Background

CDC estimates that contaminated food causes 76 million illnesses, 325,000  hospitalizations, and 5,000 deaths in the United States each year. On the  basis of the number of confirmed outbreaks of foodborne disease in 1997,  the latest year for which CDC’s data are available, seafood is one of the  leading causes of foodborne illness outbreaks in the United States. For  example, seafood products represented about 15 percent, or 26, of the 169  foodborne illness outbreaks with a confirmed source—a level greater than  that associated with meat and poultry products, which are consumed at,  respectively, 8 and 6 times the rate of seafood. However, CDC officials said  that foodborne illness outbreaks are generally underreported and that it is  easier to identify the source of some diagnosable illnesses, such as  scombroid poisoning from seafood, than illnesses resulting from some  nonspecific gastrointestinal symptoms caused by other foods. FDA also  noted that some seafood-related illnesses may be caused by fish caught  recreationally. The actual number of individual cases of illness resulting  from traced outbreaks were higher for meat and poultry (619 and 353  cases, respectively) compared with 108 cases for seafood. Seafood  outbreaks may have involved fewer individual cases of illness because  seafood has much lower consumption rates than meat and poultry.
Biological, chemical, and physical hazards can cause seafood-related  illnesses. Biological hazards include clostridium botulinum, listeria  monocytogenes, salmonella, and pathogenic staphylococcus. Chemical  hazards include compounds such as methylmercury, which can cause  illness from long-term exposure. Physical hazards include foreign objects  in food that can cause harm when eaten, such as glass or metal fragments.  According to FDA officials, two naturally occurring marine toxins with  potentially serious health effects—scombrotoxin and ciguatoxin—cause  most reported seafood-related illnesses, including gastrointestinal and  neurological problems. These naturally occurring toxins are biological in  origin but are categorized as chemical hazards, are heat resistant, and  cannot be inactivated by cooking. Appendix II provides additional  information on seafood-related illnesses and their symptoms.
Since 1980, seafood consumption in the United States has risen about 22  percent, from 12.5 pounds per person in 1980 to 15.3 pounds per person in  1999. According to data from the National Marine Fisheries Service, the  United States imported about 3.9 billion pounds of fishery products during  1999 from about 160 countries. The top five seafood-exporting countries— Canada, Thailand, China, Ecuador, and Chile—accounted for 50 percent of  the volume of imported seafood. Imported products include fresh and  frozen tuna and salmon as well as crustaceans, such as shrimp and  lobsters. Figure 1 shows the proportion of U.S. seafood imports from five  leading exporting countries.
FDA is responsible for ensuring the safety of both domestic and imported  seafood under the Federal Food, Drug, and Cosmetic Act (FFDCA). In  1997, following recommendations by the National Academy of Sciences  and others, FDA adopted a program of preventive controls designed to  identify hazards early in the seafood-production process and minimize the  risk of contamination. The HACCP regulations made seafood-processing  firms responsible for identifying harmful microbiological, chemical, and  physical hazards that are reasonably likely to occur and for establishing  critical control points to prevent or reduce contamination. The HACCP  system is based on seven principles that each seafood firm must address.
Conduct a hazard analysis. Identify hazards that are reasonably likely to  occur.
Identify the critical control points (CCPs). Identify a point, step, or  procedure in the production process where controls can be applied to  prevent, eliminate, or reduce a food safety hazard that is reasonably  likely to occur to an acceptable level.
Establish critical limits for each CCP. Set the maximum or minimum  value at which a hazard must be controlled at each CCP to prevent,  eliminate, or reduce the hazard to an acceptable level.
Monitor each CCP. Establish monitoring activities that will ensure that  the process is under control at each CCP.
Establish corrective actions. Define actions to be taken when  monitoring discloses a deviation from established critical limits.
Establish verification procedures. Establish verification procedures to  ensure that HACCP plans accomplish their intended goal—ensuring the  production of safe products.
Establish record-keeping and documentation procedures. Maintain  documentation, including the HACCP plan, CCP monitoring, critical  limits, and verification activities.
Under the HACCP rule, seafood-processing firms are responsible for  conducting a hazard analysis and for developing and implementing HACCP  plans for hazards determined to be reasonably likely to occur: natural  toxins, microbiological contamination, chemical contamination, pesticides,  drug residues, decomposition in certain species, parasites, unapproved use  of food or color additives, and physical hazards. For each hazard identified,  the firms must establish critical control points to prevent or reduce  contamination. Firms must also establish and monitor sanitation  procedures to ensure, among other things, the (1) general cleanliness of  food contact surfaces, including utensils, gloves, and outer garments, and  (2) control of employee health conditions.
To assist industry with HACCP compliance, FDA published the Fish and  Fisheries Products Hazards and Controls Guide, which discusses, among  other things, how to perform a hazard analysis, develop a HACCP plan, and  identify critical control points. The guide provides species-specific and  process-related examples of hazards reasonably likely to occur, but as its  name suggests, this document is only guidance; seafood firms are not  required to follow it. The guide, according to FDA, has been translated into  other languages, is used by regulatory authorities in other countries, and  has served as a catalyst for discussions between the seafood industry, other  interested stakeholders, and FDA about the scientific merits of hazards and  controls.
According to the National Fisheries Institute, seafood firms generally  support the HACCP system because it has, among other things, caused the  industry to look at how best to manage hazards and how to look at food  safety from a science-based perspective—for example, what hazards are  likely to cause illness, how frequently people are becoming ill, and how  serious those illnesses are. Also, according to FDA, two surveys of the  industry taken by the New York Sea Grant Extension program and others  report that in response to HACCP, the industry is engaging in upgrades to  facilities, equipment, and daily plant operations to ensure safety.
To help implement and oversee HACCP systems, for industry personnel  and FDA inspectors, FDA developed a training and certification program  that is intended to ensure that they have the necessary expertise to  evaluate HACCP systems. The training program is offered by the National  Seafood HACCP Alliance—an academic, government, and industry  consortium. The Alliance’s course is the standardized curriculum by which  FDA evaluates other HACCP courses; it contains the information necessary  to meet the HACCP-training requirements. Course participants receive a  certificate. The seafood HACCP regulations require that industry personnel  responsible for developing HACCP plans, reassessing and modifying the  plan, and performing record reviews successfully complete training in the  application of HACCP principles for fish and fishery products at least  equivalent to those received under the FDA-approved course. However, the  regulations also state that job experience will qualify an individual to  perform these functions if he or she has provided knowledge at least  equivalent to that provided through the standardized curriculum.
FDA periodically inspects seafood firms to check on their sanitary  conditions and to verify compliance with the HACCP requirements. To  determine whether seafood firms identify all safety hazards and whether  they are consistently controlling those hazards, FDA inspectors survey the  plant and then review the HACCP records. From 1998 through 1999, FDA  inspected all seafood firms in its inventory at least once to verify  compliance with the new HACCP-based system. In the budget for fiscal  year 2000, Congress provided $267 million for FDA’s food programs—a $32  million increase over FDA’s budget for fiscal year 1999. Some of this  increase was to enhance the coverage of both domestic and imported  foods, including the increased inspection of high-risk food and continued  implementation of the HACCP requirement for seafood. While FDA  believes that additional funds are needed to ensure the safety of the food  supply, it now inspects seafood firms annually. Prior to these annual  inspections, FDA inspected seafood firms once every 4 years on average,  according to FDA officials.
Generally, FDA personnel inspect one or two seafood products at each firm  inspected. The number of seafood products handled by each firm varies.  According to FDA, seafood-processing firms collectively handle over 350  species of fish. For example, the seafood firms that we visited in Norfolk  and Philadelphia processed a wide range of products, including fresh and  frozen fish, such as salmon, tuna, bluefish, mahi-mahi, mackerel, and  grouper; crustaceans, such as lobster and crabs; and shellfish, such as  oysters and clams. FDA’s policy was to give priority to inspecting products  considered to be high-risk, including  vacuumed-packaged seafood (these products are subject to the growth  of Clostridium botulinum, a toxin producing bacteria);  ready-to-eat seafood, such as cooked shrimp and crabmeat and hot or  cold smoked fish (these products are subject to the growth of pathogens  from post-process contamination);  histamine-forming species, including mahi-mahi, tuna, and bluefish  (these products are subject to histamine formation—a toxic substance);  and  stuffed seafood products (processing and handling may allow toxins to  develop in these products).
FDA can take several regulatory actions when firms are cited for HACCP  violations. For example, if in the agency’s judgment the violation cited is of  regulatory significance, it may issue the firm a warning letter. FDA issues  warning letters in cases where violations raise safety concerns that may  lead to enforcement action, such as product seizure or injunction (a court  order to refrain from distributing a product), and/or prosecution if not  promptly and adequately corrected. In the case of importers, a warning  letter could advise them of a forthcoming detention. Firms that receive  warning letters are asked to respond to FDA in writing within 15 working  days to indicate what actions will be taken to correct the problems  identified. If the firm does not correct the violation promptly and  adequately, FDA can pursue enforcement actions, such as product seizure  or injunction through the courts.
In 1996, USDA issued HACCP regulations for meat and poultry firms.  However, before implementing HACCP, USDA established the prevalence,  or baseline, levels for a number of microbial organisms in meat and poultry,  including salmonella, E-coli, listeria, and campylobacter. These baseline  data provided USDA with a starting point for evaluating the effectiveness of  HACCP in terms of lowering the bacterial levels in the product. For  example, USDA regularly collects and tests samples of meat and poultry  products for the presence of salmonella and then compares the results with  pre-HACCP baseline data.

	Domestic Seafood Safety System Does Not Effectively Protect Consumers From Unsafe Seafood

FDA has made some progress in ensuring the safety of domestic seafood  consumed by the public. According to FDA’s December 2000 report on the  evaluation of the HACCP system for seafood, the percentage of seafood  firms with a HACCP plan that included all of the required components  increased from 31 percent in 1998 to 44 percent in 1999. However, FDA  recognizes that gaps still exist in HACCP’s implementation and that certain  segments of the industry are lagging behind. Our evaluation shows that  several flaws in FDA’s system for ensuring the safety of domestic seafood  may allow unsafe seafood products to reach consumers. First, a significant  number of seafood firms and/or products are not operating under the  HACCP regulations. Second, even when seafood-processing firms are  subject to HACCP requirements, FDA inspections do not fully evaluate the  firms’ operations because such inspections were frequently limited to a  paperwork review rather than actual observation of product processing.  Furthermore, at both these inspections and those where FDA observed the  processing of products subject to HACCP requirements, the agency found  that over half of the HACCP plans had serious violations. Third, when  violations of regulatory significance were identified, FDA did not take  timely action to issue warning letters notifying seafood firms that they must  correct the violations promptly and adequately to avoid further  enforcement action, such as seizure or injunction. Finally, FDA lacks, and  has no immediate plans to obtain, the basic information needed to assess  the effectiveness of its HACCP requirements to ensure the safety of  seafood.

		Many Seafood Firms Are Excluded From HACCP Requirements

HACCP regulations apply to all seafood-processing firms, but a significant  number do not operate HACCP systems. As a result, the benefits of  HACCP—identifying and controlling food safety hazards—are not being  fully obtained, thus placing consumers at risk of consuming unsafe  seafood.
While FDA is responsible for overseeing all seafood-processing firms  operating in interstate commerce, it does not have an effective system to  identify such entities because it does not have a registration requirement  for seafood firms. Although the exact number of seafood firms under FDA’s  jurisdiction is unknown, industry and government officials believe it is  larger than the approximately 3,600 or so seafood firms in FDA’s official  inventory. FDA officials stated that the agency has the authority to register  some seafood-processing firms under its authority to impose emergency  permit control regulations. However, the agency does not require  registration of any seafood-processing firm except those that process low- acid or acidified canned food. FDA uses a variety of ways to identify  seafood firms under its jurisdiction, including checks of the telephone  book yellow pages, newspapers, magazines, trade periodicals, state  inventory records, and consumer complaints. However, we reported in the  past that such identification efforts are time-consuming, costly, and  ineffective and pointed out to FDA that a simple registration system based  on a requirement that processors operating in interstate commerce notify  FDA when they begin operations would cost little.
Furthermore, while all land-based seafood-processing firms are subject to  HACCP requirements, thousands of commercial fishing vessels are exempt,  even though they may present hazards and risks similar to those posed by  land-based seafood-processing firms. FDA’s HACCP regulations exempt  vessels that (1) harvest and transport fish without any further processing  and (2) head, eviscerate, or freeze fish on board solely to prepare them for  holding. Fishing vessels that process fish beyond these provisions, (e.g.,  factory ships that fillet or pack their catch), are subject to HACCP  requirements. Currently, FDA’s inventory shows that 250 vessels are subject  to HACCP requirements. However, the number of vessels that should be  subject to HACCP requirements and inspections is not known because  neither FDA nor any other organization we contacted has information on  vessels that process fish on board. An official for the state of Alaska noted  that the number of vessels that process fish on board and are thus subject  to state inspections is almost twice as large as the number of vessels in  FDA’s inventory. Also, an official in one of FDA’s district offices noted that  from 400 to 800 fishing vessels in his district may perform some type of  processing.
FDA officials said they decided to exempt most vessels from the regulatory  definition of “processors” and thus exempt them from HACCP regulations  because of practical considerations. Namely, the fishing fleet is so large  that FDA believes that inspecting the fleet would overwhelm the inspection  system. FDA also believes that if it requires the fleet to comply with  HACCP requirements, some fishing vessels may decide to avoid heading  and gutting fish on board. FDA officials said that this would pose a greater  risk for product safety and quality. While these observations have merit, the  HACCP regulations are intended to cover the heading, eviscerating, or  freezing of seafood products so that hazards reasonably likely to occur  during these processing steps may be controlled.
Finally, about one-third of the seafood products FDA inspected are not  required to have a HACCP plan, including many products at warehouses  and repacking firms. Under the seafood HACCP regulations, seafood- processing firms are required to identify the food safety hazards that are  reasonably likely to occur and implement measures to control these  hazards; then FDA inspectors independently make a similar assessment  during their inspections. If the seafood firm determines and the FDA  inspector agrees that no hazards are reasonably likely to occur, the seafood  firm is not required to have a HACCP plan for the products inspected. FDA  inspectors may determine that a firm does not need a HACCP plan because,  in their view, the product is of low risk.
According to FDA’s statistics for inspections in 1999, HACCP plans were  not required for 30 percent, or 1,055, of the 3,525 products inspected  because the inspector determined that no hazards were reasonably likely to  occur. For example, on the basis of the seafood hazards guide, FDA  inspectors concluded that there were no risks associated with 516 products  because storage at warehouses and repacking firms did not present a  significant hazard. Therefore, HACCP plans were not needed for seafood  products at these locations. FDA officials said that most warehouses do not  handle high-risk products, such as scombroid species. However,  temperature controls for refrigerated products are very important to  prevent certain hazards, such as botulism in smoked vacuum-packed  products or scombroid poisoning in certain fish species. FDA officials said  that final product storage, especially for nonfrozen product, is a weakness  at some seafood firms because refrigeration problems, such as equipment  breakdowns or uncalibrated thermometers, may prevent these firms from  keeping seafood products at appropriate temperatures. Our review of a  sample of FDA inspection reports from three districts verified that some  firms experience problems ensuring that temperatures are maintained. For  example, we estimate that in about 30 percent of these reports, FDA  inspectors found that instruments such as freezer and cooler thermometers  were not properly calibrated. Without a HACCP plan with critical controls  and monitoring procedures, such problems may go undetected for  prolonged periods of time and jeopardize product safety.
In contrast, USDA’s regulations for meat and poultry products require that  every plant in its inventory of approximately 5,700 plants, identify at least  one critical control point for each identified hazard. Agency officials said  they are not aware of any meat and poultry operations that can be deemed,  categorically, to pose no likely hazards. Some USDA officials involved  with meat and poultry regulation, including the Assistant Deputy  Administrator for District Enforcement Operations, stated that it is difficult  to understand how no hazards are likely to occur in seafood firms.

		FDA Is Not Effectively Ensuring HACCP Implementation

FDA uses on-site unannounced inspections to assess a firm’s compliance  with HACCP requirements. As part of this process FDA inspects the  general sanitary conditions of the firm and equipment. Critical components  of the inspection also include an evaluation of HACCP plans, review of  HACCP records, and in-plant observations of the product selected for  inspection. However, we found that FDA inspectors frequently could not  conduct in-plant observations of the selected product. We estimate that in  almost half (48 percent) of the seafood inspections at three FDA districts in  fiscal year 1999, the selected product was not being processed on the day  of the inspection. In other words, FDA inspectors did not make an in-plant  observation of the product but instead conducted a paperwork review. FDA  officials said that because inspections are unannounced, there were  instances where the product selected was not being processed and FDA  inspectors were limited to a review of plant records to verify compliance.  FDA’s compliance manual recommends that inspectors return to physically  inspect the product if at the time of their plant visit, the product was not  being processed. However, FDA inspectors generally did not return to the  firm to inspect the products originally selected for inspection. Officials in  the three districts we visited said that, as a general rule, insufficient  inspection resources prevent them from returning to observe the selected  product. FDA inspection records did not show such follow-up inspections,  and FDA inspectors told us they did not conduct them. In an October 1999  memorandum to FDA District Directors, FDA acknowledged the need to  observe the selected product during processing by stating that HACCP  inspections emphasized the need for more in-plant observations of the  selected products. An FDA official explained that inspectors should spend  most of their inspection time observing the selected product in the  processing environment, especially those that are considered high-risk.
In addition, almost 3 years after HACCP was implemented, FDA’s data on  industry compliance shows that many seafood firms have yet to meet the  basic requirements for a HACCP plan. That is, 22 percent (542 of 2,470) of  the products inspected by FDA in 1999 that required a HACCP plan did not  have one. Of those that did have a HACCP plan as required, FDA’s data  show that more than half (1,080 of 1,928) contained serious deficiencies,  according to FDA inspectors. The plans were judged to have serious  deficiencies because, according to FDA’s compliance manuals, they (1) did  not identify hazards that FDA considers serious, such as pathogens and  toxins; (2) did not identify an appropriate critical control point where the  hazard could be controlled; (3) did not identify an appropriate critical limit,  or operating parameter for the critical control point; (4) did not identify  appropriate monitoring procedures; (5) did not identify appropriate record- keeping procedures; and (6) did not identify adequate corrective action  procedures.
According to FDA officials, the grading system used for this evaluation  required that HACCP plans have all five of the most significant components  adequately addressed and, therefore, was a rigorous evaluation of the  industry’s compliance. FDA said that it was not easy for seafood firms to  score 100 percent on all elements, even though they succeeded in many of  the individual elements. In general, FDA believes that it will take time for  all of the seafood firms subject to HACCP regulations to fully comply with  the requirements. In its December 2000 HACCP evaluation report for  seafood, FDA said it would intensify its inspection efforts to focus on  improving compliance.
Our analysis of a probability sample of inspections’ records from three FDA  districts yielded similar results. We estimate that in about 55 percent of the  FDA inspections of products with HACCP plans, the inspector found one or  more serious violations. Table 1 summarizes the type and estimated  frequency of the violations identified by FDA inspectors.
The potential health risks associated with these violations are significant  because they can involve the failure to establish critical limits for high-risk  products, such as cooked ready-to-eat seafood. The failure to establish  cooking critical limits for cooked ready-to-eat products can allow  pathogens such as listeria monocytogenes to survive, and possibly cause  listeriosis—a serious and often fatal condition to humans. FDA’s  compliance data for fiscal year 1999 show that 40 percent of the HACCP  plans covering cooked ready-to-eat products did not establish adequate  time and temperature critical limits to prevent, reduce, or eliminate these  types of hazards.
Even if the plans were complete, according to FDA requirements, they  would still omit a serious hazard because methylmercury, a highly toxic  substance, is not identified or covered in FDA’s seafood guide as a hazard  reasonably likely to occur. According to a July 2000 National Research  Council report, contaminated fish is the major source of human exposure  to methylmercury in the United States and can cause, among other things,  serious neurological problems, such as mental retardation in young  children. The risk to public health posed by methylmercury is based on  how much of the contaminant is in fish and how much fish people eat.
FDA’s guidance to industry does not discuss the identification and control  of methylmercury even though FDA’s tests for methylmercury in shark and  swordfish found that 9 of 18 samples analyzed in 1998 and 1999 met or  exceeded FDA’s 1.0-part-per- million action level. These test results  pertained to imported products.
FDA officials said that most commercial seafood species have very low  levels of methylmercury. They also said that the species that contain the  highest average amounts of methylmercury—shark and swordfish—are  expensive and, therefore, consumed infrequently. Thus, FDA considers  that, in most species, methylmercury is not a hazard that is reasonably  likely to occur and that HACCP controls are not needed. Furthermore,  FDA’s position is that if there were an industrial incident or similar event  that could raise the levels of mercury in commercial seafood, they would  examine whether HACCP controls are warranted and issue new guidance  as necessary.
FDA has been evaluating new data on the health effects of methylmercury  from the consumption of fish. However, the agency has not established a  timeline for completing its evaluation. Moreover, FDA officials stated that  the agency is unlikely to include any guidance to industry in the next  edition of its Fish and Fisheries guide to be issued in calendar year 2001. In  the meantime, FDA advises industry and inspectors not to identify  methylmercury as a hazard reasonably likely to occur. However, before  HACCP’s implementation, FDA’s draft Fish and Fisheries Guide identified  methylmercury as a potential hazard in certain seafood species consumed  by humans, including swordfish and tuna. Furthermore, in 1995, FDA  updated its consumer advisory warning pregnant women and women of  childbearing age to limit their consumption of shark and swordfish because  of potential methylmercury contamination. In January 2000, FDA revised  its methylmercury advisory and now recommends that women who are  pregnant, or who are of childbearing age and may become pregnant, avoid  eating the four species of fish known to have the highest levels of  methylmercury: shark, swordfish, king mackerel, and tilefish.
Even when FDA identifies serious violations at a seafood-processing firm,  it does not take timely regulatory action to ensure compliance. When  interactions between inspection personnel and plant personnel fail to  obtain compliance, warning letters are the principal means of notifying the  plants of serious violations and achieving prompt corrective action before  proceeding to more stringent enforcement actions. Warning letters are to  be issued for violations of regulatory significance—i.e., violations that  affect product safety and may lead to enforcement action, such as product  seizure or injunction, if not promptly and adequately corrected. To ensure  the prompt and adequate correction of serious violations, FDA’s regulatory  procedures manuals state that warning letters should be approved within  15 working days of the receipt of the district office’s recommendation.
According to FDA’s analysis of 52 warning letters processed in calendar  year 2000, 94 percent, or 49, exceeded recommended issuance time frames  thus significantly delaying notification to industry of observed problems  that needed correction. On average, 73 days elapsed between the receipt of  the district offices’ recommendation and the approval of the warning  letters.
Our analysis of 162 warning letters issued to domestic firms nationwide  after inspections conducted in fiscal year 1999 parallels these findings— that is, three-quarters of the letters exceeded the issuance time frames by  30 days or more. More significantly, we found that 67 percent of these  letters were associated with high-risk products, including scombrotoxin- susceptible seafood, which, if not properly handled, could cause serious  health problems requiring hospitalization, particularly in the case of elderly  individuals.
FDA headquarters officials explained that issuance time frames are  exceeded primarily because of the need to ensure that recommendations in  district offices’ warning letters are consistent with agency policy. They  explained that changes in agency policy are sometimes necessitated by  changes in the science associated with HACCP systems and that, in some  cases, a significant amount of time is needed to review new or updated  policy to ensure that it is interpreted correctly. Also, a significant number  of the recommendations in the domestic warning letters submitted by the  districts require changes because the letters did not correctly cite serious  or critical deficiencies. FDA district officials cited an increase in the  number of warning letters issued and the lack of adequate resources as  reasons for not meeting the issuance time frames for warning letters. In  this regard, an October 1999 FDA memorandum states that an analysis of  recommendations in warning letters showed that only 5 percent of the  district offices’ draft warning letters were approved as written. On the basis  of its review, FDA headquarters provided a summary of the problems  identified to field personnel and boilerplate language to be used in warning  letters to help correctly communicate the problems identified during  inspections.

		FDA Lacks Information to Assess the Effectiveness of HACCP Requirements for Seafood

FDA lacks objective, measurable data to determine whether its HACCP  program for seafood is effectively reducing hazards. Currently, neither FDA  nor the industry is required to collect such data, and FDA officials said that  they have no plans to require data collection in the future because seafood  products are subject to many different hazards, making it difficult to select  one or more to measure.
A guiding principal of the Government Performance and Results Act is the  development and use of objective and measurable performance measures  to demonstrate results on how well an organization is achieving its goal. In  this regard, prior to the implementation of its HACCP program, USDA  determined the prevalence of salmonella—a microbial organism—in meat  and poultry so that it could evaluate whether HACCP requirements were  effective in lowering salmonella levels. USDA set targets for reducing the  incidence of salmonella contamination in meat and poultry products by  establishing performance standards. Recent USDA reports show that,  under this program, the levels of salmonella contamination in meat and  poultry are declining.
FDA has no baseline data or requirement to systematically measure any  changes in the level of seafood contaminants, although the agency did test  a limited number of seafood samples for surveillance and compliance  purposes. In 1999, FDA analyzed a total of 769 domestic seafood samples  (of which 473 were analyzed for the presence of biological hazards) and  found that 94, or 20 percent, contained hazards such as salmonella, listeria,  and scombrotoxin. FDA officials said that, unlike meat and poultry,  seafood is affected by a variety of microbiological and chemical pathogens  and that there is no single widespread bacterial hazard, such as salmonella,  in meat and poultry.
While all seafood may not be affected by a single widespread hazard, such  as salmonella, some species of seafood are often affected by specific  hazards. For example, tuna, mahi-mahi, and bluefish are likely to produce  histamines when not kept at the proper temperature. The resulting  illness—scombroid poisoning—causes nausea, diarrhea, sweating, and  headaches. Similarly, subtropical and tropical fish, including grouper and  snapper, accumulate a naturally occurring toxin, called “ciguatoxin.”  Ciguatera poisoning involves a combination of gastrointestinal  neurological and cardiovascular disorders. Scombrotoxin and ciguatoxin,  which cannot be eliminated by cooking, contributed to over 88 percent of  all confirmed food illness outbreaks for seafood reported by CDC in 1997.
While FDA does not have a performance-based method for measuring  reductions in seafood-related hazards, it does collect data on seafood firms’  compliance with regulatory requirements and uses those data to evaluate  progress. For example, in 1992, FDA compiled descriptive compliance data  from seafood firms that handled high-risk products. The data describe the  processes in place, such as the types of monitoring systems, and some of  the problems identified in 1992, such as the extent of sanitation violations.  Although FDA compared HACCP compliance data from 1998 and 1999 with  the 1992 data, the results do not objectively measure whether seafood  produced under the HACCP system has experienced measurable reduction  in contamination.

	FDA’s Approaches to Ensuring the Safety of Imported Seafood Are Not Effective

As with domestic products, FDA’s approaches for ensuring the safety of  imported seafood provide only limited protection against unsafe seafood  reaching consumers. First, FDA has been unable to develop equivalence or  compliance agreements that document foreign countries’ equivalence or  compliance with the U.S. seafood safety system. Second, FDA’s reviews of  importers’ documentation have shown that many do not have records of  foreign seafood firms’ compliance with U.S. requirements for HACCP  programs as is required in the absence of equivalence agreements. When  documentation has been available, it often did not adequately demonstrate  such compliance. Third, although FDA inspects some foreign firms and  often finds serious deficiencies, it does not take follow-up actions, such as  automatically detaining products from these firms at U.S. ports. Fourth,  FDA’s traditional strategy of visually examining and/or testing imported  seafood at U.S. ports has been widely discredited as an effective method  for ensuring the safety of imported foods. Moreover, FDA’s port of entry  examinations and testing are unable to keep pace with the growing level of  imports.

		FDA Lacks Country-to- Country Equivalence Agreements

FDA has authority to enter into voluntary agreements with individual  countries recognizing the equivalence or compliance of their seafood safety  systems. Moreover, under the provisions of the World Trade Organization  Agreement on the Application of Sanitary and Phytosanitary Measures  (SPS Agreement), the agency is obligated to at least take equivalence  requests from other countries under consideration. FDA defines  equivalence agreements as those in which FDA finds one or more of an  exporting country’s requirements equivalent to our own.
Currently, however, FDA has no equivalence or compliance agreements  with countries that export seafood to the United States, although the  agency has compliance agreements for molluscan shellfish (fresh and  frozen oysters, clams, mussels, and whole or roe-on scallops). FDA  officials said that they have received requests for equivalence  determinations from approximately 30 countries that export seafood to the  United States. After an initial review, FDA concluded that 8 of the 30  interested countries were viable candidates and is now discussing  equivalence agreements with Australia, Canada, and New Zealand and a  compliance agreement with Japan. However, FDA has not developed a  timetable for completing these agreements. Furthermore, according to  FDA officials, the agency is considering how seafood safety processes or  procedures might change, should it complete an equivalence agreement,  but has not made any decisions yet. Specifically, the agency is considering  (1) adjusting the rate at which the agency examines imports at ports of  entry in order to focus more attention on imports from countries not yet  found to be equivalent, (2) having a standing arrangement for immediate  inspection by the regulatory authority in the exporting country whenever a  problem is found with a product being offered for entry into the United  States, and (3) the frequency of on-site audits in countries with which the  agency develops equivalence agreements.
FDA officials acknowledge that equivalence agreements would help ensure  that adequate safety and sanitation standards exist for imported seafood.  FDA officials said that the United States and Canada have had discussions  and have engaged in activities aimed at determining the equivalence of the  two systems. These discussions began in the summer of 1997. FDA and  Canadian officials would not discuss in detail the ongoing deliberations  regarding each other’s system. They said that the time required to  determine equivalence is partly due to Canada’s changes to its seafood  safety system in 1997 that required a reevaluation by FDA. However,  Canadian concerns with the U.S. system also contributed to the long  discussions. Officials of the Canadian Food Safety Inspection Agency said  that during their on-site visit of U.S. seafood plants, they identified a  number of areas of concern with the U.S. system, such as FDA’s not  verifying the adequacy of HACCP plans before seafood firms implemented  them. In Canada, seafood firms must submit their HACCP plans to the food  inspection agency for review before they are implemented. Appendix III  provides further information on selected aspects of the U.S., Canadian, and  Chilean seafood safety inspection systems.
Unlike USDA, FDA is not legally required to certify that countries that  export food products to the United States have safety, sanitation, and  inspection programs that provide an equivalent level of safety to that of the  U.S. system. Under the meat and poultry inspection acts, USDA’s Secretary  of Agriculture must certify that exporters of meat and poultry products  have equivalent food safety systems before their products can be exported  to the United States. As of January 1, 1998, the Secretary had certified that  37 countries had equivalent systems. In our 1998 report on imported food  safety, we concluded that the lack of equivalence requirements for FDA- regulated imported foods adversely affects the agency’s ability to keep  unsafe foods out of U.S. commerce. We recommended that Congress  strengthen FDA’s ability to ensure the safety of imported foods by requiring  that all food eligible for importation to the United States—not just meat  and poultry—be produced under equivalent food safety systems. Because  equivalence agreements with major exporters of seafood to the United  States are lacking, FDA relies on a review of paperwork at importers’  offices to attempt to determine whether importers have met their  responsibilities and requirements under the seafood HACCP regulations.  While legislation was introduced in 1999, Congress has not yet acted to  strengthen FDA’s ability to ensure that imported foods, including seafood,  be produced under equivalent safety systems.

		Most Importers Lack Required Documentation to Demonstrate Compliance With HACCP Requirements

In the absence of any seafood equivalence agreements between the U.S.  and foreign countries, federal regulations hold importers responsible for  demonstrating that the seafood they bring into the United States is  produced under systems that are equivalent to or compliant with HACCP  requirements for domestic seafood. The HACCP regulations for seafood  require importers to obtain products from a country with which FDA has  an equivalence agreement or to take affirmative steps to document foreign  firms’ efforts to comply with the U.S. requirements. Figure 2 shows  regulatory requirements for importers and the documentation they can use  to demonstrate compliance. However, less than a third of the importers  that FDA inspected met these requirements, according to our analysis of  FDA’s inspection records of importers for fiscal year 1999.
We found that importers had the required product documentation for less  than one-third of the products inspected. That is, only 27 percent (116 of  432 seafood products) listed in the FDA inspection forms showed that the  importer had (1) a written product specification document and (2)  documentation for at least one of the six possible affirmative steps required  by the regulations. Of those that had the required documentation on file, 57  percent (66 of 116) had a copy of the foreign firms’ HACCP plan and written  guarantee, and 50 percent (58 of 116) had a copy of a lot-by-lot certificate  from the foreign government’s inspection authority. Few importers (16  percent, or 18 of 116), chose regular inspections of the foreign processor’s  facilities as a method for demonstrating compliance.
Furthermore, the FDA inspection forms showed that, in many cases, the 66  HACCP plans that the importers obtained did not identify hazards that,  according to FDA’s seafood guide, are reasonably likely to occur, although  exceptions may occur in each specific case, as shown in the following  examples: Thirteen of the HACCP plans were for scombroid species (tuna, mahi- mahi, and bluefish), but only 6 identified scombrotoxin as a hazard  reasonably likely to occur. FDA’s seafood guide states that it is  reasonable to assume that, without proper controls, these species of fish  will contain unsafe levels of histamine, resulting in the formation of  scombrotoxin.
Twelve of the HACCP plans were for shrimp, which may contain  sulfites—a chemical hazard, but only 3 identified any chemical hazards  as being reasonably likely to occur.
Fifteen of the HACCP plans described processing steps, such as filleting  and mixing, that can present physical hazards, such as metal fragments.  But only two of those HACCP plans identified such hazards.
Eight of the HACCP plans involved such species as grouper, mackerel,  and snapper, which can carry ciguatoxin, but none of them identified  ciguatoxin as a hazard that was reasonably likely to occur. Ciguatoxin is  one of the leading causes of seafood-related illnesses, according to  CDC’s data.
FDA issued warning letters to 33 importers for serious deviations from the  HACCP regulations. Forty-eight percent (15 of 33) of the warning letters  noted repeat violations from the previous inspection, such as the failure to  adequately perform one of six affirmative steps and the failure to have  written product specifications.
To further ensure the safety of imported seafood, FDA issued an import  alert in January 1998 that is to be used to detain seafood products destined  to importers that did not verify foreign seafood firms’ compliance with U.S.  HACCP requirements. The import alert is to be adjusted to include  importers that do not meet HACCP requirements. However, despite the  number of violations identified by inspectors and noted in warning letters  to seafood importers, FDA had listed only two of these importers on the  alert. FDA’s recently released report on its seafood program acknowledges  that importers have experienced problems with major provisions of the  importer requirements, but FDA officials said that educating importers on  their responsibilities is important. FDA’s strategy is to provide importers  with additional information about HACCP requirements, coupled with FDA  enforcement.

		FDA Does Not Take Enforcement Actions on Deficiencies Identified in Its Overseas Inspections

FDA conducts limited inspections of selected foreign seafood firms to  determine the firms’ compliance with the agency’s seafood regulations.  FDA personnel visited four foreign countries in fiscal year 1999—Ecuador,  Vietnam, Taiwan, and the Philippines—to inspect 37 seafood firms and to  provide education on the U.S. HACCP requirements. None of these foreign  visits were conducted for equivalence determination purposes. During  those inspections, FDA found numerous HACCP-related problems, and  issued 24 warning letters to foreign firms. However, only about half of them  responded to FDA’s letters. To date, FDA has not taken further enforcement  actions against the nonresponding firms. Table 2 provides examples of the  types of problems that FDA found during these inspections.
When FDA notes deficiencies during foreign visits and they are not  corrected, FDA can place the foreign product under import alert and detain  it at the U.S. port of entry for further examination and testing. In 1998, FDA  issued a generic import alert to cover all foreign firms that do not comply  with HACCP requirements. An official in FDA’s imports office said that he  is unaware of any instances where deficiencies identified by the Office of  Seafood and the Office of Regulatory Affairs during foreign country visits  were communicated to the imports office. If the deficiencies had been  communicated, the import alert could be updated to ensure that products  from foreign firms where problems were identified could be subjected to  increased scrutiny at the port of entry. After we discussed this matter with  senior FDA officials, FDA added nine firms to the import alert and is in the  process of adding another firm. Nonetheless, FDA believes that the foreign  seafood firms they visited are making progress in learning and complying  with the new HACCP requirements.

		Port of Entry Inspections Are Widely Discredited

FDA may detain individual shipments at U.S. ports of entry so it can  conduct visual examinations and/or collect and test product samples while  it determines if the product is misbranded or adulterated. However, port of  entry inspections for imported food have been widely discredited as an  effective means for ensuring product safety. Furthermore, FDA’s port of  entry examinations have been unable to keep pace with the growing  volume of seafood product imported into the United States.
According to the U.N. Food and Agriculture Organization, testing products  at the port of entry involves a concentration of inspection resources on the  imported product itself and is an attempt to compensate for a lack of  knowledge about the producer’s processing, hygiene, and sanitation  practices. Recognizing the limitations of this method, FDA’s draft guidance  on equivalence criteria states that, by itself, the end-product inspection and  testing at the port of entry cannot be relied upon to provide adequate  protection. In our 1998 report on imports, we also reported that reliance on  end-product testing is an ineffective, resource-intensive, and statistically  invalid approach to ensuring the safety of imported food. We made a  number of recommendations to improve the effectiveness of FDA’s port of  entry-inspection system, such as providing inspectors with more consistent  and accurate data for selecting imported products for inspection but  emphasized that FDA’s reliance on port of entry inspections was an  ineffective means for ensuring the safety of imported food. Therefore, to  strengthen FDA’s ability to ensure the safety of imported food, we  recommended that Congress require all food eligible for importation to the  United States—not just meat and poultry—be produced under equivalent  food safety systems.
Furthermore, FDA’s port of entry inspections are unable to keep pace with  the growing volume of imported seafood products. For example, from 1998  through 1999, imported seafood products increased by 7 percent (from 3.6  billion to 3.9 billion pounds), while the proportion of foreign seafood  entries detained for visual and/or laboratory examination decreased from 5  to 3 percent. In 1999, less than 1 percent of imported seafood entries were  subjected to the laboratory portion of the examination. According to FDA  officials, insufficient resources and an increased volume of imported  seafood products resulted in the reduced rate of FDA port of entry  inspections and tests of imported seafood products. While increased  resources would be helpful, as we have previously reported, the most  effective method to ensure the safety of imported seafood is to certify that  imported products are produced under equivalent food safety systems.

	Conclusions

Since FDA first issued the HACCP regulations for seafood, seafood- processing firms have made some progress in implementing the new  system. However, several important weaknesses compromise the overall  effectiveness of the federal seafood safety system. If left uncorrected, they  will continue to undermine the goal of HACCP systems—that is, controlling  hazards in the production process before the product reaches the market.  More importantly, U.S. consumers may continue to be placed at risk of  contracting foodborne illness from contaminated domestic and imported  seafood products.
Without requiring registration of all domestic seafood firms, FDA cannot  effectively ensure that all seafood products are processed under the  HACCP regulations. Similarly, FDA cannot ensure that all seafood products  are operating under HACCP systems if it continues to exclude vessels that  meet its criteria for land-based seafood firms. Unless FDA verifies that  industry identifies and controls all hazards reasonably likely to occur, it  cannot ensure that industry is implementing an effective HACCP system.  And without the actual observation of the seafood products selected for  inspection, FDA inspectors cannot ensure full compliance with HACCP  requirements. Also, without prompt completion of its ongoing evaluation of  methylmercury, FDA is unable to give direction to the industry on whether  it should establish HACCP controls for this hazard, thus potentially placing  consumers at risk of exposure to unsafe levels of methylmercury.  Furthermore, without FDA’s timely notification to industry when  deficiencies are observed, serious problems are not corrected promptly.  Finally, without baseline data, such as that provided by regular microbial  testing, FDA is unable to measure the HACCP program’s effectiveness and  is unable to identify when and where corrective actions are needed.
Concerning imports, FDA does not have seafood equivalence or  compliance agreements with any foreign country, which is one of the most  effective methods for ensuring the safety of imports. Lacking such  agreements, FDA must rely, in part, on a review of importers’ records to  ascertain that imported products are processed under an acceptable  HACCP system. However, most importers have not had the required  documentation to demonstrate that the product offered for entry has been  processed under HACCP controls. In addition, by not communicating the  results of foreign firms’ inspections to U.S. port of entry personnel, the  likelihood that unsafe products from these firms are not inspected prior to  their release into the U.S. market is increased. Finally, port of entry  inspections are insufficient to ensure the safety of imported seafood, are an  inefficient use of resources, and have been unable to keep pace with  increasing import shipments.

	Matters for Congressional Consideration

To strengthen FDA’s ability to ensure that all domestic seafood products  are processed under HACCP requirements, the Congress should provide  FDA with comprehensive authority to require the registration of all  seafood-processing firms.
To strengthen FDA’s ability to ensure the safety of imported seafood, the  Congress should amend the Federal Food Drug and Cosmetic Act to  require FDA to certify that seafood eligible for importation into the United  States is produced under equivalent food safety systems.

	Recommendations for Executive Action

To better ensure the safety of domestic and imported seafood consumed in  the United States, we recommend that the Commissioner of FDA   require that all seafood-processing firms, including vessels that meet  FDA’s HACCP criteria for land-based seafood firms, operate under  HACCP requirements;  conduct in-depth audits of seafood firms that operate HACCP systems  to verify that they identify and control all hazards reasonably likely to  occur;  emphasize to inspectors the need to revisit firms to observe the  processing of seafood product(s) selected for inspection as required by  FDA’s compliance manual and establish a system to monitor inspections  to ensure that such revisits occur;  develop milestones for completing the agency’s ongoing evaluation of  methylmercury and determine whether it is a seafood hazard reasonably  likely to occur; issue warning letters within FDA’s required time frames;  develop baseline information, such as regular microbial test results, and  use it to assess the effectiveness of HACCP systems over time;  develop specific goals and time frames for establishing equivalence  agreements while Congress considers whether to mandate FDA’s  certification of other countries’ equivalence before their seafood  products are allowed entry into the United States; and  communicate HACCP system deficiencies identified during FDA’s  importer inspections and foreign country inspections to port of entry  personnel so that potentially contaminated imported seafood is  examined before being allowed tothe United States.

	Agency Comments and Our Evaluation

We provided FDA with a draft of this report for review and comment. FDA  stated that it had made significant improvements in the regulation of the  seafood industry through the establishment of the HACCP system, but  recognized that areas need to be strengthened. FDA said it plans to or has  begun actions to address these areas. Regarding the eight specific  recommendations we made to FDA, the agency generally concurred with  six and disagreed with two. FDA also raised some concerns about  inferences that could be drawn from the report. For example, FDA said that  our draft report implied that seafood was, on the whole, riskier than other  commercial sources of animal protein because of the way we presented  foodborne illness outbreak data for seafood in comparison to data for meat  and poultry. FDA said that, according to CDC, outbreak data should not be  used to determine whether seafood is more or less dangerous than other  foods. We modified our report to include the actual number of cases  associated with seafood and meat and poultry outbreaks. We also added  CDC’s observation that diagnosable illnesses, such as scombroid poisoning  from seafood, are more easily recognized than illnesses from nonspecific  gastrointestinal symptoms caused by other foods. (See app. IV for FDA’s  written comments and our response. FDA also provided technical  comments, which we incorporated into the report as appropriate.)
FDA generally concurred that it should (1) verify that HACCP systems  identify and control all hazards reasonably likely to occur; (2) emphasize to  inspectors the need to revisit firms to observe actual product processing  and establish a system to ensure that those visits occur; (3) develop  milestones for completing its ongoing evaluation of methylmercury and  determining whether it is a hazard reasonably likely to occur; (4) issue  warning letters in a more timely manner; (5) develop baseline data, such as  testing for a specific hazard, to measure the effectiveness of its seafood  safety program; and (6) communicate HACCP system deficiencies  identified during FDA importer inspections and foreign country inspections  to port of entry personnel.
FDA did not concur with our recommendation to require that all seafood- processing firms, including vessels, operate under HACCP requirements.  FDA said that the vast majority of vessels currently exempt from the  HACCP requirements conduct limited processing on board, making it  unlikely that they would introduce significant food safety hazards that need  to be controlled. While FDA’s comments provide additional information on  the agency’s position on this issue, we continue to believe that our  recommended action is warranted. Numerous fishing vessels handle high- risk products, such as tuna, which if not kept at appropriate temperatures,  can result in foodborne illness. Absent a comprehensive inventory of all  seafood-processing operations, including those on board vessels, FDA is  unable to ensure that the HACCP system for identifying and controlling  hazards is uniformly and consistently applied. If upon reviewing a vessel’s  operation, FDA determines that food safety hazards are not reasonably  likely to occur, FDA may decide that a HACCP plan is not required for that  vessel. Furthermore, seafood processors and vessels that are not exempted  from HACCP requirements are required to establish and implement a  written sanitation standard operating procedure. Therefore, bringing  vessels under the HACCP regulatory requirements would require them to  have written sanitation operating procedures, even if FDA determined they  do not need a HACCP plan.
FDA also did not concur with our recommendation that the agency develop  specific goals and time frames for establishing equivalence agreements  while Congress considers mandating the certification of other countries’  equivalence before their seafood products are allowed entry into the  United States. In commenting on this recommendation, FDA noted that  foreign equivalencies is one of its priorities for fiscal year 2001, but said  that a considerable exchange of data among the countries involved must  take place before equivalency determinations can be made. We continue to  believe, however, that this recommendation has merit for a variety of  reasons. First, without goals and time frames, there is little or no incentive  to complete equivalence agreements. For example, FDA and the Canadian  Food Inspection Agency have had discussions and have engaged in  activities aimed at determining equivalence of the two countries’ systems  for over 3-1/2 years, since Canada first requested such action in 1997.  Second, importers are responsible for ensuring that imported seafood  meets HACCP requirements either by importing from countries with an  equivalence agreement or by providing documentary support. However,  because FDA has no equivalence agreements, seafood importers must use  the more difficult and costly alternative of providing documentary support.  Finally, it is generally recognized that establishing equivalence agreements  with countries that have comparable safety and sanitation systems is the  most effective way to ensure the safety of imported food. Equivalence  agreements will help FDA reduce its reliance on importer and port of entry  inspections and enable it to leverage its staff resources by sharing the  responsibility for seafood safety with the exporting countries. Establishing  goals and time frames will help FDA measure its progress toward obtaining  such agreements and assist Congress in determining when to mandate that  FDA certify an exporting countries equivalence, if Congress decides to do  so.
We conducted our review from February through December 2000 in  accordance with generally accepted government auditing standards.
As agreed with your offices, unless you publicly announce its contents  earlier, we plan no further distribution of this report until 30 days from the  date of this letter. At that time, we will send copies to congressional  committees with jurisdiction over food safety issues; the Embassies of  Canada and Chile; the Secretary of Agriculture; the Secretary of Health and  Human Services; the Director, Office of Management and Budget; and other  interested parties. We will make copies available to others on request.
If you have any questions about this report, please contact me at (202) 512- 3841. Major contributors to this report are listed in appendix V.

Scope and Methodology

As you requested, we evaluated the Food and Drug Administration’s (FDA)  system to better control the risk of foodborne illness resulting from unsafe  domestic and imported seafood. As agreed with your office, we excluded  molluscan shellfish (mussels, clams, oysters, and roe-on scallops) from this  review because those products are regulated under a different regulatory  structure. A separate GAO report will address federal efforts to ensure the  safety of those products.
To obtain FDA’s views on its program for domestic and imported seafood,  we interviewed cognizant government and industry officials. Specifically,  we interviewed officials and/or reviewed documents from FDA’s Center for  Food Safety and Applied Nutrition, Office of Seafood; Office of Regulatory  Affairs; Office of Enforcement, Division of Compliance Policy; and Division  of Import Operations and Policy. To obtain industry’s views on the Hazard  Analysis and Critical Control Point (HACCP) system for seafood and FDA’s  oversight of seafood firms, we also met with the National Fisheries  Institute—a seafood trade association whose membership includes  domestic and international firms. To learn about other HACCP regulatory  systems, we interviewed U.S. Department of Agriculture (USDA) officials  to discuss their implementation of a HACCP system for meat and poultry  and the performance data requirements associated with that program.
To assess FDA’s system for ensuring the safety of domestic seafood, we  visited three of the FDA districts where large volumes of seafood are  processed—Florida, New England, and Seattle—and met with officials to  discuss relevant regulations, policies, and procedures. We also visited  seafood firms to observe FDA’s seafood inspections first-hand and met with  seafood industry personnel in the three districts, including officials and  members of the National Food Processors Association. We also  participated in the HACCP training course on seafood offered by the  Seafood HACCP Alliance.
We analyzed 97 FDA inspections of domestic seafood products as recorded  on FDA’s Form 3501 for fiscal year 1999. They were randomly selected from  all 3501 forms in the three districts for fiscal year 1999. Table 3 shows our  sampling plan for the three districts. We also analyzed 227 seafood warning  letters issued nationwide during calendar years 1998 and 1999 and through  the first 4 months of calendar year 2000 to assess the time frames for  issuing warning letters and other pertinent information. Of these 227  warning letters, 162 were issued to domestic processors after inspections  conducted in fiscal year 1999. In recognition of FDA’s time frames that  allow 30 working days for FDA to process a warning letter, we did not  consider any warning letter that was issued within 45 calendar days after  the date of the inspection to have exceeded the issuance time frames.
Since we used a sample (called a “probability sample”) of 97 inspection  forms to develop our estimates of inspections in the three districts we  visited, each estimate has a measurable precision, or sampling error, that  may be expressed as a plus/minus figure. A sampling error indicates how  closely we can reproduce from a sample the results that we could obtain if  we were to take a complete count of the universe by using the same  measurement methods. By adding the sampling error to and subtracting it  from the estimate, we can develop upper and lower bounds for each  estimate. This range is called a “confidence interval.” Sampling errors and  confidence intervals are stated at a certain confidence level—in this case,  95 percent. For example, a confidence interval at the 95-percent confidence  level means that in 95 out of 100 instances, the sampling procedure we used  would produce a confidence interval containing the universe value that we  are estimating.
Table 4 shows sampling errors for selected estimates used in this report.  Because we report subsets of the 97 inspections, such as only the products  with HACCP plans, sampling errors are larger than they would be if we  reported estimates based on the entire 97 inspection reports. Sampling  errors range from 7 to 14 percent at the 95-percent confidence level.
Table 5 shows sampling errors for four subgroups used in table 4.
We also visited two of the leading seafood exporters to the United States— Canada and Chile—to (1) obtain an understanding of their rules and  regulations, (2) compare those countries’ seafood safety programs with the  U.S. program, and (3) observe how those countries implement their safety  rules and regulations for seafood.
To assess FDA’s system for imported seafood, we (1) examined the status  of FDA’s equivalence determinations with leading exporters of seafood to  the United States and (2) reviewed and compared USDA and FDA  authorities regarding equivalence determinations. We also analyzed FDA’s  foreign country seafood inspection reports for fiscal year 1999 for the four  countries visited—Ecuador, Vietnam, Taiwan, and the Philippines. We  compared FDA’s findings during those foreign inspections with FDA’s  actions at U.S. ports of entry. We also obtained and analyzed all of FDA’s  records of importers’ inspections for fiscal year 1999 (3502 forms) and  verified with FDA officials that FDA inspectors were adequately trained  and did not encounter difficulties when completing these forms. Finally, we  compared and contrasted selected aspects of FDA’s HACCP system for  seafood with those of Canada and Chile.
We conducted our review from February through December 2000 in  accordance with generally accepted government auditing standards.

Seafood-Related Illnesses

Seafood-related microbiological, chemical, and physical hazards can cause  illnesses. According to the Centers for Disease Control and Prevention's  (CDC) data, in 1997, the leading causes of seafood-related outbreaks were  two natural toxins—ciguatoxin (42 percent of all outbreaks) and  scombrotoxin (46 percent of all outbreaks). Table 6 summarizes some  seafood-related hazards and the illnesses they cause.

Seafood Safety Programs in the United States, Canada, and Chile

The United States, Canada, and Chile have adopted HACCP-based seafood  inspection programs to ensure the safety of their seafood products. As  summarized in table 7, the programs differ in several ways.
The following sections discuss the inspection programs of Canada and  Chile only.

	Canada’s Seafood Safety Program

To ensure the safety of its domestic seafood, Canadian officials said that in  1992, Canada adopted a HACCP-based system that encompasses safety and  quality. In 1996, the Canadian Food Inspection Agency and industry formed  a task force to further study and improve the system. The resulting Quality  Management Program (QMP) requires that all seafood companies develop,  maintain, and implement comprehensive quality and safety plans. Seafood  companies are required to register with the inspection agency, and each  processor’s QMP plan must include the following:  Management roles and responsibilities, which may include a written  description of each manager’s accountability or a written statement of  commitment signed by all management staff.
Product and process information that includes product descriptions and  processing steps.
A prerequisite plan that addresses facilities design; construction;  maintenance; and all potential sources of contamination, including  employee hygiene; and company recall procedures.
A regulatory action point plan that describes controls designed to  ensure that the products meet fish inspection regulations addressing  tainted, decomposed or unwholesome products, packaging materials  and ingredients, and labeling requirements.
A HACCP plan identifying and addressing any health and safety hazards  related to the product or process by applying the seven HACCP  principles.
Steps for verifying and maintaining the QMP plan.
The inspection agency reviews the QMP plans, including HACCP plans,  before they are put into effect by seafood firms. A written hazard analysis is  part of the required documentation. Once the plan is implemented, the  inspection agency conducts in-depth audits of the QMP’s implementation.
For imported seafood products, Canada adopted a two-tier regulatory  system. Importers that have a regular license can import seafood products  from any country but must notify the inspection agency within 48 hours of  the product’s entry. Depending on the product’s history, the inspection  agency decides whether to detain the product for visual examination  and/or testing. Inspection agency officials stated that, on average, they test  about 15 percent of all imported seafood in this category. Alternatively,  importers may voluntarily participate in the QMP for Importers. The  program allows seafood importers to develop their own system for  monitoring and evaluating products that they import while the inspection  agency conducts quarterly audits of participating companies to ensure  compliance with seafood safety standards. Importers must perform or have  performed product testing at a minimum frequency of 15 percent or as  otherwise established in Canadian agreements with other countries. The  inspection agency has also provided an incentive for importers to obtain  products from foreign companies that have a good history of compliance.  Under this arrangement, foreign seafood firms with a good compliance  record are considered for reduced inspection frequencies at an importer’s  request. If approved, they are incorporated in the “A” list. To be part of this  list, a foreign seafood firm must, at a minimum, have 10 acceptable  inspections from at least 30 imported lots of seafood. Firms on the “A” list  are subjected to unannounced inspections at predetermined frequencies.

	Chile’s Seafood Safety Program

In 1994, Chile implemented a HACCP-based inspection program for  seafood to improve the effectiveness of its seafood exporters’ certification  program and to respond to future requirements of Chile’s major export  markets—the European Union (Directive 91/493/CEE) and the United  States. The Chilean National Seafood Service (Servicio Nacional de Pesca,  Sernapesca) administers Chile’s seafood safety program. Chilean officials  said that the HACCP system in Chile is modeled after the U.S. National  Marine Fisheries Service System and Canadian systems. Therefore, it  incorporates sanitation, safety, and quality features. Seafood exporters,  including factory vessels, must be registered and authorized to export  through the certification program. It is illegal to operate without registering  with Sernapesca. In order to receive an export certification, exporters must  implement the HACCP requirements.
Sernapesca issued procedures manuals, technical norms, and inspection  instructions. Together, these documents instruct industry and inspectors  on how to review and validate HACCP plans, how to collect official  samples, and how to conduct objective inspections. Sernapesca must  review and approve HACCP plans. Seafood exporters are required to  maintain a written hazard analysis plan and to have it available for  inspection. Officials think it is important to know the reasoning for  inclusion or exclusion (in the HACCP plans) of hazards reasonably likely to  occur.
Sernapesca conducts monthly sanitation inspections of seafood exporters.  If the exporter fails the sanitation inspection, it is removed from  Sernapesca’s approved exporter list and thus can no longer receive export  certification. Vessels are inspected when they come into port—every 3  months on average. Seafood firms are instructed to conduct biweekly  verifications of their HACCP systems, and Sernapesca inspects firms once  every 2 to 3 months, depending on the product. After inspection, firms are  classified I through IV, depending on the number of deficiencies observed  by inspectors. These categories determine whether firms will continue to  be certified.

Comments From the Food and Drug Administration

The following are GAO’s comments on the Food and Drug Administration’s  letter dated January 17, 2001.

	GAO’s Comments

1. We modified our report to include the actual number of cases associated  with seafood and with meat and poultry outbreaks. We also added CDC’s  observation that reported illness outbreaks tend to be for illnesses more  likely to be recognized. According to CDC, diagnosable illnesses, such as  scombroid poisoning from seafood, are more easily recognized than  illnesses from nonspecific gastrointestinal symptoms caused by other  foods. 2. We believe that until FDA develops an inventory that identifies and  assesses each vessel’s on-board activities, FDA’s view that vessels not  performing functions beyond preparing the catch for holding pose little or  no risks lacks credibility. Numerous fishing vessels handle high-risk  products, such as tuna, which if not properly handled or held—kept at the  appropriate temperature—may result in foodborne illness. Furthermore,  although the number of vessels processing seafood on-board is unknown,  federal and state officials’ estimates lead us to conclude that a significant  number could be conducting on-board processing similar to that conducted  by land-based seafood firms. Land-based seafood firms that head,  eviscerate, and freeze products are required to comply with the HACCP  regulations. Exempting vessels from the HACCP regulations also  eliminates the requirement for a written standard operating procedure for  sanitation aimed at ensuring basic sanitation procedures and practices. We  modified the report to clarify the HACCP regulatory requirements for  vessels.
With respect to FDA’s comments on domestic firms found not to need  HACCP plans, we did not mean to suggest that all 1,055 of FDA’s  determinations exempting products from needing HACCP plans were  incorrect. We do question, however, whether FDA inspectors were justified  in exempting as many as 516 of these products on the grounds that storage  and repacking firms do not handle products presenting significant hazards.  In our view, many of these firms handle products with significant hazards  and should have HACCP plans. We did modify the report to include FDA’s  view that frozen products do not present significant food safety risks. 3. We agree that since the publication of our 1998 report, FDA has initiated  actions to improve controls over imported foods aimed at preventing  unscrupulous importers from bypassing or subverting port-of-entry  activities. However, the fact remains that without equivalence agreements,  FDA has to rely on labor-intensive inspections of products at the port of  entry as its primary line of defense against the entry of unsafe foods. We  continue to believe that port-of-entry inspections alone do not effectively  ensure the safety of imported seafood. Using port-of-entry inspections to  augment a program certifying that imported products are produced under  equivalent food safety systems is a much more efficient and effective way  to ensure the safety of imported foods. Providing FDA with authority  similar to that provided for the Food Safety and Inspection Service would  allow FDA to leverage its resources and provide greater assurance that  imported seafood is safe. Accordingly, we did not modify the report. 4. We agree with FDA’s comment that its efforts to gather and analyze  seafood firms’ compliance with HACCP requirements have merit but  continue to believe that compliance information alone is not a good  indicator of the seafood program’s impact on reducing contamination that  could cause foodborne illness. A performance-based measurement, such as  that used by USDA, would improve FDA’s evaluation of the effectiveness of  its programs for ensuring seafood safety. While there may not be any single  widespread hazard in seafood, scombrotoxin and ciguatoxin caused 46 and  42 percent of seafood illness outbreaks, respectively. Therefore, we  continue to believe that FDA should identify the hazards of most concern  (e.g., scombrotoxin), develop baseline information on such hazard(s), and  use that information to assess the effectiveness of its programs in reducing  the prevalence of such hazards. We modified the report to provide  additional information regarding FDA’s compliance-based data. 5. We continue to believe that an emphasis on equivalence agreements by  establishing goals and time frames is appropriate because equivalency is  generally a more effective way to ensure the safety of imported food.  Equivalence agreements will help FDA reduce its reliance on importer and  port-of-entry inspections and enable it to leverage its staff resources by  sharing the responsibility for seafood safety with the exporting countries.  Goals and time frames are standard management tools used to monitor the  progress of important initiatives, such as equivalence agreements. Without  them, there is less incentive to complete the initiatives. In this regard, FDA  and the Canadian Food Inspection Agency have had discussions and  engaged in activities aimed at determining the equivalence of the two  countries’ systems since Canada first requested such action in 1997.  Furthermore, without any equivalence agreements for seafood, importers  must use the more difficult and costly alternative of providing documentary  support that the exporting seafood processor has a HACCP system that  meets U.S. requirements. We also recommend that Congress consider  mandating that FDA certify other countries’ equivalence before their  seafood products are allowed entry into the United States. If Congress  decides to act in this regard, we would envision that Congress would  provide FDA a number of years to complete such determinations. By  establishing goals and time frames for equivalence agreements, FDA would  assist Congress in this effort. FDA could establish alternative provisions for  countries that export seafood to the United States and have systems that  are not equivalent, such as requiring them to provide laboratory tests or  other assurances that the seafood meets U.S. standards.
See comment 2.
See comment 5. 6. We commend FDA for taking action to add foreign firms to its import  alert list after we brought this issue to its attention. We modified the report  to include this information.

GAO Contacts and Staff Acknowledgments

	GAO Contacts

	Acknowledgments

In addition to those named above, Maria Cristina Gobin, Randolph D.  Jones, Leo Acosta, Roberto Pinero, Alicia Antonetti, Fran Featherston,  Carol Herrnstadt Shulman, and Oliver Easterwood made key contributions  to this report.

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Summary:
What GAO Found

Since the Food and Drug Administration (FDA) issued the Hazard Analysis and Critical Control Point system (HACCP) regulations for seafood, the food industry has made some progress in ensuring the safety of seafood. However, several important weaknesses compromise the overall effectiveness of the federal seafood safety system. If left uncorrected, they will continue to undermine the goal of HACCP systems--that is, controlling hazards in the production process before the product reaches the market. More importantly, U.S. consumers may remain at risk of contracting foodborne illness from contaminated domestic and imported seafood products.