Santa Cruz Biotechnology and the USDA

Speaking of Research have been troubled by the events which have unfolded at Santa Cruz Biotechnology (SCBT), including (but not limited to) the recent actions taken against the organization by the USDA. As an organization that strongly supports and advocates for the humane and responsible treatment of laboratory animals, Speaking of Research is critical of any organisation that does not meet its obligation to ensure the welfare of its animals, as well as any efforts to subvert the regulatory process. If the allegations against SCBT are true, their conduct is reprehensible. SR has written about these allegations in the past in the article’s “Santa Cruz Biotechnology: Dealing with Bad Behaviour” and “Caveat Emptor“. The following article is reprinted, with permission, from the American Physiology Society (images are not from the original article).

On May 19, 2016, antibody producer Santa Cruz Biotechnology (SCBT), Inc. reached an agreement with the USDA to resolve allegations of numerous Animal Welfare Act (AWA) violations. Under the terms of this agreement, SCBT neither admitted nor denied wrongdoing. Nevertheless, the company agreed that by May 31, 2016 it would pay a record $3.5 million fine. SCBT also agreed that as of May 31, 2016, it would cease antibody production involving USDA-regulated species and relinquish its registration as a research facility. SCBT also agreed to allow USDA to revoke its license as a dealer as of December 31, 2016, after which it can no longer sell antibodies made from USDA-regulated species.

Photo credit: Dan Coyro -- Santa Cruz Sentinel

Photo credit: Dan Coyro — Santa Cruz Sentinel

USDA filed three formal complaints against SCBT between July 12, 2012 and August 7, 2015 based upon the observations of inspectors from the agency’s Animal and Plant Health Inspection Service (APHIS) during multiple unannounced visits. The USDA complaints alleged that the company repeatedly violated the AWA in its treatment of goats used for antibody production. (For more about the USDA’s case against SCBT, see Caveat Emptor.) The complaints included allegations that SCBT failed to provide appropriate veterinary care to sick and injured animals; that its staff handled animals improperly; and that the company’s institutional animal care and use committee failed to ensure that animals were housed under appropriate conditions and that the animals’ pain and distress were minimized during antibody production. In its third complaint dated August 7, 2015, USDA also alleged that SCBT “demonstrated bad faith by misleading APHIS personnel about the existence of an undisclosed location where respondent housed regulated animals.” This “undisclosed location” was a barn where some 841 goats—including sick ones—were housed.

Top antibody suppliers in the US in 2012. Image from The Scientist

Top antibody suppliers in the US in 2012. Image from The Scientist

SCBT initially contested the USDA’s allegations and sought a hearing before an administrative law judge. After several delays, a hearing where both sides could present evidence case took place August 18–20, 2015 before Administrative Law Judge Janice Bullard. The hearing was suspended on the morning of August 21 with no explanation given. It was later scheduled to resume on April 5, 2016 and then postponed again until August 15, 2016.

The settlement agreement gives SCBT until the end of 2016—when its license will be revoked—to sell antibodies made from blood and serum it collected from regulated animals prior to August 21, 2015. However, SCBT had to stop producing antibodies from this blood and serum by May 31, 2016 when it agreed to cancel its registration as a research facility. Since the AWA does not regulate rodents bred for research, SCBT can continue to sell antibodies produced in mice.

Antibodies play an important role in both clinical medicine and research because they react to the presence of specific proteins. Antibody production starts by injecting an animal with a protein. This activates the immune system, which generates antibodies to identify the invading protein. Some types of antibodies are purified directly from blood collected from animals injected with a protein. Other types can be produced in a laboratory with cell lines created by fusing an initial batch of purified antibodies to harmless cancer cells. Antibodies target either one region of a protein (monoclonal antibodies) or several regions (polyclonal antibodies).

Why did the SCBT case take almost four years to settle? From a legal perspective, APHIS inspections findings represent allegations of AWA violations, and our system guarantees due process: Those accused of violating the law are entitled to their day in court. Kudos should go to USDA for its persistence in marshaling sufficient evidence to convince SCBT to agree to this settlement.

American Physiological Society

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