Food Safety: FDA's Imported Seafood Safety Program Shows Some	 
Progress, but Further Improvements Are Needed (30-JAN-04,	 
GAO-04-246).							 
                                                                 
More than 80 percent of the seafood that Americans consume is	 
imported. The Food and Drug Administration (FDA) is responsible  
for ensuring that imported seafood is safe and produced under	 
sanitation and safety systems comparable to those of the United  
States. Since GAO reported in 2001 that FDA's seafood inspection 
program did not sufficiently protect consumers, additional	 
concerns have arisen about imported seafood containing banned	 
substances, such as certain antibiotics. In this review, GAO was 
asked to evaluate (1) FDA's progress in implementing the	 
recommendations in the 2001 report and (2) other options to	 
enhance FDA's oversight.					 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-04-246 					        
    ACCNO:   A09187						        
  TITLE:     Food Safety: FDA's Imported Seafood Safety Program Shows 
Some Progress, but Further Improvements Are Needed		 
     DATE:   01/30/2004 
  SUBJECT:   Consumer protection				 
	     Contaminated foods 				 
	     Food inspection					 
	     Health hazards					 
	     Importing						 
	     Performance measures				 
	     FDA Hazard Analysis and Critical Control		 
	     Point System					 
                                                                 

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GAO-04-246

United States General Accounting Office

GAO

                       Report to Congressional Requesters

January 2004

FOOD SAFETY

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

                                       a

GAO-04-246

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

More than 80 percent of the seafood that Americans consume is imported.
The Food and Drug Administration (FDA) is responsible for ensuring that
imported seafood is safe and produced under sanitation and safety systems
comparable to those of the United States. Since GAO reported in 2001 that
FDA's seafood inspection program did not sufficiently protect consumers,
additional concerns have arisen about imported seafood containing banned
substances, such as certain antibiotics. In this review, GAO was asked to
evaluate (1) FDA's progress in implementing the recommendations in the
2001 report and (2) other options to enhance FDA's oversight.

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

January 2004

FOOD SAFETY

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

Since GAO's January 2001 report, FDA's imported seafood safety program has
shown some improvement. FDA inspects more foreign firms, and its
inspections show that more U.S. seafood importers are complying with its
requirements. FDA also slightly increased the number of seafood products
it tests at U.S. ports of entry to just over 1 percent. However, FDA still
has not established equivalence agreements with seafood exporting
countries as GAO recommended in its 2001 report. Equivalence agreements
that commit U.S. trading partners to maintain comparable food safety
systems are an efficient way to ensure imported seafood safety. Unlike the
U.S. Department of Agriculture, FDA is not legally required to certify
that countries exporting food products to the United States have
equivalent food safety systems. According to a panel of nationally
recognized experts that GAO convened to address this and other issues,
establishing these types of agreements would shift some of FDA's burden
for ensuring seafood safety to foreign governments. This shift, in turn,
would allow FDA to focus its limited resources on seafood products from
countries with less advanced food safety systems.

FDA also made little progress regarding the recommendation GAO made in
2001 that FDA communicate to U.S. port-of-entry personnel serious
deficiencies identified during inspections so that potentially
contaminated imported seafood is examined before it enters the United
States. GAO found that FDA continues to experience long delays between
finding deficiencies and taking action. For example, GAO's review of
foreign firm inspection records found that it took an average of 348 days
for FDA to alert port-ofentry personnel about serious safety problems
identified at six foreign firms. Moreover, GAO found that FDA does not
prioritize enforcement actions when violations that pose the most serious
public health risk occur or have an automated system to track the time
involved in documenting, reviewing, and processing enforcement actions.

FDA officials acknowledged some of the problems that GAO identified
regarding FDA's current imported seafood inspection program, but they also
raised concerns about limited inspection resources and competing
priorities, such as the recent need to implement provisions of the
Bioterrorism Act of 2002. GAO identified several options that FDA could
consider to augment its resources and enhance its current program,
including (1) commissioning seafood inspectors from the National Oceanic
and Atmospheric Administration's (NOAA) Seafood Inspection Program, (2)
using state regulatory laboratories and/or private laboratories to augment
FDA's testing of imported seafood, and (3) developing a program to use
third-party inspectors to augment its program.

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

To view the full product, including the scope and methodology, click on
the link above. For more information, contact Lawrence J. Dyckman at (202)
512-3841 or [email protected].

Contents

  Letter

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

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

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

1 4 7

13

24 29 29 30

Appendixes

Appendix I:

Appendix II:

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

Scope and Methodology

Summary of Expert Panel Observations on the Safety of Imported Seafood

Members of Our Expert Panel Summary of Panel Observations

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

Comments from the Food and Drug Administration

GAO Comments

Comments from the National Oceanic and Atmospheric Administration

GAO Contacts and Staff Acknowledgments

GAO Contacts
Staff Acknowledgments

33

37 37 37

42

43 52

54

55 55 55

Figures	Figure 1: Figure 2:

Figure 3:

Figure 4: Figure 5:

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

Contents

Abbreviations

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

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

A

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

January 30, 2004

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

The Honorable Trent Lott
United States Senate

The Honorable John Breaux
United States Senate

More than 80 percent of the seafood that Americans consume is imported
from an estimated 13,000 foreign suppliers in about 160 nations.1 If
contaminated, imported and domestic seafood can cause foodborne
illnesses, with problems ranging from mild gastrointestinal discomfort to
neurological damage. The Centers for Disease Control and Prevention
(CDC) estimates that contaminated seafood (finfish and crustaceans)
accounted for about 15 percent of the documented foodborne illness
outbreaks in the United States-a greater percentage than either meat or
poultry, even though meat and poultry are consumed at 8 and 6 times the
rate of seafood, respectively.2

The Food and Drug Administration (FDA) is responsible for ensuring the
safety of domestic and imported seafood. It implements the Hazard
Analysis and Critical Control Point (HACCP) system-a science-based,
food safety program introduced for seafood in 1997. The HACCP system is
designed to improve food safety by having industry identify and control
biological, chemical, and physical hazards in products before they enter
the
market. Under FDA's food safety regulations, seafood-processing firms
must identify hazards that are reasonably likely to occur and must develop
and implement plans to control those hazards.

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

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

To ensure compliance with its food safety regulations, FDA requires that
importers meet one of two conditions. First, importers may obtain seafood
from countries that have entered into voluntary agreements with FDA. These
agreements may document that foreign countries' seafood safety systems are
equivalent to or in compliance with that of the United States. Second, if
these agreements do not exist, importers must have records demonstrating
that foreign firms' products offered for entry into the United States have
been processed in accordance with U.S. HACCP requirements. Such records
may include, for example, a copy of the foreign firms' HACCP plan. FDA
inspects some U.S. importers and some foreign firms to determine their
compliance with HACCP regulations. It also examines and tests selected
samples of imported seafood products at U.S. ports of entry to verify
their safety. FDA has the authority to hold imported seafood products
while it determines if the product is adulterated.3 FDA also has the
authority to detain imported seafood products and require importers to
demonstrate that the products are not adulterated, a process called
detention without physical examination (DWPE).

The Department of Commerce also has a role in promoting seafood safety and
quality. The department has statutory authority for providing voluntary
inspection services to assist in marketing seafood products. These
inspection services are provided through its Seafood Inspection Program,
which is located in the National Oceanic and Atmospheric Administration
(NOAA).4 The Seafood Inspection Program provides fee-for-service safety,
sanitation, and/or product inspections for approximately 2,500 foreign and
domestic firms annually. Program services include inspections for safety,
wholesomeness, and proper handling as well as grading seafood, laboratory
analysis, training, and product inspection and certification. The Seafood
Inspection Program's services affect 17 percent of the imported and
domestic seafood consumed in the United States.

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

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

In 2001, we reported that FDA's oversight of domestic and imported seafood
provided insufficient assurance that the seafood is safe.5 With regard to
imported seafood, we found that FDA relied on reviews of importers'
records, inspections of selected foreign firms, and product examination
and testing at the port of entry to ensure seafood safety-but that FDA
reviewed records or performed inspections for a very small percentage of
products. For example, FDA tested less than 1 percent of all seafood
products imported into the United States in fiscal year 1999. To better
ensure the safety of imported seafood, we recommended that FDA develop
specific goals and time frames for establishing agreements with other
countries to document that their seafood safety systems are equivalent to
that of the United States. Without such equivalence agreements, FDA must
rely principally on its reviews of importers' records to ascertain that
imported seafood products are processed under an acceptable food safety
system. Many importers did not have the required documentation, and, when
they did, the documentation often did not adequately demonstrate
compliance. We also recommended that FDA communicate to agency personnel
at U.S. ports of entry deficiencies identified during its importer and
foreign firm inspections because FDA was not scrutinizing products from
problem firms at these ports.

Since our 2001 report, questions have persisted about the effectiveness of
FDA's seafood safety program and about the adequacy of the agency's
inspection and laboratory resources. You asked us to (1) reevaluate FDA's
program for ensuring the safety of imported seafood and determine the
status of FDA's efforts to implement our recommendations and (2) explore
other options for enhancing FDA's imported seafood inspection program,
such as using the inspection programs and laboratories of other entities.

In response to your request, we reexamined FDA's program for ensuring the
safety of imported seafood, including the status of equivalence
agreements, inspections of importers and foreign firms, and product
examination and testing at ports of entry. To determine FDA's progress in
establishing equivalence agreements with countries that export seafood to
the United States, we interviewed FDA officials who are responsible for
evaluating other countries' food safety systems. To evaluate FDA's actions
to enforce compliance with its food safety requirements, we analyzed FDA's
records of inspections for a random sample of U.S. importers and for

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

all of the foreign firm inspections conducted in fiscal year 2002. To
explore other options for enhancing FDA's current imported seafood
inspection program, we convened a panel of nationally recognized food
safety experts. The panel, selected with assistance from the National
Academies, discussed the effectiveness of FDA's current approach for
ensuring the safety of imported seafood and provided advice on ways to
strengthen it. In addition, the panel (1) discussed several other options,
such as using NOAA's Seafood Inspection Program and laboratories, as well
as those of other entities, to enhance FDA's program and (2) deliberated
the advantages and disadvantages of the various options. Appendix I
contains additional details of our scope and methodology, and appendix II
contains a summer of the expert panel's observations on the safety of
imported seafood.

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

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

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

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

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

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

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

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

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

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

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

Background	CDC estimates that contaminated food causes 76 million
illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States
each year. On the basis of the number of confirmed outbreaks of foodborne
disease in 1997, the latest year for which CDC's data are available,
seafood is one of the leading causes of foodborne illness outbreaks in the
United States.6 Seafood products represented about 15 percent, or 26, of
the 169 foodborne illness outbreaks from a confirmed source-a level
greater than that associated with meat or poultry products, which are
consumed at 8 and 6 times the rate of seafood, respectively. However, as
we reported in 2001, CDC officials said that foodborne illness outbreaks
are generally underreported and that it is easier to identify the source
of some diagnosable illnesses, such as scombroid poisoning from seafood,
than illnesses that result from nonspecific gastrointestinal symptoms
caused by other foods. Moreover, the actual number of individual cases of
illnesses resulting from traced outbreaks were higher for meat and poultry
(619 and 353 cases, respectively) compared with 108 cases for seafood. FDA
stated that seafood outbreaks may have involved fewer individual cases of
illness because seafood has much lower consumption rates than meat and
poultry. FDA also noted that some seafood-related illnesses may be caused
by recreational or subsistence fishing over which the federal government
has little or no control. The Center for Science in the Public Interest, a
consumer interest group that works on nutrition and food safety issues,
has used CDC data and other sources to track the number of reported
foodpoisoning outbreaks in the United States and estimates that seafood
was responsible for 18 percent of the outbreaks of foodborne illnesses
that the center tracked between 1990 and 2002.7

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

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

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

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

o 	Chemical hazards-include compounds such as methylmercury, which can
cause illness from long-term exposure; residues from drugs unapproved for
use in food animals, such as chloramphenicol and nitrofurans, or overuse
of approved drugs that are sometimes used in aquaculture production, which
may be carcinogenic, allergenic, and/or cause antibiotic resistance in
humans; and marine toxins. According to FDA officials, two marine toxins
with potentially serious health effects-scombrotoxin and ciguatoxin-cause
most of the reported seafood-related illnesses, 8 including
gastrointestinal and neurological problems. These toxins are heat
resistant and cannot be inactivated by cooking.

o 	Physical hazards-include foreign objects in food that can cause harm
when eaten, such as glass or metal fragments.

Figure 1 shows the steady growth in U.S. consumption and imports of
seafood between 1993 and 2002. According to data from the NOAA's National
Marine Fisheries Service, the United States imported about 4.2 billion
pounds, or more than 80 percent, of its seafood in 2002, as shown in the
figure.9

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

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

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

Billions of pounds

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

Total consumption Imports

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

In addition, U.S. seafood consumption rose about 25 percent between 1980
and 2002, from 12.5 pounds per person to 15.6 pounds per person.10 Most
seafood consumed in the United States is imported from an estimated 160
countries and 13,000 foreign processors. In 2002, the top 6 seafood
exporting countries-Canada, China, Thailand, Chile, Ecuador, and
Vietnam-accounted for approximately 63 percent of imported seafood.
Imported products include fresh and frozen tuna and salmon as well as
crustaceans, such as shrimp and lobsters. Figure 2 shows the proportion of
imports to the United States from the 6 leading exporting countries.

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

following recommendations by the National Academy of Sciences and others,
FDA adopted a program of preventative controls that are designed to
identify hazards during the seafood-production process and minimize the
risk of contamination. The HACCP regulations made seafoodprocessing firms
responsible for identifying harmful microbiological, chemical, and
physical hazards that are reasonably likely to occur and for establishing
critical control points (CCP) to prevent and reduce contamination. The
HACCP system is based on the following seven principles that each seafood
firm must address:

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

o 	Identify the CCP. Identify a point, step, or procedure in the
production process where controls can be applied to prevent, eliminate, or
reduce to an acceptable level a food safety hazard that is reasonably
likely to occur.

o 	Establish critical limits for each CCP. Set the maximum or minimum
value at which parameters, such as cooking time and temperature, must be
controlled at each CCP to prevent, eliminate, or reduce the hazard to an
acceptable level.

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

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

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

o 	Establish record-keeping and documentation procedures. Maintain
documentation, including the HACCP plan; CCP monitoring; corrective
actions; and verification activities.

Under the HACCP regulations, seafood-processing firms are responsible for
conducting a hazard analysis and for developing and implementing HACCP
plans for hazards that are determined to be reasonably likely to occur.
These hazards may include marine toxins, microbiological contamination,
chemical contamination, pesticides, drug residues,

decomposition in certain species, parasites, the unapproved use of food or
color additives, and physical hazards. For each hazard identified, the
firms must establish CCPs to prevent or reduce contamination. Firms also
must establish and monitor sanitation procedures to ensure, among other
things, the (1) general cleanliness of food contact surfaces, including
utensils, gloves, and outer garments, and (2) control of employee health
conditions.

As we reported in 2001, FDA has four approaches to verify compliance with
HACCP regulations and ensure the safety of imported seafood. FDA has the
authority to enter into voluntary agreements with individual countries on
the basis of a determination of equivalence of their seafood safety
systems with U.S. HACCP requirements. First, under the provisions of the
World Trade Organization Agreement on the Application of Sanitary and
Phytosanitary Measures, to which the United States is a signatory, FDA is
obligated to enter into consultations with the aim of achieving
equivalence agreements upon the request of other World Trade Organization
member nations.11 FDA considers other systems to be equivalent when it
finds one or more of an exporting country's food safety measures-such as
laws, regulations, guidance, and procedures-to be equivalent to our own.
U.S. importers can demonstrate HACCP compliance by acquiring seafood from
countries with these agreements. Second, in the absence of such
agreements, importers are responsible for demonstrating, through
documentation, that the seafood they import into the United States is
produced under systems that are compliant with U.S. HACCP requirements.
During its periodic inspections, FDA reviews this documentation to
determine whether importers have met their responsibilities under the
HACCP regulations. Third, FDA also inspects a limited number of foreign
seafood firms to determine the firms' compliance with HACCP. Lastly, FDA
selects a small number of individual shipments at U.S. ports of entry to
conduct visual examinations and/or collect and test samples to determine
if the seafood is misbranded or adulterated. FDA commented that detaining
suspect imported seafood for physical or laboratory examination by the
importer is also part of its import control strategy.

If FDA observes HACCP violations during its inspections and testing, it
can take several regulatory actions. For example, FDA issues warning
letters in cases where violations raise safety concerns that may lead to
enforcement

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

action, such as detention, seizure, or injunction-which is a court order
to refrain from distributing a product. In the case of foreign firms, a
warning letter could advise them of a forthcoming detention, the only
enforcement action that is available. Firms that receive warning letters
are asked to respond to FDA in writing to indicate what actions they will
take to correct the identified problems.

To fund FDA's food safety programs, Congress provided $393 million for
fiscal year 2002. This amount represents a $106 million increase over
FDA's budget for fiscal year 2001, including a $93 million supplemental
appropriation for counterterrorism activities, including those in the
Bioterrorism Act of 2002.12 FDA used some of this increase to enhance its
coverage of imported foods, including hiring over 600 new food safety
investigators and laboratory personnel; increasing the number of
port-ofentry examinations and laboratory testing; and conducting foreign
inspections that focused on high-risk foods, including seafood.

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

Since our January 2001 report, FDA has made improvements to three of the
four approaches it uses for ensuring the safety of imported seafood-
importer inspections, foreign inspections, and port-of-entry inspections.
FDA has not implemented either of the recommendations we made in our 2001
report regarding establishing equivalence agreements with exporting
countries or communicating deficiencies found during inspections to FDA's
port-of-entry personnel. Additionally, FDA continues to experience long
delays in issuing warning letters or detaining imported seafood at U.S.
ports of entry after investigators find serious deficiencies. By not
taking timely regulatory action, FDA increases the likelihood that unsafe
seafood will enter the U.S. market.

FDA's Program Shows Some Improvement Since Our Last Report

We found that FDA has made some progress in strengthening the efficacy of
three approaches for ensuring the safety of imported seafood. However, the
agency has made no progress regarding the development of equivalence
agreements with seafood exporting countries. Figure 3 summarizes the
changes that have taken place in FDA's seafood safety program.

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

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

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

Program approaches Status

Source: GAO analysis of FDA's seafood safety program.

As we reported in 2001, in the absence of equivalence agreements, U.S.
seafood importers are required to maintain written product specifications
and take at least one of six affirmative steps to document foreign firms'
compliance with U.S. requirements. Figure 4 shows the regulatory

requirements for importers and the documentation that importers can use to
demonstrate compliance.

Figure 4: Importers' Regulatory and Compliance Requirements

Importers purchase seafood from countries that have equivalence agreements
with FDA

Importers cannot use this option because there are no equivalence
agreements

Regulations

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

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

and

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

a. HACCP and sanitation records from processor

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

c. regular inspection of foreign processor

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

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

f. other appropriate verification measures

                            Source: FDA regulations.

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

While importers have made some progress in maintaining the required
documentation, they are still far from full compliance, according to our
analysis of FDA's inspection forms for fiscal year 2002. Specifically, on
the basis of our random sample of inspections, we estimate that importers
had the required documentation for 48 percent of the products they
imported, which is up from the 27 percent noted in our 2001 review.13 That
is, an estimated 48 percent of imported seafood products listed in the FDA
inspection forms contained (1) a written product specification document
and (2) documentation for at least one of the six possible affirmative
steps required by the regulations. In fiscal year 2002, FDA inspected
fewer domestic importers-402 (of an estimated 8,500) compared with 644
that the agency reports it inspected in fiscal year 1999.14 Our analysis
shows that FDA investigators made some errors when documenting these 2002
inspections. On the basis of our survey, we estimated that in about 4
percent of the inspection forms, FDA investigators erroneously indicated
that the exporting country had an equivalence agreement in place for
seafood. Therefore, they did not require the importer to produce the
additional documentation required in the absence of an equivalence
agreement (written product specifications and at least one affirmative
step).15 FDA officials said the oversight occurred because the
investigators had correctly determined that the importers received
products from firms on a list of preferred providers developed by the
Canadian Food Inspection Agency (CFIA), but the investigators erred in
assuming that having the preferred provider list meant that Canada has an
equivalence agreement with the United States. FDA officials said they will
take steps to clarify the requirement with field personnel to avoid
confusion in the future.

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

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

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

FDA also increased the number of foreign countries visited and seafood
firms inspected since we last reported in 2001. FDA visited 13 of an
estimated 160 countries in fiscal year 2002 to provide education on the
U.S. HACCP requirements and to inspect 108 of about 13,000 seafood firms
compared with 4 countries and 37 firms inspected in fiscal year 1999. FDA
selects the countries for inspection on the basis of previous compliance
problems, the volume of seafood exported to the United States, and the
type of product and associated risk. Once it selects a country, FDA
selects foreign firms that have a problematic compliance history and works
with the country's inspection authority to identify other firms for
inspection. According to the Director, FDA's Office of Seafood, FDA plans
to inspect about 100 seafood firms in 10 or more foreign countries
annually in the future. Although this number represents fewer firms and
countries than FDA inspected in 2002, it represents more than FDA
inspected in fiscal year 1999. These inspections tend to be targeted on
developing countries that are major exporters to the United States.

FDA officials also said they have begun to increase laboratory testing of
imported seafood, in particular for aquaculture drug residues, as a result
of the increase in staff resources the agency received from the
Bioterrorism Act of 2002. According to these officials, in fiscal year
2002, FDA had 310 full-time-equivalent positions for inspections and
laboratory testing of all food, with 70 allocated for imported seafood; by
fiscal year 2004, FDA estimates that it will have 681 positions, with at
least 103 allocated for imported seafood. Furthermore, the proportion of
foreign seafood products detained for laboratory testing increased
slightly, from less than 1.0 percent in fiscal year 1999 to about 1.2
percent in fiscal year 2002, while imported seafood products increased by
13 percent (from 3.7 to 4.4 billion pounds) over the same period.16 FDA
officials expect laboratory testing to increase to about 1.4 percent of
imported seafood products in fiscal year 2004, after the newly hired
investigators and laboratory personnel are fully trained.

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

FDA Still Lacks Equivalence or Other Agreements with Seafood Exporting
Countries

Although FDA stated in January 2001 that it planned to make progress
toward accomplishing foreign equivalence assessments and had listed this
goal as one of its priorities, the agency has not made progress in this
regard. As a result, FDA still has no equivalence or other agreements with
any seafood exporting country. At the time of our 2001 report, FDA had not
established any equivalence agreements with countries that export seafood
to the United States. However, the agency was discussing equivalence
agreements with Australia, Canada, and New Zealand and a compliance
agreement with Japan.17 To expedite development of these agreements, we
recommended that FDA develop specific goals and time frames for completing
them. FDA did not agree with this recommendation, but it stated that
accomplishing foreign equivalence assessments would be one of its
priorities for fiscal year 2001.

FDA officials now state that developing these agreements is no longer a
priority because of several factors. First, they point out that
equivalence agreements, as such, do not necessarily contribute to the
enhanced safety of imported seafood. Foreign producers are already
required to produce seafood products under a HACCP-based system that
provides for a high level of assurance of safety, and therefore, an FDA
finding of equivalence of a foreign seafood regulatory program or
individual seafood safety measures would be unlikely to substantially
improve the safety of imported seafood. Second, FDA officials said that
the United States does not require a finding of equivalence as a condition
for exporting seafood to the United States. Third, the procedures and
criteria that are necessary to conduct equivalence assessments have only
recently been agreed upon at the international level by the Codex
Alimentarius Commission.18 FDA is working with other U.S. agencies in
considering how best to incorporate these international guidelines in
situations where equivalence assessments might be helpful for either
public health protection or trade facilitation. The Office of the U.S.
Trade Representative (USTR), the cabinet agency responsible for developing
and coordinating U.S. international trade policy, generally agreed with
this view and also said that even with equivalence agreements, FDA would
still be required to conduct compliance reviews

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

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

and audits in these countries.19 Finally, both FDA and USTR said the time
and resources required to develop equivalence agreements for seafood may
outweigh the benefits.

We agree that establishing equivalence agreements would not automatically
result in improved seafood safety. However, by establishing agreements
with countries that are able to demonstrate that their safety systems are
comparable to ours, FDA could free inspection resources and allow more
extensive examination of seafood products from countries with less
advanced systems.20 Because FDA does not have equivalence agreements with
countries that are exporters of seafood to the United States, FDA
principally relies on a review of documentation at importers' offices to
attempt to determine whether importers have met their responsibilities and
requirements under the seafood HACCP regulations. As we previously
discussed in this report, FDA reported inspecting only about 8 percent of
domestic importers in fiscal year 2003.

Our panel of experts also concluded that equivalence agreements or less
comprehensive alternatives represent an effective approach for ensuring
the safety of imported seafood and would also shift some of the burden for
ensuring that imported seafood meets U.S. HACCP requirements to exporting
countries. Furthermore, the panel suggested that FDA concentrate its
efforts on first developing agreements with countries known to have
high-quality food safety systems, thereby allowing FDA to focus its
limited inspection resources on countries known to have lesser quality
food safety systems.

We also acknowledge that time and resources are a necessary factor in
negotiating such agreements. However, we note that FDA has entered into
similar agreements with several countries that export fresh and frozen
shellfish products (fresh and frozen oysters, clams, mussels, and whole or
roe-on scallops) to the United States. By reaching agreements through
individual memorandums of understanding with Canada, Chile, Mexico, New
Zealand, and South Korea, FDA acknowledged that the foreign countries'
shellfish sanitation programs meet U.S. standards. If it chose to

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

20Under the meat and poultry inspection acts, the Secretary of the
Department of Agriculture must certify that exporters of meat and poultry
products have equivalent food safety systems before their products can be
exported to the United States.

do so, FDA could enter into these types of agreements with countries that
export seafood products to the United States as well.

We also note that CFIA has established 14 agreements with foreign
exporting countries, including agreements for seafood products. According
to CFIA officials, these agreements allow CFIA to decrease the rate of
inspection for products from participating countries and direct its
resources to higher risk products from countries without such agreements.
In addition, CFIA believes that such agreements provide a vehicle for
increased communication, thereby allowing the exporting nation to take
corrective actions at violating firms discovered during CFIA's
verification inspections.

Most FDA Regulatory Actions Are Not Timely

To ensure that FDA takes prompt regulatory action when its investigators
find food safety violations during importer and foreign firm visits, we
recommended in our 2001 report that FDA communicate deficiencies to
port-of-entry personnel so that they can examine potentially contaminated
imported seafood before it can enter the United States. Although FDA
agreed with this recommendation, we found that it continues to experience
long delays between finding deficiencies and taking action, such as
issuing a warning letter or detaining a product. As a result, potentially
contaminated seafood could be entering the U.S. market.

Once FDA investigators complete an inspection of U.S. importer's
documentation or of a foreign firm's processing plant, they submit a
recommendation and/or report to headquarters, which decides on regulatory
action.21 As explained below, FDA issues either untitled letters or
warning letters to inform responsible officials of violations found during
the inspection and to afford the officials the opportunity to voluntarily
take appropriate and prompt corrective action prior to the initiation of
enforcement action. The use of these letters is based on the expectation
that a majority of inspected firms will voluntarily comply.

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

FDA issues untitled letters when the documented violations do not meet the
criteria for detention.22 Untitled letters may address, for example, the
foreign company's failure to have its HACCP plan list sulfites, an
allergen; failure to monitor the safety of water; or failure to maintain
the cleanliness of food contact surfaces. These letters do not set time
frames for taking corrective action and do not require a response from the
firm.

FDA also issues warning letters when it finds violations that can directly
affect product safety, such as no controls for scrombrotoxin, which is a
toxin most commonly found in tuna, mahi-mahi, and bluefish that can cause
severe allergic reactions and diarrhea. These letters could lead to
enforcement action, such as product detention, if the company does not
promptly and adequately correct the problem. To ensure prompt and adequate
correction, FDA requires that warning letters be issued within 30 work
days-approximately 45 calendar days.

However, FDA is not required to issue letters to firms prior to taking
enforcement action. The agency has the authority to take immediate
enforcement action, such as detaining a firm's products.23 Under section
801(a) of the Federal Food, Drug, and Cosmetic Act, FDA can refuse
admission of imported products on the basis of information that the
product "appears" to be in violation of food safety requirements. When the
violations remain uncorrected despite prior warnings, FDA headquarters
notifies field offices by listing the firm and product on an Import Alert,
ordinarily the next course of action. According to FDA officials, now that
the requirements of seafood HACCP are well established, the agency intends
to use its refusal authority as the lead action without prior warning to
prevent the products of problem foreign processors from entering the
country. Our analysis of foreign firm inspections shows that the agency
used this authority for one firm in fiscal year 2002.

According to our review of inspection records for 99 of 108 foreign firms
that the agency visited in fiscal year 2002, FDA is encountering
significant

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

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

delays in issuing warning letters when serious violations are
identified.24 During its inspections, FDA found that of these 99 foreign
firms, 40 had serious violations that warranted regulatory action. For 20
of these 40 firms, FDA decided to issue a warning letter. However, FDA
took an average of 157 calendar days to issue these warning letters. As
shown in figure 5, all 20 warning letters exceeded FDA's time frame
requirement of approximately 45 calendar days.

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

                        Number of warning letters issued

                                       8

45a

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

226

Days from inspection to issuance

Source: GAO analysis of FDA data.

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

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

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

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

salted, and fermented fish that are susceptible to the growth of bacteria,
including Clostridium botulinum. This bacteria produces a toxin that can
cause gastroentiritis, vertigo, and respiratory failure. For the other 20
firms that did not receive warning letters, FDA issued untitled letters to
14 firms and is considering what action to take for the remaining 6
firms.26 Appendix III provides a more detailed analysis of FDA's foreign
firm inspections in fiscal year 2002.

In addition to failing to issue warning letters in a timely manner, FDA
encountered significant delays in alerting port-of-entry personnel to
detain imported seafood shipments from firms identified with serious
safety problems. On average, the agency took 348 calendar days to alert
port-ofentry personnel about such products coming from 6 of the 99 foreign
firms that the agency inspected in fiscal year 2002. Moreover, 4 of the 6
firms involved were processing high-risk products, which should have
caused FDA to take more prompt enforcement action. By not taking timely
enforcement actions and communicating these actions to U.S. port-of-entry
personnel, FDA increases the likelihood that unsafe products will enter
the U.S. market.

Similar delays occurred when FDA investigators found problems with U.S.
importers' records. For the 96 inspection forms we reviewed, FDA found
that 16 importers had serious violations, such as failure to have the
required documentation. The agency issued warning letters to 8 of these
importers. The average time elapsed between the date of the inspection and
issuance of the warning letter was 103 calendar days; only 2 letters were
issued within the required 45 calendar days. Furthermore, 5 of the warning
letters covered high-risk products, including scombrotoxinsusceptible
seafood, which, if not properly handled, could cause serious health
problems requiring hospitalization, particularly for elderly individuals.

FDA officials acknowledged that these delays are excessive and
unacceptable and attributed them to a change in personnel responsible for
reviewing and issuing these letters. In addition, these officials stated
that the time frames were exceeded because the agency has been compelled
to give precedence to other public health concerns, such as developing
programs to protect the food supply against terrorist threats. Finally, we

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

found that FDA does not prioritize enforcement actions when violations
that pose the most serious public health risk occur or have an automated
system for tracking the time involved in documenting, reviewing, and
processing enforcement actions. As a result of increased funding, FDA
recently increased the number of personnel responsible for reviewing and
issuing these letters and expects to substantially increase its
timeliness. Additionally, FDA is in the early stages of developing an
automated system that will track the time involved in documenting,
reviewing, and processing enforcement actions.

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

Several options could help FDA overcome some of the problems we identified
with its current regulatory approach for ensuring the safety of imported
seafood. These options could also help to augment FDA's inspections of
foreign seafood firms, port-of-entry product examinations, and testing of
imported seafood. However, each option presents certain challenges that
FDA would need to address. First, NOAA could provide staff from its
Seafood Inspection Program to augment FDA's inspections capabilities, and
FDA is considering the advantages and disadvantages of doing so. However,
some FDA officials are concerned about the cost of using NOAA and about a
perceived conflict of interest because NOAA's inspections are
fee-for-service. Second, FDA could contract with state regulatory
laboratories to augment its current capacity to analyze imported seafood
samples, but our expert panel and FDA officials said that most state
laboratories might not have excess capacity to assist FDA. Third, FDA
could use private laboratories to assist in screening seafood samples,
provided that FDA first attests to the laboratories' capabilities to
perform the work. Finally, if it has the authority, FDA could use
third-party inspectors to conduct HACCP inspections of foreign processing
firms and domestic importers; however, FDA would need to certify the
inspectors' competency. FDA has not undertaken a comprehensive review of
its legal authorities in this area.

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

Could Augment FDA's services include

Regulatory Program  o  foreign firm inspections,

o  HACCP training,

o  domestic importer inspections,

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

o 	assistance in developing and verifying equivalence or other types of
agreements with seafood exporting countries.

NOAA officials also said that they could conduct some domestic seafood
inspection services that FDA currently conducts, which would allow FDA to
refocus some of its resources on imported seafood. For example, NOAA
inspectors could certify domestic seafood products shipped to the European
Union and other countries, which is a service that NOAA provided in the
past on a fee-for-service basis. Also, FDA and NOAA could agree to
recognize NOAA's current inspections of approximately 240 domestic
processing firms and authorize NOAA to inspect other domestic firms for
compliance with HACCP. NOAA officials estimate that they could provide FDA
with up to 22 full-time-equivalent field inspectors as well as additional
technical support staff in its headquarters office.

In addition, NOAA and FDA officials are now negotiating the terms of an
agreement to use two NOAA laboratories to screen imported shrimp samples
for the antibiotic chloramphenicol. FDA is taking this action to increase
its testing capacity in response to the detection of the drug in imported
shrimp by food safety authorities in Europe, Canada, and some U.S. states.
Chloramphenicol is banned for use in food-producing animals because there
is no known safe level for human ingestion of this substance. If the
negotiations succeed, FDA would increase its screening capacity by 400
samples per year.27

FDA recognizes that it has the authority to use NOAA and is considering
the advantages and disadvantages of doing so. While one official raised
concerns about a public perception of potential conflicts of interest
because NOAA inspections are fee-for-service, others said that this
potential problem could be addressed in an agreement between the two
agencies. Additionally, NOAA officials said that this concern could be
alleviated, in whole or in part, through its receipt of direct
appropriations to conduct these activities and/or through contracts with
FDA that use

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

appropriated funds. Also, FDA-sponsored inspector training and periodic
audits of NOAA activities could further address such perceptions. FDA
officials also pointed out that it would have to incur costs to provide
training to NOAA inspectors and would have to develop an agreement with
NOAA specifying how NOAA would conduct inspections and investigations on
FDA's behalf. We agree that FDA would need to incur additional costs to
use NOAA inspectors and laboratories, but these costs may be less than
those FDA would incur if the agency were to hire and train investigators
and laboratory analysts without prior seafood experience.

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

FDA is testing only a small fraction of the seafood entering the United
States, about 1.2 percent in fiscal year 2002. Our panelists and past GAO
reports have stated that port-of-entry laboratory testing is an
ineffective "overall" approach for ensuring the safety of imported
seafood. Nevertheless, our panelists believed that increased testing is
desirable as one approach for verifying the presence of biological,
chemical, or drug residues. Therefore, they stated that using state
regulatory laboratories to augment FDA's seafood testing, such as state
Departments of Health or Agriculture, would be beneficial because

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

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

o 	FDA's use of state laboratories could improve coordination and
information exchange regarding seafood-testing results between state
laboratories and FDA.

However, the panelists noted a disadvantage to using state regulatory
laboratories. Many states are financially constrained and therefore may
not have the excess capacity, equipment, time, or qualified analysts to
assist FDA. Furthermore, if FDA were to consider using state laboratories
to assist with port-of-entry testing, it would have to ensure that all
laboratories are using appropriate sampling and testing methodology.

While FDA laboratory officials agreed that using state regulatory
laboratories could be beneficial, they expressed some concerns regarding
using the laboratories to support FDA regulatory action. FDA officials
agreed that state regulatory laboratories are likely to have established

chain-of-custody procedures-that is, state laboratories control the sample
from the time they receive it through the sample analysis so that the
sample is not inappropriately altered. Additionally, FDA officials said
state laboratories would be required to meet all FDA analysis and data
requirements. However, using these laboratories may be a costly
alternative because FDA would have to provide training and oversight in
addition to the cost required to conduct the analyses. Furthermore, FDA
officials noted that states may not have excess capacity to assist FDA.

Despite these concerns, FDA is considering a pilot program with Florida to
determine how it could use state laboratory results. This pilot program is
similar to FDA's proposed agreement with NOAA for testing imported shrimp
for the drug chloramphenicol. Under the proposed pilot program with
Florida, FDA would collect the samples and the state laboratory would
screen them for traces of chloramphenicol residues. The state laboratory
would also perform the more sophisticated confirmation testing on the
positive screens, which FDA could then use to take regulatory action.
According to FDA officials, the agency must first determine the level of
seafood sampling to perform given its other competing public health
priorities. They said that considerable funding would be required to
establish a meaningful laboratory assistance program with outside sources.

Private Laboratories Could Assist FDA If They Were Accredited

Currently, FDA does not accredit or use any private laboratories to
collect or analyze seafood samples. However, for some seafood violations,
it does allow seafood firms to use private laboratories to provide
evidence that imported seafood previously detained because of safety
concerns is now safe and can be removed from the detention list at the
port of entry. To assist FDA in analyzing more imported seafood, our panel
recommended that FDA accredit private laboratories that comply with FDA's
testing methodologies. This option would also provide FDA with greater
assurance about the quality of the laboratories importers use to
demonstrate that their detained products are safe and can be released into
commerce.

FDA officials said that using private laboratories to conduct screenings
could result in increased analytical capacity, but this option would
require more agency oversight, thereby making it a costly alternative. We
note, however, that FDA currently accepts the results from private
laboratories that importers provide to the agency to demonstrate that
products detained at ports of entry are safe and can be released into
commerce. FDA also noted that these private laboratories generally follow
the appropriate methodology for sampling, documentation, chain-of-custody,
and analysis.

The agency performs a detailed review of the laboratories' sampling and
testing methodology for each individual submission to FDA, but this review
is not an overall quality assurance review of the entire laboratory and
should not be taken as a general endorsement of the submitting laboratory.

As with state laboratories, if FDA were to use private laboratory results
to take regulatory action, it would be required to provide training and
oversight in addition to funding. However, FDA officials stated that in
their view, these laboratories are generally not equipped to perform
confirmation testing due to the expense and expertise required.
Furthermore, since private laboratories would continue to provide
laboratory analysis to the industry that FDA regulates, the agency would
have additional responsibilities to eliminate conflict of interest and
protect any regulatory testing from bias.

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

In the absence of equivalence agreements, FDA could consider developing a
program that uses certified third-party firms to conduct HACCP inspections
on its behalf, both at foreign processing firms and domestic importers.
The Department of Health and Human Services has begun to take this
approach by accrediting third-parties to inspect manufacturers of medical
devices, as authorized by Congress.28 However, no similar specific
legislation exists permitting third-party inspection of seafood firms, and
FDA has not undertaken a comprehensive review of its authorities to
accredit private third-parties to inspect seafood firms.

Our expert panel believes that industry should pay for the use of these
third-parties to shift some of the burden from FDA to support the costs
associated with such a service. Following this approach, FDA could inspect
more foreign firms and importers without incurring substantial additional
costs. However, FDA is concerned that a fee-for-service arrangement for
these services would create a public perception of a conflict of interest.
According to our panel, to combat this potential problem, FDA would have
to implement a system of oversight to ensure that the third-parties are
adequately performing their duties. Finally, domestic importers could use

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

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

Conclusions	Since FDA first issued the HACCP regulations for seafood
safety in 1997, U.S. seafood importers and foreign firms have made some
progress in implementing and demonstrating compliance with FDA's seafood
safety requirements. However, FDA is still verifying compliance at only a
small number of seafood importers and foreign firms. Similarly, FDA's
port-ofentry product examination and testing is, and will continue to be,
limited. In addition, FDA is no longer making it a priority to negotiate
equivalence agreements with seafood-exporting countries, which remains one
of the most effective methods for ensuring the safety of imports. Indeed,
our panel of seafood safety experts believes that these agreements would
help FDA reduce its reliance on importer and port-of-entry inspections and
would enable the agency to leverage its staff resources by sharing the
responsibility for seafood safety with exporting countries, especially
those that are known to produce safe seafood. Coupled with the lack of
timely compliance and enforcement action, FDA's efforts to ensure the
safety of imported seafood continue to provide insufficient protection to
consumers. Unless other options for strengthening these efforts are
explored, the risk of unsafe products released into the U.S. market will
continue.

Recommendations for Executive Action

To more efficiently and effectively monitor the safety of imported
seafood, we recommend that the Secretary of Health and Human Services
direct the Commissioner of FDA to work toward developing a memorandum of
understanding with NOAA that leverages NOAA's Seafood Inspection Program's
resources. The memorandum of understanding should address mutually
agreeable protocols and training programs that are necessary to begin
using NOAA employees to provide various services. Those services could
include inspections of foreign firms, importer inspections, port-ofentry
examinations and sample collections, and laboratory analyses.

To strengthen FDA's current imported seafood program and ensure the safety
of seafood consumed in the United States, the Commissioner of FDA should
take the following five actions:

o 	make it a priority to establish equivalence or other similar types of
agreements with seafood-exporting countries, starting first with countries
that have high-quality food safety systems;

o 	develop and implement a system to track the time involved in
documenting, reviewing, and processing regulatory and enforcement actions,
such as issuing warning letters and detaining unsafe products, so that FDA
can identify the reasons for the delays and take actions to address them;

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

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

o 	explore the potential of implementing a certification program for
thirdparty inspectors, which would involve reviewing FDA's legal
authorities and considering the costs and benefits, including developing
and implementing the standards, controls, and oversight necessary to
provide FDA with reasonable assurance that third-party inspectors are
qualified and independent.

Agency Comments and Our Evaluation

We provided FDA and NOAA with a draft of this report for review and
comment. We received written comments from the Commissioner, FDA, which
are presented in appendix IV. FDA also provided technical corrections,
which we have incorporated into the report as appropriate. We received a
letter from the Chief Administrative Officer, NOAA, stating that the
agency did not have any comments. The letter is presented in appendix V.

Regarding the six specific recommendations we made in this report, FDA
generally concurred with five and disagreed with one. FDA generally
concurred that it should (1) work toward developing a memorandum of
understanding with NOAA that leverages NOAA's Seafood Inspection Program's
resources; (2) develop and implement a system to track the time involved
in documenting, reviewing, and processing regulatory and enforcement
actions so that FDA can identify the reasons for the delays and take
actions to address them; (3) give priority to taking enforcement actions
when violations that pose the most serious public health risk occur; (4)
consider the costs and benefits of implementing an accreditation program
for private laboratories; and (5) explore the potential of implementing a
certification program for third-party inspectors. Since we will be
reviewing FDA's implementation of third-party inspections under the
Medical Device User Fee and Modernization Act of 2002, FDA could use

the results of this review in assessing the potential to use third-party
inspectors for imported seafood.

FDA did not concur with our recommendation to make it a priority to
establish equivalence or other similar types of agreements with
seafoodexporting countries, starting first with countries that have
high-quality food safety systems. In commenting on this recommendation,
FDA said the agency is not currently positioned to assign high priority to
negotiating equivalence or other types of agreements with numerous
countries that export seafood to the United States in light of the
pressing priorities associated with implementation of the Bioterrorism
Act. FDA also said that establishing these agreements is extraordinarily
resource intensive. We agree that the process for creating these
agreements is complex and resource intensive; however, we continue to
believe that it should be a priority for FDA to negotiate equivalence or
other less comprehensive agreements with seafood exporting countries to
leverage its limited inspection resources. Additionally, FDA should view
the creation of these agreements as a long-term investment in improving
imported seafood safety. In the absence of equivalence or other agreements
such as memorandums of understanding with seafood-exporting countries, FDA
must continue to rely principally on reviews of importer records to
determine whether imported seafood is produced under acceptable food
safety systems.

FDA also raised some concerns about inferences that could be drawn from
the report. For example, FDA said that our draft report implied that
seafood has a higher likelihood of causing foodborne illness than other
foods on the basis of a comparison of the number of foodborne illness
outbreaks in the United States from seafood-related causes than from meat
and poultry. FDA also said that our draft report did not acknowledge that
foodborne illness outbreaks associated with seafood also include those
from recreational and subsistence fishing, over which the federal
government has little or no control. We modified this report to include
the actual number of cases associated with seafood and meat and poultry
outbreaks. We also added CDC's observation that foodborne illness
outbreaks are generally underreported and that it is easier to identify
the source of some diagnosable illnesses, such as scombroid poisoning from
seafood, than illnesses that result from nonspecific gastrointestinal
symptoms caused by other foods. Additionally, we added FDA's comment that
some seafood-related illnesses may be caused by recreational or
subsistence fishing, over which the federal government has little or no
control.

As agreed with your offices, unless you publicly announce the contents of
this report earlier, we plan no further distribution of it until 30 days
from the date of this letter. We will then send copies to interested
congressional committees; the Secretary of Health and Human Services; the
NOAA Administrator; the United States Trade Representative; the Director,
Office of Management and Budget; and other interested parties. We will
make copies available to others on request. In addition, the report will
be available at no charge on GAO's Web site at http://www.gao.gov.

If you or your staff have any questions about this report, please call me
at (202) 512-3841. Key contributors to this report are listed in appendix
VI.

Lawrence J. Dyckman Director, Natural Resources

and Environment

Appendix I

Scope and Methodology

To reevaluate the Food and Drug Administration's (FDA) program for
ensuring the safety of imported seafood and determine the status of
efforts to implement our previous recommendations, we interviewed
cognizant government and industry officials. Specifically, we interviewed
officials and/or reviewed documents from the following FDA units: Center
for Food Safety and Applied Nutrition's Office of Seafood, Office of
Compliance, and Office of Constituent Operations; Office of Regulatory
Affair's Office of Enforcement, Office of Regional Operations, and Office
of Resource Management; Office of Chief Counsel; and Office of
International Programs. We also visited the FDA district office in
Bothell, Washington, where large volumes of seafood are processed, and we
met with FDA officials to discuss relevant regulations, policies, and
procedures. We also visited two U.S. importers to observe FDA's importer
inspection process firsthand and to discuss their views.

To assess the progress that FDA has made since our 2001 report,1 we
analyzed the agency's inspection records of U.S. importers. Specifically,
we randomly selected a probability sample of 117 inspections from a list
of 415 importer inspections that nominally represented all importer
inspections conducted by FDA for fiscal year 2002. From this sample, 13
inspections were outside the scope of this assignment-for example, they
were for molluscan shellfish or the seafood actually was a domestic
product. In addition, for 8 additional in-scope inspections, FDA could not
locate complete documentation (6 inspections); and FDA did not complete a
standardized inspection form (Form 3502) at the time of the inspection (2
inspections).

For the 96 in-scope inspections for which documentation was found, we
analyzed the Form 3502 that investigators completed for each imported
seafood product2 during fiscal year 2002. The 96 inspections were
associated with a total of 112 Forms 3502. 3

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

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

3We removed 5 inspections forms that were incorrectly completed.

Appendix I
Scope and Methodology

Because we followed a probability procedure based on a random selection of
inspections (and thereby products), our sample is only one of a large
number of samples we might have drawn. Since each sample could have
provided different estimates, we express the confidence in the precision
of our particular sample's results as 95 percent confidence intervals
(e.g., +- 7 percentage points). These are intervals that would contain the
actual population values for 95 percent of the samples we could have
drawn. As a result, we are 95 percent confident that each of the
confidence intervals in this report will include the true values in the
study population.

The estimate that 48 percent of U.S. importers' products had the required
documentation is surrounded by a 95 percent confidence interval that
ranges from 36 percent to 60 percent. We estimated that 4 percent of the
FDA inspection forms erroneously indicate that the United States has an
equivalence agreement with the exporting country. This estimate is
surrounded by a 95 percent confidence interval that ranges from 1 percent
to 10 percent.

To assess FDA's progress with regard to inspections of foreign firms, we
obtained 107 of 108 foreign inspection reports for fiscal year 2002 for
the 13 countries that FDA visited-Brazil, China, Costa Rica, Honduras,
Iceland, Jamaica, Mexico, Poland, Taiwan, Thailand, Trinidad and Tobago,
Uruguay, and Vietnam. Of these 107 inspection reports, we removed 8
because they covered shellfish, which was outside the scope of our review.
We compared FDA's findings for the remaining 99 inspections with FDA's
actions at U.S. ports of entry.

For the sample of importer inspections and the entire set of the foreign
firm inspections, FDA provided inspection results in hard copy because FDA
investigators do not transmit information electronically. FDA also
provided us with summary data from the system used to maintain inspection
results for our analyses of foreign firm and importer inspections. We
conducted a data reliability assessment of the importer and foreign firm
inspection information, which indicated that the data and data systems
used by FDA were sufficiently reliable and complete to perform our
analyses.

To assess the time frames for issuing warning letters and other pertinent
information, we analyzed the 20 warning letters FDA issued following its
foreign firm inspections and the 8 warning letters FDA issued following
its U.S. importer inspections conducted during fiscal year 2002 that FDA
determined warranted enforcement action. Recognizing FDA's time frame of
30 work days for FDA to process a warning letter, we did not consider

Appendix I
Scope and Methodology

any warning letter issued within 45 calendar days after the date of
inspection as having exceeded FDA's issuance time frame.

In addition, we interviewed and/or received documents from the National
Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries
Service, Seafood Inspection Program, and National Sea Grant Program. To
obtain industry's views on the Hazard Analysis and Critical Control Point
(HACCP) system for seafood and FDA's oversight of seafood firms, we also
met with the National Fisheries Institute-a seafood trade association
whose membership includes domestic and international firms. We also met
with the Center for Science in the Public Interest-a consumer organization
focusing on nutrition and food safety-which investigates and reports on
outbreaks of foodborne illnesses. Finally, we spoke with officials from
the Canadian Food Inspection Agency to discuss their regulations for
ensuring the safety of imported seafood and to gain insight on agreements
that Canada established with other foreign countries' food inspection
authorities. We also received information from the Department of
Agriculture about its program for requiring equivalence determinations
before allowing exported meat and poultry products to enter the United
States. However, the scope of this review did not include exploring
whether Agriculture could make inspection or other resources available to
augment FDA's seafood inspection program.

To explore other options for enhancing FDA's existing imported seafood
safety program, we assembled a panel of recognized experts on the
following seafood-related areas: seafood policy, laws, and regulations
(including HACCP); public health, epidemiology, and microbiology; risk
management and assessment; and international trade policy. With advice
from the National Academies, we selected 63 seafood safety experts as
potential panelists. From these 63 contacts, we chose the final nine
panelists on the basis of the following criteria: (1) recommendations we
received from the National Academies and participation on previous academy
panels; (2) recommendations from others knowledgeable in the field of
seafood safety; (3) the individual's area of expertise and experience; (4)
the type of organization represented, including academic institutions,
seafood industry, trade groups, and consumer groups; and (5) geographic
representation. (The names and affiliations of the panel members are
listed in app. II.) On July 2, 2003, we held an all-day meeting with the
nine panelists at our office in Washington, D.C. Before the meeting, we
provided each panel member with a set of four general discussion
questions. At the end of each discussion, we asked the panelists to
respond, using an anonymous ballot, to a set of questions that were based
on the general

Appendix I
Scope and Methodology

discussion topics. We recorded and transcribed the meeting to ensure that
we accurately captured the panel members' statements.

We conducted our review from February 2003 through November 2003 in
accordance with generally accepted government auditing standards.

Appendix II

Summary of Expert Panel Observations on the Safety of Imported Seafood

This appendix provides the names and affiliation of our expert panel
members and summarizes the discussions held at the all-day meeting. The
information presented in this appendix may not represent the views of
every member of the panel. Also, this information should not be considered
to be the views of GAO.

Members of Our Expert Panel

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

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

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

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

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

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

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

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

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

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

Summary of Panel 	On July 2, 2003, we held an all-day meeting with the
nine panelists at our office in Washington, D.C. Before the meeting, we
provided each panel

Observations	member with a set of four general discussion questions. At
the end of each discussion, we asked the panelists to respond, using an
anonymous ballot,

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

to a set of questions that were based on the general discussion topics. We
recorded and transcribed the meeting to ensure that we accurately captured
the panel members' statements. The panelists discussed two overarching
themes: (1) changes that FDA has made to improve its ability to ensure
imported seafood safety and (2) options for improving FDA's current
regulatory approach.

FDA's Recent Changes	Since our last report on this matter in 2001, FDA has
made changes to its approach for ensuring the safety of imported seafood.
Panelists specifically discussed these changes, including (1) a shift in
focus from inspecting foreign countries' entire food safety systems for
equivalence to inspecting more foreign firms for HACCP compliance, (2) a
slight increase in the number of port-of-entry examinations and laboratory
testing of imported seafood, and (3) an increase in testing for
aquaculture drug residues. Specifically:

o 	Panelists suggested that inspecting a small number of foreign firms for
HACCP compliance, rather than inspecting foreign countries' entire food
safety systems for equivalence, is ineffective because FDA only inspects
about 100 seafood firms in 10 countries annually, out of a universe of an
estimated 13,000 firms in about 160 countries.

o 	Panelists believed that increasing the number of port-of-entry
examinations and laboratory testing for imported seafood, while desirable,
would be ineffective because this approach is not consistent with the
preventative HACCP approach.

o 	Because regulatory authorities around the world are increasingly
finding aquaculture drug residues, the panelists believed that more
testing for drug residues would be a valuable verification step in an
effective HACCP system. Furthermore, panelists believed that FDA should
shift its focus to the source of production to prevent the abuse of legal
substances or the use of banned aquaculture drugs.

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

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

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

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

Equivalence Agreements  o 	Panelists recommended that FDA establish
equivalence agreements in order to more efficiently utilize its limited
resources. They believed that equivalence agreements would be more
effective than FDA's direct inspection of foreign firms for ensuring HACCP
compliance and would also allow the agency to focus resources on the
countries, firms, and products that pose the greatest risk, thereby
shifting the burden for HACCP compliance from FDA to foreign governments
and foreign firms. Panelists stated that such agreements should not imply
that FDA must find a foreign government's seafood safety system "equal" to
that of the U.S. system. For example, panelists said that FDA should have
flexibility in terms of what it considers equivalent and should also
consider alternatives to country-to-country agreements (e.g.,
product-to-country, company-to-country, and hazard-specific agreements).

o 	The panel recommended that FDA first consider one-way equivalence
agreements, with counties where the United States imports large quantities
of seafood but does not export significant quantities. Although panelists
noted that two-way agreements are preferred, they believed that using
one-way equivalence agreements initially would better ensure that foreign
firms are meeting U.S. standards. However, U.S. seafood exporters may
object to one-way agreements, arguing that these would favor the foreign
countries, which may have barriers to U.S. exports.

o 	Panelists recommended that FDA establish a timeline for agreements,
although there was no consensus on the best way to develop this timeline.
Possible suggestions included a phased-in process, based on the quantity
of exports to the United States, and the establishment of agreements based
on the willingness of participants.

o 	Panelists believed that Congress should mandate that FDA establish
equivalence agreements; however, FDA should be allowed to determine how
the agreements are structured and implemented. The panel also expressed
concern that our trading partners could view mandating equivalence as
protectionist. Additionally, panelists said FDA should

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

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

o 	The panel believed that FDA should provide additional training and
education to foreign governments and foreign firms on HACCP requirements,
and that industry should pay for this training.

Importer Inspections  o 	Panelists recommended that FDA identify competent
inspection authorities to establish lists of preferred suppliers, in which
the foreign government inspects firms wishing to export to the United
States, to assure the agency that these firms meet HACCP requirements. By
adopting this approach, FDA could then target inspection and testing
resources to nonpreferred suppliers.

o 	Panelists recommended that FDA develop an accreditation program for
private laboratories that demonstrate compliance with FDA's testing
methodologies. FDA could then establish a list of approved, accredited
domestic laboratories to augment their port-of-entry testing for
compliance and enforcement. Additionally, domestic importers could use the
accredited foreign and domestic laboratories to demonstrate, through
testing, that their seafood products were processed in accordance with
HACCP requirements. Panelists believed that most domestic private
laboratories are capable of meeting FDA's standards, such as sample
chain-of-custody, laboratory procedure, and qualified analysts, and could
provide timely results.

Foreign Firm Inspections  o 	Panelists recommended that FDA establish a
standardized program to certify private, third-party inspectors to conduct
HACCP inspections of foreign processing firms and domestic importers. The
third-party inspectors would be paid for by industry and monitored by FDA,
thereby allowing for more foreign firm and importer inspections at little
additional cost to FDA.

o 	Panelists recommended that FDA place more responsibility on foreign
governments to ensure that foreign firms are aware of, and are meeting,
their responsibilities under HACCP. Under an effective HACCP system, the
panelists felt that FDA's emphasis should be on inspection and testing in
the foreign country where the seafood is harvested and processed and where
hazards are introduced.

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

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

the exporting countries how to prevent these problems from reoccurring.

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

Testing

operated by the state Department of Health or Agriculture) may be a good
option for assisting FDA in testing imported seafood products,
particularly in those states with ports and seafood industries. State
laboratories provide comparable testing for state regulatory authorities
and have procedures in place that could meet FDA's standards for
compliance testing. State laboratories are also well equipped for food
testing and provide reliable results. Panelists did note, however, that
most states are financially constrained, and therefore state laboratories
may not have any excess capacity (e.g., qualified analysts, equipment
time, or laboratory space) to analyze additional samples for FDA.
Furthermore, in order to use the facilities, FDA would need to harmonize
testing methodologies.

o 	Panelists suggested that FDA use the National Marine Fisheries Service
laboratories in Pascagoula, Mississippi, and Seattle, Washington, to
augment testing at ports of entry. Panel members believed that this was a
good option for FDA because these laboratories currently conduct seafood
research and testing.

o 	Panelists did not recommend that FDA use academic laboratories for
testing at ports of entry. They stated that most academic laboratories are
not structured to do compliance testing and would not meet FDA's standards
for chain of custody of the samples or acceptable documentation for
compliance or enforcement actions.

Appendix III

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

Number of Firms inspections

                                   All firms

With a HACCP plan as requireda

Not required to have a HACCP plan

Processing high-risk seafood

Processing high-risk seafood with HACCP plansa

Found to have serious violations by FDAa

Placed on detention

                       Firms processing high-risk seafood

With adequate HACCP plans

With inadequate HACCP plansa

                  Firms found to have serious HACCP violations

Issued a warning letter

Issued an untitled letterb

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

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

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

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

Appendix IV

Comments from the Food and Drug Administration

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

Appendix IV
Comments from the Food and Drug
Administration

                                 See comment 1.

                                 See comment 2.

                                 See comment 3.

Appendix IV
Comments from the Food and Drug
Administration

                                 See comment 4.

Appendix IV
Comments from the Food and Drug
Administration

Appendix IV
Comments from the Food and Drug
Administration

                                 See comment 5.

Appendix IV
Comments from the Food and Drug
Administration

Appendix IV
Comments from the Food and Drug
Administration

                                 See comment 6.

Appendix IV
Comments from the Food and Drug
Administration

Appendix IV
Comments from the Food and Drug
Administration

                                  Appendix IV
                        Comments from the Food and Drug
                                 Administration

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

GAO Comments 1.	We modified our report to state that although FDA does not
have an automated system for computing the time it takes to review warning
letter and untitled letter recommendations, it is in the early stages of
developing such a system. This system will enable FDA to track the time
involved in documenting, reviewing, and processing enforcement actions.

2.	We modified this report to include the actual number of cases
associated with seafood and meat and poultry outbreaks. We also added the
Centers for Disease Control and Prevention's observation that foodborne
illness outbreaks are generally underreported and that it is easier to
identify the source of some diagnosable illnesses, such as scombroid
poisoning from seafood, than illnesses that result from nonspecific
gastrointestinal symptoms caused by other foods. Additionally, we added
FDA's comment that some seafood-related illnesses may be caused by
recreational or subsistence fishing, over which the federal government has
little or no control.

3.	As shown in our report, FDA inspects only a small percentage of U.S.
importers, examines and samples a very small amount of imported seafood at
U.S. ports of entry, and inspects few seafood firms in foreign countries
each year. In the absence of equivalence or other agreements such as
memorandums of understanding with seafood-exporting countries, FDA must
continue to rely principally on reviews of importer records to determine
whether imported seafood is produced under acceptable food safety systems.
For these reasons, we continue to believe that FDA should develop such
agreements as quickly as possible. Moreover, FDA acknowledged in its final
HACCP rule, issued in December 1995, that in the absence of significant
numbers of agency inspections of foreign processing facilities, a
memorandum of understanding can be the most efficient and effective
mechanism for ensuring that foreign processing plants are operating in
compliance with the requirements of the regulations.1

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

Appendix IV
Comments from the Food and Drug
Administration

4. We modified this report to include FDA's basis for issuing these
letters.

5.	We acknowledge that establishing equivalence or other agreements is
complex and resource intensive. However, we continue to believe, as
supported by our panel of nationally recognized food safety experts, that
equivalence agreements or less comprehensive alternatives, such as
compliance agreements or memorandums of understanding represent a more
effective long-term approach for ensuring the safety of imported seafood
and would allow FDA to leverage its staff resources by shifting some of
its regulatory burden to exporting countries. Also, U.S. importers would
be able to rely on the foreign regulatory authority to ensure compliance
with HACCP requirements by foreign processors.

Also see comment 3.

6.	Our report recognizes that FDA is beginning to take action to develop
an automated system to track the time involved in documenting, reviewing,
and processing regulatory actions.

Also see comment 1.

Appendix V

Comments from the National Oceanic and Atmospheric Administration

Appendix VI

                     GAO Contacts and Staff Acknowledgments

GAO Contacts	Lawrence J. Dyckman, (202) 512-3841 Maria Cristina Gobin,
(202) 512-6526

Staff Acknowledgments

(360298)

In addition to the individuals named above, John C. Smith, Kenya Jones,
and Lisa Vojta made key contributions. Other contributors included, Aldo
Benejam, Oliver Easterwood, Lynn Musser, Cynthia Norris, Paul Pansini,
Katherine Raheb, Carol Herrnstadt Shulman, Sidney Schwartz, and Kathy
Summers.

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