sharon sanders
Editor-in-Chief & President
[h=1]Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins[/h] A Proposed Rule by the Health and Human Services Department on 07/16/2015
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.
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Based on the public comments to the RFI and in consultation with the ISATTAC, we are proposing a tiered approach to the regulation of influenza viruses containing the HA from the A/Gs/Gd/1/96 lineage.
Under our proposal, influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage, including wild-type and laboratory-derived viruses, will be regulated as a non-Tier 1 select agent. This designation recognizes the public health threat posed by the high mortality rate, lack of a readily available vaccine, and the absence of immunity in the population.
The USDA regulates avian influenza virus, although the USDA regulations exclude any ?low pathogenic strains of avian influenza virus . . . provided that the individual or entity can identify that the agent is within the exclusion category? (Ref 13). Accordingly, all reported human infections with influenza viruses containing the HA from the A/Gs/Gd/1/96 lineage are considered to be HPAI by the USDA and therefore are regulated as select agents by USDA. However, influenza subject matter experts have indicated that there is a possibility that influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage could be classified as LPAI, as a result of mutation or genetic manipulation and yet cause severe disease in humans. Under the current paradigm, these strains would not be regulated as select agents. Our regulatory strategy would address this potential gap in select agent oversight. We do not anticipate this listing to have a significant impact on the select agent stakeholder community as most entities working with this agent are already registered to work with select agents.Show citation box
We are also proposing the regulation as a Tier 1 HHS select agent 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. Designating these viruses as Tier 1 recognizes the higher public health risk posed by these viruses and establishes security requirements above those currently proscribed by the USDA for HPAI. This strategy also recognizes that HHS considers these types of experiments with these viruses to be of a significant public health concern and is consistent with recent United States Government policy regarding dual use research of concern and gain-of-function research, and the framework for ?Guiding US HHS Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets? (February 2013); and therefore warranting increased oversight (Ref 14-16). Designating these agents as HHS select agents also addresses a potential gap in current select agent oversight since laboratory-generated viruses that are capable of causing human disease do not necessarily have to be HPAI.
https://www.federalregister.gov/art...m_medium=email&utm_source=federalregister.gov
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.
snip
Based on the public comments to the RFI and in consultation with the ISATTAC, we are proposing a tiered approach to the regulation of influenza viruses containing the HA from the A/Gs/Gd/1/96 lineage.
Under our proposal, influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage, including wild-type and laboratory-derived viruses, will be regulated as a non-Tier 1 select agent. This designation recognizes the public health threat posed by the high mortality rate, lack of a readily available vaccine, and the absence of immunity in the population.
The USDA regulates avian influenza virus, although the USDA regulations exclude any ?low pathogenic strains of avian influenza virus . . . provided that the individual or entity can identify that the agent is within the exclusion category? (Ref 13). Accordingly, all reported human infections with influenza viruses containing the HA from the A/Gs/Gd/1/96 lineage are considered to be HPAI by the USDA and therefore are regulated as select agents by USDA. However, influenza subject matter experts have indicated that there is a possibility that influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage could be classified as LPAI, as a result of mutation or genetic manipulation and yet cause severe disease in humans. Under the current paradigm, these strains would not be regulated as select agents. Our regulatory strategy would address this potential gap in select agent oversight. We do not anticipate this listing to have a significant impact on the select agent stakeholder community as most entities working with this agent are already registered to work with select agents.Show citation box
We are also proposing the regulation as a Tier 1 HHS select agent 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. Designating these viruses as Tier 1 recognizes the higher public health risk posed by these viruses and establishes security requirements above those currently proscribed by the USDA for HPAI. This strategy also recognizes that HHS considers these types of experiments with these viruses to be of a significant public health concern and is consistent with recent United States Government policy regarding dual use research of concern and gain-of-function research, and the framework for ?Guiding US HHS Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets? (February 2013); and therefore warranting increased oversight (Ref 14-16). Designating these agents as HHS select agents also addresses a potential gap in current select agent oversight since laboratory-generated viruses that are capable of causing human disease do not necessarily have to be HPAI.
https://www.federalregister.gov/art...m_medium=email&utm_source=federalregister.gov