AAMC Comments on Select Agents
Rule
February 14, 2003 - Federal regulations governing
possession and use of biological "select agents"
went into effect Feb. 7. The regulations, in the form of an
interim final rule published by the Department of Health and
Human Services on Dec. 13, 2002, and a companion rule published
by the U.S. Department of Agriculture, establish requirements
for the safety and security of research involving specified
pathogens and toxins, pursuant to anti-terrorism legislation
signed by President Bush last June. The Centers for Disease
Control and Prevention (CDC), which led the DHHS effort developing
the rule, invited public comments for a two-month period ending
Feb. 11.
In its comment letter, the AAMC commended the CDC for adopting
a performance-based approach for institutions complying with
the rule and argued for a more consistent application of this
approach in the rule's security provisions. In particular,
the AAMC was troubled that the interim final rule does not
sufficiently specify the procedures and process for obtaining
a required "security risk assessment" from the U.S.
Attorney General, although the first of a series of deadlines
for applying for these assessments ends March 12, 2003. The
AAMC's comments endorsed a comprehensive and detailed set
of recommendations developed by the Howard Hughes Medical
Institute (HHMI) in collaboration with safety officers from
leading academic institutions. The AAMC and HHMI urged the
government to consolidate the CDC and USDA offices that process
select agent registrations.
Researchers should be reminded that the federal government
has created a temporary repository for select agents that
might otherwise be destroyed by institutions or investigators
discontinuing their research on these substances. Interested
persons should contact the CDC's Bioterrorism Preparedness
and Response Program.
Information:
Stephen Heinig, Senior Research Fellow
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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