S. HRG. 110–294 FOOD SAFETY HEARING BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE ONE HUNDRED TENTH CONGRESS FIRST SESSION SPECIAL HEARING MARCH 12, 2007—VERONA, WISCONSIN Printed for the use of the Committee on Appropriations ( Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html U.S. GOVERNMENT PRINTING OFFICE 37–849 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 APPROPRIATIONS ROBERT C. BYRD, West Virginia, Chairman DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi PATRICK J. LEAHY, Vermont TED STEVENS, Alaska TOM HARKIN, Iowa ARLEN SPECTER, Pennsylvania BARBARA A. MIKULSKI, Maryland PETE V. DOMENICI, New Mexico HERB KOHL, Wisconsin CHRISTOPHER S. BOND, Missouri PATTY MURRAY, Washington MITCH MCCONNELL, Kentucky BYRON L. DORGAN, North Dakota RICHARD C. SHELBY, Alabama DIANNE FEINSTEIN, California JUDD GREGG, New Hampshire RICHARD J. DURBIN, Illinois ROBERT F. BENNETT, Utah TIM JOHNSON, South Dakota LARRY CRAIG, Idaho MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas JACK REED, Rhode Island SAM BROWNBACK, Kansas FRANK R. LAUTENBERG, New Jersey WAYNE ALLARD, Colorado BEN NELSON, Nebraska LAMAR ALEXANDER, Tennessee CHARLES KIEFFER, Staff Director BRUCE EVANS, Minority Staff Director SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES HERB KOHL, Wisconsin, Chairman TOM HARKIN, Iowa ROBERT F. BENNETT, Utah BYRON L. DORGAN, North Dakota THAD COCHRAN, Mississippi DIANNE FEINSTEIN, California ARLEN SPECTER, Pennsylvania RICHARD J. DURBIN, Illinois CHRISTOPHER S. BOND, Missouri TIM JOHNSON, South Dakota MITCH MCCONNELL, Kentucky BEN NELSON, Nebraska LARRY CRAIG, Idaho JACK REED, Rhode Island SAM BROWNBACK, Kansas ROBERT C. BYRD, West Virginia (ex officio) Professional Staff GALEN FOUNTAIN JESSICA ARDEN FREDERICK DIANNE PREECE FITZHUGH ELDER IV (Minority) STACY MCBRIDE (Minority) GRAHAM HARPER (Minority) BRAD FULLER (Minority) Administrative Support RENAN SNOWDEN (II) CONTENTS Page Statement of Senator Herb Kohl ............................................................................ 1 Statement of Dr. Patricia Verduin, Sr., Vice President, Scientific and Regu- latory Affairs, Grocery Manufacturers and Food Products Association .......... 3 Prepared Statement of ..................................................................................... 5 Statement of Thomas E. Stenzel, President and CEO, United Fresh Produce Association ............................................................................................................ 7 Prepared Statement of ..................................................................................... 10 Statement of Caroline Smith DeWaal, Director, Program on Food Safety, Center for Science in the Public Interest ........................................................... 14 Prepared Statement of ..................................................................................... 16 History of Produce Outbreaks in the United States ............................................. 16 Fall 2006 Produce Outbreaks ................................................................................. 17 Consumer Confidence .............................................................................................. 18 FDA’s Budget Problems .......................................................................................... 19 CSPI Proposal .......................................................................................................... 19 Safe Food Act ........................................................................................................... 21 Statement of Michael W. Pariza, Director, Food Research Institute, Madison, Wisconsin .............................................................................................................. 22 Prepared Statement of ..................................................................................... 25 Statement of Hon. Andrew C. von Eschenbach, Commissioner, Food and Drug Administration, Department of Health and Human Services ................ 32 Prepared Statement of ..................................................................................... 34 Guidance for Industry ............................................................................................. 37 Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables ............................................................................................................. 37 Scope and Use .......................................................................................................... 38 Definitions ................................................................................................................ 39 Personnel .................................................................................................................. 40 Building and Equipment ......................................................................................... 44 Sanitation Operations ............................................................................................. 47 Production and Process Controls ............................................................................ 51 Documentation and Records ................................................................................... 56 Traceback and Recall .............................................................................................. 57 How the FDA Works to Keep Produce Safe .......................................................... 62 FDA Fact—Fresh-cut Fruits and Vegetables Draft Final Guidance ................... 69 FDA News—FDA Issues Final Guidance for Sale Production of Fresh-cut Fruits and vegetables .......................................................................................... 69 Statement of Robert Brackett, Director, Food and Drug Administration, Cen- ter for Food Safety and Applied Nutrition ......................................................... 71 HACCP Approach .................................................................................................... 72 Imported Fruits and Vegetables ............................................................................. 73 Guidance Implementation ....................................................................................... 74 Grant Program for Research ................................................................................... 75 Mandatory Regulations ........................................................................................... 76 Rapid Response Teams ............................................................................................ 77 Research ................................................................................................................... 78 Prepared Statement of the Wisconsin Department of Agriculture, Trade and Consumer Protection ............................................................................................ 84 (III) FOOD SAFETY MONDAY, MARCH 12, 2007 U.S. SENATE, SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES, COMMITTEE ON APPROPRIATIONS, Verona, WI. The subcommittee met at 9:10 a.m., at West Madison Agricul- tural Research Center, Hon. Herb Kohl (chairman) presiding. Present: Senator Kohl. STATEMENT OF SENATOR HERB KOHL Senator KOHL. It’s a privilege to be with you and we do appre- ciate very much your taking the time, folks, to come to this hearing on food safety. I know everybody has busy schedules and I believe our topic demands some thoughtful attention and that’s exactly what we’re going to give it today. We’re also happy to have such a good gathering here this morning. I especially want to thank our witnesses. Some of you traveled all the way from Washington. We appreciate that very much. Oth- ers have traveled all the way across town. Whether you came 1,000 miles or 5, nevertheless, the important thing is to make progress on the thing that we care about very much and that’s food safety. As the chairman of the Senate subcommittee that funds our pri- mary food agencies, both the FDA and the USDA, I think we have not just an opportunity but also an obligation to turn comments and ideas into meaningful actions and accomplishments. We cer- tainly have enough scientific and intellectual heft in this room to make a difference. By way of introduction, our panels will include the Commissioner of the Food and Drug Administration, Dr. Andrew von Eschenbach, the Director of the FDA Center for Food Safety and Applied Nutri- tion, Dr. Bob Brackett. Dr. Brackett, I’m happy to say, is returning to his home roots. He is a Wisconsin native and a UW graduate. We also have with us Dr. Pat Verduin, the Senior Vice President of Scientific and Regulatory Affairs for the Grocery Manufacturers and Food Products Association; Mr. Tom Stenzel, President and CEO of the United Fresh Produce Association, which represents growers, shippers and packers for fresh vegetables and produce; Ms. Caroline Smith DeWaal from the Center for Science in the Public Interest, a group representing consumers and finally; Dr. Michael Pariza, the Director of the Food Research Institute, which is located right here in Madison. Before we get underway, I’d also