GAO

United States General Accounting Office

Report to the Committee on Agriculture, 

Nutrition, and Forestry, U.S. Senate

January 2001 FOOD SAFETY

Federal Oversight of 

Seafood Does Not 

Sufficiently Protect 

Consumers

GAO-01-204

Page 1 GAO-01-204 Federal Oversight of Seafood

Contents

Letter 3

Appendixes Appendix I: Scope and Methodology 38

Appendix II: Seafood-Related Illnesses 42

Appendix III: Seafood Safety Programs in the United States, 

Canada, and Chile 43

Appendix IV: Comments From the Food and Drug Administration 46

Appendix V: GAO Contacts and Staff Acknowledgments 60

Tables Table 1: Estimated Percentage of Occurrences of Nine Types 

of Serious HACCP Violations in Fiscal Year 1999 Inspection 

Records for Three FDA Districts 19

Table 2: Problems Found During Inspections in Four Exporting

Countries, Fiscal Year 1999 30

Table 3: Sampling Plan for Three FDA Districts, Fiscal Year 1999 39

Table 4: Sampling Errors for Selected Estimates for Three District

Offices, Fiscal Year 1999 40

Table 5: Sampling Errors for Selected Subgroups for Three District

Offices, Fiscal Year 1999 40

Table 6: Selected Illnesses Caused by Seafood and Seafood Products 42

Table 7: Characteristics of the Seafood Safety Program in the United 

States, Canada, and Chile 43

Figures Figure 1: Percentage of 1999 U.S. Seafood Imports from Major

Exporting Countries 9

Figure 2: Importers’ Regulatory and Compliance Requirements 27
Contents

Page 2 GAO-01-204 Federal Oversight of Seafood

Abbreviations

CDC Centers for Disease Control and Prevention

CCP critical control point

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

GAO General Accounting Office

HAACP Hazard Analysis and Critical Contro Point (system)

QMP Quality Management Program

USDA U.S. Department of Agriculture
Page 3 GAO-01-204 Federal Oversight of Seafood

United States General Accounting Office

Washington, D.C. 20548 Letr

January 31, 2001

The Honorable Richard G. Lugar

Chairman

The Honorable Tom Harkin

Ranking Member

Committee on Agriculture, Nutrition, and Forestry

United States Senate

Contaminated food products cause an estimated 76 million foodborne 

illnesses annually in the United States, according to the Centers for Disease 

Control and Prevention (CDC). Seafood (finfish and crustaceans) 

represented about 15 percent of the documented foodborne illness 

outbreaks in the United States,1

 according to CDC’s data for 1997, the latest 

year for which such data are available. Seafood-related illnesses could 

result in a variety of problems, ranging from mild gastrointestinal 

discomfort to neurological damage or death.

Recognizing the potential for foodborne illness posed by seafood, the Food 

and Drug Administration (FDA) implemented a new science-based seafood 

safety program in 1997—the Hazard Analysis and Critical Control Point 

(HACCP) system. The U.S. Department of Agriculture (USDA) also adopted 

a HACCP system for meat and poultry products.2

 HACCP systems are 

designed to improve the safety of food by having industry identify and 

control known microbiological, physical, and chemical hazards in products 

before they enter the market. FDA’s HACCP regulations require that 

domestic seafood-processing firms conduct an analysis to identify hazards 

that are reasonably likely to occur and to develop and implement a plan to 

control them.3

 In addition, the HACCP regulations require seafoodprocessing firms to implement a written sanitation-operating procedure to, 

among other things, avoid spreading contamination from one work surface 

to another, control employee health conditions, and control pests. FDA 

1

Molluscan shellfish—oysters, clams, mussels, and whole or roe-on scallops—are discussed 

in a separate report. 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.

2

USDA is responsible for the safety of meat, poultry, and some egg products while FDA is 

responsible for the safety of all other foods.

3

21 C.F.R. part 123. Processing firms subject to HACCP requirements include those that 

handle, store, prepare, head, eviscerate, and freeze seafood products.
Page 4 GAO-01-204 Federal Oversight of Seafood

inspects seafood-processing firms to verify their compliance with these 

HACCP requirements. Some state regulatory authorities also conduct 

HACCP verification inspections under contract or in partnership with FDA.

Imported seafood—which constitutes more than one-half of all the seafood 

consumed in the United States—must meet these requirements as well. 

That is, U.S. importers are required to demonstrate that seafood products 

from foreign countries are produced in accordance with HACCP 

regulations for U.S. seafood. The easiest way for importers to meet HACCP 

responsibilities and requirements is to obtain seafood from foreign firms in 

countries having an agreement with FDA that documents the equivalent 

seafood safety systems. Currently, FDA has not completed any agreements 

for seafood; therefore, importers are required to take affirmative steps to 

demonstrate that seafood products from foreign countries are produced in 

accordance with regulations for U.S. seafood. Such affirmative steps 

include, for example, maintaining a copy of the foreign firms’ HACCP plan 

on file or obtaining a certificate from a foreign government’s appropriate 

inspection authority. FDA also inspects some foreign seafood firms as well 

as U.S. importers to determine their compliance with FDA’s HACCP 

regulations and some imported seafood products at the U.S. port of entry to 

verify their safety. 

In response to your request, we evaluated the effectiveness of FDA’s system 

to control the risk of foodborne illness resulting from unsafe domestic and 

imported seafood. To conduct this review, we visited the three FDA 

districts in which the largest volumes of seafood are produced—Seattle, 

New England, and Florida—to analyze the results of FDA’s inspections, to 

conduct a probability sample of FDA’s inspection reports,4

 and to interview 

FDA and industry personnel. We also reviewed selected aspects of the 

seafood programs of Chile and Canada because these countries are large 

exporters of seafood products to the United States and they have 

implemented HACCP systems. In addition, we reviewed the status of 

pending seafood equivalence agreements, FDA’s inspection reports of 

foreign seafood firms, the results of FDA’s seafood inspections of U.S. 

importers, and seafood examinations at ports of entry. Appendix I provides 

additional details on our scope and methodology.

4

See appendix 1 for a description of the sample and the sampling errors associated with the 

estimates based on this sample.
Page 5 GAO-01-204 Federal Oversight of Seafood

Results in Brief FDA has made some progress in ensuring the safety of seafood consumed 

by the public. In 1997, the agency implemented the HACCP system and 

inspected all seafood-processing firms in its inventory at least once to 

verify that firms were, in fact, implementing the HACCP requirements. 

According to FDA’s December 2000 report on the HACCP system for 

seafood,5 the percentage of seafood firms with a HACCP plan that included 

all of the required components increased from 31 percent in 1998 to 44 

percent in 1999. However, FDA recognizes that there are still gaps in 

HACCP’s implementation and that certain segments of the industry are 

lagging behind. Our evaluation of FDA’s seafood safety program identified a 

number of weaknesses in FDA’s domestic and imported seafood programs. 

With regard to domestic seafood, we found that four program weaknesses 

limit FDA’s ability to prevent unsafe seafood from reaching consumers. 

First, although FDA’s HACCP regulations apply to all seafood-processing 

firms, for a variety of reasons, a significant number of seafood products are 

not being processed under HACCP systems, including those processed on 

board fishing vessels. For example, FDA’s inventory of seafood-processing 

firms includes only 250 vessels that are subject to HACCP requirements. 

The actual number of fishing vessels that should be under HACCP 

requirements is not known because neither FDA nor any other organization 

we contacted currently collects such data. However, an official in one FDA 

district office noted that from 400 to 800 fishing vessels in his district may 

perform some type of processing on board. Second, even when seafood 

products have been processed under a HACCP system, there are serious 

weaknesses. For example, we estimate that in the three districts we 

studied, about 48 percent of the seafood products subject to HACCP 

requirements and selected for examination were not being processed at the 

time of FDA’s inspections. As a result, the inspections for these products 

were limited to a paperwork review, and as a general rule, inspectors did 

not return to inspect the product as required by FDA’s compliance manual. 

Furthermore, over half of the inspections identified serious violations, such 

as the failure to identify likely hazards. Third, even when inspectors 

identified significant violations, FDA did not issue warning letters—one of 

the agency’s principal means of notifying regulated firms of serious 

violations—in a timely manner. In calendar year 2000, 94 percent of the 

warning letters exceeded the 15-day review and approval time frame 

recommended in FDA’s Regulatory Procedures Manual. The warning letters 

5

Evaluation of FDA’s Hazard Analysis Critical Control Point (HACCP) Program for Seafood 

for Calendar Years 1998 and 1999 (Dec. 8, 2000).
Page 6 GAO-01-204 Federal Oversight of Seafood

took an average of 73 days to approve. Fourth, while USDA has objective, 

quantifiable data to assess the effectiveness of its HACCP system for meat 

and poultry, FDA does not for seafood. FDA acknowledges some of these 

problems. However, while Congress increased FDA’s funding by $32 million 

from fiscal year 1999 through fiscal 2000 for its food programs, FDA 

believes it needs additional resources to resolve these problems.

FDA’s regulation of imported seafood also provides insufficient assurance 

that the products are safe. FDA’s system for ensuring the safety of imported 

seafood is based on four basic strategies—equivalence or compliance 

agreements, reviews of importers’ records, inspections of selected foreign 

firms, and port of entry product examinations. We identified difficulties in 

the implementation of each of these strategies. First, according to FDA 

officials, the easiest way to ensure that imported seafood is processed 

under an acceptable HACCP system is for importers to purchase products 

from countries with which FDA has an equivalence or compliance 

agreement. However, FDA has so far been unable to complete seafood 

equivalence or compliance agreements with any country. Second, in the 

absence of such agreements, U.S. importers must have records from their 

foreign customers showing that the products offered for entry into the 

United States have been processed under HACCP requirements. However, 

we found that less than one-third of the importers that FDA inspected had 

the required documentation to demonstrate compliance with the HACCP 

requirements. Third, FDA’s inspections of selected foreign seafood firms 

often identified serious problems, such as the absence of HACCP plans, but 

FDA has not followed-up with an automatic examination of these firms’ 

products at U.S. ports of entry. Fourth, FDA’s last strategy for ensuring the 

safety of imported seafood—port of entry examinations and product 

testing—has been widely discredited as an effective approach to ensuring 

the safety of imported products, and as we previously reported,6

 such 

inspections are labor-intensive. In addition, FDA is unable to keep pace 

with the growing levels of imported foods. For example, in 1999, FDA 

tested less than 1 percent of all seafood imported into the United States. 

FDA acknowledges some of the limitations of its imported seafood safety 

system but states that reaching equivalence or compliance agreements with 

other countries takes considerable time and resources.

6

See Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent 

and Unreliable (GAO/RCED-98-103, Apr. 30, 1998).
Page 7 GAO-01-204 Federal Oversight of Seafood

We are providing the Congress with two matters for consideration and 

making several recommendations to the Commissioner of FDA aimed at (1) 

achieving stronger implementation of the HACCP system for seafood and 

(2) providing greater assurances to the public that both domestic and 

imported seafood products are safe. In commenting on a draft of this 

report, FDA essentially concurred with six of our recommendations to the 

agency and disagreed with two. FDA disagreed with our recommendation 

that all seafood-processing firms, including vessels, operate under HACCP 

requirements and that FDA develop goals and time frames for establishing 

equivalence agreements. We continue to believe that these two 

recommendations have merit.

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.7

 For 

example, seafood products represented about 15 percent, or 26, of the 169 

foodborne illness outbreaks with a confirmed source—a level greater than 

that associated with meat and poultry products, which are consumed at, 

respectively, 8 and 6 times the rate of seafood. However, CDC officials said 

that foodborne illness outbreaks are generally underreported and that it is 

easier to identify the source of some diagnosable illnesses, such as 

scombroid poisoning from seafood, than illnesses resulting from some 

nonspecific gastrointestinal symptoms caused by other foods. FDA also 

noted that some seafood-related illnesses may be caused by fish caught 

recreationally. The actual number of individual cases of illness resulting 

from traced outbreaks were higher for meat and poultry (619 and 353 

cases, respectively) compared with 108 cases for seafood. Seafood 

outbreaks may have involved fewer individual cases of illness because 

seafood has much lower consumption rates than meat and poultry.

7

According to CDC, only a fraction of foodborne illnesses are routinely reported, and since 

most foodborne illnesses are sporadic, only a small number are identified as being part of an 

outbreak.
Page 8 GAO-01-204 Federal Oversight of Seafood

Biological, chemical, and physical hazards can cause seafood-related 

illnesses. Biological hazards include clostridium botulinum, listeria 

monocytogenes, salmonella, and pathogenic staphylococcus. Chemical 

hazards include compounds such as methylmercury, which can cause 

illness from long-term exposure. Physical hazards include foreign objects 

in food that can cause harm when eaten, such as glass or metal fragments. 

According to FDA officials, two naturally occurring marine toxins with 

potentially serious health effects—scombrotoxin and ciguatoxin8

—cause 

most reported seafood-related illnesses, including gastrointestinal and 

neurological problems. These naturally occurring toxins are biological in 

origin but are categorized as chemical hazards, are heat resistant, and 

cannot be inactivated by cooking. Appendix II provides additional 

information on seafood-related illnesses and their symptoms.

Since 1980, seafood consumption in the United States has risen about 22 

percent, from 12.5 pounds per person in 1980 to 15.3 pounds per person in 

1999. According to data from the National Marine Fisheries Service, the 

United States imported about 3.9 billion pounds of fishery products during 

1999 from about 160 countries. The top five seafood-exporting countries—

Canada, Thailand, China, Ecuador, and Chile—accounted for 50 percent of 

the volume of imported seafood. Imported products include fresh and 

frozen tuna and salmon as well as crustaceans, such as shrimp and 

lobsters. Figure 1 shows the proportion of U.S. seafood imports from five 

leading exporting countries. 

8

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

commercial fishing but did not provide any specific data.
Page 9 GAO-01-204 Federal Oversight of Seafood

Figure 1: Percentage of 1999 U.S. Seafood Imports from Major Exporting Countries 

a

Comprises imported seafood from about 160 countries.

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

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

seafood under the Federal Food, Drug, and Cosmetic Act (FFDCA). In 

1997, following recommendations by the National Academy of Sciences 

and others, FDA adopted a program of preventive controls designed to 

identify hazards early in the seafood-production process and minimize the 

risk of contamination. The HACCP regulations made seafood-processing 

firms responsible for identifying harmful microbiological, chemical, and 

physical hazards that are reasonably likely to occur and for establishing 

critical control points to prevent or reduce contamination. The HACCP 

system is based on seven principles that each seafood firm must address. 

50% • Othera 

17%•

Canada 

15%•

Thailand 

•

8%

China 

•

6%

Ecuador 

•

4%

Chile 

By volume
Page 10 GAO-01-204 Federal Oversight of Seafood

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

occur. 

• Identify the critical control points (CCPs). Identify a point, step, or 

procedure in the production process where controls can be applied to 

prevent, eliminate, or reduce a food safety hazard that is reasonably 

likely to occur to an acceptable level.

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

value at which a hazard must be controlled at each CCP to prevent, 

eliminate, or reduce the hazard to an acceptable level.

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

the process is under control at each CCP.

• Establish corrective actions. Define actions to be taken when 

monitoring discloses a deviation from established critical limits.

• Establish verification procedures. Establish verification procedures to 

ensure that HACCP plans accomplish their intended goal—ensuring the 

production of safe products.

• Establish record-keeping and documentation procedures. Maintain 

documentation, including the HACCP plan, CCP monitoring, critical 

limits, and verification activities.

Under the HACCP rule, seafood-processing firms are responsible for 

conducting a hazard analysis and for developing and implementing HACCP 

plans for hazards determined to be reasonably likely to occur: natural 

toxins, microbiological contamination, chemical contamination, pesticides, 

drug residues, decomposition in certain species, parasites, unapproved use 

of food or color additives, and physical hazards. For each hazard identified, 

the firms must establish critical control points to prevent or reduce 

contamination. Firms must also establish and monitor sanitation 

procedures to ensure, among other things, the (1) general cleanliness of 

food contact surfaces, including utensils, gloves, and outer garments, and 

(2) control of employee health conditions.

To assist industry with HACCP compliance, FDA published the Fish and 

Fisheries Products Hazards and Controls Guide, which discusses, among 

other things, how to perform a hazard analysis, develop a HACCP plan, and 

identify critical control points. The guide provides species-specific and 

process-related examples of hazards reasonably likely to occur, but as its 

name suggests, this document is only guidance; seafood firms are not 

required to follow it. The guide, according to FDA, has been translated into 

other languages, is used by regulatory authorities in other countries, and 

has served as a catalyst for discussions between the seafood industry, other 
Page 11 GAO-01-204 Federal Oversight of Seafood

interested stakeholders, and FDA about the scientific merits of hazards and 

controls.

According to the National Fisheries Institute,9

 seafood firms generally 

support the HACCP system because it has, among other things, caused the 

industry to look at how best to manage hazards and how to look at food 

safety from a science-based perspective—for example, what hazards are 

likely to cause illness, how frequently people are becoming ill, and how 

serious those illnesses are. Also, according to FDA, two surveys of the 

industry taken by the New York Sea Grant Extension program and others 

report that in response to HACCP, the industry is engaging in upgrades to 

facilities, equipment, and daily plant operations to ensure safety. 

To help implement and oversee HACCP systems, for industry personnel 

and FDA inspectors, FDA developed a training and certification program 

that is intended to ensure that they have the necessary expertise to 

evaluate HACCP systems. The training program is offered by the National 

Seafood HACCP Alliance—an academic, government, and industry 

consortium. The Alliance’s course is the standardized curriculum by which 

FDA evaluates other HACCP courses; it contains the information necessary 

to meet the HACCP-training requirements. Course participants receive a 

certificate. The seafood HACCP regulations require that industry personnel 

responsible for developing HACCP plans, reassessing and modifying the 

plan, and performing record reviews successfully complete training in the 

application of HACCP principles for fish and fishery products at least 

equivalent to those received under the FDA-approved course. However, the 

regulations also state that job experience will qualify an individual to 

perform these functions if he or she has provided knowledge at least 

equivalent to that provided through the standardized curriculum. 

FDA periodically inspects seafood firms to check on their sanitary 

conditions and to verify compliance with the HACCP requirements. To 

determine whether seafood firms identify all safety hazards and whether 

they are consistently controlling those hazards, FDA inspectors survey the 

plant and then review the HACCP records. From 1998 through 1999, FDA 

inspected all seafood firms in its inventory at least once to verify 

compliance with the new HACCP-based system. In the budget for fiscal 

year 2000, Congress provided $267 million for FDA’s food programs—a $32 

9

The National Fisheries Institute advocates the interests of the seafood industry in Congress 

and before regulatory agencies. 
Page 12 GAO-01-204 Federal Oversight of Seafood

million increase over FDA’s budget for fiscal year 1999. Some of this 

increase was to enhance the coverage of both domestic and imported 

foods, including the increased inspection of high-risk food and continued 

implementation of the HACCP requirement for seafood. While FDA 

believes that additional funds are needed to ensure the safety of the food 

supply, it now inspects seafood firms annually. Prior to these annual 

inspections, FDA inspected seafood firms once every 4 years on average, 

according to FDA officials. 

Generally, FDA personnel inspect one or two seafood products at each firm 

inspected. The number of seafood products handled by each firm varies. 

According to FDA, seafood-processing firms collectively handle over 350 

species of fish. For example, the seafood firms that we visited in Norfolk 

and Philadelphia processed a wide range of products, including fresh and 

frozen fish, such as salmon, tuna, bluefish, mahi-mahi, mackerel, and 

grouper; crustaceans, such as lobster and crabs; and shellfish, such as 

oysters and clams. FDA’s policy was to give priority to inspecting products 

considered to be high-risk, including

• vacuumed-packaged seafood (these products are subject to the growth 

of Clostridium botulinum, a toxin producing bacteria);

• ready-to-eat seafood, such as cooked shrimp and crabmeat and hot or 

cold smoked fish (these products are subject to the growth of pathogens 

from post-process contamination);

• histamine-forming species, including mahi-mahi, tuna, and bluefish 

(these products are subject to histamine formation—a toxic substance); 

and

• stuffed seafood products (processing and handling may allow toxins to 

develop in these products).

FDA can take several regulatory actions when firms are cited for HACCP 

violations. For example, if in the agency’s judgment the violation cited is of 

regulatory significance, it may issue the firm a warning letter. FDA issues 

warning letters in cases where violations raise safety concerns that may 

lead to enforcement action, such as product seizure or injunction (a court 

order to refrain from distributing a product), and/or prosecution if not 

promptly and adequately corrected. In the case of importers, a warning 

letter could advise them of a forthcoming detention. Firms that receive 

warning letters are asked to respond to FDA in writing within 15 working 

days to indicate what actions will be taken to correct the problems 

identified. If the firm does not correct the violation promptly and 
Page 13 GAO-01-204 Federal Oversight of Seafood

adequately, FDA can pursue enforcement actions, such as product seizure 

or injunction through the courts. 

In 1996, USDA issued HACCP regulations for meat and poultry firms. 

However, before implementing HACCP, USDA established the prevalence, 

or baseline, levels for a number of microbial organisms in meat and poultry, 

including salmonella, E-coli, listeria, and campylobacter. These baseline 

data provided USDA with a starting point for evaluating the effectiveness of 

HACCP in terms of lowering the bacterial levels in the product. For 

example, USDA regularly collects and tests samples of meat and poultry 

products for the presence of salmonella and then compares the results with 

pre-HACCP baseline data. 

Domestic Seafood 

Safety System Does 

Not Effectively Protect 

Consumers 

From Unsafe Seafood 

FDA has made some progress in ensuring the safety of domestic seafood 

consumed by the public. According to FDA’s December 2000 report on the 

evaluation of the HACCP system for seafood, the percentage of seafood 

firms with a HACCP plan that included all of the required components 

increased from 31 percent in 1998 to 44 percent in 1999. However, FDA 

recognizes that gaps still exist in HACCP’s implementation and that certain 

segments of the industry are lagging behind. Our evaluation shows that 

several flaws in FDA’s system for ensuring the safety of domestic seafood 

may allow unsafe seafood products to reach consumers. First, a significant 

number of seafood firms and/or products are not operating under the 

HACCP regulations. Second, even when seafood-processing firms are 

subject to HACCP requirements, FDA inspections do not fully evaluate the 

firms’ operations because such inspections were frequently limited to a 

paperwork review rather than actual observation of product processing. 

Furthermore, at both these inspections and those where FDA observed the 

processing of products subject to HACCP requirements, the agency found 

that over half of the HACCP plans had serious violations. Third, when 

violations of regulatory significance were identified, FDA did not take 

timely action to issue warning letters notifying seafood firms that they must 

correct the violations promptly and adequately to avoid further 

enforcement action, such as seizure or injunction. Finally, FDA lacks, and 

has no immediate plans to obtain, the basic information needed to assess 

the effectiveness of its HACCP requirements to ensure the safety of 

seafood. 
Page 14 GAO-01-204 Federal Oversight of Seafood

Many Seafood Firms Are 

Excluded From HACCP 

Requirements 

HACCP regulations apply to all seafood-processing firms, but a significant 

number do not operate HACCP systems. As a result, the benefits of 

HACCP—identifying and controlling food safety hazards—are not being 

fully obtained, thus placing consumers at risk of consuming unsafe 

seafood. 

While FDA is responsible for overseeing all seafood-processing firms 

operating in interstate commerce, it does not have an effective system to 

identify such entities because it does not have a registration requirement 

for seafood firms. Although the exact number of seafood firms under FDA’s 

jurisdiction is unknown, industry and government officials believe it is 

larger than the approximately 3,600 or so seafood firms in FDA’s official 

inventory. FDA officials stated that the agency has the authority to register 

some seafood-processing firms under its authority to impose emergency 

permit control regulations. However, the agency does not require 

registration of any seafood-processing firm except those that process lowacid or acidified canned food.10 FDA uses a variety of ways to identify 

seafood firms under its jurisdiction, including checks of the telephone 

book yellow pages, newspapers, magazines, trade periodicals, state 

inventory records, and consumer complaints. However, we reported in the 

past that such identification efforts are time-consuming, costly, and 

ineffective and pointed out to FDA that a simple registration system based 

on a requirement that processors operating in interstate commerce notify 

FDA when they begin operations would cost little.11

Furthermore, while all land-based seafood-processing firms are subject to 

HACCP requirements, thousands of commercial fishing vessels are exempt, 

even though they may present hazards and risks similar to those posed by 

land-based seafood-processing firms. FDA’s HACCP regulations exempt 

vessels that (1) harvest and transport fish without any further processing 

10FDA’s authority to require firms to register is based on 21 U.S.C. 344. Section 344 allows 

FDA to impose emergency permit control regulations on manufacturers, processors, or 

packers whose food operations may be contaminated with microorganisms that are (1) 

injurious to health and (2) cannot be adequately determined after being released into 

interstate commerce. So far, FDA has used this authority only to regulate acidified foods and 

the thermal processing of low-acid foods packaged in hermetically sealed containers. 21 

C.F.R. 108.25(c)(1) and 108.35(c)(1).

11See Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure 

Safe Food Supply (GAO/RCED-92-152, June 26, 1992) and Food Safety and Quality: 

Limitations of FDA’s Bottled Water Survey and Options for Better Oversight (GAO/RCED-92-

87, Feb. 10, 1992).
Page 15 GAO-01-204 Federal Oversight of Seafood

and (2) head, eviscerate, or freeze fish on board solely to prepare them for 

holding. Fishing vessels that process fish beyond these provisions, (e.g., 

factory ships that fillet or pack their catch), are subject to HACCP 

requirements. Currently, FDA’s inventory shows that 250 vessels are subject 

to HACCP requirements. However, the number of vessels that should be 

subject to HACCP requirements and inspections is not known because 

neither FDA nor any other organization we contacted has information on 

vessels that process fish on board. An official for the state of Alaska noted 

that the number of vessels that process fish on board and are thus subject 

to state inspections is almost twice as large as the number of vessels in 

FDA’s inventory. Also, an official in one of FDA’s district offices noted that 

from 400 to 800 fishing vessels in his district may perform some type of 

processing. 

FDA officials said they decided to exempt most vessels from the regulatory 

definition of “processors” and thus exempt them from HACCP regulations 

because of practical considerations. Namely, the fishing fleet is so large 

that FDA believes that inspecting the fleet would overwhelm the inspection 

system. FDA also believes that if it requires the fleet to comply with 

HACCP requirements, some fishing vessels may decide to avoid heading 

and gutting fish on board. FDA officials said that this would pose a greater 

risk for product safety and quality. While these observations have merit, the 

HACCP regulations are intended to cover the heading, eviscerating, or 

freezing of seafood products so that hazards reasonably likely to occur 

during these processing steps may be controlled.

Finally, about one-third of the seafood products FDA inspected are not 

required to have a HACCP plan, including many products at warehouses 

and repacking firms. Under the seafood HACCP regulations, seafoodprocessing firms are required to identify the food safety hazards that are 

reasonably likely to occur and implement measures to control these 

hazards; then FDA inspectors independently make a similar assessment 

during their inspections. If the seafood firm determines and the FDA 

inspector agrees that no hazards are reasonably likely to occur, the seafood 

firm is not required to have a HACCP plan for the products inspected. FDA 

inspectors may determine that a firm does not need a HACCP plan because, 

in their view, the product is of low risk.
Page 16 GAO-01-204 Federal Oversight of Seafood

According to FDA’s statistics for inspections in 1999, HACCP plans were 

not required for 30 percent, or 1,055, of the 3,525 products inspected 

because the inspector determined that no hazards were reasonably likely to 

occur. For example, on the basis of the seafood hazards guide, FDA 

inspectors concluded that there were no risks associated with 516 products 

because storage at warehouses and repacking firms did not present a 

significant hazard. Therefore, HACCP plans were not needed for seafood 

products at these locations. FDA officials said that most warehouses do not 

handle high-risk products, such as scombroid species. However, 

temperature controls for refrigerated products are very important to 

prevent certain hazards, such as botulism in smoked vacuum-packed 

products or scombroid poisoning in certain fish species. FDA officials said 

that final product storage, especially for nonfrozen product, is a weakness 

at some seafood firms because refrigeration problems, such as equipment 

breakdowns or uncalibrated thermometers, may prevent these firms from 

keeping seafood products at appropriate temperatures.12 Our review of a 

sample of FDA inspection reports from three districts verified that some 

firms experience problems ensuring that temperatures are maintained. For 

example, we estimate that in about 30 percent of these reports, FDA 

inspectors found that instruments such as freezer and cooler thermometers 

were not properly calibrated. Without a HACCP plan with critical controls 

and monitoring procedures, such problems may go undetected for 

prolonged periods of time and jeopardize product safety.

In contrast, USDA’s regulations for meat and poultry products require that 

every plant in its inventory of approximately 5,700 plants, identify at least 

one critical control point for each identified hazard. Agency officials said 

they are not aware of any meat and poultry operations that can be deemed, 

categorically, to pose no likely hazards.13 Some USDA officials involved 

with meat and poultry regulation, including the Assistant Deputy 

Administrator for District Enforcement Operations, stated that it is difficult 

to understand how no hazards are likely to occur in seafood firms. 

12In its comments on a draft of our report, FDA said that frozen products are most likely to 

remain that way even if electrical outages occur because modern day freezers are able to 

retain cold.

13Fed. Reg. 4561 (Jan. 30, 1998).
Page 17 GAO-01-204 Federal Oversight of Seafood

FDA Is Not Effectively 

Ensuring HACCP 

Implementation

FDA uses on-site unannounced inspections to assess a firm’s compliance 

with HACCP requirements. As part of this process FDA inspects the 

general sanitary conditions of the firm and equipment. Critical components 

of the inspection also include an evaluation of HACCP plans, review of 

HACCP records, and in-plant observations of the product selected for 

inspection. However, we found that FDA inspectors frequently could not 

conduct in-plant observations of the selected product. We estimate that in 

almost half (48 percent) of the seafood inspections at three FDA districts in 

fiscal year 1999, the selected product was not being processed on the day 

of the inspection. In other words, FDA inspectors did not make an in-plant 

observation of the product but instead conducted a paperwork review. FDA 

officials said that because inspections are unannounced, there were 

instances where the product selected was not being processed and FDA 

inspectors were limited to a review of plant records to verify compliance. 

FDA’s compliance manual recommends that inspectors return to physically 

inspect the product if at the time of their plant visit, the product was not 

being processed. However, FDA inspectors generally did not return to the 

firm to inspect the products originally selected for inspection. Officials in 

the three districts we visited said that, as a general rule, insufficient 

inspection resources prevent them from returning to observe the selected 

product. FDA inspection records did not show such follow-up inspections, 

and FDA inspectors told us they did not conduct them. In an October 1999 

memorandum to FDA District Directors, FDA acknowledged the need to 

observe the selected product during processing by stating that HACCP 

inspections emphasized the need for more in-plant observations of the 

selected products. An FDA official explained that inspectors should spend 

most of their inspection time observing the selected product in the 

processing environment, especially those that are considered high-risk.
Page 18 GAO-01-204 Federal Oversight of Seafood

In addition, almost 3 years after HACCP was implemented, FDA’s data on 

industry compliance shows that many seafood firms have yet to meet the 

basic requirements for a HACCP plan. That is, 22 percent (542 of 2,470) of 

the products inspected by FDA in 1999 that required a HACCP plan did not 

have one.14 Of those that did have a HACCP plan as required, FDA’s data 

show that more than half (1,080 of 1,928) contained serious deficiencies, 

according to FDA inspectors. The plans were judged to have serious 

deficiencies because, according to FDA’s compliance manuals, they (1) did 

not identify hazards that FDA considers serious, such as pathogens and 

toxins; (2) did not identify an appropriate critical control point where the 

hazard could be controlled; (3) did not identify an appropriate critical limit, 

or operating parameter for the critical control point; (4) did not identify 

appropriate monitoring procedures; (5) did not identify appropriate recordkeeping procedures; and (6) did not identify adequate corrective action 

procedures.15

According to FDA officials, the grading system used for this evaluation 

required that HACCP plans have all five of the most significant components 

adequately addressed and, therefore, was a rigorous evaluation of the 

industry’s compliance.16 FDA said that it was not easy for seafood firms to 

score 100 percent on all elements, even though they succeeded in many of 

the individual elements. In general, FDA believes that it will take time for 

all of the seafood firms subject to HACCP regulations to fully comply with 

the requirements. In its December 2000 HACCP evaluation report for 

seafood, FDA said it would intensify its inspection efforts to focus on 

improving compliance.

Our analysis of a probability sample of inspections’ records from three FDA 

districts yielded similar results. We estimate that in about 55 percent of the 

FDA inspections of products with HACCP plans, the inspector found one or 

14FDA reviews only one or two product types during an inspection, although some firms 

produce more than two types.

15Detailed information on seafood-processing firms’ compliance with HACCP requirements 

comes from FDA’s National Seafood HACCP Inspection Database, initiated in 1998. The 

database provides details of seafood processors’ preventive controls, which, according to 

FDA officials, allows FDA to focus inspections on problem areas and evaluate the state of 

the industry in-depth.

16The five basic components include the identification and description of hazards, critical 

control points, critical limits, monitoring procedures, and record-keeping procedures for all 

of the hazards that apply to that firm.
Page 19 GAO-01-204 Federal Oversight of Seafood

more serious violations. Table 1 summarizes the type and estimated 

frequency of the violations identified by FDA inspectors. 

Table 1: Estimated Percentage of Occurrences of Nine Types of Serious HACCP 

Violations in Fiscal Year 1999 Inspection Records for Three FDA Districts

a

See appendix 1 for sampling errors for these estimates. These estimates are based only on cases for 

which the product had a HACCP plan. The only exception was the estimates of the inadequate 

identification of critical control points, which is based on cases for which the product had a HACCP 

plan and for which the 1999 version of Form 3501 (Domestic Seafood HACCP Report) was used to 

record the inspection results. Each case could be subject to more than one type of violation.

The potential health risks associated with these violations are significant 

because they can involve the failure to establish critical limits for high-risk 

products, such as cooked ready-to-eat seafood. The failure to establish 

cooking critical limits for cooked ready-to-eat products can allow 

pathogens such as listeria monocytogenes to survive, and possibly cause 

listeriosis—a serious and often fatal condition to humans. FDA’s 

compliance data for fiscal year 1999 show that 40 percent of the HACCP 

plans covering cooked ready-to-eat products did not establish adequate 

time and temperature critical limits to prevent, reduce, or eliminate these 

types of hazards. 

Even if the plans were complete, according to FDA requirements, they 

would still omit a serious hazard because methylmercury, a highly toxic 

substance, is not identified or covered in FDA’s seafood guide as a hazard 

reasonably likely to occur. According to a July 2000 National Research 

Council report, contaminated fish is the major source of human exposure 

Type of violation

Estimated percentage of

occurrencesa

Inadequate identification of hazards 16

Inadequate identification of critical control points 21

Inadequate identification of critical limits 23

Inadequate written monitoring procedures 16

Inadequate implementation of monitoring 

procedures

21

Inadequate identification of corrective action 

procedures 

21

Inadequate corrective actions 12

Inadequate monitoring records 31

Inadequate corrective actions records 9
Page 20 GAO-01-204 Federal Oversight of Seafood

to methylmercury in the United States and can cause, among other things, 

serious neurological problems, such as mental retardation in young 

children. The risk to public health posed by methylmercury is based on 

how much of the contaminant is in fish and how much fish people eat.

FDA’s guidance to industry does not discuss the identification and control 

of methylmercury even though FDA’s tests for methylmercury in shark and 

swordfish found that 9 of 18 samples analyzed in 1998 and 1999 met or 

exceeded FDA’s 1.0-part-per- million action level.17 These test results 

pertained to imported products.

FDA officials said that most commercial seafood species have very low 

levels of methylmercury. They also said that the species that contain the 

highest average amounts of methylmercury—shark and swordfish—are 

expensive and, therefore, consumed infrequently. Thus, FDA considers 

that, in most species, methylmercury is not a hazard that is reasonably 

likely to occur and that HACCP controls are not needed. Furthermore, 

FDA’s position is that if there were an industrial incident or similar event 

that could raise the levels of mercury in commercial seafood, they would 

examine whether HACCP controls are warranted and issue new guidance 

as necessary. 

FDA has been evaluating new data on the health effects of methylmercury 

from the consumption of fish. However, the agency has not established a 

timeline for completing its evaluation. Moreover, FDA officials stated that 

the agency is unlikely to include any guidance to industry in the next 

edition of its Fish and Fisheries guide to be issued in calendar year 2001. In 

the meantime, FDA advises industry and inspectors not to identify 

methylmercury as a hazard reasonably likely to occur. However, before 

HACCP’s implementation, FDA’s draft Fish and Fisheries Guide identified 

methylmercury as a potential hazard in certain seafood species consumed 

by humans, including swordfish and tuna. Furthermore, in 1995, FDA 

updated its consumer advisory warning pregnant women and women of 

childbearing age to limit their consumption of shark and swordfish because 

of potential methylmercury contamination. In January 2000, FDA revised 

its methylmercury advisory and now recommends that women who are 

pregnant, or who are of childbearing age and may become pregnant, avoid 

17“Action levels” are agency guidelines that, when exceeded, may pose a threat to public 

health. 
Page 21 GAO-01-204 Federal Oversight of Seafood

eating the four species of fish known to have the highest levels of 

methylmercury: shark, swordfish, king mackerel, and tilefish.

Even when FDA identifies serious violations at a seafood-processing firm, 

it does not take timely regulatory action to ensure compliance. When 

interactions between inspection personnel and plant personnel fail to 

obtain compliance, warning letters are the principal means of notifying the 

plants of serious violations and achieving prompt corrective action before 

proceeding to more stringent enforcement actions. Warning letters are to 

be issued for violations of regulatory significance—i.e., violations that 

affect product safety and may lead to enforcement action, such as product 

seizure or injunction, if not promptly and adequately corrected. To ensure 

the prompt and adequate correction of serious violations, FDA’s regulatory 

procedures manuals state that warning letters should be approved within 

15 working days of the receipt of the district office’s recommendation.

According to FDA’s analysis of 52 warning letters processed in calendar 

year 2000, 94 percent, or 49, exceeded recommended issuance time frames 

thus significantly delaying notification to industry of observed problems 

that needed correction. On average, 73 days elapsed between the receipt of 

the district offices’ recommendation and the approval of the warning 

letters.

Our analysis of 162 warning letters issued to domestic firms nationwide 

after inspections conducted in fiscal year 1999 parallels these findings—

that is, three-quarters of the letters exceeded the issuance time frames by 

30 days or more. More significantly, we found that 67 percent of these 

letters were associated with high-risk products, including scombrotoxinsusceptible seafood, which, if not properly handled, could cause serious 

health problems requiring hospitalization, particularly in the case of elderly 

individuals. 

FDA headquarters officials explained that issuance time frames are 

exceeded primarily because of the need to ensure that recommendations in 

district offices’ warning letters are consistent with agency policy. They 

explained that changes in agency policy are sometimes necessitated by 

changes in the science associated with HACCP systems and that, in some 

cases, a significant amount of time is needed to review new or updated 

policy to ensure that it is interpreted correctly. Also, a significant number 

of the recommendations in the domestic warning letters submitted by the 

districts require changes because the letters did not correctly cite serious 

or critical deficiencies. FDA district officials cited an increase in the 
Page 22 GAO-01-204 Federal Oversight of Seafood

number of warning letters issued and the lack of adequate resources as 

reasons for not meeting the issuance time frames for warning letters. In 

this regard, an October 1999 FDA memorandum states that an analysis of 

recommendations in warning letters showed that only 5 percent of the 

district offices’ draft warning letters were approved as written. On the basis 

of its review, FDA headquarters provided a summary of the problems 

identified to field personnel and boilerplate language to be used in warning 

letters to help correctly communicate the problems identified during 

inspections.

FDA Lacks Information to 

Assess the Effectiveness of 

HACCP Requirements for 

Seafood 

FDA lacks objective, measurable data to determine whether its HACCP 

program for seafood is effectively reducing hazards. Currently, neither FDA 

nor the industry is required to collect such data, and FDA officials said that 

they have no plans to require data collection in the future because seafood 

products are subject to many different hazards, making it difficult to select 

one or more to measure. 

A guiding principal of the Government Performance and Results Act is the 

development and use of objective and measurable performance measures 

to demonstrate results on how well an organization is achieving its goal. In 

this regard, prior to the implementation of its HACCP program, USDA 

determined the prevalence of salmonella—a microbial organism—in meat 

and poultry so that it could evaluate whether HACCP requirements were 

effective in lowering salmonella levels. USDA set targets for reducing the 

incidence of salmonella contamination in meat and poultry products by 

establishing performance standards. Recent USDA reports show that, 

under this program, the levels of salmonella contamination in meat and 

poultry are declining.

FDA has no baseline data or requirement to systematically measure any 

changes in the level of seafood contaminants, although the agency did test 

a limited number of seafood samples for surveillance and compliance 

purposes. In 1999, FDA analyzed a total of 769 domestic seafood samples 

(of which 473 were analyzed for the presence of biological hazards) and 

found that 94, or 20 percent, contained hazards such as salmonella, listeria, 

and scombrotoxin.18 FDA officials said that, unlike meat and poultry, 

18FDA officials said that the samples collected were collected on a “for-cause” basis. That is, 

the samples represent products that FDA suspected were going to be violative and, 

therefore, are not representative of the food supply.
Page 23 GAO-01-204 Federal Oversight of Seafood

seafood is affected by a variety of microbiological and chemical pathogens 

and that there is no single widespread bacterial hazard, such as salmonella, 

in meat and poultry. 

While all seafood may not be affected by a single widespread hazard, such 

as salmonella, some species of seafood are often affected by specific 

hazards. For example, tuna, mahi-mahi, and bluefish are likely to produce 

histamines when not kept at the proper temperature. The resulting 

illness—scombroid poisoning—causes nausea, diarrhea, sweating, and 

headaches. Similarly, subtropical and tropical fish, including grouper and 

snapper, accumulate a naturally occurring toxin, called “ciguatoxin.” 

Ciguatera poisoning involves a combination of gastrointestinal 

neurological and cardiovascular disorders. Scombrotoxin and ciguatoxin, 

which cannot be eliminated by cooking, contributed to over 88 percent of 

all confirmed food illness outbreaks for seafood reported by CDC in 1997.

While FDA does not have a performance-based method for measuring 

reductions in seafood-related hazards, it does collect data on seafood firms’ 

compliance with regulatory requirements and uses those data to evaluate 

progress. For example, in 1992, FDA compiled descriptive compliance data 

from seafood firms that handled high-risk products. The data describe the 

processes in place, such as the types of monitoring systems, and some of 

the problems identified in 1992, such as the extent of sanitation violations. 

Although FDA compared HACCP compliance data from 1998 and 1999 with 

the 1992 data, the results do not objectively measure whether seafood 

produced under the HACCP system has experienced measurable reduction 

in contamination. 

FDA’s Approaches to 

Ensuring the Safety of 

Imported Seafood Are 

Not Effective

As with domestic products, FDA’s approaches for ensuring the safety of 

imported seafood provide only limited protection against unsafe seafood 

reaching consumers. First, FDA has been unable to develop equivalence or 

compliance agreements that document foreign countries’ equivalence or 

compliance with the U.S. seafood safety system. Second, FDA’s reviews of 

importers’ documentation have shown that many do not have records of 

foreign seafood firms’ compliance with U.S. requirements for HACCP 

programs as is required in the absence of equivalence agreements. When 

documentation has been available, it often did not adequately demonstrate 

such compliance. Third, although FDA inspects some foreign firms and 

often finds serious deficiencies, it does not take follow-up actions, such as 

automatically detaining products from these firms at U.S. ports. Fourth, 

FDA’s traditional strategy of visually examining and/or testing imported 
Page 24 GAO-01-204 Federal Oversight of Seafood

seafood at U.S. ports has been widely discredited as an effective method 

for ensuring the safety of imported foods. Moreover, FDA’s port of entry 

examinations and testing are unable to keep pace with the growing level of 

imports. 

FDA Lacks Country-toCountry Equivalence 

Agreements

FDA has authority to enter into voluntary agreements with individual 

countries recognizing the equivalence or compliance of their seafood safety 

systems. Moreover, under the provisions of the World Trade Organization 

Agreement on the Application of Sanitary and Phytosanitary Measures 

(SPS Agreement), the agency is obligated to at least take equivalence 

requests from other countries under consideration.19 FDA defines 

equivalence agreements as those in which FDA finds one or more of an 

exporting country’s requirements equivalent to our own.

Currently, however, FDA has no equivalence or compliance agreements 

with countries that export seafood to the United States, although the 

agency has compliance agreements for molluscan shellfish (fresh and 

frozen oysters, clams, mussels, and whole or roe-on scallops).20 FDA 

officials said that they have received requests for equivalence 

determinations from approximately 30 countries that export seafood to the 

United States. After an initial review, FDA concluded that 8 of the 30 

interested countries were viable candidates and is now discussing 

equivalence agreements with Australia, Canada, and New Zealand and a 

compliance agreement with Japan. However, FDA has not developed a 

timetable for completing these agreements. Furthermore, according to 

FDA officials, the agency is considering how seafood safety processes or 

procedures might change, should it complete an equivalence agreement, 

but has not made any decisions yet. Specifically, the agency is considering 

(1) adjusting the rate at which the agency examines imports at ports of 

entry in order to focus more attention on imports from countries not yet 

found to be equivalent, (2) having a standing arrangement for immediate 

inspection by the regulatory authority in the exporting country whenever a 

problem is found with a product being offered for entry into the United 

19See article 4, Agreement on the Application of Sanitary and Phytosanitary Measures, World 

Trade Organization Agreement, 1994. 

20Compliance agreements are those in which each side pledges compliance by its producers 

with the requirements of the other importing country. FDA has memorandums of 

understanding regarding molluscan shellfish with Canada, Chile, Korea, Mexico, and New 

Zealand.
Page 25 GAO-01-204 Federal Oversight of Seafood

States, and (3) the frequency of on-site audits in countries with which the 

agency develops equivalence agreements.

FDA officials acknowledge that equivalence agreements would help ensure 

that adequate safety and sanitation standards exist for imported seafood. 

FDA officials said that the United States and Canada have had discussions 

and have engaged in activities aimed at determining the equivalence of the 

two systems. These discussions began in the summer of 1997. FDA and 

Canadian officials would not discuss in detail the ongoing deliberations 

regarding each other’s system. They said that the time required to 

determine equivalence is partly due to Canada’s changes to its seafood 

safety system in 1997 that required a reevaluation by FDA. However, 

Canadian concerns with the U.S. system also contributed to the long 

discussions. Officials of the Canadian Food Safety Inspection Agency said 

that during their on-site visit of U.S. seafood plants, they identified a 

number of areas of concern with the U.S. system, such as FDA’s not 

verifying the adequacy of HACCP plans before seafood firms implemented 

them. In Canada, seafood firms must submit their HACCP plans to the food 

inspection agency for review before they are implemented. Appendix III 

provides further information on selected aspects of the U.S., Canadian, and 

Chilean seafood safety inspection systems. 

Unlike USDA, FDA is not legally required to certify that countries that 

export food products to the United States have safety, sanitation, and 

inspection programs that provide an equivalent level of safety to that of the 

U.S. system. Under the meat and poultry inspection acts, USDA’s Secretary 

of Agriculture must certify that exporters of meat and poultry products 

have equivalent food safety systems before their products can be exported 

to the United States. As of January 1, 1998, the Secretary had certified that 

37 countries had equivalent systems. In our 1998 report on imported food 

safety, we concluded that the lack of equivalence requirements for FDAregulated imported foods adversely affects the agency’s ability to keep 

unsafe foods out of U.S. commerce.21 We recommended that Congress 

strengthen FDA’s ability to ensure the safety of imported foods by requiring 

that all food eligible for importation to the United States—not just meat 

and poultry—be produced under equivalent food safety systems. Because 

equivalence agreements with major exporters of seafood to the United 

States are lacking, FDA relies on a review of paperwork at importers’ 

offices to attempt to determine whether importers have met their 

21See GAO/RCED-98-103.
Page 26 GAO-01-204 Federal Oversight of Seafood

responsibilities and requirements under the seafood HACCP regulations. 

While legislation was introduced in 1999, Congress has not yet acted to 

strengthen FDA’s ability to ensure that imported foods, including seafood, 

be produced under equivalent safety systems.

Most Importers Lack 

Required Documentation to 

Demonstrate Compliance 

With HACCP Requirements

In the absence of any seafood equivalence agreements between the U.S. 

and foreign countries, federal regulations hold importers responsible for 

demonstrating that the seafood they bring into the United States is 

produced under systems that are equivalent to or compliant with HACCP 

requirements for domestic seafood. The HACCP regulations for seafood 

require importers to obtain products from a country with which FDA has 

an equivalence agreement or to take affirmative steps to document foreign 

firms’ efforts to comply with the U.S. requirements. Figure 2 shows 

regulatory requirements for importers and the documentation they can use 

to demonstrate compliance. However, less than a third of the importers 

that FDA inspected met these requirements, according to our analysis of 

FDA’s inspection records of importers for fiscal year 1999.
Page 27 GAO-01-204 Federal Oversight of Seafood

Figure 2: Importers’ Regulatory and Compliance Requirements



Importer purchases 

seafood from country 

with an equivalency

agreement with FDA

Importer cannot 

use this option because there

are no seafood agreements

Regulations require that importers

meet 1 of 2 conditions (A or B)

(1) a written product 

	 specification is on file

and

(2) documentation of at least 

	 one of six affirmative steps exists 

	 (a) HACCP and sanitation records from processor

	 (b) lot-by-lot certification from foreign inspection 

	 	 authority or third party

	 (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) periodical 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
Page 28 GAO-01-204 Federal Oversight of Seafood

We found that importers had the required product documentation for less 

than one-third of the products inspected.22 That is, only 27 percent (116 of 

432 seafood products) listed in the FDA inspection forms showed that the 

importer had (1) a written product specification document23 and (2) 

documentation for at least one of the six possible affirmative steps required 

by the regulations. Of those that had the required documentation on file, 57 

percent (66 of 116) had a copy of the foreign firms’ HACCP plan and written 

guarantee, and 50 percent (58 of 116) had a copy of a lot-by-lot certificate 

from the foreign government’s inspection authority. Few importers (16 

percent, or 18 of 116), chose regular inspections of the foreign processor’s 

facilities as a method for demonstrating compliance.

Furthermore, the FDA inspection forms showed that, in many cases, the 66 

HACCP plans that the importers obtained did not identify hazards that, 

according to FDA’s seafood guide, are reasonably likely to occur, although 

exceptions may occur in each specific case, as shown in the following 

examples:24

• Thirteen of the HACCP plans were for scombroid species (tuna, mahimahi, and bluefish), but only 6 identified scombrotoxin as a hazard 

reasonably likely to occur. FDA’s seafood guide states that it is 

reasonable to assume that, without proper controls, these species of fish 

will contain unsafe levels of histamine, resulting in the formation of 

scombrotoxin. 

• Twelve of the HACCP plans were for shrimp, which may contain 

sulfites—a chemical hazard, but only 3 identified any chemical hazards 

as being reasonably likely to occur.

22To record importer inspection findings, FDA inspectors fill out a standardized form 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. 

HACCP requirements. We obtained and analyzed all of FDA’s inspection forms for fiscal year 

1999 that were completed at 350 importer firms (covering 432 seafood products).

23Written product specifications are designed to ensure that the product is not adulterated 

under section 402 of the Federal Food, Drug, and Cosmetic Act.

24The guide gives information on determining which hazards are “reasonably likely to occur” 

under ordinary circumstances and, thus, provides information that would likely result in a 

HACCP plan that is acceptable to FDA. 
Page 29 GAO-01-204 Federal Oversight of Seafood

• Fifteen of the HACCP plans described processing steps, such as filleting 

and mixing, that can present physical hazards, such as metal fragments. 

But only two of those HACCP plans identified such hazards.25

• Eight of the HACCP plans involved such species as grouper, mackerel, 

and snapper, which can carry ciguatoxin, but none of them identified 

ciguatoxin as a hazard that was reasonably likely to occur. Ciguatoxin is 

one of the leading causes of seafood-related illnesses, according to 

CDC’s data.

FDA issued warning letters to 33 importers for serious deviations from the 

HACCP regulations. Forty-eight percent (15 of 33) of the warning letters 

noted repeat violations from the previous inspection, such as the failure to 

adequately perform one of six affirmative steps and the failure to have 

written product specifications. 

To further ensure the safety of imported seafood, FDA issued an import 

alert in January 1998 that is to be used to detain seafood products destined 

to importers that did not verify foreign seafood firms’ compliance with U.S. 

HACCP requirements. The import alert is to be adjusted to include 

importers that do not meet HACCP requirements. However, despite the 

number of violations identified by inspectors and noted in warning letters 

to seafood importers, FDA had listed only two of these importers on the 

alert. FDA’s recently released report on its seafood program acknowledges 

that importers have experienced problems with major provisions of the 

importer requirements, but FDA officials said that educating importers on 

their responsibilities is important.26 FDA’s strategy is to provide importers 

with additional information about HACCP requirements, coupled with FDA 

enforcement.

25The guide states that under ordinary circumstances, it would not be reasonably likely to 

expect that metal fragments could enter the food from manual cutting. The inspection forms 

that we reviewed did not specify whether the cutting was manual or mechanical.

26“FDA’s Hazard Analysis Critical Control Point (HACCP) Program for Seafood for Calendar 

Years 1998 and 1999” (Dec. 9, 2000).
Page 30 GAO-01-204 Federal Oversight of Seafood

FDA Does Not Take 

Enforcement Actions on 

Deficiencies Identified in Its 

Overseas Inspections

FDA conducts limited inspections of selected foreign seafood firms to 

determine the firms’ compliance with the agency’s seafood regulations.27

FDA personnel visited four foreign countries in fiscal year 1999—Ecuador, 

Vietnam, Taiwan, and the Philippines—to inspect 37 seafood firms and to 

provide education on the U.S. HACCP requirements. None of these foreign 

visits were conducted for equivalence determination purposes. During 

those inspections, FDA found numerous HACCP-related problems, and 

issued 24 warning letters to foreign firms. However, only about half of them 

responded to FDA’s letters. To date, FDA has not taken further enforcement 

actions against the nonresponding firms. Table 2 provides examples of the 

types of problems that FDA found during these inspections.

Table 2: Problems Found During Inspections in Four Exporting Countries, Fiscal Year 1999

27FDA’s criteria for selecting foreign firms includes previous compliance problems and the 

volume of seafood exported to the United States. 

Countries 

Visited

Number of

firms

inspected

Number of FDA 

warning letters and 

foreign firm 

responsesa Examples of problems found

Ecuador 10 Six warning letters 

issued—three 

responses received

No HACCP plan.

HACCP system and sanitation monitoring inadequate for tuna.

Hazards not listed in HACCP plan.

HACCP plan did not identify hazards, such as aquaculture drugs and 

environmental chemical contaminants for farm-raised fish and shrimp.

Clostridum botulinum hazard was not adequately controlled.

HACCP plan did not identify a potential hazard—staphylococcus aureus—

and did not control its formation in hydrated batter mixes.

Taiwan 9 One warning letter 

issued—one response 

received

HACCP plan did not identify potential histamine hazards in scombroid 

species.

HACCP plan did not address aquaculture drugs or environmental 

chemical hazards. 
Page 31 GAO-01-204 Federal Oversight of Seafood

a

As of April 28, 2000.

When FDA notes deficiencies during foreign visits and they are not 

corrected, FDA can place the foreign product under import alert and detain 

it at the U.S. port of entry for further examination and testing. In 1998, FDA 

issued a generic import alert to cover all foreign firms that do not comply 

with HACCP requirements. An official in FDA’s imports office said that he 

is unaware of any instances where deficiencies identified by the Office of 

Seafood and the Office of Regulatory Affairs during foreign country visits 

were communicated to the imports office. If the deficiencies had been 

communicated, the import alert could be updated to ensure that products 

from foreign firms where problems were identified could be subjected to 

increased scrutiny at the port of entry. After we discussed this matter with 

senior FDA officials, FDA added nine firms to the import alert and is in the 

process of adding another firm. Nonetheless, FDA believes that the foreign 

seafood firms they visited are making progress in learning and complying 

with the new HACCP requirements.

Port of Entry Inspections 

Are Widely Discredited 

FDA may detain individual shipments at U.S. ports of entry so it can 

conduct visual examinations and/or collect and test product samples while 

it determines if the product is misbranded or adulterated. However, port of 

entry inspections for imported food have been widely discredited as an 

effective means for ensuring product safety. Furthermore, FDA’s port of 

entry examinations have been unable to keep pace with the growing 

volume of seafood product imported into the United States. 

Countries 

Visited

Number of

firms

inspected

Number of FDA 

warning letters and 

foreign firm 

responsesa Examples of problems found

Philippines 9 Nine warning letters 

issued—three 

responses received

HACCP plan did not list hazards, critical limits, and monitoring 

procedures.

Monitoring controls for critical control points were nonexistent or 

inconsistent, and corrective actions were inappropriate.

Vietnam 8 Eight warning letters 

issued—six responses 

received

Processor did not have records to indicate that scombroid species were 

histamine-free.

HACCP plan did not identify aquaculture drugs and environmental 

chemical hazards.

(Continued From Previous Page)
Page 32 GAO-01-204 Federal Oversight of Seafood

According to the U.N. Food and Agriculture Organization, testing products 

at the port of entry involves a concentration of inspection resources on the 

imported product itself and is an attempt to compensate for a lack of 

knowledge about the producer’s processing, hygiene, and sanitation 

practices. Recognizing the limitations of this method, FDA’s draft guidance 

on equivalence criteria states that, by itself, the end-product inspection and 

testing at the port of entry cannot be relied upon to provide adequate 

protection. In our 1998 report on imports, we also reported that reliance on 

end-product testing is an ineffective, resource-intensive, and statistically 

invalid approach to ensuring the safety of imported food. We made a 

number of recommendations to improve the effectiveness of FDA’s port of 

entry-inspection system, such as providing inspectors with more consistent 

and accurate data for selecting imported products for inspection but 

emphasized that FDA’s reliance on port of entry inspections was an 

ineffective means for ensuring the safety of imported food. Therefore, to 

strengthen FDA’s ability to ensure the safety of imported food, we 

recommended that Congress require all food eligible for importation to the 

United States—not just meat and poultry—be produced under equivalent 

food safety systems.28

Furthermore, FDA’s port of entry inspections are unable to keep pace with 

the growing volume of imported seafood products. For example, from 1998 

through 1999, imported seafood products increased by 7 percent (from 3.6 

billion to 3.9 billion pounds), while the proportion of foreign seafood 

entries detained for visual and/or laboratory examination decreased from 5 

to 3 percent. In 1999, less than 1 percent of imported seafood entries were 

subjected to the laboratory portion of the examination. According to FDA 

officials, insufficient resources and an increased volume of imported 

seafood products resulted in the reduced rate of FDA port of entry 

inspections and tests of imported seafood products. While increased 

resources would be helpful, as we have previously reported, the most 

effective method to ensure the safety of imported seafood is to certify that 

imported products are produced under equivalent food safety systems. 

Conclusions Since FDA first issued the HACCP regulations for seafood, seafoodprocessing firms have made some progress in implementing the new 

system. However, several important weaknesses compromise the overall 

28See GAO/RCED-98-103, and Food Safety: Changes Needed to Minimize Unsafe Chemicals 

in Food (GAO/RCED-94-192, Sept. 26, 1994).
Page 33 GAO-01-204 Federal Oversight of Seafood

effectiveness of the federal seafood safety system. If left uncorrected, they 

will continue to undermine the goal of HACCP systems—that is, controlling 

hazards in the production process before the product reaches the market. 

More importantly, U.S. consumers may continue to be placed at risk of 

contracting foodborne illness from contaminated domestic and imported 

seafood products. 

Without requiring registration of all domestic seafood firms, FDA cannot 

effectively ensure that all seafood products are processed under the 

HACCP regulations. Similarly, FDA cannot ensure that all seafood products 

are operating under HACCP systems if it continues to exclude vessels that 

meet its criteria for land-based seafood firms. Unless FDA verifies that 

industry identifies and controls all hazards reasonably likely to occur, it 

cannot ensure that industry is implementing an effective HACCP system. 

And without the actual observation of the seafood products selected for 

inspection, FDA inspectors cannot ensure full compliance with HACCP 

requirements. Also, without prompt completion of its ongoing evaluation of 

methylmercury, FDA is unable to give direction to the industry on whether 

it should establish HACCP controls for this hazard, thus potentially placing 

consumers at risk of exposure to unsafe levels of methylmercury. 

Furthermore, without FDA’s timely notification to industry when 

deficiencies are observed, serious problems are not corrected promptly. 

Finally, without baseline data, such as that provided by regular microbial 

testing, FDA is unable to measure the HACCP program’s effectiveness and 

is unable to identify when and where corrective actions are needed.

Concerning imports, FDA does not have seafood equivalence or 

compliance agreements with any foreign country, which is one of the most 

effective methods for ensuring the safety of imports. Lacking such 

agreements, FDA must rely, in part, on a review of importers’ records to 

ascertain that imported products are processed under an acceptable 

HACCP system. However, most importers have not had the required 

documentation to demonstrate that the product offered for entry has been 

processed under HACCP controls. In addition, by not communicating the 

results of foreign firms’ inspections to U.S. port of entry personnel, the 

likelihood that unsafe products from these firms are not inspected prior to 

their release into the U.S. market is increased. Finally, port of entry 

inspections are insufficient to ensure the safety of imported seafood, are an 

inefficient use of resources, and have been unable to keep pace with 

increasing import shipments.
Page 34 GAO-01-204 Federal Oversight of Seafood

Matters for 

Congressional 

Consideration

To strengthen FDA’s ability to ensure that all domestic seafood products 

are processed under HACCP requirements, the Congress should provide 

FDA with comprehensive authority to require the registration of all 

seafood-processing firms. 

To strengthen FDA’s ability to ensure the safety of imported seafood, the 

Congress should amend the Federal Food Drug and Cosmetic Act to 

require FDA to certify that seafood eligible for importation into the United 

States is produced under equivalent food safety systems. 

Recommendations for 

Executive Action

To better ensure the safety of domestic and imported seafood consumed in 

the United States, we recommend that the Commissioner of FDA 

• require that all seafood-processing firms, including vessels that meet 

FDA’s HACCP criteria for land-based seafood firms, operate under 

HACCP requirements;

• conduct in-depth audits of seafood firms that operate HACCP systems 

to verify that they identify and control all hazards reasonably likely to 

occur;

• emphasize to inspectors the need to revisit firms to observe the 

processing of seafood product(s) selected for inspection as required by 

FDA’s compliance manual and establish a system to monitor inspections 

to ensure that such revisits occur;

• develop milestones for completing the agency’s ongoing evaluation of 

methylmercury and determine whether it is a seafood hazard reasonably 

likely to occur;

• issue warning letters within FDA’s required time frames;

• develop baseline information, such as regular microbial test results, and 

use it to assess the effectiveness of HACCP systems over time;

• develop specific goals and time frames for establishing equivalence 

agreements while Congress considers whether to mandate FDA’s 

certification of other countries’ equivalence before their seafood 

products are allowed entry into the United States; and
Page 35 GAO-01-204 Federal Oversight of Seafood

• communicate HACCP system deficiencies identified during FDA’s 

importer inspections and foreign country inspections to port of entry 

personnel so that potentially contaminated imported seafood is 

examined before being allowed tothe United States.

Agency Comments and 

Our Evaluation

We provided FDA with a draft of this report for review and comment. FDA 

stated that it had made significant improvements in the regulation of the 

seafood industry through the establishment of the HACCP system, but 

recognized that areas need to be strengthened. FDA said it plans to or has 

begun actions to address these areas. Regarding the eight specific 

recommendations we made to FDA, the agency generally concurred with 

six and disagreed with two. FDA also raised some concerns about 

inferences that could be drawn from the report. For example, FDA said that 

our draft report implied that seafood was, on the whole, riskier than other 

commercial sources of animal protein because of the way we presented 

foodborne illness outbreak data for seafood in comparison to data for meat 

and poultry. FDA said that, according to CDC, outbreak data should not be 

used to determine whether seafood is more or less dangerous than other 

foods. We modified our report to include the actual number of cases 

associated with seafood and meat and poultry outbreaks. We also added 

CDC’s observation that diagnosable illnesses, such as scombroid poisoning 

from seafood, are more easily recognized than illnesses from nonspecific 

gastrointestinal symptoms caused by other foods. (See app. IV for FDA’s 

written comments and our response. FDA also provided technical 

comments, which we incorporated into the report as appropriate.)

FDA generally concurred that it should (1) verify that HACCP systems 

identify and control all hazards reasonably likely to occur; (2) emphasize to 

inspectors the need to revisit firms to observe actual product processing 

and establish a system to ensure that those visits occur; (3) develop 

milestones for completing its ongoing evaluation of methylmercury and 

determining whether it is a hazard reasonably likely to occur; (4) issue 

warning letters in a more timely manner; (5) develop baseline data, such as 

testing for a specific hazard, to measure the effectiveness of its seafood 

safety program; and (6) communicate HACCP system deficiencies 

identified during FDA importer inspections and foreign country inspections 

to port of entry personnel. 

FDA did not concur with our recommendation to require that all seafoodprocessing firms, including vessels, operate under HACCP requirements. 

FDA said that the vast majority of vessels currently exempt from the 
Page 36 GAO-01-204 Federal Oversight of Seafood

HACCP requirements conduct limited processing on board, making it 

unlikely that they would introduce significant food safety hazards that need 

to be controlled. While FDA’s comments provide additional information on 

the agency’s position on this issue, we continue to believe that our 

recommended action is warranted. Numerous fishing vessels handle highrisk products, such as tuna, which if not kept at appropriate temperatures, 

can result in foodborne illness. Absent a comprehensive inventory of all 

seafood-processing operations, including those on board vessels, FDA is 

unable to ensure that the HACCP system for identifying and controlling 

hazards is uniformly and consistently applied. If upon reviewing a vessel’s 

operation, FDA determines that food safety hazards are not reasonably 

likely to occur, FDA may decide that a HACCP plan is not required for that 

vessel. Furthermore, seafood processors and vessels that are not exempted 

from HACCP requirements are required to establish and implement a 

written sanitation standard operating procedure. Therefore, bringing 

vessels under the HACCP regulatory requirements would require them to 

have written sanitation operating procedures, even if FDA determined they 

do not need a HACCP plan. 

FDA also did not concur with our recommendation that the agency develop 

specific goals and time frames for establishing equivalence agreements 

while Congress considers mandating the certification of other countries’ 

equivalence before their seafood products are allowed entry into the 

United States. In commenting on this recommendation, FDA noted that 

foreign equivalencies is one of its priorities for fiscal year 2001, but said 

that a considerable exchange of data among the countries involved must 

take place before equivalency determinations can be made. We continue to 

believe, however, that this recommendation has merit for a variety of 

reasons. First, without goals and time frames, there is little or no incentive 

to complete equivalence agreements. For example, FDA and the Canadian 

Food Inspection Agency have had discussions and have engaged in 

activities aimed at determining equivalence of the two countries’ systems 

for over 3-1/2 years, since Canada first requested such action in 1997. 

Second, importers are responsible for ensuring that imported seafood 

meets HACCP requirements either by importing from countries with an 

equivalence agreement or by providing documentary support. However, 

because FDA has no equivalence agreements, seafood importers must use 

the more difficult and costly alternative of providing documentary support. 

Finally, it is generally recognized that establishing equivalence agreements 

with countries that have comparable safety and sanitation systems is the 

most effective way to ensure the safety of imported food. Equivalence 

agreements will help FDA reduce its reliance on importer and port of entry 
Page 37 GAO-01-204 Federal Oversight of Seafood

inspections and enable it to leverage its staff resources by sharing the 

responsibility for seafood safety with the exporting countries. Establishing 

goals and time frames will help FDA measure its progress toward obtaining 

such agreements and assist Congress in determining when to mandate that 

FDA certify an exporting countries equivalence, if Congress decides to do 

so. 

We conducted our review from February through December 2000 in 

accordance with generally accepted government auditing standards. 

As agreed with your offices, unless you publicly announce its contents 

earlier, we plan no further distribution of this report until 30 days from the 

date of this letter. At that time, we will send copies to congressional 

committees with jurisdiction over food safety issues; the Embassies of 

Canada and Chile; the Secretary of Agriculture; the Secretary of Health and 

Human Services; the Director, Office of Management and Budget; and other 

interested parties. We will make copies available to others on request.

If you have any questions about this report, please contact me at (202) 512-

3841. Major contributors to this report are listed in appendix V.

Lawrence J. Dyckman

Director, Natural Resources

 and Environment 
Page 38 GAO-01-204 Federal Oversight of Seafood

Appendix I

Scope and Methodology ApApenednxidexiIs

As you requested, we evaluated the Food and Drug Administration’s (FDA) 

system to better control the risk of foodborne illness resulting from unsafe 

domestic and imported seafood. As agreed with your office, we excluded 

molluscan shellfish (mussels, clams, oysters, and roe-on scallops) from this 

review because those products are regulated under a different regulatory 

structure. A separate GAO report will address federal efforts to ensure the 

safety of those products.

To obtain FDA’s views on its program for domestic and imported seafood, 

we interviewed cognizant government and industry officials. Specifically, 

we interviewed officials and/or reviewed documents from FDA’s Center for 

Food Safety and Applied Nutrition, Office of Seafood; Office of Regulatory 

Affairs; Office of Enforcement, Division of Compliance Policy; and Division 

of Import Operations and Policy. To obtain industry’s views on the Hazard 

Analysis and Critical Control Point (HACCP) system for seafood and FDA’s 

oversight of seafood firms, we also met with the National Fisheries 

Institute—a seafood trade association whose membership includes 

domestic and international firms. To learn about other HACCP regulatory 

systems, we interviewed U.S. Department of Agriculture (USDA) officials 

to discuss their implementation of a HACCP system for meat and poultry 

and the performance data requirements associated with that program. 

To assess FDA’s system for ensuring the safety of domestic seafood, we 

visited three of the FDA districts where large volumes of seafood are 

processed—Florida, New England, and Seattle—and met with officials to 

discuss relevant regulations, policies, and procedures. We also visited 

seafood firms to observe FDA’s seafood inspections first-hand and met with 

seafood industry personnel in the three districts, including officials and 

members of the National Food Processors Association. We also 

participated in the HACCP training course on seafood offered by the 

Seafood HACCP Alliance.

We analyzed 97 FDA inspections of domestic seafood products as recorded 

on FDA’s Form 3501 for fiscal year 1999. They were randomly selected from 

all 3501 forms in the three districts for fiscal year 1999. Table 3 shows our 

sampling plan for the three districts. We also analyzed 227 seafood warning 

letters issued nationwide during calendar years 1998 and 1999 and through 

the first 4 months of calendar year 2000 to assess the time frames for 

issuing warning letters and other pertinent information. Of these 227 

warning letters, 162 were issued to domestic processors after inspections 

conducted in fiscal year 1999. In recognition of FDA’s time frames that 

allow 30 working days for FDA to process a warning letter, we did not 
Appendix I

Scope and Methodology

Page 39 GAO-01-204 Federal Oversight of Seafood

consider any warning letter that was issued within 45 calendar days after 

the date of the inspection to have exceeded the issuance time frames.

Table 3: Sampling Plan for Three FDA Districts, Fiscal Year 1999

Since we used a sample (called a “probability sample”) of 97 inspection 

forms to develop our estimates of inspections in the three districts we 

visited, each estimate has a measurable precision, or sampling error, that 

may be expressed as a plus/minus figure. A sampling error indicates how 

closely we can reproduce from a sample the results that we could obtain if 

we were to take a complete count of the universe by using the same 

measurement methods. By adding the sampling error to and subtracting it 

from the estimate, we can develop upper and lower bounds for each 

estimate. This range is called a “confidence interval.” Sampling errors and 

confidence intervals are stated at a certain confidence level—in this case, 

95 percent. For example, a confidence interval at the 95-percent confidence 

level means that in 95 out of 100 instances, the sampling procedure we used 

would produce a confidence interval containing the universe value that we 

are estimating.

Table 4 shows sampling errors for selected estimates used in this report. 

Because we report subsets of the 97 inspections, such as only the products 

with HACCP plans, sampling errors are larger than they would be if we 

reported estimates based on the entire 97 inspection reports. Sampling 

errors range from 7 to 14 percent at the 95-percent confidence level. 

District’s name Number of inspections

Number of inspections

sampled

Florida 404 29

Seattle 633 36

New England 374 32

Total 1,411 97
Appendix I

Scope and Methodology

Page 40 GAO-01-204 Federal Oversight of Seafood

Table 4: Sampling Errors for Selected Estimates for Three District Offices, Fiscal Year 1999

Table 5 shows sampling errors for four subgroups used in table 4.

Table 5: Sampling Errors for Selected Subgroups for Three District Offices, Fiscal Year 1999

We also visited two of the leading seafood exporters to the United States—

Canada and Chile—to (1) obtain an understanding of their rules and 

Products Estimated percentage

Sampling

error

All products 

Products that did not need HACCP plans 32 ±9 percent

Products inspected on 1999 version of Form 3501

Products not being processed on the day of inspection 48 ±14 percent

Products with a HACCP plan

Products with at least one violation found 55 ±13 percent

Products not identifying hazards that were reasonably likely to occur 16 ±8 percent

Products with a HACCP plan and inspected on 1999 version of Form 3501

Products with inadequate identification of critical control points 21 ±5 percent

Products with a HACCP plan 

Products with inadequate identification of critical limits 23 ±11 percent

Products with inadequate written monitoring procedures 16 ±9 percent

Products with inadequate implementation of monitoring 21 ±10 percent

Products with inadequate identification of corrective actions 21 ±11 percent

Products with inadequate corrective actions 12 ±8 percent

Products with inadequate monitoring records 31 ±11 percent

Products with inadequate corrective action records 9 ± 7 percent

Products with a HACCP plan that had a valid answer to question on instrument calibration

Products that did not calibrate instruments properly 30 ±12 percent

Products

Estimated

 percentage

Sampling

error

Products inspected on 1999 version of Form 3501 51 ±10 percent

Products with a HACCP plan 60 ±10 percent

Products with a HACCP plan and inspected on 1999 version of Form 3501 28 ±9 percent

Products with a HACCP plan that had a valid answer to question on instrument 

calibration

54 ±10 percent
Appendix I

Scope and Methodology

Page 41 GAO-01-204 Federal Oversight of Seafood

regulations, (2) compare those countries’ seafood safety programs with the 

U.S. program, and (3) observe how those countries implement their safety 

rules and regulations for seafood. 

To assess FDA’s system for imported seafood, we (1) examined the status 

of FDA’s equivalence determinations with leading exporters of seafood to 

the United States and (2) reviewed and compared USDA and FDA 

authorities regarding equivalence determinations. We also analyzed FDA’s 

foreign country seafood inspection reports for fiscal year 1999 for the four 

countries visited—Ecuador, Vietnam, Taiwan, and the Philippines. We 

compared FDA’s findings during those foreign inspections with FDA’s 

actions at U.S. ports of entry. We also obtained and analyzed all of FDA’s 

records of importers’ inspections for fiscal year 1999 (3502 forms) and 

verified with FDA officials that FDA inspectors were adequately trained 

and did not encounter difficulties when completing these forms. Finally, we 

compared and contrasted selected aspects of FDA’s HACCP system for 

seafood with those of Canada and Chile.

We conducted our review from February through December 2000 in 

accordance with generally accepted government auditing standards.
Page 42 GAO-01-204 Federal Oversight of Seafood

Appendix II

Seafood-Related Illnesses ApendxiI

Seafood-related microbiological, chemical, and physical hazards can cause 

illnesses. According to the Centers for Disease Control and Prevention's 

(CDC) data, in 1997, the leading causes of seafood-related outbreaks were 

two natural toxins—ciguatoxin (42 percent of all outbreaks) and 

scombrotoxin (46 percent of all outbreaks). Table 6 summarizes some 

seafood-related hazards and the illnesses they cause.

Table 6: Selected Illnesses Caused by Seafood and Seafood Products

Agent Illness Symptoms Primary products

Clostridium botulinum Foodborne botulism Gastroentiritis, weakness, vertigo, 

and blurred vision. Can lead to 

respiratory failure and airway 

obstruction. Death among 

untreated patients up to 70 percent 

of cases.

Semipreserved fish products, including smoked, 

salted, and fermented fish.

Listeria 

monocytogenes

Listeriosis Can cause meningitis, septicemia, 

and perinatal disease. Fatality rate 

can be as high as 70 percent.

Ready-to-eat products, such as crabmeat and 

smoked fish.

Salmonella Salmonellosis Nausea, vomiting, cramps, 

diarrhea, fever, and headache. 

Death is possible in people with 

weakened immune systems.

Any fish products.

Ciguatera toxin Ciguatera poisoning Gastrointestinal symptoms, such as 

diarrhea, nausea, vomiting, and 

abdominal pain and neurological 

symptoms, dizziness, and blurred 

vision.

Any fish caught in tropical reef and island waters, 

but most common in amberjack, barracuda, 

snapper, grouper, and reef fish. 

Scombroid toxin Scombroid 

poisoning

Itching, redness, allergic symptoms, 

headache, diarrhea, and peppery 

taste.

Most common in mahi-mahi, tuna, bluefish, 

mackerel, and skipjack.

Methylmercury Methylmercury 

poisoning

Most dangerous for fetuses and 

infants: symptoms include mental 

retardation, cerebral palsy, 

deafness, and blindness. Adult 

symptoms may include numbness, 

tunnel vision, impaired hearing, 

muscle weakness, headache, 

irritability, and inability to 

concentrate.

Nearly all fish products. Highest concentrations are 

found in large fish, such as swordfish, shark, and 

tuna.
Page 43 GAO-01-204 Federal Oversight of Seafood

Appendix III

Seafood Safety Programs in the United States, 

Canada, and Chile ApendxiI

The United States, Canada, and Chile have adopted HACCP-based seafood 

inspection programs to ensure the safety of their seafood products. As 

summarized in table 7, the programs differ in several ways. 

Table 7: Characteristics of the Seafood Safety Program in the United States, Canada, 

and Chile

a

HAACP applies to exporters only.

b

Exporters only.

The following sections discuss the inspection programs of Canada and 

Chile only.

Canada’s Seafood 

Safety Program

To ensure the safety of its domestic seafood, Canadian officials said that in 

1992, Canada adopted a HACCP-based system that encompasses safety and 

quality. In 1996, the Canadian Food Inspection Agency and industry formed 

a task force to further study and improve the system. The resulting Quality 

Management Program (QMP) requires that all seafood companies develop, 

maintain, and implement comprehensive quality and safety plans. Seafood 

companies are required to register with the inspection agency, and each 

processor’s QMP plan must include the following:

• Management roles and responsibilities, which may include a written 

description of each manager’s accountability or a written statement of 

commitment signed by all management staff.

• Product and process information that includes product descriptions and 

processing steps.

Program features United States Canada Chilea

Industry required to register with 

oversight agency 

No Yes Yesb

Written hazard analysis required No Yes Yes

Written HACCP plan required Yes Yes Yes

Preimplementation review of HACCP 

plans

No Yes Yes

Required HACCP training for industry Yes No Yes

Sanitation requirements Yes Yes Yes

Frequency of federal inspections At least once 

per year

Quarterly Every 2 to 3 

months
Appendix III

Seafood Safety Programs in the United 

States, Canada, and Chile

Page 44 GAO-01-204 Federal Oversight of Seafood

• A prerequisite plan that addresses facilities design; construction; 

maintenance; and all potential sources of contamination, including 

employee hygiene; and company recall procedures.

• A regulatory action point plan that describes controls designed to 

ensure that the products meet fish inspection regulations addressing 

tainted, decomposed or unwholesome products, packaging materials 

and ingredients, and labeling requirements.

• A HACCP plan identifying and addressing any health and safety hazards 

related to the product or process by applying the seven HACCP 

principles.

• Steps for verifying and maintaining the QMP plan.

The inspection agency reviews the QMP plans, including HACCP plans, 

before they are put into effect by seafood firms. A written hazard analysis is 

part of the required documentation. Once the plan is implemented, the 

inspection agency conducts in-depth audits of the QMP’s implementation. 

For imported seafood products, Canada adopted a two-tier regulatory 

system. Importers that have a regular license can import seafood products 

from any country but must notify the inspection agency within 48 hours of 

the product’s entry. Depending on the product’s history, the inspection 

agency decides whether to detain the product for visual examination 

and/or testing. Inspection agency officials stated that, on average, they test 

about 15 percent of all imported seafood in this category. Alternatively, 

importers may voluntarily participate in the QMP for Importers. The 

program allows seafood importers to develop their own system for 

monitoring and evaluating products that they import while the inspection 

agency conducts quarterly audits of participating companies to ensure 

compliance with seafood safety standards. Importers must perform or have 

performed product testing at a minimum frequency of 15 percent or as 

otherwise established in Canadian agreements with other countries. The 

inspection agency has also provided an incentive for importers to obtain 

products from foreign companies that have a good history of compliance. 

Under this arrangement, foreign seafood firms with a good compliance 

record are considered for reduced inspection frequencies at an importer’s 

request. If approved, they are incorporated in the “A” list. To be part of this 

list, a foreign seafood firm must, at a minimum, have 10 acceptable 

inspections from at least 30 imported lots of seafood. Firms on the “A” list 

are subjected to unannounced inspections at predetermined frequencies.
Appendix III

Seafood Safety Programs in the United 

States, Canada, and Chile

Page 45 GAO-01-204 Federal Oversight of Seafood

Chile’s Seafood Safety 

Program

In 1994, Chile implemented a HACCP-based inspection program for 

seafood to improve the effectiveness of its seafood exporters’ certification 

program and to respond to future requirements of Chile’s major export 

markets—the European Union (Directive 91/493/CEE) and the United 

States. The Chilean National Seafood Service (Servicio Nacional de Pesca, 

Sernapesca) administers Chile’s seafood safety program. Chilean officials 

said that the HACCP system in Chile is modeled after the U.S. National 

Marine Fisheries Service System and Canadian systems. Therefore, it 

incorporates sanitation, safety, and quality features. Seafood exporters, 

including factory vessels, must be registered and authorized to export 

through the certification program. It is illegal to operate without registering 

with Sernapesca. In order to receive an export certification, exporters must 

implement the HACCP requirements. 

Sernapesca issued procedures manuals, technical norms, and inspection 

instructions. Together, these documents instruct industry and inspectors 

on how to review and validate HACCP plans, how to collect official 

samples, and how to conduct objective inspections. Sernapesca must 

review and approve HACCP plans. Seafood exporters are required to 

maintain a written hazard analysis plan and to have it available for 

inspection. Officials think it is important to know the reasoning for 

inclusion or exclusion (in the HACCP plans) of hazards reasonably likely to 

occur.

Sernapesca conducts monthly sanitation inspections of seafood exporters. 

If the exporter fails the sanitation inspection, it is removed from 

Sernapesca’s approved exporter list and thus can no longer receive export 

certification. Vessels are inspected when they come into port—every 3 

months on average. Seafood firms are instructed to conduct biweekly 

verifications of their HACCP systems, and Sernapesca inspects firms once 

every 2 to 3 months, depending on the product. After inspection, firms are 

classified I through IV, depending on the number of deficiencies observed 

by inspectors. These categories determine whether firms will continue to 

be certified.
Page 46 GAO-01-204 Federal Oversight of Seafood

Appendix IV

Comments From the Food and Drug 

Administration ApendxiIV

Note: GAO’s comments 

supplementing those in the 

report text appear at the 

end of this appendix.
Appendix IV

Comments From the Food and Drug 

Administration

Page 47 GAO-01-204 Federal Oversight of Seafood
Appendix IV

Comments From the Food and Drug 

Administration

Page 48 GAO-01-204 Federal Oversight of Seafood
Appendix IV

Comments From the Food and Drug 

Administration

Page 49 GAO-01-204 Federal Oversight of Seafood

See comment 1.

See comment 2.
Appendix IV

Comments From the Food and Drug 

Administration

Page 50 GAO-01-204 Federal Oversight of Seafood

See comment 2.

See comment 3.
Appendix IV

Comments From the Food and Drug 

Administration

Page 51 GAO-01-204 Federal Oversight of Seafood

See comment 4.
Appendix IV

Comments From the Food and Drug 

Administration

Page 52 GAO-01-204 Federal Oversight of Seafood

See comment 5.

See comment 2.
Appendix IV

Comments From the Food and Drug 

Administration

Page 53 GAO-01-204 Federal Oversight of Seafood
Appendix IV

Comments From the Food and Drug 

Administration

Page 54 GAO-01-204 Federal Oversight of Seafood
Appendix IV

Comments From the Food and Drug 

Administration

Page 55 GAO-01-204 Federal Oversight of Seafood

See comment 5.
Page 56 GAO-01-204 Federal Oversight of Seafood

See comment 6.
Appendix IV

Comments From the Food and Drug 

Administration

Page 57 GAO-01-204 Federal Oversight of Seafood

The following are GAO’s comments on the Food and Drug Administration’s 

letter dated January 17, 2001.

GAO’s Comments 1. We modified our report to include the actual number of cases associated 

with seafood and with meat and poultry outbreaks. We also added CDC’s 

observation that reported illness outbreaks tend to be for illnesses more 

likely to be recognized. According to CDC, diagnosable illnesses, such as 

scombroid poisoning from seafood, are more easily recognized than 

illnesses from nonspecific gastrointestinal symptoms caused by other 

foods.

2. We believe that until FDA develops an inventory that identifies and 

assesses each vessel’s on-board activities, FDA’s view that vessels not 

performing functions beyond preparing the catch for holding pose little or 

no risks lacks credibility. Numerous fishing vessels handle high-risk 

products, such as tuna, which if not properly handled or held—kept at the 

appropriate temperature—may result in foodborne illness. Furthermore, 

although the number of vessels processing seafood on-board is unknown, 

federal and state officials’ estimates lead us to conclude that a significant 

number could be conducting on-board processing similar to that conducted 

by land-based seafood firms. Land-based seafood firms that head, 

eviscerate, and freeze products are required to comply with the HACCP 

regulations. Exempting vessels from the HACCP regulations also 

eliminates the requirement for a written standard operating procedure for 

sanitation aimed at ensuring basic sanitation procedures and practices. We 

modified the report to clarify the HACCP regulatory requirements for 

vessels.

With respect to FDA’s comments on domestic firms found not to need 

HACCP plans, we did not mean to suggest that all 1,055 of FDA’s 

determinations exempting products from needing HACCP plans were 

incorrect. We do question, however, whether FDA inspectors were justified 

in exempting as many as 516 of these products on the grounds that storage 

and repacking firms do not handle products presenting significant hazards. 

In our view, many of these firms handle products with significant hazards 

and should have HACCP plans. We did modify the report to include FDA’s 

view that frozen products do not present significant food safety risks.

3. We agree that since the publication of our 1998 report, FDA has initiated 

actions to improve controls over imported foods aimed at preventing 

unscrupulous importers from bypassing or subverting port-of-entry 
Appendix IV

Comments From the Food and Drug 

Administration

Page 58 GAO-01-204 Federal Oversight of Seafood

activities. However, the fact remains that without equivalence agreements, 

FDA has to rely on labor-intensive inspections of products at the port of 

entry as its primary line of defense against the entry of unsafe foods. We 

continue to believe that port-of-entry inspections alone do not effectively 

ensure the safety of imported seafood. Using port-of-entry inspections to 

augment a program certifying that imported products are produced under 

equivalent food safety systems is a much more efficient and effective way 

to ensure the safety of imported foods. Providing FDA with authority 

similar to that provided for the Food Safety and Inspection Service would 

allow FDA to leverage its resources and provide greater assurance that 

imported seafood is safe. Accordingly, we did not modify the report.

4. We agree with FDA’s comment that its efforts to gather and analyze 

seafood firms’ compliance with HACCP requirements have merit but 

continue to believe that compliance information alone is not a good 

indicator of the seafood program’s impact on reducing contamination that 

could cause foodborne illness. A performance-based measurement, such as 

that used by USDA, would improve FDA’s evaluation of the effectiveness of 

its programs for ensuring seafood safety. While there may not be any single 

widespread hazard in seafood, scombrotoxin and ciguatoxin caused 46 and 

42 percent of seafood illness outbreaks, respectively. Therefore, we 

continue to believe that FDA should identify the hazards of most concern 

(e.g., scombrotoxin), develop baseline information on such hazard(s), and 

use that information to assess the effectiveness of its programs in reducing 

the prevalence of such hazards. We modified the report to provide 

additional information regarding FDA’s compliance-based data.

5. We continue to believe that an emphasis on equivalence agreements by 

establishing goals and time frames is appropriate because equivalency is 

generally a more effective way to ensure the safety of imported food. 

Equivalence agreements will help FDA reduce its reliance on importer and 

port-of-entry inspections and enable it to leverage its staff resources by 

sharing the responsibility for seafood safety with the exporting countries. 

Goals and time frames are standard management tools used to monitor the 

progress of important initiatives, such as equivalence agreements. Without 

them, there is less incentive to complete the initiatives. In this regard, FDA 

and the Canadian Food Inspection Agency have had discussions and 

engaged in activities aimed at determining the equivalence of the two 

countries’ systems since Canada first requested such action in 1997. 

Furthermore, without any equivalence agreements for seafood, importers 

must use the more difficult and costly alternative of providing documentary 

support that the exporting seafood processor has a HACCP system that 
Appendix IV

Comments From the Food and Drug 

Administration

Page 59 GAO-01-204 Federal Oversight of Seafood

meets U.S. requirements. We also recommend that Congress consider 

mandating that FDA certify other countries’ equivalence before their 

seafood products are allowed entry into the United States. If Congress 

decides to act in this regard, we would envision that Congress would 

provide FDA a number of years to complete such determinations. By 

establishing goals and time frames for equivalence agreements, FDA would 

assist Congress in this effort. FDA could establish alternative provisions for 

countries that export seafood to the United States and have systems that 

are not equivalent, such as requiring them to provide laboratory tests or 

other assurances that the seafood meets U.S. standards.

See comment 2.

See comment 5.

6. We commend FDA for taking action to add foreign firms to its import 

alert list after we brought this issue to its attention. We modified the report 

to include this information. 
Page 60 GAO-01-204 Federal Oversight of Seafood

Appendix V

GAO Contacts and Staff Acknowledgments ApendxiV

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

Keith W. Oleson (415) 904-2218

Acknowledgments In addition to those named above, Maria Cristina Gobin, Randolph D. 

Jones, Leo Acosta, Roberto Pinero, Alicia Antonetti, Fran Featherston, 

Carol Herrnstadt Shulman, and Oliver Easterwood made key contributions 

to this report. 

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