http://cryptome.org/cdc102005.txt
FOR FURTHER INFORMATION CONTACT: Mark Hemphill, Chief of Policy,
Division of Select Agents and Toxins, Centers for Disease Control and
Prevention, 1600 Clifton Rd., MS E-79, Atlanta, GA 30333. Telephone:
(404) 498-2255.
SUPPLEMENTARY INFORMATION: The complete coding sequence for the 1918
pandemic influenza A H1N1 virus has been recently identified
(Taubenberger et al., 2005, Nature, vol. 437, pp. 889-893). Scientists
from the Centers for Disease Control and Prevention together with
collaborators at Mount Sinai School of Medicine, NY, Armed Forces
Institute of Pathology, MD, and Southeast Poultry Research Laboratory,
U.S. Department of Agriculture, GA, reconstructed the 1918 pandemic
influenza virus by using reverse genetics to study the properties
associated with its extraordinary virulence (Tumpey et al.,
Characterization of the Reconstructed 1918 Spanish Influenza Pandemic
Virus, Science 2005 310: 77-80). With the publication of the complete
coding sequence, it will be possible for other scientists with
knowledge of reverse genetics technology to reconstruct the 1918
pandemic influenza virus at other institutions.
The pandemic influenza virus of 1918-19 killed up to 50 million
people worldwide, including an estimated 675,000 deaths in the United
States. The 1918 pandemic influenza virus' (H1N1) most striking feature
was the unusually high death rate among healthy adults aged 15 to 34
years. The question of whether the reconstructed 1918 pandemic
influenza virus should be regulated as a select agent was considered by
the Intragovernmental Select Agents and Toxins Technical Advisory
Committee (ISATTAC). The criteria used by the ISATTAC for reviewing the
reconstructed 1918 pandemic influenza virus for inclusion on the select
agent list were: degree of pathogenicity, communicability, ease of
dissemination, route of exposure, environmental stability, ease of
production, ability to genetically manipulate or alter, long-term
health effects, acute morbidity, acute mortality, available treatment,
status of immunity, vulnerability of special populations, and the
burden or impact on the health care system. Based on these criteria,
the ISATTAC determined that the reconstructed 1918 pandemic influenza
virus could pose an immediate severe threat to public health and safety
if it is not safely and securely maintained. Further, the ISATTAC noted
that the biological and molecular properties that enabled the 1918
pandemic influenza virus to cause such widespread illness and death are
not completely understood and that it is not known how virulent the
reconstructed virus would be in the population today. In making its
determination, the ISATTAC considered both the historical data
regarding the original 1918 pandemic influenza virus and data from
current in vitro and in vivo animal studies. The apparent virulence of
this virus, together with the fact that the level of immunity in the
general population and the ability of the virus to readily transmit
among persons are unknown at this time, makes it prudent to immediately
regulate this virus as a select agent. Although studies with this virus
can lead to significant public health benefits for understanding
pandemic influenza, improved diagnostics, and the development of more
effective countermeasures, there are also potential risks of the misuse
of this agent for purposes of bioterrorism as well as accidental
release. Thus, if misused, the 1918 pandemic influenza virus may pose a
biological threat to public health and/or national security.
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) requires the regulation of
each biological agent that has the potential to pose a severe threat to
public health and safety. Congress recognized that a delay in the
regulation of such biological agents was contrary to the public
interest by requiring in the Bioterrorism Act that the initial Select
Agent regulations be promulgated as an interim final rule. Therefore,
the Secretary has determined that prior notice and opportunity for
public
[[Page 61048]]
comment are contrary to the public interest and there is good cause
under 5 U.S.C. 553 for making this rule effective less than 30 days
after publication in the Federal Register. We will consider comments
that are received within 60 days of publication of this rule in the
Federal Register. After the comment period closes, we will publish
another document in the Federal Register. The document will include a
discussion of any comments we receive and any amendments that will be
made to the rule as a result of the comments. In addition to seeking
comments on the addition of this agent to the HHS list of select agents
and toxins, we are also seeking comments on the regulation of
reconstructed viruses that contain less than all eight gene segments
from the 1918 pandemic influenza virus and if there are certain
experiments with such constructs or with the fully reconstructed 1918
pandemic influenza virus that should be added to the ``Restricted
experiments'' provisions of the regulation.
An entity must apply to the CDC Division of Select Agents and
Toxins to possess, use, or transfer reconstructed replication competent
forms of the 1918 pandemic influenza virus containing any portion of
the coding regions of all eight gene segments. The CDC Division of
Select Agents and Toxins will review the entity's biosafety plan to
ensure that it provides a comprehensive risk assessment of the proposed
research and adequately ensures appropriate biosafety measures. The CDC
Division of Select Agents and Toxins will conduct a biosafety review of
proposed experiments with the reconstructed 1918 pandemic influenza
virus on a case-by-case basis. The ``Interim CDC-NIH Recommendation for
Raising the Biosafety Level for Laboratory Work Involving
Noncontemporary Human Influenza Viruses'' excerpted from the draft CDC/
NIH Biosafety in Microbiological and Biomedical Laboratories, 5th
edition will be used as the minimum containment for such experiments.
However, in some cases supplemental biosafety measures may be deemed
appropriate after review of the proposed experiments.
The case-by-case review by CDC's Division of Select Agents and
Toxins will continue until further data are available that may result
in changes to biosafety guidelines for work with the reconstructed 1918
pandemic influenza virus. Until such revised guidelines are available,
entities should refer to the ``Interim CDC-NIH Recommendation for
Raising the Biosafety Level for Laboratory Work Involving
Noncontemporary Human Influenza Viruses.'' In accordance with these
interim guidelines, work with such viruses should proceed with extreme
caution and the viruses should be handled, at a minimum, under high-
containment (Biosafety Level 3-enhanced) laboratory conditions.
Enhancements should include the use of powered air purifying
respirators, change-of-clothing and shower-out requirements, use of
HEPA filtration for treatment of exhaust air, and a stringent medical
surveillance and response plan. In addition to these currently
published interim guidelines, annual vaccination with the currently
licensed influenza vaccine is strongly recommended and antiviral
prophylaxis should be available for individuals working with
reconstructed replication competent forms of the 1918 pandemic
influenza virus containing any portion of the coding regions of all
eight gene segments.
The addition of the 1918 pandemic influenza virus to the HHS select
agents and toxins list is effective immediately. Entities that intend
to possess, use, or transfer this agent will be required to either
register in accordance with 42 CFR part 73, or amend their current
registration in accordance with Sec. 73.7(h).
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