SAEN got their goats: Santa Cruz Biotech put out of animal lab work
Media Coverage About SAEN Stop Animal Exploitation Now


SAEN got their goats: Santa Cruz Biotech put out of animal lab work
By Merritt Clifton, Animals, May 22, 2016

USDA-APHIS case settlement comes after Santa Cruz Biotech was caught allegedly hiding goats from inspection

Santa Cruz Biotechnology Inc., a major producer of antibodies, was on May 19, 2016 fined $3.5 million and appears to have agreed to abandon working with live animals.

Santa Cruz Biotech was in 2012 notoriously caught allegedly trying to hide 841 goats from the USDA Animal & Plant Health Inspection Service to conceal violations of the Animal Welfare Act.

May go to non-animal methods

Yale University pathologist David Rimm suggested in February to Sara Reardon of Nature that Santa Cruz Biotech may be following much of the rest of the antibody industry “toward making ‘recombinant’ antibodies. These are produced in cells cultured in the lab,” Rimm said, “that are genetically engineered to make specific antibodies.”

Announced USDA-APHIS, “The consent decision,” in effect a plea bargain, “provides that Santa Cruz Biotechnology, Inc. is not admitting or denying that it has violated the Animal Welfare Act, and contains an order that includes a provision to cease and desist from violating the Animal Welfare Act, assessment of a $3.5 million civil penalty, revocation of its dealer’s license effective December 31, 2016, and agreement to submit a letter to cancel its research registration by May 31, 2016.”

Biggest fine ever

Said Stop Animal Exploitation Now cofounder Michael Budkie, who had investigated and exposed alleged Animal Welfare Act violations by Santa Cruz Biotech since 2008, “The penalty is the largest in the history of Animal Welfare Act enforcement.”

The consent agreement settled USDA-APHIS complaints filed against Santa Cruz Biotech in July 2012, November 2014, and August 2015.

Last legal shots

But those were just some of the last legal shots in a very long battle. While the USDA-APHIS complaints were in the slow process of negotiated settlement, SAEN and the Animal Legal Defense Fund in January 2013 asked Santa Cruz County Court for a permanent injunction ordering Santa Cruz Biotech to cease violating the federal Animal Welfare Act by allegedly neglecting goats used to produce antibodies.

The lawsuit was filed three days after the Animal Welfare Institute asked Agriculture Secretary Tom Vilsack to revoke the Santa Cruz Biotech permits to deal in live animals, and asked National Institutes of Health director Francis Collins to require Santa Cruz Biotech to submit a statement of compliance with the Animal Welfare Act as a condition for supplying antibodies to NIH-funded researchers.

Goats came to light

The many cases against Santa Cruz Biotech gained momentum after the USDA-APHIS learned that the company had since 2009 kept 841 goats at a separate site, nine miles from the company’s licensed animal housing. This separate site had never been inspected by USDA-APHIS because the company had not told the USDA-APHIS that the facility existed.

The hidden goats came to light, the journal Nature reported in February 2015, through whistle-blowing by former Santa Cruz Biotech veterinarian Robin Parker.

“During the August 2015 USDA hearing,” Nature summarized, “Parker testified that company president John Stephenson had decided not to tell the USDA inspectors about the second site. She said that she had been told that the regulators tended to ‘nitpick’ the company’s operations.

All animals disappeared

“After leaving Santa Cruz Biotech in 2012,” Nature continued, “Parker notified the USDA about the unreported facility. When inspectors visited the site, they found animals housed in poor living conditions.”

Meanwhile, Nature said, as the Santa Cruz Biotech case crawled toward resolution, “The company seems to have done away with its entire animal inventory. When the USDA inspected the firm’s California facility on 12 January, it found no animal welfare violations — and no animals.

“The fate of the goats and rabbits is unclear. The company did not respond to questions about the matter, and David Schaefer, director of public relations for the law firm Covington & Burling in Washington DC, which is representing Santa Cruz Biotechnology, declined to comment on the animals’ fate.”

Untreated wounds & tumors

The USDA-APHIS complaints about Santa Cruz Biotech described alleged Animal Welfare Act going back in some instances to 2007, including accounts documented by photographs of goats having been left to suffer with untreated coyote bites and large tumors, “and rabbits being housed in cruel conditions,” Nature summarized. “A sick goat died in front of a USDA inspector during one 2012 inspection.”

Budkie and PETA researcher Jeremy Beckham were skeptical that Santa Cruz Biotech had actually divested of live animals.

Animals again hidden?

“I think this is a misunderstanding of APHIS online ACIS system,” Beckham posted in response to the Nature article. “The USDA told me that the numbers reported along with the inspection are only those that the inspector physically laid eyes on––it does not mean those are all the animals in that facility’s possession.”

Added Budkie, “I saw that January inspection report and ignored it as having any conclusive findings. That was my take on it, too, that it could mean no animals were inspected. SAEN initiated this Santa Cruz Biotech case back in 2007/08,” Budkie said. “We follow this case very closely. Only when the USDA’s case against Santa Cruz Biotech escalated did other groups jump on it.”

SAEN pushed case since 2008

“SAEN exposed this starting back in 2008,” affirmed SAEN cofounder Karen Budkie. “Michael in the beginning of our campaign kept saying that no one else was even bothering with Santa Cruz Biotech because it was goats, not the animals people identify with. Not until we kept pushing the USDA to take action, which they did, did other groups even bat an eye at it.”

The earliest indication in the ANIMALS 24-7 files of other animal advocacy organizations being involved in the Santa Cruz Biotech case was a September 20, 2012 media release stating that “The Humane Society of the United States applauds the U.S. Department of Agriculture’s recent filing of a formal complaint against animal research facility Santa Cruz Biotechnology after a series of Animal Welfare Act violations. This complaint, filed with an administrative law judge, signals that the USDA has deemed the laboratory’s violations to be willful and rising to the level of formal penalty.”

Pi Bioscientific

Meanwhile, Budkie told ANIMALS 24-7 on April 14, 2016, “We have found another place that is just as bad,” naming Pi Bioscientific, also known as Pi Biologique, of Seattle.

USDA-APHIS inspection reports, SAEN summarized in a media release, “document dozens of research animals denied veterinary care, falling-down facilities––and 18 animals whose disappearance cannot be explained.”

SAEN alleged that “Pi Bioscientific has now amassed 17 citations for violation of federal law in just four inspections over the last two years, with two inspections each containing seven citations. During the last nine months,” SAEN said, “only one U.S. research lab has had an inspection with more than seven citations.”

Inadequate staff

Concluded USDA-APHIS in a March 2016 inspection report, “Based on the numerous medical ailments and severe health issues observed in the goats on this inspection, the research facility does not have an adequate number of staff to provide care for the animals. In addition, based on the extremely poor state of sanitation of the goat/sheep barn and the repairs needed for barn and the outdoor shelters in the pasture, the research facility does not have adequate staffing for cleaning and maintenance.”

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