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FOOD AND COSMETIC PROVISIONS OF THE FOOD 

AND DRUG ADMINISTRATION GLOBALIZATION 

ACT DISCUSSION DRAFT LEGISLATION 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

APRIL 24, 2008 

Serial No. 110–108 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan, Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chair 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff 

GREGG A. ROTHSCHILD, Chief Counsel 

SHARON E. DAVIS, Chief Clerk 

DAVID CAVICKE, Minority Staff Director 

(II)

(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

HENRY A. WAXMAN, California 

EDOLPHUS TOWNS, New York 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

GENE GREEN, Texas 

Vice Chairman 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

TOM ALLEN, Maine 

TAMMY BALDWIN, Wisconsin 

ELIOT L. ENGEL, New York 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JOHN D. DINGELL, Michigan (ex officio) 

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 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

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

opening statement ................................................................................................ 4 

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

opening statement ................................................................................................ 5 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 6 

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

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

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 9 

Prepared statement .......................................................................................... 11 

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

of Pennsylvania, opening statement ................................................................... 15 

Hon. Tammy Baldwin, a Representative in Congress from the State of Wisconsin, opening statement ................................................................................... 16 

Hon. Edolphus Towns, a Representative in Congress from the State of New 

York, prepared statement .................................................................................... 18 

Hon. Darlene Hooley, a Representative in Congress from the State of Oregon, 

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

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

California, prepared statement ........................................................................... 109 

WITNESSES

Stephen Sundlof, D.V.M., Ph.D., Director, Center for Food Safety and Applied 

Nutrition, Food and Drug Administration ......................................................... 21 

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

Michael R. Taylor, research professor of health policy, Department of Health 

Policy, School of Public Health and Health Services, George Washington 

University ............................................................................................................. 57 

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

Michael Ambrosio, vice president of food safety and quality assurance, 

Wakefern Food Corporation ................................................................................ 66 

Prepared statement 1 .......................................................................................

James Lovett, corporate senior vice president, Covance Laboratories ................ 68 

Prepared statement .......................................................................................... 69 

Calvin Dooley, president and CEO, Grocery Manufacturers Association ........... 73 

Prepared statement .......................................................................................... 75 

Caroline Smith DeWaal, food safety director, Center for Science in the Public 

Interest .................................................................................................................. 82 

Prepared statement .......................................................................................... 84 

SUBMITTED MATERIAL

Discussion Draft ...................................................................................................... 111 

Food Marketing Institute, FMI, Recall Authority ................................................. 180 

Article entitled ‘‘Food Safety: The Supermarket Perspective,’’ by FMI .............. 111 

1 Mr. Ambrosio did not submit a prepared statement for the record in time 

for printing. 

(1) 

FOOD AND COSMETIC PROVISIONS OF THE 

FOOD AND DRUG ADMINISTRATION 

GLOBALIZATION ACT DISCUSSION DRAFT 

LEGISLATION 

THURSDAY, APRIL 24, 2008 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:12 a.m., in room 

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

Jr. [chairman of the subcommittee] presiding. 

Members present: Representatives Pallone, Towns, Green, 

DeGette, Baldwin, Hooley, Matheson, Dingell [ex officio], Deal, 

Buyer, Pitts, Myrick, Murphy and Barton [ex officio]. 

Staff present: Jeanne Ireland, Jack Maniko, Virgil Miller, Ryan 

Long, Nandan Kenkeremath, Melissa Sidman, Chad Grant, Brin 

Frazier, and Lauren Bloomberg. 

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

Mr. PALLONE. I call the meeting to order. 

Today we are having a hearing in the subcommittee on the Food 

and Drug Administration Globalization Act, and I will recognize 

myself initially for an opening statement. 

The draft of this legislation was released by Chairman Dingell, 

Mr. Stupak, and myself and it builds upon H.R. 3610 introduced 

by Chairman Dingell, as well as H.R. 3115 introduced by Mr. Stupak, H.R. 3484 introduced by Ms. DeGette, and my bill, H.R. 3624. 

This draft also incorporates findings from the Subcommittee on 

Oversight and Investigation of the full committee, the report released by the FDA Science Board’s Subcommittee on Science and 

Technology, the Administration’s Food Protection Plan and Import 

Safety Plan, and input from key stakeholders in the field. This 

draft is significantly different from the bill we discussed last fall 

on food safety. the Committee staff worked very hard to incorporate 

all the comments and feedback we received during and since the 

last hearing, and as a result we have before us today a more expansive discussion document. Due to its length and density of information, we have decided to hold at least two hearings so that 

we have enough time to devote to each issue, and today we will 

focus on the food-related provisions only. 

2 

Something must be done to strengthen and improve the regulation and safety of our food supply. Too often, consumers hear on 

the news about a food product recall and too often we read about 

people getting sick after consuming everyday foods like spinach 

and peanut butter. These instances are taking an enormous toll on 

consumer confidence in food items. In 2007, consumer confidence in 

the safety of food purchased in supermarkets reached its lowest 

level since 1989. A public opinion poll conducted by the Trust for 

America’s Health last year found that 67 percent of Americans are 

worried about food safety. Meanwhile, consumer confidence in the 

FDA itself is plummeting. A Harris poll conducted in 2006 indicated that only 36 percent of Americans believe the FDA is doing 

a good job, and that is down from 61 percent in 2000. 

And this is not just about consumer confidence. However, these 

instances truly endanger the American people. Each year 76 million Americans get sick due to unsafe food products. Every year 

325,000 individuals will be hospitalized and 5,000 will even die 

from foodborne hazards. It is estimated that the medical costs and 

lost productivity due to foodborne illnesses cost us $44 billion annually, and these illnesses are completely preventable, in my opinion. 

All of this raises questions about our current food safety laws, 

many of which were enacted in the 1900s. Obviously, laws that 

were written in the early 20th century are no longer current, particularly as the food industry becomes increasingly more global. 

And rather than continuing to simply react to outbreak after outbreak of contaminated products, it is about time that we put in 

place a stronger and more thorough system to prevent contaminated food products from reaching store shelves. We must work 

with players at every stage of food production from producers to 

processors to manufacturers to retailers, as well as government entities and the scientific community in order to ensure the full and 

active participation required to protect our food supply. 

In the United States today, there are 44,000 food manufacturers 

and processors and 114,000 food retailers. If you factor in international facilities, that number increases dramatically. And yet the 

FDA, the agency that is tasked with overseeing 80 percent of the 

food supply, has had to face eroding budget resources year after 

year. Not surprisingly, this has forced the FDA to cut resources. 

Since 2003, the number of FDA field staff dropped by 12 percent, 

and between 2003 and 2006, federal inspections dropped by 47 percent. As I understand it, there is widespread acknowledgement 

that the FDA is woefully underfunded. The FDA Science Board 

itself issued a report in which they deem the agency as powerless 

to improve and will be unable to complete its tasks without a significant increase in funding, and it is up to us in Congress to ensure that this agency gets the funding levels it needs to protect the 

American people. 

Now, the draft before us will generate revenue, adding to the 

funding the FDA receives through the appropriations process by requiring all food facilities to register on an annual basis with the 

FDA and pay a registration fee. This will benefit the agency in two 

ways. First, the FDA will have an up-to-date list of all food facilities, both domestically and abroad, and second, it will generate the 

3 

resources necessary to allow the FDA to conduct inspections of food 

facilities and other safety-related activities, tasks they cannot currently perform. The draft will also require each and every one of 

these facilities to have a comprehensive food safety plan that is 

available to the FDA, particularly during on-site inspections, and 

these safety plans are an important tool for preventing food safety 

problems from occurring and quickly and appropriately addressing 

incidents of contamination should something slip through the 

cracks. The draft also creates incentives for companies to be in 

compliance with food safety standards while establishing strong 

penalties for bad actors. 

We will hear testimony this morning from industry experts on 

how the provisions related to food safety in this discussion draft 

could improve the safety of our Nation’s food supply and what 

areas within this draft still need to be explored in greater detail. 

I want to thank all the witnesses. I want to especially welcome 

Mike Ambrosio, who is from my home State of New Jersey, and 

also Cal Dooley, who of course is a former Member of Congress and 

a friend. 

Mr. PALLONE. I now recognize my colleague, Mr. Deal, for his 

opening statement. 

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

Mr. DEAL. Thank you, Mr. Chairman. I want to thank you for 

providing the subcommittee with the opportunity to evaluate this 

discussion draft addressing food, drug, cosmetic and device safety. 

I think it goes without saying that a bill that is this comprehensive in nature would make very fundamental changes in the way 

the FDA regulates all of these items. Obviously, with legislation 

which includes these kinds of sweeping changes, we must take adequate care to evaluate the bill’s impact. Looking at the different 

components of this legislation separately I think helps to facilitate 

that goal, and I want to thank you for affording this opportunity. 

Like I mentioned at our hearing on food safety last September, 

I think we have all heard from constituents in our districts about 

their concerns over the safety of this Nation’s food supply and the 

products that we are importing into this country. Now more than 

ever, however, we are also starting to hear about the burden being 

faced by American families on account of rising food prices. As we 

move forward in this arena, I think we are going to have to carefully balance our desire to secure the Nation’s food supply without 

unnecessarily increasing food prices. As we work to ensure American families can have confidence in the food products they consume, I think it is critical for this committee to wrestle with the 

most cost-effective way to achieve this. Spending more money does 

not necessarily result in safer food products. 

Moreover, as we discussed at length last year during the reauthorization of the Prescription Drug User Fee Act, PDUFA, we 

seem to be moving toward a total reliance upon the regulated industry to fund the regulating agency. My limited understanding of 

some of the fee structures in this bill makes this seem more true, 

not less. There are many who are already uncomfortable with the 

FDA’s dependence on funds from the prescription drug industry, 

4 

and now it seems that we are moving the food industry in the same 

direction. These food safety issues are certainly important ones 

that we should be addressing, and I look forward to the testimony 

of our witnesses about this draft and steps that Congress should 

be taking to secure our food supply. 

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

Mr. PALLONE. Thank you, Mr. Deal. 

I recognize our vice chair, Mr. Green, for an opening statement. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman, for holding the hearing 

today on the discussion draft of the Food and Drug Administration 

Globalization Act. 

Over the past year there have been several high-profile food contamination incidents in the United States. These outbreaks also led 

the GAO to our food safety program, High Risk, and the FDA’s own 

Science Board to say the FDA does not have the capacity to ensure 

the safety of food for the Nation. Mr. Stupak and the Subcommittee 

on Oversight and Investigation had a series of hearings on the 

state of food safety which found the FDA simply didn’t have the 

money, technology, or manpower to fulfill its mission. The findings 

of this committee, the GAO, and the Science Board are alarming, 

to say the least, and most certainly indicate the FDA needs more 

resources to protect our food supply. I wholeheartedly support legislation that would improve the ability of the FDA to protect our 

food supply, and I commend the chairman of our full committee for 

the dedication to improving food safety. 

I do have concerns regarding the port-of-entry provisions in the 

discussion draft. I appreciate the fact that the Committee did make 

some changes regarding the provision from H.R. 3610, but I still 

have some concerns with the section on the port-of-entry provisions 

in the draft. I have the honor of representing Houston, and the 

Port of Houston is vital to our economy and provides thousands of 

jobs in our district as well as southeast Texas. The port is the largest port in the United States 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 products in 2007. 

The discussion draft has a provision that would allow foreign and 

domestic food facilities to voluntarily seek certification from the 

FDA, and the FDA would have a list of certified companies. After 

5 years, uncertified foreign food facilities would only be allowed to 

enter the United States at a port of entry which has an FDA lab. 

The Port of Houston does not have an FDA lab. In fact, there is 

no FDA lab in the entire State of Texas, even though we share the 

longest border with Mexico. I have yet to understand why Texas, 

with the level of trade and the 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. The 

FDA lab for the State of Texas actually is in southern Arkansas. 

Again, I don’t know how much food is imported into Arkansas since 

it is not near a border or a port. 

With regard to the discussion draft, we don’t know if foreign food 

facilities will actually register with the FDA because their registraVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
5 

tion is voluntary. If these companies choose not to register and go 

to these 13 ports with labs, I question whether the FDA can handle 

the actual certifying of all these facilities and if the FDA labs at 

the 13 ports will be able to handle an increased number of imports 

from unregistered food facilities. Therefore, I respectfully request 

the chairman of the Committee work with me to address the concerns regarding the port-of-entry provision. I don’t think we should 

pick winners and losers based on a decision that was made decades 

ago and not based in reality, of where the food products are actually imported today. 

With that, I look forward to working with you, Mr. Chairman 

and staff, and I yield back my time. 

Mr. PALLONE. Thank you, Mr. Green. 

Next I recognize the ranking member of the full committee, Mr. 

Barton, for an opening statement. 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. Thank you, Mr. Chairman. We appreciate the regular order on this bill. Having a legislative hearing on it I think 

is a good start. 

I must say, as we have discussed the issue of food safety this 

year, Chairman Dingell and myself and a number of members on 

both sides of the aisle have numerous times said that we hope we 

could work together on this issue. I am very disappointed that the 

drafting of these bills so far, Republicans have not been allowed 

any input. It does not bode well for moving legislation if we are 

given drafts that we were not allowed to have input into or expected to accept them as is. Having said that, the fact that you are 

having a legislative hearing is a good step and we hope that we 

may have some input into the process. 

I would say the bill before us needs some improvements. I would 

start with some basic principles. The bill is replete with user fees. 

If you look at the price of food and how much it has gone up just 

in the last 6 months to a year, I think we should tread lightly on 

imposing additional costs on our food industry because ultimately 

the consumers pay those costs. Yesterday’s Washington Post had a 

front page story about hunger in the world and, as food prices are 

exploding, how it is going to be more and more difficult to deal with 

just some of the basic food commodities. 

I also have a problem with the restriction of ports of entry, as 

my good friend from Texas, Mr. Green, just pointed out. We don’t 

have an FDA laboratory in Texas yet we do have a number of very 

active ports and it would seem somewhat over-micromanagement 

to restrict the imports basically to places that have these laboratories already in place. So I think that is something that we need 

to work on. 

Overall, I could go through three or four more pages of my opening statement but suffice it to say, I take Chairman Dingell at his 

word when he says that that is an important issue to him and he 

would like to move legislation. My preference on the minority side 

is to be cooperative, but in order for us to be cooperative, we have 

got to be allowed to be cooperative, and the draft bill before us we 

6 

had absolutely no input into, therefore, we have no ownership of, 

therefore we tend to look at somewhat skeptically. 

With that, Mr. Chairman, I yield back. 

Mr. PALLONE. Thank you, Mr. Barton. 

I next recognize the chairman of the full committee and thank 

him for all his work in putting together this bill and making it a 

priority. Mr. Dingell. 

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

Mr. DINGELL. Mr. Chairman, first, this is a very important hearing that we are conducting today. Second, I want to commend you 

for the hearing but also for your leadership in this very important 

matter and for the way that we have worked together on a number 

of other important matters this year. So far this committee has 

been vigorously investigating whether the Food and Drug Administration has the resources and the authorities that it needs to protect the public health. 

I want to say that, as everyone will note, we are not considering 

introduced legislation today but rather a staff draft which will enable us to gather information about the feelings and concerns of 

our people and about industries’ concerns about the situation that 

we confront. With the assistance of Mr. Stupak and Mr. Shimkus, 

we have had seven hearings to report and to investigate on tainted 

foods, with causes ranging from intentional adulteration to poor 

manufacturing processes. We found that there are enormous 

amounts of foods and other commodities coming in which the Food 

and Drug Administration cannot even begin to investigate. The 

consequences of this have been severe risk, danger, and hurt to our 

people. 

I want to observe that from what we are going to learn at these 

hearings, it is my intention to work with you, Mr. Chairman, and 

other members of this committee, first, to meet the concerns of the 

members, second, to perfect the legislation, and third, to see to it 

that legislation is introduced upon which we may commence moving with great speed and vigor in the full committee, and I want 

to observe that we have in this committee this year and last year 

been working very closely together across the aisle. My colleagues 

on the Republican side have made enormous contributions to the 

public interest and I am proud of the way that we have worked together in these matters. It is my intention that we shall continue 

to do so on this legislation. 

We have found in our investigations, and this has been confirmed 

by FDA’s own Science Board, that FDA lacks the resources and the 

authorities to adequately oversee the Nation’s food supply in the 

21st century. I would note that they have similar inability in the 

areas of prescription pharmaceuticals and other areas of the concerns of that agency. 

Now, it must be observed the agency has been less than forthcoming about its funding needs. It is evident to almost everyone 

else, however, from the experts to our constituents and people who 

are being sickened and killed by the inadequacies of that agency, 

that the agency is starved for resources and that it cannot meet its 

7 

basic responsibilities. The discussion draft that we are considering 

today will focus on our efforts to seek real legislative concerns to 

what is in fact a public health crisis. 

First, the discussion draft aims to increase the resources that the 

FDA needs to do its job. As the FDA Science Board found as a result of years of chronic underfunding, and I note this did not start 

this week, FDA does not have the capability to ensure the safety 

of the food for the Nation. The Science Board goes on to call the 

rate at which FDA inspects food facilities appallingly low and notes 

that FDA has been forced not to increase food inspections but to 

cut them by 78 percent over the past 35 years, at precisely the 

same time that food importation has increased exponentially. FDA 

estimates that at most it inspects domestic food manufacturers 

once every 10 years. Once every 10 years. The Department of Agriculture can inspect dog food manufacturers more often than Food 

and Drug can inspect the producers and makers of foods for our 

people, a curious and indefensible situation. For foreign food facilities, the situation is even worse. At its current rate of inspection, 

FDA would need more than 2,000 years to visit every plant. This 

system must change. 

Second, because we can’t just inspect our way out of the problem, 

the draft provides FDA with resources and authorities to prevent 

food safety problems before they occur. Building on legislation introduced by you, Mr. Chairman, we ask those who supply Americans their food to ensure the safety of their product, and when prevention fails, FDA must have strong enforcement tools including 

authority to order recalls, as our colleague, Ms. DeGette, and others have suggested. Many are reaping the benefits of globalization 

but we must make sure that all parts of the food chain here bear 

some responsibility as well. 

Finally, the draft provides a range of incentives for good acts in 

the global system. Many companies with reputations to protect are 

on the cutting edge of food safety. In the absence of effective FDA 

oversight, they are using their purchasing power to urge improvements in safety from their suppliers. Those who do this must be 

rewarded and we must work to assist them so that they can build 

preventive and protective measures into their products. At the 

same time, we must ferret out the bad actors who seek to game the 

regulatory system and pass off contaminated products as safe for 

consumption, as we have learned from tragic events caused in the 

not too distant past. E. coli contaminated spinach and pet foods 

spiked with melamine and lack of regulatory diligence have led to 

the deaths of people and pets, and these are only a couple of small 

examples of what is going on. 

Mr. Chairman, food, drug, device, and cosmetic safety are not 

partisan issues and it is our intention that they cannot be so. I look 

forward to working with all my colleagues on the Committee, especially our ranking member, Mr. Barton, and my Republican colleagues and also other members, as we have previously worked together on legislation important to the American people, such as the 

Consumer Product Safety Modernization Act, the National Institutes of Health Reauthorization, and I hope that we can work together to craft good, sensible legislation that provides the necessary 

resources and authority for the Food and Drug Administration to 

8 

fulfill its critical mission to protect the American people. And I 

want my colleagues here in the Committee to know that it is my 

intention to work with them to see that their concerns, whatever 

they might be, are addressed and that we can come forward with 

a bill that will be supported by the Committee with great enthusiasm. 

Mr. Chairman, I thank you for your courtesy. 

Mr. PALLONE. Thank you, Chairman Dingell. 

Next, the gentleman from Indiana, Mr. Buyer, is recognized for 

an opening statement. 

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

Mr. BUYER. Thank you, Mr. Chairman, and I will pick up right 

where Chairman Dingell left off. 

We are really going to get serious about focusing on the safety 

and efficacy of the food, drug, and medical devices. I have received 

numerous assurances from Chairman Dingell of his willingness to 

work with me on legislation that Jim Matheson and I have been 

drafting. That bill has now been introduced, and I think Chairman 

Dingell and others are very concerned about the safety of not only 

the food but also the access of America’s drug supply. 

Our delivery systems have changed dramatically with the 

globalization of food and the drug markets, and we no longer have 

the luxury of monitoring only the operations within our borders. 

We now have the challenge of ensuring the safety of facilities in 

areas of the world where criminal interests are high and the regulatory systems are very weak. Over the past year I have focused 

on the safety of drugs coming into our country and completely diverting our highly regulated drug supply chain, and I understand 

next week we will turn our attention to the drug and device sections of the discussion draft before us. I look forward to working 

with you, Chairman Dingell, and Chairman Pallone, and what I am 

asking is on behalf of Jim Matheson and I, that when you offer this 

discussion draft that you take what Jim Matheson, Gene Green, 

Mike Rogers, and I have introduced. It is H.R. 5839, and what we 

have done, Chairman Pallone, is, we have built off of the good work 

that Chairman Dingell had done when he created the paper pedigree back in 1988, and so much has advanced since 1988 with regard to technology and we need to take advantage of that and move 

from the paper pedigree, Chairman Dingell, that you created that 

can be easily adulterated, and move into the electronic pedigree, 

and Jim Matheson and I have worked hard with all industries in 

the supply chain and worked to do the very best, and I think what 

would be very prudent, what I am asking both chairmen of the full 

committee and the subcommittee, that this be considered next 

week for hearing so we can receive input. 

Chairman Dingell, you understand it was very complex when you 

laid out this framework. It hasn’t gotten any simpler and it is a 

very difficult subject to explain to someone who knows nothing 

about it. It takes a lot of time and investment, and I think it would 

be very prudent for us to incorporate that in our hearing next week 

and I would ask for your indulgence and consideration. 

With that, I yield back. 

9 

Mr. PALLONE. I am going to ask the subcommittee’s indulgence 

because of his time constraints and being on the same subject as 

Mr. Buyer if we could ask—I will ask unanimous consent to let Mr. 

Matheson go out of order. So ordered. 

The gentleman from Utah is recognized. 

Mr. MATHESON. Actually, Mr. Chairman, if I could waive my 

opening statement and use that during my question time, that is 

what I would like to do. 

Thank you very much, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Ms. DeGette. 

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

Ms. DEGETTE. Thank you very much, Mr. Chairman. I ask unanimous consent to put my full statement in the record. 

I want to commend you and Chairman Dingell as well as Chairman Stupak and Ranking Member Barton for the way the Committee has conducted itself with regards to food safety over the last 

year. This is a really complex issue and it is one that demands a 

thoughtful and reasoned response, and that is why we have had all 

the number of hearings we have had in the Oversight and Investigation Subcommittee. Now we have the draft legislation and the 

hearing today and so I think it is really wonderful the process we 

are using. 

I also want to thank Chairman Dingell and his staff for incorporating the provisions of my legislation granting the FDA mandatory recall authority in the case of an outbreak. I often talk to my 

constituents about the fact that when there is tainted food on the 

shelves, the FDA has absolutely no authority to order a mandatory 

recall, and I think that a mandatory recall can give us two good 

results. The first one is obviously that if you have a recalcitrant 

producer who will not voluntarily recall products, then you can 

mandatorily recall it, but in addition, I think the threat of a potential mandatory recall actually will put pressure on food manufacturers and distributors to make the food safe in the first place, because in truth, while mandatory recall is important, we want to 

have the food safe before it is recalled to begin with, and so I think 

that that is an important provision of this bill. It was kind of an 

edgy leap to put it in there and I think it is important that that 

be part of any strong food safety legislation. 

The second thing I would like to discuss which is not in the draft 

legislation and I think also would be very effective is legislation I 

have introduced, H.R. 3485, the TRACE Act, and what that does 

is, it sets up a food traceability system. We all remember the outbreak of E. coli in spinach a couple of years ago and there was a 

voluntary recall, but it took weeks and weeks to discover the source 

of the problem. In the meantime, spinach producers all around the 

country with perfectly fine facilities and good produce lost tremendous profits. What we learned in our hearings in the Oversight and 

Investigation Subcommittee is that in fact we have the ability to 

trace food. In fact, some of the organic food producers and other 

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sumers could walk into a store and see a lot number or some kind 

of a number where we could trace that food back to the source, we 

would have an ability then to make sure that our food products, we 

could find where the problem was, we could identify it, and then 

we could do the recall or whatever we needed to do right away. 

So I am hoping I can work with you, Mr. Chairman, and the rest 

of the Committee to include the provisions of that legislation as 

well in any final bill that we introduce. Thank you very much. 

[The prepared statement of Ms. DeGette follows:] 

11 

12 

13 

14 

15 

Mr. PALLONE. Thank you. 

I recognize Mr. Murphy of Pennsylvania for an opening statement. 

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

Mr. MURPHY. Thank you, Mr. Chairman. 

This Congress we have had six Oversight and Investigation hearings regarding food safety, and this is the second hearing in this 

subcommittee looking at potential legislative remedies for food 

safety. I think these hearings have given us substantial evidence 

of the need to increase the safety of our food supply when you look 

at some of the things that have occurred, such as 76 million people 

who contracted foodborne illness in the United States each year 

and about 325,000 require some hospitalization; about 5,000 die, 

according to a 2007 GAO study. In the first 2 months of this year 

alone, the Department of Agriculture has issued 5 recalls on top of 

58 in 2007 and 34 the previous year. This number increases substantially when you factor in FDA recalls, and of course, we just 

experienced the largest beef recall in U.S. history of 143 million 

pounds, including 50 million pounds that have been sent to federal 

nutrition programs, including school lunch programs. We continue 

to have problems ensuring the safety of food imports. In July of 

last year, California issued a recall of imported Chinese ginger 

after discovering it had been treated with a dangerous pesticide. 

With a shaky track record on products ranging from tires to toothpaste, I think we can all agree allowing imported Chinese food with 

lax oversight is a substantial problem. 

Although America is an envy of other nations in terms of what 

we have in food and farm safety, the question remains, how do we 

remedy the problem with our food supply without unduly taxing 

the near 300,000 food facilities in this country? I have serious concerns about the legislation before us today, but it begins the process of finding a legislative solution and I welcome the debate. 

I have toured many facilities in my district and I know the tight 

profit margins many of them operate under. Registrations and the 

additional regulations could severely impact these local businesses. 

Let us also keep in mind the expense to them and the expense 

passed on to consumers with food. U.S. food prices rose 4 percent 

in 2007, and in 2008, it is expected to be even worse. Eggs cost 25 

percent more in February than they did a year ago. Milk and dairy 

products are up 13 percent. Poultry is 7 percent higher, according 

to the USDA. Flour used to make bread was selling at $16 a hundredweight last summer and it is up to the 40s and expected to go 

to some $60. 

Keep in mind also these overlap with our energy issues. The 

grain needed to fill a 25-gallon tank with ethanol would, according 

to Lester Brown, feed one person for a year, and filling that tank 

every two weeks would feed 26 people. So any impact we have upon 

cost of U.S. food supplies and other food supplies are affected 

around the world. 

Keeping all these challenges in mind, I look forward to working 

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work without unduly burdening small businesses, and most importantly, without unduly burdening every family and the cost of their 

grocery basket. 

I look forward to the testimony of today’s witnesses, and I yield 

back. 

Mr. PALLONE. Thank you. 

Next is the gentlewoman from Wisconsin, Ms. Baldwin, recognized for an opening statement. 

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

Ms. BALDWIN. Thank you, Mr. Chairman, and thank you very 

much for holding this important hearing. I want to commend you 

and Chairman Dingell and Chairman Stupak for putting forward 

this discussion draft that addresses the very serious challenge we 

face with respect to food and drug safety. 

The fact that our Nation faces a very serious food safety concern 

is not in question. We all know about many of the incidents that 

have been related by previous speakers—tainted spinach, peanut 

butter, and just recently in March of 2008 we had salmonella-tainted cantaloupe in several states, including my home State of Wisconsin, that caused several people to fall ill. 

But there are questions that do need to be asked and they include, what additional authorities does the FDA need to ensure the 

safety of our food supply? Does the FDA have sufficient resources 

to carry out appropriate food safety measures? What steps can we 

take to prevent food contamination incidents before they occur? 

And in an increasingly interconnected world, how do we ensure 

that food coming in from other countries is safe? And I think that 

the Dingell-Pallone-Stupak discussion draft addresses these questions in a thoughtful and constructive manner. I strongly agree 

that the FDA is in critical need of increased resources to ensure 

the safety of our Nation’s food supply. We must take steps to make 

sure that this need for resources is met, and I support the draft 

provisions that provide those much-needed resources. 

I am also pleased that the discussion draft includes a provision 

that would allow the FDA to partner with accredited third-party 

laboratories to perform testing. This partnership will expand the 

FDA’s laboratory testing capacity and will result in more food 

being tested. This is a smart way to harness the abilities of the private sector and a smart way to expand the FDA’s food safety efforts without draining the already very scarce resources of the 

FDA. 

Lastly, Mr. Chairman, I would like to extend a special welcome 

and thank you to James Lovett, who is one of our witnesses today. 

Mr. Lovett is testifying on behalf of Covance, a company that has 

more than 60 years of food testing experience, among other things 

that they do, and it has a very large and impressive facility in my 

home district and hometown of Madison, Wisconsin. I am pleased 

that they will be able to communicate with us today and share 

their unique perspective in this debate and the role that they play 

in ensuring the safety of our Nation’s food, and I look forward to 

today’s discussion. 

17 

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

Mr. PALLONE. Thank you. 

Next for an opening statement, the gentleman from New York, 

Mr. Towns. 

Mr. TOWNS. Thank you very much, Mr. Chairman. I would like 

to place my opening statement in the record. 

[The prepared statement of Mr. Towns follows:] 

18 

19 

20 

Mr. PALLONE. Thank you. 

The gentlewoman from Oregon, Ms. Hooley. 

OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Ms. HOOLEY. Thank you, Mr. Chair. Thank you for holding this 

hearing and for providing this discussion draft of the Food and 

Drug Administration Globalization Act legislation. 

Mr. Chair, I think it is safe to say that everyone in this room 

and, for that matter, everyone listening to or watching this hearing, wants our food system to be safe and safer than it currently 

is. It is clear to me that the first order of business is to increase 

the resources available to the FDA. As this committee has pointed 

out on a number of occasions, FDA’s own Science Board refused to 

address the role of science in the agency’s work without first addressing the historic lack of resources for the agency as a whole. 

I do, however, have some issues with the user fees as set up by this 

legislation, which I will get to in a minute. 

I am also pleased that the bill tries to direct the FDA and the 

food industry to prevent problems before they occur. That makes 

sense from the point of view of the consumer who does not want 

to get sick to prove anyone’s point, as well as from the point of view 

of the industry that does not want to go bankrupt facing a major 

product recall. 

The third item in this bill that I am pleased about is the attempt 

to provide flexible authorities for the enforcement of food safety 

standards. That is going to help improve industry standards and 

ensure compliance without the need for overbearing enforcement 

provisions. 

I do, however, have a few concerns about the discussion draft 

that I think need to be addressed. Let me sum them up. This bill 

as it currently stands would competitively disadvantage small food 

producers and processors, leave Oregon in the position of having 

zero ports of entry for imported foodstuffs and inadvertently increase energy usage to get out food. But let me emphasize the issue 

is so important and your work on it to date is so laudable that I 

want to work hard to resolve these issues and arrive at a bill that 

I can support and that we can pass out of committee. 

First, if we must go the road of user fees, then the fees must be 

on a sliding scale, or processors below a certain size should be exempt altogether from the fee. Two thousand dollars is cost-prohibitive for many of my small food processors. Many people in Oregon 

are turning toward local food producers and processors to get the 

freshest, best food while using the least amount of energy to get 

it. The way this user fee is set up puts those producers at a disadvantage. I also believe that registration of these facilities may already be required by other federal legislation, for example, the Bioterrorism Act of 2002, and I wonder about duplicating efforts. 

Second, I have concerns about the country of origin labeling provisions. I want to thank you for changing the COOL provisions 

from unworkable to workable. We are almost there but not quite. 

We need to work on the definition of processed food since it varies 

from the Bureau of Customs and what is proposed in the Farm 

Bill. We also need to clarify who is responsible for listing ingrediVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
21 

ents on whose Web site and is the ingredient listed per the time 

of year it is available or is it tied to a particular package. There 

are lots of details to be worked out and I look forward to working 

with them and with you and your staff. 

Third, I am extremely concerned about the provisions that limit 

eventually the importation of food only through ports with an FDA 

or FDA-certified inspection and testing facility. Oregon does not 

have one, not even at the Port of Portland, which would mean that 

all of our food importation business would be sent to California or 

Washington. That means the loss of business to Oregon ports but 

it also means in this time of ever-increasing gas prices that the cost 

of food will include the increased use of gas to get that food from 

California and Washington to Oregon. I thought we were supposed 

to be encouraging the decrease of energy, not passing a policy that 

requires the unnecessary increased use of gas. 

Lastly, I am very concerned that these policies combined, the 

registration fees, the importation requirements, the labeling requirements, will work against my small food producers. In Oregon, 

folks pride themselves on innovation, and I would not want the 

pursuit of food safety to be the death knell for locally produced, locally consumed fresh foods. I have more details from the food safety 

division of the Oregon Department of Agriculture that I would submit for the record. 

I look forward to working with you, Mr. Chair, and my colleagues 

to resolve these concerns. Thank you. 

Mr. PALLONE. Thank you, and I believe that concludes the Members’ opening statements so we will now turn to our witnesses, and 

I would ask the first panel, which is the FDA representatives, to 

come forward please. 

Thank you for being here today. On our first panel, we have Dr. 

Stephen Sundlof, who is director of the Center for Food Safety and 

Applied Nutrition at the FDA, and accompanying him is Dr. Steven 

Solomon, who is deputy director of the Office of Regional Operations in FDA’s Office of Regulatory Affairs. 

Let me mention that we have 5-minute opening statements. Is 

just one of you going to speak? OK. So a 5-minute opening statement is from the witness, and that becomes part of the hearing 

record. The witness may in the discretion of the Committee submit 

additional brief and pertinent statements in writing for inclusion in 

the record, and I would now recognize Dr. Sundlof. 

STATEMENT OF STEPHEN SUNDLOF, D.V.M., PH.D., DIRECTOR, 

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, 

FOOD AND DRUG ADMINISTRATION 

Dr. SUNDLOF. Good morning and thank you, Chairman Pallone 

and members of the Subcommittee. I am Stephen Sundlof, director 

of the Center for Food Safety and Applied Nutrition at the Food 

and Drug Administration, and I appreciate the opportunity to discuss our legislative proposals as well as proposals developed by you 

and your colleague on the Committee to enhance FDA’s ability to 

carry out its important public health mission. 

Food can become contaminated at many different steps along the 

path from farm to fork. In recent years, FDA has done a great deal 

to prevent both deliberate and unintentional contamination of food 

22 

at each of these steps. However, changes in consumer preferences, 

changes in industry practices, and the rising volume of imports 

have posed challenges that require us to adapt our current food 

protection strategies. 

To address these challenges, last November, Secretary of Health 

and Human Services Michael Leavitt presented to the President an 

Action Plan for Import Safety which reflects the input of 12 departments and agencies and provides recommendations to enhance the 

safety of imported products. In conjunction with the Action Plan, 

FDA released a Food Protection Plan which provides a framework 

to identify potential hazards and counter them before they can do 

harm. Together these plans provide an updated and comprehensive 

approach to ensure that the U.S. food supply remains one of the 

safest in the world. The plans encompass three core elements: prevention, intervention, and response. The prevention element means 

promoting increased corporate responsibility so that food problems 

do not occur in the first place. The intervention element focuses on 

risk-based inspections, sampling, and surveillance at all points in 

the food supply chain. The response element bolsters FDA’s emergency response efforts by allowing for increased speed and efficiency. 

Consistent with the goals of the Action Plan, in December, HHS 

and the People’s Republic of China signed a Memorandum of 

Agreement to enhance the safety of food and animal feed products 

exported from China to the United States. The Memorandum of 

Agreement establishes a bilateral mechanism to provide greater information to ensure products from China meet U.S. standards for 

quality and safety. The key terms of the agreement include enhanced registration and certification requirements, greater information sharing, faster access to production facilities, and the implementation of key benchmarks to evaluate progress. The first formal bilateral meeting under the Memorandum of Agreement was 

held in Beijing last month. 

FDA has also made a commitment to station inspections and 

other agency representatives in China to increase our ability to 

carry out foreign inspections and to facilitate cooperation between 

FDA and its counterpart regulatory authorities. FDA is considering 

endeavors similar to this in other countries. 

In the plans we identified several new legislative authorities 

needed to help us fully implement them. For example, FDA is requesting the authority to require entities in the food supply chain 

to implement measures solely intended to protect against intentional adulteration of the food supply by terrorists or criminals. 

We are also requiring explicit authority to issue regulations requiring preventive food safety controls for high-risk foods. Such authority would strengthen FDA’s ability to require manufacturers to 

implement a risk-based Hazardous Analysis and Critical Control 

Point, or HACCP, or equivalent process to reduce foodborne illnesses from these foods. 

Some of the other legislative proposals include authorizing FDA 

to accredit and use highly qualified independent third parties to 

evaluate compliance for voluntary inspections, allowing the FDA to 

move the inspection of high-risk products of concern upstream by 

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party inspector to certify each shipment for compliance with FDA’s 

standards prior to shipment, giving FDA authority to issue mandatory recalls if a voluntary recall is not effective, authorizing the 

FDA to refuse admission of imported food if inspection access has 

been delayed, limited or denied, and giving FDA enhanced access 

to food records during emergencies 

We commend the members of this committee and their staff for 

developing the discussion draft entitled ‘‘The Food and Drug Administration Globalization Act of 2008.’’ We recognize and appreciate the Committee’s efforts to include new authorities requested 

by the Administration in support of the Action Plan for Import 

Safety and the Food Protection Plan. 

We are in the process of reviewing the discussion draft in detail, 

and we look forward to working with you on this legislation. At this 

time, however, we can make some general comments that guided 

the development of the Action Plan for Import Safety and which we 

believe should also guide the development of product safety legislation. 

First, any legislation should allow FDA to set requirements and 

priorities based on a strong scientific risk assessment. Given the 

breadth and scope of the food products imported into the United 

States, FDA cannot rely on inspections as its primary means of ensuring food safety. Any legislation should build on the framework 

in the plans to build in safety measure to address risks throughout 

the product’s life cycle and focus efforts on preventing problems 

first and then use risk-based interventions to ensure preventive approaches are effective coupled with a rapid response as soon as contaminated food or feed is detected or when there is harm to people 

or animals. 

The Federal Government should be striving to address food safety concerns while minimizing the potential effects on the increasing 

costs of food. While the Administration is supportive of user fee 

programs in which regulated industries provide funding for additional performance and efforts or programs designed to recoup the 

costs of enforcement actions such as reinspections, the Administration will carefully review any proposed user fee to ensure that it 

is being assessed against identifiable recipients for special benefits 

derived from federal activities beyond those received by the public. 

Any legislation should be carefully designed to avoid creating 

real or perceived barriers. Any legislation should empower robust, 

voluntary private sector efforts already underway. 

With these in mind, we believe that the proposed legislation 

should be more closely targeted and prioritized according to risk. 

Several of the legislative sections are not exclusively targeting 

high-risk products. Some of these requirements would require such 

substantial resources that they would not be feasible. Further, such 

resources could detract from more important food safety and food 

defense priorities. 

In addition, the legislation should more explicitly incorporate the 

Administration’s strategy of leveraging efforts underway by certifying bodies and foreign nations. Finally, several provisions of this 

bill may need to be reviewed in light of U.S. agreement obligations, 

and we are reaching out to the United States Trade Representative 

for further insight on these. 

24 

Thank you again for the opportunity to discuss FDA’s legislative 

proposals as well as the proposals developed by the Committee. We 

look forward to working with you to obtain passage of the requested legislative authorities identified in the Food Protection 

Plan and the Action Plan for Import Safety, and I would be happy 

to answer any questions at this time. 

Thank you, Mr. Chairman. 

[The prepared statement of Dr. Sundlof follows:] 

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30 

31 

32 

33 

34 

35 

36 

37 

38 

39 

40 

41 

42 

43 

Mr. PALLONE. Thank you, Dr. Sundlof. 

I will recognize myself for 5 minutes for questions. I have two 

questions. I am going to try to get in one about the funding and 

one about your authority, so just bear with me so we can get both 

of those in. 

The draft legislation incorporates some of the suggestions your 

agency made in its recently released Food Protection Plan, and 

those are strong concepts and things the FDA should be doing to 

protect the American people. But we know for a fact that the FDA 

is underfunded. Commissioner von Eschenbach even recently stated in an interview that you have requested more than the 2.95 percent overall increase for the FDA that was proposed by the Administration, and former FDA Commissioner and CMS Administrator 

Mark McClellan stated, and I quote, ‘‘The President’s fiscal 2009 

budget barely gives FDA enough funds to operate at last year’s 

level and does little to make up for the steady loss of staffing that 

the agency has endured for the past decade.’’ 

So my first question, in your professional judgment, how much 

money does the FDA need to carry out the tasks laid out in your 

plan and also in this bill? 

Dr. SUNDLOF. Thank you, Mr. Chairman. Well, first of all, a lot 

of it has to do with the authorities that we are going to be given. 

If we do acquire some of these authorities, it will make a big difference on the amount of revenues and resources that we are going 

to need. For instance, if we have the authority to recognize thirdparty inspectors, then we would expect that the number of inspections that would be required by FDA, we would be relying on those 

third parties to do a lot of the inspection work for us. That doesn’t 

mean that there aren’t costs associated with that. We would have 

to certify those third parties to make sure that they are inspecting 

in accordance with our regulations. But it is very difficult at this 

point to say exactly how much additional revenues we will be needing until we have a clearer picture of what new authorities that we 

have already declared we need in order to—— 

Mr. PALLONE. Well, do you want to make a distinction between 

your plan versus this bill? I mean, I know this bill you are just seeing in the last few days, but do you want to talk about the cost 

of additional money under your plan at least? 

Dr. SUNDLOF. Well, under our plan, again, we would have—it depends again on the amount of inspection that is going to be required. Under this particular plan, the Globalization Act, it would 

basically require that every food manufacturer in the world that 

exports to the United States would have to be inspected at a fairly 

regular frequency, either 2 or 4 years. 

Mr. PALLONE. Do you have cost estimates for your plan anywhere 

in the agency at this point you could give us? 

Dr. SUNDLOF. We don’t have cost estimates at this time. The 

plan that we were talking about said that we would take a tiered 

approach, that we would have more frequent inspections for those 

high-risk plants and fewer inspections for plants that—— 

Mr. PALLONE. Well, let me just ask you this because I want to 

get to the second question. If you can at some point—I am sure at 

some point you are going to put some kind of cost on your plan— 

44 

get back to us because obviously the amount of funding is a big 

issue here in terms of how we pay for it. 

In your testimony, you mentioned three core elements that are 

vital to ensuring a safe food supply including concepts like prevention, intervention, and response and, while prevention is very important to me and is a central theme in my bill on food safety, I 

don’t think we should be just reacting to instances of contaminated 

food but instead we should make sure things—we should make 

sure those instances never happen in the first place. And yet at the 

same time, in your testimony you are only asking for authorities 

in specific areas such as the power to protect against the intentional adulteration of food and for high-risk foods. However, the recent outbreaks have not been intentional nor have they solely affected high-risk products, and yet Americans are still dying from 

foodborne illnesses. So my question is, does the FDA currently have 

the authority to protect the American people from low-risk, non-intentional outbreaks, and if not, what authorities do you need to do 

so, to provide those protections? 

Dr. SUNDLOF. Thank you, Mr. Chairman. We do have the authority to protect the public against both high and low risk. What we 

are requesting in the Food Protection Plan and Import Safety Action Plan is the authority to explicitly require that companies that 

have higher-risk foods that they are producing have plans in place, 

written plans in place that we can audit against to make sure that 

they are following a preventive program so that contaminated food 

does not get to the public. Now, for lower-risk plants, we would encourage those low-risk plants to also have similar preventive measures in place. We think that in order to make the maximum use 

of our resources, that we should be targeting those firms that 

produce high-risk products. 

Mr. PALLONE. So essentially you have the authority, in your 

opinion, for both right now but you are focusing on high risk? 

Dr. SUNDLOF. We are focusing on, we would like to have explicit 

authority to require firms that produce high-risk foods to have 

plans in place and documented so that we can inspect against those 

particular plans. Right now that authority is explicit for seafood 

and I believe at least seafood and other high-risk products there is 

no explicit authority for that. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia. 

Mr. DEAL. Thank you. 

Dr. Sundlof, one of the concerns that you have already heard expressed from members here in opening statements and one that my 

State would have a concern about too is the lack of FDA inspection 

facilities adjacent to our ports of entry. Would you briefly address 

that concern and how would you propose to deal with the concern 

about having inspection facilities available at ports of entry? 

Dr. SUNDLOF. Yes, so laboratory facilities at ports of entry. 

Mr. DEAL. Yes. 

Dr. SUNDLOF. Well, I can just say that depending upon what 

kind of food is imported into the United States, it may not make 

a difference whether or not there is a laboratory there because that 

laboratory may not be doing the types of analysis that we would 

require. For instance, if it was seafood and the particular laboraVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
45 

tory was only looking at things like pesticide residues, it wouldn’t— 

there would be no effect on having a laboratory right there. We believe that with the rapid transportation that is available today that 

products can be shipped from the port of entry to any of our laboratories within 24 hours, and that really doesn’t represent a problem 

for us. 

Mr. DEAL. Well, obviously, as you have already heard, States are 

very concerned about their own competitiveness in terms of what 

may be mandated for inspections that will dictate laboratory analysis. I think that is one of those concerns that all of us are going 

to have to be very aware of in terms of anything legislatively mandated in that regard. My State, for example, as I understand, does 

not have a laboratory except in Atlanta, Georgia, which is very 

much inland from our ports. So that will be a concern that you are 

going to continue to hear, I think, and something that as a practical matter all of us both at the legislative level and at the enforcement level need to look at very carefully and have a more 

thorough understanding. 

In that regard, could you expound just a little bit about the existing agreements with other countries in terms of, you indicated that 

the authority to rely on the exporting country to certify safety is 

an important element in this whole process. How successful do you 

think that currently is? What needs to be done? If we need to beef 

up that end of it, what needs to be done there? 

Dr. SUNDLOF. Thank you. Currently the only agreement that we 

have underway is with China and we have just begun that process, 

and we have identified certain high-risk foods, seafood being one of 

them, that we would require that the Chinese government certify 

to our standards that those products were safe before they ever left 

the port. We are considering similar agreements with other countries for which we have concerns about their ability to ensure that 

the food is safe. What we have asked for in the Import Safety Action Plan is the explicit authority to require certification from other 

countries as a condition of them being able to export to the United 

States. 

Mr. DEAL. Obviously that could potentially impact trade agreements and other matters, and you indicated that consultation with 

the U.S. Trade Representative Office was one of the areas that 

needs to take place, and I agree with that. Would you, after you 

and your staff have consulted with USTR, would you be willing to 

come up and brief us staff-wise and members who are interested 

on what those kind of trade implications might be and areas of concern that we should be aware of in that regard? 

Dr. SUNDLOF. Certainly. 

Mr. DEAL. I think that would be very helpful for us to have a 

pretty detailed understanding of the interaction between all of 

these things as it relates to what we are trying to legislatively 

achieve here. 

Thank you, and I would yield back my time. 

Mr. PALLONE. Thank you, Mr. Deal. 

Recognize Chairman Dingell for 5 minutes for questions. 

Mr. DINGELL. Mr. Chairman, I thank you for your courtesy. 

These questions to the Food and Drug Administration. The 

Science Board estimated that over the past 35 years your inspecVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
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tion capability has fallen 78 percent because of cuts in funding. In 

addition, they estimated that you inspect food manufacturers once 

every 10 years. They also estimated that you made only 96 overseas food inspections last year out of a potential for 180,000 or 

more facilities that needed inspection. Are these statements true? 

Dr. SUNDLOF. I believe they are, sir. 

Mr. DINGELL. All right. Now, let us look at your situation. You 

have the unfortunate situation that you have received huge cuts so 

your ability has declined enormously over that period of time. You 

now do not know what the additional burdens imposed on you by 

this bill will do. I am asking you at this time to submit to us in 

writing at your earliest convenience a statement of what you need 

to carry out your current responsibilities, and second, what you will 

need under this bill to carry out the responsibilities imposed upon 

you. Can you give me a quick and dirty answer as to what you will 

need to bring yourself current with your present responsibilities 

under law in terms of inspecting food-producing establishments? 

How much? 

Dr. SUNDLOF. I don’t have a number for you. 

Mr. DINGELL. Then we will send you a letter and I will expect 

that you will give us a response. 

Mr. Chairman, I ask unanimous consent that the record remain 

open for that to be inserted. 

Mr. PALLONE. Without objection, so ordered. 

Mr. DINGELL. Now, tell us, please, about what the additional responsibilities will be as asked about by our very able chairman. 

Dr. SUNDLOF. Well, the additional responsibilities both in the 

Food Protection Plan and the Import Safety Action Plan and in the 

bill that we are discussing today is going to be that we will take 

on a new role and that is as a certifying body, that we will certify 

other, whether it is a foreign government, whether it is a State 

agency, or whether it is a private industry, private sector industry, 

to inspect to our standards. 

Mr. DINGELL. In order to enable us to make a proper appraisal, 

we will also include that question and you give us a more detailed 

and thoughtful answer on that. 

Now, I would like to address risk-based systems and information 

and structure. According to the Science Board, FDA lacks information science capability and information infrastructure to fulfill its 

regulatory mandate. They found that there is insufficient capability 

in modeling risk assessment and analysis. Are you familiar with 

that statement? 

Dr. SUNDLOF. I am familiar with the statement, sir. 

Mr. DINGELL. The report goes on to state FDA IT infrastructure 

is obsolete, unstable, lacks sufficient controls to ensure continuity 

of operations or to provide effective disaster recovery services, and 

they go on to observe that, given the lack of dependable IT infrastructure, an eroding science base, and a dwindling workforce, they 

raise questions about whether FDA can effectively model risk to 

evaluate food shipments entering the interstate commerce currently. Are you familiar with that? 

Dr. SUNDLOF. Yes, sir, I am. 

Mr. DINGELL. Do you agree with that or disagree with it, yes or 

no? 

47 

Dr. SUNDLOF. Well, I don’t completely agree with that. We have 

put a lot of emphasis in fact when we announced—— 

Mr. DINGELL. Just simply, because our time is limited, do you 

agree or disagree? 

Dr. SUNDLOF. I disagree with the entirety of the statement, not 

with the—let me restate that. I don’t disagree with the entirety of 

the statement. There are certain statements within that that I do 

disagree with. 

Mr. DINGELL. Now, you have down there two different systems 

of handling your data and information, do you not? 

Dr. SUNDLOF. I am not sure what you are referring to. 

Mr. DINGELL. Please submit the answer to that for the record. I 

believe you do. 

Now, Commissioner von Eschenbach stated before the National 

Press Club in February of 2008 that he will continue to make his 

staff available day or night to work with Congress on food safety 

legislation. Tell me when the Administration will have its comments to us regarding the discussion draft. 

Dr. SUNDLOF. I don’t have a time frame. I know that we are 

working—— 

Mr. DINGELL. I would like it at your earliest convenience. 

Mr. Chairman, just one more question. 

You state in your testimony that any legislation should empower 

robust, voluntary, private sector efforts and that such is already 

underway. Is that correct? 

Dr. SUNDLOF. That is correct. 

Mr. DINGELL. My time is expired, but I want you to submit to 

us a clear statement of what that means and what you are in fact 

doing to give us these robust voluntary private sector efforts that 

are already underway. 

Mr. Chairman, I thank you for your courtesy. 

Mr. PALLONE. Thank you, Chairman Dingell. 

Ranking Member Barton is recognized for questions, 5 minutes. 

Mr. BARTON. Thank you, Chairman Pallone. I have been watching the hearing on my television set as I was in a series of private 

meetings so I somewhat kept up with the hearing although I 

haven’t been here in person. 

Dr. Sundlof, has the FDA taken any kind of an official position 

on the bill that is the subject of this hearing today? 

Dr. SUNDLOF. No, the Department has not taken an official position. 

Mr. BARTON. If you read your testimony, one could interpret that 

the FDA would prefer, instead of a strict regulatory approach, more 

of a risk-based approach. Is that a fair statement? 

Dr. SUNDLOF. Yes, it is a fair statement that we would prefer to 

use our resources to apply to the highest risk areas rather than a 

broad, across-the-board inspection program. 

Mr. BARTON. Do you see a possibility, since this is a discussion 

draft, to have a meeting somewhere in the middle between the approach in the bill before us and the approach where you have limited assets and you apply those more risk-based approaches? Is 

there a possibility to meld those two together? 

Dr. SUNDLOF. I would certainly hope so. 

48 

Mr. BARTON. I would too. Would you care to comment on the use 

of third parties for certain functions as opposed to having everything be done directly by paid employees of the FDA? 

Dr. SUNDLOF. Well, sir, I think it is impractical, especially when 

we are talking about foreign inspections, to think that the FDA 

could possibly cover 150 different countries and somewhere between 140,000 and 180,000 different manufacturers. First of all, it 

would require that we had agreements with all those foreign governments to go in and inspect but the reality of that situation is 

that if everybody took that approach, then every country would be 

inspecting every other country and it would be a continuous string 

of inspections that would go on and I don’t see how a company 

could actually produce food under those conditions because they 

would be constantly inspected by every country. So we believe, and 

I think it is consistent with the proposed legislation, that we rely 

on either foreign governments to certify according to our standards 

or third party independent folks to certify to our standards and 

that we would have an auditing function to make sure that they 

are in compliance with our standards. 

Mr. BARTON. Is it fair to say that the approach you just outlined, 

if I understand correctly, is used right now on the drug side? Don’t 

you have that same approach for inspecting drugs and drug ingredients? 

Dr. SUNDLOF. We do with a few countries under mutual recognition agreements, not all countries but more and more. We are looking to other countries if we believe they are equivalent to our system, and utilizing the information that they gather from their inspections. 

Mr. BARTON. But there would be a precedent on the drug side in 

some countries? 

Dr. SUNDLOF. Yes. 

Mr. BARTON. All right. What is your view of the proposal that all 

food imports have to come into certain ports that already have an 

FDA laboratory? 

Dr. SUNDLOF. Well, again, our food laboratories are scattered 

throughout the United States, not always associated with ports of 

entry, and that different types of testing and sampling occur in 

various parts of the United States. So even if the import did come 

to a port where there was a laboratory, there is no guarantee that 

that laboratory could actually run the analysis that we would want 

and so we would still have to ship that sample to another laboratory in the United States that specialized in that particular testing. 

So at least from my view is that it doesn’t gain us very much, requiring that the particular port have a laboratory. 

Mr. BARTON. My time is about to expire. My last question, if I 

understand the bill correctly, it also restricts the ability of the FDA 

to reorganize or relocate any of these food inspection laboratories. 

In the 21st century, do you think that is good public policy to put 

that kind of a restriction into law? 

Dr. SUNDLOF. Mr. Chairman, I think that we always want to preserve our flexibility in the FDA to put our resources where we 

think they will serve in the best interest of the public. 

Mr. BARTON. Thank you, Chairman Pallone. 

Mr. PALLONE. Thank you, Mr. Barton. 

49 

Next is our vice chair, Mr. Green, recognized for questions. 

Mr. GREEN. Thank you, Mr. Chairman, and I think some of the 

questions I have may have been answered, but Doctor, you heard 

my opening statement. I have the Port of Houston and we don’t 

have a lab. In fact, we don’t have one in the State of Texas, even 

though we have the biggest land port I guess in the world, in Laredo and Nuevo Laredo, Texas, for goods including foodstuffs. Do 

you happen to know what the lab in Arkansas’s specialty is? Is it 

really food testing or is it something else the FDA may be doing? 

Dr. SUNDLOF. I am going to ask Dr. Solomon to respond to that. 

Dr. SOLOMON. They do do food in the Arkansas lab, among other 

areas, but food testing is one of their areas. 

Mr. GREEN. And I don’t know who put the lab there but I can 

imagine if it was a Member of Congress, somebody from southern 

Arkansas many decades ago, and I understand how that works and 

that is why if the bill makes some changes, it should recognize that 

there are ports that have a great deal of foodstuff coming in, and 

I know you can oversight stuff and I know the bill hopefully will 

call for alternative certification at independent labs that are certified and would not pick winners and losers in a bill based on the 

13 lab locations. 

The FDA’s use of voluntary registration or certification before 

they regulate food and drugs, and are these labs able to handle the 

current workload or with this increased workload that you would 

have? Now, I have to admit, I have been on the docks at the Port 

of Houston and had FDA inspectors there with me, so we have inspectors on the docks. 

Dr. SUNDLOF. Again, I am going to ask Dr. Solomon to respond 

to that. 

Dr. SOLOMON. We are always looking at our laboratories and 

other activities to see their capacity, their capability, their timeliness of doing work, and we are continually evaluating how we can 

improve that because testing is one component of trying to get assurances about the safety of food, so we are handling our current 

workload. We understand that there is more work that needs to be 

done and we are looking to obtain additional efficiencies by trying 

to improve the laboratory capabilities, capacity, and their timeliness. 

Mr. GREEN. And the last thing is, I know this bill provides additional funds for the expansion, and would the FDA, with these 

funds, intend to add more labs and particularly locations that have 

a great deal of imports that you would need, and would you consider locating them in areas that have that high food import or 

trade levels? 

Dr. SUNDLOF. Right now I don’t believe that we have made any 

kind of decisions about increasing laboratory capability. One of the 

things we are considering is recognizing independent laboratories 

and accrediting those laboratories to conduct analysis that would 

supplement the work that is currently done in the FDA laboratories. 

Mr. GREEN. And I know the cost issue, if it costs so much to do 

at an independent lab, that it would be maybe cheaper to actually 

establish an FDA lab in a location if you have enough business to 

do it. 

50 

Dr. SUNDLOF. It is certainly something that we would consider. 

Mr. GREEN. Thank you, Mr. Chairman. I yield back. 

Mr. PALLONE. Thank you, Mr. Green. 

The gentleman from Indiana, Mr. Buyer, for questions. 

Mr. BUYER. Thank you. 

To either of you, do you think it is important to have a non-delegation clause when it comes to the authority to issue a mandatory 

recall? 

Dr. SUNDLOF. I am sorry, sir. Could you repeat the question? 

Mr. BUYER. Do you believe it is important to have a non-delegation clause when it comes to the authority to issue mandatory recall? 

Dr. SUNDLOF. OK. Thank you. Let me just say that in virtually 

every situation where we have asked for a recall, we have gotten 

compliance from the regulated industry. So it would be a very rare 

event if we asked for a voluntary recall and we were denied that 

recall. And in those extraordinary circumstances, I don’t have concerns that that delegation would be given to the Commissioner or 

even the Secretary because I believe these would be fairly extraordinary circumstances. 

Mr. BUYER. Why is it an important issue for you? 

Dr. SUNDLOF. Why is it an important issue? It is an important 

issue because we believe that there could be circumstances where 

the public’s health was at risk and where we were not given—our 

request for voluntary recall was denied and we would never want 

to find ourselves in that situation, where we couldn’t go out and 

ensure that we could remove any potentially risky food products 

from the marketplace. 

Mr. BUYER. Regarding your risk-based approach to, I don’t care 

whether the issues are in drugs or here in food, when you set forth 

the model or the paradigm to do that, there are acceptable levels 

of risk that you have to take. So when you articulate to us that you 

prefer risk-based approaches, can you elaborate a little bit further 

on why that is the preferable approach? 

Dr. SUNDLOF. It is the preferable approach because we want to 

make sure that with—the universe of food out there is obviously 

vast. We have limited resources and we want to use those resources as judiciously as we can to target those products that we 

believe have the greatest potential to cause harm to public health. 

So it is purely from the standpoint that we first of all want to have 

systems that we can identify what is a high-risk food, why is it 

high risk, and then make sure that we are paying adequate attention to those high-risk foods to ensure that they are safe and not 

ignoring the lower-risk products because we are finding that some 

of the products that we thought were low risk in the past actually 

turned out to be higher risk than we thought. We are really targeting our efforts to make sure that we are addressing the food 

that has the highest potential to cause harm to the public health. 

Mr. BUYER. When you come to judgment, do you have interagency cooperation or interdepartmental cooperation with the Department of Homeland Security? 

Dr. SUNDLOF. We do have frequent interactions with the Department of Homeland Security and we do discuss these issues. 

51 

Mr. BUYER. When you say ‘‘and we do discuss these issues,’’ so 

with regard to interfacing of targeting systems in your risk-based 

approach with regard to countries, localities, territories, companies 

that are on certain lists, is that what we are talking about? 

Dr. SUNDLOF. With Homeland Security, we have come up with a 

risk paradigm to identify which products have the greatest potential for causing a catastrophe should the food become adulterated 

intentionally, and I think Dr. Solomon has some more information 

on that. 

Dr. SOLOMON. The prior notice submission for food entries were 

located with Customs and Border Protection and Homeland Security at the National Targeting Center and our staffs along with 

USDA work side by side in looking at the assessment of entries 

coming in and particularly from a concern about bioterrorism concerns making those assessments jointly and sharing information so 

that co-location is very valuable to us. Other examples on Homeland Security relate to the pet food contamination, when we 

worked to stop product coming in from China, the wheat gluten 

and the rice protein concentrate, Customs and Border Protection 

and Homeland Security went out and did a nationwide blitz to see 

was there any evidence of this product, this contaminant coming in 

from any other country. So we focused on the initial product and 

Homeland Security focused on the rest of the border issues. 

Mr. BUYER. Thank you very much. 

Mr. PALLONE. Thank you. 

The gentlewoman from Wisconsin, Ms. Baldwin, for questions. 

Ms. BALDWIN. Thank you, Mr. Chairman. 

Dr. Sundlof, you have already addressed a couple of questions relating to the third-party system that is being proposed in this discussion draft to enhance and augment FDA’s food testing capabilities. As I understand it, FDA currently works with independent 

testers like Covance, who will be represented in the next panel. So 

I wonder, from your experience with independent testers, do you 

agree that they do sound, independent scientific testing, and also, 

can you speak to what sort of accreditation process you would envision FDA undertaking to ensure that the testing done by third parties is rigorous and in accordance with the highest scientific standards? 

Dr. SUNDLOF. Thank you. We currently do rely on independent 

third-party laboratories when, for instance, we have an import 

alert against a product coming into the United States. We require 

that those importing firms have their product tested upon entry to 

the United States and that they pay for that their through an independent third-party laboratory and then we review the results of 

that so we do have some good relationships. We do rely on them 

right now. In terms of accrediting, there are certain laboratory accreditation standards that I believe we would be relying on in officially accrediting. Right now we don’t accredit. We would like to accredit. We rely on the testing results of certain laboratories that we 

have confidence in but we want to take that to the next step and 

actually be able to accredit them. There would be—there are very 

good accreditation standards in place and we would most likely rely 

on what is already out there. 

52 

Ms. BALDWIN. What sort of accreditation processes are in place 

that you don’t currently use but you might? 

Dr. SUNDLOF. I think there are some ISO standards. I think 

there are other standards. I am not familiar with all of them right 

now. 

Ms. BALDWIN. The other question I have is, sort of trying to move 

FDA from basically being in a reaction mode for food safety issues 

and looking at what actions the FDA should be taking to prevent 

food contamination, food safety incidents before they even occur, 

and what could the FDA be doing right now to prevent future food 

safety threats? What additional authorities do you think the FDA 

needs to be more proactive and preventive, and what are your comments on the draft legislation’s provisions that seek to enable FDA 

to act more proactively by requiring foreign and domestic food facilities to have safety plans in place to identify and mitigate hazards? 

Dr. SUNDLOF. Thank you. What we asked for in our Food Protection Plan and Import Safety Action Plan is somewhat similar to 

what is in the proposed legislation. Under both of those plans, we 

would require two things. First, for intentional contamination, we 

would want our high-risk food areas to have certain preventive 

measures documented and in place that we could inspect against 

so that is a preventive measure. The other one that we asked for 

is for high-risk food production facilities, that they would have 

HACCP-like plans in place that we again could—mandatory—that 

we could inspect against to ensure that they were—that they did 

have effective preventative programs in place. 

Ms. BALDWIN. Thank you. 

Mr. PALLONE. The gentleman from Pennsylvania, Mr. Pitts, is 

recognized for questions. 

Mr. PITTS. Thank you, Mr. Chairman. 

Dr. Sundlof, do you think requiring the labeling of the country 

of origin of every ingredient in a product will improve the safety 

of that product, and if so, why? 

Dr. SUNDLOF. The safety of the products that come into the 

United States from other countries should be as safe as the domestically produced products. We are asking for these new authorities 

to help ensure that but I don’t want people to feel that relying on 

a country of origin label is going to give them information about 

the safety of that particular product. It should meet the United 

States’ standards. 

Mr. PITTS. And what is your primary concern about supporting 

the country of origin labeling? 

Dr. SUNDLOF. I don’t have—I don’t think I have a position on 

whether or not to support or not support country of origin labeling, 

only that it should not be viewed—if there is country of origin labeling, that it should be viewed as a way for consumers to make 

judgments on the safety of the product. We don’t believe that country of origin labeling in any way should be associated with the safety of foods imported from other countries. 

Mr. PITTS. What is it related to then? 

Dr. SUNDLOF. Well, it would be something other than that and 

again, we have not taken a position on anything else. From the 

point of view of the FDA, that is the thing that we are concerned 

53 

about the most is that food that is imported conform to the same 

standards as domestically produced food and therefore country of 

origin labeling does not provide any additional information. 

Mr. PITTS. Are you concerned about possible confusion with a requirement for labeling to the public and the concern about the difficulties of a manufacturer to comply and the cost for changing ingredients? For instance, if you have a product with 22 ingredients, 

and one of them is from Brazil, and, let’s say Brazil has a drought. 

The company may gave to go to Argentina for that particular ingredient. Are you concerned about the constantly changing label, the 

requirements? 

Dr. SUNDLOF. Again, since the FDA has not asked and the Administration has not asked for country of origin labeling, that is 

not something that we even consider at this point. 

Mr. PITTS. Do you think it would be a mistake if food safety legislation tried to undo what many food manufacturers have already 

put in place in regards to food safety and replace it with a system 

that relies on inspections of all facilities and testing of all food 

shipments? 

Dr. SUNDLOF. Certainly we don’t believe that inspection or sampling and testing of all food shipments is a feasible approach, considering that we receive somewhere on the order of almost 10 million import entries per year, at least at this time, not even feasible 

to try and test our way into safety. 

Mr. PITTS. If we are going to have the safest food supply system 

possible, don’t we have to rely or put more onus on the manufacturers to prevent food safety issues? 

Dr. SUNDLOF. Yes, absolutely, and that is one of the principles 

of both the Import Safety Action Plan and the Food Protection Plan 

is to put especially the prevention responsibility on the suppliers, 

manufacturers that are—— 

Mr. PITTS. Do most corporate food manufacturers have safety 

systems in place to prevent both intentional and unintentional food 

contamination? 

Dr. SUNDLOF. Many of them have excellent systems in place, not 

all of them. 

Mr. PITTS. Would you say most of them? 

Dr. SUNDLOF. I don’t have a figure on that. It becomes a matter 

of, you may have many, many small companies that produce a 

small percentage of the food versus large companies that produce 

a much larger—a few large companies that produce larger percentage but we are aware of many good plans already in place. 

Mr. PITTS. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Next is the gentleman from Utah, Mr. Matheson, recognized for 

questions. 

Mr. MATHESON. Well, thank you, Mr. Chairman. Mr. Chairman, 

I would like to work with you on another issue, which is not currently included in the discussion draft before us but I think it is 

an issue that is very much within the purview of the FDA and food 

safety and I think it should be included in legislation that we move 

here in the House. This is a problem that stems from the lead content of certain ceramic or decorative food ware such as plates. 

54 

In my home State of Utah, and I am sure in districts throughout 

the country, consumers are unaware that lead is component of 

glazes and can leach out of ceramic ware if the glaze is improperly 

fired or worn down from daily use. Children are at particular risk 

of lead exposure and this risk is compounded when we are talking 

about food containers because kids frequently consume acidic juices 

that leach lead from ceramics. Now, this issue recently hit home 

for me. A young mother in Utah who was breastfeeding her baby 

used ceramics plates to heat her food in the microwave. Her infant 

became very sick and ultimately her doctors discovered that the 

baby was suffering from lead poisoning because of the plates used 

in the food preparation for her mother. This mother was completely 

unaware of the potential health risk posed by certain ceramic ware 

products, as I suspect many, if not everyone in this room, as well 

would be aware of that risk. 

Mr. Chairman, I brought with me a brief video clip of news coverage which I think will give my colleagues on the Committee as 

well as our panel a better snapshot of this issue just as brief background. In November of 2007, over 400 people lined up at the Salt 

Lake Country Government Center to have bags and tubs filled with 

dishes along with toys and jewelry tested for lead levels. Once they 

found out that this is a problem, the public has responded with 

great concern. You will see lines of people in the video, which showcases the magnitude of interest in the problem. This runs for less 

than a minute but it helps highlight the story of this mother and 

her baby. Could we run the video? 

Mr. PALLONE. And I will mention the gentleman actually has an 

additional 3 minutes from what it is up there, because you had 8. 

[Video shown.] 

Mr. MATHESON. Well, as I said, I wanted to give a brief clip just 

to show how I found out about the issue and show how compelling 

it is when you see Chloe and her mom, who were subjected to this. 

Dr. Sundlof, what I wanted to ask you, first of all, I first want 

to just confirm, are you aware of the cases of lead poisoning among 

children that have been traced to ceramic dishes? 

Dr. SUNDLOF. No, sir. The last one that we are aware of in which 

ceramic ware was involved, and we don’t know if that was actually 

the cause of the increased blood lead levels in a child, was in 2004, 

and that was, I believe, in New York and there was a ceramic plate 

that was imported from France. That child did have elevated levels 

of lead in the blood but it is not clear as to whether the plate was 

the source or not. We do have standards. The FDA does have 

standards for lead in ceramic ware and we test at the borders for 

that. 

Mr. MATHESON. What percentage of plates coming in do you test? 

Dr. SUNDLOF. I will ask Dr. Solomon for input. 

Dr. SOLOMON. We actually do several different tests. One is a 

quick swab test, because the issue with lead—— 

Mr. MATHESON. Just how many do you test though? I guess that 

is what I am interested in. I mean, I can’t believe it is many of the 

plates coming in. Is it a small percentage that actually get tested? 

Dr. SOLOMON. We would have to get back to you for the record. 

Mr. MATHESON. I understand there is a Memorandum of Understanding that the FDA has signed with the state administration of 

55 

entry, exit, inspection and quarantine in China, and in that Memorandum of Understanding, you established a certification system 

that ceramic ware made in China that is imported to the United 

States would carry an inspection stamp. On the box it has a CCIB 

stamp for the Chinese organization. It also carries an FDA stamp. 

So when consumers go and buy these plates, and I have seen them 

in the stores in Utah, there is an FDA stamp on the box, but that 

stamp doesn’t necessarily provide any information to the consumer 

about lead content. What protections does that stamp indicate to 

consumers when they see the stamp on a ceramic plate that is 

being sold in the United States? 

Dr. SUNDLOF. This may not be the authoritative answer and I 

will get back to you if it is not, but what I believe that means is, 

we have assurances from the Chinese government that ceramic 

ware that is exported to the United States will meet our standards 

for lead. That doesn’t mean that they don’t have any lead in them 

but they will meet the low levels of leachable lead that we have established. 

Mr. MATHESON. See, what I think is, consumers, when they see 

an FDA label on a box, assume it is safe. That would be what I 

would assume. I think that is what most people would assume. And 

I think most consumers have no idea that lead exists in ceramic 

ware at all. Wouldn’t it be more useful at least to have a label on 

the box that mentions that this product may contain lead? I mean, 

I have got a plate right here. I can’t tell that it has lead but it has 

been tested. It has all kinds of lead in it. I have a plate right here 

that was sold by another company where they have stamped on it 

that it lead-free so you have some manufacturers that will tell you 

that they don’t have lead in their product but both of these that 

came from overseas are going to have that FDA label on the box 

and that doesn’t give me as a consumer much information at all. 

So it seems to me it might be helpful if we could maybe at least 

inform consumers that there is lead in the product. Would FDA be 

open to something like that? 

Dr. SUNDLOF. Well, the way that we—rather than declaring 

something to be lead-free, we have established levels at which we 

don’t believe that there is any harm to public health, that the levels of lead are extremely low that leach from these ceramic utensils. One of the other things that—what we are concerned about is 

the lead that can actually leach out of the plates. Many of the 

glazes do contain lead but if they are fired correctly in the process 

of manufacturing these plates, then that lead should be sealed 

there into the plate and not be available for ingestion. 

Mr. MATHESON. I am not here to argue about the level that is 

safe or not safe. I would suggest that in the testing that was done 

for hundreds of people in Utah, the levels were all over the map. 

Some of them were well in excess of FDA’s standards. And secondly, we don’t know if the glaze has been fired correctly, and as 

a consumer, I can’t tell you if the glaze is right on this plate. I have 

no idea if the glaze has been fired correctly. As a consumer, until 

I saw this story on the news back in Utah, I didn’t know there was 

lead in this. 

So Mr. Chairman, I am very anxious to see if there something 

we can do in this bill to make sure consumers are better informed 

56 

about the possibility of lead being in these plates so they can make 

their own decisions about using this type of plate to microwave 

food, and I appreciate you working with the Committee on this and 

I appreciate your indulgence with the extra time for questioning. 

I yield back my time. 

Mr. PALLONE. Thank you, and we will certainly follow up on your 

request. 

Next is the gentlewoman from North Carolina, Ms. Myrick for 

questions. 

Ms. MYRICK. Thank you, Mr. Chairman. 

I just have one question, Doctor. What would you say is the most 

cost-effective way in broad terms to improve food safety in this 

country without dramatically increasing the price of food, which is 

already very high right now and moving up? 

Dr. SUNDLOF. Well, if I look at all of the legislative authorities 

that we have requested in the Food Protection Plan and Import 

Safety Action Plan, I believe that third-party certification, where 

we can multiply our inspectorate by the use of independent third 

parties is the most effective way to improve the safety. 

Mr. PALLONE. Thank you. 

The gentlewoman from Oregon, Ms. Hooley, for questions. 

Ms. HOOLEY. Thank you, Mr. Chair. I have a question for Dr. 

Sundlof. Actually I have lots, but I am going to try to narrow this 

down. 

You mentioned in your testimony that FDA recently signed a 

Memorandum of Understanding concerning food safety and facility 

registration with China. Were you aware, and this may be happening in other States as well, that Oregon Department of Agriculture has been working for the last couple of years with China 

on food processing facility inspection protocols? What is your opinion of the role of States in food safety? 

Dr. SUNDLOF. I was not aware of that, and I don’t have a position 

on that. We can get back to you on that. 

Ms. HOOLEY. OK. That would be helpful. 

Several years ago, I was very involved in passing country of origin food labeling that actually made it through the House and the 

Senate and signed by the President and yet it has really never 

taken place. The question is, is that ever going to happen, number 

one. And number two, as we look at food processing and in talking 

to at least some of my food processors in my district, they were 

talking about, there are examples where they may get garlic that 

is a mixture of garlic from several companies that they put into 

whatever food they are making or they may have a bad year for 

broccoli one place and so you get it someplace else the next year. 

What do you think, and how do you do this if you are going to label 

that can or put it on a Web site? I mean, whose Web site, what 

do they have to list? Is it the final manufacturing where it is put 

in the can or put in the containers or whatever they put it in? Is 

that going to work, first of all? And will the public have more assurance that that will in fact make our food safer? 

Dr. SUNDLOF. Again, the FDA did not ask for country of origin 

labeling. I believe the U.S. Department of Agriculture does have 

that authority as well as the Treasury, I believe. We do not. We 

didn’t ask for it. As you indicated, there are complications in trying 

57 

to do that with the many ingredients that may make up a food and 

the fact that those sources of ingredients can change overnight. We 

certainly, as I said earlier, do not want or believe it is in the best 

interest of the public to be viewing country of origin labeling as a 

way of determining whether or not a product is safe because those 

products need to meet the U.S. safety standards just as domestically produced food. 

Ms. HOOLEY. Thank you very much. 

Mr. PALLONE. Thank you, and I think that concludes our questions. Thank you very much for your input, and in those cases 

where we asked for follow-up questions, if you could get back to us 

in writing as quickly as possible. Thank you again. Thank you 

both. 

Dr. SUNDLOF. Thank you, Mr. Chairman. 

Mr. PALLONE. And I would ask the next panel to come forward. 

I want to welcome our second panel, and let me introduce each of 

you. Starting on my left is Mr. Michael Taylor, who is research professor of health policy for the Department of Health Policy of the 

School of Public Health and Health Services of George Washington 

University. Next is Mr. Michael Ambrosio, who is vice president for 

food safety and quality assurance of the Wakefern Food Corporation in Elizabeth in my home State of New Jersey. And then we 

have Mr. James Lovett, who is a corporate senior vice president of 

Covance Laboratories. This says based in Princeton, New Jersey, 

but I know you mentioned—oh, OK. I know you mentioned Wisconsin as well. And then we have our colleague, the Honorable Cal 

Dooley, a former Congressman and president and CEO of the Grocery Manufacturers Association. Good to see you again, Cal. And 

finally is Ms. Caroline Smith DeWaal, who is the food safety director for the Center for Science in the Public Interest, who has been 

working on these issues for many years. Good to see you as well. 

As I mentioned, we have 5-minute opening statements from each 

of the witnesses. Those statements will be made part of the hearing 

record. Each witness may in the discretion of the Committee submit additional brief and pertinent statements in writing for inclusion in the record, and I will start again on my left with Mr. Michael Taylor, who is recognized for 5 minutes. Thank you. 

STATEMENT OF MICHAEL R. TAYLOR, RESEARCH PROFESSOR 

OF HEALTH POLICY, DEPARTMENT OF HEALTH POLICY, 

SCHOOL OF PUBLIC HEALTH AND HEALTH SERVICES, 

GEORGE WASHINGTON UNIVERSITY 

Mr. TAYLOR. Thank you very much, Mr. Chairman, Ranking 

Member Deal and members of the Committee. I appreciate the opportunity to testify today on the discussion draft of the Food and 

Drug Administration Globalization Act. Last year, as I think we 

have already heard this morning, the Government Accountability 

Office declared the Federal Government’s food safety program at 

high risk of failure due to its outdated laws, fragmented structure, 

and inefficient use of resources. This came after a decade of recommendations from GAO and the National Academy of Sciences to 

modernize the system legislative and organizationally so that it can 

be effective in preventing food safety problems instead of simply reacting to problems after the fact. 

58 

So Mr. Chairman, I applaud the subcommittee for tackling this 

critical issue and for focusing first on the obsolete food safety laws 

under which the Food and Drug Administration operates. FDA’s 

legal tools for addressing foodborne illness and the safety of imported foods were enacted in 1938. They may have been suitable 

for their time but they focus more on reacting to problems rather 

than preventing them and they are plainly inadequate to deal with 

today’s globalized food supply. 

As we embark on modernizing these laws, I urge the subcommittee to be clear first on the basic policy principles that should 

guide reform, and I think you will find good agreement among experts on the following five principles, and in fact, we have heard 

most of them embraced in varying ways already this morning. 

First, it is critically important to treat food safety as a farm-totable systemwide problem. This simply recognizes that hazards can 

be created and minimized at many points across the food system. 

Second, we must make prevention of food safety problems the central focus of the system because this is the only way to protect public health and maintain public confidence. Third, we must recognize 

that the primary duty for prevention falls on the food industry, as 

we have heard this morning. It is the industry, not government, 

that produces food, and only the industry can make it safe. Fourth, 

we must focus FDA on setting and enforcing standards that make 

the food industry accountable for prevention. Ensuring accountability by setting and enforcing standards is the unique and most 

essential government role on food safety. Fifth and finally, we must 

strengthen FDA’s mandate for providing national leadership and 

international leadership on food safety and bolster the agency’s 

tools for managing a science- and risk-based regulatory program. 

This includes a stronger research mandate and working with State 

and local governments to build a nationally integrated food safety 

system that makes good use of all its resources. 

Now, I think that the discussion draft that is on the table for discussion today embraces most of these principles to varying degrees. 

First and foremost, the discussion draft is, I believe, on the fundamentally right track in mandating safety plans and preventive 

controls for all food facilities, domestic and foreign. Importantly, it 

also recognizes in order for food safety plans and preventive controls to be effective in improving food safety and enhancing public 

confidence, the plans must be linked to food safety outcomes in the 

form of performance standards set and enforced by FDA. To me, 

this coupling of preventive controls with objective measures of performance is the most essential element of meaningful food safety 

reform. 

The discussion draft also addresses the important issue of food 

safety at the farm level with what I think is a very judicious approach to establishing standards for fresh produce and it includes 

some innovative ideas for enhancing oversight of imported foods. 

Overall, I think the discussion draft is the right starting point. 

As outlined in my written testimony, however, I do have questions about some provisions, such as the proposal for certification 

of food facilities. While I see its potential value for imports if done 

by credible third parties, I think we have to focus first on strengthening the accountability of importers themselves for ensuring the 

59 

*Mr. Taylor is Research Professor of Health Policy at The George Washington University 

School of Public Health and Health Services and chair of the Food Safety Research Consortium. 

He served formerly as Administrator of USDA’s Food Safety and Inspection Service (1994–96) 

and as Deputy Commissioner for Policy of the Food and Drug Administration (1991–94). 

safety of the food they import, and further, I do not think that FDA 

should be in the business of certifying food facilities. 

In moving forward with this legislation, I hope the subcommittee 

will also consider measures to strengthen food safety oversight at 

the retail level in collaboration with State and local agencies and 

to give FDA the research mandate and resources it needs to restore 

its scientific leadership on food safety. Mr. Chairman, restoring 

FDA’s capacity for leadership is critical to food safety and to public 

confidence in food safety. We need to get FDA’s food safety policies 

right and then we need to back them up with the resources to do 

the job. 

Thank you again for the opportunity to testify, and I look forward to questions. 

[The prepared statement of Mr. Taylor follows:] 

STATEMENT OF MICHAEL R. TAYLOR *

Mr. Chairman, Mr. Deal, members of the subcommittee, I appreciate this opportunity to testify on the food and cosmetic provisions of the Chairman’sFood and 

Drug Administration Globalization Act’’ discussion draft. 

INTRODUCTION

I applaud the subcommittee for tackling the modernization of our food safety laws. 

For over a decade, the Government Accountability Office (GAO) and expert committees of the National Academy of Sciences (NAS) have been documenting fundamental problems in the nation’s food safety system—a system that has evolved over 

many years without a coherent plan or strategy and that now includes some 20 components of FDA, USDA, EPA, and CDC, and 3,000 state and local agencies. 

Among all these agencies, FDA has long been looked to as the natural focal point 

for food safety leadership in the United States and internationally. It oversees 80% 

of the U.S. food supply (including an even greater share of imported food) and is 

the steward of a long tradition of effective, science-based regulation to protect public 

health. 

Unfortunately, FDA’s current ability to provide food safety leadership, or even 

meet its basic food safety responsibilities, is badly constrained by: 

• Obsolete statutes that date back to the 1930s and focus more on reacting to 

problems than preventing them; 

• Inadequate resources that are dwindling in the face of an increasingly complex, 

global food supply; and an 

• Internally fragmented and ineffectual organizational structure that makes FDA 

incapable today of providing effective food safety leadership. 

Certainly, FDA could be doing more with its present tools to address some of today’s pressing food safety problems. I believe, however, that FDA will continue to 

fall short of what the public needs and expects from this critical public health institution until Congress provides a modern statutory mandate, an adequate and stable 

resource base, and an institutional structure capable of national and international 

leadership on food safety. 

And that is why it is so timely and important for this subcommittee to be focusing 

on how to improve FDA’s food safety program. Getting food safety right at FDA is 

essential to the public’s health, to the confidence people want to have in the food 

they feed themselves and their families, and to the economic success of the food system. The subcommittee’s leadership will be essential to achieving these outcomes. 

In my testimony today, I will outline what I believe are the core policy elements 

of a successful strategy for improving food safety, and I will comment on how these 

elements are addressed in the discussion draft of the ‘‘Food and Drug Administration Globalization Act of 2008’’ released on April 18 by Chairman Dingell. I will also 

touch on the need to provide FDA an adequate and stable funding base for its food 

safety program and to unify and elevate the organizational elements of the program 

60 

so that FDA can once again provide food safety leadership, nationally and internationally. 

In general, I find the discussion draft to be very much on the right track. It recognizes that food safety is a farm-to-table and global challenge and that FDA’s program must be based not only on reacting to problems but on enforcing the duty of 

the food industry to prevent them. The draft legislation’s core requirement that companies have food safety plans—and that the plans be based on the concept of preventive process control and be designed to satisfy government-established performance standards—is central to any meaningful modernization of the food safety system. The draft also contains innovative provisions to address the safety of imported 

food. 

I will offer some suggestions for improving these and other provisions of the draft, 

and I will note some additional legislative needs I recommend the subcommittee 

consider. 

CORE POLICY ELEMENTS OF A SUCCESSFUL FOOD SAFETY STRATEGY

The following are the five core policy elements that I consider essential to a successful FDA food safety strategy. 

1. Treat food safety as a farm-to-table, system-wide problem. 

For most of the 20th century, food safety regulators focused largely on basic sanitation in processing plants, chemical contaminants in food, and the safety of chemical additives. It was possible then for FDA to focus on a relatively narrow set of 

establishments, commodities, and decision processes through which those concerns 

could be addressed. Over the last twenty years, however, the problem of foodborne 

illness caused by microbial pathogens has emerged as a central food safety concern 

and one that requires a broader, ‘‘farm-to-table’’ approach to ensuring food safety. 

A farm-to-table approach is required due to the simple reality that dangerous bacteria and other pathogens can enter the food chain at almost any point, from production on the farm through processing, retail sale, and final preparation for consumption; they can grow; and they can be killed. Thus, whether someone gets sick 

depends not on any one contamination event but on a wide range of events and behaviors that occur across the entire farm-to-table food system and that, in combination, determine the likelihood dangerous levels of an organism will be present at the 

point of consumption. 

This expanded understanding of food safety makes everyone—from farmers to 

consumers, as well as government food safety agencies—actors in the food safety 

system. It creates the opportunity and need for integrated action to minimize food 

safety risks at points all across the farm-to-table system—wherever pathogens can 

enter the food and grow or be reduced. FDA’s food safety program must recognize 

and act on this reality, as recommended repeatedly by GAO and NAS. 

This broader understanding of the food safety challenge—and the need to act in 

a comprehensive, integrated way to meet it—applies with full force to the growing 

volume of food imports. 

2. Make prevention of food safety problems the central focus of the system. 

Prevention is the core principle of public health and should be the central focus 

of the food safety system. Prevention of problems is certainly what consumers expect 

of the system, and it’s the core principle that drives modern approaches to food safety. Most notably, HACCP (Hazard Analysis and Critical Control Points) is a system 

of preventive process control that was developed originally by the food industry as 

a method for anticipating and preventing food safety hazards in particular food production and processing operations. 

FDA has adopted HACCP as a regulatory requirement for seafood and juice, but 

prevention is not an explicit part of its statutory mandate. In fact, FDA’s food safety 

legal authorities are designed primarily for reacting to and correcting problems after 

they occur, not for preventing them. In an on-going outbreak of foodborne illness, 

swift reaction and containment measures are important and can reduce the number 

of illnesses associated with that outbreak, but, to protect public health and meet 

public expectations for food safety, preventive measures such as HAACP need to be 

built in to the system so that the risk of food safety problems occurring in the first 

place is minimized to the greatest extent reasonably possible. 

FDA currently pursues prevention of this kind only on a selective and ad hoc 

basis. A comprehensive, systematic approach to prevention should be a core principle and central focus of the food safety system. 

3. Recognize that the primary duty for prevention falls on the food industry. 

This may be the most crucial point to emphasize in getting roles and relationships 

between government and industry right. The unavoidable reality is that government 

does not make food, and government cannot make it safe. That’s the food industry’s 

61 

job, and making food safe—doing everything reasonably possible to prevent food 

safety problems—is the most fundamental duty food producers and processors owe 

to America’s consumers. 

Many of our Nation’s leading food processors and retailers take this duty very seriously, and they make extensive efforts to fulfill it. They know food safety doesn’t 

just happen; it’s the result of a plan. So they impose safety specifications on their 

suppliers to be sure their raw materials and ingredients are safe, they implement 

HACCP and other preventive control measures within their processing plants, and 

they test their finished products to verify that their control systems are working. 

In fact, over the years, much of the food safety innovation in the United States has 

come from companies that take food safety seriously and have plans for achieving 

it. 

The problem is that many of the nation’s 44,000 food manufacturers and processors, 114,000 food retailers, and 935,000 restaurants do not have effective food 

safety plans. And, at the farm level, systematic planning for prevention of food safety problems is in its relative infancy. This must change. 

Any business involved in producing, processing, and marketing food must have a 

plan for making it safe, based on modern preventive controls. This does not mean 

a one-size-fits-all approach. It does not mean HACCP per se for every commercial 

participant in the food system. But it does mean that anyone producing food for today’s marketplace should know how they are going to make it safe and should do 

that consistently, every day. 

4. Focus FDA on setting and enforcing standards that make the food industry accountable for prevention.While the food industry is inherently responsible for making food safe by acting preventively, FDA’s job as a public health regulatory agency 

is to set and enforce standards that make the industry publicly accountable for prevention, in accordance with a defined standard of care. Setting standards for prevention means defining the responsibility of food producers, processors and retailers to 

have and implement food safety plans based on modern preventive controls. It also 

means establishing performance standards that define the level of protection, or 

food safety performance, that is to be achieved through preventive controls, such as 

the levels of chemical residues or microbial contaminants that are deemed acceptable. 

Standards protect food safety, however, only if companies comply with them, and 

it is FDA’s job to ensure compliance through inspection and enforcement. For many 

leading companies, compliance is not an issue: if the government sets a food safety 

standard, they will organize their systems to comply. In fact, many will go beyond 

what the government requires in response to the demands of their customers expressed in the marketplace. The food industry is, however, highly diverse, with some 

companies lacking the market incentive or an internal culture that ensures they 

meet high food safety standards. That’s why government standards and government 

enforcement are needed, and it’s why they are in the interest of both consumers and 

those in the industry who take their food safety job seriously and do it well. 

Government regulation of food safety is essential, but it has to be smart regulation. We have learned that old fashioned ‘‘command and control’’ regulation—in 

which the government specifies not only the outcome to be achieved but how industry must achieve it—can impose unnecessary costs and stifle innovation. Instead, 

modern regulation is clear in setting performance standards for companies and flexible in how companies can achieve the standard. Thus, as a regulatory tool, HAACP 

sets a standard of care for implementing preventive process control but is inherently 

flexible in allowing companies to tailor their preventive controls to the particular 

hazards and circumstances in their operations. Performance standards for microbial 

contamination say what level and incidence are acceptable, but they do not dictate 

the interventions needed to achieve them. 

In a food safety system based on holding the industry accountable for prevention, 

regulators have a duty not only to avoid stifling innovation but to affirmatively encourage it. This means among other things ensuring that regulatory review of new 

food safety technologies is done promptly and with an appreciation of the food safety 

benefits of technological innovation. 

5. Strengthen FDA’s mandate and tools for providing national leadership on food 

safety and managing a science- and risk-based regulatory program.While FDA’s core 

role on food safety is to set and enforce standards, it will be effective in this role 

only if it operates from a position of strength as the nation’s leading science-based, 

public health regulatory agency. To this end, FDA should have a clear mandate to 

drive research aimed at understanding food safety problems and solutions and setting science-based standards. It should work closely with CDC, other federal food 

safety agencies, and state and local agencies to build an integrated, national system 

of food safety protection. And it should provide scientific and policy leadership to 

62 

develop workable approaches to risk-based priority setting and resource allocation 

across the food safety system. 

COMMENTS ON THE DISCUSSION DRAFT

The five core policy elements outlined above reflect current thinking about the attributes of a modern, effective food safety system, as that thinking has evolved 

through the work of NAS, GAO and other experts. I will organize my major comments and suggestions concerning the discussion draft around these five elements. 

1. Treat food safety as a farm-to-table, system-wide problem. 

As I understand section 102 of the discussion draft, it would apply the requirements for a food safety plan and preventive controls to all facilities that process or 

store food for the U.S. market, whether domestic or foreign. It thus strengthens and 

modernizes standards for food safety in these critical facilities and recognizes, properly, that U.S. food safety standards should apply to imported food just as they do 

to domestically-produced food. 

The discussion draft also takes an important step in section 103 toward bringing 

agricultural producers more fully into the food safety system by making the food 

safety plan and preventive control requirements applicable to the production of 

fresh produce, subject to FDA being able to spell out how producers can comply for 

specific types of produce. I agree that, within FDA’s jurisdiction, produce deserves 

the highest priority in setting standards for on-farm prevention of food safety problems. I also agree that the measured approach taken in the discussion draft is appropriate, given the wide range of large- and small-scale growers involved and the 

relative inexperience of many in this sector with preventive process control. 

My only suggestion with regard to the produce provisions of the discussion draft 

is to include a clear directive to FDA to prioritize the types of produce that are most 

in need of preventive controls to ensure food safety and to move forward promptly 

with the needed regulations. In addition to produce, FDA has jurisdiction over onfarm food safety practices for eggs and has proposed regulations that would require 

preventive measures for egg safety. FDA should be directed to finalize those regulations. 

The subcommittee should also take note of the fact that animal production practices can be an important risk factor for produce safety, as well as the safety of meat 

and poultry products. In the case of produce, failure to prevent access of animals 

to fields where crops are grown or to manage manure in a way that prevents wateror air-borne transmission of pathogens increases the risk of contamination with E. 

coli O157:H7 and other dangerous bacteria. USDA and FDA both have roles to play 

in addressing animal production practices that affect food safety, but USDA has no 

authority to regulate on the farm for food safety purposes, and FDA’s mandate and 

authority in this area are at best murky. Congress thus needs to take a comprehensive look at how to improve the government’s ability, working in collaboration with 

the agricultural community, to strengthen food safety practices on the farm. 

While the discussion draft addresses the on-farm and processing segments of the 

farm-to-table spectrum, it does not address the critical retail sector, which includes 

both restaurants and grocery stores. State and local agencies play the frontline role 

in setting and enforcing standards at the retail level, and there is a long history 

of collaboration between these agencies and FDA, through the FDA’s Food Code and 

other efforts, to help ensure that state and local oversight reflects up-to-date science 

and is reasonably consistent nationally. This collaboration needs to be strengthened 

through training, technical assistance, and federal incentives for state and local 

agencies to adopt updated standards for retail food safety and implement them effectively. 

2. Make prevention of food safety problems the central focus of the system. 

The central strength of the discussion draft is that it would direct and empower 

FDA to implement a food safety system that is based on the public health principle 

of prevention. That is what the food safety plan and process control requirements 

in section 102 are all about, and I hope the subcommittee and Congress will adopt 

this essential reform. 

3. Recognize that the primary duty for prevention falls on the food industry. 

The discussion draft embraces the key principle that the primary duty for prevention rests with the food industry by requiring in section 102 that the operators of 

all facilities have food safety plans based on preventive controls. 

The draft also reflects the modern understanding of the key elements of preventive process control for food safety, which include hazard analysis, validation of the 

specific controls selected to address the hazards, monitoring and verification that 

the controls are working as intended, proper recordkeeping, and procedures for corVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00068 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
63 

recting problems when they do occur. It is important that, in codifying the food industry’s prevention duty, Congress spell out these basic principles. 

As section 102 recognizes, in-process and end-of-process testing can be important 

tools for verification that preventive controls are working properly. The nature of 

the company testing that is appropriate and useful for this purpose will vary substantially, however, based on the nature of the food and process involved. I believe 

the role of testing as a process control verification tool deserves serious discussion, 

with the goal of fostering such testing by companies when it can contribute to food 

safety, while preserving the flexibility for companies to adopt testing approaches 

that make sense in their particular operations. 

Section 107 calls specifically for end-of-process testing of food shipments to ensure 

compliance with applicable food safety standards, with the approach to testing depending on whether facilities are certified or not under the discussion draft’s certification provision in section 106. I interpret section 107 as being intended, at least 

in part, to provide incentives for facilities to seek and gain certification. I have some 

concerns and suggestions concerning the draft’s approach to certification, which I 

will note below. I see a need for discussion, however, of how section 107 testing relates to testing conducted under a food safety plan. Among other things, care needs 

to be take to ensure that the nation’s testing infrastructure is not swamped with 

testing—such as for baked bread, dry cereals, and low-acid canned foods—that may 

not contribute to food safety. 

4. Focus FDA on setting and enforcing standards that make the food industry accountable for prevention. 

From a public health and consumer protection perspective, food safety plans and 

preventive controls are valuable only to the extent they are designed and implemented to achieve acceptable food safety outcomes. Section 102 of the discussion 

draft adopts this principle in two critically important ways: (1) it explicitly directs 

FDA to examine food safety plans to ensure they meet ‘‘relevant regulatory and food 

safety standards,’’ and (2) it authorizes FDA to establish by regulation and to enforce performance standards that define for specific hazards the level of food safety 

performance a facility must meet. These are essential elements of the needed modernization of FDA’s food safety legal authority. 

I have one suggestion with regard to FDA’s role in setting standards. I recommend FDA be given an affirmative directive to identify the most significant hazards in the food supply, prioritize hazards with respect to the need for performance 

standards to prevent food safety problems, and to implement a program to systematically develop and adopt standards for the highest priority hazards. Without a 

mandate to set priorities and act preventively, the crisis-of-the-day reality in which 

FDA operates will keep it mired in reaction, rather than leading on prevention. 

While I think the discussion draft is basically sound in authorizing FDA to set 

standards, I have some concerns and suggestions about how the draft approaches 

FDA’s ability to hold companies accountable for meeting the standards. And standards benefit food safety only to the extent compliance is achieved. I’ll touch here on 

the basic enforcement mechanism for food safety plans, preventive controls, and performance standards; the role of civil penalties; and the proposed certification program. 

I see no enforcement provision in the discussion draft for the requirement that 

facilities have food safety plans based on preventive controls and that they meet 

hazard-specific performance standards. I assume this is a drafting oversight. I recommend that the legislation make it a prohibited act for a facility to fail to have 

a food safety plan that complies with the new requirement or to ship a product that 

fails to meet a hazard-specific performance standard. Products that fail to meet a 

hazard-specific standard should also be deemed adulterated. 

I support the availability of civil penalties as a tool for holding companies accountable for prevention. The prevention value of food safety plans and preventive controls depends on their being implemented successfully on a continuing, daily basis. 

This will happen only if a facility’s managers have in place not only a satisfactory 

written plan but the systems to ensure the plan is implemented properly. Many 

companies need no incentive from government to have such systems, but many do. 

For the shift to prevention to work in practice and be credible to the public, FDA 

needs accountability tools that provide incentives for these companies to work in 

this new way. 

Under current law, FDA’s most commonly used remedies for dealing with food 

safety problems are voluntary recalls and judicial seizure actions. In both cases, 

FDA is able to act only against the food itself, rather than the behavior that gave 

rise to the food safety problem. FDA can also seek court-ordered injunctions to control future behavior and criminal penalties to punish past conduct, but pursuing 

these remedies is extremely cumbersome and costly. 

64 

Civil penalties provide FDA an efficient remedy for situations in which companies 

have failed to act preventively by having and successfully implementing a proper 

food safety plan. A civil penalty provision should be crafted carefully to recognize 

that the implementation of a food safety plan is never perfect and that the success 

of a plan lies not in preventing every problem, but in minimizing problems as much 

as reasonably possible and responding well to contain problems when they do occur. 

I think the discussion draft’s approach to certification of food facilities in section 

106 deserves careful consideration and thought. I see the value of certification in 

the import situation as a way to bolster the assurance that products offered for import to the United States have been produced under conditions that meet U.S. 

standards. I think this can help compensate for the reality that the United States 

cannot possibly provide the same level of inspection and compliance oversight in foreign facilities that it can provide in U.S. facilities. I think it is even more fundamentally important, however, to clarify and strengthen the duty and accountability of 

U.S.-based importers for ensuring the food they import meets U.S. food safety standards. 

I also see the potential value of certification for domestic facilities as an element 

for FDA to consider in guiding the risk-based allocation of its inspectional resources, 

which I think is critical to the long-run effectiveness and efficiency of the federal 

food safety program. 

I have a number of specific concerns and suggestions about the certification proposal in the discussion draft, of which I will mention two here. 

First, certification should be done only by independent third parties, which, in the 

case of imports, could include foreign governments. I do not think FDA should be 

the certifying party. FDA should accredit certifiers, but not grant certifications 

itself. 

I base this view largely on my experience at USDA, where the granting of the 

government stamp of approval creates a commonality of interest between the agency 

and the company and erodes the independence and objectivity of the agency in assessing the company’s future problems and behavior. I’m also concerned that, if FDA 

is put in the certification business, that will become a dominant focus of the agency’s food safety managers, rather than setting and enforcing food safety standards. 

This is a particular concern because certifications are based on a snapshot in time, 

while the preventive approach to food safety depends on the continuing successful 

implementation of food safety plans and compliance with performance standards. 

Second, the discussion draft is not clear on how ‘‘compliance with applicable requirements’’ is to be determined for purposes of granting certification. Is it sufficient 

to have an adequate written plan? Does the plan’s successful implementation have 

to be demonstrated in practice over time? Does compliance with applicable performance standards have to be demonstrated? 

5. Strengthen FDA’s mandate and tools for providing national leadership on food 

safety and managing a science- and risk-based regulatory program. 

The discussion draft directs FDA to conduct research on testing methods, with a 

priority to be accorded development of methods to detect intentional contamination. 

This is good as far as it goes, but, as outlined earlier, I recommend that FDA be 

given a broader mandate to drive problem-solving food safety research; build a more 

integrated, national food safety system; and provide system-wide leadership for riskbased priority setting and resource allocation, as called for by GAO and NAS. 

RESOURCES AND STRUCTURE

Beyond a modernized statute, the other key ingredients for FDA’s future success 

on food safety are adequate and stable resources and a unified and elevated organizational structure. 

Provide FDA an Adequate and Stable Resource Base 

FDA’s resources for food safety have been eroding for years as the agency’s food 

safety challenge gets larger. Staffing levels are declining, and the total operating 

budget for FDA’s Center for Food Safety and Applied Nutrition—the resources available to take action after the staff and rent are paid—is down to around $25 million, 

which is a paltry sum for an organization charged with driving food safety progress 

across 80% of the American food supply, while also regulating dietary supplements 

and food labeling, ensuring the safety of infant formula and food additives, and attempting to provide food safety leadership internationally. An agency with all these 

responsibilities that can’t conduct or commission research, adequately equip its 

staff, or travel simply can’t do its job. 

FDA needs an adequate and stable resource base for its food safety program. The 

discussion draft addresses this need primarily through annual facility registration 

fees. This is, obviously, a controversial topic. I am one of many who believe that 

65 

public health and regulatory programs of the government should, ideally, be financed through normal appropriations rather than fees. The primary value at stake 

here, however, is that FDA must have an adequate and stable funding base. If appropriated funds are not realistically going to meet this need, registration fees are 

probably the least objectionable alternative, because they spread the cost widely and 

do not involve a direct quid pro quo between FDA and the industry. 

Unify and Elevate the Organizational Elements of the FDA Food Safety Program 

The third key ingredient for the success of any agency—after an appropriate statutory mandate and adequate resources—is an organizational framework suitable for 

its purpose. For food safety, FDA needs a framework that enables it to provide national leadership on food safety and run a coherent, well-planned program that 

makes the best use of available resources to improve food safety. For several reasons, FDA lacks such a framework. 

First, within FDA, the food program has historically taken a back seat to the drug 

and medical device programs in the competition for management attention and resources. This is due in part to the intense interest that drug and device companies, 

health professionals, and patients all have in FDA’s ‘‘gatekeeper’’ role for therapeutic products and is reflected in the fact that most FDA commissioners come from 

a biomedical or health care background. This strong tilt toward drugs and devices 

was exacerbated by the drug and device user fee laws, which have further focused 

FDA management attention, accountability, and resources on the therapeutic side 

of the agency. History has taught that the job of providing effective national leadership simultaneously on both therapeutic products and food safety is too big a job 

for any one person. 

Second, FDA’s organizational structure for food safety is fragmented and lacks a 

clear focal point for leadership. CFSAN ostensibly has the lead on food safety at 

FDA, but CFSAN actually shares food safety jurisdiction with the Center for Veterinary Medicine, which regulates pet food and animal drug and feed additive residues 

in human food, and with the Office of Regulatory Affairs, which manages the majority of FDA’s food safety resources through its field force of inspectors, compliance 

officers and laboratory personnel. The recent appointment in the Office of the Commissioner of an Associate Commissioner for Food Safety does not solve the problem. 

This position lacks budget or line authority for programs and thus in some ways 

further clouds responsibility and accountability for food safety within FDA. 

Finally, food safety leadership at FDA rests at least two bureaucratic layers removed from the Secretary of Health and Human Services. As decisionmaking in the 

executive branch continues to be centralized at higher and higher levels, with OMB 

having enormous influence on regulatory policy, the full time leader of the nation’s 

premier food safety program needs to have the greater clout in the system that 

comes from being presidentially appointed and reporting directly to the Secretary. 

I recognize that these organizational issues are beyond the scope of the discussion 

draft and that solving them requires careful thought and planning, but I hope that 

the subcommittee will see the need to tackle them as part of a continuing effort to 

equip FDA to do its food safety job. In my view, the solution lies in unifying the 

food-related components of FDA into a single organization and elevating that organization within HHS under the leadership of a presidentially appointed official reporting directly to the Secretary. 

CONCLUSION

Thank you again, Mr. Chairman, for the opportunity to testify on these important 

issues. I look forward to answering your questions and the questions of your colleagues on the Committee. And I would be happy to discuss with your staff further 

details on the discussion draft. 

MAJOR POINTS

•The discussion draft is on the fundamentally right track in mandating food safety plans and preventive process controls for all food facilities, domestic and foreign. •The establishment and enforcement of performance standards is a key element 

of prevention oriented reform, as contemplated by the discussion draft. •The process for setting and enforcing performance standards needs to be 

strengthened, including the judicious use of civil penalties as an incentive for compliance. •The application of the food safety plan and preventive controls requirement to 

fresh produce is a positive and important step toward a ‘‘farm-to-table’’ food safety 

system, but the legislation should also address improving oversight at the retail 

level. 

66 

• Certification can be useful to bolster confidence in imports and guide risk-based 

resource allocation of domestic inspection resources, but FDA should accredit certifying bodies, not grant certifications itself. •To ensure FDA’s success, Congress needs to address not only its legislative authority but also FDA’s resources and organizational structure. 

Mr. PALLONE. Thank you, Mr. Taylor. 

Mr. Ambrosio. 

STATEMENT OF MICHAEL AMBROSIO, VICE PRESIDENT OF 

FOOD SAFETY AND QUALITY ASSURANCE, WAKEFERN FOOD 

CORPORATION 

Mr. AMBROSIO. Chairman Pallone and members of the Health 

Subcommittee, I am honored to appear before you today to present 

our views and suggestions on the Food and Drug Administration 

Globalization Act and legislation. I am Mike Ambrosio, vice president of quality assurance, Wakefern Food Corporation, and have 

been in charge of food safety programs at Wakefern for the past 28 

years. 

Founded in 1946, Wakefern Food Corporation has grown from a 

small, struggling cooperative into a strong regional player with significant operations in the New York metro area. Headquartered in 

Keasbey, New Jersey, Wakefern, along with ShopRite stores, has 

become one of New Jersey’s largest employers with approximately 

32,000 associates in New Jersey and 47,000 overall. In 2007, retail sales totaled $10 billion. Wakefern operates 2.5 

million square feet of warehouses and logistical distribution centers 

supplying over 200 stores in New Jersey, New York, Pennsylvania, 

Delaware, Connecticut, Massachusetts, and Rhode Island. 

The Wakefern organization is the Nation’s largest retailer-owned 

non-farm cooperative in the United States and is comprised of 44 

members who independent own and operate supermarkets under 

the ShopRite banner. 

Mr. Chairman, I applaud you, your ranking member and the subcommittee for your efforts to improve food safety. We too believe 

that improvements will best be achieved through a three-tiered 

program that emphasizes prevention, intervention, and response. 

This morning I will present several of Wakefern’s recommendations 

for revising the bill, but I ask that my entire statement be included 

for the record. 

Media coverage of recent outbreaks, recalls, and food safety 

scares have contributed to a decline in consumer confidence and reveal new challenges for ensuring the food supply is safe in an everchanging marketplace. I am pleased to note that in 2008 with the 

Federal Government and the private sector working together to improve food safety, consumer confidence has rebounded. 

Our retail industry trade association, the Food Marketing Institute, working with Wakefern and its other members, has outlined 

a number of retail industry food safety efforts and goals in a report 

being released today. Mr. Chairman, I would like to submit this 

paper, the FMI Food Safety Paper: the Supermarket Perspective, 

for the record. 

Enhancing the safety of the food supply requires the active effort 

and strong support of suppliers, food wholesalers, and retailers, as 

well as government. This includes our commitment to train our 

67 

own people, our efforts to implement best food safety practices, and 

our outreach to consumers. It is a farm-to-table challenge that 

needs a farm-to-table solution. It is both a domestic and an international problem we must address together. 

Wakefern is committed to working with the supply community to 

constantly improve the safety of the food they manufacture, process, and to this end participate in the Safe Quality Food program, 

SQF. 

Within the domestic retail setting, training store managers and 

workers in food safety is an important tool. Currently Wakefern 

makes extensive use of the SuperSafeMark program. 

The final link is the supply chain is the consumer. Wakefern has 

long provided consumers with practical, science-based guidance on 

the safe food handling at home through the Partnership for Food 

Safety Education. Our customers expect the foods they purchase to 

be safe, whether it is store produced, manufactured, or farm grown. 

As retailers, we have an obligation to make sure we are sourcing 

from suppliers who have food safety plans in place. Accredited 

third-party certification companies are objective, independent bodies that are highly qualified to evaluate manufacturing facilities 

and to test, if warranted, that the supplier meets or exceeds all federally mandated food safety standards. 

One such program is SQF, which is managed by FMI and recognized by the Global Food Safety Initiative, which also recognizes 

several other certification programs. Wakefern uses SQF because 

SQF is a well-documented, validated food safety management system. We are pleased to see that your bill recognizes this concept 

but we would ask that you work with us to ensure that accredited 

third-party programs do not become a substitute for FDA inspection and regulation. These programs are best used to supplement 

and leverage FDA resources since FDA will never have sufficient 

resources to inspect every facility. In recognition of rigorous infrastructure currently in place, we encourage Congress and FDA to 

examine how other countries are using certification as part of the 

overall risk assessment plan. 

We believe that the FDA should be given the authority to mandate a recall in those cases where a company responsible for adulterated food does not act properly to recall a food. We also believe 

that suppliers should be required to give retailers immediate notification when a recall action is taken. 

In addition, there are several other initiatives we would like to 

support: global sourcing safety, rapid testing, safety standards for 

produce. Here again, as a retailer, Wakefern will be using SQF in 

a vigorous appeals process. There are several other food safety initiatives that Wakefern supports but were not included in your 

draft: traceback systems and designating a lead food safety agency. 

Mr. Chairman, there are also proposals in the legislation that 

Wakefern would not support and we have asked our industry trade 

association to examine more closely. These are registration fees, 

user fees, and country of origin labeling. 

Mr. Chairman, thank you for the opportunity to testify. I remain 

available to the subcommittee for further discussion and information should you need it. 

Mr. PALLONE. Thank you, Mr. Ambrosio. 

68 

Mr. Lovett. 

STATEMENT OF JAMES LOVETT, CORPORATE SENIOR VICE 

PRESIDENT, COVANCE LABORATORIES 

Mr. LOVETT. Thank you, Mr. Chairman and members of the subcommittee. I am James Lovett of Covance, one of the world’s largest and most comprehensive contract research organizations. 

Headquartered in Princeton, New Jersey, Covance has operations 

in more than 20 countries and more than 8,700 employees, twothirds of whom are in the United States. We conduct research and 

development for new medicines and provide laboratory testing services to food and other industries. One of my responsibilities at 

Covance is our food testing business. I thank you for inviting me 

to participate in this discussion on food safety. We strongly support 

the subcommittee’s efforts to advance food safety in our country 

and we also support the third-party testing provision in the draft 

discussion bill. 

Covance is a full-service laboratory to the food industry offering 

comprehensive testing services. Our facility in Madison, Wisconsin, 

is one of the largest food testing laboratories in the world. Our lab 

routinely analyzes more than 50,000 samples per month. It operates 24 hours a day, 7 days a week. It serves not just industry customers but also State and federal labs including the FDA. I would 

like to thank Congresswoman Baldwin for her support of our Madison facility, and she has actually toured our facility there, and I 

would also like to note that we operate food testing laboratories in 

Battle Creek, Michigan, and Singapore that have similar capabilities. 

Let me turn to the current status of food safety testing at the 

FDA. You know, the sheer volume, variety and complexity of FDAregulated imports coming into this country is stunning. FDA agrees 

in its Food Protection Plan that ‘‘increases in the volume and complexity of imported foods have taxed the limits of FDA’s approach 

to handling imports.’’ So FDA has recommended a new approach 

that includes the use of highly qualified third parties. 

We agree with the vision of the FDA and of this subcommittee 

about the potential contribution of third-party testing labs. This 

will provide several benefits. First is faster implementation. This 

country currently has significant private laboratory capacity capable of ramping up quickly to meet any new testing requirements 

desired by Congress and the FDA. Second is efficient use of limited 

resources, as we noted earlier. It is not necessary for FDA to dramatically increase its own laboratory testing capabilities. The capability exists already in the private sector, and we can quickly meet 

new requirements. Third is access to state-of-the-art testing facilities. Covance and many other qualified laboratories maintain highly trained staff and state-of-the-art equipment with a high level of 

automation, ensuring rapid and high-volume sample throughput. 

And then fourth is the ability of the FDA to maintain adequate 

oversight and control. FDA has worked effectively with Covance 

and other labs for many years on a variety of issues. Authorizing 

FDA to accredit third parties builds on the success but it should 

entail very strict accrediting requirements. 

69 

Let us face it. It is essential that the American public have a 

high level of confidence in their food safety and the testing of their 

food. Food testing laboratories, whether private or public, should be 

held to high standards. We have some suggestions for appropriate 

accreditation standards for consideration. 

First is FDA Good Laboratory Practices, or GLPs. FDA already 

has published GLPs for third-party laboratories for many years. We 

are not starting from scratch with third-party lab standards. FDA 

should continue to use this highly reliable standard which is respected across the globe. 

Second is the International Standards Organization, as was 

noted earlier, the ISO 17025 standard. ISO standards generally are 

used in manufacturing and the chemical and petroleum industries 

and in food processing and other areas. Requiring ISO certification, 

together with the FDA GLP program, would help ensure stringent 

recordkeeping requirements. 

Third is AOAC International official methods. The majority of 

testing methods actually used today for food testing have been fully 

validated and standardized by AOAC International. AOAC provides 

validation services for testing methods and AOAC official methods 

are considered the gold standard of test methods around the world. 

FDA laboratories themselves use an AOAC method when it is 

available, as does Covance. 

So in conclusion, Covance applauds the Committee for including 

provisions of its draft bill authorizing the FDA to accredit thirdparty labs. We believe there is an appropriate role for independent 

third parties to improve the safety of our food supply and this use 

of third parties will also permit FDA to quickly and easily alter resource requirements based on changing needs and circumstances. 

So I thank you for the opportunity to testify and I would be 

pleased to answer any questions. 

[The prepared statement of Mr. Lovett follows:] 

STATEMENT OF JAMES LOVETT

INTRODUCTION

Mr. Chairman and members of the subcommittee, I am James Lovett, Corporate 

Senior Vice President for Covance Inc., one of the world’s largest and most comprehensive contract research companies, with global operations in more than 20 

countries, and more than 8,700 employees worldwide (approximately two-thirds in 

the United States). Our company conducts research and development for pharmaceutical companies and provides laboratory testing services to the chemical, 

agrochemical, and food industries. I am responsible for Covance’s food testing business. We are pleased to have been invited as part of this discussion on food safety, 

and look forward to working with the Committee as this process continues. 

OVERVIEW OF COVANCE’S WORK

Covance is a full service laboratory to the food industry, offering comprehensive 

testing services for both food safety and food nutrition. The food testing organization 

originally grew from a research branch of the University of Wisconsin over 75 years 

ago. This testing facility in Madison, Wisconsin, is now one of the largest food testing laboratories in the world. The total Covance campus in Madison covers nearly 

one million square feet of laboratories and employs almost 2,000 scientists and technicians, and food testing is an important part of our operation. In addition to the 

Madison laboratory, Covance operates food testing laboratories in Battle Creek, 

Michigan, and in Singapore. 

The food testing laboratory in Madison can routinely analyze over 50,000 samples 

per month. It operates 24 hours a day, seven days a week. It provides rapid accurate 

70 

1FDA Food Protection Plan, Nov. 2007, p. 6. 

2 Id., p. 8. 

3 3 Id., p. 8. 

test data to industry customers, as well as state and federal government agencies. 

The food safety testing programs employed at Covance cover testing protocols for 

chemical contamination, microbiological contamination, pathogen detection, and detection of other deleterious contaminants. The testing profile includes detection of 

the contamination, identification of the chemical or microbe, quantification of the 

contamination, and confirmation of all positive test data. Our laboratories in Michigan and Singapore feature similar capabilities. Covance has provided food testing 

support to FDA for many years on a wide variety of projects. 

CURRENT STATUS OF FOOD SAFETY TESTING AT FDA 

FDA regulates roughly 80 percent of the U.S. food supply, which is $417 billion 

worth of domestic food and $49 billion in imported food annually. 1 FDA has oversight of more than 136,000 registered domestic food facilities. Approximately 

189,000 registered foreign facilities manufacture, process, pack, or hold food consumed by Americans. 

FDA plays a critically important role in ensuring the safety and public confidence 

in the food we eat. Foodborne illnesses are caused by more than 200 different 

foodborne pathogens of which we are currently aware. These include viruses, bacteria, parasites, and toxins, plus a vast number of potential chemical contaminants 

and metals. 

FDA’s Food Protection Plan outlines many of the factors complicating its mission 

of protecting the safety of the U.S. food supply. Changes in demographics, convenience trends, and consumption patterns are converging in a way that poses new 

challenges for ensuring the safety of the foods we eat. In addition, the sheer volume, 

variety, and complexity of the FDA-regulated products arriving at U.S. ports makes 

it nearly impossible for FDA to adequately oversee compliance with food safety 

standards and FDA regulations. According to FDA’s report, over 300 U.S. ports receive products from the more than 150 countries and territories with whom the U.S. 

trades. 2

FDA concedes in its plan that ‘‘increases in the volume and complexity of imported foods have taxed the limits of FDA’s approach to handling imports.’’ 3 In response, FDA has recommended a new approach for addressing potential safety 

issues with imported foods, including increased intervention in the form of targeted, 

risk-based inspections and testing. FDA’s plan supports the concept of accrediting 

highly qualified third parties to assist with this effort. FDA acknowledges it lacks 

the resources to adequately perform this function on its own. Furthermore, it understands that using qualified third parties will allow this new approach to be implemented more quickly and efficiently than by simply increasing FDA’s infrastructure 

and staff resources. 

Covance believes that FDA is doing the best it can with the resources it has. However, the reality is that less than 1 percent of U.S. food imports are tested. This 

does not compare favorably to the 25 percent that is tested in Canada or the even 

higher percent that is tested in Japan. We believe a risk-based plan, as suggested 

by the FDA, offers the best general approach to improving food safety without having to test every last article of imported food. However, even under a risk-based approach, our nation should clearly be testing much more food than it currently does. 

Even where good processes are believed to be in place to assure food safety, testing is the only way to be confident that those processes are actually working to 

produce and ship food that is safe for consumption by the American public. If you 

think about it, all food is tested—either in a laboratory before a human eats it or 

by the consumer at the actual time of consumption. We believe it is only prudent 

to have a robust testing program to ensure that the ultimate test—what happens 

when a human being eats the food—consistently results in a passing grade. 

BENEFITS OF A THIRD PARTY SYSTEM TO THE AMERICAN PUBLIC

Covance applauds the Committee for including within its draft bill a provision authorizing FDA to accredit third party laboratories. Authorizing FDA to accredit 

third parties to assist in the efforts to institute a more rigorous, risk-based approach 

to food safety testing will provide the following benefits: 

(1) Faster Implementation of New Food Safety Objectives 

(2) Efficient Use of Limited Government Resources 

(3) Access to State-of-the-Art Testing Facilities 

71 

(4) Ability of FDA to Maintain Adequate Oversight and Control 

(1) Faster Implementation—This country currently has significant private laboratory capacity capable of quickly ramping up to meet any new testing requirements 

desired by Congress or FDA. There is no need for FDA to do this alone—with longer 

timelines to ramp up and higher cost to the U.S. taxpayer—when capable private 

laboratories can help. 

(2) Efficient Use of Limited Resources—It’s not necessary for FDA to dramatically 

increase its laboratory testing capabilities. This capacity currently exists in the private sector and we would be able quickly meet any new testing requirements. 

(3) Access to State-of-the-Art Testing Facilities—Covance and many other highly 

qualified laboratories maintain ‘‘state of the art’’ equipment providing a high level 

of automation, ensuring very rapid and high volume sample through put. These sophisticated instruments provide the very highest level of sensitivity and selectivity, 

allowing our laboratories to provide extremely sensitive and precise test results. Our 

highly trained staff is able to report results faster than most other laboratories, including those currently operated by FDA. 

(4) Ability of FDA to Maintain Adequate Oversight and Control—FDA has worked 

with independent laboratories for many years in the human and animal drug approval process, the new cosmetic approval process, and in the submission of new 

food additives. In our experience, this process has worked well. Expanding some of 

the existing relationships by providing FDA with authority to accredit third parties 

to expand food testing capacity would rightfully entail very strict accrediting requirements. Only laboratories able to demonstrate the ability to comply with very 

strict standards established by FDA should receive accreditation. FDA should conduct compliance audits to ensure all accredited laboratories maintain these high 

standards. By placing control within the FDA for accreditation on the front end, 

while providing auditing authority to ensure third party laboratories maintain the 

required standards, FDA will have the tools it needs to maintain adequate oversight 

of this new authority. 

HOW A COMPREHENSIVE THIRD PARTY TESTING SYSTEM WOULD WORK

For a typical food shipment that FDA has determined must receive testing at a 

port-of-entry, we believe the process might work as follows: 

• When a food shipment arrives at a U.S. port, FDA or the importer would determine whether it should be subject to testing under FDA’s new risk-based testing requirements. If a shipment is chosen for testing, the food would be sampled according 

to a strict sampling plan determined by FDA to arrive at a ‘‘statistically’’ valid sample. These samples could be taken by third party, independent sampling companies, 

several of which already exist. 

• Samples would then be transferred to the third party laboratory—with the collected samples maintained under a ‘‘chain of custody’’ while they are transported. 

• Samples would arrive at the laboratory and be ‘‘logged in’’ to the laboratory data 

system. At the same time, FDA and the private food company would be notified of 

sample arrival and given an estimate for data completion. Within hours of sample 

receipt, the laboratory could initiate testing. 

• When test data is complete, results would be simultaneously transmitted to FDA 

and the food company. If any data show a presumptive positive for a pathogen or 

poisonous chemical, an investigation would be initiated immediately to confirm 

these results. Once again, notification would be sent simultaneously to FDA and the 

food company. 

•The testing company would conduct the investigation to confirm the test data 

and final reports would be issued to FDA and the food company. 

FDA ACCREDITATION AND OVERSIGHT OF THIRD PARTY LABS

It is essential that the American public have a high level of confidence in accredited third party laboratories. Therefore, I would like to expand upon the FDA accreditation requirements that will be critical to an effective and efficient third party 

testing program. 

The data produced by the independent laboratories will be used to make critical 

decisions about the quality of the U.S. food supply. Therefore, FDA must require 

rigorous standards and accreditation requirements for third party laboratories. We 

fully support the provisions in the draft FDA Globalization Act which provide for 

the Secretary to accredit laboratories, monitor laboratory performance and conduct 

annual audits. I will discuss some of the requirements we would expect FDA to include within its accreditation standards. FDA might include other requirements as 

well. 

72 

FDA GOOD LABORATORY PRACTICES

In order to become a qualified third party testing laboratory, FDA must provide 

for laboratory accreditation and certification, and the laboratory must be able to 

produce acceptable data in the proficiency testing program. FDA should standardize 

the test methods being used so that comparable procedures would be used by all 

testing facilities. FDA already has published Good Laboratory Practices (FDA GLP) 

for third party laboratories and this protocol has been followed by a multitude of 

laboratories in their data submission to FDA for many years. FDA should continue 

to use this highly reliable standard, which is respected across the globe. 

INTERNATIONAL STANDARDS ORGANIZATION (ISO) 17025 STANDARD

Another standard FDA might require as part of the accreditation process is ISO— 

the International Standards Organization—a European-based organization with a 

mission to standardize practices in a number of industries. ISO standards are used 

in manufacturing, in the chemical and petroleum industries, and in food processing. 

ISO’s published test methods are often similar to AOAC, which I will discuss in a 

moment. In particular, the ISO 17025 standard was developed for laboratories and 

requires comprehensive documentation of laboratory activities in the form of Standard Operation Procedures (SOP). The standard also requires a Quality Manual that 

describes overall business conduct. Companies are required to submit to an inspection for this accreditation, and must demonstrate acceptable testing performance in 

the form of an external sample evaluation program. Although not as comprehensive 

as the FDA GLP program, ISO 17025 is very effective in ensuring a laboratory 

keeps good records. Requiring ISO certification, together with the FDA GLP program, would be very effective in ensuring stringent recordkeeping requirements and 

the high standards for the measurement of the data quality. 

AOAC INTERNATIONAL OFFICIAL METHODS

The majority of the testing methods currently used today have been fully validated and standardized by AOAC International and these methods would provide 

a uniform framework for the industry. Founded in 1884, AOAC provides validation 

services for testing methods including laboratory evaluation, proficiency testing, and 

validation of test methods which are globally recognized. AOAC Official Methods are 

considered the ‘‘gold standard’’ of test methods around the world, and are recognized 

by regulatory agencies and courts of law. FDA laboratories themselves use an AOAC 

method when it is available, and these standards are already used extensively in 

the food and dietary supplement industries. This aligns the FDA and third party 

laboratories very well. We recommend FDA require use of AOAC methods whenever 

they are available. FDA might also be encouraged to establish priorities for development of additional AOAC methods to meet new testing needs as they are identified. 

SAMPLING PROTOCOL

The draft bill indicated that the sampling and testing for a non-certified food company will be handled by an accredited testing laboratory. Currently a number of different models exist for conducting sampling. In order to ensure the efficacy of the 

test results, it is important that the sampling protocol be uniform and clearly established. 

CONCLUSION

In conclusion, Covance applauds the Committee for including provisions in its 

draft bill authorizing FDA to accredit third party laboratories. We believe there is 

an appropriate role for independent third party laboratories in improving the safety 

of the U.S. food supply. Proper oversight by FDA will guard against any perceived 

conflicts of interest. Use of third parties will also permit FDA to more quickly and 

easily alter resource requirements based upon changing circumstances and needs. 

Other benefits as discussed above include the following: 

(1) Faster Implementation of New Food Safety Objectives 

(2) Efficient Use of Limited Resources 

(3) Access To State-of-the-Art Testing Facilities 

(4) Ability of FDA to Maintain Adequate Oversight and Control 

I hope my testimony will prove useful as the Committee considers measures to 

enhance FDA’s food safety testing capabilities. Thank you for the opportunity to testify and I would be pleased to answer any questions the Committee may have. 

73 

Mr. PALLONE. Thank you, Mr. Lovett. 

Congressman Dooley. 

STATEMENT OF CALVIN DOOLEY, PRESIDENT AND CEO, 

GROCERY MANUFACTURERS ASSOCIATION 

Mr. DOOLEY. Well, thank you, and I am delighted to be joining 

all of you today and I am testifying on behalf of the Grocery Manufacturers Association, the National Fisheries Institute, the Snack 

Food Association, the American Frozen Food Institute, and the 

American Bakers Association. We are all committed in representing our members to be partners with you and others to ensure that we can advance reforms that will enhance the safety of 

our food supply. 

In particular, as we move forward with considering what should 

be included in reforms, we have several measures. 

One, we urge you to give FDA the power to establish safety 

standards for fruits and vegetables. Two, we urge you to require 

that every food company has a food safety plan that is based upon 

food safety risk analysis, that documents appropriate food safety 

controls, and that is available for FDA to review. Three, we urge 

you to require every food importer to police their foreign suppliers 

and document for FDA review their food safety controls. And four, 

we urge you to give FDA new powers to address bad actors who 

have declined to recall contaminated food products posing a risk of 

severe health consequences. We are pleased that a bipartisan piece 

of legislation embodying these components was introduced just yesterday by Congressman Costa and Congressman Putnam. 

When we turn to the issue of the provisions that are in the discussion draft bill, we think there are many in there that are constructive but we do have some serious concerns about others. We 

have strong objections to the registration fees, the import fees, and 

other fees that will essentially result in $1 billion in taxes on food 

products which will show up in increased costs at the grocery store 

shelves. You put this on top of the energy legislation that was 

passed by this committee that is also diverting 25 percent of our 

corn crop from food to fuel, you are further compounding the rapid 

escalation in food prices that we have never seen in recent times. 

We are also very concerned about some of the prescriptive and 

regulatory approaches that would allow FDA inspectors to secondguess food safety decisions from many of our member companies 

that are really embodying the latest in technology and science to 

ensure that they have the most effective systems in place. What 

you would be effectively doing would be something that is analogous to asking the DMV inspector to be questioning whether or not 

the engineer that was designing the brakes for the Ford auto were 

the best. This is not the route that we should be doing down. 

And when we come to the issue of the third-party certification, 

I think we have to be very concerned about basically having FDA 

give the authority and the power of effectively a government agency to pass judgment on whether or not suppliers or manufacturers 

are in compliance with FDA regulations. Again, if you turn this 

around, what we are going to be effectively doing is saying to any 

producer of food or an ingredient product, regardless of where they 

are in the world, could be France, could be Canada, could be SomaVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00079 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
74 

lia, is that we are going to require them to be certified by a thirdparty entity that we have supposedly sanctioned to pass judgment 

on whether or not they are complying with our defined set of regulations and rules. What are we to expect is going to be the response 

to this? Do you not expect that Canada, that France, that the U.K., 

that China, that Japan will also put in place similar protocols that 

would require every exporter of a food product in this country to 

be accredited or certified by a group that they have sanctioned? I 

really ask the Committee to give serious consideration about going 

down a path that will inevitably invite a response that will have 

great harm on our ability to access international markets, which 

are so important to our industry. 

The food industry is willing, though, to accept that there are 

some needs for reform to ensure that we are allowing FDA to have 

the appropriate enforcement provisions when you have an instance 

of a need for a mandatory recall. You know, we support some of 

the provisions that include this for when you have a Class I need 

for a recall. 

The other provision I would like to touch on in closing is the provision that would allow for a $500,000 civil penalty to be assessed 

on a daily basis. Right now, what happens when you have a potential food safety problem that is occurring, is that there is a very 

collaborative interaction between the manufacturer and FDA and 

CDC, the Centers for Disease Control. If you put in place a threat 

of a $500,000 civil penalty, you are going to really undermine that 

collaboration, that discussion that really leads to the most efficient 

and quickest determination of what products pose a risk and getting them out of the market as quickly as possible. Our member 

companies do not need a threat of a civil penalty to ensure that 

they are deploying the best practices, and I would ask the Committee to give serious considerations whether or not that would in 

fact be an effective reform to enhance the safety of our food products. 

[The prepared statement of Mr. Dooley follows:] 

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Mr. PALLONE. Thank you. 

Ms. DeWaal. 

STATEMENT OF CAROLINE SMITH DEWAAL, FOOD SAFETY 

DIRECTOR, CENTER FOR SCIENCE IN THE PUBLIC INTEREST 

Ms. DEWAAL. Thank you so much, Chairman Pallone, and on behalf of our over 900,000 consumer members of the Center for 

Science in the Public Interest, I want to thank you for your leadership on food safety, and Representative Deal, Representative Barton, Representative Dingell, the many members of this committee 

who have worked long and hard on this issue in the last 2 years. 

The impact of foodborne disease has been fully described in hearings already before this subcommittee, and with this hearing I see 

that your committee is really starting the job of solving the problems in our food safety system. But let us not forget the victims, 

some of whom have testified before this committee, victims like 

Ashley Armstrong, who at 3 years of age suffered acute kidney failure and months of dialysis after eating E. coli-tainted spinach. Her 

cost, the costs of her family were unspeakable. Hundreds of thousands of dollars in medical costs. Her parents spent months in the 

hospital. Or Mora Marshall, who at 86 years of age was hospitalized and will spend the rest of her life in nursing care from eating 

salmonella-tainted peanut butter. As the Committee moves forward 

to consider this legislation, these are a few of the victims I hope 

you remember and the illnesses that we must prevent as you 

search for ways to empower the FDA with the resources and the 

authority that it so sorely lacks today. 

It seems like every week another food warning sends consumers 

to their pantries to look for the source of a melon or the production 

code on a recently recalled can or jar of food. Food outbreaks and 

recalls in recent years have caused a dramatic loss in consumer 

confidence and many, many costs to the food industry as well. 

CSPI has long advocated that Congress take this step of creating 

a modern food safety system, and we believe after analyzing 16 

years of outbreak data that this system we are operating under, 

and the proof is in the last few years, is fundamentally flawed. We 

need a new system. We have supported a unified food agency. We 

have brought forward many concepts and ideas to this committee 

and others but it is critically important that the new system be 

based on public health. 

While the FDA Globalization Act does not contain sweeping reform of the nature that we have proposed in the past, nonetheless, 

the improvements that it proposes are essential to address the gaps 

and weaknesses in FDA’s current food safety programs. It builds 

upon the improvements of the Bioterrorism Act of 2002 but adds 

a fundamental new structure to FDA’s food safety program. It contains numerous improvements. I will just mention a few: written 

process control plans utilizing performance standards that create a 

food safety foundation that has not before existed at FDA. It also 

contains a voluntary certification program for imported foods but 

one that has strong incentives to encourage food companies to seek 

certification and that is modeled on programs already in place in 

the retail sector and it also has important new enforcement auVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
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thorities, things like mandatory recall and civil penalties that the 

FDA needs to do its job. 

In the spirit of the draft discussion, CSPI has offered a number 

of suggestions, the most important of which is the recommendation 

that you increase the inspection frequency in the bill. The inspection frequencies you have right now of 2 years and 4 years are really not good enough and we would like to see those inspection frequencies increased to ensure that the food companies really know 

they have to comply. 

The FDA Globalization Act, though, really takes many ideas from 

many stakeholders, people like the Grocery Manufacturers of 

America, who put out their own plan; CSPI, who put out a white 

paper in the fall; and the Food and Drug Administration’s ‘‘Food 

Protection Plans.’’ It really very successfully weaves many of these 

ideas together. 

This hearing really demonstrates that there is widespread agreement among these entities and also the Committee here on the 

need to improve FDA’s oversight of imports, their inspection capability and their enforcement tools. While each stakeholder may differ on the particulars, the FDA Globalization Act offers an unprecedented opportunity for Congress to pass strong food safety legislation that in fact represents the best ideas for improving the current 

system. Thank you. 

[The prepared statement of Ms. DeWaal follows:] 

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Mr. PALLONE. Thank you, and I want to thank all the panel. We 

will start with questions and I will recognize myself initially for 5 

minutes. I am trying to get one question in for Mr. Taylor and then 

one for Mr. Ambrosio. 

Mr. Taylor, you mentioned the need to strengthen the performance standards section in the discussion draft. We have gotten 

some questions on this provision in particular as there appears to 

be confusion as to what performance standards are and what they 

should be. Some even feel that it would be impossible to create performance standards for all foods and would like us to focus only on 

the top 10 contaminants and those most risky products. In your 

professional opinion, what should we be aiming for as we expand 

the performance standards section of the bill? 

Mr. TAYLOR. I think this is a really important question to ask 

and I think Cal Dooley’s comments sort of pose the issue. I think 

I completely agree with Cal that what we are not talking about is 

standards where the government is going in and telling companies 

how to produce safe food and how to design the brakes in the car. 

That is the old-fashioned command and control approach to regulation, which is a failure. I ran the food safety agency as USDA 

which is based on that principle and I have seen it not working 

very well. When I use the term performance standards, I am referring to standards that address the outcome that is to be achieved. 

We have these in the current system today. We have pesticide tolerances, for example, that set a quantitative limit on the amount 

of a residue that can be present in food and companies then work 

to meet that outcome. They are not told how to do it. They work 

to achieve it. We also have standards with respect to microbial 

pathogens, which is what I think we are really focusing on here 

today and of course the recent work that FDA has done on Listeria 

trying to find a health-based level of Listeria that protects public 

health and that the companies can then work to meet that what 

I refer to as a food safety outcome that is an acceptable level of 

contamination so it is not about mandating how they do it, it is ensuring on behalf of the public that these food safety plans are actually designed to achieve an outcome that is acceptable to the public. The modern approach to regulation is performance standards, 

not command and control mandatory standards. 

I would also emphasize that there are many, many hazards in 

the food supply. I strongly believe that FDA ought to be directed 

to take a risk-based approach to focus on the most significant hazards in terms of impact on public health and figure out what are 

the selected commodity and pathogen-specific hazards for which a 

new performance standard can actually help drive progress on food 

safety so it should be targeted and it should be done in a way that 

is not prescribing how the industry does it but defines on behalf 

of the public what is an acceptable outcome in these high-priority 

cases. 

Mr. PALLONE. Thank you. 

Mr. Ambrosio, I would like to follow up on your comments on the 

concept of certification since your views on the matter seem to be 

different from Mr. Dooley’s. My understanding is that many retailers including most of the largest like Wakefern but also Wegman’s, 

Safeway, Giant, already now ask their suppliers to be certified for 

96 

safety by a third-party entity. In fact, that under one particular 

certification system already being used by major retailers, 30,000 

facilities were certified last year alone. Is it your sense that that 

is where the food industry is heading? Is it your view that certification can play an important role in helping to augment FDA oversight? 

Mr. AMBROSIO. Thank you. Certification can play an important 

and vital role in this. The SQF model, which is recognized by the 

Global Food Safety Initiative, is an international standard that 

parallels with the British Retail Consortium and the IFS. When 

you look at it, it is really, without getting too technical, and I can 

give you information with regard to the technicality of the program, but it truly is an enhanced HACCP program when you look 

at it. There are a lot of good things that manufacturers do, but in 

this particular case, when you look at a certification body that 

oversees what processes are being performed at those manufacturing facilities, it truly gives you a sense that there is a good management system that is put in place. It really is walking the walk 

and talking the talk. I mean, essentially when you go in there, it 

is the manufacturing facility that develops these plans and they 

live by it. It has been proven, it is worldwide, it has been globally 

recognized for several years now. It started when the Alar situation 

happened on the West Coast. So when you look at it from a global 

perspective, it is recognized. It parallels Dutch HACCP. It parallels 

many other global food safety initiatives that are out there and it 

is recognized. 

Mr. PALLONE. Well, you mentioned this particular one, the Safe 

Quality Food program. Do you want to just elaborate a little more 

on how that operates with you? 

Mr. AMBROSIO. Well, SQF is a FMI-managed program and essentially it is what I had said, it is a managed program. It is a really 

enhanced way of looking at things. They look at it from the grower’s level, if you want to look at produce, for that matter, and then 

they take it all the way to the processing end. There are different 

levels of SQF where you get into SQF 1000 and 2000 and both address the needs of what you are actually looking at. It is pretty 

much tailored to the specific discipline of the operation, so if you 

are looking at a manufacturer, there are disciplines within the 

body of that program that address that. If you are looking at a 

farmer, it gives you those disciplines with regards to the growing 

conditions, and if you are processing spinach, as we had the incident back in 2006, you will see that that will go right into the processing facility in which the spinach is manufactured. 

Mr. PALLONE. OK. Thanks a lot. 

Mr. Deal. 

Mr. DEAL. Thank you. 

Dr. Sundlof testified that he thought FDA should be given the 

authority to promulgate regulations to prevent intentional adulteration of food by terrorists or criminals. Do any of you oppose FDA 

being given that authority? I see no opposition. 

He also testified that FDA should have the authority to require 

that food facilities register with the FDA every 2 years. Do any of 

you oppose giving that authority statutorily? I see none. 

97 

He also testified that FDA cannot deny entry into the country of 

a food produced in a foreign facility where the facility operators 

hampered or denied FDA’s ability to inspect that facility. He asked 

that we change the law to allow FDA to deny entry of foods produced in that facility. Do any of you oppose us changing the law 

in that regard? Yes, Ms. DeWaal? 

Ms. DEWAAL. Mr. Deal, my apologies. Your second question slid 

by me. We actually support annual registration. 

Mr. DEAL. So the 2 years is not often enough? 

Ms. DEWAAL. Yes, but more to the point, all of these elements 

are—they are not opposed but they are not enough. They will not 

solve the problems we have seen with spinach, with peanut butter, 

with imported pet food and food ingredients. They will not solve 

those problems alone. But I don’t oppose them per se. 

Mr. DEAL. The foreign facility, I assume everybody would generally agree that if they have denied or hampered FDA’s authority 

to inspect, that we should at least give FDA the authority to deny 

products from those facilities coming in. Anybody opposed to that 

proposal? OK. 

He also requested in his testimony that FDA have the authority 

to order a mandatory recall in the event that a company does not 

conduct its own voluntary recall, and I think the indication is that 

we haven’t had that situation develop yet. Would any of you—and 

that that authority in FDA be non-delegable below the Commissioner of FDA level. Would you all generally support that proposition? I believe I see agreement on that. 

OK. Let me move to some of the other issues that we maybe 

don’t have quite as much agreement on. You know, I referenced 

PDUFA reauthorization in my opening statement, and when we 

have been dealing with user fees in the past, user fees have generally been considered to have benefit for the people who are paying the fees. In the case of pharmaceuticals, to speed up the process of the FDA review so presumably their product could get to 

market quicker. What benefit to the payor of these fees do you see 

in the proposal here? OK. Sort of what I thought. Let me ask you— 

oh, yes. OK. Yes, ma’am? 

Ms. DEWAAL. I think one of the issues of cost that has to be 

looked at is the price of not having a program, and not having a 

program today, an effective food safety program, actually costs consumers not to mention the cost to the victims of these outbreaks, 

which can be quite large, but even if you have a mild case of illness 

and you are out of work for 2 days, that costs you, your employer. 

So there are significant societal costs here. In addition though, the 

industry itself has faced significant costs from the failure and lack 

of a system. The spinach industry has faced, I think in liability 

costs alone, it is $100 million, which is what Mr. Dooley and I have 

been lobbying for as a minimum of what FDA needs next year to 

do its job for food safety. So the liability costs, the costs to the industry here are huge—business interruption, which occurred for 

the entire spinach industry. So the fee issues are not—nobody likes 

them but we need systems in place that are effective as soon as 

possible. 

Mr. DEAL. Well, I think all of us would agree that we would like 

to avoid these kind of bad situations developing. If any of us had 

98 

confidence that we could write a statute that would do that, certainly we would do it. I don’t think anybody thinks we have the 

ability to do that. 

Mr. Dooley? 

Mr. DOOLEY. Yes, if I can just respond, is that GMA and the related associations which I identified prior to my testimony, totally 

oppose the user fees that are currently being proposed or most of 

them that are being proposed in the draft. We would support perhaps a user fee that would be associated with an export certificate 

because that does provide a proprietary benefit. But again, when 

we look at this whole issue of public safety, this should be a public 

charge, much as your public safety on your streets and your communities of your neighborhoods, and that if you move down the 

path of charging a fee from the people who you are inspecting, you 

also have the potential to undermine the credibility and the integrity of this inspection service by having those who are being inspected basically funding it. 

Mr. DEAL. And as you know, that is one of the concerns that we 

have had of becoming so dependent on those fees for what is supposed to be an objective analysis. 

Thank you all, and my time is expired. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Deal. 

The gentlewoman from Wisconsin, Ms. Baldwin. 

Ms. BALDWIN. Thank you, Mr. Chairman. I have been focusing 

a lot in opening statements and previous questioning on the discussion draft’s third-party testing provision. I am going to continue to 

do that with just a couple of quick questions for Mr. Lovett. 

The discussion draft contemplates additional food testing over 

what is currently occurring, and I am wondering, looking forward 

to ultimate passage of a bill, implementation of a bill, what proportion of additional testing would you see third-party laboratories 

taking on versus FDA itself? 

Mr. LOVETT. Thank you for your question, Congresswoman Baldwin. I think that third-party labs can take on substantial testing. 

It is not that there are a lot of empty labs sitting out there, just 

ready to start running tomorrow because obviously, our free enterprise system doesn’t work that way. But companies like ourselves 

can ramp up laboratories very quickly. Just last year the Singapore 

laboratory that I mentioned, we took an empty building and 6 

months later had an ISO 17025 certified laboratory running testing 

on food, and so, this is ramp-up that can happen very quickly and 

I think that in the absence of very substantial appropriations to 

allow the FDA to build the large number of labs that I think will 

ultimately be needed, the private sector can really make a big contribution here. 

Ms. BALDWIN. You mentioned in your testimony that currently 

your company, Covance, works with the FDA, government at the 

federal level, State level, and private entities. Can you talk a little 

bit about the current partnership you have with FDA and then also 

explain to me how would the testing done by your company or a 

third party compare to the type of testing that is currently done by 

the FDA? Is it similar or is it different? Please elaborate. 

99 

Mr. LOVETT. Yes. Thank you again. I will take the second question first, if you don’t mind. I think the testing is actually quite 

similar. You know, we both run AOAC methods when that is feasible or when they are available, and we run similar methods on 

other occasions. So I think the testing between a good government 

lab and a good private lab is basically the same. 

In terms of work we have done with the FDA, it has been myriad 

work over the years on a multiple of occasions. Often it is something where, for example, in the case of ephedra, when that first 

became a safety concern several years ago, there wasn’t a good 

method to identify ephedra in food and it was actually Covance 

that was retained by the FDA to develop a liquid crystal mass 

spectrometer analysis—I am a lawyer, not a chemist—to identify 

ephedra in both supplements and food. These were then fully validated by the AOAC and the FDA and they were used together with 

data that we generated through our own testing to ultimately ban 

dietary supplements containing ephedra. Another example is acrylamide. When that became a concern, we were contracted by the 

FDA to conduct a large market basket survey to identify how much 

acrylamide there actually was in a whole series of different kinds 

of foods, and I think that is a good example where we were able 

to ramp up very quickly to do what was a very large volume of 

testing on short notice that would have been difficult for an existing government lab that is already very busy to take on. 

Ms. BALDWIN. Thank you. 

Mr. LOVETT. Thank you. 

Mr. PALLONE. The gentleman from Pennsylvania, Mr. Pitts. 

Mr. PITTS. Thank you, Mr. Chairman. 

Mr. Dooley or anyone else who would like to respond, given all 

the new requirements, the import choke points, testing of every 

single import, what could we expect to happen to the price of food 

if this bill passes? 

Mr. DOOLEY. Well, inevitably there would be an increase in the 

cost or the price of production that would inevitably be passed on 

to consumers so you would see an increase, but it is hard to quantify just what the magnitude of that would be. We can quantify 

what the magnitude of the fees would be. I mean, you have in the 

legislation with the registration fees, that is $600 million. If you 

look at the $10,000 per importer fee, what does that mean to Mr. 

Ambrosio’s stores that he has. If they are importing directly, maybe 

it is wine from France or cheese from Europe or someplace, are 

they going to be liable for a $10,000 fee, or that little boutique 

store that you might have on Main Street that is an importer directly, are they also going to be $10,000? We look at that as being 

another magnitude that could be as much as $400 million on top 

of that. And then if you go into the regulatory side of it, that inevitably is going to increase some prices. But the one thing I want to 

clarify is, is that there is a lot of our companies today are doing— 

have in place the best practices, and when it comes to the audit, 

what we are concerned with is, we have a proposal that would say 

that every private sector company that has a set of preventive controls in place and if you are importing you have a supplier quality 

assurance plan, that plan will inevitably include a third-party 

probably certification or audit. But that is going to be a private 

100 

contractual arrangement that they will have with their supplier. 

Why we are so concerned and what we think will add additional 

costs here, if you have FDA sanctioning one audit that might be 

out there, is that you can create a restriction in the marketplace 

which will drive up the costs of audits that will also be passed on 

to that consumer, and you also have the threat of again imposing 

these on other countries and their companies that are manufacturing that they are going to have a new cost there that they are 

going to respond. And so I think we have to be very careful about 

going down this path of this certifying these third-party auditors. 

Mr. PITTS. Now, you mentioned ethanol, the ethanol mandate for 

gasoline has dramatically increased the cost of food. Can we estimate the increase in the cost of food for this bill in conjunction 

with the ethanol mandate? 

Mr. DOOLEY. You know, we haven’t done the complete analysis 

on that. We have currently retained an economist that is doing 

some modeling to get some more precise figures in terms of the increased cost of food that is associated with the ethanol mandate. 

On this provision we haven’t done that work yet. 

Mr. PITTS. Can you provide the Committee with the analysis 

when you—— 

Mr. DOOLEY. We will do that. 

Mr. PITTS. Thank you. 

The draft calls for labeling packaged meat and poultry products 

when it has been packaged using minute levels of carbon monoxide. 

The rationale is that it may artificially keep the meat red longer 

and mislead consumers. Are there types of packaging that have the 

effect of preserving the redness of meat longer? 

Mr. DOOLEY. Yes, there are a number of different alternatives 

that processors can use that can provide for preserving the color as 

well as in preserving the quality of the product for an extended period of time and this is an example. When I mentioned in my testimony that we are very concerned about prescriptive controls being 

put in place, this is a classic example of Congress putting a prescriptive control on what type of technology can be used in the 

packaging of a meat product. They are requiring a separate label 

that will basically make this very difficult to be used in the marketplace, and the concern that we have is that you have—when I 

was serving in Congress, of the 435 colleagues that I had there, 

none of them I think had a Ph.D. in food science, and yet you have 

Congress promulgating a provision that will impede the adoption 

and utilization of technology that has benefits to consumers. 

Mr. PITTS. Has there been any evidence that the use of carbon 

monoxide in meat packaging has any adverse health effects? 

Mr. DOOLEY. The scientific evidence overwhelmingly points out 

that this poses no health risk to consumers by its utilization. 

Mr. PITTS. OK. I just have one more question. The draft requires 

country of origin labeling for where the final product was produced 

along with a requirement to maintain a Web site with a list of all 

sourced ingredients. Can you comment on that provision in terms 

of your ability to do it and in terms of what it contributes to food 

safety, anyone? Go ahead, Mr. Dooley. 

Mr. DOOLEY. Well, first off, what the grocery manufacturers are 

absolutely committed to, it doesn’t matter if that food product that 

101 

you are manufacturing in the United States or if you are importing 

a food product or if you are importing ingredients from any country 

throughout the world that those have to be safe, and that this idea 

that we are going to be able to develop a Web site where we can 

put on every ingredient that is in a particular product, it is going 

to be problematic. I mean, you look at a pound of Folgers coffee on 

the grocery store shelf. It could have beans coming from 27 different countries. And if you look in the frozen food aisle, you might 

have a product that has mixed vegetables in it. Well, at different 

times of the year, that company is going to be sourcing those vegetables from different countries. So are we then to put on the Web 

site this product could contain vegetables that came from these 50 

countries at some point during the year, and what is the value to 

the consumer by providing that information? We would say there 

is little to none and it will not provide any significant benefits in 

terms of—any benefit whatsoever in terms of food safety issues. 

Mr. PITTS. Thank you, Mr. Chairman. 

Mr. PALLONE. I am going to go to a second round, in part because 

I think we expect Mr. Dingell to come back so I am going to ask 

some questions myself and then we will go back and forth again 

for those who would like to. 

Going back to Congressman Dooley again, in your testimony you 

emphasize that we need to implement a risk-based approach for 

the prevention of contamination, and in our conversations with industry experts, oftentimes though they sort of indicate that that is 

not an easy thing to do. Can you elaborate on this idea and explain 

how it would factor in safety mechanisms for what usually would 

be considered low-risk products like peanut butter which, as you 

know, was a recent cause of a salmonella outbreak? 

Mr. DOOLEY. Well, I think that—and Mr. Taylor probably can 

elaborate on this too, is that there are some products that are processed in a manner which they are inherently low risk. There are 

some products that are going to be more acidic that are going to 

be a lower risk. There are going to be some products which are 

fresh and are semi-processed that are going to be of higher risk, 

and we need to have a regulatory system and an inspection system 

that is developed where you are allocating more of your scarce resources if you are FDA on those products that pose the greatest 

risk. And I would even say when you look at the fee structure that 

you put in place, does it make any sense to charge a flat fee of 

$2,000 across the board or should that be a risk-based fee? Does 

it make any sense to have an arbitrary number of inspections saying a plant has to be inspected every 2 years regardless of the risk 

of that product that is being processed? Once again, you need to 

have a system which is identifying the inherent risk of a product 

to consumers to have a foodborne illness and then allocating your 

resources in a way that is going to make the biggest difference. 

Mr. PALLONE. I still don’t understand how you would propose to 

do this risk-based modeling. I mean, I have been having a problem 

with that in many areas, not just this one, but let me go back 

to—— 

Mr. DOOLEY. If I can respond? 

Mr. PALLONE. Sure. 

102 

Mr. DOOLEY. What you are doing in effect if you are establishing 

some of the performance standards that Mr. Taylor referenced, you 

are in fact then identifying that there are some levels in some 

products that are going to need to have a performance standard because you have identified a risk. This is not that hard to do. 

Mr. PALLONE. All right. Following up then, let me ask Ms. 

DeWaal because obviously this relates to both what Congressman 

Dooley and Mr. Taylor said, I mean, you heard Mr. Taylor’s views 

on the performance standards and basically this is the same question. What would we look at in terms of performance standards, 

and given the difficulty, in my opinion, in structuring a risk-based 

model, how do you factor this all in? 

Ms. DEWAAL. Thank you, Chairman Pallone. On this issue of 

risk-based whether it is performance standards or inspection frequency, one thing that we have seen over the last year is even the 

U.S. Department of Agriculture, which has a much more robust inspection system, has been unable to develop the data necessary to 

really catalog their facilities in terms of risk. It doesn’t mean they 

are not going to continue to work on it but the bottom line is, they 

don’t have that system in place today to do it. In terms of performance standards, the way the Globalization Act is structured right 

now allows for FDA to utilize performance standards where they 

see it is appropriate. It leaves discretion in the agency itself to use 

performance standards. The model of using performance standards 

to evaluate and measure how the process controls are working is 

an excellent model but again, I would agree with your assessment—we are not there yet. We can’t use it for every single food 

product, but we can use it more effectively than we do today. 

Mr. PALLONE. Mr. Taylor? 

Mr. TAYLOR. I just might add a point to hopefully clarify and add 

to this. The provision in the bill that would call for standards for 

fresh produce is an example, I would argue, of taking a risk-based 

approach, taking the evidence that we got from the outbreak investigations that have shown that we do have a risk of contamination 

of fresh produce with certain bacteria and that there is a need to 

put in place standards to prevent that, and the standards would 

presumably be crafted scientifically to address a particular hazard, 

whether it is salmonella or E. coli, and be a way to measure the 

success of the efforts that were taken, so the risk-based approach 

is making the decision to focus efforts in terms of standard setting 

and then inspection on this particular set of commodities because 

they pose public health risks. I want to underscore, there was some 

suggestion that somehow the food industry in running its business 

would take a risk-based approach. Well, in a way that is true, but 

the food industry has a fundamental obligation which I think most 

companies take seriously to ensure that every food that they 

produce is safe. You can make any food unsafe if you allow contamination with pesticides or other chemicals and so there is that 

foundational duty that the companies have to be sure that the 

broad standards for safety in the food laws are met, but the riskbased approach is really focused on how we target government efforts to get a public health benefit for the resources that are invested. 

Mr. PALLONE. Mr. Pitts, do you want to ask any more questions? 

103 

Mr. PITTS. I will ask another one. 

Mr. PALLONE. You are recognized. 

Mr. PITTS. Thank you, Mr. Chairman. 

To anyone, according to the FDA Food Protection Plan, there are 

over 300 ports in the United States where food is imported into 

this country. The draft legislation would require a certification for 

food facilities or the importer would be limited to the ports in 

which there is an FDA lab in that metropolitan area. Given that 

some labs are not located at major ports, the number of ports 

where food could be imported could actually be lower than 13. Is 

it practical to say that we are going to have the number of ports 

available to import food to be less than 13, and not have a devastating effect on our food supply? Who would like to comment? 

Ms. DeWaal. 

Ms. DEWAAL. Thank you so much. In terms of narrowing the 

number of ports of entry from 300 to 13, I think that the intention 

of the bill is not the way I read it plainly is to have a system where 

it is voluntary to get certified but there is a strong incentive. If 

companies want to continue to operate exactly as they do today, 

which is they can go to any port of entry they choose, they get certified, and it gives a time frame for allowing that certification to 

occur. It can’t occur overnight because there aren’t probably enough 

certifiers in place. The thing that certainly hit home for me as I 

listened to the FDA witness today was the fact that today they are 

not using their laboratories for the most part to check imported 

food. Very little imported food today is ever checked in a laboratory. I believe it is like two-tenths of 1 percent. So the new system 

will have to utilize laboratories, whether they are FDA laboratories 

or private laboratories, to do the testing that is needed for imports 

and that is not being done today. 

Mr. PITTS. Anyone else like to comment? 

Mr. Taylor. 

Mr. TAYLOR. Well, I think the certification issue is getting a lot 

of discussion before this legislation moves forward. I think it is a 

very interesting idea and I think it has significant questions 

around it. I would urge that we think about certification as an addon, a way to supplement a system that is based fundamentally on 

the duty of the importer to be able to document how it was that 

food they are importing, they are importing into the United States, 

they should be able to document how it is that that food was produced in a way that meets U.S. standards. As I understand the 

proposal that the GMA put out last fall on imports, that is what 

they recommend, and the reason I think that is so important because that is the legally accountable entity here in the United 

States that FDA can hold responsible and can prevent their ability 

to bring imports into whatever port if that assurance is not provided. Then there is the question of how those companies meet 

that—those importers, I should say, meet those duties and I think 

there are roles for third-party certification and a lot of different 

ways to sort of provide that assurance but I would build certification on top of a foundation of accountability for the importer to 

provide assurance that the product produced overseas is being produced in accordance with the same standards that we are able to 

enforce directly here in the United States. 

104 

Mr. PITTS. Mr. Ambrosio? 

Mr. AMBROSIO. We like testing, as retailers. However, that is not 

what I really look at from my standpoint governing where I have 

to govern. Testing only validates a process. I don’t know how many 

items you would have to test in order for somebody to feel good 

about it. If you look at Salinas Valley and you look at lettuce in 

that valley over there, and I have been there several times, how 

many heads of lettuce do you have to test in order for somebody 

to feel good about it? It all goes back to the culture of those farmers 

and how they produce the item and how they harvest the item coming to port. So you can test and test and test but you might not 

see everything that you are testing. Testing only gives you a snapshot and it validates the program. In the case of the biggest outbreak we have ever had on produce, it was domestic, it wasn’t imported. So I think we really have to look at what we are doing domestically first and then think about we can take the good practices that we have learned domestically and then give the importers more of an opportunity to enhance their growing manufacturing 

procedures. 

Mr. PITTS. Mr. Lovett? 

Mr. LOVETT. If I could just build on what Mr. Ambrosio said, I 

totally agree that testing only validates an existing program and 

it is really the overall program that assures food safety. At the 

same time, that just begs the question of how much testing is needed to really validate the program, and I am not sure that twotenths of 1 percent is enough. So I think even to go to 1 percent 

would be a fivefold increase, which would be very substantial. 

Without delving into all the details of certification as it relates to 

the question you first raised about linking ports of entry to the 

FDA labs, I think that leveraging the resources of private labs, 

which I think is going to be needed as a practical matter to increase the amount of testing at a rate that we are all going to probably want to see, means that you don’t necessarily have to have 

that linkage to a particular port because there are private labs in 

all kinds of locations. 

Mr. PITTS. Thank you very much for your testimony. My time is 

up. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Again, I am just going to ask a few more questions. We are waiting for Mr. Dingell. He should be here any minute. 

Let me go back to Mr. Dooley again. In your testimony, you 

state, and I quote, ‘‘Congress should direct FDA to develop a plan 

to help build the scientific and regulatory capacity of major exporters to the United States.’’ Do you want to develop that? I mean, 

I know you made that statement, but what do you expect to be 

done to follow up on that? 

Mr. DOOLEY. Well, I think this is where you really have to define 

that public-private partnership that can really help develop the capacity in many of the developing countries of the world to have the 

ability not only to establish the appropriate standards and protocols but also the ability to enforce those, and that is where I think, 

the potential. I don’t want anyone to think that I am a critic of a 

standard for an audit. I think, though, those audits ought to be a 

105 

private contractual arrangement between the retailer, the manufacturer, and potentially the companies that are providing those ingredients. So there is the ability to help build out a private sector 

infrastructure that could see the greater utilization of some of 

these audits that have higher standards that can be deployed, and 

in some instances could be sanctioned by those governments to become the standard for that particular country. So there is a lot of 

work here. I mean, we are all part—the CSPI and GMA and others 

are part of a coalition to increase the funding for FDA. You know, 

we want to double it over 5 years. We think there are opportunities 

to do it. We are not talking about that much money in the grand 

scheme of things and we want to be a partner with all of you in 

trying to achieve that. 

Mr. PALLONE. Thank you. 

Mr. Dingell, Chairman Dingell is recognized for questions. 

Mr. DINGELL. Mr. Chairman, thank you. 

I would like to welcome my old friend, Mr. Dooley, back and tell 

him how pleased we are to have him here. Just real quickly, Mr. 

Dooley, do you think our current system of regulation is working 

well? Yes or no. 

Mr. DOOLEY. Being a former Member of Congress, it is difficult 

to say yes or no. 

Mr. DINGELL. Well, I only have 5 minutes and I have lost 15 seconds of it already. 

Mr. DOOLEY. I think the system is working as well as we should 

expect. You know, we need to modernize FDA. 

Mr. DINGELL. I note here that we have had 76 million illnesses, 

325,000 hospitalizations, 5,000 deaths annually due to foodborne 

illnesses. Does that tell you things are working well? 

Mr. DOOLEY. You know, we would clearly state that there is 

room for improvement. We are committed to trying to implement 

the private sector reforms and the public reforms that can achieve 

that, and we also have to accept what are the sources of those 

foodborne illnesses. 

Mr. DINGELL. Let us look at this now, Mr. Dooley, because you 

are one of our experts on this matter. As I understand it, when the 

food processing industry spends money, they then charge it back 

against the consumers, for example, when they buy produce, they 

charge that against the consumers. When they advertise the buildings and food processing machines, they charge that against the 

consumers. When they have wages and things of that kind, they 

charge that against the consumers, right? 

Mr. DOOLEY. We operate in a manner that is similar to any other 

private sector business, be it the auto industry or the food industry. 

Mr. DINGELL. So you are here complaining, I note, about the fact 

that the food processing industry is going to be paying a $2,000 annual tax for each food facility and a $10,000 annual tax for each 

food importer to finance food objectives. That is a major objection 

of yours, is it not? But that is something that you are going to level 

against the consumers, isn’t it? That is not being extracted from 

your pocket. That is coming out of the pocket of the consumers, 

isn’t it? 

Mr. DOOLEY. It is a cost of doing business. 

106 

Mr. DINGELL. Cost of doing business, and you are going to happily assess that against the consuming public. So if the consuming 

public doesn’t complain about that and the consuming public says 

this is a good idea, we are going to get safer food, your complaint 

is pretty much vanished because, lo and behold, the people who are 

going to have to pay the charge happen to like the idea and your 

folks aren’t going to pay it. Now, what, given that circumstance, is 

your complaint? 

Mr. DOOLEY. I would say that I don’t subscribe to your assessment that the consumer would have no problem with their food 

costs being increased, and I also would note that the Consumer 

Federation of America also objects to user fees. 

Mr. DINGELL. Let us look at this thing. Your folks are afflicted 

by trial lawyers, who start lawsuits against your folks because you 

sell unsafe commodities and they collect big judgments, don’t they? 

Mr. DOOLEY. Our folks are totally committed to producing the 

safest products. 

Mr. DINGELL. But the trial lawyers extract large sums of money 

in most generous settlements paid for by your clients, don’t they? 

Mr. DOOLEY. On the rare instance where we do have a food safety problem, trial lawyers oftentimes do find profit opportunities. 

Mr. DINGELL. And your folks sit there in this very unhappy situation where you are seeing all this stuff coming in from China, dog 

food that is doctored, catfish, and other fishery products that are 

coming in that are coming from some of the most contaminated, 

polluted waters in the world. They are full of bacteria and microbes 

and all manner of nasty things, viruses, and as we look at it, the 

Chinese lace these very heavily with antibiotics. Now, I am not 

sure who they are protecting, the Chinese or us, but our people are 

getting a lot of antibiotics. Do you like that situation? 

Mr. DOOLEY. No, and we are pleased that the legislation that—— 

Mr. DINGELL. And your people are—— 

Mr. DOOLEY [continuing]. Congressmen Costa and Putnam have 

introduced will put in place—— 

Mr. DINGELL. Let me finish. 

Mr. DOOLEY [continuing]. Standards that improve that. 

Mr. DINGELL. Your people are selling this stuff to Americans. 

Your members are doing that. And frankly, I have the view that 

you need a little protection from that situation, don’t you? 

Mr. DOOLEY. That is why we have advanced a set of proposals 

that would enhance the level of food safety. 

Mr. DINGELL. So you need Food and Drug to have the money, the 

personnel to check these matters out, do you not? 

Mr. DOOLEY. That is why we are part of the Alliance for a 

Stronger FDA. 

Mr. DINGELL. Yes or no is usually quite sufficient because my 

time is, regrettably, very limited and I want to hear from you but 

I have to hear the answers that I need to hear so we have a good 

record, so we understand what you are really standing for and 

what you are really telling us. 

Now, I was just taking a look here and I found that after the 

spinach outbreak in 2006, this comes from testimony which you 

may have heard already, spinach farmers reported losing $350 million, and have still not recovered when a second leafy green outVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00112 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
107 

break occurred in August 2007. Big lawsuits, spinach market 

killed, your people inconvenienced, lawsuits filed, fine mess, right? 

Mr. DOOLEY. But we have supported FDA being required to develop good agricultural practices for leafy greens and other 

produce. 

Mr. DINGELL. OK. So then we find that Peter Pan, and I like 

their peanut butter, but all of a sudden they had an outbreak that 

cost ConAgra $140 million, including $55 million in lost sales. That 

has gone on forever. Now, it occurs to me that maybe if Food and 

Drug had a little better capacity to inspect these things, we could 

all feel a little bit safer. These things might not have occurred and 

all the other things that are happening with regard to foods and 

pharmaceuticals wouldn’t be transpiring. Am I right? 

Mr. DOOLEY. No. 

Mr. DINGELL. Now, I am kind of surprised to hear you say that 

you do not believe that a stronger food safety system would provide 

service to your industry. 

Mr. DOOLEY. No, what I was saying, if I can go beyond the no, is that ConAgra, as you stated, they realize when they have $140 

million loss with this one outbreak—— 

Mr. DINGELL. Well, do you think—— 

Mr. DOOLEY. —what more incentive do they need to have to put 

in place—— 

Mr. DINGELL. Let me ask—— 

Mr. DOOLEY. —protocols to make sure that won’t happen. 

Mr. DINGELL. Let me ask a question here. Do you think that we 

need a stronger food safety system in service to your industry or 

not? 

Mr. DOOLEY. Yes. 

Mr. DINGELL. Yes, you do agree? OK. Now, because you are goodhearted folks, make a fine living by putting food on Americans’ dinner tables and the result of a good Food and Drug is that your people are protected, they don’t get all these nasty lawsuits, they don’t 

lose sales, they maintain customer confidence and a guy comes in 

and says well, I still want to get Peter Pan peanut butter because 

I think it is safe, but they lost $55 million on this deal and the 

spinach people are still not recovered. Now, what we have proposed 

in the discussion draft are fees. Fees are designed to improve the 

safety of the Nation’s food supply and also to assure that you folks 

in your industry get safe foods in from places like China where 

they sell all manner of crap to the citizens of China, unsafe stuff, 

and if you have been to China, as I have a number of times, I think 

you have too, you will find that you are going to be damn careful 

of what you eat over there or you are going to come down with 

something real nasty, and what we want to do is see that this stuff 

that comes in is safe. I hope you are supportive of that. Are you? 

Mr. DOOLEY. Well, you are supporting—enhancing the food safety system. That is recognized by the work—— 

Mr. DINGELL. The thing I find most interesting, Mr. Dooley, is, 

almost every other Food and Drug-regulated industry—pharmaceuticals, medical devices, animal drugs—they have all come forward and said this is a good idea, we want to have strong Food and 

Drug to protect our people against unsafe commodities, and yet 

comes my old friend Cal Dooley says we don’t need any help, everyVerDate Nov 24 2008 15:21 Oct 07, 2010 Jkt 037690 PO 00000 Frm 00113 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-108 SCOM1 PsN: JIMC
108 

thing is fine while we are poisoning people with bad fish from 

China, while we are poisoning people with unsafe spinach and peanut butter that is causing huge outbreaks of gastric difficulty to 

our people. Don’t you think that is a little backward approach? 

Mr. DOOLEY. I think that was a—— 

Mr. DINGELL. The food industry has had years of wonderful exemption from regulation. They just don’t bother you. They get 

around to see your folks about every 10 years, look at the plant and 

say well, maybe this plant is OK, but the other 9 years and threequarters, there is nobody bothering you. And look at what has happened. People are getting sick, bad commodities are getting on the 

market, and my old friend Cal Dooley is coming in here and telling 

us that this industry does not need any help. You are protecting 

the American people. 

Mr. DOOLEY. Mr. Dingell—— 

Mr. DINGELL. I think we can take a poll in this room today and 

see how many people agree with you, or if we would walk up and 

down the street and ask Americans how good a job you are doing, 

I suspect they wouldn’t be in agreement with you. What do you 

think about that? 

Mr. DOOLEY. Will you give me the courtesy of responding? 

Mr. DINGELL. I find myself curious. You have never been able to 

produce the support that it takes in your industry to give Food and 

Drug the resources that it needs. Nobody else has. So finally we 

have a way of making Food and Drug be able to finance things of 

particular importance. Now, it is interesting to note on imports, 

less than 1 percent of the imports of food are inspected by Food and 

Drug. You have unsafe fish, you have unsafe vegetables, you have 

unsafe meats, you have all kinds of stuff coming in. You have unsafe pharmaceuticals coming in. You have counterfeits. You have 

adulterated, filthy foods, pharmaceuticals and things of that kind 

coming in from overseas and here comes my old friend Cal Dooley 

here to tell this poor Polish lawyer from Detroit we really don’t 

need any help, we are doing just fine. How do you feel about that? 

Mr. DOOLEY. The industry and GMA back in September of last 

year advanced our four pillars for enhanced food safety. The basics 

and the components of those proposals is embodied in legislation 

that has been introduced by Congressman Costa and Congressman 

Putnam yesterday. It is a clear demonstration of this industry’s 

commitment to enhance our food safety and further define the public-private partnership which can achieve those outcomes. We also 

make it very clear that, much like the medical device and the pharmaceutical industry, we will support user fees that provide a proprietary benefit to our members. 

Mr. DINGELL. Let us address this. Since this industry all of a 

sudden became energized by the talk of introduction of legislation, 

they began doing all these things and yet unsafe foods are coming 

in from China. People are still getting sick from unsafe foods. Food 

and Drug doesn’t have the resources to do the job and you are here 

this morning, or this afternoon now, telling us that you don’t need 

any help and everything is fine. 

Mr. DOOLEY. Mr. Dingell, that is a clear misrepresentation of my 

statements. We have consistently stated that we are supportive of, 

and have been constructively engaged with, your staff, with Mr. 

109 

Pallone’s staff, with Republicans and Democratic members of this 

committee in offering our ideas and proposals on how we can enhance the food safety, both domestic as well as international. 

Mr. DINGELL. Mr. Dooley, I have the greatest fondness for you, 

as you well know, but I didn’t roll off the cabbage wagon yesterday, 

and I happen to know that your industry will go to any length to 

avoid legitimate regulation to protect the consumers. We are going 

to do that with your help, and I hope we will have your help, and 

we are going to do it without your help if we don’t have your help. 

I will tell you, it will much easier for you and the industry to work 

with us than to work against us. I hope you will cooperate with us 

because the facts, Mr. Dooley, are not with you. 

Mr. Chairman, I thank you. 

Mr. PALLONE. Thank you, Chairman Dingell. 

Mr. Pitts, did you want to add anything? You are done? All right. 

First of all, let me thank all the members of the panel. We really 

appreciate your time and your bearing with us, and as Mr. Dingell 

said, we really do want your help and your cooperation and your 

ideas as we move forward, so thank you again. 

Let me just say in closing, I want to remind the members that 

they may submit additional questions for the record to be answered 

by the relevant witnesses. The questions should be submitted to 

this committee clerk within the next 10 days so you will find out 

within the next 10 days if there are additional questions that we 

would like to have responses from in writing. 

Without objection, this meeting of the subcommittee is adjourned. 

[Whereupon, at 1:17 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

STATEMENT OF HON. HENRY A. WAXMAN

I want to thank Chairman Pallone for holding this very important hearing today. 

I also want to commend our colleagues, Chairman Dingell, Chairman Pallone and 

Chairman Stupak for their efforts in pulling together this very strong legislation to 

address the very serious and glaring gaps in FDA’s authority. 

There are few issues that matter more to Americans than the safety of the foods 

they eat and the drugs and devices they rely upon each day to keep them healthy— 

or to save their lives. 

People want to have the very basic assurance that, when they sit down for a meal, 

the food they eat won’t make them sick. That should just be a given in our country. 

Americans expect no less. 

Unfortunately, we now have far too much evidence that FDA has not been meeting these expectations. 

Tainted peanut butter, contaminated fresh produce, uninspected imports about 

which little is known. I could continue with this list, but I think we have become 

all too familiar with it. Sadly, Americans have practically become accustomed to 

hearing these stories in the newspapers and on the nightly news. 

So it is critical that we get FDA the authorities and resources it needs to fix this 

very disturbing and dangerous situation. 

This bill takes some significant steps in that direction. 

I strongly support the inclusion of a mandatory facility registration along with 

corresponding registration fees. The fees are minimal—just $2,000 per year per facility. This is a common-sense way to get FDA a desperately needed infusion of resources. 

We are asking FDA to take on a great deal of new responsibility here and each 

aspect of that responsibility demands resources if we want FDA to succeed. The registration fees will provide a critical portion of those dollars and I hope the food industry will get behind them. We all know that giving FDA authority without the 

necessary resources is tantamount to doing nothing at all. 

110 

I also want to briefly address the third party certification program in the bill. As 

many of you know I’ve long been opposed to the concept of permitting third parties 

to fulfill what are essential FDA functions. But in the area of foods, where there 

are over 300,000 facilities around the world, I understand we are looking at a very 

different situation from the drug or device context. 

So I think that there is a case for considering the use of third parties to supplement FDA’s oversight of the imported food supply and to enlist the states in helping 

us inspect the domestic food supply. But this third party system is far from an ideal 

system for protecting American consumers, and a far cry from having FDA itself 

doing this work. 

So if we create this kind of system, we have got to proceed with great caution. 

Ensuring that basic safeguards are in place is absolutely critical. 

FDA must be able to maintain careful controls over the use of these third parties. 

FDA’s accreditation process needs to ensure that the certifying agents possess the 

skills, expertise, and training necessary to act as an effective FDA surrogate. The 

Agency should be required to issue regulations clearly setting forth who may or may 

not become accredited. Once a third party is certified, FDA needs to perform frequent spot checks of certifying agent’s work to ensure that those third parties are 

fulfilling their responsibilities—and then have the flexibility to swiftly revoke an accreditation if FDA concludes failures have occurred. 

It is also critical that there be no conflicts of interest between the certifying agent 

and the facility. 

I look forward to working with Chairman Dingell, Pallone, and Stupak to make 

sure these protections are clear and effective. If this program does not have integrity, it will not succeed. 

We will need FDA to be our partner in bringing about the change envisioned in 

this legislation. We need strong leadership from the FDA and from the Administration both in the legislative process and after this bill becomes law. 

As we continue the drafting process, we need and expect the Administration’s cooperation in giving us full and open access to FDA’s expertise and knowledge. 

We also must have the best estimates from the Administration for the resources 

that are necessary to permit FDA to do the job we are asking it to do in this billand to do it well. 

The time to act is now. I feel confident we have the political will here in Congress 

to get this done-and soon. The American people are counting on us. 

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