I. 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 primarily on inspection and testing at
the border to ensure that imported food products meet our food safety
requirements. While this approach was sufficient 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.
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:
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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.
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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.
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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.
