Researchers work to stop mad cow threat

Researchers work to stop mad cow threat

June 29, 2001 United Press International by Kurt Samson

Researchers are studying ways to remove the threat that bovine gelatin contained in European food and drug products could be contaminated by agents that cause mad cow disease.

A special advisory panel of the Food and Drug Administration was updated Friday on progress toward developing an effective way to inactivate the agents that cause bovine spongiform encephalopathy-BSE or mad cow disease-and a similar human disease called new variant Creutzfeldt-Jakob disease, or nvCJD, from gelatin food and drug products before they enter the United States.

John Bailey, with the FDA's Center for Food Safety and Applied Nutrition, said the agency "intends to monitor gelatin products very closely" but added that-until an eradication process is proven-it remains wary of European products. The United States has barred such imports from countries where cases have been confirmed. The risk of contamination from those countries to neighbor nations which still provide gelatin to the U.S. market also has drawn FDA concern, said Dr. Stephen Nightengale, executive director of blood safety at the Department of Health and Human Services.

Since 1996, evidence has been increasing for a causal relationship between BSE and nvCJD, he said, but fortunately no cases have been reported in the U.S.

"Both disorders are invariably fatal brain diseases with unusually long incubation periods measured in years, and are caused by an unconventional transmissible agent called a prion," he said.

The first outbreak of BSE occurred in Great Britain in 1986 and since then, about 95 percent of cases have occurred in the United Kingdom. The disease also has been confirmed in native-born cattle in other European countries such as Belgium, France, Germany, Spain and Switzerland. Michel Schoentjes, vice president of the Gelatin Manufacturers of Europe, headquartered in Brussels, said about 30 percent of the gelatin used for human consumption in Europe is derived from bovine raw material and GME members have taken "extreme care" to make sure that bovine gelatin is and remains a product that can safely be used for edible or pharmaceutical products.

As has always been the case, only raw material from healthy slaughtered animals is used and suppliers are obliged to certify that in supply contracts. As of June 1, 2000, the European Union regulation for edible gelatin made such certificates generally mandatory within the EU and for imports from third countries.

"In the case of bovine bones, GME members have for years voluntarily excluded the use of specified risk material," Schoentjes said. "They sorted out skulls from ruminants and have removed spinal cords."

The GME also has commissioned studies to prove effective removal and inactivation of potentially present contaminants of nervous tissue, in the event an infected animal has entered the raw material supply chain undetected. To complement these earlier results, GME has new studies in progress on the removal/inactivation of BSE infectivity.

Robert Rohwar, director of the molecular neuro-virology unit at the Veterans Administration Medical Center in Baltimore, Md., presented preliminary results from similar U.S. studies FDA is sponsoring to find ways to inactivate BSE during production.

"This is a work in progress," he told the panel. "Gelatin is used pervasively not only in pharmaceuticals but also in foods and GME supplies 45 percent of the world's gelatin market."

He said research efforts include soaking bovine bone chips contaminated with BSE in alkaline solutions and hydrochloric acid for a number of days, which has yielded some positive results but not full decontamination. An even more promising technique involves exposing the bone chips to ultra-high temperatures similar to those used in the pasteurization process of box milk that needs no refrigeration.

"Surprisingly, steps to filter the resulting gelatin through an ion exchange purification system removed no more of the agent," he said. "But baking the bone at 140 degrees got significant clearance."

The panel will meet again in August to review the study's progress.

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