Laboratory Services

The University of Mississippi

USA Patriot Act

The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001

Summary:

The USA Patriot Act was signed into law to establish specific requirements for the control and use of biohazardous materials referred to as “select agents”. Among the requirements is the need to identify materials and to eliminate access to these materials for a population of individuals who have been defined by the Act as “Restricted Persons”.

Scope:

This Regulation applies to any research or other operation that currently has in possession, uses, or wishes to transfer or receive a biohazardous material listed by the CDC as a “select agent”.

Reference Regulations:

  • USA PATRIOT ACT of 2001 (Public Law 107-56).
  • Centers for Disease Control and Prevention (42 CFR 72.6) “Additional requirements for facilities transferring or receiving select agents.” Final Rule, Federal Register, Oct. 24, 1996.
  • The Antiterrorism and Effective Death Penalty Act of 1996 (Public Law 104-132).
  • The Controlled Substances Act (21 U.S.C. 802).
  • Immigration and Nationality Act (8 U.S.C. 1101).

Definitions:

Select Agent – A viable biological agent or its toxin, which causes or may cause disease in humans or animals, and includes those agents listed in 42 CFR 72. Select agent does not include any such biological agent or toxin that is in its naturally occurring environment, if the biological agent or toxin has not been cultivated, collected, or otherwise extracted from its natural source.

Restricted Person – An individual 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 (as defined in section 102 of the Controlled Substances Act );
  • 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; or
  • Has been discharged from the Armed Services of the United States under dishonorable conditions.

Alien – Is any person who is not a citizen or a national of the United States. Access – The ability of an individual to gain entry into a space where a select agent is used or stored. Escorted or unescorted conditions are not to be a consideration in this definition, nor are locked or unlocked conditions of the select agent stocks.

Responsibility:

Deans, Directors and Department Heads

  • Notify the Health & Safety Officer in the event the department has in possession, or plans to use, any ‘select agent’ as identified in the most current list maintained by Health & Safety.
  • Assure compliance with requirements of this regulation, as well as follow on direction from Health & Safety or University Police (UPD), in order to meet the safety and security procedures under the Patriot Act.
  • Assist the facility to ensure operations appropriately restrict access.

Principal Investigators with Select Agents in Possession

  • Work with Health & Safety and UPD to implement procedures to maintain the security of Select Agents.
  • Assure that all Select Agent use or possession is registered with the University’s Health & Safety Officer (HSO).
  • Supply to Health & Safety a list of all individuals who may have access to the ‘select agents’ in possession. The purpose of the list is for Health & Safety and UPD to make a determination if any of the individuals meet the criteria of a ‘Restricted Person’.
  • Have each individual who may have access to the ‘select agents’ complete a Patriot Act Restricted Persons Affidavit and submit the form(s) to the University Police Department.
  • Immediately notify DHS of any new individuals who may have access to the ‘select agents’ in order to make sure they meet the security requirements. This notification must be made, and security approved, prior to granting any access to the agents.

Health & Safety

  • Maintain a University-wide registration for ‘select agent’ transfer and use.
  • Assist UPD in performing a safety and security investigation of all areas where ‘select agents’ may be used or stored.
  • Maintain a list of all approved individuals who may have access to ‘select agents’ on University property.
  • Assist departments in meeting requirements of the Act regarding the transfer of ‘select agents’ both internal and external to the University.
  • Monitor new legislation to assure timely incorporation of safety and security requirements that may impact the use of ‘select agents’ and make appropriate notification to laboratory personnel.
  • Provide periodic monitoring of areas where ‘select agents’ may be used or stored to assure continuing compliance with this regulation.

University Police Department (UPD)

  • Act as the point of contact for all law enforcement agencies and investigations.
  • Provide a security background check of all individuals identified who may have access to ‘select agents’ on campus.
  • Maintain a secure storage for records pertaining to background checks and Patriot Act Restricted Persons Affidavits provided by the departments.
  • Based on the background investigations and the Patriot Act Restricted Persons Affidavits, make a determination regarding the ‘Restricted Person’ status of individuals requesting access to ‘select agents’.
  • Assist Health & Safety in performing a safety and security investigation of all areas where ‘select agents’ may be used or stored.
  • Provide periodic monitoring of areas where ‘select agents’ may be used or stored to assure continuing compliance with this regulation.

Procedures:

Restricted Person Determination Procedure

This procedure will be used to make a determination on the status of individuals who may access select agents with regards to the ‘Restricted Person’ status under the Patriot Act.

  • The Department or Principal Investigator (PI) planning to use a Select Agent will notify the University Health & Safety Officer (HSO) at 5433 to begin the process of identifying safety and security requirements. The PI and HSO will determine who will have access to the ‘select agent’ in order to determine the ‘Restricted Person’ status.
  • The HSO will provide the list of persons to UPD and work with UPD to schedule a site visit to determine what safety and security measures will be required.
  • UPD will perform the background investigation as follows:
    • UPD will send a copy of this guideline and the Patriot Act Restricted Persons Affidavit to each individual identified by the PI.
    • Once the individual returns the affidavit to UPD, an interview will be scheduled to begin the background investigation.
    • UPD will ask the individual to sign the Patriot Act Authorization for Release of Information and will obtain information necessary to perform the investigation.
    • UPD will conduct a background investigation consisting of the following elements:
      • A check of any criminal history of the applicant, as well as outstanding wants or warrants, via the Law Enforcement Information Network.
      • Contact with the Immigration and Naturalization Service and the U.S. Department of State regarding visa status and any relevant information concerning the applicant, including country of origin.
      • A check of any U.S. military service record and status of any discharge from that service.
      • An interview of the applicant will further review his/her suitability for access to ‘select agents’.
  • Upon completion of the background investigation, a recommendation will be made as to the individual’s ‘Restricted Person’ status for access to ‘select agents’. A copy of the determination will be provided to the individual, the Department, DHS, as well as be maintained by UPD.
  • All documents compiled as part of the background investigation will be stored in the University Police Department. Those documents will be held in a secure cabinet dedicated to only those files, and will be accessible only to the Records Manager and the Chief of the Police Department. The records will be released only under authority of law or under court order.
  • Once the determination is complete, the PI is responsible to ensure that only individuals who have been determined to not be a Restricted Person under the Patriot Act have access to the ‘select agents’. Any new individuals being added to the laboratory staff must go through the background investigation before they can begin work in areas accessible to the agents.