Remarks prepared for Dr. Barbara
J. Masters, Administrator, Food Safety and Inspection Service,
at the Food Safety World Conference and Expo on March 9, 2006,
in Washington, DC.
Good afternoon. It is a pleasure to be here at the
Food Safety World Conference and Expo and to be with my colleagues
Hundred Years Perspective
For over a century, American consumers have depended
on the U.S. Department of Agriculture to ensure the safety of
their food supply.
In fact, 2006 marks the 100th anniversary of the passage of
the Federal Meat Inspection Act, which ushered in a new era
of food safety on a national level. The agency will be commemorating
our rich history later this year. It is exciting also that it
is the 100th Anniversary of the Federal Food Drug and Cosmetics
While I have not been at it quite 100 years
public health mandate remains a demanding responsibility as
well as an exciting challenge.
Today, I would like to focus on two main areas. First, I will
outline some of the Agency's successes, including accomplishments
in the areas of FSIS' top priorities and significant food safety
Second, I want to talk about some priorities for 2006, including
enhancing our risk-based inspection systems and risk-based pathogen
Two years ago, we outlined a series of priorities
to better understand, predict and prevent the contamination
of meat and poultry products. They are:
- Continuing Evolution of Inspection and Enforcement;
- Training, education and outreach;
- Food Defense;
- Risk Analysis;
- Management Controls and Efficiency; and
- Public Health Communications Infrastructure.
Even though our priorities remain the same, the outcomes we
expect in each of these areas are changing. We are constantly
raising the bar so we can move forward to further enhance public
I will not go through each of these priorities individually
but will mention a few key accomplishments.
Public Health Communications Infrastructure
I'd like to mention something about the public health
communications infrastructure, as we are constantly looking
for ways to improve communication within FSIS and between the
agency and its stakeholders, as well as cross-agency communications.
We are working closely with other federal agencies to improve
the management of information technology. We need to work together
and share surveillance and monitoring data for public and animal
We recognize that data systems that allow us to assess data
to respond in real time to public health information help build
the infrastructure that is needed for a more robust risk-based
Next I want to mention food defense. The agency has
also accomplished much in the area of food defense, making a
strong system even stronger. We will continue our substantial
efforts to improve our food defense capabilities.
We continue to assess the vulnerabilities in the food supply.
The Strategic Partnership Program on Agroterrorism, a program
including the FBI, FDA and Department of Homeland Security along
with FSIS and other USDA agencies, carries out joint vulnerability
assessments on the food supply with industry and States.
The Food Emergency Response Network (FERN) is a vital component
of our food defense infrastructure. We have been working closely
with FDA to get national, state and local laboratories closely
integrated to be able to handle numerous samples that would
be required to be tested in the event of an attack on the food
supply, a natural outbreak or even a hoax. Surge capacity is
And at the in-plant level, we have worked closely with the
industry to voluntarily adopt food defense plans. We have model
plans available and held workshops on how to develop a plan.
Our risk analysis goal — which includes risk assessment,
risk management and risk communication — is an extremely important
process, one that provides us with a way to focus resources
on hazards that pose the greatest risk to public health. And
for economically significant regulations we are required to
conduct risk assessments.
For example, with our interim final rules on specified risk
materials, we have contracted with Harvard University to update
our risk assessment on BSE to ensure that our measures implemented
through the interim final rules were appropriate.
We are drafting a final rule based on the comments received
on the interim final rules, the results of the updated peer
reviewed Harvard Risk Assessment and results of USDA's enhanced
In addition to our accomplishments in the area of our agency
priorities, we have had a number of food safety successes over
the past few years.
One such success is apparent in our regulatory sampling for
E. coli O157:H7 and Listeria monocytogenes.
The results from our microbiological surveillance
testing program for E. coli O157:H7 show that we have gone from
.84% positive in CY 2001 to only .17% positive in CY 2004.
Our testing for Listeria monocytogenes (Lm)
in all ready-to-eat (RTE) products shows similar progress. Compared
to a decade ago before HACCP was implemented, we have made substantial
progress in Lm control, as these statistics from our
RTE sampling program indicate:
- In 1995, 3.02 percent tested positive.
- In 2004, .55 percent tested positive.
In addition to regulatory data on products, we are
seeing similar trends in how public health is impacted. This
gives us confidence that the combined efforts of the Agency,
industry and consumer education are on the right track, as evidenced
by the decline in foodborne illness over the last seven years.
It is not new news, but certainly worth repeating. Last spring,
the Centers for Disease Control and Prevention (CDC) reported
continued reductions in foodborne illnesses from 1996 through
2004 stemming from E. coli O157:H7, Listeria monocytogenes,
Campylobacter and Yersinia.
The report indicated that recent reductions in foodborne illness
are not an isolated event and that sustained progress is being
made toward reducing illness from very dangerous foodborne pathogens.
However, progress needs to continue in order to stay ahead
of these pathogens as they evolve and present new challenges.
Priorities for 2006
This leads me to some of the Agencies priorities for this year
— risk-based inspection systems and risk-based pathogen controls.
A More Robust Risk-Based Inspection
What is risk-based inspection? We are taking a dramatic step
forward to improve food safety and support Under Secretary for
Food Safety Dr. Richard Raymond's vision of a more robust risk-based
Dr. Raymond likes to describe this risk-based system
as a stool with three legs — with each leg representing consumers,
employees and industry respectively. Each leg provides vital
support so the stool doesn't collapse — hence our risk-based
FSIS' goal is to build the infrastructure that is necessary
to support our vision. Let me illustrate how we'll provide the
critical infrastructure so that the "three-legged stool" can
The foundation of this structure contains the steps toward
full implementation of a risk-based system — starting with HACCP,
then HIMP, then risk-based Listeria verification sampling,
and so on until we achieve a more complete risk-based system.
However, before we can talk about these steps, especially the
ones that are not yet even known, we need to conceptually understand
a risk-based infrastructure.
We must keep in mind what we want out of a more robust risk-based
system. Let me use another analogy. Think of risk-based inspection
as a pinnacle. The pinnacle provides comprehensive public health
Supporting this pinnacle are the three pillars — one each for
regulated industry, FSIS Personnel and Consumers.
Industry Pillar - We need to ensure
that the regulated industry designs and implements effective
food safety systems. HACCP is the core of this, and all plants
need to have properly functioning HACCP systems.
Each establishment must enforce the maintenance and effectiveness
of the Sanitation SOPs and sanitation performance standards.
They must understand the interdependence of all the systems.
One of our priorities this year is to work steadily to improve
our outreach efforts to small and very small plants. We conducted
several outreach sessions last year, and will continue with
significant outreach activities this year.
FSIS Personnel Pillar - Under this
pillar, we need to collect, assess and respond to public health
data. Our verification must be uniform and consistent, especially
in the areas of greatest risk.
In a more robust risk-based inspection system, FSIS will also
conduct an assurance function to verify whether or not the agency's
policies have corrected what our assessments identified.
Under an optimal risk-based inspection system, the type and
intensity of inspection activity at each plant would be determined
by an analytical process that allows our inspectors to foresee
problems so they can focus their efforts on plants and processes
that pose a public health risk.
As I mentioned previously, we'll need an enhanced data system
that will allow us to collect, assess and respond in real-time
to public health data.
Consumers Pillar - In this pillar,
consumers — as each and every one of us here are — need to have
confidence in a safe and secure food supply.
We recognize that each step taken toward a more robust risk-based
system must further protect public health. Our goal is to ensure
that we receive input from all stakeholders along every step
of the process.
The Need for a More Robust Risk-Based Inspection System
A more robust risk-based inspection system will ensure that
our agency's resources are used in the most effective and efficient
We need to enhance our risk-based inspection systems to help
us face future food safety challenges.
We will be using a third-party facilitator to assist us in
gaining input from all our stakeholders and look forward to
your input. The NACMPI has a subcommittee that has assisted
us in the development of a Statement of Work for obtaining the
third party. We will be going out for bid for the contract on
the third party soon.
Risk-based Pathogen Controls
Another major issue in 2006 is risk-based pathogen
Our Listeria monocytogenes verification sampling is
a good example of how we have taken a more risk-based approach
in processing plants.
Under this initiative, FSIS tailors its verification activities
to the interventions that plants choose to adopt and to the
potential for Lm growth in their products.
In other words, we conduct less sampling in those plants that
have the best Lm control programs and more sampling
in plants that adopt less vigorous programs. Thus, plants have
an incentive to do more to control Lm.
For 2006 we will be taking this program to the next level.
We will begin selecting plants based on risk to conduct what
we call Intensified Verification Testing. This includes environmental,
product contact and product sampling for Listeria —
but also includes a Food Safety Assessment to evaluate the design
of the food safety system for controlling Listeria.
Look for information on this program within the month.
Considering all the progress that has been made in
reducing Listeria monocytogenes, E. coli O157:H7,
Campylobacter, and other pathogens, we believe it is
time to enhance the risk-based approach to investigating and
controlling the incidence of Salmonella in meat, poultry,
and egg products.
Salmonella is the most frequently reported foodborne
illness in the United States, causing culture proven cases of
foodborne illness at a rate of 14.5 per 100,000 population.
The Department of Health and Human Services' Healthy People
2010 calls for a rate of Salmonella infections of 6.8
per 100,000 population. We have a long way to go.
While FSIS responds quickly to positive findings of Salmonella
linked to human illness at any establishment, our risk-based
Salmonella approach for raw product would help us be
proactive before human illness is associated with our regulated
products rather than be reactive.
We have already started the foundation work for
a risk-based Salmonella approach. We held public meetings
to work with our stakeholders to find ways to reduce food safety
Last August, for example, we held a public meeting on Advances
in Pre-Harvest Reduction of Salmonella in Poultry in
Athens, Georgia. We focused on research and practical experiences
aimed at reducing Salmonella at the poultry production
level, or before poultry reaches Federally-inspected plants.
Based on input from that meeting and other information available
to us, we are developing compliance guideline materials for
producers that address pre-harvest food safety and Salmonella
We held a second public meeting last month in Atlanta, Georgia
and outlined new approaches to in-plant controls for Salmonella.
This document is available for public comment.
We presented the latest data and unveiled our strategy for
reducing the prevalence of Salmonella. We will be concentrating
our resources at plants with higher levels of Salmonella
and change the reporting and utilization of our Salmonella
verification test results.
Much of this new effort is patterned after our E. coli
O157:H7 initiative a few years ago, which has led to a 40% reduction
in human illnesses associated with the pathogen.
Changes WILL be made to the way that we approach the issue
of reducing the prevalence of Salmonella in poultry.
These changes must occur to ensure that public health is further
We recognize that addressing the challenges and
working toward our priorities will require an even stronger
partnership with all of our stakeholders.
We still have a long way to go to meet the Healthy People 2010
goal for Salmonella and will be making changes to ensure
that public health is further protected.
We will also be taking steps to provide more comprehensive
public health protection by developing a more robust risk-based
We appreciate the important role you have played in making
our food supply safer, and we need to ensure this progress continues.
We need your buy-in and support to achieve these goals. Making
certain that the nation's food supply is safe makes good business
and good public health sense.
We appreciate your commitment to our mutual goal of protecting
the food supply, and we look forward continuing to work with