[Senate Hearing 106-366] [From the U.S. Government Publishing Office] S. Hrg. 106-366 ``OVERLAP AND DUPLICATION IN THE FEDERAL FOOD SAFETY SYSTEM'' ======================================================================= HEARING before the OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE of the COMMITTEE ON GOVERNMENTAL AFFAIRS UNITED STATES SENATE ONE HUNDRED SIXTH CONGRESS FIRST SESSION __________ AUGUST 4, 1999 __________ Printed for the use of the Committee on Governmental Affairs U.S. GOVERNMENT PRINTING OFFICE 61-665 CC WASHINGTON : 2000 _______________________________________________________________________ For sale by the Superintendent of Documents, Congressional Sales Office U.S. Government Printing Office, Washington, DC 20402 COMMITTEE ON GOVERNMENTAL AFFAIRS FRED THOMPSON, Tennessee, Chairman WILLIAM V. ROTH, Jr., Delaware JOSEPH I. LIEBERMAN, Connecticut TED STEVENS, Alaska CARL LEVIN, Michigan SUSAN M. COLLINS, Maine DANIEL K. AKAKA, Hawaii GEORGE V. VOINOVICH, Ohio RICHARD J. DURBIN, Illinois PETE V. DOMENICI, New Mexico ROBERT G. TORRICELLI, New Jersey THAD COCHRAN, Mississippi MAX CLELAND, Georgia ARLEN SPECTER, Pennsylvania JOHN EDWARDS, North Carolina JUDD GREGG, New Hampshire Hannah S. Sistare, Staff Director and Counsel Joyce A. Rechtschaffen, Minority Staff Director and Counsel Darla D. Cassell, Administrive Clerk ------ SUBCOMMITTEE ON OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND THE DISTRICT OF COLUMBIA GEORGE V. VOINOVICH, Ohio, Chairman WILLIAM V. ROTH, Jr., Delaware RICHARD J. DURBIN, Illinois JUDD GREGG, New Hampshire ROBERT G. TORRICELLI, New Jersey Kristine I. Simmons, Staff Director Marianne Clifford Upton, Minority Staff Director and Chief Counsel Julie L. Vincent, Chief Clerk C O N T E N T S ------ Opening statements: Page Senator Voinovich............................................ 1 Senator Durbin............................................... 2 WITNESSES Wednesday, August 4, 1999 Jane E. Henney, M.D., Commissioner, Food and Drug Administration, U.S. Department of Health and Human Services................... 9 Catherine E. Woteki, Ph.D., R.D., Under Secretary for Food Safety, U.S. Department of Agriculture......................... 11 Lawrence J. Dyckman, Director, Food and Agriculture Issues, U.S. General Accounting Office, accompanied by Keith Oleson, Assistant Director, Food and Agriculture Issues, U.S. General Accounting Office.............................................. 13 Carol Tucker Foreman, Distinguished Fellow and Director, Food Policy Institute, Consumer Federal of America.................. 16 Nancy Donley, President, S.T.O.P., Safe Tables Our Priority...... 25 Caroline Smith DeWaal, Director, Food Safety Programs, Center for Science in the Public Interest................................. 28 Rhona Applebaum, Ph.D., Executive Vice President, for Scientific and Regulatory Affairs, National Food Processors Association... 30 Stacey Zawel, Ph.D., Vice President for Scientific and Regulatory Policy, Grocery Manufacturers of America....................... 31 Alphabetical List of Witnesses Applebaum, Rhona: Testimony.................................................... 30 Prepared statement........................................... 119 DeWaal, Caroline Smith: Testimony.................................................... 28 Prepared statement........................................... 96 Donley, Nancy: Testimony.................................................... 25 Prepared statement........................................... 92 Dyckman, Lawrence J.: Testimony.................................................... 13 Prepared statement........................................... 68 Henney, Dr. Jane E.: Testimony.................................................... 9 Combined prepared statement with attachments................. 49 Foreman, Carol Tucker: Testimony.................................................... 16 Prepared statement........................................... 81 Woteki, Catherine E.: Testimony.................................................... 11 Combined prepared statement with attachments................. 49 Zawel, Stacey: Testimony.................................................... 31 Prepared statement........................................... 124 APPENDIX Charts submitted by Senator Durbin............................... 41 Letter to Senator Durbin, from Donna E. Shalala, Secretary of Health and Human Services; Dan Glickman, Secretary of Agriculture; and Neal Lane, Assistant to the President for Science and Technology......................................... 130 Sanford A. Miller, Ph.D., Professor and Dean, Graduate School of Biomedical Sciences, University of Texas Health Science Center at San Antonio, prepared statement............................. 131 Questions and responses from Catherine E. Woteki, Ph.D., R.D., Under Secretary, Food Safety, Department of Agriculture........ 135 Questions and responses from Caroline Smith DeWaal, Director, Food Safety, Center for Science in the Public Interests, with attachments A thru F........................................... 141 Questions and responses from Melinda K. Plaisier, Associate Commissioner for Legislature, Department of Health & Human Services....................................................... 161 ``OVERLAP AND DUPLICATION IN THE FEDERAL FOOD SAFETY SYSTEM'' ---------- WEDNESDAY, AUGUST 4, 1999 U.S. Senate, Oversight of Government Management, Restructuring, and the District of Columbia Subcommittee, of the Committee on Governmental Affairs, Washington, DC. The Subcommittee met, pursuant to notice, at 10:40 a.m., in room 342, Dirksen Senate Office Building, Hon. George Voinovich, Chairman of the Subcommittee, presiding. Present Senators Voinovich and Durbin. OPENING STATEMENT OF SENATOR VOINOVICH Senator Voinovich. The hearing will come to order. Good morning and thank you for coming. Today the Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia, holds the second hearing on the issue of food safety entitled, ``Overlap and Duplication in the Federal Food Safety System.'' The first hearing, which was held on July 1, examined Federal oversight of egg safety as a case study of the fragmentation and overlap in Federal food safety responsibilities. This hearing will not focus on a single food area, but rather it will examine the organization of all Federal food safety responsibilities. I must say that a recent event in my life has influenced my thoughts on this issue. Last week, my wife came down with food poisoning and I became very sick. She had a couple of days of tests in the hospital and during the incident I kept wondering how did she get it and how could it have been avoided. I suspect that the source of the problem was not on the farm but rather in the handling of the food at the retail level. I am not saying that Federal inspectors should run out to all these retail establishments and do something about it. That is a county responsibility in our State. Nevertheless, that experience that I had really brought home to me--when you have to call emergency medical services at 1:30 in the morning and you have a very sick wife, you really understand the problem-- much more so than someone that has not had that experience. We have over 35 different laws that govern food safety policy, some of which are over 100 years old. Currently 10 different agencies, within four cabinet-level departments, as well as two independent agencies have some responsibility for food safety. The combined food safety budget is over $1 billion a year. The Subcommittee will examine this issue with two questions in mind. First, if the Federal Government were to create a food safety system from scratch, start out right from the beginning, would it resemble the current system that we have? And, second, is this the best and most logical organization for Federal food safety agencies? In addition, the Subcommittee will discuss S. 1281, the Safe Food Act of 1999, introduced by Senator Durbin that has been referred to our Committee. According to the General Accounting Office, whose work on this issue has spanned more than two decades and included 49 reports, food safety is one of 33 program areas in the Federal Government in which there is substantial fragmentation and overlap. The longer I am here, I see what is going on in this area is going on all over the Federal Government. As I mentioned earlier, four Federal departments, Agriculture, Commerce, Health and Human Services, and Treasury, as well as the Environmental Protection Agency and the Federal Trade Commission, have a role in food safety. Depending upon the department or agency, the Federal Government has vastly different approaches to food safety. For example, the Food Safety and Inspection Services in the USDA conducts continuous inspections at meat, poultry and egg processing plants around the country. The Food and Drug Administration, which is in Health and Human Services, on the other hand, conducts inspections of food processing plants within its jurisdiction once every 10 years, on average. In addition, several analysts of Federal food safety policy argue that some of our efforts lack a scientific basis and should be focused on the most severe food-borne threats to human health, specifically micro-bio contamination. I view this issue primarily as one of government management, and am most interested in learning how and why there are 12 different agencies involved in the oversight of food safety and what we can do to improve the current system. I am here today to listen. I had not studied this issue in depth before learning of Senator Durbin's interest in this legislation. However, I do look forward to learning from our witnesses this morning whether there is any justification for the fragmentation which seems to exist and whether we can do better. I would now like to yield to the Ranking Minority Member of this Subcommittee, Senator Durbin. OPENING STATEMENT OF SENATOR DURBIN Senator Durbin. Chairman Voinovich, thank you for this hearing. I appreciate it very much and it is a topic which is near and dear to my heart and your family experience this last week, which you told me about just a few days ago, is repeated about 81 million times each year in the United States. And unfortunately, for 9,000 of those cases, it is fatal. Thank God it did not happen to your family nor has it happened to mine, but we will hear testimony today from a family where it has happened. It is a serious issue. And it is one that, frankly, Congress really has no excuse to avoid any longer. In 1977, this same Committee issued a report about fragmentation in the food safety jurisdiction of the Federal Government. Twenty-two years ago we were dealing with this and saying that we have to do something about it. And, sadly, we have done very little. I want to say at the outset that the people who are testifying today, Dr. Henney, Dr. Woteki, folks from the General Accounting Office, as well as Carol Tucker Foreman, I believe are all sincere professional individuals who really have the public interest in mind. But I have to say that some of the best medical professionals when they get into the Federal bureaucracy kind of lose sight of the goal here. It all becomes a turf battle, a jurisdictional dispute and the same thing happens on Capitol Hill. Committee chairmen, everybody has got a piece of the action. Nobody wants to give it up. You go downtown, the USDA is afraid they are going to lose their employees if this goes to a single food agency. The FDA has the same fear and so do many other agencies. And that competition has created gridlock and has created utter nonsense when it comes to the responsibility for food safety in America. We have on this table before you here some examples of the different jurisdiction for foods. And it is incredible to look at one pizza and decide that is the USDA's responsibility, another pizza is the FDA's and the list goes on and on. And if you are out--I am kind of picking on Italian foods today, I do not mean to--but if you go out to the food store, and you buy beef ravioli and cheese ravioli, you have just bought two products that have different jurisdictions under the Federal Government. Beef ravioli, Department of Agriculture, of course; cheese ravioli, why, of course, the Food and Drug Administration. You would not want the USDA to look at cheese ravioli, would you? Or you would not want the FDA to look at beef ravioli. And that just, I think, illustrates what has happened here. Let me use one that comes from a little lighter vein and perhaps will betray my age a little bit. Forgive this, it may not be the best graphic, but one of my favorite routines on Saturday Night Live was Father Guido Sarducci, who had a routine entitled, ``How Many Popes in the Pizza?'' Well, we decided to take a look after the GAO report to find out how many different Federal agencies are responsible for making sure that the pizza that comes to your table is safe. You will notice that EPA, Agriculture Marketing Service, FDA, Animal Plant Health Inspection Safety, the Grain Inspection Safety Agency, and the Food Safety Inspection Service, all have a hand in inspecting this pizza on its way to our tables. Six different Federal agencies. How many bureaucrats in the pizza, I would ask Father Sarducci. And that is what it boils down to. And what are we going to do about it? Frankly, we have not done enough. We have talked about it, we have studied it, we have issued all sorts of pious statements about how we have to get this under control and I am just not pleased with where we are today. First, let me tell you why this is important. We do have the safest food supply in the world but it can be a lot safer. We do have a good food safety inspection system but it can be less bureaucratic, it can be more efficient, it can be driven by science and not by politics. And I think that is what every consumer wants. In addition to that, we have to concede that we are entering into an era where food safety is a big ticket item, not just in terms of life and death for Americans, but also in terms of commerce. Do you know what is going on in Europe today? We are in pitched battle in Europe today about the safety of food. And as a result, we are finding many of our exports from the United States that are being excluded, the Europeans will not buy them. They say they are dangerous. And the reason? Frankly, there is no FDA or U.S. Department of Agriculture in the European Union that people trust. And, as a result, it takes nothing to panic the consumers in Europe away from products or toward products. It really argues, from my point of view, for us to have a science-based, coordinated, single agency effort here. We have to be able to defend the products that we sell to American families and the products we export around the world. And as long as you are dealing with six different agencies when it comes to pizza, you can see how we are fragmented and moving in so many different directions. So, from the viewpoint of the 21st Century and the demands consumers will have worldwide for trust in the food that they eat, I think this concept is long overdue. Let me show you a couple of other charts that illustrate some of the history of this.\1\ I will go through them very quickly. We have had a series of GAO study reports. I am happy that GAO is here today. This has been an ongoing effort by the GAO. That just shows 5 or 6 years. All of them concluding that a single food safety agency was the way to go to try to make some sense out of the nonsense of our current bureaucracy. --------------------------------------------------------------------------- \1\ The charts referred to appears in the Appendix on page 41. --------------------------------------------------------------------------- The Governmental Affairs Committee, as I said, in 1977 and since has said repeatedly that dividing responsibility for food safety is not smart and we should put it in a single agency. The different reports by Vice President Gore on the same thing--this is from the National Academy of Sciences--I am going to be referring to this throughout the day because the industry people for some reason jumped on this report in August 1998 and said, proof positive, the White House is opposed to a single food safety agency. And, yet, if you will look through it, they talk about a single voice, a single unified agency, one official. I really wish the people who are here representing the business community would not be so frightened by the idea of some change. This change could be for the better. You could have more confidence when it comes to consumers buying your product and you could have better results when you try to export overseas. But there has been this wall of resistance from the private sector side which just does not make sense. We are more than happy to work with you. We are not trying to make your life any more difficult. We are trying to make it more sensible. If you make pizza and the USDA inspector shows up every day and the FDA inspector shows up every 3 years, 5 years or 10 years, how does that help you as a businessperson to make your plans and to go about your business? And I hope the private sector will be a little more open-minded as we get into this. We have asked the former food officials who have been involved in this from FDA as well as different agencies, and Carol Tucker Foreman, of course, is quoted here, and we will hear from her in person. Dr. Kessler said it is ironic that the National Government deals with food safety issues in such a haphazard, inconsistent manner. And he goes on to say that we need a single agency with one mission and one consistent set of food safety goals. After the folks leave government they tell us this. Sometimes, while they are there, but after they leave government they look back and say, why did I not do something about this tangled mess of Federal agencies stumbling over one another with the responsibility for food safety? Well, I thank the Chairman for bringing this together today and a lot more will come out during the course of the hearing. I am looking forward to the testimony. Thank you. The prepared statement of Senator Durbin follows: PREPARED STATEMENT OF SENATOR DURBIN Mr. Chairman, I would like to thank you for calling this hearing on an issue of importance to every American virtually every time they eat. I appreciate your willingness to follow up on our hearing regarding egg safety with this more comprehensive look at the fragmentation in our Nation's food safety system. This is not the first time this committee has studied the issue of food safety. Consider the following quote from a study produced by this committee in 1977: Divided responsibility between the Department of Agriculture and the Food and Drug Administration for food regulation has created a regulatory program which is often duplicative, sometimes contradictory, undeniably costly, and unduly complex. The current jurisdiction overlap has resulted in redundant inspections of the same plant, the shifting of responsibility of particular food items at various stages of production, and inconsistent food labeling policy. The recurrent problems of overlap, duplication, and concurrent jurisdiction are addressed by UDSA and FDA officials on an ad hoc case-by-case basis. There is currently no systematic or rational overall approach to Federal food regulation. Committee on Governmental Affairs, United States Senate Study on Federal Regulation, Volume V, Regulatory Organization December 21, 1977, p. xv. Mr. Chairman, today this subcommittee revisits this issue and I am sad to report that the findings, reported by the Committee on Governmental Affairs over 20 years ago, remain an accurate description of the Federal food safety system of today. But we can change this situation. We currently have before us the Safe Food Act of 1999 (S. 1281)--a piece of legislation that can fundamentally set the course for a food safety system that is efficient, effective, based in science, and has the promise of maintaining the confidence of the consuming public. Make no mistake, our country has been blessed with one of the safest and most abundant food supplies in the world. However, we can do better. Foodborne illness is a significant problem. While food may never be completely free of risk, we must strive to make our food as safe as possible. Americans at every level--Federal, State, and local government, industry, and the consuming public--share this responsibility. The safety of our Nation's food supply is facing tremendous pressures with regard to emerging pathogens, an aging population with a growing number of people at high risk for foodborne illnesses, broader changes in food distribution patterns, an increasing volume of food imports, and changing consumption patterns. The General Accounting Office (GAO) estimates that as many as 81 million people will suffer food poisoning this year and more than 9,000 will die. Children and the elderly are especially vulnerable. In terms of medical costs and productivity losses, foodborne illness costs the Nation up to $37 billion annually. The situation is not likely to improve without decisive action. The Department of Health and Human Services predicts that foodborne illnesses and deaths will increase 10- 15 percent over the next decade. In 1997, a Princeton Research survey found that 44 percent of Americans believe the food supply in this country is less safe than it was 10 years ago. American consumers spend more than $617 billion annually on food, of which about $511 billion is spent on foods grown on U.S. farms. Our ability to assure the safety of our food and to react rapidly to potential threats to food safety is critical not only for public health, but also for the vitality of both domestic and rural economies and international trade. Consumer confidence is important--just look what's happening in Europe, where Belgium has become embroiled in a dioxin crisis. Days before the national elections, poultry, eggs, pork, beef, and dairy products were withdrawn from supermarket shelves. Butcher shops closed and livestock farms were quarantined. Since then, countries worldwide have restricted imports of eggs, chickens, and pork from the European Union. Public outrage in Belgium over the dioxin scandal led to a disastrous showing by the ruling party in the national and European elections on June 14, and the government was forced to resign. Food safety concerns and fears are global. Part of the controversy in Europe is the failure of government to win the confidence of the consumers. People lose confidence and panic unnecessarily when their government can't step up to its responsibilities. From ``mad cow'' disease to dioxin, we cannot afford to ignore these lessons regarding government's role in effectively and efficiently managing food safety. A credible Federal food safety system reassures consumers and makes our products more acceptable--here and abroad. Today, food moves through a global marketplace. This was not the case in the early 1900's when the first Federal food safety agencies were created. Throughout this century, Congress responded by adding layer upon layer--agency upon agency--to answer the pressing food safety needs of the day. That's how the Federal food safety system got to the point where it is today. And again as we face increasing pressures on food safety, the Federal Government must respond. But we must respond not only to these pressures but also to the very fragmented nature of the Federal food safety structure. Fragmentation of our food safety system is a burden that must be changed to protect the public health. Currently, there are at least 12 different Federal agencies and 35 different laws governing food safety, and 28 House and Senate subcommittees with food safety oversight. With overlapping jurisdictions, Federal agencies often lack accountability on food safety-related issues. In a hearing last month, this subcommittee examined the way in which this fragmentation negatively affected the safety of the Nation's egg supply. Salmonella Enteritidis (SE) has been recognized as a cause of food-borne illness associated with mishandled or undercooked eggs since the mid-1980s. In 1997, SE may have caused about 300,000 illnesses, resulting in 230 deaths. Just last month, an International House of Pancakes restaurant in Richmond, Virginia was closed after 92 people contracted salmonella from eating eggs there. Seven people were hospitalized. Yet in over a decade since this problem first surfaced, the four Federal agencies with egg safety responsibility still have not implemented an effective comprehensive SE-prevention program. At last month's hearing, the General Accounting Office (GAO) released its report, U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety, which described the gaps, inconsistencies, and inefficiencies in the current egg safety system. The General Accounting Office has been unequivocal in its recommendation for consolidation of Federal food safety programs. GAO's April 1998 report states that ``[s]ince 1992, we have frequently reported on the fragmented and inconsistent organization of food safety responsibilities in the Federal Government.'' In a May 25, 1994, report, GAO stated that its ``estimony is based on over 60 reports and studies issued over the last 25 years by GAO, agency Inspectors General, and others.'' The Appendix to the 1994 GAO report listed: 49 reports since 1977, 9 USDA Office of Inspector General reports since 1986, 1 HHS Office of Inspector General report in 1991, and 15 reports and studies by Congress, scientific organizations, and others since 1981. Again, earlier this year, GAO in its 21-volume report on government waste, pointed to the lack of coordination of the Federal food safety efforts as an example. ``So many cooks are spoiling the broth,'' said the GAO while highlighting the absurdity of having one Federal agency inspecting frozen meat pizza and another inspecting frozen cheese pizza. But GAO is not the only agency calling for consolidation. Last August, the National Academy of Sciences (NAS) released a report recommending the establishment of a ``unified and central framework for managing Federal food safety programs,'' arguing that it should be ``one that is headed by a single official and which has the responsibility and control of resources for all Federal food safety activities. . .'' That report further states, ``Many members of the committee are of the view that the most viable means of achieving these goals would be to create a single, unified agency headed by a single administrator. . .'' I agree with this conclusion; S. 1281--the Safe Food Act of 1999--will do just that. The administration has stepped forward on the issue of food safety--the President's Food Safety Initiatives and the President's Council on Food Safety have focused efforts to track and prevent microbial foodborne illnesses. I commend President Clinton and Secretaries Glickman and Shalala for their commitment to improving our Nation's food safety and inspection systems. I also acknowledge the long list of accomplishments by our agencies, represented today by Dr. Catherine Woteki, Under Secretary for Food Safety at the U.S. Department of Agriculture and Dr. Jane Henney, Commissioner of the Food and Drug Administration in the U.S. Department of Health and Human Services. I commend the dedication of the professionals in our Federal agencies who are committed to improving the safety of our food supply. This administration has produced many food safety successes through a dedicated focus to coordinate agencies' efforts. Some suggest that this recent commitment to enhanced coordination is all that is needed. But this isn't the first time that coordination has been suggested. Again I refer to the 1977 Senate Governmental Affairs Committee report which says, ``While we support the recent efforts of FDA and USDA to improve coordination between the agencies, periodic meetings will not be enough to overcome the problems outlined above.'' Coordination alone is not enough, as the NAS committee reports, ``[T]he structure should also have a firm foundation in statute and thus not be temporary and easily changed by political agendas or executive directives.'' We must not retreat from recent food safety advances that have been made. We must provide the means to sustain this progress. Dr. Sanford A. Miller, a former Director of the FDA Center for Food Safety and Applied Nutrition (1978 to 1987) who also served on the NAS study committee, was unfortunately unable to appear to testify today. His written statement is submitted for the record. Dr. Miller sums it up well in saying, ``Each agency operates under a different mandate, governed by different laws and answering to different constituencies and traditions. To ask them to voluntarily ignore this history is naive. There needs to be a permanent structure focused on food safety to meet the enduring needs of the American people.'' Earlier this year in response to the NAS report, even the President's Council on Food Safety stated its support for the NAS recommendation calling for a new statute that establishes a unified framework for food safety programs with a single official with control over all Federal food safety resources. As directed by the President, the Council is currently developing a strategic plan. Three weeks ago, the council hosted a day-long meeting to gather public comment as part of that process. Food Chemical News reported that a ``number of participants suggested that a single food safety agency would solve many of the problems by improving coordination and resolving uneven funding across agencies that makes it difficult to target resources based on food safety risks.'' I encourage the Council to seriously consider those comments. An independent single food safety agency is needed to replace the current, fragmented system. The Safe Food Act of 1999 would combine the functions of USDA's Food Safety and Inspection Service, FDA's Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine, the Department of Commerce's Seafood Inspection Program, and the food safety functions of other Federal agencies. This new, independent agency would be funded with the combined budgets from these consolidated agencies. With overlapping jurisdictions, Federal agencies many times lack accountability on food safety-related issues. There are simply too many cooks in the kitchen. A single, independent agency would help focus our policy and improve enforcement of food safety and inspection laws. It's time to move forward. Let us stop using multiple Federal agencies to inspect pizza. Instead let us ``deliver'' what makes sense--a single, independent food safety agency. A single, independent agency with uniform food safety standards and regulations based on food hazards would provide an easier framework for implementing U.S. standards in an international context. When our own agencies don't have uniform safety and inspection standards for all potentially hazardous foods, the establishment of uniform international standards is next to impossible. Research also could be better coordinated within a single agency than among multiple programs. Currently, Federal funding for food safety research is spread over at least 20 Federal agencies, and coordination among those agencies is ad hoc at best. New technologies to improve food safety could be approved more rapidly with one food safety agency. Currently, food safety technologies must go through multiple agencies for approval, often adding years of delay. In this era of limited budgets, it is our responsibility to modernize and streamline the food safety system. The U.S. simply cannot afford to continue operating multiple systems. This is not about more regulation, a super agency, or increased bureaucracy, it's about common sense and more effective marshaling of our existing Federal resources. With the incidence of food recalls on the rise, it is important to move beyond short-term solutions to major food safety problems. A single, independent food safety and inspection agency could more easily work toward long-term solutions to the frustrating and potentially life-threatening food safety issues we face . Some individuals have argued that we don't need a whole new government bureaucracy, that moving boxes around on an organizational chart won't make food safer, and that if the system isn't broken then it doesn't need to be fixed. But what they don't appreciate is that the current fragmented system makes it impossible to apply resources to the areas of greatest need. The current fragmented system makes it difficult for the agencies to be held accountable. For example, the current fragmented system places food safety efforts in conflict with the mission for agricultural market promotion. A system that determines which agency inspects which plant based on whether the plant produces an open-faced sandwich rather than a traditional one is one which, if not broken, is certainly illogical. A single, independent food safety agency will not have the burdens of our current fragmented system. Consolidation of food safety functions in a single, independent agency will preserve the expertise currently in our agencies in a manner that will promote more efficient and effective government. One agency instead of 12 or more handling food safety is a reduction in bureaucracy and red tape. Mr. Chairman, we have before this subcommittee a bill, S. 1281, which can bring the various agencies together to eliminate the overlap and confusion that have at times, unfortunately, characterized our food safety efforts. We need action, not simply reaction. Our current fragmented food safety structure is not the best that we are capable of having and it certainly is not the most logically designed system. Members of the Senate Governmental Affairs Committee of 1977 understood the problem, and they were correct when they reported, ``Responsibility for Federal food regulation, which is currently divided, should be assigned to a single agency.'' I hope we can finally achieve that goal. I welcome today's witnesses and the insights they will share, and I look forward to working with you toward a more effective and less fragmented food safety system. Senator Voinovich. Thank you, Senator Durbin. I would like to now introduce the first panel of witnesses. Representing the administration are Dr. Jane Henney, who is the Commissioner of the Food and Drug Administration, U.S. Department of Health and Human Services; and Dr. Catherine Woteki, Under Secretary of Food Safety, U.S. Department of Agriculture. Lawrence Dyckman is the Director of Food and Agricultural Issues at U.S. General Accounting Office, and he is accompanied by Keith Oleson, Assistant Director, Food and Agricultural Issues. And rounding out the panel is Carol Tucker Foreman, who is the Distinguished Fellow and Director of the Food Policy Institute at the Consumer Federation of America. We thank all of you for coming this morning. It is the custom of this Subcommittee to swear in all witnesses. Therefore, I would ask you to stand and raise your right hands, and I would also ask the witnesses that will be on the second panel to stand, and I will swear all of you in. [Witnesses sworn.] Senator Voinovich. We will now call on our first witness, Dr. Henney. We are anxious to hear what you have to say. TESTIMONY OF JANE E. HENNEY, M.D.,\1\ COMMISSIONER, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. Henney. Thank you. Mr. Chairman, let me express on behalf of all of us on the panel we are very sorry to hear about your wife but glad that she has recovered well. --------------------------------------------------------------------------- \1\ The combined prepared statement of Dr. Henney and Ms. Woteki appears in the Appendix on page 49. --------------------------------------------------------------------------- Mr. Chairman, and Members of the Subcommittee, we are pleased to be here this morning to discuss one of the administration's highest priorities, protecting our Nation's food supply. I am Dr. Jane Henney, the Commissioner of Food and Drugs at FDA and I am joined by Dr. Cathy Woteki, Under Secretary for Food Safety at USDA. We appreciate your continued interest in ensuring the safety of our Nation's food supply and look forward to a full discussion of the issues you are raising today. Although the American food supply is among the safest in the world, too many cases of foodborne illness occur in the United States each year. Mr. Chairman, today Dr. Woteki and I will describe many of the achievements that have happened in the past several years but we will also look at the work that remains. Today's food safety challenges are very complex. First, Americans are eating a greater variety of foods, particularly seafood, poultry, fresh fruit, and vegetables that are available throughout the year. Second, Americans are eating more of their meals that are prepared away from home. Third, nearly a quarter of the U.S. population--the very young, the old, the immune-compromised--is at higher risk for foodborne illness. And perhaps the most important element in our changing world is the emergence of new and more virulent foodborne pathogens. Since 1942, the number of known foodborne pathogens has increased more than five-fold. Until the first decade of this century, the regulation of food safety was primarily the responsibility of State and local officials. The Pure Food and Drugs Act and the Meat Inspection Act were both passed by Congress in 1906. From the beginning, nearly 100 years ago, these laws focused on different areas of the food supply and each of them took a different approach to the food safety issues because of different problems that were present at that time. The Pure Food and Drugs Act placed the initial responsibility for producing safe and wholesome food squarely on the shoulders of the food industry. The Federal Government's job, in effect, was to police the industry. Unlike FDA's law, the USDA's Meat Inspection Act requires continual government inspections in the slaughterhouse. These laws form the foundation of the food safety system today. Under the current structure, FDA has jurisdiction over 78 percent of the Nation's food supply--all domestic and imported foods except for meat, poultry and egg products. FDA has jurisdiction where food is produced, processed, packaged, stored or sold. The USDA's Food Safety and Inspections Service has regulatory and inspection responsibility for meat, poultry and egg products. And although the guiding statutes of the USDA and FDA approach food safety differently, today each agency relies on sound science and risk-based approaches to food safety. As our written testimony explains our efforts are strengthened by close working relationships with other Federal agencies such as the Centers for Disease Control and Prevention, the Environmental Protection Agency, and our State and local partners. Together we promote food safety and prevent foodborne illness and food hazards through coordinated and integrated activities. Food safety has been a high priority for this administration. This year for the third consecutive year, the administration has strongly supported the multi-agency effort to protect the health of the American public by improving the safety of the Nation's food supply. This process began with the May 1997 report to the President entitled, ``Food Safety: From Farm To Table,'' a national food safety initiative. This report contained recommendations that are both comprehensive and ambitious, and implementation of the report has depended upon a food safety system that is integrated and interdependent. The report has led to a very needed shift in our collective attention and resources toward the growing problem of microbial contamination of food. In just 2 years, the administration has undertaken the vast majority of the report's recommendations. Last August the President established the Council on Food Safety, whose goal is to make the food supply even safer through a seamless science-based food safety system supported by well coordinated surveillance, standards, inspection, enforcement, research, risk assessment, education, and strategic planning. Dr. Woteki will be discussing this strategic plan. I would like to just briefly highlight a few of the administration's food safety successes. One, in July 1995, HHS and USDA began a collaborative project called FoodNet under this initiative. It provides a strong network for responding to new and emerging foodborne illnesses, for monitoring the burden of foodborne illness, and identifying the source of specific foodborne diseases. PulseNet was developed by the CDC and it is now joined by a collaborative effort with HHS and USDA, as well as several States, that enables a national network of public health laboratories to perform DNA fingerprinting on bacteria that may be foodborne. PulseNet permits rapid and accurate detection of foodborne illness outbreaks. The National Antibiotic Resistance Monitoring Program was established in 1996 as a strong inter-agency cooperative initiative. There are more achievements than I can highlight in this short time. I want to leave time for Dr. Woteki to go through our strategic planning process and specifically some highlights of our successes in the area of research. Thank you. Senator Durbin [presiding]. Thank you very much. Dr. Woteki. TESTIMONY OF CATHERINE E. WOTEKI,\1\ Ph.D., UNDER SECRETARY FOR FOOD SAFETY, U.S. DEPARTMENT OF AGRICULTURE Ms. Woteki. Thank you very much. --------------------------------------------------------------------------- \1\ The combined prepared statement of Dr. Henney and Ms. Woteki appears in the Appendix on page 49. --------------------------------------------------------------------------- Mr. Chairman, sorry you have to leave. Senator Durbin, I am pleased to be here as well, and I would like to echo the comment that Dr. Henney made about the commitments that we have within the administration to work together at all levels of government to strengthen our national food safety system. I have also brought with me today a couple of charts, as well, and I would like to draw your attention to the one that is over here on the side. This is actually taken from the same report that you cited, that the National Academy of Sciences issued last year, in which they describe the attributes of an effective food safety system and this diagram tries to capture all of those elements. I think what is important is to focus on the center oval in that diagram. Really the important focus of our food safety system and any other effective food safety system is on public health and improving human well-being. In addition, this chart illustrates that there are many different key players in the food safety system: The private sector, government, as well as consumers. And that they have independent functions but they are also interdependent in many ways. They are all dependent on a science-based approach that depends on research and the provision of education and important information that each of these sectors needs in order to fulfill its roles and functions. I think the chart also illustrates the fact that these groups have to work together through partnerships in order to achieve that central focus and goal: Improving public health. Now, we believe, within the administration, that the activities that we have ongoing do meet these attributes of an effective food safety system. And, as Dr. Henney indicated in her testimony, we are trying to put our testimony together to actually highlight the accomplishments over the last several years with respect to furthering these attributes of an effective food safety system. I would like to point out a second chart that we have brought along with us. It illustrates the logo for the Fight Bac campaign, which has been a very effective food safety education program that also has been science-based and has also been the result of a very effective partnership among the private sector, consumer groups, Federal agencies, and other organizations. Now, before I continue where Dr. Henney left off, I would like to just briefly talk about the role of the Office of Food Safety within the Department of Agriculture because it is a new office that was created in the 1994 reorganization. We believe that the creation of this office has effectively laid to rest the complaints that have arisen in the past about the potential for conflict of interest within the department with respect to food safety. By separating the regulatory from the marketing functions, we believe that we have successfully put those complaints to rest. The legislation that authorized the reorganization requires that the Office of Food Safety be filled by an individual who has a specific and proven public health or food safety background. And these changes have very substantially enhanced USDA's public health focus and also, I believe, fortified food safety's presence within the department's broad mission. The Food Safety and Inspection Service does report to the Office of Food Safety. As you know, we have the responsibility for the inspection of meat, poultry and egg products sold in interstate commerce, and also for the inspection of imported products. The agency has approximately 7,000 Federal inspectors that are located in 6,000 plants and, subject to the authorizing legislation for the agency, conducts continuous inspections. This amounts to approximately 8 billion poultry, 135 million livestock, as well as inspections that are conducted in processing plants. Now, our testimony focuses on five additional attributes that the academy report listed for an effective food safety system. And I would like to just briefly describe them now. The first is research. And since we have a science-based approach to food safety, we have continued to emphasize and even given more emphasis under the President's Food Safety initiative to the importance of R&D. And certainly through the appropriations, Congress has very substantially increased the amount of funding that is going to food safety research. We also believe that these R&D activities are paying off in the development of new technologies that can be implemented farm to table to improve food safety. Another attribute that the academy report describes is effective regulation. And in the case of both the Food and Drug Administration and the Food Safety and Inspection Service, we are implementing new science- based, hazard analysis and critical control program approaches to improve food safety. So, we believe that we are making very substantial strides in effective regulation. There are also independent reviews conducted both of the seafood inspection as well as of the meat and poultry HACCP implementations that are demonstrating the effectiveness of those programs. New technologies are dependent on the science. And we are seeing the adoption of new technologies from steam pasteurization to anti-microbial rinses to the use of competitive exclusion products, to improve food safety, again, at the farm level as well as at the processing level. We are also working on education and information programs to improve the amount and quality of science-based information that is available to the public as well as to all who are responsible for food safety in that continuum from farm to table. I mentioned the Fight Bac campaign at the beginning of my remarks. Clearly, we are also taking other steps through consumer labeling approaches and other information provision approaches. Last, we recognize the importance of partnerships with State and local governments as well as other partners throughout the food system. Both FDA and FSIS historically have had very strong partnerships with the States. Two recent examples are the Seafood HACCP Alliance in which States worked closely with FDA and the industry in the development of that new program and USDA's continued work with the 25 States that operate inspection programs. Now, where do we go from here? Dr. Henney referred to the work of the President's Food Safety Council and of the Task Force that both Dr. Henney and I co-chair that is emphasizing the development of a strategic plan and budget to develop further improvements in our approaches to assure the public the safety of their food. Now, to draft the strategic plan, the Council established the Task Force that Dr. Henney and I co-chair. We have through that Task Force, developed a draft set of goals and objectives. We have shared them with stakeholders in a meeting that was held last month to solicit their views and opinions and we have scheduled a second public meeting for October 1999, in just a couple of months. We will be providing a copy of a draft plan to the public early in the year 2000 and our final report is due to the President in July of next year. Now, we firmly believe that a seamless, science-based food safety system is critical to ensuring the safety of our food supply and in protecting public health. How we get there should be carefully thought through with all of our partners and stakeholders. And I would like to assure you that we are approaching this effort very seriously and, we think, as expediently as we can and building in ample opportunities for consultation with stakeholders and partners. And we are considering the full range of options that are available to us and the recommendations of the academy. I very much thank you for the opportunity to appear before you and to discuss our food safety programs and we are certainly looking forward to working with you in the future. Senator Durbin. Thank you. I would like to thank you and Mr. Dyckman as well as Mr. Oleson, from the General Accounting Office, for the work that they have done on this issue. They have testified before and I welcome their return to the Subcommittee. Mr. Dyckman. TESTIMONY OF LAWRENCE J. DYCKMAN,\1\ DIRECTOR, FOOD AND AGRICULTURE ISSUES, U.S. GENERAL ACCOUNTING OFFICE; ACCOMPANIED BY KEITH OLESON, ASSISTANT DIRECTOR, FOOD AND AGRICULTURE ISSUES, U.S. GENERAL ACCOUNTING OFFICE Mr. Dyckman. It is always nice to be before this Subcommittee, Senator Durbin. --------------------------------------------------------------------------- \1\ The prepared statement of Mr. Dyckman appears in the Appendix on page 68. --------------------------------------------------------------------------- Much of what I have to say you have summarized so, if you will bear with me repeating your statements because I think we agree on many points. Millions of people become ill and thousands die each year from eating unsafe food. As we have stated in previous reports and testimonies, fundamental changes to the food safety system would minimize the risk of foodborne illnesses. These changes include moving to a uniform risk-based inspection system, administered by a single agency. My testimony today provides another view of our work on the problems resulting from the current fragmented food safety system and discusses our views on where in the Federal Government food safety responsibilities should reside. As the chart up there shows and as you have already described, the Federal food safety system is very complex. Senator Durbin. I want to give you credit, the GAO credit for inspiring our pizza. That was your chart that did that. [Laughter.] Mr. Dyckman. Yes. I actually liked your props a little better than ours. We do have a chart. There are 12 agencies involved with food safety. Thirty-five different laws ensuring the safety of cheese pizzas and meat pizzas, involves a half a dozen agencies. Currently, food safety laws not only assign specific food commodities to particular agencies but also provide agencies with different authorities and responsibilities that reflect significantly different regulatory approaches. The following samples from our prior work show some of the problems we found in reviewing the Nation's fragmented food safety system. Federal agencies are not using their inspection resources efficiently because the frequency of inspection is based on the agency's regulatory approach. Some foods and establishments may be receiving too much attention while others not enough. For example, USDA inspects meat and poultry plants, as we have said, at least daily; while FDA inspects firms that process foods with similar risks such as rabbit, venison, buffalo, and quail, on average, once a decade. Senator Durbin. Let me stop you, Mr. Dyckman, if I might for a moment. Going back to the illustration here of this cheese ravioli, the FDA responsibility, once in a decade they might come through the plant to look at this product? Mr. Dyckman. That is our understanding. Senator Durbin. And on the beef ravioli, a daily inspection? Mr. Dyckman. Yes. Additionally, responsibilities for the oversight of chemical residues in foods are fragmented among three Federal agencies: The FDA, USDA, and EPA. As a result, chemicals posing similar risks may be treated differently by the agencies because they operate under different laws and regulations. This permeates down to the State level as well. For instance, because States use different Federal agency methodologies for determining tolerance levels, fish considered safe to eat in one State, can swim to the waters of another State and thus are considered unsafe. Enforcement authorities granted to the agencies also differ significantly and obviously that is one of the underlying problems with this whole food safety mess or quagmire. For example, unlike FDA, USDA has authority to require food processors to register so that they can be inspected. USDA can also temporarily detain any suspect meat and poultry products. We have also done work on imported foods and found that regulation of that is inconsistent and unreliable. For meat and poultry imports, USDA, by statute, can and does shift most of the responsibility for ensuring product safety to the exporting country and that is where we think it should be. In contrast, FDA must rely primarily on widely discredited port-of-entry inspections which cover less than 2 percent of shipments entering the United States in 1997. Fragmented responsibilities also cause problems for the food industry because there has not always been a complete clear, unified communication about health risks associated with contaminated food products. So, how do we deal with all of these problems? Well, we believe the most effective solution is to consolidate food safety programs under a single agency with a uniform authority. It is not a new concept, it is not a difficult concept, and it is common sense. It was debated first in 1972 by the Congress with a proposed bill to transfer FDA's responsibilities, including its food safety activities to a new independent agency. We have discussed today that the National Academy of Sciences mirrored much of the recommendations in our prior work and concluded that the current fragmented Federal food safety structure is not well equipped to meet emerging challenges and recommended that the Congress establish by statute a unified and central framework for managing Federal food safety systems. And the important thing and one that I want to stress is they recommended a system that is headed by a single official, not by several officials. However, whether food safety responsibilities should be housed under an independent agency or an existing department is subject to debate. In this regard, I just want to point out that we reported recently on the experiences of four countries that have consolidated or in the process of consolidating their food safety responsibilities. Great Britain's and Ireland's efforts were responding to heightened public concerns about the safety of their food supplies and choose to consolidate responsibilities in the agencies that report to their ministers of health, because the public lost confidence in the agricultural ministries that had responsibilities for some food products. While Canada and Denmark were more concerned about program effectiveness, cost savings, efficiencies, and they have consolidated their activities in agencies that already had those responsibilities, basically the agencies that report to the ministers of Agriculture. But regardless of where a single agency is housed, what is most important in our opinion, is the adherence to four key principles. First, a clear commitment by the Federal Government to consumer protection. Second, a system that is founded on uniform laws that are risk-based. Third, adequate resources to carry out the system. Fourth, competent and aggressive administration of the laws by the responsible agency and effective oversight by the Congress. If I could just make one more point, Senator Durbin, the original question was if we were asked to redesign the food safety system, how would we do it? If we had to start from scratch, as we enter the 21st Century, we would never build the present bifurcated system. It would not make any sense. I do not think if you asked a 100 people to start from scratch would they come up with what we have now. People are working hard, with best intentions, they are doing a fairly good job at what they do. But it is not that well coordinated. It is not completely risk-based. Parts of it are, large parts of it are not. So, why should we be satisfied with it now? Why not transform it? Why not transform it into the type of system and into the type of activities that your legislation calls for? This completes our statement. And we would be happy to answer any questions. Senator Durbin. Thank you. Carol Tucker Foreman, thank you for being with us. TESTIMONY OF CAROL TUCKER FOREMAN,\1\ DISTINGUISHED FELLOW AND DIRECTOR, FOOD POLICY INSTITUTE, CONSUMER FEDERATION OF AMERICA Ms. Foreman. Thank you, Senator Durbin. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Foreman appears in the Appendix on page 81. --------------------------------------------------------------------------- I am Carol Tucker Foreman. From 1977 to 1981 I served as Assistant Secretary for Food and Consumer Services at the Department of Agriculture with responsibility for meat, poultry and egg products inspection. I am here today to provide the perspective of one who has tried to make this system work for the American people but is now freed from the institutional imperative to defend the status quo. Unlike the government witnesses, I can answer your question. If the Federal Government were to create a food safety system from scratch, would it resemble the current system? Is this the best and most logical organization for Federal food safety agencies? I think you know my answer to both of those questions would be an emphatic, no. Two years ago Congress provided the National Academy of Sciences funds to examine the Nation's food safety system and recommend ways to improve it. In ensuring safe food from production to consumption the committee recommended that Congress create a unified and central framework for managing Federal food safety programs headed by a single Federal official who has both the authority and control of resources necessary to manage food safety efforts. The committee also pointed out that ad hoc efforts--and I include in that the President's Food Safety Council--will not suffice to bring about the vast cultural changes and collaborative efforts needed to create an integrated system. The problems with the present system are obvious. It does not produce an acceptable level of public health protection. Eighty-one million cases of foodborne illness and 9,000 deaths each year from food poisoning are not marks of success. Second, the present food safety system does not use human or public resources well. In fiscal year 1998, FDA and FSIS spent just shy of $1 billion for food safety. USDA with the responsibility for only meat, poultry and eggs, got $746 million of that; FDA, with responsibility for all the other food products, got only $222 million. The fiscal year 1998 budget paid for 7,200 USDA inspectors, while FDA had only 250. That disparity may explain why a Center for Science in the Public Interest analysis of CDC data showed that food products inspected by FDA were implicated in more foodborne illness outbreaks than foods inspected by USDA. The present system depletes the energies and demeans the talents of committed public servants who spend way too much of their time bumping each other and jockeying for advantage. The Commissioner of the Food and Drug Administration, the Under Secretary and the administrator of FSIS spend hours negotiating who is going to sign a letter, whose language is going to be used, who is going to get to sit at the table and where they will sit? What a waste of public funds and public talent. In March 1999, President Clinton's Council on Food Safety committed to examining a unified system. The Council has not done that. The strategic plan does not say a word about it. It is gone. What a shocking lack of leadership. The Commissioner, the Under Secretary, and the trade associations, will testify here today, are going to urge you to ignore all the facts that have been laid out by the General Accounting Office. Trade associations and the government will argue that tinkering around the edges and a little more cooperation will do the job. With all due respect, that has been tried before. Fixing the present system by tinkering and nibbling is like trying to teach a pig to sing. It will not work, and the pig does not like it. Our system is broke. If we are serious about protecting the public health we need to fix it. Consolidating food safety in one agency with one budget, one leader and, ultimately, one authorizing statute is the only way to do that. A multitude of independent bodies, Congressional committees, the GAO, the National Academy of Science, and virtually all the public officials who have led these agencies and been asked about it after they have left government give you the same response I have. Senator Durbin. If I might interrupt for a second? The reason why the staffer is looking so nervous, as she is, is because I have 2 minutes left to vote. And I want to give you a chance to conclude. Are you near the end here? Ms. Foreman. I am. Senator Durbin. OK, fine, thank you. Ms. Foreman. The change can be accomplished in a phased manner that ensures an orderly transition. Talented and committed public servants can make this work if you tell them to make it work. They cannot make the present system work. The American people deserve a better, more effective system, Congress can start down that road by passing the Safe Food Act, S. 1281. Thank you. Senator Durbin. Thank you. Thanks, everybody. I am going to call a recess here for a few minutes as I run off to vote. And you are welcome to snack, if you would like, and I will be right back. [Recess.] Senator Durbin. I apologize for leaving but it is beyond my control. And I, again, apologize to Carol Tucker Foreman for interrupting you. Perhaps it gave more dramatic impact to your closing. [Laughter.] Dr. Henney, when I use the term, virtual reality, what does that mean to you? Dr. Henney. I do not have a lot of psychiatric training, but I would say, what does it mean to you? [Laughter.] Senator Durbin. Perfect answer. My concept of virtual reality is this new technology where you put on this helmet and you feel like you are somewhere that you are not, that you are doing things that you are not doing. And that is why I was stunned when I received a letter, which I am going to make a part of the record--from two people I consider close friends and one I respect and do not know as well--Secretary Donna Shalala, Secretary Dan Glickman, and Neal Lane, Assistant to the President for Science and Technology.\1\ --------------------------------------------------------------------------- \1\ The letter referred to appears in the Appendix on page 130. --------------------------------------------------------------------------- I wrote them a letter and asked them to respond to the National Academy of Sciences report, what the Food Safety Council had to say about fully integrating the food safety system in the United States. And I would like to read to you what they said as a group--I know these letters go through 85 different iterations and 85 different offices: ``Under the direction of the President's Food Safety Council we are rapidly moving toward creation of a virtual national food safety agency that provides a single voice on food safety issues. These efforts have resulted in Federal food safety agencies working as one, complementing one's efforts. Clearly, however, more work lies ahead to enhance and improve our achievements.'' I am still wrestling with this virtual food agency. I want to deal in the real world here of a single food agency rather than a virtual reality. And as I listen to Dr. Woteki and Dr. Henney, I admire your efforts because you not only have an important mission, in this respect, the safety of food, you have an almost impossible assignment, to try to juggle all these agencies into one operation. And it appears that the Food Safety Council is playing the role of a summit conference, bringing together all these different Federal agencies providing Esperanto texts and things so they can speak to one another and understand. And it strikes me that this memorandum of understanding which was issued in February of this year, between the Food Safety Inspection Service and the Food and Drug Administration is a lot like the Middle East peace accord. We finally have these two agencies willing to work. Can you step back for a second? Can you say, let me think not as someone in government, but as someone outside government, that the thing you are proudest of is you have everyone speaking to one another? That you have people talking to one another? It strikes me as impossible to defend to families across America that this is good government. It strikes me that you are doing the best you can with a terrible situation. How many different agencies dealing with one food product? Either beef ravioli should not be inspected every day or cheese ravioli should not be inspected once a decade. Something is wrong here. Somebody has got it wrong. What I am suggesting is could we get together and talk? Could we try to deal with one agency here? You know what happened with the egg situation. We had that at the last hearing. We said to these agencies, tell us, here is the question. What temperature should we keep eggs at to keep them safe? Now, I am not a scientist. Cooked a lot of eggs, but I am not a scientist. And we said, work on this. Come up with it. How many years did it take the FDA? Eight years to come up with the answer to that question. And then they handed it over to the USDA to do their part of the calculation. That is what is driving me crazy. And I think most of the people who watch this think, surely they are not defending this. This long lead time, this bureaucratic tangle that we have created when it comes to food safety inspection. I will repeat what I said at the outset. I really do trust both of you. I think you really do have the best of intentions in what you are trying to do and you have done your best. You are good professionals. But how--I mean step back for a second. Do you really think this is the most efficient way for us to inspect food in America? Dr. Henney. Dr. Henney. Well, Senator Durbin, you have raised a number of points. I think that we tried to outline in our testimony that where we come from on this is basically outlined for us in the laws and the jurisdiction that Congress provided to each of our agencies or the other agencies of government. I think when it comes to looking at ways in which we can make those function effectively, we have made, I would say, great strides in the last 3 to 4 years of getting this to be much better integrated, much better coordinated---- Senator Durbin. Can we address that---- Dr. Henney [continuing]. As it needs to be. But I think that to the issue of jurisdiction, at an operational level that is why we have some of these memorandums of understanding. Our jurisdiction is very clear to us. It is how we work out in the field that we have had to have many discussions between and among ourselves as to how we can do that. Senator Durbin. There was a TV show, and I cannot remember which one, and the fellow used to get up and say, the Devil made me do it. And I do not know how long ago that was. And I have heard so many witnesses say, Congress made me do it. Do not blame us. Do not blame us about all these different laws and 10 years and one daily inspection, Congress made us do that. And, you are right. Congress did make you do a lot of these things. Congress came up with these crazy ideas that do not mesh and do not make sense. I am talking about something fundamental--changing the law. And I cannot get over how professionals in this business are resisting efforts to change the law and get out of this crazy quilt of jurisdiction into something that makes sense. So, I applaud you for taking this mish-mash of law that we have handed you and trying to make something good of it. Thank you. But let us get beyond that discussion for a second. What should we do? What should the law say? As a medical professional, would it not make more sense to have one agency driven by science in a coordinated effort, a new law, a new way of looking at things? Dr. Henney. I think that the--I will come back to something that Dr. Woteki said. And that is what we are driving toward are the best public health outcomes. We are looking within the context of the strategic planning group that we have. One of the things that we are specifically looking at is the laws that undergird all of our operations, where we have gaps or possible overlap. And looking at the different models that might make us more effective. I think that we have much to be proud of. There is clearly much that we can do and each one of these models that is suggested, whether it is total independence, consolidation or better integration, all have both merits and draw backs. And that is something that we are undertaking this year to really clarify for ourselves and the thing that we have been charged with doing is making recommendations to the council and to the President about that matter. Senator Durbin. Dr. Woteki, if you had to draw up that model, with your goal public health and well-being, would it look like the current system? Ms. Woteki. No. It would not look like the current system. Senator Durbin. Why? Ms. Woteki. Well, we explained in our written testimony. There are historical roots as to why this system has evolved to what it is today and why there are the separation of responsibilities that there are. But I do think that the report that the academy made that you referred to in your opening remarks and that I did as well actually did give some very serious consideration to what structurally might be a better replacement for what we have. And they came up with four different approaches and said that those four might not be the whole constellation either. One of them is an independent agency, as you have proposed. But the other three would be a lead agency, nesting those responsibilities within one department, or the creation of a council. So, the academy report, itself, says that there are a variety of different means by which you could achieve that effective system and among the things, as Dr. Henney said, that we are doing is looking at that range of ideas in addition to some other ones that have come up through the public meetings that we have had. And, essentially are going to be working through the pros and cons. Senator Durbin. But do you not see that as you step back and look at your best efforts now and those of your predecessors that when the point that was made, and I think by Mr. Dyckman earlier, about imported food, it is just impossible for me to explain to people why your agency feels that the safest thing for American consumers is for us to inspect the plants in the country of origin and the Food and Drug Administration says, no, the safest way to deal with it is inspect the product as it arrives in the United States. And it is a totally different approach. Scientifically, should we not be able to coordinate those? I mean clearly the food products involved are so similar, you cannot say, well, it makes more sense in one area but not in others. Should we not be able to at least come to a common ground, a common solution as to what the best scientific answer is to that question? Ms. Woteki. Certainly the administration agrees that we have to have a better approach towards the safety of imported food. One of the things that for the Food Safety and Inspection Service has been very important has been the legislative authorities that permit that system of equivalency, that require us for imported meat and poultry products to make sure that the country exporting to us has an equivalent system and permits us to do those inspections overseas. FDA has been seeking similar authorities and perhaps Dr. Henney would like to expand on that. Senator Durbin. Sure, please. Dr. Henney. Thank you. I think that, yes, we have on many occasions over the course of the years sought additional authority in this area. I think that the President last month also called on us to, in the wake of no active legislation in this area, asked that we work closely with Customs to use any administrative tools at our disposal to look at how we could focus on the imported food issue in a stronger way. And we will be doing that. But this, again, is something where, as I think as Dr. Woteki points out, we would also need to be working with you and Congress about the needed statutory authorities that are really not present for us at the current date. Senator Durbin. Let me ask you this. One of the things that seems clear is that there is a lot of communication among the different Federal food safety inspection agencies. How many inter-agency coordination meetings on food safety are held each week? Does anybody know? Dr. Henney. Let me just give you a few examples. I know that we held the strategic planning meeting, the Task Force, weekly, and we would be doing that this afternoon. I think between the Center for Foods, which is the lead agency for food safety out of the FDA, and the FSIS service, the lead officials there meet on almost a weekly basis. We have strong interaction. I think, as we look at our other colleagues at CDC and EPA, in fact, we have a person from CDC who now has been located with us and we have sent a person down there. So, that there are, yes, there are many meetings weekly if not daily. Senator Durbin. That raises the obvious question. Would it not be better if we had fewer meetings and more enforcement? Would it not be better if we had one set of rules, scientifically based, that all of the agencies or a single agency was attempting to enforce? Would the consumers be better off if there was less time spent by people working in food safety at agencies trying to piece together all these different standards and all these different approaches? Mr. Dyckman, would you like to respond to that? Mr. Dyckman. Well, clearly, it would be better to have more enforcement. I guess from the efficiency standpoint regardless of whether this is food safety, aviation safety, environmental safety, I think that the track record will show that when you have an independent, unified agency that has responsibilities the better off you are. Now, of course, EPA is not perfect, but they do not have unified legislation. And we have done lots of audit reports on EPA and have recommended that. But at least all the environmental laws or most of them are housed at one agency, it is a lot easier to coordinate and communicate. I wanted to address one other point. If I may take the liberty. I attended one of the strategic planning meetings, the open meeting that the President's Food and Safety Council had a few weeks ago and one of their goals is to create a national and to the extent possible, a international seamless food safety system from farm to table. And I believe the meeting was to address how to organize or reorganize the Federal food safety system. And quite frankly, I was disappointed that I did not even see on the table the option of consolidating all Federal agencies. There were proposals to make it more seamless, to better coordinate. But as we have heard today there were four options in the National Academy of Science report including a single food safety agency. But that fourth option which is a consolidated, unified single agency was not addressed. Senator Durbin. If I could go back then. Let me ask, there was a suggestion, I believe it was in Dr. Woteki's testimony, that we are approaching this effort seriously and expeditiously and considering the full range of options. Does that include a single food agency? Ms. Woteki. Most definitely. We are considering all of the recommendations that were made by the academy report as well as the recommendations that are coming forward from these various meetings that we have had. Senator Durbin. Because Mr. Dyckman said it was not brought up. Mr. Dyckman. Yes. I attended part of that and John Nicholson, sitting behind me, attended the whole day and we discussed it when he came back. And while we have heard officials say that is one of the options at the working session to get public input, it was not offered up on the table as a possible option, and it really surprised us. Senator Durbin. Carol Tucker Foreman, you have been on the inside, on the outside, and you addressed what you would have to just characterize as the politics of this situation here. Why are we running into this resistance? Now, people who are recognized professionals in the field and have to know in their heart of hearts that this is not the way to run a railroad. Why then do we have an administration which prides itself on food safety and is unwilling to move forward with the concept of this independent single agency? Ms. Foreman. Could I say one other thing before I answer that? Senator Durbin. Sure, of course. Ms. Foreman. Not only is the unified agency not part of the discussion but at the public meeting a number of people suggested that it should be and at the end of the meeting the two Secretaries went out, met with the media and said, we do not want a single food safety agency. It would be disruptive. Boy, you bet it would. It would disrupt this nice little club. It would make people's lives change. And I think out of that would come better food safety. There is a wonderful guy at OMB years ago who said, in Washington where you stand depends upon where you sit and turf is the ultimate determiner of what your position is. These are people who are committed, but every statement that Dr. Henney made comes qualified with, we want to do these things but only with the structure that we have now. We want better health, we want better science, but only with the structure that we have now. You cannot change the structure. It is the iron law of Washington. Senator Durbin. Well, let me address one specific concern that is legitimate, that would have to be resolved here. And that is the difference in responsibility between a public health agency, like the Food and Drug Administration, and an agency like the U.S. Department of Agriculture, which combines many different things relative to agriculture. In addition to promoting products, they are inspecting products. Certainly FSIS has a health component to it, but it is a much different agency by mission. Is that part of the friction here? Is that part of the tension that we run into when we talk about a single agency? Ms. Foreman. I do not think so. First, let me point out that Congress, by creating the Under Secretary for Food Safety began to address the conflict between USDA's different missions. The Under Secretary for Food Safety has only one responsibility, to protect public health. FSIS does not have to balance safety and marketing. Incidentally, I might point out, this is the highest ranking food safety officer in the U.S. Government by act of Congress. You still have to compete within the department. On the other hand, FDA is required to accommodate the food industry, to encourage the food industry, and to encourage international trade. So, FDA has to balanced interests. If you want the best for food safety, the best for the American people, stop this virtual stuff, take these two agencies and put them together under a leader who does not have to go up the line to a Secretary. Senator Durbin. Dr. Henney, let us go right to that point. Is that one of your concerns that if you move this out of the FDA, that it would compromise what you consider to be a central responsibility when it comes to public health? That it might go to an agency, a new one, an existing one which does not share that same public health commitment? Dr. Henney. Senator Durbin, I have not foreclosed conclusions here. I think that if you look at the issue that we are both driving for, both the reorganization that was done at USDA and within our own organization, public health is the bottom line. We come from that at the FDA from a variety of standpoints. Our history is in public health, what we have always done is always geared at the public health. We are a science-based regulatory agency that has a very long and proud history in this regard and we are also advantaged, we believe, by our sister agencies within the health department such as CDC and NIH and the like. I think that the working relationship that we have with the Agriculture Department for the other commodities that they regulate and the recent accommodation that was made in terms of public health being under the purview of the Under Secretary did separate that issue that had been present before in terms of marketing and public health. But we feel proud, quite frankly, of the fact that our whole history has really been driven by this issue and will remain that. Senator Durbin. Well, Dr. Woteki, I would like you to have a chance to respond to this as well. This is something that is often--this is the bottom line here. The turf battle goes over a lot of different aspects but one of the most basic is whether or not your agency, the Department of Agriculture, for example, could even take on this responsibility if it were given the entire food safety responsibility, because of some of the internal conflicts which have been written about over the years. What are your thoughts on that? Ms. Woteki. Well, I think that the greatest gains we are going to make in the future with respect to food safety are going to be ones that are premised on prevention. Techniques that we can put into place at the farm level as well as during processing and through the retail and preparation areas. The greatest gains though I think are really going to come in the prevention on-farm as well as in the processing areas. And those are going to require an enormous amount of further scientific research to develop the new technologies that can be applied, that are going to be cost-effective, and that will continue to deliver to the American consumer a high quality and safer food product. Senator Durbin. But the basic bottom line--I am sorry. Ms. Woteki. So, our whole approach that has guided what the Department of Agriculture has been doing for meat and poultry and egg product inspection and also that is guiding now the President's food safety initiative is this farm to table approach with a heavy emphasis on R&D as well as the adoption of science-based approaches in our regulatory systems. Senator Durbin. I guess the bottom line question though, is can your agency promote a product as well as oversee it, inspect it and do it with credibility? Ms. Woteki. Well, I think you can look to our record of the last 5 years, since the reorganization. And the answer to that is, yes. We have implemented this new science-based HACCP approach in meat and poultry. We have seen a very high compliance rate in the industry and recent data from CDC has indicated that there is a dramatic decrease in salmonellosis that parallels the declines that we are seeing through our own performance testing on products. That has been done. There has been a high rate of industry compliance and it has been quite successful. Senator Durbin. Mr. Dyckman, you noted that several countries have started wrestling with this question on their own and have come to different conclusions on it, if I understood your testimony. It was a situation in England and Ireland that they move toward more of a public health orientation and if not, if I do not remember correctly, Canada and Denmark moved more toward the agricultural side of it. Could you explain, if you have it there or if you know, what drove those decisions? I know the mad cow outbreak and other things were issues in England. Mr. Dyckman. Well, it was obviously, distrust in England and Ireland for Federal regulators that dealt with food safety. And, so, they chose to place their responsibilities in a health oriented agency, that is under the Health Ministers. It was less of a concern for the other two countries. They were more concerned with economy and efficiency. If I might return to your question that you asked the other two witnesses. GAO places a lot of emphasis on integrity and accountability. Integrity composes many aspects and it includes many things. One of them is clearly an appearance of a conflict of interest and I think you alluded to that today. There are questions, legitimate questions about whether or not an agency that promotes an industry should also regulate parts of that industry, even if there is a firewall. And I think Agriculture has a firewall. But still there are questions. Questions to the extent that if we were to start from scratch, we would avoid the appearance of conflicting interests. Accountability is another important issue in government, not just in food safety but all aspects of government. The U.S. taxpayer has the right to demand answers from one official who could represent an issue or set of issues. We do not have that in food safety right now. It is spread across various agencies as we have discussed today. And that is why there is such an effort to coordinate. Now, obviously, even if you put all food safety responsibilities or many of them in one agency there still would be a need to coordinate but at least you would be able to go to one agency official, to have one person testifying today on food safety representing the administration and would be able to say ``yes,'' I can make that change or explain the reason for not making that change. You would not have to go to several different agencies. Senator Durbin. I think that is the bottom line and the reason why, obviously, I am pushing for the idea that I believe in. But I also have the highest respect for all who have testified today who may see things differently. And I repeat what I said at the outset, I believe you are all professionals. I think you are doing the very best in terms of food safety for this country. I just think we can do it better and I hope that perhaps your testimony today and this hearing will cause some within the administration to understand that what I have in mind is not disruptive but, in fact, will create a more efficient approach. And I thank the panel very much for your testimony. Dr. Henney. Thank you. Ms. Woteki. Thank you. Senator Durbin. The next panel that we have includes Nancy Donley of Chicago, President of Safe Tables Our Priority; Caroline Smith DeWaal, Director of the Food Safety Programs for The Center for Science in the Public Interest; Dr. Rhona Applebaum, Executive Vice President for Scientific and Regulatory Affairs of the National Food Processors Association; and Dr. Stacey Zawel, Vice President for Scientific and Regulatory Policy for the Grocery Manufacturers of America. So, Nancy, if you are prepared, if you would lead off and then we will allow the others to join in. Thank you for being here. TESTIMONY OF NANCY DONLEY,\1\ PRESIDENT, S.T.O.P., SAFE TABLES OUR PRIORITY Ms. Donley. Thank you, Senator Durbin for inviting me here today and thank you for your years and ongoing many, many more, I hope, in leading such good efforts in food safety. It has not gone unnoticed. The American public thanks you for it. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Donley appears in the Appendix on page 92. --------------------------------------------------------------------------- I was invited to testify here today on a subject that has become the single most important issue in my life and that is food safety. Until July 18, 1993, food safety was a non-issue as far as I was concerned. I did what most of the public does, I assumed that the food we fed our families was safe. I assumed that our government had the situation of ensuring the safest food safety possible well in hand. I assumed that the food industry was governed under the strictest of regulations to produce food of the highest safety level possible. I assumed that companies violating food safety law were dealt with swiftly and harshly. I assumed that there was an entity ultimately responsible for protecting my family from unsafe food. I assumed wrong on all counts, dead wrong. On July 18, 1993, my only child, my 6-year old son, Alex, died a brutally painful death after eating E.coli, 0157:H7 contaminated hamburger. Alex wanted to be a paramedic when he grew up so that he could help people. So, when he died, we wanted to donate Alex's organs to fulfill his wish in helping others. We were told we could not. The toxins produced by E.coli 0157:H7 had destroyed his internal organs and they had liquified portions of his brain. My son suffered horribly and I still suffer and grieve every day, 6 years later and I will for the rest of my life. And this happens to millions of people every single year. After Alex's death I joined S.T.O.P., Safe Tables Our Priority. S.T.O.P. is a national nonprofit foodborne illness victims organization that was founded in the wake of the Jack- in-the-Box E.coli 0157:H7 epidemic in 1993 that killed 4 children and sickened over 700. Our founders include parents of children who died or were seriously injured from eating contaminated meat. Since then our membership has expanded to include people impacted by many different foodborne pathogens from all food groups. Our mission is to prevent unnecessary illness and death from foodborne pathogens. When I learned that Alex had died because his hamburger was contaminated with cattle feces, I was determined to understand where the system had failed and it has been an incredibly eye- opening experience for me. S.T.O.P.'s initial focus was on fixing the E.coli 0157:H7 problem, a problem then thought to be confined to beef. I learned that at the time of Alex's death meat inspection did not include any measures to address microbial contamination. So, I worked extensively during the rule making process for FSIS's pathogen, hazard analysis and critical control point regulation which mandated microbial testing for the first time in history. Also, during this time, E.coli 0157:H7 was declared an adulterant in ground beef and safe food handling labels were required for all raw meat and poultry products sold at retail. Things were definitely looking up in the hamburger disease fight as E.coli 0157:H7 was commonly referred to. But then we learned that E.coli 0157:H7 is not just a hamburger problem. The primary reservoir of 0157:H7 is found in cattle and the first incidence and outbreaks of E.coli poisoning were found in ground beef. But outbreaks have subsequently been linked to such diverse foods as lettuce, sprouts, cantaloupe and apple juice. Japan had a national epidemic that infected over 10,000 people with contaminated radish sprouts being the suspected vehicle. Several months ago school children in Europe became sick from E.coli 0157:H7 contaminated goat cheese and E.coli 0157:H7 outbreaks have been linked to contaminated drinking water and in my home State of Illinois, children became very sick after swimming in a contaminated reservoir. This single pathogen, which is why I went through this list, affects products that is regulated by the FDA, FSIS and EPA. So, while FSIS was dealing with the problem in meat, prevention strategies were not put in place for other products that could be affected by the same pathogen and that was because no one was looking at the overall big picture. There appears to be a dangerous tunnel vision occurring within the individual agencies where they focus only on their small world and do not see how happenings in other areas might be of relevance to their own. The invitation to this hearing contained the following questions: One, if the Federal Government were to create a food safety system from scratch, would it resemble the current system? And, two, is this the best and most logical organization for Federal food safety agencies? If the Federal Government were to create a food safety system from scratch I cannot imagine it creating the fragmented system that exists today. The reason that it is so hodge-podge is that it was never planned. It just evolved into what it is today. Food safety was not the concern historically that it is today. Rather quality and labeling issues were the driving forces. So, consolidating food safety activities into a single independent agency would elevate food safety, prevent duplication, and fill-in gaps that currently exist in our multiple-agency system. A single independent agency would be better prepared to handle emerging food safety issues. It would be more efficient, more effective, and more responsive. The current structures of agencies within even larger departments undermines the importance of food safety because these departments have such broad and diverse agendas, but food safety always gets very--very often can get overlooked or does not receive the attention it deserves. FSIS is a subset of the USDA, a huge department, whose responsibilities include everything from forestry to circus animals. It is even more complex with CFSAN, a subset of the FDA, which is a subset of HHS. When you are such a tiny piece of the pie you do not command much attention. And food safety deserves to be the entire pie. It is time to face the fact that the current system of multiple agencies regulating food safety is simply not working. Victims are falling through the cracks because of the lack of a single cohesive food safety program. Imagine what might have happened if a single food agency had been implemented immediately following the Jack-in-the-Box epidemic. A single independent entity responsible for all foods including meat would have looked at the animal reservoir pathogens in a larger context. While developing a program to address the animal pathogens in meat, it would have logically and simultaneously looked at the potential of animal waste contaminating other foods as well and developed prevention strategies. These produce-related foodborne illness outbreaks might have been avoided all together. Our organization has members who were victims of the juice and lettuce outbreaks who question why did not government anticipate such a problem occurring? They want to know who was in charge of the safety of the food that made their loved ones sick? The answer is, tragically, a dual one. There were too many in charge and yet no one in charge. We strongly support the implementation of a single independent food safety agency. The safety of the food we feed our families is of critical importance and deserves the uncompromised scrutiny and attention of an agency unencumbered with other conflicting responsibilities such as trade and marketing issues. Now, many industry associations support the status quo of the marketers. Senator Voinovich [presiding]. Ms. Donley, your time is almost up. Ms. Donley. Oh, I am sorry. In conclusion, we oppose such an arrangement to have conflicting agendas within agency. So, I would just like to say that it is time to acknowledge that we are beyond fixing the current situation and we really hope that turf wars will be set aside and just focus on protecting the common people. That is what we count on government to do. Senator Voinovich. Thank you very much. Ms. DeWaal. TESTIMONY OF CAROLINE SMITH DeWAAL,\1\ DIRECTOR, FOOD SAFETY PROGRAMS, CENTER FOR SCIENCE IN THE PUBLIC INTEREST Ms. DeWaal. Thank you very much and I want to thank Senator Durbin for his tremendous leadership and Senator Voinovich for your willingness to look at this question. I am Caroline Smith DeWaal. I am Director of Food Safety Programs for The Center for Science in the Public Interest. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. DeWaal appears in the Appendix on page 96. --------------------------------------------------------------------------- CSPI is a nonprofit organization based in Washington and we have been working for over 25 years to help improve the public health largely through our work on nutrition and food safety issues. We are supported by over a million subscribers to our Nutrition Action Health Letter. Food safety experts believe that contaminated food causes up to 81 million illnesses and 9,000 deaths each year. While these estimates illuminate the magnitude of the problem, for many consumers these aggregate numbers mean less than the specific outbreaks and recalls, such as the Jack-in- the-Box outbreak, the outbreak from Odwalla juice, the Hudson Food recall where millions of pounds of ground beef were recalled or the most recent Bil Mar outbreak linked to listeria in processed meat products. These well-publicized cases have awakened consumers to the fact that contaminated food is a greater risk than we thought. Food contamination problems are cropping up in such health foods as apple cider and alfalfa sprouts to such traditional favorites as hamburgers and hot dogs. It is hard to know any more what is safe to serve your kids or your aging parents. CSPI has been collecting data on foodborne illness outbreaks for several years. Today we are releasing an updated version of this data in a report called, Outbreak Alert: Closing the Gaps in Our Federal Food Safety Net. In this listing of over 350 outbreaks FDA regulated foods were identified in three out of four of the foodborne illness outbreaks. Yet, FDA receives roughly one out of every four dollars appropriated for food safety regulation. This disparity is only one of many created by our current system, which spreads responsibility for food safety among numerous Federal agencies. Senator Voinovich asked us to address the following questions. If the Federal Government were to create a food safety system from scratch, would it resemble the current system and is this the best and most logical organization for the Federal food safety agencies? The answer to both of those questions is a resounding, no. It makes no sense when food safety problems fall through the cracks of agency jurisdiction. It makes no sense when multiple Federal agencies fail to address glaring public health problems. It makes no sense to have a single food processing plant get two different, entirely different food safety inspections while other plants get no Federal inspection at all. It makes no sense that the widely touted HACCP program is markedly different at the Food and Drug Administration and at the Food Safety and Inspection Service. It makes no sense that new food safety technologies face multiple hurdles at various agencies before they can benefit consumers. It makes no sense that the United States inspects imported food differently depending on which regulatory agency is in charge. Quite simply, the current food safety system makes no sense for today's consumers. CSPI documented these problems last year for the National Academy of Sciences panel that wrote ``Ensuring Safe Food from Production to Consumption.'' This year we have documented even more problems. For example, for State laboratories there are no minimum testing requirements when they are checking food. They actually have to run different testing protocols depending on which agency they are running the test for. This means that contaminated food recalls and outbreak announcements can be delayed for several days while Federal agencies retest products to confirm the findings of the State laboratories. Another example is genetically modified plant species. These are subject to a mandatory review at our APHIS, our Animal and Plant Health Inspection Service, to ensure plant health and safety. But only a voluntary review at the Food and Drug Administration to ensure human health. The agencies want us to believe that they can coordinate their way out of these problems. It is true that the Clinton Administration has worked hard to address many pressing food safety problems. Despite their best efforts, however, coordination will never provide the whole solution. While a joint FDA-FSIS egg safety task force has been meeting for years, neither agency has proposed on-farm controls for Salmonella that infects eggs. In addition, a memorandum of understanding between FSIS and FDA on inspection issues failed to net any meaningful change because USDA is statutorily limited to conducting only meat and poultry inspections. These examples show that coordination cannot ultimately address many of the problems with the current system. In Vermont, where I grew up, there is a joke a city slicker who asks directions from an old Vermont farmer. The punch line is, you cannot get there from here. Today we all want the safest possible food supply. But like that old Yankee farmer, I am afraid that you cannot get there from here. That is why CSPI strongly supports the Safe Food Act of 1999. Thank you very much for your time and attention. Senator Voinovich. Thank you very much. Dr. Applebaum. TESTIMONY OF RHONA APPLEBAUM,\1\ Ph.D., EXECUTIVE VICE PRESIDENT FOR SCIENTIFIC AND REGULATORY AFFAIRS, NATIONAL FOOD PROCESSORS ASSOCIATION Ms. Applebaum. Thank you, Mr. Chairman. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Applebaum appears in the Appendix on page 119. --------------------------------------------------------------------------- My name is Rhona Applebaum and I serve as the Executive Vice President for Scientific and Regulatory Affairs for the National Food Processors Association. NFPA appreciates this opportunity to offer comments on the organizational structure of our Nation's food safety system. Because our primary mission is food science and food safety, we have a very direct interest in providing input on this proposal. In the few minutes I have this morning, I will briefly address the effectiveness of our current food safety system and some of the challenges to public health that system faces as well as why we believe a single food safety agency is not necessary to meet those challenges. While NFPA does not endorse S. 1281, the Safe Food Act of 1999, we commend its author, Senator Durbin, for his legislation's goal of enhancing food safety, an objective shared by the food industry. Our means to the end is where we differ. Our approach embraces a single food safety policy not a single food safety agency. If the Federal Government were to start from scratch to establish a food safety regulatory system would it resemble the current system? Probably not. But then numerous other government agencies, whose missions parallel and/or compete with one another might also look differently with the benefit of a clean slate. We should be mindful that our existing food safety system has evolved over many decades and enjoys the confidence of the overwhelming majority of the American public. In short, the system works and it continues to evolve toward an even more effective system in the future. Rather than focusing our efforts on creating a new agency, our energies would be of greater benefit if we focus on enhancing the strengths of the existing system. The current regulatory framework in the United States, with shared oversight of food safety by FDA, USDA, and several other agencies, has resulted in Americans enjoying one of the safest food supplies in the world. So, while there may be ways to improve the current system, it is not accurate to say categorically that the system is broken and needs to be replaced. There are two primary reasons why our current system works well. The first is that safety is the food industry's No. 1 concern, our principal focus. Safety is job one, as the saying goes. Second, the current food safety system is largely based on sound science and a mutual commitment to food safety by both food companies and all agencies involved in their regulation. But can the system be improved? Absolutely. Our plea is to work together to enhance not demolish the existing framework. NFPA believes that it is unnecessary to have a single food agency to improve the system. Three goals should be considered when discussing improvements to our current system. These include, first, better coordination among various Federal, State and local government agencies. Second, a single scientifically based Federal food safety policy which ensures uniform and consistent food safety guidelines and requirements. Third, and of extreme importance, is that sound objective science must be the basis for any changes and improvements to our food safety system. This view is endorsed by both the National Academy of Sciences and the President's Council on Food Safety. Sound science must be the tool used in determining the allocation of resources in the food safety regulatory framework. Mr. Chairman, in closing, NFPA believes that incorporating better agency coordination and more consumer education along with increased surveillance and better agency resource allocation in terms of risk assessment to consumers will go a long way to enhance the safety of the U.S. food supply and work is underway to see these actions realized. NFPA recommends that Congress examine the recommendations of the National Academy of Sciences and the changes being designed and implemented by the President's Food Safety Council before considering such drastic measures as the creation of a whole new government bureaucracy. As stated in our written comments, our system is not so flawed that it needs to be razed. It simply needs an upgrade and some remodeling. Again, Mr. Chairman, I thank you for the opportunity to provide testimony to this Subcommittee and welcome any questions you or other Members may have. Thank you. Senator Voinovich. Thank you. Dr. Zawel. TESTIMONY OF STACEY ZAWEL,\1\ Ph.D., VICE PRESIDENT FOR SCIENTIFIC AND REGULATORY POLICY, GROCERY MANUFACTURERS OF AMERICA Ms. Zawel. Thank you, Mr. Chairman and Senator Durbin for the opportunity to come before you today to talk about this very important issue. As you know, my name is Stacey Zawel, and I am Vice President of Scientific and Regulatory Policy for the Grocery Manufacturers of America. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Zawel appears in the Appendix on page 124. --------------------------------------------------------------------------- And like I said, I definitely welcome the opportunity to come to talk to you and recommend ways to refine but not replace our Nation's food safety system. If we were starting from the beginning and had the luxury of creating a food safety system from scratch, GMA would recommend that the system be based on four fundamental principles. First, regulatory controls would rest on science-based assessments of risk, not speculative hazards. Second, education about proper methods of food handling and preparation would be provided at all stages of the food chain. Third, adequate staffing and resources would be provided to administer this food safety system. And, fourth, industry and all sectors of government would pledge to work together in a coordinated manner to maximize food protection. But the fact of the matter is we are not starting from scratch. We already have a food safety system in place. Critics argue that it is fatally flawed by a lack of coordination among the responsible agencies and senseless duplicative effort. They are wrong. The existing system is a successful partnership among government, industry and consumers, the diversity of the regulatory players adds a breadth and a depth of experience that is crucial in addressing the multi-faceted nature of the food safety challenge. The President's Council on Food Safety, which includes Secretary Shalala and Secretary Glickman, is working on a strategic food safety plan that will focus on enhancing cooperation among the responsible Federal agencies. Planned measures include a unified food safety budget and a single research plan. In the face of this commitment to enhance coordination at the highest levels of government, it is simply ludicrous to suggest that the present food safety system must be entirely scrapped. We need to work with the successful system we have, giving the Council on Food Safety time to make the adjustments necessary to perfect it. Any other course would be enormously disruptive and very expensive. GMA believes, therefore, that the question we should be asking today is not necessarily how can we build a food safety system from scratch but how can we assist the Council on Food Safety in improving the one that we have? GMA would suggest a renewed focus on the four basic principles I discussed earlier. The first one being that the food safety system must be based on science. Especially as food production, processing and distribution increases in complexity and sophistication, we must rely upon scientific techniques to detect and address potential food safety hazards. We have to identify and fight the true causes of foodborne illness with the right scientific weapons and those weapons can only be developed and refined through laboratory research and practical testing. We are starting to achieve some of the benefits a science- based approach can bring and every effort should be made to ensure that this direction continues. For example, new techniques to reduce bacterial contamination such as irradiation and certain chemical compounds are being developed that offer encouraging results. USDA's adoption of the hazard analysis critical control point systems approach, a process control originally developed and used voluntarily by the industry has the potential to transform the antiquated meat and poultry inspection system from one based on sight, smell and touch to one founded on science-based assessments of risk. Although implementation challenges abound this technique and others do show some promise. USDA, FDA, and other Federal agencies, working with the States and industry, must continue their focus on the science and research. The second one is education and proper handling must be promoted. The handling of foods at all stages of the farm to table production chain affect safety. And everyone has a responsibility for and must be educated with respect to the proper and safe methods for handling food products. Third, adequate resources are definitely needed and have to be properly employed. Without properly trained personnel, state-of-the-art equipment and the necessary funds an emphasis on science and research is meaningless. Although FDA has historically enjoyed respect throughout the world, the agency's reputation is being threatened by a depletion of resources for food safety. Similarly, although FSIS is better funded, the agency's labor-intensive is both costly and antiquated. Fourth, Federal food safety agencies must also work cooperatively. Coordination is a challenge in a food safety system that draws upon these multiple disciplines, expertise, and history of several executive agencies. But replacing the successful system we have with a single agency is not a magic bullet for enhancing food safety. Moving boxes around on the government's organizational chart simply will not make food any safer. And in conclusion, what I think we need to do is focus on the Council on Food Safety that has already created a coordinated food safety system, united by a single budget and a research plan that the proponents of S. 1281 are seeking. Before embarking upon an expensive, disruptive reorganization, we owe it to the American people to see if the Council's strategic plan and related activities can address any challenges that exist and move the country to a new level of food safety and protection. That concludes my remarks and thank you very much for the opportunity to testify today. Senator Voinovich. Thank you. My impression is that the problem today in the country is a lot more severe than it was, say, 25 or 30 years ago, in terms of more food being processed and more people buying pre- packaged things and the rest of it. That is the first impression I have gotten from this testimony. Second, that the diseases that are out there are a little more rampant than they were in the past and are more diversified than what we have encountered in the past. When did the Council on Food Safety get organized? When were they brought together to talk about looking at this, do you know? Ms. Applebaum. Approximately a year ago. Senator Voinovich. A year ago. The President has been in office 7 years. Go back and look at the studies about this problem which is, by the way, like so many other problems in the Federal Government. Just unbelievable. GAO report after GAO report after GAO report says that this is something that should be done and everyone says they are going to do something about it, but it does not happen. From what I can see from listening to this testimony, this is all over the lot. Dr. Zawel, why is it that you think that it would be terribly disruptive and cause all kinds of problems and so forth? I agree with a lot of what you said. This should be done, and this should be done, and this should be done. But, you know something? It hasn't been done for a long time. I know from my experience in government that when you have people all over the lot, everybody has got to get coordinated. We have, frankly, Senator Durbin, too many committees looking at too many things, and you cannot coordinate. It is just mind- boggling. Dr. Applebaum, why don't you think it makes sense to take this stuff, get it on the table, try to reorganize it and get one agency and start from scratch and get the job done and do it right? I would think that industry would welcome it. You have one group coming in, another group coming in. I was just talking to the Ohio director of agriculture, and they are trying to get the State organized because it is not as coordinated as it ought to be. I would like your comments. Ms. Zawel. Well, let me just reflect some of what I said in my statement which is that our, I guess, opposition to a single food safety agency does not, at the same time, reflect that we do not think there are problems with the current system. There are some real challenges and that the system has been developed, as Dr. Applebaum has said, through a long history of events, which has brought us to where we are today. And, so, I do not think that I will necessarily go to the mat and say, every single aspect of today's current system is definitely ideal. I think we definitely need increased coordination, and all the other things that we called for. What I think would be terribly disruptive is to just decimate everything that we have, build brand-new infrastructures and build brand-new agency with a single head. I do not know. I am truly not convinced that that, in and of itself, is going to result in all this food safety challenge just going away. Senator Voinovich. Well, one thought that I have had is that if you are going to do this, I am not sure you would create a whole new agency. I would probably determine what agency is most involved in this area, perhaps the Department of Agriculture, and say, they are the most into this and then try to figure out how FDA could be folded into that. I would not start with a brand-new infrastructure. I do not think that would make the most sense, and would try to work out some system of doing it that way. Ms. Zawel. I think that with respect to coordination, which I think is probably one of the biggest challenges that any infrastructure has and certainly this one where we have multiple agencies, it is a challenge to coordinate. But at the same time if you look at any one organization, whether it is Congress or whether it is one single company, there is always challenges to coordinate. There are always going to be turf battles. So, the key to necessarily decimating all the turf battles is well--which I think is one of the biggest issues that you guys have in recommending the agency and making it more effective. I am not sure that that key is one agency, in and of itself. Senator Voinovich. I would add that it depends on where these responsibilities are in an agency. I have been through this as governor, and we formed cabinet councils to coordinate, but the issues that we were coordinating had relative priority in those agencies. The issue is where does this particular matter fit into the overall structure of an agency, and is it way down in Health and Human Services, which has tremendous responsibility? You just wonder how much attention does this particular area get from that agency, and would it receive a lot more attention if it were, say, located in the Department of Agriculture? Any other comments, Dr. Applebaum? Ms. Applebaum. Yes, Mr. Chairman, if I could just make some comments in regards to your observation. There seems to be, I will use the term, an epidemic, if you will, that you relate to foodborne disease. In that regard there is heightened awareness. The public is more aware of the fact that there is illness that can be conveyed through the food. So, there is a heightened awareness and people are more aware of the fact that there could be a food-related issue associated with the disease. And there are also more virulent organisms that we have to be cognizant of. The organisms that we are dealing with today are not the same ones we dealt with 25 or 50 years ago. But we also must be cognizant of the fact that there are different practices that we are following as consumers. We are looking more and more towards less processed. We do not necessarily cook our food like we did in the past. There are differences in education that was done in the past than that done currently. So, there are a whole lot of factors involved in terms of what is being implicated and blamed on, if you will, the increases in illnesses. The food industry does not take even one illness with any type of frivolity or look at it in a trivial way. We are very much concerned with that and it is very important. I want to get back also to the second point that you raised with Dr. Zawel; that is, Do you not think that the best way to the end, the means to the end in this regard, is just to focus everything on one particular agency? Let us have one body, one entity, a body that we can go to and then we can get all these things fixed. I think we all share the common goal of enhancing and improving the safety of our food supply. That is first and foremost in NFPA's concern and the members that both Dr. Zawel and I represent. The difference here is that we feel the solution to this problem needs a plan first, and the plan we view is a single food safety policy. Put the policy in place. Then, in terms of whatever house it is in, that will come later. We are looking now in terms of the advancements that have been done to date related to the NAS report as well as the President's Food Safety Council. There have been advancements made; even though they have only been in place for a year, progress is being made. We are looking at this, I am looking at this, our association is looking at this in terms of the advancements being made. Our food supply is not perfect, but there are things that have to be done. Better coordination, better integration, having everything based on sound science. But do we pull back and stop the advancement when there is advancement being made only to retract and take another direction that has no justification? There is not any evidence as to whether or not a single food safety entity is the best means to the end. That is our basic difference in this regard. We would like a plan. We would like the plan based on a single food safety policy; then enact that policy. It is the policy that is going to ensure the safety of the food supply, not a single entity, not a single agency, in and of itself. Can there be consolidation? Absolutely. Can there be consolidation of current statutory authority? Absolutely. We have been working on that for quite a long time. But to just demolish a system that is working and working effectively and is the model that the rest of the world is looking towards in order to pattern themselves, we do not think makes a lot of sense. Senator Voinovich. Thank you. Yes, Ms. DeWaal. Ms. DeWaal. Thank you, Senator Voinovich. I want to introduce, to pick up on another line that you were talking about and that is the relationship with the State Governments. I went to a meeting of the Association of Food and Drug Officials and these are the State people who really spend a lot of time regulating food. And they spent a lot of time talking to me about their concerns about the current Federal system. The State lab example I have given you. They have four different testing protocols depending on which Federal agency they are preparing a food sample for. In the area of outbreak investigation, the State will initiate an outbreak investigation but until they know what food is implicated, who do you call? And there is no ghost busters here. There is no food busters. They cannot even call a Federal agency, regulatory agency until they know whether it is a USDA or an FDA regulated food. In the area of State inspection there was a lot of concern right now USDA and FDA are developing new systems. And I am really encouraged that they are doing that to work more closely with their State partners. So, if a State inspector goes into a food plant you will not have a Federal inspector go in the next day. Well, the way they are doing this is with little laptop computers that these State inspectors will carry around with them and they will link-in electronically with the Federal system. Well, what if we have a laptop which is the USDA laptop and a laptop which is the FDA laptop and then they still have got their State laptops. There has to be a better system. We have 50 States who work on food safety. Every State has food safety responsibilities. And they are trying to link up with these multiple Federal agencies and they are having a hard time. I just want to talk on the Department of Agriculture issue. I understand that it is very appealing to think that you could maybe house everything over at USDA. And I think there is a big trust issue, though. And when President Nixon thought about forming the Environmental Protection Agency there were environmental functions spread out all over the Federal Government. And many of them were at the Department of Agriculture. But he decided that they needed, first of all, to create a new infrastructure to get the right focus on environmental protection and we have seen real results from that. And, second, he did, he formed the structure first. We just heard from NFPA that they want the plan first and the structure second. Well, that is not what happened when President Nixon looked at it. He formed the structure first and then Congress passed the laws that developed the plan. The Clean Water Act, the Clean Air Act, and many other laws which that agency now enforces. So, and in Canada, today, they are looking at more gradually combining food safety functions but they formed the structure, an independent inspection agency first and now they are just getting around to changing the laws. So, I think those are some things that you should think about as you consider that. Forming a plan first may take us 10 years. I am not sure that we can afford that. Senator Voinovich. Any other comments? I know that Senator Durbin has some questions. Ms. Donley. I would just like to, if I might, Senator Voinovich, to your point of I wrote down here that it sounded like you were suggesting perhaps to fold it into an existing agency or department. And then you mentioned a point that I brought up as well that there in HHS, for instance, you used the example that it is so huge, it has so many responsibilities that there is a lack of attention. And I say that that is also the case in USDA. But if we are really going to do something and really take it the next step I think we should take it completely and make the next step that, make the complete move. And give something that is going to give the public confidence. The public is concerned with what it views as a conflict of interest in agencies that have marketing responsibilities and trade responsibilities also being the regulators. And, therefore, that is why we really see the need for this agency to be independent. Senator Voinovich. Thank you. Senator Durbin. I would like to note that we have got a vote. The buzzer is coming up. Senator Durbin. That is good news for the panel. [Laughter.] Because I will try to wrap up very briefly. Senator Voinovich. Yes. Because I think after that we probably should adjourn. Senator Durbin. I will. I will just ask a few questions and then we can both leave to vote or you can leave early if you would like. It is your decision, Mr. Chairman. Thank you for your testimony. I appreciate all of you being here and Nancy Donley, an old friend, thank you for reminding us that this is a life and death issue because your family was touched by that tragedy. And I have never forgotten the first hand-written letter you sent me so many years ago which brought my attention to this issue. And I just want to say very briefly, I agree with you. I think that we really have to think about the agency and its responsibilities so the mission is clear and the people understand what that mission is. USDA, by virtue of numbers and responsibility, looks like the obvious place to turn. But it does have some conflicting responsibilities here, at least responsibilities that are not necessarily complementary to a regulatory attitude. And that is something that I would look at very carefully. As much as I like the USDA, I would have to look at that very carefully. FDA, a smaller part of the pie, one-fourth, I think when it comes to the employees involved in it, has a major part of their responsibility, as Caroline Smith DeWaal has said, with three out of the four of the outbreaks coming through foods that were inspected or should have been inspected by that agency. And they certainly do not receive the money they deserve for the important responsibilities that we send their way. I would like to say to the two witnesses that come from the private side, because I only have a couple of minutes here, rather than being discouraged or upset or angry or confrontational I am encouraged by what you had to say. I do not know if this is a conscious decision or maybe I am looking for that pony on Christmas morning, but I really sense that there is a change in attitude here and it is a good one and more open-mindedness about this. And I do not disagree at all with what you have said. I mean it is really a chicken and egg, I guess it is a good analogy here, as to whether we are going to start the structure and then bring policy or start with policy and then bring structure. My guess is we are going to end up at the same place, either way. Because once we sit down and try to explain to your manufacturers and processors why we have an inspection of one of these products every day and another one every 10 years, it is going to come together when we say there is only one way to decide this and that is science. Any other way is pure politics or commercialism. It has to be science. What is the scientifically defensible approach to this? We are trying to sell that to Europe now so our products have a chance. We are as inclined to hyperbolic rhetoric as anybody on this side and I plead guilty. But we are not trying to do anything drastic or demolish or disrupt. I really think that if this is going to be done sensibly that it is going to have to be a reasonable transition here. We are bringing together a lot of ideas, a lot of science, a lot of agencies, and a lot of players trying to make this thing work better for American families. If we do not do it carefully we could lose ground rather than gain ground. So, more than anyone here as the champion of this cause, I will tell you I am determined to make sure it is done right if it is ever done at all. And that is not an overnight, super agency, conceived and created by one piece of legislation. I do not think it will ever happen that way, nor should it. We should really think this thing through and make sure when it is done that the change is for the better. The last point I will make, and I will give you a couple of minutes to respond if you would like, is I met with an executive of a major company, and I will not go any further to identify him, last year for breakfast. And he said, what are you working on? And I said, food safety. And his company makes a lot of food products. He laughed at me. Why are you doing this? He said, we have the safest food supply in the world. Cannot you find something better to do with your time? And that kind of took me aback and I did not quarrel with him, I respect him very much. And I said, well, I think it is an important issue. It was not but weeks later that he got hit with a major, multi-million dollar problem in this company involving food safety. And he was on the phone to me talking about food safety. As confident as we are of the goodness of our food supply, as much as we want to see it continue to be good, we know that terrible things can happen and we want to do our best to avoid them. And that is really what I am about here. I do not think that there is strength in the diversity of regulatory players, as has been said here, in one of the testimonies. I really think we have too many different voices. This Tower of Babel mentality where these coordinating meetings are going on night and day to try to keep these agencies working together. Would it not make a lot more sense to bring them all under one roof, on a science-based, sound theory and approach on food safety? I hope it will. Senator Voinovich. I would like to make one point before we have to go vote on the agriculture bill. We talked about the needs and so forth. But one of the big areas that we need to be concerned about is exporting our products. We are seeing more and more artificial barriers put up to our products, saying they are not healthy or they are this or they are that. I think that we need to be a lot more authoritative and united in terms of the quality of our products in terms of how to deal in the world market place. Because they are going to find any excuse they can to keep us out of that market place today. So, it is just another ingredient that may not have been around 25 or 30 years ago. Senator Durbin. That is all I have. Senator Voinovich. Any comments? Senator Durbin. Rebuttal? Ms. Zawel. I would just conclude and say that I think that we have the same interests in mind in terms of assuring that we have the utmost safest food supply in the United States and obviously we would certainly encourage, as we have, multinational companies that we represent, that that same product is safe as it goes across the oceans. And, initially I think Senator Durbin, you had said that you wished the industry would stop resisting or Chairman Voinovich, I cannot remember which one. And, I think that that is not necessarily, and I hope you recognize, where we are at. We definitely want to work towards ensuring and enhancing the food supply as much as we possibly can further. But that we believe, with all due respect to Caroline, that the plans and the policies that change and affect that system to make it better are really what is key and not necessarily the structure. Senator Voinovich. I would like to finish with one remark. I have a lot of confidence in the food industry that wants to put out the best products it can. They want quality products. They know that if they have problems that it is going to hurt the business. I think that sometimes those of us in government forget that the private sector is doing everything it possibly can to make sure that there are healthy products out there. Because they understand how important it is to the safety of the public and also to their businesses. Thank you very much. The meeting is adjourned. 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