Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect
Consumers (Letter Report, 01/31/2001, GAO/GAO-01-204).

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

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  GAO-01-204
     TITLE:  Food Safety: Federal Oversight of Seafood Does Not
	     Sufficiently Protect Consumers
      DATE:  01/31/2001
   SUBJECT:  Contaminated foods
	     Food inspection
	     Food industry
	     Health hazards
	     Food and drug legislation
	     Consumer protection
	     Safety standards
	     Import regulation
	     Fishing industry
IDENTIFIER:  FSIS Hazard Analysis and Critical Control Point System

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GAO-01-204

A

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

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

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

Lett er

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.

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.

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).

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).

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.

Biological, chemical, and physical hazards can cause seafood- related
illnesses. Biological hazards include clostridium botulinum, listeria
monocytogenes, salmonella, and pathogenic staphylococcus. Chemical hazards
include compounds such as methylmercury, which can cause illness from long-
term exposure. Physical hazards include foreign objects

in food that can cause harm when eaten, such as glass or metal fragments.
According to FDA officials, two naturally occurring marine toxins with
potentially serious health effects- scombrotoxin and ciguatoxin 8 -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.

Figure 1: Percentage of 1999 U. S. Seafood Imports from Major Exporting
Countries By volume 8%

China

6%

Ecuador

4%

Chile ?

?

15% ? 50% Other a

17% ?

Canada Thailand

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.

? Conduct a hazard analysis. Identify hazards that are reasonably likely to
occur. ? Identify the critical control points (CCPs). Identify a point,
step, or procedure in the production process where controls can be applied
to prevent, eliminate, or reduce a food safety hazard that is reasonably
likely to occur to an acceptable level. ? Establish critical limits for each
CCP. Set the maximum or minimum

value at which a hazard must be controlled at each CCP to prevent,
eliminate, or reduce the hazard to an acceptable level. ? Monitor each CCP.
Establish monitoring activities that will ensure that the process is under
control at each CCP. ? Establish corrective actions. Define actions to be
taken when

monitoring discloses a deviation from established critical limits. ?
Establish verification procedures. Establish verification procedures to

ensure that HACCP plans accomplish their intended goal- ensuring the
production of safe products. ? Establish record- keeping and documentation
procedures. Maintain

documentation, including the HACCP plan, CCP monitoring, critical limits,
and verification activities. Under the HACCP rule, seafood- processing firms
are responsible for conducting a hazard analysis and for developing and
implementing HACCP plans for hazards determined to be reasonably likely to
occur: natural toxins, microbiological contamination, chemical
contamination, pesticides, drug residues, decomposition in certain species,
parasites, unapproved use of food or color additives, and physical hazards.
For each hazard identified, the firms must establish critical control points
to prevent or reduce contamination. Firms must also establish and monitor
sanitation procedures to ensure, among other things, the (1) general
cleanliness of food contact surfaces, including utensils, gloves, and outer
garments, and

(2) control of employee health conditions. To assist industry with HACCP
compliance, FDA published the Fish and Fisheries Products Hazards and
Controls Guide, which discusses, among other things, how to perform a hazard
analysis, develop a HACCP plan, and identify critical control points. The
guide provides species- specific and process- related examples of hazards
reasonably likely to occur, but as its name suggests, this document is only
guidance; seafood firms are not required to follow it. The guide, according
to FDA, has been translated into other languages, is used by regulatory
authorities in other countries, and

has served as a catalyst for discussions between the seafood industry, other

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

According to the National Fisheries Institute, 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.

million increase over FDA's budget for fiscal year 1999. Some of this
increase was to enhance the coverage of both domestic and imported foods,
including the increased inspection of high- risk food and continued
implementation of the HACCP requirement for seafood. While FDA believes that
additional funds are needed to ensure the safety of the food supply, it now
inspects seafood firms annually. Prior to these annual inspections, FDA
inspected seafood firms once every 4 years on average, according to FDA
officials. Generally, FDA personnel inspect one or two seafood products at
each firm inspected. The number of seafood products handled by each firm
varies.

According to FDA, seafood- processing firms collectively handle over 350
species of fish. For example, the seafood firms that we visited in Norfolk
and Philadelphia processed a wide range of products, including fresh and
frozen fish, such as salmon, tuna, bluefish, mahi- mahi, mackerel, and
grouper; crustaceans, such as lobster and crabs; and shellfish, such as
oysters and clams. FDA's policy was to give priority to inspecting products
considered to be high- risk, including

? vacuumed- packaged seafood (these products are subject to the growth of
Clostridium botulinum, a toxin producing bacteria); ? ready- to- eat
seafood, such as cooked shrimp and crabmeat and hot or cold smoked fish
(these products are subject to the growth of pathogens from post- process
contamination);

? histamine- forming species, including mahi- mahi, tuna, and bluefish
(these products are subject to histamine formation- a toxic substance); and
? stuffed seafood products (processing and handling may allow toxins to

develop in these products). FDA can take several regulatory actions when
firms are cited for HACCP violations. For example, if in the agency's
judgment the violation cited is of regulatory significance, it may issue the
firm a warning letter. FDA issues warning letters in cases where violations
raise safety concerns that may

lead to enforcement action, such as product seizure or injunction (a court
order to refrain from distributing a product), and/ or prosecution if not
promptly and adequately corrected. In the case of importers, a warning
letter could advise them of a forthcoming detention. Firms that receive
warning letters are asked to respond to FDA in writing within 15 working
days to indicate what actions will be taken to correct the problems
identified. If the firm does not correct the violation promptly and

adequately, FDA can pursue enforcement actions, such as product seizure or
injunction through the courts.

In 1996, USDA issued HACCP regulations for meat and poultry firms. However,
before implementing HACCP, USDA established the prevalence, or baseline,
levels for a number of microbial organisms in meat and poultry, including
salmonella, E- coli, listeria, and campylobacter. These baseline

data provided USDA with a starting point for evaluating the effectiveness of
HACCP in terms of lowering the bacterial levels in the product. For example,
USDA regularly collects and tests samples of meat and poultry products for
the presence of salmonella and then compares the results with pre- HACCP
baseline data.

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

Safety System Does consumed by the public. According to FDA's December 2000
report on the evaluation of the HACCP system for seafood, the percentage of
seafood

Not Effectively Protect firms with a HACCP plan that included all of the
required components

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

From Unsafe Seafood recognizes that gaps still exist in HACCP's
implementation and that certain

segments of the industry are lagging behind. Our evaluation shows that
several flaws in FDA's system for ensuring the safety of domestic seafood
may allow unsafe seafood products to reach consumers. First, a significant
number of seafood firms and/ or products are not operating under the HACCP
regulations. Second, even when seafood- processing firms are

subject to HACCP requirements, FDA inspections do not fully evaluate the
firms' operations because such inspections were frequently limited to a
paperwork review rather than actual observation of product processing.
Furthermore, at both these inspections and those where FDA observed the
processing of products subject to HACCP requirements, the agency found that
over half of the HACCP plans had serious violations. Third, when violations
of regulatory significance were identified, FDA did not take

timely action to issue warning letters notifying seafood firms that they
must correct the violations promptly and adequately to avoid further
enforcement action, such as seizure or injunction. Finally, FDA lacks, and
has no immediate plans to obtain, the basic information needed to assess the
effectiveness of its HACCP requirements to ensure the safety of seafood.

Many Seafood Firms Are HACCP regulations apply to all seafood- processing
firms, but a significant Excluded From HACCP

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

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

10 FDA'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).

11 See 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- 9287, Feb. 10, 1992).

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.

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.
12 In 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.

13 Fed. Reg. 4561 (Jan. 30, 1998).

FDA Is Not Effectively FDA uses on- site unannounced inspections to assess a
firm's compliance Ensuring HACCP

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

general sanitary conditions of the firm and equipment. Critical components
of the inspection also include an evaluation of HACCP plans, review of HACCP
records, and in- plant observations of the product selected for inspection.
However, we found that FDA inspectors frequently could not conduct in- plant
observations of the selected product. We estimate that in almost half (48
percent) of the seafood inspections at three FDA districts in fiscal year
1999, the selected product was not being processed on the day of the
inspection. In other words, FDA inspectors did not make an in- plant
observation of the product but instead conducted a paperwork review. FDA

officials said that because inspections are unannounced, there were
instances where the product selected was not being processed and FDA
inspectors were limited to a review of plant records to verify compliance.
FDA's compliance manual recommends that inspectors return to physically
inspect the product if at the time of their plant visit, the product was not
being processed. However, FDA inspectors generally did not return to the
firm to inspect the products originally selected for inspection. Officials
in the three districts we visited said that, as a general rule, insufficient
inspection resources prevent them from returning to observe the selected

product. FDA inspection records did not show such follow- up inspections,
and FDA inspectors told us they did not conduct them. In an October 1999
memorandum to FDA District Directors, FDA acknowledged the need to observe
the selected product during processing by stating that HACCP

inspections emphasized the need for more in- plant observations of the
selected products. An FDA official explained that inspectors should spend
most of their inspection time observing the selected product in the
processing environment, especially those that are considered high- risk.

In addition, almost 3 years after HACCP was implemented, FDA's data on
industry compliance shows that many seafood firms have yet to meet the basic
requirements for a HACCP plan. That is, 22 percent (542 of 2,470) of the
products inspected by FDA in 1999 that required a HACCP plan did not have
one. 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
14 FDA reviews only one or two product types during an inspection, although
some firms produce more than two types.

15 Detailed 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.

16 The 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.

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

Estimated percentage of Type of violation occurrences a

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 21 procedures Inadequate identification of corrective action 21

procedures Inadequate corrective actions 12 Inadequate monitoring records 31
Inadequate corrective actions records 9 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

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.

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

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 FDA lacks objective, measurable data
to determine whether its HACCP Assess the Effectiveness of

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

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

18 FDA 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.

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 As with domestic products, FDA's approaches for ensuring
the safety of Ensuring the Safety of

imported seafood provide only limited protection against unsafe seafood
reaching consumers. First, FDA has been unable to develop equivalence or
Imported Seafood Are compliance agreements that document foreign countries'
equivalence or Not Effective

compliance with the U. S. seafood safety system. Second, FDA's reviews of
importers' documentation have shown that many do not have records of foreign
seafood firms' compliance with U. S. requirements for HACCP programs as is
required in the absence of equivalence agreements. When documentation has
been available, it often did not adequately demonstrate such compliance.
Third, although FDA inspects some foreign firms and

often finds serious deficiencies, it does not take follow- up actions, such
as automatically detaining products from these firms at U. S. ports. Fourth,
FDA's traditional strategy of visually examining and/ or testing imported

seafood at U. S. ports has been widely discredited as an effective method
for ensuring the safety of imported foods. Moreover, FDA's port of entry
examinations and testing are unable to keep pace with the growing level of
imports. FDA Lacks Country- toCountry

FDA has authority to enter into voluntary agreements with individual
Equivalence countries recognizing the equivalence or compliance of their
seafood safety Agreements 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

19 See article 4, Agreement on the Application of Sanitary and Phytosanitary
Measures, World Trade Organization Agreement, 1994. 20 Compliance 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.

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

21 See GAO/ RCED- 98- 103.

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

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

and foreign countries, federal regulations hold importers responsible for
Demonstrate Compliance demonstrating that the seafood they bring into the
United States is With HACCP Requirements 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.

Figure 2: Importers' Regulatory and Compliance Requirements

Regulations require that importers meet 1 of 2 conditions (A or B)

A B

Importer purchases seafood from country

(1) a written product with an equivalency

specification is on file agreement with FDA

Importer cannot and

use this option because there are no seafood agreements

(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

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 document 23 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. 22 To 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).

23 Written product specifications are designed to ensure that the product is
not adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act. 24 The 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.

? 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.

25 The 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).

FDA Does Not Take FDA conducts limited inspections of selected foreign
seafood firms to Enforcement Actions on determine the firms' compliance with
the agency's seafood regulations. 27 Deficiencies Identified in Its

FDA personnel visited four foreign countries in fiscal year 1999- Ecuador,
Overseas Inspections

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 Number of FDA Number of

warning letters and Countries firms

foreign firm Visited

inspected responses a Examples of problems found

Ecuador 10 Six warning letters No HACCP plan. issued- three responses
received

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 HACCP plan did not identify potential histamine
hazards in scombroid issued- one response species.

received HACCP plan did not address aquaculture drugs or environmental
chemical hazards. 27 FDA's criteria for selecting foreign firms includes
previous compliance problems and the volume of seafood exported to the
United States.

(Continued From Previous Page)

Number of FDA Number of

warning letters and Countries firms

foreign firm Visited

inspected responsesa Examples of problems found

Philippines 9 Nine warning letters HACCP plan did not list hazards, critical
limits, and monitoring issued- three procedures.

responses received Monitoring controls for critical control points were
nonexistent or inconsistent, and corrective actions were inappropriate.

Vietnam 8 Eight warning letters Processor did not have records to indicate
that scombroid species were issued- six responses

histamine- free. received

HACCP plan did not identify aquaculture drugs and environmental chemical
hazards. 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 FDA may detain individual shipments at U. S. ports
of entry so it can

Are Widely Discredited conduct visual examinations and/ or collect and test
product samples while

it determines if the product is misbranded or adulterated. However, port of
entry inspections for imported food have been widely discredited as an
effective means for ensuring product safety. Furthermore, FDA's port of
entry examinations have been unable to keep pace with the growing volume of
seafood product imported into the United States.

According to the U. N. Food and Agriculture Organization, testing products
at the port of entry involves a concentration of inspection resources on the
imported product itself and is an attempt to compensate for a lack of
knowledge about the producer's processing, hygiene, and sanitation
practices. Recognizing the limitations of this method, FDA's draft guidance
on equivalence criteria states that, by itself, the end- product inspection
and testing at the port of entry cannot be relied upon to provide adequate
protection. In our 1998 report on imports, we also reported that reliance on
end- product testing is an ineffective, resource- intensive, and
statistically invalid approach to ensuring the safety of imported food. We
made a number of recommendations to improve the effectiveness of FDA's port
of entry- inspection system, such as providing inspectors with more
consistent and accurate data for selecting imported products for inspection
but emphasized that FDA's reliance on port of entry inspections was an

ineffective means for ensuring the safety of imported food. Therefore, to
strengthen FDA's ability to ensure the safety of imported food, we
recommended that Congress require all food eligible for importation to the
United States- not just meat and poultry- be produced under equivalent food
safety systems. 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

28 See GAO/ RCED- 98- 103, and Food Safety: Changes Needed to Minimize
Unsafe Chemicals in Food (GAO/ RCED- 94- 192, Sept. 26, 1994).

effectiveness of the federal seafood safety system. If left uncorrected,
they will continue to undermine the goal of HACCP systems- that is,
controlling hazards in the production process before the product reaches the
market. More importantly, U. S. consumers may continue to be placed at risk
of contracting foodborne illness from contaminated domestic and imported
seafood products.

Without requiring registration of all domestic seafood firms, FDA cannot
effectively ensure that all seafood products are processed under the HACCP
regulations. Similarly, FDA cannot ensure that all seafood products are
operating under HACCP systems if it continues to exclude vessels that meet
its criteria for land- based seafood firms. Unless FDA verifies that
industry identifies and controls all hazards reasonably likely to occur, it
cannot ensure that industry is implementing an effective HACCP system.

And without the actual observation of the seafood products selected for
inspection, FDA inspectors cannot ensure full compliance with HACCP
requirements. Also, without prompt completion of its ongoing evaluation of
methylmercury, FDA is unable to give direction to the industry on whether it
should establish HACCP controls for this hazard, thus potentially placing

consumers at risk of exposure to unsafe levels of methylmercury.
Furthermore, without FDA's timely notification to industry when deficiencies
are observed, serious problems are not corrected promptly. Finally, without
baseline data, such as that provided by regular microbial

testing, FDA is unable to measure the HACCP program's effectiveness and is
unable to identify when and where corrective actions are needed.

Concerning imports, FDA does not have seafood equivalence or compliance
agreements with any foreign country, which is one of the most effective
methods for ensuring the safety of imports. Lacking such agreements, FDA
must rely, in part, on a review of importers' records to ascertain that
imported products are processed under an acceptable HACCP system. However,
most importers have not had the required documentation to demonstrate that
the product offered for entry has been processed under HACCP controls. In
addition, by not communicating the results of foreign firms' inspections to
U. S. port of entry personnel, the likelihood that unsafe products from
these firms are not inspected prior to their release into the U. S. market
is increased. Finally, port of entry inspections are insufficient to ensure
the safety of imported seafood, are an inefficient use of resources, and
have been unable to keep pace with

increasing import shipments.

Matters for To strengthen FDA's ability to ensure that all domestic seafood
products

Congressional are processed under HACCP requirements, the Congress should
provide

FDA with comprehensive authority to require the registration of all
Consideration 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 To better
ensure the safety of domestic and imported seafood consumed in Executive
Action

the United States, we recommend that the Commissioner of FDA ? require that
all seafood- processing firms, including vessels that meet FDA's HACCP
criteria for land- based seafood firms, operate under HACCP requirements;

? conduct in- depth audits of seafood firms that operate HACCP systems to
verify that they identify and control all hazards reasonably likely to
occur; ? emphasize to inspectors the need to revisit firms to observe the

processing of seafood product( s) selected for inspection as required by
FDA's compliance manual and establish a system to monitor inspections to
ensure that such revisits occur;

? develop milestones for completing the agency's ongoing evaluation of
methylmercury and determine whether it is a seafood hazard reasonably likely
to occur;

? issue warning letters within FDA's required time frames; ? develop
baseline information, such as regular microbial test results, and

use it to assess the effectiveness of HACCP systems over time; ? develop
specific goals and time frames for establishing equivalence

agreements while Congress considers whether to mandate FDA's certification
of other countries' equivalence before their seafood products are allowed
entry into the United States; and

? communicate HACCP system deficiencies identified during FDA's importer
inspections and foreign country inspections to port of entry personnel so
that potentially contaminated imported seafood is examined before being
allowed tothe United States.

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

Our Evaluation 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

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

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

Appendi Appendi xes x I

Scope and Methodology As you requested, we evaluated the Food and Drug
Administration's (FDA) system to better control the risk of foodborne
illness resulting from unsafe domestic and imported seafood. As agreed with
your office, we excluded molluscan shellfish (mussels, clams, oysters, and
roe- on scallops) from this review because those products are regulated
under a different regulatory

structure. A separate GAO report will address federal efforts to ensure the
safety of those products. To obtain FDA's views on its program for domestic
and imported seafood, we interviewed cognizant government and industry
officials. Specifically, we interviewed officials and/ or reviewed documents
from FDA's Center for Food Safety and Applied Nutrition, Office of Seafood;
Office of Regulatory Affairs; Office of Enforcement, Division of Compliance
Policy; and Division of Import Operations and Policy. To obtain industry's
views on the Hazard

Analysis and Critical Control Point (HACCP) system for seafood and FDA's
oversight of seafood firms, we also met with the National Fisheries
Institute- a seafood trade association whose membership includes domestic
and international firms. To learn about other HACCP regulatory systems, we
interviewed U. S. Department of Agriculture (USDA) officials to discuss
their implementation of a HACCP system for meat and poultry

and the performance data requirements associated with that program. To
assess FDA's system for ensuring the safety of domestic seafood, we visited
three of the FDA districts where large volumes of seafood are processed-
Florida, New England, and Seattle- and met with officials to discuss
relevant regulations, policies, and procedures. We also visited seafood
firms to observe FDA's seafood inspections first- hand and met with seafood
industry personnel in the three districts, including officials and members
of the National Food Processors Association. We also participated in the
HACCP training course on seafood offered by the Seafood HACCP Alliance.

We analyzed 97 FDA inspections of domestic seafood products as recorded on
FDA's Form 3501 for fiscal year 1999. They were randomly selected from all
3501 forms in the three districts for fiscal year 1999. Table 3 shows our
sampling plan for the three districts. We also analyzed 227 seafood warning
letters issued nationwide during calendar years 1998 and 1999 and through
the first 4 months of calendar year 2000 to assess the time frames for
issuing warning letters and other pertinent information. Of these 227
warning letters, 162 were issued to domestic processors after inspections
conducted in fiscal year 1999. In recognition of FDA's time frames that
allow 30 working days for FDA to process a warning letter, we did not

consider any warning letter that was issued within 45 calendar days after
the date of the inspection to have exceeded the issuance time frames.

Table 3: Sampling Plan for Three FDA Districts, Fiscal Year 1999 Number of
inspections District's name Number of inspections sampled

Florida 404 29

Seattle 633 36

New England 374 32 Tot al 1,411 97

Since we used a sample (called a “probability sample”) of 97
inspection forms to develop our estimates of inspections in the three
districts we visited, each estimate has a measurable precision, or sampling
error, that may be expressed as a plus/ minus figure. A sampling error
indicates how

closely we can reproduce from a sample the results that we could obtain if
we were to take a complete count of the universe by using the same
measurement methods. By adding the sampling error to and subtracting it from
the estimate, we can develop upper and lower bounds for each estimate. This
range is called a “confidence interval.” Sampling errors and
confidence intervals are stated at a certain confidence level- in this case,
95 percent. For example, a confidence interval at the 95- percent confidence
level means that in 95 out of 100 instances, the sampling procedure we used
would produce a confidence interval containing the universe value that we
are estimating.

Table 4 shows sampling errors for selected estimates used in this report.
Because we report subsets of the 97 inspections, such as only the products
with HACCP plans, sampling errors are larger than they would be if we
reported estimates based on the entire 97 inspection reports. Sampling
errors range from 7 to 14 percent at the 95- percent confidence level.

Table 4: Sampling Errors for Selected Estimates for Three District Offices,
Fiscal Year 1999 Sampling Products Estimated percentage error

All products Products that did not need HACCP plans 32 ï¿½ 9 percent Products
inspected on 1999 version of Form 3501 Products not being processed on the
day of inspection 48 ï¿½ 14 percent

Products with a HACCP plan

Products with at least one violation found 55 ï¿½ 13 percent Products not
identifying hazards that were reasonably likely to occur 16 ï¿½ 8 percent
Products with a HACCP plan and inspected on 1999 version of Form 3501
Products with inadequate identification of critical control points 21 ï¿½ 5
percent

Products with a HACCP plan

Products with inadequate identification of critical limits 23 ï¿½ 11 percent
Products with inadequate written monitoring procedures 16 ï¿½ 9 percent
Products with inadequate implementation of monitoring 21 ï¿½ 10 percent
Products with inadequate identification of corrective actions 21 ï¿½ 11
percent Products with inadequate corrective actions 12 ï¿½ 8 percent Products
with inadequate monitoring records 31 ï¿½ 11 percent Products with inadequate
corrective action records 9 ï¿½ 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 ï¿½ 12 percent

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 Estimated

Sampling Products percentage error

Products inspected on 1999 version of Form 3501 51 ï¿½ 10 percent Products
with a HACCP plan 60 ï¿½ 10 percent Products with a HACCP plan and inspected
on 1999 version of Form 3501 28 ï¿½ 9 percent Products with a HACCP plan that
had a valid answer to question on instrument

54 ï¿½ 10 percent calibration We also visited two of the leading seafood
exporters to the United States-

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

regulations, (2) compare those countries' seafood safety programs with the
U. S. program, and (3) observe how those countries implement their safety
rules and regulations for seafood. To assess FDA's system for imported
seafood, we (1) examined the status

of FDA's equivalence determinations with leading exporters of seafood to the
United States and (2) reviewed and compared USDA and FDA authorities
regarding equivalence determinations. We also analyzed FDA's foreign country
seafood inspection reports for fiscal year 1999 for the four countries
visited- Ecuador, Vietnam, Taiwan, and the Philippines. We compared FDA's
findings during those foreign inspections with FDA's actions at U. S. ports
of entry. We also obtained and analyzed all of FDA's

records of importers' inspections for fiscal year 1999 (3502 forms) and
verified with FDA officials that FDA inspectors were adequately trained and
did not encounter difficulties when completing these forms. Finally, we
compared and contrasted selected aspects of FDA's HACCP system for seafood
with those of Canada and Chile.

We conducted our review from February through December 2000 in accordance
with generally accepted government auditing standards.

Appendi x II

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

Table 6: Selected Illnesses Caused by Seafood and Seafood Products Agent
Illness Symptoms Primary products

Clostridium botulinum Foodborne botulism Gastroentiritis, weakness, vertigo,
Semipreserved fish products, including smoked, and blurred vision. Can lead
to salted, and fermented fish. respiratory failure and airway obstruction.
Death among untreated patients up to 70 percent

of cases. Listeria Listeriosis Can cause meningitis, septicemia,

Ready- to- eat products, such as crabmeat and monocytogenes and perinatal
disease. Fatality rate smoked fish. can be as high as 70 percent. Salmonella
Salmonellosis Nausea, vomiting, cramps,

Any fish products. diarrhea, fever, and headache. Death is possible in
people with weakened immune systems.

Ciguatera toxin Ciguatera poisoning Gastrointestinal symptoms, such as Any
fish caught in tropical reef and island waters, diarrhea, nausea, vomiting,
and

but most common in amberjack, barracuda, abdominal pain and neurological

snapper, grouper, and reef fish. symptoms, dizziness, and blurred vision.

Scombroid toxin Scombroid Itching, redness, allergic symptoms, Most common
in mahi- mahi, tuna, bluefish, poisoning headache, diarrhea, and peppery
mackerel, and skipjack.

taste. Methylmercury Methylmercury Most dangerous for fetuses and Nearly all
fish products. Highest concentrations are poisoning infants: symptoms
include mental

found in large fish, such as swordfish, shark, and retardation, cerebral
palsy, tuna. deafness, and blindness. Adult symptoms may include numbness,
tunnel vision, impaired hearing, muscle weakness, headache, irritability,
and inability to concentrate.

Seafood Safety Programs in the United States,

Appendi x II I Canada, and Chile The United States, Canada, and Chile have
adopted HACCP- based seafood inspection programs to ensure the safety of
their seafood products. As summarized in table 7, the programs differ in
several ways. Table 7: Characteristics of the Seafood Safety Program in the
United States, Canada, and Chile Program features United States Canada Chile
a Industry required to register with

No Yes Yes b oversight agency Written hazard analysis required No Yes Yes
Written HACCP plan required Yes Yes Yes Preimplementation review of HACCP No
Yes Yes plans Required HACCP training for industry Yes No Yes

Sanitation requirements Yes Yes Yes Frequency of federal inspections At
least once Quarterly Every 2 to 3 per year months

a HAACP applies to exporters only. b Exporters only.

The following sections discuss the inspection programs of Canada and Chile
only.

Canada's Seafood To ensure the safety of its domestic seafood, Canadian
officials said that in

Safety Program 1992, Canada adopted a HACCP- based system that encompasses
safety and

quality. In 1996, the Canadian Food Inspection Agency and industry formed a
task force to further study and improve the system. The resulting Quality
Management Program (QMP) requires that all seafood companies develop,
maintain, and implement comprehensive quality and safety plans. Seafood
companies are required to register with the inspection agency, and each
processor's QMP plan must include the following:

? Management roles and responsibilities, which may include a written
description of each manager's accountability or a written statement of
commitment signed by all management staff.

? Product and process information that includes product descriptions and
processing steps.

? A prerequisite plan that addresses facilities design; construction;
maintenance; and all potential sources of contamination, including employee
hygiene; and company recall procedures.

? A regulatory action point plan that describes controls designed to ensure
that the products meet fish inspection regulations addressing tainted,
decomposed or unwholesome products, packaging materials and ingredients, and
labeling requirements. ? A HACCP plan identifying and addressing any health
and safety hazards

related to the product or process by applying the seven HACCP principles. ?
Steps for verifying and maintaining the QMP plan.

The inspection agency reviews the QMP plans, including HACCP plans, before
they are put into effect by seafood firms. A written hazard analysis is part
of the required documentation. Once the plan is implemented, the inspection
agency conducts in- depth audits of the QMP's implementation. For imported
seafood products, Canada adopted a two- tier regulatory system. Importers
that have a regular license can import seafood products from any country but
must notify the inspection agency within 48 hours of the product's entry.
Depending on the product's history, the inspection

agency decides whether to detain the product for visual examination and/ or
testing. Inspection agency officials stated that, on average, they test
about 15 percent of all imported seafood in this category. Alternatively,
importers may voluntarily participate in the QMP for Importers. The program
allows seafood importers to develop their own system for

monitoring and evaluating products that they import while the inspection
agency conducts quarterly audits of participating companies to ensure
compliance with seafood safety standards. Importers must perform or have
performed product testing at a minimum frequency of 15 percent or as
otherwise established in Canadian agreements with other countries. The

inspection agency has also provided an incentive for importers to obtain
products from foreign companies that have a good history of compliance.
Under this arrangement, foreign seafood firms with a good compliance record
are considered for reduced inspection frequencies at an importer's

request. If approved, they are incorporated in the “A” list. To
be part of this list, a foreign seafood firm must, at a minimum, have 10
acceptable inspections from at least 30 imported lots of seafood. Firms on
the “A” list are subjected to unannounced inspections at
predetermined frequencies.

Chile's Seafood Safety In 1994, Chile implemented a HACCP- based inspection
program for Program seafood to improve the effectiveness of its seafood
exporters' certification

program and to respond to future requirements of Chile's major export
markets- the European Union (Directive 91/ 493/ CEE) and the United States.
The Chilean National Seafood Service (Servicio Nacional de Pesca,
Sernapesca) administers Chile's seafood safety program. Chilean officials
said that the HACCP system in Chile is modeled after the U. S. National
Marine Fisheries Service System and Canadian systems. Therefore, it
incorporates sanitation, safety, and quality features. Seafood exporters,
including factory vessels, must be registered and authorized to export
through the certification program. It is illegal to operate without
registering with Sernapesca. In order to receive an export certification,
exporters must implement the HACCP requirements.

Sernapesca issued procedures manuals, technical norms, and inspection
instructions. Together, these documents instruct industry and inspectors on
how to review and validate HACCP plans, how to collect official

samples, and how to conduct objective inspections. Sernapesca must review
and approve HACCP plans. Seafood exporters are required to maintain a
written hazard analysis plan and to have it available for inspection.
Officials think it is important to know the reasoning for inclusion or
exclusion (in the HACCP plans) of hazards reasonably likely to occur.
Sernapesca conducts monthly sanitation inspections of seafood exporters. If
the exporter fails the sanitation inspection, it is removed from
Sernapesca's approved exporter list and thus can no longer receive export
certification. Vessels are inspected when they come into port- every 3

months on average. Seafood firms are instructed to conduct biweekly
verifications of their HACCP systems, and Sernapesca inspects firms once
every 2 to 3 months, depending on the product. After inspection, firms are
classified I through IV, depending on the number of deficiencies observed by
inspectors. These categories determine whether firms will continue to be
certified.

Comments From the Food and Drug

Appendi x I V

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

See comment 1. See comment 2.

See comment 2. See comment 3.

See comment 4.

See comment 5. See comment 2.

See comment 5.

The following are GAO's comments on the Food and Drug Administration's
letter dated January 17, 2001. GAO's Comments 1. We modified our report to
include the actual number of cases associated

with seafood and with meat and poultry outbreaks. We also added CDC's
observation that reported illness outbreaks tend to be for illnesses more
likely to be recognized. According to CDC, diagnosable illnesses, such as
scombroid poisoning from seafood, are more easily recognized than illnesses
from nonspecific gastrointestinal symptoms caused by other foods.

2. We believe that until FDA develops an inventory that identifies and
assesses each vessel's on- board activities, FDA's view that vessels not
performing functions beyond preparing the catch for holding pose little or
no risks lacks credibility. Numerous fishing vessels handle high- risk
products, such as tuna, which if not properly handled or held- kept at the
appropriate temperature- may result in foodborne illness. Furthermore,
although the number of vessels processing seafood on- board is unknown,
federal and state officials' estimates lead us to conclude that a
significant number could be conducting on- board processing similar to that
conducted by land- based seafood firms. Land- based seafood firms that head,
eviscerate, and freeze products are required to comply with the HACCP
regulations. Exempting vessels from the HACCP regulations also eliminates
the requirement for a written standard operating procedure for

sanitation aimed at ensuring basic sanitation procedures and practices. We
modified the report to clarify the HACCP regulatory requirements for
vessels.

With respect to FDA's comments on domestic firms found not to need HACCP
plans, we did not mean to suggest that all 1, 055 of FDA's determinations
exempting products from needing HACCP plans were

incorrect. We do question, however, whether FDA inspectors were justified in
exempting as many as 516 of these products on the grounds that storage and
repacking firms do not handle products presenting significant hazards. In
our view, many of these firms handle products with significant hazards and
should have HACCP plans. We did modify the report to include FDA's

view that frozen products do not present significant food safety risks. 3.
We agree that since the publication of our 1998 report, FDA has initiated
actions to improve controls over imported foods aimed at preventing
unscrupulous importers from bypassing or subverting port- of- entry

activities. However, the fact remains that without equivalence agreements,
FDA has to rely on labor- intensive inspections of products at the port of
entry as its primary line of defense against the entry of unsafe foods. We
continue to believe that port- of- entry inspections alone do not
effectively ensure the safety of imported seafood. Using port- of- entry
inspections to augment a program certifying that imported products are
produced under

equivalent food safety systems is a much more efficient and effective way to
ensure the safety of imported foods. Providing FDA with authority similar to
that provided for the Food Safety and Inspection Service would allow FDA to
leverage its resources and provide greater assurance that imported seafood
is safe. Accordingly, we did not modify the report.

4. We agree with FDA's comment that its efforts to gather and analyze
seafood firms' compliance with HACCP requirements have merit but continue to
believe that compliance information alone is not a good indicator of the
seafood program's impact on reducing contamination that could cause
foodborne illness. A performance- based measurement, such as that used by
USDA, would improve FDA's evaluation of the effectiveness of its programs
for ensuring seafood safety. While there may not be any single widespread
hazard in seafood, scombrotoxin and ciguatoxin caused 46 and

42 percent of seafood illness outbreaks, respectively. Therefore, we
continue to believe that FDA should identify the hazards of most concern (e.
g., scombrotoxin), develop baseline information on such hazard( s), and use
that information to assess the effectiveness of its programs in reducing the
prevalence of such hazards. We modified the report to provide

additional information regarding FDA's compliance- based data. 5. We
continue to believe that an emphasis on equivalence agreements by
establishing goals and time frames is appropriate because equivalency is
generally a more effective way to ensure the safety of imported food.
Equivalence agreements will help FDA reduce its reliance on importer and
port- of- entry inspections and enable it to leverage its staff resources by
sharing the responsibility for seafood safety with the exporting countries.
Goals and time frames are standard management tools used to monitor the

progress of important initiatives, such as equivalence agreements. Without
them, there is less incentive to complete the initiatives. In this regard,
FDA and the Canadian Food Inspection Agency have had discussions and engaged
in activities aimed at determining the equivalence of the two countries'
systems since Canada first requested such action in 1997. Furthermore,
without any equivalence agreements for seafood, importers must use the more
difficult and costly alternative of providing documentary support that the
exporting seafood processor has a HACCP system that

meets U. S. requirements. We also recommend that Congress consider mandating
that FDA certify other countries' equivalence before their seafood products
are allowed entry into the United States. If Congress decides to act in this
regard, we would envision that Congress would

provide FDA a number of years to complete such determinations. By
establishing goals and time frames for equivalence agreements, FDA would
assist Congress in this effort. FDA could establish alternative provisions
for countries that export seafood to the United States and have systems that
are not equivalent, such as requiring them to provide laboratory tests or
other assurances that the seafood meets U. S. standards.

See comment 2. See comment 5. 6. We commend FDA for taking action to add
foreign firms to its import alert list after we brought this issue to its
attention. We modified the report to include this information.

Appendi x V

GAO Contacts and Staff Acknowledgments 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. (150170) Lett er

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GAO United States General Accounting Office

Page 1 GAO- 01- 204 Federal Oversight of Seafood

Contents

Contents Page 2 GAO- 01- 204 Federal Oversight of Seafood

Page 3 GAO- 01- 204 Federal Oversight of Seafood United States General
Accounting Office

Washington, D. C. 20548 Page 3 GAO- 01- 204 Federal Oversight of Seafood

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Appendix I

Appendix I Scope and Methodology

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Appendix I Scope and Methodology

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Appendix I Scope and Methodology

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Appendix II

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Appendix III

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

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

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Appendix IV

Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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See comment 6.

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Appendix IV Comments From the Food and Drug Administration

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Appendix IV Comments From the Food and Drug Administration

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Appendix V

Appendix V GAO Contacts and Staff Acknowledgments

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United States General Accounting Office Washington, D. C. 20548- 0001

Official Business Penalty for Private Use $300

Address Correction Requested Presorted Standard

Postage & Fees Paid GAO Permit No. GI00
*** End of document. ***