Seafood Safety (1991) / Chapter Skim
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8. Seafood Surveillance and Control Programs
8. Seafood Surveillance and Control Programs
Pages 286-414
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From page 286... ...
. The FDA selves as the lead agency in setting and enforcing regulatory limits for seafood products.
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From page 287... ...
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.
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From page 288... ...
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.
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From page 289... ...
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.
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From page 290... ...
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.
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From page 291... ...
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)
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From page 292... ...
. 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.
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From page 293... ...
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.
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From page 294... ...
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.
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From page 295... ...
U.S. Food and Drug Administration The Food and Drug Administration serves as the agency with primary authority for seafood product inspection.
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From page 296... ...
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.
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From page 297... ...
. TABLE 8-5 General FDA Seafood Inspection Program Results, 1989 Inspection Biological Hazards Chemical Contaminants Domestic samples analyzed 1,109 541 Adverse 231 (21%)
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From page 298... ...
As shown in Table 8-4, a majority of the FDA inspection effort is, in fact, directed at imported products, partly because imports constitute a majority of the seafood products consumed in the United States. However, the predominance of imports in inspection is more fundamentally a result of FDA policy to direct resources toward areas suspected of safety problems.
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From page 299... ...
These data have led FDA to assert that its current regulatory effort to control exposure to chemical contaminants is sufficient. The agency argues that the current set of action levels, designed to guide the general inspection program, reflect current concerns over residual contaminants.
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From page 300... ...
These product specifications are designed primarily to ensure product quality, as opposed to product safety, but do address safety issues to the degree to which they consider FDA seafood safety policies and to which assurances of product quality also provide a means to increase product safety. The inspection service carries out a wide range of inspection activities including vessel and plant sanitation inspection and seafood product evaluation (which includes a limited number of laboratory evaluations, typically fewer than 100 per year, for biological and chemical contaminants)
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From page 301... ...
It should be reiterated that this voluntary program is not directed primarily at seafood safety. Rather, the program is directed almost exclusively at plant sanitation and product quality and condition.
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From page 302... ...
As with epidemics of other communicable diseases, prompt telephone or electronic notification of food-borne disease outbreaks involving commercially available food products or potential interstate consumption is important for control purposes. However, the quality and completeness of routine surveillance data collected by local or county public health officials and forwarded to state or territorial health departments for transmission to CDC are not uniform and are inadequate for planning and evaluating food safety programs.
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From page 303... ...
who suggested that "food-borne outbreaks in Florida are reported if the etiological agent is on the list of reportable diseases." For those cases in which the disease was mild or had nonspecific symptoms, no specific diagnostic test was available, or a specific food vehicle was not readily apparent, especially when occurrence was mainly restricted to single cases or to small clusters, reporting tended to be very poor. All state health departments that were questioned reported that local, county, or state personnel attempted to identify and trace implicated food vehicles but acknowledged that the success rate was low.
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From page 304... ...
In this section, the committee considers that suite of programs not focused exclusively within the federal environment. The information used to develop this characterization was compiled by way of discussions from group meetings and individual interviews with a variety of coastal state regulatory agencies and respective industries in an effort to better assess the "typical" state role in assuring seafood safety (see appendix to this chapter)
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From page 305... ...
Microbial Contaminants State efforts in environmental monitoring to protect public health from microbial contaminants are primarily carried out under the auspices of the NSSP and addressed elsewhere in this chapter. Although molluscan shellfish-borne illnesses remain the dominant, immediate regulatory concern for most states, many felt their molluscan shellfish monitoring programs were adequate and appreciated the guidance provided by NSSP.
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From page 306... ...
Epidemiology and pertinent state interviews confirm that current state regulatory programs are adequately protecting public health from toxins associated with red tide. Recreational harvesting carried out by individuals unaware of PSP risks is the major reason for continued warnings.
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From page 307... ...
This commercial activity receives the least amount of regulatory surveillance relative to product safety. States justify their regulatory posture with the assertion that little evidence exists to support, with the exception of molluscan shellfish, direct regulatory action for seafood product safety on commercial vessels.
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From page 308... ...
. State regulatory agencies realize that steps to initiate more vessel seafood safety surveillance would be quite complicated and time-consuming due to the diversity of vessel types, variable harvest schedules, numerous dockside landings, and multiple products.
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From page 309... ...
Organization of state regulatory authority for seafood safety during processing is less uniform among states than that for harvesting, distribution, and marketing. State health departments are most often responsible for product safety in seafood processing.
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From page 310... ...
Combined with the commitment to monitor shellfish growing waters' state regulatory attention to ensure safe, raw molluscan shellfish often represents the most extensive regulatory effort per single seafood commodity. Continuing raw molluscan-related illnesses justify this commitment, along with the realization that monitoring for harvestable waters represents a stalwart effort to prevent coastal pollution in producer states.
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From page 311... ...
. Additional State Considerations Meetings and interviews with state groups revealed a number of common concerns that warrant additional consideration in evaluating state regulatory roles in ensuring seafood safety.
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From page 312... ...
Admittedly, federal and state regulatory attention for safety in aquacultured products lags behind culture development, but there has been little research to characterize food safety problems with such products. Concerns for chemical and microbial contaminants in the culture water, and the use of therapeutic drugs, which are being addressed by FDA efforts, should be expanded to include more state involvement.
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From page 313... ...
Imports Regulatory scrutiny for product safety of imported seafoods is the primary and initial responsibility of the FDA, but eventual domestic distribution can evoke additional state responsibility. Concerns for foreign product identification, country of origin declarations, certified sources, adulteration, and other seafood safety-related attributes become a state regulatory responsibility after the imports enter state commerce.
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From page 314... ...
concept for product quality and safety. Despite these prior and ongoing efforts, most seafood industry representatives were not familiar with HACCP in a seafood processing or retail setting, yet their daily practice intuitively employs the critical point assessments without necessarily recording the daily events.
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From page 315... ...
Officials from coastal states in the Northeast including Massachusetts, New York, and Connecticut indicated that the seafood of major concern was raw molluscan shellfish and the causal agents were viruses. This reflects concerns over both domestically produced and imported molluscs, mostly clams, and the prevalence of local consumption of uncooked or very lightly cooked shellfish.
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From page 316... ...
The island states and territories Hawaii, Puerto Rico, Virgin Islands, and Guam show disease patterns that are a consequence of both the major local fish supply and local eating customs. In all areas, seafood constitutes a major part of the diet and is the cause of significant food-borne disease dominated by cicuatera and to a lesser extent, scombroid fish poisoning.
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From page 317... ...
The state is an importation point for fish from the Caribbean area, including potentially scombrotoxic fish, and is also subject to periodic red tides due to Gymnodinium breve that make local shellfish toxic. However, the major seafood-related health concern is vibrio disease related to raw shellfish consumption.
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From page 319... ...
STATE-FEDERAL REGULATORY LIAISON Because seafood diversity poses region-specific concerns in monitoring coastal waters, in addressing species unique to local harvests and process settings, and in accessing point-of-sale transactions and recreational fishing, state regulations have played the more immediate and dominant role in surveillance of seafood safety and quality. However, federal cooperation and support is essential.
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From page 320... ...
The Interstate Shellfish Sanitation Conference represents the most comprehensive, routine state-federal liaison specifically established to address seafood safety concerns. This national organization ensures cooperation among state authorities, NSSP, and respective molluscan industries in sharing the responsibility to establish federal and state regulations for molluscan shellfish product safety.
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From page 321... ...
Basically, the plan provides routine, uniform surveillance for particular product quality concerns, in addition to the paramount processing requirements to prevent botulism. This program is a voluntary cooperative agreement among participating packers of canned salmon, the National Food Processors Association (NFPA)
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From page 322... ...
in Tallahassee, Florida introduced a seafood Product Quality Code program. The premise of the code was to improve seafood product quality and safety through buyer education.
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From page 323... ...
Some supermarket advertising has adopted these same approaches to promote consumer confidence; use of the DOC voluntary inspection is a common boast. Industry initiatives and concomitant government-based promotional efforts to encourage seafood product quality and safety are all well intended and can be helpful, but they must remain aware of possible legal requirements and risks.
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From page 324... ...
Risks beyond establishing standards involve fewer legal concerns. Again, although helpful in intent, seafood product quality and safety declarations can result in confusion and false warnings.
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From page 325... ...
seafood industry is the standards and inspection practices developed by the Canadian government (DFO, 1988~. The Canadian seafood inspection program is based on an HACCP-type TABLE approach, and includes quality- and safety-oriented plant inspection, vessel and landing site inspection, and compliance with a broad list of contaminant action levels (which include the regulation of all agricultural chemicals and their derivatives)
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From page 326... ...
The decision to develop a multifaceted seafood safety program that includes programmatic efforts from harvesting through wholesale distribution was based on several assumptions about seafood commerce. First, a program limited to product sampling plans "has limitations and cannot by itself perform adequately to deliver the levels of assurance demanded by the public and buyers at a reasonable cost." Second, limiting a program to product or plant inspection detects problems only after value has been added to the product.
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From page 327... ...
The cost of the entire DFO inspection was approximately Canadian $35 million in 1988 which, distributed across the amount of total seafood production, provides an estimated cost per pound of approximately $0.01 (David Bevan, Canadian Department of Fisheries and Oceans, personal communication, 1989~. TABLE 8-9 Frequency Totals for Various Inspection Classes in Canada Total site inspections Total field product inspections Total laboratory product inspections Total inspections for export certification 3795~ 939Q00 409 18,900 SOURCE: Bevan (1989)
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From page 328... ...
COMPARATIVE RISKS FOR CONSUMERS OF VARIOUS SEAFOOD PRODUCTS A clearer view of the actual risks faced by seafood consumers can be obtained by looking at the fish and seafood products most widely and frequently consumed by Americans. Consumption and supply data (USDA, 1985a,b; NMFS, 1989, 1990)
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From page 329... ...
This is controlled by analysis and rejection of such fish by both processors and regulators. Canned tuna must fall below the FDA action levels.
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From page 330... ...
Clearly, the highest-risk category of seafood products for the general U.S. consumer is molluscan shellfish eaten raw.
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From page 331... ...
It should be apparent from the preceding discussion that people at greatest risk of seafood-borne illness are (1) consumers of raw molluscan shellfish, (2)
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From page 332... ...
Residual Chemical Contaminants An assertion that current federal regulatory guidelines are sufficient to protect consumers from residual chemical risks is rather more difficult to support. At present, FDA enforcement activities focus primarily on those 15 residual chemical contaminants for which the FDA has developed action levels.
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From page 333... ...
Monitoring and Inspection In general, the present monitoring and inspection program carried out by all federal agencies lacks both the frequency and the direction sufficient to ensure effective implementation of the nation's regulatory limits for seafood safety. However, the need for a renewed and redesigned seafood inspection effort is now almost universally acknowledged.
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From page 334... ...
population. Regulation of Imported Products One of the important differences between the regulation of domestic and imported seafood products is that, for the most part, any assurance of the quality of foreign harvesting environments and postharvest handling practices is lacking.
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From page 335... ...
However, given the proportion of imported seafood products, the committee suggests that the question of imported product regulation is in need of fundamental reconsideration. The large portion of the U.S.
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From page 336... ...
Unlike most other food commodities with more uniform production and product forms, seafoods require more regional or local control and surveillance. In general, the committee's evaluation of existing state regulatory programs for seafood safety suggests that states have developed, with some notable exceptions, a sufficient authority to respond reasonably to problems related to seafood safety.
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From page 337... ...
1989. Trends in the importation of selected fresh and frozen seafood products into the southeastern United States.
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From page 338... ...
Liston, eds. Seafood Quality Determination.
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From page 339... ...
1985. The debate over fish product quality and inspection.
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From page 340... ...
1990b. Industry and Regulatory Interface to Address Concerns for Seafood Product Quality and Safety.
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From page 341... ...
1989. Microbiology of aquacultured products.
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From page 342... ...
The SEA project was separate from, yet similar to, the work conducted by the committee. The basic approach for each group meeting was to assemble industry and respective state regulatory representatives to discuss the current state regulatory structure and practices in addressing seafood safety in production, processing, and marketing.
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From page 343... ...
Any potential problem areas are being addressed by current regulatory programs (i.e., molluscan shellfish harvest)
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From page 344... ...
1. In all levels of seafood industry there is some general confusion coupled with a lack of awareness of the current, pertinent seafood qualifier and safety regulations and regulatory authorities.
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From page 345... ...
3. Consider a structured, periodic training program on seafood safety and regulations for all segments of the industry and regulatory agencies.
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From page 346... ...
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From page 348... ...
Primary Product Safety Problems 1. Raw molluscan shellfish consumption is a principal seafood safety concern relative to environmental contaminants.
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From page 349... ...
7. Agencies need to improve their data clearing and storage methods relative to seafood epidemiology, water quality, and seafood product safety assessments in order to better prioritize programs and to assess effectiveness of the programs.
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From page 350... ...
Summary Regulatory structure and activity in California represents one of the nation's most responsive and current state-based programs to assure seafood product safety. Where problems occur they are being addressed or have been mandated for attention.
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From page 353... ...
Primary Product Safetv Problems 1. Raw molluscan shellfish harvest, processing and consumption versus water quality "indicator" regulations relative to potential pathogens (e.g., Vbno vulnif cus)
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From page 354... ...
Industry Concern for Regulations 1. Overlapping and sometimes inconsistent regulations pertinent to product quality and sanitation.
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From page 355... ...
7. Ensuring product quality and safety for recreational harvest sold, legally or illegally, directly to wholesalers or to food service establishments (e.g., potential ciguatoxic fish)
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From page 356... ...
Summary SEAFOOD SAFETY Florida is more prone to seafood product safety problems due to its geographic setting and particular products. The industry is very diverse in product forms and levels of processing, ranging from one-man harvest-sell operations to the world's largest processing firms for shrimp and scallops.
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From page 359... ...
2. In ranking problems relative to the amount of regulatory attention, raw molluscan shellfish harvest, shellfish processing and consumption, and blue crab processing are the primary concerns.
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From page 360... ...
Aquaculture products not yet an issue, but should evolve in compliance with Department of Agriculture regulations for product quality and safety, and with reference to species and water quality concerns of Department of Natural Resources. Regulatory Concerns for Seafood Industry 1.
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From page 361... ...
Currently planning more in-service training in seafood quality and safety for regulatory agencies and industry as provided through Georgia Sea Grant Program and Marine Extension Service.
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From page 362... ...
The current state regulatory scheme is well organized, with one dominant department adequately addressing most seafood safety concerns. Requests for more specific training and orientation have been noted both for the industry and for regulatory agencies.
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From page 365... ...
8. Imports of traditional Hawaiian seafood products (such as mahimahi)
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From page 366... ...
Issues In the Regulation of Seafood Safety Industry Initiatives 1. At present, there is little formal regulatory response, beyond public education, to recreationally caught fish.
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From page 367... ...
Regulatory agencies are generally knowledgeable and well trained to deal with the state's significant seafood safety issues. However, there are important gaps in the state's jurisdiction.
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From page 368... ...
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From page 369... ...
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From page 370... ...
Primary Product Safety Problems 1. Primary seafood product safety problems in Louisiana involved the necessary regulatory attention and industry compliance concerns for production and consumption of unprocessed, raw molluscs.
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From page 371... ...
2. The Louisiana Department of Health and Hospitals has the authority under the State Food, Drug and Cosmetic Law to inspect any vessel or vehicle carrying a commercial food product, but there are no routine vessel inspections with the exception of some molluscan shellfish harvest.
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From page 372... ...
4. Seafood product quality and safety liabilities must be adjusted to include more responsibility setting.
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From page 373... ...
Summary Louisiana represents a state with very abundant and valuable seafood production, which is essential to suit the traditional demands of consumers and utility of in-state and neighboring state processors. This production includes species of primary product safety concern (i.e., molluscan shellfish and certain fish species)
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From page 376... ...
. Primary Product Safety Problems 1.
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From page 377... ...
Summary The Commonwealth of Massachusetts produces and imports a wide variety of fresh, fresh-frozen, and processed seafood products. Recreational harvesting for both fish and shellfish is common.
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From page 378... ...
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From page 380... ...
Primary Product Safety Problems 1. Attending representative felt that Mississippi agencies and experienced firms believe that state seafood production and processing pose no significant food safety problems, with exception of customary concerns for raw molluscan shellfish.
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From page 381... ...
Regulatory Concerns for Their Respective Programs 1. Identified needs for additional regulatory/inspection personnel and funds are difficult to achieve in light of limited product safety and quality problems.
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From page 382... ...
. Despite some transitional confusion in state regulatory authority, attending industry and regulatory personnel believe there are no major seafood safety or problems in Mississippi that are not or cannot be resolved by the current regulatory scheme.
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From page 383... ...
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From page 384... ...
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From page 385... ...
Primary Product Quality Problems 1. The most common yet easily resolved seafood product quality problem is temperature abuse.
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From page 386... ...
6. Regulation for product quality and safety in interstate commerce can be complicated by lack of uniformity across states for particular seafoods (e.g., boiled versus steamed crabmeat, raw oysters, calico and bay scallops, general grade enforcements)
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From page 387... ...
o. Various state regulatory programs and industry associations should increase participation in professional organizations established to foster more interstate liaison (i.e., AFDO and AFDOSS)
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From page 388... ...
Imports, out-of-state production, and some aquaculture represent the future supplies to meet North Carolina's growing product demands. North Carolina's seafood production and processing have not and are not predicted to pose any significant seafood safety problems that cannot be addressed by existing regulatory authorities and industry cooperation.
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From page 389... ...
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From page 390... ...
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From page 391... ...
1. Local seafood production in Puerto Rico is modest and primarily artisanal.
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From page 392... ...
and retail/restaurant handling represent the primary areas of seafood product safety concern for local authorities. There is little seafood processing, with the exception of tuna canning operations that pose no significant seafood safety problems.
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From page 393... ...
of Puerto Rico was established in 1979 basically as a commercial development program to assist fisheries and aquaculture. Legislated structure aligned programs with the Department of Natural Resources and issued authority ranging from assessing (records access)
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From page 394... ...
The major portion of seafood products consumed in Puerto Rico is shipped from the United States and not subject to routine "import" surveillance by FDA authorities based in Puerto Rico. Although there are no major documented safety concerns associated with these products, product quality has been questioned.
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From page 395... ...
3. Aquacultural development, particularly in the event of molluscan shellfish aquaculture, should be made more mindful of water quality in terms of site selection and various operating parameters that may adversely contribute to product quality and safety.
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From page 396... ...
This arrangement is intended to direct more attention to seafood safety concerns in import surveillance and further assistance for local authorities, principally the Puerto Rico Department of Health, in addressing seafood safety of molluscan shellfish, reshipped products, and any specific issues through various levels of commerce.
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From page 397... ...
Seafood processing is limited to large tuna canning operations that maintain sufficient product quality and safety assurance programs. The per capita seafood consumption exceeds the average amount for the United States and includes tourist trade.
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From page 399... ...
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From page 400... ...
Regulatory agencies and state-based industry firms believe seafood production and processing in South Carolina do not pose any major seafood product safety concerns.
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From page 401... ...
Want more active than reactive regulatory program, especially for product integrity (i.e., species identification and incoming product quality)
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From page 402... ...
Increasing product demand and operational requirements for the regulatory agencies could compromise future surveillance for product quality and safety. The industry and respective regulatory agencies are content with the current "25mile line" distinguishing jurisdictions for inspection of fish processing, but this economic operational agreement could be compromised by steady-state and reduced budgets.
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From page 403... ...
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From page 404... ...
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From page 405... ...
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.
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From page 406... ...
There is no specific legislated authority to monitor postharvest product quality with the exception of molluscan shellfish.
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From page 407... ...
4. A condensed compilation of all related Texas regulations on seafood quality and seafood safety should be published for industry reference.
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From page 408... ...
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.
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From page 409... ...
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From page 410... ...
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From page 411... ...
Primary Product Safety Problems Molluscan shellfish safety-microbial consequences and PSP on the product and in the environment as encountered by both commercial and recreational interests.
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From page 412... ...
The primary seafood safety concerns are molluscan shellfish consumption and specific environmental contaminants. Washington State stands as an excellent example that regulation (inspection, surveillance)
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From page 413... ...
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From page 414... ...
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Key Terms
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