Address to the American Meat Institute (AMI), New Orleans
[ Hazard Analysis and Critical Control Point at U.S. Food and Drug Administration, Center for Food Safety & Applied Nutrition ]
Dr. Garry McKee, Administrator, Food Safety and Inspection Service
Good morning.
It is a pleasure to be with you today in the great city of New Orleans for your annual meeting. I regret the fact that I will only be in town a short while and unable to take advantage of some of the wonderful restaurants and other famous landmarks in the city.
You would think that someone who administers an agency devoted to “meat” would get a chance to sit down for a decent steak or barbecue, particular here in one of the nation’s leading culinary centers. My loss.
Well, I’ve been in Washington several weeks now and it is an entirely different world than what I’m used to either in the Wyoming Department of Public Health or in my various capacities for the state of Oklahoma.
There is an interesting analogy I’d like to use in order to describe the experience. Typically, when a new president comes to town there is a traditional 100-day “honeymoon” where the Congress and the media give him some slack and refrain from the typical second guessing and back biting.
Well, my staff warned me that the honeymoon period for the FSIS Administrator is traditionally – oh -- about 24 hours. They were right! It went pretty much like this: “Here’s your desk and, oh by the way, you can now handle the largest recall in USDA history. Let us know if you have any questions.”
At that point, I was wondering, what in the heck have I gotten myself into?
As a lifelong public servant, I decided I was up to the challenge even if the stage has become a little larger and the number of people involved multiplied a touch.
When my office door shuts and I get a rare moment alone, I think about the enormity of the responsibility we have at the Food Safety and Inspection Service.
We have jurisdiction over products that generate more than $120 BILLION in sales, or one-third of all consumer spending on food.
Even more interesting is the high level of commitment to protecting public health I have discovered among at FSIS -- from the field inspectors to the headquarters staff in Washington. Also important to remember, the current food safety leadership team is composed mostly of scientists, and science will drive our decision making. I am extremely grateful to be working with such gifted and intelligent people as Dr. Elsa Murano, Under Secretary for Food Safety, and Dr. Merle Pierson, Deputy Under Secretary for Food Safety. And I would be remiss if I didn’t mention, as well, Agriculture Secretary Ann Veneman who has made this all possible because of her deep commitment to protect, and enhance, public health.
Together, we have a historic opportunity to make FSIS a world-class, public health agency that is second to none. And we will.
Philosophy I’d like to spend a moment telling you how we are changing FSIS and our guiding philosophy.
You will hear this from me a lot in the future: Protecting public health is my number one priority.
I have spent my entire career in this field and am devoted to administering under its protocols and scientific foundations.
First of all, I want to emphasize that we are inclusive. We want to maintain a healthy and direct relationship with you, the industry; because I know you care deeply about your work and responsibilities as food providers for the nation’s tables.
We feel the same way about working with others, whether they be industry, advocacy groups, our workforce in the field or the public at large.
I mention this because we want to, and are, working with any and all individuals and groups who will help us accomplish our ambitious food safety goals.
AMI Efforts
And I commend the American Meat Institute for its many initiatives in this area.
I am well aware that the meat and poultry industries, with AMI as part of the leadership team, have been including all links in the production chain to deal with the threat of E. coli O157:H7 as part of an industry-wide effort.
You have recognized, first hand, the problems this pathogen can cause and you are actively seeking solutions.
Among your initiatives is an aggressive program to identify and implement effective intervention technologies and methods to reduce ALL pathogens in the processing cycle. As part of this effort, AMI is pursuing an aggressive research program with both members and other companion trade associations toward this goal.
Finally, AMI has recognized the importance of training, and your efforts to better educate plant employees about HACCP implementation goes to the heart of the solution. Again, thank you for your efforts and I look forward to working with you to improve our food safety system in every way possible.
Collaboration As part of our collaboration, I can assure you that FSIS will NOT just hand out policies or regulations and declare: “You are on your own. Figure it out. Good luck.”
This is particularly true of HACCP. I know FSIS was there to help when the program was first implemented, and we are here now to help plants correctly implement, and run, the program. And let me acknowledge up front, our in-plant inspectors were not as well trained in HACCP as they should have been at the start.
This is a critical need and we will be providing a great deal more field training through our Workforce of the Future initiative. This educational effort for our inspectors will allow us to more easily -- and more effectively -- implement science-based policies and programs within FSIS. The initiative will increase the scientific expertise of our frontline workforce through the introduction of more scientifically-trained consumer safety officers; better use our veterinarians; and improve overall training for inspectors.
HACCP
A few years from now, if you look at the history of HACCP then I think you will see a book with three chapters.
The first covers getting the rule published, which was done in a deliberate, well thought-out, and quite frankly, a very lengthy process covering many years.
The second chapter was implementing this highly technical program in the 6,400 plants where we are present every day. This was a monumental task with many unanticipated plot twists in the four years it was underway. There were times when we lost sight of the huge challenge it was to implement, but we can all appreciate it now.
The third chapter is still being written because that is where we are today. In my mind, it is the most important chapter and the greatest challenge we face.
I can reveal the plot in a phrase: in order to protect the public health we will enforce HACCP.
We will hold industry, and ourselves, responsible for successfully operating under the pathogen reduction/HACCP model. Nothing that we are saying or doing should be a surprise. It’s all there in black and white.
I am here to give fair warning about our intentions. Read the HACCP rule carefully. My message is a clear one: “Know the rule and have it fully incorporated and implemented into your HACCP plan or we will have to take enforcement action.”
Proper and full implementation of HACCP will not only improve plant and company performance but it will make clear how we will identify non-compliance.
A cut-and-paste, or even minimalist, approach to HACCP will no longer suffice. Too often, we have seen plants throw together HACCP plans and forget about them. The cursory, “Oh, this looks like it will work,” approach does nothing. A HACCP plan, standing alone, is useless if all it amounts to is a ream of paper collecting dust on a shelf.
Our message to industry is: Unless you can validate your HACCP plan’s effectiveness then you are out of compliance. The important concept of validation seems to have been lost on some people who blow by this requirement as if it were a mere nuisance.
Lack of Validation
In fact, the Number One omission our Consumer Safety Officers are finding is that plants are not validating their interventions. Consequently, they are not killing pathogens or even reducing them in their plants. Some are not even recognizing that pathogens exist. That’s like playing catch with a hornet’s nest and not recognizing that you might get stung.
Let me be clear: To ignore HACCP is to put the public’s health at risk and that is, simply, unacceptable.
Plants must take responsibility for providing safe food in order for us to improve the public health status of Americans.
We are setting the bar high: Plants need to produce the safest food possible.
In other words, if a meat or poultry company is just doing the absolute minimum then it is failing its responsibility to the public.
Therefore, the most important part of what industry needs to be doing is validation.
Testing
Let me give a couple of examples: Many plants conduct their own laboratory testing of product. However, after confirming a positive for an adulterant, the emphasis is usually on either diverting or calling back the product. That’s not enough under HACCP.
If you have a testing program and are getting positives then you are doing something wrong. Your system is broken and it needs to be repaired. The correction needs to be based on science and its effectiveness must be validated. This may require getting additional people, whether food scientists or people from other areas of expertise, into the plant to get it right. Just as there is no room for junk science; there is also no room for junk HACCP.
Testing, by itself, is not the answer, but an indicator of how the HACCP system is working. Positive test results are strong and obvious warning signs--even stop signs. If plants ignore pathogen positives then they are not producing safe food.
It’s not debatable.
Prevalence
I think you can appreciate the importance of our approach when, for example, you take a look at the E. coli O157:H7 landscape.
In our recent initiative, we reference data that indicate E. coli O157:H7 is more prevalent than previously believed. The citations backing up this conclusion, by the way, can all be found in the Federal Register notice.
Last year, for instance, a study published in the Journal of Food Protection on the rate of infection in cattle herds sampled, found that 63% had at least one animal testing positive for E. coli O157:H7. Granted, the researchers considered the ENTIRE herd positive even if only ONE animal tested positive. Yet, we know how easily the meat from one of these animals can be co-mingled with the others.
Another recent study from the USDA’s Agricultural Research Service (ARS) found that E. coli O157:H7 was present on 43% of the pre-evisceration carcasses sampled. While this finding is at the beginning of production, and the contamination rate should decrease as carcasses move down the line, it does present the magnitude of the challenge.
The news is similar at other stages of processing. Combo bins surveyed by ARS that contained meat from steers and heifers were found to have an E. coli O157:H7 prevalence rate average of about 40%, ranging from 20% to 60%. Combo bins with meat from culled cattle, or animals removed from dairy herds, had a lower prevalence -- or about 10%. Nevertheless, the difference between the two groups of animals is negligible because the cattle are often processed at the same time and rarely segregated.
We know, however, that the mixing of combo bin contents disperses the pathogen and results in ground product with a lower concentration of E. coli O157:H7 but a higher prevalence of contamination than in the original combo bins. We have seen preliminary risks assessment estimates that suggest nearly 90% -- yes 90% -- of grinder loads, had at least one E. coli O157:H7 organism present.
It is also important to recognize the frequent seasonality of E. coli O157:H7. We now know its prevalence may be highest from April to September. During these months, companies need to implement additional interventions or conduct more frequent verification activities.
One of the ironies of the increase in E. coli O157:H7 prevalence is that we are seeing declines in the number of overall foodborne illnesses related to other pathogens since 1996, according to The Centers for Disease Control and Prevention. For instance:
Yersinia 49% decrease Listeria 35% decrease Shigella 35% decrease Campylobacter 27% decrease Salmonella 15% decrease
The CDC attributed the declines in part to the implementation of HACCP. So, we know it works. But there are many more benefits left to realize from HACCP-- such as with Listeria monocytogenes, a pathogen we have been contending with for several weeks now.
Listeria
In light of the last week’s massive recall of ready-to-eat poultry products, Agriculture Secretary Veneman has instructed us to develop a plan to strengthen our current testing program for this organism. The revision will include a new testing protocol for Listeria monocytogenes that will focus on those establishments that produce the vast majority of products, thereby increasing the number of samples taken and testing being conducted at each establishment.
This testing will include product as well as environmental samples. We will also require that establishments producing ready-to-eat products reassess their HACCP plans to account for the likelihood of contamination with Listeria monocytogenes if they have not already done so. I am pleased to say that we have known for some time that most plants have reassessed for Listeria monocytogenes. And we are anticipating the day when the figure is 100%.
For those who have yet to take the plunge I must ask: Is it unreasonable to think that Listeria monocytogenes MAY be a hazard in ready-to-eat product and should be considered in HACCP plans?
We are also working to complete a rule that was proposed last year for Listeria monocytogenes in ready-to-eat meats. A risk assessment, which is required and critical to implementation of this rule, is in the final stages of completion.
To gather more information and strengthen our approach to Listeria monocytogenes, we are holding a summit on November 18th in Washington, DC. I invite and encourage any of you who may be interested, to attend.
Recalls
The recent events repeatedly underscore the need to focus on prevention through verification. Recalls, for instance, are a last resort. They indicate a failure in the system; not a cure or solution. We must strive for improvement and I hope to see the day when recalls become rare occurrence for us both.
While we will continue to request voluntary recalls, they are not the way to get us to the next level of food safety in this country. Again, they are a glaring stop sign warning us to go back to the repair shop rather than risking an even more damaging turn of events. I’m sure you agree that there is a better way and that is prevention.
Now, while recalls are unfortunate, we are improving the process whenever possible. For instance, on July 31, we finalized a model Memorandum of Understanding that can be used to share recall information with the states affected. We will provide a firm’s distribution list in the event of a recall to those states that elect to sign the MOU. We are sending a strong signal that FSIS is always working to improve its systems when we discover a weakness or vulnerability.
This MOU will inform more people that a recall is taking place and get suspect product off the market as quickly as possible. We believe this is an important tool that demonstrates we are working to improve our systems at the same time we are calling on you to do the same. Faster notification will allow for better communication and coordination between FSIS and the numerous state and federal agencies that are involved in product recalls.
Consumer Safety Officers
Sometimes prevention is not an easy pill to swallow. We have been getting complaints from some establishments that the in-plant inspectors will say a particular HACCP plan is fine. Then an FSIS consumer safety officer arrives and delivers the news that it is not fine; that it needs work.
I can see where this kind of dual message can be disconcerting and we are working hard to correct this unhelpful cross talk.
But there is another way to look at it.
Plants should be thankful when CSOs come in and identify a problem. They’ve just benefited from an independent expert providing important scientific guidance on how to improve performance. That’s why we have our highly trained CSOs out there: They look at HACCP plans and are available to help prevent problems.
Supervisors
It will take time to get where we want to be. No one is naïve about the challenge before us. But we are well on our way.
Several days ago, I spent a week with more than 300 of our District Managers and Supervisors from around the country discussing our issues and listening to their comments and concerns. I believe we have complete buy-in for HACCP’s Chapter Three, “The Enforcement.”
I spent a lot of time and effort articulating my expectations and I EXPECT them to protect the public health.
My impression is that everyone left the conference renewed and excited about our important work ahead.
As we realize our mission, I want to ask you, in industry, to join us in this challenge. You have the personnel and resources to help improve food safety, and they must be implemented to the fullness extent possible.
Let’s take that mission to the next level and create a new generation of food safety policy and protection.
I am very encouraged that industry is working together to find solutions for controlling pathogens and seeking to improve intervention strategies. We will work together to find solutions to the challenges we both face. Let’s keep the dialogue going and be able to sit across the table from one another dedicated to serving our most important audience: The American people.
Closing
Again, I want to thank you for the opportunity to spend time with you discussing today’s Food Safety and Inspection service. Thank you.
source: http://www.fsis.usda.gov/oa/speeches/2002/gm_ami.htm 7dec02
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