[House Hearing, 110 Congress] [From the U.S. Government Printing Office] THE RECENT SALMONELLA OUTBREAK: LESSONS LEARNED AND CONSEQUENCES TO INDUSTRY AND PUBLIC HEALTH ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS SECOND SESSION __________ JULY 31, 2008 __________ Serial No. 110-142 Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov __________ [GRAPHIC NOT AVAILABLE IN TIFF FORMAT] U.S. GOVERNMENT PRINTING OFFICE 61-557 PDF WASHINGTON: 2011 ___________________________________________________________________________ For sale by the Superintendent of Documents, U.S. Government Printing Office, http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-mail, [email protected] COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman HENRY A. WAXMAN, California JOE BARTON, Texas EDWARD J. MARKEY, Massachusetts Ranking Member RICK BOUCHER, Virginia RALPH M. HALL, Texas EDOLPHUS TOWNS, New York FRED UPTON, Michigan FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida BART GORDON, Tennessee NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky ANNA G. ESHOO, California BARBARA CUBIN, Wyoming BART STUPAK, Michigan JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico GENE GREEN, Texas JOHN SHADEGG, Arizona DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING, Vice Chair Mississippi LOIS CAPPS, California VITO FOSSELLA, New York MIKE DOYLE, Pennsylvania ROY BLUNT, Missouri JANE HARMAN, California STEVE BUYER, Indiana TOM ALLEN, Maine GEORGE RADANOVICH, California JAN SCHAKOWSKY, Illinois JOSEPH R. PITTS, Pennsylvania HILDA L. SOLIS, California MARY BONO MACK, California CHARLES A. GONZALEZ, Texas GREG WALDEN, Oregon JAY INSLEE, Washington LEE TERRY, Nebraska TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey MIKE ROSS, Arkansas MIKE ROGERS, Michigan DARLENE HOOLEY, Oregon SUE WILKINS MYRICK, North Carolina ANTHONY D. WEINER, New York JOHN SULLIVAN, Oklahoma JIM MATHESON, Utah TIM MURPHY, Pennsylvania G.K. BUTTERFIELD, North Carolina MICHAEL C. BURGESS, Texas CHARLIE MELANCON, Louisiana MARSHA BLACKBURN, Tennessee JOHN BARROW, Georgia BARON P. HILL, Indiana DORIS O. MATSUI, California ______ Professional Staff Dennis B. Fitzgibbons, Chief of Staff Gregg A. Rothschild, Chief Counsel Sharon E. Davis, Chief Clerk David L. Cavicke, Minority Staff Director 7_____ Subcommittee on Oversight and Investigations BART STUPAK, Michigan, Chairman DIANA DeGETTE, Colorado JOHN SHIMKUS, Illinois CHARLIE MELANCON, Louisiana Ranking Member Vice Chairman ED WHITFIELD, Kentucky HENRY A. WAXMAN, California GREG WALDEN, Oregon GENE GREEN, Texas TIM MURPHY, Pennsylvania MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee JAY INSLEE, Washington JOE BARTON, Texas (ex officio) JOHN D. DINGELL, Michigan (ex officio) (ii) C O N T E N T S ---------- Page Hon. Bart Stupak, a Representative in Congress from the State of Michigan, opening statement.................................... 1 Hon. John Shimkus, a Representative in Congress from the State of Illinois, opening statement.................................... 4 Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement................................. 5 Hon. Marsha Blackburn, a Representative in Congress from the State of Tennessee, opening statement.......................... 7 Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement................................. 8 Hon. Joe Barton, a Representative in Congress from the State of Texas, opening statement....................................... 10 Prepared statement........................................... 11 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement.............................. 12 Hon. Tim Murphy, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement................ 14 Witnesses Charles H. Bronson, Commissioner of Agriculture, Department of Agriculture and Consumer Services, State of Florida............ 16 Prepared statement........................................... 18 A.G. Kawamura, Secretary, Department of Food and Agriculture, State of California............................................ 21 Prepared statement........................................... 23 Reginald L. Brown, Executive Vice President, Florida Tomato Growers Exchange............................................... 26 Prepared statement........................................... 27 Edward Beckman, President, California Tomato Farmers............. 31 Prepared statement........................................... 33 Parker Booth, President, Delta Prepack, Inc. and Ace Tomato Co., Inc............................................................ 68 Prepared statement........................................... 70 Thomas E. Stenzel, President and Chief Executive Officer, United Fresh Produce Association...................................... 82 Prepared statement........................................... 84 William K. Hubbard, Senior Advisor, Coalition for a Stronger FDA. 91 Prepared statement........................................... 93 David W.K. Acheson, M.D., Assistant Commissioner for Food Protection, Food and Drug Administration, U.S. Department of Health and Human Services...................................... 130 Prepared statement........................................... 133 Answers to submitted questions............................... 291 Lonnie J. King, D.V.M., Director, National Center for Zoonotic, Vector-Borne, and Enteric Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services... 150 Prepared statement........................................... 153 Kirk Smith, D.V.M., Ph.D., Supervisor, Foodborne, Vectorborne, and Zoonotic Disease Unit, Acute Disease Investigation and Control Section, Department of Health, State of Minnesota...... 170 Prepared statement........................................... 171 Timothy Jones, M.D., State Epidemiologist, Communicable and Environmental Disease Services, Department of Health, State of Tennessee...................................................... 173 Prepared statement........................................... 174 Michael R. Taylor, J.D., Research Professor of Health Policy, The George Washington University, School of Public Health and Health Services................................................ 203 Prepared statement........................................... 205 Henry Giclas, Vice President, Strategic Planning, Science and Technology, Western Growers Association........................ 233 Prepared statement........................................... 235 Donna Garren, Ph.D., Vice President, Health and Safety Regulatory Affairs, National Restaurant Assocation........................ 245 Prepared statement........................................... 248 Robert E. Brackett, Ph.D., Senior Vice President and Chief Science and Regulatory Affairs Officer, Grocery Manufacturers Association.................................................... 260 Prepared statement........................................... 262 Submitted Material Salmonella Saintpaul Outbreak Timeline........................... 282 Subcommittee exhibit binder...................................... 293 THE RECENT SALMONELLA OUTBREAK: LESSONS LEARNED AND CONSEQUENCES TO INDUSTRY AND PUBLIC HEALTH ---------- THURSDAY, JULY 31, 2008 House of Representatives, Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, Washington, D.C. The committee met, pursuant to call, at 10:01 a.m., in room 2123, Rayburn House Office Building, Hon. Bart Stupak (chairman of the subcommittee) presiding. Present: Representatives Stupak, DeGette, Schakowsky, Inslee, Dingell (ex officio), Shimkus, Murphy, Burgess, Blackburn, and Barton (ex officio). Staff Present: Scott Schloegel, John Sopko, Chris Knauer, Kevin Barstow, Calvin Webb, Alan Slobodin, Krista Carpenter, Whitney Drew, and Kyle Chapman. OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Mr. Stupak. This meeting will come to order. Today we have a hearing titled ``The Recent Salmonella Outbreak: Lessons Learned and Consequences to Industry and Public Health.'' Each member will be recognized for a 5-minute opening statement. I will begin. Since the 110th Congress began in January 2007, this subcommittee has been investigating the adequacy of the Food and Drug Administration's efforts to protect Americans from unsafe food. Today we hold the subcommittee's ninth hearing regarding the safety and security of the Nation's food supply. The purpose of today's hearing is to examine the events surrounding a recent Salmonella Saintpaul outbreak. We will consider the implications to public health and industry and will examine what lessons can be learned to better safeguard our food supply. Since April, at least 1,304 people in 43 States, the District of Columbia, and Canada have been infected with Salmonella Saintpaul. These illnesses have resulted in at least 252 hospitalizations and may have been a contributing factor in two deaths. This outbreak is one of the largest outbreaks of Salmonella ever in the United States, and based on the number of confirmed cases it's the largest food-borne outbreak in the last decade. The Centers for Disease Control and Prevention, CDC, and the Food and Drug Administration, FDA, have struggled to identify the cause of Salmonella outbreak. Originally CDC and FDA identified tomatoes as the most likely cause of the outbreak. However, as the outbreak continued and the number of illnesses soared the FDA was unable to definitively identify tomatoes as the source of contamination. In late June CDC expanded its epidemiological investigation to include food items that are commonly served in combination with tomatoes. This study found that people who became ill were more likely to have recently consumed raw tomatoes, fresh jalapeno peppers, and fresh cilantro. However, the CDC still could not determine the exact cause of the outbreak. Finally, on July 21, nearly 2 months after the outbreak was first discovered, the FDA announced a significant break in its investigation when they confirmed the presence of Salmonella Saintpaul in a Mexican-grown jalapeno pepper. The jalapeno had the same Salmonella genetic fingerprint as the strain linked to the outbreak. Despite this discovery in jalapenos, the FDA still refused to rule out tomatoes as the original source of the outbreak, which has angered many tomato growers. Today we will examine why it took the FDA, CDC and State public health agencies so long to identify jalapeno peppers as a source of Salmonella Saintpaul. Further, we will explore what lessons for industry and government should be garnered as a result of this outbreak. Perhaps most importantly we will try to determine which aspects of this outbreak investigation worked well, and which failed so that regulators, and the affected industry will be better prepared to rapidly respond to future outbreaks. For example, we will examine a portion of the Bioterrorism Act of 2002 which was designed to ensure the traceability of food. The act directed Secretary of Health and Human Services to issue regulations regarding the establishment and maintenance of records by most people and companies that manufacture, possess, pack, transport, distribute or receive food. Most notably exempt from this requirement are farms and restaurants. The regulation requires that records must be kept to allow federal investigators to identify the immediate previous sources and subsequent recipients of food in order to be able to quickly respond to threats to our food supply. However, in discussions with committee staff, Dr. David Acheson, FDA's Assistant Commissioner for Food Protection, otherwise known as the Food Czar, stated that the Bioterrorism Act did not function as intended during this outbreak. Because the Bioterrorism Act does not require a particular format for maintaining records, most food companies have their own unique system of recordkeeping which, according to FDA officials, has caused significant delays in FDA's trace-back investigation. While FDA has ultimately been able to trace back commodities associated with this outbreak it has been too time consuming of a process, requiring countless hours trying to link one company's records to the next. Today we will explore what specific problems FDA had in its trace-back investigation and whether alterations to the Bioterrorism Act or other additional regulations are needed to allow federal investigators to quickly trace back suspected commodities during an outbreak. We will also explore what the industry can do to maintain traceability of its products. While there has been discussion by FDA and the media that loose products, like tomatoes, are difficult to trace due to their complex processing and distribution chain, some of the industry maintain that such commodities are rapidly traceable from the farm to the end user. Indeed, some tomato companies visited by committee staff did provide evidence that tomatoes could be rapidly traced back if the need arose. However, these sophisticated systems appear to conflict with statements by FDA officials who claim that tracing this commodity has often been a time-consuming and daunting task. Today we will discuss whether there are particular systems that can be adapted by industry to enhance traceability, particularly for high risk commodities. Finally we will also hear a host of criticism from industry directed at the FDA and CDC for the way they conducted its outbreak investigation. For example, we will hear that the FDA often did not share or solicit critical data and other information from food safety agencies. We will hear that the way State health agencies interact and share data with key federal agencies such as the FDA and CDC is often inefficient, overly bureaucratic and sometimes even counterproductive. We will hear that by failing to adequately coordinate with key State agencies both FDA And CDC missed important opportunities to leverage scarce federal resources with State resources to conduct investigation and field work related to the investigation. We will hear that neither CDC nor FDA worked closely enough with State agencies to understand key produce distribution patterns and, if they had, they would have realized early that based on geographic distribution patterns of the illness the source of the Salmonella was likely not from Florida. Finally, we will hear that because there were over 3,000 local health departments and 50 State health departments working under different public health laws there is a tremendous variability in the capacity to respond to these outbreaks which can have produced consequences on the ability to pinpoint a contamination source. These and other troubling issues related to this outbreak continued to be uncovered as we move forward with this investigation. While we understand the FDA's and CDC's investigation into this outbreak is ongoing, it's important to find answers and solutions to the key failures that have been identified up to this point. At a minimum, the FDA and the CDC must convene and independent post-mortem task force which includes local, State, federal, scientific and industry officials related to this outbreak to study which features of the investigation broke down and how the system can be improved. While this Salmonella outbreak has sickened scores of people and caused great economic damage to the produce industry, we are fortunate that this does not appear to be an intentional contamination of our food supply. If we do not learn from this case and rapidly improve our food safety system we will be doomed to repeat the failures of the current outbreak. The American public deserves better from industry and our State, local, and Federal agencies. That completes my opening. I will next turn to Mr. Shimkus, the Ranking Member of the subcommittee for his opening statement please, sir. OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS Mr. Shimkus. Thank you, Mr. Chairman. I want to welcome this panel and the succeeding panels to follow. This is our ninth hearing we have held on food safety this Congress to identify ways to ensure the safety and security of our nation's food supply. At the beginning of our last hearing in June, grocers and restaurants nationwide had begun pulling tomatoes from the shelves and menus at great economic cost until the cause of the Salmonella outbreak could be identified. Since then, 2 months after FDA's initial notice, not one contaminated tomato has been found. Instead, the outbreak strain of Salmonella Saintpaul was originally traced back to a jalapeno pepper that was grown in Mexico and imported and distributed through a warehouse in Texas. Yesterday afternoon the FDA learned that the same genetic strain of the Salmonella that was found in the serrano pepper on a different farm in Mexico and in a nearby water reservoir. Today nearly 1,300 illnesses have been reported in over 43 States, and local State and national public health officials and regulators have been working to protect Americans during the outbreak. Outbreaks of this magnitude cause serious concern and warrant our close attention to help better prepare our nation for the future. Today we will explore the dynamics of the marketplace in which federal agencies are trying to do the right thing and prevent harm to consumers while their decisions often result in economic losses to the industry. Witnesses from the tomato industry will discuss their frustration of how the outbreak gets handled and explain the effect the government's actions had on consumer confidence and industry revenues. A question to consider today is: Is there a way to limit unnecessary collateral damage to the industry, and effectively address a food-borne illness outbreak? A lot of the hearing will focus on traceability. Trace-back is an important tool used to rapidly and accurately identify the source of contamination. This issue was supposed to be addressed in the Bioterrorism Preparedness and Response Act of 2002. The act directed the Secretary of Health and Human Services to issue regulations regarding records kept by those who manufacture, process, pack, transfer, distribute, receive, hold or import food. Current regulations required that records must be kept to allow federal investigators to identify the immediate previous sources and subsequent recipients of food. This is known as the one step forward, one step back. In light of recent outbreaks and events it may be time to evaluate the intent of the act and determine if clarification or additional regulations are needed to improve our trace-back ability. Witnesses today from different states and industry will discuss their current practices and proposals to establish more robust traceability systems. FDA's current traceability system is not without flaws. We need to identify and understand the system's limitations and explore and implement realistic ways to make it faster and more cost efficient. A critical part of this hearing is how a contaminated product or commodity is identified in the first place. It seems to me that without reliable information about the contaminated product or commodity, traceability will be ineffective. Among today's witnesses are two epidemiologists and a representative from the Centers for Disease Control. I hope they can explain the process of identifying suspected contaminated commodities and highlight the strengths and the weaknesses of our current system. I want to understand the role epidemiology plays in relation to nationwide food-borne illness outbreaks. If there are gaps in epidemiology that we can avoid and traceability is only as good as the science that is guiding it, we might want to focus our limited resources to improving the science and statistics and not in requiring more regulations. We may not be able to create a perfect system but we must have a more reliable and efficient one. There is a lot to be learned from this outbreak, and a thorough post-mortem should be conducted by FDA and CDC with input from local and State governments and the affected industries. We need to determine where the breakdown in the epidemiology, and in trace-back, and interagency, and intergovernment communication occurred and then decide how we need to allocate our resources to provide the most protection to Americans against food-borne illnesses. Finally, if there are legal walls blocking the States, CDC, and FDA from fully communicating and cooperating during an outbreak investigation, then those walls need to be torn down. We have 16 witnesses here to help explore these issues and discuss possible solutions. And I look forward to hearing their testimony. Again, welcome to this panel and the succeeding panels. Mr. Stupak. I thank the gentleman. Ms. DeGette for an opening statement, please. OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO Ms. DeGette. Thank you, Mr. Chairman. Mr. Chairman, as a mom I have spent a lot of time with people who are like me, people who are trying to raise their kids and do the right things. And, unfortunately, even though in some prior life they may have been very interested in politics and public policy, they are more interested in the safety of their kids and making sure their families work. But they have been perking up lately because there have been a whole series of threats to their family life and to the safety of their kids. We dealt with the consumer product safety yesterday and the toy safety, but with food it has just been one thing after another the last few years. First we had the spinach recall, then we had the peanut butter recall, then we had the pet food recall. And the saga of the Salmonella outbreak has been going on now since last spring. And, frankly, this is the kind of thing that people really take notice of because they think that the main job of government is to protect their families' safety. And, frankly, we could be doing that. We have the technology. In mid-April people started getting sick in this country. Then in late May the CDC and the State health departments identified that it was Salmonella Saintpaul. But not until June did the FDA warn consumers not to eat red tomatoes. And so consumers all around America quit eating tomatoes. And what that did was that caused tons and tons of tomatoes to be discarded at a cost of millions and millions of dollars to the tomato industry. But now we learn in July, 4 months later, that, oh, it is probably jalapeno and serrano peppers. This makes consumers very nervous, and rightfully so. And the thing is, it does not have to be this way. Many of you know that I have been working on food traceability issues now for about 6 years. And I have legislation, H.R. 3485, which would require the USDA and the FDA to get moving on a system to track food products throughout the supply chain. For a long time I found a very difficult time trying to convince people that we should have traceability. They said, we cannot afford to do that. And I am here to tell you today with the loss of consumer confidence with the latest outbreak I think we cannot afford not to do traceability. We have the technology to do traceability for produce, for processed foods, and for other types of foods. In fact, as we will hear today, the tomato industry and many other industries are using traceability right now. We have the technology to trace a tomato from field to fork, but we do not do it in any kind of organized way nationally. So while you might be able to trace a tomato in one particular industry, you cannot do it across industries, and you cannot do it on a national level. And so if we institute simply voluntary trace-backs, those programs will still have cracks and all of the participants will suffer if an outbreak occurs. On the other hand, if we have a national system of traceability where we might not have just one system in place but the systems are interoperable, that we will be able to effectively trace outbreaks. This will both protect consumers' health and it will protect business because we will not have over-broad recalls and we will not be losing consumer confidence in the system. To me it is an essential part of any food safety legislation that we might do. Finally, I think all of us up here want to know what we could be doing better from a public health standpoint to trace outbreaks once we identify that there's a problem. Is there some better way we could communicate between health departments and the CDC? Is there some better way we could communicate between the CDC and the FDA and the other various regulatory agencies? This is not rocket science. We have technology to do it. We have the know-how to do it. We simply need to have the will to make it work. And, Mr. Chairman, I am hoping this investigative hearing will go a long way towards making all of these things work together to protect consumers from unnecessary disease in foods and other consumer products. With that I yield back. Mr. Stupak. Thank you. Ms. Blackburn for opening statement please. OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE Ms. Blackburn. Thank you, Mr. Chairman. I want to thank you for calling the hearing today. And I would like to recognize Dr. Tim Jones who is an epidemiologist from the Tennessee Department of Health. He is going to be a witness before us today. I am pleased that he is here with us. As our witnesses can tell, we are fully aware, everybody in America is aware of the food contamination issues that are before us. And this time it is the largest Salmonella outbreak in our nation's history and it has affected tomatoes, it has affected jalapenos and the supply of those. And while the various federal and State agencies work to pinpoint the source of the dangerous bacteria too much time passed at the peril of public health and hundreds of millions of dollars of produce was lost. And for those of us that have agricultural groups and farms in our districts this is something that we have heard so very much about as we have met with these individuals. Plus, this committee has spent countless hours listening to testimony on FDA's inability to protect the nation's food supply as a result of limited resources, insufficient personnel, lack of interagency communication, and a lack of best practices to streamline safety review efforts. And I am still waiting to hear what those best practices are and looking forward to hearing from the FDA what their best practices are, how they follow these in their communications and their efforts to streamline safety review efforts. I will welcome that information when it makes it to my desk. I think it is indeed ironic that we are sitting here today for another investigative hearing to scrutinize the nation's food safety review capabilities when yesterday this body, the House of Representatives, took a vote to force the ill-equipped FDA to regulate tobacco products. The FDA is saddled with so many unfunded mandates that placing additional stress on a broken federal bureaucracy will eventually lead to disaster. And I hope that this is not lost on my colleagues and on those of you that are here. We are talking about an FDA that cannot get information from one division to another and cannot seem to figure out how in the world to police food and drugs and yet, indeed, we are talking about tobacco. For the past few months federal, State and local officials, as well as the industry, were all involved in the Salmonella investigation. I am looking forward to testimony that explains the complex flow of information, or maybe it is the lack of flow of information between all the stakeholders, the lack of clearly-established protocols and lines of communication between different jurisdictions in the industry and the agency seems to be troubling. It is troubling to me. I would think it is troubling to some of you. And as a result from all of this miscommunication and lack of established flow of information the tomato industry was devastated and public panic ensued. I believe the hearing will be a good opportunity to learn what worked and what changes need to be made to protect consumers in the industry from future outbreaks. It is critical that a coordinated outbreak response further evolve to protect Americans and to ensure consumer confidence. As I have said in the past, the FDA needs to shift its focus from reacting to food safety breaches following contamination and instead implement policies to prevent food safety problems before they occur. The recent outbreak is a clear example of defensive action and a lack of best practices to efficiently solve this issue. I thank the Chairman and I yield the balance of my time. Mr. Stupak. Thank you. Mr. Dingell, Chairman of the full committee, for an opening statement. OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Mr. Dingell. Mr. Chairman, thank you. I congratulate you on the vigor with which you are approaching the problem before us today. I note this is the ninth hearing on the safety and security of the nation's food supply and, interestingly enough, on the inadequacies of Food and Drug and the resources of that agency. There are good people there. There are not enough of them. They do not have the money. They do not have the resources. They do not have the leadership. And they do not have the support of the Administration. Today's hearing will examine those matters, and in the light of a major food contamination outbreak involving Salmonella Saintpaul. This has again shaken public confidence in Food and Drug and our food industry and has devastated an important industry. Today we are going to learn how important it is not just to the public whose health is at risk but how important it is for the industry because without an adequate way of addressing the problem of ensuring safety of the nation's food supply, confidence in that industry and the costs to that industry are going to be at levels and places that that industry cannot tolerate. Since April, at least 1,304 people in 43 States, the District of Columbia, and Canada have been infected with Salmonella Saintpaul. These illnesses resulted in 252 hospitalizations or more, and contributed to at least two deaths. This is one of the largest outbreaks of Salmonella in the United States. And based on the number of confirmed cases, the largest food-borne outbreak in the past 10 years. While it has caused personal and financial tragedy to many, this outbreak should also be another wake-up call to everyone in our system who are responding to unintentional or intentional contamination of the nation's food supply and pointing out that that ability on our national capability is very much at risk and very much wanting. Our investigation to date has uncovered, among other things: 1) a breakdown in the way the Centers for Disease Control and Prevention, CDC, and the Food and Drug Administration shared critical data with key State agencies; 2) The failure of FDA and CDC to leverage state resources; and 3) More than 3,000 State and local health departments working without any adequate coordination with each other or with the federal government, and with grotesquely limited resources considering the needs of the times. And they are, I note, supposed to serve as an identifying agent to help bring to our attention the existence and the cause of outbreaks like this. Finally, Mr. Chairman, we are going to hear today that key sections of the Bioterrorism Act of 2002 which was designed to ensure the rapid traceability of foods in a situation such as this has failed to perform as intended. And I note in good part because the system cannot talk to each other, it does not have resources, and it does not have leadership and proper support from the agencies involved, including the Department of Homeland Security. This act directed the Secretary of Health and Human Services to issue specific recordkeeping requirements to allow federal investigators to quickly respond to threats to our national food supply. We have learned, however, that key portions of this act designed to allow for rapid traceability do not work. While the FDA was ultimately able to trace commodities associated with this outbreak, the process was slow and cumbersome. And it reminded me very much of the kind of Keystone Cops situation which we saw when we had the Chilean grapes situation. And this is interesting to note that what should have taken hours or days has taken months or more. Today we will not only explore the failures of FDA and CDC, but also what industry can and should do to improve the traceability of its products. And we are going to have to explore what we have to do to see to it that the money and the resources are available for this and who is going to pay for that in times of a tight budget. While some in the FDA have argued that loose produce like tomatoes are too difficult to trace, some of our industry witnesses will describe systems currently in place that can rapidly trace their products. And we are going to want to hear why it is that Food and Drug cannot or will not or does not support efforts to get us to the point where we could properly address the traceability of products. We can and must learn from industry. And rather than be at odds with the government on improved safety, the industry must be our partner. And we are going to find out whether they want to do that today or not. If parts of the tomato industry can develop an efficient traceability system, why cannot other parts of the food industry do likewise? Why cannot FDA mandate it? And why not the industry voluntarily adopt such a thoughtfully crafted and well-done system? Perhaps it is time to revisit what additional changes to existing regulations may be required to achieve this goal. We have a number of outstanding witnesses today. I want to thank them for coming forward. And I look forward to hearing their views on what needs to be done to prevent more debacles of this sort which seem to occur on a weekly or daily basis. With the help of the industry I believe we can restore public confidence and the safety of our food supply, we can prevent suffering, loss and hurt and death to our people, and we can prevent significant damage to industry at all levels for want of the ability to maintain public confidence and to properly trace and manage our nation's food supply. And we need to see what we have to do to see to it that the regulatory agencies have the resources, the willingness, the enthusiasm and the leadership to protect our Nation's food supply. I thank you, Mr. Chairman. Mr. Stupak. Thank you, Mr. Chairman. Mr. Barton for an opening statement please. OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Barton. Thank you, Mr. Chairman. Thanks for the prompt response to this problem and the hearing today and all our witnesses for being here. We have invited 16 witnesses to tell us what went right, and what went wrong in the search for the source of the latest Salmonella outbreak in fresh produce. Nearly everybody seems to think that more went wrong than went right, and I think we need to explore the complex reality if we are really going to try to fix the problem. First of all we want to know why it took so long to figure out that it was Mexican peppers instead of American tomatoes that were making people sick.Many innocent farmers in the United States lost thousands and thousands of dollars because we at first identified tomatoes, and it hurt their crop. You do not have to be a detective to know that the initial investigation did not really help anybody. As I just said, it did harm to a lot of people. I understand that the investigators followed clues until they found the culprit but it is arguable that our public health agencies should have found the source of contamination much sooner than they did. Identifying tomatoes I believe according to this timeline, Mr. Chairman, in early June, and we did not really begin to look at or identify the jalapenos until late June. And it was not until July that Minnesota authorities actually pinpointed the jalapenos as the source of the Salmonella-induced illnesses. So that is a month that really hurt in terms of the tomato crop situation.The point of doing trace-backs, spending millions of taxpayer dollars is to contain an outbreak quickly and prevent any future contamination. The first response, unfortunately, to this outbreak fingered the tomato industry and caused growers all across America to suffer a devastating loss. This hearing is also going to examine a portion of the Bioterrorism Preparedness and Response Act of 2002 which required the Food and Drug Administration to establish procedures on trace-back and recordkeeping. The rationale behind passing the act was to enable federal investigators to have access to records that could help trace-back and lead quickly to the source of contamination during an outbreak. This is important. To meet these regulations the records kept by those who manufacture, process, pack, transport, distribute, receive, hold or import food need to clearly identify the immediate previous source and subsequent recipient of that food. If the records that are kept by industry are not meeting these standards and the trace-back and trace-forward process is not being achieved then industry needs to tell us and the regulators need to find a way to improve compliance. However, if industry is meeting these standards and it is the regulations themselves that are limiting our regulators, then perhaps a change in the law or the regulation may be needed. I am really not interested in trying to find a bad guy in this story. I want to get it right. If the current system is broke, let us figure out what is wrong with it and fix it together. If it just needs a tune-up, then let us start tuning it up. Mr. Chairman, I have three more pages of specifics but I will submit those for the record. Let me simply say that this is an important hearing, and I know that my folks down in Texas are very interested in this. And as I just said, let us figure what is broke and fix it or let us figure out what needs to be tuned up and tune it up. Thank you, Mr. Chairman. [The information follows:] Prepared statement of Hon. Joe Barton Thank you, Mr. Chairman. The Committee has invited 16 witnesses here today to tell us what went right and what went wrong in the search for the source in the latest salmonella outbreak in fresh produce. Nearly everybody thinks more went wrong than right, but we need to explore the complex realities if we're going to fix the problem. For starters, we want to know why it took so long to figure out that Mexican peppers instead of American tomatoes were making people sick that innocent tomato farmers lost their crops and lost their shirts. You don't have to be a detective to know that the initial investigation here helped nobody and harmed many. I understand that investigators follow clues until they get to the culprit, but our public health agencies should have found the source of contamination much sooner than they did. The point of doing the trace-back and spending millions of taxpayers dollars is to contain the outbreak and prevent future illness. The first response to this outbreak fingered the tomato industry and caused growers all across America to suffer a devastating loss of consumer confidence and revenues. We cannot let this happen each time a food-borne illness outbreak is identified. This hearing will also examine a portion of the Bioterrorism Preparedness and Response Act of 2002, which required the Food and Drug Administration to establish procedures on trace-back and record-keeping. The rationale behind passing the Act was to enable Federal investigators to have access to records that could help ``trace-back'' and lead to the source of contamination during an outbreak. To meet regulations, the records kept by those who manufacture, process, pack, transport, distribute, receive, hold or import food need to clearly identify the immediate previous sources and subsequent recipients of food. If the records kept by industry are not meeting these standards, and the trace-back and trace-forward process is not being achieved, then industry and regulators need to find ways to improve compliance. However, if industry is meeting these standards and it is the regulations themselves that are limiting our regulators, then a change in law or regulation may be needed. Concerns have also been raised regarding the barriers to and lack of sharing data and information between local, state and federal agencies and industry. I want to know what these barriers are. Are state and federal agencies and governments taking unreasonable positions under the Bioterrorism Act concerning sharing information? Do we need to clarify the law? Do we need to create a carve-out in the regulations to allow for information sharing when a serious public health threat exists? We are in the business of legislating, and we want to pass laws that enable our government to work seamlessly with local, state, and inter-agency personnel to respond, react, and coordinate quickly to contain an outbreak. The communication problems revealed in this outbreak response trouble me greatly as to our preparedness to respond to an intentional act of contamination, tampering, or bioterrorism. This hearing will also examine the facts of this case and evaluate the success of the agencies and regulators based on what the facts support. It seems to me that one inconvenient fact is that the investigators identified the wrong commodity in the first epidemiological case study. I realize CDC and FDA may take the official position that tomatoes have not been ruled out as a potential source of contamination, but the facts remain that not one contaminated tomato has been identified out of the 1,400 samples taken. On July 21st, a positive sample of the outbreak strain of Saint Paul salmonella was found on a jalapeno pepper and yesterday afternoon, FDA investigators found the same salmonella strain on a Serrano pepper in Mexico and in a nearby water reservoir. How can we measure the performance of a trace-back system in which the original commodity identified may not have been the source of contamination? How do we judge the success of a trace-back and consider the case solved and closed? One last point about FDA--I would note that at the same time we are having this latest food safety hearing, my staff is continuing to have discussions with Chairmen Dingell, Pallone, and Stupak's staffs about food and drug safety improvement legislation, including the issue of mandatory recall authority for FDA. Given FDA's performance in this instance, and how devastating this has been for our nation's tomato producers, I shudder to think how much more financially devastating it would have been had FDA been given mandatory recall authority. Tomatoes may have been recalled earlier; producers would have lost more money; and people would continued to have gotten sick from tainted peppers. And I think that we need to consider exactly how effective mandatory recall authority would be if it is given to an agency that seems to have a lot of logistical problems communicating with state and local public health officials. Thank you Mr. Chairman. I look forward to hearing from our witnesses and thank them in advance for being here today. Mr. Stupak. Thank you. And I know members will be in and out; there is another hearing going on. So we look forward to your submission and we will put it in the record at the appropriate time. Mr. Burgess next for opening statement please. OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Burgess. Thanks, Mr. Chairman. And I guess I did not realize this was the ninth hearing but I appreciate the Chairman of the full committee bringing that to our attention because I do think it is instructive. I want to thank the panelists for being here with us today. Many have been here with us before and some are new to the process but we welcome you all here to the committee and we are anxious to hear your testimony. This issue, suffice it to say, has been at the forefront of our nation's consciousness the past few months. And we know that it is impossible to reduce food, there is an irreducible minimum beyond which you cannot go with food-borne illness, but still it is our obligation and it is the FDA's obligation as the premier federal agency to ensure that the products that come to our nation's tables are indeed safe so people can feel safe and secure in the purchases that they make. Now, the Food and Drug Administration has been diligently trying to do the trace-back. And we will hear a lot about trace-back and how perhaps there are some ways that this can be streamlined and improved. And I am anxious to hear from the individuals at the Department of Health in Minnesota because it seems like they got to the root of the problem much more quickly. In the meantime, of course, our distributors, our retailers, our restaurants have suffered many, many millions of dollars in loss as a result of the public health risk. But the fundamental issue here is that the Food and Drug Administration is in desperate need of help. And this committee, this is the committee that should be helping beyond just holding nine hearings. And we do it over and over again, hearing after hearing. And when, Mr. Chairman, are we going to take some action. And we sit here, we have all the levers of government ahead of us, in front of us that we can pull and all the powers of Congress and the only thing we have managed to do so far is hammer the FDA. And while that may make for good sound bites and that may make for good television on cable, it is not good enough for the American people. As the consequence, the image of the FDA has suffered and I would submit that the image of the United States Congress has suffered as well, and that is something that I think we must stop. We do need to give the FDA more resources. We need to give the FDA more personnel. We all get that. There has been a small attention, a small amount of attention paid to that as a supplemental. But it is not good enough just to put a bunch of funds down the pipeline and then think we have done our job, there has to be the steady state, there has to be the ongoing appropriations process needs to behave as it is supposed to behave not in this stop and start fashion that we have done the past 18 months. The FDA needs to know that they have a steady supply of funds on which they can depend. And we have not been able to manage even that simple task. Probably almost 18 months ago we had one of these food safety hearings, and I do not even remember then what we were investigating, but as a consequence of that investigation I see Mr. Hubbard here again and I welcome him back to the committee, he has been very helpful in working with our office in trying to craft legislation that will just simply allow us to stop a problem when we encounter a problem. H.R. 3967 was developed as a consequence of one of the hearings we had in this committee, the Imported Food Safety Improvement Act, and as yet we have had no legislative hearing on that or any other measurable improvement. The fact remains that after the FDA did their work, after they finally found the problem it is Friday. And on the Lou Dobb's Show when the commentator asked the reporter, well, what is the FDA recommending that consumers do to protect themselves? Well, ask, ask where the peppers were bought? We did not have even the ability to say no more imported peppers for at least this weekend until we figure out this problem. We have to have the ability once we identify where the problem is we have to have the ability to put an immediate stop so the American people will have at least some confidence that, yes, they may still need to ask where this pepper came from if it came into last week but no new sources of contamination are going to come across our borders until we have figured out the problem. So I am glad we are here today. I am glad we are having a hearing. I wish we would do something concrete. And let us do focus our energies on providing Food and Drug Administration the resources and the authority and the improved processes that it needs to protect our food supply. So I will continue to work to draft legislation to improve the Food and Drug Administration's ability to stop products from entering the American marketplace. If this committee ever actually gets around to legislating on the issue I would appreciate the opportunity to work with the Chairman so that the fact that one of every four Americans is almost daily touched by the Food and Drug Administration's activities that they can feel safe and secure the Food and Drug Administration has the cops on the beat for them. And I will yield back. Mr. Stupak. Thank you. I thank the gentleman and as the gentleman pointed out, it is the ninth hearing and for the ninth time we do have Mr. Dingell's global drug and food safety act which is being negotiated with all the parties including many of the people in this room and with the minority side. Mr. Burgess. If the gentleman would yield. Mr. Stupak. Sure. Mr. Burgess. My staff and I stand ready to participate in those negotiations but as yet we have not been asked. And I would greatly appreciate the Chairman offering my office the courtesy of participating in that activity. And I will yield back. Mr. Stupak. Sure. We have been working with Mr. Barton and the Republican side and we hope to have a bill up as soon as we get back. In fact most of the food provisions have been pretty much negotiated. So it's been an inclusive process, both Democrats and Republicans have been doing it, and they are bringing it up every hearing. And I just wanted to remind you for the ninth time we have been working on it and we will have a bill. And with that it is Mr. Murphy's turn for an opening statement please, sir. OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA Mr. Murphy. Thank you, Mr. Chairman. I appreciate these hearings and also look forward to continuing to work with you on these food safety issues. You know, oftentimes when we are concerned about something the size of a food outbreak the call is for more government. Of course, government has its own problems as well whenever we are working on any issue, we need a system that can constantly learn from itself and adapt from its errors in reviewing problems. And we are immersed in that situation right now. Families across America want fresh, safe, affordable food year-round. And that is a formidable task. The FDA is tasked with inspecting and ensuring the safety of products, and protecting our citizens from food-borne illnesses and dangerous chemical alterations and acts of terrorism. The number one goal is to prevent this contaminated food from getting to the table. But unfortunately a lot of problems get through. Some 76 million people contract food-borne illnesses, 325,000 get hospitalized, and 5,000 die. Four hundred to 500 food-borne illness outbreaks are investigated each year by state and local officials. Let's keep in mind a lot of those food-borne illnesses have nothing to do with the food handling industry, many of those are what happens once it's in the consumer's home not properly handled, refrigerated or cleaned. And to the add to the formidability of this task, some $2 trillion in imports each year, 60 percent of that is food. Eighty percent of our seafood is imported and 40 percent of that comes from China. Many of those have been found with some chemical alterations. And we have had other hearings on some things that are downright poisonous added. We have passed some bills to help traceability but we need to have Congress and the food industry be able to review these records quickly. I am pleased to hear that some of the private groups are working with the FDA to do that. But the FDA needs to be sufficiently staffed and funded to do this. We have appropriated funding for this purpose. GAO concluded that the FDA did not reveal any planned process yet by which this plan will be implemented, and we want to see that. Consumers need to be responsible for their actions. The FDA needs to follow through on the proper epidemiological evidence. And I am hoping that one of the things we can review today is just what happened. My understanding is one of the things that occurred is people who contracted illnesses were interviewed but those who ate the same food were not interviewed. If that is the case, it is a serious epidemiological research issue which we may need to review. I would like to find out if that is the truth. We also need to find ways to make whole the farmers and those in the food industry who were damaged by this scientific error. And I put ``scientific'' in quotes. But also let us keep this in mind: our food industry here is among the safest, if not the safest in the world. And what has happened with public health efforts have improved the lifespan of Americans. You know, earlier in the 19th Century when the average person lived to be 40 or so and by the end of the 20th Century living up into the 70's was basically because of public health issues, primarily with clean water and sanitation and some food issues. We need to continue with our history of success in this. But this just shows what happens when you import so much food from around the world that we cannot possibly have an inspector standing at every plant and watching every vegetable and fruit come across the border ever moment of the way. Now I believe only 1 percent of foods are inspected. We also need better communication with the public when these things get out. I saw signs appearing everywhere when the concern was about tomatoes but, unfortunately, when the things came out about jalapeno peppers I was surprised in a bittersweet way to see the warnings were saying such things as do not feed contaminated food to infants. I cannot imagine many parents of a wise interest who are actually deciding whether or not to feed jalapeno peppers to their infants. I guess they think that spices up the applesauce or something. But the issues, however, are formidable and ones we have to properly address here. And I want to say this, I certainly believe that the people in the FDA want to do this in the right way. I also believe there are people in the food industry who want to do this in the right way. There are a lot of intelligent people in this who want to fix this system. And my hope is that whatever bill we come out with is a way of opening up a door so we have a system where people with real expertise who are motivated to fix this, because I do not believe anybody wants to hurt consumers. There are no farmers out there that want to see anybody sick. There are no food processors or companies that want to see their own children or grandparents ill from these foods. We are Americans caring about Americans and we are going to fix this problem. And I want to make sure that we have a bill shaped by the intelligent statements coming from people on these panels today that will make sure we have a good, open process that can learn and evolve as we go on. And with that I yield back, Mr. Chairman. Mr. Stupak. Thank you, Mr. Murphy. That concludes the opening statements. We will have our first panel which is a panel of growers and producers. On my far left is the Honorable Charles H. Bronson who was Commissioner of Agriculture at Florida's Department of Agriculture and Consumer Services; the Honorable A. G. Kawamura, who is the Secretary of California's Department of Food and Agriculture; Mr. Reginald Brown, who is the Executive Vice President of Florida Tomato Growers Exchange; Mr. Ed Beckman, who is President of the California Tomato Farmers; Mr. Parker Booth, who is the President of Ace Tomato Company in California; Mr. Thomas E. Stenzel, who is President and Chief Executive Officer of United Fresh Produce Association; and Mr. William Hubbard, who is a Senior Advisor to the Coalition for a Stronger FDA. Welcome all of our witnesses. It is the policy of this subcommittee to take all testimony under oath. Please be advised that you have the right to be represented by counsel or advised by counsel during your testimony. Do any of you wish to be represented by counsel during your testimony? [No response.] Mr. Stupak. Everyone is shaking their heads no, so I will take it as a no. Therefore, let me ask you to please rise and raise your right hand to take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect that the witnesses replied in the affirmative. Each of you are now under oath. We will now hear a 5-minute opening statement from our witnesses. You may submit a longer statement for inclusion in the hearing record. Mr. Bronson, can we start with you, please, sir. Pull that mike up a little bit, turn on that button there, you should get a green light. And you are on for 5. Thank you. STATEMENT OF CHARLES H. BRONSON, COMMISSIONER OF AGRICULTURE, DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES, STATE OF FLORIDA Mr. Bronson. Thank you, Mr. Chairman, Ranking Member and members of the committee, for allowing us to come today to talk about this issue of the FDA, CDC, and the States working on this issue of trying to get to the bottom of potential contamination of the food supply. I am the elected Commissioner of Agriculture for the State of Florida. Food safety is part of my main function for the people of the State of Florida to protect the people against plant and animal pests and disease from causing any type of problem in the State of Florida. We have 3,700 employees. We are the largest Department of Agriculture, State Department of Agriculture in the country because I do also have law enforcement and forestry firefighters underneath my office as well as laboratories for food safety and approximately 158 personnel that are food safety specialists with the State of Florida and 50 lab personnel. And we are part of the FERN program with FDA and CDC to test for their particular issues. I think that I would indicate to you that thanks to the cooperation of the tomato industry and the University of Florida's Institute of Food and Agricultural Science at the University of Florida's land grant college we put together a program specifically on tomatoes at the request of the industry 3 years ago. And we have the toughest inspection/verification program in the nation for tomatoes. That was a voluntary program the past year-and-a-half. We put into rule July 1 all of those provisions that we had been working under. We made FDA aware of that. And that is why I consistently said over and over that I was 99.99 percent sure that Florida-grown tomatoes was not a part of this problem. As we now find out that not only was Florida-grown but there are no tomatoes that have been shown so far to have Salmonella Saintpaul. I think if I could get anything out of this meeting today I sit on an advisory group for the National Association of State Departments of Agriculture, one of two members sitting on that group who is working on issues with USDA and Customs/Border Patrol specifically on plant and animal pests and disease brought into our states from offshore which is where I would like this committee to consider is where this all begins, not necessarily with FDA and CDC. However, it starts with USDA inspection, Customs/Border Patrol come into our states and then filtrates throughout the United States. My point to you would be today that we have 158 inspectors that are just as qualified as any federal inspector out there today. We have lab technicians that are just as qualified with Ph.D.s, our medical teams with our public health are bona fide medical doctors, just as you will find anywhere in the country. We work very closely between our food safety laboratory, our Department of Agriculture inspection teams, and our local health departments and state health department on potential food-borne illnesses. We also have protracted outbreaks of Avian Influenza and gone through the whole process of how we will handle that, how we will work with the different federal, local, and other State agencies. And I would hope that if we get anything out of this meeting that we can work some type of MOU out since we are using the same process that the federal agencies use, including trace-back and trace-forward, that the use of the personnel that I can call within a moment's notice and put then on the road in the area where the problem may be, not is, but may be. So that we can take inspections of the field, we can take inspections of the produce, we can take inspections of the animals if this happens to be an animal situation, and we can send it to our FERN-approved laboratory that works with the federal government and we can start on it immediately. We do not have to wait for a group at any level of the federal government to decide when we are going to do it, how many people we are going to send, how we are going to react to it. I can do it by a phone call. On 9/11 at the incident of 9/11 we were sitting in our office or we actually were having a cabinet meeting in the State of Florida, we pulled all of our agricultural leadership together for the State of Florida's department. We were not only taking pictures of people driving hazardous materials at our interdiction stations, which I have 23 of them that we operate in the State of Florida, but we sent our food inspectors out to the grocery stores to make sure no one was tampering with the food supply on the shelf on the day of 9/11. So we have the capabilities of doing these programs in concert with the federal FDA and CDC. We do not want to take over their jobs, what we want to do is do an MOU that says if you do not have the personnel available let us use our people to go get this done immediately so we can clear the State of Florida if that is the case or prove we have a problem. We do not want people in the State of Florida sick any more than any of the people in your states do. We certainly believe in protecting the public and our tourists that come to the State of Florida. And we want to get to it as quickly as possible. But I think the way this will work the best is if we can work an MOU out so that we can put these people working together on the same issues to protect the people of this country. Thank you very much. [The statement of Mr. Bronson follows:] Statement of Charles H. Bronson Summary of Key Points FDA did not share or solicit critical information from state food safety agencies. State resources could have augmented FDA's efforts if more information had been shared such as where to target our sampling and laboratory analysis. FDA also failed to ask states to provide them with information we now know they needed such as where were tomatoes being grown at the time and at what stage of harvest. This information would have allowed FDA to immediately target their efforts and potentially lessened the impact on the industry as a whole. States found themselves having to exonerate themselves by asking to be put on the ``safe list''. Florida is the only state to have adopted mandatory regulations for the production and safe handling of tomatoes. These were developed as a cooperative effort between the Florida Department of Agriculture and Consumer Services and the Florida tomato industry. FDA dismissed our industry's participation in this program as though it had no bearing on the risk Florida presented in potentially being part of the outbreak. FDA did not employ a common sense approach to assessing the source of the outbreak. Florida tomatoes were implicated as much as Mexican tomatoes by FDA in the investigation because our product happened to be in the market at the same time as Mexico's. The number of salmonella cases per state showed that the vast majority were concentrated in the West, with Florida having only three cases (a state of over 18 million people). If Florida grown tomatoes were the source, one would logically expect us to have a high number of cases. While it may have been theoretically possible for Florida to be the source, it was not plausible based upon the geographic distribution of illnesses. We do need to improve traceability on all levels, but particularly at the re-packing house level. We know that Mexican tomatoes must be labeled as such when they come into the country. Labels, bar codes or some type of additional identifier indicating where the product was grown should have to travel with the product to the final point of sale. Roles and responsibilities of each governmental agency, both state and federal, in response to food-borne illness outbreaks need to be clearly defined. Every agricultural producer in this country is familiar with the risk they take every time they put a crop in the ground and there are tools available to mitigate that risk but we never anticipate that our business will be destroyed by an action of the federal government. Testimony My name is Charlie Bronson and I am Florida's Commissioner of Agriculture. I want to express my appreciation to the Chairman and Ranking Member for holding this hearing to examine the ongoing salmonella outbreak and the government's response to it. As Florida's food safety regulator, I believe it is critical that we make whatever changes are necessary in the system to protect public health and safety, limit the financial damages that accrue on the industry that is implicated in situations like this and restore consumer confidence that our food supply is safe to eat. To give you a little bit of background on the Florida Department of Agriculture and Consumer Services (FDACS), we are the largest state department of agriculture in the country with over 3700 employees. FDACS has a broad and varied statutory mission in Florida that covers everything from food safety and forestry to consumer services and aquaculture. These are in addition, of course, to the plant and animal duties borne by most state departments of agriculture. Put another way, we have a great deal of ``boots on the ground'' that can be activated quickly and efficiently to assist federal agencies during times of crisis. Florida has quite a bit of experience working cooperatively with federal agencies, sometimes under less than ideal circumstances, notably in the aftermaths of hurricanes. I feel we are well prepared, therefore, to offer great assistance during outbreaks such as this. Unfortunately, if FDA chooses to limit the information they share with states, we are likewise limited in how useful our assistance will be to them. State and federal agencies have got to work together to protect public health and safety whether it be law enforcement officials or food safety officials. Obviously this outbreak has exposed vulnerabilities in our nation's food safety net which is widely viewed as the best in the world. It has now been over 3 + months since the first exposure occurred and FDA still does not know the source of the salmonella contamination. In fact, they are stating publicly that they may never know the source. Frankly, as an elected official charged with protecting food safety in Florida, that is an unacceptable outcome in my opinion. From the very beginning, it was clear to us that FDA was not sharing important information with state regulators. In my department, three people hold FDA commissions, myself included. These commissions should have allowed FDA to share information with us that was not publicly available. Throughout the course of this outbreak, states have not been told much more than what FDA made available to the media. In addition, we also became aware of a disconnect between the information that was being provided to state epidemiologists and state food regulators. Oftentimes, information the CDC was providing on their calls to state public health agencies was more thorough than what FDA was providing to the state food safety regulators. Since these two functions are often in two different state agencies, the information does not always flow quickly between the two. Luckily for Florida, FDACS works very closely with our public health officials and they allowed us to sit in on the CDC calls. However, this is not the case in every state and I believe it is cause for concern. It is important to note that most states have laws that protect information we receive during the course of a food-borne illness investigation. Even Florida, which has one of the broadest public record laws in the country, known as the Sunshine Law, has public records exemptions that protect this type of information. Perhaps a compromise to FDA's confidentiality concerns on information sharing is for FDA to provide more detailed information in a timely fashion to those states that perform inspections and collect samples under contract with them. This will allow us to move more rapidly and coordinate our efforts with our FDA partners to get a mission accomplished. As I stated earlier, we have many resources at our disposal that could have augmented FDA's efforts yet without information on initial results of their investigation, we didn't know how to target our efforts. FDA also failed to ask states to provide them with information we now know they needed and of course, we had no way of knowing what kind of data that was without them telling us at the time. As an example, in the initial days of the investigation, FDA could have asked states if their producers were even growing the suspect product and what stage of harvest it was in. Having this information would have allowed FDA to immediately focus their efforts and eliminate some states from further scrutiny. FDA would then have been able to target their resources more effectively. I should say that states, including mine, eventually started providing FDA with this information, but for a much different reason. Given the broad brush of the outbreak and the financial impacts associated with consumers avoiding all tomatoes, states provided this information in an effort to get on the FDA ``safe list.'' Had FDA immediately asked for this information, not only would it have helped narrow the focus of their investigation, but providing it to the public might have lessened the financial impacts to the industry as a whole. Florida was the first, and to my knowledge, is still the only state to have adopted mandatory regulations on Good Agricultural Practices (T-GAP) and Best Management Practices (T-BMP) for the production and handling of tomatoes. The T- GAP's and the T-BMP's are based upon sound scientific research and establishes practices and procedures for the safe handling of tomatoes. It was developed as a cooperative effort between the Florida Department of Agriculture and Consumer Services and the Florida tomato industry. There were many reasons for doing this, but an important consideration was the need to limit or avoid food safety issues associated with Florida's products, many of which are perishable. Like many of the perishable commodities that Florida produces, tomato growers can't simply hold on to their product until the crisis passes. Following FDA's announcement that tomatoes were the product suspected of being the source of the outbreak and Florida tomatoes in particular, we reminded FDA that we had this program in place. We thought that this information would allow FDA to more specifically target their resources based on risk as well as keep our growers from being caught up in the dragnet. Unfortunately, FDA dismissed our industry's participation in this program as though it had no bearing on the risk Florida presented in potentially being part of the outbreak. One of our greatest frustrations is that Florida was as implicated as Mexico from the very beginning of the investigation yet a simple review of the number of salmonella cases per state showed that the vast majority were concentrated in the West. Florida had only three cases in a state of 18 million people. Given the large amount of Florida tomatoes that are consumed in our state, if Florida grown tomatoes had been the source, one would logically expect us to have a high number of cases. Since our tomatoes were in the marketplace at the same time as Mexico it may have been theoretically possible for Florida to be the source. It was not, however, plausible that we were based upon the geographic distribution of illnesses. We have repeatedly raised this issue to FDA yet they continue to maintain that Florida could have been the source out the outbreak and Florida grown tomatoes have yet to be exonerated officially. In fact, Dr. David Acheson, FDA's Associate Commissioner for Foods told the New York Times as late as June 19th that the ``tainted tomatoes were probably grown in Mexico or central or southern Florida''. A statement like this without strong data to corroborate this allegation is tantamount to a death knell in terms of consumer confidence in an agricultural commodity. We have learned some lessons from this situation that will help us be better positioned to respond to outbreaks like this in the future. One is that we need to improve traceability on all levels, but particularly at the re-packing house level. Companies, which may have their business operations based in Florida yet grow in both Florida and Mexico, often label their boxes and their invoices with their Florida business address. This resulted in FDA finding invoices in their traceback that indicated a product was from Florida but in fact came from Mexico. We know that Mexican tomatoes must be labeled as such when they come into the country. Labels, bar codes or some type of additional identifier indicating where the product was grown should have to travel with the product to the final point of sale. We also need to clearly establish the roles and responsibilities of each governmental agency, both state and federal, in response to food-borne illness outbreaks. This could be accomplished through a Memorandum of Understanding (MOU) between the FDA, CDC, state public health agencies and state departments of agriculture. This MOU should outline the expectations and actions that should be taken to timely gather evidence in an investigation. I would also like to highlight legislation introduced by a member of Florida's Congressional Delegation, Representative Adam Putnam, that would help strengthen the safeguards on our nation's food supply. H.R. 5904, The Safe Food Enforcement, Assessment, Standards and Targeting Act or ``Safe FEAST Act'', co-sponsored by Representative Jim Costa of California, would put in place new food safety standards throughout the food chain. To ensure the highest level of food safety to American consumers, the legislation requires all domestic and foreign food companies selling food in the U.S. to conduct a food safety risk analysis that identifies potential sources of contamination, outlines appropriate food safety controls, and requires verification that the food safety controls implemented are adequate to address the risks of food-borne contamination. In addition, to ensure that food products coming into the United States from international sources are safe, imported goods would have to adhere to the same safety and quality standards as set by the FDA. This would be accomplished by their completion of a Foreign Suppliers Quality Assurance Program as well as documenting their food safety measures and controls for FDA review. I would respectfully urge you to adopt this legislation. The losses that have been sustained by this industry are still being calculated. You will hear from Reggie Brown with the Florida Tomato Exchange shortly and he will be able to talk more specifically to those losses. Millions of dollars lost and yet there is still not one shred of evidence suggesting that Florida grown tomatoes were the source of this outbreak. They were implicated simply because they happened to be in the market at the same time as Mexican tomatoes. There has got to be a way to protect public health while minimizing collateral damage to an industry. Mr. Chairman, as a 6th generation farmer and rancher, I know every time a growers puts something into the ground we take a risk that it may be destroyed by a weather-related event such as a hurricane or a drought. Pest and diseases can also wreck havoc on a crop, a fact that Florida growers know all too well. But I can tell you we never anticipate that our business will be destroyed by an action of the federal government. As Florida's Commissioner of Agriculture, I don't know how to tell my agricultural producers to prepare for something like that and there is certainly not a crop insurance tool out there to guard against these types of losses. Again Mr. Chairman, I want to thank you for having this hearing on an issue that you can see I feel very strongly about. Florida stands ready to assist both the FDA and CDC on their efforts to improve the current system in any way we can and I would be happy to answer any questions you may have. ---------- Mr. Stupak. Thank you. Mr. Kawamura, your opening statement please. And please pull that mike up a little bit so we get to hear you clearly. Thank you. STATEMENT OF A.G. KAWAMURA, SECRETARY, DEPARTMENT OF FOOD AND AGRICULTURE, STATE OF CALIFORNIA Mr. Kawamura. Thank you, Chairman Stupak and members of the committee. It is a pleasure to be here. I appreciate this opportunity to address the committee about the food supply of the 21st Century. As the leading producer of fruits, vegetables, and nuts, and the leading producer of dairy products, milk, with a farm gate of over $32 billion, California is a diverse supplier of food and other products to this Nation, and we are a leader on food safety programs. In dealing with human health and the kind of outbreaks that we have seen, human health is always going to be paramount. We recognize that that is a priority when we are looking at any kind of an outbreak. And we know that the focus then also must entail recognizing that this food supply that we enjoy today does come with tremendous balance, tremendous abilities to deliver food, and especially perishable foods in a safe manner. The difficulty of having a quick and reliable trace-back system I think is one of the main focuses of this committee because by having a trace-back system we are able to quickly identify which products are and which products are not a part of any outbreak. And I think that is one of the focuses that we will have to get to at the end of this session today. We recognize and understand that the Centers for Disease Control and Prevention and the FDA have been working very hard with their resources to identify the sources of this recent outbreak and others in the past and will undoubtedly initiate more of a full review of their processes as we move forward. We have directed growers and processors in our State to develop and implement written and scientifically-based guidelines for food safety and food safety prevention. We must also ensure that the public health and regulatory agencies develop and implement their written and scientifically-based procedures for conducting these very complex investigations. We recognize that it is easy to look for quick fixes. And while we look for someone to blame for the current Salmonella Saintpaul outbreak we must recognize that the complexities of our modern food system are actually quite remarkable. It is a remarkable system that continues to improve with new technologies and advances through research. I would like to mention that I think after every outbreak, which we would like to prevent in the first place, but after every outbreak this system improves, the system tightens down, we are able to use the technologies of the day to modify, to improve, to eliminate those kind of threats to the food supply. And that process takes place every day. I think Mr. Barton from Texas mentioned that is this system broken or does it need a tune-up? And I would submit to you today that this system needs a tune-up basically using the 21st Century tools that we have today. And my colleague Mr. Bronson mentioned again the many resources and tools that we can converge to deal with food safety in our nation. We also recognize that in our State of California good ag practices has been a hallmark of what we continue to provide for this country, whether it was dealing with pistachios years ago, with the challenges of fungus disease that is found with them, whether it is the almond industry and the adopted federal regulations that they put into place requiring raw almonds to undergo an approved pasteurization process. The California tomato industry as well in our State has developed tomato- specific best practices to ensure that their tomatoes are produced under safe guidelines. These programs also require USDA-trained inspectors to conduct random and continuous audits to ensure compliance with these programs. We recognize that the leafy green marketing agreement which brought together not only spinach but all the different vegetable products that are of the leafy green nature. This was accomplished last year and has completed a successful year of voluntary compliance and audits that involve not only the Departments of Agriculture here and at USDA but FDA, Departments of Public Health and the industry in dealing with solutions using the technologies of today to get to the bottom of these causes of food-borne illnesses. In closing I would like to mention that we have many next steps that we need to deal with. And let me go through those now. We must balance then the ability to make sure and ensure public health and a public warning system when we do have an outbreak with also the very important desire to make sure that our producers that are not implicated in an outbreak are not damaged. We encourage a better dialogue then between the FDA, States, growers, handlers and retailers to identify good ag practices at all levels of the food chain. Prior to making a food-borne illness announcement FDA should solicit states to provide commodity harvest data. This can minimize the guesswork and can limit the number of growers implicated in any outbreak. Growers, shippers, and distributors and retailers must agree on a standardized, uniform set of criteria that will follow a product from farm to point of service, enabling quick and accurate identification of the routes and sources of all products and all produce. We encourage more research dollars be spent on identifying the life cycle of food-borne illnesses, potential points of entry and kill-step technology to ensure safe products. In our state we work closely with the Western Institute for Food Safety and Security as well as the newly established Center for Produce Safety at U.C. Davis to improve methods of growing and safe handling of food products. Better surveillance of imported products is critical. Consumers are relying more and more on a year-round supply of products that come from outside the United States. Programs must be established to do a better job of monitoring and testing food product imports. By monitoring our points of entry for repeat violators of false import declarations, making changes in import volumes at points of entry, and random sampling of products for contaminants we can more effectively identify sources of potential risk. We also then urge Congress to support States in the development of programs that result in the implementation and auditing of Good Agricultural Practice. And lastly, there must be funding to implement a uniform system for epidemiological reporting and investigating outbreaks in all states. And with that I will submit the rest of my testimony for the record and look forward to continuing with this conversation today. [The statement of Mr. Kawamura follows:] Statement of A.G. Kawamura Summary of Major Points We must balance warning the public while minimizing the impact to growers.
1AWe encourage a better dialogue between FDA, states, growers, handlers and retailers to identify Good Agricultural Practices at all levels of the food chain. 1APrior to making a food borne illness announcement FDA should solicit states to provide commodity harvest data. This can minimize the guesswork and can limit the number of growers implicated in an outbreak. 1AGrowers, shippers, distributors and retailers must agree on a standardized, uniform set of criteria that will follow a product from farm to the point of service, enabling quick and accurate identification of the routes and sources of all produce. 1AWe encourage more research dollars be spent on identifying the life-cycle of food borne illnesses, potential points of entry and kill-step technology to ensure safe products. We work closely with the Western Institute for Food Safety and Security as well as the newly established Center for Produce Safety at University of California at Davis to improve methods of growing and safe handling of food products. 1ABetter surveillance of imported products. Consumers are relying more and more on a year-round supply of products that come from outside the United States. Programs must be established to do a better job of monitoring and testing food product imports. By monitoring our points of entry for repeat violators of false import declarations, making changes in import volumes at points of entry, and random sampling of products for contaminants, we can more effectively identify sources of potential risk. 1AWe urge Congress to support states in the development of programs that result in the implementation and auditing of Good Agricultural Practices. 1AThere must be funding to implement a uniformed system for epidemiology reporting and investigating outbreaks in all states. Statement Good morning Chairman Stupak, and esteemed members of the committee. I appreciate the opportunity to address this committee and also I would like to thank Congress for its support of 21st Century agriculture in the 2008 farm bill. As the leading producer of fruits, vegetables and nuts, and the top producer of milk, with a farm gate of $31.4 billion, California is a diverse supplier of food for the nation and a leader on food safety programs. Human health is paramount in any foodborne illness outbreak. Outbreak investigations are complex and resource intensive, particularly those involving perishable foods such as fresh produce. By the time the surveillance system recognizes clusters of illnesses, 2-3 weeks have passed from the initial exposure. In this timeframe, entire fields or growing areas have been replanted and no samples remain. Epidemiological investigations rely on consumers to remember the foods they ate days or weeks ago and thus include some degree of uncertainty. Trace back investigations depend upon firms providing accurate and complete records in a uniform format to investigators and may involve detailed assessments of dozens of firms and fields. Agencies must have adequate resources and laboratory surge capacity to conduct these investigations in order to quickly, accurately, and narrowly pinpoint the source of an outbreak. We recognize and understand that the Centers for Disease Control and Prevention and the Food and Drug Administration have been working very hard with the resources they have to identify the source of the most recent outbreak and will undoubtedly initiate a full review of existing epidemiologic and regulatory approaches to implement needed changes. As we have directed growers and processors to develop and implement written, scientifically based guidelines, we must also ensure that public health and regulatory agencies develop and implement written, scientifically based procedures for conducting these complex investigations. Unfortunately, a false implication has an impact on the state's commodities and the ability for farmers to sell and market their products. In 1996, an epidemiologic investigation of cyclospora illnesses incorrectly identified California strawberries as the likely source of contamination. Subsequent investigations revealed that the actual source was Guatemalan raspberries. Initial epidemiologic information in the most recent salmonella investigation implicated tomatoes, possibly from California. However, subsequent investigations appear to point to imported peppers. To be a farmer means to take risks due to weather, pests, market fluctuations, and other influences. Yet there is nothing more devastating to a farmer than to dump a perfectly good crop due to suspicion of contamination. However, public health agencies and regulators may occasionally have to take actions to protect the public without incontrovertible evidence. Without clear communication, the message to consumers is often misunderstood and the reaction is swift in the marketplace. Retailers, in order to reduce their risk of liability, act to pull products off the shelves despite general advisories that a product is declared ``safe'' to eat. The economic domino effect is felt all the way down the food chain from the farmers, to the workers, to their families and to the communities. For all tomato and jalapeno growers in the country, the promise of a successful marketing season is lost for the summer. The consumer who is rightly concerned about the safety of food products has lost confidence in tomatoes in this incident, even if the outbreak was not associated with our state, or any other. Economic Impact of Association of Salmonella with Tomatoes The impact to California tomato growers directly and indirectly is significant. According to one commodity group, our tomato growers suffered a 40 to 50 percent drop in retail sales, or $300,000 in a direct loss due to the dumping of good product, a loss of $1 million in product sales right after the announcement, and an estimated nearly $20-24 million in indirect losses due to low demand and poor prices. While it is easy to look for quick fixes and someone to blame for the current Salmonella Saint Paul outbreak we must recognize the complexities of our modern food systems. It is a remarkable system that continues to improve with new technologies and advances through research. However, the lack of adequate personnel and resources of regulatory agencies charged with protecting public health and our food supply are challenges and weaknesses we must address. There must be funding to implement a uniformed system for epidemiology reporting and investigating outbreaks in all states. Right now, we are relying on what state and local resources are available for gathering data and investigating outbreaks. Agricultural Food Safety ProgramsCalifornia has implemented various food safety programs that have been innovative and successful. The California Leafy Green Marketing Agreement is an example of how federal and state agencies, can work together with industry to create a program that uniformly applies best management practices that are designed to improve safety and quality to handlers throughout the state. Jointly developed by industry, CDFA, USDA and with input from California Department of Public Health and the FDA, the Leafy Green Marketing Agreement was created in 2007 as a response to multiple outbreaks of E. coli O157:H7 illnesses over several years. The leafy greens industry led the effort to craft Good Agricultural Practices and a mechanism for verifying practices through mandatory government audits under the authority of the Agreement. While membership in the marketing agreement is voluntary, nearly 100 percent of California's leafy green handlers are participants. Once a signatory to the program, compliance with the commodity specific program is mandatory, and violators are subject to discipline. The strength of the Leafy Green Marketing Agreement program is the mandatory government inspection program that certifies member companies are complying with the food safety Good Agricultural Practices. These standards were developed by industry, academia and regulators, and reviewed by state and federal government health agencies. Random inspections are conducted by the California Department of Food and Agriculture inspectors who are trained and certified by the USDA. Operators are required to take corrective action on all findings within an audit and follow up audits are required to verify compliance. Handlers that fail to meet the conditions of the program can lose their certification, therefore losing their ability to sell in the marketplace. A service mark assures buyers of California leafy greens that the product bearing the mark has been grown according to the food safety practices accepted by the LGMA. These Good Agricultural Practices are being mirrored in other commodities. The almond industry adopted federal regulations requiring raw almonds to undergo an approved pasteurization process, or be labeled as ``Un-Pasteurized''. The California tomato industry has developed tomato specific best practices. These programs also require USDA trained inspectors to conduct random and continuous audits to ensure compliance with these programs. The California Set Labeling Requirements for Tomato Industry California has also implemented tomato-labeling requirements that are unique to handlers in the state. Existing California Food and Agriculture Code provides the authority to require certain labeling and quality standards. All shipping containers of fruits, nuts and vegetables are required to have basic labeling including: Identity (the commodity); Responsibility (name and address of handler or packer or shipper); and Quantity (weight or volume). In addition to the existing labeling standards, California tomato handlers are required to have the lot and grower ID on the container. This was established in 2006. In the event of violation of this article, a handler shall provide, upon request of the Secretary or his representative, records related to field location, grower, harvest date, pack date, transporter, and purchaser of packed tomatoes. These records shall be maintained for the current marketing year. This identification provides a better mechanism for traceability of a product in the marketplace. The produce industry is focusing significant attention on the improved traceability of produce. Industry associations have voiced concerns about the inability to track produce in a standardized, electronic format from farm to point of service. Industry groups have been meeting for several months to develop new standards for traceability from farm to table. Growers, shippers, distributors and retailers must agree on a standardized, uniform set of criteria that will follow a product from farm to the point of service, enabling quick and accurate identification of the routes and sources of all produce. Next Steps We must balance warning the public while minimizing the impact to growers. 1AWe encourage a better dialogue between FDA, states, growers, handlers and retailers to identify Good Agricultural Practices at all levels of the food chain. 1APrior to making a food borne illness announcement FDA should solicit states to provide commodity harvest data. This can minimize the guesswork and can limit the number of growers implicated in an outbreak. 1AGrowers, shippers, distributors and retailers must agree on a standardized, uniform set of criteria that will follow a product from farm to the point of service, enabling quick and accurate identification of the routes and sources of all produce. 1AWe encourage more research dollars be spent on identifying the life-cycle of food borne illnesses, potential points of entry and kill-step technology to ensure safe products. We work closely with the Western Institute for Food Safety and Security as well as the newly established Center for Produce Safety at University of California at Davis to improve methods of growing and safe handling of food products. 1ABetter surveillance of imported products. Consumers are relying more and more on a year-round supply of products that come from outside the United States. Programs must be established to do a better job of monitoring and testing food product imports. By monitoring our points of entry for repeat violators of false import declarations, making changes in import volumes at points of entry, and random sampling of products for contaminants, we can more effectively identify sources of potential risk. 1AWe urge Congress to support states in the development of programs that result in the implementation and auditing of Good Agricultural Practices. 1AThere must be funding to implement a uniformed system for epidemiology reporting and investigating outbreaks in all states. What we learn from this hearing can set the stage for improved collaboration between the state and federal agencies and farming community. Thank you for inviting me to speak with you today and thank you for your support. ---------- Mr. Stupak. Thank you. Mr. Brown, you might want to use that mike right there. We have a large panel. We usually do not have that many people on the panel but there is such great interest from the growers and producers and the commissioners we wanted to give everyone an opportunity. So, Mr. Brown, if you would start your 5-minute opening please, sir. STATEMENT OF REGINALD L. BROWN, EXECUTIVE VICE PRESIDENT, FLORIDA TOMATO GROWERS EXCHANGE Mr. Brown. Thank you, Mr. Chairman, members of the committee. The producers of tomatoes in Florida represent the largest single State fresh tomato production system in the country. We dominate the supply of fresh tomatoes in the United States from May to November. We have in fact been the primary injured parties in this entire process and we look forward to Congress addressing that concern and our injuries at some point in the future. We have a few recommendations we would like to pass on to the Committee and to the Congress. First of all, it is critical to the entire tomato industry that FDA exercise its authority to establish mandatory guidance based on the ``Commodity Specific Guidelines for the Tomato Supply Chain.'' This document was created by the industry in conjunction with science and with FDA. And we would offer that up as a program that could be implemented immediately by the FDA in a mandatory way as a guidance document for tomato production throughout the country and throughout North America. We also call for the initiation of regulations for mandatory food safety programs for tomatoes throughout the country. This is important that we do not establish a single program that forces programs on various segments of the industries are inappropriate because one size of a regulatory program will not fit all. But we encourage FDA to move forward. And we would encourage the Congress to move forward on bills such as H.R. 5904 to provide basis for those regulations going forward. We would encourage that the FDA through consulting committees or some other structure create a mechanism for the industry and other representatives to be involved in these outbreaks. These consultants could be integrated early in the outbreak and we can avoid many of the complications and problems that I think we encountered in this unfortunate circumstance. These consulting groups could be constructed to where conflicts of interest and confidentiality could be maintained. And we also have the overriding common interest of the industry and public in making sure that we get this thing right. We would encourage FDA to expand their current tomato initiative program that they have operated for the last year- and-a-half in both Virginia and Florida. We think those kinds of initiatives are important in giving the experiences and understanding and knowledge to the agency. It would assist in their understanding the industry. And we would encourage them to incorporate in those tomato initiatives trace-back exercises for small, medium, and large type growers and packers and repackers so they have a very functional understanding of our industry. We would encourage the FDA and CDC to develop the improved risk communication tools for the future outbreaks that would increase the understanding of the actual risk probability in suspected items and the risks posed to the public. Good risk analysis, informed assumptions and recommendations would facilitate greater understanding for all concerned. Such improved communications would improve public health rather than promote public hysteria. We strongly urge the formation of a blue ribbon group of experts both inside and outside government to conduct an interview or a review of the handling of the 2008 Salmonella outbreak by state and federal agencies. The purpose of this review would be to improve the effectiveness in handling future outbreaks. Learning from mistakes made is the only way to make the world a better place as a result of our unfortunate experience. We share the same interest in producing the safest tomatoes possible for consumers. It is a trust that we take extremely seriously in the tomato industry and we look forward to continuing to be leaders in the food safety arena for the American consumer. Thank you for the opportunity to be here this morning. And I will submit the rest of my testimony for the record in writing. Thank you. [The statement of Mr. Brown follows:] Statement of Reginald L. Brown Summary At the time of the salmonella outbreak in April 2008, Florida was the only state in the country growing tomatoes. In early June 2008, the FDA indicated there was a connection between the salmonella outbreak and tomatoes from Florida. It is difficult to challenge the Center for Disease Control's (CDC) and the Food and Drug Administration's (FDA) decision in associating some tomatoes with the outbreak because we are not privy to the information they had before them. FDA failed its principal task of finding the source of the salmonella and failed to promptly release those areas which were ``cleared'' by FDA's own testing or by the fact that tomatoes from these areas were not in the marketplace. As a result, the Florida tomato industry has suffered tremendously. Everyone associated with Florida's tomato industry, all the workers, farmers and packers in the designated areas and outside those areas have been harmed. We estimate the loss to the growers and packers to be $100 million, and they will continue to lose sales due the decline in consumer confidence caused by FDA. The Florida tomato industry has taken the lead position in food safety for fresh tomatoes. Tomatoes from Florida are the only tomatoes in the U.S. subject to government-administered, mandatory food safety regulations. Further, these regulations were established at the request of the industry with the specific purpose of reducing food safety risks and the probability of such an outbreak. Recommendations 1. Congress should provide relief to growers, packers, and repackers in Florida and throughout the U.S. for real losses suffered to date and those they continue to suffer through no fault of their own. 2. It is critical to the entire tomato industry that the FDA exercises its authority to establish mandatory guidance based on ``Commodity Specific Guidelines for the Tomato Supply Chain.'' We also call on the agency to develop a mandatory food safety requirement for fresh tomatoes throughout the supply chain. 3. We strongly encourage FDA to create consulting committees made up of industry representatives and others. These consultants could then be integrated into outbreak management teams in the event of an outbreak so that experiences such as those suffered in the 2008 salmonella Saintpaul outbreak could be minimized. 4. We encourage FDA to continue to expand their current Tomato Initiative to all points in the tomato supply chain. 5. The development of improved risk communication tools for future outbreaks would greatly increase the understanding of the actual risk probability in ``suspected'' items and the risk posed to the public. 6. We strongly urge the formation of a ``Blue Ribbon'' group of experts from both inside and outside the government to conduct a review of the handling of the 2008 salmonella outbreak by state and federal agencies. Statement Introduction My name is Reggie Brown. I am the Executive Vice president of the Florida Tomato Exchange (the Exchange). We generally harvest from November through May. Almost half of all the fresh tomatoes consumed in the United States year-round come from Florida. During the winter months from October to about the end of May substantially all of the domestically produced fresh tomatoes in the marketplace come from Florida. Tomato growers have seen major challenges in recent years from hurricanes, invasive pests and diseases, to increased international competition from Mexico and Canada. The fruit and vegetable industry is a critically important sector of Florida agriculture, which is second only to tourism in importance to the state's economy. According to a 2006 University of Florida study, agriculture, food manufacturing, and natural resource industries in Florida directly create more than 400,000 full- time and part-time jobs, with a total employment impact of more than 700,000 full-time and part-time jobs. The direct value- added contribution is estimated at $20.32 billion, with a total impact of $41.99 billion. Florida tomatoes are the largest vegetable crop in the state, with a value of over a half- billion dollars annually. During the winter, Florida competes in the U.S. marketplace with Mexico and Canada. During the six-to-seven-month harvesting season, Florida's tomato growers employ more than 30,000 tomato workers. Background At the time of the outbreak of salmonella in April 2008, Florida was the only state in the country growing tomatoes. In early June 2008, the FDA indicated there was a connection between the salmonella outbreak and tomatoes from Florida. It is difficult to challenge the Center for Disease Control's (CDC) and the Food and Drug Administration's (FDA) decision in associating some tomatoes with the outbreak because we are not privy to the information they had before them. However, we do think that decision was highly questionable and that once it was made, FDA failed to take appropriate actions in associating salmonella with tomatoes from a source other than from Florida. In summary, FDA failed its principal task of finding the source of the salmonella and failed to promptly release those areas which were ``cleared'' by FDA's own testing or by the fact that tomatoes from these areas were not in the marketplace. As a result, the Florida tomato industry has suffered tremendously. Everyone associated with Florida's tomato industry, all the workers, farmers and packers in the designated areas and outside those areas have been harmed. We estimate the loss to the growers and packers to be $100 million, and they will continue to lose sales due the decline in consumer confidence, caused by FDA. More immediately, FDA `s recent ``release'' of tomatoes by removing the listing from their website placed Florida's growers in a very difficult position as to planting for next season. It is not an exaggeration to say that the availability of tomatoes from Florida may be reduced for the upcoming season as a result of FDA's actions. Our growers and shippers should be compensated for their losses. We strongly urge the FDA to develop mandatory trace-back regulations for the entire tomato industry, from the farmer's field to the last retailer, based on the mandatory rules for food safety and trace-back in Florida, the guidelines adopted by the California tomato growers, and the national guidelines for tomatoes prepared by industry leaders (described in more detail below). This course of action will provide the consuming public with additional safety and confidence and will provide the CDC and FDA with the ability to quickly trace back an outbreak involving tomatoes to the source of the contamination, thereby avoiding injury to innocent tomato growers, packers, and others in the distribution system. Other recommendations are proposed below. Florida's Tomato Growers Lead the Country in Food Safety and Trace Backs The Florida tomato industry has taken the lead position in food safety for fresh tomatoes. Tomatoes from Florida are the only tomatoes in the U.S. subject to government-administered, mandatory food safety regulations. Further, these regulations were established at the request of the industry with the specific purpose of reducing food safety risks and the probability of such an outbreak. The Florida tomato growers, along with University of Florida faculty and state regulators, developed a comprehensive food safety system for growing and packing fresh tomatoes. Details of the program can be found at www.floridatomatoes.org. This program employs the most current good agricultural practices and best management practices and includes third- party audits for packinghouses and for farms and greenhouses. It is a mandatory food safety system for all tomatoes grown in Florida and has been reviewed by the FDA. For many years, Florida's tomato growers have used a trace back system, called ``positive lot identification.'' Using this system, the first buyer of Florida tomatoes can easily obtain the name of the farm and the location of the specific lot where the purchased tomatoes were grown. We have also been proactive at the national level regarding food safety, working with our counterparts in California, Mexico, and Canada, as well as the United Fresh Produce Association and other groups. We have published the second edition of, ``Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain.'' These guidelines recommend food safety practices to minimize the microbiological hazards associated with fresh tomatoes and fresh-cut tomato products at all points of the fresh tomato supply system. Certainly, the adoption of Florida's requirements, the trace-back program employed by the California tomato farmers, and the commodity-specific guidelines mentioned above can be adopted for the entire tomato industry. We are strongly supportive of mandatory regulations modeled on these programs as proposed in HR 5904. Issues Regarding the Handling of the Salmonella Saintpaul Outbreak We believe a number of things went wrong from the beginning of this investigation, and it warrants oversight by this Committee and, we believe, by others as well. We raise the following issues and comments based on incomplete information because complete information was not provided to us by either the CDC or the FDA. While we truly believe mistakes were made, the damage has been done. We hope we can regain our market and convince our consumers that the tomatoes we grow and ship from Florida are among the most wholesome and safest in the world. The food safety system we have adopted is unprecedented in the fresh tomato industry and uses the best practices available. We raise these issues to be constructive so that next time CDC and FDA can make the right association and find the source of contamination in short order. And, there will be a next time for tomatoes and for other perishable commodities because no system is 100% risk free. Risk reduction is the realistic goal of all food safety programs. We believe the CDC and the FDA incorrectly presumed tomatoes to be associated with the salmonella outbreak. We believe the data reviewed indicated tomatoes and salsa items together were the original problem. Indications that tomatoes and salsa coming from Hispanic outlets were associated with salmonella and that the saintpaul strain of salmonella has not previously been associated with tomatoes should have been given more weight. We believe the FDA erred in indicating that the outbreak was associated with tomatoes from Florida. While it is easy to suggest that the salmonella came from Florida tomatoes since Florida was the only state in the U.S. producing tomatoes in late April, we believe additional information should have been factored into this decision. Most importantly, it appears the FDA totally ignored the locations of the first outbreaks: the Southwest U.S., New Mexico and Texas. In so doing, it ignored the most likely source of tomatoes and/or salsa: Mexico. In addition, given the cost of fuel, it was most unlikely that tomatoes consumed in New Mexico came from Florida. We believe the CDC needed to share its first questionnaire and the information that led it away from Mexico as a source. We believe the FDA erred in not finding the source of this outbreak, and we believe the FDA erred in not promptly ``releasing'' tomatoes from Florida given the fact that the test done on Florida tomatoes showed no signs of salmonella. We believe the FDA erred in not bringing experts from the industry to assist with the trace back efforts. We believe that the FDA erred in not providing and communicating standards used to determine the risks to consumers from the beginning when a warning was issued, when all tests came back negative, when other items (peppers) were added, to the end. We believe the FDA erred in not exploring the tomato distribution system in the U.S. prior to this outbreak. During this outbreak, an FDA official described the tomato distribution system as ``complex.'' FDA has had prior experience in dealing with trace backs involving tomatoes and should have developed a trace back plan prior to this outbreak as well as a procedure for industry assistance.My industry colleagues on the panel will, or have already, addressed the structure of the industry and the trace back system that exists for tomatoes. Recommendations As the group most economically harmed by the salmonella outbreak due to the CDC's and FDA's actions and/or lack of actions in associating fresh tomatoes with the outbreak and in failing to quickly find the source of the outbreak and failure to promptly remove Florida as a source of the outbreak, we have a number of recommendations for this Committee to consider. 1. Congress should provide relief to growers and packers in Florida and throughout the U.S. for real losses suffered to date and those they continue to suffer through no fault of their own. From our perspective, we are in the identical situation as growers of other commodities whose crops were destroyed by natural disasters. The difference is only that our disaster was government driven. 2. It is critical to the entire tomato industry that the FDA exercises its authority to establish mandatory guidance based on ``Commodity Specific Guidelines for the Tomato Supply Chain.'' We also call on the agency to develop a mandatory food safety requirement for fresh tomatoes throughout the supply chain. Such a program could be modeled on the Florida and California programs, allowing for slight modifications to accommodate regional conditions as they exist. A one-size-fits- all approach to food safety is inappropriate. FDA should be encouraged to continue consultations and cooperation with industry groups to accomplish this goal. Current legislative proposals such as HR 5904 call for such regulations, and we fully support them. 3. We strongly encourage the creation of consulting committees by FDA be made up of industry representatives and others. These consultants could then be integrated into outbreak management teams in the event of an outbreak so that experiences such as those suffered in the 2008 Saintpaul outbreak could be minimized. These consultant groups could be structured to avoid concerns about confidentiality and conflict of interest. Everyone has a common interest in identifying and removing the source of any outbreak as quickly as possible. 4. We encourage FDA to continue to expand their current Tomato Initiative to all points in the tomato supply chain. We also encourage FDA to expand their efforts to include trace back exercises that include small, medium, and large growers, packers, and repackers as well as any others who are part of the distribution system. Such efforts would improve the level of knowledge within the FDA and provide experiences designed to expedite future trace back efforts in the event of an outbreak. 5. The development of improved risk communication tools for future outbreaks would greatly increase the understanding of the actual risk probability in ``suspected'' items and the risk posed to the public. Good risk analysis and informed assumptions and recommendations would facilitate greater understanding for all concerned. Such improved communications would improve public health rather than promote public hysteria. 6. We strongly urge the formation of a ``Blue Ribbon'' group of experts from both inside and outside the government to conduct a review of the handling of the 2008 salmonella outbreak by state and federal agencies. The purpose of this review would be to improve their effectiveness in handling future outbreaks. Learning from mistakes made is the only way to make the world a better place as a result of our unfortunate experiences. Thank you for the opportunity to present these comments for your review. ---------- Mr. Stupak. Thank you, Mr. Brown. Mr. Beckman, your opening statement please. STATEMENT OF EDWARD BECKMAN, PRESIDENT, CALIFORNIA TOMATO FARMERS Mr. Beckman. Thank you, Mr. Chairman, members of the subcommittee. California Tomato Farmers Cooperative is the largest producer of fresh tomatoes for all of North America during the summer and fall. Our cooperative was formed in 2006 by 54 growers, large and small, who represent 80 percent of the fresh tomato production in California. And we require production based upon a higher food safety standard. As noted by the secretary, we require mandatory, random and unannounced food safety audits of all ranches, all packing houses by the California Department of Food and Agriculture. We are also the co-author of the new Commodity Specific Food Safety Guidelines for Fresh Tomatoes. And we support mandatory trace-back at all levels. Although California was never associated directly with the Salmonella Saintpaul outbreak, our members have indeed lost millions in sales in both domestic and international markets due to the broad warnings related to tomatoes. But our very real concern is that this may happen again, putting the consumer at risk, and that we may see a prolonged investigation that will further weaken trust in our food supply. FDA publicly noted the difficulty of their investigation and we cannot help but ask specifically, Where was the problem? Trace-back should be able to trace fresh tomatoes from point of service to the field in hours, not days or weeks. Trace-back of fresh tomatoes is based upon lot identification codes which travel with the product. The code is printed on all containers, included on all quality control records, production reports, and forms used in the shipping of the product; it is the foundation of traceability. As you know, we recently hosted a tour for the investigative staff of this committee demonstrating traceability of fresh tomatoes across state lines. The investigative staff directed the case study that I will detail to you today. In the slides provided to the committee we will be tracing tomatoes from a single restaurant back to the grower through five handling points. And while the tomatoes move in one direction, trace-back requires a two-way flow of information among all who handle the product: the store, the distribution center, the repacker, shipper and grower. There are six steps to this trace-back investigation. [Slide shown.] We begin with the quality assurance vice president phoning a restaurant to obtain the date code on a random carton of tomatoes. That date code is relayed to the distribution center. [Slide shown.] In step 2, the distribution center uses the date code to learn the product came in on July 7 from a repacker supplier. [Slide shown.] In step 3, the supplier is phoned, provided with a purchase order for the shipment. This is the document. Using the purchase order the supplier then determines the origin of the product in a single document. [Slide shown.] In the next step the supplier holds the critical document to maintain traceability. It is a single document that documents the purchase order for incoming product and the final lot I.D. for unfinished product. It is this one single document that determines whether not there had been any commingling of product and the source of all tomatoes used in the final product. [Slide shown.] In the final slide we look at the role of the supplier who phones the shipper and using the purchase order obtains the original lot I.D. The lot I.D. includes the complete field history and it is passed forward. The supplier, using this document, now has all records they need to pass forward to the food service chain. [The information appears at the conclusion of the hearing.] The time required for this trace-back as done for the investigative committee was 35 minutes. Why did this trace-back work? Well, the answer is the use of electronic recordkeeping that is based upon lot identification and also the Bioterrorism Act. What we did was linking one step up and one step back requirements of this act at each level of the supply chain. We believe that we must learn from this outbreak and investigation to ensure that future investigations do not take months, they should not. And we therefore recommend that Congress require an analysis of the FDA tomato investigation to include individual trace-back records to effectively determine why this investigation of tomatoes was so lengthy, that FDA's tomato initiative be expanded to include tomato repackers, wholesalers and traceability throughout the supply chain, and that FDA establish a pilot project that would establish mandatory food safety production and handling requirements based upon the just-published Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain. I would like to note this standard is already employed by our members in California and Florida. Together we represent 70 percent of the fresh tomatoes produced in the United States. By taking these already high standards national we would improve preventative measures by all who produce and handle tomatoes, including smaller farms. But we caution, food safety is not limited to the grower in the packing house, it is the responsibility that must be shared by all, including supermarkets and restaurants, if we are to truly protect the consumer. This concludes my testimony. And I will welcome any questions the committee may have. Thank you very much. [The statement of Mr. Beckman follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you, Mr. Beckman. Mr. Booth, an opening statement please, sir. STATEMENT OF PARKER BOOTH, PRESIDENT, DELTA PRE-PACK, INC. AND ACE TOMATO CO., INC. Mr. Booth. Thank you. My name is Parker Booth and I am President of Delta Pre-Pack, a repack company, and Ace Tomato Company, Inc., a grower, packer, and shipper of tomatoes. Both entities are part of the Lagorio Family of Companies based in Manteca, California. Today, while farming over 10,000 acres, 3,000 of those acres are planted with a wide variety of tomatoes. Thank you, Chairman Stupak, Ranking Member Shimkus, and members of this subcommittee for the opportunity to testify before you on the topic of traceability within the fresh tomato industry and the impact this outbreak investigation has had on our two companies. A critical component of a food safety program is having the ability to trace where the product we pack for our customer comes from all the way back to the field. Trace-back is not a passive process for any company, it must be aggressively managed every step of the way. This process requires a commitment from top to bottom within an organization with a culture of accountability, not matter what the size of the company may be. Trace-back from our customer to the field can rapidly be completed using existing software programs. As a grower and shipper and also as a repacker we are required to conduct mock recalls that test our ability to trace-back product. Trace-back is not an option, it is a requirement of doing business and it works. I want to show you an example of a box that we had with our investigator team that came out just last month. And it has on it the markings. You probably cannot see it from your seat there. But the essence is from looking from the left side as the lot number. There is a lot number 23. There is also our State, Federal I.D. code which is the number for our shed which tells us that is who packed it. And finally on the far right- hand side is the date that we actually packed the product. The lot code which is on the far left, number 23, is the essence of the trace-back. This is the number that starts everything. So when we actually harvest a field we identify and label that particular field with a lot number. And that is what goes through the whole process. This is information--there is no way you can see this--but this is documentation paperwork that actually supports that, from pallet tags to lot I.D. numbers. And this is the information that will go all the way to a distribution house, all the way to a retail store, or all the way to a national chain distribution with this information. Although Ace Tomato Company was not in production at the onset of this outbreak, Delta Pre-Pack was marketing fresh tomatoes from both Mexico and Florida. The financial consequences of the inconclusive FDA trace-back increased greatly as the Center for Disease Control expanded their warning beyond the original states into Mexico and Texas. As the warning was expanded to all 50 States our suppliers in Florida and Mexico were considered suspect, as they remained within the scope of FDA's investigation. We have full confidence in our suppliers as we apply the same standard to the product they grow as we place on our own selves. It is important to note that we work closely each year with our growing partners along with our customers calibrating our food safety standards. This means we are on site in the fields, in the packing sheds verifying protocols we have established in an effort to gain agreement between ourselves and our customers that the supply chain is as safe as possible. But that confidence was not sufficient to retain our customers. Due to blanket warnings by the FDA that Mexico and Florida were not safe our customers were forced to require that we source from other states outside of our normal supply chain. In effect, we moved away from the supply chain that both our customers and ourselves had worked hard to ensure was as safe as possible. In effect, money, the money and resources we invested in our food safety efforts went for naught. Consequently, in the first week alone we had to dispose of several hundred thousand dollars worth of perfectly good tomatoes, with the total impact from the 2-month outbreak still being tallied. As a grower, shipper, and repacker of fresh tomatoes, we urge that Congress address the economic significance to all levels of the tomato supply chain that broad-based warnings may have unfairly associated safe tomatoes with food-borne illness. Consideration needs to be given to the development of a more effective warning system that would allow companies to assess their particular positions much further in advance as information from the investigations are being collected. There is a critical time early in the suspected outbreak where the industry can provide supplemental guidance to the government investigative efforts in order to obtain quicker answers. This industry support could be from a panel of industry advisors whose purpose would be to work closely with the FDA to gain them a better understanding of our industry's distribution system before an outbreak occurs and to provide guidance during any future investigation. As it is, we caused undue alarm to consumers of fresh tomatoes and undue financial hardship on an industry that contributes better than $1 billion in sales to the U.S. economy each year. This concludes my testimony and I welcome any questions that the Committee may have. [The statement of Mr. Booth follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Mr. Stenzel, your statement please, sir. STATEMENT OF THOMAS E. STENZEL, PRESIDENT AND CHIEF EXECUTIVE OFFICER, UNITED FRESH PRODUCE ASSOCIATION Mr. Stenzel. Good morning, Chairman Stupak, Ranking Member Shimkus, and members of the Committee. My name is Tom Stenzel. I am President and CEO of United Fresh Produce Association, a total supply chain association representing the fresh produce industry, multiple commodities from grower, packer, shipper all the way through retail and restaurant. Let me broaden my testimony a bit now from specifically the tomato industry but speak on behalf of our entire sector in fresh produce. We are totally committed to food safety and hold ourselves to rigorous standards in growing, handling, packing, and tracing our fresh foods. We strongly support federal oversight, mandatory federal oversight of commodity-specific risk-based rules. This outbreak also shows us that government and industry alike have not spent sufficient time in the investigation process after an outbreak as we are spending in prevention of those. Today I want to broaden the conversation a bit to some of the lessons I think we can learn from this investigation and hope to engage in a dialogue with the committee about some of these issues. Number one, there is no one in charge. Throughout the investigation it became clear that no one was in charge, leaving local, State and federal officials blind for leadership, various agencies pursuing different priorities, and well-meaning individuals reacting independently to events rather than part of a coordinated investigation moving forward in a logical and expeditious manner. We recommend that Congress require a command and control structure with a clear chain of command, take the guesswork out of who is in charge, drive real accountability and authority into this process. Second, we need better crisis preparedness and transparency in the process. The dispute today over the validity of early work by the states and CDC with food recall surveys in which tomatoes were indicted could have been avoided with properly vetted and peer-reviewed epidemiological tools ahead of time. Instead we find CDC rewriting questions that they asked consumers in the middle of the outbreak and not sharing that data broadly. Even when FDA tried to do the right thing by creating a cleared list of regional tomato production areas it was responding logically to the fact that many areas were not in production. But the cleared list became problematic and there was no easy way to explain how to get on the cleared list. Individual States were left having to call FDA to advocate for their areas of production. And there is a serious question of equal treatment for all producers. And there was constant confusion about what data could be shared with industry and what could not. We went weeks asking for simple data such as the onset of illnesses, the geographic patterns of illnesses. We could have used knowledge from our food distribution systems to help in that process and were told the data simply was not available. Number three, the current system does not use expertise outside of the agencies that is available. Let me first say that industry input needs to be transparent and squeaky clean. We are not asking to run the investigation. But there is an abundance of knowledge in the industry about specific commodities, growing and handling practices and distribution systems, as you have heard from my colleagues, that can help protect public health. As this outbreak expanded to dozens of states around the country we knew very early that it was highly unlikely that a single contamination point for tomatoes was possible, whether a single farm, packer or repacker. But industry's knowledge was ignored when it could have helped shift attention quickly to some other product, perhaps jalapenos. The FDA and CDC should also welcome outside expertise not just from industry but also from academia, from USDA and state departments of agriculture. Number four, we believe government is ill prepared to make complex risk/benefit decisions in the food area. Every health or safety regulatory decision requires an assessment of risk and benefits. Yet in the case of food-borne disease FDA and CDC seemed ill prepared to grapple with risk management other than an all or nothing approach. This leads to the extreme measures of banning all tomatoes or banning all jalapenos in the quest for zero risk. But is it really zero risk when 99.999 percent of the tomatoes available in the market are perfectly safe and we are scaring consumers away from a high-lycopene product that can protect against prostate cancer? There is another part of public health that we have to take into account here as well as the concept of talking about the entire tomato supply. Finally, the risk communication process that is in use is unacceptable. These are tough issues. They are tough to explain. But how many times have we listened to CDC and FDA media calls where the first 5 minutes was explaining there is nothing new in the investigation and the next 55 minutes are explaining and speculating about what may have happened, what may be happening, what may be plausible, what may be theoretical, but not what the facts are. Yet any risk communication expert would advise precision and care in communicating exactly what you want to say and not speculating beyond what is known. Mr. Chairman, much of the discussion today I think is going to focus on traceability. I would like to add some perspectives on that perhaps in the question session. My colleagues I think have shown you some of the industry experience with traceability. Frankly, we are confused. We do not understand where some of the problems the FDA is reporting in our system so it is something that we really do want to address. Thank you. [The statement of Mr. Stenzel follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Mr. Hubbard, we will turn to you for your opening statement. And we all talked about our ninth hearing, I think you have been here for all nine. We appreciate your work and willingness to work with us and your patience and your insight to this issue. So we look forward to your testimony, please. STATEMENT OF WILLIAM K. HUBBARD, SENIOR ADVISOR, COALITION FOR A STRONGER FDA Mr. Hubbard. Thank you, Mr. Chairman. I do have written comments but I will make just a few oral ones. It is unfortunate that we are here yet again talking about yet another failure by the FDA. And I am sorry you are having to go through that but I think the public is sorrier. As you know, I have expressed the view that many of the problems have not been of FDA's doing, that there have been shortfalls other places that have caused FDA to be ineffective. And I think there are many issues for Congress to deal with in this particular outbreak, how the government is organized, how the FDA is organized, how federal/state relations occur, how well the industry can track and otherwise do its job. But I would like to focus my comments, if I could, just on three areas all dealing with FDA's capacities. First, the agency's food safety resources have not kept up with the responsibility they have been given. And in fact, we have been taking down the food safety system at FDA for several years. We are reducing staff at a time in which we need people even more at the agency. We need more inspections. We need the scientists to deal with these emerging pathogens. And it has been going the other way. So I think that is a tremendous piece of the problem at FDA. By taking down a program at a time it needs to be strengthened we are simply going the other way. But FDA also needs to be able to acquire a food process to implement a system of preventive control. We need to prevent these things from occurring, not just chase them after the fact. As you know, preventive control is a well-proven mechanism for keeping food safe in the first place from being contaminated. Mr. Dingell's bill attempts to do that. And I certainly wish you well in that effort. You may know that FDA tried to use its existing authority last year to impose preventive controls over produce. But the Administration rejected the recommendations of the agency scientists to do that. And I think that has proven to be a grievous mistake. Just think, we could be well on our way to having regulations for preventive control for produce in effect today but essentially we are nowhere because of that denial. So I think that was a tremendous mistake. And I urge Congress to proceed with its efforts to establish a system of preventive control. My third point relates to traceability. When Congress enacted the Bioterrorism Act in 2002 it intended to give the agency the authority to track these products so that you would have a rapid ability to follow up on a potential terrorism attack throughout the supply chain. But instead of having a robust recordkeeping system that allowed for rapid access to complete records by all participants, the agency got, ended up with delayed access to partial records from only some elements of the supply chain. So we have weakened those regulations tremendously. And I think the Salmonella incident demonstrates how the weakening of those rules essentially negated the intent of Congress. So just imagine, Mr. Chairman, if the Salmonella outbreak had been a terrorist attack and thousands or hundreds of thousands of people had been at risk from death and disease how much of a failure those rules, that recordkeeping requirement would have been. And I think we need to look at in that context for future consideration. Now, the good news is, as Ms. DeGette and others have said, there are effective technologies available to provide for successful trace-back. Some produce firms have demonstrated it. But the problem is we are only as strong as our weakest link. And those small firms that have not been able to do effective trace-back I think need to be addressed. So the means are available to improve the situation. And I hope you will be a strong supporter of those means. Now in conclusion, Mr. Chairman, we talk a good game about food safety. We say we care about it, we say we are going to do more, but we just have not backed it up, that rhetoric up with necessary support in my view for FDA. I do not believe we can make FDA an effective agency without giving it additional resources and authority. These problems that we are talking about are they going to keep going? We are going to have more of these outbreaks? This is going to be an endless process until we fix the system. So I hope Congress will agree with those and move to make it so. And thank you for giving me the opportunity, Mr. Chairman, to prevent those views. [The statement of Mr. Hubbard follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you, Mr. Hubbard. We will begin questioning. I guess the last 12 hours epitomize how this whole investigation has gone. About 9:00, 10:00 last night we got a release from the FDA about jalapenos in Mexico. And about 10:15 we had a correction. And 8:00, 9:00 o'clock this morning we had another one. So we have had about three releases in the last 12 hours on what is going on with this investigation. Now I do not know if that is the quality of the investigation or the fact we are having this hearing here today. But let me ask this question of this panel. Now, this investigation started out with Salmonella Saintpaul and detailing tomatoes. Has there been any Salmonella Saintpaul, Salmonella found in any tomatoes in the United States? I take it none; correct? None? OK. Then at the time when we started this May 22, the only State I understand that was growing tomatoes at the time would have been Florida; right? Mr. Brown. That is correct. Mr. Stupak. OK. So any other tomatoes would have had to come either from Florida or I guess Mexico would be the other source; right? OK. Mr. Brown. Florida. Mr. Stupak. I am sorry, put that up there, Mr. Brown. It would have been Florida? Mr. Brown. The primary source, Florida was the primary domestic supplier at that point. Mr. Stupak. Right. And then the other one would have been foreign countries---- Mr. Brown. Other one was primarily Mexico. Mr. Stupak [continuing]. Mostly Mexico? Mr. Brown. And as a matter of fact, Mr. Chairman, the morning after we were informed there was concern we provided data for a period of 30, 60 days---- Mr. Stupak. OK. Mr. Brown [continuing]. Prior to that where every tomato in the country came from. Mr. Stupak. OK. Now, we eventually get to the jalapenos, right, after Minnesota gets there. And believe it or not we got one today, OK. But Florida, Mr. Booth, you mentioned about Florida and, Mr. Brown, you mentioned it, your process you have for tomatoes, the box and all the markings. Did the FDA help you with that? I mean were they aware of your system? Did they help you develop it? Mr. Brown. We have had positive lot identity for round tomatoes in Florida for going on close to 20 years under a federal marketing order. Mr. Stupak. OK. Mr. Brown. We had worked with the FDA in working up on state regulatory program that we were voluntarily implementing and we now have under state regulation. Mr. Stupak. OK. But as of today tomatoes are still suspect; correct? Mr. Brown. Unfortunately. Mr. Stupak. Or as we call it, the vegetable of interest; right? The person of interest, it is still the vegetable of interest? Mr. Brown. Yes, sir. We are still indicted and convicted in the media. Mr. Stupak. OK. But yet we have never had any. And now we are at jalapenos from Mexico; right? Mr. Murphy. Do not touch it. Mr. Stupak. OK. I have a double dare with Shimkus, we are going to eat it yet today. This is a box we got today. There is no markings like you had to show your area; right? All this says is ``Produce of the United States, net weight 25 pounds.'' And just says tomatoes on it. OK, we got it at a local retailer here today. Now, Mr. Booth, your box had those markings on it. Is it legal to use your box? I mean you ship it to, let us say you ship it up here to Washington, D.C., OK. And can a grower take that box with those markings on put tomatoes in it even it was not from Florida? In other words can you re-use that box again and again and again? Mr. Booth. As long as they maintain the records. Mr. Stupak. OK. But they would have to wipe out the coding that you have on it? Mr. Booth. They would have--when a repacker takes that they are going to have to when they repack it they are going to have to take the original lot number---- Mr. Stupak. OK. Mr. Booth [continuing]. The original information and put their own information on it. Mr. Stupak. OK. Now, only California and Florida have that system; right? Mr. Kawamura. Yes. Mr. Stupak. So the other 48 States are, they can be sending boxes like this here; correct? Mr. Brown. Mr. Chairman, this is why the industry has stepped forward in conjunction with FDA and the---- Mr. Stupak. Correct. Mr. Brown [continuing]. Research community and created this document which would resolve and solve that issue in requiring that every person in the country that grows and handles tomatoes maintains that information, passes it up. Mr. Stupak. So you want a federal regulation saying---- Mr. Brown. Yes, sir. Mr. Stupak [continuing]. You must do it this way? Mr. Brown. We want a double-phase procedure---- Mr. Stupak. Whether it is tomatoes, jalapenos, whatever it might be? Mr. Brown [continuing]. Because the public trust is so important to us we cannot afford to do it any other way. Mr. Stupak. OK. What is the cost of doing that, of putting that code on there and have that trace-backs? Can anyone give me an estimate? Because that is always a question we ask, What is it going to cost us? Mr. Booth? Mr. Booth. Yes, it is---- Mr. Stupak. Mr. Stenzel? Mr. Booth. I am not sure what the cost is. In the largest-- -- Mr. Stupak. Is it minimal or? Mr. Booth. It is minimal. Mr. Stupak. It is minimal? Mr. Booth. It is minimal. Mr. Stupak. OK. Mr. Booth. Anyway, the point being is that any size firm, large or small, can do this. Mr. Stupak. OK. Mr. Booth. It does not have to be fancy and it does not have to be expensive. Mr. Stupak. OK. Now, you said, Mr. Beckman, you traced back that tomato that you did in California for the staff and they learned a lot from you guys. That was all within California though; right? Mr. Beckman. It was. But---- Mr. Stupak. So what if that tomato goes to Michigan where I am from? Mr. Beckman. We actually were able to produce for the investigative staff a number of trace-backs throughout the United States. That included product from California, Florida and Virginia going into multiple states. For example, one of the trace-backs was from California to Colorado. Mr. Stupak. How long did that take? Mr. Beckman. That one took about 5 hours. Mr. Stupak. OK. Mr. Beckman. But I can give you a story that took place yesterday if you would like? Mr. Stupak. OK. But the point is you can do it; right? Mr. Beckman. Yes, we can. Mr. Stupak. And there is minimal cost? Mr. Beckman. Cost actually that we can say it is a part of a business culture and it is not significant. The cost that we pay in California to validate our process runs about a penny a box. Mr. Stupak. OK. So let us go back to Florida, let us go back to May 22. We have Salmonella, Florida is the only place growing, but Florida has this system, right, to track everything? So if people were getting sick in New Mexico and Texas that seemed to be June 3 is when they put the place out, could they not have gone and said, OK, Florida, have you sent to Texas and New Mexico in this area, wherever it is? Could they have done that? Mr. Brown. Yes. They were advised in early conversations that the supply chain or supply system for tomatoes in the country is basically bifurcated by east and west. Mr. Stupak. Yes. Mr. Brown. Florida dominates the eastern supply system, the Mexican supply source dominates the western supply system. And because of the energy costs we do not move them back and forth very often. Mr. Stupak. Right. Mr. Brown. And there may have been some minimal amount of tomatoes in that marketplace but they would have been insignificant. Mr. Stupak. California then would have been the big supplier to Texas, New Mexico then at that time? Mr. Brown. Only when they come into production. And they follow us. We were at a transition zone between. Mr. Stupak. When does California go in production? Mr. Kawamura. California had started this year on May 17 was the first field harvest of California. Mr. Stupak. OK. So we are on June 3, so they could have possibly been? Mr. Kawamura. No. At that point knowing what the initial outbreaks as they took place we knew that California had not been in production at that time and were able to verify that with FDA at the time. Mr. Stupak. So why did we make tomato vegetable of interest then? Mr. Kawamura. It was still a vegetable of interest throughout the rest of the production areas of the state. I know one of the early announcements from FDA was that California was not a part of this outbreak based upon the harvest schedules that we were aware of. Mr. Stupak. OK. Could country of origin labeling have narrowed the focus here in your estimation, anyone? Mr. Beckman, anyone, would that have helped? Mr. Beckman. It could perhaps help. But the problem was that the association was with all tomatoes. And so we had a scenario where all tomatoes were suspect. And then as the safe list was produced we are essentially trying to back individual states away from an association of guilt, and that is extremely difficult. Mr. Stupak. So the thing we need right now from the FDA is a firm statement that tomatoes are not even vegetable of interest, they have nothing to do with this Salmonella outbreak. Because we still, if I look at the last line here, it says, ``FDA announced that it has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency removed its June 7 warning.'' And my problem is with that is they never cleared tomatoes from the original outbreak. Mr. Beckman. Correct. You are correct, Mr. Chairman. Mr. Stupak. So we still have the suspicion over the---- Mr. Bronson. Well, Mr. Chairman, if I---- Mr. Stupak. Yes, go ahead. Mr. Bronson [continuing]. Might as well enter in this, one of the things that we noticed very early on was when the outbreak took place in Texas and New Mexico and began to go north of there we were selling tomatoes out of Florida all over the southern United States, all over Florida, but we did not have sicknesses in Florida. So we were suspicious right then-- -- Mr. Stupak. Right. Mr. Bronson [continuing]. That Florida tomatoes, grown tomatoes were not a part of this problem from the very beginning. And I think we need to while we have to follow the scientific method, we also should not throw away common sense and risk assessment that says if you know this is where the outbreak is the most seen there is a good chance it is coming either across the border or from within a state or two of that outbreak because the south had no cases at the time. And the other issue, Mr. Chairman, that I would like for you to consider, because someone from Florida goes to the doctor with a sickness that ends up being Salmonella Saintpaul they may have gotten it in Texas. They should not be---- Mr. Stupak. Sure. Mr. Bronson. They should not be counted as a Florida sickness because it may have been picked up while they were traveling. And that is the case in a number of these cases. Mr. Stupak. Well, I am looking at the CDC investigation outbreak of infections caused by Salmonella Saintpaul, dated July 29. And when you look at it they have the breakdown of 1,319 people, 1,319 people infected, only 11 are from California and 4 from Florida. So with the math of course being Texas with 502 and New Mexico 106, so I guess that proves your point. One question and my time is way over, and I just want to ask Mr. Hubbard a question. Because we are talking a lot about traceability here and suspect vegetables or not, but let me ask you this one. On July 25 the Associated Press ran an article entitled ``Food Industry Bitten by its Lobbying Success. Companies Oppose Electronic Tracking that Could Locate Outbreak Source.'' The gist of this article is that there were some with the FDA that were advocating a much stronger recordkeeping and trace-back system than what we currently have today underneath the Bioterrorism Act. However, due to heavy pressure from industry many of the requirements were watered down. Mr. Hubbard, you were an associate commissioner of policy at the FDA at that time. What systems were being proposed? And how did these systems differ from what we are using today or what we have seen in California and Florida? Mr. Hubbard. Well, as I said, I think the agency wanted a lot of the things that folks are talking about here now: lot numbers, rapid access, recordkeeping throughout the chain. I will not deny that the industry may have had a ``Come to Jesus'' moment in recent years, but in 2003 the message from the industry to the Office of Management and Budget which was reviewing the regulation was too expensive, too hard, do not do this. So again I am very gratified to hear the progress that has been made, but when FDA was doing its regulations it was being literally hammered for proposing things that were viewed by many members of the industry as too much. Mr. Stupak. One more. Mr. Beckman, did it not really say, tell our staff that to do that tracing on that box there is it not like a penny a box? Mr. Beckman. It is a penny a box for the verification. The actual costs are, again, insignificant. Mr. Stupak. OK. Mr. Shimkus for questions. Thank you, gentleman. Mr. Shimkus. Thank you, Mr. Chairman. Good round of questions. Maybe we should go ten minutes one round or whatever, so. Whatever. But it is all, you know, I like to talk about on the business end and talk about raising of capital, assumption of risk, return on the investment. And part of this is a payment to lower the risk. And obviously there has been a big loss. Now, the growers have intimated that obviously there should be some recovery. And there could be a debate on takings based upon response. And I do not know if and how that will resolve itself but, you know, the thing I want to focus on to begin with, I had a whole bunch of scribbled notes from the testimony, it is very good. But first-off for Mr. Bronson. And we have the time line here and so June 3, 2008, FDA warned consumers in New Mexico and Texas not to eat certain types of raw red tomatoes. Now, your opening statement said you were 99.9 percent sure it was not Florida. On June 3, how close to June 3 did you know there is no way it was a Florida tomato? Mr. Bronson. Congressman, we, because of our program that we implemented and third party verification which is as close to ``HASUP'' in most other fields of food safety as you can get the fact that we had no single person in the State of Florida that was showing Salmonella Saintpaul or any other kind of Salmonella that we were aware of because our people in our county and State health departments would have been in touch with us if it had shown up, we had that good a working relationship, and the fact that we were shipping all over the southeast United States and there was no cases. Mr. Shimkus. But what is the date? How close were you to that June 3 time frame you said it is not here? It highlights the communication of the FDA; that is the only reason why I am asking it. Mr. Bronson. June, well, I am saying, I am hearing now from my deputy commissioner who is in charge of food safety, around they were very sure by the time we analyzed what we were getting by the 15th of June---- Mr. Shimkus. All right. Mr. Bronson [continuing]. There was no way Florida was responsible because no Florida tomatoes---- Mr. Shimkus. Well, the only thing I am highlighting, we know there are areas to be fixed. One is communication, you all mentioned it, communication across the board with all agencies, transparency. And an early notification of information and acceptance could help limit losses I, you know, I think, and that is an issue. But I want to highlight, I mean we are all FDA, beat up FDA. Trace-back although it was slow, Mr. Stenzel, trace-back worked in this system, did it not? Mr. Stenzel. I think, Mr. Shimkus, that you have identified a very key part of our discussion here. The real issue where this started is in the identification of tomatoes at the CDC. Everything in trace-back would prove that tomatoes were not the cause. Everything that was traced back showed tomatoes came from different sources. There was no common point of contamination. Could that have been done more quickly, more effectively? If it could I want to know how. I want the FDA to show us where they ran into roadblocks. These types of systems that my colleagues have talked about are precisely in place also for many Mexican tomatoes. So many of the tomato products in this industry, because it has been bitten in the past, have done a fantastic job of putting in place extensive traceability. So we do not understand what that slowness was. But in this case traceability showed tomatoes were not the cause. Mr. Shimkus. 1,400 samples, not one--all right, one positive. And the key, you know, really we ought to have a hearing from the CDC and the State health departments. I mean that is the hearing today ought to be. I mean because that is where in this case the system failed. Mr. Stenzel. Mr. Shimkus, I think it is very difficult, and this is an issue that I think you have got to grapple with with the agencies, is how do they back away from an initial association? They still will not do it. They are still even in the press releases today clinging to the theoretical plausibility that perhaps tomatoes from near these Mexican farms might have been involved in the early stages. I guess that is still possible and we will have to hold judgment. But my goodness, we now know that the initial month of activity that said tomatoes are it and, by darn, we are going to prove tomatoes are it; they did not do it. They just found tomatoes were not it. Mr. Shimkus. Mr. Hubbard, you have to agree that as much as we are focused on FDA it is this issue of the CDC and the public health departments and why they did not--I am not a criminal investigator but, you know, when we were doing, I was doing the prep for this it was my understanding they limited the suspects instead of having all the suspects like, you know, everyone in the room instead of they focused on, they focused on a commodity product not all the commodity products? Mr. Hubbard. Absolutely. FDA chases the food that the CDC questionnaire process identifies. And epidemiology is an inexact science. And I am sure you will hear that from the CDC folks. I am sure they did the best they could but FDA was chasing down the results of the CDC recommendation. Mr. Shimkus. And let me go to Mr. Beckman real quick because I want to follow up. I think I made my point on the CDC and the public health departments. But this issue that we did on tracing the tomatoes to the retail location which was a Jack In The Box, the Chairman followed up with across state lines. The question I would ask is smaller mom and pop retail locations, family restaurants, or tomorrow is Friday, my American Legion Post 365 does a weekly fish fry. Of course the only way Illinoisans love to eat fish is cod and it is deep fried. So and they will have tomatoes. Can this process that we are talking about, obviously a major retailer, just that whole debate, have the resources, can do the IT, can do all the process. What about my local American Legion Post 365 that really relies on the fish fry to bring in income to help fellow veterans? Can they do that too? Mr. Beckman. Well, first let us look at the State of California and the fact that in the California code all tomatoes must be traceable at all points in the system. That includes the smaller players. But to answer your question as to outside of California, again referencing the Tomato Supply Chain Guidance document, what we looked at is where are the weaknesses in the Bioterrorism Act? Is there a weakness in the fact that an individual mom and pop restaurant is not required to maintain such a level of documentation? Trace-back can simply begin with an invoice, an invoice that we recommend in this document be held for at least 6 months so that way we know where those tomatoes came from. There has to be that initial piece of paper. Right now those outlets are exempt from the Bioterrorism Act recordkeeping requirements. Mr. Shimkus. Let me go to Mr. Booth for a second and talk because you deal with all, you are a grower, you are a supplier, you are a repackager. Mr. Booth. Right. Mr. Shimkus. What about the repacking? Repackaging of the other thing in our research talked about sizing of tomatoes from maybe different growers; does that happen? And then how do you, say you are a repackager and you have a multitude of growers and so they are coming in your facility, you are repackaging by size and weight versus where it came from, so then in that box could there be more than one? And does that code then does it identify that this came from four different locations versus one location? Is that how that works? Mr. Booth. Yes, well maybe I can just take a minute and just give you an example of how that might work. We will buy at any given time from multiple growers. Today this minute Delta, our repack company, is actually purchasing product that we actually grow in multiple different fields. We are going to be purchasing this week product from other growers, competitors to our other baseline company Ace Tomato. The way we handle and the lot identification is identical whether it is our product coming from our fields or from another grower. And that grower could also come from Mexico. So it is identical. The product comes in to our repack facility. We run that product to size and spec, specifications that our customers give us, by lot. So that one lot goes all the way through our process. So in a box that I just showed you a few minutes ago you will have one lot of tomatoes in there, just one. Commingling has been talked about a lot. And I think that has been discussed and it is a little bit confusing as what commingling really is. If you do have multiple lots in one case you need to make sure that you have got the documentation to prove that there are multiple fields, multiple lots in that box. We do not want to do that. We really do not want to mingle a particular box. As I showed your congressional investigators, on a pallet you may have one case out of 80 that is from a different lot than the other 79 boxes. As long as you have the documentation that shows that that box came from a particular lot you are OK, you can trace that back. And if there is an outbreak or if there is a suspected outbreak of a particular case that goes to that restaurant you can again follow that all the way back to the lot. Mr. Shimkus. My time has expired, Mr. Chairman. Thank you again. I will want to end by saying CDC, state health departments, we have to bring them in the loop and empower them to make some better decisions. Mr. Stupak. Ms. DeGette for questions. Ms. DeGette. Thank you very much, Mr. Chairman. I really want to thank each of you on this panel because you have really, quite thoroughly explained to us that we can do traceability, that it is cost effective and we can do it even with mixed lots. What I want to talk about is why do we need to have some kind of a national system of traceability? Now, Commissioner Bronson, in your State you have mandatory traceability for tomatoes; correct? Mr. Bronson. That is correct. Ms. DeGette. And also, Secretary Kawamura, we have that mandatory traceability in your State as well for tomatoes; correct? Mr. Kawamura. Yes, we do. Ms. DeGette. And, Mr. Beckman, you talked today and also I met with you and you talked to me about how quickly and effectively we can trace tomatoes if we have a traceability system; right? Mr. Beckman. Correct. Ms. DeGette. In fact, the story you wanted to tell Mr. Stupak was you folks bought some sandwiches at Subway and went and ran a trace on those tomatoes at Subway and you were able to do it in a few hours; right? Mr. Beckman. Correct. Ms. DeGette. And that is because Subway requires traceability for its tomatoes; right? Mr. Beckman. Ms. DeGette. I am not sure that the whatever it is the fish fry people might have mandatory traceability. But that---- Mr. Shimkus. No, I do not think we do. That is the whole point. Ms. DeGette. Exactly, that is the whole point. And so, Mr. Stenzel, you might be able to answer this broader. We are really clear on what is going on with tomato traceability but part of the problem we have is we do not have national tomato traceability; right, Mr. Beckman? I mean some industry, some producers have it, some industries, some states have it. But it is not a national system; right? Mr. Beckman. It is fair to say that if you are a major tomato grower and shipper and want to do business with major corporations you absolutely must have it. That is not to say that there are not some growers in some areas of this country that do not maintain traceability. Ms. DeGette. But in addition its traceability, it is vertical traceability not horizontal traceability because it is traceability for that grower? It is not a national system of traceability that the national tomato growers have instituted for everybody? Mr. Beckman. Well, traceability begins at the grower/ shipper. Ms. DeGette. Well, can you--I am sorry, I do not have a lot of time. Mr. Beckman. OK. Ms. DeGette. Yes or no? Mr. Beckman. Please repeat the question. Ms. DeGette. Is it a national system of traceability that is interoperable for all of the tomato growers? Mr. Beckman. It is not a national system, no. Ms. DeGette. OK. Mr. Stenzel, now you represent broader numbers of growers. And I understand the way you trade a tomato may not be the same way that you would trace green beans or other produce; correct? Mr. Stenzel. Correct. Ms. DeGette. But there are other types of traceability systems that would work for almost any kind of commodity; correct? Mr. Stenzel. Yes, ma'am. Ms. DeGette. And so what I have been thinking about is this recent Salmonella outbreak. And it appears that what happened is people, let us step all the way back to the beginning, the public health sleuths talking to people found out that they had eaten probably salsa or something that had tomatoes and chili peppers in it; correct? Mr. Stenzel. Yes, ma'am. Ms. DeGette. And so if you were trying to do traceability on that it would be really helpful if you could break down the components of that and be able to trace them, whatever the system was; is that right? Mr. Stenzel. Certainly in any processed food or a mixture of different ingredients it gets much more complex, but you would want to be able to trace the individual ingredients. Ms. DeGette. And that would have helped us in this situation if--I mean it would have helped the tomato industry if the FDA investigators and the CDC would have said, OK, let us trace all of the tomatoes that were involved in this salsa. And if you had had a quick system you could have resolved the tomato problem much more quickly than it was resolved I would assume? Mr. Stenzel. Well, I think our concern, Congresswoman, is that we believe that across the board there are these systems in place, particularly in the tomato industry and that the trace-back actually showed that it was not the tomatoes. Ms. DeGette. OK. Mr. Stenzel. This was not a matter of inability to track tomatoes and where they came from. Ms. DeGette. Right. Mr. Stenzel. It was the confusion with other ingredients that perhaps were in the salsa. Ms. DeGette. Well, let us talk about that. So let us say we had a traceability system, a trace-back system for jalapeno peppers and cilantro and the other ingredients, if that would have moved faster we would have been able to resolve this situation much more quickly to the benefit of the growers of the vegetables that were not contaminated; right? Mr. Stenzel. Our industry had the highest incentive to resolve these things quickly to protect health and to prevent damage to the industry. Ms. DeGette. Exactly. Mr. Stenzel. If the CDC scientists had had any concerns about other ingredients they could have been tracked. Once the investigators started looking---- Ms. DeGette. Do we have the same kind of system for jalapenos that we do for tomatoes? Mr. Stenzel. Not nearly as effective. But once they started looking for jalapenos they have tracked them extremely effectively. Ms. DeGette. Right. But if we---- Mr. Stenzel. The fact that the individual farm in Mexico today with today's traceability with one of the most complicated small items that does not have these elaborate systems. Ms. DeGette. Right. But if we had a national system, not maybe one type of traceability but if everybody had to do it and it was interoperable we could have done this much more quickly; would that not be fair to say? Mr. Stenzel. I am not convinced that the traceability investigation of FDA was the lagging factor in this case. Ms. DeGette. OK. Mr. Stenzel. We definitely need---- Ms. DeGette. You think it was the identification. Mr. Stenzel. We need to improve our traceability. And that is something the industry is taking very, very seriously. Ms. DeGette. OK. Mr. Stenzel. And a national program in the tomato industry I should also say is important. Ms. DeGette. OK. Mr. Stenzel. One key---- Ms. DeGette. Excuse me, I am sorry, I do not have much time and I have one more topic I want to talk about with Mr. Hubbard. And welcome back. Mr. Hubbard. Thank you. Ms. DeGette. I was just telling staff I feel like we should just put you on the roster every time we have an FDA hearing. I want to talk to you about the 2002 Bioterrorism Act because some people have said that provides us with the federal tools we need to do traceability. And I know you do not entirely agree with that and I wanted to explore that with you. In your testimony you provide a side-by-side analysis, in you written testimony, of the key weak points introduced into the original legislation and regulation as it was reviewed and considered by administration reviewers. So I want to go through those because I think that kind of gives us some sense why maybe that act is not helping us trace as much as we want. What you say is what FDA wanted or needed in the final rule, that FDA wanted records by all sources and recipients, but farms and restaurants were excluded; correct? Mr. Hubbard. That's correct. Ms. DeGette. And FDA wanted foreign firms as well as U.S. but the foreign firms were excluded from the final recommendation? Mr. Hubbard. In the rulemaking process, yes. Ms. DeGette. They wanted a complete record of the food's movement but what ended up, and I think this is maybe the biggest flaw, is only one step up and one step back; correct? Mr. Hubbard. That is correct. Ms. DeGette. They wanted lot numbers for each shipment and that was denied in the rulemaking; correct, Mr. Hubbard? Mr. Hubbard. Absolutely. I mean the consumer groups pushed very hard for that but the industry view was that lot numbers would be too expensive to maintain. Ms. DeGette. And the FDA also wanted electronic records for speed, and that was denied; correct? Mr. Hubbard. Obviously, yes. If you can just go on the computer and punch it up you can do it a lot faster than going through thousands of pieces of paper. Ms. DeGette. They wanted records access within four hours and that was extended to 24 hours; is that correct? Mr. Hubbard. Right. Four hours during normal business hours, 8 hours if they asked in the middle of the night, but it got extended to 24. Ms. DeGette. They wanted a consistent record format, and that was denied; correct? Mr. Hubbard. Yes. I mean FDA inspectors---- Ms. DeGette. Now why is that important? Mr. Hubbard. Well, FDA inspectors are now finding they will go into a firm and some of them will have great records and others will have just bills of lading. And I have had anecdotal examples given to me of people have records on a plain paper bag or other, you know, all kinds of different formats where you have got to really search through for the various information you need instead of it all being there rapidly accessible. Ms. DeGette. And that was part of the problem with this recent Salmonella outbreak is the records problem? Mr. Hubbard. Absolutely. I mean one anecdote was a Florida tomato packer I am told literally ran out of supply and could not get anymore Florida tomatoes so he bought some Mexican tomatoes. Imagine how that could complicate a trace-back by FDA to have this foreign product enter into the Florida main, into the Florida stream when, you know, that could just be a tremendous fly in the ointment as they say. Ms. DeGette. Furthermore, the FDA wanted authority to verify the keeping of records, and that was also denied; right? Mr. Hubbard. I am sorry, I---- Ms. DeGette. The FDA wanted the authority to verify keeping of records? Mr. Hubbard. Yes, the problem here is the way the rule was set up if an inspector goes in to do a routine food inspection they say, well, let me see your records in case there is ever an outbreak, the firm can say, no, you can only see the records if there is an outbreak. So the inspectors are not able to confirm that the industry is doing what they need to do to prepare for when there is an outbreak. And that is kind of nuts if you ask me but that is the way the rule came out. Ms. DeGette. Now let me ask you this, when you say the FDA wanted or needed, that sounds like a pretty good description of a national traceability system as these gentleman have been describing today, does it not? Mr. Hubbard. Oh, absolutely. Ms. DeGette. If we gave them these authorities, let me just ask you in your opinion, would this investigation and further investigations have been expedited so that we could protect public health and also industry? Mr. Hubbard. I think that to the extent trace-back was the issue they could have much more rapidly identified that tomatoes were being excluded and then the industry would have been spared a huge expense and they could have gotten to the peppers more quickly and a lot of people would have been saved a lot of distress, absolutely. Ms. DeGette. Thank you very much, Mr. Chairman. Mr. Stupak. Thank you. Mr. Burgess for questions, 10 minutes. Mr. Burgess. Thanks, Mr. Chairman. Mr. Stenzel, I apologize for being in and out but for the other hearing going on. In response to a question by Ms. DeGette of Colorado you said that traceability was not the lagging factor. You started to tell us what that was, so would you tell us what that was? Mr. Stenzel. Yes, sir, thank you. The initial identification of tomatoes as the sole source of contamination really sent us down, you know, the wrong path. As Mr. Hubbard said, it is FDA's responsibility then to investigate precisely what CDC has already identified as the villain or the vegetable of interest if you will. In that process we have heard claims that there was slowness or slow in traceability. But as you have heard from other witnesses here on the panel, we do not understand where that slowness would have occurred. We need to see the specific examples, not the anecdotal stories. It is not uncommon for growers to substitute new product from other regions but they can keep track of that quite well in the systems that are in place. So we do not understand where that slowness would have occurred. The initial time that FDA did a trace-back from someone who was ill in Virginia and it went to a Florida farm and then they did a trace-back of someone who was ill in Illinois and it went to a Mexican farm, they should have known it was not a common source. That could have happened in the first day, the very first day we could have done trace-backs, I think we did do trace-backs. And I would like to understand what trace-backs were done to confirm that there was not a common source of contamination. Why did it then take 3 week or 4 weeks? There was a bias, I believe, in terms of we must prove it is tomatoes because that is what CDC has said, that was their epidemiological evidence. Until we got off that horse and realized that there was something else that we had not figured out early enough, by well-meaning scientists but we had not figured it out early enough that it was really something else causing the illnesses. Mr. Burgess. We talk a lot up here about things like mandatory recalls. Going down the wrong path like that, had there been a mandatory recall it might have in fact been more deleterious to the industry; is that correct? Mr. Stenzel. I cannot imagine it would have been worse. We have a mandatory ban of all tomatoes, so we pretty much suffered. Our industry, the produce industry, supports mandatory recall authority for the FDA. But their press releases are pretty darn effective too. Mr. Burgess. OK. Let me, Mr. Hubbard, again, and thank you for being here. Like Ms. DeGette I feel like you are part of the committee you are here so frequently. You mentioned in your testimony, and I was watching it on television upstairs, you said that we are only as strong as our weakest link, and this thing under the Bioterrorism Act, the exception for a company that has 10 or fewer employees keeps coming up. Do you have an opinion as to how that weak link might be tightened up so that we do not face these problems? Mr. Hubbard. Sure. This is an old story at the FDA that small firms tend to drive rulemaking because even though small firms, in this case I imagine 90 percent of the fresh produce is managed by large firms, but there is usually a large number of small firms and they make a powerful argument that a strict regulation could drive them out of business or adversely affect them. Here I would think with the kind of technology Ms. DeGette's talking about available I would hope there would be ways to identify---- Mr. Shimkus. Will the gentleman yield? Off of the record this is Diana DeGette. Ms. DeGette. Thank you. Mr. Hubbard. I apologize. Mr. Shimkus. So, my colleague from Texas and Mr. Hubbard. Now we are on the record. Mr. Hubbard. I apologize. Ms. DeGette. It kind of sounds more exotic though. Mr. Burgess. It does. That is why I used it. Mr. Hubbard. There could be off-the-shelf technology or other inexpensive ways to give the smaller firms access to the kind of tracing mechanisms that Ms. DeGette has mentioned as the proper way to do it and reduce some of those costs. But clearly the costs are going to drive decision making here unless we can help the small manufacturers, and in this case the small produce producers. Mr. Burgess. Is it an issue of being able to provide them the funding or the back-up for those systems or is it just simply getting them into the process? Mr. Hubbard. Well, I think it is more the latter. Imagine you are, you know, you are the small producer and you are not sophisticated in technology, you do not have the funding to have an expert come in an create a system from scratch, but someone says, look, there is established software and hardware that you can purchase and get into the system with the big guys, I would think that that would much, much lower the cost for those if they had easily off-the-shelf access to the technology. Mr. Burgess. Let me ask another question. I mean you heard my anxiety about the inability to actually do something definitive on the Friday where this was all finally sorted out that peppers are the culprit. And again on T.V. we are hearing the FDA's recommendation is you ask where the peppers came from. And that seemed like a fairly incomplete response to be delivered. Is there something better we can do when we find there is a problem? And we talked about mandatory recalls and let us do everything that they do. But at the same time we have to have a way, I think, from stopping that stuff from coming in the country. Our border has to be secure from preventing what we have now identified as a contaminated product from entering in the stream of commerce. Mr. Hubbard. Well, first of all, in terms of communication to the public, imagine CDC or FDA had said we are 90 percent certain it is tomatoes, or 80 percent or whatever, and they did not tell anybody because they wanted to be 100 percent, and it turned out it was tomatoes. You know, you would be having a different hearing but you would still be having a hearing. Mr. Burgess. Sure. Mr. Hubbard. And it would be really ugly. Mr. Burgess. In fact, we had that situation with Heparin in some respects. Mr. Hubbard. Sure. So I think that the agencies are in a bind and the key is for them to eliminate a given commodity very rapidly. And that is where things like trace-back and recordkeeping come into play so that these investigations do not run for weeks, they run for days. And then you cut it off and you are done and, you know, and you have solved the problem. Mr. Burgess. OK. That point of cutting it off, again Friday they found the problem but there was not really the ability to cut off that product. I mean how do we know how much product came across the border over the weekend? How do we know that by Monday morning we had not had more bushel baskets of contaminated peppers entering the stream of commerce? Mr. Hubbard. Well, as we discussed, the import problem is a tremendously problematic one. Conditions on these Mexican farms can be horrendous with farm animals traipsing through. And I understand that one of these farms that is the subject here even though they were told in advance FDA was coming when the inspectors got there they found all kind of problems, animals in the irrigation ditches. They only had two port-a-potties for the entire farm, and one of those had just been stolen. So, you know, you have got fundamental violations of preventive control technology that I would hope we do not see in the United States but we certainly do see in Latin America. Mr. Burgess. But as far as securing it at the level of the border is there a authority that the FDA could have that they are lacking at this point? Mr. Hubbard. Well, the only authority they have is to examine the product as it comes across the border. And as the committee has found, FDA does very little of that. They need the authority to put preventive controls in place back to the Mexican producer so that they meet the same standards U.S. producers make. Mr. Burgess. And I would not disagree with that except that, as you correctly point out, time after time there are violations and the standards do not seem to be where we would want them. It just seems to me that we have to have a way, there has to be a failsafe at the border when we discover we have a problem on a Friday afternoon that we do not just let it run then for the next couple of days until we can get someone down there on the farms and inspect it. There has to be, I think, and I think the American people want us to have the way to stop that from entering the stream of commerce the minute we detect that there is a problem. It may only be temporary. We may have to within a certain time period come back and address that. But we have to have the ability to stop that when we discover there is a problem. And, Mr. Chairman, in the interest of time I am going to yield back. Mr. Stupak. We are shocked but great. Ms. Schakowsky for questions please. Ms. Schakowsky. Thank you. I apologize very much for not being here for your testimony. There are a lot of hearings going on. But through the magic of my assistance from staff I find myself able to ask questions nonetheless. So let me start with some questions for you, Mr. Stenzel. Let me walk you through a key points of your testimony. Is it true that throughout the outbreak investigation you and your members really could not determine who was in charge of the investigation and this left local, State, federal officials vying for leadership? Mr. Stenzel. Yes, Congresswoman, in many of our conversations with officials from both CDC and FDA it was unclear who was making the decisions on public advisories, at what point in time which agency had the authority to advise consumers not to eat these tomatoes or this type of tomato. We saw repeatedly concerns between those two agencies. As far as the State and locals, this is probably more that we have discerned from our members, people doing investigations in the field who said that sometimes they heard from their State health departments a disagreement with the federals in terms of, gosh, we do not think it is tomatoes, I do not know why we are still chasing this. Ms. Schakowsky. Is it not also true that as a result of this various agencies related to this investigation, as you say, were--well, I guess you answered that--were pursuing different priorities which added to the confusion. So the priorities were both instructions for consumers, the source of the problem, those kinds of things? Mr. Stenzel. Yes, that is correct. Ms. Schakowsky. OK. Was not one of your chief concerns in this outbreak that field investigators across various agencies were not coordinated so it was difficult for your members to understand what kind of information authorities were seeking and what they could do to help the investigation? Mr. Stenzel. This is another important lesson I think as we look at trace-back as well. The field investigative staff while doing their best were not experts in produce, certainly not experts in produce distribution. We have anecdotal stories, as Mr. Hubbard told, of an investigator going into a warehouse in Philadelphia who said that they had been investigating heart transplant and heart valves the day before and now they are looking for tomatoes in a warehouse. We have cases where an investigator on contract to FDA comes in and says, give me all your records. It almost sounded like a ``go fish'' game. No wonder we cannot trace it with that kind of an approach. But with a very targeted, well-organized effort. Commissioner Bronson raised an important point I do not want to forget, the ability to task State departments of agriculture who are much more familiar with our systems to help in those investigations might, you know, be a very good lesson out of this hearing. Ms. Schakowsky. You suggest that Congress should consider how to put into place a command and control system with a clear chain of command during food outbreak investigations. So you are thinking that we ought to think more broadly and include state agriculture departments or that we should look at that chain of command more broadly as well as more efficiently? Mr. Stenzel. I think realistically we are going to have to have a collection of different agencies of local, State and federal working together. I do not simply see, you know, a total revolution at hand in change in our public health structure. But there does need to be some type of command structure I would suggest. I use the analogy of the National Transportation and Safety Board investigating an accident. You know that someone who flies to the scene, that person is in charge. Everything else flows through that investigation. There is one spokesperson to the press. The analogy, this one seems to be going in fits and starts in many directions. How we can pull that together in one more cohesive fashion. Ms. Schakowsky. Well, there is also industry expertise. And I know another primary concern of your members was that the government failed to use that expertise during the course of the outbreak investigation. What role should industry experts play? Mr. Stenzel. We believe that there has to be a very clear precaution taken. We do not suggest that industry run an investigation. But there is a lot of knowledge and expertise. You can hear it from these tomato people. There is expertise in jalapenos out there in the industry. And to be able to bring them in in an appropriate way for FDA and CDC to call on those resources. An example would be we mentioned the illnesses. There were very few in California, there were very few in some of the Mountain West States. We began to look at the distribution patterns of food distributors and could start to see why and where product may have been coming from. The jalapenos we discerned were probably coming on the east side of Texas, not the west side of Texas just because of the distribution patterns coming up through the Mississippi to Illinois. So that type of expertise. Ms. Schakowsky. Are there some legal constraints that regulatory agencies may have in sharing data or that you may have in sharing data? Mr. Stenzel. There may be. We are not familiar with what those are. Ms. Schakowsky. OK. Mr. Stenzel. But I think it is something the agencies ought to look at. And if there are impediments, is there a way that Congress could help them have a legal means to get that expertise. Ms. Schakowsky. I have a few more minutes so let me ask, Mr. Beckman, you communicated to committee staff that you believe in the future the FDA should attempt to use industry to assist in an outbreak investigation because they understand with regard to players and the complex distribution chain, as Mr. Stenzel just said. Let me ask your opinion on how you think industry could help the FDA? Mr. Beckman. Well, to give you an example, within the first 24 hours of our being informed of this outbreak it was brought to our attention by FDA that they were interested in ingredients that went into the production of salsa. There were follow-up discussions that continued. We did not fully understand though where this investigation was going and what information we provided if it would be acted upon. Really it seemed like there was a greater level of outreach by FDA but we were not able to ask the important questions to help connect the dots. There were some but we tried to shoot blindly---- Ms. Schakowsky. You were not asked? Mr. Beckman [continuing]. Trying to understand where FDA was going with this investigation. That was part of the problem. And it is my understanding that there are confidentiality issues that prevent them from disclosing specific points of the trace-back during the investigation. Ms. Schakowsky. Well, that is what I am wondering in the recommendations, perhaps both of you, because there are statutes, including the Trade Secrets Act, portions of the Federal Food, Drug and Cosmetic Act, even the Freedom of Information Act that makes it difficult to share information with industry. So in the face of those information-sharing limitations that govern the FDA do various associations represented here in conjunction with other produce industries plan to consider ways that would allow more industry assistance during outbreak investigations? Mr. Beckman. We would welcome any form of involvement that would include the restriction of the release of any confidential data. Any involvement that we can possibly have to help move FDA forward on a trace-back investigation. And we would welcome being held to any form of confidentiality law regarding our involvement. Ms. Schakowsky. OK. Mr. Stenzel? Mr. Stenzel. If I may, I suggested the possibility of a security clearance or some type of pre-vetting of industry experts that could be officially authorized and stand at the ready that FDA could call. They have already been preapproved and they would come 24/7 to help in an investigation like this. Ms. Schakowsky. Mr. Kawamura, did you want to respond as well? Mr. Kawamura. I would like to add that in my testimony you will note in the written testimony that we mentioned the leafy green marketing agreement which took place in California and now Arizona as well as a nice template for industry working collaboratively with governments both at the State level, as was mentioned earlier, and the federal level, both at USDA and also with FDA as a partnership to look at how we can bring those resources together, create standards and practices that allow for documentation for traceability. And I think that kind of effort shows that I think all parties want to move forward. Our discussion today continues to be on what happened in the past, but in moving forward on what can happen in the future the diagnostics that we are working with are incredible. To be able to trace genetically these different strains to a source back at a watering hole or in the field, these are the kinds of things that we should really be celebrating in our system. It is not to say that the system is not perfect, but I will continue to submit that this system is getting better because none of the groups that are represented here can sustain these kind of outbreaks and this kind of damage to the growers. I know we have not talked about compensation today for those growers. When you are unfairly pointed, unfairly implicated or incorrectly implicated in an outbreak I hope that becomes part of the testimony today as well. But I think what we want to do is how do we move forward hand in hand. I continue to say that for the amazing job that is done domestically in our country, the misunderstanding still comes with the lack of confidence or the collapse of confidence. How do we rebuild confidence with the American public that consumes ever day a billion meals a day, if you will, how do we recapture that confidence and show that the system is moving forward? Ms. Schakowsky. And you are suggesting that California may provide some model and some suggestions for us at the federal level? Mr. Kawamura. I believe both California and Florida have some models that can easily be used and put into place. Ms. Schakowsky. Thank you so much. I yield back. Mr. Stupak. Thank you. I have called on the FDA to do a post-mortem here on what went right and what went wrong with this investigation. Would you all be willing to serve on that panel if asked? Mr. Brown. We would love that opportunity. Mr. Beckman. Absolutely. We are ready to go. Mr. Stupak. Let me ask this. It came up and I am still a little confused. Tomatoes is the only one that really has this traceability that we have? Does jalapenos have them? Does spinach have it? Some are shaking heads yes, some are shaking heads no. Mr. Kawamura. In California the leafy green marketing agreement takes all those leafy vegetables and they do have a very comprehensive traceability and identification package. Mr. Stupak. OK. So the leafy greens, that would be the spinach that we have had problems with in the past. Mr. Kawamura. And many other, and many other of our products as well from California. Mr. Stupak. OK. Florida? Mr. Bronson. We do not have a full set yet but we are working on all the leafy greens to match what we are doing in tomatoes. But let me, Mr. Chairman, if I might let me say to you that even with the new law that has passed on country of origin, where these groups were found and the reason why we began to see that Florida was not a part of this was around a restaurant situation. Mr. Stupak. Right. Mr. Bronson. You understand that even with the new country of origin labelling it does not have to follow to the restaurant. Mr. Stupak. Correct. Mr. Bronson. And that is where one of the problems was in this outbreak. Mr. Stupak. Country of origin label is really an old law. We are just waiting for it to be implemented by the Administration. Mr. Bronson. Florida has had it for 20 years. Mr. Stupak. I know. I know. Mr. Bronson. That has worked for us. Mr. Stupak. I know. Mr. Bronson. I am glad it is coming into place. Mr. Stupak. I do not know why we cannot get it done up here. Let me ask this question. Let me ask this question. Because I want to go back to what I said earlier about those three press releases the last 12 hours sort of epitomize this investigation because we still have so many questions. If I am growing a tomato--and I am not a farmer, so bear with me--if I am growing tomatoes to I rotate my crop every other year and put a different crop in there to keep the ground good? I do that. What would be the other crop? Mr. Booth. Absolutely. For tomatoes you will rotate that every two or three years. Mr. Stupak. OK. What would I substitute then when I am not growing tomatoes in that field? Mr. Booth. It could be wheat. Wheat is a very good, a very common crop to. Mr. Stupak. OK. Mr. Brown. In contrasting it, Congressman, in Florida we basically grow tomatoes on the same piece of land year after year after year with the technology we have in place. Mr. Stupak. OK. Because going back to these press releases that I mentioned it says, you know, ``previously FDA inspectors collected a positive sample of jalapeno pepper from a produce distribution center owned in McAllen, Texas. The FDA continues to work on pinpointing where and how in the supply chain this first positive jalapeno pepper sample became contaminated. It originated from a different farm in Mexico than the positive samples of serrano pepper and irrigation water.'' So this tells me, OK, we still have not cleared off tomatoes yet, as we talked about earlier. And the pepper we had one farm, now we have another farm and it could be the irrigation. So it could be all the farms that use that irrigation source or water source; correct? Mr. Stenzel. That is what it sounds like to us. I think the FDA panel will obviously be able to answer those questions better than us. Mr. Stupak. OK. Because it is a different farm in Mexico than what the original positive samples back on, what did we say, July 21. And so, OK. Mr. Hubbard, you said you had some, what your understanding is this farm that they had had deplorable conditions, sanitary conditions? Mr. Hubbard. Yes, but again I think conditions in Latin America in produce operations tend to be fairly consistently substandard. And again, the farm knew they were coming and still there were substandard conditions. So one would suspect that perhaps they were even worse earlier. Mr. Stupak. We have inspectors, FDA inspectors in Mexico, do we not, doing produce, looking at the farms? Mr. Hubbard. Usually only for cause. There is not, there is not normally a routine. Mr. Stupak. Not a normal routine inspection going on? Mr. Hubbard. There are lots of attempts to educate though, good agricultural practices, that sort of thing. Mr. Stupak. Mr. Booth, you wanted to say something there? Mr. Booth. Thank you. I just want to make sure that we are not painting a broad brush with Mexico and other Latin American countries that they are substandard. There are many, many exceptional growers in Mexico. We deal with those directly. Mr. Stupak. Right, and I think some testimony was they have a trace-back system---- Mr. Booth. Absolutely. Mr. Stupak [continuing]. In some parts of Mexico. Mr. Booth. Absolutely. Mr. Stupak. Depending on the grower and who they are working with in the United States? Mr. Booth. Yes, sir, that is right. Mr. Stupak. OK. Someone said earlier that a major consumer, let us say like if--who is a major? Jack In The Box, OK, they would have certain requirements for tomatoes which are more towards how they are handled, shipped, grown. Are they different than what you are doing in Florida and California? I mean are you having trouble with corporations saying, do this? You say, well, this is not part of our system. Is that a concern? Mr. Bronson. Mr. Chairman, we are not having a problem because we have one of the highest standards, probably the highest standard in America. So we are not having problem with any of our people who are buying, major corporations that are buying our tomatoes. Mr. Stupak. Well, some of the farmers are telling us that some of the concerns that some of these corporations are putting on them in order to buy their tomato or jalapeno or whatever it is, are things like benzene and things like that that really has nothing to do with the growing of this tomato. And so I just want to see if you get push-back from corporations who are more geared towards risk assessment from an insurance financial point of view as to risk assessment from a food safety point of view? Mr. Bronson. Well, I agree now, now that you have expounded on that, there are certain companies that will say we do not want tomatoes that have a certain product or whatever put on them. And there is usually a third party evaluation of that tomato before that company will buy that particular tomato. Mr. Stupak. Sure. Mr. Bronson. But we have not had problems in Florida. Whatever the standard is we usually can meet it. Mr. Stupak. You think no problem in California like that, Mr. Kawamura? Mr. Kawamura. That is the same. You may know that California provides 50 percent of the fruits, vegetables and nuts that are domestically produced in the United States for the rest of the country. Mr. Stupak. Let me ask this question, if you know. I understand that this type of Salmonella Saintpaul is usually associated with poultry; is that right? Mr. Kawamura. Not necessarily. Mr. Stupak. Not necessarily, OK. OK, Mr. Stenzel, you mentioned something about who was in charge, command center. Can you expound a little bit on that? Should we have, like if you have a natural disaster you have a command center, someone comes in, boom, you know who is in charge, very rigid? Mr. Stenzel. That is precisely the example, Mr. Chairman, that between CDC and FDA in particular throughout this investigation we have noted tension, rivalries, defensiveness between the two positions of individuals within the agencies. We feel that that is an important thing to look at of putting someone clearly in charge. Mr. Stupak. Some kind of an incident command center. Mr. Stenzel. Where CDC fingers the culprit but then FDA is left to investigate it whether they agree with it or not, it is kind of strange. Mr. Stupak. OK. Thank you. Mr. Shimkus. Mr. Shimkus. Thank you, Mr. Chairman. I am going to be brief. As I received the testimony I just want to reiterate we are still looking for this Salmonella-tainted tomato. And once we focused on peppers 18 days to identify the pepper, four days to find the location. And had we identified the right vegetable at the beginning, the losses would have been limited. You still would have had losses. Go ahead, Mr. Bronson. Mr. Bronson. Yes, Congressman, let me say that if we had been given in Florida, and I am sure all the States involved, California including, if we had been given the right information and not withheld information from us we could have gotten to the point very quickly on how to help them in Florida. Every State may be a little different but in Florida if they would have told us what they were looking for, exactly what their suspicions were we could have gone and verified that or denied that we had the problem in Florida which would have cleared it. Now, I hold a commission with FDA, so does Dr. Brown, so does Dr. Aller in our laboratory. But I am not sure what that commission means because I can hear on national news more than what I was being, we were being told at the state level in these conferences. So we cannot help if we do not know what we are supposed to be looking for. Mr. Shimkus. Mr. Brown, you want to answer in response? Mr. Brown. Trace-back works wonderfully and that is an excellent example in the case of the jalapeno. But when you identify the wrong culprit you cannot ever find the trace-back. Mr. Shimkus. Right. And I want to follow-up on this. Because we are going to have a debate about giving the FDA mandatory recall authority. And when this is touched on and also recovery of damages, I am not a lawyer. We have some on the panel. Are any of you all lawyers? What makes a more convincing case, to get cost recovery from a warning or get cost recovery because the government did a mandatory recall that was in error? I have got to believe that we will be on the hook on a mandatory recall, especially when it was in error. And I think that is one of the problems that we might have in this debate as we move forward. I think we all are in agreement, transparency, communication, someone responsible and hold them accountable. I mean I am a military guy, that is kind of the way it works. You have to have a chain of command. And this fusion center we call it in terrorism and connecting the dots, we have heard that numerous times since September 11. We did not do well. The State agencies are getting together where you have people in the same room. That is probably something, Mr. Chairman, we also ought to consider is making sure that we empower everybody to help us solve the case sooner rather than later. And I think we are going to get that in other panels. So with that I really appreciate it, it is a great panel. We have more to come. And I yield back my time. Mr. Stupak. Thank you. Ms. DeGette, have you got some questions? Ms. DeGette. I just have a couple quick questions, Mr. Chairman, thank you. Mr. Stenzel, your industry has endorsed mandatory recall; correct? Mr. Stenzel. Yes, we have. Ms. DeGette. Mr. Beckman, I think your industry has too; correct? Mr. Beckman. Correct. Ms. DeGette. And just so you know, I think most of the industries have endorsed mandatory recall. Most consumers think that we have it now because they read the recall notices and they think they are mandatory. Mr. Beckman, I just wanted to ask you quickly about your document that you flourished during your testimony which is Exhibit 11 in the notebook. That is someone that your organization helped create called Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain. It is my understanding that this document lays out a number of best practices to be used throughout all the levels of the tomato distribution chain, including traceability requirements. Is that correct? Mr. Beckman. That is correct. Ms. DeGette. And it is also my understanding that you believe that national regulations governing the tomato industry should be enacted. Is that correct? Mr. Beckman. That is correct. Ms. DeGette. And if your document Exhibit 11 were used, then the whole tomato industry, not just bits and pieces, would be required to implement comprehensive systems for tracing their products through the supply chain. Is that correct? Mr. Beckman. That is correct. Ms. DeGette. And I also know that the FDA has seen this document. And you would be in favor of the FDA modeling a national regulation based on the contents; is that correct? Mr. Beckman. That is correct. Ms. DeGette. And, Mr. Stenzel, just to clarify with you, I think a lot of what you said is really important and has some nuance that this committee needs to understand. I just want to clarify one thing. Is it the position of your organization that more stringent traceability requirements should be enacted beyond what is currently required in the Bioterrorism Act of 2002? Mr. Stenzel. We believe that with traceability as well as preventive food safety controls they need to be commodity- specific and based on risk. So for the tomato industry we are the co-author of these---- Ms. DeGette. Right. Mr. Stenzel [continuing]. Guidelines and certainly support that in the tomato industry or other products or commodities that FDA would determine to be at higher risk. Ms. DeGette. OK. And you think that those requirements should be more stringent than the Bioterrorism Act of 2002? Mr. Stenzel. We believe that these requirements in the tomato guidelines would be more stringent. Ms. DeGette. And you would support that? Mr. Stenzel. Yes, ma'am. Ms. DeGette. Thank you very much, Mr. Chairman. Mr. Stupak. Thank you. Ms. Schakowsky, any questions? Ms. Schakowsky. No further questions. Mr. Stupak. Well let me thank this panel. It has been most interesting. You have been most helpful. And appreciate your time and your attention to this. And as I said earlier, Mr. Dingell has a bill, most of us are on it, and negotiations are going on between both sides and industry, and hopefully some of the suggestions you made can be part of that. Mr. Shimkus. If the Chairman will yield. Mr. Stupak. Sure. Mr. Shimkus. I will now say that we are also in the room and---- Mr. Stupak. Right. Mr. Shimkus [continuing]. There are negotiations in good faith going on on a bipartisan basis. Mr. Stupak. So hopefully we can get something done here yet this Congress. So thank you very much. We will dismiss the panel. Thank you. [Witnesses excused.] Mr. Stupak. Our second panel of witnesses come forward. One our second panel we have Dr. David Acheson, who is Assistant Commissioner for Food Protection in Food and Drug Administration, also known as the Food Czar; Dr. Lonnie King, who is Director of the National Center for Zoonotic and Vector- Borne, and Enteric Diseases at the Centers for Disease Control and Prevention; Dr. Kirk Smith, who is the Supervisor of Foodborne, Vectorborne, and Zoonotic Disease Unit, Acute Disease Investigation and Control Section at the Minnesota Department of Health; and Dr. Timothy Jones, who is a State Epidemiologist for Communicable and Environmental Disease Services at Tennessee's Department of Health. Welcome, gentlemen. It is the policy of this subcommittee to take all testimony under oath. Please be advised that witnesses have the right under the rules of the House to be advised by counsel during your testimony. Do any of you wish to be represented by counsel during your testimony? [No response.] Mr. Stupak. Everyone is shaking their head no, so I will take that as a no. So therefore I am going to ask you to please rise and raise your right hand to take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect each witness answered in the affirmative. They are now under oath. And we will start with opening statements. If you would like to submit a longer statement for the record we will include it in the hearing record but we try to hold it to 5 minutes. Dr. Acheson, do you want to start, please? STATEMENT OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER FOR FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. Acheson. My pleasure. Good afternoon, Chairman Stupak and members of the subcommittee. I am Dr. David Acheson, Associate Commissioner for Foods at the FDA, which is part of the Department of Health and Human Services. Thank you for the opportunity to discuss the recent food-borne illness outbreak associated with fresh produce contaminated with Salmonella Saintpaul and the measures FDA is taking to enhance the safety of fresh produce and to enhance traceability. There is no question that the Salmonella Saintpaul outbreak investigation has been one of the most complex in recent memory. I assure you that FDA is committed to working with all our food safety partners to expedite trace-backs and to ensure that America's food supply continues to be amongst the safest in the world. For this outbreak alone we are FDA have conducted nearly 450 inspections or investigations together with our State partners. FDA labs have analyzed nearly 450 samples, including samples of produce as well as environmental samples. To support coordination we have hosted or participated in 40 teleconferences with the States as well as CDC. The number of illnesses associated with fresh produce is a continuing concern for FDA and we have worked on a number of initiatives to reduce the presence of pathogens in foods. Some of these activities include working with industry to develop guidance on ways to prevent or minimize potential contamination, conducting educational outreach to consumers on safe food handling practices, sampling and analyzing both domestic and imported produce for pathogens, and working with industry in foreign countries to promote the use of good growing, harvesting, packing, transporting and processing practices. We are also conducting research to improve the identification and detection of disease-causing agents in a variety of foods. I would now like to provide a brief description of a typical trace-back process. CDC along with State and local officials will through its epidemiological investigations identify possible food or foods associated with an outbreak. And at that point CDC notifies FDA. From that point FDA begins our trace-back investigation to identify the source of the contamination. We work with industry and with local, State and Federal officials and, when needed, foreign governments to identify the source of the contaminations. We do this by tracing the food suspected of being the vehicle for transmitting the pathogen back through the supply chain from the retailer or restaurant and inspecting or investigating points throughout that supply chain to determine where the contamination most likely occurred. Tracing food requires us to find and examine documentation such as bills of lading and invoices for the product right throughout the supply chain. We also obtain information on the practices and conditions under which the product was stored and handled at each point. The current outbreak investigation which initially focused on certain types of raw tomatoes provides an example of one of the most difficult kinds of trace-back investigations. It was on May 31 that the CDC advised FDA of the significant statistical association between the consumption of certain types of tomatoes and a multi-state outbreak of Salmonella Saintpaul infections. Raw tomatoes are a perishable commodity and thus are unlikely to be in a consumer's home after a consumer becomes ill, obtains a diagnosis, and the outbreak is identified. Further, raw tomatoes are often sold loose without any form of packaging. In the current investigation we learned that many tomatoes had been shipped to washing, packing and repacking facilities where they were or might have been commingled with other tomatoes from different sources. A further complicating factor was caused by entities in the supply chain using different terminology to describe the tomatoes. Since May 31 many FDA employees in the field and headquarters have been working on the outbreak investigation to identify the source. To help the public distinguish tomatoes not associated with the outbreak, FDA adopted the policy of specifically designating the types of tomatoes implicated in the outbreak as well as listing growing areas that were not part of the outbreak. On July 17 FDA updated its consumer advice, announced that tomatoes currently on the market are not considered to be a possible source of illness. On July 21 FDA announced it had found a genetic match with an outbreak serotype Salmonella Saintpaul in jalapeno peppers we tested from a distribution center in Texas. This finding of a genetic match was an important break in the investigation. Upon further investigation we determined that the contamination of the pepper occurred in Mexico, not at the plant in Texas and, accordingly, on July 25, updated our advisory, announced that there was no indication that domestically grown jalapeno or serrano peppers were implicated in the outbreak. Yesterday FDA laboratory analysis confirmed that both a sample of serrano peppers and a sample of reservoir water used for irrigation contained the Salmonella Saintpaul strain that was a genetic match for the outbreak strain. These samples came from a farm in Mexico but not the same farm that produced the first positive jalapeno samples from the distribution center in Texas. Our current advice is to consumers to avoid jalapeno and serrano peppers grown, harvested or packed in Mexico. In addition, domestically grown raw jalapeno and serrano peppers, canned, pickled and cooked jalapeno and serrano peppers from any and all locations are not connected with this outbreak. We will continue to refine our consumer message as our investigation continues. The current trace-back has worked but was slow, requiring review of many paper records. While sectors of the produce industry may keep electronic records, as we have just heard on the previous panel, and be able to do rapid trace-backs, this is not a uniform practice. And many of the plants FDA visited only had paper records, bills of lading or invoices. To better understand the universe of track and trace systems and best industry practices for traceability FDA has reached out to a variety of external entities. We plan to hold a public meeting in the fall to further exchange of information on available technology and best practices for enhanced traceability. To enhance safety across a range of imported consumer products, last November Secretary Leavitt presented to the President the Action Plan for Import Safety. In conjunction with the Action Plan, FDA released the Food Protection Plan, which provides a framework to identify and counter potential hazards with respect to both domestic and imported food. Both plans build in safety measures across a product's life cycle, from the time a food is produced to the time it is distributed, and encompass the elements of prevention, intervention, and response. The Food Protection Plan identified ten legislative authorities necessary for achieving full implementation. And we appreciate the work this committee is doing to draft legislation intended to help provide these authorities. We look forward to continuing to work with you to develop this important legislation. FDA is working hard to ensure the safety of food, in collaboration with our partners. As a result of this effective collaboration, the American food supply continues to be amongst the safest in the world. However, the Salmonella Saintpaul food-borne illness underscores the challenges that we face. We have been making progress and we are moving forward with the implementation of the plans, but more does need to be done. To that end, FDA is exploring used its Science Board to convene a group of State, industry and academic and other experts to examine lessons learned from the outbreak. I would like to thank you for the opportunity to discuss FDA's continuing efforts to enhance food safety and traceability. And I am happy to answer any questions. Thank you. [The statement of Dr. Acheson follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Dr. King please, if you will. STATEMENT OF LONNIE J. KING, D.V.M., DIRECTOR, NATIONAL CENTER FOR ZOONOTIC, VECTOR-BORNE, AND ENTERIC DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. King. Yes. Good afternoon. Chairman Stupak and members of the committee, thank you for this invitation to address this subcommittee today. I am Dr. Lonnie King, Director of the National Center for Zoonotic, Vector-borne, and Enteric Diseases at the Centers for Disease Control and Prevention. First let me offer my sympathies to all the families who have been adversely affected by this outbreak. Also I understand the frustration of many in the food producing and serving industries who work so very hard to produce safe produce that we have heard about today. CDC leads federal efforts to gather data and to investigate food-borne illnesses. Much of what CDC does depends on the critical relationships with a broad range of partners: food safety regulatory agencies, in particular with FDA and USDA, USDA's Food Safety and Inspection Service, and with State and local public health departments. Salmonella is a group of bacteria with over 2,500 subtypes that is widespread in the intestines of birds, reptiles and mammals. Salmonella is the second most common bacterial cause of food-borne diseases in this country. The current outbreak is called by Salmonella serotype Saintpaul, a relatively uncommon serotype causing only about 1 percent of all reported Salmonella infections each year. This outbreak is the largest food-borne outbreak in the United States in the past decade. This investigation ha been especially complex, difficult and prolonged. CDC first learned about this outbreak on May 22 in 2008 when New Mexico Department of Health reported illnesses in four persons confirmed with Salmonella Saintpaul. New Mexico posted the information about the unusual number of Salmonella Saintpaul cases through PulseNet, a national network of public health and regulatory agency laboratories used to detect food- borne disease outbreaks. This information allowed State laboratories to compare specific DNA fingerprints found in New Mexico to their own cases of Salmonella that had been reported with matching fingerprints. The next day Texas and Colorado reported cases of matching fingerprints. Investigators in New Mexico, Texas and CDC began a multi-state investigation. Epidemiologists conducted in-depth interviews with ill persons to collect information about what might be a possible source of infection. Results of this first series of interviews indicated raw tomatoes were the most commonly consumed food, leading to the hypothesis that they were a possible source of this illness. Following these initial interviews, case control studies comparing what ill and health persons reported eating were then conducted. By May 31 preliminary results of the first case control study showed that the illness was significantly associated with the consumption of raw tomatoes. On June 4 CDC received the first report of a possible cluster or any restaurant cluster and subsequently learned of additional clusters after that. Between June 18 and June 20 there was a large surge in reported cases in Texas. The geographic concentration of illness in the Southwest and in Native American and Hispanic persons, along with a strong association with the consumption of Mexican-style foods in restaurants and the apparent continuation of this outbreak after the alert regarding the tomatoes led to the hypothesis that a food item commonly consumed with tomatoes could also be causing this illness. Investigations then focused on the recently identified clusters and a second multi-state case control study of persons who became ill after June 1 was initiated. The results of the case control study indicated a strong link to fresh produce items used in Mexican cuisine but did not point clearly to one specific item. After additional epidemiologic investigations of a cluster of illness in Texas, the FDA began their trace-backs on peppers on July 21 and the FDA announced that they had isolated the outbreak strain of Salmonella Saintpaul from serrano peppers and water irrigation samples from a farm in Mexico. The outbreak investigation unfortunately continues. The active field investigations by CDC, State and local health departments, focusing on identifying clusters of cases and the FDA trace-backs now on jalapenos, serranos, tomatoes and other possible sources are providing new information daily. This outbreak has been particularly challenging. First, there is inherent delay between when persons become ill with Salmonella infection and when results of the testing are reported to PulseNet. For half the cases in this outbreak it took more than 16 days from illness onset to posting the test results on PulseNet. Second, people have difficulty remembering exactly what foods they ate. And remembering specific ingredients in those foods is even more difficult, especially if the dish was prepared by someone else. Third, the foods in question are often eaten together so exposure to one item often means exposure to all the items. And, finally, perishable foods consumed by ill persons were often not available for testing. As of June 29 at 9:00 p.m., 1,319 cases where Salmonella Saintpaul have been identified in 43 States, the District of Columbia, 255 persons have been hospitalized, and two deaths were possibly linked to this outbreak. At present we believe that jalapeno peppers and serrano peppers are linked to some of these clusters and could be two of several food vehicles, including tomatoes and other possible vehicles, as we continue to explore and investigate. The outbreak is ongoing but there are fortunately fewer illnesses being reported. In conclusion, this outbreak illustrates the importance of existing public health networks: the laboratories performing PulseNet, fingerprinting, epidemiologists who conduct the investigations, the multi-disciplinary approach to these investigations and the close communication and collaboration among State, local and federal officials. We balance the rapid release of information on sources of illness against the potential negative consequences to consumers, food growers, producers and industry. CDC is prepared to continue to work with regulatory agencies, State and local partners, food and environmental microbiologists, and certainly the food industry to find long-term solutions to this challenging problem. I thank you for the invitation to testify and will be happy to answer questions that you may have. [The statement of Dr. King follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Dr. Smith please. STATEMENT OF KIRK SMITH, D.V.M., PH.D., SUPERVISOR, FOODBORNE, VECTORBORNE, AND ZOONOTIC DISEASE UNIT, ACUTE DISEASE INVESTIGATION AND CONTROL SECTION, DEPARTMENT OF HEALTH, STATE OF MINNESOTA Dr. Smith. Good afternoon. Chairman Stupak and members of the subcommittee, my name is Kirk Smith, and I am Supervisor of the Foodborne Diseases Unit at the Minnesota Department of Health. Thank you for inviting me to speak on our role in the Salmonella Saintpaul investigation. We were not highly involved in the national investigation early on. Then, from June 23 through June 27 our State Public Health Laboratory received 10 Salmonella Saintpaul isolates from ill Minnesota residents who had gone to the doctor and been tested for Salmonella at a clinical laboratory. Our foodborne disease epidemiology staff immediately began the process of interviewing these patients. By June 30, several patients had reported eating at the same restaurant. That same day, we visited the restaurant to assess illness in foodworkers, determine the exact ingredients in various menu items, and request credit card receipts to identify other potentially exposed individuals to interview. Ill and non-ill patrons were interviewed in detail about the menu items and ingredients they had consumed. By identifying what ingredients were in each menu item we knew if an individual ate fresh tomatoes, jalapenos, or cilantro, etc., even if they could not discern or recall all of the specific ingredients in a menu item. Then we statistically compared foods eaten by ill people to those eaten by non-ill people. The ingredient-specific analysis indicated that diced jalapenos were the cause of our restaurant outbreak. We sent our preliminary statistics to CDC on July 3, 3 days after we identified the restaurant as the source through patient interviews. Statistics were updated and provided to CDC daily as the scope of our investigation grew. By July 8, 5 days later, we had interviewed 19 restaurant-associated cases and 52 non-ill controls, and unequivocally implicated jalapenos. On our first visit to the restaurant on Jun 30, we also requested vendor invoices for produce items served on the implicated meal dates. Those invoices were given to the Minnesota Department of Agriculture, which conducted trace- backs. On July 3, we provided CDC and FDA with information on the possible sources of the jalapenos, all the way back to farms or distributors in Mexico. This part of the trace-back took 3 days. So why were we able to solve our outbreak so quickly in Minnesota? In short, we have an efficient, rapid, and thorough system. By law, when a clinical laboratory isolates Salmonella or another reportable food-borne bacteria from a patient, the lab is required to submit the isolate to our State Public Health Laboratory. Our lab confirms, serotypes, and DNA fingerprints all Salmonella isolated in real time; and this is not done in many other public health laboratories. There is excellent communication between our lab and epidemiology staff; every day the lab provides us with a report of every isolate they have worked on. Another reason for our success is that food-borne disease investigations in Minnesota are centralized at the State level. We routinely interview all reported Salmonella cases with a detailed questionnaire, and are able to re-interview patients with specific questions quickly as needed. In many other States, Salmonella cases are not routinely interviewed in a timely manner, and if they are, initial interviews are often done at the county level and may not contain sufficient detail. Centralized surveillance and investigations, coordinated at the level of State or large city health departments, are especially critical during multi-state outbreaks due to commercially distributed food items. Food-borne disease surveillance and investigation in the U.S. need to be improved. State and federal funding for these activities in public health departments has decreased throughout this decade, and I believe that this affected the national investigation. State and local health departments need to be able to rapidly confirm and type every Salmonella and E. coli 0157 isolate that is submitted. This is how we can learn that an outbreak is happening as early as possible. But many State public health laboratories cannot currently do this. Secondly, State and local health departments need to be able to rapidly interview every patient with Salmonella and E. coli 0157 with a detailed questionnaire, and to conduct cluster investigations rapidly. Again, this currently is not being done in most localities. As we have heard, the trace-back efforts of federal agencies can only be as good as the quality and timeliness of epidemiologic information coming from State and local health departments. The investment in food-borne disease surveillance will not prevent food contamination from happening, but it will enable outbreaks to be detected and the source identified much earlier. This will help limit the size of outbreaks, minimize the impact on the involved food industry, and identify the types of food products on which to focus our prevention measures. Thank you. [The statement of Dr. Smith follows:] Statement of Kirk Smith Chairman Stupak and Members of the Subcommittee, My name is Kirk Smith, and I am Supervisor of the Foodborne Diseases Unit at the Minnesota Department of Health. Thank you for inviting me to speak on our role in the Salmonella Saintpaul investigation. We were not highly involved in the national investigation early on. Then, from June 23rd through June 27th, our state Public Health Laboratory received 10 Salmonella Saintpaul isolates from ill Minnesota residents who had gone to the doctor and been tested for Salmonella at a clinical laboratory. My foodborne disease epidemiology staff immediately began the process of interviewing these patients. By June 30th, several patients had reported eating at the same restaurant. That same day, we visited the restaurant to assess illness in foodworkers, determine the exact ingredients in various menu items, and request credit card receipts to identify other potentially exposed individuals to interview. Ill and non-ill patrons were interviewed in detail about the menu items and ingredients they had consumed. By identifying what ingredients were in each menu item, we knew if an individual ate fresh tomatoes, jalapenos, or cilantro, etc., even if they couldn't discern or recall all of the specific ingredients in a menu item. Then we statistically compared foods eaten by ill people to those eaten by non-ill people. The ingredient specific analysis indicated that diced jalapenos were the cause of our restaurant outbreak. We sent our preliminary statistics to CDC on July 3rd, 3 days after we identified the restaurant as the source through patient interviews. Statistics were updated and provided to CDC daily as the scope of our investigation grew. By July 8th, 5 days later, we had interviewed 19 restaurant-associated cases and 52 non-ill controls, and unequivocally implicated jalapenos. On our first visit to the restaurant on June 30th, we also requested vendor invoices for produce items served on the implicated meal dates. Those invoices were given to the Minnesota Department of Agriculture, which conducted tracebacks. On July 3rd , we provided CDC and FDA with information on the possible sources of the jalapenos, all the way back to farms or distributors in Mexico. This part of the traceback took 3 days. Why were we able to solve our outbreak so quickly in Minnesota? In short, we have an efficient, rapid, and thorough system. By law, when a clinical laboratory isolates Salmonella or another reportable foodborne bacteria from a patient, the lab is required to submit the isolate to our state Public Health Laboratory. Our lab confirms, serotypes, and DNA fingerprints all Salmonella isolates in real time; this is not done in many other public health laboratories. There is excellent communication between our lab and epidemiology staff; every day the lab provides us with a report of every isolate they have worked on. Another reason for our success is that foodborne disease investigations in Minnesota are centralized at the state level. We routinely interview all reported Salmonella cases with a detailed questionnaire, and are able to re-interview patients with specific questions quickly as needed. In many other states, Salmonella cases are not routinely interviewed in a timely manner, and if they are, initial interviews are often done at the county level and may not contain sufficient detail. Centralized surveillance and investigations, coordinated at the level of state or large city health departments, are especially crucial during multistate outbreaks due to commercially distributed food items. Foodborne disease surveillance and investigation in the U.S. need to be improved. State and federal funding for these activities in public health departments has decreased substantially throughout this decade, and I believe that this affected the national investigation. State and local health departments need to be able to rapidly confirm and type every Salmonella or E. coli O157:H7 isolate that is submitted. This is how we can learn that an outbreak is happening as early as possible. But many state public health laboratories cannot currently do this. Secondly, state and local health departments need to be able to rapidly interview every patient with Salmonella and E. coli O157:H7 with a detailed questionnaire, and to conduct cluster investigations rapidly. Again, this currently is not being done in most localities. The traceback efforts of federal agencies can only be as good as the quality and timeliness of epidemiologic information coming from state and local health departments. The investment in foodborne disease surveillance will not prevent food contamination from happening, but it will enable outbreaks to be detected and the source identified much earlier. This will help limit the size of outbreaks, minimize the impact on the involved food industry, and identify the types of food products on which to focus our prevention measures. Thank you. Summary A restaurant-associated outbreak of Salmonella Saintpaul infections occurred in late June in Minnesota. The outbreak was quickly identified by the Minnesota Department of Health. Diced jalapeno peppers were implicated and traced back to multiple possible sources in Mexico within 3 days of the identification of the outbreak. This information was provided to the CDC and FDA on July 3. This successful investigation was enabled by a strong, centralized foodborne disease surveillance and investigation system at the Minnesota Department of Health, which collaborated closely with the Minnesota Department of Agriculture. The large, nationwide outbreak illustrates that foodborne disease surveillance and investigation activities in the United States need to be improved. Effective investigations by federal regulators depend in large part on the timeliness and quality of epidemiologic information provided by state and local investigators. The Minnesota system could act as a model for foodborne disease surveillance and investigation in the United States. All state and local health departments should be able to confirm, serotype (Salmonella) and DNA fingerprint all submitted Salmonella and E. coli O157 isolates in real time, and they should be able to interview all cases with a detailed questionnaire in real time (this currently cannot be done in most localities). This would help identify outbreaks much more rapidly, which would limit the size of the outbreaks, minimize the impact on the involved food industry, and identify the types of food products on which to focus prevention measures. ---------- Mr. Stupak. Thank you, Dr. Smith. Dr. Jones, your opening statement please, sir. STATEMENT OF TIMOTHY JONES, M.D., STATE EPIDEMIOLOGIST, COMMUNICABLE AND ENVIRONMENTAL DISEASE SERVICES, DEPARTMENT OF HEALTH, STATE OF TENNESSEE Dr. Jones. Mr. Chairman and members of the subcommittee, thank you for the opportunity to be here today. The recent nationwide outbreak of Salmonella associated with produce demonstrates challenges and opportunities for improvement in the nation's food safety infrastructure. A typical American meal includes foods from six different countries, and fresh produce travels a mean of 1,500 miles to get to our plates. Dramatic statistics demonstrate the rapidly changing environment in which outbreaks are occurring. Outbreaks increasingly involve multiple States and widely- distributed products, in part reflecting improvements in detection and investigation. Recent remarkable successes have led to high expectations which realistically cannot be met in all investigations. Epidemiologists, such as those at State and local health departments and CDC, and regulatory agencies, must all work together well for outbreak investigations to be effective. 50 State health departments in the U.S. work under independent public health laws. A handful of States have successfully investigated a disproportionately large number of multi-state outbreaks, reflecting large discrepancies in the resources available to them to respond. Most outbreaks are detected and investigated entirely at the State and local levels. As in the early stages of this Salmonella outbreak, CDC is often in the position of reviewing and integrating results of investigations done by State and local agencies rather than doing de novo investigations. State and local public health epidemiologist frequently interact directly with the public during outbreak investigations, rapidly assessing data to identify the cause. They do not routinely do things like inspect facilities, perform trace-backs, and do recalls. Federal regulatory agencies have very different missions, legal restrictions and relationships with industry. Investigators must constantly balance the risk of continuing disease due to delays in action with the risk of economic damage to the food industry that might be mitigated by waiting for more specific data. And, clearly, it is impossible to meet all of these expectations. Faster product trace-backs would clearly have helped bring this outbreak to a more satisfying conclusion. Many epidemiologists I think view federal regulatory agencies as a black box into which data are sent but from which results are received frustratingly late or never. Federal regulatory agencies often must operate under such restrictive legal constraints that they are unable to share important data such as trace-back information, names of facilities, and brand names as quickly and as fully as many of us would like. In a different outbreak recently, a regulatory agency had information that would have allowed State public health officials to contact consumers at risk of disease but were prohibited from sharing it with us. It is possible for epidemiologists to become commissioned by the FDA to be allowed to receive confidential data, but most of my colleagues have refused to pursue this, specifically to avoid the untenable moral predicament of having access to data which we would then be legally unable to act on. To their credit, USDA and FDA have recently undertaken a number of regulatory interventions based entirely on epidemiologic data prior to laboratory confirmation of pathogens in a food or production facility. And I hope that these recent experiences will not dissuade those agencies from acting rapidly on strong epidemiologic data in the future. My message is not all gloom and doom. Americans today have access to one of the safest, most diverse, and cheapest food supplies in the history of mankind. And a variety of groups, such as the Multi-Agency Council to Improve Foodborne Outbreak Response, or CIFOR, are working toward the common goal of food safety. I think there are a number of opportunities for continued improvement of the nation's food safety infrastructure. Solutions require addressing barriers at the local, State and federal levels. Federal regulatory agencies must have the authority and expectation to share actionable information with public health partners promptly and fully to protect the public's health, and that may require changes in the laws governing them. It is critical to support development of information technology adequate to sustain food safety activities, including improved technology for produce trace-backs, which was available for the recent packaged spinach outbreak, for example, but not necessary for the produce involved in this outbreak. Opportunities for improved coordination with industry should be explored. Industry has access to food testing data and information contained in frequent shopper cards, for example, that is often unavailable to investigators. And, finally, public health agencies are pitifully under funded. Outbreak response capacity, at least at the State level, has been subsidized heavily by funding for successive waves of high-profile crises from bioterrorism to West Nile Virus, SARS and, recently, pandemic influenza. And funding for these is dropping dramatically. Americans eat a billion meals a day, day in and day out, and 75 million of us fall victim to food-borne illness every year. Adequate and consistent funding and resources must be dedicated to sustain effective public health programs commensurate with the true risks that they address. Thank you. [The statement of Dr. Jones follows:] Statement of Timothy Jones Mr. Chairman and Members of the Subcommittee, thank you for the opportunity to be before you today. The recent nationwide outbreak of Salmonella associated with produce, which began in late April, demonstrates challenges and opportunities for improvement in the nation's food safety infrastructure. The global distribution, intensive production, and rapidity of transport of our food supply are markedly increasing the challenges faced during outbreak investigations. A typical American meal includes foods from six different countries, fresh produce travels a mean of 1500 miles to get to our plates, feedlots can hold 300,000 head of cattle, outbreaks involving several hundred victims no longer shock us. a long list of dramatic statistics demonstrate the changing environment in which outbreaks are occurring. Recognized foodborne disease outbreaks increasingly involve multiple states and widely distributed products, including several recent examples associated with fresh produce. Much of this change reflects improvements in the surveillance and investigation of outbreaks, and the capacity of state and local health departments to successfully identify contaminated foods, prevent additional illness, and subsequently make the food supply safer. Such outbreaks also highlight the interdependence of multiple agencies at all levels of government in responding to these events. Epidemiologists (such as those at CDC and state and local health departments), environmental health programs, laboratories, and regulatory agencies (such as FDA, USDA and state Departments of Agriculture) at the local, state and federal level must all communicate well and coordinate activities rapidly for outbreak investigations to be effective. Outbreak investigations typically go through a number of stages, at which various agencies have different levels of involvement. Outbreaks are typically recognized by epidemiologists and laboratories at the state and local levels. Epidemiologists generally work to identify the contaminated food, and regulators then participate in further characterizing the food vehicle and its distribution. Public notification is a critical part of this, at least for outbreaks that may be ongoing, and is usually handled by epidemiologists, regulators or both. It is important to understand that federal agencies (such as the CDC) do not typically initiate investigations of this sort. Thus, CDC is often in the position of reviewing and integrating the results of investigations done by state and local agencies, rather than doing de novo investigations. The outbreak being discussed today has been particularly frustrating for all involved. It demonstrates the complexity of epidemiologic investigations, difficulties inherent in investigations of novel foods not typically implicated, statistical limitations in identifying one food item which is commonly consumed with other foods (salsa for example), inherent complexities of tracebacks of fresh produce, and challenges in public communication. Recent remarkable successes in investigations of spinach and lettuce-associated outbreaks and a number of other widely distributed products have led to high expectations which realistically can't be met in all investigations. There are important differences in the ``cultures'' of the many different agencies that must work together in investigating outbreaks, with widely disparate missions, mandates, legal authorities, and organizational structures. While these are generalizations, state and local public health epidemiologists frequently interact directly with the public during outbreak investigations, rapidly assessing data to allow identification of the cause of an outbreak and make recommendations for preventing additional disease. Federal epidemiologists typically collate information from multiple states, but may not if there are only a few involved. CDC is generally called upon to assess epidemiologic data before federal regulatory agencies will act. Epidemiologists do not routinely do things like inspect facilities, perform tracebacks, or do product recalls. Epidemiologic, laboratory and environmental data are used to inform regulatory agencies, such as the FDA and USDA, in carrying out their functions. These federal agencies have very different responsibilities, priorities, relationships with industry, and legal mandates and restrictions. Because of the very different ``cultures'' and working environments of these groups, widely varying perspectives on the challenges and weaknesses in outbreak investigations are inevitable. Consumers might be expected to desire immediate intervention to prevent potential disease, erring on the side of caution by acting on data that may be quite preliminary. On the other hand, many food producers would not want to see their business suffer because of poorly substantiated suspicions, and would expect public intervention to occur only on the basis of comparatively definitive data. Investigating agencies must constantly balance the risk that delays in action might lead to additional preventable disease, with the risk of economic damage to large sectors of the food industry that might be mitigated by waiting for more specific data. Clearly it is impossible to satisfactorily meet all of these demands and expectations, and every outbreak requires making judgments based on unique circumstances and data, quickly and under great pressure. While there may be room for improvement, it is important to acknowledge that there are no rules, policies, or legal or administrative interventions which will obviate the need for difficult human decision-making in these situations. Moreover, it is important to realize that these decisions are not made by a single federal agency. States can and do act independently when ongoing risks are suspected, though it would be rare for that to happen without notification and consultation with federal agencies, particularly for products that are distributed across state lines. In addition, communication with industry may occur at the state or federal level. There are over 3000 local health departments in this country, and 50 state health departments working under 50 independent sets of public health laws. Not unexpectedly, there is tremendous variability in the capacity to respond to disease outbreaks among different jurisdictions. A cursory review of outbreaks in recent years will demonstrate that a small handful of states appear to have successfully investigated a disproportionately large number of multi-state outbreaks. This is not an accident, and it is highly unlikely that those states really have more disease than others. Rather, this reflects discrepancies in the resources available, as well as the capacity and inclination to detect and investigate outbreaks. CDC does not in most cases have jurisdiction to come into states and investigate outbreaks without invitation. The large majority of outbreaks are detected and investigated entirely at the local and state levels, without any need for federal agency involvement. State health departments of course have very different thresholds for consulting with federal partners and requesting their assistance. In this recent Salmonella outbreak, for example, the initial disease clusters were recognized and investigated by local and state public health authorities. As the scope of the outbreak grew, CDC was invited in, initially to help evaluate data already collected by other agencies, and subsequently to become increasingly involved in designing and directing the investigations. Likewise, the FDA became progressively more deeply involved as the investigation evolved. At all stages in this fluid continuum, participants are necessarily dependent on data already collected by others previously, and must wait as additional data are collected, which invariably takes more time than any of us would like. I think that it is safe to say that many public health epidemiologists view regulatory agencies such as the FDA and USDA as a ``black box'', into which data are sent, but from which results are received frustratingly late, or never. There are many examples of situations in which state health departments have proceeded with their own product testing or limited tracebacks, and gathered important data long before information was available from the federal regulatory agency involved in the investigation. I don't believe that these agencies are purposely withholding critical information from public health partners, but I do think that they are required to operate under such restrictive legal constraints that they are unable or unwilling to share data as fully and as quickly as we would all like, even in urgent situations. Federal regulatory agencies are frequently prohibited from sharing proprietary information and ``trade secrets'' obtained during the course of their investigations, which can include names of facilities, suppliers, traceback information, brand names, etc. I also acknowledge that tracebacks and regulatory investigations are far more time-consuming and complex than many epidemiologists appreciate, and our expectations of prompt results from an understaffed, underfunded and overworked agency are unrealistic. All that being said, I think it is inarguable that faster product tracebacks and better communication would have helped bring this outbreak to a more prompt and satisfying conclusion. In order for this to be possible, however, investigating agencies must have adequate resources to get the work done, and the legal authority to collect and share their data promptly and appropriately. I was recently involved in another outbreak which highlights similar limitations. During the investigation of a contaminated product under the FDA's jurisdiction, investigators in that agency had information in their possession that would have allowed state public health officials to quickly identify and contact consumers at risk of serious disease. However, because of policies restricting sharing of proprietary data and information collected through related mechanisms, they were prohibited from sharing it with us. The situation was as frustrating for the FDA personnel involved as it was for us, but we find these types of restrictions during outbreak investigations unconscionable. Of note, it is possible for public health epidemiologists to become ``commissioned'' by the FDA to be allowed to receive confidential data such as those to which I just referred. Most of my colleagues have refused to pursue this, expressly to avoid the untenable moral predicament of having access to data which they would be legally unable to act upon. To their credit, it is notable that both FDA and USDA have undertaken tracebacks and regulatory interventions in a number of recent outbreaks, based entirely on epidemiologic data, without first having laboratory confirmation of pathogens in a food or production facility. This has not been the norm in the past, and this growing acceptance of epidemiologic data has led to much prompter interventions to stop outbreaks and prevent additional disease. Clearly, careful consideration of the weight and implications of all data is critical, but I hope that the experience of the outbreak currently under discussion will not dissuade these federal agencies from acting rapidly on strong epidemiological data in the future to protect the public health. Suspected produce-associated outbreaks are particularly difficult to investigate, from both the public health and regulatory perspectives. Typical produce items pass through a myriad of hands along the ``farm to fork'' continuum. While large food service corporations and their suppliers often have excellent quality-control programs with impeccable records, many other companies don't, and product tracebacks are susceptible to complete breakdown at the weakest link in the chain. Produce is generally purchased by consumers unlabeled, with no information on its origin. Produce from more than one source is often mixed at different distribution points. Many consumers have difficulty identifying subtle differences in varieties of produce. Such items are frequently consumed as ingredients in other foods (salsa, for example), or in foodservice establishments where consumers can't know a food's origin, and may not even be aware of what they are eating. Even if very detailed information from victims can be supplied by public health investigators to a regulatory agency (which is frustratingly difficult in and of itself), the challenges to performing subsequent tracebacks through such a complex food- handling chain are formidable. It is important to delineate the jurisdiction and responsibilities of various agencies during outbreak investigations. Food safety is reportedly overseen by 14 federal entities, administering over 35 separate food safety laws, with the involvement of 28 congressional committees. That open-faced sandwiches are regulated by one agency and closed- faced sandwiches another, or jurisdiction differs based on whether a product contains more or less than 2% meat, can be complicated. I have been involved in outbreak investigations in which both FDA and USDA had regulatory authorities within the same production plant, and indeed the same production line, depending on the type of food topping being used that day, and each agency has strikingly different regulatory policies. A substantial underlying cause of many of the problems I have described is a limitation of resources available to agencies responsible for responding to foodborne outbreaks. We are all familiar with the dramatic statistics describing the FDA's understaffing and responsibilities far exceeding their capacity to meet them, including the fact that only 50 staff are dedicated to inspecting all imported foods, and well under 1% of these products undergoes even cursory examination. CDC suffers from similar underfunding. More than one outbreak was occurring at this time, as is usually the case. Even with excellent staff, the agency simply cannot do its job if overtaxed. State and local public health agencies are likewise pitifully underfunded. Although the front line in outbreak investigations is at the state and local levels, most of those agencies receive the large majority of their funding from federal grants. Our outbreak-response capacity is in large part supported by funding granted for successive waves of high-profile crises, from bioterrorism and anthrax, to West Nile virus, followed by SARS, then pandemic influenza. These resources have subsidized a wide array of core public health functions, notably disease surveillance and outbreak investigation activities, which otherwise would be impossible to sustain. In recent years ``preparedness'' funding has been cut repeatedly, leading not only to the obvious direct effects, but also to adverse impacts on our capacity to respond to events like foodborne disease outbreaks, which do not usually attract national attention but occur daily and affect millions of Americans annually. I obviously recognize the importance of disaster preparedness, but also believe that we need to realistically apportion resources to address public health threats in a logical manner. When the ``red phone'' rings for a bioterrorism attack it is important that we be prepared to respond, but while the likelihood of such an event is impossible to measure, Americans eat a billion meals a day, day in and day out, and 75 million of us fall victim to foodborne disease every year. My message is not all ``gloom and doom''. Americans today have access to one of the safest, most diverse and inexpensive food supplies in the history of mankind. Public health, regulatory agencies and industry work remarkably well together toward the common goal of food safety. Huge strides are being made in our capacity to identify, respond to and prevent foodborne disease. FoodNet, a cooperative program among 10 states, the Centers for Disease Control and Prevention, USDA's Food Safety and Inspection Service, and FDA's Center for Food Science and Nutrition, performs internationally-recognized studies of a wide variety of foodborne disease issues. PulseNet, a CDC-based system for sharing of molecular ``fingerprinting'' data from foodborne pathogens with a variety of agencies has markedly improved disease surveillance and rapid recognition of foodborne outbreaks. OutbreakNet is a CDC- coordinated group of foodborne disease epidemiologists from all 50 states, as well as representatives from other food safety agencies, that is focused on ways to improve communication and response to outbreaks. Outbreak-response training programs are available, including Epi-Ready, which is a national effort to bring environmental health, laboratory, regulatory and epidemiology personnel together for coordinated training. The Food Safety Research Consortium is a non-governmental organization pursuing a variety of projects including a recent report, ``Harnessing Knowledge to Ensure Food Safety: Opportunities to Improve the Nation's Food Safety Information Infrastructure''. A variety of other academic, consumer- advocacy and industry groups are engaged in similarly important efforts to address many of the issues that have been discussed today. The Council to Improve Foodborne Outbreak Response (CIFOR) is another important example of successful efforts to address barriers in the food safety infrastructure. CIFOR is a multidisciplinary working group convened in 2006 to increase collaboration among the various public health agencies involved in the investigation, control and prevention of foodborne illness. The Council of State and Territorial Epidemiologists (CSTE) and the National Association of County and City Health Officials (NACCHO) are co-chairing CIFOR with support from the Centers for Disease Control and Prevention (CDC). Epidemiology, laboratory, environmental health and regulatory agencies at the local, state and federal levels are represented. CIFOR is now exploring ways to increase involvement of industry representatives appropriately into its activities. Recent CIFOR projects have included establishment of an online clearinghouse of foodborne-disease response resources, development of guidelines for responding to multi-jurisdictional outbreaks, development of performance indicators for assessment of outbreak-response programs, and writing comprehensive guidelines for multi-agency investigations of foodborne disease outbreaks. I believe that there are a number of opportunities for continued improvement of the Nation's food safety infrastructure: -Adequate and consistent funding and resources must be dedicated explicitly to sustain effective public health and food safety programs, commensurate with the true risks associated with the public health threats they address. -Federal regulatory agencies must have the authority and expectation to share actionable information with public health partners promptly and fully, to the extent necessary to protect the public's health. This may require changes in laws governing those agencies, and trust among public health partners and industry that sensitive and propriety information will be used only for protection of the public's health. -Though I do not believe that federal public health epidemiology programs should be merged administratively with federal regulatory agencies, there is great potential benefit to reviewing jurisdiction of food types, facilitating improved communication among these agencies, including developing mutually accessible databases, ensuring rapid sharing of data during public health emergencies, and continuing to develop inter-agency training opportunities. -It is critical to support development of information technology adequate to sustain outbreak detection and response activities. This includes resources for the development of state-based disease surveillance databases that both serve state needs and that allow for the sharing of essential information with other states and federal agencies, electronic laboratory reporting from commercial laboratories to public health agencies, and open data standards that allow data sharing among all food safety and public health agencies. -Opportunities for improved coordination with food industries should be explored. Many food industries conduct testing which could be valuable in identifying the sources and causes of foodborne illness and outbreaks. Data sharing by industry should be encouraged. In addition, while outbreak investigators require appropriate independence, the food industry has access to data that can be important to investigations. One example is the detailed information often contained in ``frequent shopper cards'', which can include contact information and precise data on dates and products purchased. A limited number of stores have been very cooperative in sharing such data with public health investigators, but unfortunately this is not currently the norm. Many grocery chains enter into contracts with consumers that they interpret to prohibit unilateral disclosure of sales information to public health agencies. In summary, I believe that our nation's food safety infrastructure is strong, but substantial barriers to continued improvement remain. Important strides are being made to improve foodborne disease outbreak response, and with adequate support there are many additional opportunities for improvement. I applaud today's meeting as recognition of the importance of pursuing these goals. Thank you for the opportunity to discuss these issues with you today. Summary -Improving the nation's food safety infrastructure, and capacity to respond to outbreaks, will require addressing barriers in epidemiology, laboratory, environmental health and regulatory agencies, at the local, state and federal levels. -Adequate and consistent funding and resources must be dedicated explicitly to sustain effective public health and food safety programs, commensurate with the true risks associated with the public health threats they address. -Federal regulatory agencies must have the authority and expectation to share actionable information with public health partners promptly and fully, to the extent necessary to protect the public's health. -Formal mechanisms to facilitate effective communication, sharing of data, and inter-agency training among agencies, and with industry, should be developed. -An adequate information technology infrastructure is critical to ensuring successful outbreak responses. -Mechanisms should be developed to support and take maximum advantage of successful efforts, including those of non- governmental, academic, consumer and industry organizations, to improve the food safety infrastructure. ---------- Mr. Stupak. Well, thank you. And thank you all for your testimonies. Now we will begin questions. Dr. Acheson, I have been talking about these 3 releases in the last 12 hours because I think it adds more confusion as to what was going on. The first one 9:00 o'clock last night was on jalapenos. The one at 10:15 I think or 10:30 was on cilantro. And then the one today sort of expands and talks a little bit about this farm and the location down there in Mexico. And one of the questions I asked the other one is, the other panel was you still have not cleared the tomatoes. Are tomatoes still a suspect or vegetable of interest as we were calling it on the first panel or are they cleared now? Dr. Acheson. FDA has investigated tomatoes. We have done a lot of testing with States and other federal agencies. We have not found a positive sample. We have inspected farms and---- Mr. Stupak. So why do you not clear the tomato? Dr. Acheson. At this point there is nothing for FDA to say that would indicate the evidence that CDC and the States generated early on in this investigation is incorrect. FDA based on that information did its trace-back. Mr. Stupak. Right. Dr. Acheson. And it is not up to FDA to say that that original case control study was---- Mr. Stupak. Well, then who clears the tomato then? If it is not up to the FDA you have no Saintpaul Salmonella or Salmonella Saintpaul in any tomato product. We have cilantro suspect and now we have peppers for sure; right? Dr. Acheson. Right. Correct. Mr. Stupak. Well, so who would clear it then I mean? Dr. Acheson. We have made it very clear that there are no tomatoes that are currently available on the market from anywhere in the world that are linked to the outbreak. Mr. Stupak. Currently. But how about tomatoes from the original suspect? That is what the last panel was concerned about, that that hangover effect still exists as to tomatoes. Dr. Acheson. Are you suggesting that FDA go back and say that that original conclusion was incorrect? Because that is not FDA's role. FDA picks this up at the point---- Mr. Stupak. OK, so if the FDA makes a mistake you never say, I might have made a mistake? Dr. Acheson. Of course we would. But we did not make a mistake. FDA---- Mr. Stupak. How do you get Saintpaul Salmonella with the tomato then. Dr. Acheson. Let me try this again. Mr. Stupak. Yes. Dr. Acheson. FDA begins its trace-back---- Mr. Stupak. Correct. Dr. Acheson [continuing]. Based on information---- Mr. Stupak. From the CDC and others, right. Dr. Acheson. Right. Mr. Stupak. All right. Dr. Acheson. We do that in good faith based on the science---- Mr. Stupak. Right. Dr. Acheson [continuing]. That CDC has undertaken. Mr. Stupak. And in your trace-back you found nothing to implicate the tomato? Dr. Acheson. And we have said that. And we have said that tomatoes that are currently on the market are safe to consume. Mr. Stupak. On behalf of the tomato, they want their good name back, I think you should put out something a little more firmer on that. Let me ask you this. These farms in Mexico that you now suspect with the jalapenos---- Dr. Acheson. Yes. Mr. Stupak [continuing]. Do any of them grow tomatoes? Dr. Acheson. Yes, they do. There is at least one farm. Mr. Stupak. OK, at least one. Then the irrigation water that is suspect is that irrigation water being used on tomatoes then? Dr. Acheson. The farm that grows tomatoes also grows serrano and jalapeno peppers. Mr. Stupak. OK. Dr. Acheson. That is the farm where the original peppers that were positive in McAllen, Texas, traced back to. Mr. Stupak. OK. That's the one that Minnesota had; right? No? Dr. Acheson. That is, the Minnesota part is just one piece of this. Mr. Stupak. OK. OK. So the farm, there is at least one farm in Mexico that grows jalapenos and tomatoes that we have positive for Salmonella Saintpaul; correct? Dr. Acheson. Let me try this again. There is---- Mr. Stupak. If I am confused the American people are really confused. Dr. Acheson. FDA found a positive sample of jalapeno peppers at a distribution center in Texas. Mr. Stupak. Texas. Dr. Acheson. OK. Mr. Stupak. You traced it back to a farm in---- Dr. Acheson. We traced--can I finish? Mr. Stupak. Sure. Dr. Acheson. That may clarify your confusion. We traced that positive sample of jalapeno peppers back to a farm in Mexico. That farm grows jalapenos, serranos and tomatoes. Mr. Stupak. Tomatoes, OK. Dr. Acheson. As part of the investigation in Mexico we were investigating other farms and we took samples on other farms. Mr. Stupak. Correct. Dr. Acheson. And found the outbreak strain on a different farm that grows jalapeno peppers and serrano peppers but does not grow tomatoes. Mr. Stupak. OK. Dr. Acheson. Now one question that is out there, which I think you are getting at is, is there a connection between those two farms? Mr. Stupak. Well, where is the water source coming from? Dr. Acheson. That is a good question and that is part of what we would try to determine while we are there. Mr. Stupak. Would these two farms use the same water source? Dr. Acheson. Do not know. Do not know. But what I can tell you is that those two farms do send their produce through a single distribution center. Mr. Stupak. How far apart are these farms? Dr. Acheson. I believe they are about 3 hours drive but I do not know specifically how many miles apart they are. Mr. Stupak. OK. Then let me ask this question I asked of the previous panel and they were not real clear on it or did not quite: is Salmonella Saintpaul usually associated with poultry? Dr. Acheson. Salmonella, yes, typically with turkey. Mr. Stupak. Turkey? Dr. Acheson. Yes. Mr. Stupak. OK. Are there turkey farms down there near this area in Mexico? Dr. Acheson. Not aware of any turkey farms down there. Mr. Stupak. OK. Let me ask this: any reason why you could not clear domestically grown tomatoes then? Dr. Acheson. We have already stated that domestically grown tomatoes, tomatoes from anywhere are perfectly OK to consume. Mr. Stupak. OK, let me ask you this. Let me go to Dr. Smith. You said, and I am going to come right back to you, you said when you did the jalapeno and you nailed it there you traced it back to the farms in Mexico? Dr. Smith. There were multiple possible sources of these jalapenos and they were all in Mexico. Mr. Stupak. OK. I am sure you gave that information to the FDA. Dr. Smith. Yes. Mr. Stupak. So are we talking about the same farms then that Minnesota suspected? Dr. Acheson. Yes. They crossed into our systems, into what we were tracing back. Mr. Stupak. OK. How many farms or possible sources did you find? Dr. Smith. Well, we could not get back all the way to the farm level. Mr. Stupak. OK. Dr. Smith. All of the farms. But we had three different possible trace-back farms. Mr. Stupak. OK. Dr. Smith. And they all went back to Mexico and one of them only could we get back to a distributor. Mr. Stupak. OK. So you found these three farms you have at least two farms about 3 hours apart and the water source we are still not sure about yet; right? Is that correct, Dr. Acheson? Dr. Acheson. We found two farms, yes, but we have been-- there are many other farm distribution centers that have crossed over in this trace-back. It is not as simple as just two farms in a distribution center. Mr. Stupak. OK. How many, if you know, how many farms use this water source that has suspect with Salmonella Saintpaul? Dr. Acheson. I do not know. Mr. Stupak. OK. OK. Let me ask this question. You mentioned you are going to have a fall conference, Secretary Leavitt has called a fall conference. Will the FDA be running a post-mortem on what went right, what went wrong on this recall? Will you be doing that? Dr. Acheson. We are proposing two things: one is a public meeting in the fall that will be focused on issues around traceability. We have had a lot of discussion earlier, it is very important. Mr. Stupak. OK. Dr. Acheson. What I said is that right now we are exploring using our Science Board as a mechanism to set up a subcommittee of the Science Board that could involve industry, State, federal, academic experts to help---- Mr. Stupak. Right. Dr. Acheson [continuing]. Ask questions about what can we do better? What went wrong? What are the lessons learned? Mr. Stupak. Why would you not just use the folks involved in this one because this one is the largest Salmonella outbreak we have had in the last 10 years, last decade? Why would you not use the folks in the first panel to help do it as proposed? Dr. Acheson. We very well may. It just needs to be done through the mechanisms of the Science Board. As you have raised earlier or has been raised in terms of information that we can share and the Federal Advisory Committee Act, laws that are around, discussions, etc., it has to be done according to the law. Mr. Stupak. Right. Dr. Acheson. And doing it through the Science Board is a process that allows us to do that. Mr. Stupak. OK. Dr. Acheson. The experts---- Mr. Stupak. OK, last Science Board on review in the FDA though and the things you had there it was limited to they could not talk about budget, so I would hope that this Science Board would be given full review of the information so they can put forth recommendations to help assist with this. Let me ask you this, with any crisis you learn from your weaknesses in the existing system. What have you learned from this investigation that requires legislative changes? Because in your testimony you said Congress is drafting. We are past drafting, we are actually negotiating between all the parties, and I know the FDA has been involved. So and we are getting, we are on the food part right now on food safety. So what legislative changes have you learned that we need to help you with this kind of investigation? Dr. Acheson. Of the 10 legislative proposals that we have discussed previously as part of the Food Protection Plan, probably the one that is most important is the one that requires preventative controls. I do not think anybody would disagree that the key answer to this is not to react faster but is to prevent the problems in the first place. That is absolutely critical across the board. So that is a very important one. There are other components in there in terms of the other legislative proposals that would help somewhat. Another one, for example, is the requirement for certification for certain imported products. That is a federal to federal agreement. But that is another example that could help us. And then I think as the questions around lessons learned unfold here, and we are still focusing on stopping the outbreak as opposed to focusing on what are the lessons learned after, but obviously there needs to be lessons learned and discussion around traceability and whether there needs---- Mr. Stupak. Right. Dr. Acheson [continuing]. To be a legislative fix around that. Mr. Stupak. Well, we had the Bioterrorism Act of 2002 which was supposed to give the Secretary of HHS the tools necessary to have rapid trace-back of a food commodity through a distribution chain. Did the Bioterrorism Act work here? Dr. Acheson. The Bioterrorism Act worked as written. We rarely ran into a problem where people were not keeping records of people who were supposed to. That did not slow it down. Contrary to what you heard on the first panel, what we learned in this outbreak is that it was many of the small producers, the small restaurants, much like Mr. Shimkus' example of the little restaurant that he goes to on a Friday night that were involved in this, they do not have electronic systems. The vast majority of the information we got was paper, it was invoices, it was bills of lading. That has to be worked through by a person just working their way through, looking for the connectivity. Mr. Stupak. Should not the farm be included in the Bioterrorism Act? Right now it is exempt, farms and restaurants. Would that not have really helped you out if they were part of the Bioterrorism Act? Dr. Acheson. Currently the Bioterrorism Act does not cover you from farm---- Mr. Stupak. Right. Dr. Acheson [continuing]. All the way through to restaurant. Mr. Stupak. Right. Should they not be included? Dr. Acheson. It certainly would expedite the process if they were. Mr. Stupak. OK, let me go to Dr. Smith, I have a question or two. I read from an Associated Press article, and I want to go back to that, on July 23 Associated Press ran an article entitled, and I am quoting, ``A Hot Lead in the Hunt of Salmonella Source: Minnesota Pinpointed jalapenos While Feds Fruitlessly Chased Tomatoes.'' I presume you have read this article? Dr. Smith. Yes. Mr. Stupak. OK, then let me ask you this. The article suggests that the State of Minnesota was using certain outbreak investigation techniques that the CDC and FDA were not using. Are there certain things that you believe that the State of Minnesota did in this outbreak that key federal agencies did not do? Dr. Smith. Well, first of all I should say you know the types of things that we do are the types of things that need to be done in other State and local health departments. Mr. Stupak. Right. But what about CDC and FDA, should they be using those things too? And what are they? Dr. Smith. Well, OK, so what makes I think us so successful is that our laboratory confirms and types all Salmonella isolates that they get right away. It takes 2 or 3 days. And then they give that information to epidemiologists right away. And then we interview these patients right away. Mr. Stupak. So that the rapid response from the investigation of the slide to your local health to the interviews? Dr. Smith. I think it is the rapid response. But it is also the level of response. We get very detailed information from all of these patients. And I also have epidemiologists who work only on food-borne disease. They are evaluating clusters every day and so they are very experienced. Mr. Stupak. So in the first panel when they said, well, yesterday I was working on heart stents, today I am working on tomatoes, that does not lead to good investigative work? Dr. Smith. Yes, certainly it is better if you have got people that are just dedicated and focused on one thing. And we are fortunate to have enough resources to be able to have epidemiologists that are dedicated to food-borne disease. And a lot of these resources are from federal programs such as Food Net. Mr. Stupak. OK. Just one last question before I turn to Mr. Shimkus. Dr. Acheson, it came up in the first panel, it sort of came up here, Dr. Jones mentioned it, if this were bio- terrorism how would you have acted differently? Dr. Acheson. If this was deliberate the process would have been the same. Mr. Stupak. So even information sharing would have been the same? There has been complaints about information sharing and whether a person would be commissioned or non-commissioned because there is a concern about information sharing. No command, incident command center, no one was in charge was the other allegation. So you would handle it the same? That is not a good idea. Dr. Acheson. There was a lot of information sharing that went on, a lot of work was done. In fact, with the State of Florida, as Commissioner Bronson talked about, we did use Florida labs, we did use Florida inspectors when we were down in Florida. So we actually did what he was suggesting that we did not do. Mr. Stupak. But Florida is mad at you for banning their tomatoes when they could provide traceability with a system that FDA helped develop. So I do not think Florida is especially happy with the FDA or the way information was shared. Their traceability would have showed because of the outbreaks that---- Dr. Acheson. I am pointing out that we did share a lot of information with Florida and we did use the Florida resources, as the Commissioner suggested we should. We did, we used their labs and we used their inspectors. Mr. Stupak. Well, I hope if we suspect a bio-terrorism we are not going to treat it the same way, that there would be a little bit more urgency to it. Dr. Acheson. The trace-back process would be the same. It is what it is. Mr. Stupak. So then it is a major hole in our national safety, whether it is bio-terrorism or Salmonella Saintpaul? Dr. Acheson. If somebody has done something deliberate that is involving the same type of products in the same type of restaurants and retailers it would be no different, it could not be different. It is still right now paper, invoices, bills of lading. You have to go and get them, you have to go and pick them up. That is what could be a focus of making it faster if there was a deliberate act. Now, obviously if this was deliberate there would be different federal authorities involved. Homeland Security would have a lead if it was a bio-terrorism event. It would be run differently. I am simply focusing on FDA's role with the traceability. It is what it is. I mean and it worked, it was just slow. Mr. Stupak. Mr. Shimkus please. Mr. Shimkus. Thank you, Mr. Chairman. I want to go back. I think we are pounding on FDA but FDA spent all this time going after the wrong suspect because it was not identified properly to begin with. And once we got identification with the help of a public health department, 18 days plus 4 to find the location. And so I think there are ways that we think we can make things better. And my questions are going to be in that. But we have got to keep this in focus. I think the original panel identified that. We just got taken off in the wrong direction and the FDA went. Traceability worked, maybe not as quickly as would like, but it worked. And the reality is, Diana, the reality is tomatoes first time for this disease is infinity. We are still looking, we cannot find it. When it was identified in peppers, 18 days to find the pepper, 4 days to find the location. I think that is a success. What went wrong was that and the issue is the CDC and the public health department. So I would like to ask first, we have two public health departments, how big is the State of Minnesota population-wise? Dr. Smith. About 5 million people. Mr. Shimkus. And, sir, your state? Dr. Jones. Six million. Mr. Shimkus. And so what is the budget, Dr. Smith, of yours, of the State Public Health Department? Dr. Smith. I basically have one food-borne disease epidemiologist for every million people in the State. Mr. Shimkus. One for every million. And, Dr. Jones? Dr. Jones. Same order of magnitude, yes. Mr. Shimkus. And we do not have to name States, but you probably know States that have one epidemiologist for how many? Dr. Smith. Every 24 million people. Mr. Shimkus. Twenty-four million. And I guess Texas, I mean and we are talking about this starting in Texas or New Mexico. I guess Texas was the second point. And I do not want to even ask about my State. So but if we had a bio-terrorism attack it would be identified first by who? Dr. Smith. It would be identified in exactly the same way as a natural contamination would, exactly. Mr. Shimkus. And it would go once you had identified the convergence, the commodity, you would then go to the CDC? Dr. Smith. Absolutely. Mr. Shimkus. And then in conjunction we would then have to raise a concern to start finding where this thing started from. And again, if we are using this as a case study we just identified it wrong. So I think part of this debate is public health, public health departments get them funded, get them technologically advanced. And then probably, Dr. King, probably working with CDC to get you all fully funded and up to speed and staffing, would you not agree? Dr. King. I certainly agree that many of the states are under-resourced when it comes to many public health problems, including food safety. I think that was one of the inherent problems and lessons learned here is that they were poorly resourced and could not respond just because they did not have the resources to put into this. When you talk about, Congressman, about the States talking to CDC, there is a system in place called PulseNet. And PulseNet is in place. All the States have PulseNet capabilities. There are counties and cities that also have PulseNet. So concurrently and simultaneously we can through the States, local and CDC actually look across the 50 States and even further into those States, into cities, with a system that is standardized to say, oh, this is Salmonella Saintpaul, this is the variety that has caused outbreak over New Mexico and Texas and Illinois. That gives us then the capability to say this is a multi-state outbreak. There is a source here that we did not know about. The CDC's role then--and by the way, the States can look at this just as quickly as CDC can--CDC then is involved in that coordination when asked. Last year there was 1,260, right, outbreaks that came to CDC's notice. Of those, about 120 CDC was actually involved in giving advice, helping where asked. 12 of those we actually took a lead role. 90 percent of what is happening in the food safety area is at the local and State level. 1 percent of the time CDC actually gets involved in a lead situation. That is why these States need to have proper resources. Mr. Shimkus. And I mean this is a tough position because you make a call, there are people ill. Make the wrong call then you have got the culprit still out there. People are sick, people are dying. It is an honorable profession and we applaud your work, we are just trying to get it better. Dr. Jones, and this is also in preparation for the hearing, I want to know what are the barriers, these legal barriers, and I want to know some specifics of what are the legal barriers that are limiting our ability to more quickly, clearly identify culprits and the like? Do you have any that you can specifically give me? Dr. Jones. I am not aware of any legal barriers to sharing epidemiologic data. And I think that that occurs quite rapidly in both directions and goes to the regulatory agencies fairly quickly. I guess the examples that I am familiar with have to do, and again I am not an attorney, have to do with legal restrictions on federal regulatory agencies not being able to share potentially, you know, proprietary information. Mr. Shimkus. Yes, give me an example. We want to, I would think the committee would want to find out exactly what those are. And as we are doing legislation to say when there is a national public health risk we have to tear these down and we have to ensure that the federal agencies protect the propriety while we are finding information. So, Mr. Chairman, as we continue this I think this is a key area. And I mean does anyone, can anyone share? Dr. Acheson? Dr. Acheson. Part of the problem here is proprietary information that is deemed to be commercial confidential. There is a mechanism through commissioned individuals at the State level that that can be shared with. And we---- Mr. Shimkus. Well, we heard about commissioned individuals---- Dr. Acheson. Yes. Mr. Shimkus [continuing]. In the first panel. And they did not seem to have much power or control or input. Dr. Acheson. No, we are able to share information with commissioned individuals, and we do. And I think to that point if a commissioned individual in a State is saying, we think there is something going on and we would like some information, nothing to stop them picking up the phone and saying, can you help us here because we have some questions, if they are commissioned. Mr. Shimkus. Well, we are going to, I know on our side we are going to try to dig in, Mr. Chairman, on this issue because we are the legislative branch. You know, we can--Dr. King, do you want to add? Dr. King. There is one piece of information I know the industry was hoping to get and could not get and was critical of it, and that was identification of cases by county. And that is something that through our legal counsel when a State shares information with us first of all the data and information is the State's. When it is shared voluntarily with CDC it becomes part of the federal record. It is also then under the authority of Privacy Act and also under Freedom of Information Act and agency policy. And it has been consistent and the recommendation of our general counsel that when you get down to the county level that that gets too close and patients, to protect patients' rights we will not give that information out. And so there is a case where you get States with very--not very populated and maybe have one hospital, all right, that is the information then could actually get back. And those patient rights need to be protected. So there is a case. Mr. Shimkus. Yes, again I am going to keep, we are going to keep following up on this line of work because I think where there are some legislative fixes here and where we can protect propriety and carve out provisions because we need information. And I think the first panel talked about transparency when there is a national emergency. If we are talking about bio- terrorism and the risk of millions of people we surely do not want privacy considerations to trump the health and welfare of the nation. So and the Chairman's position also was if we get sent down the wrong path, as this case is happening, how do we clear the product that has now lost immediate dollars and potentially market share, how do we, who calls it and says lay off the tomatoes? Dr. King. Dr. King. Thank you, Congressman. You know, we respectfully disagree that tomatoes were not involved. And so if you give me a little bit of time to talk about what happened in that case control study if you would like for me to explain that, to talk about the science and the epidemiology behind it, that is your call. Mr. Shimkus. Well, my time expired. If the Chairman wants to hear it I would be happy to hear it. Mr. Stupak. Well, yes, let us hear it. Because how do you prove a negative? You put a negative out there and you still cannot prove that negative. Dr. King. It is an important point to make, so let me go back. And, you know, I apologize for the terms in the epidemiology, I do not apologize for the science. So initially when we had these cases in New Mexico, New Mexico went ahead and went back to ill people and did what they call hypothesis-generating interviews. And that hypothesis generating, I think your committee had copies of this. Mr. Stupak. It is all right here, Yes. Dr. King. Absolutely. Was pretty comprehensive. It included at least 200 different sources of food. Mr. Stupak. But even at that time you knew tomatoes coming from South Florida does not go to New Mexico. That is the traceability thing that they are arguing with you. And if you will not give them the county they cannot help you. Dr. King. Yes, sir. You know, it is what you know at that point in time. Mr. Stupak. Right. Dr. King. So, you know, at that point---- Mr. Stupak. Well, you knew that South Florida was the only place that there was producing tomatoes for distribution in the United States, there and Mexico. So if Florida has this great traceability why did you not work with them so they could show that was not Florida tomatoes to we could have protected the domestic tomato industry which has lost $100 million and counting? Dr. King. So let me just go back and explain the ep--the trace-backs are part of what FDA does, not what---- Mr. Stupak. Well, that is part of epidemiology, is it not? Dr. King. It informs trace-backs for sure, absolutely. And they go together. So you are absolutely right. So through the hypothesis-generating interviews and through the case control studies that followed, right, and the case control studies were done by Texas, New Mexico, and the Indian Health Service, and the analysis of the data strongly associated tomatoes as the possible cause of this outbreak. And when I say strongly associated, you have to understand what that is in epidemiologic terms. When we did the calculations, epidemiologist statisticians, right, that means that people that were ill with this form Salmonella Saintpaul that was in this particular pulse field were 7 times more likely to have eaten raw tomatoes. And when you did further probabilities of the calculation, right, they do what is called a P value. This is the probability that came up with .001. That was 10 times greater in terms of what it would take to publish the scientific data. So with that information in mind and epidemiologists and talking to other people that do this and which we have done for 30 years, right, that is a strong association. Mr. Stupak. Agreed. But when you made that strong association, May 22 is when CDC and State health officials identified outbreak of Salmonella Saintpaul, and within a few days you said tomatoes was the probable one; right? Dr. King. Had the strongest association. Mr. Stupak. Sure, strongest association. OK. But then if it is tomatoes is not the next question where the tomatoes come from? And we know from all the testimony the only place is Southern Florida which has the strongest, as they say, traceable product of tomatoes. And they say you would not work with them. The first line of Mr. Bronson's testimony. Give me the first line of that testimony. His first line of his testimony, written testimony which he gave us was, his first line was, ``FDA did not share or solicit critical information from State food safety agencies. State resources could have augmented FDA's effort.'' So if you are--and I understand epidemiology, I understand statistics, also understand doing crime scenes. When you got a crime scene everyone is a suspect but the infant probably can be cleared immediately because they do not have the means to cause the harm. So for the tomato industry I guess I am saying if you knew it was South Florida, you knew it was tomato, South Florida's tomatoes were not going there, they could trace that, they could prove that to you, then what went wrong after that? We just kept focusing on the tomato. I understand that but domestically-produced tomatoes? Dr. King. Well, CDC does not do the trace-back by the way, so. Mr. Stupak. Agreed. But you do the epidemiology; right? Dr. King. The epidemiology. We do the lab. Mr. Stupak. Correct. And you give it to the FDA then do the trace-back. Dr. King. And FDA is informed by what we have with that conversation and it certainly leads them to---- Mr. Stupak. Correct. Dr. King [continuing]. Some indication of best bets in terms of trace-back. Mr. Stupak. Well, what would the information would the FDA receive from the CDC on tomatoes to make it think it is domestically-grown tomatoes when we know it is only coming from a very small part of our company which has trace-back laws? Dr. Acheson. When we were looking at the clusters and the sporadic cases that the CDC and the locals were investigating in the States, that is our start point. And initially in this outbreak we did not have clusters, we were dealing with sporadic cases and individuals. You are dependent on their memory. And they say, well, we bought our tomatoes at such and such a retail outlet. So we would go there and we would trace it back. Mr. Stupak. Correct. Dr. Acheson. And then we are, to your point, asking where could those tomatoes have been distributed? This year what we learned from industry was that because of weather or economic conditions Florida tomatoes were going all across the United States, they were going as far as California. Mr. Stupak. Well that is not what the first panel said. Dr. Acheson. Well, that was what our information. Mr. Stupak. And if they are Florida tomatoes would you not think you would have some sick people in Florida about this same time? These were only West, right, New Mexico and Texas was the only two places the first outbreaks were. If it's Florida tomatoes I would think Florida people would be getting sick. What did we have 4, 4 people this whole time out of Florida and 11 in California I think it was, and 500 in Texas and 100-and-some in New Mexico? Anyway, OK, did you want to add anything more on that, on what you did there? Dr. King. Yes, Chairman. Thank you. Mr. Stupak. Yes. Dr. King. Just to put it in a little bit of a context, so I just went back to 2006 and I looked at 10 outbreaks, right: E. coli in spinach, shredded lettuce botulism, Salmonella in tomatoes, E. coli in frozen pizza, Salmonella in peanut butter, Salmonella in---- Mr. Stupak. Yes, we have done all those hearings. Dr. King. Done all of those hearings. Mr. Stupak. Yes. Dr. King. Let me point out that actions were taken on the basis of epidemiologic investigations on all those in the advance of any product cultures that were done. Mr. Stupak. OK. Dr. King. So the idea that this one is not different than what we usually find. Mr. Stupak. I understand you have a suspect, but you have to put the suspect at the scene of the crime, and you guys sure did not do a very good job I do not think. And I think that is where your problem is. Mr. Shimkus. I will yield back my time here, Mr. Chairman. Mr. Stupak. Yes. Ms. DeGette for questions. Ms. DeGette. Dr. Acheson, do you think that the trace-back in this most recent Salmonella outbreak was done in the best and most timely way it could have been done? Dr. Acheson. With the system? Ms. DeGette. Yes. Dr. Acheson. With the system that we currently have in place, yes. Ms. DeGette. Do you think it is the best system that we could have? Dr. Acheson. I think it could be improved in terms of increasing its speed. Ms. DeGette. And if it was improved then would we have if we had a better system, which I will get into, would we have been able to identify, at least eliminate tomatoes as a potential source and move and try to identify the sources more quickly? Dr. Acheson. I believe that a faster system, and you could talk about what that would look like, but I believe that a faster system would allow you to exclude products faster and to get back to potential areas where factors are crossing over to give you a source faster. Ms. DeGette. Now, let me ask you this. We heard on the last panel that there are a number of voluntary industry associations for trace-back and also a number of companies have trace-back systems. Are those going to do the job that you are talking about for speed and efficiency if they do not link up with each other and cross-reference each other? Dr. Acheson. No, not entirely. No. Ms. DeGette. And is a voluntary trace-back system in which only some market players participate going to be adequate to give the speed and comprehensiveness that we need in a trace- back system? Dr. Acheson. No. Ms. DeGette. Now, I have learned in recent months that many larger companies do have the ability to track their food and probably in a better way than smaller firms because at larger companies brand preservation is almost always a key to survival. So my question is if you have a purely voluntary trace-back system will that be as successful as it could be if some market players, particularly smaller market players, cannot participate in the system? Dr. Acheson. Like any system it is as strong as its weakest point. So if you put in a great system and only 99 percent of the industry is using it and you have a problem with that 1 percent, all bets are off, it is not going to work. Ms. DeGette. The whole thing falls apart at that point? Dr. Acheson. It does, yes. Ms. DeGette. Now, I would like to know if the FDA currently has the legal authority to do what some of our panelists on the last panel were talking about which would be to use a numerical unique identifier that can travel with the product and instantaneously identify relevant tracking information like location, time, date, etc., vector in the field. Does the FDA currently have that authority to develop that comprehensive system? Dr. Acheson. Well, bearing in mind that I am not an attorney but my interpretation of that is that we do not have explicit authority to require the level of detail that you are asking for. Ms. DeGette. OK. Dr. Acheson. But it may be better if we get you a written response to that. Ms. DeGette. You betcha. I would love it. And I also, not to rag on you because you have been very cooperative with my office, but I have made about 10 or 12 requests to the FDA, other parts of the agency, in the last year and I must say I have not gotten responses. So I am sure you will respond to my question. Dr. Acheson. I sure will. Ms. DeGette. Now, I wanted to ask a few questions about the other end of this, the identification of the food-borne illness because it seems to me that the problems that we have had in this investigation it is true we do not have the comprehensive traceability system that we could or should have, and it is also true that if we had had a national interoperable system of traceability I believe we could have identified, we could have eliminated foods in areas that were not affected which would have been financially beneficial to those portions of the industry. And we could have also identified the source of the contamination more quickly which would be good for public health. But the other, so the traceability is what I have been focusing on in my legislation. But in truth, really the identification of the situation is of great concern to me and the rest of us because people started getting sick in April, and here we are now at the end of July still trying to figure out exactly where that contamination came from. I think some of it does come from the CDC and the State health departments, so I want to focus on that for a few minutes. And I wanted to ask you, Dr. Jones, is it true that you believe that there are some sizeable communication problems between State agencies, which are often on the frontlines of the outbreaks, and the CDC and the FDA? Dr. Jones. I do. And I think your point is an important one. You know, the farm to fork continuum has all along that continuum there are places for improvement. And there are States that investigate hundreds of outbreaks every year and there are States that investigate a half dozen. And, you know, I think the food is just as safe in both of those States. And if outbreaks cannot be detected and investigated at the local level then we will never know we have a multi-state issue on our hands and be able to even discuss it with CDC or FDA. Ms. DeGette. And I guess I could ask you, Dr. Smith, and you, Dr. Jones, the same question. Do you think all States have enough resources to do that investigation that they need to do? Dr. Jones. Absolutely not. Ms. DeGette. Dr. Smith is nodding yes. Dr. Smith. I agree 100 percent. Ms. DeGette. And is there something at the CDC, maybe Dr. King you can answer, or somebody, is there some resource management at the CDC that works with those States that have less resources to be able to identify these situations? And if it is incomplete what can we in Congress do to help improve our identification system in this country? Dr. Jones? Dr. Jones. I think there are a number of things. And, yes, CDC will respond and provide assistance to any State health department that asks for it. And there is obviously wide variability in what, you know, when a State will pull the trigger. I think there are some very important ways that CDC has provided a lot of support to State health departments. Both of our States are among a group of 10 that are in this Food Net system which gives us, and it all federal resources, it comes through CDC, which supports the half dozen epidemiologists that we talked about. I think that if all 50 States had a system like that that a lot of the problem that we are talking about today would not exist. Ms. DeGette. But, you know, I will say that, I will say that it is all well and good to have the States asking for resources, but when you are talking about identifying either a food-borne disease or a bio-terrorist attack if they do not have the resources to identify the problem in the first place they do not know, it is a real chicken and an egg kind of a problem. Dr. Smith is again nodding yes. You are my favorite witness of the day, you just nod in agreement but you do not ramble on, so good work. Dr. Jones, you mentioned in your testimony that a lot of the reason why critical communication between the federal and the local health agencies is not occurring because of policies that restrict the sharing of proprietary data and information collected in the course of an investigation; is that true? Dr. Jones. Yes. Ms. DeGette. I am wondering, Dr. King or Dr. Acheson, if you can comment on how much of that proprietary information is hurting your agency's ability to collect data and to find the causes of these diseases? Dr. Acheson. Certainly from FDA's perspective we do have a mechanism through commissioned officers at the State level to share that information. But I think as we have addressed, if we can find ways to break down these barriers and these silos, not just with the State partners but with industry because there is no question that they have a significant piece to bring to bear that would be helpful. Ms. DeGette. You know, but part of the problem is, as Dr. Jones states in his written testimony, even though public health epidemiologists can become commissioned by the FDA, he says, ``Most of my colleagues have refused to pursue this, expressly to avoid the untenable moral predicament of having access to data which they would be legally unable to act upon.'' I am wondering, Dr. Jones or Dr. Acheson or anyone else, if you would have any comment on how we can solve that problem if we are going to be able to more quickly to respond to these issues? Dr. Acheson. I would suggest that the way is how do we build these partnerships to be actually successful so that you are not---- Ms. DeGette. That is a good paraphrase of my questions. Dr. Acheson. And I think that that is the process that we have got to address. I do not know what that is going to be. We have got a process that we are going to begin in August. We are meeting with States and locals, FDA, with CDC to look at how can we better build partnerships around protecting the food supply in the United States. There is a lot to b e done. Ms. DeGette. Does anybody else have an idea how we can break some of those problems? This is not very encouraging to me because it seems to me that one of the keys towards identifying towards having State and federal agencies working together to identify these issues is, is there going to be coordination? If we have barriers right now we need to figure out how to break that. And we sit here as a Congress ready to help you, but you are the experts, so I think that we need to figure out how to break these barriers. One last question, Dr. Jones. Do you have examples of actual cases where the barriers of data sharing or other forms of communication between State public health agencies and these federal agencies, the CDC and the FDA, made it difficult to rapidly solve a food outbreak case or quickly act in the interests of public health? Dr. Jones. Yes. and I think I alluded to one fairly generally in my testimony. But, you know, we did have a recent situation where a federal regulatory agency had collected the names of people who had purchased a product which we knew was contaminated. And I know that this frustrated them as much as it did us, but they were not able to hand us the list of the contact information of those patients, victims, for us to be able to call them and talk to them. Ms. DeGette. Thank you very much. Thank you very much, Mr. Chairman. Mr. Stupak. But you were the front line collecting that information; right? Dr. Jones. Some. This came through a mechanism where---- Mr. Stupak. Sure. Dr. Jones [continuing]. Consumers can call in to the FDA hotline---- Mr. Stupak. Right. Dr. Jones [continuing]. And ask them questions. And we do not have access to that system. Mr. Stupak. Mr. Dingell for questions, please. Mr. Dingell. Mr. Chairman, again I thank you for your courtesy and commend you for your labors in this matter. These questions to Dr. Acheson. These will be yes or no questions. FDA had over 4,000 field investigators in the year 2003 to investigate contamination of food outbreaks and inspect food facilities; true or false? Dr. Acheson. In 2003? Mr. Dingell. In 2003, had 4,000. Dr. Acheson. I would have to check. Mr. Dingell. Please check. And in 2008, FDA's field force of investigators had been reduced to about 3,300 investigators, that is a loss of 700 investigators; true or false? Dr. Acheson. I believe that is true. Mr. Dingell. Tracking food-borne contamination outbreaks is labor intensive? Dr. Acheson. I am sorry, say again? Mr. Dingell. Tracking food-borne contamination outbreaks is very labor intensive? Dr. Acheson. Yes, agree. Mr. Dingell. What level of food-related resources, inspectors, scientists, etc., do you believe that Food and Drug currently needs? You may submit that, the response to that question for the record. But it would be fair to say that the number is rather larger than you have now, is it not true? Dr. Acheson. I would agree. Mr. Dingell. We are now learning that the probable or possible source of contamination in the jalapeno peppers and tomatoes is Mexico; is that true? Dr. Acheson. Correct. Mr. Dingell. FDA has minimal resources to inspect food imports at the border? Dr. Acheson. It depends how you define minimal. Mr. Dingell. Minimal. All right, is Food and Drug's resources in these matters adequate? Dr. Acheson. No. Mr. Dingell. They can inspect, as I understand it, about 1 percent of---- Dr. Acheson. That is correct. Mr. Dingell [continuing]. The food? Dr. Acheson. That is correct. Mr. Dingell. Clearly that is not adequate; is that right? Dr. Acheson. That is correct. But as we said before, you cannot inspect your way through this. It has got to be a risk- based approach. Mr. Dingell. All right. Now, it is also true that Food and Drug has almost no resources that it can dedicate to inspect foreign firms, foreign farms that handle food; is that true? Dr. Acheson. In 2007 the FDA conducted about 95 inspections of those types of facilities. Mr. Dingell. Do you know how many facilities there are? Dr. Acheson. There are a little over 200,000 that are part of the bio-terrorism registration database. Mr. Dingell. And you inspected, as I understand, 95 of those 200,000? Dr. Acheson. Correct. And do not ask me the percentage because I cannot work that out in my head, please. Mr. Dingell. Is a fair comment minimal? Dr. Acheson. It depends how you define minimal. Mr. Dingell. All right. Now, if Food and Drug had had sufficient resources for inspecting imported produce or actual sources of that produce we could have detected this contaminant much sooner, could we not? Dr. Acheson. I suspect not. Mr. Dingell. Suspect no? Dr. Acheson. No. I think not, because inspections and sampling as a mechanism to ensure that it is safe is not realistic. You just could not sample enough to make it realistic. Mr. Dingell. Right. Dr. Acheson. The answer is the preventative controls; that is the fix. Mr. Dingell. Now, would you agree that FDA needs considerably more resources to conduct foreign and domestic inspection of food processors? Dr. Acheson. Yes. And we are getting some of those in 2008 and hopefully 2009. Mr. Dingell. Now, does Food, would you agree that Food and Drug needs considerably more resources to inspect actual imports at the border? Dr. Acheson. Yes. Mr. Dingell. If you turn to page--I am sorry. I guess that constitutes my questions. Mr. Chairman, I thank you for your courtesy. Thank you, sir. Dr. Acheson. Thank you. Mr. Stupak. Thank you. Mr. Inslee for questions, please. Mr. Inslee. Thank you. I think we all agree that our trace- back and investigatory systems are inadequate. But I want to ask what is more inadequate, our after-the-fact trace-back investigatory system or preventative systems of agricultural practices that prevent, and packaging and distribution practices that would prevent these instances from happening? What is sicker? What is more ailing? What is more porous? What is most, what is the most glaring weakness between those two approaches, either pre- or post-injury? Dr. Acheson. If I could respond first I would say the most critical is the preventative controls. That is what counts the most, building the safety in up front so whether it be a domestically grown or an imported product, manufactured, whatever it is, build that safety in up front to a standard that is adequate. You have obviously got to have strong reactive capabilities when things do go wrong. But having a reactive system, however well it works, is just not a good way to protect public health. Mr. Inslee. Well, I would agree with that. And that is why I hope those who are interested in this subject will be very anxious, as I am, to get legislation through to finally adopt best practices in the industry in the field and in the farm and in the packaging plant to prevent these repeated instances. I have to tell you this is very frustrating to sit at this dais time after time after time to see these incidents and we still have not successfully got the industry totally to agree to standards that will prevent these things from happening. So I hope that this continued incident will encourage others to work with us as soon as humanly possible to pass practices that will prevent this from happening. We know this can happen. We have had substantial improvement in the meat industry. We have not had improvement in the produce industry in practices in the field. And I just hope that others agree with Dr. Acheson and myself on the importance of those preventative measures so we can move forward. Dr. Jones, I want to ask you about State measures. I think even a cursory review would show that a relatively small handful of States have been most successful in investigating a disproportionate number of these incidents. And I just want to ask you to, to the extent you can, tell us what do those States have in common, what have they done well? Is it resources? Is it practices? Is it, you know, gubernatorial leadership? What is it and what can we do to get more states to either emulate those efforts or federally remove the necessity of them? Dr. Jones. Unfortunately I think the basic answer is resources. You know, Dr. Smith has mentioned some other things. I mean States that have a very centralized public health and epidemiology structure tend to get information a little bit faster. Laboratories that are well funded and can do their testing quickly and get their results to epidemiologists quickly help. But all of that requires manpower and resources. Mr. Inslee. We were looking for an easier answer actually. Dr. Jones. Sorry. Mr. Inslee. I appreciate that. Dr. Smith, your team had a relatively rapid identification of jalapenos through genetic systems. And, you know, basically what did they do differently than the FDA? What can we do to replicate that on a federal level? Dr. Smith. Right. Well, again I think it needs to be replicated more on the State level because I mean CDC and FDA are kind of limited by the information they are getting from State health departments. And so I think our system or something like it needs to be implemented more at different state levels. Again, our laboratory is confirming and typing bacteria in real time, giving that information to our epidemiologists right away. And our epidemiologist are interviewing these patients extensively, again in real time. And so we are asking people about what they ate 2 weeks ago. And that is hard to get detailed information at that point. But it is much easier and you get much better information than if you waited until you ask them about 4 weeks ago or 6 weeks ago. And that is what happens in some States is like some laboratories physically cannot type all the bacteria in real time and so they can only do it once every 2 weeks or once every month. And then by the time they do that and get that information to their epidemiologists, you know, it is 4 or 6 weeks later, you know, when the interviews are being started. So the whole key is just, you know, it is not really that hard, it is the resources to do stuff right away and to do it in detail and that will get you the detailed interview information that you need to solve an investigation. Mr. Inslee. So what would you say to the federal government, the agencies, to match that State input early? Is there something that has to change? Dr. Smith. Well, I mean I know for a fact that CDC could use more resources in PulseNet to track all the isolates that are being submitted by State health departments into that. And I also know there are epidemiologists that are helping to coordinate multi-state outbreaks get stretched awfully thin. And so, again, I know that they could use more resources at the federal level to go ahead and assimilate the information that is coming in from the States. Mr. Inslee. Anyone else want to add to that? [No response.] Mr. Inslee. With that, thank you very much, I yield back. Mr. Stupak. Ms. DeGette had a question? Ms. DeGette. Mr. Chairman, I just had a follow-up question. I am trying to, I am still trying to think about how we could improve our identification of these outbreaks. And, Dr. King, I wanted to ask you in particular about this Salmonella outbreak. Now, patients were given or people who we thought ate the tainted foods were given questionnaires by the State of New Mexico and also the CDC; is that correct? Dr. King. Yes. Ms. DeGette. We have been provided copies of these questionnaires by the CDC and I am wondering are these confidential, these forms? I know the ones filled out are confidential. But I am looking at them, I see no reason why these would be confidential in any way. Dr. King. The forms? Ms. DeGette. Yes. Dr. King. No, not at all. Ms. DeGette. OK. And the first form, which is a very extensive form that was provided by New Mexico to patients, talked about fresh tomatoes and it had a long list of different foods. And it did not highlight jalapeno peppers or serrano peppers, just simply had a space for other peppers. And then the form that was given out by the CDC, which is a form much more targeted at the salsa that was suspected asked questions about salsa, homemade salsa, store bought salsa. It talked about onions, tomatoes, where you ate tomatoes, a lot of questions about tomatoes. That form never asked one question about peppers. And I am wondering why? Or, for that matter, any other ingredients other than onions that are in salsa. Dr. King. There are two different forms. The first one is this hypothesis generating form. Ms. DeGette. It is the larger form provided by New Mexico which has a whole bunch of stuff on it. Dr. King. Right. And I think red peppers, green peppers or other peppers. Ms. DeGette. Correct. Dr. King. Also, the people doing the interviews it was open-ended so you would also ask people are there other things are not on this list that you could remember that you had. So that is one thing. Ms. DeGette. OK. Dr. King. When you get down into case control, which is the second form---- Ms. DeGette. OK. Dr. King [continuing]. It also was done by the State, actually two States. Ms. DeGette. And that is like a smaller format. Dr. King. The difference then is that because the hypothesis has been generated, right, then we are able to focus into this looks like it is food, looks like this type of food. And so the questionnaire then becomes more focused based on that information to try to pinpoint more accurately the different types of foods and ingredients. Ms. DeGette. That makes sense to me. So who develops that second form? And that is like a follow-up set of questions that is asked? Dr. King. Yes, ma'am. That is correct, Congresswoman. Ms. DeGette. And who develops that form? Dr. King. Well, the States will actually have some changes in those depending on what they do. There is kind of a template that is being used but States will add to those as they---- Ms. DeGette. So the State of New Mexico would have developed that second form? Dr. King. They would have. Ms. DeGette. OK. Dr. King. For the case control study we actually were involved in helping them with that. Ms. DeGette. Well, and the reason I am concerned is this: it may be that after the initial survey that people did not focus in on pepper. However, if you look at this second follow- up form they were focused in on salsa; right? Now, I will tell you as someone who myself is from the Southwest, I never made salsa without putting peppers in it. That is one of the key ingredients of salsa. So if in fact salsa was suspected and you ask the question tomatoes, and extensively tomatoes and onions, why was not the question about peppers asked on that follow-up questionnaire? It may have helped you much more quickly identify the serranos and the jalapenos? Dr. King. Now I have to look at the questionnaire. Again it was--no, I understand that you are looking at that. So I would look at the second---- Ms. DeGette. I will tell you---- Dr. King. Yes. Ms. DeGette [continuing]. Without misleading you that peppers are not mentioned whatsoever on this second form. There are many questions about tomatoes. Did you eat any raw tomatoes? Did you eat tomatoes at a restaurant? Where did you purchase them? It seems like what happens was the State of New Mexico and the CDC focused right in laser-like on tomatoes. But yet, if they thought the problem was salsa maybe they should not have, maybe they went off down the wrong road too fast. Dr. King. That is, you know, that is part of something we would look at. The second case control study certainly did focus at peppers as we gained more information as we went. Ms. DeGette. OK. I do not think we have that in our--oh here. Here is Mexican food exposure. Then would that have been the next thing after that? Dr. King. That is correct. Ms. DeGette. OK. When was that given to them, after the tomatoes were eliminated as a suspect? Dr. King. As we gained more information then we were able then to focus more and peppers became something of more concern for us and with stronger association. And consequently the questioning and the questionnaires reflected it. Ms. DeGette. Do you think we might have been better off if we focused on all the ingredients of salsa right at the time that we thought salsa might be a problem rather than just going down the tomato road? Dr. King. It may have been. And I can certainly go back and review that. Ms. DeGette. Thank you very much. Mr. Stupak. Dr. Acheson, you have indicated then, and I know we have been down this pass before on Heparin and China and all this with the FDA, but you said that the best way to handle these issues is to build up the safety first, in other words make sure the farm is growing a healthy product; correct? Dr. Acheson. A safe product, yes. Mr. Stupak. Safe product. How many inspectors, full-time inspectors do you have in Mexico then checking farms? Dr. Acheson. Nobody is, no FDA employees are permanently stationed in Mexico. Mr. Stupak. So then the only chance to make sure that you have the safety of the product coming in is catching it at the border then; right? Dr. Acheson. Under the current system, yes. It is based on inspection and sampling at the border. As part of the Food Protection Plan, FDA beyond our borders, we are looking at establishing FDA presence in a number of countries which would include Central and South America. Mr. Stupak. OK. But you are establishing it in China, are you not? Dr. Acheson. Yes, we are in the process. Mr. Stupak. Did you not have the memorandum that was on the pet food? Dr. Acheson. We are in the process of establishing an office in China, that is correct, yes. Mr. Stupak. So do you have any food inspectors outside the borders of the United States? Dr. Acheson. Not currently, no. Not permanently. Not permanently. They would go out usually for cause. If we know of a problem that needs to be checked on. Mr. Stupak. Correct. There has to be a problem first before you will send them off over shores, offshores? Dr. Acheson. Typically, yes, there does. Mr. Stupak. So but to get to your safety, build up the safety, as you have said---- Dr. Acheson. Yes. Mr. Stupak [continuing]. You really should have the inspectors in other countries, especially like in the winter months we know we get most of our produce at least south of our border. Dr. Acheson. It is not all about inspections, it is about building in the preventative controls. So we have got to set the standards, we have got to work with industry to do that, and we have to find a way to ensure that they are meeting those standards. Some of that would be FDA inspections. As I know you are aware, an area that we are exploring as a mechanism here is an FDA-audited third party certification system. Mr. Stupak. Correct. Dr. Acheson. Simply because, as I said to Congressman Dingell, we are looking at 200,000 foreign manufacturers. And it is like let us focus on those that are high risk and let us leverage every possible mechanism to be able to ensure that they are building the safety in up front. Mr. Stupak. OK. Now, Dr. King, if I may ask you, who is in charge of coming up with the source here of the Salmonella, the vegetable of interest if you will, the CDC? Dr. King. The original epidemiology CDC is actually, that is our responsibility. Mr. Stupak. OK. So CDC told FDA look at tomatoes? Dr. King. Yes. Mr. Stupak. OK. Then who made the call to change the focus to peppers, CDC or FDA? Dr. King. It came through further investigations. By the way, we do not do this kind of by ourselves, we do this through conversations back and forth. Mr. Stupak. Correct. Dr. King. Our investigations and the epidemiology led us to look more and more toward peppers. And I know Dr. Acheson and folks at FDA. That was from our investigations then that led them to further trace-backs down that track. Mr. Stupak. OK. Who is the agency in charge then when you have a food-borne illness outbreak, CDC or FDA? Dr. King. It depends on what part of the outbreak. So we do surveillance, we do epidemiology, we do outbreak investigation and the laboratory. We do not do the trace-backs. Mr. Stupak. Right. Dr. King. So that is the bifurcation. FDA does the trace- backs, the work on the food, or USDA depending on what the product is, and so they are clearly in charge of that part of it. We are clearly in charge of the other part of it. We talk all the time, meet all the time. But that is how the delineation is. Mr. Stupak. You say you talk all the time but yet when I hear Dr. Jones talk it sounds like no one talks to the State officials who are really the frontline people, who really do your epidemiology and stuff that Ms. DeGette went over, the forms. Because I am still bemused by the fact that Dr. Jones testified if they have an outbreak you know the names and addresses, or FDA does, of the people who are being sick but they cannot tell the frontline people, Dr. Jones, to warn them or to try to at the local level take care of the issue. I just find that amazing. Dr. King. Thank you. And I will talk to Dr. Jones about that. And I am sure he has good reasons to say that. There are three systems that we have kind of in effect. One is called Outbreak Net where we actually have the epidemiologists in every state and CDC involved. The other are daily conference calls during this outbreak with all the States involved. And the other is CIFOR, which is this council to improve food outbreaks. And that involves States and epidemiologists. So there are three systems in place where I think the dialogue continues fairly readily. Mr. Stupak. Three systems in place. So would it not really indicate that you need an incident command center that would include State, local, federal, industry reps, science experts, especially when you get an outbreak as big as this, 43 States, District of Columbia, Canada? Dr. King. I think that is something to take a look at. And I appreciate your observation on that. Mr. Stupak. Go ahead, Mr. Shimkus. Mr. Shimkus. Yes. And just if this was a bio-terrorism attack and then that is, and this is what we are all, a lot of us are concerned with and you, we have said the system works the same, but as far as the command and incident center does the Department of Homeland Security get involved in that debate then? Dr. King. Yes. Mr. Shimkus. Is that the command and control center that we lack here? Dr. Acheson. If there is--well, thankfully we have not had to deal with one of those since---- Mr. Shimkus. That is true. But I mean we have to be-- hopefully we do not--but we need to start, we cannot shy away from the risk and we have to ask these questions. Dr. Acheson. Yes. Mr. Shimkus. And this case study is a good case study to help us look at that. Dr. Acheson. If it was a deliberate act and we knew it was deliberate, and I want to add that if somebody was putting Salmonella in the food supply the chances are that they would be treated exactly the same as this because it happens, unfortunately, too often. If it was anthrax, which clearly happens never, then it would be, the suspicion would be much higher, law enforcement would be involved very early, and I think the whole thing would be different. Mr. Shimkus. But they would call upon you all for your expertise in the public health departments? Dr. Acheson. Oh yes. Mr. Shimkus. In your trace-back? Dr. Acheson. Yes. Mr. Shimkus. And CDC. Dr. Acheson. But I think your point and Chairman Stupak's point is an incident command type approach for dealing with these is one that seriously needs to be looked at as a mechanism that involves at the very least the regulatory individuals that are seated here, and others. The industry piece is more complex because of the sharing of confidential information. And I would love for us to break down those barriers, it could only help. Mr. Shimkus. And that is what we want to do. Mr. Stupak. But following up on that question, if it is a bio-terrorism attack how does--does law enforcement then and security of our country trump those privacy concerns we have? Does it trump the Privacy Act? Does it trump the agency chief counsel who do not allow you to share that information? When reading the Bioterrorism Act I do not see an exception for that. So it would have been done the same way, not sharing information. Dr. Acheson. From FDA's perspective I do not think anything changes. It may be different for Department of Justice, law enforcement and FDA. I just---- Mr. Stupak. But you do not have any opportunity though if it is a bio-terrorism attack to waive the privacy law, the confidentiality, the trade secrets, whatever you want to call it, proprietary interests I think was the words used earlier? Dr. Acheson. Not that I am aware of but I will take that back. Mr. Stupak. No, I have not seen it either, so. Dr. Acheson. And if there is something in the act to that effect then I will obviously get back to you. Mr. Stupak. And, Doctor, you quoted a legal opinion. Can you provide that to the committee for the record? Dr. King. I would be glad to. That has to do with the county information, yes. Mr. Stupak. Right. That is kind of the direction we want to head. So thanks. Let me thank this panel and thank you again for your time and testimony. And we will continue on this issue. [Witnesses excused.] Mr. Stupak. I would like to invite our third panel of witnesses to come forward. On our third panel we have Mr. Michael R. Taylor, J.D., who is the Research Professor of Health Policy at George Washington University School of Public Health and Health Services; Mr. Hank Giclas, who is Vice President for Strategic Planning, Science and Technology at Western Growers Association; Dr. Donna Garren, who is Vice President for Health and Safety Regulatory Affairs at National Restaurant Association; and Dr. Robert Brackett, who is the Senior Vice President and Chief Science and Regulatory Affairs Officer at the Grocery Manufacturers Association. Thank you all for coming. It is the policy of this subcommittee to take all testimony under oath. Please be advised that witnesses have the right under the rules of the House to be advised by counsel during their testimony. Do any of you four wish to be represented by counsel at this time? [No response.] Mr. Stupak. Everyone indicating no. Then I will ask you to please rise, raise your right hand, take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect the witnesses applied in the affirmative. You are each now under oath. We will now hear your opening statement, 5-minute opening statement. You may submit a longer statement for inclusion in the hearing record. Professor Taylor, let us start with you, sir. STATEMENT OF MICHAEL R. TAYLOR, J.D., RESEARCH PROFESSOR OF HEALTH POLICY, THE GEORGE WASHINGTON UNIVERSITY, SCHOOL OF PUBLIC HEALTH AND HEALTH SERVICES Mr. Taylor. Thank you, Mr. Chairman, I appreciate the opportunity to testify today. I have submitted a written statement, the purpose of which was to demonstrate that we have a system problem here. And I think it is fair to say that the testimony you have heard so far really demonstrates that, I think really demonstrates we need a system solution. And I look forward hopefully this panel can have some time to talk about some of those solutions. But in my written testimony I tick off really 7 elements of preparedness and planning for outbreak response and investigation that are really lacking in the current system. And I think we have heard about all of these today: And it is focused federal leadership and accountability, it is somebody being in charge. It is well-defined institutional roles across the system, federal, State, and local, which we really do not have formalized today, it is very ad hoc. Adequate expertise in capacity, the funding issue that we have talked about; clearly an element of this. Prompt trace-back. And I think we can talk about some specifics there. This issue of standardized data collection and seamless data sharing I mean I think is really central to being able to manage these outbreaks and also to deal with prevention in a systematic way. And we do not have that provided for. We have also heard about the need for active industry engagement, which I absolutely agree with. And then coordinated public communication is obviously essential. I guess one thing I really want to emphasize is that Congress has to act to address these problems. I think these problems are built into our current system, the current fragmentation organizationally in our food safety system at the national level. It goes beyond outbreak investigation and response, it really goes to the whole way in which we manage our food safety system and it needs to be transformed. As this committee well knows, we are operating at FDA under a food safety law that is 70 years old that contains no mandate for prevention, it contains no mandate to take an integrated systems approach. I think the legislation you are working on will address that. The other element, of course, of the broader problem is resources. We have talked about that today. I would just like to emphasize the organizational issue. And there has been an extensive study of this by the Government Accountability Office, by the National Academy of Sciences, the fragmented structure of the government's food safety system, particularly at the federal level, but then also as we have heard today, State and local agencies. It is health departments at State and local level, it is regulatory agencies, it is Departments of Agriculture, all of whom play roles without any sense of how we or any clear directive. It could be a national leadership role in seeing that entities work in an integrated way. So Congress really has to address this organizational, this structural issue and really drive the development of an integrated system. I would start that organizational reform at the Department of Health and Human Services personally. Within HHS we have food safety agencies, multiple components really of the Food and Drug Administration as well as CDC, you know, all of which work in their own traditional ways with their own particular charges. They have their own cultures and ways of dealing. None of them have the charge or the stature within the government system to really exert leadership, nationally and internationally for that matter, towards a more integrated preventive approach. So one of the things I would hope this committee would consider in due course is unifying and elevating within HHS all of the components of HHS working on food safety so that single office, a single official can be in charge and accountable for all HHS food safety activities, including outbreak response and investigation, but going beyond that to include all the things we need to do to build a preventive, integrated food safety system in the country. So with that I look forward to the opportunity to discuss any of these ideas and solutions to some of the problems that have been identified here today. [The statement of Mr. Taylor follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Mr. Giclas please. STATEMENT OF HENRY GICLAS, VICE PRESIDENT, STRATEGIC PLANNING, SCIENCE AND TECHNOLOGY, WESTERN GROWERS ASSOCIATION Mr. Giclas. Thank you, Chairman Stupak, members of the committee. Western Growers is a trade association representing growers, shippers and handlers of fresh fruits, nuts and vegetables in California and Arizona. Our 3,000 members produce approximately half of the United States' total production of fresh fruits, nuts and vegetables. We appreciate the opportunity to speak before you today on our activity and learnings related to food safety. The industry has a long history of implementing and improving our food safety programs and defense capabilities to protect public health as well as business interests. In the early 1990s we led to develop the first ever Good Agricultural Practices document that recommended key areas and strategies for reducing risk. These guidelines addressed production, harvest, cooling, processing, transportation, and retail and food service handling. They later became the basis for the FDA's Guide to Minimized Microbial Food Safety Standards for Fresh Fruits and Vegetable--excuse me, Hazards. Today that is the baseline for all food safety guidance. When the Guide was published our emphasis shifted to one of education of extension. A cottage industry of third party food safety consulting and auditing firms began to grow. These programs have driven a high level of implementation as buyers demand audits as a condition of doing business in the marketplace. This benchmark set of guidelines and food safety paradigm has evolved significantly over the last few years for select commodities. Today, commodity-specific guidance has been developed for lettuce and leafy greens, tomatoes as you saw this morning, and cantaloupes. And there is work under way on green onions and herbs. These are each grounded in the FDA Guide and utilize an approach based on hazard identification, assessment and control. Despite the continuing improvement in guidance there have also been continuing outbreaks. The 2006 outbreak in spinach drove the industry to move far beyond existing paradigms to even more prescriptive sets of best practices. California and Arizona now have established uniform GAPs and a corresponding verification program that requires implementation of food safety measures developed in concert with public health authorities and private sector experts. These newer generation guidelines include specific requirements for risk assessment, sampling and analysis of inputs, safety response measures and requirements for documentation. Compliance with these requirements is verified by government inspectors in the field. And we believe this model should provide direction for broader national and international efforts to improve food safety. The model program brings together the strengths of State and federal government, the national and international research community and the industry itself in a coordinated fashion to ensure science-based best practices for preventing or reducing the potential for contamination. The Health and Human Service agencies are in a key position to identify the areas that industry must address based on the data and information they have gathered and analyzed in epidemiological investigations and trace-back. Addressing these risks in turn becomes the focus for enhanced best practices. Verification can rely on inspectors who are already in place throughout the country. FDA is exploring this option by evaluating how third parties might assist in providing ``boots on the ground'' for verification and inspection. Western Growers firmly believes that prevention is our strongest tool in efforts to reduce food-borne illness associated with produce. But a model program also must address the response to any discovery of contaminated product in the marketplace or outbreak of food-borne illness. Collaboration is equally important in efforts to respond. The FDA and CDC have an army of industry personnel at the ready. A formal recognition of this industry expertise and a commitment to strengthen communication with industry during an outbreak will both help protect the public and minimize economic damage to the industry. We believe the time has come to cease operating in silos and work hand-in-hand using the strengths, talents, and expertise of all parties to improve food safety. The program for leafy greens adopted in California and Arizona is moving the industry closer to achieving our common goal of minimizing the incidence of food-borne illness associated with the consumption of fresh product. We encourage this committee to assist the industry to build on and extend the success of these efforts. I appreciate the opportunity to testify today on behalf of Western Growers. I look forward to any questions you might have regarding our efforts. [The statement of Mr. Giclas follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Dr. Garren, your testimony please. STATEMENT OF DONNA GARREN, PH.D., VICE PRESIDENT, HEALTH AND SAFETY REGULATORY AFFAIRS, NATIONAL RESTAURANT ASSOCIATION Dr. Garren. Chairman Stupak and members of the subcommittee, thank you for this opportunity to testify before you today on the recent Salmonella outbreak. The National Restaurant Association, founded in 1919, is the leading business association for the restaurant industry, which is comprised of 945,000 restaurant and food service outlets and a work force of 13.1 million employees, generating estimated sales of $558 billion in 2008. Nationwide, the industry serves 133 million guests every day. Food safety is the utmost importance to the restaurant industry. Restaurants have taken the lead in assuring food safety within the four walls of our restaurants. The National Restaurant Association and our members are making multi-billion dollar investments in improving food safety and developing state of the art food safety education programs. We are especially proud of ServSafe, the food safety education program that sets the standard for our industry. More than 3 million food service professionals have been certified through our ServSafe Food Protection Manager Certification exam. The current Salmonella outbreak is one of the largest in U.S. history. Of particular concern was the over 2-month period of time needed to identify the source of the outbreak and the mid-course change in focus of the cause of the outbreak. We are at a critical time in food safety, and all of us have a road to play. This highlights, the outbreak highlights the need to re- evaluate our food safety system and implement needed improvements. Of particular concern is the complexity of the food distribution channels for fresh produce and the challenges presented when a finished product served to customers contains a number of ingredients. This complexity presents challenges to the public health officials leading the efforts to resolve this outbreak in timely manner. In moving forward, we need a better approach. We need a farm-to-table approach. We build confidence by showing people that we are always ready, always vigilant. For the purpose of this hearing we would like to focus on key areas of moving our food safety efforts forward. Adequate funding for FDA, improved collaboration and communication, stronger standards and practices for produce, and additional tools that include recall authority, traceability, improved epidemiological investigations, and private sector certification. The recent outbreak highlighted the need to provide FDA with adequate resources to do its job. We are encouraged by the Fiscal Year 2008 supplemental increase for FDA of $150 million, further increases recommended for Fiscal Year 2009 budget as well. However, this can only be a down payment on a sustained effort to increase the agency's appropriated base. This outbreak also highlights the need for increased collaboration and communication between industry and government. The fact that fresh produce is commingled and repacked at various steps in the chain should not present an insurmountable problem. There are industry experts who specialize in the distribution of these types of products. There should be a mechanism that allows the agency to tap into this expertise to facilitate a more meaningful investigation of the crisis at hand. While we recognize that conducting an outbreak investigation is a governmental function, we would urge a greater level of collaboration and communication between government and industry, as we all benefit from a rapid resolution. Effective communication guides the public, the news media, healthcare providers, and industry in responding appropriately to outbreak situations. There are certain challenges and hurdles inherent in developing materials to inform and educate the public about potential health and safety risks in an accurate and timely manner. We must overcome these obstacles and improve how we communicate health and safety information. It would be a serious error to underestimate the importance of developing, by consensus among stakeholders, the final version of risk communication strategy and plan. Communications professionals in the public and private sectors need to ensure strong and well-integrated working relationships that will help sustain communications resources as an outbreak evolves. The planning, preparation, and practice must begin now. Over the past several---- [Bells.] Mr. Stupak. Stop. Soon as we start again. Go ahead. Dr. Garren. OK. Over the past several years, there have been repeated calls for stronger safety standards for fresh produce. This outbreak reinforces the importance and urgency of that task. The produce industry has taken positive, proactive steps to establish standards. Now it is time for the FDA to take the next step. The first goal of any food safety system must be prevention. FDA's good agriculture practices, developed a decade ago, should be updated and made mandatory. The National Restaurant Association supports the FDA in setting mandatory general standards for produce as well as commodity-specific standards for commodities the FDA deems as posing a higher risk. Prevention alone cannot guarantee safety and so emphasis must be placed on rapid response when an outbreak does occur. This leads directly to the issue of traceability. The produce industry has made important strides in recent years to improve traceability, yet more can be done. We must apply our best collective knowledge, expertise, and emerging technology so that finding the source of contaminated produce is a matter of hours or days, not weeks or months. Traceability systems may need to be developed commodity by commodity to address varying supply chains. A one-size-fits-all strategy may not work for all sectors and stakeholders. In addition, any credible traceability system should be effective for all stakeholders and routinely tested to determine potential flaws prior to a crisis event. The National Restaurant Association supports granting the FDA the authority to recall a food product that poses serious adverse public health risk and the company refuses to complete a voluntary recall. Enhanced and coordinated recall notification should be developed to better inform the consumer so that the FDA is communicating these notices to the public in a consistent manner. We also believe that there should be better resources for investigating outbreaks at the State level. The epidemiology of food-borne illness is sophisticated and always changing. Many States lack the manpower and resources to do it well. Poorly managed investigations can be catastrophic, as we most recently demonstrated by this particular outbreak. We must ensure States have the necessary funding available to access this information and implement better investigations related to food. Increasingly, our members are relying on private sector to ensure compliance by suppliers with food safety standards. This approach provides consistency of standards and quality across b orders, cost efficiency in the supply chain, and less duplication of certification processes, and simpler buying. We believe the FDA should support the use of third party certification as a way to leverage the agency's limited resources. In conclusion, the ongoing Salmonella outbreak has been long, costly and frustrating for all concerned. We must do better. This means taking a new look at our food safety system to ensure we have a comprehensive farm-to-table strategy. We must look for ways for government at all levels to collaborate more closely with industry experts during the course of an outbreak investigation. And we must establish stronger standards and practices that move us towards continuous improvement in produce safety. Thank you for this opportunity to testify. [The statement of Dr. Garren follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you, Dr. Garren. Dr. Brackett, your testimony please, sir. STATEMENT OF ROBERT E. BRACKETT, PH.D., SENIOR VICE PRESIDENT AND CHIEF SCIENCE AND REGULATORY AFFAIRS OFFICER, GROCERY MANUFACTURERS ASSOCIATION Mr. Brackett. Thank you, Chairman Stupak and other member of the subcommittee. The Grocery Manufacturers Association represents the world's leading food, beverage and consumer product companies, and the members of GMA share your commitment to ensuring the safety of our nation's food supply. Product safety is the foundation of that consumer trust. The recent investigation into the food-borne illnesses outbreaks due to Salmonella Saintpaul is the latest event to challenge our whole food safety system. The inability of the current food safety system to rapidly and accurately determine the source of Salmonella Saintpaul in this outbreak is a major contributor to the erosion of consumer confidence in the safety of the nation's food supply. The topic of this hearing is what we have learned as a result of the Salmonella outbreak. And we have learned three things. Clearly, the first thing we have learned is that FDA is in dire need of additional resources to carry out its mission of protecting the public from food-borne hazards, and not just money but in terms of scientific expertise and IT infrastructure. And all of that goes along with protecting the food supply. Secondly, we have learned that the ability to trace a product is meaningless if the epidemiological data implicates the wrong product. This highlights the need for more resources at the State and local levels as well so that we can more rapidly and thoroughly investigate these food-borne illnesses if they occur. Third, we have learned the need to do more to prevent food safety incidents in the first place. The GMA has led the effort to provide current guidance to the food industry, both domestically and abroad, by issuing the GMA Food Safety Chain Supply Handbook this past April in 2008. And I have a copy of that here for you. This reference manual represents a tool chest for companies in search of examples of successful management practices for suppliers to consider. The GMA Handbook clearly states that at a minimum, suppliers and transporters should consider their ability to trace back and trace forward the movement of ingredients and finished goods through the whole supply chain. But traceability was not the real issue in the Salmonella Saintpaul outbreak that we are discussing today. We really need to modernize our entire food safety system. GMA continues to propose that Congress modernize our food safety system by making risk and prevention of contamination the focus of our food safety strategies going forward. GMA CEO Cal Dooley and I have testified many times before Congress on the issue of improving food safety. We have consistently proposed the following reforms, many of which are included in legislation already introduced in both the House and the Senate. These include first: One, that we urge you to give FDA the power to establish mandatory safety standards for fruits and vegetables. In particular, give FDA the power to establish food safety standards for those fruits and vegetables that have repeatedly been involved in food safety incidents. Two, we urge you to require food companies to have a food safety plan. In particular, every food company selling food in the U.S. should conduct a food safety risk evaluation that identifies potential sources of contamination, identifies appropriate food safety controls, and verifies that those controls are effective, and then documents those controls in the food safety plan subject to FDA review. Now, with respect to trace-backs, Congress and the FDA should evaluate the trace-back requirements in the Bioterrorism Act to determine whether it should be extended to farms, given these recent developments. In addition, there is also one inadvertent outcome from the Bioterrorism Act. The law clearly requires food companies to keep the ``one up-one down'' records that have been discussed so far. However, there appears to be some ambiguity as to whether the law gives FDA the express authority to check during a routine investigation to see if a company is, in fact, keeping such records. We believe Congress should clarify FDA's authority. By expressly granting FDA such authority, FDA can better assess whether companies are properly prepared to trace product when a food-borne incident does occur. Third, require every food importer to police their foreign suppliers. In particular, Congress should require that all food importers document the food safety measures and controls being implemented by their foreign suppliers and should require food importers to make their foreign supplier food safety plan available to FDA. And, four, build the capacity of foreign governments and enlist the help of the private sector. In particular, Congress should direct FDA to develop a plan to help build the scientific and regulatory capacity of major exporters to the U.S. and should create a registry of private laboratories that meet FDA standards. Mr. Chairman, we are grateful for the opportunity to work with you and promote a risk-based approach to food safety regulation and to allow FDA the flexibility to respond to emerging risks in the manner that most efficiently uses the agency's precious resources. We look forward to working with you to develop and implement improvements that will make risk and prevention the focus of our nation's food systems. This concludes my oral testimony. And my written testimonies have been submitted for the record. [The statement of Dr. Brackett follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. And thank you all for you testimony. Unfortunately, as you know, with the bells ringing we have votes. We have 5 minutes left on the floor for us to go vote. We have six votes. I want to say 3:15 we will come back and we will go with questions. I hate to ask you to stay another hour but we want to get the questions in. So let us come back here at 3:15. OK, the committee will be in recess until 3:15. [Recess.] Mr. Stupak. I thank you for staying with us. And sorry, we thought it was going to be a short deal. There was a special motion on the floor, took a little bit of time, that is why we are an hour late, or for those of us who live in Central Time Zone we are right on time, 3:15. But we will start with some questions here. Let me ask this, Mr. Giclas, when this outbreak first occurred and tomatoes were named as a possible source of Salmonella, large portions of Florida or in this case the entire State of California were not in production and, therefore, it would have been impossible for Salmonella to be in the tomatoes. Nonetheless, almost the entire growing industry has been broadly painted, and still is today, with the same brush, at least in the eyes of consumers. Is there anything with respect to CDC or FDA's messaging to the public that can be improved so not to hurt certain parts of industries that are not responsible for outbreaks? Mr. Giclas. Mr. Chairman, my response to that would be I think there is a lot of room for improvement in the messaging in a couple of different ways. First of all, I think that CDC and FDA ought to just tell people what they know when they know it and, you know, not get into a position where they are speculating on what other products or what other commodities or what other regions. I think, I also think that the frequency of communication was problematic in this particular outbreak because there was, you know, a series of media calls that were held over and over and over with really nothing new to report other than an update on the numbers, but no significant findings, if you will. Mr. Stupak. OK. Dr. Garren, Dr. Brackett, in the Bioterrorism Act of 2002 both the restaurants and the farms were exempt. Would you now agree that we should put them in the Bioterrorism Act so we can do traceability better? On behalf of the restaurants, Dr. Garren, what would you do, would you agree you should be part of this process? Dr. Garren. We definitely believe that there should be a farm-to-table strategy. Mr. Stupak. How about restaurants? Dr. Garren. Excuse me? Mr. Stupak. Restaurants? Dr. Garren. We want to work with FDA. Right now we would say that, you know, we represent a very diverse industry that goes from the small, independent operator all the way to the multi-unit operators. Mr. Stupak. Agreed. Dr. Garren. And in this particular case, you know, I would say in regards to the Bioterrorism Act I would say we already voluntarily comply with it in that we were able to in this particular case supply information to FDA in a timely manner. It might have been purchasing records for those small unit operators. Those small unit operators that is how they may make---- Mr. Stupak. Yes, but one of the problems is that you may be, if you are not part of the act maybe the records you are, and we have seen this throughout this whole investigation, records you are providing may be something different than what the distributors gave to you. I think and when we were dealing with the other panels you almost need a seamless form system where we are all using the same systems, otherwise it just burdens everybody. You have paper, they have electronic, they have something else, bill of lading, some are on back of a brown bag they said, that is some of their records. Dr. Garren. Right. We would want to work with the stakeholders involved, including government, to come out with an approach that works to integrate commodity to commodity, and incorporate the needs of different stakeholders. I think a one- size-fits-all strategy for traceability might not be working for every particular business type. We need to take into account where we move from here. But we definitely welcome the opportunity to work to move in that direction. Mr. Stupak. Dr. Brackett, do you want to add anything on the behalf of the Grocery Manufacturers? Mr. Brackett. Yes, I would make a comment specifically on the farm side of it. This this is in this particular group of products, those that are high-risk products, most of the problems have been in the past the fact that they have not been able to track back to the farms. And so if you are going to have a farm-to-table approach I think they would have to be included. And I think the industry is well on its way to doing that already. Mr. Stupak. Mr. Taylor? Professor Taylor, do you want to add anything on that? Mr. Taylor. Well, I think as long as you are in the mode of having a system that is dependent upon government investigation of company records and you want a farm-to-table system you have to extend it to restaurants and farms. I guess I would encourage consideration of a completely different approach though. Because in a public health context it seems to me what FDA needs to be able to do is rapidly get trace-back information that the companies have and give answers to FDA as to where a product came from instead of creating company records that then still rely on FDA to do the investigation. So rather than rely on those internal records, you know, I would suggest, for example, as I did in my testimony, creating a performance standard if you will. Mr. Stupak. Right. Mr. Taylor. Having Congress legislate or authorize FDA to do commodity-specific rulemaking that would say based on available technologies everyone in that supply chain should be able to tell FDA within 4 hours, 8 hours, 12, whatever you judge or FDA judges is technologically feasible, the duty is to provide that information within a certain period of time. And then the companies can figure out what specific technology or set of practices work for that commodity or that business model and not get the government into the business of trying to create the trace-back system but set the performance standard that every company has to meet. Mr. Stupak. Or at least some minimum standards that we need for trace-back? Mr. Taylor. Yes. Mr. Stupak. And then let the industry by commodity work on it? Mr. Taylor. Yes. And based on an assessment of what is technology feasible and can be done in a cost-effective way but then leave it to the companies to innovate the specific systems that meet that performance standard for timeliness of disclosure of where a product came from. Mr. Stupak. Mr. Giclas, you indicate that Arizona and California have standards they have developed together for what, leafy greens, tomatoes? Mr. Giclas. Well, the first panel this morning spoke specifically about the standards for tomatoes in California and Florida. My testimony was about the leafy greens program in California and Arizona. Mr. Stupak. Could that be replicated throughout the U.S.? I mean you are the only two States that are doing it right now. Mr. Giclas. It absolutely can be replicated. And it is one of the things that, you know, we are bringing forward as a potential model. It is very similar to what is being done in tomatoes in both California and Florida on the part of the tomato industry. So it is an example of some of the commodities that have been deemed to have higher risk like leafy greens, tomatoes, cantaloupes, there are some others, where industry is coming forward to put these best practices, if you will, in place. And I think what we need to do is provide that line of sight to FDA and to others. Mr. Stupak. I asked the other panel, and I guess it was only I think the other panel said, the first panel, was a penny to print on the box the code. But like to implement this, do you have any cost estimates what would it cost to implement this? I mean that goes out the system I realize from farm to table, but. Mr. Giclas. Well, leafy greens there's a couple of different costs that are associated with it. There is a 2 cent per carton assessment levied on the industry to support the verification program and the administration of the leafy greens programs. That cost is borne by everybody but it is not--there are also additional costs for every individual firm in terms of ramping up to meet the requirements of the leafy greens metrics or best practices, if you will. And those have been estimated to be, you know, on the order of 25 cents a carton. There is the significant investment in this program. It has probably tripled through safety investments in California and doubled the number of staff that are focused on food safety. It is a very significant expenditure ultimately. Mr. Stupak. Dr. Brackett, do you have any estimates, or Restaurant Association estimates what something like this would cost if we had sort of like uniform standards throughout the nation, had to do it? I would take it you would be in favor of uniform standards maybe promulgated by the federal government, FDA, whatever, but let industry implement it to a minimum standard. And what would the cost estimates be, if you have any costs, Mr. Brackett? Mr. Brackett. Well, Mr. Chairman, I do not know what the cost is. We have been down that. Many of the industry already have systems in place already so they have already bought those costs, those systems already. But I agree with Mr. Taylor that having a performance-based system where the requirement is what the government expects or what the regulatory agency expects in terms of response in order to trace back and then allowing the industry to adopt to whatever the best technology is at the time is probably what we would support. Mr. Stupak. OK. Let me ask this, and whoever can answer it. Industry, like Jack In The Box, they had a problem one year. And they started putting in a system that made demand their growers do certain things. Some of the other, McDonald's I know do, and others. Has that worked? And what is the benefit of that as opposed to having the government put in something? Anyone want to comment on that? I mean I heard two things: number one, it can work. Even if the tomatoes are being grown in Mexico, if you are McDonald's you are a big enough corporate player you can say, you will do it this way, and get compliance even in a foreign country. And I have heard from other farmers who will say, well, these corporations while they are concerned about the safety of the food but they are putting other restrictions on us which are more risk management like fences and things like that, that have nothing to do with growing or protection. Can you shed a little light on that? Mr. Giclas, you are nodding your head? Mr. Giclas. Well, I would be happy to honor or to answer that part of the question. I am sorry. This has been a significant point of frustration for many, many growers. We have worked very, very hard and in close collaboration with the public health community to identify, you know, a set of best practices that we believe are prudent, science-based and feasible and implementable in the field. Those best practices are, you know, part of this program for leafy greens. And yet, there are individual buying companies that will say, for example, if you are estimating an approximate safe distance between a livestock operation and a produce operation, which you should keep separate---- Mr. Stupak. Right. Mr. Giclas [continuing]. We might say that a quarter mile is a safe distance. Or the distance may vary based on the risk; is it uphill, is it downhill, are there barriers in between that might, you know, prevent some escape of. Anyways, I guess the point is if we say a quarter mile and that has been vetted by science, there may be others who say a mile or 2 miles or 3 miles is better. Every single one of those new requirements has a cost to it. It takes valuable production land out of the equation and it jeopardizes people's ability to continue to farm. It may not be science based. So those are the kinds of things that we are dealing with with these extra requirements. Mr. Stupak. Professor Taylor? Mr. Taylor. Yes. Mr. Chairman, I was administrator of the Food Safety and Inspection Service---- Mr. Stupak. Right. Mr. Taylor [continuing]. For USDA in the aftermath of the Jack In The Box E. coli outbreak and saw what happened in the industry after that and also the efforts we made in the government to try to improve standards. And the first thing I would say is that, I mean Jack In The Box in particular, but also other major retailers went through enormous transformation in terms of their own management of their supply chain putting specifications on suppliers. The beef industry really got with that program and has gone through enormous positive change to bring technology into the processing. And I think they have made real progress, all based on the principle of preventive controls. And so industry innovation has been critical to progress on food safety. But the other side of that--Go ahead. Mr. Stupak. But then what happened to the beef industry? Because we had the largest recall ever, 143 million pounds of beef here. And we had a hearing on that. Mr. Taylor. Yes. Mr. Stupak. And I mean did it just get sloppy or what? Mr. Taylor. Part of the, well, one part of the reality is that the E. coli problem is not a problem you solve on one day and it stays solved. Mr. Stupak. Right. Mr. Taylor. Because that bacteria changes, it is a very dynamic problem. But the other point I wanted to make is that while innovation gets driven and really created in food safety by industry practices typically, there is an essential role for government regulation to set standards and ensure that it is not just the good actors who have the market incentive to do that, to make the changes, but that everybody makes. And that you bring the lower performers up to an acceptable, a socially acceptable level. And you also achieve the objective of having a common sense based standard so that their, you know, businesses can plan. And I think it would help probably address some of the concerns that Mr. Giclas raised. So again I think you have to look to both, you know, industry, private sector innovation to really drive progress, but then government standard setting and hopefully in a performance standard way so that, again, you see what is possible through innovation the industry itself has done and you set government performance standards to ensure that everybody meets that standard that has been demonstrated to be feasible. Mr. Stupak. Mr. Giclas, one more and my time is up. But, you know, Salinas Valley we have had, what, 20 outbreaks in 10 years. And why can we not seem to resolve that issue? It seems like every 9 months or so we have a spinach or a leafy problem with E. coli or Salmonella coming out of that particular area. If we have learned from all these different experiences why can we not solve that Salinas Valley problem? Any suggestions? I throw it out to all my panels. Mr. Giclas. Well, what I can say is that after the 2006 outbreak in spinach we really as an industry focused in on, you know, looking at these practices, what we could do. And now we have gone a full season without an outbreak. This program is in place. We are hopeful that this program has resolved these issues and this problem. As has been pointed out, you cannot get to zero but we can do everything we can to minimize. We think we have the best program in place to do that now. Mr. Stupak. All right, thanks. I guess only Dole and Natural Select are the only ones really aggressively doing the program that has been put forth by industry; right? In that spinach area in the Salinas Valley? Mr. Giclas. This program is subscribed to by 120 different companies I believe. Mr. Stupak. OK. Mr. Giclas. Representing 99.9 percent of the volume of---- Mr. Stupak. The Salinas Valley. Mr. Giclas. Yes. Mr. Stupak. OK. Mr. Burgess for questions, please. Mr. Burgess. I thank everyone's indulgence for what is turning into a very long afternoon. Professor Taylor, if I could just ask you, again I apologize for being absent for part of your testimony, but on the part where you discuss some of the problems within the food safety program at the FDA, and one of the things you allude to is that because of the bifurcated mission of the FDA, drugs and devices get more attention, and perhaps it is even the presence of a user fee that may drive attention in the direction of drugs and devices. I know we are going to have at some point the opportunity to discuss a draft here at some level at this committee, and I got a feeling that user fees are going to come up. So what is your feeling about the presence of user fees as it pertains to the food safety side of the FDA's bifurcated mission? Mr. Taylor. Well, I think I mean user fees on the drug side has served a very useful purpose of providing adequate funding for that drug review program. And that is now a program that has demonstrated that with adequate resources FDA can manage efficiently a timely drug review program. So it has worked in that sense. And my point in the testimony, of course, was that that has had a bit of a distorting effect, unintended, on management attention and the allocation of resources within FDA. And so user fees are a complicated issue and potentially a mixed blessing. On the food side, you know, I am of the old school that says that ideally we would fund public health programs through appropriated resources. And I think ideally that is what should happen. I---- Mr. Burgess. Just for the record, I agree with you. That is the fundamental purpose of the Food and Drug Administration and should be the fundamental purpose of our appropriations. Mr. Taylor. And I think philosophically that makes all the sense in the world. I think the issue though is in the world in which we live and in which you live, I mean how, the core issue for food safety is how do we provide an adequate, stable, predictable base of resources for FDA? That need for food safety at FDA, and that need has to be met. And so it may not be an ideal world and maybe there is a fee that could be done that will generate revenues. And I think I would personally be willing to compromise on the philosophy point if we could find a way to get a base of resources that was fair and not too onerous but would generate a sufficient, you know, core of resource for FDA so that it could do its work and, again, and maintain the independence and all that I think is important for its food safety public health function. Mr. Burgess. I will just ask if anyone else on the panel has a feeling about that, about what Professor Taylor just alluded to. I will tell you, philosophically I have difficulty with it. It is almost like we are abrogating our responsibility to provide the protection where it belongs which is within the food safety aspect of the FDA. But does anyone else have an opinion about that? Dr. Garren. We do not support user fees. We do, as you mentioned, believe that food safety is a common benefit to all and should be out of the general revenue fund and be appropriate to fund FDA so they can do their job. Mr. Burgess. Mr. Giclas, let me just ask you, you talked about a 1 to 2 cent charge for the tracking code on the box. In a sense that is a user fee, is it not? Mr. Giclas. It is, sir. It does fund the program. But the program is industry designed. It has industry at the heart of it in the sense of, you know, oversight on funding and spending and administration. ? So it is something that was willingly subscribed to. Mr. Burgess. And you can sleep peacefully at night knowing that 1 to 2 cents is not going to grow the government into some other aspect or some other place in your life. Mr. Giclas. Absolutely. Mr. Burgess. Very good. Dr. Brackett, let me just ask you a question on the--and we have heard a lot about this today from various sources, but what is the role for the food companies and the importers in the prevention of food-borne illness? Mr. Brackett. Well, it is the food companies that actually provide the safe food to the public. And it is their responsibility to actually make sure that those preventative controls that have been mentioned several times today are actually implemented. And I quite agree with Professor Taylor that it is the role of government to set those standards, and then if you allow the industry to actually meet those standards they will find ways to do that. Mr. Burgess. And then what, in the event of an outbreak or in the event of a problem what should the role be? Mr. Brackett. Well, I think the role should be to assist the regulatory agencies as much as they can. And again I would like to repeat what has been said elsewhere that if the regulatory agency and CDC do not have, either do not or do not have the ability to tap into the resources that the industry has in terms of scientific expertise and information I think they are missing the boat. Mr. Burgess. Let me ask a question in regards to what we have heard a lot about today in the 2002 Bioterrorism Act. And earlier we heard a lot from the standpoint of the importers. But as far as restaurants are concerned, the ability to opt out of the reporting and the recording requirements, in light of what we have learned with this outbreak and what we have learned today is it still reasonable to allow restaurants to opt out of the requirement when we have 130 people visiting these establishments every year? Dr. Garren. Thank you for the opportunity. We, while we are exempt from the Bioterrorism Act I would say that we are voluntarily complying now and that we keep the necessary records to know where we are getting product from. You know, I often say, you know, follow the money. I mean people know who they are buying product from. They have to pay the bills. And, you know, so they know that when FDA comes, even a small independent operator, it may be a paper-based system but they are maintaining those records because they have to financially to know who they are paying product to. So we would say that, you know, they are supplying the information needed to FDA. We need to come up with an approach and we welcome the opportunity to work with all the stakeholders, including federal and state food safety agencies and all the stakeholders along the supply chain to look at approaches that will work for all stakeholders involved, taking into account different business types, and in some cases taking into commodity types, because one-size-fits-all approach strategy may not work for everyone. Mr. Burgess. But in this instance would it not have been better if it was rather than voluntary compliance that it was required compliance? Dr. Garren. I would offer that in this particular case that, you know, the restaurants that were involved, even the small operators were able to supply the necessary information to facilitate a rapid response from them. FDA's ability to then go through and assess the amount of paperwork that they had to work through to build a case, you know, in regards to I guess collection of data, evidence and, you know, securing that information made a complicated and frustrating investigation. Again, we are, you know, willing to work with creating a program that works for all. Mr. Burgess. So it was more the FDA's inability to ask the correct question at the correct time of the correct person, not the inability of the small restaurant to provide the needed data when it was requested? Dr. Garren. They were supplying the information. And I think the earlier panels did indicate that, you know, we were looking down the wrong path too. So that also made the length of this outbreak, you know, they were supplying information on tomatoes. When asked about jalapeno peppers they quickly were able to supply the information needed to facilitate trace-back. Mr. Burgess. But realistically, how burdensome would it be to require the restaurants to participate in a trace-back system? Dr. Garren. You know, I do not know what the actual costs associated with that. And again, we would be willing to look at different strategies. I think if we are looking at the diversity of our industry you have a breadth of, you know, small independent operators collecting data on paper all the way through very sophisticated electronic tracking systems through the distribution chain, distributors that supply to our operators as well as large chains that have systems. We need to make sure that they take into account the different business types and we need to create a new system. Mr. Burgess. Mr. Giclas, let me ask you this because it came up during some of our other hearings where we were actually talking about food-borne illnesses in Asian countries. And the statement was made by one of the suppliers that if they found that one of their suppliers was providing a product that was somehow damaged that they didn't feel compelled to report it to other businesses in the area, this was just something they kept to themselves. And in fact they didn't even feel compelled to report it to the FDA who is responsible for ensuring the food safety. And the issue came up around the issue of maintaining a competitive advantage. Well, do you think members from your organization would be willing to sacrifice some or to provide some leniency on trade secrets, provide information, provide that collaborative role with public health officials in the event of an outbreak or during the course of an investigation? How closely held are those trade secrets and would you be willing to relax those somewhat during the course of an investigation of an outbreak? Mr. Giclas. Well, I think in the investigation of an outbreak the industry would comply fully and does comply fully with, you know, the requirements, the law. I mean in terms of learning from an outbreak I think we are all willing to sit down with FDA and others and share information, including what might be confidential business information. That is an individual company decision. But I mean I am certain that people would be willing to collaborate, you know, to improve on trace-back and to improve on those types of things. The leafy greens program that we have in California and Arizona if you are actually sourcing product from somebody who is not compliant that would be communicated to others so that they would know that there is a non-compliant supplier out there and not be able to--or not go to them to, you know, to source product if you will. So there are some additional preventive steps that are in place in this construct that we have for the leafy greens industry. Mr. Burgess. Thank you. And thank you, Mr. Chairman, for your indulgence. I actually if I could submit some questions in writing to the panel, just would like to get some follow-up on the issue of if we are ever able to close our border in the event of an outbreak, again the finding of this problem on a Friday morning and not being able to do anything about it for several days is pretty frustrating to the American people I think. Mr. Stupak. Sure, no problem. We will at the end there when we close out this hearing we will leave the record open for 30 days for additional written questions then. Mr. Burgess. Thank you. Mr. Stupak. Mr. Giclas, in the last question from Mr. Burgess you indicated sure we would like to sit down with the FDA if there was an outbreak and we would all share our records and the proprietary interests would probably be--it would not be burdensome. But I got the impression in listening to the three panels today, and especially Florida and California, like in this whole Salmonella Saintpaul no one ever sat down with the growers or producers to say we have this problem. We referred to it throughout today as an incident command. Like you think you would sit down with the growers, distributors, the wholesalers, the local health department, State health department and say, OK, where are we going with this? It seems like everything was stovepipe we call it the information was; this one does not talk here and that, and they use these ideas like Privacy Act, proprietary information as not to do that. I think the American people think that when you have an outbreak you are all sitting around a big table like we have in front of us saying, OK, where do we go? How do we do this? Could the tomatoes possibly come from Florida? Was it the growing season? I take it the industry would be willing to work and sit around a table and get this thing resolved instead of having it go on for a few months like we have now and 1,300 people becoming ill? Mr. Giclas. That is absolutely correct. I mean we would very much, and we have encouraged in other testimony and at other times setting up some type of a formal recognition of industry expertise to assist in trace-backs. And I can tell you, now having been involved in trace-backs for numerous commodities for a number of years, we have consistently asked FDA, tell us what went wrong. Tell us what is the obstacle in trace-back. Tell us what information you are missing, what form do you want it in. And we have yet to really get a response to those questions such that we can change our industry systems to meet their needs which is, I mean trace-back is vitally important to use because it minimizes the scope of the economic damages right away. Mr. Stupak. Sure. Thanks. Dr. Brackett, I guess it would only be fair to ask you. I asked some of the other panels on the Associated Press story that we have seen and we have talked a little bit about. And it in the binder there by Mr. Giclas, it is number 5 if you want to see it, but it was the article is entitled, ``Food Industry Bitten by its Own Lobbying Success.'' You were at the FDA at the time during the development of the regulations that resulted in the Bioterrorism Act which is designed to enhance product traceability; is that correct? Mr. Brackett. That is correct. Mr. Stupak. OK. In the article referring to the latest Salmonella outbreak investigation you are quoted as saying, ``If they,'' the regulations, ``had been broader and a bit more far-reaching it could have helped us.'' Is that correct? Mr. Brackett. Well, yes. That was the statement. And if I could, I would like to put it in context of what it was. Mr. Stupak. Sure. Mr. Brackett. And in fact there were two parts to that, one of which was something that I have said already today which is if it had included the agricultural industry, the farms, that would have helped a lot too. Mr. Stupak. Right. Mr. Brackett. And the second half is now, several years later, after technology has changed and the market has changed, if we had the ability to go back in a time machine and change things we could probably think of a way to fit this situation. But we do not have that sort of luxury. But the main part was the fact that the farm-to-table inclusion in the Bioterrorism Act would have been helpful. Mr. Stupak. OK. Anything else, Mr. Burgess? I have no further questions. I want to thank you for coming and thanks for your patience. Once in a while we get pulled out for votes, and I thought we were going to make it. We were pretty close to getting it all completed before the votes. Maybe we will start it earlier than 10:00 o'clock so we can get them in before votes. But thank you for being here. Thank you for your help. And I know Mr. Burgess will have further questions; we will submit them to you. I am sure other members will too. As I said earlier, there were two sets of hearings going on today besides oversight investigations. So thank you. That concludes all questions. I want to thank all of our witnesses for coming today and for their testimony. I ask for unanimous consent that the hearing record will remain open for 30 days for additional questions for the record. Without objection the record will remain open. I ask unanimous consent that the contents of our document binder be entered in the record. I also ask unanimous consent that the binder containing questionnaires used by the States and the CDC be made available for review at the committee office upon request. Without objection, the documents will be entered in the record and the consent or questionnaires will be in the office. [The information appears at the conclusion of the hearing] Mr. Stupak. That concludes our hearing. Without objection this meeting of the subcommittee is adjourned. [Whereupon, at 4:50 p.m., the subcommittee was adjourned.] [Material submitted for inclusion in the record follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]