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U.S. Department of Health and Human Services

Animal & Veterinary

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Animal By-Products Renderer Signs Consent Decree

by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No I

A consent decree of permanent injunction has been signed by the Food and Drug Administration and the president and vice president/general manager of Holmes By-Products Co., Inc., of Millersburg, OH, a renderer of bovine and poultry materials. The firm was found to be in violation of FDA’s ruminant feed ban (21 CFR Section 589.2000).

The ruminant feed ban, published in 1997, is an important safeguard against the establishment and spread of bovine spongiform encephalopathy (BSE) in the United States.

Holmes By-Products, Inc., and its officers have agreed to incorporate a combination of one or more of the following mitigation steps: label all of its products with the statement “Do not feed to cattle or other ruminants,” maintain separate lines of equipment for producing various products, and sufficiently clean existing equipment between uses. Under the terms of the consent decree, FDA retained permission to inspect the facility without prior notice to ensure continued compliance with the consent decree. In addition, the defendants agreed to pay the costs of all FDA inspections, investigations, and analyses that the agency deems necessary to ensure compliance.

The consent decree, which was entered on February 26, 2007, in the U.S. District Court for the Northern District of Ohio, also provides for FDA to require a recall or shutdown of the firm should violations occur in the future. Consecutive inspections of the Holmes operation by FDA officials showed that the company used common equipment to manufacture mammalian meat and bone meal and poultry byproduct meal products without using a clean-out process adequate to avoid and prevent commingling and cross-contamination. Although serious deviations from the ruminant feed ban were found, no evidence was found to indicate that this poultry byproduct meal had actually been fed to cattle or other ruminants.