Release No. 0218.05

STATEMENT BY DR. JOHN CLIFFORD REGARDING FURTHER ANALYSIS OF BSE TEST RESULTS IN WEYBRIDGE, ENGLAND

June 16, 2005

"Today, an official with USDA's National Veterinary Services Laboratory departed for Weybridge, England, hand-carrying samples for further testing.

"USDA's Animal and Plant Health Inspection Service (APHIS) has been consulting with officials at the Weybridge laboratory to discuss the conflicting results and the protocol for additional testing at Weybridge and USDA. Weybridge officials will be conducting a combination of rapid, immunohistochemistry and Western blot tests to determine whether or not this animal had BSE. USDA will also conduct additional analysis testing to better understand the conflicting results.

"Regardless of the final outcome of the tests on this animal, our interlocking safeguards worked to protect both animal and human health. The carcass of this animal was incinerated and therefore never entered the food or feed chain. In addition, public and animal health is protected by the ban on specified risk materials (SRMs) from the human food supply, along with FDA's 1997 regulations that prohibit the feeding of ruminant protein to ruminants.

"USDA has been conducting an enhanced surveillance program for BSE since June 2004. To date, we have tested more than 381,000 animals from the targeted population and all have tested negative for the disease, with the exception of the conflicting results from this sample. We look forward to receiving final test results on this sample from Weybridge."

Weybridge will conduct an IHC, OIE-prescribed Western Blot, a NaTTA Western Blot and a Prionics Western Blot rapid screening tests on tissue from this animal.

USDA will conduct a BioRad and IDEXX rapid screening tests and IHC tests. In addition, an OIE-prescribed Western Blot and DNA sequencing to determine the prion protein gene sequence of the animal will also be run.

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The following statement was posted by the OIG

(the link to that page follows the text):

USDA Office of Inspector General Statement on Audit Work Related to the BSE Test Result Announced on June 10, 2005 In August 2004, the Department of Agriculture’ s (USDA) Office of Inspector General (OIG) issued an audit report on USDA's BSE Surveillance Program-Phase I. (See OIG's website at:

http://www.usda.gov/oig/webdocs/50601-9-final.pdf.)

OIG made a number of recommendations to improve the Department's BSE Surveillance Plan in the Phase I audit report. Based on our audit findings, we recommended that USDA fully disclose the assumptions behind its sampling plan, clarify the limitations, and ensure that all high-risk animals are sampled and tested in accordance with USDA policy and the 2004 Surveillance Plan. We also recommended that USDA expedite development of a new system to track and report accomplishments, and implement performance measures and a continuous risk assessment.

Currently, OIG has two audits in progress pertaining to BSE. In our

BSE Surveillance Program-Phase II audit, OIG is monitoring the

Department 's implementation of its BSE Expanded Surveillance

Program, involving both APHIS and FSIS. This audit will evaluate the

following: the effectiveness of USDA's expanded BSE Surveillance program; the performance of BSE laboratories in meeting their objectives and complying with program policies and procedures for conducting tests on submitted BSE samples and reporting test results to APHIS and stakeholders; and the corrective actions taken by USDA in response to recommendations in the BSE Surveillance Program-Phase I audit report cited above.

In our Phase III audit, we are evaluating whether the USDA enforcement of the ban on specified risk materials (SRMs) in meat products and controls to prevent central nervous system (CNS) tissue in advanced meat recovery (AMR) product have been effectively implemented. The review also covers FSIS ante mortem condemnation procedures and procedures for obtaining brain tissue samples from condemned cattle for BSE testing.

In the course of reviewing voluminous records and information gathered

during the BSE Surveillance Program-Phase II audit, OIG auditors noted an unusual pattern of conflicting test results on one sample and initiated additional testing of that sample. As announced by USDA on June 10, the sample subsequently rendered a positive result under the OIE (World Organization for Animal Health) recognized SAF immunoblot test.

OIG's fieldwork on these audits is ongoing. Once the audits are

completed, OIG will report on the specific BSE Enhanced Surveillance Program issues and procedures we examined, our corresponding findings and recommendations, and USDA's response thereto. We anticipate completing and publicly releasing the reports late this summer.

 http://www.usda.gov/oig/webdocs/BSEStatement050615.pdf

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