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:

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.

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.

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

Rickettsiae
1. Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii

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


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