Remarks prepared for delivery by Dr. Barbara Masters, Acting Administrator, Food Safety and Inspection Service, at the American Association of Meat Processors' 65th American Convention of Meat Processors and Suppliers' Exhibition, July 15, 2004 in Grand Rapids, Michigan.

Introduction

Good morning. It is a pleasure to be here. I know as members of the American Association of Meat Processors (AAMP), your companies have provided safe and high quality meat and meat products for generations. Your plants are more than just a business - they are a way of life. I compliment all of you for taking the time to be here at AAMP's annual conference to discuss the many issues we face.

The title of this segment of today's agenda is "Can You Survive?" In light of this question, I want to tell you about another American industry that is not only surviving but thriving - U.S. winemakers. I think we all can learn from their success story.

U.S. wineries have only been around for a few hundred years in comparison to thousand year old vineyards in France and Italy, but they produce some of the finest wines in the world. Over the past few decades, science has advanced the noble art of winemaking. Winemakers resisted the move at first, preferring to follow years of sacred tradition rather than take advantage of modern innovations. But soon wineries of all sizes began using basic automation technology to aid in production-first to automate the crushing and bottling processes and then to track the movement of the grapes from harvest through bottling. Today, U.S. wineries are on the leading edge, employing science and technology to improve the taste and safety of their product as well as their bottom line.

U.S. wineries, just like meat and poultry processors and slaughterers, come in all shapes and sizes and are frequently a family business passed down from generation to generation. As an industry, they made the decision to embrace science and technology, and it proved to be very fruitful for them - pun intended. Today U.S. winemakers are not just winning awards and garnering international acclaim. Last year alone, U.S. wine exports increased 17 percent in value to $643 million dollars in winery revenues, and increased 29 percent in volume to 96 million gallons.

This account shows how winemakers - many of them small businesses like yourselves - were able to meld a cultural and traditional art with science and technology to produce not only a superior product but also to become very profitable. I know many of you are doing the same, and that you represent many of the leaders in these efforts. In many cases meat processing has been handed down from generation to generation and is an art form in its own right. Those of us here appreciate the tradition and art of this trade, and we want to ensure that it thrives well into the future.

The path for this success includes accepting and using the latest science to our advantage. Let's face it, the crux of our challenge in this industry centers on combating pathogens, many of which have predated our existence for over two billion years and some that have yet to emerge. With their long history of survival and adaptability to changing environments, it is a given that we will continue to be challenged in containing these harmful bacteria.

However, as pathogens evolve, so does science. By embracing innovation, we can employ effective counter measures to stay one step ahead of evolving pathogens to improve food safety while maintaining the essence and tradition of this art. Just as pathogens are living, breathing and evolving, we need to view HACCP as a living, breathing system in its own right. It has to be "alive" and must "evolve" to work effectively.

As with the U.S. vineyards I mentioned, the melding of science with the art of your craft is showing significant success in your industry. I'd like to share with you today some examples of how government and industry can work together using science in meat and poultry processing.

FSIS Today: Significant Food Safety Advancements

An effective gauge of how our policies and your practices are working is looking at how public health is impacted. In April, 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 you produce and 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!

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 on until we have achieved the greatest reduction possible in the illnesses caused by these pathogens.

E. coli O157:H7
E. coli O157:H7 really is a good example of how our hard work is yielding results. As I just mentioned the CDC data show public health improvements, but in addition, we are seeing a significant drop in the percentage of O157:H7 positive regulatory samples in ground beef as well. In 2003, of the O157:H7 samples collected and analyzed, there was a 60% reduction in the number of positive results from 2002. I think we can all take credit for this success. FSIS required all beef establishments to reassess their HACCP plans.

Then our scientifically trained personnel conducted the first-ever comprehensive reviews of the reassessed HACCP plans in over 1700 beef establishments. Sixty two percent of those plants made major improvements based on their own reassessments, and 60% had added O157:H7 as a pathogen likely to occur. This is a definite improvement and another indicator that science-based policies and control are working.

Let's look at this another way by comparing annual results from our microbiological testing program for E. coli O157:H7.

• In 2001, our testing program yielded 59 positive results;
• In 2002, there were 55 positive results;
• In 2003, there were 20; and
• So far this year, there have been only seven!

This certainly is a credible testament to the value of teamwork in preventing foodborne illness.

Listeria monocytogenes
The effectiveness of using science is also evident when we look at Listeria monocytogenes (Lm). Late last year, we released data that showed a one-year, 25 percent drop in the percentage of positive Lm regulatory samples from the year before. That is a 70 percent decline compared with years prior to the implementation of HACCP. We are cautiously optimistic that this downward trend will continue, due to the regulation issued last June for establishments producing ready-to-eat products where Lm is a concern.

Salmonella
As for Salmonella, we issued new instructions for utilizing the Salmonella performance standards as an indicator for verifying food safety systems. Under these new procedures, instead of waiting for two consecutive failures of tests to trigger an in-depth review of plant SSOP and HACCP plans, reviews are initiated after any series of tests fails to meet a standard.

This process and other science-based initiatives have 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 and represents a downward trend in positive results 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 downward trend.

Initiatives

These are certainly positive indicators of success; however, science continues to evolve, as does our common nemesis - the pathogen. After a thorough assessment last year of our progress, FSIS outlined initiatives to make sure we continue building on our public health regulatory model. These steps are described in a new document FSIS released just yesterday - Fulfilling the Vision: Initiatives in Protecting Public Health - that describes many of the actions the agency is currently taking in pursuit of our food safety mission. This document is currently available on our Web site. I would like to share with you a few of these initiatives.

Training
For the past year, training has been and will continue to be at the top of our priority list. We are intensively training a large segment of our field force in sanitation procedures and HACCP principles based on the type of products being produced at the establishments where inspectors are assigned.

We expect to have this segment of our workforce fully trained by the end of fiscal year 2005. We have also successfully launched training for newly hired Public Health Veterinarians and training for newly hired inspectors will start by the end of this fiscal year. We are also going back four years to train "new hires" to ensure any employees that did not receive this training are fully equipped. I could spend my entire time allotment on all of our training initiatives and encourage you to ask questions or visit our Web site to learn more.

I know there is a desire for industry to have opportunities to attend FSIS training. For the past two years, we have offered a review of FSIS training to industry, through a meeting sponsored by the International HACCP Alliance. Two years ago, the focus was on the Consumer Safety Officer training. Last year, the focus was on the Enforcement, Investigations and Analysis Officer training and the Food Safety Regulatory Essentials training. Based on the positive response, we are currently working with the International HACCP Alliance to offer another such meeting. We do not yet have the details, but expect that it will take place before the end of the fiscal year.

Outreach
Conducting an innovative outreach program to provide all of FSIS' stakeholders with essential agency information is an important component of our public health regulatory effort. This includes holding a variety of public meetings to receive input from all stakeholders who have an interest in food safety. This effort is important for both the risk management and risk communication components of the risk analysis framework. We need the input from industry, consumer groups, academia and others to help develop our regulations and further refine our policies and educational programs. We want to have a genuine dialogue and be as transparent as possible.

As you know, FSIS recently issued its E. coli O157:H7 directive. As we have done with other recent agency initiatives including Lm and BSE, FSIS is holding instructive workshops around the country to discuss information contained in these policies. These workshops are an opportunity for FSIS to work together with industry to better understand and implement the directives. We are also continuing our efforts to make these teaching workshops available to as many people as possible. For example, just this past weekend we tried a web cast of the e coli workshops. It was a great success with over 200 people across the country participating via computer. We hope to be able to offer more of these in the future.

We are continuing to search for ways to help small and very small plants implement the changes science demands. The wine making industry struggled with this challenge and by working together they were able to overcome it. In this spirit, the FSIS Office of Strategic Initiatives, Partnership and Outreach is devoted to serving the needs of small and very small plants. I encourage you to take advantage of this resource that is available to all of you. We have members of our staff here at the FSIS booth in the AAMP exhibit hall - please stop by and let them know how we can assist you.

Strengthening Oversight of Recalls
Another recently issued directive relates to strengthening oversight of recalls. Our scientific measures are all designed to prevent product recalls. However, in the unfortunate circumstance an adulterated product is in commerce, FSIS revised its recall directive to improve this process. The changes to the directive are designed to ensure that recalls are performed quickly and efficiently. The agency is also increasing the number of effectiveness checks that it carries out during Class I recalls, those that pose the greatest potential of adverse health consequences. The directive also provides information on the new risk-based system the agency will use for determining the scope of effectiveness checks.

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. This is a strong indicator that our scientifically-based policies and programs are working - and that you, the industry, are making a difference to ensure that the American public receives the safest food possible.

Strengthening State Reviews
I would like to take a minute to mention the state meat and poultry inspection programs. These are an integral part of the nation's food safety system. State programs must put in place their own testing programs for pathogens in ready-to-eat products, animal drug residues; and specified risk materials.

We have updated and strengthened policy and procedures for reviewing state meat and poultry inspection programs. In light of evolving food safety initiatives, we are reassessing the criteria by which we evaluate state programs, including the need to better coordinate state activities with those of other food safety agencies.

The goal is to update the cooperative state program criteria and procedures and corresponding FSIS activities. To date, 28 states have state programs that operate under a cooperative agreement with FSIS. The new comprehensive state review process has two parts:

• First, each state performed a self-assessment that was submitted to FSIS for review;
• Second, on-site visits began last fall to determine whether the states are maintaining "at least equal to" programs. Multi-disciplinary review teams conducted on-site verification reviews in state offices, laboratories, and a sample of establishments. All 28 state programs will eventually have an on site verification review.

Bovine Spongiform Encephalopathy (BSE)
In light of the timing of this meeting - I felt it appropriate to briefly mention BSE. Ensuring that our policies and initiatives evolve with the latest science is especially important when we look at BSE. The measures that the agency has taken to further prevent BSE demonstrate how committed we are to protecting public health and improving our food safety system through sound, science-based measures.

Just last week, USDA and FDA announced that comments are being sought on further measures to mitigate the risk to human and animal health of BSE in the United States. The three measures announced are:

• A joint USDA/FDA notice that asks for public comment on additional preventive actions concerning BSE; relative to FSIS, primary questions for comment include equivalency, the small intestine as a specified risk material, and sanitation.
• An interim final rule that prohibits the use of certain cattle-derived materials in the production of and as ingredients in all human food and cosmetics; and
• A proposed FDA rule on recordkeeping requirements for the interim final rule relating to this ban.

This is addition to the interim final rules that FSIS has in place. As an update, FSIS is currently evaluating the over 20,000 comments they received on the interim final rules.

The American public remains confident in the U.S. meat supply - and with good reason. Organizations such as AAMP 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 last December as we addressed the positive BSE finding. The coordination between all parties, including AAMP members, was a key factor in ensuring public confidence in the safety of the meat supply.

Closing

In closing, AAMP's history is a proud one, and your association has included many of the most forward thinking members in food processing. You continue to be the leaders of your industry. We all know that protecting public health through safe and wholesome food is not accomplished through one isolated action. We are all in this together.

Do I believe you can survive? Absolutely. By continuing to work together to address emerging issues, I believe your industry will not only survive, but thrive.

I urge you to continue your leadership so that as you hone the craft and art of your work, we can all continue to enjoy success similar to the winemakers. I am aware that you had several award winners at the recent International meat trade fairs. You have all been part of the successes I mentioned in the decreasing human illnesses. And I know that by working together, we will only continue to grow stronger.

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. Again I urge you to visit our FSIS exhibit, take advantage of opportunities provided through our Strategic Initiatives, Partnerships, and Outreach Staff, and visit our Web site. I'll be happy to answer any questions you might have.