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

73–752 2012

FOOD SAFETY ENHANCEMENT ACT OF 2009 

DISCUSSION DRAFT 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

JUNE 3, 2009 

Serial No. 111–41 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


srobinson on DSK4SPTVN1PROD 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 S. 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) 


srobinson on DSK4SPTVN1PROD 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 


srobinson on DSK4SPTVN1PROD with HEARING

srobinson on DSK4SPTVN1PROD 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 

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

opening statement ................................................................................................ 3 

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

California, opening statement ............................................................................. 4 

Prepared statement .......................................................................................... 7 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 11 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 11 

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

opening statement ................................................................................................ 13 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 15 

Hon. Steve Buyer, a Representative in Congress from the State of Indiana, 

opening statement ................................................................................................ 16 

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

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

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

Texas, opening statement .................................................................................... 17 

Prepared statement .......................................................................................... 20 

Hon. Jane Harman, a Representative in Congress from the State of California, opening statement .................................................................................... 23 

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

Tennessee, opening statement ............................................................................ 23 

Prepared statement .......................................................................................... 25 

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

Islands, opening statement ................................................................................. 27 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 27 

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

opening statement ................................................................................................ 28 

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

opening statement ................................................................................................ 29 

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

opening statement ................................................................................................ 30 

Hon. Mike Rogers, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 31 

Hon. Tammy Baldwin, a Representative in Congress from the State of Wisconsin, opening statement ................................................................................... 32 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 33 

Hon. Bruce L. Braley, a Representative in Congress from the State of Iowa, 

opening statement ................................................................................................ 34 

Hon. John P. Sarbanes, a Representative in Congress from the State of 

Maryland, opening statement ............................................................................. 35 

Hon. Christopher S. Murphy, a Representative in Congress from the State 

of Connecticut, opening statement ..................................................................... 35 

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

opening statement ................................................................................................ 36 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, opening statement .................................................................................... 37 

Prepared statement .......................................................................................... 39 


srobinson on DSK4SPTVN1PROD with HEARING
Page

VI 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 40 

WITNESSES

Margaret Hamburg, Commissioner, Food and Drug Administration .................. 41 

Prepared statement .......................................................................................... 44 

Answers to submitted questions ...................................................................... 155 

Michael Ambrosio, Food Marketing Institute, Vice President, Quality Assurance Division, Wakefern Food Corporation ....................................................... 78 

Prepared statement .......................................................................................... 81 

Pamela G. Bailey, President and Chief Executive Officer, Grocery Manufacturers Association ................................................................................................ 89 

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

Answers to submitted questions 1

Caroline Smith DeWaal, Safe Food Coalition, Food Safety Director, Center 

for Science in the Public Interest ....................................................................... 97 

Prepared statement .......................................................................................... 99 

Answers to submitted questions ...................................................................... 186 

Tim F. Jones, State Epidemiologist, Tennessee Department of Health .............. 110 

Prepared statement .......................................................................................... 112 

Thomas E. Stenzel, President and CEO, United Fresh Produce Association ..... 120 

Prepared statement .......................................................................................... 122 

SUBMITTED MATERIAL

Statement of Wisconsin Department of Agriculture, Trade, and Consumer 

Protection, submitted by Ms. Baldwin ............................................................... 141 

Letter of June 3, 2009, from Commissioner Hamburg to Subcommittee, submitted by Mr. Stupak .......................................................................................... 148 

Statement of the American Frozen Food Institute ............................................... 149 

1 Ms. Bailey did not respond to submitted questions for the record. 


srobinson on DSK4SPTVN1PROD with HEARING
(1) 

FOOD SAFETY ENHANCEMENT ACT OF 2009 

DISCUSSION DRAFT 

WEDNESDAY, JUNE 3, 2009 

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

The subcommittee met, pursuant to call, at 10:05 a.m., in Room 

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

[Chairman of the subcommittee] presiding. 

Members present: Representatives Pallone, Dingell, Eshoo, 

Green, DeGette, Schakowsky, Baldwin, Ross, Matheson, Harman, 

Barrow, Christensen, Castor, Sarbanes, Murphy of Connecticut, 

Space, Sutton, Braley, Waxman (ex officio), Stupak, Markey, Deal, 

Whitfield, Shimkus, Buyer, Rogers, Murphy of Pennsylvania, Burgess, Blackburn, Gingrey and Barton (ex officio). 

Staff present: Karen Nelson, Staff Director/Chief Health Counsel; 

Rachel Sher, Health Counsel; Eric Flamm, FDA Detail; Elana 

Leventhal, Legislative Assistant; Virgil Miller, Professional Staff; 

Alvin Banks, Staff Assistant; Ryan Long, Minority Chief Health 

Counsel; and Chad Grant, Minority Legislative Assistant. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. The meeting of the subcommittee is called to 

order, and today we are meeting to review the Food Safety Enhancement Act of 2009 Discussion Draft. I will recognize myself for 

an opening statement initially. This discussion draft was released 

by Chairman Waxman, Chairman Emeritus Dingell, Chairman 

Stupak, Representative DeGette, Representative Sutton and myself 

early last week. And the draft builds on several bills already introduced in this Congress including H.R. 759, a bill that I, along with 

Chairman Dingell and Stupak, introduced earlier this year. 

The Energy and Commerce Committee has done a lot of work on 

the issue of food safety. In this subcommittee alone, we have had 

four hearings on this topic in the last two years. The information 

we learned during these hearings as well as during the numerous 

conversation we had with stakeholders groups and the FDA has 

been incorporated into the draft before us today. 

And I believe this draft bill represents a strong, well thought out 

approach to improving the FDA and its food safety activities. We 

have heard time and again that our current food safety system is 

broken. It is a system that relies heavily on the FDA rather than 


srobinson on DSK4SPTVN1PROD with HEARING
2 

placing the responsibilities on the manufacturers to ensure the 

safety of their products. It is a system that is geared towards responding to food outbreaks rather than one that is aimed at preventing them. 

And this system does not work, and recent outbreaks of E. coli 

in spinach and salmonella in peppers and peanut butter highlight 

that fact. Unfortunately, these are not isolated instances. Each 

year, 76 million Americans get sick due to unsafe food products. 

Every year, 325,000 individuals will be hospitalized and 5,000 will 

die from food borne hazards. 

It is estimated that the medical costs and lost productivity due to food borne diseases cost us $44 billion annually. And these illnesses are completely preventable. 

The good news is that there seems to be agreement that something must be done and that it must be done quickly. The President has made food safety of one his priorities. He has assembled 

a food safety working group to come up with principles on this 

issue. 

Chairman Waxman, Mr. Dingell, Mr. Stupak and I have worked 

closely with key stakeholders on this discussion draft, and as we 

move forward with the legislation, we hope to continue those conversations as well as conversations with our counterparts on this 

committee. 

The bill we are discussing today will modernize the food safety 

laws currently in place. It places a strong emphasis on prevention 

and shifts the responsibility for food safety onto those who actually 

make the food. It also provides the FDA with the necessary resources and enforcement authorities to ensure that all companies 

are in compliance with the new requirements. This draft bill would 

require all food manufacturing companies to register annually with 

the FDA so that the agency has an up-to-date list of all facilities 

who sell products in the United States. 

It focuses on prevention by requiring companies to conduct thorough hazard and risk analysis of the products that they are making. It mandates that companies put in place preventive controls to 

mitigate and minimize those identified hazards. And it requires 

companies to document all the steps they have taken to implement 

and verify the controls to ensure they are effectively minimizing 

hazards. 

The bill also addresses the shortfalls of our current traceback 

system by requiring the FDA to establish an electronic interoperable record keeping system that manufacturers would be required 

to use. This measure will allow the agency to quickly trace the 

source of an outbreak back to its origin and prevent and minimize 

the number of individuals affected by a food borne illness. 

While shifting responsibility for food safety onto the manufacturers, the draft also recognizes the crucial role the FDA needs to play 

in this realm. This draft requires the agency to set standards for 

food safety and hold the food industry accountable for meeting 

those standards. It provides the FDA with stronger enforcement 

authorities, such as recall authority and access to records. 

The bill also increases the inspection frequency for food facilities, 

requiring that the FDA inspect facilities at an established minimum frequency. 


srobinson on DSK4SPTVN1PROD with HEARING
3 

Now we are going to hear today from industry experts about the 

various provisions in this discussion draft, and I look forward to 

those conversations. I hope that we can all continue to work in this 

collaborative manner as we move to markup of food safety legislation in this committee. 

I am very pleased to welcome Dr. Margaret Hamburg of the FDA 

today. We had a meeting last week while we were doing the Energy markup. We were in the back having some conversations, and 

I was very impressed with her. This is the first time she will be 

testifying before this committee, and I thank her for being here. 

I also want to thank our other witnesses for appearing before us 

today. I especially want to welcome back Mike Ambrosio. He is, of 

course, from my home state. Good to see you again, Mike. And I 

will now recognize Mr. Deal for an opening statement. 

OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. DEAL. Thank you, Chairman Pallone, for holding this hearing today, and thanks to our distinguished witnesses who have 

joined us to review this draft of the Food Safety Enhancement Act 

of 2009. I look forward to your testimony and to the questions that 

our committee will actually have of the panels. 

As a resident of the state of Georgia, which has already received 

a focal point focus of the issue of food safety, I know firsthand the 

perspective that our Nation has on the issue of the lack of safeguards and fallback measures that many people expect of a 21st 

century food supply chain in our country. 

We all agree food safety is a priority, and 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. 

Additionally, implementation of preventive controls such as hazard analysis and critical point plans included in the draft under 

discussion is an important step forward in ensuring unsafe food 

products don’t reach store shelves in the first place. 

As we know, preventing compromised food from entering the 

market is the best line of defense to preventing food related illnesses. I also believe it is important to enhance FDA’s ability to 

conduct onsite inspections of food facilities. The inspection schedule 

established under the draft does recognize risk profiles for food in 

terms of how frequently facilities should be inspected. But the regimen set forth in the discussion draft fails to address the cost/benefit factor of conducting such frequent inspections and could possibly result in insufficient oversight of certain higher-risk facilities 

due to time and manpower limitations of our inspectors. 

It is my hope that our witnesses today can provide input with 

regard to an appropriate inspection schedule, which achieves the 

goal of ensuring safe food for the American people without placing 

an undue burden and strain on the FDA, which is already challenged under current food safety obligations. 

This legislation authorizes an annual pay-to-play registration fee 

for domestic and foreign food facilities of $1,000 to supplement appropriations made by Congress to FDA. In discussion, however, we 

have not been able to determine from the majority or the FDA exVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
4 

actly how much funding is necessary to meet the requirements of 

this bill. 

I believe it would be premature to impose significant fees on industry and in turn the American consumers without any reference 

as to how much funding is actually needed. If the majority remains 

intent on imposing such registration fees, we must also be certain 

these fees are limited to cover the activities such as a minimal fee 

paid to the FDA for an application to cover the cost of review and 

processing. 

If the goal is to improve food safety, we must ensure that funds 

are not funneled into other activities that may or may not have 

anything to do with improving food safety, a situation which I believe could occur under the language of the current proposal. Obviously these are issues, among many others, that I feel hopefully 

this committee will be able to address as we move this issue forward, and I look forward to the hearing today and the results that 

come out of it. 

I appreciate Chairman Pallone and Chairman Waxman’s bipartisan efforts on this issue, and look forward to having a product 

that all the members of this committee can support. And thank 

you, Mr. Chairman, for the time. 

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

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you very much, Mr. Chairman. This subcommittee and our full committee is beginning the process today of 

passing critically important legislation designed to revamp our Nation’s food safety system. The Food Safety Enhancement Act of 

2009 and this hearing marks a key milestone. 

Over the past few years, a series of food borne disease outbreaks 

in spinach, peanuts, and peppers, just to name a few, have laid 

bare some major gaps in our antiquated food safety laws. Oversight 

work by GAO and by our own Oversight Committee has also helped 

us understand where we need to focus our efforts to bring our food 

safety laws into the 21st century. 

The draft legislation that is the subject of today’s hearing is 

based on the FDA Globalization Act of 2009 introduced by Chairman Emeritus Dingell, Chairman Pallone, and Chairman Stupak. 

And I commend them for their work on that bill and their continued efforts in shaping this new bill. 

I also want to recognize the assistance we have received from the 

Obama administration. We have worked closely with the FDA to 

identify problems with the current food safety law and to find 

workable solutions. We will not be passing legislation that sets up 

the agency to fail. The bill requires that the agency set tough 

standards, but we have given them the flexibility to prioritize and 

address the most important risks first. 

The draft also incorporates helpful suggestions from Ranking 

Members Barton and Deal and Representative Shimkus. I believe 

we can reach a bipartisan agreement and look forward to continuing to work with all the members of this committee. 


srobinson on DSK4SPTVN1PROD with HEARING
5 

In working with the FDA on this legislation, one thing was abundantly clear. The administration is absolutely committed to overhauling FDA’s food safety program. I think we will all see that 

commitment today when we hear from Commissioner Hamburg. 

The recent food outbreaks have exposed glaring holes in FDA’s 

basic food safety authorities. FDA does not have routine access to 

any records kept by the food manufacturers. FDA cannot require 

companies to conduct a recall of unsafe foods. The agency can only 

ask and hope that the company complies. FDA also lacks basic 

modern enforcement tools like administrative civil monetary penalties. The Food Safety Enhancement Act will give FDA these and 

other critical authorities. 

One of the most important changes that will occur under this bill 

is a focus on prevention. The legislation does not anticipate that 

FDA alone will protect us from unsafe food. The hallmark of any 

effective food safety goal must be a shared responsibility for food 

safety oversight between FDA and industry. 

The act will strike the right balance in this shared responsibility. 

The bill will require manufacturers to implement preventive systems to stop outbreaks before they occur and will give FDA the 

tools it needs to hold them accountable if they fail. Under the bill, 

FDA will also have clear authority to issue and require manufacturers to meet strong enforceable performance standards to ensure 

the safety of various types of food. 

I commend many of those in industry for recognizing the importance of this prevention model and coming to the table to support 

it. 

Let me turn briefly to one of the more contentious issues in the 

bill, the registration fees. I wish we did not have to resort to industry fees to supplement funding for FDA’s work. However, when it 

comes to FDA’s food program, the shortfall in revenues is extreme. 

The FDA’s own science board told us that the FDA is so starved 

for resources that American lives are at risk. We cannot realistically expect appropriations alone to provide sufficient resources to 

close that gap. 

The recent outbreaks have also taken a major toll on the food industry. In the recent peanut outbreak, Kellogg’s alone lost $70 million. Faced with such a dire situation, I think it is reasonable to 

ask the food industry to chip in. A robust food safety oversight system will provide a great benefit to industry by preventing future 

outbreaks and rebuilding consumer confidence. 

Let me be clear. We are not asking industry to cover the entire 

cost of the bill or any single part of the bill like the cost of inspections. The bill establishes a set fee of $1,000 per year per facility. 

FDA is prohibited from increasing that fee in future years except 

to cover the cost of inflation. The bill simply asks industry to chip 

in its fair share. 

I also want to address another concern I have heard, the presence of FDA on farms. FDA has always had the authority of foods 

on farms, and they have generally relied on state and local authorities for food safety oversight on farms because they have a strong 

on-farm presence. I am confident that farmers have nothing to fear 

from this bill. The bill calls for FDA to set its standards through 


srobinson on DSK4SPTVN1PROD with HEARING
6 

regulation, which means that FDA will go through a public notice 

and comment process. 

Our committee is busy in the middle of three months period. 

Last month, we passed a comprehensive energy and climate change 

legislation. Soon we will take up health care reform, but food safety 

is so critical that I have carved out time right in between to pass 

this legislation. Over the next few weeks, I intend to work with all 

our committee members, Democratic and Republican, with the 

FDA, with the affected industries, to achieve a consensus on a food 

safety bill that we can pass out of committee. We can’t afford to 

wait any longer. 

I look forward to hearing from our witnesses today. Thank you, 

Mr. Chairman. 

[The prepared statement of Mr. Waxman follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
7 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 12 here 73752A.001
8 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 13 here 73752A.002
9 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 14 here 73752A.003
10 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 15 here 73752A.004
11 

Mr. PALLONE. Thank you, Chairman Waxman. The gentleman 

from Kentucky, Mr. Whitfield. 

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY 

Mr. WHITFIELD. Well, thank you, Mr. Chairman, and we appreciate your having this hearing on this very important issue today. 

We all recognize that FDA has many very important responsibilities, and we have known through hearings for the last number of 

years that the resources available are always in question, but we 

recognize also that there is a definite need for reform of FDA. And 

we are delighted that Dr. Hamburg is here with us today to provide testimony and the other panel of witnesses as well. 

We look forward to working with the majority on this important 

legislation. And having said that, we do have some significant concerns about some provisions in this legislation, particularly the 

risk-based inspection portion, particularly that relating to the lowrisk facilities. Also the traceability provisions that I understand, for 

example, would apply to every convenience store in the country. In 

addition to that, the recall provisions in this legislation, the country of origin provisions, particularly as it relates to the Web site 

requirements and then also, of course, the power that we give to 

FDA for subpoenas and other instruments to obtain company 

records. I think we need to look at those provisions much more 

closely. 

But obviously this is an important piece of legislation. We look 

forward to working with you and listening to the testimony of our 

witnesses today. Thank you. 

Mr. PALLONE. Thank you. Next is our Chairman Emeritus, Mr. 

Dingell, and thank you for all you have done on this legislation. 

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. DINGELL. Mr. Chairman, thank you, and thank you for holding today’s legislative hearing on the Food Safety Enhancement Act 

of 2009 Discussion Draft. We have worked together, you and I, 

with Chairman Stupak and others over the years. And I am delighted to say that this legislation is ready for enactment and is almost old enough to vote. 

I want to say that I am delighted that Chairman Waxman and 

my good colleagues, Ms. DeGette and Ms. Sutton, have joined us 

in our work on this bill. 

We are about to try and fund an agency which is hollow, which 

does not have either the personnel or the revenue or the money or 

the or the resources which it needs to do its job. And we are about 

for the first time since 1962, when I was a young member of this 

body, to try and see to it that it gets its authorities updated to deal 

with the real problems in the world of trade and in the world marketplace. 

I am pleased that we are taking the necessary steps to advance 

this legislation and address the important issue of food safety. I am 


srobinson on DSK4SPTVN1PROD with HEARING
12 

hopeful that we will shortly be doing something with regard to 

pharmaceuticals. 

I want to thank the witnesses who have joined us today and look 

forward to hearing their testimony. And, Dr. Hamburg, welcome to 

the committee. Congratulations on your confirmation. I was encouraged by the administration’s early recognition that food safety is a 

problem that needs to be addressed. The administration food safety 

working group is a signal to how serious the President considers 

this issue. 

And I want to thank you for the way that you and your staff 

have provided timely and helpful technical advice on the legislation. 

I want to note that I am hearing complaints from folks about the 

fee system. I want to make a note that the only part of Food and 

Drug that seems to be working is that which functions under 

PDUFA and that and which has the advantage of having industry 

participate in the funding. I want to note that the industry seems 

to be prospering mightily under that particular section and be getting service from Food and Drug in a proper way. And that seems 

to be about the only place that the industry is getting protection 

or the American consumers are receiving necessary safety. 

In 1938, the Congress comprehensively addressed the issue of 

food and safety. Seventy years later, Food and Drug Administration 

is still trying to protect the larger, increasingly global supply with 

outdated statutes and inadequate resources. As a result, the American consumer confidence in the Nation’s food supply and the Food 

and Drug Administration and, quite frankly, in this body, the Congress, has declined. And American consumers are being forced to 

pay a heavy price, not only with recall after recall but also the fact 

that people are being sickened and killed by unsafe foods and also 

by pharmaceuticals. 

And again I wish to hope that we will commence work on pharmaceuticals as soon as this business is attended to. The Food Safety Enhancement Act is a measured and effective response to the 

dire situation we are faced with today regarding food safety. 

Mr. Chairman, the legislation is based on a bill you, Chairman 

Stupak, and I have introduced earlier this year and also on a bill 

that was introduced by me during the past Congress. It includes 

good technical advice from FDA and valued input from the minority and other stakeholders. And I want to make it clear that I am 

working with the minority to try and resolve their concerns, and 

that we are also working with the industry. 

And I want to thank my friends in the industry for the goodwill 

which they have shown in working with us. And I also want to 

thank Chairman Waxman for his leadership on this point. I look 

forward to continued deliberations in the hope of producing speedily a bipartisan piece of legislation that will pass the committee 

and the House, as I have indicated, both in a correct and a speedy 

fashion. 

Amongst other things, this bill will prevent safety problems before they occur. It will require manufacturers to implement food 

safety plans that identify and protect against food hazards. It will 

see that Food and Drug has the authority to see to it that good 

manufacturing practices are adhered to here in the United States 


srobinson on DSK4SPTVN1PROD with HEARING
13 

and elsewhere, especially in places like China which is in fact the 

Wild West in this particular matter. 

It will advance the science of food safety, increase inspection frequency of food facilities, something which can happen more often 

on dog food manufacturers under the jurisdiction of the Department of Agriculture than it happens with regard to manufacturers 

who manufacture food products for the safety of our people. 

It will enhance FDA’s ability to trace the origin of tainted food 

in the event of an outbreak or food borne illness. And it should be 

noted that the Food and Drug Administration and the industry are 

totally incapable of providing speedy service in this particular. 

It will enhance the safety of imported food. FDA will be allowed 

to require that certain foods be certified as meeting U.S. safety 

standards and again to trace. But also Food and Drug will be able 

to finally get enough people at the doors of this country to see to 

it that safety is properly enforced and that good manufacturing 

practices are adhered to around the world for the protection of our 

people. 

It will provide strong enforcement tools including mandatory food 

recall authority, stronger criminal and civil penalties for bad actors, subpoena authority, and it will increase and strengthen Food 

and Drug’s detention authority. 

Finally, and I would argue more importantly, the legislation addresses the very important question of resources of the agency. We 

will give the agency the authorities it needs, and we would do them 

a grave disservice if we did not give them the resources they need. 

The legislation includes the registration fee, which will fund food 

safety activities at FDA. The revenue from this fee, coupled with 

additional appropriations which we hope we can get out of those 

skinflints at the Appropriations Committee, the office of managing 

the budget, will ensure that Food and Drug can do its job. 

For those who argue there is no benefit for the industry to pay 

a fee for safety activities at Food and Drug, I offer the following. 

U.S. peanut industry could lose $1 billion this year because of the 

outbreak of salmonella that forced the biggest food recall in history. 

That has just been replicated by other recalls in the food industry. 

Tomato industry lost $100 million in sales during the 2008 salmonella outbreak that ultimately was attributed to jalapeno peppers. Spinach growers took a $200 million hit to their industry during a 2006 bagged spinach recall. 

And let us not forget that wonderful Chilean grape scare of 1989, 

which Food and Drug had neither the authority nor the competence 

to address. I ask unanimous consent to revise and extend my remarks. I have a few other things I would like to say that I know 

everybody will want to read. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Chairman Dingell. The gentleman 

from Illinois, Mr. Shimkus. 

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

Mr. SHIMKUS. Thank you, Mr. Chairman. Dr. Hamburg, welcome. 

I see Chairman Waxman has left the room. I appreciate his comments about there being some discussions. I do have to have admit 

that the discussions that we have had when we point out a point 


srobinson on DSK4SPTVN1PROD with HEARING
14 

that is correct, they accept. When there is a debatable point, Mr. 

Chairman, there does not seem to be any movement and compromise. So I would encourage more discussions on some of these 

issues if we really want this to be a bipartisan bill. 

You know the other thing I have trouble with is draft hearings. 

If we are going to have a legislative hearing, let us have the legislation. This is the draft legislation, and if we had the great draft 

legislation hearing on climate change and then when the bill came 

before us, it had 300 additional pages in it. And there is fear on 

our part that this is a sneaky way to say yes, we had a legislative 

hearing, but you really don’t have a legislation hearing if you don’t 

have the legislation before you. 

This is the Democratic majority operandi. We claim a crisis. Only 

government can be the savior. Government must get bigger, and 

the middle class pays. And that is the issue here. And I was on 

ONI in the last Congress with Bart Stupak, readily accepting the 

premise that we have to get inspectors into these facilities, and we 

are ready to address an issue that is thoughtful and respectful and 

pays for the inspectors and facilities where they are not going into. 

And it is not like we haven’t done anything. Congress, last Congress, approximately $57 million from the supplemental went to 

food safety. The House passed the 2009 omnibus appropriated an 

additional $325 million for the FDA with $140 million of the $325 

million would go for food safety programs. In the President’s 2010 

budget, he included $1 billion additional to FDA for food safety. 

So there is a huge commitment already for massive federal funds 

to go to food safety. Now we have, as our concern, a bill, a draft 

that has, what, $325 million for no explanation, no earmarking, no 

direction, and that is where a lot of our questions will be today is 

why that amount? What justifies that amount? How are we going 

to ensure that it is not going to be used for other purposes? And 

the like. 

So I would ask the leadership on the other side that if they really 

want a bipartisan, let us get some bipartisan negotiations, sincere 

negotiations. I would be honored to yield. 

Mr. DINGELL. I am very fond of the gentleman. He is very well 

noticed, and I have great respect for him. And I have been talking, 

as the gentleman well knows, to the leadership on the minority 

side both in the last Congress and this Congress. I want this legislation to be bipartisan. I don’t want the gentleman to be surprised. 

I would note to my good friend that we have been having hearings after hearings after hearings not only here but up in the Oversight Subcommittee. And during that time, I have been continually 

talking to my good friends on the minority side because I want you 

to be aboard. This should not be a partisan issue. And when we 

go to the next step in this process, I will assure the gentleman that 

most of the changes that will be made that will be changes that 

will be made as a result of discussions with my friends on the minority side. And I say that with respect. 

And I thank my colleague, and I look forward to working with 

you. I yield back, Mr. Chairman. 

Mr. PALLONE. Next is the gentlewoman from Colorado, Ms. 

DeGette. 


srobinson on DSK4SPTVN1PROD with HEARING
15 

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

Ms. DEGETTE. Thank you, Mr. Chairman. Mr. Chairman, this is 

the first step towards realizing a long-held dream, not just by me 

and other members of this committee but by the millions of Americans who have been concerned about the safety of our food, especially in light of the cascading litany of food borne illnesses that we 

have heard about from other members of this committee. 

We have had a dozen Oversight hearings and also legislative 

hearings. We have had bills dropped by many members of Congress 

for many years, and I am so excited under your leadership and the 

leadership of Chairman Waxman and Chairman Dingell that we 

are finally on the verge of enacting comprehensive food legislation. 

The most important thing about this bill is it would be a definitive statement by this committee and this Congress that food safety 

is a priority in the United States of America. 

I want to highlight two of the sections of this bill, and I want 

to thank you and Mr. Dingell and others and Mr. Stupak for including the provisions of my two bills in this draft mark because 

they are critically important in the future to assuring safe food for 

everybody. 

As you know, Mr. Chairman, I have been working on these 

traceability issues for many, many years. And when I first started, 

people said it couldn’t be done. But then as we realized with time, 

not only can it be done and in slightly different ways in every industry, but if we want to assure this integrity of the food system, 

it has to be done. What I fondly call the salsa scare of last year 

is the perfect example of why. 

We found people being sickened by salsa, and we couldn’t figure 

out why. This destroyed pretty much the entire profit of the tomato 

crop for that whole year because everybody thought it was tomatoes that had the salmonella. As it turned out, after months and 

months and months of increased sickness, of increased scrutiny, we 

found out that no, it wasn’t the tomatoes at all. It was jalapenos, 

and they were from Texas. 

And what I found out is that we can go to this particular sector 

of the field and find those jalapenos, and we can do it quickly. So 

traceability is going to be essential. And I look forward to working 

with my friends on the other side of the aisle to make sure it is 

not onerous. But I will say this. It is not just in the interest of consumers. It is in the interest of businesses who want to protect their 

profits to have traceability. 

Mandatory recall is a second provision of this bill that I have 

been working on for many years and I am so grateful has been included. 

And I want to say finally, Mr. Chairman, all of this policy that 

we talk about, it is all well and good. But I can’t help but think 

about young Jacob Hurley, who you might have seen. He was in 

our last ONI committee hearing. 

Jacob is from Portland, Oregon, and he got sick from eating peanut butter crackers, his favorite food. When his parents took him 

to the doctor, they said they finally got him stabilized, and he 

wouldn’t eat. So they told the parents have Jacob just eat what he 


srobinson on DSK4SPTVN1PROD with HEARING
16 

loves, the peanut butter crackers, the very food that had made him 

sick in the first place. 

And the only way we found out about this was because the alert 

commissioner of Consumer Protection in Oregon showed up personally at his door and confiscated the peanut butter crackers. We 

need to fix this. We need to fix it now, and I am so grateful that 

we are. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Ms. DeGette. Next is the gentleman 

from Indiana, Mr. Buyer. 

Mr. BUYER. Ma’am, welcome to the committee. Is it Hamburg or 

Hamburg? 

Dr. HAMBURG. Hamburg. 

OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF INDIANA 

Mr. BUYER. Hamburg. Welcome, and my first reaction to the discussion draft is going to lead to some questions that I will have for 

you today. It appears that Congress a lot of times would like to 

pound our chest and then show the American people that we are 

doing something well. 

But we really end up creating legislation within our own areas 

of jurisdiction, and we create problems. We create things that are 

multiplicious and redundancies. And if we really wanted to couple 

substance with the words that I have heard here from some of my 

colleagues today, we would be working with other committees of jurisdiction. We would have a very comprehensive bill. And so I am 

going to be asking you questions, ma’am, about clear lines of delineations and responsibilities between USDA and FDA, and who 

should really have what responsibility. 

Or should we as a Nation put all food under one agency and 

work cooperatively with the Ag Committee to do something like 

that? What we have is a discussion draft that has been cleverly 

drafted only within the jurisdiction of our own committee, and so 

what we end up doing is are we exasperating a problem? And so 

I am interested in your leadership. You are representing an administration, and so I am interested in your best counsel to us and 

your willingness to work with leaders of other agencies to truly 

protect the American people. 

And the other point I make is that Congress, as of late, has been 

beating up on FDA. I would say the FDA, the individuals that I 

have met and the ones that you have the privilege to lead are some 

pretty fine and capable and dedicated individuals. 

In the last, gosh, 16 years, 17 years that I have been here, 

whether it has been Republicans in control or Democrats, we continue to pass legislation that heaps more and more responsibilities 

upon your core missions. And so here is your challenge to maintain 

the gold standards, not only with regard to pharmaceuticals but 

also in food, you know, we are about to send you legislation for a 

new mission on tobacco that is counter to your even cultural mission. 

Yet we are going to continue to make you the whipping post, and 

so I am really concerned about the more responsibilities we give 

you, how much does that dilute your responsibilities? And so these 


srobinson on DSK4SPTVN1PROD with HEARING
17 

are some of the questions that I am going to be posing to you. And 

with that, I yield back. 

Mr. PALLONE. Thank you. Gentleman from Georgia, Mr. Barrow. 

OPENING STATEMENT OF HON. JOHN BARROW, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. BARROW. I thank the chair, and I appreciate the leadership 

you are showing on this issue. This is a matter of particular interest to me since, as Mr. Deal has already pointed out, two of the 

most egregious recent cases of tainted food in the food supply originate in my state of Georgia, and I think this bill represents a 

major step forward in trying to prevent this from happening again. 

One of the things that is a particular bone of contention with me 

is that in the last outbreak, we got evidence in this committee that 

the manufacturer had test results which were showing positive 

presence of salmonella. The food that was sent out in the marketplace was tainted, and yet they didn’t report that to the FDA. 

Seems to me that we need to have, in addition to the good measures that have been incorporated in this bill, is an effective testing 

regime that has integrity in terms of sampling and integrity in 

terms of testing. And I think we have to make it easy for folks to 

be able to do this, to comply with this, and mandatory for them to 

report the results of any testing. 

This way I think we can pick the bad actors out very early on 

and perhaps even do a better job of arresting trends at a very early 

stage, detecting problems before they become serious. 

Above all, I want to make sure that we don’t bring about the Sergeant Shultz syndrome. You know he was the comic characters in 

Hogan’s Heroes, and he had a big, loud comic demonstration every 

now and then of not knowing what was inconvenient for him to 

know. So we want to make sure that folks don’t have the option 

of opting out or have a disincentive to know what they need to 

know when they need to know it. And that we know what they 

know when they need to know it. So that is the balance I think we 

need to strike here. I look forward to working with my colleagues 

on this as we try and incorporate provisions like that in this bill. 

And with that, Mr. Chairman, I yield back. Thank you. 

Mr. PALLONE. Thank you. Gentleman from Texas, Mr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank the chairman. Dr. Hamburg, Dr. 

Sharpstein, good to see you again. Spent some time yesterday out 

at the FDA’s facility, and I will echo the comments of Mr. Buyer. 

You have a wonderful staff that you lead out there. They are obviously very, very dedicated individuals, sometimes working under 

the adverse conditions that we supply. But certainly I know you 

are very proud of the organization of which you lead, and I believe 

that pride is justified. 

Mr. Chairman, I am going to stipulate to all of the difficulties 

that the Food and Drug Administration is encountering that have 

already been well-documented, and I would ask unanimous consent 

to insert my entire statement into the record. Let me just concentrate on the aspect that we are now finally, after I don’t know 


srobinson on DSK4SPTVN1PROD with HEARING
18 

how many hearings on this, getting down to somewhat of the business of acting for the FDA and talking about legislation that would 

give the Food and Drug Administration some tools. 

But we are also giving them a timeframe, which may prove to 

be a very difficult timeframe for implementation. And we are also 

putting some additional burden on businesses at a time that our 

economy is in some difficulty. The legislation proposed will mandate the largest change in food safety in at least two decades, and 

it will give the entire food industry a compressed time to do so. In 

a few short months, we will have to turn the current system of 

paper-based records into electronic form. Businesses will have to 

find the money to register as a food facility, and additional user 

fees, if we deem them appropriate in the future, and they will have 

to be able to fully trace the food to its place of origin. 

All those may be laudable goals, but I am not certain that what 

we are proposing as a timeframe is adequate. And then the Food 

and Drug Administration itself, in that shortened compressed timeframe, will have to hire enough inspectors to meet the new inspection standards, create unique identifier numbers for every food facility, be they domestic or foreign, set up a new administrative law 

position for the new criminal and civil penalties, and make certain 

that each center has a food safety plan, all of this instantly demanded in one piece of legislation. 

I would just point out when we did the Consumer Products Safety Improvement Act last year, H.R. 4040, we acted in good faith, 

and we acted with some dispatch. But we created some situations 

that are absolutely untenable. We have had to go back and try to 

amend some of those. We have driven some small businesses to the 

point of bankruptcy. We have created a situation where our resale 

shops, because they cannot measure the lead standard that we required, are in a position that they don’t know whether they can sell 

the goods that have been donated or not. 

So I urge us to take every due caution. The law of unintended 

consequences has a very short turnaround time in our current 

globalized world, and we need to be cognizant of that. 

And then finally, let me just, you know, a word about bipartisanship. A bill is bipartisan if it is bipartisan at the beginning. And 

Chairman Dingell, I appreciate the courtesy that you showed me 

in the last Congress at involving me in at least some of the preliminary discussions of the draft that you were considering. But really 

when the draft comes to the committee for consideration, it really 

ought to have had input from both sides, and the fact that there 

are five or six Democrats on the bill and no Republican. Was there 

no Republican on this side of the dais with which you could sit 

down and talk and perhaps get to a point where there could be 

some general agreement? 

We have done this before on other pieces of legislation. We did 

it on the Food and Drug Reauthorization Act in June of 2007. And 

I frankly do not understand why it is not worth the effort to make 

these pieces of legislation—we are not talking about points for the 

next election. We are talking about the regime that will be in place 

that will ensure the safety of the food for my grandson and 

Marsha’s grandchildren. This is the legacy that we are going to be 

leaving, and it is too important to be left to partisan politics. 


srobinson on DSK4SPTVN1PROD with HEARING
19 

And I thank you for the additional time, Mr. Chairman, I will 

yield back. 

[The prepared statement of Mr. Burgess follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
20 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 25 here 73752A.005
21 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 26 here 73752A.006
22 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 27 here 73752A.007
23 

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

Harman. 

OPENING STATEMENT OF HON. JANE HARMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Ms. HARMAN. Thank you, Mr. Chairman. I would like to welcome 

Peggy Hamburg, an old friend, a brilliant physician, and a superbly 

qualified person to this committee and to her new role as FDA commissioner. I think you bring a lot to this job and will help this committee which has worked on the issue of food safety for years and 

years and years come to a thoughtful, careful, healthful decision on 

the shape of this legislation. So welcome. 

Mr. Chairman, I am very comfortable with the discussion draft, 

and I do know that it reflects many, many years of input from 

members. I thought that John Dingell’s comment that it is almost 

old enough to vote was particularly apt. That applies to me too. 

And I think that coming from a state like California, which is the 

largest agricultural producer in the country, we ignore food safety 

at our peril. The vice chairman, Diana DeGette was chronicling 

some of the recent outbreaks and how important it is to have 

traceability and mandatory recall. I agree. And we could have 

saved a lot of pain, a lot of cost, and a lot of health problems had 

we had those measures in place. 

So I just want to conclude by saying that we have an able and 

willing partner facing us this morning. I think we have an able and 

willing committee on a bipartisan basis to engage with her, and I 

am very eager to see us make progress and to enact legislation 

close to the committee draft as soon as possible. It is in our national interest, and surely as we talk about grandchildren, it is in 

our grandchildren’s interest. I yield back the balance of my time. 

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

Blackburn. 

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

Ms. BLACKBURN. Thank you, Mr. Chairman, and I want to welcome Dr. Tim Jones who is going to be on our second panel. He is 

hiding over here in the back. He must be one of these Baptists 

from Tennessee. He is going to sit in the back row until time for 

him to come forward. But Dr. Jones is an epidemiologist with the 

Department of Health in our great state. Does a wonderful job for 

our state, and I am absolutely delighted that we are going to be 

able to hear from him today on the second panel. So, Dr. Jones, 

thank you for taking the time to come. 

While the draft legislation before us today attempts to improve 

the safety and the efficacy of the Nation’s food supply, it appears 

that there is still a lot of room for improvement. And I am appreciative that we are having the hearing, and I am hopeful that we 

are going to be able to work in a bipartisan way on this issue. 

I appreciate the majority’s attempt to improve the country’s food 

safety system, but I think that we all know, especially those of us 

who are mothers, we know that you can’t inspect your way to food 

safety. We know that this legislation is going to have to do more 


srobinson on DSK4SPTVN1PROD with HEARING
24 

than be reactive. This legislation broadly increases the FDA authority to make it one of the largest federal agencies in the existence. 

My concern is the growth of bureaucracy, and what is going to 

happen as that bureaucracy grows. What I do think is necessary 

and I think it is necessary that our system be risk-based, that it 

be preventative, and take that approach, and that it effectively target bad actors. 

It is imperative that resources are focused on issues of high risk 

and innovations that are most effective. However, this bill places 

undue burden on small businesses, and they would be harmed by 

burdensome and expensive provisions that are found in this current draft of this legislation. 

The FDA has provided no evidence that it has improved its internal processes in order to improve the review of the Nation’s food 

supply. This is something we have talked about endlessly in this 

committee and in hearings. So we are looking forward to having 

some questions on this. 

There seems to be—and you haven’t proven otherwise—that 

there are established protocols and lines of communication between 

different jurisdictions. You have not shown that there are best 

practices. Indeed, about 13 months ago, I asked for a list of best 

practices on intra-agency communication and how you are sharing 

this information, how you are working with your affiliates so that 

everyone can more easily pinpoint and get to the bottom of problems and bad actors and issues that are coming forward. 

And yesterday, the FDA announced that they are studying ways 

to make the agency more transparent. This should have been done 

before we pass a bill that would give the agency millions of dollars 

in user fees. And I am going to yield my time back and submit my 

full statement for the record and look forward to the questions. 

[The prepared statement of Ms. Blackburn follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
25 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 30 here 73752A.008
26 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 31 here 73752A.009
27 

Mr. PALLONE. Thank you. Gentlewoman from the Virgin Islands, 

Ms. Christensen. 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 

REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS 

Ms. CHRISTENSEN. Thank you, Mr. Chairman, and welcome back, 

Dr. Hamburg. I know New York has suffered a great loss, but the 

Nation needs you more. I also think it is very fitting that as we 

have come back to Congress and begin to put the nuts and bolts 

on our health care reform legislation that the first hearing that 

this committee is having is with FDA because I believe we will 

begin that reform with an overhaul and a better resourcing of the 

Food and Drug Administration. 

From the Food Safety Enhancement Act of 2009 that we are 

looking at in draft today and the Family Smoking Prevention and 

Control Act of 2009, we are looking at a new FDA, and you have 

the challenge as well as the opportunity to remake this important 

institution in ways that it better serves the health of the American 

public while also fostering, guiding, and supporting the bringing of 

new and better treatments to us as well. 

I have confidence in a better resource FDA with more authority 

and one that is not overly prescriptive. I don’t want to be overly 

prescriptive on what we tell the agency to do, but I hope that we 

will be able to allow the agency to do its job based on clear authority, adequate resources, and sound science. 

In the case of food safety, in this my first few months on this 

committee, I have really been alarmed to find out what has happened that has put the public’s health in jeopardy from salmonella 

to some questions about even the IRB process and several other 

areas. So we are here to help you create a better, stronger FDA, 

and this hearing is part of that process. And I thank you and all 

of the panelists for sharing their experience and expertise with us 

this morning. 

Mr. PALLONE. Thank you. Gentleman from Pennsylvania, Mr. 

Murphy. 

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

Mr. MURPHY OF PENNSYLVANIA. Thank you, Mr. Chairman, and 

welcome, Dr. Hamburg. Pennsylvania’s number one industry is agriculture, and with that comes a lot of food processing. We are honored to have national companies located in Pennsylvania like Hershey’s. We have companies like Welch’s grows a lot of grapes there. 

And more locally in the Pittsburgh area, regional distributors of 

groceries like Giant Eagle, national distributors of olive products 

like Delalow’s, and of course big names like Del Monte and the corporate headquarters of Heinz, and small companies like Sarah’s 

Chocolates that sells around the country. 

All of them have talked with us about concerns for this bill and 

certainly are very supportive of making sure we have a strong 

FDA, and we want to make sure that happens. 

A few questions were raised, and I hope I will be able to remain 

for part of this hearing; although, I have to run to the floor, and 


srobinson on DSK4SPTVN1PROD with HEARING
28 

I apologize for that. I will miss some of this, but a number of 

issues: making sure that there is no unintended consequences of 

the bill that leads to increased price for consumers. Let us work on 

that, on the registration fee, particularly as it may affect some 

smaller businesses trying to work. 

Also, with regard to the traceability, need to be clear what exactly the obligations are for both the processed and fresh food industry. Are we talking about traceability of final product or 

traceability of every ingredient that went into the product? 

For example, if a local restaurant chain makes cookies or someone else makes cookies, trying to track every single ingredient that 

comes up with a specific food color dye may be a problem for them 

and would like to make sure we make that work for the safety of 

consumers but not in a way that impairs companies from doing 

their work. 

And also unintended consequences of giving the FDA copies of all 

test results could be less testing. As companies go through lots and 

lots of test for products that never make it to market, would it be— 

to test the hundreds of samples each day have to be available or 

change to the testing of products that are in the marketplace? 

With regard to the country of origin labeling and disclosure, to 

list every ingredient on a Web site could increase the costs and resources and not necessarily bring added value. Could there be some 

general labels such as some statement that this product may contain ingredients from one or more of the follow countries? 

Also how about raising the importance of making sure that all 

enforcement officers and auditors are well-trained and calibrated to 

work to define audit standard? There is also concern of what happens with the family farm that may sell to local grocery stores. To 

what level would they have to comply? And would it be that the 

fees for them would be so high that they simply could not sell any 

products outside of their own farm store? And as that impairs some 

smaller distributors, how do we help them? 

Another issue for grocery stores, what if they make packaged 

food at their stores such as some value-added ground beef products 

made in the meat departments? What happens if they mix in other 

foods at their store? How does the bill affect them in other ways? 

So certainly in Pennsylvania we want strong food safety bills. We 

want ones that protect consumers. We want small businesses to be 

encouraged and large businesses to be supported but also encourage new startups. But more than anything else this week we want 

the Penguins to win the Stanley Cup, and I yield back. 

Mr. PALLONE. Thank you. Gentleman from Texas, Mr. Green. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Mr. Chairman, I want to thank you for holding the 

hearing today on the discussion draft of the food safety legislation. 

Over the past year or so, there have been several high profile food 

contamination incidents in the United States involving spinach, 

cantaloupes, peanut butter, and tomatoes. This committee has diligently investigated all of these incidents. 

These hearings on the FDA have clearly shown us that the FDA 

simply does not have the resources, funding, or manpower and 


srobinson on DSK4SPTVN1PROD with HEARING
29 

technology it needs to protect the American food supply and fulfill 

its mission. 

Chairman Dingell, Chairman Pallone, and Chairman Stupak 

have worked tirelessly on this proposed legislation. I would like to 

applaud them for their dedication on this issue. I am hopeful for 

this hearing and the discussion draft will bring us one step closer 

to passing food safety legislation out of the House. 

I had a brief chance to review the legislation. I would like to 

briefly discuss a couple of issues that concern me. The discussion 

draft allows for food imported to be inspected by third-party accredited labs to conduct sample analysis. I support the provision, but 

I would like to see an investment in instruction in FDA labs. 

The port of Houston is the largest port in the U.S. in terms of 

foreign tonnage, and a large portion of that is related to our energy 

industry. But the port imported 606,000 tons of imported food in 

2007. The port of Houston does not have an FDA lab, and surprisingly there is no FDA lab in Texas even though we share the longest border with Mexico. I have yet to understand why Texas with 

its level of trade and southern border with Mexico does not have 

an FDA lab. In fact, there are over 300 ports of entry in the United 

States, and only 13 ports actually have FDA labs. 

I hope my colleague from Arkansas will forgive me, but the closest FDA lab to Houston and the entire state of Texas is located in 

Arkansas. 

Houston is not the only import area in Texas. Cities like Laredo, 

Texas that is one of the largest land-locked ports of entry in the 

world imports from Mexico literally thousands of trailers on a 

weekly basis. It seems unwise and frankly unsafe to have the FDA 

lab for the entire state of Texas located 100 miles away in another 

state. 

The location of FDA labs throughout the U.S. needs to be evaluated and a report should be submitted to Congress on whether the 

FDA labs are located where they are most needed. The discussion 

draft allows FDA to assess current FDA lab locations and to relocate labs as necessary. 

I would like to hear from the FDA on whether they have any 

plans to evaluate current lab, FDA lab locations. Congress also 

needs allocated funds to the building of more FDA labs. I was 

pleased to see the President’s budget. The allocation of funds was 

three high-volume FDA labs. If we want FDA to truly ensure the 

safety of our food supply, we need to build more FDA labs in areas 

where food imports are arriving, such as Houston, so the FDA can 

quickly and accurately test our food imports and ensure food safety. 

Again thank you, Mr. Chairman. Look forward to hearing our 

witnesses, and thank our new FDA director for appearing before 

the committee. 

Mr. PALLONE. Thank you, Mr. Green. Our ranking member, Mr. 

Barton. 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. Thank you, Mr. Chairman. I will be very brief. We 

support there being a legislative hearing and hearing on food safeVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00035 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
30 

ty. We think it is time to address this problem in a bipartisan fashion if at all possible. We do think it is important that we try to get 

it right if at all possible. 

We understand that it is your wish and the full committee chairman’s wish and former Chairman Dingell’s wish to move with legislation sometime this month. Republicans are ready to help if we 

can agree on a bill that provides the FDA with the tools that it 

needs to ensure the safety of our food supply. But we will not support new blanket authorities that are designed merely to empower 

the bureaucracy. 

Nearly everybody says that ‘‘we cannot inspect our way to foods 

safety.’’ We need systems that reliably prevent sickness by applying 

resources in those places that are most susceptible to contamination. The draft before us proposes several areas to strengthen prevention of food illness outbreaks such as requiring all manufacturers to have food safety plans and also the creation of appropriate 

produce standards. 

These ideas make sense and have near universal support. We are 

concerned however that parts of the draft add more weight than 

quality to the regulations and, in our opinion, provide too much 

discretion to the FDA without any corresponding food safety benefit. 

For example, country of origin labeling is not about food safety. 

As a practical matter, it will simply increase the cost of groceries 

at the store. We know this because expert after expert has testified 

at the committee that this provision has absolutely no effect on 

safety. 

There are several other specific concerns with the draft, including the level and the scope of the registration fees. I will say that 

the registration fees are less in this draft than they have been in 

some previous drafts so that I can at least say that we are moving 

in the right direction. 

Having said that, it does appear that the majority simply wants $300 to $400 million in additional funds for the FDA, and we can’t 

see that there is any clear purpose for that amount of funding. 

Having said that, we look forward to the hearings, and if we can 

work on some of these problems, we are prepared to be positively 

engaged in the markup that comes after the hearings. With that, 

Mr. Chairman, I will yield back. 

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

Ohio, Ms. Sutton. 

OPENING STATEMENT OF HON. BETTY SUTTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO 

Ms. SUTTON. Thank you, Mr. Chairman. Thank you for holding 

this hearing on this extraordinarily important issue. I want to extend my appreciation to the sponsor of this bill and all of those 

who, for so long, have been fighting the fight to fix our food safety 

system and make sure that the food that is on the table to feed our 

families is safe for their consumption. And that which goes with 

them to school, they can fear not that it will be safe for their children to eat. 

Chairman Emeritus Dingell, I thank you very much for your long 

effort in improving our food safety network, along with RepresentaVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00036 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
31 

tive Dingell, Representative Stupak and others on both sides of the 

aisle. And look forward to working with you. 

As you may know, the very first bill that I introduced in the 

House, I believe, was a bill to call for mandatory recall authority 

for the FDA. And there is a reason for that. I mean we have seen 

these problems arise again and again and again within our food 

safety network. And the American people, I think, would have been 

shocked, as I was, to learn that our government did not have the 

authority to issue a mandatory recall when it became apparent 

that it was necessary. 

Ohio has suffered the effects of problems with our food safety 

system. Most recently, the salmonella outbreak has claimed lives 

and harmed many throughout the Buckeye State, and it is critical 

that we are moving forward with a comprehensive bill to finally address and ensure the safety of America’s tables and our system. 

Thank you so much. I yield back. 

Mr. PALLONE. Thank you. Gentleman from Michigan, Mr. Rogers. 

OPENING STATEMENT OF HON. MIKE ROGERS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. ROGERS. Thank you, Mr. Chairman. Appreciate the hearing 

and congratulations, Commissioner, for your confirmation. I look 

forward to working with you. Some difficult issues ahead. 

I am glad this committee is focused on food safety. I think we 

can all agree that the FDA needs more resources to protect our 

food supply and strengthen public health. I am concerned, however, 

that this might be a ready-shoot-aim event. We just passed a fairly 

onerous bill and added a lot of authority to the FDA that had a 

huge loophole in it that allowed tobacco regulation to be borrowed 

from the general fund of the FDA. 

So you have this hole of millions and millions of dollars, of which 

you are going to have to try to apply to thousands and thousands 

of new regulators. At the same time, we are trying to improve food 

safety, and I can’t think of anything more important than our food 

supply. 

My hat is off to you, Commissioner, on the challenge of what you 

have just accepted. As we all know, the FDA is currently unable 

to inspect the majority of the Nation’s food facilities. Worse, many 

high-risk facilities have gone without inspection and oversight at 

all. Over the last two years, we have seen the impact of this failure: numerous salmonella and E. coli outbreaks, which have 

sickened thousands and even led to death. 

I hope that this bill could eventually be a bipartisan bill. However, many of the concerns that we have expressed have not been 

addressed, and we have not had the opportunity to sit down and 

have a discussion before this bill has come before the committee. 

And I think that is horribly unfortunate when you are talking 

about food safety and food safety issues. 

The user fees in this draft are concerning to me. As written, the 

bill would require $1,000 in registration fee per food facility, but 

these funds totaling about $375 million which will be passed along 

to consumers, which are regular families trying to pay their bills 

already, there is nothing in there that dedicates this to new inspections. 


srobinson on DSK4SPTVN1PROD with HEARING
32 

So we have come up with a new tax regimen that doesn’t benefit 

the FDA in getting it to the place where you need it most, which 

is inspectors for food facilities and food supply. Makes no sense to 

me, and that is something we absolutely have to change in this bill, 

or, Madam Commissioner, you are going to be looking at a very 

tough hole to fill again. There is nothing in here that tells the appropriators where to put that money so that you can best use it to 

accomplish the mission of which this bill will tell you it has to do 

without telling you where the money is coming from. 

That is almost dangerous when you think about this plus the 

FDA tobacco regulation authority that allows them to take your 

money for food supply inspections and drug approval and use it for 

hiring new regulators for tobacco. That is a real problem that we 

need to fix not only in this bill, at least I hope we can. 

If food producers are required to pay this new tax, they should 

absolutely have the certainty that the funds are going to be used 

for food safety inspections. I think that is common sense. I think 

we can all agree on it. I would hope to work with the majority to 

get that taken care of. 

In addition, the draft’s inspections schedule seems almost impossible to achieve. Today I hope, Commissioner, that you can shed 

some light on what a practical, risk-based inspection schedule 

should look like. And I hope you can cover that today in your statement and through questions. 

I also have several other concerns: the new, broad recall authorities. Recall authority is important, but how it is done is incredibly 

important. An expansive new civil penalty regime, new labeling requirements that don’t seem to have anything to do with food safety. 

Again I think all of these issues we can address if we work together in a bipartisan manner and, I think, come around something that we all believe needs to happen. And that is more resources for food inspection and food safety regimes that the FDA 

has a primary responsibility for. 

I look forward to working with you and thank you, Mr. Chairman, for this, I think, all important hearing. 

Mr. PALLONE. Thank you, Mr. Rogers. Gentlewoman from Wisconsin, Ms. Baldwin. 

OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WISCONSIN 

Ms. BALDWIN. Thank you, Mr. Chairman. I appreciate the fact 

that you are holding today’s hearing and also want to join my colleagues in commending you and Chairman Stupak and Chairman 

Emeritus Dingell and Chairman Waxman for putting this very important discussion draft before us that addresses very serious challenges that we face with respect to food safety. 

Before I begin my remarks, I would like to submit for the record 

written testimony from the Secretary of the Department of Agriculture Trade and Consumer Protection in the state of Wisconsin. 

Mr. PALLONE. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Ms. BALDWIN. Thank you, Mr. Chairman. Food safety is an issue 

of great concern to me and my constituents. Approximately one in 


srobinson on DSK4SPTVN1PROD with HEARING
33 

four people in this country are affected or sickened by food-borne 

disease each year. As Americans, we rely on government to keep 

us safe, and as government, we have fallen down on the job. 

As we consider this draft legislation, I know that our goal is to 

empower the FDA to prevent food contamination incidents before 

they occur. I hope that we do so with appropriate and sufficient resources, but also with precise coordination between other federal 

agencies, the states, and the private sector. 

Currently with its limited resources, the FDA focuses its inspections on large manufacturers engaged in interstate commerce, and 

it leaves much of the front line work to the states. This bill creates 

a risk-based inspection system that significantly increases the frequency of inspections. I want to make sure that we are not duplicating efforts and that we can empower states to perform their 

work on the ground with logistical and financial support. 

I urge the FDA to use this legislation to create a stronger, more 

integrated food safety system that leverages state and local resources. 

As another result of limited resources, FDA relies on many private sector firms to conduct food safety testing on a contractual 

basis. I am pleased that the discussion draft includes a provision 

that would allow a laboratory accreditation process facilitating the 

FDA’s use of third-party laboratories to perform testing. 

And I want to make sure that the conflict of interest language 

in the bill does not prevent some of the most experienced laboratories from maintaining their strong partnership with the FDA 

moving forward. 

I look forward to hearing your testimony, Dr. Hamburg, and that 

of the other witnesses today. And I thank you again, Mr. Chairman, for this hearing. 

Mr. PALLONE. Thank you. Gentleman from Georgia, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

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

health officials estimate that 76 million people become sick, 

325,000 are actually hospitalized, and 5,000 die each year from 

food-borne illnesses caused by contamination. Incidents like those 

in my own home state of Georgia, where the actions of a few bad 

actors and a breakdown in effective government oversight sickened 

more than 677 people in 45 states and caused at least nine deaths 

underscores the need for action. 

I agree with my colleagues that more needs to be done to ensure 

that the food products American consumers buy are safe. Additionally, I support the efforts of this committee as it reviews ways to 

streamline and improve the food inspection system in this country. 

Mr. Chairman, I hope that these hearings will continue to allow 

us the opportunity to reflect on the breakdowns in our current system, as well as the appropriate solutions to safeguard the health 

and welfare of all Americans. 

Madam Commissioner, I commend you for your recent appointment. Look forward to hearing from you and from the next panel 

of witnesses. And with that, Mr. Chairman, I yield back my time. 

Mr. PALLONE. Thank you. Gentleman from Iowa, Mr. Braley. 


srobinson on DSK4SPTVN1PROD with HEARING
34 

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF IOWA 

Mr. BRALEY. Thank you, Mr. Chairman. Welcome, Dr. Hamburg. 

I don’t think anyone sitting over here has anything but good wishes 

for you and the enormous challenges you face, and we wish you 

well and look forward to many fruitful and productive conversations with you. As vice chairman of the Oversight and Investigations Subcommittee, I have been very involved in the hearing that 

we have had up to this point on this important subject, and I am 

glad to see us finally getting to the point of considering legislation 

that is so critical to the health and safety of Americans. 

Throughout this process, we have seen examples of both good 

and bad actors in the food industry. Some companies like Nestle 

USA set the standard with proactive food safety audits and showed 

us what can happen when companies do the right thing in reaching 

out and doing their own investigations. 

On the other hand, we heard extensively about Peanut Corporation of America and its unsanitary and unsafe conditions and about 

its action to misrepresent the results of audits that were done, 

which put people at risk and cost people their lives. 

That is why we are here today to talk about what we can do to 

improve the current state of the situation. This Food Safety Enhancement Act will solve many of the FDA’s current limitations, 

and I am glad that it requires increased inspections of food facilities, tiered inspection systems that distinguish between high-risk 

facilities, low-risk facilities, and warehouses. And I also support the 

provisions to ensure the safety of imported foods, which is something I fought for since introduction of the Fresh Produce Safety 

Act last Congress. 

Also very importantly I am very proud that this bill has strong 

whistle-blower protections. And I believe that it will help keep 

America’s food supply safe. Many might consider some of the provisions in this bill burdensome. However it is important to look at 

opportunity costs of failing to take action to improve food safety. 

In our March 19 Oversight hearing, I asked David Mackey, who 

is the CEO of Kellogg, how much the PCA Salmonella outbreak 

had cost his company, and he replied between $65 and $70 million. 

The legislation before us today might have prevented that outbreak 

and saved those costs. 

Most important, however, is what we owe to the families of this 

country who have been injured or killed by unsafe foods and the 

desire to take real action to keep our food supply safe. 

In 2006, a graduate of Dubuque Wallard High School in my district, a marathon runner named Jill Cole contracted E. coli from a 

spinach salad that she ate. After 17 days in the hospital, she was 

released with just eight percent of her kidney function, and she 

now has to see a doctor twice a year to monitor her kidneys. Jill 

and all other Americans should be able to have faith that their food 

is safe, and we are here today to try to restore that faith. Thank 

you, Mr. Chairman. 

Mr. PALLONE. Thank you. Gentleman from Maryland, Mr. Sarbanes. 


srobinson on DSK4SPTVN1PROD with HEARING
35 

OPENING STATEMENT OF HON. JOHN P. SARBANES, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MARYLAND 

Mr. SARBANES. Thank you, Mr. Chairman. Welcome, Dr. Hamburg. We are so excited to see you in this position, and we look forward to your testimony on the proposed legislation. The comment 

has been made a couple of times that we can’t inspect our way to 

food safety, and that may be true. But we can non-inspect our way 

to food danger, which I think has been unfortunately the hallmark 

of what has happened in recent past. And so this bill that is proposed is going to put so much more emphasis and inspection on the 

front end, which is going to make a tremendous difference. 

When you look at the provisions that are contained in this proposed legislation, so many of them go under the heading of nobrainers. In other words, these are things that the average citizen 

would imagine are already in place and I think would be surprised 

to learn are not in place. 

And so there is so much about this bill that represents some of 

the pent-up needs and concerns of the American public that we 

need to address. On the economics, and there has been a fair 

amount of discussion about that already just in the opening statements. The better we do on the front end, of course, with monitoring and inspection, the less cost we are going to have on the 

back end, both in terms of FDA needing to scramble to deal with 

outbreaks of food-borne illness, but also to save cost of businesses 

of not having to deal with the effects of that. 

And I think that those saved costs will far outweigh the investment that we put in on the front end and certainly justify many 

of the measures that are contained in this bill. So we look forward 

to your testimony, welcome, and good luck to you. Yield back my 

time. 

Mr. PALLONE. Gentleman from Connecticut, Mr. Murphy. 

OPENING STATEMENT OF HON. CHRISTOPHER S. MURPHY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF CONNECTICUT 

Mr. MURPHY OF CONNECTICUT. Thank you, Mr. Chairman. I look 

forward to Dr. Hamburg’s testimony and members of the other 

panel. I think what we are talking about here today is setting very 

high but very reasonable expectations for what we can do out of the 

FDA. And I think that if that is our goal, we can get a product that 

both parties can be proud of. 

As the former chair of Connecticut’s public health committee, I 

know I speak for a lot of state policymakers in our feeling of helplessness over the past 5 to 10 years especially, and I think you are 

going to find, as this committee will find, a lot of allies in state 

public health networks. They are going to be very supportive of this 

transformation that you are undergoing to try to assist in their efforts, which have been very difficult over the past several years. 

Last thing, Mr. Chairman, I am very appreciative to you and to 

Mr. Dingell and others for including in this bill several aspects of 

the work that my colleague in Connecticut, chairwoman of the Agricultural Subcommittee of Appropriations Committee, Rosa 

Delauro. She has been working as a tireless advocate on this issue. 


srobinson on DSK4SPTVN1PROD with HEARING
36 

Parts of this bill relative to the inspection frequency for the riskiest 

foods out there, enforceable performance standards for food-borne 

standards are parts of her efforts incorporated into the underlying 

bill. And I appreciate you paying attention to her work here as 

well. Look forward to your testimony. Thank you for being here. 

Yield back. 

Mr. PALLONE. Thank you. Gentlewoman from Florida, Ms. Castor. 

OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA 

Ms. CASTOR. Thank you, Mr. Chairman. And kudos as well to 

Rosa Delauro and Bart Stupak and John Dingell, our colleagues 

here that have worked for many years to improve food safety in 

America. And welcome to Dr. Hamburg. Based upon your background, obviously you enjoy a challenge, and food safety is an important challenge for our country. 

Of all the issues we deal with in this subcommittee, food is the 

most ubiquitous. It is relevant to all Americans. I wanted to remind my colleagues that the Government Accountability Office—remember—keeps that very short list of major government problems 

that require broad transformation before they can ever hope to be 

effective. The list, called the high-risk series, includes notorious 

government failures such as the financial regulatory system, which 

failed to prevent the largest financial collapse in generations. It includes the implementation of the Homeland Security Department, 

which has been plagued from the beginning by cost overruns. And 

no surprise, it also include federal oversight of food safety. 

And here is an example from last year that really hurt in my 

home state of Florida. Tomatoes last year from Florida were 

blamed for a nationwide salmonella outbreak that was eventually 

traced to jalapeno and Serrano peppers from Mexico. In the meantime, FDA intimated at the time not to consume Florida tomatoes, 

and that cost our state and agricultural producers and hard working folks over $100 million. All of the time and effort spent hinting 

and suggesting that Florida tomatoes were the problem only served 

to delay the solution to the real problem and allow more Americans 

to get sick. 

Our committee understands the problem. This committee has 

held several hearings, and we understand that we must act expeditiously. Part of the problem lies in the lack of federal authority to 

effectively respond to a crisis. When FDA does not have incontrovertible proof of a specific food contamination, it cannot today 

issue a mandatory recall. Instead it must rely on corporations to 

voluntarily choose to pull inventory from the shelves. 

The FDA does not even have the ability to assess civil penalties. 

This legislation before us gives the FDA that long overdue enforcement authority. The problems facing food safety and oversight are 

legion, and they are difficult. But they are not insurmountable, and 

I am confident that we will move the Food Safety Enhancement 

Act of 2009 quickly and provide American consumers with a safe, 

transparent and reliable food supply. I yield back my time. 

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

Eshoo. 


srobinson on DSK4SPTVN1PROD with HEARING
37 

OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Ms. ESHOO. Thank you, Mr. Chairman, for having this important 

hearing on the Food Safety Enhancement Act of 2009, and I want 

to extend the warmest welcome and congratulations to Dr. Hamburg. She is a woman of exceptional talent, high intellect, a person 

with great character, and someone that has given much to their 

country already and comes from one of the most outstanding families, I think, in our country. You can tell how elated I am that the 

President chose so wisely in appointing you as FDA commissioner. 

We all look forward to working with you. To the extent that you 

succeed, the country is going to succeed. 

I also think that your tenure can be and will be the mark where 

the FDA returns to being the gold standard in terms of a public 

agency. The American people believe in the FDA. They want the 

FDA to succeed because what you do they can’t do for themselves. 

And the decisions that are taken can be the difference between life 

and death. That is how profound the decisions are. 

So I can’t tell you how thrilled I am that you are the one. I am 

pleased that the legislation that we are considering is going to improve the traceability of food because when tainted food is discovered, it is critical that we know where it has come from, where it 

has gone and what stores it is sold in. If sales are limited to a certain area, targeted recall could take place, which would be more effective for consumers and businesses. 

And I am also pleased to see the mandatory country of origin labeling for food is included in the bill. I think in today’s environment, this is really essential information for consumers to know 

where their food comes from. This is a long and complex bill, and 

I too, along with my colleague Mr. Murphy from Connecticut, really 

want to salute those that have worked on this issue. 

Rosa Delauro has just been tireless, and you know that she 

brings passion and intellect to what she does. And so some of the 

ideas from her legislation are embedded in this. I look forward to 

our conversation. I hope that what we are asking the FDA to do 

that you are really up to it. 

I think we have lived on fees for a long time, and I still have 

questions and would like to know directly from you whether you 

really think you are going to have the resources that are necessary 

to do this. Because if you don’t, then the print of the legislation or 

law would be wonderful to read like some constitutions around the 

world that are absolutely magnificent, but they are not worth the 

paper they are written on. 

We have fallen off the edge of a cliff in terms of what is coming 

into the country and what has happened to the American people. 

We have to get this right this time. And some think that there 

should be a stand-alone food inspection agency. Can the FDA actually do all of this? Do you have the resources for it? 

I mean if there is pizza that has pepperoni on it versus pizza 

that doesn’t have any meat on it, should there be a split jurisdiction between agriculture and the FDA in terms of inspection? I 

think the more splits there are, that there is more of an opporVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
38 

tunity for things to fall between the cracks. I may be entirely 

wrong, but I still have some questions. 

I don’t think this is a perfect piece of legislation, but I am sure 

glad that we are considering the issue. So I wish you nothing but 

the best. I have great, great confidence and respect for you, and I 

am very proud that the President chose to pick the best in the 

country for this job. Thank you. 

[The prepared statement of Ms. Eshoo follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
39 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 44 here 73752A.010
40 

Mr. PALLONE. Thank you. Gentlewoman from Illinois, Ms. Schakowsky. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman, and congratulations, Dr. Hamburg. I come to this issue with a lot of history and 

also this particular issue with a lot of emotion. My good friend 

Nancy Donnelly whose only child Alex was lost because of eating 

hamburger with E. coli and then dedicated her life to creating an 

organization, Safe Tables are Priority, has worked tirelessly for 

food safety. 

And year after year, we have people coming before us telling 

these devastating stories, and every time we say we are going to 

do something so it never happens again. And yet it does. 

In February, we heard testimony from Peter Hurley whose young 

son was made ill by eating Austin peanut butter crackers. They 

were found in millions of homes, and we were all shocked by documents presented at that hearing that showed that the Peanut Corporation of America knew that their products were tainted and yet 

released them into the food supply anyway. 

So the discussion draft that is before us includes provisions that 

will seriously fill many of the gaps in our current food system. I 

wanted to just mention a couple of things that I think ought to be 

considered for review. There is just a brief mention in the bill dealing with the issue of antibiotic-resistant pathogens and the extent 

to which antibiotics that are used in livestock contributes to this 

resistance. We don’t always think about this as food safety, but I 

think it is a truly important issue with H1N1. I know it was a 

virus, but nonetheless everybody is waiting for that kind of a 

plague that we don’t have the care for partly because of antibiotic 

resistance. 

Second, I believe the companies who have positive test results for 

possibly dangerous contaminants should be required to report those 

results to the FDA. We heard how PCA, nobody knew about it, and 

I think there are many other examples. It is a question on how the 

FDA effectively can ensure the safety of our food if we don’t even 

know where there might be a problem. 

And finally I believe the collecting and disseminating of information about food safety and food-borne illness to consumers is a critical component of any food safety plan. I am encouraged by the provisions of the bill, but I think there may be more that we can do 

to ensure that Americans are adequately informed. Thank you so 

much. 

Mr. PALLONE. Thank you, and I believe that completes our members’ opening statements. So we will now turn to our witness. And 

let me say, Dr. Hamburg, I appreciate your being here. I want to 

welcome you. We have, as you know, five-minute opening statements that become part of the record, and then you may get some 

questions afterwards from members of the committee. So thank you 

and if you would begin. 


srobinson on DSK4SPTVN1PROD with HEARING
41 

STATEMENT OF MARGARET HAMBURG, COMMISSIONER, FOOD 

AND DRUG ADMINISTRATION 

Dr. HAMBURG. Chairman Pallone and members of the subcommittee, I am Dr. Margaret Hamburg, commissioner of the Food 

and Drug Administration. Thank you for the opportunity to appear 

before you today to discuss the urgent need for reform of our Nation’s food safety system. I commend you, Chairman Waxman, 

Chairman Stupak, Chairman Emeritus Dingell, and other members 

of the committee and your staffs for your leadership and hard work 

in developing this draft legislation. 

The food safety bill under consideration represents significant reforms needed to modernize our food safety system. I am honored 

to have been chosen by President Obama to lead this great agency, 

and I am inspired by the President’s personal commitment to improving food safety, including the progress being made by his food 

safety working group. 

The President has backed up his commitment with resources, 

proposing historic increases in funding for FDA’s food safety efforts. I also appreciate the support of Secretary Kathleen Sebelius 

and the Department of Health and Human Services and of Secretary Tom Vilsac and the U.S. Department of Agriculture for 

major progress on food safety. 

In addition, a coalition of consumer groups is fighting for improvement in the food safety system so that more families do not 

have to suffer tragic consequences from food-borne disease. Major 

sectors in the food industry also support and are advocating for 

fundamental change, but even with all this support and momentum, our efforts will fall short unless Congress modernizes food 

safety laws to deal with the challenges of the 21st century. That 

is why this hearing is so important. 

From the perspective of FDA, there are three key questions to 

ask about food safety legislation. First, does the legislation support 

a new system focused on prevention? Second, does the legislation 

provide FDA the legal tools necessary to match its existing and 

new food safety responsibilities? And third, does the legislation provide or anticipate resources for the agency to match its responsibilities? 

To comment on the discussion draft, let me address each of these 

issues in turn. The first, does the legislation support a new food 

safety system focused on prevention? The draft legislation would 

indeed transform our Nation’s approach to food safety from responding to outbreaks to preventing them. It would do so by requiring and then holding companies accountable for understanding the 

risks to the food supply under their control and then implementing 

effective measures to prevent contamination. 

Does the legislation provide FDA the legal tools necessary to 

match its existing and new responsibilities? In a new food safety 

system, FDA has the fundamental responsibility of overseeing and 

verifying the implementation of preventive measures by hundreds 

of thousands of companies. The agency also retains the existing 

critical role of protecting the public during an outbreak. FDA needs 

new legal authorities to be able to succeed in these roles and protect the public health. This legislation would provide these critical 

tools. 


srobinson on DSK4SPTVN1PROD with HEARING
42 

My written testimony provides several examples, but I would like 

to highlight one of the most important new authorities now. Section 106 provides FDA with explicit authority to access food records 

during routine inspections, thereby addressing one of the most significant gaps in FDA’s existing authority. The authority provided 

in this provision is essential to enable FDA to identify problems 

and require corrections before people become ill. 

It also enables the agency to verify, during routine inspections, 

that firms are maintaining proper distribution records. Records access and record keeping by all persons in the distribution chain are 

the key mechanisms of providing regulators with information on 

plant operations, product safety, and product distribution. Such information is necessary to verify compliance and to identify problems. 

Lastly, does the legislation provide or anticipate resources for the 

agency to match its existing and new responsibilities? The draft 

legislation makes an important investment in the resources needed 

for major progress. After all, FDA must have the resources necessary to meet its responsibilities. Otherwise, the public will not 

benefit from the promise of a modern food safety system, and the 

agency will fail to meet the expectations of the President, Congress, 

and the public. 

The bill authorizes three fees that are also requested in the 

President’s fiscal year 2010 budget. One of these is in Section 101, 

which provides for a registration fee. This fee is of critical importance to enable the agency to improve and expand its food safety 

activities, including to increase its inspection coverage of the approximately 378,000 registered facilities and to enhance its other 

food safety activities. 

Section 105 proposes a rigorous inspection schedule for food facilities. These requirements start 18 months after the enactment. 

To meet these requirements, Section 105 allows the agency to use 

inspections conducted by inspectors from recognized state, local, 

other federal agencies, and foreign government officials. 

FDA would like to raise three issues about Section 105. First, the 

amount of resources required to achieve these inspection goals 

would far exceed even the historic increases in the President’s fiscal year 2010 budget. Moreover, it would be difficult, if not impossible, for FDA to hire and train thousands of additional staff so 

quickly, even while relying on inspections by state, local and other 

federal and foreign government officials. 

As a result, FDA encourages the committee to modify this section 

to take into account the operational and resource challenges involved. 

Second, as we develop a new food safety system, FDA will gain 

better information to guide the agency’s approach to inspection and 

oversight. We will understand where we must inspect more frequently because of the high risk of certain foods, facilities, and 

processes, and understand where we can protect public health 

without conducting inspections as frequently. 

As a result, FDA would support flexibility to modify the inspection requirements based on the best available data on risk. 

Third, Section 105 could do more to provide flexibility to FDA in 

meeting the inspection challenge. The draft legislation allows the 


srobinson on DSK4SPTVN1PROD with HEARING
43 

agency to rely on inspections by other federal agencies as well as 

by state, local, and foreign governments. An additional promising 

mechanism for international inspections is certification by accredited third parties. FDA would like the flexibility to explore the use 

of such an accreditation system and audit the performance of accredited third parties. With strong standards and robust oversight 

by FDA, this approach could help address the oversight challenge 

posed by the more than 220,000 registered foreign facilities exporting to the United States. 

This is a historic moment for food safety in the United States, 

a moment for FDA and its sister agencies in the federal government to rise to the challenge of the 21st century. Success means 

fewer hospitalizations and deaths, fewer devastating recalls, and 

greater health for the American people. 

The draft legislation is a major step in the right direction. I commend the committee for its leadership, and on behalf of the hundreds of dedicated staff devoted to food safety at FDA, I look forward to assisting with the legislative process. I welcome any questions you may have. 

[The prepared statement of Dr. Hamburg follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
44 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 49 here 73752A.011
45 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 50 here 73752A.012
46 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 51 here 73752A.013
47 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 52 here 73752A.014
48 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 53 here 73752A.015
49 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 54 here 73752A.016
50 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 55 here 73752A.017
51 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 56 here 73752A.018
52 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 57 here 73752A.019
53 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 58 here 73752A.020
54 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 59 here 73752A.021
55 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 60 here 73752A.022
56 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 61 here 73752A.023
57 

Mr. PALLONE. Thank you, Dr. Hamburg. We will have a series 

of questions now from the members. Each of them gets five minutes, and I will start with myself. Under the bill, all facilities, both 

domestic and foreign, seeking to market food in the U.S. must register each year and provide certain information about the facility 

to the FDA. If the facility is not registered, it is illegal to market 

food from that facility in the U.S. And in order to register, each facility would be required to pay $1,000 per year as a registration 

fee. 

Now, my understanding is in 2002, there was bioterrorism legislation, and under that legislation, food facilities were required to 

register, but there was no requirement to update that registration. 

So my questions reference that registration under the 2002 bill. 

Has that system resulted in problems in terms of FDA’s ability to 

accurately account for all facilities selling food in the U.S.? And 

maybe you can tell us what problems exist. 

And then the second part is do you believe that linking a fee to 

the requirement to register would help address whatever problems 

exist under this system that dates back to that 2002 bioterrorism 

legislation? 

Dr. HAMBURG. Thank you. I think it is clear, based on the experience since the bioterrorism act in 2002, that we do need the extended authorities that would be offered in this bill. We know that 

when a facility registers once but doesn’t have to register again, 

that it does create problems in terms of our ability to fully understand the nature of the food-related activities in that facility. 

The Peanut Corporation of America, I think, is one good example. 

When they first registered, they weren’t actually making peanut 

butter, and then they added that to their activities. With annual 

registration, we would have a much better record and understanding of the activities. And it would provide us with the tools 

to be more responsible in our oversight and in our inspections. 

With respect to the issue of fees, I think it is a very important 

component of any food safety plan that Congress would enact. We 

absolutely need to have the resources to do our job. I understand 

that fees represent a burden on companies, and I wish that we 

were not dependent on that mechanism in all cases. But I do think 

that that fee is an investment in a robust and effective food safety 

system. That fee will go to enable the FDA to provide certain specific services and put in place the board and modernized food safety 

system that American consumers expect and need. 

Mr. PALLONE. All right, let me go back to this fee because in the 

President’s budget, he asked for $75 million in registration and reinspection fees. So obviously the administration has already shown 

support for the concept of a registration fee for food facilities in the 

budget. 

However in our bill, with its $1,000 per facility fee, we would 

generate much more than the $75 million that is in the President’s 

budget. So I want you to explain, if you could, what was contemplated in the President’s budget request of the $75 million. Did 

that request seek to address the new authorities provided in this 

bill? 

Dr. HAMBURG. Well, the President’s budget request was, of 

course, put together before the specifics of this proposed legislation 


srobinson on DSK4SPTVN1PROD with HEARING
58 

was put forward. So it wasn’t addressing all of the specific requirements laid out in this bill, importantly including the inspection 

schedule. 

In my written testimony, there is an appendix that actually lays 

out some of the food safety highlights in the President’s bill and 

some of the targeted areas for that $75 million increase in the 

budget. 

It was to include many elements that are a part of this legislation, increased inspections but not to the degree that this legislation would call for, the implementation of preventive controls, 

strengthened laboratory testing, a stronger integration of FDA and 

federal food safety efforts with the state and local activities which 

is ultimately very, very essential to the—— 

Mr. PALLONE. Well, I know that the bill allows these fees to be 

applied towards a broad array of FDA’s food safety activities. You 

know, in other words, it allows the fees to be used to boost FDA’s 

ability to develop standards like performance standards and preventive controls. Do you agree that the fees should be applied towards all these activities that we mention in the bill? 

Dr. HAMBURG. I think we want a robust, comprehensive program, 

and those fees should be applied to putting in place that suite of 

activities. The preventive controls are directly related to what companies must do under the new legislation, and I think it is very appropriate that the fees cover that aspect. For example, the inspections obviously are directly related. Very important that the fees 

cover that aspect and many other aspects of the portfolio of activities outlined in the legislation really are essential to what needs 

to be done to protect consumers and ultimately to protect the food 

industry. So that the public and consumers can be assured that the 

products are safe. 

Mr. PALLONE. Thank you. Thank you very much. Mr. Deal. I am 

sorry. Mr. Whitfield. 

Mr. WHITFIELD. Thank you. Mr. Deal had to leave. Dr. Hamburg, 

as you probably know, Senator Kennedy and Durbin and Burr and 

Greg have introduced a food safety bill on the Senate side. And has 

the administration endorsed that bill, or has it endorsed this bill, 

or has it endorsed any bill? 

Dr. HAMBURG. You know I have to be honest that I have not— 

I have only been on the job seven days, and I have been focused 

on your piece of legislation. 

Mr. WHITFIELD. OK. 

Dr. HAMBURG. And so I would be happy at a later time to discuss 

in more detail the bill on the Senate side. 

Mr. WHITFIELD. But as far as you know, the administration has 

not endorsed either bill? 

Dr. HAMBURG. I don’t believe so. 

Mr. WHITFIELD. OK. Well, the reason I brought that up, there 

are some significant differences in this Senate bill and the House 

bill. And one area of difference relates to recall authority of the 

FDA. And under this bill, the FDA would have the authority for 

recall if an article of food may cause adverse health consequences. 

That would be the legal standard, may cause. But in the Senate 

bill, it says that there must be a reasonable probability of serious 

adverse health consequences or death. So those standards are sigVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
59 

nificantly different, and I would just ask you, since you are now 

going to be responsible for this. That first standard that is in this 

bill seems so general and so nebulous in a way. Does that bother 

you? Don’t you think it would be better to have a more precise 

identified standard for recall? 

Dr. HAMBURG. Well, I certainly understand the concern that you 

are raising, and I think there may be some opportunities for some 

wordsmithing. Certainly we would never seek to recall a product 

without, you know, some reasonable expectation that there was serious adverse consequences and harm related to that product. A recall is no small issue both in terms of resources and efforts on the 

part of the FDA and also its implications on industry and consumers who want access to those products. 

So I think it is an area that we would like to work with you on 

for language. We wouldn’t want it to be too overwhelmingly prescriptive because you want to have the flexibility in that kind of 

potentially emergency situation to move forward. 

Mr. WHITFIELD. Well, I agree. I mean I think this is an area that 

we should look at because we know the ramifications of a recall, 

the expense involved, and certainly we want to have a balancing 

of protecting the public versus preventing undue expenses to companies as well. So I am glad to see that that is at least an area 

that you would be willing to talk about. 

I might also say the same thing would apply to the access of 

records. There really is no standard at all in this bill, but in the 

Senate bill, it says that if FDA has a reasonable belief that an article of food presents a threat of serious adverse health consequences 

or death, FDA would have access to and be able to copy all records 

and so forth and so forth. But under this bill, it appears that FDA 

would just have blanket authority to request any records at any 

time without any sort of standard being met. 

Dr. HAMBURG. Well, here I would like to stress that I think access to routine records is extremely important to assuring a safe 

food supply. It is very important that when inspectors go into a facility, they can examine certain aspects of what has been the procedure during a preceding period of time and not just inspect what 

is happening at that moment. Had we been able to better access 

routine records in the case of PCA, which has been talked about 

already this morning, we would have been able to see that there 

was documentation of contamination several years earlier, which 

had not been adequately addressed. 

Mr. WHITFIELD. My time has about expired, but I would like to 

ask just one additional question. It relates to Jan Schakowsky’s 

comment in her opening statement about the use of antibiotics in 

the agricultural community and the fact that more and more people 

seem to be establishing immunity to certain antibiotics. Is that a 

concern of yours? 

Dr. HAMBURG. It is a huge concern of mine in terms of the growing problem of antibiotic resistance in this country and around the 

world and the implications that it has for our armamentarium of 

antibiotics to address serious and life-threatening diseases. I think 

it is an area that merits a lot of attention by the FDA, working in 

partnership with others. It is a topic I would be happy to come 


srobinson on DSK4SPTVN1PROD with HEARING
60 

back and discuss in more detail with you. And it is very high priority for me in terms of overall goals to improve public health. 

Mr. PALLONE. Thank you. Chairman Dingell. 

Mr. DINGELL. Mr. Chairman, thank you. Welcome again, Dr. 

Hamburg. Congratulations. My first question, it will be a yes or 

no—well, inspections are an important part of finding and addressing food safety problems. Isn’t this correct? 

Dr. HAMBURG. Yes. 

Mr. DINGELL. Your agency does not have a good record when it 

comes to inspecting food facilities. Last year, you inspected 6,562 

food facilities in the United States, 152 foreign facilities in the 

same time. Was that enough inspections? How many should you 

have? And what resources would you need to do the job? 

Dr. HAMBURG. I think we can do better. With respect to the question of exactly how many, you know, I cannot tell you that now. 

But—— 

Mr. DINGELL. I will submit you a letter asking these questions 

in greater detail. 

Dr. HAMBURG. I was warned that you would do that. 

Mr. DINGELL. And I ask unanimous consent that the record remain open to include both my letter and the response of the administrator. 

Mr. PALLONE. So ordered. 

Mr. DINGELL. Would you support an increased frequency requirement? 

Dr. HAMBURG. We clearly need to do more frequent inspections. 

We also need to do smarter inspections, and we need not to rely 

simply on inspections as our tool for a safer food supply. 

Mr. DINGELL. We agree on that. I am keenly aware that there 

is a substantial cost associated with conducting foreign and domestic facility inspections. How much do you need to do this properly 

in terms of personnel and money? If you can’t give it now, I will 

ask the record be kept open to receive that. 

Dr. HAMBURG. All right, well it is a complicated answer, and 

there are some unknowables, but we need a lot more money. 

Mr. DINGELL. Mr. Chairman, I ask unanimous consent that the 

record remain open so that this can be inserted at the appropriate 

time. 

Mr. PALLONE. Mr. Chairman, the record will remain open. You 

don’t have to keep saying it. 

Mr. DINGELL. Thank you. And it is clear with new inspection requirements, FDA is going to need new additional resources to meet 

that requirement. Is it not? 

Dr. HAMBURG. That is absolutely true. 

Mr. DINGELL. The President has asked for additional resources 

for food safety activities at the agency. He requested, I am told, 

about $259 million in additional money. Is that correct? 

Dr. HAMBURG. Yes. 

Mr. DINGELL. It was the President’s intent that these additional 

dollars, amounting to $164.8 million in new budget authority and 

$94.4 million in new fees, registrations, re-inspection and export 

certification would be used for increasing the number of food facility inspections conducted by your agency. Is that not correct? 


srobinson on DSK4SPTVN1PROD with HEARING
61 

Dr. HAMBURG. It would be used for that as well as other components of a more comprehensive modernized food safety system. 

Mr. DINGELL. Thank you. It is correct that the President’s budget 

request for food safety activity did not include any new requirements that may come with the food safety legislation that we are 

considering here. Is that correct? 

Dr. HAMBURG. I am sorry, but could you repeat the question? 

Mr. DINGELL. The President’s request for new monies did not include monies to address the questions that you will be compelled 

to face under the new legislation. Is that correct? 

Dr. HAMBURG. It addressed some components but not the full—— 

Mr. DINGELL. But not all? 

Dr. HAMBURG [continuing]. Panoply of requirements that are outlined in this legislation. 

Mr. DINGELL. There are many who have resisted new money for 

improving food inspection frequency by the agency. They ask that 

the use of these dollars for such activity be prohibited. Would you 

agree with that or disagree? 

Dr. HAMBURG. I hate to do this, but this style of questioning—— 

Mr. DINGELL. I am sorry. I have limited time. 

Dr. HAMBURG. I know. 

Mr. DINGELL. I have 12 seconds left. 

Dr. HAMBURG. Could you just repeat the question? 

Mr. DINGELL. Question: Do you agree with the idea that we 

should prohibit the use of registration fees for inspection? 

Dr. HAMBURG. I think we need registration fees to enable the 

agency to do its inspectional activities and other components of a 

food safety plan. 

Mr. DINGELL. As a matter of fact, one of the few successful activities of Food and Drug at this particular time is what you do under 

PDUFA, which is supported by fees. Is that not correct? 

Dr. HAMBURG. That is correct. 

Mr. DINGELL. And you are starving in almost every other place. 

Isn’t that so? 

Dr. HAMBURG. Correct. 

Mr. DINGELL. Can you state with any certainty the number of 

people, importers, customs brokers, filers, who import products 

under FDA’s jurisdiction to the United States in any year? I believe 

the answer to that question is no. 

Dr. HAMBURG. Is no, and this legislation would enable us to get 

a much better handle on who is out there producing and distributing food for U.S. consumption. 

Mr. DINGELL. And the reason is that they are not currently required to register with FDA. Isn’t that the reason? 

Dr. HAMBURG. That is a large part of the reason, yes. 

Mr. DINGELL. Isn’t it important to FDA to have an accurate, upto-date accounting of who these people are? 

Dr. HAMBURG. Very important. 

Mr. DINGELL. Now, these individuals are not required to comply 

with certain requirements to ensure the safety of these products 

that they import. They can handle any type of FDA-related products and are not required to have any specific training to do so. Is 

that not correct? 


srobinson on DSK4SPTVN1PROD with HEARING
62 

Dr. HAMBURG. That is correct. We would like to make sure that 

individuals importing food into the United States followed standards and guidelines that we expect with domestic food production. 

Mr. DINGELL. Good. The discussion draft establishes a program 

to require importers, U.S. custom brokers of foods, drugs, and devices and others to register with the FDA and require that good 

importer practices are maintained as a condition for maintaining 

registration. Do you agree with that requirement? 

Dr. HAMBURG. We would like importers to be registered. 

Mr. DINGELL. Now, one more question, and then—well, I tell you 

what. I note my time is up. Madam Administrator, I will be submitting you a letter. Mr. Chairman, thank you for your patience, 

and I would thank my colleagues. I would note that the changes 

in the draft that we have before us today are those which have 

been largely done in consultation with FDA and in consultation 

with my minority colleagues. The next changes that you see will 

originate in about the same way. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Chairman Dingell. Next is the gentleman from Indiana, Mr. Buyer. 

Mr. BUYER. Thank you. In your statement, you support the 

FDA’s ability to trace foods more quickly during an outbreak, so 

you would support a track and trace system with regard to food. 

Is that correct? 

Dr. HAMBURG. I would. I think it is very important to our ability 

to respond quickly to outbreaks of concern. 

Mr. BUYER. And since you appear to be endorsing the bill, this 

draft discussion bill in front of us, you also support then the FDA’s 

ability to increase inspections of food processing facilities. Is that 

correct? 

Dr. HAMBURG. I think we need to do more inspections, but as I 

said earlier, I think we also need to recognize that it isn’t simply 

increasing the number of inspections that will get us to the food 

safety system that we need. But it is also instituting the preventive 

controls and really shifting the way we think about food safety and 

also, you know, stronger partnerships with the locals and foreign 

government. 

Mr. BUYER. Ma’am, when you discover a contaminated food, you 

believe it is your responsibility then to prevent the distribution of 

that contaminated food into the marketplace. Am I correct? 

Dr. HAMBURG. Yes. 

Mr. BUYER. So you are asking for that ability to do a recall. 

Would that be correct? 

Dr. HAMBURG. Yes. 

Mr. BUYER. And that once that contaminated food has been discovered, do you believe that you should have the ability to order 

the destruction of the contaminated food? 

Dr. HAMBURG. It depends on the specific circumstance. Sometimes with a contaminated food, it might be possible to reprocess 

it and make it available in a safe way. But it is contaminated and 

putting consumers at risk and such an option does not exist, then 

that food should not be allowed to be provided to consumers. 

Mr. BUYER. Since you support a federal tracking system for food, 

would you also be willing to support an electronic pedigree system 

for an interoperable tracking system for pharmaceuticals? 


srobinson on DSK4SPTVN1PROD with HEARING
63 

Dr. HAMBURG. You know I think that in both realms, it is very 

important to know where things came from—— 

Mr. BUYER. Is this yes? 

Dr. HAMBURG [continuing]. And where they are going. 

Mr. BUYER. Is this a yes? 

Dr. HAMBURG. Well, you know, I am reluctant to—— 

Mr. BUYER. You are going to choose contaminated lettuce over 

adulterated drugs? I don’t think so. 

Dr. HAMBURG. No, I am not. I didn’t think your question was either/or. I thought it was—— 

Mr. BUYER. My question is if you are going to support a pedigree 

system for the tracking and tracing of contaminated food, don’t you 

also believe that it is important for us to have an electronic pedigree for the tracking and tracing of pharmaceuticals? 

Dr. HAMBURG. In concept, I think, as I said, that traceability is 

very important to assure that what consumers get is—— 

Mr. BUYER. All right, let me get to this. We have 11 international 

mail facilities. Add three other mail facilities, DHL, UPS, and 

FedEx, of which 30,000 to 35,000 pharmaceutical packages come 

into those mail facilities every day. So do the math. When you do 

your inspections about 80 percent of them are either adulterated or 

they are counterfeit knockoffs. Yet FDA claims they do not have 

the ability to destroy. 

So you are sitting here before this committee today saying that 

you know believe that you should have increased ability to inspect 

and to go after this contaminated food. I want to make sure that 

you also believe that you should have the ability to destroy these 

counterfeit, knockoff drugs. Because if you just do the math, that 

has got to be in excess of 350,000 counterfeit adulterate, knockoff 

drug packages per day. That is millions of packages per year that 

are harming people. So let me go right to you. Do you believe that 

FDA should have the authority, equal authority, to destroy these 

counterfeit adulterated drugs? 

Dr. HAMBURG. As I indicated earlier, this is my seventh day on 

the job, and I haven’t been briefed in full on all these issues. The 

problem of counterfeit drugs is huge concern, and I am eager to 

work with you since you clearly care very much about it. 

Mr. BUYER. All right, you know what is happening right now? 

Here is customs, and right over here is FDA. There is not even a 

wall, yet customs has the ability to destroy. But you claim you 

don’t have the ability to destroy. Please don’t come before this committee and tell our country that you think we ought to be able to 

protect you with regard to food, but with regard to drugs, I can’t 

believe as a doctor you would say—— 

Dr. HAMBURG. And I am not telling you that, sir, but I am—— 

Mr. BUYER. Well, then be clear. 

Dr. HAMBURG [continuing]. Telling you that these are issues that 

are at the heart of the FDA mission and as a physician, extremely 

important to me. They are issues that I am determined to work on, 

determined to work with members of Congress to find appropriate 

solutions. But I am not comfortable at this time discussing the specifics of that program which I haven’t been fully briefed on. 


srobinson on DSK4SPTVN1PROD with HEARING
64 

Mr. BUYER. All right, ma’am, I will be willing to work with you 

because I can’t believe that this would be an issue that you would 

equivocate on. I yield back. 

Mr. PALLONE. Gentlewoman from Colorado, Ms. DeGette. 

Ms. DEGETTE. Thank you very much, Mr. Chairman and Dr. 

Hamburg. I want to add my welcome to that of my colleagues to 

your appointment. I know you are going to be working with this 

committee on a lot of different issues. 

I want to talk to you about the trace back system because we 

have worked very closely over the years and most particularly on 

this latest iteration of the legislation on setting forth mandatory 

characteristics that would be contained in the tracing system that 

the FDA sets up through the regulatory process. 

For example, the bill requires that the origin and previous distribution history of food must be maintained, and that history must 

be linked with the subsequent distribution history of the food. And 

it also requires—to me this is a really key component—that the 

system be interoperable. So for different types of food, they can figure it out. 

Some people question whether it will ever be feasible to implement this type of system, and I am wondering if you can give your 

opinion on the feasibility of this type of a trace back provision. 

Dr. HAMBURG. Well, as you indicated, it is very, very important 

and key to our success in being able to respond swiftly to outbreaks 

and make the appropriate interventions to protect the American 

public. Interoperability is absolutely key because it involves a 

whole range of different players along the full life cycle of the product, and that is one of the great challenges. 

I think as we move forward in developing and implementing a 

traceability program, we need to work very carefully with industry 

and with the different components of the food production system. 

We need to do it in the context of public meetings and open exchange, but that should be our goal absolutely. 

Ms. DEGETTE. And in the draft legislation, that is exactly what 

we do is we give the FDA the authority to work with industry and 

consumer groups to develop both the specific types of traceability 

technology and also the interoperability, correct? 

Dr. HAMBURG. Yes. 

Ms. DEGETTE. In other words, we are not saying—different sectors of the food industry have different types of traceability requirements, and we are not saying that we have a one-size-fits-all, correct? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. Do you think that there is an economic case to be 

made to the industry for better traceability? 

Dr. HAMBURG. I think absolutely because with the opportunity to 

really do adequate trace back, we can really target what are the 

components of a food or the specific food products that are causing 

the problem and remove those or put in place the interventions to 

decrease the risk to that particular component of the food life cycle. 

In that way, we can both save lives and reduce illness. 

But I think also reduce the cost to companies who, as we have 

heard about this morning, you know, have occasionally been inappropriately targeted when the trace back was inadequate and we 


srobinson on DSK4SPTVN1PROD with HEARING
65 

didn’t identify the correct product. And also when there is a whole 

industry, but there is only one processor or manufacturer that is 

the problem, then we can protect the rest of the industry by really 

honing in on the particular product at risk. 

Ms. DEGETTE. And once we develop this system, it should also 

make identification and removal of the specific contaminated food 

much more speedy than it has been—— 

Dr. HAMBURG. Absolutely. 

Ms. DEGETTE [continuing]. Which again benefits consumer 

health, and it benefits the economic interests of that sector. Just 

one last question. The draft legislation that we have prepared exempts farms that sell directly to consumers or to restaurants from 

the traceability requirements, the farmers markets and so on. Do 

you think that that is an appropriate carveout for them? 

Dr. HAMBURG. I think that we have to recognize the burdens on 

smaller businesses, but we also, from a public health point of view, 

have to assure that when there is a problem we can get access to 

the information that is needed to identify the source of a contaminated food. So we need to work very closely with—— 

Ms. DEGETTE. You know one thing is that these farmers markets, for example, they are not broadly distributing their food. It 

is just local. So if someone did get sick, the state health department could easily trace it back. 

Dr. HAMBURG. It certainly makes it easier to do the outbreak investigation. 

Ms. DEGETTE. Right. Thank you very much. 

Mr. PALLONE. Thank you. Gentleman from Illinois is ready? 

Mr. SHIMKUS. Thank you, Mr. Chairman. Mr. Chairman, can I 

ask you a process question first? 

Mr. PALLONE. Sure. 

Mr. SHIMKUS. Is there a possibility that the subcommittee may 

consider this legislation next week? 

Mr. PALLONE. Yes. 

Mr. SHIMKUS. And if so, I would ask then if members who could 

submit questions for the record by the close of business tomorrow, 

could we have witnesses respond to those questions by the close of 

business Monday? 

Mr. PALLONE. Sounds like a good idea to me since we are likely 

to mark up next week. You have no problem with that? 

Dr. HAMBURG. I think that is very appropriate approach. 

Mr. PALLONE. OK. 

Mr. SHIMKUS. And we do know—— 

Mr. PALLONE. Without objection, that is what we will do. 

Mr. SHIMKUS. We know that is challenging, but, of course, this 

is a draft as I said in the opening statement. So we appreciate that. 

And again we do appreciate your testimony and welcome on board 

and we are all working for really on the same team trying to get 

responsible legislation that protects human health while ensuring 

that fees go to where fees need to go. So I just have two. 

One, and this goes back in history. Two decades ago when Congress was deliberating on how to improve the state clinical laboratory testing—and I have been in the lab tech issue a lot—this committee under the leadership of now Chairman Emeritus Mr. Dingell, Mr. Waxman, and my own former colleague Mr. Madigan 


srobinson on DSK4SPTVN1PROD with HEARING
66 

issued a conference report stating that proficiency testing is considered one of the best measures of laboratory performance and arguably the most important measure since it reviews actual test results rather than merely gauging the potential for good results. 

As we examine the discussion draft and its call for accreditation 

standards for laboratories to perform analytical testing on food, in 

your opinion, should proficiency testing be explicitly included here 

too? 

Dr. HAMBURG. I think that we would only want to work with accredited labs, and the accreditation process addresses those kinds 

of concerns. The accuracy of the testing is key to making the right 

decisions, and, you know, I think that as we move forward, laboratory testing needs to be a strong component of what we do. And 

so efforts to ensure the accuracy of testing results is absolutely key 

to protect businesses and to provide the public health system with 

the information it needs to take action on. 

Mr. SHIMKUS. And I would agree with that. I think that is as 

close to a yes as I will get, and that is fine. But I think that is a 

critical component if we are going to do this, that the proficiency 

test be a process by which we, you know, test the tester so we have 

some certainty. 

Let me go back, and I know we have talked about this $75 million in the President’s budget and $375 million in revenue. I mentioned this in my opening statement before some of the discussion, 

and I understand that, you know, this legislation offers more authority. And so that is why there may be a differing number than 

what the President proposed. 

But I think a lot of us are going to be challenged by the fact— 

and what would be helpful before we move to markup is, you know, 

show us the money. Show us where we came up with this amount. 

As I have said also, there has already been millions of dollars put 

into food safety over the past six months. 

A lot of us are trying to understand where $375 million came out. We understand that there was $1,000 per facility, and you add 

up the facilities, you get $375 million. But that doesn’t answer the 

question as to where is that money? Is that money going to go to 

an inspection regime? And what does it cost to do an inspection regime? 

I have been really a strong spokesperson for a risk-based system. 

Now, the risk-based system promoted in this draft legislation in nowhere near what I believe a risk-based system should be. I think 

you should go after risky individuals. And facilities that in essence 

offer no risk, you ought to incentivize them, and this has been 

statements that I have made for a long time. So I think even this 

risk-based approach that we are saying can be modified somewhat. 

So is there a way to get up a better handle, or do you have better numbers that support this discussion draft that $375 million actually means $374 million more dollars worth of ability to inspect? 

Dr. HAMBURG. Well, regrettably, I don’t believe that the $375 

million will cover the costs of inspecting on the schedule outlined 

in the bill. We actually would need considerably more resources to 

do that. We know, you know, based on—estimates vary, but that 

domestic inspections cost a little over $9,000. International inspections are probably threefold higher, and the number of facilities reVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00072 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
67 

quiring inspection are very, very large, numbering in the hundreds 

of thousands. The numbers add up quickly. 

Mr. SHIMKUS. And my time has expired, and I apologize. I would 

just say that there is going to be skeptics that say OK, we have 

$375 million on a fee schedule, and it is not going to go for inspection. 

Dr. HAMBURG. It will go for inspection. 

Mr. SHIMKUS. It will go to other aspects of the FDA, and it would 

help provide some clarity. And, Mr. Chairman, if I could just end 

on this because the chairman emeritus mentioned this once again 

that there has been negotiation with his Republican colleagues. I 

would call them information positions of the answer of no. Not really negotiations on addresses of the bill, and I would encourage, 

maybe this is going to be a member-member discussion. But if we 

want a bipartisan bill, we ought to have some just not dictates, this 

is what we are going to do, but this is where we need to work together. And I yield back my time. 

Mr. PALLONE. Thank you. Let me just reiterate again what Mr. 

Shimkus suggested in terms of the questions. We are going to ask 

the witnesses, including you in the next panel, and I will not remind the next panel that they submit their questions—the members submit question by the end of tomorrow night, which would 

be Thursday night and that we have responses by the end of business day on Monday, OK. I will mention that again. I mean I don’t 

know. It may be difficult to meet that schedule. 

Mr. SHIMKUS. Yes, would the chairman yield? And we understand that is a lot to ask, but for us to move, I think it—— 

Mr. PALLONE. Yes, that is fine and—— 

Dr. HAMBURG. No, we are happy to comply with that. We appreciate that you are taking this—— 

Mr. PALLONE. OK. 

Dr. HAMBURG [continuing]. So seriously and wanting to move it 

forward swiftly. 

Mr. PALLONE. All right, thank you. Gentlewoman from California, Ms. Harman. 

Ms. HARMAN. Thank you, Mr. Chairman. I have sat here for a 

few hours listening to this hearing, and I think the content is very 

important. And I do think this committee has developed an enormous record on this subject. This is not new information for members of this committee, and I do think we will be able to move legislation next week. And I hope it will be bipartisan, and I agree with 

Mr. Shimkus that there should be opportunity for the other side to 

participate. 

I wanted to acknowledge a comment that Mr. Buyer made before 

he left the hearing room. He was in some fashion implying that Dr. 

Hamburg is not focused on drug safety. My response to that is of 

course she is. She has been here for 10 minutes and the first topic 

up is food safety, so let us give her and this committee time to 

focus on that subject in the near future and not be accusing each 

other in some way of perhaps inadequate attention. 

On the subject of food safety, which is what we are talking about, 

there is a section in the legislation about testing by accredited labs. 

Last year, I recall a huge worry about whether the prior administration was going to cut back on the number of accredited labs and 


srobinson on DSK4SPTVN1PROD with HEARING
68 

the impact that that would have on major ports of entry like the 

ports of Los Angeles and Long Beach. My district happens to be 

there. That are the place where enormous amounts of imported 

food enter the country. 

So I just want to give you a chance, Dr. Hamburg, not in terms 

of a yes-and-no answer session, but could you assure us that lab 

capacity is a priority of yours and assure us that there will be adequate lab capacity for the anticipated importation of food and for 

the standards in this legislation to work? 

Dr. HAMBURG. Absolutely. Laboratory testing is an essential component of a strong, science-based food safety system. And we do not 

have any plans to restrict our laboratory capacity. And I think, you 

know, as we move forward, we will want to make sure that we are 

applying the best possible science, including laboratory science, to 

our testing and screening activities. I hope that there will be advances in laboratory science and technology that will enable us to 

do our inspections in a more efficient and cost-effective way. But 

it is a pillar of what we do, and we will continue to support it. And 

we may, as resources become available and needs suggest, actually 

expand our capacity. 

Ms. HARMAN. Well, I appreciate that, and I am not suggesting 

that our current lab structure be frozen in time. Obviously if there 

are improvements either in location or in function, we ought to embrace that. 

But another one of the concerns that has been expressed is the 

ability to get the results from the lab to the FDA in a timely manner. Do you think the current system is adequate in that respect, 

and are you thinking about improvements to that? 

Dr. HAMBURG. Well, we are eager to implement a system for reportable foods that will include laboratories reporting positive tests 

to FDA, and I think that will be a very important additional element to our activities. 

Ms. HARMAN. Good. Well, I appreciate that too. Obviously in 

light of some of the recent outbreaks and their devastating impact 

on human life and health, it is important to get that information 

out and accurate as soon as possible. 

Mr. Chairman, I don’t have further questions of the witness. I 

am just thrilled that she is here. I yield back. 

Mr. PALLONE. Thank you. Gentlewoman from the Virgin Islands, 

Ms. Christensen. 

Ms. CHRISTENSEN. Thank you, Mr. Chairman, and I think your 

time is almost up. Thank you for your patience with all of the questions and listening to all of our opening statements. 

In your testimony, you reference Section 106 that provides the 

more explicit authority for FDA to access food records during inspections. Do you think that that is enough, or should we go further in the legislation to mandate that those records be forwarded 

to FDA? 

Dr. HAMBURG. You know I think what is outlined in the legislation is certainly a very good starting point. We don’t want to be inundated with information. We don’t want to put too much of a burden on industry, but we do need that access to records. We need 

companies to keep appropriate records, and we need to be able to 

have it to be able to inform our routine inspectional activities, to 


srobinson on DSK4SPTVN1PROD with HEARING
69 

be able to work with the companies to make sure that they have 

adequate preventive controls in place. And we need it certainly in 

the event of a serious outbreak of public health concern to enable 

us to swiftly get the information we need for action. 

Ms. CHRISTENSEN. So you think that requiring them to have 

their plans and to have their plans audited in conjunction with 

your authority to have access to the records should be sufficient? 

Dr. HAMBURG. You know I think we would want this to be a dynamic process as we learn more, putting in place the programs and 

policies and then learning from experience. But I think the bill lays 

out a very sensible and doable approach. 

Ms. CHRISTENSEN. OK, and you also talk about the huge task of 

hiring and training inspectors. And if I understand correctly, you 

are asking for some more flexibility in the legislation to be able to 

do that. Are you asking for general flexibility, or would a transitional timetable with times certain in the legislation work just as 

well? 

Dr. HAMBURG. Well, I think we just have to recognize that this 

would be an enormous scale-up of activity and that we need the 

timeframe to enable us to do it right, to recruit the people and 

train the people to work with industry to develop the systems that 

work. So we like flexibility in that way, and we would like more 

general flexibility so that we can learn as we go in terms of the 

inspection schedule and some of the requirements in that regard. 

Ms. CHRISTENSEN. OK, my last question is kind of a general one. 

I don’t think it was asked before, but even as late as yesterday, 

someone asked the secretary the question about one single entity 

to secure food safety with the authority over the food safety program for the country. 

I don’t think the secretary supported it. I am sure you don’t support it, but what can you say about, if you have had a chance to 

look at how FDA and USDA work together or don’t work as well 

together as they should? What can you say about addressing the 

concerns that give rise to the legislation that would put it in a single entity? 

Dr. HAMBURG. Well, a couple of responses to your important 

question. One is that clearly as the new FDA commissioner, I have 

a first and urgent priority to strengthen food safety within the FDA 

and I think that there are many things that we can do to strengthen our program to improve accountability, to raise the issue as 

high priority. Part of strengthening food safety within FDA is 

strengthening coordination with critical partners as well, and that 

certainly means with USDA, and I look forward to a working relationship with them. 

It also means strengthening the working partnerships with state 

and local public health organizations, and it very importantly also 

involves working with other international agencies and foreign governments because I think we are going to see the percentage of 

food coming in from overseas increasing in the years to come. And 

the globalization has a profound impact on the work of the FDA. 

And I also do think that the authorities and tools that this new 

draft legislation could potentially provide to the FDA will be extremely important in moving the federal government and the FDA 


srobinson on DSK4SPTVN1PROD with HEARING
70 

in the direction that we need to for robust and modernized food 

safety system. 

Ms. CHRISTENSEN. Thank you for your answers. Thank you, Mr. 

Chairman. 

Mr. PALLONE. Thank you. Gentlewoman from Ohio, Ms. Sutton. 

Ms. SUTTON. Thank you, Mr. Chairman, and thank you very 

much, Dr. Hamburg, for your service and for all that I am confident you are going to do to improve food safety in this country. 

As I mentioned in my opening statement, Ohio has been hit hard 

by issues arising from food safety. In the past year, there have 

been 105 cases of salmonella reported in Ohio and sadly three 

deaths resulting from the most recent peanut-based strain. 

Nellie Napier was a constituent of mine who unfortunately died 

from salmonella poisoning that she contracted in a nursing facility, 

and just in April of this year, in Cuyahoga County there were three 

incidences of illness from E. coli and another death, this time a 

seven-year-old girl. So this is an urgent issue for the people that 

I am so honored to represent. 

I mentioned that I introduced the Protect Consumers Act, which 

was a bill that would give the FDA mandatory recall authority, and 

I am happy to see that it is a part of this comprehensive bill. And 

I would just like to get a little bit more of your opinion about the 

need for recall authority. And this bill, of course, seeks to remedy 

the situation of the FDA not having the mandatory recall authority 

by laying out two different types of recall authorities. 

First if the FDA believes that a certain food may cause adverse 

health consequences or death, the FDA can require a recall. But in 

that scenario, FDA must first give the company an opportunity to 

voluntarily recall its own products. And if that doesn’t work, then 

the FDA can order a mandatory recall. 

And then, of course, the second type of recall is an emergency recall if the FDA finds that a certain food presents a threat of serious 

adverse health consequences or death. You may do that immediately. 

Can you just tell me about whether you think that the need and 

the approach, the two-tiered approach, is addressed in a good way 

in this bill and why it makes sense? 

Dr. HAMBURG. Well, I think the history is that voluntary recall 

is often effective in getting those potentially harmful products off 

the shelves and protecting consumers but that you do need that 

emergency mandatory recall function as a backup. There certainly 

have been cases where the mandatory recall of a dangerous product 

has been delayed because of a reluctance on the part of the company to pull that product, and there has been a back-and-forth and 

lawyers involved and delays of weeks, putting consumers at risk. 

So I think that to have the mandatory recall as a emergency 

measure is very, very important. And sadly in a world where we 

might also need to address intentional contamination of food, that 

emergency mandatory recall becomes a very, very important tool. 

You know I think the reality is that having that as an enforcement 

tool probably makes it easier to also work with companies on the 

voluntary recall. 

So I think it is a continuum that we need. We need both. 


srobinson on DSK4SPTVN1PROD with HEARING
71 

Mr. SHIMKUS. Will the gentlelady yield just on this same point, 

just a follow up on this? 

Ms. SUTTON. I have very little time, but I will yield. 

Mr. SHIMKUS. Yes, just to follow up. One of the issues would be 

may cause. That is kind of a low standard. I think there is going 

to be concern about the may cause language in here and how do 

you define that. 

Dr. HAMBURG. Yes, well we discussed that earlier, and I think 

perhaps there is some wordsmithing that could be done on that 

point. 

Mr. SHIMKUS. Thank you. I thank my colleague. 

Ms. SUTTON. Sure, and if I could just follow up on the suggestion 

that has been made and some have argued that because mandatory 

recall is such a strong tool that only the commissioner should be 

able to exercise the authority to order a recall with no further delegation. And I just wanted to know about your thoughts on the approach of having only the commissioner order a recall and how that 

would work for the FDA. And frankly, while I am at it, would such 

an approach work with regard to suspensions and subpoenas, and 

what are your thoughts about those subjects? 

Dr. HAMBURG. Well, these are important and powerful authorities that shouldn’t be used lightly. However, I think that experience shows that senior level officials can be entrusted with these 

authorities along with the commissioner, but it is certainly something that we would want to work with Congress on in order to put 

in place the system that people have the most confidence in. 

Ms. SUTTON. I thank you, and I am certain that we share concerns about expediency and making sure things happen in a quick 

time. And I think that your answer on the way that the recall authority would work, you having the mandatory authority would 

give you an opportunity to encourage even more strongly—or they 

would be necessarily encouraged, the companies, to comply on their 

own as well. So thank you very much. 

Mr. PALLONE. Thank you. Mr. Green. 

Mr. GREEN. Thank you, Mr. Chairman, and again, Dr. Hamburg, 

appreciate your patience today in—but if you think this is tough, 

you have FDA to work on, which is—and I laugh because in ’07 we 

spent a great deal of our time, both in the subcommittee and the 

full committee, in reforming FDA. And then last year with all the 

food safety issues that came up, it seemed like we are back at it 

again, and I am glad you are there. 

In my opening statement, I mentioned my concerns about the location and number of FDA labs, and I know my colleague from 

southern California, Congressman Harman, mentioned the same 

thing. Texas does have the longest running border with Mexico, 

and the port of Houston is right behind the port of LA/Long Beach 

in imported tons of food, yet we don’t have an FDA lab. And I have 

had the honor of meeting my FDA inspectors on the docks of the 

port of Houston, but they are detailed out of Laredo, Texas. 

And I guess because it is such a large state and the need for a 

lab somewhere, I am glad the bill does include the ability to contract with labs because we want the inspections done as quick as 

possible. Does the FDA tend to evaluate the current locations of the 

13 labs and whether these locations are meeting the inspections deVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00077 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
72 

mands? But also in the President’s budget, talks about three highvolume FDA labs, and how would the FDA decide where to place 

these labs? And what consideration would be placing in a place like 

Texas or even southern California? I didn’t know southern California didn’t have a lab with LA/Long Beach. And that is my only 

question. So thank you, Mr. Chairman. 

Dr. HAMBURG. Well, you know, I am fascinated that the laboratory issue comes up so much here because it is such a key issue. 

And in my past experience as a public health official, it is often the 

laboratory that is the underappreciated component of public health 

needs. So this is very encouraging to me. 

At the present time, we don’t have any plans to expand that 

basic, you know, network—— 

Mr. GREEN. Thirteen labs. 

Dr. HAMBURG [continuing]. Of laboratories that you mentioned. 

Although, as I said to Congresswoman Harman, you know, with additional resources and expanding need, that might be a possibility. 

We will be creating some additional high throughput laboratories. 

And in all honesty, I am not certain about the process by which 

those laboratories are being developed and cited. It is something I 

need to go back as a very new FDA commissioner and learn more 

about. But the laboratory issue is one that is essential as we have 

discussed. 

Mr. GREEN. I guess the reason it comes up so often is it, over 

the last three years actually, our committee has spent so much 

time on, you know, pharmaceutical safety, food safety, and the concern is that we are importing so much of our food. Like I said, Laredo, Texas is probably the biggest land-based port in the world. 

And so much food comes from Mexico we need the inspections as 

timely as possible to move the produce or whatever the products, 

the foodstuffs particularly. But we also need to make sure that it 

is—and the problem is it is not paid for. But with this fee that is 

going to be assessed, hopefully that will generate the resources, 

both for the personnel and also for the facilities. 

And I guess if you are having to contract with private labs, that 

may be great, but there are times that a public lab would be faster 

and ultimately cheaper to the folks who pay the bills. And so that 

is why I just ask FDA to look at that. I am glad we are going to 

contract because we want the commerce to flow. But if there is a 

need to have a lab that would be more economical and just as fast 

to contract with the private labs, then I would hope this funding 

source—I guess over the last three years, our hearings have said 

FDA is—the staff, we don’t have the staff, we don’t have the resources. Well, we are going to try to give you the resources in this 

bill and hopefully to hire the staff and to have the facilities. 

Dr. HAMBURG. And let me just assure you that your constituents 

are not being compromised in terms of the laboratory testing that 

is needed to protect their food supply because samples can be 

shipped to labs. In the modern era, it can be done in a timely and 

safe way. So the coverage in terms of laboratory testing is still 

available, but I hear and understand your concern about the gap 

in terms of an onsite facility in your region. 

Mr. GREEN. Well, and I think the fear that some of us had is that 

we don’t want to play favorites. These ports compete for cargo, and 


srobinson on DSK4SPTVN1PROD with HEARING
73 

we don’t want it to be based on that there is not an FDA lab or 

it is slower to get this through one port as compared to the other 

port. And I know I have run out of time but appreciate the responsibility you are taking on. And hopefully we will provide you with 

the tools that you need. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Green. Mr. Stupak. 

Mr. STUPAK. Thank you, Mr. Chairman, and thank you, Commissioner, for being here. As chair of Oversight and Investigations and 

one of the authors of the Food Safety Enhancement Act, I have 

done about nine hearings in the last two years just on food safety 

and certainly is a major problem. One of the problems I found 

every time we had a hearing, there is always lack of information 

that the FDA did not have from either the manufacturer of the food 

or the producer of that food. And it was always difficult to get information. 

The Safety Enhancement Act authorizes the FDA to issue subpoenas for records and other things relevant to any hearing investigation or proceeding or relative to any other matter within the 

FDA’s jurisdiction, including matters under the Public Health Service Act and the Federal Anti-Tampering Act. 

Do you believe subpoena power would be beneficial to the FDA? 

Dr. HAMBURG. It is very important for us to get access in a timely way to the information that we need, and I think that that authority will enable us to act more swiftly and effectively, yes. 

Mr. STUPAK. Well, I hope you would because I think we are still 

waiting for information from the 2007 salmonella outbreak and 

peanut butter and from the Georgia plant, Blakely, Georgia. I don’t 

think we got all that information yet. 

Some in the food industry though appear to be concerned that 

the FDA will abuse its subpoena power. Their concerns center 

around the subpoena provision that authorizes the FDA to issue 

subpoenas in matters under FDA’s jurisdiction that are not part of 

a particular hearing or investigation of a specific violation of the 

act. 

There seems to be a fear that FDA will go on fishing expeditions, 

constantly sending out burdensome unnecessary requests for documents. How would you address these concerns? 

Dr. HAMBURG. Well, I think that we have enough work to do 

without going on fishing expeditions. We would be seeking information that would be of vital importance to addressing the tasks at 

hand. It would be of great value to have the ability to access critical information, to inform the inspection process as well as to inform outbreak investigations. And I think that if we are going to 

be able to really move forward to ensure the safety of the food supply, this is one of a number of tools that will enable us to really 

do what needs to be done. 

Mr. STUPAK. That is refreshing to hear because I have been 

pushing subpoena power for the FDA for 10 years, and get a witness to agree from the FDA. But by the time I got back to my office, the FDA had called me and say that is not the official position 

of the FDA. We are against subpoenas. So it is refreshing to hear 

that, and I am sure you won’t use it for a fishing expedition. 

Let me ask you this. Chairman Waxman and I wrote to you to 

review this phenyl A BPA. While previous FDA commissioner 


srobinson on DSK4SPTVN1PROD with HEARING
74 

found no problem with it, FDA’s own science review found there 

was room for concern. And we wrote to you, and you wrote back 

indicating that you have agreed to review the safety of BPA. So let 

me just say thank you on that point. 

I think it is important that we look at all the documents and all 

the evidence and all the studies, not just two studies when there 

are over 100 other studies that raise concern on this phenyl A. 

Also on food safety, on the lab situation, it has been my concern 

the last FDA commissioner thought food safety was to close six or 

seven of the 13 field labs, which I thought was the wrong idea. So 

we have always fought reorganization or closing of these labs. And 

we actually had to put in legislation to make sure these field people, critical work for the FDA and for the safety of the American 

people, stay on their jobs. 

And you recently wrote back to me, myself and Chairman Waxman, indicating that there are no current or future plans to close 

or consolidate any of these 13 field laboratories. And you also went 

on and said that you are actually hoping you will be able to hire 

at least 70 new analysts for the 13 labs to replace staff losses over 

the last few fiscal years. So thank you for that, and without objection, I would like to place the record from the commissioner in the 

record, this letter in the record. 

Mr. PALLONE. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. STUPAK. Let me ask you one more question if I may. Riskbased inspection schedule. One of the important new requirements 

in the new food safety bill will be to put in place is a risk-based 

inspection schedule for food facilities. Under current law, even 

risky facilities can go years between FDA inspections, but our legislation has strict requirements to make sure FDA inspectors actually get into the riskiest facilities as frequently as possible. The 

riskiest facilities must be inspected at least every 6 to 18 months. 

No food production or storage facility will go more than four years 

between inspections. 

Under current law, there is not any requirement regarding how 

frequently these facilities must be inspected, is there? 

Dr. HAMBURG. There is not, and I think that your desire to see 

a risk-based strategy be put in place is absolutely key so that we 

can target resources on the highest risk. 

Mr. STUPAK. Does this bill give you the flexibility you need to 

modify the inspection goals based on available resources and the 

best available evidence on risk? 

Dr. HAMBURG. Well, as I said in my testimony, I am concerned 

about the requirements for inspection outstripping available resources, and that has been a chronic problem for the FDA in terms 

of being able to fulfill its important mission. 

I think that the inspectional strategy outlined in the draft legislation is a wonderful aspirational goal. I would love to be able to 

sit here and say that FDA could take it on and fully achieve it, but 

there is a reality of limited resources, both dollar and human. And 

I think that is where we need some flexibility to really look at the 

numbers and really also begin to move swiftly in the direction outlined in this bill but also try to learn as we go so that we can find 

ways to do our inspections in a more efficient targeted way and 


srobinson on DSK4SPTVN1PROD with HEARING
75 

really focus on the highest risk and really try to leverage other resources to achieve the goals as well through partnership with state 

and locals, partnership with foreign governments and potentially 

with third parties that are certified and overseen by the FDA to 

help us particularly with respect to the burgeoning number of foreign sites for inspection. 

Mr. STUPAK. Well, the—— 

Mr. PALLONE. I am sorry, Mr. Stupak, but we are—— 

Mr. STUPAK. I just want to mention about the registration fee 

for—— 

Mr. PALLONE. I am sorry. No more questions though. We are 

done with questions. Go ahead. You had a comment? 

Mr. STUPAK. Yes, I was just going to say hopefully the registration fee that we would be putting in place with up to 400,000 facilities would provide enough resources to do the inspection and other 

work that the FDA sorely needs to the resources and the personnel 

to do it. We understand that. Hopefully that will be part of the bill. 

And thank you, Mr. Chairman, and thanks for your help on this 

bill. 

Mr. PALLONE. Thank you. Mr. Deal. 

Mr. DEAL. Yield briefly to Mr. Shimkus for a follow up. 

Mr. SHIMKUS. And I thank my ranking member, and I am glad 

my colleagues here because I want to follow up on this 

wordsmithing that we talked about on the may cause. That is why 

we still have the same problem on the subpoena power issue because in the subsection three, it says ‘‘any other matter relative to 

the commissioner’s jurisdiction under this act.’’ I would like there 

to be a ‘‘may cause.’’ 

I have a problem with the ‘‘may cause’’ in the other part of the 

bill or the draft. We should at least have a ‘‘may cause’’ for offering 

a subpoena to someone. And so I would hope that that would be 

something else we would look at. So I think there is some issues. 

We want subpoena power, but we want it for a reason. We just 

don’t want it to be at the whim, with all due respect, Dr. Hamburg. 

And I will yield back to the ranking member. 

Mr. DEAL. Let me ask you a question with regard to another 

area, and that is the registration and fees collected from commercial importers, and there has been a change in this draft from previous drafts that we have seen. Specifically, why should drug and 

device manufacturers who currently already pay an annual establishment fee be required to pay a duplicative fee? And what entities 

are really encompassed within this commercial importation fee 

schedule? 

Dr. HAMBURG. Well, the importer fee refers to fees on the individuals or the companies that are serving as the link between foods 

that are grown, processed, manufactured overseas and being 

brought into the United States to be distributed to consumers here. 

And so they are not necessarily representing a given manufacturer, 

but it is a very important function because it is that bridge between what is happening on the international scene and what is 

coming into this country for use. 

Mr. DEAL. Specifically with regard to the drug and device manufacturers who currently already register and already pay a fee, 

would you envision that they are going to have to pay an additional 


srobinson on DSK4SPTVN1PROD with HEARING
76 

registration fee in addition to what FDA already collects from? And 

if so, why? 

Dr. HAMBURG. In terms of the importer function, I need to go 

back and look at this issue with respect to devices because I don’t 

know how that system is set up, whether it is the manufacturer 

that is serving in that role or not. So I will go back and learn more 

about that. 

Mr. DEAL. Would you take a look at that? I think that is one that 

we really seriously need to look at. I don’t think we ought to be duplicating what you are already doing because you have jurisdiction 

there. I think that would be unfair. 

Let me ask you also quickly with regard to the tracing of food, 

the tracing system that is put in place for you to issue regulations. 

It appears that that would include the restaurants to be able to 

have traceability, and I am told that 7 out of every 10 eating establishments are not part of chain operations. They are just independent, separate food operations. I am just curious as to whether 

or not you think that this would have a serious impact on these 

small business owners. And do you think we ought to do a cost/benefit analysis before we impose that kind of cost on these individuals? 

Dr. HAMBURG. Well, I think clearly we want to work with restaurant owners and small businesses in order to make sure that 

the systems are not too cumbersome, but it is very important that 

they keep records because if there is a tainted food that is in their 

facility, the implications for the health of their business as well as 

for the health of their consumers is very significant indeed. And I 

think that they would want to be able to assist in sharing their information about where the foods came from so that the traceback 

can occur and we can identify the source of an outbreak and control 

it. 

So I think they are a very important link in the food supply 

chain and, you know, protecting health really depends on them 

keeping records. 

Mr. DEAL. Let me ask you what has FDA done to implement the 

current, what I think is called the one-up-one-back traceability requirements? What has been done to implement that? 

Dr. HAMBURG. Well, the one-up-one-back has been in place, as I 

understand it, for a while now. But it has proven not to be adequate to really capture the full lifecycle of a product and that we 

really need, as we mentioned earlier, the full supply chain to be 

documented and integrated. Interoperability, not just fragments, 

you know, is really key to a successful and swift investigation of 

outbreaks and the ability to control a problem and prevent future 

exposures to a contaminated food product. 

Mr. PALLONE. Thank you. Just the way we are proceeding, Mr. 

Markey is going to go now, and he is our last—— 

Dr. HAMBURG. OK. 

Mr. PALLONE [continuing]. Questioner for you, Dr. Hamburg. We 

have one vote, but we will be right back after that. And then we 

will start with the second panel. So, Mr. Markey. 

Mr. MARKEY. Thank you, Mr. Chairman, very much. Congratulations, Dr. Hamburg. 

Dr. HAMBURG. Thank you. 


srobinson on DSK4SPTVN1PROD with HEARING
77 

Mr. MARKEY. You may know that I have a bill that calls for BPA 

to be banned from being used in food and beverage containers because of the risks that have been identified. We have also recently 

learned the food and chemical industries have launched a public relations campaign opposing any efforts to deal with this issue. 

Is the FDA concerned about BPA? And what does the FDA plan 

to do about those concerns? 

Dr. HAMBURG. Well, we are concerned. Certainly I am aware of, 

you know, some of the studies that have raised issues in animal 

populations and some of the information about BPA. In many components of the food supply, we are starting to see activities at the 

local and the state level in terms of action with respect to BPA. 

And I would hope that FDA could really be providing leadership on 

some of these issues of assessing and analyzing risk. 

We are taking another look at the BPA issue. The acting chief 

scientist at the FDA has been asked to take the lead on this because, of course, this is a decision where we have to bring the best 

available scientific data to bear. We need to look at all of the studies and examine them. But it is an issue of great consequence for 

Americans. As a mother as well as a physician, it is an issue that 

I think we need to look at seriously. 

And I look forward to being able to come back with some report 

from this serious look that is being taken. And we expect that it 

is going to be a task for him over the summer to lead this review, 

and by the end of the summer, beginning of fall, we hope to be able 

to put forward a fresh look at the BPA issue. 

Mr. MARKEY. Do you have any advice for parents who are concerned about their children ingesting this chemical? 

Dr. HAMBURG. Well, I think of course parents that are concerned 

can find alternatives that don’t have BPA, and I think that for the 

most part, I think that those alternatives are pretty clearly labeled 

and pretty available. And I think anyone with concerns, you know, 

should do so. 

Mr. MARKEY. OK, thank you for your work on this. If you could 

keep us posted on the progress you are making on—— 

Dr. HAMBURG. Absolutely. 

Mr. MARKEY [continuing]. The evaluation of it. Thank you so 

much. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, and thank you very much, Dr. Hamburg. As we have said, you know, we do intend to move forward 

on this bill next week, and we appreciate your input and whatever 

else comments you may give us by next Monday. We have one vote. 

We will come back, and then we will hear from our second panel. 

Thank you. 

Dr. HAMBURG. Thank you. Thank you for your leadership on this 

important issue. 

[Recess.] 

Mr. PALLONE. The subcommittee will reconvene, and I see our 

second panel is already seated. Let me introduce each of you. On 

my left is Mr. Michael Ambrosio, who is representing the Food 

Marketing Institute, and he is the vice president for Quality Assurance Division at Wakefern Food Corporation. Next we have Ms. 

Pamela G. Bailey, who is president and chief executive officer of 

the Grocery Manufacturers Association. And then we have Ms. 


srobinson on DSK4SPTVN1PROD with HEARING
78 

Caroline Smith DeWaal, who is the Safe Food Coalition food safety 

director of the Center for Science in the Public Interest. Dr. Tim 

F. Jones, who is a state epidemiologist from the Tennessee Department of Health. And last is Mr. Thomas E. Stenzel who is president and CEO of United Fresh Produce Association. 

Welcome. You know it is five minutes, and obviously your statements become part of the record if you want to include material 

more than the five minutes. And we all heard before—I know some 

of you are wondering if you can meet the deadline, but since we 

do intend to go to markup next week, I agreed with what Mr. 

Shimkus said about we will give you any additional written questions by the end of business tomorrow, and we would like them 

back by Monday at the end of business. 

So we will start with Mike Ambrosio. Thank you for being here 

again. 

STATEMENTS OF MICHAEL AMBROSIO, FOOD MARKETING INSTITUTE, VICE PRESIDENT, QUALITY ASSURANCE DIVISION, 

WAKEFERN FOOD CORPORATION; PAMELA G. BAILEY, 

PRESIDENT AND CHIEF EXECUTIVE OFFICER, GROCERY 

MANUFACTURERS ASSOCIATION; CAROLINE SMITH DEWAAL, 

SAFE FOOD COALITION, FOOD SAFETY DIRECTOR, CENTER 

FOR SCIENCE IN THE PUBLIC INTEREST; TIM F. JONES, 

STATE EPIDEMIOLOGIST, TENNESSEE DEPARTMENT OF 

HEALTH; AND THOMAS E. STENZEL, PRESIDENT AND CEO, 

UNITED FRESH PRODUCE ASSOCIATION 

STATEMENT OF MICHAEL AMBROSIO 

Mr. AMBROSIO. Thank you. Chairman Pallone, Ranking Member 

Deal, and members of the Health Subcommittee, I am honored to 

appear before you today on behalf of the Food Marketing Institute 

to present our views and suggestions on the Food Safety Enhancement Act Discussion Draft. 

FMI and its member company share the common goal of enacting 

legislation this year that would genuinely improve the safety of the 

food supply. Steps that actually prevent the presence of 

adulterance in the food supply are the only true way to improve the 

safety of our food. 

I am Mike Ambrosio, vice president of quality assurance, 

Wakefern Food Corporation. I have been in charge of food safety 

programs at Wakefern for 30 years. Founded in 1946, Wakefern 

has grown from a small struggling cooperative into the Nation’s 

largest retailer-owned, non-farm cooperative in the United States. 

We are headquartered in Keasbey, New Jersey. Wakefern, along 

with its Shop Rite Stores, employs over 47,000 individuals in New 

Jersey, New York, Pennsylvania, Delaware, Connecticut, Massachusetts, Rhode Island, and Maryland. 

Today I am also representing FMI, a national trade association 

that has 1,500 member companies made up of food retailers and 

wholesalers in the United States and around the world. 

FMI members operate approximately 26,000 retail food stores 

with combined annual sales of roughly $400 billion representing 

three-quarters of all retain food store sales in the United States. 


srobinson on DSK4SPTVN1PROD with HEARING
79 

FMI’s retail membership is composed of national and regional 

chains as well as independent grocery stores. 

This morning I will present several of FMI’s recommendations 

for revising the bill, but I ask that my entire statement be included 

in the record. 

In April of 2008, I testified before this subcommittee on legislation that would have modernized and overhauled the food safety 

systems at the Food and Drug Administration. Since that time, 

high-profile food safety outbreaks and recalls involving tomatoes, 

jalapenos, peanuts, and pistachios have not only made headlines 

but regrettably have caused illness and in some cases even death. 

Many of the themes and ideas that I share today will be similar 

to those that I shared in 2008, but there are differences that reflect 

lessons learned and new weaknesses in the existing food safety system identified from these latest recalls. 

As the purchasing agent for the consumer and the final link in 

the supply chain, our industry understands that it is vital to ensure that the FDA has the necessary authority, credibility, and resources to meet the challenges of today’s global marketplace. 

Consumer confidence remains an essential factor in this debate. 

Food safety issues can be extremely complex and consumer vary 

greatly in their knowledge of the science and other issues affecting 

the safety of our food supply. However as food safety issues draw 

national headlines, consumer awareness has a well concern about 

the safety of commercially prepared food and products purchased at 

the supermarket heightens. 

Mr. Chairman, I applaud you, Mr. Dingell, Chairman Waxman, 

and all members of the committee for your efforts to address 

changes that are needed to improve our food safety system. We 

support many of the proposals in the draft by emphasizing the 

need to have preventative measures be the foundation on which the 

food safety system should be built. The draft also recognizes that 

we need to focus on the majority of resources on facilities and products that pose the greatest risk of contamination that could result 

in food-borne illness or injury. We must continue to be sure that 

any changes meet certain criteria, be supported by science, have 

measurable benefits, be affordable, be realistic and be implemented 

without unintended consequences. 

First we applaud you for not only designating an entire section 

of the bill solely to prevention, but also putting this first in the 

most extensive section of the bill. From our perspective, this is the 

appropriate emphasis. 

In addition, I would like to specifically comment on certain sections of the draft. FMI recognizes that a strong public/private partnership is needed to help ensure safety of the food supply. Although every penny counts in this tough economic times, there is 

nothing more important than improving and ensuring the safety of 

our food supply. We are willing to support a fair registration or 

user fee provided that it is utilized by the FDA in a transparent 

and accountable manner to improve the safety of our food supply 

through means such as conducting research and consumer education programs. 

We look forward to working with the committee to address our 

concerns about how the FDA may utilize any fees collected. We 


srobinson on DSK4SPTVN1PROD with HEARING
80 

support the requirement that every registered food facility conduct 

a risk assessment and implement and maintain a validated food 

safety plan and identify potential resources of contamination and 

appropriate food safety controls and document those controls that 

would prevent, eliminate, and reduce potential hazards. 

Adherence to food safety plans goes a long way towards developing a culture within a company that is critical to ensuring food 

safety. Mr. Chairman, thank you for the opportunity to testify. We 

appreciate the work that has gone into the development of the Food 

Safety Enhancement Act discussion draft with the goal of improving food safety and the food supply and helping to restore consumer 

confidence in the food safety system. I look forward to your questions and remain available to the subcommittee. Thank you. 

[The prepared statement of Mr. Ambrosio follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
81 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 86 here 73752A.024
82 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 87 here 73752A.025
83 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 88 here 73752A.026
84 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 89 here 73752A.027
85 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 90 here 73752A.028
86 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 91 here 73752A.029
87 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 92 here 73752A.030
88 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 93 here 73752A.031
89 

Mr. PALLONE. Thank you. Ms. Bailey. 

STATEMENT OF PAMELA BAILEY 

Ms. BAILEY. Thank you, Mr. Chairman. Good afternoon. 

Mr. PALLONE. I don’t know if that is on, the mike. You don’t have 

a mike. 

Ms. BAILEY. Thank you. I am Pam Bailey, and I am president 

and CEO of the Grocery Manufacturers Association which represents more than 300 food, beverage, and consumer products companies. 

Americans enjoy one of the safest food supplies in the world, but 

we recognize that steps can and must be taken to make our food 

supplies even safer. We applaud Chairman Waxman, Chairman 

Emeritus Dingell, Chairman Stupak, and Chairman Pallone for developing the discussion draft of the Food Safety Enhancement Act 

of 2009. 

Product safety is the foundation of consumer trust. We look forward to working with the committee to quickly enact food safety 

reforms that will restore consumer confidence and will continually 

improve the safety of our food supply. 

Although the food industry is ultimately responsible for the safety of our products, strong government oversight is a critical part 

of our foods safety system. That is why GMA supports much in the 

discussion draft, including your proposal to set safety standards for 

fruit and vegetables, your proposals to improve the safety of imported food and food ingredients and your proposals to give FDA 

strong enforcement powers to deal with bad actors, including mandatory recall authority. 

In particular, we strongly support proposals to require all food 

manufacturers to conduct a hazard analysis to identify potential 

sources of contamination, identify appropriate preventive controls 

and to document those preventive controls in a food safety plan. 

We believe that food safety plans are the cornerstone of prevention and that they will help ensure that safety is built in from the 

very beginning. We have proposed certain modifications to some of 

these provisions to your staff, and we look forward to working with 

you. 

In particular, we look forward to working with you to address 

your concerns about traceability. We recognize that the discussion 

draft instructs FDA to assess the costs, benefits, and feasibility of 

traceability technologies and gives FDA the power to exempt certain foods. Furthermore, we recognize that the discussion draft instructs FDA to conduct pilot projects and public meetings. However, we believe these studies, meetings, and pilot projects should 

be completed before FDA decides whether and how to assign the 

food industry the responsibility for tracking a food product and 

which coding and identification systems may be best suited to this 

task. 

As you anticipate in the draft, the cost and feasibility of requiring every manufacturer to maintain the full pedigree of every ingredient in every food may outweigh the public health benefits. To 

address concerns raised during the peanut product recall, we urge 

you to consider whether intermediate distributors and brokers 


srobinson on DSK4SPTVN1PROD with HEARING
90 

should include on the labeling of their bulk ingredients the identity 

of the ingredient supplier. 

In general, we support proposals to give FDA stronger enforcement powers, including the power to order a recall. We believe that 

certain enforcement provisions of the discussion draft, such as 

mandatory recall and suspension of registration, should only be exercised by senior agency officials when there is a risk of serious adverse health consequences and should ensure that companies are 

afforded certain due process protections, such as an administrative 

hearing. 

As we saw during the recent recalls of tomatoes and jalapeno 

peppers, recalls can have a devastating financial impact, and they 

need to reflect the best science and wisest agency judgment. 

Finally, we strongly support efforts to provide FDA with additional resources. GMA helped create the alliance for a stronger 

FDA, and we have worked with other consumer and industry 

groups to increase FDA spending. If Congress enacts the FY 2010 

request of the FDA and the Obama administration, we will have 

seen food safety spending at FDA increase by nearly 80 percent 

since F& 2006. 

More funding is needed. We look forward to working with the 

committee to identifying appropriate role for industry. Our industry is significantly increasing our own investments in food safety, 

and we are prepared to make additional investments to continually 

improve the safety of our food supply and to comply with many of 

the new mandates that are envisioned in the discussion draft. We 

are not opposed to all fees, and I am confident that the committee 

can reach a bipartisan consensus on the agency’s resource needs 

and an appropriate role for industry. 

Let me close by saying again that the food and beverage industry 

is committed to working with you to quickly enact food safety legislation which makes the prevention of contamination the foundation 

of our food safety system. Thank you. 

[The prepared statement of Ms. Bailey follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
91 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 96 here 73752A.032
92 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 97 here 73752A.033
93 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 98 here 73752A.034
94 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 99 here 73752A.035
95 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 100 here 73752A.036
96 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 101 here 73752A.037
97 

Mr. PALLONE. Thank you. Ms. DeWaal. 

STATEMENT OF CAROLINE SMITH DeWAAL 

Ms. DEWAAL. Thank you very much. Thank you for your leadership, Chairman Pallone, and also the leadership from many other 

members of this subcommittee and committee. And also thank you 

to you, Ranking Member Deal, for the many hearings that we have 

sat through. We have listened to the witnesses. This work has been 

going on before this committee for a long time, and I think hopefully we are nearing an end. 

My name is Caroline Smith DeWaal, director of food safety for 

the Center for Science in the Public Interest, but today I am representing 10 consumer, public health, and victims’ advocacy organizations that are members of the Safe Food Coalition. 

Let me begin by saying that we believe this is a strong bill that 

will improve food safety. It requires food companies to build into 

their processes the conduct of regular hazard analysis, and they 

have the institute preventive controls to prevent problems from occurring. It provides a modern framework for food safety oversight 

to replace the antiquated food safety laws that have hamstrung the 

Food and Drug Administration. It gives FDA essential new authority to carry out the mission of preventing illnesses and outbreaks 

and to inspect food plants much more frequently, and it addresses 

the funding issues urgently needed to institute the program improvements, doing this with a modest registration fee. 

The heart of any effective reform effort lies in prevention, which 

is in the bill’s hazard analysis and preventive control section. The 

bill provides FDA with new tools like written plans and access to 

processing records that will allow government inspectors to review 

the conditions in plants over time, not just when inspectors are in 

the facility. 

We recommend additional strengthening of the bill by requiring 

companies or labs to report pathogen on final product samples to 

FDA whenever they are encountered in a facility. This would give 

FDA an early warning of problems and might prevent another 

tragedy, like the outbreak linked to the Peanut Corporation of 

America. 

It is a common adage that you cannot detect what you don’t inspect. Random and frequent inspection by public officials is a necessary component of an effective food safety system. This legislation divides food companies into three categories based on risk and 

directs FDA to inspect the facilities every six months to four years. 

While this is a vast improvement over FDA’s existing program, 

we continue to believe that more frequent inspections are needed, 

particularly of high risk facilities. Risk-based inspection is a concept that expands across the entire spectrum of food products not 

just those regulated by FDA. 

The registration fee, as proposed, is quite modest. And at $1,000 

per facility, it should provide somewhere between $300 and $400 

million in new revenue for food safety activities. Let us put this fee 

into context. In the Peter Pan outbreak, the average cost per victim 

reporting an illness was $2,650. And this is based on an estimate 

using the Economic Research Service Cost calculator. So when 

there is an outbreak, consumers who are affected may pay over 


srobinson on DSK4SPTVN1PROD with HEARING
98 

$2,500 or more. These are individuals. So clearly $1,000 fee on each 

facility to avoid these problems is more than reasonable, especially 

when compared to the cost of individuals and families that you 

have had here before this committee, testifying on the severe impact of food-borne illness. 

In addition, I would just like to note that companies themselves 

can run advertising campaigns to promote their products that run 

into the tens and even hundreds of millions of dollars. 

To conclude, I just want to say that polling has shown that the 

public has lost confidence in the safety of food. The percentage of 

consumers confident in food safety fell to about 22 percent according to the University of Minnesota’s Food Industry Center. This 

legislation provides a modern framework for FDA’s regulation of 

the food supply that will deliver many benefits to consumers 

though it does stop short of structural reforms that we also think 

are essential. 

We appreciate your leadership, and we believe that these new 

authorities that you are proposing will over time prevent the outbreaks and illnesses and help restore consumer confidence. 

Earlier this year, members of the Energy and Commerce Committee made commitments to the victims of the Peanut Corporation 

of America outbreak that change would come to FDA. President 

Obama said at a bare minimum, we should be able to count on our 

government, keeping our kids safe when they eat peanut butter. 

We urge you, Chairman, to act swiftly to finalize this legislation 

and to enact it. Thank you. 

[The prepared statement of Ms. DeWaal follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
99 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 105 here 73752A.038
100 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 106 here 73752A.039
101 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 107 here 73752A.040
102 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 108 here 73752A.041
103 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 109 here 73752A.042
104 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 110 here 73752A.043
105 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 111 here 73752A.044
106 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 112 here 73752A.045
107 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 113 here 73752A.046
108 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 114 here 73752A.047
109 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 115 here 73752A.048
110 

Mr. PALLONE. Thank you. Dr. Jones. 

STATEMENT OF TIM F. JONES 

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

you for the opportunity to be here today. Recent high profile outbreaks demonstrate the huge challenges and opportunities for improvement in the Nation’s food supply and food safety infrastructure. Laws, policies, and, to be frank, philosophies developed decades ago no longer suffice to successfully meet these new demands. 

The legislation we are discussing today is therefore a critical step 

in reviving the food safety capacities of the FDA. I work in a state 

health department as a epidemiologist responsible for investigating 

food-borne diseases and in effect cleaning up the mess left when 

things go awry in the food safety chain. 

I am excited to see that this proposed legislation addresses many 

of the problems that I experience firsthand in my role both investigating and helping prevent food-borne disease. 

Improving the traceability of food as called for in this legislation 

is fundamental to successfully achieving many of the other tasks 

described. If traceback information had been more promptly available and shared faster, I think that many of the problems associated with the recent tomato/jalapeno incident could have been mitigated. And likewise tracing peanut butter from one plant to 4,000 

different commercial products would have been utterly impossible 

with many other types of foods. 

Ensuring that all foods are traceable efficiently and accurately is 

critical to maintaining food safety. Contamination of produce and 

foods which are eaten uncooked are of particular concern because 

consumers have less control over the safety of those foods in their 

own kitchens. Setting standards for pre-harvest food production 

starts to close a major current gap in the Nation’s food safety system. 

Suspected produce-associated illnesses are particularly difficult 

to investigate from both the public health and regulatory perspectives. While large food service corporations and the suppliers often 

have excellent quality control programs with impeccable records, 

many other companies don’t. 

The portions of this bill requiring country of origin labeling, improved distribution records, and plans to regulate the safe production and harvesting of fruits and vegetables are important to help 

address these problems. 

I am pleased to see that the agency is being encouraged to markedly increase the scrutiny of food-handling entities. I would like to 

emphasize the importance of basing inspections and product testing 

and any other interventions by the agency on sound science. The 

bill does have important directives to improve testing in the science 

base of the agency’s activities. 

It is critical that from top to bottom activities are more efficient 

and effective and not just more frequent. This bill’s requirement 

that the agency’s activities are risk-based is particularly critical. It 

is likely that as technology improves, the value of traditionally defined inspections will change dramatically. And I urge that the 

agency retain sufficient flexibility and authority to adapt to 

changes rapidly and with as few barriers as possible. 


srobinson on DSK4SPTVN1PROD with HEARING
111 

I think it is important that in any discussion of the food safety 

system to emphasize the importance of interaction between FDA 

and CDC along with state and local partners and meeting the directive to enhance the science of food safety and develop risk-based 

approaches. Data from CDC and its partners on things like outbreaks, disease surveillance, and attribution of human disease to 

specific foods will be critical. It is imperative that such data are developed and shared cooperatively to meet the needs of all the partners involved in the system. 

In every discussion that I have been in pertaining to food safety, 

the importance and current inadequacy of effective information 

sharing is probably the most common single topic that is raised. I 

am pleased to see that issue addressed in this bill. Improving the 

technological capacity to share information will be important in accomplishing this, but perhaps even more important is changing the 

engrained policies of not sharing information among partner agencies far beyond any logical limit, even when the failure to do so 

threatens the public health. 

To meet the mandates of this bill, FDA will have to increase 

interaction and coordination with state and local agencies, which 

will require funding and focused attention. Federal regulatory 

agencies frequently are prohibited from sharing proprietary information obtained during investigations. The flow of information in 

both directions between FDA and CDC as well as state public 

health partners is critical. 

Examples of this include such things as distribution lists during 

recalls, information on suspected products or producers, and information on potentially exposed people. 

The FDA, CDC, and other partner agencies must have both the 

authority and expectation to share actionable information with the 

public health partners to the extent necessary to protect the 

public’s health. 

And I will conclude with a final comment about the importance 

of ensuring FDA and its state and local partners have adequate resources to meet the responsibilities with which they are charged in 

this bill. No one would argue that the FDA is currently underfunded, overworked and essentially overwhelmed. State and local 

food safety capacity must also be robust in order to maintain an 

effective food safety system. 

Adequate and consistent funding and resources must be dedicated explicitly to sustain the food safety programs at FDA as well 

as the state and local partners who work with them to keep the 

food supply safe. Americans will eat a billion meals today, and I 

can’t think of a better investment than one that will keep every one 

of those meals safe. 

[The prepared statement of Dr. Jones follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
112 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 118 here 73752A.049
113 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 119 here 73752A.050
114 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 120 here 73752A.051
115 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 121 here 73752A.052
116 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 122 here 73752A.053
117 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 123 here 73752A.054
118 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 124 here 73752A.055
119 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 125 here 73752A.056
120 

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

STATEMENT OF THOMAS E. STENZEL 

Mr. STENZEL. Good afternoon, Chairman Pallone, Ranking Member Deal, and members of the subcommittee. I am pleased to be 

with you. As you know, the fresh produce industry has been a leading proponent of strong federal government oversight of food safety. 

My name is Tom Stenzel. I am president and CEO of the United 

Fresh Produce Association. Our organization has been privileged to 

testify 10 times in the last two years before this committee or other 

members of Congress, perhaps only runner up to Caroline on this 

panel. 

Our board of directors in January of 2007 adopted a series of policy principles calling for mandatory, science-based regulation by 

the federal government. Today we congratulate you and the leadership of the full committee in presenting the draft of the Food Safety Enhancement Act of 2009 for consideration. 

While my written statement contains a number of suggestions for 

strengthening the bill, I will focus just now on three key areas of 

concern. Let me start by repeating those policy principles I mentioned. To protect public health and ensure consumer confidence, 

produce safety standards must allow for a commodity-specific approach based on the best available science, must be consistent and 

applicable to the identified commodity, no matter whether it was 

grown in the United States or imported, and it must be federally 

mandated with sufficient federal oversight of compliance in order 

to be credible to consumers. 

We are pleased that these principles are recognized in the draft 

Food Safety Enhancement Act. In looking specifically at the draft, 

we strongly support the bill’s intent in Section 104 for FDA to focus 

on maximizing public health by implementing regulatory standards 

for those specific raw agricultural commodities that it believes are 

most critical. The FDA has estimated that only five commodities 

have been associated with 80 percent of all produce-related foodborne disease outbreaks in the past 10 years, and that is where we 

must direct our resources. 

In a highly diverse industry that is more aptly described as hundreds of different commodity industries, one size does not fit all. 

We support Congress specifying that FDA have broad authority to 

regulate any produce commodities it determines necessary. But 

with a clear mandate to develop rule making that focuses resources 

for maximum public health benefit on those specific types of commodities for which the secretary determines that such standards 

are necessary to minimize the risk of serious adverse health consequences. 

We also recommend that Section 104 strengthen the support for 

collaboration between HHS and the U.S. Department of Agriculture and all state agencies in all areas of education, research, 

and enforcement with regard to produce. It is important that we 

bring the broadest knowledge and resource base possible to assist 

all stakeholders in understanding and complying with FDA set 

public health standards. 

Dealing with Section 107 on traceability, I want to assure the 

committee that fresh produce industry is committed to farm to fork 


srobinson on DSK4SPTVN1PROD with HEARING
121 

traceability of our products. As I presented in detailed testimony 

before the House Committee on Appropriations, Chairwoman 

Delaro’s Ag Subcommittee earlier this year, we have underway a 

produce traceability initiative to provide electronic traceability for 

6 billion cases of fresh produce that move annually within the 

United States. This is a massive and extremely expensive longterm undertaking, but it is a commitment that we have made. 

However we are concerned that the prescriptive nature of Section 

107 could actually derail these important efforts to bring the most 

cost efficient and cost effective technology to bear on this challenge. 

As you weigh various traceability provisions, we urge that Congress set the goal to mandate for food traceability but not overly 

prescriptive requirements such as those in this bill. 

Rather we believe Congress would be more effective in mandating an intensive evaluation of technologies, systems, and pilot 

tests that will truly lead to the end result we all desire. To that 

point, this legislation should set a goal for total supply chain 

traceability across the food industry, not single out individual food 

categories for traceability. 

Finally on the question of imports, I believe the committee 

should carefully examine all of the provisions regulating imported 

foods to assure equal treatment and fair standards for imported 

and domestically produced foods. This should be a principle maintained throughout all provisions. 

In Section 201, we support the bill’s intent to require importers 

to register with FDA and comply with good importer practices. The 

committee should make clear that this is the standard protocol for 

importing foods, and that the limitations and restrictions envisioned in Section 109 provide very extreme authorities to be used 

by FDA only in worst case scenarios when required to minimize the 

risk of severe adverse health consequences. 

With regard to imports, we also strongly support the concept of 

the safe and secure food importation program in Section 113 and 

urge that the bill require FDA to implement such a program with 

clear direction that it shall be implemented rather than may be implemented. 

Finally, let me mention 143 and country of origin labeling. The 

fresh produce industry is already required under the 2008 Farm 

Bill to provide mandatory country of origin labeling at retail point 

of sale. Our industry has moved rapidly to ensure compliance with 

this law and urges that those products which are already covered 

be specifically exempted from any new duplicative coverage under 

the FDNC Act. 

Let me conclude with a comment about public health. The very 

Department of Health and Human Services that regulates our safety has the dual responsibility to promote public health but consider 

the fact that we need, as Americans, to double our consumption of 

fruits and vegetables to meet the very simply U.S. dietary guidelines. 

With that public health imperative, fears of food safety have no 

place in the fresh produce department. Thank you for your leadership on this effort. 

[The prepared statement of Mr. Stenzel follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
122 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 128 here 73752A.057
123 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 129 here 73752A.058
124 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 130 here 73752A.059
125 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 131 here 73752A.060
126 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 132 here 73752A.061
127 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 133 here 73752A.062
128 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 134 here 73752A.063
129 

Mr. PALLONE. Thank you, and thank all of you. We will now take 

questions from the panel, five minutes each, and I will start. 

I wanted to start with Ms. DeWaal. Many in the industry have 

called for prevention, or I should say a stronger emphasis on prevention. And many feel that we need to share the responsibility for 

making food safe. The FDA obviously does an important job, but 

manufacturers must also be responsible for the foods that they 

make. 

Now, one of the ways that the draft before us proposes to do this 

is through a new emphasis on prevention. It requires companies to 

conduct hazard analysis to identify potential safety risks for the 

food they handle. It then requires that the facility owner adopt preventive measures to reduce or eliminate these risks. 

So, Ms. DeWaal, can you elaborate on how preventive controls, 

such as those put forth by the bill, will help make food safer? And 

could you give us some examples of preventive controls and how 

they might be implemented or applied? 

Ms. DEWAAL. Thank you, Chairman Pallone. The systems that 

are going to be applied in this bill are well tested. We have 

watched the implementation of what are called HACCP or hazard 

analysis critical control point systems in the seafood industry, in 

the beef and poultry industries, and in the—also in fresh juice and 

several other industries. 

The problem would be the approach that FDA has been taking 

up until now and the solution that your bill will bring to the agency is that they have been trying to apply these systems one by one, 

industry by industry. And I think what you see here is a unitary 

view, among industry and consumer organizations, that these systems are needed across the board. They are developed by the industry. They are driven by the industry. They design the programs, 

but the government can use them to actually go in and conduct inspections, which are much more meaningful than the ones they do 

today. 

Mr. PALLONE. Well, let me ask each of you. I will ask Ms. Bailey 

and then go to the others quickly if you would respond, whether 

you support these preventive approaches to food safety. 

Ms. BAILEY. Absolutely. Yes, sir. 

Mr. PALLONE. OK, Mike? 

Mr. AMBROSIO. Yes. 

Mr. PALLONE. Dr. Jones? 

Dr. JONES. Yes, sir, we do. 

Mr. PALLONE. All right, great. I mean obviously a consensus on 

the preventive approach being the critical part of the bill. I wanted 

to ask about access to records though too. One of the new requirements in the bill references access to records. Section 106 requires 

that food manufacturers and producers retain records relating to 

the foods they produce, and upon request, provide these records to 

the FDA. FDA would, in the event of a food-borne disease outbreak 

or during an inspection, have access to information on how foods 

were produced, manufactured, transported or stored. And I will initially ask Dr. Jones. Can you describe for us how this type of 

records access would be helpful to the FDA in the event of a foodborne disease outbreak? 


srobinson on DSK4SPTVN1PROD with HEARING
130 

Dr. JONES. Well, I mean I think access to those records are critical in order for them to sort of pinpoint their interventions, but I 

also think the ability for FDA to share that data with other agencies that assist them in those investigations is critical. And that 

has been a huge barrier for us. I mean I worked on outbreaks 

where FDA had the names and phone numbers of people that had 

consumed contaminated product and would not or thought that 

they could not share that information with public health departments that are responsible for calling those people and telling them 

not to eat the stuff. And that is just mind-boggling to me. I mean 

I think it is subtle, but there is some addressing that issue in this 

bill. 

Mr. PALLONE. You want to comment also, Ms. DeWaal on whether you believe that this access to records provision will help protect 

public health? 

Ms. DEWAAL. The access to records provision gives the agency 

the ability to look at plants. When they visit them, they can look 

at them as they are operating over time. Today when an FDA inspector goes into a plant, they just see the four walls of the plant. 

They may not even get access to any records in that facility. They 

can look at production practices as they are happening on that day. 

But with the access to records provision together with this preventive control system and this written food safety plan, the inspector will be able to go and look back and where the company 

has faced perhaps challenges in its operation and how they have 

addressed them. 

Mr. PALLONE. OK, thank you. I mean I don’t know if anybody 

else wanted to address that, but I think that is fine. Thank you. 

Mr. Deal. 

Mr. DEAL. Thank you. Mr. Stenzel, I guess I am going to start 

with you from the producer side of it. First of all, in a general context, do you see any problem or potential of this legislation creating 

overlaps with FDA jurisdiction and requirements to do things 

versus current USDA requirements to do things in our food supply? 

Mr. STENZEL. We don’t see any jurisdictional issues in public 

health in that sense. FDA has the statutory authority now to regulate the fresh produce industry. We do suggest strongly that there 

be a good coordination with the U.S. Department of Agriculture in 

education, enforcement. Certainly one of the keys to implementing 

this bill is going to be an effective structure with FDA working 

with USDA and state and local agencies in compliance, enforcement, inspections. That needs to be strengthened, but there is not 

a jurisdictional issue of competing authorities. 

Mr. DEAL. My understanding is that at the production level that 

good agricultural practices are the primary preventive tool and 

mechanism for dealing with it at the production level. Do you see 

perhaps that an updating or improvement on those agricultural 

practices standards as they apply to fruits and vegetables is important? And is there anything here that would prevent that from taking place? 

Mr. STENZEL. Yes, sir, Mr. Deal, that is an extremely important 

part. The FDA’s good agricultural practices are called to be updated in this draft legislation. We strongly support that as the 

baseline guidance for all fruit and vegetables. For those specific 


srobinson on DSK4SPTVN1PROD with HEARING
131 

commodities in which FDA has determined a significant level of 

risk, then you move into the rule making procedure. But that is 

one of the key things. It is the way we can best focus our public 

health resources on the greatest risk. 

I said in my testimony that 80 percent of all the outbreaks have 

been associated with just five commodities. So the basic good agricultural practices are very appropriate for all fruits and vegetables, 

but let us focus the rule making on those specific commodities that 

require it. 

Mr. DEAL. And, Ms. Bailey, I believe you made the point that 

since we have mandated studies and pilot projects, et cetera, that 

those be completed before we start trying to write the rules and 

regulations. Is that one of the points you were making? 

Ms. BAILEY. On traceability, yes. 

Mr. DEAL. Yes. It seems to me that if we are going to do the 

studies and the pilot projects, we ought to do that before we write 

the regulations because presumably they will give us the information to guide us in the rule making process. So I think your point 

is well made. In that regard, Mr. Stenzel, your industry has already put in place some traceability standards. How do you see 

your current efforts in traceability? How do they correspond with 

what is in this legislation? 

Mr. STENZEL. I tell you this is proving to be a massive, massive 

undertaking, and, you know, we are committed to doing it even on 

a voluntary basis before any type of requirement. But extremely 

complex system of creating that interoperable system that can see 

the life cycle all the way through of our products. But some of the 

specific language in this bill, the full pedigree of each product, 

gives us great cause for concern. 

Even though we are moving down a path of hundreds of millions 

of dollars being invested in interoperable traceability systems, we 

don’t think they might meet exactly the terms of this bill. So we 

would also strongly advise that FDA be mandated to get involved 

in the technology, in the pilot test, learn about each industry, and 

then write the regulation. 

It is premature to tell every industry exactly how it should be 

done until we have this greater learning. 

Mr. DEAL. One of the scares that we have alluded to here was 

the Mexican pepper scare that adversely impacted the tomato industry. And I guess I would ask you again how do we ensure that 

foreign producers meet the kind of standards that we would need? 

Would it require, in your opinion, some kind of foreign producer 

verification system of some sort? 

Mr. STENZEL. Well, I think the requirements in the import section are appropriate. That importers will now be required to register with the FDA, and as part of good importer practices, they 

will have to assure that their products have been grown in accordance with these standards. We believe that is an appropriate step 

to be taken. 

I don’t think anyone envisions going, searching around on every 

farm around the world, nor every farm in America to be honest 

with that. That is simply not going to be the case. The authority 

should be there for FDA if they need to investigate an issue, but 


srobinson on DSK4SPTVN1PROD with HEARING
132 

the basic responsibility is going to lie with the importer or the food 

manufacturer. 

Mr. DEAL. Does your organization represent the organics producers? 

Mr. STENZEL. Yes, sir, we have a number of organic suppliers in 

our group. 

Mr. DEAL. Thank you. I have a statement, and I think we have 

cleared it with your staff from the Frozen Food Institute to be inserted in the record? 

Mr. PALLONE. Without objection, so ordered. Chairman Dingell. 

[The information appears at the conclusion of the hearing.] 

Mr. DINGELL. Mr. Chairman, thank you. I would like to commend the panel for their very helpful testimony and thank you all. 

I would particularly like to address my questions, however, to Ms. 

Bailey from GMA. I would like to first begin by welcoming you. I 

would like to follow up by thanking you for the cooperative way in 

which you and GMA have been working with the staff to try and 

resolve the difficulties which we confront. And I would like to also 

express my particular thanks to you for the most helpful way in 

which you have behaved and the remarkable change that has occurred under your leadership. So I thank you. 

First of all, am I fair in stating that FDA has been so underfunded that they have not been able to provide the necessary services to protect either the industry or the consumers for a number 

of years? 

Ms. BAILEY. That is right. 

Mr. DINGELL. And as a result, they have been unable to adequately fulfill their role in ensuring the safety of the Nation’s food 

supply? 

Ms. BAILEY. Yes, we would agree. 

Mr. DINGELL. Unfortunately our reporter doesn’t have a nod. You 

have to say yes or no. 

Ms. BAILEY. I am sorry. I said yes, and if I could give an example, FDA has not been able to update good manufacturing practices 

since 1986, and that is just one example of something they have 

not been able to do without adequate resources. 

Mr. DINGELL. That sounds like a very serious matter. Tell us 

what that means. 

Ms. BAILEY. Well, good manufacturing practices serve the 

basis—— 

Mr. DINGELL. Those are required both in food and drugs, cosmetics and also—— 

Ms. BAILEY. That is right. 

Mr. DINGELL [continuing]. In pharmaceuticals. 

Ms. BAILEY. That is right, and so the preventive controls that we 

are talking about, in HACCP for example, are one step up from 

good manufacturing practices. You want to have them updated, 

and as we all know, there have been enormous advances in manufacturing and food processing since 1986 relating to pathogen control, environmental testing, all of the advancements. And FDA has 

not been able to incorporate them into updated good manufacturing 

practices guidance for industry. 

Mr. DINGELL. Would you also agree that FDA’s science base has 

eroded? 


srobinson on DSK4SPTVN1PROD with HEARING
133 

Ms. BAILEY. Absolutely yes. 

Mr. DINGELL. And that the FDA’s information technology systems are inadequate? 

Ms. BAILEY. Yes. 

Mr. DINGELL. And that FDA has not been doing an acceptable 

level of surveillance and research? 

Ms. BAILEY. That is right. 

Mr. DINGELL. Would you agree that they have not conducted a 

satisfactory number of inspections over the years? This figure I got, 

which seems interesting. FDA conducted 6,562 domestic food facility inspections in 2008, 152 foreign food facility inspections in 2008. 

The total number of registered facilities is 378,000, but there are 

many more out there in the world who are shipping stuff to us. Is 

that a fair statement? 

Ms. BAILEY. That is an accurate statement, yes. 

Mr. DINGELL. Thank you. And I am sure that you agree, as you 

have said in your statement, that FDA needs additional resources 

to do their job? 

Ms. BAILEY. Yes. 

Mr. DINGELL. And I want to commend you very much for the way 

that you have been working with us on the registration and the fee 

question. And I want you to know that we are going to try very 

hard to see to it that we come up with something that enables industry to work, prosper, have a satisfactory Food and Drug Administration, one which protects the consumers but also which doesn’t 

overburden the industry. And we look forward to continuing our efforts on that, and I hope that you will continue to give us those 

assistances. 

And again the reporter has no nod but—— 

Ms. BAILEY. Yes, we look forward to that. I thought that Dr. 

Hamburg this morning laid a good basis for those discussions going 

forward. 

Mr. DINGELL. I am troubled about foreign people who deliver food 

into the United States. Food and Drug doesn’t have the right number of inspections and inspectors at the border, do they? 

Ms. BAILEY. No, that is right. They do not. 

Mr. DINGELL. I am told they only inspect about one percent of 

foods coming into the United States. And the games are played oftentimes where they are turned back, rather where food shipments 

are turned with the result that they go out and come in another 

port. Are you troubled about that? 

Ms. BAILEY. Yes, we need strong inspections at the border. 

Mr. DINGELL. Now, I am also troubled about the fact that Food 

and Drug has no understandings with their sister agencies, with 

customs, with immigration. So as a result a lot of times, their inspectors will be at the ports, and there is no Food and Drug folk. 

We ought to see to it that there is a cooperative agreement there 

to make that possible so that they would work together instead of 

ignoring each other’s business. Isn’t that right? 

Ms. BAILEY. I think that sounds like a good idea, yes. 

Mr. DINGELL. Now, I note that I am three seconds overtime. 

Pleasure to have you before us. Thank you. Thank you, Mr. Chairman. 

Ms. BAILEY. Thank you, Mr. Dingell. 


srobinson on DSK4SPTVN1PROD with HEARING
134 

Mr. PALLONE. Thank you, Chairman Dingell. Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. I have a lot of questions. I am going to try to be quick. You all sat in the first testimony. Can any of you tell me what ‘‘may cause’’ means? Mr. 

Ambrosio, do you know what ‘‘may cause’’ means? 

Mr. AMBROSIO. It is a very vague term. 

Mr. SHIMKUS. OK, Ms. Bailey, ‘‘may cause’’? 

Ms. BAILEY. I am not certain, no. 

Mr. SHIMKUS. OK, Ms. DeWaal? 

Ms. DEWAAL. Thank you. The actual subsection says ‘‘if the secretary has reason to believe that the use or consumption of or exposure to an article of food may cause adverse health consequences.’’ 

So the actual standard, sir, is ‘‘reason to believe’’ and the ‘‘may 

cause’’ is in there, but it really is a standard which is very protective of public health. Thank you. 

Mr. SHIMKUS. Dr. Jones? 

Dr. JONES. I agree with those comments. 

Mr. SHIMKUS. And Mr. Stenzel? 

Mr. STENZEL. I believe that it is a much more vague standard 

than that. 

Mr. SHIMKUS. And I hope we can work to clean up that language, 

and I think there is an opportunity to do that. Let me ask this subpoena question again to those who may want to talk about that. 

There are three criteria in Section 311 which I didn’t allude to the 

first. First, ‘‘does any hearing, investigation, and other proceeding, 

respecting a violation of the act’’? I think most people agree subpoena. 

‘‘Any hearing, investigation or other proceeding to determine if a 

person is in violation of a specific provision of this act’’? I think an 

average person would say oK, subpoena these babies. 

The third one, ‘‘any other matter relative to the commissioner’s 

jurisdiction under this act, the Public Health Service Act, and the 

Federal Anti-Tampering Act.’’ Any other matter, vague or not? Mr. 

Ambrosio? 

Mr. AMBROSIO. It is vague. 

Mr. SHIMKUS. Thank you. Ms. Bailey? 

Ms. BAILEY. Yes, that—it is vague. 

Mr. SHIMKUS. Ms. DeWaal? 

Ms. DEWAAL. Actually these acts are important to protect us 

against swine flu, against bioterrorism. So in fact, these acts, if you 

understand the relationship between the Food, Drug, and Cosmetic 

Act, and these other legal statutes, I think the language may be 

appropriate but—— 

Mr. SHIMKUS. It may be. It may not be. It may be. 

Ms. DEWAAL [continuing]. We will go back and look at it. 

Mr. SHIMKUS. OK, thanks. Dr. Jones? 

Dr. JONES. I am a physician, not a lawyer. 

Mr. SHIMKUS. OK, neither am I, but I pretend to be one here. 

Dr. JONES. You know, so my tendency is to err on the side of protecting the public’s health, but I agree it is somewhat vague. 

Mr. SHIMKUS. My tendency is to question the legal language of 

the law that may harm folks by the—I found the language of the 

law is very important. And interesting things can be done as this 

gets crafted. Mr. Stenzel, I think it is also quit a general standard 


srobinson on DSK4SPTVN1PROD with HEARING
135 

and do suggest it is an area to look at throughout the bill. Thank 

you. 

Mr. Stenzel, I want to ask specifically on Section 104, which calls 

for the secretary to issue regulation on produce safety standards. 

The language in the bill says the standard may include minimum 

standards for safety. This is a lot of the language stuff that I have 

been focusing on today. Why would we want the agency to issue 

minimum standards instead of the appropriate standards for safety? 

Mr. STENZEL. Mr. Shimkus, thank you for raising that. That is 

actually a subject I addressed in my written testimony. I don’t 

think we should be using such terms as minimum or expecting 

minimum standards. We should have the agency write the standards that are most appropriate that all producers should follow. I 

can tell you this: that as soon as we have minimum standards, the 

first thing that is going to happen is someone is going to say that 

is not good enough. 

So if we are going to go down this path, let us make sure the 

agency writes the most appropriate standards. 

Mr. SHIMKUS. And that is that whole debate that we always have 

appear about some certainty. Industry needs certainty. If we have 

vague language, there is uncertainty, and with uncertainty comes 

higher risk because of trying to comply. I appreciate that. Ms. Bailey, what was surprising in the draft is—and I was on the ONI last 

Congress. I can’t talk about what was the hearings in previous 

Congresses or what is going on this time. 

But baby formula has popped into this debate, and I know of no 

hearings on baby formula in the last Congress when I was ranking 

on ONI. Have there been any reported problems that would suggest that there needs to be a reason to change the way infant formula is regulated? In the premises, it is highly regulated already. 

Do you want to comment on that? 

Ms. BAILEY. Yes, we are not familiar either with the origin of 

that provision. We noticed it in this draft, and we are, of course, 

aware of how high the regulated baby formula is. And we are interested in receiving further information, but it obviously is very important, as is the safety of the product and the availability to mothers and children. 

Mr. SHIMKUS. And thank you, Chairman. My time expired. I 

would have gone on with a pilot program. I think that has been 

discussed a little bit. I know Mr. Ambrosio has some comments, 

and I think a pilot program might be important. And I yield back. 

Mr. PALLONE. The problem that we have is there is an important 

vote on our other subcommittee. So I would like to adjourn for just 

five minutes so that the members can go and vote in the other subcommittee, and we will come right back. So the subcommittee, if 

you bear with us, is just in recess for five minutes. 

[Recess.] 

Mr. PALLONE. Ms. DeGette. 

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

echo Mr. Dingell’s thanks to every single witness here for working 

with us on this legislation. All of your input has been very, very 

important, and none of you will be surprised to know I want to talk 


srobinson on DSK4SPTVN1PROD with HEARING
136 

about the mandatory recall provisions of the bill, and I want to 

start with Ms. DeWaal. 

First of all, do you think, Ms. DeWaal, that the current provisions of the Bioterrorism Act are sufficient to give us the mandatory recall that we need in a robust food safety system? 

Ms. DEWAAL. No, I don’t. 

Ms. DEGETTE. And why is that? 

Ms. DEWAAL. Well, the Bioterrorism Act actually didn’t really 

give them mandatory recall, but it does give them the authority to 

take certain actions like administrative detention and some other 

actions when they meet a very high—— 

Ms. DEGETTE. But to interrupt you, it really has the one step 

back and one step up. Is that sufficient to give us the whole 

traceability? 

Ms. DEWAAL. I am sorry. 

Ms. DEGETTE. I said mandatory recall, and I meant traceability. 

Ms. DEWAAL. OK, I am sorry. Traceability—— 

Ms. DEGETTE. That is what happens when you break my train 

of thought. 

Ms. DEWAAL. Thank you for that clarification. The one step up 

and one step back traceability was a good first step into this area, 

but I think the provisions in this bill are much improved on that. 

What we have seen over the years, since that law was passed, is 

that the FDA itself has had trouble with identifying food products 

involved in major recalls and outbreaks. 

Ms. DEGETTE. Because it just doesn’t go far enough forward or 

backward, correct? 

Ms. DEWAAL. Right. 

Ms. DEGETTE. And, Dr. Jones, you are nodding your head yes as 

well. 

Dr. JONES. Yes, I mean I think there is such a huge food production chain that if there is one point in the chain where records 

aren’t good—— 

Ms. DEGETTE. You lose the whole thing. 

Dr. JONES. I mean if Bruno’s produce doesn’t know where it came 

from, you could have the rest of the industry known, and you can’t 

get anywhere. 

Ms. DEGETTE. Right, thank you. Now, I want to ask you, Mr. 

Amobrosio, Ms. Bailey, and Mr. Stenzel, I have read all of your testimony and listened to you here today. You don’t object in general 

to the concept of traceability, do you, Mr. Ambrosio? 

Mr. AMBROSIO. No. 

Ms. DEGETTE. Ms. Bailey? 

Ms. BAILEY. No. 

Ms. DEGETTE. And Mr. Stenzel? 

Mr. STENZEL. No, ma’am. 

Ms. DEGETTE. And in fact, Mr. Ambrosio, in your testimony, you 

recommended that the secretary be allowed to design systems 

based on information gathered and not be mandated to develop a 

specific type of system prior to those efforts, correct? And, Ms. Bailey, in your testimony, your written testimony, you talked about 

the concept of including intermediate distributors and brokers in 

the labeling of bulk ingredients to the supplier so that we could get 

that traceability, correct? 


srobinson on DSK4SPTVN1PROD with HEARING
137 

Ms. BAILEY. That is right, yes. 

Ms. DEGETTE. And, Mr. Stenzel, I have to say the produce industry in this country was really—maybe I shouldn’t say this in front 

of everybody else, but you folks were the ones that gave me courage 

to believe that we could do traceability because you are doing such 

a great job. So I want to commend you. I guess the issue, as I 

heard in all of your testimony today, is some concerns with the specific language of Section 7 of the committee draft. Would that be 

accurate to say, Ms. Bailey? 

Ms. BAILEY. That is right. 

Ms. DEGETTE. And I just want to—you know you talk in your 

verbal testimony today about the tomato recall, and you were talking about mandatory versus voluntary recalls. But that made me 

think about traceability too because it doesn’t really matter if the 

recall is mandatory or voluntary. If it is overbroad, it is still—I 

guess I should ask you, Mr. Stenzel, since it is produce. If it is 

overbroad, it still devastates the entire market, correct? 

Mr. STENZEL. Yes, that is absolutely correct. 

Ms. DEGETTE. So really what you want to have is the ability to 

quickly trace where contamination came from foods, correct? And, 

you know, what we have been seeing lately, I was thinking about 

the latest, the pistachios, where they were saying just don’t eat any 

pistachios. Then I thought well, what if you had pistachios that 

were incorporated in granola or something like that that went a 

long way. You could really devastate a food agency. Ms. Bailey, I 

wonder if you want to comment on that. 

Ms. BAILEY. I think first of all we are absolutely sympathetic 

with your goal and the importance of improving our traceability 

systems. I think it is a matter of prioritizing how we go about it. 

That is why we recommended—first of all, there is a difference between a single product like a strawberry that is ready to eat versus 

ingredients that may be co-mingled and—— 

Ms. DEGETTE. Right. 

Ms. BAILEY [continuing]. And put into additional products. 

Ms. DEGETTE. Exactly, right. 

Ms. BAILEY. And we saw in the peanut paste problem that when 

there are brokers involved, PCA would sell the paste to a broker 

who would then sell it to an end manufacturer. And that is why 

we included the recommendation that the distributor label it. 

Now, going forward, what we have learned working with our 

member companies and other areas of the food industry, it can be 

enormously expensive when you start to deal with co-mingled ingredient commodity products, and that is where we caution. And 

we think the legislation has it absolutely right. Let us ask FDA to 

first identify cost/benefit because in the end resources are finite. 

Ms. DEGETTE. Right, let me just say, because my time has expired, that I really hope all of you will come in and work with us 

on this particular traceability language because from the very early 

days of my working on this issue, what you are saying is exactly 

my view, which is we need to have traceability throughout the industry but that we can’t have a one-size-fits-all traceability system 

or technology. The key is those things be interoperable. 

So if you have tomatoes and peppers mixed in a salsa, that is one 

level of complexity. If you have that salsa incorporated in a procVerDate Mar 15 2010 20:13 Jun 15, 2012 Jkt 073752 PO 00000 Frm 00143 Fmt 6633 Sfmt 6633 E:\HR\OC\A752.XXX A752

srobinson on DSK4SPTVN1PROD with HEARING
138 

essed food, that is another layer of complexity. And then if you 

have that put into something at a restaurant or any place, that is 

another layer. So we have to really work on that. 

What I am amazed about though is that we do have the technology, and we just need to work on it. So I hope you will all work 

with us in the next week to improve this language. Thank you for 

your indulgence, Mr. Chairman. 

Mr. PALLONE. Mr. Buyer. 

Mr. BUYER. I had to take a deep breath because Mr. Matheson 

and I and I guess now Chairman Dingell and Gene Green, you 

know, we have taken this trying to educate the committee here on 

electronic pedigree with regard to drugs. Yet now all of a sudden, 

there is this great interest to do something expansive on pedigree 

with food. 

So I just want you to stop and ponder and think about this, Mr. 

Chairman, because as we move to the Drug Safety Bill, it is the 

reason I went right at the FDA Commissioner. You can’t say I have 

this level of interest in making sure that they go after tainted food 

but with regard to drugs well, maybe that is a little bit different. 

We are not going to send this message to the country that tainted 

food, bad lettuce, that is really awful, but we can have a different 

standard when it comes to bad Lipitor. I am uncomfortable. 

Let me ask some questions because I don’t think I completely understand. When I look at Section 106 and Section 107, we have sort 

of an all-in, and then under traceability, we have some exemptions. 

So you know I come from a very small town. I grew up on the Tippecanoe River, Buffalo, Indiana. We have two stops signs on either 

side of a bridge. That is the size of the town I come from. So I 

think about small businesses, and I worry. 

So when we think about access to records, and we are going to 

say requirement with regard to restaurants. Are we going to include concessionaires? Does anybody anticipate that, that we would 

include concessionaires? So that when you go to MCI Arena, how 

about when you go to the college football game? How about high 

school? How about little league? You know we make deer chili at 

our little league games. I mean what all is going to be included? 

How about convenience stores? How about when you pull into 

that mom-and-pop gas station and they have created something? 

You can get elk sausage. I mean what kind of requirements are we 

going to be placing, and where do we stop? Has anybody thought 

about do we as a committee need to have better definition as to 

who is in and who is out? Total silence. Yes? 

Mr. STENZEL. Congressman, at the risk of your wrath, I just 

don’t think that food safety is something that is determined by 

scale or size of company. I run a trade association that has many 

very small members who are going to be extremely challenged to 

comply with this regulation. We also have very many big members, 

but in last summer’s outbreak, we also found that some of the 

issues and some of the issues where people were getting sick were 

the very smallest restaurants. And we have to be able to have a 

system that takes care of—— 

Mr. BUYER. Well, there is food handling. There is a different between food processing and food handling, right? 

Mr. STENZEL. Yes, sir. 


srobinson on DSK4SPTVN1PROD with HEARING
139 

Mr. BUYER. So the people up here on this dais love to talk about 

all these food-borne pathogens and all these sicknesses that everybody comes down to predominantly deals with the handling of food, 

right, not so much always the processing of food at a manufactured 

facility? I almost feel like they are being used as a scapegoat when, 

in fact, it is other handling. And probably everybody here in the 

audience and around the country, we have all gotten sick because 

somebody left the mayonnaise out overnight or something. 

Well, when I look at the traceability requirement, we decide, I 

guess, farms, for example, they got to keep their records or, I 

guess, little league has to keep their records or everybody that is 

going to be involved with food is going to have to keep their 

records, but we are going to exempt now restaurants and farms 

would be required to maintain the safety records. But direct sales 

by farms are exempt. 

What about seafood? So if we are going to exempt on the farm, 

are we going to exempt seafood? How about that trawler that goes 

right out there, gets the seafood and he owns the restaurant and 

the trawler and processes the food? Should they be exempted just 

like we are going to exempt on the farm? Total silence. See those 

are the same kind of questions I have. When we start picking and 

choosing where we draw the line. Ms. Bailey? 

Ms. BAILEY. If I could, the language in that section at the end 

is very important and I think goes to the heart of our concerns. 

There are a number of questions. There has to be a sense of what 

is feasible technologically, what the cost/benefit is, and what the relation is to food safety. 

Mr. BUYER. If we are going to exempt farms, should we exempt 

trout farms, catfish farms? How about fish caught on the Great 

Lakes? What about seafood? 

Ms. BAILEY. I think those are all questions that need to be answered, and if I could offer, the analogy might be—this is very 

similar to electronic medical records in that it is a concept that 

makes good sense. But it is not easy to achieve and there are many 

reasons why it is not easy to achieve both technologically and—— 

Mr. BUYER. Well, see it is easier for me to be able to achieve electronic pedigree in the drug industry when I have specific companies, yet I can’t get cooperation here to do this. But they say that 

what I am trying to do is too complex? What the heck is this? This 

is a decentralized model of the umpteenth degree. I would love to 

work with you, Mr. Chairman. I yield back. 

Mr. PALLONE. Thank you. OK, we are done with our questioning, 

and just a reminder again. You heard us earlier about that you 

may get written questions by the close of business tomorrow, and 

we would like you to answer them by the close of business on Monday. And again I want to thank you all. This was very helpful. I 

can’t emphasis enough that even though, you know, our plan is to 

go to markup next week, that we would very much like and we intend to, you know, consider a lot of the statements that were made 

today as we move forward over the next week. And several members have commented on how valuable, you know, your testimony 

is going to be as we move forward. 

Without objection, the meeting of the subcommittee is adjourned. 

Thank you. 


srobinson on DSK4SPTVN1PROD with HEARING
140 

[Whereupon, at 2:30 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


srobinson on DSK4SPTVN1PROD with HEARING
141 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 147 here 73752A.064
142 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 148 here 73752A.065
143 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 149 here 73752A.066
144 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 150 here 73752A.067
145 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 151 here 73752A.068
146 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 152 here 73752A.069
147 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 153 here 73752A.070
148 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 154 here 73752A.071
149 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 155 here 73752A.072
150 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 156 here 73752A.073
151 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 157 here 73752A.074
152 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 158 here 73752A.075
153 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 159 here 73752A.076
154 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 160 here 73752A.077
155 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 161 here 73752A.078
156 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 162 here 73752A.079
157 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 163 here 73752A.080
158 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 164 here 73752A.081
159 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 165 here 73752A.082
160 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 166 here 73752A.083
161 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 167 here 73752A.084
162 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 168 here 73752A.085
163 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 169 here 73752A.086
164 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 170 here 73752A.087
165 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 171 here 73752A.088
166 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 172 here 73752A.089
167 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 173 here 73752A.090
168 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 174 here 73752A.091
169 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 175 here 73752A.092
170 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 176 here 73752A.093
171 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 177 here 73752A.094
172 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 178 here 73752A.095
173 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 179 here 73752A.096
174 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 180 here 73752A.097
175 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 181 here 73752A.098
176 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 182 here 73752A.099
177 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 183 here 73752A.100
178 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 184 here 73752A.101
179 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 185 here 73752A.102
180 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 186 here 73752A.103
181 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 187 here 73752A.104
182 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 188 here 73752A.105
183 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 189 here 73752A.106
184 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 190 here 73752A.107
185 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 191 here 73752A.108
186 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 192 here 73752A.109
187 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 193 here 73752A.110
188 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 194 here 73752A.111
189 


srobinson on DSK4SPTVN1PROD with HEARINGInsert graphic folio 195 here 73752A.112