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. This Standard applies to all personnel engaged in the care of animals maintained within a Satellite Animal Facility. A Principal Investigator (PI) must seek IACUC approval for a Satellite Animal Facility if they must maintain animals long-term in a PI-managed space (i.e., long-term animal housing outside of a Division of Comparative Medicine [DCM] housing 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) which includes Section 3.3 describing a Satellite Animal Facility and approval of the physical 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 physical satellite space. Satellite Animal Facilities are approved in rare instances where there is appropriate justification based on experimental needs (not convenience) and must be reviewed at a convened meeting of the IACUC.   

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.

NO ANIMALS ARE ALLOWED TO BE HOUSED FOR A PERIOD LONGER THAN 12 (USDA covered species) or 24 (non-USDA covered species) HOURS IN THE INVESTIGATOR’S LABORATORY OR THE PROPOSED SATELLITE FACILITY UNTIL RECEIPT OF WRITTEN IACUC APPROVAL OF THE EXCEPTION.

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. PI consultation with DCM about whether there is appropriate space in DCM facilities, and if not, identify suitable space outside DCM facilities to use as a satellite.
2. Contact OACU to start the process of preparing written justification describing need for a Satellite Animal Facility. The written justification will be reviewed at a fully convened IACUC meeting (including completion of section 3.3 in the protocol) and will be approved if the justification is appropriate, if the housing cannot not be achieved in DCM facility and if the request is not based on convenience.
3. Initial inspection of proposed Satellite facility by IACUC, OACU, DCM, and EHS representatives.
4. Collection of temperature and humidity data (high/low) over a 5 day period, except when animals will be continuously housed in a climate controlled equipment (e.g., Biocabinets, incubator). For Satellite spaces consisting only of an incubator, the PI should provide IACUC/OACU with manufacturer specifications.
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 by IACUC, OACU, EHS, and DCM of required modifications.
8. Written approval from the IACUC.
9. Two keys (or key code) provided by PI to OACU. One will be provided to DCM.

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), followed by a written justification provided to the OACU to present at the next fully convened IACUC meeting. 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 for scientific reasons.

If the IACUC approves the satellite facility justification, the investigator may begin coordinating an initial inspection of the proposed site. IACUC, OACU, 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, OACU, 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 justification for a PI-maintained Satellite Facility;
2. written notification from the IACUC indicating approval of the space; and
3. 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 (UEOHC) 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 be the same as for animals housed in a DCM facility.

Semi-annual IACUC inspections of each Satellite Animal Facility are federally mandated. At UNC-Chapel Hill, Satellite facility physical inspections are conducted semiannually with additional record review conducted semiannually resulting in review 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 Facility 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, the PI must submit a Request for an Exception in ACAP for full IACUC review and approval.
3. Accessibility/Security: The PI is responsible for ensuring that the Satellite facility is always locked when unoccupied by research personnel. Discrete signs should be posted instructing housekeeping to not enter the space when animals are present. The Satellite Animal Facility must be accessible to IACUC and DCM representatives at all times. The PI must provide a minimum of two (2) keys or the entry codes to facilitate IACUC and DCM access to the facility.
4. Biosecurity: Personal protective equipment (PPE) must be made available at all times and will be provided by the investigator’s lab. 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 arrange with DCM.
5. Disaster Plan: 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 Satellite facility. The plan must indicate Mandatory Employees to ensure continuity of animal care during University Conditions 2 & 3, when all non-mandatory operations are suspended and non-mandatory employees are not allowed to report to work. All student workers are considered non-mandatory and should be encouraged to leave the area. Please see the University's Adverse Weather and Emergency Event Policy for more details. (Described in the UNC-Chapel Hill Adverse Weather and Emergency Events Policy and Pandemic and Communicable Disease Emergency Policy).

The names and contact information for two mandatory employees, as well as a detailed description of a plan and backup plan for animal care during emergencies must be included. It is expected that labs provide care to animals in their satellite facilities during these conditions above. Additionally, the lab needs to have a plan with DCM, such that there is advance coordination and training of DCM personnel in the rare case that DCM needs to provide husbandry in an emergency. (Include DCM contact information to be used in case of emergency, and describe training provided to DCM). In the case of imminent adverse weather in which only mandatory employees are allowed on campus, PIs should refrain from starting any studies. DCM will not provide study-related care during emergencies and will terminate the study in such cases.

6. Contact Information: Current 24-hour contact information should be posted on the door of the Satellite facility so that the PI/LAC/researchers can be contacted in the event of an emergency.
7. Animal Identification: All animals must be identified by a current IACUC approved protocol (e.g., with DCM RFID cage cards or another approved method), and the date the animal was brought to the Satellite Animal Facility.
8. Required 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 always be available in the facility 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. It is acceptable to maintain current IACUC Protocol number and Satellite Facility SOP documents within a notebook in the room, which is accessible to inspectors. Signage: All required safety signage (EHS), IACUC signage, husbandry documentation, and after-hours emergency contact information must be present in the facility The UNC-Chapel Hill notice "Reporting Animal Welfare Concerns or Animal Protocol Noncompliance" and contact information for animal health (veterinary) concerns must be visibly posted within the Satellite facility. The PI is responsible for posting and maintaining an accurate emergency contact information sheet in the Satellite Animal Facility. The posting must include the PI, 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.
9. Training: It is the PI’s responsibility to ensure that everyone working in the approved Satellite 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.
10. Occupational Health: The PI is responsible for complying with all UNC-Chapel Hill occupational health requirements stipulated by the University Employee Occupational Health Clinic (UEOHC). This includes ensuring that all persons who are exposed to animals being held in the Satellite facility are enrolled with the UEOHC. The Research Profile and Animal Handler Form can be found on the Research website. Additionally, appropriate personal protective equipment (PPE) is required.
11. Hazards: The PI is responsible for complying with EHS requirements and all other applicable local, state and federal rules and regulations regarding physical, radiological, biological and chemical hazards. The PI is responsible for notifying all personnel (including IACUC) of any hazards present, using the required cage cards and/or signs, and assuring that all personnel are aware of potential hazards, and properly trained to avoid any hazard present.
12. Sanitation: The PI is responsible for complying with species-specific sanitation requirements as per DCM SOPs. The space must be easily cleaned and sanitized with approved supplies. Please see Sanitation requirements in more detail below in SOP Section II. An extensive cleaning routine should be outlined by the PI and may be performed when animals are not present.
13. 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 an animal escapes?
   3. If an animal contacts 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.
   1. What is the procedure for checking animals?
   2. What clinical or behavioral signs denote an animal may be sick or otherwise compromised?
   3. What steps are taken with this animal and to whom does the investigator report the health case (supervisor, DCM veterinary services)?
5. Emergency Operations:
   1. 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). Specifically, the PI must identify the names and contact information for two (2) Mandatory employees, as well as a detailed description of a plan and backup plan for animal care during emergencies. It is expected that labs provide care to animals in their satellite facilities during these conditions. Advanced coordination and training with DCM personnel is required to ensure emergency backup husbandry for on-campus satellite facilities. (Include DCM contact information to be used in the case of emergency, and describe training provided to DCM.)

Please indicate the names and contact information of the Mandatory Employees: ________ or DCM plan here ___________.

In the case of imminent adverse weather in which only mandatory employees are allowed on campus, investigators should refrain from starting any studies. DCM will not provide study-related care during emergencies and will terminate the study in such cases.

6. 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. Expiration dates should be clearly marked on feed.
   5. How often and how much is given of both feed and water (if applicable)?.
   6. Describe water treatment and water quality assessment.
   7. What is done with excess food in the enclosure?
7. 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 primary 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 the justification? (Include justification as part of an Exception request in Section 8 of protocol.
8. Procurement of animals
   1. How are animals transported to the housing location (shipped, hand-delivered, etc.)?
   2. Are health checks conducted upon arrival; who conducts the health check?
9. 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 requirements as per DCM’s SOPs. Any hand-washed items are required to undergo annual microbial testing by DCM. The housing area must be easily cleaned and sanitized. (Complete all aspects of charts below):

Sanitation

Microenvironment (primary enclosures)	Washing/Sanitizing Method (mechanical wash, hand wash, high pressure sprayers, etc.)	Washing/ Sanitizing Frequency	Tools and Detergents Used	Temperature of Water Used
Cage Lids
Filter
Cage Rack and Shelves
Aquatic, Amphibian, and Reptile Tanks and Enclosures
Feeders
Watering Devices
Exercise Devices and Manipulanda used in Environmental Enrichment Programs, etc.
Transport Cages

Sanitation

Macro-Environment: Rooms, Floors, Wash Areas	Washing/Sanitizing Frequency	Detergents/Agents used	Environmental Monitoring (with DCM) Yes/No
Animal Room Floors
Animal Room Walls
Animal Room Ducts/Pipes
Animal Room Fixtures
Support Area* Floors
Support Area Walls
Support Area Ceilings
Support Area Ducts/Pipes
Support Area Fixtures
Implement* Mops
Implement* Mop Buckets
Implement* Aquaria Nets
Implement* Other
Other:
*Support Areas include: (e.g. surgery, procedure rooms, etc.) *Implements: Note whether or not shared

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.

Adequacy of Space

Species	Dimensions of Enclosure (cage, pen, tank*, corral, paddock, etc.)	Maximum Number Animals/ Enclosure	Guiding document used to determine the Institution’s space standards (Guide, AG Guide, ETS 123, Other)	Enclosure Composition & Description**
*For aquatic species, provide tank volume. **Include descriptors such as open-topped, static microisolator, individually-ventilated cage systems (IVCS).

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

Policy Contact

• Name: Michael Chi
• Title: Associate Director, Office of Animal Care and Use
• Email: mchi@unc.edu

Subject: Animal Health

• Contact: DCM Vet Services
• Telephone: 919-962-5535

Subject: Office of Animal Care and Use

• Telephone: 919-966-5569
• Email: iacuc@med.unc.edu

Subject: Laboratory Safety

• Contact: Environment, Health and Safety
• Telephone: 919-962-5507

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.; Revised 11/2024

 

Approved by: UNC-CH IACUC