STANFORD UNIVERSITY

OFFICE OF THE GENERAL COUNSEL

 

Main Telephone (650) 723-9611                                                                                         Writer’s Direct Dial (650) 725-9560

Facsimile (650) 723-4323                                                                                                                                LKS@stanford.edu

              http://www.stanford.edu/dept/legal/            

 

November 21, 2002

 

RE:       RECENT BIOTERRORISM LEGISLATION

 

Dear Colleague:

 

Recently, the legal office has received a request to educate the Stanford biology community about newly enacted bio-terrorism legislation and its application to the University.  Following the events of September 11th 2001, Congress considered a spate of legislation to combat terrorism.  Two of these pieces of legislation have been enacted into law and deserve some discussion:  The USA Patriot Act of 2001 and The Public Health Security and Bioterrorism Preparedness and Response Act of 2002.   Both of these laws restrict access to certain biological agents and toxins. 

 

The Patriot Act

http://www.asmusa.org/hr3162sec817.htm

 

The USA Patriot Act was enacted in October of 2001.  Section 817 of the Act creates two new criminal offenses relating to the possession of biological agents and toxins.  First, the Act prohibits the knowing possession of any “biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose.”  The statute expressly exempts agents and toxins in their naturally occurring environment that have not been “cultivated, collected or otherwise extracted from their natural source.”  Violation of this statute imposes a maximum imprisonment term of ten years.

 

 Next, the USA Patriot Act provides that certain “Restricted Persons” may not possess or access certain biological agents and toxins designated by the government as “Select Agents.”  (A list of the Select Agents is attached to this letter.[1])  The Patriot Act provides harsh criminal penalties – again up to ten years imprisonment – to “whoever knowingly violates” the prohibition against access by Restricted Persons.  Congress has


defined a “Restricted Person” to include any individual who falls into one or more of the following categories:

 

1)      A person under indictment for a crime punishable by imprisonment for a term exceeding one (1) year, i.e. a felony;

 

2)      A person convicted in any court of a crime punishable by imprisonment for a term exceeding one (1) year, i.e. a felony;

 

3)      A fugitive from justice;

 

4)      An unlawful user of controlled substances, i.e. a user of illegal drugs or prescription drugs without a valid prescription;

 

5)      An illegal alien;

 

6)      A person adjudicated as a mental defective or a person who has been committed to any mental institution;

 

7)      An alien-national (other than an alien lawfully admitted for permanent residence to the United States) of CUBA, IRAN, IRAQ, LIBYA, NORTH KOREA, SUDAN, or SYRIA; or

 

8)      A person discharged from the Armed Services of the United States under dishonorable conditions.

 

 

The Public Health Security and Bioterrorism Preparedness and Response Act   http://energycommerce.house.gov/107/pubs/H3448_CON.pdf

(Beginning at section 201, page 113)

 

            The Public Health Security and Bioterrorism Preparedness and Response Act (“Response Act”) became effective in June 2002.  Section 351 of the Act expands the reach of the USA Patriot Act in regulating the possession and transfer of Select Agents.  Specifically, the Act requires the Department of Health and Human Services and the Department of Agriculture to:  1) implement registration procedures for all Select Agents, and 2) establish and enforce safety and training procedures governing the possession of Select Agents.  The Act requires that the agencies develop a database identifying all facilities with access to Select Agents.  (These databases are exempted from the Freedom of Information Act and will not be publicly available.)  In addition, the agencies must ensure that all facilities limit access of Select Agents to “only those individuals the registered [facility] determines have a legitimate need to handle or use” them.  The agencies are authorized to conduct inspections to ensure compliance with the Response Act and its accompanying regulations.

 

Background Check by Attorney General[2]

 

The Response Act also requires that each facility provide identifying information of the personnel with access to Select Agents, which is then forwarded to the Attorney General to conduct a background review.  Using criminal, immigration, national security “and other electronic databases that are available to the Federal Government and are appropriate”, the background check includes a determination as to whether the individual is: 1) a Restricted Person (as defined by the USA Patriot Act); 2) reasonably suspected of committing a violent or terrorist act; 3) known to engage in an organization that engages in domestic or international terrorism or intentional crimes of violence; or 4) an agent of a foreign power. 

 

The Attorney General will promptly notify the agency of any individual that does not pass the background check.  The Response Act provides for administrative review of the decision to deny or revoke access of Select Agents to any individual or facility.  

 

Criminal Penalties

 

The Response Act provides for up to five years imprisonment to every person who transfers a Select Agent to an individual or facility “who the transferor knows or has reasonable cause to believe is not registered” under the Act.  The Response Act also imposes up to five years imprisonment to every person who possesses a Select Agent without proper registration.

 

COMPLIANCE

 

Stanford has made substantial efforts to ensure its compliance with both of these new laws.  Earlier this year, Stanford sent out a letter explaining the USA Patriot Act to every individual at the University currently in possession of a Select Agent.  If today’s letter raises new concerns to anyone with access to a Select Agent that you may be a Restricted Person under the USA Patriot Act, you must contact Dr. Krueger, charles.kruger@stanford.edu.  The University will make every appropriate effort to work with Restricted Persons to find a research alternative that does not necessitate the use of a Select Agent.

 

Earlier this summer the Office of Environmental Health & Safety (EH&S) developed an internal secure database to track biological agents present at the University in accord with a directive from the BioSafety Panel.  From this database, EH&S was able to register the Select Agents present at the University in compliance with the Response Act.  To the extent that you completed the EH&S web survey completely and accurately, then you are in compliance with the registration portion of the Response Act.  If you have any concerns regarding registration, please contact Dr. Segal of EH&S, esegal@stanford.edu.

 

If you have any other questions or would like more information, please do not hesitate to contact me.

 

 

 

                                                            Very truly yours,

 

                                                            /s/

 

                                                            Lauren K. Schoenthaler

                                                            University Counsel

 

 

 

                                                           

 

 

Select Agents

 

                                 Viruses

 

1. Crimean-Congo haemorrhagic fever virus

2. Eastern Equine Encephalitis virus

3. Ebola viruses

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, 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 viral agents (Junin Virus strain candid

#1, Rift Valley fever virus strain MP-12, Venezuelan Equine encephalitis

virus strain TC-83, Yellow fever virus strain 17-D) 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. Yersinia pestis

Exemptions: vaccine strains as described in Title 9 CFR, 78.1 are

exempt.

 

                               Rickettsiae

 

1. Coxiella burnetii

2. Rickettsia prowazekii

3. Rickettsia rickettsii

 

                                  Fungi

 

1. Coccidioides immitis

 

                               


 Toxins

 

1. Abrin

2. Aflatoxins

3. Botulinum toxins

4. Clostridium perfringens epsilon toxin

5. Conotoxins

6. Diacetoxyscirpenol

7. Ricin

8. Saxitoxin

9. Shigatoxin

10. Staphylococcal enterotoxins

11. Tetrodotoxin

12. T-2 toxin

Exemptions: Toxins for medical use, inactivated for use as vaccines, or

toxin preparations for biomedical research use.

 

 

 

 


[1] The list of Select Agents is subject to change.  A new list is expected to be promulgated by the CDC in December 2002.

[2] As of the date of this letter, HHS has not yet implemented this Background Check.