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.

Introduction

Good afternoon. It is a pleasure to be here at the Food Safety World Conference and Expo and to be with my colleagues from FDA.

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 Act.

While I have not been at it quite 100 years… Fulfilling this public health mandate remains a demanding responsibility as well as an exciting challenge.

Presentation Overview
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 accomplishments.

Second, I want to talk about some priorities for 2006, including enhancing our risk-based inspection systems and risk-based pathogen controls.

FSIS Priorities

Two years ago, we outlined a series of priorities to better understand, predict and prevent the contamination of meat and poultry products. They are:

1. Continuing Evolution of Inspection and Enforcement;
2. Training, education and outreach;
3. Food Defense;
4. Risk Analysis;
5. Management Controls and Efficiency; and
6. 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 health protection.

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 health.

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 inspection system.

Food Defense
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 a must!

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.

Risk Analysis
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 surveillance program.

Accomplishments

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.

Regulatory Sampling
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.

CDC Information
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 inspection system.

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 system.

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 be supported.

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 protection.

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 way possible.

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 controls.

Lm Control
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.

Salmonella Control
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 hazards.

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 control.

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 protected.

Closing

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 inspection system.

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 you.