Food Safety: Federal Efforts to Ensure Imported Food Safety Are
Inconsistent and Unreliable (Testimony, 05/14/1998, GAO/T-RCED-98-191).

Federal agencies cannot ensure that the growing volume of imported foods
is safe for consumers. The Food Safety and Inspection Service, which has
jurisdiction over meat, poultry, and some egg products, places the
burden for safety on the exporting countries by allowing imports only
from those countries with food safety systems that it deems to be
equivalent to the U.S. system. In contrast, the Food and Drug
Administration (FDA), which regulates all other foods, lacks such legal
authority. As a result, it 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. Port-of-entry inspections are
ineffective, however, because (1) this approach does not guarantee that
foods are produced under adequately controlled conditions; (2) FDA
currently inspects less than two percent of all foreign shipments; and
(3) inspections will not detect some organisms, such as cyclospora. In
addition, GAO questions whether the Food Safety and Inspection Service
and FDA are targeting their inspection resources at those imported foods
posing the greatest safety risks. Moreover, FDA's procedures for
ensuring that unsafe imported foods do not reach U.S. consumers are
vulnerable to abuse by unscrupulous importers.

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

 REPORTNUM:  T-RCED-98-191
     TITLE:  Food Safety: Federal Efforts to Ensure Imported Food
	     Safety Are Inconsistent and Unreliable
      DATE:  05/14/1998
   SUBJECT:  Food supply
	     Safety regulation
	     Contaminated foods
	     Food inspection
	     Food industry
	     Import regulation
	     Consumer protection
	     Fines (penalties)
	     Health hazards
	     Agricultural products

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GAO/T-RCED-98-191

Cover
================================================================ COVER

Before the Permanent Subcommittee on Investigations, Committee on
Governmental Affairs, U.S.  Senate

For Release
on Delivery
Expected at
9:30 am EDT
Thursday
May 14, 1998

FOOD SAFETY - FEDERAL EFFORTS TO
ENSURE IMPORTED FOOD SAFETY ARE
INCONSISTENT AND UNRELIABLE

Statement of Robert E.  Robertson, Associate Director,
Food and Agriculture Issues,
Resources, Community, and Economic Development Division

GAO/T-RCED-98-191

(150650)

Abbreviations
=============================================================== ABBREV

  FDA - Food and Drug Administration
  FSIS - U.S.Department of Agriculture's Food Safety and Inspection
     Service
  CDC - Centers for Disease Control and Prevention

============================================================ Chapter 0

Madam Chairman and Members of the Permanent Subcommittee:

Thank you for the opportunity to discuss our work on federal efforts
to ensure the safety of imported foods.  As the American public
consumes more and more foods from other countries, the challenge of
ensuring the safety of these foods is growing.  Recent outbreaks of
foodborne illnesses demonstrate that imported foods have introduced
new risks or have increased the incidence of illnesses.  As imports
increase, it is imperative that federal agencies have the most
effective systems in place, and make the best use of their limited
resources, to ensure that imported foods are safe to eat.  The
primary responsibility for ensuring the safety of imported foods is
split between two federal agencies:  the Department of Health and
Human Services' Food and Drug Administration (FDA) and the U.S.
Department of Agriculture's Food Safety and Inspection Service
(FSIS).  FSIS and FDA work closely with the U.S.  Customs Service
(Customs) in the Department of the Treasury and the Centers for
Disease Control and Prevention (CDC) in the Department of Health and
Human Services in carrying out their responsibilities.

Today, I will discuss findings from our recent report in which we
pointed out how limitations in FDA's authority and approach for
regulating imported foods adversely affect its ability to ensure food
safety, how FDA's and FSIS' procedures for selecting shipments to
review result in the ineffective targeting of inspection resources,
and how weaknesses in FDA's and Customs' controls allow unscrupulous
importers to market unsafe products.\1

In summary, we found the following:

  -- The Food and Drug Administration lacks the legal authority to
     require that countries exporting foods to the United States have
     food safety systems equivalent to ours--an authority that the
     Food Safety and Inspection Service has and uses to share the
     burden of ensuring safe foods with the exporting countries.
     Without such authority, the Food and Drug Administration must
     rely primarily on its port-of-entry inspections, which covered
     less than 2 percent of shipments in 1997, to detect and bar
     unsafe foods.  Such an approach has been widely discredited as
     an effective protective measure.

  -- Both the Food and Drug Administration and the Food Safety and
     Inspection Service could make better use of their inspection
     resources by using available health risk information to target
     shipments for inspection that pose the highest food safety risk.
     Additionally, the Food and Drug Administration could further
     improve the use of resources by clarifying its communications to
     inspectors about which shipments to select and by taking
     enforcement action when importers are found to inaccurately
     describe the contents of shipments.  With such improvements, the
     Food and Drug Administration could better ensure that it is
     using its scarce resources to identify the foods posing greater
     risks.

  -- 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.  Under current
     procedures, the Food and Drug Administration generally allows
     importers to retain control over shipments until the agency
     grants their release.  If importers move shipments into domestic
     commerce without a Food and Drug Administration release--that
     is, before the Food and Drug Administration inspects them or
     when a Food and Drug Administration laboratory test reveals the
     products do not meet U.S.  standards--the Food and Drug
     Administration has no effective means of compelling importers to
     return the shipments for inspection, destruction, or reexport.
     In addition, when the Food and Drug Administration requires an
     importer to provide evidence that a suspect shipment is safe,
     the agency allows the importer to select the laboratory that
     picks the samples to be tested and that conducts the tests.
     Finally, the Food and Drug Administration's and Customs'
     principal deterrent for ensuring that importers comply with U.S.
     requirements--the collection of damages from violators--is
     uneven and uncertain.

--------------------
\1 Food Safety:  Federal Efforts to Ensure the Safety of Imported
Foods Are Inconsistent and Unreliable (GAO/RCED-98-103, Apr.  30,
1998).

   BACKGROUND
---------------------------------------------------------- Chapter 0:1

Foodborne illnesses in the United States are widespread and costly.
While the magnitude of the problem is uncertain, we reported in May
1996 that studies have estimated up to 81 million cases of foodborne
illnesses and as many as 9,100 deaths occur each year.\2 Recent
estimates suggest that the number of illnesses may be even higher.
While there is a wide range of estimates, according to the U.S.
Department of Agriculture, the cost of these illnesses and deaths,
measured in medical treatment and productivity losses, have been
estimated to range from $7 billion to $37 billion a year.

A significant amount of the food we consume is imported, and the
percentage is growing.  For example, between 1980 and 1995, the
imported share of all fresh fruit consumed by the American public
rose from about 24 percent to about 33 percent, and the imported
share of seafood rose from about 45 percent to about 55 percent.  FDA
estimates that the volume of imported fruits and vegetables will grow
by 33 percent between now and 2002.  The sheer volume of these
imports, along with the difficulty in ensuring that they are safe,
adds to the risk of foodborne illnesses and makes it essential that
steps to ensure their safety are effective.

Some of these imported foods pose especially significant risks of
foodborne illness.  They can introduce pathogens previously uncommon
in the United States, such as new strains of Salmonella and the
Cyclospora parasite.  In 1996 and 1997, outbreaks of foodborne
illness linked with the Cyclospora parasite in raspberries from
Guatemala affected nearly 2,500 people in the United States and
Canada, causing prolonged gastrointestinal distress and other painful
symptoms.  In addition, imported foods may contain pathogens, such as
hepatitis A, that cannot be easily detected by examination or even
laboratory analysis.

FSIS has jurisdiction over meat, poultry, and some egg products,
while FDA regulates all other foods.  FSIS and FDA work closely with
Customs and 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.

As we have reported numerous times, the U.S.  food safety system is
characterized by a fragmented organizational structure with numerous
agencies implementing a hodgepodge of inconsistent regulations and
laws.  This lack of a uniform, risk-based approach has adversely
affected our nation's ability to protect itself from a host of
domestic food safety problems.  That same fragmented structure and
inconsistent regulatory approach is being used to ensure the safety
of imported foods as well.

--------------------
\2 Food Safety:  Information on Foodborne Illnesses (GAO/RCED-96-96,
May 8, 1996).

   LACK OF EQUIVALENCY AUTHORITY
   DIMINISHES FDA'S ABILITY TO
   PROTECT U.S.  CONSUMERS
---------------------------------------------------------- Chapter 0:2

To ensure the safety of meat and poultry imports, FSIS has a
statutory mandate to require that each country wishing to export meat
and poultry products to the United States demonstrate that it has an
equivalent food safety system.  As of January 1998, FSIS had
certified the eligibility of 37 countries for exporting meat and
poultry to the United States.  FSIS has used equivalency authority to
shift most of the responsibility for food safety to the exporting
country, which performs the primary inspection of products before
they reach the United States.  This approach allows FSIS to leverage
its resources by focusing its reviews on verifying the efficacy of
exporting countries' systems rather than by relying primarily on
ineffective, resource-intensive port inspections to ensure the safety
of imported foods.

In contrast, FDA, although it is expected to ensure that imported
fruits and vegetables and other foods meet U.S.  standards, does not
have a similar equivalency authority and therefore cannot require
that countries exporting food products to the United States have
safety systems in place that are equivalent to ours.\3 As a result,
FDA must rely primarily on selecting and testing import samples at
ports of entry to ensure that foods are safe.  Such an approach has
been widely discredited by the United Nations Food and Agriculture
Organization, an FDA Advisory Committee, and our own analyses as
ineffective because individual product samples tested at the ports of
entry may not represent the health risks of all shipments from that
exporter.  To exacerbate matters, FDA has been unable to keep pace
with increasing imports, and its inspection coverage has fallen from
an estimated 8 percent of import shipments in fiscal year 1992 to an
estimated 1.7 percent in fiscal year 1997.

Given the ineffectiveness of port-of-entry inspections, FDA cannot
realistically ensure that unsafe foods are kept out of U.S.
commerce.  Even if FDA could inspect more shipments at ports of entry
than it currently does, such an approach would still provide little
assurance that imported foods are picked, processed, and packed under
sanitary conditions because inspectors have no assurance that the
exporting country has an effective food safety system.  An
equivalency requirement would allow FDA to share the burden of
ensuring safety with the exporting country and allow it to make
better use of limited resources.  FDA agrees it needs such authority
but believes the authority should be discretionary, so that
equivalency could be applied when FDA believes it is most
appropriate, thus limiting disruptions in trade.  In our April 1998
report we recommended that equivalency should be mandatory for all
imported foods, but the requirement could be phased in, so that it
would not disrupt trade.  Such mandatory authority would (1) impel
FDA to take a proactive approach to preventing food safety problems,
instead of requiring equivalency in countries after problems become
apparent and (2) enable FDA to leverage its staff resources by
sharing responsibility for food safety with exporting countries.

--------------------
\3 In 1997, an administration initiative on food safety proposed
equivalency authority for FDA.

   AGENCIES COULD MORE EFFECTIVELY
   TARGET RESOURCES TO INSPECT
   UNSAFE FOODS
---------------------------------------------------------- Chapter 0:3

FSIS and FDA use computer systems to review information on each
import shipment and to help identify the import shipments requiring
inspector action.  However, neither agency's system takes maximum
advantage of available data to target those imported foods posing the
greater health risks.  Each agency has opportunities to use its
resources more effectively.

FSIS relies primarily on the violation history of previous shipments
from the exporting firm to target entries for inspections or
laboratory tests, but the 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 consumer safety.  In 1996, about 86 percent of FSIS' refused
shipments, excluding those refused entry for transportation damage,
were not directly related to health risks such as excessive residues,
microbiological contamination, unsound condition, or defects caused
by disease.  Nevertheless, 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 greater
health risks.

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 an exported product and
increase its inspection frequencies for such shipments.  FSIS
possesses raw data on those problems but has not designed its
computer system to use these data to identify patterns of violations,
such as firms or countries with repeated problems, that are directly
related to food safety.  According to FSIS, the agency will consider
modifying its automated screening system to identify patterns on
violations when it redesigns the system this year.

FDA's system for selecting imports for examination relies heavily on
inspectors' judgment.  To help its inspectors make informed
judgments, FDA provides a number of tools, such as annual work plans,
compliance programs, and databases containing historical or other
pertinent information to inspectors.  However, these tools are often
confusing, inconsistent, or not readily available to FDA inspectors
and hence provide guidance of little practical value.

Specifically, FDA's annual work plans set 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.  Each
day, the inspectors attempt to select shipments on the basis of the
work plan's targets.  According to FDA, its compliance programs, not
the work plans, contain specific guidance on inspection requirements.
However, 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 direction given in
the compliance programs.  Such inconsistency in guidance for
inspectors serves only to distract and confuse them as they attempt
to carry out their duties on a daily basis.

Moreover, 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 on shipments to
identify those shipments posing the greatest food safety risks.  With
respect to laboratory tests, FDA has not integrated its laboratory
database with its automated import screening system; thus, inspectors
do not have the results of prior laboratory tests available when
making decisions on which imported products to inspect.

Furthermore, FDA inspectors do not have ready access to some useful
data on previous violations by foreign plants in the automated import
screening system when making their decisions on which products to
inspect.  For example, FDA has databases with information on prior
violations by foreign plants or countries and information on
registrations of foreign firms producing certain canned foods, but
the automated import screening system cannot review the databases,
and the process for having the inspectors do so can be cumbersome and
time-consuming.  To obtain these data, inspectors must close their
automated import screening system and open the other databases.  We
observed this process and found that it took 3 to 10 minutes each
time the inspector wanted to switch from one database to another.
Given that inspectors may have to process as many as 200 shipments
per day, not all inspectors bother changing databases to look for
this information.

Instead, inspectors told us, they often rely on their memory of the
information in the database or notes.  Because inspectors have these
difficulties in obtaining needed data on health-related risks and are
under time pressure, they decide which samples to select on the basis
of incomplete information.  As a result, inspectors may rely on
individual biases.  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 were contaminated
with filth.  This inspector routinely selected samples of food from
that country for filth tests, although the laboratory staff told us
that such tests were lower priority than tests for microbiological
contamination and therefore were frequently not conducted.  As a
result, the resources used to select these samples were not
effectively used.  According to FDA officials, the agency received
funds to enhance the screening system in fiscal year 1998 and will
begin integrating the databases (the Laboratory Management System,
the Import Alert Retrieval System, and the Low-Acid Canned Food
database) with the automated import screening system this year.

Finally, the information identifying the contents of imported food
shipments is, in most cases, entered directly into an automated
import processing system by importers, some of whom have an incentive
to misrepresent their goods in the interest of avoiding inspectors'
scrutiny.  Importers who have demonstrated competency with the
electronic system, known as paperless filers, are allowed to enter
shipping information into the system without providing actual
shipping documents to FDA.  To ensure accuracy, FDA retrospectively
verifies a sample of the importer-provided information and, according
to its guidelines, may withdraw paperless filing privileges from
filers with error rates of 10 percent or higher.  However, FDA
records show that no corrective actions to withdraw paperless filing
privileges have been taken for even the most error-prone paperless
filers.  According to a January 1998 FDA survey, over 300 paperless
filers, nearly 15 percent of those audited, had error rates of 10
percent or greater, but paperless privileges were not withdrawn from
any of these filers.  As a result, importers aware of FDA's inaction
could evade FDA's inspections by incorrectly describing the contents
of a shipment.  Such intentional circumvention was demonstrated in
1993, when an importer was found guilty on 138 counts, mostly related
to misrepresenting the source of seafood in an attempt to avoid FDA's
automatic detention.

   WEAKNESSES IN IMPORT CONTROLS
   ALLOW THE ENTRY OF UNSAFE
   PRODUCTS
---------------------------------------------------------- Chapter 0:4

In addition to the problems associated with FDA's system for
selecting food shipments for inspection, several weaknesses in its
controls over imported products enable some importers or their
representatives to sell unsafe foods in the United States.  Because
of these weaknesses, some importers are able to (1) falsify
laboratory test results on suspect foods to obtain FDA's approval to
release them into commerce, (2) sell potentially unsafe imported
foods before FDA can inspect them, and (3) sell imported foods even
when FDA has found a violation and prohibited entry.  In addition to
the absence of controls, violations are seldom punished effectively.
In this environment, FDA has little assurance that contaminated
products are kept off U.S.  grocery shelves.

With respect to falsifying laboratory test results, 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--importers are allowed to
choose the laboratory that selects and tests the samples.  In fiscal
year 1997, FDA detained nearly 8,000 import shipments automatically
because it had identified violations in previous shipments of related
products.  Most of these shipments, according to FDA, were released
after importers presented their private laboratory test results
showing that the shipments met U.S.  standards.  However, Customs and
FDA officials are concerned over the reliability of private
laboratories chosen by importers and hence the reliability of their
test results.  According to Customs inspectors, some importers, to
ensure their products appear to meet U.S.  requirements, share
shipments that have already been tested and proven to be in
compliance--a practice referred to as "banking." FDA says it lacks
the explicit authority to place restrictions on which laboratories
importers can use to test products.  Thus, FDA cannot control the
selection of the samples tested nor insist on objective testing.

FDA does not maintain control over products before releasing them
into U.S.  commerce, enabling importers to sell products before
inspection or even after FDA has found a violation.  Importers of
FDA-regulated foods generally retain possession of import shipments
until FDA releases them and must make the shipments available for
FDA's inspection if requested.  At the ports we visited, imported
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.  In Operation Bad Apple, which took
place in San Francisco in 1997, Customs officials identified 23
weaknesses in controls over FDA-regulated foods.  Importers'
practices to circumvent FDA's controls included (1) ignoring FDA's
requests that shipments in violation be redelivered to Customs for
disposition and (2) substituting cargo so that FDA inspectors would
not see contaminated foods.  In this investigation, Customs found
that about 40 percent of the imported foods determined to violate
U.S.  standards were never redelivered to Customs for destruction or
export, as required, and presumably entered domestic commerce.
Moreover, when shipments were redelivered to Customs for destruction
or export, Customs officials said other products had been substituted
in about 50 percent of the shipments before redelivery.  The results
of this investigation are consistent with the findings in our 1992
report on pesticides,\4 which found that 60 percent of the perishable
foods and 38 percent of the nonperishable foods that FDA found to be
adulterated with illegal pesticides were released into U.S.  markets,
or not returned to Customs for destruction or reexport as required.
Customs and FDA officials recognize that this problem is occurring at
other ports.

In addition, there are few consequences for importers found to
violate safety standards.  Lacking the authority to fine importers
who distribute adulterated food shipments or who fail to retain
shipments for inspection, FDA relies on a bond agreement between
Customs and the importer for most shipments as a way to achieve
compliance.  The bond amount is based on the importer's declared
value of the imported shipment, and damages (i.e., penalties) may be
assessed against violators at up to 3 times the value of the bond.
But such penalties are ineffective because 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.  Customs and FDA attributed the low figure to (1) laxity in
communicating information about refused shipments between the
agencies, (2) unclear guidance for Customs officials' handling of the
shipments, (3) a malfunction in 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 damages.  Even
when the damages were assessed, Customs only collected about 2
percent of the original assessment.  In one case, Customs collected
damages of $100 from one importer for not returning a shipment with a
declared value of $100,000.  According to Customs officials, any
reduction in damages must be in accordance with Customs guidelines,
and both Customs and FDA must agree to reduce the damages.

--------------------
\4 Pesticides:  Adulterated Imported Foods Are Reaching U.S.  Grocery
Shelves (GAO/RCED-92-205, Sept.  24, 1992).

-------------------------------------------------------- Chapter 0:4.1

In conclusion, Madam Chairman, we believe that it is vitally
important that the nation's efforts to ensure the safety of imported
foods be improved.  As the portion of the U.S.  food supply from
imported sources continues to grow, it is clear that the safety of
the U.S.  food supply cannot be ensured unless food imports are safe.
However, our system for keeping unsafe imported foods from entering
the food supply has a number of weaknesses.  These weaknesses can and
should be addressed.  We have made a number of recommendations to
this end in our recent report, and we hope to develop additional
recommendations as part of our ongoing work for you.

That concludes our prepared statement.  We would be happy to respond
to any questions you or members of the subcommittee may have.
*** End of document ***