45.20 -- Select Agents and Toxins

June 30, 2010January 9, 2014

PREAMBLE: This section outlines the legalrequirements and procedures required for the possession, use, and transfer of Select Agents and Toxins.

CONTENTS:

A.Introduction

B.Legal Authority

C.Scope

D.Definitions

E.Procedures

E-1. Registration

E-2. Security Risk Assessment

E-3. Responsible Official

E-4. Biosafety

E-5. Security

E-6. Incident Response

E-7. Training

E-8. Transfers

E-9. Records

E-10. Notification for Theft, Loss, or Release

E-11. Destruction of Select Agents or Toxins

E-12. Responsibilities

E-13. Non-Disclosure Policy

Appendix A: Transferring & Receiving Procedures

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 (42CFR 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 ofselect 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 42CFR 73 (“Possession, Use, and Transfer of Select Agents and Toxins”). The APHIS introduced 7CFR 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 Researchand 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 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. Definitions:

D-1. Biological Agent – Any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), orinfectious 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 UIselect 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 Presidentof Research and Economic Development. Alternate ROs for UIare the Associate VicePresident 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 BiosafetyPlan 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 Guidelinesfor 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 availablefrom 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.