|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
U.S. Department of Agriculture
Food Safety and Inspection Service
Remarks prepared for delivery and presented via videotape by Thomas J. Billy, Administrator, Food Safety and Inspection Service, before the Fisheries Council of Canada, October 6, 1999, Halifax, Nova Scotia.
Hello and thank you. It's good to be here--though I wish I were really with you instead of a "virtual" presence.
This is a crowd with which I feel many alliances. I cut my teeth on the science and regulation of seafood, and have more recently been involved with meat and poultry regulation at the Food Safety and Inspection Service (FSIS). And, as chairman of Codex, I see the need for international cooperation to keep all consumers worldwide safe from foodborne illnesses. However, despite my many interests, I will center my remarks around what we are doing at FSIS to ensure a safe meat and poultry supply, and let the experts from FDA address the most current regulations about seafood in the US. I will also let my Codex colleagues address our most recent international advances, standards and successes with HACCP.
At FSIS, we have been undergoing many exciting--and difficult--changes in the way meat and poultry is inspected and the industry is regulated. It is exciting to be at the helm at a time of such great change. I have also discovered that changing almost 100 years of a culture of product inspection is a lot more like changing the course of an ocean liner than a Jet Ski! But first, the successes.
Since 1995, FSIS has been moving towards incorporating Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) systems. We knew from the start that a few, small changes would not be enough. We needed to fundamentally change production and inspection for a maximum effect. To do so, we have focused on three areas:
One: We knew there was a need to focus more heavily on pathogenic microorganisms on raw meat and poultry products and to institute a more preventive approach. Pathogens provide the largest risk to the public, but are the most difficult to control. Traditional inspection, which focuses on organoleptic--sensory--inspection of products is not suited for what science has shown us is the greatest risk. Since you can't see, touch or (in most cases) smell pathogens, the only way to truly address these hazards is through prevention and process control. HACCP is also a way for plants producing prepared foods to address pathogens and meet our zero tolerance for pathogens in ready-to-eat products.
Two: We knew there was a need to set pathogen performance standards for products. Although we readily accept that raw products are going to have some pathogens, we also have addressed the need to reduce their prevalence on raw products. As an indicator organism, we chose Salmonella, and repeated sets of tests are one measure of a plant's success in process control. As HACCP is implemented and baseline levels decrease, we plan on continuously ratcheting down the performance standard--much like the limbo dance.
And three: We also had to change more than just our regulations--we needed to better define the responsibility of industry and our role in inspection. Industry is responsible for producing and marketing products that are safe, unadulterated and properly packaged and labeled. FSIS inspectors are responsible for verifying that industry has fulfilled its obligation to consumers. This is a very important distinction--and a difficult culture to change. But, we continue to place the responsibility squarely on the shoulders of industry to produce wholesome products, which allows us to use limited government resources most efficiently and effectively, to verify the safety of meat and poultry products and compliance with our regulations.
These core ideas are at the heart of the Pathogen Reduction and Hazard Analysis and Critical Control Points rule. The key provisions of the rule are that:
Implementation of HACCP for the meat and poultry industry began in January of 1998 and will be completed in January 2000. We decided to phase in implementation by plant size, with the largest plants meeting the requirements first. This phased implementation has allowed the agency time to train our employees for their new roles, and given the small and very small plants extra time to comply. We recognized early on that the smaller plants may lack the resources to quickly change, so we have also provided technical assistance including a toll-free hotline, workshops, generic model plans, a nationwide network of contacts, and, for the very small plants, a self-study training and HACCP plan development program.
As we are implementing HACCP in meat and poultry plants, HACCP has gained national and international recognition by scientific authorities and is used widely to produce safer food. Codex has also embraced HACCP as an international strategy, and it forms a solid foundation for facilitating trade.
Although implementation in U.S. meat and poultry plants is still underway, we have some preliminary data to support the direction we've taken.
First, we have data on how well plants have complied with the HACCP requirements. Our most recent data for 1999--including large and small plants-- show a compliance rate of 96 percent with the Pathogen Reduction-HACCP rule. And, we have every confidence in the success of very small plant implementation this coming January.
Second, data from our testing to verify compliance with our Salmonella performance standards reflect progress. I am pleased, and very proud that industry has risen to meet the challenges we have raised. The vast majority of plants have successfully met the performance standards and we have seen a dramatic reduction in the prevalence of Salmonella on raw product. For example, the numbers for broilers have consistently shown a 50 percent drop from pre-HACCP baseline figures.
Third, data released this year from the U.S. foodborne disease surveillance system show that during 1998, the rate of illnesses caused by Campylobacter and Salmonella declined nationwide. These data provide hope that improvements industry and we are making through new food safety systems and regulations, research, new technology, and education, are contributing to the reduction in the incidence of foodborne disease.
All of these changes, however, have not come easily, and we have had some bumps. We continue to work with our own inspection staff on changing the culture and the expectations, but recognize that this will take some time. We continue discussions with our bargaining unit and hope to avoid the inside of courtrooms as much as possible.
But we are not stopping, nor even taking time to catch our breath.
In October, we began the models testing phase of the HACCP Inspection Models Project to further integrate the principles of HACCP along the slaughter lines. In this respect, I am pleased to inform you the Federal Judge has ruled in our favor regarding the case filed by our inspectors union. For about 25 volunteer plants that slaughter certain classes of young, healthy animals, we will remove our inspectors from fixed points on the slaughter line and instead given them oversight and verification inspection roles. The volunteer plants have agreed to shoulder full responsibility for process control, consistent with HACCP, which frees our inspectors to verify that the plant is producing food that is safe for the public.
Twenty-eight plants have volunteered to take part in this experiment, which began last fall with baseline data collection. We have taken baseline data under current inspection systems and will compare these data with results during the experimental phase. Products produced under the models phase must be at least equal to products produced under the current system in order to deem the experiment a success--and provide the data to support regulatory changes to permanently institute these changes.
Hand-in-hand with the slaughter models program is the in-distribution model. With inspectors no longer responsible for product (i.e. carcass) sorting, which should be the plant's responsibility, we can redeploy some of our resources to other points in the continuum--including distribution points beyond the plant. These employees will foster closer relationships with our state and local counterparts. And consumer education is reaching into homes--to stretch our efforts to the "fork" end of the line.
Looking in the other direction towards the farm, we are also working with producer groups and states to develop and encourage measures to reduce food safety hazards associated with animals presented for slaughter. We believe that the voluntary application of food safety assurance programs, based on HACCP principles, has a role in reducing risks at this level.
Together, all of these efforts are evolving into a seamless farm-to-fork food safety system.
While all of these efforts represent an enormous amount of work, in some ways we have it easier because there is less variability in the industry FSIS regulates than in the seafood industry. Certainly a cow and a chicken are vastly different, but they are still more similar than a shark and a shellfish. With 300-500 species grouped under "seafood," the variations of types of hazard are virtually limitless. For example, the hazards presented by scombrotoxin-forming species necessitate careful handling of tuna and mahi-mahi; whereas parasites can plague shellfish and other species; and toxin-producing phytoplankton (e.g. ciguatera) can affect a broad spectrum of species from a given location.
Most of the meat or poultry animals slaughtered for food in the United States are raised under extremely controlled conditions, and present fairly uniform hazards. By contrast, there can be wide environmental variation where most seafood animals live.
While there is some variability among farms and among regions of the country, these differences are vastly less than represented by the hazards encountered in seafood living near shore versus off shore, freshwater versus seawater, in water off populated coasts versus unpopulated areas, and tropical versus cold water. The effects of farm nutrients, pesticides, sewage running off the land, offshore spills, parasites, and natural phenomena such as red tide, can present countless hazards for people eating the fish from those waters.
And, furthermore, while many meat or poultry plants specialize not only in one species, but one class of animals--slaughtering only animals the same age, size and history--a single boatload of seafood can contain many different species of fish representing numerous different hazards.
Last, but not least, is that FSIS has jurisdiction in slaughter plants--and we conduct both ante- and post-mortem inspection. Fishing boats in most countries have no such inspection. Seafood processors must rely on their suppliers to provide accurate information about the hazards presented by the species on board and based on where they were harvested and how they were subsequently handled.
Despite all these differences, there are some important similarities. The most obvious of which is that HACCP is adaptable to all different environments and situations. Each processor should have a HACCP plan unique to his or her products.
A second similarity is that in the seafood industry, like in the meat and poultry industry, the burden is on industry to produce product that is safe and wholesome. The role of the government is not to produce the safe food, but to set standards and verify that plants are operating in a manner that meets those standards.
And third, no matter what the product, HACCP plans should constantly be adapted as new hazards come to light. In all industries, a HACCP plan should be a living document, changing as situations change, as new hazards present, and as new technology becomes available to either find or prevent hazards.
Implementing HACCP is not simply a goal, but a process. At FSIS, while we phase in HACCP by plant size, we're looking at more thoroughly adopting its principles through the slaughter and in-distribution models projects. Our next focus will be to continuously prompt industry to improve the quality of those plans.
We are doing this on a large scale. For example, following an outbreak caused by Listeria monocytogenes in hot dogs and luncheon meats, we've mandated that producers of ready-to-eat products re-evaluate their HACCP plans, paying particular attention to this pathogen. And beyond focusing on entire segments of industry, we are also revamping HACCP on a small scale--one plant at a time. We've developed a protocol for an interdisciplinary team to analyze a plant's HACCP plan in extraordinary detail.
We also intend to improve the safety of products by ratcheting down the Salmonella performance standard for raw products. Once HACCP is implemented, we expect the baseline prevalence of the bacteria to be lower--and when that is achieved, the performance standard will also decline. Since we know that Salmonella is only one of many possible pathogens, we are studying the feasibility and the science behind the possibility of also instituting a performance standard for Campylobacter, the leading cause of sporadic cases of foodborne illness.
In order to have the scientific underpinnings to best focus our resources on reducing the risks that have the greatest consequence for human health; several risk assessments are underway. Risk assessments also help us identify areas where further research is needed, provide industry information that can increase the effectiveness of their HACCP plans, and help us prove internationally the strength of our food safety systems in protecting public health. We have fairly recently completed a risk assessment for Salmonella Enteritidis in eggs and expect some preliminary results this fall from an assessment FSIS has underway on E. coli O157:H7. FSIS is also working with partners at FDA on a risk assessment of Listeria monocytogenes and have an agreement with the Harvard University School of Public Health for a BSE assessment.
And, finally, as we implement broad scale changes within the slaughter and processing plants, we are broadening our view back to the farm and forward as far as the consumer. Ultimately, we recognize that every person along each step of the continuum bears a part of the responsibility for safer food for everyone.
I would like to take this opportunity to send my regards to many former colleagues and friends participating in the conference. I was really looking forward to renewing acquaintances and telling old "war" stories. However, an incredible international travel schedule prevented me from being there. Also, I would like to acknowledge the award that was presented yesterday to Jim Brooker by the International Association of Fish Inspectors. His dream is coming true and I couldnt be happier for him.
For Further Information:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704
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