Friday, July 17, 2015

HHS Seeks To Add Specific Novel Flu Lineages To Select Agents List


BSL-4 Lab Worker - Photo Credit –USAMRIID


# 10, 235


A little less than four years ago , at the 2011 ESWI Influenza Conference in Malta, Dutch researcher Ron Fouchier described the results of a groundbreaking – and later, ground shaking – experiment he’d done where he created a more `transmissible’  form of the H5N1 virus.


Katherine Harmon’s piece in Scientific American (see SciAm: What Will The Next Influenza Pandemic Look Like?) briefly touched on his work, but it was Debra MacKenzie’s article a week later (see New Scientist: Five Easy Mutations) that really called attention to this experiment.


Halfway around the globe, and at roughly the same time, news come from Yoshihiro Kawaoka, a highly respected virologist at the University of Wisconsin-Madison School of Veterinary Medicine, that he too had created an enhanced H5N1 virus in the lab.


Suddenly, alarm bells were ringing in the biosecurity community, as concerns over both accidental releases of an `enhanced’ virus, and the wisdom of publishing details that would allow others to duplicate their experiment grew.


By December of 2011 The Biosecurity Debate On H5N1 Research reached fevered pitch, which led to a group of internationally renowned Scientists to Announce a 60 Day Moratorium On Some H5N1 Research in January, 2012. That moratorium was subsequently extended until January of 2013 (see NIH Statement On Lifting Of The H5N1 Research Moratorium).


Both studies were eventually published.


In the months that followed we saw a protracted, and at times rancorous, debate over the merits and safety of so-called `Gain of Function’  (GOF) research on dangerous pathogens. GOF research involves the creation of viruses and/or bacteria with enhanced virulence, transmissibility, or host range. 


While scientists engaged in this type of work insist that the risks were negligible (see Scientists For Science: GOF Research `Essential’ & Can be Done `Safely’), many others (see Updating The Cambridge Working Group) were far from convinced.

Adding considerable fuel to the debate, in what has truly been an annus horribilis for lab safety these past 12 months, we’ve seen a large number of high-profile lab incidents involving HPAI H5N1, Anthrax, Ebola, and smallpox involving the CDC, the FDA, and Army labs. 

DOD Inadvertently Ships Live Anthrax To 9 Labs
CDC Report On Investigation Into December’s Ebola Lab Incident
CDC H5N1 Incident & Lab Safety Progress Reports
CDC: Press Conference Transcript, Audio & Timelines For Lab Incidents


These, and other lab incidents, have led to calls from major journals to improve biosafety, and to even consider blocking certain types of potentially dangerous experiments unless a substantial benefit can be shown that offsets the risks.


The Journal Nature Weighs In On Lab Accidents & Biosafety Making Viruses Deadlier – An Accident Waiting To Happen.

ECDC Comment On Gain Of Function Research


All of which serves as prelude to a Proposed Rule by the Health and Human Services Department, published  yesterday, on the  Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins.



Notice Of Proposed Rulemaking And Request For Comments.



The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is proposing to add certain influenza virus strains to the list of HHS select agents and toxins.

Specifically, we are proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. We have determined that these influenza viruses have the potential to pose a severe threat to public health and safety.

(Continue . . . )


The HHS is currently seeking comments from stakeholders and the scientific community on this proposed rule and any possible exclusions.  

From the Select Agent FAQ.

  • Select Agents are a subset of biological agents and toxins that the Departments of Health and Human Services (HHS) and Agriculture (USDA) have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products.
  • TIER 1 Agents `are a subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety’



Under this proposed rule, viruses with Hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (essentially descendents of H5N1 Clade 0), including wild-type viruses, would be considered select agents.

Laboratory modified viruses that contain the HA from the A/Gs/Gd/1/96 lineage that have enhanced respiratory transmissibility between mammals would be elevated to a Tier 1 Select Agent status.

While placement of these viruses on the Select Agents list would not prevent Gain of Function research, it would provide additional Federal oversight and require increased biosafety standards for labs doing this sort of work.  


That said, I expect this will reinvigorate the heated debate over lab safety and wisdom of doing certain types of GOF research in the coming weeks.

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