[House Hearing, 111 Congress] [From the U.S. Government Publishing Office] THE ROLE AND PERFORMANCE OF FDA IN ENSURING FOOD SAFETY ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED ELEVENTH CONGRESS SECOND SESSION __________ MAY 6, 2010 __________ Serial No. 111-118 Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PRINTING OFFICE 76-573 WASHINGTON : 2012 ----------------------------------------------------------------------- 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�09512�091800, or 866�09512�091800 (toll-free). E-mail, [email protected]. COMMITTEE ON ENERGY AND COMMERCE HENRY A. WAXMAN, California, Chairman JOHN D. DINGELL, Michigan JOE BARTON, Texas Chairman Emeritus Ranking Member EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas RICK BOUCHER, Virginia 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 JOHN SHIMKUS, Illinois BART STUPAK, Michigan JOHN B. SHADEGG, Arizona ELIOT L. ENGEL, New York ROY BLUNT, Missouri GENE GREEN, Texas STEVE BUYER, Indiana DIANA DeGETTE, Colorado GEORGE RADANOVICH, California Vice Chairman JOSEPH R. PITTS, Pennsylvania LOIS CAPPS, California MARY BONO MACK, California MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon JANE HARMAN, California LEE TERRY, Nebraska TOM ALLEN, Maine MIKE ROGERS, Michigan JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma JAY INSLEE, Washington TIM MURPHY, Pennsylvania TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee ANTHONY D. WEINER, New York PHIL GINGREY, Georgia JIM MATHESON, Utah STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina CHARLIE MELANCON, Louisiana JOHN BARROW, Georgia BARON P. HILL, Indiana DORIS O. MATSUI, California DONNA M. CHRISTENSEN, Virgin Islands KATHY CASTOR, Florida JOHN P. SARBANES, Maryland CHRISTOPHER S. MURPHY, Connecticut ZACHARY T. SPACE, Ohio JERRY McNERNEY, California BETTY SUTTON, Ohio BRUCE L. BRALEY, Iowa PETER WELCH, Vermont Subcommittee on Oversight and Investigations BART STUPAK, Michigan, Chairman BRUCE L. BRALEY, Iowa GREG WALDEN, Oregon Vice Chairman Ranking Member EDWARD J. MARKEY, Massachusetts ED WHITFIELD, Kentucky DIANA DeGETTE, Colorado MIKE FERGUSON, New Jersey MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas MIKE ROSS, Arkansas DONNA M. CHRISTENSEN, Virgin Islands PETER WELCH, Vermont GENE GREEN, Texas BETTY SUTTON, Ohio JOHN D. DINGELL, Michigan (ex officio) 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. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement.............................. 3 Prepared statement........................................... 6 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement............................... 11 Hon. Robert E. Latta, a Representative in Congress from the State of Ohio, opening statement..................................... 12 Prepared statement........................................... 13 Hon. Joe Barton, a Representative in Congress from the State of Texas, prepared statement...................................... 87 Witnesses Michael R. Taylor, Deputy Commissioner for Foods, Food and Drug Administration; Accompanied by Steven M. Solomon, Assistant Commissioner for Compliance Policy, Office of Regulatory Affairs, Food and Drug Administration.......................... 16 Prepared statement........................................... 19 Answers to submitted questions............................... 90 Lisa Shames, Director, Agriculture and Food Safety, Government Accountability Office.......................................... 37 Prepared statement........................................... 39 Jodi Nudelman, Regional Inspector General for Evaluation and Inspections, Region II, Health and Human Services Office of Inspector General.............................................. 63 Prepared statement........................................... 65 THE ROLE AND PERFORMANCE OF FDA IN ENSURING FOOD SAFETY ---------- THURSDAY, MAY 6, 2010 House of Representatives, Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, Washington, DC. The subcommittee met, pursuant to call, at 2 p.m., in room 2123, Rayburn House Office Building, Hon. Bart Stupak (chairman of the subcommittee) presiding. Present: Representatives Stupak, Christensen, Dingell (ex officio), Waxman (ex officio), Burgess, and Latta. Staff Present: Phil Barnett, Staff Director; Bruce Wolpe, Senior Advisor; Eric Flamm, FDA Detailee; Dave Leviss, Chief Oversight Counsel; Stacia Cardille, Counsel; Erika Smith, Professional Staff Member; Scott Schloegel, Investigator; Ali Neubauer, Special Assistant; Derrik Franklin, HHS-OIG Detailee; Karen Lightfoot, Communications Director, Senior Policy Advisor; Elizabeth Letter, Special Assistant; Mitchell Smiley, Special Assistant; Melissa Bartlett, Minority Counsel, Health; Kevin Kohl, Minority Professional Staff Member; Ruth Saunders, Minority Detailee; and Alan Slobodin, Chief Counsel, Oversight. 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 entitled, ``The Role and Performance of FDA in Ensuring Food Safety.'' The chairman, ranking member, and chairman emeritus will be recognized for a 5-minute opening statement. Other members of the subcommittee will be recognized for a 3-minute opening statement. I will begin. Today's hearing will mark the 12th hearing of the Oversight and Investigations Subcommittee since January 2007 regarding food safety issues. We have examined an E. coli outbreak traced to tainted spinach, melamine-contaminated pet food, and the industry practice of intentional exposure of meat and seafood to carbon monoxide, among other inquiries. During this Congress, the subcommittee has held hearings on a salmonella outbreak associated with peanut products manufactured by the Peanut Corporation of America; and actions and obligations of food manufacturers and retailers that purchased tainted food products; and the safety of bottled water. Today, we will continue our oversight role and performance in the food safety system by considering two reports. The first is a Government Accountability Office report entitled, ``Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Foods.'' GAO found that, despite the efforts and actions of the three Federal agencies that share jurisdiction over imported food--U.S. Customs and Border Protection, the U.S Department of Ag's Food Safety and Inspection Service, and the U.S. Food and Drug Administration--there are gaps in the enforcement and collaboration that could allow high-risk foods to enter domestic commerce without assurance that products are safe. Specifically, the GAO found: the three agencies failed to collaborate and to share food-related data effectively; FDA's authority to ensure importer compliance is limited; the agencies lacked the ability to assign unique identification numbers for importing firms; and CBP faces challenges managing inbound shipments. The second report, ``FDA Inspections of Domestic Food Facilities,'' was issued by the Department of Health and Human Services, Office of the Inspector General. The report identifies a number of challenges confronting FDA in safeguarding domestically produced food. OIG found that, on an average, FDA inspects only 24 percent of domestic food facilities annually and that the number of inspections declined from 2004 to 2008. The report also found that FDA has not inspected 56 percent of the food facilities under its jurisdiction during the past 5 years. The inspector general found that, and I quote, ``When violations were identified, FDA did not routinely take swift and effective action to ensure that these violations were remedied,'' end of quote. Additionally, the report found that some companies who had violations at their facilities significant enough to warrant regulatory action refused to grant FDA inspectors access to their official records. I am interested in learning more about these two reports and what proactive steps the GAO and inspector general believes FDA could be taking to ensure the safety of our Nation's food supply. I am also interested in hearing from FDA on the recent steps it has taken to reinvigorate its focus on food safety and to improve and enhance food safety oversight. The work of this subcommittee, coupled with the work of the Health Subcommittee and the full committee on food safety, culminated the introduction and passage of H.R. 2749, the Food Safety Enhancement Act, which passed the House of Representatives on July 30th, 2009. The provisions contained in H.R. 2749 would address several concerns raised by GAO. For example, Section 204 of the bill requires all food importers to register with FDA annually, comply with good importer practices, and pay a registration fee of $500 in order to ship food to the United States. Section 206 requires that registered facilities have a unique facility identifier or they will not be allowed to import food into the country. I am interested in hearing from our witnesses how H.R. 2749 could help address the concerns raised in the two reports before us today. Our witnesses today include the authors of the two reports. Lisa Shames is the director of the agriculture and food safety at the Government Accountability Office. Jodi Nudelman is the regional inspector general for evaluation and inspections for Region II at the U.S. Department of Health and Human Services, Office of Inspector General. Joining them on the panel will be Mike Taylor, FDA deputy commissioner for foods, and Steve Solomon, deputy assistant commissioner for compliance policy, from the Food and Drug Administration. The members of this subcommittee were the first to sound the alarm on the weaknesses of our food safety system. I look forward to hearing from our witnesses today about progress that has been made since we began pushing for reform more than 3 years ago and about the weaknesses that remain until we have an effective food safety bill enacted into law. We are fortunate that today's hearing was prompted by the HHS and GAO reports rather than another widespread food outbreak like we saw with the spinach in 2007, peppers in 2008, and peanut butter in 2009. But make no mistake about it: Without legislative action, it is not a matter of if but when more lives will be put at risk by another outbreak. We cannot afford to put off action any longer. Mr. Burgess, opening statement, please? OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Burgess. I thank the chairman for the recognition. And I am pleased to join you and the other members on the committee as we convene this hearing on the role of the Food and Drug Administration to ensure food safety for the American public. Food safety reform is relatively controversial, yet a critical issue, competing for attention with a long list of domestic priorities. Last July, in a bipartisan fashion, the House passed food safety legislation. I supported the legislation because, while historically the performance of the FDA has been questioned, I felt this was partly a result of inadequate tools. But the enduring role of the Food and Drug Administration today still remains a very complex question. The House legislation did not address the future progress of future inspection and whether or not it is the proper role of both the Food and Drug Administration and the United States Department of Agriculture to continue their bifurcated jurisdiction over food. We heard, for instance, that a food such as pizza if it has only cheese on it is wholly the province of the Food and Drug Administration, whereas if it has pepperoni as well, it is in the province of the U.S. Department of Agriculture. One thing is crystal-clear without controversy: The future of the FDA should not be as a reactive body dictated by the events of yesterday, but rather an effective and efficient, proactive agency preventing the emergencies of tomorrow. And I agree wholeheartedly with the chairman of this subcommittee when he says it is not a question of if but when. Because, as we were coming into the room for this hearing today, across the newswire from the Columbus Dispatch, Federal health officials will come to Columbus this weekend to help determine what is responsible for a three-State E. coli outbreak that has sickened at least seven people there. So, as we see, even tomorrow's headlines today are being covered in this committee. It is important for the Food and Drug Administration as well as the industry to work cooperatively to reduce the number of and help prevent food-borne illnesses and contamination before the tainted products are able to enter the markets. The Food and Drug Administration should make maximum use of information technologies for risk assessment, but it has come to my attention and the attention of the committee that the Food and Drug Administration has delayed the rollout of the promising new system, PREDICT. PREDICT uses a variety of assessments to rank food import shipments according to risk. The system is currently in use in New York and Los Angeles, but the nationwide deployment was recently postponed indefinitely because of technical problems. And this is not the first time that we have heard of the failure of the Food and Drug Administration to keep pace with changes in technology. From the failures of the 510(k) medical device process to the backlog of new drug applications to the entire portfolio of food issues, the Food and Drug Administration regulates fully 25 percent of all government activity, yet the Food and Drug Administration remains technologically in the 1990s. This is why scientific innovation and information technology must play a central role in the prevention and the strategic analysis that is essential to a successfully functioning Food and Drug Administration. We are going to hear from four witnesses today, including two from the agency itself. And although much has been said about the past limitations of the agency and the uptick in funding shortfalls from a year ago, I do not believe that it is simply a resource question and that simply increasing the resources of the Food and Drug Administration will solve the problems outlined before us today. After numerous hearings, we have learned that simply providing more money to FDA will not, by itself, result in a safer food supply. From our agricultural imports to domestic manufacturing, the Food and Drug Administration must streamline the process and internal controls to identify high-risk products and manufacturers before tainted goods are able to enter the food supply. While continuing to collaborate with their counterparts at the USDA and the Customs and Border Protection, the Food and Drug Administration internal communications between Washington and their regional offices at home and abroad must be increased. Communication may not create the perfect system, but it will create a more reliable and a more efficient one. I am also interested in an update of the issues that still hinder work of the FDA and any new ideas you may have to foster innovation to improve the agency as a whole. As Commissioner Hamburg recently said, it is simply not possible for FDA to inspect our way to safety. Congress must advocate for an all-of-the-above approach in addressing food safety solutions. We must support and advocate for the FDA to continue to advocate for risk-based approaches to the inspection and testing processes, as well as support improvements to modernize scientific standards, safety controls, and information technology. While these update reports from the Government Accountability Office and from Health and Human Services Inspector General are helpful, their reports do not change the conversation regarding this domestic priority. Food safety is important. Food safety legislation has passed the House. Food safety is now awaiting Senate action. So I hope today's hearing is not just to continue to put pressure on the Senate to act for food safety. It is my understanding that the Senate is already planning to vote on this issue as soon as the Financial Services bill is finished. I hope, instead, we also ask questions about whether the progress and the evolution of food safety requires more advancements than red-tape bureaucracy than the government will logically allow. I would like to thank the chairman again, and I look forward to the testimony of our witnesses and to our questions. I will yield back. [The prepared statement of Mr. Burgess follows:] [GRAPHIC] [TIFF OMITTED] T6573A.001 [GRAPHIC] [TIFF OMITTED] T6573A.002 [GRAPHIC] [TIFF OMITTED] T6573A.003 [GRAPHIC] [TIFF OMITTED] T6573A.004 [GRAPHIC] [TIFF OMITTED] T6573A.005 Mr. Stupak. Thank you, Mr. Burgess. Mr. Waxman, full committee chairman, opening statement please, sir? OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Mr. Waxman. Thank you very much, Mr. Chairman. I want to commend you for calling this important hearing and to examine the role of FDA in protecting the Nation's food supply. Today we are going to hear from two reports, one from GAO, the other from HHS Inspector General, about the FDA performance. These two reports tell a story of an agency that is trying to keep the food supply safe but needs new authorities, more effective tools, and increased funding to meet its obligation. In GAO's report, it found that FDA needs to coordinate its enforcement efforts better with other agencies. For example, FDA and Customs and Border Protection should be able to work together to assign a unique identification number to firms that import our food. This is currently not the case. In fact, there are some that have more than three identifiers, and GAO found one firm had 75. These multiple identifiers make it more difficult for FDA to track foods that are imported. GAO also questioned whether FDA's current penalties are sufficient to keep an importer from violating FDA requirements. The OIG report focused on FDA's inspection of domestic food facilities. They found that FDA inspected only 24 percent of food facilities each year between 2004 and 2008. The number of FDA inspections declined during that time, even as the number of facilities increased. Over the course of 5 years, FDA failed to inspect 56 percent of facilities that were subject to its authority and only inspected an additional 14 percent. These two reports are very disturbing. It is a similar story to what we heard last year. We were told in the two hearings on salmonella outbreak in peanut butter that sickened over 700 people--and the investigators revealed executives at the Peanut Corporation of America knew their peanuts were testing positive for salmonella, but they chose to ship the tainted food anyway. Many of the concerns raised in these two reports and in the wake of the salmonella outbreak are addressed by the Food Safety Enhancement Act of 2009, which the House passed on a bipartisan basis. The legislation contains critical fixes. I am pleased that we are holding this important hearing. I hope the Senate will act soon and we will have this new legislation in place. And I hope we will see, through the efforts of legislation and oversight, a more comprehensive food safety regimen at FDA. Thank you for holding the hearing. I yield back my time. Mr. Stupak. Thank you, Mr. Chairman. Mr. Latta for 3 minutes? We will try to get them in. OPENING STATEMENT OF HON. ROBERT E. LATTA, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO Mr. Latta. Well, thank you very much, Mr. Chairman and Ranking Member Burgess. First of all, thanks for holding this subcommittee hearing on the Food and Drug Administration ensuring food safety. And it is also an honor being recently appointed on the Energy and Commerce Committee, and I look forward to working with you on the important issues that come before the Oversight and Investigations Subcommittee. Instances of contaminated food products are a serious concern for the public. Just last week, the FDA announced that contaminated materials were used in production of several lots of pediatric Tylenol products. About 1,500 lots of the bottled products are currently being recalled. Furthermore, as the percentage of U.S. food supply imported from foreign countries increases and bioterrorism continues to be a threat, food safety is a critically important issue. Last summer, the House debated H.R. 2749, the Food Safety Enhancement Act, and it is expected that the Senate will soon take action on the legislation. I represent the largest agricultural district in the State of Ohio and am a member of the House Agriculture Committee. I believe that H.R. 2749 did not adequately address the concerns of the agricultural community, nor was it referred to the Agriculture Committee at that time for any hearings. Additionally, the Congressional Budget Office estimates that H.R. 2749 will authorize $2.314 billion over fiscal years 2010 through 2014 and that it will take $3.5 billion for the FDA to administer the new regulatory activities under the legislation at that time. The spending level authorized by H.R. 2749 is of grave concern, especially when the September 2009 GAO report found that gaps in enforcement and collaboration currently undermine food safety efforts among Customs and Border Patrol, the FDA, and USDA's Food and Safety Inspection Service. Furthermore, the same report indicates there is a lack of information sharing between the FDA and States during a recall, which impedes States' efforts to quickly remove contaminated food. The safety and security of the Nation's food supply is of utmost importance; however, with 15 Federal agencies already administering at least 30 Federal laws concerning food safety, I am concerned of the prospect of an increased size in the bureaucracy, budget, and statutory authority for the FDA when improvements in communication, collaboration, and technology have been recommended by the GAO. Mr. Chairman, I thank you for this opportunity. I look forward to hearing the testimony from the witnesses on the panel today. And I yield back. [The prepared statement of Mr. Latta follows:] [GRAPHIC] [TIFF OMITTED] T6573A.006 [GRAPHIC] [TIFF OMITTED] T6573A.007 Mr. Stupak. Thank you, Mr. Latta. Good to have you on board. Look forward to working with you. Mrs. Christensen for 3 minutes, please? Mrs. Christensen. Thank you. I will try to be shorter than that. Every year, 300,000 people in this country are hospitalized and 5,000 die after consuming contaminated food or beverages. So thank you, Chairman Stupak and Ranking Member Burgess, for following up on this issue. It is very important that we explore the weaknesses in the food safety network and the coordination, or lack of it, between CBP, FSIS, and FDA, as well as any new authorities these agencies might need. So I just look forward to hearing the testimony of our witnesses and to working with the subcommittee and the larger committee to address the gaps in our food safety system. And thank you, Chairman Stupak, once again, for holding this hearing on this issue that is really vital to the safety and health of everyone who lives in this country. Mr. Stupak. Well, thank you. And we have 2 minutes left to vote. We have a series of votes. There are four votes, plus a motion to recommit. So we are going to stand in recess until 3:15. So this committee will be in recess until 3:15. [Recess.] Mr. Stupak. The committee will come to order. Mr. Dingell, do you have an opening statement, sir? Mr. Dingell. Mr. Chairman, I will dispense with my opening statement. I thank you. Mr. Stupak. Very good. Then that concludes the opening statements by members of the subcommittee. I call our first panel. On our first panel we have Mr. Michael Taylor, deputy commissioner for foods with the Food and Drug Administration; accompanying him is Mr. Steven Solomon, assistant commissioner for compliance policy at the Food and Drug Administration; Lisa Shames, director of agriculture and food safety at the Government Accountability Office; and Ms. Jodi Nudelman, regional inspector general for evaluation and inspections for the Health and Human Services Office of Inspector General. We welcome you all. It is the policy of this subcommittee to take all testimony under oath. Please be advised that you have the right, under the rules of the House, to be advised by counsel during your testimony. Do you wish to be represented by counsel? Everyone is shaking their head ``no,'' so I will take it as no. Please then rise, raise your right hand, and take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect the witnesses replied in the affirmative. You are now under oath. We are going to begin with your opening statement of 5 minutes, please. If you would like to submit a longer statement for the record, it would be accepted. Mr. Taylor, shall we start with you? TESTIMONY OF MICHAEL R. TAYLOR, DEPUTY COMMISSIONER FOR FOODS, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY STEVEN M. SOLOMON, ASSISTANT COMMISSIONER FOR COMPLIANCE POLICY, OFFICE OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION; LISA SHAMES, DIRECTOR, AGRICULTURE AND FOOD SAFETY, GOVERNMENT ACCOUNTABILITY OFFICE; JODI NUDELMAN, REGIONAL INSPECTOR GENERAL FOR EVALUATION AND INSPECTIONS, REGION II, HEALTH AND HUMAN SERVICES OFFICE OF INSPECTOR GENERAL TESTIMONY OF MICHAEL R. TAYLOR Mr. Taylor. Yes, sir. Good afternoon, Mr. Chairman, Ranking Member Burgess, and members of the subcommittee. I am pleased to be here today with my colleague, Dr. Steven Solomon, and to have this chance to talk with the committee about FDA's food safety program. I also want to really thank you, Mr. Chairman, as well as Chairman Dingell, Chairman Waxman, and all the members of the committee, for your leadership in passing the Food Safety Enhancement Act, which we do hope will soon go to conference with the bill now pending in the Senate. As you know, food safety is an important priority for the Obama administration. Soon after taking office, the President established a Food Safety Working Group which brought together experts from all Federal agencies with responsibilities related to food safety. In its July 2009 report, the working group recognized the challenges posed by a rapidly changing and globalized food supply and the need to shift our focus to preventing food safety problems throughout the system. The working group also recognized the importance of inspections, recommending that the government prioritize crucial inspection and enforcement activity, build on and enhance State and local food safety efforts, and utilize better data to guide these efforts and evaluate their outcomes. In August of 2009, Commissioner Margaret Hamburg created my office, the Office of Foods, to lead a unified FDA foods program and to enhance FDA's ability to meet today's challenges in food safety. We recently launched the One Mission, One Program initiative, which involves over 100 experts from throughout FDA who are addressing topics crucial to the future success of the foods program and the implementation of the anticipated new legislation. This includes an inspection and compliance strategy group that is looking hard at the way we conduct inspections. FDA's food safety inspections have focused traditionally on identifying sanitation, manufacturing, and product contamination problems in food facilities and gathering evidence of regulatory violations for use in possible enforcement cases. These efforts have contributed significantly to food safety over the years, but the preventive control requirements and other new tools provided by H.R. 2749 would greatly enhance the ability of FDA investigators and FDA inspections to protect public health. We will, of course, continue to act to remove contaminated food from commerce, but our focus will shift from collecting evidence of food safety problems after they have occurred to ensuring that food companies are doing what is necessary to prevent problems in the first place. Our goal needs to be high rates of compliance with the prevention-oriented standards envisioned by H.R. 2749. And to achieve this, we envision our investigators conducting a wider array of inspection activities than is common today and targeting those activities in ways that get the maximum compliance and public health bang for the buck. The recent Office of Inspector General report on domestic inspections is a useful snapshot of FDA's food safety system as it has existed in recent years. OIG has identified areas of opportunity for enhancing FDA's enforcement authority, and FDA has already addressed many of the issues noted in the report. For instance, improving the speed and predictability of follow-up to inspections and strengthening the agency's enforcement program are top agency goals. Last August, Commissioner Hamburg announced six initiatives to ensure that enforcement actions taken by the agency are swift, aggressive, and will have a positive impact on public health. FDA appreciates OIG's recognition of the gaps in the agency's inspection authority, and we support their legislative recommendations. These include the use of civil monetary penalties for FD&C Act violations related to food and the authority provided in Section 106 of H.R. 2749 for routine access to all records bearing on whether a food may be in violation of the act. The GAO report of September 2009 raised some important issues relating to the safety of imported food. The agency agrees with many of GAO's recommendations, and we are working to incorporate them into both short-term and long-term initiatives. The report looked at FDA's new PREDICT system for targeting import shipments. This technology, which is deployed in Los Angeles and New York, will improve import screening and targeting to better prevent the entry of unsafe foods and expedite the entry of non-violative foods. A pilot test of the prototype system showed that PREDICT works to target shipments that are more likely to be found violative when examined by FDA. FDA has encountered problems with rolling out PREDICT nationwide due to difficulties with incorporating it into the agency's outdated IT infrastructure, which is now undergoing major upgrades. These problems have delayed the full deployment of PREDICT, but we will continue to move forward as expeditiously as possible, with full roll-out anticipated by the end of the year. And we will continue to evaluate and strengthen PREDICT as the project progresses. FDA was encouraged that GAO recognized the importance of new legislative authorities as a key to strengthening FDA's oversight of imported foods. In accordance with GAO's recommendations, FDA is working with Congress to obtain authority for civil money penalties and to acquire the use of a unique identifier by food facilities, both of which are provided by H.R. 2749. The House bill will provide other valuable tools for ensuring that importers reliably verify--and this is really important--reliably verify that the foods they import are produced in accordance and compliance with the same prevention- oriented standards that we would make applicable to foods produced in the United States. We all know that for our food safety system to be effective, prevention must begin at the point of production, not at the port of entry. Mr. Chairman, protecting our Nation's food supply remains a top priority for FDA and the administration. We really are at a historic moment for food safety in the United States. As we work collaboratively to improve our authorities, our practices, and our policies, it will enable us to meet the food safety challenges of the 21st century. And we appreciate the support of this committee and look forward to working with you in the future. Thank you. [The prepared statement of Mr. Taylor follows:] [GRAPHIC] [TIFF OMITTED] T6573A.008 [GRAPHIC] [TIFF OMITTED] T6573A.009 [GRAPHIC] [TIFF OMITTED] T6573A.010 [GRAPHIC] [TIFF OMITTED] T6573A.011 [GRAPHIC] [TIFF OMITTED] T6573A.012 [GRAPHIC] [TIFF OMITTED] T6573A.013 [GRAPHIC] [TIFF OMITTED] T6573A.014 [GRAPHIC] [TIFF OMITTED] T6573A.015 [GRAPHIC] [TIFF OMITTED] T6573A.016 [GRAPHIC] [TIFF OMITTED] T6573A.017 [GRAPHIC] [TIFF OMITTED] T6573A.018 [GRAPHIC] [TIFF OMITTED] T6573A.019 [GRAPHIC] [TIFF OMITTED] T6573A.020 [GRAPHIC] [TIFF OMITTED] T6573A.021 [GRAPHIC] [TIFF OMITTED] T6573A.022 [GRAPHIC] [TIFF OMITTED] T6573A.023 [GRAPHIC] [TIFF OMITTED] T6573A.024 [GRAPHIC] [TIFF OMITTED] T6573A.025 Mr. Stupak. Thank you. Mr. Solomon, do you have anything to add? Mr. Solomon. No, thank you. Mr. Stupak. Ms. Shames, would you like to do an opening statement? TESTIMONY OF LISA SHAMES Ms. Shames. Yes, thank you. Chairman Stupak, Ranking Member Burgess, and members of the subcommittee, I am pleased to be here today to discuss FDA's oversight of imported food. Effective FDA oversight is critical to public health. About 60 percent of fresh fruits and vegetables and 80 percent of seafood are imported. My testimony today will focus on three key issues: FDA's overseas inspections of imported food; gaps in import enforcement; and statutory authorities that could further help FDA. First, regarding the inspections: The number of FDA's overseas inspections has fluctuated since 2001. As shown in Table 1, annual inspections ranged from 95 to 153 out of an estimated 189,000 foreign firms. These inspections were conducted in 56 countries, mostly in Mexico. FDA conducted 46 inspections in China during this time frame. To augment these inspections, FDA has opened offices in China, Costa Rica, and India and plans to open more in Mexico, Chile, the Middle East, along with the European Union. In addition, PREDICT, a risk-based computer program is to assist FDA inspectors flag higher-risk food shipments. As Mr. Taylor said, a pilot test of PREDICT was promising. PREDICT nearly doubled the percentage of field examinations that resulted in violations. However, FDA told us that PREDICT's nationwide roll-out has been delayed, primarily because of technical problems. Second, we identified several gaps in enforcement that could allow food with safety violations to enter U.S. commerce. One gap is that FDA has limited authority to assess civil penalties on violators. Importers post a monetary bond for shipments to provide assurance that they meet U.S. requirements. However, even though the bond may be up to three times the value of the shipment, this sum may be negligible for a large importer. An unscrupulous importer may consider forfeiting the bond as a part of the cost of doing business. FDA agreed with our recommendation that it seek authority to assess penalties. We note that H.R. 2749 provides for assessing penalties. A second gap is the lack of unique identification numbers. Importers get computer-generated ID numbers from FDA. Because importers may provide their names and addresses slightly differently for each shipment, multiple identifiers are generated. FDA officials told us that firms have, on average, three unique identifiers, and one firm had 75. In addition, foreign firms are to register with FDA and are assigned a registration number, as well. FDA told us that there may be duplicate registration numbers, as well. FDA agreed with our recommendation to pursue the use of specific identifiers. H.R. 2749 also provides for such a unique identifier system. A third gap is that FDA does not share product distribution lists with States during a food recall because the information is considered commercially confidential. State officials told us that, without this information, they lose time removing recalled food from grocery shelves. FDA agreed with our recommendation to find ways to share information to the States. On a positive note, one gap we found appears to be resolved. We were told that FDA now receives the arrival time of imported food shipments. This can help FDA coordinate any further review for high-risk imports. Finally, we have made several recommendations that would help FDA improve food safety oversight. GAO has called for mandatory food recall authority. Currently, food recalls are voluntary, and FDA has no authority to compel companies to recall contaminated foods except for infant formula. Other government agencies that regulate other products, such as toys or car tires, have recall authority and have had to use it when companies did not cooperate. FDA should also strengthen its oversight of food ingredients determined to be generally recognized as safe, or GRAS. Companies may conclude a substance is GRAS without FDA's approval and even without its knowledge because companies are not required to inform FDA. FDA generally agreed with our recommendation that it develop a strategy to require companies to provide basic information about their GRAS determinations and, in view of emerging science, to conduct reconsiderations of GRAS ingredients. We also recommended that FDA seek any statutory authority that the agency determines it needs to implement our recommendations. And, lastly, FDA agreed with our recommendation that it seek authority to issue regulations for preventive controls for high-risk food. As Mr. Taylor said, FDA already has regulations for preventive controls for seafood and juice which require firms to analyze safety hazards and implement plans to address those hazards. FDA officials told us that issuing regulations for preventive controls might be one of the most important things that they can do to enhance the oversight of fresh produce. We note that H.R. 2749 contains provisions that address mandatory recall, GRAS ingredients, and preventive controls. In conclusion, a substantial volume of our food supply is imported. Our work has shown that FDA could strengthen its oversight of imported food and close gaps in its enforcement by assessing penalties, developing unique identifiers, and sharing information with State agencies. Additional statutory authorities to conduct a mandatory recall and to establish preventive controls could further help FDA's food safety. Mr. Chairman, this concludes my prepared statement, and I would be happy to answer any questions that you or other members of the subcommittee may have. Thank you. [The prepared statement of Ms. Shames follows:] [GRAPHIC] [TIFF OMITTED] T6573A.026 [GRAPHIC] [TIFF OMITTED] T6573A.027 [GRAPHIC] [TIFF OMITTED] T6573A.028 [GRAPHIC] [TIFF OMITTED] T6573A.029 [GRAPHIC] [TIFF OMITTED] T6573A.030 [GRAPHIC] [TIFF OMITTED] T6573A.031 [GRAPHIC] [TIFF OMITTED] T6573A.032 [GRAPHIC] [TIFF OMITTED] T6573A.033 [GRAPHIC] [TIFF OMITTED] T6573A.034 [GRAPHIC] [TIFF OMITTED] T6573A.035 [GRAPHIC] [TIFF OMITTED] T6573A.036 [GRAPHIC] [TIFF OMITTED] T6573A.037 [GRAPHIC] [TIFF OMITTED] T6573A.038 [GRAPHIC] [TIFF OMITTED] T6573A.039 [GRAPHIC] [TIFF OMITTED] T6573A.040 [GRAPHIC] [TIFF OMITTED] T6573A.041 [GRAPHIC] [TIFF OMITTED] T6573A.042 [GRAPHIC] [TIFF OMITTED] T6573A.043 [GRAPHIC] [TIFF OMITTED] T6573A.044 [GRAPHIC] [TIFF OMITTED] T6573A.045 [GRAPHIC] [TIFF OMITTED] T6573A.046 [GRAPHIC] [TIFF OMITTED] T6573A.047 [GRAPHIC] [TIFF OMITTED] T6573A.048 [GRAPHIC] [TIFF OMITTED] T6573A.049 Mr. Stupak. Thank you. Ms. Nudelman, your opening. TESTIMONY OF JODI NUDELMAN Ms. Nudelman. Good afternoon, Chairman Stupak, Ranking Member Burgess, and other members of the subcommittee. I am Jodi Nudelman, regional inspector general in New York for the U.S. Department of Health and Human Services Office of Inspector General. I appreciate the opportunity to appear before you today to discuss our most recent review of FDA's food inspections program. FDA's inspections are an important tool for ensuring food safety. Recent outbreaks, however, such as the salmonella outbreak caused by peanuts in 2009, have raised questions about FDA's inspection process and its ability to protect the Nation's food supply. Our most recent review focused on FDA's inspections of domestic food facilities. In brief, our review found that more than half of food facilities went 5 or more years without an inspection. We also found that the number of FDA inspections is going down, even as the number of food facilities is going up. In 2004, FDA inspected over 17,000 facilities. In 2008, this number dropped to fewer than 15,000. The number of high-risk facilities inspected also declined during this time. If FDA does not routinely inspect food facilities, it cannot be sure that these facilities are complying with the law and that the food they handle is safe. Our review also found that FDA's inspectors are identifying fewer violations in food facilities. During an inspection, an inspector may find violations of FDA's regulations or laws. Based on the nature of the violations, he or she may assign the facility a classification. In the most severe cases, the inspector will assign the facility an OAI classification, which means ``official action is indicated.'' Between 2004 and 2008, the number of facilities that received OAI classifications dropped from about 600 to less than 300. Most commonly, facilities received OAI classifications for unsafe practices and unsanitary conditions in the facility. These classifications resulted from violations such as food not being adequately refrigerated or evidence of rodent infestation. We also found that nearly three-quarters of the facilities that received OAI classifications had a history of violations. Even more concerning, half of these facilities had been cited for the exact same violation in a prior inspection. Further, our report found that FDA did not always take swift and effective action to remedy the violations. When a facility receives an OAI, FDA should consider taking some type of regulatory action. In the year that we studied, FDA took regulatory action against 46 percent of the facilities that received OAIs. For the remaining, FDA either lowered the classification or took no regulatory action. Moreover, for a third of the facilities with OAIs, FDA did not take additional steps to ensure that the violations were corrected. This means that FDA did not reinspect these facilities in a timely manner or review any other evidence to determine whether the violations were corrected. Based on these findings, we made six recommendations to FDA. We recommended that FDA increase the frequency of its inspections, especially its high-risk inspections; provide additional guidance about when to lower OAIs; take appropriate action against facilities with OAIs; ensure that violations are corrected; seek the authority to access facilities' records during an inspection; and, finally, consider seeking the authority to impose civil penalties through administrative proceedings. In conclusion, our report identified significant weaknesses in FDA's inspections program. We found that many food facilities go without routine inspections. We also found that, when FDA finds violations, it does not always take swift and effective action to ensure that the violations are remedied. Taken together, our findings demonstrate that more needs to be done to protect public health and to ensure that FDA has the necessary tools to keep food safe. This concludes my testimony, and I welcome your questions. [The prepared statement of Ms. Nudelman follows:] [GRAPHIC] [TIFF OMITTED] T6573A.050 [GRAPHIC] [TIFF OMITTED] T6573A.051 [GRAPHIC] [TIFF OMITTED] T6573A.052 [GRAPHIC] [TIFF OMITTED] T6573A.053 [GRAPHIC] [TIFF OMITTED] T6573A.054 [GRAPHIC] [TIFF OMITTED] T6573A.055 Mr. Stupak. Thank you. And thank you to all the witnesses for your testimony. And let me just apologize. We got tied up on the floor. I thought we would be back by 3:15. It was about a half-hour later. You never know what happens when you get to the floor. We will now move to questions. Mr. Taylor, let me ask you this. The FDA announced a lettuce recall today. Freshway Foods is doing a voluntary recall of shredded romaine lettuce with a use on date by May 12th--or use on or before May 12th. I guess three people have been hospitalized. In the trace-back, do we have any idea of where that romaine is originating from? Mr. Taylor. Our understanding of the investigation so far is it came from a production site in Arizona, in Yuma, Arizona, where this company had its growing operations. We don't know the cause of contamination, but we do know that there was product contaminated, people got sick. And so this recall is highly appropriate to protect the public health. Mr. Stupak. Is the lettuce strictly grown in Arizona, or is it mixed with lettuce from Mexico, as we have seen in the past? Mr. Taylor. Well, this is romaine that is grown just in Arizona. And it is sold to institutions in a bulk sort of form, is the general way in which this product is distributed. Mr. Stupak. If I remember correctly, when we were out in California, you were there with us, and we were doing some of the farming there. And I thought Arizona and California had a very good trace-back method. You could almost tell from what field it came from. Would you care to comment on this in the matter of this case? Mr. Taylor. Well, in this case, once we had the company identified, there was not a problem getting back to the source of production. Mr. Stupak. OK. So the production field produced right there, and you don't know if it is in machinery or whether it was the growing site. Mr. Taylor. We don't know--yes, we are investigating, we are back at the farm investigating the cause, so that investigation goes on. But, as you know, there can be multiple vectors, avenues for getting this kind of contamination into an open field where product is growing. Mr. Stupak. Right. It was for romaine that was used by the May 12th. Today is May 6th. How long has this investigation been going on? Mr. Taylor. The first cases go back to--the first onset of illness goes back to April 6th. But it has been only in the last week or 10 days that we became aware of this. There is that lag factor between people first becoming ill and it getting reported. Mr. Stupak. Right. Mr. Taylor. And we found yesterday a positive sample of lettuce, which really confirmed the epidemiological hypothesis that this product was responsible for the problem. So there was actually a very swift recall response once the evidence fell into place. Mr. Stupak. And I take it Freshway Foods has been cooperative, no problems there? Mr. Taylor. They have worked closely and responded very quickly when the evidence came into place. Mr. Stupak. OK. Ms. Nudelman, let me ask you this. I am looking at page 10 of your report. That is where you start with Table 1, food facilities inspected by the FDA, fiscal year 2004 through 2008. And I think you testified the average of the inspections were about 24 percent of all the places inspected. Correct? Ms. Nudelman. Yes. Mr. Stupak. Now, the one that struck me was, in 2004 you had 59,305 facilities should be inspected; by 2008, it has grown to 67,819. If my math is correct, that is about 8,514 new facilities in less than 5 years. How is the FDA going to keep up with more and more facilities without the resources? Ms. Nudelman. I think that is a good question. I mean, clearly we document the number of facilities has grown and, at the same time, the number of inspections has declined. I think the other important factor in this is the number of high-risk inspections that are completed. And that is one way to target resources and target---- Mr. Stupak. Right. Well, if we jump to the next table, that is Table 2, which is the high-risk facilities inspected by the FDA and, again, through the same years, 2004 to 2008. You have had, again, more high-risk facilities come online, about 565, if my math is correct here. The number of inspections has actually dropped from 77 percent to 63 percent. Any correlation during that period of time from 2004 to 2008, how many inspectors did the FDA have? Did the number of inspectors go down? Ms. Nudelman. That is correct. And this is one of the things that FDA talked about in terms of the reason why there was a decline in the number of high-risk inspections as well as the number of overall inspections. Mr. Stupak. Let me go to your next chart on page 12, again, number of inspections per facility between 2004 and 2008. I take it facilities inspected more than three times, there is 21 percent of them, were probably the greater or high-risk foods. Ms. Nudelman. I am not positive about that. That makes sense to me, but I am not--I can look at that in a little bit more detail for you. Mr. Stupak. All right. Let me go to the bottom of page 14. In your report, you were talking about the FDA OAI classifications--refused to grant FDA officials access to their records. Most of the facilities had a history of violations. Then you say the FDA does not have statutory authority to require food facilities to provide access to these records. Do you know if the FDA ever received those records in these four or five cases? Ms. Nudelman. In the reports that we looked at, that was for 2008, and it just documented clearly the types of records that they did not receive. I don't know. And maybe FDA has a better sense of that. Mr. Stupak. Yes, I was going to ask Mr. Taylor. Any comment on that? Do you know if they ever received those records? Mr. Taylor. We got what we felt was a satisfactory resolution. Dr. Solomon can walk you through the details of each one. It varied from case to case. But, in some cases, we went ahead and got injunctions to solve the problem or took other forms of enforcement action. And if you would like, we can put---- Mr. Stupak. Sure. Just quickly, if you could just tell us what would happen on those. Mr. Solomon. In one of those cases, we actually used the authority under the Bioterrorism Act, 414, to meet that threshold to have to request those records. Obviously, that delayed us. In two of the other cases, we conducted an injunction in order to try and get those records and requesting others for-- -- Mr. Stupak. Injunction would stop them from doing what, shipping their product? Mr. Solomon. We were able to stop them from shipping product, and, at the same time, we used that consent decree that was signed to go to the suppliers there and get the information that we needed to control the product. Mr. Stupak. OK. So you went to the supplier to find out what the facility was doing? Mr. Solomon. Correct. Mr. Stupak. OK. Mr. Solomon. So these were longer processes that took us to try and get the records that were needed. Mr. Stupak. Sure. OK. My time is up. Mr. Burgess for questions? Mr. Burgess. Just staying with that concept for a minute, Mr. Taylor and Mr. Solomon, on the food safety bill that we passed out of this committee that is now awaiting activity over in the Senate, there is a provision for emergency recall, which I think you referenced, Mr. Solomon, as part of the bioterrorism defense. But, still, it is a voluntary recall under the bill that we passed. Is that your understanding, as well? Mr. Solomon. We don't currently have mandatory recall authority, which is part of the Food Safety Enhancement Act. Mr. Burgess. And after the passage of this legislation, is that a deficiency that you feel will be corrected? Or will you still be relying on the emergency provisions of the Bioterrorism Act to have that emergency provision? Mr. Solomon. We could use all the tools available, and we would use that mandatory recall authority if that was necessary in order to effectuate getting product removed from the market. Mr. Taylor. If I may add, the bill, 2749, would also give us routine records access, so the company would be obligated to provide the records we need to conduct an investigation and to find and discover the problems and solve the problems. Mr. Burgess. Mr. Taylor, congratulations on your new post-- -- Mr. Taylor. Thank you, sir. Mr. Burgess [continuing]. I think, I hope, for you. How many people currently work in your office? Mr. Taylor. Well, in my immediate Office of Foods, it is a very small staff of about 15 people. But we really work within the overall foods program. There is the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and then the large field force. So, you know, there are upwards of 5,000 people in the foods program. But this new office that the commissioner created is a small leadership office, essentially. Mr. Burgess. OK. Do you plan on expanding it? Mr. Taylor. The immediate office will grow slightly, but the last thing we want to do is to try to manage the program from the Office of Foods. We have great management teams and people throughout the foods program and these organizations, and our job is to lead and to unify and elevate their work within the FDA. Mr. Burgess. So, you just referenced the Center for Veterinary Medicine. Those directors report to you, as well? Mr. Taylor. Yes, sir. The director of the Center for Veterinary Medicine reports to me, as does the director of the Center for Food Safety and Applied Nutrition. Mr. Burgess. At this point, are you considering merging the Center for Food Safety as well as the Center for Veterinary Medicine? Mr. Taylor. We have no plans to merge the organizations. We are looking at how we manage this program in a unified way and how we can be sure that we are really able to empower the people in these organizations to accomplish the things they are setting out to accomplish. And so we are looking at how we manage the program, but we have no plan for mergers at this point. Mr. Burgess. Let me just ask you a couple of questions about PREDICT since that has come up in your testimony as well as the testimony of the GAO. It holds promise, correct? Mr. Taylor. Yes, sir. Mr. Burgess. But there were problems. Mr. Taylor. Yes. Mr. Burgess. And those problems were related to the status of the IT systems that are surrounding it? Mr. Taylor. Yes, sir. Really--and I am not the IT expert on the case, but it is really a function of the aging IT infrastructure, the servers, the basic equipment that supports the IT system. And so what happened, in lay terms, is a combination of things. You put this whole new application onto the system, which put extra demand on the system. And it was happening at about the time that we have grown our field workforce. We have been able, with resources Congress has provided over the last couple of years, to hire additional inspectors and other people in our field force. So that combination of extra demands on an aging IT infrastructure resulted in slowdowns and some, you know, servers going down. And the IT people realized that that aging infrastructure could not support the new system. But, again, with resources Congress has provided, we are making the investments to upgrade that infrastructure. So, you know, that upgrade and the imperative to test that carefully and be sure that when we do implement--you know, that is pushing back implementation. But we hope to roll out PREDICT nationwide by the end of the year. That is our goal. Mr. Burgess. You anticipated my question. But I was going to ask you, you have developed a strategic plan for dealing with the deficiencies in the IT architecture? Mr. Taylor. Yes, sir. We have the--you know, upgrades are being made; it is being tested. You know, we will test the PREDICT system before we make it operational. But the IT folks are confident that we will have the infrastructure to support this and, you know, make it serve the function that we know it can, which will really be much better targeting of imports. Mr. Burgess. So when we have this hearing a year from now, you will be able to report to me---- Mr. Taylor. I will be here, yes---- Mr. Burgess [continuing]. Satisfactorily that it has been up and running for 6 months and it is targeted and in the right place? Mr. Taylor. That is our absolute aspiration and goal. We are working hard to achieve it. And we welcome coming back and giving that answer. Mr. Burgess. You can understand the frustration of people who--you know, we are requiring every physician's office across the country to make great investments in information technology, and our own FDA, which is our premiere Federal agency that handles 25 cents out of every Federal dollar, at least domestically, has been unable to meet its own challenge. Clearly, we have to get our own house in order before we can be too critical of other people who have been slow in that regard, as well. Mr. Taylor. I understand. Mr. Burgess. I am going to yield back to the chairwoman. Mrs. Christensen [presiding]. Thank you, Mr. Burgess. The chair is now really honored to recognize our chairman emeritus, Mr. Dingell, for questions. Mr. Dingell. Thank you, Madam Chairman. I commend you for the way you are presiding, and I thank you for being recognized. I want to begin by commending Chairman Stupak and the committee for this hearing. And I want to observe that this committee has completed a rather remarkable piece of legislation with regard to food safety that rests comfortably in the arms of the United States Senate. As my old daddy used to say, that is the place where good legislation goes to die. Regrettably, the points made by the witness on behalf of the GAO are very much on point. Her observation of the two statutory methods that need to be added to the arsenal of FDA are included in that legislation. I know this is going to sound a little hostile to the panel, but I want to begin by commending--and I want you to understand, there is nothing hostile in these questions. But I want to lay the framework of understanding how the events about which we are surrounded affect what it is we are doing. And I will start by observing that FDA, in 2008, inspected 153 foreign food facilities out of 189,000 such facilities registered with FDA. That is, of course, only a small fraction of the, in fact, number of worldwide sources of foods imported to the United States. But we were able, in each of those years, according to GAO, to investigate only a very small number of the massive numbers of exporters into the United States. I noted, with regard to China, FDA conducted 46 inspections to China. China is one of the biggest exporters of food to the United States. I observe that that is a country which sends us melamine in milk products, mushrooms, vegetables, fish, shellfish, and other food products that are contaminated, dirty, filthy, or adulterated. And, frankly, again, the legislation to which we address ourselves sits over there in the Senate. That is a remarkable piece of legislation which came out of this committee unanimously with the full support of every single Member. And the leadership of this subcommittee made it possible for that legislation to move because of the way Mr. Stupak and the members of the committee, including my colleagues on the minority side, worked very hard to see to it that this legislation had not only a proper flooring and support but also a full justification. Now, having said these things, I would like to make a quick observation and then a question. Since 2007, FDA has had two major outbreaks linked to peanut butter, involving hundreds of illnesses and nine deaths. That is out of about the 5,000 deaths that exist in this country. And now I would like to address the types of enforcement action that have been taken against the companies. I would note that the GAO asserts that additional authority to routinely inspect records, detain food, subject violators to civil penalties, subpoena witnesses to help stepped-up enforcement efforts would be significantly helpful. Am I correct in that, to my witnesses down there, particularly you, Commissioner, and you, ma'am, from the GAO? Mr. Taylor. Yes, sir. Those new authorities are crucial to our doing our job. Mr. Dingell. Now, I note FDA's budget anticipates hiring 129 new food and safety inspectors based on revenue from the registration and reinspection fees in H.R. 2749. What will happen, if you please, to its plans to hire these 129 new inspectors if these fees are not included in the bill that the President signs as they are in the budget? Mr. Taylor. We won't be able to hire those inspectors. And, you know, we need more inspections to ensure the safety of food. Mr. Dingell. That means that the ongoing record of dismal ability to investigate or to inspect food processors will continue unabated. Mr. Taylor. Yes, sir. Mr. Dingell. Now, I note that the Peanut Corporation of America recall, while it was still ongoing, one of the companies that received the PCA product, Westco Fruit and Nut Company, refused FDA access to important safety records and refused to conduct a voluntary recall, and FDA seized the product of the company. Now, I note that we should address--in that instance, Food and Drug would be able, had the legislation been passed, to use the mandatory recall authority to remove products that are already on the market. Is that not so? Mr. Taylor. Yes, sir, that is correct. Mr. Dingell. Now, how would such mandatory recall authority result in a different outcome in the Westco case? Mr. Taylor. Well, we could have directed that firm to recall that product, to stop distribution, withdraw the product from the market. We wouldn't have to have been in a lengthy discussion and then have to go to court and get a judicial intervention. We could have acted swiftly with those---- Mr. Dingell. In other words, all of this sawing of the air would have to go on while people were dying of bad peanut butter. Mr. Taylor. Again, if we are delayed in removing product from the market, people are at risk. Mr. Dingell. Now, following the outbreak in the recall first linked to tomatoes and later to jalapeno and serrano peppers, the inspector general identified weaknesses in the current one-up/one-down traceability system, including bad record-keeping, lack of access to records, and firms that didn't know about the requirements. Has FDA's experience in other outbreaks confirmed flaws in the one-up/one-down traceability? Mr. Taylor. Yes, sir. I mean, that requires a lot of shoe leather by FDA. It is an old-fashioned paper system, essentially, when we have electronic alternatives, systems that the industry itself is developing, that can get us this information much more quickly. Mr. Dingell. Now, how important is trace-back in containing food-borne illness outbreaks? Mr. Taylor. Trace-back is crucial. Once CDC identifies the food vehicle, we then need to be able to go back to the source of production so we can get to the root of the problem and contain it. So it is really crucial to public health, as well as to protecting the industry, to contain a problem so that the industry, its own business, won't be disrupted any more than need be. Mr. Dingell. You can protect honest men and women in the industry from unfair competition by scoundrels and rascals, but you would also protect them against unsafe materials that could enter into the products that they distribute. Isn't that right? Mr. Taylor. Yes, sir. That is exactly it. Mr. Dingell. Now, in your report--this is to Ms. Shames. In your report, you state CBP's computer system does not notify FDA when imported food shipments arrive at U.S. ports. It is extremely important that these two agencies coordinate when it comes to imported food. Do you agree with that? Ms. Shames. We agree. We have been able to update that information, and CBP has told us that now it does give FDA the time of arrival. And this should help FDA in terms of coordinating its inspections. Mr. Dingell. What additional steps need to be taken by the administration to fully address this concern? Ms. Shames. We feel that CBP should continue to work towards this effort to share time-of-arrival information with USDA. That part of our recommendation has not yet been implemented. Mr. Dingell. Thank you. Madam Chairman, you have been most kind to me with regard to the time. I yield back the balance. Mrs. Christensen. Thank you, Mr. Chairman. I now recognize myself for 5 minutes of questions. And I want to ask a question about information sharing, as well. Ms. Shames, I would like to ask you about GAO's finding that FDA does not always share product distribution information with State regulators during a recall. If food needs to be removed, FDA may not give State regulators important information like which grocery stores and warehouses received the recalled product. FDA's inadequate coordination with States means that States must duplicate FDA's efforts and track down the same information. You found that public health--and I guess this is a quote--may be at risk during the time it takes for the States to independently track distribution information when a product is found to be contaminated. So my question, Ms. Shames: FDA's limited provision of information to States during an outbreak seems illogical, so what is the agency's rationale for withholding that information? Ms. Shames. FDA says that this information is commercially confidential. And while we recognize that, we still recognize the public need that the State agencies are often the ones that are actually going into the grocery stores and removing the contaminated product off of the shelf. What we recommended to FDA and what FDA agreed to is that they would explore ways to try to get comparable information to the State agencies. I should note that USDA, the Food Safety and Inspection Service, does give product name information to the States as a way of trying to expedite any recall. Mrs. Christensen. OK. So, Mr. Taylor, so you have agreed, and you have the authority to share that information with the States? Mr. Taylor. We are able to share this information with State officers who are commissioned by FDA. And to some extent around the country we have actually commissioned State officials to function as FDA officials, so we are able to do it to that extent. But we do have legal constraints under the laws that govern disclosure of information. This is a strong feature of the legislation, H.R. 2749, that this committee has passed, that the House has passed, because it would explicitly authorize us to share information with State officials, with other organizations, when necessary to protect public health, and still protecting the confidences of companies but getting the information in the hands of people who need it to protect public health. And we enthusiastically embrace that. We need that clear authority from Congress. Mrs. Christensen. OK. Thank you. You answered the rest of my question. My next question is on monetary bonds and civil penalties. I am concerned that FDA may not have sufficient authority to keep an importer from violating food safety requirements. Under our current system, the importing company maintains control over their food shipments but is not allowed to release them until FDA approves. Importers post a monetary bond with Customs and Border Protection to guarantee the product will meet all U.S. Requirements, including those of FDA. At least, that is how the system is supposed to work. But the GAO investigation found that FDA and Customs and Border Protection officials do not believe that the bonding system stops import firms from releasing their goods prior to FDA approval. GAO found that many brokers and importers expect that they will occasionally have to forfeit the monetary bond as part of the cost of doing business. So, again, my question to you, Ms. Shames, is: Why is the current system of monetary bonds not a sufficient deterrent? Ms. Shames. What we are seeking is for FDA to be able to assess the civil penalties, to make it more of a deterrent for unscrupulous importers who try to do that. Mrs. Christensen. Is the amount of the bond adequate as a deterrent, or does it need to---- Ms. Shames. FDA and CBP officials told us that they thought that the amount of the bond really was insufficient. And this is something that we reported in an earlier report back in 1998. So, well over a decade ago, we were hearing this information from those agencies. Mrs. Christensen. And your testimony stated that GAO recommends that the FDA commissioner seek authority from Congress to assess civil penalties. Can you elaborate? Why does FDA need authority to assess the civil penalties? Ms. Shames. Now it cannot do that; it relies on CBP for any enforcement actions. And giving FDA this authority, again, we feel, would be a deterrent for any unscrupulous importers. Mrs. Christensen. So, Mr. Taylor, if FDA could impose civil monetary penalties for violations of food safety requirements, would that assist FDA in its mission? Mr. Taylor. That would be a big help, to create more accountability for importers. There is another very important feature of the legislation, though, that would require importers to register with us and to meet requirements for their own practices in order to stay registered, to stay in business as importers. So we would have also the authority to de-register an importer. So, again, it is critical that we enhance the accountability of importers to play by the rules, essentially. Mrs. Christensen. Is there authority needed to increase the amount of the bond--well, that would be CBP. Mr. Taylor. Right. Mrs. Christensen. Yes. Thank you. OK, I am out of time. So are we going to have a second--oh, you are back. I will recognize Mr. Burgess, Dr. Burgess, for a second round of questioning. Mr. Burgess. Thank you. Mr. Taylor, approximately 13 million shipments of food arrive in the U.S. Every year from foreign producers. And, of course, the number is growing, as we have seen from all the graphs. There are numerous examples of foods that have been problematic. We have heard about the melamine in the milk and the problems with gluten and some of our pet food contamination of a few years ago. You have opened some stations overseas, the FDA has opened some stations overseas. In addition to that--and the first question is, have we opened enough? Have we done enough in that regard? And what other measures are we employing to increase or enforce lax safety standards in other countries? Mr. Taylor. Yes. You know, I think it is going to take a combination of tools and efforts to ensure the safety of imports. Those foreign offices are--they are not inspection posts, but they are critical posts for gathering intelligence about what is happening in other countries, to explain our requirements to foreign governments and to foreign firms. But that is just one small piece of the toolkit. We do need to do more inspections overseas, but we also need to hold the importer accountable and see that they are policing their own supply chain and being able to provide real assurances to us, documented assurances, that they are producing products overseas or sourcing their product from facilities that meet our standards. So it is going to take a combination of things. But it is all about building more accountability into the supply chain, all the way back to the point of production. Mr. Burgess. And it would seem intuitive that the importer would want that accountability in the supply chain, because, after all, if their products are felt to be unsafe when they get over here, their market share is going to suffer. But is the FDA working with the importers directly in a collaborative fashion, educational fashion, to try to get more accountability on that end? Mr. Taylor. We do work with the importer community. We have issued guidance to the importer community on good importer practices that we think they should observe to meet that responsibility, to offer food only that meets our standards. You know, some importers feel the accountability. They are part of a supply chain. The major processor in this country might be the importer, in some cases. But, in other cases, importers don't have a stake in what happens to the food after it passes from them, and so they lack accountability. And so there is a real gap in the system, you know, if we don't have systematic accountability on importers as a critical part of the safety assurance system. Mr. Burgess. So what can you do to impose that degree of accountability if it may not exist naturally as part of the marketplace? Mr. Taylor. We need the passage of H.R. 2749. That is one of the most critical elements of the legislation, to define that accountability, to give us the authority to set the rules that the importers need to play by in order to provide an adequate assurance that the food that they are offering is meeting our standards; again, backed up by our own ability to go inspect, backed up by what foreign governments are doing, backed up by a host of other checks. But that importer accountability is really a linchpin of the system. And it is lacking now as a really enforceable matter. It is something we urge on the industry, but there is no legal requirement for the importer to really take that responsibility. They only run the risk that we will send the food back. Or, you know, they may get it into the country under a bond, and, as a cost of doing business, you know, some of them, unscrupulous, will make a decision to let the product go. So there is a lack of accountability in that part of the system that H.R. 2749 would directly address. Mr. Burgess. I have always felt that it really is necessary to have some sort of a stop button that you guys can push in a hurry if you need to, if we find that we have something coming in that we really shouldn't. Ms. Nudelman, let me just ask you a question. And I apologize if Chairman Stupak has already covered this. But, in the report, it found in fiscal year 2007 the FDA took no regulatory action for 25 percent of facilities who received the OAI classification. Why would the FDA classify a facility as ``official action indicated'' rather than one of the lesser classifications and then take no action? What would be a possible--that seems counterintuitive to me. What would be a possible rationale for doing that? Ms. Nudelman. Well, in some cases, if the facility agreed to take action or promised to take action, then they did not issue--they did not take any further regulatory action. That was the most common response that we heard. Mr. Burgess. And then how is the follow-up for that overseen to ensure that, indeed, the voluntary action was taken and the problem was corrected? Ms. Nudelman. Well, that is one of the things we found. In about 36 percent of the facilities, FDA didn't take any--didn't reinspect to ensure that the correction was made or look at any other evidence. So there is not always the follow-up. Mr. Burgess. So that is still inherently a weak spot that needs to be fixed. Ms. Nudelman. Correct. Mr. Burgess. Thank you, Mr. Chairman. I will yield back. Mr. Stupak [presiding]. Mr. Dingell, did you have a question or two on this second round here, please? Mr. Dingell. Mr. Chairman, I will impose again briefly upon your patience. And I want to thank for your courtesy to me. And I also want to commend you for the series of hearings you have held on these matters, because they have made it possible for us to move forward in a very significant fashion to protect people and to see that Food and Drug finally has the law and the resources it needs to do its business. Now, these questions are for Ms. Nudelman. There are 226,373 foreign food facilities registered with FDA. When the inspector general looked at the domestic facilities registered in 2009, it found 48 percent provide inaccurate information; 7 percent either fail to register or failed to cancel their registrations; and 5 percent created multiple registrations. Now, if domestic registrations are this prone to errors, in your opinion, how reliable is the list of foreign facility registrations? Ms. Nudelman. The numbers that you cite are right on, and it would make--I think it is even more challenging for foreign facilities to have accurate information in the registry. Mr. Dingell. Now, what can be done to help FDA improve the accuracy of its registration lists? Obviously, more people; obviously, more money; obviously, more inspections; obviously, a better computer system. Do they need, in addition to that, additional authority under law to do the things that need to be done, to induce better cooperation from the people who are supposed to register? What has to be done, in your expert opinion? Ms. Nudelman. I think there is a number of ways FDA can improve the accuracy and the completeness of the information in the registry. We make a recommendation to FDA to consider seeking the authority to have facilities register on a more routine basis. And that would allow the facilities to provide updated information about the foods they handle and about contact information. Mr. Dingell. Thank you. Now, Mr. Taylor, do you have a comment you would like to make? Mr. Taylor. Well, I think that suggestion that Ms. Nudelman made is an excellent one. I think the requirement to have a unique identifier is important. And I think the requirement for the importer, as part of good importer practices, to be able to vouch for the accuracy of the information, identifying the foreign sources of supply, the foreign facilities from which they are sourcing products for import--all of those, I think, would really improve the reliability of the registration list. And those are all addressed in the Food Safety Enhancement Act. Mr. Dingell. Now, Ms. Shames, you have talked about the ability to inspect. And, in your very excellent study, you talked about the need for FDA to be able to do a better job of getting the cooperation of Homeland Security and other government agencies. How could that best be done? Could that best be done by having a memorandum of agreement between the agencies, a memorandum of agreement required by congressional action, or by some other mechanism whereby we could see to it that these two very important agencies, or several very important agencies, talk to each other so that they are able to use the advantages that comes with having several different agencies enforcing different laws but able to work together to address the problems that concern us? Now, what is your comment, please? Ms. Shames. It will be a multifaceted solution to a very complicated problem, and I wish I could tell you that there will be a single step that could correct that. We found that at the working level that the relationships between FDA and CBP were oftentimes very cordial, that they were able to work around, for example, not getting the time of arrival information. Mr. Dingell. Of course, that is a structural failure, is it not? Ms. Shames. Well, yes, in this case it was. Mr. Dingell. And whose fault is that, the other agency or is that the importer or the food broker or who? Ms. Shames. Well, there are many players that are involved in the oversight of food safety. FDA is one, and, as you noted, CBP really is the first face for an importer. So one of the challenges that we identified is CBP's own computer system, that that system---- Mr. Dingell. And that's probably hopelessly out of date, as is the Social Security computer system. Ms. Shames. Well, there are hardware changes that would have to be made, for example, for getting a unique identifier. This is something that FDA feels it needs. We have certainly identified that it's something that is very important, but CBP told us that it would be difficult for its current system to do it, and they really could not offer any sort of timeline of when that might be done. So it's structural in terms of the many agencies that are involved, but it also gets to the resources in terms of, you know, the computer systems that it has in place as well as the people. Mr. Dingell. Thank you. Mr. Chairman, again, thank you for your courtesy to me, and I want to remind everybody that you and this subcommittee have had tremendous leadership in this matter. I want to remind everybody that this committee, working unanimously, together in a bipartisan fashion, has set out legislation that would address the problems we now discuss today, which reside comfortably in the United States Senate. Thank you, Mr. Chairman. Mr. Stupak. Well, hopefully the Senate will move that legislation, get it to conference, and we can go from there. Let me ask, Ms. Shames, about the unique identifier. How can one firm have 75 different identifiers? Ms. Shames. It can happen very inadvertently, when a company registers for an import shipment, it may identify itself one time as White, Incorporated. The second time the company might identify itself as White Company. So it is something that is done most of the time, very innocently, but it means that there needs to be some sort of scrubbing of the list to make sure that each company has a single---- Mr. Stupak. So the company enters its information on a computer Web site so it is really the company that enters it, which would then give it a number---- Ms. Shames. That's right. Mr. Stupak [continuing]. Which could be unique on something as simple as an address, a different address. Ms. Shames. Yes. Mr. Stupak. Does Customs and Border Patrol use unique identifiers? Ms. Shames. They do not, no. They also---- Mr. Stupak. Shouldn't they actually have access to it at the same time? Shouldn't that company give it to Customs and Border? Ms. Shames. Ideally FDA and CBP and would have the same unique identifier. Mr. Stupak. Ideally, but reality is they don't, right? Ms. Shames. Right. Mr. Stupak. If we would limit the number of ports that food could be imported into this country, would that help? Ms. Shames. Well, that is an approach that USDA takes. Mr. Stupak. Right, on meat products. Ms. Shames. Well, that only USDA regulated imports come from food systems that have or are equivalent to ours, only through designated ports. USDA also goes and audits those countries to make sure that their systems are comparable or equivalent. Mr. Stupak. Well, is that something we should look at? I was going back to your chart number one that you had in here, you know, you said 80 percent of our seafood comes from foreign sources, I think she said 60 percent of our fruits and vegetables. And they can come into basically any airport or any trucking location on our border,correct? Ms. Shames. That's true, yes. Stakeholders that we have spoken to said that it would be difficult for FDA to really replicate the same system that USDA has, because---- Mr. Stupak. I am not saying replicate it, but shouldn't you limit the ports of entry? I mean, how can you control anything if every airport and every truck crossing is basically a port of entry for food or seafood? Ms. Shames. Well, it's an approach that the European Union has taken to limit the ports for its risk-based foods, so it is--there are precedents for it. Mr. Stupak. Any comments on that, Mr. Taylor, on either unique identifiers or limit the number of ports? Mr. Taylor. Yes. Again, from a consistent--an ease of implementation by the regulatory agency, that's certainly advantages to that. I think the challenge we face that is different from the USDA is that, you know, we are dealing with a much larger array of commodities coming from a much larger volume of countries, there's a huge volume of trade. And so I think there would be, you know, big practical questions you would have to work through. I don't think anyone wants to disrupt the trade in food, but we need to be sure it's safe. And how do you do that? It's a really important question. Mr. Stupak. Let me ask you this then, Mr. Taylor, you mentioned the shipper's bond. What is the usual amount of a bond? Does it depend on the product and the value? Mr. Taylor. Typically three times the value of the shipment. Mr. Stupak. OK. You said many times the shipper will just forego the bond. Mr. Taylor. Again, our understanding is that some shippers, you know, who have a large volume of business are willing to just take that chance of letting a product go out into commerce, even though it's still under bond, because, you know, in the whole course of their business they don't get caught very often or they aren't--there's not a problem that requires that that product be brought back. And so, again, it's the cost of doing business for some of these firms. Mr. Stupak. Well, should we make it higher? Mr. Taylor. I think you could try a higher bond. I mean, I think the civil penalty approach is one part of it. I think the importer accountability and the fact that an importer could lose its registration under the Food Safety Enhancement Act would be perhaps even stronger tools, you know, to make them have really something really at stake for playing by the rules. That's what we need to do. Mr. Stupak. You know, Mr. Dingell pointed out, and I think we have all pointed out that, you know, it's expensive to keep our food supply safe and the agency needs inspectors, and I think GAO report says, what, $16,000 per inspection at a food facility. And the IG said that, and I am quoting now, The decline in inspection is largely due to the significant decline in staffing level that resulted from cuts. And in the legislation that we have pending in the Senate, the Food Safety Enhancement Act, we have an annual registration fee of $500. These fees would be devoted towards funding a variety of food safety activities. Any idea and what percentage would go towards inspectors? Mr. Taylor. Well, we would envision the fee revenue being used to a significant degree to meet the inspection mandates, or to at least contribute to meeting the inspection mandates in the legislation. But we also have to invest those resources in the tools for the inspectors and the scientific basis for what they are doing, so it would be a mix of activities. And you could also contribute to the import oversight. So we would distribute it across a mix of activities to meet the objectives of the statute. Mr. Stupak. Well, under the Obama administration, did you not receive a substantial increase in money for food safety in the last year? Mr. Taylor. The 2010 budget is, yes, is an increase over 2009, and there's an increase requested in 2011. Mr. Stupak. Well, have you hired more inspectors? Mr. Taylor. Yes, sir, the last 2 or 3 years of funding has enabled our field force to add 6- or 700 inspectors, who are completing their training, and we are going to be able to increase our inspections because of that in the coming years. So there has been that step up, you know, through the increases we have gotten. It's not sufficient to meet the inspection mandate in the legislation, but it's a step in the right direction, which we appreciate. Mr. Stupak. OK. Mr. Burgess, any questions? Mr. Burgess. Yes. Just following up on that last line from Mr. Stupak about the budget, did you, did the FDA receive any money from the stimulus bill or the big health care bill that we just passed? Mr. Taylor. No--there was some money that went into HHS for management matters related to FDA like comparative effectiveness of pharmaceuticals, but there was not money that directly affects the food program. Mr. Burgess. Did the Obama administration seek funding for the FDA in either one of these laws? Mr. Taylor. Well, again, the stimulus money was about immediate projects that could stimulate economic activity in the near term and so that we---- Mr. Burgess. Mr. Taylor, we gave $10 billion to NIH. Are you any less deserving than they are? Mr. Taylor. We would never say---- Mr. Burgess. $10 billion to NIH. Now I love the guys at NIH, but you are important too. Mr. Taylor. Yes, sir, we agree with you. Mr. Burgess. Well, do you know why the administration didn't ask for additional funding for the FDA in either of these laws? Mr. Taylor. I would have to get back to you on that. I don't personally--I wasn't involved in that. Mr. Burgess. Well, and it's all well and good, just like the Obama budget, and what great things are going to happen as a result of it, but we are not going to pass a budget on the floor of this House I don't think, unless Mr. Stupak knows something that I don't know---- Mr. Stupak. It wouldn't be first time getting me wrong on legislation. Mr. Burgess. And certainly, we are not going to do any appropriations bills before election day, so your level of funding till some omnibus in the lame duck session, so are you oK with that level of funding at this point? Mr. Taylor. Well, again, we are going to need additional resources to carry out the expectations of the Food Safety Enhancement Act. Again, that's why the fee provision and that-- the registration fee provision in that law, that bill is very important to us. We do need a stable, predictable and adequate level of resources to meet the mandates in the legislation. Mr. Burgess. Well, and I couldn't agree with you more and that a stable, predictable source of funds is not just true for you but true other agencies as well, but so far we seem to be doing things in fits and starts. And you, in fact, got left out of the fits and starts, unfortunately. Mr. Chairman, you have been very indulgent. It has been a long day. I am going to yield back the balance of my time. Mr. Stupak. Thanks, Mr. Burgess. And as Mr. Dingell has pointed out, you know, the Food Safety Act went through this committee 51-0, and we appreciate our colleagues on the Republican side of the aisle to help us provide a stable funding source for that FDA through that $500 per facility registration fee. That will provide the stable funding so we do have the resources to get to it. It's not just resources it's, information sharing. And hopefully we can do that whether it's Customs and Border Patrol or we get the PREDICT program worked out a little more so the high risk foods we can identify. Well, thank you and thank you to all of our witnesses. Sorry about the delay there on the floor for a while. We appreciate you staying with us and being here today. That concludes all questioning. I want to thank all of our witnesses for coming today and thank you for your testimony. The rules of the committee provide that members have 10 days to submit additional questions for the record. That concludes our hearing. This meeting of the subcommittee is adjourned. [Whereupon, at 4:58 p.m., the subcommittee was adjourned.] [Material submitted for inclusion in the record follows:] [GRAPHIC] [TIFF OMITTED] T6573A.056 [GRAPHIC] [TIFF OMITTED] T6573A.057 [GRAPHIC] [TIFF OMITTED] T6573A.058 [GRAPHIC] [TIFF OMITTED] T6573A.059 [GRAPHIC] [TIFF OMITTED] T6573A.060 [GRAPHIC] [TIFF OMITTED] T6573A.061 [GRAPHIC] [TIFF OMITTED] T6573A.062 [GRAPHIC] [TIFF OMITTED] T6573A.063 [GRAPHIC] [TIFF OMITTED] T6573A.064 [GRAPHIC] [TIFF OMITTED] T6573A.065