Feed Establishment Inspections

A. Background The Medicated Feeds Program has been implemented with the assistance of the states under contract since 1973. For the last several years states have accomplished surveillance inspections to determine whether firms manufacturing medicated feeds were in compliance with key good manufacturing practices (GMP) regulations. The Second Generation Medicated Feed Regulations, published by the FDA in 1986, set forth revised requirements concerning approval procedures for the manufacture of animal feeds containing new animal drugs. These regulations focus on highrisk drugs, i.e., carcinogens and drugs requiring withdrawal times at their lowest use level. Firms using Category II Type medicated articles to make medicated feeds are required to register with FDA and hold approved licenses. FDA is required to inspect these firms once every two years. FDA's Center for Veterinary Medicine (CVM) uses the Current Good Manufacturing Practices (CGMP) inspection classification to determine the approval decisions for pending license applications. Classification of OAI will result in recommendations to refuse license approvals, while NAl and VAl classifications will not. An OAI classification for a licensed firm may start the process to withdraw the license. On June 5, 1997, FDA published a final rule prohibiting the use of mammalian protein in ruminant feeds. This action was taken to prevent the spread of bovine spongiform encephalophy (BSE) in the United States; thus, the phrase "BSE rule" to describe it. The rule, which is codified in 21 CFR 589.2000, provides for labeling, record keeping and clean out requirements for renderers, feed manufacturers, haulers of feed, and producers. B. Objectives: This contract is designed to obtain state assistance in the inspectional coverage of feed establishments, specifically: 1. To conduct inspections of licensed feed establishments to determine compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and State feed law (if the contractor's feed law has the provisions of the current AAFCO Uniform State Feed Bill) . 2. Assuring compliance with 21 CFR 589.2000 by the licensed and non-licensed feed establishments. 3. To encourage voluntary corrective action by the establishment when appropriate. 4. To furnish the FDA with reports of inspections and sample examinations accomplished under the contract. Reports on any compliance follow-up and corrections achieved by the contractor under its own program will also be submitted.