Prepared remarks for USDA Under Secretary for Food Safety Dr. Richard Raymond, to be delivered at the Annual Combined PulseNet Update and National Foodborne Epidemiologists Meeting, on April 3, 2006, in Miami, Florida.

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

Introduction
(SLIDE 1)
Thank you. I appreciate this chance to speak with you about USDA's efforts to combat Salmonella and lay the foundation for a more robust risk-based inspection system.

It's also a real pleasure to be here to help celebrate the 10th anniversary of PulseNet. Anniversaries like this offer us an important opportunity to learn from past challenges, celebrate current achievements and plan for future success.

(SLIDE 2)
Some of you might already know this, but USDA is also celebrating an important milestone. 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.

However, 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 nose cannot smell and that our fingers cannot touch.

Your future work, insight and effort will be critical to ensuring that our food safety system will be able to meet these demands in the next century. I also know that your work is helping to save lives every day. You can never know just how many lives you save every day, but that's what's unique about the public health field. You might have saved a thousand, but just one is an accomplishment.

There are two things that we can be sure about PulseNet. The first is that FSIS' food safety activities are built upon the strong foundation provided by your microbiological and epidemiological investigations.

The second is that I don't want to imagine what my job would be like without the support that PulseNet provides to USDA. PulseNet is critical in helping us determine if an outbreak is occurring especially when cases are geographically dispersed across the country.

But before I go any further, I'd also like to recognize the important contributions that local and state epidemiologists and their health departments make every day to food safety and public health.

[Click to the next slide as Dr. Raymond mentions each leg of the stool]
(SLIDE 3)
(SLIDE 4) Federal Government
(SLIDE 5) State Government
(SLIDE 6) Local Government
(SLIDE 7) Broken stool

Coming from state government, I realize and truly value the important role states and local governments play, and I'll do whatever it takes to improve local, state and federal cooperation for the well-being of the American public.

That importance was once again highlighted in a recent recall of adulterated product. I'm sure those from the Minnesota Department of Health already know what I'm talking about.

Thanks to an intense collaborative public health investigation between the Minnesota Department of Health, the Minnesota Department of Agriculture and FSIS, we were able to link exposure to a specific raw poultry product to human illness.

That investigation helped FSIS make the determination that the raw chicken entrees' frozen state, labeling and cooked appearance could cause consumers to believe these raw products were pre-cooked. If that happened, then consumers might not follow the cooking instructions and that would mean they would be at additional risk for illness. And that's exactly what did happen.

We used all the tools at our disposal including epidemiological, microbiological and traceback evidence, as well as patient histories, to make the link between exposure to that particular product and the illnesses that the Minnesota Health Department was seeing.

In fact, this investigation led FSIS to recall 75,800 pounds of frozen stuffed chicken entrees because they were adulterated and could have been unhealthful or unfit for human consumption. This kind of cooperation between the state and federal government is absolutely critical to ensuring the safety of our food supply.

This quick response, which I believe helped to prevent further illnesses, was made possible by the efforts of the Minnesota Health Department. But I want you to know that I'm well aware that the dedication and professionalism they demonstrated isn't unique to Minnesota.

Recent Successes
(SLIDE 8)
I mentioned earlier that anniversaries give us a great opportunity to celebrate our current achievements. I am proud to say that we have a number of food safety successes to talk about. Thanks to your dedication, we've 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 9)
(SLIDE 10)
(SLIDE 11)
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 12)
Compared to the 1996-98 baseline, illnesses caused by E. coli O157:H7 decreased by 42 percent. I'm 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.

(SLIDE 13)
(SLIDE 14)
(SLIDE 15)
Taken together, these human health results and decreasing numbers of pathogens in our sampling program indicate that our risk-based approach is working. All of this is good news, but we still have areas of concern.

Salmonella
(SLIDE 16)
According to our sampling data, the number of product samples positive for Salmonella has been on the rise in several poultry categories over the past few years, specifically in young chicken (or broiler) carcasses.

The four-year trend of rising rates in broiler carcasses does not bode well for public health. The rates have risen nearly 50 percent in just three years, and you do not have to be a foodborne epidemiologist to know that this isn't a positive development.

The CDC's most recent FoodNet report is not much better. It's 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's a tremendous burden on human health.

(SLIDE 17)
While CDC did report that Salmonella infections dropped eight percent, only one of the five most common strains, which accounted 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's imperative that we take a risk-based approach to investigating and controlling the incidence of Salmonella in meat, poultry and egg products. This is an approach that will be strengthened by your microbiological and epidemiological investigations.

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 18)
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 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 the pathogen's prevalence.

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 the workforce 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 that can causes human illness, does so with varying severity. In fact, the most common serotype 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 19)
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 establishments (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 20)
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 two percent after an FSIS food safety assessment. Our goal as we move forward must be to make these reductions a reality across the board.

FSIS 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 cause 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.

We recently announced an initiative to reduce Salmonella in meat and poultry products. It incorporated 11 steps, including increased sampling in plants where it's 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'm not going to get into the specifics of our 11 step plan today. That information, as well as numerous presentations on how to further reduce the prevalence of Salmonella F — pre-and post-harvest; — can be found on FSIS' Web site at www.fsis.usda.gov.

However, I'm confident that this initiative will help FSIS to be proactive and take action before people get sick.

Robust Risk-Based Inspection System
(SLIDE 21)
FSIS must develop these critical abilities further and that's 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 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. An enhanced risk-based inspection system offers this ability.

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.

Transparency
I assure you that we will use a transparent and inclusive process to seek input from all of our food safety stakeholders 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.

FERN
(SLIDE 22)
As we move forward in our fight against Salmonella, and toward a more robust risk-based inspection system I want you to know that we are also dedicated to improving our food defense capabilities.

A focal point to our strategy is the enhancement of the Food Emergency Response Network (FERN), which is a joint laboratory partnership between FSIS, the Department of Health and Human Service's Food and Drug Administration (FDA), and selected state public health laboratories.

We saw what happened to lab capacity and U.S. Postal Service efficiency when just a few letters were sent containing Anthrax to just a few persons. The same can happen again with one phone call to the Post indicating that the meat supply is contaminated intentionally.

This is why we are working hard to provide 23 selected existing state or local laboratories with the necessary training, equipment and supplies they need so that surge capacity can be handled more quickly and closer to home.

From a public health standpoint, an investment in FERN is absolutely essential if we want to prevent, or mitigate, the loss of life and economic hardship that could result from a hoax, or an intentional or unintentional incident that affected the food supply. We must also be prepared for the distinct possibility that one or all of our three FSIS laboratories could be incapacitated in an attack on our food supply.

Closing
Before I close, I want to remind you that we already 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.

Since taking this job I have encountered a lot of people who have told me that further dramatic improvements in food safety is just not possible. I don't believe that for a moment and let me tell you why.

I believe it is possible because I know the history of public health. After all, public health's entire history is really just a long list of achievements that were at one time thought impossible. It is the work of dedicated scientists like you that ensures that the impossible will eventually become commonplace given enough time.

(SLIDE 23)
Did you know that 100 years ago, one in five coffins contained a child under five years old? Today that number is only one 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 have been critical — 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 24)
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 everything that you do to ensure the safety of the U.S. food supply.