Compliance Program 7367.004 - Medicated Premixes and Feeds: Illegal Residues in Compliance Policy Guide 7125.07 of CGMPR Violations on NADA - Impact Memorandum dated May 29, 1973, to R. T. Hunt REPORT OF THE MEDICATED FEED TASK FORCE EXECUTIVE SUMMARY On June 7, 1978, the Director of the Bureau of Veterinary Medicine (BVM) and the Associate Commissioner for Regulatory Affairs advised the Commissioner of Food and Drugs of the formation of a Medicated Feed Task Force to examine the existing medicated feed program and to explore and recommend ways to employ resources more efficiently in this program. (See Tab A.) Actions were taken to The existing program is the result of piecemeal development to implement the 1968 Animal Drug Amendments pertaining to medicated feeds, to keep within the resource limitations of the Agency, and to deal with problems as they arose. resolve immediate problems that were not necessarily consistent with other requirements of the program. Such ad hoc development has resulted in a program that lacks adequate coherence, direction, and support. Thus the current program consists of a random assortment of requirements that may or may not compliment one another and vary in their relation to the public health protection purposes of Section 512(m) of the Food, Drug, and Cosmetic Act. The Task force utilized a wide spectrum of resources and evaluated many suggestions in arriving at its recommendations. There Input was obtained from individuals involved in various aspects of the Medicated Feed Program in FDA headquarters and field offices; state feed officials; and representatives of the livestock, poultry, drug and feed industry associations. were nine full day meetings with FDA personnel and state representatives, six full day meetings with trade associations and industry representatives, and 12 Task Force work meetings. (Minutes of meetings are in Tab B.) The report describes current practices, identifies problems, recommends solutions, and suggests implementing mechanisms. The Task Force report sets forth the recommendations without a discussion of all the suggestions made to the Task Force or the pros and cons of the recommendations (Tab B). The Task Force believes adoption of the recommendations will result in more effective and efficient utilization of resources and will re-establish the medicated feed program on a more rational and functional basis. The Task Force recommendations focus on the objective of maximizing public health protection by orienting the medicated feed program to the human risk potential of medicated feeds. Control is strengthened where the potential risk is greatest and lessened where the risk is minimal. The potential risk assessment of existing drugs in the forthcoming Federal Register notice on drug carryover in medicated feeds provides the basis for a categorization of drugs in medicated feeds at specified levels and by feed type. The Task Force recommends that the categories be used to specify which medicated feeds do or do not require approved medicated feed applications based on the human risk potential. Under this approach, there will be a significant reduction of the number of medicated feeds subject to FD-1800 approval. Furthermore, we recommend provision for generic medicated feed applications for the proposed Type C and D medicated feeds. The Task Force recommends a preapproval inspection program, since the application approval process will be applied on a human risk assessment basis. The manufacturers of medicated feeds not requiring approved applications would be exempted from drug registration and the biennial inspection obligation, significantly reducing the inventory of firms which are inspectional obligations. The state inspection contractural program should be strengthened to require adequate quality of inspections for FDA regulatory purposes. States incapable or unwilling to meet FDA criteria and standards would be dropped from the program. The proposed program will require an initial increase in resources for training and inspection over an estimated 3-year period to implement the proposed program. The inspectional obligation would subsequently stabilize at a level significantly lower than existing currently. The number of FD-1800's processed by BVM would be reduced by an estimated 50 percent. We believe the impact of the proposed program would be more efficient and effective use of resources under a more rational public health posture for both the goverment and industry. The recommendations of the Task Force are extensive and may be considered a new generation and approach to medicated feed regulation. This is an approach in which the Agency's limited resources in the medicated feed program would for the first time be expended in enforcing those requirements that are of maximum benefit in public health protection. While the recommendations are severable and cannot be implemented simultaneously (some require informal rulemaking proceedings) the Task Force recommends that they be considered in their entirety, since all the recommendations are interrelated and all are required to implement a new comprehensive and cohesive medicated feed program. 42-355 79 - 6 |