STATEMENT BY
WILLIAM B. SCHULTZ
DEPUTY COMMISSIONER FOR
POLICY
FOOD AND DRUG
ADMINISTRATION
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BEFORE THE
PERMANENT SUBCOMMITTEE
ON INVESTIGATIONS
COMMITTEE ON GOVERNMENT
AFFAIRS
UNITED STATES SENATE
SEPTEMBER 24, 1998
INTRODUCTION
Good morning, Madam Chairman, Members of the Committee. I am
William B. Schultz, Deputy Commissioner for Policy, Food and Drug
Administration (FDA or the Agency). With me today are Joseph Levitt,
Director, Center for Food Safety and Applied Nutrition (CFSAN), and Gary
Dykstra, Deputy Associate Commissioner for Regulatory Affairs (ORA).
We appreciate the opportunity to participate in this hearing, and we thank
you for the leadership and concern you have demonstrated on the issue of
the safety of imported foods.
II. BACKGROUND
As you know, food safety has been a high priority of this Administration, as
evidenced by the President's Food Safety Initiative and Produce Initiatives.
We believe the reports you have requested from the General Accounting
Office (GAO) and the three previous hearings you have held have provided
added focus and clarity to this important issue.
Even though Americans enjoy one of the safest food supplies in the world,
every year tens of millions of Americans become sick and thousands die
from illnesses caused by both domestic and imported food. The increasing
quantities of food that are imported into the United States has raised some
significant questions about our ability to protect consumers from potential
hazards. We agree with those who believe that our approach to the
regulation of food imports needs to be updated to meet the demands of
modern society. We also know that improving FDA's import program will
be a serious challenge. FDA's current program relies at the turn of the
century because relatively few foods were imported, today, we are seeing
changes in food imports that necessitate changes in our approach. We
believe that dramatic new approaches are called for, including improvements
in the existing imported food program, new authorities to more efficiently
implement the program, and a significant infusion of resources, as reflected
in the Administration's budget for FY 1999.
In the remainder of my testimony I will describe our current import program
and give some background on the President's two food safety initiatives,
both of which strengthen our imported foods program. I then will move on
to the GAO Report and the Agency's recommendations for improving how
we fulfill our responsibility to assure the safety of imported foods..
III. FDA'S IMPORT PROGRAM
During the past 12 years, food imports have grown dramatically. In 1985,
only approximately 950,000 line items were offered for
import into the United States. As the attached chart shows, that number
more than tripled to over 3 million line item entries by 1998, and is expected
to continue to increase.
In addition, the nature of imported foods has changed. In the past, most
imported products consisted of raw or bulk materials which were further
processed into finished products in the United States. Currently, more and
more food imports consist of finished, value added foods (e.g., cooked,
ready-to-eat, quick frozen shrimp as opposed to raw shrimp for
cooking/processing in this country). As products receive additional
processing, the potential for the product becoming contaminated and a
potential public health hazard increases. For example, the hazard associated
with a microbial pathogen, such as Salmonella, in a ready-to-eat food is
potentially greater than in a product that will be cooked before eaten. As
we all know, fresh produce and seafood can pose additional risks,
particularly with emerging pathogens. Today, 38 percent of fruit consumed
by Americans, 12 percent of vegetables, and 50 percent of seafood are
imported. As noted by the August 1998 report by the Institute of
Medicine/National Research Council, Ensuring Safe Food: From
Production To Consumption, (IOM/NRC Report), sample analysis is not
adequate to detect many of the more serious risks from these
microbiological hazards. To monitor adequately the safety of many
imported foods, it has become necessary to understand and be able to
evaluate the conditions under which they are grown, manufactured, and
transported.
Meanwhile, the resources allocated to the inspection of imported foods have
actually decreased. In 1992, we received approximately 1.1 million line
items of imported foods and had 631 supported Full Time Equivalent
employees (FTEs) to look at those items. By 1997, our line items more
than doubled to approximately 2.7 million but budget limitations caused us
to cut our supported FTEs to 565. Of these 565 FTEs, only 314 are what
we refer to as "operational," with 112 actual investigators and 202
analyzing samples in the laboratories. (The others are support staff,
including those at headquarters.) In practice, this means that in 1992 we
were able to physically inspect 8 percent of all imported foods. Today, the
Agency physically inspects only 1.6 percent of imported food. A single entry
may contain multiple line items of food offered for import. Each line item
corresponds to a specific item on the invoice or shipping papers.A single
entry may contain multiple line items of food offered for import. Each line
item corresponds to a specific item on the invoice or shipping papers.
Since resources are limited, FDA sets its priorities by focusing on risk, and
therefore, by placing an emphasis on the analysis of foods upon import for a
variety of hazards, which include heavy metals, pesticides, chemical
contaminants, natural toxins, allergens, pathogens, histamine in seafood, etc.
The presence of some of these hazards can lead to illness or death. Given
our risk-based strategy, FDA focuses its import activities on problem,
product, and country. For example, a higher priority is given to low-acid
canned foods to protect against potentially fatal botulism, as well as other
ready-to-eat foods susceptible to pathogen contamination (such as Listeria
monocytogenes and Salmonella), while a lower priority is given to issues
less directly related to public health, such as minor labeling violations.
In recent years, FDA has implemented several enhancements to its program
in response to the increase in imported foods. We have developed an
automated screening system, which receives data via United States Custom
Service (USCS) system, capable of electronically reviewing information
submitted by filers. This system, Operational and Administrative System for
Import Support (OASIS), has been operating in all FDA districts since
October 1997. FDA uses OASIS to screen shipment information using a
variety of risk-based criteria. These criteria include the type of product, the
country of origin, the foreign manufacturer, and the foreign shipper.
Criteria used in screening always includes a default examination rate, so that
products that might otherwise not meet any criteria triggering FDA review
could randomly be considered for review. This default system ensures that
every product offered for import has some possibility of being examined.
OASIS determines whether a shipment may proceed into domestic
commerce, needs further review, or must be detained.
Let me now explain briefly how the Agency's current import program
works. Using the relatively new OASIS system, FDA reviews all food
entries offered for import, either electronically or by staff evaluation. Based
on this review, each entry is designated either a "May Proceed without FDA
examination" or "FDA Review". After an "FDA Review," the product may
be redesignated "May Proceed," selected for "Examination," identified for
"Detention Without Physical Examination," or the filer can be told to submit
additional documents before FDA can make an entry determination.
Through this electronic review, approximately 55 percent of all FDA food
line items are categorized as "May Proceed" and are admitted into domestic
commerce within minutes. In FY 1997, of the 2.7 million food line items,
approximately 1.5 million were categorized as "May Proceed" based on
electronic screening.
The entries that do not receive a "May Proceed" are subject to additional
review, and the filer may be required to submit paper documentation for the
entry. FDA inspectors verify whether certain information submitted by the
filer is accurate and determine if the product, country, shipper, importer,
and/or manufacturer are the subject of an Import Alert.
The inspector will make a decision to release or detain the entry or to
sample or conduct a field examination. When FDA detects the appearance
of a violation, the Agency detains the product. Detention is intended to
prevent the products from entering domestic commerce until the importer
submits information to FDA that overcomes the appearance of a violation,
or the products are brought into compliance with the law through
reconditioning if this is appropriate. Where the importer fails to overcome
the appearance of a violation or where detained products cannot be brought
into compliance, FDA refuses admission of the products into the United
States, and the products must be destroyed or re-exported, according to
USCS regulations. FDA also can seize violative imported products, which
involves a formal judicial action.
In addition to having the authority to refuse entry of an apparently violative
import, FDA may detain products without physical examination when they
consistently violate FDA requirements or when FDA has information that
they are health hazards. The products of importers who frequently have
presented violative products for import or who have tried to evade the law
may be detained without physical examination. Under this control measure,
all subsequent shipments of the suspect product may be detained upon
import (not distributed in domestic commerce) until either the importer,
shipper, producer, or a responsible agency of the exporting country provides
information establishing, to FDA's satisfaction, that the shipment is in
compliance.
By providing uniform entry screening to all districts, the OASIS system
helps to ensure that problem products will be recognized as such at
whatever port they enter. The review criteria can be revised within minutes
to respond to emerging problems. The OASIS system accomplishes in
minutes what used to take days.
IV. ENHANCEMENTS UNDERWAY TO THE CURRENT
IMPORT PROGRAM
FDA currently is updating OASIS to make it a more efficient and effective
tool. We are enhancing the system to link various Agency databases to
OASIS, which will allow inspectors easy access to additional Agency
databases (such as Import Alerts and Low-Acid Canned Food registrations)
that might have risk information relevant to the decision about how a
particular shipment should be handled. This improvement to the existing
system will reduce the amount of time needed to determine what action to
take on individual entries and is expected to be operational by the end of the
year.
The Agency also has safeguards against importers who continue to submit
erroneous entry data. As part of FDA's implementation of the OASIS
system, FDA conducts evaluations of all filers, and strives to evaluate every
filer once a year. FDA randomly selects entries of a given filer that were
designated as "May Proceed" and requests that the filer provide the paper
documentation for these entries. The information on the paper
documentation is compared to the electronic documentation for accuracy
and consistency. When a filer is identified with an error rate in excess of 10
percent and the errors do not appear to be deliberate, FDA will work with
the filer to correct the problem. This effort could include providing
guidance on how to submit their data correctly, or simply taking greater
care to avoid typographical errors. If the filer still cannot achieve an error
rate of 10 percent or less, the filer will be required to submit paper
documentation for every entry until their error rate is reduced to an
acceptable rate. If the pattern of errors indicates deliberate submission of
erroneous data in order to facilitate entry of violative food, the filer must
immediately submit paper documents for all entries, and FDA may refer the
matter for criminal investigation. As of August 1998, out of 2,293
electronic filers, 1,315 were evaluated within a nine month period and 247
were found to have an error rate in excess of 10 percent. Of the 247 filers
with an error rate in excess of 10 percent, only one was removed from
electronic status after efforts were made to assist the filers in making
corrections to reduce their error rate.
Since implementation of the OASIS system began in all districts in 1997,
FDA has been working with the filers to help them learn the system in order
to submit correct data consistently. FDA continues to conduct product
code training and other types of data entry training around the country. We
believe this has been an appropriate approach in light of the recent
implementation and complexity of the system.
V. THE TWO PRESIDENTIAL FOOD SAFETY
INITIATIVES
As the Committee is well aware, improving the overall safety of food has
been a focus of the Clinton Administration. In the past 16 months, the
Administration has announced two major initiatives to improve the safety of
the food supply. The first is the President's May 1997 National Food Safety
Initiative, a multi-agency approach involving FDA, the Centers for Disease
Control and Prevention (CDC), the U. S. Department of Agriculture
(USDA), and the Environmental Protection Agency to reduce the incidence
of foodborne illnesses by enhancing the safety of both domestic and
imported foods. Some of the measures being implemented include an
expanded early warning surveillance system for foodborne illnesses,
strengthened communication between State and Federal agencies to
coordinate the response to foodborne disease outbreaks, education
campaigns directed at consumers and retail food service establishments to
improve food handling practices, focused research on better risk assessment
techniques for foodborne pathogens, and research to develop new methods
to detect and prevent foodborne pathogens. This initiative is described in
greater detail in Food Safety From Farm To Table: A National Food-Safety
Initiative, A Report to the President, May 1997.
In addition, in October 1997, President Clinton issued a two-part directive
specifically to improve the safety of imported and domestic fresh produce.
The first part was a directive to the Secretary of Health and Human Services
and the Secretary of Agriculture to work together and in close cooperation
with the agricultural community to develop voluntary guidance, regarding
good agricultural practices and good manufacturing practices (GAPs and
GMPs). The voluntary guidance targeted towards both the domestic and
foreign industry recommends various approaches to reduce the risk of
microbial contamination of fresh produce throughout the production and
distribution system. We have received a great deal of public input and
worked with the states on this guidance and are revising the guidance based
on this input. We expect to publish the final voluntary guidance in early
October 1998.
The second part of the produce initiative is legislation aimed at ensuring
imported foods are as safe as domestic foods. Because this legislation
directly addresses one of the recommendations in the GAO report, I will
defer my remarks on this topic until after I discuss the report.
VI. ADDITIONAL RESOURCES REQUESTED BY THE
ADMINISTRATION
The Administration also has sought additional funding to implement these
initiatives. With strong support from the Congress, we received the first
installment for the President's Food Safety Initiative in FY 1998 of $24
million, the full increase for food safety sought by the Administration that
year for FDA. This funding has allowed us to lay a foundation for
improving the safety of foods through implementation of Hazard Analysis
Critical Control Points (HACCP) in the seafood industry, as well as develop
activities in the areas of surveillance, research, risk assessment, coordinating
more response to food borne outbreaks at the federal, state, and local levels,
and education. We are proud of a number of significant accomplishments
that have already occurred with this funding. For example, we are using
FoodNet and PulseNet data to identify and contain more quickly outbreaks
before large numbers of people become ill. We have developed new and
improved methods for detection of pathogens, such as Cyclosporasis.
Educational efforts are changing consumers' unsafe food practices; surveys
indicate that fewer consumers are eating raw oysters, improperly cooked
eggs, and rare hamburger. The interagency Risk Assessment Consortium
has been formed as a forum for the development and use of uniform and
consistent approaches to risk assessment in food safety. These are only a
few of the accomplishments made possible by the President's
Initiatives.
For FY 1999, the Administration is requesting $101 million for the Food
Safety Initiative. Our FY 1999 request builds upon this foundation by
targeting the areas of imports and produce. Of the Administration's total
request, $50 million is for FDA. Of this amount, $25 million would be
devoted toward activities to improve the safety of imports. This funding
would be used not only to put additional inspectors at the borders, but also
to take a very proactive approach to imports by evaluating the food
production systems of other countries wishing to export to the U.S. With
this funding, our goals are to conduct such activities as these overseas
evaluations, provide educational outreach and technical assistance to
promote use of GAPs, promote use of Mutual Recognition Agreements and
other agreements, increase the accuracy of import entry data, and increase
sampling of high risk food at the border.
VII. THE GAO REPORT
While FDA is implementing important measures to improve the safety of
food imports, additional improvements must be made. In this regard, the
April 1998 GAO Report makes several observations and recommendations.
The Report's recommendations fall into three main areas:
- First, the Report recommends that Congress require that all
foods imported into the U.S. be produced under equivalent food
safety systems. USDA already has such authority to control
imported meat and poultry products in this manner.
- Second, GAO recommends several improvements to more
effectively target resources on high risk imported foods. These
improvements include altering our work plan to provide better
guidance to our inspectors, enabling our inspectors to access all
health risk databases from OASIS, and ensuring that importers
submit accurate data into our electronic entry system.
- Third, the Report recommends that FDA improve its control
over food imports prior to a decision that such food may proceed in
domestic commerce. These improvements include re-evaluating the
use of private laboratory tests by importers, retaining better control
over questionable products, marking refused items, and imposing
stiffer penalties for those who ship unsafe products.
We agree with many of GAO's findings and recommendations and would
like to address them in turn.
VIII. AUTHORITY TO REQUIRE THAT FOOD
IMPORTS ARE PRODUCED UNDER A
SYSTEM THAT MEETS THE U.S. LEVEL OF
PROTECTION
I first would like to address the recommendation that FDA be given
statutory authority that would enable us to ensure that products imported
into the United States have been produced under a system that provides the
same protection as domestically produced foods. As I have stated
previously, there is no doubt our current system to protect Americans
against unsafe imported products is in need of revision. We simply cannot
rely solely on catching problems at the border through inspection. The
GAO Report has made this a priority and devoted a substantial portion of
the report to this recommendation.
The issue of FDA's support of this proposed authority was questioned at
the May 14 hearing. We fully endorse this recommendation, and the
Administration has requested legislation to give FDA explicit statutory
authority to require that all imported foods are produced under a system
that meets the level of protection applicable to domestic foods. FDA's only
concern has been over GAO's use of the word "equivalent". This concern
arises because the term "equivalent" has a particular meaning in the context
of the World Trade Organization's SPS agreement; it has been interpreted
by some of our trading partners to always require formal agreements. These
agreements involve a lengthy and resource intensive process, which, in our
view, should not be required as part of the statutory authorities that GAO
has recommended.
As you know, S. 1707, introduced by Senators Barbara Mikulski and Ted
Kennedy, (and its companion bill H.R. 3052 introduced by Representatives
Anna Eshoo and Frank Pallone) would add a new provision to section 402
of the Act that would deem imported foods to be adulterated if the
Secretary (and by delegation FDA) determines that the imported products
were not prepared, packed, or held under a system or subject to conditions
that either meet the requirements of our Act or "otherwise achieve the level
of protection" required by our Act for domestic foods. In making that
determination, the Secretary could consider whether the country, firm, or
establishment has allowed FDA access (including sample collection) upon
our request.
This legislation puts the emphasis on underlying systems of control at their
source rather than finding contaminated food shipments at our border or,
worse yet, after people get sick. In other words, it is a move from reaction
to prevention. If enacted, this legislation would achieve a better allocation
of FDA resources by taking into account the production, processing, and
handling of food products rather than only focussing on products when they
are offered for import, a focus we can no longer afford to rely on solely
given the dramatic rise in imported foods and our current level of resources.
This legislation is consistent not only with GAO's recommendation, but also
with the August 1998 IOM/NRC Report.
Let me make one other point. FDA plans to undertake the activities
identified in the President's Food Safety Initiative and Produce Initiative.
While enactment of this legislation would enhance our ability to improve the
safety of imported foods, in the absence of such legislative authority, we
can, and if the additional funds that have been requested are provided, still
move ahead to meet each of the goals listed previously.
IX. TARGETING RESOURCES ON HIGH RISK
IMPORTED FOODS
While there is no doubt we must begin to focus on prevention, we cannot
ignore the continued importance of inspection at the border. The GAO
Report made several recommendations involving the Agency's ability to
target our inspectional resources on high risk imported food products. We
agree that, given current resources, we must focus on those entries that
pose the greatest threat to public health. As I have mentioned, FDA already
has been taking many of the steps recommended by GAO. More
specifically, the Agency has been and will continue to work to link the
OASIS system to other databases, as well as our efforts to work with filers
to prevent the entry of errors into the electronic entry system. In addition,
we are reviewing the tools we use to assist field staff in prioritizing their
work.
FDA supplies guidance to its field staff to target their work. The primary
mechanisms for doing this are Compliance Programs, Assignments, and
Import Alerts and Bulletins. Compliance Programs reflect Agency priorities
based on anticipated risk associated with a product and list individual
products and the problems that can be associated with those products, as
well as countries and or regions from which samples could be collected.
They also contain other guidance based on FDA's past accomplishments
and surveillance information to guide the field force in selecting imported
products to sample. Assignments, containing information similar to that in
Compliance Programs, usually are issued to gather information on new or
emerging problems. Import Alerts and Bulletins identify known or potential
problem foods (by country and manufacturer) and contain guidance to our
field offices as to appropriate actions.
FDA's Workplan, on the other hand, is a management tool used to assign
the number of operations (field examinations, sample collections and
analysis) that the Agency will perform on a national basis. Each district then
is assigned its proportionate share of operations to perform during the year.
The Workplan reflects the Agency priorities contained in Compliance
Programs, but is not the only reflection of overall Agency import priorities.
The GAO report noted that FDA did not meet the goals set forth in the
Workplan, principally because the Workplan did not factor in the time
required to investigate emergencies and consumer complaints. FDA does
not disagree. Consequently, we have established an internal working group
of both field and headquarters personnel to examine how to factor in
emergencies and consumer complaints in order to better plan import work
and report activities. We hope to implement recommendations from this
group in FY 1999.
X. IMPROVING CONTROL OVER IMPORTED FOODS
PRIOR TO RELEASE BY FDA
GAO also recommended that FDA improve its control over imported foods
prior to a decision by the Agency that the goods be allowed to enter into
domestic commerce. I would like to respond to this category of
recommendations by highlighting controls that FDA is currently
considering, some of which can be achieved administratively.
A. Independent Laboratories
FDA generally agrees with GAO's observation that FDA needs to exercise
better control when permitting importers of foods subject to detention
without physical examination to select a laboratory to analyze their
products, to certify that the labs sampled the product once, and that the
information provided is true and correct. To this end, we plan to revise our
internal laboratory procedures manual to offer additional guidance for our
district offices regarding the submission by private laboratories to FDA of
analytical packages in post-detention sampling.
B. Improved Cargo Control
The GAO Report criticized the Agency for allowing the importer to retain
control over imports and GAO observed problems such as substitution of
cargo and failure to redeliver the goods after FDA has refused admission.
This is a serious criticism, and FDA agrees that better controls over
incoming cargo are necessary. We are evaluating new ways to require
importers to securely hold articles identified for detention without physical
examination. One option would be requiring that the goods be held in a
bonded warehouse, at the importer's expense, until FDA makes a final entry
decision. Certain exemptions from any new requirement may apply in some
instances, such as if the Agency has an agreement with the country of origin
establishing that the foreign food safety system meets our level of protection
or if the articles are highly perishable.
C. Marking Refused Goods
An additional control tool would be to require that such products be marked
"refused" or "refused admission" if the articles were rejected under the
Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health
Service Act (PHS Act), or the applicable regulations. FDA currently does
not have explicit authority to mark goods or to require the marking of
goods refused entry. Consistent with the observations made by GAO in the
April report, as well as at the September 10 hearing, however, the Agency is
considering a regulation based upon its implicit authority in the FD&C Act
and the PHS Act. Such a regulation could require the marking of refused
goods to aid the Agency in identifying these products should the importer
attempt to reenter them without reconditioning.
D. Partnership with U.S. Customs Service
An additional theme throughout this section of the GAO report is FDA's
relationship with USCS. We believe that this is a close, cooperative
relationship as shown by our cooperation in investigating criminal activities;
our joint efforts in linking OASIS with the USCS system; and, our daily
contacts in monitoring imports at the over 330 ports-of-entry where FDA-regulated products enter the U.S. But like any relationship, there always is
room for improvement. USCS and FDA already have established a working
group to explore the issue of cargo control and a second working group to
develop mechanisms to improve the sharing of valuable information. The
efforts of these two groups will hopefully enhance the partnership we have
with USCS.
XI. IMPROVING FDA'S ABILITY TO TRACE BACK
FOOD PRODUCTS TO THE SOURCE OF
PRODUCTION
Although the GAO Report did not address our ability to trace food products
back to their production source, the Agency believes such ability can be a
key element of public health protection. For that reason, I would like to
address this issue.
FDA and the food industry share an interest in improving the ability to trace
back and to identify the source of foods that pose health hazards to the
American public, including fresh produce. For FDA (and CDC), a trace
back to the source of production allows us to conduct more thorough
investigations more quickly (before evidence gets lost or spoils). For
industry, more precise identification of the source of production can reduce
instances where consumers believe an entire category of products is unsafe,
when the problem is associated with the products of just one or a small
number of manufacturers, distributors, or growers.
Because of our shared interest in utilizing a trace back, FDA and industry
have had a number of discussions about steps that industry could take to
improve traceability. For packaged food, a trace back can usually be
established because food packages or labels are required to include
information that allows FDA to trace the foods at least to the distributing
firm. Fresh produce presents a very different situation. Many small
producers are involved, and when their products enter our country's vast
and complex distribution system, the information that links a farm to the
product in the supermarket display case can easily be lost. Product marking
seems to be a more pragmatic approach than requiring detailed distribution
records, but even product marking is a complex issue for products typically
sold in bulk, products commingled with products from other sources, and
products sold to the consumer unpackaged. Industry is increasing its use of
stickers or tags, and our investigators have found some of the bar codes
being used on certain wrapped produce an especially efficient source of
information, but these practices are not yet widespread or economically
efficient.
FDA will continue to discuss this issue with the industry. At this time, we
see many practical problems to imposing a trace back requirement. We are
quite hopeful that the industry's keen interest in finding workable solutions
will lead to enhanced product marking practices.
XII. CONCLUSION
Madam Chairman and Members of the Committee, FDA is serious about
significant reforms of its import program. But we believe that neither the
current approach nor the current level of resources to handle the increasing
quantities of foods that are being imported into this country are sufficient.
Instead, as both the President and GAO have recognized, we must change
our approach. Rather than relying solely on inspections at the border, we
must place a greater emphasis on the regulatory systems of the foreign
countries that are exporting to us. In addition, without a significant increase
in resources, as requested in the President's FY 1999 budget, a strong
import program is not possible.
We appreciate and welcome the Committee's interest in this important
subject, and we look forward to working with the Committee to find ways
to improve the Agency's imported food program.
My colleagues and I would be pleased to answer any questions. Thank
you.
1. A single entry may contain multiple line items of food offered for
import. Each line item corresponds to a specific item on the invoice
or shipping papers.
2. Products for which there is a basis to detain without physical
examination are placed on an Import Alert. Import Alerts identify
problem commodities, countries, and/or shippers and provide
guidance to FDA field staff. Occasionally, FDA places products
from an entire country or region of a country on detention without
physical examination when the violative conditions appear to be
geographically widespread. Recent examples of country-wide
Import Alerts include cheese from El Salvador due to a history of
contamination with Salmonella, Escherichia coli, and Staphylococci
aureus, and raspberries from Guatemala due to past outbreaks of
Cyclosporasis.
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