<DOC> [110th Congress House Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:45731b.wais] DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE NATION'S FOOD SUPPLY? ======================================================================= HEARINGS BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS FIRST SESSION ---------- OCTOBER 11, NOVEMBER 13, 2007 ---------- Serial No. 110-33 Pt. B Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE NATION'S FOOD SUPPLY? ======================================================================= HEARINGS BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS FIRST SESSION __________ OCTOBER 11, NOVEMBER 13, 2007 __________ Serial No. 110-33 Pt. B Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov ----- U.S. GOVERNMENT PRINTING OFFICE 45-731 PDF WASHINGTON : 2008 ---------------------------------------------------------------------- For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free(866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC 20402-0001 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 J. DENNIS HASTERT, Illinois FRANK PALLONE, Jr., New Jersey FRED UPTON, Michigan BART GORDON, Tennessee CLIFF STEARNS, Florida BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia ANNA G. ESHOO, California ED WHITFIELD, Kentucky BART STUPAK, Michigan BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico GENE GREEN, Texas JOHN B. SHADEGG, Arizona DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING, Vice Chairman Mississippi LOIS CAPPS, California VITO FOSSELLA, New York MICHAEL F. DOYLE, Pennsylvania STEVE BUYER, Indiana JANE HARMAN, California GEORGE RADANOVICH, California TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania JAN SCHAKOWSKY, Illinois MARY BONO, California HILDA L. SOLIS, California GREG WALDEN, Oregon CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska JAY INSLEE, Washington MIKE FERGUSON, New Jersey TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan MIKE ROSS, Arkansas SUE WILKINS MYRICK, North Carolina DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania JIM MATHESON, Utah MICHAEL C. BURGESS, Texas G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee CHARLIE MELANCON, Louisiana JOHN BARROW, Georgia BARON P. HILL, Indiana ______ Professional Staff Dennis B. Fitzgibbons, Chief of Staff Gregg A. Rothschild, Chief Counsel Sharon E. Davis, Chief Clerk Bud Albright, Minority Staff Director ______ Subcommittee on Oversight and Investigations BART STUPAK, Michigan, Chairman DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky CHARLIE MELANCON, Louisiana Ranking Member HENRY A. WAXMAN, California GREG WALDEN, Oregon GENE GREEN, Texas MIKE FERGUSON, New Jersey MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania JAN SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas JAY INSLEE, Washington MARSHA BLACKBURN, Tennessee JOHN D. DINGELL, Michigan (ex JOE BARTON, Texas (ex officio) officio) (ii) C O N T E N T S ---------- OCTOBER 11, 2007 Hon. Bart Stupak, a Representative in Congress from the State of Michigan, opening statement.................................... 1 Hon. Ed Whitfield, a Representative in Congress from the Commonwealth of Kentucky, opening statement.................... 3 Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement................................. 5 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement.............................. 6 Hon. Jay Inslee, a Representative in Congress from the State of Washington, opening statement.................................. 8 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement............................... 9 Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement................................. 10 Hon. Gene Green, a Representative in Congress from the State of Texas, opening statement....................................... 11 Hon. Charlie Melancon, a Representative in Congress from the State of Louisiana, prepared statement......................... 12 Witnesses David Nelson, Senior Investigator, Committee on Energy and Commerce, U.S. House of Representatives........................ 13 Prepared statement........................................... 16 Michael F. Martin, Analyst, Asian Trade and Finance Foreign Affairs, Defense, and Trade Division, Congressional Research Service, Library of Congress................................... 38 Prepared statement........................................... 41 James M. Rice, vice president and country manager, Tyson Foods, Incorporated................................................... 66 Prepared statement........................................... 67 David W.K. Acheson, M.D., Assistant Commissioner, Food Protection, Food and Drug Administration, U.S. Department of Health and Human Services...................................... 81 Prepared statement........................................... 84 Answers to submitted questions............................... 124 Margaret O'K. Glavin, Associate Commissioner, Food and Drug Administration, U.S. Department of Health and Human Services... 97 Richard Raymond, M.D., Under Secretary, Food Safety, Food Safety and Inspection Service, U.S. Department of Agriculture......... 100 Prepared statement........................................... 102 Submitted Material Subcommittee exhibit binder\1\................................... 136 NOVEMBER 13, 2007 Hon. Bart Stupak, a Representative in Congress from the State of Michigan, opening statement.................................... 295 Hon. Ed Whitfield, a Representative in Congress from the Commonwealth of Kentucky, opening statement.................... 297 Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement................................. 298 Hon. Marsha Blackburn, a Representative in Congress from the State of Tennessee, opening statement.......................... 300 Hon. Jan Schakowsky, a Representative in Congress from the State of Illinois, opening statement................................. 301 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement.............................. 302 Witnesses Daniel Engeljohn, Deputy Assistant Administrator, Office of Policy, Program and Employee Development, Food Safety and Inspection Service, U.S. Department of Agriculture............. 305 Prepared statement........................................... 307 Answers to submitted questions............................... 440 David W.K. Acheson, M.D., Assistant Commissioner for Food Protection, Food and Drug Administration, U.S. Department of Health and Human Services...................................... 308 Prepared statement........................................... 311 Mike Picchietti, president, Regal Springs Trading Company; member, American Coalition for Tilapia, Bradenton, FL.......... 361 Prepared statement........................................... 364 Nancy Donley, president, S.T.O.P. (Safe Tables Our Priority), Northbrook, IL................................................. 378 Prepared statement........................................... 380 Wenonah Hauter, executive director, Food & Water Watch, Washington, DC................................................. 387 Prepared statement........................................... 389 Gregory Page, chief executive officer, Cargill, Incorporated..... 403 Prepared statement........................................... 405 Jeffrey M. Ettinger, chairman, president, and chief executive officer, Hormel Foods Corporation.............................. 408 Prepared statement........................................... 410 Doug Brinsmade, president and chief executive officer Anova Food, Incorporated................................................... 416 Prepared statement........................................... 417 Submitted Material Robert Post, Deputy Director, Center for Nutrition Policy and Promotion, U.S. Department of Agriculture, answers to submitted questions...................................................... 443 Laura Tarantino, Director, Office of Food Safety Additive, Center for Food Safety and Applied Nutrition, Food and Drug Administration, U.S. Department of Health and Human Services, answers to submitted questions................................. 450 Submitted Material Subcommittee exhibit binder\2\................................... 452 ---------- \1\ Exhibits that have been omitted are on file in the committee offices. \2\ Ibid. DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE NATION'S FOOD SUPPLY? PART III ---------- THURSDAY, OCTOBER 11, 2007 House of Representatives, Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, Washington, DC. The subcommittee met, pursuant to call, at 9:30 a.m., in room 2123, Rayburn House Office Building, Hon. Bart Stupak (chairman) presiding. Present: Representatives DeGette, Melancon, Waxman, Green, Dingel, Whitfield and Burgess. Staff present: John Sopko, Scott Schoyel, David Nelson, Joanne Royce, Kevin Barstow, Richard Wilfong, Kyle Chapman, Alan Slobodin, Pete Spencer, Garrett Golding, and John Stone. 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 on Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply, Part III. Each Member will be recognized for a 5-minute opening statement. Today we hold the third hearing of the subcommittee dealing with the safety and security of the Nation's food supply. This hearing will focus on the safety of food imported into the United States and the adequacy of the efforts of both the FDA and the USDA to protect Americans from unsafe imported food. We will also examine what food safety and quality control systems other countries use to protect their food imports. Due to the globalization of the American economy, there has been a dramatic increase in the amount of imported food in recent years. In the last decade alone, USDA regulated meat and poultry imports have increased by 87 percent. In the same time, overall imports to the United States have tripled to almost 2 trillion per year. At a time when food imports are sharply increasing, FDA inspectors of imported food have decreased by 90 percent from 50,000 inspections in 1972 to just 5,000 in 2006. The FDA now inspects less than 1 percent of all imports, and only a fraction of that number are even tested. This is simply unacceptable. We need a food safety system capable of combating dangerous food imports. Unfortunately, the Food and Drug Administration's current system is woefully inadequate. Approximately 150 countries import food into the United States. Because of recent high-profile events such as melamine contaminated wheat gluten and seafood laced with unapproved antibiotics, imports from China have received most of the attention. As with other countries, Chinese imports in the United States have steadily increased. However, Chinese imports have increased more rapidly than the global average. Between 1996 and 2006, the last 10 years, the volume of imports of Chinese agricultural and seafood products have increased by 346 percent. China is now the third largest exporter of agricultural and seafood products into the United States. Because of the concerns regarding the safety of Chinese food imports, on August 17, Chairman Dingell and I dispatched committee staff to China to ascertain whether food from that country could be imported safely into the United States and to determine whether China has taken or is taking the necessary steps to assure the safety of its food exports. While in China, committee staff met with government officials from China, Hong Kong and the United States. They met with American and other multinational executives and news reporters that covered food issues for their media outlets. In our first panel today, we will hear directly from the committee staff about their findings. Testifying on the second panel will be Dr. Michael Martin of the Congressional Research Service. Dr. Martin is an expert in Asian trade practices and has familiarity with Japan and Hong Kong's quality control systems for dealing with imported foods. He will testify regarding the methods employed by Japan and Hong Kong to ensure the safety of food imports from China. The committee would like to extend a special thank you to the Congressional Research Service for its valuable work in detailing food import issues. The work of Geoffrey Becker is especially appreciated. Also testifying on the second panel will be Mr. James Rice, vice president and country manager for Tyson Foods in China. He is an executive with over 20 years of experience in China. He will testify about quality control issues in China, including steps that the Japanese take to ensure the safety of imports coming from China and the quality control measures that Tyson employs in China to ensure the safety of the food it produces there. Finally, the third panel will be comprised of officials from both the USDA and FDA. Dr. Richard Raymond of the USDA will testify regarding the policies that his agency pursues to ensure the safety of beef, pork, poultry and egg imports. Dr. David Acheson and Ms. Margaret Glavine of the FDA will testify about the process that the FDA employs to ensure the safety of FDA-regulated food imports. We also expect them to address specific issues of imported food safety. Recently, Chairman Dingell and I introduced a bill that will address many of the FDA's deficiencies. The bill would give the FDA a credible start in obtaining the resources it needs to deal with the flood of imported food. This hearing will also explore whether the FDA has the system or the will to use any new resources wisely. This subcommittee has already uncovered evidence of the FDA's ability to squander resources through giving excessive bonuses to personnel at headquarters, attempting to consolidate decision making at headquarters instead of deploying urgently needed resources in the field and the fraudulent abuse of religious leave. Simply put, the FDA must use its resources more wisely to accomplish its mandate of protecting the Nation's food supply. American consumption of imported food will continue to rise in the future. So now more than ever our country's Federal food safety system needs to be strong enough to protect the public health, our national security and our economy. Today's hearing will discuss what must be done to make this a reality. That's the end of my opening statement. I would now like to recognize the gentleman from Kentucky, the ranking member, Mr. Whitfield, for his opening statement OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY Mr. Whitfield. Chairman Stupak, thank you very much. We look forward to this hearing today as we continue our efforts to answer the question, can the FDA assure the safety and the security of the Nation's food supply? That's a question that most Americans want answered, and they want to feel comfortable with that answer. Every day we read it seems about additional problems with imports of our food supply such as tainted pet food, wheat gluten. Seafood from China, for example, made national headlines earlier this year. Our concerns over weaknesses and FDA's food import system persists. Minority committee staff recently learned that, in February 2006, FDA received information from its pilot program called Predict that a cancer-causing disinfectant, malachite green, was detected in Chinese farm-raised seafood in South Korea and Canada. Canada announced the detentions of all Chinese eel products starting January 31, 2006, but it took FDA over 6 months before it imposed an import alert, and still bad products were shipped into the country. This morning we will hear about China's food safety system as well as neighboring systems in Hong Kong and Japan. And we're hopeful that that information will shed light on measures that may increase our confidence in the safety of our food imports. As we examine these issues today, I think we can agree that FDA, many of us feel, requires fundamental reform of its approach to import safety. We know that the FDA employees are dedicated and committed to accomplishing this task. But all of us are interested in looking at ways that we can improve their efforts. The agency's 100-year-old regulatory approach to food safety cannot deal with the huge growth in food imports over the past decade. This import surge is really astounding. In 1980, there were 1 million food lines of entry into America. And today, there are well over 10 million food lines. Imports have risen 15 percent annually over the last 10 years, and this number is expected to rise. At the same time, while imports represent a larger portion of our food supply, roughly 15 percent overall, some products such as imported fresh fruits account for up to 60 percent of our food supply in that category and even 80 percent for seafood. The percentage of imports inspected by FDA has plummeted from roughly 8 percent in 1992 to my understanding roughly 1 percent today. This is a situation with an agency that has jurisdiction over the 80 percent of our food supply but operates with only about 20 percent of the U.S. food safety budget. And that's because the Department of Agriculture has the largest percent of that budget. But numbers don't fully explain the problem. As we've discussed in past hearings, the FDA's import system is not really set up to deal with the realities of global commerce. We can no longer rely upon border operations as the primary line of defense to ensure imported food safety. Giving more money alone is not the answer. The FDA must deploy a risk-based import inspection system where the agency identifies and prioritizes important risks well before a shipment reaches our shores. To do this, the agency needs to increase its information about foreign food manufacturers, their products, their distribution chains. FDA must profile food control agencies in foreign countries, understand what they do, and where they are developing new programs. It needs better information about particular food facilities and production practices abroad. This requires modern information systems as well as an increased overseas presence for inspections and information-gathering activities. To accomplish this, FDA should have a separate foreign inspections program with inspectors assigned full time. An effective system also requires FDA to implement new information and risk-modelling systems. We understand some of this information technology already exists today, but the agency, for whatever reason, has been slow to deploy it. For example, Predict, an automated import entry system, supports risk assessments and has been operating only at one port and only for seafood for the past 3 years. FDA, we hope, will move quickly to expand use of this system or one similar to it. I would also just point out that the minority committee staff requested recently names and locations of individuals that work at FDA who work full time on import inspections. And FDA provided the information, showing that there were only 30 full-time import entry reviewers. There were zero full-time import inspectors and zero full-time import investigators. Now FDA did provide the name of 213 employees who spend the majority of their time working on import activities. But even using the measuring term that FDA has called full-time equivalents, they said there are 454 investigational operational import full-time equivalents today. And back in 1992, there were 631. And yet we see this dramatic increase in the number of imports. And yet the full-time equivalents working on this area of food inspection safety seems to be decreasing. So, hopefully, this hearing will supply some answers for us. And, Mr. Chairman, we look forward to working with you as we move forward on this important issue. Mr. Stupak. I thank the gentleman for his opening statement. Ms. DeGette for an opening, please. OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO Ms. DeGette. Thank you, Mr. Chairman. The most important thing that this subcommittee can do is continue to be a watchdog for public health and safety. And I appreciate you holding this series of hearings. Until quite recently, it never occurred to ordinary Americans that they needed to be concerned about the safety of the food they purchased from their neighborhood grocery store. But with products affecting ground beef, peanut butter, spinach, toothpaste, cough syrup, lettuce and even pet food in the news almost daily over the last year, people no longer assume, and rightly so, that what they buy is safe. A recent survey showed an all-time low in consumer confidence in their food. And who can blame them? Our food safety system was simply designed for a different era. In 2007, we are at the mercy of a food safety system that was designed for the 1970s. If you look at my chart, today we are importing a dramatically larger percentage of our food than even a decade ago. If you look at this chart, imports just from China have skyrocketed in the past 5 years. In fact, according to the Congressional Research Service, imports of Chinese agricultural and seafood products alone have increased almost 350 percent since 1996 from $880 million to over $4 billion in 2006 alone. And this is just the imports from China. The red line would be even more dramatic if we looked at food imports from other countries as well. At the same time that these imports have increased though, the FDA's food budget has stayed nearly constant but with more demands on that budget. The FDA's food division operated under a shortfall of nearly $140 million in 2006 due to a combination of increased personnel costs and new terrorism responsibilities. So that results in essence in a budget cut of nearly 25 percent. And as Mr. Stupak said, this indefensible resource shortfall has been combined with mismanagement of resources at the FDA. While increasing numbers of imports have provided consumers with lower prices and more choices, I'm going to guarantee you, if you asked my constituents, they never bargained for a corresponding decline in food safety with those lower prices. They want the lower prices, yes, but they also want us to ensure that the food coming into this country is safe for them to consume. The rise in imports is not necessarily problematic in and of itself. But when you couple that with an outdated and underfunded screening system, we've seen the results. And worse is to come if we don't fix the problem. Adding more inspectors and finding a way to pay for them is one step, but there are other steps that we need to take. And some of the members of this committee I'm sure will talk about it today. We need to, first of all, ensure that safety is built into the system so that we eliminate contamination in the first place. And second, we need to build the regulatory framework required to effectively deal with an outbreak should one occur. We all realize this is not just an issue of imported foods. The Topps beef contamination and yesterday's Sam Club's recall are just the most recent examples of problems right here at home. It seems like every time we have a hearing, there's been a recall about a day before. And that just shows the extent of the problem. There's a lot of legislation. Chairman Dingell has introduced a bill. I have a bill, H.R. 3484, the Safer Foods Act, which gives the FDA and USDA mandatory recall authority in the event of an outbreak. And there are other bills as well. Another bill I introduced was H.R. 3485, the Trace Act, which sets up a food product traceability system so that we can trace where our food is coming from so that we can recall it and make sure it comes off of the shelves. In today's digital age, there's no reason we can't track food products from farm to fork. And the fact that many other industrialized nations are already doing it proves that point. And finally, we can't pretend to reform our food safety system while keeping in tact the complex regulatory structure in which 15 separate agencies share food safety jurisdiction. We must create a single food safety agency to ensure accountability once and for all. I want to thank you, Mr. Chairman, for having this hearing. I expect to hear the latest on what the FDA's doing to combat this crisis. I also am continuing to monitor the status, as you mentioned, of a laboratory closing plan because it makes no sense to consolidate food safety labs at a time like this. We need to get a grip on this, both legislatively and in an oversight way. And I welcome this additional hearing in our series of hearings. Thank you, Mr. Chairman. Mr. Stupak. I thank the gentlewoman. Mr. Burgess for an opening statement for 5 minutes. OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Burgess. Thank you, Mr. Chairman. And I appreciate you having the hearing today. So, Mr. Chairman, we've seen recall upon recall all summer long, consumer product safety questions, consumer confidence dives. The number of recalls this summer has been alarming. This committee must take an active role. We're here to provide oversight to safeguard America from dangerous food, dangerous consumer products. The public health and the public confidence are both at stake in this. You just can't help but notice that all of the products and all of the foods that turn out to be problematic, all emanate from a single foreign source. While I want to thank the leadership of this committee for holding this hearing, third in the series on the Nation's food supply, the subcommittee has been appropriately aggressive and pursued a bipartisan investigation on the matter. Really I want to urge my colleagues on both sides of the dais that this committee and the full Energy and Commerce Committee aggressively pursue legislation to deal with this problem. Chairman Dingell, of course, has introduced H.R. 3610. I don't know that that's a perfect piece of legislation, but I hope we get a chance to visit about that in both the subcommittee and the full committee. And whether we ultimately agree on all of the points or not, I thank the chairman for introducing the legislation on this important matter and certainly hope there will be an opportunity this time for some bipartisan interaction on what will be important legislation that will affect the course of this country for decades to come. Its intentions are good. It's always details, details, details, and again look forward to really aggressively working on that legislation. I think we need to look at how other Federal agencies have dealt with problems and what tools they have at their disposal and whether it would be appropriate for the FDA to have similar tools, similar authorities. I hope that today's hearing will help us further the goal of transforming the Food and Drug Administration because truly this is transformational. We're beyond the point of reform. Reform is, if you've got a little problem, you need to manage it around the edges. This is a big problem, and it is going to require true transformation of the Food and Drug Administration into an agency that can fully cope with the importation problems of the 21st century. They are not problems that were created by the FDA. They are problems that are created by where we are in the world right now, and the FDA right now needs to be able to respond to those problems. If the FDA needs additional authorities, needs additional resources to be able to truly protect Americans, then we need to have a frank conversation about this, and I look forward to engaging in a candid conversation with the witnesses today. I continue to be very interested. We heard from Dr. Bill Hubbard, former FDA associate commissioner of this committee on several occasions. His prior proposal, that has been discussed at length and mentioned in previous hearings, would grant the FDA the authority to embargo a specified food from a specified country much like similar authority to the USDA has in regard to meat and meat products. If this standard is good enough for meat products, then it makes sense that it should be good enough for all food and drink imported into this country. And Mr. Chairman, we might even argue that it also should apply to other imported goods, such as toys. While I had hoped to have legislation addressing Mr. Hubbard's concerns available to introduce, it has been tough sledding. There are a lot of things that I hadn't considered when I originally took that project on and my staff, my personal staff, took that project on. We've had some difficulty getting answers. It seems that those difficulties seem to be evaporating now. But I actually welcome the fact to have both the USDA and the FDA side by side on the panel today. Perhaps we can pursue some of those questions that have been particularly vexing. And certainly I welcome an open discussion regarding the proposal that I've had and Chairman Dingell's proposal. Again, Mr. Chairman, thank you for holding this hearing. And in the interest of time, I'm going to yield back the balance of my time. Mr. Stupak. I thank the gentleman. And Members should realize this is the third of five hearings we have scheduled. The next one will be November 1. It's going to be drugs that are imported from overseas. On November 13--that is a Tuesday--we are going to do it on domestic foods, going back to domestic food. It will be our second hearing on domestic foods. That hearing is a Tuesday. It is at 10:00 a.m. If you need us to adjust the time, such as Members like Mr. Waxman, Ms. DeGette or Mr. Burgess coming in from Texas, if you need us to shove that back an hour or so, we can accommodate Members. Some of us will be in on Monday. So think about it so we can accommodate everybody. Mr. Inslee, opening statement, please. OPENING STATEMENT OF HON. JAY INSLEE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON Mr. Inslee. Thank you. I appreciate the chairman talking about these other hearings because I think it's important that, while today we focus on the Chinese problem, that this is just one hole in a safety net that has many holes. The kids who were damaged by spinach, it wasn't from China. It was from fields in California, and I'm told we had more food rejected in our inspection process from India last year than from China. So I just don't think we can lose sight of the fact that this entire scheme needs to be changed, and I appreciate the chair's leadership on that. I hope today that we'll hear answers to three questions I'd like to pose. First, do we need to have at least as aggressive a food safety program as Hong Kong? We will hear testimony about the Hong Kong process that requires certificates to allow entry of at least Chinese imports. And the question arises, should we at least have as vigorous a program as they do? Second, I'd like to hear whether it's time to have at least as rigorous an inspection protocol from the FDA as the USDA. Why are we not providing the same level of protection for nonmeat and fish products? And I think we're starting to see hazards associated with those that would justify that action. And third, I hope we'll have a discussion of the plans or at least a discussion of the closure of labs at the very moment we have this continued increase in threats--and it is a great decrease in confidence; 70 percent of Americans now do not trust these overseas products. So I hope we'll have a discussion of that, what appears to me to be a very short-sighted effort. With that, I yield back. Thanks, Mr. Chairman. Mr. Stupak. I thank the gentleman. Mr. Waxman, an opening statement, please. OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Mr. Waxman. Thank you very much, Mr. Chairman, for your vigorous efforts in oversight in the area of the safety of food and drugs and other products that are consumed by the American people. Over the years, we have had a lot of hearings when there has been a scare but not a lot of sustained activity after the hearings to make sure that we do protect the American people from unsafe products. We are seeing the downside of two predominant views of our economy. One has been that we should rely more and more on a globalized economy. Well, the downside of that is that we don't have control, as we would like, for the evaluation of the safety problems when we bring in products from other countries. In many ways, we rely on these other countries to assure us that we are importing a product that is maybe not otherwise available here but is going to be safe when it is consumed here. The other theory that we are seeing the downside is deregulation. For years now, we've seen proposals to deregulate, to get government out of the way, to allow the private sector to solve problems. And thus, we now have an FDA with diminished resources to do its job, with inadequate authority to do its job. So for those who have argued that we need to deregulate, to starve the regulatory agencies, we are seeing the results come home. In the great tradition of oversight, this committee has sent our investigators to China. And what they've reported back to us is really pretty startling. They have indicated that what they have seen is that the Chinese food supply chains do not meet international standards. The Chinese Government is very concerned about bad press or bad appearances or embarrassment in the export market, and the branding of ``Made in China'' in a negative way around the world. But they have no meaningful regulatory system to make sure that the farming and food processing in China will lead to safety even for their own consumers. There have been many outspreads, wide outspreads of poisoning of Chinese from unsafe foods. So when they have problems, they don't do enough to stop the entrepreneurs, so- called, from smuggling in food supplies into the export market even if they are unsafe. Well, what can we do about this? We have had hearings, and we have certainly come to the conclusion the FDA is not doing its job. Well, we want to rely on an FDA that can and will do its job. So we need to give them the resources. We need to give them the authority. But other proposals have been put forward, such as the legislation by Chairman Dingell, to say that we ought to not just rely on inspections here in the United States but to try to ascertain that a country has a regulatory system in place to protect the supply that is going to be brought into the U.S. market. Well, that sounds like an ideal way to resolve things, but I don't think in the real world it's going to happen for quite a while. Then the legislation suggests that we ought to have the FDA certify individual marketers. Well, if that is what we are going to rely on, that is going to involve thousands and thousands of individual places to inspect. We have to deal with a modernization of a regulatory system, a modernization of an effort here in the United States to protect the American consumers. Our colleague, Ms. DeGette, just talked about how consumers welcome globalization when it leads to a wider variety of products that are not available and to lower prices for those products. But her consumers nor do my consumers want to have a lower price for a food product that may cause genuine harm. I am encouraged that we are holding hearings; we are looking at legislation, not only for imported product safety but for domestic safety as well. I commend you, Mr. Chairman, for your efforts. We have got to make sure that we are not just holding hearings but that we follow through so that the daily press that we see of food problems becomes something that is dealt with in a realistic way. Thank you. Mr. Stupak. Thank the gentleman. The chairman of the full committee, Mr. Dingell, for an opening statement please. OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Mr. Dingell. Mr. Chairman, I thank you. And I commend you for holding this hearing and for the superb leadership you are giving in terms of protecting the American consumers. I also want to commend you for the excellent and far-reaching investigation into the effectiveness of our laws and the administration activities in support of those things. The food safety challenges our country now faces and the questions that we confront with regard to prescription pharmaceuticals, plants and devices is a matter of great concern to this committee. As we have seen in prior hearings, food safety affects us all. But it is particularly most dangerous to the most vulnerable, the poor the young the very old and those with compromised immune systems. Today we focus on food imports, not only from China but also from other countries with regulatory systems that are not the equivalent or even close to ours. Importing food from such countries is risky to begin with and even more dangerous if the resources for the regulatory agencies entrusted with ensuring their safety are bigger and their management is passive or ineffective. Mr. Chairman, we sent committee staff, as you know, to China to help us understand whether importing food from that country made sense, given the spate of recent incidents involving tainted food imports. By sending committee staff to look at these problems firsthand, we have gained insights that are unique from other congressional committees now looking at food import safety. I very much look forward to the staff's testimony today. I am interested in the analysis of our expert witnesses, Mr. Rice and Dr. Martin, regarding regulatory efforts of Hong Kong and Japan, which import a substantial amount of the food that they use from China. The subcommittee will also hear from representatives in the Department of Agriculture and the Food and Drug Administration, the primary regulatory agencies that ensure the safety of our food imports. I look forward to comparing and contrasting their budgets and their efforts. I especially look forward to hearing from USDA regarding efforts to protect Americans from contaminated beef, pork, chicken and eggs. I understand their system is far more selective as to who can import into this country and from where and that the USDA inspects a larger portion of the imports that they are responsible for regulating than does FDA. Most of all, I look forward to the testimony of FDA witnesses today. Two weeks ago, when the FDA was called in to discuss food safety in the context of the bill that you and I and other members of this committee have offered, Mr. Chairman, H.R. 3610, they sent one of the least-prepared witnesses ever to testify before this committee. That FDA official, Dr. Lutter, repeatedly told us how ignorant he was of the most basic facts regarding the food import crisis. I hope that we will have better performance from the FDA today. I also trust that FDA witnesses are not going to try to sell that old often repeated falsehood that we can do more with less. The only thing FDA has established with regard to this particular point is that they can do less with less. FDA needs resources to deal with the cavalcade of imports from China and other countries that cannot or will not ensure the quality of their food imports to the United States. I intend to see that the FDA gets the budget that it so sorely needs. Finally, Mr. Chairman, I understand that you intend to hold hearings in November dealing with the safety of drug imports and the inadequate regulation of our domestic food supply. I endorse your plans, and I commend you for doing this because it is an activity by this committee desperately needed. The bill that you and I and other Members of this committee sponsor addresses these matters as well as providing the crucial resources necessary to strengthen the import protections. I expect that the hearings today and in the future will help us to refine the legislation. I've always found that legislation informed by the work of the Subcommittee on Oversight and Investigations makes for far better law and far better public policy. I also look forward to contrasting and comparing budgets and efforts at FDA. I especially look forward to hearing from USDA regarding its efforts to protect Americans that we so desperately need. In any event, Mr. Chairman, if anyone here has been to China, many of us have, they will know that you have to be darn careful about what you eat over there. I see nothing which has changed, the quality of the food that they send us, from the quality of the food which they send to their own people. And I intend to see to it that the best food and drug law in the world, which we have, is properly administered, properly enforced and properly financed. I commend you for these hearings. And I thank you, Mr. Chairman. Mr. Stupak. I thank the gentleman and thank the chairman of the full committee. And thank you for your continued support of our efforts as we reach out globally to address this issue of food imports. Next I would like to hear the gentleman from Texas, Mr. Green, for an opening statement, please. OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Green. Thank you, Mr. Chairman, for holding this additional hearing and also the announcement for the hearings later. I would also like to thank the chairman of our full committee for authorizing the staff delegation trip to China over the August recess. I am grateful for the ONI staff for making the trip so we can learn firsthand about the regulatory scheme present in that country which is one of the top food importers to the U.S. We cannot necessarily dictate how food is regulated in another country. This knowledge of Chinese regulation will help us identify the safety gaps in China and implement the necessary safeguards to protect the American people from dangerous contaminated food products bound for our country. As we examine the Chinese regulatory scheme for food, we should keep in mind that China is not our country's top food importer from the developing world; Mexico is. The problems also are not coming disproportionately from China. According to FDA import alerts, there are 20 Mexican firms on import alerts while there are 16 import alerts facing Chinese firms. The monthly tally of imports refused at the border also indicates that Mexico, China and India are at the top of the list of oasis refusals by country in any given month. Whatever policies we implement based on our understanding of the Chinese system must be applicable to all our trading partners, including Canada and Mexico, which are the top exporters of agriculture and seafood products to the U.S. The staff investigators' trip to China shed light on the fractured regulatory framework for food in China and the numerous agencies involved. The lengthy supply chain and food processing procedures in China give us important insight on how these problems arise. In our country, we celebrate the family owned small business and consider a family's entrepreneurial success a realization of the American dream. As the investigators pointed out in their report, however, family farmers in China often face difficult economic conditions and downward pressure on prices to make crop survival the highest priority, even at the expense of safety. With such fragmented regulation, a Chinese farmer is probably willing to take that gamble. It appears the Japanese have protected their citizens from this problem by allowing only Chinese imports from a certain number of certified producers who have met their quality standards. Hong Kong has taken a different route by implementing a robust registration and inspection regulatory framework. It is unclear whether any of these systems can be applied to a country as large as the United States and with such demand for the products. We can certainly learn from them and determine what elements can be workable for the U.S. supply system that is in dire need of improvement. And as my colleagues have pointed out, it is not just our imports. Whether it is hamburger meat, whether it is spinach, whether it is any other issue, we need an active and robust FDA. And I am glad that the chairman of the full committee is committed to providing the resources to the FDA so they can do not only what we expect them to do on the drug side but also on our food safety. Thank you, Mr. Chairman. I yield back my time. Mr. Stupak. I thank the gentleman. Mr. Melancon for an opening statement. Mr. Melancon. Thank you, Mr. Chairman. I would just submit my remarks for an opening and reserve my time for questions if you would. [The prepared statement of Mr. Melancon follows:] Prepared Statement of Hon. Charlie Melancon, a Representative in Congress from the State of Louisiana Mr. Chairman, Thank you for holding this hearing today. I am quite concerned about the lack of screening of 80 percent of the United States' food supply. My district, which depends largely on the fishing industry--shrimp, crawfish, fresh caught fish, is struggling to compete with imports from foreign countries that do not have the same food safety standards as we have in the United States. Countries like China, Taiwan, and Vietnam--just to name a few--import seafood that is produced in farms, not fresh caught. Catching wild shrimp and fish is much more labor- and capital-intensive, so fresh caught seafood is more expensive than farm raised. Farms try to produce as much product as possible, so they overpopulate ponds. Because the ponds have no fresh water circulation, they become filled with bacteria. The farmers then pump antibiotics and other chemicals into the water to kill the bacteria. These chemicals have been shown to cause cancer in animals and humans. Since the Food and Drug Administration only tests 1 percent of food imports, Louisiana's Department of Agriculture has taken it upon themselves to test for these dangerous chemicals. They have repeatedly found concentrations of chloramphenicol and fluoroquinolones, among other chemicals, in imported seafood--particularly from producers based in China. Despite evidence of chemicals and antibiotics in imported seafood, the FDA still allows tainted food to enter the United States. I am happy that the FDA finally made an Import Alert for farm-raised catfish, basa, dace, eel, and shrimp from China in June, but we've known about tainted and contaminated imports from China for years. Louisiana's Department of Agriculture has also found evidence of chemicals and antibiotics in crawfish tail meat from China, yet the FDA is still allowing this tainted meat to enter our food supply. Furthermore, an Import Alert does not necessarily mean that these tainted products will be prevented from entering the United States. Rather, an Import Alert means that field agents detain the product--not destroy it or return it to the originating country--and wait for the importer to show that the shipment is not tainted. The FDA requires an independent lab test for proof, but the FDA doesn't certify labs, so anyone can open a lab and provide test results. These are just a few of the problems that we in this committee have discussed previously and will continue to examine until the food we import is safe. I am seriously concerned about the safety of food imported from countries that lack food safety standards equivalent to those in the United States and hope that we can soon find a better system for monitoring food imports. Thank you, Mr. Chairman. ---------- Mr. Stupak. Very good. That concludes the opening statements by members of the committee. I will now call our first panel of witnesses to come forward. On our first panel, we have Mr. David Nelson, senior investigator for the Committee on Energy and Commerce; Mr. Kevin Barstow, investigative counsel for the Energy and Commerce Committee; Mr. Richard Wilfong, investigator with the Energy and Commerce Committee. It is a policy of this subcommittee to take all testimony under oath. Please be advised that our witnesses have the right under the Rules of the House to be advised by counsel during their testimony. Do any of you wish to be represented by counsel? Indicating no one wishes to be represented by counsel, please raise your right hand to take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect the witnesses have answered in the affirmative. You are now under oath. And Mr. Nelson, I understand you are going to give the opening statement, a 5-minute opening statement. You may submit a longer statement for inclusion in the hearing record. Mr. Nelson. STATEMENT OF DAVID NELSON, SENIOR INVESTIGATOR, COMMITTEE ON ENERGY AND COMMERCE; ACCOMPANIED BY KEVIN S. BARSTOW, INVESTIGATIVE COUNSEL, AND RICHARD A. WILFONG, INVESTIGATOR Mr. Nelson. Thank you, Mr. Chairman. Good morning, I am David Nelson, an investigator with the Committee on Energy and Commerce. I am accompanied by Kevin Barstow, counsel, and Richard Wilfong, an investigator with the committee staff. Mr. Chairman, you and Chairman Dingell dispatched us to China on August 17 to ascertain whether food stuffs from that country could be imported safely into the United States. We met with Chinese and Hong Kong government officials, U.S. Government officials, American and other multinational executives involved in processing and distributing food in China and Hong Kong and reporters from bureaus in Beijing and Hong Kong that cover food issues for their media outlets. The report of that trip is attached to this summary statement. Based on information gathered before and during the trip, the staff made the following observations: First, the Chinese food supply chain does not meet international safety standards. It is in fact responsible for very serious domestic Chinese food-poisoning outbreaks. Second, the Chinese Government appears determined to avoid embarrassing food safety outbreaks in its export markets due to the damaging and potentially lasting effect this would have upon the Made in China branding. Third, the lack of meaningful internal regulation of farming and food processing in China, the advanced development of the document counterfeiting industry and the willingness of some entrepreneurs in both China and the United States to smuggle foodstuffs that do not meet quality standards necessitates a much more vigorous program of inspection and laboratory testing in China and in U.S. ports of entry than the Food and Drug Administration has been willing or able to pursue today. The responsibility for quality assurance both of imports and exports rests with the AQSIQ in China, the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. The AQSIQ officials issued a white paper on August 17, 2007, which is included in the exhibit book dealing with food safety. This paper details China's export quality assurance program. While in China, we had an opportunity to discuss the components of this program with AQSIQ officials as well as other Chinese agency officials. We were advised that a sample from each lot of product for export is pulled by a government inspector and tested in a government laboratory to ensure it meets Chinese standards and the standards of the importing country. Export certificates are then granted by the local Chinese inspection and quarantine CIQ offices, CIQ or local municipal equivalents to AQSIQ. We are shown how importers' paperwork is joined with laboratory test results before the certificate is issued. When the certificate is issued, the information is sent to the port of exit electronically to ensure that the fiscal goods correspond to the export certificate before loading. The Chinese position is that theirs is a closed system that ensures the safety of foods that bear the CIQ certificates and seal. Today, FDA has refused to acknowledge the Chinese certificates. If the Chinese system worked as described, it would be a very safe system. However, we did not find any American or other multinational executive operating in China that believed that China has a competent independent inspector overseeing each of the 12,714 plants that are approved for export or even of the 3,700 plants that according to Chinese officials are fully HACCP controlled. Nor did we find anyone that believed that every single lot was sampled. Finally, it was widely believed that the export certificates were subject to counterfeiting. There was agreement among everyone we talked to about the sincerity and scope of the AQSIQ's efforts but much less enthusiasm about the willingness of local CIQs to follow the central government's dictates. And we were told it's at the local level where the system succeeds or fails. We made inquiries about two possible models. One of the models, the Chinese food exports to Hong Kong, was broached directly with the Hong Kong Government. The other, the Chinese food delivered to Japan, was discussed with knowledgeable sources but not the Japanese Government due to the time limitations of the trip. An overview of their findings of our findings regarding these two models is presented in the trip report. Can food be imported from China safely? The Japanese and Hong Kong models are each safer than the FDA's system for regulating food imports. The Hong Kong system involves massive sampling and thus may not be practical for an economy of our size. Last year, the Hong Kong Government tested in their laboratory 64,000 samples. If we were to test an equivalent proportion of samples to a country the size of the United States, it would be over 2 million in FDA labs. That simply is so far beyond the capacity that it's hard to even imagine if we could build that much laboratory space very quickly. The Japanese system of inspecting a very limited number of facilities that are permitted to supply food to China does appear to offer a much better control system than currently employed by the FDA. But the Japanese also inspects and tests 15 percent of their food imports. We inspect 1 percent and test a fraction of that. However to the extent that the Chinese products for the Japanese market are insulated from excessive downward pressure on prices--and that's a real problem, the incessant pressure on downward prices on people that are producing at the margin causes a lot of shortcuts to be taken in a lot of products over there--to the extent they're insulated from downward pressure on prices, the Japanese consumers pay for the added safety in the form of somewhat higher prices. The size of the price effect is not known. At a minimum, it would appear the U.S. could cut safety risks significantly were FDA to limit food imports to China to those firms that have obtained the appropriate certificates from the Chinese Government. For all the reasons noted in this report, such certificates are no guarantee of safe imports, particularly if there's not an electronic transmittal system in place of the paper certificates. However, the absence of such certificates most certainly means the Chinese quality control system has been evaded by their exporters. Mr. Chairman, thank you for the opportunity to testify before this subcommittee. Mr. Barstow, Mr. Wilfong and myself look forward to answering any questions you or other Members may have about our testimony or the investigation. [The prepared statement of Mr. Nelson follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you, Mr. Nelson. We'll begin questioning. We can go 5 minutes, maybe we can go two rounds. We do not have votes today, so we should not be interrupted. Mr. Nelson, in your report, it states that the USDA does not permit any beef, pork, chicken or eggs into the U.S. from China. You say that it would be impractical for the FDA to take the same stance. Would you explain that? Mr. Nelson. Well, yes, there's a far different matter excluding four specific products versus all the rest of the food products. And we say, and truthfully, that USDA has responsibility for 20 percent of our food supply. But it's 20 percent by value. It's not 20 percent by volume or by number of products. If we were to exclude all food products from China, it would have substantial effects on the economy of the United States. We get a large proportion of fish, of amino acids, of vitamins, of intermediate products like wheat gluten and a lot of finished products. I mean, and those exports to us are growing. Mr. Stupak. In your opinion, based on the last answer then, in your opinion, are imports from China more or less dangerous than food from other parts of the world, such as India, Mexico or the Dominican Republic, all which are important food suppliers to the United States? Mr. Nelson. No, not necessarily. We have a substantial portion of the rejections of foods for--because they're unsanitary, contaminated, decomposing, from these other countries that have less developed economies and less developed regulatory systems. China is certainly one of the problem countries. But it is only one of the problem countries. Mr. Stupak. China indicates they will certify the food. That is, certified to their standards, not necessarily the country that they're exporting the food to, in this case the United States. It's not U.S. standards. When they certify, it is to the Chinese standards. Mr. Nelson. They claim it is the U.S., it is the standards of any country for which they're exporting. Mr. Stupak. That's what they claim. But what did you find when you were there? Mr. Nelson. We found laboratories, at least the one we looked at in Beijing is comparable to the FDA laboratories we have here. Mr. Stupak. How many of those type laboratories did they have? Mr. Nelson. They claimed to have 323 laboratories. Mr. Stupak. Three hundred and twenty-three laboratories? How many farms supply those laboratory samples from their farms? How many farms are there that grow food for export? Mr. Nelson. They claim that they've approved some 360,000 hectares of land, farm land for export. Mr. Stupak. Three hundred and sixty hectares, but how many farms? Mr. Nelson. Three hundred and sixty thousand. I'm not sure how many farms that translates to. Mr. Stupak. But a hectare can be as large as a basketball court, or it could be much larger, can it not? Mr. Nelson. It could be. But it could be as small as a basketball court. Much of the Chinese domestic food supply anyway--we're talking about literally hundreds of millions of farmers---- Mr. Stupak. Correct. Mr. Nelson. Are from these very, very small parcels of land the products of which are then gathered by intermediaries and consolidated. There's simply no way that the Chinese Government can have control over the conditions of farming on so many farms. Mr. Stupak. Well, I understand the central government in China does not have complete control of what happens at the provincial or the local government level. So what does that mean for food safety if you have tens of millions of farms, which first contact would be local government, then you have provincial government; then you have the central government. You have three layers of government there. How do they work government to government? Mr. Nelson. Well, I don't think anybody knowledgeable about the system can say that the Chinese food supply is safe, even their export systems. Mr. Stupak. Who puts forth the regulatory regime on food safety? Is it the central government, provincial government or the local government? Mr. Nelson. The provincial and local governments are where the rubber meets the road. They're the ones that are issuing certificates. Mr. Stupak. So can each local government or each province have a different regulatory scheme in which chemicals or pesticides they use? Mr. Nelson. They are bound by a common national scheme, which is to meet the Chinese national standards and the importing country's standards. But whether or not they do, whether or not those regulations are enforced is very problematic. Mr. Stupak. On reading your report, I found a lot of issues that--not only from government to government but government to the farmer, there's less regulation. And when we deal with the certification, China has a rather sophisticated counterfeiting--is that what you found? Mr. Nelson. There was unanimity on virtually everybody outside of the Chinese Government themselves as to the quality of counterfeiting. And it's not limited to documents. But modern publishing techniques make counterfeiting very, very easy anywhere in the world. And the Chinese technology in such matters is as good as anywhere in the world. Mr. Stupak. Well, I have many more questions for Mr. Barstow and Mr. Wilfong. My time's up. Hopefully, we'll get a second round of questions in. Mr. Whitfield for questions, please. Mr. Whitfield. Thank you, Mr. Chairman. Mr. Nelson, in your testimony, you state emphatically that the Chinese food supply chain does not meet international standards. And it is, in fact, responsible for very serious domestic Chinese food poisoning outbreaks. Now, one of the areas that I'm a little bit puzzled about relates to this concept known as equivalence. And that basically means that although food products imported into the United States must meet the same safety standards as domestically produced foods, international trade rules permit a foreign country to apply its own differing standards, regulatory authorities in institutional systems in meeting standards under this internationally recognized concept known as equivalence. And so my question is, if the Chinese food system does not meet international standards even though we can apply this equivalence standard, how is it that we're able to bring their food into America in a safe way? Mr. Nelson. Well, U.S. law is bifurcated in that regard. USDA, for meat and eggs, has an equivalence standard. And as a consequence, we import no eggs, pork, chicken or beef from China. And it's unlikely---- Mr. Whitfield. Because they don't meet the safety standards? Mr. Nelson. They don't meet the equivalence standard. Mr. Whitfield. All right. So we don't allow any meat, poultry products, eggs from China? Mr. Nelson. Right. That same standard is not in the Food, Drug and Cosmetic Act. Mr. Whitfield. The same standard is not in the Food, Drug and Cosmetic Act? Mr. Nelson. That's correct. Mr. Whitfield. So the USDA, their inspection responsibilities of the meat products, they can prevent these items from coming in. But you are saying the FDA does not have the authority to prevent---- Mr. Nelson. The Food, Drug and Cosmetic Act does not have an equivalence standard. Now, there are very strong authorities for--and very strong authorities and much discretion for FDA at the border, much more than there is within the United States. But there is no equivalency standards. So FDA does not go over and determine whether or not the spinach or fish or wheat gluten or toothpaste from China is produced under standards that are equivalent to the United States. Mr. Whitfield. Well, your statement, that's a pretty strong statement. I mean, you all went there, and you met with officials, and you looked at processing plants and facilities. And you make the statement, the Chinese food supply does not meet international safety standards. Mr. Nelson. That's right. Mr. Whitfield. That's all food; correct? Mr. Nelson. That's all food, in terms of the country as a whole. Now it's really important to understand that the food for export is handled and treated by the government much differently than food for domestic consumption. And USDA's laws, as I understand it, or law, requires an evaluation of the entire system of growing chickens, for example, plucking chickens, processing chickens and preparing them for consumption, whether for export or for import. And under those standards, it's hard to imagine China reaching an equivalence level in my lifetime. Mr. Whitfield. Yes. Mr. Nelson, we're going to have some other people testifying today from FDA and Tyson's and others who are experts in this field. But you have a long history and background in this area also, and certainly one of the experts on this committee. But if you were speaking to a Rotary Club say in the State of Kentucky and you were going to just make a statement to the members of that Rotary Club if they ask you a question, ``do you think it is safe to eat food from China that comes into the U.S.,'' what would your answer be? Mr. Nelson. I would say that you're taking your chances on any imported food and some processed foods within the United States. But those chances of any single person being seriously harmed from food are really small. Mr. Whitfield. OK. Mr. Nelson. Food of any kind. Mr. Whitfield. My time is expired. Mr. Stupak. My time has expired. Thank you, gentlemen. Mr. Dingell for questions, please. Mr. Dingell. Mr. Chairman, I thank you. Gentlemen, can FDA under current circumstances protect American food supplies from unsafe imports with the resources which it has? Mr. Nelson. That would be an emphatic ``no.'' Mr. Dingell. Gentlemen, should we continue to allow food imports to enter through 321 ports of entry? Mr. Nelson. That would not appear to make any common sense at all. We have 321 ports of entry in the United States and the Food and Drug Administration doesn't cover but a fraction. Mr. Dingell. How many of the Nation's ports--air, sea and land--are staffed by FDA personnel? Mr. Nelson. They tell us it is 90 ports, but it is highly doubtful that that is 24/7 coverage of those ports. Mr. Dingell. What percentage of imports are checked at these 90-some ports, and what is the success in terms of protecting consumers. Mr. Nelson. Well, the agency says they inspect less than 1 percent. They test a fraction of what they inspect. And I think there is still substantial risk. I mean, they don't make a serious--they don't test enough to make a statistical statement about the safety of food. I mean, the Japanese test 15 percent of a highly regulated import system that goes to the countries which supply the food. Inspections there. And they still test 15 percent, because that is a large enough sample for them to have confidence that the food coming in is safe. But our tests are so meager it is hard for me to imagine anybody having much confidence in the results of the FDA inspections. Mr. Dingell. Is the Chinese food production system comparable to the United States system? Mr. Nelson. No. Mr. Dingell. What are you telling us there? Mr. Nelson. When China ceded to the WTO, and perhaps before, the collectivized farming systems collapsed. And you have now literally hundreds of millions of small farm--some, as the report said, no larger than the size of a basketball court, producing the food supply. You have a lot of Chinese bureaucrats, but nowhere near enough to police the number of farms that they have and the number of small processors, which is another issue. I mean, most of the food processed in China, we are told, is by family processors, plants that employ less than 10 people, that are just as marginal as the farms they get the produce from. Mr. Dingell. Is the Chinese regulatory system, in terms of protecting consumers' health and safety, comparable to that in this country? Mr. Nelson. Not at all. Mr. Dingell. Why do you say that? What percentage of the foods that the Chinese produce are inspected or undergo some kind of a safety procedure in China with regard to domestic consumption or with regard to export? Mr. Nelson. I would say virtually none with regard to domestic consumption. Mr. Dingell. Is it true that we can import food from China safely under current Chinese practices and under current U.S. practices? Mr. Nelson. No. Mr. Dingell. You have discussed briefly how Hong Kong protects the food supply. Would you like to amplify on that? Mr. Nelson. First of all, Hong Kong is a city of 7 million people. It is about the size of Chicago. It is an administrative district of China itself now, after the British left in 1997. It is under special administration. It has got 40 more years to run before it is fully integrated into the governmental system of China. It keeps its own tariff territory. Importing in Hong Kong is separate and distinct from importing into China, and China imports into Hong Kong. They grossly limit the number of ports of entry for fish, or other foods being brought in by sea, to perhaps two or three; land, one or two. They test intently because the SARS and other outbreaks threaten not just the health of Hong Kong's citizens, the physical health, they really have threatened the economic viability of that entity. So food safety is a huge issue in Hong Kong. They do a lot of testing, 64,000 samples last year, of which only 0.3 percent were out of spec. That is partly because the Chinese themselves are very, very concerned that food outbreaks not occur in Hong Kong. It reduces the political stability of the administrative entity, and they are constantly aware of and concerned about the level of engagement of the Hong Kong citizenry in policy issues and just as soon things keep as quiet as possible. Mr. Dingell. Mr. Chairman, I have used my time. I thank you for your courtesy. Mr. Stupak. Thank you. Mr. Burgess for questions, please. Mr. Burgess. Thank you, Mr. Chairman. Mr. Nelson, you and members of your staff and minority staff who were there in China--and you have partly already answered this question--but China internally has a domestic problem with their food supply? Mr. Nelson. A serious problem. Mr. Burgess. And did you see evidence of that in either news reports or did people talk about that when you were there? Mr. Nelson. Yes. Mr. Burgess. Many years ago, probably 15 years ago, as a physician I went on a trip to China with some other doctors, and I remember getting very ill when I was there in China. So I was wondering, what did you and your staff eat? Mr. Nelson. We ate what was served to us. Mr. Burgess. Are you OK? Mr. Nelson. I was. That is not true of everyone at this table. Mr. Burgess. And I note the absence of the minority staff. Were they your testers? Mr. Nelson. We have always joked about taking the minority along to taste the food, yes. Mr. Burgess. And, of course, we are teasing about it, but I remember over there seeing some of those small farms that you talk about, the size of basketball fields. And at the time, the collective system was still very much up and running, but these were small individual plots that were allowed, and people were allowed to develop, as entrepreneurs, small farms. There wasn't much in the way of automobile or truck traffic in 1993, but there was a lot of bicycle traffic. So there was, in my mind at least--and I wasn't a student of the issue by any means at the time. But you had these small farms that were irrigated and fertilized essentially by raw sewage. And that raised a host of questions. And then to get these products to market, they were put on the backs of these bicycles, in large baskets or things that would then run along the road, and all of the water, of course, whipped up by the bicycle wheel splattered up on the basket. And you couldn't help but wonder if a bacteria or two would find its way through the basket weaving. So I did wonder about that at the time. So that is why I was interested if you found the problem was still, in fact, still present or maybe worse than what I saw. Ranking Member Whitfield asked some questions about equivalency, which I think are particularly relevant to the discussions that we are going to have not only today but in the hearings to come, whatever legislative markups we have in the future. Why do you think there is no equivalency standard written into the Food and Drug Act? Mr. Nelson. I mean, I think it is a matter of the way that the commodities have been treated historically. I think there are far more serious outbreaks regarding meat historically in the United States than there have been for other products. Mr. Burgess. Well, I have, I guess, a paper from the United States Department of Agriculture, the Food Safety Inspection Service Office of Internal Affairs. Under ``definitions,'' equivalence is defined as a state wherein sanitary measures applied in an exporting country, though different from measures applied in the importing country achieve, as demonstrated by the importing country, the importing country's appropriate level of sanitary protection; hence, the term ``equivalence.'' That seems like a pretty reasonable standard that the USDA applies. Is there some problem from just a trade perspective that prevents us from having an equivalency standard in the Food and Drug Act? Mr. Nelson. Well, we would cut off a substantial portion of food imports from the world if we had such a standard. The USDA is here today and we invited them--Mr. Stupak invited them specifically so we could get a better understanding of the two systems. Mr. Burgess. Correct. And I am anxious to hear that--on page 14 of this document that has been provided to me. Paragraph 8, ``equivalence verification,'' they give their equivalence triad a little description or drawing of how document analysis is balanced with port-of-entry reinspection, balanced with on-site audit. And that just seems so reasonable applied to what we are talking about today that would prevent problems. Yes, expensive perhaps, but we see the Japanese are willing to pay that premium. And I have got to tell you, if I went to Kentucky Fried Chicken tonight and they said, You can have this bucket of chicken for eight bucks but you are maybe going to get sick, or you can buy this one for nine bucks and you will probably stay well, I'll take the $9 chicken, please. It doesn't seem that from the consumer side--we sat here and saw just really moving testimony from the family whose daughter had the renal damage from eating the spinach, and that wasn't even an imported product. That, at least we were told, was grown in the United States. It was not imported. I have got to believe that consumers would go to the ends of the Earth not to bring bad products home to feed their family. I mean, it is not even common sense. I don't even think we would have to debate it. Let me just ask you one question before my time expires. I am interested in the comment you make on the very last page of your testimony in talking about the Hong Kong--the methods they use there would not be viable even if the political environment were not a factor. How is the political environment a factor in the Hong Kong-type of regulation? Mr. Nelson. Well, the Chinese Government generally, and the Guangdong Government specifically--which is a province across the border from Hong Kong--are very concerned that Hong Kong be stable. And bad food, particularly poultry coming in from China, destabilizes the--it is not a colony anymore-- administrative district much more than they would like. For example, the person with food safety responsibility in Hong Kong told us that if an import--and again, they test so much. If that 0.3 percent that is out of spec comes in and is just marginally out of spec, the central government in Beijing will shut down the ability of that food processor or that farm to ship to Hong Kong or anywhere else until the problem is taken care of. Mr. Burgess. Mr. Chairman, I know my time is up, but that is such an important point. They have the ability to hit the red button on the conveyor belt, stop the process so no one else gets sick. And really what I'd like to see, whatever we do legislatively, I want us to have that red button in this country for our consumers. And I will yield back the balance of my time. Mr. Stupak. I thank the gentleman. And country-of-origin labeling we have been trying to do since 2002. Hopefully the administration will allow that in, so we know if it is an $8 bucket of chicken or a $9 bucket of chicken, so we know. Second, the poultry issue in Hong Kong and the Guangdong province is because of the bird flu and SARS and all the other problems we face. Why is it there, but not in the rest of the world where it doesn't seem to be concerned about it---- Mr. Burgess. I do need to make a comment about the country- of-origin labeling, because Dr. Hubbard addressed this. When you have got Canadian olive oil, unless global warming is a lot worse than I thought, you can't have Canadian olive oil if you have got appropriate country-of-origin labeling. Mr. Stupak. But you certainly wouldn't know where the poultry, the beast, the eggs and all the way down the line, where it comes from. Mr. Burgess. Country-of-origin labeling is meaningless because the---- Mr. Stupak. Let the consumer decide. Mr. Burgess. If you have Canadian olive oil--clearly there are no olives grown in Canada. How can you have Canadian olive oil, again, unless Al Gore was absolutely right. I yield back. Mr. Stupak. Ms. DeGette for questions. Ms. DeGette. Thank you, Mr. Chairman. Mr. Nelson, you had told several other members that you toured a food laboratory in Beijing, part of the China inspection and quarantine offices, one of those. I take it that those offices are roughly the equivalent of an FDA district or regional office with a lab; is that right? Mr. Nelson. That is correct. Ms. DeGette. Can you talk about what you saw at that food laboratory during your visit to that lab? Mr. Nelson. Well, none of us here is a scientist, much less a food scientist. But as you are aware, we have been to a number of FDA labs during the course of this investigation, particularly those that the FDA has threatened to shut down, And we have some acquaintanceship with what the various and sundry machines look like. And the Beijing CIQ lab was equipped, the visual opinion of a nonscientist here, was equipped at least as well as any FDA lab we saw in the United States. And we have no reason to believe that their food scientists are any less qualified. The question is: Is Beijing atypical? And the response is ``probably.'' Ms. DeGette. It is atypical? Mr. Nelson. Yes. Ms. DeGette. And why do you say it is probably atypical. Mr. Nelson. Because everyone--not everyone. People we talk to in the U.S. Government or our multinational corporations that have businesses throughout China that have knowledge of the way things operate throughout China believe that the quality of inspection, the quality of sampling, the quality of regulation varies widely among the provinces. Ms. DeGette. How many of these labs are there throughout China? Mr. Nelson. The Ministry of Agriculture told us there were 323 labs capable of certifying that food meets international standards. When we got talking to the AQSIQ, they reduced that number to 50. Ms. DeGette. What is the AQSIQ? Mr. Nelson. That is the agency in China responsible for food exports. Ms. DeGette. And what did they say? Mr. Nelson. They said 50. Ms. DeGette. Fifty. And you don't have any idea what the staffing levels or the technological levels of those offices are? Mr. Nelson. No. Ms. DeGette. Now, did you talk to the Chinese about the problems we have been having here, in particular the melamine and the wheat gluten? Any of you? Mr. Barstow? Mr. Barstow. Yes. Ms. DeGette. How did they explain that? Mr. Wilfong. Mr. Wilfong. Yes, ma'am. The wheat gluten--we had a long discussion with AQSIQ, with Vice Minister Wei, and it was repeatedly brought up that while China is willing to certify-- they are willing to certify their food exports, which they require all their food exports to be certified, tested and certified as food, the wheat gluten incident, the melamine and wheat gluten was a way since the U.S. doesn't recognize the certification, the FDA doesn't require it for imports from China, so therefore it is not looked for on the paperwork on this end. The wheat gluten was actually exported from China as industrial use. Ms. DeGette. So they didn't consider that to be food? Is that what you are saying. Mr. Wilfong. On their end it was exported as industrial use, not as food. And then the disconnect between the two systems on this end--since that certification isn't required and looked for for a food import on this end, it was actually imported as a food product;. Ms. DeGette. So it was a problem in the two countries' standards in what it was called and what was required to be reported? Mr. Wilfong. Yes, ma'am. And that is their main contention, is that they are willing to certify that there are exports of food, that they do certify all food they export. Yet our lack of recognition and requirement for these certifications leaves a big loophole for valid companies to actually import into the United States or export to the United States. Ms. DeGette. They say that is not their problem if there is a loophole. That is not their problem. Mr. Wilfong. They recognize the problem. We probably had a 1-hour discussion with the vice minister and they brought it up three times, that they really wish we would recognize their certifications. They are doing their work on their end; we are just not requiring that certification paperwork on our end. Ms. DeGette. Yes. I mean, what about the processing system? I mean, that is at the lab. What about coming up to the export level? Mr. Nelson. What their system is--and we watched this in the Beijing CIQ--an export certificate has to come from a farm or food processor that is approved, registered and approved for exporting, and that requires some form of local inspection. So only a certain number of entities can bring a request for an export certificate to the CIQs. And allegedly, a CIQ inspector samples the proposed lot from the lot, brings it to the CIQ laboratory where it is then tested to both Chinese and international standards. If it meets those standards, it is granted a certificate and that information is transferred electronically to the proposed port of exit so that people can feel assured that what has been tested is what gets loaded. Now, if the system worked like that, it is a very safe, closed system. No one that we talked to in the industry really thinks that it works that well. But it certainly works better than products that are exported from China without those certificates. Ms. DeGette. Thank you. My time has expired. Mr. Stupak. Thanks, Ms. DeGette. Mr. Inslee for questions, please. Mr. Inslee. Thank you. I appreciate Ms. DeGette's questions about this not accepting or reviewing the Chinese certification process, which apparently was one reason for the melamine problem, because there is a disconnect. What possible reason is there for us not requiring at least that? Even if the Chinese system internally is ineffective, or at least not totally proficient, why wouldn't we at least require their certification process to be complied with before we accept any product that could end up in our food chain here? Does that make any sense? Mr. Nelson. No. We posed that question to some of the people that are engaged in negotiations, with HHS on FDA's behalf, with China right now. And the responses we got were, Well, we might not want to exclude small farms and small processors from exporting to the United States; that somehow or another that was ideologically unacceptable; and the Chinese could use it, possibly to exclude American firms that wanted to set up operations in China for export to the United States. These were some of the excuses. But we have FDA witnesses. You best put those questions to them. Mr. Inslee. But these are excuses by our side of---- Mr. Nelson. By our side. Mr. Inslee. Do we do that in any other context for other countries? To me it is difficult to understand in any country that has any regulatory system, to not at least allow that minimal level of inspection to require that. Do we do that in any other context? Mr. Nelson. None comes to mind. What's important about the certification system in China is that it excludes almost all producers--it is a very small percentage of farms and food processors that qualify for those export certificates. It doesn't mean that the food they produce is going to be 100 percent safe or 100 percent inspected, as the Chinese Government maintains it is. But at least you are not getting it from the 90, 95 percent of the food industry in China that doesn't go through the system. Mr. Inslee. And do you sense one of our failures to require that is actually some fear that American firms would be disadvantaged somehow? Mr. Nelson. That is one of the excuses that we heard. I don't think that the administration has really thought this through. At least the people we were talking to didn't seem to be aware of how the system works, for example. Mr. Inslee. If you were going to rank the top three priorities from your experience in China for us to adopt, where would you put them? Let me ask it a little easier. The most cost-effective. Tell us, from your observations, what would be the three most cost-effective things we could do to tighten this net? Mr. Nelson. As an economist, I'd tell you, first, you would have to tell me how you value safety. If you put a high value on safety, the system that we heard about that the Japanese employ appears to be a far safer system than we have, because they actually have government inspectors going to a limited number of plants who produce food for the Japanese market. So those plants are not only part of this Chinese certification system, they are also part of a Japanese inspection system. And then Japan, on top of that, does 15 percent laboratory testing of the imports. That is a pretty expensive proposition both in terms of the government resources involved in Japan and in terms of the prices of these products in China. One of the real problems with toys or food or anything else in China is the incessant downward pressure to get cheaper and cheaper and cheaper. And we are dealing with entities, people that are living at the margin. That means that niceties, like the downside safety effects of what they do, get less and less important. And what the Japanese system does is--as far as I can tell--as it has been described to me--is create some pretty valuable franchises, franchises whose prices can't be depressed. So there is a price effect to that. There is a price premium and food is more expensive, I understand, in Japan than it is here. And they get a lot of it from China. Mr. Inslee. Thank you. Mr. Stupak. Thank you, Mr. Inslee. Mr. Waxman for questions, please. Mr. Waxman. Thank you, Mr. Chairman. Mr. Nelson, does China treat the food that is going to be consumed domestically differently than the food that is going to be exported? Mr. Nelson. That is what we are told. Mr. Waxman. What do they do differently for the exported food? Mr. Nelson. For the exported food, they tell us they inspect every lot, that they largely come from HACCP-controlled plants, which means there is an ongoing testing program at various stages of the production process, and that they sample every lot and test it in a government lab to both Chinese standards and the standards of the country to which it is to be sent. And certainly that is not done for the domestic food. Mr. Waxman. This is what they tell you they are doing for the exported food. Do you believe it? Mr. Nelson. We couldn't find anyone that thinks that that practice is universal throughout China. But I think that the Chinese Government certainly wants that system. The AQSIQ wants that system to function well. Mr. Waxman. They want it to function well. But you cannot testify to us that it is functioning well? Mr. Nelson. That is right. All of this is done at the local level and the quality of the local officialdom, we are told, varies widely. Mr. Waxman. I'm really stunned by the amount of imports that we are taking into the United States. In 2005, 84 percent of all fish and shellfish consumed in the United States was imported; 54 percent of all tree nuts, 43 percent of all noncitrus fresh fruit, 37 percent of all processed fruit in the U.S. were imported in the same year. That is not just from China; that is from other countries as well. Is China better or worse than some of these other countries where we are importing food? Mr. Nelson. We haven't been to other countries, but to the extent that you can rely on FDA's very small sample, China is in the top three. Virtually all categories for rejected food. But it is not the top one. We reject more food from India. We reject more food from Mexico. Mr. Waxman. We have to rely on our Food and Drug Administration here in the United States when it comes to these agricultural products, including fish. One of the proposed alternatives that we have pending in the Congress is to have the FDA see whether a country has a certification process that would indicate that it is checking the safety of the food that might be imported. And it appears that China claims that they have such a system, but it doesn't sound like one we can rely on. Is that where you come down on that issue? Mr. Nelson. From the evaluation of the investigation we have done today, yes. But a certification system, an evaluation of equivalence, anything like that would require far more work than we have done. The legislation that we are considering in the committee not only requires a certification for the country's evaluation of the safety, but if that is not adequate enough, then the Food and Drug Administration could go to each individual farm. Is that what it would be? Or a processing plant? What would we then do if the country didn't meet the standards? Mr. Nelson. Without commenting on the legislation per se, which is not our assignment, we would need a lot more people if we were going to adopt a Japanese-like system of going over and inspecting every plant that was going to be shipping food to the United States from China. And that is just China. I mean, there is still the Dominican Republic, there is still India, there is still Mexico. Mr. Waxman. So, when we hear about 15 percent of all food consumed in the United States is imported, the American consumers assume that they are taking on the risk because we are not confident that the food that is brought into the United States is safe? Mr. Nelson. Consumers are taking that risk. They also take risks with food that is produced here. Almost all of the really, truly serious outbreaks last year, that you experienced in 2007, has come from domestically produced food. Now, part of that is great good fortune, and the good fortune was that wheat gluten was intended for pet food and not human food. If it had been put in the human food supply, I don't think the statistics would be the same. Mr. Waxman. Thank you, Mr. Chairman. Mr. Stupak. Mr. Melancon for questions, please. You have some extra time also. Mr. Melancon. Thank you, Mr. Chairman. I appreciate the time. And I come from an agriculture background. And one of the things I have attested to on all of these free trade agreements is that we have taken away the authority of the Congress to govern or oversee the commerce in this country. And now it has taken us to have hearings about food safety, when we had the safest food supply in the whole world until the time we started giving away that entity, I guess, to foreign producers. I have a lot of seafood in my district, as you are quite aware. I believe in country of origin labeling. It is as complicated as putting produced or grown and produced in whatever country or State it was, and bottled and shipped from whatever State it is, and those computers do that quite easily these days. So I don't think it is such a complicated task to ask for that. On seafood, does Hong Kong allow seafood from China with any evidence or traces of antibiotics into their country? Mr. Nelson. No. And they also very much limit the ports of entry. And they take one added step. Hong Kong is China. I mean, the stuff is coming down from the Pearl River. So they limit the imports to two piers, and they have gone to a system where not only does the stuff have to be certified at the fish farm, but they put a net over the hold and physically seal it, like you would seal a container in order to prevent bad fish from being substituted for good fish along the way. The mainland Chinese--the PRC and the Hong Kong Government are very, very sensitive to the quality of food that is imported into the administrative district. Mr. Melancon. It kind of sounds like the piece of drum I had the other night that was called Chilean sea bass. And there is a distinct difference between the two. But I guess they figure that most people wouldn't know. When the farm-raised fish, the farm-raised shrimp, the produce that comes into the United States from China--or from any other country for that matter--we have a limited--well, we have an enormous number of ports, as I appreciate it, that will accept imports, whether it is agency-tested, or take samples or not. How many do we have in this country for food or seafood imports? Do you know? Mr. Nelson. Well, there are 321, as we understand it. Customs mans 321 ports of entry. Mr. Melancon. And I understand in Europe they will send back, or not allow into the country, food that doesn't meet their standards. They have limited, I believe, the number of ports that foodstuffs can come through in the European Union. Mr. Nelson. I don't know. Mr. Melancon. Do you know how many ports they may have for importation into the European Union. Mr. Nelson. No. Mr. Melancon. I'm trying to get an analogy for myself, because we have in the United States the importers all up in arms because you want to constrain where you bring your foodstuff in, which they all want to bring it in wherever they want to bring it in. Those that don't want to abide by the rule, obviously because they are not going to get tested, and they will get it in. I saw a copy of an ad for a firm that was advertising, ``If you have been rejected by FDA, get in touch with us; we can help you market your seafood.'' Is that a repackaged resell, or is that they are going to send it to another country? Mr. Nelson. Well, it could be they are a laboratory that is going to assure the importer gets the kind of results that will get through the FDA system. Back in June, the FDA issued an import alert. And that import alert covered five varieties of fish, one of which is shrimp; so four varieties, and shrimp from China for antibiotic and possible fungicide, malachite green contamination. Now, the Chinese, when we were over there, kept telling us that this was awful, that it was going to cost them $500 million because we were banning the import of fish. And I don't think they had any appreciation of how lax the regulations regarding import alerts are, and we had to explain to them that nothing was being banned. In fact, the fish were going to exactly the same place, that they would go through without an import alert. That is to say, they were going to be delivered to the importer's premises, at which point the importer is required to have the fish in this case tested to see whether or not it is contaminated with antibiotics or malachite green. And any source from China, not the country but the processing plant, the entity that is exporting, if they pass muster on these private lab tests five times, then they are off the import alert and can bypass the requirement of private laboratory testing. But we have become very, very skeptical about laboratory testing for a lot of reasons--private laboratory testing for a lot of reasons, and our skepticism is growing. Mr. Melancon. It wouldn't have anything to do with you get what you request when you pay? Mr. Nelson. We have heard there are laboratories that don't find products--fish, produce, whatever they are testing--ever to be out of compliance. And then we find other laboratories that do something we would never allowed in the drug area. If a drug company did was a clinical study, the efficacy didn't show up, or the safety problems developed and they told the people doing the study to throw it away, they would be in very serious trouble, both the clinicians that were doing the study and the sponsoring company. But apparently there is no real penalty, and it is in fact, we are told, a practice within the food system that if a private laboratory gets a result that the importer doesn't like, that they work not for the FDA--in fact, they were not inspected or certified or in any way controlled by the FDA-- they have nothing on the line. The FDA can't even ban them from being used by these importers. They work for the importer, and if the importer tells them to put the test results in a dust bin and just send them a bill, that is very common practice. Mr. Melancon. Do we in this country have the ability to get away from the contractors' lists and utilize universities, would that give us more credibility in the results? If, in fact, we are not able to stand up enough labs because of the cost, are there enough universities that could take samples and do the work for us, and do you think the integrity of the tests would be pretty upstanding? Mr. Nelson. We do use universities in what is called the FERN system, and the FDA does contract with universities to do some of the testing now. And those universities are qualified, the ones that are in the system, to do testing of--particularly involved in---- Mr. Melancon. Is there a standard regimen of tests they are required to make when they are a contractor? Mr. Nelson. FDA witnesses are coming up. I'd suggest if you want the specific details you talk to them about it. We do use universities, though. Mr. Melancon. One more question. Does Hong Kong use private contractors or is that state-run? Mr. Nelson. No. That is all government labs. They, of course, don't have to maintain all the other governmental expenses that we do. Mr. Melancon. Thank you, sir. Mr. Stupak. Thank you, Mr. Melancon. Mr. Green for questions. Mr. Green. Thank you, Mr. Chairman. First I'd like to thank our investigators for spending part of their August in China. Having been there once, but having both family and friends who have gone there to spend a lot more time in doing work like what you do, it is probably not as pleasant as what we did in just meeting with officials. One of the interests I have is comparing what, for example, Hong Kong and Japan is doing with--Hong Kong actually has a vigorous inspection system, whereas Japan actually has the preferred importers, so to speak, I guess they investigate what they do in China, for example. Does the Japanese, though, have a food inspector at every port of entry that brings in food or is authorized to bring food in? Mr. Nelson. That is my understanding. We are very fortunate, in the next panel, of having people with a lot of expertise on Hong Kong and Japanese and Chinese regulatory systems. Mr. Green. One of the interests I have, though, is I note for example, the testimony we will hear in a few minutes is that FDA has inspectors at 90 ports now, and USDA has it at 140 ports, both land and ocean, and yet FDA has 80 percent of the responsibilities as compared to the USDA which has 20 percent. I would assume that the countries that you looked at would have that percentage reversed; you would actually have more inspectors for the food that the FDA would do under ours as compared to the Department of Agriculture. But anyway, that is just a question, and I will wait until our next panel. You mentioned the Chinese efforts to strengthen the safety of imports through what's called a red list and a black list. And can you talk about the effectiveness of that red list and black list in rooting out some of the bad actors? Was that part of your investigation? Mr. Nelson. We talked with the AQSIQ about the systems. They listed it as one of five essential parts of their program for guaranteeing the safety of the food exports. They told us that there were 55 firms on the black list, which, given the press reports of what happens to people when the Government of China is truly upset with them, is a list I wouldn't want to be on. It was not clear what the preferential treatment for the good actors was. Mr. Green. Another question is the export certificates are certificates granted at the local level? And the political situation I know varies from province to province and there has always been a geopolitical question about how much the central government controls in some of the provinces as compared to the local officials. Can you speak to any of the concerns about corruption? Is there any particular--that the Federal Government may not actually have the apparatus to make sure those export certificates are valid when they are issued by the local government. Mr. Nelson. Except for the power to yank a firm's ability to acquire an export certificate, all of the decisions are made on a local level. I mean, if a firm gets caught exporting something out of spec, then the Beijing Government will yank their authority to export until the problem is solved. But they don't do any of the inspections, they don't control any of the budgets. The rubber meets the road at the local level, and we are told that that varies widely. Some provinces like Guangdong have apparently very effective CIQ systems. The province that is immediately across the sea from Japan that sends a lot of the produce on a just-in-time basis to Japan apparently has a fairly good regulatory system, but other provinces may not. Mr. Green. Mr. Chairman, one last question, I guess, is that if produce is exported to Hong Kong, it is rigorously inspected, is there any transshipment of that produce? Could Hong Kong, because of their rigorous system, be someplace that would be a preferred export port, for example, because of their effort as compared to the other ports in China? Mr. Nelson. I don't think Hong Kong exports food. They import 95 percent of the food they consume. And almost all of that is from China. I mean, you can get French wine, you can get some form of Iowa beefsteaks without the bone. But they are not a food exporter. Mr. Green. Thank you, Mr. Chairman. Mr. Stupak. Thank you, Mr. Green. If anyone else has questions, we will just do another quick round here. You mentioned a couple of times the AQSIQ. That stands for the Administration of Quality, Supervision, Inspection and Quarantine? Mr. Nelson. Yes. Mr. Stupak. Mr. Barstow, when you met with Chinese officials, what was their opinion about the concerns Americans have concerning the quality and safety of Chinese food? Mr. Barstow. The AQSIQ said they had been studying the concerns that Americans have, and the exported food problems are perceived to come from China. And they came up with three conclusions. The first conclusion was that there are some real safety and quality problems in China. The example they cited for this conclusion was the melamine in wheat gluten. They said when this kind of problem happens, they are dealt with according to law and regulations. In the melamine case, they said that they shut down the factories as soon as they learned about it and that they filed suit against the two companies that were responsible. Mr. Stupak. Did you ask why they wouldn't let the FDA inspectors in to check these melamine plants? Mr. Barstow. That is another issue. Second, they said that there are different international standards that create problems. In this conclusion, they cited the toothpaste example. Earlier this year, toothpaste from China was found to contain diethylene glycol, or DEG. In China, it is permitted to be present in up to 15.6 percent of toothpaste there, and international standards said that DEG could not be in any toothpaste. China said that there were no real safety problems with DEG in toothpaste but they succumbed to international pressures and now banned its use. However, that still doesn't explain why the DEG was listed as glycerin, which is the harmless ingredient that it replaces. Third, they said that they believed the Western media, particularly the media in the United States, has blown the safety and quality problems out of proportion. They believe press reports have been unfair. Mr. Stupak. Thank you. Mr. Nelson, at the last food safety hearing, we spoke about the FDA food import alerts, specifically import alerts that contained the instruction, ``detention without physical examination.'' Remind us again, what does that mean, ``detention without physical examination''? Mr. Nelson. I think all import alerts contain that. It means that the product goes to the importer's premises. And before it can be released into the commerce of the United States, the importer has an obligation to prove to the agency that it is nonviolative. That is done by the importer contracting with a lab to test it. Mr. Stupak. So the FDA doesn't take control of it. They don't send their inspectors in. The processor or the importer has the food, and then he hires a private lab to test the product? Mr. Nelson. That is overwhelmingly the case. Mr. Stupak. At the last hearing you spoke about port shopping and how some importers choose to shift their products to places without FDA inspectors or labs, and how some importers try to get around the import alerts. Have you learned of schemes being used? Mr. Nelson. The one that was most disturbing was in talking to people about private labs. An issue arose as to whether not only--foods under import alert, but the surveillance testing that the FDA does, the more randomized testing of imports coming into the United States, there was a proposal that that be contracted out to private labs. So we have been talking to people in private laboratories. And the most shocking thing that we have learned is that there is no apparent ethic within the community nor is there any regulatory concern about taking negative results, results that would indicate the food is contaminated or decomposed or otherwise unfit for human consumption, and just discarding them if the importer gives them that instruction. Mr. Stupak. If the Chinese Government says they certify their labs and they certify these farms and things like this, does the FDA certify the labs that the importers use to check the results or for suspicious---- Mr. Nelson. Neither the FDA or any other governmental agency. Mr. Stupak. So these labs are unregulated. They work for the importer and basically they get the results that they pay for? Mr. Nelson. Right. The FDA does audit. I doubt whether it is significant. We have asked them what percentage. I suspect it is very small. But the audits are largely an audit of the paper. It is not an audit of the lab or its capacities to produce the results that they claim to produce. Mr. Stupak. You mentioned on drugs it does not occur. Are those labs certified by the FDA for drug imports? Mr. Nelson. Those labs--well, actually not necessarily. University labs certainly are well supervised, and some of the other labs that are used by drug companies for testing are not anything more than doctors' offices, and some of them are even done overseas now. But if a drug company gets caught cheating, the FDA treats it as a criminal offense with serious consequences for the individuals involved. Mr. Stupak. What happens if a food importer gets caught cheating at these labs? Mr. Nelson. Nobody asks whether the food importer cheats or not. Mr. Stupak. So no one inquires? Mr. Nelson. No. Mr. Stupak. And, of course, your teams work on food safety issues. I brought up last time other areas of concern, particularly when we uncovered evidence of questionable compensation at the FDA. Have you uncovered other questionable practices? Mr. Nelson. One of the practices which is detailed in-- well, the FDA information was received so far from--it has been placed in the exhibit book and presumably into this record, as well as into the record of the last hearing. Mr. Stupak. Tab No. 35. Mr. Nelson. Yes. It involves the abuse of the concept of religious compensation, a concept where people are allowed to work some overtime, so that they can take a religious holiday every now and then, without taking vacation time. This has been grossly abused in some cases. Mr. Stupak. All right. I mentioned that we're going to have a hearing on November 1 on drug imports, and November 13 on domestic food again. You and your team will continue to work on these issues, plus compensation issues at the FDA; is that correct? Mr. Nelson. That is our instruction. Mr. Stupak. Thank you and thank you for your investigation. Mr. Whitfield, any questions? Mr. Green any questions? Mr. Melancon. Mr. Melancon. I am back on seafood. Does China allow a high concentration of antibiotics in their seafood domestically than we do in the U.S.? Mr. Nelson. Certainly more than we do. I don't know whether it would be considered high. But we don't permit it. Mr. Melancon. But we don't permit it, but we don't check it? Mr. Nelson. We haven't been doing a very good job of it. The FDA has known about this problem since 2000, 2001. But they didn't act on a countrywide basis until June 2006, about a month after the first letter came from the subcommittee requesting information about their regulation of seafood imports. Mr. Melancon. And we talked about shipping products and the problem of different countries, different regulations and guidelines and whatever. Don't you think it could be done, particularly in these trade agreements on a WTO level, if we are going to do it on a level playing field, that we have a minimum requirement for all countries, and then each country has its own specific requirements that these things can be adjusted or adhered to if these countries want to export their products to countries that have higher standards? Mr. Nelson. They're supposed to meet our standards for entry and they are supposed be denied entry if they don't meet our standards. That's the law. Mr. Melancon. But there are no teeth there to get them if they don't? Mr. Nelson. We don't have the resources to do the inspections and the testing that we need to assure that the problem is under control. Mr. Melancon. Thank you. Thank you, Mr. Chairman. Mr. Stupak. Mr. Burgess, we have been going around with last-minute questions of this panel before we excuse them. Do you have any further questions of this panel. Mr. Burgess. Yes, Mr. Chairman. Thank you. For a point of clarification, Mr. Nelson, when you talked about the FDA testing only a fraction of what they inspect, you made the statement they don't test enough and that there was no confidence in their statistical standards. Did I understand that correctly? Mr. Nelson. Yes, sir. Mr. Burgess. I'm not a statistician and I'm not really a student of statistics. But from the very brief and unfortunate association I had with the study of statistics in college and graduate school, I recall that there were some scientific tests and some scientific standards by which you could assure yourself or--you didn't just pick a sample size out of the air. There were actually formulas that could be followed to arrive at a statistical number over which you'd have a certain degree of confidence. So are you telling us that the principles of statistics are not being applied in the metrics that are used in our inspection facilities? Mr. Nelson. Not only are the principles of statistics not being applied, we have seriously degraded the percentage of imports that we have tested for the last two decades. Mr. Burgess. But there should be someone--not up here on this dais--but someone who knows statistics, who is able to advise our FDA on what is the sample size you should be testing and what are the confidence limits that you can then project from that sample size you've tested. Is that not correct? Mr. Nelson. Theoretically. Mr. Burgess. In your observation, were those statistical methods not applied? Mr. Nelson. The sample size is so small relative to the size of the imports that I think probably you can't generalize across all food imports. Mr. Burgess. But we shouldn't have to intuit whether a sample size is too small, just right, or too large. Someone, presumably, who knows the science of statistics, should be able to tell us this is the sample size that should be tested if you want these confidence limits on the results that you are seeking. Mr. Nelson. I have seen that for drug safety, actually. There have been some articles in journals published in the last year on drug safety as a whole in the United States. I have never seen it done for food. Mr. Burgess. But again, presumably, the science of statistics has developed enough where someone would have this information and be able to share it with us. Mr. Nelson. Quantitative risk assessment is possible. The data isn't there. Mr. Burgess. Well, whether the data is there or not from the FDA standpoint, someone should be able to tell us if we are doing not enough, if we are doing just right, or if we are doing too much, as you may think in Hong Kong. Someone should be able to rationally tell us what the sample size is we should be testing. We shouldn't, again, be making that up as legislators. We shouldn't be asked to make that up on the basis of emotion, this looks right, this looks too small. Someone should be able to tell us scientifically what the number is. That would be my estimation. Thank you, Mr. Chairman. I will yield back. Mr. Stupak. Thank you, Mr. Burgess. With no further questions, we'll excuse this panel. Thank you, gentlemen, for your work. And I will call our second panel of witnesses to come forward. On our second panel we have Dr. Michael Martin, who is an analyst in Asian political economy at the Congressional Research Service. Mr. James Rice is vice president and country manager for Tyson Foods in China. 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 gentlemen wish to be represented by counsel at this time? Let the record reflect that both witnesses indicate that they do not. [Witnesses sworn.] Mr. Melancon [presiding]. Let the record reflect the witnesses replied in the affirmative. You are now under oath. Dr. Martin, would you like to start with the opening statement for 5 minutes? STATEMENT OF MICHAEL F. MARTIN, ANALYST, ASIAN TRADE AND FINANCE, FOREIGN AFFAIRS, DEFENSE, AND TRADE DIVISION, CONGRESSIONAL RESEARCH SERVICE, LIBRARY OF CONGRESS Mr. Martin. Chairman Stupak, Ranking Member Whitfield, distinguished members of the subcommittee, thank you for the opportunity to appear before you today. With your permission I would like to submit my statement for the record and provide you with a brief summary of its contents. You have asked me to testify on how Hong Kong and Japan ensure the safety of their food imports from mainland China. While concern about the safety of food imported from China has arisen in the United States in 2007, this issue has been important to Hong Kong and Japan for a number of years. In December 1997, Hong Kong slaughtered over 1.5 million chickens to combat an outbreak of avian flu that claimed the lives of six people. Virtually all those chickens had been imported from China. In July 2002, Japan banned the import of frozen spinach from China after several shipments were found to contained an unacceptable level of pesticides. Prior to the ban, China had supplied Japan with 99 percent of its imported spinach. As a result, the Hong Kong Government has been aware of the issue for at least 10 years and the Japanese Government has been aware of it for at least 5 years. Food imports from China are of particular concern to the Hong Kong and Japanese Governments because China's an important source of food. China supplies Hong Kong with about 80 percent of its food and Japan with more than 10 percent of its food, second only to the United States. Under Hong Kong law, the primary responsibility to ensure the safety of all food imported or domestically produced is placed in the Hong Kong Food and Environmental Hygiene Department in its recently established Centre for Food Safety. In 2006, the Centre for Food Safety was given specific responsibility for planning and implementing Hong Kong's food safety policies, negotiating and managing relations with overseas food authorities, including China, and consulting with the businesses and people of Hong Kong about its food safety system. Over the last 10 years Hong Kong's Food and Environmental Hygiene Department and its mainland China counterpart have agreed to a set of administrative procedures to ensure the safety of food shipped to Hong Kong. These special procedures include joint visits to farms and food production facilities in China, technical exchanges and frequent meetings to discuss food safety issues. In order to expedite inspection, Hong Kong limits the number of points of entry for imported food. Failure to comply with Hong Kong's laws and regulations governing the imported food is punishable by up to 6 months in jail and a maximum fine of about 50,000 Hong Kong dollars, or about 6,400 U.S. dollars. In 2006, the Centre for Food Safety took over 64,000 samples for microbiological and chemical testing. The overall failure rate was 0.3 percent. However, in its latest report, which covers from July until August 2007, the center found a slightly higher failure rate of 0.6 percent. Neither report indicated what percentage of the imports were tested. Turning to Japan, the Food Safety Basic Law disseminates the enforcement of food safety throughout Japan's federal, provincial and local governments. In general terms, the federal agencies handle food safety enforcement for imported goods and the provincial and local governments focus their efforts on domestic enforcement issues. The Food Safety Basic Law also created the Food Safety Commission, a cabinet-level independent agency that overseas the government's activities on food safety. Food imported into Japan is subject to inspection by roughly 300 inspectors located at 300 quarantine stations. Inspections cover over 300 food products, nearly 800 agriculture chemicals and include nearly 55,000 inspection criteria. Between April and September 2006 the ministry inspected 10.3 percent of the shipments, 0.7 percent were found to be in violation of Japanese law. The most recent amendment to Japan's food sanitation law raised the highest penalty for violation of the law to up to 3 years in jail or a fine of up to 3 million yen, approximately 26,000 U.S. dollars. Relations between Japan and China on the issue of food safety take place in two separate arenas, government-to- government relations and company-to-company relations. On the government-to-government side, Japan has negotiated over 30 separate agreements with China, specifying equivalency standards for the range of food items. Under these agreements, Chinese health officials certify that specific farms and food production facilities meet the agreed standards. In Japan, food shipments from these certified Chinese farms and facilities are afforded preferential treatment to imports from noncertified farms and facilities. As a result, on the business-to-business side, Japanese importers tend to source their food products from the certified farms and facilities, often offering a higher price for the goods in order to lower the risk of shipments being inspected or impounded. Based on the preceding summary as well as my written testimony, I would like to offer four somewhat interrelated observations. First, collaboration generally has been used more than confrontation. Part of the overall strategy of Hong Kong and Japanese food safety officials when dealing with their mainland Chinese counterparts seems to be focusing on the shared issue of protecting people from unsafe and unsanitary food. Second, the carrot has been used more often than the stick. In their dealings with Japanese officials and businesses, both Hong Kong and Japan appear to have adopted an approach of providing incentives for the Chinese Government to cooperate rather than penalizing failures to comply. Third, food safety is not simply a matter of laws and regulations. Another element of the Hong Kong and Japanese approach to food product safety is the apparent focus on creating incentives for businesses to comply with the laws and regulations. Both Hong Kong and Japan seek to create an environment in which it's in the best interest of the Chinese food producers and exporters as well as the Hong Kong and Japanese food importers to make sure that the imported food are safe and sanitary. Fourth, no system is perfect. No matter how well designed the policy or how well the policy is implemented, it is impossible to guarantee that every morsel of imported food, whether it's from mainland China or some other location, is 100 percent safe and sanitary. The Hong Kong and Japanese Governments have food safety policies in place but they both continue to experience problems with tainted and unsafe imported food products. Chairman Stupak, Ranking Member Whitfield, distinguished members of the subcommittee, this concludes my statement. Thank you again for the opportunity to testify on these issues. I will be pleased to respond to any questions you might have. [The prepared statement of Mr. Martin follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Melancon. Thank you, Dr. Martin. We appreciate your testimony. And I will wait for questioning. Mr. Rice, you have a 5-minute opening statement if you would, and if you have anything longer, if you would like to submit it. STATEMENT OF JAMES M. RICE, VICE PRESIDENT AND COUNTRY MANAGER, TYSON FOODS, INC. Mr. Rice. Thank you. My name is James Rice, and I am vice president of Tyson Foods, Inc. I also served on the Board of Governors of the American Chamber of Commerce in Shanghai. I've worked with Tyson for the last 3\1/2\ years, but my involvement in China began 20 years ago when I was an exchange student from the University of California in 1987. In 1991, I returned to China and have worked and lived there continuously until now. Tyson Foods has a significant export business from the United States to China. Of the U.S. poultry industry's $500 million in exports to China this year, Tyson's share will be approximately $200 million, and our business is growing at 25 percent a year. China is now the largest destination of U.S. poultry exports, and the largest U.S. exporter to China by dollar value is poultry. Tyson also exports cattle hides and pork from the U.S. to China. In China, Tyson produces meat and poultry products for both domestic and export consumption through two joint venture operations. We maintain relationships with Chinese poultry companies who produce products on our behalf for global customers in Japan and in Hong Kong. So I hope to draw from this experience to share with you some insights on China's quality management processes. Despite wide news coverage, China does have modern food producers who are able to produce quality products for domestic and for export consumption. China's General Administration of Quality Supervision, Inspection and Quarantine, commonly known as the AQSIQ, has processes that ensure quality food products are exported. The evidence on the ground from what I have seen indicates that modern manufacturers and the AQSIQ can do their jobs, and their processes are improving. China has a vital interest in improving its food safety programs for many reasons, and the country is learning that national food safety assurance systems require time, resources and flexibility to accommodate industrial technological changes. For example, the AQSIQ is now developing a food recall system, improving labor requirements and also a traceability system. Another example is China's Export Food Safety Program, which requires that all export food must originate from an AQSIQ-registered plant and be certified by a local China inspection and quarantine agency, which is the local version of AQSIQ. The AQSIQ only authorizes 12,700 of the country's 450,000 food producing companies to export. This list is expanded and shortened by the AQSIQ based on the performance of companies, just like the USDA maintains a list of authorized meat and poultry exporters in the United States. The way it works is that Chinese food processors are certified to export. They will notify the AQSIQ when they are going to produce for export, and the AQSIQ or CIQ inspectors will be present during the process. These inspectors will evaluate the suppliers, the raw materials, the production process and the finished products. Only after this process will they issue a certificate for export. It is my understanding that for the most part food safety issues we have heard about in the United States have come from companies other than those authorized by the AQSIQ. Chinese poultry exports to Japan have an additional level of quality assurance. The AQSIQ has selected 35 of the best poultry producers in China to be eligible to export to Japan. Then Japanese Ministry of Agriculture, Forestry and Fisheries, the MAFF, visited and certified these plants. They are inspected annually by Japan's MAFF, but it's the AQSIQ that has responsibility to ensure these 35 plants meet compliance with both the Japanese import regulations and also the Chinese export regulations. Today these plants operate at a higher level than do their competitors, not only because the Japanese customers require it but because the responsibility for food quality and safety is shared equally and completely between the manufacturer, the AQSIQ and the Japanese MAFF. When Tyson manufactures products in China, both for domestic and for export consumption, we use only these Japanese certified suppliers, ensuring that we start with the best suppliers. These suppliers and their suppliers are audited regularly by our American quality assurance manager and we practice at our facility 100 percent inspection of all incoming raw materials. When Tyson products are manufactured by our partners, our quality assurance manager and our American plant manager are in those facilities to ensure the same quality standards are maintained. Our global customers also audit our plants and our suppliers, and the net result is that regulators, the manufacturer, and the customers are working together to ensure the quality of our products. As a brand owner, our job is to be certain that all levels of private and public sector quality assurance work together to identify, manage and mitigate all food safety risks. In this way, regulators, brand owners share food safety responsibility with foreign regulators and manufacturers. Not that the responsibility is divided but that every entity shares 100 percent responsibility to be sure the product is right before it leaves the Chinese plant. There's no question that China plays an enormous role in the global economy as both an importer and an exporter of foods and many other products, but we need to consider how to work with China and make sure that relationship is mutually beneficial. The end result is that both countries can implement the same quality standards and sell the same high-quality products to both countries. Thank you. [The prepared statement of Mr. Rice follows:] Testimony of James M. Rice My name is James Rice and I am vice president of Tyson Foods, Inc. and Country Manager for Tyson's China Operations. I also serve on the Board of Governors of the American Chamber of Commerce in Shanghai. I have worked with Tyson for the last three and a half years. My involvement with China began 20 years ago when I was an exchange student from the University of California in 1987. I returned to work in China in 1991 and have lived and worked continuously in China ever since. Tyson Foods, Inc. has a significant export business from the U.S. to China. Of the U.S. poultry industry's $500 million in exports to China this year, Tyson's share will be approximately $200 million and our business continues to grow at a rate of more than 25 percent a year. China is now the largest destination for U.S. poultry exports. And the largest U.S. export to China, by dollar value, is poultry. Tyson also exports cattle hides and pork from the U.S. to China. Tyson also produces meat and poultry products in China for both domestic and export consumption through two joint venture food processing facilities. We maintain relationships with local Chinese poultry companies who produce products on our behalf for global customers in Japan and Hong Kong. I hope to draw from this array of experience to share with you some insights on China's quality management processes. Despite wide news coverage of its challenges, China does have modern food producers who are able to produce quality products for domestic and export consumers. China's General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) has processes that ensure quality food products are exported. The evidence on the ground indicates that the modern manufacturers and the AQSIQ can do their jobs, and they are rapidly improving their processes. China has a vital interest in improving its food safety programs for many reasons, and the country is learning that national food safety assurance systems require time, resources and flexibility to accommodate industrial and technological changes--as well as shifting global demands. For example, the AQSIQ, from what I understand, is developing a food recall system, improved labeling requirements and a product traceability system. Another example is China's export food safety program, which requires that all exported food must originate from AQSIQ-registered plants and be certified by the local China Inspection and Quarantine agency, or CIQ. From what I understand, AQSIQ only authorizes 12,700 of the country's 450,000 food companies to produce for export. This list is expanded and shortened by the AQSIQ based on the performance of the companies, just like the USDA maintains a list of authorized meat and poultry exporters in the US. The way it works is that Chinese food processors certified to export will notify the AQSIQ when they are producing for export, and AQSIQ inspectors will be present during the process. They will evaluate the suppliers, raw materials, production processes and finished products. Only after this will a Certificate for Export be issued. It is my understanding that for the most part, food safety issues we have heard about have come from companies other than those authorized by the AQSIQ. Chinese poultry exports for Japan have an additional level of quality assurance. The AQSIQ selected the 35 best poultry producers for eligibility to export to Japan. Then, Japan's Ministry of Agriculture, Forestry, and Fisheries (MAFF) visited and certified these plants. They are inspected annually by Japan's MAFF, but it is China's AQSIQ that is responsible for ensuring these 35 plants' continuous compliance with both the Japanese import standards and the Chinese export standards. Today, these plants operate at a higher quality level than do their competitors not only because their Japanese customers demand it, but because the responsibility for food quality and safety is shared equally and completely by the manufacturer, the AQSIQ and the Japanese MAFF. When Tyson manufactures products in China--for both domestic and export consumption--we use only suppliers that are already certified for Japanese export, ensuring that we start with the best suppliers. These suppliers, and their suppliers, are audited regularly by our American quality assurance manager, and we practice 100 percent inspection on all raw materials coming into our facility. When Tyson products are manufactured by our partners, our quality assurance manager and our American production manager are in those facilities ensuring that the same quality standards are maintained. Our global customers also audit our plants and our suppliers. The net result is that regulators, the manufacturer, and customers are working together to ensure the quality of our products. As the brand owner, our job is to be certain that all levels of private and public sector quality assurance work together to identify, manage and mitigate all food safety risks. In this way, U.S. regulators and brand owners share food safety responsibilities with foreign regulators and manufacturers. Not that the responsibility is divided, but that each entity shares 100 percent responsibility to be sure the product is right before it leaves the Chinese plant for the United States. There is no question: China plays an enormous role in the global economy as both an importer and exporter of foods and many other products. We need to consider how we work with China to be sure our relationship is mutually beneficial. The end result will be that both countries can implement the same quality standards, and guarantee that high quality products could be sold to consumers in both countries. ---------- Mr. Melancon. Thank you, Mr. Rice. Appreciate your testimony. Mr. Green, would you like to entertain some questions? Mr. Green. Thank you, Mr. Chairman. Mr. Rice, in your testimony, you stated that Tyson manufactures products in China and uses only suppliers that are already certified for Japanese export. Do you pay a premium for that? Mr. Rice. Yes. The purchasing of raw meat from a Japanese certified supplier will cost us about 20 to 30 percent more than any other uncertified poultry company. Mr. Green. I know there are lots of other companies that import from China. Do you know any of the other companies that make that determination to only use the Japanese export certification? Mr. Rice. No, I don't. It's our policy because we want to start with the higher quality. I don't know about the other guys. Mr. Green. You state that 35 poultry producers are eligible to export to Japan, these producers selected by China's AQSIQ. Do you know how many of these 35 plants actually export to Japan? Mr. Rice. All 35 of them. Mr. Green. All 35 are eligible. How many actually do? Mr. Rice. All 35 plants actually export to Japan. Mr. Green. I'd like to ask about the quality control in China. Is it possible to use manufacturing processes with application of Western standards in Chinese production? Mr. Rice. Yes. For our plant, and I'm sure for many American companies, we use the same processes that we use in the United States. Mr. Green. And is it possible to use the same quality internal mechanisms that are here in the United States? Mr. Rice. Yes. Mr. Green. Is it possible to use the same HACCP programs in China? Mr. Rice. Yes. Our plant uses this. Mr. Green. Can you explain the importance of producers using those HACCP programs? Mr. Rice. Can I explain the what? I didn't understand the question. Mr. Green. The importance of the producers using those programs. Mr. Rice. Well like I say, it works for us. It's a proven process. It's one of many quality control tools that you can use in your plant. And for Tyson, we use it in all of our facilities. So it's very successful for us. Mr. Green. Since you're on the Board of Governors, American Chamber of Commerce in Shanghai and you have contact with other counterparts, I would assume, and do other firms in China operate--American firms use that same quality control practices? Or I know you said earlier your competitors, you don't know what they do. But you know what you do. Do you know of any other companies that, for example, just in talking with your other members of the Chamber? Mr. Rice. Yes. I believe that most of my counterparts are using the same quality standards. And I think that is the case for any consumer products company that's using their brand. And I think you will want to protect your brand by using your same quality standards that you have in the United States. Mr. Green. You told the staff that good manufacturing processes can be summed up in one phrase, inspect what you expect. Mr. Rice. That's right. Mr. Green. And could you elaborate on that? Mr. Rice. That, I was speaking in the context of when you're using third-party plants to manufacture your products. In some cases where we use a copacker. And in this case if you want high quality results, you have to put people on the ground to make sure you do it. When we run products at a facility that we work with that we don't own, in that case I have five quality control people from my plant there to be sure that that's the right product. Mr. Green. And in China--I know, Mr. Chairman, we're talking about food today. But it seems like with the other jurisdiction in our committee, on the toys and with Mattel, it would seem like that would have been a good example for maybe some of our product manufacturers other than food to use that if they inspect what you expect. So it would seem like they would check the paint that they would use on those toys even before they bring them over. Thank you, Mr. Rice. Mr. Rice. Thank you. Mr. Green. I yield back my time, Mr. Chairman. Mr. Melancon. Thank you, Mr. Green. Mr. Burgess, did you have some questions? Mr. Burgess. Yes. Thank you. Dr. Martin, on the issue of the safety record in Hong Kong and Japan, I think you referenced 0.3 failure rate and 0.6 failure rate for each of those countries respectively. Or I may have got that backwards. And I will just preface this by saying any time that you have me up here talking about statistics, it's a bad day for me and whoever I'm talking to. But since this is the subject we're on, and you heard the discussions that I had with the previous panel, I guess my question to you is, at this point from your testimony and your observation, your study of the two systems in Hong Kong and Japan, we can kind of get an idea of how strict they are, but do we really have an idea of how good they are? That is, do we know if they in fact are detecting, and you reference it in your testimony, it's difficult to prove a negative. Do we know that they were only getting the very best products coming in to them because after all, they're Japan and Hong Kong and they're going to look real hard? Or is this the normal stream of products that would go to any importer and this is the failure rate that's discovered from just the native stream of exports? Mr. Martin. The figure 0.3 percent was from Hong Kong for 2006; 0.6 was in 2007, the most recent 2-month period in Hong Kong. In Japan 0.7. As far as I could ascertain, USDA and the FDA do not come out with a comparable figure. And you do have statistical problems in coming up with comparable figures. But I think you're putting your finger on a very important issue, which is when you are looking at a large population, you're taking out a select sample from it, inspecting those and then finding out an incident rate in which they failed to meet whatever your standards are. Are you representative of the population in general? Can you extrapolate from the smaller sample to the larger one? And as you were asking earlier, yes, there are statisticians out there that could give you that information. But then the question becomes, is that the result you want? In other words, if you find out that 0.3 percent of the subpopulation is indeed representative of the overall population, of all the goods coming in you're effectively saying that 0.3 percent of the shipments coming into your country from a location, from an area, from a company, whatever the case may be, are tainted or unsafe. So then the other question gets to, if I understood earlier, what kind of goals do you have for your sampling technique? Last comment on this then is, my sense from the Japanese and Hong Kong system is that because they're using a preferential system of determining which shipments to sample, that they anticipate that the incident rate in the subpopulation, sample population is higher than the overall shipment level. So it sets sort of an upper bound of the theoretical number of unsafe shipments coming into Japan and Hong Kong. Mr. Burgess. So that is a knowable number, or a range of numbers. Mr. Martin. It's a knowable number for that population. Mr. Burgess. For that year? Mr. Martin. For that year and that time. Mr. Burgess. That underscores the complexity of all this. And you heard some of my earlier comments. I guess my frustration sitting here as a Member of Congress ostensibly with oversight over the agencies that are responsible for ensuring the safety of the Nation's food supply is we get recall, recall, recall, product safety violation, product safety violation, product safety violation. We don't have the red button on the conveyor belt that we can hit and stop and then go back and do these statistical analyses to find out where the problem is and how to correct the problem. Right now we're just sort of at the receiving end of all this either spoiled, tainted, food, junk, toys, whatever it is. And even from the standpoint of the toys, although that's not the--what we're dealing with today, you've got to imagine that this conveyor belt dumping all these lead-based toys in our country, what are we going to do with them? And Mattel couldn't really answer the question of what they're going to do with them. With spoiled fish it's a little bit different. But it is still the same point, how can we as legislators--and this is what I'm struggling with and I don't think Chairman Dingell's bill has gone quite the direction I would like to see it go. How do we put that stop button on the conveyor belt and say, don't do this anymore until we figure out what's going on? Mr. Martin. I can't comment on the particular specific legislation before you. But what I could say is in the case of Hong Kong and Japan, what they appear to be using is a tiered approach. They try to, to a certain extent if I may, export the issue of monitoring evaluation certification to the exporting entities, the exporting companies as well, to make sure that the products that are coming in are to a certain extent safe. Then they go through a rigorous inspection procedure, again to make sure at a second step that the products are safe. And then in the case of both Hong Kong and Japan, internal to the country you have inspectors that are going around--there's a recent case in Japan where they pulled some eels off the shelf--and this in my testimony--found out that there was an unsafe level of pesticide in it, and pulled all the fish off the shelf. So the process that seems to be used, the method that's being used in Hong Kong and Japan is, you don't just check once, you check twice, you check three times. And I believe if I may, from the testimony that Mr. Rice is indicating, and also what I tried to indicate in my written testimony, you also have this going on in a parallel process in the private sector. They're checking once, they're checking twice, they're checking three times. Mr. Burgess. That brings us to our next point. Mr. Rice, maybe you can weigh in on this as well. If you find at the endpoint, oh, my gosh, there has been a problem, what is the mechanism that you have or that you need, Dr. Martin, to be able to say stop, let's go back to square one and see where the problem is because we definitely have a problem. And not just continually read about it in the Wall Street Journal or the New York Times over and over and over again. Mr. Rice. Well, in the case of my plan we have traceability. So we keep records of all incoming raw materials and what batches they were made into so we can pull it back. Mr. Burgess. If I may interrupt for a second. You can trace it, but can you stop it once that hits the news wires, once that hits the public consciousness that once again we've got a tainted product coming in from the People's Republic of China? Can you stop it? Mr. Rice. I can't stop the news, but I can stop my product. Mr. Burgess. You can stop your product and go back and investigate why the problem occurred? Mr. Rice. Yes. Mr. Burgess. Why do you suppose we're not seeing that process followed? Why are we not seeing the conveyor belt stopped, the inspections done and the problem solved? Why do we have to keep having the same news stories over and over and over again? Mr. Rice. I don't know. You have to have traceability to some extent so you can trace where your product goes and where it came from. Mr. Stupak. [presiding]. Thank you. Mr. Melancon for questions, please. Mr. Melancon. Thank you, Mr. Chairman. Mr. Rice, does Tyson export from the United States foodstuff? Pork, chicken? Mr. Rice. From the U.S., yes. Mr. Melancon. The standards by which they meet, is it that the use for export from the United States to other countries, is it the same that we use for domestic production and sales? Mr. Rice. Yes. Same plants. Mr. Melancon. The imports to other countries from your plants around the world, are they the same standards as you would do in the United States, say, from China to Hong Kong or to Japan? Mr. Rice. No, they can be different. Mr. Melancon. They can be different. Is there some cost differences that makes some tremendous amount of difference that you couldn't have it uniform across your operations around the world? Mr. Rice. Well, every country is different. So it is hard. We have specific plants in the U.S. whose products might go to China, in other plants it would go to Russia. So we keep them separate. But you couldn't make one product applicable to the whole world. Mr. Melancon. Poultry, are we a net importer or exporter? Mr. Rice. Exporter. Mr. Melancon. And for Japan for poultry? Mr. Rice. Japan is an importer. Mr. Melancon. China? Mr. Rice. China imports from the United States poultry and exports to Japan poultry. Mr. Melancon.So they buy some of our chicken and send it over there. Mr. Rice. From the United States we export mostly chicken paws and wing tips. And China is exporting leg thighs to Japan. Mr. Melancon. I have been to Eastern Market and am still trying to figure out what they do with those chicken paws. Mr. Rice. I have eaten one and I sell the rest. Mr. Melancon. I think I'd grind them all and sell them. I guess what I'm trying to figure out is what complications is there to try and have one standard for a company such as Tyson so that when we know we get product from say Japan or from China coming into this country, poultry product, that it would be the same or the equivalent of what we would ship out of this country or consumed in this country? Is it that complex a problem that it couldn't be standardized to those expectations, because of the nature and the size of your company for instance? Mr. Rice. Well, the best for us would be the USDA equivalent. That's the product we ship out. Mr. Melancon. So USDA basically does keep monitoring pretty well your products? Mr. Rice. Right. Mr. Melancon. But does FDA have any authority or jurisdiction? Or do they monitor or check any of your outgoing or incoming? Mr. Rice. Not that I know of. But I don't work in the United States. Mr. Melancon. But you are glad to be home? Mr. Rice. Yes. Mr. Melancon. Am I'm going looking to see if I have any other questions, Mr. Chairman. Mr. Stupak. Thank you, Mr. Melancon. Mr. Rice, besides poultry, any other products you produce in China? Mr. Rice. We are minority owner of a pork processing plant, but we don't export from there. Mr. Stupak. You indicated you use poultry. You obtain them from Japanese certified farms, right? Mr. Rice. Right. Mr. Stupak. Are there other countries that have certified plants or farms in China, Korea or---- Mr. Rice. Korea has certified plants. Singapore has certified plants, so does Malaysia. And I believe the European Union is working on something. Mr. Stupak. And the U.S. doesn't have any certified plants? Mr. Rice. Not that I know of. Mr. Stupak. Do you use other certified plants then for poultry or just the Japanese ones? Mr. Rice. We use just the Japanese ones. Mr. Stupak. Have you considered using any other country farms there? Mr. Rice. Well, I have. But there's less quality control systems in place in those plants. So I would have a higher risk if I did so. Mr. Stupak. Is it fair to call them poultry farms? Mr. Rice. Yes. Mr. Stupak. Is the feed used in that poultry farm and all other things used, is it all generated from China internally or do you bring it in from Japan or the United States, the feed and other medicines and things like this you'd use? Mr. Rice. It's domestically sourced. Mr. Stupak. In China? Mr. Rice. Yes. Mr. Stupak. So those sources would also have to be certified then for feed and everything else? Mr. Rice. Yes. And for Japanese plants, for sure, because they have different requirements on residuals. Mr. Stupak. You, Tyson, have been there for how long, 20 years? Mr. Rice. I have been there 20 years. I think Tyson's been there about 5. Mr. Stupak. So this agreement they use with the Japanese for the company of Tyson just came about in the last 5 years? Mr. Rice. Yes. The Japanese certification process began about 3 or 4 years ago. Mr. Stupak. And that's because of an outbreak of illness they had in Japan, right? Mr. Rice. That's because of China's outbreak of avian influenza. Mr. Stupak. They didn't want to give it to Japan, so that's why they used the certification? Mr. Rice. Right. Mr. Stupak. Any reason why that certification would not work with the U.S.? Any reason why the U.S. could not go and certify? Mr. Rice. I don't believe so. I don't know why it wouldn't work. It's at least a good starting point to consider how to manage that process. Mr. Stupak. Mr. Martin, if I may, and Dr. Martin, thanks for being here. How do they determine whether specific farms and production facilities in China meets Japanese safety standards and thus able to export? How do they do that? Mr. Martin. Basically through a process whereby Japanese officials go over to China, meet with Chinese counterparts. They go out to the facilities and inspect it jointly. Mr. Stupak. Does Japanese have people permanently stationed in China? Mr. Martin. They don't have people permanently stationed there as far as I understand, but they have people who will go over there and check out facilities. Mr. Stupak. When does Japan inspect food shipments from China? Mr. Martin. When do they physically inspect the shipments? Mr. Stupak. Right. Mr. Martin. Japanese officials will inspect it when it arrives in Japan at the port. They will make a determination on whether or not that food shipment will be selected for inspection. Mr. Stupak. And you said there's three layers of inspections, right? Mr. Martin. Correct. Mr. Stupak. First comes in---- Mr. Martin. The first is not done by Japanese officials. They're basically relying on the Chinese system. And part of which Mr. Rice explained. The second part is when it comes into port and is clearing customs or is being brought in. If that particular shipment is selected for inspection, it goes to a quarantine center. There's 31 of them I understand in Japan where it will go through a physical inspection. If it passes the inspection, then it's released. The importers can take the shipment and then it goes into the market of Japan. But at that point, municipal authorities are prefectural employees. The equivalent of some state here will then inspect on the shelves on a regular basis. Mr. Stupak. In the testimony from our previous panel of our investigators here from the committee, we're talking about China's certification process. Japan doesn't rely on China's certification. They have their own certification process, is that correct? Mr. Rice. Japan,only for the poultry plants. Mr. Stupak. Right. Mr. Rice. For the 35 poultry plants that ship to Japan, the Japanese have certified their process. But when the product is shipped, AQSIQ is validating that was compliant with the Japanese law. Mr. Stupak. The point I was trying to get at, from the testimony, it looked like the Deputy Minister Wei was telling our group that if you just rely upon our system, it would all work. You would not have the problem with the melamine as you had because it wasn't certified by us. It was certified--but it sounds like there's--I wouldn't say a lack of trust but maybe a double checking or a check and balance system. Not only do you rely upon the Chinese system but you have your own certification. Japan has its own certification, or I should say inspection and certification. And even though China may have other certified farms, poultry farms, you rely upon the ones the Japanese have inspected and you inspect. Is that correct? Mr. Rice. That's correct. If you can understand it as, of all food processors in China, if you rely on that system, your universe of food companies that could be shipped to you is 450,000. So it's this big. If you rely on the AQSIQ system, that shrinks to 12,700. And in the case of the Japanese, they can shrink that to 35. Mr. Stupak. And then the premium you said was 30 percent more. Mr. Rice. It can be 20 to 30 percent more for price. Mr. Stupak. What would that mean for the average consumer, do you think? Just use your own product. Mr. Rice. Because that's not 100 percent of the cost of a product, it could mean a 10 percent to 15 percent increase in pricing. Mr. Stupak. Of the product? Mr. Rice. Right. Mr. Stupak. Each country can create its own food safety standards for Chinese imports. My impression is Japan has one set of standards, Hong Kong has another, and Russia has another you mentioned. Everyone has a different standard. You are shaking your head yes, right? Mr. Rice. Yes. I'm sorry. Mr. Stupak. That's all right. I think my time's expired. Mr. Burgess, Mr. Whitfield, questions? Mr. Whitfield. Thank you, Mr. Chairman. I'm sorry I missed you all's testimony a few minutes ago. But Dr. Martin, let me just ask you, what was your methodology in gathering information about the food safety systems in Japan and Hong Kong? Mr. Martin. Multiple systems. Hong Kong specifically, I lived there for an extended period of time. I continue to have contacts there. I worked there for a number of years. Similarly, I lived in Japan for a period of time and continue to have contacts back there. I also do have the standard contact with the Japanese Embassy here and the Hong Kong Economic and Trade Office here for asking for information, checked out scholarly materials on the information, looked at publications coming from U.S. Government agencies as well as other agencies, the Japanese agencies and the Hong Kong agencies overseas. I also checked the press and the media for information that's available. Basically as wide a search of materials as I could. Mr. Whitfield. And from your knowledge of the Japanese food safety system and the Hong Kong food safety system, are there any lessons that FDA could take from those two systems that could help improve its food safety system? Mr. Martin. I wouldn't use the word ``lessons.'' That would be an issue for them to make the determination of whether they see value or merit in a particular idea. What I tried to indicate in the written report, as well as my oral testimony, is that they seem to have methods that they find--Hong Kong and Japan that is--that they find to be effective in making or getting a reasonable level of surety of the safeness of the food that they're importing from China. And if you wish, could I specify, basically---- Mr. Whitfield. Yes. Just go over a few. Mr. Martin. Well, one of them goes back to a point that I saw or I heard in Mr. Stupak's question, which is when they find an incident, when there is a particular shipment that seems to be problematic, the response both in Japan and Hong Kong is to contact their counterpart in mainland China. And in both systems they are trying to develop a very rigorous traceability process. For example, all pork coming from mainland China into Hong Kong right now has a radio frequency ID tag on it. So they know exactly where that came from, which farm in mainland China that came from. What they do is they go back to the mainland authority and say, we have a problem here. It's generally framed in the terms, we have a problem here. How did this happen? How can we prevent it from happening again? So the approach is, we have a shared problem. Go back over. Go back through the system. Find out where it broke down in this three- tiered process and fix it. Mr. Whitfield. Right. Mr. Martin. So that would be one example of an observation of the approach in common in Hong Kong and Japan. Mr. Whitfield. Now Mr. Rice, you indicated that Tyson exports from the U.S. to China poultry product, correct? Mr. Rice. Yes. Mr. Whitfield. Now is that the whole chicken or is that chicken parts? Mr. Rice. It's chicken paws and wing tips mostly. Mr. Whitfield. Chicken paws and wing tips. Yet you have facilities in China where you produce chickens as well, is that correct? Mr. Rice. In China we don't grow chickens but we buy raw chicken meat from other producers and we make further processed products, like nuggets or patties. Mr. Whitfield. And you export that from China to---- Mr. Rice. To Japan and mostly to the domestic market in China. Mr. Whitfield. All right. And based on your experience do you feel that food can safely be imported from China to the U.S.? Mr. Rice. If the universe of exporters was narrowed down to AQSIQ-certified plants and they're inspected, I believe the Chinese can do it. Mr. Whitfield. And well, Mr. Chairman, I see that my time is just about expired. I want to thank you all for being with us today. We appreciate you taking time to give your expert advice. Thank you. Mr. Stupak. Further questions? Mr. Melancon. Mr. Melancon. And I'm not sure. But maybe Dr. Martin or Mr. Rice had experience. I'm hearing that China can monitor its exports when the importing countries require it. But the U.S. obviously doesn't demand this, which kind of makes me wonder, if Hong Kong, Japan and even the European Union don't allow tainted food, where does this tainted food go when they turn it down? Mr. Martin. In the case of Hong Kong and Japan, Japan will destroy tainted food that they capture and is quarantined in the testing process. And Hong Kong, I believe they also destroy the food. Mr. Melancon. If it goes to the European Union, do you know? Mr. Martin. I don't know about the European Union. Mr. Melancon. I'm of the understanding, at least on seafood, that they just ship it to another country, like the United States, that doesn't have the requirements. Mr. Martin. I couldn't comment on the European Union practice. Mr. Melancon. Maybe somebody could look into that. It goes back to that ad that I was shown for a company that's online that says, if you've got FDA-rejected food or if you've got food that's been rejected for importation, contact us, which tells me they're sending it someplace. Sort of like Mr. Burgess. I'm not sure who got those lead-tainted toys, but I'm sure somebody's going to get them. They're not just going to disappear. But thank you. I yield back my time. Mr. Stupak. Mr. Burgess, anything? Mr. Burgess. Thank you, Mr. Chairman. If I could, Mr. Rice. By an accident of marriage, I have family in Arkansas and so from time to time will travel in Arkansas and will see a lot of your company's logos. And the chicken-growing facilities that are licensed by Tyson seem to be pretty secure sites. You can't just wander into one. You have to be there for a reason. There seems to be a lot of reproducibility of the types of chicken houses and how they're constructed. So obviously your company goes to great pains to make sure that the product that is grown in our country meets their standards and presumably that is also product that's available for export now. You mentioned in response to a question that in China you don't grow your own chickens, but you do buy some raw material for export. And in your written testimony you say you practice 100 percent inspection on all raw materials coming into our facility. Can you kind of just give us a quick sketch of what that inspection comprises? Mr. Rice. Yes. Well, you are talking about our biosecurity, which is keeping the security clear so you can't contaminate your chickens with wild birds or other humans. And that exists in China and in the United States. When I was talking about the raw materials that we use to manufacture our products inside China, inside our plants, are raw chicken meat, flour, breading, oil and these things. And for everything that comes into our facility, we visually inspect it and we also test for residuals and chemicals. So I have eight full-time employees in a plant of 250 that only inspect incoming raw materials. So we want to be sure that 100 percent of what comes in is right before we make our product. Mr. Burgess. Now, do you ever find any problems? Mr. Rice. Yep, we do. That's why we keep that level of inspection. Mr. Burgess. When you find a problem, do you communicate that to say the U.S. authorities so that they know to be on the lookout of similar products in other facilities? Mr. Rice. No, we don't. Because these are local Chinese suppliers, and we are making product mostly for the Chinese market. So we would go straight to our supplier with our quality assurance team and inspect their facility and then look for why that problem came. Mr. Burgess. But there would be no dialog with, say, someone else who may be serviced by that same supplier to look out for the bad stuff that's in these chicken wing tips or whatever it is we're selling? Mr. Rice. No. But Tyson does not source raw materials from China at this time. Mr. Burgess. If you see a persistent problem coming from one supplier, what do you do to identify or do you identify that supplier to other companies or to U.S. authorities, to boy, be on the lookout for these guys. Mr. Rice. No, we would not. But we would stop using that supplier and switch to a new one. Mr. Burgess. The only clue that our guys, who are also over there tasked with making sure that products that come into this country are safe is that, hey, Tyson's is giving these guys the cold shoulder. Maybe we ought to look at other stuff coming out of their facility. Mr. Rice. There is no formal way to notify. Mr. Burgess. There is no formal way? Mr. Rice. No. Mr. Burgess. Not even as just an internal company policy, hey, if we find a bad problem, we're going to blow the whistle here and notify others? Mr. Rice. No. There's no procedure for that. Mr. Burgess. Dr. Martin, if I could ask you, I mean, in response to when you elaborated on the answer to Mr. Whitfield's question. You talked a little bit about some of the same issue about Hong Kong and Japan tracking problems if they identify problems. Is that not correct? Mr. Martin. Yes. That's common specifically in the case of the pigs or pork coming in from mainland China, yes. Mr. Burgess. So they do, they do keep some track of if there are persistent problems, it heightens their own internal security. But do they communicate with anyone else? Mr. Martin. Outside of Hong Kong, the Hong Kong Government and Japanese Government with mainland counterparts? Mr. Burgess. Yes. Mr. Martin. I do not know specific examples where the Hong Kong-Japan Government have contacted a fourth party, that is to say somebody other than mainland China, about the problem. Mr. Burgess. So they would not contact another foreign government, say, hey, if you're getting pig's feet from amalgamated pig's feet farm in wherever China, this is a problem for us and it may be a problem for you? Mr. Martin. The example you are giving is of a specific farm and a particular problem. I do not know of any particular case where they would do that. They do hold international meetings where they discuss common problems, we are noticing that a high percentage of this particular food product coming from mainland China is problematic; where is the source of the problem coming from? Mr. Burgess. So in general, there is discussion about where the hotspots are, where the problems are, is that correct? Mr. Martin. My sense of it from looking at the proceeds from those meetings, it tends to be at the technical level and on the product level. That is to say, we have a problem product that has this technical problem that comes up time and time again. I suspect on the next panel with USDA and FDA, they can, probably specifically talk about events of that sort because I am sure that they have had some in mainland China and in Hong Kong. Mr. Burgess. There would at least be a route for the authorities in this country to be notified of a problem that has occurred and is persistent? Mr. Martin. Yes, there are avenues of communication, sure. Mr. Burgess. But there is not a specific obligation to say, hey, this is trouble. Mr. Martin. There's nothing under current Japanese or Hong Kong law that requires those agencies to notify the international community it's a problem. Mr. Burgess. Thank you, Mr. Chairman. Mr. Stupak. Thank you, Mr. Burgess. Mr. Rice, does Tyson notify the Japanese officials if they find a problem with one of their suppliers, something coming into your plant? Mr. Rice. No. Mr. Stupak. But you receive your product from Japanese- certified suppliers? Mr. Rice. That's correct. Mr. Stupak. Why wouldn't you notify them? Mr. Rice. Because we're talking about isolated shipments where we might find foreign, foreign objects like hair or a piece of wood or something like that. Mr. Stupak. What if it was a chemical that shouldn't be---- Mr. Rice. Then we would notify the AQSIQ. And one process that might help, such a company would end up on the blacklist of the AQSIQ, which would be available publicly to all countries. Mr. Stupak. Well, yes, would the AQSIQ, whatever it is there, are they required to pass it down to the Japanese or just publish it? Mr. Rice. I don't know what the agreement is between AQSIQ and MAFF. Mr. Stupak. The growers or suppliers that you use, do they supply exclusively to Tyson and to Japan or can they--other countries or other processors like yourself? Mr. Rice. They would supply to multiple customers who would be part of their business. In general it's not more than 10 or 20 percent of their business is Japan and the rest would be a domestic market. It could be Southeast Asia or Korea as well. Mr. Stupak. We've indicated throughout this testimony that in Japan I think they inspect about 15 percent. U.S., it's less than 1 percent. Is there a number you think would be appropriate, 5 percent, 15 percent, 25 percent of the food products coming into this country should be inspected? Mr. Rice. I would not know that. Mr. Stupak. Dr. Martin, any guess on that? Mr. Martin. I couldn't give you a number. But what I would say is that my anticipation is that a statistician would ask you what's your goal or objective. Mr. Stupak. Mr. Rice, you said you have eight lab people or inspectors out of 250. What percentage of your budget is for safety, for inspection, for going to that farm to make sure things are right? Can you give me an estimate? Mr. Rice. I would guess it's between 3 and 4 percent. Mr. Stupak. Does Tyson use carbon monoxide when you ship any of the poultry? Mr. Rice. No, we do not. Mr. Stupak. No further questions. Thank you, Dr. Martin. Thank you, Mr. Rice. Thank you for your testimony. It was very helpful. We'll dismiss this panel and call up our third panel of witnesses. We have Dr. David Acheson, Assistant Commissioner for Food Protection at the Food and Drug Administration; Ms. Margaret Glavin, Associate Commissioner for Regulatory Affairs at the Food and Drug Administration. They're accompanied by Mr. Michael Rogers, Director of Field Investigations Division at the FDA; Mr. Domenic Veneziano, Director of Import Operations and Policy at FDA; and Mr. Donald Kraemer, Deputy Director of the Office of Food Safety and the Center for Food Safety and Applied Nutrition at the FDA. We also have Dr. Richard Raymond, who is the Under Secretary for Food Safety at the U.S. Department of Agriculture. Dr. Raymond is accompanied by Dr. Bill James, who is the Deputy Assistant Administrator for International Affairs at the USDA Food Safety and Inspection Service. It's a policy of this subcommittee to take all testimony under oath. Please be advised that our witnesses have the right under the rules of the House to be advised by counsel during their testimony. Do any of you wish to be represented by counsel? Everybody indicating they do not, so we will move forward. Please rise and raise your right hand to take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect the witnesses have replied in the affirmative. They are now under oath. We will now hear a 5-minute opening from the witnesses, and they may submit a longer statement for inclusion in the hearing record. Mr. Stupak. Dr Acheson, would you like to start for an opening statement? STATEMENT OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER, FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. Acheson. Good morning, Mr. Chairman and members of the subcommittee. I am Dr. David Acheson, Assistant Commissioner for Food Protection at the U.S. Food and Drug Administration. FDA Commissioner Andrew von Eschenbach has appointed me to this new position to provide leadership on strategic and substantive food safety and food defense matters. Thank you for the opportunity to discuss the important issues relating to the safety of imported food. FDA regulates everything Americans eat except for meat, poultry and processed egg products, which are regulated by our partners at the Department of Agriculture. The agency's committed to ensuring that the Nation's food supply continues to be as safe as possible. In recent years FDA has done a great deal to detect and prevent both unintentional and deliberate contamination of imported products. But we continue to face many significant challenges to food safety, including changes in consumer expectations, changes in production, manufacturing and processing techniques, increased globalization and terrorism. One of the major issues we face is the rapidly increasing level of food imports. Currently FDA oversees more than 9 million line entries of imported food annually. Shipments of food represent about 60 percent of FDA regulated imports. We're looking to enhance product safety by broadening our knowledge and applying enhanced risk-based criteria to the entire life cycle of imported products. The President is engaged directly in the effort to ensure that FDA and other agencies are doing everything we can to protect Americans from unsafe imports. On July 18, the President issued an Executive order creating a Cabinet level Working Group on Import Safety, which I will discuss in more detail later. My priority assignment as Assistant Commissioner is to coordinate the development of a new Food Protection Strategy. This will enhance our food safety and food defense systems by addressing the challenges we face. The Food Protection Strategy will be comprised of three fundamental elements: First, a proactive prevention strategy to build safety in from the start; second, risk-based interventions to ensure preventive approaches are effective; and, third, rapid responses when contaminated food is detected or when there's harm to humans or animals. This integrated approach will build on existing partnerships with industry, other regulators and consumers and fully utilizes advances in technology. FDA's overall goal is to ensure a comprehensive and robust food safety and food defense program that will provide the level of food protection American consumers expect. With regard to imports, we need a fundamental shift from the current model that relies on snapshots at the border to a cost-effective prevention focused model that identifies and targets those steps in the life cycle of imported food where the risks of unsafe products are greatest. This model is consistent with the President's Interagency Working Group on Import Safety. The working group includes members from 12 Federal departments and agencies, and its mission is to review the procedures, regulations and practices under which we manage the safety of all imported consumer products. The Secretary of Health and Human Services, Michael Leavitt, chairs the working group and FDA plays a key role. Secretary Leavitt and Commissioner von Eschenbach have traveled extensively throughout the United States during the past few months. The insights that they've gained during their reviews helped shape the strategic framework that was released by the working group on September 10. That report outlines an approach, like FDA's Food Protection Strategy, that's based on the organizing principles of prevention, intervention and response. With respect to the recent well-publicized issues with regard to the safety of imported products from China, FDA's conducting a series of meetings with Chinese officials to negotiate memoranda of agreements aimed at creating a framework to help assure the safety, quality and effectiveness of products exported from China to the U.S. The agreements also aim to increase cooperation and information sharing between the regulatory bodies of the two nations with a goal of strengthening China's regulatory process. These negotiations are ongoing, with a goal of finalizing the agreements by year's end. Ensuring the safety of imported foods is a difficult task, but I want to ensure you that FDA is diligently working to efficiently and effectively use the resources and authorities we have been provided by Congress to help protect American consumers. Thank you for the opportunity to discuss FDA's activities to enhance the safety of imported food. I would be happy to answer any questions you may have. [The prepared statement of Dr. Acheson follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you, Dr Acheson. Ms. Glavin, opening statement, please. STATEMENT OF MARGARET O'K. GLAVIN, ASSOCIATE COMMISSIONER, REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; ACCOMPANIED BY MICHAEL C. ROGERS, DIRECTOR, DIVISION OF FIELD INVESTIGATIONS, OFFICE OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, DOMENIC J. VENEZIANO, DIRECTOR, DIVISION OF IMPORT OPERATIONS AND POLICY, OFFICE OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, AND DONALD W. KRAEMER, DEPUTY DIRECTOR, OFFICE OF FOOD SAFETY, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION Ms. Glavin. Good afternoon, Mr. Chairman and members of the committee. Thank you for inviting me. I'm Margaret Glavin. I'm the Associate Commissioner for Regulatory Affairs at the Food and Drug Administration. The Office of Regulatory Affairs is the lead organization within FDA responsible for enforcing FDA's public health laws and regulations. We're guided in our mission, which is to protect consumers and enhance public health by maximizing compliance of FDA-regulated products and minimizing risks associated with those products. To meet these responsibilities, ORA is staffed with a workforce of approximately 3,200 employees, 2,700 of whom are dispersed geographically throughout the country. My testimony today will discuss ORA's import operations and the tools we have at our disposal to prevent adulterated or misbranded imported goods from entering domestic commerce. I will also provide an overview of the challenges that confront us and measures that are being contemplated to enhance our coverage of imported goods. In July, when I testified before this committee, I discussed ORA's proposed Transformation Initiative, a component of which involved consolidating FDA's field laboratories. That effort, including the proposal to close laboratories, is no longer under consideration. What remains as relevant today as it was in July are the challenges that confront ORA in our efforts to fulfill our mission to protect the public health. These challenges have not gone away and are continuing to grow. For these reasons ORA has undertaken a planning process that examines how we can best meet our future needs and public health mandates. This process, which is drawing on the experience, expertise and input of all ORA employees, will allow us to be more strategic in our efforts to ensure that we invest in the right tools, skill sets and programs to meet the challenges posed by emerging threats, ongoing public health emergencies, increasingly complex technological advances in the industries we regulate and burgeoning imports, one of the topics this committee is addressing today. The volume of goods offered for entry into the United States is growing exponentially, and these imported products include every type of FDA-regulated product and come from more than 200 countries and more than 300,000 manufacturers worldwide. As has been said many times this morning, we physically inspect less than 1 percent of the imported food that is offered for entry into the U.S. To better ascertain which food we ought to physically inspect, FDA uses a number of approaches to help us make risk-based decisions. One of these involves having FDA inspectors conduct inspections of foreign manufacturing facilities that export FDA-regulated goods to the U.S. to make certain that they are following good manufacturing processes and other regulatory requirements, such as HACCP for seafood and juice products. In addition, we conduct outreach to food processors and food producers in foreign countries to enhance their understanding of food safety and good agricultural practices. FDA also works with and provides training to our regulatory counterparts in foreign countries. This training focuses on U.S. public health requirements and methods to improve food safety in order to ensure that exporters are able to meet our requirements, and FDA works with our foreign regulatory counterparts to share information regarding each country's laws, requirements and food safety systems and which also allow for notification to each other when significant violations are found. In 2002, Congress provided us with significant new authorities to enhance the protection of the food supply through the provisions of the Bioterrorism Act. FDA utilizes a significant new tool provided under this act that requires us to receive prior notification before food is imported or offered for import into the United States. Advanced notice of imported food shipments allows us, with the support of Customs and Border Protection to electronically screen the shipments for potentially serious threats to health before the food arrives and to target those products flagged by the system as presenting the most significant risk. This allows us to conduct more intensive import security reviews on potentially high-risk entries and to allocate resources for inspections more effectively. All prior notice data is validated against FDA's OASIS system for completeness to ensure that it meets minimal data submission requirements. Once the data is validated, it is screened against specific food security criteria established in the system to identify and flag high-risk shipments. Prior notice of high-risk screening criteria are based on a number of factors, including risk assessments conducted in accordance with operational risk management and CARVER plus Shock methodologies to identify those food shipments that present the highest food security risk and are most vulnerable. Additional screening criteria are established based upon contemporary intelligence reports. To conduct intensive, manual high-security reviews, the prior notice staff utilizes information contained in internal FDA data systems, as well as those of other agencies such as CBP and the Treasury Enforcement Communication System to further assess specific risks associated with subject food shipments as well as any links that parties associated with the shipment may have to terrorist organizations or criminal intelligence records. They also consider anomalies in shipping patterns and past shipping histories. Based on these risk factors, the prior notice center staff makes the determination whether the shipment poses a significant security risk to the American people. Those shipments of imported foods that are determined to pose a significant security risk are held upon arrival in the U.S. for joint examination by FDA and CBP personnel. Those shipments that are not deemed to be a security risk are released for an import admissibility review for food safety concerns. Another significant provision of the BT Act provided FDA with the authority to commission CBP employees to conduct examinations and investigations of imported foods on FDA's behalf so that they can assist us in the examination and investigation of imported food at ports of entry or other facilities and locations in close proximity to such ports. This provides FDA with operational assistance from our CBP colleagues when necessary and has proven to be useful, especially at remote ports of entry. After prior notice requirements have been met, incoming shipments are subject to an admissibility decision as to whether or not a particular shipment of imported food should be allowed to enter domestic commerce. To make this decision, we often use targeted examinations called physical examinations or field examinations. A field examination is a visual examination of a product to determine whether the product is in compliance with our requirements, and it involves actual physical examination of the product for admissibility factors. In addition, a field exam can be supplemented with other activities such as sample collections and analyses for microbiological or chemical contamination. When relevant product information is gathered from our domestic surveillance and inspection program, FDA factors this information into its import decisionmaking process. Another key tool used to screen imports is the import alert. Import alerts are used to provide direction to our field personnel indicating that FDA has sufficient evidence or information about a particular product to refuse admission of that article being offered for entry without physically examining the product. This is a practice that was referred to as detention without physical exam. Mr. Stupak. Can you summarize, please. Ms. Glavin. Absolutely. As I said, we do those things. We also determine if an imported product should be denied. And once we determine that an imported product should be denied entrance into the U.S., a notice of detention and hearing is issued. We detain the goods, and we allow the importer to present evidence supporting the admissibility of the questionable goods. Based upon our review of the evidence, we may release the goods. But if we maintain our position that the goods cannot be allowed admission into the U.S., the goods must either be destroyed or reexported within 90 days. As I described in my testimony today, we use our available tools and authorities to manage the ever-increasing volume of imported food to achieve the greatest protection possible. And ensuring the safety of the food supply continues to be a top priority of the FDA. As Dr. Acheson has indicated, FDA, including ORA, understands the need to focus our resources to improve consumer protection in the import arena and is committed to moving towards a cost-effective prevention focus model that identifies and targets those steps in the life cycle of imported products where the risk of unsafe products are the greatest. Thank you for the opportunity to testify, and I'll be pleased to answer any questions. Mr. Stupak. Dr. Raymond, please. Opening statement. TESTIMONY OF RICHARD RAYMOND, M.D., UNDER SECRETARY, FOOD SAFETY U.S. DEPARTMENT OF AGRICULTURE; ACCOMPANIED BY BILL JAMES, D.V.M., DEPUTY ASSISTANT ADMINISTRATOR FOR INTERNATIONAL AFFAIRS, FOOD SAFETY AND INSPECTION SERVICE Dr. Raymond. Yes, sir. Mr. Chairman and members of the subcommittee, I'm very pleased to have the opportunity to appear before you here today. I am Dr. Richard Raymond, Under Secretary for Food Safety at the USDA, and I'm here to discuss how the USDA regulates meat, poultry and egg products to protect American consumers. As the Under Secretary for Food Safety, I do oversee the Food Safety and Inspection Service, FSIS. FSIS is the USDA public health regulatory agency responsible for the administration of laws and regulations that are designed to ensure that the Nation's commercial supply of meat, poultry and egg products is safe, wholesome and properly labeled regardless of whether those products are sold in the United States or imported to or exported from the United States. In contrast to the rise seen in other imported products, the amount of FSIS-regulated imported meat and poultry products has remained approximately the same in the last 5 years, hovering around 4 billion pounds of meat and poultry from the 33 countries that have equivalent food safety systems. In that time, the amount of imported product that was detained, destroyed or returned has doubled as we have become more effective in what we do. FSIS employs a comprehensive three-part system for imports that helps to ensure the safety of imported product. This system consists of, one, establishing the initial equivalence of the meat, poultry or egg product inspection system of the country wishing to export to the United States; two, verify and continue equivalence of foreign systems through annual audits; and, three, providing 100 percent reinspection with a few exceptions when products enter the country. Equivalence is the foundation for our system of imports. It recognizes that an exporting country can provide an appropriate level of food safety even if those measures are different from those applied here in the United States. FSIS begins the process of determining equivalence by analyzing the country's meat or poultry regulatory system with a document analysis to assess whether the country has the laws, the regulations and the infrastructure to support an equivalent system. This document review focuses on a country's practices and five risk areas. They are sanitation, animal diseases, slaughter processing, residues and enforcement. If the document review is satisfactory, then the process of determining equivalence moves to the on-site review. During an on-site review, an FSIS audit team evaluates all the aspects of a country's inspection program from the headquarters of the inspection system to regional offices and local offices, and ultimately to individual establishments within the country, and to laboratories that will be testing the product that is destined for the United States. The second part of our system is to verify continuing equivalence through audits. This means that once a country is determined to have a system equivalent to the United States system, that country is then responsible for ensuring that the entire system that is exporting to the United States employs standards equivalent to those of the United States. To verify that this is happening, FSIS conducts annual audits of foreign food safety systems and procedures through on-site visits by FSIS personnel, including certified establishments, laboratories and review of the government's controls. If a country fails an audit, FSIS can, and we have in the past, suspend imports from that country from individual plants or for specific products. Finally, the last part of our system for ensuring the safety of FSIS-regulated imports is verifying the continuing equivalence of foreign systems through reinspection of products at the border at our 140 import houses. It is here that the initial checks for proper documentation, evidence of tampering, transportation damage and proper labeling are conducted. In addition to the initial reinspection of product entering the United States, FSIS then performs intensive random reinspection on approximately 10 percent of the shipments of meat, poultry and egg products. More intensive reinspections are automatically applied to future shipments of product from a foreign establishment when that product fails reinspection. Access to Customs and Border Protection's Automated Commercial Environment database has provided FSIS with a more targeted approach to identifying and controlling ineligible entry of FSIS-regulated products that did not present to an import house for reinspection as required, and it gets us closer to the entry point rather than chasing it down after its release in commerce. Use of the ACE database is one of our many success stories. While the amounts of imports have been stable, we've markedly increased the amount of detected ineligible product using existing personnel through a collaborative effort with our Federal partners at CBP. In fiscal year 2005, prior to FSIS's use of the ACE system, the amount of ineligible product removed from commerce that did not pass the import houses was a little over 36,000 pounds. In fiscal year 2006, this amount increased to 1.6 million pounds. In the fiscal year 2007, 2.1 million pounds was identified, destroyed or redirected to FSIS for reinspection. That is more than three AirBus 3AD jetliners' worth of product in fiscal year 2007 alone. Our three-part approach to imports is supplemented by our critical food defense efforts that protect against accidental or intentional food contamination. Dr. Acheson has already mentioned the Interagency Working Group on Import Safety, and I will not repeat many of his comments except to say that I do represent the USDA on that panel, so I do have working knowledge of its products and how it is going about its business. I'd now like to take just a moment to clarify the current status regarding the importation of FSIS-regulated poultry product from China as they requested in April of 2004. As I mentioned earlier, any country can apply to be evaluated for equivalence by submitting a request to FSIS. This is exactly what happened when China requested the authority to export poultry to the United States in 2004. After careful study, China's poultry-processing inspection system was determined to be equivalent to our own. In addition, the Animal and Plant Health Inspection Service found no risk to U.S. animal health from import of this type of product if it meets the cooking standards as approved by APHIS. After the formal rulemaking process was concluded, China was then added to the list of countries eligible to export processed poultry, But the poultry they could process would have to come from either the United States or another country that is approved to export raw poultry products to the United States. In essence, we're talking about processed poultry originating from Canada or the United States, not poultry raised and slaughtered in China. Currently no plants from China are exporting processed poultry originating from the United States or any other country to the United States. In addition, USDA has not published a rule permitting China to export to the United States poultry that is raised and slaughtered in China. I want to assure everyone that we do have a strong system in place for imported products regulated by the USDA. I believe that our approach to regulating the safety of imported meat, poultry and egg products is one of the best systems in the world. This is due to our rigorous three-part approach determining the initial equivalence, the continuous evaluation of that equivalence through annual audits, and our vigilant surveillance of meat, poultry and egg products entering the country. Mr. Chairman and all members of this subcommittee, I'd like to thank you for this opportunity to explain the important process that FSIS employs in protecting consumers by ensuring the safety of imported food products. I do look forward to your questions. Mr. Stupak. Thank you. [The prepared statement of Dr. Raymond follows:] Testimony of Richard Raymond, M.D. Mr. Chairman and Members of the SubCommittee, I am pleased to appear before you today. I am Dr. Richard Raymond, Under Secretary for Food Safety. I am here to discuss how the United States Department of Agriculture (USDA) regulates the importing of meat, poultry and egg products to protect American consumers. As the Under Secretary for Food Safety, I oversee the Food Safety and Inspection Service (FSIS). FSIS is the USDA public health regulatory agency responsible for the administration of laws and regulations that are designed to ensure that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled, regardless of whether those products are sold in the United States or imported to, or exported from, the United States. The amount of FSIS regulated meat and poultry imported products has remained approximately the same over the past five years, hovering around four billion pounds of meat and poultry from 29 of the 33 eligible countries. However, egg product imports have increased in this past year. FSIS employs a comprehensive three-part system for imports that helps to ensure the safety of imported product. This system consists of: <bullet> Establishing the initial equivalence of the meat, poultry and egg product inspection system of a country wishing to export to the United States; <bullet> Verifying continuing equivalence of foreign systems through audits; and <bullet> Providing 100 percent re-inspection, with a few exceptions, when products enter the country. Establishing Equivalence Equivalence is the foundation for our system of imports. It recognizes that an exporting country can provide an appropriate level of food safety, even if those measures are different from those applied here at home. FSIS has always required an assessment of foreign inspection systems before those nations can export to the United States. This prior review is mandated by our laws, which originally required that a foreign system be ``equal to'' our system before the foreign product could be admitted. That standard was changed in 1994, to one of equivalency after the United States signed the Final Act of the Uruguay Round of Multilateral Trade Negotiations. Any country can apply for equivalence by submitting a request to FSIS. An importing country maintains the sovereign right to maintain any level of protection that it deems appropriate to address food safety hazards within its borders. An exporting country has the burden of proving that its system is equivalent to our own if that country wishes to export to the United States. FSIS begins the process of determining equivalence by analyzing the country's meat or poultry regulatory system with a document analysis to assess whether the country has the laws, regulations, and an infrastructure to support an equivalent system. This document review focuses on a country's practices in five risk areas: sanitation, animal disease, slaughter and processing, residues, and enforcement. FSIS uses the document review to ensure that the country has in place measures that encompass the standards, activities, resources, and enforcement mechanisms inherent in the US regulatory system for these five areas. If the document review is satisfactory, the process of determining equivalence then moves to on-site review. During an on-site review, an FSIS audit team evaluates all the aspects of a country's inspection program, from the headquarters of the inspection system to regional offices and local offices, and ultimately to individual establishments within the country and to laboratories that will be testing product destined for the United States. Through these evaluations we seek assurances that the country's inspection program is, in fact, what the documentation claims. The process for announcing initial equivalence determinations for foreign countries is open and transparent. When FSIS makes an initial equivalence determination, a proposed rule is published in the Federal Register setting forth the determination and our reasoning for it. After a comment period, FSIS reviews all comments submitted on the proposal and, as appropriate, publishes a final rule to add the country as eligible to export meat, poultry or egg products to the United States. This ensures an open and transparent process. Verifying Continuing Equivalence through Audits The second part of our system is to verify continuing equivalence through audits. This means that once a country is determined to have a system equivalent to the United States, that country is then responsible for ensuring that the entire system exporting to the United States employ standards equivalent to those contained in the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act. FSIS conducts annual audits of foreign food safety systems and procedures to verify that this is taking place. This process includes on-site visits by FSIS personnel, including certified establishments, laboratories and a review of government controls. There is a particular focus on implementation of any new requirements we have put forth since the last audit. For fiscal year 2007, FSIS visited 145 establishments, 39 laboratories, and 86 government offices in the process of auditing all countries actively exporting to the United States. The final audit reports of these countries are posted on the FSIS Web site. If a country fails and audit, FSIS can, and has in the past, suspend imports from that country, from individual plants, or specific products. Verifying Continuing Equivalence through Re-inspection at the Border Finally, the last part of our system for ensuring the safety of FSIS-regulated imports is verifying the continuing equivalence of foreign systems through re-inspection of products at the border. Every shipment of meat, poultry, or egg products that enters the United States must be presented to an FSIS inspector at one of the approximately 140 official FSIS import establishments strategically located at major ocean ports of entry and land border crossings. It is here that the initial checks for proper documentation, evidence of tampering, transportation damage, and proper labeling are conducted. This process is currently assisted by FSIS' Automated Import Information System (AIIS). AIIS is a database that schedules re-inspection tasks and stores the results of the re-inspection from each point in the process. In addition to the initial re-inspection of product entering the United States, FSIS performs intensive random re- inspection on approximately 10 percent of the shipments of meat, poultry, and egg products. These re-inspection tasks include product examinations, microbiological analysis for pathogens, and/or a test for chemical residues. Acceptable products are marked as ``Inspected and Passed'' and released into commerce. Non-compliant products are rejected, marked as ``Refused Entry,'' and either destroyed or returned to the originating country. More intensive re-inspection is automatically applied to future shipments of product from the foreign establishment when product fails re-inspection. I would like to take a moment to discuss the laboratory system that FSIS relies on to carry out these more intensive inspections. Depending on where the samples are taken, they are shipped to the Eastern, Midwestern, or Western laboratories. These three laboratories are operated by FSIS and are staffed with FSIS personnel. We are constantly working to enhance the capacity of these labs so they are prepared to respond to food emergencies that can be caused by a vast array of contaminants. Indeed, in recognition of our interest in keeping these laboratories up-to-date, we requested $2.5 million in fiscal year 2008 to enhance these important labs. The important work carried out by import re-inspection personnel I described earlier is supplemented by the twenty- three Import Surveillance Liaison Officers (ISLOs) currently employed by FSIS. These ISLOs are charged with identifying, tracking, and detaining ineligible, illegal, or smuggled product. Like our import re-inspection personnel, they work regularly with other agencies, including Customs and Border Protection (CBP), USDA's Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA), and the U.S. Fish and Wildlife Service, as well as brokers and importers at U.S. ports of entry. Access to CBP's Automated Commercial Environment (ACE) database has provided FSIS a more targeted approach to identifying and controlling ineligible entries of FSIS-regulated product closer to the entry point, rather than after its release into commerce. In fiscal year 2005, prior to FSIS' use of the ACE system, the amount of ineligible product removed from commerce that did not pass through import houses was a little over 36 thousand pounds. In fiscal year 2006, this amount increased to 1.6 million pounds, and in fiscal year 2007, 2.1 million pounds was identified, destroyed, or redirected to FSIS for re-inspection. The Agency and other key Federal partners are working to become fully integrated with CBP's ACE system. This effort will eventually lead to a linkage of all inspection and border control data systems, known as International Trade Data System (ITDS), across all Federal agencies involved in imports. Food Defense Our three-part approach to imports is supplemented by our critical food defense efforts to protect against accidental or intentional food contamination. To this end, the Agency performs vulnerability assessments for imported food and, potentially, for food that has illegally entered the U.S. market. These vulnerability assessments help us to strengthen our food import system. Armed with these vulnerability assessments, the Agency conducts ongoing training to increase awareness of food defense issues among our international trading partners. FSIS inspectors also engage in ongoing and comprehensive training and education efforts that assist them in preventing and responding to any potential threat to the food supply. Coordinated food defense awareness training is conducted in locations nationwide in conjunction with our food defense partners throughout government. They include the Department of Homeland Security (DHS), the Department of Health and Human Services (HHS), other USDA agencies, as well as State and local food defense partners. FSIS is working jointly with FDA on the continued development of the Food Emergency Response Network (FERN) with other national, State, and local laboratories to provide ongoing surveillance and monitoring of food and to prepare for emergency response stemming from a food illness outbreak, intentional contamination, or even a hoax. In addition, FSIS is participating in a consortium of lab networks developed by DHS. This integrated consortium will improve coordination among Federal and State partners that are focused on food and agriculture issues. In the process, it will ensure consistency of methods development and the reporting and sharing of lab results between Federal and State partners. FSIS has also developed and distributed model food security plans for use in import establishments. These plans help the importers develop a personalized Food Defense Plan that takes into account the unique characteristics of the establishment. Finally, while import inspectors conduct their regular re- inspection at import facilities, their activities also include efforts aimed at protecting consumers from intentional attacks on the food supply. These activities include facility checks to identify, among other things, suspicious activities in product re-inspection or port areas, evidence of product tampering, or signs that a facility's water supply may have been compromised. The specific procedures performed change according to the threat level. Interagency Working Group on Import Safety Mr. Chairman, I have gone over how imported meat and poultry products are currently inspected through a systems approach, reviewed our re-inspection procedures at our border and detailed how our food defense efforts improve our effectiveness. USDA is also working closely with the recently formed Interagency Working Group on Import Safety to look at what we can do better. As the USDA representative for the working group, I am speaking from first hand experience. The President formed this Working Group, which is chaired by Health and Human Services Secretary Michael Leavitt, to ensure that we are doing everything we can to promote the safety of imported products. The mission is critical--and that is to conduct an across-the-board review of import safety by U.S. importers, and by Federal, State, and local governments. It has also been given the task of providing recommendations to the President that will help to further improve the safety of imported products. In September, the Working Group issued a strategic framework for doing more to ensure the safety of imported products. This framework outlines a risk-based approach that includes the principles of prevention, intervention, and response. The framework supports USDA's long-standing approach to evaluating and verifying the ability of foreign food safety systems to meet food safety requirements for meat, poultry, and egg products exported to the United States. The next step in advancing the framework will be the Working Group's mid-November release of an implementation action plan. The action plan will provide specific short- and long-term recommendations for import safety improvements and will reflect stakeholder input received through several outreach activities conducted over the past two months, as well as from a public meeting that was held on October 1 at USDA headquarters here in Washington. I want to assure everyone that we have a strong system in place for imported products regulated by USDA. I believe that our approach to regulating the safety of imported meat, poultry, and egg products is the best system in the world. This is due to our rigorous three-part approach: determining initial equivalence; the continuous evaluation of that equivalence to ensure that it is maintained; and our vigilant surveillance of meat, poultry and egg product entering the country. The safety of our food supply is also due in large part to the work of our food safety partners. But the state of public health is constantly evolving, and we must be sure we're evolving with it. We cannot afford to let ourselves, our food safety partners, or our nation's food safety systems grow complacent. That is why the Import Safety Working Group is so important. It gives us an opportunity to step back and look at how we can improve our vital import inspection procedures. We all know that we can protect consumers with sensible policies, and together we will do just that. Mr. Chairman and all Members of the Subcommittee, I would like to thank you for this opportunity to explain the important process that FSIS employs in protecting consumers by assuring the safety of imported food products. ---------- Mr. Stupak. Dr. Acheson, if I may, I will start questions. We heard Mr. Rice with several countries, in fact even Tyson Foods, that have their own certification process in China. Why doesn't the U.S. have a certification process in China? Dr. Acheson. There is a complex answer to that. A lot of the ground has been covered on that already earlier on. But let me try to summarize from the FDA's perspective. We are able to hold the product, inspect the product at the port of entry if there is an appearance of adulteration. That is a fairly low bar. Right now we do not have the authority at FDA to require certification from a foreign country. Mr. Stupak. Are you trying to tell me you need specific requirement from Congress to go certify farms and food producers in China? Dr. Acheson. It depends on what you mean by certification. If you are talking about certification as a requirement for entry into the United States, then we would need a specific legal authority to require that as a reason to refuse if it doesn't have the certification. Mr. Stupak. So the United States--Russia has one, Japan has one, Hong Kong has one, all of them. Are you saying they all have legislative authority to do that before they can have certification of farms in another country to bring it in? Dr. Acheson. I'm not familiar with the laws in Russia or those other countries, but in the United States, my understanding of U.S. Law is, yes, we would require that legal authority to put in place a system whereby we require certification of certain products from particular countries. We don't have that currently. Mr. Stupak. You talked about this Import Working Group that is working, and you indicated the President is directly involved in it. Is certification of farms or food-processing plants in other countries part of that discussion you're having in this working group? Dr. Acheson. I think certification is part of the general discussion that is being had around--certainly with regard to ensuring the safety of imported products. But again, as it has come out in the earlier panels, one of the things that we need to be certain of at FDA with regard to food safety and food defense is what does that certification mean. Simply having a piece of paper that is a certificate may not be adequate. If we set that system up, we have to verify that that certification system is working to a level that meets the standard that we're comfortable with. Mr. Stupak. Well, if we're not certifying, we're only inspecting 1 percent of food coming into this country. We're not keeping the American people very safe then, are we? If you're not certifying the farms, you can't certify the food coming in, you can only certify 1 percent, and 99 percent is not inspected. So how can you assure the American people that the food they're consuming is going to be safe? Dr. Acheson. What we're doing is we're reacting when problems occur. Mr. Stupak. How can you react? You don't even have recall authority. Dr. Acheson. We can undertake recalls voluntarily with firms, and we do that on a regular basis. Mr. Stupak. The firm has to voluntarily do it. Dr. Acheson. Exactly. But what we recognize is that there is a need to build prevention up front. That is where we're headed. Mr. Stupak. For prevention up front, wouldn't you want to certify the farm or the processing plants that are processing the food before it comes here? Isn't that really the first upfront line of defense you could have. Dr. Acheson. You certainly need to ensure that the product is being manufactured safely, whether it be domestically or from China or India or wherever. Certainly requiring certification is an option that is under consideration as part of that process. Mr. Stupak. Well, let me ask you this. The produce industry has called on the FDA to enact tough new regulations regarding the handling of fresh produce; however, the FDA has not done this. And according to--right there is the exhibit book, exhibit No. 20, an article from the Wall Street Journal in February, Health and Human Services officials rejected the FDA's plan for tough new regulations on the handling of produce. Is it true that the FDA sought mandatory regulations but were overruled by HHS. Dr. Acheson. I wasn't part of that particular meeting, but my understanding of that was that the FDA did not take requests for specific mandatory regulations to HHS. Mr. Stupak. What did they do with them? The produce industry has been calling for you to do it. According to news reports, the FDA brought it to HHS. So that is not true, they never brought it to HHS. Dr. Acheson. Those earlier meetings with HHS were high- level discussions around food safety in general. At that time that was fairly recently after we had had spinach and---- Mr. Stupak. Most produce---- Dr. Acheson. Yes. But it was not a specific request for authority that was ultimately turned down. Mr. Stupak. So it was ultimately turned down? Dr. Acheson. No, I said it was not a specific request for authority that was---- Mr. Stupak. So you had high-level meetings. What came of the high-level meetings, anything? Dr. Acheson. Absolutely. Part of those high-level meetings was a recognition that we needed to step up and do different things to face these new challenges. That's one of the reasons why Commissioner Von Eschenbach created my position and instructed me to develop a food-protection plan, which we're working on, which I anticipate will be launched sometime within the next month or two. Mr. Stupak. What can you tell us in this committee that is going to be preventive so we can prevent the action of people getting sick like on E. coli? And again, I agree it came from spinach from Salinas Valley, the hearings we have had on it. But what are you doing to prevent that? Dr. Acheson. There are a number of things. To put preventive strategies in place, you have to understand what caused the problem in the first place. Again, as has been alluded to earlier, the close proximity of cattle to a spinach field may be---- Mr. Stupak. That has been going on for 10 years. We've had 20 outbreaks, and the FDA has done nothing to prevent the cattle from polluting the water so it doesn't go on the spinach fields. So where is the preventive action here? You haven't even done an epidemiology study to figure out where it is coming from. Dr. Acheson. What you're alluding to there is the need of the basic sciences to put those preventive strategies in place. That is not all there. Mr. Stupak. If we don't have basic science, how are we going to have advanced science to inspect food? Dr. Acheson. You need the basic science principles to understand how E. coli gets on the spinach in the first place. Yes, we know it is in cattle, but is it coming via the water, via wild animals. Mr. Stupak. That's why an epidemiology study would determine that; would it not? Twenty outbreaks in ten years and you still haven't determined that. You haven't even requested an epidemiology study, have you. Dr. Acheson. We certainly recognize there is the need for that science, and we have not---- Mr. Stupak. So are you going to recommend an epidemiology study for Salinas Valley, the Salad Bowl of America. Dr. Acheson. What we're going to do is to focus more than on leafy greens in the Salinas Valley. There is a need for more science. Mr. Stupak. But are you going to ask for an epidemiology study to try to get down to the source of the E. coli bacteria which pollutes the Salinas Valley, which ends up in 20 outbreaks in 10 years? Dr. Acheson. You're absolutely right. One of the key questions is to answer that. An epidemiology study is maybe a mechanism to get to that. How does the E. coli get from the cattle to the spinach? It is a key question. There is no doubt about that. Mr. Stupak. Key question? When are you going to study it or do an epidemiology study. Dr. Acheson. The Food and Drug Administration is not a research agency. Mr. Stupak. I'm not asking you to do research. Don't you have to have the study be done? Dr. Acheson. The FDA doesn't have the resources to require that study, but we certainly put out to our research colleagues---- Mr. Stupak. You've been the drug czar for some time now. Have you asked for money to do an epidemiology study? Have you asked for more money from the OMB to do inspections? Dr. Acheson. As part of the budget process of 2009 and the rolling out of the Food Protection Plan, we've recognized that in order to get where we need to go, we will be needing new resources, yes. That is part of the ongoing process. Mr. Stupak. So you haven't asked for it yet, but you think you will in 2009? Dr. Acheson. That budget process has to follow its tracks. And we recognize that that is just the way the system is set up. Mr. Stupak. I'm over my time. I'll turn to Mr. Whitfield for questions. I'm sure we'll have another round of questions here. Mr. Whitfield. Thank you, Mr. Chairman. Dr. Acheson, you and Ms. Glavin both have a responsibility for protecting the food supply in the U.S., which is an awesome responsibility. And with your expertise and with your experience and with that responsibility, what concerns you most from your position about guaranteeing the safety of the American food supply? What are two or three things that concern you the most? Dr. Acheson. I think the principal concern is to move away from a reactive situation in responding to outbreaks when somebody is sick to building in safety up front, whether that be domestic, as we've just been discussing with regards to spinach, or whether it be from an imported product. I believe the key to success is to build in preventive strategies at the manufacturing level right up front, wherever that is happening, domestically or foreign. Mr. Whitfield. What kind of progress are we making in doing that? Dr. Acheson. The progress that we're making is determining what would be the steps to get there. That is a significant part of the Food Protection Plan that we're talking about, a shifting emphasis into prevention, yet maintaining inspections, focused on risk. Again, the prevention has to be focused on risk and building a more robust response system. We do respond well already, but I would be happier if we were even faster getting a handle on illness quicker, to get it off the shelves faster and protect consumers. Mr. Whitfield. So one thing, then, is going from a reactive to a more preventive method? And we're not there yet. And what is the second thing? Dr. Acheson. Well, I've summarized that with the focused, risk-based inspections. We need to continue to inspect, obviously, but those inspections need to be focused in the areas of greatest risk. And as part of that, which is the third point, is the need to integrate that with modern technology; not just information technology, which is critical, especially in the area of imports, of getting better, faster systems to integrate the mountain and the ever-increasing amount of information, but also detection technology. We need to be able to detect problems in foods faster, hopefully in a matter of hours as opposed to days. So we need to build those in as well. Mr. Whitfield. Well, I notice that the largest import refusals come from Mexico, China and India. So how often do we send inspectors to those countries to look at their facilities, or do we? Dr. Acheson. I think in the last year--and my colleagues can give you the specific numbers there. It is in the order of 100 to 150 foreign inspections we've done. We can certainly provide you information on which countries that we have---- Mr. Whitfield. Are budgetary concerns an issue there or not? Dr. Acheson. Certainly the amount of inspections that we do both domestically and foreign are limited by resources. Mr. Whitfield. What is the overall budget for your area of responsibility? Dr. Acheson. Within foods, it is about $400 million, I believe. I certainly can get you the exact number. Mr. Whitfield. Four hundred million dollars? That doesn't really seem like very much. And what is the total FDA budget? Do you all know that? Dr. Acheson. It is about a billion dollars, the total FDA budget. Two billion. I'm sorry. I'm not familiar with these numbers. We can get them to you for the record. Mr. Whitfield. Let me ask you another question. In February 2006, the FDA had information in hand that other foreign countries, particularly Canada and South Korea, had banned the import of Chinese eel because of the presence of malachite green. Now, that was in February 2006. FDA did not issue an import alert on Chinese eels until around November 2006, some 6, 7, 8 months later. Why did it take so long for FDA to issue an import alert in that situation? Dr. Acheson. Again, I have colleagues who can speak more to the specifics of an import alert, But let me try to summarize. In order to issue an import alert, we have to have the data to show that we can do it, which essentially means demonstrating through a sampling strategy that there is a level of contamination in a certain product of concern, in this case eel, with a certain agent, malachite green, that is of sufficient degree to pose a problem and of sufficient extent to issue a countrywide alert. What we've done when we see problems with individual companies is we can issue an alert very quickly. We did that with melamine. Two companies were of concern. The import alert for melamine, for protein concentrates was issued in a matter of weeks in that situation. But the malachite green required more testing to get to the point where we could say this is a countrywide issue, it is not just one or two firms that are causing the problem. Ms. Glavin. We also had people from the Center for Food Safety in China trying to gather that information and trying to get information and data on the extent of the problem, which helped us in putting that import alert out. Mr. Whitfield. Let me just ask one other question. My time has expired. But why do you refuse to acknowledge China's certificate of export? Dr. Acheson. It is not that we're refusing to acknowledge it. My point is that we cannot require it as a condition of entry into the United States. Mr. Whitfield. So legally you cannot require it? Dr. Acheson. Legally we cannot say that that is a requirement and without it we would refuse entry. Mr. Whitfield. Thank you. Mr. Stupak. Mr. Melancon with questions. Mr. Melancon. Thank you, Mr. Chairman. Ms. Glavin, you talked about high-risk food shipments. I guess focusing on that, what is a high-risk food shipment? Does somebody have to be critically ill or die? Ms. Glavin. There are a large variety of factors. If we're talking about food safety, the factors would be things such as what is the food. Certain foods are inherently more risky than others. Where is it coming from? Is it coming from a country where we have a history of problems? Is it coming from a manufacturer where we have a history of problems? Do we have any data that shows that there are illnesses connected with that product? So there are a variety of things that--it is not a single piece of information. A number of you have mentioned a new system that we're piloting at one port right now, and that is the PREDICT system, a system that is designed to take the real-time information we have and make--help us make decisions in real time about what we should look at and what we can let go through without a physical examination. Mr. Melancon. You talked about the Department had different authorities, some that may be new, some that you're using. How many times has the Department implemented any of these authorities in recent times? Ms. Glavin. I'm sorry. Mr. Melancon. When you were doing your testimony, you talked about these different authorities that the Department had. And I'd have to go back. Both of them were acronyms. Ms. Glavin. I'm sorry. I do use acronyms. I apologize. There are two issues with respect to food. There are two different kinds of things that we do. The first one is unique to food, and that is we look for--we have a specific responsibility to look for evidence of bioterrorism, intentional adulteration or tampering of food. And that is done in conjunction with CBP. It is done on all food coming into the country. All food coming into the country has to note--we have to be notified before it can enter the country so that we can do that screen. The second screen is our food safety screen, and that is where we look for food safety problems and look--that is the second set of criteria that are used that are specific to safety, not to the security side. And that would include things like the type of food, where it is sourced, what the company history is, what the history of that importer is, et cetera. Mr. Melancon. When you get a product that comes in that has no certificate, shouldn't that be a flag that we ought to be testing that food immediately? Ms. Glavin. Not all countries have certificates. But if a country offers a certificate, we certainly can consider the lack of the certificate if a certificate is available as one of the factors. What Dr. Acheson was saying is that we can't use the lack of a certificate as the sole reason for denying admission. Mr. Melancon. Why can't we require a certificate on all food products? Ms. Glavin. We don't have that authority. Mr. Melancon. USDA, you have the authority. Dr. Raymond. The Federal Meat Inspection Act and the Poultry Products Inspection Act gives us the authority and requires us to determine if the country has the equivalent food safety system. Mr. Melancon. So I guess the question is, has anybody ever asked for that authority over at FDA? Ms. Glavin. I'm not aware that they have. Mr. Melancon. We know we have got a problem, and nobody wants to say, maybe you all need to help us give us the tools. Dr. Acheson. Let me respond to that. We certainly recognize that we've got challenges. And I have acknowledged in my testimony that part of the Food Protection Plan that we're developing is to address those very challenges that we're discussing today. Mr. Melancon. The large quantities of commodities that come in--and, of course, maybe it is easier or harder. I'm not sure. USDA has the ability--maybe FDA needs to be talking to them about how to monitor this stuff and get it done. And somebody needs to say to the Congress, look, we've got a problem, food safety and other issues that are coming in that are creating problems. And in this day and time, I find it difficult, especially after I've been through 2 years of excuses from FEMA and other agencies about why they haven't done anything. As a member of the bureaucracy that is supposed to be trying to protect America, tell us what we need to do. Don't come here and give me an excuse why we can't do it. I can find excuses not to do it. FEMA has got a great agency for telling me how to do that. So where I am, and I think where we're trying to come from, is I don't want to continue to see food products coming into this country--and I've said this on many occasions, we've got the dumbest system in the world for negotiating trade deals. It is give them anything they ask for, don't check what comes in, and just go about your business. And it is not a good system. One person negotiates the deal, and then nobody is back here to follow it up. Shouldn't you be talking with the USTR and saying, we need food safety, we need country of origin, we need labeling, we need certification? If we're going to protect Americans, shouldn't you as the protectorate of the food supply be asking for that authority or that in those trade deals or that of this Congress? Dr. Acheson. Again, I find I'm repeating myself. I agree with everything you're saying. Our mission is to protect the public health at FDA. That's what we're about. And part of my job is regards to food safety and food defense. That is critical. The plan that I keep mentioning is through getting into the throes of clearance, and I would look forward to bringing that to this committee or to you personally and saying here is where we think we need to go, and let's have a dialog and establish a partnership in terms of whether the feeling is that this meets the needs. We recognize that we have got challenges. We recognize that we need to make changes, we need a new approach. And that is exactly what we're working on. We're just not quite to the point yet where this is out for public viewing. Mr. Melancon. My time has run out. Mr. Stupak. Thank you, Mr. Melancon. Mr. Burgess for questions, please. Mr. Burgess. Thank you, Mr. Chairman. Dr. Acheson, thank you for being with us today. Dr. Raymond testified earlier--his written testimony has a much more eloquent definition of equivalence than I used when I spoke a little earlier. Why doesn't the FDA have a similar program of that equivalence concept that the USDA uses? Dr. Acheson. There are two answers to that at least, if not more. Mr. Burgess. Give me the short answer. And I'm actually going to submit this for a written response because I think it deserves a written response. Let me just ask you to please make that timely. We've been working with--and make no mistake, I love the FDA, I love everything you do, but you guys are slow when it comes to getting responses. So give me the short answer on equivalence and then I really would appreciate a much longer written response. Dr. Acheson. The short answer is authority and complexity. Mr. Burgess. The authority being you don't have the authority, and you need us to give you the authority legislatively. Dr. Acheson. We don't have the same authority that USDA has. Mr. Burgess. You need that from us in legislation; is that correct? Are you asking us for that authority? Dr. Acheson. I'm not asking you for that authority. I'm answering your question as to why do we not have it. Mr. Burgess. I think it would be a good idea if you had it. So if I want you to have it, then we need to write you the legislation that gives you the authority to have it. Dr. Acheson. I think that leads into my second answer, which is complexity. Mr. Burgess. Before we get into complexity, let me just ask the other question. Would you use it if we gave it to you? Dr. Acheson. Within the confines of complexity, you have got to look at whether it is usable. Mr. Burgess. I was hoping to stay away from complexity for just a moment. Dr. Acheson. You can't disassociate the two. Mr. Burgess. Would you use it? Would it be a useful tool? Would it be a part of your armamentarium that you could go forward and provide the protection that Mr. Melancon so eloquently requested of your agency? Dr. Acheson. If equivalency was applied uniformly to all countries, to all products that FDA regulates, it would, frankly, be crippling. Mr. Burgess. Crippling in the fact that we would have such an enormous bureaucratic burden, we could never surmount it? Dr. Acheson. In many ways. We're talking about 200-plus countries, hundreds of products. Mr. Burgess. Is there a way to develop a program of equivalency that has the proper safeguards and parameters and boundaries so that it is not crippling, but at the same time provides a base code of safety that we can once again assure the American people that we're doing? Because they don't believe us right now. Dr. Acheson. I think with adequate resourcing of both finance and brain power---- Mr. Burgess. Fast forward. Have you reviewed the legislation that has been put forward by Chairman Dingell? Does the resourcing present in the legislation put forward by Chairman Dingell, does that provide an adequacy of resources for you? Dr. Acheson. It is more than just money. To sort out all of these issues of complexity--and I apologize that I keep coming back to that---- Mr. Burgess. That's where I want your written response because I know that is important. Dr. Acheson. That's where it gets complex, because we're not just talking about meat, poultry and egg products. We're talking about hundreds of different regulated commodities with many, many different standards in different countries, and developing that level of equivalency would be unbelievably complicated. Mr. Burgess. Again, I do look forward to a timely written response. We'll phrase that as a written question. Mr. Chairman, I really do want to see the response to that because I think it has to be part of our discussion when we craft this legislation. Let me just ask you with the little time I have left, were you astounded by the response that if someone is up there checking for their own product in another country, and they find something really bad, they don't feel obligated to disclose that to any of the regulatory agencies that are also charged with protecting food safety? Dr. Acheson. As a person who spent many years in clinical practice as a physician, it worries me that there may be problems out there that we can perhaps do something about and don't hear about it. That is a business decision. Is not a requirement. Mr. Burgess. A business decision to be sure, but do you have--with your regulatory authority, do you have the ability to go in and assess the quality-control measures that are being used by a private company that is then importing to the United States? Whether it be an American or foreign company, can you go in and look at their quality assurance methods to make sure they're up to snuff? We talked about the statistical tests before. Do you have the authority to do that? And if so, would you find such a problem with the analysis of just the quality assurance, or do you need another method of getting that information? Ms. Glavin. With respect to food, sir, we do not have the authority to mandate an inspection of a foreign firm if they choose not to have us come. Mr. Burgess. I don't mean to interrupt, But I'm just astounded by that. So if a private company that is importing poultry to this country says, whoa, on this shipment we have got polonium under the chicken wings, we're not going to bring it in, but we just don't say anything about it? Ms. Glavin. Well, poultry is under the USDA, but if it was peaches, yes. Mr. Burgess. If it was whatever, shellfish or whatever, if you found a problem to that order or magnitude, which to me means bioterrorism, would you not have authority under the Bioterrorism Act to require that information be given to you? Ms. Glavin. If we had information, absolutely. Mr. Burgess. But if they have information, and they just choose not to tell you as a business decision because they don't want to irritate the People's Republic of China, that is OK? Ms. Glavin. I'm not saying it is OK. I'm saying that we don't have the authority to mandate that they give it to us. Mr. Burgess. And that would be the situation, that if they said, well, we just don't want to irritate our host, so we're not going to give you that information, that is what would happen? Ms. Glavin. That's right. Mr. Burgess. So as we sit up here on this dais attempting to assure the American people we're providing oversight, we've really got no mechanism to go back and check that; is that correct? This gets back to Mr. Melancon's questions about the trade agreements. And I realize it is out of the purview of this committee and this argument, but clearly that seems to me that is a gaping hole that has got to be closed. Or am I missing something? Dr. Acheson. I think in the context of foreign companies, you're correct. And as Ms. Glavin has pointed out, we don't have the authority to do that. Mr. Burgess. Do you agree that that is a potential liability for us, a potential vulnerability for us? Dr. Acheson. It is one of the areas that we're considering in the Food Protection Plan is what do we need to do to address those kinds of gaps. Mr. Burgess. I'm not one that normally eats Chinese eels, and I don't intend to ever begin, but just the whole story with the malachite green stuff is a little disturbing, that you found the problem and it took so long to control the problem. What if it were something much more serious? When I say serious, i.e., involving a food that I might eat. Dr. Acheson. If it was food you were eating, we'd be right on it, I can assure you. No. A serious point. We did react very quickly when we had issues with melamine. That was in a matter of days or weeks once we knew there was a problem. Mr. Burgess. And I'd submit that I don't know that we really know when that problem began. I have just uncorroborated testimony from veterinarians back in my district, boy, we were losing a lot of pets, and we didn't know why. And that worries me because I don't--again, I don't--and then it comes back to the point that if someone knew that we're grinding up countertops and putting them in our dog food, they've got to tell you that so you know to look for it. Somewhere along the line there has to be some responsibility of the companies that are providing imports into this country or they lose their license, I think. Just my opinion. Mr. Chairman, I yield back. I know I've gone over. Mr. Stupak. Thank you. And I'm sure we'll go another round or two at least with this panel. You mentioned melamine. That was Customs and Border Patrol that stopped melamine. It wasn't FDA. Dr. Acheson. No, it was FDA which issued the---- Mr. Stupak. We had a hearing. It was Customs and Border Patrol that was stopping melamine before the FDA ever got around to it. Even after the FDA got around to it, it took your lab, like, 48 hours to discover the melamine because it didn't know what it was looking for, right? Dr. Acheson. I beg to differ. It was FDA labs who identified that it was indeed melamine. And then it was FDA---- Mr. Stupak. That was the lab---- Dr. Acheson. And then it was FDA that set up the import alert. We then worked with Customs and Border Protection to put that into practice. Mr. Stupak. When is this plan going to be done? You keep talking about this plan you want. When is it going to be done? Dr. Acheson. As soon as possible. Mr. Stupak. That means what? Dr. Acheson. I would anticipate--and as I've said earlier, it is within high levels of clearance within our Department right now, within HHS. Mr. Stupak. When do you anticipate it is going to be done? Dr. Acheson. I hope within the next 2 to 3 weeks we'll be able to get this out. Mr. Stupak. And are you going to ask for an equivalency standard like the USDA has in this plan? Dr. Acheson. The specifics of that plan are still under discussion with our Department. I can't get into the specifics of what may be---- Mr. Stupak. Why can't you get into the specifics of it? Dr. Acheson. Simply because it has not been cleared by my administration. Mr. Stupak. Who is the administration, the White House or HHS? Dr. Acheson. It is both. Mr. Stupak. So you're getting pressure from the White House and HHS to do certain things in this---- Dr. Acheson. I didn't say we were getting pressure. Mr. Stupak. No, I did. Dr. Acheson. No, I'm not getting pressure. There is a required process of clearance, and it is just not completed. Mr. Stupak. Does the FDA require additional legislative authority to apply HACCP requirements to all domestic food producers, processors like we have for juice and seafood. Dr. Acheson. As you have just acknowledged, we have put out HACCP requirements for two products, for juice and seafood. Mr. Stupak. Right. So you require further legislative authority to do all domestic food producers and processors is my question. Do you require additional authority, or can you do it underneath the existing HACCP authority since you've done it for juice and seafood? Dr. Acheson. I'd have to seek a legal answer to that. I'm not an attorney, but my understanding of that is if we've done it for two, we could potentially do it for more using that same approach. Mr. Stupak. Sure. So why wouldn't you do that then, use those requirements to make American consumers safer? You did it for juice and seafood. Why not do it for the rest? Dr. Acheson. As I said, I believe that we do need to be seriously looking at putting in preventive controls, and using a HACCP-type approach is potentially a way to do that. Mr. Stupak. You indicated to Mr. Burgess that you needed more resources. We indicated that the Dingell-Pallone-Stupak bill which is currently pending, which would generate $500 or almost up to $600 million a year for food. Would that be adequate resources. Dr. Acheson. It would certainly help. Mr. Stupak. But would it be adequate? Dr. Acheson. Adequate to do what? Mr. Stupak. To provide food safety, to inspect the 99 percent we're not inspecting. Dr. Acheson. No. If the goal is to inspect 100 percent---- Mr. Stupak. The goal isn't 100 percent. Or is that going to be the goal of your plan, 100 percent? Dr. Acheson. No. Mr. Stupak. Is there a percentage your plan indicates? Dr. Acheson. No. Simply throwing more money at this to do more inspections is not a solution. Mr. Stupak. I agree. Dr. Acheson. What we've got to do is do smart inspections, and that means the risk--and it gets back to your earlier point---- Mr. Stupak. Let's go back to the Dingell legislation. Has the FDA taken a position on the Dingell legislation? Dr. Acheson. Not that I'm aware of. Mr. Stupak. Has the FDA taken any position on any of the bills that have been introduced for the last 10 years on food safety? Have you taken any positions on them. Dr. Acheson. I'd have to get back to you on what the official positions are on any of those previous bills that predate my time in this position. Mr. Stupak. Ms. Glavin, do you know? Ms. Glavin. I don't know. Sorry. Mr. Stupak. I can tell you I wrote the first one in 1998. We're still waiting for an answer. So I hope your plan is not going to be 10 years. Let me ask you this: What specific requests have you made in terms of resources from the Commissioner or Office of Management and Budget? Have you made requests to them for more money for resources, for inspections, for overseas work? Dr. Acheson. We've made requests through the 2008 budget process for an increase---- Mr. Stupak. And how much was that increase? Dr. Acheson. I think it was about $10 million or thereabouts. Mr. Stupak. What was the $10 million going to be targeted for? Hopefully not bonuses. Dr. Acheson. I know a portion of it was for research, some for foreign inspections. Again, for the record, I could get back to you the breakdown exactly of what the 2008 budget request was. Mr. Stupak. Let me ask you this: Do you support recall authority to be given to the FDA, Dr. Acheson? Dr. Acheson. We've managed for years without it, and I believe we have an effective system. It is certainly one more tool in the toolbox that could potentially be used in certain situations. Mr. Stupak. Do you support recall authority for the FDA? Dr. Acheson. Are you asking me personally? Mr. Stupak. I'm asking you, first of all, as a drug czar. Dr. Acheson. Food czar. Mr. Stupak. Food czar. We'll get to drugs next week, November 1. Dr. Acheson. As I've said, I believe that it could be a tool in the toolbox that could under certain situations expedite recalls. Since I've been working at FDA in this role for---- Mr. Stupak. What do you want? Do you want only recall authority for certain types of food or what? I mean, why would you be opposed to a recall authority? Dr. Acheson. I'm not opposed to it. Mr. Stupak. You are saying only under certain circumstances. You've got to have the authority before you can use it. Just because you have the authority doesn't mean you'll use it. So you'll use it where you want. You can't use it if you don't have it. Dr. Acheson. I'm not opposed to us having that authority at all. Mr. Stupak. Good. Let me ask you this: You said that your group is looking at--in proactive, risk-based and rapid response, correct? Dr. Acheson. Right. Mr. Stupak. Proactive, explain that. In what way are you going to be proactive? Dr. Acheson. That is getting back to the prevention issue. What we've got to do is build safety in right up front with the manufacturer, at the processor, so that what is being done at the manufacturing level is building preventative controls up front as opposed to reacting to them when we get illness. Mr. Stupak. Sure. I agree with that. So let's go back to certification, let's say like in China, the farms and plants or food processing place. If that is going to be proactive--and even the President is fond of saying we have to fight terrorism overseas so we don't have to fight them on our own shores. So why don't we have that same attitude when we have to fight food safety issues instead of waiting for it to arrive in America? How come we're not being proactive in taking it overseas; instead we allow 99 percent of the food to come in without ever being inspected. Dr. Acheson. That's exactly what we're proposing to do. Mr. Stupak. How---- Dr. Acheson. What you're alluding to is pushing the borders out. What we're trying to get away from is this snapshot of the port of entry where we make a determination based on the information that we receive. Mr. Stupak. How are you going to get it overseas? How are you going to be proactive overseas? Are you going to assign inspectors overseas in countries? Dr. Acheson. There is a number of avenues that we can take. One is to have a greater foreign presence physically from FDA. Mr. Stupak. Is that one you recommend? Dr. Acheson. It is certainly one of the possibilities that we're looking at. Second is to develop memorandums of agreement with foreign governments and to work with foreign governments and, as part of that, to get a better insight into the processes and standards that are occurring in foreign countries, particularly in the foreign countries that we have concern about with regards to food safety. And then the second part is working with the industry in terms of working with them to look at their processes, their data in terms of what they're doing in foreign countries to help determine relative risk of a product coming into the United States. Mr. Stupak. All right. My time is up. Mr. Whitfield for questions. Mr. Whitfield. Just one other question I wanted to ask Dr. Raymond. Dr. Raymond, the Food and Drug Administration has a list of--in their regulations--they have a list of drugs. And they say if one of these drugs is present in an animal that is to be slaughtered for human consumption, then it is disallowed. At a time when they were slaughtering horses in the U.S., even though that meat was being exported to other countries, about four of the listed drugs were specifically used by--in animals that were used in horse racing. And it was a common drug, and a significant number of these horses that were slaughtered were racehorses. How do you ensure that those drugs are not present when the animal is slaughtered? Dr. Raymond. Part of our regular testing is testing for residues. I don't know that I could answer your question that we know--we test them---- Mr. Whitfield. I was told that not every animal was tested. Dr. Raymond. That would be correct. Mr. Whitfield. That's correct. So there is a likelihood that--I mean--fortunately, it is not consumed in the U.S., but it was going to Europe and Japan. And these drugs, many of them as a matter of course are given to animals that race. So they are in there. So there is a likelihood that a lot of this meat going abroad had a prohibited substance in it, I would say. Dr. Raymond. I would think that a lot of the drugs that you're referring--I don't know the exact ones, of course, but they were probably things that were used to treat ailments like a tender knee or something like that, like an anti-inflammatory drug that may be in the system for a very short period of time. And most of the horses that would go to slaughter are horses that have long since quit racing, and they may not be taking those drugs, and they are probably not drugs that stay in the meat. Mr. Whitfield. But some of them haven't been off the track long when they're slaughtered. But you've answered the question. So thank you very much. Mr. Stupak. Let me just ask a few more questions, if I may. Ms. Glavin, you made mention of the detain without physical examination alerts, that our food products are actually delivered to the importer premises, correct? Ms. Glavin. That's right. Mr. Stupak. And isn't it also true that the importer may obtain a private lab certification that the product is not in violation. Ms. Glavin. Well, when something is detained without physical examination, it is the importer's responsibility to demonstrate that the product should be admitted and---- Mr. Stupak. The way to do that, they go to a private lab to show that the food---- Ms. Glavin. That is one way they can do it, yes, sir. Mr. Stupak. May the FDA audit the private laboratory results? Ms. Glavin. We have no regulatory authority over the labs themselves. We certainly look at the lab worksheets in determining whether or not we're going to accept those results. Mr. Stupak. So you can't even audit the lab? Ms. Glavin. No. We do some audits, but we have no regulatory authority over those labs. Mr. Stupak. Do you want regulatory authority over the labs, certify these labs that are doing the testing. Ms. Glavin. I think that would be something very interesting to look into, yes, sir. Mr. Stupak. Not interesting. Would you like that authority as part of the Dingell bill? Certification of these labs? Because there is no certification of these labs, is there? Ms. Glavin. No. Mr. Stupak. There is no FDA inspections to make sure they are doing the testing properly? Ms. Glavin. That is right. Mr. Stupak. And you have heard testimony today, and we have had it this morning, that basically if you don't get the test result you want, you dump it in the garbage can and get another test until you get the one you want. Isn't that sort of what is being said about these private labs? Ms. Glavin. I have heard that said, yes, sir. Mr. Stupak. So wouldn't it appear you would want to certify these labs to make sure that the test results are accurate before we allow this food out in the mainstream commerce? Ms. Glavin. I think that would improve the system. It would also be a resource concern. Mr. Stupak. A resource concern. You mean inspection of these labs? Ms. Glavin. Yes, sir. Mr. Stupak. And have you ever asked for any money to hire inspectors to inspect the labs or to certify labs? Ms. Glavin. I am not aware that we have ever asked for that. Mr. Stupak. Dr. Raymond, if I may, recently the USDA announced recalls of two brands of ground beef. In one of those cases, it took the USDA 18 days to recall the product after learning about its potential health hazard. Why did it take so long? Dr. Raymond. In that case we had one illness, one person. Cultures from that person's stool did grow out E. coli 0157:H7. That person had consumed frozen hamburgers from the freezer. We went and got the remaining hamburgers that were in a box that had been opened and tested, 13 tests, and two of them did turn out positive for E. coli O157:H7. At the same time we went out and obtained product that were still in enclosed, sealed boxes, so there would be no risk of having them tampered with, as is routine and normal for us. And all of those samples tested negative. So we had no rock-solid, concrete proof to say that that contamination of the young lady occurred from a product that was contaminated in the plant. And at that time, with just one case, we didn't feel we had the legal standing to go do a recall. With the recall, when it did occur 18 days later was because of other illnesses that had eaten product that had been produced prior to that product that we are talking about. So what I'm trying to say, not defensively, but a recall in 7 days after we found out would not have prevented any of the other illnesses, but it took the other illnesses to line up everything to say beyond a shadow of a doubt it came from that plant on this production date. And that is when the recall was initiated. Mr. Stupak. Does USDA have recall authority, or do you have to work with the producer? Dr. Raymond. We work with the producers. Mr. Stupak. So you don't have recall authority either? Dr. Raymond. We can seize and detain, but we cannot recall. Mr. Stupak. You indicated that on your equivalency standard, you have 33 countries that are allowed to ship food into here because they have an equivalent standard to ours? Dr. Raymond. Yes, sir. Mr. Stupak. Does the Department of Agriculture limit the number of ports in which USDA-regulated products can be brought into the country? Dr. Raymond. Mr. Chairman, we don't limit the ports, but all product has to go through one of our import houses. So it can come through a port where we don't have an import house, and it will have to be moved by truck or rail to an import house. Mr. Stupak. How many import houses do you have then? Dr. Raymond. There are about 140. Mr. Stupak. And I take it they are in close proximity to some of the main shipping ports? Dr. Raymond. They are all either at water ports or on cross-border border crossings, yes. Mr. Stupak. Ms. Glavin, how many ports does the FDA allow food to come into? Ms. Glavin. Food can come into any U.S. port. FDA-regulated food can come into any U.S. port. Mr. Stupak. Any port? Ms. Glavin. Yes, sir. Mr. Stupak. How many ports are there in the United States then? Ms. Glavin. I believe there are in excess of 300. Mr. Stupak. Do you have import houses or anything where you limit? Ms. Glavin. No, we have inspectors at approximately 90 of those ports. Mr. Stupak. So if there is 300 and some, and there is 90, so one-third at best have inspectors at? Ms. Glavin. Yes, sir. Mr. Stupak. And are they limited in what hours they can come into a port, 8:00 to 5:00, or they can come in at any time? Ms. Glavin. That is right. Mr. Stupak. Dr. Raymond, how does the USDA decide which ports of entry to designate as eligible to receive the shipments? Again, is it just because they are in close proximity to the---- Dr. Raymond. Mr. Chairman, meat and poultry products can come into any port. It cannot enter commerce until they have gone through an import house. So we do not limit the ports. The import houses are located---- Mr. Stupak. But the import houses, what happens? They come to a port, but they get to an import house. What happens in between there? Do they have to maintain them frozen? How do you maintain the integrity of the product in between the port and your import house? Dr. Raymond. Excellent question. Obviously, one of the things we do look at at the import house is to make certain that it appears that there has been no change in the integrity of the product. For instance, if it is a frozen product, and the box appears to have had moisture on it, we are going to get concerned that perhaps the integrity was not maintained. But obviously these products are going to be shipped under certain conditions, refrigerated trucks, et cetera, depending upon the product. Mr. Stupak. How often are the samples of these products collected for testing by a lab? How are often are the samples collected? Is that every box? Dr. Raymond. No, sir. A little over 10 percent of all the lots that come into this country through an import house are opened and are more intensively inspected. Probably about 50 percent of those boxes that are opened are then further tested for pathogens or residues. Mr. Stupak. So these lots that come in, you inspect 10 percent, correct? Dr. Raymond. We reinspect all lots, but we open about 10 percent of the boxes. Mr. Stupak. Who does your inspection or lab test? Do you have private labs you send this to? Dr. Raymond. No, sir, we have three laboratories that we use. Mr. Stupak. All testing is done in-house? Dr. Raymond. In USDA labs staffed by USDA personnel. Mr. Stupak. The system you use at USDA, could that be duplicated at the FDA for food? Dr. Raymond. You mean using the import houses, et cetera? Mr. Stupak. Yes. Testing with your own labs, not private labs, and---- Ms. Glavin. Are you asking me? I am sorry. Mr. Stupak. No, I am asking Dr. Raymond. Could your system be duplicated for the FDA? Dr. Raymond. I don't know that I can answer for the FDA. Perhaps portions of our system could be modeled. But I have to point out that it is our authorities that require what we do, and it is our authorities that Congress funds us to have those resources available so we can meet the authorities in the Federal Meat Inspection Act. Mr. Stupak. Your resources comes from an inspection fee; do they not? Dr. Raymond. No, sir. Congress gives us a great majority of our resources to do what we do. Mr. Stupak. Have you had to come back to Congress to ask for extra resources to do your job, USDA, to do the inspections? Dr. Raymond. We have, and we will continue to do so, I am sure. Mr. Stupak. Have you received the resources that you requested from Congress or---- Dr. Raymond. Periodically, sir. Sometimes yes, sometimes no. Mr. Stupak. Are you short of resources now? Dr. Raymond. I think we have what we need right now to do the job that we are asked to do. Mr. Stupak. Thank you. I have nothing further. Mr. Whitfield? Hearing no other Members seeking to ask questions, we will dismiss this panel. Thank you all very much for being here. That concludes our questioning. I want to thank all of our witnesses for coming today and 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 into the record. Without objection, the documents will be entered into the record. That concludes our hearing. Without objection, the meeting of the subcommittee is adjourned. [Whereupon, at 1:32 p.m., the subcommittee was adjourned.] [Material submitted for inclusion in the record follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE NATION'S FOOD SUPPLY?--PART IV DECEPTION IN LABELING ---------- TUESDAY, NOVEMBER 13, 2007 House of Representatives, Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, Washington, DC. The subcommittee met, pursuant to call, at 11:07 a.m., in room 2123, Rayburn House Office Building, Hon. Bart Stupak (chairman) presiding. Present: Representatives Schakowsky, Dingell, Whitfield, Burgess, and Blackburn. Staff present: David Nelson, Kevin Barstow, Richard Wilfong, John Sopko, Scott Schloegel, Kyle Chapman, Alan Slobodin, Peter Spencer, Krista Carpenter. 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 on ``Diminished Capacity: Can the FDA Assure the Safety and Security of our Nation's Food Supply?--Part IV--Deception in Labeling.'' Each Member will be recognized for an opening statement. I will begin. This is the fourth in a series of hearings this subcommittee has held on FDA's ability to assure the safety of our Nation's food supply. Future hearings in this series are expected to include a review of the President's newly announced plan to stiffen the inspection of food imports. Our hearing today, however, will focus on the treatment of the packaging of meat and fish in carbon monoxide. This recent innovation adopted by some members of the food processing industry is highly deceptive. Carbon monoxide artificially preserves the color of meat, making it appear fresh even after it has spoiled. For that reason, consumers cannot rely on the age-old method of looking at the appearance of meat and fish to gauge its freshness when it has been treated with carbon monoxide. Unfortunately, most consumers are unaware of this fact. Frankly, I was astonished to learn that carbon monoxide treatment provides no consumer benefit at all. Carbon monoxide does nothing to preserve the freshness of meat and fish; carbon monoxide does nothing to prolong the food's shelf life; and carbon monoxide does not make food safer; carbon monoxide does none of these things. To put it bluntly, the sole purpose of carbon monoxide packaging is to fool consumers into believing that the meat and fish they buy is fresh no matter how old it is and no matter how decayed it might be. That's because the carbon monoxide keeps the meat looking bright red. It even makes fish look better after treatment. Over the past few years, some of the largest food processors in the United States have decided to treat their meat with carbon monoxide, both Cargill and Hormel, which our tests find today treat large quantities of meat with carbon monoxide to artificially preserve its color indefinitely. Both companies will say this is not only a safe product, but a safer product because no butcher has touched it. That argument might have some weight if E. coli were not still appearing in carbon monoxide-packaged meat in Cargill and in other meat processing plants. Over the past year, there have been more than 40 meat recalls. Since October, Cargill has had two major recalls, one involving approximately 800,000 pounds of frozen ground beef, and, most recently, more than 1 million pounds of fresh ground beef. It should be pointed out that approximately 11 percent of Cargill's fresh ground beef recall comprising 119,000 pounds had been treated and packaged with carbon monoxide. That recalled meat still looked fresh, red and wholesome, but it contained the deadly E. coli bacteria. Carbon monoxide treatment also disguises rotten fish, something the FDA has known about since at least the mid-1990s. Nevertheless, that didn't stop the FDA from allowing fish importers to treat fish with so-called ``tasteless smoke,'' whose only active ingredient is carbon monoxide. Originally, the carbon monoxide was derived from smoke, but today most fish packers are using carbon monoxide from canisters rather than from the smoking process. This begs the question of whether an FDA-approved label referring to carbon monoxide as ``tasteless smoke'' isn't further deceiving consumers. The U.S. market has been flooded with fish whose color is preserved or even enhanced by carbon monoxide. The committee learned from staff visits to several U.S. ports and FDA labs that a high percentage of this carbon monoxide fish is refused entry into the United States because it is decomposing or it contains dangerous levels of histamine. The rejection rate of carbon monoxide fish at the Port of San Francisco, for example, is between 20 and 30 percent. Today we will be hearing from the president of one of the major importers of carbon monoxide-treated fish. Despite the deceptive nature of the carbon monoxide treatment and the potential health threat, the FDA and USDA have turned a blind eye to this practice. The FDA, for example, has simply ignored Federal law which requires a formal rulemaking with public input and comment for the use of food additives or coloring. Instead, the agency has granted its permission to use carbon monoxide through an odd process in which the FDA announces it has no questions about carbon monoxide's use. I'm looking forward to exploring this matter further with both the FDA and USDA witnesses today, for I and the American people have a number of questions that need to be answered. Lastly, I would note that soon after we opened this investigation, there were recent letters to a number of prominent food processors and retailers requesting information and records on the blasting of meat and seafood with carbon monoxide. In response, Tyson's Food, Safeway, Giant Food, and Stop & Shop all agreed to stop selling carbon monoxide-treated meat. In addition, Target decided to label all individual meat packages to inform the consumer the meat they are selling is treated with carbon monoxide, and to further caution the consumer that neither the color nor the ``use by'' or ``freeze by" date can be relied upon as an indicator of freshness. Perhaps we can make additional progress today. If meat and seafood companies want to blast their products with carbon monoxide to artificially enhance the color, the least they should do is label the products and warn consumers not to rely on the color, texture and apparent wholesomeness of their products. My time is up. I will next turn to the ranking member of the subcommittee, Mr. Whitfield from Kentucky, for an opening statement, please. OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY Mr. Whitfield. Chairman Stupak, thank you very much. We certainly welcome all of the witnesses today for this important hearing. Today's hearing focuses on using modified atmospheric packaging, which uses a mixture of gases, including small amounts of carbon monoxide, nitrogen, oxygen, et cetera, to maintain fresh color and to enhance the shelf life of meat products. I might add that this same technology, in addition to being used in meat, has been used in the packaging of many other products for some time like potato chips, lunch meats, bagged salads, and other products. Now, the FDA has reviewed the use of modified atmospheric packaging a number of times since the late 1990s, and on every occasion it has agreed that it can be classified as a safe way to package food. In addition, the Food Safety and Inspection Service reviewed scientific data on MAP and decided not to require labeling for atmospheric gases. Mike Doyle, who is the director of food safety at the University of Georgia, in a study said that the benefits of carbon monoxide, MAP technology, far outweigh arguments against the technique. Scientists at the University of Georgia, for example, contaminated meat samples with E. coli and packaged them using MAP. A controlled sample was also packed in traditional packaging tainted with E. coli, and when left at an environment of 50 degrees Fahrenheit, the meat packaged without MAP technology had 12 times as many E. coli cells. So you can make the argument that this packaging using carbon monoxide provides a safer product. Another study conducted by Texas Tech University found that the use of carbon monoxide in packaging dramatically decreased the growth of pathenogenics, bacteria, on meat. Of the estimated 100 million packages of carbon monoxide meat that has been sold and consumed in the United States, it's almost negligible of any problems with it. I know that Chairman Stupak and Chairman Dingell have been focused on this issue for some time and have introduced legislation, and I might say that their legislation, from my understanding, does not ban the use of this technology, but requires a more prominent labeling of its use to provide better notice for consumers. The use of this technology became an issue in the United States when a company called Calsak began an effort to ban the use of this modified technology. Calsak sells a rosemary extract that meat processors use in traditional packaging that maintains the red coloring of meat; in other words, they have a competing technology with the MAP technology. So is this issue about technology, or is this about safety? Now, we know that Japan, Singapore and Canada have banned the use of MAP packaging for tuna, and we know that the European Union has banned it for the packaging of meat and tuna. Interestingly enough, in Norway they used it for a period of 17 years with no ill effects, and I might also point out that the European Union Scientific Committee that looked at this technology concluded that there is no health concern associated with the use of 0.3 to 0.5 percent CO and a gas mixture with CO\2\ and N2 as a modified atmosphere of packaging gas for fresh meat provided that the temperature during storage and transport does not exceed a certain temperature. So even the EU Scientific Committee has said that this is not a safety issue. I look forward to the testimony today because all of us are committed to the maximum safety for the consumers in America. I might say, though, that on the second panel of witnesses, unfortunately, our staff did not have an opportunity to interview them, and normally we do have that opportunity. I would also point out that while a certain percent of seafood coming in through San Francisco--I guess 20 to 30 percent of the imported seafood--treated with carbon monoxide was decomposed, it would be helpful to know what percent coming in without carbon monoxide also had the same problem. I know that Chairman Stupak and Chairman Dingell issued a letter to all of the health departments in 50 States in the U.S. about a year ago, and it's my understanding that the health departments have replied, but we have not been given access to those studies. So I'm assuming that the replies do not indicate any safety issue from those 50 States. As I said, we look forward to this testimony on this important consumer safety issue, and I see my time has expired. Mr. Stupak. The Chair recognizes Mr. Dingell, the chairman of the full Committee on Energy and Commerce, for any opening statement, please. OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Mr. Dingell. Mr. Chairman, thank you, and thank you for holding this important hearing and also for the excellent series of safety investigations that you have conducted this year. Each of these hearings has not only helped the committee to develop legislation, but it has also increased Americans' awareness of the risks they face every day in their kitchens or neighborhood restaurants. Today we turn to the approval of carbon monoxide to disguise the true colors of fish and meat, and to the refusal to disclose to the American consumer the use of this process. This is not to say that sometimes meat and fish treated with carbon monoxide are not perfectly fine when they reach the grocery stores or even the restaurant kitchens, but it concerns us greatly that the treatment with this gas enhances colors, particularly reds, to the point where spoiled meats or fish look fresh as the day they were packaged. The regulatory agencies responsible for protecting the public health, the Food and Drug Administration--the FDA--and the U.S. Department of Agriculture--have permitted this potentially deceptive practice in the United States even though Canada, Europe and Japan all ban it. In doing so, the FDA and USDA have also refused to require the companies to label their products as treated with carbon monoxide, something that every consumer should know before a purchase. One of the key factors for consumers in selecting meat or fish is its color, followed by its smell. We have a nice example of meat down on the hearing table. Some of the meat is a year old. I suspect that it is spoiled, although you can't tell so by the color. You probably can't tell by the smell since the packaging is totally sealed, although I suspect that, if the packaging were open, we might find that the contents are not as nice as they look. Finally, you can't tell by the labeling because the companies have apparently convinced the regulators that consumers might be confused or frightened if they knew they were eating foods which were treated with carbon monoxide. They also might know that the food is packaged in a way which conceals the smell while the color looks good. One of our USDA witnesses says that the packaging, if it is not bulging, is fine. Committee staff have actually been told by a Hormel scientist that the worst thing that can happen even if a food product is spoiled is that the consumer might have a ``unpleasant dining experience.'' They argue that the spoiled meat won't hurt us. The bacteria that cause the meat to spoil are not pathogens. Let's test these arguments. I think they are false. We all know that Cargill, in particular, should know that meat packed in CO can also contain pathogens that can kill or harm us. Last week Cargill recalled more than 1 million pounds of ground beef suspected of containing the dangerous E. coli germ. Of that amount, some 119,000 pounds were treated with carbon monoxide and, therefore, would look as fresh and as pleasant as the day they were butchered until some unsuspecting customer purchased it. Mr. Chairman, I urge you to get to the bottom of how and why these decisions were made by FDA and USDA. I also urge you to lead us to find why the companies still refuse to let the American people know that their meat or fish is being treated with carbon monoxide. I commend you for your leadership, Mr. Chairman, in this matter and that you are helping us to understand that here we have a problem which may need a legislative fix or which will require, perhaps, an unpleasant experience by the FDA before this subcommittee, which is so ably chaired by you. Mr. Chairman, again, thank you for holding this hearing. It is important, and it is important to the safety of the Nation's food supply. I look forward to the testimony of the witnesses today and particularly the response to our questions from both the FDA and USDA. Mr. Chairman, this committee has a proud record of working to protect the consumers, and I am sure, under your leadership, we will continue to fight for a strong food safety system in this country. Today I hope we will move one step closer to making this necessity a reality. Thank you, Mr. Chairman. I yield back the balance of my time. Mr. Stupak. I thank the gentleman. Mrs. Blackburn for an opening statement, please. OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE Mrs. Blackburn. Thank you, Mr. Chairman. I thank you for the hearing that today we are going to use to examine the issue of carbon monoxide technology used in meat packaging, which provides protection against food-borne bacteria and the extended shelf life for fresh meat products. Unfortunately, this technology is being called into question over supposed safety concerns of the packaging format. Modified atmospheric packaging has been used for over 75 years, Mr. Chairman, to prolong shelf life and to maintain color freshness. Despite situational arguments to the contrary, no conclusive evidence has been presented that links this packaging and this process to increased food-borne illness and/ or death. The decomposition of meat products, spoilage alone, does not correlate to food-borne illness such as E. coli, and if anyone has ever had a food science class, in fact, they will know that contamination and spoilage are two very distinct issues. They are different issues. According to the University of Minnesota's Center for Infectious Disease Research and Policy, and I'm quoting from them, ``There is a major public health difference between food contaminated with pathogens not detectable to human senses and that of spoiled food characterized by changes in food color, taste and texture in such ways as to make consumption unacceptable,'' end quote. No packaging format creates E. coli or other food-borne bacteria. Instead, packaging is a marketing tool used to manage consumer expectations. If regulation eliminates the use of carbon monoxide packaging, the result will be increased meat handling, leaks and a lack of tamper-resistant packaging, which means there will be more human interaction with the product from the time it is packaged until it moves to its final destination with the consumer. The result would likely lower the quality of meat provided to consumers and would increase the potential for bacteria. This is clearly a step in the wrong direction. Mr. Chairman, let's give consumers some credit. People eat with their eyes. If they don't trust their eyes, they surely know that they can trust their noses when confronted with rancid meat. In addition to smell, other obvious signs of spoilage exist. Consumer studies have shown that people rely on the ``sell by'' date, the smell and the color when determining if meat is fit for consumption. Those advancing the argument that this carbon monoxide is bad science for meat are misleading the public. There is no need for the Federal Government to implement overzealous regulation that will likely take a step backward and away from safe and efficient meat packaging. Such regulation might open the door for the increased opportunity for further contamination. How many experts have to say that the use of carbon monoxide in meat packaging is not a food safety issue before we believe them? This hearing has nothing to do with food-borne illness. Not one case of human illness has been reported due to the consumption of spoiled food, so the case for public health risk cannot be made. I hope that we are not participating in a kangaroo court due to certain economic interests and an intra-industry fight. I hope that we will continue to put our focus on food safety issues that have come before us that need our attention, and that we will not participate in a fight under the guise of food and consumer safety. Thank you, Mr. Chairman, for the hearing, and I yield back my time. Mr. Stupak. Ms. Schakowsky for an opening statement, please, for 5 minutes. OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS Ms. Schakowsky. Thank you, Mr. Chairman. I appreciate your holding this hearing today on deceptive labeling in meat packaging. As someone who began my career in consumer advocacy by leading a housewives' campaign in 1969 to put freshness dates on food products sold in the supermarkets, this issue is one I care deeply about. It was a package labeled as skirt steak, I think, of a questionable color that led me to ask the butcher at that time in my local supermarket how old the meat was, and I was shocked by his response. He said, ``Look, lady, it's fresh, and if you don't like it, you can shop somewhere else.'' That really launched my campaign with a number of my women friends to seek dates on food, expiration dates. Consumers expect and deserve as much information as possible about the food they consume even when it comes to questionable packaging practices such as using carbon monoxide to keep meats looking fresh. Some may argue that because carbon monoxide is only used in the packaging, it is not a direct ingredient or a component of the food product, and that, therefore, it doesn't need to be labeled, but when carbon monoxide has the same impact on meat products as red dye or other color additives, this is important information that consumers want to have. It's no surprise, then, that, according to a recent Consumer Federation of America poll, 78 percent of consumers said that the unlabeled use of carbon monoxide in meat packaging is deceptive, and 68 percent of consumers said they would support a law requiring the mandatory labeling of carbon monoxide. The city of Chicago, part of which I have the honor of representing, held hearings on this issue in 2006. At that time I joined with several of my colleagues in sending a letter to the Illinois Department of Public Health, asking that the agency prohibit the sale of meat and fish products treated with carbon monoxide in Illinois. Businesses are taking notice. Already several major retail stores, such as Safeway and Giant, have announced they will stop selling the product, and Tyson's recently phased out the system in their packaging. Make no mistake. The practice of treating meat and fish with carbon monoxide gives the product virtually an indefinite red color regardless of the temperature or the storage conditions. Given the fact that the EU, Canada and Japan have all banned the practice due to its misleading nature, I look forward to hearing an explanation from the USDA and from the FDA as to their rationale for approving this practice without at least a labeling requirement. I am also looking forward to hearing from Nancy Donley, a good friend of mine, who started Safe Tables Our Priority, or S.T.O.P., a Chicago-based organization with a long track record of fighting food-borne illness and raising consumer awareness of important food safety issues that she started after a tragedy affecting her son. Finally, I want to make sure we think about how this packaging process impacts the elderly and the disabled who may have impaired vision, reduced senses of smell and weakened immune systems. Freshness dates can be difficult to read, and changes in odor brought on by spoilage may not be apparent in the early stages. The bright red color of a meat product may be a key element in their purchasing decision, and I worry about their being misled or, even worse, their purchasing a product that will make them ill. Mr. Chairman, on the subject of deceptive food labeling, I also look forward to the committee's looking into deceptive practices in labeling chicken infused with salt water as all natural. This practice makes the chicken heavier, and it raises the sodium content substantially, and it has led to consumers spending an additional $2 billion annually on chicken infused with salt water. I thank you, Mr. Chairman. With that, I yield back. Mr. Stupak. Thank you. Mr. Burgess for an opening statement, please. OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Burgess. Thank you, Mr. Chairman. As always, I appreciate your holding this series of hearings on the Food and Drug Administration's ability to assure the safety and security of the Nation's food supply. Throughout the hearings I feel that we have been able to shed some light on some real problems affecting our food supply here in this country. I also think we've been able to identify, perhaps, some real solutions. It has become apparent that our Federal agencies that are tasked with helping keep Americans safe from harmful foods and harmful products are using 19th or 20th century tools when dealing with a 21st century problem. However, the Food and Drug Administration does not shoulder all of the blame in this situation. Somehow Congress failed to intuit and to recognize the rapid change that was going to be incurred by globalization, by living in a global village. There are multiple points to which we can affix responsibility, but it would be sheer fantasy to believe that Congress does not own its own share of the responsibility. Although the change that we can attribute to globalization did not happen quickly, it did not happen overnight. It is now up to Congress to absolve itself for not maintaining situational awareness. I believe that Congress does need to step up and give the Food and Drug Administration the resources and authorities they need to keep Americans safe. This series of hearings on the Food and Drug Administration's ability to assure the safety and security of the Nation's food supply will help us do just that. For instance, during a hearing this summer, we learned that the Food and Drug Administration lacks the ability and the explicit authority to immediately stop dangerous food and products from coming into this country. For that reason I introduced H.R. 3967, the Imported Food Safety Improvement Act of 2007, to stop countries from sending harmful food and products into the United States. H.R. 3967 will allow us to finally take control of the food that is being sent to America. It will also send a strong message to countries that in the past have allowed harmful products entry into our stream of commerce. So, when it comes to food safety, I feel just as strongly as many of us profess to feel about terrorism on a broader scale. We need to say to other countries, ``You're either with us or against us. Solve the problem on your end, or we'll take measures to solve the problem on ours.'' A review of the hearing timeline clearly shows that this legislation came about through a series of important hearings. I continue to believe in the mission we are trying to accomplish today; however, while I realize that today we are only focusing on one single form of food technology, that is the use of low oxygen in meat packing, I do wish we would have observed adherence to the original plan of holding a hearing that focused on a variety of technologies aiming at keeping our food safe. Considering the enormity of the problems we are facing in food safety, I have found the scope of today's hearing to be very narrow in its focus. In fact, it's so narrow that it limits the utility of what we should be about. Today's hearing involves a controversy about the use of carbon monoxide in modified atmospheric packaging in meat. Fair enough. Industry is responding to demands and is moving much faster than Congress can in this regard, and the controversy is rapidly being addressed by the efforts in the marketplace and, to some degree, in response to letters from the majority. I do appreciate the efforts of the majority's detailing this to the principal players of the industry. I would be very interested to know if the changes being contemplated in the industry are as a result of rigorous scientific investigation. I hope they are not merely a capitulation to the demands of the majority and of their staff. The majority can be commended for making this a disappearing oversight problem if what they did were to shine a bright light on a real problem; but, again, I do wonder, Mr. Chairman, if we have this response as a result of rigorous scientific investigation and sound science. Mr. Chairman, very briefly, we have heard from the majority staff about a trip they took to China. I took a trip to China in 1993 with the Association of Aerospace Physicians. Let me tell you, I gained a new appreciation for modern American packaging and cellophane during that trip. One afternoon I took a side trip and walked through what was the equivalent of the Beijing Safeway. It was there I learned that modern American innovation was, indeed, a wonderful thing. In China, they had meat out in the open. Well, let's be honest. They had live snakes in bins, and you don't normally see those in a Safeway even here in DC, but they had meat out in the open with no covering, rendering it pretty unappetizing because of the smell, the sight of flies and the overall color. So flies, discoloration and olfactory assaults were such to make even the most ravenous of appetites vanish. Mr. Chairman, if you are correct about the use of low oxygen being deceptive, then you are to be commended for making this a disappearing oversight problem; however, I would also like to commend Hormel for trying to make their product better by finding a way to address the issue of long-term color change through new interventions. In Mr. Ettinger's testimony, he mentions that his company has filed a patent on this new technology, so I look forward to hearing more about the technology and how it may remove some of the concerns that the use of the carbon monoxide may be deceptive. I also look forward to the discussion with the Food and Drug Administration regarding the ``generally recognized as safe'' determination. I recognize that the majority leadership of this subcommittee is concerned that this process does not include a review or a comment period. I would just briefly point out that it was not during this administration, but during the previous administration that this decision was made. Apparently the Clinton administration did not have a problem that there was no review or comment period allowed. Again, Mr. Chairman, thank you for holding the hearing. I hope we will be able to hold hearings on a broader array of topics within the entire context of food safety. I yield back the balance of my time. Mr. Stupak. That concludes the opening statements by members of the subcommittee. Our first panel is before us. On our first panel, we have Mr. Daniel Engeljohn. He is the Deputy Assistant Administrator of the Office of Policy, Program and Employee Development, Food Safety and Inspection Service, the U.S. Department of Agriculture. He is accompanied by Dr. Robert Post, the Deputy Director of the USDA's Center for Nutrition Policy and Promotion. We have Dr. David Acheson, the Assistant Commissioner for Food Protection at the FDA. He is accompanied by Mr. Lane Highbarger, the Consumer Safety Officer for the FDA's Division of Biotechnology and GRAS Notice Review in the Center for Food Additive Safety and Applied Nutrition; Mr. Philip Spiller, the Senior Advisor for Special Projects in the FDA's Center for Food Safety and Applied Nutrition; Mr. Donald Kraemer, the Deputy Director of the Office of Food Safety at the FDA's Center for Food Safety and Applied Nutrition. Dr. Tarantino with the Office of Food Additive Safety, the Center for Food Safety and Applied Nutrition, Food and Drug Administration. So, Dr. Tarantino, thank you for being here. It's 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 wish to be advised by counsel? Everyone is shaking their heads ``no,'' so I'll take that as a ``no.'' Therefore, I'm going to ask you to rise and to raise your right hands to take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect the witnesses replied in the affirmative. You are now under oath. We will now hear a 5-minute opening statement from our first panel. You may submit a longer statement for its inclusion in the hearing record. Dr. Engeljohn, if you'd like to start, please. TESTIMONY OF DANIEL ENGELJOHN, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF POLICY, PROGRAM AND EMPLOYEE DEVELOPMENT, FOOD SAFETY AND INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE, ACCOMPANIED BY ROBERT POST, DEPUTY DIRECTOR, CENTER FOR NUTRITION POLICY AND PROMOTION, U.S. DEPARTMENT OF AGRICULTURE; Mr. Engeljohn. Mr. Chairman and members of the committee, thank you for inviting me to appear before you today to discuss carbon monoxide in meat packaging. I am Dr. Daniel Engeljohn of the USDA's Food Safety and Inspection Service. I am a senior executive with the Department, developing food safety policy, where I have been for the last 29 years. My educational background is in animal science, food science and allied health science. I hold a Ph.D. in human nutrition with an emphasis on experimental research methods, and my work experience at the USDA has centered on risk management policies associated with the safety of meat, poultry and processed eggs. I currently serve on the National Advisory Committee on Microbiological Criteria for Foods, whereby the committee provides guidance to the USDA and to the Food and Drug Administration on food safety issues. The development in new technologies is largely initiated by industry itself as it responds to consumer demands. In 2000, FSIS and the FDA entered into a Memorandum of Understanding, allowing the simultaneous review of new technologies to increase the speed with which useful new technologies could be used. The FDA determines the safety of a food ingredient and its safe levels of use while, simultaneously, FSIS evaluates whether the ingredient has its intended technical effect. Allowing these evaluations to occur at the same time effectively decreases the time any food ingredient spends in review. Under the Federal Meat Inspection Act, FSIS is responsible for determining the efficacy and suitability for food safety ingredients and additives in meat products as well as for prescribing safe conditions for use. ``Suitability'' refers to the effectiveness of the ingredient or additive in performing the intended purpose of use, and it refers to the assurance that the conditions of use will not result in an adulterated product or one that would mislead the consumer. One form of technology used by the meat industry that has received a great deal of attention in recent months is carbon monoxide in packaging. Carbon monoxide is used to stabilize the color pigment of meat when it is red and, therefore, most appealing to consumers. The use of carbon monoxide in packaging does not impart a color to the meat; it simply maintains its naturally occurring color. Carbon monoxide does not become a part of the product and dissipates as soon as the package is opened. This is unlike other ingredients used to stabilize the red color of meat, such as citric acid, sodium ascorbate and rosemary extract, all of which actually do become a part of the product and may have a lasting effect on product color even after packaging is removed. In 2002, carbon monoxide, for use as a component of modified atmospheric packaging, was accepted by the FDA as being generally recognized as safe, or GRAS. In accordance with our Memorandum of Understanding with the FDA, the USDA in 2004 reviewed the GRAS notice submitted by Precept Foods and wrote two letters to the FDA dated April 28 and June 2, 2004, in response. It is common for FSIS to find data in original GRAS notices to be insufficient for a suitability determination and for us to notify the FDA that we consider the petition to be incomplete. The petitioners then provide additional data, which may result in our accepting the suitability of an ingredient or the acceptance with or without specific use conditions. On April 28, 2004, we sent the FDA a letter that reflected the preliminary FSIS decision based on the data we were submitted with the original GRAS notice from Precept Foods, the petitioner. As a result of the April 28 letter, the petitioner submitted additional data to address our concerns that the application of carbon monoxide may be misleading to consumers if used as described in the initial GRAS notice. The June 2, 2004, letter describes that our earlier concerns have been addressed by Precept Foods. Precept provided data evaluating shelf life, the microbiological outgrowth and the color of meat products treated and packaged using various methods, including that proposed in the original GRAS notice. These data are generally described in the third paragraph of the June 2 letter. As stated in the June response, Precept provided additional information to FSIS, addressing specific suitability concerns raised in the April 28 letter. Based on the spoilage information and use conditions provided by Precept, FSIS reversed its decision and determined that the use of carbon monoxide is suitable in modified atmospheric packaging, but only when a ``use by'' or a ``freeze by'' date is applied. ``Use by'' or ``freeze by'' dates are required on all systems in which carbon monoxide is in direct contact with meat. FSIS will continue to make its labeling decisions and its suitability reviews on the basis of the FDA's safety conclusions. Based on the data presented at the time of the letters, FSIS stands by its 2004 decision on suitability for the use of carbon monoxide in meat packaging; however, as always, FSIS would reassess the situation if new data become available. FSIS has also asked our sister agency at the USDA, the Agricultural Research Service, to conduct research related to packaging systems. Thank you for the opportunity to testify before you today. I look forward to addressing questions you might have. [The prepared statement of Mr. Engeljohn follows:] Testimony of Daniel Engeljohn Mr. Chairman and members of the committee, thank you for inviting me to appear before you today to discuss carbon monoxide (CO) in meat packaging. I am Dr. Dan Engeljohn of USDA's Food Safety and Inspection Service (FSIS). FSIS is the USDA public health regulatory agency responsible for the administration of laws and regulations that are designed to ensure that the Nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled, regardless of whether those products are sold in the United States or imported to, or exported from, the United States. FSIS is also responsible for determining that foreign meat and poultry plants operate under an inspection system equivalent to the United States before they can export to the United States. Reviewing Technology in the Meat Industry The development of new technologies is largely initiated by industry itself, as it responds to consumer demands. There are two different types of technologies that are subject to review: processing technologies and ingredient technologies. Processing technologies are those technologies developed to aid in the production of meat, poultry, and egg products. Examples of processing technologies include carcass washes, the steam vacuum, and steam pasteurization. Ingredient technologies are those technologies that involve the addition of an ingredient, generally as defined by FDA, to a product or the use of packaging to ensure safety or increase shelf life. Examples of this kind of technology include carbon monoxide packaging and irradiation. Prior to 2000, the review process for new ingredients was lengthy and cumbersome. FDA was responsible for the initial safety review. This was then followed by a review by FSIS to determine the acceptability or suitability of the technology; that is, to determine whether the ingredient served the purpose for which it was intended. In 2000, FSIS and FDA entered into a Memorandum of Understanding allowing simultaneous review of new technologies to increase the speed with which useful new food ingredients could be used. FDA determines the safety of a food ingredient and its safe levels of use, while simultaneously FSIS evaluates whether the ingredient has its intended technical effect. Allowing these evaluations to occur at the same time effectively decreases the time any food ingredient spends in review. Under the Federal Meat Inspection Act (FMIA), FSIS is responsible for determining the efficacy and suitability of food ingredients and additives in meat products as well as prescribing safe conditions of use. Suitability refers to the effectiveness of the ingredient or additive in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product or one that will mislead consumers. Carbon Monoxide in Meat Packaging One form of technology used by the meat industry that has received a great deal of attention in recent months is carbon monoxide in packaging. Carbon monoxide is used to stabilize the color pigment of meat, when it is red and, therefore, most appealing to consumers. Use of carbon monoxide in packaging does not impart a color to the meat; it simply maintains its naturally occurring color. Carbon monoxide does not become a part of the product and dissipates as soon as the package is opened. This is unlike other ingredients used to stabilize the red color of meat, such as citric acid, sodium ascorbate, and rosemary extract, all of which actually do become a part of the product and may have a lasting effect on product color even after packaging is removed. In 2002, carbon monoxide, for use as a component of modified atmosphere packaging, was accepted by FDA as being ``Generally Recognized as Safe,'' or GRAS. GRAS refers to a chemical or substance that is added to food and is exempt from regulation because its extensive use has produced no known harmful effects. GRAS notifications must be accompanied by scientific data establishing that, under the proposed conditions of use, the substance is safe, and that it will be used at the lowest levels necessary to accomplish the intended functional effects. USDA assesses suitability of use under the proposed conditions after FDA has assessed the ingredient's safety. In accordance with our Memorandum of Understanding with FDA, USDA in 2004 reviewed the GRAS notice submitted by Precept Foods, and wrote two letters to FDA, dated April 28 and June 2, 2004 in response. It is common for FSIS to find data in original GRAS Notices to be insufficient for a suitability determination and for us to notify FDA that we consider the petition to be incomplete. The petitioners then provide additional data which may result in our accepting the suitability of the ingredient or substance with or without specific use conditions. On April 28, 2004, we sent FDA a letter that reflected a preliminary FSIS decision that was based on the data that were submitted with the original GRAS Notice from Precept Foods, LLC, the petitioner. As a result of the April 28 letter, the petitioner submitted additional data to address our concern that the application of carbon monoxide may be misleading to consumers if used as described in the initial GRAS notice. The June 2, 2004 letter describes that our earlier concerns had been addressed by Precept Foods, LLC. Precept provided data evaluating shelf life, microbial outgrowth, and color of meat products treated and packaged using various methods including that proposed in the original GRAS notice. These data are generally described in the third paragraph of the June 2 letter. As stated in the June response, Precept provided additional information to FSIS addressing specific suitability concerns raised in the April 28 letter. Based on the spoilage information and use conditions provided by Precept, FSIS reversed its decision and determined that the use of carbon monoxide is suitable in modified atmosphere packaging, but only when a use-by or freeze-by date is applied. Use-by or freeze-by dates are required on all systems in which carbon monoxide is in direct contact with the meat. In November 2005, FDA received a petition asking it to withdraw its decision that carbon monoxide in meat packaging is Generally Recognized as Safe. FSIS will continue to make its labeling decisions and its suitability reviews on the basis of FDA's safety conclusions. Based on the data presented at the time, FSIS stands by its 2004 decision on the suitability of the use of carbon monoxide in meat packaging. However, as always, FSIS would reassess the situation if new data becomes available. FSIS has also asked USDA's Agricultural Research Service (ARS) to conduct research related to packaging systems. Thank you for the opportunity to testify before you today. I look forward to addressing any questions you might have. ---------- Mr. Stupak. Thank you. Dr. Post, I understand you're not going to give an opening, or are you? Mr. Post. No, I am not. Mr. Stupak. OK. Dr. Acheson, I think you're the next one to give an opening statement then. TESTIMONY OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER FOR FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY LANE HIGHBARGER, CONSUMER SAFETY OFFICER, DIVISION OF BIOTECHNOLOGY AND GRAS NOTICE REVIEW, OFFICE OF FOOD ADDITIVE SAFETY, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION Dr. Acheson. Good morning, Chairman Stupak and members of the subcommittee. I am Dr. David Acheson, the Assistant Commissioner for Food Protection for the Food and Drug Administration, and I'm joined today by my colleagues at the FDA and the USDA. The FDA appreciates the opportunity to testify this morning. To start, I'll briefly highlight the recently released Food Protection Plan and the Import Safety Plan. I will then address your concerns about the use of carbon monoxide in modified atmospheric packaging for meat and as a preservative for fish. In May 2007, the FDA was charged with developing a comprehensive and integrated food protection plan to keep the Nation's food supply safe from both unintentional and deliberate contamination. The underlying principle of the Food Protection Plan is to build in safety measures across a product's life cycle from production to consumption. Mr. Stupak. Doctor, if I may, we will have that hearing in January. So, if you want to go right to carbon monoxide, we could probably expedite it because we do have quite a few people on this panel if we're going to get right to our testimony. So, if you want to go to carbon monoxide and GRAS, we'd appreciate it. Dr. Acheson. It would be my pleasure to do that. Mr. Stupak. Thank you. Dr. Acheson. Turning now to carbon monoxide, the Food, Drug and Cosmetic Act, section 201(s) provides that a substance that is generally recognized among qualified experts as having been shown to be safe under the conditions of its intended use is excluded from the definition of a ``food additive.'' It is therefore not subject to the food additive petition process. For these substances that are generally recognized as safe, or GRAS, an interested party such as a food manufacturer may notify the FDA of its conclusion that a substance is GRAS under the intended conditions of use. The FDA reviews the GRAS notice to determine whether it provides a sufficient basis to support the party's GRAS self-determination and then responds to the notifier as to whether the agency has any questions. To show that a substance is generally recognized as safe, the proponent must show that there is a consensus of expert opinion regarding the safety of the specified use of the substance. Unanimity among experts regarding the safety of a substance is not required. During the period 2000 through 2005, the FDA responded to three GRAS notices for the use of carbon monoxide in modified atmospheric packaging systems for meat and one for notice of the use of tasteless smoke in tuna. The FDA responded by stating that the agency does not question the basis for the GRAS determinations. The FDA routinely consults with the USDA's Food Safety and Inspection Service to address our related but separate roles in the regulation of ingredients in meat, including the three GRAS notices for meat. The FDA can and does place additional limitations on the use of GRAS substances beyond those specified in the notifications. We are aware that concerns have been raised about the possible misuse of CO in seafood and the use of CO-containing MAP systems for meat. The FDA has received citizen petitions which challenge the FDA's acceptance of the GRAS status of these products. We continue to receive information submitted for consultation under the citizen petition process, and we are continuing to review and to analyze that information. In conclusion, ensuring that FDA-regulated products are safe and secure is a vital part of FDA's mission. The Food Protection Plan provides an updated approach to assure that the U.S. food supply remains one of the safest in the world, and I look forward to presenting that to you later. We look forward to working with this committee and with the Congress on implementing the Food Protection Plan and the Import Safety Plan. Thank you for the opportunity to discuss the FDA's activities to enhance food safety. I'd be happy to answer any questions. [The prepared statement of Dr. Acheson follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you, and thank you for your comments on carbon monoxide. Do any other panelists wish to give an opening statement? Hearing none, we will begin questions, and I'll begin. Dr. Acheson, you indicated that the FDA approved carbon monoxide on a GRAS, generally accepted as safe, without any questions, correct? Dr. Acheson. There was never a petition submitted for carbon monoxide specifically. It was tasteless smoke for which the GRAS notice was submitted. Mr. Stupak. OK. Did the FDA then make any approval of carbon monoxide for the use in packaging? Dr. Acheson. The FDA has not been submitted a specific petition on carbon monoxide per se. Mr. Stupak. So this is basically a USDA issue? Dr. Acheson. The FDA has no concerns about the use of carbon monoxide in modified---- Mr. Stupak. Right, but you just said that no petition was before you, so you didn't have anything on which to deal with this on carbon monoxide, correct? Dr. Acheson. There was no petition submitted. That doesn't mean that the agency didn't review the situation to determine-- -- Mr. Stupak. Did the agency review a carbon monoxide petition by Precept Foods? Dr. Acheson. The agency has reviewed the safety issue surrounding carbon monoxide. Mr. Stupak. Let me try it again. Did you review the Precept application for the use of carbon monoxide, the matter before us? Dr. Acheson. I'll ask---- Mr. Stupak. Dr. Tarantino is shaking her head ``yes.'' Ms. Tarantino. Yes, we did. Mr. Stupak. OK. Were you the person who reviewed it then? Ms. Tarantino. It was reviewed in my office, in the office I lead. Mr. Stupak. OK. Dr. Acheson said the FDA had no questions. Do you agree there are no questions? Ms. Tarantino. That was our final determination after the questions that FSIS raised and the information that we received in the final---- Mr. Stupak. OK. So that was in 2004 that you had no questions? Ms. Tarantino. That's right. Mr. Stupak. OK. Before you indicated you had no questions, your office--does the European Union allow carbon monoxide in your packaging? Ms. Tarantino. The European Union itself does not. Mr. Stupak. OK. How about Canada, does it allow? Ms. Tarantino. In meat packaging, I'm not sure. Mr. Stupak. OK. It does not. How about Japan, does it allow? Ms. Tarantino. I don't know. Mr. Stupak. With the fact that these major countries and the European Union do not allow it, did that raise a question with the FDA? Ms. Tarantino. We looked at all of the information that was in front of us, all of the information that we are aware of. Mr. Stupak. Did you specifically look at the European Union, Japan and Canada? Ms. Tarantino. We were aware of the Scientific Committee on Food, which is the risk assessors, and we were aware of the studies that had been done in Norway that supported their use of the technology for about 20 years. Mr. Stupak. Correct. Norway is part of the European Union; is it not? Therefore, they no longer use carbon monoxide, correct? Ms. Tarantino. Correct. Mr. Stupak. So they used it at one time, and now they don't. So, obviously, there were some questions there. Ms. Tarantino. Not about safety apparently. Mr. Stupak. OK. For what, consumer deception? Ms. Tarantino. I don't know. Mr. Stupak. So did you ever explore why Norway and the European Union went from using it to not using it? Ms. Tarantino. The European Union system is quite different from ours. Our understanding was that another member country or, in fact, a nonmember country petitioned the EU not to permit it in the EU, and they decided not to. Mr. Stupak. OK. Dr. Engeljohn, let me ask you this. You indicated that this Memorandum of Understanding between the FDA and the Department of Agriculture was to increase the speed on issues of food safety and packaging and issues like this, correct? Mr. Engeljohn. Yes. The MOU is to make it so that we would do a simultaneous review. Mr. Stupak. OK. In your speed to review and to approve things, where does public input come in? When does the public have a chance to comment on your review process here? Mr. Engeljohn. In the review such as the one on carbon monoxide, there was no public review process in that the issue becomes one of our providing input to the FDA about the suitability of the use, and then they make that final determination, but there is no public process on this particular issue. Mr. Stupak. OK. So there was no public input. So the only way someone could really challenge your issue is through a citizen's petition, correct? Mr. Engeljohn. Petitions are one way to do it. The agency does listen in terms of any input that we hear in terms of questions or new data becoming available for which we might re- review the issue. Mr. Stupak. In your testimony you also said that one of the purposes when you review it is not to mislead the consumer; is that correct? Mr. Engeljohn. Yes. Mr. Stupak. OK. All of the studies we've seen for the last 50 years indicate that consumers purchase their meat or seafood based on appearance; is that correct? Mr. Engeljohn. Appearance is one indicator. Mr. Stupak. OK. Has appearance been overturned as one of the indicators that citizens rely upon when they purchase their meat or seafood? Mr. Engeljohn. In this particular case, the agency did put a ``use by'' ``freeze by'' date, knowing that that, in fact, would be the best indicator as the appropriate and optimal use of this product for the consumer. Mr. Stupak. Well, tell me. How many studies show that people buy meat based on ``use by'' or ``freeze by'' dates? Mr. Engeljohn. The agency did contract for a study, which we did receive in 2002, which did identify that an overwhelming majority of consumers relies heavily upon the ``use by'' or ``sell by'' date. Mr. Stupak. Do they also rely upon color? Mr. Engeljohn. They do rely on other indicators, but the ``use by'' date is the primary mode for which they rely. Mr. Stupak. Will you submit that study to us? We've asked for those documents. You've never provided those to us. Mr. Engeljohn. We did supply that study, but we will make sure that you do have it. Mr. Stupak. OK. Turn to exhibit No. 28. It's the 33rd Reciprocal Meat Conference, 1980. The first page of that study talks about ``studies the importance of meat color that was demonstrated by Newman, et al.'' I'm on the right-hand side, at about the third paragraph. I'm at the last sentence that says, ``Certainly, consumers have few, if any, means of estimating the flavor, juiciness, tenderness of a cut of meat while it is in the showcase, so they must base their selection on visual appearance. Color, of course, is much of what the consumer bases his choice on.'' You're saying you have a study that contradicts this study? Mr. Engeljohn. We have a study that does indicate that ``use by'' dates is a predominant means by which a consumer makes that decision, but color also is one of those indicators. Mr. Stupak. Let me ask you about the--you talked about the April 28 letter. I believe Dr. Post was the author of that one. In that letter three times he mentions consumers and the deceptive practice that carbon monoxide would add if this process were approved; is that correct? That's exhibit No. 18 in your book. It's exhibit No. 18. It's an April 28 letter that, I think, Dr. Post authored in which you say, ``It is our opinion that the use of Precept Foods' MAP system that is described in the GRAS notice for use with case-ready, fresh cuts of meat and ground meat could potentially mislead consumers into believing they are purchasing a product that is fresher or of greater value than it actually is and may increase the potential for masking spoilage''; is that correct? Mr. Post. That is correct. Mr. Stupak. OK. Then the next exhibit, No. 19, is on June 2, 2004. You reversed your opinion in a letter to the FDA, stating that you no longer believe Precept's system could mislead consumers; is that correct? Mr. Post. Yes. Mr. Stupak. OK. Now, Dr. Engeljohn stated, as a result of the letter of April 28, Precept submitted additional data to address your concerns that the use of carbon monoxide could be misleading to consumers; is that correct? Mr. Post. Yes. Additional data were---- Mr. Stupak. What additional data did Precept submit to you to get you to reverse your decision? Mr. Post. Well, the April 28 letter to the FDA indicates that there was a failure in study design, and that the samples of steaks actually contained a solution, including potassium and other ingredients--potassium and sodium diacetate. The results would not be indicative of a spoilage pattern associated with whole muscle cuts of meat not containing any added substances, and those data on whole muscle cuts not containing added ingredients were needed. Also, it indicated that no samples were tested to establish a spoilage pattern for ground meat products stored under modified atmospheric packaging, and so data were needed there as well. Mr. Stupak. So did they ever submit that data to you without the antimicrobial agents so that it would not show spoilage? Mr. Post. Yes. Those data were received in May 2004. Mr. Stupak. All right. Now, Dr. Post, you are a scientist evaluating microbial growth in meats. Would you question a study where the microbial levels started high and ended up low, and where microbial counts correlated inversely with gas formation and odor scores? Would you question that as a scientist? Mr. Post. Yes, I would. Mr. Stupak. OK. Well, go to exhibit 71(e). That is the data you relied upon. If you look at 71(e), you will see that there is a question where the microbial levels started high and ended up low, and where microbial counts correlated inversely with gas formation and odor scores. Do you see that in exhibit 71(e)? It's on the last three pages. In the columns marked CT/MG, it shows a decline in all microbial counts from day 26 to day 30 and day 41. So, if anything, microbial counts should go up, not down the longer it sits, correct? Mr. Post. That is correct. However the information that we received did not show the growth of microorganisms in the shelf life of the product. Mr. Stupak. Well, this is the information right here. This is the information you received from Precept; is it not? Look at 71. It's from their attorneys. There's a two-page cover letter, then there's the whole study. I just directed you to the last three pages. I'm not a scientist, but even I figured it out that the microbial level should go up, not down, and the gas odors and formation were reversed in this study. That's true, right, in looking at those last three pages? Mr. Post. Yes. I haven't examined these thoroughly, but I'm understanding what you're saying. Mr. Stupak. Well, you would have examined them thoroughly before you approved this process, wouldn't you? Mr. Post. Yes, and we did. Mr. Stupak. Well, then, if that's the case, Dr. Highbarger, Dr. Engeljohn, any of you there, or even Dr. Acheson, you said if new evidence presented which would show that this practice isn't safe, that you would reverse your decision. So, based upon the questions here, would you not reverse your decision because the study you relied upon, to your understanding, is incorrect? Mr. Post. Well, data that were submitted in May did, in fact, sample steaks, whole muscle cuts--the kind of product data that we wanted--as well as ground beef data, and no signs of spoilage were detected in any of the samples through 41 days. Mr. Stupak. Well, that's your conclusion, but the charts show us differently on those last three pages, don't they? We just went over them. It shows it differently than your conclusion. That's the data. Let me go a little farther because Precept Foods--which is a joint venture between Cargill and Hormel, right? That's what Precept Foods is, correct? Mr. Post. I'm not aware. Mr. Stupak. OK. Go to the last 2 pages of exhibit 71(e). Because Precept also realized the data they submitted is the opposite of what you concluded, still they submitted the data. Look at the last two pages there, at the last three pages, actually. It's an e-mail, Monday, May 10, 2004. It's to Ann Waylan from it looks like, D. Rusick at Hormel.com. 71(d). Go to 71(d). OK. We're talking about this study now. Do you see this? This is the last 3 pages. It's an e-mail. Mr. Post. Yes, I found that. Mr. Stupak. OK. This is on May 10th that they submitted these documents to you. It says, ``Ann, obviously, you have had other things on your mind recently, but when you get a chance to review this report, please let me know if you see any other funny data in it. I welcome any insights or questions you may have. Quite honestly, this test seems to raise more questions than it answers. Thanks much.'' Now, that was at 3 o'clock in afternoon. If you go there, Ann Waylan responds 3 hours later: ``I've read the report a couple of times.'' This is her e-mail response back to Mr. Rusick. ``These data do bring some interesting thoughts. Why are the samples with the most off-odor have micro counts that aren't different than the samples that have acceptable odor? The sample with the last date have more desirable odor than the samples without last date. Why are micro counts decreasing as the number of days increase?'' That's the inverse that I talked about. ``Also, micro counts are decreasing, but odor is increasing.'' That's reversed. It should be just the opposite. ``When the environment has bugs, I think there would be an increase in CO\2\, but on the package tested, the CO\2\ has decreased. Just a thought. Why put a claims statement in the summary of these data that don't show results that can be patentable? Why not let the patent lawyers determine?'' Would you agree with me that that questions the validity of the study they submitted which you based your approval upon? Would you agree with me? Is that what that e-mail says? Mr. Post. Based on this information, I think this leads to some questions, yes. Mr. Stupak. Based on this information, don't you think you should reconsider your approval of the use of carbon monoxide until we get these questions answered? Mr. Post. Well, I suppose my best response is that based on the data that we received in May 2004, no signs of spoilage were detected in any of the samples. The additional data were from studies that were conducted in February 2000---- Mr. Stupak. By Precept Foods as the data submitted to you on which you based your decision upon, correct? Mr. Post. Exactly. Mr. Stupak. So the questions I raised and the questions raised in this e-mail, would you not want to reconsider it, the use of carbon monoxide in packaging? Mr. Engeljohn. This is Engeljohn on behalf of the Department FSI. So I would say as I said in my opening statement, if in fact we receive new data or information for us to reassess the information that we were previously provided, we certainly will do that. And we have in fact---- Mr. Stupak. So you'll now reassess your--based upon this e- mail, the information that I pointed out? Mr. Engeljohn. We clearly will look at the data and we have asked our research arm of the Department to actually work with us on the design of a study to actually, in fact, look at this particular issue as well as the broader one. Mr. Stupak. Can you assure the American people that based upon this faulty study on which you made your approval, you will suspend the use of carbon monoxide in modified packaging until you get the answers resolved here? This raises some serious issues, does it not? Mr. Engeljohn. I think we would still go back to the issue of the data that we were looking at were specific to the issue of whether or not spoilage would be an indicator here and whether or not we did not look at this from a safety perspective. Mr. Stupak. And you also look at deception, whether or not this packaging is deceptive to the American people? Mr. Engeljohn. Again, from our perspective, we did establish a use-by/freeze-by date as the mode in which a consumer would in fact be able to tell if this product were spoiled. Mr. Stupak. Let me ask Dr. Highbarger. I had asked you earlier. You've seen these studies. You saw these studies, right? Mr. Highbarger. I saw them, I don't recall them at all. I can't pull the numbers out of my head. That was 3 years ago. Mr. Stupak. All right. You're looking at the book there. Do you agree with me that when the microbial counts should have gone up, they were decreasing? When odor should have gone up, it decreased? That there are problems here as pointed out in those e-mails? Do you agree that there are problems in those studies based upon their own internal e-mails of Cargill and Hormel under Precept Foods? That we have some serious questions here now? I take it that is a ``yes.'' Let me ask Dr. Engeljohn. Dr. Engeljohn, you mentioned about the GRAS. Was there ever a GRAS study panel for this carbon monoxide use in the packaging? You usually get a panel together, don't you, to review it on the GRAS? Mr. Engeljohn. Not that I'm aware of, sir. Mr. Stupak. You usually do one, don't you? Dr. Post, you look like you want to answer. You usually do a GRAS review panel, you have a panel to review it before you-- -- Mr. Post. I'll answer ``no'' to that, but I'll also defer to my FDA colleagues to answer. Mr. Stupak. So there was no outside review, just your internal review of these studies submitted by Precept Foods, correct? Mr. Post. Yes. Mr. Stupak. My time is gone over. I know we talked about going 10 minutes. It looks like I went more than 10 minutes. Let's go for 10 minutes of questioning by Mr. Whitfield. Mr. Whitfield. Dr. Engeljohn and Dr. Post and Dr. Highbarger, I might say that our side of the aisle did not receive any of these documents that you were being questioned about until last night. And they're very technical documents. There is one aspect in here where it says that microbial growth was acceptable throughout the test for all treatments. We received them last night. Mr. Stupak. Excuse me. Mr. Whitfield, if I may. These documents were provided for some time. We found them over the weekend. Our staff worked yesterday. I worked yesterday, even though it was a holiday. We did find them last night. We presented them to your staff last night. Mr. Whitfield. We got them last night. Mr. Stupak. Right. They were attached, we believe, erroneous to a different document. And being good investigators that our staff is---- Mr. Whitfield. I'm not questioning how it happened. I'm just expressing the fact that we received it last night and these gentlemen were not aware of it until they were questioned about it just a few minutes ago. Mr. Stupak. Right. The question was not only on e-mail, but also studies that they've had since 2004. Mr. Whitfield. These were e-mails that Hormel had. These were internal documents, and I doubt that these gentlemen had access to it. But it certainly raises the question that you all can review this and come up with it. But to suggest that you would be able to give the explicit answers to these questions at this time, I think is unreasonable. Have you seen any of these documents before, any of the three of you? Mr. Post. No, we haven't. Mr. Whitfield. And so that is the point that I wanted to make on those. Mr. Stupak. If you may defer for a moment. Mr. Whitfield. Sure. Mr. Stupak. You never saw the e-mails until now. I never saw them until last night. But you've certainly seen the studies since 2004. You're the guys who reviewed it, right? Mr. Post. We have seen the studies that supported the decision in---- Mr. Stupak. So the issues I brought up about the converse order here where microbials were going up when they should have been going down, those are things you should have picked up in 2004, correct? Mr. Post. To my recollection, those were not the kind of results we saw. Mr. Whitfield. So those were not the results that you saw. But from the analysis that you did and from your decision, you made the decision that this using carbon monoxide and modified atmospheric packaging was safe from your standpoint; is that correct? Mr. Engeljohn. FSI has made the determination that the use of this technology and carbon monoxide was suitable for the use of meat and that a use-by/freeze-by date would be appropriate to identify the product would not be spoiled. Mr. Whitfield. And all packaging that uses it does have a date that it must be used by; is that correct? Mr. Engeljohn. We preapprove labels and all labels in carbon monoxide packaging on meat or poultry products must have a use-by or freeze-by date. Mr. Whitfield. Would it be accurate to say that the consensus of expert opinion and scientific opinion is that there is not a safety issue with using this packaging? Would that be accurate? Dr. Tarantino, would you agree with that statement? Ms. Tarantino. It certainly appears to. We haven't seen any real evidence of a public health issue or safety issue. Mr. Whitfield. Now, there has been some discussion about the European Union. Do you recall, Dr. Tarantino, receiving a letter from a Norwegian scientist at the Norwegian Food Research Institute? Ms. Tarantino. I do. Mr. Whitfield. And explaining that the use of CO in meat packing was banned by the EU for safety reasons? Ms. Tarantino. He expressed that and also expressed that it wasn't actually banned. It just was not approved in the EU, and it was not for safety reasons. Mr. Whitfield. So from your knowledge, it had nothing to do with safety issues? Ms. Tarantino. Not as far as I know. Mr. Whitfield. Dr. Acheson, in your testimony you noted that FDA had received a citizens petition challenging the FDA's acceptance of the GRAS status for carbon monoxide packaging in meat and tasteless smoke; is that correct? Dr. Acheson. That's right, yes. Mr. Whitfield. And what individuals or entities filed that petition? Dr. Acheson. I'd ask Dr. Tarantino specifically to give you the very specific answer to that, if I may. Mr. Whitfield. Dr. Tarantino? Ms. Tarantino. Calsak submitted the citizen petition for challenging our decision on carbon monoxide in meat and EnviroWatch, a group in Hawaii, filed a citizen petition about the decision on tasteless smoke. Mr. Whitfield. Do any of the followers, specifically Calsak have an economic interest in the FDA withdrawing GRAS acceptance for carbon monoxide? Ms. Tarantino. I'm aware they have a competing product. Mr. Whitfield. They have a competing product. So they do have an economic interest. Now, Dr. Acheson, let me ask you. What do you consider your responsibilities that you have at the FDA? What do you consider as the three most important food safety problems or the three biggest public health threats to the U.S. food supply? Dr. Acheson. Well, there are two ways that we could answer that. One is to look at the bigger picture of where do we need to go with food safety, which is essentially focused on building strong safety and upfront prevention, appropriate intervention, and rapid response. If you're going to address specifically what foods do we have the greatest concern about, then the way to approach that is what is causing illness, what is the public health risk? And what we're seeing is a variety of different types of fresh produce where we've seen repeated outbreaks. Issues with eggs is another high priority. So there are a number of them. And this particular issue is not a safety concern even remotely high on our radar screen. Mr. Whitfield. OK. So this carbon monoxide in packaging, as you said, is not remotely an issue? Dr. Acheson. From a safety perspective with limited resources, we have to look where the public health risks are. Mr. Whitfield. Now, Dr. Engeljohn, what about from your perspective, do you view this issue as one of your priorities for food safety? Mr. Engeljohn. This is not a priority for the Agency with regard to public health. We have other pathogens and other issues related to that. Labeling is an issue for which we do have statutory requirements to address, and we'd fit all of our labeling issues into a matter of prioritization that we have, with public health being the No. 1 focus. Mr. Whitfield. Now, I know that there are some consumer groups here in the second panel. But as a Member of Congress, I have not received any complaints that I'm aware of from any citizen about this packaging being a problem for consumers in my district. And you all, are you being besieged with letters from consumers expressing concern about packaging using carbon monoxide? Are you all receiving any information about that? Dr. Acheson. I'm not aware that we're being bombarded with those kinds of letters, but we recognize that this is clearly a concern for consumers and our committee to think further about it. Mr. Whitfield. Is the USDA at this time restricting competitors from advertising or marketing their products as carbon monoxide-free? Or USDA? Mr. Engeljohn. At USDA and the Food Safety Inspection Service, I'm not aware of any labeling. We would not consider such a label to be appropriate. All of the technologies that we approve labeling for are, in fact, safe; and the issue being whether or not it is suitable. Mr. Whitfield. Would there be any prohibition of a company putting on its label as carbon monoxide-free? Mr. Engeljohn. To my knowledge, we would not allow such a statement. Mr. Whitfield. You would not allow? Mr. Engeljohn. Would not. Mr. Whitfield. Dr. Post? Mr. Post. We'd allow statements about any technology that are truthful and not misleading, because we have a pre-approval requirement. The word ``free'' I think is a little problematic, I think, in this case. Mr. Whitfield. OK. All right. Now, have you all heard of Dr. Michael Osterhome at the University of Minnesota, or Mike Doyle of the University of Georgia? Any of you familiar with them? Dr. Acheson. Yes. Mr. Whitfield. And I think both of them and their institutions have conducted some studies on this issue; is that correct? Dr. Acheson. I believe so, yes. Mr. Whitfield. And from their studies, they have concluded that safety is not an issue with this packaging; is that correct? Dr. Acheson. I believe so, yes. Mr. Whitfield. OK. And both of them are leading experts in this field, with extensive scientific knowledge; is that correct? Dr. Acheson. Correct. Mr. Whitfield. OK. I have no further questions. Thank you. Mr. Stupak. I thank the gentleman. Ms. Schakowsky for questions, please. Ten minutes. Ms. Schakowsky. First, Mr. Chairman, let me congratulate you and our staff of researchers and investigators for providing us with information that makes it possible to really explore, apparently more fully even than the USDA on some of the information that we have. I've actually been pretty surprised that in preparation for this hearing, that the witnesses have not--for example, Dr. Acheson, you seemed unaware of the FDA's involvement with the issue of carbon monoxide. And I'm looking at your written testimony when it says GRAS, generally recognized as safe, notice for carbon monoxide right here; the notice to the FDA; the response dated February 21, 2002. I would have imagined that you would have been aware of your own testimony that referred to the involvement of the FDA in this issue. Let me put on my consumer hat; that is where I started in the grocery store, dealing with getting freshness dates on. Why do you think that this packaging is used? What is the intention of the packaging, Dr. Engeljohn? Mr. Engeljohn. The packaging, as with all packaging, would be in part to ensure that the product doesn't become recontaminated. That is the first issue. And it is the importance of packaging throughout the distribution chain. The use of the gas, in this case carbon monoxide, has a specific purpose which in this case is to remove oxygen and to---- Ms. Schakowsky. I guess I'm asking, again, from a consumer point of view. Is it not to make the product more acceptable to consumers by making it look fresher? Mr. Engeljohn. I think from the FSI's perspective, is that the use of the technology retains a color that is there in the product naturally within the shelf life that it normally would have for optimal use. Ms. Schakowsky. So you would not agree that the--that at least a partial intention of this technique is to make consumers believe--because we do look at color. Go into any meat department of any grocery store and watch people choose a product. And what they're looking for--because you can't put your face on the product and smell it--is looking for color. Is that not true? Mr. Engeljohn. Color is a very important indicator for the freshness of the product, yes. Ms. Schakowsky. OK. And so this technology takes away that signal from consumers. Is that not true? Mr. Engeljohn. This technology does not take away the signal entirely. It retains a color that would be there throughout the normal shelf life and optimal use of this product. And that's what we established the use-by date time. Ms. Schakowsky. One of the packages in front of you is 2 years old and it might look OK to consumers. Is that not a problem? Mr. Engeljohn. It is a problem from the perspective that it is critical that the use-by date be adhered to. And that is the reason why we approved the label with the purposeful intent of having a use-by date that is in fact based on the shelf life studies that we were represented. Ms. Schakowsky. Target has presented a letter--it is exhibit 76--asking the USDA to approve a label that Target would like to put on its meat packages that are packaged with carbon monoxide. They are seeking approval to affix a label containing the following information on those meat products. ``Consumer notice: Carbon monoxide has been used to preserve the color of this product. Do not rely on the color or the use or freeze-by date alone to judge the freshness of the product. For best results, please follow the safe handling instructions'', which I understand are on the product as well. Will you approve this label and allow Target to label its meat in this manner? Mr. Engeljohn. The Agency did receive that letter late Friday evening and it is under consideration. And our primary objective in evaluating that statement as one being submitted was to ensure it is truthful and not misleading. So we'd look at all aspects of what the statement would say. Ms. Schakowsky. And if you approve that language, will you direct that all meat packaged in an atmosphere containing carbon monoxide be labeled with the same language? Mr. Engeljohn. The issue would be making sure that the label is truthful and not misleading in those aspects, and then we'd make some consideration as to whether or not we need to reevaluate our original approval condition, which was solely the use of a use-by/freeze-by date. So it would be a part of the consideration that we would have. Ms. Schakowsky. Let me tell you that I think this discussion represents a kind of tone-deaf understanding of what consumers expect and want. Safety is certainly a major consideration, but we have technologies now that can take junk, really old food, and do all kinds of things to it so that if you consumed it, it would not hurt you, it would be OK. That is not the standard that American consumers want. They want to know that this product--that's why we look at color, so that we bring something home to our family that is fresh for them. Freshness is a concern for families regardless of whether or not it is going to make someone sick or, horribly, perhaps kill a child. So this is--I really would--if you want to be besieged by letters and phone calls and opposition, I assure you that that could happen if people feel that they are being deceived by a product, because it is not simply the notion of making someone sick. We have enough right now in the way of--I don't even know what you do when you put lights on things and all kinds--to get rid of the bacteria. It is not comforting to me to know that you can take fecal matter and make it not hurt me. I don't want it in my food. And the same issue, I want to be able to use my senses to decide what is for my family, and I feel that it is deceptive to allow a packaging that would take that away from me, especially since in the grocery store itself I can't literally smell the food, so I don't really have a lot of questions about it. But I think you ought to question the decision that you're making. I think that consumers do want, as consumers in Europe and other places--and you ought to look at the reasons for their--the decisions that they've made--want not to have something that discolors or artificially colors in some way their food products. I assure you that shoppers across the country will not be simply complacent about this. Thank you. I yield back. Mr. Stupak. Thank you. Mr. Burgess for questions, please. Mr. Burgess. Thank you, Mr. Chairman. Dr. Acheson, let me just ask you a question about the imports of fish and imported tuna that some of your testimony revealed elevated histamine levels, is that correct, in imported tuna? Dr. Acheson. [Non-verbal response.] Mr. Burgess. Is there any difference between carbon monoxide-treated tuna and noncarbon monoxide-treated tuna as far as the histamine levels are concerned? Dr. Acheson. Carbon monoxide really doesn't have anything to do with the formation of histamine. And this is actually a fairly complicated process in that there is a formation of histamine as a process that can occur in fish, and there is also the formation of odors that can form in fish which we'd normally call spoiled fish. These things happen generally in very different tracks. They are not the same thing causing one from the other. And so I think the complication here is that it would be nice if we could use the odor of fish to tell us whether there was histamine present. As a matter of fact, we can't. It doesn't work that way. And CO doesn't really have any impact on that ability. Mr. Burgess. So what is the purpose in using the carbon monoxide in the treatment of fish? Dr. Acheson. Either tasteless smoke or carbon monoxide is used principally in frozen fish because with the freezing and thawing, you get a change in color in that fish to something that is fairly unappetizing, you might say. There is nothing wrong with the fish. It is not spoiled, it is not decomposed, it is not dangerous, it is not lower in quality in any way. It has just changed color because of the freezing and thawing process. And as a result, there is difficulty in marketing that kind of product, and the industry has found by treating the fish with either CO or tasteless smoke, they are able to retain that color that it had immediately before freezing, which actually serves some benefit because marketing of frozen fish that can produce histamine is a safer way to market the fish, because it very much reduces the ability of the fish to produce histamine when it is frozen as compared to when it is marketed as refrigerated. So there is actually some health benefit there. Mr. Burgess. So the freezing then, the physical activity of freezing the fish, delays the production of histamine in the fish, and the carbon monoxide treatment allows you to market the fish that has been frozen. So indirectly, then, there may well be a benefit to the consumer of lower levels of histamine in fish that still looks palatable when it is thawed. Dr. Acheson. That is fairly possible, yes. Mr. Burgess. Have you ever done a study that compares high histamine levels and decomposition in carbon monoxide-treated foods versus those present in noncarbon monoxide-treated seafood and concluded that a higher percentage of decomposition histamine levels are found in seafood treated with carbon monoxide? Dr. Acheson. I'm not aware of any study that has done that. We're certainly aware that carbon monoxide-treated fish do sometimes have histamine present. We're also aware that fish that are not carbon monoxide-treated also have some occasions where histamine is present. And, of course, this is something that FDA tries to regulate at the border through testing. Mr. Burgess. So are there other products besides tuna that are treated with carbon monoxide, other seafood products? Dr. Acheson. We are aware that tilapia might also be treated, and probably is with some regularity. Mr. Burgess. Is that OK? Is that within the scope of the regulations? Or is that an adulteration of the product? Dr. Acheson. There has been no GRAS notification for the use of CO or tasteless smoke in tilapia. But by the same token, the statute does not require someone using CO or carbon monoxide--a GRAS substance, let me put it that way--does not require someone to notify FDA if they are using a substance they believe to be GRAS. That is just the way the statute is written. Mr. Burgess. And it makes no difference whether that tilapia--is any tilapia produced domestically, or does it all come from foreign sources? Dr. Acheson. I believe there is some produced domestically, but it is mostly a foreign product. Mr. Burgess. And there would be equal treatment of that product with carbon monoxide whether it is produced domestically or imported? Dr. Acheson. Yes. Mr. Burgess. OK. If FDA did make a determination that the use of carbon monoxide was resulting in an adulterated product, you would stop that at the border; is that correct? Dr. Acheson. The difficulty here is that, as you have heard the discussion before, is that with limited resources we try to focus our resources on food safety issues. Mr. Burgess. But if you thought it was dangerous---- Dr. Acheson. If we thought it was dangerous, we'd certainly stop it at the border. That's absolutely correct. Mr. Burgess. Is this just enforcement discretion or does this speak to the benign nature of carbon monoxide treatment of seafood products? Dr. Acheson. I think it is enforcement discretion. The issue of--first of all, tilapia doesn't produce histamines. So that issue isn't even an issue for tilapia. So that takes out even the discussion of that issue associated with tilapia. But the fact that it may in fact constitute an economic adulteration, arguably that could be the case. But FDA does need to decide where we need to put our resources. So I think this is, in fact, enforcement discretion and putting our recourses on the food safety issues that Dr. Acheson mentioned a few minutes ago. Mr. Burgess. Would you restrict competitors who were selling this competing seafood product that didn't use carbon monoxide, would you restrict them from mentioning in advertising or marketing that competing imports are using carbon monoxide without FDA notification or acceptance? Dr. Acheson. In their advertising? Mr. Burgess. Yes. Dr. Acheson. I'm not aware that that is a prohibition. Mr. Burgess. Again, does that speak to a problem with the laws in that arena, or does it speak to the fact that carbon monoxide treatment is again a real--regarded as a relatively benign process? Dr. Acheson. Because if competitors felt it was an advantage, they'd be--they'd be advertising in that way? Mr. Burgess. Yes. Dr. Acheson. I'm assuming that they made the decision that it is not worth their while to market in that way. Mr. Burgess. We all recall the tuna advertising plans that dealt with the--I forget whether it was the capture of tuna or sea turtles in the nets that captured the tuna. Was it walruses? It was dolphins. Obviously there was a competitive advantage to advertising dolphin-friendly tuna. I know that's what I always look for. I would never buy dolphin-unfriendly tuna knowingly. What does the--in your opinion, what does the FDA believe would be the public health impact from requiring notice and comment for all of the generally regarded-as-safe petitions? Is there any concern that this would stifle advances in innovation that might in fact, if not stifled, improve food safety? Dr. Acheson. I think Dr. Tarantino is probably better able to answer that question. Ms. Tarantino. Sure. First of all, I think as Don mentioned as well, if something is GRAS, you don't have to notify us or come to us at all. Notice and comment rulemaking certainly takes a very long time and there are situations when you have to do it. Mr. Burgess. How long a period of time? Dr. Acheson. It depends on what the issues are. It does require a publishing proposal, taking comments and then doing rulemaking. Mr. Burgess. Days, weeks, months or years? Ms. Tarantino. Years. And I think what is also true is the process. The GRAS notification process is about as transparent as the food additive petition process. In both cases--in one case we put the notice on the Web, and in the other case we put a notice in the Federal Register. And in neither case do we go out and actively solicit comments, but people have an opportunity to comment and give information as much as possible. So we try to make the GRAS notice process as transparent as is possible, while keeping it a fairly efficient process, because we want to encourage people to come to us, because we get much more information about what is in the food supply and can stop it if we know about it. Mr. Burgess. I see. Let me just ask anyone on the panel who can answer the question. I've been primarily talking about seafood products, but this would apply to beef products as well that are treated with carbon monoxide. What happens to the carbon monoxide when the food is cooked? Does the hemoglobin molecule denature and break apart and the carbon monoxide is then released? And since we're talking about concentrations of four-tenths of 1 percent, that obviously would not pose a hazard to someone inhaling carbon monoxide, would it? Mr. Highbarger. I can't give you any numbers, but the majority of the carbon monoxide would be just blown off from cooking. So you'd be eating almost nothing. I can't give you numbers. Mr. Burgess. The exposure to carbon monoxide to temperatures normally involved in cooking would not create any new compound or substance which might in turn be harmful to the consumer? Mr. Highbarger. There is no chemistry there that could happen, no. Mr. Burgess. Thank you, Mr. Chairman. I will yield back. Mr. Stupak. Thank you. We will go for another round of questions. Mr. Kraemer, Mr. Burgess had asked you about the treatment of fish with either tasteless smoke or carbon monoxide, correct? Dr. Acheson. Yes. Mr. Stupak. And you said they treated it with using either one, tasteless smoke or carbon monoxide, correct? Dr. Acheson. Yes. I referred to--I responded to both, yes. Mr. Stupak. Does the FDA decipher between the two for labeling purposes? Dr. Acheson. Yes. The labeling would be different depending upon what was being used. Mr. Stupak. What is the label for tasteless smoke? Dr. Acheson. Tasteless smoke would need to say ``preserved with tasteless smoke,'' I think is the correct terminology. Mr. Stupak. Tasteless smoke is really carbon monoxide, is it not? Dr. Acheson. One of the components of tasteless smoke is carbon monoxide. Mr. Stupak. OK. What is the label for carbon monoxide, then? Dr. Acheson. Presumably, it would need to say ``preserved with carbon monoxide.'' Mr. Stupak. OK. Let me show this picture up there. The person is wearing a respirator, spraying seafood. Would that be tasteless smoke or carbon monoxide? Dr. Acheson. I can't tell from the photograph. I don't know. I've not seen the operation of either process. Mr. Stupak. All right. If tasteless smoke is the same as carbon monoxide, then why not just label truthfully as carbon monoxide and not tasteless smoke? Mr. Burgess. Mr. Chairman, I'm going to object. How can he possibly know what that individual would be spraying? No one can tell just from a picture like that. We don't see a canister, we don't see a label, we don't see a skull and crossbones, a biohazard label. It is illustrative only for the purposes of inflaming the rhetoric. I see nothing to be gained by showing us that picture. I yield back. Mr. Stupak. We'll get to the picture with the second panel. We'll lay the proper foundation, OK? So if tasteless smoke is the same as carbon monoxide, then why not just label it truthfully as carbon monoxide and not tasteless smoke? Dr. Acheson. They are not the same. One of the components of tasteless smoke is carbon monoxide, but there are other components as well. Mr. Stupak. What else do you get with tasteless smoke other than carbon monoxide on your seafood? Dr. Acheson. What else is in tasteless smoke? I believe nitrogen is one of the components. Mr. Stupak. Does that adhere to the fish, then, when you're using tasteless smoke? Dr. Acheson. No. I don't think it has any effect on the fish. It is essentially inert. Mr. Stupak. So the only thing that reapplies into the fish when using tasteless smoke is carbon monoxide, right? Dr. Acheson. The component that causes the effect of color- fixing is carbon monoxide. Mr. Stupak. So why don't you just call it carbon monoxide and not tasteless smoke? Dr. Acheson. I think it is a truthful statement to call it tasteless smoke, because in fact that is what it is. Mr. Stupak. But there is no smoke, there is no taste because it is tasteless. It is carbon monoxide. Dr. Acheson. It is tasteless. Mr. Stupak. You take tasteless smoke and put all the impurities, what do you have left, carbon monoxide, correct? And a little nitrogen? Same as CO carbon monoxide, right? When you use carbon monoxide, you have a little nitrogen left over too? Mr. Kraemer. The active ingredient, if you will, is carbon monoxide. Mr. Stupak. OK. Let's go back to Dr. Post. Mr. Whitfield sort of indicated like we sort of sprung a surprise on you, even though you're the guy that did the study 3 or 4 years ago. Let's go back to your document binder, 71(d) and 71(e); 71(d), I'll grant you, is the document we found in our files that we received from Hormel with the e-mail. And in 71(d), pages 3, 4 and 5, are the data that I referred to when I said that the microbial levels start out high and ended low, and where the microbial counts correlated inversely to gas formation and odor scores. So those are the three labels. If you go to 71(e), exhibit 71(e), which is--starts off, first two pages, from the law firm of Hogan & Hartson. Then inside, page 3 is Excel, the use of carbon monoxide in lid stock on ground beef. And that is the study they submitted in which you based your approval and--am I correct? Mr. Post. I would need more time to look at this and the original submission. I can't tell from the complexity of the data. Mr. Stupak. That is a copy we got from you, from FDA and from the Department of Agriculture. Well, let's go to the last three pages of exhibit E and exhibit D, they are the same. The data is the same, is it not? It shouldn't take a lot of time to figure that one out. It is pretty clear that the last three pages in E, the data submitted to you, the last three pages in exhibit D, the internal memo with the e-mail that questions the validity of the study, those are the same three pages, the data, whether it is the e-mail or your study was based on those three pages of data--is that correct--where the microbial levels started off high and ended up low and where microbial levels correlated inversely to gas formation in the overall score; is that correct? Mr. Post. They appear to be the same, yes. Mr. Stupak. OK. Thank you. Let me ask this question. Dr. Acheson, you said there has been no complaints at the FDA about carbon monoxide. Has the FDA done any studies to determine if consumers are aware, in fact, that carbon monoxide is being used to treat their meat? Dr. Acheson. No, the FDA hasn't. But we're considering undertaking some. Mr. Stupak. So if no one knows about it, they can't really complain, can they? Dr. Acheson. I think people know about it. Mr. Stupak. No. Dr. Tarantino, let me ask you this. You mentioned the Norway study in questions, I believe, with Mr. Whitfield. And you said Norway--in fact, it is exhibit No--if you want to look in the exhibit book, I believe it is exhibit No. 30. That is the Norway study I believe you were referring to, correct? Ms. Tarantino. My No. 30 is a publication from the University of---- Mr. Stupak. Go to the next one, 31. Mr. Whitfield asked you about Minnesota, too. So I'll ask about that later. Ms. Tarantino. That is one publication from their data. Mr. Stupak. Right. Is that the Norway study you're talking about, where you thought they had no concerns about carbon monoxide? Ms. Tarantino. It is not the only one, but we have the raw data from their studies. But this is one publication. Mr. Stupak. Sure. That starts with page 201. Go to page 218 of that study. Page 18 right in there. Lower right-hand corner, last sentence says ``and the safety of MAP,'' or modified packaging, ``products are mostly threatened by temperature abuse.'' Would you agree with that statement? Ms. Tarantino. The author of this study I think has written to say his words have been misinterpreted. What he was saying was that safety of meat is threatened by temperature abuse of any kind, including this modified atmosphere packaging and any other packaging. Mr. Stupak. Sure. So let's go to exhibit 30, then, the first one I asked you to refer to. And this is our University of Minnesota, Department of Food Science and Nutrition, where both Cargill and Hormel are located in Minnesota. And it starts off that the abstract basically says that the temperature abuse's main concern is for chilled and/or MAP meat and poultry products, since it is not the only cause of economic loss, but also made to food-borne illness hazardous, correct? Ms. Tarantino. I don't see the terms, but OK. Mr. Stupak. OK. Let's go to page 218 of that study. It starts on page 201 and goes to page 218. And let me just ask you this based upon your knowledge--or maybe Dr. Post or one of the others would like to comment on it. It says in the middle of the page that the microbial population of fresh meat is affected by many factors such as the number and distribution of microbial species present at the start; health and handling of the live animal; slaughtering practice; chilling of the carcass; sanitation; type of packaging and handling throughout distribution and storage; is that correct? Ms. Tarantino. I see the line, yes. Mr. Stupak. Would you agree with that, all of those factors go to microbial? Ms. Tarantino. It certainly sounds like it, yes. But I would defer to the USDA, too. Mr. Stupak. OK, thanks. Mr. Highbarger, in the letters from Dr. Post or to you to Dr. Post, back and forth, on approving this process here, did you look at the data that was submitted by Precept Foods in response to the April 28 letter? Did you look at that data? Mr. Highbarger. I don't believe so on that one. Mr. Stupak. OK. Mr. Highbarger. That was not submitted to us. Mr. Stupak. The letters going back and forth were to you, correct? Mr. Highbarger. That's correct. Mr. Stupak. From ``Mr. Post developed this,'' and on the April 28, 2004 letter he brought up again three times, on top of page 2, bottom of page 2, about the deception that may cause or mislead consumers into believing the product they are purchasing is fresher than it actually is, correct? Mr. Highbarger. Yes. Mr. Stupak. It is exhibit No. 18 if you want to look at it. Then on exhibit 19, when he apparently goes through the study and comes up with the wrong conclusions of the study based on the data, he never mentions the deception to the consumer. Did you ever ask him why--if that was--you raised it three times in your initial letter, the deception to the consumer. How come before you gave final approval you never discussed the deception to the consumer? What happened in the next 6 weeks or so? No one cared about the deception to the consumer, or you didn't have any concerns about it? Because he was addressing the letter to you. You see, he never mentions deception. The first letter, he mentioned it three times. The second letter to get the approval from you, he never mentioned deception. What happened? Mr. Highbarger. Well, I would interpret to say--because I haven't seen this letter for 3 years, obviously. Under the proposed conditions of use, the scores and subjective evaluations were shown to be acceptable during a shelf life of 20 save days under the proposed conditions---- Mr. Stupak. Correct. But you never mentioned deception to the consumer. I guess that is the part that bothered me. Mr. Highbarger. That is inherent in it. Mr. Stupak. That is inherent in it. OK. Dr. Post wrote to you. So you're the person who then finally approved the carbon monoxide in the packaging to be used? Mr. Highbarger. I'm a member of the team who evaluates all the information, yes. I'm the point of contact. All the communication comes through me. Mr. Stupak. You said you didn't see the studies then. How did you evaluate to reach your conclusion it was OK to do this, to put carbon monoxide in packaging, if you never reviewed the studies, those three pages I talked about in exhibit 71(d) and 71(e)? Mr. Highbarger. I obviously deferred to the USDA. Mr. Stupak. To whom at the USDA would you have deferred to; to Mr. Engeljohn? Mr. Highbarger. Through the memos that they sent us saying that it was acceptable under the proposed conditions of use. Mr. Stupak. OK. You're a scientist, right? Mr. Highbarger. Yes, I am. Mr. Stupak. So if you had seen where the microbial levels started high and ended low and where microbial counts correlated inversely with gas formations and odor scores, you would have caught that and you would have rejected that study? Mr. Highbarger. I would have to look at it before I could say anything. Mr. Stupak. OK. So will you look at it now? Because if my statement is correct, then in the study you based your decision upon, the microbial levels started high and ended low and where microbial levels correlated inversely with gas formation odors. If that is true, as in exhibit 71(d) and 71(e), you've got to reverse your decision then, right? Mr. Highbarger. I'll certainly look at it. Mr. Stupak. When can you do that? This is a matter of importance to this committee. That's why we're having this hearing. When can you convene your GRAS panel and review this data? Dr. Tarantino? Ms. Tarantino. We'll talk to FSIS and look at the data and look at the study. But remember, our decision on whether we do something on the pending matter of the citizen petition or overturn the GRAS will depend on everything we see, including this study and including looking at what these numbers say. Mr. Stupak. But if your initial decision was wrong based on this study, shouldn't you suspend the GRAS then until--is there a procedure to suspend the GRAS while you study this further? Is there a procedure? Can you do that? Ms. Tarantino. The procedure would be that we'd have to say that we no longer agree that it is GRAS, that it is an unapproved food additive, and build a record and a case that supports that. Mr. Stupak. An unapproved food additive. Why wasn't it considered a food additive when it was first considered? Ms. Tarantino. Because, as was said earlier in the testimony, that GRAS substances are exempt from the definition of a food additive. They do not require premarket approval. Mr. Stupak. Well, we look forward to you convening your GRAS review panel and review this study in depth, and I hope you have all the raw material, not just the flow charts given to us. Mr. Whitfield with questions. Mr. Whitfield. Thank you, Chairman Stupak. We focused a lot with this panel on safety issues of which the general consensus seems to be there are no safety issues. And then we also focused on deception. And there has been a lot of discussion about deceiving the consumer to believe that meat is more fresh than it really is because of the use of carbon monoxide. From a legal standpoint, what legal responsibility does FSIS at USDA have about food deception, of policing food deception? Mr. Engeljohn. Our statutory authority requires us to ensure that product is not misbranded, mislabeled, and so it is an issue which we'd take into consideration in our determination of whether it is---- Mr. Whitfield. Could you give us an example of something that has been referred to as deception from your jurisdiction in the last couple of years? Mr. Engeljohn. Well, one issue that is probably easier to understand in terms of a deception and why we don't allow it in meat products to begin with would be paprika. It is a compound that--or spice--when used has a red color. And although it does cause the lean tissue to turn red or stay red, it also causes the fat to turn red and stay red. So the product appears to be more lean than it is. So that is a determination of perhaps an economic adulteration situation. So we do not allow it for that reason. Mr. Whitfield. But on this particular issue from the perspective, the official position of USDA, is that you do not view this as deception by the use of carbon monoxide; you do not view that as a deception, do you? Mr. Engeljohn. We do not view the use of carbon monoxide as a deception when there is a use-by/freeze-by date on the package which is, in fact, the determinant for whether the product is optimal. Mr. Whitfield. And I don't know if you've seen all these samples that are out there, but I'm assuming that all these sample packages have use-by dates on them; is that correct? Mr. Engeljohn. If they are treated with carbon monoxide, they must have it on there, or they are improperly labeled, and that would be a violation of our requirements. Mr. Whitfield. But if they do not use carbon monoxide, they do not have to have a use-by date on there? Mr. Engeljohn. That is true. If they do not use carbon monoxide in the packaging, and use other gases including oxygen or any series of other combinations of gases, there is no use- by or freeze-by date, and they do in fact have a tendency to cause the color to be retained as long as the product is in the package. So virtually any product in a package is going to have delayed spoilage in terms of changes with microbiological content as well as color and other indicators. Mr. Whitfield. Were you going to say something, Dr. Post? Mr. Post. I'm just agreeing with him. Mr. Whitfield. OK. I yield back. Mr. Stupak. Ms. Schakowsky, questions? Ms. Schakowsky. I do. Let me see if I understand about the imported fish that we have. About 80 percent of the fish that we have is imported; is that correct? Dr. Acheson. That is correct. Ms. Schakowsky. Would you say that almost all of it is packaged with CO? Dr. Acheson. I'll ask Mr. Kraemer to try to give you an estimate as to what percentage of that is packaged with CO. Mr. Kraemer. I would say for all fish, it is a very small percentage. But for tuna, we don't know what the exact percentage is. But I would say it is a significant percentage. Ms. Schakowsky. And what percent of FDA tests show that the fish is actually decomposed or may have histamines--or do we know--of the inspected fish? Dr. Acheson. What I do know is that between 2001 and 2005 we had about 4,800 samples of decomposed fish. But what I don't know--if we can find for the record--is what the denominator is for that. Ms. Schakowsky. Apparently we've been asking this question on this committee since May, and we really would like to get that information from you. Dr. Acheson. OK. Sure. Ms. Schakowsky. Dr. Tarantino, isn't it true that under FDA, that any substance that is a component or otherwise affects the characteristics of any food is considered a food additive? Ms. Tarantino. Yes, unless it is subject to one of the exemptions in that definition. Ms. Schakowsky. Isn't it also true that as a food additive the substance is then subject to premarket review and approved by FDA unless it falls within one of those definitions? Ms. Tarantino. That's right. Ms. Schakowsky. One of the major exclusions is GRAS are generally recognized as safe under the conditions of its intended use, correct? Ms. Tarantino. Correct. Ms. Schakowsky. So today we're discussing meat packaged in an atmosphere containing carbon monoxide and the exposure of seafood to carbon monoxide before freezing. And these processes were determined to be GRAS. That's correct, right? Ms. Tarantino. Yes. Ms. Schakowsky. Under 21 CFR, paragraph 170.35, the affirmation of GRAS status must occur through the notice and comment rulemaking process in which FDA publishes a notice in the Federal Register, allows 60 days for comments, evaluates the comments and then determines whether the substance is GRAS--Generally Recognized As Safe--is that correct? Ms. Tarantino. Or FDA to affirm that something is GRAS, that's correct. We did not do that in this case. Ms. Schakowsky. Well, that's really where I'm going. It says, however, GRAS notice 015, which allows tuna to be exposed to tasteless smoke, and GRAS notice No. 143, which allows meat to be packaged in an atmosphere containing carbon monoxide were both determined to be GRAS without following the notice and comment rulemaking process; isn't that true? Ms. Tarantino. The GRAS exemption does not require FDA to participate in the GRAS determination at all. So in those cases, it was the party, the manufacturer, who made the determination that it was GRAS, and then voluntarily notified us of both its determination and all of the information and studies on which it based that determination, and gave us an opportunity to react to that and to see whether we had any questions or not. Ms. Schakowsky. So in other words, you're saying that it is on the say-so--I'm trying to understand this process and how it differs from 21 CFR that the GRAS status must occur through the notice and comment rulemaking process which FDA publishes in the Federal Register, comment period, et cetera. Ms. Tarantino. The regulation that you're referring to is that if--how we do it if the FDA decides to make a statement that something is GRAS and to affirm the GRAS status. That is the current regulation for how to do that. As I say, people can determine GRAS status without coming to us, without notifying us, without coming to us at all. The GRAS notification procedure gives them an opportunity to voluntarily come to us and gives us an opportunity to know better about what is in the food supply so that if there are safety issues or are issues about the GRAS status, we can raise questions about it. Ms. Schakowsky. OK. Well, forgive me, then. Are you saying that for something to be determined generally recognized as safe, who is the arbiter, then, of that? Ms. Tarantino. Experts, experts. The definition says generally recognized to be safe by experts who are qualified by training and experience to judge the safety of food. Ms. Schakowsky. And who can be those experts? Can these be experts that work for or are hired by the company seeking this GRAS---- Ms. Tarantino. They can be. But the information on which a GRAS determination is based is not just a company doing its own studies in its own laboratory and then submitting it to the Agency. That information needs to be generally known. So, often that is through publications in the peer-reviewed literature. It can be in many different ways. It can be through principles in chemistry as part of the reason for carbon monoxide. It can be a lot of different ways that the information is publicly known so those experts, wherever they are in the world, can see whether the information does support the safety or does not. Ms. Schakowsky. We are hearing today that there is some difference among experts. And the GRAS notices that we're talking about today were determined under a proposed rule dating back to 1997. The proposed rule would replace the GRAS petition process, create a new GRAS notification procedure under the proposed rule, no notice, no comment process. And as you said, the FDA doesn't perform its own research, but instead only looks at what the notifier has supplied in support of its GRAS determination. So essentially this is an ex parte process where FDA only considers the information that the notifier wants it to. Ms. Tarantino. We also look at other data that is out in the public arena. We look at any information available to us in our files or available to us through the literature and the scientific basis. Ms. Schakowsky. It looks to me like this is just another example where the FDA has filed proposed rules instead of its own regulations. Under Federal law it is a well-settled rule that an agency has to file its own regulations. So it looks to me like the FDA violates the law by not doing this. Ms. Tarantino. If we were to affirm the GRAS status of a compound on our own, we would use notice and comment rulemaking. The regulation you are reading was a regulation we proposed to give a mechanism for those who wanted to get an opinion from us as to whether their GRAS determination was correct. That was one mechanism that we put in the regulations. The GRAS notification is a mechanism that we have also proposed and are using, which does the same thing. It allows people who have made a GRAS determination to come to us, to let us know what they are doing, what they're selling, what they're marketing, and gives us the opportunity to object if we see a problem with it. In many cases, when the process was very burdensome, people just didn't come to us at all. So one of the big advantages of the notification process is it encourages people to come in with some regularity, we do object to their GRAS determination. Ms. Schakowsky. When something is determined to be generally recognized as safe, it is pretty hands-off then. Ms. Tarantino. No. There are processes by which we can go back and revisit those decisions and we---- Ms. Schakowsky. Like we think maybe today's hearing might prompt---- Ms. Tarantino. No. The citizen petitions that have been filed are processes that have been developed specifically for that purpose. Ms. Schakowsky. Did you say some petitions? Oh, yes. The petition on this, I was just told, is 2 years old. So how promptly is---- Ms. Tarantino. Well, I think everyone here has said we're interested in new information, and there has been a lot of information submitted to that docket on that petition up until quite recently that we are very interested in looking at. Ms. Schakowsky. And wouldn't a notification and comment period make it easier to solicit other expert testimony as well as consumer input? Whether or not the FDA actually does its own testing? Ms. Tarantino. It would be one way, I suppose. But I think we've tried to accommodate that by making sure the people have notice that the notification is in and with the agency who submitted it, what it is for, as promptly as is feasible. Ms. Schakowsky. Dr. Acheson, I think, said that people know that meat is treated with CO. Wrong. I think that's absolutely not true that most people think when they're at the grocery store that the reason for that bright red color is because it has been treated. Hopefully, that word will get out more and will help people in their decision-making, but I don't think at this point that is true. Thank you. Mr. Stupak. Thank you. Mr. Burgess, questions? Mr. Burgess. Thank you, Mr. Chairman. Dr. Tarantino, maybe you could expand or provide a little context for the answers to the questions you just gave Ms. Schakowsky. What would be the effect of expanding the comment process for determining whether a process was generally regarded as safe? Ms. Tarantino. I'm not entirely clear how one would do that, but I suppose you could say that we could, in a final rule, for the GRAS notice process or in some part of the process, go out and explicitly seek comments. We do get comments on GRAS notices pretty regularly. Mr. Burgess. But expanding the notice and comment process, would that have the net effect of slowing things down? Ms. Tarantino. Oh, sure. Mr. Burgess. Well, we keep talking about 1997. I referenced it in my opening statement, and we heard it mentioned here again just a minute ago. What happened in 1997? Ms. Tarantino. In 1997, I think there was a general recognition--no pun intended--that the process that we were using for doing petitions to look at whether something is GRAS was kind of an unusual situation. We had set up a petition process for people to ask us whether they need to petition us as a food additive, and we would say no, but it would take a long time because it was a very cumbersome rulemaking process. And the end result of that is that most people made their own GRAS determinations, went to market, and then depended on us to make a postmarket finding. If we disagreed with them, we'd have to take an enforcement action. Mr. Burgess. We already talked about the timelines to some degree. Again, are we talking about days, weeks, months, years or decades? Ms. Tarantino. Years. It was years. So it was a big disincentive for people to come to us and tell us about what they were planning to market. As to the process we did, one of the main reasons was to make it a more efficient process while encouraging people to come to us so we would have a much better view of what was in the marketplace, what was being developed, what the new technologies were, and that if we did have an issue, we could review what was sent. We could review the information that was out there publicly, and if we had an issue or a concern, we could express that concern right away. Mr. Burgess. So, in other words, the agency made the decision, rather than to be punitive, they'd try to be helpful? Ms. Tarantino. That certainly was a better way of going about it to do it ahead of time so that we wouldn't need to use enforcement resources, but have the review done before it went to market. Mr. Burgess. Well, since it seems to be the object of a lot of discussion--I've got to tell you, I'm kind of mystified as to why we're having this hearing. There are a lot of other things we could be talking about--salmonella, E. coli, you name it--but we're talking about bugs that I can hardly pronounce. What would be required just to simply close up this process--close up the rulemaking process and get a determination on the rulemaking process? From 1997 to 2007, that's a decade. Even for a slow-moving Federal agency, that seems like a reasonable amount of time. Ms. Tarantino. We are all very interested in closing that out and in writing a final rule to put this process in the regulations. Mr. Burgess. So, as a practical matter, what is left to do? Ms. Tarantino. To make sure that, in the intervening years, nothing has changed. And we may look for additional comments to see if anything has changed, but we want to get that final rule out as much as anyone does. Mr. Burgess. Well, in the intervening decade a lot has changed. We're getting much more of our foods from--we've already heard in other panels before this committee that we're getting an enormous number of our foodstocks imported from overseas. It seems to me that the American public would be better served if we were to allow the agency to be a little bit more flexible, a little bit more agile about responding to these new threats that are coming in, and we, yet, seem to be mired in the 1997s and not able to move forward. Ms. Tarantino. The process we are operating under now is operating under that proposal because it was a voluntary process. Mr. Burgess. Do you feel like it's working? Ms. Tarantino. I do very much. I think it works quite well. Mr. Burgess. Would you be in favor of our turning the clock back and going back to 1997 or prior to 1997? Ms. Tarantino. Before? Personally, no. Mr. Burgess. You don't think that American public safety would be greatly enhanced by doing that? Ms. Tarantino. No. I believe the current processes are very protective of public health. Mr. Burgess. Would it be detrimental to go back to the type of processes that we had prior to 1997? Ms. Tarantino. I think it would be much more resource- intensive, and it would be hard to know whether you would get very much benefit from it. Mr. Burgess. OK. Thank you. You've been very candid with your answers, and I appreciate that. We've got a lot of doctors on the panel. Do we have a lawyer? Someone needs to help me with this term ``ex parte'' because it keeps coming up. Being a simple country doctor, is that like a unilateral comment that's made? Let me just ask anyone on the panel, either the FDA or the USDA. Does it violate some process, or is it in any way illegal to have these ex parte comments on regulation or guidance? Dr. Acheson. I personally cannot answer your question. I don't know. Maybe one of my FDA colleagues can. I would have to get back to you with an answer for that. Mr. Burgess. OK. It keeps coming up. We saw it in the majority's report to the committee. Mr. Burgess. Kind of going back to carbon monoxide for just a moment, either Dr. Acheson or Mr. Kraemer, does the FDA have any concerns about the safety and the use of the 0.4 percent atmospheric carbon monoxide in packaging? Dr. Acheson. From a safety perspective, we do not. Mr. Burgess. Can we regard it as simply a packaging material? We've already heard in the last round of questioning I had that it's volatile; it goes away when the food is cooked. So, from the consumer's perspective, is it any different from the cellophane that helps to keep the food fresh? Dr. Acheson. It's considered by us to be a fixative, a preservative of color. It has got nothing to do with freshness per se. It's color. Mr. Burgess. It's coloration. So is it bound by the same rules that other coloration agents are held to? Dr. Acheson. Well, my understanding--and I'll ask Dr. Tarantino to clarify--is that it's bound by preservative approaches as opposed to that it's not considered to be a color additive. Mr. Burgess. Oh, it's not a color additive. Ms. Tarantino. Right. It is a color fixative, which is different from a color additive. A color additive imparts new color. Mr. Burgess. So, as a scientific matter, there is a difference between a fixative and an additive? Dr. Acheson. Yes. A fixative maintains color as is. An additive is, by definition, an addition. Mr. Burgess. Is there any difference in the use of carbon monoxide in seafood products as opposed to meat products? Dr. Acheson. Well, what do you mean? Mr. Burgess. Does the FDA have a view as to the carbon monoxide used in seafood, in fish products? Is it identical in all respects as a fixative in fish products as it is in meat products? Dr. Acheson. Yes. Mr. Burgess. OK. Thank you, Mr. Chairman. I yield back a minute and a half. Mr. Stupak. Thank you, Mr. Burgess. Mr. Dingell for questions, please. Mr. Dingell. Mr. Chairman, thank you. This question is to Dr. Tarantino. Doctor, what record was completed by the FDA in connection with the issuance of whatever rule was issued by Food and Drug with regard to the CO insertion into the packaging? Was there any record established at all by Food and Drug on this matter? Ms. Tarantino. There is an administrative file for each of the GRAS notices. Mr. Dingell. Was there any action taken by Food and Drug which would comply with the requirements of the Administrative Procedures Act? If so, what? Was there a finding made that the actions of Food and Drug were in compliance with the Administrative Procedures Act? Ms. Tarantino. The notification to the agency was made voluntarily by companies who chose to notify us---- Mr. Dingell. What about consumer groups? Was there ever notice given to the public? Ms. Tarantino. The---- Mr. Dingell. Yes or no? Was there notice given to the public? Was notice filed in the Federal Register? Ms. Tarantino. The notices were put on the Web. Mr. Dingell. On the Web. They were not printed in the Federal Register? Ms. Tarantino. No. We were using the Web. Mr. Dingell. What responses were received? How many? Ms. Tarantino. On the notices for the meat, I do not believe we got any comments between the time that we put the notice on the Web and when we made the final decision. On tuna, we may have. I think we did, but I'd have to check. Mr. Dingell. So the answer is you don't know? Ms. Tarantino. As I said, I think we did for tuna. Mr. Dingell. Does anybody at Food and Drug know? Ms. Tarantino. We can find out and get back to you. Mr. Dingell. Don't you think you ought to be able to answer that question when you're appearing here to discuss these matters? It would seem so to me. Dr. Acheson. Sir, we try to be as prepared as we can, but certainly there are times when we just don't have all the information. We'd be happy to get back to you for the record on that. Mr. Dingell. I find myself surprised. Now, Dr. Tarantino, why are there no e-mails, drafts or like documents that would indicate your thinking as the carbon monoxide questions were under consideration that have been produced to this committee? Are there such documents? Are there such e-mails? Are there such drafts in the records of Food and Drug? Ms. Tarantino. We have made an attempt to be responsive to your---- Mr. Dingell. All right. I'm going to ask you to submit them to the committee, all of them. I'm going to ask unanimous consent, Mr. Chairman, that the record remain open so that they may be submitted and may be included. Now, why have several documents regarding communications with the Office of Chief Counsel regarding seafood been produced from the Office of Seafood files, but there's nothing regarding the meat decisions? Can you answer that question? Ms. Tarantino. We have produced everything we have found thus far, and we are continuing to look. Mr. Dingell. So you don't have anything with regard to the meat decisions? Ms. Tarantino. Only the things that have been produced thus far are what we've found so far. Mr. Dingell. Now, were the lawyers consulted on this matter? Ms. Tarantino. No, not that I recall. Mr. Dingell. So they were not consulted. Mr. Highbarger, why were no e-mails or other documents from your office produced until last week when the Office of Legislation was attempting to have you removed from the witness list? Mr. Highbarger. I just found those e-mails. I don't have a better answer. Mr. Dingell. When were you first asked to search for documents relative to this committee's request? When did you deliver the e-mails and to whom? Please answer the question. Mr. Highbarger. Early August. Mr. Dingell. Mr. Chairman, we will submit a letter to the witness requesting more specific answers as to when, what was submitted and why. Now, Mr. Highbarger, since you were charged with the responsibility of analyzing the submissions relative to the question of carbon monoxide meat, why do none of your e-mails reflect any analytical work from you or the colleagues that were asked to also opine on the submissions? Please tell me why. Mr. Highbarger. Because there was no analysis to discuss. It was simply do you have any questions about the validity of the studies, and does it cover the entire--does it encompass it. Mr. Dingell. So you're saying you did no analysis; is that what you're telling me? Mr. Highbarger. My scientific reviewers reviewed the data submitted. Mr. Dingell. I find myself curious. How do you come to a decision at Food and Drug if you don't analyze those questions? Mr. Highbarger. It's not me, personally, who is doing the analysis. We have a team of scientists who are reviewing the data. At the end of the period of time, they tell us. We have no questions about the submission. Mr. Dingell. All right. Let me ask you this: You have produced no records whatsoever from that group to this committee, have you? Mr. Highbarger. Just e-mails that I sent you. Mr. Dingell. Are there such records? Mr. Highbarger. I would have to talk to my reviewers to see if they have any. I don't know. Mr. Dingell. You have been requested to deliver those records; have you not? Mr. Highbarger. I've delivered everything that I have found so far. Mr. Dingell. You have delivered everything that you have found so far. Is this to have us believe, then, that we have everything that is in Food and Drug's files, and, if you submit nothing more, that there is nothing more to support the decision of Food and Drug? Is that right? Mr. Highbarger. We are continuing to look for additional data. Mr. Dingell. You're continuing to look. OK. Now, kind of inform me. Has Food and Drug ever come to a decision on the application with regard to the carbon monoxide and its use in the packaging of meat and fish products? Is there a formal ruling or some action that has been taken, Dr. Tarantino, by Food and Drug? Ms. Tarantino. There is not a formal ruling or action. What we did was respond to those who made their own GRAS determination as to whether we had a concern. Mr. Dingell. So you essentially took no action; is that right? Ms. Tarantino. That's right. Mr. Dingell. And the folks in the industry are now out busy using this device without any formal ruling by Food and Drug; is that right? Ms. Tarantino. That's correct. Mr. Dingell. That's rather curious, isn't it? Is that the regular practice at Food and Drug just to hold a proceeding, arrive at no decision, and then let everybody do what they want to do? Ms. Tarantino. If a substance is GRAS under its conditions of use, they may use it without a formal ruling from FDA. That is correct. Mr. Dingell. Do you have any opinions by the lawyers at the Food and Drug or at the Department of Health and Human Services saying that this is the proper procedure for Food and Drug to take in this matter? Ms. Tarantino. The GRAS notice procedure has been reviewed by attorneys, yes. Mr. Dingell. What rulings do you have from the lawyers saying that this is a proper procedure for Food and Drug to take? Ms. Tarantino. Well, the attorneys reviewed the proposal that we published in 1997. Mr. Dingell. The attorneys reviewed the proposal, but the attorneys, what did they do after they had reviewed the proposal? Did they say this is proper or not proper? Ms. Tarantino. We published the proposal, so it was with their concurrence, yes. Mr. Dingell. Did they say it was proper? Ms. Tarantino. Yes. Mr. Dingell. Do you have a written opinion on that from the attorneys? Ms. Tarantino. We have their sign-off on the proposal from 1997. Mr. Dingell. The sign-off. What does that mean? Ms. Tarantino. They concurred. Mr. Dingell. Why did the attorneys not come forward with a written finding on this? They did not come forward with any written finding. They just signed off. What does that mean? Ms. Tarantino. The proposal laid out what we were planning to do as to how we would run a program for doing GRAS notices, for reading GRAS determinations. Mr. Dingell. Has this matter ever been finalized? Has there ever been a final order by Food and Drug on this matter? Ms. Tarantino. We're working on that. Mr. Dingell. Now, how long has it been that you have been working on it? Ms. Tarantino. Too long. The proposal was issued in 1997. Mr. Dingell. How long has it been that this process has been used? Ms. Tarantino. Almost 10 years. Mr. Dingell. Ten years. You're still working on it? Ms. Tarantino. We're working on finalizing the regulations that would underpin the proposal. Mr. Dingell. When do you expect to have the matter finalized? Ms. Tarantino. I can't answer that. Mr. Dingell. What comments have you received from consumer groups on this matter? Ms. Tarantino. We certainly received comments. I don't know. I would have to go back and look at the comments from consumer groups. Mr. Dingell. Do you have a formal record to support the findings? Ms. Tarantino. We have an open docket with the comments, and we have a record that supports the proposal. Mr. Dingell. Do you have an opinion from your attorneys that this complies with the requirements of the Administrative Procedures Act? Ms. Tarantino. The GRAS proposal? Yes. Mr. Dingell. Do you have an opinion that says that it's proper for them to proceed, to continue, under the process they have with regard to the carbon monoxide gas being used in packaging without formal approval by the Food and Drug? Ms. Tarantino. Not specifically about the meat packaging, no. Mr. Dingell. Well, Mr. Chairman, it looks like Food and Drug is in need of reform, and I guess we're going to have to give it. Thank you, Mr. Chairman. Mr. Stupak. Thank you, Mr. Dingell. Mr. Whitfield. May I just do a quick follow-up here. Mr. Stupak. Sure. Mr. Whitfield. Dr. Tarantino, just to make sure I understand this, in 1997, the Congress passed the Food and Drug Administration Modernization Act of 1997, which created a notification procedure for food contact substances; is that correct? Ms. Tarantino. That's correct. Mr. Whitfield. Under that law, the FDA has three methods to adopt a substance as GRAS. One, you can list the substance in your own regulations; is that correct? Ms. Tarantino. Yes. That has nothing to do with the food contact substance part, but go ahead. Mr. Whitfield. OK. All right. Well, on the approval of the GRAS substances, let me talk about that. You can adopt that yourself in your own regulations? Ms. Tarantino. Right. Mr. Whitfield. Or you can rely on industry self- determination of the substance. Ms. Tarantino. Correct. Mr. Whitfield. Or you can make this substance the subject of a GRAS notice. Ms. Tarantino. Correct. Mr. Whitfield. Those are the three options available; is that correct? Ms. Tarantino. Correct. Mr. Whitfield. OK. I have no further questions. Thank you. Mr. Stupak. Hearing nothing further from the Members, this panel will be dismissed. Thank you. Mr. Stupak. Our second panel of witnesses will be Mr. Mike Picchietti, the president of Regal Springs Trading Company and a member of the American Coalition for Tilapia; Ms. Nancy Donley, president of the S.T.O.P. Organization, which stands for Safe Tables Our Priority; and Ms. Wenonah Hauter, executive director of the organization of Food & Water Watch. 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 have counsel? The witnesses have indicated not. Therefore, I will ask you to please stand and to raise your right hands to take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect all witnesses answered in the affirmative. They are now under oath, including with their opening statements. We will go with Mr. Picchietti for your opening statement for 5 minutes. Your full statement will be part of the record. STATEMENT OF MIKE PICCHIETTI, PRESIDENT, REGAL SPRINGS TRADING COMPANY MEMBER, AMERICAN COALITION FOR TILAPIA, BRADENTON, FL Mr. Picchietti. Thank you, Chairman Stupak, Ranking Member Whitfield and members of the subcommittee, for the opportunity to testify regarding the consumer deception with tilapia fish that have been artificially colored using carbon monoxide. Throughout the United States, frozen carbon monoxide-gassed tilapia fillets are routinely being removed from import packaging and placed into fresh seafood counters to be thawed out and sold as refreshed or previously frozen or simply, unethically, as fresh tilapia fillets. The misidentification and the total lack of identification of carbon monoxide as an ingredient is now widespread for tilapia, and from what I've learned today, there is no ``use by'' date in the fresh counters at all. The issue that unites this group of competitors, our ad hoc coalition, that produces approximately 80 percent of fresh tilapia fillets for the U.S. market is the impact that carbon monoxide-gassed tilapia is having on our businesses and on the potential of long-lasting harm on the current positive image that tilapia has on the market. We are here today because of our concern in losing the trust and confidence for tilapia with the American consumer because of this disguised practice of keeping the knowledge of carbon monoxide as an ingredient from the consumer. What concerns us is that the American consumer is not aware of what they are buying and eating. How could they be if it is not labeled? Most Americans realize that carbon monoxide is a very common poison, and therefore, using it as an ingredient is alarming. According to the current United States National Marine Fishery Service import statistics, 125 million pounds of frozen tilapia fillets have been imported from China into the United States through August of this year. Members of the American Coalition for Tilapia estimate that at least 70 percent of this volume of product is gassed with carbon monoxide. Therefore, that's about 88 million pounds of frozen carbon monoxide-gassed fillets that have been consumed by Americans so far. That's approximately 176 million meals of carbon monoxide-gassed tilapia that have been consumed in the first 8 months of this year. To illustrate industrywide uneasiness surrounding this trade in carbon monoxide seafood products, buyers and sellers use a kind of code terminology to identify trade of the product. Names like ``cold-smoked,'' ``izumidai,'' ``sashimi grade,'' and ``CO'' are all used to identify carbon monoxide- treated product rather than using the correct name to identify carbon monoxide. At the consumer level every attempt is made to keep the identification disguised at the point of purchase. Given all the exotic names, the ingredient is nothing more than the carbon monoxide molecule. Without using CO, frozen tilapia fillets turn brown when thawed out just like fresh fillets do in the natural aging process. From a competitive standpoint, frozen tilapia fillets produced in China are much cheaper than fresh tilapia fillets produced in the Americas, frequently by as much as 75 percent less. Thawing out CO-gassed Chinese frozen tilapia fillets for sale in the fresh counter has become one of the most profitable seafood items in the category. Fresh fillets from our coalition cost more to produce and to deliver because we deliver by expensive airfreight, rushing to beat the negative impact of time and temperature on the shelf life of our product. Our products are untreated and more perishable because they are never frozen. We have to rush to maintain the red and natural fresh colors without the aid of preservatives like carbon monoxide treatments. If a vendor can simply use carbon monoxide on a cheaper product without the risk of a consumer's asking questions about the ingredient because there is no label, why buy true, fresh tilapia? We understand the right of choice and the effort of the vendors to provide value to the consumer. The cost advantage of frozen product will provide ongoing sales for Chinese tilapia. We feel Chinese frozen tilapia sales will continue to find a healthy growth without the need for using carbon monoxide. We have no problem with that. America needs low-cost fish to meet the demands of a healthy diet and the decreasing wild catch. What we find objectionable is competing on an uneven playing field against a product that is chemically enhanced and then unlabeled so the consumer will misperceive the ingredient- enhanced bright pink or red color as a sign of freshness, which is far from the truth. This deceptive practice has been going on for 10 years. The American Tilapia Association visited the Food and Drug Administration in the spring of 1998 to protest this carbon monoxide fraud. During the meeting with the FDA's Office of Seafood, arranged by the National Fishery Institute, the FDA indicated that it did not consider carbon monoxide in seafood a public health risk, but they understood that economic fraud could take place. They concluded that they did not have the manpower to enforce the law, and so the issue was one that producers would have to deal with. I was personally present at the meeting and have witnessed the development of this issue for the last 10 years. It has taken 10 years for someone inside the Government to finally ask the same questions about carbon monoxide in seafood. Following the FDA's recommendation of nearly 10 years ago, we made repeated attempts to address the issue from within the industry. In our opinion, it's clear the problem will not be solved voluntarily from within the industry. The market has grown so large and so profitable that producers using carbon monoxide are unwilling to voluntarily forego these easy profits. There is no risk since there is no enforcement or clarity on the labeling laws. It has been a domino effect. Vendors are pressured to sell these CO products to remain competitive. We believe the best way to protect the American consumer is either to legislate effective labeling or to ban this carbon monoxide use in tilapia, because enforcement has proved impossible. We fear the worst case, that the American consumer will place a blanket of distrust over all tilapia products if this carbon monoxide issue continues its disguised status. The consumer would be justified in seeking revenge against an industry that was unable to control such massive fraud. The bottom line is that this carbon monoxide GRAS approval is a passport for fraud. The wholesome image we worked so hard to establish for tilapia could be destroyed by this deceptive practice. We hope the investigations will shed light on this practice so we can find a solution before it's too late. Thank you. [The prepared statement of Mr. Picchietti follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Ms. Donley, your opening statement, please. STATEMENT OF NANCY DONLEY, PRESIDENT, SAFE TABLES OUR PRIORITY, NORTHBROOK, IL Ms. Donley. I would like to thank you, Chairman Stupak and members of the subcommittee, for giving consumers an opportunity to weigh in on a subject that is critical to our very existence, and that is the safety of our food. My name is Nancy Donley, and I am the president of S.T.O.P., Safe Tables Our Priority. S.T.O.P. Is a national grassroots, nonprofit organization whose mission is to prevent illness and death from pathogens in the food supply. Our work involves sound policy advocacy, building awareness of food- borne risk and its management, and providing victim assistance. I personally became involved in food safety after the death of my 6-year-old son Alex from E. coli O157:H7 poisoning in 1993. It is very important to emphasize that modified atmospheric packaging systems, or MAPs, have been used for years. The traditional MAP system for meat includes the use of carbon dioxide and nitrogen, which provides an antimicrobial benefit. The current debate centers on the addition of small amounts of carbon monoxide into this mix. Adding carbon monoxide creates a chemical reaction that changes the color of the meat to a very bright red. That color change is maintained indefinitely until the package is opened. This unnatural but appealing color change is the sole purpose for adding carbon monoxide into the process. The addition of carbon monoxide does not contribute any additional antimicrobial properties to its traditional MAP system using carbon dioxide and nitrogen. Meat packaged with carbon monoxide might be very unsafe, but the consumer would never question this because of its artificial bright red color. Microorganisms, including deadly pathogens, breed whenever there is a breach in the cold chain. Meat will turn brown or gray if it has been temperature-abused, something that consumers know to look for. However, meat packaged with carbon monoxide will still appear bright red and safe even after extreme temperature abuse. High pathogen levels could be present, putting the consumer at risk of serious food- borne illness. A change in color also keeps the entire food system honest. Meat processors, storage facilities, transportation carriers, and retail establishments have strong incentives to maintain the cold chain because otherwise the product is easily identified as compromised, rendering it unsalable. That safety check disappears with meat that always remains red regardless of extreme temperature abuse. Proponents of using carbon monoxide argue that consumers would be warned via an odor if the product were spoiled. We have two concerns with this. There are people with compromised olfactory senses who may not notice an off-order. Seniors often experience this, and they are one of the populations most at risk of contracting the most severe forms of food-borne illness. Odors are only detectable once the package is open, which doesn't occur until the purchaser has brought it home. The customer has the choice to return it, which is a hassle, or to throw it away. In each case the customer has been cheated. These and other factors all point to the need for labeling any meat that has been packaged using carbon monoxide. Consumers have the right to know what processes and additives have been used in the food they purchase. Full disclosure is necessary. In this case the label would need to state that carbon monoxide was used in packaging, which causes meat to artificially maintain a bright red color. It should also state that the customer must heed the ``use by'' or ``freeze by'' date listed and not rely on color, and that to do so is unsafe. Color is a tool heavily used by consumers to judge if their meat is fresh and safe. We are concerned that people will choose to eat meat that has been packaged using carbon monoxide after the ``use by'' date because they don't want to throw out what appears to be a perfectly fine-looking $10 steak; hence the need for clearly worded information to minimize this risk from happening. Lastly, I want to comment on the process used by the FDA and the USDA to grant GRAS status to meat packaged with carbon monoxide. First and foremost, we believe that this is a color additive issue that should have gone through a general rulemaking process, but, obviously, this did not happen. Regardless, the way that our regulatory agencies handle these GRAS petitions cause us deep concerns. I am neither a scientist nor a statistician, but even I can tell after looking at this study submitted to the FDA and to the USDA by the companies in support of their petitions that sound science was not used. The number of samples of ground beef used was extraordinarily small. For instance, they only used six in one study and 15 in the other. In each study all of the samples were taken from one plant at a single point in time. The temperature abuse study was done at 50 degrees Fahrenheit, which is far colder than even room temperature, and last is that the sampling was done at the point of production rather than on retail product that had passed through the cold chain. The FDA itself has acknowledged that temperature abuse is common throughout distribution and retail markets. As a consumer who relies on our Government to evaluate processes used on the foods I feed my family, I'm appalled. The FDA and the USDA need to revisit these GRAS approvals and also need to reevaluate how they accept the science of companies seeking to use new additive and food technologies. Thank you for your attention. I'll be happy to answer any questions. [The prepared statement of Ms. Donley follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. Ms. Hauter, your opening statement, please. STATEMENT OF WENONAH HAUTER, EXECUTIVE DIRECTOR, FOOD & WATER WATCH, WASHINGTON, DC Ms. Hauter. Good morning, Chairman Stupak, Ranking Member Whitfield and members of the subcommittee. I am Wenonah Hauter, executive director of Food & Water Watch. We're a consumer advocacy group located here in Washington, DC. Regrettably, we're spending more and more of our time watchdogging the Federal agencies that are supposed to be protecting our food safety. I appreciate the opportunity to participate in this hearing because we are outraged that the FDA is putting the economic interests of the industry before the health and safety of consumers. We expect industry to maximize profits. We expect the Federal agencies to protect the citizens of this Nation. Color is one of the most important factors for a consumer in determining that meat is fit to eat. In 2003, a study was prepared by the National Cattlemen's Beef Association showing that U.S. retailers lose about $1 billion each year in fresh beef sales because of discoloration, and that's what this is all about. Let's be honest. This is about making sure that consumers will buy old meat that may be contaminated. At worst, it's dangerous; at best, it's a consumer rip-off. Now, I've brought my own package of meat today, and we sat here this morning and heard that it's OK that the meat is still pink even though this meat was purchased on October 27, had a ``sell by'' date of October 31 and has been sitting out for 2 days, but we heard it was OK because there is a ``sell by'' date. This ``sell by'' date is so small that I can hardly see it with my progressive lenses, and an elderly person would not be able to see it. This is deceptive packaging. Meat that's processed within a store butcher shop and that is wrapped for display in meat cases normally has a shelf life of 4 to 5 days. Case-ready meat that's packaged with modified atmospheric packaging that doesn't have carbon monoxide has a shelf life of 10 to 12 days, but the U.S. Department of Agriculture has approved a ``use by'' date of 28 days for ground beef and 35 days for muscle cut beef that's treated with carbon monoxide. Month-old meat is not fresh, in my opinion. Now, we've heard extensively about GRAS this morning, and we agree with the other speakers on this panel. This process needs to be reviewed and changed. Second, since carbon monoxide imparts a new color to the meat that's treated, we believe that the FDA should have considered this technology to be a color additive under the Federal Food, Drug and Cosmetic Act. Third, we believe that the use of carbon monoxide for red meat products is a violation of the Federal Meat Inspection Act because the USDA is allowing adulterated products into commerce since they have not been properly approved and with the use of a color additive, and it makes the product look better or of a greater value than untreated products. Fourth, the FDA did not conduct any consumer research to determine whether there would be any issue with deception from this technology. Fifth, the USDA inexplicably reversed its position on allowing this process to be used on red meat products, which we've heard about this morning. Now, consumer organizations have done research about how consumers feel about the carbon monoxide treating of meat. The Consumer Federation of America used a public opinion research firm, Opinion Research Corporation, and they found three out of four consumers, or 75 percent, are very concerned or are somewhat concerned about the practice of adding CO to meat to make the meat appear bright red. Over three-fourths of consumers, 78 percent, said that the practice of treating red meat with CO is deceptive. In the July 2006 issue of Consumer Reports, the Consumers Union reported findings on red meat that had been treated with carbon monoxide. The Consumers Union scientists tested 10 packages of ground beef and steaks that had been treated with CO, and they found that even though the meat appeared to be red, some of the meat samples had spoiled or had bacterial counts that were close to indicating spoilage. By their ``use by'' or ``freeze by'' dates, seven samples were fresh, but two packages of ground beef from one company were spoiled. We have attached this information to our testimony, and we hope that this committee will continue investigating this. We believe that this practice should be banned. Thank you. [The prepared statement of Ms. Hauter follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Thank you. We will go to questions. Let me start with you, Ms. Hauter. You indicated you had your study done, but did you ever hear of a study where they considered consumers and how they purchase their meat products or seafood by a ``use by'' date? Are you aware of any study like that? Ms. Hauter. No, I've never heard of such a study. Mr. Stupak. Thank you. In your study, did you have any baseline to see what the respondent's knowledge was of carbon monoxide used in meat before your survey? Ms. Hauter. No. This was a Consumer Federation of America study, and as far as I know, they didn't look at this issue. In fact, I think that the reason Members of Congress are not hearing from their constituents is, I would bet, that almost no one knows about this. Mr. Stupak. In your study what was the significance of your findings? You mentioned your meat there, and on the far left-- my far left, your far right--there is actually hamburger that was just purchased here on November 10 with an expiration date of yesterday. So give me the significance of your findings of your study there. Ms. Hauter. Well, people don't want this kind of deceptive packaging, and it's by a very large percentage. Mr. Stupak. OK. Ms. Donley, you used the words ``cold chain'' in your testimony. Is that the temperature of meat and how it's processed? Do you want to explain that a little further? Ms. Donley. The cold chain is the various points along the route from production all the way through to the retailer where there has to be a cold enough temperature maintained to keep bacteria from breeding. So the chain would include warehouses and trucking companies where we're counting on all of those points to maintain that temperature, that safe temperature. Mr. Stupak. You also indicated the ``use by'' date. Do you believe that's a valid notification to consumers? Ms. Donley. No, I don't, because consumers really use their eyes to make their decisions, and there is going to be the person who is going to say, ``Hey, there must be something wrong with the date. This looks perfectly fine. I'm going to go ahead and eat it,'' who can put himself or herself at serious risk of food-borne illness. Mr. Stupak. OK. Mr. Picchietti, if I may, you were talking about tasteless smoke in your testimony, but you gave it other words. What were the other names you were using? Mr. Picchietti. Well, I wasn't talking about tasteless smoke. I was talking about industrial carbon monoxide. The other names I mentioned are---- Mr. Stupak. So are these names that have to be on packages of tilapia, these other names? Mr. Picchietti. Some of them are. Mr. Stupak. What are they? Mr. Picchietti. Izumidai, which is a Japanese word used in Japan, I guess. It signifies CO. Everyone knows. Mr. Stupak. All right. Mr. Picchietti. Cold-smoked--of which that's something else; actually, that's done to salmon, I believe, but the main thing is that's just not mentioned is ``carbon monoxide.'' Mr. Stupak. Nor would it trigger the thought in a consumer's mind that this is carbon monoxide. Mr. Picchietti. Yes. Exactly. Mr. Stupak. Let me ask them to put those pictures up. Do you want to explain the pictures that we were talking about earlier? I actually had one up, and Mr. Burgess sort of objected to it. It was the guy with the respirator who was spraying the fish. Mr. Picchietti. Well, that's just how it's done. Mr. Stupak. Let's see if we can get one of these pictures up. If you can get those up for us, because I want to ask you a couple of questions about it. OK. Here is the picture I had up before it was objected to. Could you explain what that is and what's going on there? Mr. Picchietti. Well, when the fish is filleted, they are put in like a cookie tray, and then a big plastic bag is put around it, and it's like filling up a balloon. You put the pure carbon monoxide gas, industrial gas, into the bag for an hour or so, and the hemoglobin has an affinity to it. It gets inside the hemoglobin, and it turns the fish red, actually a different color than the actual red normally. Mr. Stupak. I think we have a picture of that. We have a picture of the fish side by side. One is red and the other is-- -- Mr. Picchietti. Carbon monoxide is poisonous, so it's dangerous for the workers. In the early days---- Mr. Stupak. That's why the respirator? Mr. Picchietti. Yes, that's why the respirator. Mr. Stupak. Right here, is this--no. There's carbon monoxide, and there's naturally aged. Mr. Picchietti. Right. That would be both frozen products, the same age thawed out, and one looks like that, and that's what normal frozen would look like. Mr. Stupak. But the redness, that's brought out by the carbon monoxide? Mr. Picchietti. Yes. And you can see it's actually not even natural red; it's very heightened. So, with the discussion earlier about additive/fixative, it seems like an additive. Mr. Stupak. Now, you and your companies go with the fresh tilapia. You say that it is more expensive, of course, because you get the fish, and you've got to fly it, right, air express? Mr. Picchietti. Yes. Mr. Stupak. Where is most of your fish produced, grown? Mr. Picchietti. The coalition's fish is all from Latin and Central America. Mr. Stupak. OK. Mr. Picchietti. It's fresh because it's closer. Asia, at least now, can't fly it over. Mr. Stupak. How long would you consider the product to be fresh? How long will it last? Mr. Picchietti. Oh, 10 to 14 days from harvest. Mr. Stupak. OK. You come in from Latin America or Central America, you said. What ports do you have to bring your tilapia into? Mr. Picchietti. Miami, Boston, Los Angeles. Mostly Miami. Our farm is only an hour and a half from Miami. Mr. Stupak. I have no further questions at this time. Mr. Whitfield for questions. Mr. Whitfield. Thank you, Mr. Chairman. I want to thank this panel for your time and for being with us this afternoon. Mr. Picchietti, in your testimony, you talked about 125 million pounds of tilapia that's imported into the country; is that correct? Mr. Picchietti. Well, as of August. Mr. Whitfield. Now, is that coming in from China, or does that include the tilapia that you all bring in from Central America. Mr. Picchietti. No, it doesn't include that. I had a graph up there which showed what we all brought in. Mr. Whitfield. OK. So the 125 million pounds is coming from Asia. Mr. Picchietti. That's just China which is about 85 to 90 percent of---- Mr. Whitfield. Do you have any idea how many millions of pounds of tilapia is consumed in the United States in a year? Mr. Picchietti. Yes. One pound per person. We surpassed cod and catfish in 2006, 350 million pounds. Mr. Whitfield. Now, to make sure that I understand, are you claiming that using carbon monoxide is a safety issue, or is it basically an unfair trading practice and deception. Mr. Picchietti. Well, I don't have all kinds of scientific data about the safety issue. Mr. Whitfield. Yes. Mr. Picchietti. What I do know is it's not labeled, and the fellow today said it has to be labeled, and it's not being labeled in the fresh case. Mr. Whitfield. When you say ``not labeled,'' do you mean used by a certain date? Mr. Picchietti. Well, basically the FDA fellow said you can use the CO tilapia as long as it has a ``use by'' date on it. Mr. Whitfield. Right. Mr. Picchietti. The other thing is at the fresh seafood counters in grocery stores, there's no ingredient label either. So those are the two issues we're objecting to, which is that we feel it should be labeled in the fresh seafood case. We never thought of the ``use by'' date. Mr. Whitfield. Yes. So, from your perspective, it's really an unfair situation because of the issues that you discuss in your testimony primarily. Mr. Picchietti. Well, it's illegal, right? That's what this fellow said today. Mr. Whitfield. Yes, it is illegal. It's on the books. So, if that's occurring, then it needs to be enforced in some way. It's an enforcement issue, right. Now, Ms. Hauter, you're the executive director of Food & Water Watch. How old is Food & Water Watch? Ms. Hauter. We're 2 years old, but we're a spin-off from Public Citizens where, for 10 years, we ran a food safety program. Mr. Whitfield. Do you have dues-paying members? Ms. Hauter. Yes, we have dues-paying members. Mr. Whitfield. Would those be companies, or would those be individuals. Ms. Hauter. We take no corporate money, just public support. Mr. Whitfield. Just donations from individuals. Ms. Hauter. Donations and foundation money. Mr. Whitfield. Yes. OK. Now, back in September 2006, in tab 26 of the booklet there, which you can look at if you want to--you don't have to--the Consumer Federation of America did a survey, and they asked consumers what are some of the issues that they used to decide which products to purchase, and the No. 1 item that they looked at in making a decision to purchase was the ``use by'' or the ``sell by'' date; No. 2 was packaging/appearance; No. 3 was smell; No. 4 was color; No. 5 was texture; No. 6 was taste. I know there has been some testimony today that the one item that consumers look at most is color, yet according to this survey conducted in September, the No. 1 issue that they looked at was the ``sell by'' date. Would you disagree with that, or are you aware of that? Ms. Hauter. I think that a ``sell by'' date is different on different kinds of products. When you, for instance, purchase milk, the ``sell by'' date is kind of up there at the top. It's large. Everybody looks at it. I think it--I know that you can't see this, but if you look at a ``sell by'' date that is so small that it's under all of the information about safe handling, people would not notice this when you pick up a---- Mr. Whitfield. So, if the ``sell by'' date would be larger, that would make it easier for you to accept? Ms. Hauter. I think it's important to have a ``sell by'' date---- Mr. Whitfield. Oh, I do, too, absolutely. Ms. Hauter. But I think it's also, for meat, that traditionally people look at the color, and I think if you were going to actually do research on this, you would have to look product by product to see how people purchase items. Mr. Whitfield. Now, in your ConsumerReports.org that you submitted earlier in tab 41, I guess, you reported that you all did limited tests on carbon monoxide-packaged meat, and you found that three out of 10 samples had gone bad within the ``use by'' date. I'm assuming you've seen this report. I would ask: Do you know if Consumer Reports tested traditionally packaged meats as well? Ms. Hauter. I'm not sure if they did or not. I can't answer that. Mr. Whitfield. Now, I understand that the shelf life of traditionally packaged meat is shorter than the carbon monoxide MAP-packaged meat. So, if that's true for the MAP carbon monoxide-packaged meat, I would think it would also, maybe, even be a worse case for the traditional package. Do you have any thoughts on that? Ms. Hauter. Could you restate that? I didn't understand. Mr. Whitfield. Well, what I said was in your report, you all point out that three out of the 10 samples of carbon monoxide-packaged meat had become contaminated prior to the ``use'' date's expiring. Ms. Hauter. Right. Mr. Whitfield. They evidently did not do any testing of traditionally packaged meat, which most studies indicate does not last as long in the shelf life as the carbon monoxide meat. So I would say that if they had been fair on this test and had tested both samples, it's more than likely that the traditionally packaged may have turned out worse than the carbon monoxide meat. Ms. Hauter. But I think, sir, with all due respect, the point is that with regular packaged meat, there will be discoloration, but with carbon monoxide-treated meat, there will not be discoloration, and so consumers won't realize that there may be contamination. The longer meat sits, and when there's bacteria on it, which there almost always is, the bacteria continues to multiply, but a consumer would not be aware of it or is likely be aware of it when the meat is still pink and pretty like this. Mr. Whitfield. Now, let me ask both you and Ms. Donley, because I know that you both are committed to this issue, and all of us are very much concerned about food safety, obviously. Do you have the names of anyone who has been sickened by spoiled meat that was masked by carbon monoxide? Ms. Hauter. Well, I think it's very difficult to determine when or how people get sick from meat, and I think we would have to go to the CDC and see if they have been able to--in the information they collect, if that's one of the questions they ask, because I'm not sure that we would be aware, when people do get sick, that it was because of carbon monoxide. Mr. Whitfield. But you're not aware of anything specifically? Ms. Hauter. I'm not aware of anything specifically. Mr. Whitfield. What about you, Ms. Donley? Ms. Donley. I'm not aware of anything specifically either, but then again, someone who had become sickened probably would not be aware either that it was from the packaging, the process by which it had been packaged, because there is no requirement even to say how it was processed, so a person wouldn't know. Mr. Whitfield. Do you all have the names of any companies or supermarkets that purposely have sold bad or spoiled meat to consumers? Ms. Donley. I can't imagine any supermarket's wanting to intentionally sell spoiled meat. It may have unknowingly sold spoiled meat, but I can't imagine anyone doing that intentionally. Mr. Whitfield. But you do feel like, if they're using carbon monoxide, that it is a deceptive practice? Ms. Donley. Definitely. Mr. Whitfield. OK. Ms. Donley, you testified about breaking the chain of refrigeration, warning that a consumer will not know by color or by the ``use by'' date whether meat has been temperature-abused at the store or elsewhere. How does a consumer know that opaque packages, such as sealed hamburger packs or wrapped sausage, have not been temperature-abused? Ms. Donley. They don't. You bring up an excellent point, and I wish that the technology would be used that shows that the temperature has been compromised. There are--I can't come up with the term right now--devices that can be used in a package that would show it. So I think it's an excellent idea that all meat contain that. Mr. Whitfield. Now, you all heard testimony earlier today about scientific studies conducted at the University of Georgia, the University of Minnesota, and Texas Tech in which the consensus was, in scientific opinion, that MAP packaging using carbon monoxide was not a safety hazard. Do you all have any scientific studies indicating that those studies are inaccurate? Ms. Donley. I don't have any studies that my organization has done of their own. I would like to say, though, that it's important to take a look at what is being compared in those studies. For instance, I know that some of the referrals that have been made to Dr. Doyle, who is a very good scientist from the University of Georgia, that what he reported on--and it's not even a published study, to my knowledge--but what he took a look at in his research centered on looking at meat that--at samples that had been wrapped in just the regular overwrap process, and he compared that to meat that had been in the MAP process using the CO. So it's really an apples-and-oranges comparison. Mr. Whitfield. But the consensus of scientific opinion is that this is not a safety hazard, and you all are not aware of any additional scientific studies that would refute that is I think what you testified to. Ms. Donley. I think we need to define here what I'm talking about as far as safety. And what I'm referring to that is that I think it--pretty much it seems to be the general consensus among the scientists that this is not an issue that is going to do something to render the meat itself unsafe. But the safety factor enters into it is how it appears to people when temperature abuse could have happened, but the act in and of itself or the process in and of itself is not unsafe. Mr. Whitfield. Mr. Chairman, I think my time has expired. Mr. Stupak. Thank you. There is a company that has labels that will turn colors if the temperature is abused. Ms. Schakowsky for questions, please. Ms. Schakowsky. I just wanted to comment on that. It is not that the CO necessarily is the defect, but that it masks other problems that may exist and may present a safety hazard. So I can't imagine a study that would show in and of itself that the CO was the problem, and that's the problem. I wanted also to mention--I wanted to respond to something Mr. Whitfield said about the ``sell by'' date or a date on a product. I think that--I'm very proud of those dates. I feel like in 1969 our little group of housewives helped to get that on there. But you look at those dates primarily when you don't have other indicators. If you're going through the meat case, and you see something that looks fine, you may be prone to buy it. When you look at the date, it is because it doesn't look right, or you can't see through it, like milk or something, I think. I wanted to--there are a couple of things. One, I wanted to comment--Mr. Picchietti--sashimi grade was another. I love sashimi, and if I saw sashimi grade--I think I have seen sashimi grade on something. I think that is a good thing because I didn't know that, that it meant that it was treated. I think those names are really deceptive. And for me, particularly sashimi grade, I had no idea. I thought it was a positive because I like sashimi. I just wanted to let you know that. So I'm agreeing with your testimony. Mr. Picchietti. I'd just like to clarify that it is a real term used for real sashimi grade products. But as in the trade and among buyers and sellers, when you say is your tilapia sashimi grade, it is usually understood that it has got industrial carbon monoxide in it. Ms. Schakowsky. Not being in the industry, in the business, I certainly wouldn't know that. I wanted to ask Ms. Donley a question. You were saying that you thought that the process was faulty, but also that had it-- were it called a color additive, that the process would be entirely different. Could you explain that? Ms. Donley. Sure. First of all, it is great to see you again, Congresswoman. If this had been determined, which we think it should have been determined, that this was a color additive, it never would have been subject to GRAS approval. It would have gone through a formal rulemaking process, and it would have been open for public comment, and that a lot--all of this--it would have fleshed out additional science. It would have fleshed out consumer concerns and been a much better process than what actually happened here. Ms. Schakowsky. In any case, I think that there ought to have been a regular rulemaking process so that there was a comment period. And I agree with you, Ms. Hauter, that people don't know--I don't know. Maybe it is a lot of men who don't shop, frankly, who are making these comments. Excuse me, guys who go to the store and actually shop. But, I think most people actually are unaware that--and I wanted to ask you about relying on industry data. If you could expand on your comments on that. Ms. Hauter. We just generally have a concern when industry data is used because they have a bias, and the questions that are asked may be different than the questions that we would ask. We think that it is generally a problem---- Ms. Schakowsky. Were you satisfied--were you here when the FDA was testifying? Ms. Hauter. I was here, and I thought that they were not able to answer the questions that they should have been able to answer. And I know from our experience--we just did a very extensive report on imported fish that we had to wait over a year to get our Freedom of Information Act request answered, and when the data came to us, it was in such poor shape that we couldn't use it and had to have it manipulated to---- Ms. Schakowsky. When it is old, it gets decomposed. Ms. Hauter. So I was not surprised. And that has been our experience and our concern about the FDA. Ms. Schakowsky. Well, this committee has asked for information. You have asked for information. The FDA has failed to act for over 10 years. So timeliness in dealing with all of these is a problem. And I also recognize the competitive issues as well. I want fresh fish. I don't want fresh-appearing fish. And you would know the difference in colors, but I wouldn't know that it is too red or not too red. I think we have to resolve this for safety and for deceptive--consumer deception reasons. Thank you. Mr. Stupak. Thank you. Ms. Donley, you were asked--Mr. Whitfield and others asked about the studies in temperature. In the exhibit book, they are exhibit 30 and 31. I had asked--and you have it right in front of you there. I asked the FDA about these studies. One was from Minnesota, the other one was Norway. The Norwegian study on page 218 says the safety of the modified atmospheric packaging, products are mostly threatened by temperature abuse. And if you go to exhibit No. 30, again that study, which is out of the University of Minnesota, says temperature abuse is a main concern for chilled and/or modified atmosphere packaging, meat and poultry products, since it will not likely cause economic loss, but may also lead to food-borne illness hazard. A major question of such products is whether spoilage due to microbial or chemical action will occur before pathogen numbers or toxic levels become a risk when a product undergoes abuse temperatures. So is that the temperature or the code part that you were talking about? Ms. Donley. Right. That is the cold chain process. And anywhere along those points, if the temperature is raised higher than what it should be to keep bacterial growth from occurring, bacteria has a way of multiplying very, very rapidly. Mr. Stupak. Let me ask this question. Ms. Hauter, you have your package there. Right there we have samples E, F and G on your extreme left and my right. Take a look at those samples. What do they look--appear to you, E, F and G? Ms. Donley. These three? Mr. Stupak. Yes, the three on the end. Ms. Donley. They look very, very fresh to me. And I think-- if I might, when we talk about these ``use by'' or ``freeze by'' or ``sell by'' dates, I think consumers look at those dates when they are making their purchase. When I go to the 7- Eleven next to my office and I buy my sandwich, I look to see when it was prepared on so I'll buy the one that was prepared most recently. The consumer buys this package of meat, sticks it in the refrigerator. When they go to use it and it looks that color, they're not even going to--it is not going to occur to them to even look to see that ``use by'' date because it looks perfectly fresh. Mr. Stupak. Ms. Hauter, do you think E, F and G look fairly fresh? Ms. Hauter. They look perfectly---- Mr. Stupak. Mr. Picchietti? Ms. Hauter. They look like they were just cut. Mr. Stupak. OK. Well, E was purchased on January 12, 2007. That is, what, 10 months ago. F was purchased 1 year and 8 months ago, and G nearly 2 years ago. Needless to say, they are temperature-abused, I take it, sitting here, and yet they are staying fresh-looking. I have no further questions. Anyone else? With that I'll thank and dismiss this panel. Thank you. I call up our third and final panel if we will for today. The panel consists of Mr. Gregory Page, CEO of Cargill, Incorporated; Mr. Jeffery Ettinger, chairman, president and CEO of Hormel Foods Corporation; Mr. Doug Brinsmade of the Anova Food, Incorporated. It is a policy of this subcommittee to take all testimony under oath. Pleased 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? Everyone indicated no. Therefore, I ask you to stand and raise your right hand. Please take the oath. [Witnesses sworn.] Mr. Stupak. Let the record reflect that all three gentlemen indicated they are under oath. We will begin with opening statements. Who would like to begin? Mr. Page, you're on my right. If you want to start, please. STATEMENT OF GREGORY PAGE, CHIEF EXECUTIVE OFFICER, CARGILL, INCORPORATED Mr. Page. Thank you, Mr. Chairman and subcommittee members. You have requested as the chief executive officer of Cargill I speak to you today about the production of meat products and Modified Atmosphere Packaging, otherwise and often referred to as MAP. We in the food science community consider this packaging to be one of the most important food safety innovations ever. Packaging innovations have a long history of improving food safety. Many advances now seem simple, canned goods, pasteurization, vacuum packaging and tamper-resistant fresh food packaging to name just a few. There was a time when the salt curing of meat was the most advanced technology available, and it performed fairly well as a critical health protection for a thousand years or more. We now know a lot more about food safety and have many, many more technologies available to help make food as safe and as accessible to consumers in ways we never imagined. Basic food science and food safety principles have evolved. And these principles direct some of the most critical research and innovation of our product offerings. We know the importance, for instance, in prohibiting cross-contamination. We know about the importance of controlling temperature and moisture, of controlling the oxygen and the interior atmosphere of a package, and of controlling the pH. We also know that processing technology, preservatives and additives play a critical role in consumer protection. Consumer demands and scientific knowledge also direct research and innovation. Today's consumers want a wide variety of perishable items, including produce, fish and meat. They often want products that can be labeled as natural or organic. And they want these items to be available at their local stores year round, 24 hours a day for their convenience. It is this drive to safely satisfy consumer demand that leads us to the technologies of today. Scientists have long known the importance of controlling the interior atmosphere of food packages, and one of the earliest applications of modified atmosphere packaging was in 1927 when storing apples in an atmosphere of reduced oxygen and increased carbon dioxide resulted in increased shelf life. The early understanding and use of gas mixtures led us to the case-ready systems available today. Beef is typically delivered to a grocery store in one of three ways, as a box product sealed in a vacuum package, or as individual packages with high oxygen or low oxygen-modified atmosphere packages ready for display in the meat case for consumer purchase. Boxed, vacuum-packaged product is opened at the grocery store and cut into steaks or roasts and then wrapped in the store for retail display. Case-ready products come completely packaged and labeled and can be taken from a line box and placed immediately in the retail display. The case-ready system eliminates the need to open, handle and repackage the product in the store and greatly reduces the chance of cross- contamination. We want consumers to have all the benefits of these advanced packaging systems. We believe it unfortunate that there has been misinformation about low-oxygen MAP. We have seen some retail customers who have found this technology serves them and their customers best find the need to back away from it because of public pressure. We recently had the opportunity to host investigators from this committee at one of our case-ready plants. We as a company learned clearly from our guests the important issue concerning the committee members was the potential that a consumer may not fully understand that color is not the only indicator of freshness. For this reason we will be adding wording to our labeling, pending, of course, USDA approval, to include the following statement: ``Color is not an indicator of freshness. Please refer to `use' or `freeze by' dates.'' We believe this effectively addresses the concerns expressed by the committee visitors to our plants regarding the protection of public health, while not undermining the adoption of the safety and the convenience afforded through this case-ready packaging technology. We stand firmly by our previous statements that color is not a proper indicator of freshness or safety, and we support the FDA's and the USDA's decisionmaking. While there are many foods like eggs, ketchup, salad dressing and carrots that all maintain their coloration, only observing freshness dates will tell you when the products are past their peak of flavor or quality. My point is this: science should guide our regulatory decisions. Consumers suffer a great disservice when competitive pressures drive a debate that leads consumers away from the superior food safety and freshness performance inherent in the packing we are discussing today. I'm sure the individuals in the salted meat industry were discouraged when new innovations led to canning and ultimately packaging, and I'd relate a story specific to meat. In 1904, a guild of more than 600 butchers in San Francisco formed the Butchers Board of Trade, And the purpose of their organization was to oppose the adoption of ammonia-based mechanical refrigeration, which was newly being introduced at that time. Their self-serving opposition would have prolonged the continued unsanitary use of block ice to chill meat. In fact, at that time people resisted this pressure, and the adoption of mechanical, rapid refrigeration of meat was adopted, to the great benefit of consumers. Cargill is deeply committed to serving the needs of our customers. The low-oxygen technology that we've discussed today is an important evolution in packaging and is but one example of our commitment. I'd like to thank this committee for its commitment and leadership in the area of food safety. I want to recognize the work of the committee staff and would be pleased to answer any of your questions to the best of my ability. Thank you. [The prepared statement of Mr. Page follows:] Testimony of Gregory Page Thank you Chairman Stupak and subcommittee members. You have requested that as the chief executive officer of Cargill I speak to you today about the production of meat products in Modified Atmosphere Packaging--known as MAP. We, and the food science community consider this packaging to be one of the most important food safety innovations ever. My testimony today has been crafted with a great deal of input from our research and development leaders, and since I am not a scientist, I will be relying on their expertise for any questions of a scientific nature. Food Packaging Innovations Packaging innovations have a long history of improving food safety. Many advances now seem simple--canned goods, pasteurization, vacuum packages, and tamper resistant fresh food packaging, just to name a few. There was a time when the salt curing of meat was the most advanced package available, and it performed fairly well as a critical health protection for a thousand years or so. We now know a lot more about food safety and have many, many more technologies available to help make food as safe and accessible to consumers in ways never before imagined. Basic food science and food safety principles have evolved, and these principles direct some of the most critical research and innovation of our product offerings. We know the importance of prohibiting cross contamination. We know about the importance of controlling temperature and moisture, of controlling the oxygen and interior atmosphere of a package, and controlling pH. We also know that processing technology, preservatives and additives play a critical role in consumer protection. Consumer demands and scientific knowledge also direct research and innovation. Today's consumers want a fresh and wide variety of perishable items including produce, fish and meat. They often want products that can be labeled as natural or organic. And, they want these items to be available at their local stores, year-round, for their convenience. It is this drive to safely satisfy consumer demand that leads us to the technologies of today. Packaging Gases, Food Products, and Food Safety Scientists have long known the importance of controlling the interior atmosphere of food packages. One of the earliest applications of Modified Atmospheric Packaging (MAP) was in 1927, when storing apples in an atmosphere of reduced oxygen and increased carbon dioxide resulted in increased shelf life. In the 1930s a modified atmosphere was used in the storage and transportation of fruit in the holds of ships, and increasing the carbon dioxide concentration surrounding beef carcasses transported long distances was shown to increase shelf life by up to 100%. Today, nitrogen is probably the most widely used gas in food packaging. Nitrogen is often used as the principle gas to flush oxygen out of packages that will be vacuum packed. The Food and Drug Administration and the United States Department of Agriculture have long accepted the safe use of nitrogen as a packaging gas. As previously mentioned, carbon dioxide has also been utilized as a key packaging gas. Fresh fruits and vegetables are often shipped in a mixture of gases, where the carbon dioxide level plays a key role in both suppressing microbial activity as well as helping regulate the ripening process which in turn greatly extends shelf life, and helps guarantee product safety. The careful use and application of this gas has long benefited consumers by helping the produce industry manage supplies and meet consumer demands. For perishable items, like bananas, we in the U.S. do not have the climate to produce adequate quantities to meet demand. Carbon dioxide and other packaging gases allow the American consumer to become accustomed to a perpetual supply of fresh fruits and vegetables. Without Modified Atmosphere Packaging, we would not have fresh bananas, berries or apples in winter, and packaged or organic salad greens. Much like carbon dioxide, gas mixtures containing ethylene are critical for a wide number of fresh fruits and vegetables. Ethylene promotes the ripening of apples, avocados, bananas, citrus, dates, mangos, melons, papayas, pears, pineapples and tomatoes. In the context of historical innovations, the use of carbon monoxide is relatively new. The Food and Drug Administration approved the use of this gas in 2002. It is used in combination with carbon dioxide and nitrogen, all of which have important food safety and freshness properties. Unique to the FDA approval is that we asked for, and FDA supported, the mandate that foods packaged in this format must include tamper-proof freshness dating. Modified Atmosphere Packaging and Case Ready MeatsThrough a MAP system, meat is packaged at a central processing plant and is then delivered to the retail grocery store in a tray covered with a protective film. This helps eliminate the potential for cross contamination that can come from human handling both at the retail store and in the home. The package is both leak- proof and tamper proof, adding additional consumer protections. Mr. Chairman, you have recently raised the question that MAP packaging containing CO may allow meat to retain its characteristic red coloration for too long, potentially masking spoilage. I appreciate the opportunity to help ensure that this technology is more fully understood and to convey our deep commitment to consumer protection. Today beef is typically delivered to a grocery store in one of three ways--as boxed product sealed in a vacuum packaged bag, or as individual packages with high oxygen or low oxygen modified atmosphere packages, ready for display in the meat case for consumer purchase. Boxed, vacuum-packaged product is opened at the grocery store and cut into steaks or roasts and then wrapped for retail display. Case ready products come completely packaged and labeled, and can be taken from a lined box and placed in the retail display. The case ready system eliminates the need to open, handle, and re-package the product in the store, greatly reducing the chances of cross contamination. Meat products in a vacuum bag have a shelf life of about 35 days. The shelf life of case ready products will vary depending on the packaging technology used. There are two types of case ready MAP product offerings-- those packaged in a high oxygen (high-ox) format and those in a low oxygen (low-ox) format. We believe that both are good formats, but the low-ox format, in many respects, has significantly better functionality, especially in the area of ensuring freshness and convenience for the consumer. Steaks and roasts that are packaged in a low-ox environment have a shelf life roughly equivalent to the 35 days of the vacuum bag. Steaks and roasts in high-ox packaging have a shorter shelf life of only 14 or 15 days. You can observe this shelf life concern not only in meat packaging but also in produce. As a point of reference, note that the spoilage of a head of lettuce accelerates rapidly after the packaging is removed. The technology in MAP produces a shelf life similar to packages using vacuum technology. And, it achieves this equivalent shelf life in a manner that is much more convenient and appealing to consumers. Protecting freshness and shelf life are indeed critical. Beyond preserving freshness and reducing microbial activity, low-ox packaging also protects against flavor degradation. High levels of oxygen in a high-ox packaging such as a traditional tray wrap will deteriorate the flavor of meat. Many university studies have shown that meat in a high ox package can look acceptable, but will have a significantly less acceptable flavor than low oxygen products. Low oxygen packaging helps to maintain the natural flavor of meat. There are additional benefits of low-ox packaging. By giving retailers the shelf life similar to vacuum packages in a direct to consumer format, small retail stores in both rural and very urban areas have the opportunity to offer diverse product lines. The packaging reduces waste, because retailers can make more efficient purchasing decisions. The packaging is also more tamper-proof, through the use of imprinted use-by or freeze-by instructions that cannot be removed. Oxygen and Product Color Let me cover just a little bit about the science of our packaging technology as outlined by our R&D team. One of the challenges with low oxygen packaging is that the removal of oxygen has a visual impact on meat coloration. As you may recall from high school biology, blood appears bluish when it has not been exposed to oxygen. Once exposed to oxygen, blood becomes red. This same principle also applies to meat coloration and MAP packaging. While substantial food safety benefits are attained in low oxygen packaging, a dull red to almost purplish discoloration of the product would make the product unattractive to the consumer. In contrast, the traditional grocery tray is more exposed to oxygen, and therefore it appears red. To gain the functional and appearance performance for low- ox packaging, we substitute the oxygen with other acceptable and safe gasses. One of these gasses we use involves a trace amount of carbon monoxide (0.4 percent). As previously noted, this is fully approved by the FDA, based on volumes of scientific study. As the committee is no doubt aware, many of the leading food scientists have submitted papers and testimony that show the superior freshness and food safety performance of this packaging. I want to note that with all MAP products, the packaging gas dissipates immediately once the package is opened. Once the package is opened, product degradation continues in a manner similar with other opened packaging systems. Continual Innovations in Food Safety and Packaging Technology We want consumers to have all the benefits of MAP. But to do so, the package must be as attractive as competing products in the case. We believe it unfortunate that there has been misinformation about low oxygen MAP. We have seen some retail customers who have found this technology serves them and their customers best, find the need to back away from it because of public pressure campaigns led by a Michigan-based competitor offering a different technology. As advertised, this competing technology uses a different method to inhibit oxidation, and includes a masking effect for flavor. Our technology has no such feature. We are hopeful that greater understanding of the facts will help to abate this pressure. We recently had the opportunity to host investigators from the House Committee on Energy and Commerce at one of our case ready plants. We learned clearly that the most important issue concerning committee members was the potential that a consumer may not fully understand that color is not the only indicator of freshness. For this reason, we will add wording to our labeling, pending USDA approval, to include the statement, ``Color is not an indicator of freshness. Please refer to use or freeze by dates.'' We believe this effectively addresses the concerns of the Committee in protecting public health, while not undermining the adoption of the safety and convenience offered through case ready packaging. We stand firmly by our previous statements that color is not a proper indicator of freshness or safety, and we support the FDA's and the USDA's decisionmaking. While there are many foods like eggs, ketchup, salad dressing, and carrots that all maintain their coloration, only observing freshness dates will tell you when the products are past their peak of flavor or quality. My point is this--science should guide our food regulatory decisions. A well orchestrated, but non-science based press campaign, should not. Consumers suffer a great disservice when competitive pressures drive a debate that leads consumers away from the superior food safety and freshness performance inherent in this particular packaging. I'm sure the individuals in the salted meat industry were discouraged when new innovations led to canning and ultimately vacuum packaging. However, consumers were better off, and most importantly, more safely served as innovations in food safety and preservation continued. The need for continual food safety innovations and product marketing is recognized by all of us. We want our competitors to continue to innovate. We are going to continue to innovate. We encourage our suppliers to innovate. Consumers demand it; food safety demands it; it raises the bar for everyone; and it's the right thing to do. Cargill is deeply committed to serving the needs of our customers. The low oxygen technology that we have discussed today is an important evolution in packaging technology and is but one example of our commitment. I want to thank this committee for its commitment and leadership in the area of food safety. I want to recognize the work of the committee staff. I would be pleased to answer any questions to the best of my ability, and ask that the committee allow my colleague Dr. Eilert to answer questions of science that are beyond my expertise. ---------- Mr. Stupak. Thank you. Mr. Ettinger, please. STATEMENT OF JEFFREY M. ETTINGER, CHAIRMAN, PRESIDENT, AND CHIEF EXECUTIVE OFFICER, HORMEL FOODS CORPORATION Mr. Ettinger. Thank you, Mr. Chairman, for the opportunity to testify today. There appear to be many misconceptions about our modified atmosphere packaging technology, so we appreciate the chance to explain why we believe so strongly in this product line. Our company, Hormel Foods, was founded 116 years ago on the twin principles of innovation and quality. Indeed, our reputation for quality and wholesomeness is really our most important company asset. For the past 20 years, we've dedicated considerable research to the fresh meat case for both pork and beef. As a result of this research, we contributed to the design of a low-oxygen packaging system that provides a fresher, safer product to consumers. Oxygen is the enemy of many food products, including meat, because it accelerates spoilage. Grocery stores are replete with examples of the use of modified atmosphere packaging to keep products fresh. These include potato chips, cereals, bag salads, lunch meats and shredded cheese. In the case of fresh beef and pork, our process controls the atmosphere in the package to a ratio of 64.6 percent nitrogen, 35 percent carbon dioxide and four-tenths of a percent of carbon monoxide. In our GRAS petition, we provided clear evidence that meat packed in this matter maintains freshness for up to 35 days. This technology was found acceptable by the FDA and approved by the Food Safety and Inspection Service. Our low-oxygen packaging system has received overwhelming support from the scientific community because it is both safe and beneficial to consumers. Mr. Chairman, I have 10 letters from leading scientists supporting the safety of the technology. And with your permission, I'd like to submit them for the record. Mr. Stupak. Without objection. Mr. Ettinger. Thank you, Mr. Chairman. I would like to speak now to the benefits provided to consumers by this product line. First off, it puts much more of the available shelf life in the hands of the consumer, providing the consumer with a fresher, better eating experience. Second, it is leak-proof, preventing possible contamination from raw meat in a grocery basket or the consumer's refrigerator. Third, it eliminates the potential of cross-contamination at the store. Fourth, it allows for the packaging and code dating of meat in a temperature-controlled environment under USDA inspection. And fifth, the packaging is tamper-resistant. The main area of inquiry I've heard today relates to the question are consumers being deceived by the red color. Let me first lay to rest the notion that we'd deliberately attempt to deceive consumers by, in essence, coloring bad meat to look good. All the products sold in this joint venture is branded with our Hormel brand. The last thing we would do is enter a category with new product, put our brand on it, and endanger our overall company reputation by selling bad product. We do recognize that the inclusion of carbon monoxide in the package stabilizes the color of the meat. This is why we put a ``use by'' date on the front of this product in type three times larger than normal and put another ``use by'' statement on the back. Given the extensive testing we performed, we were confident that the packaging system would be beneficial to consumers, and indeed this has been the case. This product has been in the market now for 3 years, and we've sold nearly 23 million packages of it. Every package has our 800 number on it. Every package contains a guarantee of satisfaction. This product has enjoyed one of the highest levels of consumer acceptance of any product we have recorded, and we have no documented cases of food-borne illness associated with this package. So the concern about potential color confusion is really unsupported by our real-life experience. The U.S. Government labeling authority for these products has determined that our current labeling with its prominent ``use'' or ``freeze by'' freshness date is truthful and not misleading. Nonetheless, in an effort to address the concerns about color expressed by subcommittee staff, we have offered language to modifying the proposed bill that we'd be willing to adopt, the same language Mr. Page mentioned, and that is, ``Color is not an accurate indicator of freshness. Refer to the `use' or `freeze by' date.'' In addition, we have informed the subcommittee staff about ongoing efforts we are making to improve this packaging and address long-term color change. We appreciate what the subcommittee is ultimately trying to do, protecting consumers from harm, and as a trusted American brand for 116 years, that has always been and will remain our goal as well. I would be pleased to answer any questions to the best of my ability. Thank you. Mr. Stupak. Thank you. [The prepared statement of Mr. Ettinger follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Stupak. Mr. Brinsmade. STATEMENT OF DOUG BRINSMADE, PRESIDENT AND CHIEF EXECUTIVE OFFICER, ANOVA FOOD, INCORPORATED Mr. Brinsmade. Good afternoon, Mr. Chairman and members of the subcommittee. My name is Doug Brinsmade, and I'm the president and CEO of Anova Food, Incorporated. We are a division of the Anova Food Group. The Anova Food Group is a global seafood company specializing in sourcing, processing and distributing the seafood products from worldwide sources. We supply frozen seafood products to a majority of retailers, food service distributors and restaurant chains across America under our patented process called Clearsmoke, of which Blane Olson, president of Clearsmoke, and I are the patent holders. Mr. Chairman, I'm here today as a representative of the seafood industry with 20 years of involvement in the industry and over 12 years of experience in the use of filtered wood smoke technology of which natural-occurring carbon monoxide is part of the wood-burning process. We have utilized filtered wood smoke technology under full consumer labeling mandated by the FDA since 1999. We also utilize the U.S. Department of Commerce NOAA Seafood Inspection Program. These two combined items with an outstanding corporate quality assurance program has allowed Anova to sell over 150 million portions without a single food safety issue. That is over 1,200 container shipments. The goal of filtered wood smoke technology is to produce a frozen-at-source seafood product which is then delivered safely through frozen distribution to the food service distributor, supermarket chain, restaurant chain or consumer with a level of quality that comes as close as possible to the quality of the seafood item when it is caught. Filtered wood smoke technology is considered GRAS by the U.S. Food and Drug Administration because of the longstanding food safety record of smoked food products. Our Clearsmoke branded seafood products, as well as other competitors' products, have maintained an impeccable safety record for the 9 years since the inception of the technology. Since 1999, under the FDA Import Bulletin 16B-95, the seafood industry has been mandated to label all seafood products with filtered wood smoke as processed with filtered wood smoke as a preservative for color retention. We put this label on each individual package of our fish and on our primary box the fillets come out of. We also explain the Clearsmoke filtered wood smoke process on our retail bags so that the consumer is fully aware of the process. I have brought a retail bag that fully explains our process, and I'd like to submit our retail bag and our label to this subcommittee. Industrial carbon monoxide is also used by the frozen seafood industry. It is not the choice of Anova to utilize CO, but after my 12 years of industry experience, I am willing to state that if CO is used properly, in moderation and with integrity, it can be successful. Some of the largest seafood companies in the United States successfully use industrial carbon monoxide in their seafood programs. The use of industrial carbon monoxide is also considered GRAS by the FDA. All packed seafood items containing CO must be labeled ``processed with carbon monoxide as a preservative for color retention.'' Both filtered wood smoke and CO have increased the consumption of seafood since the processes have opened up new menu and retail opportunities. This has increased the consumption of seafood which is healthy and a very important part of one's diet. We feel that the labeling that we have used in the last 9 years mandated by the FDA is consistent and in line with our food safety record. We continue to work with the FDA and the USDC to guarantee that our seafood is processed under HACCP and all labeling requirements. I'd like to clarify to the subcommittee that the term ``tasteless smoke'' is a patented process. Both Clearsmoke and tasteless smoke are filtered wood smoke processes. I want to thank the chairman and the committee for allowing Anova Food to come up and present the history of our filtered wood smoke process. Please let me know if I can answer any questions you might have. [The prepared statement of Mr. Brinsmade follows:] Testimony of Doug Brinsmade Good Morning Mr. Chairman and Members of the subcommittee. My name is Doug Brinsmade and I am the President and CEO of Anova Food, Inc. The Anova Food Group is a global seafood company specializing in sourcing, processing, and distributing seafood products from worldwide sources. Anova maintains buying offices, plants, and operating partnerships in 15 different countries within Africa, Asia, and South America. We supply fresh and frozen seafood products to a majority of retailers, foodservice distributors, and restaurant chains across Europe and America. Anova has over 100 employees worldwide and handles approximately 60 million pounds of fish a year. Mr. Chairman, I am here today to discuss a food preservation technology know as Clearsmoke. Clearsmoke is a patented, filtered wood smoke generation process used for over 8 years to preserve seafood. The goal of Clearsmoke and the Anova Food Group is to continue to provide safe, healthy seafood products to our customers. We deliver frozen-at-source seafood products to the consumer which exhibit ninety percent of the quality characteristics of a fish that's just been caught. Because of the many questions and concerns about the use of carbon monoxide and filtered smoke in seafood, I would like to start off by making the distinction that Clearsmoke is not an additive. Clearsmoke is a smoking process that incorporates only one ingredient to preserve seafood: filtered wood smoke. Filtered wood smoking is a food preservation process based on the centuries old process of wood smoking, created specifically to extend or preserve the shelf life of fresh and frozen seafood products. A naturally occurring component of all wood smoke is carbon monoxide, and as with all smoked foods, it has an effect of preventing the oxidation of colors in the seafood products we process and freeze. Filtered wood smoke (as is all wood smoke) is considered GRAS or ``Generally Recognized As Safe'' by the FDA because of the long standing food safety record of smoked products. Our technology does not use industrial carbon monoxide or commercially mixed carbon monoxide. We only use natural hickory wood chips to create smoke. Hickory is chosen because of its ability to produce a very clean smoke with lower tar output compared to softer woods. The wood chips are burned in a conventional off-the-shelf smoke generator. The resultant smoke is scrubbed and cooled to 80--F using existing standard smoke industry techniques. The smoke that is generated is first passed through a primary filter which removes all of the particulate components of the smoke, including tar, ash, and soot. This process is done by a purely passive filtration means and does not concentrate or chemically alter the natural composition of the smoke. The smoke is then passed through the secondary filter which reduces, but does not eliminate, the odor and color components of the smoke. The smoke is accumulated in an accumulation chamber and then either pumped directly to the ``smoke house'' and applied directly to the product or compressed into storage containers for later use. Warm smoke is applied to the product before it is sent into the chiller for ``sleep over'' at 0--C to 3--C. The smoking step is followed by an ozone step for bacterial and smoke odor reduction. Finally, the product is vacuum packed and quick frozen, preventing spoilage and the potential for forming histamine. The action of the smoke in this process is that of smoke preservation and not of a flavoring or color additive. There are no added chemicals, additives or preservatives of any kind used in the Clearsmoke process. What remains are the natural preservation gasses and standard phenolic compounds that are present in all natural wood smoke. As the wood smoke is applied, naturally occurring carbon monoxide (CO) in the preservation gasses is responsible for the ``locking in'' of the existing color of the product, which is maintained through the freezing process. The Clearsmoke process is similar to grilling a steak at home. If you barbeque on the grill with wood, the smoke contains, among many things, carbon monoxide. The Clearsmoke process does not increase or adulterate the color or quality of the product in any way; it simply retains the existing quality and color of the product at the time of processing and subsequent freezing. Since the development of the Clearsmoke technology preservation process, Anova Food Group has provided over 150 million portions using this technique without a single report of a food safety incident. Our Clearsmoke products are sold in some of the largest restaurant and supermarket retail accounts in the USA. One of the most important points of the process is that it allows us to deliver a frozen seafood item that is very close in quality to fresh seafood items at a fraction of the cost and with impeccable food safety. We have avoided the rigors and high risks associated with global fresh seafood transportation. As an example of the success of the utilization of Clearsmoke products by supermarket accounts, in 2004 a major supermarket, using Clearsmoke frozen tuna, planned a tuna advertisement for a summer weekend. The commercial benefits were as follows: <bullet> They were able to plan the ad 3 months in advance with a guaranteed price since the product was frozen. <bullet> The product was stocked in the stores a week prior to the sales, with backup in the local warehouse. <bullet> An advertisement for $5.99 per pound was placed in the local newspaper. The ad stated ``Clearsmoked Tuna Loins'' and the words ``previously frozen.'' <bullet> Over 40,000 lbs of tuna was sold in 5 days and a further order of 8,000 lbs was given for the next week. <bullet> There were zero complaints, zero returns, and two calls from consumers asking what ``Clearsmoke'' was. <bullet> This ad was considered extremely successful by the supermarket and there were over 100,000 happy customers. In 1999, the FDA issued an ``Import Bulletin'' No. 16B-95 to explain its policy concerning the appropriate legal status of filtered smoke and carbon monoxide to its inspectors. The bulletin indicates that when fish are treated with either compound, the fish can no longer be labeled as ``fresh.'' The use of carbon monoxide or filtered smoke is allowed to be used to preserve the color of fresh fish, but not allowed to make bad fish look good. Therefore, all imported filtered wood smoke products and carbon monoxide processed products must be labeled since filtered wood smoke and carbon monoxide are considered by the FDA to be ingredients. In addition, it states that the labeling must disclose the presence of tasteless smoke or carbon monoxide as an ingredient of the fish on the package label along with a description of its technical function. Anova Food labels all of our products and we've done so since the very beginning. We've not missed one label since 1999, when FDA issued the import bulletin. Our label reads, ``Ingredients: Tuna processed with filtered wood smoke as a preservative for color retention.'' Since our products are vacuum packaged, the labels must also state ``Remove from Vacuum Packaging before Defrosting'' and includes other handling instructions. Our consumers understand our clearly labeled products, but because FDA is concerned that the use of filtered smoke or carbon monoxide could mask the visual signs of decomposition, new laws are being introduced to protect against this. The law states that ``a food shall be deemed to be adulterated if damage or inferiority has been concealed in any manner.'' In addition, it states that ``a food shall be deemed to be adulterated if any substance has been added thereto or packed therewith so as to make it appear better or of greater value than it is.'' We oppose the use of carbon monoxide to mask any decomposition in fish. The use of carbon monoxide can be an effective means to provide the consumer with a safe product, but we agree that it must be labeled properly. We also strongly oppose any company that uses carbon monoxide to retain color, freeze the product, unfreeze the product and then claim that it's fresh. We believe if a product has been frozen, then thawed, it must be labeled as ``previously frozen.'' Clearsmoke technology is 100% safe and has been fully tested at the University of Florida. The process is FDA and USDC approved. Anova Food has embraced the inspection of all of its processing plants by the United States Department of Commerce NOAA Fisheries Inspection Program since 1999. The USDC sends competent inspectors to each of our processing plants around the world, twice per year, to verify the use of Good Manufacturing Processes, HACCP and general food safety. Over the last 5 years the USDC has built an extensive database on fish 'color' in order to specifically verify that no color adulteration is taking place under FD&C section 401(b&c). These inspectors do an excellent job for us as well as protecting the US consumer. The Clearsmoke method of preserving seafood continues to be a safe and innovative way to provide fish to millions of Americans at a time when the Federal Government is encouraging us to consume seafood at least twice a week for its many health benefits. We continue to work towards making heart-healthy seafood products more readily available. Because of the global nature of our industry, the seafood community places exceptional emphasis on the safety of the international seafood supply. Our seafood products are some of the safest items on restaurant menus and grocery store shelves today. There have been no reported illnesses of Clearsmoke imported seafood because we take pride in what we do to ensure that our products have been properly handled, stored and prepared. Thank you Chairman Stupak. I appreciate the opportunity to testify today. I look forward to answering any questions you may have. ---------- Mr. Stupak. Thank you all for your testimony. Mr. Page, Precept Foods that we've been talking about, or Precept, that is a common partnership between you--by you, I mean Cargill and Hormel, right? Mr. Page. That's correct. Mr. Stupak. And you said that science should be a controlling factor here. Should science be allowed to deceive the consumer of the product that they're about to purchase? Mr. Page. I think it has been said by Mr. Ettinger very clearly that it is no one's intention to do that. And I think the purpose of the technology clearly is to enhance food safety and the consumer's experience, both the quality of the food they eat and also the safety of it. Mr. Stupak. But it also deceives the consumer, right? Mr. Page. I don't believe--I think that is a matter of intention or motive, and it is clearly not the case. Mr. Stupak. Then why don't you tell the consumer, then, that you use carbon monoxide in your packaging; if it is not to deceive the consumer, why won't you tell them? Mr. Page. I think it is important--first of all, in the regulatory environment, that has not been the requirement. The labels have been approved. Mr. Stupak. So you're only going to do it if you're required, not if it is for the best interest of the consumer? Mr. Page. I was going to finish my answer. I think the risk in a lot of cases--there are other gases that play an important part of food safety. Mr. Stupak. But we're talking about carbon monoxide right now. My question is about carbon monoxide. Mr. Page. I understand. But I think the issue is relevant in the sense that what consumers would like to know and have is great faith in the regulatory environment that surrounds the product, not necessarily to become chemists or to be faced with packages that are cluttered with all of the information surrounding the product in agonizing detail. The important issue is around the healthfulness---- Mr. Stupak. Don't you think the consumer would want to know how the food is treated or prepared, any food? Don't you think they want to know that? Mr. Page. I don't. Mr. Stupak. You don't think they want to know that? Mr. Page. I don't think that people want to be distracted by information that is not helpful to their purchasing decision. I think we could go over a variety of things. I talked about the fact that chlorine, for instance, forms a very important part of our food safety environment. If we had brochures---- Mr. Stupak. How is not knowing---- Mr. Page. If we had a big sign over every product in the grocery store where chlorine was part of the food safety chain, it would have a detrimental effect on people---- Mr. Stupak. We're talking about carbon monoxide. How would the consumer be helped by not knowing? How is that helpful? If I don't know something, how is that helpful to me? Mr. Page. OK. If the standard is to be helped---- Mr. Stupak. You said it is helpful to the consumer. How is it helpful if I don't know what it is? Mr. Page. Do they have the context for it? It is not to disparage anybody's judgment. Mr. Stupak. So you think consumers are not sophisticated enough to make a decision? Mr. Page. I said not to disparage that, but I think from a clarification standpoint, if it does not become part of the product, I think---- Mr. Stupak. One of your customers is Target; is it not? Mr. Page. They are. Mr. Stupak. And they're willing to put on there it is carbon monoxide-treated, the ``sell'' date. Do you think they don't understand their consumers, Target consumers, are not sophisticated? What is it? Mr. Page. At this moment we're not dealing directly with Target on this specific issue. And I may want to defer to Jeff for the specific answer with regard to Target, but we have other customers where we are having the discussion about what they'd like included on the packaging that goes into their stores. Mr. Stupak. Mr. Ettinger, you wanted to put in those 10 documents there from your experts, and we accepted them. Did you ask in those experts how people chose their food, what factors went into consideration under food? Mr. Ettinger. The testimony within the letters really focuses on the food safety of the technology. Mr. Stupak. So you didn't ask them about carbon monoxide and if consumers should know? Mr. Ettinger. No, sir. That was not part of those letters. Mr. Stupak. Mr. Whitfield asked questions here from Hormel, and consumers used the following to determine wholesomeness: ``sell by'' date, packaging, smell. He went through it. Did you tell your consumers in the survey that you package your meat in carbon monoxide? Mr. Ettinger. I'm not sure that that was our survey that you're referring to. Mr. Whitfield. Mr. Chairman, actually that was a Consumer Federation---- Mr. Stupak. You're Hormel, right? Mr. Ettinger. Yes, sir. It is in a document we submitted, but it was not our survey that was conducted. Mr. Stupak. But this is what you submitted, right, to the-- -- Mr. Ettinger. Yes. Mr. Stupak. Did you tell the consumers you have carbon monoxide meat here? Mr. Ettinger. No, sir. Mr. Stupak. Do you tell your customers that you have carbon monoxide in your meat? Do you think your survey would be different if they people knew there was carbon monoxide in the meat? Mr. Ettinger. I don't know that it would. I think that the survey goes to the priority that consumers place on information that is useful for them to make decisions. Mr. Stupak. Were you here when the last panel testified? Mr. Ettinger. Yes, I was. Mr. Stupak. And they said that 75 percent of the consumers stated that they were very concerned about the practice of adding carbon monoxide to meat. Do you dispute that? Mr. Ettinger. No. I heard that testimony. Mr. Stupak. OK. Let me go to exhibit 30, which I think is right there in front of you. I've referred to it throughout. Mr. Page. Is it in this book, sir? Mr. Stupak. Yes. I'm not sure that is the right one. There are two books there. In those 10 letters you submitted, did your experts take in the microbial population of fresh meat as affected by many factors, such as the number and distribution of microbial species present at the start of the health and handling of live animals, slaughtering practices, chilling of the carcasses, sanitation, type of packaging, handling throughout distribution and storage; or were they just talking strictly about carbon monoxide? Mr. Ettinger. I don't know that they specifically looked at that, but clearly, as experts within the field of food science, they would recognize, yes, that there are varying conditions that need to be monitored. Mr. Stupak. And every one of those can affect the safety of the food, correct? Mr. Ettinger. That's correct. Mr. Stupak. And you don't feel that if anything is wrong with the handling of the food, like, say, sample G there that looks quite fresh, that your carbon monoxide doesn't mask over any microbial pathogens or agents in that fish--or, excuse me, that meat that has been sitting there for 2 years? Mr. Ettinger. You reference that that package was over 2 years old. Yes, we would have a problem with that. We would hold the companies with whom we do business on this product line. We have a contract with each one of them that they will pull products at code date. We recognized that testimony earlier today from the Government indicated that that was a critical element of this project--of this packaging being approved was that the code date had to be prominent. Mr. Stupak. Do you think that is deceptive to the consumer? Mr. Ettinger. I think that they shouldn't be consuming a product that is 2 years old. Mr. Stupak. Would you consume it? Mr. Ettinger. Absolutely not. Mr. Stupak. But yet you think adding carbon monoxide to keep it fresh-looking is OK? Mr. Ettinger. We don't add carbon monoxide to make product look fresh beyond its code date. I can explain more thoroughly---- Mr. Stupak. So why isn't that turning all brown and nasty then if it has been 2 years if it is past the code date? It has got carbon monoxide, E, F, G. Mr. Ettinger. The carbon monoxide does have a tendency to stabilize color in the meat. Mr. Stupak. That may not be the purpose of carbon monoxide, but as we can see there--it may not be your purpose when you add it, but it is the end result, is it not, in E, F and G? It looks fresh well past the code date? Mr. Ettinger. Those aren't our packages. Mr. Stupak. I know. So therefore it would appear at least to be deceptive to the average person. Mr. Ettinger. We'd be concerned if consumers are eating that product beyond the code date. Mr. Stupak. OK. Thanks. Mr. Brinsmade, you stated that you supply seafood products to retailers, distributors and restaurants across the United States and Europe. Do you sell any of your products to Europe that have been exposed to your Clearsmoke technology? Mr. Brinsmade. Yes, sir. Up until December of this prior year, we were selling Clearsmoke products in the EU. Mr. Stupak. So until December 2006? What happened? You don't anymore? Mr. Brinsmade. Yes, sir. So what occurred is that we are actually a Dutch corporation, and we had won five suits with the Dutch health authorities and proved through science that this process was actually a valid process. What then occurred was that some of the member states, specifically some of the southern states who rely on specifically tuna for their economy, felt that this was deceptive. So there was a bit of economic issues; therefore they changed legislations. We are now currently still fighting this battle in the EU. Mr. Stupak. OK. So they thought it was deceptive. So since December of last year, you can't bring it into the EU. Do you still sell your products over there without Clearsmoke? Mr. Brinsmade. Yes, we do sell fish products without Clearsmoke. Mr. Stupak. So in order to economically--economic--it is not an economic thing then. You can still make a profit and all that by selling to the EU even though you don't have Clearsmoke on your fish products, right? Mr. Brinsmade. Yes, sir. We diversified into other species of fish. Mr. Stupak. OK. What is in your Clearsmoke besides carbon monoxide that affects fish? Mr. Brinsmade. Yes, sir. You asked this question before, so I'm glad I've had the opportunity to answer this. In smoked processes, be it tasteless smoke or Clearsmoke, it is a wood- smoking process, which means we burn hickory wood. The attributes of the wood, such as phenols, which is the No. 1 ingredient that retards bacteria--you have hydrogen, you have phenols, you have nitrogen, carbon dioxide--all of those are used for the preservation of the product. And it is a process that has been going on, as we all know, for hundreds and hundreds of years. So we are smoking the product. Mr. Stupak. OK. So when I asked Mr. Kraemer the same question, you were right, when he said it was just carbon monoxide and nitrogen, there is more to it than that? Mr. Brinsmade. Much more to it, sir. Mr. Stupak. Is that what helps enhance the color, then, of the seafood? I think we have had some slides in the last testimony where the tilapia side by side, one was enhanced and much brighter. Was it the pathogens that do that, the nitrogen? What is it that---- Mr. Brinsmade. The actual--what fixes the color is the carbon monoxide component of the smoke in our smoke process. But you receive the same amount of carbon monoxide when you throw a T-bone on the grill through our process. Any time you burn anything on a grill or when you burn a table, you're getting the same levels of carbon monoxide. Mr. Stupak. OK. Mr. Whitfield for questions. Mr. Whitfield. Thank you, Chairman Stupak. Thank you all very much for being with us today and testifying on this important issue. I would like to ask this question to, I guess, Mr. Ettinger. In the first panel, Chairman Stupak referred to e- mails among employees of Hormel, and it related to an April 2004 FDA letter requesting more information. And the documents indicated that internal Hormel employees had some concerns about the samples' microbacterial counts, the stats of the studies conducted by David Rusack. And I was wondering, Mr. Ettinger, if you can tell me, were those concerns addressed, and, if so, how? Mr. Ettinger. Mr. Whitfield, that is the first I had heard of that. However Dr. Phillip Minerich, who is the head of our research and development facility, and who Mr. Rusack works for, is here today. And if the committee would like to take testimony from Mr. Minerich on that topic, he'd be very welcome to provide that. Mr. Whitfield. We appreciate that very much. Thank you. I've been a little bit perplexed about this hearing, truthfully, even though I recognize that everyone is certainly acting with the very best of motives. But we have a situation here where a process, a packaging process, using carbon monoxide has been approved by the Department of Agriculture. They have a Memorandum of Understanding with the FDA. We have a consensus of expert scientific opinion that this is a safe process. We have a package that has a date on it that it must be used by a date certain. You all have contracts with the people who purchase your meat and sell it in grocery stores that they must agree to not keep it past the ``best use'' date. And I know that being a publicly traded company, you're always obviously concerned about legal liability and everything else. And you, too, Mr. Ettinger, and Mr. Page, all of you chief executive officers are responsible for taking care of your stockholders and the public as well with the very best of products. So I would just ask you, do you have any concern whatsoever about the safety of this product for your consumers? Mr. Page? Mr. Page. I think, as I've said, the technology enhances safety. It clearly inhibits the growth of bacteria and of pathogens if they're present; that it affords the consumer the opportunity to carry products home in their shopping cart or their grocery bag into their refrigerator without the risk of cross-contamination. It enhances food safety not just in the store by eliminating this by doing it in the back room, but in the home by avoiding the cross-contamination that can take place with other packaging technologies. I think clearly it would be our intention to encourage the adoption of technologies that allow consumers to buy these products, to use them safely in their homes. Mr. Stupak. Mr. Ettinger? Mr. Ettinger. What I would add to that is we have the added benefit 3 years later of having had actual experience in the marketplace, and as I mentioned in my testimony, we've sold nearly 23 million packages of this case-ready lid-stock product. We have our 800 number on every package. It is all branded Hormel. It tends to be a high-ticket item. These are beef and pork whole muscle items in the case of the joint venture, and so if consumers have a bad experience with it, we're going to hear about it. During that entire timeframe, we've received 48 consumer calls relating to flavor or off condition of any type. We are very open to trying to address to knock the No. 48 down, and that is part of the discussions we've had with subcommittee staff where we're open to adding language to the package talking about color to see if we can make that number even lower. But clearly the experience has been that consumers are not eating bad product and are not being deceived by this technology. Mr. Whitfield. Mr. Brinsmade, did you want to make a comment? Mr. Brinsmade. No, sir. Listening to these gentlemen, I have nothing more to state. Mr. Whitfield. Now, it has been referred to a sample there is 2 years old. I'm assuming if we opened that package up, there would be a little bit of an odor. Would there? Would there be an odor in this package that is over 2 years old? Mr. Ettinger. There should be a very significant odor. Mr. Whitfield. Now, we have heard a lot today about consumer deception, and certainly there is a distinction between consumer deception and consumer acceptance. And I think your goal was to facilitate the consumer, give them an attractive product. Anybody in the business of selling food products wants an attractive package. And so your intent here was not to deceive anyone, but was to help provide consumer acceptance, I'm assuming. Was that correct? Mr. Ettinger. I think that is an element of this packaging system that is really not understood. What we're trying to do with this packaging is provide the available freshness to the consumer. I can give you an illustration of this. Our company is headquartered in Austin, MN, a small town in rural Minnesota, south Minneapolis. We basically have two major grocery stores in the town. I went to both stores on Saturday to look at what was available in terms of the fresh meat offerings in those cases. One of the stores uses the traditional overwrap method done in the store, and the typical product life left that would be available to the consumer in that store was 2 to 3 days. The other store in town sells the product line that utilizes our low-oxygen-modified packaging, and the typical available freshness to consumers in that store was 10 to 11 days. The consumer then has the opportunity to bring that product home and doesn't have to decide the first night, gee, do I grill this up now, or do I have to put it in the freezer? This provides them with the available freshness that prior to this technology was often in the back room of the store and not available to them. Mr. Whitfield. Now, one last question. I know that a petition has been filed at the FDA asking them to review the GRAS determination relating to this packaging. It was filed by a Calsak Company. Are you all familiar with Calsak Company? Mr. Page. Not intimately, but in preparing for today, I was made aware---- Mr. Whitfield. And you are aware that they use rosemary extract, and it is competing with your technology; is that correct? Mr. Page. That's what I was told, yes. Mr. Whitfield. I yield back. I have no time left. Mr. Stupak. Mr. Dingell for questions. Mr. Dingell. Thank you. Gentlemen, your testimony today has been very helpful, and I want to express to you my appreciation for your presence. First of all, I note here in the comments made by you, Mr. Ettinger, you said this Inclusion of carbon monoxide in a package does stabilize the color of meat. If improperly handled or used well beyond the ``sell'' or ``use by'' date, it is possible that it could be spoiled in the package, yet still look red. We put sell by the dates--''sell by'' dates on the front of this product in type three times larger than normal to address this. We put another ``sell by'' date on the back of the product. Then you said this Hormel will comply with any labeling of the product that is determined to be necessary and fair through the legislative or regulatory process. Then in your rather helpful comments, Mr. Brinsmade, I note you said this on behalf of yourself and your company We oppose the use of carbon monoxide to mask any decomposition in fish. The use of carbon monoxide can be an effective means to provide the consumer with a safe product, but we agree that it must be labeled properly. Gentlemen, do you all agree with those statements? Is there any disagreement on the part of anyone with those three statements? Yes or no? Mr. Ettinger. Mr. Dingell, there were quite a few statements, and I think I would be in agreement with all of them, except if you're incorporating by reference Mr. Brinsmade's statement that carbon monoxide should be on the label, I would respectfully disagree with that. Mr. Dingell. OK. Now, gentlemen, we have a little problem here. We have a situation where it is possible that if the labeling doesn't warn the consumer, that consumer is libeled by a product where decomposition or overage or the safety of the meat product is masked by the presence of the carbon monoxide treatment; is that right? Mr. Ettinger. Well, two things would have to happen for that to occur. Mr. Dingell. That is a possibility; is it not? Mr. Ettinger. Well, the consumer would have to not notice the code by date, and the store would have to violate our contract and not pull the product prior to the code by date. But it is certainly conceivable that both of those things could happen. Mr. Dingell. Hormel says this here: The inclusion of carbon monoxide in the package does not stabilize the color of meat. If improperly used or used well beyond the ``sell'' or ``use by'' date, it is possible it could be spoiled in the package and still look red. So we have then here a problem, don't we? We can--the consumer, if this is not properly labeled, can be buying overaged meat which is unsafe, which looks good, but which, when he gets it home, he'll find either it smells bad, is unpleasant to eat, or can, in fact, be unsafe. Isn't that a true statement? Mr. Ettinger. We feel that the product line provides---- Mr. Dingell. Just yes or no. Mr. Ettinger. It is possible that a consumer could bring the product home, and it would be---- Mr. Dingell. And there is no disagreement there, I think, at the table there. Now, tell me, what do we do to see to it that this is properly labeled so that the consumer gets the warning he needs, industry gets the ability they need to properly process the food, and at the same time see to it that the public interest and the public are safe because the regulation is adequate to ensure proper protection of the consumer? How do we do that? Mr. Ettinger. Due to helpful discussions we've had with subcommittee staff and a third meeting where they actually flew out to the facility at Cargill, we've had an opportunity to at least engage in dialog about some of the possible ways to address that, and we really have kind of proposed two of them. One is the additional label language that both Mr. Page and I referred to, that color and freshness--color is not--excuse me--an accurate indicator of freshness, that the consumer should refer to the ``use'' or ``freeze by'' date. Mr. Dingell. The Food and Drug--Food and Drug does not require anything be done with regard to a ``sell by'' date, do they? Mr. Ettinger. My understanding is it is not required under---- Mr. Dingell. Under regulation. And yet some of the companies, I think Hormel, has put a ``sell by'' date on there, don't you? Mr. Ettinger. Yes. All the products sold---- Mr. Dingell. And that is done out of concern for the safety of your consumer? Mr. Ettinger. That's correct. Mr. Dingell. Because you believe that that is necessary to protect them. Now, there are other companies that do not do that, aren't there? Mr. Ettinger. I know on the products that we sell through Hormel, both the joint venture and on a regular basis---- Mr. Dingell. So if that is not done, the consumer then is not protected, is he? The consumer doesn't know what the ``sell by'' date is. He buys himself a nice-looking red meat, and he finds that that consumer is perhaps put at risk because he didn't know when that had to be used or sold or frozen; isn't that right? Mr. Page. The USDA made it a condition of their approval of the use of this technology that there be a ``sell by'' date. So you said the FDA, and I think Mr. Ettinger answered correctly to that question. With the USDA the Government---- Mr. Dingell. But Food and Drug doesn't require a ``sell by'' date, nor does the Department of Agriculture, do they? Mr. Page. No. As a requirement of this technology, we're obliged to put a ``use by'' date---- Mr. Dingell. Are you required to do that? Mr. Page. It is a condition---- Mr. Dingell. Where is that in the regulation? Mr. Page. It is a condition of our approval. Mr. Dingell. I am of the view, read correctly, that there is no regulation on this, that the regulation has never been promulgated. Am I in error on that point? Mr. Page. I won't speak technically or legally to the issue of the regulation, but I do know we're not allowed to produce this product with this technology in our facility without a USDA-approved label. Mr. Dingell. This is a very good answer, sir, but it doesn't answer the question. Food and Drug does not have in place any regulation with regard to labeling or a ``sell by'' date, do they? They simply permit you to do this. And there is no published regulation. The regulation, if such has been put forward, has never had either the comments of consumers or anybody other than the industry groups; isn't that right? Mr. Page. Not to restrike a dead horse, but the letter we received back from the USDA authorizing the implementation of this packing technology excludes the specific requirement that the label must show a ``use by'' date. Mr. Dingell. See, here is my concern. The consumer is not protected. You folks don't have a clear regulation. Honest folks like the three of you sitting there at the table, you don't have a regulation you can point to. And on top of that, rascals in the industry don't have to pay to heed any regulation because there is no regulation in place. And I'm not sure how we prosecute them from misbehavior or how we protect the consumers or how we protect you from unfair competition by rascals who aren't troubled about these matters. I think we have a bad situation on our hands. Are you here to defend that situation? I find myself hard put to defend it. I think you're at risk. I think the consumer is at risk. And I think Food and Drug is not doing its job. Am I in error in my thesis on these matters? Mr. Ettinger. I really wouldn't have a comment as to the entire regulatory ambit, but we know in terms---- Mr. Dingell. Well, we have got rascals out there that are able to disregard this. They make their meat look red, they sell rotten meat, and you three, who I think are interested in doing an honest job, find yourself in a position where you're competing with folks who don't feel themselves pressured to do us right. I think that is a bad situation. So we've got you folks getting badly treated and the consumer shabbily treated. This is a bad situation. Something has got to be done. How is it that I can defend it, or, even more importantly, how is it, gentlemen, that you can defend it? Mr. Ettinger. I guess we can only rely on the regulatory experience we have had with this product. Mr. Dingell. And we have already talked about the regulatory system. And we are going to have a nice letter off to Food and Drug asking them to explain how they've complied with the requirements of the administrative procedure. And I have to say that if somebody--some reasonably intelligent lawyer were to sue Food and Drug, Food and Drug would all the sudden have a very large problem on its hands. But you, marketing your foods, if somebody gets bad meat, which is colored to be a nice pink--are going to have a very fine lawsuit on your hands. And I think this is something that we've got to address here in this committee, see to it that Food and Drug does its job, see to it that Food and Drug protects you, see that you are protected, see that the consumers are protected and that everybody is treated in a proper and decent fashion. And I don't see that today. And I wonder how it is that you're so comfortable appearing here before the committee when you're confronting a situation of this kind. Mr. Page. I want to address the regulatory environment, and certainly some of the testimony regarding the processes surrounding GRAS are not clear. But I do believe that both of our companies or all three of our companies have spent a great deal of time with our technical staff and are very comfortable with the science surrounding this packaging. Mr. Dingell. I'm not attacking your company. I'm just saying, fellows, I think you have a problem on your hands, and I think the consumer has got a problem on his hands. And I think Food and Drug is the architect of this misery, and I think we've got to see to it that Food and Drug does a better job. And we're going to dissect Food and Drug in a very nice communication in which we are going to ask them about how it is they are doing it and why it is that they are doing this. So, gentlemen, thank you for your patience with me. Mr. Chairman, members of the committee, I thank you for your courtesy to me, and I yield back the balance of my time. Mr. Stupak. Thank you, Mr. Chairman. Mr. Burgess for questions, please. Mr. Burgess. Thank you, Mr. Chairman. Let's just follow up on that for just a moment because the chairman of the full committee has said that the FDA was the architect of this misery. Let me ask you each in turn, how many cases of illness are we talking about having been caused by this type of packaging? Mr. Ettinger. Well, the packaging involved in the Precept venture all carries the Hormel brand. It carries our Hormel Foods 800 line, and we've received no documented cases of food- borne illness out of 22-plus million packages sold. Mr. Burgess. And either Mr. Page or Mr. Brinsmade, either one of you recorded any instances of illness? Mr. Brinsmade. No, sir. Out of the seafood side of the 150 million portions that we have supplied the U.S. market, we have zero food-borne illnesses. Mr. Burgess. And I'm going to assume there are no deaths that are directly attributed to this type of packaging and this technology. Is that a correct assumption? Mr. Brinsmade. Yes, sir. Mr. Burgess. What about the number of complaints? People didn't die. How many complaints have you had that people have been misled or deceived by what the focus of this investigation has been today? Mr. Brinsmade. As far as our company is concerned, we've had zero. Mr. Burgess. Mr. Ettinger? Mr. Ettinger. As I mentioned earlier to Chairman Stupak, we do have 800-line consumer information on the package, and we do get calls from our consumers on this product line and a lot of our other product lines as well. Out of the entirety of the 3 years we've been selling the product and the over 22 million packages sold, we tallied up that there had been 48 comments from consumers relating to flavor or off-condition complaints for this product line. That is a very low ratio in terms of what would be typical in the food industry. But we also recognize that we'd like that number to be zero. We'd be looking for ways to make that happen. Mr. Burgess. So 44 out of 22 million? Mr. Ettinger. That's correct. Forty-eight. Mr. Burgess. Forty-eight. And, Mr. Page? Mr. Page. None that I'm aware of. Mr. Burgess. So the architect of the misery has really not got much to show for their architecture. How do you measure--how do you measure the likelihood of deception? If deception is the issue here, Mr. Chairman, I have got to assume that is the issue here because, for the life of me, we have got no illness, no death, no complaints. We have got plenty of problems with salmonella in peanut butter and E. coli in lettuce leafs, things we legitimately should be focusing on. But how do you measure the likelihood of deception from this packaging? Has anyone done an audit to see if the consumer is, in fact, misled by the color of the food that they purchased or misled by the ``use by'' or ``freeze by'' date? Mr. Ettinger. We are not aware of any consumers that have stated specifically that they feel they were misled by it, but I think it goes beyond that. I think there has just been a general confusion about the purpose of carbon monoxide in this packaging system to the notion that the reason we're utilizing it is we are attempting, in essence, to color bad meat and make it look good. That is not the purpose of carbon monoxide in this overall packaging system. This system was introduced as a food safety enhancement. It allows us to pack case-ready product in our plant, and provide maximum available shelf life to consumers, and provide them with a tamper-proof, leak-proof package that they then can rely on in their own homes. Mr. Burgess. I appreciate the leak-proof aspect of it. Let me just ask, do you audit the store shelves to make certain that food that is beyond the ``use by'' or ``freeze by'' date is not appearing or is not maintained on the grocery shelves? Mr. Ettinger. The retailer is obviously a different company than ours. In this case and this particular product line, we do have very specific contracts in place with each retailer with whom we partner, and this has really been very significant to them. They don't typically turn over their entire meat case to a case-ready program unless we maintain certain obligations in our facilities as well. One of the other aspects that was not talked about in terms of preserving the freshness and protecting the consumer is when our product goes from our production--the production plant of the venture to the retailer, it goes in a truck that has temperature indicators in the truck to make sure that it is maintained at the proper temperature during that whole time, and then the cold chain then becomes the responsibility of the retailer. We train them in that, we audit them in that, and we make sure that that is being maintained for the consumer's protection. Mr. Burgess. So you do provide audits on the maintenance of temperature. And those trucks that you talked about that have the temperature-sensing devices, do those go to some type of recording device so that that information is maintained over time? Mr. Ettinger. Yes, we do. Mr. Burgess. Thank you. And let me just ask, Mr. Ettinger, and I apologize for not being here when you gave your oral testimony, but in your written testimony you elaborate on a new technology that Hormel is developing to address the issue of long-term color change. Can you tell us a little bit about what the technology is and how it would address some of the concerns raised by the witnesses on the consumer panel? Mr. Ettinger. One of the things I mentioned in the testimony and I have spoken to in a couple of times during the question and answers, we really feel that this product line provides many benefits to consumers, the product safety, the additional available shelf life. We recognize through our discussions with the subcommittee and the subcommittee staff that the lack of color has been a potential downside. We felt we were addressing that by putting code dating on it in three-times-larger type. And I know that in testimony earlier, they were looking at a package where they couldn't see it. I think if you look at our package, it is really very clear on both the front and the back of the package. But in addition to that, we stand ready to try to eliminate even the 48 complaints that we have received related to flavor. We want to make sure that people are not having a bad experience with this product. So we have offered to include the language relating to color, and we are working on a technology that would allow the meat, when it goes beyond code date, to turn a brown color that would be more typical of overwrapped meat in the grocery store. If we can accomplish that without compromising any of these other advantages on food safety, then we will be happy to roll that out, and we are working earnestly in that regard. Mr. Burgess. It almost brings to mind the old Mission Impossible thing. You could have a product that self-eliminated after the expiration date, but I guess that would be hard on a grocer's shelves. The chairman brought up that there was no actual rule you were following, Mr. Page. I think you tried to speak to that when you said that the USDA has made a suitability determination that is based on the labeling; is that not correct? So there actually are rules in place that you follow, rules put forward by the U.S. Department of Agriculture. Mr. Page. There was a process that was outlined to us, which we followed, to gain consensus from prominent scientists, to take that body of evidence and bring it forward. I understand from this hearing that that evidence passed back and forth between the FDA and the USDA. The outcome of their effort following some requests for additional information were a letter to our company and to our joint venture company, allowing us to begin to utilize this technology provided that we had prominent ``use by'' information for the consumer on the retail-ready package. So we experienced the regulatory administrative process and the science focusing to be quite intense. Mr. Burgess. And I appreciate the large-print edition of the ``use by'' dates that you have on there so that I don't inadvertently bring home something that's close to its expiration, because it does cause domestic problems. Mr. Ettinger, let me ask you just to finish up here--and I wasn't here when Mr. Whitfield did his questioning. Apparently, the issue came up that there was a study that Hormel had submitted to the U.S. Department of Agriculture where there were some problems with the study; is that correct? Mr. Ettinger. That is correct. Mr. Burgess. And that the U.S. Department of Agriculture relied upon this study to make their determination? Mr. Ettinger. Yes. What I testified to Mr. Whitfield was-- he brought up the e-mail exchange that was in the evidence Chairman Stupak had referred to, and I stated that I really had not been familiar with that e-mail prior to hearing it in the testimony today but that along with me today is Dr. Phillip Minerich, who is the head of our Research and Development facility and whom Mr. Rusick, who was the author of that one e- mail, worked for, and that he could explain what's going on in that e-mail if the committee would like to have that testimony. Mr. Burgess. I think it would be beneficial to the committee if we were to hear that explanation, because it was kind of left as an unresolved question. Mr. Stupak. OK. You have to stand and be sworn in. If you're going to testify, you have to be sworn in. Do you not want to be sworn in? Do you want to testify? You have to do it for the record. State your name first, please. Mr. Minerich. Phillip Minerich. Mr. Stupak. Spell it, please. Mr. Minerich. M-I-N-E-R-I-C-H. [Witness sworn.] Mr. Stupak. OK. The record should reflect the witness has been sworn in. Mr. Burgess. And I appreciate your willingness to provide us additional information. I just feel like the question was left out there not fully answered, and if you can provide us some additional information, I think that would be helpful to the committee. Mr. Minerich. Yes. I think there was some discussion about some data that was submitted to the FDA. I know Dr. Post was trying to recall a few years back what that data was, and then there was an e-mail correspondence. What this, in essence, boils downs to is the suppression of microbial growth, that this data demonstrates, really supports the agency's determination that this packaging system is safe and does not mask spoilage or odor. The data indicate that a low-oxygen, high-carbon dioxide packaging system actually does control microbial growth, and this result was later confirmed and replicated and validated through the work of Dr. Mike Doyle at the Center of Food Safety at the University of Georgia. We see this as a good thing, that this high CO\2\ environment, low oxygen environment does suppress microbial growth, not only from a spoilage perspective but also from the food safety perspective; and of all of the packaging systems that we want to deliver our products to the consumers in, we want to choose the one that delivers the most safety to the consumer with an adequate product for an enjoyable eating experience. Mr. Burgess. So your data---- Mr. Stupak. Your time has expired, Mr. Burgess. We'll go around for a second round if you want to ask more questions. Mr. Burgess. Your data would support the fact that a micro atmosphere high in carbon dioxide would, in fact, suppress that type of microbial growth? Mr. Minerich. Yes. This data did a very good job in two types of bacteria--the total plate count, which is a general microbial count, and then also in psycrophiles, which are bacteria that specifically grow under refrigerated conditions-- and our data supported that. Mr. Burgess. I thank the witness for his testimony. Mr. Chairman, I yield back. I'll have no further questions. Mr. Stupak. Mr. Minerich, let me ask you this question then, and these are questions I put forth. The microbial levels started high and ended low in your study, and the microbial counts correlated, virtually, gas formation and odor scores; is that true? Yes or no? Mr. Minerich. Looking at the data, the microbial growth really is almost stabilized. Mr. Stupak. Well, it started high, and it ended up lower. It should go up high, should it not, after time? Mr. Minerich. No, sir. This packaging system, because of its low oxygen atmosphere and its high CO\2\ atmosphere, suppresses microbial growth. Mr. Stupak. Let me ask you this then. Let's go to 71(d) if you want to go there. Now, you are actually listed on the copy list, are you not, in 71(d)? You are the ``Phil Minerich;'' is that correct? Mr. Minerich. Yes, sir. Mr. Stupak. You're Research and Development; is that right? Mr. Minerich. Yes, sir. Mr. Stupak. Who is Dave Rusick then? Mr. Minerich. Dave Rusick is a development leader who works in my department. Mr. Stupak. OK. So you're his boss. Mr. Minerich. Yes, sir. Mr. Stupak. All right. As to this e-mail we've been talking about, had you seen that e-mail before today? Mr. Minerich. I don't recall seeing this e-mail before today. Mr. Stupak. All right. I'm looking at 71(d). I'm in the e- mail now. Mr. Minerich. What page is that? Mr. Stupak. Well, it's the last two pages of the exhibit. Mr. Minerich. Yes, sir. Mr. Stupak. OK. I read earlier about Mr. Rusick's and Ms. Ann Waylan's going back and forth. Then Mr. Rusick says Thanks for the response, Ann. Believe me. We are also puzzled by the data. So he is puzzled by the data, but you are not. But this is the second time it has happened regarding micro counts, gas and color. The first time is when we made samples for the FSIS. That would be the Department of Agriculture there is something going on. I don't have the answers. It goes on, and he lays out the questions. There doesn't appear to be a clear correlation between micro counts, gas and odor. You would think the counts would be highest in packages with the most gas and odor, but that's not necessarily the case . . . Basically, however, there is a difference in the micro counts between the four treatments, which was a real surprise. I would have thought the lactate would have further retarded the bacterial growth therein. Now, ``lactate'' is an antibacterial agent, right, to keep it down? Mr. Minerich. Yes. Mr. Stupak. Then if you go on, you say It appears to me that the micro counts that you talked about remain relatively constant, as you said, across the four treatments during the three sampling periods. I could see the micro counts eventually dying off after they reached the multi millions, but data didn't come close to that. Regarding odor, we may not be checking for the right bug. Then it goes on to say I think we have to at least determine what the data tells us before we send it to lawyers, but it was forwarded on. So are you disputing Mr. Rusick then? Mr. Minerich. No. I think this is a really good example of what happens in a company such as ours where innovation is just ingrained. Ann Waylan initiated the dialog. Dave Rusick responded, saying this was very early in this technology. He has repeated a study that shows some interesting data that this is really suppressing microbial growth, and the concern with the attorneys is really--the question was at that time: Is there potential that between lactate and high CO\2\ and low CO and low oxygen that there might be some discoverable or patentable opportunity here? That's what this discussion was really around. Mr. Stupak. But it said that he had already discussed it with the USDA, that Forest Dryden may have used these--Forest Dryden is one of your workers, one of your employees? Mr. Minerich. Forest Dryden was the vice president of Research and Development before he retired. Mr. Stupak. He used the tables to discuss it with Dr. Post, who we know is with the USDA. The part that bothers us is you had questions about the studies--that's what this e-mail indicates--and this data, which is in 71(d), is the same evidence or the same data in 71(e), the next exhibit which was submitted to the USDA for your approval. That's what bothers us. The other part that bothers me is you extol the virtues of modified atmospheric packaging. And I'm not here to attack that type of packaging, and there is no doubt that there may be many benefits associated with it, but our concern is in using carbon monoxide in this type of packaging. Your testimony is that--Mr. Ettinger and Mr. Page both indicated you stated that the modified atmosphere that you use in your packaging suppresses microbial activity. However, isn't it true that the addition of carbon monoxide to this packaging process does not contribute any additional antimicrobial properties? Carbon monoxide doesn't give you any antimicrobial properties. Mr. Minerich. At the time of this study, it was unknown. That's why the curiosity. Mr. Stupak. But we know that today, in sworn testimony by Mr. Page and Mr. Ettinger, they said that it did suppress microbial activity. Mr. Minerich. Correct. Mr. Stupak. So we didn't know when we did the study, even though we submitted it to the USDA. Today, we know it doesn't provide microbial activity. Yet we testified it does produce antimicrobial activity. So who is telling whom the truth here? Mr. Ettinger. I don't know, from my testimony at least, that the carbon monoxide had anything to do with that. Carbon monoxide is used as part of the total MAP packaging system as a substitute for oxygen so that the product will turn red, just as meat products naturally turn red when they're exposed to oxygen in the back room of a retail establishment. Mr. Stupak. But carbon dioxide is chiefly responsible for antimicrobial activity, isn't it, for suppressing it? Mr. Ettinger. Yes. Mr. Stupak. Nitrogen is basically a filler to replace the oxygen, correct? Mr. Ettinger. That would be my understanding. Mr. Stupak. So then why, in your testimony, did you mention that modified atmospheric packaging here that you ought to use would suppress microbial activity? Mr. Ettinger. We believe that the complete packaging system used in a case-ready environment versus a store overwrapped product have many food safety benefits. It's all of it put together. Mr. Stupak. Then why couldn't you have just used carbon dioxide with the nitrogen and not use carbon monoxide? Mr. Ettinger. Because the product that we would then put into the retail case would be purple, and the consumer doesn't want to buy purple meat. Mr. Stupak. So what is more deceptive, the purple meat or bright red meat? Mr. Ettinger. Meat is purple in its natural state unless it's exposed to oxygen. In a regular opportunity at a grocery store, meat is shipped in a vacuum-packed package that is purple; and when it's held--it's perfectly fresh as long as it's held in a refrigerated environment, and it isn't until that product is cut open and then put into cases and exposed to oxygen that it turns red. Mr. Stupak. So let's go back to the purpose of the hearing. As I said in my opening statement, carbon monoxide does nothing to preserve the freshness of the meat or fish, true? It does nothing to preserve the freshness? Mr. Ettinger. Not by itself. Mr. Stupak. OK. Carbon monoxide does nothing to prolong the food's shelf life, does it? Mr. Ettinger. No. Mr. Stupak. Carbon monoxide doesn't make food safer, does it? Mr. Ettinger. No, not by itself. Mr. Stupak. Then what's the purpose of using carbon monoxide other than to deceive the consumer? Mr. Ettinger. Because it allows us, in combination with the packaging technology itself and the carbon dioxide in nitrogen, to provide consumers with fresher products and with enhanced food safety. Mr. Stupak. What is your 800 number? You mentioned your 800 number that consumers can call. What is it? Mr. Ettinger. It's a number that's on every package or product. Mr. Stupak. Yes. What is it? What is the number? Mr. Ettinger. Oh. Let me see if it---- Mr. Stupak. I know it's hard to read. It's so small. Mr. Ettinger. Yes, that would be my difficulty. Mr. Stupak. It's not deceptive, but---- Mr. Ettinger. I would need to borrow some glasses. Mr. Stupak. OK. You don't know it off the top of your head. Mr. Ettinger. No, I don't. Mr. Stupak. Mr. Page, do you know your 800 number? Mr. Page. I do not. Mr. Stupak. How about you, Mr. Brinsmade? Mr. Brinsmade. Yes, I do. Mr. Stupak. It's on your package, probably. Mr. Brinsmade. Could I look at it? Mr. Stupak. Sure, if it's on your iPod. I carry your 800 number on my BlackBerry. Mr. Brinsmade. I do have it, sir. I don't know it off the top of my head. Mr. Page. I'll give Hormel's, while he's looking, with your permission. Mr. Stupak. Hormel's is 1-800. Mr. Page. 523-4635. Mr. Stupak. 4635. OK. Mr. Brinsmade. I will submit my 800 number to you in a second, sir. Mr. Stupak. It's probably on your package there. It might be quicker than modern technology. Mr. Brinsmade. Actually, our 800 number is not on this package, sir. Mr. Stupak. OK. Well, just submit it. Mr. Ettinger, you indicated you had 48 complaints over thousands and thousands, but none of those people knew or complained about carbon monoxide in your meat, did they? Mr. Ettinger. No. Mr. Stupak. Because you never told them there was carbon monoxide there. Mr. Ettinger. No, but the complaints I was referring to are related to flavor or an off-condition. Mr. Stupak. Right, but now, once we know your 800 number, people can now call, who might be watching this, and voice their opinions on carbon monoxide. Would that be fair? Mr. Ettinger. Yes. Mr. Stupak. OK. Mr. Page, would that be fair if they called your 1-800-523-4635 to express their concerns? Mr. Page. Yes. Mr. Stupak. Because you guys have said you have never done any kind of studies to determine how consumers feel about it, right? Mr. Ettinger. No. That's correct. This would be an excellent environment for consumers to learn all about the advantages of the technology. Mr. Stupak. OK. Let me ask you another question, if I may, Mr. Ettinger. Mr. Ettinger. Yes. Mr. Stupak. Let me ask you this question. In your testimony and in Precept's letter to the committee, dated August 11, you stated that using carbon monoxide does not mask spoilage. ``Spoilage is manifested by changes in meat color, flavor or appearance. We know that packaged meat in atmosphere containing carbon monoxide will appear red indefinitely even if spoiled.'' In your testimony and in your letter, you stated that other spoilage indicators like odor will alert consumers that a product is spoiled even if it does not look like it. Please explain to me how the consumer can detect off-odors in sealed packages at the point of purchase. Mr. Ettinger. They would not be able to. That is one of the trade-offs of having a tamperproof/leakproof packaging, is it would diminish the amount of odor. However, it also has the added effect that, if a consumer were to take it home and open it, it has trapped in any potential spoilage odors, and so they would actually experience them much more strongly than traditional meat items. Mr. Stupak. But the point of deception is when I purchased the meat. If it's spoiled because it's hermetically sealed, I can't smell it if I wanted to in the store. Mr. Ettinger. Not at the point of purchase, but then our expectation is we would have heard about it from our consumers. Mr. Stupak. In fact, when you talked about the samples in your answers, you said you had one here, and in about 2 years, that would have a significant odor, but you can't smell it right there, can you? Mr. Ettinger. That is correct. Mr. Stupak. OK. Mr. Page, Mr. Burgess asked you about the safety and all that of carbon monoxide, but, just recently, Cargill recalled over 1 million pounds of ground beef in November, right? Mr. Page. That is correct. Mr. Stupak. Isn't it true that the last recall was for E. coli O157:H7, a particularly dangerous pathogen? Right? Mr. Page. It was. Mr. Stupak. Eleven percent of that recall, 119,000 pounds, was shipped to grocers in packages that contained carbon monoxide; isn't that correct? Mr. Page. Yes. Mr. Stupak. OK. I have no further questions. Mr. Burgess. Mr. Burgess. Yes, but just to follow up on that, the product that was shipped that had the toxigenic E. coli that also concomitantly had carbon monoxide, those two facts are true and not related. Like the carbon monoxide did not cause the E. coli. It didn't cause it to be more toxigenic. It didn't cause it to be more virulent than it would have been under normal circumstances. We really should be having this hearing about toxigenic E. coli and how it finds its way into the ground beef products that are sold in our stores. Mr. Stupak. I agree. Mr. Burgess. Instead, we're talking about a packaging component where realistically--again, I'll reiterate, there have been no illnesses, no deaths, no complaints or 48 complaints out of 22 million items sold. I agree with Mr. Ettinger completely. If you open a package that has been sealed against leakage and the micro atmosphere is escaping and you open it up and it's a bad product, you're going to know about it pretty quickly, and if you're in my family, you'd probably take it back to the grocery store and get reimbursed or an additional product dispensed. Would that not be the case, Mr. Ettinger? Mr. Ettinger. Yes, sir. Mr. Burgess. So he's familiar with my family. Look, as to this line of questioning that we've just heard, there's a lot of things that I could say. To any one of you, is it deceptive that you put nitrogen in the micro atmosphere of those packages before you seal them up in those leakproof containers? Do you feel it's deceptive to the consumer that you're not disclosing that there is nitrogen in those packages? Mr. Ettinger. No, we don't believe so. We think it has been fairly common practice to have modified atmosphere for a number of food products to enhance freshness and safety. Mr. Burgess. Well, of course, nitrogen occurs--it's ubiquitous in our atmosphere, and it's generally an inert gas as far as human and plant life is concerned and as far as the process of respiration is concerned, but carbon dioxide is not, so you're putting in 40 percent carbon dioxide. That would probably be a lethal partial pressure of carbon dioxide for any one of us if we were to breathe 40 percent carbon dioxide for any period of time. Do you disclose that? Mr. Ettinger. No, sir, because it is just in the package, and it dissipates upon opening. Mr. Burgess. Exactly. So the issue of the carbon monoxide, again, is to extend the shelf life of the product, which is clearly defined and delineated on the product that you sell on the shelves. I would be interested if there has been any type of audit done to show whether or not the product is in a timely fashion removed from the grocery shelves if it extends beyond its ``use by'' or ``freeze by'' date. There is no way that this Congress, that this committee, can ever, ever prevent a consumer from mishandling a product. That's going to happen from time to time, and it's regrettable, but we can't go into every refrigerator and every home and make certain that all the food that has a ``use by'' or a ``sell by'' date is disposed of in a proper manner. I support and encourage Mr. Ettinger to continue with that technology that would, perhaps, be an additional visual cue to the consumer that maybe this stuff has gone beyond its date. Again, short of self-inhalation or some type of warning buzzer on the package of bacon, I don't know how you would get that accomplished. Again, I'll just tell you, Mr. Chairman, that I'm a little disappointed with the hearing. There are plenty of things-- we've devoted a whole day to this. There are plenty of other things we could have done. For heaven sakes, we never had a hearing in subcommittee on SCHIP, and we've devoted a whole day to this. I'm, frankly, mystified by the behavior of the majority. I yield back the balance of my time. Mr. Stupak. Obviously, you missed the hearing on SCHIP. It was on Medicare Advantage, which we did have a very good hearing on. So this hearing is necessary for a number of reasons. Last week, Agriculture had their hearing, and they did not have very balanced panels, shall we say, when the consumer groups were not invited. Here, we've had both sides. Second, legislation pending before our committee does call for the labeling of carbon monoxide-treated packaging in meat. That's our food safety bill. We've done most of our work on inspections, all of our food safety. Seafood especially we did some hearings on earlier this year. So we've had about three or four hearings. This is right up the line, and it's an appropriate hearing. With that, let me dismiss and thank this panel for coming. Thank you for adding your testimony today. Mr. Ettinger, we'll need those 10 letters or letters you said you had by scientists, because we agreed to put that in the record. We would like to do that, please. Mr. Ettinger. Yes, sir. Mr. Stupak. So I want to thank all of our witnesses for coming today and for your testimony. I ask 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 into the record. Without objection, the documents will be entered into the record. That concludes our hearing. Without objection, this hearing of the subcommittee is adjourned. [Whereupon, at 3:30 p.m., the subcommittee was adjourned.] [Material submitted for inclusion in the record follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]