Remarks prepared for delivery by Dr. Richard Raymond, USDA Under Secretary for Food Safety, to the Public Health Preparedness Conference, February 23, 2007, Washington, DC.

Note: Slides are available in an attached PowerPoint file (953kb).

Introduction
(Slide 1)
Good morning. It's great to be here. I appreciate this opportunity to talk with fellow public health professionals about the important work that USDA is doing to ensure the safety of the U.S. food supply and improve the public's health.

I know that food safety involves numerous complex issues that can be difficult to wade through. When I was back in Nebraska and received a call letting me know I was being considered for a presidential nomination for this position, I'm not afraid to admit that my very next step after hanging up the phone was to log on to the Internet to do some research. I just didn't picture the USDA as a public health entity, or at least having a mission area rooted in public health. And at the time, I was very content with my role in public health in the state and national arena.

But that all changed after I used one of the most important skills a public health official can have; One that is often overlooked by many. That skill of course, is the ability to quickly become an expert on new and emerging issues. This is vital when combined with the ability to make appropriate policy decisions based on less than complete data and the willingness to adjust those decisions as more information filters in. And when you're talking about public health preparedness, these skills are especially critical.

The communities that rely on you to ensure their health and safety do not care if the most pressing threat "wasn't covered back in public health 101." They just want someone who can gather and digest enough accurate, helpful information as quickly as possible. Someone that can make the right decision before all the studies are complete, in order to protect them and their families.

That is why I'm so glad to see so many of you here today. My goal is to not give you some mindless, unusable info dump. I want to shine a light on an area of public health that doesn't always get enough attention so you can see where you might need to get a bit more information so you can be prepared.

I want to walk you through who is in charge of what and why. Then, I thought it would not hurt to give you some reasons why you really should not be worried about eating lunch today. Finally, I want to explain to you some of the recent initiatives and issues we're dealing with that might actually affect you and your work back at home.

Now, as the Under Secretary for Food Safety, I oversee the Food Safety and Inspection Service, which carries out USDA's food safety regulatory program, as well as important public health outreach and education activities focused on enhancing the safety of the U.S. food supply. It's the 'AND' in FSIS that I wasn't aware of before taking this job. I can tell you though that we do much more than just inspect and regulate. Our mission is to ensure the safety and wholesomeness of the nation's commercial supply of meat, poultry and egg products. It doesn't matter if those products are imported to, or exported from, the United States.

We are also dedicated to fostering safer food handling habits among all types of food handlers, and developing science-based policies to improve our food safety and defense systems. FSIS has more than 9,400 employees, approximately 7,600 of whom are inspection and veterinary personnel present daily in nearly 6,000 meat, poultry and egg product slaughter and processing plants throughout the United States.

The products they inspect represent more than one-third of all consumer spending on food in the United States and about 40 percent of all domestic food production. USDA has been involved in food safety issues for a long time. In fact, last year we celebrated the 100th anniversary of the passage of the Federal Meat Inspection Act (FMIA). It ushered in a new era of food safety on a national level. The achievements we celebrated were made possible thanks to the help and cooperation of you and all of our food safety partners.

The Act was a watershed event in the history of food safety and public health in the United States. It called for animal carcasses to be inspected before they entered the food supply via daily continuous inspection in every meat slaughter and processing establishment.

Since that time, the agency has progressed from a simple command and control regulatory agency that recalls food and closes plants into a public health agency that prides itself on preventing illnesses. This is in part accomplished through our intense efforts to foster partnerships amongst government, industry and consumers.

Acts and Authorizing Statutes
(Slide 2)
Our vital food safety activities are conducted under a number of federal acts and authorizing statutes. The three most important are the Federal Meat Inspection Act of 1906, which I just mentioned, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970. They provide the basis for FSIS' ability to perform as a public health agency.

I'm not going to go into the details of these acts. That's something that can be found on our Web site at www.fsis.usda.gov. But I do want to point out that each statute requires that meat or poultry products must be wholesome, unadulterated, and properly marked, labeled and packaged. In addition, one of the requirements is that we have a daily inspection presence for processing, as well as a carcass by carcass inspection. Nearly all of FSIS' activities focus around one or more of these vital mandates and means that we inspect all meat, poultry and egg products produced in the United States.

FSIS' sister agency, the Department of Health and Human Services' Food and Drug Administration, is responsible for all other food products not under the jurisdiction of FSIS. This can include fresh produce, ice cream, and even seafood. I believe that this system works well and that the nation's public health is well protected. The combined efforts and expertise of the different federal and state agencies allow quicker resolution to outbreaks and crises than any one of the agencies could accomplish working by itself.

However, that doesn't mean that from time to time odd regulatory inconsistencies and jurisdictional issues don't occasionally arise — such as which agency regulates a bagel dog or a closed face sandwich (FDA) versus an open faced sandwich (USDA). When this happens, both of our agencies work cooperatively with our food safety partners in order to resolve the issue in a way that better protects the safety of the food supply.

Just in case a few of you are still a little unsure of the jurisdiction of products inspected by both agencies, I want to walk you through making a frozen pizza. The basics I know are easy, but sometimes processed food can be tricky.

(Slide 3)
First you have the dough, which is under FDA's jurisdiction.

(Click for sauce)
Then you add the tomato sauce. Now, unless for some odd reason you are using a Bolognese sauce this too is going to be under the FDA.

(Click for Cheese)
After the sauce comes the cheese. Right now, this simple cheese pizza will not see an FSIS inspector.

(Click for Shrimp)
Now let's say this is some crazy California pizza and you add shrimp as a topping. It does not change a thing and it is still a FDA-inspected product.

(Click for Pepperoni)
But really, how can you call a pizza a pizza if it doesn't have any pepperoni on it? Now things get interesting, and this pizza now needs to be inspected by FSIS instead of the FDA. Even though FSIS was there at slaughter, and again in the pepperoni processing plants.

(Click for Onions)
Let's say you add onions. Those fall under FDA. It doesn't change the fact that the product falls under FSIS' jurisdiction.

(Click three times to place the sausage, mushrooms and bacon)
Now you throw in some sausage, mushrooms and bacon and not only do you have a heart attack on a plate, but you still have a frozen pizza that needs to be inspected by FSIS before it can be sold.

I mentioned earlier that sometimes there are a few inconsistencies or regulatory confusion when it comes to which agency needs to inspect what product. The bureaucratic term for the issue is Amenability, and please understand that only a miniscule percent of the products FSIS and FDA regulate are affected.

However, that is no reason to create confusion, especially when the health and safety of the public are at stake. That's why both agencies are working together to clarify what items are under the jurisdiction of which agency with a transparent, consistent and, most importantly, common sense based approach.

On December 15, 2005, FSIS and FDA held a joint public meeting to receive comments. Based in part on this input, we are now in the final stages of writing a proposed rule on this topic.

Food Safety Successes
Thanks to this focus on cooperation and collaboration on issues that directly relate to public health and food safety from all of our food safety partners, we've seen dramatic improvements in the safety of meat, poultry and egg products. The best indicators of this progress are those that directly relate to pathogen reduction and public health outcomes.

(Slide 4)
Since 1998, the percentage of regulatory samples of meat and poultry products that tested positive for Listeria monocytogenes has fallen by almost 60 percent. In 2006, .61 percent of random product samples were positive for this dangerous pathogen, but only 0.47 percent of risk-based samples. This is even more remarkable than meets the eyes, as FSIS has recently focused its efforts on the products that present the greatest public health risk.

(Slide 5)
The results are just as dramatic for raw ground beef sampling for E. coli O157:H7 in ground beef. Since 2000, positive samples have declined by 80 percent. Only 0.17 percent of FSIS' samples were positive in FY 2006, sustaining the numbers we saw in 2004 and 2005. This is down from the 0.86 percent in 2000. According to the numbers released two weeks ago, only 20 samples of the more than 11,000 raw ground beef samples taken in 2006 tested positive for E. coli O157:H7.

(Slide 6)
We're also seeing dramatic declines in the rate of human illness from pathogens commonly associated with foodborne illness. Using the Centers for Disease Control and Prevention's (CDC) most recent statistics and comparing human foodborne illness data from 2005 with 1998 data, E. coli O157:H7 human foodborne illness rates are down 29 percent,

(Slide 7)
and illnesses from Listeria monocytogenes are down 32 percent. It's important to pause for a moment here, and make certain everyone clearly understands that reductions in positive product sampling seem to correlate with decreases in human illnesses.

(Slide 8)
The news on Salmonella hasn't been as encouraging, but this appears to be changing for the better. After declaring war on Salmonella in August 2005, and announcing our 11-point Salmonella reduction plan in February of 2006, we've seen consistent declines in product positive rates.

(Slide 9)
For example, in broilers we've seen the numbers go from over 16.0 percent of samples testing positive for the pathogen in 2005 down to almost 11 percent for the last half of 2006, a period when testing was targeted to the establishments with the worst track records for controlling Salmonella. These numbers are a direct reflection of FSIS' science-based policies implemented in the past two years, and our partners' efforts to produce a safer product.

It is my hope that over time we will see dramatic declines in the rates of Salmonella infection from meat and poultry products like those we've seen in E. coli O157:H7 and Listeria monocytogenes in the past seven years in concert with declining positive regulatory product testing results.

(Slide 10)
I also hope everyone is starting to see how closely USDA, and our sister agencies cooperate on multi-jurisdictional food safety issues, whether those agencies are State, local or Federal entities, in order to protect the food supply.

I may be speaking to the choir here, but to be certain we are all on the same page, I want to talk about two of the feds most important collaborations — FoodNet and PulseNet. FoodNet (the Foodborne Diseases Active Surveillance Network), is part of CDC's Emerging Infections Program. FSIS worked in conjunction with CDC, the Food and Drug Administration (FDA), and epidemiologists and public health laboratories in several states to establish FoodNet in 1996.

FoodNet conducts active surveillance of foodborne diseases, case-control studies to identify risk factors for acquiring foodborne illness, and surveys to assess medical and laboratory practices related to foodborne illness diagnosis. It also provides estimates of foodborne illness and sources of specific diseases that are usually found in the United States and interprets these trends over time. Data are then used to help analyze the effectiveness of the Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) rule and other regulatory actions, as well as to develop public education initiatives.

It is important to know that this data is not 100 percent indicative of the full picture of foodborne illnesses in the United States. FoodNet is not running in every state and so an illness or outbreak may not be accounted for in the numbers. In fact, it is only operating in 10 states or regions. An outbreak in Nebraska will not affect data; but an outbreak in Miami will. Even so, this information has proven vital to our ongoing efforts to implement science-based initiatives to reduce the rate of human illness from pathogens commonly associated with foodborne illness.

A sister system is PulseNet, a collaborative national computer network of public health laboratories, also established in 1996 that helps to rapidly identify outbreaks of foodborne illness. Laboratories now perform DNA "fingerprinting" on bacteria taken from positive product samples and human illnesses. The network permits rapid comparison of the "fingerprint" patterns through a CDC database.

PulseNet is an early warning system that links seemingly sporadic illnesses together and enables public health officials to more quickly identify and respond to multi-State illness outbreaks. In fact, through the use of PulseNet, we're able to identify seemingly disparate foodborne illnesses as actual outbreaks that might not have been recognized as such 12 years ago, and therefore no national publicity. Meaning more people would have gotten sick.

These two systems allow agencies to collaborate and bring their specialized knowledge together to better protect public health. They also allow connections to suspect product to be proven faster.

A good example is in FSIS' collaboration with our Federal and State public health partners during the September 2006 multi-State spinach outbreak — something that I'm sure is still fresh in many of your minds. While spinach is regulated by the FDA, the initial outbreak was reported to FSIS by the Wisconsin Department of Health about a possible link between clusters of illnesses to meat consumed at a restaurant in Wisconsin.

I want to briefly go into the timeline of this investigation to demonstrate just how quickly FSIS and its sister agencies responded. On September 8, 2006 the CDC was notified of a cluster of E. coli O157:H7 infections in Wisconsin. Shortly thereafter, public health officials in Oregon, which is not at all in close geographic proximity to Wisconsin, reported a similar disease cluster.

On September 12, only four days after being notified, PulseNet was able to confirm that the E. coli O157:H7 strains from infected patients in Wisconsin had matching pulsed-field gel electrophoresis (PFGE) patterns and identified the same pattern in patient isolates from other states in the database.

The next day, on September 13, Wisconsin and Oregon notified the CDC that their investigations suggested that the diseases were related to spinach. On that very same day, New Mexico epidemiologists contacted Wisconsin and Oregon epidemiologists about a cluster of E. coli O157:H7 infections in New Mexico associated with fresh spinach consumption. That same day, thanks to their work the CDC was able to notify FDA that an ongoing multi-state foodborne illness outbreak, of E. coli O157:H7 was taking place. Additionally, they could inform the FDA that the outbreak was possibly associated with the consumption of fresh spinach.

I want to stop right here and thank the public health officials from those states and across the country who worked so quickly to identify this dangerous product. I'm convinced that your work saved lives.

Back in Nebraska, I was often under the impression that the Federal government thought little about our work or sacrifices. I just want you all to know that it is my personal experience that this is just not the case. Your dedication allowed the FDA to send out an alert, on September 14 that notified consumers within the United States, Canada and Mexico not to eat bagged fresh spinach.

On September 15, a California company that bags spinach under several brand names announced a voluntary recall of all fresh spinach-containing products. The next day FDA expanded its warning and advised consumers to not eat fresh spinach or fresh spinach-containing products. Finally on September 18, working with the International Food Safety Authorities Network, Taiwan and China were also notified about the outbreaks. This allowed our trading partners to deal with the exported product that was no longer in the United States.

This wide ranging response was carried out in only 10 days. Although the active FSIS investigation ended on September 21, the agency continued to closely cooperate with the FDA, CDC and your agencies in their investigation, and stood ready to respond if needed.

Throughout this endeavor, the agency remained vigilant in assisting our local, State and Federal partners in assuring public health priorities were met. The combined efforts and expertise of the federal agencies along side your state agencies allowed quicker resolution to this outbreak than any one of the agencies could have accomplished working by itself.

However, we can't be satisfied with these partnerships or the numbers I mentioned earlier. They don't mean much if you're the one who gets sick — for you, it's still 100 percent. We must continue to improve our public health protections and prepare for future threats using sound science, before those threats can harm consumers.

Risk-Based Systems
(Slide 11) It's why FSIS is working in cooperation with its food safety partners to create a more robust risk-based inspection system for its meat and poultry processing facilities. We just announced the timeline and more details on this system yesterday.

Our goal is to focus more of FSIS' time and valuable resources on prevention, rather than on response. What we're after is a common sense public health strategy that best serves the American consumer by preventing human illness. We will base inspection time on inherent product risk and individual plants' abilities to control risk. Their track record so to speak.

I want to emphasize that a more robust risk-based inspection system for meat and poultry processing is not about saving money or decreasing FSIS' inspection force. Instead, it's about spending our work hours in a smarter way with more time in the plants that need our assistance and expertise to better protect the public's health. Ultimately, that's what this initiative is all about — lowering the chance that a consumer — or you — will contract a foodborne illness by reducing the prevalence of dangerous pathogens in the meat and poultry supply.

Under an enhanced risk-based inspection system in processing, we're still going to go to each processing plant everyday. But within that time, some plants will get a closer and more intensive look than others. Ensuring the safety of meat and poultry products given the realities of today's modern supply chain requires that we have the ability to anticipate and more quickly respond to food safety challenges before they negatively affect public health. A more robust risk-based system offers us this ability. This is the most significant change in FSIS inspection in the last decade.

Food Defense
Sadly, in this day and age, the Office of Food Safety must also constantly be looking for ways to protect the U.S. meat and poultry supply from not only unintentional contamination, but also from acts of intentional contamination.

When I was in Nebraska, I always said that a dollar spent on bioterrorism preparedness was also a dollar spent strengthening public health protections. While not exactly the same, the underlying principle can be applied to food defense.

I can tell you right now that a food supply that is better protected from intentional acts of contamination is also better protected from the threat of foodborne illnesses and unintentional acts, like human error or acts of Mother Nature. Risk assessments are the fundamental backbone to the Office of Food Safety's preparedness efforts. The information we've learned from them has helped us assist the industry in developing voluntary comprehensive food defense plans for every establishment.

We have also developed voluntary guidelines for the transportation and distribution sector. They're intended to help facilities and shippers that process or transport meat, poultry and egg products identify potential vulnerabilities in their own operations and address them. It doesn't matter how safe a facility is if the product can be tampered with while en route to the grocery store or restaurant.

In cooperation with the Food and Drug Administration and other food safety agencies, we are also working to enhance our integrated laboratory system, known as the Food Emergency Response Network (FERN).

We saw what happened to lab capacity and U.S. Postal Service efficiency when just a few letters containing Anthrax were sent through the mail. The same thing can happen again with one phone call to Fox News indicating that the meat supply has been intentionally contaminated. 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 in the event of an intentional or unintentional incident affecting the food supply, or a hoax.

Everyone here understands that an emergency response plan is worthless if you don't know how, and when, to implement it during crises. That's why we have begun holding a series of food defense training exercises in each of our 15 district offices. They are designed to practice the reporting of a non-routine incident while coordinating with all levels of government, non-governmental agencies and the private sector within an incident command system structure. Participants include: FSIS, HHS, FDA, FBI, State Health Departments, local health departments, State Agriculture Departments, and industry. Preparation now will ensure that lives are saved in the future.

Retail Consignee Proposed Rule
(Slide 12)
We're not just stopping at improving our food defense or risk-based inspection policies. We've also been looking at the recall process to see how we can better protect the public with new approaches made possible by a careful examination of the food safety environment in which we all operate. It is critical that during a recall, product that is believed to be adulterated be quickly and efficiently removed from consumers' refrigerators and pantries as well as from store shelves and freezers.

We have issued a proposed rule that will make retail consignee, for example, grocery stores, information available to the public during a food recall. We held a public meeting in April to discuss the proposed changes and FSIS is currently analyzing the comments we received.

Making retail consignee information available to the public will help to publicize this valuable information that can save lives. I know that you know your communities better then FSIS does. You know how to get that information out quickly and to the people who need it most.

FSIS' recall releases often get back page space, your releases with retail stores identified will be 6 o'clock news, and front page above the fold in the A.M. The elderly and very young, who are far less likely to learn about recalls by visiting FSIS' Web site on a computer, will be better protected. Simply put, this rule will strengthen the efficiency and effectiveness of our current recall procedures by providing consumers additional information that empowers them to protect themselves and their families.

Being in public health we know that during a public health emergency, early, detailed, accurate and consistent information is one of our greatest tools to prevent panic, illnesses and a collapse in consumer confidence. By working closely with our partners at all levels of government, industry and consumers, we can ensure that the public has the information they need to keep themselves and their families safe.

Food Safety Education
Most of the time, the attention and emphasis at the Food Safety and Inspection Service are placed on the last half of the name — Inspection Service. It's understandable. After all, our inspection activities have had a daily effect on nearly every household in America since the 1906 Meat Inspection Act was passed 100 years ago. It's what we do.

But more recently, at FSIS we've been focusing more on the first half of our name — Food Safety — by expanding the reach and impact of our food safety education messages to consumers and at-risk populations. Vital activities, conducted in cooperation with not only other local, state and federal agencies, but also trade, consumer and public health associations, have begun to benefit from a renewed focus.

Reaching At-Risk Audiences
(Slide 13)
We are also seeking new and improved ways to work with the public health community to decrease foodborne illness. Last fall we held a very successful one-of-a-kind conference in Denver on reaching at-risk audiences. The at-risk audiences I'm talking about are defined as pregnant women, older adults, young children and those with weakened immune systems.

Over 600 people attended — primarily public health officials like you, consumers, industry and food safety educators from around the nation and the world. The reason why this conference was unique was that it was the first meeting to focus on the serious gaps and hurdles we face in reaching at-risk populations — namely the ones who are in the hands of front line caregivers.

We need to expand the number of health care providers as food safety ambassadors. Tapping into the medical community is a charge that everyone at the conference was given — one which I want to also give everyone here today. Patients listen to their trusted health care providers with a much more attentive ear than some balding, grey-haired DC face. No matter how charming and handsome that face may be.

You are our front line responders. Some of you are health care providers yourselves and often see patients on a daily basis. You can help us reach an ever growing at-risk population in this country. With that said, you should also know that we're trying to make it easier for you to play a role in this important effort.

The Be Food Safe Campaign
(Slide 14)
An example of this is the "Be Food Safe" Campaign. It's an updated national mass media and grassroots consumer food safety education campaign that will build on the four key food safety messages of: Clean, Separate, Cook and Chill. It was developed by FSIS, and is being supported and promoted by FDA, CDC and other partners in the Partnership for Food Safety Education. The "Be Food Safe" campaign provides new tools that you can use in educational efforts to positively affect consumer behaviors and reduce the risk of foodborne illness. The look and feel of the "Be Food Safe" campaign takes the Clean, Separate, Cook and Chill messages to another level and gives us another means of reaching out to consumers. The campaign materials highlight behaviors — the specific actions people must take to be food safe when preparing food.

As part of the campaign, we will be providing all of our partners a Partner's Toolkit. The Toolkit has everything you will need to generate publicity at the grassroots level and in local media — community newspapers, newsletters, local radio and local TV. And you will have the opportunity to put your organization's name and logo on these materials and public service announcements.

These four basics of safe food preparation and other safe food preparation messages are so important because current science just doesn't allow us to be able to guarantee that every raw meat and poultry product that's produced will be pathogen-free, nor that every cooked meat and poultry product will remain germ-free as it makes its way to a consumer's plate.

This basic limitation is why FSIS remains determined to get consumers the information they need to help them better protect their families. But even as we strengthen our education and outreach efforts, I want to assure you that we will never stop working to enhance the public health protections offered by our nation's food safety regulatory system.

We're dedicated to improving our food safety AND inspection service. This isn't an "either/or" proposition. It is high time we began to remind people the AND in FSIS means we have a bigger role than JUST inspection. We do want to become known as the public health branch of the USDA.

Closing
Before we move on to your questions, I want to assure everyone that we have a strong food safety system in place, and that's due in large part to the work of everyone here today. However, we do need to continue to improve our preparedness and public health protections.

I feel it is best to view this preparation as a marathon without a finish line. That doesn't mean there is not urgency to the work we do because there are still important mile markers that we must meet.

(Slide 15)
The state of public health is constantly evolving and we must evolve with it. We can't afford to let ourselves, our partners or our nation's food safety systems stagnate. The initiatives that we're discussing here today will ensure the evolution of food safety.

Public health is a lot like riding a bicycle. If we're not moving forward, then we're falling down, and in public health there's no such thing as training wheels. That's why it's so critical that we all work together to create the most effective food safety policies possible that will allow us to keep moving forward.

(Slide 16)
We will continue to engage the scientific community, public health experts, Congress and all interested parties in an effort to identify science-based solutions to public health issues to ensure positive public health outcomes. We all know that we can save lives with sensible science-based policies and together we'll do just that.

With that said, I want to get to your important questions.