector General (OIG) investigated 68 Select Agent Program enforcement concerns involving 53 unique organizations, all based on requests from the U.S. Centers for Disease Control and Prevention. The findings are absolutely staggering:
- 30% of the organizations referred to the OIG were federal entities.
- 33% of these federal entities received Notice of Violation Letters from the OIG.
- 17% of the OIG identified violations occurred at federal laboratories.
Since 2004 the number of commercial, federal, academic and private biological containment labs has skyrocketed by over 260%. If you believe the United States government is tracking the activity of each lab, you are, unfortunately, sadly mistaken. The problem gets much more complex, as globally, there is virtually no reliable tracking in place.
The Government Accountability Office recently warned Congress that the increased number of containment labs is leading to greater risk of dangerous mistakes, accidents and outright sabotage. This admonition is warranted as the GAO states in their 2014 report entitled Recent Incidents of Biosafety Lapses “…the oversight of these laboratories is fragmented and largely self-policing.”
“For more than 30 years, I have listened to the biosecurity debate in meetings large and small. Assurances have been made…My worries are not appeased, my nerves are not calmed, and yours ought not be either. ”
US Government agencies including the National Institutes of Health (NIH), the U.S. Centers for Disease Control and Prevention (CDC), the Department of Defense (DoD) and the Department of Agriculture (USDA) operate containment labs across the country. If you are responsible for managing any of these facilities or even a single lab within one of these buildings, you do not want to come under the scrutiny of the Occupational Safety and Health Administration (OSHA), the CDC Select Agent Program or the Office of the Inspector General. Just one incident of poor practices, a lapse in safety or a single security incident can expose you to scrutiny—especially if that incident was preventable.
Sadly, every year thousands of avoidable incidents occur. Labs are placed into “Performance Improvement Programs”, resulting in a loss of employee confidence, a concerned public and a furious government.
“These events should never have happened. The American People may be wondering whether we’re doing what we need to do to keep them safe and to keep our workers safe. I’m disappointed, and frankly I’m angry about it”
CDC Director Thomas Frieden
The Washington Post
July 11, 2014
Director Frieden established a group to review and approve safety on a “lab-by-lab” basis, but the fact is the cost is much greater when attempting to repair damage rather than taking steps to prevent it.
Would you prefer to have increasing budget appropriations for your federal lab due to superior performance and an exemplary safety record, or would you rather be called before Congress to explain the lax practices of your laboratory just before your replacement is appointed?
- Does your program have a dedicated full-time credentialed biological safety officer or just an individual with biosafety duties as an additional assignment?
- Does this individual have excellent rapport with scientists, security staff and senior management or does this individual hide out in their office all day with little interaction?
- Have all your program’s administrative controls been formally reviewed in the past year?
- Does the organization actively manage a safety training program and track the attendance and performance improvement of staff?
Inspirion Provides Highly Qualified & Credentialed Experts In All Areas Of Biosafety
With only 1 accredited biosafety professional per 500 containment labs in the United States, many facilities lack the staff to perform a comprehensive review of their BioRisk Management Program. Even in-house reviews are easily tainted by “insider’s myopia”.
Inspirion will help with the creation, delivery and implementation of Standard Operating Procedures, even recruiting and training your Biological Safety Officer. We ensure you are prepared for any Select Agent Program inspections and will assist you in maintaining compliance between inspections.
If you fear your program suffers from any of these risks, you need to contact us today.