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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
Holmes By-Products, Inc. Enters Consent Decree with FDA
Company Agrees to Correct Manufacturing Deficiencies
The U.S. Food & Drug Administration (FDA) today announced that Holmes By-Products, Inc., Millersburg, Ohio, a renderer of bovine and poultry materials, and two of its officers, have entered a consent decree of permanent injunction due to significant violations of FDA's Ruminant Feed Ban (21 C.F.R. § 589.2000), discovered after consecutive inspections. The ruminant feed ban is an important safeguard against the establishment and proliferation of bovine spongiform encephalopathy (BSE), otherwise known as mad cow disease, in the United States.
The defendants have agreed to come into compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations through a combination of one or more of the following, as required by FDA's Ruminant Feed Ban:
- labeling products with the statement "Do not feed to cattle or other ruminants"
- maintaining separate lines of equipment for producing various products; and/or
- sufficiently cleaning existing equipment between uses.
Further, the consent decree provides for FDA to require a recall or shutdown in the event of future violations.
The consent decree was entered by Judge James S. Gwin in the U.S. District Court for the Northern District of Ohio on February 26, 2007.
To prevent the outbreak and spread of BSE, FDA published a regulation in 1997 prohibiting the use of most mammalian protein in the manufacture of animal feeds given to ruminant animals, including cattle, sheep, goats, deer and elk. Holmes By-Products, Inc. used common equipment to manufacture mammalian meat and bone meal and poultry by-product meal products without using a clean-out process adequate to avoid and prevent co-mingling and cross-contamination. Although these are significant violations of the feed ban regulations, no evidence was found indicating that this poultry by-product meal had actually been fed to cattle or other ruminants.
FDA reminds those businesses and individuals involved in the production, distribution and use of animal feeds and feed ingredients that if they are producing or using feed products for ruminants, and feed for other species that contains prohibited mammalian proteins, they must provide for adequate measures to avoid co-mingling or cross-contamination of these two types of products. Further, feed products that contain or may contain mammalian proteins prohibited from use in ruminant feed must be labeled with the caution statement "Do not feed to cattle or other ruminants."