8
Seafood Surveillance and Control Programs

ABSTRACT

This chapter considers the questions of how well existing governance efforts address and move to mitigate the risks in consuming seafood that have been identified thus far in this report. The chapter describes and evaluates efforts by federal and state regulatory authorities and private industry to minimize the level of seafood risk.

At the federal level, seafood safety falls primarily under the authority of the Food and Drug Administration (FDA). The FDA serves as the lead agency in setting and enforcing regulatory limits for seafood products. However, other federal agencies also play an important role. The Environmental Protection Agency is responsible for setting or recommending pesticide limits in seafood, and the National Marine Fisheries Service operates the Voluntary Seafood Inspection Program. The Centers for Disease Control is responsible for the collection and evaluation of data characterizing the source of seafood-borne illness.

Individual states play a dominant role in the control of seafood-borne risk. State public health, environmental protection, and resource management agencies have developed programs designed to mitigate that risk. The actions of state governments are fundamental to seafood safety because of the important differences in consumption and contaminant levels across regions of the country.

Furthermore, the international community, as well as individual foreign states, have developed practices and protocols impacting the regulation of seafood safety in the United States. The impacts of all these governance efforts are described and evaluated in this chapter.

INTRODUCTION

The purpose of this chapter is twofold. An initial effort is made to describe and characterize existing programs under the authority of federal, state, and local governments; other public bodies; and private organizations designed to ensure the safety of seafood consumed by the U.S. public. Based on an analysis of those programs, this report provides an overall evaluation of their effectiveness. Such a



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Seafood Safety 8 Seafood Surveillance and Control Programs ABSTRACT This chapter considers the questions of how well existing governance efforts address and move to mitigate the risks in consuming seafood that have been identified thus far in this report. The chapter describes and evaluates efforts by federal and state regulatory authorities and private industry to minimize the level of seafood risk. At the federal level, seafood safety falls primarily under the authority of the Food and Drug Administration (FDA). The FDA serves as the lead agency in setting and enforcing regulatory limits for seafood products. However, other federal agencies also play an important role. The Environmental Protection Agency is responsible for setting or recommending pesticide limits in seafood, and the National Marine Fisheries Service operates the Voluntary Seafood Inspection Program. The Centers for Disease Control is responsible for the collection and evaluation of data characterizing the source of seafood-borne illness. Individual states play a dominant role in the control of seafood-borne risk. State public health, environmental protection, and resource management agencies have developed programs designed to mitigate that risk. The actions of state governments are fundamental to seafood safety because of the important differences in consumption and contaminant levels across regions of the country. Furthermore, the international community, as well as individual foreign states, have developed practices and protocols impacting the regulation of seafood safety in the United States. The impacts of all these governance efforts are described and evaluated in this chapter. INTRODUCTION The purpose of this chapter is twofold. An initial effort is made to describe and characterize existing programs under the authority of federal, state, and local governments; other public bodies; and private organizations designed to ensure the safety of seafood consumed by the U.S. public. Based on an analysis of those programs, this report provides an overall evaluation of their effectiveness. Such a

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Seafood Safety broad-based evaluation is necessary to ensure a reasonable understanding of all governance and management programs currently in place, as well as some measure of protection for the U.S. seafood consuming public. This report recognizes that the question of seafood safety is being addressed by a network of governmental and nongovernmental efforts. The committee's evaluation attempts to incorporate as comprehensive an approach as possible in order to develop a realistic characterization of seafood safety. The organization of this evaluation is designed to reflect as reasonably as possible this complex programmatic effort. The effort addresses both those programs carried out by federal administrative agencies and the responsibilities taken on by various state or local governments and the seafood industry. Further, in recognition of the international and interdependent nature of seafood commerce, efforts related to seafood safety carried out by other countries and by international economic and scientific organizations are also characterized. RESPONSIBILITIES AND PROGRAMS OF THE FEDERAL GOVERNMENT A number of federal agencies are involved in regulation of seafood (Martin, 1990). The primary federal agency with responsibility for the assurance of seafood safety is the U.S. Department of Health and Human Services' Food and Drug Administration (FDA). The agency houses a wide range of programs devoted to the research and management of seafood product safety. The FDA derives its authority over such programs primarily through two statutes: (1) the Federal Food, Drug and Cosmetic Act (FFDCA: 21 U.S.C. 301 et seq.), and (2) the Public Health Service Act (PHSA: 42 U.S.C. 262, 294 et seq.). Under the FFDCA, the FDA is assigned responsibility to ensure that seafood shipped or received in interstate commerce is "safe, wholesome, and not misbranded or deceptively packaged" (FDA, 1988d). Under the PHSA, FDA is empowered to control the spread of communicable disease from one state, territory, or possession to another. To carry out these statutory mandates, FDA has developed a series of regulatory and research programs described below. Regulatory authority for seafood safety is partially shared, within the present federal system, with two other regulatory actors. The Environmental Protection Agency (EPA) is most fundamentally involved in setting and recommending regulatory guidelines for pesticides. The EPA also provides assistance to FDA in identifying the range of residual chemical contaminants that pose a human health risk and are most likely to accumulate in seafood. The National Marine Fisheries Service of the Department of Commerce conducts the Voluntary Seafood Inspection Program. The role and responsibilities of both these agencies are detailed further below. Other federal regulators are also responsible for seafood promotion and quality. However, although programs in the Departments of Agriculture, Interior, and Defense may enhance seafood safety, such efforts should be viewed as ancillary to the larger federal efforts described below.

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Seafood Safety Standards and Guidelines The FDA is granted primary authority to set and enforce allowable levels of contaminants and pathogenic microorganisms in seafood, and has developed a number of regulatory guidelines designed to reduce public health risk. Section 402(a) of the FFDCA provides the FDA with its most broad-based power in controlling contaminants in seafood. Under this provision, FDA may control the production and trade of any "adulterated" seafood product. Under the FFDCA [Sec. 402(a)(1)] a food is deemed adulterated if "it bears or contains any poisonous or deleterious substance which may render it injurious to health. …" The FDA has historically used three related strategies to determine whether or not a seafood product should be deemed adulterated. If significant and reliable toxicological data are available, the agency will set a formal "tolerance" that identifies a limit above which the food is deemed to be injurious (FFDCA, Sec. 406). A formal tolerance identifies the amount of a given substance or organism that must be present for an enforcement action or seizure to be initiated. If a product contaminant exceeds a tolerance level, FDA may automatically remove that product from interstate commerce. However, when toxicological data are scanty or conflicting, when additional data are being developed, or when other conditions are changing rapidly, the promulgation of formal tolerance may be deemed inappropriate. In such instances the agency can promulgate "action levels" [the authority to set such levels is defined in FDCA, Sections 306, 402(a) and 406] which, according to the agency, are designed to provide prosecutorial guidance. Action levels are not binding on the agency or industry, and FDA can recommend prosecution regardless of whether the action level is exceeded. If FDA recommends prosecution, then it must establish in court that the product is injurious to health. Although the primary authority for the designation of formal tolerances and action levels resides with FDA, the agency shares authority with EPA regarding the regulatory limits for pesticides. With the creation of EPA, and by way of the Presidential Reorganization Order No. 3 of 1970 (DOC, 1970), primary responsibility for the regulation of pesticides in food was transferred to EPA. Under present agreements, EPA holds sole responsibility for setting formal tolerances in seafood that are then enforced by FDA. For pesticide action levels, EPA submits a recommendation to FDA for enforcement. However, lacking a formal tolerance or action level, FDA may still act on an adulterated product by providing sufficient evidence that the product constitutes a problem for public health. These three approaches are detailed below. Tolerances According to FDA policy and a general interpretation of the U.S. Administrative Procedures Act (APA: 5 U.S.C. 551 et seq.), the setting of a formal tolerance requires (1) significant and reliable scientific evidence of the public health impacts of the specified tolerance level, and (2) a formal application of the notice-and-comment procedures enumerated in the APA. To date, FDA has specified only one formal tolerance designed specifically to mitigate human health impacts in seafood, that is, the 2.0-parts-per-million (ppm) tolerance for total polychlorinated biphenyls (PCBs). The

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Seafood Safety FDA has developed other tolerances for food, but none that are directly related to seafood safety. Action Levels Although FDA has used the vehicle of formal tolerances, setting regulatory guidelines for food, including seafood, has most often proceeded through the use of action levels. Unlike the establishment of tolerances, action levels do not require FDA to proceed through formal notice-and-comment rule making. Thus, setting seafood regulatory guidelines most often occurs via action levels. However, action levels have been the focus of significant controversy in recent years. Until recently, FDA had developed a set of enforcement practices wherein tolerances and action levels were enforced with equivalent rigor. In fact, there was little difference in the certitude with which the agency would characterize and respond to an adulterated product. Indeed, the equivalence of these two types of regulatory limits was articulated by FDA. For example, FDA published a regulation [21 CFR 109.4 (1986)] that stated [A]n action level for an added poisonous or deleterious substance … may be established to define the level of contamination at which food will be deemed adulterated. An action level may prohibit any detectable amount of substance in food. Thus, in practice, there was no functional difference between an action level and a tolerance. However, in 1987 the legal status of FDA action levels was refined and clarified by the U.S. Court of Appeals for the District of Columbia Circuit. A suit was brought against FDA by a consortium of consumer groups and private organizations, known collectively as the Community Nutrition Institute (CNI), that challenged FDA regulation of aflatoxin in corn [Community Nutrition Institute vs. Young: 818 F. 2d 943 (D.C. Cir. 1987)]. FDA had set an action level for corn at 20 parts per billion (ppb). In addition, the agency allowed aflatoxin-contaminated and noncontaminated corn to be mixed, provided the mixture did not exceed the 20-ppb action level. The court did recognize that action levels have the benefit of apprising the regulated community of the agency's intention, as well as informing the exercise of discretion by agents and officers in the field; however, the court held [818 F. 2d 949 (D.C. Cir. 1987)] that [o]ur limited holding is that the current action levels are treated as substantive rules by FDA and, as such, can only be permitted if notice-and-comment procedures are employed. If it so chooses, FDA could proceed by action levels that are purely policy statements. But in order to do so, FDA must avoid giving action levels the kind of substantive significance that it now so plainly attaches to them. Because of the Community Nutrition Institute decision, FDA reevaluated its action level policy. The FDA has also published a new regulation that allows substantive rules, called regulatory limits, to be established by formal notice-and-comment rule making [55 Fed. Reg. 20,782 (May 21, 1990)]. The regulatory limit will establish the level of an unavoidable added poisonous or deleterious substance that renders a food adulterated within the meaning of the FFDCA. A regulatory limit will be established when (1) the substance cannot be

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Seafood Safety avoided by current good manufacturing practices (GMPs); (2) there is no tolerance established for the substance in the particular food; and (3) there is insufficient information by which a tolerance may be established for the substance, or technology changes that may affect the appropriateness of a tolerance appear reasonably possible [55 Fed. Reg. 20,782 (May 21, 1990)]. Although FDA has established a formal mechanism for creating regulatory limits for unavoidable deleterious or poisonous contaminants, the agency also recognizes that it will maintain the action levels. However, FDA has stressed that action levels are not binding on the agency or industry [55 Fed. Reg. 20,782 (May 21, 1990)]. As such, FDA has the discretion to recommend court enforcement regardless of whether the product is within the action level. Likewise, FDA can forgo recommending court action when a product exceeds an action level. Although action levels are no longer binding on the FDA, they are valuable because they provide significant guidance and focus to field personnel who direct monitoring and inspection programs that contribute to the identification of adulterated seafood products. Specific action levels have been developed for several contaminants in seafoods and seafood products. The list of action levels for microbial and natural toxin contaminants includes Escherichia coli in fresh and frozen crabmeat, parasites in finfish, and paralytic shellfish poison in clams, mussels, and oysters. A complete list of current action levels for microbial and natural toxin contaminants, and of the measurement methods used to determine them, is presented as Table 8-1. Additionally, FDA has published a set of action levels for residual chemical contaminants, including pesticides. As noted earlier, the list of 12 chlorinated pesticides represents a cooperative effort between FDA and EPA. Although EPA retains the right to generate formal tolerances for pesticides, its strategy has been to communicate pesticide limits in terms of action levels. According to EPA personnel, this approach allows the agency to continue to monitor pesticide levels in the environment and to modify the action level based on monitoring results. Although a broad-based reevaluation of current pesticide action levels is underway by EPA, they provide guidance for acceptable levels in seafood products. The complete list of FDA action levels for residual chemical contaminants is presented in Table 8-2. Seafood Deemed Injurious to Public Health The FDA need not avail itself of either a formal tolerance or an action level to make a determination of adulteration. It may monitor for any contaminant that might produce a product injurious to public health. The most effective statement of existing FDA strategy addressing the development of regulatory guidelines was that recently presented by the agency's Acting Commissioner, during a hearing before Congress on February 7, 1990: In the absence of a national standard, FDA brings individual enforcement actions to establish that the amount of the contaminant present in the food may render it injurious to health. This broad legal standard in the Federal Food, Drug, and Cosmetic Act applies across the board to all foods under FDA's jurisdiction and its application is the norm in food adulteration cases. Whether a national standard does or does not exist, the Agency can still take action against potentially unsafe products. This is an

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Seafood Safety TABLE 8-1 Food and Drug Administration Compliance Policy Guides (CPG) Relating to Seafood Safety Microbiological Contamination Title: Crabmeat-Fresh and Frozen-Adulteration with Filth, Involving the Presence of the Organism Escherichia coli. Action Level: E. coli of at least 3.6 per gram (g). Calculation by most probable number (MPN) methodology. CPG 7108.02. Effective October 1, 1982. Title: Langostinos-Frozen, Cooked-Adulteration by Bacteriological Contamination. Action Level: (1) Coliform density greater than 20/g (MPN) in 20% of samples; (2) E. coli density greater than 3.6/g (MPN) in 20% of the subsamples; or, (3) coagulasepositive staphylococci density greater than 3.6/g in 20% of the subsamples or, aerobic plate count (at 35°C) greater than 100,000/g as a geometric average of all the subsamples. CPG 7108.09. Effective October 1, 1980. Title: Raw Breaded Shrimp-Microbiological Defect Action Levels Action Level: Actionable if one or more of the following conditions are met: 1. Aerobic Plate Counts (35°C)-The mean log of 16 units of finished product breaded shrimp collected prior to freezing is greater than 5.00 (i.e., geometric mean greater than 100,000/g) and exceeds the mean log of 16 units of stock shrimp by more than twice the standard error of their difference (2 SED). 2. E. coli-The mean log of 16 units of finished product breaded shrimp collected prior to freezing is greater than 0.56 (i.e., geometric mean greater than 3.6/g) and exceeds the mean log of 16 units of stock shrimp by more than twice the standard error of their differences. 3. Staphylococcus aureus-The mean log of 16 units of finished product breaded shrimp collected prior to freezing is greater than 2.00 (i.e., geometric mean greater than 100/g) and exceeds the mean log of 16 units of stock shrimp by more than twice the standard error of their difference (2 SED). CPG 7108.25. Effective August 1, 1983. Title: Fish-Fresh and Frozen, as Listed-Adulteration by Parasites Action Level: For tullibees, ciscoes, inconnus, chubs, and whitefish: 50 cysts per 100 pounds (lbs.) provided that 20% of the fish examined are infested. For bluefish and other freshwater herring: fish averaging 1 lb or less, 60 cysts per 100 fish, provided that 20% of the fish examined are infested. For fish averaging over 1 lb, 60 cysts per 100 lbs of fish, provided that 20% of the fish examined are infested. For rosefish (redfish and ocean perch), 3% of the fillets examined contain one or more Copepoda accompanied by pus pockets. CPG 7108.06. Effective October 1, 1980 Natural Toxins Title: Clams, Mussels, Oysters, Fresh or Canned-Paralytic Shellfish Poison (PSP) Action Level: PSP at 80 micrograms (µg) per 100 g of meat. CPG 7108.20. Effective October 1, 1980 Title: Decomposition and Histamine in Canned Albacore, Skipjack, and Yellowfin Tuna Action Level: Histamine content at 50 milligrams (mg) per 100 g of meat. CPG 7108.25. Effective July 1, 1981   SOURCE: FDA (1985).

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Seafood Safety TABLE 8-2 FDA Action Levels for Chemical Contaminants Substance Action Level (ppm) Type of Food Methylmercury 1.0 Fish, shellfish, crustaceans, and other aquatics PCBs 2.0 Fish and shellfish Aldrin 0.3 Fish and shellfish Chlordane 0.3 Fish Dieldrin 0.3 Fish and shellfish DDT, DDE, and TDEa 5.0 Fish Endrin 0.3 Fish and shellfish Heptachlor and heptachlor epoxide 0.3 Fish and shellfish Kepone 0.3 Fish and shellfish   0.4 Crabmeat Mirex 0.1 Fish Toxaphene 5.0 Fish a DDT = dichlorodiphenyltrichloroethane; DDE = dichlorodiphenyldichloroethane; TDE (DDD) = diphenylethanedichlorophenylethane. SOURCE: FDA (1987). important point. Standards are not an essential prerequisite to Agency action. We regularly use an internal health hazard evaluation process to determine whether a contaminant in a particular sample would be likely to render that food injurious to public health (Benson, 1990). Indeed, it is by way of these broad-based responsibilities to control deleterious substances in food that the agency controls microbiological pathogens in seafood. In certain instances the mere measurable presence of a pathogen will signify an adulterated product. The agency treats Shigella dysenteriae, Vibrio cholerae O-1, Salmonella, and Listeria , among others, in this fashion. The effective regulatory limit for these pathogens is equivalent to the ability of the measurement methodology to detect them. For others, the mere measurable presence of a pathogen does not constitute an automatic hazard, but significant populations would. For this class of pathogens the agency has developed a reactive strategy that allows for a broad-ranging and flexible approach to determine adulteration. Indeed, a majority of FDA enforcement actions for microbial pathogens are determined on the basis of this less formal, flexible response (John Kvenberg, FDA, personal communication, 1990). However, this flexible system is presently under review by the National Advisory Committee on Microbiological Criteria for Food (NACMCF). The NACMCF was established and jointly funded by the Departments of Defense, Agriculture, Commerce, and Health and Human Services to provide advice on the further development of microbiological action levels in food. The committee recently proposed new criteria for cooked, ready-to-eat shrimp and cooked, ready-to-eat crabmeat. In general, the present system for setting regulatory limits could be both

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Seafood Safety adequate and appropriate if such guidelines were effectively implemented. However, several critical points must be raised. First, there are areas in which guidelines are either inappropriate or nonexistent. For example, as noted in the section of this report addressing the question of chemical contaminants in seafood, the appropriateness of the present 2.0-ppm tolerance for PCBs, and the lack of specific regulatory limits for certain other chemical contaminants such as polycyclic aromatic hydrocarbons (PAHs), cadmium, lead, and dioxin, are questionable. Further, as noted elsewhere in this report, there remains a persistent concern about certain natural toxins for which the FDA has yet to determine a discernible regulatory strategy. Specifically, the committee suggests that the agency more fundamentally address the question of regulatory guidelines for domoic acid and ciguatera. Product concepts are emerging, both in processing and in retail settings, that may pose safety questions as yet unaddressed by specific FDA guidelines (e.g., sous vide, modified atmosphere packaging, custom smoking techniques, and further processing in the retail setting). Finally, it should be noted that FDA has not communicated these regulatory limits effectively to intended parties. The regulatory limits thus far determined by the agency are communicated by way of FDA Compliance Policy Guides (FDA, 1985), notices in the Federal Register, and even in various FDA memoranda. It can be difficult to locate these regulations because FDA publishes in such a wide variety of sources. A more concerted effort to publish in a generally available, single-source, regularly updated volume would provide for more effective communication of these limits. National Shellfish Sanitation Program One of the primary seafood safety responsibilities of the FDA is its role as federal representative on the Interstate Shellfish Sanitation Conference (ISSC)–the organization that implements the National Shellfish Sanitation Program. The NSSP is a cooperative program in which FDA, state agencies, and private industry work to control the quality and safety of oysters, clams, and mussels sold in interstate commerce (FDA, 1989a,b). Within this program the agency is required to (1) set certain product guidelines and standards, (2) evaluate state compliance with those rules, and (3) certify continued state participation in the ISSC. The principal objective of the NSSP is to "provide a mechanism for certifying that shellfish shipped in interstate commerce meet agreed upon, specific sanitation and quality criteria" (FDA, 1989b). The sanitary quality of shellfish is based on both growing water and wholesale market strategies. The most significant contribution of the program has been the creation of classification and monitoring strategies designed to ensure that shellfish are taken from harvesting waters significantly free of microbial contaminants. For a state to continue as a certified member of the program, it is required to survey all growing waters within its jurisdiction and classify those waters as to their acceptability for harvesting shellfish. Waters that have not been surveyed and classified must be closed. The microbiological requirements in this program are discussed in Chapter 3. The state must then test the sample within 24 hours of the shipment entering the state. If two successive samples from the same shipper are found to be in violation of both GMPs and microbiological criteria, "the shellfish regulatory authority at the source should be requested to supply information to the receiving jurisdiction concerning the

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Seafood Safety source of the product and the shipper's status may be subject to rejection by the receiving state shellfish regulatory authority. Acceptance of future shipments should depend upon satisfactory reports by shellfish regulatory authorities at the point of origin" (FDA, 1989b). These regulations have been the focus of some controversy. The move away from the independent use of microbiological criteria is viewed by some with concern. Others remain convinced that the use of fecal coliform as a broad-based indicator organism is inappropriate. Additionally, there remains a measure of concern because the NSSP is a voluntary program in which both the shipper and the receiver retain a significant amount of discretion in using the safety and quality information generated by program participation. One contribution of the NSSP has been the characterization of a list of alert levels for several trace metal contaminants. These are listed in Table 8-3 (Ratcliffe and Wilt, 1971). TABLE 8-3 NSSP Alert Levels for Trace Metals (ppm wet weight) Metal Oysters Hard-Shell Clams Soft-Shell Clams Cadmium 3.5 0.5 0.5 Lead 2.0 4.0 5.0 Chromium 2.0 1.0 5.0 Zinc 2,000.0 65.0 30.0 Copper 175.0 10.0 25.0   SOURCE: Ratcliffe and Wilt (1971). It is worth noting that these alert levels for metals were not formulated on the basis of toxicity assessment, but rather are based on a 20-year-old survey of average concentrations of metals in U.S. coastal waters (Isaac and Delany, 1975). The alert levels do not constitute a formal regulatory limit and require further, more rigorous analysis. Indeed, these levels were never formally accepted by the NSSP, but are being used by certain states to control trace-metal levels in shellfish (Robert Wetherell, FDA, personal communication, 1990). Inspection and Enforcement The setting of limits by an agency, however, is only an initial step in regulating contaminants in seafood. The agency must then determine the current levels in seafoods and the proportion of seafood products that exceeds the regulatory limit. To characterize the success of federal efforts in reasonably protecting the U.S. seafood consumer, the degree to which such regulations are being implemented by way of monitoring, inspection, and enforcement must also be characterized. At the federal level, several programmatic efforts are currently in place to inspect and survey seafood for public health-related contaminants.

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Seafood Safety U.S. Environmental Protection Agency Because seafood is most typically harvested from the natural environment, considerations of monitoring in support of seafood safety should necessarily include EPA programs to monitor general water quality. The agency carries out several programs as part of its responsibilities under the Federal Water Pollution Control Act (hereafter referred to as the Clean Water Act) (CWA: 33 U.S.C. 1,251 et seq.) and the Marine Protection, Research and Sanctuaries Act (MPRSA: 33 U.S.C. 1,401 et seq.). Under the CWA, the agency is mandated to regulate all discharges into navigable waters of the United States (Sec. 520), including the territorial sea [Sec. 106(a)]. The MPRSA regulates the transportation and dumping of waste into federal waters seaward of the territorial sea (and dredged material within the territorial sea) (Sec. 502). The EPA has the authority, particularly under the CWA, to regulate a broad suite of environmental contaminants. Under Section 304(a)(4) the CWA identifies a list of "conventional pollutants," including oil and fecal coliform bacteria. The chemical toxins examined in the present study are addressed in Section 307(a)(1). The agency currently lists and regulates a total of 126 "priority pollutants" (40 CFR 122, App. D), which include both organic chemicals and metals. The identification of critical contaminants characterizes the initial effort of EPA both to monitor environmental quality in coastal areas and to assess the toxicity of chemical contaminants in seafood. The importance of these strategies resides in the fact that a critical control point for ensuring the safety of the U.S. seafood product is the quality of the environment in which the fish are harvested. For the most part, subsequent safety assurance strategies (apart from cooking) are designed to ensure that contaminant levels are not further elevated. Therefore, any effective control strategy should begin with efforts to reduce the probability that contaminated seafood enters the processing and retail system. Further, by focusing on the quality of harvesting environments, one fundamentally achieves an opportunity to restrict products at the point of least added value. However, current environmental monitoring programs do not focus directly on the question of seafood safety. Rather, they are designed to assess the general health of our marine and aquatic environments. Efforts to use such data directly for consideration of seafood safety suffer because most of the available environmental data (1) do not focus on seafood harvesting areas, (2) lack a common methodological approach, and (3) do not focus on the edible portion of seafood in order to determine public health hazards, as opposed to environmental health aspects. This last point is raised because most evaluations of contaminants in fish are done not on edible tissue but rather on the whole fish or on specific internal organs. U.S. Food and Drug Administration The Food and Drug Administration serves as the agency with primary authority for seafood product inspection. Seafood inspection within the FDA falls generally into four major categories: (1) general plant and product inspection, (2) import control inspection, (3) routine and periodic surveys for residual chemicals, and (4) compliance inspection for the National Shellfish Sanitation Program.

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Seafood Safety Any evaluation of such a monitoring and inspection program should address three related questions. First, are the inspections carried out with sufficient frequency to ensure compliance with regulatory guidelines? Second, is the sampling plan used by the program sufficient to develop a reliable estimate of the results? Third, is the program sufficiently broad to ensure that the regulatory guidelines provide a sufficient measure of protection to the public? This third point is a rather important one: that is, are contaminants being found in seafood for which the agency has not developed a sufficient regulatory response and for which there is evidence of public health concern? An effort is made here to address each of these questions in the characterization of federal monitoring, inspection, and enforcement programs. As part of its general responsibilities under the FFDCA, FDA carries out a general inspection program involving periodic visits of its inspectors to processing facilities that prepare products destined for interstate commerce. The frequency and type of inspection are determined by the nature of plant operation, the volume of product produced, the record of previous compliance with regulations, the existence of consumer complaints, or other evidence of a problem (ICF, 1986). These inspections involve the entire suite of issues for which FDA has statutory authority. That is, they address overall plant sanitation and economic fraud (among other things), in addition to issues relating directly to seafood safety. Given the mandate of this study, the committee's effort is directed solely at programs developed to mitigate problems related to seafood safety. Inspections directed at domestic products and processing are oriented primarily toward the maintenance of plant sanitation by way of enforcing good manufacturing practices. Although there is an acknowledged relationship between compliance with GMPs and seafood safety, the most direct impact of these inspections is on product quality. During the past several years, sanitation inspection has constituted a majority of the FDA's inspection effort. However, product evaluations for potential seafood contaminants also play a role. Data characterizing the agency's efforts to inspect for biological and chemical contaminants in both domestic and import programs are contained in Table 8-4. In this program, biological hazards are limited almost exclusively to microbiological contaminants and parasites. Paralytic shellfish poison (PSP) and other natural toxins are more fundamentally monitored in other programs (i.e., the NSSP or state programs). Table 8-4 highlights two obvious issues: (1) that there has been a slight increase in the number of products evaluated in recent years, and (2) that most of the program effort is directed at imported products. The results of these evaluations are contained in Table 8-5. It should be noted here that individual states also carry out additional plant inspections that provide a substantial complementary contribution to this federal inspection effort. Those data taken alone suggest that a significant proportion of both domestic and imported products are in violation of FDA regulations. However, they are derived from samples of a small proportion of seafoods that were selected as potentially troublesome lots because of previous experience or other information. It is questionable and probably unlikely that random sampling would yield such high violation rates. However, the precise relationship between directed and random inspections cannot be effectively calculated and therefore a general violation rate cannot be known.

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Seafood Safety Table C STATE REGULATORY PROGRAMS RELATIVE TO SEAFOOD PRODUCT SAFETY AND QUALITY

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Seafood Safety Table A Review of State Regulatory and Industry Responses (March 6, 1990) Concerning Seafood Quality and Safety TEXAS Industry Character (1990) 1. In 1988, dockside seafood landings in Texas ranked 14th in production (96.0 million pounds) and 5th in value ($175.7 million). 2. Primarily warmwater, nearshore fisheries from subtropical sources were supplemented with significant imports including foreign entries via ground transport from Mexico. 3. Fish vessel ownership split between individuals and company-based operations. 4. The high value for Texas seafood production is attributed to the shrimp harvest, which generates approximately 80% of the landed value. Blue crab and oyster production constitutes the next major portion of the industry, whereas finfish production is meager due to management decisions for recreational interest. 5. Most significant segment of seafood processing involves blue crabs and oysters; larger shrimp harvest supports a traditional off-loading/packing practice destined for fresh and frozen markets or further processing outside Texas. 6. Consumption includes significant portion of ethnic groups and some particular tastes (e.g., Texas consumes 40% of nation's cultured catfish production). 7. Aquaculture is in a fledgling yet developing state, with primary focus on catfish and growing interest in tilapia and crawfish. Saltwater aquaculture is not evident to date. 8. Major recreational finfish fisheries exist for near and inshore species. 9. There are strong regulatory distinction and enforcement between recreational and commercial fishing activity. 10. Imports continue to increase to suit regional demands. Primary Product Safety Problems 1. Raw molluscan shellfish consumption constitutes most important concern for regulatory scrutiny among Texas-based seafood production and use, but it is not considered a major problem without effective controls. 2. Stronger enforcement penalties have proved effective and necessary to curb illegal harvest or bootleg activity from unapproved growing areas. 3. There is a growing concern about use of further processing in retail settings.

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Seafood Safety Primary Product Quality Problems 1. Assuring postharvest product quality and maintaining product quality in wholesale and retail settings (e.g., basic time temperature abuse). 2. Recurrent problems include initial spoilage, excessive or undeclared use of sulfites, and misuse of phosphates and net control labeling. Additional Problems 1. There is no specific legislated authority to monitor postharvest product quality with the exception of molluscan shellfish. 2. Blue crab processing in Mexico has not evolved to a level of concern for more surveillance of ground imports (via Mexico), yet should activity increase the only regulatory recourse for Texas health authorities is reliance on limited federal screening upon entry. This situation places strong dependence on foreign government assurance that plants comply with adequate GMPs for potential ready-to-eat seafood items. 3. More routine product assessments are warranted to ensure that regional and site-specific aquatic resources do not harbor potential contaminants. Despite interagency cooperation, authorities lack sufficient allocations to support activity under the "Aquatic Life Law" that directs field sampling for routine product analysis of potential chemical contaminants. The respective health authorities rely on data from agency programs more directed to assess the water quality and consequences on aquatic life. 4. Authorities question if illegal harvest restrictions should be imposed to deter catching finfish from areas identified as potentially toxic (e.g., closures, advisories, bans), similar to the authority to halt harvest of shellfish from prohibited waters. Regulatory Concerns for Seafood Industry 1. An ethnic related problem exists for bootleg crabmeat. 2. Principal seafood surveillance programs focus primarily on ensuring seafood safety, with concomitant inference for quality, thus leaving seafood quality assurance an industry responsibility. Regulatory Concerns for Their Respective Programs 1. Based on home rule, counties and cities establish their own surveillance for retail and restaurant operations. They rely on help from their state-level counterparts, which can be directly involved in the absences of local authorities. This system warrants additional attention to ensure more uniform and specific activity across the retail sector, particularly in reference to seafood products and handling. 2. State health authorities do not have the mandate or support to conduct technical work (research) to assess new processing innovations (e.g., alternative crab

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Seafood Safety   washing procedures). Current regulatory programs must rely on developments and verification in industry or academic settings, or from the federal government. 3. Current shellfish program, like all state programs, lacks ability to confidently trace molluscan shellfish back to the source of actual harvest, thus limiting resolution of any adverse consequence beyond the processor. 4. Current surveillance programs for seafood safety need more manpower and funds to support additional and more uniform coverage from dock, through processing, to retail sectors. 5. Although academic and federally based programs offer annual educational support for the agency staff, additional seafood-specific training is necessary particularly at county and city levels. Current programs depend on substantial amounts of on-the-job training. 6. Federal inspection activity in Texas had decreased, leaving a larger burden for state health authorities. 7. Coastal, inshore water quality assessments need to include more work with long-term trend assessments and "bioaccumulation." 8. Initial lack of interagency coordination in legislation and program development for aquaculture has confused regulatory distinction in authority for surveillance of processing cultured products. Industry Concern for Regulations 1. There is some confusion over the respective roles and rules of the divisions within the Texas Department of Health and other agencies relative to permitting and surveillance of traditional seafood processing. 2. To avoid federal inspection, some seafood processors can cease operation, yet maintain their license to process, then resume processing once the probability of inspection is lower. 3. Licensing and permitting requirements with Texas Departments of Health, Agriculture, Parks and Wildlife, and Texas Water Commission can be confusing and discouraging for aquaculture development. Recommendations 1. Additional emphasis and support should be directed to increase and standardize seafood quality and safety surveillance in the retail and restaurant sectors as monitored by respective county and city authorities. 2. Aquaculture development, particularly in processing sector, warrants more interagency coordination relative to pertinent product quality and safety assurances. 3. Regulatory seafood inspectors for processing through retail need additional and more uniform training in seafood processing and handling. 4. A condensed compilation of all related Texas regulations on seafood quality and seafood safety should be published for industry reference. 5. Health authorities and seafood processors should consider a "certification" program based on minimal, standardized training for inspectors, processing

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Seafood Safety   personnel, and plant managers. 6. Additional manpower is needed for adequate surveillance of seafood processors and wholesalers. Regulatory Initiatives None identified. Industry Initiatives None identified. Summary Texas seafood production and processing do not pose any major acute seafood safety concerns that are not being addressed by current regulatory programs. The processing sector is primarily limited to two species, blue crabs and oysters. Product quality compromised prior to processing or in wholesale retail/restaurant settings is the principal concern. Regulatory efforts at county and city level may warrant reassessment for the surveillance for seafoods in retail. The evolving aquaculture industry offers an opportunity for agencies to evaluate their roles and initiate interagency cooperation to better address cultured product quality and safety. Continuing concern for potential contaminants in edible, aquatic resources destined for commercial or recreational harvest will require sufficient funds to support established health programs and encourage additional interagency cooperation.

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Seafood Safety Table B STATE REGULATORY JURISDICTIONS RELATIVE TO SEAFOOD PRODUCT SAFETY AND QUALITY

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Seafood Safety Table C STATE REGULATORY PROGRAMS RELATIVE TO SEAFOOD PRODUCT SAFETY AND QUALITY

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Seafood Safety Table A Review of State Regulatory and Industry Responses (May 24, 1989) Concerning Seafood Quality and Safety WASHINGTON Industry Character (1989) 1. Ranked 9th in production and 6th in landed value. 2. Primarily coldwater source production and pass-through processing for Alaska and offshore vessels. 3. Principal species – salmon, halibut, albacore, tanner and dungeness crab, shrimp, and oysters. 4. Introduction of large-scale offshore processing. 5. Significant portion of seafood utilization in King County. 6. Aquaculture principal species – salmon and oysters. 7. Recreational fisheries increasing. 8. Imports constitute significant and increasing portion of commerce. Primary Product Safety Problems 1. Molluscan shellfish safety – microbial consequences and PSP on the product and in the environment as encountered by both commercial and recreational interests. 2. Monitoring for toxic contaminants in the environment with need to increase surveillance and interprogram coordination for prevention and assessments. Regulatory Concerns 1. Use of live tanks (wet storage) and mixed molluscan species should be addressed. 2. Need to improve epidemiology including commercial and recreational consequence. 3. Need more equitable surveillance for imports versus domestic products, and products during and from offshore processing. 4. Currently programs have experienced some poor coordination in identifying import problems, general food safety/quality concerns and species marketing and introduction. 5. There are occasional conflicts with federal program as pertains to concomitant state responsibility (e.g., state versus FDA versus NMFS on foreign certification for wholesomeness). 8. Public perception versus reality (education) for seafood safety. 9. Lack of adequate funding, staff and analytical tools, with emphasis on rapid methods.

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Seafood Safety Regulatory Initiatives 1. Statewide recreational mollusc harvest regulation. 2. Expand labeling to inform public. 3. Initiate education programs for regulatory agencies, industry, and public. Industry Initiatives 1. Canned Salmon Control Plan. 2. Annual training/education in cooperation with academic based expertise (e.g., Sea Grant Programs). Recommendations 1. Formalize and exercise HACCP concept in regulatory and commercial practice. 2. Improve current regulations and analytical capability. 3. Address microbiological standards for high-risk products (e.g., raw, cooked ready to eat). 4. Address safety issues for molluscan shellfish in retail (e.g., use of live tanks, tagging, and pull dates). 5. Expand education of • public (high-risk groups and special issues); • industry (consider "certification"); and • regulators (more and more frequent seafood training). Summary Washington State is not a problem area due primarily to unique features of environment, specific species involved, nature of processing (largely pass-through operations), and effective, responsible regulatory programs. Where problems exist they have been identified and are being addressed with current capability and recommendations. The primary seafood safety concerns are molluscan shellfish consumption and specific environmental contaminants. Washington State stands as an excellent example that regulation (inspection, surveillance) does exist and does work at the state level.

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Seafood Safety Table B STATE REGULATORY JURISDICTIONS RELATIVE TO SEAFOOD PRODUCT SAFETY AND QUALITY

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Seafood Safety Table C STATE REGULATORY PROGRAMS RELATIVE TO SEAFOOD PRODUCT SAFETY AND QUALITY