Food Safety
FDA's Imported Seafood Safety Program Shows Some Progress, but Further Improvements Are Needed
Gao ID: GAO-04-246 January 30, 2004
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.
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.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
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GAO-04-246, Food Safety: FDA's Imported Seafood Safety Program Shows Some Progress, but Further Improvements Are Needed
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Report to Congressional Requesters:
January 2004:
FOOD SAFETY:
FDA's Imported Seafood Safety Program Shows Some Progress, but Further
Improvements Are Needed:
[Hyperlink, http: //www.gao.gov/cgi-bin/getrpt?GAO-04-246]:
GAO Highlights:
Highlights of GAO-04-246, a report to congressional requesters
Why GAO Did This Study:
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.
What GAO Found:
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-of-entry 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.
What GAO Recommends:
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.
www.gao.gov/cgi-bin/getrpt?GAO-04-246.
To view the full product, including the scope and methodology, click
on the link above. For more information, contact Lawrence J. Dyckman
at (202) 512-3841 or dyckmanl@gao.gov.
[End of section]
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:
Appendixes:
Appendix I: Scope and Methodology:
Appendix II: Summary of Expert Panel Observations on the Safety of
Imported Seafood:
Members of Our Expert Panel:
Summary of Panel Observations:
Appendix III: Results of GAO Analysis of FDA's Inspections of 99
Foreign Firms, Fiscal Year 2002:
Appendix IV: Comments from the Food and Drug Administration:
GAO Comments:
Appendix V: Comments from the National Oceanic and Atmospheric
Administration:
Appendix VI: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Staff Acknowledgments:
Figures:
Figure 1: U.S. Seafood Consumption and Imports, 1993 to 2002:
Figure 2: Percentage of Seafood Imports to the United States from Major
Exporting Countries, 2002:
Figure 3: Status of FDA's Program Approaches for Ensuring the Safety of
Imported Seafood, Fiscal Years 1999 and 2002:
Figure 4: Importers' Regulatory and Compliance Requirements:
Figure 5: Number of Days from Inspection to Issuance of Warning Letters
for Serious Violations Found at 20 Foreign Firms, Fiscal Year 2002:
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:
Letter 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.[Footnote 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.[Footnote 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.
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.[Footnote 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).[Footnote 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.
In 2001, we reported that FDA's oversight of domestic and imported
seafood provided insufficient assurance that the seafood is
safe.[Footnote 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 all of the foreign firm inspections
conducted in fiscal year 2002. To explore other options for enhancing
FDA's current imported seafood inspection program, we convened a panel
of nationally recognized food safety experts. The panel, selected with
assistance from the National Academies, discussed the effectiveness of
FDA's current approach for ensuring the safety of imported seafood and
provided advice on ways to strengthen it. In addition, the panel (1)
discussed several other options, such as using NOAA's Seafood
Inspection Program and laboratories, as well as those of other
entities, to enhance FDA's program and (2) deliberated the advantages
and disadvantages of the various options. Appendix I contains
additional details of our scope and methodology, and appendix II
contains a summer of the expert panel's observations on the safety of
imported seafood.
Results in Brief:
FDA has made some improvements to its imported seafood safety program
since our January 2001 report, but it has not acted on key
recommendations we made at that time. In terms of improvements, FDA
investigators have found that more importers have the required
documentation to demonstrate compliance with U.S. food safety
requirements, and FDA now inspects more foreign firms in countries that
supply seafood to the United States. FDA also increased laboratory
testing of seafood products at ports of entry from less than 1.0
percent in fiscal year 1999 to about 1.2 percent in fiscal year 2002.
However, the agency has not addressed our recommendations to improve
imported seafood safety. Specifically, FDA has not, as we recommended
done the following:
* Developed goals and time frames for establishing equivalence
agreements with seafood exporting countries. Consequently, FDA
continues to rely, in part, on reviewing importers' records to
ascertain whether imported products are processed under an acceptable
food safety system. Although FDA did not agree with our recommendation,
it said that it would continue to assess the equivalency of foreign
countries' seafood safety systems and enter into agreements as
appropriate. It also said that this effort would be a priority. FDA
officials now report that the costs of developing such agreements may
outweigh the food safety benefits and, therefore, these assessments are
no longer an FDA priority. Furthermore, FDA officials' attention and
resources are now more focused on biosecurity issues. Our food safety
panel considered these arguments and concluded that FDA should pursue
equivalence agreements or other less comprehensive agreements, such as
product-specific agreements, in order to shift some of the burden for
HACCP compliance to foreign governments, manufacturers, and processors.
The panelists suggested that FDA focus first on establishing agreements
with countries that have high-quality food safety systems--an approach
that would conserve FDA resources to inspect products from countries
with less advanced food safety systems.
* Communicate to port-of-entry personnel the serious deficiencies
identified during importer and foreign country inspections, so that
potentially contaminated imported seafood is examined before entry into
the United States. FDA continues to experience long delays in this
regard. For example, in 2002, FDA took an average of 348 days to alert
port-of-entry personnel about serious safety problems identified with
seafood products from six foreign firms. Even when FDA investigators
had recommended immediate detention of imported seafood shipments,
based on foreign firm inspections, the agency did not take this action
because its policy is to first forward all recommendations to
headquarters for review. When we brought these delays to headquarters
officials' attention, they stated that the agency does not have an
automated system for documenting the time involved in reviewing these
recommendations but that such delays are unacceptable. This lack of
management oversight fails to give priority to taking enforcement
action for serious violations, and it increases the likelihood that
unsafe products will enter the U.S. market.
Regarding our second objective--to explore other options for enhancing
FDA's imported seafood inspection program--we identified four
alternatives that can help augment FDA's inspection resources at ports
of entry and in foreign countries and also increase the agency's
laboratory capacity to test imported seafood products. Given FDA
officials' concerns about limited inspection resources and competing
priorities, the following options may provide useful alternatives, but
they also present some challenges.
* Use NOAA's Seafood Inspection Program personnel to augment FDA's
inspection capabilities. According to NOAA officials, they could
provide FDA with an estimated 22 full-time-equivalent inspectors to,
among other things, assist with inspections of U.S. importers and
foreign firms and with examinations and sampling of imported seafood at
ports of entry. FDA acknowledges that it has the legal authority to
commission NOAA employees to conduct inspections and investigations on
FDA's behalf by entering into a memorandum of understanding. However,
some FDA officials are concerned that this option has the potential for
a conflict of interest because NOAA inspections are based on fee-for-
service. FDA also believes that NOAA inspectors would need additional
training.
* Use state regulatory laboratories to augment FDA's capacity for
analyzing imported seafood. FDA is already considering using at least
one state regulatory laboratory. According to our expert panel, this
option has merit since these laboratories have capabilities and
procedures similar to FDA's, but the panel and FDA noted that most
state laboratories may not have excess capacity to perform testing.
* Use private testing laboratories to assist in screening seafood
samples. Our expert panel said, however, that FDA would first need to
develop and implement an appropriate accreditation program. FDA
recognizes that it would get quicker results if it adopted this option
but noted that doing so would require more agency oversight, thereby
making this a costly alternative.
* Develop a program for using private, independent inspectors (third-
party 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.[Footnote 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 food-poisoning 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.[Footnote 7]
Several types of hazards can cause seafood-related illnesses.
Specifically:
* Biological hazards--include pathogens, such as Clostridium botulinum,
Listeria monocytogenes, Salmonella species, and Staphylococcus aureus,
and parasites such as roundworms and tapeworms.
* 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,[Footnote 8] including gastrointestinal and neurological
problems. These toxins are heat resistant and cannot be inactivated by
cooking.
* Physical hazards--include foreign objects in food that can cause harm
when eaten, such as glass or metal fragments.
Figure 1 shows the steady growth in U.S. consumption and imports of
seafood between 1993 and 2002. According to data from the NOAA's
National Marine Fisheries Service, the United States imported about 4.2
billion pounds, or more than 80 percent, of its seafood in 2002, as
shown in the figure.[Footnote 9]
Figure 1: U.S. Seafood Consumption and Imports, 1993 to 2002:
[See PDF for image]
[End of figure]
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.[Footnote 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.
Figure 2: Percentage of Seafood Imports to the United States from Major
Exporting Countries, 2002:
[See PDF for image]
[End of figure]
A large and rapidly growing proportion of worldwide seafood production,
including U.S. imports, is produced by aquaculture. In 2000,
aquaculture represented about 27 percent of global seafood production,
and has increased by an average of 9.2 percent annually since 1970,
compared with only an average 1.4 percent increase for captured
seafood, according to the Food and Agriculture Organization of the
United Nations. As in other animal production systems, aquaculture
producers may use antibiotics and other chemicals to prevent or treat
disease. Some producers have been found to misuse approved drugs or to
use unapproved drugs or chemicals that pose potential human health
hazards, such as antibiotic resistance, allergic reactions, or cancer.
In recent years, food safety authorities in Europe, Canada, and the
United States have begun to detect these substances and are taking
steps to control their illegal use.
FDA is responsible for ensuring the safety of both domestic and
imported seafood under the Federal Food, Drug, and Cosmetic Act. In
1997, 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 seafood-
processing firms responsible for identifying harmful microbiological,
chemical, and physical hazards that are reasonably likely to occur and
for establishing critical control points (CCP) to prevent and reduce
contamination. The HACCP system is based on the following seven
principles that each seafood firm must address:
* Conduct a hazard analysis. Identify hazards that are reasonably
likely to occur.
* Identify the CCP. Identify a point, step, or procedure in the
production process where controls can be applied to prevent, eliminate,
or reduce to an acceptable level a food safety hazard that is
reasonably likely to occur.
* Establish critical limits for each CCP. Set the maximum or minimum
value at which parameters, such as cooking time and temperature, must
be controlled at each CCP to prevent, eliminate, or reduce the hazard
to an acceptable level.
* Monitor each CCP. Establish monitoring activities that will ensure
that the process is under control at each CCP.
* Establish corrective actions. Define actions to be taken when
monitoring discloses a deviation from established critical limits.
* Establish verification procedures. Establish verification procedures
to ensure that HACCP plans accomplish their intended goal--that is,
ensuring the production of safe products.
* Establish record-keeping and documentation procedures. Maintain
documentation, including the HACCP plan; CCP monitoring; corrective
actions; and verification activities.
Under the HACCP regulations, seafood-processing firms are responsible
for conducting a hazard analysis and for developing and implementing
HACCP plans for hazards that are determined to be reasonably likely to
occur. These hazards may include marine toxins, microbiological
contamination, chemical contamination, pesticides, drug residues,
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.[Footnote 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 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.[Footnote 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-of-entry 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 its 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.
Figure 3: Status of FDA's Program Approaches for Ensuring the Safety of
Imported Seafood, Fiscal Years 1999 and 2002:
[See PDF for image]
[End of figure]
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:
[See PDF for image]
[A] Approved foreign processor lists may serve as meeting the
continuing certification affirmative step.
[End of figure]
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.[Footnote 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.[Footnote 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).[Footnote 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.
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.[Footnote 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.
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.[Footnote 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.[Footnote 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 and audits in these countries.
[Footnote 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.[Footnote 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 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.[Footnote 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.
FDA issues untitled letters when the documented violations do not meet
the criteria for detention.[Footnote 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.[Footnote 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 delays in issuing warning letters when serious violations
are identified.[Footnote 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:
[See PDF for image]
[A] FDA's requirement is to issue warning letters within 30 work days
(or about 45 calendar days).
[End of figure]
Fourteen of these 20 warning letters were issued to firms producing
high-risk products[Footnote 25]--such as semipreserved fish products,
including smoked, 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.[Footnote 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-of-entry 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
scombrotoxin-susceptible 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 found that FDA does not prioritize enforcement
actions when violations that pose the most serious public health risk
occur or have an automated system for tracking the time involved in
documenting, reviewing, and processing enforcement actions. As a result
of increased funding, FDA recently increased the number of personnel
responsible for reviewing and issuing these letters and expects to
substantially increase its timeliness. Additionally, FDA is in the
early stages of developing an automated system that will track the time
involved in documenting, reviewing, and processing enforcement actions.
Options Are Available for Enhancing FDA's Imported Seafood Safety
Program, but They Present Challenges:
Several options could help FDA overcome some of the problems we
identified with its current regulatory approach for ensuring the safety
of imported seafood. These options could also help to augment FDA's
inspections of foreign seafood firms, port-of-entry product
examinations, and testing of imported seafood. However, each option
presents certain challenges that FDA would need to address. First, NOAA
could provide staff from its Seafood Inspection Program to augment
FDA's inspections capabilities, and FDA is considering the advantages
and disadvantages of doing so. However, some FDA officials are
concerned about the cost of using NOAA and about a perceived conflict
of interest because NOAA's inspections are fee-for-service. Second, FDA
could contract with state regulatory laboratories to augment its
current capacity to analyze imported seafood samples, but our expert
panel and FDA officials said that most state laboratories might not
have excess capacity to assist FDA. Third, FDA could use private
laboratories to assist in screening seafood samples, provided that FDA
first attests to the laboratories' capabilities to perform the work.
Finally, if it has the authority, FDA could use third-party inspectors
to conduct HACCP inspections of foreign processing firms and domestic
importers; however, FDA would need to certify the inspectors'
competency. FDA has not undertaken a comprehensive review of its legal
authorities in this area.
NOAA's Seafood Inspection Personnel and Laboratories Could Augment
FDA's Regulatory Program:
NOAA officials said that they could assist FDA by providing various
services to augment FDA's regulatory program for imported seafood.
These services include:
* foreign firm inspections,
* HACCP training,
* domestic importer inspections,
* port-of-entry inspection and product sampling, and:
* assistance in developing and verifying equivalence or other types of
agreements with seafood exporting countries.
NOAA officials also said that they could conduct some domestic seafood
inspection services that FDA currently conducts, which would allow FDA
to refocus some of its resources on imported seafood. For example, NOAA
inspectors could certify domestic seafood products shipped to the
European Union and other countries, which is a service that NOAA
provided in the past on a fee-for-service basis. Also, FDA and NOAA
could agree to recognize NOAA's current inspections of approximately
240 domestic processing firms and authorize NOAA to inspect other
domestic firms for compliance with HACCP. NOAA officials estimate that
they could provide FDA with up to 22 full-time-equivalent field
inspectors as well as additional technical support staff in its
headquarters office.
In addition, NOAA and FDA officials are now negotiating the terms of an
agreement to use two NOAA laboratories to screen imported shrimp
samples for the antibiotic chloramphenicol. FDA is taking this action
to increase its testing capacity in response to the detection of the
drug in imported shrimp by food safety authorities in Europe, Canada,
and some U.S. states. Chloramphenicol is banned for use in food-
producing animals because there is no known safe level for human
ingestion of this substance. If the negotiations succeed, FDA would
increase its screening capacity by 400 samples per year.[Footnote 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 appropriated funds. Also, FDA-sponsored inspector
training and periodic audits of NOAA activities could further address
such perceptions. FDA officials also pointed out that it would have to
incur costs to provide training to NOAA inspectors and would have to
develop an agreement with NOAA specifying how NOAA would conduct
inspections and investigations on FDA's behalf. We agree that FDA would
need to incur additional costs to use NOAA inspectors and laboratories,
but these costs may be less than those FDA would incur if the agency
were to hire and train investigators and laboratory analysts without
prior seafood experience.
State Regulatory Laboratories Have the Capability, but May Not Have the
Capacity, to Assist FDA:
FDA is testing only a small fraction of the seafood entering the United
States, about 1.2 percent in fiscal year 2002. Our panelists and past
GAO reports have stated that port-of-entry laboratory testing is an
ineffective "overall" approach for ensuring the safety of imported
seafood. Nevertheless, our panelists believed that increased testing is
desirable as one approach for verifying the presence of biological,
chemical, or drug residues. Therefore, they stated that using state
regulatory laboratories to augment FDA's seafood testing, such as state
Departments of Health or Agriculture, would be beneficial because:
* state laboratories are well equipped for food testing and provide
reliable results,
* these laboratories have procedures in place that could meet FDA's
standards for compliance testing, and:
* FDA's use of state laboratories could improve coordination and
information exchange regarding seafood-testing results between state
laboratories and FDA.
However, the panelists noted a disadvantage to using state regulatory
laboratories. Many states are financially constrained and therefore may
not have the excess capacity, equipment, time, or qualified analysts to
assist FDA. Furthermore, if FDA were to consider using state
laboratories to assist with port-of-entry testing, it would have to
ensure that all laboratories are using appropriate sampling and testing
methodology.
While FDA laboratory officials agreed that using state regulatory
laboratories could be beneficial, they expressed some concerns
regarding using the laboratories to support FDA regulatory action. FDA
officials agreed that state regulatory laboratories are likely to have
established 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.[Footnote
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 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-of-entry 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-of-entry examinations and sample collections, and
laboratory analyses.
To strengthen FDA's current imported seafood program and ensure the
safety of seafood consumed in the United States, the Commissioner of
FDA should take the following five actions:
* make it a priority to establish equivalence or other similar types of
agreements with seafood-exporting countries, starting first with
countries that have high-quality food safety systems;
* develop and implement a system to track the time involved in
documenting, reviewing, and processing regulatory and enforcement
actions, such as issuing warning letters and detaining unsafe products,
so that FDA can identify the reasons for the delays and take actions to
address them;
* give priority to taking enforcement actions when violations that pose
the most serious public health risk occur;
* consider the costs and benefits of implementing an accreditation
program for private laboratories; and:
* explore the potential of implementing a certification program for
third-party 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
seafood-exporting 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 [Hyperlink, 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.
Signed by:
Lawrence J. Dyckman:
Director, Natural Resources and Environment:
[End of section]
Appendixes:
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,[Footnote 29] 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 product[Footnote 30] during fiscal year 2002. The 96
inspections were associated with a total of 112 Forms 3502.[Footnote
31]
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 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 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.
[End of section]
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:
* Haejung An, Associate Professor, Department of Nutrition and Food
Science, Auburn University;
* Tom Chestnut, Vice President, Total Quality, Darden Restaurants;
* Bob Collette, Vice President, Science and Technology, National
Fisheries Institute;
* Cameron Hackney, Dean, Davis College of Agriculture, Forestry and
Consumer Sciences, West Virginia University;
* Michael Jahncke, Director, Virginia Seafood Agricultural Research and
Extension Center, Virginia Polytechnic Institute and State University;
* Michael Moody, Professor and Head, Department of Food Science,
Louisiana State University;
* W. Steven Otwell, Professor, Seafood Technology, Department of Food
Science and Human Nutrition, University of Florida;
* Barbara Rasco, Associate Professor, Department of Food Science and
Human Nutrition, Washington State University; and:
* Caroline Smith DeWaal, Director, Food Safety Approach, Center for
Science in the Public Interest.
Summary of Panel Observations:
On July 2, 2003, we held an all-day meeting with the nine panelists at
our office in Washington, D.C. Before the meeting, we provided each
panel member with a set of four general discussion questions. At the
end of each discussion, we asked the panelists to respond, using an
anonymous ballot, to a set of questions that were based on the general
discussion topics. We recorded and transcribed the meeting to ensure
that we accurately captured the panel members' statements. The
panelists discussed two overarching themes: (1) changes that FDA has
made to improve its ability to ensure imported seafood safety and (2)
options for improving FDA's current regulatory approach.
FDA's Recent Changes:
Since our last report on this matter in 2001, FDA has made changes to
its approach for ensuring the safety of imported seafood. Panelists
specifically discussed these changes, including (1) a shift in focus
from inspecting foreign countries' entire food safety systems for
equivalence to inspecting more foreign firms for HACCP compliance, (2)
a slight increase in the number of port-of-entry examinations and
laboratory testing of imported seafood, and (3) an increase in testing
for aquaculture drug residues. Specifically:
* Panelists suggested that inspecting a small number of foreign firms
for HACCP compliance, rather than inspecting foreign countries' entire
food safety systems for equivalence, is ineffective because FDA only
inspects about 100 seafood firms in 10 countries annually, out of a
universe of an estimated 13,000 firms in about 160 countries.
* Panelists believed that increasing the number of port-of-entry
examinations and laboratory testing for imported seafood, while
desirable, would be ineffective because this approach is not consistent
with the preventative HACCP approach.
* Because regulatory authorities around the world are increasingly
finding aquaculture drug residues, the panelists believed that more
testing for drug residues would be a valuable verification step in an
effective HACCP system. Furthermore, panelists believed that FDA should
shift its focus to the source of production to prevent the abuse of
legal substances or the use of banned aquaculture drugs.
Options for Improving the Current Regulatory Approach:
Overall, panelists believed that FDA's approach to ensuring the safety
of imported seafood should address problems before products reach U.S.
ports of entry. They did not suggest providing FDA with more resources
or eliminating any component of the agency's current approach (e.g.,
port-of-entry examination and testing, foreign firm inspections, and
importer inspections). However, the panelists did stress the need for
FDA to rearrange its approach, placing more responsibility for ensuring
product safety on foreign governments, and to focus its available
resources on ensuring that imported seafood is processed under
effective HACCP systems. Therefore, the panelists recommended that FDA
explore several options to enhance its regulatory approach, including
the following:
Equivalence Agreements:
* Panelists recommended that FDA establish equivalence agreements in
order to more efficiently utilize its limited resources. They believed
that equivalence agreements would be more effective than FDA's direct
inspection of foreign firms for ensuring HACCP compliance and would
also allow the agency to focus resources on the countries, firms, and
products that pose the greatest risk, thereby shifting the burden for
HACCP compliance from FDA to foreign governments and foreign firms.
Panelists stated that such agreements should not imply that FDA must
find a foreign government's seafood safety system "equal" to that of
the U.S. system. For example, panelists said that FDA should have
flexibility in terms of what it considers equivalent and should also
consider alternatives to country-to-country agreements (e.g., product-
to-country, company-to-country, and hazard-specific agreements).
* The panel recommended that FDA first consider one-way equivalence
agreements, with counties where the United States imports large
quantities of seafood but does not export significant quantities.
Although panelists noted that two-way agreements are preferred, they
believed that using one-way equivalence agreements initially would
better ensure that foreign firms are meeting U.S. standards. However,
U.S. seafood exporters may object to one-way agreements, arguing that
these would favor the foreign countries, which may have barriers to
U.S. exports.
* Panelists recommended that FDA establish a timeline for agreements,
although there was no consensus on the best way to develop this
timeline. Possible suggestions included a phased-in process, based on
the quantity of exports to the United States, and the establishment of
agreements based on the willingness of participants.
* Panelists believed that Congress should mandate that FDA establish
equivalence agreements; however, FDA should be allowed to determine how
the agreements are structured and implemented. The panel also expressed
concern that our trading partners could view mandating equivalence as
protectionist. Additionally, panelists said FDA should still implement
third-party certification and auditing if equivalence is mandated.
* The panel believed that FDA should provide additional training and
education to foreign governments and foreign firms on HACCP
requirements, and that industry should pay for this training.
Importer Inspections:
* Panelists recommended that FDA identify competent inspection
authorities to establish lists of preferred suppliers, in which the
foreign government inspects firms wishing to export to the United
States, to assure the agency that these firms meet HACCP requirements.
By adopting this approach, FDA could then target inspection and testing
resources to nonpreferred suppliers.
* Panelists recommended that FDA develop an accreditation program for
private laboratories that demonstrate compliance with FDA's testing
methodologies. FDA could then establish a list of approved, accredited
domestic laboratories to augment their port-of-entry testing for
compliance and enforcement. Additionally, domestic importers could use
the accredited foreign and domestic laboratories to demonstrate,
through testing, that their seafood products were processed in
accordance with HACCP requirements. Panelists believed that most
domestic private laboratories are capable of meeting FDA's standards,
such as sample chain-of-custody, laboratory procedure, and qualified
analysts, and could provide timely results.
Foreign Firm Inspections:
* Panelists recommended that FDA establish a standardized program to
certify private, third-party inspectors to conduct HACCP inspections of
foreign processing firms and domestic importers. The third-party
inspectors would be paid for by industry and monitored by FDA, thereby
allowing for more foreign firm and importer inspections at little
additional cost to FDA.
* Panelists recommended that FDA place more responsibility on foreign
governments to ensure that foreign firms are aware of, and are meeting,
their responsibilities under HACCP. Under an effective HACCP system,
the panelists felt that FDA's emphasis should be on inspection and
testing in the foreign country where the seafood is harvested and
processed and where hazards are introduced.
* Panelists recommended that when problems are discovered as a result
of inspections of foreign firms or importers, FDA should discuss with
the exporting countries how to prevent these problems from reoccurring.
Port-of-entry Examinations and Testing:
* Panelists suggested that state regulatory laboratories (e.g., those
operated by the state Department of Health or Agriculture) may be a
good option for assisting FDA in testing imported seafood products,
particularly in those states with ports and seafood industries. State
laboratories provide comparable testing for state regulatory
authorities and have procedures in place that could meet FDA's
standards for compliance testing. State laboratories are also well
equipped for food testing and provide reliable results. Panelists did
note, however, that most states are financially constrained, and
therefore state laboratories may not have any excess capacity (e.g.,
qualified analysts, equipment time, or laboratory space) to analyze
additional samples for FDA. Furthermore, in order to use the
facilities, FDA would need to harmonize testing methodologies.
* Panelists suggested that FDA use the National Marine Fisheries
Service laboratories in Pascagoula, Mississippi, and Seattle,
Washington, to augment testing at ports of entry. Panel members
believed that this was a good option for FDA because these laboratories
currently conduct seafood research and testing.
* Panelists did not recommend that FDA use academic laboratories for
testing at ports of entry. They stated that most academic laboratories
are not structured to do compliance testing and would not meet FDA's
standards for chain of custody of the samples or acceptable
documentation for compliance or enforcement actions.
[End of section]
Appendix III: Results of GAO Analysis of FDA's Inspections of 99
Foreign Firms, Fiscal Year 2002:
Firms; All firms: With a HACCP plan as required[A];
Number of inspections: 93.
Firms; All firms: Not required to have a HACCP plan;
Number of inspections: 5.
Firms; All firms: Processing high-risk seafood;
Number of inspections: 66.
Firms; All firms: Processing high-risk seafood with HACCP plans[A];
Number of inspections: 65.
Firms; All firms: Found to have serious violations by FDA[A];
Number of inspections: 40.
Firms; All firms: Placed on detention;
Number of inspections: 6.
Firms; Firms processing high-risk seafood: With adequate HACCP plans;
Number of inspections: 10.
Firms; Firms processing high-risk seafood: With inadequate HACCP
plans[A];
Number of inspections: 55.
Firms; Firms found to have serious HACCP violations: Issued a warning
letter;
Number of inspections: 20.
Firms; Firms found to have serious HACCP violations: Issued an
untitled letter[B];
Number of inspections: 14.
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.
One foreign processor did not have a HACCP plan as required.
[B] Of the remaining 6 firms found to have serious HACCP violations, 1
firm no longer ships to the United States, 1 firm's case is still being
reviewed, and 1 firm's warning letter was never issued; FDA is
considering possible reinspection of this firm. For the remaining 3
firms, FDA officials said that they have no record of receiving the
inspection reports.
[End of table]
[End of section]
Appendix IV: Comments from the Food and Drug Administration:
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service:
Food and Drug Administration:
Rockville MD 20857:
January 8, 2004:
Lawrence J. Dyckman:
Director, Natural Resources and Environment:
United States General Accounting Office:
441 G Street, NW
Washington, DC 20548:
Dear Mr. Dyckman:
Please find the enclosed comments from the Food and Drug Administration
on the GAO draft report entitled, FOOD SAFETY: FDA's Imported Seafood
Safety Program Shows Some Progress but Further Improvements are Needed.
(GAO-04-246). The Agency provided technical comments directly to your
staff.
We appreciate the opportunity to review and comment on this draft
report before its publication as well as the opportunity to work with
your staff in developing this report.
Signed by:
Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs:
Enclosure:
General Comments by the Department of Health and Human Service's Food
and Drug Administration (FDA) on the General Accounting Office's (GAO)
Draft Report, FOOD SAFETY. FDA's Imported Seafood Safety Program Shows
Some Progress but Further Improvements are Needed (GAO-04-246):
FDA appreciates the opportunity to comment on GAO's draft report that
focuses on FDA's imported seafood safety program.
We have some general comments regarding the recommendations, and the
overall report, as follows:
General Comments:
The draft report indicates that headquarters' officials stated that
"...the agency does not track the time for reviewing these [Warning
Letter and Untitled Letter] recommendations....":
This statement is not accurate. The Agency does track Warning Letter
and Untitled Letter recommendations, but currently must manually
compute the time it takes to review these recommendations. We
anticipate that the recently developed compliance action tracking
system, Case Track (referenced below under FDA's comments to
Recommendation #3), will provide a more user friendly and efficient
database to track this type of information. Additional funding for the
continued development and necessary modifications of Case Track will
significantly impact the timeframe on when this is to be accomplished.
The GAO report implies that seafood has a higher likelihood of causing
foodborne illness than other foods based on a comparison of the number
of reported outbreaks (i.e., two or more illnesses from a single
source) in the United States from seafood-related causes than from meat
or poultry. The statement that seafood is riskier than other foods as
demonstrated by the Centers for Disease Control (CDC) outbreak data was
first aired over a decade ago during public debates over seafood safety
and then repudiated by CDC itself. In correspondence to both FDA and to
the Congress in 1990, CDC stated that data from its Foodborne Disease
Surveillance System alone could not be used to determine whether eating
seafood is more or less dangerous than eating other foods.
There are several reasons why CDC data cannot be used in this way.
Perhaps the most significant of these is the fact that foodborne
illness outbreaks are underreported to CDC, and of those that are
reported, they tend to skew in favor of more easily diagnosable
illnesses, such as ciguatera and scombroid poisoning from seafood,
rather than nonspecific gastrointestinal symptoms caused by other
foods. Other factors include the variability of illnesses contained
within outbreaks, the fact that most foodborne illnesses occur as
sporadic cases rather than as part of outbreaks, and similar factors.
The draft report fails to acknowledge that foodborne illnesses
associated with seafood also include those from recreational and
subsistence fishing over which the Federal government has little or no
control.
There is no reason to believe that commercial seafood is riskier than
other commercial sources of animal protein.
The draft report states that, in the absence of equivalence agreements,
FDA must rely on importer records to determine whether a food in a
foreign country has been produced acceptably. That is incorrect. As GAO
points out elsewhere in the document, FDA relies on:
examination and sampling at ports of entry, overseas inspections of
foreign processing plants, and detention without physical examination
(DWPE), among other things. It is important to recognize that the FDA
seafood HACCP requirement that importers take and document "affirmative
steps" to ensure that U.S. requirements are met was a novel concept
when introduced several years ago. FDA recognized that this concept
would take time to implement successfully and therefore has never
relied on it exclusively as a way to ensure safety. Rather, it is a
relatively new approach that is being integrated into the overall food
safety system.
We do not believe that the GAO report fully captures the basis for
issuing Warning and Untitled Letters. We believe a more accurate
explanation is as follows:
"Once FDA Investigators complete an inspection of a foreign facility or
at a domestic importer, they submit a recommendation and/or report to
headquarters for review and a regulatory decision. FDA issues Warning
Letters and Untitled Letters to inform responsible individuals of
violations found during the inspection. This is consistent with FDA's
practice to afford individuals and firms 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 individuals and firms will voluntarily
comply. The main distinction between the two letters is that a Warning
Letter contains a statement that FDA will consider action if
corrections are not made and demands a written response within a
certain period of time. To ensure Warning Letters address current
conditions, current FDA policy requires that Warning Letters be issued
within four months from the date that the inspection concludes.":
"Untitled Letters do not reference enforcement actions, contain or
demand a response. The use of an Untitled Letter rather than the more
serious Warning Letter may be for a variety of reasons; such as, the
violations observed or deviations at the firm are not of regulatory
significance; the evidence is not current or it is inconclusive; it was
the firm's first inspection; or new rules have been implemented.":
Comments on Recommendations for Executive Action:
1. 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 necessary to begin
using NOAA employees to provide various services. Those services could
include inspections of foreign firms, importer inspections, port-of-
entry examinations and sample collection, and laboratory analyses.
FDA Comment:
The Food and Drug Administration and the National Oceanic and
Atmospheric Administration (NOAH), National Marine Fisheries Service
(NMFS), Seafood Inspection Program have had a long, collegial working
relationship and have been working for some time to better integrate
their programs. We have once again begun a dialog between FDA and NOAA
discussing a possible transfer of the Seafood Inspection Program from
NOAA to FDA. In lieu of such a transfer, FDA will be working with NOAH
to find better ways of integrating its programs with those of the NMFS.
We currently have three Memoranda of Understanding (MOUs) between the
two agencies dealing with seafood safety and inspection operations as
well as an MOU on shellfish growing waters that includes three other
agencies in addition to FDA and NMFS. We also have had multiple
Interagency Agreements that provided joint funding to determine the
effects of fish consumption on human mercury toxicity; the Shellfish
Safety Assistance Project to provide financial support for the
operation of the central office of the Interstate Shellfish Sanitation
Conference; as well as jointly funding with USDA and DOD to support the
National Advisory Committee for the Microbiological Criteria for Foods.
Additionally, the two programs continue to work closely to represent
the United States on issues arising from the Codex Alimentarious
Committee on Fish and Fishery Products. We agree that it is important
to continue to explore if there are additional cooperative activities
either under our existing MOUs or additional agreements that can help
us better leverage NOAA Seafood Inspection Program resources in order
to more efficiently and effectively protect the public health.
The NMFS currently has a program to provide export health certificates
for seafood exporters shipping to the European Union, a service that
FDA also provides at considerable expense. The major difference is that
the NMFS charges the seafood processor who benefits from the service.
While some segments of the seafood industry object to paying fees for
this service, we have been working to develop a pilot program in which
requests for export certificates for live and fresh seafood will be
referred to NMFS. By limiting the burden of providing these perishable
commodity export health certificates, FDA will be able to free up its
limited resources for other seafood activities.
In addition, the recently enacted Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
added a new authority under section 314 to commission other federal
officials to conduct examinations and inspections for facilities that
are regulated under the Federal Food, Drug, and Cosmetic Act and by
another federal agency. We have been reviewing that authority with a
number of different federal agencies to determine what kinds of
programmatic activities might best be achieved by using this newly
established commissioning authority and who might be commissioned. Our
first use and highest priority was the use of this new authority to
commission personnel from the Bureau of Customs and Border Protection
in the Department of Homeland Security to assist with border
inspections. However, FDA has also conducted an initial legal review
and has determined that, under certain circumstances, we can use the
authority under section 314 of the Bioterrorism Act because the
Department of Commerce/NMFS jointly regulates these seafood facilities
with FDA. Now that we have completed our initial legal review and
developed procedures for commissioning, we are in a position to enter
more formal discussions to explore the potential for commissioning of
NMFS inspectors. We have suggested forming a work group to determine if
commissioning could permit NMFS to provide more service to the
industry, increase the value of their inspections, and assist FDA in
meeting its public health responsibilities.
There also may be other opportunities for us to better leverage with
NMFS inspectors where it may be advantageous to get information from
NMFS inspectors, who may already be "on site," rather than having an
FDA inspector travel to a distant location.
Yet another example of increased coordination could be the use of NOAA
laboratory capacity to carry out analyses of seafood samples that FDA
takes during the normal course of our work, or during "crisis"
situations. Specifically for chloramphenicol analysis, we are currently
finalizing an IAG with the NOAA Fisheries' National Seafood Inspection
Laboratory (NSIL) located in Pascagoula, MS and the NOAA Fisheries'
Northwest Fisheries Science Center in Seattle, WA. We hope that such an
agreement may help increase our laboratory capacity, with the potential
fuller utilization of NOAA capabilities. Discussions between the
particular NOAA fisheries facilities have resulted in FDA's
provisional approval (pending on site review) of these laboratory's
methods for sample submission, custody, routing, and accounting and
documentation procedures necessary to maintain the regulatory chain of
custody and tracking required for import collections. FDA is still
awaiting our FY04 budget to determine if we will be able to fund these
proposals.
Finally, FDA has long explored the potential that could be obtained by
transfer of the NMFS voluntary, fee-for-service seafood inspection
program to FDA. The transfer of the program from one agency to another
would require legislation. A bill to transfer this program was
transmitted to the Congress in 1999 but a sponsor could not be found
and thus the bill was never formally considered. We are not aware of
any current Congressional effort to provide for such a realignment.
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:
2. 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.
FDA Comment:
In light of the pressing FDA priorities associated with implementation
of the provisions of the Bioterrorism Act, and for the reasons
described below, FDA is not currently positioned to assign high
priority to negotiating equivalence or similar types of agreements with
the numerous countries that are currently exporting seafood to the
United States. However, the agency is aware that in some specific
situations, formal agreements with governments of seafood exporting
countries can enhance the assurances of safety for seafood exported to
the United States. The agency has established a number of such
agreements pertaining to seafood safety, six of which are currently
operative. All current seafood safety agreements are longstanding
"compliance-based" agreements, rather than equivalence agreements,
whereby the governments of the exporting countries have agreed to
undertake certain regulatory and administrative actions, or to
otherwise put safety measures into place, that provide FDA with
reasonable assurance that seafood exported to the United States
complies with applicable U.S. requirements. Five of these involve raw
molluscan shellfish, under which a foreign country agrees to comply
with the rather complex requirements of the U.S. National Shellfish
Sanitation Program.
Under some circumstances, these types of compliance agreements can be
useful components in the overall food safety effort, at least in the
control of specific seafood safety hazards. The agency notes, however,
that negotiation and establishment of formal compliance agreements with
other governments is extraordinarily resource intensive. In general,
FDA would not be positioned to accept seafood safety assurances from
exporting countries unless and until the agency conducts a credible
assessment of the exporting country's seafood safety system, both as it
exists "on paper" and as it is being implemented, in practice,
specifically to guarantee compliance with U.S. requirements. This
process currently requires expenditure of very significant time,
personnel and monetary resources by FDA. Nonetheless, FDA intends to
review the potential scope(s) of such agreements, targeted toward
specific issues and problems, and the extent to which they could be
beneficial and provide possible resource efficiencies and savings in
the long run. There is no timetable for this review, however, because
for the current fiscal year, at least, the agency lacks resources to
engage in overseas evaluations of foreign regulatory systems - an
essential prerequisite for any agreement.
As with compliance agreements, FDA agrees that equivalence agreements,
in principle, can be effective in specific cases to enhance seafood
safety. However, the agency does not believe that equivalence
agreements, applied broadly to many exporting countries, would enhance
seafood safety markedly or would be practicable from a resource
perspective.
Within the context of the World Trade Organization Agreement on the
Application of Sanitary and Phytosanitary Measures (WTO SIPS
agreement), the concept of equivalence is envisioned as a means for
exporting countries to gain otherwise blocked or inhibited market
access, if they are able to demonstrate satisfaction of the importing
country's "appropriate level of protection". In the case of most
seafood exported to the United States , the "otherwise blocked or
inhibited" condition is not applicable. Under the laws FDA administers,
an affirmative governmental demonstration of either compliance or
equivalence for seafood as a precondition for market access is not
required. Consequently, governments of exporting countries are not
mandated:
to affirmatively demonstrate to FDA compliance or equivalence of their
seafood products as a condition for market access. Thus, there is
little apparent market access incentive for exporting countries, in
general, to seek an FDA evaluation or finding of equivalence. FDA
recognizes, however, that all WTO Members are required to engage in
discussions on equivalence if so requested by another Member. In this
regard, FDA has discussed and would be prepared to discuss potential
seafood equivalence options if so requested by an exporting country's
government.
As with compliance agreements, the process by which equivalence
agreements are established, even for countries with sophisticated
seafood safety systems, is extraordinarily resource intensive. The
process of "paper review" and on-site evaluation of an exporting
country's seafood safety system or its individual seafood safety
measures, may take several years and very large expenditures of staff
and monetary resources to complete. Once FDA completes such an
equivalence evaluation, and if the agency makes a determination of
equivalence, it must, according to provisions of the Uruguay Round
Agreements Act, go through notice and comment.
As the United States has stated within the WTO SIPS Committee during
that Committee's recent deliberations on WTO Members' implementation of
the concept of equivalence, the practical benefits of equivalence
agreements, in terms of public health protection or trade facilitation,
may not be worth the costs associated with the process. In fact,
outside of specific situations, such as those bearing on meat and
poultry safety, where equivalence is mandated as a condition for market
access, very few equivalence agreements have been established by other
WTO Members.
As noted by GAO, the Codex Alimentarius Commission (Codex) has very
recently established guidelines to facilitate all countries'
understanding and practical implementation of the concept of
equivalence. The United States, and FDA in particular, was instrumental
in developing these important international guidelines which can now be
used in those cases where a formal equivalence evaluation process
appears to be warranted as a necessary means of trade facilitation.
FDA, in cooperation with other U.S agencies, intends to utilize these
new international guidelines as a framework for establishing workable
FDA equivalence criteria for foods. In so doing, FDA will look
carefully for means to make the equivalence evaluation process as
efficient as possible, such that it can be used effectively in those
situations where it is actually warranted.
3. 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 the agency can identify the reasons for the delays and take
actions to address them.
FDA Comment:
FDA recognizes the need to strengthen its tracking and processing of
establishment inspection reviews, and in 2001 began the development of
the Compliance Action Case Track System (Case Track) for foreign and
domestic case reviews. Case Track is a computerized system which has
capabilities that address the areas of concern identified in the GAO
Report.
In 2002, FDA initiated a pilot of the computerized system for
processing and tracking domestic cases. In 2003, FDA transitioned all
domestic cases under the new Case Track system.
FDA is currently working with contractors on the parameters needed to
complete the next phase of incorporating foreign case processing and
tracking into the system, as well as creating a tickler mechanism that
provides notification to the case reviewer when timeframes are
approaching. FDA anticipates completion of the imports transitional and
implementation phase and tickler system by the Spring of 2004.
Additional funding for the continued development and necessary
modifications of Case Track will significantly impact whether the
projected timeframe is met.
In addition, the agency field components use the Field Accomplishments
and Compliance Tracking System (FACTS) to track the time involved in
preparing, receiving, and processing regulatory and enforcement
actions. FACTS is an FDA agency-wide database that provides the ability
to request and manage field work assignments and record work results
(from assign-ments through compliance actions).
The field compliance components use FACTS to record details and events
which take place during handling of compliance actions such as Warning
Letters and enforcement actions. FACTS provides the ability for the
chronological record of a case to be maintained and monitored.":
4. Give priority to taking enforcement actions when violations that pose
the most serious public health risk occur.
FDA Comment:
Because of the limited resources available for foreign seafood
inspection, FDA assures that inspectional efforts are generally
directed at those firms representing the greatest risk. FDA considers a
number of risk factors in identifying firms for coverage. These factors
include:
Firms producing products known to present specific hazards:
Firms in countries that are significant sources of product for U.S.
markets Firms in countries that may pose safety or security concerns:
Firms in countries with known infrastructure problems:
Firms producing products shipped in large quantities into the U.S. or
shipped in smaller quantities but intended for vulnerable populations:
Firms with identified problems.
In this respect, FDA's HACCP-based foreign compliance inspections are
prioritized in advance. It is important to recognize that the
violations found during these inspections do not typically involve a
finding of contaminants in the products being shipped to the United
States. Rather, they involve a finding that better preventive controls
are needed to ensure that there will not be contaminants in the
products in the future. For those reasons, FDA has not typically
prioritized the results of one inspection over another; rather, the
agency believes it is important to take action on all of the findings
in a timely manner. FDA acknowledges that it needs to improve in that
area. Because HACCP-based foreign compliance inspections are
relatively new and are being performed in addition to traditional
activities, it has not always been easy to manage the process as
expeditiously as the agency would prefer.
Once a firm has been identified for inspection as a high risk, FDA
remains committed to taking strong, prompt enforcement when violations
are found. In this regard, ORA and CFSAN managers agreed to reinforce
with their respective staffs the importance of timely foreign
inspection reports and followup. Additionally, FDA is moving towards
more use of Detention Without Physical Examination (DWPE) rather than
Warning Letters and Untitled Letters. In accordance with FDA guidance
implementing section 801 (a) of the Federal Food, Drug, and Cosmetic
Act (FD & C Act), FDA lists a foreign firm's product(s) on an Import
Alert to notify the field that the firm's products are subject to
refusal of admission. The products are subject to refusal of admission
until the violations found during the inspection are corrected. The use
of DWPE in this context is one way of expediting the corrective action
to achieve compliance.
5. Consider the costs and benefits of implementing an accreditation
program for private laboratories.
FDA Comment:
The question of FDA becoming an accreditation body and implementing an
accreditation program for non-FDA laboratory testing requires an
objective analysis to fully address all the issues, including the costs
and benefits. While FDA believes that such a study may be valuable, our
current priorities are focused on full implementation of the new food
safety and security authorities contained in the Bioterrorism Act. As
these priorities permit, FDA will:
* Conduct a preliminary review of the legal authorities relating to the
adoption and implementation of an accreditation program for non-FDA
laboratory testing of imported seafood. This analysis would identify the
applicable legal authorities, if any, that we currently have and
whether additional authorities are needed.
The review would be followed up with a study that would examine a
variety of issues including examining the scope of accreditation that
could be offered by FDA and attendant costs and benefits, both
quantifiable and unquantifiable, of implementing different options.
Other legal or administrative obstacles may be identified through these
assessments and during the cost/benefits evaluation.
Update on Status of Federal, State Laboratory Testinq:
FDA currently is evaluating several federal and state laboratory
testing initiatives. At this time these initiatives are limited to
analysis of import seafood collected by the FDA. FDA is currently
negotiating with three outside laboratories to test official FDA
imported seafood samples for the presence of chloramphenicol.
Federal Laboratory --NOAA:
Two NOAA proposals have been received, reviewed and are in final stage
of approval by the FDA and NOAA authorities. The participating NOAA
laboratories will screen import shrimp:
samples collected by the FDA for the presence of chloramphenicol (CAP).
The screening test performed by the laboratories is not sufficient to
support FDA regulatory action; CAP detected by the screening test will
be regarded as presumptive and FDA will perform more definitive
confirmation testing before taking regulatory action . The NOAH
laboratories are not equipped to perform confirmation testing; the
laboratories will enhance FDA testing capacity by identifying import
entries free of CAP residues and reducing the testing required by the
FDA to confirm a presumptive finding of CAP residues.
The NOAA proposals include funding by the FDA for personnel, equipment,
and use of facilities; the agreements will be signed and implemented
upon FDA approval of funds. FDA will also assume additional expenses
(not identified in the proposals) for training, oversight, and
confirmation testing.
The duration of the NOAA proposals are limited to one fiscal year of
screening imported seafood; FDA and NOAA will evaluate agreement in
final quarter and modify, restructure, or terminate for FY05 as
warranted.
State Laboratory --FDACS:
FDA is currently in discussion with Florida Department of Agriculture
and Consumer Services (FDACS) to establish an agreement providing state
assistance with testing of imported shrimp for CAP residues. FDACS will
also receive official FDA collections of imported shrimp for screening
and confirmation testing. FDA intends to identify firms for regulatory
action based on state testing.
FDACS expects to request funding from the FDA to implement a testing
agreement. No testing levels or costs have been identified. FDA will
assume additional expenses for oversight and monitoring of the state
laboratory testing. The state testing would add additional capacity by
permitting regulatory action based on state findings.
6. Review its legal authorities and consider the costs and benefits of
implementing a certification program for third-party inspectors.
FDA Comment:
FDA believes that a third party inspection and certification program to
monitor the safety of imported seafood may hold potential promise to
enhance FDA's seafood safety program, but notes that, as with
laboratory accreditation, the cost and benefits must be identified and
considered. As resources permit, the agency intends to identify and
consider the costs and benefits of implementing a certification program
for third party inspectors of imported seafood, as well as begin a
review of legal authorities relating to the adoption and implementation
of such a certification program.
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.[Footnote 32]
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.
[End of section]
Appendix V: Comments from the National Oceanic and Atmospheric
Administration:
UNITED STATES DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
OFFICE OF FINANCE AND ADMINISTRATION:
JAN 13 2004:
Mr. Lawrence J. Dyckman
Director, Natural Resources and Environment:
United States General Accounting Office
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Dyckman:
Thank you for the opportunity to review and comment on the General
Accounting Office's draft report entitled, "Food Safety: FDA's Imported
Seafood Safety Program Shows Some Progress but Further Improvements are
Needed," GAO-04-246. The National Oceanic and Atmospheric
Administration does not have any comments on the draft report.
Sincerely,
Signed for:
William F. Broglie:
Chief Administrative Officer:
[End of section]
Appendix VI: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Lawrence J. Dyckman, (202) 512-3841
Maria Cristina Gobin, (202) 512-6526:
Staff Acknowledgments:
In addition to the individuals named above, John C. Smith, Kenya Jones,
and Lisa Vojta made key contributions. Other contributors included,
Aldo Benejam, Oliver Easterwood, Lynn Musser, Cynthia Norris, Paul
Pansini, Katherine Raheb, Carol Herrnstadt Shulman, Sidney Schwartz,
and Kathy Summers.
(360298):
FOOTNOTES
[1] According to the National Marine Fisheries Service, National
Oceanic and Atmospheric Administration, the percentage of imported
seafood is based on live weight.
[2] CDC derives estimates of foodborne illness from, among other
things, reported occurrences of two or more cases of a similar illness
resulting from the ingestion of a common food, which is referred to as
an outbreak. It publishes foodborne disease outbreaks in 5-year
increments. These percentages are based on the most recent CDC data
available, published in March 2000 and covering 1993 to 1997.
[3] Among other things, FDA considers a product to be adulterated if it
contains bacterial contamination or prohibited chemical substances, or
if it has been produced without a HACCP plan.
[4] The Agricultural Marketing Act of 1946 authorized the Seafood
Inspection Program. The program was transferred from the Department of
Agriculture to the Department of the Interior in 1956 and subsequently
to the Department of Commerce in 1970.
[5] U.S. General Accounting Office, Food Safety: Federal Oversight of
Seafood Does Not Sufficiently Protect Consumers, GAO-01-204
(Washington, D.C.: Jan. 31, 2001).
[6] According to CDC, only a fraction of foodborne illnesses are
routinely reported, and since most foodborne illnesses are sporadic,
only a small number of them are identified as being part of an
outbreak.
[7] Outbreaks include those that are linked to finfish; other seafood
(e.g., crab and shrimp); and seafood dishes, which may include
molluscan shellfish (oysters, clams, mussels, and whole or roe-on
scallops).
[8] FDA noted that a number of illnesses from ciguatoxin are from
recreational versus commercial fishing, but the agency did not provide
any specific data.
[9] Consumption data are based on edible portions of seafood from
imported and domestic sources. Import data are based on both edible and
inedible portions of seafood, including bones.
[10] U.S. seafood consumption data include finfish, shellfish, and
other aquatic plants and animals.
[11] World Trade Organization Agreement on the Application of Sanitary
and Phytosanitary Measures, art. 4, 1994.
[12] The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, Pub. L. No. 107-188; 116 Stat. 594 (2002).
[13] To 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.
[14] As 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.
[15] To 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.
[16] FDA 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.
[17] The compliance agreement being discussed with Japan is for
specific seafood products.
[18] Codex is an international food standard-setting body under the
joint oversight of the United Nations Food and Agriculture Organization
and the World Health Organization.
[19] USTR also told us that guidelines completed by Codex in July 2003
are still too abstract for FDA to use to determine equivalence.
[20] Under 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.
[21] FDA 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.
[22] As 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.
[23] FDA 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.
[24] 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 this assignment.
[25] According to FDA, high-risk foods are those that may contain
hazards that the agency believes present a higher potential to cause
harm to humans.
[26] As 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.
[27] FDA 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.
[28] Congress 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.
[29] U.S. General Accounting Office, Food Safety: Federal Oversight of
Seafood Does Not Sufficiently Protect Consumers, GAO-01-204
(Washington, D.C.: Jan. 31, 2001).
[30] To record importer inspection findings, FDA investigators complete
a product-specific standardized form (Form 3502) after each importer is
inspected. The forms indicate whether importers have the required
documentation, and if so, whether it documents the foreign firm's
compliance with U.S. Hazard Analysis and Critical Control Point
requirements. Investigators may choose to inspect documentation for
more than one product and therefore complete more than one Form 3502
during an inspection.
[31] We removed 5 inspections forms that were incorrectly completed.
[32] Procedures for the safe and sanitary processing and importing of
fish and fishery products, 60 Fed. Reg. 65096, 65155 (1995). (Codified
at 21 CFR Pts. 123.12 and 1240.)
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