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11 Plans of Action for Implementation _~1__ THAI By-- 4-- J OF lne HALUE system and of Microbiological Criteria for Foods and Food Ingredients IMPLEMENTATION OF HACCP Because the application of the HACCP system provides for the most specific and critical approach to the control of microbiological hazards presented by foods, use of this system should be required of industry. Accordingly, this subcommittee believes that government agencies re- sponsible for control of microbiological hazards in foods should promul- gate appropriate regulations that would require industry to utilize the HACCP system in their food protection programs. The regulations should identify the basic elements of the HACCP system and provide for ready availability of industry monitoring records that relate to critical control points and other appropriate information for review by regulatory inspection personnel. The regulations should not specify details of the application of the HACCP system. The development of such details should be the prerogative of industry. The regulations should require adequate training of regulatory inspection personnel in the elements of the HACCP system so that their inspection activities focus on the review of monitoring records as the primary basis for assessing the adequacy of a food processor's control program. The HACCP system should likewise be applied at points in the t-ood- processing chain other than at the processing level, i.e., in production, storage, transport, retail sales, and at food service establishments. Regulatory authorities should have the option of assessing the appro- priateness of selected critical control points, the adequacy of the moni- toring procedures and the actions taken when results of monitoring indicated the need for action. 329

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330 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA IMPLEMENTATION OF MICROBIOLOGICAL CRITERIA FOR FOODS AND FOOD INGREDIENTS. Introduction This subcommittee believes that for the most part microbiological cri- teria can best be used as one of the components of the HACCP system for food protection, e.g., as one of the means of monitoring critical control points in food processing and distribution (see Chapter 101. However, microbiological criteria can be used independently of HACCP as a sole determinant of the acceptability of a food or a process, e.g., through attribute sampling and testing of finished products domestically produced and/or at point of import for presence of Salmonella or of staphylococcal enterotoxins. In any event, whether or not microbiological criteria are applied either through the HACCP system or independently, there are principles governing their development and application that must be ad- hered to if the criteria are to be meaningful in the interest of food pro- tection. In the foregoing chapters of this report, the subcommittee has set forth these general principles. However, there is need for a plan of action that would be national in scope by which these general principles would be applied uniformly in the process of developing and implementing mi- crobiological criteria. Toward this end the following is directed. The Food Industry The subcommittee wishes to emphasize that application of the HACCP system by industry is the most effective means of assuring the micro- biological safety and quality of foods. However, it would be presumptuous to propose to industry the mechanism of a plan for development of mi- crobiological criteria either as an integral part of the HACCP system or otherwise. The needs for microbiological criteria are far too varied, even within a single organization, for any other than corporate management to undertake that task. It is anticipated, however, that the principles and considerations set forth in this report will provide guidance to those com- mercial organizations that need to use microbiological criteria in their food safety and quality control programs. Since it is industry's responsibility to provide safe food of acceptable quality, it should be industry's prerog- ative to design and implement the means by which such responsibility can be met to the satisfaction of regulatory agencies, or more broadly, the consuming public.

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PLANS OF ACTION 331 Government Agencies The primary purpose for use of microbiological criteria by regulatory agencies is to supplement other means they have of assuring that foods produced under their jurisdictions are safe and of acceptable quality (see Chapter 2) and to make certain that industry fulfills its responsibility. Since the processing and distribution of most foods fall under the regu- latory jurisdiction of many state and municipal agencies, as well as being subject to federal regulations, there should exist a high degree of uni- formity in the manner by which microbiological criteria (particularly those that pertain to finished product) are developed and implemented. Lack of such uniformity has resulted in the establishment of many criteria that are nonuniform, misapplied or unjustified, and highly controversial. Three examples will serve to illustrate: 1. The current state of microbiological criteria established by state agencies: Elsewhere (see Chapter 8) reference has been made to the surveys by Wehr (1982) of microbiological criteria for foods that currently are in effect in various states. Several observations im- mediately become apparent: (a) the great disparity among the states with respect to the foods for which microbiological criteria exist, (b) the variability of criteria applicable to the same food, (c) the impracticality of certain criteria, and (d) the large number of states that have not established microbiological criteria. The latter would seem to reflect indecision or indifference on the part of some as to the value of microbiological criteria in food protection programs. 2. The Oregon experience: Standards for fresh, frozen, and cooked or smoked meat products were promulgated by the state of Oregon in 1973. These standards did not fulfill the purposes for which they were established. They were unenforceable and created general ad- verse reaction. For these and other reasons, the standards were re- pealed in 1977 as "standards of quality, identity and composition." This unfortunate event caused confusion, ill will, and unwarranted costs. (For further discussion, see Chapter 9, part B.) 3. FDA's microbiological quality standards: FDA proposed to adopt microbiological criteria (under Section 401 of the Food, Drug and Cosmetic Act) designated as "standards of quality for foods for which there are no standards of identity" (see Chapter 21. This was an approach to expanding the agency's use of microbiological cri- teria. The proposal resulted in predominantly adverse reaction, as amply documented in the Federal Register and other publications. The standards were not purported to bear any relationship to safety.

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332 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA Quality standards for four types of cream-type pies and food-grade gelatin were adopted but later, for various reasons, were withdrawn. However, FDA stated its intention to promulgate microbiological quality standards for other foods. Subsequently, due to lack of "suf- ficient resources to promulgate and enforce additional microbio- logical quality standard regulations," the agency stated its intention to "issue microbiological quality standards as recommendations or regulations as appropriate" and encouraged voluntary adoption by industry and state authorities of standards developed and recom- mended by the agency. Accordingly, standards for three seafood products (frozen fish sticks, fish cakes, and crab cakes) were rec- ommended for adoption. The standards were based upon the results of national surveys of products obtained at retail outlets. At least 47 such product surveys have been made. However, to date no additional recommendations of microbiological quality standards have been issued. For further discussion of FDA's program for microbio- logical quality standards see Chapter 2. Recently, FDA proposed microbiological defect action levels (pre- sumably standards) for raw breaded shrimp (FDA, 1983~. Comments on the proposal were invited. The criteria are based on the results of surveys at the plant level of 31 breaded-shrimp processors. Thus, the approach to the development of the microbiological defect levels was quite different from that used for the microbiological quality standards. In retrospect, the turbulent history of FDA's attempt to promulgate microbiological quality standards leads to the conclusion that the effort has fallen far short of success. As for the proposed micro- biological defect action levels, any conclusion as to success or failure is premature at this time. In any event, the approach taken by FDA to expand its use of micro- biological criteria was unilaterally conceived and pursued. In the early planning stages for the development of microbiological criteria there was little input from the various segments of industry, other federal agencies, state and municipal agencies, or others having a vital interest in any such undertaking. Had the agency enlisted these groups in the early planning stages in a coordinated effort, it is likely that needs for criteria would have been clearly delineated and justified and that chances for emergence of a successful program for an expansion of FDA's use of microbiological criteria for food would have been greatly enhanced. There are excellent examples of successful multilateral programs that have been established in response to national needs relative to food safety.

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PLANS OF ACTION 333 Notable are the Cooperative Federal-State Program for Certification of Interstate Milk Shippers, the 3-A Sanitary Standards Program for sanitary design and operation of dairy equipment, the National Shellfish Sanitation Program (see Chapter 8), and the current good manufacturing regulation for low-acid canned foods. Also, the National Cooperative State/Federal Programs for the Eradication of Brucellosis and Tuberculosis in Cattle (see Chapter 4) were developed with broad participation of all concerned with the need for control of these diseases of cattle. It is emphasized that especially in the development of the milk and shellfish programs, the 3-A Sanitary Standards and the low-acid GMPs, industry's participation was extensive. Much of the technical competence needed was provided by industry, and its voice was as influential as any in regard to regulatory requirements that were established. It seems abundantly clear that the magnitude of the impact of the im- plementation by regulatory agencies of microbiological criteria for foods that would apply nationally would demand widespread participation by concerned groups in the development of the criteria. Such participation would tend to assure that the best interests of all were served and that general acceptance of the criteria would be forthcoming. It is logical that concerned federal agencies assume leadership in fostering a multilateral approach to development of microbiological criteria for foods. In fact, it is evident from the survey by Wehr (1978) that a preponderance of re- sponses (50 of 64) received from states stated a preference for federal agencies to assume such leadership. In view of the considerations given above, this subcommittee offers a plan for a national program for identification of foods for which micro- biological criteria are needed, for development of criteria for those foods, and for appropriate implementation of such criteria in regulatory programs. THE PLAN 1. The Bureau of Foods of the Food and Drug Administration, an appropriate subsidiary body of the Department of Agriculture, the National Marine Fisheries Service, and the U.S. Army Natick Re- search and Development Center, being the primary federal agencies having the responsibility of assuring that foods available to their constituencies are safe and of acceptable quality, jointly should es- tablish an ad hoc Commission on Microbiological Criteria for Foods. 2. The objective of the commission should be to develop microbio- logical criteria for foods that will be responsive to need. 3. The Food and Drug Administration, having the broadest responsi

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334 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA bility for food protection among the federal agencies, should take the initiative to arrange with the cooperation of the other three agen- cies identified above for appointment of members to the commission. 4. Membership of the commission should consist of appropriate per- sonnel selected from (a) each of the four above-mentioned federal agencies, (b) state and municipal food regulatory agencies, (c) the food industry, and (d) academia. The number of members on the commission should be kept to a minimum in the interest of expe- diency in reaching decisions and economy of operations. 5. Initially, the commission should address (a) the selection of foods and food ingredients on the basis of need for microbiological criteria that could effectively supplement and be incorporated in food pro- tection programs of federal, state, and municipal food regulatory agencies (The selection process should include, but not be limited to, a review of foods for which criteria currently exist and an eval- uation of the suitability of these criteria.), and (b) the development of criteria for each food for which it was determined that micro- biological criteria would serve a useful purpose. 6. The commission should appoint expert working groups to carry out the tasks of selecting foods and of development of criteria. The expert working groups should present their recommendations to the . . commission. The commission should present its recommendations to the federal agency having primary jurisdiction for the safety and quality of the food or food ingredient involved. The federal agency should take the necessary steps to promulgate regulations embodying the rec- ommended criteria and to promote uniform adoption of the criteria by state and municipal regulatory agencies if it deems it appropriate to do so. Insofar as possible, the Department of Defense should utilize microbiological criteria recommended by the commission in developing military specifications for foods and food ingredients. The development, review, and modification of microbiological cri- teria for foods is a continuing task. Therefore, as soon as the initial work of the commission has been set in motion, it should take the steps necessary to organize itself as a continuing body elected by vote or other suitable means of the participating groups indicated above, except that the representative of each federal agency should be appointed by an appropriate official of the respective agency. The subcommittee also suggests that the organizational structure of the several cooperative federal/state programs mentioned above be reviewed for guidance in this task. 9. Finally, the commission should address the continuing need for

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PLANS OF ACTION 335 research to (a) better understand the effects of current and emerging processing and distribution practices that may affect the microbial safety and quality of foods, and (b) improve and develop methods for the detection and enumeration of microorganisms and groups of microorganisms and their toxic agents that are important to the safety and quality of foods. This subcommittee believes that the plan of action for implementation of the HACCP system provides for the most specific and critical approach to the control of microbiological hazards presented by foods. The plan of action for implementation of microbiological criteria that embodies the general principles and considerations presented in this report will lead to a coordinated national program for the establishment and application of microbiological criteria for foods that will enhance food protection pro- grams of federal, state, and municipal agencies as well as those of the military and of industry. The subcommittee recommends that action be taken to implement these plans at the earliest opportunity. REFERENCES FDA (Food and Drug Administration) 1983 Raw breaded shrimp: Microbiological defect action levels. Federal Register 48(175):40563-40564.Sept. 8. Wehr, H. M. 1978 Attitudes and policies of state governments. Food Technol. 32(1):63-67. 1982 Attitudes and policies of governmental agencies on microbiological criteria for foods- an update. Food Technol. 36(9):45-54, 92.

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