FOOD SAFETY AND INSPECTION SERVICE
Submitted for the Record
Statement of Dr. Elsa Murano, Under Secretary for Food Safety, Before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies

Mr. Chairman and Members of the Subcommittee, I am pleased to appear before you today to discuss the Fiscal Year (FY) 2004 budget for food safety within the Department of Agriculture (USDA). I am Dr. Elsa Murano, Under Secretary for Food Safety. With me today are Dr. Merle D. Pierson, Deputy Under Secretary for Food Safety; Dr. Garry McKee, Administrator of the Food Safety and Inspection Service (FSIS); and Linda Swacina, Associate Administrator.

The safety of our food supply is one of the most important issues we face not only at USDA, but as a nation: there is nothing more personal or vital to all of us than the food we provide to our families. President Bush’s budget for FY 2004 includes record-level support for USDA’s food safety programs and their basic mission of providing continuous food safety inspection in each meat, poultry, and egg products establishment in the country. The additional $42 million requested for FSIS will be used to fund several important initiatives that I would like to review with you in a moment.

Before I cover those initiatives that will be implemented from the additional $42 million requested for FSIS, I want to discuss what has happened in the past year, our progress on the five goals to improve food safety, our efforts to improve international food safety, and our plans for the upcoming future.

What Has Happened During The Past Year

We have the best food production and processing systems in the world, providing consumers with the most abundant and safest food supply. However, last year was a testament that maintaining the safety of our food is an ongoing challenge. We faced two outbreaks, one caused by Listeria monocytogenes, another caused by E. coli O157:H7.

We take our public health mission very seriously, and we will do what is necessary to accomplish that mission. According to the Centers for Disease Control and Prevention (CDC), over the past decade, there has been a major Listeriosis outbreak associated with ready-to-eat products in the United States every two to four years and E. coli O157:H7 due to consumption of undercooked hamburgers are almost an annual occurrence.

Despite these challenges, we have made significant improvements to our food safety program. We believe that the Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) rule in 1996 has made food safer. In May 2002, the CDC reported that the rate of foodborne illnesses, across the board, is down 21 percent.

We have also made great strides in improving the technical and scientific knowledge of our inspection force. With the introduction of the Consumer Safety Officer corps we have introduced highly-skilled, scientific experts into the field to reinforce our veterinarians and front-line inspectors. We are driven by the fact that the enormity of our responsibility cries out for a science-based system and we continue to incorporate state-of-the-art science into the inspection process at every opportunity.

Those strides are great, but we need to address how we are going to protect public health further. Throughout my career as a researcher, I have become keenly aware of the importance of sound scientific studies and how these can help provide us with the critical information and practical application of science we need to make decisions that will truly reduce the risk of foodborne illness. I have also observed the need for a proactive approach, one that does not simply react to food safety crises, but rather anticipates risks and prepares to mitigate their potential for harm. We need to improve across the board in everything we do including our public education campaigns; laboratory testing; inspector training; and in-plant inspection.

The Five Goals To Improve Food Safety

I want to review some of the achievements we have made in improving food safety. Last year when I testified before this Committee, I outlined to you five goals that I intended to pursue in the coming year to ensure that we are proactive in protecting public health. We have pursued these goals with an aggressive vigor, and we continue to do so. I am proud to report that much has been accomplished over the last year in our pursuit of these goals to ensure the safety of the nation’s food supply.

Before, I cover our accomplishments under each of the five goals, I would like to review them quickly. They are:

1. Ensure policy decisions are based on science;
2. Improve the management and effectiveness of FSIS programs;
3. Improve coordination of food safety activities with other public health agencies;
4. Protect meat, poultry, and egg products against intentional harm; and
5. Enhance public education efforts.

Goal #1: Ensure Policy Decisions are Based on Science

My first goal is to ensure policy decisions are based on science.  As I mentioned earlier, employing science is the only way we are going to break the cycle of foodborne illness.  My background as a researcher in food safety has shown me the importance of utilizing science in formulating regulatory policy. 

If we take a look at two pathogens that have been on our radar screen – E. coli O157:H7 and Listeria monocytogenes – then we see that these organisms are representative of the universe of microbial hazards that pose the biggest threat to the safety of our food supply.

The first one, E. coli O157:H7, comes to us through the live animal, mainly cattle, and it reaches consumers when meat has been in contact with manure contaminated with the organism.  Thus, its control hinges on minimizing its presence in the intestinal tract of food animals and in preventing its contents from reaching raw products derived from these animals. 

The second pathogen, Listeria monocytogenes, is an environmental pathogen, carried by equipment personnel, and water when food has been in contact with contaminated equipment, personnel, and water.  Thus, its control hinges on finding where it might be harbored in the environment of the food processing plant and thus eliminating it so as to prevent contamination of food-contact surfaces. 

Risk assessments are the way to measure the pervasiveness of these organisms.  Risk assessments are scientifically-based processes of estimating the likelihood of exposure to a hazard and the resulting public health impact.  They provide a solid foundation from which we base policies on science.   Making policy decisions without them is akin to shooting at a target in the dark.  You have no idea if you hit your mark. 

The benefits of using them can be seen in our initiatives on E. coli O157:H7 and Listeria monocytogenes last year.  We learned from our risk assessment on E. coli O157:H7 that the pathogen was not the proverbial needle in a haystack we once believed.  On the contrary, it was much more prevalent than previously thought, which meant that we had to take a hard, new look at our strategies to address its occurrence.  We also learned that not all establishments were implementing HACCP systems that were effective for controlling E. coli O157:H7.  Others were not correctly validating the interventions used to control the pathogen.  Finally, we realized that simply focusing on grinding operations was not effective; therefore, in order to be efficient, we also needed to focus on the production process, the slaughter process, and trimmings as contributors to the problem.

In December, we issued an interim directive to our inspectors to make sure that establishments producing ready-to-eat meat and poultry products are preventing Listeria monocytogenes contamination.  This directive was absolutely necessary given the gravity of the Northeastern Listeriosis outbreak in the fall.  Furthermore, we recently completed a draft risk assessment on Listeria, which evaluates all the factors that potentially contribute to the overall risk to public health.  The information developed during the risk assessment process is critical to exploring a variety of risk management scenarios and we plan to examine different combinations of testing and intervention that present possibilities for future policy making.  We will consult the risk assessment as we work on a final rule to reduce Listeria in processing plants producing ready-to-eat meat and poultry products.  We are committed to moving as rapidly as we can to develop this final rule while using sound science as the basis.

In a perfect world, risk assessments would be completed before risk management strategies are developed.  But in the real world, we may not have this luxury.  We must design risk management strategies based on what we know today and improve them as more information becomes available.

Another way we have based policy decisions on science has been through a series of scientific symposia we hosted on specific issues ranging from applied epidemiology, pathogen reduction, and Listeria.  These symposia offer an opportunity to hear from experts in academia and government and allow for a dialogue on how we can improve the scientific basis for our food safety programs and policies.

Goal #2: Improve the Management and Effectiveness of FSIS Programs

The second goal I’d like to discuss is improving the management and effectiveness of FSIS programs. In order to fulfill this goal, we needed to select a leader to head FSIS through one of its most profound transformations toward a public health mission.

I was looking for certain traits in this individual. These included a scientific background, strong management skills, and a sense of accountability to everybody in the organization. This person would also have to be a motivator.

I am truly proud to say that I have found all these traits in the selection of Dr. Garry McKee, who started on September 1, 2002. In this very short time he has made a very positive impression on agency employees and constituents alike. Dr. McKee is a committed public health professional with over 30 years of public health experience and a proven leader in managing public health programs and personnel. He brings unparalleled enthusiasm, determination, and commitment toward public health to the helm of FSIS and I certainly believe that his tenure will be regarded in the future as a significant turning point in FSIS’ long history.

The selection of an Administrator was critical, but so too was the reorganization of the agency that I started last year. This reorganization will prepare the agency to better meet its public health and food safety goals. The purpose for this reorganization is to increase accountability, enhance communication, and improve overall efficiency.

With Dr. McKee’s leadership, we are already seeing increased accountability for all FSIS employees; improved communication that flows smoothly and quickly through the organization as well as laterally across all divisions and to outside agencies; and increased efficiency in the agency’s programs. As a public health agency, lives depend on our programs and operations to work as a finely tuned machine.

This reorganization will also ensure that the principles of public health and food safety cut across the entire spectrum of FSIS’ work. We have added four assistant administrators for Food Security; Program Evaluation, Enforcement, and Review; Communications, Outreach and External Review; and International Coordination to strengthen the working relationship between our various offices.

In addition to our reorganization, FSIS is continuing the pilot inspection system, known as the HACCP-based Inspection Models Project, or HIMP, to address the online slaughter process. I view HIMP as a total food safety and process control system, and it is an example of another initiative we are pursuing to increase the efficiency of our programs.

Under HIMP, volunteer plants take a more active role in the carcass sorting activities, while FSIS inspectors concentrate on more intense inspection and verification activities. In June 2002, FSIS made data available comparing HIMP and traditional inspection, which showed improvements in detecting and controlling quality concerns and food safety measures in HIMP pilot plants. The data showed no change in the incidence of dressing defects, such as feathers, or in the prevalence of Salmonella. In September 2002, an independent review of the HIMP data concluded that “the HIMP system compared favorably to the traditional system of inspection.”

Goal #3: Improve Coordination Of Food Safety Activities With Other Public Health Agencies

We have also made progress with the third goal to improve coordination of food safety activities with other public health agencies. I am a strong believer that by working together, all the agencies with public health responsibilities can best utilize our resources to ensure a safe food supply.

An example of our progress in this area was an unprecedented investigation that we coordinated with the CDC and other State and local public health agencies on the Northeastern listeriosis outbreak that caused 54 illnesses, eight deaths, and three miscarriages/stillbirths.

Another example is our very close working relationship with the Food and Drug Administration Commissioner, Dr. Mark McClellan. We have established regular meetings with Dr. McClellan’s office to increase our interaction on issues of mutual concern and to discuss policy positions of common interest.

States are also an integral part of the U.S. food safety system. We are continuing to take steps to improve Federal-State cooperation on State Meat and Poultry Inspection (MPI) Programs. For example we are working in close cooperation with State program directors on the National Criteria for Meat and Poultry Inspection Programs – a project to update, clarify, and simplify requirements for cooperative State meat and poultry inspection programs.

Another area where we are making major strides in cooperation with States is sharing recall information. In July 2002 FSIS published a final rule allowing the agency to share a firm’s distribution list with State and Federal agencies in the event of a meat or poultry recall through a Memorandum of Understanding. This change allows for better communication and coordination between FSIS and the numerous State and Federal agencies that are involved in product recalls.

Goal #4: Protect Meat, Poultry, and Egg Products Against Intentional Harm

Close coordination with other public health agencies is also very important in protecting the food supply against intentional harm, which leads me to the fourth goal. Since the attacks on September 11, 2001, FSIS has strengthened coordination efforts to prevent, detect, and respond to food-related emergencies resulting from acts of terrorism, and ensure the safety of meat and poultry and egg products that come to us from other countries. With a strong food safety infrastructure already in place, FSIS has been able to focus on fortifying existing programs and improving lines of communication, both internally and externally.

We have implemented several measures to protect the public from contaminated product entering the United States from abroad. In addition to reinspecting imported product, FSIS continually assesses foreign establishments to make sure their sanitation and inspection procedures are equivalent to those in the United States.

FSIS has also added 20 new import surveillance liaison inspectors who are on duty at ports of entry to augment the efforts of traditional FSIS import inspectors. These new import inspectors will not only examine each shipment and conduct reinspection activities, but they will also conduct a broader range of surveillance activities at each import facility and serve as liaisons to improve coordination with other agencies concerned with the safety of imported food products, such as the Department of Homeland Security.

Furthermore, FSIS introduced the new Automated Import Information System (AIIS), which focuses on a foreign country’s inspection system as a whole, rather than on individual plants. This system, using statistics, chooses imports for reinspection based on the annual volume of shipments from the exporting country. Previously, for all countries except Canada, reinspection was randomly assigned based on an establishment’s compliance history. The new system is user-friendly and allows inspectors at all ports-of-entry to share data. It also allows managers to have easier access to inspection reports. The new AIIS system also provides better tracking of shipments once they enter the United States, and FSIS’ next step is to integrate the system with the Department of Homeland Security’s system to further strengthen the food safety system against intentional attacks.

Besides our initiatives to screen imported products, we have conducted a risk assessment to be used as a tool for determining the most vulnerable products, likely agents, and potential sites for deliberate adulteration of domestically produced meat, poultry, and egg products. The assessment was conducted using a farm-to-table approach based on current knowledge of the industrial processes used in the production of these products and the potential biological and chemical agents that could be introduced. The assessment was concluded in June 2002 and the information obtained is being used to develop risk management strategies, including ensuring that our laboratories are equipped with the methods and personnel necessary for detecting agents of concern.

We are also developing a threat assessment of the import system to identify points in the production of imported products where biological, chemical, and radiological contaminants could be intentionally added to foods being brought into the United States. FSIS used the risk analysis framework to conduct a relative risk ranking to be used to allocate resources to monitor U.S. ports of entry for those food commodities that pose the greatest risk, examine different intervention strategies for preventing or reducing risks, develop biohazard identification protocols, and target training of personnel and develop educational campaigns to increase awareness. This assessment is expected to be completed in September 2003.

We have taken preparation for food safety emergencies to a higher level with simulation exercises. Recently we conducted an exercise known as “Crimson Winter” to familiarize our managers and staff with the operating environment that would exist during an outbreak of foodborne disease – the cause being intentional or unintentional. This exercise was very constructive for our senior management, emergency response team, our partners in the Food Threat Preparedness Network, and other relevant Federal and State agencies.

Goal #5: Enhance Public Education Efforts

Finally, goal number five is to engage in proactive education programs. Food safety education is a critical element of the risk analysis framework, which includes risk assessment, risk management, and risk communication. It is a risk management strategy because educating food preparers is an important way to reduce the risk of foodborne illness. Education is also a risk communication function because it serves to alert the public about a hazard that exists and can be addressed by safe food handling and food selection.

As we continue to examine emerging and existing food safety problems, it is important that we remember that reducing foodborne illness requires numerous interventions all along the farm-to-table chain. We must consider all the strategies available to us – and education is one of them – to make the food supply safer. That is why we continually look for the most cost-effective ways to get the food safety message out to all food handlers from coast to coast.

I have been travelling around the Nation conducting media interviews and delivering food safety education messages through an aggressive campaign; however, my time obviously is limited. This is why we have pursued an even greater amount of coordination among government, industry, and consumer groups to deliver food safety messages to all food handlers and preparers.

Last year FSIS partnered with the Food and Nutrition Service to provide new educational materials to schools and child care facilities. We also are actively engaged in the Partnership for Food Safety Education, which is a public-private coalition dedicated to educating the public about safe food handling preparation to help reduce foodborne illness.

We all have to realize as well that education is not just about the basics of food handling. There are many new effective products and technologies in the marketplace that can be used to reduce pathogens and food preparers need to be educated about them. Basic and thorough education is needed to change misconceptions about their applications.

Irradiation is a good example of a technology that is misunderstood by the public. We were charged by the recent Farm Bill to conduct an education program on the availability and safety of new technologies that eliminate or substantially reduce the levels of pathogens in meat and poultry products. Last year we convened a meeting with a group of experts on pasteurization/irradiation to start developing an education program. We expect much to come out of this group as we continue to develop and deliver an effective education program for pasteurization/irradiation.

Efforts To Improve International Safety

The U.S. food safety system is the gold standard for the world. Because we have the same safety requirements for the U.S. meat and poultry produced for export and for products entering the United States, our efforts have a worldwide impact.

Food must be safe to eat worldwide in addition to being available and nutritious. Having safe food available to citizens around the world is vital for protecting global health. Without safe food, we face a tremendously high number of foodborne illnesses, which significantly burdens nations – both developed and developing with short- and long-term health problems and economic costs.

For this reason, we are fully committed to working with our international partners in ensuring a safe food supply worldwide. We lead the U.S. office of the Codex Alimentarius Commission, and we are actively engaged in the activities of this Commission, which is an international standard-setting body for food safety. Our active input into Codex contributes to decisions that have profound effects on national economies and the health and well being of citizens around the world. It is in our national interest to maintain our leadership role in Codex in order to ensure food safety regulations around the world are reasonable, equitable, and achievable.

Another example of our commitment to international food safety is through education. Last year, we cosponsored with the U.S. Department of Health and Human Services a conference which brought together food safety educators from all over the world to focus on the food safety education implications of the global nature of the food supply. It is my goal to make these make these food safety conferences annual events.

We also reached out to rural women worldwide through participation in the Third International Congress on Women in Agriculture held in Spain last year. We delivered our food safety education message at this conference since many women around the world have a tremendous amount of responsibility for food preparation.

RISK ASSESSMENT

Our talented and dedicated leadership team has made it clear to the FSIS workforce and to industry, that science will dictate our food safety programs. At the moment, there is no formal infrastructure for science-based policy making. We are working hard to rectify this. You cannot craft a solution in this highly complex food production world if you have not specifically identified the problem.

Currently, we operate under a number of different models and sometimes are required to change policy as new crises emerge. I believe there is a better way. Government, industry, foodservice, academia and all other interested parties need to come to terms on how best to conduct risk assessments. If successful then such a plan would be the first of its kind in the world. The United States has always been the leader in food technology and science. Now we can demonstrate it once again in a way that will benefit the health and well being of all of our citizens.

In some fashion, we need a central, state-of-the-art source for development of risk assessment models. We are working now on designing such a plan. It is getting increasingly difficult to manage a threat when we are unsure of its pervasiveness. Risk assessment provides this vital data. The benefits of using risk assessments can be seen in our recent initiatives on E. coli O157:H7 and Listeria monocytogenes that I discussed earlier. This process needs to be strengthened, formalized, and continually supported in order to be used to its full potential.

To be effective, we need to both analyze current threats to the food supply and anticipate problems that may arise. Presently, this is not being done. There are times when we work in a completely reactive mode and I do not think this serves us well when we try to anticipate new challenges.

I am well aware that there are gaps in our current universe of food safety research and until we close the gaps we will not be able to fully understand, or control, the farm-to-table continuum. We need to bring the brightest food safety minds from throughout the country together in a way that will help the Federal government, industry, foodservice and the American people.

VALIDATED DECONTAMINATION METHODS

We need to focus on the application of validated decontamination methods in order to reduce pathogens. A conscious effort has been made when drafting FSIS’ Notices and Directives to encourage industry to utilize new decontamination technologies. Scientific and technical innovation that keeps our food safer should be encouraged. However, validation of such technologies in the plant is not far enough along and efforts to improve this must be pursued.

My hope is that industry, foodservice, academia and USDA’s Agriculture Research Service will work together to develop intervention methods that will be validated at the various stages of the food chain and then applied from farm-to-table. Once these technologies prove successful then they need to be approved in a fast-track manner. Government needs to respond efficiently and effectively when technological safeguards become available and help, not hinder, industry in its implementation of these food safety innovations.

Initiatives From The FY 2004 Budget Request

I have great hope that we will arrive at the next generation of food safety in this country when we implement these steps. At this time, I would like to focus on the initiatives of the FY 2004 food safety budget request and indicate how this additional funding will help us reach our goals.

The FY 2004 budget request supports FSIS’ basic mission of ensuring continuous inspection in each meat, poultry, and egg products establishment in our country and reinspection of imported product. It also reflects President Bush’s deep concern about ensuring a strong food safety system. His record level budget request for food safety programs will allow FSIS to continue working to fully implement the goals we have laid out, but will also allow us to pursue new initiatives.

USDA’s food safety budget requests a program level of $899 million, an increase of $42 million over the enacted level for 2003. This funding represents a $148 million, or 23 percent, increase for USDA food safety activities since FY 2000.

The $42 million increase in the FY 2004 budget to strengthen FSIS’ food safety program encompasses $23.6 million in increases to cover raises in employees’ salaries and benefits, the costs of inflation, and FSIS’ support of State-inspection programs.

The other part of the budget increase covers $19.3 million in initiatives to fund the hiring of more food safety inspectors, provide specialized training for the inspection workforce, increase microbiological testing and sampling, strengthen foreign surveillance programs, and increase our public education efforts.

As I mentioned, it is absolutely necessary that we use science to improve food safety. One of the ways the President’s budget helps us do that is through the $1.7 million to include baseline studies on variety of pathogens, including E. coli O157:H7. This funding will allow us to collect data on the presence of microbial hazards, and it is a crucial component used in developing risk assessment models – hence the backbone of effective policy making.

Another means of employing science is the strategy of equipping our frontline workforce with the scientific and technical expertise. The $5.7 million requested in the President’s budget will help us expand our in-depth HACCP training to all our veterinarians and inspectors. With these resources, we will be able to increase consistency and effectiveness of inspection, thus making our food safer.

Along with this notion of a well-trained inspection workforce, is the fact that FSIS needs to have a full complement of inspectors. For this purpose, the President’s budget requested $4.3 million in funding to increase our workforce to 7,680 in-plant staff by adding 80 new positions. These 80 positions are necessary to meet the demands of industry growth.

When a foodborne outbreak occurs, it is essential to identify the source of the outbreak so that the agency can take swift action to prevent further illnesses and warn the public of the adulterated product.  Therefore, the FY 2004 budget request includes $4.5 million to provide additional microbiologists, chemists, laboratory technicians, and other personnel to increase the agency’s ability to identify adulterants in meat, poultry, and egg products.  This funding will help the agency develop analytical methods to test food products for chemical, biological, and radiological contamination.  This initiative would also increase sampling of ready-to-eat products for the presence of bacteria such as Listeria monocytogenes and Salmonella.  FSIS would increase sampling of these products from 10,000 to 15,000 annually and would add the capability to conduct 5,000 Listeria monocytogenes environmental samples annually.  The agency also plans to increase sampling of raw ground beef and raw ground beef ingredients for E. coli O157:H7 from 7,000 to 15,000 samples annually.

Additionally, the President’s budget includes $1.8 million to increase the number of foreign program auditors, thereby strengthening our oversight at the location where the food is actually produced or manufactured for export to the United States. This augments our existing strong system of ensuring that imported food is safe.

Our public education efforts, which I discussed earlier in the five goals, are one avenue we are aggressively taking to make sure that all food handlers and preparers follow safe food handling practices to reduce foodborne illness. The President’s budget request for an additional $1.5 million for food safety education is a prime example of how we can explain the importance of safe food handling and preparation.

Finally, the FY 2004 budget request also includes a proposal to recover the costs of providing inspection services beyond an approved eight-hour primary shift. FSIS already collects $102 million in reimbursable fees to recover the costs associated with overtime, holiday, and voluntary inspection services. Under the FY 2004 budget, legislation will be proposed to collect user fees for inspection services beyond one approved eight-hour shift per day. If approved by Congress, it will enable the agency to collect approximately $122 million more in user fees and reduce our appropriated request from $797 million to $695 million. This will result in a savings for the American taxpayer.

Closing

In closing, I want to emphasize we already have a strong infrastructure in place, achievements made in the goals we are aggressively pursuing, and a strong leadership team to direct our way toward our ultimate goal of protecting public health.

The President’s budget for FY 2004 provides us with a historic opportunity to -- not only do what is right -- but to do what is needed, which is to employ science to its fullest potential to make food in the United States as safe as possible. With the support and assistance of this Administration and Congress, I am confident we are well on our way to improving public health.

This concludes my written statement. I want to thank the Chairman and members of the Subcommittee for the opportunity to testify on behalf of USDA’s Office of Food Safety, and welcome your questions.