U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

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

49–369 PDF 2008

CONTAMINATED FOOD: PRIVATE SECTOR 

ACCOUNTABILITY 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

FEBRUARY 26, 2008 

Serial No. 110–92 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

CONTAMINATED FOOD: PRIVATE SECTOR ACCOUNTABILITY 

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

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

49–369 PDF 2008

CONTAMINATED FOOD: PRIVATE SECTOR 

ACCOUNTABILITY 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

FEBRUARY 26, 2008 

Serial No. 110–92 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan,Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS,Chief of Staff 

GREGG A. ROTHSCHILD,Chief Counsel 

SHARON E. DAVIS,Chief Clerk 

DAVID L. CAVICKE,Minority Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan,Chairman 

DIANA DeGETTE, Colorado 

CHARLIE MELANCON, Louisiana 

Vice Chairman 

HENRY A. WAXMAN, California 

GENE GREEN, Texas 

MIKE DOYLE, Pennsylvania 

JAN SCHAKOWSKY, Illinois 

JAY INSLEE, Washington 

JOHN D. DINGELL, Michigan(ex officio) 

ED WHITFIELD, Kentucky 

Ranking Member 

GREG WALDEN, Oregon 

MIKE FERGUSON, New Jersey 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas(ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Bart Stupak, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 1 

Prepared statement .......................................................................................... 5 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 8 

Prepared statement .......................................................................................... 9 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 10 

Prepared statement .......................................................................................... 12 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 12 

Prepared statement .......................................................................................... 13 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 15 

Prepared statement ..........................................................................................

Hon. Tim Murphy, a Representative in Congress from the State of Pennsylvania, opening statement .................................................................................... 16 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 17 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 18 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 179 

Hon. Jan Schakowsky, a Representative in Congress from the State of Illinois, prepared statement ..................................................................................... 180 

WITNESSES

Michael Greger, M.D., Director of Public Health and Animal Agriculture, 

The Humane Society of the United States ......................................................... 19 

Prepared statement .......................................................................................... 22 

John A. Williams, Executor Director, Southern Shrimp Alliance ....................... 61 

Prepared statement .......................................................................................... 63 

William D. Marler, Esquire, Marler Clark LLP PS .............................................. 74 

Prepared statement .......................................................................................... 78 

Gary M. Rodkin, Chief Executive Officer, Conagra Foods, Inc. ........................... 104 

Prepared statement .......................................................................................... 105 

B. Keith Shoemaker, President and CEO, Butterbal, LLC .................................. 108 

Prepared statement .......................................................................................... 110 

Christopher D. Lischewski, President and CEO, Bumble Bee Foods, LLC ........ 112 

Prepared statement .......................................................................................... 113 

Rick Ray, President and CEO, New Era Canning Company ............................... 115 

Prepared statement .......................................................................................... 118 

David A. DeLorenzo, President and Chief Executive Officer, Dole Food Company, Inc. .............................................................................................................. 122 

Prepared statement .......................................................................................... 124 

Answers to submitted questions ......................................................................

David A. Eisenberg, Chairman, ANRESCO Laboratories .................................... 129 

Prepared statement .......................................................................................... 132 

Robert E. Brackett, Ph.D., Senior Vice President and Chief Science and 

Regulatory Affairs Officer, Grocery Manufacturers Association ...................... 141 

Prepared statement .......................................................................................... 142 

Page

IV 

SUBMITTED MATERIAL

Chart entitled ‘‘Seafood Recall List’’ ...................................................................... 183 

Chart entitled ‘‘School Districts Given Recalled Meat’’ ........................................ 188 

Subcommittee exhibit binder .................................................................................. 194 

(1) 

CONTAMINATED FOOD: PRIVATE SECTOR 

ACCOUNTABILITY 

TUESDAY, FEBRUARY 26, 2008 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:00 a.m., in room 

2322 of the Rayburn House Office Building, Hon. Bart Stupak 

(chairman) presiding. 

Members present: Representatives Stupak, DeGette, Doyle, Schakowsky, Inslee, Dingell (ex officio), Shimkus, Walden, Murphy, 

Burgess, Blackburn and Barton (ex officio). 

Staff present: Scott Scholegel, David Nelson, Kevin Barstow, 

Richard Wilfong, John Sopko, Kyle Chapman, Alan Slobodin, 

Krista Carpenter, Whitney Drew. 

OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr.STUPAK. This meeting will come to order. 

Today we have a hearing entitled ‘‘Contaminated Food: Private 

Sector Accountability.’’ Each member will be recognized for a five 

minute opening statement. I will begin. 

Today we hold the fifth subcommittee hearing on the safety of 

our Nation’s food supply. Although it was purely coincidental that 

this hearing was set before the largest beef recall in American history. It is not a coincidence that recalls of this magnitude are escalating. Since starting our investigations Americans have witnessed 

one food safety disaster after another. In the last 18 months alone 

we have seen in August and September of 2006, E. coli in bagged 

spinach sickened 204 people and killed three. In September of 2006 

salmonella found in tomatoes sickened 183 people. In December 

2006 lettuce contaminated with E. coli at Taco Bell and Taco John 

restaurants sickened 152 people. In February 2007 Peter Pan peanut butter contaminated with salmonella sickened 425 people. In 

February and March 2007, 100 brands of tainted pet food were recalled after sickening and killing thousands of pets. In June 2007 

Veggie Booties snacks contaminated with salmonella caused 65 illnesses. In July 2007, 90 canned food products with botulism contamination were recalled after sickening eight people. In August 

2007, almost a year and a half after the last spinach E. coli outbreak, another nationwide recall of fresh spinach occurred following discovery of salmonella in test batches. In October of 2007 

frozen pot pies carrying salmonella were recalled after illnesses 

2 

were reported in 31 states. In September of 2007 nearly 22 million 

pounds of beef were recalled after E. coli contamination was found. 

And finally, just over a week ago, nearly 144 million pounds of beef 

were recalled by Westland/Hallmark Meat Packing Company after 

being determined to be unfit for human consumption. Our food 

safety system is broken. So called voluntary compliance, relying on 

the food industry to place safety before profits, does not appear to 

be working. The budgets and regulatory policies of this Administration have crippled both the Food and Drug Administration and the 

Food Safety and Inspection Service of the United States Department of Agriculture. In fact, some 76 million Americans, almost 

one out of every four Americans, are affected each year by illnesses 

from contaminated food. Since sickness from contaminated food is 

largely preventable this committee has actively pushed the public 

and private sectors to focus on preventing this epidemic. 

What have we learned so far? We found a fragmented food safety 

program suffering from willfully inadequate resources, inconsistent 

oversights, and ineffective coordination. In December the FDA’s 

own science board report noted that FDA’s Food Safety Program 

has put American lives at risk, and the FDA ‘‘does not have the 

capacity to ensure the safety of food for our Nation.’’ We have also 

learned that the problems are not just limited to the FDA. The 

once vaulted USDA seal of wholesomeness can no longer be relied 

upon to protect consumers. USDA, despite having about four times 

the food safety budget of FDA and a network of inspectors in many, 

if not all meat processing facilities, is also failing to protect Americans. Last week’s extraordinary recall of over 143 million pounds 

of beef by Westland/Hallmark Meat Packing Company follows more 

than 20 other beef recalls in the preceding 20 months. Nearly two 

meat recalls per month. My colleagues and I are fully aware that 

the product recalls by the USDA does not indicate success, rather 

each recall means that the system has failed. Recalls tell us that 

contaminated beef made it into the marketplace, restaurants, 

schools and our kitchen tables. Last fall our hearing drew attention 

to 22 million pounds of beef that was recalled that was packaged 

in carbon monoxide, deceiving consumers into thinking the meat 

was fresh, wholesome and free of contaminants. I am troubled to 

tell my colleagues that despite our investigation, and despite one 

major retailer’s request to label their meat as having been packed 

with carbon monoxide, the USDA is still refusing to allow retailers 

to label their meat as such. 

Today’s hearing focuses on the role of private industry and protecting our Nation’s food supply. Responsibility for supplying safe 

and wholesome foods does not rest solely with the government. It 

is always the food processor that has the first opportunity to ensure the safety of their product and prevent these tragic food illnesses. We intend to ask food processors what they have learned 

from the food recalls, illnesses and deaths of last year, what they 

are doing to protect the American consumer and ensure their food 

is safe. Some of the food processors whose products were recalled 

last year will testify today. Eating vegetables, such as spinach, was 

once every parent’s refrain. But as we learned last year, eating 

vegetables and spinach nearly led to the serious injury and death 

of defenseless children. Unfortunately, the problems associated 

3 

with Salinas Valley, known as America’s salad bowl, continue to 

plague us. Is America any safer today? Hopefully the CEO of Dole, 

the Nation’s largest distributor of E. coli spinach that sickened and 

killed people last year, will tell us what he is doing to stop these 

problems. ConAgra, a firm that blamed the problems relating to 

Peter Pan peanut butter on a leaky roof in testimony before us last 

April, is also back to explain why the same strain of salmonella got 

in their peanut butter jars six months after the leak was fixed. 

ConAgra still has to explain to the American people how salmonella infected its Banquet brand turkey pot pies. We also need 

to understand from ConAgra and their supplier Butterball how 

fully cooked turkey could sicken people who ate their pot pies. We 

also planned to have asked Steve Mendell, the CEO of Hallmark 

and Westland Company, to explain how he could produce and ship 

over 143 million pounds of raw and frozen beef products that the 

USDA determined was unfit for human consumption. Hallmark/ 

Westland’s February 17 recall is the largest meat recall in the Nation’s history. Fifty-five million pounds of this meat was shipped to 

feed children in federally sponsored school lunch programs. How 

could children and seniors be fed beef from cattle that could not legally be slaughtered. USDA inspectors were at the plant. Where 

were they? Why didn’t Federal inspectors catch the illegal slaughter of downer cows before millions of children were put at risk of 

mad cow disease and other health problems from eating meat from 

cows that were too sick to even stand up? 

We will also hear from the CEO of Bumblebee and New Era 

about the deadly botulism bacteria that were found in their food. 

We need to know how botulism, a very deadly but rarely found bacteria, survived the sterilization process required for low acid 

canned foods in the Bumblebee plant in Georgia and the New Era 

facility in Michigan. I believe this is the first time in over 30 years 

that botulism has been discovered in our food. If we can no longer 

trust our food companies to provide us with food that is supposed 

to be pasteurized, then America’s food safety has sunk to a new 

low. How many other foods that are supposed to be sterilized before 

they are being sent to the grocery stores, but are not being pasteurized before being sold to American consumers. 

Today we will also have more testimony of banned antibiotics 

found in imported seafood that the FDA is unable to keep off our 

tables. 

We will also have with us today a witness from a private laboratory that tests imported food for safety. We expect to learn how 

easily companies can manipulate the current inspection system to 

allow contaminated imported food into our supply. Fifteen years 

ago America’s trust in the food supply was shattered when four 

children died and more than 700 people became sick after eating 

Jack-In-The-Box hamburgers. USDA responded to this tragedy in 

1995 with creation of an industry-supported Hazard Analysis Critical Control Point, or HACCP. The HACCP system was promoted 

as a science-based strategy for protecting public health. Although 

the scientific principals of HACCP remain sound, many experts 

contend that it actually decreased Federal oversight, because of industry’s self reliance on self inspection under HACCP. 

4 

Today our food safety system is broken. The overarching question 

for the corporate CEOs testifying today is simply how do we fix our 

critical food safety net? Chairman Dingell, myself, and a number 

of our colleagues are determined to restore confidence in our food 

safety system. We need your support. I hope today is a start to correct the problems that created the litany of recalls and illnesses of 

food recalls last year. Members of this committee look forward to 

working with you in this effort. 

My opening statement is complete. Next we turn to Mr. Shimkus, 

from Illinois, for his opening statement, please, sir. 

[The prepared statement of Hon. Bart Stupak follows:] 

5 


49369.001
6 


49369.002
7 


49369.003
8 

OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr.SHIMKUS. Thank you, Mr. Chairman. As you stated today this 

hearing is fifth in a series of food safety hearings conducted over 

the past year. And the hearing brings together a number of recent 

food safety cases representing four or five distinct issues. Import 

surveillance, adherence to good manufacturing practices, the role of 

Federal guidance and mandates and enforcement of and company 

adherence to existing rules and regulations. As the hearing title 

suggests the essential theme today is private sector accountability. 

Our job today is to shine the light on these cases before us to identify whether there were any deficiencies in private sector actions, 

and to determine what changes, if any, by the regulators or the 

regulated could have prevented the outbreaks from occurring. We 

will be hearing some alarming stories about food safety practices. 

We should keep some perspective on this. According to the Centers 

for Disease Control and Prevention there are approximately 76 million food borne illnesses a year, which result in an estimated 5,000 

deaths and 325,000 hospitalizations. These numbers indicate that 

food safety regulation standards and guidelines should be reviewed 

and updated frequently and enforced to ensure that all Americans 

are eating wholesome and safe food. While any death or hospitalization is one too many, it is not so clear whether we are experiencing a significant across the board spike in food borne illness 

outbreaks compared with a decade ago. Date of last April from 

CDC surveillance showed that illnesses from consuming raw seafood, mostly oysters, have spiked well above the late 1990s. But the 

relatively low rate of salmonella and viral E. coli outbreaks, although rising in recent years, were still below the 1996 to 1998 

baseline. We should nevertheless be constantly vigilant for ways to 

improve our food safety regulatory system. The goal is to reduce 

the risks of food borne illnesses while maintaining the wonderful 

variety, abundance, and value of our Nation’s food supply. 

Imports are our special regulatory challenge. But technology advances are providing tools that can help address the risks domestically. Due to advances in information technology such as pulsenet 

and foodnet the CDC and the State Health Departments now have 

access to and can input surveillance data into national databases 

that monitor and track food borne illnesses. These technologies instituted in the late 1990’s serve as powerful investigative tools to 

help uncover the source of food borne illnesses and outbreaks in 

our country. Prior to these systems tracking food borne illnesses 

and tracing the illnesses back to the root sources was more cumbersome and incomplete. Now that we are doing a better job of 

tracking food borne illnesses we should work to make sure this information is put to maximum use to improve safety systems. 

This hearing focuses mainly on several companies that have produced food products that have been contaminated by harmful 

pathogens including E. coli, salmonella and botulism. These contaminants can lead to human illnesses, especially in those who are 

immune, such as children and the elderly. Our witnesses today are 

divided into two panels, but are here for one reason. We all want 

to discern what both the public and private sector can do to reduce 

the risks of food borne illnesses. I understand that the American 

9 

public wants someone to be held accountable, corporate or otherwise. However, before we can determine what should be done, we 

need to answer some fundamental questions. What is the source of 

contamination in each one of these cases? Can it ever be identified? 

Can we identify deficiencies in the company practices that would 

have prevented or would prevent this harm in the future? Would 

increased federal regulations address these deficiencies, or it is 

merely a matter of closely adhering to existing rules and practices? 

Are some of the cases representative of bad actors that violated existing regulations and need penalties enforces against them? I have 

a hunch, Mr. Chairman, that we will find today a range of answers 

depending upon the case before us. For that reason I think one of 

difficult, but useful goals of this morning is to sort out clearly for 

the Director the separate lessons we can draw from each of these 

cases. 

I look forward to the witnesses this morning, and the variety of 

perspectives and expertise. This promises to be an informative 

hearing. I yield back. 

[The prepared statement of Hon. John Shimkus follows:] 

STATEMENT OF HON. JOHN SHIMKUS

Thank you Mr. Chairman. As you stated, today’s hearing is the fifth in a series 

of food safety hearings conducted over the past year. And the hearing brings together a number of recent food safety cases, representing four or five distinct issues: 

import surveillance, adherence to good manufacturing practices, the role of federal 

guidance and mandates, and enforcement of—and company adherence to—existing 

rules and regulations. 

As the hearing title suggests a central theme today is private sector accountability. Our job is to shine a light on these cases before us to identify whether there 

were any deficiencies in private sector actions and to determine what changes, if 

any, by the regulators or the regulated could have prevented the outbreaks from occurring. 

We will be hearing some alarming stories today about food safety practices. We 

should keep some perspective on this. According to the Centers for Disease Control 

and Prevention (CDC) there are approximately 76 million food-borne illnesses a 

year, which result in an estimated 5,000 deaths and 325,000 hospitalizations. These 

numbers indicate that food safety regulations, standards, and guidelines should be 

reviewed and updated frequently and enforced to ensure that all Americans are eating wholesome and safe food. 

While any death or hospitalization is one too many, it is not so clear whether we 

are experiencing a significant across-the-board spike in food-borne illness outbreaks 

compared with a decade ago. Data last April from CDC surveillance showed that 

illnesses from consuming raw seafood (mostly oysters) have spiked well above the 

late 1990s, but that the relative rate of salmonella and virulent E. coli outbreaks— 

although rising in recent years—were still below the 1996–1998 baseline. 

We should nevertheless be constantly vigilant for ways to improve our food-safety 

regulatory system. The goal is to reduce the risk of food borne illness, while maintaining the wonderful variety, abundance, and value of our nation’s food supply. 

Imports are a special regulatory challenge, but technology advances are providing 

tools that can help address the risks domestically. Due to advances in information 

technologies, including PulseNet and FoodNet, the CDC and the state health departments now have access to and can input surveillance data into national databases that monitor and track food borne illnesses. These technologies, instituted in 

the late 1990s, serve as powerful investigative tools to help uncover the sources of 

food borne illness outbreaks in our country. 

Prior to these systems, tracking food borne illnesses and tracing the illnesses back 

to root sources was more cumbersome and incomplete. Now that we are doing a better job of tracking food borne illnesses, we should work to make sure this information is put to maximum use to improve safety systems. 

This hearing focuses mainly on several companies that have produced food products that have been contaminated by harmful pathogens including E-coli, salVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
10 

monella, and botulism. These contaminants can lead to human illness especially in 

children and the elderly. 

Our witnesses today are divided into two panels, but are here for one reason: we 

all want to discern what both the public and private sector can do to reduce the 

risk of food borne illness. I understand that the American public wants someone to 

be held accountable: corporate or otherwise. 

However, before we can determine what should be done, we need to answer some 

fundamental questions: What is the source of contamination in each one of these 

cases? Can it ever be identified? Can we identify deficiencies in the company practices that would have prevented and would prevent this harm in the future? Would 

increased federal regulations address these deficiencies or is it merely a matter of 

closely adhering to existing rules and practices? Are some of the cases representative of bad actors that violated existing regulations and need penalties enforced 

against them? 

I have a hunch, Mr. Chairman, that we will find today a range of answers, depending on the case before us. For that reason, I think one of the difficult but useful 

goals for us this morning is to sort out clearly for the record the separate lessons 

we can draw from each of these cases. 

I look forward to the witnesses this morning, and their variety of perspectives and 

expertise. This promises to be an informative hearing. 

### 

Mr.STUPAK. Thank you, Mr. Shimkus. 

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. Good morning to the Chairman. Thank you for 

holding this hearing. 

I commend you for the vigor of your oversight of food and drug 

and other important matters of concern to this Committee. Oversight of food safety is one of the most important undertakings of 

this Committee, and it appears that this is a subject that needs the 

most vigorous attention of the Committee. 

Today we are going to hear from leading companies in the food 

processing industry about what does or does not work in safeguarding our food supply. Unfortunately we are forced to return to 

issues and to hear from witnesses from our prior hearing of last 

April. At that time ConAgra testified regarding the discovery of salmonella in their Peter Pan peanut butter. What we did not know 

then, due to FDA obfuscation and delay, was that this problem was 

more serious than we had been told. After the hearing we learned 

that many more jars containing the deadly bacteria had been 

found, and that some had been processed fully six months after 

ConAgra claimed that the problem had been fixed. Since last 

April’s hearings we have learned of another problem with ConAgra. 

Apparently their Banquet brand of pot pies have made hundreds 

of Americans sick. While the source of this contamination is still 

in doubt, ConAgra blames Butterball, who claims that the turkeys 

for the pies was the source of the problem. Butterball disagrees and 

claims that their turkey is fully cooked before it is shipped. Ironically, the FDA has no opinion on the matter. Today we hope that 

these companies can clarify this issue and assure the consumer 

that their products are safe. We also hope that we will hear something from the FDA, which will enable us to have some confidence 

that they know what they are doing. 

11 

Last April we also heard testimony about contaminated lettuce 

and spinach. We were assured then that the problem was under 

control due to the issuance of new voluntary compliance standards. 

Since then, however, we have had two more recalls of leafy greens. 

We will hear from Dole Foods as well as from Mr. Brackett of the 

Grocery Manufacturers Association who recently retired as the 

head of food safety at FDA, and helped develop these voluntary 

standards. Suffice to say that we have questions about some of 

these proposals. And we also want to hear how voluntary standards 

can be made to work to protect the consumers. Apparently there 

is some evidence to the contrary here before us this morning. 

We also will hear from two firms where botulism has been found 

in their low acid canned foods. This is very unusual. It is the first 

time in more than 30 years that such products have been infected 

with botulism in this country. One of these plants even had a 

USDA inspector on the premises for full-time. We also wanted to 

hear from the head of the California Meat Packing Company who 

recently recalled 143 million pounds of beef, including 55 million 

pounds destined for our school children. It appears that the head 

of this company has refused our offer to testify voluntarily. We will 

now have to consider whether we need to compel his appearance 

to probe how on-site USDA inspectors could have missed these 

safety problems and the inhumane treatment of animals who were 

slaughtered there. 

Finally, Mr. Chairman, I would like to address the broader issue 

of industry responsibility. Under this Administration we have experimented with voluntary health and safety regulations to protect 

our food. Yet it appears that our food supply becomes more dangerous all the time both from imported products and from domestically produced products, sometimes contaminated by unwise imports from China and other places. It is clear that our regulatory 

system is broken. It is plain that Food and Drug does not have the 

personnel. It does not have the money. It does not have the resources to carry out its important responsibilities. It is also appearing to me that they do not have the leadership that is necessary 

to do the things that are required for the protection of the American consumer. 

I am going to urge industry to provide serious recommendations 

today, and more importantly, to strongly support legislation that 

will ensure food safety. The time has passed for halfway measures 

or asking regulators to do more with less. I began listening to the 

rather plaintive remarks of the head of Food and Drug when Mr. 

Young was the head of that agency. And he used to call me up and 

tell me, Dingell, we are going to do a good job. We have a new system, which will make it possible for us to do the job better with 

less money. It turned out it was hooey, and he is no longer with 

the agency. This is a situation, then, which is serious. The health 

of the American people is at stake. I urge our witnesses and others 

in the industry to join with us in changing the current system. I 

can assure you that this will not be the last time that you will be 

before us testifying about another recall and another failure in protecting our Nation’s food supply. I look forward to an explanation 

of what you have done, why this has happened and what you are 

12 

going to do to assure us that this will not occur again. Thank you, 

Mr. Chairman. 

[The prepared statement of Hon. John Dingell follows:] 

STATEMENT OF HON. JOHN D. DINGELL

Mr. Chairman, thank you for holding this hearing. Oversight of food safety is one 

of the most important undertakings of this Committee. 

Today we will hear from leading companies in the food processing industry about 

what does or does not work in safeguarding our food supply. Unfortunately, we are 

forced to return to issues and hear from witnesses from our prior hearing last April. 

At that time, ConAgra testified regarding the discovery of Salmonella in their 

Peter Pan peanut butter. What we did not know then, due to FDA obfuscation and 

delay, was that this problem was more serious than what we had been told. After 

the hearing, we learned that many more jars contained the deadly bacteria and 

some had been processed fully 6 months after ConAgra claimed they had fixed the 

problem. 

Since last April’s hearing, we have learned of another problem with ConAgra. Apparently, their Banquet brand pot pies have made hundreds of Americans sick, 

while the source of the contamination is still in doubt. ConAgra blames Butterball, 

which supplies the turkey for the pies. Butterball disagrees and claims their turkey 

is fully cooked before shipped. Ironically, the FDA has no opinion on the matter. 

Today, we hope those companies can clarify this issue and assure the consumer that 

their products are safe. 

Last April, we also heard testimony about contaminated lettuce and spinach. We 

were assured then that the problem was under control due to the issuance of new 

voluntary compliance standards. Since then, however, we have had two more recalls 

of leafy greens. 

We will hear from Dole Foods as well as from Mr. Brackett of the Grocery Manufacturers Association who recently retired as head of food safety at FDA and helped 

develop those voluntary standards. Suffice it to say, we have some questions about 

those proposals. 

We also will hear from two firms where botulism has been found in their low acid 

canned foods. This is very unusual. It is the first time in more than 30 years that 

such products have been infected with botulism in this country. One of those plants 

even had a USDA inspector on premises full time. 

We also wanted to hear from the head of the California meat packing company 

who recently recalled 143 million pounds of beef, including 55 million pounds destined for our school children. It appears he has refused our offer to testify voluntarily. We now will have to consider whether we need to compel his appearance to 

probe how on-site USDA inspectors could have missed these safety problems and the 

inhumane treatment of the animals that were slaughtered there. 

Finally, Mr. Chairman, I would also like to address the broader issue of industry 

responsibility. Under this Administration, we have experimented with voluntary 

health and safety regulations to protect our food. Yet, our food supply becomes more 

dangerous all the time. 

It is clear our regulatory system is broken. I urge industry to provide serious recommendations and, more importantly, strongly support legislation that will ensure 

food safety. The time has passed for half measures or asking regulators to do more 

with less. Our health is at stake. If you don’t join us in changing the current system, I can assure you that this will not be the last time you join us in testifying 

about another recall and another failure in protecting our Nation’s food supply. 

Mr.STUPAK. Thank you, Mr. Dingell. 

Mr. Barton, for an opening statement, please. 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr.BARTON. Thank you, Mr. Chairman, for holding this hearing 

on the contaminated food and private sector accountability. 

I want to say at the outset, and while there are partisan differences in the Congress on various issues, on this issue, the issue 

of food safety for the American people, there is no daylight between 

13 

Mr. Stupak, Mr. Dingell, Mr. Shimkus, myself and the Republicans 

and Democrats on this oversight, subcommittee and the full Committee. 

If you go back not too many years ago most families, mine included, grew most of what they consumed. My grandparents and 

great-grandparents both grew up and lived on farms in central 

Texas. They grew their own—they raised their own cattle, chickens, pigs. Both of my great-grandmothers and grandmothers had 

huge truck gardens. I can remember in the early 50s if I wanted, 

when it was in season, if I wanted green beans or corn I went out 

and picked them and brought them in. And my grandmother 

shucked the corn and boiled it and split the green beans and we 

had—that is what we had. I doubt they are many families in America today that do that. We depend on a vast network of producers 

and distributors and processors so that when, like my 21⁄2-year-old 

several days ago wanted a banana, I did not go out in the backyard 

since banana trees would not grow in Texas anyway. I went to the 

grocery store and bought some bananas. I think I paid 20 cents a 

pound for them or something. 

It is absolutely imperative that the food safety, the food products 

on the shelves of our grocery stores, is beyond question. Now, I 

don’t believe anybody in this room would say that you do not support that. Yet, when we look at the record, it is stunning how much 

impaired food is reaching our shelves and the dinner tables of 

American families. If statistics are to be believed in the last year 

5,000 Americans died because they consumed contaminated food 

products. Most of those products were beef or seafood. A large number of the products apparently were imported from overseas, and 

a fair amount of that from the—from China. 

I am working on a bipartisan basis to introduce legislation in the 

very near future that would give the Food and Drug Administration the authority to have jurisdiction outside the United States 

when necessary to protect our food supply and do food inspections. 

We have got a letter of support from the Administration. The Clinton Administration supported this type of legislation. There have 

been some court decisions that said it was ambiguous, so I am 

hopeful that between myself and Mr. Dingell, Mr. Stupak and Mr. 

Shimkus and others, we can introduce that bill very soon. But in 

the meantime we will continue to do, you know, aggressive investigative oversight. I want to commend Mr. Stupak and Mr. Dingell 

and Mr. Shimkus for their role in this effort, and I look forward 

to this hearing. 

We have the National Governors downstairs in the big committee 

room on the SCHIP program, so several of us are going to be shuttling back and forth between food safety and SCHIP. They are both 

important hearings and they both deserve the committee’s attention. I thank you, Mr. Chairman, for holding this hearing. 

[The prepared statement of Hon. Joe Barton follows:] 

STATEMENT OF HON. JOE BARTON

Thank you, Chairman Stupak. Let me note at the outset that I support the Committee’s continued oversight of food safety and its efforts to gather new information 

on this issue. Nobody should have to worry whether dinner will make them sick, 

and my feeling is that most people will resent it if we let politics get between us 

14 

and good policy. So I look forward to working with you and writing bipartisan legislation to ensure that eating isn’t going to become dangerous. 

The various food-borne illness outbreaks, recalls, and import alerts over the past 

year raise questions on how to improve food safety even in the changing the realities of the modern marketplace. As we do so, we should not forget that it isn’t the 

government, but the marketplace, that puts dinner on the table. Cutting-edge technologies and global connections have brought tremendous gains in variety and costsavings to the American consumer. Like ancient Athens, our country draws the 

produce of the world into our markets, so that to the American, the fruits of other 

countries are as familiar a luxury as those of his own. We must preserve these benefits as we detect and eradicate any deficiencies in safety. 

The cases we are looking at today raise legitimate concerns about failings in food 

safety oversight. Some of the health hazards are known, but surely not all, and 

many of the exact causes are not established. 

Where we believe the facts and science support a safety problem, we should ask 

what changes, including legislative changes, could have prevented harm or at least 

reduced its probability. For example, if a company’s microbiological testing misses 

traces of dangerous pathogens, but FDA’s tests on the same products detects them, 

it seems plain that something at the company needs to change. But should the 

change include mandating particular testing methods for all companies? I don’t 

know the answer yet, and I am not sure if one case study can answer that question. 

The truth remains that in some of the cases we are examining today, the source 

of contamination simply isn’t known yet, at least not by us. I hope that we get more 

answers from these companies today. And, I hope that these companies will explain 

what they plan to do to reduce the likelihood of future contamination in their products. 

Our job is to find the right balance between federal regulation and industry responsibility. As overseers of safety, we want to protect the American public’s health, 

but without strangling industry’s productivity, creativity, and ability to supply 

Americans with the products they want to buy. I hope we begin to understand today 

where that balance lies and that our witnesses can offer their ideas on how to increase food safety. 

No one here is going to tolerate lying, cheating, or wantonly violating any federal 

statute or good manufacturing practice, much less one that delivers food to be consumed on dinner tables or school lunchrooms. If laws or regulations were violated, 

the violators should be held accountable, and I can assure everybody here today that 

both Democrats and Republicans are of one mind about this. If laws or regulations 

are not being adequately enforced, those agencies should also be held accountable 

by us, and on a bipartisan basis. 

Thank you, Mr. Chairman, and I look forward to listening to our witnesses’ testimony. 

Mr.STUPAK. Thank you, Mr. Barton. 

And it is good to remind the members we will be moving back 

and forth. This week alone I think we have seven hearings for this 

committee, so it is going to be a busy week. 

Mr. Doyle, for an opening statement, please. 

Mr.DOYLE. Mr. Chairman, I am not going to make an opening 

statement, but I do just want to reiterate what our distinguished 

Chairman and ranking member both said. 

We count on you folks to make sure this food supply is safe. In 

the Pittsburgh City School District we were recipients of some of 

this meat that had to be thrown away. It is a scary thought, that 

any parent or child, when we go and buy things in our stores 

should have to worry about whether or not this meat is going make 

us sick or kill us. Something obviously has to be done, and the industry needs to take this very, very seriously because I can assure 

you we take it very seriously. 

Thank you, Mr. Chairman. 

Mr.STUPAK. Thank you, Mr. Doyle. Mr. Burgess, for an opening 

statement, please. 

15 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr.BURGESS. Thank you, Mr. Chairman. 

And to the interest of time I will keep my remarks brief. I think 

we have 10 witnesses that will testify before us today, and it is an 

important topic, and I am anxious to get to the matter at hand. 

This committee has aggressively pursued the issue of safety of the 

Nation’s food supply. And I think we have made some progress in 

identifying some of the areas of the law where perhaps we have 

some inadequacies. Since our committee has jurisdiction over the 

Food and Drug Administration we have jurisdiction over roughly 

80 percent of the food supply. In my opinion, especially for food imports, we should try to get the Food and Drug Administration 

standards, especially the equivalency standard up to a par with the 

United States Department of Agriculture, which has jurisdiction 

over the other 20 percent, specifically meat and poultry. 

We have had a lot of hearings on this, and I think through those 

hearings, at least my opinion, that is where the danger primarily 

is. And I have actually introduced legislation that will address 

some of the safety problems with imported foods, specifically H.R. 

3967. And we have rules in this country, but clearly the rules are 

not always followed, and they are not always enforced, but we have 

strict rules to keep our food safe. Other countries don’t have the 

same rules, and I do not believe that we should accept food from 

other countries that do not certify that they abide by our standards. 

While today we are discussing a specific incident at a specific 

plant history has proven that our meat is safe in this country because of the rules the United States Department of Agriculture has 

and the regulations that they have in place. Unfortunately, those 

rules this time were not enforced in California, but the rules were 

still there. 

Mr. Chairman, as you know I am from Texas, and we like our 

beef. However, we also realize the dangers to consumers if beef 

products are not handled correctly. Our Nation has long recognized 

that our meat and poultry industry needed specific inspections and 

specific rules and regulations. Those inspections and rules and regulations must be enforced. There is simply no margin for error. 

There are no justifications to not enforce the rules. I am grateful 

the Humane Society brought this issue before us today, but I do 

have to wonder why they waited so long. The video was taped during the fall in the month of October, and they knew that the meat 

was going to school children. So why wait until February to release 

the video? Now, the Humane Society has friends on the hill. I count 

myself as one of those. I worked with the Humane Society on the 

issue of horse slaughter back in my home state of Texas, and working to affect the horse slaughter ban. So they have friends on the 

hill. Why wait until now to bring this to our attention? Their delay 

in no way absolves the companies involved or the United States 

Department of Agriculture for their part in this. But I certainly 

would like the Humane Society to address this issue. 

Mr. Chairman, we must be thorough. We must be methodical as 

we continue to approach the issue of food safety. I look forward to 

continuing this important conversation today and working with the 

16 

leadership of this committee, and drafting legislation regarding the 

safety of the food supply, specifically the 80 percent that is under 

the jurisdiction of the Food and Drug Administration and as a consequence under the control of this committee. 

I thank you for holding the hearing, and I will yield back the balance of my time. 

Mr.STUPAK. Thank you, Mr. Burgess. 

As to the video that you mentioned, we will have it right after 

the opening statements here. The video was given to law enforcement first. It took law enforcement some time to react. That is why 

the Humane Society did not put it out publicly. It was given to law 

enforcement so they could do their law enforcement work. I agree. 

Yes. And I don’t think anything would have been done unless there 

had been the threat to release it publicly, because I think law enforcement may have fallen short here on this notification. We will 

have another hearing. I guarantee you. The Humane Society is 

here though. 

Let us see. Opening statement, next to go to Mr. Murphy, please. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr.MURPHY. Thank you, Mr. Chairman. 

And one of the things I realize in my time in Congress is how— 

what a mess it is, the Federal Food Safety Program. I believe there 

is over two, perhaps three, dozen laws and areas that make up the 

Federal Food Safety Program and no single agency oversees them 

all. This continues to be a nonsense gone fragmented system. And 

I believe we saw the situation where the Department of Agriculture 

and specs, open-faced meat sandwiches and frozen pepperoni pizzas, and the FDA inspects closed-faced sandwiches and cheese pizzas. We have had intensive hearings on that. One of the most challenging scientific things of our time. I say that tongue-in-cheek because sometimes it is ridiculous of how this system here in Washington works. And one of the things that I hope comes out of these 

hearings today is hearing from the witnesses of the how we can 

help make it better. That is critically important. Yes, we do have 

problems, and they are significant with 5,000 deaths and 325,000 

hospitalizations a year of people who have food poisoning. I might 

add that also disturbing to me is we have two million hospitalizations a year and 90,000 deaths a year from people who pick up an 

illness in a hospital. Something that is certainly far more severe 

in terms of the number of fatalities we have, and also should demand the attention of this and other committees and the Engineering Commerce committee. But, nonetheless, in Pennsylvania where 

agriculture is our number one industry, where we have high quality companies in Pittsburgh, such as Heinz and Del Monte, we 

know the challenges are ongoing in preventing outbreaks in food 

borne illnesses. It has to be something that we all have to work at 

together. And I know there is a great deal of motivation for us all 

to point the fingers of blame. I want those fingers to point towards 

solutions, and not just be a time of roderick for us to be coming 

up with a tax. Every single statement made should be pointed in 

some direction of how we can make this system work better. The 

17 

public demands it. The public deserves it, and this committee needs 

to work on it. And I yield back. 

Mr.STUPAK. Ms. DeGette, for an opening statement, please. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms.DEGETTE. Thank you, Mr. Chairman. 

I am sure our witnesses have heard that we are all running from 

hearing to hearing. I think there are seven subcommittee hearings. 

And the Health Committee subcommittee hearing is also an issue 

I have been working on a lot. The SCHIP bill, so between food safety and SCHIP I want apologize to the witnesses for running back 

and forth today. 

Over the last year this subcommittee has had five hearings examining the safety of our Nation’s food supply. I am glad we are 

continuing this investigation, which has brought to light some serious inadequacies in our system, both in the public and private sectors. But sadly the hearings have turned out more questions than 

answers, and even more sadly, like just last week, there have been 

more outbreaks every time we have a hearing. What is absolutely 

maddening is that these incidents are preventable. In almost every 

case we can trace the serious threats to public health back to an 

agency that has been starved for funding or to a corporation with 

substantial agricultural or industrial practices. 

I want to welcome the CEOs who are here with us today, and 

I am looking forward to hearing your testimony. I want to focus 

just a minute on ConAgra, because that is a major food producer 

nationwide, which has operations in my state of Colorado. Six 

years ago it was ConAgra which appeared before us to talk about 

one of the biggest recalls in history, after E. coli was found in its 

beef and so many people got sick. Last year they were before this 

committee talking about the peanut butter that was tainted with 

salmonella. Then it revealed that its popcorn contained chemicals 

that could make workers and consumers sick. And then this past 

fall citizens around the country were poisoned by ConAgra made 

pot pies containing salmonella. You can see how frustrating this is 

for us as representatives of the consumers, because the companies 

come before us, apologize profusely, and then they tell us about the 

new facilities they are installing or the money they are spending 

to make sure nothing like this happens again. So for example 

today, ConAgra is going to talk about its fantastic progress in ensuring the safety of Peter Pan peanut butter. Well, that is great 

news, but what about the pot pies? What about the next thing? I 

am sure the company has taken great pains at great expense to ensure the safety of the product, but what the next outbreak? And 

that is what we are worried about. With an organization this large 

that touches so many segments of the marketplace what can we do 

better to ensure these outbreaks do not happen in the future, rather than just coming in and apologizing but for the past? Now many 

of the companies before us today have been involved in massive recalls of tainted products. The members of this committee know that 

I have been introducing legislation for many years, H.R. 3484, that 

would grant the USDA and FDA mandatory recall authority. My 

18 

constituents are frankly shocked when they learn that right now 

these agencies do not have mandatory recall authority. They think 

they do, because they hear about the recalls. And they don’t realize 

that the recalls are as a result of voluntary recalls by these companies. All of the recalls today, when they finally occurred, were 

issued voluntarily. And it is my contention that waiting on the 

company to make the decision is truly the fox guarding the hen 

house. ConAgra, for example, did not order a recall immediately 

upon learning of illnesses related to the pot pies. They issued a 

consumer advisory instead. It was only after days had passed, and 

even more people got sick, that the company decided it was in its 

financial best interest, in addition to the public interest, to recall 

the products. So this legislation, H.R. 3484, would correct the conflict of interest by allowing the USDA or FDA to order recalls as 

soon as it became clear that an outbreak has occurred, and it provides for the immediate notification of consumers and public health 

officials. 

I want to thank you, Mr. Chairman, for continuing to work on 

these issues and I will pledge to be your partner, as always, as we 

move along. I yield back. 

Mr.STUPAK. Thank you, Ms. DeGette. 

Ms. Blackburn, for opening statement, please. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Ms.BLACKBURN. Thank you, Mr. Chairman, and I thank you for 

the hearing today and to all of our witnesses as everyone is saying. 

We do have the SCHIP hearing that is going on downstairs, and 

we are back and forth. But we appreciate the hearing and the attention that is being put on this issue, because it is a high priority 

issue. It is not only one of public health and an issue that we are 

addressing on the public health front, but also the National security front. 

I had a really interesting episode occur recently or a little occurrence. I was in my hometown in the grocery store strolling my 

buggy down the aisle, and someone was passing me and they said 

how do you know what to buy? How do you know what is safe anymore? And they kind of chuckled and rolled on. They had been 

watching the hearings. They were aware of what we were doing, 

but to me it points out something very, very important. There is 

a certain level of trust that the American public has of the products 

that you all produce. And they want to know with a certain degree 

of assurance that when they go to that grocery store and they take 

something off the shelf and put it into that buggy that it is safe. 

When they pull it out of the freezer compartment that it is safe. 

And when they cook it and serve it to their family, after having followed the directions, that everybody is going to be OK. 

And my hope is that we can get through this. This is our fifth 

hearing as you have heard. It is something that we are tremendously concerned about, and we want to be certain that not only 

the FDA, but you all go from defense to offense. And how do we 

best accomplish that? I have been just amazed that only one percent of the 8.9 million shipments of imported food are inspected. 

19 

One percent. And we know from the USDA that we are expected 

to import a record 70 billion in agriculture products this year, 

which is double the nearly 36 billion purchased in ’97, and that we 

have seen total food imports. The total imports have increased by 

50 percent in the last five years, and it is frustrating to us that 

the FDA does not have a timeline for how they are going to change 

their practices to address this issue. So that something we are focused on and we are going to continue to work on. 

I am not going to go through my full statement. You all have 

been very patient with us. We are going to be up and down. But 

I will tell you when we hear about recalls of pet foods and toothpaste and pizza products and baby formula, this is something that 

does get our attention. And we are going to seek accountability, 

greater accountability, through reform of the FDA system. We are 

looking for ways that we can make certain that the food coming 

into our product streams is something that is reliable and safe. 

They trust, the American consumers, trusts that we will do that. 

I am looking forward to making certain that everyone agrees to 

work together to make certain we reach this goal. Mr. Chairman, 

I thank you for the time, and I yield back. 

Mr.STUPAK. Thank you. That concludes the opening statements 

of members of the subcommittee. 

I’d like to call our first panel of witnesses to come forward. 

[Witnesses sworn.] 

Mr.STUPAK. Before we hear the witness’s testimony I would like 

to show a brief video that was produced by the Humane Society as 

part of their undercover investigation of the Hallmark/Westland 

Corporation’s slaughter house operation. 

We invited Mr. Steve Mendell, the CEO of Hallmark/Westland to 

appear to day, but he refused the Committee’s invitation. I do, 

however, plan to discuss this matter with the Chairman and with 

ranking members Barton and Shimkus as to our next step in compelling Mr. Mendell to appear before this committee to explain his 

company’s behavior. Before we run the video I must caution viewers some parts of it is quite graphic. Kyle, run the video. You may 

want to dim those lights. I don’t know if anyone can see it with 

these lights on. Then after the video we will start with opening 

statements. 

[Video shown.] 

Mr.STUPAK. That concludes the video. We will start with our 5- 

minute opening statement for our witnesses. You may submit a 

longer statement if you wish, for inclusion in the hearing record. 

Mr. Greger, we will start with you, please. Dr. Greger. 

STATEMENT OF MICHAEL GREGER, M.D., DIRECTOR OF PUBLIC HEALTH AND ANIMAL AGRICULTURE, THE HUMANE SOCIETY OF THE UNITED STATES 

Dr.GREGER. Mr. Chairman, members of the subcommittee, thank 

you for this opportunity to testify about the—— 

Mr.STUPAK. Try pulling your mic up a little bit. Even up here it 

sounds like we are having a little bit—had a little bit of trouble 

here getting to project our voices. Go ahead. 

Dr.GREGER. Thank you for allowing me to testify about the horrendous animal cruelty and food safety issues that we uncovered 

20 

in our extensive hidden camera investigation of this dairy cow 

slaughter plant in California. 

My name is Michael Greger. I am a medical doctor and serve as 

director of Public Health and Animal Agriculture at The Humane 

Society of the United States. That video you saw was narrated 

from the perspective of our undercover investigator, who worked at 

the Hallmark packing plant for 6 weeks at the end of 2007 in both 

October and November. And personally witnessed and documented 

the egregious mistreatment of animals, particularly these downed 

cows to sick or injured to even stand or walk. And I trust you can 

appreciate the identity of this investigator must be kept confidential for his own safety and to not compromise the efficacy of his 

current investigative efforts and future efforts. It is critical to first 

point out that the agency did not cherry pick this plant. This plant 

was selected at random, and only during the course of the investigation did we learn that Westland was the number two beef supplier for the National School Lunch Program, that Westland was 

a USDA supplier of the year, and that this facility had been previously cited for mishandling animals, with allegations going back 

over a decade. 

The blatant cruelties highlighted in the video are not isolated 

cases. They were daily happenings at this plant every day the 

worker was there. The horrific treatment of animals we documented is being downplayed as an aberration. Unconscionable, yet 

the work of just a handful of rogue employees. We don’t think this 

is an accurate characterization. It has since come to light that this 

plant, Hallmark/Westland, has a long and well documented history 

of abusing downed cows. In fact, FSIS cited Westland in 2005 for 

mishandling animals and the local Pomona Valley Humane Society 

and SPCA had notified USDA multiple times about possible violations dating back to 1996. And this is not the only plant that has 

been documented to have downer cows going into the food supply. 

The USDA’s own Office of the Inspector General chastised the 

agency in 2006 for violating its own downer policy. The OIG sampled 12 slaughter plants over a 10 month period, and found 29 

downed cows going into the food supply. Again, violating the 

USDA’s own interim final rule passed in 2004 after the first case 

of BSE was discovered in the United States. 

Downed cattle are not only more likely to be infected with BSE, 

bovine spongiform encephalopathy or mad cow disease, but studies 

suggest they may also be more likely to harbor food borne pathogens, such as E. coli 0157H7, and salmonella. No surprise, perhaps, 

given the fact that many of these animals may be wallowing in 

their own waste. Despite the potential health risks, despite the legitimate animal welfare concerns, and despite their own Inspector 

General finding violations, the USDA in 2006, instead of strengthening the final downer ban rule they critically weakened it. Codifying a loophole into it that allowed some downed animals to continue to be slaughtered for human food. Currently inspection personnel are allowed to determine on a case-by-case basis the disposition of cattle that go down after passing antemortem inspection. 

And this loophole provides the incentive, the financial incentive, for 

what you just witnessed on that video. Workers trying every cruel 

tactic imaginable to get—to force downers up for the inspection, 

21 

knowing full well that should the animal then collapse down for 

good the loophole allows the inspector to pass downed animals. To 

pass that downed animal as USDA approved beef. If, on the other 

hand, downers could not go into the human food supply then there 

is no reason to prolong her misery. Even if a cow is down even for 

just what appears to an acute injury, like she breaks her leg, there 

may be an underlying disease that caused her to fall and break it. 

Indeed, at least three of the documented BSE cases in North America, were injured cattle. These infected cattle were identified as 

downed not due to illness, but due to injury. One, indeed, just 

broke a leg. Another slipped on ice. All right. And so the meat is 

safe, right? Because it is ‘‘just an injury,’’ but it turned out it was 

more than just an injury. They had mad cow disease. A truly comprehensive ban on the use of any meat from downed animals in the 

human food supply is needed to protect food safety and animal welfare, and with vigorous enforcement, of course, to ensure compliance. USDA must rewrite its rules to close the current loophole and 

redirect resources to provide adequate oversight. 

Finally, we urge Congress to enact swiftly two pieces of legislation that will help prevent such abuses from reoccurring. H.R. 661, 

the Downed Animal and Food Safety Protection Act by Representatives Ackerman and LaTourette, would implement a comprehensive 

ban on processing downed animals, which the USDA has so far 

failed to do. And H.R. 1726, the Farm Animal Stewardship Purchasing Act, by Representatives DeFazio and Shays should set 

basic animal welfare standards for producers who sell to the National School Lunch Program and other federal programs, including 

no downed animals. 

Thank you, again, for this opportunity to testify about this important animal welfare and food safety issue. 

[The prepared statement of Dr. Greger follows:] 

22 


49369.007
23 


49369.008
24 


49369.009
25 


49369.010
26 


49369.011
27 


49369.012
28 


49369.013
29 


49369.014
30 


49369.015
31 


49369.016
32 


49369.017
33 


49369.018
34 


49369.019
35 


49369.020
36 


49369.021
37 


49369.022
38 


49369.023
39 


49369.024
40 


49369.025
41 


49369.026
42 


49369.027
43 


49369.028
44 


49369.029
45 


49369.030
46 


49369.031
47 


49369.032
48 


49369.033
49 


49369.034
50 


49369.035
51 


49369.036
52 


49369.037
53 


49369.038
54 


49369.039
55 


49369.040
56 


49369.041
57 


49369.042
58 


49369.043
59 


49369.044
60 


49369.045
61 

Mr.STUPAK. Thank you. 

Mr. Williams, opening statement, please. 

STATEMENT OF JOHN A. WILLIAMS, EXECUTOR DIRECTOR, 

SOUTHERN SHRIMP ALLIANCE 

Mr.WILLIAMS. Good morning. My name is John A. Williams, and 

I am here today both as someone with 30 years of experience in 

the shrimp industry and as Executive Director of the Southern 

Shrimp Alliance. 

I operate a small business in Tarpon Springs, Florida, and I am 

proud to have the privilege of representing the other small business men and women in the shrimp industry. Thousands of other 

small businesses of men and women in the shrimp industry 

throughout the Gulf of Mexico and the south Atlantic. 

Mr.STUPAK. Would you pull that mic up a little bit closer, please, 

sir? 

Mr.WILLIAMS. Thanks. I appreciate the opportunity to testify on 

the FDA’s failure to protect Americans from harmful seafood imports. I ask the committee to refer to my written comments for 

more detail on the urgent need for meaningful FDA reform. 

There can be no denying that the FDA is broken. The essence of 

FDA’s approach to imported food safety is to accept unverified representations of importers who have repeatedly disregarded the 

safety of American consumers. We know and the FDA knows that 

aquaculture in much of the developing world has led to the introduction of harmful contaminants into our imported seafood. Imported foreign raised shrimp are often produced with minimal quality control in crowded ponds filled with feces, banned antibiotics 

and toxic chemicals. And yet, the FDA’s only check on self-serving 

representations is the inspection of one percent of seafood imports. 

The FDA’s failure to prevent importation of massive amounts of 

contaminated shrimp has a number of negative effects on our market. In addition to putting consumers at risk, contaminated shrimp 

imports depress demand for all shrimp when consumers fail to distinguish between safe and unsafe sources of shrimp. Shrimp buyers 

know that shrimp sources from farms in countries with lax controls 

are likely to be contaminated and, therefore, offer lower prices. 

In addition, the simple fact that large amounts of shrimp enter 

the U.S. market that should not have been allowed to enter further 

depresses prices for all shrimp. The combination of stringent imported food safety regimes and other major importing markets and 

lax enforcement of U.S. law encourages the diversion of contaminated seafood to the United States. Canada, Japan and the European Union all do significantly more to protect consumers than the 

FDA to safeguard the American public. As a result our Nation has 

become a dumping ground for rejected and inferior seafood products that could not be exported to other countries. 

For example, when the EU imposed a complete ban of shrimp 

from China in 2002 because of illegal antibiotic use, Chinese 

shrimp imports to the United States shot up 30 percent in one 

year, adding millions of additional pounds of shrimp to this market. And the same thing happened when the EU decertified Pakistani seafood products in April of 2007. In just 2 months, Pakistani 

shrimp to the U.S. jumped from 0 to 165,000 pounds. Now we are 

62 

facing the same problem with Vietnam. While the EU, Japan and 

Canada all have recently taken action against Vietnamese shrimp 

for illegal antibiotic use the FDA has done nothing. The FDA has 

sufficient evidence of the hazards of farm raised seafood from Vietnam, both from its own investigation and as we have been told by 

reliable sources from direct admission by Vietnamese authorities, 

of the widespread use of banned substances in the production of 

farm raised seafood. And for some of those substances the FDA apparently has no testing protocol to detect them. Concerns about the 

FDA’s inability to assure the safety of the imported seafood has 

risen to the point that states have been doing their own testing of 

seafood imports. And these states have repeatedly found harmful 

banned substances in the imported seafood they test—seafood allowed by the FDA to enter this country. While we are pleased that 

state governments have attempted to step into the breech, the burden of ensuring that imported seafood is safe to consume should 

not be forced upon them. There is no substitute for a strong federal 

food safety system. Unfortunately, the FDA appears to take action 

only when facing a crisis or public outrage. 

We respectfully suggest that this committee should be outraged. 

We have prepared a series of proposals for legislative changes to 

improve the safety of imported seafood. These proposals are discussed in detail in my written testimony, but I will provide a couple of examples here. 

The FDA should require, as a condition of importation, that the 

country of origin of an imported seafood product administer a system of food safety that is equivalent to that of the United States. 

Also, the FDA should take note of the detection by other major importing countries of contaminants in food so that the FDA can 

focus its enforcement effort. For the health of our consumers, for 

the integrity of our Nation’s food supply I ask you, members of this 

committee, to enact meaningful FDA reform. The FDA has promised before that it can change on its own, but the evidence demonstrates just how dangerous the FDA’s broken promises have become. Thank you. 

[The prepared statement of Mr. Williams follows:] 

63 


49369.046
64 


49369.047
65 


49369.048
66 


49369.049
67 


49369.050
68 


49369.051
69 


49369.052
70 


49369.053
71 


49369.054
72 


49369.055
73 


49369.056
74 

Mr.STUPAK. Thank you, Mr. Williams. 

Mr. Marler, opening statement, please, sir. 

STATEMENT OF WILLIAM D. MARLER, ESQUIRE, MARLER 

CLARK LLP PS 

Mr.MARLER. Thank you. 

Chairman and members of the committee, my name is Bill 

Marler. I am a trial lawyer. My law firm Marler Clark located in 

Seattle, Washington specialized in representing victims of food 

borne illness. Unfortunately for my clients and many of the corporations that are going to come after me, I have been in business 

too long. I thank you for the honor of being allowed to testify before 

this committee. I am proud of the work this committee has done 

to try to improve food safety throughout the United States. 

Although I have never had the honor to testify before Congress, 

I have had the honor to be here before in 1994 for Senate hearings 

about the lack of safety in our food supply. At that time I was with 

Brianne Kiner, then 9 years old, who spent 6 months hospitalized, 

suffered acute kidney failure and multiple strokes, had her large 

intestine removed, was in a coma for over a month, and spent 100 

days on dialysis, all from eating a hamburger. Thirteen years later 

I was here again in April of this year. This time with Ashley and 

Isabella Armstrong, who I think the committee would all agree 

were the cutest kids you have ever seen before any committee. Victims of the more recent spinach outbreak that sickened 205, killing 

five. I was with Sean Pruden, the victim of the E. coli outbreak at 

Taco Bell, that sickened over 100, and with Terry Marshall, whose 

mother-in-law has remained in a nursing home to this day after 

eating a few spoonfuls of salmonella tainted peanut butter. Since 

1993 I have had the privilege to represent thousands of Americans, 

some your constituents. In 2002, during the middle of yet another 

E. coli outbreak, during the middle of another visit to an ICU to 

watch a new client struggle for life, attached to more tubes than 

you can imagine, I penned—for the Denver Post. Here’s part of it. 

This summer scores of Americans, most of them small children 

and senior citizens, have already or will become deathly ill after 

eating ground beef boldly labeled USDA approved. The now infamous outbreak started with a few sick kids in Colorado and quickly 

spread coast to coast, eventually triggering the recall of 19 million 

pounds of ground beef tainted with E. coli 0157H7. Because their 

parents trusted our government’s food inspections several kids suffered kidney failure and dialysis, or weeks hooked up to all sorts 

of machines. For some the long-term prognosis is grim with the 

risk of further kidney failure, dialysis, transplants or worse. Most 

of these kids’ parents’ have hired me to help them get compensation for hundreds of thousands of dollars in medical costs, and the 

risk of future kidney failure. That may prompt some readers to 

consider me a blood sucking ambulance chaser who exploits other 

people’s personal tragedies. If that is the case, here is my plea. Put 

me out of business. For this trial lawyer, E. coli has been a far too 

successful practice and a heartbreaking one. I am tired of visiting 

with horribly sick kids who did not have to be sick in the first 

place. I am outraged with the food industry that allows E. coli and 

other poisons to reach consumers and a President, Congress and 

75 

federal regulatory system that does nothing about it. Stop making 

kids sick and I will happily move on. That, ladies and gentlemen, 

was in 2002. The time has finally come to put me out of business. 

The CDC estimates that there are still 76 million Americans getting sick every year, each and every year, from eating food. That 

means one in four Americans will contract a food borne illness 

every year. Hundreds of thousands will be hospitalized and thousands will die. That is the human suffering part. There is also a 

business part. Billions of dollars will be spent on medical treatment 

and many more billions will be in lost wages, in recall costs, in the 

sale of food and yes, in legal fees to defend and prosecute these 

companies. Civil litigation in America is a blunt instrument for 

change. It is better for the government and business to work together to eliminate the need for lawsuits and lawyers. When American business poisons its customers and when our regulatory agencies do not have the manpower, willingness, or ability to help businesses perform, people die and market share is lost nationally and 

internationally. It is time to help business and consumers to simply 

make me unnecessary. If you fix the food safety system trial lawyers like me will become a small irrelevant footnote in history, but 

you will be remembered and honored for helping to fix a broken 

system. 

The issue of food safety is not new, of course. A century ago 

Upton Sinclair’s book The Jungle exposed both contamination of 

meat processing and corruption that led inspectors to look the 

other way. What has changed since Upton Sinclair’s time? Are we 

better off than we were 100 years ago? A year ago I was asked by 

the spinach and lettuce growers of California to address them in 

Salinas. Considering that by then the leafy green industry was on 

its knees financially and I had lawsuits pending in several states, 

it was a bit of a tense lunch. Why was I invited? I am frankly still 

not sure, but why I was suing them was all too clear. In the prior 

10 years there had been 21 outbreaks related to fresh leafy products with hundreds sickened. In 2006 hundreds became sick and 

five died from eating E. coli contaminated spinach, followed quickly 

by lettuce outbreaks at Taco Bell and Taco John. The common denominator, California lettuce and spinach and more lawsuits. Mexico banned the importation of California spinach and lettuce. I told 

the quiet audience of growers and producers a story that I believe 

at the time to be true. I told them I had seen, since the 1993 JackIn-The-Box case, I told them what seemed to have happened after 

the Jack-In-The-Box crisis was the incidence of E. coli seemed to 

decline. In fact, the CDC indicated by the year 2006 that E. coli 

cases tied to ground beef had gone down by 42 percent. I told them 

that they should immulate what the beef industry did. That the 

beef industry had worked hard to put me out of business. And the 

reason I can say that is because during that 2003 to early 2007 I 

had no ambulances to chase because I simply had no E. coli victims 

tied to E. coli—not tied to hamburger. And in the spring of 2007 

started with an ominous uptick in E. coli recalls and illnesses, and 

ended with hundreds sickened, 33 million pounds of meat recalled. 

And guess what? More sick and dead children. And guess what? 

More lawsuits. China banned the import of U.S. beef. And if you 

76 

ask the USDA and industry to explain this uptick, they have none. 

It is unacceptable. 

Although things are certainly different from Upton Sinclair’s 

time there are some big similarities, and certainly some things that 

are new and different challenges. First, there is a terrorist threat 

to our food system. Just as too many could not imagine the horror 

in 9/11, too many cannot envision the kind of food disaster today. 

When a terrorist attacks our food system it will look eerily similar 

to any other outbreaks of food borne illness. Second is the growth 

of imports. Sinclair could not have imagined a world where the 

meat that may be in one hamburger could originate in Argentina, 

Canada and Colorado, or that we would have vegetables year round 

from South America, Asia and Africa. It is with these two enormous issues in mind I offer five suggestions of how to finally put 

me out of business. 

First, create a local, state and national public health system that 

catches outbreaks before they balloon into personal and business 

catastrophe. CDC pulsejet and food net, as one of the members 

mentioned, were launched after the Jack-In-The-Box outbreak and 

are rightly credited for helping reduce the size of outbreaks by 

helping more quickly conclude the suspect product was causing 

harm. But surveillance of human bacterial and viral disease is 

lacking. For many food borne illnesses, for every culture-positive 

case 20 to 50 other cases are missed because of lack of surveillance. 

Most people who become ill with a bacterial viral disease are either 

seldom seen or never cultured. The more people are tested, the 

greater the likelihood that a source, accidental or not, will be found 

sooner. 

Second, actually inspect and sample food before it is consumed. 

At present local and state authorities, along with the USDA and 

FDA, employ thousands of inspectors across the nation and world 

to inspect tens of thousands of plants that produce billions of 

pounds of food. The GEO has warned that our food sampling and 

inspection system is so scattered and infrequent there is little 

chance of detecting microscopic E. coli, or other pathogens for that 

matter. 

Third, consider mandatory recall authority on all food products. 

Recalls must be completed transparent. If a recall is ordered consumers need to know what in fact is being recalled. Full disclosure 

must be the rule. Under the present system of voluntary recalls, 

last September we saw the disastrous Tops recall, where the company knowingly left E. coli contaminated product on store shelves 

weeks after being confronted with an ill customer, and his product 

both testing positive for E. coli. 

Fourth, merge and then adequately fund the three federal agencies responsible for food safety. Right now USDA and FDA share 

this mission with the CDC. The system is, in a sense, trifurcated, 

which leads to turf wars and split responsibilities. We need one 

independent agency that deals with food borne pathogens. You 

have a moral responsibility to consumers in your home town or 

anywhere U.S. goods are sold. It is time to adequately fund our 

health and safety authorities to help businesses protect the consumers. 

77 

Finally, we cannot completely regulate ourselves out of this. 

Standards need to be set with the entire food chain at the table, 

from farmer to manufacturer to retailer and customer. Standards 

must also be based upon good science. We must invest in solid research at our land grant institutions to help producers manufacture food that is safe, nutritious, and the envy of the world. 

Thank you very much. 

[The prepared statement of Mr. Marler follows:] 

78 


49369.057
79 


49369.058
80 


49369.059
81 


49369.060
82 

Mr.STUPAK. Thank you. 

We will begin with questions. Members will have 5 minutes for 

questions. 

Dr. Greger, if I may start with you. In your investigation at the 

Westland/Hallmark, did you investigator ever observe the company 

alerting USDA inspections or inspectors of the cattle that went 

down after the 6:30, and I think you said, 12:30 inspection? 

Dr.GREGER. Never. The investigator did not witness it or hear 

anyone talking about getting the inspector back to look at these 

animals that had subsequently gone down after antemortem inspection. 

Mr.STUPAK. And I take it from the video the person who did the 

video here was fairly close to what was going on in order to make 

those—that video. 

Dr.GREGER. The investigator is what was called a pen worker, 

essentially doing exactly that. Unloading these animals, getting 

them through the pens, and finally into the kill chute. 

Mr.STUPAK. OK. Let me ask this, because it came up in the opening statements. If your investigator was at the plant in, I believe 

you said the Fall of 2007, why didn’t the Humane Society notify 

USDA, the School Lunch Program, about what was happening at 

the plant before the end of January? 

Dr.GREGER. This investigation took over 2 months to complete. It 

was shot—he worked at the plant in October, November. We gave 

this evidence over to the local district attorney’s office the San 

Bernardino County district attorney, and they asked us not to publicly release this information. To hold off so they could carry out 

their own criminal investigation into the animal cruelty that was 

witnessed. We complied with that request, but by January, after a 

month had occurred, we felt we had to go ahead, and so we indeed 

contacted USDA and then made it public. But the fact that downers were being slaughtered for human consumption, this is something that is allowed under the 2007 USDA loophole, and something that the USDA’s own inspector general found was happening 

across the country. 

Mr.STUPAK. I was going to ask you to explain that a little bit 

more, the rule of antemortem inspections of downer cattle. As long 

as the—when the inspector looks at it and/or sees the animal, and 

if the animal is standing it can be used for slaughter. If the inspector leaves, it falls over, it can still be used for slaughter? 

Dr.GREGER. Let me—— 

Mr.STUPAK. Or human consumption? 

Dr.GREGER. Let me kind of explain the chronology of this loophole. In 2000 USDA declared that they would not be using beef 

from downed animals. Evidently agreeing that this meat was too 

risky to be fed to kids at school, but evidently not too risky to feed 

the kids once they get home from school, or to adults for that matter. We have for years been pushing for a complete downer ban, 

but it took a case of mad cow disease in the United States, December 23, 2003, before finally, then Secretary Veneman, within a 

week, said we will have no downer animals, downer cattle being allowed into the American food supply, no exceptions. And a week 

after that they published their interim final rule in the federal register, January 12, 2004, again no downers, no exceptions. And then 

83 

even after, in 2006, when the Inspector General published their critique saying that downed animals were, indeed, going to the food 

supply. In July 2007 when this rule was finalized, instead of 

strengthening the rule, realizing that there wasn’t proper enforcement, they critically weakened the rule codifying in a loophole, 

which allowed for animals that went down after antemortem inspection to on a case by case basis with the inspector’s approval be 

allowed into the American food supply. So, you know, live cows can 

be fed to people, dead cows can only go to pet food or animal feed: 

pigs, pets and poultry. But you get more per pound if the animal 

can, indeed, enter the National School Lunch Program, then can be 

just going to canned pet food. And so if downed animals were indeed lumped in as they should be with dead animals and only fed 

to pets, for example, then if a downed animal arrives on a truck, 

just like when a dead animal arrives on a truck they would be 

thrown—they would be euthanized and thrown on the dead pile. 

There’s no incentive for the workers to kind of prolong their misery. But if some downed animals may—if there is a loophole that 

is saying some downed animals may indeed be passed for inspection into the food supply, then you see the financial incentive for 

the workers to, basically by any means necessary, force these animals up to walk back and forth in front of the inspector. And that 

knowing full well if the animal goes down after inspection then the 

inspector can pass that downed animal into the food supply. Even 

if the animal is down and completely non-ambulatory, and even if 

it appears that this cow was just down because they broke a leg, 

an animal shouldn’t just break a leg at slaughter plant. Either this 

animal is mishandled or maybe the animal was sick, you know, 

confused, unsteady gait, and that is why they fell down. That is 

why Linda Detwiler, the head of the BSE Surveillance, the previous head of the USDA BSE Surveillance Program, has explicitly 

written to the USDA saying that injury and illness are interrelated. If a cow is down, if a cow cannot walk to the kill box it 

should not be slaughtered for human consumption. OK. 

Mr.STUPAK. My time is up and I still had questions for Mr. Williams and Mr. Marler, but we are going to move right on. We will 

go for a second round, and I am going to try to keep members to 

five minutes, because I know you are bouncing back and forth between the different hearings. 

Mr. Shimkus, for questions. 

Mr.SHIMKUS. Thank you, Mr. Chairman. This is, again, a very 

important day and very frustrating, very sad. So some interesting 

points have been raised and what we want to follow up on is—Mr. 

Marler, first of all, I appreciate that work you have done, and your 

testimony is pretty interesting because—and I have dealt with the 

trial bar quite a bit. And, you know, I have a lot of friends. I am 

from southwestern Illinois, Madison County, St. Clair County. 

Friends, but not always allies in the debate. I mean they always 

remind me of, you know, what the vast majority are trying to do 

is, you know, is take up the cause for those who can’t fight for 

themselves. And I think your record has been one of doing that. 

But you also, in your testimony, you also make some interesting 

statements about how instead of the punitive adversarial relationship, that if we really want to get to a place where, I think, we all 

84 

want to be regardless of what side of the dais we sit on. That is 

a credible food safety environment where when, you know, it is 

easier for our female members to talk about going to the grocery 

store, talk about feeding their children. Men are less compassionate, you know, neanderthal sometimes. 

Ms.DEGETTE. Excuse me. But you don’t go to the grocery store? 

Mr.SHIMKUS. I do. I’m a Jif guy though, OK, and a Banquet Pot 

Pie guy, so I am limited in my purchases. The—but talk about this 

relationship about government regulation and corporate responsibility and how in working together. One of your comments talks 

about how—the two things I want to focus upon is that, and also 

the scientific research dollars that you identify is kind of outside 

this whole purview. Because it talks about the formation of pathogens, how they migrate and how, you know, that is something that 

we may or may not be doing that good of a job then. Can you address those two? 

Mr.MARLER. You know, in 15 years of taking the depositions of, 

you know, many corporate leaders and workers very few of them 

have I ever come away with a sense that they did it on purpose. 

Mistakes happen, failure in their system happen. These bugs are 

different. You know, in 1982 0157H7 didn’t even exist as a known 

pathogen. Many of the rules and regulations that USDA goes by, 

you know, go back into the ’50s and ’40s and ’30s. They haven’t 

caught up to somehow some of these pathogens change. I think 

putting more money in research dollars in our land grant institutions to figure out—and you’ll hear this from the corporations that 

follow me. Some of the outbreaks, they don’t even know how they 

happen. And, you know, to be honest with you I don’t even know 

how they happened. And a lot of times in the litigation we explore 

the edges or sort of the dirty edges of that. But the reality is that 

U.S. corporations, it is bad for business to poison consumers. And 

to the extent where, I think, government can be most helpful is not 

to try to look for punitive action against corporations, but is really 

to be sort of a—to work with them both in the research area. And 

then to set aside good science based regulations that help these corporations do the thing that they really want to do, which is ultimately the right thing. 

And I, you know, granted if you did those things you wouldn’t 

have a kind of trial bar, because we would have to go with something else. 

Mr.SHIMKUS. Thank you. And Dr. Greger, I want to follow up 

with my remaining time and appreciate what you have done. That 

is very frustrating. From southern Illinois, a rural area, beef, pork 

producing area, corn, soy beans, livestock of all sorts, it is, I mean 

it is the same business types. And you look at the time, effort and 

energy that is going on with these individuals who try to move 

these downer cows, and you think about real time processing you 

think they are losing time. I mean the time and effort to move 

these instead of just segregating them, getting them through the 

process. 

So I want to follow up on just one of the reports that you cite, 

which is the audit report from January 2006. Dr. Greger, you claim 

that the slaughter of downed cattle is a widespread problem. That 

29 were put to slaughter, however, in this report that you rely for 

85 

this information, and it indicates that only 2 of the 12 plants inspected allowed downer cattle to be slaughtered. To me that would, 

you know—here is a little chart right here. We want to go after bad 

actors. I mean we really want to make sure that people who are 

abusing the system, the available laws, the rules and regulations 

for whatever reasons, that they are held accountable to the fullest 

extent of the law. Especially in the report—the film, you keep highlighting California law, you know, this is going on. The law is being 

broken. And this report highlights two processors, but then it also 

highlights the other 12—10 that are in compliance. So I guess our 

question will be focus in on the bad actors and making sure that 

those who we think are good actors remain good. But is it a systematic world problem of this country, or is it a problem of a few 

bad actors that we need to be concerned about? 

Dr.GREGER. It is a problem with these dairy cow slaughter 

plants. And that is what the IG report found, and that is what we 

found at this plant. This was essentially, what we found out later, 

a magnet plant for what are called ‘‘spent’’ dairy cows. Dairy cows 

under current production only last about 4 years before being kind 

of ground to hamburger. So this plant brought downer cows from 

states surrounding California to this plant. In fact, between 90 and 

95 percent of the cows at this plant were dairy cattle, not beef cattle. And it is these—and USDA estimates, perhaps, 295,000 

downed cattle every year. It is probably more, maybe half a million 

is the latest estimate. But these are predominately dairy cattle at 

the end of production who are spent, who may have metabolic problems, who may have mastitis, infections of the utters, who may be 

lame for other reasons who are transported long distances to get 

to these plants. If we had a complete downer ban, if these cows— 

if it wasn’t worth transporting these animals, then presumably 

they would be euthanized on the farm. And even better there 

would be an incentive for producers to prevent these animals going 

down in the first place by providing adequate bedding. Up to 90 

percent—for example, according to Dr. Grandin, a livestock consultant, up to 90 percent of downers are preventable. And so if you 

can’t get money from a downer cow then there won’t be this incentive to continue to send them and process them. 

Mr.SHIMKUS. OK. Thank you, Mr. Chairman. 

Mr.STUPAK. Mr. Doyle, for questions, please. 

Mr.DOYLE. Thank you, Mr. Chairman. I just have a couple questions. 

I am really intrigued by this financial incentive. It makes a lot 

of sense to me to ban downer cows. I am trying to understand. 

When you saw that video and these workers spending all that time 

and effort to get these cows to stand up—I don’t know much about 

the slaughter business. What is that—I mean is there a financial 

incentive to those workers? Are they somehow paid on how many— 

to go through that extra effort to shock and forklift and roll and 

do all that stuff we saw on the film. And where does that financial 

incentive sit? At the supervisor’s level? I mean do these workers 

have some financial interest in getting those cows to stand up? 

Dr.GREGER. Well, finally the criminal testimony has been published from the San Bernardino district attorney’s office. The Chino 

police did the investigation, and we actually have the kind of writVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00091 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
86 

ten transcript. And these workers claim that this was a company 

policy. That they were under pressure from supervisors to get these 

cows into the slaughter plant. Again, if they are irreparably down 

then they may have to just be thrown on the dead pile, and not 

get those kind of extra pennies per pound that they would be if 

they were allowed into human consumption. And so they claim that 

they were just kind of being pressured from above. But if you see 

more extended—I mean there are hours of videotape. You can see 

some of the online workers coming out, you know, because the line 

is stopped because there is a cow actually downed in the kill shoot. 

And so we have footage where they are shocking animals, actually 

getting cows to trample over downed cows to get into the kill box. 

And so when you have an animal that is actually down in these 

very narrow pens it may actually stop the line completely. And so 

they are coming out saying, what’s the holdup? And so tremendous 

amount of human resources is used. And the only thing I can imagine is, this industry has kind of a razor thin profit margin and that 

losing literally hundreds of pounds of beef, even though some of 

these dairy cattle were quite skinny. I mean potentially losing all 

that weight and you would hear comments from supervisors saying 

this cow is too big to be down, because there is weight there that 

could be sold. 

Mr.DOYLE. Well, what is troubling is the pressure seems to be 

coming from the top. So it is more a culture in that particular corporation at least, which says, you know, we are going to get as 

many cows into that kill box as we can regardless what condition 

they are in. It seems rather troubling that that philosophy is going 

up higher than just at some lower lever. What is the percentage? 

I am just trying to understand to downer cattle to the total that 

go into the kill box. What are we talking about in terms of lost, 

you know, production? 

Dr.GREGER. Because of the kind of unique cattle population that 

was going to this plant, and similar plants like it across the country, our investigator witnessed literally downed cattle every day 

coming off trucks. 

Mr.DOYLE. Ten percent, 20? 

Dr.GREGER. He said that typically on a truck there would be at 

least one downed cattle per truck. 

Mr.DOYLE. And how many cows on a truck? 

Dr.GREGER. And so 30, 35 animals coming down. And so now this 

plant slaughtered 500 cows a day. Had the capacity to hold about 

1,000, so there was this constant, you know, trying to move these 

animals through the system, and as you can see, just extraordinary 

methods used to try to kind of squeeze every last penny out of 

these decrepit animals. 

Mr.DOYLE. Well, it seems to me if you change the financial incentive to keeping cows being able to stand by treating them better. 

You know, if that is the incentive that seems a much better way 

to save money to increase production and certainly is a much more 

humane way to deal with the situation. And maybe that is one of 

the things we should be looking at. How do we create an incentive 

to do it the right way instead of to do it the wrong way? 

Mr. Marler, I just have less than a minute. I just have two questions. You said in your testimony between 2003 and 2006 that E. 

87 

coli outbreaks linked to tainted meat had declined dramatically. 

But since last year there has been this uptick in E. coli illnesses 

and recalls again. Why do you think this is the case and what can 

companies or the government do to reverse the trend? I mean why 

do we get—it looked like we got it right for three years and all of 

the sudden it seems we are headed in the wrong direction? 

Mr.MARLER. I think probably unfortunately, my answer might 

require a full committee hearing on that. And I think there really 

is a need for a committee hearing on that particular issue. I think 

if you reach out to the industry and to USDA they won’t really 

have a great answer, but I think I can give you at least—I have 

reached out to industry. I have reached out to academics, and I 

think there are a couple of things that are going on. One is that 

back in 2006 INS rated a lot of slaughter plants throughout the 

United States, and a lot of really highly qualified, but illegal workers, were forced out of their jobs. And a lot of unqualified, but legal 

workers, got into their jobs. So that was happening in late 2006. 

At the same time with the increased gas prices, oil prices, there is 

more ethanol being used in the system. There is a lot of collocation 

of ethanol plants with feed lots. There are some studies that have 

come out of Kansas State University that show that cattle fed the 

by-product of ethanol production, distillers grain, have a higher 

quantity of E. coli 0157H7 in their guts than normal cows. So I 

think you have a number of things happening simultaneously. You 

have less qualified workers, more E. coli coming into the system, 

and then I think there is an aspect of just, you know, frankly that 

some of these companies I think became complacent. It had gone 

so well for so long. But I can tell you that I have never had more 

severely injured children in my office in 2007 than I have had since 

2002. So something is really wrong. Somebody needs to get to the 

heart of it. I am not a scientist, but those are some of the things 

that I have seen that I think you have to look at. 

Mr.DOYLE. Thank you. Thank you, Mr. Chairman. I see my time 

is up. 

Mr.STUPAK. Thank you, Mr. Doyle. Mr. Walden, questions. 

Mr.WALDEN. Thank you, Mr. Chairman, and thank you for holding this hearing. I think all of us are concerned about our food safety in America, especially as we see the rise of imports coming in, 

and so I appreciate the testimony of all the witnesses. 

I am troubled, though, as a parent of somebody who is in public 

school in Oregon in the northwest. I don’t know if the beef from 

this plant made it into the food chain there, but I assume some of 

it probably did. And I remember when we had the hearings on 

Ketek here, which is a drug, there was a lot of concern about the 

fact that the FDA sort of put criminal investigations ahead of patient safety. And I feel a similarity here that, perhaps, the Humane 

Society didn’t do that, perhaps did, but maybe in coordination with 

San Bernardino. Did you say the sheriff’s office don’t tell—— 

Dr.GREGER. The district attorney’s office. 

Mr.WALDEN. So the district attorney of San Bernardino County 

told you don’t tell USDA there is a food problem here? 

Dr.GREGER. They told us to wait on any kind of public release 

of this information. 

Mr.WALDEN. Is that different than notifying USDA? 

88 

Dr.GREGER. Frankly, the reason we did not go to USDA first is 

because USDA has a history of not responding to—— 

Mr.WALDEN. But I want to get to the point here. So the district 

attorney didn’t tell you not to go to USDA. They just said don’t 

make the video public or—is that right? 

Dr.GREGER. They asked us—— 

Mr.WALDEN. Because I would like to know for the DA, Mr. Chairman, if—well, I guess Mr. Chairman’s magically disappeared. But 

is that what happened? 

Dr.GREGER. They asked us to hold onto the information while 

they completed their investigation and—— 

Mr.WALDEN. Did they notify USDA? 

Dr.GREGER. I am not aware. 

Mr.WALDEN. Well, it just strikes me. Here we have got the largest beef recall in American history. I think that is correct, 143 million pounds. Secretary Schafer felt that it was a big enough issue 

to recall it all, even though most of it now has been consumed. So 

while kids are eating this meat that may or may not be bad, certainly slaughter conditions were unacceptable, and mostly illegal I 

think under USDA rules. Nobody—so you didn’t tell USDA, the district attorney didn’t tell USDA. So even if in the past USDA’s been 

bad about doing recalls on a timely basis, they didn’t even know 

in this case? 

Dr.GREGER. Well, in fact this plant’s behavior had been 

brought—— 

Mr.WALDEN. Right. 

Dr.GREGER [continuing]. To USDA multiple times. 

Mr.WALDEN. A couple of times. I have read that. 

Dr.GREGER. And evidently they—nothing was done. 

Mr.WALDEN. But you had evidence something was wrong on 

tape, right? 

Dr.GREGER. Well, evidence from the Pomona Valley Humane Society—and SPCA, they also had evidence, which they provided to 

the USDA. This was back in 1996, 1997. 

Mr.WALDEN. No. But I mean in this case? 

Dr.GREGER. Yes. 

Mr.WALDEN. You had your Humane Society here or locally had 

the video—— 

Dr.GREGER. Yes. 

Mr.WALDEN [continuing]. Evidence. But that never got to USDA 

until after the district attorney—or in January. You waited a couple of months. 

Dr.GREGER. Until January, and we contacted the USDA before 

releasing it. 

Mr.WALDEN. Let me ask you this. And I wish—I know our jurisdiction doesn’t go out to USDA, so I guess that is why we don’t 

have a witness here. But it seems to me that part of the fault clearly is the faults with the company. I mean at least from—allegedly 

with the companies who are all not getting sued by trial attorneys 

for, you know, whatever. But clearly USDA, it seems to me, didn’t 

do their job in the plant. Are they not supposed to have inspectors 

there throughout this entire process observing? And, Mr. Marler, 

you have got to be an expert on this, and you have done great work 

for injured kids and families, and I applaud you for that. But isn’t 

89 

USDA supposed to have an inspector watching as the cattle are unloaded? 

Mr.MARLER. The short answer is yes, but you have also seen in 

the last—just last week about the lack of inspectors, the numbers 

of inspectors, I think. 

Mr.WALDEN. Right. 

Mr.MARLER. There is a shortage and—— 

Mr.WALDEN. What we get at is, because some of what has occurred and Dr. Greger you may insight it as a good service to the 

public by exposing this problem. But part of what has occurred in 

each of these has already violated existing rules and regulations. 

I think—— 

Dr.GREGER. Right. 

Mr.WALDEN [continuing]. Mr. Marler, you said we can’t regulate 

our way out of this. How do we get it so we can trust our food supply? I mean I am just about—— 

Mr.MARLER. I think the answer is the economic incentive. You 

have got to figure out the economic disincentive to shove these 

cows through the system. And whether that is a complete ban on 

downer cows, a way of, you know, figuring out some sort of tax 

credit to get rid of the cows humanely. There are certain things to 

do. With respect to inspectors one of the things I think that needs 

to be discussed is whether or not more inspectors are necessary. 

Mr.WALDEN. Right. 

Mr.MARLER. Whether or not some of the new technologies that 

are available, both in testing and video cameras and all of that, 

would be available and useful as we all face, you know, difficulties 

with tax dollars. 

Mr.WALDEN. And one other question just for my own sake. Was 

the meat—do you feel that the meat that was recalled posed a 

health risk to those who consumed it? Have you had a chance to 

look at that? 

Mr.MARLER. Let me say that I think that this recall, although 

the video is shocking—— 

Mr.WALDEN. Yes. 

Mr.MARLER [continuing]. There are no ill people. 

Mr.WALDEN. Right. 

Mr.MARLER. And the risk of BSE is so exceedingly low in this instance that I sort of feel that we could use these resources that we 

are spending on this recall and the amount of meat that is being 

recalled. And now it is being expanded into products that might 

have some trace element of this meat. I think we could probably 

spend those resources wisely in other areas. 

Mr.WALDEN. All right. My time has expired. I really appreciate 

your work in these areas. Thank you, Mr. Chairman. 

Mr.STUPAK. Thank you. Ms. DeGette for questions. 

Ms.DEGETTE. Thank you, Mr. Chairman. You know, part of the 

reason we have to do these recalls on such a broad level like this 

one is because we don’t really have traceability with our meat supply. Is that correct, Dr. Greger? 

Dr.GREGER. We—— 

Ms.DEGETTE. I mean we can’t trace back which lots of meat may 

have contained the meat from those downed cows that we saw on 

the video, right? 

90 

Dr.GREGER. My colleague, Mr. Marler, is probably best able to 

answer that question in terms of the traceability and in terms of 

the kind of proprietary—— 

Ms.DEGETTE. Yes. 

Dr.GREGER [continuing]. Of this data. I mean—— 

Ms.DEGETTE. But I am correct, right, Mr. Marler? 

Mr.MARLER. Correct. 

Ms.DEGETTE. And so if you can’t trace which exact lots these 

downed cows were in you have to have these broad recalls. That 

is another piece of legislation I have got, the Trace Act, that I am 

doing with Congresswoman DeLauro. Because we feel like when 

Mr. Shimkus goes to the grocery store because his wife sent him 

and he buys a package of hamburger he can’t tell—and this is part 

of the problem we have with these recalls. He can’t tell if he goes 

to you because his kid gets sick and you, his lawyer, look at the 

package that the meat came from we can’t trace that back to what 

lots that came from. So we don’t know if those lots contained those 

downed cows, correct? 

Mr.MARLER. For the most part that is true. 

Ms.DEGETTE. Now you have done a lot of litigation around food 

safety, and you know that there are some manufacturers actually 

do have traceability, correct? 

Mr.MARLER. Correct. 

Ms.DEGETTE. So we could actually technologically do it with 

meat, right? 

Mr.MARLER. My friends at Dole now have instituted some of the 

most far reaching traceability on their lettuce. 

Ms.DEGETTE. And we have heard from them in some of 

these—— 

Mr.MARLER. Right. 

Ms.DEGETTE [continuing]. Hearings. They do have great 

traceability and that would help. That would both help consumers 

have more confidence, but it would also help industry not have to 

do these massive recalls. And yet unbelievably, Mr. Marler, every 

time I bring industry in to talk with me about traceability they oppose it. You don’t even have to respond to that. You were talking 

earlier about economic incentives, and I completely agree with that, 

which is why I think mandatory recall is also a good idea. Let me 

talk for a minute about the—one of the things you talked about in 

your testimony was the Tops beef recall from last year, and how 

E. coli contaminated products were on the shelves for three weeks. 

Why do you think it took Tops so long to recall that beef? 

Mr.MARLER. Well, it was a combination really of Tops and the 

USDA working or not working in concert. There was an ill child 

in Florida that tested positive in her stool for E. coli 0157H7. Meat 

in her freezer tested positive for E. coli 0157H7. It was a genetic 

match, but the USDA had a rule at the time. They no longer have 

that rule. The rule at the time was that if, if the meat came from 

an opened box of—and this was preformed patties—— 

Ms.DEGETTE. Right. 

Mr.MARLER [continuing]. With plastic covers. If it came from an 

open box they would not institute a recall. 

Ms.DEGETTE. OK. 

91 

Mr.MARLER. But what happened was they waited. They waited 

weeks until more victims piled up, and that is when the recall happened. 

Ms.DEGETTE. Yeah. Well, OK. So in the ConAgra peanut butter 

recall this is what happened. There was a couple of years, I think 

2004, there was a whistle blower complaint about the peanut butter contamination at the ConAgra plant in Georgia. And so the 

FDA investigators went in to check it out, and they asked ConAgra 

to give them some documentation, and ConAgra said no. Because 

not only do we not mandatory recall, we don’t have apparently 

mandatory document production unless they have got you to subpoena them or us—— 

Mr.MARLER. But they have given those documents. 

Ms.DEGETTE. Well, yes, they have. Because you know why? We 

had a congressional hearing then in this subcommittee and low, 

right before the subcommittee hearing ConAgra changed its policy 

and they did give over the document. Well, then what happened 

was they actually had complaints and they had a shutdown in 

2006, I believe, of the plant from the contaminated peanut butter. 

But so all of this time you have the complaint, then you have this 

kind of gray area where people are going back and forth, then finally you actually get people sickened. Then you finally shut—you 

had the CDC shut the plant down. That was several years later. 

My view all along has been that if you had the USDA and the FDA 

with authority to do mandatory recall with hope you wouldn’t have 

to use that very much. That just the threat of a mandatory recall, 

economically, would make the producers act much more quickly on 

a voluntary basis. What is your view on that? 

Mr.MARLER. I think mandatory recall is in a sense what everybody believes happens. Everybody in the—if you go out to some of 

the—— 

Ms.DEGETTE. Just what I said in my opening statement. 

Mr.MARLER. Exactly. Everybody believes it, but it is not really 

the case. In 15 years of representing victims I can tell you unequivocally that there have only been a handful of cases where 

companies did not quickly do the recall when confronted with the 

facts. It is—so most companies, in fact—— 

Ms.DEGETTE. OK. 

Mr.MARLER [continuing]. Ninety-five percent of all companies 

will act responsibly. Whether or not the government wants to take 

on that responsibility of mandatory recall is something, I think, 

frankly the government has to think about pretty hard. 

Ms.DEGETTE. Thanks. 

Mr.STUPAK. Mr. Burgess, for questions. 

Mr.BURGESS. Thank you. Mr. Marler, can we just continue on 

that thought for a second, because this comes up too with the Consumer Product Safety Commission. Another subcommittee where 

this statement or the philosophical approach that the voluntary recall is, perhaps, the more nimble or agile way to go about getting 

an unsafe product off the shelf. Because as you just pointed out the 

companies are themselves anxious if there is what—I got to believe 

if I am faced with the possibility of a mandatory recall, are you 

swearing out of rit, that I will be more frightened of the rit that 

you swear out than I would be of the USDA or the FDA issuing 

92 

a mandatory recall. So if I am a company and I am told that there 

is going to be—the likelihood of voluntary recall I go to take that 

very, very seriously, I think, because of the blunt instrument that 

you wield out there. Is that—in the food safety arena is there any 

parallel with the consumer product area where they say we can be 

more nimble and more quick with a voluntary recall, rather than 

going to mandatory route where now we have got to—someone has 

got to hire counsel. We have got to go in front of an administrative 

law judge to get this thing proved up. Where it is going to take 

weeks to get that done, and where as a voluntary recall can be 

done within days. Is that a fair statement? 

Mr.MARLER. I think there is a place for where government investigators and government regulators and companies can find sort of 

a happy medium on having the stick of mandatory recall, but the 

opportunity for a voluntary recall. And in an essence, that is what 

I think for the most part in the food industry that is what happens. 

There is sort of a—— 

Mr.BURGESS. I think so too. 

Mr.MARLER. And so I think it is one of those sort of things that, 

I think, that there are some issues, especially with respect to bioterrorism. I think those are some things that I think we have to 

have a fallback position. The government can ultimately have that 

responsibility to pull product off the shelf. 

Mr.BURGESS. And I can’t help myself. I have got to ask you this 

question. When you had that lunch with the spinach growers what 

did they serve you? 

Mr.MARLER. We had spinach salad and spinach and chicken. I 

actually—there were about 50 more photographers here in front of 

me watching to see whether or not I ate the spinach. And I have 

to tell you I did and it was delicious. 

Mr.BURGESS. All right. Well, good. Again, I couldn’t help myself. 

I just had to know. Now, on this issue that is before us this morning with the issue of the Humane Society brought to the floor is— 

if this had been E. coli in this meat in October would the justification of waiting until the DA had his ducks in a row, would that 

be something that you would have seen as a positive response to 

a crisis this order of magnitude? 

Mr.MARLER. Well, I think the fact of the matter is that E. coli 

0157 is an—and under the USDA food code. And so any time a 

product has 0157H7, as long as it is hamburger, there are some 

quirks in the law that allow E. coli 0157H7 to be on other meat 

products. And that is another thing the hearing probably should be 

about. But the fact of the matter is that if, in fact, there was a 

0157H7 positive it would have been recalled, and so there wouldn’t 

have been a lag. And so I—— 

Mr.BURGESS. Well, I guess what I am getting at is the issue of 

scaling. I mean an E. coli contaminate, people on dialysis, people 

in the ICU. BSE, nobody gets sick—— 

Mr.MARLER. Right. 

Mr.BURGESS [continuing]. Except for three people and there is an 

issue of scale there. And I guess what concerns me, Dr. Greger, is, 

you know, you didn’t want to go public with it because the DA 

wasn’t ready. But you don’t have to go public to go to the USDA. 

I mean you could do that confidentially, can you not? 

93 

Dr.GREGER. We have had experience with the USDA not following up on animal cruelty charges, even when they have potential public health implications. It wasn’t illegal to process downed 

animals. It is illegal to not tell the inspector about it after antemortem. It is illegal to treat the animals like we saw. These were 

criminal charges, so we went to the state and local authorities, 

which did the criminal investigation. 

Mr.BURGESS. But at the same time there was a public health 

issue where, in your opinion, some of these were downer cows that 

should never have made their way into the stream of commerce for 

school lunches. And, I guess, what is really bothering me is that 

gap of time where all these lunches are served in November, December and January, and the product is consumed. If you are concerned about the public health aspect, even though the incidents of 

BSE is far less than if you truly had an outbreak of something as 

devastating as E. coli, but still if you are concerned about that why 

not do something? I mean it seems like the USDA could handle 

that confidentially where it wouldn’t mess up the DA’s case down 

the road. 

Dr.GREGER. The USDA has procurement policies that disallow 

downed animals into the National School Lunch Program. But 

when we were at this plant we didn’t know—— 

Mr.BURGESS. With all due respect that sounds like a bureaucratic answer. I mean I think what the American public wants to 

know is how can they in the future feel safe knowing that here the 

Humane Society had some data that is pretty darn important. Important enough for you to come to this subcommittee this morning 

and show us an emotional film, and not important enough that we 

don’t stop it going into the stream of commerce. That is what the 

American people don’t understand. I mean I realize there can be 

bureaucratic reasons, but to be quite frank with you I just say 

those are not acceptable. 

I appreciate it, Mr. Chairman. I know I have gone a little bit 

over. I will yield back. 

Mr.STUPAK. Do you want the gentleman to answer? 

Mr.BURGESS. If he has—— 

Mr.STUPAK. Do you want to answer his last—— 

Dr.GREGER. We were not aware that this was a supplier to the 

National School Lunch Program while we were doing the investigation. The USDA does not disallow downer meat, but we know that 

the National School Lunch Program does. So had we known that, 

perhaps, we would have been able to get that information. But 

downed animals continue to this day. It is unfathomable to the 

American public that we continue to allow any downed animals as 

USDA inspected meat. And so we are hoping that this investigation 

will not only shore up food safety across the board, but that we will 

finally have a downer ban. We knew downed animals were going 

to the food supply, but that is legal. It is legal for downed animals 

to go into the food supply thanks to the July 2007 USDA loophole. 

Mr.STUPAK. OK. Thank you. We are going to go another round 

of questions here as members. Mr. Inslee, you have not asked questions yet. I’m sorry. And we will after, Mr. Inslee, we will go the 

second round. 

94 

Mr.INSLEE. Thank you. I want to welcome my constituent neighbor, Bill Marler. And, Bill, I want to thank you for your work. You 

have done as much, perhaps, as Congress in trying to assure food 

safety over the last decades, and I want to thank you for it. And 

that work is just beginning, and we thank you for your efforts. 

We are talking about the difference between voluntary standards 

and regulatory legal enforcement standards. My staff handed me a 

quote from 1906 from Sinclair Lewis and he says, ‘‘it is difficult to 

get a man to understand something when his salary depends on his 

not understanding it.’’ And it seems to me that that 1906 observation might apply. You and I have talked about the need for standards regarding vegetables and leafy products, and we have talked 

about the success we have had in the meat industry. Even though 

we have got a problem here today there were improvements in part 

because of your litigation, and in part because some of the things 

Congress did. Can you talk about what you think we ought to be 

doing as far as leafy vegetables, non-meat products, to try to learn 

from the experiences in meat to improve our food safety? 

Mr.MARLER. I think the first thing that you have to do is, really 

in many respects, really partner with consumer groups and industry, and your governmental agencies, as well as academia. There 

is a lot of research that still needs to be done as to how these 

pathogens get on these products, and why they are able to be 

transported for a long period of time and, you know, exactly how 

they operate. And the thing about these bugs too is that they 

morphin change over time. So whatever regulatory scheme, whatever standards you set, will always be things that will have to be 

in somewhat fluid motion. But I think the most important thing is 

to work with industry, to work with consumers, to build safety nets 

and to create a culture of food safety. There is a real big lack of 

both solid research, a lack of funding at research institutions, there 

is a lack of enforcement simply because you don’t have enough 

FDA inspectors. I mean we talked about the ConAgra plant. That 

inspector was in there in 2005. Most FDA inspectors very seldom, 

maybe once a year, once every other year, will get to major manufacturing facilities. Those are the sorts of things that really need 

to change. But, again, it has to do I think first with good solid 

working relationships with these partners in this room, but also 

good research. 

Mr.INSLEE. You have suggested consolidation of these agencies 

into one single purpose agency. And I assume because in regard to 

USDA you think that there is a conflict between the promotional 

responsibilities of this agency and the regulatory food safety. I am 

assuming that. Maybe you can comment on that. 

Mr.MARLER. As Tommy Thompson said, certainly before he left, 

it is just really a matter of not whether, it is a matter of when we 

have a bioterrorism act against our food supply. A bioterrorism act 

against our food supply will look absolutely exactly like these 

things on your charts, but it will be somebody that did it on purpose. And my view is that that really should be where Congress 

needs to focus its energy and attention. And I think that is why, 

in my experience, especially in cases where FDA, USDA and the 

CDC are all in a sense in the same pot, there are so many conflicts 

between those agencies about information sharing, information 

95 

gathering that sometimes they stumble over each other for trying 

to do the right thing. But they just simply stumble over each other, 

and it slows the process down of being able to figure out what the 

cause of an outbreak is sooner, rather than later. 

Mr.INSLEE. Let me ask you something that may not be a headline grabber, but grabbed my family a few months ago when I had 

a family member get, you know, sort of violently ill suddenly, 

which we thought may have been food related. No long-term lasting damage. I didn’t have to give you a call. Just some days of 

great distress. And I suspect that is going on in thousands of occurrences across the country with no sort of reporting system, because 

there is no real medical intervention. Is this a problem? And number one, what can we do about that sort of lesser severity issues? 

Mr.MERLE. I think that—and that is probably something that 

this committee and Congress is, you know, acutely aware of. That 

our public health system has some real challenges. And the fact is 

that even with our concern about bioterrorism we haven’t put the 

money in on the ground for investigators to do testing of victims 

of potential food borne illnesses. Because, again, that is where you 

are going to catch it. You are going to catch it in the ER’s. You are 

going to catch it in doctors’ offices. And that is where you are going 

to catch these outbreaks before they balloon into something that is 

worse. So I think looking at how our public health system operates 

or doesn’t operate, and giving physicians the tools, specifically with 

respect to stool cultures for vital and bacterial illnesses, would get 

us a long way there to stopping some of these outbreaks before 

they get bigger. 

Mr.INSLEE. We hope the wisdom from Bainbridge Island becomes 

the national policy. Thanks, Bill, for being here. 

Mr.MARLER. Thanks. 

Mr.STUPAK. Going to a second round of questions here. 

Mr. Marley, let me ask you this. It is my understanding, you 

know, we talked about the other recalls. Jack-In-The-Box, we got 

Tops, and now we got this Westland/Hallmark hamburger area. 

When you do hamburger, when they go through these slaughter 

houses, they trim from different animals that are going down and 

load up the burger, and it is put in a box, and the box can weigh 

up to 2,000 pounds. And the way we inspect it, you reach in, you 

take a little bit out, you inspect it. If it passes that whole 2,000 

pounds go, correct? 

Mr.MARLER. Yes. 

Mr.STUPAK. So how do you then really do an inspection of the 

quality of the meat or the hamburger that is being produced? And 

as you said earlier it is the dairy cows that sort of is the basis for 

our hamburger in this country, right? 

Mr.MARLER. Seventeen percent of—— 

Mr.STUPAK. Seventeen percent. 

Mr.MARLER [continuing]. Hamburger in the country is from—— 

Mr.STUPAK. OK. 

Mr.MARLER [continuing]. Dairy cows. 

Mr.STUPAK. So how do you really get at it if—how do you get at 

these microorganisms, E. coli, whatever may be there? 

Mr.MARLER. When the inspecting system was created in the 

United States most of the people didn’t understand how bacterial 

96 

or viral illnesses sickened people anyway. You were looking for 

things. You were looking to see if the cow had tumors or if it was 

tubercular. You were looking for those sorts of things. It is a new 

day now, and these pathogens are out there. Some of them, you 

know, morph. We have seen new forms of E. coli. Pathogenic E. coli 

show up in our food system just in the last few years. We have the 

technology to do scientifically based testing. In fact, one would 

argue that many of the retail outlets, the Jack-In-The-Boxes, 

McDonald’s, the big retails outlets forced random testing onto suppliers. Which was what I think one of the reasons why E. coli 

0157H7 cases went down so dramatically after 2002, because we 

were testing. It is not a perfect system, but random scientifically 

based 0157H7 testing can get us a long way to making our food 

supply safer. 

Mr.INSLEE. But after Jack-In-The-Box we came up with the 

HACCP Program for hazardous detection. But then, as you said 

here, here is the meat recall that is just in the last 12 months 

there have been 91 recalls, 63 of them are meat alone. 

Mr.MARLER. Right. 

Mr.INSLEE. So has government then said well, we have this 

HACCP system, therefore, industry is self regulating itself. We 

won’t have to do it. 

Mr.MARLER. I think that is why that is the problem. You have 

got to not only—it is not only a partnership with industry to help 

set the standards so they are actually workable standards that 

make sense, but I do think that there has to be ultimately your 

people on the ground in the plants making sure that the kinds of 

abuses that we saw at Westland/Hallmark don’t occur. The sort of 

follow-up that didn’t occur by FDA officials at the ConAgra plant— 

to make sure that those, in fact, do occur. It is a resource issue. 

It is a manpower issue. 

Mr.INSLEE. Any reason why we should not label meat products 

that is treated with carbon monoxide or seafood with carbon monoxide to let the consumer know? 

Mr.MARLER. No, I see no reason why. 

Mr.INSLEE. Mr. Williams, let me ask you this. In your testimony 

you are talking about shrimp and you are talking about when Pakistan went from 0 to 165,000 pounds. China dumping it here. 

Mr.WILLIAMS. Yes. 

Mr.INSLEE. What is the danger here? You are saying the FDA 

isn’t inspecting it. Explain this, especially when we are talking a 

little bit about pathogens and all that in shrimp and other—and 

you said Vietnam’s next on our list we got to watch for? 

Mr.WILLIAMS. Right. Well, when another importing nation, such 

as European, Japan or the European Union, Canada, increases 

their inspection rates when they find problems, which they do. 

They inspect up to 25 percent. We inspect less than one percent. 

When they increase their inspection rate the imports suddenly stop 

going to those countries and they—— 

Mr.INSLEE. So in other countries increase their inspections the 

imports stop, and they get shifted to the United States. So we become the dumping ground. 

Mr.WILLIAMS. Exactly, exactly. 

97 

Mr.INSLEE. We have had other hearings where it indicates, let us 

say, like seafood especially, they will bypass our inspections in San 

Francisco where we have a very good lab and go, let us say, to Las 

Vegas and bring it in the back door. Is that a continuing problem? 

Mr.WILLIAMS. That is the term they use. They call it port shopping. They will send this product to a port that will be the less likely to inspect their product, and if they do inspect it they don’t— 

they have the option of taking it back out of the country or it will 

be destroyed. Of course they will take it back out of the country 

and send it to another port with what may not get inspected. You 

ought to have a 99 percent chance of getting it in without being 

inspected. 

Mr.INSLEE. What are the fungi and antibiotics that may be found 

in shrimp and other seafood? We had one report that summed the 

seafood being treated with carbon monoxide. About 20 percent of 

it was already rotted before it was ever sent to the United States, 

but the carbon monoxide, of course, masked the problems with the 

seafood. 

Mr.WILLIAMS. Right. 

Mr.INSLEE. So what are the fungi and antibiotics we look for? 

Mr.WILLIAMS. In seafood there is malachite green. There is a 

host of nitrofurans, chloramphenicol, which is—causes several irreversible blood diseases such as aplastic anemia. And what is particularly troubling with some of these diseases is you will not see 

this for probably 10 years down the road. We don’t know what 

amount causes these diseases. That is why we have a zero tolerance on it, and it is banned worldwide for use in food consumption. 

Mr.INSLEE. OK. Thank you. Dr. Greger, my time is up at this— 

what did your undercover—if you know, what did your undercover 

investigator tell you USDA inspectors were doing? You said 6:30 

and 12:30 was their inspections. What were they doing in between? 

Dr.GREGER. There are on-line and off-line inspectors. So by law 

a plant cannot operate without on-line inspectors looking at the 

carcasses. However, the plant can continue to work if there aren’t 

these off-line inspectors. They are the ones that are looking at the 

pens and supposedly doing random checks. Not in this case. Not 

looking at the unloading of animals. Not looking at them antemortem, before the slaughter of these animals. And so the plant 

can continue to operate. So in a situation of understaffing the inspectors are in the plant on the line and others, you know, may get 

out or maybe between multiple plants. I mean in some areas of the 

country there are more severe understaffing issues than others. 

Mr.STUPAK. OK. Thank you. Mr. Shimkus, questions. 

Mr.SHIMKUS. Thank you. Let me just follow up Dr. Greger one 

more time on the whole terminology of downer. These are dairy— 

spent dairy cattle? 

Dr.GREGER. Yes. 

Mr.SHIMKUS. Spent dairy. And they are shipped from multi-state 

regions, so they arrive—downer means they are down, right? That 

is kind of the definition. They could be down for a lot of different 

reasons? 

Dr.GREGER. Correct. 

Mr.SHIMKUS. We—obviously mad cow. People—we know that. 

But downer doesn’t mean that all these are mad cow. They could 

98 

be just fatigue and major fatigue. They could have been going without food and water for multi-hours over the road haul. So, and you 

mentioned one per tractor trailer load. What should have this processor done? Should they have—and think if he was processed. Just 

segregate the downed cattle? Could they have allowed that downed 

cattle then time to recover if it was just fatigue and water to then, 

without assistance, get up on its own and then process through the 

veterinarian check and then—or by definition once down, always 

down regardless of the reason it was down? 

Dr.GREGER. Well, what should have happened—I mean downer 

animals are veterinary emergencies and should be treated as such, 

and they should receive individual veterinary treatment or they 

should be humanely euthanized. But there is a system in which 

one can segregate so-called ‘‘suspect’’ animals, and see if indeed 

they can perk up and are able to walk on their own. And then by 

definition they are no longer downer cattle. At this plant there was 

no suspect pen. There were no suspect stickers. 

Mr.SHIMKUS. If they would have just moved all these downed 

cattle to a pen, a suspect pen, and then monitored those and those 

that were able to revive processed back through, and those who 

can’t then deal with them as per law. 

Dr.GREGER. The problem is, is it is very difficult to humanely 

transport these downed animals. Hundreds of pounds and so how 

are you going to do it? As you can see—— 

Mr.SHIMKUS. Right. 

Dr.GREGER [continuing]. Forklifts and chains. I mean there are 

humane ways to do it via these sleds and—but it is something that 

is, you know, much more intensive and—— 

Mr.SHIMKUS. Right. 

Dr.GREGER [continuing]. It may just make more sense to 

euthanize them on the spot certainly. 

Mr.SHIMKUS. Thank you. The—and, Mr. Williams, thank you for 

your patience. I am glad the Chairman directed some questions. On 

this whole imported shrimp, who makes the wholesale purchases of 

this imported shrimp? 

Mr.WILLIAMS. I am sorry? 

Mr.SHIMKUS. Who makes the wholesale purchases of the imported shrimp? 

Mr.WILLIAMS. That would be mostly the importers and distributors. 

Mr.SHIMKUS. And what obligations do the firms who are purchasing through the wholesalers have in testing the shrimp? 

Mr.WILLIAMS. I am sorry. Say that again. 

Mr.SHIMKUS. Well, here is my frustration in the food processing 

perspective. It is not a cost benefit to business, especially with the 

ability of litigation, food recalls, you know, to—I actually have a 

hard time believing that companies willfully, for a profit margin, 

allow unsafe foods to the market. I believe, I think, that there are 

mistakes and errors. There is evolution to these pathogens. We 

need to do more science to figure out how to stop this stuff. In the 

manufacturing process if you are building a car and you are going 

to a—you got a wholesaler who is creating the widget and has to 

be one millimeter of inch, it is tested before it is exported to the 

assembly line. And when the person receives it they are testing to 

99 

make sure it is within the specifications. So isn’t there testing on 

both? Shouldn’t there be testing on both ends? 

Mr.WILLIAMS. There is testing on both ends. We are under strict 

Federal, State and local guidelines, or health guidelines, to test our 

product whether they are imported or not. But once they reach 

these shores and the FDA allows them in because of their lack of 

testing we don’t test for chemicals. Our shrimp are not tested for 

illegal antibiotics or chemical contamination. We are tested on the 

safety and the quality of it going out to the consumer. 

Mr.SHIMKUS. Should we? 

Mr.WILLIAMS. I don’t know. They shouldn’t be allowed in because 

there are no chemicals in domestic shrimp. 

Mr.SHIMKUS. Right. 

Mr.WILLIAMS. Those shrimp should be tested before they leave 

the foreign nations. 

Mr.SHIMKUS. Right. 

Mr.WILLIAMS. And here also before they come into our market. 

Mr.SHIMKUS. And I think there is credible debate on the—we 

definitely don’t want to be the dumping ground when other countries have established some standards, you know. Not always when 

you set standards—hopefully they are scientifically based. That 

makes sense. And then we don’t want to be the overflow and the 

dumping ground for that. But I also think it is just not good business if you know that there are additives in foods that affect the 

people that you are trying to sell your product to. To not test—establish those standards and not purchase it if it doesn’t meet those 

standards. 

Mr.WILLIAMS. Well, I agree. And therein lies the problem that, 

you know, these shrimp should be tested. We should have at least 

equivalence with the foreign countries as we do here. Have it at 

least the same amount of testing over there as they do here. In 

2006, for example, the FDA tested 2,480 inspections of domestic 

fish and fishery products here in the United States. Only 200 in 

the foreign nations, and we imported over a billion pounds of 

shrimp that year. And we produced 200 million. 

Mr.SHIMKUS. And so your basic premise is our domestic standards are much higher than our imported standards. 

Mr.WILLIAMS. Well, yeah. We think the—yeah, the health standards are. Yes, but like I said we don’t test for chemicals. 

Mr.SHIMKUS. Right, OK. Thank you, Mr. Chairman. 

Mr.STUPAK. Mr. Walden, questions. 

Mr.WALDEN. Thank you, Mr. Chairman. I want to make a point 

that getting back to this issue of the malachite green, which was 

the carcinogen in eels. Which, I guess, South Korea banned in July 

of ’05, and then Canada in January of ’06. And it took our FDA 

another 8 months after, or 7 to figure it out. But what do we need 

to do here? 

Mr.WILLIAMS. Well, I think we have put together what we think 

is a very comprehensive food safety program that the FDA should 

adopt and put in place. And, you know, I have heard that we can’t 

inspect our way out of this mess. That may be true, but we can certainly do a better job than what we are doing. But I think if they 

look at our—in our written comments if you will look at our safety 

100 

program that we think is very comprehensive and would take us 

out of this mess. 

Mr.WALDEN. OK. I guess as a consumer, you know, and I have 

supported country of origin labeling and all, and then been shocked 

as I go down the seafood display at my local grocery store just 

where stuff comes from. I wanted assurance that what I am buying 

for my family is safe. 

Mr.WILLIAMS. Yeah. 

Mr.WALDEN. And I will tell you, Mr. Chairman, every time I 

come to one of these hearings you are holding I walk away thinking 

what can I eat, you know, or what vitamins should I take, or what 

prescription should I avoid. And it is just very troubling, and yet 

we know overall our food supply is pretty darn safe and secure. But 

so I think we are trying to find out where the hole is. Where are 

the breaches? What do we need to fix here? When you think of how 

much food is produced and consumed without any problem. I mean 

these are kind of along the edges, but it is not along the edge when 

it is your son or daughter that is hooked up to feeding tubes or 

dies. And that is—we want to get to zero tolerance. And it sounds 

like most importantly we need a better inspection regime and more 

inspectors. It sounds like, at least with FDA and probably USDA, 

we need more real time intelligence capabilities. It shouldn’t take 

eight months after Canada figures it out and probably a year after 

South Korea figures it out. Far after data reaches similar conclusion on a known carcinogen. I mean we are not the legislative committee. We are just the oversight committee, but we all serve on 

the committee that has legislative authority. What else can you 

offer us that you haven’t already in terms of what we need to do? 

Mr.WILLIAMS. Well, I think just about everything in our 11 point 

program would—we feel it would be very—would take care of this. 

Mr.WALDEN. All right. 

Mr.WILLIAMS. As far as seafood, imported seafood. And I think 

another example would be Cambodia. When the European Union 

went over there and found they had no, absolutely no, safety standards at all and would not allow their shrimp into the European 

Union, we continued to accept them. 

Mr.WALDEN. We did what? 

Mr.WILLIAMS. The FDA allowed them into this country. Our imports went up most like the Pakistani issue. 

Mr.WALDEN. See, that is encouraging. That is encouraging. We 

haven’t touched on the issue of radiation in beef. Does somebody 

want to tackle that one? Because I hear a lot that, you know, that 

could actually eliminate a lot of the disease. Mr. Marler, would that 

help? 

Mr.MARLER. Yes. 

Mr.WALDEN. Should we be doing that? 

Mr.MARLER. Yes. 

Mr.WALDEN. Is there any consumer issue with that? 

Mr.MARLER. I think the consumer issue with it, I think the 

science isn’t there to support the fear, but there is a fear. But 

we—— 

Mr.WALDEN. Right. 

Mr.MARLER [continuing]. Radiate a lot of products. 

Mr.WALDEN. And the practical effect of that is what? 

101 

Mr.MARLER. None. 

Mr.WALDEN. Other than that? 

Mr.MARLER. I mean other than eliminating or certainly reducing 

pathogens. The gentleman who talked about, you know, getting 

corn out of his field and eating the way we ate in the ’50s and ’60s, 

those days are long gone. 

Mr.WALDEN. Right. 

Mr.MARLER. And I think when our food chain is longer and more 

complex we have to look at interventions to protect us from pathogens that change on a daily basis. 

Mr.WALDEN. You know those days are long gone, but perhaps our 

inspection regime is still stuck there. 

Mr.MARLER. I would agree with you on that. 

Mr.WALDEN. It is sort of like a car in Cuba, you know, they have 

got the best mechanics in the world because they keep those 50- 

year-old cars running, and or more. Thank you, Mr. Chairman. I 

am going to yield back to get onto the next panel. 

Mr.STUPAK. On your radiation this committee has a joint request 

in right with GEO just waiting for the report back. It is something 

that we have looked at as part of the total food safety issue. 

Mr.WALDEN. Perfect. Thank you, Mr. Chairman. 

Mr.STUPAK. Ms. DeGette, for questions. 

Ms.DEGETTE. Thank you very much, Mr. Chairman. Mr. Williams, your testimony got me to thinking about something I say 

quite often in these hearings. And that is it seems—and I think the 

shrimp industry’s probably one of the best examples of how our entire food—or actually all of our consumer goods including food. 

Thirty years ago most of that food was domestically produced, and 

now a huge percentage is coming from overseas. And I frankly 

think that is one of the main reasons why our oversight agencies, 

like the FDA and the USDA, have broken down, because they are 

being asked to inspect things that they weren’t asked. Would you 

agree with that statement? 

Mr.WILLIAMS. Somewhat, yes. 

Ms.DEGETTE. In your industry, over the last say 30, 40 years, 

what is the percentage—how have you seen the percentage of imports change? 

Mr.WILLIAMS. It is since—actually since the late ’90s we have 

been losing—— 

Ms.DEGETTE. If you can move that microphone a little. 

Mr.WILLIAMS. Since the late ’90s we have been losing more market share, especially since 2000, because of we feel like the lack of 

inspection for the imports. These products—this product is allowed 

to come in and capture our market. We are down to about 10 percent of our entire market now. We feel like if those shrimp were 

inspected they would not be allowed to come into the Nation, because they are contaminated. They are contaminated with illegal 

antibiotics, and they shouldn’t be in this market. 

Ms.DEGETTE. And one reason why people are buying them is 

they are cheaper than domestically produced shrimp. 

Mr.WILLIAMS. That is right. 

Ms.DEGETTE. Correct? And I would assume your industry’s position is they’re cheaper because they are not raised under the same 

strict standards your industry sets forward, correct? 

102 

Mr.WILLIAMS. That is right. We are wild caught domestic industry. We can produce and compete with anyone in the world. We always have until they started breaking the rules. And that is what 

they have done is break the rules and put our industry in jeopardy. 

We have—— 

Ms.DEGETTE. And do you think that there is more consumer 

risks to these imported shrimp as well. 

Mr.WILLIAMS. Oh, yes, definitely. I had a—and this may be extreme, but I had a gentleman—when we started this early on we 

filed these trade petitions against these countries, and one of them 

was because of the chemicals. I had a rep from a chemical company. He was a salesman for years and years. And he told me that 

some of these chemicals such as chloramphenicol you really don’t 

want to touch this product without rubber gloves on. 

Ms.DEGETTE. Great. Now, Dr. Greger, one thing. I hope no one 

asked this, and I apologize, in my absence. You—one thing that 

struck me about that really horrifying video is that the USDA inspectors were actually at that plant twice a day. I think they said 

what, 6:30 a.m. and 12:30 p.m. Were those inspectors on site? 

Dr.GREGER. There have to be inspectors on site—— 

Ms.DEGETTE. OK. 

Dr.GREGER [continuing]. One-hundred percent of the time inside 

on the line, but not necessarily off-line inspectors or in the holding 

pens or in that area. And that is why something like closed circuit 

television—— 

Ms.DEGETTE. Right. 

Dr.GREGER [continuing]. Camera or random checks. 

Ms.DEGETTE. But let me stop you right there. 

Dr.GREGER. Yes. 

Ms.DEGETTE. What were those inspectors doing the rest of the 

time between when they went out there? 

Dr.GREGER. And so inspectors were either inspecting other plants 

or were inside. 

Ms.DEGETTE. So those two inspectors—or however many inspectors there were, they weren’t on that particular site all day long? 

Dr.GREGER. That—there was one inspector came the same time, 

same two times every day, but I am not sure where that inspector 

was at other times. Whether they were at that plant or looking at 

other plants. 

Ms.DEGETTE. I see. OK. We had been under the impression there 

were inspectors on site during the whole work day. That is not correct. 

Dr.GREGER. There are USDA inspectors inside the plant watching the carcasses. 

Ms.DEGETTE. But they are different inspectors? 

Dr.GREGER. There are on-site inspectors and on-line inspectors. 

Ms.DEGETTE. OK. 

Dr.GREGER. Excuse me. And off-line inspectors. For a plant to operate there has to be someone—there has to be a federal inspector 

looking at the carcasses, but there does not necessarily have to be 

an inspector watching the unloading and treatment of the animals 

before slaughter. 

Ms.DEGETTE. OK. 

103 

Dr.GREGER. They have a mandate to do that, but evidently they 

don’t have the—— 

Ms.DEGETTE. The resources. 

Dr.GREGER [continuing]. Personnel. 

Ms.DEGETTE. But both you, and also Mr. Marler, said that you 

could solve some of these problems with technology. And I would 

suspect too, Mr. Williams, in the shrimp industry we are going to 

have to get—this is true. We have been doing all these consumer 

product hearings and food hearings, and I mean frankly our food 

inspection and consumer products inspection systems are completely broken. But there is also no way we could ever have enough 

of a budget for every single lot of meat or every single lot of shrimp 

to be inspected. So I think one of the challenges that we have to 

face, we are in the 21st century, is to find innovative testing that 

is like these video surveillance cameras and other types of testing. 

Wouldn’t you agree with that, any of you? 

Mr.WILLIAMS. I would agree, but also agree that it should begin 

in the exporting nations. That is where it should begin. 

Ms.DEGETTE. Yeah. Well, the last I heard the U.S. Congress 

doesn’t have very much jurisdiction over the Chinese food business. 

But if we can figure that out I think we will be a big step ahead. 

Thank you so much, Mr. Chairman. 

Mr.STUPAK. Well, thank you. That concludes all the questions for 

this panel. We want to thank this panel. Before we leave, you 

know, we learned a lot about—this is our fifth food safety hearing, 

and a lot about imports. And Richard Wilfong, who is a detainee 

from another department agency, ICE, the Immigration and Customs Enforcement, will be leaving us. And, Richard, I just want to 

thank you for all your work in helping us understand the import 

business as you do. It makes all of us members who ask questions—the brains behind the operation are really sitting behind us 

and helping us out. And that goes on both sides. We have got a 

great staff. So I want to compliment the staff before we dismiss 

this panel and before we call up our next panel. And thank you to 

this panel for all of your insight. Thank you. 

Mr.WILFONG. Thank you. Thank you very much. 

Mr.STUPAK. I will now call up our second panel of witnesses. On 

our second panel we have Mr. Gary M. Rodkin, Chief Executive Officer of ConAgra Foods. Mr. B. Keith Shoemaker, President and 

CEO of Butterball. Mr. Christopher D. Lischewski, President and 

CEO of Bumblebee Foods. Mr. Rick Ray, President and CEO of 

New Era Canning Company. Mr. David DeLorenzo, President and 

Chief Executive Officer of Dole Food Company. Mr. David A. 

Eisenberg, Chairman of ANRESCO Laboratories, and Dr. Robert E. 

Brackett, PhD., Senior Vice President and Chief Science Regulatory 

Affairs Officer at the Grocery Manufacturers Association. 

I think we are just waiting for one more. OK. 

[Witnesses sworn.] 

Mr.STUPAK. You are now under oath, and we will begin opening 

statements. Please, limit it to 5 minutes. If you have a longer statement we will include it in the record. 

Mr. Rodkin, we will start on my left, if you would like to start. 

I am going to ask you to pull that mic up. Pull it towards you. If 

104 

we get it closer we can hear it a little better. It is not the best system in this room. Thanks. 

STATEMENT OF GARY M. RODKIN, CHIEF EXECUTIVE 

OFFICER, CONAGRA FOODS, INC. 

Mr.RODKIN. Good morning, Mr. Chairman and members of the 

committee. 

My name is Gary Rodkin, and I am the chief executive officer for 

ConAgra Foods. Thank you for the invitation to testify today about 

the safety of our Nation’s food supply. I became ConAgra Foods’ 

CEO in October of 2005, and during my tenure we have made food 

safety a top priority throughout our company. We fully agree with 

the committee’s objective of ensuring that our Nation’s food supply 

is among the safest in the world. 

I am pleased to report back to the committee on progress made 

with our Peter Pan peanut butter since our vice president for operations testified before you in April of last year, and how we have 

responded to new challenges with other products. I want to assure 

you how seriously we take our food safety responsibilities, and that 

this is a top priority throughout our company. As the CEO of the 

company whose core mission is to provide the consumers with safe, 

nutritious and wholesome food, the very possibility that one of our 

products could cause anyone harm is the very last thing that I 

would want to happen. I want to reiterate how truly sorry we are 

for any harm that our recalled peanut butter or pot pie products 

may have caused any consumer. 

Today I want to convey three main messages to the committee. 

One, ConAgra Foods has followed through on our commitments 

made here last spring regarding steps needed to resume production 

of our Peter Pan peanut butter by creating a state-of-the-art manufacturing facility in Sylvester, Georgia. In fact, that plant successfully resumed operations in August 2007. Two, ConAgra Foods addressed a completely different type of food safety concern with our 

Banquet and store brand pot pies in October 2007. We have since 

resumed operations after making enhancements to that product 

line. And three, ConAgra Foods has undertaken a complete revamping and modernization of our food safety practices companywide with the benefit of outside experts and the full commitment 

from all our food safety program managers. Our foremost goal is 

to prevent food safety problems from occurring, but should they 

ever occur we will continue to act quickly and responsibly to protect consumers and make any needed safety improvements. 

Throughout this process we have cooperated with the committee’s investigation and will continue to do so. We have provided the 

subcommittee with written testimony that contains additional detail on the first two product specific messages so I will not repeat 

those here. Rather, I would like to focus my time speaking to you 

directly on our final message regarding our companywide food safety modernization efforts. Namely, that ConAgra Foods is conducting a companywide upgrade of our food safety programs and 

will make continuous improvements to ensure that we provide safe 

food to consumers. As we reported to the committee last spring 

ConAgra Foods is committed to a companywide process to continuously improve our food safety programs starting with our hiring of 

105 

a new chief global quality officer and the establishment of a food 

safety advisory committee. We have since taken the process much 

further and have undertaken the following steps. First, we are 

making a major investment in facility upgrades and in hiring additional quality personnel throughout the company. Specifically we 

have earmarked millions of dollars in capital for our facilities for 

projects that will further enhance the safe manufacture of our 

products. We are also in the process of hiring an additional 250 

quality personnel companywide primarily to support our enhanced 

food safety standards at our facilities. Second, we have made a 

major commitment to enhanced training in our food safety requirements for all of our plant personnel and suppliers. Specifically, in 

September of last year we convened a meeting of every plant manager and every quality manager at our headquarters facility in 

Omaha, which I attended, to launch an enterprise-wide set of food 

safety improvements. We are conducting continuous food safety and 

quality training for all plant employees companywide. We have also 

reached out to our co-packers and plan to hold a food and safety 

quality intervention event with all key supervisors and contract 

packers in the very near future. Finally, we are conducting continuous safety audits across all plants with a particular focus on one, 

incoming ingredient quality programs; two, allergen and sanitation 

programs; three, foreign material control programs; and four, overall infrastructure. By the end of the year we will have reassessed 

every HACCP plan across all of our platforms. We have also created within ConAgra Foods a new microwave center of excellence— 

center of expertise, and have begun a review of cooking instructions 

across all of our products. 

In conclusion, we appreciate the committee’s interest in food 

safety, and we fully support the committee’s goals. At ConAgra 

Foods we have met the commitments we made to the committee 

last spring regarding the process to be followed before resuming operations of peanut butter manufacturing at our Georgia facility. We 

responded quickly to an unexpected outbreak related to our pot 

pies, and we are well into a companywide process to review and upgrade our food safety programs for our entire business. 

I want to emphasize that these improvements are ongoing and 

will continue. I personally will ensure that we will continuously 

challenge and improve our food safety programs and make certain 

that food safety is the centerpiece of our corporate culture. Thank 

you. 

[The prepared statement of Mr. Rodkin follows:] 

STATEMENT OF GARY M. RODKIN

Good Morning Mr. Chairman and Members of the Committee. My name is Gary 

M. Rodkin, and I am the Chief Executive Officer (CEO) for ConAgra Foods, Inc. 

(ConAgra Foods). Thank you for the invitation to testify today about the safety of 

our nation’s food supply. I became ConAgra Foods’ CEO in October of 2005 and, during my tenure, we have made food safety a top priority throughout our company. 

We fully agree with the Committee’s objective of ensuring that our nation’s food 

supply is among the safest in the world. 

ConAgra Foods is one of North America’s leading packaged food companies, serving grocery retailers, as well as restaurants and other foodservice establishments. 

Popular ConAgra Foods consumer brands include: Chef Boyardee, Egg Beaters, 

Healthy Choice, Hebrew National, Hunt’s, Marie Callender’s, Orville Redenbacher’s, 

PAM and many others, including Peter Pan and Banquet. We operate more than 

106 

100 manufacturing facilities in 30 states, as well as facilities in several international locations. 

I am pleased to be able to report back to the Committee on progress made with 

our Peter Pan peanut butter since our Senior Vice President for Operations testified 

before you in April of last year, and how we have responded to new challenges with 

other products. I want to assure you how seriously we take our food safety responsibilities and that this is a top priority throughout our company. As the CEO of a 

company whose core mission is to provide consumers with safe, nutritious and 

wholesome food, the very possibility that one of our products could cause anyone 

harm is the very last thing that I would want to happen. I want to reiterate how 

truly sorry we are for any harm that our recalled peanut butter or pot pie products 

may have caused any consumer. 

Today, I want to convey three main messages to the Committee. One, ConAgra 

Foods has followed through on our commitments made here last spring regarding 

steps needed to resume production of our Peter Pan peanut butter by creating a 

state-of-the-art manufacturing facility in Sylvester, Georgia. In fact, that plant successfully resumed operations in August 2007. Two, ConAgra Foods addressed a completely different type of food safety concern with our Banquet and store brand pot 

pies in October 2007. We have since resumed operations after making enhancements to that product line. And three, ConAgra Foods has undertaken a complete 

revamping and modernization of our food safety practices company wide, with the 

benefit of outside experts and the full commitment from all our food safety program 

managers. Our foremost goal is to prevent food safety problems from occurring, but 

should they ever occur, we will continue to act quickly and responsibly to protect 

consumers and make any needed safety improvements. Throughout this process, we 

have cooperated with the Committee’s investigation and will continue to do so. Let 

me now describe these three points in greater detail. 

1. ConAgra Foods has followed through on its commitments to this Committee by making its peanut butter manufacturing plant in Sylvester, Georgia a state-of-the-art facility before resuming operations in August 2007. 

When ConAgra Foods testified before this Committee in April 2007, we committed 

to addressing the suspected causes of the contamination at our Sylvester, Georgia 

facility that manufactures Peter Pan peanut butter, and to implement significant 

changes in the plant, including new, state-of-the-art machinery, technology, and designs throughout the facility. We further committed, prior to resuming operations, 

to obtain an independent review by an expert third-party and seek the concurrence 

of the Food and Drug Administration (FDA) as to the adequacy of the measures implemented. We have met each of these commitments, and our Sylvester plant resumed operations in August 2007 as a state-of-the-art facility. 

Specifically, with the assistance of our outside experts, we took the following 

steps: 

a. We made a significant capital investment (approximately $40 million) to substantially upgrade the Sylvester facility. This included: (1) installation of a new 

roaster; (2) installation of a new roof; (3) physical separation and segregation of raw 

material and finished product areas and activities (each with dedicated employees 

and equipment) to minimize possible cross-contamination; (4) dedicated equipment 

wash rooms for raw and finished areas; (5) upgraded air flow systems; and (6) enhanced quality control systems supported by additional quality personnel. 

b. We enhanced both the frequency and sensitivity of our environmental and finished product testing programs for this facility, and assigned responsibility for sample testing to an independent, accredited laboratory. 

As we made these changes, we kept FDA informed of our progress. Once the plant 

was fully operational, FDA conducted a multi-day, on-site inspection of the Sylvester 

facility and was satisfied with the overall condition of the facility. We believe that 

we have created an industry-leading, state-of-the-art facility for manufacturing peanut butter. We have also used this process as a springboard to assess and improve 

our food safety operations throughout the company. 

2. ConAgra Foods responded quickly to a government finding in October 

2007 that its Banquet and store brand pot pies had been implicated in a 

salmonella outbreak and has implemented necessary steps to improve the 

safe consumption of this ‘‘ready-to-cook’’ product. 

In October 2007, we faced a very different kind of food safety challenge with our 

Banquet and store brand pot pies produced at our Marshall, Missouri plant which 

manufactures, among other products, pot pies in the turkey, chicken and beef varieties. Unlike peanut butter which is sold to consumers as a ‘‘ready-to-eat’’ product, 

pot pies are sold to consumers as a ‘‘ready-to-cook’’ product, meaning the product 

needs to be fully cooked prior to consumption. This cooking process, whether in a 

conventional or microwave oven, further assures the safety of the product by effecVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00112 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
107 

tively killing any bacteria that may possibly be present. We were therefore surprised to learn from the United States Department of Agriculture (USDA) that this 

product line had been implicated in a salmonella outbreak. 

Nevertheless, we responded quickly. We suspended our pot pie manufacturing and 

distribution operations immediately upon learning of the outbreak on October 8, 

2007. We promptly commenced environmental sampling and testing within the 

plant, followed by our issuance of a consumer advisory and, ultimately, a voluntary 

recall of all of our Banquet and store brand turkey, chicken and beef pot pie products. All of these actions were taken in close cooperation with USDA’s Food Safety 

and Inspection Service (FSIS), which has primary jurisdiction because these pot pies 

are meat and poultry-based. 

Our investigation into the root cause started with extensive laboratory testing of 

both environmental and finished product samples. Each of our 577 environmental 

samples tested negative for salmonella. We also conducted 219 laboratory tests of 

our ingredients, which were also all negative. We undertook testing of 2968 samples 

of finished product, which yielded 17 positives for the outbreak strain. All of those 

positives related only to Banquet turkey pot pies from the production dates July 13, 

2007 and July 31, 2007. 

As noted, because pot pies are a ‘‘ready-to-cook’’ product, salmonella had never 

been deemed a ‘‘hazard’’ in the context of our Hazard Analysis Critical Control 

Points (HACCP) plans, and we believe this to be so throughout the industry. Following this incident, however, we revised our HACCP plans to recognize salmonella 

as a potential hazard and to require Certificates of Analysis from our suppliers demonstrating that all ingredients are free of salmonella. We also instituted finished 

product testing for salmonella by an independent laboratory. Finally, we have instituted a multitude of process and equipment changes at the plant. 

Our investigation also led us to learn a great deal more about microwave ovens 

and to determine that consumers needed much clearer directions for use on the 

product labels. In particular, we learned there is both a greater variability in the 

performance of microwave ovens than we were previously aware, as well as a lack 

of full understanding with respect to microwave cooking efficacy. Consequently, we 

made major changes to our on-pack cooking instructions to address these learnings 

with considerable specificity. These changes include a more prominent statement on 

the front and side panels that the product ‘‘Must Be Cooked Thoroughly. See Back 

for Directions.’’ In addition, we have devoted most of the back panel to step-by-step 

microwave cooking instructions that include: (a) minimum wattage for microwave 

ovens (1100 watts); (b) proper cooking time (4-6 minutes); and (c) consumer-friendly 

ways to know when the product is cooked thoroughly, such as the visual cue ‘‘Crust 

is golden brown and steam rises from filling.’’ To reinforce these messages, we added 

safe microwave cooking guidance on our website, conducted a satellite media tour 

that encouraged news stations to carry a news feature that further educated consumers about safe cooking in microwaves, and provided further training on the subject to our consumer affairs representatives who field calls from consumers. 

Moving forward, we have engaged the National Center for Food Safety Technology 

at the Illinois Institute of Technology (often referred to as the Moffett Center) to 

undertake cooking tests and research on the use of microwaves to cook frozen foods. 

We have also engaged the American Frozen Food Institute in the process and have 

urged the food industry as well as microwave manufacturers to address the cooking 

issues associated with microwave ovens through improved cooking instructions and 

clear information regarding microwave oven wattages. 

Throughout the investigation, we were in constant communication with the USDA 

and the Centers for Disease Control and Prevention (CDC). We shared with them 

on a real time basis all of our test data and the results of our investigative efforts. 

We worked closely with USDA on improvements that needed to be made. With the 

concurrence of USDA, we resumed production of our Banquet brand pot pies in November, 2007. 

Having now been involved in two very different food safety outbreaks, we are 

more determined than ever to follow through on our commitment to improve our 

systems company wide to ensure we are producing safe, wholesome, quality products, whether they are ‘‘ready-to-eat’’ or need to be further cooked by consumers. 

3. ConAgra Foods is conducting a companywide upgrade of our food safety programs and will make continuous improvements to ensure we provide 

safe food to consumers. 

As we reported to the Committee last spring, ConAgra Foods is committed to a 

company wide process to continuously improve our food safety programs, starting 

with our hiring of a new Chief Global Quality Officer and the establishment of a 

Food Safety Advisory Committee. We have since taken the process much further 

and have undertaken the following steps. 

108 

First, we are making a major investment in facility upgrades and in hiring additional quality personnel throughout the company. Specifically, we have earmarked 

millions of dollars in capital for our facilities for projects that will further enhance 

the safe manufacture of our products. We also are in the process of hiring an additional 250 quality personnel company wide, primarily to support our enhanced food 

safety standards at our facilities. 

Second, we have made a major commitment to enhanced training in food safety 

requirements for all of our plant personnel and suppliers. Specifically, in September 

of last year, we convened a meeting of every plant manager and every quality manager at our headquarters facility in Omaha to launch an enterprise-wide set of food 

safety improvements. We are conducting continuous food safety and quality training 

for all plant employees, company wide. We have also reached out to our co-packers 

and plan to hold a food safety and quality intervention event with all key supervisors and co-packers in the very near future. 

Finally, we are conducting continuous food safety audits across all plants, with 

a particular focus on: (1) incoming ingredient quality programs; (2) allergen and 

sanitation programs; (3) foreign material controls programs; and (4) overall infrastructure. By the end of this year, we will have reassessed every HACCP plan 

across all of our platforms. We have also created within ConAgra Foods a new 

Microwave Center of Expertise and have begun a review of cooking instructions 

across all products. 

In conclusion, we appreciate the Committee’s interest in food safety, and we fully 

support the Committee’s goals. At ConAgra Foods, we have met the commitments 

we made to the Committee last spring regarding the process to be followed before 

resuming operations of peanut butter manufacturing at our Sylvester, Georgia facility. We responded quickly to an unexpected outbreak related to our pot pies. And 

we are well into a company wide process to review and upgrade our food safety programs for our entire business. I want to emphasize that these improvements are ongoing and will continue. I personally will ensure that we continuously challenge and 

improve our food safety programs, and make certain that food safety is a centerpiece 

of our corporate culture. 

Mr.STUPAK. Thank you. Mr. Shoemaker, your testimony please. 

STATEMENT OF B. KEITH SHOEMAKER, PRESIDENT AND CEO, 

BUTTERBALL, LLC 

Mr.SHOEMAKER. Thank you, Mr. Chairman. I am Keith Shoemaker, Chief Executive Officer of the Butterball, LLC. Butterball 

was formed in 2006 when Carolina Turkey purchased the Butterball brand from ConAgra Refrigerated Food. Butterball is the best 

known brand in the turkey industry. Food safety is to be job one. 

Let me make it clear that the food safety investigation regarding 

salmonella in ConAgra turkey pot pies suggested that Butterball 

turkey was not the source of production contamination. I would like 

to clarify information reported in the media. No Butterball, LLC 

product has been recalled. Butterball complies with all USDA requirements. USDA food safety officers are present in Butterball facilities on a daily basis. However, my company does not rely on federal inspection to ensure the safety of our products. At Butterball 

we go beyond federal regulations by using the latest food safety 

technologies, comprehensive food safety practices and stringent 

microbiological surveillance. 

Permit me to explain how our food safety practices apply to ingredients, cooking, packaging and handling. Our requirements include stringent food safety practices for the handling of raw materials. It is generally recognized that raw meat, especially poultry 

meat, may contain salmonella. Science states salmonella does not 

grow below 44 degrees Fahrenheit, and will not typically grow 

below 50 degrees. That is why Butterball monitors and controls the 

temperature of our meat to less than 40 degree Fahrenheit and the 

109 

room temperature to less than 44 degrees. This is a common industry practice to slow or stop the growth of bacteria in raw turkey. 

The fact that Butterball raw materials are received from one of our 

own slaughter and debone facilities allows us to assure temperature control throughout the supply chain. Serving to keep the level 

of bacterial growth at a minimum prior to meat being cooked. Data 

generated by USDA from Butterball facilities indicates a very low 

presence of salmonella. In fact, facilities supplying the raw product 

have been identified by FSIS as demonstrating the best control for 

salmonella. The turkey products supplied to ConAgra is fully 

cooked, ready to eat, cooked in a bag turkey logs. Cooked in a bag 

products are generally considered one of the lowest risk meat products. Possible contamination of the product after cooking is prevented by the fact that the product is protected from environmental 

exposure subsequent to cooking. 

That should help explain why the investigations regarding the 

ConAgra recall found no data to support that Butterball turkey 

meat is the likely source of salmonella identified in the outbreak. 

The turkey log we provided to ConAgra was made from our own 

raw materials, stuffed into packaging material, thorough cooked to 

kill bacteria that may be present. By packaging prior to cooking we 

prevent possible contamination after cooking. The food safety investigation regarding the recall confirms the effectiveness of these systems. No salmonella of the type that contained within the pot pies 

has ever been found in a Butterball facility. With cooked in the bag 

product the cook step is critical to the safety of the product. To ensure maximum food safety USDA requires a minimum of 160 degrees Fahrenheit instantaneously. At Butterball we do more. Specifically, these turkey logs are exposed to 162 degrees Fahrenheit 

for between 15 to 20 minutes. Our ovens include four computerized 

temperature probes that provide continuous readout. A calibrated 

hand held thermometer serves to verify product temperature as 

well. After cooking the cooked in the bag log is then shielded in 

temperature controlled as long as we have it. 

From the time the disease was first identified Butterball cooperated with ConAgra Foods and USDA in investigating the possible 

source of the salmonella. Between August and October of ’07, 

USDA conducted three major reviews of the Jonesboro facility and 

ConAgra conducted two more. There were no significant food safety 

findings in any of these reviews. 

In our own inquiry, Butterball conducted intense microbiological 

testing. Again, all results were negative. In short, at the conclusion 

of the investigations, logs were fully cooked and the product in the 

package was likely not the source of outbreak. 

Mr. Chairman, we at Butterball are eager to take every practical 

step to assure food safety for our customers. We have worked cooperatively with this committee and all other investigators and highly 

respect the experts. We remain eager to continue such efforts in 

the interest of future food safety. 

Finally, Mr. Chairman, I would like to thank the committee for 

its efforts to advance food safety and interest in learning about food 

science principals that guide our practices. We at Butterball would 

be pleased for you to tour one of our facilities to learn more about 

our operations. Thank you. 

110 

[The prepared statement of Mr. Shoemaker follows:] 

STATEMENT OF KEITH SHOEMAKER

SUMMARY

1. BUTTERBALL TURKEY NOT IMPLICATED. The food safety investigations 

regarding Salmonella in ConAgra turkey pot pies suggest that the Butterball turkey 

ingredient in those pot pies was NOT the source of product contamination. 

2. INGREDIENT CONTROL. The turkey log Butterball provided to ConAgra was 

made from our own raw turkey, controlled to keep the level of bacterial growth at 

a minimum prior to the meat being cooked. Butterball facilities supplying the raw 

product have been identified by FSIS (USDA) as category one—‘‘demonstrating the 

best control for Salmonella.’’ 

3. SPECIAL PACKAGING. Cooked in bag products are considered one of the lowest risk meat products because cooking destroys pathogens and the product is not 

subject to environmental exposure subsequent to cooking. 

4. FULLY COOKED. Butterball cooks its turkey log to a higher temperature and 

holds that temperature longer than food safety requirements. Elaborate monitoring 

systems assure adherence to Butterball procedures to destroy pathogens. 

5. INVESTIGATIONS. The food safety investigations regarding the pot pie recall 

confirmed the effectiveness of these systems. Further, no Salmonella of the serotype 

that contaminated the pot pies has ever been found in a Butterball facility. Indeed, 

only once has that Salmonella serotype been found in turkey. 

6. BUTTERBALL COOPERATION. Butterball thanks the committee for its attention to food safety and invites Members and staff to tour a Butterball facility. 

TESTIMONY

Thank you Mr. Chairman. My name is Keith Shoemaker, and I am Chief Executive Officer for Butterball, LLC (Butterball). Butterball was formed in 2006 when 

Carolina Turkey of Mt. Olive, North Carolina, purchased the Butterball Brand from 

ConAgra Refrigerated Foods. Butterball produces over 1.4 billion pounds of turkey 

meat annually. 

At the outset, permit me to make clear that the food safety investigation regarding Salmonella in ConAgra turkey pot pies suggests that the Butterball turkey ingredient in those pot pies was NOT the source of product contamination. 

All Butterball products bear the mark of Federal Inspection, noting compliance 

with all United States Department of Agriculture (USDA) regulatory requirements. 

USDA Food Safety Officers are present in all Butterball facilities on a daily basis. 

However, my company does not rely on Federal Inspection to ensure the safety of 

our products. At Butterball, we go beyond federal requirements by using the latest 

food safety technologies, comprehensive food safety practices, and stringent microbiological surveillance. 

Food safety is top priority at Butterball, and I would like to focus my remarks 

today on our food safety practices. With specific reference to the turkey product used 

in the ConAgra turkey pot pies, permit me to explain how our food safety practices 

apply to ingredients, cooking, packaging, and handling. That should help explain 

why the investigations regarding the ConAgra recall have found no data to support 

the Butterball turkey meat is a likely source of the Salmonella identified in the pot 

pie illness outbreak. In short, the turkey log we provided to ConAgra was made 

from our own carefully controlled raw turkey, thoroughly cooked to kill Salmonella 

and other bacteria that may be present and packaged prior to cooking to prevent 

possible contamination after cooking has made the product safe. The food safety investigations regarding the pot pie recall confirmed the effectiveness of these systems. Further, no Salmonella of the serotype that contaminated the pot pies has 

ever been found in a Butterball facility. Indeed, only once has that Salmonella 

serotype been found in turkey. 

INGREDIENT CONTROL 

Our requirements include stringent food safety practices for the handling of the 

raw materials. It is generally recognized that raw meat, especially poultry, may contain Salmonella. Scientific literature states Salmonella does not show growth below 

44° F and will not typically grow below 50° F. That is why our company monitors 

and controls the temperature of the meat (<40F) and the room (<44F). This is a 

common industry practice and has been recognized to slow or stop growth of bacteria in raw turkey. The fact that Butterball raw materials are received from our 

own slaughter and debone operations allows us to assure temperature control 

111 

throughout the supply chain, serving to keep the level of bacterial growth at a minimum prior to the meat being cooked. 

USDA data confirms the effectiveness of Butterball Salmonella control procedures. 

Raw materials coming from our own slaughter facilities undergo USDA Salmonella 

testing. Data generated from Butterball facility indicate a very low presence of Salmonella. In fact, facilities supplying the raw product have been identified by FSIS 

as category one—‘‘demonstrating the best control for Salmonella.’’ 

SPECIAL PACKAGING 

The turkey product supplied to ConAgra is fully cooked, ready to eat, cooked in 

bag turkey log. To make this product, raw turkey meat is stuffed into the log packaging material and fully cooked in steam ovens. Packaging material for the turkey 

log is of a special design to allow the product to be fully cooked in the packaging 

without disrupting package integrity. Thus, it is called cooked in bag product. 

Cooked in bag products are generally considered one of the lowest risk meat products because pathogens (bacteria that cause illness) that may commonly be found 

on raw product are destroyed by cooking. Possible contamination of the product 

after cooking is prevented by the fact that the product is protected from environmental exposure subsequent to cooking. Listeria monocytogenes is generally considered the leading risk for environmental bacteria contamination from exposure after 

cooking. 

FULLY COOKED 

With the cooked in bag product, the cook step is critical to the safety of the product. The leading pathogen risk for raw poultry is Salmonella. All cook temperatures 

of products are targeted at reducing Salmonella 7 logs (a ‘‘log’’ is 10 organisms per 

centimeter squared; 7 logs is 10,000,000 organisms per centimeter squared). Studies 

conducted by industry, USDA, FDA, and other scientific bodies, both internationally 

and domestically, recognize this as the necessary safety level to destroy the maximum amount of organisms. To achieve a 7 log reduction in products like turkey 

logs, USDA requires a minimum of 160° F <1 min. At Butterball, we do more. We 

cook our turkey logs to a higher internal temperature for a longer period of time. 

Specifically, our turkey logs are exposed to 162° F for between 15–20 minutes. This 

extra time and temperature is actually destroying far more than 7 logs of Salmonella required. 

To be sure we actually meet our cooking specifications, our ovens include four 

computerized temperature probes that provide continuous read-out. Alarms sound 

on the oven when all probes reach 162° F. A calibrated hand-held thermometer 

serves to verify product temperature, as well. 

PRODUCT HANDLING 

Immediately after cooking, the cooked in bag turkey log is then taken into coolers 

and chilled to the appropriate temperature and maintained at that temperature as 

long as we have it. 

FOOD SAFETY INVESTIGATIONS 

From the time the foodborne disease outbreak was first identified, Butterball cooperated with ConAgra Foods and USDA to investigate the possible source of the 

Salmonella. Several audits of records, facility, cooking, and food safety practices 

were conducted. 

A review of the inspectional record was reassuring. 

• August 2007—The Jonesboro facility had only recently undergone the USDA 

Food Safety Assessment, completed, with no major finding. 

• October 6, 2007—USDA came back into the facility for another review, again 

with no findings reported. 

• October 25, 2007—USDA took fifteen microbiological swabs of the processing environment, all reported negative for the presence of the Salmonella. 

In our own inquiry, Butterball conducted intensified microbiological testing including turkey logs ready for shipment, combo bins used for shipping the log and 

the trailers used for shipping again, all results were negative. 

A ConAgra review team came to the facility October 14 and 15 to review records 

and production practices. No adverse findings were identified. On October 31 another team of ConAgra representatives, including outside experts, came to the facility to further investigate production practices associated with the oven operation. 

Butterball routinely calibrates the ovens and shared this information and the finding with the ConAgra review team. Again, there were no adverse findings noted. 

Additionally, at the request of ConAgra, a third party went into Jonesboro and 

validated each oven in the facility. The results of the third-party testing indicated 

that the ovens were functioning as they should, and the cooking cycles were far exceeding the lethality targets outlined in the food safety plan. 

Finally, a review of Salmonella testing data serotypes from USDA illustrates that 

no Salmonella of the serotype that contaminated the ConAgra turkey pot pies (SalVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00117 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
112 

monella I 4,[5],12:i:-) has ever been identified in a Butterball facility. Scientific literature available on this particular serotype notes it is commonly associated with 

chickens. USDA data shows only one incident of this serotype in turkey over several 

years of testing. That was not a Butterball turkey. 

In short, the conclusion of the investigation: the logs were fully cooked, and the 

product in the package was likely not the source of the outbreak. 

**** 

Mr. Chairman, we at Butterball are eager to take every practical step to assure 

food safety for our consumers. We have worked cooperatively with this committee 

and all other investigators and highly respected experts. We remain eager to continue such efforts in the interest of further improving food safety. 

Finally, Mr. Chairman, I would like to thank the committee for its efforts to advance food safety and interest in learning about the food science principles that 

guide our practices. We at Butterball would be pleased for you to tour one of our 

facilities to learn more about our operations. 

Thank you. 

Mr.STUPAK. Thank you. Mr. Lischewski. 

STATEMENT OF CHRISTOPHER D. LISCHEWSKI, PRESIDENT 

AND CEO, BUMBLE BEE FOODS, LLC 

Mr.LISCHEWSKI. Mr. Chairman and members of the committee, 

my name is Chris Lischewski, President and CEO of Bumblebee 

Foods and Castleberry’s Food Company. 

I appreciate the opportunity to be here today to provide my testimony and to respond to the committee’s questions related to the recall of canned products of Castleberry’s Food Company due to the 

risk of botulism contamination. 

First, I would like to say that we are in the business of providing 

wholesome food products to the public and making sure that our 

food is safe is always our first priority. Previously food that had to 

be recalled was the worst thing we could have faced, and we deeply 

regret that it occurred. We have tried to deal with the situation in 

a manner that reflects our sense of responsibility, our understanding of the gravity of the situation, our desire to make whole 

all the purchases of our recalled products and our continuing commitment to ensuring that all of our products are safe for consumers. 

Upon learning of possible botulism contamination from FDA and 

the CDC Castleberry’s immediately instituted a voluntary recall of 

10 products. To further minimize the risk to public health we 

quickly expanded the recall to extend beyond the specific products 

and production dates linked to apparent cases of illness. And ultimately our product recall included over 90 products produced over 

a two year period. We also voluntary ceased production at our operating facility in Augusta. We informed the public about the recall 

through extensive public awareness programs in both English and 

Spanish. Frequent press releases and advisories were issued and 

multiple press conferences were held. The consumer hotline was established and staffed around the clock with call center professionals. Our website was updated. Advertisements ran in regional 

and national newspapers, direct mailing were sent to consumers 

and warnings were even printed on cash register receipt printouts. 

And including and in addition to that we engaged in numerous 

interviews with the media. As of October of last year there had 

been nearly 5,000 broadcast stories on the recall, in large part generated by the company to drive public awareness. And we also 

113 

made it very easy for consumers to obtain refunds. No proof of purchase or return of product was required, and we just trusted the 

people to be honest with us. 

Retrieving recalled products in the marketplace was a large task, 

and we mobilized vast resources. I believe both FDA and USDA 

will confirm that we did everything they asked of us and more in 

order to notify retailers and consumers of the recall, and to quickly 

and safely remove product from the shelves. Upon announcement 

of the recall we immediately began by telephoning and e-mailing 

the contacts of all of our direct retail customers who had purchased 

any of the recalled products at any time during the previous two 

years. In addition to these ongoing telephone calls we sent nine 

company bulletins to these customers between July 18 and August 

15 to update them on the recall. In addition to our direct contact 

to retail customers we engaged a company called RMX to physically 

visit 18,619 stores during the 10 day period following the recall to 

confirm removal of the product from the store shelves. And we followed that up with another company called RMX to over the next 

60 days to cover 22,000 stores again. In less than one percent of 

the stores visited were recalled products on the shelf. We worked 

with customers that had loyalty card programs to send letters directly to consumers who had purchased recalled products. And, 

again, also engaged Catalina Marketing to run a program where by 

consumers who had previously purchased any recall product would 

receive on their register tape with the next purchase a warning notifying them of the recall. 

Throughout the recall we were in constant communication with 

the regulatory agencies establishing a daily conference call during 

the first few weeks of the recall to keep the agencies apprised of 

our efforts, to seek their input, and to provide answers to their 

questions. We also engaged an experienced consultant to advise us 

in any additional measures we might take. We worked openly and 

diligently to cooperate with FDA, USDA and this committee to facilitate all investigations including granting interviews and providing all documents requested. Together with processing authorities and regulatory experts we conducted an extensive, intensive 

investigation and identified the cause of the contamination. We 

have taken effective steps to prevent an occurrence and have also 

taken the opportunity to elevate our safety practices and procedures to an even higher level. In addition, we completed independent third party audits at all of our other facilities to ensure 

that appropriate procedures are in place. 

I truly appreciate the opportunity to come before you to discuss 

the recall, and hope that this can be a learning experience for all 

those involved in the industry where we work together to ensure 

that these types of incidents never happen again. Thank you. 

[The prepared statement of Mr. Lischewski follows:] 

STATEMENT OF CHRIS LISCHEWSKI

I’m Chris Lischewski, President and CEO of Bumble Bee Foods and Castleberry’s 

Food Company. I appreciate the opportunity to be here today to provide my testimony and to respond to the Committee’s questions related to the recall of canned 

products by Castleberry’s Food Company due to the risk of botulism contamination. 

First, I would like to say that we are in the business of providing wholesome food 

to the public. Making sure that our food is safe is always our first priority. ProVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00119 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
114 

ducing food that had to be recalled was the worst thing we could have faced, and 

we deeply regret that it occurred. We have tried to deal with the situation in a manner that reflects our sense of responsibility, our understanding of the gravity of the 

situation, our desire to make whole all of the purchasers of our recalled products, 

and our continuing commitment to ensuring that all of our products are safe for consumers. Upon learning of possible botulism contamination from FDA and CDC, 

Castleberry’s immediately instituted a voluntary recall of ten products. To further 

minimize the risk to the public health, we quickly expanded the recall to extend beyond the specific products and production dates linked to apparent cases of illness. 

Ultimately, over ninety products produced during a two-year period were recalled. 

The factory voluntarily ceased all production and distribution. 

We informed the public about the recall through an extensive public awareness 

program in both English and Spanish. Frequent press releases and advisories were 

issued, multiple press conferences were held, a consumer hotline was established 

and staffed around the clock with call center professionals, the Castleberry’s website 

was regularly updated (in both English and Spanish), advertisements ran in regional and national newspapers, direct mailings were sent to consumers, warnings 

were printed on cash register receipt print outs, and we engaged in numerous interviews with the news media. As of October of last year, there had been nearly 5,000 

broadcast stories on this recall in large part generated by the company to drive public awareness. Also, we made it very easy for consumers to obtain refunds-no proof 

of purchase or return of product was required. We trusted people to be honest with 

us. Retrieving the recalled product from the marketplace was a large task, and we 

mobilized vast resources. I believe FDA and USDA will confirm that we did everything they asked of us, and more, in order to notify retailers and consumers of this 

recall, and to quickly and safely remove products from store shelves. Upon announcement of the recall, we immediately began, by telephone and e-mail, to contact 

all of our direct retail customers who had purchased any of the recalled products 

at any time during the previous two years. In addition to these ongoing personal 

telephone calls and emails, we sent nine company bulletins to these customers between last July 18 and August 15, to update them on the recall and to provide additional information on things such as procedures for product retrieval and destruction. We engaged a contractor to retrieve and dispose of recalled product to avoid 

it being returned to the factory or to any of our distribution centers. 

In addition to our direct contact with our retail customers, we engaged a company 

called RMX to physically visit 18,619 stores during the ten-day period following 

commencement of the recall, to confirm removal of recalled product from store 

shelves. Then, as a follow-up to the RMX visits, we engaged the CORE retail team 

division of Advantage Sales & Marketing to further assess the effectiveness of the 

recall by visiting more than 22,000 stores during the next 60 days. In the less than 

1% of the stores visited where recalled product was found on a shelf, the CORE 

team worked with the stores to dispose of the product. We worked with customers 

that had loyalty card programs to send letters directly to consumers who had purchased recalled products. We also engaged Catalina Marketing to run a program at 

approximately 22,000 stores whereby consumers who had previously purchased any 

recalled product would receive on their register tape, at their next purchase, a warning notifying them of the recall and directing them to our website and hotline. 

Throughout the recall, we were in constant communication with the regulatory 

agencies, establishing a daily conference call during the first few weeks of the recall 

to keep the agencies apprised of our efforts, to seek their input and to provide answers to their questions. We also engaged an experienced consultant to advise us 

on any additional measures we might take. We did everything we reasonably could 

to get the recalled products off of store shelves and out of consumers’ kitchens. 

We worked openly and diligently to cooperate with FDA, USDA, and this Committee to facilitate all investigations, including granting interviews and providing 

all documents requested. Together with processing authorities and regulatory experts, we conducted an intensive investigation and identified the cause of the contamination. We have taken effective steps to prevent a recurrence, and have also 

taken the opportunity to elevate our safety practices and procedures to an even 

higher level. We also completed independent third-party audits at all of our other 

facilities, to ensure that appropriate safety procedures are in place. 

Following the completion of our investigation and implementation of improved 

preventative safety procedures, we prepared submissions to USDA and FDA documenting the findings of our investigation and seeking their approval of our plan to 

re-open the facility. Our SVP of Technical Services and other management from Augusta met with FDA officials in Washington on September 5, 2007, to discuss our 

115 

submission and to address any questions or concerns. At FDA’s request, we set up 

a conference call the next day with our process authority to address FDA’s questions. We received approval to re-open from FDA on September 12th and from 

USDA on September 14th. On September 17th, the plant re-opened. The line on 

which the recalled product was manufactured is not and will not be run until a further in-depth review has been completed and additional operational control systems 

have been reviewed for possible installation to provide more robust operating and 

monitoring systems for these complex retorts. 

I want to reiterate our deepest regret that this incident occurred. Consumer safety 

is of the utmost importance to our company and to its employees, including me. We 

have taken, and continue to take, this matter extremely seriously and personally. 

As we try to move forward from this experience, we do not forget those who were 

most affected. We are working with those individuals who contracted botulism to 

resolve their claims in a fair and amicable manner. 

I truly appreciate this opportunity to come before you to discuss the recall, and 

I hope that this can be a learning experience for all those involved in the industry 

as we work together to ensure that these types of incidents never happen again. 

Thank you. 

Major Points: 

• Upon learning of possible botulism contamination from FDA, Castleberry’s immediately instituted a voluntary recall, which was quickly expanded to extend beyond the specific products and production dates linked to apparent cases of illness, 

in order to minimize any potential risk to the public. The factory was voluntarily 

shut down. 

• With the assistance of a team of process authorities and regulatory experts, 

Castleberry’s conducted an intensive investigation and has identified the cause of 

the contamination, has taken effective steps to prevent a recurrence, and has taken 

the opportunity to elevate its safety practices and procedures to an even higher 

level. Bumble Bee initiated independent third party-audits of all of its other facilities. Those audits were all successfully completed last year, with no issues of significance. 

•Following the completion of our investigation, we worked together with FDA and 

USDA to obtain their approval to re-open the plant (other than the line on which 

recalled product was produced. 

• Castleberry’s worked diligently to cooperate with FDA, USDA and this Committee to facilitate all investigations, including granting interviews and providing 

documents. 

• Castleberry’s has gone beyond what was required by FDA, USDA and state 

agencies to ensure an effective recall. Efforts included website communications (both 

Spanish and English), media coverage (press releases, advertisements, press conferences and media interviews), customer calls, direct mailing to consumers, RMX/ 

ASM-CORE retail coverage, Catalina program, third-party product retrieval/destruction service. 

• Refunds were made easily available for consumers via our website without requiring return of product. 

• Castleberry’s is working with consumers who claim they contracted botulism 

from recalled products to resolve the claims. 

Mr.STUPAK. Thank you. 

Now, Mr. Ray, your testimony, please. 

STATEMENT OF RICK RAY, PRESIDENT AND CEO, NEW ERA 

CANNING COMPANY 

Mr.RAY. Good afternoon, Mr. Chairman and members of the committee. My name is Rick Ray and I serve as president of the New 

Era Canning Company. Thank you for your invitation to testify 

today. 

New Era Canning Company is a small fourth generation family 

owned fruit and vegetable canning operation located in New Era, 

Michigan. For the past 98 years New Era Canning has been serving customers in the retail and food service industry with high 

quality canned fruits and vegetables. The New Era name is not 

widely known because we serve primarily the private label or store 

116 

brand market. We operate a single facility and employ 50 full-time 

people as well as 100 to 200 seasonal employees during our processing seasons. We process asparagus, green beans, wax beans, applesauce, sliced apples, pumpkin and a variety of dry bean items. 

We have a long tradition of providing safe food products to our 

customers. We fully realize that we are accountable for every case 

of canned food that we produce. We take that responsibility seriously. Today New Era’s in the midst of a recall of our low acid 

canned vegetable products. The reason is that FDA discovered C. 

botulinum spores in New Era’s canned vegetables. 

In New Era’s 98 year history we have never previously experienced anything such as this. Permit me to explain what my scientific experts have told me about the classic concern regarding the 

C. botulinum contamination of canned foods, especially low acid 

canned foods. C. botulinum spores are ubiquitous. They originate 

in soil and, therefore, they are all around us. The spores are not 

harmful, but in the proper environment they can produce C. botulinum toxin which is highly toxic. In simple terms we are prudently 

assuming that C. botulinum spores will be naturally present in 

canned vegetable products. Thus, the most important step in canning is to bring the canned product to a sufficiently high temperature to kill the C. botulinum spores. Then to prevent overcooking 

the canned vegetables the cans are promptly cooked using water. 

The classic C. botulinum problem in canned vegetables occurs 

when some part of the product does not reach a killing temperature. In that situation the spores have been shocked, but not killed 

by the cooking. The shock to the spores prompts them to start 

growing and producing toxins. Unfortunately, low acid canned 

foods are a suitable environment for the growth of C. botulinum 

spores and the production of toxin. 

While our investigation is still under way and we have not yet 

received key information from the FDA about their findings, our 

scientific experts tell me that it appears that the classic C. botulinum situation is not what occurred at New Era. In the extensive 

sampling of New Era production, most of which we had on hold due 

to production irregularities, the C. botulinum spores, but not toxin 

was found. At least to date the C. botulinum found appears not to 

be a result of insufficient canning temperature to kill C. botulinum 

spores. Instead, it appears the presence of C. botulinum spores, but 

not toxin, in New Era canned vegetables is due to the entry of 

spores into cans during the cooling of the product after the can has 

been sealed and the product cooked. If the can seam is not to specification or becomes damaged microscopic—of cooling water can 

enter the can. This is why the industry has long used only safe 

drinking water in the can cooling. 

There are several reasons why this is the leading theory for the 

presence of C. botulinum in New Era canned vegetables. First, 

FDA tests of drinking water wells used by New Era for cooling 

water found that C. botulinum spores were present in the water. 

Second, the New Era processes that produced the contaminated 

product appear to have been achieving appropriate canning temperatures. Third, the presence of C. botulinum spores, but not toxins, suggests that the spores were not shocked by cooking temperaVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00122 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
117 

tures, which corresponds with the theory that the introduction of 

the spores was in the cooling water. 

In the scant scientific literature on the subject C. botulinum 

spores are regarded as so unlikely to be found in water that testing 

is not a standard procedure. 

Mr. Chairman, the investigations, however, are still under way, 

so this conclusion must be regarded as preliminary. The FDA investigation of our company began 11 weeks ago. Working with 

technical experts we are addressing all issues raised by the FDA, 

as well as investigating additional opportunities to improve our 

overall operation. While it appears that the spores that entered 

New Era products in this manner have not been shocked and did 

not produce toxin, that fact is not satisfactory to New Era, and for 

that matter the FDA. No C. botulinum spores that have the capacity to produce toxins should ever be present in our products. 

This has been a resource intensive and difficult process for New 

Era to experience. But it is our intent to determine the cause of 

the current problem and to take whatever measures are necessary 

to ensure a safe product. We are very thankful that, to the best of 

our knowledge, there have been no reported illnesses from any of 

our canned vegetables. Again, we are and always have been committed to our responsibility to produce safe and wholesome products. Thank you. 

[The prepared statement of Mr. Ray follows:] 

118 


49369.061
119 


49369.062
120 


49369.063
121 


49369.064
122 

Mr.STUPAK. Thank you. Mr. DeLorenzo. 

STATEMENT OF DAVID A. DELORENZO, PRESIDENT AND 

CHIEF EXECUTIVE OFFICER, DOLE FOOD COMPANY, INC. 

Mr.DELORENZO. Thank you, Mr. Chairman. Is that on? 

Mr.STUPAK. Yes, it is. It sounded good. 

Mr.DELORENZO. OK. Thank you again, Mr. Chairman and members of the subcommittee. 

My name is David DeLorenzo and I am the CEO of the Dole 

Food Company residing in Westlake Village, California. 

Our mission at Dole is to provide healthy, nutritious products to 

consumers. Food safety and consumer confidence in the safety of 

the food chain is not only vital to the mere existence of our firm, 

but we believe to the health of the Nation. We are pleased to participate in this hearing, and any other forums that might work toward ensuring food safety and with it the dietary habits of America. 

I would like to address the two vegetable recall events that 

touched our vegetable division during the past two years, and the 

steps that we and industry have taken to respond to those food 

safety incidents. First was the industry-wide halt of all spinach 

sales that occurred in September of 2006, after Natural Selection 

Foods recalled all packaged fresh spinach that it has produced and 

packaged. These packages were sold under 28 different brand 

names, one of which was ours. Our name was on the product, but 

it was produced and packaged by Natural Selection Foods, a highly 

regarded company that I believe has already testified before this 

subcommittee. Dole did perform regular audits of their operations 

and accepted the product into the Dole label and responsibility for 

their good practices. Dole has no ownership or other economic interest in Natural Selection Foods. Federal and state regulators reported that the source of the problem came from a specific spinach 

farm that was being farmed organically. At that time Dole did not 

internally farm or package spinach. We did not have the necessary 

specialized machinery to produce spinach and, therefore, had contracted with Natural Selections Foods to produce and package 

these products for us. Since that time we have invested in the machinery to package spinach and other tender leaf products ourselves, and are in the process of moving all of this activity under 

our own farming and into our own plants. 

The other incident I wish to address involved the recall of some 

of our salad product in Canada in September of 2007. On September 14 the Canadian Health Ministry told us that they had randomly pulled a number of bags of our salad from a store shelf in 

Canada, and that one had tested positive for E. coli. We immediately announced a recall. None of the other Canadian bags, nor 

any other bags of the same production batch that we had retained, 

nor any of the bags turned in by consumers tested positive for E. 

coli or any other pathogen. Our processing plant and the farms in 

which the produce was grown were carefully inspected by Canadian, U.S. federal and state regulators, and there is nothing negative to report there either. More significantly, there were no illnesses reported that were associated with this product in Canada 

123 

or the United States. The source of this incident, unfortunately, remains a mystery, which is disconcerting and I believe unacceptable. 

And I will second what was said earlier in testimony, and I 

would recommend later in my testimony the urgent need for more 

research about bacteria, E. coli 157. I’m sorry, 155. Despite the 

need for more research I do believe that the reaction to this spinach problem by the industry and Dole was swift and did show an 

unprecedented commitment to food safety. The leafy greens industry in California studied, prepared and adopted the Leafy Greens 

Marketing Agreement within four months of inception. The backbone of the program is mandatory testing and audits by California 

state inspectors using such food safety metrics as irrigation water 

tests, employee hygiene, harvesting equipment sanitation, buffer 

zones, soil amendments, wildlife intrusion and previous land use. 

We have taken a leading role in this statewide initiative and remain part of its ongoing board. We are now working with the Arizona industry to establish a similar agreement. Dole supports national regulatory food safety standards for all fresh produce items, 

and the California and Arizona programs could be the starting 

point toward designing and implementing these standards for both 

domestic and imported items. As a company Dole fresh vegetables 

has undertaken some key initiatives aimed at providing a higher 

level of food safety. First is our implementation of a trace back system that is RFID driven. RFID stands for radio frequency identification. This process involves placing a unique tag on every bin of 

lettuce harvested in the field. The tag is scanned using the global 

positioning system so that there is a tracking record of where in 

the field the product originated, how far and how long it traveled 

after that and how soon each bin was cooled and processed. RFID 

tracking is not a firewall for food safety. It does, however, provide 

real time field locations to within approximately 100 feet of where 

the product was harvested in the even trace back is needed. The 

inability to quickly trace back to a specific field location hampers 

the ability to determine the root cause of a problem, and has been 

a major impediment to regulatory investigators, not because our industry is unwilling, but because the technology available until now 

was not adequate as we mentioned earlier. 

In addition Dole and its growers have implemented testing for 

pathogens in the field prior to harvest, as well as testing at our 

produce centers, our processing plants and as it leaves a spinach 

product. Since the spinach incidences we have completed approximately 4,000 of these tests for pathogens. Thus far we have not 

had any positive tests for pathogens. 

Other Dole fresh vegetable risk reduction activities include a fulltime staff of quality assurance and food safety specialists. All of our 

fields in California are irrigated by water from deep wells or city 

water. We test the wells once a month during the growing seasons 

when the water is used. We will not grow, harvest or purchase 

crops from fields that get flooded with run off from other fields, let 

alone from cattle pastures, nor from fields that are too close to a 

place where cattle have been. We also contract with third party 

food safety companies to supplement our auditing processes in addition to the state inspectors that are part of the California Leafy 

Greens Agreement. All of our salad processing plants have full-time 

124 

quality assurance staffs on site, and all operate under a defined 

HACCP plan, and our fields operate under defined GAP or Good 

Agriculture Practices plan, as well as the leafy greens audit. 

The produce industry needs to continue to move forward with refining agricultural practices as science and technology advance. We 

need government support for more research activities in understanding how pathogens survive and migrate in the natural environment, especially E. coli. We also need research in developing microbial kill steps that will work on a perishable product. The 

amount of research needed is significant in both time and dollars. 

Dole supports standardized regulations in the food industry to ensure food safety. Food safety begins at the farm and continues 

through the supply chain to manufacturing plants, transportation, 

handlers, retail outlets and the hands and homes of the consumer. 

We encourage and support efforts to establish industry-wide protocols and procedures, as well as consumer education. Due to the perishability of fresh produce and the exactitude necessary for proper 

laboratory testing we would encourage all funding necessary for the 

state-of-the-art laboratories that can provide quick turn around of 

tests with exactitude of findings. 

Private companies such as Dole will continue to accelerate and 

champion new practices and technologies aimed at eliminating food 

safety risks. Produce is a living, breathing organism grown for the 

most part in the open air that requires specialized care. It will continue to take a concentrative and significant effort in time, funding 

and regulation from both the government and the private sector to 

make our food system, already the safest in the world, even safer. 

We commit ourselves to work with your subcommittee and help in 

any way possible with improving future food safety regulation. 

Thank you. 

[The prepared statement of Mr. DeLorenzo follows:] 

STATEMENT OF DAVID A. DELORENZO

Two E. coli recall events touched our Vegetables Division during the last two 

years: 

1. September 2006 industry-wide halt of all spinach sales, after Natural Selection 

Foods LLC recalled packaged fresh spinach it had produced and packaged. These 

packages were sold under 28 different brand names, one of which belonged to Dole. 

Dole has no ownership or other economic interest in Natural Selection Foods. The 

source of the problem appeared to be in a spinach farm field, owned by a reputable 

grower, that was being farmed organically. 

2. September 2007 recall of some of our salad product in Canada. Canadian 

Health Ministry told us that a bag of our salad randomly picked from a store shelf 

in Canada had tested positive for E. coli. None of the other Canadian bags, nor any 

other bags of the same production batch, nor any of the bags turned in by consumers, tested positive for E. coli. Our processing plant and the relevant farms were 

inspected by Canadian, US Federal and State regulators—no problems were found. 

More significantly, no illnesses were reported that were associated with this product 

in Canada or the United States. 

Responses to the 2006 spinach issue: The California Leafy Greens Marketing 

Agreement, covering 99% of California leafy greens handlers, was implemented. The 

backbone of this Agreement is mandatory testing and audits by California state inspectors using such food safety metrics as: irrigation water tests, employee hygiene, 

harvesting equipment sanitation, buffer zones, soil amendments, wildlife intrusion, 

and previous land use. Our Vegetables’ division President sits on the governing 

boards of both the California and the proposed Arizona programs. 

We view these industry programs as only a starting point. Dole supports national 

regulatory food safety standards for all fresh produce items. 

125 

Dole has made significant investments in developing and applying RFiD technology to leafy greens; we have made this program available to the all companies 

in the industry, without any payment whatsoever to Dole. RFiD tracking allows 

trace-back to within approximately 100 feet of where the produce was harvested. 

The inability to quickly trace back to a specific field location has been a major impediment to regulatory investigators, until now. 

We have implemented testing for pathogens in the field prior to harvest; we also 

test produce as it enters our processing plants and as it leaves as finished product. 

We have completed approximately 4,000 of these tests for pathogens. Thus far we 

have not had any positive test results for pathogens. 

We need government support for more research activities in understanding how 

these pathogens survive and migrate in the natural environment, as well as in developing microbial kill steps that will work on perishable produce. The amount of 

research needed is significant in both time and dollars. We believe that the federal 

agency best suited to oversee this research effort is the USDA. We also encourage 

more funding for state-of-the-art laboratories that can provide quick turn around of 

tests with exactitude of findings. 

STATEMENT

INTRODUCTION

Mr. Chairman and Members of the Subcommittee, my name is David DeLorenzo 

and I became the CEO of Dole Food Company, Inc. last June, having worked for 

Dole for the last 37 years. Thank you for allowing Dole the opportunity to be a part 

of the ongoing discussions on food safety. 

Our mission at Dole is to provide healthy, nutritious products to consumers. Food 

safety, and consumer confidence in the safety of the food chain, is not only vital to 

the mere existence of our firm, but, we believe, to the health of the Nation. We are 

pleased to participate in this hearing and in any other forums that might work toward ensuring the safety of the food chain and with it the improved dietary habits 

of our constituents. 

We take great pride in our people, the quality of our products and our commitment to Corporate Social Responsibility, including food safety, the environment, and 

the welfare of our workers. We also believe in transparency, and welcome any audits 

and scrutiny of our own operations and that of the industries in which we operate, 

to ensure that we and others in the industry are doing everything possible to deliver 

healthy, safe products to the consuming public. Toward that end, we would certainly 

welcome and encourage any Member of this Subcommittee and its staff to please 

come and visit any of our operations, to see our farms, refrigerated supply chain 

and manufacturing plants. Our salad manufacturing plants are in California, Arizona, Ohio and North Carolina, but we source from most of the fruit and vegetable 

growing areas in the United States, including California, Arizona, Oregon, Washington, Michigan, Texas, Colorado and Florida, to mention a few. Being this diverse 

requires us to establish strict and important relationships with farmers across a 

wide spectrum of crops who join us in adhering to good agricultural practices and 

strict protocols. 

We have been around as a company for more than 150 years, and we always are 

willing to exchange views and share our experience. The work this Subcommittee 

is doing is vital to our Nation, and to our industry, and we want to help in any 

way we can. 

Dole Fresh Vegetables is one of our divisions in North America; it is 

headquartered in Monterey, California. This is our division that has been affected 

by two E. coli recalls in the last two years. As I will discuss in a minute, in the 

first of these recalls, our name was on the product but it was produced and packaged for us by an unrelated, but highly-regarded company that has an excellent 

name in the production of spinach and tender leaf salads and in organic salads. In 

the more recent and much smaller recall, originating in Canada, one bag of our 

salad, pulled at random from a store shelf in Canada, tested positive, but no other 

bags tested positive in Canada or the U.S., our farms and processing plant were 

found to be totally clear and no one was reported sick or injured. Because these two 

recalls involved leafy greens, I will focus on our Vegetables business. Our Vegetables business is a provider of leafy greens, as well as other commodity vegetables 

to retailers and wholesalers in North America. The main products on a tonnage 

basis that make up the leafy greens category are spring mix, spinach, romaine lettuce, iceberg lettuce and cabbage. Our Vegetables business supplies these items 

both in a commodity form and in a prepackaged form. 

126 

Our Vegetables business on average ships over 5,000,000 servings each and every 

day of nutritious products in a prepackaged form. This number of servings almost 

doubles when you add in our commodity produce. 

When it comes to food safety, one illness is one too many. All of us at our company and in this industry have families that consume these products, and we understand first hand our responsibility to deliver products that are as safe and nutritious as possible. 

TWO RECALLS

The Subcommittee staff requested that I address the two vegetable E. coli recall 

events that touched our Company during the last two years. First was the industrywide halt of all spinach sales that occurred in September of 2006. On September 

15, 2006, Natural Selection Foods LLC recalled all packaged fresh spinach that Natural Selection Foods produced and packaged with Best-If-Used-By dates from August 17 through October 1, 2006, because of reports of illness due to E. coli O157:H7 

following consumption of packaged fresh spinach produced by Natural Selection 

Foods. These packages were sold under 28 different brand names, only one of which 

was owned by Dole. At that time, Natural Selection Foods was our sole supplier of 

spinach items, under a contract we had with them. On September 15, 2006, Dole 

announced that it supported the voluntary recall issued by Natural Selection Foods. 

Dole has no ownership or other economic interest in Natural Selection Foods. The 

U.S. Food and Drug Administration announced on September 29, 2006 that all spinach implicated in the outbreak had been traced back to Natural Selection Foods. 

The FDA stated that this determination was based on epidemiological and laboratory evidence obtained by multiple states and coordinated by the Centers for Disease Control and Prevention. 

From what the federal and California state regulators reported after the incident, 

it appears that there was no problem at Natural Selection Foods’ processing plant; 

instead the source of the problem was in one spinach farm field, owned by a reputable grower, that was being farmed organically. I understand that the Subcommittee received the testimony given last April by Charles Sweat, who is the 

President of Natural Selection Foods, so I will assume the Subcommittee needs no 

further detail on the Natural Selection recall from September 2006. At that time, 

we did not internally farm or package spinach. We did not have the necessary specialized machinery to produce spinach salad products and therefore had contracted 

with Natural Selection Foods to produce and package these products for us. Since 

that time, we have invested in the machinery to package spinach and other tender 

leaf products ourselves. 

The spinach recall galvanized an industry that already approached food safety as 

a top priority into becoming an industry with a heightened sense of urgency of the 

need to understand what steps we need to take to reduce this risk even further in 

the future. Some of this effort has involved strengthened good agricultural practices 

and some has involved more testing of produce in the field, at the processing plant 

door and of finished product. We recognize that we are an industry that still needs 

to do more, and we strongly believe that government has an important role to play, 

particularly in supporting needed scientific research on the causes of outbreaks and 

in developing nationwide food safety regulation, which I will discuss further in a 

moment. 

The other incident I wanted to talk about involved a recall of some of our salad 

product in Canada in September of 2007. On September 14, 2007, the Canadian 

Health Ministry told us that they had randomly pulled a number of bags of our 

salad from a store shelf in Canada, and that one had tested positive for E. coli. We 

immediately announced a recall of the affected lot code. We expanded the Canadian 

recall to parts of the United States since some of the same raw materials were used 

in product sold in those parts of the U.S. and Canada. None of the other Canadian 

bags, nor any other bags of the same production batch that we still had, nor any 

of the bags turned in by consumers, tested positive for E. coli or any other pathogen. 

Our processing plant and the farms on which the produce was grown were carefully 

inspected by regulators—and there was nothing there, either. More significantly, 

there were no illnesses reported that were associated with the product in Canada 

or the United States. 

MOVING FORWARD—EFFORTS UNDERTAKEN AND NEEDED RESEARCH AND

REGULATION

The fact our industry has had recalls should not be viewed as an indication of 

complacency. Research is the key to understanding the following scientific questions 

that need to be answered: where does this E.coli O157:H7 microorganism survive 

127 

in the natural environment, other than inside cattle, which is the primary host organism; how does E.coli O157:H7 survive in the natural environment; how is E.coli 

O157:H7 transferred from one location to another; and how do we kill or otherwise 

eradicate it, without destroying a highly perishable product? From a government 

support viewpoint, we believe there is severe under-funding in the area of applied 

research and science-based mitigation strategies. At times we are forced as an industry to react to anecdotal, or bench-top tests which cannot be replicated in real 

world field conditions. 

You may ask: why is this so difficult a scientific problem to solve? The answer 

lies in how extremely rare it is to find the virulent E.coli O157:H7 on crops. For 

example, since the September 2006 spinach event, we instituted raw crop testing 

in the fields before harvesting, as well as testing of raw crops as they enter our 

processing plants and testing of finished product. Since September 2006, we have 

run approximately 4,000 of these tests to date, using state-of-the-art tests, and we 

have not yet had a single positive test for E.coli O157:H7. 

We strongly feel that research is where the lion’s share of any extra resources allocated by Congress should go. Please note that we don’t have any objection to 

spending more federal dollars on inspections and audits. Adding more inspectors to 

regulatory agencies or giving them mandatory recall authority is a good thing. However, having more inspectors will not get to the root cause of how pathogens like 

E.coli O157:H7 survive and transfer from one location to another, and it will not 

address the science needed to develop a true kill step or other prevention. It’s the 

old question of where you can get the most bang for the buck. We’d recommend that 

Congress put most of that extra money into well thought-out research. This Subcommittee can play an invaluable role in taking testimony from public/private panels of the best scientific minds to figure out what specific research should be funded, 

and in what priority order. We at Dole would be happy to share our best thoughts 

on this topic, too. 

I want to highlight for the Subcommittee some of the additional steps that have 

been taken since September of 2006, in both our company, and in the industry as 

a whole. The leafy greens industry in California has adopted the Leafy Greens Marketing Agreement (for purposes of this hearing this is referred to as the CA–LGMA). 

The CA–LGMA is an unprecedented commitment to food safety. Although it is in 

theory voluntary, the backbone of the program is California state inspectors in the 

fields of CA–LGMA signatories, auditing against a set of food safety metrics established by some of the sharpest scientific minds from industry, academia, and the 

public sector. For example, some of the specific areas the California state inspectors 

audit against include irrigation water tests, employee hygiene, harvesting equipment sanitation, buffer zones, soil amendments, wildlife intrusion, and previous 

land use. We take pride that, not only was our Vegetables business one of the companies instrumental in driving this state-wide initiative, but our Division President 

is currently the Vice-Chairman of the CA–LGMA Board. Arizona has a similar 

LGMA program under development which is almost identical to the California program. Our Vegetables’ division President also sits on the Arizona governing board, 

which is tasked with developing and implementing a complete audit program. 

Some would criticize this program as voluntary, but please understand that the 

only thing voluntary about it is whether to join or not. Once you’re in, compliance 

and government inspection are mandatory. Ninety nine percent (99%) of the leafy 

greens handlers in California have signed onto the program—and some got encouraged into ‘‘volunteering’’ by big customers who would not buy their products unless 

they ‘‘volunteered.’’ So compliance and inspection are, for all intents and purposes, 

mandatory for the whole industry in California. The CA–LGMA program, including 

state inspectors, is funded by assessments paid by signatory members. 

Some would argue that federal or state regulations would have been the proper 

avenue, instead of the CA–LGMA program. If time had not been of the essence, that 

route might well have made sense. The industry felt, however, that it couldn’t wait 

for government to act. As a testament to our industry commitment to food safety, 

private industry developed this field audit program, from absolutely nothing to having California state inspectors in our fields performing audits, in less than four 

months. 

The fact that our industry did not have the luxury of waiting for government to 

act does not mean that we think the job is finished or that there is no role for government now. On the contrary, Dole supports national food safety standards for 

leafy greens, and the California and Arizona programs should be the starting point 

toward designing and implementing these standards. In the past, leafy greens food 

safety was considered a West Coast problem. However, as fuel costs continue to escalate, more Midwest and East Coast states, and Canada, are learning how to grow 

leafy greens in climates outside of California and Arizona. 

128 

I also would like to bring to your attention another important industry initiative— 

the Center for Produce Safety, headquartered at the University of California, Davis. 

Trade groups, private companies, the University of California, and the California 

Department of Food and Agriculture, have funded the launch of this Center through 

grants. This Center is intended to be the clearing house for available produce food 

safety research, and to fund new scientific studies focused on strategies to mitigate 

risks. As discussed above, we very strongly believe that the federal government 

should play a key role in the research efforts. 

As a company, Dole Fresh Vegetables has under taken some key initiatives aimed 

at providing a higher level of food safety. First is our implementation of a trace back 

system that is RFid driven. RFiD stands for Radio-Frequency-Identification. The 

process involves placing a unique tag on every bin of lettuce harvested in the field. 

Once a bin is filled, the tag is scanned using the global positioning system and attached so that there is a tracking record of where in the field a product originated 

and where it traveled after harvest. RFiD tracking is not a fire wall for food safety. 

It does, however, provide real time field locations to within approximately 100 feet 

of where the product was harvested in the event trace back is needed. The inability 

to quickly trace back to a specific field location hampers the ability to determine 

the root cause of a problem and has been a major impediment to regulatory investigators, not because our industry is unwilling, but because the technology available 

until now was not adequate. 

Although Dole has made significant investments in developing and applying the 

RFiD technology to leafy greens, we have made this program available to anyone 

in the industry who wishes to use it, without any payment whatsoever to Dole. We 

believe that the members of our industry should compete with each other on quality 

and service, not on food safety. 

As I mentioned a few moments ago, a second initiative we implemented is testing 

for pathogens in the field prior to harvest. Similar to the HACCP (Hazard Analysis 

of Critical Control Points) principles developed for NASA, we believe that testing 

needs to be a part of an overall risk reduction strategy and that prevention before 

the product leaves the field is a critical and proactive step. We are also testing 

produce as it enters our processing plants and as it leaves as finished product. To 

date we have completed approximately 4,000 of these tests for pathogens. As noted, 

thus far we have not had any positive test results for pathogens—at times it seems 

like we are looking for the proverbial ‘‘needle in a haystack.’’ With research help 

from government, a lot more testing should be done, by many more companies, and 

when the pathogens are found in this broader effort, science will have the data on 

the basis of which we can eradicate this problem. 

Other Dole Fresh Vegetables risk reduction activities include a full time staff of 

quality assurance and food safety specialists. Their primary function as it relates 

to food safety is to develop and implement science-based risk reduction strategies, 

as well as seek out and evaluate best practices within our industry as well as other 

food industries. 

All of Dole’s fields in California are irrigated by water from deep wells or city 

water. We test the wells once a month during the growing season, when the water 

is used. We will not grow, harvest or purchase crops from fields that gets flooded 

with runoff from other fields, let alone from cattle pastures, nor from fields that are 

too close to a place where cattle have been. 

In addition, we contract with third-party food safety companies to supplement our 

auditing process, in addition to the state inspectors that are part of the California 

leafy greens agreement. One third-party company provides us with independent 

oversight to our field operations, and another is used to provide independent oversight to our salad processing plants. All of our salad processing plants have full time 

quality assurance staffs on site anytime the plant is operating. All of our plants operate under a defined HACCP plan, and our fields operate under a defined, formal 

GAP (Good Agricultural Practices) plan, as well as the CA–LGMA audit program. 

We are also working with outside vendors in developing even more reliable pathogen testing kits. Because of the amount of naturally occurring beneficial bacteria 

that is found on all produce, rapid test kits to detect pathogens that were developed 

in other industries, such as the meat or poultry industries, tend to give a high rate 

of false positives on lettuce. 

CONCLUSION

The produce industry needs to continue to move forward with refining agricultural 

practices as science and technology advance. We need government support for more 

research activities in understanding how pathogens survive and migrate in the natural environment. We also need research in developing microbial kill steps that will 

129 

work on a perishable product. The amount of research needed is significant in both 

time and dollars. The first agenda item for any research program is to determine 

the right questions to ask. We believe that the federal agency best suited to address 

the important issues related to leafy greens is the USDA. The USDA already has 

a research station set up in Salinas, California, which is in the heart of the industry, and has extensive experience with various leafy greens products. USDA also has 

conducted some limited applied research on pathogens, but they have been limited 

in scope by funding. 

A group of over seventy technical experts from academia, government regulatory 

and research, and the private sector, met in Washington, D.C., at a research symposium co-sponsored by Dole, this past September, focusing on understanding how 

pathogens survive and migrate in the natural environment. Everyone present 

agreed that there is a daunting task ahead of us, and we just do not yet have 

enough science-based answers to some very practical questions. But we have to start 

somewhere, and we have to remain committed to the research. 

We respectfully ask this Subcommittee, and, more generally, the Energy and 

Commerce Committee, to do whatever it can within its power to influence significant funding of pathogen research for produce. Private companies such as Dole will 

continue to accelerate and champion, as fast as possible, new practices and technologies aimed at eliminating food safety risks. Produce is a living, breathing tissue 

that does not hold up to most conventional food safety practices that work in other 

industries. We cannot inspect our way out of food safety problems any more than 

we can test our way out of it. It will continue to take a concerted and significant 

effort in time and funding and regulation from both the government and private sector, to make our food system—already the safest in the world—even safer. We 

heartily agree with this Subcommittee that we—all of us—can, in good conscience, 

do no less. 

Mr.STUPAK. Thank you. Mr. Eisenberg, please. 

STATEMENT OF DAVID A. EISENBERG, CHAIRMAN, ANRESCO 

LABORATORIES 

Mr.EISENBERG. Thank you for inviting my testimony. 

My name is David Eisenberg. I am chairman of ANRESCO Laboratories, founded in 1943. I have been with the company 34 years. 

While ANRESCO was a USDA accredited meat laboratory for 30 

years, from 1976 to 2006, we surrendered our accreditations this 

past year because we were rarely analyzing regulatory samples, 

and most of all because the USDA dramatically increased the cost 

for accreditation. 

The regulatory work we perform today relates to FDA regulated 

imports, and it is to this role I speak today. ANRESCO has performed sampling and analytical work for importers to meet FDA 

requirements since 1981. Such work represents 40 percent of our 

business. We run almost every analysis the FDA runs routinely. 

Private laboratories in total employ possibly 50 people nationwide 

to service this very small specialized market. ANRESCO’s sampling 

and analytical work is equivalent to that performed by the FDA’s 

own laboratories. The FDA regulates the food in regulated imports 

by reviewing import entries, releasing imports it considers low risk, 

and sampling and analyzing at its own laboratories, imports it believes may be unsafe or otherwise violate U.S. food standards. This 

work is performed under its Surveillance Program. 

When the FDA finds an imported product violates its standards 

it may place the product on Detention Without Physical Examination, DWPE, where the FDA considers the products violative until 

the importer proves it meets FDA standards. The importer does so 

by retaining a private laboratory such as ANRESCO to sample and 

analyze the product and to submit such results to the FDA. Only 

130 

a very small proportion of FDA regulated imports are subject to 

DWPE. 

With this as background I am pleased to offer suggestions to improve the FDA’s regulation of imports. Relating to its Surveillance 

Program the FDA should provide an organized forum where industry can provide advice into what imports the FDA selects for sampling. The import industry could have possibly advised the FDA 

that melamine was being added to wheat gluten meal in China. 

The FDA should reallocate its import staff so enforcement of its 

regulations is uniform among its 15 districts. For years the FDA 

has been understaffed in New York and in Los Angeles and 

overstaffed at smaller ports. This leads to port shopping. The FDA 

should allow importers to use private laboratories that it accredits 

to sample and analyze samples under its surveillance program. 

This could significantly increase the number of shipments analyzed. The FDA should eliminate its current line by line review of 

private laboratory submissions that waste extensive FDA staff 

time. The FDA must have the legal authority to audit the accredited laboratories whenever it wants to and for whatever reason it 

believes necessary. The incentive for importers to use private laboratories for surveillance sampling and analysis is that such laboratories will perform the work more quickly than the FDA does 

itself. Shipments can then be released into commerce more quickly, 

critical to importers. Private laboratories would be willing to pay 

a fee to FDA for FDA accreditation as this will provide them additional work. ISO 17025 accreditation is not an adequate basis for 

assuring private laboratories are competent to perform work to 

FDA standards. The FDA must itself accredit private laboratories 

and only then will it have confidence in their work and then rely 

on it. 

Relating to the DWPE Program, while this program is excellent 

in concept and works well in practice for most imports, it is greatly 

weakened by inadequate FDA implementation. The FDA’s Southwest Import District in Dallas has procedures that assure the honesty of the DWPE Program. These procedures should be adopted 

nationwide immediately. They include a requirement that DWPE 

shipments are sampled by the private laboratory. The New York 

district still allows importers to take their own samples. This is 

akin to the wolf guarding the sheep. The importer must advise the 

FDA in advance what private laboratory they intend to use for a 

given import. In the other districts when ANRESCO finds a violative import the importer usually advises us not to submit the result 

to the FDA. The importer may then find another private laboratory 

to take new samples to reanalyze the product to get the shipment 

released. 

In June of 2006 Dr. Robert Brackett, then director of FDA’s 

CFSAN, at the Institute of Food Technologists meeting at Orlando, 

Florida advised the FDA did not consider pesticide residues in 

foods a serious matter and it would no longer monitor them. This 

sent a message to the produce industry that it was not important 

to comply with EPA, FDA regulations. If the FDA considers its regulations governing pesticide residues in foods unnecessary it should 

request Congress to change the law, not ignore its responsibility to 

enforce it. 

131 

Twice during 2005 I met with senior FDA staff to complain the 

FDA was not enforcing its pesticide residue requirements on snow 

peas imported from Guatemala. I presented data for 25 samples 

ANRESCO had taken at retail and had analyzed finding 13 violative. I pleaded for FDA to take more surveillance samples. Instead 

the FDA reduced the number of surveillance samples it took. I was 

flabbergasted when I saw President George Bush on television 

talking from a Guatemalan farm last year praising that industry 

for developing an export business for produce when his appointees 

knew a high percentage of the product violated FDA standards, 

and they had facilitated its importation. 

Other suggestions, the FDA should allow the electronic submission of all private laboratory reports relating to food imports, especially perishables. It is critical that the import process be as quick 

as possible to assure compliance with it. The FDA should not allow 

importers to place their products in commerce before having a release, as has been the case in south Florida. Thank you. 

[The prepared statement of Mr. Eisenberg follows:] 

132 


49369.065
133 


49369.066
134 


49369.067
135 


49369.068
136 


49369.069
137 


49369.070
138 


49369.071
139 


49369.072
140 


49369.073
141 

Mr.STUPAK. Thank you, Mr. Eisenberg. 

Dr. Brackett, your testimony, please. 

STATEMENT OF ROBERT E. BRACKETT, PHD, SENIOR VICE 

PRESIDENT AND CHIEF SCIENCE AND REGULATORY AFFAIRS OFFICER, GROCERY MANUFACTURERS ASSOCIATION 

Dr.BRACKETT. Thank you, Mr. Chairman. 

Good afternoon to the rest of the committee. 

I am Robert Brackett, Senior Vice President and Chief Science 

and Regulatory Affairs Officer at Grocery Manufacturers Association. 

Food companies recognize our responsibility to ensure that the 

food we provide to consumers is safe. To address the challenges 

posed by rising imports and changing consumer preferences we 

constantly identify under duress potential sources of contamination 

throughout each product’s life cycle. We have made significant new 

investments in food safety, identifying and adapting a range of 

practices in programs to reduce the risk of contamination. Food 

safety is our top priority. 

Ultimately, the burden of providing safe food falls on our industry, but this responsibility is shared by federal, state and local 

agencies. By setting and enforcing tough food safety standards 

agencies like FDA and USDA’s food safety inspection service help 

the food industry to ensure that the safety of our food supply is as 

safe as it can be. 

Providing these agencies with adequate resources is critical to 

their ability to help the food industry ensure the safety of our food. 

As director of FDA’s Center for Food Safety and Applied Nutrition 

between 2004 and 2007 I routinely stated to the agency the critical 

need for more resources. In my view, FDA’s food safety and food 

related programs were willfully inadequate and I shared that view 

with the agency. But despite my best efforts funding for FDA food 

related programs barely kept pace with inflation. As a result more 

than 800 scientists, inspectors, and other critical staff have been 

lost in the last four years, including some of FDA’s most experienced experts. Recent nationwide recalls remind us how devastating food borne illness can be and how critical it is for FDA to 

respond quickly to safety problems. It is important to maintain this 

level of response, but there is a need—but there needs to be an increased focus on prevention and intervention to stop these outbreaks from happening in the first place. The adoption of preventative controls to prevent contamination, the use of modern testing 

strategies to detect pathogens before the product is released and 

application of innovative new processing technologies to destroy 

pathogens all have a role in improving the safety of our foods. 

While at CFSAN we recommended a variety of options to address 

the safety of foods, including the proposal to improve produce safety that could include a requirement for tough, but enforceable 

produce safety standards. A position that is not only shared by, but 

has actually been requested by, the food industry and many farm 

organizations. The overall goals of the plan were to prevent contamination, minimize public health impact in the event that contaminated product did get into the marketplace, to enhance the capability to provide safe products, and also to improve communicaVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00147 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
142 

tions to both domestic as well as foreign suppliers. And also facilitating and supporting the science that should always be the underpinning of any food safety effort. 

Interestingly, these recommendations contained elements that 

specifically addressed actions that were recommended later in the 

same year in GMA’s four pillars document, as well as FDA’s Food 

Protection Plan. Unfortunately, the Administration did not seek 

funds for the plan and Congress failed to provide adequate funding 

as well. Consequently, the industry decided to act on its own 

through promoting their and statewide regulations and marketing 

orders. 

In addition to requiring tough, but enforceable produce standards, Congress should also require FDA to complete their proposed 

modernization of good manufacturing practice standards, or GMPs, 

and require food importers to document the food safety efforts of 

their foreign suppliers. In the highly unlikely situation that a company refused to voluntarily recall a product that poses a severe 

health consequence, FDA should be given the power to order a recall. FDA could also do much more to rebuild FDA’s scientific and 

information technology capacity, and could do more to build capacity of foreign governments to ensure the safety of our imported 

foods. 

The food industry supports giving FDA new responsibilities that 

would help ensure the safety of our food, but new responsibilities 

without new resources will not improve the safety of our food supplies. In fact, new responsibilities without requisite resources to 

carry out those responsibilities has just the opposite affect. It dilutes out existing efforts in safety and makes FDA less able to address the real food safety issues. Likewise, new restrictions on 

ports of entry, new penalties or any new labeling requirements will 

also not result in a safer food supply for the American people. By 

focusing our efforts on prevention, by increasing FDA resources 

and by leveraging the expertise in resources of the food industry 

itself Congress can help us meet the challenges posed by rising imports and changing consumer preferences. 

Thank you. I will be happy to answer any questions. 

[The prepared statement of Mr. Brackett follows:] 

143 


49369.074
144 


49369.075
145 


49369.076
146 


49369.077
147 


49369.078
148 


49369.079
149 

Mr.STUPAK. Thank you, and thank you to everyone on this panel. 

We are expecting votes. We are going to get going and see how 

many we can through here before we have to run off for our votes. 

We are going to go five minutes and we will probably go a second 

or third round if necessary. 

Mr. Shoemaker, we got Mr. Rodkin there. I am a little confused 

on what happens, especially on the pot pies, because tests performed by ConAgra or Banquet showed that all the meat pies were 

prepared with the same equipment. Since the turkey pot pies contained salmonella where else could the bacteria have come from 

but the turkey? I’m sorry. Yeah, go ahead. 

Mr.SHOEMAKER. I can only address what has happened within 

the Butterball facilities, the four walls there. I have no knowledge 

of ConAgra’s facilities. But within our four walls we met the kill 

step, we met the low bacterial level and then also all tests within 

that facility have proven that it was negative for salmonella. 

Mr.STUPAK. OK. 

Mr.SHOEMAKER. Also the salmonella strain that was found was 

a strain that has been found in chickens in all but one incident—— 

Mr.STUPAK. But not in the pot pies? 

Mr.SHOEMAKER. And in turkey only once, and that was not within our system. 

Mr.STUPAK. Right. But there was the vote. Son of a gun. OK. Let 

me ask you this. You said you monitor and control temperature. 

Why don’t you test for salmonella and other bacteria right after the 

product is cooked instead of waiting until it is chilled? 

Mr.SHOEMAKER. Whenever you look at a cook in the bag product, 

a low risk product, we have specifications from all of our customers 

how you want to check it. What are the specifications, whether it 

is a size, whether it is the regime on checking the product, there 

was not a test to check because it being a low risk and had gone 

through the kill step and—— 

Mr.STUPAK. So if your customer would ask you to—— 

Mr.SHOEMAKER. In other words—— 

Mr.STUPAK [continuing]. Check right after the cooking, you 

would do it then before you chilled it? 

Mr.SHOEMAKER. Yes, we would. We would do whatever our customer asked. 

Mr.STUPAK. OK. Does that make sense, Mr. Rodkin, then? Let us 

say on turkeys to test for salmonella after it is cooked, before it is 

cooled? 

Mr.RODKIN. I am not an expert—— 

Mr.STUPAK. OK. 

Mr.RODKIN [continuing]. On that, but I believe that is one of the 

steps that we have implemented subsequently. I also will agree 

with Mr. Shoemaker that they cooperated fully and we never were 

able to say exactly, precisely that it was an issue with the Butterball turkey. So I want to agree with that, but I can also—yes? 

Mr.STUPAK. Where does it come from then? 

Mr.RODKIN. Yes. 

Mr.STUPAK. I mean I guess that is—— 

Mr.RODKIN. Yes. 

Mr.STUPAK. And being a consumer and not a scientist I guess I 

am asking the same question. 

150 

Mr.RODKIN. Sure. 

Mr.STUPAK. You are telling me it is not you. You are telling me 

it is not you. Where does it come from? 

Mr.RODKIN. Well, on the first day that we became aware of the 

issue we knew very little about the source, but we did know as Mr. 

Shoemaker has said that any possible salmonella would be killed 

through proper cooking, because salmonella can’t survive past—beyond 165 degrees. 

Mr.STUPAK. Right. 

Mr.RODKIN. So consumers are not at fault. They should expect 

safe product. This generated an intensive analysis of our cooking 

directions and microwave performance. But also because it was our 

absolute responsibility to find the root cause in the product we took 

over 3,000 samples of product we had from finished pot pies and 

were able to isolate salmonella in just 17. Those all happened to 

be Banquet turkey pot pies from two dates in July of 2007. But despite very intensive investigations and analysis and cooperation we 

were not able to determine the exact, precise source of the contamination. It was not absolutely proven and, therefore, we had our 

people take the broadest possible approach and assume that all 

possible sources were or could be the source. And as a result we 

have made some extremely—— 

Mr.STUPAK. Well, let me ask you this. If it is not the packaging, 

if it is not the turkey, if it is not the machine, could it come from 

the gravy? Is the gravy made from a separate firm that comes into 

your pot pies? 

Mr.RODKIN. We have checked every last ingredient and have 

found no source of salmonella. And, therefore, because we care very 

deeply about making the safest food possible. We took a number of 

steps across the board in that facility to make sure that all raw 

materials now have tighter specifications—— 

Mr.STUPAK. Sure. Let me put my consumer hat back on. 

Mr.RODKIN. Yes. 

Mr.STUPAK. So if you have tested everything and Butterball says 

not our fault, but yet we have salmonella, then how can Americans 

be sure that the next pot pie they buy won’t have salmonella in it? 

If it is not the gravy, it is not the packaging, it is not the turkey, 

it is not the cooking, it is not the microwave, it is not nothing. How 

do we know then? 

Mr.RODKIN. Again, having made all of these changes—— 

Mr.STUPAK. Right. 

Mr.RODKIN [continuing]. That I was describing and in working in 

conjunction with the USDA I did mention that in the slightest possible chance that any salmonella could come through the process it 

would be killed with proper cooking. And, therefore, we took a very 

intensive look at our instructions and at microwaves. 

Mr.STUPAK. Right. 

Mr.RODKIN. And found much greater variability than we had historically in microwaves and, therefore—this was our old package. 

Sorry it is so small. I hope you can see that. But importantly on 

the back are where the instructions are. We have made changes before we reintroduced the product into the marketplace. Took off 

where it says ready in four minutes in a microwave. 

Mr.STUPAK. Right. 

151 

Mr.RODKIN. Said microwaveable, but must be cooked thoroughly. 

See back for directions. And now the directions have been 

changed—— 

Mr.STUPAK. So the answer is to cook it longer for the consumer 

then, in other words? 

Mr.RODKIN. That is what—— 

Mr.STUPAK. I guess I am trying to—my time is up and they are 

calling us for votes. Let me ask you one more. On the Peter Pan 

peanut butter for salmonella, again, ConAgra didn’t find it, but the 

FDA did. What changes were made in Peter Pan then? I mean I 

think Peter Pan you have the salmonella and said it was a leaky 

roof. That was repaired and we still found it after that, after a new 

batch, so—— 

Mr.RODKIN. That is a question I need clarification on, because we 

have not found any salmonella subsequently. 

Ms.DEGETTE. If the gentlemen will yield. It was the FDA that 

found the salmonella. 

Mr.RODKIN. Right. 

Ms.DEGETTE. Not you. 

Mr.STUPAK. After—— 

Mr.RODKIN. And I need some clarification on that, because with 

this we are unaware of that. 

Mr.STUPAK. OK. 

Mr.RODKIN. We are unaware of that because we closed the facility down immediately and only reopened last August. And it is an 

extremely different facility, totally redone, totally remade. And, 

again, it is because we are extremely concerned about, as Mr. 

Marler said, food safety risk is a bad business decision. 

Mr.STUPAK. OK. Our votes are up. We got three votes on. I think 

now is probably appropriate time, Mr. Dingell, unless you want to 

go. All right. Let us—yeah. Well, we are going to adjourn for—until 

12:50, one o’clock? 

Mr.DINGELL. Yeah. 

Mr.STUPAK. One o’clock, two o’clock? How about 1:50? 1:50. That 

will give us 40 minutes and we are going to have votes. And the 

first one is just up that usually extends more than 15 minutes, so 

I think with three votes we better give it 40 minutes. We will recess until then. We will be back at 1:50. Thank you. 

[Recess.] 

Mr.STUPAK. The Committee will come back to order. Oh, mics are 

much better. Thanks. 

Mr. Shimkus, for questions, please. 

Mr.SHIMKUS. Thank you, Mr. Chairman. 

I want to thank the panelists for being here. I had to make sure 

I got my own processed food while I am going back and forth to 

vote. It is a glamorous lifestyle we have here, and this is our lunch. 

So a couple things. First of all, especially with the CEO’s who are 

present. Can you maximize shareholder wealth by producing unsafe foods and having recalls? Yeah? 

Mr.RODKIN. First, if I might. I would just like to clarify when before we left for lunch there was a question on peanut butter. And 

I wanted to clarify to let you know that the product that was discussed that FDA found salmonella was recalled product. That was 

product that they found in our plant that we had already recalled. 

152 

The plant had been shut down for six months, so this was not product out in the marketplace. It is the reason that we did the recall, 

and it is the reason that we had such a major renovation, total remake of our facility. We did not just fix the roof. It was a total facility. All the equipment, all the testing procedures, additional personnel. I can tell you it is many, many millions of dollars and it 

is now the state-of-the-art facility from a peanut butter manufacturing standpoint. So I wanted to just make sure I clarified that. 

Onto your question. Taking any kind of food safety risk is a really bad business decision as Mr. Marler talked about. There is nothing worse than thinking that one of your products could cause 

someone harm. It does damage to your brands, consumer perception, and that is our most valuable asset on our books. It harms 

relations with your customers. By that I mean our retailers, because you have to remove product from their shelves. And it is a 

big, big financial burden I can tell you from a peanut butter standpoint, and the corrections that I just talked about and all the costs 

of that recall are many multiple years of the brand’s profit. 

Mr.SHIMKUS. And I am sure that will really kind of be a similar 

answer as far as, you know, name ID, a product line, safety of food, 

and your reliable customers. I mean it really does take a dive when 

things like this happen. I mean so everyone agrees with that. I 

mean it is not a marketing ploy to want to do this. In fact, it is 

damaging across the board. And I think it is also important that 

we understand raising a capital formation for the risks involved, 

the return on the investment and all those challenges that operate. 

Of all, we were talking about some on the walk over to the votes. 

I mean we do have lapses, and that is kind of what we are trying 

to—the folks who are on now, because we do have a safe food supply. We are consuming a multitude of pounds of food in this country by the second, and but we do have lapses. 

When we talk about a recall, a voluntary recall, from the amount 

of the lot and the batch, whatever you all decide to finally—it is 

voluntary so you are going to recall a product that has been produced from one of your factories. That occurs after the fact that the 

product has been on the shelf. Someone has purchased it, and there 

has been in essence an adverse reaction. So if you take the lot, the 

100 percent of the product line, from whatever window you decide 

the recall needs to occur, how much—what percentage actually returns? How much? What percentage actually consumed and gone? 

So when—if you were to receive everything back. Say you say, OK, 

let us do a voluntary recall of peanut butter, and it is going to be 

this lot of whatever. What percentage actually would come back? 

And in this case you were given the answer to the question of the 

Chairman of the reinspected of the lots that had returned. But how 

much? What is it, 10 percent of a product line that once you recall 

after it has been out in the consumer sector and some of it had 

been consumed, some of them purchased and probably in some— 

on some shelf somewhere? What is the percentage? Why don’t we 

just go to the top four food processors here. 

Mr.RODKIN. I can’t give you an exact percentage. I can tell you 

it is significant. And, I guess, the most—— 

Mr.SHIMKUS. What is that, 50—what is it? I mean—— 

153 

Mr.RODKIN. Well, I think the most important thing is in the case 

of our two recalls, we recalled total production, everything, 100 percent. And that meant destroying all of our own inventory, taking 

all the product, 100 percent of the product, off the retailer’s 

shelves. 

Mr.SHIMKUS. But a lot of that had been consumed and purchased 

in the food chain, correct? 

Mr.RODKIN. It is possible that some of it could have. I mean—— 

Mr.SHIMKUS. I am a big peanut butter eater. 

Mr.RODKIN. Yes. 

Mr.SHIMKUS. All right. So we go through peanut butter pretty 

quick in our household. So a lot of that, if it is—my question is— 

and I don’t want to be simplistic. But, yeah, how much product, if 

you are just doing a basic percentage of any type of product, how 

much is actually returned to you all in a recall? 

Mr.RODKIN. Yeah. In the case of peanut butter it was very significant. I don’t know exactly what the numbers were. I can—— 

Mr.SHIMKUS. As significant at 30 percent? 

Mr.RODKIN. Yes. 

Mr.SHIMKUS. Twenty-five percent? 

Mr.RODKIN. Yes, at least that. 

Mr.SHIMKUS. At least. Is that normal? Why don’t we—Mr. Shoemaker? 

Mr.SHOEMAKER. I think that when you are talking about this I 

think there is different types of premises you have got to go by. We 

have never had a recall at Butterball, but we do mock recalls. And 

within our mock recall it goes back to do you know where your 

product’s coming from? We have the ability by daily lots on some 

products to break where the lots are. And on some of the products, 

depending on their risk level, might be test and hold. So 100 percent of that product might be in our own facility, but it just depends on your category of risk as to what our percentage of products would be that we would capture back. 

Mr.SHIMKUS. Mr. Lischewski? 

Mr.LISCHEWSKI. We have a—our example is a bit more specific. 

When we did the Castleberry’s recall we recalled over two years 

worth of product until we isolated the problem. When we isolated 

it down to two product codes, to this date we have been able to pull 

back approximately 74 percent of the product under our control. 

Now, on top of that we allowed retailers, rather than return it to 

us, to destroy product at their location. And consumers were allowed to destroy product at home and just send in for a refund regardless of whether it was one of the actual product codes involved, 

or any of our other products. So 74 percent of ours are able to track 

absolutely. The other 26 percent, again, we are not sure how much 

of that would have been destroyed by retailers, consumers, or it 

would have been consumed. 

Mr.SHIMKUS. Mr. Ray? 

Mr.RAY. Congressmen, our situation, our recalls required our— 

recommended that consumers destroy the product and not return 

it. And so we had a very low percentage of product returned. 

Mr.SHIMKUS. How do we know that the consumers comply? I 

mean the reality is you have—the postal service clerks can— 

154 

canned foods for food shelters and stuff. How—we just don’t know 

do we? 

Mr.RAY. No. 

Mr.SHIMKUS. I mean we all hope that they do. We are hoping 

that they, first of all, know about it. Even though our best efforts, 

we don’t—our best effort is to educate the consumers that they 

have trouble. But then we don’t, we really don’t know where, especially when you are asking the consumer to destroy it. 

Mr.RAY. In our particular situation most of our products that 

have been affected have been food service products, so we have 

been able to go to the distributor. The distributor then can go to 

their consumer. And I think it can get good withdrawal in that scenario. 

Mr.SHIMKUS. Let me finish. And Mr. DeLorenzo, I’m sorry. I 

didn’t want to leave you out there. Yeah, the camera is blocking 

mine. 

Mr.DELORENZO. Yes. On the—we have perishable products for 

the most part that we are talking about here, and so we even have 

a—percent actually returned, but—— 

Mr.SHIMKUS. Can you check and see if there should a button or 

two? 

Mr.DELORENZO. There is a green light. I thought it was on. So 

the bags that were actually returned are few. How much is destroyed as we say? I will say though, Congressmen, that from what 

I could see from this last recall there was very, very good coverage 

in the media. The radio—I think it must be by law that every radio 

station, every television station. So I think at least from that perspective there was very, very good coverage. But in terms of what 

is actually returned it is a small amount. 

Mr.SHIMKUS. The—and finally, all these cases are different. They 

have, you know, different criteria. It is great for the panel to understand the enormity of the problem, but it is very difficult to, you 

know, get into each little—I am not going to get into each little 

manufacturing problem or stuff, so I would like to end this. Obviously there we have had problems, and we would like to get to zero 

defects. We know we don’t live in a perfect world, but everybody 

wants this, and it is good for you, it is good for your shareholders, 

it is good for the safety of our constituents. How many of these— 

and I also, from a military background having watched the Army 

IG and inspector general come down and say I am from, you know, 

the IG. I am here to help you. Usually that is not always a good 

sign. And though I think they are intended to be helpful, sometimes we feel them as not being as helpful as they can be. So what, 

in your estimation, is the aspect of some of these problems either 

in good manufacturing practices or the lack thereof? Lack of federal 

regulations or legislation, or nominally that we are talking about 

with these changes in pathogens that is unidentifiable? I mean a 

lot of these things there is a valve that didn’t close or didn’t open. 

We have other issues. What do we need to do to be—we would like 

to be from the Federal Government. We would like to be helpful. 

We would like not to be harmful. So give us your things on how 

we can be helpful, and go with Mr. Rodkin. 

Mr.RODKIN. One thing I would say is that while I don’t really 

want to speak for the regulatory bodies, FDA, USDA or CDC, I 

155 

would tell you that if we could have, we as the manufacturers, 

could have access to the information earlier in the process, rather 

than right at the very end it would help us to protect consumer 

health. It would allow us to take any kind of necessary actions 

sooner, rather than having it dumped all at once and then have to 

spring into action. So we would like to be brought into the process 

much sooner. 

Mr.SHIMKUS. I think that is a great response. Thank you. Mr. 

Shoemaker, anything? 

Mr.SHOEMAKER. I think it goes back to your HACCP Program 

and your processes and procedures, and how strict you have your 

HACCP Program. The industry writes their HACCP Program. I 

have had a lot of people come into our facilities and say, you do 

not manufacture product for productivity the way you manufacture 

product and overcooked product and do things for lethality of bacteria. That is what you work for, and that is what we do focus on. 

It is for food safety. And it depends on the degrees within your 

HACCP Program as to how tight you want to do it. You can overdo 

and you can do at a marginal level. Our philosophy is to overdo. 

Mr.SHIMKUS. Mr. Lischewski? 

Mr.LISCHEWSKI. I think one of the areas where we see an opportunity is really more consistency. You know, if you look at our Augusta factory, we run both USDA and FDA products and so in 

some cases we are under two different types of criteria in terms of 

the product that we are producing. 

Mr.SHIMKUS. Mr. Ray? 

Mr.RAY. I would say a very important issue for us is research, 

continued research in food safety. In our particular situation as we 

are dealing with an issue that we have not gotten to the conclusion 

at this point in time, some of the research that we are looking at 

goes back into the early 1980’s. And to be able, as an industry, to 

fund research to learn more about food safety of canned and 

canned low acid vegetables would be very important to us. 

Mr.SHIMKUS. And, Mr. DeLorenzo? 

Mr.DELORENZO. I think that there has to be a clear regulation 

and very definitive regulation as to procedures of processes and 

testing that entire industries have to follow. And there has to be 

complete transparency, and it should work on both sides on part 

of the FDA, USDA and the industry so that any and all records are 

immediately available. There is no such thing as Mr. Eisenberg testified earlier that someone could take a test and then hide it somehow. So this transparency is very important and I think clear and 

definitive guidelines are important. I think on the one big issue 

that concerns me the most is this E. coli problem, and their research is definitely necessary. 

Mr.SHIMKUS. Thank you. And I am going to end with that, but 

I was just going to follow up with a statement. That I found interesting about both panels is the fact that this really goes back to 

real time information. If we are talking about the health and safety 

of the public food source then I don’t care who has information. 

That information needs to go to folks that can take action on that. 

There shouldn’t be a delay, you know, whether it is law enforcement or whether it is proprietary information based upon the people that you are contracted to do testing for. We have got to have 

156 

a way to have the information. The sooner the information, the better. 

So thank you, Mr. Chairman, you have been very generous with 

the time. I yield back. 

Mr.STUPAK. Thank you, Mr. Shimkus. 

Mr. Dingell, for questions, please. 

Mr.DINGELL. Mr. Chairman, thank you. 

Mr. Eisenberg, when a food importer employs your lab to take 

samples and analyze that for submission to FDA, to satisfy the 

agencies requirements under import rules, who owns the rights to 

the results? 

Mr.EISENBERG. The importer. 

Mr.DINGELL. The importer? 

Mr.EISENBERG. We are working for the importer. 

Mr.DINGELL. What are the rights of FDA with regard to that information? 

Mr.STUPAK. Mr. Eisenberg, put your mic on, would you please, 

sir? 

Mr.DINGELL. Does FDA have the right to that information or 

not? 

Mr.EISENBERG. The FDA, in its procedures, requires that we sign 

a laboratory director’s statement that we are submitting all work 

that we have done on a sample. And if an FDA district requires 

that statement we research our records and provide all the work 

that we did. 

Mr.DINGELL. But automatically get that information or not? Is 

there a great toe dance that goes on before they get it or do they 

get it right away as a matter of rights? 

Mr.EISENBERG. Well, in that situation they would get all of it 

right away, however, if the importer tells us not to submit the information to the FDA, the FDA never sees it. 

Mr.DINGELL. Under what circumstances do they keep this from 

FDA? When, how and why? 

Mr.EISENBERG. Well, sometimes they may want to keep a clean 

record on their item, on their food item, with the FDA. 

Mr.DINGELL. So they don’t send it to Food and Drug? 

Mr.EISENBERG. That is right. They don’t submit—they advise us, 

tell us, not to submit the work. 

Mr.DINGELL. Food and Drug doesn’t know what the situation is? 

Mr.EISENBERG. That is right. The importer may re-export the 

product. We don’t know. 

Mr.DINGELL. And that could be something coming in with salmonella or mercury or—— 

Mr.EISENBERG. Sure. 

Mr.DINGELL [continuing]. PCBs or some kind of bacterial or viral 

contamination, right? 

Mr.EISENBERG. Yes. 

Mr.DINGELL. OK. Now, if somebody imports, for example, shrimp 

from China, which is currently under import alert and you test for 

antibiotics or fungicides and find excessive levels what happens to 

your report? 

Mr.EISENBERG. If the importer tells us not to submit it to the 

FDA we don’t submit it to the FDA. If we see something that we 

view as being an imminent hazard to public health, which is very, 

157 

very rare, we advise the importer of this and then we check with 

the importer to make sure that they have reported the problem to 

the FDA. And if they had not reported the problem, then we would. 

We had two situations where importers took our laboratory reports 

and whited out information on our reports that was harmful to the 

entry of the import. In those cases we had no choice. We went to 

the FDA and immediately advised them of what had happened. 

Mr.DINGELL. So it is perfectly legal for you, then, to discard the 

analysis without informing the FDA? 

Mr.EISENBERG. Yes. 

Mr.DINGELL. And you can do that at the instigation or request 

of the importer. Is that right? 

Mr.EISENBERG. Yes. 

Mr.DINGELL. All right. Now, the FDA has made a big point to 

say that it is the private lab, and not the importer, that decides 

from the place in a shipment, that is which bag, box location in the 

container, or where in the warehouse the samples are taken. Is it 

your experience that the importers make such a decision for you 

and/or for your competitors? They decide which parts of the, you 

know, the lot from the import that is going to be scrutinized? 

Mr.EISENBERG. An analysis is only as good as the sample taken. 

Mr.DINGELL. That is correct, because it is not—— 

Mr.EISENBERG. And if we take a sample we will sign a collection 

report that we sampled the shipment without bias. We are not saying that we sampled it in a random way. And if we sign that report 

that we took it without bias then we were responsible for the sampling, and no one directed us as to what the sample, and we did 

our best—— 

Mr.DINGELL. But you are never—— 

Mr.EISENBERG [continuing]. To make sure the sample is representative. 

Mr.DINGELL. But you are not required to make a random sampling are you? 

Mr.EISENBERG. No. And if you have 40 pallets of product it is unrealistic to ask the importer to bring down all 40 pallets to look at. 

Mr.DINGELL. All right. Now, in your statement you say that you 

lost your Miami business, because you could not—rather you would 

not give the importers the results they wanted. Would you supply, 

then, for the records of the committee either publicly or privately 

the names of the importers that chose to move to less reputable 

competitors and have you not delivered that kind of information to 

Food and Drug and the public? To—either publicly or privately? I 

leave the choice to you. 

Mr.EISENBERG. I could try to provide it. 

Mr.DINGELL. All right. Don’t try to provide it, do provide it. And 

we will expect to have it. 

Mr. Chairman, I am not going to ask that that be inserted in the 

record, but I do want to have it. I do want to receive that. 

Mr.EISENBERG. Our Florida laboratory was a branch operation. I 

was advised by our manager of the laboratory on various occasions 

when this occurred, but I was not directly involved. And our manager is now elsewhere, because we closed the Florida laboratory 

due to lack of business and due to the corrupt situation in south 

Florida. 

158 

Mr.DINGELL. All right. Now, in the same vein, will you please 

supply us with the names and the circumstances surrounding each 

instance where you were asked to discard violative findings by a 

client? You can do that either for the record or privately to the 

committee. 

Mr.EISENBERG. That we should be able to do. 

Mr.DINGELL. OK. 

Mr.EISENBERG. And we can simply see all the violations that 

were never reported. 

Mr.DINGELL. We would like to receive that, and we will put it in 

the record or use it in other fashion. 

Now, Mr. Rodkin, you did test the lots of Peter Pan peanut butter that were found to contain salmonella that sickened over 600 

people. Is that correct? 

Mr.RODKIN. That is correct. 

Mr.DINGELL. And your microbiologic testing found two jars contained this toxin, but you failed to inform Food and Drug of the 

finding. Is that right? 

Mr.RODKIN. I am not aware of that specific instance. Can you 

give me the details on that? The timing? 

Mr.DINGELL. It was October. 

Mr.RODKIN. Of? 

Mr.DINGELL. October 2004. 

Mr.RODKIN. I am somewhat aware of that situation, but that was 

prior—I arrived a year later. 

Mr.DINGELL. OK. 

Mr.RODKIN. So I don’t really know the details of that. 

Mr.DINGELL. Now, from October 2004 forward your in-house 

product testing found no salmonella. Is that correct? 

Mr.RODKIN. That is correct. 

Mr.DINGELL. Now, but CDC identified Peter Pan peanut butter 

as the source of the 2007 outbreak. Is that correct? 

Mr.RODKIN. That is correct. 

Mr.DINGELL. Now, in the staff briefings, in the ConAgra testimony of last year, your company blamed the salmonella incident on 

a roof that leaked for a week over late July and early August in 

2006. Is that correct? 

Mr.RODKIN. Everything that we know points to water being the 

source of the salmonella issue. The roof leak was cited as one possibility and the other was a malfunction in a sprinkler system. 

Mr.DINGELL. Now, after the hearing was over, however, the committee learned that FDA took jars of Peter Pan peanut butter from 

ConAgra warehouses in February of last year, that’s 2007, and 

found 14 out of the 130 jars sampled contained salmonella Tennessee. Can you explain why such a large percentage of jars tested 

by Food and Drug discovered the toxin, but ConAgra’s tests did 

not? 

Mr.RODKIN. I am not a scientific expert, but I can tell you that 

salmonella requires water to germinate, to grow, and it takes time 

for that to develop. And our product testing had been done on the 

line when the product was produced. So it is possible to take a significant amount of time for that salmonella to show up. 

Ms.DEGETTE. Will the Chairman yield? 

Mr.DINGELL. Certainly. I would be glad to yield. 

159 

Ms.DEGETTE. That testing that the FDA did though last year 

was after you fixed the roof and the sprinkler system, correct? 

Mr.RODKIN. That testing was on product that had been recalled, 

not on new product that had been produced. 

Mr.DINGELL. So you say this is with regard to product that was 

recalled and not new product for distribution? 

Mr.RODKIN. That is correct. And, in fact, the plant was shut 

down for over six months and totally redone. We did not just repair 

the roof. We totally remade the plant at a cost of many, many millions of dollars, changed all the processes. That is a totally different plant today. 

Mr.DINGELL. Now, we seem to have a difference of opinion here. 

FDA said that this was out of the warehouse and was not from 

samples of the product that was recalled. How do we explain that? 

Mr.RODKIN. Our product—my understanding of that timing that 

you are talking about our plant had been closed, and all product 

had been recalled, and the FDA came in and tested product that 

we had recalled. Potentially that came out of a warehouse and was 

returned to us. 

Mr.DINGELL. Now, I am told that the production dates on this 

particular lot were as late as January 2007, which is some six 

months after the leak in the roof was fixed. How do we explain 

that? 

Mr.RODKIN. I need to make sure I have my dates right. But all 

of—yes. All of the product prior to shutting the plant down was recalled, so that fell into that timeframe. 

Mr.DINGELL. I don’t quarrel with that statement, sir, but I note 

that some of the jars that FDA labs found positive for salmonella 

Tennessee had production dates as late as January 2007. Some six 

months after the leak in the roof was fixed. Now, did ConAgra 

know of the FDA lab results on April 24, 2007, when your vice 

president for manufacturing testified before this subcommittee? 

Mr.RODKIN. I am not aware of that. 

Mr.DINGELL. All right. Does FDA share the results of these kinds 

of tests with ConAgra? 

Mr.RODKIN. That is the normal procedure. 

Mr.DINGELL. And when did they do that here? Do you know? 

Mr.RODKIN. I do not know that specifically. 

Mr.DINGELL. Now, if you got results prior to 4/24/07, then can 

you explain to us how you can blame a leaky roof for samples 

which were marked with a production date after the date that the 

roof was fixed? 

Mr.RODKIN. I’m sorry, sir. I am—I do not know the answer to 

that. 

Mr.DINGELL. Now, what other questions. 

Gentlemen, thank you. Mr. Chairman, I thank you for your courtesy. 

I yield back the balance of my time. 

Mr.STUPAK. Thank you, Mr. Chairman. 

Ms. DeGette, for questions, please. 

Ms.DEGETTE. Thank you, Mr. Chairman. 

Now, Mr. Rodkin, I want to thank you for coming personally 

today. I know it can’t be a happy experience for you, and I am not 

happy myself, because since the beef recall in 2002 we have had 

160 

ConAgra in front of this committee talking about E. coli, salmonella in peanut butter. In your opening statement you didn’t 

talk about the popcorn line, but one of those people actually lives 

in Colorado, my home state. And now here we are with salmonella 

in the pot pies. And the thing that is frustrating to us, as members 

of the Oversight and Investigations Committee, most of us have 

been on this committee for some years now, is every 6 months or 

a year you folks are in with some new problem. And our constituents are stopping us and saying, what can you do to make our food 

safer? So it seems to us that many of the industries represented 

here really are making a good faith effort, including ConAgra, to 

improve the situation, but it is all done in a reactive way. The peanut butter’s contaminated, so you fix the roof. So the popcorn line 

is making people sick, so you take that additive out of the popcorn, 

and on and on. What I am interested in, and I think what Mr. Stupak and the Chairman are interested in and the folks on the other 

side of the aisle, is how can we stop food from being contaminated. 

And one thing that you talked about and that we have talked about 

is these recalls, and so let me ask you first about the recalls in the 

pot pie outbreak and the subsequent recall. Now, ConAgra heard 

about people getting sick on October 8. Is that correct? 

Mr.RODKIN. We first learned of that on Monday, I believe October 11. It was whatever Columbus Day was. 

Mr.DEGETTE. OK. So you learned on October 11. And then you 

said that you immediately issued—that is not right? OK. Staff says 

that is not right. They are saying it is October, Friday, October 8. 

But be that as it may, what happened next was there was a consumer advisory issued, correct? 

Mr.RODKIN. A consumer advisory was, which means telling consumers not to eat the product, and telling—— 

Ms.DEGETTE. And how was that disseminated? 

Mr.RODKIN. I am not aware of the exact details. 

Ms.DEGETTE. OK. 

Mr.RODKIN. But I can tell you it was done in conjunction with 

the USDA. 

Ms.DEGETTE. Now, why wasn’t a recall issued instead of a consumer advisory, which is the next step up? 

Mr.RODKIN. We were working with the USDA and they asked us 

to do a consumer advisory. The next day—— 

Ms.DEGETTE. So it was because the USDA asked you to do it? 

Mr.RODKIN. We were working collaboratively with the USDA. 

Ms.DEGETTE. Well, you know, that is kind of a lawyerly answer. 

Did ConAgra say to the USDA, well, we think we will issue a consumer advisory, and they said OK, or did the USDA say we want 

you to issue a consumer advisory? 

Mr.RODKIN. The—— 

Ms.DEGETTE. That makes a difference to me. 

Mr.RODKIN. We worked together with the USDA. 

Ms.DEGETTE. And you decided jointly to issue a consumer advisory and not a recall? 

Mr.RODKIN. The USDA asked us to do that, and we agreed. 

Ms.DEGETTE. OK, thank you. Now, at some point then was the— 

the pot pies were recalled, correct? 

161 

Mr.RODKIN. The next day after the advisory we at ConAgra decided there might possibly be some consumer confusion, so we decided to make it a total recall of all of our pot pies. 

Ms.DEGETTE. So why did you decide there would be consumer 

confusion? 

Mr.RODKIN. Because we were doing our own analysis and investigation with our customers and consumers, and decided that—— 

Ms.DEGETTE. What did you think they would be confused about? 

Mr.RODKIN. That they might not get the full impact of the advisory, and we wanted to go all the way to a total recall. 

Ms.DEGETTE. OK. And so then you recalled all the pot pies? 

Mr.RODKIN. Correct. 

Ms.DEGETTE. Now, I have introduced legislation the past couple 

years giving the USDA mandatory recall authority. What is 

ConAgra’s position on that legislation? 

Mr.RODKIN. We believe that mandatory recall for any company 

that is not cooperating is fine. We would agree with that. 

Ms.DEGETTE. But you think that the company should have the 

ability to do voluntary recall first? 

Mr.RODKIN. We believe that a company should do what is right. 

Ms.DEGETTE. Right, OK. But your answer, again, was kind of a 

hedge answer, because you said we believe in mandatory recall authority if they don’t do the right thing. 

Mr.RODKIN. If we are presented with the—— 

Ms.DEGETTE. But my question is let us say the USDA is presented with a situation where they have a serious problem with 

some food. And let us say they have a manufacturer who says, well, 

we are going to do some more testing, we are going to do some different things, and then we will decide what to do. Do you think 

that the USDA should have the ability to come in and say, this is 

such a public health risk, we are going to mandatorily recall this 

product? 

Mr.RODKIN. I can’t speak for other companies, but—— 

Ms.DEGETTE. No, I am asking you as the chairman of ConAgra. 

Mr.RODKIN. If it was ConAgra and they presented us with that 

information—— 

Ms.DEGETTE. No, no. I am asking you should they have the ability to do that? Yes or no? 

Mr.RODKIN. For any company that is not cooperating we believe 

mandatory—we would support mandatory. 

Ms.DEGETTE. But if—now, who defines are they cooperating? 

You, the company? 

Mr.RODKIN. In the instance that you just talked about I would 

consider that not cooperating. 

Ms.DEGETTE. OK. Well, who decides that? The company or the 

USDA? 

Mr.RODKIN. The USDA. 

Ms.DEGETTE. Thank you. Now, one last thing. I think a lot about 

this mandatory recall issue, and the problem with mandatory recall 

is once you—or a consumer advisory, once you are doing it that 

horse is out of the barn. That product is out there on the shelves, 

and the mothers are buying the jars of peanut butter and putting 

them on the sandwiches for their kids. They may not—you know, 

I tell you they may not see the consumer advisory, which we don’t 

162 

even know to disseminate it. They may not even know about the 

recall, so this is my question, and I just want you to think about 

this. And if anybody else wants to try me, and I would be happy 

to hear your view. What can we do to beef up the FDA’s and the 

USDA’s power in cooperation with industry to make sure that that 

product is safe when it goes out, so we don’t have to rely on recalls, 

which are a faulty way of getting products back? 

Mr.RODKIN. I think it is incumbent upon the industry to act responsibly, and I believe that we have. We have taken very prompt 

actions as soon as we learned of any issues, spent significant resources proactively. That is time and money to raise our standards, 

made very proactive precautionary change across the entire company. And, in fact, in our approximate $450 million capital budget, 

the number one priority on a go forward basis is safety. 

Ms.DEGETTE. So you don’t really think anything in addition can 

be done, except for the industry making a commitment? 

Mr.RODKIN. I think the primary responsibility is on the industry, 

and also to cooperate 100 percent are priorities. 

Ms.DEGETTE. Because they have done such a swell job so far. 

Thank you very much, sir. 

Mr.STUPAK. I hate to say this to this panel, but we have got 

votes again. They told us it would be awhile, but obviously they 

were wrong in their guesstimation. We have got about three minutes left—the votes. And we got a Motion to Recommit, so it is 

probably going to be 3:15 by the time we get back, so we are going 

to stay in the recess until 3:15. Other members have expressed interest about asking the panel’s questions of this panel. So we are 

going to ask the panel to hold. 

3:15, see you back here at this time. We will stand in recess. 

[Recess.] 

Mr.STUPAK. OK. The Committee will be back in order. 

Let me remind all witnesses we are still under oath. Sorry about 

the delays. We thought we were just going to have a few votes, and 

it ended up being more than what we thought. But the good news 

is we are done with votes, so hopefully we can get this panel done, 

and we can finish up today. The bad news is the SCHIP hearing 

is done so members may be coming in for more questions. 

Let me go with the questions. Again, everyone is under oath. 

Mr. Rodkin, if I may, I hate to continue to bring up this about 

the salmonella, but we were just getting conflicts in answers up 

here from facts of what we know. And then as you know this came 

up at a previous hearing, so we are getting conflicting information. 

In response to the peanut butter contamination outbreak has 

ConAgra gone back and tested products for salmonella on peanut 

butter? 

Mr.RODKIN. Yes. 

Mr.STUPAK. OK. 

Mr.RODKIN. We certainly have on an ongoing basis with much 

more rigorous testing in a totally renovated and revamped new 

plant. 

Mr.STUPAK. OK. And in that testing ConAgra found, have they 

not, they found salmonella in peanut butter produced in 2004, 

2005, 2006, 2007? 

163 

Mr.RODKIN. The only peanut butter that I am aware of that was 

tested for salmonella was in 2006. I am not aware of the other 

dates. 

Mr.STUPAK. So you don’t know in 2004, 2005 or 2007? You are 

not aware of it? 

Mr.RODKIN. I am not aware of those dates, just 2006. 

Mr.STUPAK. OK. For the record would you go back and check 

with your folks—— 

Mr.RODKIN. Yes. 

Mr.STUPAK [continuing]. And get this thing cleared up once and 

for all? 

Mr. Eisenberg, if I may. In your testimony, page 2, it says the 

purpose of the PICSC, Pacific Import Community Steering Committee, right, was to provide a conduit for information from the 

FDA to the regulated import community, and from that community 

back to the FDA in the public interest to assure and improve FDA’s 

regulation of imports. The three sections would meet three times 

a year by televideo conference. It says the FDA ended its involvement or sponsorship of the PISCA in early 2006. Is that correct? 

Mr.EISENBERG. Yes, that is correct. 

Mr.STUPAK. Why did they end this relationship where private industry is trying to work with you and others to detect import problems and imports with food? 

Mr.EISENBERG. Well, they advised me that they were meeting 

with different groups, and that they were creating different groups 

that they wanted to meet with. And they were no longer interested 

in meeting with the PISCA group. 

Mr.STUPAK. Did they give you any indication of what these other 

groups—who these other groups were? 

Mr.EISENBERG. No. 

Mr.STUPAK. OK. Who terminated this? Who did you learn this 

from at the FDA? 

Mr.EISENBERG. Mark Rowe, the acting regional director. 

Mr.STUPAK. OK. In a question—in your answer to a question 

that Chairman Dingell, that because of the corrupt situation in 

south Florida you closed your office. Explain that. 

Mr.EISENBERG. Well, first of all, the FDA had deregulated or was 

not enforcing their regulations with regard to pesticides residues, 

especially in snow peas. So a significant part of the market, of the 

business down in south Florida, had evaporated. It no longer existed. But also we were the first people to open a laboratory in 

south Florida, and we worked, we spent a lot of money, we tried— 

we did excellent work. But along the way a gentleman who had actually worked for us for six months left and set up his own laboratory with two leased gas chromatographs. A Dunn and Bradstreet 

report indicating $68 is the maximum amount of his assets or 

whatever, and the FDA accepted his reports on an equal basis. And 

I, you know, his—I cannot prove it, but I do not have confidence 

that all the work that he did was honest. 

Mr.STUPAK. OK. Is your lab certified by the FDA? 

Mr.EISENBERG. The FDA does not certify any laboratories. It 

doesn’t accredit. What it has done is it will disqualify labs that it 

finds due to deficient work. 

Mr.STUPAK. OK. 

164 

Mr.EISENBERG. And we are not disqualified. We do work nationwide and we are not disqualified. 

Mr.STUPAK. Well, when there is an alert and you are asked to 

test a product, a company comes to you and says I got to get this 

import alert lifted, I have to test this product. It has to be tested, 

what three times, before it is allowed to continue on? 

Mr.EISENBERG. At least five times, then the importer must file 

various paperwork that I am not—— 

Mr.STUPAK. OK. 

Mr.EISENBERG [continuing]. Knowledgeable about. Sometimes, 

though, the FDA may say, well, we are not satisfied with five clean 

shipments. We want 10 before we even go and review the paperwork. 

Mr.STUPAK. Well, whatever the number is. 

Mr.EISENBERG. Normally a minimum of five shipments. 

Mr.STUPAK. And when you do tests, the test results go to who? 

The FDA or their client who asked you to do their tests? 

Mr.EISENBERG. We generate the results and then we request in 

writing from the importer confirmation that we should submit the 

results to the FDA. 

Mr.STUPAK. OK. If you do not get a confirmation from the importer what do—are you allowed to ship those results into the FDA 

or not? 

Mr.EISENBERG. We are afraid of—we have a fiduciary relationship to our client, so if they tell us not to submit the results we 

don’t submit them. 

Mr.STUPAK. Do you know of any reason why any tests your or 

any other lab does should not simultaneously, whether it is a positive or a negative, go to the FDA and to the client shipper? 

Mr.EISENBERG. I think it absolutely should go to the FDA concurrently with when it goes to the shipper, but this is not the—this 

is not in the FDA rules at this point in time. 

Mr.STUPAK. Right, correct. OK. 

Mr. Lischewski, if I may, a couple questions. You indicated in 

testimony that Castleberry products were recalled due to risk of 

possible botulism contamination, correct? 

Mr.LISCHEWSKI. Correct. 

Mr.STUPAK. Aren’t there about 90 products that were looked at 

possibly that might have been contaminated? 

Mr.LISCHEWSKI. Correct. 

Mr.STUPAK. And, I think, you said in your previous testimony 

that two products were found to have problems? 

Mr.LISCHEWSKI. That is correct. 

Mr.STUPAK. And these two products you had the lot codes and 

you were able to recall what they were. Is that correct? 

Mr.LISCHEWSKI. Yes. 

Mr.STUPAK. OK. Botulism typically occurs in low acid canned 

foods when those cans are not heated long enough and to high 

enough temperatures that kill the spores that could cause botulism, correct? 

Mr.LISCHEWSKI. Correct. 

Mr.STUPAK. OK. And did you tell our committee staff that botulism contamination on your products occurred when certain prodVerDate Nov 24 2008 15:34 Aug 10, 2009 Jkt 037690 PO 00000 Frm 00170 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-92 SCOM1 PsN: JIMC
165 

ucts were not heated to a high enough temperature to kill the 

spores which cause botulism? 

Mr.LISCHEWSKI. Yes, that is correct. 

Mr.STUPAK. OK. And is it true that under the heating process 

was caused by a malfunction of a valve at the bottom of your retort 

system? A system that heats the canned foods? 

Mr.LISCHEWSKI. Yes. 

Mr.STUPAK. And because of the type of food that you produce 

both FDA and USDA would be in your Augusta, Georgia plant 

where this botulism problem may have occurred, correct? 

Mr.LISCHEWSKI. USDA was at the factory every day. 

Mr.STUPAK. USDA. 

Mr.LISCHEWSKI. But FDA was also there. We produce products 

and they are both jurisdictions, but FDA only comes on an inspection basis. 

Mr.STUPAK. OK. This malfunctioning valve, explain that to us. If 

FDA’s there and if that is one of the areas or USDA—if that is one 

of the areas you check, I’m curious, why didn’t anyone catch it? 

Mr.LISCHEWSKI. The valve basically, the type of equipment that 

we used for sterilization, is produced by a company called Malo. 

And what happens is these tanks are full of water, product— 

canned product goes in, water is pumped out—— 

Mr.STUPAK. Correct. 

Mr.LISCHEWSKI [continuing]. Through this valve and steam is applied to sterilize. 

Mr.STUPAK. 

Mr.LISCHEWSKI. The malfunction of the valve allowed some 

water to stream back into the bottom of the container such that 

some of the cans were submerged in water. The design of these 

particular retorts did not allow for any reporting of temperatures 

at the bottom of—— 

Mr.STUPAK. How about visually? I mean visually wouldn’t you 

see the water in the cans? 

Mr.LISCHEWSKI. No, these are stainless steel containers. 

Mr.STUPAK. Right, these retorts. 

Mr.LISCHEWSKI. You can’t see inside of them. 

Mr.STUPAK. OK. 

Mr.LISCHEWSKI. So, again, normally we look at pressure gauges 

and we look at temperature gauges to monitor the performance of 

the retort. The small amount of water in the retort didn’t allow us 

to see any deviations in the pressure. And the fact that there 

weren’t temperature gauges throughout at the bottom of the container we couldn’t see the difference in temperatures. 

Mr.STUPAK. So in your situation it was both the water plus temperature? 

Mr.LISCHEWSKI. Correct. The fact that cans were in the 

water—— 

Mr.STUPAK. Right. 

Mr.LISCHEWSKI [continuing]. And the steam was going onto the 

regular cans, but that particular water caused a partial sterilization. So that when we went through our normal quality protocol 

post processing where we normally would have picked up an under 

processed product the fact that some heat had been applied meant 

166 

it went through our normal process, and didn’t basically grow the 

botulism bacteria until after it has been released. 

Mr.STUPAK. So when your finished product was done—— 

Mr.LISCHEWSKI. Yes. 

Mr.STUPAK [continuing]. Before you shipped is there testing then 

that you do? 

Mr.LISCHEWSKI. Yeah, we basically—— 

Mr.STUPAK. Or does it—— 

Mr.LISCHEWSKI. Once the product is finished, the day after processing, we do an organ analeptic evaluation of the product. And we 

also put the product on a three day incubation, so if a product had 

not been sterilized then that product would swell and we would 

pick it up before it ever went into our distribution channel. Given 

that it was partially sterilized and there were no control mechanisms within the Malo retort that allowed us to see that or see 

variations that product actually made it through our process. 

Mr.STUPAK. And you said swell. You mean the can itself would 

swell? 

Mr.LISCHEWSKI. The can itself. If it wasn’t sterilized the protein 

inside would swell and you would be able to notice it in the product. 

Mr.STUPAK. And that would occur within three days? 

Mr.LISCHEWSKI. Yes. 

Mr.STUPAK. OK. 

Mr. Ray, let me ask you then, because in the FDA reports I saw 

you actually had swelling in the cans from what the FDA said. 

Right in front of you is a book there, sir. You may want to go to 

Tab No. 41. This is—and the reason why I want you to go there 

is it is form No. 483 of the FDA. Because in your testimony you 

stated our investigation is still underway and we have not yet determined—have not yet—excuse me. Have not yet received key information from the FDA about their findings. But when I look at 

this reform here, this form 483—— 

Mr.RAY. Um-hum. 

Mr.STUPAK. It looks pretty clear to me. You received form 483, 

right? You are familiar with that form? 

Mr.RAY. Yes, we did on February 15. 

Mr.STUPAK. OK. And the FDA confirms that botulism spores 

were found in four cans, correct? 

Mr.RAY. That is correct. 

Mr.STUPAK. OK. And is it not true that the botulism spores were 

found in four water wells that the company uses? 

Mr.RAY. That is correct. 

Mr.STUPAK. OK. And before you use these water wells didn’t you 

use to use water that was treated with chlorine? 

Mr.RAY. That is correct. Well, we used—— 

Mr.STUPAK. Chlorine would kill the botulism spores, right? 

Mr.RAY. No, that is not correct. 

Mr.STUPAK. OK. But, OK, so they found it in cans and they 

found it in the wells. Then the company used the water from these 

wells to cool the cans after they have been cooked, right? 

Mr.RAY. That is correct. 

167 

Mr.STUPAK. OK. Then is it not true that the FDA believes that 

botulism spores entered the cans through loose seams after being 

cooked while the cans were being cooled? 

Mr.RAY. That is correct. You had asked about the chlorination. 

The chlorination for the drinking water levels would only be probably one to two parts per million. 

Mr.STUPAK. Sure. 

Mr.RAY. To actually destroy the C.bot spore—— 

Mr.STUPAK. Sure. 

Mr.RAY [continuing]. It would have to be probably 10 to 20 times 

that. 

Mr.STUPAK. But to use these wells you had to check to see if they 

contained any spores or any bacteria that might be harmful in your 

food process did you not? 

Mr.RAY. No, we did not. That is not normal process. We would 

do potability testing. We would test the water every four months 

and return the information to the district health department. 

Mr.STUPAK. Then how did the botulism spores then get in these 

four wells then? 

Mr.RAY. We did not anticipate or did not test for—in history 

prior to FDA drawing samples we had never tested, nor is it industry practice, to test—to have botulism in water wells, or botulism 

spores, I should say. 

Mr.STUPAK. The FDA stated that the post process botulism contamination in low acid canned food products has only occurred 

about four times since 1940. It is very rare for this to happen. 

Mr.RAY. Right. 

Mr.STUPAK. But the FDA determined that you manufactured 

multiple lots of low acid canned foods with lose seams, and that 

was—and the company was aware of the lose seams before the 

FDA investigation was it not? 

Mr.RAY. No, we were not, sir. 

Mr.STUPAK. Well, in that form right there at observation #6. 

Mr.RAY. OK. 

Mr.STUPAK. Does it not indicate that the company was aware of 

the lose seam problem? 

Mr.RAY. Observation #6. The observation I see in front of me was 

that the FDA came in and made an observation that they felt that 

some of our technicians were not properly evaluating the double 

seams. 

Mr.STUPAK. Right. And that, therefore, you didn’t have any many 

as you should have in these cans which would cause problems with 

it? 

Mr.RAY. As many—I don’t understand the question. 

Mr.STUPAK. You were supposed to have somebody crimping the 

cans are you not? 

Mr.RAY. Well, the condition of the seam itself is evaluated by a 

technician. 

Mr.STUPAK. And you didn’t have a qualified individual who could 

detect that. Is that not what they found? 

Mr.RAY. We felt—they—we felt we had qualified technicians. 

Mr.STUPAK. You felt that, but the FDA did not? 

Mr.RAY. That is correct. 

168 

Mr.STUPAK. OK. In your testimony you stated that botulism 

spores are regarded as so unlikely to be found in water that testing 

was not a standard procedure. But isn’t there a regulation that 

states that low acid canned food manufacturers must chlorate their 

water or sanitize the cooling water used in the process? 

Mr.RAY. I believe it does depending on the use of the water, sir. 

Mr.STUPAK. And it is also on that finding that you didn’t consistently do this. Either use the chloride water or sanitize cooling 

water used in your process, correct? 

Mr.RAY. There was a point in time that our former quality service manager had through some corrosion studies ceased using chlorine. That was a mistake. 

Mr.STUPAK. Right, it is observation no. 7 there. So the bottom 

line on this whole thing was number one, you didn’t have a qualified person to check on the cans and the crimping that which led 

to lose seams, which is susceptible to botulism contamination. And 

you didn’t treat or test the water that might enter the cans 

through these lose seams, which could have lead to botulism, correct? Those are the two findings of the FDA. 

Mr.RAY. Well, I think the one thing to make clear about is that 

chlorination, that the chlorination of drinking water, it was not sufficient enough to destroy the C. botulism spores. 

Mr.STUPAK. Well, again, looking at Exhibit 41 there, here is what 

the FDA observed. That you failed to properly evaluate defective 

lots in a timely manner to assure that there are no potential public 

health hazards associated with your finished products. Your firm’s 

employees did not conduct a complete spoilage diagnosis to determine whether spoilage was due to under processing or post process 

leakage. Corrective action was not taken in a timely manner to remove and destroy defective spoiled cans, to fix the problem causing 

the spoilage, whole or portions of effective lots were observed with 

swells, buckled or defective seams in the warehouse. Isn’t that correct? 

Mr.RAY. That is what the work order says, sir. 

Mr.STUPAK. You don’t feel your company was responsible for 

that? Well, I think I would like to ask—maybe you don’t want to 

admit it. 

But Mr. Lischewski was telling us about the can would swell 

within the three days. Your company actually had employees take 

the swelled cans and put them in a process where they pressed the 

can back to basically hide the swollen cans, right? 

Mr.RAY. We had debuckled—back several years ago there was 

some debuckling of cans by some employees. I think in 2005. 

Mr.STUPAK. Well, according to the FDA your firm, and again I 

am reading from the report now, reshaped cans of LACF products 

that exhibited evidence of buckling by using a hand press to push 

the can ends back into place. These debuckled cans were then released from the hold status and made available for sale to your 

customers. Isn’t that true? 

Mr.RAY. That is correct. 

Mr.STUPAK. So I mean if you didn’t know about the water, you 

didn’t know about crimps or the seams, you certainly knew about 

the buckling. You certainly knew you had a problem, but you continued to sell them to your customers. 

169 

Mr.RAY. The circumstances of what you are talking about were 

two very different points in time. The buckling of the cans occurred 

based on recommendation of our can supplier back, I believe, in 

2005. The situations in which we are talking about in these observations are defective lots that were—observation 1C, for example, 

that we had defective lots that we did not handle on a timely basis. 

Those defective lots were lots that we had identified as processed 

deviations. 

Mr.STUPAK. Right. But this is from November 26, 2007 to February 15, 2008, top right-hand corner. I mean that is when this report is, and that is when they found these cans and your 

debuckling. 

Mr.RAY. We would to—I’m sorry, sir. Could you repeat the question? 

Mr.STUPAK. Sure. You said that they were from some time, but 

this report, this 483, Exhibit—— 

Mr.RAY. Um-hum. 

Mr.STUPAK [continuing]. Report 483. Actually date of report is 

11/26/2007 it looks like 2/16/2008, right? 

Mr.RAY. That is correct. 

Mr.STUPAK. So these findings were during that period of time, so 

they weren’t from 2005. 

Mr.RAY. The debuckling was from a prior time. 

Mr.STUPAK. So you still had the cans on the premises? 

Mr.RAY. No, we did not, sir. We had them at a prior time. 

Mr.STUPAK. Mr. Lischewski, the buckling of cans and them 

pressing them back is that a standard procedure within the industry? 

Mr.LISCHEWSKI. No. 

Mr.STUPAK. OK. Mr. DeLorenzo, let me ask you this. We had testimony here—and I think last we were talking about E. coli spinach and lettuce and all this. That we have had about 20 outbreaks 

in the Salinas Valley within the last 10 years, correct? 

Mr.DELORENZO. I am not sure how many. 

Mr.STUPAK. Somewhere around there. About every 6 months we 

seem to have one of these. I’m sorry. You got to turn on your mic. 

Has Dole—you are the largest producer in that area, or processor. 

Have you done anything to try to figure out what is going on here? 

It seems like if you have one of these salad problems, E. coli, problem, every 6 months you want to do something. I mean I have 

asked the FDA the same question, and they just look at me like, 

you know, what to do. I mean an epidemiology study I have suggested to them. Have you suggested anything like that? 

Mr.DELORENZO. Yes. I think the industry is desperate to make 

sure there are no more incidents or recalls. As I described, the industry got together and has put a very, I think, significant food 

safety processing and protocol in place for the farming and processing. I personally co-funded just a few months ago a seminar 

here in Washington, because I wasn’t satisfied either with the answers that we are getting. That this E. coli is prevalent and nobody 

has a kill step, and nobody is exactly sure where it is coming from. 

So we had a seminar—— 

Mr.STUPAK. And what did you learn from that seminar? 

Mr.DELORENZO. I learned that we—— 

170 

Mr.STUPAK. No answer? 

Mr.DELORENZO. No answer. We had 70—we had approximately 

70 scientists from Academia. We had the USDA, FDA scientists. 

And my, perhaps naively, agenda was to come away from that after 

two days of being here with all these people who had studied this 

for many, many years, mostly out of the meat industry—that is 

where most of the E. coli studies have come from. Basically what 

they—the conclusion was A, that they are not sure where it comes 

from. Obviously cattle is the primary—cattle droppings is the primary cause. They are not sure how it migrates. They are not sure 

how it lives, is able to live in the environment that we have. They 

are not sure how it avoids the kill step in the chlorine wash that 

we have. 

Mr.STUPAK. Well, then we would—irradiation that we talked a 

little bit about today. Would that help solve this problem in the Salinas Valley? 

Mr.DELORENZO. We have an irradiation—we had an irradiation 

expert from, I think, he was from Texas, and we are still working 

with him. Unfortunately, with irradiation of fresh produce it tends 

to cook the product so we haven’t gotten over that one yet. But we 

are actually going to be funding some work that he is going to be 

doing. And I will admit it is very, very disconcerting when it comes 

to E. coli. 

Mr.STUPAK. Well, let me ask you this. The produce industry had 

called on the FDA to enter tough new regulations regarding the 

handling of fresh produce; however, the FDA has not done this. It 

has been reported that earlier this year the FDA came up with new 

regulations on handling of fresh produce. These regulations were 

intended to replace existing voluntary guidelines. That is what is 

in place now, right? And according to the Wall Street Journal, May 

16, 2007, the FDA proposal, and I am quoting now, went nowhere 

after it got a cold reception from the Department of Health and 

Human Services. The article states the FDA plan, which would 

have cost $76 million over three years was rejected after it was 

presented in February at HHS headquarters. Would you want to 

see mandatory regulations? 

Mr.DELORENZO. Yes, I would. 

Mr.STUPAK. OK. Were you involved in helping to put together 

any of these mandatory, or Dole or anyone, putting together these 

mandatory regulations that were presented to the secretary in 

2007? 

Mr.DELORENZO. Let me—do you mind if I just ask a question, because I wasn’t—— 

Mr.STUPAK. Sure. 

Mr.DELORENZO [continuing]. At the company at that time? I 

guess we were involved indirectly through the trade groups, and 

then directly in California with the Leafy Greens Agreement that 

the industry put in place. 

Mr.STUPAK. OK. 

Mr.SHIMKUS. Can I—— 

Mr.STUPAK. Sure, go ahead. Jump in. Mr. Shimkus wants to 

jump in, and we might go back and forth here for a bit. Go ahead. 

Mr.SHIMKUS. I was just going to give you a chance to get your 

breath. 

171 

Mr.STUPAK. I am just getting warmed up. Go ahead. 

Mr.SHIMKUS. That is what I am afraid of. The—just going back, 

Mr. DeLorenzo, just on the timeline. The spinach that we are talking about, you were a purchaser of that, correct, and then have you 

now changed the processes where you are the producers now? It is 

more in-house where you are attempting to try to get control? 

Mr.DELORENZO. Yes, we agree. 

Mr.SHIMKUS. That is kind of the timeline then I heard. 

Mr.DELORENZO. Right. We are taking everything in-house now. 

Mr.SHIMKUS. And that—why are you doing that? 

Mr.DELORENZO. Well, I am doing it more just to make sure that 

we have complete control over the processes. And I am not trying 

to blame the other company, because I think it was a reputable 

company. But there is enough—in the fresh business there is 

enough variables that I just felt it was important to have everything in-house. 

Mr.SHIMKUS. I mean I heard that in the opening and the questions, and I think that when you—I mean you have better control 

of the operation when it is yours. And obviously there are risks 

in—— 

Mr.DELORENZO. Can I jump in? 

Mr.SHIMKUS. Yes. 

Mr.DELORENZO. Are you talking about the Natural Selection 

one? The hearing we had last time, Natural Selection? 

Mr.SHIMKUS. Yes. 

Mr.DELORENZO. Natural Selection have seen then testified that 

they have gone through and testified the leaf as they process it 

now. 

Mr.SHIMKUS. Yes. Did you do that or do you still rely upon Natural Selection or—— 

Mr.DELORENZO. We are doing our own testing. As I said since 

that incident we have done over 4,000 tests on our products both 

field and in processing, and so far they have all come up negative. 

Mr.SHIMKUS. OK. What you and Natural Selection are doing, is 

that the exception to the rule or do most producers now do that? 

Mr.DELORENZO. No, I think most producers. The Salinas Valley 

is very, very motivated to eliminate this problem, because every 

farmer’s livelihood is based on this. And so I think that there has 

been a very good industry movement. More than I—— 

Mr.SHIMKUS. OK. Natural Selection said they were the only one, 

you would be second. So this would all be since September of 2007, 

I think, was the last recall. 

Mr.DELORENZO. I am not sure how much testing every company 

is doing, but I am pretty sure all the large companies are testing. 

Mr.SHIMKUS. Thank you. 

The—Dr. Brackett you have been on the end there, quiet, and 

just a couple questions to you. Mr. Eisenberg testified that when 

you were assistant and director you advised, in June 2006, that 

FDA would no longer monitor pesticide residues in foods because 

the agency did not consider the residues a serious matter. Can you 

comment on this? 

Mr.EISENBERG. Yes, Mr. Shimkus. I am glad I have the opportunity to respond to that. In fact, I never did say that we didn’t 

consider it a serious matter. Any violation of the law was a serious 

172 

matter. And it wasn’t just IFT, but in other locations I said with 

the limited amount of resources we were going to focus on those 

things that had the biggest public health impact at that time. So 

if it was a matter of testing for something that was killing children, 

like E. coli 157H7 or a violative pesticide, we were going to go on 

saving children. 

Mr.SHIMKUS. Mr. Eisenberg, you state you lost business because 

of this. Can you restate that for us, please? 

Mr.EISENBERG. I’m sorry. Can you repeat the question? 

Mr.SHIMKUS. You—I am just restating that you, because of the 

decision, you closed down operations, lost business. I mean I am 

just—— 

Mr.EISENBERG. That is correct. The FDA had substantially reduced the number of shipments that it stopped for detention without physical examination, analysis and sampling. And then what 

little work was left was being taken by a laboratory that we could 

not compete with. 

Mr.SHIMKUS. Mr. Brackett, based upon the testimony you have 

heard today, do you believe that the case studies and, you know— 

that is what we have in a multitude of different aspects. Do you 

believe that the case studies are representative of general problems 

found in the food processing arena? 

Dr.BRACKETT. Well, I think it is a good selection of the type of 

problems that could be found. You have got a variety of different 

commodities oriented here, and they all have similar—well, they all 

have differences because of the science involved, but they all have 

some similarities too, and they all point to five different things that 

we can think of. One of which is that we have got to resource the 

regulatory agencies so they can oversee the industry the way that 

would help them. Secondly, we think that it would help if the industry as a whole was mandated to have a plan where they actually looked down the line what was going to happen and then had 

remediation steps to deal with those. Thirdly, also to be able to, as 

Mr. DeLorenzo said, we do believe that they should have some sort 

of mandatory baseline safety rule for produce industry, again, to 

make sure that that is taken care of. And secondly, also, which was 

in our pillar one at the Grocery Manufacturers Association, to 

make sure that importers require of the companies that are importing to them documentation of the safety practices that they are engaged in so that we can facilitate commercial. And then of course 

part of this that we have talked about too is supporting mandatory 

recall when the manufacturer delays or refuses to do it. 

Mr.SHIMKUS. And finally, just going back, Mr. Brackett, and you 

kind of mentioned it on the import end, because on the first panel 

we had the—Mr. Williams talked about some of those challenges 

that they are facing. Anything in that first panel that you could respond to, to help clarify some of the testimony there? 

Dr.BRACKETT. With respect to which part are you asking? 

Mr.SHIMKUS. Well, I mean obviously formerly with the FDA 

there was a lot of—while you served, you know, there. And I was 

just giving you the opportunity to respond to anything that you 

thought that you may need to respond to out of the first panel. 

Dr.BRACKETT. Well, I think out of the first panel probably what 

Mr. Marler said was probably the most significant is there is a lot 

173 

of calls for regulations, and while I was there were called for regulation standards, and in some cases they are needed. But a regulation based on no or bad science is going to be more problematic for 

the industry than putting something out there. We do have to have 

more science. We need to have that as a foundation of our regulations, but there are things that we can do now, and some of the 

things I just mentioned a moment ago are some of them. 

Mr.SHIMKUS. Thank you, Mr. Chairman. 

Mr.STUPAK. Thanks. 

Mr. DeLorenzo, if I may, 2005 Dole had a recall. What was that 

on? Spinach? Do you know? E. coli? It was something. I forget what 

it was. 

Mr.DELORENZO. We did have a recall on E. coli in 2005 also. 

Mr.STUPAK. Was that on spinach or lettuce or—— 

Mr.DELORENZO. No. I think it was other leafy greens. 

Mr.STUPAK. OK, OK. In your testimony you gave me the impression that Canadians had a recall on your product there in 2007, 

possible E. coli, on packaged salad. And you didn’t believe the Canadians or—— 

Mr.DELORENZO. No, we—— 

Mr.STUPAK. I got the impression. I mean—— 

Mr.DELORENZO. No, no, no. We immediately had a recall. What 

happened is that when you have a—when we had the recall we 

pulled in product and we tested everything that—all product that 

came in from consumers. 

Mr.STUPAK. Right. 

Mr.DELORENZO. From the Canadians that they had, and from 

whatever products we retained in the plant. Whenever we run the 

plants we retain products off the line—— 

Mr.STUPAK. Right. 

Mr.DELORENZO [continuing]. So that we have the bags that we 

can go back to. So all of those came up negative. There was no 

sight of the E. coli. There was also no sign of E. coli when the different federal and state agencies came through and the Canadian 

government came through. Our plants and our farms. So the only 

thing I said is it remains a mystery of where this came from and 

how it happened and how we could prevent it again. And so there 

is a possibility it could be a laboratory error. That is always a possibility, but we are not taking it as a laboratory error. We are saying that science says that this is possible. There could be one cell 

out there—— 

Mr.STUPAK. Right. 

Mr.DELORENZO [continuing]. In one bag at any time. 

Mr.STUPAK. Well, the—— 

Mr.DELORENZO. That is what we really need to do the research. 

Mr.STUPAK. And I think that is a good point based upon your 

earlier testimony. This Canadian example, because all this costs, 

all the follow-up with bags that were out there could have been a 

laboratory error, right? 

Mr.DELORENZO. It is always possible, yes. 

Mr.STUPAK. I mean so there—that was a huge response. 

Mr.DELORENZO. Yeah. I think that one thing that we would like 

to do in any regulation is that I think that there should be transparency on both the regulating side and the company’s side. I think 

174 

the company’s records should be an open book on any kind of—we 

did ask the Canadian government if we could go look at the tests 

just to double check them. 

Mr.STUPAK. Right. 

Mr.DELORENZO. And we weren’t allowed access to it. But that 

is—we are not saying it wasn’t. 

Mr.STUPAK. Well, have you ever done a recall and then found out 

later the tests were all wrong? I mean before there is a recall, let 

us face it, there are tons of tests, right? 

Mr.DELORENZO. Well, in this case there was just one bag of— 

they had—— 

Mr.STUPAK. OK. 

Mr.DELORENZO. As I understand it there is a number of bags of 

lettuce that they did, and in one bag they found E. coli. And when 

we went back to double—we did go back and asked can you do 

more testing on that bag, but there was nothing left. They said it 

had been destroyed. 

Mr.STUPAK. Well, let me ask you this. Because you said in your 

testimony, you talked about Dole’s testing for pathogens. You said 

you test for pathogens in the field prior to harvest. You test pathogens that enter your processing plant, and you test produce as it 

leaves as a finished product. How many companies do that? I mean 

you got three testing processes going on here, right? 

Mr.DELORENZO. And we test water also in the field. 

Mr.STUPAK. OK. 

Mr.DELORENZO. So it is four. 

Mr.STUPAK. All right. 

Mr.DELORENZO. Let me—may I just ask our—— 

Mr.STUPAK. Sure. 

Mr.DELORENZO. He is saying that all of the major—he believes 

that all of the major vegetable companies in the Salinas Valley are 

doing it. 

Mr.STUPAK. That is all since about 2007 then, right? 

Mr.DELORENZO. Yes. 

Mr.STUPAK. OK. 

Mr.DELORENZO. Since the spinach. 

Mr.STUPAK. When you test the water do you test the water you 

use in other countries? I mean some of your products come—— 

Mr.DELORENZO. Yes. 

Mr.STUPAK [continuing]. From Mexico and other areas. 

Mr.DELORENZO. Yes. 

Mr.STUPAK. OK. Mr. Brackett, just a couple of questions if I may. 

You were at the FDA and the agency essentially, from our point 

of view, set back in a passive position and relied on companies to 

follow voluntary guidelines to ensure the safety of food. Do you believe in relying on voluntary guidelines is still a sufficient means 

to protect our Nation’s food supply? 

Dr.BRACKETT. Well, Mr. Chairman I think it depends on what 

you are talking about the voluntary guidelines do. I think there is 

a role for a baseline set of mandatory standards that can be done 

if you have got the scientific information done. But then there 

are—— 

Mr.STUPAK. But what do we have right now? We have voluntary 

standards, right? 

175 

Dr.BRACKETT. Well, there are still some—— 

Mr.STUPAK. As a general rule it is a voluntary standard. 

Dr.BRACKETT. Food, Drug and Cosmetic Act. So—— 

Mr.STUPAK. Right. 

Dr.BRACKETT [continuing]. For adulterated food that is mandatory. The specifics is where really guidance fits in better and where 

you are going to have a change in some of the knowledge. That is 

where guidance needs to be used. 

Mr.STUPAK. So is—you are now with the Grocery Manufacturers. 

Are you for voluntary or do you want to see mandatory guidance 

in this area? 

Dr.BRACKETT. Both. I think that there is a place for mandatory 

standards on which you place voluntary guidelines. 

Mr.STUPAK. OK. So Grocery Manufacturers, like Dole is doing 

right now. 

Dr.BRACKETT. Um-hum. 

Mr.STUPAK. They are testing the field, testing the plant, testing 

the finished product and they test all water sources. Do you think 

that should be mandatory or voluntary? 

Dr.BRACKETT. No, I don’t think that part should be mandatory. 

I think that—— 

Mr.STUPAK. Why not? 

Dr.BRACKETT [continuing]. Testing is sort of a mistaken way of 

protecting the product if you have no other preventative controls to 

rely on. 

Mr.STUPAK. What point should it be tested then? 

Dr.BRACKETT. Well, I think—— 

Mr.STUPAK. If it is not in the field, if it is not in the processing 

plant, if it is not in the water, if it is not in the finished product, 

where should we test it? 

Dr.BRACKETT. Well, the place for testing that is not the issue 

here. The issue is it shouldn’t become contaminated in the first 

place. The work has to be done to prevent contamination. If you 

have no kill step, if you have no other way then you should be testing the water and—— 

Mr.STUPAK. But we don’t live in a perfect world. 

Dr.BRACKETT. No. 

Mr.STUPAK. OK. 

Dr.BRACKETT. But until we get to a point where we can use irradiation or something else there is a role for testing, but being—— 

Mr.STUPAK. Well, what testing would your organization, Grocery 

Manufacturers Association, what testing would you support? I 

mean the only testing we really have right now are people getting 

sick. 

Dr.BRACKETT. Well, that is right, and we can’t have people getting sick. But the point is, is that testing is such a prescriptive action that if you mandate that, any particular type of test, that prevents better tests from being developed. We want whatever is used 

to be the very best that science provides, and that is a moving target. 

Mr.STUPAK. It is a moving target? 

Dr.BRACKETT. Right. 

Mr.STUPAK. So these 91 recalls we have had in the last 14 

months since it is a moving target we can continue to expect it? 

176 

Dr.BRACKETT. No. I think we need to drop that. I want to Mr. 

Marler out of business. The way you use testing is in conjunction 

with the regulations that you talked about together with the best 

processing practices that you talk about. There is a role for testing, 

but putting that into a rule is not the most appropriate use for it. 

Mr.STUPAK. And you can’t articulate what testing should be? 

Dr.BRACKETT. Well, you should—well, there is different. There 

are five different ways that you can test. You can test for quality 

standards. That is not going to help you. You can test for a specific 

pathogen. You are going to miss some and it is going to get out 

there, and then consumer confidence is going to be eroded again. 

Mr.STUPAK. Sure. 

Dr.BRACKETT. So you want to have a series of barriers. You want 

to have prevention. You want to have preventative controls to 

eliminate them. You want to have the testing to make sure that 

those are working. 

Mr.STUPAK. And whose responsibility should that be? The government or the manufacturers of this? 

Dr.BRACKETT. That should be the manufacturers. We are responsible for the product. 

Mr.STUPAK. Would you agree with the Science Board when they 

recently testified before the committee that the FDA does not have 

the capacity to ensure the safety of the food for our Nation? 

Dr.BRACKETT. Well, let me just state for the record also that 

being an employee of GMA now I can’t really respond from the 

FDA’s side. What I can say is that the FDA’s comprised of some 

of the most talented people I have ever worked with, and they have 

every bit of ability to do something. If you have more than one 

something at a time, and that is where the races are done, they 

spend probably more time than they need to responding to things, 

rather than being able to plan ahead and build a system that they 

would like to build. 

Mr.STUPAK. Right. So Science Board says they don’t have the capacity to protect our Nation’s food supply. Do you agree with that 

or not? 

Dr.BRACKETT. Again, they have the ability to protect one event, 

or maybe two, but when you build—or protecting is not the same. 

Mr.STUPAK. Do they have the ability to be pro-active? 

Dr.BRACKETT. They have the knowledge and the ability. They 

don’t have the resources to do that. 

Mr.STUPAK. I asked Mr. DeLorenzo about the Wall Street Journal article and FDA’s proposal went nowhere. Did you present that 

to the secretary of Health and Human Services at the time in your 

role as FDA? 

Dr.BRACKETT. Yes, I did, and in fact that was a proposal. That 

was at a time when we noticed the number of outbreaks of produce 

related illnesses going up. And it was an informational meeting. 

We went and presented this to the Department of Health and 

Human Services and provided several different options that could 

be done, one of which was mandatory standards. We also made 

sure that we—— 

Mr.STUPAK. So what happened to mandatory—why did mandatory standards get turned down? 

177 

Dr.BRACKETT. Well, it wasn’t turned down. That was not a decision making meeting. It was really to lay out before HHS what the 

problem is, what some of the solutions might be, and then that is 

the point at which—— 

Mr.STUPAK. Well, did you expect HHS to get back with you then 

with the options that were laid out at that meeting? 

Dr.BRACKETT. At some point, yes, 

Mr.STUPAK. Have they ever responded? HHS ever respond back? 

Dr.BRACKETT. Well, there was never a response back for that. 

What happened in the intervening time is we had other outbreaks 

that occurred. In the meantime we had melamene, we had all of 

the other things—— 

Mr.STUPAK. Well, wouldn’t all these other outbreaks then reinforce your request to the secretary of HHS that you have some 

mandatory standards if you are having more and more outbreaks? 

As the problem was growing wouldn’t you go with your strongest 

recommendation as opposed to not? 

Dr.BRACKETT. Well, I think at that point that was something 

that we needed to enter in the discussion. We had no idea exactly 

what that meant to our regulation, other than the fact that there 

had to be some baseline level of mandatory protection for our 

produce. 

Mr.STUPAK. Was the implementation of $76 million to implement 

this program over three years? Was that one of the reasons why 

it was rejected? 

Dr.BRACKETT. Well, it wasn’t rejected. We presented it before 

them. And I asked our staff when we prepared that plan to put a 

budget and a timeframe together so that decision makers would 

know what it would take to do it right and what resources would 

be required in a timely way. 

Mr.STUPAK. Let me ask you this. We are talking about regulations here. The Food Safety Inspection Service has announced 

plans to change its policy in identifying co-signees in a food recall, 

but the rule seems to have become bogged down in the bureaucracy 

at the United States Department of Agriculture and the OMB. Is 

the industry, Grocery Manufacturers, fighting the rule and what 

are the merits and problems with telling customers that they may 

have potentially dangerous food on their shelves? 

Dr.BRACKETT. Well, I have to be honest I am not familiar with 

that whole issue. A lot of that happened before I came to GMA, so 

I am going to have to defer on that. 

Mr.STUPAK. OK. Is there someone in your organization who could 

comment on that? 

Dr.BRACKETT. There would be, but I am not sure who the best 

person is. I can get that information to you, Mr. Chairman. 

Mr.STUPAK. OK. Well, let me ask you one more. A statement by 

Mr. Eisenberg bothered some of us on the committee. He told us 

in his testimony that twice during 2005 he met with the senior 

FDA staff. The second time with Margaret Glavin, Associate Commissioner for Regulatory Affairs, to complain the FDA was not adequately enforcing its pesticide residue requirements on snow peas 

imported from Guatemala. You are familiar with that? 

Dr.BRACKETT. I—yes. 

178 

Mr.STUPAK. OK. The testimony goes on to say I presented the 

data for 25 samples that they had taken at a retailer in the greater 

Miami area during 2004 and analyzed with 13 being violative of 

FDA standards. I pleaded with the FDA to take more surveillance 

swabs and then to place violative shippers on the import alert status as they had done in prior years. Even though the FDA had 

found a high percentage of violations itself the result of my pleading was FDA reduced by 50 percent the number of surveillance 

samples analyzed. Does this represent the FDA sort of surrendering in the war against unsafe food imports from other countries? 

Dr.BRACKETT. No, I don’t think it represents surrendering. I 

think it really represents a prioritization under limited resources. 

Again, having the right amount of resources to both food safety as 

well as pesticide analysis. And again, what I said, making sure 

that we put some plans in place to make sure that we can document what is being done in other countries to make sure that those 

pesticides are not applied. But again, it ultimately comes down— 

and I am not sure why Ms. Glavin made that decision. But it probably had to do with fact, what are you going to do with your resources? Are you going to spend it on something that is immediately public health significance or something that is a violation, 

a technical violation, of the regulation? 

Mr.STUPAK. Should the FDA—and I am asking you because you 

were there for quite awhile. Should the FDA be encouraged to 

apply strict liability standards to food processing operations? Specially should executives be criminally prosecuted for repeated failures to supply food free of contamination to their customers? 

Dr.BRACKETT. No, I don’t think that that is going to make the 

food supply any safer at all. As was stated earlier by some of the 

others it is really bad business for companies to be involved in outbreaks. If, unless of course, the person has knowingly and wantonly 

allowed a product to go out in—— 

Mr.STUPAK. Well, what about those cattle today? Downer cows? 

So far two people who were at that plant have been charged. The 

people working in the yards, but no one higher up is taking any 

responsibility for this. 

Dr.BRACKETT. Well, not being familiar with the USDA side, but 

I really can’t comment other than that they violated the law and 

legal action was taken. 

Mr.STUPAK. OK. I can go a little longer if you want me too. OK. 

I think that should probably conclude this panel for now. I don’t 

see any other members present. But I should also note for the 

record that during our hearing today FDA sent out yet another recall notice on imported fish products that may be contaminated 

with botulism spores. So we have yet another recall to add to our 

charts. 

And with that I will dismiss this panel. Thank you very much 

all of you for being here. Some of you even promised us some information. We look forward to seeing it as we will continue our hearings on food and drug safety. With that I will dismiss this panel. 

Thank you all for being here. 

I want to thank all of our witnesses for coming today and for 

their testimony. I asked unanimous consent that the hearing record 

will remain open for 30 days for additional questions for the record. 

179 

Without objection the record will remain open. I ask unanimous 

consent that the contents of our document binder on the desk there 

be entered in the record. Without objection the documents will be 

entered in the record. 

That concludes our hearing. Without objection this meeting of 

the subcommittee is adjourned. 

[Whereupon, at 4:30 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

STATEMENT OF HON. GENE GREEN

Mr. Chairman, thank you for holding this hearing today on food contamination 

in the private sector. I think it is important that we continue to have these hearings 

to address the issue food contamination in the US. 

Each year in the US there are approximately 76 million cases of foodborne illness 

and in the past year there have been numerous high profile food product recalls involving meat, fish, and vegetables. 

This committee has held numerous hearings on the issue of contaminated food 

and the safety of our food. These hearings have continuously highlighted the fact 

that the FDA and industry need to do more to make sure our food is safe to eat. 

While the hearing today focuses on incidents in private sector and industry responsibility, I want to point out that the FDA needs to improve their food inspection 

system. I believe that many of the outbreaks that have recently occurred can be directly linked to a poor inspection system. 

During these hearings on food safety, I have spoken many times of the need for 

more FDA inspectors at our ports. I represent the Port of Houston and I actually 

spent one day on the docks as they unloaded cargo and saw how the products are 

inspected. 

It is clear to me that the FDA does not have enough inspectors to inspect the food 

and products that are entering our country. 

If the FDA needs to hire third party inspectors or partner with another agency 

like the Department of Agriculture, then the FDA should do so to ensure product 

safety. 

It is our responsibility to make sure that the FDA has the resources it needs to 

protect us from contaminated food products. We can’t point out the problem without 

offering some solution as well. 

If we need to provide more funding to allow the FDA to do its job then we should 

do just that. Consumers should be able to purchase food without having to worry 

about botulism, E. coli, salmonella, or pesticides in their food. 

I want to thank our witnesses for appearing before the committee today and 

thank you Mr. Chairman for holding this hearing. I yield back my time. 

180 


49369.004
181 


49369.005
182 


49369.006
183 


49369.080
184 


49369.081
185 


49369.082
186 


49369.083
187 


49369.084
188 


49369.085
189 


49369.086
190 


49369.087
191 


49369.088
192 


49369.089
193 


49369.090
194 


49369.091
195 


49369.092
196 


49369.093
197 


49369.094
198 


49369.095
199 


49369.096
200 


49369.097
201 


49369.098
202 


49369.099
203 


49369.100
204 


49369.101
205 


49369.102
206 


49369.103
207 


49369.104
208 


49369.105
209 


49369.106
210 


49369.107
211 


49369.108
212 


49369.109
213 


49369.110
214 


49369.111
215 


49369.112
216 


49369.113
217 


49369.114
218 


49369.115
219 


49369.116
220 


49369.117
221 


49369.118
222 


49369.119
223 


49369.120
224 


49369.121
225 


49369.122
226 


49369.123
227 


49369.124
228 


49369.125
229 


49369.126
230 


49369.127
231 


49369.128
232 


49369.129
233 


49369.130
234 


49369.131
235 


49369.132
236 


49369.133
237 


49369.134
238 


49369.135
239 


49369.136
240 


49369.137
241 


49369.138
242 


49369.139
243 


49369.140
244 


49369.141
245 


49369.142
246 


49369.143
247 


49369.144
248 


49369.145
249 


49369.146
250 


49369.147
251 


49369.148
252 


49369.149
253 


49369.150
254 


49369.151
255 


49369.152
256 


49369.153
257 


49369.154
258 


49369.155
259 


49369.156
260 


49369.157
261 


49369.158
262 


49369.159
263 


49369.160
264 


49369.161
265 


49369.162
266 


49369.163
267 


49369.164
268 


49369.165
269 


49369.166
270 


49369.167
271 


49369.168
272 


49369.169
273 


49369.170
274 


49369.171
275 


49369.172
276 


49369.173
277 


49369.174
278 


49369.175
279 


49369.176
280 


49369.177
281 


49369.178
282 


49369.179
283 


49369.180
284 


49369.181
285 


49369.182
286 


49369.183
287 


49369.184
288 


49369.185
289 


49369.186
290 


49369.187
291 


49369.188
292 


49369.189
293 


49369.190
294 


49369.191
295 


49369.192
296 


49369.193
297 


49369.194
298 


49369.195
299 


49369.196
300 


49369.197
301 


49369.198
302 


49369.199
303 


49369.200
304 


49369.201
305 


49369.202
306 


49369.203
307 


49369.204
308 


49369.205
309 


49369.206
310 


49369.207
311 


49369.208
312 


49369.209
313 


49369.210
314 


49369.211
315 


49369.212
316 


49369.213
317 


49369.214
318 


49369.215
319 


49369.216
320 


49369.217
321 


49369.218
322 


49369.219
323 


49369.220
324 


49369.221
325 


49369.222
326 


49369.223
327 


49369.224
328 


49369.225
329 


49369.226
330 


49369.227
331 


49369.228
332 


49369.229
333 


49369.230
334 


49369.231
335 


49369.232
336 


49369.233
337 


49369.234
338 


49369.235
339 


49369.236
340 


49369.237
341 


49369.238
342 


49369.239
343 


49369.240
344 


49369.241
345 


49369.242
346 


49369.243
347 


49369.244
348 


49369.245
349 


49369.246
350 


49369.247
351 


49369.248
352 


49369.249
353 


49369.250
354 


49369.251
355 


49369.252
356 


49369.253
357 


49369.254
358 


49369.255
359 


49369.256
360 


49369.257
361 


49369.258
362 


49369.259
363 


49369.260
364 


49369.261
365 


49369.262
366 


49369.263
367 


49369.264
368 


49369.265
369 


49369.266
370 


49369.267
371 


49369.268
372 


49369.269
373 


49369.270
374 


49369.271
375 


49369.272
376 


49369.273
377 


49369.274
378 

Æ 


49369.275