Remarks prepared for delivery by Under Secretary for Food Safety Dr. Elsa A. Murano, at the National Food Processor's Association's Annual Conference, Washington, DC, May 20, 2004.

Introduction

Good afternoon. It is wonderful to be here at NFPA's annual convention. I know many of you are here from out of town, so I want to welcome you to Washington, D.C. Even though "D.C." currently stands for District of Cicadas, not the District of Columbia, I hope you will have the chance to get out and see some of this city's wonderful sights.

In Washington, people talk about their inspiring view of the Capitol or the monuments, and the sights often inspire them to work harder and better. Actually, I can't see any of the monument or the Capitol from my windows. However, my view is inspiring nonetheless. The view in my office is quite awesome; humbling and challenging all at once. I am referring to a famous portrait of Louis Pasteur hanging on one of the walls, examining an animal spinal cord. One of the things I most admire about Pasteur is that he disagreed with the popular attitude of the day, "science for science's sake;" he felt this philosophy did not properly serve the people of the 19th century. He believed that science should have practical applications that could be used to improve the lives of others and not be some purely academic exercise.

The opportunity to make a difference in people's lives has always inspired me. This year, I had the pleasure of addressing the graduating class at Texas A&M Kingsville, and I must tell you that being back on a university campus brought back great memories. Back in my teaching days, I would spend this time of the year reviewing my research and teaching agenda, reflecting on what had been done in the past year, and outlining the areas that still needed to be addressed, either in my classroom or in the laboratory. Our lives are so busy that it is difficult to take a step back and look at the "big picture." Yet this self examination is vital to ensure that we evolve, not just exist.

I am currently conducting this same review process in my role as Under Secretary for Food Safety. We have made significant progress over the last 3 years, and I have some great news to share.

First, I want to touch briefly on the Bovine Spongiform Encephalopathy (BSE) issue. Since the discovery of the "cow that stole Christmas," BSE has been front and center with us, as it has with everyone who has concerns about public health, food safety, or their livelihoods in this industry. The measures that the Agency has taken to further prevent BSE demonstrate how committed the Bush Administration and the Department of Agriculture are to protecting public health and improving our food safety system through sound, science-based measures.

The four BSE regulations listed on this slide are indeed aggressive. We are quite confident that these measures will further enhance our efforts to prevent BSE from entering the U.S. food supply. We are currently in the process of reviewing all the comments received on the interim final rules. We received about 22,000 comments, so it will take us a bit of time to go over them all. However, go over them we are and I assure you that when the final rules are issued, they will be based on science.

The American public remains confident in the U.S. meat supply - and with good reason. Organizations such as NFPA have taken a key role in tackling the BSE challenge, building on their reputation as leaders in the area of food safety. I want to take a minute to thank all of you for your cooperation and collaboration in those first few days as we recalled the beef connected to the positive BSE finding. The coordination between all parties, including NFPA members, was a key factor in getting the word out.

Working together has been critical in addressing the BSE challenge. This is absolutely what we need to improve public health - greater cooperation, communication, and coordination over the safety and wholesomeness of meat products. Through USDA's actions and industry's commitment to produce safe products, consumer confidence in the safety of our food supply has not wavered.

Significant Food Safety Advancements

The level of confidence remains strong, in part because of the significant advancements that we have made in the past year. One of these has been improvements in implementation and verification of SSOPs and HACCP, leading to a dramatic decline in the number of meat and poultry product recalls during 2003. As we see here on the following slides, the number of Class I recalls has nearly been cut in half from the total of the previous year (2002). This is an indicator that our scientifically-based policies and programs are working - and you (industry) are making a difference to ensure that the American public receives the safest food possible.

Other indicators of our success last year include reductions in the trend of pathogens that we found in meat and poultry regulatory samples. Late last year, we released data that showed a one-year, 25 percent drop in the percentage of positive Listeria monocytogenes regulatory samples from the year before, and a 70 percent decline compared with years prior to the implementation of HACCP. Most significantly, we are cautiously optimistic that this downward trend will continue, due to the regulation issued in 2003 (last June) for establishments producing ready-to-eat products where Listeria monocytogenes is a concern. Let me tell you why.

The backbone of the Listeria rule was a very thorough quantitative risk assessment, which provided a road map to determine the practices that industry should follow in order to exert the greatest control over this pathogen in ready-to-eat meat and poultry products. The risk assessment showed that testing the processing environment was important, in that it would help find the organism in the niches where it may reside, allowing processors to target and eliminate it from the plant environment before it would contaminate product. Most significantly, the risk assessment showed that the measures that would yield the greatest public health protection were those that would inhibit and/or eliminate the organism from product.

It has not quite been a year since this regulation was published, yet its impact has already been significant in terms of the change it has effected on what establishments do to prevent product from harboring this organism. Pay attention now, because what I'm about to tell you is news. We recently conducted a survey of 1,400 establishments producing ready-to-eat meat and poultry products, and found that more than 87% have changed their operations in one way or another to more effectively control Listeria monocytogenes. For example, more than 57% started testing for Listeria in the plant environment (not just product), more than 27% have initiated the use of an antimicrobial agent to inhibit the growth of this organism, and 17% started using post-lethality treatments. Of course, there were many companies that did not have to change anything, because they were already implementing science-based measures like these in their process. So the bottom line is that this rule challenged those in industry that had not begun to implement these scientifically based measures, to do more to prevent contamination with this pathogen.

Our measures to further prevent E. coli O157:H7 contamination of ground beef have also yielded similar decreases in the levels of this pathogen. To date, FSIS' scientifically trained personnel have conducted the first-ever comprehensive audits of fifteen hundred and fifty beef establishments' HACCP plans. Sixty two percent of those plants made major improvements based on these reassessments, and sixty percent added E. coli O157:H 7 as a pathogen likely to occur. As a result, we are seeing a significant drop in the percent of E. coli O157:H7 positive regulatory samples in ground beef. In 2003, of the E. coli O157:H7 samples collected and analyzed, 0.31 percent tested positive, compared to 0.78 percent in 2002 - or a 60% reduction. This is a definite improvement - and although these figures represent regulatory samples, and are not necessarily representative of the prevalence of this pathogen nationwide, they are representative of a trend downward, and a signal that our science-based policies are working.

And for Salmonella, we issued new procedures for detecting this pathogen. Instead of waiting for three cycles of tests, the discovery of a second Salmonella positive now triggers a review of an establishment's HACCP plan. Due to this process and other science-based initiatives, the rate of Salmonella in raw meat and poultry regulatory samples has dropped by 66% over the past six years and by 16% compared with 2002. As we look closer on this graph, we see that out of the number of regulatory samples collected and analyzed by FSIS between January 1 and October 31, 2003, 3.6 percent tested positive for Salmonella, as compared with 4.29 percent in 2002; and 10.65 percent in 1998. Again, these figures represent a downward trend in our regulatory samples.

I'd like to say that although our regulatory data may not represent the prevalence of these pathogens nationwide, it certainly is indicative of a statistically significant downward trend. However, the real proof of whether our policies are working to protect the public is in determining whether they are impacting public health directly. Well, as a public health official, I am just thrilled that just last month, the CDC, in its annual report on the incidence of infections from foodborne pathogens, noted significant declines from 1996 to 2003 in illnesses caused by E. coli O157:H7 (42%), Salmonella (17%), Campylobacter (28%) and Yersinia (49%). Specifically to the products we regulate, illnesses caused by Salmonella Typhimurium (typically associated with meat and poultry) decreased by 38%. Most significantly, between 2002 and 2003, illnesses caused by E. coli O157:H7, typically associated with ground beef, dropped by 36%. That's a one-year reduction! This reduction in E. coli O157:H7 illnesses brings the U.S. very close to achieving the 'Healthy People 2010' goal of 1.0 case per 100,000 people. We are very hopeful that if we all continue to do our part, this reduction will not be just for one year, but will continue from now on until we have achieved the greatest reduction possible in the illnesses caused by this pathogen.

CDC attributes the changes in the incidence of these infections occurred in the context of control measures implemented by government agencies and the food industry, enhanced food-safety education efforts, and increased attention by consumer groups and the media. As you all certainly know, in 1997 FSIS implemented the Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) systems regulations in meat and poultry slaughter and processing plants.

This is very exciting news and promises to make this summer grilling season one of the safest ever. Further, this data validates our scientific approach to improving public health through safer food. These results also demonstrate your commitment to food safety and I commend you for all of your efforts.

Challenges for 2004

However, there is always room for improvement - and this is where we need to identify our outstanding challenges and determine ways to overcome them. Louis Pasteur said "in the realm of science, luck is only granted to those who are prepared." Food safety is too important to be left to guess work or luck; we must be prepared to identify and meet challenges head on.

Challenge Yourself, Challenge Others

This is not a challenge you need to take on singularly. You need to challenge others to take a responsibility for improving food safety and public health. Hold your suppliers accountable for providing the cleanest raw product possible. If you are vertically integrated then examine ways in which you can apply HACCP-oriented principles in husbandry. Reexamine your processing lines and make sure that your critical control points are scientifically verifiable and are being verified day in and day out.

It is critical that every segment of the farm-to-table chain be held accountable for providing the safest product possible to the next segment of the chain. The principles of HACCP are the standard accepted throughout the world…a standard that we know works. HACCP is the most scientifically advanced process for food safety worldwide and it gives us the assurance that potential hazards are controlled and eliminated from the food production cycle.

Holding Ourselves Accountable

• To improve the management and effectiveness of our regulatory programs,
• To ensure that policy decisions are based on science,
• To improve coordination of food safety activities with other public health agencies.
• To enhance public education and
• To protect FSIS regulated products from intentional contamination.

We outlined specific initiatives to make sure we fulfilled those goals, and thereby improved health outcomes for American families. These initiatives were reported in our food safety vision document, Ensuring Public Health: a Vision for the Future. (If you haven't received a copy yet, we have copies here in the back of the room.) As part of our continuing process to evolve, we are currently evaluating where we stand on these items and are preparing to publish a sequel, Fulfilling the Vision. This detailed plan should be available in July and it will drive our policies and actions during the coming year.

This vision is not just words on paper. We are committed to seeing this vision through and our budget request for 2005 reflects this. In addition to budget increases in key program areas that I will mention later, we have requested an additional 9.5 million to further support our efforts to protect the food supply from intentional contamination. Food security has been part of FSIS's mission every day for almost a hundred years and FSIS leads the efforts for USDA on bio-security. These funds will increase our prevention efforts in bio-security with the addition of 37 new positions and funding to test for additional threat agents. 2.5 million has been earmarked for upgrading laboratory facilities and an additional two million to train our inspectors specifically on bio-security issues.

Training has been at the top of our priority list since I joined the Department and it is the first initiative we outlined in the current vision paper. In April 2003, FSIS inaugurated new Food Safety Regulatory Essentials (FSRE) training, which is designed to better equip inspection personnel in verifying an establishment's HACCP food safety system. All trainees received training in the fundamentals of inspection, covering the Rules of Practice, Sanitation Performance Standards, and Sanitation Standard Operating Procedures (SSOP). Customized food safety training is then provided based on the types of products being produced at the establishments where inspectors are assigned. As of the end of last year, more than 1,000 individuals have completed this customized job training regime.

During 2004 FSIS is also training all new entry level slaughter establishment inspectors and veterinary medical officers in technical, regulatory and public health methods. We are also looking at expanding the types of training in the future to meet evolving Agency needs and challenges.

For the 2005 fiscal year we have requested over a 50 percent increase in the FSIS training budget. Four million of the requested 7.1 million would be used to increase the number of entry-level inspectors receiving formal classroom training from 20 percent to 100 percent. Under this proposal, all new inspectors will receive formal training on how to identify and respond to food safety problems. New employees will be required to demonstrate mastery of training in order to be certified to assume inspection duties. An additional $3.1 million has been requested to supplement training for current on and off line field employees to improve enforcement of Hazard Analysis and Critical Control Point/Pathogen Reduction regulations and food safety sampling. These frontline employees are responsible for the making the critical decisions that products are safe; thus it is essential to have a scientifically and technically trained workforce.

As a side note, let me say that I am tremendously fortunate to have someone at the helm at FSIS who is a true believer in the benefits of a well-trained field force. Dr. Barbara Masters brings tremendous credibility, common sense, and above all, integrity to the position of acting Administrator. She and I are in locked-step in our commitment to public health, and believe strongly that science is the way to get us there.

Our second initiative is furthering the use of innovative food safety technologies. I believe that we must encourage the use of safe and effective interventions, and do we all we can to ensure that we facilitate the process.

One way we can do this is by hosting public scientific symposia. Last December in Omaha, Nebraska, we met to discuss the development and use of new food safety technologies to enhance public health. The dialogue and ideas generated at that meeting were also very helpful in exploring how plants can utilize new technologies in their operations.

I know NFPA's members are very active in the development of new technologies, so you are no doubt aware of the establishment of our New Technology Office in August 2003. This group is tasked with expediting the implementation of safe interventions at slaughter and processing establishments. When we completed our risk assessment for Listeria in ready-to-eat products last year, it struck me how important interventions are in mitigating risk.

Our New Technology staff is an experienced team of 12 veteran FSIS employees, people who serve as the single portal for all new technology submissions. We designed this group to better manage the new technology process and allow for implementation as quickly as possible. They are also making sure that all FSIS personnel are aware of new technologies and where they are being used.

To increase the pool of new technology submissions, we have developed a New Technology web page where parties may submit their information on-line. We also have established an e-mail address, FSISTechnology@fsis.usda.gov, for interested groups to learn more about how to have their products or ideas considered. I am happy to report that we have received over 37 proposals for new food safety technologies since we have streamlined the submission process.

We are also working closely with our sister agencies to implement effective, validated technologies. The addition of lactoferrin to our tool box of food protection methods last year is a good example of how this is working. We must not let bureaucratic red tape stymie the introduction of new technologies. Food safety advances can't languish at the bottom of an overfilled "in" box.

Your leadership can help us in this effort. As new technologies are developed, they must be validated. Publication alone is not enough to show safety and success. While FSIS will encourage and support new technologies, you must follow through on your end as well. Correct validation is expected and indeed required, as our Agency will re-verify the results.

Our third initiative is risk assessment coordination. In order to better focus its resources in food safety risk assessment activities, FSIS established a risk assessment coordination team with USDA-wide membership. The need for such a committee is growing as risk assessment becomes more and more important as a means of providing the science behind policy decisions. This group will promote scientifically sound risk assessments and foster research to support risk assessments.

Microbial risk assessment is still in its infancy compared to chemical risk assessments, so the need to share ideas and resources is even more critical. In November 2003, we started this interactive process - of sharing ideas and resources - by holding a public meeting to discuss current government thinking and activities regarding how the three components of the risk analysis framework (risk assessment, risk management, and risk communication) are used to inform and implement risk management decisions.

• FSIS can improve the transparency of the risk analysis process;
• FSIS can balance the need for transparency, stakeholder involvement and peer review with the need for timely scientific guidance; and
• Risk assessments can better inform policy development and decision-making.

We are considering initiating risk assessments on Salmonella in raw beef and poultry, and on the risk of Listeria monocytogenes in packaged deli meat compared to that sliced at the retail level. The latter is an effort that we must pursue, as we continue our efforts to combat this pathogen. This assessment will help us determine whether the risk lies with these products. It may well be that there is still more that can be done at the processing plant, but it may be that the area of focus may expand to what happens after the package is opened and the product is further manipulated during meal preparation.

Our next initiative is developing a solid research agenda. In November, FSIS and the Research, Education and Economics mission area announced a unified research agenda to coordinate USDA food safety research priorities and needs. Research is very important for FSIS to achieve its public health vision. However, FSIS does not conduct research itself, but it does have a role in identifying its own research needs so that the research community can meet those needs. The challenge for the future will be, like Dr. Pasteur strove do to, transfer research results to practical use.

The fifth initiative is to develop a list of best practices for animal production. In consultation with producers, researchers, and other stakeholders, FSIS is developing a list of best management practices for animal production in order to provide guidance in reducing pathogen loads before slaughter.

Last September, we arranged a symposium to discuss ways to significantly reduce the levels of E. coli O157:H7 in live animals before slaughter. We understand that preventing the spread of E. coli and other pathogens on the farm is vital to increasing food safety and protecting public health. The dialogue that was generated from that meeting was very beneficial toward our development of guidelines outlining best management practices at the pre-harvest stage, which we expect to publish this year. Once these guidelines are developed, you can expect to see an aggressive outreach effort by FSIS to distribute these to producers.

Another key initiative is to conduct baseline studies. This is an absolute priority. We are in the final stages of reviewing our protocols, and expect to begin a baseline study to determine the nationwide prevalence and levels of various pathogenic microorganisms in raw meat and poultry. We intend to conduct these studies on a regular basis, if at all possible. The continual nature of the baseline studies will provide both information on national trends as well as a tool to assess performance of initiatives designed to reduce the prevalence of pathogens in meat and poultry products. These baseline studies will also provide important information for conducting risk assessments that can outline steps we can take in reducing foodborne illness.

Moreover, we will be able to correlate prevalence with practices at processing plants, and thereby help us and you to better understand what interventions are working, which ones are not, and if not, why not. In the past, baseline studies have been used to establish performance standards. Well, the new baseline studies will take into account regional variation, seasonality and other critical factors, which were not taken into consideration before, so they will serve to give us the truest picture of prevalence we've ever had.

Achieving the Next Level of the Food Safety

The emergence of previously unrecognized pathogens, as well as new trends in food distribution and consumption, highlights our need for new strategies to reduce the health risks associated with pathogenic microorganisms in meat, poultry and egg products. Through analysis and discussions with stakeholders, we have identified three issues that need to be addressed to attain the next level of public health protection.

The first issue is to anticipate/predict risk through enhanced data integration. To better anticipate risks involving meat and poultry products, we must have the best available data to clearly identify the extent and nature of these risks, so that we may determine an effective response. These data consist of regulatory samples, as well as samples collected by food processing establishments. Thus, there is a need to improve access to and analysis of food safety data from all reliable sources. This is an area where the assistance of groups such as NFPA is extremely important, and I hope I can count on your support.

The second issue is the improved application of risk into regulatory and enforcement activities. Food safety problems need to be documented as they occur, so that conditions may be analyzed, and if need be, corrected. A better understanding of the prevalence and causes of food safety failures could allow better assessment of how to best address them. Data regarding the causes of food safety violations, either within a specific establishment, or within a class, can be utilized in order to better focus prevention and regulatory enforcement strategies.

To develop a relative, real-time measure of how well an establishment controls the biological, chemical, and physical hazards inherent in its operations, FSIS is exploring the development of a Hazards Control Coefficient (HCC). Imagine if we could divide the universe of plants into categories based on the risk inherent in their product (ground beef vs. beef jerky), and on the compliance history of the plant, we could determine which plants have the lowest vs. the highest probability of producing safe product. Such a scheme would help the Agency make resource allocation decisions across this country's more than 6,000 meat and poultry establishments based on risk, and thus maximize food safety and public health protection.

Finally, the third issue is better association of program outcomes to public health surveillance data. We have seen notable advances in preventing foodborne illness, which CDC has attributed in part to the implementation of HACCP. However, there still is a need to determine how specific policies affect public health. In order to accomplish this, data that links foodborne illness outbreaks with specific foods needs to be obtained and documented. It may then be linked with prevalence data of specific pathogens in specific foods. However, to complete the linkage with public health outcomes, a strong connection with human health surveillance data is needed.

Accomplishing this task will help to point regulatory efforts toward focusing its inspection and enforcement on those practices where risk is deemed to be highest, resulting in a more efficient use of government resources. Toward this goal, FSIS is working with CDC's National Center for Infectious Diseases to design and support studies that enable definite connections to be made between occurrence of specific pathogens in specific foods and the occurrence of human foodborne illness.

We are strengthening relationships with state health departments to include attribution data in epidemiological investigations. We are also examining the establishment of a joint task force with CDC to determine ways to improve data collection by Food Net.

We intend to continue to engage the scientific community, public health experts and all interested parties in an effort to identify science-based solutions with public health outcomes. It is our intention to pursue such a course of action in as a transparent and inclusive manner as possible. The resulting strategies should help USDA continue to pursue its goals and achieve its mission of reducing foodborne illness.

Closing

As we all know, protecting public health by ensuring safe and wholesome food is not accomplished through one isolated action or through just one organization. We are all in this together. We need to challenge ourselves, challenge each other, and above all hold ourselves accountable for improving food safety. The health of all Americans relies partially on our continued cooperation and success. All of us have to look at ourselves as public health stewards and never rest in our mission to make the food supply even safer.

At times it may seem overwhelming to overcome the challenges we face. However, Dr. Pasteur faced even greater hurdles and went on to change the face of science, establish the discipline of microbiology, and save lives through the application of his principles regarding how "germs" can be eliminated. I know that by working together, and keeping the big picture of public health in mind, we can succeed.

It has been a pleasure to be here with you today. I thank you for your dedication and efforts, and I look forward to your continued contributions in food safety. Now, I believe we have time for a few questions…