Seafood Safety
FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources Gao ID: GAO-11-286 April 14, 2011GAO-11-286, Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources
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United States Government Accountability Office:
GAO:
Report to Congressional Requesters:
April 2011:
Seafood Safety:
FDA Needs to Improve Oversight of Imported Seafood and Better Leverage
Limited Resources:
GAO-11-286:
GAO Highlights:
Highlights of GAO-11-286, a report to congressional requesters.
Why GAO Did This Study:
About half of the seafood imported into the U.S. comes from farmed
fish (aquaculture). Fish grown in confined aquacultured areas can have
bacterial infections, which may require farmers to use drugs like
antibiotics. The residues of some drugs can cause cancer and
antibiotic resistance. The Department of Health and Human Services‘
(HHS) Food and Drug Administration (FDA) is charged with ensuring the
safety of seafood against residues from unapproved drugs, and the
Department of Commerce‘s National Marine Fisheries Service (NMFS)
provides inspection services on request. In 2009, these agencies
signed a memorandum of understanding (MOU) to enhance seafood
oversight and leverage inspection resources. GAO was asked to assess
the extent to which (1) FDA‘s program is able to ensure the safety of
seafood imports against residues from unapproved drugs and (2) FDA and
NMFS have implemented the 2009 MOU. GAO reviewed data and documents
from each agency and interviewed agency officials and other key
stakeholders.
What GAO Found:
FDA‘s oversight program to ensure the safety of imported seafood from
residues of unapproved drugs is limited, especially as compared with
the European Union (EU). FDA‘s program is generally limited to
enforcing the Hazard Analysis and Critical Control Point”the
internationally recognized food safety management system”by conducting
inspections of foreign seafood processors and importers each year.
These inspections involve FDA inspectors reviewing records to ensure
the processors and importers considered significant hazards, including
those resulting from drug residues if the seafood they receive are
from fish farms. The inspectors generally do not visit the farms to
evaluate drug use or the capabilities, competence, and quality control
of laboratories that analyze the seafood. In addition, FDA has
conducted foreign country assessments in five countries to gather
information about those countries‘ aquaculture programs. However,
these assessments have been limited by FDA‘s lack of procedures,
criteria, and standards. In contrast, the EU reviews foreign
government structures, food safety legislation, the foreign country‘s
fish farm inspection program, and visits farms to ensure that imported
seafood products come from countries with seafood safety systems
equivalent to that of the EU. In addition, the scope of FDA‘s sampling
program, which supplements its oversight program, is limited.
Specifically, the sampling program does not generally test for drugs
that some countries and the EU have approved for use in aquaculture.
Consequently, seafood containing residues of drugs not approved for
use in the United States may be entering U.S. commerce. Further, FDA‘s
sampling program is ineffectively implemented. For example, for fiscal
years 2006 through 2009, FDA missed its assignment plan goal for
collecting import samples by about 30 percent. In addition, in fiscal
year 2009, FDA tested about 0.1 percent of all imported seafood
products for drug residues. Moreover, FDA‘s reliance on 7 of its 13
laboratories to conduct all its aquaculture drug residue testing
raises questions about the agency‘s use of resources.
FDA and NMFS have made limited progress in implementing their 2009
MOU. The agencies have developed procedures for certain MOU
activities, such as notifying NMFS of pending FDA regulatory actions.
However, because FDA believes NMFS inspectors need training to conduct
inspections according to FDA standards, it has not utilized NMFS‘
inspection resources or results in a systematic manner. Better
leveraging available resources is critical, especially in places like
China, where FDA has inspected 1.5 percent of Chinese seafood
processing facilities in the last 6 years.
What GAO Recommends:
GAO recommends that FDA study the feasibility of adopting practices
used by other entities to better ensure the safety of imported
seafood, enhance its import sampling program, and develop a strategic
approach for enhancing collaboration with NMFS and better leveraging
resources. HHS neither agreed nor disagreed with GAO‘s recommendations
but cited actions in process or planned that are generally responsive
to them.
View [hyperlink, http://www.gao.gov/products/GAO-11-286] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Background:
FDA's Program to Ensure the Safety of Imported Seafood from Residues
of Unapproved Drugs Is Limited, Especially as Compared with the EU:
FDA and NMFS Have Made Limited Progress to Implement the 2009 MOU, and
FDA Has Not Leveraged NMFS Inspection Resources:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: FDA Foreign Facility Inspections and Number of Processing
Facilities in the Country:
Appendix III: FDA Import Alerts Related to Drug Residue or HACCP
Violations:
Appendix IV: Comments from the Department of Health and Human Services:
Appendix V: GAO Contact and Staff Acknowledgments:
Figures:
Figure 1: Top Six U.S. Seafood Import Sources in 2009:
Figure 2: Drugs Approved for Aquaculture by Selected Countries and the
EU That Have a Maximum Residue Limit:
Abbreviations:
EU: European Union:
FDA: Food and Drug Administration:
FSIS: Food Safety and Inspection Service:
HACCP: Hazard Analysis and Critical Control Point:
HHS: Department of Health and Human Services:
MOU: memorandum of understanding:
NMFS: National Marine Fisheries Service:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
April 14, 2011:
The Honorable John D. Rockefeller, IV:
Chairman:
Committee on Commerce, Science, and Transportation:
United States Senate:
The Honorable Olympia J. Snowe:
Ranking Member:
Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard:
Committee on Commerce, Science, and Transportation:
United States Senate:
The Honorable Maria Cantwell:
The Honorable Daniel K. Inouye:
United States Senate:
The United States has increased the amount of seafood it imports over
the past 10 years, currently importing seafood from approximately 130
countries. According to estimates from the Department of Commerce's
National Oceanic and Atmospheric Administration, in 2010 more than 80
percent of seafood consumed in the United States--such as shrimp,
salmon, and tilapia--was imported, with about half coming from
aquaculture (fish farming). Because fish grown in confined
aquacultured areas can have high rates of bacterial infections,
farmers may treat them with drugs, such as antibiotics and antifungal
agents, to increase their survival rates. Once drugs are introduced,
their residue can remain in the fish through harvesting, processing,
and consumption. According to the Department of Health and Human
Services' Food and Drug Administration's (FDA) 2008 Report to
Congress,[Footnote 1] the residues of some drugs can cause cancer,
allergic reactions, and antibiotic resistance when consumed by humans.
As imports of aquacultured seafood products increase, so too do the
concerns over the presence of drug residues.
Under the Federal Food, Drug, and Cosmetic Act, FDA is responsible for
ensuring that the nation's food supply, including imported seafood, is
safe, wholesome, sanitary, and properly labeled.[Footnote 2] Since
1997, when imported seafood first accounted for more than 60 percent
of the seafood consumed in the United States, FDA has used the
internationally recognized Hazard Analysis and Critical Control Point
(HACCP) system as its main safety oversight program for imported
seafood. Under HACCP requirements, seafood processing firms, including
firms that manufacture, pack, or label, are responsible for conducting
a hazard analysis and for developing and implementing HACCP plans
whenever an analysis shows that one or more hazards are reasonably
likely to occur. Food safety hazards may result from, among other
things, drug residues, pesticides, parasites, and decomposition. HACCP
requires (1) food processors to identify and develop strategies to
prevent, eliminate, or reduce to an acceptable level the hazard and
(2) importers to ensure that the products they import have been
processed in accordance with HACCP requirements or that the products
have been obtained from a country with an active agreement with FDA
covering the product that documents equivalence or compliance with the
U.S. system. FDA enforces HACCP requirements related to drug residues
in imported seafood in two main ways. First, FDA inspects a number of
foreign seafood processing facilities each year to ensure they comply
with HACCP requirements. If a processor fails to have and effectively
implement a HACCP plan, its products are considered adulterated and
may be refused entry into U.S. commerce. Second, FDA conducts
inspections at a designated number of U.S. importers each year to
determine if they have maintained the appropriate documents to prove
that the processors from whom they import seafood meet HACCP
requirements. If importers cannot provide assurance that the seafood
products they import have been processed under conditions established
by HACCP requirements, the products are considered adulterated and can
be refused entry into the United States. FDA is not required to
preapprove HACCP plans; however, FDA, not the processors or importers,
is responsible for determining whether processors and importers
adequately comply with seafood HACCP requirements. During facility
inspections for HACCP compliance, inspectors review HACCP plans and
according to FDA officials, determine if the plans are implemented.
Supplementing its HACCP oversight activities, FDA has an import
sampling program that tests imported seafood products at ports of
entry to, among other things, ensure that they do not contain certain
targeted drug residues, including residues of drugs that are
unapproved for use in the United States and render the seafood
adulterated under the Federal Food, Drug, and Cosmetic Act.
In addition to FDA's seafood safety activities, the National Oceanic
and Atmospheric Administration's National Marine Fisheries Service
(NMFS) Seafood Inspection Program provides fee-for-service inspection
services, on request to the seafood industry--including domestic and
foreign processors, distributors, and other firms--to, among other
things, certify that these seafood firms comply with HACCP and other
federal food safety standards. Some retailers require this
certification as a condition for purchasing the seafood products.
In 1974, FDA and NMFS signed a memorandum of understanding (MOU), in
part, to improve the efficient use of FDA's inspection resources by
minimizing the number of FDA inspections at establishments already
inspected by NMFS. We reported in 2005 that FDA had not fully met its
responsibilities under the MOU and that, in some cases, the agency was
continuing to duplicate NMFS inspections. We recommended in that
report that FDA fully meet its responsibilities under the MOU.
[Footnote 3] In that same year, we identified promising practices for
collaboration among federal agencies, stating that collaboration can
occur when they (1) establish procedures and policies for working
together systematically across agency lines and (2) identify ways to
leverage their resources to maximize their effectiveness, among other
things.[Footnote 4] In 2007, we added the federal oversight of food
safety to our list of high-risk areas needing broad-based
transformation, largely because of continued ineffective coordination
and inefficient use of resources.[Footnote 5] In February 2009, we
reported that FDA and NMFS had not yet begun to work together and
recommended that the agencies collaborate to more effectively and
efficiently share information and leverage their inspection resources
to enhance federal oversight of seafood.[Footnote 6] In October 2009,
FDA and NMFS finalized a new MOU that updated the 1974 MOU--the
agencies agreed, in part, to maximize the use of their resources, when
appropriate and as resources permit, by taking advantage of each
others' inspection capabilities.
In this context, you asked us to examine how federal agencies ensure
the safety of seafood, in particular imported seafood, from drug
residues. Specifically, this report addresses the extent to which (1)
FDA's program is able to ensure the safety of seafood imports against
residues from unapproved drugs and (2) FDA and NMFS have implemented
the 2009 MOU to enhance federal oversight of seafood and leverage
federal resources.
To assess the extent to which FDA's program is able to ensure the
safety of seafood imports against residues from unapproved drugs, we
analyzed information on FDA's oversight mechanism for seafood imports--
importer and foreign country processing facilities inspections--and
its seafood import sampling program. In particular, we analyzed
information on the major components and requirements of FDA's importer
and foreign facility HACCP inspections. We analyzed fiscal years 2006
through 2009 data on FDA's import sampling test results and determined
that the data were sufficiently reliable for our purposes. In
addition, we reviewed the European Union's (EU) seafood importing
program to determine if its practices for ensuring the safety of
seafood imports have the potential for enhancing our own practices. We
also reviewed the imported seafood sampling programs of the EU, the
largest importer of seafood worldwide; Japan, the second largest
importer; and Canada, a major provider of seafood to the United
States, to determine if their sampling practices had the potential for
enhancing our own practices as well. Furthermore, we reviewed
oversight practices the Department of Agriculture's Food Safety and
Inspection Service (FSIS) uses to ensure the safety of imported meat
and poultry products for the same purpose. We interviewed
knowledgeable FDA, FSIS, EU, Canadian, and Japanese officials to
obtain more information on how their respective programs function. We
analyzed relevant documents to assess the extent to which FDA and NMFS
have implemented the 2009 MOU to enhance federal oversight of seafood.
We also interviewed knowledgeable FDA and NMFS officials to determine
their progress in implementing the 2009 MOU. (See appendix I for
additional information on our scope and methodology.)
We conducted this performance audit from April 2010 to April 2011 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
Background:
Fishery products, including wild catch, aquaculture, and processed
fish products, are one of the most traded commodities in the world
today. More than half of this commodity originates in developing
countries, and almost 75 percent of it ends up either in the EU,
Japan, or the United States. Not only is the United States importing
more of the seafood it consumes today than it did 10 years ago, but
more of those imports are from fish farms. Currently the United States
imports 84 percent of the seafood consumed, and about 50 percent of it
is from aquaculture. Figure 1 shows the proportion of imports to the
United States from the top six countries exporting seafood to the
United States.
Figure 1: Top Six U.S. Seafood Import Sources in 2009:
[Refer to PDF for image: highlighted world map]
China: 23%;
Thailand: 16%;
Canada: 13%;
Indonesia: 6%;
Vietnam: 5%;
Ecuador: 5%;
All others: 33%.
Source: GAO analysis of Department of Commerce and International Trade
Commission data.
Note: Percentages do not add up to 100 percent due to rounding.
[End of figure]
Concerns regarding the use in aquaculture operations of veterinary
drugs that are unapproved in the United States and the misuse of
approved drugs have increased substantially as the aquaculture
industry has grown, according to FDA documents. While antimicrobials,
including antibiotics, are used to treat diseases in animals,
including seafood, the use of unapproved antibiotics in aquaculture
has raised significant public health concerns. For example,
nitrofurans are specifically not allowed for use in seafood, among
other foods, by the United States because they have been shown to have
a carcinogenic effect after prolonged exposure. However, some drugs
that remain unapproved by FDA, such as emamectin benzoate and oxolinic
acid, may be used in aquaculture by other countries. Another concern
associated with the use of drugs in animals used for food, including
seafood, is the extent of their contribution to antimicrobial
resistance.
Processing Facilities and Importer Inspections:
HACCP regulations require seafood processors to conduct a hazard
analysis and to develop and implement HACCP plans for hazards whenever
an analysis shows that one or more hazards are reasonably likely to
occur, including hazards resulting from drug residues. Processors must
verify that their HACCP plans are adequate to control the identified
significant hazards and are being effectively implemented. This
verification must include, at a minimum, a periodic reassessment of
the plan as well as ongoing verification activities, such as regular
testing of the product. Processors are responsible for addressing
hazards that may have been introduced into the products before they
reach the processors, which could include hazards resulting from drugs
unapproved by FDA for use in aquaculture. According to FDA documents,
the agency targets countries for inspection based on the volume of
imports from that country, the nature of the product (high-or low-risk
potential), and violation history, among other things. According to
FDA officials, the agency also targets facilities for inspection based
on, among other things, their history of violations and seafood
products refused entry into the United States. FDA has guidance that
provides instructions on the inspection of foreign seafood processing
facilities and products. From fiscal years 2005 through 2010, FDA
inspected, on average, 84 foreign processing facilities annually out
of an estimated 17,000 worldwide. (See appendix II for additional
information on the foreign facilities FDA inspected.)
In addition, FDA inspects importers of seafood products to ensure
their compliance with HACCP requirements. HACCP regulations require
importers to demonstrate, through documentation, that the seafood they
import into the United States complies with HACCP requirements. Under
HACCP, every importer of seafood products must either (1) obtain its
seafood products from foreign firms in countries that have an
agreement with FDA that documents the equivalency or compliance of the
foreign inspection system with the U.S. system for imported products
or (2) maintain written verification procedures that include product
specifications designed to ensure that the product is not adulterated
and take at least one of six affirmative steps to document that the
foreign firms supplying the seafood products comply with HACCP
requirements. We discuss the most commonly used affirmative steps
later in this report. According to FDA officials, the agency currently
has no such agreements with any foreign countries. FDA has guidance
that provides direction on the inspection of seafood importers. From
fiscal years 2005 through 2010, FDA inspected, on average, 217
importers annually out of about 3,900 importers registered with the
FDA.
FDA's Sampling Program:
In the United States, drugs used in animals that are used for food,
including seafood, generally must be approved by FDA. According to FDA
officials, the process for obtaining a new drug approval, including
drugs for aquaculture, originates with an entity or individual
(sponsor) submitting an application for review. FDA may approve a drug
for, among other things, specific species and certain disease
conditions. When FDA approves a drug, it may establish a maximum
residue level for the safe use of the drug--known as a tolerance
level. If residues of the approved drug are detected in an animal
product above the tolerance level, then the product is considered
noncompliant. FDA may take regulatory action when the residues are
confirmed at or above a drug tolerance level, which can vary by
species and residue. Likewise, if any residue of a drug unapproved by
FDA is detected, then the product is also considered noncompliant.
Similar to the United States, the EU and other countries also set
maximum residue limits for the drugs approved for use in aquaculture.
FDA has approved five different drugs for use in aquaculture that have
a maximum residue limit, but one approved drug (sulfamerazine) is no
longer marketed.[Footnote 7] In addition, FDA has approved two drugs--
formalin and hydrogen peroxide--for which it has not set a tolerance
level because the drugs are generally not absorbed into fish. FDA has
also approved tricaine methanesulfonate but has not set a tolerance
level because according to agency officials, this drug is approved for
research purposes only. In contrast, certain other countries and the
EU have approved more drugs, ranging from 7 to 32 (see fig. 2). Three
of the drugs FDA has approved have also been approved for use in
aquaculture by some of the countries listed in figure 2.
Figure 2: Drugs Approved for Aquaculture by Selected Countries and the
EU That Have a Maximum Residue Limit:
[Refer to PDF for image: vertical bar graph]
Country or entity: India;
Number of drugs: 4.
Country or entity: USA;
Number of drugs: 5.
Country or entity: Canada;
Number of drugs: 6.
Country or entity: Chile;
Number of drugs: 7.
Country or entity: Japan;
Number of drugs: 17.
Country or entity: China;
Number of drugs: 20.
Country or entity: EU;
Number of drugs: 31.
Country or entity: Vietnam;
Number of drugs: 32.
Source: GAO analysis based on data from various countries and the EU.
Note: Information on the number of drugs approved by the various
countries and entity are from reports with different dates.
[End of figure]
FDA has an import sampling program to guide its sampling of imported
seafood products for drug residues. FDA does not sample for the drugs
it has approved. According to FDA officials, its compliance program
guidance takes a risk-based approach to identify types of products to
sample, countries of interest, and specific drugs to look for. For
example, the current work plan for collecting samples of seafood
imports states that samples of shrimp products should be tested for
residues of nitrofurans. Additionally, every year FDA determines the
total number of import samples to collect for each product based on an
annual evaluation of the program's accomplishments and availability of
resources. When FDA detects a pattern of products in noncompliance--
when residues of drugs unapproved by FDA are present or approved drugs
exceed the tolerance levels--the agency can place the relevant firm
and product on import alert, which, among other things, places the
sampling and testing burden on the importer. On the basis of the
agency's compliance program guidance, FDA's sampling program has
targeted 16 drugs that may not be used in U.S. aquaculture, including
three antibiotic classes: fluoroquinolones (ciprofloxacin, difloxacin,
enrofloxacin, and sarafloxacin), nitrofurans (nitrofurantoin,
furazolidone, nitrofurazone, and furaltadone), and quinolones
(flumequine, nalidixic acid, and oxolinic acid); one antibiotic:
chloramphenicol; one antiparasitic: ivermectin; two antifungals:
gentian violet (also called crystal violet) and malachite green; and
one steroid: methyltestosterone. According to FDA officials, the
agency generally collects samples for drug residue testing at either
the domestic seafood processors or the ports of entry for imported
seafood products. Although there are numerous other drugs unapproved
for use in aquaculture in the United States, FDA targets these drugs
due to the potential human health consequences of consuming residues
of these drugs, which can cause cancer, allergic reactions, and
antibiotic resistance when consumed by humans, according to FDA. FDA's
sampling program emphasizes seafood products originating from
countries whose products have repeatedly been found to contain at
least one of these 16 drugs.
FDA can take several actions if it identifies HACCP violations or
adulterated seafood products. FDA may issue a warning letter--a notice
that enforcement actions may be forthcoming if corrections are not
made--to firms for serious violations of regulatory significance, such
as producing seafood products without a HACCP plan. FDA also may issue
import alerts, which are notifications to FDA staff that certain
products may be detained at the border without a physical examination.
Import alerts are designed to ensure that imported products covered by
the alert are detained and refused entry into the United States unless
the importer can overcome the appearance of the violation, such as by
providing FDA with the results of third-party laboratory analysis or
by passing an inspection that is appropriate to the violation that
demonstrates the imported product is safe and complies with all
applicable regulations. FDA currently has six seafood import alerts in
place: four related to the presence of drug residues and two
associated with HACCP violations. HACCP violations resulting in the
placement of a facility on an import alert may be related to drug
residue problems or other issues such as problems with sanitation
controls. According to FDA, the number of facilities and products
under import alerts changes as the facilities and products comply with
FDA regulations. (See appendix III for information on the six import
alerts as of March 2011.)
MOU between FDA and NMFS:
The Department of Commerce's NMFS also has a role in promoting seafood
safety and quality. Under the Federal Agricultural Marketing Act of
1946, as amended, NMFS' Seafood Inspection Program provides inspection
services on a fee-for-service basis to assist in marketing seafood
products. NMFS services include inspections for safety, wholesomeness,
and proper handling, as well as seafood grading, laboratory analysis,
training, and product inspection and certification. In 2010, NMFS had
contracts with 123 domestic processing facilities under its HACCP
Quality Management Program, which requires NMFS to provide, at a
minimum, quarterly HACCP-based inspections. NMFS also had contracts
with 37 foreign seafood processing facilities to provide HACCP
inspections. According to NMFS officials, it inspects about one-third
of all seafood consumed in the United States.
The 1974 MOU outlined actions for each agency regarding, among other
things, FDA's agreement to notify NMFS before taking regulatory action
and to conduct periodic joint meetings to develop collaboration
efforts. Despite the MOU, however, FDA did not take advantage of NMFS
inspection services or results to reduce its own inspection workload.
In particular, from fiscal years 2005 through 2009, we found that FDA
inspected 315 facilities that NMFS also inspected. In addition, in
2005, FDA considered taking legal action against NMFS officials
because FDA believed NMFS was interfering with its responsibilities,
according to senior NMFS officials. In the end, FDA did not pursue
this course of action. According to NMFS officials, as a result of
this incident, FDA and NMFS began negotiating an update of the 1974
MOU that was finalized in October 2009. According to NMFS officials,
since the signing of the 2009 MOU, there have been instances where
NOAA and FDA have worked closely together to address safety issues
that arose from the Gulf of Mexico oil spill as well as coordinate on
FDA regulatory actions.
FDA Food Safety Modernization Act:
Provisions included in the FDA Food Safety Modernization Act, enacted
in January 2011, may impact FDA's role in ensuring the safety of
seafood. For example, the act requires FDA to increase every year the
number of inspections of foreign food facilities. This may include
additional inspections of foreign seafood processing facilities. In
addition, the act includes provisions to encourage interagency
cooperation in regards to seafood inspections. This includes FDA
coordinating with the Secretary of Commerce on the inspections of
foreign seafood facilities and using Department of Commerce employees
to conduct inspections for FDA. The act's provisions also give FDA the
authority, as part of a third party accreditation program, to review a
foreign country's food safety programs, systems, and standards to
determine that the foreign government is capable of ensuring foods
certified for export to the United States meet the requirements of the
Federal Food, Drug, and Cosmetic Act. In addition, the act requires
the Secretary of Health and Human Services to issue guidance to assist
importers in developing a foreign supplier verification program to
help importers perform risk-based activities to verify that imported
goods comply with U.S. requirements. Facilities that are required to
comply with seafood HACCP regulations are exempt from the supplier
verification program. FDA also noted that the act gives the agency
important new tools, such as suspension of a facility's registration,
to ensure that imported seafood is as safe as domestic seafood (See
appendix IV, where the Department of Health and Human Services
provides details on these tools in its comments on our report.)
FDA's Program to Ensure the Safety of Imported Seafood from Residues
of Unapproved Drugs Is Limited, Especially as Compared with the EU:
FDA's program to ensure the safety of imported seafood from residues
of unapproved drugs is limited, because the agency's primary oversight
program generally involves reviews of documents at individual foreign
processing facilities and importers for HACCP compliance. In contrast,
the EU reviews foreign government structures, food safety legislation,
and the foreign country's fish farm inspection program to ensure
imported seafood products come from countries with seafood safety
systems equivalent to that of the EU. Moreover, FDA's sampling program
is limited in scope, is not effectively implemented, and does not
fully use the capabilities of FDA's laboratories.
FDA HACCP Inspections Are Limited When Compared to More Comprehensive
Reviews of Food Safety Systems Conducted by the EU and the Department
of Agriculture's FSIS:
FDA's program to ensure the safety of imported seafood against
unapproved drugs is generally limited to the HACCP regulations it
enforces. While the EU also requires compliance with HACCP, it also
takes a wide-ranging review of the food safety system of the foreign
country that wants to export its seafood products to the EU. In order
to export seafood to the United States, foreign processors must meet
the same HACCP regulations as domestic processors and FDA inspects
some foreign seafood processors each year to ensure compliance. These
inspections involve reviewing the processors' HACCP plans and other
records to ensure the processors have considered drug residues as a
hazard that is reasonably likely to occur if the seafood products it
receives are from fish farms. In general, as part of foreign HACCP
inspections, FDA inspectors do not visit fish farms to evaluate drug
use or controls. FDA inspectors also do not evaluate the capability,
competence, and quality controls of laboratories used to sample
seafood from fish farms to determine if they contain unapproved drugs
because these facilities are not considered processors under the
regulations and are therefore not covered by HACCP. We reviewed the 15
FDA inspection reports for seafood processing facilities from fiscal
years 2007 through 2009 from countries exporting seafood to the United
States--Bangladesh, Chile, China, and Thailand. According to the
reports, we found that during their visits to these processing
facilities, the inspectors generally conducted these inspections as
described above. In contrast, the EU includes inspection visits to
farms and other pertinent areas, such as laboratories, to undertake a
more comprehensive review of a foreign country's food safety system.
The EU conducts a review of the country's relevant legislation; the
government's structure for implementing it; and the country's
implementation of its national residues monitoring plan, which the EU
directs its trading partners to submit. Foreign countries that trade
with the EU are directed to implement the monitoring plan and sample
for drugs of specific concern to the EU. Once implemented, these
foreign countries are to provide an annual report on the sampling
results.[Footnote 8] In addition, the EU also reviews a sample of
farms and processing facilities, and the capabilities and quality of
the country's laboratories. The EU also requires that foreign
countries exporting seafood to the EU maintain seafood safety systems
that meet EU requirements or equivalent conditions, or meet specific
requirements provided in an agreement between the EU and the foreign
country.
In addition to FDA's HACCP inspections, the agency conducts foreign
country assessments to gather information about other countries'
aquaculture programs including the country's competent authority and
regulatory infrastructure. During these assessments, FDA officials
visited some farms where aquaculture products originated to evaluate
veterinary drug use and reviewed some laboratories that analyzed the
seafood products for drug residues for processors, among other places.
FDA officials stated that these visits are planned and tailored for
each country and conducted in a systematic and consistent manner. The
information the agency collects during these assessments results in a
written report and can be used to direct future foreign facility HACCP
inspections and FDA's sampling program for imported seafood. However,
according to FDA officials, the agency does not have any written
operating procedures or any criteria or standards that it uses for
these assessments to evaluate a country's regulatory infrastructure;
farms; or the capabilities, competence, and quality controls of
foreign laboratories. Without policies and procedures or guidance to
direct the implementation of these assessments and criteria or
standards to evaluate foreign systems, it may be difficult for FDA to
conduct foreign country assessments that are either systematic or
consistent and that result in valid findings. By systematically and
consistently conducting its foreign country assessments, FDA can
better assure that it is using its resources effectively and
efficiently. FDA has conducted such foreign country assessments in
five countries: Chile, China, India, Indonesia, and Vietnam. FDA
conducted its first foreign country assessment in April 2006 and
according to FDA officials, each assessment cost about $45,000. About
a week after our closing meeting, FDA provided us with newly prepared
standard operating procedures for conducting its foreign country
assessments. FDA prepared these procedures almost 5 years after
conducting its first assessment in Vietnam. These new procedures
include the purpose of the assessments, country selection process,
provisions on conducting these assessments, and structure of the
assessment reports, among other things. We did not evaluate the newly
prepared procedures. Still, FDA has not documented (1) the assessments
on its Web site, including any program guidance manuals, and (2) the
link between these assessments and its HACCP inspections of foreign
facilities or its imported seafood sampling program.
The following are examples of some of the limitations of FDA's
oversight approach of reviewing records and other documentation of
foreign processors as required by HACCP and limited effectiveness of
its foreign country assessments.
* As described in FDA's inspection reports for three Chilean salmon
processing facilities in 2008, FDA's review of their records during
the inspectors' visits to these facilities revealed that, contrary to
HACCP regulations, they had received fish farm products that had been
treated with oxolinic acid, flumequine, or emamectin benzoate--drugs
unapproved for use in aquaculture in the United States. According to
FDA documents, the agency placed all three facilities on an import
alert for failing to comply with HACCP. FDA removed one of these
facilities from the import alert 14 days later and the other two
facilities several weeks later after they made changes to their
respective HACCP plans. FDA, however, could not provide documents
detailing the changes these facilities made in order for FDA to remove
them from the import alert. Two of the facilities then shipped salmon
to the United States, where it was accepted for import. While this
approach is in concert with FDA's routine inspection process, FDA had
no assurance that the changes the facilities made to their HACCP plans
were implemented, since it did not reinspect the facilities to conduct
follow-up reviews of their records. In March and April of 2009, FDA
officials conducting a foreign country assessment visited Chile to
gather information about Chile's measures to control drug residues in
aquaculture seafood products it exported to the United States. These
officials found that the same unapproved drugs were still in use in
the country. According to these officials, Chilean officials told them
that the Chilean government could not prohibit the export of products
containing residues of drugs approved for use in Chile without a
special agreement with the importing country. According to FDA
officials, the agency has not taken steps to develop such an
agreement. Chile represents about 4 percent of seafood imported into
the United States and in 2009, it was the largest source of farmed
salmon imports into the United States.
* In addition to the 15 inspection reports, FDA documented the results
of its officials' visit, part of a foreign country assessment, in
September 2008 to Vietnam to gather information about the country's
drug residues control program. The documentation indicated that all
processing facilities' HACCP plans stated if a drug unapproved by the
EU is found in a seafood product, that product should be diverted to
another market. The FDA officials concluded that this HACCP plan
requirement could result in such products being imported into the
United States. In addition, the documentation indicates these FDA
officials found that Vietnam permitted 38 drugs, most of which are
unapproved by the United States, to be used in aquaculture. For
example, FDA's documentation on this visit stated that fish farms were
likely using fluoroquinolones. FDA officials asked that the Vietnamese
government notify processors that seafood products purchased from
farms using this drug could not be exported to the United States. FDA
also asked the government to test 100 percent of seafood products
destined for the United States for unapproved drugs such as
nitrofurans and chloramphenicol. The Vietnamese government responded
that it performed 100 percent testing only for products intended for
countries with which it had a bilateral agreement, of which the United
States was not one. The government stated, however, that it was taking
other actions that would preclude the need for this level of testing,
such as disseminating information on unapproved drugs, providing
training to local authorities, and disciplining violators. According
to FDA officials, the agency has not taken steps to develop such an
agreement. Vietnam represents about 5 percent of the seafood imported
into the United States. In 2009, Vietnam was the largest source of
farmed catfish-pangasius imports and the third largest source of
farmed shrimp imports into the United States.
In addition to foreign processors, FDA also inspects the records of
importers that bring seafood products into the United States to make
sure they follow HACCP regulations, which includes requirements that
importers maintain documents showing that the imported products are
from foreign suppliers that have themselves complied with HACCP
regulations or that the product is obtained from a country with an
active agreement with FDA covering the product that documents
equivalence or compliance with the U.S. system. We found limitations
with this aspect of FDA's program as well. According to FDA officials,
importers most frequently comply with this regulation in one of the
three following ways:
* Importers obtain a copy of a foreign processor's HACCP plan and an
attestation that the foreign firm processes its seafood products in
compliance with HACCP regulations. Importers review the HACCP plan
they get from their foreign suppliers and determine if all of the
hazards the importers identified in their specifications are
controlled in the HACCP plan. However, according to a senior FDA
official, foreign processors can obtain a HACCP plan that is not
associated with its own operation, thus defeating the purpose of
importers' acquiring a copy of the plan unless the importers also
visit the foreign processor to validate the information in the plan
and that it is being implemented. FDA does not require importers to
visit the foreign processors to ensure they effectively implement
their HACCP plans.
* Importers obtain inspection certificates from what FDA calls a
"competent authority," such as the Canadian Food Inspection Agency,
that attests to the safety of the seafood product. However, FDA has
not made any formal judgments about any entity's capability to declare
that any foreign seafood products meet U.S. safety standards or
concluded any agreements on a foreign certification program.
* Importers obtain seafood products from Canada or Japan from firms
that those governments stated both are in "good standing" and are
listed on an FDA Web site as processing seafood in accordance with
HACCP regulations. However, FDA has neither evaluated the Canadian or
Japanese seafood safety systems to determine the extent to which these
countries' systems meet U.S. standards nor verified the lists or the
information on them. For example, FDA has inspected for HACCP
compliance, 4 Canadian and 22 Japanese seafood processing facilities
out of an estimated total of 944 and 2,697 facilities in each country,
respectively, from fiscal years 2005 through 2010.
The EU not only requires individual processors to meet HACCP
requirements, but also requires the foreign countries that want to
export farmed seafood to the EU to demonstrate that their seafood
safety systems meet EU or equivalent requirements, or meet
requirements specified in an agreement between the EU and the
exporting country. The EU Web site provides information for foreign
countries on the EU standards for food products, including seafood,
destined for the EU. These standards are used to evaluate foreign food
safety systems. The EU publishes its foreign country inspection
reports on its Web site, along with the foreign country's comments and
their plan to address the inspection report's recommendations. To
ensure continuous compliance with EU requirements, EU inspectors
periodically conduct follow-up reviews of foreign countries' seafood
safety systems. If inspectors identify deficiencies, they recommend
solutions and ask the government in question to develop an action plan
to address the recommendations. Using this approach, the EU has been
able to persuade foreign governments to take appropriate action to
address recommendations. For example:
* The EU inspected Indonesia in November 2009 to evaluate, in part,
the country's measures to control drug residues in animal products
including seafood. The inspectors concluded that the effectiveness of
the system to control drug residues was compromised by failings in the
planning and implementation of Indonesia's national residue control
plan and problems in laboratory performance, including questionable
validation of methods to detect drug residues in aquaculture products.
According to the EU inspectors, the system to control drug residues
did not provide guarantees equal to those required by EU regulations.
The EU inspectors made specific recommendations to resolve the
problems, including aligning the Indonesian limits for drug residues
with those of the EU and ensuring that government controls on the
distribution and use of veterinary medicinal products were carried out
throughout the distribution chain. The Indonesian government developed
an action plan to address all the recommendations. Nevertheless, as a
result of the inspection report findings, the EU imposed a 20 percent
sampling requirement at the EU ports of entry for all farmed fish
imports because it believed that there was a risk that imported farmed
products from Indonesia contained residues of chloramphenicol,
nitrofurans, and tetracyclines.
* In November 2008, the EU inspected Bangladesh, in part, to evaluate
the country's programs to control drug residues in seafood and review
the implementation of corrective actions promised by the Bangladesh
government to address previous EU recommendations. EU inspectors found
that Bangladesh was making changes to its sampling and laboratory
analysis, among other things. Nevertheless, the inspectors concluded
that despite the steps taken by the Bangladesh government to eliminate
all sources of nitrofurans and chloramphenicol from farmed fish, the
high detection rate of these drugs identified by Bangladesh's own
national monitoring program suggested that fish farms were still using
these drugs. According to the EU inspectors, the Bangladesh system to
control residues did not provide assurances equal to those required by
EU regulations, among other things. In part because of the findings of
this inspection, the Bangladesh government imposed a voluntary ban on
the export of freshwater shrimp to the EU from May 2009 until January
2010. The Bangladesh government recognized that it had a problem with
nitrofurans in freshwater shrimp and took this action to avert any
potential ban by the EU. The EU placed Bangladesh on special import
conditions in 2008, which required 100 percent testing of all shrimp
bound for the EU for chloramphenicol, tetracycline, nitrofurans,
malachite green, and crystal violet in Bangladesh prior to export. In
addition, 20 percent of all shrimp imports must also be tested at EU
ports of entry at the importers' expense.
In contrast, FDA inspected five Bangladesh seafood processing
facilities in February 2009, and a review of the inspection reports
indicated that FDA inspectors did not identify the continued use of
nitrofurans and chloramphenicol by the fish farms. Because FDA's focus
was on HACCP compliance--which required the review of documents to
ensure consideration was given to whether potential hazards were
reasonably likely to occur as a result of drug residues, among other
things--rather than the review of elements of the Bangladesh seafood
safety system, FDA was unable to identify this issue. Although the
Bangladesh government considered the EU findings from 2008 significant
enough to impose a ban of shipments of freshwater shrimp to the EU
about 3 months after the FDA inspections, Bangladesh officials present
at FDA's inspections did not provide information on the EU findings of
the continued use of unapproved drugs by fish farms to FDA. Moreover,
Bangladesh did not impose a similar ban on shipments to the United
States, and according to FDA officials, the agency, at the time, had
no knowledge of the Bangladesh ban on shipments to the EU.[Footnote 9]
Had the FDA inspectors had this information, they could have more
effectively scrutinized the methods processors used to ensure the
safety of the seafood products they received from fish farms. FDA
inspectors could have also discussed Bangladesh government efforts to
eradicate the use of unapproved drugs by the fish farms. With
information on the use of nitrofurans by Bangladesh shrimp farms, FDA
inspectors could have helped direct FDA's import sampling program to
target these products. Because it lacked this information, FDA did not
adjust its sampling program to take into account the likelihood that
shrimp exports from Bangladesh would be contaminated. In fact, from
June through December 2009--the period of the ban--FDA analyzed four
shrimp samples from Bangladesh for nitrofurans. Finally, equipped with
this information, the United States could have potentially received
similar consideration as was given to the EU in regards to the ban by
the Bangladesh government.
Like the EU, the Department of Agriculture's FSIS regulations place
greater responsibility on the foreign country that wants to export
meat, poultry, or processed egg products to the United States. More
specifically, imported meat, poultry, and processed egg products are
not eligible for export to the United States unless FSIS has
determined that the exporting country has a food safety system
equivalent to that of the United States. The FSIS Web site provides
information on its equivalence process and on the standard for
eligibility of foreign countries to export FSIS regulated products to
the United States. FSIS audit reports also provide information on the
criteria used for its audits. In addition, FSIS publishes its foreign
country audit reports on its Web site. FSIS staff not only review
documents provided by foreign governments to ensure their food safety
regulations and oversight are adequate and that processors implement
HACCP, among other things, but also conduct onsite evaluations of the
governments' inspections of slaughter processing facilities and their
audits of laboratories and controls over, among other things, drug
residues, sanitation, and animal disease of public health concern. In
addition to the reviews and onsite evaluations, FSIS also conducts
drug residue sampling, microbiological sampling, and labeling
verification, among other things, at U.S. ports of entry to promote
compliance. FSIS' program and the requirements it places on foreign
governments wishing to export food products to the United States may
have an effect on how countries react to problems that FSIS identifies
with their products.
The potential effect that the FSIS' oversight approach can have on the
food safety actions of other countries can be illustrated in the
situation that occurred with Brazilian beef. In May 2010, as part of
FSIS' port-of-entry inspection program, the agency analyzed samples of
cooked beef products from a Brazilian plant and identified levels of
ivermectin, an antiparasitic agent, above allowed limits. FSIS
increased its testing of cooked beef products from this plant and
continued to find drug residue problems. Consequently, FSIS refused
entry of cooked beef products into the United States from this plant
and expanded its sampling effort to include Brazilian cooked beef
products already in commerce and cooked beef products from other
Brazilian plants. The testing data indicated that cooked beef products
from other Brazilian plants also had levels of ivermectin above
allowed limits. Given the consistency of the data, FSIS concluded that
the Brazilian government's oversight program--including its residue
sampling and control programs--had broken down. The U.S. government
communicated its findings to the Brazilian government and asked that
it resolve this violation of U.S. regulations. Although FSIS had the
authority to deny entry into the United States of the products of all
of these Brazilian plants if this issue had not been resolved
appropriately, the Brazilian government voluntarily stopped exporting
cooked beef products from 24 plants and prepared and submitted a plan
to FSIS for how it intended to address this issue. According to FSIS,
on December 28, 2010, FSIS accepted Brazil's corrective action plan,
resulting in Brazil removing its voluntary suspension to allow 12 of
the 24 plants to export cooked beef products to the United States. In
addition, to verify that Brazil's corrective actions are adequate and
effective in preventing a recurrence of this situation, FSIS will
request Brazil to provide documentation demonstrating that its residue
plan is working.
FDA's Sampling Program Is Limited in Scope, Not Effectively
Implemented, and Does Not Fully Use Its Laboratories' Capabilities:
FDA's sampling program for detecting residues from unapproved drugs in
imported seafood products is limited in scope. Although FDA tests for
residues of 16 unapproved drugs, some other countries importing from
the same countries as the United States test for up to 57 drugs. In
addition, although the 16 drugs include drugs such as flumequine and
oxolinic acid, which are approved in certain other countries, FDA is
not testing for residues of other drugs, such as emamectin benzoate or
tetracycline, that are approved in other countries but unapproved in
the United States. Thus, FDA does not generally test for drugs that
some countries and the EU have approved for use in aquaculture.
Because these drugs may be used in countries with which the United
States conducts considerable trade, seafood products containing these
unapproved drugs may be entering the country. For example, China, a
major seafood exporter to the United States, approves the use of
tetracycline in aquaculture although the United States does not.
Vietnam, also a major seafood exporter to the United States, approves
the use of neomycin in aquaculture but the United States does not.
Both tetracycline and neomycin have been determined to be highly
important antimicrobials in humans; according to the World Health
Organization, however, the overuse of these drugs in food animals
could contribute to increasing the risk of antibiotic resistant
bacterial infections in humans. In 2007, Japan detected excessive
levels of tetracycline residues in the shrimp products it imported
from China and in 2010, the EU detected excessive levels of neomycin
in imported catfish from Vietnam. Because FDA does not include
tetracycline and neomycin in its sampling program, it has no assurance
that seafood containing these drug residues has not entered the United
States.
In addition, FDA does not effectively implement its limited sampling
program. According to FDA officials, the equipment and personnel the
agency dedicates to its sampling program are sufficient to complete
its assignment plan in its entirety. However, FDA did not meet the
performance goals it set for its targeted unapproved drugs for fiscal
years 2006 through 2009: the agency planned to collect on average 975
import samples annually for testing but collected an average of about
680 samples (or about 70 percent). According to FDA officials, the
agency may not achieve its goals because a specific seafood product
may not come into the country as anticipated or there may be a need to
shift laboratory resources to handle other urgent tasks, such as
testing imported honey for chloramphenicol. Moreover, FDA's planned
number of import samples to collect represents a small portion of the
annual seafood imports into the United States. Thus, in fiscal year
2009, the seafood samples FDA reported it collected for drug residue
testing amounted to 0.1 percent of all the seafood products imported
into the United States. In addition, although FDA's import sampling
program states that it prioritizes the testing of all shrimp and all
catfish and catfish-related species for residues of nitrofurans,
during fiscal years 2006 through 2009 FDA analyzed 279 shrimp samples
out of the 1,060 shrimp samples collected for residues of nitrofurans
and did not analyze any catfish samples for nitrofurans. In fiscal
year 2008, according to its annual work plan, FDA planned to collect
125 shrimp samples for nitrofurans analysis. Although FDA collected a
total of 349 shrimp samples, it tested only 34 for residues of
nitrofurans, and 6 (18 percent) of these samples were found to contain
nitrofurans. Because of FDA's limited sampling, some of the more than
2.5 million metric tons of shrimp and 156,000 metric tons of catfish
imports that entered the United States during fiscal years 2006
through 2009 could have contained residues of nitrofurans.
In addition to the limitations of FDA's sampling program for drug
residues, the agency does not effectively use its laboratory
resources. For example, while some other countries have increased
their laboratory capabilities through programs to accredit commercial
laboratories, FDA relies on 7 of its 13 laboratories to conduct all of
its aquaculture drug residue testing.[Footnote 10] According to FDA
officials, the number of laboratories participating in the sampling
program is not important because sufficient laboratory capacity and
capabilities are developed to meet obligations. However, as discussed
above, FDA has not met its sampling performance goals during the past
years and the number of laboratories participating in the sampling
program may play a part in this. In terms of the laboratories that FDA
uses for its sampling program, not all seven have the capability to
test for all of the drugs included in FDA's sampling program. For
example, one laboratory is capable of testing for residues of
chloramphenicol, and four laboratories are capable of testing for
nitrofurans, three of which have the capability to test for malachite
green, gentian violet, fluoroquinolones, and quinolones. Further, FDA
lacks some of the analytical methods that its laboratories need to
test for specific drugs in aquaculture. For example, FDA has no method
to detect residues of emamectin benzoate, a drug unapproved for use in
U.S. aquaculture but used in Chile, as noted above, and approved for
use in other countries as well. Moreover, although FDA can test for
nitrofurans in four of its laboratories, it has only one method for
testing nitrofurans in catfish samples.[Footnote 11] FDA's laboratory
capabilities are also limited by the personnel available to perform
the tests. Although FDA has assigned personnel to its sampling
program, these resources can be shared across FDA's food programs.
Consequently, FDA can divert personnel to other programs that it may
consider higher priority when the need arises, which could result in a
lag in the turnaround time for drug residue testing. For example,
according to FDA officials, FDA allows 14 calendar days to test a
sample for drug residues. In addition, time frames for the completion
of analyses under the sampling program will vary by residue and
species. We found that the average time between sample collection and
testing was about 22 calendar days. In one instance, testing for one
sample was completed 154 calendar days after it was collected; in
another instance, FDA took 56 days to complete the analysis of two
separate samples--both of which turned out to contain residues of
unapproved drugs.
In contrast with FDA's import sampling program, the sampling programs
of Canada, the EU, and Japan test for significantly more drugs: Canada
tests its imported seafood products for more than 40 different drugs,
select EU member countries test for 50 drugs, and Japan tests for 57.
In addition, Canada and Japan test for levels of drugs they have
approved for use in aquaculture as well as for drugs that are
unapproved in their own country but approved in other countries.
Moreover, Canada, the EU, and Japan generally test more samples of
seafood and have more extensive laboratory capabilities than FDA. For
example, Canada routinely tests at least 5 percent of all seafood
imports, and Japan tested about 11 percent of seafood imports in
fiscal year 2009. Select EU member countries test for as much as 4
percent of their seafood imports. In addition, the EU requires more
testing for countries that produce larger quantities of seafood
because of the increased risk of more adulterated products. Further,
unlike FDA, which relies only on its own laboratory capabilities,
Canada, the EU, and Japan have systems in place to accredit commercial
laboratories which may be involved in the testing for drug residues in
seafood products. For example, Belgium has 8 national laboratories as
well as a network of 62 EU member state and commercial laboratories to
assist with drug residue testing.
FDA and NMFS Have Made Limited Progress to Implement the 2009 MOU, and
FDA Has Not Leveraged NMFS Inspection Resources:
FDA and NMFS have made limited progress in implementing the 2009 MOU,
resulting in a lack of systematic collaboration between the agencies.
Since March 2010, the agencies have collaborated to some extent in
developing procedures for certain MOU responsibilities, specifically
FDA notification of regulatory action. In addition, while FDA and NMFS
effectively collaborated and successfully leveraged each others'
resources during the 2010 emergency Gulf of Mexico oil spill, FDA has
not yet fully met its MOU responsibility to utilize NMFS' foreign and
domestic inspection resources in a systematic manner. NMFS Seafood
Inspection Program describes its mission as ensuring the safety and
quality of the seafood it inspects. FDA officials stated that training
NMFS inspectors would bring them to a level commensurate with the
level that FDA requires of its own inspectors. By effectively
utilizing NMFS inspections resources to help minimize its own
inspection responsibilities, FDA could inspect other facilities that
have not yet been inspected.
FDA and NMFS Have Made Limited Progress in Implementing Specific MOU
Responsibilities:
During a meeting to discuss the MOU in March 2010, the agencies agreed
to create standard operating procedures for certain MOU
responsibilities. FDA officials told us that in September 2010 they
sent NMFS a letter notifying them of an FDA regulatory action, which
is one of the MOU responsibilities. According to NMFS officials, this
letter was the first prior notification of regulatory action FDA had
ever provided. NMFS officials added that communication between the
agencies has consisted of periodic conference calls that included
discussions of the oil spill. Frequent communication among
collaborating agencies is a means to facilitate working across agency
boundaries and prevent misunderstanding; without such communication,
enhanced collaboration may not be sustained.[Footnote 12] According to
NMFS officials, NMFS has developed guidance for its staff regarding
its 2009 MOU responsibilities. Similarly, according to FDA officials,
the agency has developed some guidance like the notification letter
template. However, the agencies have not developed guidance for items
of mutual responsibility. As we previously reported, agencies need to
address the compatibility of standards, policies, and procedures in
order to facilitate collaboration.[Footnote 13] The agencies have
agreed to develop standard operating procedures for information
sharing and cross training of personnel, but they have not yet done so.
Success in Leveraging Resources for the Gulf of Mexico Oil Spill Has
Not Translated to FDA Leveraging NMFS Inspection Resources or Results
in a Systematic Manner:
Even with FDA's and NMFS' success in leveraging each other's resources
in the 2010 Gulf of Mexico oil spill, FDA has yet to fully meet its
responsibility under the MOU to utilize NMFS inspection resources or
results in a systematic manner. While NMFS describes its mission as
ensuring the safety and quality of the seafood it inspects, FDA
officials stated that training NMFS inspectors would bring them to a
level commensurate with the level that FDA requires of its own
inspectors.
The leveraging of resources played a crucial role in FDA and NMFS'
ability to address the effects of the Gulf of Mexico oil spill. Using
guidance developed from previous oil spills, the agencies quickly and
jointly developed a protocol to reopen oil-impacted areas closed to
seafood harvesting. The emergency nature of the spill meant that
implementing the protocol required timely collaboration between FDA
and NMFS. The agencies successfully implemented their reopening
protocol by, among other things, sharing staff and laboratory
resources and cooperating efficiently. In accordance with the
reopening protocol, the agencies jointly organized the seafood
sampling plan and agreed upon the use of NMFS' sensory testing
protocol following FDA review. The agencies successfully coordinated
the chemical testing of samples for oil residue among their respective
laboratories. As agreed upon in their reopening protocol, both
agencies reviewed all sample results and consulted with each other
before NMFS communicated the results to the states.
Going forward, FDA has not developed a process to leverage NMFS'
domestic and foreign inspections or results in order to maximize its
limited resources and inspect other facilities that have not yet been
inspected. Both the 1974 and 2009 MOUs address the leveraging of NMFS'
inspections by FDA in order to maximize the use of available
resources. As we stated in our October 2005 report, collaborating
agencies bring different levels of resources and capacities to the
collaborative effort and can leverage each others' resources to obtain
additional benefits that would not be available if they were working
separately.[Footnote 14] FDA's inspection work plan does not consider
establishments under contract with NMFS in determining the facilities
FDA plans to inspect in any given year. In addition, by not
effectively utilizing NMFS inspection resources or results, FDA has
allowed some processing facilities to go without an inspection. A 2010
audit by the Department of Health and Human Services' Office of
Inspector General found that 56 percent of domestic food facilities
had gone 5 years or more without an FDA inspection. The audit report
pointed out that FDA cannot ensure that these facilities are complying
with applicable laws and regulations if it does not routinely inspect
them.[Footnote 15] The need to leverage NMFS inspection resources or
results was especially critical in China, which accounts for 23
percent of seafood imports into the United States. FDA has inspected
41 of 2,744 (or 1.5 percent) Chinese seafood processing facilities in
the last 6 years.
FDA officials provided new information during our closing meeting
concerning the agency's plans to use NMFS inspections results.
According to these officials, the agency needs to first increase the
level of training of NMFS inspectors. Towards that goal, FDA has begun
to train NMFS inspectors using an advanced FDA course to increase the
inspection capabilities of NMFS inspectors to a level commensurate
with the level that FDA requires of its own inspectors. For example,
FDA plans to train at least 16 NMFS inspectors during fiscal year
2011. NMFS officials confirmed that NMFS inspectors are attending
FDA's training in order to meet FDA's training requirement and advance
the MOU's provision of leveraging resources. In addition, these NMFS
inspectors who completed the training and took the FDA exam, passed.
However, according to NMFS officials, NMFS training and its
inspectors' capabilities are already equivalent to those of FDA
inspectors. According to FDA officials, once NMFS inspectors are
trained, the agency plans to inspect some Chinese seafood processing
facilities jointly with NMFS to evaluate the NMFS inspectors'
capabilities. FDA officials also noted that once NMFS inspection
capabilities reach FDA's required level, the agency will consider
using NMFS inspection results as another source of information that
will feed into FDA's risk analysis process for determining the
facilities to inspect in any given year. However, FDA has yet to fully
develop this risk approach and no time frames or documentation exists
for its full development. FDA noted that the use of NMFS inspection
results would be part of FDA's implementation of any third-party
certification program, which is mandated by the FDA Food Safety
Modernization Act. Therefore, at this point, FDA has not documented
how it plans to use NMFS inspection results.
FDA has previously provided other reasons for not using NMFS
inspection resources or results. In 2005, we recommended that FDA
recognize the results of NMFS inspections when the agency determined
the frequency of its seafood inspections. In response, FDA stated that
it would assess this issue. However, FDA officials also stated that
the agency did not rely on NMFS's inspection information because NMFS
could have conflicts of interest due to its fee-for-service inspection
approach and because FDA did not know what facilities NMFS was
inspecting.[Footnote 16] A year earlier, we recommended that FDA and
NMFS develop a MOU so that FDA, in part, would use and leverage NMFS
inspection services to more efficiently and effectively monitor the
safety of imported seafood. In response, FDA stated that it would
explore additional opportunities to better leverage NMFS inspection
resources and more efficiently and effectively protect the public
health. We also noted that an FDA official raised concerns about
potential conflicts of interest with NMFS inspections, but that other
officials thought that these concerns could be addressed in an
agreement.[Footnote 17]
Conclusions:
With about a 20 percent increase in the consumption of imported
seafood in the last 10 years, FDA's responsibility has also increased
for ensuring the safety of the nation's food supply, including
imported seafood. However, FDA still uses the same approach it
developed more than 10 years ago to ensure the safety of imported
seafood, even though the United States' reliance on imported seafood
has increased and aquaculture has emerged as a major source of those
imports. FDA's approach is generally focused on reviewing records of
foreign processors and importers and does not consider other pertinent
areas of a foreign country's food safety system. Its foreign country
assessments have been limited by the lack of formal structure and
necessary policies, guidance, and criteria. In addition, FDA's
sampling program does not give appropriate consideration to testing
for the drugs approved for use in aquaculture by major U.S. seafood
trading partners but unapproved by the United States and does not
effectively use its laboratory resources. There are practices employed
by other entities with similar regulatory responsibilities as FDA,
including another U.S. government agency, which show potentially more
effective alternatives to the current FDA approach. The recently
enacted food safety legislation provides FDA with new authorities that
may enable it to more comprehensively review a foreign country's
seafood safety system and implement the practices that other entities
employ to ensure the safety of imported food products. For example,
the EU requires foreign countries with which it trades to maintain
seafood safety systems that meet EU requirements or equivalent
conditions, or meet specific requirements provided in an agreement
between the EU and the foreign country before the EU will accept
seafood imports from that country. Also, the EU specifically directs
that the foreign country submit a national residues monitoring plan,
which provides information on the sampling for drugs of concern to the
EU for seafood products destined to the EU. That monitoring plan must
have an effect at least equivalent to those required within the EU. To
facilitate consideration and implementation of a different oversight
approach to ensure the safety of imported seafood, FDA must utilize
its current resources in the most efficient manner. However, FDA is
not efficiently using its resources when it does not effectively
implement the 2009 MOU with NMFS and fully utilize the resources of
NMFS' Seafood Inspection Program, an agency dedicated specifically and
solely to ensuring the quality and safety of seafood. According to FDA
officials, training NMFS inspectors would bring their capabilities to
a level commensurate with FDA requirements. Furthermore, although FDA
worked effectively with NMFS in ensuring the safety of domestic
seafood during the Gulf of Mexico oil spill, it lacks systematic
collaboration with that agency. Provisions in the new food safety
legislation also provide FDA with more specific direction and
opportunity for greater collaboration with NMFS through, in part, more
effective use of its inspection resources or results.
Recommendations for Executive Action:
To better ensure the safety of seafood imports, we recommend that the
Secretary of Health and Human Services direct the Commissioner of FDA
to take the following three actions:
* study the feasibility of adopting other practices used by other
entities, such as requiring foreign countries that want to export
seafood to the United States to develop a national residues monitoring
plan to control the use of aquaculture drugs, to more efficiently
ensure the safety of imported seafood and report its findings to the
Secretary;
* develop a more comprehensive import sampling program for seafood by
more effectively using its laboratory resources and taking into
account the imported seafood sampling programs of other entities and
countries; and:
* develop a strategic approach with specific time frames for enhancing
collaborative efforts with NMFS and better leveraging NMFS inspection
resources.
Agency Comments and Our Evaluation:
We provided the Departments of Agriculture, Commerce, and Health and
Human Services (HHS) a draft of this report for their review and
comment. We also provided a draft of this report as a courtesy to the
Department of Homeland Security, the Department of State, and the
Office of the United States Trade Representative. On March 23, 2011,
we received written comments from HHS, which are reproduced in
appendix IV; HHS neither agreed nor disagreed with the findings and
recommendations in the report. The Departments of Agriculture and
Commerce did not provide written comments.
HHS notes that our report represents a baseline against which FDA can
measure its ongoing progress. The department also states, however,
that reading our report may not result in a full understanding of
FDA's multifaceted and risk-informed seafood safety program that
relies on information from various sources and provided additional
information in this regard. (See app. IV for our response to this and
other general comments.) In addition, while HHS did not explicitly
agree or disagree with our recommendations, the department provided
information in its written comments on actions in process or planned
related to each of the recommendations we made in our draft report.
The additional information related to each of our three
recommendations follows:
* Study the feasibility of adopting other practices used by other
entities, such as requiring foreign countries that want to export
seafood to the United States to develop a national residues monitoring
plan to control the use of aquaculture drugs, to more efficiently
ensure the safety of imported seafood and report its findings to the
Secretary: HHS stated that as part of implementing the Food Safety
Modernization Act, FDA will determine whether the legislation supports
the kind of precondition for export to the United States that the FDA
stated our recommendation envisioned.
* Develop a more comprehensive import sampling program for seafood by
more effectively using its laboratory resources and taking into
account the imported seafood sampling programs of other entities and
countries: HHS stated that FDA agrees that effective use of laboratory
resources and import sampling programs are important facets of a
comprehensive and risk-informed program to ensure seafood safety. HHS
stated that FDA is evaluating proposed research to further expand
residue and species coverage and identify areas for improved
laboratory testing efficiencies.
* Develop a strategic approach with specific time frames for enhancing
collaborative efforts with NMFS and better leveraging NMFS inspection
resources: HHS stated that FDA agrees that it is important for the
agency to maintain and foster this collaborative and effective working
relationship with NMFS. Further, FDA will work with NMFS to develop
strategic approaches for enhancing collaboration and better leveraging
seafood inspection resources. However, the agency did not comment on
its intent to establish specific time frames for this enhanced
collaboration, which we believe remains essential to help ensure
accountability for and expeditious implementation of this strategic
approach.
HHS and the Department of Commerce also provided technical comments,
which we incorporated as appropriate.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to the
appropriate congressional committees; the Secretaries of Health and
Human Services, Agriculture, Commerce, Homeland Security, and State;
the United States Trade Representative; and other interested parties.
In addition, the report will be available at no charge on the GAO Web
site at [hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. Key contributors to this report are
listed in appendix V.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Scope and Methodology:
The Department of Health and Human Services' Food and Drug
Administration (FDA) has responsibility for ensuring the safety of
seafood imports. The Department of Commerce's National Marine
Fisheries Service (NMFS) provides voluntary fee-for-service
inspections to ensure compliance with FDA's Hazard Analysis and
Critical Control Point (HACCP) regulations, among other things. To
assess the extent to which FDA ensures the safety of seafood imports
against residues from unapproved drugs, we analyzed information on
FDA's oversight mechanism for seafood imports--importer and foreign
country processing facilities inspections--and its seafood import
sampling program. In particular, we analyzed information on the major
components and requirements of FDA's importer and foreign facility
HACCP inspections. Specifically, we reviewed FDA's inspection reports
for seafood processing facilities from major seafood exporting
countries to the United States--Bangladesh, Chile, China, and
Thailand--and focused our review on 15 FDA inspection reports for
facilities that processed aquaculture seafood products during fiscal
years 2007 through 2009. We analyzed fiscal years 2006 through 2009
data on FDA's import sampling program's test results to determine the
magnitude and scope of the program. As part of our data request, we
asked FDA to provide the drug residue being tested for in each
analysis. However, information on drug residue, country of origin, and
type of seafood was in data fields combined with other information and
not easily analyzable. Consequently, we used a statistical program
searching for key words to analyze the data. After this preliminary
identification of the drug being analyzed, country, and seafood type,
we independently verified that the information was correct. In
addition, we conducted several data checks, including reviewing the
data for missing or incomplete information and testing for obvious
errors in accuracy and completeness, to ensure the reliability of the
data. Furthermore, we interviewed knowledgeable FDA officials to
discuss the database's internal controls and other measures used to
ensure the reliability of the data. We determined that the data were
sufficiently reliable for our purposes.
We reviewed documents regarding the seafood importing programs of the
European Union (EU), the largest importer of seafood worldwide; Japan,
the second largest importer of seafood worldwide; and Canada, a major
provider of seafood to the United States. We reviewed the EU's
importing program to determine if its practices for ensuring the
safety of seafood imports have the potential for enhancing our own
practices. As part of this effort, we reviewed the EU's inspection
reports of select foreign countries that are the major providers of
seafood products. We reviewed the imported seafood sampling programs
of Canada, the EU, and Japan to determine if their sampling practices
had the potential for enhancing our own practices as well. We reviewed
information on import refusals and alerts identified by Canada, the
EU, and Japan's to determine the types of drug residues identified in
these countries' seafood imports. In addition, we reviewed the
approach the Department of Agriculture's Food Safety and Inspection
Service (FSIS) uses to ensure the safety of imported meat and poultry
products to identify promising practices used by another federal
agency responsible for the safety of imported food products. We
visited the European Commission (Brussels, Belgium) and its inspection
office--the Food and Veterinary Office (Grange, Ireland)--to gain a
better understanding of its programs and oversight controls for
seafood imports. During the visit, we met with officials from the
Belgian and Irish governments to learn about their drug residue
testing programs for seafood imports. In addition, we visited a
government laboratory in Ghent, Belgium, and Rinville, Ireland, each
to learn about the analytical methods available to detect drug
residues in seafood products. We also visited the Port of Antwerp
(Antwerp, Belgium), the largest port of entry for seafood products in
the EU, to learn about oversight controls for seafood imports.
We visited the Port of New York/Newark in Newark, New Jersey, the
largest port of entry for seafood products on the East Coast, and met
with Customs and Border Protection to learn about its activities
related to ensuring the safety of seafood imports. We also visited a
cold storage facility--in close vicinity to the New York/Newark port
and where FSIS inspectors are stationed--to learn about the measures
FSIS uses to ensure the safety of imported meat and poultry products.
During the same trip, we visited FDA's Northeast laboratory in
Jamaica, New York, and a Customs and Border Protection's laboratory in
Newark to learn about the analytical methods available to detect drug
residues in seafood products.
We visited FDA's and NMFS' laboratories that specialize in seafood
research--FDA's Gulf Coast Seafood Laboratory (Dauphin Island,
Alabama) and NMFS's National Seafood Inspection Laboratory
(Pascagoula, Mississippi)--to learn about the research the agencies
are conducting on drug residues in seafood products. We visited a
state actively involved in testing seafood imports--Florida's
Department of Agriculture's laboratory (Tallahassee, Florida) and the
Florida Agricultural and Mechanical University's Research and
Extension facility (Quincy, Florida)--to learn about fish farming
practices.
We interviewed knowledgeable officials from Canada; FDA's Center for
Food Safety and Applied Nutrition, Office of Regulatory Affairs, and
Center for Veterinary Medicine; FSIS; and Japan to better understand
how their respective programs function. For informational purposes, we
spoke with representatives from the states of Alabama and Mississippi
because of their testing program for imported seafood and proximity to
the Gulf of Mexico. To gain various stakeholders' perspectives on the
safety of seafood imports, we also spoke with representatives from:
* industry (Charm Sciences, Inc.; Costco; Darden; and SGS--a third
party entity that certifies seafood farms and processors),
* trade associations (the Catfish Farmers of America; National
Aquaculture Association, National Fisheries Institute; and
Southeastern Fisheries Association, Inc.), and:
* consumer advocacy groups (the Center for Science in the Public
Interest and Food and Water Watch).
To assess the extent to which FDA and NMFS have implemented the 2009
memorandum of understanding (MOU) to enhance federal oversight of
seafood, we analyzed relevant agency documents on its implementation.
Specifically, we obtained and reviewed the 1974 MOU, letters of
notification between the agencies, and MOU guidance provided by each
agency to their respective field offices. We focused on two of the
eight practices identified in our previous work to enhance cooperation
between federal agencies in order to determine the extent that a
collaborative working relationship exists between FDA and NMFS: (1)
establish policies and procedures to facilitate systematic
collaboration across agency lines and (2) identify potential ways to
leverage resources to maximize and sustain collaborative effort. We
did not address the remaining practices: (1) define and articulate a
common outcome; (2) establish mutually reinforcing or joint
strategies; (3) agree on roles and responsibilities; (4) develop
mechanisms to monitor, evaluate, and report on results; (5) reinforce
agency accountability for collaborative efforts; and (6) reinforce
individual accountability for collaborative efforts.[Footnote 18] We
did not address the first three practices because the agencies have
already implemented them; additionally, due to the lack of compatible
policies and leveraging of resources, we did not expect the agencies
to have developed mechanisms for evaluation or agency and individual
accountability. We obtained and reviewed the 2009 MOU implementation
plan as well as compared lists of establishments that received FDA or
NMFS inspections for fiscal years 2005 through 2009 to determine the
extent of inspection duplication. In order to present information on
possible duplication for background purposes, we matched facility
names and addresses using a statistical program; for any potential but
nonexact matches, we independently verified the matches to determine
whether they were correct. We determined that the inspection data were
sufficiently reliable for our purposes. We interviewed knowledgeable
FDA and NMFS headquarters officials to determine their progress in
implementing the 2009 MOU. We reviewed the National Oceanic and
Atmospheric Administration's report on ensuring seafood safety after
an oil spill and the jointly written 2010 protocol for reopening oil-
impacted areas to assess the cooperation between FDA and NMFS in
response to the oil spill in the Gulf of Mexico. We interviewed
officials at NMFS' laboratory in Pascagoula, Mississippi, as well as
FDA's mobile laboratory in Tallahassee, Florida, and Gulf Coast
Seafood Laboratory in Dauphin Island, Alabama, to determine the extent
to which the agencies coordinated efforts and leveraged resources
during this emergency situation.
We conducted this performance audit from April 2010 to April 2011 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
[End of section]
Appendix II: FDA Foreign Facility Inspections and Number of Processing
Facilities in the Country:
Country: Argentina;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 9;
Fiscal year: 2008: 0;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 9;
Number of facilities: 340.
Country: Bangladesh;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 5;
Fiscal year: 2010: 0;
Total inspections: 5;
Number of facilities: 108.
Country: Belize;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 4;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 4;
Number of facilities: 11.
Country: Brazil;
Fiscal year: 2005: 9;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 9;
Number of facilities: 192.
Country: Canada;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 0;
Fiscal year: 2010: 4;
Total inspections: 4;
Number of facilities: 944.
Country: Chile;
Fiscal year: 2005: 0;
Fiscal year: 2006: 11;
Fiscal year: 2007: 0;
Fiscal year: 2008: 5;
Fiscal year: 2009: 6;
Fiscal year: 2010: 0;
Total inspections: 22;
Number of facilities: 348.
Country: China;
Fiscal year: 2005: 6;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 13;
Fiscal year: 2009: 2;
Fiscal year: 2010: 20;
Total inspections: 41;
Number of facilities: 2,744.
Country: Colombia;
Fiscal year: 2005: 3;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 3;
Fiscal year: 2010: 0;
Total inspections: 6;
Number of facilities: 61.
Country: Costa Rica;
Fiscal year: 2005: 5;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 7;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 12;
Number of facilities: 38.
Country: Ecuador;
Fiscal year: 2005: 0;
Fiscal year: 2006: 11;
Fiscal year: 2007: 10;
Fiscal year: 2008: 0;
Fiscal year: 2009: 17;
Fiscal year: 2010: 10;
Total inspections: 48;
Number of facilities: 184.
Country: Fiji;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 13;
Fiscal year: 2008: 0;
Fiscal year: 2009: 5;
Fiscal year: 2010: 0;
Total inspections: 18;
Number of facilities: 46.
Country: Guatemala;
Fiscal year: 2005: 6;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 4;
Fiscal year: 2009: 5;
Fiscal year: 2010: 0;
Total inspections: 15;
Number of facilities: 101.
Country: India;
Fiscal year: 2005: 0;
Fiscal year: 2006: 7;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 1;
Fiscal year: 2010: 0;
Total inspections: 8;
Number of facilities: 477.
Country: Indonesia;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 3;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 3;
Number of facilities: 361.
Country: Italy;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 0;
Fiscal year: 2010: 3;
Total inspections: 3;
Number of facilities: 214.
Country: Japan;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 0;
Fiscal year: 2010: 22;
Total inspections: 22;
Number of facilities: 2,697.
Country: Korea Republic of (South);
Fiscal year: 2005: 7;
Fiscal year: 2006: 0;
Fiscal year: 2007: 6;
Fiscal year: 2008: 0;
Fiscal year: 2009: 11;
Fiscal year: 2010: 0;
Total inspections: 24;
Number of facilities: 1,017.
Country: Malaysia;
Fiscal year: 2005: 9;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 6;
Fiscal year: 2009: 0;
Fiscal year: 2010: 5;
Total inspections: 20;
Number of facilities: 164.
Country: Mexico;
Fiscal year: 2005: 6;
Fiscal year: 2006: 5;
Fiscal year: 2007: 14;
Fiscal year: 2008: 10;
Fiscal year: 2009: 9;
Fiscal year: 2010: 4;
Total inspections: 48;
Number of facilities: 689.
Country: Morocco;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 1;
Fiscal year: 2010: 3;
Total inspections: 4;
Number of facilities: 38.
Country: Panama;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 9;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 9;
Number of facilities: 80.
Country: Peru;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 9;
Fiscal year: 2008: 3;
Fiscal year: 2009: 6;
Fiscal year: 2010: 0;
Total inspections: 18;
Number of facilities: 297.
Country: Philippines;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 11;
Fiscal year: 2010: 0;
Total inspections: 11;
Number of facilities: 303.
Country: Singapore;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 3;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 3;
Number of facilities: 38.
Country: South Africa;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 2;
Fiscal year: 2010: 4;
Total inspections: 6;
Number of facilities: 71.
Country: Spain;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 0;
Fiscal year: 2010: 10;
Total inspections: 10;
Number of facilities: 279.
Country: Surinam;
Fiscal year: 2005: 10;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 3;
Fiscal year: 2010: 0;
Total inspections: 13;
Number of facilities: 17.
Country: Taiwan;
Fiscal year: 2005: 0;
Fiscal year: 2006: 7;
Fiscal year: 2007: 0;
Fiscal year: 2008: 7;
Fiscal year: 2009: 3;
Fiscal year: 2010: 0;
Total inspections: 17;
Number of facilities: 208.
Country: Thailand;
Fiscal year: 2005: 0;
Fiscal year: 2006: 12;
Fiscal year: 2007: 0;
Fiscal year: 2008: 12;
Fiscal year: 2009: 0;
Fiscal year: 2010: 38;
Total inspections: 62;
Number of facilities: 456.
Country: Trinidad & Tobago;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 5;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 5;
Number of facilities: 35.
Country: Venezuela;
Fiscal year: 2005: 7;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 0;
Fiscal year: 2009: 0;
Fiscal year: 2010: 0;
Total inspections: 7;
Number of facilities: 100.
Country: Vietnam;
Fiscal year: 2005: 8;
Fiscal year: 2006: 0;
Fiscal year: 2007: 0;
Fiscal year: 2008: 4;
Fiscal year: 2009: 0;
Fiscal year: 2010: 5;
Total inspections: 17;
Number of facilities: 801.
Country: Total;
Fiscal year: 2005: 76;
Fiscal year: 2006: 53;
Fiscal year: 2007: 61;
Fiscal year: 2008: 95;
Fiscal year: 2009: 90;
Fiscal year: 2010: 128;
Total inspections: 503;
Number of facilities: 13,459.
Source: GAO analysis of FDA data.
Note: The total for the number of facilities represents only those
facilities out of an estimated 17,000 worldwide that FDA inspected
from fiscal years 2005 through 2010.
[End of table]
[End of section]
Appendix III: FDA Import Alerts Related to Drug Residue or HACCP
Violations:
Import alert: 16-119;
Purpose: detention without physical examination of fish and fishery
products for importer and foreign processor combinations not in
compliance with HACCP;
Number of facilities covered and countries: 95 from 29 countries.
Import alert: 16-120;
Purpose: detention without physical examination of fish and fishery
products for foreign processors not in compliance with HACCP;
Number of facilities covered and countries: 69 from 28 countries.
Import alert: 16-124;
Purpose: detention without physical examination of aquaculture seafood
products due to unapproved drugs;
Number of facilities covered and countries: 41 from 7 countries.
Import alert: 16-127;
Purpose: detention without physical examination of crabmeat due to
chloramphenicol;
Number of facilities covered and countries: 29 from 4 countries.
Import alert: 16-129;
Purpose: detention without physical examination of seafood products
due to nitrofurans;
Number of facilities covered and countries: 7 from 4 countries.
Import alert: 16-131;
Purpose: detention without physical examination of aquacultured
catfish, basa, shrimp, dace, and eel from China for the presence of
new animal drugs or unsafe food additives;
Number of facilities covered and countries: all facilities except 12.
Source: GAO analysis of FDA data.
Note: HACCP violations may be related to drug residue problems or
other issues such as sanitation controls.
[End of table]
[End of section]
Appendix IV: Comments from the Department of Health and Human Services:
Note: GAO comments supplementing those in the report text appear at
the end of this appendix.
Department Of Health & Human Services:
Office of the Assistant Secretary for Legislation
Washington, D.C. 20201:
March 23, 2011:
Lisa Shames, Director:
Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Shames:
Attached are comments on the U.S. Government Accountability Office's
(GAO) draft report entitled: "Seafood Safety: FDA Needs to Improve
Oversight of Imported Seafood and Better Leverage Limited Resources"
(GA0-11-286).
The Department appreciates the opportunity to review this report prior
to publication.
Sincerely,
Signed by:
Jim R. Esquea:
Assistant Secretary for Legislation:
Attachment:
[End of letter]
General Comments Of The Department Of Health And Human Services (HHS)
On The Government Accountability Office's (GAO) Draft Report Entitled,
"Seafood Safety: FDA Needs To Improve Oversight Of Imported Seafood
And Better Leverage Limited Resources" (GAO-11-286):
The Department appreciates the opportunity to review and comment on
this draft report.
The draft report represents a baseline against which the Food and Drug
Administration (FDA or the Agency) can measure its ongoing progress,
given the Government Accountability Office (GAO) study's focus on past
strategies, authorities, and practices, and the opportunities
presented to FDA by the newly enacted Food Safety Modernization Act of
2010 (FSMA).
Reading the GAO report may not result in a full understanding of FDA's
multifaceted and risk-informed seafood safety program, which relies on
various measures of compliance with its seafood Hazard Analysis and
Critical Control Points (HACCP) regulations. For imported seafood,
these measures include:[See comment 1]
* inspections of foreign processing facilities,
* sampling of seafood offered for import into the United States,
* domestic surveillance sampling of imported products,
* inspections of seafood importers,
* evaluations of filers of seafood products,
* foreign country program assessments, and,
* relevant information from our foreign partners and FDA overseas
offices.
FDA has increased the number of foreign site inspections in recent
years. FDA is also implementing the Predictive Risk-based Evaluation
for Dynamic Import Compliance Targeting (PREDICT), which will improve
on our current electronic screening system by targeting higher risk
products for exam and sampling and minimizing the delays of shipments
of lower risk products. PREDICT will improve our ability to detect
trends and investigate patterns. This, in turn, will help to make more
efficient use of FDA's import resources and allow FDA to adjust its
import sampling level for seafood products over time and as
appropriate. [See comment 2]
In addition, FDA conducts foreign country assessments to evaluate a
country's aquaculture systems and controls and to assess products. FDA
also assesses the country's laws for, and implementation of, control
of animal drug residues in the aquaculture products it ships to the
United States. In this respect, FDA's assessments are similar to the
European Union country audits that GAO references in the draft report.
[See comment 3]
Whereas a facility inspection offers a snapshot of an individual
facility's compliance with HACCP regulations, a country assessment is
a systems review that collects information that an investigator cannot
collect during a facility inspection. A country assessment offers FDA
a broad view of the ability of the country's industry and regulatory
infrastructure to control aquaculture drugs. During a country
assessment, FDA interviews the country's competent authority
officials”-at headquarters and regional/local offices and drug residue
testing laboratories-”and industry-”during visits to farms, processing
plants, animal drug and fish feed selling centers and stores, and
trade associations. An assessment allows FDA to become familiar with
the controls that a country's competent authority is implementing for
the distribution, availability, and use of animal drugs, which serves
as the foundation for the country's processors to meet the
requirements of FDA's HACCP regulation and other laws and regulations
relevant to the safety of aquaculture products intended for the U.S.
market.
FDA uses information from country assessments to better target (i.e.,
increase or decrease) surveillance sampling of imported aquaculture
products; to inform its decisions on what new analytical methods it
needs to develop and what drugs or chemicals it should target for
surveillance sampling; to inform its planning of foreign seafood HACCP
inspections; to provide additional evidence for potential regulatory
actions, such as an import alert; to improve collaboration with
foreign government and industry contacts to achieve better compliance
with FDA's regulatory requirements; and to better understand the
causes for significant changes in a country's drug residue problem,
such as a sudden spike in noncompliant samples. FDA provided GAO with
several examples of the value and utility of the country assessment
program, including the following:
* The assessment trip to China in 2006 was a key consideration in
issuance of the country-wide Import Alerts for specific aquaculture
products from China in 2007.
* The country assessments for China in 2006, Chile in 2008, and India
in 2010 were considered and resulted in increased sampling and testing
under the compliance program and special assignments for aquaculture
products from these countries (e.g., eel from China, salmon from
Chile, and shrimp from India).
The country assessment program helps FDA direct its foreign inspection
and border surveillance resources more effectively and efficiently and
allows FDA to work directly with countries to resolve drug residue
problems.
FDA conducts its seafood safety oversight activities in conformance
with its statutory authorities, which have recently been expanded by
FSMA. FSMA represents the first major overhaul of FDA's food safety
law in more than 70 years and will transform FDA's food safety
program. FSMA closes significant and longstanding gaps in FDA's food
safety authority, with new safeguards to prevent, rather than react,
to food safety problems. Most significantly for purposes of this
study, FSMA gives FDA important new tools to ensure that imported
seafood is as safe as domestic seafood:
* Suspension of registration: FDA can suspend registration of a
facility if it determines that the food poses a reasonable probability
of serious adverse health consequences or death. If the registration
of a facility is suspended, food from that facility cannot be imported
or exported into the United States, among other things. [See section
102 of FSMA.]
* Enhanced product tracing abilities: FDA is directed to establish a
system that will enhance its ability to track and trace both domestic
and imported foods. [See section 204 of FSMA.]
* Reliance on inspections by other agencies: FDA is explicitly
authorized to rely on inspections by other federal, state and local
agencies to meet its increased inspection mandate. FSMA also allows
FDA to enter into agreements with state and local governments to
leverage resources with respect to the inspection of facilities, both
domestic and foreign, as well as imports. [See section 201 and 209 of
FSMA.]
* Voluntary Qualified Importer Program: FSMA requires FDA to establish
within 18 months a program for expedited review and importation of
products from importers voluntarily participating in a qualified
importer program. [See section 301 of FSMA.]
* Inspection of foreign food facilities: FSMA authorizes FDA to enter
into agreements with foreign countries to facilitate the inspection of
registered foreign facilities and require the inspection resources be
directed to those facilities, suppliers, and food types that present a
high risk. FSMA also prohibits the importation of food from foreign
facilities that refuse to permit, limit, or unduly delay U.S.
inspections. [See section 306 of FSMA.]
FDA's country assessment program will be useful in developing the
program for accredited third-parties called for under FSMA, which may
include foreign governments and agencies of foreign governments that
meet FDA model standards to certify food imports.
In addition to implementing these new FSMA authorities, FDA will
continue the national residue monitoring program and recognizes the
benefit of such a program to ensure that foods are not contaminated
with illegal animal drug residues. In earlier reports, GAO has called
on FDA to consider accrediting private laboratories to test seafood.
FSMA directs FDA to establish a program for testing of food by
accredited laboratories and will require that food be tested by
accredited laboratories in some circumstances, such as in support of
admission of imported food. FDA is developing the laboratory
accreditation program as part of its FSMA implementation efforts.
Response to GAO's 3 Recommendations for Executive Action:
No. 1 - Studying the Feasibility of Adopting Other Practices Used by
Other Entities:
GAO recommends that FDA study the feasibility of adopting practices
used by other entities, such as requiring foreign countries that want
to export seafood to the United States to develop a national residues
monitoring plan to control the use of aquaculture drugs, to more
efficiently ensure the safety of imported seafood, and report its
findings to the Secretary of Health and Human Services.
This GAO recommendation appears to envision FDA requiring, as a
condition of entry into the United States, a national residue
monitoring program in the source country for all aquaculture fish.
Prior to the passage of FSMA, FDA lacked the authority to demand
foreign governmental controls for food as a condition of entry into
the United States.
As part of implementing FSMA, FDA will determine whether the
legislation supports the kind of precondition envisioned by GAO for
entry of aquacultured fish from some or all countries that export to
the United States.
No. 2 - Import Sampling Program:
GAO recommends that FDA develop a more comprehensive import sampling
program for seafood by more effectively using its laboratory resources
and taking into account the imported seafood sampling programs of
other entities and countries.
FDA agrees that effective use of laboratory resources and import
sampling programs are important facets of a comprehensive and risk-
informed program to assure seafood safety. FDA regulatory testing of
residues in seafood, to serve the Agency's regulatory purposes, must
be rigorous and confirmatory. Such testing requires a high degree of
analytic proficiency, relies on the most advanced laboratory
instrumentation, and is supported by significant research efforts. The
regulatory tests that FDA must conduct are not comparable to the less
rigorous and non-confirmatory screening methods used in Canada, the
European Union (EU), and Japan, as referenced by GAO.
FDA offers the following example to illustrate this point. In 2008,
the EU found nitrofuran in over 50 fresh water shrimp (Macrobrachium)
samples. The positive results came from one laboratory in Belgium
that, over a six week period, found positive results in 41 of these
samples. During extensive sampling elsewhere over the same six week
period, only four samples were found to be positive in the United
Kingdom and one each in New Zealand and Germany. The Bangladesh
industry did voluntarily stop shipments to the EU based on these
results. However, a closer look at the EU test results revealed that
the laboratory in Belgium that found the 41 positive samples had
altered the analytical procedure to include whole body shrimp with the
shell on. Two studies conducted independently by Dr. Christof van
Poucke of Ghent University in Belgium and Dr. Glenn Kennedy of the
Agri-Food & Biosciences Institute in Belfast, United Kingdom,
concluded that semicarbazide, the marker used to detect nitrofurazone,
occurs naturally in the shell of crustaceans.[Footnote 1]
FDA is evaluating proposed research to further expand residue and
species coverage and identify areas for improved laboratory testing
efficiencies. Many of FDA's current methods describe the testing of
one or two species of fish for one residue, or of one or two species
of fish for a class of compounds. FDA is working to develop methods
that address multiple species and/or multiple classes of drugs in one
method. For example, FDA is attempting to implement a method for
shrimp that tests for 15 compounds and a finfish method for multiple
classes of compounds. These multiple species/multiple drug class
methods would reduce the number of methods FDA must support and will
permit greater screening volume.
No. 3 - Enhancing Collaboration with NMFS:
GAO recommends that FDA develop a strategic approach with specific
timeframes for enhancing collaborative efforts with the National
Oceanic and Atmospheric Administration's (NOAA) National Marine
Fisheries Service (NMFS) and better leveraging NMFS inspection
resources.
FDA's current collaboration with NMFS is strong, as illustrated by the
multi-agency cooperation on the Deep Water Horizon Oil Spill Response
and two recent FDA regulatory actions wherein NOAA worked with FDA,
under the 2009 FDA-NMFS Memorandum of Understanding, to coordinate
agency efforts and effect food safety compliance.
Moreover, FDA agrees that it is important to maintain and foster this
collaborative and effective working relationship with NMFS. FDA will
work with NMFS to develop strategic approaches for enhancing
collaboration and better leveraging seafood inspection resources.
Efforts made to date by FDA and NMFS to train and ultimately certify
NMFS inspectors on FDA regulatory procedures and FDA's expectations
under the seafood HACCP regulation represent significant investments
by both agencies in a program where FDA can take maximum benefit from
NMFS inspection activities in the United States and abroad. This work
remains a priority and will continue to evolve and develop as
resources permit.
HHS Comment Letter Footnote:
[1] For more information, see press release from Seafood Importers and
Processors Alliance at following URL: [hyperlink,
http://www.asemaquaculture.org/files/sipa/sipa_press_release.pdf].
GAO Comments:
The following are GAO's comments on the Department of Health and Human
Services' (HHS) letter dated March 23, 2011.
1. We acknowledge that FDA has a multifaceted seafood safety program,
and our report discusses various measures that the agency uses to
ensure the safety of imported seafood. For example, our report
discusses facility and importer HACCP inspections, FDA's drug residue
sampling program, and foreign country assessments. As we note in the
report, these measures are limited when compared to more comprehensive
reviews conducted by the EU and the Department of Agriculture's FSIS.
FDA notes that another measure is information from its overseas
offices. In our September 2010 report on FDA's overseas offices,
however, we found that although the offices have engaged in a variety
of activities to help ensure the safety of all FDA imported products,
overseas FDA officials report facing a variety of challenges that may
limit their ability to enhance agency oversight.[Footnote 19]
2. HHS notes that FDA is also implementing the Predictive Risk-based
Evaluation for Dynamic Import Compliance Targeting (PREDICT), which
the department states will improve its current electronic screening
system by targeting higher risk products for exam and sampling. The
department notes that PREDICT will make more efficient use of FDA's
import resources and allow the agency to adjust its import sampling
level for seafood products over time. In our April 2010 report, we
found that according to FDA officials, the agency had delayed a
nationwide rollout of PREDICT due primarily to information technology
infrastructure problems, such as server crashes and overloads.
[Footnote 20]
3. HHS describes the role of FDA's foreign country assessments in
ensuring the safety of imported seafood by evaluating a foreign
country's aquaculture systems and controls and to assess products. We
state in our report, however, that until recently, FDA had not
developed written standard operating procedures for conducting its
foreign country assessments. In its comments, HHS states that, during
a foreign country assessment, FDA assesses a foreign country's laws
and their implementation for the control of animal drug residues in
the aquaculture products it ships to the United States. However, in
the absence of written criteria, standards, and program policies, it
may be difficult for FDA to carry on such an effort in a systematic or
consistent manner. In its comments, HHS describes the breadth and
value of FDA's foreign country assessments as part of its import
oversight program, but these assessments are not identified in FDA's
publicly available information as is its HACCP inspection program. FDA
also has not documented that these assessments are linked to any
inspection or sampling program.
[End of section]
Appendix V: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames, (202) 512-3841 or shamesl@gao.gov:
Staff Acknowledgments:
In addition to the individual named above, Jose Alfredo Gomez
(Assistant Director), David Moreno (Analyst-in-Charge), David Adams,
Nancy Crothers, Diana Goody, Christine Ramos, and Kiki Theodoropoulos
made key contributions to this report. Important contributions were
also made by Kevin Bray, Michele Fejfar, and Catherine Hurley.
[End of section]
Footnotes:
[1] FDA, Enhanced Aquaculture and Seafood Inspection-Report to
Congress (Washington, D.C., Nov. 20, 2008).
[2] The 2008 Farm Bill amended the Federal Meat Inspection Act to give
the Department of Agriculture responsibility for the mandatory
inspection of catfish and catfish products. On February 24, 2011, the
department published a proposed rule on this matter. The Farm Bill
amendments specified that they would not apply until final regulations
are issued.
[3] GAO, Oversight of Food Safety Activities: Federal Agencies Should
Pursue Opportunities to Reduce Overlap and Better Leverage Resources,
[hyperlink, http://www.gao.gov/products/GAO-05-213] (Washington, D.C.:
Mar. 30, 2005).
[4] GAO, Results Oriented Government: Practices That Can Help Enhance
and Sustain Collaboration among Federal Agencies, [hyperlink,
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21,
2005).
[5] See our most recent series, see GAO, High-Risk Series: An Update,
[hyperlink, http://www.gao.gov/products/GAO-11-278] (Washington, D.C.:
February 2011). Also see GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007).
[6] GAO, Seafood Fraud: FDA Program Changes and Better Collaboration
among Key Federal Agencies Could Improve Detection and Prevention,
[hyperlink, http://www.gao.gov/products/GAO-09-258] (Washington, D.C.:
Feb. 19, 2009).
[7] The five drugs include: florfenicol, sulfamerazine, chorionic
gonadotropin, oxytetracycline dihydrate, oxytetracycline
hydrochloride, and a drug combination of sulfadimethoxine and
ormetoprim. For the purpose of our report, we counted products (such
as oxytetracycline dihydrate and oxytetracycline hydrochloride) that
contain the same regulated ingredient (oxytetracycline) as one drug to
ensure the total number of different drugs approved across countries
is comparable.
[8] The monitoring plan includes information on the structure of the
foreign government agency responsible for developing and implementing
the plan, a list of approved laboratories responsible for residue
testing and the status of their accreditation, the rules covering the
collection of the official samples, and the sampling levels, among
other things.
[9] According to FDA, agency officials became aware of the ban when
Bangladesh scientists discussed it during a training session in
Bangladesh that took place about 5 months after the ban began.
[10] FDA just recently added the seventh laboratory in fiscal year
2010. The seven are the Denver District, Kansas City District,
Northeast Regional, Pacific Southwest Regional, Pacific Northwest
Regional, Southeast Regional, and Arkansas Regional laboratories.
According to FDA officials, the other six laboratories not conducting
food work are dedicated to pharmaceuticals and devices, among other
things.
[11] According to FDA officials, the agency is working to develop and
validate new methods to detect other drug residues including emamectin
benzoate.
[12] [hyperlink, http://www.gao.gov/products/GAO-06-15].
[13] [hyperlink, http://www.gao.gov/products/GAO-06-15].
[14] [hyperlink, http://www.gao.gov/products/GAO-06-15].
[15] Department of Health and Human Services, Office of Inspector
General, FDA Inspections of Domestic Food Facilities (Washington,
D.C., April 2010).
[16] [hyperlink, http://www.gao.gov/products/GAO-05-213].
[17] GAO, Food Safety: FDA's Imported Seafood Safety Program Shows
Some Progress, but Further Improvements Are Needed, [hyperlink,
http://www.gao.gov/products/GAO-04-246] (Washington, D.C.: Jan. 30,
2004).
[18] [hyperlink, http://www.gao.gov/products/GAO-06-15].
[19] GAO, Food and Drug Administration: Overseas Offices Have Taken
Steps to Help Ensure Import Safety, but More Long-Term Planning Is
Needed, [hyperlink, http://www.gao.gov/products/GAO-10-960]
(Washington, D.C.: Sept. 30, 2010).
[20] GAO, Food Safety: FDA has Begun to Take Action to Address
Weaknesses in Food Safety Research, but Gaps Remain, [hyperlink,
http://www.gao.gov/products/GAO-10-182R] (Washington, D.C.: Apr. 23,
2010).
[End of section]
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