|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, U.S. Department of Agriculture, before the Transport and General Workers Union (T&G), September 3, 1997, London, England.
Good morning. It's a pleasure to participate in this conference on food safety. You have a very diverse audience assembled here today, and I commend you on taking the initiative to debate important food safety issues in such an open forum. It is a strategy we have benefitted from extensively during the last several years.
I am here today to discuss the U.S. food safety experience. In many ways, the experiences we have had with food safety in the United States parallel the experiences of the United Kingdom and many other countries. Emerging pathogens, such as E. coli O157:H7, have caused outbreaks in many countries, including ours. Other hazards--such as bovine spongiform encephalopathy (BSE)--have not impacted us directly--that is, we are BSE-free.
Nonetheless, what these experiences have in common is that they have forced all of us to re-examine our fundamental approach to food safety. Such self-examination can be difficult, but we must make sure we are doing everything that can be done to protect the public health. That is, we must minimize foodborne illness to the extent that science and technology permit.
The United States faced a significant food safety crisis several years ago. Following an outbreak of E. coli O157:H7 in several western states in 1993 that was attributed to undercooked hamburgers, the public demanded a safer meat and poultry supply. The Food Safety and Inspection Service (FSIS) began an intensive and comprehensive overhaul of its food safety program. It is now a work in progress.
Because the Agency's authority for regulating food safety is restricted to meat, poultry, and egg products, the U.S. Food and Drug Administration (FDA) is initiating similar food safety improvements for other foods such as seafood and produce. The two agencies have worked closely together on numerous food safety initiatives to ensure that public confidence in the safety of all foods remains high, and I will discuss many of these in further detail today.
The need for change in the traditional meat and poultry inspection program was apparent long ago, but the outbreak of E. coli O157:H7 in 1993 provided a national impetus for significant change and mobilized government, industry, and consumer resources toward a common goal. Fortunately, studies conducted over the past decade by the National Academy of Sciences, the U.S. General Accounting Office, and FSIS itself provided the scientific and policy basis for the changes we knew had to be made.
When we began to develop our food safety strategy, we recognized that it was not enough to make a few select changes, and leave it at that. That had been done in the past, and those changes had not reached the root of the problem. We needed a comprehensive strategy that would address all of the weaknesses in the traditional inspection system for meat and poultry.
Such changes could not be made overnight. Certainly, it would require continuous efforts to improve how hazards are identified and prevented. And we knew that what works today may not work tomorrow. Continued vigilance would be necessary to ensure the integrity of our program.
As we began this process of reinvention, we developed some principles to guide us.
For instance, we knew we had to target the most significant risks in the food supply, even though they represented the biggest challenges. A major weakness in the traditional inspection system was its inability to deal directly with pathogenic microorganisms, particularly on raw products. The time had come to require plants to prevent or control contamination through process control and science-based, anti-microbial technologies, rather than 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. Performance standards for pathogenic organisms, used in conjunction with preventative process control systems, we believe, are the most powerful and effective tools available for bringing about change.
We also knew that our strategy had to clarify the respective roles of industry and government in ensuring the safety of meat and poultry products. Companies producing meat and poultry products are responsible for ensuring that their products are safe. Government is responsible for verifying that its requirements have been met and for taking appropriate remedial actions when the requirements have not been met.
This is a very important concept, because, by placing responsibility for the production of safe products on the industry, government is better able to use its limited resources more efficiently and effectively. While this concept makes perfect sense, we knew that clarifying the respective roles of government and industry would require a massive culture change on both sides. It also required an extensive dialogue with our consumers, because they expect and demand an effective, independent government regulatory system, including inspections.
We also knew that even though the majority of our regulatory authority lies within federally inspected plants, our food safety strategy had to address the entire farm-to-table, or plough-to-plate, chain. Hazards that can result in foodborne illness arise at each stage in the farm-to-table continuum. Each stage presents hazards, and each provides opportunities for minimizing the effect of those hazards. Thus, our strategy incorporates the concept of multiple hurdles, along the farm-to-table continuum.
We knew that under any new food safety system, industry must have the flexibility, and the incentive, to innovate to improve food safety. We could provide this flexibility in two ways. First, by adopting a regulatory strategy that stimulated innovation by establishing targets for pathogen reduction. And second, by ensuring that our requirements and procedures did not in any way stifle innovation. We must be open to new technology that can make food safer.
We also knew that achieving our food safety goals would require substantial change within the Agency itself. We had to be sure we were appropriately organized, that our resources were appropriately allocated, and that the work our inspectors did was consistent with the new regulatory framework.
And we saw the need to reform our existing regulations, including the elimination of many, to be consistent with HACCP principles. Traditional regulatory requirements have been very detailed and prescriptive, specifying, for example, precise, step-wise cooking time-and-temperature combinations for many products. We needed to convert our command-and-control regulations to performance standards to allow industry the flexibility to innovate.
The result of our planning, and the public rulemaking process that followed, including extensive dialogue with all stakeholders, was a regulatory strategy that encompassed major changes in how plants operate, as well as major changes in how we operate as a regulatory Agency. The progress we have made since then has been significant, I believe, by anyone's measuring stick.
On July 25, 1996, we published our final rule on Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP), which sets new requirements for the slaughter and processing plants we regulate. The rule is significant in that it mandates HACCP, establishes food safety performance standards with respect to pathogenic microorganisms in raw products, and it clarifies that industry must assume more responsibility for producing safe food.
We are now implementing the final rule in plants nationwide. In January 1997, all slaughter plants were required to begin testing for generic E. coli to determine if their processes are under control with respect to the control of fecal contamination. We also began requiring all plants to have standard operating procedures for sanitation. Implementation of these two provisions of the final rule is running very smoothly.
In January 1998, implementation of HACCP begins. Implementation is being phased in, with the largest plants required to have HACCP plans up and running first. By January 2000, all plants will be required to have HACCP in place. In conjunction with HACCP, all slaughter plants and plants that produce ground products have to meet specific Salmonella performance standards.
We have also made progress in farm-to-table food safety. At the animal production level and intermediate stages before the slaughter plant, we are working with industry, academia, and other government agencies to develop and foster measures that can be taken on the farm and through distribution and marketing of animals 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, will be useful in establishing risk reduction practices on the farm and during intermediate marketing stages.
We are also working with FDA to develop joint standards governing the safety of foods during transportation and storage, with particular emphasis on the importance of time/temperature control in minimizing the growth of pathogenic microorganisms.
In the retail area, FSIS and FDA are working with State and local officials to ensure the adoption of uniform, science-based standards and to foster the adoption of HACCP-type preventive approaches. They have primary responsibility for food safety oversight of retail stores and restaurants, of which there are one million in the United States. We are fostering the development of sound food safety performance standards and practices nationwide for the retail level.
While we are taking concrete steps to set standards and encourage research that addresses food safety at points outside the slaughter and processing plants, we believe that market forces, on their own, will play a major role in improving food safety along the farm-to-table continuum. Our new requirements for mandatory HACCP, performance standards, and microbial testing have no direct effect on producers, transporters and retailers, but we believe that adoption of HACCP and food safety standards within plants will have a ripple effect. As plants are required to meet the various measures of performance we have set, we believe they will apply pressure on their suppliers to implement HACCP-type systems. And transporters and retailers at the other end are feeling the pressure to implement controls to keep food safe once it leaves the plant, as well as to establish their own product specifications and testing requirements for improved food safety.
Another example of the progress we have made is the FoodNet program. We are working with Federal and local government agencies on an active surveillance system to provide us with timely, new information on the incidence of sporadic and epidemic disease due to the major foodborne pathogens.
With more accurate information on the incidence of foodborne illness, including the cause, we can better determine whether changes we make are working as intended to reduce foodborne illness. We can also more quickly identify emerging public health problems, to prevent further illness. This can then trigger appropriate, tighter process controls during slaughter and processing.
We also are in the middle of a massive regulatory reform initiative. We are shifting our prescriptive, command-and-control regulations to performance standards. We are eliminating regulations that are redundant or obsolete and simplifying those remaining to make them easier to use. We are removing certain prior approval requirements, such as those for equipment and facilities. These initiatives will reduce unnecessary regulatory burden on the industry while providing plants with the flexibility to meet our food safety standards in a way that makes sense for them.
We have just about completed a major reorganization that prepares the Agency to operate in a HACCP environment. The reorganization streamlines management structures to maximize the resources available for frontline food safety activities and to establish the shortest reporting line possible between those who make policy at headquarters and those who carry it out in the field. It unifies four separate field structures into one structure to carry out all domestic and international inspection and compliance activities. The reorganization also creates a new Office of Public Health and Science, which is providing new scientific focus, leadership, and expertise. Another new office--the Office of Policy, Program Development, and Evaluation--centralizes the management of all policy, rulemaking, and program development activities to better lead and evaluate program changes.
Despite this progress, we have some unfinished business.
One important goal for the future is to continue progress on risk assessment. If we are to focus on the true risks in the food supply, we must know what those risks are. We can use risk assessment is many ways.
First, we can better target our resources if we know what are the hazards associated with certain foods and the risk to the public health 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 hazards 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 quickly 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 products. 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 stricter standards for Salmonella and additional standards for other pathogens.
Another priority for the future is to explore new models for in-plant slaughter inspection now that HACCP is being implemented. We cannot continue to inspect animals the same way now that HACCP is here. Despite our progress in many areas, we still carry out resource-intensive inspection on slaughter lines, following detailed command-and-control regulations. This will keep us from carrying out other tasks that could have a substantial effect on food safety, unless we make changes in this area.
While we need to assure consumers the same level of protection that the current in-plant slaughter inspection program provides, we need to free some resources to conduct new oversight functions under the HACCP rule and to carry out new food safety tasks during the distribution and marketing of meat and poultry products, once they leave the plant.
Let me emphasize that under any new model of slaughter inspection, the public is demanding a continuing strong government presence to verify that all of the requirements related to food safety and other consumer protections are met. This project is not about whether a government presence is needed, but about the nature of that presence. Any changes must be vetted with the public to maintain confidence that we are carrying out our regulatory responsibility. Any new system must maintain and strengthen that confidence. Continuing strong government presence is important not only domestically but internationally. Consumers worldwide must have confidence that the products they eat are produced under a domestic or foreign system with integrity. A strong government presence assures that integrity.
Throughout the development and implementation of our comprehensive food safety strategy, public participation has been a primary emphasis. We have held countless public meetings over the past several years on every aspect of our food safety strategy, and we have been pleased with the quality of discussions that have emerged from these meetings.
Public participation is extremely important in allowing us to achieve our food safety goal, which is to minimize foodborne illness consistent with available science and technology. Public policy that is made without the input of all interested parties is doomed to fail. This does not mean that everyone gets what he or she wants. Regulatory agencies must make the ultimate policy decisions. But 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 closing, there remains much to be accomplished. However, I believe the most recent problem we experienced with E. coli O157:H7 illustrates how far we have come. For those of you not familiar with the situation, millions of pounds of ground beef had to be recalled in August because of possible contamination with E. coli O157:H7.
But what is different now than during the 1993 outbreak of E. coli O157:H7?
First, we found the problem quickly because of our new FoodNet active surveillance approach. The health department in the state of 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 isolate matched the meat isolates.
Second, we quickly removed the contaminated product from the marketplace, including consumer homes, stopping what could have been a large outbreak dead in its tracks.
Third, we were well prepared to dispatch an investigative team, with the right expertise, to the plant. The team is working to identify the source of the contamination and evaluate the adequacy of the plant's control measures and records.
Finally, we will be holding meetings with industry to encourage modified processing procedures and early implementation of HACCP, prior to the regulatory deadlines.
It would be better not to have any outbreaks at all, of course, but they are going to happen. With the progress we have made, and plans underway for further improvements, we are well-prepared to respond to these emerging threats to the public health. And I believe the public has confidence in our strategy and our commitment to improvement.
For Further Information Contact:
FSIS Food Safety Education and Communications Staff
Public Outreach and Communications
Phone: (202) 720-9352
Fax: (202) 720-9063
1997 Speeches | Current Speeches | FSIS Home Page | USDA Home Page