BSL-4 Lab Worker - Photo Credit –USAMRIID
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During the first half of 2012, the big infectious disease story was the ongoing debate over H5N1 genetic research by Yoshihiro Kawaoka and Ron Fouchier which each led to the creation of a mammalian-adapted, easily transmissible form of the bird flu virus.
After prolonged, and often heated debate, the decision to publish both papers was finally made, but what was intended to be a 60 day self-imposed moratorium on similar research – implemented in February of 2012 – remains in place.
Many unresolved issues surround how projects determined to be DURC – Dual Use Research of Concern – should be handled. For those unfamiliar with the lexicon of biomedical research, DURC is defined as:
. . . life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
Last March the Office of Science Policy at the NIH released a 4 page set of guidelines for DURC projects, and ordered a review of all current life sciences projects (U.S. Issues New DURC Oversight Rules), but there remain many areas ripe for debate.
In a attempt to gauge public sentiment, the HHS has published in the Federal Register a Request For Information And Comment that will remain open for the next 60 days.
Influenza Viruses Containing the Hemagglutinin from the Goose/Guangdong/1/96 Lineage
A Proposed Rule by the Health and Human Services Department on 10/17/2012
Summary
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information and comments from the public to questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. This information will be considered in a determination of whether such viruses should be listed as HHS select agents, by revising the HHS Select Agent Regulations (42 CFR Part 73).
The HHS oversees the CDC’s Select Agent Program, which today `oversees the activities of possession of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products’.
Recently,we saw the SARS Virus Placed On Select Agents List, which essentially dictates who, and under what laboratory security conditions, can conduct experiments with that virus.
Returning to the Federal Register.
DATES: Back to Top
Electronic or written comments should be received on or before December 17, 2012.
ADDRESSES: Back to Top
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.
DURC encompasses far more than just H5N1 research. For more on the issues, the NIH produced this 7 minute video in 2010 highlighting the concerns of DURC, called Dual Use Research: A dialogue. Click the link, or the image below to watch.
