4. Animal Proteins Prohibited From Use in Animal Feeds
The regulation in SEC 589.2000 (21 CFR 589.2000), prohibiting the use of certain animal proteins in ruminant feed, was published on June 5, 1997 (62 FR 30936). It was designed to prevent the establishment and amplification of BSE, through animal food, by prohibiting the use of certain proteins derived from mammalian tissue in the feeding of ruminant animals. This BSE regulation affects renderers, protein blenders, commercial animal food manufacturers, distributors (including retailers), transporters of animal food and ingredients, on-farm animal food mixers, and ruminant feeders.
On December 7, 2000, the USDA/Animal and Plant Health Inspection Service (USDA/APHIS) enacted regulations prohibiting the importation into the United States of all meat and bone meal (MBM), meat meal, bone meal, blood meal, tankage, offal, tallow, or any product containing such, which originated directly from countries identified as having BSE, or from countries having inadequate systems in place to prevent BSE (9 CFR 94.18 and 95.4). The prohibitions include all rendered products of animal origin including poultry meal and fishmeal that are processed in these countries, regardless of species of origin, unless the material is from a non-ruminant species and meets certain conditions assuring no contamination with ruminant material. These prohibitions were deemed necessary by APHIS because of the possibility of cross contamination with the BSE agent. Subsequently, on January 20, 2001, FDA issued Import Alert #99-25, "Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products for Animal Use Consisting or Containing Ingredients of Animal Origin" (Ref. 5).
On April 25, 2008, FDA published a final rule in the Federal Register , amending the BSE regulations to prohibit the use of certain cattle origin material in the food or feed of all animals (73 FR 22720). This final rule established new regulations entitled "Cattle Materials Prohibited in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy". The new regulation, SEC 589.2001 (21 CFR 589.2001), prohibits the use of certain cattle materials in the feed of all animals and is aimed primarily at rendering operations. This new rule also amended the BSE regulation in 21 CFR 589.2000.
FDA assesses compliance of the BSE regulations through the Agency's BSE/Ruminant Feed Ban Inspection Program (7371.009) (Ref. 6). This program is designed to assess an animal food facility's operational practices and procedures in preventing the spread of BSE through inspectional observations and sampling.
5. Medicated Feeds CGMP
Section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) provides that a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of the FD&C Act as to safety, and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.