Standard on Satellite Animal Facilities

Title

University of North Carolina at Chapel Hill Standard on Satellite Animal Facilities

Introduction

Purpose

The standards and procedures described in this document provide guidance to all researchers and animal handlers for the establishment and maintenance of a Satellite Animal Facility.

Scope

This Standard applies to all personnel engaged in the care of animals maintained within a Satellite Animal Facility.

The University of North Carolina at Chapel Hill ("UNC-Chapel Hill" or "University") Institutional Animal Care and Use Committee (IACUC) expects that anyone involved in animal work at the University will comply with this Standard. Requests for exceptions to this Standard must be reviewed and approved by the IACUC. Principal Investigators (PIs) anticipating the need for an Animal Procedural Space Exception (APSE) should contact the Office of Animal Care and Use (OACU).

Standard

Federal regulations state that the authority and oversight of Satellite Animal Facilities lies with the institution through the IACUC.

Approval of an Animal Care Application (ACAP) and approval of a Satellite Animal Facility are two separate requirements. Approval of an application with a Satellite Animal Facility request does not imply or guarantee automatic IACUC approval of the proposed Satellite Animal Facility. Satellite Animal Facilities are approved in rare instances where there is appropriate justification based on experimental needs (not convenience).

In addition, IACUC approval of a proposed Satellite facility will be granted only if the space meets IACUC, Environment, Health and Safety (EHS), Division of Comparative Medicine (DCM), and the Guide for the Care and Use of Laboratory Animals (Guide) standards. The process of Satellite Animal Facility approval is dependent on several factors and the process can take a considerable amount of time.

Prior to housing animals in the proposed space, the required steps for development of a Satellite Animal Facility at UNC-Chapel Hill are as follows:

1. Consult with Division of Comparative Medicine (DCM) and OACU about whether there is appropriate space in DCM facilities, and if there is not appropriate space in DCM facilities- identify suitable space outside DCM facilities to use as a satellite.
2. Written justification describing need for a Satellite Animal Facility, reviewed and approved at a fully convened IACUC meeting (including completion of section 3.3 in the protocol).
3. Initial inspection of proposed Satellite facility by IACUC, DCM, and EHS representatives.
4. Collection of temperature and humidity data (high/low) over a 5 day period, except in incubator housing, or continuous testing in which animals are maintained in climate-controlled equipment (e.g., Biocabinets).
5. Satellite Animal Facility Standard Operating Procedures (SOP) (included in this document).
6. Satellite Disaster Plan with satellite specifics described in section F. - Available for download from the IACUC website.
7. Final inspection of required modifications to improve space.
8. Written approval from the IACUC.
9. Two (2) keys (or key code) provided by PI to OACU.

Approval of a Satellite:

The approval process requires that the investigator initially submit a request with justification to the IACUC through ACAP (by completing section 3.3). Justification for a proposed satellite facility cannot be based on convenience. Rather, it must be based on factors such as the inability to house animals in a DCM facility, the inability of DCM to provide the desired space, care, or scientific reasons.

If the IACUC approves the satellite facility justification, then the investigator can begin coordinating an initial inspection of the proposed site. IACUC, DCM, and EHS representatives must be included in the initial inspection. These representatives will help identify any potential problematic issues such as cluttered space, improper storage of equipment, re-circulating or inadequate air exchange, and the inability to control temperature, humidity, and light cycles. The investigator’s written documentation indicating correction of previously identified issues will prompt IACUC, DCM and EHS representatives to re-inspect the proposed site.

Prior to using the space to house animals, the PI requesting the Satellite Animal Facility must receive both of the following:

1. written notification from the IACUC indicating approval of the space; and
2. approval of Section 3.3 in ACAP describing the Satellite space.

Post Approval Maintenance of a Satellite:

It is the PI’s responsibility to ensure that all federal and institutional requirements are implemented consistently. This includes the care and use of all animals, seven days a week including weekends and holidays, and also Emergency/Adverse Weather situations. (see pg 6 - Procedures included in the Satellite SOP, item C. iv. regarding contacting DCM in emergencies).

The PI is responsible for compliance with EHS policies for the space including complying with the University’s Chemical Hygiene Plan, submitting a laboratory safety plan, and following policies outlined in the University's Laboratory Safety Manual. In addition, the PI must check and maintain safety controls within the space (e.g., chemical fume hoods, biological safety cabinets, safety eye washes, and safety showers).

The PI is responsible for ensuring that all personnel exposed to animals are enrolled in the University Employee Occupational Health Clinic Program through completion of the Animal Handler Form. This form should be updated annually. The PI must ensure that all personnel involved in animal handling are properly trained. Veterinary and IACUC Compliance oversight will continue as if the animals were housed in a DCM facility.

Semi-annual IACUC inspections of each Satellite Animal Facility are federally mandated; however, at UNC, Satellite facility inspections are conducted on a quarterly basis. Failure of the PI to meet all required expectations may result in the loss and decommissioning of the Satellite Animal Facility.

Satellite Animal SOP

The PI must use this Satellite Facility SOP to design the proposed space. The individual Satellite Animal Facility SOP must address each topic in a detailed manner and must be approved by DCM Veterinarians, EHS, and the IACUC. The PI must maintain and update annually a final approved copy in the Satellite Animal Facility SOP. Laboratory staff responsible for provision of care within the Satellite Animal Facility must review the SOP annually.

Standardization of Procedures:

The Guide states “While the animal use protocol is aimed at describing the overall procedures, SOPs should be developed to standardize the completion of animal care procedures.”

1. Physical Plant: The facility must meet the minimum standards as set forth by the Guide . The PI is responsible for meeting or exceeding these standards at all times. The space must be clearly designated as an area reserved for animal housing only.
2. Experiment: Should any experiments or procedures need to be performed in the designated space, an exception must be submitted for full committee review and approval.
3. Biosecurity: A plan to prevent and resolve animal escape from the Satellite Animal Facility is required. For instance, a door sweep should be installed to prevent animals from crawling under the door space. An agreement must be made with the DCM facility supervisor on handling and return of caging materials borrowed from a DCM facility. If the PI wishes to return any animals to the DCM animal facilities, the PI must first make arrangements with DCM.
4. Animal Identification: All animals must be identified by a current IACUC approved protocol (e.g., with DCM RFID cage cards or an approved, acceptable method), and the date the animal was brought to the Satellite Animal Facility.
5. Documentation: In each Satellite Animal Facility, the PI must maintain daily husbandry documentation which includes the date, initials/signature of caretaker, and a description of all completed tasks (e.g., daily observation, feed, water, cage change, temperature, humidity, etc.). These log sheets must be available in the facility at all times for audit purposes (announced or unannounced). The PI must maintain the current approved animal protocol, the Satellite Animal Facility SOP, and the Satellite Disaster Plan in the satellite. These documents should be reviewed annually by personnel handling animals and updated as necessary.
6. Signage: All required safety signage (EHS), IACUC signage, husbandry documentation, and after-hours emergency contact information must be present in the facility. All animals must be identified by the current IACUC approved protocol number (i.e., with DCM animal identification cage cards or individual acceptable method), along with any physical markings/identifications. The PI is responsible for posting and maintaining an accurate emergency contact information sheet in the Satellite Animal Facility. The posting must include the Principal Investigator, Laboratory Animal Coordinator and/or satellite manager. DCM Veterinary Contact information must also be posted for animal health related issues. Current 24-hour contact information should be posted on the door within the Satellite Animal Facility so that the PI/LAC/researchers can be contacted in the event of an emergency.
7. Accessibility/Security: The Satellite Animal Facility must be accessible to IACUC and DCM representatives at all times. The Satellite Animal Facility PI must provide a minimum of two (2) keys or the entry codes to facilitate IACUC and DCM access to the facility. Personal protective equipment (PPE) must be available at all times. Additionally, the PI is responsible for ensuring that the Satellite Animal Facility is locked at all times when unoccupied by research personnel. Discrete signs should be posted instructing housekeeping to not enter the space when animals are present. An Essential Personnel must be indicated to ensure continuity of animal care during University Condition 2 & 3, when all non-mandatory operations are suspended and non-essential employees are not to report to work. All student workers are considered non-essential and should be encouraged to leave the area. Please see the University's Adverse Weather and Emergency Event Policy for more details.
8. Training: It is the PI’s responsibility to ensure that everyone working in the approved APSE space when animals are present is adequately trained in all animal-handling aspects. Training includes knowledge of the requirements for the Animal Biological Safety Level (ABSL) of the Satellite Animal Facility.
9. Husbandry Materials: All caging and materials such as food, water, bedding, enrichment device(s), cage cards and cleaning materials necessary for proper husbandry and care must be approved by DCM veterinarians (and described within this SOP), and provided by the PI. Storage should be limited to items necessary for housing the animals and all cardboard must be removed. Stored materials must be kept in sealed vermin proof containers. The milling date or date of expiration must be clearly indicated on animal feed.

Procedures to Be Included in the Satellite Animal Facility SOP:

Provide details for each of the following items. Include the frequency of each procedure and the level/position (not individual name for security purposes) responsible for the completion of each procedure. PIs should contact a DCM Veterinarian for consultation in development of the SOP.

I. Care of Animals: Animal handling (Consult with DCM Veterinarians and/or EHS)

1. Personal protective equipment (PPE)
   1. Indicate what PPE is necessary when handling the animals.
2. Zoonotic agents associated with this species
   1. What are they?
   2. Describe how animals are to be handled (captured & restrained)
   3. Are there any other risks such as bite wounds, etc. associated with this species?
   4. What are the clinical signs that might indicate that someone working with these animals has contracted a zoonotic disease?
   5. What precautions should be taken to protect staff?
3. Are there tools such as nets used for their capture or restraint?
   1. Are these tools dedicated to a particular animal or set of animals? (If so, indicate sanitization schedule in chart below)
   2. What should be done if animal escapes?
   3. If animal makes contact with the floor, should it be returned to the original primary enclosure or are there additional steps for cleaning/isolating this animal?
   4. Health checks: All animals must be checked daily, including weekends and holidays.
   5. What is the procedure for checking animals?
   6. The PI is responsible for ensuring that a disaster plan is in place in the event of an emergency which endangers the health and welfare of the animals maintained in the facility. Indicate how animals will be cared for in the event that the University is operating under conditions when only ‘Mandatory’ employees are allowed access to campus. (Described in the UNC-Chapel Hill Adverse Weather and Emergency Events Policy and Pandemic and Communicable Disease Emergency Policy). Advance coordination and training with DCM personnel is required to ensure emergency backup husbandry. (Include DCM contact information to be used in the case of emergency, and describe training provided to DCM.) Please indicate the name of the Essential Personnel: ________ or DCM plan here ___________.
   7. What clinical or behavioral signs denote an animal may be sick or otherwise compromised?
   8. What steps are taken with this animal and to whom does the investigator report the health case (supervisor, DCM veterinary services)?
4. Feed/watering of animals
   1. What type of food (brand/source) is used?
   2. How is this food stored?
   3. How is expiration date determined?
   4. How often and how much is given of both feed and water (if applicable)
   5. Describe water treatment and water quality assessment
   6. What is done with excess food in the enclosure?
5. Primary enclosures (tank or cage): Note: An agreement must be made with the DCM facility supervisor on handling cages borrowed from a DCM facility.
   1. Describe enclosure
   2. Indicate the number of animals (minimum and maximum) per enclosure
   3. Will animals outgrow their enclosure, and at what point will they be transferred to larger housing?
   4. Are animals provided enrichment? If not, what is justification?
6. Procurement of animals
   1. How are animals transported to housing location (shipped, hand-delivered, etc.)?
   2. Are health checks conducted upon arrival; who conducts the health check?
7. Quarantine procedures
   1. Is a separate tank/enclosure provided to quarantine new arrivals and/or sick animals?
   2. Where is the location of quarantine enclosure?
   3. Are special arrangements made to change workflow when dealing with sick or new animals so as not to introduce disease to the rest of the colony?
   4. Is the health of newly arrived animals monitored? If so, by whom (researcher, veterinarian)
   5. Is animal quality discussed with the vendor?

II. Sanitation

The PI is responsible for complying with species-specific sanitation requirement as per DCM’s SOPs. The housing area must be easily cleaned and sanitized. (Complete all aspects of charts below):

III. Primary Enclosures and Animal Space Provisions

Please complete the table below considering performance criteria and guiding documents (e.g. Guide, Ag Guide, ETS 123 and/or other applicable standards) used by the IACUC/OB to establish adequacy of space provided for all research animals including; traditional laboratory species, agricultural animals, aquatic species and wildlife when reviewing biomedical, field and agricultural research studies.

Exceptions

Requests for exceptions to this Standard must be reviewed and approved by the IACUC.

Related Requirements

External Regulations and Consequences

• U.S. National Institutes of Health. Guide for the Care and Use of Laboratory Animals, 8th edition.

University Policies, Standards, and Procedures

• For more detailed guidance, please refer to the University Policy on the Care and Use of Vertebrate Animals for Research, Training and Teaching Purposes.
• Chemical Hygiene Plan (Laboratory Safety Manual)
• Adverse Weather and Emergency Events Policy
• Pandemic and Communicable Disease Emergency Policy
• Emergency Management Policy
• Reporting Animal Welfare Concerns or Animal Protocol Noncompliance

Contact Information

Important Dates

• Effective Date and title of Approver: January 2009; UNC-Chapel Hill IACUC
• Revision and Review Dates, Change notes, title of Reviewer or Approver: Revised 04/2015; UNC-Chapel Hill IACUC; Revised 04/2016; Revised 11/2018, Placed on new Standard template, updated contact information and added hyperlinks; Revised 01/2019, Added information regarding Condition 2 & Condition 3 Essential Employees; UNC-Chapel Hill IACUC.

Approved by: UNC-Chapel Hill IACUC