citation_inspection

At the south farm, a goat was observed to jump up onto the ledge of the concrete foundation and move from pen 4 over to pen 5 and then back to pen 4 again. There was a panel up on the ledge in place to prevent this, however the goat could pass between the vertical supports of the panel. Also, the panel had some free ends of wire that if bent out could become sharp points exposed to any goat that climbs up on the concrete ledge. Lack of proper containment and exposure to sharp points could lead to injury or other adverse events. The facility must ensure that enclosures are structurally sound and maintained in good repair to contain the animals and protect them from injury. Correct by October 5, 2016. This inspection and exit interview were conducted with facility representatives on 9/26 thru 9/27/2016.

One expired bottle of Isoflourane (expiration date 20 Aug 2014) was found on a shelf in the procedure room. The procedure utilizing this anesthetic agent had been removed from the protocol in May 2017. Expired medications may have compromised efficacy and potency and use of such does not constitute adequate veterinary care. The institution needs to ensure that medications are not being used past their expiration date. Expired bottle was disposed of at the end of the inspection. This inspection and exit interview were conducted with facility representative.

In August 2015, a cynomolgus macaque placed under anesthesia for a study procedure was observed to have a low body temperature. In order to normalize the animal's core temperature during the procedure, a staff member was directed by a veterinarian to use a hot air source; however, the nozzle of this hot air source was inappropriately placed in a location which subsequently led to thermal injuries and later, euthanasia. It is the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform necessary or directed duties. This responsibility shall be fulfilled in part through the provision of training and appropriate instruction to those personnel. Corrective measures were taken, including but not limited to, retraining of all involved staff and observation of techniques by veterinary staff. This item has been corrected by the facility.

A review of facility records for the marmoset (microchip # 004-004-103) which died on 23 Dec 2015 following a procedure performed on 21 Dec 2015 found that the PI did not follow the approved protocol in regards to IV catheter placement and IV fluid support as well as amounts and routes of anesthetic and paralytic drugs used during the procedure. The PI did not follow the instructions of the veterinarian and the procedure continued 10 hours rather than the veterinarian recommended 2-3 hours. The animal subsequently died ~33 hours post procedure. The research facility must ensure that the attending veterinarian has the appropriate authority to ensure adequate veterinary care is provided and to oversee the adequacy of other aspects of animal care and use. Failure to follow approved protocols and veterinary recommendations can result in outcomes such as occurred with this animal. Prior to the inspection, changes to the protocol were made to incorporate corrective measures, and new procedures were put in place to prevent a recurrence. This inspection and exit interview were conducted with facility representatives. Additional Inspectors Secor Thomas, Veterinary Medical Officer

Two marmosets (male 601 858 271, female 844 827 014), were found dead entrapped in their nest box on August 12, 2020 at 8:04 am during the morning observation . At some point after the afternoon observation at 2:38 pm on August 11, the 2 animals entered their nest box in their home cage and the door to the nest box closed so they could not get out. The animals were entrapped in the box for ~18 hours. The cause of death was overheating and distress. Primary enclosures must be constructed and maintained so that they protect the nonhuman primate from injury and harm. All the doors on the nest boxes in marmoset caging were removed prior to inspection. Corrected prior to inspection.

On January 17, 2020, Eight (8) rabbits (ID 20-101,-102,-103,-104,-105,-106,-109,-110) underwent a 2nd surgery to implant a supplemental lens after a first surgery was conducted 14 days earlier. The second surgery was not included in the IACUC approved protocol. All proposed and approved animal use activities must include a complete description of the proposed use of the animals. Incomplete descriptions of all procedures do not allow the IACUC to fully assess the protocol to ensure the safe and humane use of the animals. The protocol was amended and the renewal includes the second surgery. Corrected by the time of inspection. This inspection and exit interview were conducted with facility representatives. End Section

Two IACUC approved protocols did not have an alternative search for procedures that would cause more than momentary or slight pain and distress to the animals. **08092013EH00009-02 involving pika was designated as a "Category D" which includes procedures for which analgesia, sedation, tranquilization, and/or anesthesia are provided to relieve anticipated pain and/or distress. There was no search for alternatives for the procedures for which anesthesia was to be used in the animals. **20150205SF00139-01 involving sheep had a search for alternatives to painful and/or distressful procedures that had the keywords "indwelling catheters and alternatives". Other procedures proposed (blood pressure manipulations) would be potentially painful and distressful but no search for alternatives to these methods were made by the principal investigator. Alternatives to procedures that may cause more than momentary or slight pain or distress to the animals must be considered by the principal investigator to ensure that animals are being used in research in the most humane manner to meet scientific goals. Whether alternatives exist or can be used by the principal investigator is not the deciding factor in conducting an appropriate search. The IACUC's review of activities involving animals shall ensure that the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g., the Animal Welfare Information Center, used to determine that alternatives were not available. To be corrected by 5/31/2015. Inspection and exit interview conducted with facility representatives and AC VMO, Tracy Thompson, DVM.

***Facility personnel did not perform adequate daily observations of two sheep, ID #7070 and #8020, by failing to communicate their health conditions to the attending veterinarian. Written daily observations provided by the facility indicate that on 06/03/18 sheep #8020 “had no interest in food.” On 06/09/18, sheep #8020 “wasn’t eating and was laying down.” On 06/10/18 he was treated for urinary calculi, however a facility representative stated that the sheep had not been examined by or diagnosed by a veterinarian. On 06/11/18, he was observed to be down and "didn't get up this morning." At the 1PM observation later that day, records indicate that “8020 died due to complications from urinary calculi.” Written daily observations provided by the facility indicate that from 06/04/18-06/25/18, ewe #7070 had been vomiting almost on a daily basis. A facility representative informed the APHIS inspector that he had been feeding her alfalfa pellets separately from the herd, as she was very thin and her teeth were worn down. He stated that she had not been seen by a veterinarian recently. On inspection, APHIS inspector observed that ewe #7070 was thin, and her spine and hip bones were protruding. The attending veterinarian stated that neither he nor the other veterinarian on staff had examined either of these sheep. Adequate daily observation of all animals and direct communication with the attending veterinarian is critical to ensure that conditions that can adversely affect health and well-being can be diagnosed and treated in a timely manner. Injuries, diseases, and medical conditions that are not treated properly (as directed by a veterinarian) may be worsened and can lead to prolonged suffering. Each research facility shall establish and maintain programs of adequate veterinary care that include daily observations of all animals to assess their health and well-being; provided, however, that daily observation of animals may be accomplished by someone other than the attending veterinarian; and provided further, that a mechanism of direct and frequent communication is required so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian. To be corrected from this date forward. This inspection and exit interview were conducted with facility representatives.

In the enclosure housing 8 sheep at the Multipurpose Building, there was a wooden shelter with a broken side. The broken edges were jagged and there were protruding wires with sharp points. These jagged edges and wires could cause injury to the sheep living in this enclosure. All housing facilities shall be structurally sound and maintained in good repair to protect the animals from injury. TO BE CORRECTED BY 28 AUGUST 2020.

At the Red Buttes animal facility, an enclosure housing chipmunks had a large amount of overgrown vegetation surrounding the enclosure. On two sides of the enclosure, the vegetation completely obscured the enclosure walls from the outside. In order to see into the enclosure, the inspector had to stand on a gate due to the height and density of the weeds. This amount of overgrowth does not allow for proper visualization of the enclosure walls to ensure that it is in good repair nor does it allow easy visualization of the animals within the enclosure. Overgrown vegetation can also be an area for pests or predators to live in, which could lead to disease or injury of the chipmunks within. The premises must be kept clear of weeds and in good repair in order to protect the animals from injury and to facilitate proper husbandry practices. TO BE CORRECTED BY 28 AUGUST 2020. This inspection was conducted on 8/18/2020 and the exit interview was conducted on 8/19/2020 with facility representatives.

Several expired or improperly labeled medications were found during the inspection: **A box of Bordetella bronchiseptica Intranasal vaccines, which expired 05 Aug 2013, were found in the refrigerator with the current supply of vaccines and other refrigerated medications. **A syringe that had been labeled with pen with what appeared to be "Buprenorphine" didn't have an expiration date or was so difficult to read that it could not be determined. **Two bottles of hydrogen peroxide were found to be expired as of 08/2014. **A bottle of injectable Banamine (exp. 7/2014) was comingled with current medications in the lock box in the large animal barn and the Drug Expiration Monthly Check Form on this box showed it checked by a veterinarian on 8/21/14 and 9/2/14. **The refrigerated drug supply in the large animal barn had an unlabeled syringe with a pink fluid, a box of Tetanus Antitoxin vials that expired 15 Jul 2014, Intervet Equine Vaccination vial (exp. 15 Aug 2014), and 2 vials of Tetanus Toxoid (1 exp. 23 Aug 14, 1 exp 19 Jul 14). The Drug Expiration Monthly Check Form for this refrigerator had not been marked as being checked since 5/14. The facility has a program to check drug stores for medical materials that are expired to remove them from current drug storage but does not appear to be adequate to detect and remove expired medical materials from drug storage areas to prevent their use which would not be an appropriate method to prevent, control, and treat diseases and injuries since the expected results cannot be guaranteed and the animals may experience pain and distress due to mistreatment, unrelieved symptoms, or due to unexpected side effects. Each research facility shall establish and maintain programs of adequate veterinary care that include: the use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries.

A Basenji-mix dog named Hudson, ID# 982000362183995, was noted by the APHIS AC VMO to be holding his left hind foot up while in his primary enclosure. The dog was removed from the enclosure for examination and the left hind foot was found to be swollen and pink when compared to the right hind foot. The dog would bear weight on the foot but frequently held it up in the air and seemed tender when the foot was touched. No one had noted this problem before the APHIS AC VMO had identified the problem. The slatted floor in the primary enclosure had gaps that were wide enough to allow the toes of this dog and another adjacent Boston terrier dog's toes to pass down into the gaps, posing a risk of injury to the toes and feet. The facility does have rubber mats that can be placed in the primary enclosures to protect the dog's feet but had not put mats in these two enclosures. Hudson's left hind foot appears to have been injured by the gaps in the slatted floor. Primary enclosures must be constructed and maintained so that they:have floors that are constructed in a manner that protects the dogs' and cats' feet and legs from injury, and that, if of mesh or slatted construction, do not allow the dogs' and cats' feet to pass through any openings in the floor. To be corrected by 9/16/2014.

***During the inspection, it was noted that the facility was not following treatment directions provided by the veterinarian. A treatment sheet for a 6 year old, neutered, hound mix named Bubba indicated that he had been prescribed Rimadyl to be given orally twice a day beginning on 09/22/17 and ending when the medication had finished. On 09/23/17 the treatment sheet indicated that Bubba had only received the medication once that day. It was not until the time of inspection that facility staff realized that the treatment plan had not been properly adhered to. Injuries and diseases that are not treated properly (as directed by a veterinarian) may be painful and can lead to prolonged suffering, infection, and other veterinary care health problems. The facility must use appropriate methods to prevent, control, diagnose, and treat diseases and injuries. Any change by the facility staff or students to prescribed veterinary treatments should be discussed with and approved by the veterinarian. To be corrected by October 4, 2017 This inspection was conducted with the Veterinary Technology Program Director and the exit interview was conducted with the program director and two facility representatives.

A responsible adult was not available to accompany APHIS Officials during the inspection process at 11:00-11:30am on 11-AUG-21. Upon arriving at the facility, the inspector called all available numbers and left voicemails. The inspector also knocked on the door of the facility multiple times with no answer. After no response from the registrant for 30 minutes, the inspector left. End Section

A ram at a sheep flock that is used under a holding protocol and a teaching protocol approved by the facility's Institutional Animal Care and Use Committee was found to be unable to stand on January 24, 2014. The herdsman who discovered the animal in this condition monitored and treated the animal for three days without consulting the attending veterinarian. The animal did not improve, and was subsequently euthanized. Animals should be observed on a daily basis to assess their well-being, and any problems should be promptly communicated to the attending veterinarian, so that appropriate steps can be taken to address health problems. In this case the animal clearly needed prompt veterinary attention, and it was not received. Failure to communicate problems and provide adequate care can result in unnecessary suffering. The facility recognized this failure, reported the event, and has taken appropriate action to correct the problem with the personnel involved. An exit interview was conducted on 9/21/15 with facility representatives.

At the time of inspection it was discovered that on 12/4/14 a dog was given Ketamine, an anesthetic drug, and the vial of Ketamine used had an expiration date of November, 2014 (vial # 5 in drug log). Additionally, the anesthesia machines at the facility were all overdue for service - with "next service due" dates 12/14, 9/13, and 5/15. The facility should ensure that appropriate methods are employed when administering anesthesia, and this includes ensuring that drugs are not expired, and that anesthesia machines are maintained in optimal condition. Failure to maintain such standards could result in adverse effects for animals undergoing procedures at the facility. Steps should be taken to remedy these problems and ensure that they do not recur. Use of expired drugs to be corrected immediately, and service on anesthesia machines to be completed by 10/20/15. An exit interview was conducted with the Program Director (9/17/15) and the IACUC representatives (9/21/15).

The facility is comprised of enclosures and a roof that are in critical disrepair. Some gates have openings with protruding wires, feeders are falling apart, with exposed nails protruding, and the roof where the ewes are is actively shedding corroded pieces of corrugated metal, with broken pieces on the ground, and others threatening to fall from above. These elements have sharp edges and falling pieces which present a risk of injury to the animals. The gates and fencing in disrepair also present an escape risk. The facility must be constructed of such material and of such strength as appropriate for the animals involved. The indoor and outdoor housing facilities shall be structurally sound and shall be maintained in good repair to protect the animals from injury and to contain the animals. The facility should make necessary repairs or relocate the animals.

The USDA Annual Report filed for Fiscal Year 2021 incorrectly accounts for the pigs. The number of pigs used in research/teaching was stated in column C (no pain, distress or use of pain-relieving drugs) instead of the correct column D (accompanying pain or distress to the animals for which appropriate anesthetic, analgesic or tranquilizing drugs were used). The pigs were used in surgical procedures. Properly identifying animals used in research on the annual report is necessary to inform the Institutional Official and USDA Animal Care of the scope and extent of the animal use at the facility. The 2021 annual report needs to be amended and resubmitted to USDA Animal Care with all animal use data accurately included. Correct by July 31, 2022. This inspection and exit interview were conducted with the IACUC representative. End Section

A responsible adult was not available to accompany APHIS Officials during the inspection process at 1330 on 28Aug2023. Email attempts to contact local and regional personnel were not answered within allotted 30 minute wait period. Inspector departed airport at 1415. End Section

At the cargo office for General Aviation Terminal, two cats had been accepted for transport on waybill # 173-07836920, on a flight bound for Honolulu. The shipment date on the waybill was 04/10/2023. APHIS form 7001 was signed by the issuing veterinarian on 3/29/2023. There are twelve (12) days between the veterinarian health certificate and the waybill. Intermediate handlers must ensure that the Health Certificate issued by a licensed veterinarian is in accordance with paragraph (a) referencing article (2.78 (a)(1) and is issued on a specified date which shall not be more than 10 days from the initial issuance of the Health Certificate This inspection and exit interview were conducted in the cargo area with the ground handler. Additional Inspectors: KATHARINE FRANK, VETERINARY MEDICAL OFFICER n

At the cargo office for General Aviation Terminal, two cats had been accepted for transport on waybill # 173-07836920, on a flight bound for Honolulu. The shipment date on the waybill was 04/10/2023. APHIS form 7001 was signed by the issuing veterinarian on 3/29/2023. There are twelve (12) days between the veterinarian health certificate and the waybill. Intermediate handlers must ensure that the Health Certificate issued by a licensed veterinarian is in accordance with paragraph (a) referencing article (2.78 (a)(1) and is issued on a specified date which shall not be more than 10 days from the initial issuance of the Health Certificate This inspection and exit interview were conducted in the cargo area with the cargo handler. Additional Inspectors: KATHARINE FRANK, VETERINARY MEDICAL OFFICER n

Proposals to conduct an activity on animals. 1. Review of Protocol # 100598-0116: There was a discrepancy noted between the monitoring procedures outlined in the IACUC approved protocol and the situation observed by the APHIS inspector at the time of the inspection. The protocol states that "Rabbits are monitored following anesthesia until alert....." but during the inspection the APHIS inspector observed a Rabbit in its primary enclosure that was unconscious and in lateral recumbency. No one was in the room with the Rabbit and its medical record indicated that the animal had received an injection of an anesthetic a little over 2 hours ago and an injection of an analgesic less than ½ hour ago; both of the medications had been administered by research personnel. Per this Section of the Regulations, a proposal for animal use must contain a description of the procedures designed to assure that any discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provisions for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate. Research personnel are expected to follow animal use procedures as they are described in the IACUC approved protocol. The IACUC needs to address the discrepancy identified for this ongoing IACUC approved research proposal. Correct by 8/21/14.

Training of personnel. 1. It was noted when GP #98 was examined during the inspection, that all of the animal(cid:25)'s toe nails were excessively long when compared to the length of the toe nails of the other 3 GPs housed in the same room. The animal moved normally and none of the toe nails were damaged. The GPs are regularly handled by facility personnel whenever the primary enclosures are changed and according to the room log, the enclosure of GP #98 has been changed 3 times per week for at least the past month. Per this Section of the Regulations, all personnel involved in animal care should be appropriately trained in the proper handling and care for the species of animals that they care for. The excessive length of the toe nails of GP #98 should have been recognized by facility personnel at the time of direct handling of the GP during routine cage changes and the toe nails trimmed accordingly. Excessively long nails can be associated with discomfort and can be prone to injury. Although this item was corrected by facility personnel during the inspection by trimming the long toe nails of GP #98, the Registrant needs to ensure that all personnel involved in animal care are familiar with the proper care and handling of the species of animals that they care for and are familiar with the normal physical and behavioral characteristics of those species so that any deviations from normal are promptly recognized and appropriately addressed. Correct by 5/22/15.

Cleaning of primary enclosures. 1. It was noted during the inspection that most of the corn cob bedding material inside the solid floor primary enclosure of GP #98 was very wet and there was a minimal amount of dry bedding material present compared to the other 3 primary enclosures in the room that each contained one GP. In addition the enclosure for GP #98 had a strong ammonia odor and an excessive amount of fecal material compared to the 3 other GP primary enclosures. The skin of the caudal aspect of the hock and metatarsal area of both rear legs of GP #98 was a deeper shade of pink compared to the skin of the other 3 GPs but there were not any clinical problems noted in the animal. Per this Section of the Regulations, GPs should be transferred to a clean enclosure whenever their primary enclosure become wet or soiled to a degree that might be uncomfortable or harmful to the health of the animal. Although this item was immediately corrected by facility personnel during the inspection by transferring GP #98 to a clean enclosure, the Registrant needs to ensure that facility personnel monitor the conditions of and change GP enclosures on a schedule that prevents the enclosures from becoming excessively soiled or wet. Correct from this date forward. NOTE - Inspection conducted 4/22/15 and 4/23/15. Exit interview held 4/23/15 on-site with facility representatives. *END OF REPORT*

Pertaining to IACUC approved Protocol 200794: The proposal for animal use was reviewed along with the medical records for 13 rabbits on the study. The following instances of the laboratory staff implementing significant changes in an ongoing activity without prior review and approval by the IACUC and instances of the laboratory staff not following the approved protocol were identified. The deviations with the IACUC approved protocol were identified by the IACUC during the November 2023 semi-annual facility inspection. 1. According to the research facility’s IACUC Acclimation Policy that investigators are to follow for all IACUC approved protocols, the acclimation period for all non-rodents is a minimum of 7 days. Review of facility records for the 6 rabbits delivered on 11/16/23 revealed that the 6 rabbits underwent a procedure requiring anesthesia on 11/17/23 (1 day of acclimation) and 1 rabbit delivered on 12/7/23 underwent a procedure requiring anesthesia on 12/12/23 (5 days of acclimation). Shortening of the acclimation period is a significant change regarding the use of animals in an ongoing activity that was not reviewed or approved by the IACUC committee. 2. Protocol states that two injections of the study compound will be administered to the rabbits. The first injection will be administered on study day 0 and the second injection of the study compound will be administered three days later on study day 3. Review of the medical record of rabbit #448 revealed that the study day 0 injection was administered on 12/29/23 and the second injection was administered 6 days later on 1/4/24. Doubling the time interval between study compound injections is a significant change regarding the use of animals in an ongoing activity that was not reviewed or approved by the IACUC committee. 3. Protocol states that the intra-articular injection will be performed under general anesthesia (acepromazine followed by inhalant agent). There was no documentation noted in the review of the medical records of 10 animals that the inhalant agent was administered during the injections as described in the approved protocol. 4. Protocol states that laboratory staff will monitor the rabbits “5 days per week until the prescribed study endpoint” following the intra-articular injections and following the major operative procedure. There was no documentation noted in the review of the medical records of at least 10 animals that the monitoring of the animals was performed as described in the approved protocol. 5. Protocol states that rabbits undergoing a major operative procedure will receive antibiotics for 3 days post-operatively. There was no documentation noted in the review of the medical records of 5 animals that underwent surgery that antibiotics were administered as described in the approved protocol. 6. Protocol states that acepromazine will be administered prior to procedures either as the sole agent or in addition to an inhalant agent, and the protocol includes an approved range for the dose. The dose of acepromazine administered to the rabbits was not documented in the medical records and it could not be determined if the dose of the medication was as described in the approved protocol. 7. Protocol states that “no more than 10 ml of blood at each bleeding”. The volume of blood taken was not documented in the medical records for the majority of the blood draws and it could not be determined if the volume of blood taken was as described in the approved protocol. Per this Section, with respect to activities involving animals, the IACUC shall review and approve, require modifications to secure approval, or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities prior to implementation by the investigator. Principal investigators are to follow the IACUC approved proposals and any proposed changes shall be reviewed and approved by the IACUC prior to implementation. The IACUC needs to address the deviations with the IACUC approved protocol that were identified for this proposal for animal use and ensure that all significant changes regarding the care and use of animals in ongoing activities are reviewed and approved prior to implementation. Correct by 3/1/24. This inspection and exit briefing were conducted with facility representatives. *END OF REPORT* n

Report to the Institutional Official. 1. The IACUC did not update the reports to the Institutional Official at least once every six months as required per this Section of the Regulations. The IACUC did complete the semi-annual reviews of the research facility's program for humane care and use of animals and did complete the semi-annual inspections of the animal facilities on 10/15/13, 4/22/14, and 10/1/14. However, the IACUC has not prepared a report to the Institutional Official for any of the semi-annual reviews that were completed on those 3 dates. The most recent semi-annual report prepared by the IACUC that was submitted to the Institutional Official was dated 4/22/13 for the semi-annual evaluations completed by the IACUC in April 2013. Per this Section of the Regulations, the IACUC shall evaluate the program for humane care and use of animals and inspect the animal facilities semi-annually and then submit a report to the Institutional Official. The reports shall be updated at least once every six months upon completion of the required semi-annual evaluations and must contain any minority views. In addition, the reports shall be reviewed and signed by a majority of the IACUC members and shall be maintained by the research facility and made available to APHIS for inspection. The IACUC needs to prepare reports for the semi-annual evaluations of the program for humane care and use of animals and the semi-annual animal facility inspections that were conducted by the IACUC on 10/15/13, 4/22/14, and 10/1/14 and the reports need to be submitted to the Institutional Official. Correct by 4/10/15.

IACUC Functions. 1. The IACUC has not conducted an evaluation of the research facility's program for humane care and use of animals and has not inspected the research facility's animal facilities at least once every six months as required. The date of the last evaluation of the program and inspection of the animal facilities was 10/1/14. As of the date of today's inspection, it has been almost 7 1/2 months since the IACUC completed the last evaluations and it was also noted that the IACUC had not yet scheduled a date to conduct the required evaluations of the program and animal facilities. Per this Section of the Regulations, the IACUC is responsible for conducting the semi-annual evaluations of the program for humane use and inspection of the animal facilities. Completion of these required evaluations by the IACUC is important to assess both the program for animal use and the condition of the animal facilities to evaluate and ensure that the research facility is adhering to the standards and regulations specified under the Act. NOTE - This was a focused inspection based on the non-compliant items identified during the last inspection. NOTE - Exit interview held 5/12/15 on-site with facility representative. Report delivered by e-mail 5/13/15. *END OF REPORT*

There was no one available during business hours to allow APHIS Officials to enter and inspect the facilities, property, records, and animals on29-JAN-20 at 1:15 PM. The inspector arrived on campus at 1:15 PM on 1/29/20 to conduct an inspection but the individual authorized to accompany the inspector was not in his/her office. The inspector tried to contact him/her by text messages and waited for almost 60 minutes before leaving. An AWA compliance inspection could not be conducted because there was no other authorized facility representative available to accompany the inspector. Unannounced inspections to determine compliance with the provisions of the AWA are required to assess the facility. Correct from this date forward by providing inspector with alternate points of contact and schedule of availability. NOTE - This is the FIRST attempted inspection. Report delivered by e-mail 1/30/20.

Watering. 1. At the end of May 2014, two single-housed Peromyscus mice were found dead in their enclosures several days following complete cage change. It was later determined that the Peromyscus died as a result of employee error when their enclosures were placed onto an automatic water-equipped rack incorrectly and as a result the animals did not have access to any water. Per this Section of the Regulations, water must be provided to animals as often as necessary for the health and comfort of the animal. The lack of access to sufficient amounts of water can have adverse effects on the health and well-being of the animals. In response to this incident and to prevent any future incidents, the institution took corrective actions including but not limited to providing re-training of husbandry staff on the standard operating procedures for daily cage checks and daily animal health checks. This item has been appropriately addressed by the research facility. NOTE - Inspection conducted 6/23/14 through 6/26/14. Exit interview held 6/26/14 on-site with facility representatives. *END OF REPORT*

Consideration of Alternatives. **Protocol #7113 includes a procedure that would be considered more than momentarily painful or distressful but the protocol approved by the IACUC did not contain a written narrative description of the methods and sources used to determine that alternatives were not available to that procedure. Per this Section of the Regulations, whenever a proposal for animal use contains procedures that may cause more than momentary pain or distress to the animals, the investigator is required to consider alternatives to those procedures and provide a written narrative description of the methods and sources used to determine that alternatives were not available. This requirement is important to ensure that all procedures minimize the degree of pain and distress to the animals. The IACUC needs to address this deficiency that was identified for this protocol. Correct by 7/1/17.

In February 2021 laboratory staff for Protocol #07941 reported an unexpected study outcome to the IACUC. The IACUC conducted an investigation and determined that although prior instruction had been provided to laboratory staff, they did not follow the IACUC approved protocol and also did not follow at least 2 of the institution’s guidelines related to animal use. A lower dose of anesthetic than in the approved protocol was administered to the animals and as a result the animals did not remain at a level of anesthesia to allow initiation of the second scheduled procedure. Laboratory staff decided to perform the 2nd procedure later the same day after a second administration of anesthesia, which was not described in the IACUC approved protocol. Per this Section, it shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. The research facility had addressed this item prior to this inspection by providing supplemental refresher training to laboratory personnel on the need to follow the IACUC approved protocol and institutional guidelines. There have been no additional related incidents. Corrected prior to inspection. This inspection was conducted with facility representatives from 7/12/21 through 7/15/21. The exit briefing was held with facility representatives on 7/15/21. *END OF REPORT* End Section

During the review of the semi-annual reports to the Institutional Official, it was noted that the IACUC updated the Semi- annual Report on 2/8/22 and the next update to the report was on 10/4/22, an interval of 8 months between reports instead of at least once every 6 months. Per this Section, one of the functions of the IACUC is to prepare reports of the Committee’s semi-annual evaluations of the program for animal use and its inspection of the facilities; the semi-annual reports to the Institutional Official shall be updated at least once every six months upon completion of the required semiannual evaluations. This process ensures that the Institutional Official is kept informed of the status of both the animal use program and the research facilities. Correct from this date 10/14/22 for all future semi-annual reports to the Institutional Official. This inspection and exit briefing were conducted with facility representatives. *END OF REPORT* n

The USDA reviewed the facility's records for the 5-year-old whale, Havok, during the time he was on 24-hour watch. During the eight hours prior to his death, the staff members conducting the overnight watch documented multiple observations of abnormal behavior and did not alert the Attending Veterinarian. The frequency of these abnormal behaviors markedly increased during this time compared to what had been observed previously. From 0000-2150 on the day prior to Havok’s death, about 40 instances of a combination of “logging,” shaking of pectoral flippers, “ventral up” and rolling behaviors were noted at the facility in various time intervals. Comparatively, during Havok’s last eight hours 2151-0550, the facility's records noted at least 40 instances of 360 rolling, with one instance of four rolling behaviors noted at 0049 hours and five rolling behaviors noted at 0146 hours. Other abnormal behaviors noted to increase in frequency were at least 15 instances of "ventral up” (most of note was the instance of ventral up for 15 seconds at 0101 hours), 3 instances of "gaspy" respirations beginning at 0413 hours, and 7 instances of water seen coming from his blowhole beginning at 0416 hours. There were also 10 instances of "active bleeding” from Havok's rostrum recorded during the two hours prior to his death. This increased frequency of abnormal behaviors constitutes a problem; can indicate rapid deterioration of the animal’s health and may result in prolonged distress. Although staff members were recording their observations of Havok’s behaviors, the veterinarian was not contacted during this eight-hour timeframe until Havok’s death at 0550 hours. The facility failed to provide adequate veterinary care by not using appropriate methods to prevent, control, diagnose and treat diseases during Havok’ s last eight hours. Correct from this date 10/15/21 forward.

The USDA reviewed the facility’s records for the 5-year-old whale named Havok which contained multiple entries documenting injuries the animal sustained on the surfaces of the primary enclosure housing him. On 6/23/21 he injured himself on an area in the medical pool where the posts for the hydraulic mechanism are located. This incident resulted in a 4”x 4” round full thickness wound to the right caudal peduncle that required ongoing treatment. On 7/12/21 “staff note that whale appears to have reduced vision, often colliding with habitat wall and sustained rostral and fluke abrasions”. Indoor and outdoor housing facilities for marine mammals must be structurally sound and must be maintained in good repair to protect the animals from injury. Correct from this date 10/15/21 forward.

From 7/31/21 to 8/27/21 the recorded levels of ORP (Oxidative Reduction Potential), a measure of ozone in the water where the animals live, ranged between 476 and 715mV which is above the levels generally considered to be acceptable for marine mammals. There were eight consecutive days during this time period when the level ranged from 553 to 606. ORP levels that exceed 500mV can suggest that animals may be exposed to high oxidant levels in their pool and require immediate attention by marine mammal facilities. Elevated levels of oxidants in the water, such as ozone, are harmful to marine mammals and may cause irritation to eyes, skin, and the respiratory system. Per this Section of the Regulations the primary enclosure shall not contain water which would be detrimental to the health of the marine mammal contained therein. This item was addressed by the facility prior to the inspection. This inspection was conducted with facility representatives and NOAA personnel on 9/29/21 and 9/30/21. The exit briefing was held 10/12/21 with facility representatives. Additional Inspectors: Tonya Hadjis, Supervisory Animal Care Specialist Carolyn McKinnie, Senior Veterinary Medical Officer - Marine Mammals and ExoticsEnd Section

**Water quality records for the two AASC pools were reviewed. There were two instances in December 2021 when the coliform bacteria count of water samples for both pools exceeded 1,000 MPN and the next water sample recorded was more than 48 hrs later. The coliform count exceeded 1,000 MPN on 12/16/21 and the next recorded coliform count was 96 hrs later on 12/20/21, and the coliform count exceeded 1,000 MPN on 12/21/21 and the next recorded coliform count was 72 hrs later on 12/24/21. **Coliform tests for AASC Pool 1 conducted on 10/2/21 and 12/5/21, and the coliform test for AASC Pool 2 conducted on 12/4/21 had values of “>24,196” MPN. These results do not reflect the actual coliform bacteria counts because there is a “>” (greater than) sign in front of the number which indicates that the result exceeded the limit of the testing method used. No other testing was done on these dates to determine the actual coliform count. Per this Section of the Regulations, the coliform bacteria count of the primary enclosure pool shall not exceed 1,000 MPN (most probable number) per 100 ml. of water. Should a coliform bacterial count exceed 1,000 MPN, two subsequent samples may be taken at 48-hour intervals and averaged with the first sample. If such average count does not fall below 1,000 MPN, then the water in the pool shall be deemed unsatisfactory, and the condition must be corrected immediately. Correct from this date 1/14/22 forward. This inspection was conducted with facility representatives on 1/10/22. The exit briefing was held 1/14/22 with facility representatives. *END OF REPORT* Additional Inspectors: Tonya Hadjis, Supervisory Animal Care SpecialistEnd Section

During the review of the Semi-annual Reports to the Institutional Official (IO), it was noted that: 1. The semi-annual Program reviews conducted by the IACUC in 3/22, 10/22, and 3/23 identified that the research facility’s Contingency Plan had been prepared in November 2013 and needed to be updated. However, the deficiency did not have a specific plan and schedule with dates for correction and the deficiency was not categorized as minor or significant on the three Reports to the IO. 2. The semi-annual Facility inspections of site 001 in 10/22 and 3/23 were conducted by one IACUC member (Attending Veterinarian) and one other person who was not a member of the IACUC. 3. The 3/22, 10/22, and 3/23 Semi-annual Reports to the Institutional Official were not signed by a majority of the IACUC members. Per this Section, one of the functions of the IACUC is to prepare reports of the Committee’s semi-annual evaluations of the program for animal use and its inspection of the facilities. The report must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. The IACUC may use subcommittees composed of at least two Committee members and may invite ad hoc consultants to assist in conducting the evaluations, however, the IACUC remains responsible for the evaluations and reports as required by the Act and regulations. The reports shall be reviewed and signed by a majority of the IACUC members. This process ensures that the Institutional Official is kept informed and provided with accurate information on the status of both the animal use program and the research facilities. Correct from this date 3/24/23 for all future semi-annual reports to the Institutional Official.

During the review of the most recent Semi-annual Report submitted to the Institutional Official (IO) dated 10/18/23, it was noted that the report was not signed by a majority of the IACUC members. Per this Section, one of the functions of the IACUC is to prepare reports of the Committee’s semi-annual evaluations of the program for animal use and its inspection of the facilities. The reports shall be reviewed and signed by a majority of the IACUC members prior to being submitted to the IO. This process ensures that all members of the IACUC Committee have an opportunity to review the report and to include any minority views to ensure that the IO is kept informed and provided with accurate information on the status of both the animal use program and the research facilities. This inspection and exit briefing were conducted with facility representatives. *END OF REPORT* n

Several technicians performing procedures under Protocol A were trained between March 2022 and July 2022. According to their training qualification section of the protocol, some of the sub-investigators will perform procedures “under the guidance of and learning from senor investigators”. There was no indication a senior investigator was present for some studies in progress and assistance was sought from the vet staff or others not listed on the protocol. Additionally, there is no record of a process that ensures that sub-investigators with limited experience with the species and/or procedures on the study are reevaluated to determine proficiency to perform study procedures on their own. Per this Section, it the responsibility of a research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in a study are qualified to perform the procedures outlined in the protocol. This requirement ensures that processes and procedures established and approved by the IACUC are followed for the welfare of the study animals. Qualifications of personnel must be reviewed with sufficient frequency to ensure all study personnel can perform all study procedures without supervision. A process for determining proficiency in performing procedures on the protocol must be established and the personnel qualifications should be updated accordingly. Correct by January 31, 2023. The inspection was conducted from 11/16-18/ 2022. This inspection and exit interview were conducted with the facility representatives and the IO. n

Multiple small areas areas associated with seams along the metal lining on the wall of the goat pen were rusted and peeling up away from the wall, creating roughened edges with the potential for goats to rub against and pull apart further. If the metal wall liners are not kept in good repair, there is a potential for animal injury. The facility must ensure that the facility is structurally sound and maintained in good repair to protect the animals from injury. To be corrected by: August 10, 2021 This inspection and exit interview were conducted with facility representative. End Section

***The corrective action plan for an adverse event that occurred on January 22, 2014, included a change in the process for sexing hamsters at weaning. The IACUC review of the adverse event did not include a verification that formal training of the change in process had occurred. Additonally, there is no formal written document of the new procedure.The IACUC must verify that a corrective action plan as a result of an adverse event has been implemented to ensure there is no repeat of the adverse event. The IACUC must ensure that the new process for sexing hamsters is in writing, either by protocol admendment or an SOP, and that all pertinent personnel have received the required training. Correct by March 20, 2015

Records reviewed did not support the use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries. Five out of twelve animal records reviewed at this inspection indicated that treatment was delayed in animals identified to veterinary personnel for evaluation. Treatments, if directed, were not recorded as having been performed. Appropriate and prompt treatment must be initiated and recorded to assure the best outcome for the animals. Additional preventive measures may also be indicated. Correct: This point forward An exit briefing was conducted with the facility veterinarian. Additional Inspectors Mcfadden Gloria, Veterinary Medical Officer

Eight Primates (50Y,GM2,47A,96C,72X,51S,40T,78U) were noted to have significant hair loss at the time of inspection 29 October 2015. The underlying skin in these areas was pigmented, typical for the species but several also had redness of the skin. There was no crusting of the skin or obvious signs of scratching and the animals were not observed hair plucking during inspection. The manager speculated about the causes of this hair loss including: that it was due to over-grooming for one and likely hormonal for another. She indicated, that in the case of 78U, that the near complete hair loss had been present for years. Below is a summary of the records reviewed in October and January: 78U -The manager stated that the primate had a long history of diarrhea but was not currently receiving any treatment for the hair loss. Veterinary records indicated that the animal had been evaluated for diarrhea multiple times but the hairloss was not assessed other than as a Hair Coat Score (HCS) which was Moderate General alopecia (3) on 6/2/15 and Bald (5) on 10/6/15. This animal was examined 5 November 2015 and had blood drawn for CBC and blood chemistries. No treatment was outlined pending blood results. The results were recorded 10 November 2015 and indicated hypoalbuminemia with no anemia. The animal was placed on albumin and iron supplementation with a plan to recheck the blood in 1 to 2 months. There was no documentation at the facility regarding the hair loss and no record of the veterinarian(cid:25)s recommendations regarding this animals hair loss. 40T - The record showed no workup for hairloss. In the past year, the animal had a wound on the left thigh (4/28/15), gave birth (5/29/15), and had a Physical Examination (PE) (10/20/15). On the PE, the animal was noted to be Overweight (4) with Severe Generalized alopecia (4) but no treatment plan was noted for either observation. No further entries were in the record as of 25 January 2016 (this inspection). 51S - The record showed no workup for hairloss. The most recent PE (9/22/15) showed a Body Condition Score (BCS) of 3.5/5 (despite the facility using a four point scale instead of five as indicated). The HCS was noted as Mild Patchy alopecia (2) No treatment plan was noted. No further entries were in the record as of 25 January 2016 (this inspection). 72X - The record showed no workup for hairloss. In the past year, the animal had a wound (4/16/15), gave birth (6/15/15), had a wound treated on the ventral back (7/15/15), and had a PE (10/20/15). On the PE, the animal was noted to be hypoalbuminemic with Severe Generalized alopecia (4) and diarrhea but no treatment plan was noted for the decreased albumin or the hairloss. The animal was on observation for diarrhea and on 2 November 2015 was found to be dehydrated with a BCS of 5 and a HCS of 4. Blood was drawn for CBC and Serum Chemistries and the animal was placed on Tylosin and LRS (fluids). The results of testing revealed hypoalbuminemia with anemia and the animal was positive for Aeromonas. Tylan treatment was continued and the animal was returned to the colony15 December 2015. No mention of the alopecia diagnosis or treatment plan was made in the record. None of the four animals detailed on the October 2015 inspection had received a diagnosis or treatment plan specifically for hairloss as of this inspection (25 January 2015) as noted above. The facility did develop an "Alopecia Workup of Non-human Primates" plan with workup sheet to be used when examining animals with hairloss. The scoring system was updated and a chart posted in the examination rooms. This plan is in place for all future examinations. As indicated by the manager's comments, hair loss in primates can result from multiple causes. Evaluation by a veterinarian is necessary to determine the most likely cause and develop an appropriate diagnostic and treatment plan. Failure to address abnormal conditions can result in worsening of the condition and unnecessary suffering. All licensees must ensure that observations of abnormal conditions are reported to the attending veterinarian in a timely manner and that appropriate methods are used to prevent, control, diagnose, and treat disease when identified. Correct by having all animals with hair loss examined by a licensed veterinarian who will develop recommendations for diagnosis and treatment. Additionally the licensee shall maintain record of this examination, the veterinarian(cid:25)s recommendations, and any treatments for future evaluation by APHIS Officials upon request. An exit briefing was conducted with the Director of Research Animal Resources.

On January 26, 2016 a young female macaque was found dead in the outdoor portion of her enclosure. This animal had its head entrapped in a ball which was used for enrichment in the animal's enclosure. The ball was described by the facility as having a hole chewed into it sufficient to allow the entire head of the animal to become entrapped with only the mandible of the jaw exposed. This animal died at some time between the PM and AM animal checks. The necropsy of the animal was not conclusive and the facility determined that the likely cause of death was prolonged exposure to the cold in combination with the stress of not being able to remove her head from the ball. At the time of the inspection today the inspectors noted a few badly worn enrichment items. A couple of these items had holes in them. One enrichment item in particular known as a "pill" had a hole in it large enough for a juvenile macaque to stick its head into. This enrichment item has worn to the point that it is potentially hazardous to animals in the enclosure in which it is being used. Furniture type fixtures or objects must be sturdily constructed and strong enough to provide for the safe activity and welfare of the animals in the enclosure. When excessively worn these items must be removed from the enclosure in order to minimize the risk of head or other limb entrapment. Corrected at the time of the inspection. This inspection and exit interview were conducted with various Johns Hopkins University personnel. Additional Inspectors Maginnis Gwendalyn, Veterinary Medical Officer Cohen Kimberley, Veterinary Medical Officer

On July 30th, 2021 ten rhesus macaques escaped from their primary enclosure and into the hallway of the facility. According to facility representatives, the animal care staff employee who was cleaning during the incident did not make sure the latch of the lock was completely secure. The employee was able to return 9 of the rhesus macaques to their primary enclosure. While returning the macaques to their primary enclosure, one juvenile macaque escaped into an uncovered floor drain. The baskets that covered the drain was removed at the time for cleaning. The facility attempted to retrieve the juvenile macaque from the drain, which included digging up the sewer main. The macaque was dead when it was removed from the drain by facility representatives. Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, physical harm, or unnecessary discomfort. This was corrected by the facility through installation of permanent grates over all drains to prevent animals from entering. Other appropriate corrective actions were taken, which included retraining of all employees that work with the primates at the facility. This inspection and exit interview were conducted with facility representatives. Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICER Lemnique Wafer, Assistant DirectorEnd Section

On the morning of February 22, 2024, a pigtail macaque was identified as unresponsive within the outdoor section of the sheltered enclosure. The animal care staff and clinical veterinarian responded to the unresponsive macaque, but the animal was already deceased. It was noted by staff that the macaque had gotten its hand stuck in a narrow gap in the steel floor of the enclosure along the edge of the cage frame. An investigation into the incident was completed by the ACUC and the facility staff following the incident. Primary enclosures must be constructed and maintained so that they protect the nonhuman primates from injury. Corrected before the time of inspection by a corrective action plan and welding steel plates along the perimeter of the floors in the outdoor sections of the sheltered enclosures. This inspection and exit interview were conducted with the facility representatives. This inspection was conducted from 4/25-26/2024 Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICER Jason Sifkarovski, VETERINARY MEDICAL OFFICER n

The minutes of IACUC meetings did not include all activities of the Committee, and Committee deliberations as required. Specifically, adverse events reported to the IACUC were not outlined and there was no indication that the members concurred with the proposed corrections. The Training and Compliance staff generally gives a verbal report to the IACUC. This report is not outlined in the minutes, not formalized and approved, and not available as a written document to reviewers. Omissions of this type do not assure that the IACUC members are provided the proper notification and oversight for the members to assess the research facility's animal program, facilities, and procedures as required. Additionally, failure to include information regarding deliberations of events with significant animal welfare impacts prevents APHIS Officials from evaluating the facilities response and adherence to the Animal Welfare Act. Each research facility shall maintain IACUC records that include minutes of meetings, records of attendance, activities of the Committee, and Committee deliberations. Correct by ensuring that records contain required information from this point forward.