Bovine Spongiform Encephalopathy (BSE) News Update

Single Isolated Case: Non-Ambulatory Dairy Cow Slaughtered in Washington State Confirmed BSE Positive by the BSE World Reference Lab in Weybridge, England ~ December 25, 2003

Life Technologies' commitment is to our customers!  We are working closely with the USDA and other regulatory agencies, monitoring the progress of the situation as it changes.  Our Gibco® Cell Culture team is an integral partner addressing this issue directly with our customers.  Providing Continuity of Supply, Alternative sera sources and / or products based on their needs and requirements are examples of that commitment.

Life Technologies’ current position is that we will monitor and follow the guidance provided by the United States Department of Agriculture and / or the United States Food and Drug Administration regarding Fetal Bovine Serum and related products.  At this time we are concluding that no existing products in possession by our customers or in salable form in our inventories are affected by this isolated incident and we will continue to supply FBS to our customers.

Should you have any additional questions please contact Life Technologies Cell Culture Technical Support at 1-800-955-6288


USDA Chronology of Events: BSE Case

References


Safety & Inspection Notice: This notice was issued to all veterinary medical officers (VMO) to reinforce that they pay particular attention to cattle showing signs of central nervous system disorders.

All VMOs in plants slaughtering adult cattle should remain especially aware of cattle showing signs of central nervous system disease.  For BSE surveillance adult cattle are considered to be animals that are 20 months old or greater. As a matter of fact, all livestock presented for ante-mortem inspection displaying signs of a central nervous system disease or disorder are condemned, and the appropriate officials from the Animal and Plant Health Inspection Service are notified immediately.  Condemned materials are not brought into the slaughterhouse.

BSE infected cattle experience progressive degeneration of the nervous system and may display changes in temperament, abnormal posture, in coordination, decreased milk production, or loss of body weight.  There is currently no validated test to detect the disease in a live animal.  Veterinary pathologists confirm BSE by histopathologic and immunohistochemical examination of brain tissue.

Please note that all cattle undergo ante and if not condemned, post-mortem inspections per 9 CFR parts 309 and 310.

Minimizing Risks Bovine serum is listed as a Category IV material by the EU Monograph entitled "Minimizing the Risk of Transmitting Spongiform Encephalopathy Agents Via Medicinal Products" and thus is considered to have "no detectable infectivity."

Animal Risk Analysis
A second risk assessment, commissioned in May of 2003, was conducted by the Harvard Center for Risk Analysis and confirmed the findings of the initial study released in 2001.  The study found that even if infected animals or ruminant feed material entered the USA animal agriculture system from Canada, the risk of its spreading extensively within the USA herd was low, that any possible spread would now have been reversed by controls put in place in the late 1990's, and that eventually, the disease would be eliminated from the USA.