I. PURPOSE, SCOPE and APPLICABILITY

I.A. The purpose of these procedures is to ensure that all federally regulated Select Agents at the University of New Hampshire are handled safely, secured properly, and registered with the UNH Institutional Biosafety Committee (IBC), Department of Health and Human Services (DHHS), Centers for Disease Control and Prevention (CDC) and/or the United States Department of Agriculture (USDA), Animal Plant Health Inspection Service (APHIS).

I.B. These procedures describe the requirements for the possession, use, receipt and transfer of Select Agents. These requirements are designed to protect against misuse of Select Agents. Possession, use, transfer and disposal of these agents may not occur without approval of the UNH CDC Responsible Official (Director of the Office of Environmental Health Safety, OEHS) and Principal Investigator (PI).

I.C. This procedure applies to University faculty and staff, students and visitors who receive, possess, use, transfer or acquire Select Agent(s) at UNH.

II. DEFINITIONS

II.A. “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.

II.B. "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.

II.C. "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.

II.D. “Access” means the ability to obtain or use of Select Agents. Only authorized persons are permitted access to Select Agents. 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 after they have received Select Agent training and if they are escorted and monitored by an "Authorized Person."

II.E. “Authorized person” is an individual who has been approved for access to Select Agents through the successful completion of a DOJ/FBI security risk assessment and has been approved by the UNH IBC.

II.F. “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 procedure, the entity is the University of New Hampshire.

II.G. “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 procedure, the RO is the director of OEHS, the alternate RO is the Institutional Biosafety Officer.

II.H. “Restricted Person” means any individual who:

Is under indictment for a crime punishable by imprisonment for a term exceeding one year;

Is a fugitive from justice;Is an unlawful user of any controlled substance (as defined in Section 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 has been committed to any mental institution;

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 act of international terrorism; or

Has been discharged from the Armed Services of the United States under dishonorable conditions.  

Restricted persons are prohibited from having access to Select Agents.

III. ROLES and RESPONSIBILITIES

III.A. The director of OEHS is the Responsible Official (RO) for the University of New Hampshire. All activities involving registration with federal agencies, intramural or extramural transfers, disposal and exclusion or exemption from regulation must be coordinated through OEHS and reviewed and approved by the RO. The RO submits all applications to CDC and/or USDA.

III.B. The Institutional Biosafety Officer is the Alternate RO (ARO) for the University of New Hampshire. The ARO conducts the duties of the RO when the RO is unavailable.

III.C. 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 for the scientific and technical direction of the project or program.

III.D. 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.

III.E. Restricted persons are prohibited from having access to Select Agents.

IV. PROCEDURES

IV.A. Select Agent Registration

IV.A.1. PI's considering work with any Select Agent material must complete a "IBC Registration Form for Infectious Agents and Recombinant DNA Molecules" and submit it to the UNH IBC for approval. This applies to exempt select agents as well as those that require federal registration.

IV.A.2. PI's wishing to use recombinant DNA technology with any Select Agent material must complete a "IBC Registration Form for Infectious Agents and Recombinant DNA Molecules" and submit it to the UNH IBC for approval. This applies to exempt select agents as well as those that require federal registration.

IV.A.3. PI's who fall under the regulations, must register their intent to use Select Agent materials with the CDC and/or APHIS PRIOR to bringing Select Agent materials to UNH. PI's, in collaboration with OEHS staff, must complete the application packet and submit it to the RO for submission to CDC and/or APHIS.

IV.B. Exclusion / Exemption

IV.B.1. Certain Select Agent materials that meet regulatory criteria are exempt from registration with the CDC and/or APHIS. Click here for a list of agents and known exemptions. Select Agents may not be destroyed until the RO/ARO has approved the method of destruction.

IV.B.2. PI's, in collaboration with the RO, may request specific exclusion of materials they do not consider to fall under regulation. A current list of attenuated strains of select biological agents and toxins that are excluded from the Act can be found at http://www.selectagents.gov/Exclusions.html. 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 OEHS. 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.

IV.C. Personnel Security Risk Assessment

IV.C.1. Prior to working with or having access to Select Agents all individuals must undergo a security risk assessment (including fingerprinting) by the DOJ/FBI.

IV.D.Training

IV.D.1. Select Agent training, provided by OEHS, is required for authorized persons who are allowed access to Select Agents.

IV.E. Security

IV.E.1. 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 enclosed in a refrigerator/freezer/cabinet. Select Agents must be controlled and maintained at all times.

IV.F. Records

IV.F.1. The RO must keep an up-to-date accurate list of all individuals approved for Select Agent access.

IV.F.2. The RO must maintain records pertaining to inspections; safety, security and emergency response plans; training; transfer documents and incidents reports.

IV.F.3. Principal investigators must maintain a current and accurate Select Agent inventory as described in the relevant regulations.

IV.F.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 exit for:

• all approved users

• others, along with the name of the approved escort.

IV.F.5. All records and logs must be kept for a minimum of 3 years.

IV.G Transfers

IV.G.1. Extramural transfers of Select Agents may not occur without prior authorization of the ROs at the facilities of the sender and recipient.

IV.G.2. Intramural transfer of the Select Agents must be approved by the RO before the transfer occurs.

IV.H. Destruction and Disposal

IV.H.1. Destruction and disposal of Select Agents must be done in accordance with federal procedures. The RO and/or ARO must be present for the destruction of Select Agents. The PI must document the time, date and method of destruction. The appropriate federal agency must be notified by the RO three (3) working days after the destruction of any Select Agent biological agents or toxins.

IV.I. Clinical and Diagnostic Laboratories

IV.I.1. 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 OEHS for further instructions.