|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Remarks prepared for delivery by Thomas J. Billy, Administrator, Food Safety and Inspection Service, before the National Policy Association, September 25, 1997, Washington, D.C.
Good morning. It's a pleasure to be here today to discuss risk assessment and its role in food safety policy. This is a timely topic for me to address because we are in the beginning stages of integrating risk assessments into our food safety program.
Let me begin by briefly describing our food safety program. The Food Safety and Inspection Service (FSIS) is the USDA agency responsible for ensuring the safety of meat, poultry, and egg products. Our inspectors are stationed at approximately 6,500 privately-owned slaughter and processing establishments across the country to verify that the industry is complying with Federal inspection laws and regulations.
USDA faced a significant food safety crisis in 1993 following an outbreak of E. coli O157:H7--a virulent pathogen--that was attributed to undercooked hamburgers. The Department knew for some time that changes were needed to address new food safety concerns. In fact, almost 15 years ago, USDA asked the National Academy of Sciences (NAS) to evaluate the scientific basis of its food safety programs. Despite the overwhelming scientific support for change that emerged from NAS, progress was slow until the 1993 outbreak, which mobilized support for change among regulators, industry, and consumers.
Following the outbreak, USDA began an intensive and comprehensive overhaul of its food safety program, which is now a work in progress.
One of the guiding principles during this process of reinvention was the need to target the most significant risks in the food supply. A major weakness in the traditional inspection system was its inability to deal directly with pathogenic microorganisms, particularly on raw products. The traditional system relied heavily on organoleptic inspection--sight, touch, and smell--which is ineffective in detecting microbial pathogens.
The time had come to require plants to prevent or control contamination through process control and science-based, anti-microbial technologies, rather than on relying on traditional detection methods to find food safety problems after they had occurred. The time had also come for government to set food safety performance standards--not just for processed products, as had been done in the past, but for raw products as well. We believe that performance standards for pathogenic microorganisms, used in conjunction with preventative process control systems, are the most powerful and effective tools available for bringing about improvement.
In developing our strategy for change, we relied heavily on a public process to ensure that all interested parties had the opportunity to provide input. We held--and continue to hold--countless public meetings on every aspect of our food safety strategy.
Public participation is extremely important in allowing us to achieve our food safety goals. We know that public policy that is made without the input of all interested parties will likely fail.
The public process ensures that common ground is reached, and that our policies are scientifically sound. This is very important to the success of our food safety initiatives, as well as to maintaining public confidence in our programs.
The result of our planning, and the public rulemaking process that followed, was a regulatory strategy that encompassed major changes in how plants operate, as well as changes in how we operate as a regulatory agency. On July 25, 1996, we reached a milestone in our strategy for change with publication of our final rule on Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP).
The rule is significant in that plants are responsible for developing and adopting a HACCP program to ensure they have in place science-based controls to prevent and reduce food safety hazards. HACCP is a conceptually simple system plants can use to identify and evaluate the food safety hazards that affect the safety of their products, institute controls necessary to prevent those hazards from occurring or keeping them within acceptable limits, monitor the performance of controls, and maintain records routinely.
The rule also sets performance standards for pathogenic microorganisms. Food safety performance standards, in the form of tolerances or other limits, have been an important feature of the food safety regulatory system for chemical residues and for pathogenic microorganisms in ready-to-eat products. However, performance standards have not been incorporated into the regulatory system for pathogens on raw meat and poultry products.
The rule specifies that slaughter plants and plants that produce ground products have to meet performance standards for Salmonella. Salmonella was selected as the target organism because it is the most common cause of foodborne illness associated with meat and poultry products, and interventions targeted at reducing Salmonella may be beneficial in reducing contamination by other enteric pathogens.
In addition, all plants are required to implement Standard Operating Procedures for Sanitation, and slaughter plants are required to routinely test products for generic E. coli, an indicator of fecal contamination.
We are now in the process of implementing the final rule. The provisions for Standard Operating Procedures for Sanitation and testing for generic E. coli are already in place. The provisions for HACCP and Salmonella performance standards are being phased in based on plant size. In January, the largest plants will be required to implement HACCP and meet the Salmonella performance standards, and by January 2000, implementation will be complete in all plants.
To complement these changes within plants, we also are working with other government agencies, industry, and academia to develop and take steps to improve food safety from farm-to-table. FSIS has historically focused on the manufacturing of meat and poultry products through its inspection program, but the Agency's public health mandate requires that the Agency also consider pre- and post- processing hazards as part of a comprehensive strategy to prevent foodborne illness.
With HACCP and our farm-to-table strategy, we have provided a framework for significant food safety improvements. But we have much more work ahead. If we are to focus on the true risks in the food supply, we must know what those risks are and their significance. That is how risk assessment fits into our food safety strategy.
There are many reasons why we need risk assessments.
First, we can better target our resources if we know what hazards are associated with certain foods and the risk to the public that they represent. For instance, we are now working with FDA and others on a risk assessment for Salmonella enteriditis in eggs and processed egg products to help us determine where, along the farm-to-table chain, contamination is most likely to occur and what steps--regulatory, educational, and voluntary--we can take to best address this public health problem.
Second, we need to know the impact of control strategies on risks in food so we can ensure that industry is taking the necessary steps to control hazards through HACCP systems. In the future, FSIS and industry, using computers, will be able to evaluate, through risk assessment models, a change in a plant's processing procedures and determine if the change will reduce risk. If so, the HACCP plan can be adjusted to prevent, eliminate, or reduce the hazard. A rapid feedback system such as this is not yet practical, but it is a future goal.
Third, we can use risk assessments to set food safety performance standards. Generally, we have not been able to set performance standards with respect to pathogenic microorganisms because we have been constrained by the lack of a scientific basis for determining the levels at which specific pathogens will cause illness. The final rule on Pathogen Reduction and HACCP, therefore, sets performance standards for Salmonella in raw products based on the nationwide prevalence of Salmonella in various product classes. As industry performance improves, standards will be tightened. Risk assessment, based on better information on specific levels of Salmonella and other pathogens that make people sick, will allow us to set quantitative public health standards for Salmonella and additional standards for other pathogens.
While it is clear that microbial risk assessments can play an important role, the application of risk assessment techniques to microbial food safety issues is a significant challenge. Unlike most chemical residues, the levels of bacteria in food are not constant; they can change drastically as the result of growth or inactivation as well as toxin production. In addition, quantitative risk assessment for pathogenic microorganisms is complicated by the wide variability in susceptibility to particular pathogens among individuals and groups of individuals in the population. It is well known, for instance, that the young and elderly are at significantly greater risk of serious illness or death from E. coli O157:H7 than the general population.
The good news is that recent advances in predictive microbiology and the systematic collection of baseline data on the presence of pathogenic bacteria in foods have begun to allow the first quantitative microbial risk assessments. FSIS is not a research Agency, but we believe our role is to stimulate the scientific research needed to develop quantitative risk assessment methods, and support the studies needed to fill data gaps that prevent these risk assessments.
That is why we are working closely with USDA agencies such as the Office of Risk Assessment and Cost-Benefit Analysis and the Economic Research Service, the Food and Drug Administration, and with the private sector, to guide research to meet our needs for risk assessment.
Our new food safety strategy will help us to meet our primary goal--reducing the incidence of foodborne illness. But it also provides a solid foundation for facilitating international trade. On a very basic level, our strategy is consistent with the WTO agreement, which requires countries to ensure that their sanitary or phytosanitary measures are based on science and risk assessment principles.
But our strategy does much more than just conform to world trade principles. Through performance standards, we have established a level of protection that is based on science. And through HACCP, we have established a system of process control, with documentation, for meeting those standards.
The combination of performance standards and HACCP will enable us to objectively demonstrate that the level of protection the U.S. system provides is science-based, addresses likely hazards, and is equivalent to foreign requirements. Risk assessment will allow public health refinements to the preventative control system we have established and help to address trade disputes that are not based on science.
I'd like to close by discussing the recent recall of ground beef because of contamination with E. coli O157:H7. This recall was not a test of HACCP and performance standards for microbial pathogens because we are still in the process of implementing these provisions. However, I believe a good HACCP plan would have identified the potential hazards involving the practice of recycling the previous day's production into the next day's production, and adding rework randomly into future production. It would have required greater focus on hazards associated with raw materials and steps to minimize those risks. And a good HACCP plan would provide consistent, reliable records.
But we can see some significant differences between the 1993 and recent outbreak, nonetheless.
First, we found the problem quickly this time because of our new FoodNet active surveillance approach to tracking foodborne illness. The program collects foodborne illness incidence data from seven sites around the country. The health department in Colorado, where the outbreak occurred, notified FSIS of several confirmed cases of illness caused by E. coli O157:H7. One of our laboratories isolated the pathogen from an opened package of patties collected from the patient's freezer and unopened packages from the marketplace. With modern fingerprinting technology, we confirmed that the patient isolates matched the meat isolates.
Second, because of our improved public health focus, we quickly removed contaminated product from the marketplace, including consumer homes, stopping what might have been a larger outbreak.
Third, we dispatched an investigative team, with the right expertise, to the plant to evaluate the adequacy of the plant's control measures and records and to interview plant employees and management.
Any conclusions about the recall will have to await completion of the ongoing investigations by FSIS and USDA's Office of Inspector General. In the meantime, however, the recalls have raised a series of issues that we are beginning to address, including the adequacy of our current authorities.
Earlier this month, I met with industry to discuss ways to improve ground beef plant operating practices, product coding procedures, and record keeping to keep similar problems from happening again.
Yesterday, we held a public meeting on our recall policy, including public notification procedures, to determine if changes are needed.
And USDA Secretary Dan Glickman has proposed legislation with three important provisions to facilitate the HACCP-based inspection approach. First, the legislation would enable USDA to stop the distribution and order the recall of adulterated or misbranded meat and poultry in situations that pose a reasonable probability of a threat to public health and companies are failing to respond accordingly.
Second, it would allow us to refuse or withdraw inspection based on any willful or repeated violation of Federal meat or poultry laws.
And third, it would allow the Department to impose civil monetary penalties for violations of the meat and poultry laws, particularly the new HACCP regulations.
In closing, I believe we have made significant progress, but many challenges remain. Not only must we find ways to address the current pathogens of concern, but we must be constantly vigilant for emerging ones--especially those that behave in new ways. We must have a strategy and approach that is flexible enough to respond to new risks and new ways of addressing those risks. I believe we have started down that road.
For Further Information Contact:
FSIS Food Safety Education and Communications Staff
Public Outreach and Communications
Phone: (202) 720-9352
Fax: (202) 720-9063
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