Remarks prepared for delivery by Acting Under Secretary for Food Safety Dr. Merle Pierson, at the 2005 Campylobacter Control Conference, February 23, 2005, Atlanta, GA

Introduction

Good morning everyone. I want to thank the U.S. Poultry and Egg Association for inviting me to speak here today. The importance of this meeting cannot be understated for Campylobacter is a leading cause of gastroenteritis in many countries. Each year, there are an estimated 2.4 million foodborne Campylobacter infections in the United States.

Clearly, it is time to take immediate and aggressive action directed toward significantly reducing the public health risk associated with Campylobacter in poultry. This conference I trust will be a benchmark in attaining this goal. A meeting alone is not enough. I want to challenge you to develop a course of action that the poultry industry can take to effectively reduce the public health risk presented by this microorganism.

What is USDA's approach and role in this challenge? For USDA, the foundation for attaining our goal of protecting public health is establishing policy based on the best available science. For me, as someone who has spent his entire career as a food scientist, I am particularly proud of the work that has been done, in collaboration with our many partners, to develop science-based policies to improve the safety and security of the U.S. food supply.

The Office of Food Safety has used science-based policies to effectively protect the health and well being of millions of consumers worldwide. The crux of our public health challenge centers on combating biological, chemical and physical hazards that range from the easily understood to those that evolve and present new and complex challenges. Thus, we must not only rely on existing knowledge and strategies for food safety, but also continue to introduce and evaluate new approaches.

The regulations we have implemented have had a positive effect in driving down overall E. coli O157:H7, Salmonella, and Listeria monocytogenes prevalence rates. However, in addressing Campylobacter we still have important work ahead of us. First, we need consistent and reliable methodologies to detect Campylobacter in baseline studies. And second, we need to aggressively facilitate the implementation of validated interventions on the farm and during processing. There has been much discussion and research on Campylobacter over the years. It is time to drastically reduce the risk that this microorganism presents to public health. This is why I hope we can really "get the ball rolling" from this conference's discussions.

While there are many approaches to measuring success of pathogen controls, we look at indicators related to public health outcomes and pathogen reduction. Such an evaluation is essential in determining the success of our strategies and developing new ways to combat threats to public health.

In our high-speed, fast-food world, it can be difficult for some to understand that successful science is not immediate gratification and it is often not easily measured. But over time, positive results, or I should say, dramatic declines in foodborne illnesses and incidence of pathogens in products, show that our risk-based approach is working.

E. coli O157:H7 Controls

For example, let's take a look at E. coli O157:H7 in ground beef. After a comprehensive risk assessment on O157:H7 was completed, USDA developed additional strategies to eliminate this pathogen in beef establishments. We required all beef slaughter and processing establishments to reassess their HACCP plans relative to the potential presence and control of E. coli O157:H7 in raw beef. Nearly 2,100 plants reassessed their plans. Then our scientifically trained personnel conducted the first-ever comprehensive reviews of the reassessed HACCP plans. Sixty percent of those plants made major improvements based on their own reassessments. Our policies also resulted in the widespread introduction of validated interventions early in the slaughter process as well as enhanced verification testing throughout the beef industry.

I believe this type of forward thinking will continue to contribute to the dramatic improvements we have been seeing. For instance, let's take a look at results from our microbiological surveillance testing program for E. coli O157:H7 from 2001 through 2004.

• In CY 2001, our testing program yielded 59 positive results out of 7,010 samples - 0.84%;
• In CY 2002, there were 55 positive results from 7,025 samples - 0.78%;
• In CY 2003, there were 20 positives out of 6,584 samples - 0.30%; and
• In CY 2004, there were 14 positives out of 8,009 samples - 0.17%.

Listeria monocytogenes

The effectiveness of planning and applying the best available science in making policy decisions is also evident when we look at Listeria monocytogenes (Lm). Our 2003 interim final rule on control of Lm in ready-to-eat (RTE) meat and poultry products, based on a thorough risk assessment, 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 effect of our Lm policy is encouraging. The latest data from 2003 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.

Last month, we revised our sampling verification procedures so that more product samples are collected when an establishment relies solely on sanitation practices for Lm control, while fewer samples are analyzed in situations where an establishment has more aggressive process control measures and interventions.

Salmonella Controls

Our science-based initiatives, including those used to counter E. coli O157:H7, have played a significant role in also reducing the prevalence of Salmonella in many of the raw products we regulate. If we look at the percentage of regulatory samples positive for Salmonella from our HACCP verification testing program, we see an overall aggregate downward trend from 1998 through 2003. For Salmonella presence in raw meat and poultry 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.

Declining Foodborne Illnesses

This news is encouraging. In addition progress on public health impact is seen in the annual report published by the Centers for Disease Control and Prevention last spring in which they reported significant declines from 1996 to 2003 in illnesses caused by E. coli O157:H7, Salmonella, Campylobacter, and Yersinia.

Specifically to the products we regulate, the CDC reported that illnesses caused by Salmonella Typhimurium, typically associated with meat and poultry, decreased by 38 % from 1996 to 2003. Human illnesses caused by E. coli O157:H7, often associated with ground beef, declined 42 % from 1996 to 2003. The decrease in E. coli O157:H7 infections occurred primarily from 2002 to 2003. Furthermore, cases of campylobacteriosis decreased by 28% in this seven year period as well.

The CDC attributes the changes in the incidence of these infections in part to the control measures implemented by government and industry leaders, enhanced food-safety education efforts, and increased attention by consumer groups and the media. We are hopeful that if we continue on our current course, this reduction will not be just for one year, but will continue from now until we have achieved the greatest reduction possible in the illnesses caused by these pathogens.

The CDC's FoodNet data also show that there were 12.6 cases of Campylobacter and 1.1 cases of E. coli O157:H7 infections per 100,000 in 2003. Assuming that the declines in illnesses caused by these pathogens continue, it is highly likely that we will meet or surpass the Department of Human Health and Services' Healthy People 2010 objectives of 12.3 and 1.0 per 100,000 persons respectively.

But folks, just to meet the Healthy People 2010 goal, we still have much more work to do. These are targets and our true goal is to make every reasonable effort to reduce foodborne illness. Effectively protecting the health of consumers is a moral, legal and business obligation. While we are making considerable progress, USDA is committed to further improving public health by overcoming challenges and using science-based initiatives.

The Salmonella Challenge

One such challenge is Salmonella. Even though the incidence of Salmonella infection has declined, it remains far above its objective. In 2003, there were 14.5 cases of Salmonella infections per 100,000 people. The Healthy People 2010 objective is 6.8 cases per 100,000. We still have quite a way to go in only five years!

If we do our part with respect to meat, poultry and egg products, I believe we stand an excellent chance of meeting, or even surpassing this goal. There is a substantial reduction in Salmonella prevalence to be achieved in ground chicken and turkey.

Also, we are giving further emphasis to fresh broilers. We've seen a gradual upward trend of Salmonella prevalence in this category over the years. For example, from 2002 to 2003, the percent positive regulatory compliance samples increased from

• 11.5% in 2002 to
• 12.8% in 2003.

We need to give careful consideration to what is causing this upward trend, effectively to improve existing interventions, and implement new technologies to reverse it. Keep in mind that the FSIS performance standard for fresh broilers is 20%. However, we still expect the trend in positives to be downward.

If we can work on driving down the prevalence of Salmonella during processing, I believe we can also drive down the prevalence of Campylobacter at the same time. There will be some interventions that will most likely be effective against both microorganisms.

However, the strategies for combating Salmonella and Campylobacter at the production level will most likely be substantially different. This is why I look forward to the presentations and discussions later on the pre-harvest control methods.

Looking Into Campylobacter

FSIS has directed the National Advisory Committee on Microbiological Criteria for Foods to compare the methodologies that the agency used for Campylobacter detection in two previous baseline studies in young chickens. The committee was also tasked with evaluating these baseline studies for the accuracy and precision that they provide in assessing the prevalence and quantity of Campylobacter on chicken carcasses.

A Need for Reliable and Consistent Methodologies

The reason we are directing the NACMCF to examine the baseline studies is that we need to ensure that FSIS has reliable and consistent methodologies for forming them.

Providing the most accurate data from these baselines is absolutely essential for use in our risk assessments, which are the foundation of our science-based policies. Without the most accurate data, we risk having any future Campylobacter control policy misdirected.

A Need for the Most Complete Data

There is another critical piece of the puzzle that we must put into place. We need to detect trends and identify connections between persistence, prevalence, and other factors such as practices employed by plants, seasonal variations and establishment size. Again, it comes down to having the most complete data possible.

Industry data could serve as a very important complement to our own information on Campylobacter. Including data collected by establishments would add robustness to FSIS' information and improve the quality and validity of decisions that are made.

One way we can put this critical piece into our puzzle is to establish a repository to provide data integrity and confidentiality. This data integration principle is actually one of the Office of Food Safety's main initiatives this year. We are currently examining this and anticipate having more details available in the near future.

Conclusion

USDA, along with its partners, has made significant and dramatic improvements in food safety since the implementation of HACCP as the driving component of FSIS' enforcement of the Federal Meat Inspection Act and the Poultry Products Inspection Act. The important complement to HACCP has been the development of science based policies by FSIS and industry's implementation of validated control measures. The number of foodborne illnesses attributed to FSIS-regulated products has declined markedly as have the rates of contamination in regulatory samples.

However, we need to continue applying science and risk-based principles into our policy making to strengthen our food safety infrastructure even further. This includes reevaluating our baseline studies for various microorganisms and the methodologies used to achieve them to stay current with our changing environment.

In summary, we have three key elements to focus on in order to control Campylobacter more effectively in the processing arena.

• First, there is need to improve the existing process controls and implement new validated technologies. Effective interventions for Campylobacter may very well impact on Salmonella reduction.
• Second, we need to ensure that the methodologies we use for Campylobacter detection in baseline studies are consistent and reliable. If they are not, then the data generated does not produce the most effective risk assessments for future decision making.
• Third, integrating industry data with our own sampling data will improve the quality and validity of any future decisions we make.

These, of course, are measures we need to address in the processing stage. Obviously, production control strategies are equally important as well. We learned this through our experiences with E. coli O157:H7, and because of this, we are willing to work with all partners along the farm-to-table chain to reduce the prevalence of Campylobacter.

Thank you for your attention this morning, and I'll be happy to answer any questions you might have.