This policy provides requirements for training, supervision, compliance, personal protective equipment, medical surveillance, accident reporting, and wound care to minimize accidents, injuries, and exposures sustained by NIH employees, contractors, and other personnel who work with nonhuman primates (NHPs) or enter rooms and areas containing NHPs.

1. Who this policy applies to: This policy applies to all employees, contractors, and non-federal staff1 in NIH facilities that conduct or support intramural activities involving animals. This policy also describes training requirements for Special Volunteers and Transient Visitors planning to enter nonhuman primate facilities.
2. Which facilities this policy applies to: This policy applies to NIH facilities that conduct or support intramural activities involving nonhuman primates except for NCI Frederick.

1 This includes students, trainees, fellows, guest-researchers, and volunteers.

Please see Appendix 2 for a list of defined terms used in this policy.

NIH intramural policy requires that each individual involved with the care and use of nonhuman primates be appropriately qualified and trained in the NHP procedures they conduct. Training must address the proper use of personal protective equipment (PPE), wound care, and reporting procedures for injuries and exposures.

All personnel including Transient Visitors, who have not been appropriately trained and will be entering facilities containing NHPs must be accompanied by a responsible facility staff member who is knowledgeable in the behavior and handling of NHPs. The facility staff member must be current with the required annual NIH training for users of live NHPs. Transient Visitors must meet the medical testing requirements established by the facility Animal Program Director prior to entering a NHP animal facility or room as noted in DOHS memorandum: Medical Clearance of Transient Visitors into NIH Animal Facilities.

Minors at least 16 years of age whether employees or visitors (defined in NIH Manual 3015) may not work with or be present for procedures or research activities involving awake NHPs and may not work with human and/or nonhuman primate blood, body fluids, and tissues. Additionally, minors under the age of 18 are not permitted in nonhuman primate holding rooms or areas where procedures with awake nonhuman primates are conducted.

Each individual with direct contact with nonhuman primates or their tissues or body fluids must participate in the NIH Animal Exposure Program (AEP)2, or an equivalent program. The NIH Occupational Medical Service (OMS) determines what is an NIH AEP equivalent program.  All injuries or exposures involving nonhuman primates, tissues, or waste must be reported to OMS immediately upon completion of wound care.

2 If individuals are animal caretakers, technicians, or other facility staff, their immediate supervisor (IS) will maintain a record of their enrollment in AEP (or equivalent program). If the individual is a researcher, their IC Animal Care and Use Committee (ACUC) coordinator will maintain a record of their enrollment in AEP (or equivalent program).

1. ​​​The Principal Investigator (PI) or Immediate Supervisor (IS) is responsible for:
   1. Completing both components of the “Working Safely with Nonhuman Primates” course annually if NHPs are listed in their animal study proposals.
   2. Ensuring their research staff members working with NHPs comply with the provisions of this Policy Manual (PM) and any other special requirements or procedures specific to the facility within which they are conducting NHP procedures. In addition, the PI/IS will take corrective action for failure to comply with the provisions of this policy.
   3. Providing copies of all NHP training documentation to DOHS during routine safety surveys, during incident investigations involving NHP-related exposures, injuries or illnesses if requested.
   4. Providing copies of all NHP training documentation to their IC ACUC if requested.
   5. Describe all NHP awake procedures or provide the Standard Operating Procedure (SOP) number in the Animal Study Proposal(s) (to be reviewed and approved by the ACUC).
   6. Ensuring a trainee’s competency in conduct of awake NHP procedures is appropriate and fully documented before allowing a trainee to perform these procedures independently.
   7. Ensuring all personnel using pole and collar devices to move NHPs are briefed on the appropriate technique annually.
   8. Ensuring research staff members receive training that direct hand to mouth feeding of Old World NHPs is prohibited. Please also refer to NHP user section 2f.
   9. Ensuring trainees who have not performed NHP procedures and/or NHP awake procedures within the past 6 months document their re-take and document the initial NHP safety awareness and if applicable, the NHP awake procedures training before working with NHPs.
2. The NHP user is responsible for:
   1. Adhering to all provisions of this Policy Manual.
   2. Completing the annual NHP safety awareness training.
   3. Completing any additional training that their PI/IS has established for them prior to attempting unsupervised, procedures on a NHP. 
   4. Documenting competency in conduct of NHP awake procedures as part of the ASP Training and Experience form. If additional training is needed, ensure this is documented as well.
   5. Adhering to the requirement that the presentation of food, fluids, or research test agents to the mouths of Old World NHPs may only be conducted indirectly, e.g., using tongs, a utensil or research apparatuses.
3. NHP Safety Trainers are responsible for:
   1. Conducting one or both components of the safety awareness training course: “Working Safely with NHPs” annually for NHP users within their ICs.
   2. Ensuring documentation of trainees’ completion of the “Working Safely with NHPs” course is maintained by NIH.
4. The OACU/OIR is responsible for:
   1. Developing and managing the materials for NIH IRP NHP safety training program.
   2. Administering the Nonhuman Primate Train-the-Trainer Course to IC level NHP Safety Trainers and providing NHP Safety Trainers with the information and an outline to administer the “Working Safely with Nonhuman Primates” course.
   3. Ensuring training addresses safe and humane NHP work practices, adheres to DOHS safety standards, and addresses DOHS-identified accident report trends of potential problem areas.
5. The DOHS is responsible for:
   1. Providing general guidance on the selection and use of personal protective equipment for animal facilities, other areas that support animal research and in areas where NHPs are maintained and used. Specific PPE guidance shall also be provided to PIs and facility managers when NHP activities involve working with infectious diseases, hazardous chemicals, etc.
   2. Selecting and approving occupationally required respirators if needed for NHP care and use.
   3. Periodically reviewing NHP safety training documentation as part of their safety inspections and reviewing NHP safety training documentation as part of an incident investigation involving a NHP-related injury or illness.
   4. Regularly reviewing NHP-related human injury and illness occupational reports and making accident information available to the OACU.
   5. Providing appropriate medical support services for animal researchers including those researchers working with NHPs (e.g., pre-placement medical evaluations; risk assessment; AEP enrollment; care for work related injuries, exposures and illnesses; and Worker’s Compensation.)
6. The IC ACUC is responsible for:
   1. Ensuring all individuals working with NHPs receive annual safety awareness training by completing the “Working Safely with Nonhuman Primates” course as outlined in section F2.
   2. Ensuring all individuals at the IC and/or facility level who conduct one or both portions of the “Working Safely with Nonhuman Primates” training course take the required annual “Nonhuman Primate Train-the-Trainer” course provided by the Office of Animal Care and Use (OACU) as outlined in section F2.
   3. Ensuring that all personnel using pole and collar devices to move NHPs are briefed on the appropriate technique annually.
   4. Ensuring those individuals working with awake NHPs receive competency assessment and additional training (if needed).
7. Animal program staff members are responsible for:
   1. Ensuring all NHP awake procedures are described and delineated in facility SOPs.
   2. Documenting all training and experience related to performance of NHP awake procedures in the facility training records.
8. Animal Facility Management is responsible for:
   1. Providing and maintaining wound flushing equipment, NHP Bite, Scratch, Splash, Exposure (BSSE) kits, and response instruction charts as described in the NHP BSSE Guidelines.
   2. Completing the Macaque Health Report form located in the NHP Bite, Scratch, Splash, Exposure (BSSE) kit for submission to OMS following a macaque-related accident, illness, or exposure.
   3. Obtaining clinical samples from NHPs that are involved in personnel-related accidents, illnesses, or exposures—if requested by OMS.

1. Personnel Restrictions:
   1. Transient Visitors and all personnel who have not been appropriately trained must be accompanied by a responsible facility staff member who is knowledgeable in the behavior and handling of NHPs.
   2. Individuals less than 16 years of age may not be present in NHP holding rooms or where procedures or research activities involving NHPs or NHP blood, body fluids and tissues are ongoing. Minors are not permitted in nonhuman primate holding rooms or areas where procedures with awake nonhuman primates are conducted. Additionally, they may not work with human and/or nonhuman primate blood, body fluids and tissues.
   3. Transient Visitors must meet the medical testing requirements established by the facility Animal Program Director prior to entering a NHP animal facility or room as noted in DOHS memorandum: Medical Clearance of Transient Visitors into NIH Animal Facilities.  
2. Training:
   1. All personnel working directly with NHPs or regularly entering a facility containing NHPs shall complete the “Working Safely with NHPs” safety awareness training course and retake the course annually prior to unsupervised entry. Personnel interacting with awake NHPs may also need additional training3 in approaching and handling NHPs. Certification is ensured by the Principal Investigator or immediate supervisor that a basic level of competency in performing awake procedures has been achieved. See PI/IS responsibilities paragraph in E1.
   2. Personnel handling unfixed NHP tissues (i.e., no live animals) must complete both the Working Safely with NHPs, and Working Safely with HIV and Other Bloodborne Pathogens for Non-Hospital Personnel courses prior to working with the tissues; and thereafter annually complete the Working Safely with HIV and Other Bloodborne Pathogens for Non-Hospital Personnel course.
   3. Transient Visitors who do not directly handle NHPs and/or infrequently enter a facility containing NHPs, must complete the second component of the “Working Safely with NHPs” safety awareness training course annually as described below in F.2.d. ii. The second component of the course addresses the facility’s PPE requirements, location of Bite, Scratch, Splash, Exposure kits, wound flushing, and eyewash stations as described in the NHP BSSE Guidelines.
   4. The safety awareness training course: “Working Safely with NHPs” (NHP Course) consists of two components:
      1. “Working Safely with NHPs” video/CD, quiz, and review of pertinent NIH Policy Manuals.
         • Trainers will maintain training completion records for their IC.
      2. The second component is a review of facility PPE requirements and location of Bite, Scratch, Splash, Exposure kits and eyewash stations.
         • Personnel entering multiple facilities where they work directly with NHPs or enter NHP facilities without supervision, must complete the second component of the training for each facility.
      3. Upon completion of both components of the “Working Safely with NHPs” course, the NHP Safety Trainer will document the trainee course completion either at the IC level or, if available, in a database maintained by the OACU.
      4. NHP Safety Trainers who wish to provide “Working Safely with NHPs” IC level training must take the “Nonhuman Primate Train-the-Trainer” course annually. This course is provided by the Office of Animal Care and Use (OACU). OACU will document completion of this training.
3. Personal Protective Equipment:
   1. All individuals entering a NHP room must wear appropriate personal protective clothing and equipment which meets or exceeds the guidance established by the NIH Animal Research Advisory Committee (ARAC): Guidelines for Personnel Protection in Animal Facilities.
   2. Individuals participating in animal study proposals (ASP) which involve additional safety hazards such as infectious diseases or hazardous chemicals must consult the DOHS safety recommendations as written in the IC-approved ASP(s) or provided by a DOHS Safety Specialist.
4. Animal Exposure Program:
   1. All persons having direct contact with NHPs and their tissues or body fluids must participate in the NIH Animal Exposure Program (AEP) provided by OMS or an equivalent program provided by the contractor.
   2. Transient Visitors are not required to participate in the AEP; however, prior to entering NHP holding and procedure areas, Transient Visitors will be required to comply with the facility health screening requirements) set by the facility’s Animal Program Director (e.g., provide proof of: TB testing, measles vaccination, measles titer or measles infection history.
5. Employee Wound Care and Reporting Procedures for All NHP-related Injuries/Illnesses/Exposures:
   1. ALL personnel involved in injuries and exposures involving NHPs, NHP wastes, unfixed NHP tissues or body fluids, or potentially contaminated equipment must immediately (within five minutes) initiate wound or mucous membrane first aid.
      1. Contaminated skin and wounds should be thoroughly scrubbed and flushed continuously for 15 minutes with clean running water or normal saline solution, a sponge, and a cleansing agent such as povidone-iodine or chlorhexidine, provided on-site in the NHP bite/scratch (BSSE) kit.
      2. Contaminated eyes and mucous membranes should be irrigated at an eyewash station for 15 minutes using normal saline solution or clean running water.
   2. After initial wound or mucous membrane care is completed and appropriate medical treatment is sought, the individual must report the incident/exposure to their PI/IS and the animal facility management where the NHP is housed.
   3. Another individual may contact OMS, the animal facility management, and the individual’s PI/IS to report the incident while the injured person is receiving first aid or seeking medical attention. 
6. Employee Wound Care and Reporting Procedures for Macaque-related Injuries/Illnesses/Exposures:
   1. General wound care guidance for NHP bite, scratch or splash exposures and reporting requirements are found in the NHP BSSE Guidelines.
   2. OMS must be contacted as soon as possible after the occupational exposure regarding any additional treatment and/or follow-up care instructions.
      1. Ask to speak with the OMS provider-on-duty, and state: “I have had a nonhuman primate-related injury or incident.” Notify the Bethesda Main Campus Clinic regardless of geographic location or NIH research campus.
      2. Call 301-496-4411 (Bethesda Main Campus Clinic), 7:30 am – 5:00 pm ET, Monday – Friday
      3. After-hours call 301-496-1211 (NIH Operator), 5:00 pm – 7:30 am ET, Monday – Friday, and on weekends & holidays.
      4. When possible, a co-worker should make the call to OMS while first aid is performed. Individuals unable to call OMS before completing scrubbing/flushing must call from their worksite immediately after scrubbing/flushing.
      5. If instructed by the OMS provider, take the prescribed dose of valacyclovir orally, which is located in a sealed bag within the BSSE Kit or other pre-determined, easily accessible location.
      6. After completing first aid and calling OMS (numbers above, including after hours), immediately proceed to the closest OMS clinic for further evaluation, unless instructed otherwise by the OMS provider.
   3. The management staff for each NHP facility or laboratory using unpreserved tissues is responsible for maintaining adequately stocked Bite, Scratch, Splash, Exposure kits. A list of the location of each kit will be provided to the Animal Program Director and the IC Safety Committee annually for their review and approval. An updated list for each facility must be sent annually to the ACUC of the lead IC, OACU, and the Animal Program Safety Manager (DOHS), for their information.
   4. The Bite, Scratch, Splash, Exposure kits must be located in an easily accessible area. Changes in locations and/or instructions related to these kits must be communicated to the NHP Safety Trainer and subsequently forwarded to all prior trained individuals.
   5. The facility NHP Safety Trainers are responsible for showing the location and contents of the Bite, Scratch, Splash, Exposure kits and the locations of the eyewash stations to the research and animal care staffs during the second component of the “Working Safely with NHPs” training.
7. Macaque Unfixed Tissue/Body Fluid Users:
   1. Macaque monkeys and their tissues and body fluids are potentially infected with Herpes B Virus/Macacine alphaherpesvirus 1. To ensure safety and reduce injury, the below requirements must be completed:
      1. Individuals at the NIH who will in any manner handle unfixed NHP tissues, blood, or body fluids must have documentation indicating they are current with these mandatory DOHS safety training courses:
         • Working Safely with HIV and Other Bloodborne Pathogens for Non-Hospital Personnel for first time attendees, or
         • The annual Bloodborne Pathogen Refresher Course (Online)
         • The one time “Working Safely with NHPs” training before beginning work with unfixed tissues.
8. Institutional Biosafety Committee Registration for Macaque Unfixed Tissue/Body Fluid Users
   1. NIH IBC Registration Determinations and Exemptions
      1. Principal investigators (PIs) handling unfixed tissues, blood or body fluids from macaques (Rhesus, Pigtail, and Cynomolgus monkeys) are required to register and receive IBC approval their work and the experimental use of these materials with the NIH Institutional Biosafety Committee (IBC) via PI-DASHBOARD and receive IBC approval prior to handling macaque unfixed tissues, blood or body fluids. Research staff working with unfixed tissues, blood, or body fluids must be listed on the registration.
      2. The NIH-IBC registration will incorporate/identify all associate investigators, technicians, and affiliated lab personnel who will in any manner handle the macaque tissues, blood, or body fluids regardless of their status on a given Animal Study Proposal.
      3. Changes to experimental work with unfixed macaque tissues, blood or body fluids already registered (and related to an already-approved registration) must be submitted as an amendment to the existing NIH-IBC registration. Amendments are also required to update changes in personnel and location-of-work.
      4. Macaque monkey tissues, blood or body fluids fixed and/or preserved in formalin, glutaraldehyde, or paraformaldehyde (and using well-documented, evidence-based methods shown to be effective in rendering samples non-infectious) are not considered ‘unfixed’ and do not require registration with the PI-DASHBOARD.
      5. Work with unfixed tissue, blood, or body fluids derived from New World NHP species (e.g., squirrel monkeys, owl monkeys, Cebus monkeys, tamarins, marmosets, etc.) does not require an IBC registration.
      6. Veterinary care procedures performed by the veterinary or animal care staff within an animal research facility are exempt from NIH-IBC registration.
   2. Transfer of NHP Unfixed Tissue/Body Fluid
      1. If unfixed macaque NHP tissues, blood or body fluids are provided by a PI to another NIH laboratory or individual working outside of an ACUC-approved NHP animal research facility:
         • The receiving PI must hold an NIH IBC-approved registration to receive the material.
         • The NIH-IBC registration must be established prior to the transfer and receipt of the samples.
         • The transferring PI is responsible for ensuring the receiving PI holds an NIH IBC-approved registration for work with this material in NIH laboratories outside of ACUC-approved NHP animal research facilities.
      2. If unfixed macaque NHP tissues, blood or body fluids are provided by a PI to another laboratory or individual outside of the NIH, the transferring PI is responsible for ensuring that the receiving laboratory or individual:
         • Knows the human health related risks associated with the handling of unfixed macaque NHP tissues blood or body fluids, and
         • Understands their responsibility for compliance with their institution’s policies and procedures relating to the handling of potentially infectious material.
      3. Once a sample is appropriately transferred to another laboratory (i.e., research, clinical, pathology, etc.), the receiving PI and laboratory is responsible for the subsequent disposition of the transferred material in accordance with this policy.
9. Compliance:
   1. All NIH employees, contract personnel and other personnel working directly with NHPs or regularly entering a facility containing NHPs shall comply with procedures set forth in this Policy Manual.
   2. Continued failure to comply with requirements set forth in this policy shall be reported to the Scientific Director and/or Institute Director and may result in suspension of the privilege to use NHPs in research protocols or other disciplinary action.
   3. The Institutional Official shall be informed of such infractions and may impose additional disciplinary actions.

3 This training is performed at the IC and/or facility level and must be arranged through the facility manager or veterinarian. Detailed description of the expectations are in the NHP BSSE Guidelines.

All records pertaining to this chapter must be retained and disposed of under the authority of NIH Manual 1743, "Managing Federal Records," Appendix 4, Records Management Resources. These records must be maintained in accordance with current NIH Records Management and Federal guidelines. Contact your IC Records Liaison or the NIH Records Officer for additional information

The purpose of this manual is to establish requirements for training, supervision, compliance, personal protective equipment, medical surveillance, accident reporting, and wound care with the intent to minimize the overall number of accidents and injuries sustained by NIH employees, Special Volunteers, and Transient Visitors who work with nonhuman primates or enter nonhuman primate rooms.

1. Office Responsible for Reviewing Internal Controls Relative to this Chapter: Office of Animal Care and Use and the Office of Intramural Research.
2. Frequency of Review (in years): Ongoing with formal reports presented to the Animal Research Advisory Committee (ARAC) semiannually, annually, and triennially as described below.
3. Method of Review:
   1. The procedures implemented by this chapter receive an ongoing review by the Office of Animal Care and Use via their interface with all IC-ACUC’s on a continuous basis. Any significant changes in training policies or animal procedures are noted and acted upon as needed rather than at a specified time.
   2. Semi-annually the IC-ACUC’s perform a complete review of their animal care programs, a component of which is a review of the adequacy of IC training and experience. These semi-annual reports are filed with OACU. The OACU staff members review these reports, prior to their submission for review by the DDIR, and the OACU Director then provides a consolidated report to the ARAC regarding trends, concerns, etc. that affect the Intramural Animal Care and Use Program (ACUP).
   3. Annually the Division of Occupational Health and Safety compiles a report of bite and scratch injuries related to work with nonhuman primates and presents this to the NIH Occupational Safety and Health Committee and the ARAC. This report provides a basis for discussion of trends seen within this work arena and provides an avenue for both the NIH as well as the Intramural ACUC’s to develop new guidance if concerns exist.
   4. Triennially, the Intramural ACU program is visited by their accrediting organization, the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). Training and experience with NHPs is a part of AAALAC’s extensive review of the NIH. AAALAC provides a report of their findings to NIH which in turn is presented to the ARAC for deliberation and resolution.
   5. The Intramural Research Program (IRP) must make annual reports to both the United States Department of Agriculture and the NIH Office of Laboratory Animal Welfare (OLAW.) These agencies have regulatory authorities over the NIH IRP Animal Care and Use program. Per the PHS Policy, instances of significant noncompliance are required to be reported to OLAW.
   6. In addition, the IC Directors or Scientific Directors participate in the Annual Intramural Self-Assessment of Management Controls, through completion of a set of comprehensive checklists of questions, several of which address concerns covered by this chapter. This process is managed by the Office of Intramural Research.
4. Review Reports are sent to: the Deputy Director for Intramural Research and the Deputy Director for Management.