January 5, 2011 Dr. Robert Gibbens, Regional Director USDA-Western Region 2150 Centre Ave., Bldg.

B Mail Stop #3W11 Fort Collins, CO 80526 Via e-mail: Robert.M.Gibbens@aphis.usda.gov Dear Dr. Gibbens, On behalf of People for the Ethical Treatment of Animals (PETA) and our more than 2 million members and supporters, I am submitting this complaint regarding the treatment of animals at the University of Texas Medical Branch at Galveston (UTMB), Certificate #74-R-0073, at 301 University Blvd in Galveston, Texas. PETA’s office has recently received disturbing reports from an inside source at UTMB alleging abuse and neglect of animals housed and used in experiments in UTMB facilities. If true, we believe the alleged treatment of animals constitutes violations of the Animal Welfare Act (AWA). The allegations are that UTMB failed to do the following: 1. Maintain a program of adequate veterinary care [9 C.F.R. §2.33 (b)] 2. Ensure that personnel conducting procedures were qualified to perform their duties [9 C.F.R. §2.32(a)] 3. Handle animals in a way that did not cause trauma, behavioral stress, physical harm, or unnecessary discomfort [9 C.F.R. §§2.32(c)(1)(ii), 2.33(b)(4), 2.38(f)] 4. Provide adequate environment enhancement to promote the psychological well-being of nonhuman primates [9 C.F.R. §3.81 (c)(2)] 5. Provide timely euthanasia to animals experiencing severe or chronic pain or distress [9 C.F.R. §2.31(d)(v)] 6. Provide adequate space to sheep [9 C.F.R. §3.128] 7. Ensure that dogs were removed from cages before hoses were used to clean the enclosures and that sheep and pigs were not wetted during cage cleaning [9 C.F.R. §3.11(a), 9 C.F.R. §3.131(a)] In addition, the allegations indicate that the UTMB Institutional Animal Care and Use Committee (IACUC) failed to do the following: 1. Adequately inspect and review the laboratory’s animal facilities and the facility's program for humane care and use of animals [9 C.F.R. §§2.31(c)(1)-(2)]

2. Ensure that the "animals' living conditions [would] be appropriate for their species … and contribute to their health and comfort" [9 C.F.R. §2.31 (d)(1)(vi)] 3. Ensure that principal investigators “considered alternatives to procedures that caused more than momentary or slight pain or distress to the animals” [9 C.F.R. 2.31(d)(ii)] I. Failure to maintain a program of adequate veterinary care Section 2.33(b) of the Animal Welfare Regulations (AWRs) states: “Each research facility shall establish and maintain programs of adequate veterinary care.”1 The regulation further specifies that adequate care includes the “availability of appropriate facilities, personnel, equipment, and services,”2 the “use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries,”3 “daily observation of all animals to assess their health and well-being [including] a mechanism of direct and frequent communication … so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian,”4 “guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia”5 and “adequate pre-procedural and post-procedural care in accordance with current established veterinary medical and nursing procedures.”6 The level of care stipulated by this regulation was reportedly not met by UTMB: i. Several problems were noted in the use of dogs by principal investigators Jiande Chen and Jieyun Yin to test an experimental product for irritable bowel syndrome (IBS): a. Two dogs used in this protocol reportedly died following surgery to repair colonic cannulas when veterinary staff did not have, and thus failed to provide, anesthetics, and lacked familiarity with monitoring equipment. While the facility’s failure to stock the necessary anesthetics constitutes a violation of 9 C.F.R. §2.33(b)(1), the episode also reflects the UTMB’s failure to ensure that personnel are adequately qualified to perform their duties—as required by 9 C.F.R. §2.32(a). b. Another dog on the same protocol experienced a serious negative reaction to the experimental drug; her temperature rose to 103.2°F and her posture suggested that she was in pain. The dog was euthanized at this point, but a necropsy was not performed. A necropsy could have provided the experimenters with insights into the systemic challenges posed by the experimental product. The experimenters’ failure to conduct a necropsy constitutes a failure of 9 C.F.R. §2.33(b)(2) and §2.33(b)(5). c. The experimenters followed the advice of a consulting surgeon who recommended withholding food for approximately three days from three additional dogs used in the same protocol. While the decision to withhold food

1 2

9 C.F.R. §2.33(b) 9 C.F.R. §2.33(b)(1) 3 9 C.F.R. §2.33 (b)(2) 4 9 C.F.R. §2.33(b)(3) 5 9 C.F.R. §2.33 (b)(4) 6 9 C.F.R. §2.33 (b)(5)

from dogs for three days constitutes an extreme measure and a significant change to the protocol, it is not known whether the IACUC reviewed this significant change to the protocol, as is required by C.F.R. §2.31(c)(7). Certainly, 9 C.F.R. §2.31(d)(xi)(3) is very clear in stipulating that consultants “may not approve or withhold approval of an activity.”7 ii. Principal investigator Daniel Traber uses sheep, pigs, and mice in experiments aimed at studying burn and smoke inhalation injury. Several sheep and a pig in Traber’s laboratory in Building 21 apparently suffered serious injuries—including a broken leg and an unknown trauma that caused a sheep’s intestines to penetrate her chest cavity and required euthanasia—because husbandry staff forced the animals to jump over gates instead of using ramps to remove them from enclosures. The failure to use appropriate methods to prevent injury in these animals is a transparent violation of 9 C.F.R. §2.33(b)(2). The fact that several animals were seriously injured in this manner calls into question whether the employees responsible for moving the animals were given adequate guidance in the handling of animals, as required by 9 C.F.R. §2.33(b)(4). Standard operating procedures at UTMB require that ramps be used when moving pigs and sheep out of enclosures; however, workers ignored this protocol, potentially exposing animals to injury. While the IACUC should have been notified of the injuries, and certainly of the incident in which the sheep had to be euthanized, it is unclear what steps—if any—the IACUC took to ensure that SOPs were being followed. Contrary to “current established veterinary medical and nursing procedures,” principal investigators and their staff failed to enter critically-important medical information, such as treatments, into animals’ medical records, in violation of 9 C.F.R. §2.33(b)(5). a. Medical records for dogs used in Jiande Chen’s irritable bowel syndrome (IBS) experiments are incomplete, as only the animal health staff had been entering information in the medical records, but no information had been written in the records by the experimenters and their staff. Noting this deficiency, on June 11, 2010, Dr. Karen Vargas, one of the attending veterinarians at UTMB, instructed Hanaa Sallam, who we believe is a post-doctoral fellow working with Jiande Chen, to record all of the procedures she performs on the dogs used in the IBS study in the medical records. Sallam told Dr. Vargas that she had been working with the dogs for seven years and never entered information in the medical records. The dismissive attitude exhibited by Sallam in this conversation exhibits an apparent failure on the part of UTMB to ensure that “the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use,”8 as required by 9 C.F.R. §2.33(a)(2). b. Medical records for sheep used in principal investigator Daniel Traber’s burn and smoke inhalation injury experiments appear to be similarly deficient. On August 24, 2010, Cheryl Bobbitt, Veterinary Technician Supervisor of UTMB’s Animal Resource Center (ARC)—responsible for observing animals for health problems, examining sick or injured animals reported by animal attendants, and treating

iii.

7 8

9 C.F.R. §2.31(d)(xi)(3) 9 C.F.R. §2.33(a)(2)

animals as the veterinarians and principal investigators recommend, and Maylinn Tarbutton, UTMB’s Good Laboratory Practices Coordinator, met with one of Daniel Traber’s assistants to discuss properly completing the animal medical records (AMRs) for sheep in Traber’s experiments. In the meeting, it was noted that for several months, the only entry in the AMRs for the sheep was “euthanized: end of study.” Absent from these records were notes on medical procedures and manipulations performed on the animals. Bobbitt said that at some point, Traber’s staff stopped writing anything besides the animals’ euthanasia in their medical records. Even then, the method of euthanasia used was not recorded. iv. Members of Daniel Traber’s staff reportedly failed to report health problems in animals—and allowed their suffering to continue unabated—because they feared being disciplined. In the aforementioned August 24, 2010, meeting, Traber’s assistant told Cheryl Bobbitt and Maylinn Tarbutton that Traber’s staff does not report problems or come to the veterinarians when an animal needs care for fear that they will be ridiculed. The assistant told Bobbitt that they hide as much as they can from the ARC staff and deal with the ARC staff only when absolutely necessary. The assistant told Bobbitt that many departments view the veterinary staff and the entire ARC department as “the animal police” and avoid ARC rather than utilize the veterinary staff and ARC. This dysfunctional culture undermines both the spirit and letter of 9 C.F.R. §2.33(b)(3), which stipulates “daily observation of all animals to assess their health and well-being [including] a mechanism of direct and frequent communication … so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian.” UTMB principal investigator Nigel Bourne uses ferrets to study infectious diseases. In Bourne’s laboratory, ferrets were deeply anesthetized, but would frequently die within one to two days. Dr. Karen Vargas, one of the attending veterinarians, and Dr. William Masters, the Animal Resources Center director, suggested a protocol amendment to attempt to address the animal deaths, but Dr. Donald Deyo, a veterinarian who assists Bourne, reportedly ignored the suggestions. Dr. Deyo’s alleged indifference to the suggested amendment undermines the intention of 9 C.F.R. §2.33(b)(4). The failure to take seriously the guidance of the attending veterinarian gives further support to the notion that UTMB fails to ensure that the attending veterinarian has appropriate authority to make decisions regarding animal care, as required by 9 C.F.R. §2.33(a)(2). It is not known whether the matter was brought to the attention of the IACUC. The UTMB source reports that on September 20, 2010, Dr. Deyo and Robert Washington, one of the laboratory technicians, prepared two goats for a laboratory training session for emergency physician residents in the second floor surgery suites of Building 21. Washington held a goat while Dr. Deyo gave an IV injection of pentobarbital in the jugular vein. No pre-anesthetic injections were given. Dr. Deyo placed an endotracheal tube and jugular catheter, while Washington shaved the goats’ chests and areas near their abdomens. The goats were placed on an IV drip which contained additional pentobarbital. In deviation from the IACUC-approved protocol, the goats were not placed on isoflurane gas anesthesia at any point. Within five minutes of

v.

vi.

being on the surgical table, one of the goats was not breathing and a heartbeat could not be detected. The goat died on the table. Washington dismissed the incident, saying that the goats usually died early in the procedure and it wasn’t a “big deal.” More than half the IV fluids were gone at this point; PETA’s source at UTMB speculated that Dr. Deyo had set the drip’s discharge rate too fast and that the goat died of anesthetic overdose. The IACUC-approved protocol also stated that Dr. Deyo was supposed to be present for the entire experiment; however, he left the room after he induced anesthesia and did not return. The failure to use gas anesthesia, as required by the IACUC-approved protocol, and Dr. Deyo’s failure to remain present in the room through the procedure constitute a failure to ensure “availability of appropriate facilities, personnel, equipment, and services” as required by 9 C.F.R. §2.33(b)(1), while also undermining the system of oversight that the IACUC is intended to provide. Washington’s comment that goats usually died early in the procedure seems to indicate that Dr. Deyo frequently deviated from the IACUC-approved protocol. It is not clear whether the manner in which the goat died was reported in this incident, or whether the earlier incidents to which Washington referred were ever reported. II. Failure to ensure that personnel conducting procedures are qualified to perform their duties Section 2.32 (a) of the AWRs states that: “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.”9 And §2.32(c) specifies that “[t]raining and instruction of personnel must include guidance in … [h]umane methods of animal maintenance and experimentation including: … (i) The basic needs of each species of animal10 [and] (ii) proper handling and care for the various species of animals used by the facility.”11 Several of the episodes described in Section I also point to UTMB’s failure to ensure that personnel are qualified to perform their duties. i. The difficulties experienced by the veterinary staff in working with the monitoring equipment, described in Section I.i.a, indicate a failure on the part of UTMB to ensure employees were qualified to perform their duties—in violation of 9 C.F.R. §2.32(a)—and suggest that perhaps sufficient training was not provided to employees, in violation of 9 C.F.R. §2.32(b). The widespread failure on the part of experimenters and their staff to record vital data in animal medical records suggests a failure on the part of UTMB to train staff on the humane methods of animal maintenance, of which adequate medical record keeping is certainly a part, in violation of 9 C.F.R. §2.32(c)(1).

ii.

III. Failure to handle animals in a way that does not cause trauma, behavioral stress, physical harm, or unnecessary discomfort
9

9 C.F.R. §2.32 (a) 9 C.F.R. §2.32 (c)(1)(i) 11 9 C.F.R. §2.32 (c)(1)(ii)
10

Section 2.32(c)(1)(ii) of the AWRs states: “Training and instruction of personnel must include guidance in … [h]umane methods of animal maintenance and experimentation, including … [p]roper handling and care for the various species of animals used by the facility.”12 Additionally, Section 2.33(b)(4) of the AWRs requires animal experimentation facilities to “establish and maintain programs of adequate veterinary care that include … [g]uidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia.”13 As well, Section 2.38(f)(1) specifies that “[h]andling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort.”14 The repeated injuries caused to animals as a result of husbandry staff forcing the animals to jump over gates instead of using ramps to remove them from enclosures, as described in Section I.i, suggests a failure on the part of UTMB to provide adequate guidance to personnel on proper handling of animals—in violation of 9 C.F.R. §2.32(c)(1)(ii), §2.33(b)(4), and §2.38(f)(1). IV. Failure to provide adequate environment enhancement to promote psychological wellbeing of nonhuman primates Section 3.81 of the AWRs mandates that: “research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates.”15 Title 9 C.F.R. §3.81(a) specifically stipulates that the “environment enhancement plan must include specific provisions to address the social needs of nonhuman primates of species known to exist in social groups in nature.”16 The UTMB insider reports that a macaque monkey, who was not part of a protocol, was housed by herself in a stainless steel cage in the Medical Research Building, where she has no contact with or opportunity to see or hear other non-human primates. It is not known how long this macaque was housed in the room by herself. V. Failure to provide timely euthanasia to animals experiencing severe or chronic pain or distress Section 2.31(d)(v) of the AWRs stipulates that: “Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure.”17 This regulation was allegedly violated at UTMB:

12 13

9 C.F.R. §2.32(c)(1)(ii) 9 C.F.R. §2.33(b)(4) 14 9 C.F.R. §2.38(f)(1) 15 9 C.F.R. §3.81 16 9 C.F.R. §3.81 (a) 17 9 C.F.R. §2.31(d)(v)

i.

ii.

In June 2010, it was observed that a ferret in the Galveston National Laboratory (GNL) was not eating and was lethargic for a full week. The GNL staff had observed the ferret’s declining health, but waited for attending veterinarian, Dr. Monica Fann, to examine him or her. The ferret was not euthanized until July 2, 2010—more than one week after the ferret’s deteriorating health was first observed. On September 3, 2010, a sheep was used in a back surgery experiment under the direction of principal investigator Debbie Wilkes. Following the surgery, a husbandry technician named Willie transported the sheep to the cage in which the sheep was held— cage 1.408-01 in Building 21. On September 4, Willie noticed that the sheep was having trouble standing. On September 5 and 6, Willie observed that the sheep wouldn’t stand up. It is unclear whether Willie reported the sheep’s condition to either his supervisor or one of the attending veterinarians at the facility. On September 7—four days after the surgery—Allan Silva from UTMB’s IACUC observed that the sheep was unable to stand up. Dr. Fann observed the sheep and determined from the sheep’s medical record that the sheep hadn’t received any pain relief since September 3. Dr. Fann spoke with Wilkes, but learned that Wilkes wouldn’t be able to check on the sheep until the following day, September 8. In fact, it was not until late in the afternoon September 8 that Wilkes examined the sheep, and it was not until this point, four days after the sheep was first observed having difficulty standing, that the animal was finally euthanized.

VI. Failure to provide adequate space to sheep Section 3.128 of the AWRs mandates that for warmblooded animals other than dogs, cats, rabbits, hamsters, guinea pigs, nonhuman primates, and marine mammals, “[e]nclosures shall be constructed and maintained so as to provide sufficient space to allow each animal to make normal postural and social adjustments with adequate freedom of movement.”18 For approximately 10 days before they are burned and for up to three weeks afterwards, sheep used in Daniel Traber’s experiments aimed at studying burn and smoke inhalation injury were chained in crates —so narrow and small that they could not even turn around. VII. Failure to remove dogs from cages before using hoses to clean the enclosures; failure to implement measures to prevent wetting of sheep and pigs during cage cleaning In describing the cleaning of primary enclosures for cats and dogs, §3.11(a) of the AWRs stipulates that: “Excreta and food waste must be removed from primary enclosures daily, and from under primary enclosures as often as necessary to prevent an excessive accumulation of feces and food waste, to prevent soiling of the dogs or cats contained in the primary enclosures, and to reduce disease hazards, insects, pests and odors. When steam or water is used to clean the primary enclosure, whether by hosing, flushing, or other methods, dogs and cats must be removed, unless the enclosure is large enough to ensure the animals would not be harmed, wetted, or distressed in the process. Standing water must be removed from the primary enclosure and animals in other primary enclosures must be protected from being contaminated with water and other wastes during the cleaning.”19 Section 3.131(a) of the AWRs requires that for animal
18 19

9 C.F.R. §3.128 9 C.F.R. §3.11(a)

species for whom standards of care are specified in Subpart F (pertaining to warmblooded animals other than dogs, cats, rabbits, hamsters, guinea pigs, nonhuman primates, and marine mammals): “When enclosures are cleaned by hosing or flushing, adequate measures shall be taken to protect the animals confined in such enclosures from being directly sprayed with the stream of water or wetted involuntarily.”20 Workers at UTMB reportedly used high-pressure hoses to spray runs housing dogs, sheep, and pigs—while the animals were still in them. i. On September 15, 2010, Chris Kite, a husbandry technician in the Animal Resource Center who used to work in Building 21, mentioned to a colleague that the husbandry technicians hose out the runs with the sheep and pigs in the runs. Chris said that Karolyn Nivens, the Building 21 animal husbandry supervisor, knows that the husbandry staff hoses the enclosures while animals are still in them. They hose the cages to wash the fecal matter into the drains, but the sheep and pigs are soaked and stressed in the process. Dogs would become wet and were forced to stand in bleach-water-soaked runs. The floors were not dried with a squeegee. Several employees commented on how the dogs smelled like bleach. Apart from the 10 days prior to being burned and three weeks following, sheep used in Daniel Traber’s burn experiments were housed in groups of three to four in runs fitted with plastic grid flooring to allow the urine and fecal material to fall through. Employees observed that after the runs were hosed down, the sheep, walls, floors, and doors would be soaking wet.

ii.

iii.

VIII. IACUC Failures Section 2.31 of the AWRs specifies numerous responsibilities for IACUCs, highlighting the IACUCs’ intended role as the animals’ last line of defense. Section 2.31(c)(1) of the AWRs stipulates that the IACUC must “[r]eview, at least once every six months, the research facility's program for humane care and use of animals,”21 while Section 2.31(c)(2) further requires that the IACUC must “[i]nspect, at least once every six months, all of the research facility's animal facilities, including animal study areas.”22 Section 2.31(d)(1)(ii) of the AWRs requires IACUCs to ensure that principal investigators “considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals.”23 And, Section 2.31(d)(1)(vi) of the AWRs requires IACUCs to ensure that the “animals’ living conditions will be appropriate for their species … and contribute to their health and comfort.”24 Several scenarios have been described to PETA, which appear to indicate either failure on the part of the UTMB IACUC to adequately review protocols and implement adequate animal care policies—or failure on the part of experimenters to conform with approved protocols and on the part of personnel to implement policies.
20 21

9 C.F.R. §3.131(a) 9 C.F.R. §2.31(c)(1) 22 9 C.F.R. §2.31(c)(2) 23 9 C.F.R. §2.31(d)(1)(ii) 24 9 C.F.R. §2.31 (d)(1)(vi)

i.

ii.

iii.

iv.

Our source alleges that during a recent visit to the ARC building, IACUC members ignored animals’ conditions, the filth in which they are housed and internal records showing that staff was neglecting the animals’ well-being—in violation of 9 C.F.R. §§2.31(c)(1)-(2). The alleged widespread failure on the part of experimenters and their staff members to record medical procedures and manipulations performed on the animals in the animals’ medical records, and the appearance that this contravention of current established veterinary medical practice has been going on for years, calls into question why this serious deficiency was not identified earlier. The situation at UTMB with its apparent culture of disregard for maintenance of detailed animal care records supports the allegation that UTMB’s IACUC was failing to conduct thorough inspections of the facility, including animal care records. The housing of sheep used in Daniel Traber’s burn and smoke inhalation injury experiments—for ten days prior to the infliction of the injury and three weeks following the injury—prohibits the sheep from making “normal postural … adjustments with adequate freedom of movement,” as required by the Animal Welfare Regulations. It is unclear whether the IACUC permitted an exemption to Traber for the inhumane method of housing sheep prior to and following the painful experiments, but certainly, in the absence of an exemption, it is clear that the IACUC has, in this case, failed to ensure that the animals’ living conditions contribute to their health and comfort, as required by 9 C.F.R. 2.31(d)(1)(vi). Following the incident described in Section I.vi, attending veterinarian, Dr. Fann, stated that to achieve the goals of the surgical training—to give the residents experience placing arterial catheters, checking for intraperitoneal bleeding via a small incision and a scope, placing a tracheotomy tube, and placing a tube in the chest for collapsed lungs—it was not necessary for the goats to be alive and explicitly stated that cadavers could have been used in place of live goats. As Dr. Fann serves on the UTMB IACUC, it is very concerning that the UTMB IACUC approved the use of live goats for training, the goals of which could have been achieved using cadavers.

The very serious nature of these allegations warrants immediate investigation by the USDA. The actions of UTMB staff show a flagrant disregard for the law and for the animals for whom they are responsible. We urge your office to treat this matter with gravity and respond swiftly to investigate and take appropriate disciplinary action. I look forward to hearing from you and am available to assist you in your investigation. I can be reached at 410-889-1035 or alkac@peta.org. Sincerely, Alka Chandna, Ph.D. Laboratory Oversight Specialist Laboratory Investigations Department

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