Food Safety: FDA's Imported Seafood Safety Program Shows Some Progress, but Further Improvements Are Needed
Published: 2004-01-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: More than 80 percent of the seafood that Americans consume is imported. The Food and Drug Administration (FDA) is responsible for ensuring that imported seafood is safe and produced under sanitation and safety systems comparable to those of the United States. Since GAO reported in 2001 that FDA's seafood inspection program did not sufficiently protect consumers, additional concerns have arisen about imported seafood containing banned substances, such as certain antibiotics. In this review, GAO was asked to evaluate (1) FDA's progress in implementing the recommendations in the 2001 report and (2) other options to enhance FDA's oversight.
section_title: What GAO Found
paragraphs: Since GAO's January 2001 report, FDA's imported seafood safety program has shown some improvement. FDA inspects more foreign firms, and its inspections show that more U.S. seafood importers are complying with its requirements. FDA also slightly increased the number of seafood products it tests at U.S. ports of entry to just over 1 percent. However, FDA still has not established equivalence agreements with seafood exporting countries as GAO recommended in its 2001 report. Equivalence agreements that commit U.S. trading partners to maintain comparable food safety systems are an efficient way to ensure imported seafood safety. Unlike the U.S. Department of Agriculture, FDA is not legally required to certify that countries exporting food products to the United States have equivalent food safety systems. According to a panel of nationally recognized experts that GAO convened to address this and other issues, establishing these types of agreements would shift some of FDA's burden for ensuring seafood safety to foreign governments. This shift, in turn, would allow FDA to focus its limited resources on seafood products from countries with less advanced food safety systems. FDA also made little progress regarding the recommendation GAO made in 2001 that FDA communicate to U.S. port-of-entry personnel serious deficiencies identified during inspections so that potentially contaminated imported seafood is examined before it enters the United States. GAO found that FDA continues to experience long delays between finding deficiencies and taking action. For example, GAO's review of foreign firm inspection records found that it took an average of 348 days for FDA to alert port-ofentry personnel about serious safety problems identified at six foreign firms. Moreover, GAO found that FDA does not prioritize enforcement actions when violations that pose the most serious public health risk occur or have an automated system to track the time involved in documenting, reviewing, and processing enforcement actions. FDA officials acknowledged some of the problems that GAO identified regarding FDA's current imported seafood inspection program, but they also raised concerns about limited inspection resources and competing priorities, such as the recent need to implement provisions of the Bioterrorism Act of 2002. GAO identified several options that FDA could consider to augment its resources and enhance its current program, including (1) commissioning seafood inspectors from the National Oceanic and Atmospheric Administration's (NOAA) Seafood Inspection Program, (2) using state regulatory laboratories and/or private laboratories to augment FDA's testing of imported seafood, and (3) developing a program to use third-party inspectors to augment its program.

section_title: Letter
paragraphs: More than 80 percent of the seafood that Americans consume is imported  from an estimated 13,000 foreign suppliers in about 160 nations. If  contaminated, imported and domestic seafood can cause foodborne  illnesses, with problems ranging from mild gastrointestinal discomfort to  neurological damage. The Centers for Disease Control and Prevention  (CDC) estimates that contaminated seafood (finfish and crustaceans)  accounted for about 15 percent of the documented foodborne illness  outbreaks in the United States—a greater percentage than either meat or  poultry, even though meat and poultry are consumed at 8 and 6 times the  rate of seafood, respectively.
The Food and Drug Administration (FDA) is responsible for ensuring the  safety of domestic and imported seafood. It implements the Hazard  Analysis and Critical Control Point (HACCP) system—a science-based,  food safety program introduced for seafood in 1997. The HACCP system is  designed to improve food safety by having industry identify and control  biological, chemical, and physical hazards in products before they enter the  market. Under FDA’s food safety regulations, seafood-processing firms  must identify hazards that are reasonably likely to occur and must develop  and implement plans to control those hazards.
To ensure compliance with its food safety regulations, FDA requires that  importers meet one of two conditions. First, importers may obtain seafood  from countries that have entered into voluntary agreements with FDA.  These agreements may document that foreign countries’ seafood safety  systems are equivalent to or in compliance with that of the United States.  Second, if these agreements do not exist, importers must have records  demonstrating that foreign firms’ products offered for entry into the United  States have been processed in accordance with U.S. HACCP requirements.  Such records may include, for example, a copy of the foreign firms’ HACCP  plan. FDA inspects some U.S. importers and some foreign firms to  determine their compliance with HACCP regulations. It also examines and  tests selected samples of imported seafood products at U.S. ports of entry  to verify their safety. FDA has the authority to hold imported seafood  products while it determines if the product is adulterated. FDA also has  the authority to detain imported seafood products and require importers to  demonstrate that the products are not adulterated, a process called  detention without physical examination (DWPE).
The Department of Commerce also has a role in promoting seafood safety  and quality. The department has statutory authority for providing voluntary  inspection services to assist in marketing seafood products. These  inspection services are provided through its Seafood Inspection Program,  which is located in the National Oceanic and Atmospheric Administration  (NOAA). The Seafood Inspection Program provides fee-for-service safety,  sanitation, and/or product inspections for approximately 2,500 foreign and  domestic firms annually. Program services include inspections for safety,  wholesomeness, and proper handling as well as grading seafood,  laboratory analysis, training, and product inspection and certification. The  Seafood Inspection Program’s services affect 17 percent of the imported  and domestic seafood consumed in the United States.
In 2001, we reported that FDA’s oversight of domestic and imported  seafood provided insufficient assurance that the seafood is safe. With  regard to imported seafood, we found that FDA relied on reviews of  importers’ records, inspections of selected foreign firms, and product  examination and testing at the port of entry to ensure seafood safety—but  that FDA reviewed records or performed inspections for a very small  percentage of products. For example, FDA tested less than 1 percent of all  seafood products imported into the United States in fiscal year 1999.  To  better ensure the safety of imported seafood, we recommended that FDA  develop specific goals and time frames for establishing agreements with  other countries to document that their seafood safety systems are  equivalent to that of the United States. Without such equivalence  agreements, FDA must rely principally on its reviews of importers’ records  to ascertain that imported seafood products are processed under an  acceptable food safety system. Many importers did not have the required  documentation, and, when they did, the documentation often did not  adequately demonstrate compliance. We also recommended that FDA  communicate to agency personnel at U.S. ports of entry deficiencies  identified during its importer and foreign firm inspections because FDA  was not scrutinizing products from problem firms at these ports.
Since our 2001 report, questions have persisted about the effectiveness of  FDA’s seafood safety program and about the adequacy of the agency’s  inspection and laboratory resources. You asked us to (1) reevaluate FDA’s  program for ensuring the safety of imported seafood and determine the  status of FDA’s efforts to implement our recommendations and (2) explore  other options for enhancing FDA’s imported seafood inspection program,  such as using the inspection programs and laboratories of other entities.
In response to your request, we reexamined FDA’s program for ensuring  the safety of imported seafood, including the status of equivalence  agreements, inspections of importers and foreign firms, and product  examination and testing at ports of entry. To determine FDA’s progress in  establishing equivalence agreements with countries that export seafood to  the United States, we interviewed FDA officials who are responsible for  evaluating other countries’ food safety systems. To evaluate FDA’s actions  to enforce compliance with its food safety requirements, we analyzed  FDA’s records of inspections for a random sample of U.S. importers and for  all of the foreign firm inspections conducted in fiscal year 2002. To explore  other options for enhancing FDA’s current imported seafood inspection  program, we convened a panel of nationally recognized food safety experts.  The panel, selected with assistance from the National Academies,  discussed the effectiveness of FDA’s current approach for ensuring the  safety of imported seafood and provided advice on ways to strengthen it. In  addition, the panel (1) discussed several other options, such as using  NOAA’s Seafood Inspection Program and laboratories, as well as those of  other entities, to enhance FDA’s program and (2) deliberated the  advantages and disadvantages of the various options. Appendix I contains  additional details of our scope and methodology, and appendix II contains  a summer of the expert panel’s observations on the safety of imported  seafood.
subsections: section_title: Background
paragraphs: 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.  Seafood products represented about 15 percent, or 26, of the 169 foodborne  illness outbreaks from a confirmed source—a level greater than that  associated with meat or poultry products, which are consumed at 8 and 6  times the rate of seafood, respectively. However, as we reported in 2001,  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 that result from nonspecific gastrointestinal symptoms caused by  other foods. Moreover, the actual number of individual cases of illnesses  resulting from traced outbreaks were higher for meat and poultry (619 and  353 cases, respectively) compared with 108 cases for seafood. FDA stated  that seafood outbreaks may have involved fewer individual cases of illness  because seafood has much lower consumption rates than meat and poultry.  FDA also noted that some seafood-related illnesses may be caused by  recreational or subsistence fishing over which the federal government has  little or no control. The Center for Science in the Public Interest, a  consumer interest group that works on nutrition and food safety issues, has  used CDC data and other sources to track the number of reported food- poisoning outbreaks in the United States and estimates that seafood was  responsible for 18 percent of the outbreaks of foodborne illnesses that the  center tracked between 1990 and 2002.
Several types of hazards can cause seafood-related illnesses. Specifically:   Biological hazards—include pathogens, such as Clostridium  botulinum, Listeria monocytogenes, Salmonella species, and  Staphylococcus aureus, and parasites such as roundworms and  tapeworms.
Chemical hazards—include compounds such as methylmercury, which  can cause illness from long-term exposure; residues from drugs  unapproved for use in food animals, such as chloramphenicol and  nitrofurans, or overuse of approved drugs that are sometimes used in  aquaculture production, which may be carcinogenic, allergenic, and/or  cause antibiotic resistance in humans; and marine toxins. According to  FDA officials, two marine toxins with potentially serious health  effects—scombrotoxin and ciguatoxin—cause most of the reported  seafood-related illnesses, including gastrointestinal and neurological  problems. These toxins are heat resistant and cannot be inactivated by  cooking.
Physical hazards—include foreign objects in food that can cause harm  when eaten, such as glass or metal fragments.
Figure 1 shows the steady growth in U.S. consumption and imports of  seafood between 1993 and 2002. According to data from the NOAA’s  National Marine Fisheries Service, the United States imported about 4.2  billion pounds, or more than 80 percent, of its seafood in 2002, as shown in  the figure.
In addition, U.S. seafood consumption rose about 25 percent between 1980  and 2002, from 12.5 pounds per person to 15.6 pounds per person. Most  seafood consumed in the United States is imported from an estimated 160  countries and 13,000 foreign processors. In 2002, the top 6 seafood  exporting countries—Canada, China, Thailand, Chile, Ecuador, and  Vietnam—accounted for approximately 63 percent of imported seafood.  Imported products include fresh and frozen tuna and salmon as well as  crustaceans, such as shrimp and lobsters. Figure 2 shows the proportion of  imports to the United States from the 6 leading exporting countries.
A large and rapidly growing proportion of worldwide seafood production,  including U.S. imports, is produced by aquaculture. In 2000, aquaculture  represented about 27 percent of global seafood production, and has  increased by an average of 9.2 percent annually since 1970, compared with  only an average 1.4 percent increase for captured seafood, according to the  Food and Agriculture Organization of the United Nations. As in other  animal production systems, aquaculture producers may use antibiotics and  other chemicals to prevent or treat disease. Some producers have been  found to misuse approved drugs or to use unapproved drugs or chemicals  that pose potential human health hazards, such as antibiotic resistance,  allergic reactions, or cancer. In recent years, food safety authorities in  Europe, Canada, and the United States have begun to detect these  substances and are taking steps to control their illegal use.
FDA is responsible for ensuring the safety of both domestic and imported  seafood under the Federal Food, Drug, and Cosmetic Act. In 1997,  following recommendations by the National Academy of Sciences and  others, FDA adopted a program of preventative controls that are designed  to identify hazards during 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 (CCP) to prevent and reduce  contamination. The HACCP system is based on the following seven  principles that each seafood firm must address:   Conduct a hazard analysis. Identify hazards that are reasonably likely  to occur.
Identify the CCP. Identify a point, step, or procedure in the production  process where controls can be applied to prevent, eliminate, or reduce  to an acceptable level a food safety hazard that is reasonably likely to  occur.
Establish critical limits for each CCP. Set the maximum or minimum  value at which parameters, such as cooking time and temperature, 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—that is,  ensuring the production of safe products.
Establish record-keeping and documentation procedures. Maintain  documentation, including the HACCP plan; CCP monitoring; corrective  actions; and verification activities.
Under the HACCP regulations, seafood-processing firms are responsible  for conducting a hazard analysis and for developing and implementing  HACCP plans for hazards that are determined to be reasonably likely to  occur. These hazards may include marine toxins, microbiological  contamination, chemical contamination, pesticides, drug residues,  decomposition in certain species, parasites, the unapproved use of food or  color additives, and physical hazards. For each hazard identified, the firms  must establish CCPs to prevent or reduce contamination. Firms also must  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.
As we reported in 2001, FDA has four approaches to verify compliance with  HACCP regulations and ensure the safety of imported seafood. FDA has the  authority to enter into voluntary agreements with individual countries on  the basis of a determination of equivalence of their seafood safety systems  with U.S. HACCP requirements. First, under the provisions of the World  Trade Organization Agreement on the Application of Sanitary and  Phytosanitary Measures, to which the United States is a signatory, FDA is  obligated to enter into consultations with the aim of achieving equivalence  agreements upon the request of other World Trade Organization member  nations. FDA considers other systems to be equivalent when it finds one  or more of an exporting country’s food safety measures—such as laws,  regulations, guidance, and procedures—to be equivalent to our own. U.S.  importers can demonstrate HACCP compliance by acquiring seafood from  countries with these agreements. Second, in the absence of such  agreements, importers are responsible for demonstrating, through  documentation, that the seafood they import into the United States is  produced under systems that are compliant with U.S. HACCP  requirements. During its periodic inspections, FDA reviews this  documentation to determine whether importers have met their  responsibilities under the HACCP regulations. Third, FDA also inspects a  limited number of foreign seafood firms to determine the firms’ compliance  with HACCP. Lastly, FDA selects a small number of individual shipments at  U.S. ports of entry to conduct visual examinations and/or collect and test  samples to determine if the seafood is misbranded or adulterated. FDA  commented that detaining suspect imported seafood for physical or  laboratory examination by the importer is also part of its import control  strategy.
If FDA observes HACCP violations during its inspections and testing, it can  take several regulatory actions. For example, FDA issues warning letters in  cases where violations raise safety concerns that may lead to enforcement  action, such as detention, seizure, or injunction—which is a court order to  refrain from distributing a product. In the case of foreign firms, a warning  letter could advise them of a forthcoming detention, the only enforcement  action that is available. Firms that receive warning letters are asked to  respond to FDA in writing to indicate what actions they will take to correct  the identified problems.
To fund FDA’s food safety programs, Congress provided $393 million for  fiscal year 2002. This amount represents a $106 million increase over FDA’s  budget for fiscal year 2001, including a $93 million supplemental  appropriation for counterterrorism activities, including those in the  Bioterrorism Act of 2002. FDA used some of this increase to enhance its  coverage of imported foods, including hiring over 600 new food safety  investigators and laboratory personnel; increasing the number of port-of- entry examinations and laboratory testing; and conducting foreign  inspections that focused on high-risk foods, including seafood.
section_title: FDA’s Imported Seafood Safety Program Shows Some Improvement, but Deficiencies Persist
paragraphs: Since our January 2001 report, FDA has made improvements to three of the  four approaches it uses for ensuring the safety of imported seafood— importer inspections, foreign inspections, and port-of-entry inspections.  FDA has not implemented either of the recommendations we made in our  2001 report regarding establishing equivalence agreements with exporting  countries or communicating deficiencies found during inspections to FDA’s  port-of-entry personnel. Additionally, FDA continues to experience long  delays in issuing warning letters or detaining imported seafood at U.S.  ports of entry after investigators find serious deficiencies. By not taking  timely regulatory action, FDA increases the likelihood that unsafe seafood  will enter the U.S. market.
subsections: section_title: FDA’s Program Shows Some Improvement Since Our Last Report
paragraphs: We found that FDA has made some progress in strengthening the efficacy  of three approaches for ensuring the safety of imported seafood.  However, the agency has made no progress regarding the development of  equivalence agreements with seafood exporting countries. Figure 3  summarizes the changes that have taken place in FDA’s seafood safety  program.
As we reported in 2001, in the absence of equivalence agreements, U.S.  seafood importers are required to maintain written product specifications  and take at least one of six affirmative steps to document foreign firms’  compliance with U.S. requirements. Figure 4 shows the regulatory  requirements for importers and the documentation that importers can use  to demonstrate compliance.
While importers have made some progress in maintaining the required  documentation, they are still far from full compliance, according to our  analysis of FDA’s inspection forms for fiscal year 2002. Specifically, on the  basis of our random sample of inspections, we estimate that importers had  the required documentation for 48 percent of the products they imported,  which is up from the 27 percent noted in our 2001 review. That is, an  estimated 48 percent of imported seafood products listed in the FDA  inspection forms contained (1) a written product specification document  and (2) documentation for at least one of the six possible affirmative steps  required by the regulations. In fiscal year 2002, FDA inspected fewer  domestic importers—402 (of an estimated 8,500) compared with 644 that  the agency reports it inspected in fiscal year 1999. Our analysis shows that  FDA investigators made some errors when documenting these 2002  inspections. On the basis of our survey, we estimated that in about 4  percent of the inspection forms, FDA investigators erroneously indicated  that the exporting country had an equivalence agreement in place for  seafood. Therefore, they did not require the importer to produce the  additional documentation required in the absence of an equivalence  agreement (written product specifications and at least one affirmative  step). FDA officials said the oversight occurred because the investigators  had correctly determined that the importers received products from firms  on a list of preferred providers developed by the Canadian Food Inspection  Agency (CFIA), but the investigators erred in assuming that having the  preferred provider list meant that Canada has an equivalence agreement  with the United States. FDA officials said they will take steps to clarify the  requirement with field personnel to avoid confusion in the future.
FDA also increased the number of foreign countries visited and seafood  firms inspected since we last reported in 2001. FDA visited 13 of an  estimated 160 countries in fiscal year 2002 to provide education on the U.S.  HACCP requirements and to inspect 108 of about 13,000 seafood firms  compared with 4 countries and 37 firms inspected in fiscal year 1999. FDA  selects the countries for inspection on the basis of previous compliance  problems, the volume of seafood exported to the United States, and the  type of product and associated risk. Once it selects a country, FDA selects  foreign firms that have a problematic compliance history and works with  the country’s inspection authority to identify other firms for inspection.  According to the Director, FDA’s Office of Seafood, FDA plans to inspect  about 100 seafood firms in 10 or more foreign countries annually in the  future. Although this number represents fewer firms and countries than  FDA inspected in 2002, it represents more than FDA inspected in fiscal year  1999. These inspections tend to be targeted on developing countries that  are major exporters to the United States.
FDA officials also said they have begun to increase laboratory testing of  imported seafood, in particular for aquaculture drug residues, as a result of  the increase in staff resources the agency received from the Bioterrorism  Act of 2002. According to these officials, in fiscal year 2002, FDA had 310  full-time-equivalent positions for inspections and laboratory testing of all  food, with 70 allocated for imported seafood; by fiscal year 2004, FDA  estimates that it will have 681 positions, with at least 103 allocated for  imported seafood. Furthermore, the proportion of foreign seafood  products detained for laboratory testing increased slightly, from less than  1.0 percent in fiscal year 1999 to about 1.2 percent in fiscal year 2002, while  imported seafood products increased by 13 percent (from 3.7 to 4.4 billion  pounds) over the same period. FDA officials expect laboratory testing to  increase to about 1.4 percent of imported seafood products in fiscal year  2004, after the newly hired investigators and laboratory personnel are fully  trained.
section_title: FDA Still Lacks Equivalence or Other Agreements with Seafood Exporting Countries
paragraphs: Although FDA stated in January 2001 that it planned to make progress  toward accomplishing foreign equivalence assessments and had listed this  goal as one of its priorities, the agency has not made progress in this  regard. As a result, FDA still has no equivalence or other agreements with  any seafood exporting country. At the time of our 2001 report, FDA had not  established any equivalence agreements with countries that export seafood  to the United States. However, the agency was discussing equivalence  agreements with Australia, Canada, and New Zealand and a compliance  agreement with Japan. To expedite development of these agreements, we  recommended that FDA develop specific goals and time frames for  completing them. FDA did not agree with this recommendation, but it  stated that accomplishing foreign equivalence assessments would be one of  its priorities for fiscal year 2001.
FDA officials now state that developing these agreements is no longer a  priority because of several factors. First, they point out that equivalence  agreements, as such, do not necessarily contribute to the enhanced safety  of imported seafood. Foreign producers are already required to produce  seafood products under a HACCP-based system that provides for a high  level of assurance of safety, and therefore, an FDA finding of equivalence of  a foreign seafood regulatory program or individual seafood safety  measures would be unlikely to substantially improve the safety of imported  seafood. Second, FDA officials said that the United States does not require  a finding of equivalence as a condition for exporting seafood to the United  States. Third, the procedures and criteria that are necessary to conduct  equivalence assessments have only recently been agreed upon at the  international level by the Codex Alimentarius Commission. FDA is  working with other U.S. agencies in considering how best to incorporate  these international guidelines in situations where equivalence assessments  might be helpful for either public health protection or trade facilitation.  The Office of the U.S. Trade Representative (USTR), the cabinet agency  responsible for developing and coordinating U.S. international trade policy,  generally agreed with this view and also said that even with equivalence  agreements, FDA would still be required to conduct compliance reviews  and audits in these countries. Finally, both FDA and USTR said the time  and resources required to develop equivalence agreements for seafood may  outweigh the benefits.
We agree that establishing equivalence agreements would not  automatically result in improved seafood safety. However, by establishing  agreements with countries that are able to demonstrate that their safety  systems are comparable to ours, FDA could free inspection resources and  allow more extensive examination of seafood products from countries with  less advanced systems. Because FDA does not have equivalence  agreements with countries that are exporters of seafood to the United  States, FDA principally relies on a review of documentation at importers’  offices to attempt to determine whether importers have met their  responsibilities and requirements under the seafood HACCP regulations.  As we previously discussed in this report, FDA reported inspecting only  about 8 percent of domestic importers in fiscal year 2003.
Our panel of experts also concluded that equivalence agreements or less  comprehensive alternatives represent an effective approach for ensuring  the safety of imported seafood and would also shift some of the burden for  ensuring that imported seafood meets U.S. HACCP requirements to  exporting countries. Furthermore, the panel suggested that FDA  concentrate its efforts on first developing agreements with countries  known to have high-quality food safety systems, thereby allowing FDA to  focus its limited inspection resources on countries known to have lesser  quality food safety systems.
We also acknowledge that time and resources are a necessary factor in  negotiating such agreements. However, we note that FDA has entered into  similar agreements with several countries that export fresh and frozen  shellfish products (fresh and frozen oysters, clams, mussels, and whole or  roe-on scallops) to the United States. By reaching agreements through  individual memorandums of understanding with Canada, Chile, Mexico,  New Zealand, and South Korea, FDA acknowledged that the foreign  countries’ shellfish sanitation programs meet U.S. standards. If it chose to  do so, FDA could enter into these types of agreements with countries that  export seafood products to the United States as well.
We also note that CFIA has established 14 agreements with foreign  exporting countries, including agreements for seafood products. According  to CFIA officials, these agreements allow CFIA to decrease the rate of  inspection for products from participating countries and direct its  resources to higher risk products from countries without such agreements.  In addition, CFIA believes that such agreements provide a vehicle for  increased communication, thereby allowing the exporting nation to take  corrective actions at violating firms discovered during CFIA’s verification  inspections.
section_title: Most FDA Regulatory Actions Are Not Timely
paragraphs: To ensure that FDA takes prompt regulatory action when its investigators  find food safety violations during importer and foreign firm visits, we  recommended in our 2001 report that FDA communicate deficiencies to  port-of-entry personnel so that they can examine potentially contaminated  imported seafood before it can enter the United States. Although FDA  agreed with this recommendation, we found that it continues to experience  long delays between finding deficiencies and taking action, such as issuing  a warning letter or detaining a product. As a result, potentially  contaminated seafood could be entering the U.S. market.
Once FDA investigators complete an inspection of U.S. importer’s  documentation or of a foreign firm’s processing plant, they submit a  recommendation and/or report to headquarters, which decides on  regulatory action. As explained below, FDA issues either untitled letters  or warning letters to inform responsible officials of violations found  during the inspection and to afford the officials the opportunity to  voluntarily take appropriate and prompt corrective action prior to the  initiation of enforcement action. The use of these letters is based on the  expectation that a majority of inspected firms will voluntarily comply.
FDA issues untitled letters when the documented violations do not meet  the criteria for detention. Untitled letters may address, for example, the  foreign company’s failure to have its HACCP plan list sulfites, an allergen;  failure to monitor the safety of water; or failure to maintain the cleanliness  of food contact surfaces. These letters do not set time frames for taking  corrective action and do not require a response from the firm.
FDA also issues warning letters when it finds violations that can directly  affect product safety, such as no controls for scrombrotoxin, which is a  toxin most commonly found in tuna, mahi-mahi, and bluefish that can  cause severe allergic reactions and diarrhea. These letters could lead to  enforcement action, such as product detention, if the company does not  promptly and adequately correct the problem. To ensure prompt and  adequate correction, FDA requires that warning letters be issued within 30  work days—approximately 45 calendar days.
However, FDA is not required to issue letters to firms prior to taking  enforcement action. The agency has the authority to take immediate  enforcement action, such as detaining a firm’s products. Under section  801(a) of the Federal Food, Drug, and Cosmetic Act, FDA can refuse  admission of imported products on the basis of information that the  product “appears” to be in violation of food safety requirements. When the  violations remain uncorrected despite prior warnings, FDA headquarters  notifies field offices by listing the firm and product on an Import Alert,  ordinarily the next course of action. According to FDA officials, now that  the requirements of seafood HACCP are well established, the agency  intends to use its refusal authority as the lead action without prior warning  to prevent the products of problem foreign processors from entering the  country. Our analysis of foreign firm inspections shows that the agency  used this authority for one firm in fiscal year 2002.
According to our review of inspection records for 99 of 108 foreign firms  that the agency visited in fiscal year 2002, FDA is encountering significant  delays in issuing warning letters when serious violations are identified.  During its inspections, FDA found that of these 99 foreign firms, 40 had  serious violations that warranted regulatory action. For 20 of these 40  firms, FDA decided to issue a warning letter. However, FDA took an  average of 157 calendar days to issue these warning letters. As shown in  figure 5, all 20 warning letters exceeded FDA’s time frame requirement of  approximately 45 calendar days.
Fourteen of these 20 warning letters were issued to firms producing high- risk products—such as semipreserved fish products, including smoked,  salted, and fermented fish that are susceptible to the growth of bacteria,  including Clostridium botulinum. This bacteria produces a toxin that can  cause gastroentiritis, vertigo, and respiratory failure. For the other 20 firms  that did not receive warning letters, FDA issued untitled letters to 14 firms  and is considering what action to take for the remaining 6 firms. Appendix  III provides a more detailed analysis of FDA’s foreign firm inspections in  fiscal year 2002.
In addition to failing to issue warning letters in a timely manner, FDA  encountered significant delays in alerting port-of-entry personnel to detain  imported seafood shipments from firms identified with serious safety  problems. On average, the agency took 348 calendar days to alert port-of- entry personnel about such products coming from 6 of the 99 foreign firms  that the agency inspected in fiscal year 2002. Moreover, 4 of the 6 firms  involved were processing high-risk products, which should have caused  FDA to take more prompt enforcement action. By not taking timely  enforcement actions and communicating these actions to U.S. port-of-entry  personnel, FDA increases the likelihood that unsafe products will enter the  U.S. market.
Similar delays occurred when FDA investigators found problems with U.S.  importers’ records. For the 96 inspection forms we reviewed, FDA found  that 16 importers had serious violations, such as failure to have the  required documentation. The agency issued warning letters to 8 of these  importers. The average time elapsed between the date of the inspection  and issuance of the warning letter was 103 calendar days; only 2 letters  were issued within the required 45 calendar days. Furthermore, 5 of the  warning letters covered high-risk products, including scombrotoxin- susceptible seafood, which, if not properly handled, could cause serious  health problems requiring hospitalization, particularly for elderly  individuals.
FDA officials acknowledged that these delays are excessive and  unacceptable and attributed them to a change in personnel responsible for  reviewing and issuing these letters. In addition, these officials stated that  the time frames were exceeded because the agency has been compelled to  give precedence to other public health concerns, such as developing  programs to protect the food supply against terrorist threats. Finally, we  found that FDA does not prioritize enforcement actions when violations  that pose the most serious public health risk occur or have an automated  system for tracking the time involved in documenting, reviewing, and  processing enforcement actions. As a result of increased funding, FDA  recently increased the number of personnel responsible for reviewing and  issuing these letters and expects to substantially increase its timeliness.  Additionally, FDA is in the early stages of developing an automated system  that will track the time involved in documenting, reviewing, and processing  enforcement actions.
section_title: Options Are Available for Enhancing FDA’s Imported Seafood Safety Program, but They Present Challenges
paragraphs: Several options could help FDA overcome some of the problems we  identified with its current regulatory approach for ensuring the safety of  imported seafood. These options could also help to augment FDA’s  inspections of foreign seafood firms, port-of-entry product examinations,  and testing of imported seafood. However, each option presents certain  challenges that FDA would need to address. First, NOAA could provide  staff from its Seafood Inspection Program to augment FDA’s inspections  capabilities, and FDA is considering the advantages and disadvantages of  doing so. However, some FDA officials are concerned about the cost of  using NOAA and about a perceived conflict of interest because NOAA’s  inspections are fee-for-service. Second, FDA could contract with state  regulatory laboratories to augment its current capacity to analyze imported  seafood samples, but our expert panel and FDA officials said that most  state laboratories might not have excess capacity to assist FDA. Third, FDA  could use private laboratories to assist in screening seafood samples,  provided that FDA first attests to the laboratories’ capabilities to perform  the work. Finally, if it has the authority, FDA could use third-party  inspectors to conduct HACCP inspections of foreign processing firms and  domestic importers; however, FDA would need to certify the inspectors’  competency. FDA has not undertaken a comprehensive review of its legal  authorities in this area.
subsections: section_title: NOAA’s Seafood Inspection Personnel and Laboratories Could Augment FDA’s Regulatory Program
paragraphs: NOAA officials said that they could assist FDA by providing various  services to augment FDA’s regulatory program for imported seafood. These  services include  HACCP training,  port-of-entry inspection and product sampling, and  assistance in developing and verifying equivalence or other types of  agreements with seafood exporting countries.
NOAA officials also said that they could conduct some domestic seafood  inspection services that FDA currently conducts, which would allow FDA  to refocus some of its resources on imported seafood. For example, NOAA  inspectors could certify domestic seafood products shipped to the  European Union and other countries, which is a service that NOAA  provided in the past on a fee-for-service basis. Also, FDA and NOAA could  agree to recognize NOAA’s current inspections of approximately 240  domestic processing firms and authorize NOAA to inspect other domestic  firms for compliance with HACCP. NOAA officials estimate that they could  provide FDA with up to 22 full-time-equivalent field inspectors as well as  additional technical support staff in its headquarters office.
In addition, NOAA and FDA officials are now negotiating the terms of an  agreement to use two NOAA laboratories to screen imported shrimp  samples for the antibiotic chloramphenicol. FDA is taking this action to  increase its testing capacity in response to the detection of the drug in  imported shrimp by food safety authorities in Europe, Canada, and some  U.S. states. Chloramphenicol is banned for use in food-producing animals  because there is no known safe level for human ingestion of this substance.  If the negotiations succeed, FDA would increase its screening capacity by  400 samples per year.
FDA recognizes that it has the authority to use NOAA and is considering  the advantages and disadvantages of doing so. While one official raised  concerns about a public perception of potential conflicts of interest  because NOAA inspections are fee-for-service, others said that this  potential problem could be addressed in an agreement between the two  agencies. Additionally, NOAA officials said that this concern could be  alleviated, in whole or in part, through its receipt of direct appropriations  to conduct these activities and/or through contracts with FDA that use  appropriated funds. Also, FDA-sponsored inspector training and periodic  audits of NOAA activities could further address such perceptions. FDA  officials also pointed out that it would have to incur costs to provide  training to NOAA inspectors and would have to develop an agreement with  NOAA specifying how NOAA would conduct inspections and investigations  on FDA’s behalf. We agree that FDA would need to incur additional costs to  use NOAA inspectors and laboratories, but these costs may be less than  those FDA would incur if the agency were to hire and train investigators  and laboratory analysts without prior seafood experience.
section_title: State Regulatory Laboratories Have the Capability, but May Not Have the Capacity, to Assist FDA
paragraphs: FDA is testing only a small fraction of the seafood entering the United  States, about 1.2 percent in fiscal year 2002. Our panelists and past GAO  reports have stated that port-of-entry laboratory testing is an ineffective  “overall” approach for ensuring the safety of imported seafood.  Nevertheless, our panelists believed that increased testing is desirable as  one approach for verifying the presence of biological, chemical, or drug  residues. Therefore, they stated that using state regulatory laboratories to  augment FDA’s seafood testing, such as state Departments of Health or  Agriculture, would be beneficial because  state laboratories are well equipped for food testing and provide reliable   these laboratories have procedures in place that could meet FDA’s  standards for compliance testing, and  FDA’s use of state laboratories could improve coordination and  information exchange regarding seafood-testing results between state  laboratories and FDA.
However, the panelists noted a disadvantage to using state regulatory  laboratories. Many states are financially constrained and therefore may not  have the excess capacity, equipment, time, or qualified analysts to assist  FDA. Furthermore, if FDA were to consider using state laboratories to  assist with port-of-entry testing, it would have to ensure that all  laboratories are using appropriate sampling and testing methodology.
While FDA laboratory officials agreed that using state regulatory  laboratories could be beneficial, they expressed some concerns regarding  using the laboratories to support FDA regulatory action. FDA officials  agreed that state regulatory laboratories are likely to have established  chain-of-custody procedures—that is, state laboratories control the sample  from the time they receive it through the sample analysis so that the sample  is not inappropriately altered. Additionally, FDA officials said state  laboratories would be required to meet all FDA analysis and data  requirements. However, using these laboratories may be a costly  alternative because FDA would have to provide training and oversight in  addition to the cost required to conduct the analyses. Furthermore, FDA  officials noted that states may not have excess capacity to assist FDA.
Despite these concerns, FDA is considering a pilot program with Florida to  determine how it could use state laboratory results. This pilot program is  similar to FDA’s proposed agreement with NOAA for testing imported  shrimp for the drug chloramphenicol. Under the proposed pilot program  with Florida, FDA would collect the samples and the state laboratory  would screen them for traces of chloramphenicol residues. The state  laboratory would also perform the more sophisticated confirmation testing  on the positive screens, which FDA could then use to take regulatory  action. According to FDA officials, the agency must first determine the  level of seafood sampling to perform given its other competing public  health priorities. They said that considerable funding would be required to  establish a meaningful laboratory assistance program with outside sources.
section_title: Private Laboratories Could Assist FDA If They Were Accredited
paragraphs: Currently, FDA does not accredit or use any private laboratories to collect  or analyze seafood samples. However, for some seafood violations, it does  allow seafood firms to use private laboratories to provide evidence that  imported seafood previously detained because of safety concerns is now  safe and can be removed from the detention list at the port of entry. To  assist FDA in analyzing more imported seafood, our panel recommended  that FDA accredit private laboratories that comply with FDA’s testing  methodologies. This option would also provide FDA with greater assurance  about the quality of the laboratories importers use to demonstrate that  their detained products are safe and can be released into commerce.
FDA officials said that using private laboratories to conduct screenings  could result in increased analytical capacity, but this option would require  more agency oversight, thereby making it a costly alternative. We note,  however, that FDA currently accepts the results from private laboratories  that importers provide to the agency to demonstrate that products detained  at ports of entry are safe and can be released into commerce. FDA also  noted that these private laboratories generally follow the appropriate  methodology for sampling, documentation, chain-of-custody, and analysis.
The agency performs a detailed review of the laboratories’ sampling and  testing methodology for each individual submission to FDA, but this review  is not an overall quality assurance review of the entire laboratory and  should not be taken as a general endorsement of the submitting laboratory.
As with state laboratories, if FDA were to use private laboratory results to  take regulatory action, it would be required to provide training and  oversight in addition to funding. However, FDA officials stated that in their  view, these laboratories are generally not equipped to perform  confirmation testing due to the expense and expertise required.  Furthermore, since private laboratories would continue to provide  laboratory analysis to the industry that FDA regulates, the agency would  have additional responsibilities to eliminate conflict of interest and protect  any regulatory testing from bias.
section_title: Private Third-party Firms Could Also Assist FDA, If Certified
paragraphs: In the absence of equivalence agreements, FDA could consider developing  a program that uses certified third-party firms to conduct HACCP  inspections on its behalf, both at foreign processing firms and domestic  importers. The Department of Health and Human Services has begun to  take this approach by accrediting third-parties to inspect manufacturers of  medical devices, as authorized by Congress. However, no similar specific  legislation exists permitting third-party inspection of seafood firms, and  FDA has not undertaken a comprehensive review of its authorities to  accredit private third-parties to inspect seafood firms.
Our expert panel believes that industry should pay for the use of these  third-parties to shift some of the burden from FDA to support the costs  associated with such a service. Following this approach, FDA could inspect  more foreign firms and importers without incurring substantial additional  costs. However, FDA is concerned that a fee-for-service arrangement for  these services would create a public perception of a conflict of interest.  According to our panel, to combat this potential problem, FDA would have  to implement a system of oversight to ensure that the third-parties are  adequately performing their duties. Finally, domestic importers could use  the accredited third-party firms to demonstrate that their seafood products  were processed in accordance with HACCP requirements.
section_title: Conclusions
paragraphs: Since FDA first issued the HACCP regulations for seafood safety in 1997,  U.S. seafood importers and foreign firms have made some progress in  implementing and demonstrating compliance with FDA’s seafood safety  requirements. However, FDA is still verifying compliance at only a small  number of seafood importers and foreign firms. Similarly, FDA’s port-of- entry product examination and testing is, and will continue to be, limited.  In addition, FDA is no longer making it a priority to negotiate equivalence  agreements with seafood-exporting countries, which remains one of the  most effective methods for ensuring the safety of imports. Indeed, our  panel of seafood safety experts believes that these agreements would help  FDA reduce its reliance on importer and port-of-entry inspections and  would enable the agency to leverage its staff resources by sharing the  responsibility for seafood safety with exporting countries, especially those  that are known to produce safe seafood. Coupled with the lack of timely  compliance and enforcement action, FDA’s efforts to ensure the safety of  imported seafood continue to provide insufficient protection to consumers.  Unless other options for strengthening these efforts are explored, the risk  of unsafe products released into the U.S. market will continue.
section_title: Recommendations for Executive Action
paragraphs: To more efficiently and effectively monitor the safety of imported seafood,  we recommend that the Secretary of Health and Human Services direct the  Commissioner of FDA to work toward developing a memorandum of  understanding with NOAA that leverages NOAA’s Seafood Inspection  Program’s resources. The memorandum of understanding should address  mutually agreeable protocols and training programs that are necessary to  begin using NOAA employees to provide various services. Those services  could include inspections of foreign firms, importer inspections, port-of- entry examinations and sample collections, and laboratory analyses.
To strengthen FDA’s current imported seafood program and ensure the  safety of seafood consumed in the United States, the Commissioner of FDA  should take the following five actions:  make it a priority to establish equivalence or other similar types of  agreements with seafood-exporting countries, starting first with  countries that have high-quality food safety systems;  develop and implement a system to track the time involved in  documenting, reviewing, and processing regulatory and enforcement  actions, such as issuing warning letters and detaining unsafe products,  so that FDA can identify the reasons for the delays and take actions to  address them;  give priority to taking enforcement actions when violations that pose  the most serious public health risk occur;  consider the costs and benefits of implementing an accreditation  program for private laboratories; and   explore the potential of implementing a certification program for third- party inspectors, which would involve reviewing FDA’s legal authorities  and considering the costs and benefits, including developing and  implementing the standards, controls, and oversight necessary to  provide FDA with reasonable assurance that third-party inspectors are  qualified and independent.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided FDA and NOAA with a draft of this report for review and  comment. We received written comments from the Commissioner, FDA,  which are presented in appendix IV. FDA also provided technical  corrections, which we have incorporated into the report as appropriate. We  received a letter from the Chief Administrative Officer, NOAA, stating that  the agency did not have any comments. The letter is presented in   appendix V.
Regarding the six specific recommendations we made in this report, FDA  generally concurred with five and disagreed with one. FDA generally  concurred that it should (1) work toward developing a memorandum of  understanding with NOAA that leverages NOAA’s Seafood Inspection  Program’s resources; (2) develop and implement a system to track the time  involved in documenting, reviewing, and processing regulatory and  enforcement actions so that FDA can identify the reasons for the delays  and take actions to address them; (3) give priority to taking enforcement  actions when violations that pose the most serious public health risk occur;  (4) consider the costs and benefits of implementing an accreditation  program for private laboratories; and (5) explore the potential of  implementing a certification program for third-party inspectors. Since we  will be reviewing FDA’s implementation of third-party inspections under  the Medical Device User Fee and Modernization Act of 2002, FDA could use  the results of this review in assessing the potential to use third-party  inspectors for imported seafood.
FDA did not concur with our recommendation to make it a priority to  establish equivalence or other similar types of agreements with seafood- exporting countries, starting first with countries that have high-quality food  safety systems. In commenting on this recommendation, FDA said the  agency is not currently positioned to assign high priority to negotiating  equivalence or other types of agreements with numerous countries that  export seafood to the United States in light of the pressing priorities  associated with implementation of the Bioterrorism Act. FDA also said that  establishing these agreements is extraordinarily resource intensive. We  agree that the process for creating these agreements is complex and  resource intensive; however, we continue to believe that it should be a  priority for FDA to negotiate equivalence or other less comprehensive  agreements with seafood exporting countries to leverage its limited  inspection resources. Additionally, FDA should view the creation of these  agreements as a long-term investment in improving imported seafood  safety. In the absence of equivalence or other agreements such as  memorandums of understanding with seafood-exporting countries, FDA  must continue to rely principally on reviews of importer records to  determine whether imported seafood is produced under acceptable food  safety systems.
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 has a higher likelihood of causing foodborne illness than other  foods on the basis of a comparison of the number of foodborne illness  outbreaks in the United States from seafood-related causes than from meat  and poultry. FDA also said that our draft report did not acknowledge that  foodborne illness outbreaks associated with seafood also include those  from recreational and subsistence fishing, over which the federal  government has little or no control. We modified this report to include the  actual number of cases associated with seafood and meat and poultry  outbreaks. We also added CDC’s observation 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 that result from nonspecific gastrointestinal  symptoms caused by other foods. Additionally, we added FDA’s comment  that some seafood-related illnesses may be caused by recreational or  subsistence fishing, over which the federal government has little or no  control.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution of it until 30 days from  the date of this letter. We will then send copies to interested congressional  committees; the Secretary of Health and Human Services; the NOAA  Administrator; the United States Trade Representative; the Director, Office  of Management and Budget; and other interested parties. We will make  copies available to others on request. In addition, the report will be  available at no charge on GAO’s Web site at http://www.gao.gov.
If you or your staff have any questions about this report, please call me at  (202) 512-3841. Key contributors to this report are listed in appendix VI.
section_title: Scope and Methodology
paragraphs: To reevaluate the Food and Drug Administration’s (FDA) program for  ensuring the safety of imported seafood and determine the status of efforts  to implement our previous recommendations, we interviewed cognizant  government and industry officials. Specifically, we interviewed officials  and/or reviewed documents from the following FDA units: Center for Food  Safety and Applied Nutrition’s Office of Seafood, Office of Compliance, and  Office of Constituent Operations; Office of Regulatory Affair’s Office of  Enforcement, Office of Regional Operations, and Office of Resource  Management; Office of Chief Counsel; and Office of International  Programs. We also visited the FDA district office in Bothell, Washington,  where large volumes of seafood are processed, and we met with FDA  officials to discuss relevant regulations, policies, and procedures. We also  visited two U.S. importers to observe FDA’s importer inspection process  firsthand and to discuss their views.
To assess the progress that FDA has made since our 2001 report, we  analyzed the agency’s inspection records of U.S. importers. Specifically, we  randomly selected a probability sample of 117 inspections from a list of 415  importer inspections that nominally represented all importer inspections  conducted by FDA for fiscal year 2002. From this sample, 13 inspections  were outside the scope of this assignment—for example, they were for  molluscan shellfish or the seafood actually was a domestic product. In  addition, for 8 additional in-scope inspections, FDA could not locate  complete documentation (6 inspections); and FDA did not complete a  standardized inspection form (Form 3502) at the time of the inspection (2  inspections).
For the 96 in-scope inspections for which documentation was found, we  analyzed the Form 3502 that investigators completed for each imported  seafood product during fiscal year 2002. The 96 inspections were  associated with a total of 112 Forms 3502.
Because we followed a probability procedure based on a random selection  of inspections (and thereby products), our sample is only one of a large  number of samples we might have drawn. Since each sample could have  provided different estimates, we express the confidence in the precision of  our particular sample’s results as 95 percent confidence intervals (e.g., ± 7  percentage points). These are intervals that would contain the actual  population values for 95 percent of the samples we could have drawn. As a  result, we are 95 percent confident that each of the confidence intervals in  this report will include the true values in the study population.
The estimate that 48 percent of U.S. importers’ products had the required  documentation is surrounded by a 95 percent confidence interval that  ranges from 36 percent to 60 percent. We estimated that 4 percent of the  FDA inspection forms erroneously indicate that the United States has an  equivalence agreement with the exporting country. This estimate is  surrounded by a 95 percent confidence interval that ranges from 1 percent  to 10 percent.
To assess FDA’s progress with regard to inspections of foreign firms, we  obtained 107 of 108 foreign inspection reports for fiscal year 2002 for the 13  countries that FDA visited—Brazil, China, Costa Rica, Honduras, Iceland,  Jamaica, Mexico, Poland, Taiwan, Thailand, Trinidad and Tobago, Uruguay,  and Vietnam. Of these 107 inspection reports, we removed 8 because they  covered shellfish, which was outside the scope of our review. We compared  FDA’s findings for the remaining 99 inspections with FDA’s actions at U.S.  ports of entry.
For the sample of importer inspections and the entire set of the foreign firm  inspections, FDA provided inspection results in hard copy because FDA  investigators do not transmit information electronically. FDA also provided  us with summary data from the system used to maintain inspection results  for our analyses of foreign firm and importer inspections. We conducted a  data reliability assessment of the importer and foreign firm inspection  information, which indicated that the data and data systems used by FDA  were sufficiently reliable and complete to perform our analyses.
To assess the time frames for issuing warning letters and other pertinent  information, we analyzed the 20 warning letters FDA issued following its  foreign firm inspections and the 8 warning letters FDA issued following its  U.S. importer inspections conducted during fiscal year 2002 that FDA  determined warranted enforcement action. Recognizing FDA’s time frame  of 30 work days for FDA to process a warning letter, we did not consider  any warning letter issued within 45 calendar days after the date of  inspection as having exceeded FDA’s issuance time frame.
In addition, we interviewed and/or received documents from the National  Oceanic and Atmospheric Administration’s (NOAA) National Marine  Fisheries Service, Seafood Inspection Program, and National Sea Grant  Program. 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.  We also met with the Center for Science in the Public Interest—a consumer  organization focusing on nutrition and food safety—which investigates and  reports on outbreaks of foodborne illnesses. Finally, we spoke with  officials from the Canadian Food Inspection Agency to discuss their  regulations for ensuring the safety of imported seafood and to gain insight  on agreements that Canada established with other foreign countries’ food  inspection authorities. We also received information from the Department  of Agriculture about its program for requiring equivalence determinations  before allowing exported meat and poultry products to enter the United  States. However, the scope of this review did not include exploring whether  Agriculture could make inspection or other resources available to augment  FDA’s seafood inspection program.
To explore other options for enhancing FDA’s existing imported seafood  safety program, we assembled a panel of recognized experts on the  following seafood-related areas: seafood policy, laws, and regulations  (including HACCP); public health, epidemiology, and microbiology; risk  management and assessment; and international trade policy. With advice  from the National Academies, we selected 63 seafood safety experts as  potential panelists. From these 63 contacts, we chose the final nine  panelists on the basis of the following criteria: (1) recommendations we  received from the National Academies and participation on previous  academy panels; (2) recommendations from others knowledgeable in the  field of seafood safety; (3) the individual’s area of expertise and experience;  (4) the type of organization represented, including academic institutions,  seafood industry, trade groups, and consumer groups; and (5) geographic  representation. (The names and affiliations of the panel members are listed  in app. II.) On July 2, 2003, we held an all-day meeting with the nine  panelists at our office in Washington, D.C. Before the meeting, we provided  each panel member with a set of four general discussion questions. At the  end of each discussion, we asked the panelists to respond, using an  anonymous ballot, to a set of questions that were based on the general  discussion topics. We recorded and transcribed the meeting to ensure that  we accurately captured the panel members’ statements.
We conducted our review from February 2003 through November 2003 in  accordance with generally accepted government auditing standards.
section_title: Summary of Expert Panel Observations on the Safety of Imported Seafood
paragraphs: This appendix provides the names and affiliation of our expert panel  members and summarizes the discussions held at the all-day meeting. The  information presented in this appendix may not represent the views of  every member of the panel. Also, this information should not be considered  to be the views of GAO.
subsections: section_title: Members of Our Expert Panel
paragraphs: The following individuals were members of our expert panel on the safety  of imported seafood:  Haejung An, Associate Professor, Department of Nutrition and Food  Science, Auburn University;  Tom Chestnut, Vice President, Total Quality, Darden Restaurants;  Bob Collette, Vice President, Science and Technology, National   Cameron Hackney, Dean, Davis College of Agriculture, Forestry and  Consumer Sciences, West Virginia University;  Michael Jahncke, Director, Virginia Seafood Agricultural Research and  Extension Center, Virginia Polytechnic Institute and State University;  Michael Moody, Professor and Head, Department of Food Science,   W. Steven Otwell, Professor, Seafood Technology, Department of Food  Science and Human Nutrition, University of Florida;  Barbara Rasco, Associate Professor, Department of Food Science and  Human Nutrition, Washington State University; and  Caroline Smith DeWaal, Director, Food Safety Approach, Center for  Science in the Public Interest.
section_title: Summary of Panel Observations
paragraphs: On July 2, 2003, we held an all-day meeting with the nine panelists at our  office in Washington, D.C. Before the meeting, we provided each panel  member with a set of four general discussion questions. At the end of each  discussion, we asked the panelists to respond, using an anonymous ballot,  to a set of questions that were based on the general discussion topics. We  recorded and transcribed the meeting to ensure that we accurately  captured the panel members’ statements. The panelists discussed two  overarching themes: (1) changes that FDA has made to improve its ability  to ensure imported seafood safety and (2) options for improving FDA’s  current regulatory approach.
subsections: section_title: FDA’s Recent Changes
paragraphs: Since our last report on this matter in 2001, FDA has made changes to its  approach for ensuring the safety of imported seafood. Panelists specifically  discussed these changes, including (1) a shift in focus from inspecting  foreign countries’ entire food safety systems for equivalence to inspecting  more foreign firms for HACCP compliance, (2) a slight increase in the  number of port-of-entry examinations and laboratory testing of imported  seafood, and (3) an increase in testing for aquaculture drug residues.  Specifically:   Panelists suggested that inspecting a small number of foreign firms for  HACCP compliance, rather than inspecting foreign countries’ entire  food safety systems for equivalence, is ineffective because FDA only  inspects about 100 seafood firms in 10 countries annually, out of a  universe of an estimated 13,000 firms in about 160 countries.
Panelists believed that increasing the number of port-of-entry  examinations and laboratory testing for imported seafood, while  desirable, would be ineffective because this approach is not consistent  with the preventative HACCP approach.
Because regulatory authorities around the world are increasingly  finding aquaculture drug residues, the panelists believed that more  testing for drug residues would be a valuable verification step in an  effective HACCP system. Furthermore, panelists believed that FDA  should shift its focus to the source of production to prevent the abuse of  legal substances or the use of banned aquaculture drugs.
section_title: Options for Improving the Current Regulatory Approach
subsections: section_title: Equivalence Agreements
paragraphs: Panelists recommended that FDA establish equivalence agreements in  order to more efficiently utilize its limited resources. They believed that  equivalence agreements would be more effective than FDA’s direct  inspection of foreign firms for ensuring HACCP compliance and would  also allow the agency to focus resources on the countries, firms, and  products that pose the greatest risk, thereby shifting the burden for  HACCP compliance from FDA to foreign governments and foreign firms.  Panelists stated that such agreements should not imply that FDA must  find a foreign government’s seafood safety system “equal” to that of the  U.S. system. For example, panelists said that FDA should have flexibility  in terms of what it considers equivalent and should also consider  alternatives to country-to-country agreements (e.g., product-to-country,  company-to-country, and hazard-specific agreements).
The panel recommended that FDA first consider one-way equivalence  agreements, with counties where the United States imports large  quantities of seafood but does not export significant quantities.  Although panelists noted that two-way agreements are preferred, they  believed that using one-way equivalence agreements initially would  better ensure that foreign firms are meeting U.S. standards. However,  U.S. seafood exporters may object to one-way agreements, arguing that  these would favor the foreign countries, which may have barriers to U.S.  exports.
Panelists recommended that FDA establish a timeline for agreements,  although there was no consensus on the best way to develop this  timeline. Possible suggestions included a phased-in process, based on  the quantity of exports to the United States, and the establishment of  agreements based on the willingness of participants.
Panelists believed that Congress should mandate that FDA establish  equivalence agreements; however, FDA should be allowed to determine  how the agreements are structured and implemented. The panel also  expressed concern that our trading partners could view mandating  equivalence as protectionist. Additionally, panelists said FDA should  still implement third-party certification and auditing if equivalence is  mandated.
The panel believed that FDA should provide additional training and  education to foreign governments and foreign firms on HACCP  requirements, and that industry should pay for this training.
section_title: Importer Inspections
paragraphs: Panelists recommended that FDA identify competent inspection  authorities to establish lists of preferred suppliers, in which the foreign  government inspects firms wishing to export to the United States, to  assure the agency that these firms meet HACCP requirements. By  adopting this approach, FDA could then target inspection and testing  resources to nonpreferred suppliers.
Panelists recommended that FDA develop an accreditation program for  private laboratories that demonstrate compliance with FDA’s testing  methodologies. FDA could then establish a list of approved, accredited  domestic laboratories to augment their port-of-entry testing for  compliance and enforcement. Additionally, domestic importers could  use the accredited foreign and domestic laboratories to demonstrate,  through testing, that their seafood products were processed in  accordance with HACCP requirements. Panelists believed that most  domestic private laboratories are capable of meeting FDA’s standards,  such as sample chain-of-custody, laboratory procedure, and qualified  analysts, and could provide timely results.
section_title: Foreign Firm Inspections
paragraphs: Panelists recommended that FDA establish a standardized program to  certify private, third-party inspectors to conduct HACCP inspections of  foreign processing firms and domestic importers. The third-party  inspectors would be paid for by industry and monitored by FDA, thereby  allowing for more foreign firm and importer inspections at little  additional cost to FDA.
Panelists recommended that FDA place more responsibility on foreign  governments to ensure that foreign firms are aware of, and are meeting,  their responsibilities under HACCP. Under an effective HACCP system,  the panelists felt that FDA’s emphasis should be on inspection and  testing in the foreign country where the seafood is harvested and  processed and where hazards are introduced.
Panelists recommended that when problems are discovered as a result  of inspections of foreign firms or importers, FDA should discuss with  the exporting countries how to prevent these problems from  reoccurring.
section_title: Port-of-entry Examinations and Testing
paragraphs: Panelists suggested that state regulatory laboratories (e.g., those  operated by the state Department of Health or Agriculture) may be a  good option for assisting FDA in testing imported seafood products,  particularly in those states with ports and seafood industries. State  laboratories provide comparable testing for state regulatory authorities  and have procedures in place that could meet FDA’s standards for  compliance testing. State laboratories are also well equipped for food  testing and provide reliable results. Panelists did note, however, that  most states are financially constrained, and therefore state laboratories  may not have any excess capacity (e.g., qualified analysts, equipment  time, or laboratory space) to analyze additional samples for FDA.  Furthermore, in order to use the facilities, FDA would need to  harmonize testing methodologies.
Panelists suggested that FDA use the National Marine Fisheries Service  laboratories in Pascagoula, Mississippi, and Seattle, Washington, to  augment testing at ports of entry. Panel members believed that this was  a good option for FDA because these laboratories currently conduct  seafood research and testing.
Panelists did not recommend that FDA use academic laboratories for  testing at ports of entry. They stated that most academic laboratories are  not structured to do compliance testing and would not meet FDA’s  standards for chain of custody of the samples or acceptable  documentation for compliance or enforcement actions.
section_title: Results of GAO Analysis of FDA’s Inspections of 99 Foreign Firms, Fiscal Year 2002
section_title: Comments from the Food and Drug Administration
paragraphs: The following are GAO’s comments on the Food and Drug Administration’s  letter dated January 8, 2004.
subsections: section_title: GAO Comments
paragraphs: 1. We modified our report to state that although FDA does not have an  automated system for computing the time it takes to review warning  letter and untitled letter recommendations, it is in the early stages of  developing such a system.  This system will enable FDA to track the  time involved in documenting, reviewing, and processing enforcement  actions.   2. We modified this report to include the actual number of cases  associated with seafood and meat and poultry outbreaks.  We also  added the Centers for Disease Control and Prevention’s observation  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 that result from  nonspecific gastrointestinal symptoms caused by other foods.   Additionally, we added FDA’s comment that some seafood-related  illnesses may be caused by recreational or subsistence fishing, over  which the federal government has little or no control. 3. As shown in our report, FDA inspects only a small percentage of U.S.  importers, examines and samples a very small amount of imported  seafood at U.S. ports of entry, and inspects few seafood firms in foreign  countries each year.  In the absence of equivalence or other agreements  such as memorandums of understanding with seafood-exporting  countries, FDA must continue to rely principally on reviews of importer  records to determine whether imported seafood is produced under  acceptable food safety systems.  For these reasons, we continue to  believe that FDA should develop such agreements as quickly as  possible.  Moreover, FDA acknowledged in its final HACCP rule, issued  in December 1995, that in the absence of significant numbers of agency  inspections of foreign processing facilities, a memorandum of  understanding can be the most efficient and effective mechanism for  ensuring that foreign processing plants are operating in compliance  with the requirements of the regulations.      4. We modified this report to include FDA’s basis for issuing these letters. 5. We acknowledge that establishing equivalence or other agreements is  complex and resource intensive.  However, we continue to believe, as  supported by our panel of nationally recognized food safety experts,  that equivalence agreements or less comprehensive alternatives, such  as compliance agreements or memorandums of understanding  represent a more effective long-term approach for ensuring the safety  of imported seafood and would allow FDA to leverage its staff  resources by shifting some of its regulatory burden to exporting  countries.  Also, U.S. importers would be able to rely on the foreign  regulatory authority to ensure compliance with HACCP requirements  by foreign processors.
Also see comment 3. 6. Our report recognizes that FDA is beginning to take action to develop  an automated system to track the time involved in documenting,  reviewing, and processing regulatory actions.
Also see comment 1.
section_title: Comments from the National Oceanic and Atmospheric Administration
section_title: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
section_title: Staff Acknowledgments
paragraphs: In addition to the individuals named above, John C. Smith, Kenya Jones,  and Lisa Vojta made key contributions. Other contributors included, Aldo  Benejam, Oliver Easterwood, Lynn Musser, Cynthia Norris, Paul Pansini,  Katherine Raheb, Carol Herrnstadt Shulman, Sidney Schwartz, and Kathy  Summers.
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