Remarks prepared for delivery by USDA Under Secretary for Food Safety Dr. Richard Raymond, at the ARS-FSIS workshop, on March 7, 2006, in Annapolis, MD..

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

Introduction
(SLIDE 1)
Thank you and good afternoon. I appreciate this opportunity to speak with you today about our efforts to combat Salmonella and lay the foundation for a more robust risk-based inspection system.

I often talk about how there are science-based solutions to nearly every food safety challenge that we face today. I want to ask everyone here a favor, please don't make me a liar!

(SLIDE 2)
This year marks the 100th anniversary of the passage of the Federal Meat Inspection Act. The Act ushered in a new era of food safety on a national level, but after a century its age is beginning to show.

It was based on visual examination for visible signs of disease. The future demands that we be able to focus on the things which the human eyes cannot see, the human nose cannot smell, and that our fingers cannot feel.

Your future research, insight, and effort will be critical to ensuring that our food safety system will be able to meet these demands in the next century.

That is why I believe strengthening FSIS' relationship with ARS, and for that matter all of our research partners, is critical to our future success.

Simply put, FSIS' food safety regulatory policies are built upon the strong foundation provided by your scientific data. A foundation that has been strengthened by the contributions of the National Alliance for Food Safety and Security (NAFSS).

In 2005, FSIS, ARS, and NAFSS developed, funded and conducted an important nationwide risk-assessment on Listeria monocytogenes in ready-to-eat luncheon meats. This study will be critical to determining FSIS' future actions to combat this dangerous pathogen.

Our relationship with ARS has only gotten closer since Dr. Merle Pierson became the Deputy Under Secretary for Research, Education and Economics. I cannot think of anyone better for that job.

For three and a half years, Dr. Pierson served as Deputy Under Secretary and then Acting Under Secretary for Food Safety. He knows our issues and challenges inside and out. He also knows where the research money is, which might prove dangerous.

I want to also recognize the important contributions made by researchers from the CDC and FDA. Their efforts have helped make the Foodborne Diseases Active Surveillance Network an essential public health tool. Together we are making great strides toward being able to link foodborne illness estimates to specific food vehicles. This will prove to be a tremendous asset as we work to further protect the nation's food supply

Recent Successes
(SLIDE 3)
Thanks to the tools you have provided us, we have seen dramatic declines in the prevalence of pathogens in the products that we regulate and the numbers of foodborne illnesses stemming from these pathogens.

(SLIDE 4) | (SLIDE 5) | (SLIDE 6)
Another significant measure of how our science-based policies and control measures in plants are affecting public health can be found in an annual report published by the CDC.

According to the CDC, there have been significant declines from 1996 to 2004 in illnesses caused by E. coli O157:H7, Listeria monocytogenes, Campylobacter, and Yersinia.

(SLIDE 7)
Compared to the 1996-98 baseline, illnesses caused by E. coli O157:H7 decreased by 42 percent. I am happy to report that we met the Department of Health and Human Services' Healthy People 2010 objective for E. coli O157:H7 six years early.

In 2004, the CDC reported .9 cases of E. coli O157:H7 infections per 100,000 people. This is lower than the Department of Health and Human Services' Healthy People 2010 objective of one case of E. coli O157:H7 per 100,000 people.

(SLIDE 8) | (SLIDE 9) | (SLIDE 10)
Taken together these human health results and decreasing numbers of pathogens in our sampling program indicate that our risk-based approach is working. However, you deserve to share some of the credit for these successes. After all, it was your dedication and research that made our science-based approach possible.

All of this is good news, but we still have areas of concern. Areas that can benefit from your work.

Salmonella
(SLIDE 11)
A specific and critical concern is Salmonella. When FSIS reported its 2003 data, the Agency acknowledged that the percentage of positive Salmonella tests had increased slightly in all three poultry categories. While the 2004 data showed more mixed results, there was a continued increase for young chicken (or broiler) carcasses, and that number rose again in 2005.

The four-year trend of rising rates on broiler carcasses does not bode well for the public's health. It has risen nearly 50 percent in just three years, and you do not have to be a food scientist to know that this is not a positive development.

The CDC's most recent FoodNet report is not much better. It is clear that the overall incidence of Salmonella infections remains far above our objective. In 2003, there were 14.5 cases of Salmonella infections per 100,000 people. That's 43,500 people per year with culture proven Salmonellosis.

The CDC estimates that the actual number could be over one million. That is a tremendous burden on human health.

(SLIDE 12)
While CDC did report that Salmonella infections dropped eight percent, only one of the five most common strains, which account for 56 percent of the reported Salmonella infections in 2004, declined significantly. That strain was Salmonella Typhimurium which declined 38 percent.

Salmonella Enteritidis and Salmonella Heidelberg neither increased nor decreased significantly. Incidences of Salmonella Newport increased by an alarming 41 percent.

Given the challenge we face with Salmonella, it is imperative that we take a risk-based approach to investigating and controlling the incidence of Salmonella in meat, poultry and egg products. An approach that will be based upon your scientific research.

I believe that we can leverage new technologies and cutting edge research, not only to reach the Healthy People 2010 objective, but to drive the numbers even lower.

(SLIDE 13)
Since the prevalence rate in broiler chickens seems to be a trouble spot, we are revising the performance measure for Salmonella on this particular product. This is in part due to three weaknesses we have identified in the current measure.

The first one is that the measure is scientifically unsound. The FSIS regulatory testing program that is the source of the data used in the current performance measure does not provide a true measure of prevalence of the pathogen.

For example, if samples from an establishment are only taken early in the first shift, then those samples are not providing us with an accurate understanding of the environment, or workforce's characteristics of that establishment's second shift.

The second weakness is that the current measure is for generic Salmonella, and includes serotypes that are not, or are rarely attributed to foodborne illness. There are many known serotypes of Salmonella found in broilers. Each serotype cause human illness with varying severity. In fact, the most common has been found not to be a significant factor in human foodborne illness.

The third weakness is that the current testing program is not consistent with FSIS' goal of transitioning to a more robust risk-based inspection system.

To generate the data needed to report on the current measure, FSIS would need to continue scheduling a sample set for every plant each year under the current strategy. But plant process controls for Salmonella vary widely, as do their results.

Since 2003, aggregate percent positives in sample sets have increased each year from 11.5 percent in 2002, to 16.3 percent in 2005 while still remaining within regulatory performance standards. In order to improve program performance, FSIS is working to strengthen its verification testing program by making it more risk-based.

(SLIDE 14)
The image on the screen illustrates an analysis of 103 large broiler plants where FSIS completed five or more HACCP verification sets from 1998-2004.

Twenty-six of the 103 establishments (25%) routinely demonstrated Salmonella control, with six or fewer Salmonella positive tests out of 51 tests per set. Another 46 establishments (45%) exceeded half the standard without failing at least once and another 31 (30%) exceeded the standard at least once.

You can see that a substantial number of the plants were below 50 percent of the existing performance standard on every set. If those plants can accomplish it then we believe others can do the same.

(SLIDE 15) The plants that fail one or more sets, and the plants that fluctuate above and below 50 percent but never fail, will frequently have a set where they perform very well.

This helps to explain why we find that the majority of set results are below 50 percent of the existing Salmonella prevalence standard. Even with 35 percent of the analyzed establishments failing one or more sets, less than 25 percent of those sets were above the standard.

We know that lowering the prevalence of Salmonella in poultry products is possible. We have seen one plant with a Salmonella prevalence rate of 30 percent reduce that rate to 2 percent after a food safety assessment. Our goal as we move forward must be to make these reductions a reality across the board.

The Agency has also found strong evidence that plants that have consistently achieved a percent positive rate in sample sets at or below half the current regulatory performance standard are less likely to produce raw product that have the serotypes of Salmonella that are causes of human illness.

As a result, achievement of performance goals established under the new measure would provide a better indication of process control and relate more directly to the improved safety of broilers.

Nearly two weeks ago, we announced an initiative to reduce Salmonella in meat and poultry products. It incorporated 11 steps, including increased sampling in plants where it is most needed and quarterly publication of nationwide Salmonella data by product class.

The initiative uses the old carrot and stick approach to encourage change by offering establishments the possibility of improved efficiency, incentives, and also disincentives based on their progress. I am not going to get into the specifics of our 11-point plan, today. After all that is why we keep people like Dr. Patricia Bennett on the payroll. She will be detailing our new initiative tomorrow. However, I am confident that this initiative will help FSIS to be pro-active and take action before people get sick.

Robust Risk-based Inspection Systems
(SLIDE 16)
FSIS must develop these critical abilities further and that is why it is so important that we begin to lay the foundation for a more robust risk-based inspection system.

I want to focus our time and valuable resources on prevention, rather than on response. Command and control was the old agency mantra. We are now after a common sense, cost-effective public health strategy that best serves the American consumer by preventing human illness.

I did not take this job to recall ground beef, ready-to-eat chicken tenders and sausage. As a doctor, I want to prevent contamination and reduce the number of people getting sick each year. I want to focus on prevention.

I know with your continued support, we can further improve upon the food safety successes that we have already seen.

Our current system, while strong, is not suited to the future realities of food safety and public health, and we will need the ability to anticipate and quickly respond to food safety challenges before they negatively affect public health offered by an enhanced risk-based system.

This is vital, as is a system that will allow us to use our finite resources more effectively and efficiently to further improve food safety.

However, it is important to note that FSIS already uses a risk-based approach to food safety. Our goal is to further enhance and strengthen that system so that we are prepared for the food safety challenges in the next century. The research that you conduct will be crucial to this effort.

To continue our progress toward a fully implemented risk-based inspection system, we need to be sure that we communicate openly and often with all of our food safety stakeholders. I assure you that we will use a transparent and inclusive process to seek input on a wide range of issues related to creating a more robust risk-based inspection system.

At the last meeting of the National Advisory Committee on Meat and Poultry Inspection (NACMPI) in November, the Committee recommended a third-party approach to assist us in reaching out to, and gaining input from, our stakeholders.

We are now in the process of selecting a neutral third party and a subcommittee of NACMPI has been established to provide regular, ongoing guidance. I urge everyone here to take an active role. Your experience and knowledge is invaluable.

We all know that we can save lives through sensible science-based policies, and together I know we will do just that.

Closing
Before I close, I want to remind you that we have a strong system in place. But we must continue to improve and enhance our food safety system. A system not moving forward is a system falling behind. Mother Nature is always changing, and we must change along with her.

Remember, the state of public heath is constantly evolving. It is your responsibility to ensure that whatever that next evolution is that it will be grounded in science.

The entire history of public health is really just a long list of achievements that were at one time thought impossible. The work of dedicated scientists like you ensures that the impossible will eventually become commonplace given enough time.

(SLIDE 17)
Did you know that 100 years ago, 1 in 5 coffins contained a child under 5 years old? Today that number is only 1 in 100 coffins. That is an amazing accomplishment that has had a profound impact on our society and everyone in this room.

Clean water, sewage, vaccines and antibiotics — but a safe food supply has also played a role in this amazing phenomenon.

I know that together we can continue to lower the number of deaths.

(SLIDE 18)
After all, the bottom line is that we all have the same objectives - safe food and healthy people. We must never lose sight of these common goals.

Thank you again for your time and I look forward to seeing the research that will flow from this strong collaborative relationship.