Remarks prepared for delivery by Deputy Under Secretary for Food Safety Dr. Merle Pierson, at the International Association for Food Protection's 91st Annual Meeting, August 10, 2004, Phoenix, Arizona.

Introduction

Good afternoon. It's truly a pleasure to speak to you at IAFP's 91st Annual Meeting. IAFP has been serving food safety professionals nearly as long as the length of time the Meat and Poultry Inspection Acts and the Food, Drug and Cosmetic Act have been around. This nearly century-long service has been invaluable to academia, industry and government. Above all, it has been invaluable for its contributions to the protection of consumers worldwide, and we look forward to working together with you as we move forward in the 21st century.

The organizers of this meeting have again arranged an excellent program. It is always rewarding to come to this meeting and discuss food safety issues with colleagues who have been working in food safety for many years as well as meeting individuals who are bringing new perspectives.

Advancing food safety is an immense challenge that is only accomplished through the joint efforts of all stakeholders. For example, assuring the safety of meat, poultry and egg products, the area in USDA where I share responsibility, represents nearly 6,500 establishments that must provide safe products for domestic and international consumers. In addition, we have regulatory responsibility for all such products imported into the United States. Although regulation is an important part of the food safety system, it takes cooperation from government, producers, processors, educators and scientists, consumers and many others to effectively protect public health. Your role in providing the science and new technologies is critical to our success. There are many examples of how you have provided new insights into the identification, ecology, growth characteristics, methods of control, and other factors that have been essential to technologies and policies for protecting public health.

I would like to present to you today an overview of the USDA/FSIS role, strategy and outcomes in protecting the safety of products under our regulatory jurisdiction. Time does not permit discussion of all aspects of this responsibility, thus discussion of such areas as inspection force training, consumer outreach activities, management, and homeland security while critical are not included. Further discussion of these areas can be found in our "Vision" papers that I will mention in a few moments.

A Vision for the Future

Last year at your annual meeting in New Orleans, Dr. Murano shared with you a vision to improve food safety that outlined science-based initiatives USDA's Food Safety and Inspection Service (FSIS) would implement to improve public health. This vision, and the strategies to achieve it, were described in a document titled Enhancing Public Health: Strategies for the Future.

Last month, we released a follow-up document titled Fulfilling the Vision: Initiatives in Protecting Public Health, as you see on this slide. If you have not had a chance to read it - stop by the FSIS booth in the exhibit hall after this session and pick up a copy. Or you can visit our Web site at www.fsis.usda.gov to read an electronic version.

As you know, the crux of our challenge centers on combating biological, chemical and physical hazards that range from the easily understood to those that present new and complex challenges. Thus, we must not only rely on existing knowledge and strategies for food safety, but also introduce new approaches.

As part of FSIS' continuing process to meet these food safety challenges, we prepared, Fulfilling the Vision, a plan to use the latest in science, as well as to most effectively use our resources and authorities to further improve our food protection systems.

These vision documents show how committed the Bush Administration is to food safety and achieving results from science-based initiatives.

For me, as a food scientist, it has been exciting to work in Washington with this strong backing to ensure that our food safety policies are absolutely effective not only for the American consumer, but for consumers worldwide. For the rest of my discussion, I will share with you the results we have achieved through the use of science, risk assessments, and close collaboration with our partners. These factors were all vital in the initiatives laid out in our first vision document. Then, I'll cover a series of new measures described in Fulfilling the Vision, which we are currently focusing on to further improve the U.S. meat, poultry, and egg products supply.

Evaluating the Effectiveness of the 2003 Vision

While there may be many approaches to measuring success, we looked at a number of indicators related to public health outcomes and pathogen reduction. Such an evaluation is essential to determining the success of our strategies and developing new ways to combat threats to public health. As you know, in our high-speed, fast-food world, it is difficult for some to understand that successful science is not immediate gratification and it is not easily measured. But over time, positive results show that our approach is working.

An effective gauge of how our policies and industry practices are working is looking at how public health is impacted. In April of this year, the Centers for Disease Control and Prevention (CDC) reported significant declines from 1996 to 2003 in illnesses caused by E. coli O157:H7, Salmonella, Campylobacter and Yersinia.

Specifically to the products USDA regulates, illnesses caused by Salmonella Typhimurium, typically associated with meat and poultry, decreased by 38%. Between 2002 and 2003, illnesses caused by E. coli O157:H7, often associated with ground beef, dropped by 36%.

The CDC attributes the changes in the incidence of these infections in part to the control measures implemented by government and industry and enhanced food-safety education efforts. I also want to add that it is important to point out that these results were only achieved through your advances in science and technology. We are hopeful that these reductions in foodborne illness will continue.

E. coli O157:H7 E. coli O157:H7 provides an important example of the results that have been achieved. I already mentioned the CDC outbreak data. In addition, we are seeing a significant drop in the percentage of E. coli O157:H7 positive regulatory samples in ground beef. In 2003 there was a 60% reduction in the number of positive results compared to 2002.

There have been many changes and new approaches taken over the past couple of years taken by industry and FSIS to more effectively reduce the prevalence of E. coli O157:H7 in ground beef. Beginning in October 2002, FSIS required all beef establishments to reassess their HACCP plans relative to the potential presence and control of E. coli O157:H7 in raw beef. Then FSIS personnel conducted the first-ever comprehensive audits of HACCP plans in nearly 1,800 beef establishments. Sixty two percent of those plants made major improvements based on their reassessments, and 60% added O157:H7 as a pathogen likely to occur. I believe this sequence of events initiated by FSIS, will continue to contribute to the kind of dramatic results we have been seeing.

We can look at the findings from our microbiological testing program for E. coli O157:H7 in another way.

• In 2001, our testing program yielded 59 positive results out of 7010 samples;
• In 2002, there were 55 positive results from 7025 samples;
• In 2003, there were 20 positives out of 6584 samples; and
• So far this year, there have been only eight out of 4279 samples!

This certainly is a credible testament to the value of cooperation and application of science, technology and better process control in preventing contamination of ground beef by this very difficult and challenging pathogen.

Our most recent initiative in further reducing E. coli O157:H7 has been a series of directives issued in May 2004 that provided risk-based guidance to inspection personnel. For example, establishments that have designed and implemented sampling and verification testing and have a high degree of confidence of finding the pathogen in both trim and finished ground product will be sampled less frequently by FSIS than other establishments not having such programs. In addition, we will weigh our sample scheduling process so that an establishment producing a large volume of raw ground beef products will be sampled more frequently than an establishment with a lower volume of production of raw ground beef products. This type of targeting will deploy our resources more efficiently and effectively. These directives also provide for a number of other actions that are the subject of a series of public meetings that FSIS has been conducting. If you need to know more about these actions I refer you to the FSIS Web site.

Listeria monocytogenes
Next, I will mention initiatives related to Listeria monocytogenes (Lm). Consumption of foods contaminated with this pathogen can result in serious public health consequences to certain susceptible groups of people, and preventing its contamination of ready-to-eat (RTE) meat and poultry products is a high priority for USDA. Currently we have a zero tolerance policy for Lm in RTE products.

CDC data on foodborne illnesses has indicated that the incidence of infection from Lm decreased between 1996 and 2001. However, the level then reached a plateau, so it became evident that additional targeted measures were needed. In addition, we also knew that since the 1990s, there had been a major Listeriosis outbreak in the United States every two to four years.

Clearly breaking the all-too-familiar cycle is critical to lowering the approximate 500 deaths caused by Lm each year. As part of our overall risk assessment process, we looked at a risk ranking of products and estimated the potential level of exposure of three age-based U.S. population groups to Lm in 20 food categories. We then took these data and related them to public health consequences.

Through studies conducted by NFPA as well as ARS and others we were able to obtain essential data on Lm in various RTE products, and thus, better target policies for intervention strategies.

These surveys then served as key information for the development of an FSIS risk assessment on Listeria in RTE meat and poultry products. The risk assessment, in conjunction with a previously released FDA/FSIS risk ranking, public comment gathered on the topic and a peer review of the risk assessment provided important data for designing a final Lm rule.

On June 6, 2003, FSIS issued an interim final rule on control of Lm in RTE meat and poultry products. The rule outlined three strategies that an establishment could choose from to control the pathogen depending on its product(s) and the environment in which it operates. The frequency of FSIS conducted verification activities would then be risk based with most conducted when an establishment relied solely on sanitation practices for Lm control while there would be fewer where an establishment had more aggressive process control measures and interventions.

Late last year, we released data that showed a 25 percent drop in the percentage of positive Lm regulatory samples from the year before, and a 70 percent decline compared with years prior to the implementation of HACCP. We trust that with the measures implemented by industry and FSIS policies this trend will continue.

To determine the impact of the Listeria rule in terms of changes made by establishments, we surveyed our inspection personnel who were located in 1,400 establishments producing RTE meat and poultry products. We found that more than 87% of the plants changed their operations in one way or another to more effectively control Lm. Such changes included implementing Listeria testing, the use of antimicrobial agents, and post-lethality treatments. We will continue to monitor our progress on reducing Lm and make any necessary changes.

Salmonella
We have seen similar reductions in Salmonella. As you are no doubt aware, a couple years ago we issued new procedures for using Salmonella performance standards as a verification tool for food safety. Under these new procedures, instead of waiting for two consecutive failures of tests to trigger an in-depth review of plant's SOP and HACCP plans, reviews are initiated after any series of tests fails to meet a standard.

This process and other science-based initiatives, including those implemented to reduce O157:H7 played a significant role in reducing the prevalence of Salmonella in raw meat and poultry regulatory samples. Salmonella in raw meat and poultry regulatory samples has dropped substantially over the past six years. Out of the number of regulatory samples collected and analyzed by FSIS in 2003, 3.8 percent tested positive for Salmonella, as compared with 4.29 percent in 2002; and 10.65 percent in 1998.

Recalls
Although our regulatory data may not represent the prevalence of these pathogens nationwide, it is certainly indicative of a downward trend. Our pathogen reduction policies are also having a direct impact on the decreasing number of recalls over the past two years. The number of Class I, or high risk, recalls has nearly been cut in half from the total observed in 2002. In the first half of 2004, the number of Class I recalls is 16, down from 29 in the first half of 2003.

Bovine Spongiform Encephalopathy (BSE)
Recalls are just one method to protect public health; however, they are, by far, not our only means. A significant amount of public health protection comes from the behind-the-scenes efforts to improve our systems and infrastructure that go unnoticed every day. The December 23, 2003, recall of beef products following the announcement of the detection of a BSE positive cow from a slaughter operation in Washington state could be seen by many as a precursor to the implementation of our BSE measures.

However, we had completed an extensive amount of groundwork on FSIS' four BSE measures before Secretary Veneman's major policy announcements on December 30. Our swift actions to get the one notice and three interim final rules, as you see on this slide, published in 13 days were unprecedented. The process normally would have taken several months; however, with strategic planning this normally daunting task was achieved very quickly.

The implementation of our BSE rules is a testament to the importance of planning and having structures ready to protect public health in case of a finding such as BSE occurs. Furthermore, these regulations add a significant level of protection to an already, existing strong food safety system.

Initiatives

You can read more progress and strategies for reducing pathogens, as well as our BSE measures in Fulfilling the Vision. While it is wonderful to stand up here and talk about what has been done, the most important part of this document is, in fact, our continuing vision for the future. Again, I stress that to move forward effectively and better protect public health we have to do so as a cooperative effort that is based on science.

I want to briefly outline four of these initiatives with you today.

Enhanced Data Integration
Our first initiative is really more of a challenge that we have given ourselves. This is to anticipate and predict food safety risks through enhanced data integration in order to protect public health. One significant way to accomplish this is through the analysis of FSIS regulatory sampling data as well as other sources of data in order to detect trends and identify connections between persistence, prevalence and other factors such as practices employed by plants, seasonal variations, and establishment size.

However, there is a missing link here. FSIS would need access to industry data. Including data collected by the establishment would add robustness to FSIS' information and improve the quality and validity of decisions that are made. Ensuring the availability of data to FSIS from industry, academia, States, consumers and others will be necessary to move forward. One way to accomplish this may be through the establishment of a third-party repository to provide data integrity and confidentiality. Obviously, we are very early in this initiative, and I encourage you to stay tuned to this issue as more details become available in the near future.

Apply Risk into Regulatory and Enforcement Activities
The next initiative is for improved application of risk into regulatory and enforcement activities. We are beginning to field-test the Hazard Control Coefficient, or HCC, which is a measurement of the effectiveness of pathogen controls used by individual establishments.

The HCC establishes the level of plant compliance through an analysis of in-plant and Agency verification testing, as well as inspection data. The HCC will help us better understand the frequency and types of food safety failures so that more appropriate responses, based on risk rather then a one size fits all mentality can be designed and implemented.

Associate Program Outcomes to Public Health Surveillance Data
Our third initiative is to improve the association of program outcomes to public health surveillance data. We are working closely with the CDC and the Food and Drug Administration on developing and analyzing public health trends. Data that link foodborne illness outbreaks with specific foods need to be connected with prevalence data of specific pathogens in specific foods.

The Foodborne Diseases Active Surveillance Network, or FoodNet, allows our partners and us to integrate this data by determining the burden of foodborne disease, monitoring foodborne disease trends and determining the extent of foodborne diseases attributable to specific foods.

Improving Food Safety Beyond our Borders
The final initiative I will mention is our continued dedication to improving food safety beyond our borders. Our goal is to work with our partners in the western hemisphere to develop common food safety standards and harmonize food safety education, information and communication throughout the region.

To achieve this, last week, we announced the establishment of a Food Safety Institute of the Americas. This institute will be a cooperative educational and research organization designed to promote food safety and identify and develop educational programs throughout the Americas.

Conclusion

The implementation and maintenance of the strategies found in the vision paper have led to significant measurable advances in FSIS' mission to protect public health. These initiatives will provide an essential and important foundation for the future.

Not only is it critical for us to continue to refine and enhance these advances based on our current regulatory authority and available scientific knowledge, it is essential that we continue to modernize our inspection system through risk-based approaches and further refine our management agenda in order to have the flexibility to meet ever changing threats to public health. Furthermore, we will 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.

I look forward to continue working with IAFP and its membership to fulfill the initiatives laid out in our vision paper. As I mentioned, you can pick up one here at our booth, or read a copy that is posted on FSIS' Web site at www.fsis.usda.gov.

We welcome the input of all interested parties and encourage the free exchange of ideas to further enhance the safety of the U.S. meat, poultry and egg products supply. Thank you.