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8 Current Status of Microbiological Criteria and Legislative Bases INTRODUCTION Early Programs in the United States Some of the initial intensive efforts directed at the control of bacteria in processing and storage were focused on fluid milk and other dairy products because of the role these foods played in foodborne disease transmission. The milk sanitation program is one of the oldest in the Public Health Service; the initial ordinance was developed in 1924 as a model regulation for voluntary adoption by state and local milk control agencies (USPHS, 1924~. An accompanying code provided administrative and tech- nical details on satisfactory compliance (USPHS, 19271. Microbiological criteria were included in these original regulations. Periodic revisions followed as improvements in technology for the pro- duction and transport of raw milk and for the processing, packaging, and storage of pasteurized milk products occurred. Each of the revisions was developed with the assistance of milk sanitation and regulatory agencies at the federal, state, and local levels and with other segments of the dairy industry. These early efforts led to the current programs. The Grade A Pasteurized Milk Ordinance, 1978 Recommendations, of the U.S. Public Health Service, Food and Drug Administration (USPHS/FDA, 1978), the most recent revision, was produced with substantial assistance from the National Conference on Interstate Milk Shippers (NCIMS) and was im- plemented in 1980. The chemical, bacteriological, and temperature stan- dards in this revision are presented in Table 8-1. Recognition of the public health problems associated with shellfish in the United States in the early 1900s resulted in the establishment of a 152

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CURRENT STATUS AND LEGISLATIVE BASES TABLE 8-l Chemical, Bacteriological, and Temperature Standards for Grade A Milk and Milk Products Grade A raw milk for pasteurization (ultrapasteurization or aseptic processing): Temperature Cooled to 45F (7C) or less within two hours after milking: Provided that the blend temperature after the first and subsequent milkings does not exceed 50F (10C). 153 Bacterial limits - Individual producer milk not to exceed 100,000 per ml prior to comingling with other producer milk. Not to exceed 300,000 per ml as comingled milk prior to pasteurization. Antibiotics No zone equal to or greater than 16 mm with the Bacillus stearothermophilus disc assay method specified by NCIMS. Somatic cell count Individual producer milk: Not to exceed 1,500,000 per ml. Grade A pasteurized milk and milk products: Temperature Cooled to 45F (7C) or less and maintained thereat. Bacterial limits* 20,000 per ml. Coliform Not to exceed 10 per ml: Provided that, in the case of bulk milk transport tank shipments, shall not exceed 100 per ml. Less than 1 leg per ml by the Scharer Rapid Method or equivalent. No zone equal to or greater than 16 mm with the Bacillus stearothermophilus disc assay method specified by NCIMS. Grade A aseptically processed milk and milk products: Temperature None Bacterial limits No growth by test specified in Section 6. Antibiotics No zone equal to or greater than 16 mm with the Bacillus stearothermophilus disc assay method specified by NCIMS. Phosphatase Antibiotics *Not applicable to cultured products. SOURCES: USPHS/FDA, 1978; FDA, 1983e (1979 NCIMS, Aseptic Processing, and 1981 Antibiotic Testing NCIMS Changes). National Shellfish Sanitation Program (NSSP) (USPHS, 19251. The Public Health Service, the states, and the shellfish industry each accepted re- sponsibilities for certain aspects of the program. The National Shellfish Sanitation Program, Manual of Operations, was last revised in 1965 (US- DHEW, 19651. Current Levels of Concern and Application Microbiologial criteria are applicable at the international, federal, state (both health and agriculture departments), and local (city-county) levels,

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154 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA as well as by the food industry. The types of criteria at each of these levels are influenced by the mission and responsibilities of the agency or organization involved. INTERNATIONAL ACTIVITIES Joint FAD/WHO Food Standards Program Microbiological criteria for foods at the international level are applied primarily within the Joint FAD/WHO Food Standards Program as imple- mented by the Codex Alimentarius Commission (Olson, 19781. The his- tory of international food standards is relatively short. In 1958 the governing bodies of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) established a joint food standards program having the following purposes: protect the health of the consumers and ensure fair practices in the food trade; 2. promote coordination of all food standards work undertaken by in- ternational, governmental, and nongovernmental organizations; 3. determine priorities and initiate and guide the preparation of drafts of standards through and with the aid of appropriate organizations; 4. finalize standards elaborated under (3) above and, after acceptance by governments, publish them in a Codex Alimentarius as either regional or worldwide standards, together with international standards already fi- nalized by other bodies under (2) above, wherever this is practicable; 5. amend published standards, after appropriate survey in the light of developments. The Codex Alimentarius Commission was created to implement the program through which international food standards for processed, semi- processed, and raw foods are established. Membership in the commission is voluntary and is made up of member and associate member nations of FAO and WHO. At present, 121 nations are members (Kimbrell, 19821. Each member government is free to adopt each standard at any one of four levels of participation: 1. full acceptance of the standard and foods affected; 2. acceptance with specified deviations from the standard and fondest affected; The term standard(s) as used by Codex has a different meaning than that defined in this report. The Codex meaning relates to requirements or provisions set forth in various documents and codes quite apart from microbiological criteria.

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CURRENT STATUS AND LEGISLATIVE BASES 155 3. target acceptance of food products in anticipation of later approval of Codex Standard; 4. nonacceptance with free distribution of fondest conforming to Codex Standard. The specific objectives of the Codex program are: 1. to develop international food standards on a worldwide or regional basis; 2. to publish these standards in a food code (Codex Alimentarius); 3. to record acceptance and implementation of these standards by gov- ernments. To date, 148 international standards have been adopted and 19 more are under development (Kimbrell, 19821. These Codex standards are very similar to standards of identity; microbiological criteria have seldom been included as part of a standard. They contain qualitative statements about hygiene and end-product specifications. Codex standards are intended to be mandatory and thus require government approval. The United States has completed action on 41 of the 148 standards; 14 more are in the rule- making process. Other recommendations and provisions, including the codes of practice, are advisory in nature and do not require government approval. Subsidiary bodies (committees and expert groups) of the commission develop the standards and codes. Some committees deal with general subjects such as hygiene, analysis, or sampling applicable to all foods. Others, including the commodity committees, deal with specific foods. The Codex Committee on Food Hygiene has the major responsibility for all provisions of food hygiene related to standards or codes of practices including microbiological criteria. In recent years, activities to establish microbiological criteria for foods in international trade that may present microbiological hazards have increased. The First Joint PAD/WHO Expert Consultation on Microbiological Cri- teria for Foods (FAD/WHO, 1975) gave high priority to criteria for egg products, dried milks, precooked frozen seafoods, and frozen meat. A specific recommendation for establishment of microbiological specifica- tions for egg products was forwarded to the Codex Committee on Food Hygiene. Specifications were quickly adopted; they became the first mi- crobiological criteria for a food or food commodity group to be included in a Code of Hygienic Practice. A second Joint FAD/WHO Expert Consultation (FAD/WHO, 1977) recommended that the Committee on Food Hygiene consider development of microbiological criteria for precooked shrimps and prawns, foods for

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156 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRlTERlA Infants and children, and ice mixes and edible ices. The consultation recommended that high priority be given to consideration of criteria for dried milk, cheese, precooked frozen crabmeat, desiccated coconut, and precooked frozen lobster. It assigned a lesser, yet strong, priority to con- sideration of criteria for cooked meat and poultry, fish and fishery prod- ucts, dried soups and broths, dried fruits, enzymes, gelatin, protein concentrates, and low-acid salad dressing. This second expert consultation developed the statement on "General Principles for the Establishment and Application of Microbiological Criteria for Foods" for inclusion in the Codex Procedural Manual (see Appendix B). As of 1978 a Code of Practice on General Principles of Food Hygiene onH 19 (~1PC of Mv~ri~.ni~ Practice for specific food commodities had been completed or were in the process of being developed (Olson, 19781; by 1982, 21 codes of hygienic or technological practice had been devel- oped (Kimbrell, 19821. These codes apply to foods in the following com- modity groups: canned fruit and vegetable products, dried fruits, desiccated coconut, dehydrated fruits and vegetables including edible fungi, tree nuts, processed poultry, egg products, molluscan shellfish, low-acid and acid- ified low-acid canned foods, foods for infants and children, peanuts, frog legs, dried mail, natural mineral waters, and salvaging of canned foods. Microbiological criteria are included in the codes of hygienic practice for egg products, food for infants and children, dried milk, and natural mineral waters. Other international microbiological specifications are listed in Appendix C. ~ 1 1 ~ 1 ~ _ ~ ~ _ V ~ ^ ~ ~ d O ~ I_ European Economic Community The interests of the European Economic Community (EEC) in micro- biological criteria are based on the creation of a single common market for foods and feeds. The Common Market's attempts to eliminate technical barriers to trade include the consideration of the application of micro- biological criteria to foods and feeds in order to protect the health of the consumer. A proposal based on the Codex Alimentarius General Principles for the Establishment and Application of Microbiological Criteria for Foods was developed by the Commission of the European Communities and submitted to the European Council of Ministers in September 1981 (B. Simonsen, Danish Ministry of Agriculture, 1982. Personal communica- tion). A revised proposal was approved by the European Parliament in April 1982. The EEC is a circumscribed version of Codex; it has fewer members, covers a much smaller geographic area, and encompasses less diverse cultures. Both groups depend on voluntary membership, but as the rulings

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CURRENT STATUS AND LEGISLATIVE BASES 157 of the EEC are binding, the compliance may ultimately be more stringent with EEC criteria than with Codex criteria. International Commission on Microbiological Specifications for Foods (ICMSF) The ICMSF (Clark, 1978) is a voluntary advisory body which was formed to: 1. assemble and evaluate evidence about the microbiologial quality of foods; 2. consider whether criteria are necessary for any particular food; 3. propose suitable criteria where necessary; 4. suggest appropriate methods of examination. Functionally, the commission seeks to: 1. provide the bases for comparable standards for microbiological judg- ment of foods between countries; 2. foster safe movement of foods in international commerce; 3. overcome difficulties caused by differing microbiological standards and methods of analysis. The ICMSF activities focus on microbiological methods for examination of food, comparative studies on suitability of media, sampling plans and acceptance criteria, interpretation of microbiological data, and control of food operations to assure safety and quality. Cooperative work on methods has been carried out with the International Dairy Federation, the Inter- national Standards Organization, and the Association of Official Analytical Chemists. Classic work on sampling plans as related to foods has been published in the commission's book, Microorganisms in Foods 2, first published in 1974 and now in revision (ICMSF, 1974, 1985; see also Chapter 61. Canadian Microbiological Standards for Foods The Canadian regulations (Pivnick, 1978) apply to microbiological cri- teria at a national level where the production and processing conditions closely resemble those in the United States. The microbiological quality of food in Canada is governed by federal, provincial, and municipal jurisdictions. Provincial and municipal regulations may be more stringent than federal regulations. The Food and Drugs Act and Regulations cover all food sold in Canada regardless of place of production. The Canadian .

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158 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA Food and Drugs Act is similar to the U.S. Federal Food, Drug and Cos- metic Act. Sections 4, 5 and 7 are pertinent: (4) No person shall sell an article of food that (a) has in or upon it any poisonous or harmful substance; (b) is unfit for human consumption; (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; (d) is adulterated; or (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions. (5) No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, com- position, merit or safety. (7) No person shall manufacture, prepare, preserve, package or store for sale any food under unsanitary conditions. To avoid the possibility of misinterpretation, numerous standards that include microbial limits have been established under the act. However, differences do exist between the acts of the two nations. Whereas in the United States microbiological standards are usually estab- lished by a proposal, response, and hearing process, the Canadian law allows direct establishment of standards, with any product in violation of the standards being automatically illegal. The microbiological standards currently incorporated as regulations pursuant to the Canadian Food and Drugs Act are summarized in Appendix D. Sampling plans associated with each food or food commodity are included. U.S. FEDERAL AGENCIES Food and Drug Administration (FDA) The basic mission of FDA is to protect the health and welfare of the consumer. The principal responsibility relative to foods is to ensure that they are safe and wholesome and are honestly and informatively labeled. The legislative basis for the legal authority to act is the Federal Food, Drug and Cosmetic Act, as Amended January 1980 (U. S. Congress, 19801. Various sections of the act are applicable: Section 301, Prohibited Acts; Section 401, Standards; Section 402, Adulteration; Section 403, Mis- branding; and Section 801, Imports and Exports. Specific objectives of the act related to food include provisions to:

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CURRENT STATUS AND LEGISLATIVE BASES 159 1. prohibit adulteration of food Section 301 (b); 2. prevent food from containing any filthy, putrid, or decomposed substances Section 402 (a) (31; 3. prohibit preparation, packing, or storage under unsanitary conditions whereby it may become contaminated or be rendered injurious to health- Section 402 (a) (41; 4. prohibit misbranding of foods- Section 301 (b); 5. set reasonable definitions and standards of identity and reasonable standards of quality to promote honesty and fair dealing in the interests of consumers Section 401; 6. prohibit the importation of any adulterated or mishandled food- Section 801 (a). The operational program of FDA may specify microbiological criteria. In addition to the presence of foodborne pathogens and/or their toxins, these criteria may include indicator organisms that reflect contamination at harvest, poor manufacturing practices, and/or inadequate storage con- ditions. (For a discussion of criteria for foodborne pathogens, see Chapter 1, page 52, note 3.) Compliance Policy Guides Compliance Policy Guides (FDA, 1982a), where established, describe FDA's official policy on compliance matters and set forth specific criteria that must be met before the agency initiates legal actions. FDA has es- tablished microbiological criteria for certain foods susceptible to micro- biological contamination. These criteria may be used as the bases for legal actions. Compliance Policy Guides containing microbiological criteria applicable to foods and feeds are listed in Table 8-2. Contaminants covered by these guides include foodborne pathogens, bacterial toxins, mycotox- ins, and bacterial indicators such as aerobic plate counts (APC), Esche- richia colt, coliform, and coagulase-positive staphylococci. The testing of imported shrimp and frog legs for the presence of sal- monellae and the development of block lists involving compulsory testing for such commodities after finding repeated violations are carried out under the authority of Section 801 of the act. Food Defect Action Levels Criteria used in food ingredient and finished food product evaluations are identified in the Food Defect Action Levels first published in 1972 by the FDA (see FDA, 1982b). These levels for natural or unavoidable

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174 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA at the processing level. Its publication in the Federal Register, however, has been indefinitely postponed. National Marine Fisheries Service (NMFS) The U.S. Department of Commerce-National Marine Fisheries Service (USDC-NMFS) fishery products inspection program is a voluntary, fee- for-service program involving inspection and grading of fisheries products. A principal objective is to provide certification that fisheries products have passed federal inspection, which in this case consists mainly of physical examination of facilities and organoleptic evaluation of products. A recent update has been provided on the USDC-NMFS involvement with microbiological criteria (E. S. Garrett, USDC-NMFS. 1983. Personal communication). The NTMFS does not establish microbiological criteria for foods, but rather examines fishery products or causes them to be examined for conformance with the microbiological criteria of other or- ganizations including the Food and Drug Administration, the Department of Defense, private manufacturing firms, and/or institutional purchasers of seafoods. The USDC-NMFS inspection program recognizes and de- termines conformance to microbiological standards, specifications, and guidelines where such are either mandatory through codification in the Federal Regulations or included in a purchasing specification on product destined for either domestic or international trade. Microbiological food examination is used primarily to evaluate a product's safety status as opposed to its quality factors. Determinations of microbiological food safety are generally focused toward fully cooked, ready-to-eat items or the identification of process-induced hazards. History The NMFS had its origin in the Agricultural Marketing Act, as Amended (U.S. Congress, 1946), which provided for establishment of a system for distributing and marketing agricultural products based on the authority to inspect, certify, and identify agricultural products moving in interstate commerce. Fish and shellfish as well as processed products thereof were included as agricultural products. Some of the present commodity pro- grams in the USDA are based in this program; however, early efforts did not include fish and shellfish. The Fish and Wildlife Act (U.S. Congress, 1956) transferred all of the commercial fisheries activities from the USDA to the Bureau of Com- mercial Fisheries in the newly established Fish and Wildlife Service of the U.S. Department of the Interior. It was here in 1958 that the Fish and

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CURRENT STATUS AND LEGlSLATlVE BASES 175 Fisheries Products Inspection Program originated with a commitment to promote better health standards and sanitation. This program and some other commercial fishery activities were transferred in 1970 to the newly established National Marine Fisheries Service of the National Oceanic and Atmospheric Administration (NOAA) of the U.S. Department of Com- merce (USDC). The NMFS unit with the greatest involvement in the establishment and use of microbiological criteria is the Division of Seafood Research, Inspection and Consumer Services, which houses the USDC quality-inspection activities (Sackett, 19821. Current Cooperative Agreements In addition to the above basic legislative authorities, the USDC fisheries inspection service through NMFS is a participant in six Memorandums of Understanding with other federal agencies to ensure cooperation and co- ordination in seafood inspective activities (E. S. Garrett, ~JSDC-NMFS. 1983. Personal communication). The four Memorandums of Understand- ing concerned with microbiological criteria are listed in Table 8-6. The agency also participates in 11 formal federal/state agreements deal- ing with fishery product inspective activities. The agreements are with Alabama, Alaska, Arkansas, Florida, Hawaii, Louisiana, Maine, Missis- sippi, New Jersey, Oregon, and Tennessee. TABLE 8-6 U. S. Department of Commerce Memorandums of Understanding with Other Federal Agencies Concerned with Microbiological Criteria Participating Agencies Date Purpose FDA/USDC January 17, 1975 FDA/USDA/USDC April 2, 1975 DOD/USDC May 14, 1980 USDC/FDA May 22, 1981 To define respective roles in food . . . . . Inspection activities. To transfer USDA's fish-meal salmonella control program to NMFS. To transfer from DOD to USDC . . . . . logistics agency origin ln- spection responsibility for DOD procurement. To improve research coordina- tion and cooperation and min- imize duplication of research effort. SOURCE: E. S. Garrett, National Marine Fisheries Service, 1983.

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176 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA Activities Under Memorandums of Understanding. The FDA has es- tablished several microbiological standards that are enforced in the USDC inspection program. These microbiological standards are the "commer- cially sterile" requirement contained in the Code of Federal Regulations for Low-Acid Canned Food GMP (FDA, 1983c) and the microbiological criteria for whole fish protein concentrate (FDA, 1983d). Additionally, FDA may enforce a requirement for imported fishery products such as shrimp from Asia to be free of Salmonella; NMFS then examines the product for this pathogen. FDA also has Compliance Policy Guidelines for crabmeat and cooked langostinos (FDA, 1982a). The Department of Defense (DOD) purchases fresh and frozen oysters under a Federal Purchasing Document (DOD, 1976) that contains micro- biological specifications. The USDC inspection program routinely em- ploys the microbiological specifications when inspecting oysters for military procurement. Activities With Industry. The USDC seafood inspection program also determines conformance with a limited number of corporate quality as- surance or quality control microbiological standards, specifications, or guidelines. Each firm has its own set of specifications and contracts with NMFS to do the inspection and analyses. Firms using microbiological criteria specified in these programs are either large, sophisticated fishery product processors or institutional purchasers. Research The USDC inspection program routinely uses microbiological evalua- tions to determine safe and suitable processing operations for use in pro- ducing fully cooked, ready-to-eat product. In addition, applied research is conducted to assess potential process-induced hazards, such as con- trolled atmosphere packaging of fishery products. Raw materials entering USDC-inspected plants are surveyed when there is concern, for instance, that polluted glaze water may have been used on a frozen product. When deemed appropriate, a product safety analysis is carried out by actions such as toxin assays of product suspected of contamination with Clostri- dium botulinum. U.S. Army Natick Research and Development Center One of the objectives of this center is to provide safe and nutritionally adequate food products in support of existing and future service concepts. The problems of food procurement for military purposes are somewhat

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CURRENT STATUS AND LEGISLATIVE BASES 177 different from those for civilian purposes. While garrison (base) feeding may resemble civilian food service in terms of the degree of misuse and abuse to which foods may be subjected, field rations may be subject to additional abuse. The rations may be stored for extended periods of time and considerable delays may be encountered between preparation and consumption. The legislative base for activities relative to microbiological criteria is the Defense Cataloging and Standardization Act, P.L. 10 USC, 2451-56 (U.S. Congress, 1976), implemented by Department of Defense (DOD) directive 4120.3, "Defense Standardization and Specification Program (DSSP)" (DOD, 19781. The DSSP includes approximately 400 Military and Federal Food Specifications. Of these, about 35 contain microbio- logical criteria, most of which apply to finished foods. Microbiological criteria used for monitoring foods for the military as described in military and federal specifications were listed by Powers (19761. A summary of the current status of these microbiological criteria for foods purchased for the military (including pertinent Military and Federal Specification Numbers and Sampling Plans) prepared specifically for this subcommittee report (G. Silverman, U.S. Army Natick Research and Development Center. 1984. Personal communication.) is presented in Appendix E. An increasing number of items are now purchased under a Commercial Item Description (CID) to save on inspection and analytical costs. A CID document is applied only to commercially available products for which there is already a civilian market. The company's sales to the government must be less than 50% of its total sales and the company must certify that the product meets certain requirements. Microbiological criteria are in- cluded in CIDs only if problems had been encountered with similar prod- ucts already being procured. Agencies other than DOD may carry out some of the inspection activities associated with military food purchases. The USDA inspects food plants except where USDA specifications are in disagreement with those of DOD. The NMFS is responsible for assuring that the microbiological criteria are being met in the case of shucked oysters. The military has no specifications on other fresh products. The input of the Natick Microbiology Branch into specifications is made during the ration developmental stages and modified, if necessary, after initial procurement from commercial processors. The microbiology branch is presently concentrating on updating their criteria to make them uniform for given classes of foods and to benefit from current analytical techniques and concepts. For this reason the microbiological requirements listed in Table 1 of Appendix E are illustrative of those proposed for this class of

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178 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA rations. The criteria are derived from data obtained from analyzing actual production samples. Those listed in other Appendix E tables are current criteria. Critical processing parameters for achieving commercially ster- ilized or microbiologically stabilized foods are also established but are not listed in the tables in Appendix E. These parameters include minimal Fo values as well as water activity (prefried, canned bacon; cakes) and pH (rice). Federal and Regional Level Cooperation State Level Grade a Milk Products. The cooperation between FDA and the states relative to grading of milk products is discussed in the section above on cooperative programs and in Chapter 9, Part A. The chemical, bacterio- logical, and temperature standards of this program are listed in Table 8-1 . Changes have been introduced since the adoption of the Pasteurized Milk Ordinance (PMO), 1978 Recommendations (Table 8-11. Some ma- terial has been added on standards for ultrapasteurized and aseptically processed milk and milk products. Testing for antibiotic residuals in milk and milk products using a Bacillus stearothermophilus disc assay method has also been approved. Manufactured Milk Products. Grade B raw milk or raw milk for manufacturing purposes may be regulated by USDA recommended re- quirements (USDA, 1972) if they are adopted by the states or by require- ments established by the individual states. The products may be subject to the microbiological criteria established in the Standards for Grades of Dairy Products (USDA, 1975) or to criteria established by the individual state. For further comments, see Tables 8-3 and 8-4 and Chapter 9, Part A. Shellfish and Seafood Sanitation Programs. The federal and state mi- crobiological criteria for shellfish and other seafoods are listed in the National Fisheries Institute Handbook (Martin and Pitts, 19821. Standards and/or guidelines, advisory and mandatory, as in use in 48 states are included. The states with criteria for shellfish use NSSP regulations for harvest, processing, and distribution of shellfish and also use NSSP pro- cedures for growing area surveys and plant inspections. (See discussion above of the National Shellfish Sanitation Program and the Interstate Shellfish Sanitation Program.) Additional monitoring and laboratory test- ing may also be applied by state authorities.

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CURRENT STATUS AND LEGISLATIVE BASES 179 Other Foods. A number of guidelines have been promulgated by the states (Wehr, 19821. Twenty-nine agencies had microbiological guidelines or standards in effect as of November 1981. The number of criteria for a single agency varied from 1 to as many as 40. There is little agreement on foods singled out and the criteria proposed. The major portion of the criteria are applicable to shellfish, meat and meat products, and delicatessen items. However, criteria are applied nar- rowly to single items such as pecans or gelatin by some agencies and broadly to "products and levels unspecified" or "non-packaged foods, general" by other agencies. Sampling plans are random or unstated. The bases for the criteria developed by each agency may be existing criteria from another agency, internally generated data, externally generated data, some combination of the three, experience, or opinion. Criteria for a single food, hamburger or ground meat for example, may be implemented at the retail level by one agency, at the distribution and retail levels by another, at the processing and retail levels by a third, and at all three levels by a fourth. City-county (Local) Level The objective of local agencies in regard to food surveillance generally is to respond to and solve local problems relating to public health and nuisance abatement. The agencies have a broad interface with small op- erators involved in food processing or preparation of often very sensitive foods as well as with some aspects of food service. The local agency may monitor the safety and quality of locally produced and/or consumed food products, principally delicatessen and other spe- cialty food-processing operations and food service establishments. The agency may follow up on local reports of alleged foodborne disease in- cidents, poor quality products showing evidence of spoilage, insanitary and unsightly facilities, and similar complaints. The scope and depth of food surveillance, the qualifications of the field and laboratory personnel involved, and the adequacy of laboratory facilities and procedures are influenced by the population and area served by the local unit. Some city- county units where food safety and quality are perceived to be a problem may be very well structured and equipped to engage in food surveillance. In addition, the personnel in these units may be adequately trained and experienced to make appropriate interpretations of data. The nature of local food-processing surveillance may be quite formal and well organized. Frequently, however, local units have neither criteria of record nor ex- perience in evaluating the results of microbiological analyses carried out during routine inspection or in the course of an investigation of alleged

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180 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA foodborne disease. These conditions could lead to inappropriate setting of criteria or regulatory actions by the local authority and could result in unnecessary financial burden to industry with no reduction of risk to the public. The legislative bases for activities of local agencies are local ordinances. The data bases may be meager or nonexistent. The basic information often comes from other agencies or laboratories, and the criteria may have been intended for other uses with other foods. At times there may be little critical evaluation of the pertinence or validity of the application, e.g., applying criteria developed for highly processed foods to unprocessed or fermented foods. INDUSTRY Microbiological guidelines and specifications are used by industry in the sale and purchase of raw materials and ingredients for further pro- cessing. They are used by industry to: 1. assure safety and wholesomeness of raw material and ingredients and determine their suitability for further processing; 2. establish evidence of adequate processing and assess sanitation; 3. identify and monitor critical control points; 4. determine conformance tq finished product microbial limits; 5. assure safety and wholesomeness of finished products; 6. assure compliance with regulatory requirements. The use of microbiological criteria by food processors varies greatly. Sophisticated companies establish microbiological specifications over a wide variety of critical raw materials and in many cases not only monitor incoming raw materials, but also inspect the facilities in which these products are produced. Such companies, in addition, have established Hazard Analysis Critical Control Point programs (see Chapter 10) to mon- itor critical control points and where appropriate to utilize microbiological criteria in such monitoring. In addition, finished product testing through microbiological analysis and guidelines is common in the food industry. At the other end of the spectrum there are processors who make no use of microbiological criteria. Hazards presented by their products are iden- tified as a result of regulatory inspections, consumer complaints, rejection by other processors using their products, or as a result of an outbreak of foodborne disease. Unfortunately, purchase specifications are frequently written by a pur- chasing agent whose knowledge of the relevance of such specifications

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CURRENT STATUS AND LEGISLATIVE BASES 181 to the microbiological acceptability of the finished product concerned is insufficient for selection of appropriate specifications. REFERENCES Clark, D. S. 1978 The International Commission on Microbiological Specifications for Foods. Food Technol. 32(1):51 -54, 67. DOD (Department of Defense) 1976 Oysters, fresh (chilled) and frozen: Shucked. Federal Specification PP-0-956G. Dec. 27 (Amendment). DOD (Department of Defense; Office of Undersecretary of Defense for Research and Engineering) 1978 Defense standardization and specifications program: Policies, procedures and instruc- tions. Manual DOD 4120. 3M. Philadelphia: U.S. Naval Publ. and Forms Center. Duran, A. P., B. A. Wentz, J. M. Lanier, F. D. McClure, A. H. Schwab, A. Swartzentruber, R. J. Barnard, and R. B. Read, Jr. 1983 Microbiological quality of breaded shrimp during processing. J. Food Prot. 46:974- 977. FAD/WHO (Food and Agriculture Organization/World Health Organization) 1975 Consultation, 1975. Microbiological specifications for foods. Report of Joint FAO/ WHO Consultation. Geneva. 1977 Consultation, 1977. Microbiological specifications for foods. Report of Second Joint FAD/WHO Consultation. Geneva. February 21-March 2. FDA (Food and Drug Administration) 1972 Certain foods for which there are no standards of identity. Proposed microbiological quality standards. Federal Register 37(186):20038-20040. 1973 Part 11 Standards of quality for foods for which there are no standards of identity. Federal Register 38(148):20726-20730. 1975 Memorandum of Understanding Between AMS/USDA and FDA. No. FDA 225-75 4002. 1976a Standards of quality for foods for which there are no standards of identity. Federal Register 41(154):33249-33253. 1976b Food Service Sanitation Manual. DHEW Publ. No. (FDA) 78-2081. Washington, D.C.: U.S. Department of Health, Education and Welfare. Standards of quality for foods for which there are no standards of identity. Federal Register 42(50):14326. 1978a Quality standards for foods with no identity standards. Federal Register 43(45):9272. 1978b The vending of foods and beverages. DHEW Publ. No. (FDA) 78-2091. Washington, D.C.: U.S. Department of Health, Education and Welfare. 1980 Frozen fish sticks, frozen fish cakes, and frozen crab cakes; Recommended micro biological quality standards. Federal Register 45(108):37524-37526. 1982a Compliance Policy Guides Manual. #PB-271176. Springfield, Va.: National Tech nical Information Service. 1982b The Food Defect Action Levels. Publ. No. (FDA) 82-2161. 1982c Retail Food Store Sanitation Code. 1982. Recommendation of the Association of Food and Drug Officials of the U.S. Department of Health and Human Services. Washington, D.C.: Public Health Services (Food and Drug Administration). 1983a Raw breaded shrimp, microbiological defect action levels. Federal Register 48 (175): 40563-40564.

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182 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA 1983b Interstate Certified Shellfish Shippers List. March 1, 1983. 1983c Thermally processed low-acid foods packaged in hermetically sealed containers. Gen- eral provisions. Current good manufacturing practice. Code of Federal Regulations 21 CFR 113.5. 1983d Food additives permitted for direct addition to foods for human consumption. Special dietary and nutritional additives. Whole fish protein concentrate. Code of Federal Regulations. 21 CFR 172.385. 1983e 1983 NCIMS Actions. Transmittal 83-9. IMS-a-21, 10-3-83 of National Conference of Interstate Milk Shippers to DHHS/FDA/MSD. ICMSF (International Commission on Microbiological Specifications for Foods) 1974 Microorganisms in Foods. 2. Sampling for microbiological analysis: Principles and specific applications. Toronto: University of Toronto Press. 1985 Microorganisms in Foods. 2. Sampling for microbiological analysis: Principles and specific applications, 2nd Ed. In preparation. Johnston, R. W. 1981 Microbiological monitoring and surveillance programs. Paper presented at Science Division Directors Seminar, March. Washington, D.C.: U.S. Department of Agri culture. 1982 Microbiology programs of Food Safety and Inspection Service. Paper presented at 7th Annual Eastern Research Highlights Conference, National Food Processors As- sociation, November 8. Washington, D.C.: U.S. Department of Agriculture. Kimbrell, E. F. 1982 Codex Alimentarius food standards and their relevance to U.S. standards. Food Tech- nol. 36(6):93-95. Majorack, F. C. 1982 FDA's industry quality assurance assistance program. Food Technol. 36(6):87-88, 95. Martin, R. E., and G. T. Pitts 1982 Handbook of State and Federal Microbiological Standards and Guidelines. Washing- ton, D.C.: National Fisheries Institute. Olson, J. C., Jr. 1978 Microbiologicalspecificationsforfoods:Internationalactivities.FoodTechnol.32(1):55- 57, 62. Pivnick, H. 1978 Canadian microbiological standards for foods. Food Technol. 32(1):58-60, 62. Powers, E. M. 1976 Microbiological criteria for food in military and federal specifications. J. Milk Food Technol. 39(1):55-58. Sackett, I. D., Jr. 1982 Quality inspection activities of the National Marine Fisheries Service. Food Technol. 36(6):91-92. U.S. Congress 1944 Public Law 410. Public Health Service Act, 58th Stat., 683. Washington, D.C.: Superintendent of Documents. 1946 Agricultural Marketing Act, as Amended. Washington, D.C.: Superintendent of Doc uments. 1956 Fish and Wildlife Act. Washington, D.C.: Superintendent of Documents. 1968a Wholesome Meat Act. Washington, D.C.: Superintendent of Documents. 1968b Wholesome Poultry Products Act. Washington, D.C.: Superintendent of Documents. 1970 Egg Products Inspection Act. Washington, D.C.: Superintendent of Documents.

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CURRENT STATUS AND LEGISLATIVE BASES 183 1976 Defense Cataloging and Standardization Act. PL 10 USC 2451 -56. Washington, D.C.: Superintendent of Documents. 1980 Federal Food, Drug and Cosmetic Act, as Amended. Washington, D.C.: Superin- tendent of Documents. USDA (U.S. Department of Agriculture) 1972 Milk for manufacturing purposes and its production and processing. (Agricultural Marketing Service). Federal Register 37(68):7046-7066. 1975 General specifications for approved dairy plants and standards for grades of dairy products. (Agricultural Marketing Service). Federal Register 40(198):47910-47940. 1980 Salmonella Surveillance Program, DA Instruction No. 918-72. January 28, 1980. USDA, FSQS/PDQD. Washington, D.C.: U.S. Department of Agriculture. 1982a United States standards for grades of nonfat dry milk (Spray process). Code of Federal Regulations 7 CFR, Subpart L. 58.2528. 1982b United States standards for grades of nonfat dry milk (Roller process). Code of Federal Regulations 7 CFR, Subpart M. 58.2553. 1982c United States standards for instant nonfat dry milk. Code of Federal Regulations 7 CFR, Subpart U. 58.2753, 58.2754. 1982d United States standards for grades of dry whole milk. Code of Federal Regulations 7 CFR, Subpart S. 58.2704, 58.2705, 58.2706. 1982e United States standards for grades of dry buttermilk. Code of Federal Regulations 7 CFR, Subpart Q. 58.2655. 1982f United States standards for dry whey. Code of Federal Regulations 7 CFR, Subpart O. 58.2605. 1982g United States standards for grades of edible dry casein. Code of Federal Regulations 7 CFR, Subpart V. 58.2803, 58.2804. USDHEW (U.S. Department of Health, Education and Welfare) 1965 National Shellfish Sanitation Program. (Revised 1965) Part I Sanitation of Shellfish Growing Areas. Part II Sanitation of the Harvesting and Processing of Shellfish. Washington, D.C.: U.S. Government Printing Office. USPHS (U.S. Public Health Service) 1924 Standard Milk Ordinance. Reprint 971, Public Health Reports, November 7. 1925 Report of Committee on Sanitary Control of the Shellfish Industry in the United States. Supplement 53 to Public Health Reports. November 6. 1927 Standard Milk Ordinance and Code. Mimeographed tentative draft. November. USPHS/FDA (U.S. Public Health Service/Food and Drug Administration) 1978 Grade A Pasteurized Milk Ordinance. 1978 Recommendations. PHS/FDA Publ. No. 229. Washington, D.C.: U.S. Government Printing Office. Wehr, H. M. 1982 Attitudes and policies of governmental agencies on microbial criteria for foods an update. Food Technol. 36(9):45-54, 92.