Remarks prepared for delivery by Food Safety and Inspection Service Administrator Alfred Almanza to the Food Safety Summit, April 28, 2009, in Washington, DC

Notes: Slides are available in an attached PDF document; individual pages are linked within the text.

Introduction

(Slide 1) I'd like to start by thanking my colleagues on the panel, as well as Laurie Lehman, Director of Education for the Food Safety Summit, for her hard work to organize this session.

Events like this Food Safety Summit are important because they bring all of us together, farm to fork. They remind us that we have a common goal of producing a safe and wholesome food supply.

I hope everyone has their seats belts handy—buckle up—this is going to be a bumpy ride!

Future of Federal Food Safety

Our new president is committed to looking at the entire food supply, across products and across jurisdictions. Agriculture Secretary Tom Vilsack is open to considering single agency food inspection. I think the President and Secretary should be commended for taking on this difficult task of reviewing the current state of our food safety system and making it a top priority.

We all need to look at the various levels of risk posed by different food products and the different performance of the establishments that manufacture those food products.

We need to ask hard questions about what level of inspection is appropriate for different kinds of foods, what roles are appropriate for the different agencies involved in food safety, and how we approach uniformity in import safety.

The way the future system is structured will unavoidably affect you and your industry. It is still too early to tell exactly how, but there is a finite amount of federal resources and this exercise will determine how these funds are allocated. I can't emphasis enough how important it is to make sure risk, hazards and performance are taken into consideration in this process.

FSIS: A Public Health Inspection Agency

(Slide 2) At FSIS, our goal is to develop into a model public health inspection agency.

We have spent the last three years building a system that supports the appropriate and effective allocation of resources within our inspection system. We inspect. It is who we are. It's what the public demands and the law requires. Yes, we are public health-oriented, but pure and simple; we are an inspection agency.

Inspections don't disrupt business. They're part of doing business and allowing business to thrive.

Science and data will drive our decisions, including:

• Risk assessments and data analysis (e.g. Listeria);
• Public input (e.g. public meetings with industry representatives, consumers and other public health partners); and
• Baseline studies (e.g. Salmonella).

We understand inspection is a science, not an art.

Risk-based inspection allows our agency to place resources where they do the most good. This approach was independently endorsed by the National Academy of Sciences.

I know what works.

And the CDC released a report stating that our efforts to reduce Salmonella and other pathogens are working.

The bottom line is that consumers—including each of us—want to know that our food is safe. FSIS makes each public inspection decision with this in mind.

If our food safety decisions are based on data, we must ensure that the data we use are reliable. To achieve this, we are building a dynamic data system called the Public Health Information System, or PHIS. It will be predictive, analytic and will alert us to changing and emerging food safety trends. More on this later…

More Than a Decade of HACCP

(Slide 3) As many of you know, the laws governing how we regulate food safety for meat, poultry and processed egg products are different than the laws governing other foods. For example, our laws require mandatory inspection.

Meat and poultry establishments have been under the Hazard Analysis and Critical Control Point system, or HACCP, for over a decade, and we are in a better place for it.

We've learned some important lessons along the way about regulating a system that makes operators responsible for control and responsibility of their processes, ensures that food safety is built into an establishment's system and moved us away from 'command and control' inspection.

Lessons Learned From HACCP

Lesson 1: Workforce Training and Development
(Slide 4) One of the things we found early on in the development of HACCP is that training field inspection personnel was essential to monitoring and enforcing HACCP.

We created Consumer Safety Officers, or CSOs, in 2002 who:

• Conduct Comprehensive Food Safety Assessments; and
• Assess the design and overall execution of the entire food safety system.

We expanded CSOs into Enforcement, Investigations and Analysis Officers, or EIAOs, who:

• Document administrative enforcement case files;
• Conduct recall effectiveness checks; and
• Investigate consumer complaints.

We also created the Food Safety Regulatory Essentials Training Program in 2003, for Consumer Safety Inspectors, or CSIs. The program:

• Ensures competence in verifying SPS, SSOP and HACCP regulatory requirements, and in following the Rules of Practice; and
• Has been a "condition of employment" for employees newly hired or promoted as CSIs since 2004.

Lesson 2: Supporting Enforcement Decisions
(Slide 5) We also learned the importance of supporting enforcement decisions. In 2004, FSIS instituted the Administrative Enforcement Reporting system which provided a more structured approach to documenting and supporting enforcement decisions and actions in accordance with the FMIA, PPIA and the Rules of Practice.

This system has strengthened the Agency's ability to defend its enforcement decisions when challenged, and ensures due process entitlements are provided to the establishments subject to enforcement actions. This strengthened FSIS' ability to support enforcement cases that were based on a conclusion that the food safety system was inadequate.

Lesson 3: Fighting Major Pathogens using HACCP
E. coli O157:H7
(Slide 6) E. coli O157:H7—which I'll refer to simply as E. coli for the rest of this presentation—was a major problem in the beginning of this decade. There were a number of major recalls in 2002 and 2003. In response, FSIS used HACCP regulations to require all establishments to reassess their HACCP plans.

New research showed that the occurrence of E. coli on animals entering the slaughter process was higher than previously thought, so the Agency expressed its view that E. coli is a "hazard reasonably likely to occur" in the beef industry.

Many firms responded positively. Large slaughter plants dramatically increased their testing for the pathogen. And for a while, it looked like establishments were gaining the upper hand on E. coli. We were finding it at a low frequency, less than our goal, and the rate of human illness from E. coli actually met the Healthy People 2010 goal in 2004.

Unfortunately, E. coli is a crafty bug. It has come roaring back over the last few years. A lack of attribution data has made it hard to find the source of the problem, but there is no doubt that we are finding this pathogen almost twice as frequently as we had been four years ago.

Even so, HACCP positions the Agency and industry well to deal with this changing problem. Many in industry recognized that E. coli is addressed most effectively in slaughter plants and have started to rely on prerequisite programs to prevent the occurrence of E. coli in their operations.

There's still a problem, though. Many plants seem to think that once they set up the prerequisite program, their work is done. It is not. They are obligated to verify the ongoing effectiveness of a prerequisite program in the same way they are required to verify ongoing effectiveness of a CCP.

We are engaged in a constructive dialogue to help plants—particularly grinding plants—understand and fulfill their responsibilities.

Listeria monocytogenes
(Slide 7) The story is better with Listeria. In 2003, FSIS issued an interim final rule announcing that Listeria is a hazard "reasonably likely to occur" in ready-to-eat food products. The Agency outlined three ways establishments can address Listeria in their HACCP plan.

The result? Plants have generally strengthened their programs, and human illness levels from Listeria have hovered at a level around the Healthy People goal for the last four years. But we're not becoming complacent; FSIS is learning to use our EIAOs even more effectively to assess whether establishments maintain control over Listeria.

Salmonella
(Slide 8) The third major pathogen is Salmonella. Our efforts to use HACCP against this pathogen suffered a blow eight years ago when a court ruled that our performance standard for Salmonella in ground beef is not legally enforceable. But HACCP still manages to provide useful tools to fight the pathogen.

HACCP focuses on an establishment's control of its process, and we have used the performance standard to measure process control. In 2006, we set a goal to have 90 percent of poultry slaughter plants exercising excellent process control by 2010. At the time, only a little more than half were doing so.

Today, I'm happy to report that over 80 percent of poultry slaughter plants are achieving this level of control. And we are optimistic that the industry will achieve this goal. We lag in achieving the human illness goal set out in Healthy People, but we believe we are on the right track.

Summary of HACCP Lessons Learned
(Slide 9) So, the story of the first decade of HACCP, is the story of how FSIS and industry learned to use the flexibility of HACCP. Establishments learned how to develop more effective processes, and FSIS put a more effective, ongoing verification system in place.

We have learned that if all inspection tasks are not performed, conditions in a plant can slowly slide out of control. And the loss of control only becomes obvious when product from the plant is released into commerce, and then must be recalled.

We have learned that trends in HACCP data can be difficult to spot. And that it's often challenging to put together different findings to see that a trend is developing.

Implementation of HACCP continues to evolve; but we are confident in this system-based approach. Over a decade later, HACCP is changing, but still effective.

We are taking these 'lessons learned' and using them to develop the PHIS system I mentioned earlier.

PHIS

(Slide 10) PHIS is a project that FSIS is excited about. It's an information and monitoring system.

The system is being designed to:

• Alert inspectors to dangerous food processing trends;
• Rapidly detect and respond to everything from pathogen outbreaks and unsafe practices to widespread violations;
• Better coordinate with managers, stakeholders and other agencies while improving investigations and adulterant tracing; and
• Enter, coordinate and store information in centralized data warehouse.

Information will be constantly monitored, compared and assessed for unsafe patterns and anomalies that could spell trouble. Inspectors can take immediate action.

Establishments will be placed into a three-tiered structure.

The system is expected to be working by October 2010.

Closing

(Slide 11) We are partners in food safety. FSIS is evolving to be the best at our job in the food safety system.

And we continue to provide information through our publications, podcasts, regulatory education sessions and other outreach efforts to help FSIS personnel and state employees, industry and consumers do their part.

Thanks for your time, and I welcome any of your questions at the end of the panel.