Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are
Inconsistent and Unreliable (Chapter Report, 04/30/98, GAO/RCED-98-103).
Pursuant to a congressional request, GAO reviewed efforts of federal
programs to ensure the safety of food imports, focusing on the: (1)
differences in the agencies' authorities and approaches for ensuring the
safety of imported foods; (2) agencies' efforts to target their
resources on foods posing risks; and (3) weaknesses in the controls over
imported foods.
GAO noted that: (1) federal agencies cannot ensure that the growing
volume of imported foods is safe for consumers; (2) although the Food
Safety and Inspection Service (FSIS) and the Food and Drug
Administration (FDA) require imported foods to meet the same standards
as domestic foods, their approaches to enforcing these requirements
differ; (3) by law, FSIS places the principal burden for safety on the
exporting countries by allowing imports only from those countries with
food safety systems it deems to be equivalent to the U.S. system; (4)
FDA, lacking such legal authority, allows food imports from almost any
country and takes on the burden of ensuring the safety of imported foods
as they arrive at U.S. ports of entry; (5) relying on port-of-entry
inspections to detect and prevent unsafe foods is ineffective, given
that: (a) this approach does not ensure that foods are produced under
adequately controlled conditions; (b) FDA currently inspects less than 2
percent of all foreign shipments; and (c) inspection will not detect
some organisms, such as Cyclospora, for which visual inspections and
laboratory tests are inadequate; (6) FSIS and FDA are not deploying
their inspection resources to maximum advantage; (7) FSIS focuses its
inspection and testing resources on shipments from exporting firms with
a history of violations; (8) however, many of the violations may bear
little relationship to food safety; (9) using available data on
health-related risks from shipments that do not meet U.S. standards
could help FSIS focus more closely on the imports posing the greater
risks; (10) FDA's annual work plan does not set achievable targets for
inspection activities; (11) as a result, inspectors do not have clear
guidance for conducting inspections; (12) FDA does not make health risk
data readily available to guide inspectors' selections; (13) when making
decisions on which shipments to inspect, FDA relies on importers'
descriptions of shipments' contents, which are often incorrect; (14)
FDA's procedures for ensuring that unsafe imported foods do not reach
U.S. consumers are vulnerable to abuse by unscrupulous importers; (15)
in some cases, when FDA decides to inspect shipments, the importers have
already marketed the goods; (16) in other cases, when FDA finds
contamination and calls for importers to return shipments to the Customs
Service for destruction or reexport, importers ignore this requirement
or substitute other goods for the original shipment; and (17) such cases
of noncompliance seldom result in a significant penalty.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: RCED-98-103
TITLE: Food Safety: Federal Efforts to Ensure the Safety of
Imported Foods Are Inconsistent and Unreliable
DATE: 04/30/98
SUBJECT: Consumer protection
Contaminated foods
Food inspection
Food industry
Import regulation
Safety standards
Fraud
Management information systems
Meat inspection
Poultry inspection
IDENTIFIER: FSIS Automated Import Information System
FDA Operational and Administrative System for Import
Support Database
Cyclospora Parasite
Salmonella Enteritidis Bacteria
FDA Import Alert Database
FDA Low-Acid Canned Foods Database
FDA Laboratory Management System Database
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Cover
================================================================ COVER
Report to the Chairman, Permanent Subcommittee on Investigations,
Committee on Governmental Affairs, U.S. Senate
April 1998
FOOD SAFETY - FEDERAL EFFORTS TO
ENSURE THE SAFETY OF IMPORTED
FOODS ARE INCONSISTENT AND
UNRELIABLE
GAO/RCED-98-103
Safety of Imported Foods
(150645)
Abbreviations
=============================================================== ABBREV
AIIS - Automated Import Information System
CDC - Centers for Disease Control and Prevention
CLEAN - Closing Loopholes to Ensure Acceptable Nutrition
FDA - Food and Drug Administration
FSIS - Food Safety and Inspection Service
GAO - General Accounting Office
HACCP - Hazard Analysis and Critical Control Point
HHS - U.S. Department of Health and Human Services
OASIS - Operational and Administrative System for Import Support
USDA - U.S. Department of Agriculture
Letter
=============================================================== LETTER
B-279329
April 30, 1998
The Honorable Susan M. Collins
Chairman, Permanent Subcommittee
on Investigations
Committee on Governmental Affairs
United States Senate
Dear Madam Chairman:
This report responds to your request that we evaluate the federal
government's efforts to ensure the safety of imported foods. The
report contains recommendations to the Congress and to the
Secretaries of Agriculture and of Health and Human Services that are
designed to enhance the federal government's authority to review the
safety of food imports, improve the effectiveness and efficiency of
systems and staff to screen imports, and strengthen internal
controls.
As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days
from the date of this letter. At that time, we will send copies to
interested parties and make copies available to others upon request.
Please call me at (202) 512-5138 if you or your staff have any
questions about this report. Major contributors to the report are
listed in appendix VI.
Sincerely yours,
Robert A. Robinson
Director, Food and
Agriculture Issues
EXECUTIVE SUMMARY
============================================================ Chapter 0
PURPOSE
---------------------------------------------------------- Chapter 0:1
Each year, millions of Americans become ill after eating tainted
foods, and thousands die. Ensuring the safety of domestically
produced foods is a daunting task, but the challenge of ensuring the
safety of the entire food supply is even more difficult as Americans
consume more foods imported from other countries. The primary
responsibility for ensuring the safety of imported foods is split
between two federal agencies--the U.S. Department of Agriculture's
Food Safety and Inspection Service (FSIS) and the Department of
Health and Human Service's Food and Drug Administration (FDA).
Concerned about the safety of imported foods, the Chairman of the
Permanent Subcommittee on Investigations, Senate Committee on
Governmental Affairs, asked GAO to review the efforts of federal
programs to ensure the safety of food imports. Specifically, this
report discusses (1) the differences in the agencies' authorities and
approaches for ensuring the safety of imported foods and (2) the
agencies' efforts to target their resources on foods posing risks.
In addition, the report discusses weaknesses in the controls over
imported foods.
BACKGROUND
---------------------------------------------------------- Chapter 0:2
Foodborne illnesses in the United States are widespread and costly.
The magnitude of the problem is uncertain, however, because these
illnesses are underreported and health officials often cannot
determine their source. As GAO reported in May 1996,\1 up to 81
million cases of foodborne illnesses and as many as 9,100 deaths from
these illnesses occur each year. According to the U.S. Department
of Agriculture's Economic Research Service, the costs for medical
treatment and productivity losses associated with these illnesses and
deaths range from $6.6 billion to $37.1 billion. Recent outbreaks of
foodborne illness demonstrate that imported foods have introduced new
risks or increased the incidence of familiar illnesses. The
increased consumption of imported foods in the United States further
heightens the risk of illness.
FSIS has jurisdiction over meat, poultry, and some egg products,
while FDA regulates all other foods. FSIS and FDA work closely with
the Customs Service (Customs) and the Centers for Disease Control and
Prevention (CDC). Customs refers imported foods to FSIS or FDA for
their review before releasing the shipment into U.S. commerce. CDC
monitors the incidence of foodborne illness; works with state and
local health departments to investigate outbreaks of illness; and
collaborates with FSIS, FDA, and others to conduct research on
foodborne diseases.
--------------------
\1 Food Safety: Information on Foodborne Illnesses (GAO/RCED-96-96,
May 8, 1996).
RESULTS IN BRIEF
---------------------------------------------------------- Chapter 0:3
Federal agencies cannot ensure that the growing volume of imported
foods is safe for consumers. Although the Food Safety and Inspection
Service and the Food and Drug Administration require imported foods
to meet the same standards as domestic foods, their approaches to
enforcing these requirements differ. By law, the Food Safety and
Inspection Service places the principal burden for safety on the
exporting countries by allowing imports only from those countries
with food safety systems it deems to be equivalent to the U.S.
system. The Food and Drug Administration, lacking such legal
authority, allows food imports from almost any country and takes on
the burden of ensuring the safety of imported foods as they arrive at
U.S. ports of entry. Relying on port-of-entry inspections to detect
and prevent unsafe foods is ineffective, given that (1) this approach
does not ensure that foods are produced under adequately controlled
conditions, (2) the Food and Drug Administration currently inspects
less than 2 percent of all foreign shipments, and (3) inspection will
not detect some organisms, such as Cyclospora, for which visual
inspections and laboratory tests are inadequate.
The Food Safety and Inspection Service and the Food and Drug
Administration are not deploying their inspection resources to
maximum advantage. The Food Safety and Inspection Service focuses
its inspection and testing resources on shipments from exporting
firms with a history of violations, such as contamination, processing
defects, and incorrect or missing shipping labels. However, many of
the violations, such as the incorrect or missing shipping labels, may
bear little relationship to food safety. Using available data on
health-related risks from shipments that do not meet U.S. standards
could help the Food Safety and Inspection Service focus more closely
on the imports posing the greater risks. The Food and Drug
Administration's annual work plan does not set achievable targets for
inspection activities; as a result, inspectors do not have clear
guidance for conducting inspections. For example, in fiscal year
1997, the Food and Drug Administration conducted only half of its
planned inspections of imported foods. Furthermore, the Food and
Drug Administration does not make health risk data readily available
to guide inspectors' selections. In addition, when making decisions
on which shipments to inspect, the Food and Drug Administration
relies on importers' descriptions of shipments' contents, which are
often incorrect. As a result, the agency's resources may not be
focused on imported foods posing the greater safety risk.
The Food and Drug Administration's procedures for ensuring that
unsafe imported foods do not reach U.S. consumers are vulnerable to
abuse by unscrupulous importers. For example, when an exporting firm
has a history of violations, the Food and Drug Administration detains
shipments from that firm without sampling or analysis. Importers of
these detained shipments have the right to present evidence, such as
private laboratory tests, showing that the product complies with U.S.
standards. However, because the Food and Drug Administration does
not have the explicit authority to require importers to use certain
laboratories, importers can choose the laboratories that select the
samples and perform the tests to prove compliance. For other
shipments, importers retain control of the goods while the Food and
Drug Administration decides whether to inspect them or while tests
are being conducted on them. In some cases, when the Food and Drug
Administration decides to inspect shipments, the importers have
already marketed the goods. In other cases, when the Food and Drug
Administration finds contamination and calls for importers to return
shipments to the Customs Service for destruction or reexport,
importers ignore this requirement or substitute other goods for the
original shipment. Such cases of noncompliance seldom result in a
significant penalty.
PRINCIPAL FINDINGS
---------------------------------------------------------- Chapter 0:4
LACK OF EQUIVALENCY
AUTHORITY DIMINISHES FDA'S
ABILITY TO PROTECT U.S.
CONSUMERS
-------------------------------------------------------- Chapter 0:4.1
FSIS has the statutory authority to require the exporters of meat and
poultry products to have food safety systems equivalent to the system
in the United States. In enforcing this requirement, FSIS has
determined that 37 countries have food safety systems equivalent to
the United States' and are therefore eligible to export meat and
poultry products to this country. (App. II lists the eligible
countries.) FDA's authority, on the other hand, requires imported
foods to meet U.S. standards. FDA does not have the authority to
require the exporting country to have an equivalent safety system in
place. In 1997, administration initiatives on food safety proposed
that FDA be given this "equivalency authority."
FSIS has used its equivalency authority to shift the primary
responsibility for food safety to the exporting countries. In so
doing, the agency can leverage its resources by reviewing exporting
countries' compliance with U.S. requirements, rather than by
depending on resource-intensive inspections at ports of entry. FDA,
on the other hand, relies on selecting and testing import samples at
ports of entry to ensure that foods are safe. Such an approach, when
used as the sole means of assessing the safety of foods, has been
widely discredited as an effective protective measure by the Food and
Agriculture Organization of the United Nations, an FDA advisory
committee, and GAO for a number of reasons. For example, individual
products tested at ports of entry may not represent the health risks
of the entire shipment. The ineffectiveness of FDA's approach is
magnified by its inability to keep pace with a rising level of
imports. FDA's coverage of import shipments has fallen from an
estimated 8 percent in fiscal year 1992 to an estimated 1.7 percent
in fiscal year 1997.
AGENCIES COULD MORE
EFFECTIVELY TARGET RESOURCES
ON UNSAFE FOODS
-------------------------------------------------------- Chapter 0:4.2
Although both FSIS and FDA use computer systems to screen each import
shipment and to help identify the import shipments requiring
inspectors to take action, the agencies have not designed their
systems to take the best advantage of available data so that they can
target those imported foods posing the greater health risks. FSIS
relies primarily on the violation history of previous shipments from
the exporting firm to target entries for inspectors' action; this
violation history may not always indicate the shipments more likely
to pose health threats. For example, many violations, such as
incorrect shipping labels, may not directly affect consumers' safety.
As a result, FSIS is using some inspection resources to review
shipments that pose lower food safety risks. However, information is
available on the relative health risks of specific types of imported
foods, such as ground or deboned beef, that would enable FSIS to
further improve its computer screening system.
FDA's system for selecting imports for examination relies primarily
on inspectors' judgment, and FDA's guidance and information to aid
inspectors' decisions are often not useful. FDA's annual work plan,
which identifies, among other things, the number of imported food
inspections and tests each field office is expected to conduct,
guides inspectors' judgment; but the work plan is unrealistic because
it does not make allowances for the time needed to investigate
emergencies and consumers' complaints. Because the number of
activities set out in the work plan is generally not attainable, the
work plan is not useful when making inspection and testing decisions,
according to managers in field locations who reported the views of
inspectors. In addition, FDA's computer system for screening
imported food shipments is not programmed to help inspectors
effectively use laboratory test results, violation histories, and
other information to identify shipments posing the greater food
safety risks. Finally, the information identifying the contents of
imported food shipments is entered directly into FDA's computer
system by importers, some of whom have an incentive to misrepresent
their goods in the interest of avoiding inspectors' attention. After
an importer demonstrates competency with the system, FDA
retrospectively verifies a sample of the importer-provided
information. Although the agency frequently identifies errors, it
has recently taken no corrective action other than counseling the
filer. Thus, FDA has no assurance that importers are accurately
describing their goods and that it is identifying shipments that
should be scrutinized.
WEAKNESSES IN IMPORT
CONTROLS ALLOW ENTRY OF
UNSAFE PRODUCTS
-------------------------------------------------------- Chapter 0:4.3
FDA and Customs have historically had problems stopping importers
from distributing unsafe foods under FDA's jurisdiction. Recent
investigations by Customs confirm that these problems continue.
Nevertheless, the procedures for controlling suspect shipments
continue to permit importers to easily circumvent them.
In particular, FDA does not maintain effective control over the
products it automatically detains because of past violations. In
lieu of requiring that these shipments be destroyed or reexported,
FDA requires importers to establish that the contents are safe. As
proof, FDA allows them to present evidence, such as private
laboratory test results, to show that the shipments meet U.S. safety
standards. However, because the agency does not have the explicit
authority to require importers to use certain laboratories, importers
are free to choose the laboratories that will perform the tests.
While FDA expects these laboratories to follow the agency's written
sampling guidelines and reviews the test results submitted to the
agency, it does not control the selection of the samples tested by
the private laboratories or certify acceptable private laboratories
to perform these tests. FDA has found numerous discrepancies between
its test results and those from private laboratories for the same
shipments. Customs officials and FDA inspectors told GAO that
importers have been known to substitute shipments that have been
tested as safe for samples of other shipments that are suspect.
Unlike FSIS, which controls the storage of imported foods after they
are presented for inspection until their release into the U.S.
market, Customs usually allows importers to retain possession of
their shipments until FDA and Customs clear them for entry into U.S.
commerce. According to FDA and Customs officials, imported food
shipments under FDA's jurisdiction are often not made available for
FDA's inspection as required or are not properly disposed of when
refused entry into U.S. commerce. Customs and FDA inspectors have
found many instances in which importers substituted safe products for
inspection, rather than the imported products FDA wanted to inspect.
In other instances, when the tested products failed laboratory tests,
importers substituted other products for destruction, rather than the
imported products FDA wanted to destroy. In each situation, FDA
inspectors believe the original imported food was sold in the U.S.
market and presumably consumed. A joint Customs-FDA operation to
test controls over foods at one port found that evasion was common.
The evasion of safety requirements is seldom punished effectively.
While FDA and Customs rely on the bonds presented by the importer,
which cover the value of the shipment, as the principal deterrent
against noncompliance with laws, the collection of damages against
violators is uneven and uncertain. For example, at one port, Customs
collected about 2 percent of the damages originally assessed in 24
cases in 1997. In a previous report, GAO found that even if the
maximum damages had been collected, the importer would still have
made a profit on the sale of the shipment.\2 Thus, the bonds do not
represent an effective deterrent.
--------------------
\2 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
RECOMMENDATIONS
---------------------------------------------------------- Chapter 0:5
In order to strengthen FDA's ability to ensure the safety of imported
foods, GAO recommends that the Congress require all foods eligible
for import to the United States, not just meat and poultry, be
produced under equivalent food safety systems.
In the body of this report, GAO also makes several recommendations to
the Secretary of Health and Human Services and the Secretary of
Agriculture to improve the effectiveness and efficiency of their
import review systems and procedures by targeting inspection
resources on foods posing greater health risks.
AGENCY COMMENTS
---------------------------------------------------------- Chapter 0:6
GAO provided copies of a draft of this report to the Department of
Health and Human Services' Food and Drug Administration, the U.S.
Department of Agriculture's Food Safety and Inspection Service, and
the Department of the Treasury's U.S. Customs Service for review and
comment. Their comments and GAO's responses are in appendixes III,
IV, and V, respectively. The Centers for Disease Control and
Prevention provided technical comments in response to the draft
report, and these have been incorporated as appropriate.
FDA generally agreed with the report and said it raises a number of
issues that need to be addressed. FDA agreed with GAO that FDA needs
additional legislative authority to control the safety of imported
foods, but the agency disagreed that any authority to require
equivalency should be mandatory because such mandatory authority
would disrupt trade if implemented at one time. GAO disagrees that
FDA should have discretion over applying equivalency requirements and
believes the agency could implement the requirements in stages. GAO
believes that equivalency should be mandatory for all imported foods
and could be implemented in a manner that would not unnecessarily or
unfairly disrupt trade. Mandatory authority to require equivalency
would address weaknesses in FDA's inspection approach at ports of
entry, enable FDA to leverage its staff resources by sharing the
responsibility for food safety with the exporting countries, and
compel FDA to take a proactive approach in preventing food safety
problems instead of requiring equivalency after problems are
identified. The Congress could provide reasonable time frames that
would allow equivalency to be implemented over a number of years.
FDA also generally agreed with the report's recommendation regarding
its import screening system. FDA described planned actions to
improve the efficiency of its automated import screening system and
to take appropriate corrective actions in its electronic filer
program. FDA did not agree with GAO's characterization of its system
for communicating inspection priorities to its inspectors or the
associated recommendation in GAO's draft report to improve this
system. Specifically, FDA said that its annual work plan and
compliance programs provide sufficient guidance to inspectors to help
them make decisions about which shipments to inspect. GAO continues
to believe that the priority-setting guidance provided to inspectors,
even as it is described in FDA's comments, is confusing and
inconsistent. As a result, inspectors may not be selecting shipments
to inspect that pose the greater food safety risk to consumers. GAO
has, however, modified its recommendation to better reflect the
nature of the problem and to provide FDA with more flexibility to
address it.
FSIS concurred with the facts in the report and stated that it will
consider GAO's recommendation in its evaluation of port-of-entry
inspection procedures and automated systems.
Customs also provided explanations of its actions to enforce
requirements for controlling imported foods and raised concerns about
the extent of the problem regarding the substitution of safe food
products for actual products for inspection.
INTRODUCTION
============================================================ Chapter 1
Foodborne illnesses constitute a major public health problem in the
United States. In May 1996, we reported that up to 81 million cases
of foodborne illnesses and as many as 9,100 deaths associated with
those illnesses are estimated to occur each year.\1 While foodborne
illnesses are often temporary maladies that may not require medical
treatment, they can sometimes cause acute and chronic illnesses, such
as kidney failure in infants and young children, stillbirths, and
various types of arthritis. According to the U.S. Department of
Agriculture's Economic Research Service, in 1996, the estimated
annual cost of medical treatments and productivity losses associated
with these illnesses ranged from $6.5 billion to $37.1 billion. The
actual number of foodborne illnesses, however, is unknown because
many people who become ill do not seek treatment, and doctors may not
associate the illnesses they do see with a food source or, if they
do, report it to state or local health agencies.\2 Even when a
foodborne illness is reported, health agencies may not be able to
trace the illness to a specific food or its origin.
--------------------
\1 Food Safety: Information on Foodborne Illnesses (GAO/RCED-96-96,
May 8, 1996).
\2 Federal and state agencies began in 1995 to collect more
comprehensive data on foodborne illness in the United States to
overcome the scarcity of data. This effort will help identify the
frequency with which specific foods are associated with certain
pathogens, but it does not address the difficulties of tracing an
adulterated food back to its country of origin.
IMPORTED FOOD'S GROWING ROLE IN
U.S. FOOD SUPPLY
---------------------------------------------------------- Chapter 1:1
A growing percentage of the U.S. food supply is imported. The sheer
volume of these imports, along with the difficulty in ensuring that
they are safe, adds to the risk of foodborne illnesses.
As shown in table 1.1, the import share of some commonly consumed
foods is increasing. For example, in 1995, one-third of all fresh
fruits consumed in the United States were imported.
Table 1.1
Import Share of Selected Foods Consumed
in the United States, 1980-95
Percentage of total U.S. consumption
provided by imports
--------------------------------------
Percent
change,
Import item 1980 1985 1990 1995 1980-95
-------------------- -------- -------- -------- -------- --------
Fish and shellfish 45.3 53.8 56.3 55.3 22.1
Fresh fruits 24.2 28.0 30.7 33.3 37.6
Fresh vegetables 7.6 8.9 8.4 11.7 53.9
Tomatoes for 1.4 7.0 5.7 3.5 150.0
processing
Broccoli for 9.1 22.2 57.8 84.9 833.0
processing
----------------------------------------------------------------------
Source: U.S. Department of Agriculture, Economic Research Service.
Some imported foods pose a significant risk of foodborne illness.
They can introduce pathogens previously uncommon in the United
States, such as new strains of Salmonella and the Cyclospora
parasite. Imported foods may also contain pathogens, such as
hepatitis A, that cannot be easily detected until illness breaks out.
(App. I provides information on selected recent outbreaks of
foodborne illness related to imported foods.)
As the percentage of imported foods consumed in the United States
increases, the importance of ensuring that these foods are safe
increases as well. Ensuring food safety therefore cannot be achieved
by focusing on domestic products exclusively.
MULTIPLE AGENCIES ARE
RESPONSIBLE FOR ENSURING THE
SAFETY OF IMPORTED FOODS
---------------------------------------------------------- Chapter 1:2
Two federal agencies have the primary responsibility for ensuring the
safety of imported foods. The Food Safety and Inspection Service
(FSIS) in the U.S. Department of Agriculture (USDA) is responsible
for meat, poultry, and some egg products. The Food and Drug
Administration (FDA) in the Department of Health and Human Services
(HHS) is responsible for all other foods.
Under the Federal Meat Inspection Act, the Poultry Products
Inspection Act, and the Egg Products Inspection Act, as amended, FSIS
works to ensure that products moving in interstate and foreign
commerce are safe and wholesome, and correctly labeled and packaged.
In calendar year 1997, FSIS used about 84 staff years, costing an
estimated $3.2 million, to review about 118,000 import shipments and
to determine that exporting countries met U.S. food safety
requirements.
Under the Federal Food, Drug, and Cosmetics Act, as amended, FDA
works to ensure that domestic and imported food products are safe,
wholesome, and properly labeled.\3 In fiscal year 1997, FDA spent
approximately 463 staff years (inspectors, laboratory staff, and
support staff), at a cost of approximately $35.1 million, to ensure
the safety of about 2.7 million imported food shipments.
To assist these agencies, the U.S. Customs Service (Customs) in the
Department of the Treasury and HHS' Centers for Disease Control and
Prevention (CDC) provide a number of services, including referring
imported shipments for inspection and providing information on
outbreaks of foodborne illnesses. Customs is the first federal
agency to screen imported products, including food imports, when they
enter the United States. Enforcing laws for over 40 federal
agencies, Customs has, among other duties, the responsibility for
collecting revenues from importers and enforcing various customs and
related laws. Customs cooperates with FDA and FSIS in carrying out
their regulatory roles in food safety.
CDC is the federal agency primarily responsible for monitoring the
incidence of foodborne illness in the United States. CDC assists
state and local health departments and other federal agencies in
investigating outbreaks of foodborne illness, monitors information on
foodborne illnesses, and conducts research related to these
illnesses.
Since 1992, we have frequently reported on the fragmented and
inconsistent organization of food safety responsibilities in the
federal government.\4 These reviews have shown that inconsistencies
and differences between the agencies' approaches and enforcement
authorities undercut overall efforts to ensure a safe food supply.
To address this problem, we recommended the formation of a single
food agency. In the fiscal year 1998 appropriation act for USDA, the
Congress provided $420,000 for a study by the National Academy of
Sciences on the need to reorganize the federal food safety system.
--------------------
\3 FDA is also responsible for ensuring that certain other products
are safe. These products include drugs, cosmetics, medical devices,
and electronic products that emit radiation, such as television sets.
\4 Food Safety and Quality: Uniform, Risk-Based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992);
Food Safety: A Unified, Risk-Based System Needed to Enhance Food
Safety (GAO/T-RCED-94-71, Nov. 4, 1993); Food Safety: A Unified,
Risk-Based Food Safety System Needed (GAO/T-RCED-94-223, May 25,
1994); Food Safety: Changes Needed to Minimize Unsafe Chemicals in
Food (GAO/RCED-94-192, Sept. 26, 1994); and Food Safety:
Fundamental Changes Needed to Improve Food Safety (GAO/RCED-97-249R,
Sept. 9, 1997).
HOW IMPORT CONTROL PROCESSES
WORK
---------------------------------------------------------- Chapter 1:3
FDA and FSIS are the two agencies responsible for ensuring that the
imported shipments of food entering the United States are safe.
Their systems for inspecting, testing, and approving the release of
these food import shipments operate independently of each other.
FDA'S SYSTEM FOR ALLOWING
THE ENTRY OF IMPORTED FOODS
-------------------------------------------------------- Chapter 1:3.1
To ensure that FDA is notified of all imported food products under
its jurisdiction, an importer must file both an import notice and
certain shipping information and, for shipments valued over $1,250, a
bond to cover the goods for release with Customs within 5 days of the
shipment's arrival at a U.S. port of entry. The import documents or
electronic entry data identify the type of food product, the
importer, foreign manufacturer, and country of origin. The bond,
which covers potential duties, taxes, and penalties, may allow the
importer to retain control of the shipment until FDA decides to
inspect samples, test, or release it. If an importer fails to make
an import shipment available for FDA's inspection, fails to
recondition,\5 or fails to destroy or re-export the shipment, as
directed by FDA, Customs may collect penalties against all or part of
the bond value.
FDA relies on several sources of information to determine whether an
imported food shipment will be inspected or tested or can be released
into U.S. commerce. Among these sources are the following:
-- FDA's annual work plan. The annual work plan establishes, among
other activities, the number of inspections and tests that each
FDA district office is to conduct, which are derived from
guidance in specific food programs.\6 For example, the work plan
for fiscal year 1997 set inspection and testing activities for
10 imported food programs, such as imported low-acid/acidified
canned foods and imported seafood,\7 in four major project areas
related to food safety--Foodborne Biological Hazards; Pesticide
and Chemical Contaminants; Molecular Biology and Natural Toxins;
and Food and Color Additives.\8
-- FDA's Import Alert Retrieval System database. This database
contains a list of products that FDA automatically detains
because the exporter or the specific food products have shown a
history of violations in previous shipments.\9 FDA will not
approve the release into U.S. commerce of these automatically
detained shipments until the importer shows that the product is
not in violation, usually by providing the results of a private
laboratory analysis. FDA disseminates information on automatic
detentions to district offices through import alerts, which
identify problem commodities and/or exporters, foreign firms,
the country of origin, the reasons for detention, and the food
safety risk.
-- FDA's Low-Acid Canned Food database. This database contains
information on foreign processors of low-acid and acidified
canned foods registered with FDA. Foreign processors wishing to
export these foods to the United States must submit descriptions
of their canning processes to FDA before it will issue a
registration number for the firm and permit the entry of the
firm's shipments into U.S. commerce. The descriptions include
the manufacturing methods used to prevent spoilage and
contamination. FDA issues each foreign establishment a
registration number to help track the firm's registration and
processing records.
To assist FDA in reviewing all shipments, Customs' computer system
uses the information provided by the importer and FDA-developed
screening rates to determine which shipments to automatically release
into domestic commerce and which shipments to review further. FDA
sets the screening rates using several sources of information, such
as the annual work plan, compliance programs, type of product, and
past violations of products or shippers. Most shipments that are
believed to pose minimal safety risks, such as candy and dried pasta
products, are frequently released automatically because they have low
screening rates. FDA releases these shipments a few minutes after
the importer enters the information. Other shipments, such as some
seafood and low-acid canned foods, are less frequently or never
released automatically, because they pose greater potential risks.
Customs forwards information on products that are not automatically
released to FDA for further review, through FDA's automated screening
system, known as the Operational and Administrative System for Import
Support (OASIS). This system was pilot-tested in 1992 and installed
at all FDA's district offices by October 1997.\10 (Before OASIS was
developed, FDA manually tracked shipments through entry documents
submitted by importers to Customs.) Along with the electronic
information provided by the importer, FDA officials use the
information in OASIS and other sources as needed--such as the
databases with information on products to be automatically detained
and registration numbers for foreign firms--to determine which
samples of imported food shipments should be held for further action,
such as inspection and/or laboratory testing, and which can be
released without further review. FDA releases most shipments not
requiring further review within 3 hours after the importer enters the
information. FDA does not visually check or inspect these released
shipments.
FDA annually inspects or conducts laboratory analyses on a small
percentage--currently less than 2 percent--of all types of imported
food shipments. Inspections may occur at ports of entry and at
warehouses or other business establishments. If FDA decides to test
an imported food shipment, an FDA inspector collects a sample from
the shipment and sends it to a FDA laboratory for analysis. (FDA
maintains a record of all laboratory test results in its Laboratory
Management System database.) For samples found to comply with U.S.
standards, FDA notifies Customs and the importer that the shipment
can be released. For samples found to violate these standards, FDA
notifies Customs and the importer that the shipment has been refused
entry into U.S. commerce. Importers generally have three options
for handling shipments refused entry. If FDA concurs, importers can
recondition the shipment. Otherwise, they must either destroy or
re-export the shipment. Whatever option the importer chooses,
Customs officials are required to supervise proper disposition of the
refused shipment.
--------------------
\5 Importers can recondition imported products that do not meet U.S.
standards so that the products can enter the United States. Examples
of reconditioning include changing labels and fumigating raw
agricultural products.
\6 FDA refers to these programs as compliance programs.
\7 Low-acid canned foods are products like green beans, mushrooms,
and tuna fish. Acidified canned foods are low-acid foods to which
acid is added, such as pickles and marinated artichokes. Canned
products with low acidity are more prone to bacterial growth and
contamination.
\8 Technical Assistance is FDA's fifth major project area related to
food safety, but FDA did not identify inspection and testing
activities for programs in this area in 1997.
\9 FDA uses the formal term "detention without physical examination"
to identify those shipments that are automatically detained.
\10 FDA began developing an automated system as early as 1987. OASIS
succeeds an earlier version called the Import Support and Information
System.
FSIS' SYSTEM FOR ALLOWING
THE ENTRY OF IMPORTED FOODS
-------------------------------------------------------- Chapter 1:3.2
Before foreign firms can export meat and poultry to the United
States, FSIS must have determined that the exporting country has a
food safety system for these products that is equivalent to the U.S.
system. Unlike FDA, FSIS inspectors visually check every imported
shipment of foods under their jurisdiction for correct documentation,
transportation damage, and correct labeling at FSIS-approved import
inspection stations. FSIS conducts more intensive inspections and
tests on a portion of the imported shipments--about 20 percent in
1997--to verify the effectiveness of the foreign food safety system.
FSIS calls this process "reinspection" because the product has
already passed inspection by the exporting country's equivalent
inspection system.
Importers of FSIS-regulated products, like importers of FDA-regulated
products, must file an import notice and a bond with Customs within 5
days of the date that a shipment arrives at a port of entry to cover
their goods for release. Unlike FDA, however, importers must hold
shipments at FSIS-registered warehouses for FSIS' inspection until
these shipments are released into the domestic market or refused
entry.\11
FSIS inspectors enter the information provided by importers--such as
country of origin, foreign manufacturer, exporting country's health
certification, and type of product--into a centralized computer
system. This computer system, which was installed in 1979, is known
as the Automated Import Information System (AIIS). The system scans
the information it contains to determine if the country, plant, and
product are eligible for import into the United States and whether
the shipment will be allowed entry with only a visual check or be
subjected to more intensive inspections and tests.
The AIIS system uses computer-assigned screening procedures and
individual plants' performance histories to target shipments for more
intensive inspection and testing. Under the system, one violation on
the previous shipment of a particular product, such as boneless beef,
triggers more intensive inspection and testing for the same type of
product from the same foreign firm until FSIS has found at least 10
successive shipments that are free of violations and meet U.S.
standards. Violations that generate more intensive inspections
include food products that contain chemical residues or bone
fragments, have misidentified products, or have microbial
contamination. If the imported products do not meet U.S.
requirements, they are stamped "U.S. Refused Entry" and must be
exported, destroyed, or converted to animal food.\12 FSIS uses
information on refused shipments to plan inspections in foreign
countries.
--------------------
\11 FDA officials stated that they lack the authority to require that
shipments be held in a specific warehouse.
\12 Because of agreements with Canada, FSIS does not stamp refused
entry on each load of refused imported meat and poultry shipments
from Canada. Instead, FSIS notifies Canadian officials that the
shipment was refused entry and is being returned.
OBJECTIVES, SCOPE, AND
METHODOLOGY
---------------------------------------------------------- Chapter 1:4
Concerned over recent foodborne illnesses associated with imported
foods, the Chairman, Permanent Subcommittee on Investigations, Senate
Committee on Governmental Affairs, asked us to review federal
programs' efforts to ensure the safety of imported foods.
Specifically, this report discusses (1) the differences in the
agencies' authorities and approaches for ensuring the safety of
imported foods and (2) the agencies' efforts to target their
resources. In addition, the report discusses weaknesses in controls
over food imports.
Our work focused on the two principal federal agencies with
responsibility for ensuring the safety of imported foods--FDA and
FSIS. We also conducted work at Customs and CDC. We reviewed agency
and public information on foodborne illnesses and their relationship
to imported foods. We also spoke with FDA, FSIS, and CDC officials
about the link between foodborne illnesses with imported foods. We
reviewed information from USDA to determine the current level of food
imports into the United States, the share of imported foods in the
U.S. diet, and the costs associated with foodborne illnesses.
To examine the major authorities guiding the federal agencies
responsible for imported food safety, we reviewed the federal laws
and regulations governing imported foods. We also reviewed FDA's and
FSIS' documents describing their procedures for ensuring the safety
of imported foods, and we met with agency officials to discuss their
approach to inspecting imports. We also discussed with FDA officials
proposals to change FDA's statutory authority and to expand the
import inspection program. We reviewed various studies on the
effectiveness of different inspection approaches for ensuring the
safety of imported foods. We analyzed agency data on resources used,
import entries reviewed, and inspection actions taken.
To evaluate the approaches each agency uses to target imports for
examination, we reviewed agencies' documents describing their import
review procedures and the use of automated systems to screen imports.
We discussed these procedures and systems with FDA and FSIS
officials. We observed and analyzed the agencies' automated
screening processes, physical inspections, and sample collections at
FDA's and FSIS' field offices in California, Florida, New York, New
Jersey, Texas, and Washington State. We visited three FDA
laboratories to discuss and observe analysis procedures. We met with
Customs officials in Laredo, Texas; Los Angeles and San Francisco,
California; Miami, Florida; Port Elizabeth, New Jersey; and Seattle,
Washington; to discuss and observe how FDA and FSIS work with Customs
to handle the initial review of imported foods.
In the course of this review, we discussed and reviewed activities
related to controls over imported foods in the field offices we
visited. These activities included FDA's reliance on laboratory
analysis provided by importers, and agencies' practices and
procedures for (1) controlling imports before their release into
domestic commerce, (2) ensuring that refused entries are properly
disposed of, and (3) levying penalties against violators.
We performed our work from June 1997 through April 1998 in accordance
with generally accepted government auditing standards.
FDA'S LACK OF AUTHORITY FOR
EQUIVALENT INSPECTION SYSTEMS IN
EXPORTING COUNTRIES DIMINISHES ITS
ABILITY TO PROTECT CONSUMERS FROM
UNSAFE FOODS
============================================================ Chapter 2
FSIS shares the burden of ensuring the safety of the imported foods
it regulates with the exporting country, while FDA primarily relies
on inspections at the U.S. ports of entry to determine the safety of
the imported foods under its jurisdiction. Before it will allow a
country to export meat and poultry to the United States, FSIS is
required to determine that the exporting country has a food safety
inspection system for these products that is equivalent to the U.S.
system. By ensuring that countries exporting meat and poultry to the
United States have adopted practices that protect their products from
contamination, FSIS can devote its energies to verifying the efficacy
of these exporting countries' systems and thereby use its inspection
resources more efficiently. FDA does not have the authority to
impose such a requirement on foreign countries for fish, fruits,
vegetables, and the other foods for which it is responsible. Lacking
the authority to ensure that exporting countries are adopting safe
practices, FDA has to rely on labor-intensive inspections of imported
products at the port of entry as its primary line of defense against
the entry of unsafe foods. Because FDA is currently able to inspect
less than 2 percent of the foods imported under its jurisdiction
there is reason to question whether this approach adequately protects
U.S. consumers. Providing FDA with authority similar to FSIS' would
allow it to leverage its resources and provide greater assurance that
the imported foods it is responsible for are safe.
FSIS REQUIRES EQUIVALENT FOOD
SAFETY SYSTEMS IN EXPORTING
COUNTRIES, BUT FDA LACKS
SIMILAR AUTHORITY
---------------------------------------------------------- Chapter 2:1
Federal laws on meat and poultry imports require that the products
shipped to the United States meet U.S. standards for safety and
wholesomeness, and comply with U.S. labeling and packaging
requirements. Before a country can export meat and poultry to the
United States, it must demonstrate that it has a food inspection
system that is at least equivalent to the U.S. system. That is, the
exporting country's inspection system must include, among other
components, competent, qualified inspectors with the authority to
enforce national food safety laws and regulations; administrative and
technical support for these inspectors; and the implementation of
inspection, sanitation, quality, microbiological, and residues
standards equivalent to those applied to U.S. products.
In implementing this requirement, FSIS requires exporting countries
to apply for eligibility to export meat and poultry products to the
United States, to supply health certificates attesting to the safety
of the product with each exported item, and to submit exports for
inspection at the U.S. border to verify the effectiveness of the
foreign inspection system. FSIS staff visit foreign countries and
firms annually to verify the effectiveness of their systems. In
1997, for example, FSIS staff visited 30 of the 37 eligible exporting
countries to verify that the countries had changed their systems to
include new safety procedures required for all domestic and foreign
firms. These new procedures, called Hazard Analysis and Critical
Control Point (HACCP), build science-based food safety controls into
food production systems. Food firms incorporate controls into
processing steps, maintain records of compliance with controls, and
are subject to audits of their records to verify the program's
effectiveness. As of January 1, 1998, FSIS had determined that 37
countries have food inspection systems equivalent to the United
States' and are eligible to export meat and/or poultry products to
this country.\1 Products from countries not on the list of eligible
countries are automatically refused entry.
FDA does not have similar authority to accept only foods from
countries with equivalent safety inspection systems. The Federal
Food, Drug, and Cosmetics Act, which covers most food items other
than meat and poultry, requires imported products to comply with U.S.
standards for purity, wholesomeness, safety, and hygiene. It does
not, however, require the exporting countries to have inspection
systems equivalent to the U.S. system. Accordingly, FDA must, with
few exceptions, rely on inspections and tests of selected imported
foods at the U.S. port of entry as the only defense against unsafe
foods entering the United States. For a few products (infant formula
and low-acid and acidified canned foods), FDA may request that
foreign exporting firms grant FDA inspectors access to their plants,
but these inspectors actually conduct few foreign plant inspections.
In fiscal year 1996, FDA planned 90 such inspections but carried out
only 9. FDA planned 37 such inspections in fiscal year 1997,
carrying out 29.
Although FDA cannot currently require countries to demonstrate that
they have equivalent inspection systems before granting them
authority to export to the United States, it can negotiate voluntary
agreements with individual countries to establish equivalent
inspection systems. For example, in 1997, FDA began an intensified
effort to develop equivalency agreements, on a voluntary basis, with
the major seafood exporting countries, in response to new regulations
requiring all seafood producers selling to the U.S. market to use
new HACCP procedures. However, FDA officials said the agency has not
strongly pursued equivalency agreements on a broad scale because the
effort would require considerable resources to review foreign
countries' food safety systems. In addition, a single agreement with
each country might not be adequate because many countries have
multiple food safety programs for different food products or even for
different stages of preparation for the same product for export. For
example, one foreign agency may be responsible for the safety of
fresh produce, while another agency may be responsible for processed
produce.
Nonetheless, FDA believes that equivalency authority provides
significant benefits. In its 1997 draft Guidance on Equivalence
Criteria for Food, developed to implement HACCP requirements for
seafood processors, FDA stated,
where equivalence has been determined to exist . . . the work
of the foreign regulatory authority should serve to help ensure
the safety of imports for U.S. consumers. Since the foreign
inspection system will have been found to be equivalent to FDA's
inspection system, FDA will be able to rely on the results for
the foreign inspection system. . . . As equivalence is
achieved, and agreements are reached recognizing the achievement
of equivalence, trade is likely to flow more freely because of
the reduced need by importing countries to engage in
resource-intensive sampling and examination of products being
offered for entry from countries with equivalent systems. For
the United States, equivalency agreements will also mean that
FDA will be able to target the limited resources it has for
imports towards products from countries that have not been
determined to be equivalent. Thus, FDA will be able to use its
resources more efficiently and effectively.
In October 1997, as part of the administration's food safety
initiative, the President directed FDA to seek new authority to
require equivalency in food safety systems. In response, FDA
developed proposed legislation for new discretionary authority that
would allow the agency to prohibit imports of some foods, unless the
exporting country demonstrates that the food safety system and
conditions in the exporting country achieve the same level of
protection as food prepared and packed in the United States.
Legislation was introduced in the House of Representatives in
November 1997 and in the U.S. Senate in March 1998, and is under
consideration.\2 The legislation would allow FDA to determine that an
imported food is adulterated, and thus cannot be imported, if the
foreign system, conditions, or measures for preparing or packing the
food product are not equivalent to the level of protection required
for similar foods produced in the United States.
--------------------
\1 Since Jan. 1, 1998, FSIS has suspended Paraguay from exporting
because FSIS found that the country had not implemented required
pathogen reduction tests and had contaminated products in foreign
plants. FSIS is considering action to withdraw several other
countries from the list of eligible exporting countries because they
do not comply with new regulations for testing for E. coli and
implementing sanitary operating procedures.
\2 H.R. 3052, the "Safety of Imported Food Act of 1997," and S.
1707, the "Safety of Imported Food Act of 1998." No action had been
taken as of Apr. 10, 1998.
EQUIVALENCY AUTHORITY ALLOWS
FOR MORE EFFECTIVE USE OF
RESOURCES TO ENSURE SAFETY OF
IMPORTED FOODS
---------------------------------------------------------- Chapter 2:2
FSIS uses its equivalency authority to shift the primary
responsibility for food safety to the exporting country. Rather than
focusing on resource-intensive port-of-entry inspections, FSIS
emphasizes reviews of exporting countries' compliance with U.S.
requirements. In contrast, FDA relies on port-of-entry inspections
to ensure that imported foods are safe. This approach does little to
verify the safety of all imported foods because it does not account
for the conditions under which the products were processed and
packed. The efficacy of port-of-entry inspections therefore depends
on inspecting an adequate sample of imports, an objective FDA has not
been able to meet, particularly as import volumes have increased. In
addition, inspections of imported foods may be insufficient to
determine whether contamination has occurred. For example, both
visual inspections and laboratory tests are inadequate to detect
Cyclospora, according to CDC.
EQUIVALENCY ENABLES FSIS TO
LEVERAGE ITS RESOURCES BY
SHARING RESPONSIBILITY WITH
THE EXPORTING COUNTRIES
-------------------------------------------------------- Chapter 2:2.1
By requiring exporting countries to assume responsibility for the
safety of meat and poultry products sent to the United States, FSIS
can extend the coverage and enhance the effectiveness of its
inspection resources. In 1997, FSIS had about 12 staff involved in
reviewing the continuing eligibility of foreign countries to export
their meat and poultry products to the United States, through
document reviews and regular inspections in those countries. It also
deployed about 75 inspectors to (1) ensure that each imported
shipment had a health certificate from the exporting country, (2)
visually check every shipment for transportation damage and accurate
shipping labels, and (3) conduct intensive inspections and tests on a
sample of products as a way of verifying the performance of the
exporting country's system. This approach allows FSIS to transfer
the primary food safety responsibility to the exporting country.
FSIS considers the eligible foreign country's inspection system--not
its own inspection at the port of entry--to be the primary control
for ensuring that imported meat and poultry products meet U.S.
standards. If a country fails to maintain an equivalent safety
system, FSIS can suspend the eligibility of that country to export
FSIS-regulated products to the United States.
FDA'S PORT-OF-ENTRY
INSPECTIONS PROVIDE
CONSUMERS LIMITED PROTECTION
AGAINST UNSAFE IMPORTS
-------------------------------------------------------- Chapter 2:2.2
FDA's reliance on inspecting imported foods at the U.S. port of
entry provides weak assurance that the foods it allows to enter the
United States are safe. According to the United Nation's Food and
Agriculture Organization, testing products at the port of entry
involves a concentration of inspection resources on the imported
product itself and is an attempt to compensate for a lack of
knowledge about the processing, hygiene, and sanitation practices of
the producer. In addition, FDA's draft guidance on equivalency
criteria states that, by itself, end-product inspection and testing
at the port of entry cannot be relied upon to provide adequate
protection because assurance that food will not present unacceptable
risks requires effective processing controls that are periodically
inspected and verified by a regulatory authority.
Similarly, a 1991 report by the Advisory Committee on the Food and
Drug Administration called point-of-entry inspections an
anachronism.\3 The process of inspecting a final product to determine
if it conforms to standards and of rejecting those that do not has
been "totally discredited," according to the committee, as a means of
ensuring manufacturing quality or regulatory compliance for domestic
products.
Likewise, in 1994, we reported that reliance on end-product testing
was an ineffective, resource-intensive, and statistically invalid
approach to ensuring that imported foods are not contaminated with
unsafe levels of chemicals.\4 We recommended that the Congress change
the federal government's role in ensuring food safety by moving away
from end-product testing to an approach preventing contamination from
occurring, such as the use of HACCP in production processes. In
addition, we suggested the Congress consider requiring that all
imported foods be produced under equivalent food safety systems.
HACCP is now required for some products, such as seafood, and the
Congress is considering legislation to provide FDA with equivalency
authority.
The capabilities of FDA's inspection approach to protect consumers
from unsafe products has been further called into question by the
agency's inability to keep pace with rising import levels. Between
1992 and 1997, the number of imported food entries more than doubled,
from 1.1 million to 2.7 million. As workloads increased, resources
devoted to inspecting imported foods declined by 22 percent, from 328
staff years for inspectors in 1992 to 257 staff years for inspectors
in 1997; thus, the average number of annual food shipments each
inspector was responsible for increased from about 3,350 to about
10,500. As a result of these and other factors, FDA's inspection
coverage of imported food entries has fallen from an estimated 8
percent of food entries in fiscal year 1992 to 1.7 percent in fiscal
year 1997. Of the 2.7 million total food entries in 1997, 56 percent
were released after FDA's automated screening system reviewed the
import information, 42.3 percent were released after an inspector
reviewed electronic information or import documents, and the
remaining 1.7 percent were held for inspection. Of the 1.7 percent
held for inspection (46,295 entries), FDA conducted laboratory
analyses on 16,048 entries, or 0.6 percent of the total number of
food entries. (See table 2.1.)
Table 2.1
Disposition of Import Entries That
Required FDA's Review, Fiscal Year 1997
Number of
Disposition entries Percentage
------------------------------------------ ------------ ------------
Released automatically by Customs/FDA 1,519,233 56.0
electronic screening
Released after FDA electronic or paperwork 1,145,355 42.3
review
FDA inspections conducted 46,295 1.7
======================================================================
Total food entries requiring FDA's review 2,710,883 100.0
----------------------------------------------------------------------
Source: FDA.
In contrast to the growing demands placed on FDA's inspection
resources, FSIS' import inspectors have a more manageable and stable
inspection burden. The number of import entries per FSIS inspector
rose from about 1,236 in calendar year 1992 to about 1,645 in 1997.
In addition to visually checking every shipment, FSIS performed more
intensive inspections on about 20.2 percent of the 118,000 entries in
1997, somewhat less than its rate of 26.9 percent in 1992. FSIS also
visited 30 countries and conducted 336 foreign plant inspections in
1997 as part of its ongoing equivalency reviews.
--------------------
\3 Final Report of the Advisory Committee on the Food and Drug
Administration, Advisory Committee on the Food and Drug
Administration, U.S. Department of Health and Human Services, May
1991.
\4 Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food
(GAO/RCED-94-192, Sept. 26, 1994).
CONCLUSIONS
---------------------------------------------------------- Chapter 2:3
Given its lack of authority to require equivalency in foreign food
safety systems, FDA relies primarily on port-of-entry inspections and
tests to ensure the safety of imported foods. Because such
port-of-entry inspection and testing has been widely discredited as
an effective means for ensuring safety, FDA cannot realistically
ensure that unsafe foods are kept out of U.S. commerce. Even if FDA
could inspect more shipments at the ports of entry than it currently
does, such an approach would still lack assurance that imported foods
are picked, processed, and packed under sanitary conditions. An
equivalency requirement would allow FDA to shift the primary burden
of ensuring safety to the exporting country while achieving better
assurance that food production and processing is safe and sanitary.
RECOMMENDATION TO THE CONGRESS
---------------------------------------------------------- Chapter 2:4
To strengthen FDA's ability to ensure the safety of imported foods,
we recommend that the Congress require all food eligible for
importation to the United States, not just meat and poultry, be
produced under equivalent food safety systems.
AGENCY COMMENTS AND OUR
RESPONSE
---------------------------------------------------------- Chapter 2:5
In commenting on a draft of this report, FDA agreed that it needs
equivalency authority to control the safety of imported foods, but it
did not agree that equivalence should be a requirement for the entry
of imported foods. FDA believes the authority should be
discretionary, not mandatory, so that equivalency could be applied
where it is most appropriate without disrupting trade. We believe
that equivalency should be mandatory for all imported foods and could
be implemented in a manner that would not unnecessarily or unfairly
disrupt trade. Mandatory authority to require equivalency would
address weaknesses in FDA's port-of-entry inspection approach, enable
FDA to leverage its staff resources by sharing the responsibility for
food safety with the exporting countries, and compel FDA to take a
proactive approach in preventing food safety problems instead of
requiring equivalency after problems are identified. The Congress
could provide reasonable time frames that would allow equivalency to
be implemented over a number of years.
FDA and CDC provided technical comments that we incorporated where
appropriate.
AGENCIES HAVE NOT EFFECTIVELY
TARGETED THEIR RESOURCES ON
IMPORTED FOODS POSING GREATER
RISKS
============================================================ Chapter 3
FSIS and FDA are not deploying their inspection resources to maximum
advantage. With respect to FSIS, it is misdirecting some of its
resources by targeting its inspections on the basis of all past
violations--most of which are less concerned with food safety, such
as missing shipping labels--rather than by focusing on violations
directly related to food safety, such as contamination and
decomposition. As a result, FSIS' resources are not being focused on
imported foods posing the greater safety risk.
With respect to FDA, its system for identifying shipments for
inspection is hampered by work plans that do not set clear priorities
for inspectors in making selection decisions, a failure to make
relevant health risk data readily available to its inspectors to help
them select shipments to inspect, and a failure to ensure that
importer-provided information on incoming shipments is accurate.
Nationwide, FDA also cannot be assured that its limited resources are
consistently targeting shipments posing the greater health risks.
FSIS DOES NOT USE LABORATORY
RESULTS TO FOCUS ITS
INSPECTIONS ON SHIPMENTS POSING
FOOD SAFETY RISKS
---------------------------------------------------------- Chapter 3:1
FSIS' Automated Import Information System (AIIS) targets shipments
for more intensive inspections and testing mainly on the basis of the
violation history associated with the foreign firm producing the
imported product. This overall violation history may be misleading,
however, because AIIS treats all violations equally, except for
transportation damage, in determining how much inspection attention
will be provided to an importing firm's products.\1 As a result,
violations not usually posing a direct health risk to consumers--such
as a missing shipping label, incorrect weight, and misidentified
product--could trigger a requirement for the agency to inspect every
shipment from a foreign firm until the firm reestablished a good
track record. In 1996, about 86 percent of the refused shipments,
excluding those refused for transportation damage, were not directly
related to health risks.\2 These violations triggered a series of
inspections on subsequent shipments of the same product from the same
exporting firm until at least 10 consecutive shipments were found to
be in compliance. When limited resources are targeted in this
fashion, fewer resources are available for products posing the
greater health risk.
FSIS stores the test results associated with previous inspections of
imported foods--data that would help identify shipments with the
highest health risks--in AIIS, its automated screening system.
However, the system does not use this information to identify
patterns of violations, such as firms or countries with repeated
problems, that are directly related to food safety. FSIS could
further improve its automated screening system if it developed
information on patterns of violations, which would allow it to
determine whether Salmonella contamination, for example, was a
recurrent problem in a particular country or exported product and
increase its inspection frequencies for such shipments. In addition,
FSIS could work with the exporting country to determine the extent of
the problem and to take actions to correct it.
--------------------
\1 Violations resulting from transportation damage do not trigger an
automatic requirement for further inspections because they are not
attributed to the exporting firm.
\2 Refusals with direct health risks include excessive residues;
microbiological contamination; unsound condition, such as visual
deterioration or odor; and defects caused by disease.
SEVERAL KEY PROBLEMS WEAKEN
FDA'S SYSTEM FOR IDENTIFYING
SHIPMENTS TO TARGET FOR
INSPECTIONS
---------------------------------------------------------- Chapter 3:2
FDA's system for identifying shipments that should be targeted for
inspection is undermined by problems in three key areas. First,
FDA's annual work plan, which contains the number of inspections and
tests each FDA district is to conduct, is not realistic. FDA
inspectors attempt to use these numbers to guide their decisions on
which products to inspect and test. Second, FDA's inspectors cannot
readily obtain available health risk data that would help them choose
the shipments likely to pose health risks. Third, FDA does not act
to ensure that importer-provided information, which its screening
system relies on to identify a shipment's contents, is correct. As a
result of these problems, FDA's inspectors at ports of entry, working
under significant time pressures to move shipments quickly into
domestic commerce, make subjective decisions that may not target the
riskiest shipments.
FDA'S ANNUAL WORK PLAN IS
NOT USEFUL IN MAKING
SELECTION DECISIONS IN
DISTRICT OFFICES
-------------------------------------------------------- Chapter 3:2.1
FDA's annual work plan sets the number of activities, such as the
number of inspections and tests, each FDA district is to conduct for
the 10 specific food programs that cover imports. These programs,
such as seafood, imported low-acid canned food, or imported cheese,
are consolidated under the four major project areas related to food
safety--Foodborne Biological Hazards, Pesticides and Chemical
Contaminants, Molecular Biology and Natural Toxins, and Food Color
and Additives. For example, for FDA's Seattle District, the fiscal
year 1997 work plan called for 165 inspections and 583 laboratory
tests of imported seafood products. For imported seafood products
nationwide, the work plan called for 2,500 inspections and 9,432
laboratory tests.
Each day, FDA inspectors must decide which shipments of food imports
to inspect. The inspectors at the locations we visited typically
attempt to select shipments on the basis of the work plan's targets.
However, regional and district FDA officials told us that the numbers
for inspections and tests contained in the work plan were not
realistic because they did not take into account the time required to
investigate emergencies and consumer complaints, which invariably
occur. In 1997, for example, FDA spent 6,274 hours investigating the
outbreaks associated with Guatemalan raspberries--time not accounted
for in the work plan. As a result, FDA inspectors are not able to
complete the work plan and compliance program activities and
therefore rely on their judgment when determining what to inspect and
test.
Meeting the annual work plan targets is a problem nationwide. Table
3.1 shows the degree to which FDA inspectors fell short of completing
the number of planned inspections and tests for fiscal years 1996 and
1997 in the four areas related to food safety. For example, in
fiscal year 1997, 23,000 inspections and 19,432 laboratory analyses
were planned for foodborne biological hazards. However, FDA was only
able to conduct 11,587 inspections and 12,874 analyses. As a result,
the inspections and tests conducted varied significantly among
project areas.
Table 3.1
Planned and Completed FDA Import
Inspection Activities, Fiscal Years 1996
and 1997
Fiscal year 1996 Fiscal year 1997
------------------------------------ ------------------------------------
Inspection Percent Percent
activities\a Planned Completed completed Planned Completed completed
------------- ---------- ---------- ------------ ---------- ---------- ------------
Foodborne Biological Hazards Project
-----------------------------------------------------------------------------------------
Foreign plant 90 9 7 37 29 67
inspections
Import 26,250 11,983 46 23,000 11,587 50
inspections
conducted
Import 19,432 13,710 71 19,432 12,874 66
samples
analyzed
Pesticides and Chemicals Contaminants Project
-----------------------------------------------------------------------------------------
Import 8,794 6,228 71 8,294 5,675 68
samples
analyzed
Molecular Biology and Natural Toxins Project
-----------------------------------------------------------------------------------------
Import 555 386 70 1,380 564 41
samples
analyzed
Food and Color Additives Project
-----------------------------------------------------------------------------------------
Import 2,395 1,816 76 2,353 1,816 77
samples
analyzed
-----------------------------------------------------------------------------------------
\a A fifth area related to food safety, Technical Assistance, did not
have planned inspection or testing activities for fiscal year 1997.
Source: FDA.
Inspectors use their own judgment in making decisions on inspections
and laboratory analyses. We found that this judgment is highly
subjective. For example, one inspector told us he believed one
country did not have sanitary facilities and therefore assumed that
all food products imported from that country are contaminated with
filth. During our visit, he routinely selected samples of food from
that country for filth tests, although the laboratory staff told us
filth tests were not a high priority and, in fact, they sometimes did
not conduct the tests because they already had a backlog of tests to
conduct. Therefore, to the extent that the laboratory analyses were
not conducted, the inspector wasted time collecting the samples.
FDA INSPECTORS CANNOT
READILY ACCESS RELEVANT
HEALTH RISK INFORMATION
-------------------------------------------------------- Chapter 3:2.2
FDA retains information in a number of databases on the health risks
presented by certain foods from a particular exporting country and/or
an exporting company. These data include the results of the
laboratory tests that FDA conducts on imported foods and lists of
foreign products to be detained because they have a history of
violations. In addition, FDA maintains lists of foreign plants that
have registered with FDA their processes for producing low-acid
canned foods and acidified canned foods. If these products have not
been produced with a registered process, they are banned from entry.
With respect to laboratory tests, FDA has not integrated its
laboratory database with its OASIS system, the system used to screen
imports. Therefore, inspectors do not have available the results of
prior laboratory tests when considering possible actions to inspect
imported products. FDA plans to integrate the laboratory database
with OASIS in fiscal year 1998 to make better use of staff resources
in targeting defective and dangerous products. Furthermore, FDA
inspectors do not have ready access to some useful data in OASIS when
deciding which products to inspect. For example, inspectors can
obtain information on prior violations by foreign plants or
countries, but the process for doing so can be cumbersome and
time-consuming. To obtain these data, inspectors have to close their
OASIS database and open another database. We observed two inspectors
going through this process--which took 3 to 10 minutes per
shipment--at a time when one of these inspectors had to process as
many as 200 shipments per day. Not all inspectors will change
databases to look for this information. Instead, inspectors told us
they often rely on their memory of the information in the database or
notes. Similarly, to obtain information on foreign registrations,
inspectors have to close OASIS and open the registration database.
Again, some inspectors find the process time-consuming and
accordingly often choose to rely on memory. Because inspectors have
these difficulties in obtaining needed data on health-related risks
and are under time pressures, they may make decisions to select
samples on the basis of incomplete information.
FDA has recognized the problems associated with difficulties in
obtaining health risk data. In a 1993 hearing on food imports, FDA's
Director of the New York District Office stated that FDA tries to
funnel its limited inspection resources towards the imports that pose
the greater risk and have the greatest likelihood of being
adulterated or misbranded.\3
He added that including information, such as the data discussed
above, in OASIS would be very useful in helping FDA inspectors make
daily decisions on which import shipments to inspect and test. Two
years later, in a 1995 FDA internal review, FDA's automated system
was criticized for not providing inspectors with a means for
accessing other FDA databases, such as the FDA Import Alert Retrieval
System database.\4 The review said that such access would improve
inspectors' efficiency in identifying shipments that need to be
detained. According to FDA officials, the agency received money to
make these improvements in the screening system in fiscal year 1998
and will begin integrating the databases (Laboratory Management
System, FDA Import Alert Retrieval System, and Low-Acid Canned Food
database) with OASIS this year.
--------------------
\3 FDA's Regulation of Food Imports, Hearings before the Subcommittee
on Oversight and Investigations, Committee on Energy and Commerce,
House of Representatives, June 16, 1993 (Serial no. 103-28).
\4 Review of the Import Support and Information System (ISIS), FDA
System Design Review Committee, June 21, 1995.
FDA DOES NOT ENSURE THE
ACCURACY OF
IMPORTER-PROVIDED SHIPPING
INFORMATION
-------------------------------------------------------- Chapter 3:2.3
To facilitate the entry of imported foods under FDA's jurisdiction,
importers enter data electronically on incoming shipments into OASIS
after demonstrating competency with the system. Electronic filers
that do not routinely have to provide actual shipping documents to
FDA are called paperless filers. FDA inspectors rely on this
electronic information in making their selections for inspections and
laboratory analyses.
To ensure the accuracy of this information, FDA periodically requests
the paperless filers to provide shipping documents on a sample of
entries, and FDA then compares these documents against the
electronically provided information for errors. Errors can include
incorrectly identifying a product as exempt from FDA's regulation,
entering the wrong FDA product code, or listing the wrong country of
origin. Electronic filers exceeding the allowed 10-percent error
rate may be removed from paperless status.
However, FDA records show that no corrective actions have been taken
to remove even the most error-prone paperless filers from paperless
status. According to a January 1998 FDA survey, 306, or 14.5
percent, of the 2,114 paperless filers audited had errors rates of 10
percent or greater, but none of these filers were removed from
paperless status. For example, the paperless filer error rates for
the New York District were 10 percent or more in 133 of the 251
audits conducted, but no electronic filers were removed from
paperless status. Similarly, as of November 1997, none of the 16
electronic filers at the Miami field location with error rates of 10
percent or greater were removed from paperless filer status. In
fact, the filer with the highest error rate--20 percent--has remained
in paperless status without any follow-up audits since April 1996.
FDA officials at three locations we visited believed the error rates
were high primarily because the product codes are complex for the
importers to learn and use. In one case, for example, we found that
an importer had incorrectly entered the code for spaghetti, a form of
pasta, instead of cappelletti, another form of pasta.
The failure to take corrective actions to remove filers from
paperless status, as found in the January 1998 FDA survey, could
affect decisions on selections for investigating food safety risks.
Importers aware of FDA's inaction could evade FDA's inspections by
incorrectly describing the contents of a shipment. For example, an
FDA inspector at one port of entry said that, while most errors are
accidental, he has encountered problems with importers who appeared
to deliberately avoid FDA's inspections by using the wrong product
code for swordfish, which is automatically held until the importer
provides laboratory test results demonstrating that the product
complies with U.S. standards. By entering a code for another type
of fish, the importers hope that the on-screen review will not detect
a discrepancy and the shipment will not be selected for inspection.
Following an FDA investigation in 1993, an importer was prosecuted
for deliberately misrepresenting imported foods. The importer was
found guilty on 138 counts, mostly of misrepresenting the source of
seafood in an attempt to avoid FDA's automatic detention.
FDA inspectors told us that when they encounter entry errors during
evaluations, they inform the importer of the errors and offer help on
entering the correct information. Even when these inspectors
occasionally find incorrect entries that appear to be deliberate
misrepresentations, they work with the importer to correct the entry
problems and, in most cases, do not investigate the suspect filers
further. They said that they view their role as teachers, not
investigators.
CONCLUSIONS
---------------------------------------------------------- Chapter 3:3
Given the small fraction of import entries that FDA and FSIS can
inspect, the agencies need to make the best use of all the
information available to help select the right shipments to review.
Both agencies have information to identify relationships between
foodborne pathogens and specific food products, which would be a good
indicator of the food safety risks associated with import shipments,
but neither agency has used the information effectively or
efficiently. As a result, FSIS is using its limited inspection
resources to conduct inspections and tests triggered by violations
that may not be related to safety. In addition, FDA's limited
inspection resources may not be targeted to the riskiest shipments
for a number of reasons. Reliance by FDA field offices on numerical
inspection targets that are not closely linked to the risk-based
priorities identified in the compliance programs impedes inspectors'
effectiveness in selecting imported food shipments for inspections
and tests, key information on firms and products is not easily
accessible and thus may be overlooked, and a shipment's contents may
be misrepresented.
RECOMMENDATIONS
---------------------------------------------------------- Chapter 3:4
To help FSIS better identify the risks associated with specific foods
and thereby further improve the Automated Import Information System's
usefulness in selecting high-risk products to inspect, we recommend
that the Secretary of Agriculture direct the Administrator, FSIS, to
modify the Automated Import Information System so that the system can
identify patterns between laboratory test results and specific foods,
foreign firms, and exporting countries.
To provide more accurate and accessible information to FDA and thus
minimize inconsistencies in inspectors' subjective decisions, we
recommend that the Secretary of Health and Human Services direct the
Commissioner, FDA, to
-- clarify and emphasize the guidance inspectors should use when
making decisions on which shipments to inspect and test;
-- modify the Operational and Administrative System for Import
Support system so that (1) it automatically reviews the Import
Alert and Low-Acid Canned Food databases and recommends
appropriate actions to inspectors and (2) inspectors can
consider previous laboratory test results, which are stored in
the Laboratory Management System database, in choosing shipments
for inspections and tests; and
-- ensure that the field offices are taking appropriate corrective
action, when warranted, against importers that repeatedly enter
incorrect shipping information into the Operational and
Administrative System for Import Support database.
AGENCY COMMENTS AND OUR
RESPONSE
---------------------------------------------------------- Chapter 3:5
In commenting on a draft of this report, FSIS agreed with our
recommendation. The agency stated that it will be evaluating its
port-of-entry inspection procedures and its automated systems, and
will consider our recommendation during this evaluation.
FDA agreed with our recommendation to link three databases-- the
Import Alert database, the Low-Acid Canned Food database, and the
laboratory database-- to its automated import screening system, the
Operational and Administrative System for Import Support (OASIS), for
use by inspectors when choosing shipments for inspections and tests.
FDA stated that the automatic review of the Import Alert database and
the Low-Acid Canned Food database is under development. The agency
stated further that it is developing software that will allow
inspectors to review previous laboratory test results through OASIS.
FDA expects all these improvements will be completed and operating by
the end of fiscal year 1998. FDA also agreed with our recommendation
to ensure that district offices are taking appropriate corrective
action against importers that repeatedly enter incorrect shipping
information in OASIS.
FDA also generally agreed with the report's recommendation regarding
its import screening system. FDA described planned actions to
improve the efficiency of its automated import screening system and
to take appropriate corrective actions in its electronic filer
program. FDA did not agree with our characterization of its system
for communicating inspection priorities to its inspectors or the
associated recommendation in our draft report to improve this system.
Specifically, FDA said that its annual work plan and compliance
programs provide sufficient guidance to inspectors to help them make
decisions about which shipments to inspect. We continue to believe
that the priority-setting guidance provided to inspectors, even as it
is described in FDA's comments, is confusing and inconsistent. As a
result, inspectors may not be selecting shipments to inspect that
pose the greater food safety risk to consumers. We have, however,
modified our recommendation to better reflect the nature of the
problem and to give FDA more flexibility to address it.
We also incorporated technical comments from FSIS and FDA where
appropriate.
WEAKNESSES IN CONTROLS OVER FOOD
IMPORTS ENABLE ENTRY OF UNSAFE
PRODUCTS
============================================================ Chapter 4
In addition to the problems associated with its automated system for
selecting food shipments for inspection, FDA has several weaknesses
in its controls over imported products that have enabled some
importers or their representatives to sell unsafe foods in the United
States. First, FDA's system for automatically detaining suspicious
products pending testing to confirm their safety may be easily
subverted because FDA does not maintain control over the testing
process. By allowing importers to choose their own laboratories to
select samples and perform tests, FDA opens itself to the possibility
of approving the entry of unsafe products on the basis of falsified
test results. Second, FDA does not maintain control over products
before releasing them into U.S. commerce. As a result, some
importers have sent products to grocery stores before FDA has
approved their release, and others have not returned and properly
disposed of products that FDA has conditionally released but called
back after testing showed them to be contaminated. In this
connection, importers that violate FDA's and Customs' controls are
frequently not penalized to deter such actions.
SOME IMPORTERS INTRODUCE
POTENTIALLY UNSAFE FOODS INTO
U.S. COMMERCE
---------------------------------------------------------- Chapter 4:1
FDA's system for controlling the importation of unsafe foods has a
history of circumvention by certain unscrupulous importers. For
example, we reported in 1992 that about 10 importers had repeatedly
distributed pesticide-adulterated shipments in disregard of FDA
orders; in total, these importers distributed 73 shipments known to
have been adulterated.\1 In all, about a third of the adulterated
shipments that were identified reached the market.
A 1997 investigation by Customs confirmed that importers continue to
evade import controls. Recognizing problems in controlling imported
shipments, Customs launched a special operation at the port of San
Francisco in 1997, known as Operation Bad Apple. Customs officials
told us that of the shipments FDA ordered returned to Customs for
destruction or reexport, 40 percent were never redelivered, and for
half of those that were redelivered, other products had been
substituted for the original contaminated products. Thus, 70 percent
of the shipments ordered returned because they were unsafe presumably
entered into commerce, contrary to FDA's orders. FDA and Customs
officials developed a joint task force in November 1997, called CLEAN
(Closing Loopholes to Ensure Acceptable Nutrition), to address the
problems identified in Operation Bad Apple.
--------------------
\1 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
FDA'S SYSTEM FOR DETAINING
QUESTIONABLE FOOD SHIPMENTS CAN
BE EASILY EVADED
---------------------------------------------------------- Chapter 4:2
FDA's automatic detention system is subject to evasion by
unscrupulous importers. FDA automatically detains imported foods
that, on the basis of prior violations, have a high potential for
being contaminated. In these cases, rather than destroying or
exporting the products, importers have the option of presenting the
results of a private laboratory test to show that the detained
products meet U.S. standards. However, FDA generally does not
control the selection of the samples tested and cannot restrict the
choice of the laboratories used to conduct the tests. According to
FDA, the agency lacks explicit authority to require the use of
specific laboratories importers can use. As such, importers can
choose the laboratory, which selects the sample and conducts the
analysis. While FDA expects these laboratories to comply with the
agency's written guidance for collecting samples and performing
tests, the agency generally does not control the selection of samples
or witness laboratory analyses. This approach exposes FDA to the
possibility that it will accept falsified test results or results
from tests using improperly selected samples as a basis for releasing
products into domestic commerce.
In fiscal year 1997, FDA detained 7,874 import shipments
automatically. While FDA does not keep specific records, FDA
officials said most shipments detained automatically are released
after importers present their private laboratory results.
Customs and FDA officials are concerned about monitoring the accuracy
of private laboratories chosen by importers in selecting and
analyzing samples of imported foods that are on automatic detention
status. Some Customs inspectors voiced concerns that some
unscrupulous importers, to ensure their products meet U.S.
requirements, share shipments that have already been tested and
proven to be in compliance for sampling purposes--a concept referred
to as "banking." FDA inspectors were also concerned about the
uncontrolled sampling and testing of imported foods under FDA's
jurisdiction. To verify the accuracy of tests performed by private
laboratories, FDA laboratories occasionally select samples from the
same shipments and perform identical tests. Officials at two field
locations we visited told us that the FDA laboratories, in performing
these tests, discovered violations that the private laboratory tests
did not identify.
FDA is further increasing its reliance on the use of private
laboratories for analyzing imported foods normally tested by FDA
laboratories. Specifically, according to FDA's Procedures Manual,
the increased scrutiny of import commodities and limitations on FDA
resources are likely; therefore, FDA will expedite its enforcement
efforts by using scientifically sound data provided by private
laboratories to determine if products should be allowed entry. In
this regard, FDA is testing a new process to allow seafood importers
the option of having a private laboratory select and analyze seafood
samples for FDA's routine review of imported seafood. Under a pilot
program at the Los Angeles District Office, if FDA selects the
shipment for laboratory analysis, it will identify the product lots
and sample sizes, and specify the type of analysis to be conducted,
and the importer will choose the laboratory that will collect the
samples and conduct the analysis.
While FDA is generally increasing its reliance on the test results of
samples selected and analyzed by private laboratories, it has
recognized that the practice of allowing importers to select their
own product samples for testing is questionable. In this regard,
importers of Guatemalan snow peas must now use third-party companies
to select the laboratory samples because FDA test results have
differed historically from the results of the importers' selected
laboratory. In response to an internal report on the use of private
laboratories, FDA approved new guidelines in March 1998 on the review
of test results prepared by private laboratories. According to the
guidelines, sample selection and laboratory analysis should be
conducted by an independent party.\2
--------------------
\2 Private Laboratory Grassroots Meetings, 1996, A Final Report and
Action Plan, sponsored by Division of Field Science, Office of
Regional Operations, Office of Regulatory Affairs, U.S. Food and
Drug Administration (undated).
FDA AND CUSTOMS MAINTAIN
INSUFFICIENT CONTROLS OVER
KNOWN AND POTENTIALLY UNSAFE
PRODUCTS
---------------------------------------------------------- Chapter 4:3
Imported foods under FDA's jurisdiction, including foods that are of
concern or are proven to be adulterated, are sold in domestic
commerce before FDA has released them. This occurs because (1)
importers either sell imported products before FDA has had a chance
to inspect them or do not properly dispose of products that FDA has
found to violate U.S. standards and (2) penalties against importers
have not effectively deterred such actions.
IMPORTED FOODS NOT
CONTROLLED PRIOR TO RELEASE
-------------------------------------------------------- Chapter 4:3.1
FDA-regulated foods are not controlled prior to inspection and
release. Under the Federal Food, Drug, and Cosmetics Act, importers
of FDA-regulated foods generally retain possession of the imported
food shipments until FDA releases them and must make the shipments
available for FDA's inspection if requested. In some cases,
particularly for perishable items, FDA will select samples for
testing and allow the shipments to continue in domestic transit--on
the condition that the shipment be returned if FDA finds the shipment
to be adulterated and refuses entry. If importers of foods that FDA
has refused entry cannot recondition the products to bring them into
compliance with requirements, they have 90 days to (1) destroy the
products or (2) reexport the products. The Customs Service is
required to witness or attest to the fact that the refused shipment
was disposed of properly, but FDA does not stamp "refused entry" on
shipments found to violate safety standards, and it generally does
not notify the destination country when such shipments are being
reexported. According to FDA officials, FDA does not stamp refused
shipments because it lacks the statutory authority to do so.
At the ports we visited, imported food shipments under FDA's
jurisdiction often entered U.S. commerce before being delivered to
FDA for inspection or were not properly disposed of when refused
entry. For example, in Operation Bad Apple, which lasted 3 weeks,
Customs officials identified 23 weaknesses in the controls over
FDA-regulated imported foods. In this operation, Customs officials
cited the following examples to illustrate these weaknesses.
-- Substituting cargo that was en route to a holding area. On a
shipment of frozen shrimp, Customs alleged that the importer
removed a portion of the shipment that had thawed during
transport before making the shipment available for FDA's
inspection. If the thawed shrimp had not been removed, FDA
would have refused entry for the entire shipment because the
thawing indicated that the proper temperature controls were not
maintained during transport, and thus the entire shipment may be
contaminated.
-- Not meeting FDA's request that the shipment be redelivered to
Customs for disposition. According to Customs, about 40 percent
of the imported foods released conditionally by FDA were found
to violate U.S. standards during Operation Bad Apple, but were
never redelivered to Customs. That is, they presumably entered
into commerce and were not destroyed or reexported as required.
Even when the shipments found to violate U.S. standards were
redelivered, Customs officials said other products had been
substituted for the violative products in about 50 percent of
the shipments before redelivery. We found similar results for
the nondelivery of shipments in 1992, when we reported that 60
percent of the perishable foods and 38 percent of the
nonperishable foods that FDA found adulterated with illegal
pesticides were released into U.S. markets and not returned to
Customs for destruction or reexport.\3
Our work suggests that the evasion of imported food controls appears
not to be isolated to a few importers at one port of entry. As part
of Operation Bad Apple, Customs officials monitored cargo transferred
from the vessel to the holding area, FDA sampled and tested the
products, and did not give any conditional releases. Overall, while
about 25 percent of the importers were viewed as suspicious, Customs
anticipated that only 1 percent of these would be found to be evading
controls. However, according to Customs officials, all of the
"suspicious" importers were found to be out of compliance, and 25
percent of the other importers were also out of compliance. FDA and
Customs officials told us that substitution of imported products or
failure to redeliver products for inspection has been occurring at
other ports.
Some Customs officials said they lack the resources needed to witness
and thus ensure proper disposition of violative products refused
entry. Accordingly, they generally verify only the number of
containers--e.g., three containers were refused entry and three
containers were reexported. Similarly, they frequently do not
witness the destruction of the violative product and instead rely on
a receipt from the landfill where it was disposed of. According to
Customs officials, their regulations allow them to accept a receipt
in lieu of witnessing the shipment's destruction.
--------------------
\3 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
PENALTIES DO NOT EFFECTIVELY
DETER ILLEGAL DISTRIBUTION
OF IMPORTED FOODS
-------------------------------------------------------- Chapter 4:3.2
In addition to FDA's difficulties in controlling imported foods prior
to releasing them into domestic commerce, FDA's economic deterrent to
noncompliance with its requirements is inadequate. Lacking the
authority to fine importers who distribute adulterated food shipments
or fail to retain shipments for inspection, FDA relies on a bond
agreement between Customs and the importer, for those shipments
valued at more than $1,250 as a way to achieve compliance. Under the
bond agreement, importers are required to pay all duties, taxes, and
charges; to retain control over the shipment; and to properly dispose
of the shipment if it is found to be unacceptable. The bond amount
is based on the importer's declared value of the imported shipment,
and penalties may be assessed at up to three times the value of the
bond. However, we reported in 1992 that sometimes even assessed
damages of three times the value of the shipment may not deter the
illegal sale of imported goods because the value of the goods on the
market is greater than the tripled bond amount.\4
Customs often does not collect full damages from importers that fail
to comply with FDA's requirements. For example, in fiscal year 1997,
Customs in Miami assessed and collected damages for about only 25
percent of the identified cases involving the improper distribution
of food products for the previous 12 months. Customs and FDA
attributed the low figure to (1) lax controls in communicating
information about refused shipments between Customs and FDA, (2)
unclear guidance for handling the shipments by Customs officials, (3)
a malfunction of the Customs computer system for storing case files,
and (4) a halt in collections pending the resolution of a court case
involving the collection of liquidated damages. Even when damages
were assessed, they were generally reduced to about 2 percent of the
original assessment. For example, in one case, the damages were
$100,000, based on the declared value of the import shipment, but
Customs reduced the amount to $100. According to Customs
headquarters officials, any reduction in damages must be in
accordance with Customs guidelines, and both Customs and FDA must
agree to reduce the damages when they involve the failure to
redeliver shipments that were refused entry because they violated
product purity and labeling requirements.
FDA's lack of authority to impose civil penalties, and its reliance
on the importer's bond agreement with Customs, have left the agency
without an adequate economic deterrent to the distribution of
adulterated imports. We reported in 1992 that in fiscal years 1988
through 1990, importers at four locations had distributed 336 (34
percent) of the 989 shipments found to be adulterated with
pesticides. Although this rate was lower than the rates of 50
percent and 45 percent that we found in 1979 and 1988, respectively,
it indicated that adulterated imports continue to be distributed to
American consumers. We recommended in that report and others that
FDA be given authority to issue civil penalties to violators.\5 While
FDA submitted legislative proposals seeking civil penalty authority
in 1993, the Congress did not pass the legislation.
--------------------
\4 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
\5 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992) and Pesticides: Status of
FDA's Efforts to Improve Import Monitoring and Enforcement
(GAO/T-RCED-93-55, June 16, 1993).
CONCLUSIONS
---------------------------------------------------------- Chapter 4:4
FDA's lack of controls over shipments selected for inspection leaves
its inspection system vulnerable to unscrupulous importers. Without
sufficient controls, some importers (1) may falsify laboratory test
results on suspect foods to obtain an FDA release, (2) sell
potentially unsafe imported foods before FDA can inspect them, and
(3) sell imported foods that FDA found violative and barred from
entry. Furthermore, importers' bonds are an ineffective deterrent
against attempts to market contaminated products. As a result, FDA
has little assurance that contaminated shipments are kept off U.S.
grocery shelves, and it appears likely that certain importers will
continue to circumvent controls over unsafe food products with
impunity.
We are making no recommendations at this time because, as agreed with
the Chairman, Permanent Subcommittee on Investigations, Senate
Committee on Governmental Affairs, we are continuing work to identify
specific actions needed to strengthen the controls over imported
foods.
AGENCY COMMENTS AND OUR
RESPONSE
---------------------------------------------------------- Chapter 4:5
In commenting on a draft of this report, FDA agreed that it needs to
exercise control over the practice of permitting importers to select
a private laboratory to test shipments automatically detained due to
a history of violations. FDA stated that it is issuing new
instructions to its district offices regarding the use of independent
laboratories. However, FDA further noted that the agency lacks the
explicit authority to require importers to use certain laboratories
or to provide a list of accredited laboratories to importers.
Customs provided comments to correct or clarify information about its
responsibilities and practices. Customs stated that it is impossible
to physically inspect the destruction or export of every refused
shipment and said it is more logical to target their resources to
those shipments and suspected importers posing the greater risk for
noncompliance. Customs said the extent of substitution is probably
limited to certain products and a small number of importers.
However, we found that the substitution of products for inspection
has occurred at ports of entry other than in the San Francisco
example we provided. FDA and Customs officials have also
acknowledged that substitution is occurring at other ports, although
neither we nor they know the full extent of its occurrence. Finally,
Customs disagreed with our statement that violators are seldom
punished effectively and the damages against violators do not
represent an effective deterrent; Customs stated that the current
damages assessed against violators are adequate in most cases.
However, on the basis of our work extending back to 1992,\6 we have
found that liquidated damages do not appear to be an effective
deterrent. In 1992, for example, we reported that the U.S. market
value for selected products always exceeded the declared import value
of the products we surveyed; thus, importers could and, in some
cases, did profit from distributing refused products even after
paying damages to Customs. The example we mention in this report, in
which Customs assessed damages of $100 against an importer with a
shipment having a declared value of $100,000, shows that the
collected damages may be far less than the declared value of the
shipment. We added information in the report to explain that,
according to Customs officials in Washington, D.C., any decision to
mitigate damages against importers for failure to redeliver shipments
that were refused entry because of product purity or labeling
problems requires agreement by both Customs and FDA.
--------------------
\6 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
SELECTED OUTBREAKS OF FOODBORNE
ILLNESSES LINKED TO IMPORTED
FOODS, 1983-97
=========================================================== Appendix I
The Centers for Disease Control and Prevention (CDC) has linked
several significant foodborne outbreaks to imported foods (see table
I.1). According to CDC officials, the agency's investigation of
recent outbreaks related to imported foods may indicate that food
safety problems are more widespread than previously believed. For
example, in the spring of 1996, multiple health departments reported
cases of illness from Cyclospora, a pathogen that had not previously
been proven to be transmitted by food. CDC and other public health
officials were able to link illnesses from Cyclospora with
raspberries from Guatemala; more than 1,000 people in various
locations in the United States and Canada were affected. In 1997,
additional illnesses from Cyclospora, also affecting more than 1,000
people, were also linked with raspberries from Guatemala. CDC and
state and local health departments are not able to identify all cases
of foodborne illness, however, because such illnesses are
underreported and are difficult to trace to their source.
Table I.1
Information on Selected Outbreaks of
Foodborne Illness, 1983-97
Source
----------------------------------
Year Number
of of
outbre illnes Country of
ak ses Pathogen Implicated food origin Location
------ ------ ---------------- ---------------- ---------------- -------------------
1997 1,012 Cyclospora Raspberries Guatemala 17 states;
Washington, D.C.;
and Canada
1997 270 Hepatitis A Frozen Mexico 5 states
strawberries (implicated)
1996 9 Salmonella Homemade cheese Mexico Florida
14 typhi, hepatitis
A
1996 1,465 Cyclospora Raspberries Guatemala 20 states;
Washington, D.C.;
and Canada
1995 242 Salmonella Alfalfa sprouts Seeds from 17 states and
Stanley Netherlands Finland
1994 27 Salmonella Agona Kosher peanut- Israel North America and
phage type 15 flavored savory United Kingdom
snack
1994 171 Shigella Green onions Mexico Illinois
flexneri, type 6 (suspected)
(SF6)
1994 12 Unidentified Raw limpets Portugal Massachusetts and
Norwalk-like (molluscan Rhode Island
agent shellfish)
1992 74 Histamine "Fresh" tuna Ecuador Eastern seaboard
poisoning
(Scombroid)
1991 4 Vibrio cholerae Coconut milk in Thailand Maryland
pudding
1991 12 Vibrio cholerae Crab meat Ecuador New Jersey and New
York
1991 400 Salmonella Poona Cantaloupes Mexico 23 states and
Canada
1990 1,400 E. coli O153:H45 Raw scallops South America 2 U.S. cruise ships
1989 99 Staphylococcal Canned mushrooms Peoples Republic 3 states
toxin--food of China
poisoning
1989 25,000 Salmonella Cantaloupes Mexico 30 states
Chester
1988 202 Hepatitis A Lettuce Mexico Kentucky
(suspected)
1983 169 E. coli O27:H20 Semisoft cheese France 4 states and
Washington, D.C.
-----------------------------------------------------------------------------------------
Source: CDC.
COUNTRIES CERTIFIED BY FOOD SAFETY
AND INSPECTION SERVICE TO EXPORT
MEAT AND POULTRY TO THE UNITED
STATES
========================================================== Appendix II
As of January 1, 1998, the Food Safety and Inspection Service (FSIS)
had determined that the countries listed below have food inspection
systems equivalent to the United States' and are eligible to export
meat and/or poultry products to this country. Since January 1, 1998,
FSIS has suspended Paraguay from exporting meat and poultry products
to the United States because its inspection system was not adequate
to prevent contamination on repeated shipments.
Argentina
Australia
Austria
Belgium
Brazil
Canada
Costa Rica
Croatia
Czech Republic
Denmark
Dominican Republic
Finland
France
Germany
Guatemala
Honduras
Hong Kong
Hungary
Iceland
Ireland
Israel
Italy
Japan
Mexico
Netherlands
New Zealand
Nicaragua
Northern Ireland
Paraguay\1
Poland
Romania
Slovenia
Spain
Sweden
Switzerland
United Kingdom
Uruguay
Source: FSIS.
(See figure in printed edition.)Appendix III
--------------------
\1 Suspended as of January 1, 1998.
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION
========================================================== Appendix II
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
The following are GAO's comments on the Food and Drug
Administration's letter dated April 3, 1998.
GAO COMMENTS
1. While we agree with FDA that the compliance programs contain
specific guidance on inspection requirements, we found that FDA
inspectors rely on the numerical inspection targets set forth in the
annual work plan for guidance. These targets are sometimes
inconsistent with the directions for the compliance program. We
agree that FDA needs flexibility to deal with emergencies as they
arise, but we disagree that the current work plan "clearly reflects
priorities." The inconsistency we identified often leads inspectors
to rely on subjective judgment, which may lead to inspectors'
selecting shipments that do not pose the greater food safety risk to
consumers.
2. We have not evaluated nor endorsed this legislation. Instead,
this report addresses the need for FDA's equivalency authority. This
authority would enable FDA to shift the primary responsibility for
ensuring the safety of imported foods to the exporting country and to
make more efficient and effective use of its limited resources.
3. We have modified the report to reflect FDA's comment that it does
not have explicit authority to require importers to use certain
laboratories nor to provide a list of accredited laboratories to
importers.
4. Our recommendation was not intended to require the immediate
implementation of equivalency requirements. Instead, we envision
that such equivalency requirements would be phased in over time in a
manner that would not unnecessarily disrupt trade. The mandatory
authority to require equivalency would address weaknesses in FDA's
approach to inspections at the port of entry, enable FDA to leverage
its staff resources by sharing the responsibility for food safety
with the exporting countries, and compel FDA to take an active
approach in preventing food safety problems instead of requiring
equivalency after problems are identified. The Congress could
provide reasonable time frames that would allow equivalency to be
implemented over a number of years.
We modified the report to address FDA's technical comments where
appropriate.
(See figure in printed edition.)Appendix IV
COMMENTS FROM THE FOOD SAFETY AND
INSPECTION SERVICE
========================================================== Appendix II
(See figure in printed edition.)
The following is GAO's comment on the Food Safety and Inspection
Service's letter dated April 7, 1998.
GAO COMMENT
1. In response to FSIS' comment, we (1) expanded the list of reasons
for refusal that are directly related to health risks to include
unsound condition and residues, as FSIS cited in its comments, and
(2) excluded all refusals resulting from transportation damage
because FSIS officials said these refusals do not trigger
requirements for FSIS to conduct subsequent inspections. Using this
expanded definition, we recalculated the percentage of rejected
shipments that were not directly related to health risk. As a
result, in our final report, we changed the percentage of refused
shipments not related to health risk from 97 percent to 86 percent.
(See figure in printed edition.)Appendix V
COMMENTS FROM THE U.S. CUSTOMS
SERVICE
========================================================== Appendix II
(See figure in printed edition.)
(See figure in printed edition.)
The following are GAO's comments on the U.S. Customs Services'
letter dated April 6, 1998.
GAO COMMENTS
1. We disagree with Customs' comment questioning our assertion about
the extent to which importers substitute safe food products for
imported products for inspection. Customs officials in San Francisco
provided us the figures on import substitution to illustrate the
weaknesses in controls over FDA-regulated imported foods found in
Operation Bad Apple. We modified the language in the report to
clarify that the 50-percent substitution rate was attributed to
Operation Bad Apple. Furthermore, while we cannot report on the
exact extent of product substitution, Customs and FDA officials have
acknowledged that it is occurring at other ports of entry. We also
found that product substitution was occurring at four of the six
ports we visited.
2. We have expanded the report to reflect Customs' comment on the
reasons for a decrease in collections at the Miami port of entry.
3. We do not share Customs' view that the current liquidated damage
assessment for failure to redeliver contaminated food products is an
adequate deterrent. Our work, beginning in 1992,\1 indicates a
pattern of problems in the deterrence and punishment of violators.
In 1992, for example, we reported that the U.S. market value for
selected products always exceeded the declared import value of the
products we surveyed; thus, importers could and, in some cases, did
profit from distributing illegal products even after paying damages
to Customs. The case we mentioned in this report, in which Customs
assessed damages of $100 against an importer with a shipment having a
declared value of $100,000, shows that the collected damages may be
far less than the declared value of the shipment. We modified the
report to provide further information on the reason for mitigating
damages against importers.
--------------------
\1 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
MAJOR CONTRIBUTORS TO THIS REPORT
========================================================== Appendix VI
Keith W. Oleson, Assistant Director
Dennis Richards, Project Leader
Daniel F. Alspaugh
Judy K. Hoovler
John M. Nicholson, Jr.
Carol Herrnstadt Shulman
Jonathan M. Silverman
*** End of document. ***