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MSU USA PATRIOT ACT FREQUENTLY ASKED QUESTIONS
What
is the USA PATRIOT Act and how does it affect research laboratories?
In recent years,
the threat of illegitimate use of infectious agents has attracted
increasing interest from the perspective of public health, in view
of concern that certain biological agents and toxins could have
serious adverse consequences for human health and safety. The USA
PATRIOT Act is a law signed by President Bush that went into effect
on October 26, 2001. The full name of the act is the Uniting and
Strengthening America by Providing Appropriate Tools Required to
Intercept and Obstruct Terrorism Act of 2001. Among other things,
the law makes it unlawful for restricted persons to have access
to certain biological agents and toxins, known as 'select agents'.
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Who
is a 'restricted person' under the USA PATRIOT Act?
A restricted
individual under this law is anyone who:
- is under
indictment for a crime punishable by imprisonment for a term exceeding
1 year;
- has been
convicted in any court of a crime punishable by imprisonment for
a term exceeding 1 year;
- is a fugitive
from justice;
- is an unlawful
user of any controlled substance;
- is an alien
illegally or unlawfully in the United States;
- has been
adjudicated as a mental defective or has been committed to any
mental institution;
- is an alien
(other than an alien lawfully admitted for permanent residence)
who is a national of a country as to which the Secretary of State
has made a determination (that remains in effect) that such country
has repeatedly provided support for acts of international terrorism.
As of October 2001, these countries were Iran, Iraq, Syria, Libya,
Cuba, North Korea, and the Sudan;
- has been
discharged from the Armed Services of the United States under
dishonorable conditions.
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What
are the 'select agents' under the USA PATRIOT Act?
As of October
2002, the list of 'select agents' as determined by the Centers for
Disease Control (CDC) and found at 42 CFR 72 included:
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Viruses
1.
Crimean-Congo haemorrhagic fever virus
2. Eastern equine encephalitis virus
3. Ebola virus
4. Equine morbillivirus
5. Lassa fever virus
6. Marburg virus
7. Rift Valley fever virus
8. South American haemorrhagic fever viruses (Junin, Machupo,
Sabia, Flexal, and Guanarito)
9. Tick-borne encephalitis complex viruses
10. Variola major virus (Smallpox virus)
11. Venezuelan equine encephalitis virus
12. Viruses causing hantavirus pulmonary syndrome
13. Yellow fever virus
Exemptions:
Vaccine strains of these viral agents as described in the
fourth edition of the CDC/NIH ''Biosafety in Microbiological
and Biomedical Laboratories'' are exempt.
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Bacteria
1.
Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Burkholderia (Pseudomonas) mallei
4. Burkholderia (Pseudomonas) pseudomallei
5. Clostridium botulinum
6. Francisella tularensis
7. Yerinia pestis
Exemptions:
Toxins for medical use, inactivated for use as vaccines, or
toxin preparations for biomedical research use at an LD50
for vertebrates of more than 100 nanograms per kilogram body
weight (e.g., micro-bial toxins such as the botulinum toxins,
tetanus toxin, diphtheria toxin, and Shigella dysenteriae
neurotoxin) are exempt.
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Toxins
1. Abrin
2. Aflatoxins
3. Botulinum toxins
4. Clostridium perfringens epsilon toxin
5. Conotoxins
6. Diacetoxyscirpenol
7. Staphylococcal enterotoxins
8. Ricin
9. Saxitoxin
10. Shigatoxin
11. Tetrodotoxin
12. T-2 toxin |
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Rickettsiae
1.
Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii
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Fungi
1. Coccidioides immitis |
Recombinant
organisms/molecules
1. Genetically modified microorganisms or genetic elements from
agents in these lists that have the potential to encode for
a factor associated with disease.
2. Genetically modified microorganisms or genetic elements that
contain nucleic acid sequences coding for any of the toxins
on these lists, or their toxic subunits. |
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How
does the University monitor where select agents are used on campus?
Working with
Department Chairs and Principal Investigators (PI's), the University
Biological Safety Officer (BSO) and the Office of Radiation, Chemical
and Biological Safety (ORCBS) have identified campus facilities
that use these agents and toxins, and the individuals within the
laboratories that have access to them. ORCBS maintains a select
agent user database and updates this database to include prospective
users by undertaking periodic surveys. Individuals, including PI's,
desiring access to select agents are required to successfully complete
an MSU USA PATRIOT Act Checklist of Eligibility. Applicants meeting
the requirements of the USA PATRIOT Act will be granted approval
by the Vice President for Research and Graduate Studies (VPRGS)
or his designee. USA PATRIOT Act Checklists are available from MSU's
BSO and can be viewed at www.biosafety.msu.edu.
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How
does the checklist/registration process work?
The PI is responsible
to ensure that only individuals who have been determined not to
be 'restricted persons' have access to any select agent in the PI's
laboratory/facility. Prior to using or seeking to obtain or transfer
a select agent, the Principle Investigator must notify and deliver
to the BSO a list of all persons with access to the select agent.
From the lists of individuals submitted by PI's, the BSO compiles
and maintains a list of all persons with access to select agents
on University property. The PI provides each individual with access
to the select agent a USA PATRIOT Act Restricted Person Checklist.
Each such individual, including the PI, completes the Checklist
and returns it to the PI for submission to the VPRGS. The VPRGS
(or his designee) compiles and maintains a list of all individuals
who have submitted a completed USA PATRIOT Act Restricted Person
Checklist. The BSO obtains from the VPRGS (or his designee) the
list of all individuals who have submitted a completed USA PATRIOT
Act Restricted Person Checklist and who are eligible for select
agent access.
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What
security measures are laboratories in possession of select agents
required to employ?
In addition
to identifying all individuals with access to a select agent and
registering these individuals with the Biological Safety Officer,
labs working with a select agent are required to consult with the
Department of Police and Public Safety and ORCBS to develop and
implement appropriate security measures. At a minimum, the lab or
facility must adopt the following security measures:
- Control access
to the area with card-keys or other similar devices where select
agents are used and stored.
- Restrict
access to select agents to allow only those workers who are authorized
and required to perform work in the area.
- Limit the
access of non-laboratory personnel.
- Keep the
room locked at all times.
- Record all
entries to the laboratory, including entries by visitors, maintenance
workers, repairpersons and others needing one-time or occasional
entry.
- Freezers,
refrigerators, cabinets, and other containers where stocks of
select agents are stored should be locked at all times.
- Screen all
packages being removed from or brought into the laboratory or
facility.
- Have an emergency
plan in place in case of an emergency.
- Report incidents
to the appropriate department, administrators, or agencies.
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Where
can I obtain more information regarding the USA PATRIOT Act and
how it applies to Michigan State University?
Please contact
the Office of Environmental Safety at (517) 353-1768 or the Biological
Safety Officer at (517) 353-1877. Additional resources can be found
at:
www.cdc.gov/od/ohs/lrsat.htm
www.cdc.gov/od/ohs/biosfty/imprtper.htm
www.biosafety.msu.edu
Select
Agents Home
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