The government needs your input, according to the Department of Health and Human Services and the Centers for Disease Control and Prevention. In a federal register posting, the CDC is requesting public comments regarding the highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage. These comments will be used in addition to accepted metrics by which select agents are judged, and the comments could include research data if it will help inform the CDC.
Currently, all HPAI H5 subtype viruses (H5N1) are regulated by the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) whose oversight focuses on the threat to animal health and safety. Listing influenza viruses that contain an HA from the goose/Guangdong/1/96 lineage as an HHS select agent will ensure that the focus of regulation will also be on the potential impact of these viruses on human health as well as agriculture.
The questions posed to the public are:
(1) Do HPAI H5N1 influenza viruses containing the HA from the Goose/Guangdong/1/96 lineage pose a severe threat to public health and safety?
(2) Are there other influenza strains containing HA from Goose/Guangdong/1/96 lineage that would also pose a severe threat even if they were not fully of HPAI H5N1 origin?
(3) Are there any other HPAI H5N1 influenza strains that have been identified to pose a severe threat to public health and safety?
(4) Should these viruses be regulated as HHS select agents?
(5) If these viruses should be regulated as HHS select agents, should these viruses be designated as Tier 1 select agents?
(6) Should special precautions (i.e., safety and containment measures) be considered when working with diagnostic specimens suspected of containing HPAI H5N1 influenza viruses containing the HA from the Goose/Guangdong/1/96 lineage (i.e., any precautions versus none at all, precautions beyond those usual for clinical samples and/or laboratory microbes, etc.)? and
(7) Should special precautions (i.e., safety and containment measures) be considered when working with strains of HPAI containing the HA from the Goose/Guangdong/1/96 lineage that have been shown to be transmissible between mammals beyond those recommended for non-mammalian transmissible HPAI
You may submit comments identified by Docket Number CDC–2012–0010, by any of the following methods:
• Federal eRulemaking Portal: http:// www.regulations.gov – Follow the instructions for submitting comments.
• Mail: Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop A–46, Atlanta, Georgia 30333, Attn: Docket Number: CDC–2012–0010. Instructions: All submissions received must include the agency name and docket number (CDC–2012–0010) for this notice. All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to www.regulations.gov.