AAMC Letter to CDC on Select
Agents Interim Final Rule
February 3, 2003
Select Agent Program
Centers for Disease Control and Prevention
1600 Clifton Road, E-79
Atlanta, GA 30333
By email: SAPcomments@cdc.gov
Re: Possession, Use, and Transfer of Select Agents and
Toxins: Interim Final Rule (67 FR 76886-900)
The Association of American Medical Colleges (AAMC) appreciates
the opportunity to comment on the interim final rule regulating
the possession, use, and transfer of biological select agents
under 42 CFR Part 73.
The AAMC represents all 125 allopathic U.S. medical schools,
some 400 teaching hospitals, 94 medical professional societies
with approximately 88,000 faculty members, and the nation's
67,000 medical students and 103,000 residents. Our member
institutions include leading centers for microbiological and
other biomedical research and will play an increasingly important
role in strengthening the nation's public health security.
Moreover, these institutions and their personnel may find
themselves among the responders in the event of a public health
emergency. Consequently, the AAMC strongly supports efforts
to promote the security and safety of research using select
agents.
The AAMC fully endorses the recommendations and comments
submitted by the Howard Hughes Medical Institute (HHMI) ,
which were compiled in consultation with environmental and
safety officers at leading academic institutions. We urge
the Department of Health and Human Services (DHHS) to adopt
all of the HHMI proposed revisions, which seek a more consistently
performance-based implementation of safety and security procedures
in the final rule. We underscore several of these recommendations
here for emphasis.
Our chief concern is that the final rule should make explicit
the necessary requirements for our institutions to submit
and complete successfully a Security Risk Assessment (Section
73.8) from the Department of Justice. Otherwise, we must concur
with HHMI that the process outlined in the interim final rule
potentially could confound and thwart the DHHS's responsibility
to ensure that biological agents and toxins are appropriately
available for research, education, and other legitimate purposes
as required by the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. The Department's elucidation
of these requirements should rely on extensive input from
academic institutions, which are currently subject to various
state and other regulations and policies restricting the disclosure
of personal information about faculty, staff, and students.
The final rule should also provide a process for a subject
individual or entity to appeal an adverse security determination.
The rule's Security provisions (Section 73.11) should be
modified to permit institutions to develop or adapt procedures
commensurate with the level of risk posed by each agent, which
Congress intended, and which would promote a more performance-based
strategy for compliance, consistent with the approach engendered
by the rule's Safety provisions (Section 73.10). Again, the
AAMC is principally concerned to see that effective security
procedures are implemented in a manner that permits continuation
of important microbiological, immunological, and related health
research. The HHMI's thoughtful and detailed recommendations
for revising the security provisions would help ensure this
approach.
In other recommendations:
We are uncertain why Cercopithecine herpesvirus 1 was
included in the select agents list (Section 73.4), based
on reports of its limited risk of transmission to humans
and absence of convincing evidence of spread in aerosols.
Macaques, which are the natural host of this virus, are
widely used in research and the husbanding and management
of this resource-already subject to intensive regulation
and guidance-should not be unduly burdened.
Under registration requirements (Section 73.7), we recommend
deleting the provision (2)(viii) requiring entities to submit,
in addition to the specified list of information items,
"Any other information necessary for the determination."
This language is vague, boundless, and uninformative. The
section makes clear elsewhere that the grant of a certificate
of registration may be contingent on submission of other
specified information.
We strongly support HHMI's recommendations that DHHS and
USDA create a single office for receiving registrations
for the possession, use, and transfer of select agents and
toxins under their respective regulations (Section 73.7
(c)), to permit a single registration to cover all subject
activities on a university campus (Section 73.7(f)), and
to validate a certificate of registration for up to five
years (Section 73.7(g)).
The AAMC agrees with the Department's observation in the
discussion section that many of the rule's provisions codify
procedures already developed and set in place by many academic
and other institutions conducting research on select agents
and toxins. This testifies to the commitment and professional
responsibility of academic institutions in accomplishing their
research, educational, and public health missions. Recognizing
the importance of implementing comprehensive safety and security
regulations for select agents and toxins that are workable
and effective, and that will not inhibit essential research,
the AAMC urges continued and open dialogue between the Federal
Government and academic scientists and institutions on these
matters.
Sincerely,
[Signed]
Jordan J. Cohen, M.D.
President Association of American Medical Colleges
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