See correction: Federal Register, March 3, 1994
[Federal Register: January 28, 1994] _______________________________________________________________________ Part II Department of Health and Human Services _______________________________________________________________________ Food and Drug Administration _______________________________________________________________________ 21 CFR Parts 123 and 1240 Proposal To Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 123 and 1240 [Docket Nos. 90N-0199 and 93N-0195] Proposal To Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt regulations to ensure the safe processing and importing of fish and fishery products (hereinafter referred to as seafood). These procedures include the monitoring of selected processes in accordance with Hazard Analysis Critical Control Point (HACCP) principles. HACCP is a preventive system of hazard control that can be used by food processors and importers. FDA is proposing these regulations because a system of preventive controls is the most effective and efficient way to ensure that these products are safe. DATES: Written comments by March 29, 1994. The agency is proposing that any final rule that may be issued based upon this proposal become effective 1 year following its publication. ADDRESSES: Written comments, data, or information to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Philip Spiller, Center for Food Safety and Applied Nutrition (HFS-401), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-254-3885. For further information concerning the guidance entitled ``Fish and Fishery Products Hazards and Controls Guide,'' contact: Donald W. Kraemer (address above). For further information concerning the economic impact analysis contained in this proposal, contact: Richard A. Williams, Jr., Center for Food Safety and Applied Nutrition (HFS-726), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5271. SUPPLEMENTARY INFORMATION: I. Overview The purpose of these proposed regulations is to establish mandatory preventive controls to ensure the safety of seafood products sold commercially in the United States and exported abroad. These preventive controls will be based on a system known as HACCP. HACCP is a system by which food processors and importers can evaluate the kinds of hazards that could affect their products, institute controls necessary to keep these hazards from occurring, monitor the performance of these controls, and maintain records of this monitoring as a matter of routine practice. FDA is proposing to require that domestic and foreign processors and importers adopt HACCP controls to prevent the occurrence of hazards that could affect the safety of these seafood products for consumers. If these regulations are adopted, FDA will review the adequacy of HACCP controls as part of its program of mandatory inspections and import examinations. Such a review will occur in addition to traditional inspection activities. FDA is also encouraging, but not proposing to require, that processors and importers adopt the same types of controls for nonsafety hazards relating to economic adulteration and quality. FDA is proposing to make HACCP mandatory for the seafood industry for the following reasons: 1. Adoption of HACCP controls by the seafood industry, coupled with inspections by FDA based on the HACCP system, will produce a more effective and more efficient system for ensuring the safety of seafood products than currently exists. The current inspection system places too great a burden on Government inspectors to uncover problems and to take regulatory action to address those problems. HACCP places primary responsibility upon the industry to demonstrate that hazards are understood and are being prevented. 2. A nationally mandated HACCP system will provide a basis for enhanced consumer confidence in the safety of seafood products. Consumers should not be afraid to eat foods, such as seafood, that are recommended as useful lower fat and lower saturated fat substitutes for higher fat meats (Ref. 1, p. 13; Ref. 2, p. 21). 3. The know-how for applying HACCP to seafood is in an advanced state of development. A considerable amount of work on applying HACCP to seafood has already been done by some States, academia, and the Federal Government as well as through cooperative activities between the Federal Government and industry and through independent industry efforts. 4. Seafood industry representatives have urged the Federal Government to institute a mandatory, HACCP-type inspection system for their products. 5. A nationally mandated HACCP-type system of controls appears to be a prerequisite for continued access to world markets. II. Safety A. Background Ensuring the safety of seafood presents special challenges to both the industry that produces it and to Government agencies charged with protecting the public health. Seafood is unique in many respects. While often thought of as homogeneous in nature, seafood is actually a variety of products encompassing literally hundreds of species that have little in common other than an aquatic origin. Collectively, seafoods have perhaps the most diverse and complex microbiology of any food commodity (Ref. 3, p. xi). The range of habitats for edible species is also extraordinary and diverse ranging from cold to warm water, bottom dwelling to surface feeding, deep sea to near shore, and fresh water to saltwater. Fish are exposed to the bacteria and viruses that naturally occur in their environment as well as to those that enter the water through pollution. Chemicals, some of which are toxic to humans, can accumulate in fish as well. Fish can also accumulate natural toxins and parasites that are specific to marine animals. As a consequence, fish are subject to a wide range of hazards before harvest. B. The Safety Data The question of how safe is the seafood in the marketplace has been the subject of public debate in recent years. This debate has occurred partly because precise data on the numbers and causes of foodborne illnesses in the United States do not exist. Foodborne illnesses tend to be significantly underreported to public health authorities. Data on foodborne illnesses that are meaningful from an epidemiological standpoint are difficult and expensive to develop. The Centers for Disease Control and Prevention (CDCP) of the U.S. Public Health Service (PHS) compiles data in its Foodborne Disease Surveillance System that are reported from State and local health authorities. All foodborne illnesses are underreported to this system (Ref. 4). Nonetheless, CDCP data are the best available and can at least be used to identify trends and emerging concerns about various diseases (Ref. 5, p. 219). The data suggest that most seafood-related illnesses result from certain natural toxins in finfish and from viruses in molluscan shellfish consumed raw or partially cooked (Ref. 4). The wide range of other hazards that can affect seafood undoubtedly result in illnesses, but the available data indicate that such illnesses are not as common. Thus, according to the CDCP data, the actual occurrence of problems tends to be limited relative to the range of hazards that could cause problems and tends to be associated with a minority of commercially available species. In the CDCP system, seafood accounted for 4.8 percent of reported cases of foodborne illness for the period 1973 to 1987 (Ref. 4). However, as CDCP has pointed out, variations in rates of underreporting among different foods and varying etiologies make it impossible to compare safety among different foods based solely on CDCP data (Ref. 4). This is certainly true for seafood. Some seafood-related illnesses tend to be overreported to CDCP's system relative to other foodborne diseases, due largely to their distinctive characteristics, while others are probably underreported relative to other causes because they are less distinctive and more difficult to diagnose (Ref. 4). FDA has attempted to determine the relative safety of seafood through risk assessment. The results of this effort indicate that the risk of illness associated with molluscan shellfish consumed raw or partially cooked is greater than for any cooked flesh food. However, seafood overall is as safe or safer than other flesh foods in terms of frequency of illness (Refs. 5, p. 25; and 6). The conclusions of the National Academy of Sciences' (NAS) Institute of Medicine, in its 1991 report entitled ``Seafood Safety,'' are consistent with the CDCP data and the FDA risk assessment. According to NAS, ``Most seafoods available to the U.S. public are wholesome and unlikely to cause illness in the consumer'' (Ref. 7, p. 1). Moreover, in reviewing the CDCP data, the report noted that the 23 percent increase in seafood consumption in the United States in the 10- year period ending 1989 was not accompanied by a concomitant increase in reported seafood-borne illnesses (Ref. 7, p. 27). Nevertheless, as NAS pointed out, ``there are areas of risk'' (Ref. 7, p. 1). The report addressed at some length virtually every possible risk that could affect seafood and made numerous recommendations relating to existing and proposed control measures. NAS recommended that improvements be made in the present system of regulatory control (Ref. 7, p. 1) and repeatedly recommended HACCP controls wherever appropriate. ``Inspection and testing should focus on actual problems (as in HACCP systems),'' NAS concluded (Ref. 7, p. 16). C. The Principal Hazards The most notable seafood-related hazards involve the following: 1. Bacteria Because bacteria either naturally live in, or can survive in, aquatic habitats, there are a large number of pathogenic bacteria that can be found in seafood, particularly molluscan shellfish. Many of these bacteria are far more harmful to specific human subpopulations, such as the elderly, immunocompromised, or persons with specific underlying diseases, than to the population as a whole. The size of these subpopulations is increasing, however. Therefore, concerns about bacterial contamination of seafood, particularly molluscan shellfish, are increasing. In the United States, 4.4 percent of botulism outbreaks have been attributed to seafood. The predominant type of botulism organism in aquatic environments is the kind most readily destroyed by heat. Thus, many types of processing, if done properly, can negate the risk of botulism from seafood. Nonetheless, with the trend toward greater use of modified atmosphere and vacuum packaging (i.e., packaging that excludes oxygen) to enhance the shelf life and the desirability of refrigerated foods, traditional controls need to be enhanced because Clostridium botulinum can grow in the absence of oxygen. Other bacteria of concern include Listeria monocytogenes, a hazardous foodborne microorganism that is ubiquitous in nature and is commonly found in food processing environments; Salmonella, which is not a marine organism but can contaminate seafood through improper handling and sanitation practices; and Staphylococcus aureus, another pathogen associated with sanitation and handling (Ref. 8, pp. 14 and 15). 2. Viruses Several viruses that are infectious to humans enter aquatic habitats through sewage. These viruses can concentrate in shellfish and be present and infective even when bacterial indicators of fecal pollution are absent. Viruses probably cause the bulk of seafood- associated disease, particularly the Norwalk and Norwalk-like agents, which are linked to the consumption of contaminated raw or undercooked molluscan shellfish (Ref. 7, p. 30). 3. Natural Toxins Problems associated with naturally occurring toxins in fish have been recognized for centuries. Ciguatera poisoning is perhaps the most significant problem associated with a natural toxin. The toxin is produced by microscopic organisms and can be transmitted to humans through the consumption of finfish that have eaten these organisms through the food chain (Ref. 7, p. 89). The larger, more predacious fish (groupers, snappers, barracuda, amberjack) and reef fish belonging to the crevally or ulua (Carangidae) family are generally more likely to contain ciguatoxin than other types of fish (Ref. 7, p. 89). Because the toxin is heat stable, cooking does not make the fish safe to eat (Ref. 9, p. 1). On average, 70 cases of ciguatera poisoning are reported annually in the United States and its possessions and territories (Ref. 7, p. 89). Deaths are rare, and the acute symptoms of the disease are usually of short duration; however, neurological symptoms can persist for extended periods. Ciguatera is geographically localized, with the majority of illnesses reported from tropical or subtropical areas. Other toxins of public health concern include domoic acid, which was detected in seafood from the U.S. Pacific coast for the first time in the fall and winter of 1991-1992 (Ref. 10, p. 1,113); and saxitoxin, or paralytic shellfish poison, which has periodically made molluscan bivalves toxic and has recently affected Pacific Northwest crab harvests (Ref. 11). 4. Parasites Parasites, such as anasakid nematodes (round worms), naturally infect certain fish and ocean mammals (Ref. 12, p. 724). Human parasitic infections almost always occur from the consumption of raw (sushi, sashimi) or undercooked fish. Historically, probably no more than five cases are reported on average in the United States each year and the likelihood of occurrence is estimated to be very low (Ref. 5, p. 25). Problems with parasites are avoidable through commercial freezing of the raw fish before consumption. 5. Chemical Contaminants The presence of toxic chemicals in the aquatic environment creates the potential for contamination of seafood products. These chemicals include pesticides; other industrial chemicals, such as polychlorinated biphenyls; heavy metals, such as lead, cadmium, and mercury; and petroleum hydrocarbons. Marine species, especially deep sea varieties, comprise the majority of seafood consumed in this country. This seafood has little potential to contain most chemical contaminants at levels of toxicological concern (Ref. 13, p. 6). However, there are some contaminants that can be present at significant levels, methylmercury in certain species being perhaps the most notable. Fresh water species, especially nonmigratory bottom feeders, are generally the most exposed to a variety of chemical contaminants (Ref. 13, p. 6). 6. Decomposition Finfish are generally regarded as being much more perishable than terrestrial flesh foods (Ref. 14, p. 3). Decomposition is a problem with seafood products frequently encountered by FDA and is the subject of the majority of regulatory actions taken by the agency against violative seafood products (Ref. 15). It is largely an economic and aesthetic problem; however, in some species it can lead to illness because of the formation of scombrotoxin (histamine) during decomposition. Scombroid poisoning is completely preventable by proper handling, i.e., by proper time and temperature controls. D. Additional Factors Affecting Safety Unlike beef and poultry, seafood is still predominately a wild- caught flesh food that frequently must be harvested under difficult conditions and at varying distances from processing, transport, and retail facilities. There are nearly 100,000 vessels in the U.S. fishing fleet alone (Ref. 7, p. 22). These conditions, distances, and duration of fishing trips, can tax any system of controls designed to ensure safety and prevent spoilage. In addition, several hundred vessels are seagoing processing factories, many of which operate in remote waters. For regulators, these ships that process at sea can be difficult and expensive to reach while they are operating, and individual inspectors face hazards such as ship-to-ship transfers on the high seas. There may be as many as 350 commercially marketed species (Refs. 16; and 19, p. 35). Consumer preferences for one species over another and significant price differences between species can lead to economic fraud through the substitution of cheaper species for more expensive ones. Unlike beef and poultry, seafood is subject to significant recreational harvest. Beyond the 15 pounds of seafood consumed per capita from commercial channels, an additional 4 pounds may be consumed from recreational sources. Some recreational catch finds its way into commercial channels as well. Thus, recreational fishing can have a bearing on the safety of commercial seafood. Commercial fishermen avoid or are prohibited from harvesting from polluted areas, but recreational fishermen, especially recreational harvesters of molluscan shellfish, might not be as aware of, or might ignore, local advisories or water closures. Processors need to be aware of and control the source of their raw materials, and importers must ensure that their shipments are obtained from acceptable sources. An additional complicating factor in ensuring the safety of seafood is the fact that no other flesh food is imported in the quantity, or from as many countries, as seafood. Imports include finished products as well as products to be further processed domestically. Over 55 percent of seafood consumed in this country is imported. It comes from approximately 135 countries. Several of these countries have advance regulatory structures for seafood safety, but many others are developing nations that lack structures for seafood regulation comparable to those in more developed nations (Ref. 35, pp. 113 and 114). Therefore, it is of utmost importance, that those who handle and process seafood commercially, including importers, understand the hazards associated with this type of food, know which hazards are associated with the types of products with which they are involved, and keep these hazards from occurring through a routine system of preventive controls. The seafood industry, indeed, the food industry as a whole, must be primarily responsible for the safety and quality of the food that it produces. The regulator's primary role should be to verify that the industry is meeting this responsibility and to take remedial action when it is not. The alternative of relying solely on Government inspectors to identify problems and provide solutions would involve enormous costs to the public and would be extremely inefficient, assuming it could be done at all. For the most part, seafood processors and importers are not required, through licensure or examination, to understand seafood hazards as a prerequisite to being able to do business. (There are exceptions. A few States, such as Alaska, do require processors to conform to HACCP as a condition of doing business (Ref. 17).) While many processors and importers have such an understanding, this knowledge is not universal. It is not unusual for FDA to receive inquiries about safety requirements and related matters from those who wish to process or import seafood, or who already do, that indicate a lack of awareness of hazards specific to their products. Most of the industry does not have HACCP-trained personnel, and many firms lack dedicated quality assurance personnel (Ref. 18, p. 35). Seafood processing in the United States is done by several thousand businesses, many of which are small, old, and family operated (Ref. 19, p. 35). This situation is in contrast to the beef and poultry industries, in which market share is concentrated among a small number of large processors. Seafood firms tend to be small, fragmented operations sized in reference to anticipated benefits, because of the significant, uncontrollable risks involved in this business (Ref. 5, p. 225). Also, because many harvests are seasonal, many of their operations are intermittent (Ref. 20). The seasonal nature of the industry can affect worker skills and practices relating to safety, while older facilities and equipment can be more difficult to maintain in terms of adequate sanitation and proper processing and storage temperatures (Ref. 20). III. The Need for Regulations A. The Current Inspection System Is Not Well-Suited to Seafood Seafood processors are subject to periodic, unannounced, mandatory inspection by FDA. Seafood processors and importers are also able to purchase inspection services from the National Marine Fisheries Service (NMFS) of the U.S. Department of Commerce. These inspection services have been primarily trade-related, such as grading. Until recently, FDA's overall regulatory program for seafood received slightly over $20 million per year. Because much of the program involves activities such as research, laboratory analyses, and technical assistance and training to States, a substantial portion of it has tended to be invisible to the general public. Public interest and debate tends to focus on the more visible aspects of regulation, primarily inspection. The congressional debate of the past several years over the adequacy of the Federal regulatory program for seafood has been framed, more often than not, in terms of the need for mandatory inspection. Traditionally, FDA inspected the equivalent of a quarter of its total domestic inventory of seafood establishments per year. Since 1990, however, FDA has received significant funding increases for seafood. The current budget of slightly over $40 million has permitted the agency to increase the frequency of its inspections. It now inspects so-called high risk processors at least once per year and all others at least biennially. (Because States also inspect processors, the collective frequency is actually higher.) Even so, because of seafood's unique characteristics (e.g., the fact that it is predominantly wild caught and presents a wide range of possible hazards), it is questionable whether the current regulatory system, which was developed for the general food supply, is best suited for the seafood industry. The current system provides the agency with a ``snapshot'' of conditions at a facility at the moment of the inspection. However, assumptions must be made about conditions before and after that inspection on the basis of the ``snapshot,'' as well as about important factors beyond the facility that have a bearing on the safety of the finished product. The reliability of these assumptions over the intervals between inspections creates questions about the adequacy of the system, particularly, as the congressional hearings on the subject over the past several years have shown, for seafood. FDA's inspections are based upon the regulations on current good manufacturing practice in manufacturing, packing, or holding human food at part 110 (21 CFR part 110). For the most part, these guidelines consist of broad statements of general applicability to all food processing on sanitation, facilities, equipment and utensils, processes, and controls. HACCP-type controls are listed as one of several options available to prevent food contamination (Sec. 110.80(b)(13)(i)) but they are otherwise not integral to the guidelines. Current Federal inspection and surveillance strategies verify the industry's knowledge of hazards and preventive control measures largely by inference, i.e., whether a company's products are in fact adulterated, or whether conditions in a plant are consistent with current good manufacturing practice (CGMP). Consequently, the current system places the burden on the Government to prove that a problem exists rather than on the firm to establish for itself, for the regulator, and for consumers, that adequate controls exist to ensure safety. The current approach is inefficient and, unless Government inspections are conducted with some frequency, can lead to conditions that can elevate risk and erode public confidence. It also has the potential to cause some inequities. While the same standards of adulteration apply to all products in interstate commerce, processors and importers who use a system of preventive controls coupled with adequate monitoring must compete against those who do not. A survey conducted by FDA in 1992-1993 of manufacturers of ready- to-eat seafood products revealed conditions that strongly suggest the need for a system that emphasizes preventive controls to ensure that products are safe by design. Ready-to-eat products require special care in processing because they do not require, and are unlikely to receive, any further cooking by consumers that would destroy pathogenic microorganisms. The survey focused on whether preventive controls exist rather than on the results of expensive end-product sampling. The agency found that, in significant measure, firms have not been employing the types of preventive processing steps necessary to ensure a safe and wholesome product. Some of the preliminary results are as follows (Ref. 21). 1. Fifty-four percent of the firms that pasteurized products had not established the adequacy of their pasteurization process to destroy pathogenic microorganisms such as the spores of C. botulinum, type E, which can cause significant illness and death in humans. The pasteurization process is not simple and must be done with precision in order to consistently deliver a thermal process that will inactivate the spores of C. botulinum, type E and prevent recontamination of the product after it has been heat treated. The CGMP at part 110 state that pasteurization must be adequate. Realistically, the only way for FDA to determine, or at least infer, the adequacy of the process now is to analyze samples of finished product for the presence of pathogens. 2. Twenty-seven percent of the firms that pasteurized products did not have temperature-indicating devices on their pasteurizers, and 35 percent did not have temperature-recording devices. Temperature monitoring is essential to ensure that a thermal process is properly controlled. Part 110 addresses temperature indicating and recording devices only for refrigeration, while pasteurization involves cooking. A temperature-recording device is important for purposes of preventive control because it provides a continuous history of the cooking step. 3. Forty-two percent of firms that pasteurized products did not perform can seam evaluations or performed them less frequently than every 12 hours. Such evaluations are necessary to ensure that there will not be microbiological contamination of the finished pasteurized product. FDA's regulations for the processing of low acid canned food (parts 108 and 113 (21 CFR parts 108 and 113)) require such evaluations every 4 hours as an HACCP-type control, but products that need refrigeration (e.g., pasteurized products) are outside the scope of those regulations. Again, part 110 states only that the pasteurization process should be adequate. FDA must conduct end-product sampling and analysis to determine, or at least infer, whether a pasteurization process is adequate. 4. Forty-three percent of firms that pasteurized products did not perform cooling water sanitizer strength checks to ensure that the pasteurized product would not be contaminated during this process. The presence of a sanitizer in the cooling water is important to prevent contamination of the product after pasteurization because during cooling, some water can be drawn into hot cans. Part 110 does not specifically mention a cooling water sanitizer. The ``adequate'' provision cited above is the closest relevant provision, and FDA must conduct end-product sampling and analysis to determine, or at least infer, whether a pasteurization process is adequate. 5. Eighty-four percent of the firms did not monitor the internal temperature of products during the various stages of processing. Such monitoring is important because time/temperature abuse can result in the growth of pathogenic microorganisms, decomposition, and, in some cases, the formation of histamine. Part 110 states that all reasonable precautions should be taken to prevent contamination and recommends temperature control as one type of precaution. Again, end-product sampling is the only practical way for FDA to measure compliance. 6. Fourteen percent of the firms did not have temperature- indicating devices on their finished product coolers, and 89 percent did not have temperature-recording devices. Part 110 states that processors should have one or the other but does not specifically require that processors monitor either one. While 14 percent were out of compliance, most who were in compliance opted for the control that did not provide a continuous record. 7. Thirty-one percent of the temperature-indicating devices on finished product coolers were more than 5 deg.F out of adjustment. Fifty-five percent of these were giving readings that were too low. For these, the deviation would permit the growth of pathogenic microorganisms, decomposition, and histamine formation. Part 110 specifically states that thermometers should be accurate. Five degree deviations are clearly out of compliance. A significant percentage of firms surveyed were not paying attention to a significant preventive control. 8. Twenty-three percent of temperature-indicating devices on pasteurizers and 80 percent of such devices on finished product coolers were never calibrated. Again, part 110 calls for accuracy. The failure to calibrate means that these firms have no assurance that their devices are accurate. A preventive control is not being applied, and thus a significant percentage of processors are apparently relying on Government investigators to determine accuracy during inspections. Also, this deficiency may account in part for the deviations described in section III.A.7. of this document. 9. Twenty-nine percent of temperature-recording devices on finished product coolers were never checked for accuracy, while 34 percent of such devices on pasteurizers and 74 percent on finished product coolers were checked less frequently than once a month. Temperature-recording devices are easily jarred out of calibration and must be routinely adjusted to agree with an accurate temperature-indicating device. Thus, they need to be checked for accuracy at least at the start and the end of each processing day in order to determine whether they remained accurate throughout the day's production. 10. Forty-eight percent of the firms cleaned and sanitized the processing equipment less frequently than every 4 hours, while 13 percent cleaned and sanitized less than every 12 hours. Part 110 states that sanitation practices should occur as frequently as necessary. In order to control salmonella and other undesirable bacteria within a facility, the frequency should be at least every 4 hours, and more frequently if feasible. This frequency helps reduce the likelihood that these microorganisms will enter a rapid phase of growth during which their numbers increase logarithmically (Ref. 22, p. 114; Ref. 23, p. 2). 11. Twenty-two percent of the firms did not perform plant or equipment sanitation audits (i.e., inspections), and 35 percent did not check the strength of hand or equipment sanitizing solutions. These results reveal that a significant number of plants are not checking up on themselves to ensure that they were doing an adequate job of sanitation. In such plants, the only check on sanitation is provided by the Government investigators who visit the plant. Other survey and inspection findings by FDA and others strongly indicate that the seafood industry does not always operate on the basis of preventive controls. For example, recent FDA and State surveys showed that many processors of smoked and smoke-flavored fish are operating outside of the parameters that have been demonstrated through scientific research to be necessary to ensure that the hazard from botulism is adequately controlled. These parameters are process times and temperatures and salinity levels. A number of firms surveyed did not even know their own operating parameters, let alone the scientifically established ones (Refs. 24, 25, and 26). For seafood products such as these that require no cooking by the consumer, preventive measures by the processor to eliminate C. botulinum, type E to the maximum extent possible are critically important. B. Alternatives Other Than HACCP Continuous visual inspection of seafood is not a viable alternative. Few hazards associated with seafood are detectable through visual inspection. Moreover, the costs of such a system would likely exceed the nearly half-billion-dollar public outlay now required to operate this kind of system for meat and poultry. Another alternative would be to direct significant additional resources toward greatly increasing the frequency of FDA's inspection of seafood, as well as increasing the agency's sampling, laboratory analysis, and related regulatory activities with respect to seafood. While thousands of samples of domestic and imported seafood products are collected each year for analysis in FDA laboratories, and these samples are scientifically designed to represent a broad range of products, they are generally perceived by the public to represent only a small fraction of the total poundage of seafood consumed in this country. Substantial new expenditures would be needed to increase laboratory analyses to nationally statistically significant levels. Even if the funds for increased inspection and increased sampling and analysis were available (which they are not), this approach alone would likely not be the best way for the agency to spend its money to protect the public health. Reliance on end-product testing involves a certain amount of inefficiency that can require very large sample sizes to overcome. NAS recently observed that ``the statistical uncertainties associated with lot sampling make this an unreliable method for ensuring safety of food products * * *'' (Ref. 7, p. 283). FDA has traditionally sought to minimize this type of inefficiency by targeting its efforts based on its experiences, but some inefficiency is unavoidable. NAS recommended the HACCP system as an alternative (Ref. 7, p. 283). C. Current Import System Is Not Well-Suited to Seafood Similar considerations apply to imports. FDA does not generally inspect processing facilities in other countries to determine whether seafood products are being prepared, packed, or held there under appropriate conditions. Such inspections are extremely costly and require an invitation from the foreign country. Traditionally, therefore, FDA's primary strategy for seafood imports has involved: (1) Reviewing all customs entries documents to determine which imported products to examine or sample; (2) conducting wharf examinations of selected products based on that review; and (3) sampling and laboratory analyses as appropriate. One concern about this process that has been voiced with some regularity in the media, Congress, and elsewhere is that FDA physically looks at less than 5 percent of all imports. This figure is somewhat misleading because it refers to seafood lots that can vary substantially in size. Also, it does not take into account such factors as the representative nature of the examinations, FDA's automatic detention program for imports that requires importers of products with a history of problems to obtain a laboratory analysis and certification prior to entry, or the fact that imports receiving further processing in the United States become subject to domestic inspection. Nonetheless, it is certainly true that most imported seafood is not physically sampled or examined by a Federal health official. The total number of customs entries for seafood each year is approaching 200,000 (Ref. 27) from about 135 countries (compared to about 33 countries for beef and poultry (Ref. 28)), and huge sums of money would be needed to enable FDA to increase its physical examination and sampling program to nationally, statistically significant levels. Still, many developing countries export seafood products to this country, and their regulatory protections tend to be comparatively weak, if they exist at all. Processing conditions in such countries do not always meet U.S. standards for sanitation. While many importers are conscientious about the safety and quality of the products that they import, others have little understanding of potential hazards. The denial of entry of a violative lot may be regarded as simply a cost of doing business, which is offset in many cases by insurance purchased against just such an eventuality. Such policies are identified as ```FDA rejection' insurance'' and usually the premium is 2 to 3 percent of the value of the shipment (Ref. 29). It is reasonable to assume that this cost is being passed on to the consumer. The insurance also permits importers to buy seafood from foreign processors without first ensuring that it meets FDA requirements, i.e., that it is safe, wholesome, and properly labeled. This system leaves much to be desired. It, too, is a ``snapshot''- type approach that places a significant burden on the Government to uncover problems without fostering or promoting industry responsibility. It lacks the preventive controls that the agency has tentatively concluded are the minimum necessary to ensure safety. Moreover, it has not provided full public confidence in the safety of imported seafood. D. Public Confidence Continuing public concerns about the safety of seafood provide additional evidence that the current regulatory system is not well- suited for seafood. Consumers have become increasingly concerned about the effects of pollution on seafood. Medical wastes washing up on beaches, ocean dumping of toxic wastes, chemical run-off, and multiple oil spills continually dramatize the fact that bodies of water, no matter how large, can be adversely affected by human activity. Media and other public attention on seafood safety and quality, and on the adequacy of the current regulatory program for seafood, has been substantial in recent years, and there is no reason to expect that this attention will decrease. Problems with some seafood products draw attention to, and has tended to raise concerns about, all seafood, a situation that is bad for consumers because seafood is a low fat product, and bad for an industry that can ill afford it. Several hearings on the sufficiency and direction of the Federal seafood safety program have been held in both houses of Congress since in 1989. In addition, numerous bills have been introduced in Congress for the stated purpose of establishing a Federal program of mandatory inspection of seafood. Different bills passed the House and the Senate in 1990 but were not reconciled before the end of the 101st Congress. This legislative activity has tended to reinforce the view that the public is placed at some risk because no Federal mandatory program for seafood exists. While this view is inaccurate in a number of respects, it is fueled in part by the notable differences in the frequency with which regulatory agencies inspect the processors of different types of flesh foods. As stated above, beef and poultry slaughterhouses are subject to continuous visual inspection under programs operated by the U.S. Department of Agriculture (USDA). Public concerns about seafood regulation persist despite the recent increases in Federal resources and inspections for seafood. A major U.S. newspaper recently published an article entitled ``A Sea of Uncertainties,'' which expressed anxiety about the coverage of seafood inspection. ``The odds are,'' it observed, ``that the bit of fish you cook tonight got to your table without ever being poked or prodded or even glanced at by a government inspector'' (Ref. 30). No realistic system, however, could possibly look at every piece of fish. Moreover, in the current budget climate, improvements in the system for ensuring the safety of seafood will likely have to be qualitative rather than quantitative. Estimated combined Federal, State, and local outlays for regulatory activities relating to seafood are about $100 million annually (Ref. 31), but pressures to cut back funding exist at all of these levels. IV. The HACCP Option Thus, the Government must find new approaches to food safety that enable it to become more efficient and minimize costs wherever possible. A new paradigm is needed for seafood inspection, one that provides an ongoing, scientifically established system of intensive, preventive monitoring but that does not require undue resources. When faced with similar pressures, Canadian health authorities responsible for seafood safety came to the following conclusion: One of the key challenges will be to endure the scrutiny of the informed consumer and demanding marketplace * * *. The Canadian Government, as well as other western governments will be under constant pressure to limit spending as the aging population places more and more demands on services and as the Federal deficit is addressed. This means inspection programs cannot expect to have ever increasing resources to meet the challenges of the 1990's. Smarter and more cost effective ways must be developed to carry out their mandate. (Ref. 32, p. 502.) The ``smarter and more cost effective way'' chosen by the Canadians is HACCP. A. What is HACCP? HACCP is a preventive system of hazard control. Its application to food production was pioneered by the Pillsbury Company (Pillsbury) during that company's efforts in the early 1960's to create food for the U.S. space program. Pillsbury concluded that then existing quality control techniques could not provide adequate assurance that the food being produced was not contaminated. The end-product testing necessary to provide such assurance would be so extensive that little food would be left for space flights. According to Howard E. Bauman: We concluded after extensive evaluation that the only way we could succeed would be to develop a preventive system. This would require us to have control over the raw materials, process, environment, personnel, storage, and distribution as early in the system as we possibly could. We felt certain that if we could establish this type of control, along with appropriate record keeping, we should be able to produce * * * a product we could say was safe. For all practical purposes, if this system was implemented correctly, there would be no testing of the finished packaged product other than for monitoring purposes. (Ref. 33, p. 2.) In the succeeding years, the system devised by Pillsbury has been recognized worldwide as an effective system of controls. The system has undergone considerable analysis, refinement, and testing. FDA believes that HACCP concepts have matured to the point where they can be formally implemented for seafood on an industry wide basis. HACCP consists first of an identification of the likely hazards that could be presented by a specific product, followed by the identification of the critical control points in a specific production process where a failure would likely result in a hazard being created or allowed to persist. These critical control points are then systematically monitored, and records are kept of that monitoring. Corrective actions are also documented. The National Advisory Committee on Microbiological Criteria for Foods (NACMCF), which was established by USDA in conjunction with FDA at the recommendation of NAS, has developed seven widely accepted HACCP principles that explain this process in greater detail (Ref. 34). These HACCP principles follow. 1. Hazard Analysis The first step in the establishment of an HACCP system for a food process is the identification of the hazards associated with the product. NACMCF defined a hazard as a biological, chemical, or physical property that may cause a food to be unsafe for consumption (Ref. 34, p. 186). The hazard analysis step should include an assessment of both the likelihood that these hazards will occur and their severity if they do occur. It should also involve the establishment of preventive measures to control them. To be addressed by the HACCP system, the hazards must be such, according to NACMCF, that their prevention, elimination, or reduction to acceptable levels is essential to the production of a safe food. Even factors beyond the immediate control of the processor, such as how the food will be distributed and how it will be consumed, must be considered because these factors could influence how it should be processed. Hazards that involve low risk and that are not likely to occur need not be considered for purposes of HACCP. NACMCF has developed numerous issues to be considered during hazard analysis. These issues relate to matters such as ingredients, processing, distribution, and the ultimate intended use of the product. FDA urges seafood processors and importers to become familiar with these issues. They include, for example, whether a food contains any sensitive ingredients that may present microbiological hazards, chemical hazards, or physical hazards; whether sanitation practices can affect the safety of the food that is being processed; and whether the finished food will be heated by the consumer. For seafood, this analysis is particularly important because it is consumed raw or partially cooked to an extent unrivaled for other flesh foods. Examples of seafoods that are consumed in this way include raw molluscan shellfish, sushi, steamed clams, and cold smoked salmon. 2. Identify the Critical Control Points in the Process Points in a manufacturing process that may be critical control points, as listed by the NACMCF, include cooking, chilling, specific sanitation procedures, product formulation control, prevention of cross contamination, and certain aspects of employee and environmental hygiene. For example, a cooking step that must be operated at a specific temperature and for a specified time in order to destroy microbiological pathogens is a critical control point. Likewise, refrigeration required to prevent hazardous microorganisms from multiplying or toxins from forming is a critical control point. 3. Establish Critical Limits for Preventive Measures Associated With Each Identified Critical Control Point In essence, this step involves establishing a criterion that must be met for each preventive measure associated with a critical control point. Critical limits can be thought of as boundaries of safety for each critical control point and may be set for preventive measures such as temperature, time, physical dimensions, moisture level, water activity, Ph, available chlorine, or sensory information such as texture, aroma, or visual appearance. Critical limits may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental studies, and experts. 4. Establish Procedures To Monitor Critical Control Points Monitoring is a planned sequence of observations or measurements to assess whether a critical control point is under control and to produce an accurate record for future use in verification. NACMCF identifies three main purposes for monitoring: (1) It tracks the system's operation so that a trend toward a loss of control can be recognized, and corrective action can be taken to bring the process back into control before a deviation occurs; (2) it indicates when loss of control and a deviation has actually occurred, and corrective action must be taken; and (3) it provides written documentation for use in verification of the HACCP plan. As NACMCF points out, continuous monitoring is possible with many types of physical and chemical methods. For example, temperature and time for a scheduled thermal process can be recorded continuously on temperature-recording charts. When it is not possible to monitor a critical limit on a continuous basis, monitoring intervals must be reliable enough to permit the manufacturer to determine whether the hazard is under control. 5. Establish the Corrective Action To Be Taken When Monitoring Shows That a Critical Limit Has Been Exceeded While the HACCP system is intended to prevent deviations in a planned process from occurring, perfection is rarely, if ever, achievable. Thus, NACMCF states that there must be a corrective action plan in place to: (1) Determine the disposition of any food that was produced when a deviation was occurring; (2) fix or correct the cause of noncompliance to ensure that the critical control point is under control; and (3) maintain records of corrective actions. 6. Establish Effective Recordkeeping Systems That Document the HACCP System This principle requires the preparation and maintenance of a written HACCP plan that sets out the hazards, critical control points, and critical limits identified by the firm, as well as the monitoring, recordkeeping, and other procedures that the firm intends to take to implement the plan. Secondly, this principle requires the maintenance of records generated during the operation of the plan. Ultimately, it is the recordkeeping associated with HACCP procedures that makes the system work, both from the standpoint of the HACCP operator (industry) and the regulator. One conclusion in a study of HACCP performed by the Department of Commerce is that correcting problems without recordkeeping almost guarantees that problems will reoccur (Ref. 35, p. 85). The requirement to record events at critical control points on a regular basis ensures that preventive monitoring is occurring in a systematic way. 7. Establish Procedures to Verify That the HACCP System Is Working This process involves: (1) Verifying that the critical limits are adequate to control the hazards; (2) ensuring that the HACCP plan is working properly, e.g., that it is being followed, and that appropriate decisions are being made about corrective actions; and (3) ensuring that there is documented, periodic revalidation of the plan to make sure that it is still relevant to raw materials as well as to conditions and processes in the plant. Government regulatory activities also help ensure that the HACCP system is working. B. Specific Applications to Seafood As NAS has pointed out, most health risks associated with seafood originate in the environment (Ref. 7, p. 1). Many of these risks are the subject of research by FDA, the National Oceanic and Atmospheric Administration (NOAA) of the Department of Commerce, the Environmental Protection Agency (EPA), and others. This research is designed both to produce information that will provide a better understanding of the toxins, bacteria, chemical contaminants, and other phenomena and to provide a basis for developing more advanced types of controls for them. Within the limits of existing scientific knowledge, however, the industry can and should use HACCP to control the source and condition of raw materials based on an understanding of the likely hazards that need to be prevented. The Pillsbury team that first applied HACCP to food production began with a systematic review of raw materials to ensure that they were not bringing hazards into the plant. As Bauman pointed out: This required the development of a familiarity with the raw materials that was not a normal process in food product development * * *. The areas of concern ranged from the potential presence of pathogens, heavy metals, toxins, physical hazards and chemicals, to the type of treatments the ingredients might have received such as pesticide applications or a pasteurization step. (Ref. 33, pp. 2 and 3.) While all these areas that were of concern to Pillsbury are not germane to all seafoods, they certainly cover the range of hazards to which seafoods are susceptible. Of the three most frequently reported seafood-related illnesses, two are environmentally related: ciguatera in warm water reef fish, as described previously, and water-borne viruses in molluscan shellfish consumed raw and partially cooked. While a rapid test to detect ciguatoxin in fish continues to be the target of research at FDA and elsewhere, processors and importers can exercise control by ensuring that they are obtaining fish from responsible sources that are not harvesting from waters where ciguatoxin is being found. Ciguatera has been associated with recreational fishing. Processors and importers should address through HACCP any safety considerations that might exist with the commercial sale of recreational catch generally, depending upon species and locale. For viruses from molluscan shellfish to be controlled, HACCP measures must be in place to ensure that molluscan shellfish harvested from polluted waters are not entering commerce. Other key safety controls relate to proper refrigeration to keep potentially harmful microbes from reaching dangerous levels. The third seafood-related illness, scombroid poisoning, is caused by a toxin created as part of the process of decomposition after a fish has died. The formation of scombrotoxin can be triggered by time/ temperature abuse anywhere in the commercial system and beyond, including as early as on the harvesting vessel if good handling controls are not followed. FDA is considering whether to develop good handling practice requirements (not necessarily HACCP) specific to fishing vessels and invites comment on this matter. FDA has traditionally refrained from directly regulating fishing vessels, largely because of the huge number of such vessels in the U.S. fleet, even though it has authority to do so. FDA invites comment on whether those boats that harvest scombrotoxin-forming species, or any other specific component of the fleet, should be subject to mandatory HACCP controls. Meanwhile, processors and importers of scombrotoxin-forming species can exercise HACCP controls aimed at ensuring that their incoming raw materials or imported shipments have not been time/temperature abused. Because any HACCP plans for such processors or importers would be clearly inadequate if scombrotoxin were not identified as a hazard and appropriate controls were not in place and systematically monitored, processors and importers should consider placing time/temperature requirements on vessel owners as a prerequisite to doing business. HACCP can also be applied to control of hazards from chemical contaminants, even though the full range of possible chemical hazards is still imperfectly understood. Government and academia have important roles to play in researching the toxicities of these chemicals, in monitoring them, and in performing various forms of risk assessment. In some cases, these efforts may result in the establishment of national maximum limits. In other cases, regional advisories may be more appropriate. The seafood industry has a responsibility to know whether chemical hazards are associated with the species they are handling, whether the occurrence of such hazards depends on harvest site or other factors, and whether a sampling and analysis program on their part would be appropriate. Processors and importers should monitor the origin of raw materials and imported shipments to ensure, for example, that harvest did not occur in locations subject to public health advisories. These are but a few examples of environmentally related hazards to which HACCP can be applied. HACCP controls can also ensure that hazards are not being created inside a processing facility through improper handling, cooking, or storing. C. Regulatory Considerations From a regulatory standpoint, inspections of processing facilities and of importers' plans and records would become more efficient and would be likely to have a much greater impact if HACCP controls were in place. A key feature of an inspection system tied to implementation of HACCP is access by Government investigators to the HACCP plan and to monitoring records kept under that plan. In contrast to the ``snapshot'' provided by current inspections, examination of HACCP records will enable an investigator to see how the processing facility or the importer operates over time. It will enable an investigator to determine whether problems have occurred, and how they were addressed. It will also enable an investigator to spot trends that could lead to problems, and thus to help prevent them from occurring. Additionally, it will enable the regulator to review the adequacy of the processor's or importer's preventive control system itself. Under such an inspection system, inadequate preventive controls would warrant remedial or regulatory action regardless of whether the processor's or importer's product is actually contaminated or unsafe. HACCP is not a zero risk system, however. Problems in food production and processing will still occur. HACCP systems are designed to detect and document those problems, so that they can be corrected as quickly as possible. Thus, regulatory action would not be warranted on the basis of the mere occurrence of processing problems. It would be warranted, though, if the HACCP system is not functioning properly to detect and correct the problems, or if adulterated food is allowed to enter into commerce. An inspection program tied to mandatory industry adoption of the HACCP system would not be industry self-certification, nor would it be deregulatory. An investigator under such a program would perform HACCP reviews but not to the exclusion of other inspection activities. Thus, it is highly doubtful whether any falsification of records would go undetected. Investigators are taught to recognize falsification of records, and the inspection techniques they use would likely reveal any instances in which the records do not reflect actual conditions and practices. Falsification of records carries strict penalties under Federal law. Unlike the other inspection options discussed previously that would involve continuous or high-frequency inspection and commensurate costs, an inspection system tied to HACCP would not necessarily require an increase over current inspection frequencies. Recordkeeping and record inspection will provide the inspector, however, with a broader view. Moreover, to the extent that States adopt equivalent inspection programs in response to these proposed regulations, the resultant network of consistent inspections would, in effect, increase the frequency of inspections at no additional cost. The value to the nation of such a network would be substantial. FDA recognizes that many States are under considerable pressure to cut back funding in areas where a Federal presence also exists. For seafood, however, FDA urges that the States maintain their programs, strengthen them to the extent possible, and work with the agency to integrate them into a HACCP-based, Federal/State network. Such an approach would be consistent with recommendations relating to the role of States made by NAS in its 1991 report on seafood safety (Ref. 7, p. 16). FDA especially invites comment on how the proposed FDA program should mesh with an existing State HACCP program for seafood, such as the program that exists in Alaska, so that inconsistent Federal and State HACCP requirements are not imposed. V. The Proposal A. Decision To Propose To Make Use of HACCP Mandatory For the foregoing reasons, FDA has tentatively concluded that a new system of regulatory controls for seafood is necessary, and that HACCP is the appropriate system. Therefore, FDA is proposing to add part 123 to establish procedures for the safe processing and importing of fish and fishery products. FDA is proposing these procedures under sections 402(a)(1), 402(a)(4), and 701(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(1), 342(a)(4), and 371(a)), in conjunction with section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264). Section 402(a)(1) of the act states that food is adulterated if it bears or contains any poisonous or deleterious substance that may render it injurious to health. Section 402(a)(4) of the act was included in the act to provide additional control over insanitary and contaminated foods. (H.R. Rept. No. 2139, 75th Cong., 3d sess. 6 (1938).) Section 701(a) of the act authorizes the agency to adopt regulations for the efficient enforcement of the act. Section 361 of the PHS Act authorizes the agency to adopt regulations to prevent the spread of communicable diseases. The proposed regulations set out those requirements that the agency tentatively has concluded are the minimum necessary to ensure that, to the extent possible, the processing and importation of fish and fishery products will not result in a product that is injurious to health. These requirements include the establishment of HACCP preventive controls that take into account the unique characteristics of seafood products. If a processor or an importer fails to adopt and implement an HACCP plan that complies with the requirements that FDA is proposing, or otherwise fails to operate in accordance with these proposed provisions, it will be preparing, packing, or holding the food under insanitary conditions under which the food may be rendered injurious to health. Thus the food will be adulterated under section 402(a)(4) of the act and subject to regulatory action by FDA. The agency has reflected this fact in proposed Sec. 123.6(d). FDA's tentative decision to adopt regulations that require the implementation of HACCP principles by the seafood industry is grounded in the statutory objective of preventing food safety and sanitation problems. Section 402(a)(4) of the act does not require that FDA demonstrate that food is actually hazardous or contaminated in order to deem the food adulterated and to exclude it from commerce. Instead, under section 402(a)(4) of the act, food producers must assure that the food is not ``prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.'' [emphasis added.] In enforcing section 402(a)(4) of the act, FDA has considered, among other things, prevailing industry standards and the technical state-of-the-art in determining on a case-by-case basis whether the conditions under which a company is processing or handling food satisfy section 402(a)(4) of the act. This proposed regulation would codify an appropriate state-of-the-art means of assuring seafood safety and of preventing sanitation problems under FDA's authority to promulgate regulations for the ``efficient enforcement'' of the act (section 701(a) of the act (21 U.S.C. 371(a))). The factual record that FDA has developed concerning the safety and sanitation issues posed by seafood illustrates the need for codifying appropriate preventive methods consistent with the emerging technical state-of-the-art and explains why FDA's initial focus in implementing HACCP is on seafood. Proof that any particular process or set of manufacturing conditions in the production of seafood has in fact caused injuries or sanitation problems is not, however, a legal prerequisite to this rule. The proposed adoption of this rule is supported by several additional factors. First, as stated above, the application of HACCP to the seafood industry has been the subject of a substantial amount of work, by the Federal government, some States, academia, and the seafood industry itself, to develop specific HACCP models and otherwise to apply HACCP to seafood processing and importation. The Model Seafood Surveillance Project (MSSP) was conducted by NOAA at the request of Congress in 1986 to design an inspection system for seafood consistent with HACCP principles. This project resulted in the development of 16 regulatory models for specific seafood products that describe the basis for a mandatory seafood inspection system. Each model applies many of the NACMCF principles described above in the context of a specific product, such as breaded shrimp, raw fish, and molluscan shellfish (Ref. 35, pp. 67 to 73). The MSSP was conducted with significant industry involvement. The importance of industry participation in the development of HACCP systems was stressed by NAS in its 1985 study of HACCP (Ref. 36, pp. 13, 309, and 310). As part of the MSSP project, 49 workshops were conducted involving 1,200 industry, State, and university participants. HACCP controls were considered for economic fraud and plant sanitation/ hygiene as well as for safety because economic fraud and sanitation have been problems in the seafood industry. The MSSP models cover nearly all the types of seafood products consumed in the United States except for low acid canned seafood, which is already subject to a mandatory HACCP control and inspection system under the low acid canned food regulations adopted by FDA. Low acid canned seafood products represent about 25 percent of all seafoods consumed in the United States (Ref. 7, p. 23). The regulatory system in place for them represents the first formal application of HACCP principles to food by a regulatory agency. As with this proposal, the regulations for low acid canned foods were requested by industry, and they were developed through cooperation between Government and industry. Although the low acid canned food regulations apply HACCP concepts to two hazards only, i.e., botulism in canned foods and contamination because of poor container integrity, they are regarded as a major success and demonstrate the benefits that HACCP can provide. Botulism in canned goods has been effectively controlled under the low acid canned food regulations and is no longer a particular source of consumer concern. NAS recently concluded that canned fish is among the safest of seafood items. (Ref. 7, p. 320). Seafood industry associations have been active in developing HACCP systems that their members could use. For the past several years, the New England Fisheries Development Association (NEFDA) has been assisting firms in the northeast to implement HACCP systems through Federal grants. NEFDA's activities include a pilot project for 15 processing firms and participation in a retail seafood HACCP pilot (Ref. 18, p. 26). Academia has been active as well. For example, the Oregon Sea Grant, which services the Oregon marine community as part of the national Sea Grant extension service, has issued a publication, ``Hazard Analysis & Critical Control Point Applications to the Seafood Industry'' (Ref. 37). This publication explains the fundamentals of HACCP, inventories microbial hazards of seafoods, and describes model HACCP systems for specific types of seafood processing operations. As a result of efforts like these by Government, industry, and academia, a considerable amount of literature and expertise now exist to facilitate the development of HACCP systems by seafood processors and importers, significantly more than for most other major segments of the food industry. Given the advanced state of knowledge about the application of HACCP to the seafood industry, FDA is proposing to make the use of HACCP mandatory for the seafood industry to ensure that there is compliance with section 402(a)(1) and 402(a)(4) of the act. Second, seafood industry representatives have been urging the Federal Government to adopt a mandatory, HACCP-based system for years. The National Fisheries Institute, the largest seafood industry trade association, and others from the seafood industry testified repeatedly at congressional hearings from 1989 through 1992 in support of legislation that would mandate such a system. Indeed, nearly all of the seafood bills introduced in the Congress since the late 1980's, including the bills that passed both chambers in 1990, contained HACCP elements. While there were different views on the merits of these legislative proposals, virtually all Government agencies, both Federal and State, that testified on these proposals--as well as most other witnesses--expressed support for the HACCP concept as it applies to seafood. The Chairman of the Interstate Shellfish Sanitation Conference (ISSC), an organization of States, Federal agencies, and industry that considers issues relating to molluscan shellfish safety, testified that a HACCP-type approach is now being used for aspects of the shellfish program and endorsed HACCP for all seafood. Significant elements of the seafood industry continue to press for the Federal Government to institute a HACCP-based program. An article in a 1992 edition of a seafood trade publication on the advantages of HACCP concluded: ``With the seafood industry under a continuing barrage of negative press regarding the wholesomeness and safety of product, the industry is impatient to get started with a seafood inspection program that will reassure consumers * * *'' (Ref. 19, p. 39). In February, 1993, the Executive Vice President of the National Fisheries Institute wrote to the Secretary of Health and Human Services asking that she ``initiate a state-of-the-art program for seafood which would be of significant benefit to consumers * * *. HACCP-based regulation is very feasible for the seafood industry * * *. There is no reason to wait for congressional action to put this modern technology in place'' (Ref. 38). As recently as April, 1993, the President of the Pacific Seafood Processors wrote to FDA expressing support for a mandatory seafood HACCP program (Ref. 39). The members of that organization process the majority of domestically harvested seafood. These requests provide further evidence of the appropriateness of this proposal. B. Preparing for HACCP FDA recognizes that this proposal involves a significant departure from current practices for most processors and importers and intends to work cooperatively with the industry in the establishment of this proposed system. The agency's experiences under both its HACCP-based low acid canned food regulations and the HACCP-based pilot programs for seafood that it conducted with NOAA in 1991 demonstrate the need for cooperation and technical support between the agency and the industry in order to establish HACCP and to make it work. The FDA/NOAA joint pilot programs involved the development and implementation of HACCP-based systems by seafood processors and HACCP- based inspections by the two agencies. Even though the FDA/NOAA pilots involved highly motivated seafood firms that volunteered to adopt HACCP, the firms found it difficult initially to identify hazards and critical control points associated with their own products and processes (Ref. 40). As both the agencies and the firms discovered, HACCP involved new ways of thinking and behaving that were not readily understood or implemented. A considerable amount of consultation and assistance between the firms and the Government proved to be extremely helpful. This experience reinforces the view that regulations that impose a HACCP-based system are needed for the seafood industry and thus represents a third factor supporting the appropriateness of this proposal. The systematic kind of preventive thinking that HACCP requires is not universal, but it can be adopted. Regulations will ensure that processors and importers do so. Significantly, once participants in the pilot programs made the transition to HACCP, they were able to identify benefits from using HACCP to themselves and to consumers in terms of product safety and quality, as well as plant sanitation and organization (Ref. 40). VI. International Trade Although not a public health issue, international trade is also a major consideration in determining the advisability and benefits of a new system of seafood regulation and therefore will be addressed here. It is estimated that close to 40 percent of the fish and shellfish harvested from the world's oceans, lakes, and other bodies of water entered international trade in 1991 (Ref. 41). This movement reflects the need to match supplies with demand. Nations often have species in their waters for which there is little or no demand among their consumers, while consumers in other countries may prefer these species. In addition, sometimes foreign markets are willing to pay higher prices than domestic markets. Participation in the international trade in seafood is critical to U.S. consumers and industry. Approximately 55 percent of the U.S. supply of edible seafood is imported. In 1991, 3,014,819,000 pounds were imported, worth $5,617,887,000, making the United States the world's second largest seafood importing nation (Ref. 42). At the same time, the United States is the world's largest exporter of fishery products. In 1991, the United States exported more than $3 billion worth of seafood, making a significant positive contribution to this country's balance of payments as well as to the many coastal State economies in which these products are produced (Refs. 42 and 43). Our largest market is Japan, followed by the European Community (EC) and Canada. Both Canada and the EC have implemented or are in the process of implementing mandatory HACCP-based seafood inspection systems (Refs. 32 and 44). Given the significance of both international and domestic trade, ongoing efforts to harmonize or make equivalent country inspection systems and requirements takes on great significance. The current multilateral round of trade negotiations under the General Agreement on Tariffs and Trade (GATT) has resulted in further focus on this area. The draft text on sanitary and phytosanitary measures acknowledges the desire of the contracting parties, including the United States, to support ``the use of harmonized sanitary and phytosanitary measures between contracting parties, on the basis of international standards, guidelines, and recommendations developed by the relevant international organizations including the Codex Alimentarious Commission * * *'' (Ref. 45, p. L.35). This move toward harmonization, coupled with the current recommendations of the Codex Committee on Food Hygiene encouraging the international use of the HACCP system (Ref. 46), clearly argue for the adoption of this approach in the United States for seafood. Failure by the United States to adopt a mandatory, HACCP- based inspection system may ultimately undermine its export success, with considerable economic consequences. For example, in addition to the EC, Canada, Iceland, Australia, and many other fishing nations have moved to a mandatory HACCP approach that could affect United States competitiveness in the major seafood markets. The EC is the United States' second largest export market, purchasing $441 million worth of U.S. products in 1991. On July 22, 1991, EC Council Directive 91/493 was issued to set out the conditions for the production and placing on the EC market fish and fishery products (Ref. 44). This Directive requires, as of January 1, 1993, that both member States and third countries: * * * take all necessary measures so that, at all stages of the production of fishery products * * * persons responsible must carry out their own checks based on the following principles: --Identification of critical control points in their establishments on the basis of the manufacturing processes used; --establishment and implementation of methods for monitoring and checking such critical control points; * * * --keeping a written record * * * with a view to submitting them to the competent authority * * *. While the directive provides some flexibility in terms of equivalence, it is clear that the EC is looking for a mandatory HACCP system along the lines proposed in this regulation. Maintaining and expanding this export market is likely to be facilitated if this proposal is adopted. Similarly, ongoing discussions with Canada under the terms of section 708 of the U.S./Canada Free Trade Agreement (FTA) to harmonize or make equivalent the two nations' respective inspection systems and standards have made it clear that this proposed HACCP regulation will significantly facilitate the process (Ref. 47). Canada has recently completed implementation of a mandatory, HACCP-based seafood inspection program. Because Canada is the United States' third largest export market and largest supplier of imported seafood, adoption of an equivalent system would not only achieve the objectives of the FTA but potentially would save resources currently devoted to monitoring shipments between our two countries. Similar potential benefits could be expected under the proposed North American FTA, particularly at this formative stage in that process. Thus, facilitation of international trade is a fourth factor supporting the appropriateness, and thus providing a rational basis, for FDA's proposed course of action. VII. The Proposed Regulations These proposed regulations consist of a subpart of general applicability (subpart A) and one subpart that sets forth specific additional provisions for raw molluscan shellfish (subpart C). The agency is also setting forth guidelines, in the form of appendices, that will provide assistance to processors of cooked, ready-to-eat products (Appendix A), and to processors of scombrotoxin forming species (Appendix B), on how to meet various requirements in subpart A relating to the development and implementation of HACCP plans. The products addressed in the guidelines involve special considerations or special hazards for which additional guidance would be useful. Processors and importers that follow these guidelines will increase the likelihood that FDA will find their preventive controls acceptable. FDA requests comments on the need for, and the substance of, the guidelines that it has set forth. Comments should address whether it would be more appropriate for FDA to adopt the guidelines as regulations. If the comments provide a convincing basis for doing so, FDA will include some or all of the guidelines in the regulations in any final rule that results from this rulemaking. FDA is also including a guideline on how to ensure product integrity relating to economic adulteration (Appendix D). FDA is including this guideline because economic adulteration is a particular problem in the seafood industry. In Appendix 1 to this document, FDA is also providing samples from a package of general guidance, to be published separately, for processors to use in understanding and implementing HACCP principles in their operations. One of these samples is specific guidance on the processing of smoked and smoke-flavored fish. FDA requests comments on whether the latter guidance should remain as such, be provided as guidelines in an appendix to the regulations, or be made mandatory by incorporating them into any final rule that results from this proceeding. A. Definitions The agency is relying generally on the definitions contained in the act, in the umbrella good manufacturing practice guidelines in part 110, and in other agency regulations. The agency is using these definitions because it considers consistency in how it uses terms in its regulations to be necessary and appropriate. Thus, Sec. 123.3(o) is derived from Sec. 113.3(s), and Sec. 123.3(r) is derived from Sec. 110.3(q). Additional definitions are proposed in Sec. 123.3 that are specific to the proposed HACCP program for fish and fishery products. The agency is proposing to define ``certification number'' in Sec. 123.3(a) as a unique combination of letters and numbers assigned to a shellfish processor by a shellfish control authority, usually the State. These numbers are used to identify the processor on tags and labels and in recordkeeping required under proposed Sec. 123.28. States issue certification numbers to processors who receive shellfish from safe sources, keep requisite records of shellfish purchases and sales, and operate in accordance with CGMP and the other certification requirements of the State. This system of State issued numbers is used to identify the approximately 2,000 State certified shellfish dealers that are included on the Interstate Certified Shellfish Shippers List. The agency is proposing in Sec. 123.3(b) to define ``cooked, ready- to-eat fishery product'' as a fishery product that is subjected by a commercial processor to either a cooking process before being placed in a final container, or to pasteurization in the final container, or to both. Cooked, ready-to-eat products undergo a heat treatment by a processor that results in the coagulation of the protein. Because their organoleptic qualities suggest that they are fully cooked, and thus ready-to-eat, these products will likely be eaten without any further heat treatment by the consumer sufficient to eliminate pathogenic microorganisms and preformed toxins. As defined, cooked, ready-to-eat fishery products include products that must be stored either frozen or refrigerated. Products such as canned seafoods that are subjected to a cooking process after being placed in a final container, while technically considered cooked, ready-to-eat products, are not included in the definition because they are virtually sterile in the final container. As used in these proposed regulations, the term applies to cooked, ready-to-eat products that do not receive a heat treatment in the final container by the processor sufficient to destroy all pathogens and create a shelf-stable product that does not need refrigeration. The agency is proposing in Sec. 123.3(c) to define ``critical control point'' for purposes of these regulations as a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard in the final food. This is a modification of the definition of the same term in Sec. 110.3(e). Under that definition, a ``critical control point'' is a point where an improper control could cause, allow, or contribute to ``filth in the final food or decomposition in the final food'' as well as to a ``hazard'' in the final food. Clearly, that definition is intended to apply both to human food safety and to certain quality issues that would not normally cause illness. In this document, FDA is proposing to require the identification of critical control points for safety only and is encouraging, but not requiring, the identification of certain critical control points for hazards not normally related to safety. The modification of the part 110 definition being proposed here represents the least revision necessary to achieve that purpose. The agency is proposing to define ``critical limit'' in Sec. 123.3(d) as a maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk of occurrence of the identified hazard. This definition is consistent with that of NACMCF, which defined ``critical limit'' as ``a criterion that must be met for each preventive measure associated with a critical control point'' (Ref. 34, p. 186), but FDA's proposed definition is somewhat more explanatory. Critical limits can be either maximum values, such as the maximum amount of histamine that can be allowed in a fish, or minimum values, such as the minimum temperature needed during a cooking step to kill pathogens. The proposed definition states that control is for the purpose of minimizing risk. While complete prevention of a hazard is obviously the most desirable of all possible outcomes, the proposed definition recognizes that, in reality, complete prevention cannot always be ensured. A processor can minimize a microbiological hazard with a cooked, ready-to-eat product by proper cooking, but the hazard could still occur if the product is contaminated or otherwise abused elsewhere in the distribution system or in the home. This aspect of the definition is consistent with the view of NACMCF, which states that: ``Each CCP [critical control point] will have one or more preventive measures that must be properly controlled to assure prevention, elimination or reduction of hazards to acceptable levels'' (Ref. 34, p. 196). The agency is proposing in Sec. 123.3(e) to define ``fish'' and broadly to encompass the range of seafood products that are processed or marketed commercially in the United States. Thus, the term ``fish'' includes all fresh or saltwater finfish, molluscan shellfish, crustaceans, and other forms of aquatic animal life. Birds are specifically excluded from the definition because commercial species of birds are either nonaquatic or, as in the case of aquatic birds such as ducks, regulated by USDA. Mammals are also specifically excluded because no aquatic mammals are processed or marketed commercially in this country. ``Fishery products'' in proposed Sec. 123.3(f) are any edible human food product derived in whole or in part from fish, including fish that has been processed in any manner. This definition reflects the tentative conclusion of the agency to propose mandatory HACCP requirements at this time to control hazards associated with processing and importing seafood products intended for human consumption. The proposed definition includes products that contain ingredients other than seafood in keeping with the scope of FDA's regulatory authority. The control of hazards is as important for products that contain ingredients other than fish as it is for products consisting of fish alone. The agency is proposing in Sec. 123.3(g) to define ``harvester'' as a person who commercially takes molluscan shellfish from their growing waters, by any means. Harvester is defined because, under this proposal, this person has responsibility for tagging the product as to where it was harvested and when. Harvesters are expected to have an identification number issued by a shellfish control authority. Harvesting is generally illegal without such a number. The agency is proposing to define the term ``importer'' in Sec. 123.3(h) as the owner of the imported goods or his representative in the United States. This is the person who is responsible for ensuring goods being entered are in compliance with all laws affecting the importation. Importers may not always directly handle the imported food, but they are responsible for the safety and wholesomeness of products they offer for entry into the United States and therefore are subject to part 123. The agency recognizes that the term ``importer'' is often used to describe not only the owner of the goods or his representative in the United States (that is, the importer of record) but also includes freight forwarders, food brokers, food jobbers, carriers, and steamship representatives. These other agents often represent the importer for legal and financial purposes that are not necessarily related to the safety of the product. Therefore, the agency has tentatively concluded that it is inappropriate to focus the HACCP requirements that bear on imports on these persons if they do not have authority to make decisions affecting the product's safety or wholesomeness. FDA is proposing to define a ``lot of molluscan shellfish'' in Sec. 123.3(i) as no more than one day's harvest from a single, defined growing area, by one or more harvesters. This definition establishes the quantity of shellfish that represents a single lot for tagging or labeling purposes. Lot distinctions are needed to differentiate shellfish harvested from different growing areas or at different times. The time limit of one day is imposed because the safety of a harvesting area can change daily as the result of rainfall, tides, winds, and other events that can bring contaminants into the area. The ultimate safety of raw molluscan shellfish is contingent on the water quality of the harvesting area. To ensure product safety, shellfish harvesting areas that are subject to appropriate state control are closed to harvesting within 24 hours of a finding of adverse conditions. The lot definition, coupled with the harvest date on the harvesting tag, provides evidence that the shellfish were harvested when the area was safe and open for harvesting. The agency is proposing in Sec. 123.3(j) that ``molluscan shellfish'' means any edible species, or edible portion of fresh or frozen oysters, clams, mussels, and scallops, except were the scallop product consists entirely of the shucked adductor mussel. The distinction between molluscan shellfish and crustacean shellfish, which include crabs, shrimp, and lobsters, is made because molluscan shellfish are commonly eaten whole and raw, while crustacean shellfish are not. The safety of molluscan shellfish therefore reflects the quality of the waters from which they are harvested and requires special public health controls. Furthermore, the agency is proposing to amend the definition of ``shellfish'' in Sec. 1240.3(p) (21 CFR 1240.3(p)) to make it consistent with the proposed definition in Sec. 123.3(j). The agency is proposing to amend the term ``shellfish'' in Sec. 1240.3(p) to read ``molluscan shellfish'' to make the terms consistent between parts 123 and 1240. Because the term shellfish in its common usage, i.e., an edible mollusk or crustacean, includes crabs and lobsters, the agency believes that it is necessary to be more specific and accurate in its definition and consequent application of the requirements in its regulations. The proposed requirements for tagging do not apply to crabs and lobsters or to scallops when the final product is the shucked adductor muscle only. The agency is proposing to expand the definition in Sec. 1240.3(p) to include scallops to make it consistent with the definitions in proposed part 123 and with requirements under NSSP. The agency is proposing to define ``potable water'' in Sec. 123.3(k) as water that meets EPA's primary drinking water regulations as set forth in 40 CFR part 141. Those regulations provide limits for certain microbiological, chemical, physical, and radiological contaminants that can render water unsafe for human consumption. The proposed definition is slightly different from the definition of ``potable water'' in Secs. 1240.3(k) and 1250.3(j) (21 CFR 1250.3(j). That definition also references the regulations of EPA in 40 CFR part 141 but further includes FDA sanitation requirements in 21 CFR parts 1240 and 1250. Those sanitation requirements apply to interstate travel conveyances that must take on water at watering points. Such requirements are not relevant to these proposed regulations and thus were not included in the proposed definition. FDA is proposing to define ``processing'' and ``processor'' in Sec. 123.3(m) and (n) broadly to ensure the safety of seafood through the application of HACCP principles throughout the seafood industry. The definition of ``processor'' is intended to include all seafood processors that handle products in interstate commerce, such as shuckers and other processors of raw molluscan shellfish, factory ships, packers, repackers, wholesalers, and warehouses. Those who process low acid canned foods are also included, even though they are subject to the HACCP controls of part 113. Those controls are targeted toward a limited number of safety hazards. These proposed regulations require that processors apply HACCP controls to all likely safety hazards. Consistent with the regulations at part 113, the proposed definition of ``processor'' also includes persons engaged in the production of foods that are to be used in market or consumer tests. FDA has tentatively concluded that HACCP controls are needed for such products because the hazards associated with them are no different from those that can affect other commercial products. There are, however, certain handlers of seafood that are not included in the coverage of the proposed definition. Fishing vessels that essentially only harvest are not covered by the proposed HACCP regulations. As explained earlier, FDA has traditionally refrained from directly regulating fishing vessels. The agency anticipates that the regulations being proposed here would affect vessels indirectly through processor and importer controls over raw materials and imported shipments, e.g., preventive controls such as the purchasing of raw materials only from fishing vessels that engage in proper sanitation and time/temperature practices and that harvest only from approved areas. Transportation companies that carry, but do not otherwise process, fish and fishery products are also outside the scope of the proposed definition, although the agency expects that transporters will be affected indirectly in the same manner as fishing vessels (see also Sec. 110.93). FDA invites comment on this aspect of the coverage of the proposed regulations. Proper refrigeration during transport is important for the safety of scombroid species products and of cooked, ready-to-eat products. Time and temperature conditions during shipment can also affect decomposition related to other factors bearing on seafood quality. These proposed regulations will affect transportation companies indirectly through the preventive controls the processor or importer will need to impose to ensure that the raw materials or imported shipments that it receives are free of relevant hazards and have been appropriately handled. FDA invites public discussion on whether this approach is adequate, and, if not, whether HACCP requirements should be applied directly to transportation companies. This issue is complex, especially because it is not unusual for transporters to deliver a variety of food products, including seafood, to several consignees during a single shipment. The agency has also tentatively decided to exclude retail establishments from the definition of ``processor.'' As with fishing vessels, FDA has traditionally exercised enforcement discretion with regard to retail establishments. The number of retail establishments in this country--literally in the hundreds of thousands--would totally overwhelm any rational Federal inspection system. FDA has traditionally provided training and other forms of technical assistance to States and local governments to inspect retail food establishments through the agency's retail Federal/State cooperative program. A major part of that cooperative program involves the development of model codes, some of which have been widely adopted by State and local governments. FDA is now consolidating those model codes into a single, updated food code for the retail sector. Appropriate HACCP-based controls are included to address seafood hazards at retail. Consequently, FDA will continue to operate through the Federal/State cooperative mechanism and has not included a retail component in proposed part 123. FDA requests comments on this tentative approach. States are strongly encouraged, however, to consider how the principles in these regulations could be applied to seafood at retail and to shift to HACCP-type inspection systems as appropriate. Because of the high perishability of fresh seafood and the sometimes lengthy and complex distribution chain, these products can have relatively short shelf lives by the time they reach fresh fish counters and restaurants. In addition, seafood can be subject at retail both to cross-contamination because of poor handling practices and to species substitution. Improper handling of seafood and other problems at retail have been documented in recent years. NAS has concluded that a significant number of reported acute health problems were likely linked to handling and preparation practices in food service establishments (Ref. 7, p. 27). The February, 1992 edition of Consumer Reports magazine reported on a number of such problems with regard to seafood that were observed in retail establishments. A number of studies have found lack of adequate temperature controls in retail facilities (Ref. 48, p. 75). The agency is proposing to define ``shellfish control authority'' in Sec. 123.3(p) as the government entity responsible for implementing a comprehensive shellfish sanitation program. The shellfish control authority, among other things, is responsible for classifying shellfish growing waters, performing inspections of shellfish processors, and issuing certification numbers to shellfish processors. FDA relies on recognized governmental public health and food control agencies, both domestic and foreign, to carry out these functions. The agency is proposing to define ``shellstock'' in Sec. 123.3(q) as meaning raw, in-shell molluscan shellfish. This specific product form designation is needed because the applicability of the tagging, labeling, and recordkeeping requirements proposed in Sec. 123.28(b) and (c) is determined by whether the product is shellstock or shucked product, respectively. The agency is proposing to define ``shucked shellfish'' in Sec. 123.3(s) as meaning molluscan shellfish that have one or both shells removed. The labeling and recordkeeping requirements proposed in Sec. 123.28(c) apply to shucked shellfish. The agency is proposing to define ``tag'' in Sec. 123.3(t) as a record of harvesting information attached to a container of shellstock by the harvester or processor. Under proposed Sec. 1240.60(b), the tag or bill-of-lading will identify the processor, harvester, date of harvest, and State, including the specific location of harvest. Most shellfish-producing States and countries currently require that shellfish harvested in their waters bear documentation with such information. This information is the minimum necessary to permit ready identification of site and time of harvest of the shellfish. Because raw molluscan shellfish directly reflect the quality of the harvesting area, this information is necessary to provide assurance that the shellfish were harvested from an area that was safe and open for harvesting. B. Purpose and Criteria Section 123.5(a) of the proposed regulations references the umbrella CGMP guidelines in part 110 as providing general guidance with regard to such matters as facility design, materials, personnel practices, and cleaning and sanitation procedures. Because part 110 provides guidance of general applicability to all foods, the agency intends that this guidance will continue to be valid for seafood processors when the proposed regulations at part 123 are issued in final form. Proposed Sec. 123.5(b) makes clear that the purpose of subpart A of part 123 is to set forth requirements specific to the processing and importation of fish and fishery products. C. HACCP Plans 1. Summary FDA is proposing to require in Sec. 123.6 that commercial processors and importers of fish and fishery products develop and implement HACCP plans in keeping with Principle 6 of the NACMCF discussed previously. Development and implementation of an HACCP plan requires that processors think through the entire process flow from raw materials to finished product shipping to ensure that safety hazards are controlled by design, and that they operate that process as a matter of daily routine. For importers, the thought process will begin with a decision from whom and from where to buy fishery products and follow through to arrangements for shipment to the United States, storage in the United States, and end when the product leaves the control of the importer. The plan provides the structure for the preventive controls, including the recordkeeping associated with those controls, that a processor or importer is to employ. In summary, FDA has tentatively concluded that the essential elements of this structure must include: (1) The identification of hazards to ensure that the processor or importer knows what the hazards are, so that it controls them by design rather than by chance (proposed Sec. 123.6(b)(1)); (2) the identification of critical control points to ensure that the processor or importer knows where to monitor to prevent or minimize the occurrence of the relevant hazard (proposed Sec. 123.6(b)(2)); (3) the identification of critical limits that must be met at each critical control point, so that the processor or importer has objective standards in place by which to determine whether it is controlling the relevant hazard (proposed Sec. 123.6(b)(3)); (4) the identification of procedures for how and when the processor or importer will monitor the critical control points to ensure both that monitoring is done as a matter of routine, and that it is done in an appropriate manner and with sufficient frequency to establish preventive control (proposed Sec. 123.6(b)(4)); and (5) a recordkeeping system for that monitoring that will establish for the processor's or importer's benefit that it is effectively implementing a system of preventive controls, and record how those controls are operating over time (proposed Sec. 123.6(b)(5)). The recordkeeping system is the key to HACCP. As explained above, the records will enable the processor or importer, and ultimately the regulator, to see the operations of the processor or importer through time, rather than only how they are functioning at a particular moment in time. Among other things, HACCP records can reveal trends that might otherwise go undetected until significant problems occurred. All of these requirements reflect the HACCP principles developed by NACMCF. FDA is not proposing to require that the HACCP plan be signed by any official of a company, but invites comment on the merits of such a requirement in the final regulations as a means of both ensuring and demonstrating formal adoption of the plan by that company. FDA also invites comment on who in the firm would be the appropriate individual to sign the plan. 2. Guidelines and Other Assistance FDA recognizes that HACCP plans will vary in complexity, from those having many critical control points, such as plans for multicomponent, ready-to-eat products, to those having only a few critical control points, such as a plan for a fish filleting plant. Plan development can be facilitated by technical assistance from many sources and by the detailed advice provided in the literature. NACMCF, for example, has recommended that, to facilitate the development of HACCP plans, processors should create an HACCP team, identify the intended use and likely consumers of the food, and prepare a flow diagram of the entire manufacturing process to help identify critical control points. The agency favors simplicity and the rapid development of HACCP plans without undue expense. The appendices at the end of the proposed regulations are intended to facilitate plan development by setting forth certain critical control points, critical limits, controls, and records that, if incorporated into or prepared under a HACCP plan, would be acceptable to the agency for the types of products mentioned. To further facilitate the development of HACCP plans, FDA intends to issue separate HACCP guidance for seafood that will provide information on hazards and appropriate controls by species and by product type. The guidance will provide a broad spectrum of information from which firms will be able to identify likely hazards and critical control points that apply to them. The agency believes that the number of critical control points will range, roughly, between 2 and 12 per product. The guidance will also contain a fill-in-the-blank type of HACCP plan with instructions on how to complete the plan based on information in the guidance. The agency has tentatively concluded that a plan that follows this model is likely to be acceptable to FDA. The agency is including samples of the guidance it is developing in Appendix 1 to this document. FDA intends to issue a separate draft guidance document for public comment and to make the completed guidance available to the public at the time that the regulations are finalized. In addition, seafood trade associations, university Sea Grant extension offices, and others have already developed work sheets and other aids to facilitate HACCP planning for seafood. Industry members are encouraged to contact their trade associations and state universities or Sea Grant extension offices on such matters. 3. Effective Date Even with these forms of assistance, however, FDA recognizes that HACCP plans cannot be written and implemented overnight. As has already been discussed, the HACCP system of controls can involve new ways of thinking and performing on a routine basis. Consequently, FDA is proposing that these regulations will become effective 1 year after issuance of the final rule in this proceeding. The agency has tentatively concluded that this period of time is sufficient to permit the development and implementation of HACCP plans by the industry. FDA specifically invites comment on whether 1 year will be adequate. The agency's objective is to provide enough time to permit processors and importers to understand HACCP, analyze the relevant hazards, and develop an appropriate HACCP plan, but also to avoid unnecessary delay. After the proposed effective date, inspection of HACCP plans will occur as part of routine, mandatory plant inspections and import examinations. FDA is not proposing to require that HACCP plans be submitted to FDA in advance, or that preapproval by FDA be a condition of their adoption or implementation. FDA is not requiring preapproval for two reasons. First, HACCP plans can only properly be judged in the context of the facility itself. Thus, while FDA investigators will consider the adequacy of the plan during their inspections, preapproval does not seem warranted. Second, the agency simply does not have the resources to make preapproval a requirement. Given the protections that are built into the HACCP approach, FDA tentatively finds that preapproval is not necessary to ensure that fish and fishery products are not produced under conditions whereby they may be adulterated under section 402(a)(4) of the act. 4. Location and Product Type FDA is proposing in Sec. 123.6(a) to require that every processor and importer have and implement an HACCP plan that is specific both to each location where that processor engages in processing and to each kind of fish and fishery product being processed. A plan should be specific to each location because the likely hazards, critical control points, critical limits, and monitoring procedures can vary from one facility to the next depending on such factors as type of equipment, conditions and procedures, and location. A plan also should be specific to each type of fish and fishery product for the same kinds of reasons. Hazards can vary depending on species, location of catch, and other factors. FDA does not intend, however, to require a processor or importer to write a separate plan, or separate part of a plan, for each fish and fishery product it handles if the likely hazards, critical control points, critical limits, and monitoring procedures are identical for each of them. For example, the preventive controls necessary to ensure safety for most deep water species of finfish from the north Atlantic may be virtually identical. The agency has tentatively concluded that, in such cases, a processor or importer may group the fish or fish products together in an HACCP plan. 5. Safety Hazards Only FDA is proposing to require at Sec. 123.6(b)(1) that HACCP plans identify the human food safety hazards that must be controlled for each fish and fishery product being processed by a processor or importer. There exists a range of opinion on whether HACCP should apply solely to safety hazards, as this provision proposes to require, or whether HACCP should apply to other types of hazards, such as decomposition not normally associated with illness in humans. One school of thought holds that HACCP should apply to safety hazards only in order to keep it focused and to not overwhelm operators with an unnecessarily large number of critical control points that have no bearing on the primary concern of safety. Another view holds that, for seafood at least, HACCP-type controls can be applied to various consumer risks without generating an excessive number of critical control points. The Codex Committee on Food Hygiene came to the latter conclusion (Ref. 46), as did NOAA as a result of its experiences during the MSSP (Ref. 35, p. 70). Partly for that reason, the FDA/NOAA HACCP pilot programs involved HACCP controls for safety and HACCP-type controls for other hazards as well. For purposes of these proposed regulations, however, FDA's application of HACCP is intended for the efficient enforcement of section 402(a)(1) and 402(a)(4) of the act, which applies to products that contain substances that may render the product injurious to health and to processing conditions that are insanitary and that could render a product injurious to health. Consequently, FDA is proposing to require that HACCP plans include identification of hazards that could affect human food safety only. To facilitate the production of such plans, FDA has listed in proposed Sec. 123.6(b)(1) the types of hazards that have been associated with seafood (see section II.C. of this document for a discussion of these hazards). All of these hazards are identified and discussed in the NAS report on seafood safety (Ref. 7). Processors and importers should identify in their written plans only those safety hazards that are reasonably likely to occur, rather than every conceivable hazard no matter how theoretical or remote. This view is in keeping with NACMCF's recommendation that firms conduct a hazard analysis and then give no further consideration to hazards that are unlikely to occur (Ref. 34, p. 189). FDA has tentatively concluded that processors and importers should not be required to establish controls and regularly monitor for hazards that are highly unlikely to occur in the absence of those controls. If, for example, chemical contaminants have never been found, or have only been found in amounts significantly below levels of public health concern in a species from a particular location, processors and importers need not identify chemical contaminants as a hazard that must be controlled for that fish. As indicated earlier in this preamble, FDA intends to issue a guidance document that will cover possible environmental and processing hazards for fish and fishery products as well as types of controls that can be applied to those hazards. The agency anticipates that it will update that guidance periodically as new controls (or new hazards) are identified or established. FDA cannot reasonably expect processors and importers to exercise controls for hazards that are beyond the scope of current scientific knowledge. The agency does expect processors and importers to demonstrate that they are taking precautions that are reasonable in light of available information, and that they are adopting new controls as those controls are developed and accepted. For example, the controls for Vibrio bacteria in raw molluscan shellfish, which can cause serious illness and death in certain at-risk populations, are the subject of continuing research at FDA and elsewhere. Short of a complete ban on harvesting, there is no known control that would prevent the presence of Vibrios in molluscan shellfish. Moreover, the infectious dose, that is, the number of Vibrios necessary to cause illness, is unknown. Because these bacteria occur naturally in the environment and are ubiquitous, controls that are employed to prevent sewage-related viruses from entering molluscan shellfish are not relevant to Vibrios. It is known, however, that proper temperature controls from the time of harvest onward can at least limit the growth of these bacteria (Ref. 49). FDA believes that such controls are reasonable and should be applied now. (In fact, temperature controls have long been a feature of the National Shellfish Sanitation Program (NSSP).) Of the hazards listed in proposed Sec. 123.6(b), pesticides and drug residues (proposed Sec. 123.6(b)(1)(iv) and (b)(1)(v)) are forms of chemical contaminants (proposed Sec. 123.6(b)(1)(iii)) but are listed separately because they can be of special concern in aquaculture-raised species. These fish generally have a greater likelihood of being exposed to agricultural run-off than wild ocean stocks (Ref. 50, pp. 11 and 12). Aquaculture-raised fish are known to be fed drugs for various purposes. Drug residues in edible tissues can be a public health concern. Decomposition, listed in proposed Sec. 123.6(b)(1)(vi), is a known hazard in those species that can generate scombrotoxin when they decompose; otherwise, it is regarded as a quality problem. Parasites (proposed Sec. 123.6(b)(1)(vii)) are not a hazard if killed during cooking but can be a hazard in finfish consumed raw, unless that fish is commercially frozen. Unapproved direct and indirect food and color additives (proposed Sec. 123.6(b)(1)(viii)) are a potential hazard with most any food. 6. Critical Control Points Consistent with the HACCP principles identified by NACMCF, FDA is proposing to require in Sec. 123.6(b)(2) that critical control points be identified for each of the hazards that the processor or importer has identified. Hazards may be caused by improper processing or by events outside the processor's or importer's direct control. To control the latter type of hazard, that is, environmental hazards and hazards that may be caused by poor handling prior to receipt of fish or fishery products by the processor or importer, the point of receipt by the processor or importer represents a critical control point. As indicated previously in this preamble, the processor or importer may need to ensure that it obtains imported shipments or raw materials only from harvesters, transporters, and others who can demonstrate that they also have exercised appropriate controls. The hazards that may be caused by both improper processing and events outside the plant are controlled by the critical limits, monitoring, control procedures, and recordkeeping that are done as part of HACCP. 7. Critical Limits In Sec. 123.6(b)(3), consistent with NACMCF principles, FDA is proposing that processors and importers identify critical limits in the plan that must be met at each critical control point. Critical limits must be met to ensure that the relevant hazard is avoided. Thus, some critical limits can be set to reflect regulatory levels established by FDA in the form of action levels, regulatory limits, and tolerances for such contaminants as pesticides, histamine, and other contaminants. FDA intends to compile all such levels in the guidance document described earlier. Other critical limits can be set in consultation with outside experts, in keeping with the longstanding practice for low acid canned foods. For example, as explained later in this preamble with respect to cooked, ready-to-eat products, there exist a range of possible cooking time-temperature combinations that will deactivate pathogens during the cooking step, depending on the type of equipment being used by the processor and the size and species of fish being cooked. The existence of a range of effective cooking time-temperature combinations convinced FDA not to establish specific cooking time-temperatures for industry in the regulations for low acid canned foods. Rather, FDA decided to rely on outside experts and on research within the scientific community to establish cooking times and temperatures for these products. FDA is not proposing specific cooking time-temperature requirements for most seafood products (although FDA is providing guidance on time, temperature, and salinity parameters for smoked and smoke-flavored fish, as is fully explained in Appendix 1 to this document) for the same reason. 8. Monitoring and Control Procedures Proposed Sec. 123.6(b)(4) requires that the processor or importer identify in the HACCP plan the procedures that it will use to control and monitor each critical control point. Monitoring steps are necessary to ensure that the critical control point is in fact under control and to produce an accurate record of what has occurred at the critical control point (Ref. 34, p. 197). Among the procedures that are to be used under proposed Sec. 123.6(b)(4) is monitoring of the consumer complaints received by the processor. While the goal of an HACCP system is to prevent all likely hazards from occurring, no system is foolproof. Consumer complaints may be the first alert that a processor has that deviations are occurring that are not being prevented or uncovered by the processor's HACCP controls. FDA has tentatively concluded, therefore, that each HACCP system should take advantage of consumer complaints as they relate to the operation of critical control points. Proposed Sec. 123.6(b)(4) also requires that procedures for controlling and monitoring critical control points must include calibration of process control instruments and validation of software for computer control systems, as appropriate. For a processor's preventive controls to work, the instruments and equipment that it relies upon in monitoring critical control points, such as thermometers, temperature-recording devices, and computer software, must be accurate and reliable. FDA has tentatively concluded that the best way to ensure such accuracy and reliability is to require that the processor's monitoring procedures include steps necessary to verify the reliability of these instruments and devices. 9. Recordkeeping As explained above, a HACCP system will not work unless records are generated during the operation of the HACCP plan, and these records are maintained and are available for review (see section IV.A.6. of this document). Thus, FDA is requiring in proposed Sec. 123.6(b)(5) that the HACCP plan provide for a recordkeeping system that will document the processor's or importer's monitoring of the critical control points. Proposed Sec. 123.6(b)(5) also requires that HACCP records contain the actual values obtained during monitoring, such as the actual temperatures and times. FDA has tentatively concluded that it is not possible for the processor to derive the full benefits of its HACCP system, nor is it possible for FDA to verify the operation of the system, without actual values. Notations that refrigeration temperatures are satisfactory or unsatisfactory, without recording the actual temperatures, are vague and subject to varying interpretation and thus will not ensure that preventive controls are working. Also, it is not possible to discern trends without actual values. In addition, proposed Sec. 123.6(b)(5) requires that HACCP records include the actual consumer complaints that may have been received by the processor or importer relating to the operation of critical control points or possible critical limit deviations. FDA has tentatively concluded that it may be necessary on occasion for it to review these complaints in order to be able to validate whether the firm is taking necessary steps to review controls and correct deviations as necessary in response to consumer complaints. It is not FDA's intent to gain unlimited access to industry's consumer complaint files through this proposal or to engage in ``fishing expeditions'' through consumer complaint files. Only those consumer complaints relating to the operation of the HACCP critical control points need be included as HACCP records. FDA's interest is solely in verifying that the HACCP system is working as it should. The agency understands the sensitivities associated with consumer complaint records and invites comments on this aspect of the proposal. 10. Nonsafety Hazards Proposed Sec. 123.6(c) encourages, but does not require, processors and importers to include in their plans controls for hazards other than hazards to health. Examples listed in Sec. 123.6(c)(1)(i) and (ii) are decomposition not associated with human illness and economic adulteration. FDA is not requiring processors and importers to include nonsafety hazards in their HACCP plans for reasons stated previously. However, the agency is encouraging processors and importers to apply HACCP principles to these nonsafety hazards, and to control them in the same manner that processors and importers control safety hazards (see proposed Sec. 123.6(c)(2)), because they are common problems in the seafood industry. FDA has included a guideline on economic adulteration with these proposed regulations (see Appendix D). Despite the fact that these proposed regulations do not require HACCP controls for nonsafety hazards, such hazards as economic adulteration, decomposition not normally associated with human illness, general unfitness for food, and misbranding, constitute violations of the act and are subject to regulatory action by FDA (see sections 402(a)(3) and 403 of the act (21 U.S.C. 343). Inspections by FDA investigators will continue to consider and enforce these provisions of the act. D. Corrective Actions FDA is proposing in Sec. 123.7 to require that deviations from critical limits trigger a prescribed series of actions by a processor or importer, including determining the significance of the deviation, taking appropriate remedial action, and documenting the actions taken. This proposed provision is consistent with the HACCP principles enunciated by NACMCF (Ref. 34). First, under proposed Sec. 123.7(a)(1), any critical limit deviation will require the segregation and holding of the affected product until the significance of the deviation can be determined. This step is necessary to ensure that products that may be injurious to health do not enter commerce until the impact of the deviation on safety has been determined, and the safety of the product assured. Second, under proposed Sec. 123.7(a)(2), the processor or importer must actually determine the effect of the deviation on safety, and third, under proposed Sec. 123.7(a)(3), it must take whatever corrective actions are necessary with respect to both the affected product and the critical control point at which the deviation occurred, based on that determination. Some deviations, especially if they are caught quickly, will not adversely affect safety. For example, if a refrigeration unit fails, but product being stored there is moved to a functioning unit before any appreciable warming of the product can occur, safety will not have been affected. FDA is proposing to require in Sec. 123.7(a)(2) that the safety determination be made by an individual who has successfully completed training in HACCP principles (see proposed Sec. 123.9). FDA has tentatively concluded that this requirement is necessary to ensure that the person who is reviewing the significance of the deviation understands the possible consequences of a processing deviation and knows how to take appropriate measures in response to a deviation. FDA does not expect that a processor or importer will be able, without assistance, to determine the public health consequences of every possible deviation. The required training will, however, provide the processor or importer with information about when and how to obtain the assistance of an analytical laboratory, outside expert, State regulatory authority, or FDA district office in determining the proper course of action. FDA is proposing to require in Sec. 123.7(a)(4) and (a)(5) that the processor or importer review the process and the HACCP plan to determine whether the deviation reveals the need to modify the process or the plan, or both, and to make such modifications as may be needed. It is critically important that a processor or importer learn as much as possible from the occurrence of a deviation and take steps to ensure that it will not be repeated. The plan should be a living document that the processor or importer should modify and update as circumstances warrant. These proposed requirements will ensure that the processor and importer connect day-to-day processing and other operations to the plan. Each modification is required to be noted, dated, and maintained as part of their HACCP records. FDA is proposing to require in Sec. 123.7(b) that when a processor or importer receives a consumer complaint that may be related to the performance of a critical control point or that may reflect a critical limit deviation, it take appropriate steps to determine whether a deviation or other system failure has occurred that warrants remedial action and take such remedial action that appears to be warranted under Sec. 123.7(a). The importance of consumer complaints has been discussed above. FDA recognizes that segregation and holding of the affected product will not always be feasible or warranted in response to a consumer complaint. In many cases, there will be no product to hold because all of the product in question will already be in commerce. In other cases, a processor or importer may be able to determine very quickly whether a deviation has actually occurred. FDA is proposing in Sec. 123.7(c) to require that processors and importers clearly document all of the steps that they take in response to a critical limit deviation or a consumer complaint and include that documentation as part of their HACCP records. FDA has tentatively concluded that the processor, the importer, and FDA will benefit from this requirement. Documentation helps processors and importers to think the whole process through in a thorough and methodical way and to establish to their own satisfaction that they have taken proper steps. Documentation enables the regulatory agency to determine whether the processor or importer is able to regain control once a deviation occurs and to ensure that potentially unsafe products are being prevented from entering commerce or at least quickly removed from commerce. The documentation that FDA is proposing to require of the processor's or importer's response to the consumer complaints covered by Sec. 123.7(b) will enable the processor, the importer, and FDA reviewers to determine whether those consumer complaints are receiving appropriate attention in a timely manner. The documentation should be clear enough to allow a determination of the nature of the complaint and of the time it took from the receipt of the complaint for processor or importer to review it and to take any necessary corrective actions. FDA may choose on occasion to review a limited number of consumer complaints to match against the documentation maintained by the processor or the importer. There is a strong view in the HACCP literature (see e.g., Ref. 51), which is reflected in one of NACMCF's seven principles listed above, that processors should actually have a plan describing how they will handle deviations, and that this plan should be part of the overall HACCP plan. FDA believes that there is merit in this view and encourages processors and importers to think through how they will handle deviations that may occur. The agency has tentatively concluded, however, that the proposed requirements in Sec. 123.7 represent the minimum requirements necessary to ensure that processors and importers respond effectively to deviations that could affect safety, and that given these provisions, it is not necessary to require that a specific plan be formulated and adopted. FDA requests comments on this tentative conclusion. E. Records As discussed above, maintenance of appropriate records is fundamental to the success of an HACCP system (see section IV.A.6. of this document). In recognition of this fact, FDA is proposing to require in Sec. 123.8 that HACCP records contain certain necessary information; that processors review records of monitoring and related activities before distributing the products to which the records pertain; that processors and importers retain records for specific periods of time; and that FDA investigators be given access to HACCP records. FDA is proposing in Sec. 123.8(a) that records involving observations or measurements during processing, corrective actions, and related activities, contain the identity of the product, product code, and date that the record was made. The purpose of this provision is to ensure that both the processor or importer and the regulator can readily link a record to a product and to the timeframe in which the product was manufactured. The linkage of the record to product is especially important when there has been a deviation at a critical control point. The agency has tentatively concluded that including the identity of the product, product code, and date of the activity that the record reflects provide the minimum necessary information to enable the processor or the importer and, ultimately, the regulator to determine what product may have been affected and to take appropriate action, such as withholding the product from distribution or recalling it from distribution. Dates also help discern trends over time. Even when no deviation has occurred, the information will enable both the processor and the regulator to identify factors that may help prevent problems in the future. In Sec. 123.8(a), FDA is also proposing to require that information be recorded at the time that it is observed, and that each record be signed by the operator or observer. It is important that information relating to observations be recorded immediately to ensure accuracy. The record should be signed by the individual who made the observation to ensure responsibility and accountability. Also, if there is a question about the record, a signature ensures that the source of the record will be known. FDA is proposing to require in Sec. 123.8(b) that records receive a second review by an individual trained in accordance with Sec. 123.9, for verification purposes, before the product is distributed into commerce. The purpose of this review is to ensure that the processor or importer verifies that employees are recording data in HACCP records, and that deviations from critical limits are being caught before products that may have been affected can enter commerce. The agency is proposing to require that this records verification be performed by a trained individual to ensure that the records are reviewed by a person who understands the HACCP system, understands the significance of a processing deviation, and knows how to respond if a deviation occurs. FDA is proposing in Sec. 123.8(c) to require that HACCP records be retained for at least 1 year after they are prepared for refrigerated products and for at least 2 years after they are prepared for frozen or preserved (i.e., shelf-stable) products. These timeframes are based on the length of time that these products can be expected to be in commercial distribution (Ref. 52; Ref. 53, pp. 72-73) plus a reasonable time thereafter to ensure that the records are there when the FDA inspector performs the next inspection. They are the same timeframes as now provided for in the Manual of Operations of the NSSP for the retention of records for raw molluscan shellfish. Similarly, FDA is also proposing to require in Sec. 123.8(c) that the processor retain any records relating to the general adequacy of the equipment or processes being used by the processor, including the results of scientific studies and evaluations to determine adequacy, for 1 year beyond the applicability of these records to refrigerated products being produced by the processor, and for 2 years beyond the applicability of the records to frozen or preserved products being produced by the processor. The processor may need to obtain a written scientific evaluation of a process, such as a cooking, pasteurization, or cooling process, to ensure that the process it is using is adequate to destroy pathogens or to prevent their growth. Such an evaluation may also be necessary to ensure the adequacy of the cooking, pasteurizing, or refrigerating equipment that the processor is using. (See the preamble discussion on cooked, ready-to-eat fishery products.) As with processing records, these records should be retained for a period of time that reflects the period that the products to which they relate can be expected to be in commercial distribution. FDA recognizes that some processing plants may be closed on a seasonal basis. Given the nature of the HACCP system, however, FDA may choose to inspect at least the records of a plant even if the plant is not in operation. Therefore, FDA is providing in proposed Sec. 123.8(c) that if a processing facility is closed between seasonal packs, the records may be transferred to some reasonably accessible location during the period of closure. FDA is proposing to require in Sec. 123.8(d) that HACCP plans and records be available for review and copying by authorized agency employees at reasonable times. As already discussed, the agency's access to HACCP records is essential to ensure that the HACCP system is working, and that the safety of seafood is being ensured by design. FDA's authority to require maintenance of these records, and to provide for agency access to them, is fully supported by the holding in National Confectioners Association v. Califano, 569 F.2d 694-95 (D.C. Cir. 1978). In this case, the court recognized FDA's authority to impose recordkeeping requirements on firms that process foods when such requirements effectuate the goals of the act. See also Toilet Goods Association v. Gardner, 387 U.S. 158, 163-164 (1967). The importance of the records in ensuring that fish and fishery products will not be rendered injurious to health has been fully discussed. FDA access to these records will expedite the agency's efforts to ensure that the fish and fishery products in interstate commerce are not adulterated and to identify any such products that are. FDA is aware that there is substantial public interest in the extent to which industry-generated HACCP records could or should be publicly available. As FDA understands it, the argument in favor of availability is that where an inspection system to protect the public health relies heavily on records, those records should be public to the maximum extent possible. The arguments in favor of protection of records, on the other hand, are based on concerns about advantages to competitors from disclosure and on the risk that the records will be otherwise misused if they become public. FDA invites comment on the general question of public disclosure of HACCP records and on the agency's preliminary analysis of their availability, as follows. FDA has longstanding explicit statutory access to certain industry records during inspections involving infant formula, drugs, and devices and has access by regulation to certain processing records during inspections of low acid canned food processors. The agency has the right to copy and take possession of these records but does not routinely do so. FDA typically copies and takes possession of records only when they may be needed for regulatory purposes. As a preliminary matter, FDA expects to continue that practice with regard to seafood HACCP records. The public availability of those HACCP records that FDA would possess as a result of copying during an inspection would be governed by section 301(j) of the act and by the Freedom of Information Act (FOIA) and regulations issued pursuant to it by the Department of Health and Human Services (DHHS) and FDA. Section 301(j) of the act expressly prohibits FDA from disclosing trade secret information obtained during the course of an inspection. The FOIA regulations also say that FDA will not divulge either trade secret or commercial confidential information. As a preliminary matter, HACCP plans and monitoring records appear to fall within these two categories of protected records. As a consequence, FDA may well have little discretion in this area. Moreover, under DHHS' FOIA regulations, processors may be entitled to challenge in court a pending disclosure of records on the grounds that the records to be disclosed are commercial confidential or trade secret. As an additional matter, there are significant legal and practical questions as to whether FDA has the authority to require disclosure of industry records that are not in FDA's possession. As discussed elsewhere in this document, FDA does not contemplate the submission of HACCP plans or other records to FDA under these proposed regulations. The preapproval of HACCP plans by FDA (and thus the submission of HACCP plans to FDA) is simply not practical. The agency has tentatively concluded that HACCP plans and monitoring records will be reviewed on site by agency investigators as part of FDA's normal inspection regime. FDA is proposing in Sec. 123.8(e) to exempt tags as defined in Sec. 123.3(t) from the recordkeeping requirements of Sec. 123.8. While the information on tags must be saved in accordance with the proposed requirements of this section and Sec. 123.28(d), the agency has tentatively concluded that it would be burdensome for processors to be required to retain the tags themselves for extended periods of time. NSSP now provides that processors are to retain tags for 90 days. F. Training Proposed Sec. 123.9 requires that each processor and importer employ at least one individual who has successfully completed a training course on the application of HACCP to fish and fishery products processing. The agency has tentatively concluded that training is critical to the successful implementation of HACCP systems in the seafood industry. Based on experience obtained during the FDA/NOAA HACCP pilot programs in 1991-92, the agency believes that a significant portion of the seafood industry will be unprepared to meet the requirements of a mandatory HACCP program without some training. As discussed earlier, the pilot program revealed a general lack of understanding of the preventive nature of HACCP, including misunderstandings about how to establish critical limits, control measures, corrective actions, and recordkeeping procedures (Ref. 40). A similar concern that the industry did not understand the application of HACCP principles formed the basis for the training requirements in the agency's regulations for low acid canned foods. Improvements in canning operations can be attributed in significant measure to the success of the training programs that were established to implement that requirement (Ref. 54). NAS concluded that the successful application of HACCP principles to low acid canned foods was substantially the result of the training requirement in the regulations for those products (Ref. 36, p. 309). The CGMP regulations for foods in part 110 also call for training in appropriate food protection principles (Sec. 110.10(c)). The often seasonal nature, remote location, and small size of many seafood processors also support the need for formalized training. All of these conditions result in difficulty recruiting highly qualified management and supervisory staff. Thus, FDA has tentatively concluded that proposed Sec. 123.9 is necessary to ensure that seafood processors and importers employ at least one person who is familiar with HACCP. These regulations propose to require at Sec. 123.9 that the person or persons at each importing and processing establishment who has received training be responsible for reviewing records of critical control point monitoring, recognizing critical limit deficiencies, and assessing the need for corrective actions relative to the product in question and the HACCP plan itself. While it is the intent of the agency to provide as much guidance as possible to assist processors and importers, these activities require specialized training in the principles of HACCP, various aspects of food science, and the criteria of existing regulations and guidelines. The agency anticipates that 2- or 3-day training sessions, modeled after the Better Process Control Schools currently in place for low acid canned food and acidified food manufacturers, will be provided by various public and semiprivate institutions. The uniformity of this training can be assured by a review of their contents and by periodic onsite monitoring by the agency. Thus, FDA is proposing to require that the program of instruction be approved by the agency. While 2- or 3-day courses may well become the norm, FDA invites comment on whether the training requirement could be satisfied by different gradations of training, depending on the complexity or size of the operation, or on the degree of risk posed by the product being produced, without compromising the purposes for which training is proposed to be required. For example, could training for a small business with few hazards be accomplished in a shorter time and at a lower cost through the use of a video? FDA also invites comment on whether training in HACCP received before these proposed regulations become effective as final regulations should be ``grandfathered'' as fulfilling the training requirement. G. Sanitation Control Procedures 1. General FDA is proposing to require in Sec. 123.10 that processors and importers that engage in processing perform sanitation inspections at specified frequencies and maintain sanitation control records that document the results and frequency of those inspections. If these regulations are adopted, the sanitation control records will be subject to the recordkeeping requirements in Sec. 123.8, including review by FDA investigators. For seafood, sanitary practices affect most directly the safety of those products that do not receive any further cooking by the consumer. These products include raw molluscan shellfish; finfish destined to be consumed as sushi; cooked, ready-to-eat products; and certain smoked and salted products. Both finfish and shellfish are regarded as microbiologically sensitive foods based on the potential presence of pathogens, notably L. monocytogenes (Ref. 55, pp. 31 and 32). L. monocytogenes is a pathogenic bacterium that is widespread in the environment. Thus, the likelihood of finding it on the exterior surfaces and viscera of fish is high. Since 1983, several large outbreaks of human listeriosis have been linked to contaminated foods. Although it is a relatively rare illness, the exceptionally high mortality rate among susceptible individuals makes this illness one of the leading fatal foodborne diseases in the United States. Numerous seafood products have been shown to support growth of L. monocytogenes (Refs. 56 and 57), and seafoods have been epidemiologically linked to two outbreaks and one sporadic case of listeriosis (Ref. 58). Furthermore, several cooked seafood products have been recalled from the market in North America because of contamination with L. monocytogenes (Ref. 27). Seven of nine smoked fish processing facilities recently inspected by FDA in New York State had L. monocytogenes in the environment or in the products (Ref. 59). Good sanitation practices are critical to the prevention of listeriosis and other microbiologically related foodborne illnesses. FDA's CGMP regulations for food in part 110 set out general principles of sanitation that should be followed in plants that manufacture, package, label, or hold human food. They address such matters as personal hygiene and cleanliness among workers who handle food, the suitability of the plant design to sanitary operations, and the cleaning of food-contact surfaces. FDA inspections of seafood processors apply the principles in part 110. Nearly half of the consumer complaints relating to seafood that FDA receives in a typical year are related to plant or food hygiene (Ref. 60). The reasons, while not entirely clear, appear to be related to factors such as the age of processing facilities, the seasonal nature of operations that affect training, and the turnover of personnel. A representative cross section of those FDA establishment inspection reports (EIR's) for domestic seafood manufacturers that revealed CGMP deficiencies for fiscal years 1988-90 demonstrates this point (Ref. 61). The cross section involves 795 EIR's covering 561 facilities. (The number of EIR's exceeds the number of facilities because followup visits were made to check on the status of corrective actions.) The following percentages refer to EIR's with deficiencies where at least some of the deficiencies involved sanitation: (1) Twenty-three percent documented receiving area facilities that were not clean/orderly or in good repair. (2) Twenty-six percent documented facilities lacking effective insect and rodent control measures in the receiving area. (3) Sixteen percent documented failure to handle ice in a sanitary manner and to protect it properly. (4) Thirty-five percent documented lack of adequate cleaning or sanitizing of processing equipment. (5) Twenty-one percent documented processing equipment that was not constructed so that it could be easily cleaned and sanitized. (6) Eighteen percent documented processing equipment that was not made of suitable materials. (7) Fifteen percent documented hand sanitizers that were not kept at proper sanitizing levels. (8) Eighteen percent documented failure to have hand sanitizers available in the processing area. (9) Thirty percent documented processing areas that were not maintained in a clean and sanitary manner. (10) Forty-two percent documented processing areas with exterior openings that were not sealed/covered properly to prevent the entrance of pests or insects. (11) Sixteen percent documented waste material not being collected/ covered in suitable containers or not being disposed of properly. (12) Twenty-three percent documented handling of finished product in a manner that did not preclude contamination. (13) Twenty-two percent documented employees not taking necessary precautions to avoid food contamination. During fiscal years 1991-92, FDA conducted abbreviated inspections of nearly all domestic manufacturers in its seafood establishment inventory. These inspections provide data on sanitation practices and conditions that are generally consistent with the above findings (Ref. 62). Examples of these data are: (1) Sixteen percent of firms had problems with the general sanitation condition of their processing areas. (This percentage is lower than for item 9 above because the universe is all firms, not just firms with deficiencies.) (2) Nineteen percent of firms did not clean and sanitize their processing areas or equipment throughout the day's production. (This matches most closely with item 4 above but is lower, presumably for the reason stated in the previously numbered paragraph.) (3) Twenty-eight percent of firms had employees that were not following proper sanitation practices in processing activities. (This figure does not precisely match any of the items listed above because the EIR's break employee practices down into specific categories, such as the wearing of hair nets. Some categories involve relatively minor matters, others are more significant. Findings with respect to these employee practices were not listed above for the sake of brevity.) (4) Twenty percent had employees that were not following proper sanitation practices for packaging and finished product storage. (The parenthetical observations in the previously numbered paragraph apply here as well.) (5) Thirty-six percent of firms either lacked hand sanitizers in their processing areas or had sanitizers that were not kept at proper sanitizing levels. (This finding is equivalent to a combination of items 7 and 8 above. Surprisingly, this finding is roughly the same as 7 and 8 added together, even though it includes all processors rather than processors with deficiencies.) Sanitation problems found by NMFS during the operation of its fee- for-service inspection program for seafood manufacturers, as described earlier, are generally consistent with FDA's findings. Entrants into the NMFS program undergo initial sanitation surveys by NMFS and are checked for sanitation practices thereafter. NMFS' data show significant sanitation deficiencies during the initial surveys (Ref. 35, p. 40). Some of the most common for 1989 include: (1) Sixty-four percent of plants had discrepancies relating to proper cleaning and sanitizing of product contact surfaces or equipment, containers, or utensils after use. (2) Fifty-one percent of plants had discrepancies relating to design, materials, or construction that prevented their being maintained in a sanitary manner. (3) Forty-five percent of plants had discrepancies relating to design of equipment, containers, and utensils so that they did not provide protection from contaminants and could not be readily cleaned and effectively sanitized. (4) Forty-three percent of plants had discrepancies relating to improper storage of equipment, litter, waste, uncut weeds, and grass. (5) Forty percent had discrepancies relating to storage facilities that were not clean, sanitary, or in good repair. For established participants in the NMFS program (as opposed to entrants), the percentages with discrepancies in the above areas for 1989 were: 49 percent; 47 percent; 25 percent; 49 percent; and 33 percent (Ref. 35, p. 42). FDA has tentatively concluded on the basis of all of these findings that HACCP-type controls for sanitation as proposed below are needed. The sanitation measures required under proposed Sec. 123.10 are fundamental to good sanitation practices and can have a bearing on human safety. The agency recognizes, however, that depending on the conditions in a facility, additional measures may be necessary (see, e.g., part 110). FDA will expect processors to include those measures in their sanitation practices but tentatively concludes that it is not necessary to include them in the fundamental core of required steps. FDA acknowledges the conclusion of the MSSP project that, for seafood at least, it is possible to include sanitation within an HACCP system without unduly overburdening that system with large numbers of critical control points. The FDA/NOAA HACCP-based seafood pilot program included critical control points for sanitation. For these regulations, however, FDA has tentatively decided to propose specific HACCP-type requirements for sanitation, rather than require that processors identify critical control points for sanitation in their HACCP plans. The proposed requirements in Sec. 123.10 potentially relate to an entire facility, not just to a limited number of critical control points. FDA tentatively concludes that this step is necessary to fully implement section 402(a)(4) of the act and yet at the same time not overload the HACCP system. FDA invites comments on this approach. In particular, FDA invites comment on whether sanitation requirements should be enumerated as in proposed Sec. 123.10. The logical alternative would be to leave sanitation as one of the procedures that is to be identified and addressed in HACCP plans for the control of microbiological and physical hazards (see proposed Sec. 123.6(b)(1)(ii), (b)(1)(ix), and (b)(4)), but not to have specific provisions in the regulations as to how sanitation is to be achieved. Good sanitation blocks avenues for the introduction of pathogens, harmful chemicals, and physical objects and is an essential preventive control for safety. Even if a product is to be cooked by the consumer, the load of microbiological pathogens on that product when received by the consumer is still relevant to safety. FDA's prescriptive approach to sanitation in proposed Sec. 123.10 is intended to assist processors to provide the greatest protection for consumers. Nonetheless, FDA invites comment on whether an alternative approach as described above would ensure this protection at less cost. FDA is proposing in Sec. 123.10(a) to require that processors conduct sanitation inspections to ensure that the sanitation conditions in Sec. 123.10(a)(1) through (a)(17) are met. FDA recognizes that the nature of the operations conducted by a processor affects the hazards that may be presented by the product. Processing other than storing usually involves manipulation of exposed, i.e., unpackaged, fish and fishery products. Both the manipulation and the exposure subject the product to all the hazards that can occur from unsanitary practices. Storage, on the other hand, can subject the product to some, but nowhere near all, of the hazards associated with insanitation. Consequently, FDA is proposing to require that processors of fish and fishery products inspect for those conditions in Sec. 123.10(a)(1) through (a)(17) that are appropriate to their circumstances. FDA expects that, at a minimum, in, for example, storage facilities, such inspections will include ensuring against the presence of vermin, because this is a frequent problem in warehouses that can affect products even when they are being stored in a packaged state. In Sec. 123.10(a)(1), the agency is proposing to require that processors ensure that water that contacts the product or food-contact surfaces, or that is used in the manufacture of ice, is derived from a safe and sanitary source or is treated to render it of safe and sanitary quality. Water is used in virtually all fish and fishery product processing facilities for washing raw materials, product contact surfaces, and employees' hands. It is used to transport fish through the plant in water flumes. In addition, water is often an ingredient, as in soups and glazes. Contaminated water can serve as a vehicle for contamination of the product, both directly and indirectly (Refs. 63, 64; 65, p. 49; 66, 67, and 68, pp. 1 and 2). It can also serve as a vehicle for contamination as the ice in which the product is stored. The safety and sanitary quality of water from United States and some foreign public water systems is generally ensured through public water treatment, chlorination, or monitoring and control by local health authorities. Where this assurance exists, FDA does not anticipate that processors will need to implement any additional controls. Private sources of water, particularly surface waters or water from shallow wells, may be subject to microbiological, chemical, or radiological contamination attributable to the source itself or to surface contamination at the well head or intake. Private sources are also frequently untreated or minimally treated (Refs. 69, p. 15; and 70). Where the processor uses a private source of water, it will need to take steps to ensure that the water is of a safe and sanitary quality. These steps may include retaining a copy of the initial local health authority well design approval and copies of the local health authority fecal coliform test results; obtaining and maintaining copies of private coliform test results; performing and recording periodic inspections of the sanitary condition of the well head or source intake; and performing and monitoring appropriate water treatment procedures, including filtration, sedimentation, and chlorination. The type and frequency of controls exercised by the processor should be based upon the type of source water and its historic safety and sanitary quality. Consequently, the agency is proposing to require, in Sec. 123.10(c)(3), that such controls be performed and documented at such frequency as necessary to ensure control. In Sec. 123.10(a)(2), as a means of ensuring that potable water does not become contaminated, the agency is proposing to require that the processor ensure that there are no cross connections between the potable water system and any nonpotable systems. Nonpotable systems include waste water and sewage. Cross connections, which include situations that allow for back siphonage into a potable system from a nonpotable system under negative pressure conditions, can result in the chemical or microbiological contamination of the potable water system (Refs. 64; 65, pp. 50 and 51; 68, 71, and 72). For example, if a hose from a potable water system is left in a thawing tank with water and frozen fish, and if negative pressure occurs that draws water from the tank back through the hose to the potable water system, both the potable water line and the water source itself, i.e., the municipal or private water system, can become contaminated. Cross connections can best be controlled by performing periodic inspections of the potable and nonpotable systems. These inspections should be performed at least every time that there is a change in the plumbing of the systems and with sufficient additional frequency to ensure that unintentional cross connections do not develop. Consequently, in Sec. 123.10(c)(3), the agency is proposing to require that such inspections be performed and documented at such frequency as necessary to ensure control. FDA is proposing in Sec. 123.10(a)(3) to require that the processor ensure that all food-contact surfaces are designed, constructed, and maintained in a manner that minimizes the potential for chemical and microbiological contamination of the product. Utensils and equipment can be vehicles for microbial contamination of both the raw and finished products. Utensils, equipment, and other food-contact surfaces that are made of corrosive material or wood, or that contain breaks, pits, cuts, or grooves, may harbor pathogenic microorganisms that can migrate to the product and contaminate it. These kinds of surfaces are difficult to clean, with the pores and crevices shielding the microorganisms from the action of cleaning and sanitizing agents (Refs. 65, pp. 20, 36-48; 72, pp. 166 and 167; and 73). Additionally, where food-contact surfaces are constructed of toxic materials (e.g., lead shucking blocks), the product may be directly contaminated with the toxic material (Ref. 74). Therefore, FDA tentatively concludes that it is necessary to require that processors take affirmative steps to minimize the possibility that any risks will be created by the utensils and equipment they use. Proper construction of the equipment should be ensured at the time it is received, and whenever it is modified or repaired. The frequency of subsequent inspections necessary to ensure that the sanitary condition of the equipment has not declined with time will depend on the frequency of its use, the materials and construction methods, and the nature of its use. In Sec. 123.10(c)(3) the agency is proposing to require that such controls be performed and documented with such frequency as is necessary to ensure control. In Sec. 123.10(a)(4), the agency is proposing to require that the processor ensure that food-contact surfaces are regularly cleaned and sanitized with cleaning and sanitizing preparations that are suitable for this purpose. Surfaces that are not adequately cleaned and sanitized can be a source of filth to subsequent products produced on the equipment, an attractant for vermin, and a reservoir for pathogenic microorganisms. Infrequent cleaning of equipment can result in the formation of biofilms, microscopic films in which microorganisms can be entrapped, shielded from the action of sanitizers, and physically bound to the food-contact surface of the equipment. An effective cleaning compound is one that will lower the surface tension of water so that spills can be lifted and flushed away. Ordinary soap is generally ineffective for equipment washing because of its limited ability to solubilize fats, oils, and proteins. Mildly alkaline detergents are generally suitable for cleaning seafood processing plants, but high alkaline detergents are often necessary for heavy buildups of fats and proteins. Mineral deposits will frequently require the use of acid cleaners. An effective sanitizing agent is one that has a good bacteriocidal effect on the types of pathogens normally present in the plant environment and is safe, stable, and convenient for use. Examples include hypochlorites, iodophors, and quaternary ammonium compounds (Refs. 73, 74, 75, 76, and 77). To eliminate the product residue that accumulates on product contact surfaces during production, FDA is proposing in Sec. 123.10(a)(4)(i) to require that utensils and surfaces of equipment that contact food during processing be thoroughly washed at the end of the day's operations. FDA is also proposing in Sec. 123.10(a)(4)(iii) that sanitizing be performed on the same utensils and equipment immediately before the beginning of production, so that any recontamination that occurs between cleaning and production can be eliminated. FDA is proposing to require in Sec. 123.10(a)(4)(ii) that, in those operations in which microbiological contamination can adversely affect the safety of the product (e.g., the processing of cooked, ready-to-eat products), the equipment also be washed and sanitized at least every 4 hours during processing. Washing and sanitizing with this frequency is necessary to inactivate mesophilic pathogens, such as Salmonella spp., before they leave the lag phase of growth and enter the rapid log phase (Ref. 23). Temperatures in fish and fishery product processing plants are generally not low enough to control the growth of such microorganisms and are certainly not low enough to control the growth of such psychrotropic pathogens as L. monocytogenes (Refs. 23, 78, 79, and 80). Therefore, FDA tentatively finds that washing and sanitizing equipment every 4 hours is necessary. FDA is proposing to require both cleaning and sanitizing because neither step is fully effective without the other. When sanitizing occurs without benefit of cleaning, pathogenic microorganisms can be protected from the action of the sanitizer by food residue. Conversely, while cleaning can effectively remove product residue and a portion of the microorganisms, sanitizing is generally needed to remove the remaining microorganisms (Refs. 81 and 82). FDA is proposing to require in Sec. 123.10(c)(2) that the processor inspect the condition of the utensils and surfaces of equipment that contact food immediately after each cleaning and sanitizing. The purpose of the inspection is to ensure the adequacy of the cleaning and sanitizing operations, and to ensure that the equipment is in a condition that is suitable for further operations. The agency is also proposing in Sec. 123.10(c)(2) that the processor document the time of each cleaning and sanitizing, the concentration of the sanitizer, and the condition of the equipment. Documentation of the time of each cleaning and sanitizing will facilitate an assessment of compliance with the frequency requirement of Sec. 123.10(a)(4). Documentation of the concentration of the sanitizer will facilitate an assessment of the adequacy of the sanitizing operation. Sanitizers must be of sufficient strength to be effective, while excessive sanitizer concentrations can contaminate the product with indirect food additives (21 CFR part 178) (Ref. 82). Documentation of the condition of the equipment is necessary to ensure that it is examined after cleaning and sanitizing to make sure that these processes were done properly. The agency is proposing in Sec. 123.10(a)(5) to require that the processor ensure that gloves and outer garments that contact the food or food-contact surfaces are made of an impermeable material and are maintained in a clean and sanitary condition. Gloves or aprons that are made of cloth or other porous materials are difficult to clean and may serve as a reservoir for pathogenic microorganisms that can migrate to the food during processing, in much the same manner as previously described for processing equipment (Refs. 65 and 83). Gloves and aprons that are not maintained in a clean and sanitary condition can also house pathogens that can migrate to the food. Therefore, FDA tentatively finds that it is appropriate to require the measures set out in Sec. 123.10(a)(5). At Sec. 123.10(c), the agency is proposing to require that, like most of the other sanitation measures that FDA is proposing, the sanitary condition and impermeability of gloves and outer garments that may contact the food or food-contact surfaces be checked at least daily while processing operations are occurring. Such checking will ensure that employees arriving for work are equipped with gloves and outer garments that will not serve as a source of contamination to the product. It will also ensure that employees are never using personally owned gloves and garments that are made of materials that are unsuitable for the processing environment. Proposed Sec. 123.10(c) also requires that such checking be documented on a daily basis to provide a record that such checking has occurred. Under proposed Sec. 123.10(a)(6), the processor must ensure that employees' hands, gloves, outer garments, utensils, and food-contact surfaces that come into contact with insanitary objects are thoroughly cleaned and sanitized before contacting fish or fishery products. Under proposed Sec. 123.10(a)(7), the processor must also ensure that employees' hands, gloves, outer garments, utensils, and food-contact surfaces that contact raw products are thoroughly cleaned and sanitized before they contact cooked product. Employees and food-contact surfaces can serve as vectors in the transmission of filth and pathogenic microorganisms to the food. Filth and pathogenic microorganisms can be brought into the processing environment on the employees' hands from outside areas, restrooms, contaminated raw materials, waste or waste receptacles, floors, and other insanitary objects (Refs. 63, 64, 73, 74, 84, and 85). Bacteria naturally present on fresh fish skin and gills and in the gastrointestinal tract reflect the microbial content of the water from which the fish were harvested. Typical microorganisms found on and in fresh fish include C. botulinum, enteric bacteria, Vibrio parahaemolyticus, salmonella, shigella, hepatitis A, and other microorganisms that pollute harvest waters (Ref. 7). These microorganisms contaminate the environment in processing plants and cannot, using reasonable methods, be completely eliminated. Proper precautions, such as proper hand and equipment cleaning and sanitizing, must be taken to minimize opportunities for contamination of the finished product (Refs. 63, 64, 73, 74, and 84). Therefore, FDA is proposing in Sec. 123.10 (a)(6) and (a)(7) that such precautions be taken with respect to hands, gloves, garments, utensils, and food- contact surfaces. The agency recognizes that not all processing activities will require hand washing and sanitizing. Activities that would not require such steps include the handling of raw fish and fishery products prior to the initial washing step (i.e., directly from the fisherman) and the handling of finished products in shipping cases. These activities are exceptions, however, to the general rule that employees must thoroughly wash and sanitize their hands after each contact with an insanitary surface. Additionally, when insanitary objects come into contact with product contact surfaces, they must be thoroughly cleaned and sanitized. In the processing of cooked products, the raw material may also serve as a reservoir of pathogenic microorganisms. For this reason, employees or equipment that handle or touch the raw material must be cleaned and sanitized before being used with cooked product or ice, or they could convey the microorganisms to these foods (Refs. 63, 64, 73, 74, 84, 87, and 88). In Sec. 123.10(c)(1), the agency is proposing to require that the sanitary practices of the employees, especially as they relate to hand washing, sanitizing practices, and the potential for cross contamination, be checked and recorded at least every 4 hours during processing. This monitoring will ensure that employees arriving for work and returning from the midshift break have properly washed and sanitized their hands. The concentration of hand sanitizing solutions tends to be reduced over the course of a production day because of the reaction of the sanitizer with organic matter and dissipation as a gas (Ref. 82). It will also cause a regular assessment of the adequacy of the normal operating procedures. Finally, recording will provide assurance that appropriate procedures are being followed. In Sec. 123.10(a)(8)(i), FDA is proposing to require that hand washing facilities be located in all processing areas in which washing and sanitizing is required by CGMP's so that these facilities are readily accessible to employees who work in processing areas. The agency has tentatively concluded that proper sanitization is such an important part of preventing the spread of disease as to warrant a requirement that hand washing equipment be conveniently located to facilitate their use. Where these facilities are not conveniently located, they may not be frequented by the employees. FDA is proposing to require in Sec. 123.10(a)(8)(ii) that these facilities be equipped with hand cleaning and effective sanitizing preparations and single-service towels or suitable hand drying devices. Ordinary soap is acceptable for hand washing. Hand sanitizers need to be fast acting because of the short contact time involved. In contrast to the sanitizing of equipment, which can involve leaving a sanitizing spray on the equipment for extended periods of time, hand sanitizing usually involves a quick dip in and out of the sanitizer. Of the sanitizers described previously (see discussion of proposed Sec. 123.10(a)(4)), quaternary ammonium is not fast acting and is not suitable as a hand sanitizer. The others are appropriate as hand sanitizers. The agency is proposing to require single-service towels or suitable hand drying devices to ensure that microbiological contamination does not occur though the repeated use of the same towel by several individuals. A hot-air blower is an example of a suitable hand drying device because contamination from individual to individual is eliminated. In Sec. 123.10(c)(3), the agency is proposing to require that inspection and documentation of the location of hand washing facilities be performed at sufficient frequency to ensure that there is compliance with Sec. 123.10(a)(8)(i). Generally, this procedure will be necessary only after construction or any significant building or process modification. FDA is proposing to require in Sec. 123.10(c) that the processor inspect, and document that it has inspected, the hand washing and hand sanitizing facilities to ensure that they are properly equipped no less than once per day. This procedure will ensure that cleaning and sanitizing preparations, as well as towels or hand drying devices, are present whenever needed by employees. FDA is proposing to require at Sec. 123.10 (a)(9) and (a)(10) that the processor protect the food, food-contact surfaces, and food packaging materials against adulteration by chemical and physical contaminants. Such protection is necessary to ensure that the food produced by the processor is safe. The use of toxic compounds (e.g., pesticides, cleaning and sanitizing agents, and lubricants) is frequently necessary in the processing environment. For example, lubricants and fuel are necessary to operate equipment. Improper use of these compounds is a frequent cause of product adulteration throughout the food industry (Ref. 74). Thus, it is necessary to ensure that food, food-contact surfaces, and food packaging materials are not contaminated by these toxic compounds. Food and food packaging material should be protected or removed from areas where pesticides are used, and caustic cleaning compounds should be thoroughly removed from food- contact surfaces before processing begins. Finally, as an additional protection, FDA is proposing to require in Sec. 123.10(a)(10) that toxic compounds be labeled, held, and used in a manner that minimizes the risk of contamination of the product. FDA is proposing to require in Sec. 123.10(c) that the processing plant be inspected daily to ensure that the food is protected from toxic compounds, and that this inspection be documented. This check should normally be performed before the start of operations, at a time when the equipment can be effectively inspected, and in time to prevent adulteration of the product. Because processing conditions vary on a day-to-day basis, FDA has tentatively concluded that daily inspection is necessary. FDA is proposing to require at Sec. 123.10(a)(11) that the processor ensure that products are not exposed to contaminants that may drip, drain, or be drawn into the food. An example of such a contaminant is condensate, which may form on the ceilings and equipment in a processing plant. If the condensate forms on an insanitary surface and then falls on the product, it may carry with it filth and microbiological contaminants from that surface to the food (Ref. 65, pp. 24 and 25). In Sec. 123.10(c), the agency is proposing to require that the processing plant be inspected daily to ensure that the potential for such contamination is minimized, and that this inspection be documented. This check should normally be performed during the actual operations, at a time when condensate or other such contaminating conditions are likely to be present. As explained above, the agency has tentatively concluded that daily variations in processing and climatic conditions necessitate daily inspection. In Sec. 123.10(a)(12), the agency is proposing to require that the processor ensure that compressed gases that contact food or food- contact surfaces of equipment are filtered or treated in such a way that the food is not contaminated with unapproved indirect food additives or other chemical, physical, or microbiological contaminants. Compressed gases can be contaminated with oil from the compressor, filth and microbiological contaminants from the air intake, and rust or other physical contaminants from the compression, storage, and distribution equipment. Filtration at the air intake and after compression, storage, and distribution is an effective means of reducing the risk of such contaminants entering the food (Ref. 89). FDA is proposing to require in Sec. 123.10(c)(3) that the filtration and other equipment used to protect the food from such contaminants be inspected, and the inspection documented, with such frequency as is necessary to ensure control. Normally, this frequency will be directed by the manufacturer of the filtration equipment. FDA is not proposing to require daily inspection because the filter and related equipment do not normally need cleaning or replacement on a daily basis. FDA is proposing to require in Sec. 123.10(a)(13) that the processor take action to ensure that unprotected cooked, ready-to-eat fishery products, smoked fishery products, raw molluscan shellfish, and raw fish and fishery products are physically separated from each other during refrigerated storage. Cooked, ready-to-eat products are products that will not normally receive a cooking by the consumer adequate enough to kill pathogens. Therefore, any microbiological recontamination of the product after cooking can subject the consumer to health risks. Raw molluscan shellfish may contain pathogens that can cause severe illness to certain at-risk individuals, e.g., those who are immunocompromised. These individuals might know to avoid eating raw molluscan shellfish but would not expect the same health risk from cooked, ready-to-eat products. Similarly, raw fish and fishery products may contain filth and pathogenic microorganisms not normally associated with raw molluscan shellfish or cooked, ready-to-eat products (Refs. 63 and 84). In Sec. 123.10(c), the agency is proposing to require that refrigerated storage areas be inspected at least daily to ensure that the three types of products are physically separated from each other. This check should normally be performed during actual operations, at a time when commingling of these products is likely to take place. The agency has tentatively concluded that daily inspection is necessary because products are normally moved in and out of refrigerated storage areas on a regular basis, creating an ongoing threat that problems will occur. FDA is proposing to require in Sec. 123.10(a)(14) that refrigerated storage units operate at 40 deg.F (4.4 deg.C) or below when storing raw materials, in-process or finished cooked, ready-to-eat fishery products, smoked fishery products, and fish and fishery products made in whole or in part of scombroid toxin forming species. The purpose of this requirement is to ensure that processors control microbiological hazards associated with refrigerated storage for these products (Refs. 85 and 86). Cooked, ready-to-eat products as defined in proposed Sec. 123.3(b) and smoked fishery products (see Appendix 1) are not shelf-stable and must be kept refrigerated to retard the growth of microorganisms. As stated above, these products will not normally be cooked by the consumer at a sufficient temperature to destroy any pathogens that may be present. Scombroid toxin forming species are addressed in considerable detail later in this document. These species can form a toxin harmful to humans if subjected to time/temperature abuse after capture. Proper refrigeration is essential for fish and fishery products that include these species. Maintaining product temperatures during storage in a range that will minimize the growth of mesophilic and psychrotropic pathogens is necessary to ensure product safety throughout the shelf life of these products (Ref. 85). It is uniformly more convenient to control refrigeration unit temperatures than to control and monitor the internal temperatures of the various products under refrigerated storage, particularly when these products are in sealed containers. For these reasons, FDA is proposing that refrigeration units be operated at or below 40 deg.F (4.4 deg.C). FDA tentatively finds that this temperature is appropriate because it is adequate to minimize the growth of pathogens (Refs. 85 and 86.) The agency also strongly recommends this temperature or lower for all fish and fishery products that need refrigeration, regardless of whether safety is an issue. The agency is also especially interested in obtaining comment on the appropriateness of this temperature. In Sec. 123.10(c)(4) the agency is proposing to require that the processor use instruments that monitor the temperature of refrigeration units on a continuous basis. The measurements from those instruments must be checked and documented with such frequency as is necessary to ensure control. Continuous monitoring ensures that temperature fluctuations above 40 deg.F (4.4 deg.C), if any, as a result of circumstances such as heavy cooler loading, frequent cooler entry, or power failures, are quickly detected. The guideline for cooked, ready-to-eat products, in Appendix A, section 6, describes alternative ways to continuously monitor the temperature. A temperature-recording device can show both the high temperature and the length of time that refrigeration unit was operating at that temperature. Maximum-indicating thermometers and high temperature alarms also show that the critical limit has been exceeded but cannot show the duration of the deviation. Consequently, when a maximum-indicating thermometer or high temperature alarm reveals a deviation, the processor will need to assume loss of control since the last time that the measurements displayed by the instruments were checked, unless reasonable evidence exists to the contrary. The more frequent such checks are made, the lower the risk to which the processor is exposed. During periods when the refrigeration unit is not frequently entered and the load is constant, such as overnight, it is reasonable to reduce the frequency. However, during periods of heavy use and frequent entry, the frequency should be increased. FDA is proposing to require in Sec. 123.10(a)(15) that the processor ensure that persons with sores or illnesses that present an increased risk for product contamination are excluded from those areas of processing where such contamination is likely. Employees can serve as a reservoir of foodborne diseases, such as salmonellosis, shigellosis, and hepatitis, that can be passed on to the consumer through the fecal-oral route. Additionally, open sores, boils, or infected wounds present the potential for contamination of the food with such pathogenic microorganisms as Staphylococcus aureus. Employees with suspicious illnesses or sores can be effectively screened upon arrival at the processing facility with minimal personal intrusion (Refs. 22, 74, and 84). In Sec. 123.10(c), the agency is proposing to require that such screening, and documentation of the screening, take place daily. This frequency will ensure that changing health conditions of the employees are not missed. In Sec. 123.10(a)(16), the agency is proposing to require that the processor ensure that toilet facilities are available and maintained in a sanitary condition and in good repair, and that these facilities provide for proper disposal of the sewage. Toilet facilities eliminate from the processing environment pathogenic microorganisms shed in fecal material. Where fecal material is not properly conveyed from the processing plant to an acceptable treatment facility, restroom floors and grounds around the processing facility can become contaminated with pathogens. Foot traffic over the affected areas can introduce pathogens to the processing room and cause product contamination. Insanitary toilet facilities can also increase the potential for contamination of employees' hands and, ultimately, the product (Refs. 64 and 74). FDA is proposing to require at Sec. 123.10(c) that the toilet facilities be inspected, and the inspection be documented, to ensure that they function properly and are in a sanitary condition at least every day. Ordinarily this inspection should be performed before each day's operation to ensure that the facility is ready at the beginning of the day. In Sec. 123.10(a)(17), the agency is proposing to require that the processor ensure that no pests are present in the processing area. Pests, such as rodents, birds, and insects carry a variety of human disease agents, which they can introduce to the processing environment (Refs. 63, 64, 73, and 84). Additionally, their feces constitutes filth which can contaminate the food. A daily inspection of the processing facility, as proposed in Sec. 123.10(c), serves to assess the effectiveness of the processor's pest control activities and redirect them where necessary. In Sec. 123.10(a)(18), the agency is proposing to require that the processor ensure that the plant is designed to minimize risk of contamination of the food. Proper construction is essential if the other sanitary measures that FDA is proposing to require are to be successful. It includes the isolation of incompatible operations, such as the handling of raw materials and the processing of cooked products (Refs. 71, 74, 87, and 88). A periodic inspection of the facility for structural defects, product flow, and general building condition is necessary to ensure that these attributes do not pose an increased potential for product contamination. In Sec. 123.10(c)(3), the agency is proposing to require that such controls be performed and documented with sufficient frequency to ensure control. FDA is proposing to require at Sec. 123.10(b) that processors maintain sanitation control records that document the occurrence and findings of the inspections required by Sec. 123.10(a) as well as the frequency required by Sec. 123.10(c). FDA is also proposing to require that the problems found during these inspections be corrected, and the corrections recorded in accordance with proposed Sec. 123.10(d). Such corrections are essential to the proper working of the HACCP system. The records that are produced are subject to the recordkeeping requirements of proposed Sec. 123.8, including being subject to inspection by FDA investigators. FDA has tentatively concluded that HACCP-type preventive controls, including recordkeeping, will ensure that the hazards caused by insanitation are controlled by design. Recordkeeping is the key to an HACCP-type system. The agency's access to these records is essential to ensuring that the system is working. In addition to these proposed requirements, FDA is encouraging processors in Sec. 123.10(e) to have a written standard operating procedure for sanitation. The details of many sanitation procedures can differ from plant to plant depending upon the type of operation and other conditions. For example, how a piece of equipment should be cleaned can differ from plant to plant. In one plant, it may be necessary to disassemble all or part of the equipment in order to clean it. In other plants, breaking down the equipment may not be necessary. Likewise, different cleaning compounds may be needed from one plant to another in order to solve specialized problems such as buildups of mineral deposits. FDA is therefore encouraging each processor to study its own plant and develop a procedure that is tailored to that processor's needs and circumstances. 2. Evisceration of Raw Fish In 1988, following botulism outbreaks traced to consumption of kapchunka, FDA published compliance policy guide (CPG) 7108.17 for salt-cured, air-dried, uneviscerated fish (53 FR 44949 November 7, 1988). In this CPG, FDA stated that the processing and sale of smoked and salted uneviscerated fish products pose a potential health hazard, and that it would consider such products to be adulterated under section 402(a)(4) of the act in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health (Ref. 175). FDA issued this CPG in an effort to prevent further outbreaks, as well as other potential health hazards, related to the consumption of ungutted fish products. The agency recognized only two exceptions: (1) Small species, such as anchovies and herring pieces (sprats), provided that they are processed by a method that will ensure a water-phase salt content of at least 10 percent, a water activity below 0.85, or a pH of 4.6 or less; and (2) fish that are fully cooked before further processing. As previously noted, C. botulinum, as well as other microorganisms, are naturally present in the intestinal tract of both fresh-water fish and marine fish. Therefore, it is essential not only to remove the viscera but to do so in a manner that does not contaminate the fish flesh with viscera contents. It is the viscera that can contain the majority of the hazardous microorganisms (e.g., C. botulinum and L. monocytogenes) that pose the potential health hazard (Refs. 165 through 167). After the viscera is removed, it must be discarded immediately to a segregated area, using a method that minimizes the potential for contamination or cross-contamination of utensils, equipment, raw materials, and other processed products. Uneviscerated fish that have been smoked, smoke-flavored, or salted, and that are intended to be filleted after processing, pose the same potential health hazard as those products sold as uneviscerated whole fish. The potential health hazard is created when the viscera is removed after processing. As the fish are being filleted, the viscera may be cut, and its contents may spill out, contaminating the processed fish. As a result, the opportunity arises for C. botulinum spore outgrowth and toxin production as well as for growth of other food spoilage microorganisms in these types of products. Therefore, the agency is proposing to require in Sec. 123.10(f) that, subject to the same limitations that were set forth in the CPG: (1) All fish for smoking or salting be eviscerated prior to processing, and (2) the process of evisceration must be performed in an area that is segregated and separate from other processing operations. H. Imported Seafood As stated earlier, imports make up over half of the seafood consumed in this country, in sharp contrast to meat and poultry, which are primarily domestically produced. Many of the hazards that can affect imported seafood are likely to occur before it enters the United States. These hazards include those that can be acquired from the environment before harvest and those that are process-induced. Detection of these hazards is the focus of the current regulatory system, and thus FDA tries to ensure safety by testing imported product. However, product testing places a substantial burden on the agency. The system currently is overburdened because of limits on the number of government personnel available to collect and analyze samples of imported product. In addition, FDA is concerned because this system does not promote industry responsibility and accountability the way an HACCP-based problem prevention system would. Given when most problems with imported seafood occur, these problems can be more efficiently controlled if the seafood is subject to HACCP controls before it is offered for import into this country than if the product is simply tested at the time that it is offered for sale. Therefore, FDA has tentatively concluded that these HACCP regulations should cover imported products in the same manner, to the extent possible, that they cover domestic products. Accordingly, FDA is proposing to make importers subject to the general provisions of subpart A. Thus, FDA is proposing in Sec. 123.11(a) to require that products that are offered for import be produced under the same HACCP and sanitation controls that it is proposing to apply to domestically produced seafood. FDA is proposing to require that importers adopt an HACCP plan that includes the criteria for how they will decide to purchase and then handle seafood while it is under their control. They must also establish ways to determine that these requirements are being met. More specifically, the plan must include hazard analysis, critical control points, and critical limits for each type of product imported as well as a copy of each supplier's HACCP plan for those products, as required in Sec. 123.11(b). Under proposed Sec. 123.11(b), these plans must be available on file at the importer's U.S. place of business. As stated above, the agency is developing a hazard analysis book to assist importers, as well as processors, in designing their individual plans. Because of the proposed requirement of Sec. 123.11(b) that importers must have on file an HACCP plan from each of their foreign suppliers, foreign processors who wish to offer their products for import into the United States after the implementation of this regulation will have to operate under valid HACCP plans and sanitation control procedures and furnish copies of those plans to the U.S. importers. The foreign processors should maintain appropriate monitoring records, as dictated by the principles of HACCP already discussed. These records should be kept at the foreign processors' places of business. Importers will be required under proposed Sec. 123.11(c) to take affirmative steps to monitor that their suppliers are in fact operating under their HACCP plans. Thus, under this proposal, the importer will need to take such steps as: (1) Obtaining records from the foreign processors' facilities; (2) obtaining certification from foreign governments that the suppliers are operating under valid HACCP plans or obtain certification lot by lot; (3) visiting the facilities to inspect them on a regular basis; or (4) taking some similar type of action, e.g., end product testing. For example, importers of swordfish may specify to their suppliers that the mercury level in the swordfish that they purchase cannot exceed FDA's action level of 1 part per million methyl mercury. The importers may decide to require certificates of analysis for methyl mercury on a regular basis from their suppliers as a means of ensuring that the swordfish that they offer for import into the United States is not adulterated. Section 123.11(d) provides an option for those importing from a country that has an active memorandum of understanding (MOU) or similar agreement with FDA. If the MOU is current, and if there is equivalency between the inspection system of the foreign country and the U.S. system, the importer will be able to rely on the MOU in lieu of the actions required under Sec. 123.11(c). An active MOU must accurately reflect the current situation between the signing parties and be functioning and enforceable in its entirety. It is the importer's responsibility to determine whether the MOU is in fact active, and whether it covers the products that the importer intends to receive from that country. Finally, the agency strongly encourages importers (as reflected in proposed Sec. 123.11(e)) to require their suppliers to obtain HACCP training such as is required in Sec. 123.9. Proposed Sec. 123.12 provides that there must be evidence that seafood offered for import has been produced in accordance with part 123, subpart A. As stated previously, FDA is including this requirement to ensure that there is equivalent treatment of imported and domestic products. FDA can ensure that domestic product is being produced in accordance with the HACCP plan and the sanitation controls in Sec. 123.10 through direct observation and review of records. Similar inspection of foreign processors would be prohibitively expensive. However, FDA tentatively finds that mere reliance on the existence of an HACCP plan is not enough, and that additional evidence of compliance must be provided. FDA tentatively finds that this evidence can be provided by the means listed in proposed Sec. 123.12(a). One of the ways that the agency contemplates obtaining this evidence would be by inspecting, at the importers' U.S. place of business, the importers' and foreign suppliers' HACCP plans, sanitation procedures, and records associated with the importers' plans. If these records demonstrate that the foreign processor and the importer are operating in accordance with adequate HACCP plans, agency will have assurance that the food is not adulterated under section 402(a)(4) of the act. FDA also intends to pursue MOU's with countries that demonstrate that their inspection systems are and continue to be substantially equivalent to those in the United States (proposed Sec. 123.12(a)(2)). The existence of an active MOU between FDA and the country of origin covering the seafood products being offered for import will provide assurance that these products covered by the MOU are being produced under appropriate conditions. If there is no MOU, the agency will take into consideration, for purposes of verifying the compliance of imported seafood, knowledge that a foreign country has an advanced seafood inspection system that provides for plans that are HACCP based, as provided in proposed Sec. 123.12(a)(3). The existence of such a regulatory system and its enforcement will provide assurance about the conditions under which products exported from that country are being produced. Proposed Sec. 123.12(a)(4) provides that inspection of foreign processors by the agency or other organization designated by FDA may also be used to establish compliance with these regulations. Finally, the agency intends to use other measures as it finds appropriate to make determinations about the acceptability of the product being offered for import, including but not limited to end product testing, as in proposed Sec. 123.12(a)(5). If assurances do not exist, as described in Sec. 123.12(a), that the product has been produced under an HACCP plan and under sanitation controls that are equivalent to those required of domestic processors, the agency will deny entry to the products as provided in proposed Sec. 123.12(b) because the product will appear to be adulterated (see section 801(a) of the act). I. Raw Molluscan Shellfish FDA is proposing to require in part 123, subpart C that processors of raw molluscan shellfish include in their HACCP plans how they control the origin of the molluscan shellfish that they process. Proposed Sec. 123.28 requires that these controls include obtaining raw shellfish only from approved growing waters through harvesters or processors licensed by a shellfish control authority. FDA is proposing to require that processors maintain records to document that each lot of raw molluscan shellfish meets these requirements. Under this proposal, these records will constitute HACCP records subject to the requirements of proposed Sec. 123.8. The agency is also proposing to establish a system of tagging or other labeling that provides information about the origin of all shellstock and shucked molluscan shellfish received by a processor. FDA is proposing to amend Sec. 1240.60 (21 CFR 1240.60) to provide for such a tagging system. Raw molluscan shellfish are molluscan shellfish that have not been subject to a treatment sufficient to kill pathogens of public health significance. Shellfish that have been subjected to any form of treatment, such as steam, hot water, or dry heat, for a short period of time before shucking to facilitate removal of the meat from the shell are still considered to be raw. Molluscan shellfish consumed raw or partially cooked pose unique public health risks. They probably cause the majority of all seafood- related illnesses in the United States (Refs. 6; and 7, p. 330). The safety of raw molluscan shellfish directly reflects the cleanliness of its aquatic environment. Of all edible species of fish, molluscan shellfish are unique in that they are nonmotile, filter feeding organisms. They pump large quantities of water through their bodies during the normal feeding process (Refs. 7, p. 331; and 90, p. c-4). The positive relationship between harvesting areas contaminated by sewage pollution and shellfish-borne enteric disease has been demonstrated many times (Refs. 7, p. 76; 91 and 92). During feeding, the shellfish may concentrate pathogenic microorganisms, deadly toxins associated with naturally occurring marine plankton (Ref. 93), or forms of agricultural and industrial pollution (Ref. 94). Among the pathogenic microorganisms is the Norwalk virus, probably the most common cause of seafood-borne illness. This virus commonly occurs in waters contaminated by sewage effluent (Refs. 7, p. 76; 91, 92, and 95). Before the adoption of the current public health controls in the United States, shellfish commonly transmitted many serious communicable diseases. Consumption of raw or undercooked seafood from polluted waters can be a mode of transmission for typhoid fever, infectious hepatitis, and cholera (Ref. 67). These diseases are still commonly associated with raw shellfish consumption in lesser developed countries (Ref. 7, p. 73). However, the incidence of these diseases in the United States has been largely controlled under section 361 of the PHS Act (42 U.S.C. 264). This statute was enacted to prevent the introduction, transmission, and spread of communicable disease. Under provisions of the PHS Act, FDA is empowered to accept assistance from the States to protect public health. Accordingly, FDA participates in a Federal/State cooperative program called NSSP. Established in 1925, the NSSP provides water quality criteria for assessing the safety of shellfish growing areas. These criteria are applied by the States under the authority of their own laws. The NSSP ``Manual of Operations'' provides the basis (Refs. 90 and 96) for State regulation in 23 shellfish-producing States and 6 nations. Each participating State or nation classifies and monitors its shellfish growing waters, controls harvesting, inspects shellfish packing and shucking facilities, and issues certificates to individual shellfish processors that meet the State or foreign government's shellfish control criteria. To assist themselves in the implementation of their shellfish laws, the States have formed the ISSC. The ISSC is an organization of State officials, representatives of Federal agencies, and representatives of the shellfish industry. It provides guidance to the States and provides a forum for them to discuss their problems in attempting to ensure the sanitary control of shellfish handling and production (Ref. 97, p. 3). FDA evaluates State and international shellfish sanitation programs (Ref. 98, part I, p. 2). When it finds that the program is consistent with the NSSP, FDA accepts the State's or country's shipper certifications. FDA publishes the ``Interstate Certified Shellfish Shippers List'' monthly, in which it lists the approximately 2,000 shellfish dealers that have been certified by participating States. While FDA continues to believe in the cooperative partnership that it has established with the States, there is evidence that this system is not protecting the public health as well as it might (Refs. 7, p. 331; 99, p. iii; and 100). Problems can originate anywhere. As explained in the discussion above of the term ``lot of molluscan shellfish,'' the water from which shellfish are harvested plays a significant role in determining their safety. If they are harvested from unclassified or polluted waters, shellfish can be a vector of communicable disease. Problems can also occur as a result of conditions under which the shellfish are held on the harvest vessel, in the processing plant, or by subsequent handlers or repackers of shucked products. Given the current situation, FDA has tentatively determined that it is necessary for it to take steps to strengthen and provide additional support for the existing cooperative program. Thus, FDA is proposing two measures. First, FDA is proposing to add Sec. 1240.60(b), which will require that all shellfish offered for transport or transported in interstate commerce bear a tag that lists the date, place, type, and quantity of shellfish, and by whom it was harvested, including the harvester's identification number. FDA is proposing this requirement because it has determined that a tag is the only means by which the agency can ensure that it will be possible to determine whether the shellfish have been taken from safe water. FDA is proposing to require that the place where the shellfish were harvested be listed because it will enable a processor who receives the shellfish, or a regulatory official who inspects them, to determine whether they were taken from safe water. FDA is proposing to require that the date when the shellfish were harvested be listed because, as discussed above, the shifting conditions in shellfish harvesting waters make shellfish safety virtually a day-to-day proposition. Therefore, when the shellfish are harvested becomes a critical factor. FDA is proposing that the type of shellfish e.g., oysters, clams, mussels, or scallops, and quantity be shown on the tag or bill of lading to ensure that the tag is applied only to the product to which it was initially affixed. Information on type and quantity of shellfish describes that product. FDA is proposing to require that the person by whom the shellfish were harvested be listed because that person has the most direct knowledge of where and when the shellfish were harvested and should be readily identifiable in case there are problems with the shellfish, so that quick action can be taken to meet the effect of any problem. Finally, FDA is proposing that the harvester identification number issued by the shellfish control authority be included to provide a means to confirm the harvester's identity and to obtain the harvester's local address in case of an illness investigation or followup to tagging and labeling discrepancies. FDA is proposing this tagging requirement under section 361 of the PHS Act. Under this section, the Surgeon General and, by delegation, FDA, is authorized to make and enforce such regulations as in FDA's judgment are necessary to prevent the introduction, transmission, or spread of communicable disease. FDA tentatively finds that requiring a tag is a measure necessary to prevent the spread of communicable diseases because the tag will readily permit identification of those raw shellfish that were harvested from properly classified waters, and thus that will not be vectors of communicable disease in interstate commerce, and those that were not harvested from properly classified waters and thus that may be vectors of disease. Under the PHS Act, FDA is also authorized to provide for such measures which in its judgment may be necessary to enforce the regulations that it adopts to prevent the spread of communicable diseases (section 361(a) of the PHS Act). Therefore, FDA is proposing to provide in Sec. 1240.60(b) for the seizure and destruction of any shellfish that are not properly tagged. Without the assurances provided by the tag, the shellfish may bear a microorganism that may render them injurious to health. Thus, they are unfit for consumption and must be removed from the food supply. FDA recognizes that all shellfish-producing States have laws that require the tagging of shellfish. This proposal is intended to support those laws, not supersede them. The proposed tagging requirement is necessary for two reasons. First, there is no assurance that untagged shellfish come from safe waters. Illegal harvesting of molluscan shellfish from contaminated or unclassified waters is known to occur (Ref. 7, p. 331). It is also known that illegally harvested shellfish find their way into commercial channels. States and FDA find untagged or improperly tagged shellfish during their inspections of shellfish processors under the cooperative program (Refs. 101 through 109). FDA frequently lacks a basis for taking action against untagged shellfish (Ref. 110). Proposed Sec. 1240.60 will provide a basis. Second, State tagging requirements and sanctions are not uniform, and the sanctions provided under some State laws have little deterrent effect (Refs. 102, 103, and 109). The establishment of a Federal sanction will provide illegal harvesters with sure knowledge that if their catch enters interstate commerce and comes to the attention of FDA, it will be destroyed. If Sec. 1240.60(b) is adopted, as a practical matter, product identification will begin at the harvesting site. FDA is proposing to amend Sec. 1240.60 to require that the first handler of live molluscan shellfish, be it the licensed harvester, licensed aquaculturist, or certified shellfish shipper, affix a tag to each container of shellfish. The tag will then provide the means for processors to ensure that the shellfish that they buy is from properly classified water. Moreover, the tag will provide all information that is necessary to trace the product to its source, e.g., date of harvest, location of harvest, quantity and type of shellfish, and the harvester's name and identification number assigned by the shellfish control authority. The product traceability that results will enhance epidemiological investigations in the event of shellfish-borne illness. It will also facilitate prompt remedial actions necessary to reestablish public health controls. The safety concerns about shucked molluscan shellfish are substantially the same as those discussed above for in-shell molluscan shellfish. Because shucked shellfish are packaged in a container that can be labeled, the agency is proposing to require in Sec. 1240.60(c) that for these shellfish, a label may be substituted that bears information equivalent to that found on the tag. Another reason for allowing labeling in lieu of a tag is the fact that one bag of unshucked molluscan shellfish bearing a single tag can typically be processed into more than one container of shucked molluscan shellfish. The second measure that FDA is proposing is based on its experience with the NSSP and the ISSC. FDA has tentatively concluded that the system for protecting the safety of shellfish can be significantly strengthened if the agency were to require that certain limited steps be taken as part of the processing of shellfish that are intended for interstate commerce. FDA believes that these measures, like the proposed tagging requirement, will serve to strengthen the Federal- State cooperative program as well as the shellfish safety programs of each of the States and countries that participate in NSSP. Many of the pathogens in shellfish, such as the Norwalk virus, are virtually undetectable. Moreover, from a technical and practical perspective, end product testing cannot be used in the processing of shellfish to ensure that they are not contaminated with one of the myriad of possible domestic, industrial, and agricultural contaminants that have been found in shellfish harvesting areas. Therefore, State classification of growing waters is a necessary first step to ensure the safety of shellfish. These classifications, as detailed in NSSP, address all actual and potential pollutants in deciding whether an area is suitable for harvesting (Ref. 90, pp. c-5 and c-6). FDA is proposing in Sec. 123.28(a) that each processor of shellfish have an HACCP plan that ensures that the molluscan shellfish that it processes come only from areas that have been classified by a shellfish control authority as satisfactory for harvesting. As noted above, the safety of molluscan shellfish consumed raw or partly cooked is predicated on the cleanliness of the growing area waters from which they are obtained. Ensuring that shellfish come from properly classified growing areas is where shellfish safety begins. Under proposed Sec. 123.28(b), processors are to process only shellfish that originate from growing waters that have been approved for harvesting by a shellfish control authority as shown by product tags or labels with specific information that establishes that they were harvested from appropriate waters. FDA is proposing this requirement under both section 361 of the PHS Act, to prevent the spread of communicable disease, and sections 402(a)(1), 402(a)(4), and 701(a) of the act to ensure that the food does not contain any added substances that may render it injurious to health and is not prepared, packed, or held under insanitary conditions whereby it may be rendered injurious to health. Under proposed Sec. 123.28(b)(2) and (b)(3), the shellstock tag from a licensed harvester or certified processor, or the bill of lading accompanying bulk shipments, will contain the information required under proposed Sec. 1240.60(b) and thus document whether the shellfish are from an acceptable source. The proposed requirement Sec. 123.28(b) that only shellfish drawn from such acceptable sources can be processed will place a premium on properly tagged products from shellfish dealers that States or nations that participate in NSSP have certified. The agency is further proposing to require in Sec. 123.28(c) that shucked products be subject to the same requirements that apply to shellstock. FDA is doing so because the safety of shucked shellfish products, like shellstock, depends on the quality of the water where they are grown. Therefore, the same requirements are needed. FDA is further proposing to require in Sec. 123.28(d) that the processor maintain records that document that each lot of shellfish meets the tagging or labeling requirements in Sec. 123.28 (b) or (c) (see Refs. 104 and 108). The information that FDA is proposing to require to be maintained in records simply reflects these requirements. Permanent records are needed to demonstrate that processors are controlling the origin of the shellfish they process. In addition, permanent records will facilitate epidemiological investigations by allowing complete product traceability to the source of origin. The protection of shellfish consumers also requires that domestic and imported products be treated equally. While imported raw molluscan shellfish are subject to the same standards as domestic shellfish with regard to adulteration and misbranding, Federal law does not require that imported shellfish come from waters that were classified by a public health authority. This double standard is unfair to domestic processors, and both ISSC and industry representatives have urged the Federal Government to address this problem (Refs. 111 and 112). While virtually all States have chosen to reject imported shellfish that are not tagged as coming from classified waters (Ref. 113), it is known that such shellfish nonetheless enter interstate commerce (Ref. 107). Untagged imports originating from uncertified producers compromise the effectiveness of seafood safety programs (Ref. 7, p. 73) and product traceability. Therefore, FDA is proposing that all raw shellfish products either from domestic or foreign origin must comply with the requirements in part 123 and Sec. 1240.60. Thus, if Sec. 123.28(b), for example, is adopted, it will mean that only those molluscan shellfish that are harvested in a foreign country that has a program that incorporates the type of measures set out in the NSSP for approving growing waters will be appropriate for processing. Such a program will need to include measures that provide for water classification, monitoring, and other related activities if it is to ensure that the growing waters that it approves are safe, and thus that the shellfish that are drawn from such waters are not adulterated. FDA has found that the best way to establish that a foreign country's program meets this standard is through the development of an MOU between the agency and that country. Currently, such agreements exist with Australia, Canada, Chile, England, Iceland, Japan, Republic of Korea, Mexico, and New Zealand. In summary, FDA anticipates that these proposed requirements will improve the safety of raw molluscan shellfish by establishing uniform requirements for domestic and imported products and prohibiting interstate movement of shellfish that is not properly tagged to demonstrate that it came from an appropriate harvesting area. The effectiveness of State shellfish sanitation programs and the NSSP will be strengthened by the proposed mandatory tagging, labeling, and recordkeeping requirements, which will allow complete product traceability to its source of origin. Should illnesses occur, product traceability will facilitate a rapid determination of when a problem occurred and allow immediate remedial actions to restore public health controls. Also, requiring proper tagging or labeling will place a premium on State and foreign shellfish sanitation and processor certification programs. J. Guideline for Cooked, Ready-to-Eat Fishery Products FDA is proposing a guideline in Appendix A for cooked, ready-to-eat fishery products. These products possess an elevated microbiological risk relative to most other seafood products because they are cooked as part of processing and do not normally receive any additional cooking by consumers before consumption. Consequently, to be safe, these products must be essentially pathogen-free by the time they leave the processing facility. Immediate refrigeration at proper temperatures to prevent the growth of pathogens is also essential for these products, which are not shelf-stable. The guideline addresses critical control points that apply to these products as a class and that thus will typically be identified in the HACCP plans of most processors of cooked, ready-to-eat products. The guideline also addresses ways of controlling hazards at each critical control point. Processors of cooked, ready-to-eat products that are also smoked and smoke-flavored fishery products should apply the controls set forth in Appendix 1. If FDA adopts that regulation, it will codify it in reserved subpart B of part 123. This guideline is not relevant to most of the cooked, ready-to-eat products that are processed as low acid canned foods under part 113. However, the recommendations in Appendix A, section 4. a., b., and d. for cooling, processing after cooking, and refrigerated storage, will apply to those low acid canned foods that are cooked, processed, and then cooked again. The guideline provides information on how to control the growth of S. aureus during the processing step between cooks. It also addresses the control of microbiological hazards that can occur within the processing environment for cooked, ready-to-eat products. It does not address nonprocessing hazards, because they are not relevant to this class of products. FDA intends to publish separate guidance that will, among other things, address nonprocessing hazards. Likewise, this guideline will not address the nonsafety hazards, such as decomposition that is not associated with human illness and economic adulteration, that FDA has suggested in proposed Sec. 123.6(c) should be covered by the HACCP plan. These hazards will also be covered in the separately published guidance. Economic adulteration, for example, is addressed in Appendix D. FDA has tentatively decided to address the processing controls for cooked, ready-to-eat products in a guideline, rather than by regulation, to permit flexibility in the face of changing processing technologies and knowledge. As stated earlier in this preamble, the guidelines are intended to advise processors about what FDA believes will be acceptable in a HACCP plan. The agency acknowledges, however, that there are basic processing norms to which conscientious processors adhere, and that these norms are not likely to change for the foreseeable future. FDA therefore invites comments on whether any or all of the guideline on the cooked, ready-to-eat products ought to be codified as requirements in part 123 if it is adopted as a final regulation. 1. Thermal Processing: Cooking and Pasteurization Processes and Equipment The proposed guideline in Appendix A, section 4 advises processors on how to ensure that: (1) Their cooking and pasteurization processes are adequate to inactivate pathogens; and (2) their cooking and pasteurization equipment is adequate to deliver their cooking and pasteurization processes. A cooking process is, in essence, the temperature and time at that temperature that will both kill pathogens and create a marketable product. A pasteurization process is the temperature and time at temperature that is necessary to reduce the numbers of pathogens to the point where they will not cause harm over the shelf life of a refrigerated product. It is essential that C. botulinum type E not survive the pasteurization process for cooked, ready-to-eat products that are packed in hermetically sealed containers and held at refrigerated temperatures (Ref. 52). Such containers are typically vacuum or modified atmosphere packaged and thus can provide a good environment for the growth of C. botulinum type E. To meet the requirements in part 123, subpart A, processors must have assurance that their cooking and pasteurization processes are adequate to inactivate pathogens and must document this assurance in their HACCP records. This approach is similar to that in the regulations for low acid canned foods, which require that processors of those products know that their thermal processes are adequate to destroy C. botulinum. The low acid canned food regulations do not specify to processors what their time/temperature parameters must be in order to destroy those pathogens. There are simply too many variables and possibilities with regard to thermal processing parameters for this kind of specificity in those regulations to be practical or appropriate. Rather, the regulations require that processors use a thermal process that is at least equivalent to one established by a competent process authority, i.e., a third party who has the expertise to determine the parameters of a thermal process that will destroy pathogens (Ref. 85). This approach has served the consuming public, the agency, and the industry well over the years. FDA is therefore recommending in proposed Appendix A, section 4. a.1. and b.1. that processors utilize the services of process authorities to establish the parameters of their cooking and pasteurization processes. A process authority could be a private individual, a member of academia, or an agency of government. Processors can find competent process authorities through their trade associations, local Sea Grant extension offices, or State universities. The procedures that are used in establishing a cooking or pasteurization process should be generally recognized and accepted. Such procedures may include thermal death time, heat penetration, and inoculated pack studies, as necessary, to establish the minimum process necessary to destroy pathogens. In cases where the cooking process or pasteurization process is standardized and not unique to a specific processor, articles in journals; Federal, State, or local regulations and guidelines; or other appropriate vehicles could provide process parameters (Ref. 52). Whatever the source, processors must retain the documentation from the process authority that the process will be effective as part of their HACCP records, in accordance with proposed Sec. 123.8(c). The process established by a process authority should include values for those aspects of the process that can affect the destruction of pathogens. The most notable of these are cooking times and temperatures. Others may include the initial internal temperature of the cooking medium before the cooking, the product size and species, and the viscosity of formulated products such as soups. FDA is already aware that the cooking processes necessary to create a marketable product for several types of cooked, ready-to-eat products are many times more lethal than necessary to inactivate pathogens (Ref. 114). The products are the several types of crabs listed in the guidelines at proposed Appendix A, section 4.a.4. FDA has tentatively concluded that, for these products, the adequacy of both the cooking process and cooking equipment can be assumed. It is likely that other products could be added to this list. The agency invites comments on this point. Comments should be accompanied by data that will enable the agency to determine that the minimum cooking process necessary to achieve a marketable product, e.g., heat penetration data and data on the range of cooking processes (times and temperatures) applied to that product, will produce a safe product. The same general principles also apply to the design of the cooking and pasteurization equipment. It is necessary that this equipment be designed and operated so that every unit of product receives the established minimum cooking or pasteurization process proposed (Appendix A, section 4. a.2. and b.2.) (Ref. 85). FDA recommends that the equipment be evaluated for design and operation by a process authority who is familiar with the dynamics of temperature distribution in processing equipment. In some instances, temperature distribution studies may be necessary to establish the adequacy of the equipment. In other instances, existing literature should be sufficient. Processors must obtain and retain documentation that the equipment will provide the minimum process as part of their HACCP records in accordance with Sec. 123.8. 2. Container Integrity The proposed guidelines advise in Appendix A, section 3. c. and d. that HACCP plans prepared in accordance with part 123, subpart A will normally identify finished product container sealing for pasteurized products and postpasteurizing cooling as critical control points. Contamination with C. botulinum type E during the postpasteurization cooling step is a special food safety hazard that must be controlled for pasteurized products. Two potential causes of recontamination are poor container seams and contaminated cooling water. Consequently, the guidelines, at Appendix A, section 5, recommend controls that processors can utilize that are likely to meet the requirements of subpart A. Appendix A, section 5.a. advises processors how to inspect finished product containers of pasteurized products for container integrity to ensure a consistently reliable hermetic seal. At proposed Appendix A, section 5.b., the guidelines advise about testing for the presence of sanitizer in cooling water. Seam inspections should determine whether the seams conform to the manufacturer's guidelines. Additionally, because of variations from seaming head to seaming head, from closing machine to closing machine, and over time for any one machine or head, FDA recommends that processors conduct inspections for each machine and head at least every 4 hours. Visual seam inspections are not adequate to fully assess the integrity of the seam. Physical testing and, in the case of double seams, seam teardown and measurement, are necessary parts of the inspection, as presently required for low acid canned foods in part 113. The presence of sanitizer in cooling water provides a control for the risk of microbiologically contaminated water being drawn into the can. A vacuum created by a collapse in the cooling vat of the steam head in the container, generated during the heating step, can draw in a minute amount of cooling water and any pathogens contained in that cooling water. Seams are in a particularly stressed condition at that time. Sanitizer strength levels should be checked periodically because there is a tendency for variation in strength to occur, particularly in batch-type systems. 3. Time and Temperature The guidelines advise, in proposed Appendix A, section 3. e., f., g., and h., that HACCP plans prepared in accordance with subpart A of part 123 will normally identify cooling after cooking, processing after cooking, final product cooling, and refrigerated storage, as critical control points. The potential exists for some pathogenic microorganisms to survive the cooking process, regardless of the controls that are in place at that step. Likewise, despite a processor's efforts to minimize recontamination of the cooked product with pathogens, the potential exists for some pathogens to be reintroduced. For these reasons, it is imperative that exposure of the product after the cooking process to temperatures that permit the growth of pathogens be kept to a minimum, since larger numbers are frequently associated with a greater potential for disease. To control hazards as required by part 123, subpart A, the process must take steps to restrict time/temperature abuse of the cooked product to the point that pathogens such as Salmonella spp. do not enter the rapid (logarithmic) phase of growth. By restricting pathogen growth to the slow (lag) phase, pathogen numbers should remain constant or increase only slightly. Proposed Appendix A, section 6.a. provides a way to control the growth of pathogens immediately after cooking. It advises that, after cooking, the product should be cooled from 140 deg.F (60 deg.C) to 70 deg.F (21.1 deg.C) within two hours. This time/temperature combination is based on the upper limit for growth (i.e., 140 deg.F) and the lower limit for rapid growth (i.e., 70 deg.F) of such mesophilic pathogens as Salmonella spp. and S. aureus, and the typical length of the lag phase for the former microorganism (Refs. 23, 85, and 115). However, 70 deg.F (21.1 deg.C) will not fully control the growth of psychrotrophic pathogens. Consequently, further cooling from 70 deg.F (21.1 deg.C) to 40 deg.F (4.4 deg.C) within 4 additional hours is advisable, based on the minimum growth temperatures of such psychrotropic pathogens as L. monocytogenes, Salmonella spp., and S. aureus, and the lag time of Salmonella spp. (Refs. 23, 78, and 79). These cooling recommendations are generally consistent with those of the Food Safety and Inspection Service (FSIS) of USDA (Ref. 115) and the National Food Processors Association (NFPA) (Ref. 78). FDA invites comments on the specifics in App. A, section 6.a. In those instances where further processing takes place before the achievement of the 70 deg.F (21.1 deg.C) or the 40 deg.F (4.4 deg.C) temperatures, further reduction in temperature need not take place. There is no need for production delays when in-process storage times are normally less than the 2 or 6 hours needed to achieve each of these temperatures. The time/temperature parameters employed to control the microbiological hazards associated with cooling after cooking can be confirmed by a program of routine time and temperature monitoring (Appendix A, section 6.a.1.). Real time documentation of this monitoring should be done to facilitate management and regulatory review. Alternately, the ability of the firm's processing procedures to consistently achieve the appropriate time/temperature parameters can be confirmed through scientifically conducted time/temperature studies that take into consideration the range of processing variations encountered at the firm. Examples of processing variations include product size, e.g., the range of shrimp sizes that the firm typically processes; the temperature of the cooling medium, e.g., the highest temperature normally experienced in the firm's cooling unit; and the amount of product normally placed in the cooling unit. In some instances in-process time/temperature monitoring may be impractical or needlessly redundant, particularly in continuous processing systems. A scientifically conducted study is especially appropriate for such situations, where it can be assured that in all plausible situations the time/temperature parameters will be met. Documentation and retention of the conduct and results of this study is required by Sec. 123.8. Appendix A, section 6.b. advises how processors can ensure that microbiological hazards associated with postcooking processing can be controlled. It advises that products not be exposed to ambient temperatures of 40 deg.F (4.4 deg.C) or higher for more than 4 hours during postcooking processing, again based on the minimum growth temperature of such psychrotropic pathogens as L. monocytogenes and on the normal lag phase of such mesophilic pathogens as Salmonella spp. The agency recognizes that, for many products, manipulation of the product after cooking, while undesirable from the standpoint of microbiological recontamination, is necessary for many cooked, ready- to-eat products. It is often impractical to perform this manipulation under refrigerated conditions. Consequently, the product will be exposed to some combination of time and temperature that may allow for microbiological growth. The recommended conditions will minimize the growth of pathogenic microorganisms and the production of heat stable toxins (e.g., staphylococcal enterotoxin). The ability of the firm's processing procedures to consistently achieve its time/temperature parameters can be confirmed by monitoring the length of time that the product is exposed to such ambient temperatures. Documentation of time/temperature monitoring must be in accordance with Sec. 123.8. to facilitate management and regulatory review. Appendix A, section 6.c. advises how processors can ensure that microbiological hazards associated with final product cooling can be controlled. Following the manipulation of the product during postcooking processing, it will be necessary for the processor to cool the product to a temperature that will not support the further growth of mesophilic or psychrotropic pathogens. This result can be achieved by cooling the finished product to an internal temperature of 40 deg.F (4.4 deg.C) within 4 hours of either placing it in the finished product container or completing pasteurization. Again, the recommendation is based on the minimum growth temperature of such psychrotropic pathogens as L. monocytogenes and on the normal lag phase of such mesophilic pathogens as Salmonella spp. Of specific concern to the pasteurization process is the reduction of the internal temperature of the product to a level that will not support the growth of any surviving spores of C. botulinum, type E. The ability of the firm's processing procedures to consistently achieve its time/temperature parameters can be confirmed by a program of routine time and temperature monitoring designed to address the particulars of the firm's processing system. Real time documentation of this monitoring should be done to facilitate management and regulatory review. Alternately, the firm's ability to consistently meet its parameters can be confirmed through scientifically conducted time/temperature studies that take into consideration the range of processing variations encountered at the firm. Examples of these processing variations include container size, the temperature of the cooling medium, and the amount of product normally placed in the cooling unit. In many instances, in-process time/temperature monitoring may be impractical and expensive for sealed finished product containers. A scientifically conducted study is especially appropriate in such situations, where it can be assured that in all plausible situations the time/temperature constraints will be met. Documentation of the conduct and results of the study is required under proposed Sec. 123.8 to facilitate management and regulatory review. Temperature control during refrigerated storage is best achieved through the use of temperature indicating and recording devices and recordkeeping, as stated in Appendix A, section 6.d.2. (Ref. 85). However, FDA recognizes that some processors may desire to manually monitor the temperature of the refrigeration unit, using only a temperature-indicating device and a logbook. When coupled with a high temperature alarm or a maximum-indicating thermometer, the agency feels that this practice represents an acceptable alternative. The guideline advises, in Appendix A, section 3.i., that HACCP plans prepared in accordance with subpart A of part 123 will normally identify distribution as a critical control point. Distribution of perishable products encompasses the same hazards as associated with refrigerated storage. For this reason, in Appendix A, section 6.e., the agency is recommending a critical limit of an internal temperature maximum of 40 deg.F (4.4 deg.C) and is encouraging the shipper and consignee to arrange for appropriate control measures. The agency recognizes that distribution patterns vary considerably from single shipments to pooled and multiple delivery shipments, from iced shipments to refrigerated shipments, and from shipments on the consignee's truck to shipments on the shipper's truck to common carrier shipments. Each mode presents different opportunities and impediments for control. 4. Temperature Monitoring Equipment Processors must monitor and control the temperature of their refrigeration units in order to ensure that microorganisms of public health concern do not increase in numbers. Likewise, processors must control the times and temperatures of their thermal processes in order to ensure that the minimum thermal process is consistently delivered to the product. The guidelines address the outfitting of cooking, pasteurization, and refrigeration equipment with temperature indicating and recording devices (Appendix A, sections 4. a.2.ii. and b.2.ii., and section 6.d.2., respectively). A temperature-recording device provides a complete history of the temperature throughout the thermal process by continuously recording it on a chart. As has been demonstrated for low acid canned foods, the chart itself provides an excellent HACCP record for the benefit of both processor and regulator. For this record to be meaningful, it is critical that the temperature-recording device sensor be installed so as to accurately represent the temperature of the heating or cooling medium. Temperature-recording devices are easily jarred and rendered inaccurate. They can be calibrated and corrected against a temperature- indicating device (e.g., a thermometer) quite easily, however. Processors should do so at least at the beginning and end of each production day in order to determine whether the instrument was accurate throughout the day's production. In this situation, the temperature-indicating device serves as reference instrument since it is much more reliable. Consequently, the temperature-recording device should never show a higher temperature than the temperature-indicating device. Temperature-indicating devices are generally reliable and need only be calibrated upon installation and annually thereafter. Calibration should be against a standardized (i.e., traceable to the National Bureau of Standards) thermometer that is not subject to the rigors of the processing environment (Ref. 85). Temperature-indicating devices must often be read under less than ideal plant conditions, so they should be installed in a location that facilitates easy reading. As with the temperature-recording device, the sensor on the temperature- indicating device should be installed so as to accurately represent the temperature of the heating or cooling medium. 5. Corrective Actions Appendix A, section 8. advises processors about corrective action steps that they should consider to comply with the proposed corrective action requirements in Sec. 123.7 of subpart A. Because the evaluation of critical limit failures relating to the cooking step and the terminal heat treatment step of cooked, ready-to-eat products may well require an understanding of the technical aspects of thermal process calculations, Appendix A, section 8. recommends additional controls to those required by Sec. 123.7 in this regard. Of primary importance is the recommendation that any corrective action other than processing to eliminate the hazard or destruction must be assessed by a competent process authority. For this purpose, a process authority may be a representative of the firm or may be an outside source, so long as the process authority has a scientific background that is adequate to make the assessment. 6. Sanitary Zones Section 123.10 of subpart A establishes requirements for all processors for sanitation within the processing environment. In addition to these requirements, this guideline recommends in Appendix A, section 8. that processors of cooked, ready-to-eat products establish sanitary zones in their facilities. The agency invites comments on the merits of this concept and on whether it should be codified in the regulations. The importance of good sanitation in the processing of cooked, ready-to-eat products cannot be overemphasized. While, as has been stated earlier, plant sanitation has no real bearing on human food safety for many foods, the safety of cooked, ready-to-eat products can be easily jeopardized by pathogens that are introduced through poor sanitation practices. Consequently, FDA is recommending that processors establish sanitary zones around areas where products that have already been cooked are being handled or stored. The primary purpose of a sanitary zone is to physically separate insanitary objects from cooked products. Sanitary zones can also minimize the likelihood of airborne contamination through proper filtration and positive air pressure in the zone. A sanitary zone is a separation of operations by location, partition, air flow, or enclosed systems. In most cases, it requires procedural changes to minimize the risk of contamination but not large- scale structural changes. Canada has successfully incorporated the concept of sanitary zones for seafood processing as part of its HACCP- based inspection program (Ref. 116). K. Guideline For Scombroid Toxin Forming Species FDA is proposing a guideline in Appendix B for handling of the species in which scombroid toxin can form. This problem is primarily, but not exclusively, associated with members of the family Scombridae. The fish involved contain significant levels of naturally occurring free histidine in their flesh, which certain bacteria can decarboxylate into histamine. Significant histamine levels occur when the fish are exposed after death to times and temperatures that permit the growth of these bacteria. Histamine can result in a mild to severe allergic response in humans. Scombrotoxin poisoning is one of the three most common seafood-related illnesses (Ref. 5, p. 24). The scombrotoxic species that have been associated with foodborne illness include tuna, bluefish, mahi, mackerel, sardines, herring, kahawai, anchovies, and marlin. This HACCP guidance is intended to maximize the use of controls to ensure proper handling of scombrotoxic species and thus to minimize the possibility of a problem. It also recognizes the often complex pathways of movement and ownership through which such fish may pass. Failure to ensure safe handling at any point in the chain may render the fish injurious to health. There is a basis for concern about the safety of the fish as soon as histamine begins to form. Once the histamine-forming process has begun, it is like a chain reaction. Lowering the temperature of, or freezing, the fish will slow or arrest the process, but only cooking and prevention of recontamination can stop it (Refs. 9 and 117). The guideline describes a HACCP system that emphasizes reliance upon accurate recordkeeping to show continuity of proper handling. Accurate knowledge of the time/temperature history of the fish is very important in determining the likelihood that the fish are unsafe or may become unsafe. The guideline also calls for more stringent processor controls to be applied to lots for which records are inadequate. While this guideline is designed to prevent problems, nothing in it should be construed as meaning that the agency will not take regulatory action if it finds decomposed fish. The guideline in Appendix B, section 2. identifies receipt of raw materials, which include imported shipments, as a critical control point for processors of scombroid toxin forming species. Time/ temperature abuse by the fisherman can result in decomposition and the resultant production of histamine. Decomposition can also occur before the fish are removed from the harvest water if the fish dies in capture nets or on long lines. In such an event, the degree of decomposition will reflect the sea temperature, time in the water, and particular species (Ref. 118). It is not uncommon to encounter water temperatures of 80 deg.F to 90 deg.F in tropical waters, which can produce rapid decomposition. Thus, rapid cooling of fish when they are captured is very important to prevent initiation of the process by which histamine is produced. Fish subjected to 68 deg.F for periods as short as one day, a practice which can happen in warm climates on fishing vessels, will yield high levels of histamine, even if the fish are later stored at refrigerated temperatures (Ref. 117). For these reasons, the guideline advises that processors of fish and fishery products from scombroid toxin forming species must ensure that their raw materials are essentially free of decomposition and histamine as a result of time/temperature abuse that occurred before the processor received them. The guideline provides for three interrelated controls for the processor to apply with regard to raw materials. For the first processor that takes ownership after harvest, these are: (1) Time/temperature records from the harvesting vessel (Appendix B, section 3.a.1.); (2) organoleptic examination of the fish from the harvesting vessel for decomposition (Appendix B, section 3.a.2.); and (3) histamine analysis, if warranted by the time/ temperature history of the fish as revealed by the time/temperature record from the vessel or by the results of the organoleptic examination (Appendix B, section 3.a.3.), or both. Time/temperature records from the vessel indicate whether entire lots from the vessel may be suspect, and thus in need of a histamine examination, because of unusual events on the vessel. Such records would not normally reveal, however, whether there are individual fish in the lot that may have decomposition. An organoleptic examination for decomposition serves to screen individual fish. It also serves as a way to verify the time/ temperature records from the vessel with regard to an entire lot. If organoleptic examination reveals an unusually high number of fish with decomposition, the entire lot should be considered suspect and subjected to histamine analysis. Appendix B, section 3.a.1. provides for how the first processor can take measures to determine whether the fish were properly harvested and handled on board the harvesting vessel. Certification of the mode of capture, including information on the time between physical capture and bringing the fish on board, handling techniques, and the use of temperature logs onboard the vessel that record that time/temperature history of the fish (for example, catch date and time, means and rate of cooling, storage temperature, and refrigerated brine or seawater temperature) provide documentation to the processor and to regulatory authorities that the fish were properly handled. Such records on the handling of the fish should be part of an HACCP system and can be used in the specific HACCP plans of processors. The harvester's goal should be to bring the fish to an internal temperature of 40 deg.F (4.4 deg.C) or below as soon as possible after the fish dies to minimize the risk of histamine production. Cooling fish below 59 deg.F (15 deg.C), and preferably below 50 deg.F (10 deg.C), greatly reduces the growth of populations of the bacteria that are most likely to cause histamine formation (Ref. 7, p. 95). Once bacterial growth has begun, temperature at or below 41 deg.F (5 deg.C) halts bacterial growth, although enzymatic histamine formation may slowly continue (Ref. 7, p. 95). Consequently, in proposed Appendix B, section 3.a.1., the agency is recommending a slightly lower flesh temperature of 40 deg.F (4.4 deg.C) or below. This temperature is consistent with recommendations of safe temperatures in other sections of the proposed regulation. Nonetheless, FDA specifically invites comments on the appropriateness of this temperature. Appendix B, section 3.a.1. recommends that the time/temperature history from the vessel be on a lot-by-lot basis and defines a lot as a discrete storage compartment on the vessel in keeping with industry practice. A lot typically reflects a day's catch. Because a boat's catch can be subject to varying conditions and treatment from day-to- day, the time/temperature records should be specific to each lot. If the time/temperature records suggest that, for a particular lot, the conditions on the vessel were likely to cause, or significantly contribute to, the formation of histamine in the fish, or if no adequate time/temperature records exist for that lot, the guideline provides that a representative sample of fish from the lot be analyzed for histamine Appendix B, section 3.a.2.ii.B.). The samples should be collected on a statistically valid sample schedule because variations in time/temperature abuse are likely at various points in a ship's hold. The second control, organoleptic examination by the processor for decomposition, should be performed regardless of what the time/ temperature records show (Appendix B, section 3.a.2.). First, decomposition is a form of adulteration under 403(a)(3) of the act. Second, as indicated earlier, an organoleptic examination provides a screening mechanism for individual fish. It is possible for the conditions on the vessel to be good but for some fish to develop decomposition anyway. Third, also as stated earlier, an examination for decomposition provides a way to verify the time/temperature records. FDA recognizes that an organoleptic examination of each fish can be highly impractical. Consequently, the guideline calls for an examination of a representative number of fish to achieve a 95 percent certainty that the total number of fish in the lot that exhibit decomposition does not exceed 2.5 percent. (The significance of 2.5 percent is addressed in the preamble discussion of Appendix B, section 3. a.2.iii. and a.2.iv.) Using this approach, the number of fish examined will be reasonably close to the total number of fish, so that the goal of screening individual fish is preserved to the maximum extent practicable. Additionally, FDA expects that this representative sample will be large enough so as to provide a sufficient verification of the time/temperature records for the entire lot. Appendix B, section 3.a.2.i. provides that no fish flesh that exhibits any organoleptically detectable decomposition should be used for food. Aside from the clear violation of 402(a)(3) of the act presented by such decomposition, the public health risk presented by decomposition in scombrotoxin forming species is unacceptable. While the existence of decomposition does not mean that scombrotoxin is present, it does mean that a process has begun that can lead to the presence of scombrotoxin over the shelf life of the fish or fishery product. In some instances, e.g., large fish such as tuna, isolated parts of the fish will exhibit decomposition but other parts will be free of decomposition. FDA recognizes that it is possible to remove those parts of a fish that have decomposition and salvage the remainder. Appendix B, section 3.a.2.i. provides for such reconditioning so long as a histamine examination is performed on the flesh that is free of decomposition. FDA believes that a histamine test is prudent under such circumstances to verify that scombrotoxin forming processes are not at work in that flesh. The guideline also provides for how the processor should use organoleptic examination and time/temperature records in tandem to determine whether fish or fishery products from scombroid forming species are fit for further processing or should first be subject to a histamine examination. If no decomposition is found, and the time/ temperature records show that conditions on the vessel were unlikely to cause, or significantly contribute to, the formation of histamine in the fish, all the fish from that lot may be further processed or directly entered into commerce (Appendix B, section 3.a.2.ii.). If, as stated earlier, the time/temperature records are inadequate or indicate conditions that could cause histamine, the processor should always conduct a histamine analysis on a representative sample regardless of the decomposition findings. If decomposition is found in less than 2.5 percent of the lot, and the time/temperature records show that conditions on the vessel were unlikely to cause, or significantly contribute to, the formation of histamine in the fish, Appendix B, section 3.a.2.iii. provides that the decomposed fish should be removed in accordance with the procedure outlined in Appendix B, section 3.a.2.i., but that it is not necessary to subject the lot to a histamine examination. The agency has tentatively concluded that decomposition below 2.5 percent is not significant in terms of the acceptability of the entire lot. Under the best conditions, it is possible that some fish in a large lot will experience some minimal decomposition. Under these circumstances, so long as the fish with decomposition are culled from the lot, there is no reason to suspect that the lot has been subject to unusual conditions that could cause histamine or scombrotoxin to form. The agency is aware that the canned tuna industry uses the 2.5 percent value to determine whether special handling of a lot is warranted (Ref. 119). The canned tuna industry has concluded, just as FDA tentatively concludes, that levels above 2.5 percent represent likely exposure of the fish in a lot to conditions that are out of the ordinary and potentially dangerous. For these reasons, if the processor finds decomposition in more than 2.5 percent of the fish from a lot, those fish must be removed from the lot, and a histamine examination needs to be performed on a representative sample of the remaining fish in that lot (Appendix B, section 3.a.2.iv.). It is important to recognize that where the time/temperature records are inadequate for all the fish on a vessel, or show poor conditions for all the fish from a vessel, histamine analyses should be performed on representative samples from each lot on the vessel. Although an appropriate number of fish for sampling could possibly be provided from a single lot, the results would not be representative of the vessel as a whole. Appendix B, section 3.a.3. describes how fish should be disposed of depending on the results of a histamine examination. In keeping with current policy, the agency expects that any fish that is found to have histamine above a defect action level or other regulatory level or limit for histamine established by FDA will not be used for food. Moreover, the agency expects, as reflected in Appendix B, section 3.a.3.i., that a finding of histamine over such level or limit in any fish in a lot from the vessel will result in the destruction of that entire lot, regardless of the percentage of decomposition that was organoleptically detected or the conditions on the vessel as indicated by the time/temperature records. Such a histamine finding strongly indicates that neither the records from the vessel nor the decomposition test (if the results were below 2.5 percent) are reliable. Histamine may be present in the absence of organoleptically detectable decomposition. Similarly, the agency expects, as reflected in Appendix B, section 3.a.3.ii., that a finding of histamine below the action level, but higher than is normally found in fresh fish (Refs. 120 and 121), in any fish in a lot will result in the immediate cooking of all the fish in the lot to ensure that scombrotoxin will not form over the shelf life of the fish. Cooking stops the histamine forming process once it has started. Without this cooking, any elevated temperatures later in the distribution system or in the home can result in a rapid elevation of histamine levels to hazardous levels (Ref. 117, p. 341). Appendix B, section 3.b. addresses raw materials controls that can be exercised by subsequent processors, i.e., those other than the first processor to take possession of scombroid toxin forming fish and fish products from a harvester. Assuming that the first processor has met its responsibilities with regard to raw materials as explained above, and has not caused a problem through improper handling during processing, subsequent processors should determine whether decomposition occurred during transfer from the previous processor. Consequently, the guideline provides, at Appendix B, section 3.b.1., that subsequent processors that do processing other than simply storing, should subject a representative sample of fish or fish products from each lot to an organoleptic examination. Any finding of decomposition in that sample should lead to organoleptic examination of the entire lot. If decomposition is found in more than 2.5 percent of the fish in the lot, the processor should perform a histamine examination on a representative sample of fish from the lot. These gradations are consistent with the expectations reflected in the guidelines for first processors. FDA has tentatively concluded these measures need not be taken by those who only store fish and fishery products. While time/temperature abuse can occur during storage, and thus scombroid toxin forming species must be held at appropriate temperatures (40 deg.F (4.4 deg.C) or below), the hazard of scombrotoxin in the finished product can be controlled by those who own the product or manipulate it during processing. As suggested above, time/temperature abuse can occur during processing as well as before the raw materials are received. It is important that processors identify critical control points and suitable controls that will protect fish and fish products that can form scombrotoxin from time/temperature abuse. As the guideline for scombrotoxin states in Appendix B, section 5., many of the controls for time and temperature in the guideline for cooked, ready-to-eat products should be applicable to the processing of scombrotoxin forming species. Such handling conditions are necessary to control histamine production. In addition, Appendix B, section 4. provides that products that are undergoing processing not be exposed to ambient temperatures of 40 deg.F (4.4 deg.C) or higher for more than 4 hours during that processing. The agency recognizes that for many products, manipulation under unrefrigerated conditions is necessary. The processor must be aware, however, that during such periods the product will be exposed to conditions that can lead to histamine formation. Appendix B, section 4. describes how to minimize this possibility. To comply with Appendix B, section 4., the processor should monitor the length of time that the product is exposed to ambient temperatures of 40 deg.F or higher. Documentation of the time/temperature monitoring controls will facilitate management and regulatory review. L. Guideline for Product Integrity 1. Economic Adulteration Economic adulteration occurs when a consumer is misled about the worth, amount, or identity of a food product and, therefore, unknowingly pays for value not received. Economically deceptive practices in the representation of a food's value may occur in a number of ways. Sections 402(b) and 403 of the act define the conditions and practices that result, respectively, in the economic adulteration and misbranding of a food. In addition, the Fair Packaging and Labeling Act, 15 U.S.C. 1451 et seq., requires that food packages and their labeling provide consumers with accurate information about the identity and net quantity of the contents, so that consumers can make fair value comparisons among products. While any food may be subjected to economic adulteration or to misbranding, fish and fishery products present distinctive characteristics and processing procedures that make them more susceptible to abusive economic practices than most foods. The great variety of finfish, shellfish, and crustacean species, as well as the multiplicity of products prepared from them, including fabricated surimi-based products that imitate actual seafoods, provide ample opportunity for both inadvertent and deliberate economic adulteration and misbranding practices that result in economic loss to the consumer. Most important among the characteristics that make seafoods vulnerable to abuse is the similar appearance of many finfish, in the whole, raw state, in the form of fillets, or as ingredients. Unlike the situation with the limited types of red meats and fowl, it is very difficult for most consumers to detect the substitution of an economically inferior species for a more valuable one that is declared on the label or in labeling (e.g., the substitution of rockfish for red snapper). Irrespective of the relative economic value of the substitute species, section 403(a)(1) of the act states that a food shall be deemed to be misbranded if its labeling is false and misleading in any particular. More specifically, a food is misbranded under section 403(b) of the act if it is offered for sale under the name of another food. If the substituted fish is less valuable than the species represented on the label or labeling, the product is also adulterated under section 402(b)(2) of the act, which states that a food shall be deemed to be adulterated if any substance has been substituted wholly or in part therefor. Consequently, it is a clear violation of the act when a finfish, shellfish, or crustacean is not correctly identified on its label or in its labeling. Furthermore, the misidentification of species may also have adverse public health consequences. Should an illness or outbreak occur from a seafood product, it is essential for proper diagnoses and treatment that public health investigators not be prevented from quickly identifying the exact cause or agent responsible in the food, and from tracing it back to the correct source of the food to prevent further sale and consumption. For example, in a seafood related incident that occurred in 1982, in New York, two men became ill shortly after eating a fish dinner in a restaurant. Species substitution caused investigators to erroneously suspect that the illnesses were caused by ciguatoxin because the food was identified as being red snapper, a species which could cause that illness. The food actually was mahi, a fish which is often associated with scombroid poisoning (Ref. 122). Scombroid poisoning is associated with high levels of histamine. FDA found that the fish mislabeled as red snapper had been shipped from Ecuador and processed in Panama. Had the fish been labeled as mahi, it would not have been permitted entry into the United States because FDA had an automatic detention for mahi from Ecuador at the time because of problems with high levels of histamine. Another instance involving species substitution resulting in a negative public health consequence occurred in Hawaii in 1987. Fifty illnesses, 32 of which required medical attention, were attributed to the consumption of limpets misbranded as ``Baby Abalone.'' The symptoms displayed were those of a histamine-type reaction. Because abalone is not one of the species expected to form histamine, substituting limpets for abalone put consumers at risk from a food that they had not intended to eat. Thus, accurate identification of species is essential to public health protection and prompt accurate diagnosis and treatment of illness when that protection fails. Processing practices traditionally used in the seafood industry also are easily abused to increase a product's weight, in the form of ice or water. For instance, frozen fillets, shrimp, crab legs, and other products are normally protected from dehydration (freezer burn) while frozen by the application of a light glaze of ice. A packer then includes added product in the package to compensate for the weight of the glaze. Excessive amounts of glaze, however, not compensated for in this manner, can deliberately be used to increase the apparent weight, and therefore the apparent value, of the product delivered. Percentage weight increases from overglazing are most dramatic for foods with high surface area to volume ratios, such as shrimp. Overglazing is a practice that violates section 402(b)(4) of the act because a substance has been added to increase a food's weight or to make it appear of greater value than it is. A similar type of fraud frequently results from oversoaking fish and shellfish meats in dip solutions. Dip solutions are customarily used to retard the natural loss of moisture (drip loss) from products such as scallops, which are particularly susceptible to drip loss. However, exposure to the dip may deliberately be prolonged to add weight in the form of water. Dip solutions may contain chemicals, such as sodium tripolyphosphate, that can greatly enhance the amount of water absorbed by the scallops. The net effect of such practices is to mislead the consumer into purchasing added water at scallop prices. Seafoods generally represent a high dollar value per unit weight compared with other foods, particularly crab, lobster, shrimp, and certain shellfish. Thus, even relatively modest percentage weight increases from abusive glazing or water uptake from dip solutions represent a substantial loss of value to the consumer. For the same reason, the potential fraudulent profit from similar practices of adding less valuable ingredients, such as breading on shrimp and fish sticks or water to shucked oysters, to increase the size or weight of products are enticing to unscrupulous processors. The agency believes that economic adulteration occurs with sufficient frequency in various seafood products to result in substantial losses to the consumer. Evidence of such economic adulteration usually comes to light indirectly, as a result of investigations that are carried out for other purposes. Fourteen and one-half percent of the samples of seafoods reported in 1986 as having adverse findings by eight FDA district offices were so listed because of product misrepresentation (Ref. 123). Similarly, FDA found that in fiscal years 1991 and 1992, 14.8 and 11.7 percent, respectively, of all consumer complaints involved complaints of economic problems (Ref. 60). Imported seafood products also are subject to significant levels of economic misrepresentation. In 1992, approximately 13 percent of all detentions of imported seafood involved some form of misbranding, such as false or misleading labeling, short fill, short weight, standard of identity, and omitted labeling (Ref. 124). Specific data on species substitution are available from The National Seafood Inspection Laboratory (NSIL) of NMFS, Department of Commerce. Data gathered for the 3-year period of 1990-1992 by the laboratory in conducting species verification tests requested by industry show that 59 percent of the samples labeled as cod, 57 percent of the product labeled as haddock, 56 percent of the product labeled as flounder or sole, and 51 percent of the product labeled as red snapper were not the species claimed on the label. While these data cannot be regarded as representative of industry-wide misbranding practices because the testing was not random, the results indicate a remarkably high incidence of species substitution. Moreover, these findings are consistent with other surveys (Ref. 35, p. 45). For example, a survey conducted in Florida to determine the extent of retail species substitution in the case of red snapper found that 64 percent of the fish fillets labeled for retail sale as red snapper were misbranded (Ref. 125). The prevalence of misbranding just this one desirable species is underscored by the observation: ``If all of the red snapper sold in the United States were genuine, the seas would long since have been swept absolutely clean of this species'' (Ref. 126, p. 41). While most States' regulations follow FDA nomenclature policy and regulations, misbranding practices are exacerbated by the failure of some States to require these common names for some species sold within the State. Red snapper again provides a case study in the extent of variation in acceptable nomenclature allowed for a species. Although not permitted when sold in interstate commerce, California regulations allow 12 species of rockfish to be labeled as ``Pacific red snapper'' within the State. Similarly, Oregon and Washington regulations also allow rockfish to be called ``snapper'' (Ref. 126, p. 305). Moreover, an even greater variety of imported species may be misrepresented as ``red snapper.'' Many in the seafood industry believe that economic abuse is one its most significant problems. A survey conducted by the National Fisheries Institute found that the Institute's membership supported mandatory inspection as a means of overcoming practices that pose a threat to the reputation of processors and packers adhering to scrupulous practices in the representation of their products (Ref. 127). General agreement was found to exist among processors, distributors, and importers, as well as retailers and restaurateurs, that abusive economic practices are widespread, including overglazing and overbreading of fishery products, inaccurate net weight measurement, and the substitution of inferior species for more valuable fish. In a similar industry study by the Southeastern Fisheries Association, members ranked problems with economic fraud (such as species identification, overglazing, and the use of phosphates) above all other seafood industry problems, except vessel handling practices (Ref. 128). 2. Recommended Adoption of HACCP-Based Methods Although the agency recognizes that HACCP was developed primarily to address safety, FDA believes that the proposed requirement in Sec. 123.6, for seafood processors to adopt HACCP methods to ensure the safety of seafoods provides an opportunity for processors to develop and apply effective control point procedures that they can use to ensure that seafoods comply with the provisions of sections 402(b) and 403 of the act, The Fair Packaging and Labeling Act, the seafood standards of identity promulgated in 21 CFR, and applicable compliance policy guides issued by the agency (Compliance Policy Guides 7108.01, 7108.03, 7108.04, 7108.12, 7108.13, 7108.14, 7108.21, and 7108.23). Consequently, the agency is proposing in Appendix D to establish a guideline for HACCP-based procedures to avoid economic adulteration and misbranding of seafoods. Following this guideline will enable processors to develop procedures and records that will establish that they are not engaged in any practices that would render their products economically adulterated. Clearly, however, guidelines cannot prevent economic fraud. The following guideline for product integrity lists critical control points covering raw material receipt, processing, and labels and labeling that processors and importers can incorporate in their HACCP plans. The agency believes that proper control begins with verification of the raw materials received by a processor. Therefore, in Appendix D, section 2.a., the agency is suggesting that, as part of their HACCP plan, processors and importers should include critical control points beginning with the receipt of raw materials. Ensuring that raw materials meet critical limits (e.g., correct species identification, net weight, additive identification) at the point they enter a processor's or importer's control is crucial. There are a number of ways to ensure that species are properly identified. Physical examination, as indicated in Appendix D, section 2.a.1. is the typical method of determining the identity of a species. The agency believes that most seafood processors and importers are knowledgeable about the species that they handle and would have personnel available at the point of receipt who could monitor the incoming shipments for species substitution. Expert consultation is another option for correctly identifying species. Processors or importers can also check the identity of seafood by employing laboratory services, as provided for in Appendix D, section 2.a.2. Protein chromatography is a laboratory method that can accurately establish the species of fish and fishery products (Ref. 50). Another option, Appendix D, section 2.a.3., is to receive raw materials certified by suppliers under either limited or general and continuing guaranties (section 303(c)(2) of the act (21 U.S.C. 333(c)(2)) and 21 CFR 7.12 and 7.13). In Appendix D, section 2.b., the agency points out that processors must ensure that the labels, labeling, and invoices of their finished products accurately list weight, count, size, and product identity, as well as the content of valuable constituents (i.e., that ingredient that the consumer identifies as providing the reason to purchase the product, for example, the shrimp in breaded shrimp). The content of the valuable constituents must be maintained as required by FDA's standards of identity regulations (21 CFR part 161, including: oysters, Pacific salmon, canned wet packed shrimp in transparent or nontransparent containers, frozen raw breaded shrimp, frozen raw lightly breaded shrimp, and canned tuna) or in accordance with FDA's compliance policy guides. More specifically, as in Appendix D, section 2.b.1., the species must be correctly identified by its common or usual name and be so represented on the label and labeling. To assist processors and consumers, FDA has developed both printed and database versions of the ``FDA Fish List'' to provide such guidance. Also specific requirements for such labeling are listed in Standards of Identity and the Common or Usual Name regulations (21 CFR, parts 161 and 102). Appendix D, sections 2.b.2. through b.5. are based on section 402(b) of the act. Under Appendix D, section 2.b.2., the processor needs to ensure that valuable constituents of the product are not omitted or abstracted. For example, breaded shrimp must contain the required weight ratio of shrimp to breading. Similarly, shrimp must be of the size and/or weight specified on the label or labeling. Under Appendix D, section 2.b.3., the processor needs to ensure that no substance is substituted wholly or in part for a valuable constituent. For example, substitution of crab flavored surimi cannot be used in whole or in part instead of crab meat in a product labeled as crab cake. Under Appendix D, section 2.b.4., the processor needs to ensure that damage or inferiority is not concealed in any manner. This means, for example, that bleaching or coloring of product to conceal its true nature or condition of wholesomeness is not acceptable. M. Additional Guidance--FDA Fish and Fishery Products Hazards and Controls Guide Including Specific Guidance on Smoked Fishery Products As an adjunct to its rulemaking to require HACCP procedures in the seafood industry, FDA is drafting an extensive guidance for processors to use in understanding and implementing HACCP principles for their operations. This guidance will provide information that processors and importers can use in the development of their HACCP plans. This information consists largely of an identification of hazards that can affect the safety of seafood and a review of control measures that can keep the hazards from actually occurring, or that can at least minimize the likelihood of their occurrence. FDA has included selected portions of the draft HACCP guidance as Appendix 1 to this proposal, so as to better inform the public about how this guidance will be structured and about the kinds of assistance that will be available to processors and importers who implement HACCP. The agency emphasizes, however, that this guidance is a work-in- progress and still being developed by FDA. Nonetheless, the agency seeks comment on the need for this guidance and the usefulness of the format the agency proposes to adopt. In addition, FDA is including in Appendix 1 specific guidance on time-temperature and salinity parameters and other matters for use in the HACCP plans of processors of smoked and smoke-flavored fishery products. While FDA is seeking comment on the guidance generally, it particularly seeks comment on the guidance on smoked and smoke-flavored fishery products. Material relevant to the safe processing of smoked and smoke-flavored fishery products is found in various sections of the HACCP guidance because this general guidance is primarily organized by hazard rather than by commodity type. However, the agency has gathered the materials relating to smoked and smoke-flavored fishery products into a single section of the guidance to facilitate use of this guidance by this industry, and to facilitate obtaining public comment on it. As stated above, FDA seeks public comment on the appropriateness of the materials relating to smoked and smoke-flavored fishery products as guidance, on their validity as guidelines, and on whether they should be made mandatory by incorporating them into any final regulation that results from this rulemaking. While no known outbreaks of botulism attributed to smoked fish have been reported since 1963, FDA believes that the failure by manufacturers to obtain information about the composition of hot- and cold-process products represents a potential health hazard. Without analytical results from the testing for water-phase salt and sodium nitrite levels, a manufacturer cannot determine whether the fish have been adequately processed to inhibit C. botulinum spore outgrowth and toxin production. The agency's concerns are underscored by the diversity of processing temperatures and salt levels used in the manufacture of these products, particularly the lower range temperatures and water-phase salt levels (Ref. 24). Finally, as stated above, the use of modified atmosphere and vacuum packaging with smoked and smoke-flavored fish products is also a source of concern. These types of packaging provide an anaerobic environment in which C. botulinum spores can grow out and produce botulin, the causative agent in botulism. When consumed, the toxin attacks the central nervous system and may cause death if untreated within 3 to 6 days. For all these reasons, FDA has tentatively concluded that some type of guidance that defines the procedures for the safe processing of smoked and smoke-flavored fish is necessary. Historically, fish have been smoked in order to preserve them. Today, the primary reason for smoking is to impart certain taste and texture qualities to the fish. There are essentially two types of smoked fish: (1) Those that are subjected to a ``cold process'' that leaves the fish soft and moist, with a delicate smoke flavor, such as lox, and (2) those that are subjected to a ``hot process'' that produces a less moist, firmer product with heavier smoke flavor, such as smoked whitefish. The processing of these fish basically involves: (1) Cleaning and gutting followed by (2) immersion in a brine solution or dry salt in order to salt them, (3) drying in a cool temperature to avoid bacterial growth, (4) smoking in a smoking chamber at a temperature and for a time necessary to achieve the desired ``cold process'' or ``hot process'' effect, and (5) packaging and cooling. The taste and texture qualities attributable to ``cold process'' smoked fish require much lower temperatures during the smoking phase of the process than those attributable to ``hot process.'' Salted fish may not be smoked at all. As with virtually all fish, the species used to make smoked fish are exposed during their lives to C. botulinum, a spore- forming bacterium that is ubiquitous in the marine and freshwater environment. Type E is the predominant type of C. botulinum found in fish, other aquatic animals, water, and sediment, although other types such as A, proteolytic and nonproteolytic B, C, D, and F also have been found in fish (Refs. 148 through 152). The concentration of C. botulinum spores that may be expected in and on a naturally contaminated fish is unknown, although it is reported to vary from one spore per 16 g of fish to one spore per 200 g (Refs. 153 and 180). Under certain conditions, C. botulinum can produce a toxin that causes botulism, a disease that attacks the central nervous system of humans and can cause death within 3 to 6 days of ingestion if not properly treated (Ref. 193). C. botulinum's ability to form spores means that in a dormant state, it can survive environments that are otherwise hostile to it. C. botulinum is ``anaerobic,'' meaning that air constitutes a hostile environment. When conditions become favorable, that is, when no air is present, the spores experience ``outgrowth'' during which toxin can be produced. In fish, C. botulinum spores are found in the intestines and can also adhere to the surface of fish. For these reasons, C. botulinum can be found in the environment of most any fish processor and cannot be totally eliminated using reasonable means. Moreover, even though a fish might be cleaned, gutted, and air packaged, some risk will still exist because C. botulinum spores can find their way into muscle tissue during processing. Muscle tissue below the surface of the fish can provide an anaerobic environment where outgrowth and toxin production can occur if time and temperature permit. Although the processing procedures in Appendix 1 are based on studies of the time-temperature and salinity conditions required to prevent the outgrowth of botulinum spores, these practices are also effective in the elimination of risk from other pathogenic bacteria such as L. monocytogenes. L. monocytogenes is a pathogenic bacterium that is widespread in the environment and that is commonly isolated from surface waters and other environmental samples. Thus the likelihood of finding this pathogen on the exterior surfaces and viscera of fish is high. Since 1983, several large outbreaks of human listeriosis have been linked to the consumption of contaminated foods (Refs. 130, 131, and 132), thereby demonstrating the etiologic importance of foodborne transmission of this disease in humans. Although listeriosis is a relatively rare illness (approximately 2,000 reported cases per year in the United States), the exceptionally high mortality rate, as high as 34 percent, makes this illness one of the leading fatal foodborne diseases in the United States. The highest incidence of listeriosis generally occurs in neonates, the elderly, pregnant women, and individuals suffering from compromised immune systems. However, there are instances in which apparently healthy individuals have contracted listeriosis (Refs. 130 and 133). The incidence of Listeria species (including L. monocytogenes) in frozen raw and cooked seafood products is reportedly as high as 61 percent (Ref. 136). Indeed, numerous seafood products have been shown to support growth of L. monocytogenes (Refs. 137 and 138). L. monocytogenes is capable of prolific growth on smoked salmon stored at 4 deg.C, even when test inocula as low as 6 organisms per gram (g) are applied to the surface of fish samples (Ref. 139). Seafoods other than smoked or smoke-flavored fish have been epidemiologically linked to two outbreaks and one sporadic case of listeriosis (Ref. 140). Furthermore, several cooked seafood products have been recalled from the market in North America because of contamination with L. monocytogenes, but these crises did not involve smoked or smoke- flavored fish products. A recent survey of smoked fish and smoked fish products in Iceland has shown that 29 percent of samples tested were contaminated with Listeria species, including L. monocytogenes (Ref. 141). Another survey revealed that 8.9 percent and 13.6 percent of hot- and cold-smoked fish, respectively, were contaminated with L. monocytogenes (Ref. 142). Cold-smoked fish may pose a significant health risk, particularly when stored for extended periods. When raw salmon was inoculated with known populations of L. monocytogenes and smoked at 78.8 to 86 deg.F (26 to 30 deg.C) for 6 hours, and the finished product stored at 39.2 and 50 deg.F (4 and 10 deg.C) for up to 30 days, investigators observed substantial increases in L. monocytogenes populations at both incubation temperatures (Ref. 143). No known cases of listeriosis have been linked to smoked seafood consumption in the United States. In contrast, studies have shown that properly controlled hot- smoking processes effectively eliminate L. monocytogenes contamination (Ref. 144). In raw trout inoculated with high doses of L. monocytogenes, stored for 12 hours in a marinade containing 10 percent NaCl, and then subjected to a hot-smoke process (dried for 30 minutes at 140 deg.F (60 deg.C), cooked at 230 deg.F (110 deg.C) until an internal temperature of 149 deg.F (65 deg.C) was maintained for 20 minutes, and finally smoked for 45 minutes at 140 deg.F), L. monocytogenes did not survive the smoking process. However, when fish were inoculated after smoking and stored at 46.4 to 50 deg.F (8 to 10 deg.C), a significant increase in L. monocytogenes populations was observed after up to 20 days of storage. These findings further emphasize the importance of preventing the contamination of processed fish. Studies have also shown the importance of controlling the salt concentration in smoked fish. Although L. monocytogenes can survive in environments containing up to 20 percent NaCl (Ref. 145), it has been demonstrated that the organism becomes increasingly more sensitive to NaCl when it is exposed to heat processing (Ref. 146). Because of the prevalence of L. monocytogenes in the environment, it may be impossible to completely eliminate the organism from all foods. However, use of the sanitary practices and processing practices proposed in this document should prevent cross-contamination and growth of the organism in smoked and smoke-flavored seafoods. Smoking fish is a delicate process, involving a number of interrelated variables including times, temperatures, and exposure to smoke, salt, and sodium nitrite, when used. However, FDA believes that, by its very nature, this process involves certain inherent risks, risks that, if not attended to, can have very significant consequences. For example, the times/temperatures involved in the ``hot process'' can injure but not kill C. botulinum spores while killing spoilage microorganisms. Thus, during the period when the spoilage microorganisms are becoming reestablished, surviving C. botulinum spores would be presented with an optimum growth environment because of the lack of competition. Yet, because of the absence of spoilage microorganisms, spoilage odors that would warn consumers away from potentially dangerous products would not be present. Botulism toxin alone is not detectable by sensory examination. In addition, because of the number and types of steps involved, the processing of smoked fish involves an unusual amount of handling of the product relative to other seafood processing procedures. Increased handling presents increased opportunities for contamination during the process than would otherwise be the case. The finished product also is inherently more risky than most other seafood products because it is a ready-to-eat product that is generally not cooked before eating. However, the present evidence indicates that smoked fish has caused no more cases of botulism in the United States than any other type of seafood product. In contrast, fresh fillets that are not smoked are intended to be cooked before consumption. Cooking is lethal to bacteria and will deactivate botulism toxin. Thus, smoked fish products usually do not get the benefit of an additional processing step that protects against most bacteriological risks. In addition to these inherent characteristics, FDA believes that smoked fish present special risks because both domestic and foreign processors are now using vacuum packaging to a substantial extent--much more so than are other segments of the seafood industry. A 1988-1989 FDA and New York State survey of domestic processing plants, for example, showed that 45 percent of the firms visited vacuum-packaged smoked fish. However, there is no evidence to show a linkage between vacuum packaging of smoked fish and illness in the 5 years since this survey was completed. An economic incentive for use of vacuum packaging is the extended shelf-life of the product, made possible by the anaerobic environment in the package that prevents the growth of some spoilage microorganisms and slows the growth of others. Because this anaerobic environment cannot prevent spoilage altogether, vacuum-packaged products must still be refrigerated. Unfortunately, the anaerobic environment greatly favors the outgrowth of any C. botulinum spores that may be present over the development of telltale spoilage microorganisms. Thus, C. botulinum outgrowth can occur before spoilage if a vacuum-packaged product is temperature abused, i.e., not refrigerated. Moreover, as discussed elsewhere in this document, the growth of L. monocytogenes and C. botulinum type E and nonproteolytic type B is possible even at refrigeration temperatures below 40 deg.F (4.4 deg.C). FDA believes that strict controls are needed to overcome this risk. In 1970, FDA issued a final rule for smoked fish in response to outbreaks of botulism attributed to vacuum-packaged smoked fish products (35 FR 17401, November 13, 1970). Among other things, the rule attempted to control the risk of botulism by setting conservative processing parameters for time, temperature, and salinity that would minimize the opportunity for C. botulinum spore outgrowth. These parameters were based on the relatively limited research that had been conducted up to that time with one species of fish. Many processors claimed that these parameters would have resulted in a product that was too salty and too dry in texture to be marketable. The rule was overturned in court due to procedural problems (United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 1977)). However, in rethinking this rule after the remand, FDA decided that research was needed into the relationships among time, temperature, and salinity to develop processing parameters that would provide safety without producing an undesirable product that consumers would not buy. This research has been successfully conducted by FDA, the National Marine Fisheries Service, and the industry. FDA has prepared the time, temperature, and salinity parameters in the Hazard Assessment Guide based on the results of this research. 1. Need for Guidance FDA routinely inspects smoked fish processing establishments for sanitary conditions using the guidance in 21 CFR part 110, ``Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food'' (Ref. 196) and in the FDA Inspection Operations Manual, Chapter 5, Establishment Inspection and section 616.6 Smoked Fish inspection methods (Ref. 197). In addition to the Establishment Inspection Reports (EIR's) discussed in section G, EIR's for smoked fish processing establishments over the past few years (1985 to the present) show evidence that the use of manufacturing procedures are not in line with CGMP's. The EIR's also show that processing parameters and controlled processing and storage techniques, commonly recognized as appropriate in the industry (Ref. 182) are not being used (Ref. 169). Typical observations by FDA officials in these inspections include: (1) Live flies in production areas providing a vehicle for contamination and recontamination of products; (2) standing water in production rooms providing a medium for microbial growth and contamination from splashed water; (3) utensils not sanitized prior to use; (4) open bags of raw materials in storage areas exposing products to flying insects and potential microbial contamination; (5) smoke racks encrusted with pieces of fish from previous processes, thus providing an opportunity for microbial growth; (6) refrigerators being used for both raw and finished products, thus providing an environment for microbial growth through cross-contamination between unprocessed and processed products; (7) overcrowded fish in brine tanks, whereby some fish are not fully submerged in brine, resulting in lower and uneven levels of salt uptake that would not be effective in inhibiting spore outgrowth; (8) salinity and microbiologic testing not performed on products; (9) low minimum water-phase salt levels (0.88 to 1.79 percent) that would not inhibit C. botulinum spore outgrowth and toxin production; and (10) poor employee practices that foster microbial contamination, including spitting into sinks adjacent to sinks used to thaw product, not washing or sanitizing hands, and street clothes in contact with product (Ref. 169). (See also Ref. 200.) As part of its Fiscal Year (FY) 91 Domestic Fish and Fishery Products Inspection Assignment, FDA conducted food safety inspections of smoked fish establishments. These inspections revealed a continuing pattern of problems in these facilities. In over half of these inspections FDA found violations that required action, ranging from minor violations, which are normally handled by informing the firm's official during the inspection, to more serious violations that prompted some form of official agency action (Ref. 200). In addition, several States, working through AFDO, have expressed concern that a potential health hazard exists with smoked and smoke- flavored fish products and have stated that a Federal regulation is necessary for uniform regulation of the production and distribution of these foods (Refs. 170 and 189). AFDO is an organization of Federal, State, and local regulatory officials with membership representing all 50 states, as well as FDA and other Federal agencies. AFDO's Central States Regional organization held a meeting in 1988, attended by public health officials from 6 states in which the smoked fish industry is concentrated, Canada, and NMFS, to discuss a Federal regulation governing the processing, storage, and distribution of smoked and smoke-flavored fish products. In December, 1989, AFDO first passed a resolution requesting that FDA expedite the rulemaking process to establish uniform Federal regulations to ensure that safe smoked fish processing methods are utilized for fish products sold in the United States. In December, 1990, AFDO passed resolution 8, which strongly encouraged FDA to ``accelerate the promulgation of smoked fish CGMP's so that concerned States can move forward with their efforts to ensure the safety of smoked fish'' (Ref. 170). FDA recognizes the need to address the hazards associated with smoked and smoke-flavored fishery products and therefore is setting forth the procedures in Appendix 1 in the interest of protecting the public health. The need for some type of agency guidance on smoked fish is also evidenced by several other factors. First, the 1970 final rule, which covered only hot-process smoked and smoke-flavored fish and the processing parameters that they required, is still being used as a guideline by some States. These earlier parameters could result in commercially undesirable products. These parameters ought to be updated with the current technological understanding and processing flexibility for both hot and cold smoked products. The guidance in this document can provide the basis on which such updating can occur. Second, the manufacture or sale of cold-processed fish products is not permitted in at least two States because there are no regulations or regulatory guidelines for these products (Ref. 170). There is some pressure, however, to permit the sale of these products. The Canadian Government, for example, has urged these States, Minnesota and Michigan, to permit the sale of these products so that Canadian products may be exported to the United States (Ref. 170). Some type of guidance that helps to define the processing parameters and techniques that reduce human health risks from cold-process smoked and smoke- flavored fish products would provide State, as well as federal, public health officials with the tools necessary to evaluate the safety of cold processed products manufactured in the United States, as well as those imported into the United States. Third, in 1988 FDA conducted a survey of processing parameters used by fish smoking plants in the United States. Seventy five percent of the firms surveyed did not do final product testing to ascertain whether their products met commonly recognized (Ref. 182) parameters for their products (Ref. 24). The information collected in this survey augmented information obtained from the New York State Department of Agriculture and Marketing (Ref. 24), which had conducted a similar survey of fish smoking establishments in that State at approximately the same time. A total of 64 establishments were surveyed by FDA and New York State, representing over 90 percent of the smoked fish manufacturers in the United States. Among the species of fish included in the survey were chubs, bluefish, trout, carp, salmon, whitefish, and herring. Processing information was collected from manufacturers, and samples were collected for laboratory analysis. The following chart summarizes the results of these surveys and compares them to proposed processing parameters: 1988-1989 Domestic Survey Data -------------------------------------------------------------------------------------------------------------------------------------------------------- Characteristic FDA New York Proposal -------------------------------------------------------------------------------------------------------------------------------------------------------- Cold-Smoked Products: Temperature range....... 38 to 180 deg.F.............. 34 to 90 deg.F............... 50 deg.F for 24 hours or 90 deg.F for 20 hours. Water-phase salt........ 1.33 to 18.1 percent.......... 1.4 to 7.4 percent............ 2.5 to 3.5 percent.\1\ Nitrite range........... 3.75 to 994 ppm............... .............................. 100 to 200 ppm. Percentage of firms that 40 percent.................... 50 percent.................... .......................................................... do not know water-phase salt level. Hot-Smoked Products: Temperature range....... 90 to 210 deg.F.............. 128 to 240 deg.F............. 145 deg.F. Water-phase salt........ 0.88 to 27.5 percent.......... 1.3 to 7.0 percent............ 3.0 percent.\1\ Nitrite range........... 15 to 239 ppm................. .............................. .......................................................... Percentage of firms that 39 percent.................... 72 percent.................... .......................................................... do not know water-phase salt level. Total number of firms 76 percent.................... 74 percent.................... .......................................................... that do not test their products (for 1 or more processing parameter). -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\Actual level depends on other processing factors. Oven temperatures for hot processing ranged from 90 to 240 deg.F (32 to 116 deg.C) and from 38 to 125 deg.F (4.4 to 52 deg.C) for cold processing. Water-phase salt content in hot-process products ranged from 0.88 to 27.5 percent and in cold-process products from 1.33 to 18.1 percent. Twenty-eight firms (43.7 percent) vacuum packed cold- process products, but 60.7 percent of those firms did not test final products for water-phase salt content or for residual sodium nitrite. Twenty-five firms (39.1 percent) vacuum packed hot-process products, but 68 percent of those firms did not test final products for water- phase salt content or for residual sodium nitrite. Seventy-five percent of the firms surveyed did not test final products for water-phase salt content or for residual sodium nitrite, where used. Since this survey was conducted, the frequency of FDA inspections of smoked fish establishments has been increased over 50 percent each year. Therefore, FDA is providing guidance on the appropriate parameters for processing smoked fishery products in Appendix 1 to this document. The guidance addresses critical control points that apply to these products as a class and that will typically be identified in the HACCP plans of most processors of smoke and smoke-flavored products. The guidance also addresses ways of controlling hazards at these critical control points. The key processing parameters that must be controlled to ensure the safety of these products involve time, temperature, and salinity. While a range of time-temperature-salinity (TTS) values will provide a safe product, there are now known safety minimums for these values that have been developed through years of research. Processors whose TTS values fall below these minimums do not produce a safe product and shift much of the burden of preventing botulism toxin outgrowth to those who take possession of these products after they leave the processing plant, including the ultimate consumer. This burden includes, among other things, maintaining strict temperature control at 40 deg.F or lower even though it is known that many commercial and home refrigerators are unable to maintain this temperature (Ref. 201). These TTS minimums are known to produce a marketable product, because there are processors that operate in conformance with them. Moreover, because they are minimums, these values allow for the production of a variety of products, such as different types of lox with varying amounts of saltiness, to suit different tastes. These minimum TTS values provide the only scientifically valid way developed to date of ensuring that no botulism toxin will be produced over the shelf life of the product under proper refrigeration conditions or under conditions of moderate temperature abuse. The minimum values, coupled with the sanitation practices proposed in this document, should also ensure against the presence of detectable L. monocytogenes. These minimum TTS values are being issued at this time as proposed guidance to ensure maximum flexibility. If these values are reflected in the HACCP plans that are required by proposed subpart A of 21 CFR part 123, and are being effectively implemented by the processor, the agency is likely to find that the plan and its implementation are adequate with regard to those critical limits and critical control points. The same holds true for the other types of controls recommended in the guidance. The agency is requesting comment on this approach, and on the following alternatives: (1) Issue all or part of the materials relating to smoked and smoke-flavored fishery products in Appendix 1 as regulations, rather than guidance. Given the public health concerns associated with these products and the scientific basis for the TTS minimums, it may well be appropriate to issue them as regulations. Such regulations would take into account advances in knowledge and technology by allowing processors to use alternative processing parameters so long as these alternatives were scientifically demonstrated to produce an equivalent level of safety. (Section 11 of the guidance relating to smoked and smoke-flavored fishery products in Appendix 1 contains such a feature.) (2) Issue a performance standard as a regulation, while leaving the materials in Appendix 1 as guidelines on how processors could meet the performance standard. The likely performance standard would be, as suggested above (and included in section 11 of the guidance relating to smoked and smoke- flavored fishery products in Appendix 1): (a) for botulism, zero toxin production in the product during a time period through--and slightly beyond--the shelf life of the product, demonstrated through inoculated pack studies under normal and moderate abuse conditions; and (b) no detectable L. monocytogenes in the final product. (3) Maintain the guidance relating to smoked and smoke-flavored fishery products in the FDA Fish and Fishery Products Hazards and Controls Guide and control safety through the HACCP requirements for all seafood in proposed subpart A. FDA requests comment on which of these alternatives is most likely to ensure that smoked fish will be safe and is most consistent with the agency's obligations under the act. In the absence of a regulation or guideline, how can the agency best ensure that the results of the research that it has conducted will be available for use by the industry? FDA solicits comments on these and the matters raised above. N. Verification Issues As described in section IV.A. of this document, one of the NACMCF's seven HACCP principles involves verification that the HACCP system is working. NACMCF recommends that HACCP plans include procedures for verification of the HACCP system (Ref. 34, p. 200). FDA advises processors to consider adopting this recommendation, but has not proposed to require it because the agency expects verification to occur through: (1) A firm's consistency with the controls and limits to be provided by FDA in the HACCP guidance described in section VII.C. and M. of this document; (2) third-party technical assistance provided through trade associations, universities and government agencies; and (3) review of all HACCP monitoring records by trained individuals before distribution of product (see proposed Sec. 123.8(b)); the proposed corrective action requirements (see proposed Sec. 123.7), especially the provision for assessment of HACCP plans as a consequence of deviations (Sec. 123.7(a)(4)); the recommended use of process authorities for cooked, ready-to-eat products (see Appendix A); the proposed general training requirements (see proposed Sec. 123.9); and inspector review during routine agency inspections. FDA invites comment on whether this approach is adequate to ensure that the NACMCF verification principle is being properly addressed, both for individual firms and for the overall HACCP program. For individual firms, NACMCF specifically discourages the sole reliance on end-product sampling for verification purposes (Ref. 34, p. 201). FDA also has questions concerning the efficacy of end-product sampling as the only way to measure the success of HACCP. These caveats notwithstanding, FDA invites comment on what tests should be used to measure success, both in terms of individual firms and the program as a whole, and how frequently such tests should be administered. VIII. Other Approaches to HACCP This preamble has described in great detail the HACCP system that is being proposed and the reasoning behind each proposed provision. While the agency is inviting comment on the merits of each provision, FDA also invites comment on the overall system, including whether some other approach to HACCP or some variation of the proposed approach might be preferable. Variations on the proposed approach include, but are not limited to: (1) Requiring HACCP only for higher risk seafood products; (2) exempting small firms from HACCP requirements; (3) staggering the effective date for implementation based on size of firm or risk; and (4) deleting or altering some of the requirements in this proposal in order to facilitate implementation and lower costs. A brief discussion of each of these variations follows: A. Higher Risk Only An alternative to requiring HACCP for all commercial seafood products would be to require it for products or processes that have been linked to significant numbers reported seafood-borne illnesses. As section II.B. of this document explains in detail, many of the reported illnesses from seafood involve raw molluscan shellfish and certain species of finfish that can accumulate scombrotoxin and ciguatoxin. Other seafood products cause illness but are not as commonly reported. FDA invites comment on whether this proposed regulation should apply only to molluscan shellfish and the species responsible for scombrotoxin and ciguatoxin poisonings. A variation on this approach would be to have the proposed regulation apply to those species and processes with a higher potential for harm, even if actual illnesses from them cannot be documented from the foodborne illness reporting system. As described earlier in the preamble, the fact that the system is not recording illnesses from a particular food does not mean that illnesses are not occurring. Also, potential for harm need not always be measured in terms of the number of illnesses that are actually occurring. For example, some problems, like botulism, may occur infrequently, but when they do, the consequences can be devastating. Based on the potential for harm, other candidates for inclusion would be: (1) Hot-process smoked and hot- process smoke-flavored fish, cold-process smoked and cold-process smoke- flavored fish, because of the hazards of botulism and listeria; (2) cooked, ready-to-eat products, because of the microbiological hazards associated with products that are not intended to be cooked by the consumer; (3) low acid canned foods, because of the hazard of botulism and general complexity of the processing operation; (4) raw, ready-to-eat products, because of the risk of parasites; and (5) species that require a judgment as to appropriate location of harvest to avoid unsafe pesticide or industrial contaminant levels. FDA also invites comment on the effect of using a modified approach on the regulation of imports, especially with regard to the types of products described in item (5) above. B. Exempting Small Firms FDA invites comment on whether small firms should be exempt from the proposed regulation. Even if exempted, these firms would still be subject to the requirements of current food safety law and to inspection by FDA and State authorities. As stated earlier in this preamble, small operations are the norm in the seafood industry. A significant majority of processors have total revenues of under 1 million dollars. If small firms are to be exempted, FDA invites comment on the criteria that should be used for exempting them, including how a small firm should be defined for purposes of an exemption. The implementation of HACCP may be more burdensome for small firms than for large firms. Large firms tend to have quality control personnel already in place. In addition, many regulatory requirements are less burdensome for a large firm in proportion to output than they are for a small firm. On the other hand, FDA is taking steps, such as the preparation of its HACCP guidance, to minimize the cost of these regulations for small businesses. Thus, such an exemption may not be needed. The agency also points out that, because many large firms already have quality control systems, an exemption for small business would appear to result in requiring HACCP for that segment of the industry (i.e., large firms) that needs it the least. Large processors, moreover, tend to process relatively low risk products, such as breaded fish and shrimp and raw fish blocks. Many high-risk processors, such as processors of cooked, ready-to-eat products, tend to be small, and processors of raw molluscan shellfish tend to be very small. Nonetheless, an exemption for small business could be limited to those small businesses that produce low risk products, and FDA invites comment on this approach. As stated earlier, however, the criteria for determining low as well as high risk are not clear, due largely to the limitations of the U.S. foodborne illness reporting system. Moreover, a case can be made that risk also relates to the margin for error in a processing operation and to the consequences of failure as well as to the actual occurrence of illness. With these points in mind, FDA invites comment on how to define ``low risk.'' FDA also invites comment on what the nature of the exemption should be. Should a firm be exempt from all or part of the HACCP requirements? As circumstances change, a HACCP-based analysis of risk by a firm might reveal that the firm has become a high risk processor rather than a low risk processor. In addition, FDA invites comment on whether such an exemption should be obtained by petitioning the agency. Finally, even if an exemption were to be adopted in the final rule based on the comments received, the agency would still encourage voluntary adoption of HACCP systems by exempted firms. The advantages that HACCP is expected to provide in terms of consumer confidence, control of process, and access to international markets warrant adoption of this system. FDA also invites comment on the effect of a small business exemption on the regulation of imports. How would HACCP be applied to imports under a tiered approach? Would it be possible to treat domestic and imported products equally under such an approach? C. Staggered Phase-in The proposed regulations include an effective date of 1 year from the publication of a final rule. FDA has explained the reasoning behind this proposed effective date and has invited comment on it elsewhere in this preamble. In addition, comments are invited on the merits of a staggered phase-in instead of a single implementation date for all affected entities. The two most obvious ways of accomplishing a staggered phase-in would be to differentiate on the basis of size or on the basis of risk. Differentiating on the basis of size would presumably allow small businesses to have a longer time or times for implementation than would be allowed for larger firms. As suggested earlier, large firms are probably much more able to implement a HACCP system than are small firms. Theoretically, the longer lead time for small firms would allow the private sector to develop an infrastructure that could help small firms implement HACCP. Such an infrastructure could include process authorities (see the preamble discussion on cooked, ready-to-eat products), testing facilities, and consulting services from trade associations, academia, and others. As an additional consideration, FDA will likely learn lessons from its experiences in implementing the regulation that it could apply to the benefit of those that would have to implement it at a later date. For example, FDA is considering whether it should make the first review of HACCP plans by agency investigators a nonregulatory evaluation to facilitate plan development by the processor (although the overall inspection of the plant would be regulatory). The agency invites comment on this approach. Presumably, the more experience the agency has, the better this evaluation will be. On the other hand, as noted above, small firms are involved in the processing of higher risk products. How does this fact bear on the possibility of longer implementation times for small firms? Differentiation solely on the basis of risk appears to be more complex than differentiation on the basis of size. If high risk products were to be phased in first, it would appear that those with the most complex plans to develop and implement would receive the shortest lead time, while those with the simplest plans would receive the longest lead time. Also, the criteria for determining risk would have to be carefully considered. FDA asks for comment on whether a staggered start should begin with raw molluscan shellfish and certain species of finfish that can accumulate scombrotoxin and ciguatoxin, or whether other criteria should apply, as discussed previously. FDA invites comment on all these matters. FDA also invites comment on the effect of a phase-in approach on the regulation of imports. How could this approach be applied to imported products? D. Deleting or Modifying Aspects of This Proposal, or Taking Some Other Step, to Reduce the Burden of Implementation As has already been explained in this preamble, FDA has proposed only the basics of HACCP in order to keep the regulatory burden to a minimum. Several features of HACCP included within the NACMCF's seven principles, such as flow charts and the establishment of ``HACCP teams,'' are noted in this preamble, but FDA has not proposed to require them. Nonetheless, FDA acknowledges that, theoretically, there are a number of ways in which this proposal could be scaled back even further. FDA invites comments on whether such scaling back would be desirable, and, if so, how it could be done. Possible areas for scale- back include, but are not limited to: (1) Requiring only negative, rather than positive records. Negative records note only deviations from critical limits and how they are corrected. If a critical control point is under control, no record is made. Admittedly, FDA has reservations about such an approach. For example, it is virtually impossible for firms or for FDA to spot trends that could lead to problems if only negative records are being kept. Nonetheless, FDA invites comment on this approach. (2) Developing generic plans by FDA that list critical control points and contain other information for various industry segments. (3) Deleting some or all of the proposed specific sanitation requirements. (4) Requiring HACCP only for the domestic industry. The HACCP requirements would become the basis for negotiating agreements with other countries relating to the equivalency of regulatory programs. (5) Deleting or modifying the proposed training requirements. (6) Requiring HACCP for processing hazards only. The Canadian HACCP system does not involve species-related safety hazards. (7) Exempting warehouses. (8) Although only in guidelines (Appendix B, Scombroid Toxin- Forming Species), sanctioning the receipt by a processor from a harvester of an assurance of good handling practices, rather than detailed time/temperature records. Such an assurance, without further verification, would be acceptable only from harvesters with histories of delivering acceptable products. These four alternative approaches to implementing these regulations are not necessarily mutually exclusive. Comments are invited on them in combination as well as on them individually. E. Information and Consumer Awareness In addition to requesting comment on alternative approaches to HACCP, FDA is taking the opportunity to invite comment on the general subject of complementary risk reduction activities, primarily directed toward postprocessing handling. Elsewhere in this document, FDA invited comment on the advisability of applying HACCP or alternative regulatory approaches to commercial entities that are not directly subject to these proposed regulations, i.e., harvesting vessels, common carriers, and retail establishments (although not necessarily doing so as part of this rulemaking). In addition, FDA seeks comment on appropriate education and information that should be directed toward consumers and recreational fishermen. The commercial application of HACCP principles can mitigate somewhat the effects of poor consumer handling practices by helping to ensure that a safe product reaches the home, but no such program can prevent illnesses caused by improper home handling. Similarly, HACCP practiced by processors can have no effect on recreational fishermen who consume their own catch. Education has always been an important part of FDA's comprehensive seafood safety program, but the agency believes that more can be done. Recent FDA education projects include the initiation of a seafood hotline, which has been consulted by over 26,000 individuals on a wide range of seafood safety issues since it began in October 1992. (The hotline can be reached by calling toll-free, 1-800-FDA-4010.) FDA also recently developed brochures aimed at advising certain medically compromised populations that they should not eat molluscan shellfish without adequate cooking. FDA invites comment on other types of education and information activities that might be useful, including more information that might be made available through grocery stores, pharmacies, and other establishments, through the media, and through other means, including labeling. FDA is considering the merits of labeling information for consumers of molluscan shellfish, and will address this issue in proceedings separate from these regulations. FDA notes that several states have already mandated, or are in the process of mandating, point- of-purchase information for raw molluscan shellfish. The agency also invites comment on whether FDA should consider proposing to require handling instructions for consumers on the labeling of seafood. The Department of Agriculture has proposed such requirements for meat and poultry (58 FR 58922, November 4, 1993). FDA has a longstanding program to control the levels of microorganisms of public health concern in seafood. This program includes compliance policies on such levels, including zero levels (i.e., none detectable based upon official methods) for such pathogens as Listeria monocytogenes in cooked, ready-to-eat products and Salmonella in all foods. These proposed regulations require control of microbial pathogens through HACCP principles, including specific sanitation controls. Even so, FDA recognizes that no system can reduce all risks to zero. Because all foods in the home, including seafood, are subject to mishandling and cross contamination from other sources, FDA invites comment on the general subject of handling instructions. Should FDA decide to propose handling instructions, it would do so as a regulatory proposal separate from the proposed HACCP requirements for seafood. IX. Paperwork Reduction Act This proposed rule contains requirements for information collections which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980. The title, description, and respondent description of the information collection are shown below with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Title: Procedures for the Safe Processing and Importing of Fish and Fishery Products. Description: The information requirements in this proposed rule are essentially monitoring and recordkeeping requirements encompassing critical control points in the production and inspection of fish and fishery products as established in the HACCP plans of processors and importers. The specific information collected and the frequency of collection will depend on such factors as the species and the processing conditions. It will include observations of processing parameters such as the time and temperature of processing and storage; the condition of raw materials; the results of chemical and microbiological tests; the sanitation conditions in a processing facility; the corrective actions taken in response to processing deviations, etc. Records identifying production lot codes and date of manufacture will also be maintained. Records will be maintained by the processing facility or at an importer's place of business for 1 year after the date of preparation in the case of refrigerated products and at least 2 years for frozen products. This information will be used by FDA investigators during regularly scheduled inspections of processing plants, or at the time of entry of imports, to determine whether products were processed under sanitary conditions and processed, packaged, stored, and distributed using HACCP control techniques to avoid hazards that might cause the products to be adulterated. The information will also be used when necessary to trace and remove potentially hazardous products from the marketplace. Records of processing conditions will also provide a means for processors to monitor the quality of their products and to alert them when a deviation from the critical limits established in the HACCP plan has occurred that may create a potential public health hazard in the final product. The figures provided below reflect an FDA estimate of the annual hours of monitoring and recordkeeping based upon currently available data and assumptions about the effects of the requirements in proposed part 123. The estimate is based on data used to develop cost estimates for the economic impact analysis required by Executive Order 12866 and thus is subject to the same types of uncertainties described elsewhere in this preamble. For example, the agency has anecdotal evidence that the burden on firms that are operating under a mandatory HACCP system established by the State of Alaska is more nominal. Consequently, FDA acknowledges the possibility that the estimates provided here are conservatively high, indicating recordkeeping burdens that are higher than would customarily be the case. FDA specifically invites comments on this point. Description of Respondents: Businesses. Estimated Annual Reporting and Recordkeeping Burden ------------------------------------------------------------------------ Average annual burden Number of respondents per respondent Total burden all (hours) respondents (hours) ------------------------------------------------------------------------ 4,349................. 650 2,826,850 ------------------------------------------------------------------------ The agency has submitted a copy of this proposed rule to OMB for its review of this information collection. Interested persons are requested to send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to FDA's Dockets Management Branch (address above), and to the Office of Information and Regulatory Affairs, OMB rm. 3208, New Executive Office Bldg., Washington, DC 20503, Attn: Desk Officer for FDA. X. Economic Impact FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866 compels agencies to use cost-benefit analysis as a component of decisionmaking. The Regulatory Flexibility Act requires regulatory relief for small businesses where feasible. FDA finds that this proposed rule constitutes a major rule under both Executive Order 12866 and the Regulatory Flexibility Act. A summary of the preliminary regulatory impact analysis (PRIA), which may be obtained from Dockets Management Branch (address above), is presented below. Executive Order 12866 requires Federal agencies to justify the need for regulations by demonstrating that the problem that the regulation is designed to remedy cannot be adequately addressed by measures other than Federal regulation. In its review of such alternatives, FDA finds that the current system (periodic inspection plus sampling of a small proportion of seafood), coupled with the uncertainty in estimating the illnesses related to seafood, has not adequately ensured consumers that a minimum level of safety has been established. Although the tort system is not able to provide remedies for unsafe seafood, the price system provides some differentiation between products based on brands and retail reputation. However, the price system works in conjunction with current Federal regulation which signals consumers as to a minimum level of seafood safety. As is argued in the preamble, countless public arguments and attempts at legislation imply that the minimum levels that some consumers believe they are getting (those that do not search for higher levels) is probably higher than the actual levels of seafood safety. The tort system fails because consumers are often unable to trace either the source of their foodborne illness to seafood, and even where that is possible, it is often difficult to trace seafood to a specific company. A. Regulatory Options FDA has evaluated multiple options to address the compelling public interest in further ensuring seafood safety. These options include: (1) Maintaining the existing approach--``snapshot'' inspections and sampling; (2) significantly increasing the frequency of both snapshot inspections and sampling under the existing approach; (3) beginning a voluntary HACCP program in addition to the existing approach; (4) beginning mandatory HACCP for high risk products only, in addition to the existing approach; (5) beginning mandatory HACCP for all seafood (the proposed approach); (6) beginning a more comprehensive mandatory HACCP program than that proposed, similar to the Model Seafood Surveillance Project (MSSP), which would include all CGMP's, quality factors, and economic fraud as critical control points; and (7) beginning a mandatory water-to-table HACCP program which would include all vessels, carriers, and retail food operators. The existing approach does not adequately address the compelling public interest in further ensuring seafood safety because sampling the large volume of seafood with FDA's limited resources cannot detect many violative products. Increasing the frequency of sampling and inspections is also unlikely to resolve this problem without significant increases in funding. These options are discussed extensively in the preamble to the proposed regulations and in the PRIA. The third option, voluntary HACCP, has been in existence at NOAA and has very few participants. The forth option, risk-based HACCP, has been evaluated in the PRIA in several forms, including HACCP only for the highest risk products from a historical perspective and HACCP only for those products with the potential for catastrophic risk. For example, one possibility evaluated under this option would be to implement HACCP solely for molluscan shellfish, which NAS and other groups have concluded constitute most of the risk from seafood. The sixth option is more costly than the proposed option and includes more reliance on CGMP's. Finally, the last option involves mandatory HACCP for nearly 1 million establishments. The options evaluated in the PRIA have both lower and higher costs than the proposed option. However, the benefits of all options are not equal to the proposed option. FDA has quantified net benefits of some of the high risk options and has found them to have been positive net benefits for those costs and benefits which have been quantified. These options are not all equal in terms of costs and benefits. They differ significantly from one another in this regard, as well as from the option that FDA has selected to propose as new part 123. They are also not equal in their ability to meet all the regulatory objectives stated in the preamble, including effective treatment of imports and an appropriate alignment of industry and government responsibilities. FDA seeks comment on the costs and benefits as well as on the general pros and cons of all the stated options and on any options that the agency may have overlooked. It is extremely important that FDA's evaluation of regulatory options be as thorough as possible for purposes of developing a final rule, and that the agency be able to fully articulate the distinctions among them and the significance of those distinctions. B. Costs There is no single source of data that FDA has found to be entirely satisfactory for developing a preliminary estimate of the costs of the proposed regulations. Consequently, FDA has considered two sources of information, each with its own strengths and weaknesses. The results provide a range of possibilities, and FDA invites comment on them. The first source is U.S. seafood processors that have actually implemented HACCP systems. The number of such firms may exceed 100. Understandably, many firms are reluctant to make public detailed information about the costs of operation; consequently, the information available to FDA from this source is incomplete. On the other hand, there is enough information from which some preliminary conclusions can be drawn that are relevant to an economic assessment. The second source is a study of the costs of implementing a form of HACCP that was developed by the Department of Commerce for the congressionally mandated MSSP. That study was performed by an independent contractor for the National Fisheries Education and Research Foundation, Inc., and commissioned under a grant from NMFS. While these data are the most detailed available, fitting them to the proposed regulations required extensive adjustments and extrapolations. Thus, these data also fail to eliminate the considerable uncertainty of the results as they relate to these proposed regulations. 1. Costs: Actual Industry Experience FDA has some information relevant to the actual costs of implementing HACCP experienced by a number of seafood firms. While this information is neither detailed nor complete enough to definitively answer the question of how much the proposed regulations will cost the industry, it does provide insight into the costs of the proposed regulations. This information includes responses to a 1991 evaluation questionnaire from four of the eight firms that participated in the FDA/NOAA seafood HACCP pilot in 1990-1991 (Ref. 40). It also includes information more recently provided to FDA from seven firms through the assistance of NFPA, and from two trade associations. The trade associations, the NFI and the New England Fisheries Development Association (NEFDA) provided FDA with summary information about member firms that were implementing HACCP systems. NEFDA has operated a HACCP pilot with member firms through a Federal grant. The two trade associations provided information on 16 firms. The seven firms that provided information about themselves through NFPA operate a total of 44 processing plants, so FDA has information on at least 64 plants (Ref. 129). The firms represent a good cross section of processing operation types, including canned, fresh, frozen, smoked/salted, and cooked, ready-to-eat products as well as molluscan shellfish. The majority of firms were involved in HACCP as participants in either pilot programs, the NOAA fee-for-service program, or the State of Alaska program, and therefore have been subject to some form of third party verification of their HACCP systems. Virtually all of them developed HACCP plans, and the majority of these included critical control points for quality or economic fraud or both in addition to safety. In this respect, the majority of firms implemented a more extensive form of HACCP than is being proposed by FDA. Presumably, start-up costs for HACCP are normally higher than operating costs in subsequent years. The majority of firms that could estimate their own start-up costs indicated costs in the $1,000 to $5,000 range. The remaining minority appear to be roughly equally divided between lower and higher costs. A few firms indicated costs in the $20,000 or higher range. These may be firms that decided to hire additional personnel in order to install or implement HACCP. It should be noted that the cost figures that come from firms that operate more than one plant are for the total costs of their plants collectively; in order to calculate the average start-up cost per plant for these firms, their costs would have to be divided by the number of plants. Nearly twice as many firms did not hire additional personnel or did not anticipate hiring additional personnel as a result of operating HACCP systems as those who did or felt the need to do so. The overwhelming majority of firms reported that they believed that the advantages they derived from HACCP were worth the costs to them in terms of better control over their operations, better sanitation, and greater efficiencies, such as reduced waste. Virtually all foresaw long-term benefits from operating under HACCP. FDA notes that there are several uncertainties with this data. The first is that FDA does not know the extent of previous HACCP-type activities in these firms so that they may have different incremental costs than the industry average. In addition, these firms may have been relatively larger firms so that they may not be fully representative of the industry. Also, FDA does not know whether or not these firms would necessarily be in full compliance with the proposed regulations so that additional costs might have to be expended. 2. Costs: MSSP Study The MSSP study provides FDA with survey data from which detailed cost estimates have been made in the PRIA, subject to numerous uncertainties. As this is the largest and only randomly selected data base available to FDA, the PRIA relied primarily on estimates based on these data. The contractor in the MSSP study sent teams into 130 processing plants, none of which were operating under HACCP systems, to project the costs to each plant to implement and operate a form of HACCP chosen for that study. In areas where FDA had better data than that used in the contractor reports, the agency has used information available from its field surveys on current practices or conditions in the industry in general, and it has substituted that information for the information gathered from the sample plants in the contractor reports. Where gaps in the contractor estimates exist that could not be filled in by information from FDA field surveys, a number of assumptions have been made for the purposes of this economic assessment. FDA views the cost estimates extrapolated from the contractor reports and other sources as preliminary and requests comments on them. From FDA's 1992 official establishment inventory, FDA has estimated that there are 4,846 domestic seafood manufacturing plants that will be affected by the proposed rule. Thirty-three percent of the first year costs can be attributed to expenditures necessary to comply with the HACCP-based sanitation provisions of the proposed rule. Another 36 percent are attributable to monitoring and recordkeeping requirements. In addition, approximately 31 percent of the first year costs are for equipment such as temperature indicators, temperature recorders, and can seam tear-down machines. Additional costs are for HACCP training, consulting by processing authorities, writing HACCP plans, instituting operational changes, responding to critical limit deviations, and analytical testing. The average expected cost of the proposed rule per domestic manufacturing plant is estimated to be $23,900 in the first year ($24,000 for small plants, $23,400 for large plants) and $15,000 in the following years ($14,700 for small plants and $15,700 for large plants). Total costs of the proposed rule for domestic manufacturers are estimated to be $117 million in the first year and $65 million in the following years. In addition, FDA estimates that 924 importers will bear start-up costs of approximately $8 million, and 1,571 repackers and warehouses will bear annual recurring costs of $14 million. Therefore, based on these data, FDA estimates domestic costs for this rule to be $139 million in the first year and $79 million in succeeding years. Discounted domestic costs are estimated to be $676 million over 10 years (6 percent). FDA also estimates that 8,125 foreign processors will have initial costs of $96 million and recurring costs of $44 million. Should smoked fish products be required to bear refrigeration statements on their labels, the maximum possible cost to this industry segment would be estimated to be $2.5 million for a label redesign for all products. A label redesign would be likely only in the case of extensive refrigeration instructions. If a simple statement such as ``keep refrigerated'' were to be required, then the cost to the smoked fish industry would be approximately $168,000 because approximately 75 percent of the products currently bear such statements. These estimates are considerably higher than the estimates from data submitted to FDA from seafood plants as discussed above. These differences may be attributable to several factors. For example, the MSSP-based estimates also include estimated costs of compliance by processors with pre-existing sanitation requirements in part 110 and costs of complying with guidelines that are appended to these proposed regulations. Although these costs are not inherent to the operation of a HACCP system, they represent one-third of the total MSSP-based estimates. As indicated earlier in this document, compliance with CGMP's for sanitation has been a continuing problem across the industry. For this reason, FDA is proposing specific sanitation requirements in subpart A of part 123. Moreover, the estimate of costs associated with complying with guidelines in the appendices may be overstated because, in actuality, FDA may find industry practices other than those stated in the guidelines to be acceptable. The guidelines are intended to provide the industry with information on how it could implement HACCP, not how it must do so. Costs to importers and to foreign processors that ship to the United States were also estimated. In the absence of reliable data for estimating costs to foreign processors, FDA estimated the number of plants that export seafood to the United States and based their costs of implementing HACCP on MSSP- generated data on the costs to U.S. plants. It is important to recognize that many of the United States major seafood trading partners are using, or have opted for, HACCP programs. For example, the EC will soon require HACCP or an equivalent system from over 100 nations that export to it. Consequently, with the current trend toward HACCP worldwide, the costs to many foreign processors of implementing HACCP may be incurred regardless of whether FDA issued these proposed regulations. Moreover, in the near future, U.S. importers subject to this proposed rule should have little difficulty finding products produced under HACCP. FDA specifically invites comment on the estimated costs of the proposed regulations to importers and foreign processors, e.g., whether they are high due to the worldwide move toward HACCP or whether they are low due to other factors that have not been considered, and the potential effect on U.S. consumers of requiring that imports be produced under HACCP systems. The PRIA presumes that most of the cost of compliance of the proposed regulations will be passed on to consumers. Estimating the magnitude of these price increases is difficult. U.S. consumers spent about $16.5 billion on domestically produced seafood in 1991 (Ref. 42). If the domestic industry passed on all of the estimated annual costs to consumers, prices for domestically produced seafood would increase by less than 1 percent in the first year and less than one-half of 1 percent in succeeding years. Price changes of such magnitude are unlikely to have a major impact on general seafood purchases. However, some regional price increases may considerably exceed this. In addition, this estimation of change in price does not address potential concentration effects. It is worth noting that the contractor that performed the MSSP study estimated a range of cost increases from negligible to 1.3 percent, depending on the type of product. The effect on prices of imported products is impossible to estimate. While the PRIA uses MSSP data and a number of assumptions to estimate possible costs to foreign processors of complying with the proposed regulations, those costs will be spread among the consumers from all nations to which these processors export. FDA is unable to estimate what percentage of these costs would be passed on to U.S. consumers. On the other side of the ledger, the MSSP-based estimates were not able to include costs associated with some features of the proposed rules because data were lacking. An inventory of these features is provided in the PRIA, and FDA invites comment on possible costs associated with them. They include prevention of cross contamination by the separation of food contact surfaces, storage at 40 deg.F of cooked, ready-to-eat products and products that are made in whole or in part of scombroid toxin forming species, and the costs of following the approach presented in the guidelines at Appendix B for scombroid toxin forming species. C. Benefits This proposed action will reduce the amount of illness that derives from consumption of seafood (safety benefits) and may have significant nutrition benefits that result from increased consumption of seafood. The increased consumption will result from a decrease in consumer anxiety associated with the consumption of seafood. In addition, there may be significant cost savings (benefits) in other areas as a result of adoption of this proposed rule. The existence of a national, mandatory, HACCP-based inspection system for seafood should have a beneficial, although nonquantifiable effect on both the industry and the Federal government. FDA knows from experience that continuing concerns about the adequacy of the current Federal regulatory system for seafood place a financial stress on industry, which must constantly defend itself from criticism, and on regulatory agencies such as FDA, which must divert resources in order to respond to the Congress and the media. While public interest in food safety is healthy and desirable, the extreme interest in seafood safety, which has manifested itself in over 10 congressional hearings and over 20 pieces of legislation in the past 5 years, demonstrates how a system that is less than fully adequate from the public's standpoint can cause a steady diversion of both public and private resources that is likely to continue in the absence of a system that overcomes current inefficiencies and shortcomings. Finally, there will be an additional benefit to firms wishing to export seafood to those countries which require federally monitored HACCP. The latter two benefits have not been quantified, and FDA requests comments on how this might be done. The agency followed three steps to quantify the safety benefits of HACCP for processors: (1) Identify all significant hazards associated with seafood safety and establish the baseline number of incidents of each hazard in the U.S. population; (2) estimate the reduction in the number of incidents of each hazard that HACCP is expected to accomplish; and (3) quantify the benefit of the reduced illnesses and deaths. In all three steps, FDA acknowledges that there is substantial uncertainty. First, to establish a baseline number of illnesses, FDA reviewed both reported data to the CDCP, which provides a lower bound on the actual number of cases, and an earlier FDA risk assessment that estimated an upper-bound number of cases. Using information about the probable amount of underreporting for each type of illness, FDA constructed a likely baseline number for each type of illness by inflating these numbers between zero and 1,000 times the amount reported. Thus, for example, while it is likely that nearly all cases of neurotoxic shellfish poisoning (NSP) are reported to CDCP, it is likely that Campylobacter jejuni is underreported by approximately 100 times the actual number of cases. This approach for estimating cases yielded an estimated 33,000 cases of illness from seafood per year. However, FDA acknowledges that even a reasonably precise estimate of the number of illnesses cannot be determined with the existing foodborne disease reporting mechanisms in this country. In the second step, FDA used a panel of internal experts to determine the number of illnesses the proposed regulations are likely to reduce.\1\ For example, it is not likely to reduce any cases of NSP because they are primarily associated with recreational fishing. On the other hand, it is likely to reduce over 50 percent of scombroid poisoning because most of the mishandling of seafood comes either at the catch or processing stages. This action will not reduce any cases that are a result of consumer or retailer mishandling but, as explained earlier in this document, problems at the retail level are addressed through mechanisms outside of this proposed regulation. FDA has estimated that between 5,000 and 19,000 cases of seafood illness and death will be reduced by the proposed action annually. --------------------------------------------------------------------------- \1\Memorandum to Richard A. Williams, Jr., November 17, 1993. --------------------------------------------------------------------------- In the third step, FDA used economic valuation techniques to quantify the effect of reducing the range of cases of seafood illness. This technique combines costs of illness, such as hospital costs, with the costs of pain and suffering in a reduced health state to estimate the cost of each hazard. Thus, for example, NSP, with very mild symptoms, has a low cost per case ($270), whereas Vibrio vulnificus, with a high probability of death, has a very high cost ($1.3 million per case). Using this methodology, the total safety benefits of the proposed option are valued between $15 and $75 million per year. FDA has also evaluated the potential health benefits associated with increased consumption of seafood. Because of the negative publicity concerning water pollution and seafood safety, consumer perception of seafood safety may overestimate actual risk. In addition, contamination scares cause drastic short-term drops in consumer demand for seafood products and undoubtedly contribute to the chronic level of consumer concern about seafood safety. Thus, safety concerns about seafood are a likely factor preventing wider consumer acceptance of seafood as part of the U.S. diet. If this proposal is finalized, consumer concerns about seafood safety may be reduced which may, in turn, lead to increased consumption of seafood. FDA has evaluated the possibility that consumers may switch from higher fat flesh protein, such as meat and poultry, to seafood. The resulting reduced dietary fat in the diet of the general population would result in reduced incidence of coronary heart disease and cancer. Using the same methodology employed in an earlier analysis of the Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535), FDA analyzed the benefits of a 1- and 5-pound per capita increase in consumption of seafood. These were estimated to decrease deaths by 673 and 2,782, respectively, over a 10-year period. The resulting benefits are valued at $3 and $14 billion. D. Small Business Impact The proposed rule will have a substantial impact on small seafood processors as defined by the Regulatory Flexibility Act. Eighty percent of the seafood processors covered by this proposed regulation are small, where small is defined for nonshrimp firms as less than $1 million in annual gross revenue and less than $2 million for shrimp firms. The provisions of this rule, such as monitoring and recordkeeping, are largely fixed costs (costs which do not vary significantly with the amount of the product produced) which will impose larger per unit costs on small rather than on large businesses. In addition, small firms may have as many critical control points as large firms because critical control points tend to be related to the complexity of the operation, not the size of the business. However, it may be that smaller firms are less complex than large firms, although the agency does not have sufficient data to determine if this is so. In some cases the increase in cost will be large enough to cause some firms to go out of business. For example, estimates of firm failure have been as low as 2 percent (96 firms) of all firms (from the Canadian experience) to 334 firms (estimated for compliance with MSSP). However, FDA does not have enough information to estimate the number of firms that will close if the proposed rule becomes final. There are several factors that affect the ability of small processors to comply with the proposed regulations. First, the basic HACCP requirements proposed in subpart A of part 123 deliberately include only the essentials of HACCP in order to keep fixed costs to a minimum. Second, FDA is developing considerable guidance in the form of a hazard guide and model HACCP plans to enable small processors to implement an effective HACCP system at the lowest possible cost. Third, FDA is also aware that academia and trade associations are available to assist processors to implement HACCP. Finally, for those small processors that have very simple operations requiring few critical control points, an inherent feature of HACCP is that it adjusts to the complexity and risks of an operation. While any closure is regrettable, the agency strongly believes that firms that are unable to identify the likely hazards associated with their products and take reasonable preventive controls to prevent those hazards from occurring should not be selling food in interstate commerce. As described in the preamble, FDA is keenly interested in keeping the costs of implementing HACCP to a minimum and is issuing guidance documents and model HACCP plans to facilitate such implementation. FDA is specifically requesting comment in areas where costs and benefit estimates are either very uncertain or potentially large. FDA will utilize answers received on these comments along with all other comments to help formulate the final rule. 1. Costs FDA specifically requests comments on: (1) The expected cost to retrofit plants as necessary for the proper operation of HACCP controls (e.g., enhance refrigerator capacity, water supply changes, etc.). (2) The cost of taking corrective actions to respond to critical limit deviations on an annual basis. FDA has estimated an average of $1,000 per firm to take such actions as discarding product, buying new equipment, and changing the processing practice. (3) The cost of training employees. FDA has estimated that there will be a cost per plant of $900 to train an employee to manage HACCP. This will include the cost of training, travel expenses, and loss of several days of productivity for that employee. Not all of these costs may be borne by manufacturers, however, because some training may be sponsored by academia, trade associations, and others. (4) The cost of ensuring that cooking and pasteurizing equipment and processes are achieving the desired safety results (i.e., destroying microbiological pathogens). This ensurance may be obtained by having equipment and processes that are equivalent to those found effective by a processing authority. FDA estimated that this would cost $1,000 per plant in the first year and, on average, half that amount in the following years as processors change their processes and equipment. This cost may be offset, however, by reliance on literature that contains the necessary information from a processing authority. (5) The cost of temperature indicators and thermometers for plants who do not now have this equipment. FDA estimated that the cost would be $1,000 per plant, initially, with replacement as necessary. (6) The cost of creating a HACCP plan from the guidance provided by FDA. FDA estimated that it will take processors with simpler processes 24 hours of managerial time to adapt the guidance into a HACCP plan. FDA estimated that it will take processors with more complex processes 72 hours of managerial time to adapt the guidance into a HACCP plan. (7) FDA requests comment on the recordkeeping burden associated with the proposed sanitation requirements in Sec. 123.10 (b) and (c). If possible, such estimates should be provided in terms of hours spent and translated into dollars if staff compensation rates are known. In addition, FDA was unable to provide cost estimates of the following provisions and requests specific comments on these areas: (1) Section 123.10(a)(7), prevention of cross-contamination by the separation of food-contact surfaces; (2) Section 123.10(a)(14), storage at 40 deg.F or below; (3) Appendix A.6., cooling after cooking; (4) Appendix B., scombroid toxin forming species; (5) Appendix 1., specifically, the guidance on smoked and smoke- flavored fishery products; (6) Increased short-term recall potential, if any, due to heightened industry awareness; (7) Increasing time spent escorting Federal inspectors, particularly in the initial phases; (8) The cost of restricting catch in certain areas and seasons if processors find it necessary. 2. Benefits (1) FDA is reprinting two tables from the PRIA and requests comments on both the baseline number of illnesses due to seafood and the likelihood that HACCP for processors will reduce those illnesses. The baseline number of illnesses reflects an estimate of all cases (from any source, including recreational harvest, retail, and consumer mishandling). FDA considers the estimates in both tables as preliminary estimates. Table 1.--Significant Hazards Associated With Seafood [All Seafood Sources Combined--Recreational and Commercial] ------------------------------------------------------------------------ Reported Upper-bound Estimated Hazards cases cases cases (annual) (annual) (annual) ------------------------------------------------------------------------ Anasakis......................... 1 100 100 Campylobacter jejuni............. 2 200 200 Ciguatera........................ 800 8,000 800 Clostridium botulinum............ 4 4 4 Clostridium perfringens.......... 7 70 70 Diphyllobothrium latum........... (\1\) 1,000 1,000 Giardia.......................... 3 50 30 Hepatitis A virus................ 9.2 6,700 92 Neurotoxic shellfish poisoning... 48 48 48 Norwalk virus.................... 12.4 30,000 12,400 Other Vibrios.................... 43 10,000 10,000 Paralytic shellfish poisoning.... 13.4 13.4 13.4 Salmonella nontyphi.............. 2 2,750 200 Scombrotoxin..................... 796 21,500 7,960 Shigella......................... 7 100 70 Vibrio vulnificus................ 24 48 48 -------------------------------------- Total........................ 1,772 80,389 33,035 ------------------------------------------------------------------------ \1\Unknown. Table 2.--Projected Number of Cases Averted Using HACCP Approach ------------------------------------------------------------------------ FDA best estimate Number of Number of Hazards of the cases cases number of averted averted cases (lower)* (upper)** ------------------------------------------------------------------------ Anasakis............................ 100 10 75 Campylobacter jejuni................ 200 100 150 Ciguatera........................... 800 50 100 Clostridium botulinum............... 4 0 1 Clostridium perfringens............. 70 53 70 Diphyllobothrum latum............... 1,000 250 750 Giardia............................. 30 0 7.5 Hepatitis A virus................... 92 15 46 Neurotoxic shellfish poisoning...... 48 0 0 Norwalk virus....................... 12,400 1,000 6,200 Other Vibrios....................... 10,000 1,000 5,000 Paralytic shellfish poisoning....... 13 0 0 Salmonella nontyphi................. 200 100 150 Scombrotoxin........................ 7,960 3,980 5,970 Shigella............................ 70 18 35 Vibrio vulnificus................... 48 0 24 ----------------------------------- Total........................... 33,035 6,575 18,679 ------------------------------------------------------------------------ *Estimates by Klontz and Altekruse. **Estimates by Archer. \1\Memorandum to Richard A. Williams, Jr., November 16, 1993. (2) FDA also specifically requests comments on the number of cases of illness included in the baseline estimate (33,035) that may be due to factors outside the processors' control, such as those due to recreational harvests (that are not eventually sent to processors), those due to restaurants and supermarkets, and those due to consumer mishandling. (3) As mentioned above, FDA has also estimated potential benefits associated with increased seafood consumption. These benefits will only be realized if the price increase resulting from this rule does not offset the effect of increased demand for seafood which will result from reduced consumer anxiety. FDA requests specific comment on the likelihood that seafood consumption will be increased as a result of this rule. (4) FDA has identified but not quantified benefits to seafood exporters as well as reduced public anxiety associated with the safety of seafood. FDA requests comments on these benefits (including how to quantify them) as well as other potential benefits such as how HACCP will help firms gain better control over their operations, better sanitation and greater efficiencies such as reduced product waste. E. Tribal Governments FDA is aware that some tribal governments are involved in the processing of seafood for interstate commerce. The agency expects that the proposed regulations will apply to them in such cases. Executive Order 12875 of October 26, 1993, requires, among other things, consultation with tribal governments before the formal promulgation of regulations containing unfunded Federal mandates. While FDA does not believe that the proposed regulations would impose an unfunded Federal mandate, the agency wishes to foster consultation on matters that might significantly affect tribal communities. Consequently, FDA specifically requests comment on the economic effect of the proposed regulations on tribal governments. F. Availability of PRIA/RFA FDA acknowledges considerable uncertainty in both cost and benefit estimates of the proposed regulations and requests comment on all aspects of the PRIA and the RFA. The full PRIA/RIA is available at the Dockets Management Branch (address above). XI. Environmental Impact The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. XII. Request for Comments Interested persons may, on or before April 28, 1994, submit to the Dockets Management Branch (address above) written comments regarding this proposal. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. XIII. References The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Committee on Diet and Health, Food and Nutrition Board, Commission on Life Sciences, National Research Council, ``Diet and Health: Implications for Reducing Chronic Disease Risk,'' National Academy Press, Washington, DC, 1989. 2. 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Graikoski, J.T., ``Effect of Heat and Environmental Conditions on the Survival and Outgrowth of Clostridium Botulinum Type E in Smoked Fish,'' unpublished, May 12, 1967. 155. Bott, T.L. et al., ``Clostridium Botulinum Type E in Fish From the Great Lakes,'' Journal of Bacteriology, 91(3):919, 1966. 156. Bott, T.L. et al., ``Possible Origin of the High Incidence of Clostridium Botulinum Type E in an Inland Bay (Green Bay of Lake Michigan),'' Journal of Bacteriology, 95(5):1542, 1968. 157. Craig, J.M., and K.S. Pilcher, ``The Natural Distribution of Cl. Botulinum Type E in the Pacific Coast Areas of the United States'' In M. Ingram, and T.A. Roberts, (eds.), ``Botulism 1966, Proceedings of the Fifth International Symposium on Food Microbiology: Moscow, July 1966,'' Chapman and Hall Ltd., London, 1967. 158. Craig, J.M., S. Hayes, and K.S. Pilcher, ``Incidence of Clostridium Botulinum Type E in Salmon and Other Marine Fish in the Pacific Northwest,'' Applied Microbiology, 16(4):553, 1968. 159. Eklund, M.W., and F. Poysky, ``Incidence of Cl. Botulinum Type E From the Pacific Coast of the United States,'' In M. Ingram, and T.A. Roberts, (eds.), ``Botulism 1966, Proceedings of the Fifth International Symposium on Food Microbiology: Moscow, July 1966,'' Chapman and Hall Ltd., London, 1967. 160. Hayes, S., J.M. Craig, and K.S. Pilcher, ``The Detection of Clostridium Botulinum Type E in Smoked Fish Products in the Pacific Northwest,'' Canadian Journal of Microbiology, 16(3):207, 1970. 161. U.S. Department of the Interior and U.S. Department of Health, Education, and Welfare, ``Sanitation Standards for Smoked- Fish Processing; 1967 Recommendations,'' Public Health Service Publication No. 1587, 1967. 162. Guthrie, R.K., ``Sanitation in Food Production and Processing,'' In R.K. Guthrie, ``Food Sanitation,'' p. 131, AVI Publishing Co., Inc., Westport, CT, 1980. 163. Christiansen, L.N. et al., ``Survival and Outgrowth of Clostridium Botulinum Type E Spores in Smoked Fish,'' Applied Microbiology, 16(1):133, 1968. 164. United States v. Nova Scotia Food Products Corp., U.S. Court of Appeals, Second Circuit, 1977, 568 F.2d 240. 165. Anonymous, Monthly Epidemiological Bulletin, State of Israel Ministry of Health, December 1987. 166. Centers for Disease Control, ``International Outbreak of Type E Botulism Associated With Ungutted, Salted Whitefish,'' Morbidity and Mortality Weekly Report, 36(49):812, 1987. 167. Centers for Disease Control, ``Botulism Associated With Commercially Distributed Kapchunka--New York City,'' Morbidity and Mortality Weekly Report, 34(35):546, 1985. 168. Badhey, H. et al., ``Two Fatal Cases of Type E Adult Food- borne Botulism With Early Symptoms and Terminal Neurologic Signs,'' Journal of Clinical Microbiology, 23(3):616, 1986. 169. EIR's conducted by FDA. 170. Letter to D.A. Kautter from Alan L. Hoeting, July 31, 1987. 171. Codex Alimentarius Commission, ``Thirteenth Session of the Codex Committee on Fish and Fishery Products, RCP-25, Recommended International Code of Practice for Smoked Fish,'' 1979. 172. Codex Alimentarius Commission, ``Thirteenth Session of the Codex Committee on Fish and Fishery Products, RCP-26, Recommended International Code of Practice for Salted Fish,'' 1979. 173. Eklund, M.W., ``Significance of Clostridium Botulinum in Fishery Products Preserved Short of Sterilization,'' Food Technology, 35(12):107, 1982. 174. Schmidt, C.F., R.V. Lechowich, and J.F. Folinazzo, ``Growth and Toxin Production by Type E Clostridium Botulinum Below 40 deg.F,'' Journal of Food Science, 26:626, 1961. 175. CPG No. 7108.17; Salt-cured, Air-Dried, Uneviscerated Fish (53 FR 44949, November 7, 1988), Docket No. 88D-0306. 176. Graham, P.P., R.S. Hamilton, and M. D. Pierson, ``Influence of Bringing Procedures on Salt Content and Distribution in Smoked Whitefish Chubs,'' Journal of Food Processing and Preserving, 10:295, 1986. 177. Deng, J., R.T. Toledo, and D.A. Lillard, ``Effect of Smoking Temperatures on Acceptability and Storage Stability of Smoked Spanish Mackerel,'' Journal of Food Science, 39:596, 1974. 178. Chan, W.S., R.T. Toledo, and J. Deng, ``Effect of Smokehouse Temperature, Humidity, and Air Flow on Smoke Penetration into Fish Muscle,'' Journal of Food Science, 40:240, 1975. 179. Pelroy, G.A. et al., ``Inhibition of Clostridium Botulinum Types A and E Toxin Formation by Sodium Nitrite and Sodium Chloride in Hot-process (Smoked) Salmon,'' Journal of Food Protection, 45(9):833, 1982. 180. Eklund, M.W., testimony presented at New York State Department of Agriculture and Markets' hearing, May 13, 1989. 181. Newberry, R.E., Letter to City Smoked Fish Co., Use of Colors in Smoked Salmon, March 11, 1985. 182. National Fisheries Institute, Inc., ``Techniques For Smoking Fish,'' Washington, DC. 183. Borgstrom, G., ``Smoking,'' in ``Fish as Food, Processing: Part I, Vol. 3,'' p. 88, Academic Press, New York, 1965. 184. Kautter, D.A., memorandum, ``Aqueous Phase Salt Concentration for Vacuum Packaged Cold-smoked Fish,'' April 6, 1990. 185. Eklund, M.W. et al., ``Feasibility of a Heat-pasteurization Process for the Inactivation of Nonproteolytic Clostridium Botulinum Types B and E in Vacuum-packaged, Hot-process Smoked Fish,'' Journal of Food Protection, 51(9):720, 1988. 186. Eklund, M.W., D.I. Wieler, and F.T. Poysky, ``Outgrowth and Toxin Production of Nonproteolytic Type B Clostridium Botulinum at 3.3 to 5.6 deg.C,'' Journal of Bacteriology, 93(4):1461, 1967. 187. Solomon, H.M. et al., ``Effect of Low Temperatures on Growth of Clostridium Botulinum Spores in Meat of the Blue Crab,'' Journal of Food Protection, 40(1):5, 1977. 188. Ohye, D.F., and W.J. Scott, ``Studies in the Physiology of Clostridium Botulinum Type E,'' Australian Journal of Biological Science, 10:85, 1956. 189. National Research Council, ``An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients,'' p. 249, National Academy Press, Washington, DC. 190. Federal Standard, ``Sanitation Standards For Fish Plants,'' FED-STD-369, Academy of Health Sciences, U.S. Army, Fort Sam Houston, Houston, TX, August 2, 1977. 191. Masso T.W., letters to T. Schwarz With AFDO Resolution No. 8, June 8, 1990. 192. Bryan, F.L., ``Application of HACCP to Ready-to-eat Chilled Foods,'' Food Technology, 44(7):70, 1990. 193. Tartakow, I.J., and J.H. Vorperian, (eds.), ``Foodborne and Waterborne Diseases: Their Epidemiologic Characteristics,'' p. 50- 52, AVI Publishing Co., Westport, CN, 1981. 194. Rhodehamel, J.E., N.R. Reddy, and M.D. Pierson, ``Botulism: The Causative Agent and its Control in Foods: A Review,'' Food Control, 3(3):125-143, 1992. 195. FDA, ``Human Foods; Current Good Manufacturing Practice (Sanitation) in Manufacturing, Processing, Packing, or Holding Smoked Fish,'' 34 FR 17176, October 23, 1969. 196. FDA, Part 110--Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR part 110). 197. FDA, FDA Inspections Manual, Chapter 5, Establishment Inspection, Subchapter 530, Food. 198. Center for Disease Control, ``Fish Botulism--Hawaii, 1990,'' Morbidity and Mortality Weekly, 40(24):412-414, June 21, 1991. 199. FDA, ``Studies in Food Sanitation Control--Year Five, Contract No. 223-80-2295, Task XVI, Effect of Controlled Humidity of Processing Ovens at High Operating Temperatures on Production of Smoked Fish,'' June 14, 1984. 200. Printout of FDA FY 90/91 Domestic Fish and Fishery Products Assignment Inspection Data as of August 6, 1991. 201. Daniels, Richard W., ``Applying HACCP to New Generation Refrigerated Foods at Retail and Beyond,'' Food Technology, June 1991. List of Subjects 21 CFR Part 123 Fish, Fishery products, Imports, Reporting and recordkeeping requirements, Seafood. 21 CFR Part 1240 Communicable diseases, Public health, Travel restrictions, Water supply. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be amended as follows: 1. Part 123 is added to read as follows: PART 123--FISH AND FISHERY PRODUCTS Subpart A--General Provisions Sec. 123.3 Definitions. 123.5 Current good manufacturing practice (sanitation). 123.6 Hazard Analysis Critical Control Point (HACCP) plan. 123.7 Corrective actions. 123.8 Records. 123.9 Training. 123.10 Sanitation control procedures. 123.11 Obligations of importers. 123.12 Imports--determination of compliance. Subpart B--[Reserved] Subpart C--Raw Molluscan Shellfish 123.20 General. 123.28 Source controls and records. Appendix A to Part 123--Cooked, Ready-to-eat Fishery Products Appendix B to Part 123--Scombroid Toxin Forming Species Appendix C to Part 123--[Reserved] Appendix D to Part 123--Product Integrity Authority: Secs. 201, 402, 403, 406, 409, 701, 704, 721, 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381); secs. 301, 307, 361, 1702 of the Public Health Service Act (42 U.S.C. 241, 242l, 264, 300u-1). Subpart A--General Provisions Sec. 123.3 Definitions. The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act and in part 110 of this chapter are applicable to such terms when used in this part. The following definitions shall also apply: (a) Certification number means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish processor. (b) Cooked, ready-to-eat fishery product means a fishery product that is subjected by a commercial processor to either a cooking process before being placed in a final container, or to pasteurization in the final container, or to both. (c) Critical control point means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard in the final food. (d) Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk of occurrence of the identified hazard. (e) Fish means fresh or saltwater finfish, molluscan shellfish, crustaceans, and other forms of aquatic animal life other than birds or mammals. (f) Fishery product means any edible human food product derived in whole or in part from fish, including fish that has been processed in any manner. (g) Harvester means a person who has an identification number issued by a shellfish control authority for commercially taking molluscan shellfish by any means from a growing area. (h) Importer means a person, or his representative in the United States, who is responsible for ensuring that goods being offered for entry into the United States are in compliance with all laws affecting the importation. (i) Lot of molluscan shellfish means a collection of shellstock or containers of shellstock of no more than 1 day's harvest from a single, defined growing area harvested by one or more harvesters. (j) Molluscan shellfish means any edible species of fresh or frozen oysters, clams, mussels and scallops or edible portions thereof, except when the scallop product consists entirely of the shucked adductor muscle. (k) Potable water means water which meets the U.S. Environmental Protection Agency's Primary Drinking Water Regulations as set forth in 40 CFR part 141. (l) Process control instrument means an instrument or device used to monitor conditions during processing at a critical control point. (m) Processing means, with respect to fish or fishery products, handling, storing, preparing, heading, gutting, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, or holding. Practices such as heading or gutting intended solely to prepare a fish for holding on board a harvest vessel are excluded. This regulation does not cover the operation of a retail establishment. (n) Processor means any person engaged in commercial, custom, or institutional processing of fish or fishery products, either in the United States or in a foreign country. Persons engaged in the production of foods that are to be used in market or consumer tests are also included. Persons who only harvest or transport seafood, without otherwise engaging in processing, are not covered by these regulations. (o) Shall is used to state mandatory requirements. (p) Shellfish control authority means a Federal or State health authority, or foreign government health authority, legally responsible for the administration of a program that includes classification of molluscan shellfish growing areas, enforcement of harvesting controls, and certification of molluscan shellfish processors. (q) Shellstock means raw, in-shell molluscan shellfish. (r) Should is used to state recommended or advisory procedures or to identify recommended equipment. (s) Shucked shellfish means molluscan shellfish that have one or both shells removed. (t) Tag means a record of harvesting information attached to a container of shellstock by the harvester or processor. Sec. 123.5 Current good manufacturing practice (sanitation). (a) The criteria in part 110 of this chapter apply in determining whether the facilities, methods, practices, and controls used to process fish and fishery products are safe, and whether these products have been processed under sanitary conditions. (b) The purpose of subpart A of this part is to set forth requirements specific to the processing of fish and fishery products. Sec. 123.6 Hazard Analysis Critical Control Point (HACCP) plan. (a) Every processor and importer shall have and implement a written HACCP plan that is specific to: (1) Each location where fish and fishery products are processed by that processor; and (2) Each kind of fish and fishery product processed by the processor. The plan may group kinds of fish and fishery products together if the hazards, critical control points, critical limits, and procedures required to be identified in paragraph (b) of this section are identical for all fish and fishery products so grouped. (b) The HACCP plan shall: (1) Identify the safety hazards that are reasonably likely to occur and that thus must be controlled for each fish and fishery product, including, as appropriate: (i) Natural toxins; (ii) Microbiological contamination; (iii) Chemical contamination; (iv) Pesticides; (v) Drug residues; (vi) Decomposition; (vii) Parasites; (viii) Unapproved direct and indirect food and color additives; and (ix) Physical hazards; (2) Identify the critical control points for each of the identified hazards; (3) Identify the critical limits that must be met at each of the critical control points; (4) Identify the procedures, and frequency thereof, including the use of consumer complaints received by the processor or importer, that will be used to control and monitor each of the critical control points to ensure compliance with the critical limits. Such procedures shall include the calibration of process control instruments and validation of software for computer control systems as appropriate; (5) Provide for a recordkeeping system that will document the monitoring of the critical control points. The records shall contain the actual values obtained during monitoring. The records shall also include consumer complaints that relate to the operation of critical control points or possible critical limit deviations. (c) In addition, the HACCP plan should: (1) Identify other consumer hazards not related to the safety of the product, including, but not necessarily limited to: (i) Decomposition not associated with human illness; and (ii) Economic adulteration. (2) Provide for control of these hazards in the manner described by paragraphs (b)(2) through (b)(5) of this section. (d) Failure of a processor or importer to have and implement an HACCP plan that complies with this section or to operate in accordance with the requirements of this part, shall render the products of that processor or importer adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Sec. 123.7 Corrective actions. (a) Any critical limit deviation shall require: (1) Segregation and holding of the affected product, at least until the requirements of paragraphs (a)(2) and (a)(3) of this section are met; (2) Immediate review by an individual or individuals who have been trained in accordance with Sec. 123.9, to determine the acceptability of the lot in question for distribution, based on a judgment as to whether the deviation may have rendered the product in that lot injurious to health or otherwise adulterated; (3) Corrective action, when necessary, with respect to the affected product and the critical control point at which the deviation occurred; (4) Timely assessment by an individual or individuals who have been trained in accordance with Sec. 123.9, to determine whether the process or Hazard Analysis Critical Control Point (HACCP) plan needs to be modified to reduce the risk of recurrence of the deviation; and (5) Modification when necessary as it applies to the process or HACCP plan. (b) When a processor or importer receives a consumer complaint that may be related to the performance of a critical control point or that may reflect a critical limit deviation, it shall determine whether corrective action as described by paragraph (a) of this section is appropriate and, if so, it shall take such action. (c) All actions required by paragraphs (a) and (b) of this section shall be documented in records that are subject to the requirements of Sec. 123.8. Sec. 123.8 Records. (a) Records required by this part that involve observations or measurements during processing or related activities, including corrective actions taken in accordance with Sec. 123.7, shall include the identity of the product, product code, and date of activity that the record reflects. Processing and other information shall be entered at the time that it is observed. Each record shall be signed by the operator or observer, except that corrective action records need only be signed in accordance with paragraph (b) of this section. (b) Records required by this part shall be reviewed, signed, and dated by an individual who has been trained in accordance with Sec. 123.9, before distribution of the product for completeness and compliance with the established critical limits. (c) The records required by this part shall be retained at the processing facility or the importer's place of business in the United States for at least 1 year after the date they were prepared in the case of refrigerated products and for at least 2 years after the date they were prepared in the case of frozen or preserved products. Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least 2 years after their applicability to the product being produced at the facility. If the processing facility is closed between seasonal packs, the records may be transferred to some other reasonably accessible location during the period of closure. (d) All records required by this part, including HACCP plans required in Sec. 123.6 and consumer complaints that may be related to a critical limit deviation, shall be available for review and copying at reasonable times by duly authorized officers and employees. (e) Tags as defined in Sec. 123.3(t) are not subject to the requirements of this section. Sec. 123.9 Training. Each processor and importer shall employ at least one individual who has successfully completed a prescribed course of instruction in the application of Hazard Analysis Critical Control Point (HACCP) principles to fish and fishery product processing at a program of instruction approved by the Food and Drug Administration. At a minimum, this individual shall be responsible for developing and modifying the plan as required by Sec. 123.6, evaluating critical limit deviations and corrective actions as required by Sec. 123.7, and performing record review as required by Sec. 123.8(b). Sec. 123.10 Sanitation control procedures. (a) Every processor and importer who takes physical possession of fish or fishery products and engages in the processing of such fish or fishery products, including storing such products, shall perform sanitation inspections and ensure at a minimum that, to the extent applicable to the operations conducted by the processor or importer, the following conditions apply: (1) Water that directly comes into contact with a product or with food contact surfaces, or is used in the manufacture of ice, is derived from a safe and sanitary source or is being treated to render it of safe and sanitary quality. (2) There are no cross connections between the potable water system and any nonpotable system. (3) All food contact surfaces of plant equipment and utensils, including equipment used for ice production and storage, are so designed and of such material and workmanship as to be easily cleanable, and are maintained in a sanitary condition. Such surfaces shall be constructed of nontoxic materials and designed to withstand the environment of its intended use and the action of the food, cleaning compounds, and sanitizing agents. (4) All utensils and surfaces of equipment that contact food during processing are cleaned and sanitized with effective cleaning and sanitizing preparations with the following frequency: (i) Cleaned at the end of the day's operations; (ii) Cleaned and sanitized at least every 4 hours during the processing of cooked, ready-to-eat fishery products; and (iii) Sanitized before the beginning of the day's operations. (5) Gloves and outer garments that contact food or food contact surfaces are made of an impermeable material and are maintained in a clean and sanitary condition. (6) Employees' hands, gloves, outer garments, utensils and food contact surfaces of equipment that come into contact with waste, the floor, or other insanitary objects, do not contact fish or fishery products without first being adequately cleaned and sanitized. (7) Where applicable, employee's hands, gloves, outer garments, utensils and food contact surfaces of equipment that come into contact with raw product shall not contact cooked product or ice used on cooked product, without first being adequately cleaned and sanitized. (8) Hand washing and hand sanitizing facilities are: (i) Located in all processing areas in which good sanitary practice requires employees to wash and sanitize their hands; and (ii) Equipped with hand-cleaning and effective sanitizing preparations and single service towels or suitable hand drying devices. (9) Food, food contact surfaces, and food-packaging materials shall be protected from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, metal fragments, or other chemical or physical contaminants. (10) Toxic compounds shall be identified, held, used, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. (11) Food, food-contact surfaces, and food-packaging materials shall be protected from contaminants that may drip, drain, or be drawn into the food. (12) Compressed gases that contact food or food contact surfaces of equipment shall be filtered or treated in a way that ensures that they will not contaminate the food with unapproved indirect food additives or other chemical, physical, or microbiological contaminants. (13) Unprotected cooked, ready-to-eat fishery products, smoked fishery products, raw molluscan shellfish, and raw fish and fishery products shall be physically separated from each other during refrigerated storage. (14) Refrigeration units that store raw materials, in-process, or finished fish or fishery products that are cooked, ready-to-eat, smoked, or made in whole or in part from scombroid toxin forming species shall be operated at a temperature of 40 deg.F (4.4 deg.C) or below. (15) Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other source of microbial contamination by which there is a reasonable possibility that food, food-contact surfaces, or food-packaging materials will become contaminated, shall be excluded from any operations that may be expected to result in such contamination until the condition is corrected. (16) Adequate, readily accessible toilet facilities that provide for proper sewage disposal shall be available and maintained in a sanitary condition and in good repair. (17) No pests are in any area of a food plant. (18) The plant is designed to minimize the risk of contamination of the food, food-contact surfaces, and food-packaging material. (b) Each processor shall maintain sanitation control records that document that the steps required under paragraph (a) of this section are performed with requisite frequency. (c) Sanitation control measures shall be taken on a daily basis, and the sanitation control records shall be prepared according to the requirements of paragraph (a) of this section, except that: (1) The hand sanitizer strength and sanitary practices of the processing employees, especially as these relate to hand washing and sanitizing practices and the potential for cross contamination, shall be checked and recorded at least every 4 hours during processing. (2) All utensils and food-contact surfaces of equipment shall be inspected immediately after each cleaning and sanitizing operation under paragraph (a)(4)(ii) of this section. Each such cleaning and sanitizing shall be documented, and such documentation shall at a minimum record the time of each cleaning, the concentration of the sanitizer, and the condition of the equipment. (3) The requirements of paragraphs (a)(1), (a)(2), (a)(3), (a)(8)(i), (a)(12), and (a)(18) of this section shall be performed and documented with such frequency as is necessary to ensure control. (4) The requirement of paragraph (a)(14) of this section shall be ensured by the continuous monitoring of the refrigeration unit with an accurate process control instrument. The instrument shall be checked and the measurements documented with such frequency as is necessary to ensure control. (d) Where deviations from the requirements of paragraph (a) of this section are noted during these inspections, appropriate corrective actions shall be taken and documented on the sanitation control record. (e) Every plant should have a written standard operating procedure (SOP) for assuring the maintenance of proper sanitary conditions and practices during processing that is specific to each fish and fishery product produced at that location. The SOP should include, at a minimum, requirements as described in paragraph (a) of this section. (f)(1) All fish to be smoked or salted shall be eviscerated and free of residual viscera, except for: (i) Small species of fish, such as anchovies and herring sprats, provided that they are processed in a fashion so that they contain a water-phase salt level of at least 10 percent, a water activity below 0.85, or a pH of 4.6 or less; and (ii) Fish that are fully cooked before further processing. (2) Evisceration shall be conducted in an area that is segregated and separate from other processing operations. Evisceration shall be performed with minimal disturbance of the intestinal tract contents. The fish, including the body cavity, shall be washed thoroughly with a vigorous water spray or a continuous water flow system. Sec. 123.11 Obligations of importers. This section sets forth the specific obligations of importers of fish and fishery products into the United States. (a) An importer of fish or fishery products shall have and implement a Hazard Analysis Critical Control Point (HACCP) plan in accordance with Sec. 123.6 that describes how the fish will be prepared, packed, or held while it is in the control of the importer. (b) The importer of fish or fishery products shall have on file the HACCP plans of each of its foreign processors. (c) The importer shall take affirmative steps to ensure that the fish and fishery products that it offers for import were produced under the HACCP plan that it has in its possession and subject to the sanitation controls listed in Sec. 123.10. Such steps may include, but would not be limited to: (1) Obtaining from the foreign processor the HACCP monitoring records that relate to the specific fish or fishery products being offered for import. (2) Obtaining a certificate from a foreign government inspection authority certifying that the firm is operating under a valid HACCP plan or certification on a lot-by-lot basis. (3) Regularly inspecting its suppliers' facilities to ensure that they are being operated in compliance with the applicable HACCP plan and Sec. 123.10. (4) Periodic end-product testing by the importer or a private laboratory hired by the importer; or (5) Other such verification measures as appropriate. (d) An importer's obligation under paragraph (c) of this section will be satisfied if the importer imports product from a country that has an active memorandum of understanding (MOU), or similar agreement, with FDA that documents the equivalency of the inspection system of the foreign country with the U.S. system. The active MOU will be expected to accurately reflect the current situation between the signing parties and be functioning and enforceable in its entirety. (e) Importers should encourage foreign processors to obtain HACCP training similar to that required by Sec. 123.9. Sec. 123.12 Imports--determination of compliance. (a) There must be evidence that seafood that is offered for import has been produced under conditions that comply with subpart A of this part. Such evidence can be provided by: (1) Examination, at the U.S. importer's place of business, of the importer's Hazard Analysis Critical Control Point (HACCP) plan, the foreign processor's HACCP plan and sanitation procedures and records associated with the importer's plan that demonstrate that the plan and procedures were followed. (2) An active memorandum of understanding (as defined in Sec. 123.11(d)) with an exporting country that provides that the country will impose regulatory controls equivalent to those established in this part for domestic processors. (3) Evidence that an exporting country has in place and is enforcing an HACCP-based regulatory system. (4) Inspection of foreign processors by FDA or some other organization designated by FDA. (5) Any other measures that FDA deems appropriate, including, but not limited to, end-product testing. (b) If assurances do not exist that the product has been produced under an HACCP plan and sanitation controls that are equivalent to those required of domestic processors, the product will appear to be adulterated and will be denied entry. Subpart B--[Reserved] Subpart C--Raw Molluscan Shellfish Sec. 123.20 General. This subpart augments subpart A of this part by setting forth specific requirements for processing fresh or frozen molluscan shellfish. Sec. 123.28 Source controls and records. (a) In order to meet requirements of subpart A of this part as they apply to microbiological contamination, natural toxins, and related hazards, processors shall include in their Hazard Analysis Critical Control Point (HACCP) plans how they are controlling the origin of the molluscan shellfish they process. (b) Processors shall only process molluscan shellfish that originate from growing waters approved for harvesting by a shellfish control authority. To meet this requirement, processors shall only receive shellstock: (1) From a harvester that is licensed or a processor that is certified by a shellfish control authority; and (2) That has affixed a tag on each container of shellstock received by the processor that bears, at a minimum, the information required in Sec. 1240.60(b) of this chapter. (3) Bulk shellstock shipments may be identified by a bill of lading or similar document that contains the same information. (c) The same requirements that apply to shellstock shall apply to shucked molluscan shellfish received by a processor except that, in lieu of a tag, the body of the container of shucked molluscan shellfish shall bear a label that complies with Sec. 1240.60(c) of this chapter. (d) Processors shall maintain records that document that each lot of molluscan shellfish meet the requirements of paragraphs (b) and (c) of this section. (1) For shellstock these records shall document: (i) The date of harvest; (ii) The location of harvest by State and site; (iii) The quantity and type of shellfish; (iv) The date of receipt by the processor; and (v) The name of the harvester and identification number. (2) For shucked shellfish these records shall document: (i) The date of receipt; (ii) The quantity and type of shellfish; and (iii) The name and certification number of the shipper. Appendix A to Part 123--Cooked, Ready-to-Eat Fishery Products 1. General guidelines for cooked, ready-to- eat fishery products. 2. Definitions in Appendix A. 3. Critical control points. 4. Thermal processing critical control points. 5. Container integrity critical control points. 6. Time and temperature critical control points. 7. Temperature monitoring equipment. 8. Corrective actions. 9. Sanitary zones. 1. General Guidelines for Cooked, Ready-to-Eat Fishery Products This Appendix provides guidance on how to meet the requirements of 21 CFR part 123, subpart A for the processing of cooked, ready- to-eat fishery products. Cooked, ready-to-eat fishery products are those that are subjected by a commercial processor to either a cooking process before being placed in a final container, or to pasteurization in the final container, or to both. This guidance involves processing procedures that are common to most of these products for the control of the microbiological hazards to which they are particularly susceptible. The guidance does not apply to environmental or other hazards that might occur before the processor takes possession of the product or raw materials. (Guidance on these hazards may be found in a separate guidance document for all fish and fishery products to be issued by FDA.) This guidance also does not apply to cooked, ready-to-eat fishery products covered by 21 CFR part 123, subpart B. 2. Definitions in Appendix A a. Cooking process means the application of sufficient heat for a sufficient period of time to a fish or fishery product to coagulate the protein throughout the product. b. Hermetically sealed package means a container that is designed and intended to be secure against the entry of microorganisms. c. Microorganisms of public health significance means bacteria, fungi, and viruses capable of producing illness if they or their toxins are ingested by humans. d. Pasteurization means a process applied to a fish or fishery product after that fish or fishery product has been placed in a final, hermetically sealed package, which involves the application of sufficient heat or other processes for a sufficient period of time to result in the reduction of microorganisms of public health concern to levels that, under normal conditions of storage, are unlikely to cause disease. e. Process authority means a person having expert knowledge of commercial processing of fish and fishery products based on a combination of education, training and experience. f. Raw materials means fish and fishery products that are received for processing and include fishery products that have been processed elsewhere and that are received for further processing. g. Temperature-indicating device means a mercury-in-glass thermometer or equivalent device, such as a resistance temperature device or thermocouple. h. Temperature-recording device means a device that is capable of providing a continuous record of the temperature conditions being monitored. 3. Critical Control Points Hazard Analysis Critical Control Point (HACCP) plans prepared in accordance with 21 CFR part 123, subpart A will typically identify and address the following critical control points: a. Cooking; b. Pasteurization; c. Finished product container sealing for pasteurized products; d. Post-pasteurization cooling; e. Cooling after cooking; f. Processing after cooking; g. Final product cooling; h. Refrigerated storage; and i. Distribution. In accordance with 21 CFR part 123, subpart A, processors shall identify in their HACCP plans how they will control hazards at critical control points. The measures in sections 4. through 6. of this Appendix are suitable for HACCP plans. 4. Thermal Processing Critical Control Points a. Cooking 1. The Cooking Process. The processor must be able to demonstrate to itself and to FDA that its cooking process ensures the destruction of vegetative cells of microorganisms of public health concern. This may be accomplished by having a cooking process that is at least equivalent to a process established by a process authority. To demonstrate equivalence, a processor should have on file in its Hazard Analysis Critical Control Point (HACCP) records a document that: i. Describes the results of a scientific evaluation, conducted by a process authority, of the adequacy of the cooking process; and ii. Identifies and establishes values for key aspects of the process or of the product that may affect the adequate destruction of microorganisms of public health concern. At a minimum, these values should include cooking times and temperatures. Such a document may consist of, but should not be limited to, a letter from a process authority, articles in scientific journals, or Federal, State, or local government regulations or advisories. Failure to have documentation that the cooking process will achieve its goal will violate 21 CFR 123.8 and will mean that the product produced by the processor will be produced under insanitary conditions whereby it may be rendered injurious to health. 2. Cooking Equipment Design. i. The processor must be able to demonstrate to itself and to FDA that its cooking equipment can deliver the cooking process that ensures the destruction of vegetative cells of microorganisms of public health concern. One way to accomplish this is for the processor to have on file in its HACCP records a document that describes the results of a scientific evaluation, conducted by a process authority, of the design and operation of the type of equipment and the operational procedures used by the processor. The engineering specifications for the equipment used by the processor (e.g., pipe sizes, flow rates, loading configuration, and, whenever a steam process is used, venting parameters) should meet or exceed those for the equipment evaluated by the process authority. Failure to have documentation that the cooking equipment will achieve its goal will violate 21 CFR 123.8 and will mean that the product produced by the processor will be produced under insanitary conditions whereby it may be rendered injurious to health. ii. Cooking equipment should be equipped with both a temperature-indicating device and temperature-recording device. The temperature-indicating device should be the reference instrument for determining conformance to the established process temperatures. 3. Records. Monitoring records made by the processor should record both the actual values that are occurring for those key aspects of the process identified by the process authority in section 4.a.1. of this Appendix and the actual values that are occurring for operational procedures identified by the process authority in section 4.a.2.i. of this Appendix. 4. Special Considerations. For the cooking of blue crab (Callinectes sapidus), dungeness crab (Cancer magister), or king crab (Paralithodes camtschatica), the known lethality of the cooking process necessary to make the product generally acceptable for human consumption, or to enable further processing, is sufficient so that the adequacy of the process and the equipment can normally be assumed. b. Pasteurization 1. The Pasteurization Process. The processor must be able to demonstrate to itself and to FDA that its pasteurization process ensures the adequate reduction of numbers of viable spores of microorganisms of public health concern. One way to accomplish this is to have a pasteurization process that is equivalent to a process established by a process authority. To demonstrate equivalence, a processor should have on file in its HACCP records a document that: i. Describes the results of a scientific evaluation conducted by a process authority of the adequacy of the pasteurization process; and that ii. Identifies and establishes values for those key aspects of the process, or of the product, that may affect the adequate reduction in numbers of microorganisms of public health concern. At a minimum, these values should include pasteurization times and temperatures. Such document may consist of, but should not be limited to, a letter from a process authority, articles in scientific journals, or Federal, State or local government regulations or advisories. Failure to have documentation that the pasteurization process will achieve its goal will violate 21 CFR 123.8 and will mean that the product produced by the processor will be produced under insanitary conditions whereby it may be rendered injurious to health. 2. Pasteurization Equipment Design. i. The processor must be able to demonstrate to itself and to FDA that its pasteurization equipment can deliver the pasteurization process that ensures the adequate reduction of viable spores of microorganisms of public health concern. One way to accomplish this is to have on file a document that describes the results of a scientific evaluation conducted by a process authority, of the design and operation of the type of equipment used by the processor. The engineering specifications for the equipment used by the processor (e.g., pipe sizes, flow rates, loading configuration) should meet or exceed those for the equipment evaluated by the process authority. Failure to have documentation that the pasteurization equipment will achieve its goals will violate 21 CFR 123.8 and will mean that the product produced by the processor will be produced under insanitary conditions whereby it may be rendered injurious to health. ii. Pasteurization equipment should be equipped with both a temperature-indicating device and temperature-recording device. The temperature-indicating device should be the reference instrument for determining conformance to the established process temperatures. 3. Records. Monitoring records made by the processor should record the actual values that are occurring for those key aspect of the process identified by the process authority in section 4.b.1.ii of this Appendix. 5. Container Integrity Critical Controls Points a. Finished Product Container Sealing Finished product containers must be inspected, and the results recorded, for container integrity to assure a consistently reliable hermetic seal. FDA recommends that: 1. Visual seam inspection of one container from each seaming head occur every 30 minutes; and 2. Testing by qualified personnel of one container from each seaming head occur at least every 4 hours. As applicable, these tests should be performed in accordance with 21 CFR 113.60(a)(1) and (a)(2). b. Post-pasteurization Cooling Container cooling water must contain a measurable residual of chlorine or other sanitizer. Tests to determine the presence of a measurable residual of chlorine or other sanitizer in the container cooling water should be made, and the results recorded, at sufficient frequency to ensure control. 6. Time and Temperature Critical Control Points a. Cooling After Cooking After cooking, the product must be rapidly cooled to minimize recontamination. Continuous cooling from 140 deg.F (60 deg.C) to achieve an internal temperature of 70 deg.F (21.1 deg.C) or below within 2 hours and an internal temperature of 40 deg.F (4.4 deg.C) or below within an additional 4 hours, unless processing after cooking, as described in section 6.b. of this Appendix, occurs during either of these time periods, will effectively minimize recontamination. Other time/temperature parameters may also be effective. Processors should ensure that the cooling parameters are met by either: 1. Monitoring. Monitoring and recording internal product temperatures at least every 2 hours; or 2. Studies. i. Conducting or obtaining a study that establishes that appropriate cooling temperatures are always met under prescribed processing conditions. The study should establish the limits of significant variables that could affect the rate of cooling. These variables may include product size, ambient air temperature, and amount of product in the cooler. An adequate study should consist of at least three processing runs under the prescribed processing conditions; and ii. Monitoring and recording the prescribed processing conditions as identified by the study in section 6.a.2.i. of this Appendix at least every 2 hours. b. Processing After Cooking Products that will receive processing after cooking should not be exposed to ambient temperatures of 40 deg.F (4.4 deg.C) or higher for longer than a cumulative total of 4 hours after cooking. If they are exposed to such temperatures for more than 4 hours, unacceptable recontamination is the likely result. Processors are required to regularly monitor and record the length of time that the product is exposed to temperatures above 40 deg.F (4.4 deg.C) under 21 CFR 123.8. FDA recommends that such monitoring and recording be done at least every 2 hours. c. Final Product Cooling To avoid microbiological hazards for perishable finished products, the internal temperature of the finished product should be 40 deg.F (4.4 deg.C) or below within 4 hours of either placement in a finished product container or the completion of pasteurization. Processors should either conduct: 1. Monitoring. Monitor and record internal product temperatures at least every 2 hours; or 2. Studies. i. Conduct or obtain a study that establishes that the internal temperature of the finished product will always be 40 deg.F (4.4 deg.C) or below within 4 hours of either placement in a finished product container or completion of pasteurization under prescribed processing conditions. The study should establish the limits of significant variables that could affect the rate of cooling. These variables may include product size, ambient air temperature, and amount of product in the cooler. An adequate study should consist of at least three processing runs under the prescribed processing conditions; and ii. Monitoring and recording the prescribed processing conditions as identified by the study in section 6.c.2.i. of this Appendix at least every 2 hours. d. Refrigerated Storage 1. In-process products. Refrigeration units that are being used to store in-process products or finished products shall operate at a temperature of 40 deg.F (4.4 deg.C) or below in accordance with 21 CFR 123.10(a)(14). 2. Temperature devices. Units should be equipped with both a temperature-indicating device and a temperature-recording device. In lieu of a temperature-recording device, a processor may equip a refrigeration unit with a high temperature alarm or a maximum- indicating thermometer and maintain a temperature log that notes temperature with such frequency as is necessary to achieve control. e. Distribution All perishable finished products should be distributed in a manner that ensures that the internal temperature is maintained at 40 deg.F (4.4 deg.C) or below. 7. Temperature Monitoring Equipment Where reference is made in this Appendix to temperature- indicating devices and temperature-recording devices, the following conditions should apply: a. Temperature-Indicating Devices Temperature-indicating devices should be installed where they can be easily read and located to ensure that they accurately measure the warmest temperature of the refrigeration equipment and the coldest temperature of the heating equipment, as appropriate. Temperature-indicating devices should be calibrated at the routine operating temperature of the refrigeration, cooling, or heating equipment against a known accurate standard thermometer upon installation and at least once a year thereafter, or more frequently, if necessary, to ensure their accuracy. Records required to be maintained under 21 CFR 123.8 of accuracy checks for temperature-indicating devices should specify the date, standard used, method used, results, and person performing the test. A temperature-indicating device that has a divided fluid column or that cannot be adjusted to the standard should be immediately repaired or replaced. b. Temperature-Recording Devices Temperature-recording devices should be installed where they can be easily read and the sensors for such devices should be installed to ensure that they accurately measure the warmest temperature of the refrigeration equipment and the coldest temperature of the heating equipment, as appropriate. Computerized storage of temperature data may be used in place of recorder thermometer charts if the use of such a system has been validated and can be shown to be substantially equivalent to the use of a temperature-recording device. Each temperature-recording device should be checked for accuracy at the beginning and end of each production day and adjusted as necessary to agree as nearly as possible with the reference temperature-indicating device. A record of these accuracy checks should be maintained that specifies the time, date, temperatures indicated by both devices before adjustment, corrective action taken, where applicable, and person performing the accuracy check. 8. Corrective Actions Under 21 CFR 123.7, whenever a deviation occurs at a critical control point, the processor shall segregate and hold the product until a review can be made to determine the effect of that deviation, and shall take corrective action as necessary. For cooked, ready-to-eat products, when a deviation occurs at a cooking or pasteurization critical control point, the processor should meet the requirements of Sec. 123.7 either by destroying the product; by fully reprocessing, where possible, that portion of the production involved, keeping full records of the reprocessing conditions; or by setting aside that portion of the product involved for further evaluation as to any potential public health significance. Such an evaluation should be made by a process authority and should be in accordance with procedures recognized by process authorities as being adequate to detect any unacceptable hazard to public health. Unless this evaluation demonstrates that the product had been given a thermal process that rendered it free of microorganisms of potential public health significance or, in the case of pasteurization, that resulted in the adequate reduction in numbers of microorganisms, the product set aside should be either fully reprocessed to correct the deficiency or destroyed. A record should be made of the evaluation procedures used and the results. Either upon completion of full reprocessing or after the determination that no significant public health hazard exists, that portion of the product involved may be shipped in normal distribution. Otherwise, the portion of the product involved should be destroyed. 9. Sanitary Zones In addition to the requirements of 21 CFR 123.10, sanitary zones should be established around areas in which cooked product is handled or stored. In such areas, objects and employees that have come into contact with waste, raw product, or other insanitary objects are excluded. Packaging material, equipment, employees, and in-process materials that enter a sanitary zone should be treated in a manner that will minimize the risk of the introduction of microorganisms. Air handling systems should be designed to minimize the risk of airborne contamination and to provide positive air pressure in the sanitary zone relative to the surrounding areas. Appendix B to Part 123--Scombroid Toxin Forming Species 1. General guidelines for Scombroid Toxin Forming Species. 2. Critical control points. 3. Receipt of raw materials critical control point. 4. Processing critical control point. 5. Additional critical control points. 1. General Guidelines for Scombroid Toxin Forming Species This Appendix provides guidance on how to meet the requirements of 21 CFR part 123, subpart A for fish and fishery products that consist in whole or in part of scombroid toxin forming species. These include tuna, bluefish, mahi mahi, mackerel, sardines, herring, kahawai, anchovies, marlin, and other species, whether or not of the family Scombridae, in which significant levels of histamine may be produced in the fish flesh by decarboxylation of free histidine as a result of exposure of the fish after capture to temperatures that permit the growth of mesophilic bacteria. The guidance focuses on preventing the formation of scombrotoxin, which can be harmful to humans, as a consequence of improper handling after capture, i.e., time and temperature abuse. 2. Critical Control Points Every processor who engages in processing other than, or in addition to, storing of fish or fishery products that consist in whole or in part of scombroid forming species, must ensure that neither decomposition leading to histamine formation, nor histamine formation, has occurred before receipt of such fish or fishery products. Processors must also ensure that neither decomposition leading to histamine formation, nor histamine formation, occurs as a result of inadequate handling practices by the processor. In order to prevent these hazards from occurring, Hazard Analysis Critical Control Point (HACCP) plans prepared in accordance with 21 CFR part 123, subpart A will typically identify and address the receipt of raw materials, as well as processing, as critical control points. In accordance with 21 CFR part 123, subpart A, processors shall identify in their HACCP plans how they will control hazards at critical control points. This appendix provides guidance on how to do so with respect to scombroid toxin forming species. 3. Receipt of Raw Materials Critical Control Point a. First Processor 1. On-board handling. The first processor to take ownership after harvest of fish and fishery products of scombroid toxin forming species should ensure that vessels supplying such fish have in place measures to ensure that the fish were rapidly brought to, and maintained at, an internal temperature of 40 deg.F (4.4 deg.C) or below, and were not held for a period of time sufficient to allow histamine formation to begin at the temperature at which they were held. The processor may determine the time and temperature history of the fish by requiring certification of the fishing method and on- board handling practices, and a time/temperature log from the harvesting vessel. The time/temperature log should record, for each lot of fish, the date of harvest, fishing method, temperature of the harvest water, and temperature history of the fish relating to the lowering of the internal temperature. The temperature history of the fish may be documented by controlling and recording the key aspects of the cooling and storage operation (e.g., refrigerated brine or seawater temperature, fish size, and container packing). For purposes of this guideline, a lot of fish is the fish in a vessel storage compartment (i.e., well, tote, or other container). The log should be sufficient to enable the processor to determine whether the fish were subject to conditions in the water after capture, on the harvesting vessel, or in storage, that could cause, or significantly contribute to, the formation of histamine in the fish. 2. Sampling and examination. The first processor, as described in section 3.a.1. of this Appendix, should subject a representative sample of fish in each lot from the vessel to an external organoleptic examination for decomposition and should record the results of the examination. A representative sample should provide at least 95 percent confidence that decomposition does not exist in more than 2.5 percent of the fish in the lot. If the number of fish from a vessel is small enough to permit an examination of each fish, e.g., because the weight of each fish is typically greater than 10 pounds, the processor is encouraged to examine each fish. i. Any fish that exhibits decomposition should either be rejected and not used for food, or reconditioned according to the processor's established procedures. Reconditioning should include, at a minimum, removal of all parts of the fish that exhibit any decomposition, organoleptic reexamination of the remaining fish flesh, and the performance of a histamine analysis on the remaining fish flesh. ii. If no decomposition in any fish in a lot is detected through organoleptic examination, the following should apply: A. If the time/temperature log as described in section 3.a.1. of this Appendix indicates that the conditions on the vessel were unlikely to cause, or significantly contribute to, the formation of histamine in the fish, all the fish from that lot may be further processed or enter commerce. B. If the time/temperature log as described in section 3.a.1. of this Appendix indicates that the conditions on the vessel were likely to cause, or significantly contribute to, the formation of histamine in the fish in a lot, or if no adequate time/temperature log is available, a histamine analysis should be made on a representative sample of fish from that lot. iii. If decomposition is detected in less than 2.5 percent of the fish from a lot, the following should apply: A. If the time/temperature log as described in section 3.a.1. of this Appendix indicates that the conditions on the vessel were unlikely to cause, or significantly contribute to, the formation of histamine in the fish in a particular lot, those fish from that lot found to have decomposition should be treated in accordance with section 3.a.2.i. of this Appendix. Other fish from that lot may be further processed or enter commerce. B. If the time/temperature log as described in section 3.a.1. of this Appendix indicates that the conditions on the vessel were likely to cause, or significantly contribute to, the formation of histamine in the fish in a particular lot, or if no adequate time/ temperature log is available, the processor should perform a histamine analysis on a representative sample of organoleptically acceptable fish from that lot. (However, if the processor elects to perform a histamine analysis on a representative sample of each lot of fish from the vessel before conducting an organoleptic analysis for decomposition because, for example, the processor received the fish in a frozen state, the histamine analysis does not have to be repeated based on results of subsequent organoleptic analysis.) iv. If decomposition is detected in more than 2.5 percent of the fish from a particular lot, the processor should perform a histamine analysis on a representative sample of organoleptically acceptable fish from that lot. 3. Histamine Findings. i. If any fish from a particular lot is found to have histamine above a defect action level or other regulatory level or limit for histamine established by FDA, the fish in that lot may not be used for food. ii. If any fish from a particular lot is found to have histamine below the defect action level or other regulatory level or limit for histamine established by FDA but above levels expected of fresh fish, the fish from that lot should enter commerce only if first immediately cooked to prevent histamine from increasing to unacceptable levels. b. Subsequent Processors 1. Processor evaluations. All subsequent processors who take ownership of fish and fish products of scombroid toxin forming species and who engage in processing other than, or in addition to, storage, should subject a representative sample each lot of such fish and fishery products to organoleptic evaluation for decomposition to determine whether decomposition occurred during transfer from the previous processor. Any fish that exhibits decomposition should be treated in accordance with section 3.a.2.i. of this Appendix. 2. Decomposition. A finding of any organoleptically detectable decomposition should result in the organoleptic examination of the entire lot. If decomposition is detected in more than 2.5 percent of the fish in the lot, the processor should perform a histamine analysis on a representative sample of fish from the lot. The results should be treated in accordance with section 3.a.3. of this Appendix. 4. Processing Critical Control Point. Products that are undergoing processing should not be exposed to ambient temperatures of 40 deg.F (4.4 deg.C) or higher for more than a cumulative total of 4 hours. Processors should ensure that this requirement is met by monitoring and recording, at least every 2 hours, the length of time that the product is exposed to temperatures of 40 deg.F (4.4 deg.C) or higher. 5. Additional Critical Control Points. The guidelines relating to cooked ready to eat fish and fishery products specified by Appendix A, sections 6 and 7 should also be applied to scombroid toxin forming species, where applicable. Appendix C to Part 123--[Reserved] Appendix D to Part 123--Product Integrity 1. General guidelines for product integrity. 2. Product integrity critical control points. 1. General Guidelines for Product Integrity This Appendix provides guidance on how a processor can use an HACCP-based approach to ensure that all fish and fishery products are in compliance with the economic adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act (sections 402(b) and 403, respectively). This guidance applies to controlling economic factors including the identity of species, weight, count and size, and the percentage of valuable constituents. These factors must be accurately represented on the label and labeling of a food. 2. Product Integrity Critical Control Points Hazard Analysis Critical Control Point (HACCP) plans prepared in accordance with subpart A of 21 CFR part 123 will typically include the following critical control points, as appropriate, that can be used to ensure the economic integrity of the product: a. Receipt of Raw Material A processor must ensure that the fish and fishery products that it receives are correctly identified as to species at the point of receipt into its processing facility. Methods used for identification upon receipt may include, but are not limited to: 1. Exams. Physical examination of the seafood species by qualified personnel; 2. Evaluations. Laboratory evaluation (e.g., protein chromatography); and 3. Acceptance of species identity as certified by a supplier under either a Limited or a General and Continuing Guaranty, as provided for by section 303(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 CFR 7.12 and 7.13). b. Labeling-Economic Value A processor must ensure that the finished product labels, labeling, and invoices accurately represent the weight, count, and size of the product, as well as the presence and amount of any valuable constituents. An example would be the handling of shrimp and breading material to make breaded shrimp. The processor must ensure that the shrimp has not been adulterated by the addition of water, and that the valuable constituents are present at levels that are consistent with FDA standards of identity (21 CFR part 161) and compliance policy guides. The processor thus should provide for monitoring of the level of the valuable constituents throughout receipt, processing, and distribution to ensure that: 1. Identification. The species is correctly identified by its common or usual name and is so represented on the label and labeling. Guidance in selecting the correct common or usual name of a species is provided by the FDA Fish List. Specific requirements are given in 21 CFR 101.18 and 21 CFR part 161. 2. Valuable constituents. The valuable constituents of the product are not omitted or abstracted from the product (e.g., breaded shrimp contains the required weight ratio of shrimp to breading and, if appropriate, shrimp of the size and weight specified on the label or labeling). 3. Substitution. No substance is substituted wholly or in part for the valuable constituent (e.g., through added water or glazing, or substitution of crab flavored surimi for crab meat in a product labeled as crab cake). 4. Damage or inferiority. Damage or inferiority is not concealed in any manner (e.g., through bleaching or coloring of product to conceal its true nature or condition of wholesomeness). 5. Product adulteration. No substance is added to, or mixed with, the product to increase its bulk or weight or to reduce its quality, or make it appear of better or greater value than it is (e.g., through adding water to a product by chemical or other means). PART 1240--CONTROL OF COMMUNICABLE DISEASES 2. The authority citation for 21 CFR part 1240 continues to read as follows. Authority: Secs. 215, 311, 361, 368 of the Public Health Service Act (42 U.S.C. 216, 243, 264, 271). 3. Section 1240.3 is amended by revising paragraph (p) to read as follows: Sec. 1240.3 General definitions. * * * * * (p) Molluscan shellfish. Any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the scallop or scallop product consists entirely of the shucked adductor muscle. 4. Section 1240.60 is amended by revising the section heading; by designating the existing text as paragraph (a) and adding the word ``molluscan'' before the word ``shellfish'' the two times that it appears; and by adding new paragraphs (b) and (c) to read as follows: Sec. 1240.60 Molluscan shellfish. * * * * * (b) All unshucked raw molluscan shellfish, that is all unshucked molluscan shellfish that has not been subject to a treatment sufficient to kill pathogens of public health significance, shall bear a tag that discloses the date and place they were harvested, type and quantity of shellfish, and by whom they were harvested, including the number assigned to the harvester by the shellfish control authority. Any raw molluscan shellfish that are found by FDA in interstate commerce without such a tag or label, or with a tag or label that does not bear all the required information, will be subject to seizure and destruction. (c) Shucked molluscan shellfish shall be subject to the same requirements as apply to molluscan shellfish that has not been shucked as provided in paragraph (b) of this section, except that, in lieu of a tag, the body of the container of shucked molluscan shellfish, shall bear a label that identifies the name, address, and certification number of the processor of the molluscan shellfish. Dated: January 21, 1994. David A. Kessler, Commissioner of Food and Drugs. Donna E. Shalala, Secretary of Health and Human Services. Note: The following appendix will not appear in the annual Code of Federal Regulations. Appendix 1--FDA Fish Fishery Products Hazard and Controls Guide Including Guidance on Smoked Fish FDA is in the process of developing guidance to, among other things, assist the seafood industry develop and implement HACCP systems. The guidance will be titled the ``FDA Fish and Fishery Products Hazard and Controls Guide.'' When a draft of the entire Guide is completed in the near future, FDA will publish a notice of availability in the Federal Register and invite public comment. FDA will revise the draft as warranted and then issue the first edition of the Guide. I. The Information Presented The selected portions of the draft Guide that are provided below are: Example 1. The Table of Contents. Example 2. One page each from the ``Vertebrate'' and ``Invertebrate Hazard and Control Lists.'' Together, these lists contain about 350 species of commercially marketed fish. Each list is in the form of a chart that directs the reader to one or more of the 10 numbered hazard and control descriptions elsewhere in the Guide for species-related hazards. For purposes of the Guide, species-related hazards are those that can occur in the environment or during harvest. Processors should find in the appropriate list the species they handle, then turn to those numbered hazard and control descriptions that are relevant to that species. Example 3. A sample of a species-related hazard and control description (Species-related Hazard and Control #1 (Chemical Contamination)). Each description explains a hazard and the measures available to control it, with an emphasis on HACCP controls such as critical control points, critical limits, monitoring procedures and frequencies, recordkeeping, and corrective actions. Some descriptions contain several control options. Example 4. One page from the ``Process-related Hazards and Controls List.'' For purposes of this Guide, process-related hazards are those that can occur because of the nature of the processing procedures and the finished product form. This list includes 20 types of finished products (e.g., cooked shrimp) and directs the reader to one or more of the 22 process-related hazard and control descriptions, which are located in the next part of the Guide. The process-related hazard and control descriptions are numbered. Some of them are further subdivided into lettered portions. Where the reader need only refer to a portion of a process-related hazard and control description, the list directs the reader to that portion by referring to a lettered part of the description. See below. Example 5. A sample of a process-related hazard and control description (``Process-related Hazard and Control #11'' (pathogen survival during pasteurization)). As with the species-related descriptions discussed above, each process-related description explains a hazard and the measures available to control it, with an emphasis on HACCP controls. Some of these descriptions are subdivided. For example, ``Process-related Hazard and Control No. 8,'' which is about temperature abuse, is subdivided into ``8a: Histamine,'' ``8b: Pathogens,'' and ``8c: Decomposition.'' Where the list in 4. above directs a reader to a number-letter combination, e.g., ``8b,'' it is to one of the subdivided portions of a description, in this case to the ``Pathogens'' material in Process- related Hazards and Controls #8. Example 6. A consolidated section for smoked and smoke-flavored fishery products. Example 7. A model HACCP plan. This is essentially a fill-in- the-blank model. Processors can use the materials in the hazards and controls descriptions and this model plan, to develop much if not all of their HACCP plans, depending on their circumstances. It must be remembered that these materials reflect a work in progress and are published to provide the public with a preview of the document. When the entire document is made available to the public in the near future, the selected portions published here may have been revised. To help processors and other interested persons to understand the guidance presented in the consolidated section on smoked fishery products, FDA will explain that guidance in the section that follows. II. Smoked Fishery Products Research conducted since FDA proposed the 1970 final rule shows that less stringent processing temperatures and lower water-phase salt content, with or without use of other inhibiting factors such as sodium nitrite, can provide an adequate margin of safety for hot- process products held in refrigerated storage (40 deg.F (4.4 deg.C) or lower). FDA has considered this research, and based on it, the agency is proposing a guidance setting forth what it tentatively finds are the minimum time, temperature, and salinity requirements to make a safe and marketable smoked fish product. Proposed TTS parameters are found in example 6 of this appendix. A. Raw Materials/Handling of Unprocessed Fish. The presence of microorganisms, including C. botulinum and L. monocytogenes, cannot be avoided in fresh-water fish and marine fish because they are present in the aquatic environment. Under certain conditions, the potential exists for the outgrowth of C. botulinum spores and toxin production (Refs. 148 through 152), as well as for an increase in the L. monocytogenes population (Ref. 143). To minimize microbial growth, fresh fish should be maintained at refrigerated temperatures close to 38 deg.F (3.3 deg.C) (Refs. 173 and 175). Although certain strains of C. botulinum are capable of growth at temperatures as low as 38 deg.F (3.3 deg.C), favorable growth media are necessary for a significant growth rate to occur at this temperature. For example, it has been shown that C. botulinum Type E requires 31 to 35 days before outgrowth and toxin production occurs in a beef stew media held at 38 deg.F. However, outgrowth and toxin production in a cooked meat medium held at 41 deg.F does not occur until after 56 days, demonstrating that less favorable growth media can significantly lower the rate of growth. Even in those cases where C. botulinum does grow and produce toxin, the laboratory conditions are generally more ideally suited to growth than those found in nonexperimental situations where less favorable growth environments prevail. Thus, while the growth of C. botulinum is not completely inhibited at 40 deg.F (4.4 deg.C), under the less than ideal conditions for its growth that are generally encountered in the processing of smoked fish, FDA has tentatively concluded that maintaining fresh fish at a maximum temperature of 40 deg.F, only 2 degrees above the temperature of complete growth inhibition, before and during processing will provide adequate protection against C. botulinum outgrowth. Moreover, 40 deg.F (4.4 deg.C) is consistent with the maximum temperature FDA has proposed in various guidelines, such as the Unicode (now called the Food Code) (53 FR 16472, May 9, 1988). Therefore, under proposed Sec. 123.10(a)(14), all raw fish that is to be smoked must be refrigerated until needed for processing (Ref. 175). Similarly, fish that are initially frozen need to remain in the frozen state until needed for processing (Refs. 161 and 25). When frozen fish are needed for processing, the thawing procedure must be carried out in a way that minimizes the opportunity for microbial growth (Refs. 161 and 171). The method used to thaw the fish must provide an environment that will inhibit the growth of C. botulinum and other microorganisms that pose a potential health hazard (Refs. 171 and 172). Thus, the fish should be thawed in a way that ensures that the internal temperature at the core of the fish does not exceed 40 deg.F (4.4 deg.C) (Refs. 171 and 172). Therefore, section 4.a. of Example 6 of this appendix, the agency suggests that this procedure be used in the thawing process. B. Manufacturing Operations Reduction of the potential health hazard from C. botulinum spore outgrowth and toxin production in smoked and smoke-flavored fish relies on the interrelationship of processing time, processing temperature, water-phase salt concentration in the loin muscle, and smoke (or constituents of smoke) deposition, combined with refrigerated storage (40 deg.F (4.4 deg.C) or lower) (see proposed Sec. 123.10(a)(14)) (Ref. 173). At one time, smoking and associated brining may have been an effective preservation method. With the changes in processing techniques that have occurred since the advent of refrigeration and in response to consumers' demands for products with certain organoleptic qualities, however, smoked fish products, either hot- or cold-process, have become perishable products that must be refrigerated and cannot be considered preserved foods (Ref. 173). The changes that have occurred, both in processing techniques and in organoleptic qualities, have resulted in products that are more moist and contain less salt. As a result, the two critical processing factors that affect the overall preservation and safety of the product have been altered. The processing time-temperature parameters have been decreased, and the water-phase salt content has been reduced (Ref. 173). Therefore, these products need to be maintained at refrigerated temperatures (40 deg.F (4.4 deg.C) or lower) or frozen immediately after processing to ensure the overall quality of these products (Ref. 173). 1. Brining/dry salting. Salt, as a preservative in smoked and smoke-flavored fish, is somewhat limited in its effectiveness because of the variability in salt uptake by fish flesh, even among fish in the same brining tank. Ventral muscle, which is thin, absorbs high levels of salt, while the thicker dorsal muscles absorb less salt, limiting the effectiveness of salt as a deterrent against spore outgrowth in that part of the fish. Equilibration techniques, such as two-stage brining, reduce variation in salt content within a fish and increase the preservative effect (Ref. 176). It is possible that salt-tolerant microorganisms of public health concern (such as strains of Staphylococcus) may grow during brining or after the dry salting process. Therefore, FDA is providing in section 5.c. and 5.e. in example 6 of this appendix that the brining and dry salting of fish be carried out at refrigerated temperatures, i.e., 40 deg.F (4.4 deg.C) or lower. Doing so will ensure that the environment in which brining is done, and in which fish are held after dry-salting, will inhibit the growth of salt-tolerant microorganisms that can cause a potential health hazard (Ref. 173). FDA recognizes that when fish are initially added to the brine, the temperature of the brine may increase. It is essential to this process that the brine be returned to refrigerated temperatures 40 deg.F (4.4 deg.C) or lower to reduce the opportunity of microbial growth and to ensure the overall quality of the product during the brining process (Refs. 175 and 182). Therefore, the agency is suggesting in section 5.d. of Example 6 of this appendix that the temperature of the brine not exceed 60 deg.F (16 deg.C) at the start of brining. To minimize the variation in salt content of the fish, the agency is recommending in section 5.f. of Example 6 of this appendix that only fish of the same species and of similar size and similar weight be brined in the same tank (Refs. 171 and 199). Because reuse of brine solutions is a possible route of microbial contamination of raw fish, the agency is providing in section 5.g. of Example 6 of this appendix that brines not be reused unless they have been processed in some way to return them to a microbiological quality equivalent to the original, unused brine made with potable water and food-grade salt. The agency is also providing in section 5.h. of Example 6 of this appendix that a processor may rinse the brined fish with fresh water to remove any unwanted excess salt on the exterior of the fish. 2. Drying. Fish that are to be processed as smoked or smoke- flavored fish are dried after brining to remove excess water and prevent dripping during smoking. The drying process, usually of several hours in duration, provides another opportunity for microbial growth. Therefore, to minimize the opportunity for microbial growth by reducing those conditions that would provide a favorable environment for such growth, the agency is providing in section 5.i. of Example 6 of this appendix that the presmoking drying step should be conducted in a refrigerated room (Ref. 46). 3. Smoking. Smoke deposition, like water-phase salt content, is very difficult to control. Constituents of smoke called ``inhibitory compounds'' (such as phenolic compounds) are reported to have a bactericidal effect (Ref. 177). Factors that affect the quantity of inhibitory compounds deposited on the fish surface and the degree of penetration by those compounds into the fish are the humidity in the smoking chamber, the temperature of smoking, and the air flow in the smoking chamber (Ref. 178). Decreased levels of inhibitory compounds reduce the preservative effect of the smoke and make dependence on these compounds inadvisable (Ref. 178). In general, smoked products are not shelf stable and must be either refrigerated at a temperature of 40 deg.F (4.4 deg.C) or lower or frozen immediately after processing (Refs. 43, 45, and 178). To promote uniform deposition of smoke, heat exposure, and dehydration, and to ensure that on completion of these processes, the fish do not contain any raw or wet sections that would create an environment favorable for microbial growth and spoilage, the agency is providing in section 5.j. of Example 6 of this appendix that fish should be arranged in the smokehouse chamber or oven so that they are not overcrowded or touching each other, and that only fish of like size and weight should be included in a single batch of fish for smoking. Liquid smoke, a solution of wood smoke that, when diluted, may be used to impart a smoke flavor to fish products, is often used as an alternative to generated smoke. Liquid smoke has been reported to have similar antibacterial properties to, and some advantages over, generated smoke (Ref. 26). It is easier to apply uniformly, and the inhibitory compounds penetrate further into the fish flesh (Ref. 26). Liquid smoke, generated smoke, or a combination of liquid smoke and generated smoke needs to be applied to all surfaces of fish to be smoked. Liquid smoke may be applied to the product before, at the commencement of, or during the process, while generated smoke needs to be applied to the fish during the first half of the process and longer if necessary (Refs. 178 and 179). If a combination of liquid smoke and generated smoke is used, the method for use of liquid smoke may be followed, and the generated smoke may be applied at any stage of the process (Ref. 26). The agency is providing for the use of liquid smoke alone or in combination with generated smoke in section 3.c.2. of Example 6 of this appendix to impart smoke flavor and antibacterial properties to the products. 4. Use of sodium nitrite. Use of sodium nitrite in smoked and smoke-flavored fish products is limited to the species listed in Sec. 172.175 (21 CFR 172.175) and to chubs in Sec. 172.177 (21 CFR 172.177). Section 172.175 permits the use of sodium nitrite as a preservative and color fixative in cured, smoked sablefish, salmon, and shad. However, it requires that the level of sodium nitrite in the final product not exceed 200 ppm. Use of sodium nitrite substantially reduces the level of salt necessary to inhibit outgrowth of C. botulinum type A and type E spores, although the levels vary because of the difference in heat resistance between the two types of spores (Ref. 179). The quantity of sodium nitrite necessary to achieve inhibition is affected by both the level of contamination and the resistance of the spores (Refs. 179 and 180). Refrigeration of the finished product at temperatures of 40 deg.F (4.4 deg.C) or below is necessary to retain the inhibitory characteristic gained through use of sodium nitrite (Ref. 179). Therefore, in accordance with the provisions of Secs. 172.175 and 172.177, the agency is proposing to provide for the use of sodium nitrite in the processing and packaging of smoked and smoke-flavored fish in section 5.a. and section 5.b. of Example 6 of this appendix. 5. Vacuum- and modified atmosphere-packaging. Vacuum packaging and other types of modified atmosphere-packaging (those in which the air in the package or container is replaced by one or more gases, in various concentrations, before the package is sealed) extend the shelf life of foods markedly. However, the anaerobic environment created in these types of packaging favors the outgrowth of C. botulinum spores and subsequent toxin production, and it inhibits growth of aerobic microorganisms that might otherwise serve as organoleptic indicators of spoilage (Refs. 180 and 182). Consequently, use of vacuum- or modified atmosphere-packaging demands strict adherence to temperature-controlled storage and distribution to reduce the opportunity for spore outgrowth and toxin production and to reduce the potential growth of other microorganisms of public health significance (such as L. monocytogenes). Two methods of reducing the potential public health hazard of vacuum or modified atmosphere packaged smoked, smoke-flavored, and salted fish products are: (1) To store and distribute the products frozen or, alternatively, (2) to use in-package heat processing followed by refrigeration. At freezer temperatures, outgrowth of spores of C. botulinum types B, E, and F is retarded (Refs. 171, 173, and 180). Type A does not grow below 50 deg.F (10 deg.C) (Refs. 179 and 180). Storage and distribution in the frozen state reduces the possibility that temperature abuse will occur. In-package heat processing, sometimes referred to as ``heat pasteurization,'' at temperatures in the range of 185 deg.F (85 deg.C) for 85 minutes to 198 deg.F (92 deg.C) for 55 minutes, inhibits outgrowth and toxin production by type E spores (Ref. 185). Longer exposure to processing temperatures is required for more heat resistant spores, such as types B and A (Ref. 185). In a study examining this method of packaging, samples of hot-process salmon steaks were injected with spores of nonproteolytic strains of C. botulinum types B and E (Ref. 185). The steaks were vacuum packaged, heat pasteurized, then incubated using different time-temperature combinations. The results of this research showed that closely controlled in-package heat processing extends the shelf life of the product, inactivates nonproteolytic C. botulinum types B, E, and F and other vegetative pathogens, and maintains product quality attributes. However, this process is more suitable for pieces, fillets, and steaks than for whole eviscerated fish because this process causes the flesh to separate from the backbone (Ref. 185). C. Specific Processing Conditions The various processing techniques used to produce smoked and smoke-flavored fish are affected by the interrelationship of the smoking, the method of smoke application, the time-temperature combinations used, and the water-phase salt content. A critical factor in determining alternative processing methods is the type of packaging utilized, specifically whether the product is air-packaged or vacuum-packaged. The following discussion sets out the various processing procedures that the agency has tentatively concluded will ensure the safety of hot-process smoked and smoke-flavored fish, and cold-process smoked and smoke-flavored fish. 1. Hot-process smoked and smoke-flavored fish. a. Air-packaged. Research data and industry practice show that a lower minimum water- phase salt content (3.5 percent or lower), in combination with lower processing temperatures (lower than 180 deg.F (82 deg.C)) than cited in the 1970 final rule for hot-process products are effective in inhibiting spore outgrowth and toxin production when the products are not vacuum-packaged and are held at refrigerated temperatures (40 deg.F (4.4 deg.C) or lower) (Refs. 24, 163, and 177). Research studies from the National Marine Fisheries Service and testimony presented at a public hearing held by the New York State Department of Agriculture and Markets on May 3, 1989, to establish a CGMP for the manufacture of smoked and smoke-flavored fish products, show that C. botulinum type E is inhibited in air-packaged smoked fish products when the water-phase salt content is at least 3.0 percent, and the processing internal temperature of the product is maintained at a minimum of 145 deg.F (63 deg.C) for at least 30 minutes (Ref. 180). In light of these findings, FDA is setting forth these processing parameters in Example 6 of this appendix to provide guidance on the safe manufacturing of these products. The agency is setting forth the following minimum T-T-S parameters for air-packed, hot-process smoked and smoke-flavored fish in section 5.a.1. of Example 6 of this appendix: Heating at an internal temperature of 145 deg.F (63 deg.C) for 30 minutes with a water-phase salt content of 3.0 percent in the finished product. b. Vacuum-packaged/modified atmosphere. For vacuum-packaged products, National Marine Fisheries Service research shows that processing temperatures in the range of 145 to 175 deg. F (63 to 80 deg.C) for hot-process smoked fish will inhibit C. botulinum type E when the water-phase salt content is greater than 3.5 percent (Refs. 26, 173, and 180). Based on this evidence, New York's CGMP included a procedure for processing vacuum-packaged smoked fish that specifies heating the fish to an internal temperature of 145 deg.F (63 deg.C) for 30 minutes, with a water-phase salt content of 3.5 percent (Ref. 25). The use of sodium nitrite in combination with sodium chloride significantly inhibits the outgrowth and toxin production of C. botulinum type E. Research data show that when the water-phase salt content and sodium nitrite content are at least 3.1 percent and 100 ppm, respectively, and the internal temperature of the fish is not less than 145 deg.F, the inhibitory effect on C. botulinum growth and toxin production greatly increases (Refs. 173 and 179). At higher processing temperatures, e.g., 180 deg.F (82 deg.C), a water-phase salt content of 3.0 percent or more inhibits toxin formation by C. botulinum type E (Ref. 163). Based on this information, the agency is setting forth the following T-T-S parameters for vacuum-packaged hot-process smoked and smoke-flavored fish in section 5.a.2. of Example 6 of this appendix: (1) Heating at an internal temperature of at least 145 deg.F (63 deg.C) for 30 minutes with a minimum water-phase salt content of 3.5 percent in the finished product, or (2) heating at an internal temperature of at least 145 deg.F (63 deg.C) for 30 minutes, with a minimum water-phase salt content of 3.0 percent, and a sodium nitrite content of 100 to 200 ppm (as permitted by the food additive regulations in Sec. 172.175) in the finished product, or (3) as described in Sec. 172.177 for smoked chub containing sodium nitrite. The agency points out that these processing parameters for vacuum-packaged hot-process smoked and smoke-flavored fish are minimums. Unless the comments on Example 6 of this appendix convince the agency otherwise, fish that have been processed at a lower temperature or with a lower water-phase salt level could provide the basis for regulatory action on the grounds that the product has been processed under conditions whereby it may have been reduced injurious to health and thus could represent a hazard for consumers. 2. Cold-process smoked and smoke-flavored fish. Cold-process smoked and smoke-flavored fish, by virtue of the temperatures used in processing, are not cooked because they are processed at temperatures lower than those that coagulate protein, i.e., 100 deg.F (38 deg.C) or lower. Because these temperatures are not high enough to inactivate C. botulinum spores, and because they provide a favorable environment for other food spoilage microorganisms, other inhibitive factors, such as higher salt content and sodium nitrite (where permitted by food additive regulations in Sec. 172.175) need to be used. The time and temperature relationship in the processing of cold- smoked and smoke-flavored fish is a critical factor in yielding a microbiologically safe and high quality finished product (Ref. 182). Modern establishments that cold-smoked fish generally process between 40 deg.F (5 deg.C) and 100 deg.F (38 deg.C) for 18 to 24 hours (Refs. 171 and 182). Based on the research data that are available and the requirements in the New York CGMP, the agency is proposing the following requirements for air-packaged and vacuum- packaged/modified atmosphere cold-process smoked and smoke-flavored fish (Refs. 25, 180, and 184). a. Air-packaged products. The agency is providing in section 5.a.3. of Example 6 of this appendix that air-packed, cold-process smoked and smoke-flavored fish should have a minimum water-phase salt content of: (1) 3.5 percent, or (2) 3.0 percent and contain 100 to 200 ppm of sodium nitrite in the finished product, or (3) 2.5 percent in the finished product if the product is frozen immediately after processing and cooling and is kept frozen throughout holding and distribution. The agency is providing that the finished product that contains a water-phase salt content of 2.5 percent should be frozen immediately and kept frozen to ensure the microbiological safety of the product, as well as to maintain the shelf-life of the finished product. As stated above, because these products are not cooked and contain a low water-phase salt content, these products may present a potential public health hazard because they provide an ideal environment for the outgrowth of C. botulinum spores and toxin production. Therefore, based on the discussion above, the agency is suggesting that air-packaged cold-process smoked and smoke-flavored fish be processed under one of the following sets of conditions: (1) A maximum 20-hour drying and smoking period with the temperature in the smoking chamber not exceeding 90 deg.F (32 deg.C) (section 5.a.3.i. of Example 6 of this appendix), or (2) a maximum 24-hour drying and smoking period with the temperature in the smoking chamber not exceeding 50 deg.F (10 deg.C) (section 5.a.3.ii. of Example 6 of this appendix) except that sablefish needs to be heated to a temperature not to exceed 120 deg.F (49 deg.C) for a period not to exceed 6 hours (section 5.a.3.iii. of example 6 of this appendix) (Refs. 25, 180, and 184). b. Vacuum-/modified atmosphere-packaged products. FDA is providing in section 5.a.4. of Example 6 of this appendix that cold- process smoked and smoke-flavored fish to be vacuum- or modified atmosphere-packaged should have a minimum water-phase salt content of: (1) 3.0 percent and contain 100 to 200 ppm of sodium nitrite in the finished product, or (2) 3.5 percent in the finished product when no sodium nitrite is used. The agency is also providing that vacuum-/modified atmosphere-packaged cold-process smoked and smoke- flavored fish should be processed under one of the following sets of conditions: (1) A maximum 20-hour drying and smoking period with the temperature in the smoking chamber not exceeding 90 deg.F (32 deg.C) (section 5.a.3.i. of Example 6 of this appendix), or (2) a maximum 24-hour drying and smoking period with the temperature in the smoking chamber not exceeding 50 deg.F (10 deg.C) (section 5.a.3.ii. of Example 6 of this appendix) (Refs. 25, 180, and 184). The agency again points out that these processing parameters for vacuum-/modified atmosphere-packaged cold-process smoked and smoke- flavored fish are minimums. Failure to adhere to these parameters could provide the basis for regulatory action because the product that results may be injurious to health and thus could represent a hazard to consumers. The agency believes that the proposed processing requirements for cold-process smoked and smoke-flavored products, air-packed and vacuum- or modified atmosphere-packaged, will produce a safe and commercially acceptable product. However, because less data and information are available for these products than for hot-process products, the agency is requesting specific comments, data, and information about these processing parameters and any alternative processing parameters that should be included in the guideline. 3. Cooling and storage of finished products. Rapid cooling and storage at temperatures of 40 deg.F (4.4 deg.C) or below are essential for all smoked, smoke-flavored, and salted fish products to minimize microbial growth. The exceptions are cold-process air- packaged products that contain a water-phase salt content of 2.5 percent, which should be frozen immediately after processing and remain frozen throughout distribution because of the lower water- phase salt content and lower processing temperatures that may provide an opportunity for food spoilage microorganisms to flourish during storage (see section 5.a.3. of Example 6 of this appendix) and the discussion above). Outgrowth of C. botulinum spores, types A and proteolytic B, and toxin production are inhibited at temperatures of 50 deg.F (10 deg.C) and lower. Spore types E and nonproteolytic B are completely inhibited at temperatures of 38 deg.F (3.3 deg.C) and lower (Refs. 174 and 185 through 188). At section 6 of Example 6 of the appendix, the agency is recommending specific time/temperature controls for processing after smoking. These proposed controls are the same as those proposed for after cooking in the cooked, ready-to-eat section of this document (Appendix A, section 6). A full discussion of the controls is provided in section VII.J.3. of this document. 4. Alternative processing parameters. As this preamble indicates, FDA has tentatively concluded that the TTS processing parameters reflected in this appendix are the minimum necessary to ensure that these products are free from botulinum toxin over their shelf life. FDA has also tentatively concluded that the T-T-S parameters, coupled with good sanitation practices, will also render these products listeria free. Nonetheless, the agency does not wish to discourage the development and use of alternative procedures that are capable of achieving the same outcome. Consequently, section 11 of Example 6 of this appendix calls for the use of alternative processing parameters when the user can demonstrate the following: (1) For botulism, zero toxin production slightly beyond the expected shelf life of the product, demonstrated through inoculated pack studies under normal and moderate abuse conditions and (2) for listeria, no detectable L. monocytogenes in the final product. The data demonstrating these outcomes would have to be available to FDA to enable the agency to determine whether they have been achieved. Example 6 of this appendix states that those data should be part of a processor's HACCP records. FDA asks for comment on whether a third-party scientific expert, or processing authority, should be involved in the development of the data that demonstrate the effectiveness of the alternative procedure. 5. Use of vacuum- and modified atmosphere-packaging. As explained above, vacuum- or modified atmosphere-packaged smoked, smoke-flavored, and salted fish products represent an increased public health hazard over conventionally packaged products because these types of packaging provide the ideal environment for spore outgrowth and toxin production. Based on the discussion above, the agency states in section 3 of Example 6 of this appendix that these types of packaging should be used only when: (1) As provided in section 5.a.2. of Example 6 of this appendix the product is a hot- process smoked or smoke-flavored product, is vacuum-packed or modified atmosphere-packed, and contains at least 3.5 percent water- phase salt in the finished product, or 3.0 percent salt and 100 to 200 ppm of sodium nitrite in the finished product (section 4.a.1. of Example 6 of this appendix); (2) as provided in section 5.a.4. of Example 6 of this appendix, the product is a cold-process smoked or smoke-flavored product, is vacuum-packed or modified atmosphere- packed, and contains at least 3.5 percent water-phase salt in the finished product or 3.0 percent salt and 100 to 200 ppm of sodium nitrite. The agency is providing in Appendix C, section 8.a. that all vacuum- or modified atmosphere-packaging should be conducted within the processing plant where the product is manufactured (Ref. 180). FDA considers this limitation appropriate to prevent any postprocessing contamination of the product from bacterial pathogens and to ensure that the fish will be packaged immediately after processing to protect its overall quality. 6. Process monitoring. Section 7 of Example 6 of this appendix, the agency is recommending specifications for temperature indicating and recording devices where they are recommended elsewhere in this appendix. These proposed specifications are the same as those proposed in Appendix A for cooked, ready-to-eat fishery products (Appendix A, section 7). A full discussion of these controls is provided in section VII.J.4. of the preamble to this document. Temperature indicating and recording devices are specifically recommended in section 5.j. and 5.k. of Example 6 of this appendix for the control of the smoking temperature. At section 5.b. of Example 6 of this appendix, the agency is recommending specific controls to ensure that the appropriate water- phase salt and sodium nitrate levels are achieved. The significance of these attributes has already been discussed in this document. In section 5.b. of Example 6 of this appendix, the agency recommends that a processor perform or obtain a study that shows that under certain processing conditions the desired water phase salt or sodium nitrite level will reliably be achieved. The processor should monitor those processing conditions identified by the study as having an impact on the ability of the product to achieve the desired level. The study should provide critical limits for each of the relevant processing conditions (e.g. maximum fish size, minimum soak time, minimum salt to product ratio). Because of the existence of numerous variables that affect the ability of fish to uniformly take up salt and sodium nitrite, it may be appropriate for a processor to perform periodic finished product water phase salt or sodium nitrite analyses as a verification step. The purpose of such analyses would be to identify any variables that have an impact on salt or nitrite absorption that were not identified by the study. 7. Corrective actions. At section 9 of Example 6 of this appendix, the agency is recommending corrective action procedures. These proposed procedures are the same as those proposed in the cooked, ready-to-eat section of this document (Appendix A, section 8). A full discussion of the procedures is provided in section VII.J.5 of the preamble to this document. 8. Sanitary zones. At section 10 of Example 6 of this appendix, the agency is recommending the institution of sanitary zones. This proposed control procedure is the same as that proposed in the cooked, ready-to-eat section of this document (Appendix A, section 9). A full discussion of the control procedure is provided in section VII.J.6 of the preamble to this document. To further ensure the safety of the product during distribution and storage, FDA is considering adopting specific package labeling requirements for smoked and smoke-flavored fish products to reduce the opportunity of temperature abuse of the finished product. The agency requests comments on whether it should require that the label of all shipping containers and retail packages state that the product is perishable, and, more specifically, that the product must be kept refrigerated. FDA tentatively finds that such labeling is extremely important to ensuring the safe handling of these products, and, therefore, it considers it likely that it will require this labeling in the final rule. The agency requests comment on whether it should do so. The agency also requests comment on whether, if it decides to require such a label statement, the statement should specify a temperature at which the product should be refrigerated (e.g. 40 deg.F (4.4 deg.C) or below). The agency is also considering requiring that the label of all frozen smoked products state that the product must remain frozen, that if the product needs to be thawed, it must be thawed at refrigerated temperatures, and that the product must not be refrozen. FDA has authority to adopt these labeling requirements under sections 201(n), 403(a), and 701(a) of the act because these sections require the inclusion of facts on the food label that are material with respect to consequences that may result from use of the product under conditions of use prescribed in the label or that are otherwise customary or usual. The agency requests comments on whether it is necessary to do so. EXAMPLE 1.--FDA Fish And Fishery Products Hazards And Controls Guide Table of Contents Section I: Status Purpose HACCP This Guide and How to Use It Section II: Table 1--Vertebrate Hazard and Control List Table 2--Invertebrate Hazard and Control List Species Related Hazards and Controls Nos. 1-10 No. 1 (Safety)--Chemical contamination other than methyl mercury No. 2 (Safety)--Methyl mercury No. 3 (Safety)--Natural toxins 3a Paralytic shellfish poisoning (PSP) 3b Neurotoxic shellfish poisoning (NSP) 3c Diarrheic shellfish poisoning (DSP) 3d Amnesic shellfish poisoning (ASP) 3e Ciguatera food poisoning (CFP) 3f Clupeotoxin 3g Chondrichthytoxin 3h Tetrodotoxin 3i Gempylotoxin No. 4 (Nonsafety)--Filth, extraneous materials or noxious substances No. 5 (Nonsafety)--Decomposition No. 6 (Safety)--Histamine No. 7 (Safety)--Food and color additives No. 8 (Nonsafety/safety): Parasites No. 9 (Safety)--Animal drugs No. 10 (Safety)--Pathogenic Microorganisms Section III: Table 3--Process Related Hazards and Controls List Process Related Hazards and Controls Nos. 1-22 No. 1 (Nonsafety)--Filth in dry ingredients No. 2 (Nonsafety)--Processing of dead crustaceans and mollusks No. 3 (Nonsafety)--Temperature abuse during raw material storage No. 4 (Safety)--Excessive water activity No. 5 (Safety)--Inadequate salt, sugar, and/or nitrite concentration No. 6 (Safety)--Pathogen survival during cook No. 7 (Safety)--Cross-contamination No. 8 (Safety/nonsafety)--Temperature abuse during processing of cooked products and raw molluscan shellfish No. 9 (Safety/nonsafety)--Temperature abuse during processing of noncooked products No. 10 (Safety)--Microbiological growth in batter No. 11 (Safety)--Pathogen survival during pasteurization No. 12 (Safety): Recontamination after pasteurization No. 13 (Safety/nonsafety)--Temperature abuse during final cooling No. 14 (Safety/nonsafety)--Temperature abuse during finished product storage No. 15 (Safety/Nonsafety)--Temperature abuse during finished product distribution No. 16 (Safety)--Metal inclusion No. 17 (Safety)--Food and color additives No. 18 (Nonsafety)--Short weight No. 19 (Nonsafety)--Species substitution No. 20 (Nonsafety)--Grade size misrepresentation No. 21 (Nonsafety)--Incorrect proportions No. 22 (Nonsafety)--Over breading Section IV: Finished Product Standards for Use in Verification Section V: Smoked and Smoke-Flavored Fishery Products Cooked, Ready-to-Eat Fishery Products Scombroid Toxin Forming Species Section VI: Model HACCP Plan Example 2.--Section II [Table 1--Vertebrate Hazard and Control List] ------------------------------------------------------------------------ Safety Non safety Market names Scientific names hazards hazards\1\ ------------------------------------------------------------------------ Aholehole................ Kuhlia spp. ....... 4, 5 Alewife/river herring.... Alosa spp. 1 4, 5, 8 Alfonsino/red bream...... Beryx spp. ....... 4, 5 Trachichthodes spp. ....... 4, 5 Amberjacks/yellowtail.... Seriola spp. 3e, 6 4, 5, 8 Anchovy/anchoveta........ Anchova spp. 1, 3f, 4, 5 Anchoviella spp. 6 4, 5 Cetengraulis spp. 1, 6 4, 5 Engraulis spp. 1, 6 4, 5 Stolephorus spp. 1, 6 4, 5 Aquaculture species...... Aquatic species, 1, 7, 4, 5, 8 (Including 8, 9 invertebrates, fishes, amphibians and reptiles) Angelfish................ Holacanthus spp. 3e 4, 5 Pomacanthus spp. ....... 4, 5 Argentine/queenfish...... Argentina elongata ....... 4, 5 Barracouta............... Thrysites atun ....... 4, 5 Barracuda................ Sphyraena spp. 3e 4, 5 Bass..................... Ambloplites spp. 1, 9 4, 5, 8 Micropterus spp. 1, 9 4, 5, 8 Morone spp. 1, 9 4, 5, 8 Stereolepis gigas 1, 9 4, 5, 8 Synagrops bellus 1, 9 4, 5, 8 Bass, sea................ Acanthistius 8 4, 5, 8 Brasilianus ....... 4, 5, 8 Centropristis spp. ....... 4, 5, 8 Dicentrachus labrax ....... 4, 5, 8 Lateolabrax ....... 4, 5, 8 Japonicus ....... 4, 5, 8 Paralabrax spp. ....... 4, 5, 8 Pranthias furcifer ....... .......... Polyprion spp. ....... .......... ------------------------------------------------------------------------ \1\See Table of Contents for key to hazards. Reminder: See process hazard tables beginning on p. 70 for hazards that apply to your product. TABLE 2.--Invertebrate Hazard and Control List ---------------------------------------------------------------------------------------------------------------- Market names Scientific names Safety hazards\1\ Non safety hazards\1\ ---------------------------------------------------------------------------------------------------------------- Abalone...................... Haliotis spp................. 1, 3a, 3b, 3c, 3d....... 4, 5 Aquacultured invertebrates... All species (Coelenterates, 1, 3a, 3b, 3c, 3d, 7, 9, 4, 5, 8 Molluscs, Crustacea, and 10. Echinoderms). Arkshell..................... Anadara subcrenata Arca spp.. 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Carpet Shell........... Tapes spp.................... 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Bentnose............... Macoma nasuta,............... 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Butter................. Saxidomus spp................ 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Calico................. Macrocallista maculata....... 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Clovis................. Tapes virginea............... 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Geoduck................ Panopea spp.................. 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Hard................... Arctica islandica, 3a, 3b, 3c, 3d, 10...... 4, 5 Meretricinae spp. Venus mortoni. Clam, Hardshell/Quahog....... Protothaca thaca............. 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Littleneck............. Protothaca staminea 1, 3a, 3b, 3c, 3d, 10... 4, 5 Protothaca tenerrima, Tapes philippinarum. Clam, Manila................. Tapes semidecussata.......... 1, 3a, 3b, 3c, 3d, 10... 4, 5 Clam, Pismo.................. Tivela stultorum............. 1, 3a, 3b, 3c, 3d, 10... 4, 5 ---------------------------------------------------------------------------------------------------------------- \1\See Table of Contents for key to hazards. Reminder: See process hazard tables beginning on p. 70 for hazards that apply to your product. Example 3 Species-Related Hazards and Controls No. 1 Hazard No. 1 (Safety)--Chemical Contamination Other Than Methyl Mercury Contamination of Raw Material at Receipt with Pesticides, Radioactivity, Toxic Elements, and Industrial Chemicals, Derived From the Harvest Area. Hazard Statement Fish and molluscan shellfish may be harvested from waters that are exposed to varying amounts of environmental contaminants. Industrial chemicals, pesticides, and many toxic elements may accumulate in fish at levels that can cause public health problems. Concern for these contaminants primarily focuses on fish and shellfish harvested from fresh water, estuaries, and near-coastal waters rather than from the open ocean. Pesticides and herbicides used near aquaculture operations or for other purposes may contaminate fish and fishery products. Federal tolerances or action levels are established for some of the most toxic and persistent contaminants that are found in fish and fishery products shipped in interstate commerce. (These contaminants and their corresponding limits are listed below.) When products exceed these limits, FDA can seize the contaminated fish and fishery products. States often use the limits for deciding whether to issue consumption advisories or to close or classify waters for harvesting. Molluscan shellfish waters are controlled by the State Shellfish Control Agency (SSCA) or the equivalent in foreign countries that have Memoranda of Understanding with the United States that permit them to export molluscan shellfish to this country. If local or regional contaminants are not covered by federal limits, contact local health departments to decide if contaminant levels in fish and fishery products are of public health concern. The control measures provided in this section are appropriate for the control of methyl mercury contamination in fish, where such contamination is the result of industrial contamination in a harvest area. Recommended controls for the problem of open ocean species, such as swordfish and shark, concentrating methyl mercury from their diet and its diffuse presence in the environment are provided in the ``Mercury'' hazard section. Critical Control Point: Receiving There are five options for control at this critical control point. Option 1 Where the firm receives wild caught fish, other than molluscan shellfish, directly from the fisher or from a supplier that has credible knowledge of the harvest area location (e.g., a tender or related company that pools fish from various fishers), the following applies: Control Measures 1. Find out the harvest area location for each lot or batch from the fisher upon receipt. 2. Find out whether the harvest area is closed to fishing by foreign, Federal, State or local health authorities due to known instances of chemical contamination. 3. Reject fish that have been caught in a closed area. Example ABC Fish Co. has contacted the State Department of Health and learned that the Long River is closed to commercial harvest above Lookout Point, including its tributaries, due to the presence of chlordecone (Kepone<SUP>TM). The species affected are croaker, bluefish, and striped bass. ABC Fish Co., which processes these species, will reject any of the listed species originating from the area. Frequency 1. For finding out the location: each lot or batch. 2. For finding out whether the harvest area is closed: before accepting fish from a new area and after that at least quarterly. 3. For rejecting fish: each lot or batch that does not meet the critical limit. Critical Limits Zero tolerance for fish (i.e., accept no fish) harvested from areas closed by foreign, State, or local health authorities due to chemical contamination. Records A record for each lot or batch that shows the harvest area for the fish. Record may be the receipt from the fisher, if it shows the harvest area, or it may be a notation on another record of the location of harvest for each lot or batch. The description of the location should be clear enough to show that the fish were harvested from an area that is open to harvesting. Longitude and latitude may be necessary (e.g., for open ocean harvesting). Corrective Actions Destroy or recall product that fails to meet the critical limit. Any critical limit deviation should cause a timely assessment by management to: Decide whether the process or HACCP plan needs changing to reduce the risk of recurrence of the deviation, and to take appropriate followup action. Option 2 Where the firm receives raw fish, other than molluscan shellfish, directly from the aquacultural or maricultural producer or from a supplier that has credible knowledge of the harvest area location (e.g., a tender or related company that pools fish from various aquaculturists), the following applies: Control Measures 1. Find out the harvest area location for each lot or batch of aquacultured fish. 2. Find out the potential for chemical contamination before receipt of the product. This can be done by obtaining or reviewing the results of analysis of soil, water, and raw fish samples, as needed. Monitor agricultural and industrial practices in the aquacultural or maricultural production area. 3. Reject fish that have been grown in an area where uses of agricultural or industrial chemicals are likely to have caused contamination of the growing and harvesting environment or where soil, water, or fish sample results show chemical contamination. Example ABC Fish Co., which receives pond-raised catfish from the Long River delta area, screens potential pond sites either directly or by obtaining results of the aquaculturists' analyses of soil and water samples. The samples are analyzed for pesticides, PCB's, dioxins, and petrochemicals. Either ABC Fish Co. representatives visit each pond to assess the potential for ongoing chemical contamination, or information is obtained from the U.S. Department of Agriculture Extension Service about the use of pesticides and herbicides near each pond. Where there is a potential for pond contamination, annual samples are collected and analyzed for the same contaminants. Fish that come from contaminated or suspect ponds are rejected. Frequency 1. For finding out the location: each lot or batch. 2. For learning the potential for contamination: before accepting fish from a new growing area, and annually, after that if there is a potential for ongoing contamination of the growing area. 3. For rejecting fish: each lot or batch that does not meet the critical limit. Critical Limits Zero tolerance for fish (i.e., accept no fish) produced in an area where uses of agricultural or industrial chemicals are likely to have caused contamination of the growing and harvesting environment. Records Record that shows the production area for each lot of raw material. Records describing the assessed risk of chemical contamination for all producers. Corrective Actions Destroy or recall product that fails to meet the critical limit. Any critical limit deviation should cause a timely assessment by management to: Learn whether the process or HACCP plan needs modification to reduce the risk of recurrence of the deviation, and take appropriate followup action. Option 3 Where the firm receives fish, other than molluscan shellfish, from someone other than the fisher, aquacultural producer, or a supplier that has credible knowledge of the harvest area location (e.g., a transportation company that pools fish from various fishers or aquaculturists), the following applies: Control Measures 1. Periodically monitor the incoming fish for environmentally persistent organochlorine pesticides which have the potential to be present in the fish. These should include, but are not limited to: DDT and its degradation products (DDE, TDE), chlordane, and heptachlor, also similar chlorinated industrial chemicals, such as PCB's and dioxins. Sampling should represent all suppliers (i.e., three samples per supplier per year). 2. Reject all shipments from suppliers that provide fish that exceed the critical limits unless convincing evidence can be obtained that only acceptable harvest or growing areas are now being used. Example ABC Fish Co. receives brown shrimp from an interstate seafood transportation company. The carrier, which buys the shrimp directly from the fishers, makes no effort to learn the harvest location. ABC Fish Co. collects three samples per supplier per year and sends them to a contract laboratory for pesticide screening. When positive test results are obtained, the firm stops using that supplier. Frequency 1. For sampling incoming fish: three times per supplier per year. 2. For rejecting fish: each lot or batch that does not meet the critical limit. Critical Limits All limits are for the edible portion of the fish product, and are based on wet weight: <bullet> Aldrin plus dieldrin, chlordane, endrin, heptachlor plus heptachlor epoxide, and chlordecone (Kepone<SUP>TM): 0.3 ppm in edible portion (except chlordecone in crabmeat 0.4 parts per million(ppm)) (CPG 7141.01); <bullet> DDT plus TDE plus DDE: 5 ppm (CPG 7141.01); <bullet> Mirex: 0.1 ppm (CPG 7141.01); <bullet> Toxaphene: 5.0 ppm in edible portion (CPG 7141.01); <bullet> PCB's: 2 ppm [CPG 7108.19 and CFR 109. 30 (A)]; <bullet> Methyl mercury: 1 ppm (CPG 7108.07). Records Records of analytical results from the firm's own laboratory or contract laboratory(s). Corrective Actions Destroy or recall product that fails to meet the critical limit. Any critical limit deviation should cause a timely assessment by management to: Learn whether the process or HACCP plan needs changing to reduce the risk of recurrence of the deviation, and take appropriate followup action. Option 4 Where the firm receives inshell molluscan shellfish, the following applies: Control Measures 1. Find out the harvest area location from the harvester's tag on the containers of shellfish for each lot or batch of shellfish. 2. Check the harvester's state commercial fishing license or compare the dealer's certification number to those listed in the most current edition of the ``Interstate Certified Shellfish Shippers List (ICSSL).'' If the dealer is not listed, check for certification with the SSCA or equivalent. 3. Find out whether the harvest area is closed (i.e. classified as prohibited) to fishing by a SSCA or equivalent due to chemical contamination. 4. Reject molluscan shellfish harvested from a closed (i.e., classified as prohibited) area, or delivered by an unlicensed harvester or uncertified dealer, or those not properly tagged. Example The ABC Fish Co. distributes clams, muscles, and oysters to restaurants. The shellfish are received from other processors. The firm examines the labels of the containers in each lot to learn the name, address, and certification number of the last processor. This information is compared to the ICSSL to confirm that the product is from a certified processor. Containers from uncertified processors and inadequately labeled containers are rejected. Contact the State Department of Health to confirm certification for unlisted processors. Frequency 1. For finding out the location: each lot or batch. 2. For checking licenses and certification: each lot or batch. 3. For finding out whether the harvest area is closed: before accepting shellfish from a new area and as often after that as necessary to ensure accuracy. 4. For rejecting molluscan shellfish: each lot or batch that does not meet the critical limit. Critical Limits Zero tolerance for molluscan shellfish (i.e., accept no molluscan shellfish) harvested from areas closed (i.e. classified as prohibited) by a SSCA or equivalent due to chemical contamination. Zero tolerance for molluscan shellfish (i.e., accept no molluscan shellfish) delivered by a harvester that is unlicensed or a processor that is not certified by a SSCA or equivalent. Zero tolerance for molluscan shellfish (i.e., accept no molluscan shellfish) that do not bear a tag on each container that contains the following information, at a minimum: harvester's name, address, the harvester number assigned by the SSCA or equivalent; date of harvest; location of harvest by state and site; type and quantity of shellfish. Bulk shipments should be identified by a bill-of-lading that contains the same information. Records A record for each lot or batch that shows the information from the harvester tag or bill of lading, including: name of harvester, address, identification number, the date of harvest, location of harvest by state and site, quantity and type of shellfish. Corrective Actions Destroy or recall product which fails to meet the critical limit. Any critical limit deviation should cause a timely assessment by management to: learn whether the process or HACCP plan needs changing to reduce the risk of recurrence of the deviation, and take appropriate followup action. Option 5 Where the firm receives shucked molluscan shellfish, the following applies: Control Measures 1. Find out the name, address, and certification number of the last processor from the containers of shucked molluscan shellfish in each lot or batch. 2. Compare the dealer's certification number to those listed in the most current edition of the ``Interstate Certified Shellfish Shippers List'' (ICSSL), which is published monthly. If the dealer is not listed, check for certification with the SSCA or equivalent. 3. Reject molluscan shellfish not from a dealer certified by a SSCA or equivalent, packed in containers not bearing the name, address, and certification number of the last processor. Example ABC Fish Co. receives shucked oysters from other processors. The firm examines the labels of the containers in each lot to learn the name, address, and certification number of the last processor. This information is compared to the current ICSSL to confirm that the product is from a certified processor. Containers from uncertified processors and inadequately labeled containers are rejected. The firm contacts the State Department of Health to confirm certification for unlisted processors. Frequency 1. For finding the certification number: each lot or batch. 2. For finding out if the processor is certified: each lot or batch. 3. For rejecting uncertified molluscan shellfish: each batch that does not meet the critical limit. Critical Limits Zero tolerance for molluscan shellfish (i.e., accept no molluscan shellfish) from an uncertified processor. Zero tolerance for molluscan shellfish (i.e., accept no molluscan shellfish) packed in containers that do not list the name, address, and certification number of the last processor. Records Record for each lot or batch that shows the date of receipt, type and quantity of shellfish, and name and certification number of the last processor. Corrective Actions Destroy or recall product that does not meet the critical limit. Any critical limit deviation should cause a timely assessment by management to: Learn whether the process or HACCP plan needs changing to reduce the risk of recurrence of the deviation, and take appropriate followup action. Example 4 Section III Table 3.--Process-Related Hazards and Controls List Products ---------------------------------------------------------------------------------------------------------------- Finished product Safety hazards Nonsafety hazards ---------------------------------------------------------------------------------------------------------------- Cooked crustacean meat, cooked crustacean 3b\1\, 6\2\, 7, 8b, 13b, 14b, 15b 2\4\, 3c\1\, 8c, 13c, 14c, sections, whole crustaceans (except shrimp). 16\3\, 17. 15c, 18, 19 Cooked shrimp................................ 6, 7, 8b, 13b, 14b, 15b, 16\3\, 3c, 8c, 13c, 14c, 15c, 18, 20 17. Surimi-based analog products................. 6, 7, 8b, 13b, 14b, 15b, 16, 17.. 1, 8c, 13c, 14c, 15c, 18, 21 Pasteurized crustacean meat and pasteurized surimi-based analog products (in addition to hazards identified above). 11, 12........................... .............................. Coldsmoked fish (including spreads and dips). 3a\5\b, 5, 7, 9a\5\b, 13a\5\b, 3c, 9c, 13c, 14c, 15c, 18, 19 14a\5\b, 15a\5\b, 16\3\, 17. Hotsmoked fish (including spreads, dips, 3a\5\, 5, 6, 7, 8a\5\b, 13a\5\b, 3c, 8c, 13c, 14c, 15c, 18, 19 sausages, and jerkies). 14a\5\b, 15a\5\b, 16\3\, 17. ---------------------------------------------------------------------------------------------------------------- \1\This hazard applies only if a cooked raw material or molluscan shellfish is used. \2\This hazard does not apply to blue crab (Callinectes sapidus), dungeness crab (Cancer magister), or king crab (Paralithodes spp.) and golden crab (Lithodes aequispina). \3\This hazard applies only to those products that are mechanically produced. \4\This hazard applies only to live raw material. \5\This hazard applies only for scombriod-type species. See Vertebrate Hazard List (Hazard 6-Histamine). Example 5 Process-Related Hazard and Control No. 11 Hazard No. 11 (Safety)--Pathogen Survival During Pasteurization Hazard Statement Survival of Clostridium botulinum (C. botulinum type E) or other microorganisms of public health concern, through the pasteurization process is a food safety hazard for cooked, ready-to-eat products packed in hermetically sealed containers and held refrigerated. Pasteurization is a process applied to a fish or fishery product after that fish or fishery product has been placed in a final, hermetically sealed package. The process involves the application of sufficient heat (or other processes) for a sufficient time to cause the reduction of microorganisms of public health concern to levels that, under normal conditions of storage, are unlikely to cause disease. C. botulinum type E is a pathogenic microorganism that may be found in fish and fishery products. Botulism is a severe type of food poisoning caused by the ingestion of foods containing the potent neurotoxin formed during the growth of C. botulinum. C. botulinum type E can grow and produce toxin at temperatures as low as 3.3 deg.C (38 deg.F), and must, therefore, be eliminated from the hermetically sealed container during the pasteurization process. Pasteurized products that are stored, distributed, and displayed in the frozen state, and are so labeled, are not similarly at risk, and need not be subjected to the constraints of these control measures. For there to be assurance that the pasteurization step effectively eliminates the microorganisms of public health significance (e.g., C. botulinum type E), a minimum acceptable process should be scientifically established. This requires expert knowledge of thermal process calculations. Procedures used in establishing the minimum thermal process should be those that are generally recognized and accepted. Sometimes, thermal death time, heat penetration, and inoculated pack studies will be necessary to establish the minimum process. In other instances, existing literature is sufficient to provide the processor with a minimum process. In either case, characteristics of the process and/or the product will necessarily affect the ability of the cook step to effectively eliminate the microorganisms of public health significance. Such factors should be considered in the establishment of the process. Where control of those factors is necessary to consistently achieve that goal, the process authority should specify these to the processor. It is necessary that the pasteurizing equipment be designed and operated so that every unit of product receives the established minimum process. This will require that a competent process authority, who is thoroughly familiar with the dynamics of heat transfer in processing equipment, evaluate the design and operation of the type of equipment used by the processor. Sometimes temperature distribution studies will be necessary to establish the adequacy of the equipment. In other instances existing literature will be sufficient to establish the adequacy of the equipment. Critical Control Point: Pasteurization Control Measures 1. Make sure that the pasteurization process that is being used was designed to ensure an appropriate reduction in the numbers of viable microorganisms of public health concern. The adequacy of the pasteurization process should be established by a process authority. The pasteurization process that is being used should meet any factors of the process or of the product that are identified by the process authority as critical to achieving pathogen destruction. At a minimum, these critical factors should include pasteurizing times and temperatures. 2. Make sure that the pasteurization equipment being used is properly designed and operated to deliver the process established by the process authority. The engineering specifications of the equipment being used (e.g., pipe sizes, flow rates, loading pattern) should meet or exceed that of the equipment evaluated by a process authority. 3. Deliver the pasteurization process in a way that there is no deviation from the minimum established pasteurization critical factors. 4. Monitor the pasteurization temperature with a temperature recording device (i.e., temperature recorder). The temperature recorder should be installed where it can be easily read and the sensor for the device should be installed to ensure that it accurately measures the coldest temperature of the pasteurizing equipment. The temperature recorder must show a continuous record of the process. Computerized storage of temperature data may be used for a temperature recorder chart if the use of such a system has been validated and can be shown to be equivalent to the use of a temperature recorder. 5. Check the accuracy of each temperature recorder at the beginning and end of each production day and adjust it as necessary to agree as nearly as possible with a temperature indicating device (mercury-in-glass thermometer or equivalent device). The thermometer should be installed where it can be easily read and placed to ensure that it accurately measures the coldest temperature of the pasteurizing equipment. 6. Calibrate the thermometer at the pasteurizing temperature against an accurate standard thermometer. This should be done when the thermometer is installed and at least once a year after that, or more frequently, if necessary, to ensure its accuracy. 7. Monitor the length of the pasteurization cycle. 8. Monitor other critical factors (e.g., initial temperature, container size, product formulation) at the start of each shift or when the product changes during a shift. Example The ABC Crab Co. produces pasteurized crabmeat. The pasteurization process being used has been established by the university extension service (a process authority). The process provided by the extension service includes limits on how to stack the canned product into the pasteurizer, the process temperature, and the length of time needed to achieve proper pasteurization. The pasteurization equipment being used by ABC Crab Co. is at least equivalent to that described by the information received from the extension service. It is equipped with both a mercury-in-glass thermometer and a recording thermometer. The recording thermometer is compared to the mercury-in-glass thermometer during each pasteurization cycle. It is adjusted as necessary to meet the critical limit. The mercury-in-glass thermometer is calibrated at an independent laboratory every 6 months. The temperature of each pasteurization cycle is controlled to meet the critical limits using the mercury-in-glass thermometer and the length of each cycle is controlled using a wall clock. The loading of the cans is checked before starting each batch. Frequency 1. For making sure that the pasteurization process was properly established: before using a pasteurization process. 2. For making sure that the pasteurizing equipment is properly designed: before using pasteurizing equipment. 3. For properly delivering the process: each lot or batch. 4. For monitoring the temperature: each lot or batch. 5. For checking the accuracy of the temperature recorder: at the beginning and end of each production day. 6. For calibrating the thermometer: at installation and at least annually after that. 7. For monitoring the length of the pasteurizing cycle: each lot or batch. 8. For monitoring other critical factors: as often as necessary to achieve control. Critical Limits Zero tolerance for product produced with a deviation from the minimum established pasteurization process, including such critical factors as time, temperature, initial temperature, container size, and product formulation. The temperature-indicating device should agree within 1 deg.C (<plus-minus>2 deg.F) of the National Institute of Standards and Technology (NIST) traceable thermometer. The temperature recording device should be adjusted to agree as nearly as possible, but never to be higher, than the temperature indicating device. Records A record that describes the results of a scientific evaluation, conducted by a process authority, of the adequacy of the pasteurizing process. Such document may consist of, but is not limited to, a letter from a process authority, articles in scientific journals, or Federal, State, or local government regulations or advisories. A record that describes the results of a scientific evaluation, conducted by a process authority, which applies to the design and operation of the type of equipment used by the processor. A record for each lot or batch that shows the results of the pasteurization process. The records should include: the time of day that the pasteurization temperature is achieved; the time of day that the pasteurization cycle ends; the time of day that the product is placed in the water; and, as appropriate, the product size, belt speed (continuous pasteurizer), the temperature at the time that the processing starts, and any other factors of the process or of the product that are identified by the process authority as being critical to achieving pathogen reduction. Temperature recorder charts or computerized temperature data storage. A record of calibration for thermometers that specify the date, standard against which the thermometers were compared (NIST- traceable thermometer), procedure used, results, and person performing the test. A record of accuracy checks for the temperature recorder that specifies the time, date, temperatures shown by the thermometer and temperature recorder before adjustment, the corrective action taken, and person performing the accuracy check. Records of process evaluation by the process authority, where deviations from critical limits occurred. Corrective Actions When there has been a failure to maintain appropriate temperature, time, or other critical factors of the process or of the product, within the critical limits, the affected product should be: <bullet> destroyed; <bullet> reprocessed to eliminate the hazard, keeping full records of the processing conditions; or, <bullet> segregated and held until an evaluation can be made to determine the effect of a deviation. The evaluation should be made by a process authority following recognized procedures. Unless the evaluation shows that the product has received adequate pasteurization, the product should be destroyed or reprocessed to eliminate the hazard. Indicating or recording thermometers that cannot be adjusted to within the critical limits should be repaired or replaced. A thermometer that has a divided fluid column should be immediately repaired or replaced. Any critical limit deviation should cause a timely assessment by management to: Learn whether the process or HACCP plan needs changing to reduce the risk of recurrence of the deviation, and take appropriate followup action. Example 6 General Guidance for Smoked and Smoke-Flavored Fishery Products 1. General guidance for smoked and smoke-flavored fishery products 2. Definitions 3. Critical control points 4. Thawing 5. Brining and smoking 6. Post-smoking 7. Temperature monitoring equipment 8. Packaging 9. Corrective actions 10. Sanitary zones 11. Alternative parameters 1. General guidance for smoked and smoke-flavored fishery products This section provides consolidated guidance on how to meet the requirements of subpart A of 21 CFR part 123, for the processing of smoked and smoke-flavored fishery products. This guidance involves processing procedures for the control of the microbiological hazards to which these products are particularly susceptible. The guidance does not apply to finnan haddie, smoked cod fillets, smoked scotch kippers, or other smoked fish that are cooked before being consumed, because these products will be heated to destroy any potential toxins or pathogens. The guidance also does not apply to smoked fishery products that are packaged in hermetically sealed containers, processed to destroy spores of nonproteolytic C. botulinum types B, E, and F, and stored and distributed refrigerated, in the same container. These products are covered by Appendix A relating to Cooked, Ready-to-Eat fishery products. In addition, the guidance does not cover environmental or other hazards that might occur before the processor takes possession of its product or raw materials. (Guidance on these hazards may be found in a separate guidance document for all fish and fishery products issued by FDA.) 2. Definitions a. Cold-process smoked or cold-process smoked-flavored fish means the finished food prepared by subjecting forms of smoked fish and smoke-flavored fish to heat for a period of time that does not coagulate the protein. b. Hot-process smoked or hot-process smoke-flavored fish means the finished food prepared by subjecting forms of smoked fish and smoke-flavored fish to sufficient heat for a sufficient period of time to coagulate protein throughout the fish. c. Liquid smoke means an aqueous solution of wood smoke which, when suitably diluted, may be used to impart a smoke flavor to fish products. d. Loin muscle means the longitudinal quarter of the great lateral muscle of the fish that is free from skin, scales, visible blood clots, bones, gills, and from the nonstriated part of such muscle, which part is known anatomically as ``the median superficial muscle.'' e. Modified atmosphere-packaging means the food-packaging technique in which the air in a package or container is replaced by one or more gases, in various concentrations, before sealing. The purpose of this type of packaging is to extend the refrigerated shelf life of the product by limiting microbial growth or detrimental chemical changes in the food. f. Smoked-flavored fish means fish that is prepared by treating it with salt (sodium chloride) and then imparting to it the flavor of smoke by other than the direct action of smoke, such as immersing it in a solution of liquid smoke. This paragraph does not alter the labeling requirements under Sec. 101.22 of this chapter. g. Smoked fish means fish that is prepared by treating it with salt (sodium chloride) and then subjecting it to the direct action of smoke from burning wood, sawdust, or similar material. h. Sodium nitrite content means the concentration in parts per million of sodium nitrite in the loin muscle of the finished product as determined by the method of analysis for sodium nitrite in the ``Official Methods of Analysis of the Association of Official Analytical Chemists,'' 15th ed. (1990). i. Vacuum-packaged means the food-packaging technique in which the air in a package or container is removed before sealing. j. Water-phase salt content means the percent salt (sodium chloride) in the finished product as determined by the method of analysis for water-phase salt on the ``Official Methods of Analysis of the Association of Official Analytical Chemists,'' 15th ed. (1990). It is measured in the loin muscle of whole, dressed fish and in the thickest part of cuts of fish. 3. Critical Control Points Hazards Analysis Critical Control Point (HACCP) plans prepared in accordance with subpart A of 21 CFR part 123, will typically identify and address the following critical control points: a. Raw material thawing b. Brining or dry salting c. Drying d. Smoking e. Cooling after smoking f. Post-smoke processing, if any g. Final product cooling h. Refrigerated storage i. Distribution In accordance with subpart A of 21 CFR part 123, processors shall identify in their HACCP plans how they will control hazards at critical control points. The measures in sections 4 through 11 of this guidance are suitable for HACCP plans. 4. Thawing Thawing should be carried out in as rapid a manner as possible, so that the internal temperature at the core of the fish does not exceed 40 deg.F (4.4 deg.C). 5. Brining and smoking a. Products covered by this guidance should be subjected to one of the following processes: (1) Hot-process smoked or hot-process smoke-flavored fish to be air packaged needs to be heated to a continuous internal temperature of at least 145 deg.F (63 deg.C) throughout each fish for a minimum of 30 minutes, and brined to contain not less than 3.0 percent water-phase salt in the finished product (except that smoked chub containing sodium nitrite as provided for in Sec. 172.177 of this chapter must be processed as described in that section); or (2) Hot-process smoked or hot-process smoked-flavored fish to be vacuum packaged, modified atmosphere packaged, or controlled atmosphere packaged, needs to be heated to a continuous internal temperature of at least 145 deg.F (63 deg.C) throughout each fish for a minimum of 30 minutes. It also needs to be brined to contain not less than 3.5 percent water-phase salt in the finished product. However, where sodium nitrite is present at not less than 100 parts per million (as permitted by Secs. 172.175 and 172.177 of this chapter) the water-phase salt content in the finished product should not be less than 3.0 percent; or (3) Cold-process smoked fish and cold-process smoke-flavored fish to be air-packaged should be brined or dry salted to contain at least 3.5 percent water-phase salt in the finished product. However, when such fish contains not less than 100 parts per million sodium nitrite, it should contain not less than 3.0 percent water-phase salt in the finished product. When cold-process smoked fish or cold- process smoked-flavored fish to be air-packaged is frozen immediately after smoking and cooling, and remains frozen throughout subsequent storage and distribution, it should contain not less than 2.5 percent water-phase salt in the finished product. Cold smoked and cold smoke-flavored fish to be air packaged should be processed under one of the following sets of conditions: (i) The temperature in the smoking chamber does not exceed 90 deg.F (32 deg.C) during a drying and smoking period that does not exceed 20 hours, or (ii) The temperature in the smoking chamber does not exceed 50 deg.F (10 deg.C) during a drying and smoking period that does not exceed 24 hours. (iii) For sablefish, the temperature in the smoking chamber does not exceed 120 deg.F (49 deg.C) during a drying and smoking period that does not exceed 6 hours; or (4) Cold-process smoked fish and cold-process smoke-flavored fish, to be vacuum packaged, modified atmosphere packaged, or controlled atmosphere packaged should be brined to contain at least 3.0 percent water-phase salt in the finished product and not less than 100 parts per million of sodium nitrite (where permitted by Secs. 172.175 and 172.177 of this chapter) and should be processed as described in section 5(a)(3)(i) or (a)(3)(ii) of this Appendix. If sodium nitrite is not used, the water-phase salt content in the finished product should be at least 3.5 percent. b. Brining and dry salting operations should be conducted in a manner that will consistently result in the water phase salt content or sodium nitrite level (where permitted by Secs. 172.175 and 172.177 of this chapter) recommended by section 5.a. of this Appendix. This should be achieved by conducting or obtaining a study that establishes that the appropriate salt content or sodium nitrite level is always met under prescribed processing conditions. The study should establish the limits of significant variables that could affect the ability of the product to reach the appropriate levels. These variables may include product size, product condition, soak time, soak temperature, salt-to-water ratio, and product-to- brine ratio. An adequate study should consist of at least three processing runs under the prescribed processing conditions. In this case, the processor should monitor and record the prescribed processing conditions identified by the study at least every 2 hours. c. The brining of all fish should take place in a refrigerated area at 40 deg.F (4.4 deg.C) or lower. d. The temperature of the brine should not exceed 60 deg.F (15.6 deg.C) at the start of brining. The temperature of the brine at the start of the each brining process should be determined and recorded. e. For dry salting, the fish should be returned to a refrigerated area of 40 deg.F (4.4 deg.C) or lower immediately after the application of the salt. f. Different species of fish and fish of dissimilar size and weight should not be mixed in the same brining tank. g. Brines should not be reused unless they are subject to a process that effectively returns them to a microbiological condition equivalent to the original, unused brine made with potable water and food-grade salt. h. Fish may be rinsed with potable water after brining. i. Drying of a product to be cold-smoked should be carried out in a refrigerated area at 40 deg.F (4.4 deg.C) or below. j. Smoking operation. (1) Fish should be arranged without overcrowding and without touching each other within the smokehouse oven or chamber to permit uniform smoke absorption, heat exposure, and dehydration. Fish smoked in the same smoke chamber load should be of relatively uniform size and weight. (2) Liquid smoke, generated smoke, or a combination of liquid smoke and generated smoke needs to be applied to all surfaces of the product. Liquid smoke may be applied to the product before, at the beginning, or during the process. If only generated smoke is to be used, it needs to be applied to the fish during the first half of the process. If a combination of liquid smoke and generated smoke is used, the generated smoke may be applied at any stage of the process. k. Each smoking chamber should be equipped with a temperature recording device to indicate the temperature of the air and of the fish within the smoking chamber. Additionally, each chamber should be equipped with a temperature indicating device to indicate the temperature of the air within the smoking chamber. l. During hot-smoking or cold-smoking, a temperature recording device should be used to monitor both the internal temperature of the fish and the ambient temperature of the smoking chamber. The internal temperature readings should be obtained by inserting probes from the temperature recording device into the thickest flesh portion of three or more of the largest fish in the smoking chamber. The temperature from the slowest heating fish should be considered the processing temperature. 6. Post-Smoking a. Cooling after smoking. After smoking, the product needs to be rapidly cooled to minimize recontamination. Continuous cooling from 140 deg.F (60 deg.C) to achieve an internal temperature of 70 deg.F (21.1 deg.C) or below within 2 hours and an internal temperature of 40 deg.F (4.4 deg.C) or below within an additional 4 hours, unless processing after smoking as described in section 6.b. of this Appendix, occurs during either of these time periods, will effectively minimize recontamination. Other time/temperature parameters may also be effective. Processors should ensure that the cooling parameters are met by either: (1) Monitoring. Monitoring and recording internal product temperatures at least every 2 hours; or (2) Studies. i. Conducting or obtaining a study that establishes that appropriate cooling temperatures are always met under prescribed processing conditions. The study should establish the limits of significant variables that could affect the rate of cooling. These variables may include product size, ambient air temperature, and amount of product in the cooler. An adequate study should consist of at least three processing runs under the prescribed processing conditions; and ii. Monitoring and recording the prescribed processing conditions as identified by the study in section 6.a.2.i. of this Appendix at least every 2 hours. b. Processing after smoking. Products that will receive processing after smoking should not be exposed to ambient temperatures of 40 deg.F (4.4 deg.C) or higher for longer than a cumulative total of 4 hours after smoking. If they are exposed to such temperatures for more than 4 hours, unacceptable recontamination is the likely result. Processors are required to regularly monitor and record the length of time that the product is exposed to temperatures above 40 deg.F (4.4 deg.C) under 21 CFR 123.8. FDA recommends that such monitoring and recording be done at least every 2 hours. c. Final product cooling. To avoid microbiological hazards for perishable finished products, the internal temperature of the finished product should be 40 deg.F (4.4 deg.C) or below within 4 hours of placement in a finished product container. Processors should either conduct: (1) Monitoring. Monitor and record internal product temperatures at least every 2 hours; or (2) Studies. i. Conduct or obtain a study that establishes that the internal temperature of the finished product will always be 40 deg.F (4.4 deg.C) or below within 4 hours of placement in a finished product container under prescribed processing conditions. The study should establish the limits of significant variables that could affect the rate of cooling. These variables may include product size, ambient air temperature, and amount of product in the cooler. An adequate study should consist of at least three processing runs under the prescribed processing conditions; and ii. Monitoring and recording the prescribed processing conditions as identified by the study in section 6.c.2.i. of this Appendix at least every 2 hours. d. Refrigerated storage. (1) In-process products. Refrigeration units that are being used to store in-process products or finished products must operate at a temperature of 40 deg.F (4.4 deg.C) or below in accordance with 21 CFR 123.10(a)(14). (2) Temperature devices. Units should be equipped with both a temperature-indicating device and a temperature-recording device. In lieu of a temperature-recording device, a processor may equip a refrigeration unit with a high temperature alarm or a maximum- indicating thermometer and maintain a temperature log that notes temperature with such frequency as is necessary to achieve control. e. Distribution. All perishable finished products should be distributed in a manner that ensures that the internal temperature is maintained at 40 deg.F (4.4 deg.C) or below. 7. Temperature Monitoring Equipment Where reference is made in this Appendix to temperature- indicating devices and temperature-recording devices, the following conditions should apply: a. Temperature-indicating devices. Temperature-indicating devices should be installed where they can be easily read and located to ensure that they accurately measure the warmest temperature of the refrigeration equipment and the coldest temperature of the smoking equipment, as appropriate. Temperature- indicating devices should be calibrated at the routine operating temperature of the refrigeration, cooling, or smoking equipment against a known accurate standard thermometer upon installation and at least once a year thereafter, or more frequently, if necessary, to ensure their accuracy. Records of accuracy checks for temperature-indicating devices required to be maintained under 21 CFR 123.8 should specify the date, standard used, method used, results, and person performing the test. A temperature-indicating device that has a divided fluid column or that cannot be adjusted to the standard should be immediately repaired or replaced. b. Temperature-recording devices. Temperature-recording devices should be installed where they can be easily read and the sensors for such devices should be installed to ensure that they accurately measure the warmest temperature of the refrigeration equipment and the coldest temperature of the smoking equipment, as appropriate. Computerized storage of temperature data may be used in place of recorder thermometer charts if the use of such a system has been validated and can be shown to be substantially equivalent to the use of a temperature-recording device. Each temperature-recording device should be checked for accuracy at the beginning and end of each production day and adjusted as necessary to agree as nearly as possible with the reference temperature-indicating device. A record of these accuracy checks should be maintained that specifies the time, date, temperatures indicated by both devices before adjustment, corrective action taken, where applicable, and person performing the accuracy check. 8. Packaging a. Vacuum- or modified atmosphere-packaging should be conducted only within the facilities in which the product is produced. b. Permanently legible code marks should be placed on each finished product package and shipping container. These marks should identify the plant where the product was packed and the date of packing. 9. Corrective Action Under 21 CFR 123.7, whenever a deviation occurs at a critical control point, the processor is required to segregate and hold the product until a review can be made to determine the effect of that deviation and take corrective action as necessary. For smoked and smoke-flavored fishery products, when a deviation occurs at a brining or smoking critical control point, the processor should meet the requirements of Sec. 123.7 either by destroying the product; by fully reprocessing, where possible, that portion of the production involved, keeping full records of the reprocessing conditions; or by setting aside that portion of the product involved for further evaluation as to any potential public health significance. Such an evaluation should be made by a process authority and should be in accordance with procedures recognized by process authorities as being adequate to detect any unacceptable hazard to public health. Unless this evaluation demonstrates that the product had been rendered safe for its intended use, the product set aside should be either fully reprocessed to correct the deficiency or destroyed. A record should be made of the evaluation procedures used and the results. Either upon completion of full reprocessing or after the determination that no significant public health hazard exists, that portion of the product involved may be shipped in normal distribution. Otherwise, the portion of the product involved should be destroyed. 10. Sanitary Zones In addition to the requirements of 21 CFR 123.10, sanitary zones should be established around areas in which a smoked product is handled or stored. In such areas, objects and employees that have come into contact with waste, raw product, or other insanitary objects are excluded. Packaging material, equipment, employees, and in-process materials that enter a sanitary zone should be treated in a manner that will minimize the risk of the introduction of microorganisms. Air handling systems should be designed to minimize the risk of airborne contamination into sanitary zones and to provide positive air pressure in the sanitary zone relative to the surrounding areas. 11. Alternative Parameters A processor of smoked or smoke-flavored fishery products may use parameters other than those provided in Appendix C, section 5.a., if those parameters will achieve the following, as demonstrated by adequate scientific studies: (1) For botulism, zero toxin production in the product through a time period slightly beyond the shelf life of the product, demonstrated through inoculated pack studies under normal and moderate abuse conditions, and (2) For listeria, no detectable Listeria monocytogenes in the final product. A processor using alternative parameters should have on file, subject to the requirements of 21 CFR 123.8(d), a description, including the results of, the scientific studies. Example 7 Section VI Model HACCP Plan Establishment Name----------------------------------------------------- Establishment Address-------------------------------------------------- Mailing Address-------------------------------------------------------- Date and Authorization of HACCP Plan(s) Activation: Product---------------------------------------------------------------- Critical Control Point------------------------------------------------- 1. What is the hazard at this critical control point? 2. Describe your control measures. 3. What is your frequency of control? 4. What are your critical limits? 5. What records are kept of control measures? 6. What corrective action will you take when the product fails to meet the critical limits? [FR Doc. 94-1592 Filed 1-21-94; 4:31 pm] BILLING CODE 4160-01-P