HHS Issues Select Agents
Regulation
December 20, 2002 - New regulations
governing the possession and use of biological "select
agents" at all U.S. universities and other organizations
were issued by the federal government on Dec. 10 and published
in the Dec. 13 Federal Register [67 FR 76885]. They
state as a general provision, "An entity or individual
may not possess or use in the United States, receive from
outside the United States, or transfer within the United States,
a select agent or toxin unless such activities are conducted
for a lawful purpose and in accordance with the provisions
of [these regulations]."
The Centers for Disease Control and Prevention (CDC), acting
for the Department of Health and Human Services (HHS) at the
behest of the HHS Secretary, developed the interim final rule
regulating the use of designated agents that could be accidentally
or potentially misused against human beings as, for example,
in a terrorist action. A complementary set of rules was issued
by the Department of Agriculture's Animal and Plant Health
Inspection Service (APHIS) regulating the use of designated
agents that could be misused against the nation's food supply
or other resources.
The interim final rules require all entities in the United
States to register possession of these select agents, to designate
a responsible official for overseeing their control, and to
develop plans for safety, security, record keeping, and other
actions in compliance with the rules. The most notable requirement
is for entities possessing such agents to apply for and receive
a "security risk assessment" from the U.S. Attorney
General of the institutions and personnel who use or have
access to select agents. Under these requirements, individuals
who are not permanent U.S. residents and who are nationals
of states officially designated by the U.S. State Department
as supporting international terrorism will not be permitted
access to these laboratories.
The CDC reports that the interim final rule will become effective
on Feb. 7, 2003, and that it will accept public comments on
the rule until Feb. 11. Other important dates - milestones
in implementation of the rule - are reported in the Federal
Register announcement.
A public hearing on the rule was held in Washington, DC,
on Dec. 16. In a cautionary note - and as an example of unintended
consequences - the New York Times reported on Dec. 17 that
many universities and research institutes are destroying existing
stocks of select agents, particularly if such agents are not
essential to their research missions. The newspaper quotes
a representative of the White House Office of Science and
Technology Policy expressing concern that unique strains of
these agents, potentially useful in combating biological terrorism,
may be lost.
Information:
Stephen Heinig, Senior Research Fellow
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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