a

GAO

United States General Accounting Office

Report to Congressional Requesters

January 2004 FOOD SAFETY

FDA’s Imported 

Seafood Safety 

Program Shows Some 

Progress, but Further 

Improvements Are 

Needed

GAO-04-246
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. 

Highlights of GAO-04-246, a report to 

congressional requesters 

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. 

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. 
Page i GAO-04-246 Federal Oversight of Imported Seafood

Contents

Letter 1

Results in Brief 4

Background 7

FDA’s Imported Seafood Safety Program Shows Some Improvement, 

but Deficiencies Persist 13

Options Are Available for Enhancing FDA’s Imported Seafood Safety 

Program, but They Present Challenges 24

Conclusions 29

Recommendations for Executive Action 29

Agency Comments and Our Evaluation 30

Appendixes

Appendix I: Scope and Methodology 33

Appendix II: Summary of Expert Panel Observations on the Safety of 

Imported Seafood 37

Members of Our Expert Panel 37

Summary of Panel Observations 37

Appendix III: Results of GAO Analysis of FDA’s Inspections of 99 Foreign 

Firms, Fiscal Year 2002 42

Appendix IV: Comments from the Food and Drug Administration 43

GAO Comments 52

Appendix V: Comments from the National Oceanic and Atmospheric 

Administration 54

Appendix VI: GAO Contacts and Staff Acknowledgments 55

GAO Contacts 55

Staff Acknowledgments 55

Figures Figure 1: U.S. Seafood Consumption and Imports, 1993 to 2002 9

Figure 2: Percentage of Seafood Imports to the United States from 

Major Exporting Countries, 2002 10

Figure 3: Status of FDA’s Program Approaches for Ensuring the 

Safety of Imported Seafood, Fiscal Years 1999 and 

2002 14

Figure 4: Importers’ Regulatory and Compliance Requirements 15

Figure 5: Number of Days from Inspection to Issuance of Warning 

Letters for Serious Violations Found at 20 Foreign Firms, 

Fiscal Year 2002 22
Contents

Page ii GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 1 GAO-04-246 Federal Oversight of Imported Seafood

United States General Accounting Office

Washington, D.C. 20548

A

January 30, 2004 Letr

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.

1

According to the National Marine Fisheries Service, National Oceanic and Atmospheric 

Administration, the percentage of imported seafood is based on live weight. 

2

CDC 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. 
Page 2 GAO-04-246 Federal Oversight of Imported Seafood

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. 

3

Among 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.

4

The 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.
Page 3 GAO-04-246 Federal Oversight of Imported Seafood

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 

5

U.S. General Accounting Office, Food Safety: Federal Oversight of Seafood Does Not 

Sufficiently Protect Consumers, GAO-01-204 (Washington, D.C.: Jan. 31, 2001).
Page 4 GAO-04-246 Federal Oversight of Imported Seafood

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: 

• 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 
Page 5 GAO-04-246 Federal Oversight of Imported Seafood

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.

• 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.

• 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 
Page 6 GAO-04-246 Federal Oversight of Imported Seafood

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.

• 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. 

• 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. 

• 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. 
Page 7 GAO-04-246 Federal Oversight of Imported Seafood

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: 

• Biological hazards—include pathogens, such as Clostridium 

botulinum, Listeria monocytogenes, Salmonella species, and 

Staphylococcus aureus, and parasites such as roundworms and 

tapeworms. 

6

According 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.

7

Outbreaks 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). 
Page 8 GAO-04-246 Federal Oversight of Imported Seafood

• 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. 

• 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

8

FDA noted that a number of illnesses from ciguatoxin are from recreational versus 

commercial fishing, but the agency did not provide any specific data.

9

Consumption 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.
Page 9 GAO-04-246 Federal Oversight of Imported Seafood

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

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.

0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

Total consumption

Imports

Billions of pounds

Calendar year

Source: National Marine Fisheries Service, National Oceanic and Atmospheric Administration.
Page 10 GAO-04-246 Federal Oversight of Imported Seafood

Figure 2: Percentage of Seafood Imports to the United States from Major Exporting Countries, 2002

A large and rapidly growing proportion of worldwide seafood production, 

including U.S. imports, is produced by aquaculture. In 2000, aquaculture 

represented about 27 percent of global seafood production, and has 

increased by an average of 9.2 percent annually since 1970, compared with 

only an average 1.4 percent increase for captured seafood, according to the 

Food and Agriculture Organization of the United Nations. As in other 

animal production systems, aquaculture producers may use antibiotics and 

other chemicals to prevent or treat disease. Some producers have been 

found to misuse approved drugs or to use unapproved drugs or chemicals 

that pose potential human health hazards, such as antibiotic resistance, 

allergic reactions, or cancer. In recent years, food safety authorities in 

Europe, Canada, and the United States have begun to detect these 

substances and are taking steps to control their illegal use.

FDA is responsible for ensuring the safety of both domestic and imported 

seafood under the Federal Food, Drug, and Cosmetic Act. In 1997, 

Canada

China

Thailand

Chile

6% Ecuador

5% Vietnam

All others

18%

13%

13% 8%

37%

Source: GAO analysis of data from the National Marine Fisheries Service, National Oceanic and Atmospheric Administration.
Page 11 GAO-04-246 Federal Oversight of Imported Seafood

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: 

• Conduct a hazard analysis. Identify hazards that are reasonably likely 

to occur. 

• Identify the CCP. Identify a point, step, or procedure in the production 

process where controls can be applied to prevent, eliminate, or reduce 

to an acceptable level a food safety hazard that is reasonably likely to 

occur.

• Establish critical limits for each CCP. Set the maximum or minimum 

value at which parameters, such as cooking time and temperature, must 

be controlled at each CCP to prevent, eliminate, or reduce the hazard to 

an acceptable level.

• Monitor each CCP. Establish monitoring activities that will ensure that 

the process is under control at each CCP.

• Establish corrective actions. Define actions to be taken when 

monitoring discloses a deviation from established critical limits.

• Establish verification procedures. Establish verification procedures to 

ensure that HACCP plans accomplish their intended goal—that is, 

ensuring the production of safe products.

• Establish record-keeping and documentation procedures. Maintain 

documentation, including the HACCP plan; CCP monitoring; corrective 

actions; and verification activities.

Under the HACCP regulations, seafood-processing firms are responsible 

for conducting a hazard analysis and for developing and implementing 

HACCP plans for hazards that are determined to be reasonably likely to 

occur. These hazards may include marine toxins, microbiological 

contamination, chemical contamination, pesticides, drug residues, 
Page 12 GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 13 GAO-04-246 Federal Oversight of Imported Seafood

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).
Page 14 GAO-04-246 Federal Oversight of Imported Seafood

Figure 3: Status of FDA’s Program Approaches for Ensuring the Safety of Imported 

Seafood, Fiscal Years 1999 and 2002

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 

Program approaches Status

1. U.S. importers acquire seafood

from countries with equivalence

agreements.

2. U.S. importers document that foreign

suppliers comply with U.S. HACCP

requirements.

3. FDA conducts selected foreign firm

inspections to determine 

HACCP compliance.

4. FDA conducts selected port-of-entry

examinations and testing to determine 

if the seafood is misbranded or 

adulterated.

0

0

012345

48

27

0 10 20 30 40 50 60

1999

2002

1999

2002

1999

2002

1999

2002

1999

2002

Number of equivalence agreements

13

4

0 2 4 6 8 10 12 14

Number of foreign countries

107

37

0 20 40 60 80 100 120

Number of foreign firms

1.2

1

012345

Percentage of selected products tested

<

Percentage of products documented with

required HACCP compliance

Source: GAO analysis of FDA's seafood safety program.
Page 15 GAO-04-246 Federal Oversight of Imported Seafood

requirements for importers and the documentation that importers can use 

to demonstrate compliance.

Figure 4: Importers’ Regulatory and Compliance Requirements 

a

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

Regulations

require that importers meet one 

of two conditions (A or B)

Importers purchase seafood from countries 

that have equivalence agreements with FDA

Importers cannot use this option because 

there are no equivalence agreements

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

A

B

Source: FDA regulations.
Page 16 GAO-04-246 Federal Oversight of Imported Seafood

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. 
Page 17 GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 18 GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 19 GAO-04-246 Federal Oversight of Imported Seafood

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. 
Page 20 GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 21 GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 22 GAO-04-246 Federal Oversight of Imported Seafood

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

a

FDA’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.

0

2

8

2

5

3

0

1

2

3

4

5

6

7

8

9

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

Number of warning letters issued

Days from inspection to issuance

45a 226

Source: GAO analysis of FDA data.
Page 23 GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 24 GAO-04-246 Federal Oversight of Imported Seafood

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 

Personnel and Laboratories 

Could Augment FDA’s 

Regulatory Program 

NOAA officials said that they could assist FDA by providing various 

services to augment FDA’s regulatory program for imported seafood. These 

services include

• foreign firm inspections,

• HACCP training,
Page 25 GAO-04-246 Federal Oversight of Imported Seafood

• domestic importer inspections,

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

• assistance in developing and verifying equivalence or other types of 

agreements with seafood exporting countries. 

NOAA officials also said that they could conduct some domestic seafood 

inspection services that FDA currently conducts, which would allow FDA 

to refocus some of its resources on imported seafood. For example, NOAA 

inspectors could certify domestic seafood products shipped to the 

European Union and other countries, which is a service that NOAA 

provided in the past on a fee-for-service basis. Also, FDA and NOAA could 

agree to recognize NOAA’s current inspections of approximately 240 

domestic processing firms and authorize NOAA to inspect other domestic 

firms for compliance with HACCP. NOAA officials estimate that they could 

provide FDA with up to 22 full-time-equivalent field inspectors as well as 

additional technical support staff in its headquarters office. 

In addition, NOAA and FDA officials are now negotiating the terms of an 

agreement to use two NOAA laboratories to screen imported shrimp 

samples for the antibiotic chloramphenicol. FDA is taking this action to 

increase its testing capacity in response to the detection of the drug in 

imported shrimp by food safety authorities in Europe, Canada, and some 

U.S. states. Chloramphenicol is banned for use in food-producing animals 

because there is no known safe level for human ingestion of this substance. 

If the negotiations succeed, FDA would increase its screening capacity by 

400 samples per year.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. 
Page 26 GAO-04-246 Federal Oversight of Imported Seafood

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

• state laboratories are well equipped for food testing and provide reliable 

results,

• these laboratories have procedures in place that could meet FDA’s 

standards for compliance testing, and

• FDA’s use of state laboratories could improve coordination and 

information exchange regarding seafood-testing results between state 

laboratories and FDA. 

However, the panelists noted a disadvantage to using state regulatory 

laboratories. Many states are financially constrained and therefore may not 

have the excess capacity, equipment, time, or qualified analysts to assist 

FDA. Furthermore, if FDA were to consider using state laboratories to 

assist with port-of-entry testing, it would have to ensure that all 

laboratories are using appropriate sampling and testing methodology. 

While FDA laboratory officials agreed that using state regulatory 

laboratories could be beneficial, they expressed some concerns regarding 

using the laboratories to support FDA regulatory action. FDA officials 

agreed that state regulatory laboratories are likely to have established 
Page 27 GAO-04-246 Federal Oversight of Imported Seafood

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. 
Page 28 GAO-04-246 Federal Oversight of Imported Seafood

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. 
Page 29 GAO-04-246 Federal Oversight of Imported Seafood

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:

• 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;
Page 30 GAO-04-246 Federal Oversight of Imported Seafood

• develop and implement a system to track the time involved in 

documenting, reviewing, and processing regulatory and enforcement 

actions, such as issuing warning letters and detaining unsafe products, 

so that FDA can identify the reasons for the delays and take actions to 

address them;

• give priority to taking enforcement actions when violations that pose 

the most serious public health risk occur;

• consider the costs and benefits of implementing an accreditation 

program for private laboratories; and 

• explore the potential of implementing a certification program for 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 
Page 31 GAO-04-246 Federal Oversight of Imported Seafood

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. 
Page 32 GAO-04-246 Federal Oversight of Imported Seafood

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
Page 33 GAO-04-246 Federal Oversight of Imported Seafood

Appendix I

Scope and Methodology AAppenednxidexiIs

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

1

U.S. General Accounting Office, Food Safety: Federal Oversight of Seafood Does Not 

Sufficiently Protect Consumers, GAO-01-204 (Washington, D.C.: Jan. 31, 2001).

2

To 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.

3

We removed 5 inspections forms that were incorrectly completed.
Appendix I

Scope and Methodology

Page 34 GAO-04-246 Federal Oversight of Imported Seafood

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

Page 35 GAO-04-246 Federal Oversight of Imported Seafood

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

Page 36 GAO-04-246 Federal Oversight of Imported Seafood

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.
Page 37 GAO-04-246 Federal Oversight of Imported Seafood

Appendix II

Summary of Expert Panel Observations on the 

Safety of Imported Seafood ApendxiI

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:

• Haejung An, Associate Professor, Department of Nutrition and Food 

Science, Auburn University;

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

• Bob Collette, Vice President, Science and Technology, National 

Fisheries Institute;

• Cameron Hackney, Dean, Davis College of Agriculture, Forestry and 

Consumer Sciences, West Virginia University;

• Michael Jahncke, Director, Virginia Seafood Agricultural Research and 

Extension Center, Virginia Polytechnic Institute and State University;

• Michael Moody, Professor and Head, Department of Food Science, 

Louisiana State University;

• W. Steven Otwell, Professor, Seafood Technology, Department of Food 

Science and Human Nutrition, University of Florida;

• Barbara Rasco, Associate Professor, Department of Food Science and 

Human Nutrition, Washington State University; and

• Caroline Smith DeWaal, Director, Food Safety Approach, Center for 

Science in the Public Interest.

Summary of Panel 

Observations

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, 
Appendix II

Summary of Expert Panel Observations on 

the Safety of Imported Seafood

Page 38 GAO-04-246 Federal Oversight 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: 

• Panelists suggested that inspecting a small number of foreign firms for 

HACCP compliance, rather than inspecting foreign countries’ entire 

food safety systems for equivalence, is ineffective because FDA only 

inspects about 100 seafood firms in 10 countries annually, out of a 

universe of an estimated 13,000 firms in about 160 countries. 

• Panelists believed that increasing the number of port-of-entry 

examinations and laboratory testing for imported seafood, while 

desirable, would be ineffective because this approach is not consistent 

with the preventative HACCP approach. 

• Because regulatory authorities around the world are increasingly 

finding aquaculture drug residues, the panelists believed that more 

testing for drug residues would be a valuable verification step in an 

effective HACCP system. Furthermore, panelists believed that FDA 

should shift its focus to the source of production to prevent the abuse of 

legal substances or the use of banned aquaculture drugs. 

Options for Improving the 

Current Regulatory 

Approach

Overall, panelists believed that FDA’s approach to ensuring the safety of 

imported seafood should address problems before products reach U.S. 

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

Page 39 GAO-04-246 Federal Oversight 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 • Panelists recommended that FDA establish equivalence agreements in 

order to more efficiently utilize its limited resources. They believed that 

equivalence agreements would be more effective than FDA’s direct 

inspection of foreign firms for ensuring HACCP compliance and would 

also allow the agency to focus resources on the countries, firms, and 

products that pose the greatest risk, thereby shifting the burden for 

HACCP compliance from FDA to foreign governments and foreign firms. 

Panelists stated that such agreements should not imply that FDA must 

find a foreign government’s seafood safety system “equal” to that of the 

U.S. system. For example, panelists said that FDA should have flexibility 

in terms of what it considers equivalent and should also consider 

alternatives to country-to-country agreements (e.g., product-to-country, 

company-to-country, and hazard-specific agreements). 

• The panel recommended that FDA first consider one-way equivalence 

agreements, with counties where the United States imports large 

quantities of seafood but does not export significant quantities. 

Although panelists noted that two-way agreements are preferred, they 

believed that using one-way equivalence agreements initially would 

better ensure that foreign firms are meeting U.S. standards. However, 

U.S. seafood exporters may object to one-way agreements, arguing that 

these would favor the foreign countries, which may have barriers to U.S. 

exports. 

• Panelists recommended that FDA establish a timeline for agreements, 

although there was no consensus on the best way to develop this 

timeline. Possible suggestions included a phased-in process, based on 

the quantity of exports to the United States, and the establishment of 

agreements based on the willingness of participants.

• Panelists believed that Congress should mandate that FDA establish 

equivalence agreements; however, FDA should be allowed to determine 

how the agreements are structured and implemented. The panel also 

expressed concern that our trading partners could view mandating 

equivalence as protectionist. Additionally, panelists said FDA should 
Appendix II

Summary of Expert Panel Observations on 

the Safety of Imported Seafood

Page 40 GAO-04-246 Federal Oversight of Imported Seafood

still implement third-party certification and auditing if equivalence is 

mandated.

• The panel believed that FDA should provide additional training and 

education to foreign governments and foreign firms on HACCP 

requirements, and that industry should pay for this training.

Importer Inspections • Panelists recommended that FDA identify competent inspection 

authorities to establish lists of preferred suppliers, in which the foreign 

government inspects firms wishing to export to the United States, to 

assure the agency that these firms meet HACCP requirements. By 

adopting this approach, FDA could then target inspection and testing 

resources to nonpreferred suppliers.

• Panelists recommended that FDA develop an accreditation program for 

private laboratories that demonstrate compliance with FDA’s testing 

methodologies. FDA could then establish a list of approved, accredited 

domestic laboratories to augment their port-of-entry testing for 

compliance and enforcement. Additionally, domestic importers could 

use the accredited foreign and domestic laboratories to demonstrate, 

through testing, that their seafood products were processed in 

accordance with HACCP requirements. Panelists believed that most 

domestic private laboratories are capable of meeting FDA’s standards, 

such as sample chain-of-custody, laboratory procedure, and qualified 

analysts, and could provide timely results. 

Foreign Firm Inspections • Panelists recommended that FDA establish a standardized program to 

certify private, third-party inspectors to conduct HACCP inspections of 

foreign processing firms and domestic importers. The third-party 

inspectors would be paid for by industry and monitored by FDA, thereby 

allowing for more foreign firm and importer inspections at little 

additional cost to FDA.

• Panelists recommended that FDA place more responsibility on foreign 

governments to ensure that foreign firms are aware of, and are meeting, 

their responsibilities under HACCP. Under an effective HACCP system, 

the panelists felt that FDA’s emphasis should be on inspection and 

testing in the foreign country where the seafood is harvested and 

processed and where hazards are introduced.

• Panelists recommended that when problems are discovered as a result 

of inspections of foreign firms or importers, FDA should discuss with 
Appendix II

Summary of Expert Panel Observations on 

the Safety of Imported Seafood

Page 41 GAO-04-246 Federal Oversight of Imported Seafood

the exporting countries how to prevent these problems from 

reoccurring. 

Port-of-entry Examinations and 

Testing

• Panelists suggested that state regulatory laboratories (e.g., those 

operated by the state Department of Health or Agriculture) may be a 

good option for assisting FDA in testing imported seafood products, 

particularly in those states with ports and seafood industries. State 

laboratories provide comparable testing for state regulatory authorities 

and have procedures in place that could meet FDA’s standards for 

compliance testing. State laboratories are also well equipped for food 

testing and provide reliable results. Panelists did note, however, that 

most states are financially constrained, and therefore state laboratories 

may not have any excess capacity (e.g., qualified analysts, equipment 

time, or laboratory space) to analyze additional samples for FDA. 

Furthermore, in order to use the facilities, FDA would need to 

harmonize testing methodologies. 

• Panelists suggested that FDA use the National Marine Fisheries Service 

laboratories in Pascagoula, Mississippi, and Seattle, Washington, to 

augment testing at ports of entry. Panel members believed that this was 

a good option for FDA because these laboratories currently conduct 

seafood research and testing. 

• Panelists did not recommend that FDA use academic laboratories for 

testing at ports of entry. They stated that most academic laboratories are 

not structured to do compliance testing and would not meet FDA’s 

standards for chain of custody of the samples or acceptable 

documentation for compliance or enforcement actions. 
Page 42 GAO-04-246 Federal Oversight of Imported Seafood

Appendix III

Results of GAO Analysis of FDA’s Inspections 

of 99 Foreign Firms, Fiscal Year 2002 ApendxiI

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.

a

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

b

Of 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. 

Firms

Number of 

inspections

All firms

With a HACCP plan as requireda 93

Not required to have a HACCP plan 5

Processing high-risk seafood 66

Processing high-risk seafood with HACCP plansa 65

Found to have serious violations by FDAa 40

Placed on detention 6

Firms processing high-risk seafood

With adequate HACCP plans 10

With inadequate HACCP plansa 55

Firms found to have serious HACCP violations

Issued a warning letter 20

Issued an untitled letterb 14
Page 43 GAO-04-246 Federal Oversight of Imported Seafood

Appendix IV

Comments from the Food and Drug 

Administration ApendxiIV

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

Page 44 GAO-04-246 Federal Oversight of Imported Seafood

See comment 1.

See comment 2.

See comment 3.
Appendix IV

Comments from the Food and Drug 

Administration

Page 45 GAO-04-246 Federal Oversight of Imported Seafood

See comment 4.
Appendix IV

Comments from the Food and Drug 

Administration

Page 46 GAO-04-246 Federal Oversight of Imported Seafood
Appendix IV

Comments from the Food and Drug 

Administration

Page 47 GAO-04-246 Federal Oversight of Imported Seafood

See comment 5.
Appendix IV

Comments from the Food and Drug 

Administration

Page 48 GAO-04-246 Federal Oversight of Imported Seafood
Appendix IV

Comments from the Food and Drug 

Administration

Page 49 GAO-04-246 Federal Oversight of Imported Seafood

See comment 6.
Appendix IV

Comments from the Food and Drug 

Administration

Page 50 GAO-04-246 Federal Oversight of Imported Seafood
Appendix IV

Comments from the Food and Drug 

Administration

Page 51 GAO-04-246 Federal Oversight of Imported Seafood
Appendix IV

Comments from the Food and Drug 

Administration

Page 52 GAO-04-246 Federal Oversight of Imported Seafood

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

 

1

Procedures 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

Page 53 GAO-04-246 Federal Oversight of Imported Seafood

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. 
Page 54 GAO-04-246 Federal Oversight of Imported Seafood

Appendix V

Comments from the National Oceanic and 

Atmospheric Administration ApendxiV
Page 55 GAO-04-246 Federal Oversight of Imported Seafood

Appendix VI

GAO Contacts and Staff Acknowledgments ApendxiVI

GAO Contacts Lawrence J. Dyckman, (202) 512-3841

Maria Cristina Gobin, (202) 512-6526

Staff 

Acknowledgments 

In addition to the individuals named above, John C. Smith, Kenya Jones, 

and Lisa Vojta made key contributions. Other contributors included, Aldo 

Benejam, Oliver Easterwood, Lynn Musser, Cynthia Norris, Paul Pansini, 

Katherine Raheb, Carol Herrnstadt Shulman, Sidney Schwartz, and Kathy 

Summers.

(360298)
GAO’s Mission The General Accounting Office, the audit, evaluation and investigative arm of 

Congress, exists to support Congress in meeting its constitutional responsibilities 

and to help improve the performance and accountability of the federal government 

for the American people. GAO examines the use of public funds; evaluates federal 

programs and policies; and provides analyses, recommendations, and other 

assistance to help Congress make informed oversight, policy, and funding 

decisions. GAO’s commitment to good government is reflected in its core values of 

accountability, integrity, and reliability.

Obtaining Copies of 

GAO Reports and 

Testimony

The fastest and easiest way to obtain copies of GAO documents at no cost is 

through the Internet. GAO’s Web site (www.gao.gov) contains abstracts and fulltext files of current reports and testimony and an expanding archive of older 

products. The Web site features a search engine to help you locate documents 

using key words and phrases. You can print these documents in their entirety, 

including charts and other graphics.

Each day, GAO issues a list of newly released reports, testimony, and 

correspondence. GAO posts this list, known as “Today’s Reports,” on its Web site 

daily. The list contains links to the full-text document files. To have GAO e-mail this 

list to you every afternoon, go to www.gao.gov and select “Subscribe to 

e-mail alerts” under the “Order GAO Products” heading.

Order by Mail or Phone The first copy of each printed report is free. Additional copies are $2 each. A check 

or money order should be made out to the Superintendent of Documents. GAO 

also accepts VISA and Mastercard. Orders for 100 or more copies mailed to a single 

address are discounted 25 percent. Orders should be sent to:

U.S. General Accounting Office

441 G Street NW, Room LM

Washington, D.C. 20548

To order by Phone: Voice: (202) 512-6000 

TDD: (202) 512-2537 

Fax: (202) 512-6061

To Report Fraud, 

Waste, and Abuse in 

Federal Programs

Contact:

Web site: www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470

Public Affairs Jeff Nelligan, Managing Director, NelliganJ@gao.gov (202) 512-4800

U.S. General Accounting Office, 441 G Street NW, Room 7149 

Washington, D.C. 20548
United States

General Accounting Office

Washington, D.C. 20548-0001

Official Business

Penalty for Private Use $300

Address Service Requested

Presorted Standard

Postage & Fees Paid

GAO

Permit No. GI00