Biomedical Engineering Reference
In-Depth Information
TABLE 18.1
HHS, USDA, and Overlap Select Agents d cont'd
OVERLAP
Bacteria
Viruses
Bacillus anthracis
Hendra virus
Brucella abortus
Nipah virus
Brucella melitensis
Rift Valley fever virus
Brucella suis
Venezuelan equine encephalitis virus
Burkholderia mallei
Burkholderia pseudomallei
Certain agents are excluded from the select agent list,
including those that are in their naturally occurring envi-
ronments, nonviable agents or nonfunctional toxins, certain
vaccine strains, and attenuated agents or toxins approved by
the CDC. HHS-controlled toxins are not regulated if the
total amount held at any given time does not exceed
specific, established limits.
The Intragovernmental Select Agents and Toxins
Technical Advisory Committee (ISATTAC) reviews
requests for the addition or deletion of agents or toxins
from the select agents list, for exclusion of attenuated
strains, and for permission to conduct restricted experi-
ments. The ISATTAC makes recommendations to the CDC
DSAT. The select agent list is assessed by the CDC and
APHIS every two years, though adjustments may be made
sooner if deemed necessary, as in the case of the addition of
the reconstituted 1918 influenza virus after the coding
sequence and results of successful reconstruction were
published.
The National Select Agent Registry (NSAR) is
a collaborative effort between the CDC and APHIS as
a central location where pertinent select agent regulations,
guidelines, and forms can be accessed ( www.selectagents.
gov ).
Entity Registration and Security Risk
Assessments
Before an entity (defined as any government agency,
academic institution, corporation, company, partnership,
society, association, firm, sole proprietorship, or other legal
entity) is permitted to work with select agents, in a labora-
tory or in animal facilities, it must first submit an application
(APHIS/CDC Form 1) to APHIS or CDC. An entity's
responsible official (RO) is an individual designated by an
entity to act on its behalf and ensures compliance with
regulations. An alternate responsible official (ARO) may be
designated by the entity to act in place of the RO. The DOJ
Criminal Justice Information Services Division (CJIS)
conducts security risk assessments on individuals and enti-
ties requesting select agent access and identifies those pro-
hibited from access based on restrictions identified in the
USA PATRIOT Act. CDC and APHIS use this information
to authorize or deny access to select agents and toxins. The
application for security risk assessment can be found in FBI
form FD-961 and must be sent directly to the CJIS, not to the
lead agency. An individual security risk assessment is valid
for 5 years. An entity's certificate of registration is valid for
3 years, and the associated RO, ARO, and individuals that
own or control the entity must have security risk assess-
ments conducted at each registration renewal. Institutions
working with select biological agents and toxins face
temporary or permanent cessation of associated research
activities and large monetary fines if select agent regulations
are not strictly adhered to. Individuals involved may also be
held liable with both civil and criminal penalties, including
imprisonment for up to 5 years for each violation.
CDC Category A, B, and C Bioterrorism Agents/
Diseases
The CDC separates potential bioterrorism agents into three
categories; this categorization is independent of select
agent status. Category A agents are defined as those that are
readily transmitted person-to-person and cause high
mortality with the potential to cause a major impact on
public health, likely inducing panic and social disruption.
Category B agents are less easily disseminated and result in
only moderate morbidity and low mortality. Readily
available emerging pathogens with the potential for high
morbidity and mortality rates are grouped in Category C.
Table 18.2 lists current CDC Category A, B, and C agents/
diseases.
Theft, Loss, and Release
The following definitions are used for reporting purposes.
Theft e unauthorized removal of select agent or toxin from
an approved facility. Loss e failure to account for select
agent or toxin. Release e release of select agent or toxin
outside of the primary containment barrier. The laboratory
room may be considered a primary containment barrier if
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