[Senate Hearing 106-283] [From the U.S. Government Publishing Office] S. Hrg. 106-283 EGG SAFETY: ARE THERE CRACKS 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 __________ JULY 1, 1999 __________ Printed for the use of the Committee on Governmental AffairsU.S. GOVERNMENT PRINTING OFFICE 59-578 cc WASHINGTON : 1999 ------------------------------------------------------------------------------ For sale by the U.S. Government Printing Office Superintendent of Documents, Congressional Sales 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............................................... 3 WITNESSES Thursday, July 1, 1999 Lawrence J. Dyckman, Director, Food and Agriculture Issues, U.S. General Accounting Office, accompanied by Steve Secrist, San Francisco Regional Office...................................... 6 Morris E. Potter, D.V.M., Director, Food Safety Initiatives, Food and Drug Administration, U.S. Department of Health and Human Services....................................................... 8 Margaret Glavin, Associate Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture............. 11 Michael F. Jacobson, Ph.D., Executive Director, Center for Science in the Public Interest................................. 25 Jill A. Snowdon, Ph.D., Director of Food Safety Programs, Egg Nutrition Center............................................... 27 Keith Mussman, Co-Owner, Mussman's Back Acres, on behalf of the United Egg Producers........................................... 29 Harold ``Butch'' DeVries, Jr., Vice President and General Manager, Mallquist Butter and Egg Company...................... 31 Alphabetical List of Witnesses DeVries, Jr., Harold ``Butch'': Testimony.................................................... 31 Prepared statement........................................... 180 Dyckman, Lawrence J.: Testimony.................................................... 6 Prepared statement........................................... 41 Glavin, Margaret: Testimony.................................................... 11 Prepared statement........................................... 74 Jacobson, Michael F.: Testimony.................................................... 25 Prepared statement with and attachment....................... 80 Mussman, Keith: Testimony.................................................... 29 Prepared statement........................................... 169 Potter, Morris E.: Testimony.................................................... 8 Prepared statement........................................... 55 Snowdon, Jill A.: Testimony.................................................... 27 Prepared statement with and attachment....................... 122 APPENDIX ``The Incredible Edible Egg, A Natural For Any Foodservice Operation,'' by the American Egg Board, submitted by Ms. Snowden........................................................ 151 Food Animal Concerns Trust (FACT), prepared statement............ 190 L. John Davidson, Pasteurized Eggs, L.P., Laconia, New Hampshire, prepared statement............................................. 211 Letter from Lawrence J. Dyckman, Director, Food and Agriculture Issues, GAO, dated July 22, 1999, in response to the letter dated July 14, 1999 from Senator Voinovich..................... 217 Questions and responses for Morris E. Potter, from Melinda K. Plaisier, Interim Associate Commissioner for Legislation, Department of Health and Human Services........................ 218 Questions and responses for Margaret Glavin, from Thomas J. Billy, Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture...................................... 223 EGG SAFETY: ARE THERE CRACKS IN THE FEDERAL FOOD SAFETY SYSTEM? ---------- THURSDAY, JULY 1, 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 10:08 a.m., in room SD-342, Dirksen Senate Office Building, Hon. George V. Voinovich, Chairman of the Subcommittee, presiding. Present: Senators Voinovich and Durbin. OPENING STATEMENT OF SENATOR VOINOVICH Senator Voinovich. Good morning. Unfortunately, Senator Durbin and I--and anybody else who is here--are going to have to excuse ourselves around 10:45. We have to go down and cast a vote, and we will adjourn the hearing at that time and rush back so we can continue with the hearing. We call this morning's hearing ``Egg Safety: Are There Cracks in the Federal Food Safety System?'' The Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia is going to focus on the Nation's egg supply and the extent to which the Federal food safety infrastructure is adequate or inadequate to ensure that the eggs we eat do not pose a health risk. I would first like to address the health risk posed by eggs which has prompted greater scrutiny of egg inspection practices. That risk is Salmonella enteritidis which, for the sake of ease, I propose we refer to as ``SE'' for this hearing. This bacteria is a relatively new threat, and it was only identified as a public health problem in 1988. Apparently, there has been a mutation in the Salmonella bacteria, and SE can now be passed directly from hens to their otherwise healthy-looking eggs. According to the Center for Disease Control, not all hens infected with SE pass it on to their eggs, and the number of eggs thought to be infected is one in every 20,000, or 3.4 million out of 67 billion eggs produced in this country every year. I am sure that there may be some other statistics, but those are the ones that we are using. This has created a health risk in eating undercooked or raw eggs that simply did not exist before. Eating an infected egg does not always result in illness. Proper refrigeration limits bacterial growth, and cooking eggs at 160 degrees Fahrenheit destroys SE. For illness to occur, eggs must be contaminated at the farm or during processing and then handled improperly, inadequately refrigerated, undercooked, or consumed raw. Since the late 1980's, the number of SE cases grew until it peaked in the mid-1990's and has declined somewhat since then. The Center for Disease Control estimates that in 1997, the last year from which accurate figures are available, over 100 deaths and 300,000 illnesses were attributable to SE contracted through infected eggs. My wife contracted Salmonella when she was overseas, and you get very, very sick with it. And so if you talk around 300,000, that is 300,000 pretty sick people, and we were worried about her. The segments of the population most at risk from SE are, of course, the very young, senior citizens, and individuals with deficient immune systems. Between 1985 and 1998, approximately 68 percent of deaths attributable to SE occurred among nursing home residents. They are the most vulnerable. A cursory glance at the current oversight system for egg safety would seem to indicate that it is indeed fragmented. The question for the Subcommittee is to determine whether the fragmentation is affecting the safety of our Nation's egg supply. Four agencies within two separate Federal Departments have jurisdiction at different times over eggs during the production and distribution cycle. There are many specific examples of this that will be discussed by witnesses from the General Accounting Office and others here today. In addition, most of the 50 States split responsibility for egg safety between their health and agricultural services, and, finally, private industry polices itself. My understanding is that the egg industry has taken the threat of SE seriously, and has implemented some measures to mitigate the risk. So often we think that the only way that we can have good health and safety is that it has to be regulated, but I think conscientious people that are in the business are doing what they can internally to do the job. Therefore, it seems to me that there are three important questions which we have to answer today. One, from a good government point of view, how can the current egg safety system in this country be better organized and managed; i.e., can you do a better job with all the agencies that are out there? Are they doing the job that ought to be done? We will start with that. Second, do the health risks of SE warrant going in and saying that the current system, even if it was improved substantially, is inadequate to get the job done, and that we should reorganize and combine and so on? And last, but not least, are there some short-term things that need to be done? In other words, is there, within the current framework, something that can be really zeroed in on that can deal with this problem and substantially reduce the threat of SE? Hopefully, we are going to get some answers from the witnesses here today. I am sure they have a little different point of view, and that is why we have you here. I would now like to yield to the distinguished Ranking Member of this Subcommittee, Senator Durbin, for an opening statement, and I must tell you that if it wasn't for Senator Durbin, we wouldn't be here today. He has spoken to me often about the importance of this reorganization, and he has been here a lot longer than I have and it has been a passion with him. Senator Durbin, I am sure you have an opening statement that will underscore why you are so concerned about this situation. OPENING STATEMENT OF SENATOR DURBIN Senator Durbin. Thank you, Chairman Voinovich, for doing this, and I believe that your cooperation demonstrates that this is truly a bipartisan issue. We are all interested in food safety, Democrats, Republicans, Independents alike. And the fact that this hearing is taking place clearly indicates your level of interest. What really precipitated it was this GAO study, and we will hear a lot about it today. If you stacked all the GAO studies produced each year, it probably would reach the height of the Washington Monument. They are important, requested by Members of Congress in most instances to look into various problems. But, unfortunately, most of them go unread and unheeded. This is an exception. It is an exception because we learned as late as yesterday, just a few days after this report came out, that the administration has announced that it got the message, that it is going to start making some dramatic changes when it comes to the question of food safety involving eggs. I am glad to see that, and I am happy that the Clinton administration has been responsive on the food safety issue, and I hope that they will stick with us. There is more to be done, and I hope that we can continue on a bipartisan basis to achieve it. Let me say at the outset, before we say anything else, eggs are a wholesome, nourishing, and economical food. Let me add this: Everyone I have spoken to in the government levels, from the agencies as well as the General Accounting Office, has said that the people in the egg industry have been cooperative throughout this whole effort. That is an encouraging thing, and I hope that that spirit of cooperation will continue today not only through the hearing but as we talk about ways to improve the safety of this important food product. Eggs are perishable. They need to be handled with care. And perishable products always have a degree of risk, but the risk is manageable. This issue of foodborne illness when it comes to eggs was really dramatized last year by a program on television, ``Dateline,'' which focused on some things that were being done by egg handlers and packagers which, frankly, are unacceptable. And I think that this report and this debate and this Subcommittee hearing will move us forward, and I want to commend the folks at ``Dateline'' for bringing this matter to national attention, at least to a higher level of national attention. Now, make no mistake, America has been blessed with one of the safest food supplies in the world. But we can do better. Foodborne illness is a significant problem, as the Chairman has said. GAO estimates 81 million people will suffer food poisoning each year and 9,000 will die. Children and the elderly are especially vulnerable. There is a threat from emerging pathogens such as Salmonella enteritidis--and I hope one of us has pronounced it right, I am not sure; I will call it ``SE,'' too, so it gets us both off the hook--which was virtually unheard of before the mid-1980's. How big a problem is this? Let me show you some headlines from the Richmond, Virginia, newspaper. And this is not an old story. Unfortunately, it is a new story, June 12, 1999: ``Salmonella-tainted eggs at a popular restaurant in Richmond, Virginia, were determined to be the cause of a recent outbreak of foodborne illness that left 7 people hospitalized, 92 with documented Salmonella infection, and nearly 200 people claiming illness late May,'' according to the Richmond Times-Dispatch. The restaurant chain involved here learned their lesson and announced when they were reopening that they were going to be extremely careful in using pasteurized and processed eggs that would avoid Salmonella contamination. But that is why this is a real problem. Statistics can be pushed back and forth by both sides, but I think everybody understands that we want to increase consumer confidence in our entire food supply, and certainly when it comes to eggs. In terms of medical costs and productivity losses, foodborne illness costs the Nation $37 billion a year. The Department of Health and Human Services predicts foodborne illnesses and deaths will increase 10 to 15 percent over the next decade. American consumers spend about $617 billion a year on food, $511 billion spent on foods grown here in the United States and the rest imported. Our ability to assure that the safety of our food and to react rapidly to potential threats to food safety are in the forefront of our consideration are critical not only for public health but also for the vitality of both domestic and rural economies and international trade. I would like to address for a moment the issue of consumer confidence, and I would like folks to put it in the context of what is going on in Europe today. Many of you followed the dioxin crisis in Belgium which literally closed down their food industry. Days before the national election, eggs, poultry, beef, pork, and dairy products were pulled from the shelves in Belgium. Countries worldwide have restricted imports of eggs, chickens, and pork from the European Union. Part of the controversy in Europe is the failure of government to win the confidence of consumers. People lose confidence and panic unnecessarily when their government doesn't step up to meet 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 assures consumers and makes our products more acceptable here and abroad. Everyone shares that responsibility in ensuring food safety--Federal, State, Local Government, industry, and us as well, the consuming public. The administration stepped forward on the issue of food safety, and I commend President Clinton and Secretaries Glickman and Shalala for their leadership. I want to acknowledge as well the list of accomplishments by agencies represented by Dr. Potter and Ms. Glavin today. Although in today's hearing we will examine egg safety, where much work remains to be done, I want to commend the dedication of the professionals in both departments and our Federal agencies who are committed to improving the safety of the food supply. Industry and State Governments also have a record of which we can be proud. It is clear the egg industry has stepped forward itself and taken the lead in developing such things as quality assurance programs. I want to work with the United Egg Producers to solve the challenges we face, and I ask for their input in developing legislation. How well is our government managing the safety of food from farm to table? Currently, the Federal food safety system is fragmented with at least 12 different Federal agencies and 35 different laws governing food safety, 28 different House and Senate subcommittees with food safety jurisdiction. It is no surprise with this overlapping jurisdiction that there is lack of accountability. An example of this, of course, is the FDA and USDA regulating eggs, which is the focus of today's Subcommittee hearing. Last summer, I asked the General Accounting Office to evaluate how well the Federal Government was doing. GAO has completed the report which I mentioned earlier. It shows gaps, inconsistencies, and inefficiencies. What is even more disturbing is to discover, in the absence of uniform Federal regulation, that States have established their own, creating a patchwork of varying regulations. This was a difficult undertaking for our staff, but we tried to map each State's different egg safety regulations. We couldn't put it all on one map. They are so different and so diverse. Marianne, if you will show the two different maps, we can get into this later, but the State laws are all over the place. And I think it argues for a consistent national standard based on good science and consumer food safety. Later this month, the Subcommittee will have a hearing on creating a single independent food safety agency, an idea which my colleagues and I have introduced in legislation, the Safe Food Act of 1999. But GAO has been unequivocal in its recommendation for consolidating Federal safety programs, and those recommendations go back perhaps to 1977 or before. This has been an issue even before this Subcommittee which goes back 2 or 3 decades. The fragmented Federal regulatory structure remains an obstacle to a comprehensive, consistent, and effective food safety and egg safety strategy. I welcome the witnesses and their insights. The GAO report is excellent, and I thank you for the good work that you put into it. In the coming weeks, we will try to develop legislation that takes some of your recommendations. Thank you, Mr. Chairman. Senator Voinovich. Thank you, Senator Durbin. I think that the public should understand that this Subcommittee's title is the Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia. Senator Durbin and I have talked about it, and we are going to really try and follow up on the responsibilities of this Subcommittee and pay particular attention to the GAO studies that have been done so that we can get at some of these things that for a long time have been just laying on the shelf. This Subcommittee's Chairman had several hearings with the Department of Energy. The thing that really was striking to me is every single year they came back with a report saying there is a problem, there is a problem, there is a problem, and nothing was done about it. And now we are back at it again. Hopefully, that will be taken care of. So I think, Senator, that you have raised a real issue, something that has been around for a while, and I think we ought to attack it and make a decision. We are lucky to have such good witnesses here today. First of all, I would like to introduce our first panel of witnesses: Larry Dyckman is the Director of Food and Agriculture Issues at the U.S. General Accounting Office. Good to have you here. Ms. Margaret Glavin is the Associate Administrator, Food Safety and Inspection Service of the U.S. Department of Agriculture. Dr. Morris Potter is the Director of Food Safety, Food and Drug Administration, Department of Health and Human Services. Both are here, Dr. Potter and Ms. Glavin, on behalf of the administration. We thank you for coming, and we look forward to your testimony. I would like to start out with Mr. Dyckman. TESTIMONY OF LAWRENCE J. DYCKMAN,\1\ DIRECTOR, FOOD AND AGRICULTURE ISSUES, U.S. GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY STEVE SECRIST, SAN FRANCISCO REGIONAL OFFICE Mr. Dyckman. Good morning, Mr. Chairman, Senator Durbin. With me today is Steve Secrist from our San Francisco regional office. He is a senior evaluator who has been responsible for much of the work that I will be talking about today. --------------------------------------------------------------------------- \1\ The prepared statement of Mr. Dyckman appears in the Appendix on page 41. --------------------------------------------------------------------------- We want to thank you again for the opportunity to discuss our work on the safety of eggs and egg products. My testimony, as you know, is based on a report we are issuing today to Senator Durbin. Eggs are an important part of most American diets. I might tell you that my wife eats several eggs a day. She watches her cholesterol and she eats the egg whites, but she enjoys them very much. On average, each American consumes about 245 eggs annually. But over the last decade, eggs contaminated with Salmonella enteritidis bacteria, which we will all refer to as ``SE,'' have increasingly been implicated as the cause of foodborne illnesses in the United States. SE may have caused about 300,000 illnesses in 1997, according to the CDC, resulting in up to 230 deaths. Most SE outbreaks with identified causes are linked to eggs. The Senator spoke about the case in Richmond. We have been in touch with the Virginia State officials, and they have 121 confirmed cases of illnesses connected to SE infection. And they believe eggs are the likely cause of those infections. It is important to note at the onset that responsibility for ensuring that eggs are safe to eat is shared among four Federal agencies and two departments, and often two agencies in each State. As the blue exhibit shows, the process begins under the authority of USDA's Animal and Plant Health Inspection Service, which ensures that egg-laying hens are bred free of SE, and continues under the authority of FDA, which is responsible for egg safety on farms where eggs are produced. That chart is on page 5 of the written testimony. It is also in our blue book report if it's difficult to follow for people in the room. At the processing stage, either FDA or USDA's Food Safety and Inspection Service may have authority, depending on whether the eggs are sold whole in the shell or broken to create an egg product. Shell eggs may also be graded for quality by another USDA agency. Once transported to the retail level, both shell eggs and egg products are under FDA's authority, but the millions of restaurants, institutions, and other retail food operations throughout the United States are generally inspected by either a State agriculture or health department. The number of agencies involved is a key factor in the problems documented by our review. Clearly, the egg situation is a case study of the cross-cutting and duplicative problems that we have reported to this Subcommittee and to many other committees in our series on major management problems and challenges facing government agencies. It was also reported as a major management problem concerning food safety in general in our report concerning the Department of Agriculture. Our work in this particular review found that neither FDA nor USDA requires the egg farms and processing plants under their authority to use a prevention-based approach that would identify control and monitor known safety risks. Over the last few years, the Federal Government has introduced such programs referred to as Hazard Analysis and Critical Control Point systems in meat, poultry, and seafood processing. At the State level, 13 States responsible for about two- fifths of the Nation's egg production have established voluntary prevention-based programs for egg farms. However, these programs differ in critical areas such as when and how to test for the presence of SE. Although refrigeration retards the growth of SE, our work found that the first national requirement to refrigerate eggs at 45 degrees or colder from the time they are packed until they reach the consumer may not, for a variety of reasons, effectively reduce safety risks. The responsibility for implementing and enforcing the requirements will be split between USDA and FDA. USDA has issued regulations which will take effect later in August requiring that eggs be refrigerated during storage and transportation. We found out today, actually, that FDA is in the process of proposing regulations for retail locations, restaurants, and grocery stores, and we are encouraged by that. We haven't seen them yet, but it is good to hear that they are on their way. In addition, many experts believe that safety risks could be better reduced by controlling eggs' internal temperature. The regulations will focus on air temperature rather than on the internal temperature. Yet eggs are often in the 70- to 80- degree range when they are processed and packed, and it may take up to 6 days before the internal temperature is reduced to the air temperature in the cooler. Our work also found inconsistent policies and practices in three other areas. Certain groups, including the elderly in nursing homes, are more likely to suffer severe health consequences from eating contaminated eggs. Yet only about half the States have followed FDA's recommendation that they require food service operators to use pasteurized eggs or egg products when serving vulnerable populations. Also, Federal policies allow some eggs, as we have learned from the ``Dateline'' news show, to be returned from grocery stores for processing to be repackaged, re-dated, and returned to the retail level for sale. Moreover, Federal rules on how expiration dates are used on eggs vary considerably. Finally, we found that the involvement of the four Federal agencies enforcing a variety of laws make it difficult to direct resources to the greatest safety risk or to effectively coordinate egg safety policies. For example, USDA by law provides daily full-time inspection of plants where eggs are pasteurized to kill harmful bacteria, whereas FDA almost never inspects egg farms where eggs can be contaminated. Mr. Chairman, in your invitation to me, you posed a question, and I would like to answer that question right now, and the answer is: Yes, the Federal food safety program for eggs is cracked, disjointed, it is duplicative, and it is not always risk-based. We are offering some recommendations that we think will address those problems. First, to address the need for a consistent farm-to-table approach to egg safety, the report we are issuing today asks the Congress to consider consolidating responsibility for egg safety in a single Federal Department. We are also recommending: First, that FDA develop a model prevention-based program for egg farms and processing plants which States can adopt to reduce the risk of SE contamination; second, that the USDA develop regulations that would require prevention-based programs at plants where egg products are processed; and, third, that USDA and FDA jointly study the cost and benefits of implementing rapid cooling techniques in egg processing and packaging operations. In commenting on our draft report, USDA and FDA generally agreed with our recommendations. We would be happy to answer any questions you or Senator Durbin have. Thank you. Senator Voinovich. Thank you very much. I would like to remind the witnesses that their entire statements are going to be entered into the record, and to the best of their ability, if they could limit their statements to 5 minutes, it would be most appreciated. We will now call on Dr. Potter for his testimony. Dr. Potter? TESTIMONY OF MORRIS E. POTTER, D.V.M.,\1\ DIRECTOR, FOOD SAFETY INITIATIVES, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Mr. Potter. Thank you, Mr. Chairman, and Senator Durbin. I am Morris Potter, Director of Food Safety Initiatives at the Food and Drug Administration, and I am pleased to be here with my colleague, Maggie Glavin, from USDA to testify on the government's role in the oversight of egg safety and to describe how we have applied science to protect the public's health. --------------------------------------------------------------------------- \1\ The prepared statement of Mr. Potter appears in the Appendix on page 55. --------------------------------------------------------------------------- HHS, USDA, and the States have a long history of working together to understand and initiate actions along the farm-to- table continuum to reduce the risk of SE. Federal surveillance and research efforts have been critical to our better understanding of SE and efforts to develop science-based control schemes from farm to table. In the early 1980's, routine public health surveillance identified SE as a growing public health problem, as you see in the first part of that upper figure. In 1986, outbreak investigations linked this growing problem to contaminated whole shell eggs. FDA, CDC, ARS, APHIS, and AMS immediately responded by working together and with State Governments, universities, and the egg industry to conduct research and to put into place prevention and control mechanisms as that information developed. To control a public health problem like SE in eggs, one must first understand it. Surveillance of human illness, laboratory research at ARS, FDA, and universities, and field investigations have all been essential to that understanding. Data from CDC's Salmonella surveillance system show that SE infections increased more than 8-fold from 1976 to 1996, as you can see by making a composite of that top--the lines in the top figure. Another valuable data source early in the outbreak was the surveillance of outbreaks of infections with SE. States reported 26 SE outbreaks in 1985 when that surveillance system started. By 1990, the number of reports had increased to 85. There were strong regional differences in the number of outbreaks just as the chart reflects strong regional differences in the number of infections. Many SE outbreaks have been attributed to food served in commercial establishments, such as restaurants, hospitals, schools, nursing homes, and most were associated with food that contained undercooked eggs. Most deaths linked to reported outbreaks have occurred among the elderly in hospitals and nursing homes. These two characteristics, the association with undercooked eggs and commercial establishments, emphasized the importance of nationwide adoption and enforcement of FDA's Food Code which first focused attention on proper egg handling in 1990. The Food Code contains special guidance for food handling in institutions to try to reduce the risk particularly for those vulnerable populations. The Federal agencies have collaborated on a number of additional efforts to improve institutional food service handling of eggs. In addition to epidemiology, our public health response to SE in eggs has relied heavily on laboratory science and field investigations. Design of on-farm control programs required understanding the organism and its mechanism of action as well as comprehending the natural history of SE's introduction, spread, and persistence in the environmental of a laying house. Universities, States, and industry have conducted many of the field studies. Since October 1995, FDA has traced eggs from 12 outbreaks back to flocks of origin, additionally leading to field investigations of 112 laying houses in 9 States. Various control programs have been tried showing that combinations that include the use of uninfected replacement birds, rodent control, cleaning and disinfection between flocks, and environmental monitoring will reduce the incidence of infected flocks. Controlling SE during production is crucial in mitigating the risk of SE in eggs. Research in this area is being conducted by both FDA and ARS to uncover all important sources of the SE problem and to develop ways to maintain SE-free laying hens. As additional studies are completed, we will be able to determine more precisely which factors are critical and what performance standards must be met for optimal public health protection. Our ability to now move forward on a comprehensive program for improving the safety of eggs is a direct result of the investments in research during the past several years. We can also use surveillance to track the public health progress we are making to control SE in eggs. As you see in the chart, SE infections have been dropping since 1996, especially in the Northeast where control efforts began first and have been most intense. The data also indicate a downturn in commercial establishments and the average size of outbreaks. In 1995, FDA, CDC, FSIS, and five State health departments began a collaborative project or program called FoodNet to collect more precise information on the incidence of foodborne disease. FoodNet recently reported a 44 percent decrease in the infection rate for SE from 1996 to 1998 in the areas of the country under surveillance, and you see that in the bottom figure there on the chart. Collectively, these systems report substantial decreases in SE during the past 3 or 4 years. We believe that these data show that the coordinated efforts of all of those involved in the farm-to-table handling of eggs contributed to this dramatic decrease in illness, including Federal agencies, State governments, the egg-producing industry, retailers and food service, and consumers. Federal and State efforts to trace back from outbreaks to infected flocks and to establish egg quality assurance programs that include microbiological testing and diversion of eggs from infected flocks to pasteurizing plants have been important factors in this reported decrease, and we will continue to work collaboratively to further reduce the prevalence of SE in laying hens. But just as these data on the chart demonstrate progress in the control of SE, they also document a very large public health challenge that remains to be overcome. We need to finish the job we started for the public. The joint FSIS-FDA risk assessment made it clear that all of the steps from the farm to table can contribute to egg safety, and we will consider all possible measures to achieve our public health goals. As you know, FDA has been working on a proposed rule to address refrigeration and labeling of eggs that is consistent with the requirements of the FSIS rule. FDA's proposed rule was put on public display today. It proposes requirements that all shell eggs be stored and displayed at temperatures of 45 degrees or less, and it would cover shell eggs both in interstate and intrastate commerce. It proposes safe handling statements on the labels of shell eggs. In addition, the President's Council on Food Safety will create within 120 days a farm-to-table approach for addressing SE in eggs. This will be part of the Council's overall strategic plan for food safety that should come out early next year. Information from recent research, the joint FDA-FSIS 1998 Salmonella Risk Assessment, and the comments we received on the joint FDA-FSIS ANPR of May 19, 1998, intended to identify farm- to-table actions that will decrease the risk of SE in shell eggs will be used by the task force to help finalize its recommendations for a strategic plan for a comprehensive system for the safety of eggs and egg products. Mr. Chairman, there clearly are complex lines of jurisdiction over eggs between FDA, FSIS, and AMS. Those lines, however, are not cracks in the system but seams. We have a long history of coordinated effort to address the public health challenges we face in SE in eggs. Much has been done to address those challenges but more, indeed, is needed. We are committed to provide the country with a seamless coordinated farm-to- table policy. Thank you very much. Senator Voinovich. Thank you, Dr. Potter. Ms. Glavin. TESTIMONY OF MARGARET GLAVIN,\1\ ASSOCIATE ADMINISTRATOR, FOOD SAFETY AND INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE Ms. Glavin. Mr. Chairman and Senator Durbin, I am Margaret Glavin, the Associate Administrator of the Food Safety and Inspection Service. I am pleased to appear with Dr. Morris Potter, my colleague from FDA, to discuss the safety of eggs and egg products in general, and specifically to discuss the egg products inspection program of the Department of Agriculture. Because several agencies at USDA play a role in egg safety and regulation, I am joined today by Michael Holbrook of the Agricultural Marketing Service, Dr. Jane Robens of the Agricultural Research Service, and Dr. Thomas Myers of the Animal and Plant Health Inspection Service. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Glavin appears in the Appendix on page 74. --------------------------------------------------------------------------- Let me begin by emphasizing USDA's commitment to improving the safety of the food it regulates--meat, poultry, and egg products. Over the past several years, USDA has implemented a strategy for change that emphasizes the need to prevent food safety problems before they happen and the need to address food safety hazards all along the farm-to-table chain. FSIS has a long history of inspecting meat and poultry products, but the agency's involvement in egg products inspection is relatively new. The USDA Reorganization Act of 1994 set the stage for FSIS involvement in egg products inspection by transferring this responsibility from the Agricultural Marketing Service to the Food Safety and Inspection Service. Under the Egg Products Inspection Act, FSIS is responsible for continuous Federal inspection in plants processing liquid, frozen, and dried egg products. During fiscal year 1998, 102 FSIS inspectors monitored operations at 73 egg product plants across the country. We also have cooperative agreements with six States to provide inspection of egg products. Additionally, FSIS oversees the importation of egg products into the United States. I understand the concerns of the current statutory framework for egg safety presents a fragmented system of oversight. I do, however, want to make two points: First, that USDA activities regarding shell eggs and egg products go beyond FSIS--and that is what my chart indicates--and any effort to adjust the current statutory framework for egg safety should consider the broad range of activities carried out by the Department. The second point--and it echoes Dr. Potter's remarks--is that FSIS and FDA, which share statutory authority for egg safety, have worked closely together and are making progress in developing a coordinated approach to the problem of SE in eggs and egg products. Let me first address the broad range of USDA activities beyond FSIS by providing a few examples. The Agricultural Marketing Service administers a voluntary grading program for shell eggs and is responsible for the shell egg surveillance program. AMS last year announced a prohibition on the repackaging of eggs packed under its voluntary grading program while it studied the issue further, and that agency is now working on a proposed rule to address this matter more fully. The Animal and Plant Health Inspection Service conducts activities related to animal health, and several of its activities have a public health impact by reducing the risk of disease in layer flocks. For example, APHIS administers the National Poultry Improvement Plan, which certifies that poultry breeding stock and hatcheries are free from certain diseases. The Agricultural Research Service and the Cooperative State Research, Education and Extension Service carry out needed food safety research that helps us to improve the safety of eggs and egg products. And USDA agencies play a role in educating consumers about the safe handling of eggs. FSIS has developed numerous publications on egg safety and uses a variety of networks to get this information to the grass-roots level, including the network of the cooperative extension agents throughout the country. Regarding the second point, that FSIS and FDA are working together to address the problem of SE in eggs and egg products, I would like to provide two examples. In May 1998, FSIS and FDA jointly issued an Advanced Notice of Proposed Rulemaking to initiate a comprehensive and coordinated process of addressing the problem of SE in shell eggs and to solicit input from the public on the strategies. And FSIS and FDA have conducted a joint quantitative farm-to-table risk assessment on SE in eggs that was released last summer. The risk assessment is helping us to better evaluate interventions in terms of their public health impact as we further develop our food safety strategy for shell eggs and processed eggs. These joint initiatives complement and provide a framework for other initiatives taken by FSIS. For example, in August 1998, FSIS published a final rule to implement the requirement for the refrigeration and labeling of shell eggs that were mandated by the 1991 amendments to the Egg Products Inspection Act, and FSIS is now developing a proposed rule that would address HACCP for egg products. For the future, more progress is needed, and to facilitate that progress a strategic plan for shell eggs and egg products is being developed by the strategic planning task force of the President's Food Safety Council. It will be completed within 120 days and will parallel the broader strategic planning effort that is already underway by the Council. We have certainly not won the war against foodborne illness by any means, and eggs remain a major source of SE illness. But the steps we have taken with HHS are making a difference, and we are committed to further progress. This concludes my testimony, and I thank you for the opportunity to be here today with FDA to discuss the safety of shell eggs and egg products. Senator Voinovich. Thank you very much. We decided, in order to move the hearing along, that Senator Durbin will go and vote, and I will ask my questions, and when he comes back, he will ask his, and hopefully they will not be the same questions. Obviously, the General Accounting Office feels that the organizational structure leaves something to be desired, and I would like to call on Mr. Dyckman. You have heard the testimony, and I would like to have you comment on what you have heard this morning. Does that color your judgment on this matter? Mr. Dyckman. I appreciate the opportunity, Mr. Chairman. Egg safety is a microcosm of food safety. We have been on record for many years, as Senator Durbin pointed out, supporting consolidation of all food safety efforts in the U.S. Government. And if we had our druthers, that would occur and egg safety would be part of that consolidation. We recognize that there are political, social, economic, and other kinds of implications of doing that, and it may take time before that occurs, if it ever occurs. In the interim, we have known about the problem with egg safety for 11 years. We reported in 1992 that there is a need for a much better, closely coordinated effort, a common strategic plan for egg safety. I am encouraged and heartened that either the work that we have done or maybe it is just time that the two primary agencies are coming together and seemingly working for that plan. However, look at our food chart up there; it took me quite a while to understand this chart. This review has been my first exposure to egg safety, and I kept asking my staff, now, let me get this straight: Why does FDA have responsibility on the farm? Why does Agriculture have a responsibility for the egg product plants? Who has responsibility for refrigeration at this point and at that point? Why do they have differing labeling requirements? Why aren't there HACCP-like procedures, HACCP-like systems required at different points? Why isn't the entire system risk-based? And while I am encouraged by what I hear today, GAO still believes that there is a need to consolidate egg safety responsibilities in one Federal agency. Senator Voinovich. And that is just one of the things. You are basically recommending that we have food safety consolidation, period, and that one of the reasons is the issue of egg safety, but there are many other areas that you feel could be better addressed if you had a consolidation of those agencies. Mr. Dyckman. That is correct. If there was one agency that had budgetary authority over the Federal Government's food safety programs, one agency that had authority or one official that had authority over the research that is done on food safety, I think it would be a lot more efficient. I think we would be able to accomplish more as a agency, as a country. Now, we have among the safest food safety systems in the world. But I think we can accomplish more and it would be a much more efficient system if there was one Federal agency that had all responsibility for food safety. I understand you might be having a hearing on that later this month, and we would be happy to help you with that hearing. Senator Voinovich. From your observations, what role should the States be playing in this? Mr. Dyckman. In egg safety? Senator Voinovich. Yes. Mr. Dyckman. I think it is quite clear that at the retail level in particular, and also at the farm level, the Federal Government doesn't have the resources to police, to monitor all establishments or even a large fraction of the establishments. I think the Federal Government has to set minimum policies and then allow States to develop a more stringent or equal to Federal minimum policies, whether it is a HACCP-type program at the farm level or a HACCP-type program at the shell egg processing plants. Obviously, many States are moving in that direction. We noted that there are 13 States that have some type of HACCP- type program. We are encouraged by that. Some of those are relatively new, so it is a little too early to evaluate their effectiveness. States want to work, I believe, as equal partners with the Federal Government, and I think that is the way it should be. Senator Voinovich. In your report are you specific in terms of the responsibilities that the Federal Government would have and where the States' responsibilities would be? Mr. Dyckman. Our report mentions the States' responsibilities. It doesn't go into a lot of detail in terms of how they should interplay with the Federal Government in the future. Clearly, regarding our recommendation for the Federal agencies to come up with a HACCP-like program or requirement and model for the farms and for the egg-processing plants, there will have to be a partnership on the State level to enforce that because the Federal Government will never have enough resources to enforce it. Senator Voinovich. So what you are saying is that there definitely is a role for the States to be playing. Mr. Dyckman. An equal role, a very strong role. And, a lot of this commerce is interstate commerce where the Federal Government has a clearly defined role. Where it is intrastate commerce, obviously the States generally have a much stronger role and the upper hand. Senator Voinovich. In your report, did you note any State out there that--you referred to 13 States that have started HACCP programs. Is there a ``best practice'' State out there? Mr. Dyckman. I will ask Steve to comment on that. Senator Voinovich. Yes. Mr. Secrist. I think Pennsylvania--back in the early 1990's, Pennsylvania was part of a pilot project along with the Animal and Plant Health Inspection Service to look at SE reduction measures, and then that pilot project ended, but it became what is now the Pennsylvania Egg Quality Assurance Program, and that was one of the first, probably the first comprehensive SE reduction program at the State level. And subsequent to that, other States have adopted similar measures. California and some of the other states that we have mentioned have taken elements of that plan and developed their own plans. Pennsylvania would be a good model to look at. Senator Voinovich. Well, as a former governor and chairman of the National Governors Association, one of the things that I always felt could be improved was the relationship between the Federal Government and State Government in this whole regulatory area, and that the idea of sharing best practices, getting the directors of the Agriculture Departments together to talk about best practices, to see if you couldn't cascade them throughout the country, would be a good idea. I think that perhaps coming out of this we could be in touch with the Governors Association to see if we couldn't improve their coordination, since at least you acknowledged that they have a role to play here. And I would be interested also, Dr. Potter and Ms. Glavin, in your opinion of that. We have heard an argument, and it has been around, on reorganization. Why not? The system that we have currently--can it get the job done? Ms. Glavin. Our focus at this point is very much on identifying those actions which would include such things as regulation and research that need to be done in order to improve egg safety, and we are focused on that rather than on the organizational issue at this point. We think there is a lot to be done and a lot that can be done even under the existing structure. Mr. Potter. Just to amplify that, I absolutely agree with what Maggie said, but each of the Federal agencies brings to the mix its own set of skills that are garnered over the years due to its involvement in all of the things that it does in addition to its specific role in the farm-to-table pathway of eggs. And our efforts to pull together that expertise and those resources, the intellectual capital of the Federal agencies to bring to bear on a problem I think has shown itself valuable. We are committed to a single food safety framework, and I think that the collaboration among the agencies is starting to show a measure of progress in achieving our public health goals. There is a strong role for States in food safety for a number of reasons. As GAO pointed out, there is a great resource issue for the Federal agencies to get out to individual establishments, be they producers or restaurants, but also there is a relationship, as you know, that builds up between the State agencies and the producers and businesses in the States that can help facilitate communication and speed adoption of good practices. Senator Voinovich. I am going to have to excuse myself, and hopefully Senator Durbin will return to the hearing and he will bring it back into session. But when I get back, I would like to hear from both of you. We do have the Results Act, and you have performance plans that you have put together, and I would be interested to know how much coordination in this particular area has gone on between your two respective agencies. I will be back. [Recess.] Senator Durbin. If we could ask everybody to resume, I am going to try to pick up where Senator Voinovich left off. Thank you very much, and I apologize for the interruption. But we had a vote on the floor, and Senator Voinovich will be back very briefly. I tried to ask my staff to recount briefly the Chairman's questions, and I hope I don't go over the same ground. I apologize if I do. I would like to ask the GAO and other witnesses present if they will bear with me for a minute, or 2 minutes, maybe, to go through a primer so that we understand what we are talking about here. It is my understanding that this contamination, this SE contamination, can be detected in chickens before the eggs are laid. Is that true? Mr. Dyckman. Yes. Senator Durbin. All right. It is also my understanding that the incidence of this contamination in eggs depends on a variety of factors. One of them, of course, is whether it was initially contaminated, which we will assume for a moment that is a possibility. The other is the age of the egg. Is that not true? Mr. Dyckman. That is correct. Senator Durbin. And what kind of standards have you found in your investigation in terms of the vulnerability of an egg to contamination? Can you give us any standard? Mr. Dyckman. What we have found is that there is no HACCP- based system at the farm level in the production of the eggs and also at the processing plants. It is not really a risk- based system. Now, some farms obviously do follow better sanitary practices than others. Senator Durbin. My question wasn't clear. What I am asking for is on the age factor. How old is an old egg? When do you start getting into the time frame of an egg's age where it is more susceptible to contamination? Mr. Dyckman. First, let me say at the onset I am an accountant, not a scientist, but if you will bear with me, I think it is about 21 days or so. Senator Durbin. That it is more susceptible to contamination. Now, I read 30 to 45 days in the report. Mr. Secrist. There has been some scientific research that has been done that shows that at least in that research study they may have a natural protection against SE replicating, growing in the egg for perhaps up to 21 days. That is under certain conditions, assuming that the SE is deposited in the egg white and that it is under a certain temperature. What we have found in terms of expiration dating was that there currently are no Federal standards for expiration dating on egg cartons and that AMS under the voluntary grading program only requires a 30-day expiration date if the producer decides to use a date. They are not required to use a date, but if they do, it cannot be over 30 days. Otherwise, you can put any expiration date you want on an egg carton. Senator Durbin. When do you start counting? When is the first day? Is it the day that the chicken lays the egg? Mr. Secrist. It is the date that the eggs are packed. Senator Durbin. So there could be a period of time between the chicken laying the egg and their arrival at the packing house? Mr. Secrist. Yes, there could be. Senator Durbin. Do you have any idea what range of time we are talking about? Is it a matter of 24 hours or days or longer? Mr. Secrist. That probably varies. There are obviously in- line operations where the egg farm is co-located with the packing plant, and the eggs are coming into those plants very quickly. It is also possible that eggs might be produced and shipped to the packing plant and that could take some time. Senator Durbin. So the question of expiration, susceptibility to contamination, you really have to start off with some basic understandings and agreement. When are we going to start counting and how long will we count? Would there be disagreement from FDA or USDA on any of the points that have been made so far? Mr. Potter. I think only a point of clarification, not a point of disagreement, and that is that the eggs are contaminated before they are laid, and what we are really debating here is opportunities for growth of organisms that are already there rather than the contamination itself. Senator Durbin. Do you have a time frame where you think they are more likely to have this growth of contamination, age of an egg? Mr. Potter. The growth of the organism occurs after the yolk membrane breaks down, which is a function of both time and temperature. So as the eggs are colder and fresher, there is no growth. Where precisely--whether it is 21 days or 30 or 45 days--would be modified by the temperature the eggs are kept. Senator Durbin. And has either the FDA or the USDA established a standard for when we start counting, how many days, age of an egg? Ms. Glavin. As Mr. Dyckman indicated, the grading service counts from the day of packing for expiration. That is for eggs that are graded by USDA. Senator Durbin. And what is your experience in terms of how many days between the egg being laid and it being packaged? Ms. Glavin. Again, I would agree with Mr. Dyckman that varies depending on the kind of process that is used. Senator Durbin. So if we are going to give the consumer some peace of mind here and say, now, after 30 days you ought to think twice about cooking with that egg, we better start by understanding among ourselves, at government agencies, when we are going to start counting. If you start counting at the packing plant, there is no telling how old that egg is when it is packed. Is that not true? Let's talk about temperature for a minute, and that is another element here. If the egg is kept at a certain temperature, the likelihood of this contamination and outgrowth is diminished. Is that true? Mr. Dyckman. Yes, 45 degrees seems to be the temperature that scientists tend to agree will prevent further growth of SE. Senator Durbin. Well, I would like to follow up on that for a moment, if I might. The testimony of Dr. Potter is that there is some seamless--your word--relationship and coordination between the USDA and the Food and Drug Administration. Let's talk about the seam. In 1991, by legislation, we instructed your departments to come up with standards when it comes to the temperature of eggs, how they are going to be stored and maintained in order to protect public health. I would have to say by virtually any measure that both agencies failed in meeting that statutory responsibility to the point in 1998 where Congress had to put in your appropriation bill a mandate which said you are going to lose $5 million if you don't finally come out with this rule on the temperature of eggs. And so 8 years after Congress gave the responsibility to your agencies, that rule was finally issued. Is that true? Ms. Glavin. Yes, sir. Senator Durbin. Why did it take 8 years, a pretty wide seam by anyone's interpretation, for the rule to be issued? Ms. Glavin. Well, as you said, the law was passed in 1991, and at that time the responsibility was with the Agricultural Marketing Service, and they issued a proposal to implement the rule, the 45-degree rule, in 1992. Shortly after that, there were a number of legislative proposals to change that law, to make changes in it, which somewhat complicated the issue. In 1994, the Reorganization Act was passed, and in 1995, responsibility for egg products inspection passed to the Food Safety and Inspection Service. And as you indicated, our appropriations in 1998 told us we better get this regulation finalized, and we did do so in 1998. I think it is important to recognize that we were not sitting on our hands all that time, although I can't disagree that it was a very long period of time. We did put together a joint Advanced Notice of Proposed Rulemaking with FDA setting out a strategy for dealing with egg safety and also seeking data, mainly from the industry, on which we could make good, sound judgments about how to regulate in this area. We also completed the first ever risk assessment on bacteria in foods, and that was the SE risk assessment, and that has served us very well as we have moved forward. Senator Durbin. So it took 8 years. Ms. Glavin. Yes, sir. Senator Durbin. Eight years for the U.S. Department of Agriculture to finally conform to the requirement by Congress to establish some standard about the temperature of eggs. But the story doesn't end there because the USDA responsibility, because of this fractured jurisdiction, stops, does it not, at a certain point when it comes to the temperature of eggs? And what is that point in the process? Ms. Glavin. Well, the responsibility--or the regulation based on the legislation is for the temperature of eggs during storage and transportation. Senator Durbin. So you are not talking about when it reaches the store or the restaurant or anything of that nature? Ms. Glavin. It is until it reaches the store or the restaurant, yes. Senator Durbin. OK. And so at that point, we have a hand- off here to a new Federal agency, the Food and Drug Administration. Now, they are going to take over the question of the temperature of eggs after the USDA is finished. Is that correct, Dr. Potter? Mr. Potter. That is correct. Senator Durbin. Now, you have known for 8 years this was coming, and so what has the FDA done? What rule have you promulgated to talk about the temperature of eggs once it has reached this point of transportation to the end user? Mr. Potter. Well, that proposal is on display at the Federal Register now. It is out and it conforms to the temperature and labeling requirements of the eggs as they come to that pass-off. Senator Durbin. So you don't have an FDA final rule even after 8 years? Mr. Potter. That is correct. Senator Durbin. Now, there is another thing that I want to get to, and that is, you mentioned 45 degrees, but there is some confusion here as well. Are you familiar with your Food Code? Mr. Potter. Yes. Senator Durbin. What is it? Mr. Potter. The Food Code requirement is for 41 degrees---- Senator Durbin. Just in general, what is the Food Code, for the record? Mr. Potter. Oh, I am sorry. The Food Code is a model code for adoption by States that sets uniform standards across the country. Senator Durbin. Voluntary for each State. Mr. Potter. Right. Senator Durbin. And how many States have passed it or enacted this Food Code? Mr. Potter. At present, 14 States have adopted it, and an additional 22 are in the adoption process. Senator Durbin. And so when we look at this Food Code, we keep talking about 45 degrees. We look at the act which you have sent out to the States in terms of standards, and do we find 45 degrees is the standard? Mr. Potter. Well, remember that the Food Code is for all foods and all pathogens. For some pathogens, like Listeria, that grow at slightly lower temperatures than Salmonella, a lower temperature is more appropriate. But restaurants and other food service establishments are unlikely to have one refrigerator for things for Listeria and another for Salmonella. Senator Durbin. That is right. So what is the standard in the Food Code? Mr. Potter. The standard for retail is 41 degrees. However---- Senator Durbin. Forty-one degrees. Go on. Internal temperature. Mr. Potter. That is refrigerator temperature. Senator Durbin. Forty-one degrees internal temperature for the eggs is your Food Code standard, and the standard we have been discussing here is 45 degrees air temperature. Mr. Potter. I believe the Food Code requirement is 41 degrees ambient temperature. In other words, that would be the refrigerator temperature setting. Senator Durbin. We had a different reading on it, but let's assume that it is 41 degrees under any standard. Think about this for a second. Think about what we have just discovered. In 1991, Congress passed a law and said to the USDA and the FDA: We think the temperature of eggs is important to protect American consumers; please write some rules so that we can understand how to transport eggs, how to store eggs, so that we can best protect American consumers. Eight years pass and only when Congress says in the USDA appropriation, if you don't finally do your job, you are going to lose $5 million this year, they do it. They issue it. The Food and Drug Administration, which is supposed to pick up the baton after the transportation, then decides they have got to do it, too. Now we are waiting to see when that rule becomes final, and in the process, we find that at least there is some ambiguity, if not inconsistency, in the standard we get from these two agencies: 45 degrees, 41 degrees, voluntary, mandatory. Is it any wonder that we have this GAO report which questions whether these agencies are conducting a ``seamless coordination''? I think it is pretty clear that there are some seams and they are pretty wide. Let me talk about some other things that I think need to be talked about. Repackaging. The U.S. Department of Agriculture, after the ``Dateline'' story, came out--and I am glad they did--and said for the eggs that we grade there is a prohibition against taking old eggs off the shelf, bringing them back to the plant, packaging them with new eggs, for obvious reasons: Older eggs, more susceptible to contamination. What percentage of the eggs sold in America are graded by the U.S. Department of Agriculture? Ms. Glavin. I believe it is about 30 percent. Senator Durbin. Thirty percent. That is the figure that I have, too. So we now have a standard from the U.S. Department of Agriculture for about a third of the shell eggs that are sold in the United States, and virtually no standard, at least no Federal standard, no national standard, when it comes to all other eggs. Is that correct? Ms. Glavin. That is correct. Senator Durbin. Another indication of why we need to start talking about a national standard. If it is dangerous to a consumer not to know that they are buying a dozen eggs that might have a variety of different ages, dangerous enough for the USDA to issue a standard, then certainly it raises a question about why this danger shouldn't be a matter of concern nationwide in terms of what we accomplish. Let me also, if I can, visit for a second this question of APHIS, the Animal and Plant Health Inspection Service. They are involved in the inspection, if you will, of the actual farms where the eggs are being produced. Is that correct? Ms. Glavin. They are responsible for something called the National Poultry Improvement Plan which has to do with the health of the laying flock, yes. Senator Durbin. OK. Ms. Glavin. The breeding flock, I am sorry. Senator Durbin. The breeding flock. And you can test these chickens to determine whether or not they are contaminated with Salmonella. Is that correct? But there is no requirement that you test them under the law, is there? Ms. Glavin. No. Senator Durbin. So this is all voluntary. Ms. Glavin. Well, for---- Mr. Myers. It is voluntary, but for interstate movement or international movement, that is required. Senator Durbin. So, again, eggs that are moving between States or that are going to be sold overseas, then we test the flocks; but if they are sold in the good old U.S. of A. within a State, no standard. Is that correct? Ms. Glavin. Yes. Senator Durbin. How can that give the consumers any confidence? Do you think it does? Ms. Glavin. I think that, as we have said this morning, it is necessary to look at a range of ways of addressing this problem, which is a very serious problem and which is not solved. Senator Durbin. Well, it is clear that it is not solved, and I think, frankly, that there are some things that we need to do. How many people at the Food and Drug Administration work on egg safety? Mr. Potter. We can get you a firmer number. I don't know that. It is a little hard to calculate because there--because of the way we operate, it is not 100 percent of very many people's time, but it is a portion---- Senator Durbin. How many people devote part of their day to the issue of egg safety in America at the Food and Drug Administration? Mr. Potter. I will have to get back to you with that because it involves our field staff, and I just don't know what those numbers are. Senator Durbin. What did the General Accounting Office find when it looked into how many people at the various agencies-- U.S. Department of Agriculture and the Food and Drug Administration--were involved? Mr. Dyckman. Well, we know that there are about 102 inspectors at FSIS. Senator Durbin. The U.S. Department of Agriculture? Mr. Dyckman. The U.S. Department of Agriculture. When I asked our staff how many people at FDA, I believe they could remember one person that has an egg responsibility on a full- time basis. Mr. Secrist. Yes. Mr. Dyckman. There were other people involved, but that is all we could identify. Senator Durbin. And this agency, the Food and Drug Administration, which you found one person to be working on a full-time basis, has a responsibility for so-called shell eggs, those eggs that have not been broken. What is the volume of shell eggs in the United States each year? Mr. Dyckman. It is 70 percent of 67 billion. Senator Durbin. So it is in the 40 billion range? Mr. Dyckman. It is up there. Senator Durbin. I think in our conversation you also indicated that most of the FDA response you found to be after the fact. If there had been evidence of some foodborne illness, there was an attempt by the FDA to trace its source? Mr. Dyckman. Right. Their primary responsibility seems to be a trace-back responsibility, not a preventative type responsibility. Senator Durbin. That is a point which I think is very important here, and, Dr. Potter, I would like to give you a chance to respond to that as well. But every indication I have--first, let me say this: The Food and Drug Administration is one of my favorites. It is one of the most important agencies in the Federal Government. Dollar for dollar, we get more out of the FDA than virtually any agency, $1 billion a year we spend there, and we rely on them every time we turn around, for medical devices, pharmaceuticals, and a wide range of things. Such an important agency that we should pay more attention to it and devote more resources. Having said all that, after I read this GAO report, I have to conclude that the FDA view of its responsibility on egg safety issues is almost non-existent. It comes in after the fact, after someone is sick, to try to figure out what happened. The incidence of inspection by the FDA once every 10 years suggests that this is an example that cries out for you to give it up, get out of the egg business. Let's give this to the FSIS and tell them we want it to be based on good public health science and try to put it under one roof. I just don't think the FDA has devoted the resources or attention to this issue that it should, and please respond. Mr. Potter. Thank you for your kind remarks about FDA. Regarding your criticisms, the first thing I would like to respond to is the one person working on eggs. Obviously, we have, as I said in my response, some portion of the work day of a large number of people who deal with eggs. We don't have the inspection force that USDA agencies have, and as the Chairman pointed out, very often we depend on collaborative arrangements with our partners in State agencies to do much of our inspection and field work. We trace back eggs from outbreaks to laying houses for a number of reasons. One, obviously, is a reaction to the outbreak to remove dangerous eggs from the marketplace, but more importantly, perhaps, is on a prospective basis, those investigations, 112 laying houses, 6.7 million hens during the last couple of years, teach us about those critical factors that introduce and maintain Salmonella in those laying houses so that we can come up with the performance standards for critical control points and establish proactive prevention programs. Senator Durbin. I will ask one last question and turn it back over to the Chairman. We have not mentioned pasteurization of eggs, which I had to have people explain to me. I thought if you have to heat an egg, doesn't it cook the egg, and it is my understanding that there is a process that can pasteurize an egg and, therefore, reduce if not eliminate the possibility of SE contamination even for shell eggs. Is that correct, Doctor? Mr. Potter. That is correct. Senator Durbin. And let me ask you this: Has the Food and Drug Administration developed any performance standards for shell egg pasteurization to suggest this is the answer to protect American consumers and give them peace of mind? Mr. Potter. The Food and Drug Administration as early as 1990 recommended the use of pasteurized egg products, the broken-egg pasteurized products, in nursing homes and hospitals and for egg dishes that would be made from pooled eggs. So we are very strong proponents of pasteurizing technologies, and we are in our approach to food safety attempting to make our guidance and regulations technology driving so that we encourage new technologies that will produce things like in- shell pasteurization. One of the comments we got back early in this SE problem from nursing home food service managers was that people in nursing homes really look forward to their sunny-side up egg and we were taking that away from them by requiring them to use pasteurized egg products. And we think that it is a tremendous advance to be able to pasteurize eggs in the shell so that we are not taking that one sunny spot out of the day of people in nursing homes. Senator Durbin. Let me try again. I understand what you have said. I understand that pasteurizing the processed eggs and broken eggs is a good consumer safety move. But your responsibility at the FDA is for shell eggs, too, and now we have the technology to pasteurize shell eggs. The question I asked you was: Have you developed at the FDA a performance standard for shell egg pasteurization? The same question. Mr. Potter. OK. Senator Durbin. Yes or no? Mr. Potter. Let me ask Dr. Troxell to give you a direct answer. Mr. Troxell. Thank you. We have advised AMS on the appropriate performance standard for in-shell pasteurization, a five-log reduction to use in their seal program they are developing. Also, this technology, while it is very promising, is still being pilot-tested, and the feasibility on implementing this technology on a national basis is still a question that we are very interested in pursuing. Senator Durbin. How many years have you been field testing? Mr. Troxell. We have not been field testing this technology. Several companies have been field testing the technology. Some of the systems have been rather crude in form. Others are now developing specific engineered systems to run this kind of in-shell pasteurization. As you pointed out, it is very easy to cook the egg, so one has to be very careful on the appropriate temperature. Senator Durbin. I am going to leave this area---- Senator Voinovich. For the record, would you please give me your name and the title you have? Mr. Troxell. I am Dr. Terry Troxell, the Director of the Office of Plant and Dairy Foods and Beverages at the FDA. Senator Voinovich. Senator Durbin, we better---- Senator Durbin. I am going to conclude. The last thing I will tell you is that in 1994, 5 years ago, the FDA set a standard for pasteurization of shell eggs, having learned that a commercial-scale pasteurization technology had been developed which inexpensively processed eggs without noticeably altering aesthetics or functionality. This is something consumers would like to know about, and they would like to have the protection of pasteurization. I don't know what the FDA is waiting for here. I really think that this is another example where, for some reason, much like the temperature question, things have gone on for years and years and years, and people have become sick, some have died, waiting for the Federal Government to meet its responsibility. Thank you, Mr. Chairman. Senator Voinovich. Thank you. I would like to finish up with one question for all of you. We have seen a reduction in the number of SE cases, so obviously something is being done. For the record, where is most of the problem in terms of this? Is it on the farm? Is it in the processing and shipping? Or is it mostly generated in the institutions that use the eggs? For example, how many of these cases come up when we use eggs in a family? Is most of the problem in institutions? Mr. Potter. About half of outbreaks are related to institution--excuse me, to commercial food service, which would include restaurants, schools, and hospitals. Senator Voinovich. So half the problem is in the place where the eggs end up? Mr. Potter. Well, what the joint risk assessment showed us is that there are critical factors at each step in the chain, and there are opportunities for intervention at every step in the chain. I think that most of our early attempts have been focused on the laying house during egg production and at the kitchen because those are the two areas that we felt we could address first. Senator Voinovich. And you think that those two areas are where you have made the most inroads rather than the people that are at the institutions? Mr. Potter. Well, again, institutional food service, the kitchens there have been a major focus. The agency has collaborated on training videos for nursing home food service directors and medical directors who are getting ready to go out to nursing directors and food service directors with additional advisories for about 12,000 nursing homes, 80,000 day-care centers, 60,000 elementary schools, to get this information in the hands of not only those institutions, but in the hands of parents of young children, too, to hit at both ends of the age spectrum. Senator Voinovich. Thank you. We will now move on to our next panel. Senator Voinovich. I would like to ask the second panel to come forward. It is composed of experts on the issue of egg safety and representatives of the egg industry. Michael Jacobson, a Ph.D., is the Executive Director of the Center for Science in the Public Interest. Ms. Jill Snowdon, Ph.D., is the Director of Food Safety Programs at the Egg Nutrition Center. Keith Mussman, co-owner of Mussman's Back Acres, is from Illinois, and is appearing on behalf of the United Egg Producers. And Harold ``Butch'' DeVries, Executive Vice President and General Manager of Mallquist Butter and Egg Company, is also from Illinois. We would like to thank all of the witnesses for coming this morning. I again want to reiterate that your statements will be entered into the record. We would appreciate your limiting your testimony to no more than 5 minutes, and because we are running out of time, I am going to be pretty fastidious about sticking to that 5-minute rule. Senator Durbin, would you like an opportunity to introduce the witnesses from your State? Senator Durbin. Just very briefly, I am happy to have two witnesses with Illinois connections. Harold DeVries of Rockford, Illinois, married with two children and three grandchildren. His business started in 1930, and he came to work at Mallquist in his senior year in high school in 1955, 44 years ago. The business has nearly half a million chickens, produces and processes 11,000 cases of eggs a week for the Chicagoland area. Keith Mussman, from Back Acres, Inc., a family farm corporation with 1,200 grain farm and 240,000 laying hens. They produce, process, and distribute eggs in Illinois and Indiana. He was born and raised in Grant Park, which is in northeast Kankakee County, and lives there with his wife Barbara and three kids. Thanks for being here. Thank you all. Mr. Jacobson. I have to confess I am also from your great State of Illinois. Senator Durbin. We are everywhere. Senator Voinovich. Now I know why he wanted to have this hearing. [Laughter.] We have heard from the Federal agencies. This is interesting. Now we are going to be hearing from the people that are actually producing the eggs and also the public interests who are interested in protecting the citizens. We really appreciate your being here. We are going to start off with Dr. Jacobson, who is the Executive Director of the Center for Science in the Public Interest. Dr. Jacobson, we would like to hear from you. TESTIMONY OF MICHAEL F. JACOBSON, PH.D.,\1\ EXECUTIVE DIRECTOR, CENTER FOR SCIENCE IN THE PUBLIC INTEREST Mr. Jacobson. Thank you very much, Senator. --------------------------------------------------------------------------- \1\ The prepared statement of Mr. Jacobson with an attachment entitled ``Scrambled Eggs,'' appears in the Appendix on page 80. --------------------------------------------------------------------------- CSPI is a non-profit consumer-advocacy organization that focuses on nutrition, food safety, and alcohol issues, and is supported by our 1 million members, including thousands in both Illinois and Ohio. Accompanying me today is Caroline Smith DeWaal, our Director of Food Safety, sitting behind me. Most consumers think that government watchdogs are ensuring that their food is safe. But any watchdogs that there were, were asleep while eggs contaminated with Salmonella grew into a national public health epidemic. Twenty or so years ago, a strain of Salmonella called enteritidis developed the ability to infect a chicken's ovaries and enter an egg before it is laid. The advent of that enterprising strain of bacterium means that it is no longer safe to eat runny eggs, taste cookie dough, or enjoy raw eggs in desserts and salads. Today, infected chickens lay an estimated 2.3 million contaminated eggs each year, any one of which could cause an illness or an outbreak of food poisoning. Since 1990, eggs have been directly linked to at least 123 separate outbreaks of food poisoning, mostly from SE. CDC has reported that since 1985 there have been nearly 800 SE outbreaks largely associated with eggs and egg dishes. A recent risk assessment on eggs conducted by USDA said that SE-contaminated eggs have caused an average of 660,000 illnesses and 330 deaths annually. While the CDC data from a few areas around the country suggest that the number of illnesses has declined, many more illnesses could be prevented with mandatory national programs. Some people say that the consumer should be the only critical control point. We say that consumers should be able to expect that eggs are safe. In 1986, CDC first identified SE in eggs as a public health problem when there was a food poisoning outbreak that sickened more than 3,000 people. Since then, unfortunately, no government agency has mounted an intelligent, comprehensive counter-attack on SE. There is no government-mandated SE testing program for eggs or laying flocks, no mandatory expiration date for shell eggs, no ban on repacking and re- dating old eggs, no mandatory refrigeration of eggs throughout the distribution chain, and no label on egg cartons to alert consumers. The government has simply failed to take the necessary steps. Instead, the production of safe eggs has been stymied by overlapping responsibilities between FDA and USDA, irrational assignment of inspectors, and two agencies developing duplicative and competing SE control programs. Eggs provide one of the best illustrations of the need for a centralized Federal framework for food safety as proposed by Senator Durbin last week in the Safe Food Act. In 1997, in an effort to jump-start government efforts, CSPI petitioned the FDA to develop a mandatory on-farm control program for eggs modeled after an effective State program. CSPI also petitioned FDA to require a label on egg cartons alerting consumers to the risks and advising them to cook eggs thoroughly. There has been little visible action since CSPI petitioned the FDA, but we hope that this Federal Register announcement--that we haven't seen yet--will pave the way for action in the foreseeable future. The actions that the agency has mentioned today are important but not sufficient. In a critical omission, FDA and USDA have failed to utilize the single most effective public health measure, and that is on-farm SE monitoring and control. Though temperature controls and labeling help prevent illnesses from contaminated eggs, on-farm programs like HACCP would help prevent eggs from being contaminated in the first place. Under an on-farm program, manure and eggs would be tested for SE, and eggs from flocks that test positive would be diverted to pasteurization plants where they would be rendered harmless. Programs like that appear to be working in some States. We need such programs mandated as soon as possible throughout the country. Thank you very much for your attention to this important public health problem. Senator Voinovich. Thank you very much, Dr. Jacobson. We will now call on Jill Snowdon, Director of Food Safety Programs, Egg Nutrition Center. TESTIMONY OF JILL A. SNOWDON, PH.D.,\1\ DIRECTOR OF FOOD SAFETY PROGRAMS, EGG NUTRITION CENTER Ms. Snowdon. Thank you very much. I serve as the Director of Food Safety Programs at the Egg Nutrition Center, which is a scientific and technical resource on nutrition and food safety of eggs and is a joint effort between the American Egg Board and the United Egg Producers. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Snowdon with attachments appears in the Appendix on page 122. --------------------------------------------------------------------------- The pursuit of egg safety should be considered a success story. The disease incidence of salmonellosis caused by Salmonella enteritidis, which we know as SE, has been on the decline in the United States. Multiple lines of evidence--taken from data collected over the last 3 to 8 years, from both national and regional levels, including both sporadic cases and outbreaks--show the same downward trend. SE outbreaks from both egg and non-egg sources have decreased from a high of 82 outbreaks in 1990 to 45 in 1998. Both the number of outbreaks and the number of people ill in the outbreak have decreased. The incidence of this disease is also recorded in CDC's Salmonella surveillance system and records a decline in salmonellosis caused by SE on a regional basis. This is also reflected in data from States such as California and Pennsylvania. They, on their recording basis, are also showing a decline. But perhaps the most compelling line of evidence for the decline is from CDC's FoodNet program which reports a 44 percent decline in salmonellosis caused by SE over the last 3 years. FoodNet data indicate 1.4 million cases of salmonellosis in the United States in 1997. Fifteen percent of the reported cases were caused by SE. One could estimate on these numbers than that there were 210,000 cases of salmonellosis caused by SE in the United States in 1997. These cases can result from a number of food and non-food sources, including eggs. There are a few other indicators of this decline, and they are included in my written testimony. It should be pointed out that illness from SE is only a fraction of all cases of salmonellosis and that eggs account for only a portion of all of those reported cases. There are a number of characteristics which make eggs unique, and the unique qualities of eggs should be--the biological and physical unique qualities of eggs need to be taken into consideration if we are developing effective intervention strategies. SE is associated with the infection of an internal organ. This is in contrast to all other foodborne microorganisms which are typically associated with feces and dust. This may dictate the type of control mechanisms that then become most effective. The egg, intended to be new life, has multiple properties that deter or destroy microorganisms. These properties are listed in the written testimony. I am going to concentrate on just one--that of the yolk membrane. If the yolk membrane is intact, SE will not grow because of an absence of nutrients. So the integrity of the yolk membrane is determined by time and temperature. Data from the United Kingdom indicate that SE will not grow in eggs for about 28 days if they have been stored at 60 degrees Fahrenheit or less. However, the security of the intact egg vanishes once that egg is broken and its contents are mixed together. Once the natural antimicrobial properties are destroyed, the liquid egg has to be pasteurized, cooked thoroughly, or held chilled to ensure that microorganisms do not grow. Proper care of pooled eggs may be the most critical control point in the spectrum of egg safety. Senator Durbin, if I can make a small but important addition to your observation about the outbreak in Virginia, when I spoke with the investigator in charge of that outbreak investigation, he indicated that they closed the restaurant down as soon as they walked in because the food preparation practices were so abysmal. In that conversation with him, he indicated that they were using bare hands to handle sausage and bacon, and then those same bare hands were dipping toast into the egg batter mix. So the production of safe food needs to be accompanied by the safe preparation of food. The industry supports food service education. As an example, I would like to include this book, which is the American Egg Board's food service recommendations for eggs, as part of the record, please.\1\ --------------------------------------------------------------------------- \1\ ``The Incredible Edible Egg, A Natural For Any Foodservice Operation,'' appears in the Appendix on page 151. --------------------------------------------------------------------------- To move food safety from production to preparation is part of the goal of protecting the food supply. The egg industry became aware of this problem, identified ways to combat it, and implemented actions. Now disease rates are dropping, and the egg industry is continuing to look for additional techniques to combat SE. I have appended a list of industry activities to the testimony and will only mention participation and quality assurance programs in my verbal testimony. Participation in industry-generated quality assurance programs continues to increase. All quality assurance programs in the egg industry have been based on the principles of Hazard Analysis Critical Control Points, which is the best technique to protect the food supply. In a survey of large producers in the United States, 93 percent were producing eggs under the guidelines of a quality assurance program. In a survey of the top six egg-producing States, it was estimated that between 85 to 95 percent of the eggs in those States were produced under a quality assurance program. Microbiological analysis of manure samples from laying houses detects Salmonella enteritidis about 3 percent of the time or less, further evidence that the presence of SE in laying houses is the exception, not the norm. In addition to diverting eggs as part of quality assurance programs, the organism is controlled by a variety of means and mechanisms dictated by a HACCP program. In summary, I would say that the pursuit of egg safety should be considered a success story. The public health community discovered the problem and placed much of the responsibility upon egg producers. After years of effort-- including extensive scientific research, debate, controversy, education, and changes in production and food preparation practices--the trend in disease incidence is downward. The egg industry has contributed substantively to this success. The recent decline in both outbreaks and sporadic cases has occurred in geographic areas where control measures have been most intense. But even though the fruit of man labors are beginning to ripen, there is still more work that needs to be done. The egg industry remains committed to continuing to take the steps that continue to make the rates drop. Thank you for inviting us to be part of this hearing and to be part of the process to ensure a safe food supply. Eggs are a nourishing, appealing, economical food that can continue to be enjoyed with assurance. Senator Voinovich. Thank you, Dr. Snowdon. Our next witness is Keith Mussman, co-owner, Mussman's Back Acres, representing the United Egg Producers. TESTIMONY OF KEITH MUSSMAN,\1\ CO-OWNER, MUSSMAN'S BACK ACRES, ON BEHALF OF THE UNITED EGG PRODUCERS Mr. Mussman. Mr. Chairman, and Senator Durbin, thank you for this opportunity to be here today. I believe it is an opportunity of a lifetime. And if I may add an aside, Senator Durbin, as a resident of Illinois, I am proud to be one of your constituents. --------------------------------------------------------------------------- \1\ The prepared statement of Mr. Mussman appears in the Appendix on page 169. --------------------------------------------------------------------------- Senator Durbin. Thank you. Mr. Mussman. Good morning. My name is Keith Mussman, and I am a farmer producing eggs in Illinois. I have been in this business all of my life, having followed in the footsteps of my father who produced eggs and sold them in the Chicago area almost 50 years ago. I am testifying today on behalf of my industry organization, United Egg Producers, a national cooperative representing the interests of nearly 80 percent of all egg production nationwide. The egg industry considers food safety of paramount importance and is committed to enhancing the safety of shell eggs and egg products as is evidenced by the number of voluntary programs it has undertaken. For example, the egg industry through UEP has developed a national five-star quality assurance program. UEP has sponsored HACCP training workshops, published egg handling and preparation guidelines for food service employees and consumers, and supported FDA in determining that eggs, like other protein-rich foods, should be classified ``potentially hazardous.'' Data were collected in a recent survey from 41 egg producers with 1 million or more laying hens and representing a total 125 million layers, which is approximately 50 percent of the Nation's total. Of those responding, 93 percent reported to be participating in one of the industry's egg quality assurance programs. The egg industry has initiated and implemented voluntary programs in response to every concern raised about food safety, while providing a wholesome food at a price comparable to or now even less than it was at the time my father was marketing eggs in Chicago 50 years ago. In 1998, FoodNet reported a 44 percent decline in Salmonellosis attributed to SE during the past 3 years. Likewise, the record on outbreaks--where two or more people became ill--shows a decline in illness that began in 1990. The Egg Products Inspection Act of 1970 provides uniform standards of quality, grade, condition, weight, and labeling for shell eggs in interstate commerce. Eggs which fail to meet grading standards are either diverted to the breaking market for pasteurization or deemed inedible for humans and processed for other uses such as pet foods. Shell eggs are cleaned in wash water of approximately 110 degrees Fahrenheit, or 20 degrees higher than the egg temperature. A sanitizing solution is used in the washing process to enhance cleaning. Soon after processing, eggs are packaged and stored at 45 degrees Fahrenheit. Most of the SE outbreaks associated with food have been a result of improper food handling and preparation. Holding raw egg batters at room temperature for extended times, using containers that go unwashed between uses, inadequate cooking, and inadequate cooling of leftovers have all contributed to foodborne outbreaks. It is a fact that a zero-risk or a sterile food supply is impossible. It is important that accurate information is communicated about risk and that sound food service educational information is provided to consumers, and particularly to the food service sector, so that everyone is well educated in safe food handling and understands their responsibilities for ensuring food safety. Just as there is no single control method that will eliminate all pathogens and toxins from the food chain, there is no single method for providing a 100 percent guarantee that foods will be free of pathogens. For the most part, the different agencies the producers and processors must deal with are doing a difficult job well. We as producers do not always agree with the actions taken by these agencies, of course, and when we disagree with them, we have not been shy about saying so. We have not had the GAO report long enough to study it in great detail. However, we are not convinced that the structure of our food safety agencies is the problem. They have different roles and different areas of expertise. To us, the real issue is what our public policy should be, not who implements them. Under the present system, we have already witnessed a significant decline in the number of cases of Salmonellosis since 1996. Coordination among agencies currently provides checks and balances. Congress, of course, should insist that this coordination be cooperative rather than competitive. Everyone's goal must be protecting food, not turf. I want to finish up with a few brief comments about the GAO report. I just got it yesterday, so I haven't had time to study it thoroughly. But I have looked at the recommendations GAO makes to the agencies. First, GAO recommends that FDA develop a model HACCP-based program for egg operations that could be adopted by the States. Our industry is implementing HACCP-type programs and is receptive to this recommendation. However, we would want to review any FDA proposals. Second, GAO recommends HACCP for egg-breaking plants. Generally, our processor members are supportive of HACCP regulation, and many have HACCP plans in place already. FSIS has said it intends to propose exactly this kind of system. Third, GAO recommends study of the costs and benefits of implementing rapid cooling techniques in egg processing and packing operations. We agree that research is a good idea, and, in fact, quite a bit has been done. However, commercial applications are still a ways off. The increased cost would be a concern, and as I understand it, the consumer would not benefit from a health standpoint. I do wish GAO had given the agencies a little more credit for working together in recent years, and I wish the positive steps our industry has taken had been highlighted more. We have not been followers. We have been leaders. I am proud of my business and of my industry for promoting a safe food supply. Thank you. Senator Voinovich. Thank you, Mr. Mussman. Our next witness is Harold ``Butch'' DeVries, Executive Vice President and General Manager of Mallquist Butter and Egg Company. Mr. DeVries. TESTIMONY OF HAROLD ``BUTCH'' DEVRIES, JR.,\1\ VICE PRESIDENT AND GENERAL MANAGER, MALLQUIST BUTTER AND EGG COMPANY Mr. DeVries. Thank you, Mr. Chairman, Senator Durbin. Good morning. My name is Harold DeVries, and I am Vice President and principal stockholder at Mallquist Butter and Egg Company in Rockford. My company is a small agricultural business packaging about 4 million eggs per week from its one-half million laying chickens. We also distribute liquid and frozen eggs. I am here today at the request of Senator Durbin's office. --------------------------------------------------------------------------- \1\ The prepared statement of Mr. DeVries appears in the Appendix on page 180. --------------------------------------------------------------------------- Food safety is very important to me personally, to my company, and to my industry. The reputation of my company is dependent upon quality, and we operate quality assurance programs to ensure a safe food supply. Mallquist Butter and Egg Company has instituted procedures to identify those critical control points from the farm through distribution for monitoring quality assurance, including cleaning and disinfecting the poultry house, rodent and pest control, proper egg washing, biosecurity, and refrigeration. Today I want to share some information about food safety action in the State of Illinois, discuss a task force that was established by the Department of Agriculture and Public Health to analyze food safety issues, and to recommend actions to resolve public concerns. As a producer, I had the honor of serving on that task force. During 1998, local health departments in Illinois investigated almost 1,200 complaints about food and illness. Microorganisms that caused the foodborne outbreaks could only be determined in one-third of the incidents; two-thirds of the outbreaks occurred because of unknown causes. While the causes and effects of foodborne diseases are better understood today, emerging risks need to be monitored. For example, consumers are changing; increasing numbers of elderly and others are at higher risk of severe illness; consumers spend less time cooking than ever before and may have received less instruction on food handling at home or school. Where the rubber meets the road is at the local level. More than 90 Illinois local health departments and 135 municipalities provide food safety functions at the community level through inspections of restaurants, schools, caterers, and food stores for adherence to food safety requirements. They promote safe food-handling behaviors through educational efforts with school children, the general public, and the retail food industry. The HACCP system is widely accepted by the scientific community as the best known approach to enhancing the safety of foods. If HACCP systems are fully implemented, the effectiveness of the food safety system can be enhanced significantly, but absolute safety of potentially hazardous foods cannot be assured. The first recommendation from the task force is to broaden coordination and cooperation between the Illinois agencies with the respective Federal and local counterparts so that food safety programs are consistent and uniform. The second recommendation is for the development of a mechanism to ensure that regulated industries, government agencies, and the general public have a formal venue to advise the Departments of Agriculture and Public Health on issues of mutual concern relative to the food supply. The task force also recognizes the value of the Federal Government's FoodNet. In the last 3 years, as reported by FoodNet, the incidence of Salmonellosis associated with SE has decreased 44 percent. This is great news for the egg industry and the public. It suggests that efforts by the industry are having an effect. The egg industry has demonstrated responsiveness and cooperation with Federal, State, and local agencies in addressing the safety of shell eggs and egg products. A large number of agencies are involved in food safety. However, the expertise from these agencies addresses the issue of food safety from different and complementary perspectives. The egg industry has developed numerous programs and activities designed to enhance food safety and to educate the channel from farm to table in the proper production, transportation, processing, handling, and preparation of its products. Education and training can be one of the least costly yet most effective means to protect consumers from foodborne illness. Increasing individual awareness of food safety matters all through the food chain and motivating customers to adopt simple, yet important sanitation and food-handling behaviors is effective in improving food safety. Thank you. Senator Voinovich. Thank you, Mr. DeVries. I am pleased to hear that the industry is doing what it can to improve food safety, and I think it is logical that you would do that. You are in the business and you want people to buy your product, and if everyone thinks it is not safe, they are not going to buy eggs. So I am sure that you are trying to do your very best in your own operation to make sure it is as clean as possible because if it is not, it affects your business. I also would like to compliment the State of Illinois for looking at the local contribution to improve the situation. We were talking earlier when you were gone, Senator Durbin, that the States do have a role, the Federal people said that there is a definite role for States, and that they couldn't handle it without State involvement. I think that more activity in the area of best practices should be shared throughout the country to guarantee that things are going well on the farm and also that better food safety and preparation is being practiced. From your perspective, is the real problem in the food handling and preparation rather than on the farm? And we have talked about a reduction of some 40 percent. Where did the reduction take place, as a result of what? Does anyone want to comment on that? Mr. Mussman. I will jump in on that one. I think the reduction has come because of a better awareness both on the farm and in food handling on how to better handle eggs to make them safer. One statistic that has leapt out at me continually is science has pretty much stated that perhaps one out of 20,000 eggs is contaminated with SE. If you extrapolate that for the number of eggs a person eats, 240 or 250 eggs a year, your chances of being exposed to a Salmonella-infected egg would be once in 84 years. Now, I realize if your wife is the one that got it, that is very important to you. But just keeping those statistics in mind, the risk is really minute. In answer to your original question, because those numbers are so minute, it is believed that most of the problems are at the food-handling end of the situation, as Dr. Snowdon mentioned on that other outbreak. Just plain mishandling of food. Ms. Snowdon. The industry recognizes it has a responsibility to produce the best and safest product it can, and it has been taking the kinds of steps to do that. So I think that certainly is one of the reasons that we have seen the decline, the concerted effort at the production level to ensure that the organism doesn't move into the hens to begin with, if it moves into the hen that it doesn't make it into the egg, if it makes it into the egg that it doesn't make it into the marketplace. So that is definitely a part of it, and industry is aware of that responsibility and fulfills that responsibility. I think the contrast that Mr. Mussman just pointed out is one that has also struck me from the viewpoint, and my point that once that shell is broken, that you have a phenomenal opportunity for growth and spread both. And so that no matter how clean the product an industry produces, it has got to be accompanied by appropriate food-handling practices. I think that we are seeing an increase in that, the FightBac campaign that we have at the national level, other national level educational programs the industry has put together in terms of appropriate food-handling practices. So I think that we are starting to work the entire spectrum, and I think that the benefits that now we are getting in the last couple of years are a result of working that entire spectrum. Senator Voinovich. Dr. Jacobson. Mr. Jacobson. I think the egg industry does deserve praise for the actions that it has been taking. It is great to hear of these individual reports from particular operations. But it has been a long time coming. And as Senator Durbin emphasized, government regulation has been a long time coming. Taking 8 years to get out a rule on temperature is too long. Despite the regulations, the voluntary industry practices, I don't see handling labels on eggs warning somebody of a problem, saying cook it thoroughly. I haven't heard the egg industry voluntarily banning the practice of repacking. And I don't think the egg industry can do it because it is a diverse industry, not every company is part of the United Egg Producers. It is simply voluntary. The GAO report says the States have a patchwork of programs, presumably some better than others. But if the industry is doing as good a job as it is presenting, I don't see why it wouldn't mind having a mandatory Federal floor, a mandatory HACCP program dictated with parameters set by the FDA and USDA, so that would be the floor, and if some companies want to do better, fine. But at least have that mandatory floor so we are not waiting for voluntary industry action. And as we see in so many areas, voluntary action can be temporary action. It can be crisis-driven. We see it today, but if the pressure is off, things can go back to the old ways. That is why we would like to see some mandatory rules for mandatory Federal rules so that flocks are inspected for SE, and if a contaminated flock is discovered, eggs would be diverted to that pasteurization stream--not thrown out. I don't see why the egg industry would object to having a sensible program. This current system, as described by the GAO, is crazy. It goes from, at the upper left of the chart, USDA to FDA, then down to USDA, then back to FDA, then to either one of them, depending where it is. That is a crazy system. It needs to be rationalized. And it is especially dramatic when you have those 102 USDA inspectors inspecting pasteurized eggs that are the safest ones you can get. And FDA every 10 years inspecting fresh shell eggs. That doesn't make sense. And, of course, that is driven partly by the budgetary process where FDA money is FDA's, and USDA money is USDA's, and they can't mix. If you had a single food safety agency, as Senator Durbin and several other Senators and the GAO have recommended, I think we could have a more sensible and possibly even a more economical approach, and certainly we could get a timelier response to food safety problems. Senator Voinovich. Thank you. I pointed out earlier that each of the Federal agencies, under the Results Act, are supposed to be putting together performance standards and goals for their respective agencies. One of them requires coordination, and I would be interested to find out from the Department of Agriculture and from Health and Human Services just how much they have sat down with each other to talk about how they coordinate their activities and to identify holes that are there and how to respond to them, as you just pointed out in your testimony. Mr. Jacobson. I think for the country, though, it doesn't make sense to be stuck with a jerry-rigged system, not just for eggs but food safety in general, where the Commerce Department does fish, and the Treasury Department cares about alcoholic- beverage safety. It doesn't know anything about health. It doesn't make sense, and there shouldn't have to be this complicated web of probably temporary jerry-rigged collaborative efforts when you could have one sensible and really seamless system for helping ensure the public safety. Senator Voinovich. Would anyone like to comment on that? Mr. DeVries. I would just like to make a comment and clear up a few things that you talked about earlier about the age of eggs before they were packaged and dating and those types of things. We are an off-line operation, so the eggs don't go into the egg washer and grader immediately, but within 2 days they are always packaged. And from that point on, there is a 30-day expiration date put on the eggs. In the State of Illinois, we have been doing that now for, I think, over 25 years. You talked about refrigeration. We have been refrigerating eggs in Illinois since I became employed there at 60 degrees, and when this was brought up in 1991 about the 45-degree temperature, we then instituted that also, and we have been carrying that out. So, from our standpoint, the State of Illinois has a great egg inspection program that followed through with the Department of Agriculture and the Health Department. Senator Voinovich. Mr. Mussman. Mr. Mussman. I concur. Senator Voinovich. Do any of you think that we need to have improved regulation on the Federal level in terms of your industry? You start smiling at that question. But have you, as an organization, made recommendations to any of the Federal agencies involved on how they could improve their operations? Mr. Mussman. I think one of our concerns has been the cooperation between the agencies, but we sincerely feel that that is a management problem. It is not a problem having it in the different organizations. It is just there are organizations themselves sorting out who is going to be in control. United Egg Producers has taken a position for 21-day expiration dates. Even though there is no law prohibiting repacking of eggs, UEP's position for years has been to not do it. Obviously, there are some renegades out there that will. I think not just the egg industry, but other industries are the same way. You have got some guys that don't play by the rules. We feel sincerely that we have been leaders in the food safety issue, and we have had tremendous cooperation with FDA, USDA, and FSIS on the issue. Speaking from--I am going to take off my egg producer hat and put on my taxpayer hat right now. I told my father I was coming out here and explained the reason, and he said, ``They are just going to add another layer of bureaucracy.'' From the grass-roots issue, that is a tremendous concern. Government never gets smaller. You can take all these things away from the other departments and create--I don't care what you call it. It is going to add costs to the government, and we sincerely believe that it is not going to make food safer. Senator Voinovich. Well, I appreciate your comments. I know that has been one of the things that you hear from folks about a new agency, that it becomes kind of a large burgeoning agency that makes it more difficult for people to get answers. But you don't have any complaints that you have FDA, then you have USDA, and then you have the State agencies all visiting your places? No complaints from your people about the multiplicity of agencies that are regulating your operations? This makes sense? Mr. DeVries. From my standpoint, we are inspected on a quarterly basis by USDA. Of course, our State of Illinois Department of Agriculture is in there quite often. They are always in there on an unannounced basis all the time. The local health department shows up also. We have no problems with any of those things. We work with them. We are happy to work with all of them. One of the other issues that was brought up is we do have on our egg cartons ``keep refrigerated.'' We do have safe cooking and handling labels inside the egg cartons also. And we do no repacking of eggs, never have done, never will do. There is no reason for that. Those eggs just belong to the breakers for further processing. So from our standpoint, we really have no problems. Senator Voinovich. Thank you very much. I am out of time, and I will turn it over to Senator Durbin. Senator Durbin. Thank you very much, Mr. Chairman. Mr. DeVries, let me follow up on that because I think you are giving us valuable testimony about the real world out there. You said that you just don't repackage eggs. That has been a standard at your business for a long time, has it been? Mr. DeVries. That is correct. Senator Durbin. And, Mr. Mussman, is it the same standard at yours? Mr. Mussman. Same standard. Everything goes either in restricted eggs and if it is broken, it goes in a barrel. If it is cracked, it goes to restricted for further processing. Senator Durbin. How did you happen to adopt that standard? Is that something that just made common sense to you, or did you have a bad experience? Mr. Mussman. In our particular instance--I heard him talking before--we are not a USDA-inspected plant. We fall in that 70 percent. We were a small business, but it has grown over the years. We were never required to so we haven't. But there is one thing that goes on our label that takes precedence over any USDA label, and that is Mussman's Back Acres. So it was common sense. We can't afford to put a product out there that may come back and bite us. I know there are a lot of other egg producers in the same boat. It is not worth the risk. Senator Durbin. But let me just ask you this question: If we had a problem in Illinois with eggs, wouldn't it really be to your benefit if everyone is held to kind of a basic standard so that the bad actors don't get off the hook? You are two responsible egg producers and packagers. What I am driving at is this: You take pride in your label. Both of you do. But if we had an egg problem, people would perhaps stop buying your product for a while, too, uncertain as to whether or not you were the good guys or the bad guys. When we establish a standard where consumers have some confidence, doesn't that help all egg producers? Mr. DeVries. I would say yes to that effect. Absolutely it would help all egg producers. Just like when we had the scare with the cholesterol things years ago, we saw our business go down. Now we got rid of that, and our business--the number of eggs eaten by consumers has gone up each year. We have seen things come down even though we are eating more eggs. It would be great to have everybody play by the same rules. Senator Durbin. Well, Mr. Mussman, let me ask you a question. Mr. DeVries talked about the fact that it is about 2 days between the laying of eggs and the packaging. Is that your experience as well? Mr. Mussman. Our operation happens to be in-line. We process 7 days a week, and the eggs come directly from the birds and they go right into the carton. Senator Durbin. So that is hours? Mr. Mussman. They are 5 hours old when they get to the cartons. Senator Durbin. And that, again, is a standard which you have put into your business place, is it not? It is not mandated by anyone, is it? Mr. Mussman. That decision was based somewhat on economics rather than just for a pure freshness situation. It just worked out for us to do it that way. Senator Durbin. But there is no regulation or law along that line? Mr. Mussman. No. Senator Durbin. Now, our State of Illinois is one of the 17 States, incidentally, in the Nation which requires a labeling on the egg cartons of an expiration date or a sell-by date, and we have sell by 30 days. But you mentioned 21 days as being a standard. Is that the UEP? Mr. Mussman. That number has been bandied around, and UEP has gone on record with a position that they would support 21 days if that was to come into effect. Senator Durbin. And that basically--does it start from the belief that the older the egg, the less likely it is going to taste good and it might even be less safe as it gets older? Mr. Mussman. That, and it doesn't appear as well on the plate. There are a number of reasons. But safety is certainly one of them. Senator Durbin. So it goes back to my earlier point. If I am traveling around the country and I am buying eggs in a restaurant here, there, or any other place, if there is a standard, a reasonable standard which your industry says helps us all, all egg producers--it strikes me that that helps you because you are playing by good rules, rules that you have assumed for your own business to make sure that when you put your name on a carton you feel proud. Is that not correct? Mr. Mussman. That is totally correct, and we would dream that everyone would play by the same rules. But what it still ultimately comes down to is, if I produce an egg that is 5 hours old when I put it in the carton and I deliver it tomorrow to the local restaurant, and they break it in a bucket and leave it sit out at room temperature for 13 hours, then it becomes a food-handling problem. Senator Durbin. And that is a good point, and I want to go back to Dr. Snowdon's point about the restaurant in Richmond, Virginia. I have not identified the chain, but I am going to now. It is IHOP. And let me tell you what the Vice President for Operations for the Eastern United States, John Jordan, said in the Richmond newspaper of June 12, 1999. He said he was aware that the egg wash the restaurant used to prepare French toast had received a positive reading for Salmonella bacteria. He went on to say--in an effort to prevent further problems, Jordan said the restaurant will now be using processed and pasteurized eggs for its French toast batter rather than eggs in the shell. For the record, I do not disagree with the premise that safe food handling is an important element in this. But in this situation, for whatever reason, there was a contaminated egg mixture which Mr. Jordan has acknowledged was part of the problem and said that they were going to steps to deal with it. Can we stay for a moment on this question of pasteurization, which was this restaurant's chain response? Do you pasteurize shell eggs in your operation, Mr. DeVries? Mr. DeVries. No, we don't. Senator Durbin. Mr. Mussman, do you? Mr. Mussman. No. Senator Durbin. How common is that in your experience in the State of Illinois? How many egg producers actually pasteurize shell eggs? Mr. DeVries. I believe it may only be one or two people in the whole country, and it has just been---- Senator Durbin. Just starting out? Mr. Mussman. It is the new technology. Senator Durbin. New technology. Mr. DeVries. The thing about using the pasteurized eggs at the restaurants, too, that is not going to stop an illness if those aren't handled properly. Senator Durbin. Proper handling is part of the deal. Mr. DeVries. The whole thing. Senator Durbin. Absolutely. Now, how about the management? How about the testing of your breeding flock? Are they tested for Salmonella? Has that happened, Mr. Mussman? Mr. Mussman. We buy 18-week-old pullets, so we have nothing to do with the breeding business. But we are assured that our breeding flocks are tested from the chickens that we get. Senator Durbin. OK. The same thing from Mr. DeVries? Mr. DeVries. We grow our own birds, so we buy our birds a day old. And we have an SE testing program all the way through. Senator Durbin. You are the good guys here. I am really glad you are here, and I am glad you are from Illinois. That makes my job a little easier, Mr. Chairman, in regard to that. I want to say to you, Mr. Mussman, if I thought that what we are about here, what I am about here is adding another layer of bureaucracy, I couldn't look you in the eye. What I am trying to do is to eliminate a few layers of bureaucracy. As you heard, this ball is being handed off from agency to agency, and we really think if it is put under one roof that really the buck is going to stop at some agency that really coordinates the efforts here and makes the product a little safer and the cost a little cheaper for taxpayers. And if it doesn't achieve that, it is going nowhere in Washington, D.C., and I certainly am not going to push for it. So you can tell your father and friends that that is something we are going to try to work on. Let me, if I can for a minute, talk about FoodNet, and, Dr. Jacobson, as I understand FoodNet, it is a Center for Disease Control survey of seven States, if I am not mistaken, where they went and took samples to reach this conclusion about a 44 percent decline in SE. Mr. Jacobson. Let me let Caroline Smith DeWaal take over here. Senator Durbin. OK. Ms. DeWaal. The FoodNet data that concluded that there was a 40 percent reduction was taken from just a few areas of the country. It was about eight sites, if I believe correctly, including a number of States. It represents about 7 percent of the U.S. population. And if I just might add, the---- Senator Durbin [presiding]. For the record, please state your name. Ms. DeWaal. It is Caroline Smith DeWaal, Director of Food Safety for the Center for Science in the Public Interest. The actual report that CDC issued where they mentioned the decrease in Salmonella, they say that the reasons for the decline are unclear. They do say that the implementation of these egg quality assurance programs with--and this is critical-- microbial testing and egg diversion in some States may have contributed to the decline. And then they also mentioned that some of the improvements that are happening in the meat and poultry industry also may have contributed to it because right now there is an intensive effort in the poultry industry to reduce Salmonella levels to meet the new HACCP standards for poultry plants. Senator Durbin. I have it that the CDC project, FoodNet, tested in Connecticut, Minnesota, Oregon, selected counties in California, Georgia, Maryland, and New York. Interestingly enough, although there was a 44 percent decline in these sampled States and sampled localities, they found some wide variation. For example, the rate of evidence of Salmonella infection was more than 7 times higher in Maryland than it was in Georgia and New York, and they can't explain the differences there. But that appears to be part of the uncertainty about what we draw from this conclusion. It is certainly a lot better than a 44 percent increase. We have got to acknowledge that. So something is moving in the right direction, and I hope this hearing and some of the things that we have talked about today can bring us further along that course. Let me conclude--the Chairman had to leave the hearing--by thanking Mr. DeVries and Mr. Mussman for coming here, and as I said, for whatever reason, your selection was the right one by the United Egg Producers because, as we listened to the standards which you have voluntarily imposed on yourself because of your pride in the product that you are selling, I am sure it gives consumers a good feeling that there are some good players out there, and probably the majority of egg producers are good players. I just want to get back to my original point here, and that is that we are embarking on a new era where food safety is an extraordinary issue for a lot of people. I literally had breakfast--I can't tell you the man's name or his company, but one of the major producers of food in this country. I had breakfast with him last year, and I said I think food safety is a big issue of the future. And he kind of chuckled, and he said, ``Senator, if that is all you have to worry about, why are you worrying at all? We have got the safest food supply in the world.'' Well, I can't quarrel with that, but I will tell you within a month or two that man was hit with a food safety crisis in his company that cost him literally hundreds of millions of dollars. I think he takes a new attitude toward food safety. There is a vulnerability out there where, unfortunately, the bad actors are going to give some good actors a bad name if we are not careful. And for the consumer's sake and for the sake of egg producers who are doing the right job and using the right standards, I hope we have some sort of a code of conduct, an enforceable code of conduct, that we say this will stand by it. If it has UEP on the label, or whatever it is, you know that you are going to get a product that is a quality product whether you shop in Illinois or California, Florida or New York. That is what I think we should be moving toward. I thank you all for your contribution today. It has been a great hearing, and you have helped to make it so. The record will remain open for 5 days after the conclusion of the hearing. Thank you very much. [Whereupon, at 12:27 p.m., the Subcommittee was adjourned.] A P P E N D I X ---------- [GRAPHIC] [TIFF OMITTED] T9578.001 [GRAPHIC] [TIFF OMITTED] T9578.002 [GRAPHIC] [TIFF OMITTED] T9578.003 [GRAPHIC] [TIFF OMITTED] T9578.004 [GRAPHIC] [TIFF OMITTED] T9578.005 [GRAPHIC] [TIFF OMITTED] T9578.006 [GRAPHIC] [TIFF OMITTED] T9578.007 [GRAPHIC] [TIFF OMITTED] T9578.008 [GRAPHIC] [TIFF OMITTED] T9578.009 [GRAPHIC] [TIFF OMITTED] T9578.010 [GRAPHIC] [TIFF OMITTED] T9578.011 [GRAPHIC] [TIFF OMITTED] T9578.012 [GRAPHIC] [TIFF OMITTED] T9578.013 [GRAPHIC] [TIFF OMITTED] T9578.014 [GRAPHIC] [TIFF OMITTED] T9578.015 [GRAPHIC] [TIFF OMITTED] T9578.016 [GRAPHIC] [TIFF OMITTED] T9578.017 [GRAPHIC] [TIFF OMITTED] T9578.018 [GRAPHIC] [TIFF OMITTED] T9578.019 [GRAPHIC] [TIFF OMITTED] T9578.020 [GRAPHIC] [TIFF OMITTED] T9578.021 [GRAPHIC] [TIFF OMITTED] T9578.022 [GRAPHIC] [TIFF OMITTED] T9578.023 [GRAPHIC] [TIFF OMITTED] T9578.024 [GRAPHIC] [TIFF OMITTED] T9578.025 [GRAPHIC] [TIFF OMITTED] T9578.026 [GRAPHIC] [TIFF OMITTED] T9578.027 [GRAPHIC] [TIFF OMITTED] T9578.028 [GRAPHIC] [TIFF OMITTED] T9578.029 [GRAPHIC] [TIFF OMITTED] T9578.030 [GRAPHIC] [TIFF OMITTED] T9578.031 [GRAPHIC] [TIFF OMITTED] T9578.032 [GRAPHIC] [TIFF OMITTED] T9578.033 [GRAPHIC] [TIFF OMITTED] T9578.034 [GRAPHIC] [TIFF OMITTED] T9578.035 [GRAPHIC] [TIFF OMITTED] T9578.036 [GRAPHIC] [TIFF OMITTED] T9578.037 [GRAPHIC] [TIFF OMITTED] T9578.038 [GRAPHIC] [TIFF OMITTED] T9578.039 [GRAPHIC] [TIFF OMITTED] T9578.040 [GRAPHIC] [TIFF OMITTED] T9578.041 [GRAPHIC] [TIFF OMITTED] T9578.042 [GRAPHIC] [TIFF OMITTED] T9578.043 [GRAPHIC] [TIFF OMITTED] T9578.044 [GRAPHIC] [TIFF OMITTED] T9578.045 [GRAPHIC] [TIFF OMITTED] T9578.046 [GRAPHIC] [TIFF OMITTED] T9578.047 [GRAPHIC] [TIFF OMITTED] T9578.048 [GRAPHIC] [TIFF OMITTED] T9578.049 [GRAPHIC] [TIFF OMITTED] T9578.050 [GRAPHIC] [TIFF OMITTED] T9578.051 [GRAPHIC] [TIFF OMITTED] T9578.052 [GRAPHIC] [TIFF OMITTED] T9578.053 [GRAPHIC] [TIFF OMITTED] T9578.054 [GRAPHIC] [TIFF OMITTED] T9578.055 [GRAPHIC] [TIFF OMITTED] T9578.056 [GRAPHIC] [TIFF OMITTED] T9578.057 [GRAPHIC] [TIFF OMITTED] T9578.058 [GRAPHIC] [TIFF OMITTED] T9578.059 [GRAPHIC] [TIFF OMITTED] T9578.060 [GRAPHIC] [TIFF OMITTED] T9578.061 [GRAPHIC] [TIFF OMITTED] T9578.062 [GRAPHIC] [TIFF OMITTED] T9578.063 [GRAPHIC] [TIFF OMITTED] T9578.064 [GRAPHIC] [TIFF OMITTED] T9578.065 [GRAPHIC] [TIFF OMITTED] T9578.066 [GRAPHIC] [TIFF OMITTED] T9578.067 [GRAPHIC] [TIFF OMITTED] T9578.068 [GRAPHIC] [TIFF OMITTED] T9578.069 [GRAPHIC] [TIFF OMITTED] T9578.070 [GRAPHIC] [TIFF OMITTED] T9578.071 [GRAPHIC] [TIFF OMITTED] T9578.072 [GRAPHIC] [TIFF OMITTED] T9578.073 [GRAPHIC] [TIFF OMITTED] T9578.074 [GRAPHIC] [TIFF OMITTED] T9578.075 [GRAPHIC] [TIFF OMITTED] T9578.076 [GRAPHIC] [TIFF OMITTED] T9578.077 [GRAPHIC] [TIFF OMITTED] T9578.078 [GRAPHIC] [TIFF OMITTED] T9578.079 [GRAPHIC] [TIFF OMITTED] T9578.080 [GRAPHIC] [TIFF OMITTED] T9578.081 [GRAPHIC] [TIFF OMITTED] T9578.082 [GRAPHIC] [TIFF OMITTED] T9578.083 [GRAPHIC] [TIFF OMITTED] T9578.084 [GRAPHIC] [TIFF OMITTED] T9578.085 [GRAPHIC] [TIFF OMITTED] T9578.086 [GRAPHIC] [TIFF OMITTED] T9578.087 [GRAPHIC] [TIFF OMITTED] T9578.088 [GRAPHIC] [TIFF OMITTED] T9578.089 [GRAPHIC] [TIFF OMITTED] T9578.090 [GRAPHIC] [TIFF OMITTED] T9578.091 [GRAPHIC] [TIFF OMITTED] T9578.092 [GRAPHIC] [TIFF OMITTED] T9578.093 [GRAPHIC] [TIFF OMITTED] T9578.094 [GRAPHIC] [TIFF OMITTED] T9578.095 [GRAPHIC] [TIFF OMITTED] T9578.096 [GRAPHIC] [TIFF OMITTED] T9578.097 [GRAPHIC] [TIFF OMITTED] T9578.098 [GRAPHIC] [TIFF OMITTED] T9578.099 [GRAPHIC] [TIFF OMITTED] T9578.100 [GRAPHIC] [TIFF OMITTED] T9578.101 [GRAPHIC] [TIFF OMITTED] T9578.102 [GRAPHIC] [TIFF OMITTED] T9578.103 [GRAPHIC] [TIFF OMITTED] T9578.104 [GRAPHIC] [TIFF OMITTED] T9578.105 [GRAPHIC] [TIFF OMITTED] T9578.106 [GRAPHIC] [TIFF OMITTED] T9578.107 [GRAPHIC] [TIFF OMITTED] T9578.108 [GRAPHIC] [TIFF OMITTED] T9578.109 [GRAPHIC] [TIFF OMITTED] T9578.110 [GRAPHIC] [TIFF OMITTED] T9578.111 [GRAPHIC] [TIFF OMITTED] T9578.112 [GRAPHIC] [TIFF OMITTED] T9578.113 [GRAPHIC] [TIFF OMITTED] T9578.114 [GRAPHIC] [TIFF OMITTED] T9578.115 [GRAPHIC] [TIFF OMITTED] T9578.116 [GRAPHIC] [TIFF OMITTED] T9578.117 [GRAPHIC] [TIFF OMITTED] T9578.118 [GRAPHIC] [TIFF OMITTED] T9578.119 [GRAPHIC] [TIFF OMITTED] T9578.120 [GRAPHIC] [TIFF OMITTED] T9578.121 [GRAPHIC] [TIFF OMITTED] T9578.122 [GRAPHIC] [TIFF OMITTED] T9578.123 [GRAPHIC] [TIFF OMITTED] T9578.124 [GRAPHIC] [TIFF OMITTED] T9578.125 [GRAPHIC] [TIFF OMITTED] T9578.126 [GRAPHIC] [TIFF OMITTED] T9578.127 [GRAPHIC] [TIFF OMITTED] T9578.128 [GRAPHIC] [TIFF OMITTED] T9578.129 [GRAPHIC] [TIFF OMITTED] T9578.130 [GRAPHIC] [TIFF OMITTED] T9578.131 [GRAPHIC] [TIFF OMITTED] T9578.132 [GRAPHIC] [TIFF OMITTED] T9578.133 [GRAPHIC] [TIFF OMITTED] T9578.134 [GRAPHIC] [TIFF OMITTED] T9578.135 [GRAPHIC] [TIFF OMITTED] T9578.136 [GRAPHIC] [TIFF OMITTED] T9578.137 [GRAPHIC] [TIFF OMITTED] T9578.138 [GRAPHIC] [TIFF OMITTED] T9578.139 [GRAPHIC] [TIFF OMITTED] T9578.140 [GRAPHIC] [TIFF OMITTED] T9578.141 [GRAPHIC] [TIFF OMITTED] T9578.142 [GRAPHIC] [TIFF OMITTED] T9578.143 [GRAPHIC] [TIFF OMITTED] T9578.144 [GRAPHIC] [TIFF OMITTED] T9578.145 [GRAPHIC] [TIFF OMITTED] T9578.146 [GRAPHIC] [TIFF OMITTED] T9578.147 [GRAPHIC] [TIFF OMITTED] T9578.148 [GRAPHIC] [TIFF OMITTED] T9578.149 [GRAPHIC] [TIFF OMITTED] T9578.150 [GRAPHIC] [TIFF OMITTED] T9578.151 [GRAPHIC] [TIFF OMITTED] T9578.152 [GRAPHIC] [TIFF OMITTED] T9578.153 [GRAPHIC] [TIFF OMITTED] T9578.154 [GRAPHIC] [TIFF OMITTED] T9578.155 [GRAPHIC] [TIFF OMITTED] T9578.156 [GRAPHIC] [TIFF OMITTED] T9578.157 [GRAPHIC] [TIFF OMITTED] T9578.158 [GRAPHIC] [TIFF OMITTED] T9578.159 [GRAPHIC] [TIFF OMITTED] T9578.160 [GRAPHIC] [TIFF OMITTED] T9578.161 [GRAPHIC] [TIFF OMITTED] T9578.162 [GRAPHIC] [TIFF OMITTED] T9578.163 [GRAPHIC] [TIFF OMITTED] T9578.164 [GRAPHIC] [TIFF OMITTED] T9578.165 [GRAPHIC] [TIFF OMITTED] T9578.166 [GRAPHIC] [TIFF OMITTED] T9578.167 [GRAPHIC] [TIFF OMITTED] T9578.168 [GRAPHIC] [TIFF OMITTED] T9578.169 [GRAPHIC] [TIFF OMITTED] T9578.170 [GRAPHIC] [TIFF OMITTED] T9578.171 [GRAPHIC] [TIFF OMITTED] T9578.172 [GRAPHIC] [TIFF OMITTED] T9578.173 [GRAPHIC] [TIFF OMITTED] T9578.174 [GRAPHIC] [TIFF OMITTED] T9578.175 [GRAPHIC] [TIFF OMITTED] T9578.176 [GRAPHIC] [TIFF OMITTED] T9578.177 [GRAPHIC] [TIFF OMITTED] T9578.178 [GRAPHIC] [TIFF OMITTED] T9578.179 [GRAPHIC] [TIFF OMITTED] T9578.180 [GRAPHIC] [TIFF OMITTED] T9578.181 [GRAPHIC] [TIFF OMITTED] T9578.182 [GRAPHIC] [TIFF OMITTED] T9578.183 [GRAPHIC] [TIFF OMITTED] T9578.184 [GRAPHIC] [TIFF OMITTED] T9578.185 [GRAPHIC] [TIFF OMITTED] T9578.186