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A. Schwetz, D.V.M., Ph.D.
Acting Principal Deputy
Food and Drug Administration
Committee on Governmental Affairs
Subcommittee on Oversight of Government Management, Restructuring
and the District of Columbia
United States Senate
FOR RELEASE ONLY UPON DELIVERY
afternoon, Mr. Chairman and Members of the Subcommittee.
I am Bernard A. Schwetz, D.V.M., Ph.D., Acting Principal
Deputy Commissioner of Food and Drugs, Food and Drug Administration
(FDA or Agency). Thank you for this opportunity to discuss
the Federal food safety system and to provide testimony
on behalf of the Department of Health and Human Services
(HHS). Ensuring the safety of the food supply is a top priority
for HHS and the Administration. I am pleased to be here
today with my colleague, Dr. Elsa Murano, Under Secretary
for Food Safety in the U.S. Department of Agriculture (USDA).
The American food supply continues to be among the safest
in the world. Great strides have been made in recent years
that have strengthened the Federal food safety system. The
Federal food safety program includes new surveillance systems,
better prevention programs, faster outbreak response, enhanced
education, and better coordinated and focused research and
risk assessment activities. Food safety agencies are working
more closely together than ever before.
But our world is constantly changing, and we must continue
to change with it. Indeed, we cannot rest until we have
built a strong and credible food safety system that addresses
the full range of food safety issues: one that is built
on scientific expertise with recognized stature worldwide;
that is risk-based and recognizes and responds to new risks;
that provides a credible inspection and product sampling
presence; that has the same level of protection to consumers
from both domestic and imported food; that efficiently stewards
new technologies to the market; and that effectively educates
and communicates to consumers.
By way of background, while
FDA has lead responsibility within HHS for ensuring the
safety of food products, HHS's Centers for Disease Control
and Prevention (CDC) has an important complementary and
non-regulatory public health role. As the lead Federal agency
for conducting disease surveillance, CDC monitors the occurrence
of illness in the United States attributable to the food
supply. The disease surveillance systems coordinated by
CDC are an essential information network for early warnings
about dangers in the food supply and progress in reducing
foodborne illness, and for indicating new or changing patterns
of foodborne illness. Because CDC also detects and investigates
outbreaks of foodborne illness through its networks, CDC
is able to alert FDA and USDA to the implicated products
and works closely with FDA agencies to take protective public
health action. In keeping with its agency mission, CDC also
identifies, evaluates, and offers expert scientific opinion
on the effectiveness of foodborne disease prevention strategies.
In addition, just as FDA works with State and local food
safety counterparts, CDC works extensively with State and
local departments to build their epidemiology, laboratory,
and environmental health expertise in foodborne disease
surveillance and outbreak response. All of these collaborations
draw on and apply the unique expertise within HHS to address
significant and emerging challenges posed by our food supply.
I will now discuss some of the challenges we face, describe
the food safety system toward which we should strive, mention
some recent food safety accomplishments, and describe where
we need to go from here.
While much progress has been made in improving the safety
of the food supply, it is important not to underestimate
the significant challenges we face. I would now like to
discuss some of these challenges.
Food Safety Challenges
While the American food supply is among the safest in the
world, there are still too many Americans stricken by illness
every year caused by the food they consume, and some die
as a result. The CDC has estimated that foodborne diseases
cause approximately 76 million illnesses, 325,000 hospitalizations,
and 5,000 deaths in the United States each year. There are
many reasons for this. People are eating a greater variety
of foods, particularly seafood and fresh fruits and vegetables.
As many of these foods are becoming available all year round,
safety concerns associated with transportation and refrigeration
arise. The rising volume of imported foods increases dramatically
the number of potential sources of food contamination. People
are eating more of their meals away from home. In fact,
fifty cents of every food dollar is spent on food prepared
outside the home. As more food workers become involved in
preparing our meals, the opportunity for disease-causing
errors also increases. This problem is especially important
for persons at greatest risk who eat foods prepared in hospitals,
nursing homes, and childcare centers. Indeed, persons at
highest risk for foodborne illness - children, the elderly,
pregnant women, and immuno-compromised persons - now comprise
nearly a quarter of the population.
Other significant changes are the emergence of new foodborne
pathogens and the ability of existing pathogens to overcome
traditional food barriers such as temperature and acidity.
We are aware of more than five times the number of foodborne
pathogens today than we were half a century ago, and we
continue to discover more. Many of these pathogens can be
deadly, especially to those at highest risk.
for a Strong and Credible Food Safety System
The goal of HHS is to strengthen our food safety system
to address the full range of food safety issues. This system
has three simple steps:
- to identify risks;
- to take action; and
- to measure results.
In identifying risks, we must ensure a strong science base
which is the foundation of any successful food
safety system. We must also develop, enhance, and maintain
surveillance systems that can quickly and accurately identify
food safety risks in the human food and animal feed supplies
and manage disease risks effectively. These surveillance
systems are the key to an effective emergency response capability.
In taking action, we must start with prevention. That is
how we, ultimately, will be most successful. We need strong
risk-based prevention standards to prevent contamination
of all human foods and animal feeds over the farm-to-table
continuum. As these risk-based prevention standards are
developed, we need education and training programs so that
those in the industry and the public can effectively utilize
them to reduce the risk of foodborne illness and minimize
harm if illness develops.
Education is not enough. We need to verify. Domestic inspections
of the food industry are essential to ensure application
of appropriate preventive controls. And for imported food,
we need a strong inspection and monitoring program to ensure
that imported foods meet the same level of consumer protection
as domestic foods. For both domestic and imported food,
we need to maintain an adequate enforcement program to be
sure the rules are followed.
Finally, we need science-based methods to measure results
so we know how we are doing. The FoodNet system described
below provides information on pathogens. We need similar
mechanisms for other foodborne hazards. If implemented,
such a framework would minimize foodborne illness and injury,
maximize consumer safety and confidence, and enhance global
Even in the face of many challenges, there has been substantial
progress in reducing to the greatest extent possible foodborne
illness due to microbial contamination. Thanks to the budgetary
support provided by Congress, this multi-agency effort has
successfully built a strong foundation for a state-of-the-art,
science-based food safety system and has promoted partnering
among the key Federal agencies, States, academia, industry,
and consumers. We intend to take a comprehensive approach
that addresses all food safety hazards - microbiological,
chemical, and physical - for products under FDA's jurisdiction.
As mentioned above, we now have in place newer surveillance
systems, stronger prevention programs, faster outbreak response,
and a risk-based philosophy that guides our research, risk
assessments, and educational efforts. Preventive controls
implemented by the Federal agencies, such as good agricultural
practices for produce and eggs and HACCP systems for meat
and poultry, have already shown results. There are also
numerous interagency and Federal/State partnerships that
have been formed to utilize more efficiently our collective
I would now like to highlight just a few of the recent
food safety achievements.
The primary objective of the American system of public
health is to prevent disease before it occurs. Surveillance
and monitoring are critical to meet this objective.
FoodNet Surveillance Network. A strong
food safety system starts with knowing where the problems
are and identifying new problems rapidly. The Foodborne
Diseases Active Surveillance Network (FoodNet) is part of
CDC's Emerging Infections Program. It is a collaborative
project of the CDC, USDA, FDA, and nine States. This project
began in 1995 to more precisely characterize the incidence
and trends in foodborne illnesses, and to conduct systematic
investigations to help public health officials better understand
the epidemiology of foodborne disease in the U.S. Now expanded
to nine sites covering 36 million people (13 percent of
the U.S. population), FoodNet provides a strong network
for responding to new and emerging foodborne diseases of
national importance, monitoring the burden of foodborne
diseases, and identifying the source of specific foodborne
diseases, all with a view toward developing and implementing
effective prevention and control measures.
PulseNet. PulseNet, developed by CDC,
enables a national network of public health laboratories
to "fingerprint" bacteria that may be foodborne and compare
results through an electronic database maintained by CDC.
Now a collaborative effort among CDC, FDA, USDA, and all
50 States, PulseNet permits early and accurate detection
of food-borne illness outbreaks that in the past have often
gone undetected or were not recognized until they became
very large. PulseNet has been key in rapidly detecting and
containing numerous outbreaks of foodborne illness, including
multi-state outbreaks. For example, PulseNet aided in the
identification of a multi-state outbreak of Salmonella
Agona infections linked to toasted oats cereal. Since
the illnesses were dispersed among 20 States, the comparative
matching of the disease-causing organisms made possible
via PulseNet facilitated the epidemiological investigation
that led to the recall of two million pounds of contaminated
product. Without PulseNet, it is unlikely that these cases
would have been identified as coming from the same source.
Similar systems are now under development for viruses and
parasitic agents that produce foodborne illness.
eLEXNET. The electronic Laboratory Exchange
Network (eLEXNET), a seamless, integrated, secure network,
was developed by FDA to provide access to critical food
testing data in Federal, State, and local food safety laboratories.
eLEXNET has not only facilitated data information sharing
and communication, but has also provided a means for collaboration
among food safety experts. It has the potential to connect
the nationwide food testing laboratories and provide an
early warning notification system to identify potentially
hazardous foods and more quickly contain their distribution
To date, the eLEXNET system has been piloted with two Federal
laboratories, four State laboratories, and two local laboratories.
We are soliciting additional State and local participants.
The initial pilot covered Escherichia. coli O157:H7
but we are currently expanding it to cover three other pathogens
- Salmonella, Listeria, and Campylobacter.
Antibiotic Resistance. The National Antibiotic
Resistance Monitoring System (NARMS) was established in
1995 as an interagency cooperative activity between CDC,
FDA, and USDA to monitor emerging resistance to antibiotics
in foodborne pathogens, beginning with Salmonella.
Since its inception, new sources of isolates, an increased
number of isolates, and additional disease-causing agents
have been added to the system. NARMS facilitated the recognition
that Salmonella Typhimurium DT 104, a strain highly
resistant to antibiotics, was widespread in the U.S. This
prompted CDC to warn State health departments of its presence
and provide preventive steps to minimize its spread.
The most significant reduction in foodborne illness will
be achieved through the development and implementation of
successful prevention programs.
Hazard Analysis and Critical Control Point (HACCP).
HACCP systems represent a systematic approach to
the identification and control of the biological, chemical,
and physical hazards that are reasonably likely to occur
in a particular food in a particular production process.
There are a vast array of microbiological, physical, and
chemical hazards that have the potential to affect the safety
of foods. HACCP is a risk-based, food safety management
system that helps food manufacturers determine which hazards
are reasonably likely to affect their products and then
to develop safety assurance programs targeted to the specific
steps that must be controlled to safeguard consumers. Because
these systems are designed to identify and control microbial,
chemical, and physical hazards that are reasonably likely
to occur, they significantly reduce the risk that the final
product will contain hazards that could cause human illness
FDA implemented seafood HACCP in December 1997. It requires
all 4,100 seafood processors, covering 150 species of fish,
to implement complete HACCP systems. Now in its fourth year,
we are seeing across-the-board progress by the seafood industry
and we have implemented a "mid-course correction" to focus
that program where the public health issues are most significant.
This year, FDA also finalized HACCP regulations for fruit
and vegetable juices which will take effect next year. It
is estimated that this will prevent at least 6,000 illnesses
per year. FDA also has incorporated HACCP into its Food
Code, a guidance document that serves as model legislation
for state and territorial agencies that license and inspect
food service establishments, retail food stores, and food
vending operations in the U.S.
Good Agricultural Practices (GAPs). In
1998, FDA published a guide for growers and packers of fresh
fruits and vegetables. The "Guide to Minimize Microbial
Food Safety Hazards for Fresh Fruits and Vegetables" provides
science-based guidance to help reduce microbiological hazards
common to the growing, harvesting, washing, sorting, packing,
and transporting of fruits and vegetables. The guide addresses
key areas where precautions should be taken to ensure safety:
water quality, worker hygiene, field and facility sanitation,
manure management, and transportation. This guide was produced
in consultation with USDA and has been published in four
languages. Since its publication, the agencies have been
working together to educate the agricultural industry -
both domestically and internationally - on the recommendations
included in the guidance.
In 1999, in response to several foodborne illness outbreaks
associated with sprouts, FDA issued a warning to consumers
of the potential hazards associated with eating raw sprouts
and issued guidance documents for the sprouts industry.
These documents, "Reducing Microbial Food Safety Hazards
for Sprouted Seeds" and "Sampling and Microbial Testing
of Spent Irrigation Water During Sprout Production" advise
sprout growers and seed suppliers of the steps they should
take to reduce microbial contamination.
In addition to issuing the
guidance documents, last year FDA and the California Department
of Health Services produced and distributed an educational
video on good agricultural and manufacturing practices for
sprout producers. To assess the extent to which the sprout
industry is following the recommended practices, the Agency
issued a special assignment last year to inspect 150 sprout
producers. FDA is also working with academia and the sprout
industry on research to identify techniques to prevent contamination.
Bovine Spongiform Encephalopathy (BSE). HHS,
USDA, and other partners are working together to prevent
BSE from entering the U.S. BSE is a fatal disease that causes
progressive, neurological degeneration in cattle. It is
one of a family of diseases called transmissible spongiform
encephalopathies (TSEs). One TSE disease that affects humans
is Creutzfeldt-Jakob Disease (CJD). A form of this disease,
variant CJD (vCJD), appears to be related to the BSE disease
of cattle. There is strong scientific evidence that the
same agent that causes BSE in cattle is also the agent that
causes vCJD in people. So far, there have been cases of
vCJD reported in the United Kingdom and elsewhere in Europe,
believed to occur in people who consumed beef products contaminated
with the infective BSE agent. It is important to note that
there are no reported cases in the United States of BSE
in U.S. cattle or vCJD in Americans.
In January, HHS established an Interdepartmental Steering
Committee for BSE/TSE Affairs. I chair this committee which
includes representatives of FDA, CDC, the National Institutes
of Health (NIH), USDA, the U.S. Trade Representative, the
Office of Management and Budget, the U.S. Customs Service
(Customs), the Department of State, the Department of Defense,
the State Association of Feed Control Officials, the National
Association of State Departments of Agriculture, and the
White House Office of Science and Technology Policy. This
committee assures ongoing coordination between agencies,
integrated contingency planning in case BSE or vCJD is found
in the U.S., and coordination of risk communication plans
by the various agencies.
In addition, HHS is working closely with USDA in developing
a report that USDA will submit to Congress regarding actions
taken by Federal agencies to prevent foot and mouth disease,
BSE, and related diseases. This report will discuss the
economic impact, animal and human health risks, risk management,
and steps to strengthen safeguards against these diseases.
An essential element of ensuring the safety of the food
supply is the education and training of industry, Federal,
State, and local agriculture and health officials, and consumers
in prevention programs across the farm-to-table spectrum.
I have noted a couple of the educational materials developed
for industry - good agricultural practices for fresh produce
and guidance for the sprout industry to prevent contamination.
Enhancing school-based prevention
efforts to educate the next generation about food safety
is another important element. This month, in partnership
with the National Science Foundation, the Agency is launching
"Science and Our Food Supply," a curriculum for middle and
high school students that will instruct our youth in the
scientific principles of food safety and prevention. Also,
in collaboration with FDA and several states, CDC is leading
development of a model coordinated school health and food
An example of consumer education is the "Fight Bac" program
to prevent illness by raising awareness of potential hazards
in storing, cooking, and serving foods. This program is
part of the Partnership for Food Safety Education, a public-private
partnership that includes HHS, USDA, the States, consumer
groups, and industry. Consumer education efforts seem to
be paying off. Surveys of consumer behavior indicate that
more people are washing their hands and their cutting boards
to prevent cross-contamination between raw and other foods.
Fewer people are eating risky raw foods.
The foodsafety.gov web site, established in early
1999 by FDA in close cooperation with CDC and USDA, is visited
an estimated 40,000 times each month. The site has information
for consumers, industry, health professionals, food safety
educators, and others. To raise
awareness and educate heath professionals, HHS and USDA
also collaborated with the American Medical Association
to develop a physician education program on the diagnosis
and management of foodborne illness.
Research and Risk Assessment
Research and risk assessment are critical to ensuring the
strong scientific basis necessary for our regulatory programs
to be effective. The Department must be able to keep pace
by learning more about foodborne diseases and their causes
and by developing new scientific methods for detecting and
preventing foodborne hazards. A strong science base is a
prerequisite to meeting the food safety challenges and to
maintaining our leadership role both nationally and in the
new global economy.
In 1999, HHS and USDA created the Joint Institute for Food
Safety Research (JIFSR). JIFSR coordinates planning and
priority-setting for food safety research across government
agencies and with the private sector. This coordination
optimizes food safety research investments, channels Federal
resources to research priorities, and helps avoid research
redundancies. JIFSR also seeks to foster the effective translation
of research results into practice along the farm-to-table
HHS has been a leader in food safety research and maintains
technical expertise in a wide range of disciplines that
affect the safe and wholesome production, packaging, and
formulation of foods, dietary supplements, and cosmetics.
FDA leads international standard setting efforts in food
hygiene, food labeling, bioengineering of foods, and chemical
contaminants. While FDA maintains a strong research and
risk assessment program, the diversity and types of scientific
expertise and knowledge are ever-expanding. Consequently,
FDA recognizes it must leverage both academia and industry
expertise as well and has done this through three cooperative
agreements or consortia. The National Center for Food Safety
and Technology (NCFST) at the Illinois Institute of Technology
is devoted to research and evaluation of better food processing
and packaging technology. The Joint Institute for Food Safety
and Nutrition at the University of Maryland is devoted to
risk assessment, agricultural practices and education, such
as international Good Agricultural Practices training programs,
and establishment of the Center for Risk Analysis and clearinghouse
for risk assessment. The University of Mississippi has a
collaborative program to work in the area of the safety
of dietary supplements. FDA will work to strengthen these
existing collaborations and will develop additional partnerships
with other universities that have strong food safety research
FDA has also strengthened its scientific foundation through
extramural research grants to support research in the areas
of BSE, produce safety, egg safety, HACCP system validation,
food service or retail practices, and consumer practices.
Examples of such projects include the development of simple,
reliable methods for extraction and detection of viruses
from a variety of food products, research to improve produce
safety by developing and applying novel non-thermal food
processing technologies, and the development of improved
sampling and detection methods of low levels of Salmonella
Enteritidis in eggs.
CDC conducts a limited amount
of applied research, particularly to understand and optimize
public health practice for the prevention and control of
diseases. Examples include efforts to develop assays for
detecting and subtyping foodborne pathogens for which adequate
testing methods do not currently exist; identify the causative
agents for foodborne outbreaks of unknown etiology, as well
as pathogens responsible for sporadic cases of foodborne
illness; evaluate new strategies for reducing illness; and
identify behavioral and other risk factors associated with
foodborne disease. In
also conducts scientific
research on the health effects and genomics of foodborne
Improved Protection for Imported Foods
The increasingly global nature of the portion of the food
supply that FDA regulates presents significant challenges.
To help keep unsafe foods out of U.S. markets, FDA works
closely with Customs. FDA and Customs have established a
procedure to prevent the distribution of unsafe imported
food by requiring that shipments from "bad actor" importers
be held in a secure storage facility at the importers' expense
until released by FDA. FDA has also established procedures
to enhance interagency coordination and to efficiently use
Customs' civil monetary penalties procedures against importers
who attempt to enter food into the U.S. by means of a material
false statement, act, or omission. In January, FDA published
a proposed rule to require marking food shipments refused
entry for safety reasons to deter the practice of "port
shopping" in which importers whose cargo is denied entry
at one port attempt to re-introduce it at another port.
FDA has also led a series of food safety workshops literally
around the world in Central America, South America, the
Southern Pacific region, Asia, and Africa. These workshops
educate foreign governments and food producers on the food
safety standards needed to meet U.S. requirements.
In addition, CDC has increased its efforts to build investigative
capacity throughout the world and to expand systems such
as PulseNet globally in order to rapidly identify international
outbreaks. CDC is working in these areas in collaboration
with the World Health Organization.
As stated earlier, HHS is committed to building a strong
and credible food safety system. We must enhance our ability
to identify risks, take action, and measure results. Specifically:
- To enhance our ability to identify risks, we
must strengthen our science base. We need to expand the
FoodNet, PulseNet, and eLEXNET programs, described earlier,
and assess adequate detection and response capacity in
every State. Existing collaborations with our academic
and private sector partners need to be strengthened and
new partnerships need to be forged.
- We need to take action to make improvements in
inspections of domestic and imported foods. The Agency
has redirected its field force to perform annual inspections
of firms that produce foods at highest risk for microbiological
contamination. FDA is working to enhance the infrastructure
and capabilities of the field laboratory to increase the
number of sample analyses of both domestic and imported
foods. To help ensure that imported foods meet the same
level of consumer protection as domestic foods, HHS is
seeking to increase its overseas presence and is providing
technical assistance to foreign countries.
- We will continue to measure results to ensure
that the food safety activities are effective.
Thank you for the opportunity to discuss our food safety
program and our continued efforts in this area. We look
forward to working with the Subcommittee on ways to continue
to improve the safety of the nation's food supply. I would
be happy to answer any questions.
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Last revised: November 6, 2001