|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Office of the Under Secretary for
U.S. Department of Agriculture
Remarks prepared for delivery by Dr. Catherine E. Woteki, Under Secretary for Food Safety, March 3, 1999, Amherst, Massachusetts, on the occasion of being named the 1999 University of Massachusetts Food Science Endresen Lecturer.
Good afternoon. It's a pleasure to be here today to present this year's Endresen Lecture. I am honored to follow a group of very distinguished individuals who have presented this lecture in past years, and I want to thank Dr. Fergus Clydesdale for extending the invitation.
It's always a pleasure for me to visit various colleges and universities around the country, because today's students are tomorrow's leaders in science and technology, business, academia, and government. In another few years, as food scientists, you could be faced with policy decisions similar to the ones that face me now as Under Secretary for Food Safety. How do we design food safety systems to protect the growing numbers of people who are more susceptible to foodborne illness? How do we encourage industry and government to invest in new research and technology that can improve the food safety? These are the types of questions that face food safety policy makers today and will face policy makers in decades to come.
I would like to use my time today to address two themes that relate to adversity.
First, I want to discuss how policy makers can use unfortunate circumstances--such as food safety crises--to make improvements in the systems that exist to protect the public health. Progress is usually incremental, but it is progress nevertheless. On rare occasions, progress is made in great leaps.
Second, because most of you are students and will soon enter the real world, as we like to call it, I would like to illustrate, through example, that no matter what career path you choose, you have ethical responsibilities, when faced with adversity, to choose the moral course of action.
I believe these lessons are valuable regardless of what profession you choose. The ability to respond appropriately to adversity, both from a policy perspective and a moral perspective, is something we all need to know, and should know, how to do.
To illustrate the timelessness of this message, I would like to take advantage of the renewed interest in Shakespeare, evidenced most recently by the hit movie Shakespeare in Love. U.S. News and World Report recently described Shakespeare as a powerful force in American culture, not only in classrooms, theaters and books, but also in the busy precincts of commerce, politics, and everyday life. Americans, the magazine continued, have become more keenly appreciative of Shakespeares power to describe the human predicament.
So I will borrow some of the Bards rhetoric from As You Like It, a story of how a bad situationbanishment to the wild forestturns into good as the exiles become accustomed to their surroundings. The characters overcome adversity so that they are in a better place than where they began. Early in the play, the banished Duke says:
Sweet are the uses of adversity,
Which, like the toad, ugly and venomous,
Wears yet a precious jewel in his head;
And this our life, exempt from public haunt,
Finds tongues in trees, books in the running brooks,
Sermons in stones, and good in everything.
For those of you not familiar with the reference to the toads "precious jewel in his head," in Elizabethan times, the jewel was believed to be an antidote to the toads poison.
I would like to now bring Shakespeare to modern times, and use three examples of situations we have encountered related to food safety, where government and industry used adversity to make progress in improving the safety of the food supply.
A recent article in the New York Times magazine, discussing the role of governors versus the President, noted that governors have few opportunities to be visionaries. Instead, their jobs consist largely of crisis management, political accommodation, and governmental reform. That, too, describes to a large extent the job of Under Secretary. But the first example I will present is an example of a rare opportunity where a visionary, in the right place at the right time, can seize an opportunity to make major transformations.
I am referring to an outbreak of foodborne illness that occurred 6 years ago attributed to E. coli O157:H7 in ground beef patties prepared in a fast food restaurant. In a speech to Georgetown University several years back, I referred to E. coli O157:H7 as an agent for change. I described how the pathogen was responsible for changing the Nations mindset about foodborne pathogens. The pervasive attitude at the time among the meat and poultry industryand even some regulatorswas that bacteria, including pathogens, are a natural part of the environment and cant be controlled. That attitude changed to one that supported significant steps by government and industry to reduce pathogens on raw meat and poultry products.
I want to give credit here to Mike Taylor, the former and first Under Secretary for Food Safety, and Tom Billy, the current Administrator for the Food Safety and Inspection Service, for the major food safety initiatives that can be traced back to the outbreak.
In 1994, after overcoming an industry legal challenge, USDA issued a rule 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 are now addressing the question of whether this designation should be extended to other raw products.
In 1996, after a thorough public process, USDA published its landmark rule on Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP) Systems. The rule requires all plants to implement HACCP as a means of preventing contamination from pathogens and other hazards, and it sets the first-ever pathogen reduction performance standards. We are now in the second phase of implementation, and by next January, all plants will have implemented these requirements.
There is no doubt that we are in a better place with regard to E. coli O157:H7 than before the outbreak. Taken together, the changes that Mike Taylor and Tom Billy achieved represent one of those rare, great leaps forward in public health policy.
This does not mean our problems are solvedfar from it. But it means that a wide-reaching strategy encompassing policy, regulation, training, and cultural change in industry and government, is in place to address this pathogen. As a result, we are better able to meet future challenges.
The second opportunity for change was an outbreak of foodborne illness in 1997again linked to E. coli O157:H7that led to the largest recall in FSIS historysome 25 million pounds of product. This situation began when I had been on the job for less than a weektalk about sink or swim.
Fortunately, because of the progress we had made since 1993, we were better prepared to respond.
First, the FoodNet active surveillance network for foodborne disease, which began in 1995 as a collaborative project of the Centers for Disease Control and Prevention (CDC), USDA, and the Food and Drug Administration (FDA), alerted us to the problem. CDC quickly notified of FSIS of several confirmed cases of illness caused by E. coli O157:H7. Also in 1995, PulseNet was borna computer information system linking Federal and State agencies that has created a growing database of molecular fingerprints of pathogens. The ability of Federal and State laboratories to do molecular subtyping of pathogens isolated from both humans and foods is extremely important. It helps public health agencies to link specific products to specific human illnesses. And it helps to link sporadic cases to a common sourcethus identifying an outbreak that might previously have been missed. This technology was recently used to identify an outbreak of foodborne illness attributed to Listeria monocytogenes in ready-to-eat products, which I will mention in just a few moments.
With PulseNet, we were able to confirm that a patient isolate matched a meat isolate from unopened packages of product from the marketplace, thus identifying the source of the outbreak as hamburger produced by Hudson Foods. We believe that this new technology was responsible for limiting the extent of the outbreak. And as a result of this experience, USDA developed new guidelines for the industry on safer ground beef production and conducted a review of its recall policies, which is still ongoing.
This example of an adverse situation also illustrates issues of corporate responsibility as well, because FSIS and the Inspector General of USDA had much difficulty in getting production records from the company. In fact, the recall expanded in size several times as we learned more about the companys practices.
It turns out that the company was carrying out the potentially hazardous practice of recycling the previous day's production into the next day's production. Damaged patties, or excess ground beef that had not been formed into patties, was held over and used the next day. This practice, called "reworking," is a common practice in the food industry. But plants must have tight control over reworked products that limits the potential for contamination with microorganisms. In this case, the plant operated without a clean break for sanitation, so there was no control over lots. Rework is not against the law or prohibited by our regulations, but here is where some lessons in corporate responsibility lie. Just because its not against the law or regulations doesnt mean its a good idea, from a public health standpoint or from a business liability standpoint. And when faced with a public health decision involving a product, complete disclosure is the best policy. Two officials of the company, Hudson Foods, were recently indicted for conspiracy and providing false information to USDA.
The third example of an adverse situation being used as an opportunity for changes involves another pathogenListeria monocytogenes.
Up until very recently, Listeria monocytogenes was considered a "success" story. In the late 1980s Listeria emerged as a problem in deli meats and other processed products, and FSIS and the Food and Drug Administration worked with plants to improve their procedures and established a "zero" tolerance for the pathogen in ready-to-eat products. As a result of government and industry actions, between 1989 and 1993, the rate of illness from Listeria dropped 44 percent.
Improvements in surveillance and outbreak investigation reflected by the FoodNet and PulseNet systems were particular evident during a recent outbreak we experienced with Listeria. In the fall of 1998, CDC noticed an increase in the number of cases of illness attributable to a specific subtype of the pathogen. After investigation by CDC and FSIS, epidemiological evidence linked the illnesses to products produced by a Michigan processing plant. While at this point, neither CDC nor FSIS had yet found the pathogen in an intact package produced by the plant, the company decided on the weight of the epidemiological evidence to voluntarily recall a number of products. Subsequently, CDC and FSIS investigators, through molecular subtyping, identified the outbreak subtype in product produced by the plant. Because the companys recall announcement got very little attention from the media, they placed ads in newspapers to alert consumers about the recall.
Thus, the good news is that our scientific capabilities are improving rapidly. The bad news is that they are sometimes outstripping our regulatory capabilities. The outbreak investigation was a success for the new PulseNet system, but it took several months to identify cases and a common source. From the regulatory perspective, we are playing "catch-up" in terms of our ability to determine what regulatory actions are needed to address the larger Listeria contamination problem. A number of questions face us. Why are protocols within plants failing, even in those with HACCP systems? Is the organism changing? Are cooking procedures adequate? Has the shelf life of hot dogs and deli meats been extended too far? Is the medical community counseling vulnerable subpopulations about Listeria and the foods in which it is found? We are now addressing these questions and will, very shortly, have a multi-faceted action plan to address this public health problem.
Campylobacter is another example of where new scientific capabilities are outstripping our regulatory capabilities. We now know from the FoodNet surveillance network that Campylobacter is the number one cause of sporadic cases of foodborne illness. It is a very important problem from a food safety standpoint, but it is a problem for which we have a very limited understanding. It also has been disheartening to learn that the reduction in Salmonella we have seen in conjunction with HACCP is not associated with a parallel reduction in Campylobacter. This phenomenon is something we need to learn more about.
A major problem is that we lack a rapid, cost-effective test for the pathogen. We have asked for help from USDA Agricultural Research Service, which carries out food safety research at our request, in developing a better test. Meanwhile, we are carrying out a nationwide baseline study to determine the prevalence of Campylobacter in raw products as an initial step toward establishing a performance standard for the pathogen.
I mentioned corporate responsibility briefly, and I want to return to this issue. Our food safety strategy is predicated on the assumption that industry has the primary responsibility to produce safe food. Government has a role, too, of course. Our role is to set food safety requirements and ensure that industry meets those requirements through oversight and verification. But we cannot inspect safety into foodthe industry must have systems in place to ensure the production of safe food.
Federal food and drug lawsspecifically, the Meat Inspection Act, Poultry Products Inspection Act, and the Food, Drug, and Cosmetic (FD&C) Act, are what are commonly termed "strict liability" statutes. This means that the laws carry a special burden of accountability for firms dealing with food and for the ethical conduct of people from the packing room to the boardroom.
In fact, on two occasions, the Supreme Court of the United States has expounded on the reasons for the special obligations of corporate leaders presented by the food and drug laws. In 1943, Justice Frankfurter wrote of the FD&C Act that the legislation "touches phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection." Similarly, in 1975, Chief Justice Burger, this time talking about the responsibility of the president of a large food chain, wrote about a "positive duty to seek out and remedy violations when they occur" and "a duty to implement measures that will insure that violations will not occur." These principles, we believe, must be at the heart of the corporate ethics program of every food production, storage, and distribution company, and must be practiced by all those who influence and control food businesses.
There are many examples of corporate responsibility, and irresponsibility in the food industry. Hudson Foods is an example of a business that did not have adequate systems in place to prevent food safety problems, and it is no longer in business. But there are many examples of industry rising to the challenge and being very proactive.
The fast-food industry is a good example. The 1993 outbreak of E. coli O157:H7 was attributed solely to hamburgers produced at a fast-food chain. The fast food industry responded quickly and forcefully by instituting new cooking requirements, conducting testing for pathogens, and setting food safety requirements for its suppliers of ground beef.
As a result, a recent case-control study of sporadic E. coli infections in 5 states found that fast-food restaurants are not a major source of infections. This does not mean the problem is solved, because infections are still connected to hamburgers prepared at home and in restaurants that are not classified as fast-food establishments. But it is a good example of how corporate responsibility can lead to good public health outcomes as well as good business outcomes.
Other industry members are following suit. We have seen a lot of interest among animal producers in doing their part. The National Pork Producers Council, for example, is implementing a nationwide, multi-step quality assurance program, which includes 10 basic production practices to improve food safety, herd health, and the environment. The Beef Industry Food Safety Council has developed a research agenda to reduce, or possibly eliminate, E. coli O157:H7.
And we are seeing many instances of new technology being used to make food safer. For example, slaughter plants are using antimicrobial rinses and steam vacuum technology to reduce pathogens on carcasses. And we recently proposed regulations for the use of irradiation on raw meatanother technology that companies can use.
We would like to see this trend continue. I believe that every responsible food business needs a corporate ethics program centered around food safety. Companies should teach their employees that safe products are the first essential corporate priority, and failure to handle food safely is an ethical violation.
In closing, adversity provides us with the opportunity for improvement, and I have provided you with several examples of how USDA has used adversity to spur significant improvements in food safety.
I hope that as you enter your professional careers, that you will take the right course of action when faced with difficult situationsboth from a public health standpoint and from ethical standpoint. There are no luxuries in the forest to which Shakespeares characters are banished, but they come away with something much more importanthonesty.
For Further Information:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704
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