|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Remarks prepared for delivery by Dr. Catherine Woteki, Under Secretary for Food Safety, before the Ceres Forum of the Center for Food and Nutrition Policy and the American Association of Veterinary Medical Colleges, Sept. 25, 1997, Georgetown University, Washington D.C.
I'm pleased to be here with you this morning to talk about food safety, E. coli, and, specifically, about E. coli O157:H7. My remarks will focus primarily on E. coli in meat products, although the pathogen is affecting a larger spectrum of the food supply.
I can attest firsthand to the power this microorganism exerts on public health officials such as myself, as well as on the public psyche. Just two weeks after I was confirmed as Under Secretary for Food Safety, I was on national television discussing the largest recall of ground beef in USDA history because of contamination with E. coli O157:H7.
If you consult a textbook of microbiology, you would find out that E. coli is a gram-negative, rod-shaped bacteria belonging to the family Enterobacteriaceae, and that E. coli O157:H7 is a pathogenic strain that produces large quantities of two toxins that can cause severe damage to the intestinal lining and other organs. You would also probably read that it doesn't take very many organisms to make someone sick--perhaps 10 or fewer organisms could seriously harm an individual.
History Behind Pathogen Reduction
What the textbook won't tell you is how E. coli O157:H7 is responsible for changing the Nation's mind set about foodborne pathogens. Such a tiny organism, but such a large impact. Less than a decade ago, the pervasive attitude among industry--and even among some regulators--was that bacteria, including pathogens, are a natural part of the environment and can't be controlled. The idea that government would begin setting standards for pathogen reduction, and testing raw products for bacteria contamination, was beyond belief. And the idea that industry would begin to embrace HACCP as good business was a reality only among the most progressive industry leaders.
But that's exactly what happened. It didn't happen overnight. It was a gradual awakening that began with emerging scientific data about pathogens and a growing realization that the meat and poultry industries have changed. Foodborne pathogens are not new. As early as 1830, Trichinella spiralis was recognized as causing foodborne disease.
But many factors have forced us to place more emphasis on foodborne pathogens as a health risk. First, of course, is the growing knowledge about pathogens, how they are transmitted in the food chain, and their role in causing disease. New pathogens are emerging, and some of them, such as E. coli O157:H7, are quite virulent. Now, there are more opportunities for contamination to occur, with a trend toward convenience foods that are prepared in advance and a population that is not as savvy as our grandparents when it comes to food preparation. Also, there are more immune-compromised and elderly individuals in the population who are more susceptible to foodborne illness.
At the same time, a growing population and changing consumer needs have caused rapid change in the meat and poultry industries. With the trend toward industry concentration, where few firms possess a large share of the market, and nationwide distribution of products, a greater opportunity exists for the population to be exposed to foodborne pathogens. In addition, the increased use of brand names, coupled with our enhanced ability to trace illness to specific products through molecular fingerprinting and a greater reporting of foodborne illness, means that more cases of foodborne illness are detected.
For some time now, USDA has known that pathogen control was its "Achilles' heel"--its most vulnerable spot. In 1983, almost 15 years ago, USDA asked the National Academy of Sciences (NAS) to evaluate the adequacy of the scientific basis of its food safety system. The Agency knew that changes were needed. But it also knew it needed scientific backing before it could begin a public debate on those changes. At that time, E. coli O157:H7 had barely emerged, and it was not even mentioned in the resulting NAS report. But there was a growing concern that traditional postmortem inspection methods were inadequate to detect pathogens such as Salmonella and Campylobacter.
Despite the overwhelming scientific support that emerged for change that would better address pathogenic microorganisms, progress occurred very slowly. While many changes were proposed, they were either very narrowly focused or focused more on improving industry productivity than on improving food safety. Many people preferred to focus on food handling and preparation by consumers as the most sensible way to reduce foodborne illness.
That all changed in 1993. The outbreak of E. coli O157:H7, attributed to undercooked hamburgers served at a fast-food outlet, was a defining moment in the history of pathogen reduction. That outbreak sickened hundreds, was responsible for four deaths, and provided a national impetus for ground-breaking change.
Granted, this was not the first outbreak of foodborne illness in history, nor the largest. But in many ways, this pathogen was unique. It didn't take much to make someone sick, and children were particularly susceptible. In addition, the food source implicated in the outbreak--hamburgers--was a traditional, all-American meal.
That outbreak had far-reaching ramifications for everyone--industry, regulators, and consumers. Industry cries that consumers should simply cook their food well just didn't cut it anymore. Food processors began to look at what they could do to reduce contamination. With mobilized support for change, the new Administration in Washington proposed a major overhaul of an antiquated food safety system. And with four tragic deaths linked to undercooked hamburgers, consumers groups became more effectively and increasingly involved.
That brings us to today. What have we really accomplished so far in pathogen reduction, and is it enough?
I believe USDA is making significant progress in its fight against foodborne illness. Shortly after the 1993 outbreak, USDA issued a rule, after overcoming an industry legal challenge, requiring safe handling labels that address storage, cooking, and holding practices for raw meat and poultry products.
In 1994, after withstanding another legal challenge from industry, USDA established E. coli O157:H7 as an adulterant when present in raw hamburger and initiated a monitoring program for the pathogen in ground beef. We currently test over 5,000 raw ground beef samples per year from plants and retail locations.
Pathogen Reduction and HACCP Rule
In 1996, after a thorough public process, USDA published its landmark rule on Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP). That rule requires all plants that slaughter and process meat and poultry to implement HACCP systems as a means of preventing contamination from pathogens and other hazards. The preventive approach that is embodied in HACCP is an important principle in our fight against pathogens, because we all know you cannot ensure the safety of a product through testing. Prevention must be our first line of defense.
To make sure HACCP systems are working as intended, the rule also sets in-plant performance standards for Salmonella, and the Food Safety and Inspection Service (FSIS) will conduct testing to ensure these standards are being met. Indeed, this is a very significant step, because it is the first time USDA has set a performance standard for a broad range of raw meat and poultry products.
Because Salmonella, E. coli O157:H7 and other pathogens are associated with fecal contamination, the rule also requires slaughter plants to routinely test carcasses for generic E. coli, an indicator of fecal contamination. And the rule requires all plants to have in place standard operating procedures for sanitation.
Non- Regulatory Changes
USDA has implemented many non-regulatory changes as well. FSIS has undergone a reorganization to improve its ability to carry out its food safety responsibilities. One component of the reorganization was the creation of a new Office of Public Health and Science to provide a renewed and expanded focus on public health. Within that office, there exist new divisions of Epidemiology and Risk Assessment and Emerging Pathogens and Zoonotic Diseases.
Sentinel Site Study
In 1995, CDC, USDA, and FDA initiated a Sentinel Site Surveillance project, now known as FoodNet, to collect more precise information about the incidence of foodborne illness, especially illness caused by Salmonella and E. coli O157:H7. The program collects foodborne illness incidence data from seven sites around the country. First-year data from the project are already providing us with important information. For instance, they show that Campylobacter is causing the majority of sporadic illnesses associated with meat and poultry products.
Major developments in technology have also provided us with better tools to fight pathogens. USDA made a special effort to encourage innovation, and the industry deserves credit for implementing technologies such as steam pasteurization and antimicrobial carcass sprays in plants. We expect to see many more technologies surface as potential tools for pathogen reduction, including irradiation and new microbial detection methods.
We have also made progress in farm-to-table food safety. From the very beginning, we have known that an effective food safety strategy must address the entire farm-to-table chain, not just what goes on within inspected plants. Our authority outside of plants is limited, but we are making progress by working closely with other government agencies, professional groups, academia, and industry.
For instance, at the animal production level and intermediate stages before the slaughter plant, USDA is working with producer groups 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 the transportation to retail level of the farm-to-table chain, we are working with FDA to develop standards governing the safety of foods during distribution. We are placing particular emphasis on time and temperature control as a means of minimizing the growth of pathogenic microorganisms. Once such standards are in place, we are committed to providing inspection personnel to ensure that these standards are complied with.
At the retail level, we are working again with FDA, and with State officials, to ensure the adoption of science-based standards and to foster HACCP-type preventive approaches--largely through the Food Code process.
We are seeing some tangible results of this cooperative process. For instance, the American Veterinary Medical Association is spearheading changes in the veterinary school curriculum to focus more on public health. The fast-food industry is implementing HACCP, setting food safety specifications for its suppliers, and has changed cooking procedures to address food safety concerns. And we recently began a series of training sessions for state and local food inspection agencies on the potential risks associated with meat and poultry products processed at the retail level and in food service operations.
Together, these steps are significant. They correspond to what food safety experts have recommended for years--an emphasis on prevention, and a food safety system based on the true risks in the food supply.
Ground Beef Recall
I believe the recent recall of ground beef due to E. coli O157:H7 illustrates how far we have come since 1993, when the first major hamburger-based outbreak occurred.
With the most recent recall, an infrastructure for Federal-State cooperation during outbreaks was in place, which resulted in USDA finding out about the problem quickly. The health department in Colorado notified FSIS of several confirmed cases of illness caused by E. coli O157:H7, and with modern molecular fingerprinting technology, we confirmed that one of the patient isolates matched meat isolates from an opened packages of patties from the patient's freezer. These isolates also matched unopened packages at the retail level.
Second, because of our improved public health focus, we quickly removed the contaminated product from the marketplace, and quickly dispatched an investigative team to the plant to identify the source of the contamination and evaluate the adequacy of the plant's operating procedures, control measures and records.
We will never know exactly how much of a difference these initiatives really made, but the Centers for Disease Control and Prevention believes that the prompt recognition of this contamination incident, and our collective, rapid response to the incident, may have prevented a much larger outbreak of foodborne illness.
Despite our progress, we continue to face many challenges in the years to come.
A major challenge for the future is having enough, and the right type of, information on which to base regulatory decisions and develop new prevention strategies. On a very basic level, we must encourage fundamental research on the natural history of human pathogens in animals. We need to know, for example, how these pathogens develop disease-resistance and how they acquire the ability to produce toxins. This fundamental science will set the stage for potential breakthroughs in vaccines and other preventive approaches.
It's clear that scientific knowledge has not reached the point where we can say, with any certainty, what practices will reduce microbial pathogens in animals before slaughter. But we are seeing some progress. And epidemiological research to trace the problems we are having with E. coli O157:H7 and other pathogens back to their sources will be useful in our efforts to develop effective prevention strategies on the farm, in feedlots, and other intermediate stages before animals reach the slaughter plant.
We also need research to help us make regulatory decisions that are based on the most current science. HACCP provides an important framework for improving food safety within plants, but it must be combined with science-based performance standards that HACCP systems are designed to achieve. Through the HACCP rule, we have taken the first steps toward setting science-based performance standards for pathogens based on the levels of Salmonella currently found in various products. But our ultimate goal is to base performance standards on quantitative risk assessments. We need extensive, new data to conduct these risk assessments.
That is why we are extremely interested, and involved, in food safety research and development. FSIS is not a research agency. But it certainly has an important role in identifying research needs to fill critical data gaps. As Under Secretary for Food Safety, I will ensure that regulators, consumers, producers, researchers and processors work closely together to identify research priorities.
Another major area where we need to do a lot more work is in educating those involved in producing, transporting, and preparing food, including consumers. The mind set on pathogen reduction may have changed, but not everyone is on board.
For instance, we need to do a better job of changing food safety behavior in the home. It's not enough to provide information--we must be able to change behavior. In June, USDA, in cooperation with FDA and CDC, sponsored a conference here at Georgetown University as a means to share information on changing food safety behaviors. We will soon announce a new education campaign for consumers that is the result of government and industry working together.
We also need to make sure industry is on board when it comes to taking responsibility for food safety within their own operations. Mandatory HACCP and performance standards for Salmonella provide an incentive for plants that slaughter and process meat and poultry to implement process control systems, but what about the rest of the industry not subject to this regulation?
Market forces will have some influence. We are already seeing retailers place pressure on their suppliers to have HACCP systems and to test products for contamination, and we believe such market forces will lead to change at all levels of the farm-to-table chain. But we also need to rely on education as a means of encouraging those involved in producing, transporting, and preparing food to follow good manufacturing practices. I hope the veterinary community will do its part at the animal production level.
President's Food Safety Initiative
The President's Food Safety Initiative, which was announced on January 25 of this year, will help us to meet many of these challenges on a government-wide basis.
improves inspections and expands preventive safety measures;
increases research into developing tests to detect foodborne pathogens and to assess the risks of foodborne illness;
expands the FoodNet active surveillance system that I described earlier;
establishes a national education campaign to improve food handling in homes and retail outlets; and it
establishes a new, intergovernmental group to further improve Federal, State, and local responses to outbreaks of foodborne illness.
I will be working closely with the Department of Health and Human Services and the Environmental Protection Agency to see that those initiatives receive funding and are put into place. We're also working together to prepare an FY 1999 budget initiative on food safety.
I would like to close with a word of caution. This conference focuses heavily on E. coli O157:H7, but we must be careful not to lose sight of the many other foodborne pathogens that are already here and those with new disease-causing capabilities that have yet to emerge. Certainly, E. coli O157:H7 has been on center stage for the past several years, but finding a set of specific actions to address this specific pathogen is not the answer to foodborne illness.
The challenge, for regulators, industry, and academia, is to develop a comprehensive approach that addresses all known pathogens, and to be constantly vigilant to emerging ones. I believe we have made significant progress, but this certainly is no time to relax. As a case in point, outbreaks of E. coli O157:H7 are now associated with radish sprouts and lettuce--newly recognized vehicles for the transmission of the pathogen. We have a lot of work ahead of us, and we must work together in a coordinated fashion to make real progress. I look forward to working with all of you to meet our mutual goal of reducing the incidence of foodborne illness.
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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