|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 faculty and students, College of Veterinary Medicine, Michigan State University, Nov. 24, 1997, East Lansing, Michigan.
Good afternoon. It's a pleasure to be with you to discuss some of today's key food safety concerns, and the growing public health role of the veterinarian in addressing those concerns. This afternoon, I'm speaking with you from the perspective of Administrator of the Food Safety and Inspection Service (FSIS). I've also enjoyed working with the veterinary community in "previous lives" at the Food and Drug Administration and the National Marine Fisheries Service.
Many of you have heard the statistics about foodborne illness: The economic impact of foodborne illness, in terms of medical care, lost wages and associated costs, is $5.6 to $9.4 billion per year.
The human costs of foodborne illness are enormous. Annually, 6 to 33 million Americans become ill. Foodborne illness contributes to the deaths of perhaps 9,000 persons each year.
The personal impact of foodborne illness is staggering. A child who eats an undercooked hamburger--or drinks unpasteurized apple juice--may suffer Hemolytic Uremic Syndrome and failing kidneys if that unpasteurized juice or rare burger carries E. coli O157:H7. A pregnant woman who enjoys a soft cheese appetizer can lose her child if the cheese was made from unpasteurized milk that happened to carry Listeria monocytogenes. An AIDS patient may be hospitalized for weeks after a tasty chicken dinner that carried Campylobacter because the cooked chicken was taken off the grill and put back on the platter holding raw juices. A nursing home resident may become deathly ill after enjoying a Caesar salad made with raw eggs that happened to carry Salmonella enteritidis. Unfortunately, those with an incompletely developed or compromised immune system are generally most vulnerable to serious health consequences from foodborne illness.
The problem of foodborne illness is significant, it permeates the food chain, and it requires all of our efforts. That's the bad news. The good news is that we are fighting back. Your College of Veterinary Medicine and your new National Food Safety and Toxicology Center are part of that fight, and I hope that you will see yourselves as part of that fight.
Twenty years ago, the inspection service viewed its job largely in terms of ensuring clean meat and poultry from healthy animals. The role of the veterinarian in that mission was clear and direct. A veterinary practitioner in the community helped animal producers protect their animals from diseases that may not even be in tomorrow's textbooks. A veterinary medical officer in the inspection service supervised the removal of diseased carcasses or parts of carcasses from the human food supply. A veterinary researcher in government or industry worked to find causes and cures for those diseases.
Of course, the picture wasn't quite so simple. Chemical residues were--and remain--a concern. Antibiotics help ensure healthy animals, but we don't want to eat them as a side dish.
The veterinary medical community has tirelessly fought the problem of illegal chemical residues, institutionally and individually. Individual veterinarians in the community have explained, over and over and over again, why animal producers needed to honor FDA drug withdrawal times before sending animals to slaughter. VMO's in USDA's inspection service have watched for, and reminded inspectors how to look for, the injection marks or other subtle signs of veterinary drug abuse. Veterinarians are among those at FDA's Center for Veterinary Medicine who have pursued the court cases which have shown that deliberate misuse of animal drugs will not be tolerated. And, veterinary professional organizations have been in the forefront of successful cooperative efforts such as the Residue Avoidance Program.
From time to time, we are reminded that the problem of chemical residues in food has not gone away, that it permeates the food chain, and it requires all of our efforts. This past summer, ball clay contaminated with dioxin found its way from a clay mine into animal feed and then into fish, poultry and other food. To date, the Environmental Protection Agency has not untangled the mystery of how the dioxin came to be in the clay, and we may never know. While the levels of dioxins detected in food did not pose any acute health risk, the government food safety agencies agreed we had to respond to the problem based on what we don't know, as well as what we know, about the cumulative, long-term health effects of exposure to chemical residues from many sources, including food. That is going to be an active research area for many years to come.
Now, however, I'd like to bring your focus back to foodborne illness. The problem is significant, it permeates the food chain, and it requires all of our efforts. We have made significant progress, and we have a long fight ahead. The veterinary community has played an immeasurably valuable role in overcoming animal disease and maintaining defenses against illegal chemical residues. Now, you are needed in the fight against foodborne illness.
Over the past few years, FSIS has worked diligently to reform the food safety program for meat and poultry so that it better protects the public from foodborne illness. We reached a milestone in our strategy for change in July 1996 with publication of our final rule on Pathogen Reduction and HACCP. The new rule modernizes a 90-year-old inspection program and fulfills the Clinton administration's commitment to improving food safety. And it responds to longstanding calls for change from the National Academy of Sciences and experts throughout government, industry, and the scientific community.
By January 1998, approximately 300 meat and poultry plants--the largest in the country--will be required to have developed and implemented a HACCP program with science-based controls to prevent and reduce food safety hazards. Both slaughter and processing plants need to have the systems in place. Small plants will have until January 1999 to implement the programs, and the very smallest operators will have until January 2000. We are encouraging the industry to implement HACCP programs before they become mandatory.
HACCP is conceptually a simple system whereby meat and poultry establishments can identify and evaluate the food safety hazards that may 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. HACCP is the best system currently available for maximizing the safety of the nation's food supply.
The Pathogen Reduction and HACCP rule provides many benefits. First, it establishes the conceptual and regulatory framework for improving food safety in meat and poultry establishments--a framework that allows for changes as science and technology improve. The new system also emphasizes the prevention of food safety problems rather than heavy reliance on government inspectors and veterinarians to detect and correct problems after they occur. In addition, the rule makes it clear that the industry is responsible for producing and marketing products that are safe, unadulterated, and properly packaged and labeled. Government's role is to verify that statutory requirements are being met and for taking appropriate compliance and enforcement actions when the requirements are not met.
A cornerstone of safe food preparation is, of course, a sanitary environment. Since January 1997, all meat and poultry plants have been required to develop and maintain written Standard Operating Procedures for sanitation to reduce the likelihood that harmful bacteria will contaminate the finished product. The Sanitation SOPs must describe all procedures the plant conducts daily to prevent direct contamination of products. The Sanitation SOP's are the first national performance standards for sanitation in meat and poultry plants. Follow-up reviews indicate the SSOP's are effective, but in about 14 instances we've had to move into an enforcement mode to stimulate companies to correct their sanitation systems. That's 14 instances in a nationwide network of about 6,500 federally inspected plants and more than 2,500 state-inspected plants.
To verify that HACCP systems are effective in reducing contamination with pathogenic microorganisms, FSIS has set pathogen reduction performance standards for Salmonella that slaughter plants and plants that produce raw, ground meat and poultry must meet. Except for the zero tolerance for E. coli 0157:H7 in raw ground beef, which has been in effect for several years, these are the first performance standards for pathogens on raw meat and poultry. In addition to meeting performance standards for Salmonella, since January 1997, all slaughter plants have been required to conduct microbial testing for generic E. coli to verify that their process control systems are working as intended to prevent fecal contamination, which as you know is the primary avenue of contamination for pathogenic microorganisms.
The final rule set an important framework for change in FSIS. Now, we have almost nearly completed a major reorganization that is helping us carry out our regulatory responsibilities in a more scientific and efficient manner.
Our new Office of Public Health and Science infuses a public health focus into all FSIS work, whether it is overseeing product recalls or helping to guide the "sentinel site" epidemiology project. The Office of Policy, Program Development and Evaluation centralizes all policy making functions in the Agency, will develop the inspection procedures of the future, and evaluate all of our changes to ensure their effectiveness. And, we have streamlined the management structures both at headquarters and in the field, and consolidated the three formerly independent field structures into one. Some of the pressure for streamlining was imposed from above; however, we have responded to that call by reorganizing in a way that redeploys our resources to fulfill our evolving food safety mission.
In 1994, Congress transferred the responsibility for animal production food safety from USDA's Animal and Plant Health Inspection Service to FSIS. As a result, we established at FSIS an Animal Production Food Safety Staff. The transfer of this responsibility to FSIS does not mean we believe FSIS should assume a direct regulatory relationship with animal producers. Rather, we see ourselves working with the animal production community to identify problems and guide research and other activities toward the greatest public health risks. These are just a few of recent organizational changes reflecting more precision in the focus of our mission.
Earlier, I mentioned case studies of foodborne illness. Those illnesses were caused by the four pathogens of most public health concern today: E. coli O157:H7, Listeria monocytogenes, Campylobacter and Salmonella.
Although Salmonella and Campylobacter jejuni have been recognized pathogens for many years, they have assumed new public health importance in recent years. Listeria monocytogenes, not even known to cause foodborne disease until the early 1980's, shot into the headlines in 1985. An outbreak that caused many spontaneous abortions in pregnant women in the Hispanic community of Los Angeles helped galvanize the food safety agencies and the food industry to re-examine traditional food processing techniques and environments. The outbreak of hemorrhagic E. coli in the western states just a few years ago led USDA to declare E. coli O157:H7 an adulterant in raw ground beef, to require safe handling or care labels on raw meat and poultry products, and catalyzed HACCP rulemaking and implementation.
Today, we hope and believe we are past the point where we must have huge outbreaks and headlines to effect continued improvement in our food safety systems. In fact, the food safety agencies are speaking with one voice and working together for the same objectives. This "common sense" government approach requires careful coordination at the everyday working level as well as the highest levels of government.
In May 1997, the food safety agencies, including the Centers for Disease Control and Prevention, presented a report to the President--his Food Safety Initiative for Fiscal Year 1998. In that report, we explained why we are most concerned about those four pathogens, what we are doing now to combat them in a farm-to-table framework, and what we need to do in the future.
That report--which is accessible on the Agency's website (http://www.usda.gov/fsis)--built on the interagency food safety research agenda for the future--also accessible on our website. It identifies the food safety "data gaps" in the research continuum from farm to table.
The data gaps belong to all of us, including industry and academia, must work together to fill them. As regulators, we have an obligation to the public to design the best regulatory programs we can based on the data and knowledge available and to seek additional data and information as we identify the need for it. To reach the ultimate goal of establishing pathogen-specific performance standards, and to enable the industry to produce food products that meet such standards, a balanced research agenda that addresses public health issues, methodologies and diagnostics, basic science, and intervention strategies, is needed.
We are particularly interested in data that is needed to carry out quantitative risk assessments because risk assessment is one of the most powerful tools we have to identify specific hazards and potential controls. Primarily, FSIS needs to establish the linkages between pathogens present on or in animals and consequent human disease so that it can effectively identify interventions. Right now, we don't really know the relationship between the numbers of bacteria on raw product and foodborne illness. Nor do we know whether the numbers of illness vary according to factors such as age, immune status, and socioeconomic status.
FSIS also needs research to provide better tools to generate those data. One example is the need for much simpler and rapid ways to isolate and identify Campylobacter. Most of the funding the agencies requested in our Fiscal 1998 budgets to implement the components of the initiative was approved by Congress.
Within the farm-to-table continuum, one of our specific interests at FSIS is in learning more about compounds, technology and animal production practices that can reduce the levels of pathogens in and on animals coming to slaughter. We recognize that we have come much farther in developing preventive programs for animal production residue control than we have for the control of microbial pathogens.
Scientific information does not exist at this time to show what is effective and economically feasible at production stages to reliably eliminate pathogens on carcasses. Some progress is being made, however, in defining methods that reduce pathogen levels in animals entering slaughter establishments. For instance, researchers have reduced Salmonella in poultry by feeding competitive exclusion products, controlling rodents, and buying feed and chicks from suppliers on certified Salmonella reduction programs. Research on E. coli O157:H7 may confirm that water troughs are reservoirs for the organism.
But we must go farther, and veterinarians will play a prominent role in helping to develop science-based systems to prevent microbial hazards in animal products. This is one of the arenas in which the veterinary researcher, practitioner and the entire veterinary community will have an increasingly important role. It is a difficult, challenging, exciting and incredibly important arena. It depends on both the ability to address veterinary research questions in terms of human rather than animal health, and then to apply that information in the practical setting of animal production practices.
The research community has begun to shift more of its efforts to the on-farm sector, and we will encourage that direction, a trend started by Dr. King during his tenure as Administrator of APHIS. The lead responsibility for USDA food safety research falls to the Agricultural Research Service. The Cooperative States Research and Extension Service oversees cooperative external research. This means that FSIS does not conduct research, as such, but relies on and influences the USDA research network.
While our attention to food safety goes beyond the plant, that does not mean we believe we have finished the job within plants. With implementation of the final rule on Pathogen Reduction and HACCP, we believe there are additional opportunities to improve the way we carry out inspection activities both to improve food safety and to improve the allocation of our resources. We have known for some time, for instance, that there are activities we carry out within plants as part of the current inspection process that have limited value in terms of public health protection or meeting other consumer protection responsibilities. We also know that there are important public health tasks we do not carry out under the current system of inspection. We have recently selected three pilot plants in which we plan to explore new ways of conducting inspection, followed by a public process to obtain input from all stakeholders.
We believe that by redesigning the inspection process within plants, we can redeploy some of our current inspection workforce to the product transportation and storage areas that would benefit from more regulatory oversight. Also, there are new HACCP verification tasks in both slaughter and processing plants that our inspectors must perform. With a finite workforce and a Federal budget process highly focused on balancing the budget, redeployment may be our only option.
These major initiatives provide many opportunities for veterinarians. Within the Agency, our veterinary medical officers are playing a significant role--along with other inspection personnel--in implementing the new system of inspection. Under that system, regulated establishments are responsible for manufacturing products that meet Agency requirements. The regulator's role is to verify that requirements have been met and to take action when there is sufficient evidence that requirements have not been met. Thus, the new rule more clearly defines and separates the role of the food producer and the regulator. This is a culture change that is essential to the success of the new system and is beneficial to our inspection workforce in that it allows our employees to do the job they were educated and trained to do.
These changes mean that our inspection force must be ready to adapt to the new food safety paradigm. They must be able to manage both programs and people in the context of this cultural change. They must be familiar with emerging risks in animals and in the meat and poultry supply and how they can be prevented or controlled in the plant environment. And they must be ready to conduct situation-specific risk assessments and guide establishments in ensuring that their HACCP systems accurately addresses the specific risks that exist in a particular plant. Our veterinarians will have to have the expertise to meet these needs.
We are also changing our organizational culture in a very deliberative manner. We are placing more emphasis on continuing education and a "lifelong learning" approach to education, providing more opportunities for our employees, veterinary or otherwise.
But we are also making it clear that we expect employees to exercise initiative in order to progress in this organization, USDA or government in general. For example, veterinarians with public health degrees or intensive epidemiology training are better equipped to move into management in a public health agency such as ours.
We are also in the process of refining the "management competencies" we expect of our managers and leaders, and of establishing the "school without walls" management and leadership academy framework within which employees can build their futures.
A special program for food inspectors began about a year ago at Texas A&M, under which inspectors will focus on such subject areas as microbiology, risk assessment, environmental sanitation, and statistics. The program is intended to be educational, geared towards explaining and giving an understanding of why food safety problems occur, rather than simply a training program that merely shows how to carry out inspection tasks. We are offering a similar opportunity to veterinarians to enroll in continuing education courses through colleges, universities, and training organizations to supplement their education in a variety of important areas such as risk assessment and epidemiology.
These continuing education opportunities will help to bridge the gap between what our inspection personnel had to know under the previous system and what they have to know now. As a major employer of veterinarians in the United States, we would like to see this knowledge imparted to veterinarians at an earlier stage--during their veterinary education. Veterinary schools have begun to provide effective training not only in new scientific areas related to public health but also in the management of programs and people. We are happy to see this trend. The new FSIS will be undergoing constant change, and we need a workforce that knows how to manage such change.
As you can see, we have a lot of work ahead, and it will take all of us working together to get the job done. I hope some of you are considering careers in public health and will help us to meet our food safety goals. I believe veterinarians have an important role in our Agency's future, and I look forward to seeing you involved.
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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