In July 2004, U.S. Department of Agriculture (USDA) Under Secretary for Food Safety Dr. Elsa Murano released “Fulfilling the Vision: Initiatives in Protecting Public Health,” a document that reviews recent successes and builds on the course laid out in 2003 to improve the prediction and response to food safety challenges in order to further reduce the incidence of foodborne illness.

In 2003, Agriculture Secretary Ann M. Veneman challenged the Food Safety and Inspection Service (FSIS) to find creative and effective ways to continue to improve the safety of U.S. meat, poultry and egg products to better protect public health. FSIS, the public health agency of USDA, and its workforce of more than 7,600 inspection and veterinary personnel regulate the safety of these products in approximately 6,000 plants nationwide.

The publication of Fulfilling the Vision marks the result of FSIS’s activities to meet Secretary Veneman’s challenge. Fulfilling the Vision presents a list of accomplishments for 2003, including enhancement to BSE safeguards, the development of new FSIS employee training programs, strengthened food security measures and modernization of enforcement activities. In the document, Dr. Murano also lays out an ambitious agenda of agency initiatives for the future improvement of food safety (Read sidebar “Innovative Initiatives Inspire Improvements”).

Sworn in as Under Secretary for Food Safety in 2001, Dr. Murano, who oversees FSIS’s policies and programs, has emphasized the implementation of science-based standards and procedures as the primary focus of the efforts of FSIS personnel and policies. Under Dr. Murano’s supervision, FSIS has made impressive strides toward improving food safety by utilizing the best available science and technology, and adjusting FSIS’ workforce to support an increasingly science-based and public health-oriented food safety system. These science-based initiatives continue to contribute to the downward trend of harmful pathogen contamination observed in FSIS’s regulatory testing programs.

The accomplishments of Dr. Murano’s and FSIS’ regulatory initiatives can be observed in the annual report on the incidence of infections from foodborne illness by the U.S. Centers for Disease Control and Prevention (CDC). The report noted significant declines from 1996 to 2003 in illnesses caused by E. coli O157:H7 (42%), Salmonella (17%), Campylobacter (28%) and Yersinia (49%).

A native of Havana, Cuba, Under Secretary Murano holds a B.S. degree in biological sciences from Florida International University in Miami. She also holds a M.S. degree in anaerobic microbiology and a Ph.D. in food science and technology, both from Virginia Polytechnic Institute and State University in Blacksburg, VA. Dr. Murano is a tenured professor at Texas A&M University in College Station, TX.

In this exclusive interview with Food Safety Magazine, Dr. Murano provides further insight into last year’s accomplishments and the status of the agency’s blueprint initiatives, and discusses what it will take for the agency to fulfill its vision.

Food Safety Magazine: Dr. Murano, upon the release of “Fulfilling the Vision: Initiatives in Protecting Public Health,” which outlines FSIS accomplishments and introduces new initiatives to continue FSIS’s mission of ensuring food safety, you noted that “We must use science to identify our greatest challenges and meet them head-on.” Can you elaborate on this?

Dr. Elsa Murano: When I came to Washington three years ago, my aim was to use my scientific training to try to tackle the issues in food safety. I know from first-hand experience the importance of being as objective as one can in solving problems, using science as your guide. We have tried to translate that into a way of life at FSIS to meet food safety challenges. First and foremost, FSIS has worked to use the data that we collect within the agency and extract as much information from it as possible, including understanding what the data tells us in terms of food safety trends and where certain pathogens are located in a process or operation so that we can design strategies proactively to prevent these pathogens from ending up in food and meat and poultry products. Using science to analyze [all aspects of production] completely is called whole data analysis, and this is a very important tool for us to meet these challenges.

Also, it is very important to heavily rely on risk assessment. The collected scientific data of USDA and the data from studies carried out by researchers from universities, the Agricultural Research Service (ARS), and industry can help us to develop risk assessments to determine the risk level of certain practices in food processing that affect the risk of exposure to pathogenic organisms.

Those two things—whole data analysis and risk assessment—are the things I see as guiding lights in showing us where we need to put our focus. As a result, it is very important for me to do what I can to upgrade the level of scientific training of our inspectors. You can’t use science if the people in the field who are working with these issues on a daily basis are not scientifically adept or able to recognize signs that an outbreak is going happen if action isn’t taken to prevent it.

FSM: Among the agency’s accomplishments for 2003 detailed in Fulfilling the Vision are enhancement to BSE safeguards, the development of new FSIS employee training programs, strengthened food security measures and modernization of enforcement activities. Will you talk about these accomplishments in terms of improving the safety of meat, poultry and egg products in the U.S., especially in light of the implementation of the Bioterrorism Act and BSE-positive cattle found in the U.S. last year?

Murano: When we learned of the Canadian BSE-positive cow in May 2003, we started working to identify the risk mitigation and management strategies that we should incorporate into regulations to protect the American consumer from exposure to the BSE agent. At that point, we had not yet had a case of BSE in this country. However, with the positive case in Canada, a country that shares a border with the U.S., and with data from a risk assessment that Harvard University had conducted for us, we started working on these safeguards immediately in a science-driven and proactive mode.

Because of that proactive approach, on Dec. 23, 2003, when we found a BSE-positive animal in the U.S. that had come from Canada, it did not take us very long to respond. On Jan. 12, 2004, just under three weeks later, USDA published regulations that basically ban specified risk materials (SRMs), the infectious tissues from an animal that, if they were to be allowed into the food supply, would pose a risk to people. If we had not been proactively looking at BSE safeguards, it would have taken the agency much longer to respond because writing regulations takes months.

Banning SRMs is the single most significant measure that we have taken as a country to protect the food supply and consumers from BSE. The international review team that Secretary Veneman convened to evaluate the agency’s efforts in light of the positive cow found in the U.S., said exactly that, noting that FSIS’s ban was the most critical action we’ve taken because we’ve already protected the public by removing those materials from the food supply.

New FSIS employee training programs is another accomplishment that we discuss in Fulfilling the Vision, and this has been the hallmark of our ongoing initiatives. As I mentioned earlier in terms of science driving our policies and activities, if our workforce is not scientifically trained there will always be a gap in our ability to implement the science of food safety. This makes the training programs that we have implemented very important. We already had in place a cadre of professionals in the FSIS workforce who are Hazard Analysis and Critical Control Points (HACCP) experts called Consumer Safety Officers (CSOs), but we wanted to expand that training to other classes of employees so we expanded it to our public health veterinarians in charge of every slaughter plant in the U.S.

Why did we want to do this? When I first got to USDA, our employees were trained in how to implement regulations of HACCP but were not trained in the science of HACCP. In other words, employees in the field needed to be able to critically look at an establishment’s HACCP plan and know whether the hazard analysis was being done correctly or not. This science education was missing, and this is what the expanded training is allowing us to do. There are practical, hands-on training modules for our consumer safety inspectors assigned to the plants, the inspectors who are not vets, and they are receiving training in the science of food safety and HACCP that is tailor-made to the operations where they work, be it a slaughter plant or a plant that processes pepperoni.

Having our employees better trained has also allowed us to audit HACCP plans. When we see the tremendous decrease in illnesses due to E. coli O157:H7, a 36% drop in just one year, we know—and CDC has given the agency credit—that it is because of many actions the agency has taken. Specifically, we were able to order the reassessment of HACCP systems in the plants and then back that up with more extensively trained experts who could audit these plants using scientific methods. FSIS had never really done this before because we didn’t have the number of experts required to visit plants, conduct audits, or critically determine whether these HACCP plans were being implemented correctly or not. Now we have more personnel in the field who are scientifically trained in HACCP, and that’s been the real key to success.

We also list the implementation of food security measures as one of our 2003 accomplishments. After September 11, 2001, both USDA and FDA starting working very hard to implement measures to enhance the protection of the food supply—this time against intentional contamination. First and foremost, we established an office within FSIS, the Office of Food Security and Emergency Preparedness, which is charged not only with determining where vulnerabilities exist but also conducting a vulnerability assessment. The latter is similar to a risk assessment in that it is a very scientific process. The office also works with USDA laboratories to get them up to speed on methodologies used to look for threat agents that we normally don’t test. We have been testing meat, poultry and egg products for about a dozen threat agents that we previously did not in monitoring the food supply. The agency also has engaged in several simulation exercises, not only within the agency but also with other agencies within the USDA, and with FDA and CDC.

The Bioterrorism Act was very much focused on FDA instituting a system to require companies, especially foreign companies, to register with that agency in terms of when they were going to ship foods to the U.S. Conversely, FSIS did not need to institute any new systems in relation to the act because we already have a very robust import reinspection system in which governments of other countries are registered with the agency. These countries have the responsibility of proving to us that they have inspection systems that are equivalent to ours, have inspectors in every meat and poultry plant, have competent laboratories that do microbial sampling and analysis, have a whole system of training their inspectors and have HACCP in their meat and poultry plants. FSIS also routinely conducts in-country audits in which inspectors visit foreign plants at least once a year to make sure that all of required food safety and security systems are still in place, and the agency reinspects every shipment of all imported meat, poultry and egg products.

With all of these systems in place, FSIS’s role in the Bioterrorism Act was small. However, an important role is to directly assist FDA if there is an intentional contamination event. Specifically, the Bioterrorism Act includes a clause that FDA has the ability to deputize our inspectors to help FDA reach locations where they do not have personnel. Because we have a very strong field presence of 8,000 employees all over the country, FSIS personnel and inspectors are easily dispatched. If FDA identifies products that have been intentionally contaminated, for example, and there is a need to pull products out of many retail stores in many regions, FSIS field employees can be sent to those locations easily, even if those products are not egg, meat or poultry products.

Finally, Fulfilling the Vision recognizes that FSIS has made advances in modernizing its enforcement activities. We believe very strongly that we’ve got to do risk based inspection and enforcement. Only when we assign risk to particular operations or particular products can we better focus our resources and attention on where the problems really exist, rather than diluting efforts throughout all of the plants—in other words, whether they perform well or don’t or whether they produce high-risk product like fresh meat or very highly processed, low- risk product like pepperoni or canned beef stew. We’ve been doing a lot of work on this in pilot phases through our Program Enforcement Evaluation and Review Office, which has been testing some activities for us that will hopefully take us closer to focusing our resources based on the risk posed by certain products and processes.

FSM: According to published data, there were no multimillion-pound recalls of meat products in 2003, as we experienced in previous years in the U.S. To what do you attribute this statistic?

Murano: You’re absolutely right. In fact, when you look back from 1997 to 2002, in every single year there was at least one multimillion-pound recall of either meat or poultry products. In 2003, we broke that cycle and I certainly attribute this to our use of science to develop either regulations or actions to reduce the incidence of such recalls. For example, one of the actions was the call by FSIS for a reassessment of HACCP plans in ground beef producing plants and slaughter plants, which I believe played a big part in reducing by 42% the number of E. coli O157:H7 related illnesses in 2003 as reported by CDC. We were able to conduct scientific audits of those plants to make sure that plans were being carried out correctly, which had not been done before. I give credit to industry because they did reassess their plans and about 62% of those companies significantly revised their HACCP plans as a result. Industry stepped up to the plate, critically looking at their HACCP plans and changing and improving their programs when they saw that they needed to. When you couple that with our auditors’ enhanced scientific know-how to critically examine how that was done certainly contributed to the decrease in E. coli-associated illnesses.

Similarly, in the case of Salmonella, an organism that is commonly found in many foods, a change in an FSIS action contributed to the reduction of salmonellosis. Previously, FSIS’s Salmonella level testing protocol required that if up to a certain percent of positive samples were found in a sampled lot that the agency would allow them (a performance standard), and further, that an in-depth review of a company’s operations, HACCP plan, sanitation program, etc., by FSIS was triggered only if a company exceeded the performance standard several times. We changed this approach to the performance standard testing because we realized that upon the first failure was when we needed to go into an operation and look critically at what the establishment was doing or not doing in terms of food safety. I believe that this change also has contributed to the decrease in product being contaminated with Salmonella. Of course, E. coli and Salmonella tend to live in the same places and so when you do things to reduce one, you typically will see a reduction in the incidence of the other.

Another example shows how a new regulation to combat Listeria monocytogenes spurred the reduction of illnesses associated with the pathogen. The Listeria regulation was based on a risk assessment that took us a long time to develop because of the large amount of data required. Risk assessment is only as good, robust and reliable as the data that you put in. We gathered a lot of data from various sources, including university, government and industry studies, which gave us enough risk assessment data that we could plug the data into a mathematical model and see the effect on risk of various Listeria reduction or elimination strategies that might be required of industry in developing the regulation.

The risk-based components in the final regulation has resulted in a tremendous change in behavior in the segment of industry that produces ready-to-eat (RTE) meat and poultry products. About 87% of those companies that produce RTE meat and poultry products have changed their operations in some way as required by the Listeria regulation. And that percentage of change is so significant that it has caused any contamination of product by Listeria to occur in very small volumes per 100 pounds because operators are better able to predict the location of Listeria in the plant and eliminate it with sanitation methods before it ends up in product, or actually prevent Listeria by adding inhibitory ingredients in the formulation of the product or by adding a pasteurization step after the product is packaged. Because of the extensive risk assessment, we knew that if the RTE meat and poultry industry followed any of the strategies provided in the final regulation that there would be a significant reduction in the risk of contamination of product with this pathogen.

FSM: Similarly, what kinds of food safety strategies or systems contribute to the reduction in illnesses associated with E. coli O157:H7, Listeria and Salmonella as reported by the CDC?

Murano: The first part of developing a HACCP plan is to do a hazard analysis. By analyzing the hazards that are likely to be present given the product you produce and the process by which you produce it, you will see what particular pathogen is likely to contaminate your product. HACCP demands that you have some control step in place to address this, and as a result, many meat and poultry plants have been proactive in developing and implementing technologies that seek to reduce, if not eliminate, pathogenic microorganisms in plant and product. Such technologies include organic carcass rinses with citric or lactic acid, which will get a certain log reduction in bacteria; steam pasteurization, which is shown to have some effect in reducing bacteria from the carcasses; and steam vacuum devices to clean the surface of the carcass. In the case of RTE products, introducing inhibitory ingredients in the formulation of sausage products, cold-cuts and so forth has certainly contributed to the decrease in microorganisms, as well.

It is these kinds of advances that can only happen if your HACCP program is sound. If it isn’t sound and you don’t consider certain pathogens as likely to occur in your products, you won’t feel that you need to have one of these control steps. It follows that if you’ve done your hazard analysis correctly and you determine a pathogen like E. coli is likely to be found in your product, then HACCP demands that you take some step to control and prevent the microorganisms from growing or even to eliminate it, which is certainly the ideal. Industry operators have been very innovative really in looking at what they can do to contribute to reducing the risk of microbial contamination, including conducting research and development in novel non-thermal microbial reduction technologies.

On a related note, I did not want FSIS to be a stumbling block to progress in the development and use of such technologies. In the past, bureaucracies being what they are (and government certainly is a bureaucracy), you can’t let things take so long to be approved for use in a processing plant environment that by time you’ve approved it that technology either is obsolete or you’ve allowed product that could have been better decontaminated from being treated with a new technology. What we’ve done is establish a New Technology Approval Office to expedite the use of new technologies within plants as pilot projects, so that the technology developers can prove to us that the technology works. These technologies have already gone through a safety review by FDA. For example, lactoferrin is an ingredient that has been shown by research to be very effective in eliminating E. coli O157:H7. This is an ingredient that FDA would approve but FSIS, through our New Technology Approval Office, worked with FDA to encourage them to work as fast as they could to get that technology reviewed, so that if it was deemed to be safe—and it certainly was—that it could be used by industry as soon as possible. It is in our interest at FSIS to assist in expediting a technology that will make meat and poultry safer, even if it is not something that we directly approve.

FSM: In Fulfilling the Vision, four new initiatives are cited. Can you describe each of these initiatives and how they will improve the nation’s food safety objectives and standards?

Murano: Certainly. The first initiative is to apply risk to FSIS regulatory and enforcement activities using the Hazard Control Coefficient (HCC), a measurement of the effectiveness of pathogen controls used by individual establishments. With HCC, we are basically looking at the universe of meat, poultry and egg product manufacturing plants— approximately 6,500 plants in the U.S. In that universe, we know that some of those plants do a very good job of following our regulations—they have good sanitation, their HACCP plans are great, they are very proactive with intervention technologies, and they are doing everything possible to ensure food safety and compliance. On the other hand, there are plants that just do the bare minimum and maybe we have to be very vigilant and stay on top of those plants so they do not stray, if you will. In that universe of 6,500 plants, we also know that some plants make products that we define as high risk, such as raw ground beef that can be contaminated by pathogens and if not cooked properly by the consumer, cause illness. Similarly, some of those plants manufacture very low-risk items, typically highly processed products that will not support the growth of bacteria or have been treated in such a way that they are commercially sterile, such as canned beef stew.

We wanted to combine those two factors—the ability to comply with our regulations by plant with the risk of the actual product produced in those plants. We came up with a concept where you can assign a number based on the degree to which a plant complies and the degree of risk of product produced. At the end of this risk analysis, you end up with a population of plants where some of them, hopefully a lot of them, comply very well with our regulations and produce very low risk products—those would be plants that FSIS wouldn’t have to scrutinize as much or take as many samples from. With plants that are very good at adhering to our regulations but produce very high risk products, we certainly would continue to monitor those very closely but likely not as much as plants that produce high-risk product and have a history of bad adherence to our regulations. Obviously, the latter are the ones on which we want to concentrate because we want to eventually take them out of that quadrant of bad performers, so to speak. To do that, we have to focus our resources and our experts to find out what it is that these plants are doing or not doing correctly, take enforcement action if we need to, or help them through guidelines because they don’t have the resources to train their people.

HCC is a very good concept that is being piloted right now in one of our district areas, and we are learning a lot from it because not only is it going to be useful in terms of where should we focus our resources, but it can also give us a look as to where within FSIS’s 15 districts do we have plants that need the most focus. Also, if we see a lot of the bad performers in a particular district, we want to ask whether it is because our inspectors are not doing an adequate job or some other factor. HCC may be a tool for us to look internally at our performance as inspectors at FSIS.

As I said, we’re piloting the HCC concept to see what works and what doesn’t work. The first thing we are trying to figure out is, once we assign these coefficients, are they accurate? For example, on paper you might see that one plant receives a lot of write-ups for non-compliance and another plant is not written up very much but when you actually visit both of those plants they are at same level of compliance. It may be that at one plant the inspector writes more reports than the inspector at the other plant, and it is that inconsistency in inspection that we also want to correct. We want to make sure that our inspections are consistent across the board and not inspector-dependent.

The focus of another initiative is associate program outcomes to public health surveillance data. We rely on CDC with this one. CDC collects all data on foodborne illnesses through its FoodNet Surveillance system, but this data is on all foods and frequently CDC does not know what food was attributed a particular outbreak because the hospitals and medical offices may not have that information. So, when they report illnesses they don’t report them according to product and it is important to us that they provide us with illnesses according to product because it is really the best way that we’ll know that what we’re doing is working or not.

In the case of illnesses linked to E. coli O157:H7, the vast majority of those illnesses are going to be from ground beef. We know that from science. But how about salmonellosis or listeriosis? Those illnesses are caused by a variety of foods. Right now, for example, we are seeing a big outbreak of salmonellosis from tomatoes. So, we know that Salmonella is carried by a variety of foods and if we see salmonellosis cases increasing, we want to know whether it is because of something we failed to do or if it is because FDA needs to do something more because it affects products that they regulate. It is very important for USDA and FDA to get attribution data, meaning illnesses and the products to which they are attributed. We have a liaison person who is housed at CDC in Atlanta to try to develop a way for CDC to collect some of this the data, if not on every single case at least in enough cases that we can statistically get a good picture of what’s happening.

The third initiative is centered on improving food safety beyond our borders. We just announced a new virtual Institute of Food Safety for the Americas, which is a project that we believe in very strongly. It is going to improve the safety of products produced in Latin America. We are focusing on our neighbors to the south because they are the folks with which we trade the most. We have partnered with the Pan American Health Organization through a signing of a Memorandum of Understanding (MOU), and with various universities like Miami-Dade College in Florida in this effort. We plan to have training modules in food safety and security delivered in a long distance virtual mode, and when necessary, offer workshops in Miami, which is the most convenient U.S. location for people traveling from Latin America. We’re very excited about it. It’s a new concept, and if it works as well as we think it will, it is something that we hope to expand to other regions of the world.

Enhancing data integration is the fourth new initiative discussed in Fulfilling the Vision. All of the data that FSIS collects in the regulatory sampling program is great but it is nowhere near the amount of data that is collected by the food industry. They do a lot of testing themselves, which is great because they need to monitor what is happening in their plants and they are required by HACCP to use testing as a verification that they have control over their operations. While we have access to the data that is collected because of HACCP verification activities, we do not have access to other microbial prevalence or trending data that plants may be collecting that would give us a better idea of where the gaps are and where to focus our research efforts.

It would be helpful to us and the industry if there was a third-party, independent repository where all of that data could be collected and analyzed while maintaining the confidentiality necessary to provide incentive to companies to want to share that data. This is a tricky endeavor because if there is data out there that shows that there is a danger to the consumer and we know that is the case, we are required by law to act on it. Certainly, companies discover adulterated product are required to act on that information, as well, but they may not be so eager to share that data and they may simply take corrective action and not let us know. We want to be able to give incentive to industry to put all that information in one location that can be managed by someone who doesn’t have the reporting requirement that a regulatory agency has, and have that data be available to everyone.

FSM: Fulfilling the Vision discusses accomplishments and initiatives for 2003. Do you have any comments on 2004 thus far?

Murano: In July, there was a Gallup poll published that focused on the consumption habits. Part of the poll had to do with the confidence that consumers have in the government to protect the food supply, comparing 1999 to 2004. According to that survey of American consumers, in 1999 about 76% of respondents had either a fair amount or a great deal of confidence in the safety of the food supply. In July 2004, the latest poll reported about 86% of the consumers surveyed saying they have a fair amount or a great deal of confidence in the food supply.

This is about a 10% increase in confidence over the last few years, in spite of mad cow disease, some multimillion-pound recalls as mentioned earli