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

67–100 2011

HOW DO WE FIX OUR AILING FOOD SAFETY 

SYSTEM? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

MARCH 11, 2009 

Serial No. 111–12 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


rfrederick on DSK6VPTVN1PROD with HEARING
COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

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 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

PARKER GRIFFITH, Alabama 

ROBERT E. LATTA, Ohio 

(II) 


rfrederick on DSK6VPTVN1PROD with HEARING
(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JAN SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


rfrederick on DSK6VPTVN1PROD with HEARING

rfrederick on DSK6VPTVN1PROD with HEARING
(V) 

C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Nathan Deal, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 7 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 7 

Prepared statement .......................................................................................... 10 

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

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

Hon. Donna M. Christensen, a Representative in Congress from the Virgin 

Islands, opening statement ................................................................................. 13 

Hon. Phil Gingrey, a Representative in Congress from Georgia, opening statement ...................................................................................................................... 13 

Hon. John P. Sarbanes, a Representative in Congress from Maryland, opening 

statement .............................................................................................................. 14 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 14 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 15 

Hon. John Barrow, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 17 

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

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

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 19 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

opening statement ................................................................................................ 19 

Hon. Betty Sutton, a Representative in Congress from the State of Ohio, 

opening statement ................................................................................................ 20 

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

prepared statement .............................................................................................. 21 

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

Texas, prepared statement .................................................................................. 24 

Hon. Eliot L. Engel, a Representative in Congress from the State of New 

York, opening statement ...................................................................................... 26 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, opening statement .................................................................................... 26 

WITNESSES

Caroline Smith Dewaal, Food Safety Director, Center for Science in the Public 

Interest .................................................................................................................. 27 

Prepared statement .......................................................................................... 30 

William Hubbard, Advisor, Alliance for a Stronger FDA, Former Associate 

Commissioner for Policy and Planning, Food and Drug Administration ........ 39 

Prepared statement .......................................................................................... 41 

Martin Cole, Ph.D., Research Professor of Biology and Director, National 

Center for Food Safety and Technology, Illinois Institute of Technology ....... 56 

Prepared statement .......................................................................................... 59 

Thomas E. Stenzel, President and CEO, United Fresh Produce Association ..... 70 

Prepared statement .......................................................................................... 73 

Jim Lugg, Consultant, Chiquita Brands, Former Executive Vice President, 

Food Safety and Quality, Fresh Express ........................................................... 89 

Prepared statement .......................................................................................... 91 


rfrederick on DSK6VPTVN1PROD with HEARING
Page

VI 

SUBMITTED MATERIAL

Article entitled, ‘‘Food Problems Elude Private Inspectors,’’ New York Times, 

March 5, 2009, submitted by Ms. Eshoo ............................................................ 119 


rfrederick on DSK6VPTVN1PROD with HEARING
(1) 

HOW DO WE FIX OUR AILING FOOD SAFETY 

SYSTEM? 

WEDNESDAY, MARCH 11, 2009 

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

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

2123 of the Rayburn House Office Building, Hon. Frank Pallone Jr. 

(chairman) presiding. 

Members present: Representatives Pallone, Dingell, Eshoo, 

Engel, Green, DeGette, Schakowsky, Gonzalez, Barrow, 

Christensen, Castor, Sarbanes, Space, Sutton, Waxman (ex officio), 

Stupak, Deal, Shimkus, Buyer, Pitts, Murphy, Blackburn, Gingrey, 

and Barton (ex officio). 

Staff present: Phil Barnett, Staff Director; Karen Nelson, Deputy 

Staff Director for Health; Karen Lightfoot, Communications Director; Rachel Sher, Counsel; Steve Cha, Professional Staff Member; 

Virgil Miller, Legislative Assistant; Jennifer Berenholz, Deputy 

Clerk; Lindsay Vidal, Press Assistant; Alli Corr, Special Assistant; 

Alvin Banks, Special Assistant; Caitlin Sanders, Staff Assistant; 

Clay Alspach, Counsel; Ryan Long, Counsel; and Chad Grant, Legislative Analyst. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR. 

Mr. PALLONE. The subcommittee is called to order. Today the 

subcommittee is meeting to discuss the topic of food safety. Unfortunately, news of unsafe food products has continued to make 

front-page headlines. The outbreak of E. coli in spinach a few years 

ago, the outbreak of salmonella in peppers this past summer, and 

the most recent outbreak of salmonella in peanut butter all emphasize that now is the time for us to act. Nine people have died as 

a result of this most recent peanut butter outbreak, and hundreds 

more have gotten sick. And millions of dollars have been lost in 

sales due to products being recalled. 

Food safety, or perhaps more accurately the lack thereof, continues to be one of my top priorities. In every Congress for the last 

12 years, I have introduced food safety legislation that aims to bolster the FDA’s enforcement and regulatory authority over the food 

industry. 

This year, I have collaborated with my colleagues Mr. Dingell 

and Mr. Stupak to introduce a comprehensive FDA reform bill. 

Many of the food provisions within the FDA Globalization Act built 

upon concepts and provisions I have put forth in my previous bills, 


rfrederick on DSK6VPTVN1PROD with HEARING
2 

and they emphasize prevention and shifting the responsibility of 

safe food from the FDA to the manufacturers. 

What it all comes down to is that it is not the government’s duty 

to make food safe. The companies, in my opinion, should be responsible for the products they make and must be held accountable for 

that responsibility. It is their job to make their food safe and to implement a plan that will ensure that they achieve that goal. 

It is the government’s job, on the other hand, to set standards 

for food safety and hold the food industry accountable for meeting 

those standards through regulatory and enforcement authorities. 

We must empower the FDA with those authorities so that the 

agency can effectively prevent problems from ever occurring rather 

than simply reacting when something bad has happened. And we 

must also require manufacturers to put in place the food safety 

plans to ensure that their products and production lines are safe. 

But there are other mechanisms aside from food safety plans 

that companies can implement to ensure the safety of their products. And we will hear testimony this morning from industry experts on the various safety mechanisms companies can implement 

in order to product their product lines and keep our Nation’s food 

supply safe. 

We will also hear about some of the regulatory authorities that 

the FDA needs in order to ensure that companies are actually implementing and following these preventative mechanisms. 

And finally we will hear from witnesses about the enforcement 

tools the FDA needs to fulfill its mission of protecting the public 

health and protecting Americans from harmful products both in the 

United States and abroad. 

I am looking forward to the discussion today and the information 

we will glean. We do want to pass food safety legislation rather 

quickly this year if we can, and so obviously today’s hearing will 

be very helpful in that regard. 

And I do want to mention—I don’t see him—but Congressman 

Stupak has done an excellent job in the O&I Subcommittee in 

bringing attention to this issue over the last, actually over the last 

3 years. He and I and Congressman Dingell have this legislation, 

but he has repeatedly had hearings addressing some of the concerns that have led to the legislation. 

[The prepared statement of Mr. Pallone follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
3 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 9 here 67100A.001
4 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 10 here 67100A.002
5 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 11 here 67100A.003
6 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 12 here 67100A.004
7 

Mr. PALLONE. And I now recognize my colleague, Mr. Deal. 

OPENING STATEMENT OF HON. NATHAN DEAL 

Mr. DEAL. I want to thank the Chairman Pallone for holding this 

hearing as we evaluate concepts that we as policymakers should 

consider in approaching reform of the Nation’s food supply as a 

food safety issue at the Food and Drug Administration. I appreciate 

the timeliness of this hearing, particularly since my home state of 

Georgia has itself been under a lot of attention as a consequence 

of a rogue peanut processing operation in the state, as you indicated, contributed to nine deaths and several hundred Americans 

being sickened all across our country. 

But let me be clear. I support giving FDA the resources it needs 

to ensure our Nation’s food supply remains safe and reliable for 

American dinner tables across the country. I believe a modernized 

approach to risk identification and prevention, particularly through 

hazard analysis and critical control point plans and similar prevention-minded procedures is a realistic and evidence-based solution to 

mitigating the hazards in the Nation’s food supply chain. 

We must focus on pursuing reforms with public safety protection 

as a top priority. However, we must do so diligently and methodically to ensure our actions do not cripple small businesses in the 

food industry across the country. 

Our Nation’s food supply needs a great deal of improvement in 

terms of the safeguards and fallback measures expected of a 21st 

century food supply chain in the United States. Recognizing the 

need for a risk-based approach to food safety reform, I have joined 

Representatives Jim Costa and Adam Putnam in cosponsoring H.R. 

1332, The Safe Food Enforcement Assessment Standards and Targeting Act of 2009, Safe FEAST Act as it is referred to. This act 

takes an aggressive yet realistic effort to improve food safety by 

granting FDA enhanced statutory authority to do its job as well as 

require implementation of safety measures to prevent food-borne 

problems before they even manifest themselves. 

It is my hope that any legislation that we pass out of this committee is similar to the provisions contained in H.R. 1332. I look 

forward to continuing to work with my colleagues on both sides of 

the aisle as we look at concepts that are aimed to improve the safety of America’s food supply. Thank you for holding this hearing 

today. I look forward to the testimony of our witnesses, and I welcome them to this hearing today. Thank you. I yield back my time. 

Mr. PALLONE. Thank you, Mr. Deal. Next is Chairman Waxman. 

I forgot to mention the work that you did on your previous committee on government oversight on the food safety issues as well. 

Thank you. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN 

Mr. WAXMAN. Thank you very much, Mr. Chairman. America 

does not need another deadly outbreak to understand that our food 

safety system is in desperate straits. We have ample proof of that. 

This is a bad situation not just for the American public but for the 

food industry itself. We must act now to address the problem, and 

this hearing today is the first step on that legislative path. 


rfrederick on DSK6VPTVN1PROD with HEARING
8 

Today we will hear about some of the major concepts that our 

witnesses believe must be included in a model food safety bill. The 

FDA Globalization Act of 2009 provides an ideal starting point, and 

I commend Chairman Emeritus Dingell, Chairman Pallone, Chairman Stupak for their work on this bill. Using this bill as a foundation, this committee will work with the President’s FDA to implement some commonsense food safety measures that are long overdue. 

As we move forward, we will also draw upon the work of Chairman Stupak and Ranking Member Walden who lead our subcommittee on Oversight and Investigations. It is clear we need to 

give FDA some basic authorities that will enable it to do its job. 

As the Oversight and Investigation hearing illustrated, FDA does 

not have the authority to routinely access records documenting the 

steps that manufacturers take to assure safety. FDA also lacks 

modern and flexible enforcement tools like administrative civil 

monetary penalties. It is our job to get FDA the resources and authorities it needs to get the job done and to do it well. 

But with over 300,000 registered food facilities throughout the 

U.S. and abroad, it is clear we can’t rely on FDA alone to prevent 

food-borne illness outbreaks. Manufacturers must implement preventive systems to stop outbreaks before they occur, and we need 

to hold them accountable when they fail. 

Dr. Stephen Sundlof, FDA’s director of food safety and applied 

nutrition, agreed at our hearing last month that each company in 

the chain of manufacturing has an obligation to ensure that the ingredients they are using as well as their final products are safe for 

Americans to consume. 

Related to this, I would like to announce now that next Thursday, on March 19, we will hold another investigative hearing that 

focuses on the companies that purchased these tainted peanuts and 

why their food safety systems failed to prevent these deaths and 

illnesses. 

We have a challenging job ahead of us, but we also have many 

reasons to be optimistic. In his budget, President Obama called for 

over $1 billion for FDA’s efforts to increase and improve inspections, domestic surveillance, laboratory capacity, and domestic response to prevent and control food-borne illnesses. 

I also know that President Obama is committed to naming an 

FDA commissioner soon, and I look forward to his announcement. 

The food safety crisis calls for strong leadership at that agency, and 

we need it now. 

Let me say a few words about the notion of a so-called single food 

agency. A lot of good points have been made about the need to improve our fragmented system and ensure that food safety is given 

appropriate attention by our regulatory agencies, but reorganizing 

large federal bureaucracies takes a great deal of time. And this is 

time we do not have when it comes to food safety. We have to act 

now. We have to concentrate the additional resources we can get 

at this point on the job at hand. 

Our first goal should be to address the problems that plague this 

program where it currently sits. After we finish that job, we can 

consider whether a reorganization is necessary, and if so, how to 

go about it. 


rfrederick on DSK6VPTVN1PROD with HEARING
9 

I look forward to hearing from our witnesses about what steps 

we can take to begin this process. Thank you, Mr. Chairman. Yield 

back my time. 

[The prepared statement of Mr. Waxman follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
10 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 16 here 67100A.005
11 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 17 here 67100A.006
12 

Mr. PALLONE. Thank you, Chairman Waxman. Our ranking 

member of the full committee, Mr. Barton. 

OPENING STATEMENT OF HON. JOE BARTON 

Mr. BARTON. Thank you, Chairman Pallone and Chairman Waxman. As we all know, there are differences between the political 

parties in Congress, but there are also many similarities. On food 

safety, there is no daylight between Henry Waxman and Joe Barton, between the Republican minority and the Democratic majority. 

We both agree it is important. We both agree we need to take a 

look at the problem in a serious fashion, and we both agree that 

if necessary we need to work together to move legislation to fix 

that problem. 

This committee in the last Congress through the Oversight and 

Investigation Subcommittee held nine hearings on food safety, and 

just this past month, as has already been mentioned, we held another hearing on the most recent food safety outbreak, the peanut 

butter salmonella outbreak. 

This committee and the various subcommittees have been active 

on food safety and we are going to continue to be active. The food 

safety debate in the past few years has centered on funding additional money for the Food and Drug Administration. Unfortunately, 

in my opinion, instead of asking the appropriators to give the FDA 

additional funding, some have wanted to raise the additional 

money through a pay-to-play fee on food companies. 

Last Congress, Nathan Deal of Georgia, ranking member on this 

subcommittee, and myself wrote the appropriators and asked them 

to give the FDA additional funds through the appropriation process. The appropriators responded positively, increased the appropriation for the FDA by $150 million in last year’s supplemental 

appropriation bill. 

We are the authorizing committee, and it is our job to give the 

FDA the authority to have the tools that it needs to make sure that 

our food is safe to eat. We must then get industry, consumers, the 

Food and Drug Administration, and the Congress together to 

strengthen the food safety system. 

Last week, I cosponsored the bipartisan Safe Food Enforcement 

Assessment Standards and Targeting Act. That takes up a page 

just the name of the thing. Which was introduced by Congressman 

Costa, Congressman Putnam, Congressman Deal, among others, 

because I think that it is the right approach to food safety. It takes 

a risk-based, prevention-based approach to fixing the problem. 

We need to focus on preventing food problems before they occur. 

One way the legislation I just enunciated does that is by requiring 

that companies create and properly execute food safety plans. Experts say that if the peanut corporation of America had had one, 

the salmonella outbreak never would have happened in the first 

place. The Costa Putnam bill also take a risk-based approach to 

food safety. It requires the FDA to focus the resources on high-risk 

facilities first where we get the most bang for our regulatory buck. 

Mr. Chairman, this is an issue that unites consumers and producers. Consumers want to be confident the food they eat is safe. 

Producers rely on that confidence because without it, their brand 

means nothing. In fact, it is a negative. There seems to also be a 


rfrederick on DSK6VPTVN1PROD with HEARING
13 

bipartisan and a bicameral support for moving food safety legislation. 

Again I say that on the Republican side, we stand united with 

our friends on the Democrat majority side. We want to outline the 

problems in hearings like the one we are having today. And if we 

need a legislative solution, we are prepared to cooperate in preparing that solution. Thank you, Chairman Pallone, again for holding this hearing. 

Mr. PALLONE. Thank you. Next is the gentleman from Texas, Mr. 

Gonzalez. Thank you. The gentlewoman from the Virgin Islands, 

Ms. Christensen. 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN 

Ms. CHRISTENSEN. Thank you, Mr. Chairman. Mr. Chairman, 

when the Subcommittee on Oversight met last month to take testimony on the salmonella outbreak, Chairman Pallone, you promised 

that you would hold this hearing. So I want to thank you and 

Ranking Member Deal for following up so quickly. 

In listening to the tragic stories of the families who were here 

that day and hearing the callousness of the peanut corporation executives from the emails that the subcommittee had uncovered, it 

was clear that there were gaping holes in the food safety system, 

which needed to be closed. 

In reviewing the testimony, several themes emerge with which I 

agree. One, the health and well being of the American public could 

not wait any longer for solutions to address our broken food safety 

system. Two, that the system must be completely overhauled in a 

manner that prioritizes coordination, resources, prevention, surveillance, accountability, transparence, and response and that empowers the FDA. And third, that we paid the price for our Nation’s broken food system, and we paid in human lives and health, direct 

and indirect economic costs in the way that citizens both here and 

abroad view products coming from the U.S. 

So I look forward to the testimony of our outstanding panel and 

to working to make bills like H.R. 759 law. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY 

Mr. GINGREY. Thank you, Mr. Chairman. Mr. Chairman, public 

health officials estimate that each year 76 million people become 

sick, 325,000 are hospitalized, and 5,000 die from food-borne illnesses caused by contamination. And of course, the most recent of 

these incidents in my home state of Georgia sickened more than 

677 people in 45 states and caused at least nine deaths due, in 

part, to a breakdown at FDA Oversight. 

We therefore have an important oversight and legislative role in 

ensuring confidence in the safety of our food supply. And I do commend the chairman for holding these hearings. While I am pleased 

to see this committee engaged on such a critical issue as food safety, we must avoid sending mixed signals. 

If we are trying to build a consensus that the FDA is overworked 

and lax on food safety oversight, adding things like tobacco to 

FDA’s responsibilities, I hope, will not take away from the very 


rfrederick on DSK6VPTVN1PROD with HEARING
14 

thing we are advocating here today. People understand the dangers 

of tobacco. There is no safe cigarette, but what they don’t understand and they don’t expect is a spinach salad or a scoop of peanut 

butter to kill them or their loved ones. 

So, Mr. Chairman, I hope that these hearings will help us reach 

a greater understanding of the breakdowns in the current system 

as well as the appropriate solutions to safeguard the health and 

the welfare of all Americans. And I do look forward to working 

with you in a bipartisan way. And I thank you, Mr. Chairman. I 

yield back. 

Mr. PALLONE. Thank you. The gentleman from Maryland, Mr. 

Sarbanes. 

OPENING STATEMENT OF HON. JOHN P. SARBANES 

Mr. SARBANES. Thank you, Mr. Chairman, for holding the hearing and for the work you have been doing on food safety and also 

want to salute Chairman Stupak, Chairman Waxman for their 

work as well as so many others who have been part of this effort. 

There are so many obvious negative consequences to not having 

good oversight of our food supply. Among them, of course, are when 

there is a severe contamination, which can lead to harm and to 

death, and we have seen that recently once again. 

A little less obvious is the low level contamination that can be 

broadly distributed across the food supply, but it is also certainly 

the province of those who are supposed to guard our food safety. 

The third that I am particularly intrigued with, and I have read 

some of the testimony and look forward to the witnesses today, is 

the effect that occurs when there is an outbreak and a crisis and 

alarm in the public that then causes people to turn away from 

healthy food, which, of course, undermines our overall objective of 

getting people to eat right in this country. So we have got to make 

sure we protect the food supply so that we can advance our overall 

goal. 

I look forward to the hearing today. Thank you. I yield back. 

Mr. PALLONE. Thank you. Mr. Pitts. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS 

Mr. PITTS. Thank you, Mr. Chairman. Like to thank you for convening this hearing on a topic that we read about in the newspapers every day, food safety. The ongoing salmonella outbreak 

linked to the consumption of products containing peanut ingredients from a single firm, Peanut Corporation of America, is only the 

latest in a string of high profile food safety related incidents. 

The U.S. food supply is widely regarded as among the safest in 

the world. Nonetheless, as we have just heard, public health officials estimate that each year 76 million people become sick, 

325,000 are hospitalized, and 5,000 people die from food-borne illnesses caused by contamination from any one of a number of microbial pathogens. 

Recent scares about spinach and peppers and peanut butter and 

other products, both imported and domestic, have lead to public 

confusion about which products are safe and whether the food 

items they have in their refrigerators and pantries could be contaminated. 


rfrederick on DSK6VPTVN1PROD with HEARING
15 

These instances have also lead to a lack of confidence among 

many Americans in the government’s ability to keep them and 

their families safe from food-borne illnesses. Our constituents must 

have confidence that when they go to their local grocery store or 

convenience store, the food they buy is safe and it has met the 

highest standards and safeguards of our food safety system. 

The U.S. food safety system, which includes as many as 15 different federal agencies collectively administering at least 30 different laws related to food safety must be modernized to meet the 

conditions of the 21st century. 

I look forward to hearing from our witnesses today, specifically 

on the role FDA plays in food safety on what must be done to prevent or mitigate future food-borne illnesses and outbreaks, what 

changes must be made to FDA’s current practices, and whether 

FDA’s current resources are adequate to accomplish these goals. 

And I would like to thank all of our witnesses for testifying 

today. I look forward to your statements. I yield back my time. 

Mr. PALLONE. Thank you, Chairman Dingell, and thank you for 

introducing this bill and all your efforts on this issue. 

OPENING STATEMENT OF HON. JOHN D. DINGELL 

Mr. DINGELL. Thank you, Mr. Chairman, and thank you for holding today’s hearing on the adequacy of our food safety system. 

I want to say that this is a most timely and necessary hearing 

because we have before us one of the finest messes in history. Everybody is busily blaming Food and Drug for the inadequacy of the 

protection of American consumers. The blame for that lies right 

here in the Congress and downtown in the executive branch because of the failure of the agencies in the federal government and 

this Congress to see to it that FDA has, first of all, a good and adequate basic fundamental statute on which they may work, and our 

failure to see to it that they have an adequate and reliable revenue 

stream to enable them to do what has to be done. 

Food safety is long a concern of mine, and today’s hearing is very 

timely and necessary. You have mentioned, and it has been mentioned already, that we have a fine piece of legislation before this 

committee, which I will mention later. We do, and its enactment 

could do much to resolve the problems at Food and Drug. 

There are not only problems with regard to food, but there are 

problems with regard to pharmaceuticals and devices. And there 

are severe problems in an uncooperative food processing industry 

that has done everything it can to obfuscate the matters and to see 

to it that we don’t get legislation. 

As you know, Mr. Stupak and his sister subcommittee has had 

some fine hearings, and he has brought folks in here to explain 

what is going on out there and to have Food and Drug tell us 

whether we have the resources. And we have had hell’s own time 

prying the truth out of them. 

We have a major problem on our hands relating to the safety of 

the food supply. It is killing Americans. The government accountability offices recognize this when they designated federal oversight 

of food safety as a high risk area for the first time in 2007. The 

Congress has done nothing about this except to talk and to come 


rfrederick on DSK6VPTVN1PROD with HEARING
16 

forward with a lot of wondrous plans like setting up a single agency to administer the business. 

Now, we have given them some more money, and that has been 

useful, but we have a lot more that has to be done. FDA is responsible for 80 percent of the food supply in the United States, but it 

is receiving only 24 percent of the expenditures. And I repeat, as 

a result of this, people are getting sick and dying. 

Every year, 76 million people contract a food-borne illness in the 

United States. About 325,000 of these require hospitalization, and 

about 5,000 die according to the Center for Disease Control. So we 

have that on our backs and upon our hands. 

More specifically, in the last two years, we can cite just a few 

events which have occurred. Melamine in infant formula and in 

milk products coming in from China. Nothing done to stop it. 

Tainted peppers from Mexico, harmful seafood and harmful fish 

from China, E. coli in spinach. That is just a little, and every year 

we get new information about the Food and Drug’s inability to protect the American people. 

Unfortunately the theme of a failed food supply system has not 

receded. We currently find ourselves in the middle of what is possibly the largest food recall in history, and it is costing billions of 

dollars to consumers and to innocent food processors because Food 

and Drug could not and did not do its job. And we have had hearings, by the way, on that which read like a joke book. 

We currently find ourselves with FDA wrestling with a foodborne illness outbreak associated with salmonella which has been 

found in peanut products produced by the Peanut Corporation of 

America, PCA. And because of the outright negligence of this company, more than 2,100 products from ice cream to dog food have 

been recalled. And by the Department of Agriculture can investigate and can inspect dog food manufacturers every year. Food 

and Drug can’t do the same thing for food processors for human 

beings. 

Because of the outright negligence of this company then, more 

than 680 people in 46 states have been sickened, and so far, we 

know of nine who have died from these events. And I think we can 

assume, given the way things have been going, that this is not yet 

over. 

What we have found in this instance and in many others is that 

FDA funding is woefully inadequate and their authorities are outdated. They have proven to be incapable of protecting our food supply. I commend the President for recognizing the inadequacy of 

FDA’s resources and for proposing increased funding for food safety 

activities in his budget package. 

However, my experience in the Congress has shown me that the 

only way to adequately address the problem of resources is by ensuring a steady predictable revenue stream for FDA. I propose to 

do this by establish a registration fee for manufacturers so that we 

can look and see what is coming into this company. 

And I would note to you because of Food and Drug’s inability to 

address this problem that we are finding controlled substances are 

coming into this country right alongside of other commodities 

uninspected by Food and Drug or anybody else. 


rfrederick on DSK6VPTVN1PROD with HEARING
17 

This is the only way we can make sure that Food and Drug is 

able to carry out its responsibilities. In addition to the shortage of 

resources, we must address the issue of authorities. It is shameful 

that FDA does not have authority to mandate recalls, to require 

manufacturers to identify and develop plans to mitigate hazards 

before they occur rather than after people are sick and die. And to 

identify safety questions by having full access to safety records 

without delay and to appropriately trace the ability and not only 

their own ability, but the origin of tainted products. 

Mr. Chairman, you and I, along with Chairman Stupak, have an 

appropriate safety solution to our food problems, H.R. 759, and I 

urge and invite our colleagues to join us in this particular undertaking. As a result of the failure to have Food and Drug given the 

authority it needs and the resources, people, I repeat, are dying. 

The Congress is working to address a mess left behind by another industry that has been left to self-regulate. I refer to the 

banks and the securities industry. And there, they are destituting 

people all across the United States in all kinds of ways from their 

401(k)s to their retirements to their saving account and to their 

hopes of the future and their homes and their mortgages. 

I look forward to our witnesses’ testimony today. I apologize for 

taking so much time, but I hope that this process will shake some 

folks up so that we will get some progress that we need in making 

the American people safe. I thank you, and I commend you, Mr. 

Chairman. 

Mr. PALLONE. Thank you. The gentleman from Illinois, Mr. 

Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman, and I will be brief. I 

want to thank the Chairman Emeritus. He is passionate about this. 

I see my friend Bart Stupak here, and I got to serve on ONI, had 

numerous of these hearings. We know the need, and we know we 

need to move rapidly. 

I have always been supportive of a risk-based approach in making sure that the money that is needed goes to where it is needed. 

And I think we need to focus on that. There are a lot of preventive 

aspects that we can do like irradiation in a lot of those areas that 

doesn’t affect food quality. I think we identified that, and we ought 

to help and incentivize movement in that direction. And funding is 

always going to be an issue. Make sure we fund appropriately so 

the money is going to where it is needed. 

That is why I am excited about being back on this committee. 

Mr. Chairman, I think serving with Bart has helped me get up to 

speed on this issue, and I look forward to being helpful. I yield 

back. 

Mr. PALLONE. Thank you. The gentleman from Georgia, Mr. Barrow. 

OPENING STATEMENT OF HON. JOHN BARROW 

Mr. BARROW. Thank you, Mr. Chairman, and thank you for keeping your promise to stay on this issue until we get something done 

about it. I can add nothing to the comprehensive statement of the 

Chairman Emeritus. But as befits my diminutive stature in the 

picture, I will focus on something smaller. 


rfrederick on DSK6VPTVN1PROD with HEARING
18 

I know that colleagues of mine are working on more comprehensive legislation from subjects like increasing the resources and increasing the amount of FDA inspections to creating a system of 

traceability to creating mandatory recall authority. There are a 

whole bunch of major elements that need to be put in place. 

I want to focus on something that I think ought to be a part of 

any comprehensive bill or can stand alone as a genuine contribution to this. And that is a measure to increase the effectiveness of 

both the sampling and the testing that is done of food. What we 

need in this country is a system that doesn’t give manufacturers 

the option of knowing what they need to know and when they need 

to know it, but requires them to know what they need to know 

when they need to know it, and that provides real-time information, reporting that information at the very same time to an effective regulator of the public interest so that the public knows what 

we need to know when we need to know it. 

I think that would go a long way toward cleaning up what is broken in this system, but we cannot continue to rely on a system that 

is essentially the honor system that allows folks to use the American people as a population of lab rats to test the food on them first 

to find out what is wrong with it. That won’t work. We have to be 

proactive about it, and that is what I hope the witnesses will be 

able to share with us about today. Thank you, Mr. Chairman. I 

yield back. 

Mr. PALLONE. Thank you. The gentlewoman from Tennessee, 

Mrs. Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN 

Mrs. BLACKBURN. Thank you, Mr. Chairman, and welcome to our 

witnesses. We are ready to hear from you today, and I have just 

a couple of thoughts to add to the comments that have been made. 

The hearings on food safety are not new. I will also say that as we 

have worked through this process over the last several years, one 

of the things that we have repeatedly asked you all for is clarification on your internal communications. How you communicate with 

one agency, one division knowing what work is being done in another one. It seems as if you continually have stumbles that do 

harm to the work that you are trying to do. 

Also, best practices. You seem reticent to talk about best practices and how you address some of the problems that face you all 

with food safety and with other parts. We know that you have to 

change the way you deal with quality control, that that is something for the suppliers as well as for you all internally. And we 

know that you need a reformed review system, that you also need 

some organizational changes to take place. 

Now, with the Chairman Emeritus in his remarks, which we all 

agree with much of that. I will differ on one point. I think before 

you start spending more money, what you need to do is show how 

you are going to reorganize and how you are going to address the 

problems that are before us. 

And thank you, and I yield back. 

Mr. PALLONE. Thank you. The gentlewoman from Colorado, Ms. 

DeGette. 


rfrederick on DSK6VPTVN1PROD with HEARING
19 

OPENING STATEMENT OF HON. DIANA DEGETTE 

Ms. DEGETTE. Thank you very much, Mr. Chairman, and I want 

to thank my compadre, Bart Stupak, for all the work we have been 

doing in ONI over the last 10 years on these food safety issues. I 

think that the bill that the chairman and the Chairman Emeritus 

and Mr. Stupak introduced is excellent, especially since it includes 

several issues I have been working on for many years, which is 

mandatory recall authority for the FDA and also traceability because we had the ability to do mandatory recall right now. 

Most people think we have it, and if we had had it, perhaps some 

of those people in this latest peanut butter outbreak would not 

have died because the FDA would have been able to recall that 

peanut butter sooner. 

Two things I will say. The first thing is I think we need to improve the traceability provisions in the bill, and I look forward to 

working with the chairman on that. The technology exists, and 

there is no reason we shouldn’t be doing it. 

The second thing is, as well as more resources, we need to give 

the FDA more authority to obtain the information that they need 

through subpoena authority and other kinds of authority. 

And finally, I agree completely with Chairman Waxman when he 

says that we need to do all of this now, and then after we do it, 

we need to look at structural changes in the way we oversee our 

food safety in this country. Congresswoman DeLauro and I have 

worked for many years on a unity food safety agency, but that will 

take time. And time is certainly something we don’t have right 

now, given what is happening with all these outbreaks. Thank you, 

Mr. Chairman. 

Mr. PALLONE. Thank you. The gentlewoman from Florida, Ms. 

Castor. 

OPENING STATEMENT OF HON. KATHY CASTOR 

Ms. CASTOR. Thank you, Mr. Chairman, and I want to thank my 

colleague, Mr. Stupak, as well. Food safety is vital to the health of 

all Americans. And many of you know, the Government Accountability Office keeps a very short list of major government problems 

that require significant reform. It is called the high risk series, and 

it includes notorious governmental failures such as the Financial 

Regulatory System, maintenance of our roads and bridges. Food 

safety also is on this high-risk list, and reform is vital. 

Let me give you one example. Tomatoes from my home state of 

Florida last year were blamed for a nationwide salmonella outbreak that was eventually traced to jalapeno and Serrano peppers 

from Mexico. In the meantime, the FDA’s warning not to consume 

tomatoes from Florida cost tomato producers at least $100 million. 

All of the time and effort spent warning consumers about Florida 

tomatoes only served to delay the solution to the real problem and 

allow more Americans to get sick. 

We have to address a lack of resources, the labyrinth regulatory 

regime, the lack of federal authority. The problems facing the food 

safety and oversight are legion, and they are difficult, but they are 

not insurmountable. So I look forward to the witnesses’ thoughtful 

recommendations today. Thank you. 

Mr. PALLONE. Thank you. The gentleman from Ohio, Mr. Space. 


rfrederick on DSK6VPTVN1PROD with HEARING
20 

Mr. SPACE. Thank you, Mr. Chairman. In yielding back, I would 

just like to thank you and Chairman Stupak and Chairman Dingell 

for your good work in this area. I look forward to the testimony. 

Mr. PALLONE. Thank you. The gentlewoman from Ohio, Ms. Sutton. 

OPENING STATEMENT OF HON. BETTY SUTTON 

Ms. SUTTON. Thank you, Mr. Chairman, for having this hearing 

and, you know, it was only a month ago today that under the tremendous leadership of Chairman Stupak that we had a hearing in 

the Oversight Subcommittee on the recent salmonella outbreak associated with peanut products. And at that hearing, I told the tragic story of an elderly woman from my district who died of salmonella poisoning. 

Sadly, Mr. Chairman, since then, another elderly woman from 

northeast Ohio by the name of Nellie Napier has died from salmonella. In fact, her death was announced that day. There have 

been over 99 cases of salmonella reported in Ohio and 680 nationwide. 

Now, I know, Mr. Chairman, that you and others have long been 

working to fix our broken food safety system, and I thank you. I 

thank Chairman Waxman and Chairman Emeritus Dingell and 

Ms. DeGette and others. 

The bottom line, Mr. Chairman, is that Congress needs to act 

quickly and comprehensively to address the food safety in our country. It is clear that the FDA does not have the current authority 

or capacity to properly oversee the safety of our food supply. That 

is why I reintroduced the Protect Consumers Act, to give FDA 

mandatory recall authority. It is a very simple measure. Certainly 

should be part of a comprehensive overhaul, but frankly I would 

love to see it moved quickly in its own right if we cannot move the 

comprehensive bill as quickly as we would like. 

We cannot sit back and let any more people become ill from food 

they eat. I look forward to hearing from our panelists today and 

working with my colleagues to fix our broken food system, and I 

yield back. 

Mr. PALLONE. Thank you. The gentleman from New York, Mr. 

Engel. 

Mr. ENGEL. Mr. Chairman, I would like unanimous consent to 

have Mr. Green’s remarks entered into the record. 

Mr. PALLONE. Without objection, so ordered. 

[The prepared statement of Mr. Green follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
21 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 28 here 67100A.007
22 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 29 here 67100A.008
23 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 30 here 67100A.009
24 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 31 here 67100A.010
25 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 32 here 67100A.011
26 

OPENING STATEMENT OF HON. ELIOT L. ENGEL 

Mr. ENGEL. Thank you, Mr. Chairman. Thank you for holding 

this important hearing today. If there is any good that may come 

of the Peanut Corporation of America salmonella crisis, it is now 

more clearly than ever that our food safety system is broken and 

in need of critical reforms. 

An AP poll last year found that 46 percent of people were scared 

that they would get sick from tainted food, and there is a reason 

for this fear: U.S. food-borne illnesses result in 76 million illnesses, 

hundreds of thousands of hospitalizations, and up to 5,000 deaths 

each year. 

As one of our witnesses astutely pointed out in his testimony, our 

Nation is sustaining deaths equivalent to those that perished in 

the World Trade Center attack in New York every six months. 

When you think about it in those terms, it just takes your breath 

away. And yet, we have set up the FDA to fail here. We expect the 

FDA to ensure the safety of our Nation’s food supply, but we 

haven’t given it the resources or authority to get the job done. 

Sure there are many food companies and facilities that are employing best practices to preserve their own food products, but unfortunately it is those that don’t that cause crippling problems for 

our public health and economy. This is why it is so important to 

grant FDA the ability to mandate clear preventative controls, 

strong traceability, and mandatory recalls within their food safety 

authority. 

Mr. Chairman, the costs are clear. I look forward to working with 

you on a comprehensive food safety reform bill this year. I yield 

back. 

Mr. PALLONE. Thank you. Gentlewoman from California, Ms. 

Eshoo. 

OPENING STATEMENT OF HON. ANNA G. ESHOO 

Ms. ESHOO. Thank you, Mr. Chairman, for holding this very important hearing on the issue of food safety, which is so needed. The 

American people should be able to trust their government to protect them from food-borne illnesses, and right now, to put it mildly, 

we are not even doing an adequate job. 

When people are dying or becoming seriously ill as a result of 

what they ingest in the United States of America that has always 

had the highest standards, we are really in trouble. And it is an 

area that most frankly the Congress has neglected for a long time. 

So I think that now is the time to address it because the FDA 

really should be the world’s premier food inspection authority. It is 

an issue that affects everyone. Doesn’t matter whether you are rich 

or poor, where you live in the country, whether you are a youngster 

or an oldster, God help you if you have ingested something that 

has not been reviewed. 

And we live in a global economy, and we have things pouring 

into our country, and unless it is inspected, then our citizens are 

placed at risk. I have cosponsored legislation that Congresswoman 

DeLauro has offered. I think it is a very good bill. I think that 

there are good ideas, both in this committee and from outside the 

committee. I think that the system has to obviously be modernized, 

and I really think that we should separate our food from the FDA. 


rfrederick on DSK6VPTVN1PROD with HEARING
27 

I think we should have a food safety administration. I, for one, 

am a little tired of running the FDA on user fees. I think we are 

doing it on the cheap, and as long as we do that, we are going to 

be plagued with the problems that we are here to discuss today. 

So I look forward to working with all of my colleagues on this 

issue. I don’t think anyone has a corner on the market of wisdom 

on it, but I do think that the committee should take into consideration all of the bills that are being introduced on this because there 

are very good ideas that are contained in each one. 

So thanks again, Mr. Chairman, and to the witnesses that are 

going to testify today, thank you. We know that you will be instructive. We will learn from you, and hopefully we will pay close attention to you. Thank you. 

Mr. PALLONE. Thank you. I think that concludes opening statements by the members. So we will now turn to our panel. I want 

to welcome you, and I ask you to come forward. We only have one 

panel today, but they are distinguished. And they are actually 

quite—let them sit down first. 

I will start on my left with Ms. Caroline Smith DeWaal, who is 

the food safety director for the Center for Science in the Public Interest, and she has been dealing and calling attention and been a 

watchdog on this issue for a number of years. Many of your ideas 

have been incorporated in my bill and then into the larger bill 

sponsored by Mr. Dingell and Mr. Stupak and myself. 

Mr. William Hubbard, who is former associate commissioner for 

policy and planning at the Food and Drug Administration and an 

advisor for the Alliance for a Stronger FDA. Good to see you again. 

Dr. Martin Cole, who is research professor of biology and director 

of the National Center for Food Safety and Technology at the Illinois Institute of Technology. 

Mr. Thomas Stenzel who is president and CEO of United Fresh 

Produce Association. 

And finally Jim Lugg who is former executive vice-president, 

Food Safety and Quality, Fresh Express, and consultant for 

Chiquita Brands. Thank you all for being here, and we have 5- 

minute opening statements, and we will start with Ms. DeWaal. 

STATEMENTS OF CAROLINE SMITH DEWAAL, FOOD SAFETY 

DIRECTOR, CENTER FOR SCIENCE IN THE PUBLIC INTEREST; WILLIAM HUBBARD, ADVISOR, ALLIANCE FOR A 

STRONGER FDA, FORMER ASSOCIATE COMMISSIONER FOR 

POLICY AND PLANNING, FOOD AND DRUG ADMINISTRATION; 

MARTIN COLE, PH.D., RESEARCH PROFESSOR OF BIOLOGY 

AND DIRECTOR, NATIONAL CENTER FOR FOOD SAFETY AND 

TECHNOLOGY, ILLINOIS INSTITUTE OF TECHNOLOGY; 

THOMAS E. STENZEL, PRESIDENT AND CEO, UNITED FRESH 

PRODUCE ASSOCIATION; AND JIM LUGG, CONSULTANT, 

CHIQUITA BRANDS, FORMER EXECUTIVE VICE PRESIDENT, 

FOOD SAFETY AND QUALITY, FRESH EXPRESS 

STATEMENT OF CAROLINE SMITH DEWAAL 

Ms. DEWAAL. Thank you very much, Chairman Pallone and also 

Chairman Deal for having this hearing. I do want to recognize just 

the tremendous food safety leadership that is in this room from 


rfrederick on DSK6VPTVN1PROD with HEARING
28 

you, Chairman Pallone, to former Chairman Dingell, Mr. Stupak, 

and Representatives DeGette and Eshoo. You have all been tremendous leaders, and we are thankful to be hopefully at this point 

of having legislation poised to really address these problems. 

I am the director of food safety for the Center for Science in the 

Public Interest. And we represent over 900,000 consumers both in 

the U.S. and Canada. We are focused on food safety, nutrition and 

even alcohol issues. Pretty much anything you put in your mouth 

we worry about. 

The impact of the Peanut Corporation of America outbreak and 

recall are still reverberating through the food supply. It has caused 

nearly 700 confirmed illnesses and nine deaths and the recall of 

over 3,200 separate products. Despite its size and scope, this event 

is neither rare nor unexpected. Congress has held nearly 20 hearings in the last two years focused on similar failures of FDA’s food 

program linked to everything from spinach tainted with E. coli, pet 

food containing an intentionally added melamine, which sickened 

and killed many, many animals, and even a previous peanut butter 

salmonella outbreak, which was thoroughly investigated in this 

committee. 

These events are causing steep declines in consumer confidence, 

both in the overall safety of the food supply and in FDA’s ability 

to protect the public. Nearly half of those questioned by Consumers 

Union in November said their confidence in food safety had declined. 

Also last fall, a poll conducted by Ipsos-McClatchy reported that 

28 percent of those polled believe food safety had gotten worse, and 

46 gave food safety controls a failing grade. In July 2008, in the 

midst of the salmonella outbreak linked first to tomatoes and then 

to peppers, an Associated Press-Ipsos poll found that 46 percent of 

people were worried that they might get sick from eating tainted 

products. Clearly it is time for Congress to take action to fundamentally reform and fully fund our food safety system. 

I will now outline a couple of the essential elements that CSPI 

thinks need to be in any legislation moving forward to begin the 

process of reforming FDA’s food safety program. 

The heart of any effective reform effort lies in prevention, not response. Legislation should include at least the following three components for preventing food safety problems at food processors. 

First, Congress should require every food plant regulated by FDA 

to have a food safety plan detailing that it has analyzed its operations, identified potential hazards, and is taking steps to minimize 

or prevent contamination. These requirements are already in place 

for all meat and poultry processors today but not in plants regulated by FDA. 

Legislation should set risk-based inspection frequencies for food 

plants and establish clear auditing parameters when states are 

conducting inspections on behalf of the federal government. 

And finally specific authority should allow the agency to set testing frequencies and require food processors to report adverse reports to government inspectors. Without these checks on the 

plants, companies can follow the practices of PCA, which instead 

of fixing its salmonella problems, it fixed the tests. 


rfrederick on DSK6VPTVN1PROD with HEARING
29 

Consumer concerns extend up and down the food chain from the 

farm to the table. So legislation also needs to provide on-farm food 

safety plans that will give farmers tools to manage risks like raw 

manure, unsafe water, and worker hygiene. 

Imported foods also pose special challenges as they enter the 

U.S. from all over the world including many countries where they 

are essentially unregulated. CSPI supports the use of certification 

systems operated by foreign governments and some third parties if 

they are subject to appropriate oversight by FDA. Certifiers of imported product can give FDA boots on the ground and greatly increase the agency’s capacity to enforce our food safety requirements 

among the foreign facilities from 175 different countries that export 

to the U.S. 

President Barack Obama has promised a government that works. 

These new authorities, together with increased funding will certainly help FDA improve. But to deal with the root of the problem, 

Congress and the Obama administration will need to go beyond 

making a few improvements. Structural reforms are also essential. 

FDA is responsible for 80 percent of the food supply, and yet the 

commissioner’s attention is frequently on drugs, medical devices, 

and cosmetics, animal feed, many other issues that FDA regulates. 

Food issues frequently unfortunately fall to the bottom of the pile. 

Today there is no single expert in charge of the policies budget and 

enforcement staff and no credible voice communicating to the public and the industry what needs to be done to prevent outbreaks. 

It is time to elevate food monitoring functions within the Department of Health and Human Services. With both the public and the 

regulated industries clamoring for change, we are very happy to be 

here today and to have the tremendous leadership on this committee. Thank you. 

[The prepared statement of Ms. DeWaal follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
30 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 38 here 67100A.012
31 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 39 here 67100A.013
32 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 40 here 67100A.014
33 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 41 here 67100A.015
34 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 42 here 67100A.016
35 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 43 here 67100A.017
36 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 44 here 67100A.018
37 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 45 here 67100A.019
38 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 46 here 67100A.020
39 

Mr. PALLONE. Thank you. Mr. Hubbard. 

STATEMENT OF WILLIAM HUBBARD 

Mr. HUBBARD. Thank you, Mr. Chairman. I have a written statement for the record. I will just make a few brief remarks if I may. 

As you know, the public is confused and even frightened by what 

is going on. Imagine a fully loaded 737 crashing every other week. 

That is the type of toll we are talking about here, but yet we continue to tolerate the intolerable. And the public health costs have 

been mentioned by many of the members today, and they are very 

real. 

Suffering out there is very real, and also I don’t think we should 

disregard economy costs that companies and the health care system are being burdened by food-borne disease outbreaks that are 

largely preventable. So we are allowing things to happen that we 

can stop, and I would like to make two main points about the problem. 

First is the issue of FDA resources. I believe I have a slide if we 

could put it up, and I think really in a way it captures the problem 

that FDA has gone through. Do we have that slide? When I came 

to the FDA in the 1970s, there were 70,000 food processors in the 

United States. FDA had the resources to inspect 35,000 times a 

year, which meant everybody could get a visit every other year. 

There were very few imports at the time. 

[Slide.] 

As you can see from this slide, we are now doing about 6,000 or 

7,000 a year, but if you plotted the increase in the industry, that 

has gone from the 70,000 domestic firms at that period to 150,000 

today and another 216,000 farm firms. So we have gone from inspecting about 50 percent of the food supply at any time to five percent of the domestic processors and about two percent of all processors. And that has largely been a function of resources. FDA’s 

budget has been cut and cut and cut for 30 years, and we simply 

need to find a way to reverse that. 

And you can also plot, as those numbers go the direction they go, 

recalls have gone up. FDA’s adverse findings when they do do inspections have gone up, and you have a general lack of overall 

quality in many of these firms. 

I will say, however, as I say in my testimony, I think the food 

supply is generally safe. We have gaps though that are willing to 

cause the problem. Unless everybody does it right, no one can get 

it right. 

And then the other main point I wanted to make is authorities. 

FDA has authorities dated to 1906. It is essentially a relic of the 

19th century. It doesn’t work. It requires an inspector to perhaps 

catch a problem the day he happens to get there if he gets there 

at all. FDA needs the kind of preventive controls many of you have 

mentioned and Ms. DeWaal mentioned, in which they can require 

a firm to examine how they make their food and control hazards 

so the food never gets contaminated to begin with. 

And those are practices that the leading food firms use now, so 

we are not talking about imposing on the food industry some 

strange new regulatory regime. We are talking about adopting inVerDate Mar 15 2010 23:38 Feb 27, 2012 Jkt 067100 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 E:\HR\OC\A100.XXX A100

rfrederick on DSK6VPTVN1PROD with HEARING
40 

dustry-developed preventive control technology that has been proven to work. 

And then lastly there are some other provisions that I think are 

very important. Trace back has been mentioned. We saw with the 

tomatoes last year and the spinach earlier how these outbreaks 

drag on for weeks or even months because FDA doesn’t have adequate trace back authority. 

They need access to the records of these firms so they know 

where the food has come from and where it is going. They need 

mandatory recall authority. Clearly some firms simply stall for a 

few days, and during those few days while FDA is begging them 

to do a recall, the food is moving and being consumed. 

And we also need to accredit these labs that are doing a lot of 

the work because you need to know you have a high level of quality 

in the laboratories. 

There are some other things in my testimony; however, in the interest of time, I will stop there. But I certainly do urge you to act 

this year on food safety legislation. 

[The prepared statement of Mr. Hubbard follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
41 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 49 here 67100A.021
42 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 50 here 67100A.022
43 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 51 here 67100A.023
44 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 52 here 67100A.024
45 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 53 here 67100A.025
46 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 54 here 67100A.026
47 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 55 here 67100A.027
48 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 56 here 67100A.028
49 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 57 here 67100A.029
50 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 58 here 67100A.030
51 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 59 here 67100A.031
52 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 60 here 67100A.032
53 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 61 here 67100A.033
54 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 62 here 67100A.034
55 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 63 here 67100A.035
56 

Mr. PALLONE. Thank you. Dr. Cole. 

STATEMENT OF MARTIN COLE 

Mr. COLE. Chairman Pallone, Ranking Member Deal, good morning. I guess what I would like to try and do, I have written testimony. I would like to make a few remarks to try and help this committee wrestle with the complexities of the food safety systems and 

what approaches they should take. 

I really do applaud the important work and the urgency and the 

opening remarks that have been made this morning. Certainly we 

have seen, I think we are all acknowledging, the complexity of the 

supply chain. The food business is global now. Go to the supermarket, the products can be from anywhere in the world. Global 

sourcing of ingredients. 

Look at consumer trends now. You know we want people to eat 

healthy food. There is a trend toward more natural, fresher products, less preserved, more convenient products, longer shelf life. All 

of those, as a food microbiologist, they go against traditionally what 

you would like to see in the marketplace. So we want food to be 

healthy, but we want it to be safe. 

And we certainly need to, I think as the opening remarks have 

mentioned, we have new issues, and we need a new approach, OK. 

We need to have a modern food safety system here in the U.S. I 

think really in simple terms, I look at that in terms of four main 

components to a modern food safety system. 

First of all, risk-based preventative measures. You need programs to monitor progress. That can be trend analysis. That can 

be testing, inspection, even Epidemiology, but you need programs 

to be able to monitor progress. 

You need appropriate government oversight. Without government oversight, you get the issues that we have in peanut butter 

and salmonella. 

And then lastly you need a strong research program because 

things are changing so fast. If you don’t have a world class research program, you can’t deal with issues proactively and deal 

with them swiftly. 

Dealing with microorganisms—and I am a microbiologist by 

trade—dealing with microorganisms is even more complicated because they are alive, OK. So bacteria have the ability to grow and 

survive and adapt throughout the food chain. So when we are designing food safety systems, we need to be cognizant of the ability 

of bacteria to change and to grow and adapt. So that adds another 

complexity with what we are dealing with. 

Now, in response to these issues, I mean this is not just a U.S. 

issue. Internationally, the food safety community has responded by 

developing new tools, risk-based tools, to try and ensure the safety 

of the food supply. And it now possible through modeling and risk 

assessment to be able to link the level of hazard or the prevalence 

of a hazard in the food supply to the likely illness that it is likely 

to cause. And that has allowed us to develop new risk management 

frameworks that will provide for scientific underpinning to the develop or risk-management options, the science behind the frequency of inspections, et cetera. So these new developments we 

need to be using. 


rfrederick on DSK6VPTVN1PROD with HEARING
57 

It is ironic that, you know, in the U.S. much of these developments have been led by U.S. scientists, and yet we need to start 

walking the talk here. So we have done a good job, I think, in 

tracking sporadic cases of food-borne illness through new tools, food 

safety net, Wholesfield, del electrophoresis fingerprinting if you 

like, of organisms. But we are really falling behind in the prevention side, and that is really where we need to up our game. 

A quick word about oversight testing and inspection. I think the 

short answer is you can’t test and inspect safety into food. OK you 

need that oversight because without that, you get the PCA issue. 

But testing alone, think of the issue with salmonella where a very 

low infective dose can give you an illness. It is like looking for a 

needle in a haystack. The statistics of sampling are such that you 

can’t test safety into food. 

Think also of the volume of foods that are coming into the U.S. 

now. What is it? Over 60 percent of fresh produce, fruit and vegetables, coming to the U.S. from overseas, over 80 percent of seafood 

coming from overseas. You know we need to be practical about the 

percentage of foods we can realistically inspect. We need the inspection there as a deterrent, but we need to be smart about where 

we use those resources. And we need to use them where the highest risks are. 

Now, in industry, there are two main tools for really applying 

and implementing risk-based measures, and as was mentioned before, these are standards tools that have been adopted through 

Codex. The two main tools are good manufacturing practice, or 

GMP, and hazard analysis critical control point, or HACCP. And 

you can think of GMP as like the building blocks, the standard operating procedures for sanitary design, equipment, people, labeling, 

recall procedures, et cetera. 

Many of the recall issues that we see from FDA actually, if you 

look at whether GMP would deal with them or whether HACCP 

would, many of them actually would deal with GMP, and it is an 

oversight issue that we have. So we need to think about where we 

should be using GMP and also where we should be using HACCP. 

HACCP is a more systematic approach identifying, evaluating 

the food safety hazards. It is usually more quantitative in nature, 

usually defining a critical control point in the food chain that you 

must control to reduce, eliminate, and prevent hazards. Typically 

in a value chain, you would be looking at a performance standard 

for HACCP as well. 

Now, I also have one slide to share with the committee this 

morning. I could take that. I think it is a good lead in to some 

other testimony relating to fresh produce. You can go to slide three 

please. That is great. So really I think it kind of illustrates a good 

lead in to the next witness. If you look at the complexity of the supply chain for fresh produce, you can’t pasteurize lettuce, OK. You 

would have lettuce soup if you were to do that. 

OK, so there isn’t one kill step in the chain. So you have to take 

a through chain approach. You have to take good agricultural practice. You have to look at what you are doing in terms of washing 

of the produce, and you have to look at what you are doing in 

terms of the distribution. 


rfrederick on DSK6VPTVN1PROD with HEARING
58 

So I just wanted to share with you this is a complex business. 

There is research going on at the moment between industry and 

government to really try and come up with the risk management 

options that would build some robustness into the value chain for 

fresh produce. This is a category of food we want people to eat 

more of, OK. Hugely impactful in terms of nutrition, and yet we 

need to build more robustness in terms of safety. 

My final comment, Mr. Chairman, is around research. You know 

the U.S., I think, should be really at the forefront of research in 

terms of the safety and health of food. It is such an important driver of public health, but also very important in terms of trade for 

the U.S. With that, thank you very much. 

[The prepared statement of Mr. Cole follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
59 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 67 here 67100A.036
60 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 68 here 67100A.037
61 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 69 here 67100A.038
62 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 70 here 67100A.039
63 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 71 here 67100A.040
64 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 72 here 67100A.041
65 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 73 here 67100A.042
66 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 74 here 67100A.043
67 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 75 here 67100A.044
68 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 76 here 67100A.045
69 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 77 here 67100A.046
70 

Mr. PALLONE. Thank you, Dr. Cole. Mr. Stenzel. 

STATEMENT OF THOMAS STENZEL 

Mr. STENZEL. Thank you very much, Mr. Chairman. I don’t have 

a slide, but I will thank Dr. Cole for sharing on behalf of the fresh 

produce industry. And I will affiliate myself with his remarks. 

In my written testimony, I have provided a number of specific 

policy provisions that I will call to the committee’s attention, but 

I would like to spend just a few minutes this morning talking a bit 

more personally about some of these issues. 

First, I would encourage all of you to eat more fresh fruits and 

vegetables. At a time when Congress is debating health care reform, all public health authorities agree that one of the most important things we can do to improve health is to eat more fruits 

and vegetables. But achieving that goal is dependent upon the 

main issue that we are talking about today, and that is the critical 

challenge to modernize and reform food safety law. 

Now, I personally am confident in my produce choices today. We 

consume over a billion servings of fresh produce every day in the 

United States, over five million bags of salad every day. And out 

of the hundreds of different produce items in the supermarket, a 

very small number, only five, have been related to any type of foodborne disease in recent years in quantity. 

But we also know that we have issues. Consumers know it, and 

consumers are fearful of fresh produce at the moment. And that is 

something we have to address. Now, our industry has been working 

in this area for many, many years, but the spinach crisis almost 

three years ago now was a watershed moment for us. 

Remember the unprecedented national response. We pulled spinach off of the shelves of every grocery store in America for weeks. 

In fact, we now know the only contaminated product came from one 

farm through one processing plant on one day’s production, even 

one afternoon shift. It wasn’t even the whole day. There has been 

no contamination from that processing plant or from spinach in the 

last two and a half years. And yet today, spinach consumption is 

still down in the United States, one of the healthiest vegetables 

that we should all be consuming. 

Following that outbreak, we undertook a mission. First, to look 

at a comprehensive reevaluation of all our leafy greens production. 

Mr. Lugg will talk about that, and his leadership in that area of 

our industry has been tremendous. We looked at every possible 

step and have adopted the most rigorous good agricultural practices with strong compliance measures and audits, some conducted 

by the California Department of Food and Agriculture, but also 

other states and private sector auditors. 

But our industry also had to address the broader question of federal regulation. In January of 2007, our board of directors adopted 

a series of policy principles for mandatory federal oversight of our 

business. Let me explain the three principles briefly. 

First, we believe produce safety standards must allow for commodity specific food safety practices based on the best available 

science. In a highly diverse industry that is more aptly described 

as hundreds of little industries, one size clearly does not fit all. For 

example, food safety requirements applicable to products grown 


rfrederick on DSK6VPTVN1PROD with HEARING
71 

close to the ground would be very different from food safety practices for fruit grown on trees. 

Secondly, we believe produce safety standards must be consistent 

for any individual commodity wherever it was grown or processed 

anywhere in the United States or imported into the country. Consumers must have confidence that the same safety standards were 

applied no matter whether the produce is grown in California, New 

Jersey, or Mexico. 

Finally we believe achieving consistent produce safety standards 

across the industry does require strong federal government oversight and responsibility. That is going to take credibility for consumers, and it is also going to create equity for producers across 

all of our industry. The FDA must determine the most appropriate 

nationwide safety standards in an open and transparent process 

with full input from the states, industry, academia, consumer 

groups, and all stakeholders. 

Most of my testimony this morning has been about prevention. 

Preventive controls are where it is at. That is what we have to do. 

As Dr. Cole said, we are not going to test food safety into our products. But I do have to take just one moment to talk about outbreak 

investigations as well. 

When I testified before the ONI subcommittee last summer in 

the midst of the jalapeno outbreak, I raised several issues that 

were critical, and I think the peanut paste fiasco of the last several 

months continues to reinforce those. It is clear that no one is in 

charge of these outbreak investigations. There is no chain of command. There is no command and control procedure, and American 

consumers and industry alike are left to be whipsawed back and 

forth from momentary change to change. 

Crisis planning is not done in advance. It seems to be learned on 

the job. The government’s failure to use industry expertise, at least 

in our case, to help reduce and end the outbreak last summer was 

a tragedy. 

Now, let me say that this needs to be transparent. It has to be 

supported by consumer groups, and it has to be a squeaky clean 

system. But there is expertise in industry that can help reduce, 

moderate, and end outbreaks even in the tragic situations when 

they occur. And we have to find a way for CDC and FDA to take 

advantage of that expertise. 

Finally risk communication is critical. The principle of timely 

and rapid communication with the press and public cannot be underestimated. But it is also critical that any risk communication 

expert would advise precision and care in communicating exactly 

what needs to be said and not speculating. One single office at FDA 

needs to have the authority and accountability for public communications with one single officer designated as the media spokesperson. 

Let me conclude. There is a public health imperative that we 

consume more fresh produce. We as an industry are doing everything we possibly can to make sure that we are delivering safe and 

healthy products. But because science tells us there is no such 

thing as zero risk, government must also be able to assure the public that our food safety systems are based on the best available 


rfrederick on DSK6VPTVN1PROD with HEARING
72 

science and are enforced by strong and appropriate oversight. 

Thank you. 

[The prepared statement of Mr. Stenzel follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
73 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 81 here 67100A.047
74 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 82 here 67100A.048
75 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 83 here 67100A.049
76 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 84 here 67100A.050
77 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 85 here 67100A.051
78 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 86 here 67100A.052
79 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 87 here 67100A.053
80 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 88 here 67100A.054
81 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 89 here 67100A.055
82 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 90 here 67100A.056
83 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 91 here 67100A.057
84 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 92 here 67100A.058
85 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 93 here 67100A.059
86 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 94 here 67100A.060
87 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 95 here 67100A.061
88 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 96 here 67100A.062
89 

Mr. PALLONE. Thank you, Mr. Stenzel. Mr. Lugg. 

STATEMENT OF JIM LUGG 

Mr. LUGG. Thank you, Mr. Chairman and members of the subcommittee. My name is Jim Lugg. I am former executive vice-president of food safety and quality at Fresh Express and today a consultant to Chiquita Brands International. 

The strategy or food safety plan is a requirement for any company that is in the food business. And it must be a solid one, and 

it must be adhered to. Regular reviews of that food safety plan are 

required so that we are constantly updating it for new risks that 

we have become aware of. 

In our business in Fresh Express, we have to look at really three 

areas. One is the production area. Second is harvesting, and third 

is processing. Each of those areas are unique unto themselves and 

require specialized plans. But these reviews that we do of these 

three areas are what help us identify risks and prevent contamination from occurring. 

More importantly, I think the overall lesson we have learned 

from these plans are that we have to do a very good job at focusing 

on preventive efforts. That means that in our case we have really 

four things that we look at: where are we planting the crop, what 

is the environment surrounding the crop along with its creatures, 

third, what kind of water will we use to irrigate with and then 

process it with, and finally, all along that supply chain we have the 

worker issue, worker hygiene. 

But again I stress the fact that even though we have a robust 

plan and we have been doing fresh cut lettuce since 1978, we constantly must update that plan so as we can identify new risks that 

we didn’t realize because of new science or whatever the case may 

be. 

But I can point out a simple case that you can all identify with, 

I think. If we have a lot of lettuce that we are ready to harvest 

and one of our people can identify what seems to be an animal incursion into that field of product, we have two choices. If we can 

clearly identify where the incursion occurred, we can avoid harvesting that product. If we can’t clearly identify that risk, we abandon the field completely. 

But I emphasize that this issue of risk evaluation is a never ending process in the food industry. And that is true whether it is 

fresh, whether it is frozen, or whether it is canned. Almost without 

fail, these risk evaluation lead to more effective preventive steps, 

and that is the bottom line. 

And I also would emphasize that these food safety plans, at least 

at our company where we handle a number of different vegetables, 

are not transferable. Lettuce is different from tomato, so they must 

be commodity specific. 

And then I want to go on and just mention that in our company 

when we do identify a risk, we focus intently on how to manage 

that risk and how to evaluate whether our management practices 

are safe. This requires a lot of record keeping, what has been measured, when it was measured, and all those sorts of details. But the 

important point I want to make is that once the risks are identiVerDate Mar 15 2010 23:38 Feb 27, 2012 Jkt 067100 PO 00000 Frm 00095 Fmt 6633 Sfmt 6633 E:\HR\OC\A100.XXX A100

rfrederick on DSK6VPTVN1PROD with HEARING
90 

fied, the preventive process controls must be put in place and then 

measured for their effectiveness. 

I also want to conclude actually by saying that we have a lot of 

tools that we can use to measure our effectiveness such as third 

party audits, testing, inspections, and so forth. And these tools are 

very effective in helping us evaluate how well we are doing. 

But the one thing I just want to give you a simple example of 

in closing is an acre of spinach has more or less three million 

plants in it. The typical practice for sampling a spinach field to 

measure, see if a pathogen is present, is to collect something less 

than 100 plants from that acre of three million plants. You can calculate for yourself how challenging the odds are of finding a pathogen in that sort of a regime. 

Finally and just to summarize, I believe the FDA should insist 

on every food company having a very current food safety plan. Secondly, the FDA should satisfy itself that regular risk evaluations 

are being done. Third, FDA should have access to preventive action 

steps that have been taken to manage the risk. And finally, my 

message is it is all about prevention. Thank you. 

[The prepared statement of Mr. Lugg follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
91 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 99 here 67100A.063
92 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 100 here 67100A.064
93 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 101 here 67100A.065
94 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 102 here 67100A.066
95 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 103 here 67100A.067
96 

Mr. PALLONE. Thank you, Mr. Lugg, and thanks to all the panel. 

We will have 5 minutes questions from each member who desires, 

and I will start with myself. 

I wanted to ask Dr. Cole. You explained the difference between 

the hazard analysis and critical control points or HACCP and good 

manufacturing processes. But I am not sure I understand how that 

relates to many of the bills that are now—you know, they are calling them preventive safety plans which you flashed up in your 

chart or preventive controls. 

Just describe to me a little better maybe the differences between 

the HACCP and many of the bills, the language in the bills preventive safety plans or preventive controls if you could a little better. 

I know you flashed one of those up, but I don’t necessarily understand the difference. 

I understand that the GMPs are like the basic fundamentals 

but—— 

Mr. COLE. Yes, I think the best way to think about it is the term 

preventative food safety plan is a broad term which could include 

a whole range of different preventative measures. The way that 

those preventative measures could be implemented within industry 

and then inspected are things like GMP which is the, as you said, 

are the basic kind of building blocks. You can’t do HACCP unless 

you have the building blocks in place, unless you have the basic 

sanitary conditions in place. 

Mr. PALLONE. But then these preventative control systems can 

vary widely. So if that is the case, is it sufficient to just require 

that all manufacturers or producers simply have a food safety plan 

in place, or do we have to—if it has to be a need for FDA to have 

ability to be more specific than that? 

Mr. COLE. I think the trick there is, because even with the additional resources, there is always going to be finite kind of resources 

we can bring to bear on a public health burden. So we have to be 

smart about the way that we apply these tools. And so we have to 

use either GMP or HACCP or both appropriately to the hazard that 

we are trying to control and the risk that we are trying to manage. 

So, you know, let us take a fresh produce example. I think the 

comments from one of the testimonies here relating the products— 

is it product specific. If we were to look at the safety of potatoes, 

OK. Potatoes usually end up being cooked and prepared, and we 

are not really that concerned about the safety of potatoes. 

Mr. PALLONE. So it is going to vary from product to product? 

Mr. COLE. It is going to vary depending on the level of risk that 

we are trying to control, yes. 

Mr. PALLONE. Now, let me go to Ms. DeWaal then. I mean you 

can comment on this as well, but if there was a system of mandatory preventive controls in place prior to the PCA outbreak, would 

that have helped to prevent it from ever occurring in the first 

place? And if you want to comment on what Dr. Cole mentioned. 

Ms. DEWAAL. Well, thank you, and I do agree with Dr. Cole that 

the preventive control plan covers your underlying GMPs, sanitation plans, as well as your HACCP plan if you have one, and your 

testing. 

The key element for the PCA recall and outbreak is that the 

company, because of the absence of a plan and the records to supVerDate Mar 15 2010 23:38 Feb 27, 2012 Jkt 067100 PO 00000 Frm 00102 Fmt 6633 Sfmt 6633 E:\HR\OC\A100.XXX A100

rfrederick on DSK6VPTVN1PROD with HEARING
97 

port that plan, they were not compelled during the inspections to 

actually show what they knew to the inspectors, which meant that 

when the State of Georgia went in and did inspections, they were 

just doing a spot check. Conditions on that day were what they 

could inspect. If a bill passes that contains this kind of requirement, when an inspector arrives, they will not only to get to inspect 

the plants and the products that are there, they will be able to go 

back and look through the records. And hopefully in that case, they 

would have found and acted on the causative salmonella test result 

findings that PCA had. 

Mr. PALLONE. Because they basically have a plan in place about 

what they have to check for is what you are saying? 

Ms. DEWAAL. That is right. It gives the inspectors the access to 

the information on food safety that the plant itself maintains, 

which today FDA doesn’t have it and the states don’t have it. 

Mr. PALLONE. Well, just give me a little more. Maybe, Mr. 

Stenzel, you know, talk about how a plan might be different, you 

know, like tomatoes versus spinach. And are there certain things 

that you would require, you know, for both versus things that 

would be different? 

Mr. STENZEL. There are. You are seeing the full chain here in 

this panel discussion. We actually start at the farm level with good 

agricultural practices, which are kind of the GMPs of the farm 

level I might say. That is the basics that all farms should be following. There are also then commodity specific standards and practices that we believe are appropriate, we have called for FDA to implement. Particularly for those products that have been associated 

with a pathogen in the past, even rarely. So for tomatoes, there 

would be different sets of standards and practices, commodity-specific guidelines. 

Today that exists. The industry has worked hard in different sectors, tomato industry, the leafy greens. In fact, we have done a 

pretty good job, but we need FDA to be the holder of that standard 

so that it is applied across the industry and is not left just to individuals to follow it on our own. 

Mr. PALLONE. OK, thank you. Mr. Deal. 

Mr. DEAL. I think there seems to be general agreement that a 

food safety plan needs to be in place, and they will vary depending 

on what level of production you are in. Mr. Lugg, though, if we do 

make these plans mandatory and FDA comes in to inspect, in your 

opinion, what records should be disclosed to the FDA inspector in 

terms of those safety plans? 

Mr. LUGG. We would really like to have happen is when the 

plans are being developed, we would like to have FDA input along 

with our own so that the plan has all of the steps that the FDA 

would like to see included in it so that when the inspector arrives, 

he has been a part of that architecture, and he can easily see what 

he wants to see. 

Mr. DEAL. So he would, by having access to the plan, know what 

they have done from a preventive standpoint? 

Mr. LUGG. Exactly. I think the owner of the food needs to own 

the food safety plan, but certainly there are very good advisors 

within CFSAN, for example, that can assist in making that plan 

even better. 


rfrederick on DSK6VPTVN1PROD with HEARING
98 

Mr. DEAL. Let us go to the next step on this in a logical sequence, and any of you that would like to respond, please do so. 

The next logical step is what do you do with regard to laboratory 

testing? Now, I would imagine that many firms have internal labs 

that do internal testing, and they would, of course, I presume, 

maintain records of their own internal testing. Others would rely 

on external labs to provide testing and test results back for them. 

The one big question that I still have is to what extent do we require those lab tests to be disclosed to FDA? 

And the reason I have some concern about it is that you may 

have tests being done for a variety of different reasons. One might 

be someone who is going to process a product, but they want to find 

out what the status of the raw product is. Let us say peanuts for 

example. In its raw stage, they may get a result that may have 

some salmonella contamination. 

But if they are intending to follow through with the kill cycle, 

then obviously that should eliminate that particular problem. My 

concern is that I don’t think we ought to necessarily overburden 

FDA with every lab report given under every circumstance and for 

every purpose. 

So how do we differentiate what lab report should be disclosed? 

And do you have any thoughts on that? 

Mr. HUBBARD. I will take a shot at that if I may. The FDA’s concern is that if you require these lab tests to be routinely submitted, 

people may just stop doing them. 

Mr. DEAL. That is right. 

Mr. HUBBARD. Firms often do them as part of their quality control process at the end to make sure that their systems are working. I think the state of Georgia was considering legislation that 

would require notification. But the theory is if you require it and 

the firm just stops doing the lab testing, you have not improved 

things. 

Mr. DEAL. Right. 

Mr. HUBBARD. But it would be important if FDA finds a connected problem, say, in a PCA example, is in their inspection and 

says to them do you have any laboratory findings that would help 

us understand if you are the source of the problem. And if they say 

yes, then, of course, FDA should be able to access those records. 

Mr. DEAL. So you are saying then that should be a part of the 

maintain records subject to inspection when the FDA inspector 

comes in, not that the lab, upon receiving a negative or positive, 

as the case may be, report that the lab has to directly report at 

that point to FDA. 

Mr. HUBBARD. I understand that that is the FDA position, yes. 

Mr. DEAL. OK. All right, anybody else want to comment on that? 

Ms. DeWaal. 

Ms. DEWAAL. Thank you. I just want to note that today most of 

the bills that you are looking at do have some lab reporting, but 

the different bills are different in their strengths. And we really 

want to get, first of all, this access that Mr. Hubbard is talking 

about. Any time an inspection is done, the inspectors should be 

able to see the full range of what the plant is looking at. 

But there are times, for example, where, if testing is compulsory 

for an industry or where there is some kind of public health alert, 


rfrederick on DSK6VPTVN1PROD with HEARING
99 

that you might want to compel some kind of reporting to the agency. So I think you need to leave the door open in some of those circumstances for testing direct reporting. But the reporting really 

should go from the plant to the agency, not necessarily from the 

lab. 

Mr. DEAL. Dr. Cole. 

Mr. COLE. Yes, I think that is a pretty good answer. Again it 

comes back to based on risk. So if we are looking at the testing results as part of an ongoing food safety plan, I think the agency 

should have access to those records as part of that. They should 

have access as to what follow-up actions were taken as a result of 

those results. And then for certain products, you might want to 

make it compulsory that a positive salmonella, for example, is a notified situation. If I am making infant formula, for example, and I 

get a positive salmonella, that should be a notifiable instance, and 

that should go directly to the agency. 

So again unfortunately the devil is in the detail with the risk, 

managing the risk versus the resources. 

Mr. DEAL. Well, just a quick comment. That is where we need 

your help, in fleshing out the devil because we can get the broad 

principles. I think it is the fleshing out of that I would appreciate 

hearing from you if you have any further thoughts about how we 

do that. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Deal. Mr. Gonzalez is next. 

Mr. GONZALEZ. Thank you very much, Mr. Chairman. First question, and I need to get the pronunciation. Is it Ms. DeWaal? Is that 

correct? 

Ms. DEWAAL. DeWaal, that is correct. 

Mr. GONZALEZ. DeWaal. Thank you. We have DeWaals in San 

Antonio that came from Minnesota, but they spell their name a little different, but it is DeWaal. 

Page three of your written testimony, ‘‘the absence of federal inspection, inadequate state inspection have let problems at PCA fester.’’ No matter how much we, I guess, empower the FDA, it is just 

going to be overwhelming. We are never going to have all of the 

assets and resources truly because of just the expanse of the issues. 

And we are going to have to form partnerships obviously with state 

authorities and, of course, private enterprise. 

With the Peanut Corporation of America, my understanding is 

that they had an operation in Texas. You are probably very familiar. It may have been Georgia-based, but we had peanut butter, a 

lot of it obviously out of the state of Texas. 

Mr. DEAL. Virginia-based. 

Mr. GONZALEZ. It is Virginia-based? Well, then we are a subsidiary and happy to have been a subsidiary. But the question 

comes down to is that they did have private testing. And I am just 

wondering. I don’t know what we have out there now as far as certification of the labs that are actually hired. The question always 

is that the closeness of the relationship generally will lead to whatever conclusion the person that is requesting the testing. 

Do you have concerns about that particular aspect going forward? 

Ms. DEWAAL. Yes, I think it is critically important that the legislation should contain a lab accreditation provision. Now, that won’t 


rfrederick on DSK6VPTVN1PROD with HEARING
100 

apply to every in-house lab that a company may have. But lab accreditation will raise the confidence that both inspectors at the 

state level, federal level, can have in the results of those tests. 

But getting to your question on the complexity and how will FDA 

actually manage its job, I mean they have a huge job of regulating 

both the domestic industry and the imports. And the reality is the 

agency has been starved for resources. There are certainly management structures that could work that would allow for FDA to have 

very consistent programs working with the states to do inspection, 

but I don’t believe those programs have been designed at the agency. 

And unfortunately the public is really losing confidence in the 

ability of this agency to do those tasks. So it is important to get 

the funding in place, to get the new legislation and these new authorities in place where there is common agreement on so much of 

this. 

But I am not sure that even with those elements we are going 

to be able to restore consumer confidence in the functioning of this 

agency. So I was very glad today to hear Chairman Waxman say 

that the question of structure, which was also raised by Representative Eshoo, would be one that they would leave open for further 

consideration because it is very important that consumers trust the 

agency to manage this huge responsibility. 

Mr. GONZALEZ. And I think the authors of the bills recognize 

that, and we are going to be moving forward, and hopefully we will 

do as complete a job as possible under the circumstances and the 

competing bills. 

This is going to be to Mr. Stenzel and Mr. Lugg. And that is 

what really establishes accountability? In my view, it is liability. 

Not that this may have an application, one concern I have is that 

the FDA is, in essence, not just the floor of the standard of care 

but represents the standard, which we all agree today is totally inadequate in form and in practice. 

And yet many people will look to that as what would govern the 

behavior of individuals out there in this particular chain as we say 

from the farm to the retailer. Do you all have any views on the liability of individuals out there and how important that aspect in 

this whole, what I say, the accountability established by liability? 

Mr. STENZEL. Mr. Gonzalez, you raise an important point. I think 

the chairman mentioned it in the beginning. It is the responsibility 

of food companies and food purveyors to ensure that we have safe 

foods. It is government’s responsibility, we believe, to make sure 

that there is a system of oversight and integrity and set the standards that we have to comply with. But ultimately that liability on 

the individual food company is a pretty darn important motivator. 

Look at PCA, you know, for the example of when you do something 

wrong, I think they were called a rogue operator, Mr. Deal, look 

at what that penalty is going to be. 

I would also like to comment on your earlier question if I may 

about partnerships particularly on farm. This is very important. 

We don’t anticipate a reality of FDA hiring 3,000 inspectors to go 

across farms in the United States or abroad. The partnership there 

we would recommend is with USDA who knows agriculture in the 


rfrederick on DSK6VPTVN1PROD with HEARING
101 

United States, knows it abroad as well, in partnership with state 

departments of agriculture. 

FDA needs to set the public health standard. That is for the integrity and confidence. But then in terms of actual outreach education auditing on farm, a strong partnership with Agriculture 

would make sense. 

Mr. GONZALEZ. And Mr. Lugg, I apologize but my time is up. And 

I yield back to the chairman. 

Mr. PALLONE. Thank you. The gentleman from Illinois, Mr. 

Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. I want to start with 

Mr. Lugg, and like the comments that were just addressed by my 

colleague from Texas, I understand that the heavy hand of a liability process will also punish the bad actors, and it is in the best interest of everyone to have a safe and efficient operation. 

Mr. Lugg, is it safe to say that sometimes the inspections conducted by you all are maybe more specific than you might get from 

an FDA inspection? 

Mr. LUGG. Yes, our inspections particularly with respect to good 

agricultural practices in the field are very detailed. 

Mr. SHIMKUS. Can you give us an example—— 

Mr. LUGG. Sure. 

Mr. SHIMKUS [continuing]. Of something that you may have spotted that FDA may not have? 

Mr. LUGG. Yes, in the agricultural production sector, which the 

FDA really doesn’t spend a lot of time with, we have our own staff 

that will go and select a piece of ground that we are going to plant 

on, and that piece of ground is chosen based on the environment 

that surrounds it, and the quality of the water that we could use 

to irrigate with. That is something that the FDA wouldn’t normally 

be concerned with. 

Now, we have a new group in California called the leafy greens 

marketing agreement, and they do get concerned with the good agricultural practices. But the FDA folks generally come into our 

manufacturing facilities. 

Mr. SHIMKUS. And I think, Mr. Stenzel, I think that is kind of 

your point you were making as far as having USDA deal kind of 

with the agricultural end of this process. I think a lot of us, depending upon the, you know, what your life experiences are. I used 

to be in the active military, and we feared the inspector general 

coming down. And the inspector general would have—we knew the 

list, right. We knew the standards, and by golly, by knowing they 

were coming down, it made us clean up. Really we want to be careful. I mean we really want to go after the bad actors. 

I mean we want to go after the people who would take a report, 

falsify the records, inspect them, and nail them versus those who 

have a proven track record of having—or, I think you testified once 

before or when we were doing the Oversight Investigation, if you 

talk about leafy greens. And if the processing facility has irradiation and salmonella is—you may want to inspect to make sure that 

the irradiation machine is working. But if that is killing salmonella, then you have addressed that need versus maybe the multitude of other things that you might have to do. 


rfrederick on DSK6VPTVN1PROD with HEARING
102 

Ms. DeWaal, I have talked about this because I really want to 

focus, and I have talked about the risk-based approach. And that 

talked about the food safety plan, but then identifying for particular crops. I mean you can have a generic system, but you do 

have to identify for the specific crop. But what about the debate of 

the inspection regime? If you have a successful manufacturing facility, has good manufacturing process, has a food safety plan, has 

historically been graded at 100 percent, A plus, super duper, five 

star quality. Do you think it is a good use of our resources to be 

in there twice a year versus—my issue is if they are a good actor, 

we ought to incentivize them. And we ought to take the time for 

the second investigation and go after the bad actors. Could you 

comment on that? 

Ms. DEWAAL. Certainly. The question of trying to create a riskbased inspection system but one that also gives the agency the 

flexibility to identify the best performers and spend less time and 

less resource there is one that we have really spent a lot of time 

looking at. I wish we were dealing with legislation that required 

six-month inspections. Most of the bills actually are looking at, you 

know, maybe one year, maybe two years, maybe four years, depending on the type of facility. So there is a broad range of inspection. 

But there is one bill that actually provides strict inspection, a 

risk-based inspection system, but then gives a lot of flexibility to 

FDA to set alternative inspection frequencies when plants show 

that they deserve it. And that type of language is contained in Representative DeLauro’s bill, the Food Safety Modernization Act. 

So the bills range from very general language also to very specific language. Her bill has more frequent inspection frequencies, 

and maybe, I don’t know how the committee would feel about the 

affordability of some of the inspection frequencies in the bill. But 

it is a very good model to look at it because it really defines what 

is risk-based inspection for the agency and then sets these alternative inspection frequencies based on criteria. 

Mr. PALLONE. Thank you. Ms. Christensen. 

Ms. CHRISTENSEN. Thank you, Mr. Chairman, and I want to 

thank the panelists for their testimonies and particular for their 

recommendations. 

Some of you have recommended a separate agency, and I will 

ask. Anyone can answer or all can answer. For those who think we 

should have a separate agency or for those who don’t, do you think 

it would be just as effective to have just a specific office under FDA 

with a single head? Would that equate well enough for you? 

Ms. DEWAAL. I think I will start this answer. You all are welcome to join in. We have looked at the question of a single agency 

ranging from a unified agency with all of meat and poultry inspection combined with all of FDA inspection to one that is more narrow. 

The approach that we are looking at right now is one which just 

separates out the food functions at FDA under a separate food 

standards administration, similar to what they have done in many 

European countries and in other developed countries around the 

world. 


rfrederick on DSK6VPTVN1PROD with HEARING
103 

The food standards agency would be headed by a food safety expert, and we don’t have that in place today at FDA. There is no 

line authority for food safety. The policy issues are handled at 

CFSAN, the Center for Food Safety and Applied Nutrition. The inspection force is managed by the Office of Regulatory Affairs. The 

budget comes out of the commissioner’s office. 

There is really no line authority here, and really there is no risk 

communicator. When something bad happens, I mean who is going 

to be on the call? Right now, we hear from CFSAN. We hear from 

ORA and CDC. So I think there is a structural problem that needs 

to be addressed at FDA. It is possible that you could have a deputy 

commissioner for food issues, for example, that might play that 

role, but it is very important to us that you have someone with direct line authority to the secretary of agriculture. 

Just looking at the sister food safety agency for a moment, at the 

U.S. Department of Agriculture, they did about 10 years ago pass 

a law that required food safety to be headed by an undersecretary 

of food safety, and that person does have direct line authority to 

the secretary of agriculture. 

So our concern about some kind of deputy commissioner model 

is that you would still have everything going through the commissioner who has just an incredibly large job for consumer protection 

today. 

Mr. HUBBARD. I will give it a shot too. I have spent some time 

over the years thinking about that. It may be necessary to do that 

at some point, but if we could wave a magic wand right now and 

create a single food agency, tomorrow nothing would be any different because you would still have an under-resourced, under-authorized agency that couldn’t solve these problems. So I think you 

are doing the right way which is fix the underlying problem. Then 

go back and see if the structure can work with that and be effective. And if it is not, then I think the next step would be to look 

at a single agency. 

Mr. STENZEL. If I may, I think I am going to agree with Caroline 

on this, that I do think that there is a fundamental problem in the 

lack of direct food authority within the agency at this point. So I 

would urge you to think about at least that narrow issue in the 

current food safety legislation. 

Whether is the equivalent of undersecretary of FSIS at USDA I 

think is a good one. We have to untangle food authority from everything else within FDA. 

Ms. CHRISTENSEN. Thank you. I came from the Committee on 

Homeland Security, and, of course, there as well, food security is 

also a major concern. And the way the system is today, I don’t have 

any degree of comfort that if the terrorists wanted to do something 

to our food system that they would have any problem. I was noting 

that then Secretary Tommy Thompson had raised that concern, 

and he remarked that he couldn’t understand why terrorists had 

not attacked our food supply because it was so easy to do. 

But your recommendations talks about preventing contamination 

at the production, at the storage and transportation lines. Do you 

feel that the recommendations that you are giving us around the 

food safety system now are adequate also for protecting from an attack either from a homegrown or outside terrorist? 


rfrederick on DSK6VPTVN1PROD with HEARING
104 

Mr. HUBBARD. Well, the principles are the same because you 

would analyze the risk and how easy it would be, say, to introduce 

a microbial agent into food and then have it, you know, be shipped 

around to a lot of different places and injure a lot of different people. So you still would be looking at well, how accessible is my facility? Might be as simple as making sure there is a security guard 

every night and the doors are locked. And of course, in other areas, 

it might need to be more sophisticated than that. 

Mr. PALLONE. Mr. Gingrey. 

Mr. GINGREY. Thank you, Mr. Chairman. A couple of weeks ago 

when we were having a hearing about the salmonella outbreak, unfortunately from the processing plant in my home state of Georgia 

down in southwest Georgia. The testimony told us that the labs, 

these private labs that the processing plant contracted with to 

check for salmonella, apparently there were several positive results, and then finally one negative. And you know the rest of that 

story. 

But the question I want to ask of the entire panel is what came 

up during that hearing. The fact that the labs were not required, 

maybe even prohibited, as I understood it, from sending that positive information to anybody else except from whence it came, from 

who they were contracted with to do the laboratory testing, and it 

just seemed to me that it would be fairly easy to get that information to the FDA. Computers allow us to do that. 

I would like to ask the entire panel in fact what your thoughts 

are in regard to these positive results from the private labs actually being required to submit those to the FDA. And we will start 

from my left, your right. 

Ms. DEWAAL. Thank you. The facts situation that was outlined 

in that committee hearing was just tragic, and I think the committee did a tremendous service to get those facts out. The mandatory requirement for labs to report would—it looks like an appealing solution because they are the ones doing the test. But we have 

real concerns that if you don’t couple any mandatory testing reporting with a requirement to test, then the result will be, as Mr. Hubbard said, that companies just won’t test. 

So you need to have in the legislation the ability for FDA to say 

for peanut processors, you might have to test for this pathogen or 

that indicator organism, and then determine when those test results would be appropriate. I do think that there are some pathogens—botulism is an example—where mandatory reporting by a 

lab might be appropriate. 

But I think the legislation should be clear that FDA has the authority to require companies to test. They should be able to test 

their test records when they inspect the plants, and that means 

anybody, the Agricultural Department of Georgia or the FDA. And 

then on certain pathogen combinations that, in fact, it would be 

open to mandatory testing either by the plant or by the lab. 

Mr. HUBBARD. Mr. Deal touched upon that earlier. Certainly it 

would be important if FDA went to a facility like PCA and was 

doing an inspection and identified PCA as a source of a problem, 

that they should be able to say as part of their inspection process 

have you done any lab testing? And if the answer is yes, could we 

see that so we could see what you knew and when you knew it? 


rfrederick on DSK6VPTVN1PROD with HEARING
105 

But to require all labs to automatically send information to the 

FDA could actually cause people to stop doing the testing, which 

would not be an outcome that I think most people would want. I 

think Ms. DeWaal sort of—— 

Mr. GINGREY. But as Ms. DeWaal said, FDA certainly could require in certain commodities at—— 

Mr. HUBBARD. In certain commodities. 

Mr. GINGREY [continuing]. Certain steps in the process—— 

Mr. HUBBARD. Yes. 

Mr. GINGREY [continuing]. That the testing be done for particular 

pathogens, and that could be a requirement. 

Mr. HUBBARD. And that might be necessary in some cases. That 

is right. 

Mr. COLE. I would agree with those comments. I think this is a 

situation where given, you know, this is not the first outbreak we 

have had with peanut butter. We had one two years ago. There 

have been outbreaks overseas. I think we should be viewing this 

product as a high-risk product. We should have a requirement to 

test and a requirement to report those tests. I think also we need 

to have preventative controls in place to prevent contamination. 

Once salmonella is in that product, it is very resistant, oK, to heat 

processing et cetera. So we need suppliers or companies buying 

that product too should have, you know, really done a better job 

in supplier assurance of that product rather than just looking at 

test results as well. 

Mr. STENZEL. I think we share a pretty common view on the 

panel, particularly the access to those test records is the most critical aspect. I share the same concern in terms of required every 

single test to be automatically forwarded to FDA. I am not sure 

that that is the most effective answer for a company that deliberately retested and retested until they found something they 

wanted. 

That is criminal behavior, and no matter what standard we 

would put in place, I am not sure we are going to prevent someone 

who does that. They would not send the results—— 

Mr. GINGREY. Yes, agreed. In that situation, it wouldn’t have 

made a difference. 

Mr. STENZEL. But the access to the records I think is absolutely 

critical. 

Mr. GINGREY. Thank you, Mr. Stenzel. Mr. Lugg? Your microphone is not on. 

Mr. LUGG. I am sorry. Because we are in the fresh business, and 

the difficulty we have in collecting a representative sample, we rely 

so heavily on prevention that we just have a lot of lab results from 

our agricultural fields. We do have a program of what we call intelligent testing, and we do share those results routinely with researchers and our California Department of Public Health. 

As far as a requirement to furnish test results, I think that 

might discourage people from actually getting tests done and might 

in the end result in not the result that you would like. 

Mr. PALLONE. We have to move on. Mr. Waxman. 

Mr. WAXMAN. Thank you, Mr. Chairman. I want to elaborate on 

some of the points Mr. Gonzalez raised. We have learned at numerous hearings the foods program at FDA has been starved for reVerDate Mar 15 2010 23:38 Feb 27, 2012 Jkt 067100 PO 00000 Frm 00111 Fmt 6633 Sfmt 6633 E:\HR\OC\A100.XXX A100

rfrederick on DSK6VPTVN1PROD with HEARING
106 

sources over the years and, Mr. Hubbard, in your testimony, you 

state there are currently 150,000 registered facilities in the U.S. 

And the charts you provided us today on the plummeting numbers 

of inspections in the U.S. paint a stark picture of the effects of this 

loss of resources, and that has a real impact on food safety. 

But the problem doesn’t stop there. We are all acutely aware of 

the fact that we now have an increasingly globalized food market. 

We import foods from all over the world, apparently more than 

200,000 registered foreign food facilities. How much does each inspection cost? Do you have any kind of estimate you can give? 

Mr. HUBBARD. Domestic inspection or HACCP inspection can be 

around $3,000 and regular sanitation GMP inspection can be 

around $2,000. So they are not cheap. 

Mr. WAXMAN. Well, if we are talking about having FDA inspect 

over 360,000 facilities with some regularity, that is an overwhelming task in terms of the workload, and it will obviously cost 

a great deal. 

I have heard many suggest that the answers to extend FDA’s 

workforce by supplementing it with private inspectors working on 

behalf of FDA, but I want to raise some concerns about that. There 

was a recent article in ‘‘The New York Times’’ that raised problems 

with these private inspectors. They say that food company being inspected often hires and pays for its own private inspector creating 

a conflict of interest, how those private inspectors frequently did 

not catch the problems at plants, whose products later sickened 

consumers. 

And some of those companies who later were found to have contaminated products were even given excellent or superior or ratings. That was the case with both PCA peanut outbreak and with 

the children’s snack Veggie Booty in 2007. 

So in some ways, I am even more concerned about the notion of 

relying on private inspectors in foreign countries. Obviously the 

primary reason domestic companies want to import from other 

countries is that these products are less expensive. And the reason 

they are less expensive is usually that they are not produced under 

strong food safety protection. So relying on third parties in those 

countries raises some serious questions. 

My fundamental concern with a third-party system for imported 

foods governed by FDA is that it still puts a huge burden and responsibility on FDA. I think that a company benefiting from the 

importation of cheaper products and ingredients should have a 

duty to check up on these foreign companies and be held accountable when there are failures. 

Indeed, some companies are already doing very thorough inspections of their foreign suppliers on their own. Do you agree that a 

company should have a responsibility to check on its own suppliers? And if we are forced to rely on third-party private inspectors, what sort of protections do you think can be put into place to 

address some of these concerns? 

Mr. HUBBARD. Yes, Mr. Chairman. You have touched upon a very 

important issue, and it may be your single hardest policy choice in 

this debate because you are absolutely right. The third-party system has not proven itself to be working properly now. It clearly is 


rfrederick on DSK6VPTVN1PROD with HEARING
107 

not working. FDA does believe that there are ways of beefing up 

that system—— 

Mr. WAXMAN. Don’t pay attention to that. 

Mr. HUBBARD [continuing]. With prohibitions against conflict of 

interest, with better training, with FDA audits behind them. The 

fundamental dilemma is you can never have enough inspectors to 

go to 316,000 facilities of FDA inspectors. But on the other hand, 

these third-party folks need to be under a very serious regimen of 

oversight, and I do think that your question about having the importers, the U.S. importer bear more responsibility for the quality 

of the product they are buying from, say, China is an important 

piece of it. 

And, in fact, the major food companies are beginning to acknowledge that they need to do that, that they need to know who they 

are buying from and what their quality is. And if they don’t know 

that, they should not be buying from that foreign firm. 

Ms. DEWAAL. Thank you. 

Mr. WAXMAN. Do you want to add anything to that? 

Ms. DEWAAL. I do. The concept you have laid out in terms of 

having the company take more responsibility works well when you 

are dealing with ingredients. But, sir, it doesn’t work so well when 

you are dealing with whole foods. There are a lot of foods that come 

in a port of entry and go directly into retail. And who is going to 

be that importer of record becomes a real issue because it is defined today in regulations. But it could give rise to some fly-bynight situations. 

Mr. WAXMAN. Well, we have to look at these concepts carefully 

because we can’t afford all the inspectors that we think we are 

going to need, and I don’t know that we can rely on all those thirdparty inspectors either to feel that we are being protected. 

I see my time has expired, and other members are waiting for 

their turn. So I will yield back the time I have overdone. 

Mr. PALLONE. Thank you, Chairman Waxman. I am going to ask 

Mr. Sarbanes to ask questions, and then that will be it before the 

votes. We have three votes, a 15, a 5, and a 5. So we will ask you 

to stay so we can continue with questions. So we will do Mr. Sarbanes, and then we will come back for the rest of the members. 

Mr. SARBANES. Thank you very much, Mr. Chairman. Thank you 

all for your testimony. I was particularly interested in the discussion about consumer confidence and how difficult it is going to be 

to restore consumer confidence. And I take it that, if I am hearing 

the discussion properly, even with the best food safety regime in 

place, there is still going to be outbreaks, right? So if you link your 

bid to boost consumer confidence to the notion that you would prevent outbreaks, that is sort of a dead-end aspiration. 

So it really comes then, I would imagine, the thing that is going 

to bolster consumer confidence the most effectively is a rapid response when there is—because that is the high profile incidences, 

right, that occur? Otherwise it is like oxygen. You are not going to 

notice it, right, if things are working well. So it is when there is 

an outbreak that you have a rapid response, that you have the 

traceability opportunities and so forth. And you show the public 

that you can quickly isolate it, you know, within hours, within 

days, whatever is feasible to do with a good safety regime. And 


rfrederick on DSK6VPTVN1PROD with HEARING
108 

then they come away from the experience saying, you know, the 

cop is on the beat. This is being handled, and, you know, we are 

protected. 

And I would just like to get your reaction to that. And maybe 

there is other leverage points to help with this consumer confidence 

question, but it seems to me that is probably one of the most obvious. Yes, Ms. DeWaal. 

Ms. DEWAAL. Thank you. You are right that we are always going 

to have outbreaks. The issue is how many and how big are they. 

The bills that you are considering address both ends. If we can prevent the problems from occurring, then the number of outbreaks 

will be reduced. If we can increase the traceability, the ability to 

find the contaminated product, then we are going to reduce the size 

of those outbreaks. 

So I think there are components that address both of those 

issues, but I think they are both essential. 

Mr. SARBANES. Any other comments? Yes? 

Mr. HUBBARD. I would like to make the point, Mr. Sarbanes, 

most of my career at the FDA, Roper and Washington Post and 

Harris polls showed FDA with the second highest consumer confidence in the entire—among all civilian agencies, next to the National Park Service. But since, 2000, that has reversed. 

Mr. SARBANES. Um-hum. 

Mr. HUBBARD. It used to be around 70 percent confidence level. 

Now it is around 30 percent. That is a tremendous reversal that 

I think reflects the kind of concern you are talking about because 

when FDA can’t find the source of these things quickly and then 

stamp them out, get the food out of the commerce, then I think the 

public just feels their government is not serving them well. 

So the speed at which outbreaks can be responded to and stopped 

is absolutely important. But that will require more than FDA. 

Mr. SARBANES. Right. 

Mr. HUBBARD. You have the CDC component, and then the state 

health departments are a big piece of that. 

Mr. SARBANES. Let me ask a question about the deterrent effect 

because you all have alluded to this. And I am just curious now 

where the number of inspections relative to the number of facilities 

and so forth is so low. I mean is there an operative deterrent effect 

at the current time, or not really? 

Mr. HUBBARD. I actually tracked that a few years back. As the 

inspections went down, the recalls went up. And the adverse findings from the FDA inspections that did get done went up. So in 

other words, as inspectors disappeared, the vigilance in the firms 

disappeared with them. 

Mr. SARBANES. Right. 

Mr. HUBBARD. So I think the fact that they think FDA might 

come helps, and the fact that, you know, FDA won’t come now is 

clearly not helpful. 

Mr. SARBANES. Well, and I imagine there is a sort of tipping 

point that you have to get past to create an effective deterrent in 

this process. I have no further questions. Thank you, Mr. Chairman. I yield back. 

Mr. PALLONE. Thank you. So we are going to break. We have 

three votes. Should be back in about half an hour, but we will come 


rfrederick on DSK6VPTVN1PROD with HEARING
109 

right back and finish with the rest of the members. Committee 

stands in recess. 

[Recess.] 

Mr. PALLONE. If I could ask the panel to take their seats again, 

and thank you. And our next member for questions is the gentlewoman from Florida, Ms. Castor. 

Ms. CASTOR. Thank you, Mr. Chairman. To the panel, just as 

folks all across the country would be surprised that FDA does not 

have mandatory recall authority, I think they would also be quite 

surprised that the FDA does not have the authority to fine bad actors. 

Has this always been the case? Compare that to other agencies 

that have that authority to institute civil monetary penalties and 

then if you would provide a recommendation on what you think an 

FDA reform food safety bill should contain. 

Mr. HUBBARD. I will give that a shot if I may. If you line up the 

various authorities of agencies all across government, the newer 

agencies tend to have a much broader range of authorities, such as 

civil money penalty and subpoena authority. 

FDA is one of the oldest agencies, and it was created in 1906. 

And at the time, it was believed that the way to enforce the law 

is to put the owner in jail if he sold a bad food. But, you know, 

you are not going to put the Kraft CEO in jail because one of his 

firms made a little mistake. And to enjoin the company that is 

making the food, which is a good thing, and seize the food if it was 

considered adulterated. 

But it did not give FDA these more modern tools that provide 

them more leverage. So, for instance, civil money penalties, the industry won’t like, but it is a nice intermediate tool to say OK, tomorrow it is going to cost you $1,000. And if you don’t fix it, it 

might cost you $2,000. And finally they will fix it. 

And those kind of flexible tools have been shown to be very helpful for FDA in other contexts such as medical devices where it does 

have that authority. 

So I absolutely encourage you to look at the modern toolbox that 

regulatory agencies have and consider giving FDA those tools as 

well. 

Ms. DEWAAL. We strongly agree. There are a whole set of tools, 

including things like even citizen sue provisions which are used in 

statutes that have been developed in the last 20 or 30 years. FDA 

doesn’t have any of this capacity. So I think the bill should include 

updating both the criminal penalty section but also giving this new 

authority for civil monetary penalties, traceability, and mandatory 

recall. Thank you. 

Mr. STENZEL. Honestly, Ms. Castor, I really don’t have the experience to answer the question historically or related to other agencies. I do think some of the civil penalty areas can make sense in 

this area as well. 

Ms. CASTOR. Anyone else? Are any states that you know of, have 

they adopted their own civil penalties under their state inspection 

regulatory authority? Do you know? OK, thank you very much, and 

I will yield back. 

Mr. PALLONE. Thank you. The gentlewoman from Ohio, Ms. Sutton. 


rfrederick on DSK6VPTVN1PROD with HEARING
110 

Ms. SUTTON. Thank you, Mr. Chairman, and thank you for the 

witnesses for waiting for us. A couple of things very quickly. Mr. 

Lugg, you made an observation that has been made here in the 

past in our oversight hearing in which when discussing the concept 

of required reporting of test results to the FDA, you indicated that 

that may result in the failure to test and have an opposite effect. 

But I have to tell you that after we heard that sort of proffered 

at the last hearing, I received a lot of feedback, and it was certainly running through my mind, from my constituents who all 

well, we will fix that. We will just make them test. And so I mean 

I just have to tell you that in the realm of America, people are like 

that seems ridiculous to this congresswoman and to the people at 

least who I heard back from. 

So I think we can correct that problem if we need to by mandating the test. And I just appreciate having the opportunity 

though to address that. The other questions that I have, a lot of 

you have talked about imports and the complex sort of questions 

that it creates in ensuring the safety of the process and the food 

that results on our dinner tables. 

Ms. DeWaal and I think, Dr. Cole, you also addressed this issue. 

And, Dr. Cole, I think, if I am not mistaken—let us see if I can 

find it—you explained the way that this works under the WTO. 

And I think that that is really, really helpful because I am not sure 

that people out and about really understand our limitations on ensuring the safety of imports into this country. That in many ways— 

and perhaps this is a simplification, and I certainly ask you to explain in more detail—but in summary, when I read your statement 

about this, in essence we rely on the standards of other countries. 

Is that sort of an accurate assessment, or would you like to expand 

on that? 

Mr. COLE. I think through WTO, appropriate level of protection 

is defined by the member, in this case a country, and the regulations are set up to provide a shield, not a sword. So if a country 

can decide that it is going to have a more stringent standard than 

the default CODEX standard, it needs to have evidence that its 

own safety system can meet that standard as well. That is kind of 

how it works in a nutshell. 

So there are frameworks there from CODEX that we can borrow 

from. There are default criteria that we can use. It doesn’t stop us 

setting our own standard, but we need to be able to show actually 

that we are meeting that standard for our own public health benefit, if you know what I mean. 

Ms. SUTTON. But with respect to the WTO and as things currently exist, you mentioned that the idea of what is considered 

‘‘reasonable’’ differs from country to country, and acceptable risk is 

culturally defined. 

And I think that those are important things for the American 

people to understand when we talk about certainly another subject 

that is related to this, and that is the way our trade system is 

working and what kind of exposures we have as a result of some 

of the policies that we follow. So I appreciate that assessment. 

Now, there are so many things that I would to explore more. But, 

Ms. DeWaal, as you noted in your testimony and we have heard 

some conversation here today about, the ability to access records 


rfrederick on DSK6VPTVN1PROD with HEARING
111 

from food manufacturers is now currently found in the Bioterrorism Act of 2002. And, of course, the FDA cannot demand access 

to food company’s records unless they believe that an article of food 

is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. 

And if you could just take this moment to explain how the limitations of working under that framework have resulted in adverse results. 

Ms. DEWAAL. Thank you for the question. Probably one of the 

best examples of the failing of records access when it was needed 

by FDA was in an inspection of another peanut butter processor. 

That company, and it was disclosed actually in this committee’s investigations, that company found that they had an inspection going 

on, and the inspector wanted to see the salmonella testing records. 

But the company itself said well, you have to submit the request 

in writing. FDA never circled back with that written request, and 

the company never disclosed those records. Another major 

multistate recall resulted from peanut butter linked to that company. 

It is clear that FDA does not have the record access that it needs 

under the Bioterrorism Act. So I think it is essential that in any 

legislation that should emerge from this process that that be fixed. 

And records access should be tied into this food safety plant. It 

should be broad. It should go to testing. It should go to processing 

records and corrective actions. Thank you. 

Mr. PALLONE. Thank you. Ms. Eshoo. 

Ms. ESHOO. Thanks again, Mr. Chairman, and thank you to the 

witnesses for your patience and waiting and for the testimony that 

you have given. 

I wanted to highlight something that appeared in the ‘‘New York 

Times’’ last week, and Chairman Waxman made reference to it. 

But I want to read this, and with your permission, Mr. Chairman, 

I would like to place the full article in the record of the hearing. 

Mr. PALLONE. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Ms. ESHOO. Thank you. The story starts out ‘‘when food industry 

giants like Kellogg want to ensure that American consumers are 

being protected from contaminated products, they rely on private 

inspectors like Eugene A. Hatfield. So last spring, Mr. Hatfield 

headed to the Peanut Corporation of America plant in southwest 

Georgia to make sure its chopped nuts, paste, and peanut butter 

were safe to use in things as diverse as granola bars and ice cream. 

The peanut company though knew in advance that Mr. Hatfield 

was coming. 

He had less than a day to check the entire plant, which processed several million pounds of peanuts a month. Mr. Hatfield, 66, 

an expert in fresh produce, was not aware that peanuts were readily susceptible to salmonella, which he was not required to test for 

anyway. And while he was inspecting the plant to reassure Kellogg 

and other food companies of its suitability as a supplier, the Peanut Corporation was paying for his efforts.’’ 

You can tell where I am going with this. Now, here is a quote. 

‘‘The overall food safety level of this facility was considered to be 

SUPERIOR’’—that is in capital letters—‘‘he concluded in his March 


rfrederick on DSK6VPTVN1PROD with HEARING
112 

27, 2008 report for his employer, the American Institute of Baking, 

which performs audits for major food companies. A copy of the 

audit was obtained by the ‘‘New York Times.’’ 

Now, it seems to me we have a big problem here. We know, according to your testimony, what it costs to do inspections. It is not 

cheap, but it seems to me that outside of national security, there 

are two major functions the government has—and I have always 

kept this with me, from local government to the Congress—public 

health and public safety. 

And this issue bears both responsibilities. We are now not only 

talking about preventing. We are talking about life and death in 

our system, the American system, that should be the gold standard 

of the world. So for the record, what I would like to know is do you 

think that this third-party, these private inspectors are really the 

best way to go? I mean it said in this article that the contributions 

of third-party audits to food safety are the same as the contribution 

of mail order diploma mills to education. 

Why don’t we start over here? I heard your comments earlier. 

Why don’t we start over here with Mr. Lugg? 

Mr. LUGG. Thank you for the question. That is a very good subject that you raise, and that is—— 

Ms. ESHOO. I know it is, but I want to know what you think of 

these private inspectors. Do you think they should be retained? Do 

you think they have a place in the system? Do you think that we 

can reform it so that private inspectors have to exercise more responsibility? Tell me what you think representing you—who are 

you representing? 

Mr. LUGG. Chiquita Brands—— 

Ms. ESHOO. Chiquita. 

Mr. LUGG [continuing]. International. 

Ms. ESHOO. Right. 

Mr. LUGG. Our philosophy has been from day one we cannot rely 

on third-party inspectors. 

Ms. ESHOO. Um-hum. 

Mr. LUGG. We do believe that there should be in place a system 

for licensing third-party inspectors, and they should be regularly 

brought in to keep their licenses in force. And—— 

Ms. ESHOO. So they are not paid by the very people that they are 

inspecting? Is that what you are saying? 

Mr. LUGG. Whoever pays, I didn’t address the payment issue. 

Ms. ESHOO. I see. 

Mr. LUGG. But I just am—— 

Ms. ESHOO. Well, how is what you just said, how does it differ 

from what we have today? 

Mr. LUGG. Well, we are very concerned that standards are different depending on the audit firms that do the audit. 

Ms. ESHOO. I see. 

Mr. LUGG. And if we always go back to the CODEX Almuntarius, 

which is a fundamental document and auditors are licensed based 

on their knowledge and so forth of how to conduct inspections, 

there should be an improvement in the third-party audit, regardless of who pays for it. 

Ms. ESHOO. Good. Mr. Stenzel. 


rfrederick on DSK6VPTVN1PROD with HEARING
113 

Mr. STENZEL. Congresswoman, I would say that private inspectors are an essential and important part of our food safety system 

today. 

Ms. ESHOO. But what I just read—— 

Mr. STENZEL. Because we have one example where it didn’t 

work—— 

Ms. ESHOO. But this is—so you think it is the only one? 

Mr. STENZEL. I didn’t say it is the only one, nor that it is the end 

of the solution. But private inspection is one way that private sector companies do audit each other, and that is an important part. 

No one is more concerned than Kellogg in that story that the people they hired to do inspections didn’t do an adequate job. 

Ms. ESHOO. But where is the safety valve in this, in what you 

are saying? 

Mr. STENZEL. But here is where I think is important when we 

get to this legislation. Should FDA incorporate third-party private 

inspectors? And if that becomes the case, then there has to be 

much more rigorous certification of inspectors. 

Ms. ESHOO. So you are acknowledging that there are holes in 

what the system does now? 

Mr. STENZEL. Absolutely. 

Ms. ESHOO. Good. All right. Well, at least you are doing that. I 

am glad. And, Mr. Chairman, I think that when we do a bill, we 

have to pay a lot of attention to this area. And I think that it is 

important to have a stand-alone NHHS. 

I worry a great deal that what Congress is going to fall back on 

is what we have done with so many other areas of FDA and fund 

it through some kind of user fee. And I don’t think that is the way 

to approach this. I think we are skating on very, very thin ice. 

I also think that Congress should be taking a look at an overlapping term for the FDA commissioner so that it is never politicized. 

I think it should be a six-year term and not be subject to the 

whims of politics that we have seen. That hasn’t come up today, 

but I think there is a lot of work to be done relative to the FDA. 

And if we come up with all kinds of reforms but we don’t fund 

what needs to be funded, we are going to be right back here with 

these good people hearing testimony all over again. So thank you. 

I was glad to return from the floor. I did want to ask the questions, 

and I thank the witnesses and the chairman. This is a big issue 

for us in the country. 

Mr. PALLONE. Thank you. Ms. DeGette. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. Mr. 

Stenzel, I wanted to ask you. With produce in particular, the industry now has the ability to trace produce not just from the field but 

from the exact part of the field it was planted all the way to the 

end wherever it is, the grocery store or the restaurant. Correct? 

Mr. STENZEL. That possibility exists. It is certainly not in place 

across the whole industry. 

Ms. DEGETTE. But it is done in parts of the industry? 

Mr. STENZEL. In some cases, yes. 

Ms. DEGETTE. Some companies have instituted voluntary 

traceability within their companies, correct? 

Mr. STENZEL. Absolutely. Many companies are doing that. 


rfrederick on DSK6VPTVN1PROD with HEARING
114 

Ms. DEGETTE. And, in fact, California has enacted standards 

that involve traceability, correct? 

Mr. STENZEL. Yes, ma’am. 

Ms. DEGETTE. And so I guess I am wondering what your industry’s view would be if we enacted traceability laws as part of comprehensive food safety legislation? 

Mr. STENZEL. I would comment on the whole area. Traceability 

is an essential part of food safety. I think it is something that we 

have to look at. I would first ask in the Bioterrorism Act in the one 

up, one down, I am not aware of any case where FDA has ever 

cited a company for failure to produce records in an adequate time. 

So a lot of what we talk about in produce traceability, even last 

summer’s episode was chasing the wrong commodity. 

Ms. DEGETTE. Right. 

Mr. STENZEL. Not the fact they couldn’t trace the tomatoes. 

Ms. DEGETTE. Right. Well, we need to fix the one up one down 

too. 

Mr. STENZEL. Right. 

Ms. DEGETTE. I think everybody agrees with that. But if we did 

fix that, we could do traceability. 

Mr. STENZEL. On traceability for produce, about 18 months ago, 

our industry launched an industry-wide initiative to handle bulk 

produce. If it is in a bag or if it is in a package, you have a UPC 

code, and it is much more easily tracked. But for bulk produce in 

cartons—— 

Ms. DEGETTE. I hope you don’t mind if I interrupt you. 

Mr. STENZEL. Please. 

Ms. DEGETTE. I only have 5 minutes, and the question I asked 

you was does your industry support traceability? 

Mr. STENZEL. We are doing everything we can to implement 

traceability across the—— 

Ms. DEGETTE. And would you support it as part of a comprehensive—— 

Mr. STENZEL. Certainly as part of comprehensive food safety. 

Ms. DEGETTE [continuing]. Legislation. Thank you very much. 

And, Mr. Lugg, what is your view on traceability? Would you be 

supportive as well? 

Mr. LUGG. We certainly are 100 percent supportive, and if you 

look at any of our packaged salads, you can trace them immediately. 

Ms. DEGETTE. Now, Mr. Hubbard, I want to ask you a question 

about traceability because, as you know, we have discussed this in 

my legislation. And I have also talked about it with Ms. DeWaal. 

So you might actually have some input too. 

What my traceability legislation says is that the FDA shall develop guidelines for each different industry. Do we have the technology to do that in the different parts of the food industry? 

Mr. HUBBARD. I think we do, and in fact, I think the tomato folks 

showed some of that technology to you last summer. And clearly 

there is bar code and radio frequency identification technology and 

others that allow you to track a product all the way back to its origin. And the Defense Department is using it for everything from 

tanks to nuts and bolts. And so it is becoming widely used anyway. 


rfrederick on DSK6VPTVN1PROD with HEARING
115 

And I would hope that that might be one avenue for a solution 

here. 

Ms. DEGETTE. This is an issue we started talking about some 

years ago. And people in the industry didn’t think that they could 

do it. And so they opposed it, but now I call it the salsa fiasco of 

last year where first we thought it was tomatoes, then jalapenos. 

And it took months and months. It not only hurt the consumers, 

it devastated the tomato industry. I think people are now realizing 

not just the health benefits but the commercial benefits. 

Ms. DeWaal, I wanted to ask you a question. I think you talked 

about this before, and I just wanted to put a little fine point on it. 

With the peanut problems we have had this year, it seems to me 

that the types of records production, you would both need to have 

mandatory inspections of some kind in every industry. And you 

would also have to have mandatory production of those documents 

because if you just had mandatory production of the documents 

without the mandatory inspections, then people might not do the 

inspections. Is that what you were saying? 

Ms. DEWAAL. That is correct. The inspections are an essential 

part of the enforcement program. This is to prevent outbreaks from 

occurring. The records production should be part of that, and also 

mandatory testing for certain pathogens that might be linked to 

those products. So all of this goes into a preventive approach. 

Ms. DEGETTE. Right, because you don’t want people to get sick 

in the first place if possible. I just have one last question for all 

the witnesses if you can just answer yes or no. Would you support 

mandatory recall authority for the FDA as part of comprehensive 

food safety legislation? 

Ms. DEWAAL. Yes. 

Mr. HUBBARD. Yes. 

Mr. COLE. Yes. 

Mr. STENZEL. Yes. 

Mr. LUGG. And yes. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

Mr. PALLONE. Thank you. Mr. Stupak. 

Mr. STUPAK. Thank you, Mr. Chairman, and thanks for allowing 

me to sit in even though I am not part of the subcommittee. You 

know my interest in this and in our legislation. The hearing focused today a lot on inspection fees, certifications, even brought up 

the 6-year term for the FDA commissioner. But no matter what we 

do in this field, whether it is inspection fees or whatever we are 

doing, we still have to change the culture of the FDA. 

You can have all the laws and all the money in the world, but 

if we don’t have a culture at the FDA that is willing to be aggressive in this area, we are still going to have food-borne illnesses. For 

instance, we talked a lot about the tomato industry. The tomato industry and members of our Committee on Oversight Investigations 

repeatedly told the FDA because of the time of the outbreak, the 

only place that tomatoes could have possibly affected it were from 

south Florida. South Florida has a very good trace back and certification of their product. So it couldn’t have come from the United 

States. 

But what did the FDA do? They still—and if you go to their Web 

site today—still insist it is tomatoes. They have killed the tomato 


rfrederick on DSK6VPTVN1PROD with HEARING
116 

industry. Last year, $125 million they lost because the FDA 

wouldn’t listen to anybody. And we find out it is jalapenos out of 

Mexico. But go to Web site, the tomato industry is still being associated with this outbreak. So I think we need leadership at the 

FDA, and we haven’t had that. 

Mr. Hubbard, you said that we can never make food 100 percent 

safe, and I guess I would tend to agree with you somewhat. And 

then you said that there are gaps in our food safety system. What 

are those gaps? 

Mr. HUBBARD. Well, principally, it is that the system relies upon 

this infrequent inspection process and forces FDA to pay got-you or 

state inspectors, instead of putting the burden on the producer to 

demonstrate at all times that they are producing a safe food. That 

is the paradigm shift that needs to occur. 

Mr. STUPAK. OK, let me ask you this. Our committee’s research 

has found that more than 10 years ago, recommendations to develop a national food protection training center have been repeated 

made, yet no action has been taken to date. 

More than 8 years ago, the Department of Health and Human 

Services office of inspector general concluded that an effective food 

safety system depends on the collective effort and coordination 

among federal, state, and local levels on government. Yet that 

same report noted the FDA provides limited training for state food 

protection professionals, and that states themselves cannot afford 

the cost of such training. 

Nearly 2 years ago, the FDA issued program standards, which 

requires states to have training plans that ensure all inspectors receive training required to adequately perform their work assignments. Still only a few states have done it. So let me ask do we 

need a national food protection training center to train state and 

local inspectors to federal standards, and maybe even these private 

inspectors we have heard so much about today? 

Mr. HUBBARD. I think we do, and in fact, I would urge you to 

consider in your legislation authorizing or mandating that FDA 

creates such a thing. I think the Georgia example showed that 

states were not perhaps up to snuff, and these third-party inspectors, as several members have raised, clearly are not up to snuff 

either. So that sort of a training academy would, in my view, raise 

standards for everyone. 

Mr. STUPAK. OK, there is some limited training, I know, through 

University of Maryland, but it is very limited. You don’t have to 

go through it, so we are almost looking like a college curriculum. 

That is being developed through some legislation. That is why I 

wanted to ask you that question. 

But let me ask you this, and if you know this. What is the current practice? Like take the PCA, Peanut Corporation of America. 

Georgia and Texas state inspectors inspected it. What happened to 

those reports? Do they go to the FDA and sit on a shelf or in someone’s computer program? Is there an internal audit about what is 

being done in these inspections? 

We heard about Mr. Hatfield from Ms. Eshoo about never inspecting or gave a superior rating. The one in Texas received a 

very good rating. Is there an internal audit conducted by the FDA 


rfrederick on DSK6VPTVN1PROD with HEARING
117 

then of these reports that come in? Or do they just sit until something happens? Do you know? 

Mr. HUBBARD. Well, there is the paper process that says how it 

should work, and there is a way it apparently really works. What 

should have happened in that case is that state inspector should 

have been trained to an FDA standard, which I gathered didn’t 

happen. 

Mr. STUPAK. Right. 

Mr. HUBBARD. Then they should have presented the FDA with 

the findings, but, of course as you know, the state inspector didn’t 

find any problems. So, you know, I suppose you could argue there 

was nothing for FDA to follow up on. 

Mr. STUPAK. But wouldn’t the FDA at least have some standards 

like especially since you had the 97 ConAgra peanut butter outbreak? Wouldn’t they at least inspect for salmonella? 

Mr. HUBBARD. They did do guidance after that ConAgra example, 

and the way it works is the FDA actually commissions state officials. So when they go in, they carry two badges, the Georgia badge 

and the FDA badge. And they are supposed to do the equivalent 

of an FDA inspection, but that apparently did not happen in this 

case. 

Mr. STUPAK. Correct, because a true FDA inspection takes a little bit of time. I think you indicated $2,000 up to $5,000 for an inspection and more than 8 hours. 

Mr. HUBBARD. Yes, on average, an FDA inspection of that nature 

would take a day to a day and a half, whereas state inspections are 

often done in a couple of hours. 

Mr. STUPAK. So even if these inspectors are trained, certified, everything, you still need an internal audit of what they are doing, 

or someone at the FDA looking at this to make sure it is being 

done properly, do we not? 

Mr. HUBBARD. I think you are right. 

Mr. STUPAK. OK, was there ever internal audits like that of state 

inspectors on foods? Do you know in your time there? 

Mr. HUBBARD. You know, I am sorry. I don’t know, but I would 

hope so. 

Mr. STUPAK. Well, I think that is one of the questions in our follow up period that we are having next week is, you know, were 

there internal audits and what was going on with these things? 

One more if I may, Mr. Chairman. 

Mr. Lugg, you indicated that I think your first priority, you said, 

when you come to work on food is you select the land and then you 

watch the water and that. Is that in this country or other countries 

too? Chiquita bananas come from all over, right? Costa Rica, everywhere? 

Mr. LUGG. Yes, our company operates in approximately 70 countries around the world, but particularly in the Fresh Express packaged salads, whether the product is coming from Guatemala, which 

we have to get our snow peas from in winter months, or down in 

Chile where get in the winter months. We send our own inspecting 

staff down to locate the land, and then we use special, global, 

geospacial technology to make sure that those lots are actually 

being harvested when they say they were. 


rfrederick on DSK6VPTVN1PROD with HEARING
118 

Mr. STUPAK. OK, what about the chemicals that they use during 

the process? Is that all approved by your company? 

Mr. LUGG. Those are chemicals that we approve, and then there 

are samples taken to make sure that they are within the residue 

limits. 

Mr. STUPAK. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Stupak. Let me thank the whole 

panel. I mean we are done with our questions, but, you know, we 

really do appreciate your input not only today but throughout the 

process. Mr. Stupak has had hearings and hearings in the full Government Reform Committee with Mr. Waxman. We do intend to 

move a bill. You know, I this subcommittee, probably our next 

hearing will be a legislative hearing on legislation that we would 

move. We are still waiting for the new FDA. I mean there isn’t a 

commissioner. So we would still like to get that input. But, you 

know, it is our intention to move fairly quickly. 

So thank you very much. We appreciate all your input. Without 

objection, this meeting of the subcommittee is adjourned. 

[Whereupon, at 1:25 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


rfrederick on DSK6VPTVN1PROD with HEARING
119 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 127 here 67100A.068
120 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 128 here 67100A.069
121 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 129 here 67100A.070
122 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 130 here 67100A.071
123 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 131 here 67100A.072
124 


rfrederick on DSK6VPTVN1PROD with HEARINGInsert offset folio 132 here 67100A.073