The purpose of this policy is to ensure that all federally regulated Select Agents and Toxins on University of Pennsylvania campuses are handled safely, secured properly, and registered with the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and/or the United States Department of Agriculture, USDA Animal and Plant Health Inspection Service (APHIS).
The policy describes requirements for the possession, use, receipt or transfer of Select Agents. These requirements are designed to protect against misuse of Select Agents. Possession, use, transfer or disposal of these agents may not occur without approval of the director of the Office of Environmental Health and Radiation Safety (EHRS).
This policy applies to University faculty and staff, students and visitors who receive, possess, use, transfer or acquire Select Agent(s) while participating in any University-sponsored activity on the Philadelphia campus, at New Bolton Center or the Morris Arboretum.
"Select Agent" as defined by the CDC and APHIS, means biological agents or toxins deemed a threat to the public, animal or plant health, or to animal or plant products.
"Biological agent" means any microorganism (including, but not limited to bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occuring bioengineered or synthesized component of any such microorganism or infectious substance, capable of causing death, disease or other biologiclal malfunction in a human, an animal, a plant or another living organism; deterioration of food, water, equipment, supplies or material of any kind; or deleterious alteration of the environment.
"Toxin" means the toxic material or product of plants, animals, microorganisms (including, but not limited to bacteria, viruses, fungi, ricksettsiae or protozoa) or infectious substances, or recombinant or synthesized molecule, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such a substance.
"Access" means the an individual has possession of a select agent or toxin (eg., ability to carry, use, or manipulate) or the ability to gain possession of select agent or toxin. Only authorized persons are permitted access to Select Agents. Access to a Select Agents can be limited by either security containers or by escorts. For non-laboratory functions including routine cleaning, maintenance and repairs, non-approved individuals will be allowed access to areas where Select Agents are accessible only if they are escorted and monitored by an individual who has been approved.
"Authorized person" is an individual who has been approved for access to Select Agents through the successful completion of an FBI security risk assessment.
"Entity" means any government agency (Federal, State or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity. For purposes of this policy, the entity is the University of Pennsylvania.
"Responsible Official" (RO) means the individual designated by the entity to act on its behalf. This individual must have the authority and control to ensure compliance with the regulations. For purposes of this policy, the RO is the director of EHRS, the alternate RO is the Institutional Biosafety Officer.
"Restricted Person" means any individual who:
A. is under indictment for a crime punishable by imprisonment for a term exceeding 1 year;
B. has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
C. is a fugitive from justice;
D. is an unlawful user of any controlled subtance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802));
E. is an alien illegally or unlawfully in the United States;
F. has been adjucated as a mental defective or has been committed to any mental institution;
G. is an alien (other than an alien lawfully admitted for permanent residence) who is a national of Cuba, Iran, Iraq, Libya, North Korea, Sudan or Syria, or any other country to which the Secretary of State, pursuant to applicable law, has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism;or
H. has been discharged from the Armed Services of the United States under dishonorable conditions.
Restricted persons are prohibited from having access to Select Agents.
The director of EHRS is the Responsible Official (RO) for the University of Pennsylvania. All activities involving registration with federal agencies, intramural or extramural transfers, disposal and exclusion or exemption from regulation must be coordinated through EHRS and reviewed and approved by the RO. The RO submits all applications to CDC and/or USDA.
The Institutional Biosafety Officer is the Alternate RO (ARO) for the University of Pennsylvania. The ARO conducts the duties of the RO when the RO is unavailable.
The Principal Investigator (PI) is responsible to direct a project or program involving Select Agents in compliance with all regulatory requirements set forth. The PI is responsible to the University of Pennsylvania for the scientific and technical direction of the project or program.
Authorized persons with access to Select Agents are required to attend special training prior to handling Select Agents and follow prescribed work practices. Authorized persons must handle Select Agents safely, secure them properly when they are not in use, update inventories regularly and dispose of materials appropriately when work is completed.
Restricted persons are prohibited from having access to Select Agents.
4.1 Select Agent Registration
4.1.1. Principal Investigators considering work with Select Agent material subject to the Federal Select Agent Program must contact EHRS to initiate the registration process. PIs must register their intent to use Select Agent materials with the CDC and / or APHIS PRIOR to bringing Select Agent materials to Penn campuses. PIs, in collaboration with EHRS staff, must complete the application packet and submit it to the RO for submission to CDC and / or APHIS.
4.2 Exclusion / Exemption
4.2.1. Certain Select Agent materials that meet regulatory criteria are exempt from registration with the CDC and / or APHIS. A list of exemptions can be found at the bottom of the select agent list. To ensure regulatory compliance, EHRS requires PIs to maintain an inventory logbook to document quantities, use and destruction of exempt Select Agent toxins. Select Agent toxins may not be destroyed until an EHRS Notification of the Proposed Destruction of Select Agents Form (pdf) documenting the method of destruction, has been submitted by the laboratory to EHRS and approved by the RO.
4.2.2. PIs, in collaboration with the RO, may request specific exclusion of materials they do not consider to fall under the regulations. A current list of attenuated strains of select biological agents and toxins that are excluded from the Act can be found at the CDC website. PIs must submit exclusion requests to the RO who will review the request and submit it to CDC and/or APHIS if deemed appropriate. Exclusion requests to CDC or APHIS must be signed by the RO and processed by EHRS. Exclusion requests are evaluated by CDC or APHIS on an individual basis and may be granted if the agency determines the material does not pose a significant public health or safety threat.
4.3 Personnel Security Risk Assessment
Prior to working with or having access to Select Agents all individuals must undergo a security risk assessment (including fingerprinting) by the FBI. Individuals may not have access to select biological agents or toxins unless CDC or APHIS, based on the security risk assessment, approves them for access. This security risk assessment is valid for three (3) years, unless the CDC or APHIS terminate the approval sooner.
Individuals who are considered "restricted persons" may not have access to select biological agents or toxins.
Select Agent training, provided by EHRS either online or in person, is required annually for authorized persons who are allowed access to Select Agents.
Stored Select Agents must be secured in a locked container. The containers must be kept locked at all times. If lock boxes are used they must be affixed to the refrigerator/freezer/cabinet. Lock boxes are available from EHRS. Select Agents not in storage must be controlled and maintained under constant surveillance by an authorized person.
4.6.1. The RO must keep an up-to-date accurate list of all individuals approved for Select Agent access.
4.6.2. The RO must maintain records pertaining to inspections; safety, security and emergency response plans; training; transfer documents and incidents reports.
4.6.3. Principal investigators must maintain a current and accurate Select Agent inventory as described in the relevant regulation.
4.6.4. Principal investigators must maintain a log(s) as described in the relevant regulation to track all persons who enter the area where select agents are used or stored. The log(s) must record the time of entry and enter/exit for (1) all approved users (2) others, along with the name of the approved escort.
4.6.5. All records and logs must be kept for a minimum of 3 years.
4.7.1. Extramural transfers of Select Agents may not occur without prior authorization of the ROs at the facilities of the transferor and recipient.
4.7.2. Intramural transfer of the Select Agents must be approved by the RO before the transfer occurs.
4.8 Destruction and Disposal
Destruction and disposal of Select Agents must be done in accordance with federal procedures. Select Agents may not be destroyed until an EHRS Notification of the Proposed Destruction of Select Agents Form (pdf) documenting the method of destruction, has been submitted by the Select Agent laboratory to EHRS and approved by the RO. The appropriate federal agency must be notified by the RO five (5) working days in advance of destruction of any Select Agent biological agents or toxins.
4.9 Clinical and Diagnostic Laboratories
Directors of Clinical or Diagnostic Laboratories that identify certain biological agents and toxins from diagnostic or verification testing activities are required to contact CDC and / or APHIS immediately. Directors must contact EHRS for further instructions.