• All testing is undertaken in government-certified labs or independent research facilities

• The European Commission has approved the BioRefinex™ porcess for Category II and III animal by-product processing and Category I (TSE's) validation tests have been completed at the Roslin Institute, Edinburgh, Scotland

• The Canadian Food Inspection Agency has issued a "negligible" risk rating for BioRefinex™ processing SRM material, with no further restrictions on the industrial use of the hydrolyzed output material.

Roslin Institute, Edinburgh, Scotland - TSE Inactivation Tests

A multi-year test project was undertaken by the Neuropathogenesis Division of the Roslin Institute under the direction of Dr. Robert Somerville, with Dr. David Taylor as Scientific Advisor. Publication of the final report is scheduled for the Spring of 2009. Following is the Abstract from the report.

“The infectious agents causing transmissible spongiform encephalopathies (TSE's), sometimes called prions, are notoriously difficult to completely inactivate or destroy. Here we tested a thermal hydrolysis system which combines saturated steam heating to 180 °C (10 Bar), with stirring. The 301V-TSE strain, which has been derived by passage of BSE in mice, was used since it is the most thermostable TSE strain tested so far. All detectable TSE infectivity was destroyed, with a clearance factor of greater than 105 ID50.”

CLICK HERE for Full manuscript available in Process Biochemistry 44 2009 (1060-1062)

Dr. David Taylor, Dr. Karen Fernie examine test material		Research team (left to right); Dr. Allister Smith, Dr. Erick Schmidt, Dr. Karen Fernie, Dr. Robert Somerville, Randall Andrews

 

Canadian Food Inspection Agency (CFIA) Protocol
Government of Canada - Ottawa

The following is an excerpt from the CFIA: http://www.inspection.gc.ca/english/anima/heasan/man/bseesb/4e.shtml

4.9 Thermal Hydrolysis

Background

1. Specified risk material (SRM) is regulated from its point of origin (kill site) until it is destroyed or disposed. This includes the permitting and inspection of all handling, processing and destruction steps.

2. The CFIA Science Directorate performed a risk assessment on thermal hydrolysis of SRM and determined that, using specific operating parameters, the resulting material discharged at the end of this process presents a negligible risk of transmission of bovine spongiform encephalopathy (BSE) to domestic ruminants. Therefore, thermal hydrolysis is an acceptable method of permanent destruction of abnormal prions that may be present in SRM and is approved by the CFIA as a destruction method.

3. Based on the conclusion of this risk assessment, output products from approved thermal hydrolysis installations are not subject to further SRM regulatory controls. Depending on their form and intended use, output products remain subject to all other relevant federal legislation as well as all relevant provincial and municipal regulatory requirements.

4. CFIA-approved thermal hydrolysis of SRM requires operation at 180°C and 1200 kPa for a period of not less than 40 minutes per cycle in an enclosed pressure vessel that is suitable for the purpose required.

5. Note that the European Union (EU) standard operating conditions for thermal hydrolysis processing of SRM have not been directly adopted in Canada.
The EU standards specify the following:

• All solid or semi-solid material shall be ground, cut or reduced to a maximum dimension of 50 mm prior to charging into an approved thermal hydrolysis vessel for TSE (SRM) destruction.

• The thermal hydrolysis process is capable of destroying whole intact carcasses, negating any requirement for particle size reduction prior to charging into the process vessel. In the course of the processing cycle, the material is rapidly ground to a small particle size, thus achieving the same effect as particle size reduction.