45.20 - Select Agents and Toxins
June 30, 2010
PREAMBLE: This section outlines the legal requirements and procedures required for the possession, use, and transfer of Select Agents and Toxins.
A. Introduction. In the performance of scientific research, when the University of Idaho (UI) uses select agents and toxins (as defined by 42 CFR 73) and biological agents and toxins (as defined in 7 CFR 331 and 9 CFR 121), it is the policy of UI to ensure that receiving, storing, using, transferring, shipping, and disposing of these materials are performed in compliance with all applicable federal and state regulations.
The purpose of 42 CFR 73, 7 CFR 331, and 9 CFR 121 is to provide protection for the misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States. The listed select agents and toxins are those that have the potential to pose a severe threat to public health and safety (42 CFR 73). The listed biological agents or toxins have the potential to pose a severe threat to plant health or plant products (7 CFR 331) or the potential to pose a severe threat to both human and animal health, or to animal health or animal products (9 CFR 121).
This document is intended to be used as general guidance regarding the possession, use, and transfer of select agents at UI. The regulations may contain additional requirements. Please be sure to contact the UI Biological Safety Officer or the Office of Research Assurances (ORA) with specific questions or concerns.
A current list of Select Agents and Toxins can be found at the National Select Agent Registry (NSAR) website.
B. Legal Authority. On April 15, 1997 "The Antiterrorism and Effective Death Penalty Act of 1996" (Section 511 of Public Law 104-132) became effective. This law was enacted due to the threat of the illegitimate use of infectious agents and the potential serious adverse consequences for human health and safety. In response to this legislation the Department of Health and Human Services (HHS) published the Select Agents Rule (42 CFR 72, "Additional Requirements for Facilities Transferring or Receiving Select Agents"), which became effective on April 15, 1997. This rule created a framework to track the access, use, and transfer of select agents. HHS (CDC) issued a final rule (73 FR 3873) in 2008 that rescinded 42 CFR 72 and replaced these requirements for the handling of select biological agents and toxins with the set of regulations found at 42 CFR 73.
On October 26, 2001 the "United and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism of 2001" Act (USA PATRIOT ACT) was signed into law. The law criminalized the possession of select agents that had no legitimate purpose, banned the possession of select agents by "restricted persons," and required the Secretary of HHS to establish additional standards and procedures to govern the possession, use, and transfer of select agents.
In order to strengthen and enhance the USA PATRIOT ACT of 2001, the "Public Health Security and Bioterrorism Preparedness Act of 2002" (Public Law 107-188) was signed into law on June 12, 2002. This law required that the United States improve its ability to prevent, prepare for, and respond to bioterrorism and other public health emergencies. It mandates that individuals possessing, using, or transferring agents or toxins deemed a threat to public, animal or plant health, or to animal or plant products, notify either the Secretary of the Department of Health and Human Services (HHS) or the Secretary of the Department of Agriculture (USDA).
In order to meet the requirements of the "Public Health Security and Bioterrorism Preparedness Act of 2002," the HHS authorized the Centers for Disease Control (CDC) to develop and administer rules governing the possession, use, and transfer select agents and toxins and the USDA authorized the Animal and Plant Health Inspection Service (APHIS) to develop and administer rules governing the possession, use, and transfer biological agents and toxins. Because there are some agents and toxins common to both lists (termed "overlap agents and toxins") the CDC and APHIS coordinated their efforts while producing three new rules. The CDC (for HHS) introduced 42 CFR 73 ("Possession, Use, and Transfer of Select Agents and Toxins"). The APHIS introduced 7 CFR 331 and 9 CFR 121 ("Possession, Use, and Transfer of Biological Agents and Toxins"). The effective date for these final rules was April 18, 2005, with an effective date of March 10, 2005 for amendments to PPQ select agents and toxins listed at 7 CFR 331.3 (b).
C. Scope. All laboratories and other facilities at UI possessing, using, and transferring select agents and toxins must be registered with the Centers for Disease Control (CDC) or the Animal and Plant Health Inspection Service (APHIS) and shall comply with the requirements set forth in this policy. Registration at UI will be managed through the Office of Research and Economic Development (ORED).
There are partial exemptions found in the regulations regarding certain materials, quantities, uses, programs, and agricultural emergencies. Please be sure to contact the UI Biological Safety Officer (BSO) or ORA with specific questions or concerns. Clinical or diagnostic laboratories that isolate select agents and/or toxins are exempt, provided that the identification of select agents and/or toxins is immediately reported to the APHIS and/or CDC and within seven (7) days such agents and/or toxins are transferred or inactivated (APHIS/CDC Form 4 must be submitted). Some Select Agents and Toxins require notification within twenty-four (24) hours. The list may be found on the NSAR website at www.selectagents.gov. The same exemption applies to proficiency testing, however the reporting period is increased to ninety (90) days (APHIS/CDC Form 4 must be submitted).
D-1. Biological Agent – Any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological 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.
D-2. APHIS/CDC Form 2-"Request to Transfer Select Agents & Toxins" – CDC/APHIS form which documents interfacility transfers of select/overlap agents and toxins as described in 7 CFR 331.16, 9 CFR 121.16 & 42 CFR 73.16.
D-3. Entity – Any government agency (federal, state, or local), academic institution, corporation, company, partnership, society, association, firm sole proprietorship, or other legal entity. Entity for the purpose of this policy is the geographical and organizational confines of UI.
D-4. Memorandum of Understanding and Agreement (MUA) – The University of Idaho document submitted to the Institutional Biosafety Committee (IBC) (see FSH 1640.14) for review of a proposed research project.
D-5. Overlap Select Agent or Toxin – Biological agents or toxins that are found on both the CDC select agent/toxin list and the APHIS biological agent/toxin list.
D-6. Recipient – Any individual who receives or seeks to receive through any means a select agent or toxin from any other person or institution.
D-7. Responsible Official (RO) – The individual designated by an entity to act on its behalf. This individual must have the authority and control to ensure compliance with the regulations 42 CFR 73; 7 CFR Part 331; and 9 CFR Part 121. The RO for UI is the Vice Provost for Research and Economic Development. The Alternate RO’s (ARO’s) are the Associate Vice Provost for Research/Chief Technology Transfer Officer and the Chief Research Compliance Officer.
D-8. Select Agent – The viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic acids, and recombinant organisms listed in 42 CFR 73, 7 CFR 331 & 9 CFR 121. The term also includes:
Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms:
a. Nucleic acids that can produce infectious forms of any of the select agent viruses listed in either CFR part 331 or 9CFR part 121;
b. Recombinant nucleic acids that encode for the functional form(s) of any of the select agent toxins listed in either 7 CFR part 331 or 9 CFR part 121 if the nucleic acids:
i) Can be expressed in vivo or in vitro; or
ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro; and
c. Listed select agents and toxins that have been genetically modified.
D-9. Toxin – The toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substances, or a 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.
D-10. Sender – Any person who transfers or seeks to transfer through any means a select agent or toxin to any other person or institution.
E. Procedures: All laboratories at UI possessing, using, and transferring select agents and toxins will comply with the requirements set forth in this policy and all applicable federal, state, and local regulations. The Office of Research and Economic Development (ORED) maintains the UI select agents and toxins registration granted by the CDC or APHIS and associated program files and records.
E-1. Registration. In order for any laboratory at UI to work with select agents or toxins the laboratory must be registered with the CDC or APHIS.
The registration application for select agents or toxins is APHIS/CDC Form 1. A certificate of registration will be valid only for the specific select agents and toxins and the specific activities and locations specified in the registration application or amendment to the registration application. Registration will be valid for up to three (3) years.
Registration of laboratories at UI will be coordinated through ORED and the UI Institutional Biosafety Committee (IBC) see FSH 1640.14. The ORED will maintain the files of all registration applications and materials.
E-2. Security Risk Assessment (SRA). No individual at UI may possess, use, or transfer any select agent or toxin unless approved by the Health and Human Services (HHS) Secretary or United States Department of Agriculture (USDA) Secretary based upon a security risk assessment by the Attorney General (Department of Justice, DOJ). The security risk assessment is completed when the registration application (or registration application amendment) is submitted to the CDC or APHIS. The registration application (or registration application amendment) must submit the identifying information for all individuals that are expected to work with select agents or toxins at UI. Individuals may not work with select/biological agents until approved by the Attorney General (DOJ).
Access approval is granted for a five (5) year period.
E-3. Responsible Official (RO). In order for any research with select agents or toxins to be conducted at UI an individual must be identified and authorized as the Responsible Official (RO). The RO for UI is the Vice President of Research and Economic Development. Alternate ROs for UI are the Associate Vice President of Research and the Chief Research Compliance Officer, (also known as the Manager of the Office of Research Assurances).
The RO is responsible for ensuring that all UI researchers utilizing select agents or toxins are in compliance with the regulations. Specific responsibilities of the RO include:
a) Developing and implementing safety, security, and emergency response plans.
b) Allowing only approved individuals to have access to select agents or toxins.
c) Providing appropriate training in containment and security procedures for all personnel.
d) Transferring select agents or toxins only to or from registered individuals and with the UI RO’s signature authorizing the transfer (and CDC/APHIS approval).
e) Providing timely notice of any theft, loss, or release of any select agents or toxins.
f) Maintaining detailed records of information necessary to give a complete accounting of all of the activities related to select agents or toxins.
g) Ensuring that annual inspections are conducted for each laboratory where select agents are stored or used.
h) Reporting the identification and final disposition of any select agent or toxin contained in any specimen presented for diagnosis, verification, or proficiency testing.
E-4. Biosafety (see also APM 35.11). Each lab where select agents are used must have a written Biosafety Plan available to identify the specific work practices, containment and safety equipment, and facility design features appropriate for minimizing risks of accidental infection or injury and to prevent contamination of the environment outside the laboratory. This plan must also specifically address the hazards associated with the agents and agent manipulations. It is the responsibility of the principal investigator to develop this plan. All individuals assigned to work with a select agent should review and understand the information contained within the Biosafety Plan prior to their assignment and at least annually thereafter. This plan must be reviewed and approved by the IBC prior to receipt or use of a select agent or toxin.
As a minimum, Biosafety plans should meet or exceed the following guidelines or requirements:
- CDC’s "Biosafety in Microbiological and Biomedical Laboratories" (BMBL) for viable agents,
- OSHA’s Lab Standard – Chemical Hygiene Plan and CDC’s BMBL appendix for toxins,
- NIH’s Guidelines for Research Involving Recombinant DNA Molecules.
For toxins, a Standard Operating Procedure (SOP) for Particularly Hazardous Materials, which is part of an up-dated Chemical Hygiene Plan, is required to supplement the Biosafety Plan information. Generic SOP templates for biological toxins are available from the BSO.
In addition, certain experiments may not be conducted unless also approved by the Health and Human Services (HHS) Secretary. These include:
- Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents or toxins that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
- Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of select/biological toxins lethal for vertebrates at an LD50<100ng/kg body weight.
At the direction of the RO and IBC, labs shall be reviewed prior to receipt or use of a select agent and at least annually thereafter. The RO (or designee) will conduct the reviews in a manner sufficient to ensure compliance with the procedures and protocols of the Biosafety Plan. The Biosafety Plan must be reviewed annually and a drill or exercise conducted annually. As a minimum, reviews shall entail:
- review and assessment of the Biosafety Plan,
- inspection of referenced safety and containment equipment,
- survey of the lab’s facility components.
Results from the reviews shall be documented and the records retained by the RO. Any identified deficiencies shall be immediately corrected or addressed in action plans that are subject to periodic monitoring by the RO (or designee).
For the purposes of E-4. Biosafety, the designee shall be either the BSO or an ARO.
E-5. Security. In order to use any select agents or toxins at UI, the investigator must develop and implement a written Security Plan. The plan must ensure the security of areas containing select agents or toxins. The Security Plan must be designed according to a site-specific risk assessment and must provide graded protection based upon the threat posed by the agent or toxin.
The USA PATRIOT Act of 2001, makes it a federal crime for an individual to ship, transport, receive, possess, or participate in transactions involving a select agent or toxin if he or she:
- Is under indictment for a crime punishable by imprisonment for a term exceeding one year (a felony);
- Has been convicted in any court or received deferred adjudication for a crime punishable by imprisonment for a term exceeding one (1) year (a felony);
- Is a fugitive from justice;
- Unlawfully uses any controlled substances (as defined by § 102 of the Controlled Substances Act (21 U.S.C. § 802));
- Is an alien illegally or unlawfully in the United States;
- Has been adjudicated as a mental defective or committed to any mental institution;
- Is an alien (other than an alien lawfully admitted for permanent residence) who is a national of a country that the Secretary of State of the United States has determined has repeatedly provided support for the acts of international terrorism (Iran, Syria, Cuba, and Sudan. See the list of designated "State Sponsors of Terrorism" maintained by the Secretary of State, Office of the Coordinator for Counterterrorism);
- Has been discharged from the Armed Services of the United States under dishonorable conditions.
A template to assist laboratories in writing site-specific security plans to address requirements of the federal regulations may be found on the NSAR website. The security plan must be reviewed annually and a drill or exercise conducted annually. For all SRA-approved individuals, the Select Agent on-line training is required annually.
E-6. Incident Response. In order to use any select agents or toxins at UI, the investigator must develop and implement a written incident response plan. The incident response plan must meet the requirements of OSHA (Occupational Safety and Health Administration) Hazardous Waste Operations and Emergency Response Standards (HAZWOPER) at 29 CFR 1910.120. The incident response plans will be coordinated University-wide through the Police and Fire Services.
The incident response plan must address such events as bomb threats, severe weather (tornadoes, floods), earthquakes, power outages, and other natural disasters or emergencies. The incident response plans must also address containment, inventory control, and notification of managers and responders.
The incident response plan must be reviewed annually and a drill or exercise conducted annually.
E-7. Training. Information and training on Biosafety and security for working with select agents or toxins must be provided to all individuals prior to access of any select agents or toxins at UI. All individuals who work in, or visit, the areas must understand the hazards of select agents or toxins present in the area.
Information and training must be provided at the time of an individual’s initial assignment to work in an area where select agents or toxins are present and prior to assignments involving new exposure situations. The PI (or designee) must provide training for individuals in their labs working with select agents or toxins. The PI and BSO will keep records of the individuals trained, date of training, and means used to verify that the employee understood the training. Refresher training must be provided and documented annually.
Any individual with access to select agents or toxins must have the appropriate education and training to handle or use such agents or toxins.
E-8. Transfers. Select agents or toxins may only be transferred to an individual or entity registered to possess, use, or transfer that particular agent or toxin. Select agents or toxins may be transferred after approval from the RO and either CDC or APHIS by completing APHIS/CDC Form 2. At UI, select agents or toxins may be received only after approval from the Institutional Biosafety Committee (IBC), the RO, and either CDC or APHIS. The authorization for transfer (APHIS/CDC Form 2) is valid only for thirty (30) calendar days after issuance.
All select agents or toxins shipped to UI must be received by individuals registered and approved for unescorted access to select agents or toxins. The package must be sent via FedEx (or comparable shipper) with instructions to deliver only to the authorized individual (who must sign for the package). The transfer package should be opened in the appropriate laboratory setting. The transfer package is to be opened by an authorized, registered individual in the presence of the RO (or his/her designee). The witness is required in order to have independent verification that the correct amount of transferred material is received. In the event that the RO or designee is not available, the package may be opened by the authorized, registered individual with any other SRA-approved individual as a witness.
The RO (or his/her designee) must be immediately notified regarding the receipt of the materials. The RO must provide a completed copy of the APHIS/CDC Form 2 (which documents the transfer and receipt of the select agent and/or toxin) to the sender and to the HHS or USDA Secretary within 2 business days after receipt of the materials.
The recipient must immediately notify CDC or APHIS if the select agent or toxin has not been received within forty-eight (48) hours after the expected delivery time or has been damaged to the extent that a release of the select agent or toxin may have occurred.
For the purposes of E-8. Transfers, the designee of the RO shall be either the BSO or an ARO.
Appendix A contains the UI procedures for transferring or receiving select agents or toxins.
E-9. Records. The RO and Principal Investigator must maintain complete, up-to-date records of information necessary to give a complete accounting of all the activities related to select agents or toxins. All records must be maintained for three years from the time they are created.
Records that must be maintained include:
a. A current list of all individuals with access to agents or toxins.
b. Accurate current inventories of each select agent or toxin held. The inventory must include:
1) The name, characteristics, and source data;
2) The quantity held on the date of the first inventory (toxins only);
3) The quantity acquired, the source, and date of acquisition;
4) The quantity, volume, or mass destroyed or otherwise disposed of and the date of each action;
5) The quantity used and date(s) of the use (toxins only);
6) The quantity transferred, the date of transfer, and individual to whom it was transferred (this includes transfers within an institution when the sender and the recipient are covered by the same certificate of registration);
7) The current quantity held (toxins only);
8) Any select agent or toxin lost, stolen, or otherwise unaccounted for;
9) A written explanation of any discrepancies;
c. For access to select agents or toxins the following records must be kept:
1) The name of each individual who has accessed any select agent or toxin;
2) The select agent or toxin used;
3) The date when the select agent or toxin was removed, if removed from long-term storage or holdings for stock cultures;
4) The quantity removed (toxins only);
5) The date the select agent or toxin was returned to long-term storage or holdings for stock cultures;
6) The quantity returned (toxins only);
7) A chain-of-custody form must be used to document the movement and ownership of the select agent or toxin from removal from storage, transport to approved lab, use, and destruction.
d. For access to the area where select agents or toxins are used or stored the following records must be kept:
1) The name of each individual who has accessed the area;
2) The date and time the individual entered the area;
3) The date and time the individual left the area;
4) The name of the escort must be recorded along with recording the access of individuals not approved for unescorted access to select agents or toxins.
e. The following programmatic records concerning select agents or toxins must be maintained:
1) Records concerning all inspections;
2) Safety, security, and emergency response plans;
3) Training records;
4) Transfer documents (CDC Form EA-101) and permits;
5) Safety and security incident reports;
A system is required to ensure that all records and data bases created are accurate, have controlled access, and that their authenticity may be verified. All paper records must be stored in locked file cabinets in locked offices at UI. No records should be kept outside of UI property. Only authorized individuals (SRA-approved) may have access to the locked file cabinets. Authenticity of paper records is verified by signatures and dates in ink. All computer records must be stored on password protected computers on networks with appropriate firewalls and network security.
E-10. Notification for Theft, Loss, or Release. Anyone authorized to work with select agents or toxins at UI must immediately notify the UI Police (by calling 911) and the RO or the ARO upon discovery of theft, loss, or release. The RO must notify CDC and/or APHIS and the appropriate Federal, State, or local law enforcement. The initial notification to CDC/APHIS can be either by telephone, facsimile, or e-mail. Thefts or losses must be reported whether the select agents or toxins are subsequently recovered or the responsible parties identified. Within seven (7) calendar days of theft, loss, or release, the RO must submit a follow-up report in writing on the APHIS/CDC Form 3.
The Theft Loss Release guidance document available at the NSAR site is to be followed regarding activities that qualify for notification. Review and understanding of this document is part of the training requirement in the Biosafety Plan.
E-11. Destruction of Select Agents or Toxins. Principal Investigators must notify the RO at least ten (10) business days prior to the destruction of any select agents or toxins, if the purpose of the destruction is to discontinue activities with a select agent or toxin covered by a certificate of registration. A chain-of-custody form must document the destruction. At UI the RO, ARO, or BSO, must witness the destruction of any select agents or toxins.
The RO must notify the CDC or APHIS immediately after destroying a select agent or toxin by submitting a revised application (APHIS/CDC Form 1).
1) RO/ARO/BSO. In addition to those responsibilities enumerated in E-3 above, the RO:
a) Ensures that receipt, storage, and issue of Select Agents at UI are in compliance with federal and state regulations. (BSO)
b) Provides assistance to laboratory personnel in inventory control procedures, secure storage, and proper disposal of select agent or toxins. (BSO)
c) Maintains records (APHIS/CDC Form 2) on all interfacility transfers of select agents or toxins at UI. Records of interfacility transfers are retained for a period of five years after the date of shipment or for five years after the select agents or toxins are consumed or properly disposed, whichever is longer. (RO)
d) Maintains the UI Select Agent or Toxin Registration issued by CDC/APHIS. Provide CDC/APHIS updated information on any additions, deletions, or changes to the UI registration. (RO)
e) Track any changes in federal regulations regarding select agents or toxins and inform the IBC and UI community of these changes. (ARO/BSO)
2) Institutional Biosafety Committee (IBC)
a) Reviews all research protocols through MUA submissions.
b) Provides periodic reviews of UI select agent or toxin policy or procedures.
c) Supplies researchers with interpretations or answers to questions regarding select agent or toxin use.
d) Reviews MUAs for use of select agents or toxins.
e) Updates UI policy/procedures in response to any changes in the regulations. The IBC will provide investigators with the new information.
3) UI Investigators
a) Review, confirm, and communicate requirements for working with select agents or toxins in laboratories for which they are responsible.
b) Provide training for all personnel (students, postdocs, research technicians, etc.) authorized and approved for working with select/biological agents prior to initiating the work. Document the training in writing.
c) Maintain accurate records of receipt, use, relocation, and disposal of select agents or toxins for which they are responsible.
d) Maintain current inventory records, records of access to select agent or toxin areas, and records of access to select agents or toxins (see E-9 above).
e) Forward information regarding method and date of select agent or toxin disposal to the responsible official (RO).
f) Keep all select agents or toxins secure and assure that only approved individuals have access to them.
g) Comply with any changes in this policy, as these changes occur in response to changes in federal regulations or university policy.
E-13. Non-Disclosure Policy. UI requires that authorized users not disclose any information regarding the location, inventory, or security of select agents or toxins to non-authorized individuals.
Appendix A. UI Procedures for Transferring or Receiving Select Agents and Toxins (42 CFR 73), and Biological Agents and Toxins (7 CFR 331 and 9 CFR 121)
UI Procedures for Transferring or Receiving Select Agents and Toxins (42 CFR 73), and Biological Agents and Toxins (7 CFR 331 and 9 CFR 121)
A. Procurement of select agents or toxins.
1. The procurement of all select agents or toxins will be accomplished only with the prior approval of the Institutional Biosafety Committee (IBC) through an MUA and the Responsible Official’s (RO’s) signature on the APHIS/CDC Form 2.
2. A UI employee, who is requesting to obtain a select agent or toxin, must complete an MUA to be submitted to the IBC. The laboratory must also be included in the UI registration with CDC/APHIS of laboratories and personnel that are authorized to possess, use, and transfer select agents or toxins.
a) If the lab is not registered for the select agent or toxin, then the lab must register (or modify its registration) by completing APHIS/CDC Form 1.
b) If the lab is already registered for the select agent or toxin, then APHIS/CDC Form 2 must be completed to transfer the material to UI.
The BSO is available to help researchers understand and comply with the requirements to register a laboratory and possess, use, and transfer select agents or toxins. The completed materials should be forwarded to the BSO for review. Any additional requirements for receiving a select agent or toxin will be discussed at that time. The BSO will then provide the completed materials to the Chief Research Compliance Officer, (ARO) who will review the material and obtain the signature of the RO.
Requirements for receiving select agents or toxins may include:
a. Review of research protocol by the IBC at the time the MUA is submitted.
b. Inspection of laboratory and animal facilities and review of SOP’s, storage and disposal by EH&S and/or the Office of Research Assurances Manager and Campus Veterinarian.
c. Consideration of training of personnel working with the Select Agent(s).
B. Select agents or toxins inventory and transfer. Select agents and toxins inventories must be maintained for control purposes. E-9 of the "UI Procedures for the Possession, Use, and Transfer of Select Agents or Biological Agents and Toxins" details the record keeping and inventory requirements.
1. The principal investigator is responsible for the maintenance of these records.
2. Each principal investigator shall keep accurate records of receipt, disposal of (final disposition of select agents requires immediate notification to CDC and/or APHIS on APHIS/CDC Form 1) and relocation of all select agents or toxins for which he/she is responsible. Intrafacility (within UI) transfer records shall include the name and location of the recipient; the amount of agent transferred, the date of transfer, and the intended use of the agent.
Intrafacility transfer records must be maintained for a period of five years after the date of transfer or for five years after the agents are consumed or properly disposed, whichever is longer. Intrafacility transfer of select agents or toxins requires prior approval by the IBC and the RO. All requests for intrafacility transfer of materials containing select agents or toxins must be documented on the "UI Use and Transfer of Select Agents and Toxins Intrafacility Transfer Request" (form located at the end of this appendix) and submitted to the UREDO prior to the intrafacility transfer. Transfer of any amount of select agents or toxins to unauthorized areas is prohibited. ORA reserves the right to periodically audit all inventory, intrafacility transfer records, and other select agent or toxin related records kept by the Principal Investigator. Any laboratories receiving select agents or toxins via an intrafacility transfer must have an approved MUA and be included and approved on UI’s APHIS/CDC registration (APHIS/CDC Form 1).
3. All select agents or toxins must be shipped from and to UI through FedEx or other equivalent carrier. The sender of select agents or toxins must comply with all applicable laws concerning packaging and shipping.
Prior to the transfer of a select agent or toxin an APHIS/CDC Form 2 must be completed. The APHIS/CDC Form2 will be jointly completed by all involved parties and approved by CDC or APHIS prior to transfer. The form must have the following information:
a. The name of the sender and sending facility;
b. The name of the recipient and recipient facility;
c. The name of the sender and recipient facility’s Responsible Official (RO);
d. The recipient and sender facility’s CDC/APHIS registration #;
e. The name of the agent being shipped;
f. The proposed use of the agent; and
g. The quantity (# of containers and amount per container) of the agent being shipped.
The APHIS/CDC Form 2 must be signed by the sender and recipient, and the responsible officials (ROs) of both facilities. All APHIS/CDC transfer procedures must be followed. An authorization to transfer is valid for only 30 calendar days after issuance.
When UI receives select agents or toxins a copy of the completed APHIS/CDC Form 2 will be faxed to CDC or APHIS by the RO within 2 business days of the receipt of the select agents or toxins. If the select agent or toxin has not been received within 48 hours of the expected delivery time, or if the package is leaking or otherwise damaged the recipient RO will immediately notify CDC or APHIS.