38 dead: Animal Welfare Institute criticises ‘Weak settlement’ in US CRO primate case

By Dani Bancroft contact

- Last updated on GMT

iStock/13160449
iStock/13160449

Related tags: Primate

The Institute claims SNBL USA has committed dozens of violations to the Animal Welfare Act and demands more severe consequences from the US Department of Agriculture.

Cathy Liss, president of the Animal Welfare Institute, said in a statement: “Given that this is the fourth enforcement action against SNBL, the USDA’s abdication of its responsibility to enforce the AWA is shameful and a major setback for proper enforcement of the law.”

Shin Nippon Biomedical Laboratories Ltd. (SNBL) was Japan’s first CRO, founded in 1997 with a subsidiary SNBL USA based in Baltimore, US.

The company’s operations based in Texas and Washington use non-human primates as part of their services while also importing, breeding, and selling the animals to other labs.

In a complaint​ submitted September 26 this year, a total of 38 monkeys have been reported to have died due to various incidents, including shipment from Asia to SNBL’s labs in Everett, Washington and Alice, Texas.

In response, the USDA has ordered a 30 day license suspension of the labs commencing December 22, along with a fine and series of scheduled inspections.

Previous incidents 

In a statement, the Animal Welfare Institute lists previous offenses to the welfare act, with penalty fines issued in 2006, 2008, and 2009 totalling $46,195.

In 2007​ a monkey was even “boiled alive in a cage washer at SNBL.”

Most recently – this November a USDA inspection​ uncovered that an infant macaque had died after being housed with a female macaque that was not its mother.

A settlement on the incident was reached on December 2 of this year, with the USDA ordering​ SNBL to cease and desist from breaches of the AWA, pay a $185,000 fine, and submit an inspection schedule – as opposed to typically non-scheduled visits.

The resulting settlement has been criticised as being too lenient on the firm, whose parent company – SNBL – has a net worth of more than $200m. Cathy Liss told Outsourcing-Pharma "The problems at SNBL USA are extremely serious and chronic, dating back to 2002."

Liss added "The breadth and depth of the citations by USDA inspectors suggest that significant, fundamental changes need to be made at the management level."

Efforts to improve welfare 

Back in 2012, SNBL USA was accredited for animal use in clinical studies by the AAALAC – Association for the Assessment and Accreditation for Laboratory Animal Care International.

AAALAC is a non-profit group which has assessments to maintain proper and humane treatment of animals used in laboratories.

The same year, SNBL invested to improve conditions following a 2010 FDA warning letter​. Changes made included improved animal enrichment​, staff training and a switch to automated control​ of humidity and temperature in the Everett labs.

“We take these allegations seriously and are fully cooperating with the USDA to ensure that we are in complete compliance. This is everyone’s priority,”​ said Steven Glaza – Executive VP of SNBL – in a statement to the Seattle Times​.

SNBL USA was not available for further comment.

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