Oceans & Coastal Resources:
A Briefing Book
Congressional Research Service Report 97-588 ENR
Redistributed as a service of the National Library for the Environment

Seafood Safety and Inspection

Prepared by Geoffrey S. Becker

Specialist in Agricultural Policy
Environment and Natural Resources Policy Division.

Issue Definition
Background and Analysis
Status of the Issue
Continuing Concerns
Sources and References for Further Information

Issue Definition

While research has demonstrated the contribution of seafood to a healthy diet, the consumption of fish and shellfish also has been associated with a number of food-borne illnesses. Consumer advocates have long argued for stronger government programs to minimize such health risks. Others have countered that most seafood is, in fact, safe to eat, and that government officials already have the tools to effectively manage health risks. In fact, on December 5, 1995, the U.S. Food and Drug Administration (FDA), using its existing statutory authority, announced final rules imposing significant new seafood inspection requirements for processors and importers, which much of the seafood industry supports. At issue, among other things, is whether these rules will adequately address seafood safety, or whether additional regulation or legislation is needed.

Background and Analysis

Several consumer groups have argued that fish and shellfish pose a major health risk because, unlike meat and poultry products1 they are not required to undergo continuous federal inspection (see below). Opponents of extensive changes believe that more inspection would be too costly and impractical for seafood, which is harvested in the wild rather than raised on farms, and involves a far more diverse industry than meat and poultry. At any rate, opponents argue that more government inspection would not necessarily mean a safer product.

Seafood already is subject to federal inspection, but under a system markedly different from that for meat and poultry. The Federal Meat Inspection Act and the Poultry Products Inspection Act require U.S. Department of Agriculture (USDA) inspectors to be in plants at all times of operation to conduct "continuous" inspection; that is, to examine virtually every head of cattle, sheep, swine and goat, and all domesticated poultry at slaughter, and to visit daily all plants that further process them into edible products.

Although seafood is not subject to mandatory continuous inspection, several federal and state agencies have responsibilities to assure its quality and safety under a number of existing laws. FDA, which is in the Department of Health and Human Services, has a broad mandate under the Federal Food, Drug, and Cosmetic Act to ensure the safety of all foods in interstate commerce, including seafood. FDA also works cooperatively with states and industry in a voluntary shellfish sanitation program. The Commerce Department's National Marine Fisheries Service (NMFS) offers, for a fee, voluntary seafood inspection, mainly as a marketing and quality rather than safety program. The Environmental Protection Agency (EPA) has primary responsibility for reducing water pollution, a source of many seafood-borne contaminants.

What is the risk of eating seafood? According to health authorities, about 33,000 of the estimated 6.5-33 million cases of foodborne illnesses each year are likely caused by seafood. Earlier, in a 1991 report, an expert panel convened by the National Academy of Sciences (NAS) observed that seafoods accounted for 10.5% of all outbreaks (incidents involving two or more persons), and 3.6% of all cases (number of individuals who get sick), of food-borne illnesses reported by the CDC between 1978-1987. By contrast, cases of illnesses linked to other flesh foods--namely beef, turkey, pork, and chicken, were 4%, 3.7%, 2.7%, and 2.6%, respectively.

However, when considered separately, shellfish cases (2.3%) and fish cases (1.2%) were lower than for any of the other flesh food categories, according to NAS. The NAS reported that shellfish posed the greatest of all seafood-related risks. They were responsible for 31% of all seafood-borne outbreaks, but 66% of all seafood cases. Shellfish-borne disease is caused mostly by consumption of raw or undercooked mollusks, and stems from environmental contamination and naturally occurring vibrios (a type of bacteria).

Natural seafood toxins were involved in 62.5% of all seafood illness outbreaks but only 28% of cases. Such toxins are primarily ciguatera, from certain tropical reef-dwelling fish; scombroid poisoning, which develops in some fish species after harvest due to improper temperature control; and, to a lesser extent, paralytic shellfish poisoning. The NAS report also acknowledged the risks of consuming seafood contaminated by chemical pollutants, such as mercury, lead, PCBs, pesticides, but said that quantifying these risks is problematic because potential health effects (like cancer) generally emerge over a much longer period than acute illnesses.

NAS concluded, among other things, that most seafood risks originate in the environment and therefore should be addressed through regulation of harvesting and control of water quality. Also, problems are largely regional and/or focused on particular species.17

Status of the Issue

Advocates of seafood inspection legislation were unable to win enactment of a measure in the 101st or 102nd Congress, despite intensive deliberations and relatively widespread agreement among consumer and industry groups, and many lawmakers, that a more aggressive program would be desirable. Among other obstacles were disagreements over: which department (Health and Human Services, Commerce, or USDA) should have the lead; how stringent and comprehensive a new program should be; whether standards could and should be set for chemical and microbiological contaminants; and the cost of such a program, including who should pay for it.

Although interest in such legislation extended into the 103rd Congress, no major bill was actively considered. In the 104th Congress, the House Agriculture Committee was given new jurisdictional authority over seafood inspection. The Chairman of the panel's Subcommittee on Livestock, Dairy, and Poultry did express interest in seafood inspection changes as part of a broader bill to reform meat and poultry inspection procedures. However, his legislation (H.R. 4302)--which among other things would have brought seafood (and virtually all other flesh food species) under a uniform, mandatory USDA inspection system--did not attract widespread support.

In the absence of new legislation, the FDA moved administratively on seafood inspection, relying on its existing statutory authority. On December 18, 1995, the FDA published final regulations requiring seafood processors and importers to adopt so-called Hazard Analysis and Critical Control Point (HACCP) procedures to ensure the safety of fish and shellfish products. The HACCP process analyzes health and safety risks, determines how and where they should be prevented during production and handling, and concentrates oversight at these points. This is a departure from traditional food safety assurance, which relies on the detection, through spot checks and random sampling, of problems in food after they arise.

Under the new regulations, processors in the United States and those importing seafood here will be required to conduct an analysis of potential safety hazards. When hazards are found, they must prepare site- and product-specific "HACCP" plans which spell out: the hazards; the critical points where the hazards can be controlled; the safe operating limits for these critical points; how they will be monitored and problems corrected; and plant verification and record keeping procedures. The rules also delineate the types of corrective actions, verification, and records the plants can use, and set requirements for HACCP training and plant sanitation, among other things. Industry has 2 years from publication of the rules to comply.

Continuing Concerns

These concerns and questions are provided to stimulate further discussion of the issues noted above.

Industry officials, public health authorities, and others are hopeful that the new FDA regulations will provide the means to achieve a number of long-desired inspection objectives, and also preclude the need for new legislation. However, Congress eventually could be asked to resolve some longstanding policy questions that were left unresolved (or were not addressed) by the rules, at least in the view of some interests. Among those discussed:

  1. Will the new FDA program provide the appropriate type (and level) of inspection and monitoring, consistent with the NAS and other emerging research on hazards and risks? Some consumer advocacy organizations assert that the new FDA rules are not adequate, because inspectors will be relying primarily on industry-maintained records to ensure accountability. Government inspectors are not expected to significantly increase plant visits to check on sanitary conditions, advocates note. However, leaders of the industry support the new rules as a more scientific method for ensuring seafood safety.
  2. Should "whistleblower protection" protect industry employees? Labor and consumer advocates argue that such language, which is not included in the FDA rule, is needed under a HACCP-type system, because government inspectors would not be present at all times. Opponents counter that whistleblower protection for seafood industry workers would be overly burdensome and unfair to employers.
  3. NAS's chief findings pinpoint environmental causes as the most important health hazards. Should more attention be paid to environmental controls, including monitoring waters and those who harvest from them? What role, if any, should be played by EPA or other federal agencies?
  4. The new FDA rules do not require laboratory testing for chemical contaminants and/or microbiological hazards, which many critics believe is necessary for an effective inspection program--particularly HAGCP. However, because the seafood industry is far more diverse than meat and poultry, with hundreds of fish species already on the market, might it be too difficult to establish standards for all the potential chemical and microbiological contaminants? Can methods be developed now to more rapidly test for all such contaminants?
  5. Will federal budget constraints limit current or any future efforts to expand inspection? Should taxpayers pay most costs, as they do for meat and poultry inspection (as well as for the FDA's new but still less intensive program), or should industry (and ultimately, consumers) shoulder most of the costs, i.e., through user fees?
  6. How will the new program affect the structure and economic health of the industry? FDA has estimated that the required system will cost the entire seafood industry as much as $160 million to implement and $40-60 million annually to maintain. Seafood manufacturing plants are widely scattered, diverse, and small; three-quarters of the nearly 5,000 U.S. plants have annual sales below $1 million, according to FDA. Will smaller operations have more difficulty than larger ones in absorbing any increased compliance costs? At least a portion of the costs of complying with more stringent inspection ultimately would be passed through the marketing chain in the form of higher prices, potentially dampening demand. On the other hand, the new program could attract more consumers to fish and shellfish if they perceive that products will be safer.
  7. Critics contend that the new FDA program should not have exempted fishing vessels, retailers, and transporters of seafood. Should they have been subjected to more regulation, or will the current extent of coverage be adequate?
  8. What about aquaculture? Aquaculture, once considered a minor segment of the U.S. seafood industry, has grown rapidly in recent years. Some believe this growth has been at the expense of the wild-catch industry. Some have argued that aqua culture (which is fundamentally an agricultural enterprise) shares more similarities with meat and poultry production than wild fisheries, and therefore should be inspected under authority different from that for wild fish and shellfish.
  9. Which agency or agencies should have primary jurisdiction? Currently, four federal departments or agencies (HHS, Commerce, USDA, and EPA), along with many states, play important roles in seafood safety. Although the FDA rulemaking would seem to put that agency at the forefront, some believe that Congress should more explicitly delineate the responsibilities of the various agencies, including the designation of one as the lead on seafood. Others believe that each agency already plays a unique (and adequately defined role), making multiple jurisdiction more appropriate.
  10. Should seafood safety be debated in a broader context? A June 1992 GAO report observed that 12 federal agencies administer as many as 35 different laws to ensure food safety and quality. The report found that these agencies inconsistently inspect foods posing similar risks, inefficiently allocate inspection resources, sometimes duplicate each other's activities, and fail to adequately coordinate efforts. One option posed by GAO is the creation of a single food safety agency to administer a uniform set of food safety laws.18 Several bills were offered in the last Congress to combine inspection authority for all food under a single agency, but no action was taken on them. It might be argued that seafood inspection should be incorporated into more comprehensive food safety reform. On the other hand, as the FDA Commissioner and others have suggested, improvements in seafood safety assurance could serve as a prototype for the rest of the food industry--which already is closely observing the seafood safety debate.

Sources and References for Further Information

National Academy of Sciences, Institute of Medicine, Food and Nutrition Board. Seafood Safety. 1991.

U.S. Library of Congress, Congressional Research Service. Seafood Inspection Issues. CRS Report for Congress 95-290 ENR. [by Geoffrey S. Becker.] Washington, DC: Dec.19, 1995.

U.S. Library of Congress, Congressional Research Service. Food Safety: Issues and Concerns Facing Congress. CRS Report for Congress IB90096. [by Donna Vogt.] Washington, DC: updated periodically.


15 Prepared by Eugene H. Buck, Senior Analyst in Natural Resources Policy, Environment and Natural Resources Policy Division.

16 Prepared by Geoffrey S. Becker, Specialist in Agricultural Policy, Environment and Natural Resources Policy Division.

17 See: National Academy of Sciences, Institute of Medicine, Food and Nutrition Board. Seafood Safety. 1991.

18 U.S. General Accounting Office. Food Safety and Quality: Uniform, Risk-based Inspection System Needed to Ensure Safe Food Supply. GAO/RCED-92-152. Washington, DC: 1992.

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