    Food Safety: FDA's Imported Seafood Safety Program Shows Some
    Progress, but Further Improvements Are Needed (30-JAN-04,
    GAO-04-246).

    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.
    -------------------------Indexing Terms-------------------------
    REPORTNUM:   GAO-04-246
        ACCNO:   A09187
      TITLE:     Food Safety: FDA's Imported Seafood Safety Program Shows
    Some Progress, but Further Improvements Are Needed
         DATE:   01/30/2004
      SUBJECT:   Consumer protection
    	     Contaminated foods
    	     Food inspection
    	     Health hazards
    	     Importing
    	     Performance measures
    	     FDA Hazard Analysis and Critical Control
    	     Point System

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    GAO-04-246

    United States General Accounting Office

    GAO

                           Report to Congressional Requesters

    January 2004

    FOOD SAFETY

         FDA's Imported Seafood Safety Program Shows Some Progress, but Further
                                Improvements Are Needed

                                           a

    GAO-04-246

    Highlights of GAO-04-246, a report to congressional requesters

    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.

    GAO recommends that FDA (1) work toward developing a memorandum of
    understanding with NOAA to use NOAA's resources; (2) make it a priority to
    establish equivalence or other agreements, starting with countries having
    high-quality food safety systems; (3) develop a system to track the time
    involved in processing enforcement actions; (4) give enforcement priority
    to violations posing the most serious risks; (5) consider accrediting
    private laboratories; and (6) explore the potential for certifying
    third-party inspectors. FDA generally agreed with all but the
    recommendation on making it a priority to establish equivalence or other
    agreements.

    January 2004

    FOOD SAFETY

    FDA's Imported Seafood Safety Program Shows Some Progress, but Further
    Improvements Are Needed

    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.

    www.gao.gov/cgi-bin/getrpt?GAO-04-246.

    To view the full product, including the scope and methodology, click on
    the link above. For more information, contact Lawrence J. Dyckman at (202)
    512-3841 or dyckmanl@gao.gov.

    Contents

      Letter

    Results in Brief
    Background
    FDA's Imported Seafood Safety Program Shows Some Improvement,

    but Deficiencies Persist Options Are Available for Enhancing FDA's
    Imported Seafood Safety

    Program, but They Present Challenges Conclusions Recommendations for
    Executive Action Agency Comments and Our Evaluation

    1 4 7

    13

    24 29 29 30

    Appendixes

    Appendix I:

    Appendix II:

                              Appendix III: Appendix IV: Appendix V: Appendix VI:

    Scope and Methodology

    Summary of Expert Panel Observations on the Safety of Imported Seafood

    Members of Our Expert Panel Summary of Panel Observations

    Results of GAO Analysis of FDA's Inspections of 99 Foreign Firms, Fiscal
    Year 2002

    Comments from the Food and Drug Administration

    GAO Comments

    Comments from the National Oceanic and Atmospheric Administration

    GAO Contacts and Staff Acknowledgments

    GAO Contacts
    Staff Acknowledgments

    33

    37 37 37

    42

    43 52

    54

    55 55 55

    Figures	Figure 1: Figure 2:

    Figure 3:

    Figure 4: Figure 5:

    U.S. Seafood Consumption and Imports, 1993 to 2002 9
    Percentage of Seafood Imports to the United States from
    Major Exporting Countries, 2002 10
    Status of FDA's Program Approaches for Ensuring the
    Safety of Imported Seafood, Fiscal Years 1999 and
    2002 14
    Importers' Regulatory and Compliance Requirements 15
    Number of Days from Inspection to Issuance of Warning
    Letters for Serious Violations Found at 20 Foreign Firms,
    Fiscal Year 2002 22

    Contents

    Abbreviations

    CCP critical control point
    CDC Centers for Disease Control and Prevention
    CFIA Canadian Food Inspection Agency
    DWPE detention without physical examination
    FDA Food and Drug Administration
    HACCP Hazard Analysis and Critical Control Point (system)
    NOAA National Oceanic and Atmospheric Administration
    USTR Office of the U.S. Trade Representative

    This is a work of the U.S. government and is not subject to copyright
    protection in the United States. It may be reproduced and distributed in
    its entirety without further permission from GAO. However, because this
    work may contain copyrighted images or other material, permission from the
    copyright holder may be necessary if you wish to reproduce this material
    separately.

    A

    United States General Accounting Office Washington, D.C. 20548

    January 30, 2004

    The Honorable Ernest F. Hollings
    Ranking Minority Member
    Committee on Commerce, Science, and Transportation
    United States Senate

    The Honorable Trent Lott
    United States Senate

    The Honorable John Breaux
    United States Senate

    More than 80 percent of the seafood that Americans consume is imported
    from an estimated 13,000 foreign suppliers in about 160 nations.1 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.2

    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.

    1According to the National Marine Fisheries Service, National Oceanic and
    Atmospheric Administration, the percentage of imported seafood is based on
    live weight.

    2CDC derives estimates of foodborne illness from, among other things,
    reported occurrences of two or more cases of a similar illness resulting
    from the ingestion of a common food, which is referred to as an outbreak.
    It publishes foodborne disease outbreaks in 5-year increments. These
    percentages are based on the most recent CDC data available, published in
    March 2000 and covering 1993 to 1997.

    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.3 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).4 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.

    3Among other things, FDA considers a product to be adulterated if it
    contains bacterial contamination or prohibited chemical substances, or if
    it has been produced without a HACCP plan.

    4The Agricultural Marketing Act of 1946 authorized the Seafood Inspection
    Program. The program was transferred from the Department of Agriculture to
    the Department of the Interior in 1956 and subsequently to the Department
    of Commerce in 1970.

    In 2001, we reported that FDA's oversight of domestic and imported seafood
    provided insufficient assurance that the seafood is safe.5 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

    5U.S. General Accounting Office, Food Safety: Federal Oversight of Seafood
    Does Not Sufficiently Protect Consumers, GAO-01-204 (Washington, D.C.:
    Jan. 31, 2001).

    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.

    Results in Brief	FDA has made some improvements to its imported seafood
    safety program since our January 2001 report, but it has not acted on key
    recommendations we made at that time. In terms of improvements, FDA
    investigators have found that more importers have the required
    documentation to demonstrate compliance with U.S. food safety
    requirements, and FDA now inspects more foreign firms in countries that
    supply seafood to the United States. FDA also increased laboratory testing
    of seafood products at ports of entry from less than 1.0 percent in fiscal
    year 1999 to about 1.2 percent in fiscal year 2002. However, the agency
    has not addressed our recommendations to improve imported seafood safety.
    Specifically, FDA has not, as we recommended done the following:

    o 	Developed goals and time frames for establishing equivalence agreements
    with seafood exporting countries. Consequently, FDA continues to rely, in
    part, on reviewing importers' records to ascertain whether imported
    products are processed under an acceptable food safety system. Although
    FDA did not agree with our recommendation, it said that it would continue
    to assess the equivalency of foreign countries' seafood safety systems and
    enter into agreements as appropriate. It also said that this effort would
    be a priority. FDA officials now report that the costs of developing such
    agreements may outweigh the food safety benefits and, therefore, these
    assessments are no longer an FDA priority. Furthermore, FDA officials'
    attention and resources are now more focused on biosecurity issues. Our
    food safety panel considered these arguments and concluded that FDA should
    pursue equivalence agreements or other less comprehensive agreements, such
    as product-specific agreements, in order to shift some of the burden for

    HACCP compliance to foreign governments, manufacturers, and processors.
    The panelists suggested that FDA focus first on establishing agreements
    with countries that have high-quality food safety systems- an approach
    that would conserve FDA resources to inspect products from countries with
    less advanced food safety systems.

    o 	Communicate to port-of-entry personnel the serious deficiencies
    identified during importer and foreign country inspections, so that
    potentially contaminated imported seafood is examined before entry into
    the United States. FDA continues to experience long delays in this regard.
    For example, in 2002, FDA took an average of 348 days to alert
    port-of-entry personnel about serious safety problems identified with
    seafood products from six foreign firms. Even when FDA investigators had
    recommended immediate detention of imported seafood shipments, based on
    foreign firm inspections, the agency did not take this action because its
    policy is to first forward all recommendations to headquarters for review.
    When we brought these delays to headquarters officials' attention, they
    stated that the agency does not have an automated system for documenting
    the time involved in reviewing these recommendations but that such delays
    are unacceptable. This lack of management oversight fails to give priority
    to taking enforcement action for serious violations, and it increases the
    likelihood that unsafe products will enter the U.S. market.

    Regarding our second objective-to explore other options for enhancing
    FDA's imported seafood inspection program-we identified four alternatives
    that can help augment FDA's inspection resources at ports of entry and in
    foreign countries and also increase the agency's laboratory capacity to
    test imported seafood products. Given FDA officials' concerns about
    limited inspection resources and competing priorities, the following
    options may provide useful alternatives, but they also present some
    challenges.

    o 	Use NOAA's Seafood Inspection Program personnel to augment FDA's
    inspection capabilities. According to NOAA officials, they could provide
    FDA with an estimated 22 full-time-equivalent inspectors to, among other
    things, assist with inspections of U.S. importers and foreign firms and
    with examinations and sampling of imported seafood at ports of entry. FDA
    acknowledges that it has the legal authority to commission NOAA employees
    to conduct inspections and investigations on FDA's behalf by entering into
    a memorandum of understanding. However, some FDA officials are concerned
    that this option has the

    potential for a conflict of interest because NOAA inspections are based on
    fee-for-service. FDA also believes that NOAA inspectors would need
    additional training.

    o 	Use state regulatory laboratories to augment FDA's capacity for
    analyzing imported seafood. FDA is already considering using at least one
    state regulatory laboratory. According to our expert panel, this option
    has merit since these laboratories have capabilities and procedures
    similar to FDA's, but the panel and FDA noted that most state laboratories
    may not have excess capacity to perform testing.

    o 	Use private testing laboratories to assist in screening seafood
    samples. Our expert panel said, however, that FDA would first need to
    develop and implement an appropriate accreditation program. FDA recognizes
    that it would get quicker results if it adopted this option but noted that
    doing so would require more agency oversight, thereby making this a costly
    alternative.

    o 	Develop a program for using private, independent inspectors (thirdparty
    inspectors) to inspect foreign processing firms and domestic importers.
    Such a program would be similar to one that FDA has just begun to operate
    for third-party inspections of medical device manufacturers that was
    specifically authorized by Congress. To implement this option, FDA would
    need to develop and implement an appropriate certification program.
    However, FDA has not undertaken a comprehensive review of its legal
    authorities in this area.

    To enhance FDA's ability to ensure the safety of imported seafood, we are
    making six recommendations, one to the Secretary of Health and Human
    Services and five to the Commissioner of FDA that are designed to
    strengthen aspects of the existing program. In commenting on a draft of
    this report for the Department of Health and Human Services, FDA
    essentially concurred with five of our recommendations and disagreed with
    one. FDA disagreed that it should make it a priority to establish
    equivalence or other agreements. We continue to believe that equivalence
    agreements are one of the most cost-effective methods for ensuring the
    safety of imported seafood. We also provided a draft of this report to
    NOAA, which did not have any comments on the report's findings,
    conclusions, or recommendations.

    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.6 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
    foodpoisoning 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 2002.7

    Several types of hazards can cause seafood-related illnesses.
    Specifically:

    o 	Biological hazards-include pathogens, such as Clostridium botulinum,
    Listeria monocytogenes, Salmonella species, and Staphylococcus aureus, and
    parasites such as roundworms and tapeworms.

    6According to CDC, only a fraction of foodborne illnesses are routinely
    reported, and since most foodborne illnesses are sporadic, only a small
    number of them are identified as being part of an outbreak.

    7Outbreaks include those that are linked to finfish; other seafood (e.g.,
    crab and shrimp); and seafood dishes, which may include molluscan
    shellfish (oysters, clams, mussels, and whole or roe-on scallops).

    o 	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, 8 including
    gastrointestinal and neurological problems. These toxins are heat
    resistant and cannot be inactivated by cooking.

    o 	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.9

    8FDA noted that a number of illnesses from ciguatoxin are from
    recreational versus commercial fishing, but the agency did not provide any
    specific data.

    9Consumption data are based on edible portions of seafood from imported
    and domestic sources. Import data are based on both edible and inedible
    portions of seafood, including bones.

              Figure 1: U.S. Seafood Consumption and Imports, 1993 to 2002

    Billions of pounds

            1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 Calendar year

    Total consumption Imports

    Source: National Marine Fisheries Service, National Oceanic and
    Atmospheric Administration.

    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.10 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.

    10U.S. seafood consumption data include finfish, shellfish, and other
    aquatic plants and animals.

    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 seafoodprocessing 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:

    o 	Conduct a hazard analysis. Identify hazards that are reasonably likely
    to occur.

    o 	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.

    o 	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.

    o 	Monitor each CCP. Establish monitoring activities that will ensure that
    the process is under control at each CCP.

    o 	Establish corrective actions. Define actions to be taken when
    monitoring discloses a deviation from established critical limits.

    o 	Establish verification procedures. Establish verification procedures to
    ensure that HACCP plans accomplish their intended goal-that is, ensuring
    the production of safe products.

    o 	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.11 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

    11World Trade Organization Agreement on the Application of Sanitary and
    Phytosanitary Measures, art. 4, 1994.

    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 2002.12 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-ofentry examinations and laboratory testing; and conducting foreign
    inspections that focused on high-risk foods, including seafood.

    FDA's Imported Seafood Safety Program Shows Some Improvement, but
    Deficiencies Persist

    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.

    FDA's Program Shows Some Improvement Since Our Last Report

    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.

    12The Public Health Security and Bioterrorism Preparedness and Response
    Act of 2002, Pub.

    L. No. 107-188; 116 Stat. 594 (2002).

    Figure 3: Status of FDA's Program Approaches for Ensuring the Safety of
    Imported Seafood, Fiscal Years 1999 and 2002

    Program approaches Status

    Source: GAO analysis of 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.

    Figure 4: Importers' Regulatory and Compliance Requirements

    Importers purchase seafood from countries that have equivalence agreements
    with FDA

    Importers cannot use this option because there are no equivalence
    agreements

    Regulations

    require that importers meet one of two conditions (A or B)

    1. Importers must maintain a written product specification for each
    product

    and

    2. Importers must document at least one of six affirmative steps for each
    product

    a. HACCP and sanitation records from processor

    b. continuing or lot-by-lot certification from foreign inspection
    authority or third-partya

    c. regular inspection of foreign processor

    d. copy of HACCP plan from processor and written guarantee that the
    imported seafood product is processed in accordance with HACCP
    requirements

    e. periodic testing of the imported product and a copy of the written
    guarantee that the imported seafood product is processed in accordance
    with HACCP requirements

    f. other appropriate verification measures

                                Source: FDA regulations.

    aApproved foreign processor lists may serve as meeting the continuing
    certification affirmative step.

    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.13 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 1999.14 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).15 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.

    13To record importer inspection findings, FDA investigators complete a
    product-specific standardized form after each importer is inspected. The
    forms indicate whether importers have the required documentation and, if
    so, whether the documents establish the foreign firm's compliance with
    U.S. HACCP requirements.

    14As stated in our January 2001 report (GAO-01-204), we obtained and
    analyzed all of the FDA inspection forms for fiscal year 1999 that were
    completed at 350 importer firms (covering 432 seafood products). On
    November 20, 2003, FDA revised the number of domestic importers inspected
    to 644 during fiscal year 1999 and reported that the agency inspected 676
    importers, or about 8 percent of importers inspected during fiscal year
    2003.

    15To meet the affirmative step requirement, importers may choose to
    purchase seafood from firms appearing on lists approved by foreign
    governments. These governments are assuring FDA that firms on the lists
    meet U.S. HACCP requirements. FDA acknowledges the approved lists from
    four foreign countries' inspection authorities: Canada, Japan, New
    Zealand, and Thailand.

    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.16 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.

    16FDA officials commented that the percentage of imported seafood that is
    tested is higher if the number of samples collected and tested by
    importers under DWPE is counted. However, the agency provided no data on
    the amount of testing conducted under DWPE.

    FDA Still Lacks Equivalence or Other Agreements with Seafood Exporting
    Countries

    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.17 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.18 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

    17The compliance agreement being discussed with Japan is for specific
    seafood products.

    18Codex is an international food standard-setting body under the joint
    oversight of the United Nations Food and Agriculture Organization and the
    World Health Organization.

    and audits in these countries.19 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.20 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

    19USTR also told us that guidelines completed by Codex in July 2003 are
    still too abstract for FDA to use to determine equivalence.

    20Under the meat and poultry inspection acts, the Secretary of the
    Department 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.

    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.

    Most FDA Regulatory Actions Are Not Timely

    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.21 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.

    21FDA field offices may issue without prior headquarters review warning
    letters for certain violations found during U.S. importer inspections,
    such as not having written product specifications.

    FDA issues untitled letters when the documented violations do not meet the
    criteria for detention.22 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.23 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

    22As previously noted, under the DWPE process, FDA can also refuse
    admission of imported products on the basis of information, such as
    foreign firm inspections, that the product appears to be adulterated. The
    products are subject to refusal of admission until the violations found
    during inspection are corrected.

    23FDA classifies inspections as (1) No Action Indicated-no objectionable
    conditions found, (2) Voluntary Action Indicated-objectionable conditions
    found but are not sufficient to warrant regulatory action, or (3) Official
    Action Indicated-serious violations are found that warrant regulatory
    action.

    delays in issuing warning letters when serious violations are
    identified.24 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.

    Figure 5: Number of Days from Inspection to Issuance of Warning Letters
    for Serious Violations Found at 20 Foreign Firms, Fiscal Year 2002

                            Number of warning letters issued

                                           8

    45a

                        46 to 90 91 to 135 136 to 180 181 to 225

    226

    Days from inspection to issuance

    Source: GAO analysis of FDA data.

    aFDA's requirement is to issue warning letters within 30 work days (or
    about 45 calendar days).

    Fourteen of these 20 warning letters were issued to firms producing
    highrisk products25-such as semipreserved fish products, including smoked,

    24We received and reviewed 107 of the 108 foreign firm inspection records
    that FDA conducted in fiscal year 2002. Of the 107 files received, we
    removed 8 inspections because they covered shellfish, which was outside
    the scope of this assignment.

    25According to FDA, high-risk foods are those that may contain hazards
    that the agency believes present a higher potential to cause harm to
    humans.

    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.26 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-ofentry 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 scombrotoxinsusceptible
    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

    26As of October 8, 2003, FDA received adequate responses from 8 of these
    14 firms, is considering enforcement action for 5 firms, and has not
    received a response from 1 firm.

    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.

    Options Are Available for Enhancing FDA's Imported Seafood Safety Program,
    but They Present Challenges

    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.

    NOAA's Seafood Inspection NOAA officials said that they could assist FDA
    by providing various Personnel and Laboratories services to augment FDA's
    regulatory program for imported seafood. These

    Could Augment FDA's services include

    Regulatory Program  o  foreign firm inspections,

    o  HACCP training,

    o  domestic importer inspections,

    o  port-of-entry inspection and product sampling, and

    o 	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.27

    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

    27FDA plans to collect and analyze over 500 shrimp samples for
    chloramphenicol in fiscal year 2003 using its own laboratories. These
    laboratories would also be used to confirm the presence of chloramphenicol
    in positive samples found by the NOAA laboratories.

    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.

    State Regulatory Laboratories Have the Capability, but May Not Have the
    Capacity, to Assist FDA

    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

    o 	state laboratories are well equipped for food testing and provide
    reliable results,

    o 	these laboratories have procedures in place that could meet FDA's
    standards for compliance testing, and

    o 	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.

    Private Laboratories Could Assist FDA If They Were Accredited

    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.

    Private Third-party Firms Could Also Assist FDA, If Certified

    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.28 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

    28Congress enacted the Medical Device User Fee and Modernization Act of
    2002 on October 26, 2002, Pub. L. No. 107-250, 116 Stat. 1588 (2002). GAO
    is required to review implementation of the third-party inspection program
    and submit a report to Congress no later than October 26, 2006. The report
    is also required to include a recommendation as to whether the program
    should be continued or terminated.

    the accredited third-party firms to demonstrate that their seafood
    products were processed in accordance with HACCP requirements.

    Conclusions	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-ofentry 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.

    Recommendations for Executive Action

    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-ofentry
    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:

    o 	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;

    o 	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;

    o 	give priority to taking enforcement actions when violations that pose
    the most serious public health risk occur;

    o 	consider the costs and benefits of implementing an accreditation
    program for private laboratories; and

    o 	explore the potential of implementing a certification program for
    thirdparty 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.

    Agency Comments and Our Evaluation

    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
    seafoodexporting 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.

    Lawrence J. Dyckman Director, Natural Resources

    and Environment

    Appendix I

    Scope and Methodology

    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,1 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 product2 during fiscal year 2002. The 96 inspections were
    associated with a total of 112 Forms 3502. 3

    1U.S. General Accounting Office, Food Safety: Federal Oversight of Seafood
    Does Not Sufficiently Protect Consumers, GAO-01-204 (Washington, D.C.:
    Jan. 31, 2001).

    2To record importer inspection findings, FDA investigators complete a
    product-specific standardized form (Form 3502) after each importer is
    inspected. The forms indicate whether importers have the required
    documentation, and if so, whether it documents the foreign firm's
    compliance with U.S. Hazard Analysis and Critical Control Point
    requirements. Investigators may choose to inspect documentation for more
    than one product and therefore complete more than one Form 3502 during an
    inspection.

    3We removed 5 inspections forms that were incorrectly completed.

    Appendix I
    Scope and Methodology

    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

    Appendix I
    Scope and Methodology

    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

    Appendix I
    Scope and Methodology

    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.

    Appendix II

    Summary of Expert Panel Observations on the Safety of Imported Seafood

    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.

    Members of Our Expert Panel

    The following individuals were members of our expert panel on the safety
    of imported seafood:

    o 	Haejung An, Associate Professor, Department of Nutrition and Food
    Science, Auburn University;

    o  Tom Chestnut, Vice President, Total Quality, Darden Restaurants;

    o 	Bob Collette, Vice President, Science and Technology, National
    Fisheries Institute;

    o 	Cameron Hackney, Dean, Davis College of Agriculture, Forestry and
    Consumer Sciences, West Virginia University;

    o 	Michael Jahncke, Director, Virginia Seafood Agricultural Research and
    Extension Center, Virginia Polytechnic Institute and State University;

    o 	Michael Moody, Professor and Head, Department of Food Science,
    Louisiana State University;

    o 	W. Steven Otwell, Professor, Seafood Technology, Department of Food
    Science and Human Nutrition, University of Florida;

    o 	Barbara Rasco, Associate Professor, Department of Food Science and
    Human Nutrition, Washington State University; and

    o 	Caroline Smith DeWaal, Director, Food Safety Approach, Center for
    Science in the Public Interest.

    Summary of Panel 	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

    Observations	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,

                                      Appendix II
                        Summary of Expert Panel Observations on
                             the Safety of Imported Seafood

    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.

    FDA's Recent Changes	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:

    o 	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.

    o 	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.

    o 	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.

    Options for Improving the Overall, panelists believed that FDA's approach
    to ensuring the safety of Current Regulatory imported seafood should
    address problems before products reach U.S. Approach ports of entry. They
    did not suggest providing FDA with more resources or

    eliminating any component of the agency's current approach (e.g.,
    port-ofentry examination and testing, foreign firm inspections, and
    importer inspections). However, the panelists did stress the need for FDA
    to

                                      Appendix II
                        Summary of Expert Panel Observations on
                             the Safety of Imported Seafood

    rearrange its approach, placing more responsibility for ensuring product
    safety on foreign governments, and to focus its available resources on
    ensuring that imported seafood is processed under effective HACCP systems.
    Therefore, the panelists recommended that FDA explore several options to
    enhance its regulatory approach, including the following:

    Equivalence Agreements  o 	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).

    o 	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.

    o 	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.

    o 	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

                                      Appendix II
                        Summary of Expert Panel Observations on
                             the Safety of Imported Seafood

    still implement third-party certification and auditing if equivalence is
    mandated.

    o 	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.

    Importer Inspections  o 	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.

    o 	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.

    Foreign Firm Inspections  o 	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.

    o 	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.

    o 	Panelists recommended that when problems are discovered as a result of
    inspections of foreign firms or importers, FDA should discuss with

                                      Appendix II
                        Summary of Expert Panel Observations on
                             the Safety of Imported Seafood

    the exporting countries how to prevent these problems from reoccurring.

    Port-of-entry Examinations and  o  Panelists suggested that state
    regulatory laboratories (e.g., those

    Testing

    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.

    o 	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.

    o 	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.

    Appendix III

    Results of GAO Analysis of FDA's Inspections of 99 Foreign Firms, Fiscal
    Year 2002

    Number of Firms inspections

                                       All firms

    With a HACCP plan as requireda

    Not required to have a HACCP plan

    Processing high-risk seafood

    Processing high-risk seafood with HACCP plansa

    Found to have serious violations by FDAa

    Placed on detention

                           Firms processing high-risk seafood

    With adequate HACCP plans

    With inadequate HACCP plansa

                      Firms found to have serious HACCP violations

    Issued a warning letter

    Issued an untitled letterb

    Source: GAO analysis of FDA's inspections of 99 foreign firms.

    Note: We received and reviewed 107 of the 108 foreign firm inspection
    records that FDA conducted in fiscal year 2002. Of the 107 files received,
    we removed 8 inspections because they covered shellfish, which was outside
    the scope of our assignment.

    aOne foreign processor did not have a HACCP plan as required.

    bOf the remaining 6 firms found to have serious HACCP violations, 1 firm
    no longer ships to the United States, 1 firm's case is still being
    reviewed, and 1 firm's warning letter was never issued; FDA is considering
    possible reinspection of this firm. For the remaining 3 firms, FDA
    officials said that they have no record of receiving the inspection
    reports.

    Appendix IV

    Comments from the Food and Drug Administration

    Note: GAO comments supplementing those in the report text appear at the
    end of this appendix.

    Appendix IV
    Comments from the Food and Drug
    Administration

                                     See comment 1.

                                     See comment 2.

                                     See comment 3.

    Appendix IV
    Comments from the Food and Drug
    Administration

                                     See comment 4.

    Appendix IV
    Comments from the Food and Drug
    Administration

    Appendix IV
    Comments from the Food and Drug
    Administration

                                     See comment 5.

    Appendix IV
    Comments from the Food and Drug
    Administration

    Appendix IV
    Comments from the Food and Drug
    Administration

                                     See comment 6.

    Appendix IV
    Comments from the Food and Drug
    Administration

    Appendix IV
    Comments from the Food and Drug
    Administration

                                      Appendix IV
                            Comments from the Food and Drug
                                     Administration

    The following are GAO's comments on the Food and Drug Administration's
    letter dated January 8, 2004.

    GAO Comments 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.1

    1Procedures for the safe and sanitary processing and importing of fish and
    fishery products, 60 Fed. Reg. 65096, 65155 (1995). (Codified at 21 CFR
    Pts. 123.12 and 1240.)

    Appendix IV
    Comments from the Food and Drug
    Administration

    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.

    Appendix V

    Comments from the National Oceanic and Atmospheric Administration

    Appendix VI

                         GAO Contacts and Staff Acknowledgments

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    Staff Acknowledgments

    (360298)

    In addition to the individuals named above, John C. Smith, Kenya Jones,
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    Katherine Raheb, Carol Herrnstadt Shulman, Sidney Schwartz, and Kathy
    Summers.

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