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6 FDA Veterinarian 1 (1991)

handle is hein.animal/fdavt0006 and id is 1 raw text is: JO.q m FDA ISSUES REVISED MEDICATED FEEDS COMPLIANCE PROGRAM F DA's Medicated Feeds Compliance Program has been revised for Fis- cal Year 1991 based on the results of a comprehensive review process in- itiated in Fiscal Year 1989. Some sig- nificant changes made in the program are presented below. Current Good Manufacturing Prac- tices (CGMP) inspection results for feed mills will no longer be expressed as pass/fail. Feed mills with inspection results that indicate deviations from CGMP's in ways that can be corrected voluntarily will be classified as volun- tary action indicated (VAI) and will be asked to correct the deficiencies. Pend- ing and future medicated feed applica- tions (MFA's) will be approved for VAI- classified mills. However, mills with more serious CGMP deviations (classi- fied as Official Action Indicated) will not be granted approval for MFA's. These mills will be given written notice that they will lose their authority to manufacture any feed using Category II Type A Medicated Articles, if correc- tions are not made within a reasona- ble time. Another major change is the inspec- tion priority. Priority 1 is the re- inspection of mills in which most recent inspections were classified Official Ac- tion Indicated (OAl), or violative. Re- inspection of the OAI mill should occur within 90 days of issuance of a letter to the mill. Priority 2 is pre-approval in- spection for mills applying for MFA's for the first time. This inspection should take place before an MFA can be ap- proved, and should occur within 60 days of the filing of the MFA. Priority 3 is the routine biennial CGMP inspec- tion of mills where the most recent in- spections were nonviolative. By Karen Kandra More stringent administrative/regula- tory sanctions are anticipated with the new program. Following the first in- spection classified OAI, the mill will be sent a letter signed by the District Director advising that: 1 ) approval of all pending and future MFA's will be refused until the CGMP deviations are corrected, and 2) the letter constitutes official notice of CGMP violations as required un- der Section 512(m)(4)(B)(ii) of the Federal Food, Drug, and Cosmetic Act. If the CGMP re-inspection is also violative (i.e., classified OAI), the Dis- trict will recommend that the Center is- sue a notice of opportunity for a hear- ing (NOOH) proposing withdrawal of the mill's approved MFA's. Regulatory (Continued, next page) PORK QUALITY ASS lfM By Ruth Reardon T he National Pork Producers Coun- cil has developed a new multilevel management education program called the Pork Quality Assurance Pro- gram. The program will help producers avoid illegal drug residues, improve management skills, and reduce production costs. There are three levels in the program. Level I provides basic information about I usage, withdrawal times, ad owo avoid residue problems. A o ion hogs raised by E& rs are now enrolled in rogram. Level II focuses on good management concepts and in- cludes a self test. More than 1,000 producers have completed Level II. Level III includes materials for a producer to verify his safe residue sta- tus by checking hogs and facilities, and taking a management exam. To date, 38 producers have completed Level Ill. By the end of 1991, the National Pork Producers Council hopes to have 23,000 producers enrolled in the program. Today's consumer wants a safe and wholesome product. This program is designed to communicate to the consumer the pork industry's desire to produce that high quality product. The following is a description of the three levels of the Pork Quality Assurance Program. Level / Animal drugs are used for preven- tion of disease and promotion of ani- mal health, for increased efficiency by (Continued, next page) In This Issue: Salmonella in Animal Feeds . .. 4 Extension Veterinarians and the Extension Service ...... 5 CVM Holds Feed Safety Symposium ............. 9 CVM's Role in Food Biotechnology Regulation . 10 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE 71 January/February 1991 Vol. VI, No. I FDA VETER[NARL4AN

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