Information on Santa Cruz Biotechnology, Inc.

USDA Enforcement Actions

USDA Hearings Against SCBT

Inventories

The following figures were obtained from animal inventories at SCBT, as documented by USDA veterinary inspectors while conducting compliance inspections. AWI believes it likely that the dramatic change is related to two key events in August 2015: the USDA filing an unprecedented third complaint for violations of the Animal Welfare Act against SCBT and the USDA presenting a strong case demonstrating violations by the company before an administrative law judge. For further details see AWI's February 2016 press release.

DATE

RABBITS

GOATS

April 22, 2014

3000

3400

November 6, 2014

3000

2660

July 7, 2015

2471

3202

September 23, 2015

1714

0

January 12, 2016

0

0

USDA Inspection Reports

Santa Cruz Biotechnology, Inc., operates as both a USDA registered research facility and a USDA licensed dealer. Inspections on each of the dates below include the reports for SCBT as both a dealer and a research facility (the certificate number 93-B-0192 in the upper right corner designates the dealer and 93-R-0380 designates the research facility).

May 5, 2010

July 13, 2010

February 8, 2011

April 5, 2011

October 4, 2011

March 6, 2012

April 19, 2012

May 2, 2012

May 24, 2012

June 26, 2012

August 23, 2012

September 26, 2012

October 31, 2012

December 18, 2012

February 20, 2013

May 14, 2013

September 10, 2013

April 22, 2014

November 6, 2014

July 7, 2015

September 23, 2015

January 12, 2016

AWI Requests Action from Federal Agencies

Letter to USDA's Secretary, Tom Vilsack

Letter to NIH's Director, Francis S. Collins, MD, PhD

SCBT: Supplying Antibodies Is Big Business

For years, SCBT has been one of the world's largest suppliers of antibodies produced in animals. A survey published in 2007 by Biocompare ranked it as the “top company” for all types of antibodies purchased. Another survey published in 2009 by Bioinformatics also ranked it as the largest. In 2012, a survey published in The Scientist ranked SCBT a close second among 15 of the biggest suppliers globally, while another 2012 survey by BioAstrum ranked the company second in the number of citations published in scientific journals in 2011.

USDA Hearings Against SCBT: August 2015

The following are AWI's notes from the administrative hearing brought by the USDA against SCBT for apparent violations of the Animal Welfare Act.  The hearing was held before Judge Janice Bullard from August 18-21, 2015.

Tuesday, August 18, 2015

The hearing for the USDA's case against Santa Cruz Biotechnology, Inc. (SCBT) before Administrative Law Judge Janice Bullard began today. Colleen Carroll is the attorney from the USDA's Office of General Counsel and Mark Lynch; Dr. Jeannie Perron, and Cortlin Lannin are attorneys with Covington & Burling, the extremely powerful law firm representing SCBT.

The hearing began with a variety of housekeeping matters, but we learned that the USDA intends to call a “mystery witness,” who is a former employee of SCBT. The person has not wanted to be identified because of a concern that there would be pretrial retaliation and the person is worried for her safety. This individual has been subpoenaed to testify, and it is expected she will do so later this week.

The first person to testify was Dr. Carol Clarke, Research Program Manager with the USDA's Animal Care program. She testified about an inspection of SCBT she participated in on March 6, 2012, where she observed a number of goats in poor condition. She described one goat with large areas of hair loss and scabby lesions and another goat who was lame and extremely thin. Dr. Clarke described the process of extracting blood for antibody production and the need to be vigilant with the animals' health and condition if they are being bled on a regular basis. She described SCBT's failure to monitor the condition of its goats to ensure their welfare.

Dr. Laurie Gage testified next. Although she is USDA's big cat and marine mammal specialist, the title doesn't accurately represent all the work she has done for the department. She participated in an inspection of SCBT on July 13, 2010. She stated that she saw a number of animals “in distress or pain or suffering.” One was a goat with a “nasty, fairly fresh wound on its hind leg” that she was told was probably from a coyote attack. There were two debilitated goats: One was put out in the hot sun by an untrained worker; this goat was unable to move on his/her own to the shade. Another was a goat lying in the food bunker, also unable to move. Though a staff member put food nearby, it was out of reach. However, when the inspector presented food within reach, the goat ate it.

The final witness for the day was Dr. Marcy Rosendale, a veterinary medical officer with the USDA's Animal Care program since 2003. She has conducted inspection after inspection of SCBT from 2003 right up to the most recent inspection conducted last month. She spent the afternoon describing all of the atrocities she had seen. When asked about the facility's ability to comply with the law, Dr. Rosendale replied, “I don't see a will. Others do it, but I'm not seeing a willingness to come into compliance.” She described seeing “the same problems over and over and over again” at SCBT.

Dr. Rosendale described how various employees of SCBT had denied the existence of another location with a barn and additional animals farther down the road from the main area. Even when the employees were asked directly the existence of this other location, they said no, there wasn't one. Then, later, Dr. Rosendale described a call she received from a past employee of SCBT who apologized for denying there was an additional location with more animals. The former employee said there were 1,300 goats at this other location—that the USDA had not been informed of and had not inspected.

Dr. Rosendale will be cross-examined by SCBT's attorneys tomorrow.

Wednesday, August 19, 2015

The hearing resumed with SCBT's attorney, Mark Lynch, cross-examining Dr. Rosendale, which was followed by redirect from Colleen Carroll. When questioned about whether she inspects other antibody production facilities, Dr. Rosendale said that she inspects two others that also have goats and rabbits; in responding to a crucial follow-up question from Ms. Carroll, Dr. Rosendale said that these other facilities do not have the same deficiencies she has found at SCBT.

Mr. Lynch moved on to ask Dr. Rosendale about her conversation with Dr. Robin Parker, who had been SCBT's veterinarian. After she left SCBT, Dr. Parker contacted Dr. Rosendale to inform her of an additional facility that Dr. Parker said had been concealed from the USDA. This site was referred to as Barn H7. Dr. Rosendale recounted how upset Dr. Parker was by what was going on at SCBT, and she recalled that Dr. Parker was crying during one inspection when one of the goats died in front of them. Dr. Parker told Dr. Rosendale that she felt so overworked, working 70-80 hours a week with no relief, that she thought she would have a nervous breakdown, and her own doctor put her on medical leave. She was fired while on leave before she could resign.

In response to a question from Judge Bullard, Dr. Rosendale emphasized that the USDA did NOT know about the other (H7) facility prior to hearing about it from Dr. Parker. Most importantly, Dr. Rosendale was able to establish that she asked on many occasions (as was customary) and in different ways if there were other facilities that should be inspected, and she was always told “No.” She added that Dr. Parker “remembered me asking [if there were other facilities that should be inspected] and felt guilty” for not telling her about the undisclosed H7/Lake Ranch barn, which was located several miles from the rest of the compound.

Dr. Rosendale also testified to the inadequacy of the staffing levels for the number of animals at SCBT; that as the number of animals increased, so did the number of problems; and that when she would return to check on noncompliant items from a previous inspection, there would be new noncompliant items.

The last witness on Wednesday was Dr. Pamela Smith, a veterinary medical officer (VMO) for Animal Care in the San Francisco Bay area. She testified that she accompanied Dr. Rosendale on 13 inspections of SCBT and found a recurring theme: animals in poor condition for whom it seemed nothing was being done. There were no notes in the records that a problem existed, much less that anything was being done. She recalled the inspection that involved a goat with the broken leg; she characterized as “pretty shocking” and “quite memorable” the fact that this animal hadn't received any veterinary care. The next inspection was also “pretty shocking”: This was when the “goat died in front of us.”

Dr. Smith also testified that SCBT employees were repeatedly asked whether there were other facilities that should be inspected, and that those employees repeatedly said there were not. When they finally did find out about barn H7/Lake Ranch from Dr. Parker and asked SCBT staff yet again about another site, they were told, “well, there might be one” but it was difficult to get to; additionally, the SCBT vet, Dr. Naomi Weinberg—even though she said she had never been there—found it with no problem. Dr. Smith said Dr. Weinberg was “sheepish and uncomfortable” because “she knew we knew.”

Dr. Smith said that at the previously undisclosed barn they found elderly goats with a lot of health problems; there were “a lot of citations” as a result. Ms. Carroll asked specifically about the cause of nasal discharge in several goats, and Dr. Smith said it was likely a viral respiratory infection with a secondary bacterial infection.

Ms. Carroll then asked Dr. Smith's opinion of the effectiveness of the Institutional Animal Care and Use Committee (the oversight body at research facilities, mandated by law). Dr. Smith had several concerns about SCBT's IACUC. She said the IACUC should have been discussing the inspection reports and should have been having “substantive discussions about the repeated problems,” but there was no evidence of that. She had the impression that the Committee was “not that engaged.” Moreover, the community member[1] of the IACUC was a neighbor who, after repeated attempts by USDA to contact him, resigned from the Committee.

At that point, Dr. Smith said that the IACUC was not properly functioning and should not have approved changes in any of the protocols, but it did so anyway. Dr. Smith also discovered goats with lesions and swelling in their shoulders from injections, when the protocol called for them to be injected in the ribcage. The SCBT vet, Dr. Warden, contended that since the scapula is on top of the ribcage, that's still the ribcage. To Dr. Smith, not only was this procedure contrary to the protocol, but the swelling was indicative of the employees not doing it properly, thereby making it a health concern.

[1]This unaffiliated member is mandated by the Animal Welfare Act to represent the "general community interests in the proper care and treatment of animals."
 

Thursday, August 20, 2015

The first to testify was the “mystery witness.” She is Dr. Robin Parker, who worked as a veterinarian for SCBT beginning in early 2011. In addition to her responsibilities for the approximately 11,000 goats and 6,000 rabbits at SCBT during her tenure, a primary responsibility was to care for about 100 horses at the ranch and a herd of about 200 Gelbvieh cattle owned by John and Brenda Stephenson (who also own SCBT). Her responsibilities expanded still further with the launching of a new venture by the Stephensons; Santa Cruz Animal Health, distributing prescription drugs to veterinarians. This office was 35 miles away.

Within the first month after starting her job at SCBT, Dr. Parker said she was told about a location at the facility that was undisclosed to the USDA, and she was instructed that the situation needed to remain that way. While the employees at SCBT were aware of this location and that the animals there were being bled for antibody production, she said she was told that SCBT didn't want the USDA to know about it because SCBT was trying to minimize the potential for further citations by the inspectors. Dr. Parker said the company CEO, John Stephenson, was the one who made the decision not to have the location revealed. It was felt by Dr. Stephenson that the USDA tended to nitpick on its inspections of SCBT. Later, under cross-examination by SCBT attorney Mark Lynch, Dr. Parker was asked if she felt that USDA was nitpicky and she replied, “No sir, I don't. I would be hard-pressed to say that's true.”

Dr. Parker described some of her specific concerns with SCBT. Bleeds were conducted on animals without determining their eligibility by weighing them or checking their hematocrit levels[1] to ensure that the appropriate amount of blood was taken and that the animals were remaining stable. While the lab claimed that it had a number of veterinary technicians on staff, none were actually registered as such, which Dr. Parker said is mandated by the State of California. Dr. Parker stated that lack of training was an issue with SCBT staff. The member on the IACUC serving as the “unaffiliated member” mandated by the AWA to represent “general community interests in the proper care and treatment of animals” was the real estate agent who had been instrumental in the purchase of the company property.

Dr. Parker said that there was a lack of shade for the animals and the temperatures in summer would exceed 100 degrees. The feeders used for the goats were actually intended for cattle and therefore they did not work well for the goats even when SCBT tried removing the legs on the feeders. Goats climbed in them and urinated and defecated. The goats would also get stuck in them and when the feeders were originally set up, hay particles would fall into the animals' eyes, creating irritation and conjunctivitis. Eventually, some proper feeders were acquired, but only for use by those goats in the hospital facility, not at any other locations.

Under questioning by USDA attorney Colleen Carroll, Dr. Parker acknowledged that she was present on at least one occasion when a goat was agonal (exhibiting gasping, labored breathing) and euthanasia was called for. In fact, the goat died before she was able to euthanize it. When asked if there were animals that needed veterinary care and were agonal, she replied, “Yes.”

After 14 months, Dr. Parker took medical leave from her job, and she was terminated before she returned to work.

USDA rested its case.

The first called to testify for SCBT was Dr. Robert Peterson of Case Western Reserve University in Cleveland. He defended the manner in which SCBT used Complete Freund's Adjuvant (CFA) and Incomplete Freund's Adjuvant[2] based on his reading of documents about the facility, including its Standard Operating Procedures, protocols, photographs, and USDA inspection reports. He stated that CFA is accepted by the research community, and that while it is not ideal, “it is the gold standard.”

Under cross-examination by Ms. Carroll, Dr. Peterson stated that he has never been to SCBT. It appeared that he was unaware that they make their own CFA, as most places don't have the capacity to do so. When asked if the condition of the animal enclosures could be a factor with bacterial lesions, he replied, “Yes.” When asked whether, if bacteria are in the CFA, it could be transmissible to rabbits, he said, “Yes.” When asked if this could cause granulomas, he again replied, “Yes.”

Dr. Peterson explained the attention needed for animals who are being bled, the importance of looking at the weights of animals and their condition, including the condition of their coats, and that as a prey species, goats and rabbits may not show pain—rather, they hide it. At Case Western these animals would be assessed daily.

Finally, when asked about the use of specific-pathogen free (SPF) rabbits in antibody production, Dr. Peterson appeared unsure. He said that Case Western purchases and uses SPF rabbits for antibody production. Based on this line of questioning, it seems that the rabbits SCBT uses for antibody production are not SPF.[3]

The final witness for the day was Dr. Don Warden, SCBT's attending veterinarian. He first began doing work for the facility in 2003, and then he became their attending vet in either 2005 or 2007 (he couldn't recall which). He talked about the great working relationship he had with the staff and that he is viewed as a friend and that they have no reservations in coming to him with any issues.

SCBT attorney Cortlin Lannin began a process of going methodically through the animals identified by the USDA to be of concern and Dr. Warden explained away most of them. For example, he felt it was not possible that a staff member would have placed a goat that wasn't ambulatory out in the sun; the animal must have gotten out there on its own. Or those goats that choose to go in the feed bunker do so because it's “a nice cozy place to lie down and eat their food.” Where the USDA expressed concern that animals were lame or thin or experiencing respiratory conditions, Dr. Warden would explain that he was taking time to try to help the animals recover and just keep an eye on them. Regarding a recumbent animal he was asked about, Dr. Warden first explained that the term just means the animal is lying down. However, he acknowledged that if it was prodded and didn't get up, then you have a problem. In this case the goat “went to a corner because it didn't feel well. It cuddled up in there.” However, he did add that in hindsight he would have handled this particular goat differently.

At 6:00 p.m. Judge Bullard suggested that questioning of Dr. Warden be resumed in the morning. The judge noted that she would have some questions specifically about the veterinary records and wondered if Dr. Warden would be the one able to answer them or if someone else was going to testify about the records. She said there appeared to be no name associated with a number of records, many of them were not in chronological order, and there were other issues.

[1]volume percentage of whole blood comprising red blood cells

[2]These adjuvants stimulate immune response, produce an inflammatory reaction and are used in antibody production and other areas of research immunology. USDA Policy 11 states that use of CFA “may” cause more than momentary or slight pain and may produce a severe inflammatory response depending on the species and route of administration. The National Institutes of Health Office of Animal Care and Use's Guidelines for the Use of Adjuvants in Research: Special Emphasis on Freund's Adjuvant state that FCA can result in “severe side effects,” that alternatives should be used “whenever possible,” and that adjuvants that produce less intense inflammatory responses should be considered for “routine antibody production.” All use of adjuvants must be approved by the Institutional Animal Care and Use Committee and “use of adjuvants that could induce a severe reaction must be scientifically justified.” The Guidelines further state that CFA can produce “local inflammation and granulomatous reactions at the site of injection, lymph node structural changes, chronic inflammation, skin ulceration, local abscess or tissue sloughing, diffuse systemic granulomas secondary to migration of the oil emulsion, adjuvant-related arthritis, and very rarely, chronic wasting disease.”

[3]According to the UCLA Office of Research Oversight, “Rabbits are the most commonly used laboratory animal species for polyclonal antibody production. Because of the inherent value of these experiments and the animals in which they are conducted, combined with the stress associated with these immunization protocols, specific-pathogen free rabbits must be used. These animals are readily available commercially and their use dramatically reduces the morbidity and mortality frequently documented in rabbits infected with microbial pathogens, especially Pasteurella multocida.”

Commercial suppliers of SPF rabbits used in antibody production include Charles River Laboratories and Covance Laboratories.

The book The Laboratory Rabbit, Second Edition (2010) by Suckow et al. states that, for polyclonal antibody production, “…it is advisable to use specific-pathogen-free-rabbits to minimize the risk of loss of valuable rabbits to infectious disease” (page 94).

Friday, August 21, 2015

Prior to the start of today's proceedings, attorneys representing both sides exited the hearing room to converse privately. After approximately 45 minutes to an hour, the parties reentered the hearing room, at which point, Judge Bullard announced that the hearing would be suspended and that September 30, 2015, is the last day for parties to file a status report about their position regarding the reinstatement of an ongoing hearing. Please note that a settlement was not reached and the hearing is scheduled to resume on April 5, 2016.

USDA Hearings Against SCBT: August 2016 (CANCELED)

The hearing which began on August 18, 2015, was suspended on its fourth day so settlement discussions could be pursued. At the end of September 2015, the USDA reported that the likelihood of a settlement was “remote” and requested a resumption of the hearing. The hearing, on the USDA's first and second complaints against SCBT, which was scheduled to resume on April 5, 2016, before Administrative Judge Bullard, has been postponed until August 15, 2016. Immediately following this hearing, another hearing, on the USDA's third complaint against SCBT, is set to begin.

This postponement, requested by SCBT and opposed by the USDA, is the fourth delay of proceedings against the company. In her March 18, 2016, order granting SCBT’s request, Judge Bullard wrote that she “agreed that the hearing should not be postponed indefinitely,” indicating the facility may have attempted to avoid setting a new hearing date altogether.

A chart, which shows the numerous delays of the USDA hearings against SCBT, can be seen here. Two of the four delays were described as attempts to reach settlement.

On May 19, 2016, a settlement agreement was reached between the USDA and SCBT, and therefore, the hearing was canceled. More information can be found here.