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Global Biosafety Considerations and

Gain of Function Research.

Risks and Benefits of Gain-of-Function (GOF) Research
Washington, DC
15-16 December 2014

Barbara Johnson PhD, RBP

Biosafety Biosecurity International

Incomplete Inactivation of

US CDC B. anthracis 6/2014

Beijing, China National Institute of Virology 5/2004: BSL2 laboratory analyzed SARS samples inadequately
inactivated before removal from BSL-3 lab.

No LAI or public release; breach of inactivation protocols

Two LAI, 2 secondary infections (1 fatality), 5 tertiary infections

Taiwan Institute of Preventive Medicine 2003: BSL-4 lab

improper handling of SARS contaminated waste

One LAI WHO recommendations for national biosafety


Cross Contamination of Samples

& Shipping Mix-Ups

US CDC 7/2014 LPAI contaminated with HPAI and shipped

to BSL-3 lab No LAI, theft/loss or public release/suboptimal

reporting speed

Singapore 2003: BSL-3 post-doc working with WNV

contaminated with SARS

One LAI - WHO recommendations for national biosafety


Boston University 2004 F. tularensis Live Vaccine Strain

contaminated with virulent wild type 1 confirmed, 2 probable

UK 2012 Animal and Plant Health Agency accidently ships

live B. anthracis (not inactivated)- work stop

No LAI, theft/loss or public release

LAIs are Global (2000-2011)






B. abortus

Inhalation or Tube broke in centrifuge;

inadequate PPE

Turkey/2008 & 2012

Brucella spp


Non-compliance; no use of BSC


C. psittaci



Germany/2009 & 2011



Human error


F. tularensis


Human error; unknown

USA/New Zealand
India/Ireland- 2005

M. tuberculosis


Leaky aerosol chamber

S. Africa/2009 and 2010



Human error; non-compliance

Inventory Hold-Overs

FDA site on NIH Campus July 2014

Viable smallpox found during decommissioning clean-up; other

non-registered pathogens subsequently found after Dir NIH
orders a safety stand-down and inventory accounting
All reported, disposition proper, no illness/loss/theft/release

How could this happen?

Scientists retire or move institutional material ownership

Samples remain after decades in freezer permafrost
Some are unique, valuable, patient related - knowingly saved
until everyone in the department has moved/retired
Unique to US? Will never happen again, anywhere?

US Reporting Transparency
& Resulting Actions

Dir CDC: suspension of activities- review and remediation

of all procedures; verification of adequate inactivation
procedures; strengthening of biosafety agency-wide;
external group of experts to review and advise CDC;
improvement of management of internal incidents;
investigation of root causes and personnel issues; single
point of contact to be established for biosafety issues.
Dir NIH: Operation Clean Sweep, top-to-bottom
inventory of all NIH laboratories; declared National
Biosafety Stewardship Month.
White House MFR: Enhancing Biosafety and Biosecurity
in the US (Aug 2014)

US Oversight of GOF (MERS,

SARS, influenza viruses)

Institutional level


Local level

Some (city) committees with BSL-3/4 oversight authority

National Level

Select Agent Regulations

As of Dec 14 2014, NSAR only covers SARS, HPAI, and reconstructed

replication competent forms of the 1918 pandemic influenza virus containing
any portion of the coding regions of all eight gene segments
MERS, low path avian influenza and human influenza viruses not subject to
NSAR regulatory activity


Global Observations

In a number of regions, countries have recently

established biosafety organizations & nascent
efforts make inroads in institutionalizing biosafety.
Some have national guidelines or legal frameworks,
others do not.
Oversight organizations take time to establish and
develop expertise and ability to conduct thorough
risk assessments (esp. DURC/GOF/novel agents).
Biocontainment infrastructure, biosafety and
biosecurity knowledge, training, supplies, and
capacity vary and in many areas are improving.

US & Global Considerations

Nature Editorial: July 29, 2014 many accidents are

caused not by a lack of physical barriers or regulations, but
by the absence of a strong biosafety culture in labs and their
oversight bodies.
Biosafety culture doesnt happen overnight.
Need a more robust risk assessment process and
unencumbered oversight. Must factor in indicators of
unintended consequences (i.e. mousepox x IL-4; 2001)
Can a strong/rapid response and contingency plan be
immediately implemented (local, national, international level).
Implement system for lab accident/LAI/near-miss reporting:
warn of release, lessons learned, future prevention.