AMERICAN LIVES STILL AT RISK: WHEN WILL 

FDA’S FOOD PROTECTION PLAN BE FULLY 

FUNDED AND IMPLEMENTED? 

HEARING 

BEFORE THE

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INVESTIGATIONS 

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COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

JUNE 12, 2008 

Serial No. 110–126 

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AMERICAN LIVES STILL AT RISK: WHEN WILL FDA’S FOOD PROTECTION PLAN BE 

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AMERICAN LIVES STILL AT RISK: WHEN WILL 

FDA’S FOOD PROTECTION PLAN BE FULLY 

FUNDED AND IMPLEMENTED? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

JUNE 12, 2008 

Serial No. 110–126 

( 

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, . R., 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 . EGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff 

GREGG A. ROTHSCHILD, Chief Counsel 

SHARON E. DAVIS, Chief Clerk 

DAVID L. CAVICKE, Minority Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan, Chairman 

DIANA DeGETTE, Colorado 

CHARLIE MELANCON, Louisiana 

Vice Chairman 

HENRY A. WAXMAN, California 

GENE GREEN, Texas 

MIKE DOYLE, Pennsylvania 

JAN SCHAKOWSKY, Illinois 

JAY INSLEE, Washington 

JOHN D. DINGELL, Michigan (ex officio) 

ED WHITFIELD, Kentucky 

Ranking Member 

GREG WALDEN, Oregon 

MIKE FERGUSON, New Jersey 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

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

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

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

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

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 6 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

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

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 8 

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

Tennessee, opening statement ............................................................................ 10 

Hon. Mike Doyle, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 11 

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

Texas, opening statement .................................................................................... 12 

Hon. Jan Schakowsky, a Representative in Congress from the State of Illinois, opening statement ....................................................................................... 14 

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

prepared statement .............................................................................................. 108 

WITNESSES

Lisa Shames, Director, Food and Agriculture Issues, U.S. Government Accountability Office ................................................................................................ 15 

Prepared statement .......................................................................................... 18 

Gail H. Cassell, Ph.D., Vice President, Scientific Affairs and Distinguished 

Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company ......... 35 

Prepared statement .......................................................................................... 36 

J. Glenn Morris, Jr., M.D., M.P.H., T.M., Director, Emerging Pathogens Institute, University of Florida ................................................................................... 38 

Prepared statement .......................................................................................... 40 

Michael R. Taylor, J.D., Research Professor of Health Policy, The George 

Washington University, School of Public Health and Health Services ........... 42 

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

Jeffrey Levi, Ph.D., Executive Director, Trust for America’s Health .................. 50 

Prepared statement .......................................................................................... 52 

David W.K. Acheson, M.D., Assistant Commissioner for Food Protection, Food 

and Drug Administration, Department of Health and Human Services ......... 68 

Prepared statement .......................................................................................... 71 

SUBMITTED MATERIAL

Letter of June 11, 2008, from Minority to Messrs. Obey and Lewis ................... 109 

Letter of May 14, 2008, from Minority to U.S. Food and Drug Administration 111 

Food recall lists, 2007 to present ............................................................................ 113 

News clips, dated June 12, 2008 ............................................................................ 127 

Power Point presentation ........................................................................................ 133 

‘‘Sen. Specter Says FDA Can’t Even Ask for Money Properly,’’ The Wall 

Street Journal Online, June 11, 2008 ................................................................ 113 

Letter of June 10, 2008, from Sen. Specter to U.S. Department of Health 

and Human Services ............................................................................................ 138 

Subcommittee exhibit binder .................................................................................. 139 

(1) 

AMERICAN LIVES STILL AT RISK: WHEN WILL 

FDA’S FOOD PROTECTION PLAN BE FULLY 

FUNDED AND IMPLEMENTED? 

THURSDAY, JUNE 12, 2008 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, D.C. 

The subcommittee met, pursuant to other business, at 10:04 

a.m., in room 2123 of the Rayburn House Office Building, Hon. 

Bart Stupak (chairman) presiding. 

Members present: Representatives Stupak, DeGette, Melancon, 

Doyle, Schakowsky, Dingell (ex officio), Shimkus, Whitfield, Walden, Burgess, and Blackburn. 

Staff present: John Sopko, Scott Schloegel, Chris Knauer, Keith 

Barstow, Calvin Webb, Kyle Chapman, Alan Slobodin, Peter Spencer, and Whitney Drew. 

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

Mr. STUPAK. This meeting will come to order. 

Today we have a hearing entitled ‘‘American Lives At Risk: 

When Will FDA’s Food Protection Plan Be Fully Funded and Implemented?’’ Each member will be recognized for a 5 minute opening statement. I will begin. 

Today this subcommittee is holding another in a series of hearings examining the adequacy of the efforts of the Food and Drug 

Administration to protect Americans from unsafe food. In fact, today’s hearing is our eighth hearing on this topic since January of 

last year. The purpose of today’s hearing is to receive important 

testimony from the FDA regarding how the Agency plans to address its many weaknesses concerning its ability to protect our food 

supply. 

To date, our investigation and hearings have uncovered a multitude of problems regarding FDA’s food safety efforts, including 

poor policy choices, questionable management decisions, and lack of 

resources. Collectively, FDA’s failed regulation of domestic food 

producers, its ill-conceived plan to close laboratories and reorganize 

staff, and its inability to ensure the safety of imported foods have 

suggested the Agency’s food safety system is broken. 

Outside experts have also found that the FDA’s food safety system is in trouble. In fact, in January 2007, GAO added the federal 

oversight of food safety to its High-Risk Series and called for a govVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
2 

ernment-wide reexamination of this country’s food safety system. 

GAO found numerous concerns with the present food safety system 

including inconsistent oversight, ineffective coordination, and incomplete program planning. Last year FDA’s own Science Board 

issued a scathing assessment of FDA’s food protection abilities, 

concluding the Agency ‘‘does not have the capacity to ensure the 

safety of food for the Nation.’’ In April of this year, Trust for America’s Health, a major public health watchdog organization, issued 

yet another report which also found a number of deficiencies in the 

ability of the FDA to safeguard the Nation’s food supply. 

Through all of these evaluations, one common theme has 

emerged: FDA’s resources are so stretched that its ability to protect 

Americans from unsafe food is seriously jeopardized. Perhaps the 

Science Board put it best in its report when it concluded, and I 

quote, ‘‘In contrast to previous reviews that warned crisis would 

arise if funding issues were not addressed, recent events and our 

findings indicate that some of these crises are now realities and 

American lives are at risk.’’ Indeed, the events of the last 18 

months with recall after recall demonstrate these concerns have 

now become a reality. 

In response to the multitude of foodborne contamination outbreaks and concerns about its ability to protect Americans from unsafe food, in November of last year FDA released a document entitled ‘‘Food Protection Plan: An Integrated Strategy for Protecting 

the Nation’s Food Supply.’’ The Food Protection Plan lays out a 

blueprint for addressing food safety and food defense for both domestic and imported foods. The plan attempts to prevent contamination by pursuing safety measures that will address risk through 

the life cycle of food products, but more importantly, to identify potential food hazards and counter them before they can do harm. 

The Food Protection Plan is very appealing on paper and appears 

to be a positive first step toward creating a stronger food safety 

system. Nonetheless, this subcommittee and many experts will testify today that they are concerned that the key specifics and the 

resources required to implement this plan remain elusive. As reported by GAO at our January 29th hearing, while acknowledging 

it will need additional funding, ‘‘The FDA has not provided specific 

information on the resources it anticipates the Agency will need to 

implement this plan.’’ Over 4 months later, this committee, GAO, 

and others are still attempting to obtain basic data on what resources are needed and how they will be used to implement the 

plan. 

As of Monday, it appeared the President’s budget provided only 

minimal support for making this plan a reality. The President’s fiscal year 2009 budget originally asked for a mere $51 million in new 

budgetary authority for all programs within the FDA. Approximately $42 million of this would go towards food safety. Because 

of cost-of-living salary adjustments, only about $30 million would 

be available for implementing the Food Protection Plan. 

This is in stark contrast to the Science Board’s recommendations. 

In a letter to members of this committee, it was recommended that 

an additional $375 million be provided to FDA across all programs 

in fiscal year 2009 including $128 million for food safety and $75 

million for needed IT enhancements. With the President’s original 

3 

budget offering only $30 million additional for food safety in fiscal 

year 2009, one had to ponder how serious the Administration was 

in implementing the Food Protection Plan as experts suggested the 

Agency would need far, far more. 

Fortunately, just days before this hearing, the Administration 

apparently grasped the obvious: FDA was strapped for resources 

and $30 million was not enough to credibly advance the Food Protection Plan. 

On Monday evening, HHS Secretary and the FDA Commissioner 

scheduled a conference call to announce the Administration would 

amend FDA’s fiscal year 2009 budget request to Congress and 

asked for an additional $275 million in new funding. Approximately $125 million of this would go to food safety efforts. I strongly applaud this request but we need to know far more detail about 

how this money will be spent. 

Despite the Administration’s revised budget request, a major concern of the Subcommittee and others is the Agency lacks a meaningful strategic plan detailing what the Food Protection Plan will 

cost to implement, when key milestones will be achieved and what 

are they expected to accomplish. 

Initially, a smattering of spreadsheets and other documents were 

provided to the Subcommittee by FDA that attempted to detail 

what parts of the plan would be implemented this year. These 

plans fell short in that they did not show what the overall plan cost 

to execute nor did they prioritize which features were most critical 

in fixing existing food safety shortcomings. Moreover, the vague 

plans that were provided to the Subcommittee were based on earlier budget requests, not the new request made this week. 

To this point, FDA’s strategic planning for implementing the 

Food Protection Plan appears to be almost entirely budget driven. 

Rather than articulating what really truly needs to be fixed, why 

it needs to be fixed and how fixing it would positively affect the 

current food safety system, FDA instead has tailored its implementation plan to match the meager resources offered in the President’s original budget proposal of just $30 million for food safety. 

Because both the implementation goals and the funding for the 

Food Protection Plan remain a moving target, I will today seek 

from Dr. Acheson information on whether the Administration intends to submit a comprehensive strategic plan based not on yesterday’s budget request but one based on the expected costs of a 

plan’s full implementation. In short, if the FDA is going to be successful in getting this effort funded, it must be prepared to detail 

the plan’s expected costs, strategies, milestones, and results on food 

safety. So far the plan proposes a number of lofty ideals but important specifics remain undefined. 

Today I look forward to hearing what progress has been made toward implementing the Administration’s Food Protection Plan. Additionally, I want to understand what aspects of this plan are most 

critical to achieve, what they would accomplish, and what they are 

expected to cost beyond the ever-changing budget requests that 

come from the Administration. As the Agency stated in its Food 

Protection Plan, ‘‘FDA recognizes the need to partner with Congress to make the changes necessary to transform the safety of the 

Nation’s food supply.’’ I am hoping today that the FDA will finally 

4 

be willing to enter into this partnership with us and provide a 

credible and honest answer as to what is needed to realistically 

safeguard the Nation’s food supply. 

Lastly, I would be remiss if I did not mention the current salmonella St. Paul outbreak that has led to 167 illnesses in 17 

States. This outbreak is particularly frustrating, given the fact that 

today marks the 1-year anniversary of the FDA’s Tomato Safety 

Initiative, which was supposed to lead to better safety standards 

and improve notification and tracking of tomato outbreaks. It appears that despite 1 full year having passed, we are no safer today 

than we were a year ago. At a minimum, the FDA and USDA 

should require immediate implementation of country-of-origin labeling for all fruits and vegetables sold in the United States. Country-of-origin labeling has been passed by this Congress several 

years ago. Country-of-origin labeling will provide consumers with 

more information about where their food is coming from and would 

also help Federal and State officials more quickly narrow down 

source locations of contaminated fruits and vegetables. 

My time is up. 

I next turn to the gentleman from Illinois, Mr. Shimkus, for his 

opening statement, please. 

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

Mr. SHIMKUS. Thank you, Chairman Stupak. 

As we hold this hearing, grocers and restaurants nationwide 

have been pulling tomatoes from the shelves and menus until the 

cause of a recent salmonella outbreak in some States can be identified. I tried to get a BLT sandwich in the cloakroom yesterday and 

no tomato. I had a BL sandwich. There is no evidence that the outbreak is associated with all this produce but in an abundance of 

caution, the food industry has reacted. 

There must be a more efficient way to trace problems and assure 

safety. There must be a way to harness science and reduce risk 

from pathogens we know about and perhaps those yet to emerge. 

There must be a way to effectively deploy and encourage cuttingedge technologies such as irradiation and even gene splicing to 

achieve greater safety. 

As we focus on FDA’s reform efforts this morning, it will be helpful to keep in mind the role of science and innovation to reduce risk 

and disease threats. It will be useful to explain what opportunities 

a renewed focus on science at the Agency will hold for encouraging 

innovation that truly prevents disease outbreaks. 

Today we will examine the Food and Drug Administration’s Food 

Protection Plan, which promises to improve the Agency’s ability to 

assure the safety of the food supply both domestic and imported. 

With 7 months passed since the plan’s unveiling in November, I 

look forward to a progress report from the Agency and outside observers to examine whether this plan can achieve what it promised. 

During previous food safety hearings by this subcommittee, we 

have all remarked on the need for the Agency to focus on developing a truly risk-based food safety system that is oriented towards 

the challenges of a global marketplace. We have established in past 

hearings that we can no longer rely upon border operations as the 

5 

primary line of defense to ensure imported food safety. We have established that domestic or foreign, there must be a systems approach to food safety which can more effectively prevent outbreaks 

than the current system and trace problems to the source when 

they are found. We have established the central role of modern, robust IT systems and the scientific know-how needed to keep the 

Agency on top of emerging health threats. We have also established 

that simply giving more money alone to FDA will not produce better public health protection. There need to be structural reforms 

and performance-oriented management to ensure resources are put 

to cost-effective use. 

We have called for a new regulatory model at FDA that no longer 

relies on outdated domestic-oriented posture towards the food supply. We have called for quicker deployment of smart import tracking systems at the border such as the so-called Predict system and 

the necessary restructuring for the more robust and effective foreign inspection program than the current model. 

The Food Protection Plan along with other internal efforts reflects a positive effort by the Administration to move in this direction. Another positive is Health and Human Services Secretary 

Leavitt’s recent supplemental budget request for an additional 

$275 million for fiscal year 2009. This boosts the Administration’s 

proposed budget to some $400 million over the current FDA budget 

with a sizable portion of this for food safety and cross-cutting technology improvements. How much this proposed funding will accelerate FDA reform is open to question, and Mr. Chairman, I would 

like to submit for the record a letter that the Minority sent to the 

appropriators in support of the additional request on the supplemental. 

Mr. STUPAK. Without objection. 

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

Mr. SHIMKUS. The proof will be in the pudding. There are many 

bureaucratic hurdles and imperatives that can impede legitimate 

efforts to modernize a federal agency. It is critical today that we 

discuss details associated with implementing the risk-based Food 

Protection Plan and related technology improvements. Nobody says 

this is an easy or fast project but it is important that we see the 

measures and indicators of progress so we can be assured the 

promised improvements are implemented effectively. It is also important to understand what Congress should do legislatively, and 

soon, so the Agency has the necessary tools for doing its job. 

Fortunately, we have witnesses, several repeat witnesses today, 

who can assist us. As we move through the hearing today, I look 

forward to their insights into performing and planning as well as 

into what innovative and new technologies may hold for improving 

safety. Will a repostured FDA help foster the genetic technologies 

needed to inhibit foodborne pathogens? Is this something we should 

encourage to develop in the Agency? And Mr. Chairman, representing an ag district, I have seen what GMOs have done to help 

lower pesticide use. I have seen how it has helped to lower fertilizer use, and it may be a way in which we can move in a direction with the FDA. 

I just want to end by putting the FDA on notice of a letter that 

the Minority sent on May 14 requesting a June 6th deadline on 

6 

questions in response to this research that we have done on the Office of Criminal Investigation, and I am giving them a heads-up on 

that. 

Thank you, Mr. Chairman. I yield back. 

Mr. STUPAK. Did you want to enter the May 14th letter in from 

the Minority to Commissioner von Eschenbach? 

Mr. SHIMKUS. Yes, if that is all right. 

Mr. STUPAK. Did you get a response from the Commissioner? Do 

you want to enter—— 

Mr. SHIMKUS. We do not have a response. That is why we are 

going to enter it and ask them about it. 

Mr. STUPAK. Without objection, a May 14th letter from the Minority to the Commissioner will be entered and made part of the 

record. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

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

Mr. STUPAK. Thank you. 

Ms. DeGette for an opening statement, please. 

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

Ms. DEGETTE. Thank you, Mr. Chairman. I surely appreciate 

your continuing efforts to investigate the obviously broken food 

safety system in this country. 

Little did we know when we scheduled this hearing a couple of 

weeks ago that we would now be in the middle of another national 

outbreak of foodborne illness. The salmonella outbreak in raw tomatoes has now expanded, as we know, to at least 17 States with 

167 people sick and dozens hospitalized. Businesses nationwide 

have pulled tomatoes from their shelves, leaving tons of food to rot 

and an entire industry of farmers, employees and small businesses 

in trouble, but the FDA, hobbled by dwindling resources, conflicting 

missions, cuts in staffing and low morale has not been able to identify the source of this contamination. Sadly, we have been here before. 

This salmonella outbreak is just the latest in a steady stream of 

incidents over the past year. I was just remarking to staff, the 

longer you sit on this committee, the more depressed you get because the issues never get resolved and crop up again and again. 

We were glad to hear about the Food Protection Plan last November but there is still much desirable language in the document that 

needs to be fleshed out in its details. So I am hoping that the hearing will help us specify the specifics about what the FDA will do, 

how much it will cost and, hopefully, how it will help solve outbreaks like this most recent tomato outbreak. 

I would also like to know if the Agency has learned anything 

from the previous outbreaks that it is putting to use in the current 

tomato incident. To be frank, it doesn’t seem to me like it is because we still can’t trace the source of the salmonella contamination in the tomatoes. I am encouraged that the FDA submitted to 

Congress this week a supplemental budget for the Agency. I know 

many members of the Committee were dumbfounded when the Administration originally denied a need for additional resources but 

7 

I am glad the FDA is seeking more. The question is, will this be 

sufficient to carry out its mission? And I hate to sound like a broken record in this subcommittee, but we need to create a comprehensive food traceability system so we don’t experience delays 

like we are seeing right now in the tomato outbreak. 

The events of the last few days have once again shown that the 

FDA is incapable of quickly identifying the source of contamination 

when it occurs. What exists right now in all of these industries is 

a complicated system of going through records of individual companies to locate suppliers, the suppliers’ suppliers, wholesalers, distribution centers, processing facilities, gathering warehouses, and 

farms. As we have learned this week, this process began in April 

with the tomato outbreak. Given the advanced technology today, 

this information should be easily accessible in an instant. 

In fact, traceability is already being done by individual companies and I think we should build on their successes to form a comprehensive national system. For example, we all know that UPS 

and FedEx can instantaneously locate a package anywhere in the 

world. In the food industry, Dole Foods and many beer distributors 

can trace their products throughout the supply chain. Many large 

and small businesses have developed high-tech tracing systems 

from bar coding, GPS, laser technology, and one of my companies 

in Colorado has even pioneered a process to laser numerical codes 

onto individual eggs. You can even put codes on produce like tomatoes, allowing consumers to trace the farm-to-fork distribution from 

their home computer. INM consulting is advising its clients that 

food traceability is a sound business investment, given the importance of brand preservation and risk management. 

Exciting things are happening in the field literally but sadly, the 

Federal Government has not gotten on board. Instead, once again, 

we have a food salmonella outbreak, this time with tomatoes, people getting sick around the country, but the FDA is still in its third 

month of trying to trace the source of the contamination. And what 

this does, it ripples around the industry. As I have said many a 

time, not only is traceability and mandatory recall a good thing to 

do for the consumer, it is also good for business because it avoids 

these massive recalls that really hurt production. And so obviously 

I think that we should pass my bill, H.R. 3485, the TRACE Act, 

but I also think, Mr. Chairman, that we should consider putting it 

in the draft that we are looking at in the other committee on food 

safety. 

I look forward to hearing from the witnesses this morning. Given 

the recent outbreak, I not only want to hear about general progress 

but also the progress about how we can improve food traceability 

around the country. Thank you, Mr. Chairman. 

Mr. STUPAK. I thank the gentlewoman. 

Mr. Walden for opening statement, please. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. Thank you very much, Mr. Chairman. I appreciate 

your due diligence in holding these hearings and holding the FDA 

accountable. 

8 

Obviously there are probably few things more important to parents than the safety of the food that their kids ingest, and it is almost like a conspiracy against parents. You know how hard it is 

to get your kids to eat spinach and tomatoes to begin with, and it 

seems like we are fighting over the very staples of the diet you are 

trying to get kids to eat over whether or not it is even safe. Kids 

don’t need any more excuses on that front. 

It is very disturbing that we are seeing more and more firms regulated by the FDA and fewer and fewer inspections occurring. It 

just seems backwards. At a time when our supplies, much like our 

fuel supply, is coming from other countries, it is imperative that we 

modernize and update the FDA to be able to deal with this new 

dynamic we face. There was a day in this country where we raised 

what we ate, and that day has sadly changed and gone. We still 

grow a lot of things. There is no doubt about it and that is important but I think if we are going to have security in the family and 

in the food supply, I personally believe we need country-of-origin 

labeling, and I think we need a new regulatory framework so that 

we can identify the source of an outbreak as quickly as possible. 

I have perhaps five of my fellow Oregonians who have fallen victim 

to this salmonella outbreak, three of whom are from Umatilla 

County, a rural part of my district, an agricultural part of my district, they believe have been diagnosed with this rare form of salmonella. 

So, Mr. Chairman, it strikes me that this Congress needs to take 

seriously as we do the recommendations of the science panel and 

the findings of the GAO and give the resources necessary to the 

FDA to do their job. We control the purse. It is up to us to get it 

done. 

With that, I will yield back the remainder of my time. 

Mr. STUPAK. I thank the gentleman. 

Mr. Dingell for an opening statement, please. 

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

Mr. DINGELL. Mr. Chairman, first, thank you for holding this 

hearing. It is important and it is the eighth in our series of hearings on food safety, and sadly, also upon the inadequacy of our food 

and drug laws and the inadequacy of the performance of the Food 

and Drug Administration, the Department of Health and Human 

Services, the inadequacy of their budget and the shoddy and 

shameful performance which they have so badly carried forward. 

A common theme of each of these hearings has been a major food 

recall or outbreak of illness linked to food and the Food and Drug 

Administration’s inadequate resources and incompetent management. We now can look back just with regard to food and we can 

see tomatoes, spinach, grapes, mushrooms, seafood, and dozens of 

other items which have gotten on to poison and sicken the American consumer. 

Today’s processes are no different. We face another food crisis. 

Since mid-April, there have been 145 cases of salmonella poisoning 

associated with fresh tomatoes. I am hearing some complaints from 

people who say, well, we don’t want to pay the cost of this. I would 

9 

ask how many would rather pay a modest increase in cost to avoid 

bloody diarrhea or something like that associated with salmonella, 

and do we want to pay a little bit more to get a competent Food 

and Drug Administration that properly carries out its responsibility and has the capacity to protect the American consumers? And 

we must ask, what is the point of having the best food and drug 

laws in the world if they are not enforced and if we cannot reach 

abroad to address other countries which are shipping foods, drugs, 

cosmetics, and other things into this country which threaten the 

well-being of the American consuming public. 

The outbreak that we are talking about has extended to 16 

States, 23 hospitalizations. It has sickened people. It has devastated an industry. It has cost consumers, producers, and retailers 

millions of dollars. Tragically, similar food crises have occurred in 

the past, as I have mentioned. Food and Drug cannot even identify 

the source of contamination or to know where the tomatoes which 

are poisoning Americans have originated. These continued outbreaks are unacceptable. To have Food and Drug come up and say 

they don’t know what to do about it or how much money they need 

or what resources they require is a shame and a disgrace, and this 

committee, in a bipartisan fashion, is not going to tolerate that 

kind of nonsense and we are going to come forward with legislation 

which is going to do the job of protecting the American people and 

we will begin addressing the problem plaguing the Nation’s food 

safety system. 

My colleagues and I have proposed in an April draft discussion 

legislation outlining comprehensive changes needed to improve the 

safety of domestic and imported food as well as drugs and medical 

devices. This proposal will give FDA the resources and the authority necessary to protect Americans, something which I believe that 

they want and something, Mr. Chairman, which your hearings are 

shining a spotlight upon so the people may understand the choices 

that are before them on this matter. 

Today’s hearing examines the Administration’s proposed Food 

Protection Plan announced last November, which illustrates the 

challenges we face in protecting this Nation from foodborne illnesses. On paper it looks good. It calls for preventing contamination by pursuing safety measures that address risks through the 

life cycles of food protects and countering food hazards before they 

do harm, admirable goals that no one will oppose. Unfortunately, 

the plan lacks the details of what is needed to meet these goals, 

including the money that is needed to pay for them. Since this plan 

first surfaced, this committee and the Government Accountability 

Office at our direction have made repeated requests for details 

about this effort but to no avail. If the President’s initial budget for 

the fiscal year 2009 allocation was any indication of how seriously 

the Administration takes this plan, I fear for the plan’s success and 

I seriously question the bona fides of the makers of the plan. The 

President’s original budget asked for a mere $51 million in new 

budgetary authority for the FDA programs while requesting only 

$30 million in a new budget authority for implementing the Food 

Protection Plan, an amount that everyone who has looked at it 

views as inadequate. 

10 

My concern that the Administration’s plan may be smoke and 

mirrors was heightened by Tuesday night’s hastily arranged conference call between Secretary Leavitt, Commissioner von 

Eschenbach, and select members of the press. It was only then, 

within just a few days of this hearing, that the Administration announced that they would seek an additional $275 million in new 

funding including $125 million specifically for food safety, a rather 

laughable process, I would observe, criticized by my good friend, 

Senator Specter, in a letter which is now available in the press, 

and in a rather excellent commentary in the Wall Street Journal, 

which says, ‘‘Senator Specter says FDA can’t even ask for money 

properly.’’ What a shame. 

The Food Protection Plan may be a solid first step in how to protect our people and to fix a broken food safety system but it won’t 

work worth a whoop if the Administration does not see to it that 

we have enough money and does not show greater signs about 

being serious about this plan. The Administration is going to have 

to work with us to provide the details and to assist us in drafting 

the legislation to fix the current system, including a realistic assessment of its resource requirements. 

I do look forward to the testimony from today’s expert witnesses 

about what is really needed to protect Americans from unsafe food 

and I commend you, Mr. Chairman, for this hearing. We are also 

going to hear from the FDA’s food czar, who we hope will not provide us with more Potemkin villages but rather will be candid and 

forthcoming in giving us and the American people the truth about 

what is needed to fix a difficult system which is crowned by incompetence, indifference, inadequacy, and a gross shortfall in funding 

and leadership. 

Thank you, Mr. Chairman. 

Mr. STUPAK. Thank you, Mr. Dingell. 

Ms. Blackburn for an opening statement, please. 

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

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

hearing and for updating the Subcommittee on the Administration’s Food Protection Plan. I am sure the public is very much 

aware of the issue that is before us with salmonella and the tomatoes. We are hearing about it from so many members on this committee this morning. I think it is worth noting that U.S. growers 

produced $1.3 billion worth of tomatoes last year and that this current outbreak will devastate that industry. So yes, indeed, it is an 

issue that is of concern to us for the health of our citizens but it 

also is an issue of economics for our agricultural community and, 

fortunately, our good Tennessee-grown tomatoes are safe and we 

will be able to enjoy those. 

We have held a lot of hearings on this, Mr. Chairman. I think 

this is our seventh or eighth hearing, and we know it is time for 

action. People are so weary of rhetoric and talk and saying we have 

a plan but nothing gets done. I was sitting here reading the Wall 

Street Journal and here we go, A4, there is another story about the 

FDA and your inability to take action. My goodness gracious, cerVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00016 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
11 

tainly this issue should rise to a level of importance to you, and 

you have had time. It was November 2007 when the FDA released 

its Food Protection Plan and how you were going to improve your 

food safety and surveillance system, and we are still waiting. The 

FDA needs to shift its focusing from reacting to food safety 

breaches following contamination and instead start looking at implementation and prevention policies. Your fiscal year budget for 

food safety was over $560 million. The agency would benefit from 

increased resources to meet the demands of globalization on the 

Nation’s food and drug supply but we need to see some action from 

you. 

I hope that you will show that this rises to a priority for you and 

I will say, Mr. Chairman, it continues to be troubling to me that 

we continue to hear about a lack of interagency communication, a 

lack of 21st century IT systems and a lack of best practices to 

streamline safety review efforts. We have asked for those best practices, and I am curious if they exist because they tend to not be 

presented to us. This is an issue of accountability. We know you 

have the ability to perform these tasks. We would seek from you 

recognition of the need for this to be a priority and recognition that 

accountability is required. 

Mr. Chairman, I thank you for the time. I yield back the balance 

of my time and look forward to the hearing. 

Mr. STUPAK. Thank you. 

Mr. Doyle for an opening statement, please. 

OPENING STATEMENT OF HON. MIKE DOYLE, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. DOYLE. Thank you, Mr. Chairman. As you mentioned in your 

opening statement today, this marks our eighth hearing on food 

safety, and Mr. Chairman, I want to thank you for your tenacity 

and engagement into ensuring our Nation’s food supply is as safe 

as possible. 

I have to say that I am pleased the Administration is amending 

its FDA funding request in this year’s budget. The extra $275 million will be great to help ensure the safety of our food, drugs, cosmetics, and medical devices but it is worth pointing out, as others 

have, that it falls $100 million short of the amount FDA’s own advisory board determined is needed. 

Mr. Chairman, as a member of the Subcommittee on Telecommunications and the Internet, I must say that I am dismayed 

at the many problems FDA is having updating its antiquated information technology infrastructure. IT is the backbone of an information-based workforce. It is the work you have to do first before you 

can get any other work done. When your computers are down, it 

is hard to get work done. When you are not giving employees the 

right technological tools, it is hard to encourage them to be entrepreneurial about their work. Those failures make doing the important day-to-day work critical to our Nation’s safety extremely difficult. It is no wonder that the FDA performed more than double 

the number of foreign and domestic food establishment inspections 

in 1973 as they performed in 2006. It is no wonder that the folks 

12 

at GAO have outlined dozens of suggestions and recommendations 

to improve FDA that haven’t been acted upon. 

Mr. Chairman, I look forward to their testimony this morning as 

I do for all the witnesses, and hopefully with suggestions to improve our food supply. With that, Mr. Chairman, I won’t take up 

too much more of the Subcommittee’s time. I would rather listen 

to what the witnesses have to say and ask some questions, and I 

will yield back. 

Mr. STUPAK. I thank the gentleman. 

Mr. Burgess for an opening statement, please. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman, and I too will try to be 

brief because most of this stuff we have heard already. It is our 

eighth Subcommittee hearing. 

The title of this hearing is interesting: ‘‘When Will the FDA’s 

Food Protection Plan be Fully Funded and Implemented.’’ It is kind 

of ironic. I may only be a third-term Member but from my recollection of civics, funding of federal agencies is partly our job in Congress. So we know what the problem is. We have had eight hearings. We had a lot of testimony. We have seen the consequences. 

Let us start addressing them. That is what the American people 

want and what they deserve, and the issue of protecting people and 

products is not always easy. 

We live in a free society and the government is faced with certain challenges and tradeoffs when it comes to safeguarding the 

public and ensuring their freedom. One of the biggest is, how do 

we protect people without encroaching upon their freedom? It is a 

complex challenge but it doesn’t lessen our obligation of keeping 

Americans safe. It is right there in the first sentence of the Constitution. It is time that this Congress start living up to that core 

responsibility. 

I hope the committee today can take some of the first steps to 

protect our food supply and protect our citizens. We are pretty well 

past the point of more finger pointing. I think there is enough culpability on all sides to go around but this committee needs to get 

down to work in a truly bipartisan manner and fill in some of the 

details of this FDA Food Protection Plan. Based on the title of this 

hearing, I wonder if both sides of the dais see great merit in this 

food safety proposal. Let us move forward in two simple steps. First 

is to legislate, and two, put the pen in the appropriators’ hands and 

let them write the check. 

Yesterday, myself and several members on this side of the dais 

signed a letter supporting the inclusion of the $275 million for the 

Food and Drug Administration in the supplemental appropriations 

bill that we are reportedly, allegedly going to vote on some time 

this month. This plus the additional requested sums in the baseline 

budget should meet the needs of the FDA, and I would just point 

out that the dollar amount requested for food protection by the 

science panel was $128 million, and with the baseline budget and 

the supplemental money, this will be $125 million, pretty close to 

what they requested. So there is no excuse. We know what the 

13 

problem is. We know what the target funding is. Again, let us put 

the pen in the appropriators’ hands and write the check. 

It is impossible to regulate the food safety system down to zero 

percent foodborne illness. We all know that. It is also possible to 

change some of our technologies so we are not always having to be 

reactive but we can be a little bit more proactive, but for whatever 

reason, we have chosen to leave those technologies on the shelf and 

not use them. Maybe we need to rethink some of those processes. 

Are there ways? We understand that the salmonella organism in 

the tomato problem is not just on the surface of the tomato but 

maybe in the vasculature of the tomato so washing won’t always 

solve the problem. Is there another method for eradicating the salmonella in the tomato before it reaches the consumer? We could irradiate. Some people have a problem with that. Well, we have to 

have the discussion and the debate and get past that problem. 

This Committee should be about solutions. It should be 21st century results-oriented. The innovation is out there, whether it be irradiation, some of the activities that can be done with gene splicing. There are additional methods of prevention that we could be 

taking and that we just elected not to. It has been stated over and 

over again. This is the eighth oversight hearing. Really, it is time 

to stop talking. This is a bipartisan issue. We all agree that there 

needs to be a solution. Let us legislate, authorize and then write 

the check and get this problem solved. 

I yield back. 

Mr. STUPAK. I thank the gentleman. I take it by your opening 

statement you will cosponsor Mr. Dingell’s FDA globalization safety 

bill—— 

Mr. BURGESS. Will the gentleman yield? 

Mr. STUPAK. Sure. 

Mr. BURGESS. I have some problems with the legislation that Mr. 

Dingell has outlined and I prepared a letter to the chairman on 

that and so we can work on those issues. I don’t think I am prepared to cosponsor the legislation at this point. There are, as I see 

it, some problems within the legislation. One of the problems is, it 

is a bipartisan committee. I mean, both sides should sit down and 

work on this legislative product before it just gets given to us. It 

is a whole lot easier to work through this process at the staff level 

rather than trying to amend the product. You know, we get the legislation and take it or leave it. Well, I am going to try to help as 

best I can but the reality is, it would have been far better if Mr. 

Dingell, Mr. Barton and some of us on the Subcommittee had sat 

down and worked out those problems before the legislation was delivered, and I yield back. 

Mr. STUPAK. Well, thank you. We look forward to your letter because we have been working with Mr. Barton and we are making 

progress on it but we always value your input into the process. 

Thank you. 

Ms. Schakowsky for an opening statement. 

14 

OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. I want to commend 

you for holding this hearing regarding the crucial legislation and 

for all your hard work on improving our Nation’s food safety. 

I have been proud to participate in the seven hearings on food 

safety the Subcommittee has held this Congress which have revealed a number of truly shocking revelations about the major gaps 

in our food safety system. Once again, it is clear that the FDA is 

unable to ensure that the food that we serve on our dinner tables 

each night won’t make us sick. 

Americans are more and more worried about the safety of the 

food they eat and rightly so. Last week’s tomato salmonella scare 

sickened 167 people in 17 States, and every week another food recall is announced, it seems. Jars of Peter Pan peanut butter containing salmonella, cans of green beans containing botulism, spinach tainted with E. coli, poisoned pot pies, the largest meat recall 

in the history of our country, 143 million pounds of recalled beef 

of which 50 million pounds were sent to the school lunch program 

in February. Earlier this month salmonella was found in Puffed 

Rice and Puffed Wheat cereals produced by Malt-O-Meal. Tainted 

cantaloupes caused a scare in March. As a mother and a grandmother, I should not have to worry about whether I am serving my 

family contaminated food. 

That there are 76 million foodborne illnesses in this country each 

year is simply unacceptable. It demonstrates that there are real 

gaps in our food safety system, a system which doesn’t come close 

to reflecting the technological advancements in the wealthiest and 

most powerful nation on earth, and given its track record and lack 

of resources, I am concerned about FDA’s ability to enact the Food 

Protection Plan. I am particularly concerned about FDA’s lack of 

willingness to share their plans with Congress and the public. The 

FDA Modernization Act, which we are beginning to consider in the 

Energy and Commerce Committee, has strong language which 

gives the FDA greater authority and more resources to perform 

their mission. This is especially true of food manufactured overseas, by giving the FDA the tools it needs to conduct inspection of 

foreign facilities. This legislation takes bold steps to prevent problems before they occur on U.S. soil. And by finally giving the FDA 

mandatory recall authority, we are giving the Agency the teeth it 

has been missing to stop corporations and companies that do not 

stand up to their responsibilities to follow the law and keep the 

public safe. 

So I am looking forward to working with the committee to 

strengthen that legislation. If the FDA had this authority now, perhaps hundreds of people would not have been exposed to salmonella and millions of tomatoes would still be on the store 

shelves. Consumers expect no less from their government. 

Mr. Chairman, I thank you again for convening this hearing and 

I look forward to hearing from our witnesses and yield back the 

balance of my time. 

Mr. STUPAK. Thank you. 

That concludes the opening statements of all members. I want to 

thank all members for being here promptly. We did the business 

15 

meeting and now we will start this meeting. I realize there is another Subcommittee meeting at this same time, the Environment 

and Hazardous Materials Subcommittee, so members will be moving in and out, and we welcome their participation. 

Since that concludes the opening statements by members of the 

Subcommittee, I now call our first panel of witnesses to come forward. On our first panel we have Dr. Gail Cassell, Vice President 

of Scientific Affairs and Distinguished Lilly Research Scholar for 

Infectious Diseases at Eli Lilly and Company. Dr. Cassell is also 

chair of the Subcommittee on Science and Technology of the FDA’s 

Science Board. Dr. J. Glenn Morris, Jr., Director of the Emerging 

Pathogens Institute at the University of Florida. Dr. Morris is also 

an external advisor to the FDA’s Science Board’s Subcommittee on 

Science and Technology. Mr. Michael R. Taylor, Research Professor 

of Health Policy at the George Washington University School of 

Public Policy and Health Services. Dr. Jeffrey Levi, Executive Director of the Trust for America’s Health, and Ms. Lisa Shames, Director of Food and Agricultural Issues at the Government Accountability Office. 

It is the policy of this subcommittee to take all testimony under 

oath. Please be advised that you have the right under the Rules of 

the House to be advised by counsel during your testimony. Do you 

wish to be represented by counsel? With the nodding of heads, I indicate no one wishes to be represented by counsel. Therefore, I am 

going to ask the witnesses to please rise and raise your right hand 

to take the oath. 

[Witnesses sworn.] 

Mr. STUPAK. Let the record reflect that the witnesses replied in 

the affirmative. Each of you is now under oath. We will now hear 

5 minute opening statements from our witnesses. You may submit 

a longer statement for inclusion in the record. 

Ms. Shames, we will start with you, please. We will go from my 

left to the right. We will go right across. 

STATEMENT OF LISA SHAMES, DIRECTOR, FOOD AND AGRICULTURE ISSUES, U.S. GOVERNMENT ACCOUNTABILITY OFFICE 

Ms. SHAMES. Chairman Stupak, Ranking Member Shimkus and 

members of the Subcommittee, I am pleased to be here today to 

discuss FDA’s progress in implementing its Food Protection Plan. 

As you will recall, we testified last January before the subcommittee that FDA’s plan proposes positive first steps. However, 

we expressed concerns that it would be difficult for Congress to assess the likelihood of the plan’s success without a clear description 

of the resources and strategies needed to implement it. 

I would like to make three points today. First, since January, 

FDA has added few additional details on the resources and strategies it needs to implement the plan. Second, FDA has implemented 

few of GAO’s recommendations that could help it leverage resources and improve enforcement, and third, in terms of FDA’s current resource level, its proposal to focus inspections based on risk 

has the potential to be an efficient and effective approach, especially since FDA’s inspections have decreased while the number of 

food firms under its jurisdiction have increased. 

16 

First, regarding resources and strategies, we testified last January that FDA had not provided specific information on the resources and strategies needed to implement the Food Protection 

Plan. Since then, FDA has added few details. FDA acknowledges 

that additional resources are required to implement the Food Protection Plan, and is directing a portion of its 2008 and 2009 budget 

to that end. However, FDA’s overall resource needs are unclear and 

those resource needs could be significant. For example, if FDA were 

to inspect the over 65,000 domestic food firms under its jurisdiction, it would cost approximately $524 million. This figure underscores the need for FDA to focus on a risk-based approach. Based 

on our review of draft internal documents, FDA appears to be refining its planning process. These internal documents provide some 

additional information. Nonetheless, we continue to have concerns 

about the lack of specificity. For example, we were told the Food 

Protection Plan would take an estimated 5 years. However, FDA 

has not provided us with the timelines for the plan’s strategic actions and their associated action steps and deliverables. Without 

this type of information, we are not able to assess whether FDA’s 

estimated time frame is feasible. 

We also testified in January that FDA planned to keep the public 

informed of its progress in implementing the Food Protection Plan. 

To date, FDA has not done so. While we were provided a list of various accomplishments, they were compiled from numerous public 

sources. Having such information in a consolidated document that 

is readily accessible reassures Congress and the public that actions 

have been taken. Ultimately, at a minimum, the information we 

are seeking is along the lines of a results-oriented strategic plan 

that identifies long-term and interim goals and identifies necessary 

resources including funding, human capital and information technology to achieve them. Publicly reporting on progress made 

against those goals facilitates congressional oversight, fosters accountability and promotes transparency. 

Second, regarding GAO recommendations, FDA has implemented 

few of our past food safety-related recommendations. Of the 34 recommendations we made since 2004, FDA has fully implemented 

seven. It should be noted that FDA has started to take some steps 

on most of the remaining recommendations. Among our recommendations was for FDA to make it a priority to establish 

equivalence agreements with other countries. We found such agreements would shift some of FDA’s oversight burdens to foreign governments. We also recommended that FDA consider an accreditation program for private labs and a certification program for thirdparty inspectors. None were fully implemented. In light of the Federal Government’s long-term fiscal challenges, agencies including 

FDA need to seek out opportunities to better leverage their resources. The Food Protection Plan’s proposals could help address 

several of these recommendations. For example, it requests Congress to allow FDA to enter into agreements with exporting countries to certify that foreign producers’ shipments of designated 

high-risk products comply with FDA standards. 

Lastly, regarding risk-based inspections, the Food Protection 

Plan identifies the need to focus safety based on risk. Conducting 

inspections along these lines has the potential to be an efficient 

17 

and effective approach for FDA to target scarce resources, which is 

particularly important as the number of food firms has increased, 

while inspections have decreased. For example, between 2001 and 

2007, the number of domestic firms increased from about 51,000 to 

over 65,000 while the number of firms inspected declined, albeit 

slightly. More significantly, the number of foreign food firm inspections that FDA conducted has declined from 211 in 26 countries to 

96 in 11 countries. 

To conclude, FDA’s Food Protection Plan can only be as effective 

as its implementation. Additional detail along with public reporting 

on the progress that has been made provides FDA a valuable opportunity to reassure Congress and the public that it is doing all 

it can to protect the Nation’s food supply. 

Mr. Chairman, this concludes my prepared statement and I 

would be pleased to respond to any questions that you or members 

of the Subcommittee may have. 

[The prepared statement of Ms. Shames follows:] 

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Mr. STUPAK. Thank you for your testimony. 

Dr. Cassell, your testimony, please. 

STATEMENT OF GAIL H. CASSELL, PH.D., VICE PRESIDENT, 

SCIENTIFIC AFFAIRS AND DISTINGUISHED LILLY RESEARCH 

SCHOLAR FOR INFECTIOUS DISEASES, ELI LILLY AND COMPANY 

Ms. CASSELL. Good morning, Mr. Chairman, members of the 

Committee. I appear before you today, as you have stated, as a 

member of the FDA’s Science Board, the advisory committee to the 

Commissioner, and as the chair of the subcommittee of the Science 

Board that was asked in December of 2006 to assess the state of 

science and technology at the Agency for its ability to address their 

current responsibilities as it relates to the protection of the public’s 

health. 

On December 3, 2007, the Science Board subcommittee presented 

the results of our findings to the full Science Board. The Science 

Board accepted the report as final and dissolved the subcommittee. 

The record of the proceedings of that meeting will show that due 

to the seriousness of the deficiencies found and the urgency of the 

situation, the Science Board was adamant that the report be broadly disseminated among the public and policymakers. The level of 

concern by all members of the subcommittee and the Science Board 

to a person was and remains very high, and thus the intensity of 

our commitment to this review and to see that in fact the recommendations of this committee are fully understood and the urgency appreciated. On behalf of our subcommittee, I again want to 

thank this committee for your interest and attention to the report. 

As you have heard me say before, this subcommittee review was 

unique in many respects. First, it is only the second time in over 

a century that the Agency has been reviewed by an external committee as a whole entity. Second, the committee was composed of 

leaders not from a single sector but industry, academia, other governmental agencies. I won’t belabor that. You have heard me say 

that before. It is in my written testimony. But I would point out 

on this committee that we did have a former Assistant Secretary 

of Health, a former Under Secretary of Agriculture responsible for 

food safety, a former Chief Counsel of the FDA, and almost 50 percent of the members were members of the National Academy of 

Sciences, including one Nobel laureate. We worked for over a year. 

It was the rule, not the exception, that almost all members were 

actively engaged and present in our deliberations. Let me assure 

you one more time that this level of engagement by a committee 

is not the norm. Trust me. I have served on enough committees of 

this type. 

I would just say that also it is very rare that a committee would 

reach consensus so rapidly. You might ask then why were we able 

to achieve consensus and why the committee to this exercise, and 

quite simply, it was, it became readily apparent that FDA suffers, 

as you have heard this morning, from serious scientific deficiencies 

and is no way positioned to meet current or emerging regulatory 

responsibilities. It is agency-wide. It is not limited to a single program or center. Since every regulatory decision must be based upon 

the best available scientific evidence in order to protect public 

36 

health, we concluded lives were at risk and that there was an urgent need to address the deficiencies. Quite simply, we concluded 

that FDA can no longer fulfill its mission without substantial and 

sustained appropriations. 

Many of you this morning have suggested that you are eager to 

hear what we would tell you about the new scientific technologies 

that would be applied to the food safety system. I am here to tell 

you today that in the hearing you may remember that was held by 

your committee on January 29, that in fact Dr. Porter from the 

congressional Research Service presented a slide to you which 

showed that the resources for the FDA for conducting research has 

declined by 50 percent since 1993. For food safety, you should appreciate that that amount has declined 67 percent. It is absolutely 

essential if in fact the Agency is to have the best and most up-todate technologies that they do have the resources. 

For that reason, when we were asked by this committee to provide our best judgment in terms of resources needed, you have already alluded to the fact that we requested $375 million in 2009. 

This was in great contrast, of course, to what you have already 

heard of the $50.7 million requested by the Administration. We are 

encouraged that the Administration’s fiscal year 2009 budget 

amendment acknowledges the FDA’s needs for $275 million to address serious safety issues but unfortunately, this amount is not 

sufficient to address all the deficiencies we found including the IT 

deficiencies and drug safety issues, and most importantly, with respect to food safety, it does come very close to what we recommended but appreciate it doesn’t include the IT component in 

that $128 million we recommended for food safety. 

We also wanted to point out that if it were not to become available until 2009, this is not in time. As we have all just heard about 

the tomato outbreak with salmonella, 23 hospitalizations, over 145 

people sickened, and plus over $51 million lost in the space of just 

a few weeks. I also would point that in fact we also have had the 

81 deaths from the heparin contamination. Therefore, it is urgent 

and we urge you to include the $275 million for FDA in the supplemental appropriations bill currently being considered by the House 

and Senate in order to get the critically needed funds flowing. 

You will hear this morning from Dr. Glenn Morris, a member of 

the subcommittee, in detail about what the specific findings were 

that relate to food safety. You will also hear our concern about the 

lack of specificity in the Agency’s Food Protection Plan and the fact 

that we need a strategic implementation plan. We need to know 

what technologies are going to be utilized, how long this will take, 

and I thank you for your attention and conclude my comments. 

[The prepared statement of Ms. Cassell follows:] 

STATEMENT OF GAIL H. CASSELL, PH.D. 

Mr. Chairman and Members of the Subcommittee, I am Gail H. Cassell, Vice 

President for Scientific Affairs and a Distinguished Research Scholar for Infectious 

Diseases of Eli Lilly and Company and Professor. I am also Professor and Chairman 

Emeritus of the Department of Microbiology of the University of Alabama Schools 

of Medicine and Dentistry. I am a member of the Institute of Medicine of the National Academy of Sciences and am currently serving a second term on the governing board of the IOM. Of relevance to my testimony today, I have previously 

been a member of the Advisory Committees of the Directors of both the Centers for 

37 

Disease Control and the National Institutes of Health. I also co-chaired the congressionally mandated review of the NIH intramural program. I appear before you today 

as a member of the FDA Science Board, Advisory Committee to the FDA Commissioner as I have done so twice before this year. As you know I served as Chair of 

the Subcommittee on Science and Technology of the Science Board, which authored 

the report ‘‘FDA Science and Mission at Risk’’. 

In December 2006, the Commissioner charged the Science Board with establishing 

a subcommittee to assess whether FDA’s current science and technology can support 

the Agency’s statutory mandate to protect the Nation’s food and drug supply. The 

subcommittee was comprised of three Science Board members and 30 other experts. 

The subcommittee formally presented its report to the Science Board and FDA on 

December 3. 

The report was unanimously endorsed by each of the 33 members of the subcommittee and the full Science Board. On December 3, the Science Board accepted 

the report as final and dissolved the subcommittee. The record of the proceedings 

of that meeting will show that due to the seriousness of the deficiencies found and 

the urgency of the situation, the Science Board was adamant that the report be 

broadly disseminated among the public and policy makers. The level of concern by 

all members of the subcommittee and the Science Board members was, and remains, 

high.and thus the intensity of their commitment to this review. On behalf of our 

subcommittee, I again want to thank you Mr. Chairman and members of your committee for your attention to our report. 

The subcommittee review was unique in many respects. First, it is only the second 

time in over a century that the Agency has been reviewed by an external committee 

as a whole entity. Second, the committee was composed of leaders, not from a single 

sector, but from industry, academia, and other government agencies. The expertise 

and level of accomplishments of the members are almost unprecedented in a single 

committee, especially considering their breadth and knowledge in regulatory science 

and understanding of the mission of the Agency. 

The subcommittee included expertise ranging from a Nobel laureate in pharmacology, 14 members of the National Academy of Sciences (including two engineers), 

a renowned economist and specialist in workforce issues, a leader in health care policy and technology assessment, a former CEO of a large pharmaceutical company, 

a former Assistant Secretary for Health and Human Services who also headed global regulatory affairs within a large company for over 20 years, a former Chief Counsel for the FDA, and the first Under Secretary for Food Safety at the U.S. Department of Agriculture overseeing the Food Safety and Inspection Service and coordinating U.S. Government food safety policy. 

For over a year, this group of experts worked intensively for thousands of hours, 

including many nights, weekends, and holidays conducting their review. It was the 

norm, not the exception, that when we met, even by teleconference, we would have 

as many as 30 members actively engaged in discussion for over 2 hours. Let me assure you, this level of engagement by so many very busy people with diverse expertise is rare in such a committee let alone that there would be such rapid consensus 

about its findings. How then do you explain the consensus and commitment to this 

exercise? 

It became rapidly apparent that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. It is agency-wide, i.e. not limited to a single program or center. Since every 

regulatory decision must be based upon the best available scientific evidence in 

order to protect the public’s health, we concluded that American lives are at risk 

and that there is an urgent need to address the deficiencies. Quite simply we concluded that FDA can no longer fulfill its mission without substantial and sustained 

additional appropriations. 

On February 25, in response to your request, we submitted a summary of the estimated resources required to implement the recommendations made by our Subcommittee which included $375M in FY 2009. This was in great contrast to the 

$50.7M requested by the Administration for FY 2009. We are encouraged that the 

Administration’s FY 2009 budget amendment acknowledges the FDA’s need for 

$275M to address serious safety issues. Unfortunately, we do not believe this 

amount is sufficient and most importantly, even if it were, it would not be available 

until March or April of 2009 at the very earliest. 

Just within the past 2 months there have been 81 deaths in this country from 

contaminated heparin. Just this past week, the Centers for Disease Control has reported there have been 23 hospitalizations and 145 people sickened from salmonella 

contamination of fresh tomatoes. The later alone has cost the food industry over 

$51M in the last few days. Mr. Chairman, if we do not act now to address the deficiencies at FDA, we will see more lives lost and greater economic losses. We thereVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
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fore urge you to include $275M for FDA in the Supplemental appropriations bill currently being considered by the House and Senate in order to get the critically needed funds flowing rapidly. 

You will recall in the hearing held by your committee on January 29, we summarized the overall findings of our subcommittee. In the hearing you held, April 22, 

findings concerning drug safety and foreign inspections were extensively discussed. 

However, our subcommittee found the most serious deficiencies to be in the area of 

food safety. Today you will hear from Dr. Glenn Morris, a member of our review 

group about our specific concerns and recommendations about food safety. In addition, you will hear about our concern that the Agency’s current Food Protection Plan 

lacks specificity regarding the actions to be taken, technologies to be utilized, and 

mechanisms of implementation. I will now defer to him and the other panel members to discuss these issues in greater detail. 

Mr. STUPAK. Thank you, Doctor. 

Dr. Morris for an opening statement, please. 

STATEMENT OF J. GLENN MORRIS, JR., M.D., M.P.H., T.M., DIRECTOR, EMERGING PATHOGENS INSTITUTE, UNIVERSITY 

OF FLORIDA 

Dr. MORRIS. Mr. Chairman, members of the Committee. It is a 

pleasure to have the opportunity to speak before you today to review the findings of the report of the FDA’s Science Board Subcommittee on Science and Technology on which I had the pleasure 

of being a member. In the second part of my testimony I would like 

to expand my remarks beyond the report to deal at a more general 

level with the ability of FDA to identify and control risks in our 

U.S. food supply. 

The subcommittee’s report was entitled ‘‘FDA Science and Mission at Risk,’’ which I think correctly emphasizes the critical nature 

of the current situation at FDA. To quote from the report, ‘‘FDA 

does not have the capacity to ensure the safety of food for the Nation. Crisis management at FDA’s two food science centers, Center 

for Food Safety and Applied Nutrition and Center for Veterinary 

Medicine, has drawn attention and resources away from FDA’s 

ability to develop a science base and infrastructure needed to efficiently support innovation in the food industry, provide effective 

routine surveillance and conduct emergency outbreak investigation 

activities to protect the food supply.’’ I would say that I very 

strongly support these conclusions. 

As highlighted in the committee report, the current situation reflects decades of neglect of CFSAN and CVM resource needs, and 

again, this has been noted multiple times already this morning. 

Just to note one, to me, particularly insightful point: since 2003, 

CFSAN’s workforce has declined from 950 FTE to 771 FTE, and 

this is at a time when there have been increased demands on the 

Agency brought on by an increasingly complex food supply, rapidly 

expanding internationalization of markets as well as increasing 

regulatory responsibility. The problems in CFSAN and CVM have 

been further exacerbated by major outbreaks and recalls which, of 

necessity, divert resources away from ‘‘routine’’ scientific surveillance and regulatory activities. 

In the absence of a clearly articulated vision for food safety in 

this country, it is difficult to come up with a dollar amount for 

what it is going to take to get everything working again. However, 

the subcommittee, in response to the request of this committee, deVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
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veloped cost estimates for beginning the rebuilding process in the 

Agency, and again, as has already been mentioned, the numbers 

that we put forth were approximately $128 million for fiscal 2009 

with a cumulative increase of $775 million in annual budget by 

2013. Again, I would strongly emphasize that that does not include 

the IT component, which is an absolutely critical component. The 

increase that is being proposed by the Agency at this point in time 

begins to move toward the number we put forward, but without the 

IT component. We are still not there yet. 

Food safety remains a critically important area of concern to the 

U.S. public as has been demonstrated by the current problems with 

tomatoes. The latest outbreak always gets the headlines, and is 

what we tend to focus on. What I would comment on, speaking as 

an epidemiologist, is that the reported incidence rates for the major 

foodborne pathogens, based on 2007 FoodNet data, have remained 

relatively constant during the past several years with some actual 

increases. FoodNet was a system we put in place back in the mid1990s to give us a means of monitoring the outcome of the new 

HACCP food protection plan at USDA. I was with USDA at the 

time and was instrumental in putting the plan in place. FoodNet 

showed that we had an initial drop in incidence of foodborne disease in this country after implementation of the HACCP rules, 

which suggests that there was a definite public health impact resulting from these landmark regulatory changes. However, this decrease has leveled off over the last several years, underscoring the 

need for new and innovative approaches to protect the health of the 

American people. We did a good job at USDA. We need to do something at FDA to really begin to address these concerns. 

There is a broad consensus that the Agency must develop a 

proactive risk-based and science-based preventive approach to food 

safety. Some of the key elements of such an approach have been 

articulated by the Agency with the announcement of their Food 

Protection Plan. However, as has already been noted, questions remain about implementation and the extent of the FDA vision. I 

would highlight three specific areas. 

First of all, development of a risk- and science-based approach to 

prevention requires science. To quote from the initial subcommittee 

report, ‘‘There is a critical need to develop a cadre of professionals 

capable of applying the new biology, chemistry, and bioinformatics 

to the regulation of foods that exist in the manufacturing, distribution and consumer use environment of today’s global marketplace.’’ 

We need to have the scientists in place. We need to have the ideas 

and the vision to set the priorities and to be able to develop the 

risk-based system we have talked about. This is both laboratory 

science but it also a need for epidemiologic capabilities. It is a need 

for high-quality surveillance. 

This also has to be combined with a strong analytic capability 

both to guide the original data collection and to make sense of the 

data when they are collected. In this regard, many of the European 

countries such as the Netherlands and Denmark are well ahead of 

us, having in place well-designed surveillance systems that are 

used to regularly tweak the approaches and focus areas of the associated food safety regulatory agencies. Development of public 

health-based performance standards which long term are a critical 

40 

*Dr. Morris is Director of the newly established Emerging Pathogens Institute (EPI) at the 

University of Florida, Gainesville, where he is also a Professor of Medicine (Infectious Diseases). 

From 1994-96, Dr. Morris worked with the Food Safety Inspection Service, USDA, on development of the new HACCP regulations, and was instrumental in the establishment of FoodNet, 

the national surveillance system for foodborne illness. He has served on four National Academy 

of Sciences expert committees dealing with food safety, and currently serves on the Institute 

of Medicine’s Food and Nutrition Board. Most recently, Dr. Morris served as a member of the 

FDA Science Board’s Subcommittee on Science and Technology, which was responsible for the 

February, 2008 report ‘‘FDA Science and Mission at Risk.’’ ** Report of the Subcommittee on Science and Technology, FDA Science and Mission at Risk, 

November, 2007, p.3. 

element of a risk-based prevention system requires an even higher 

level of sophistication and surveillance and analysis. Unfortunately, the capacity at FDA for such analysis is limited and there 

is at best a clouded vision of what is needed for actual implementation of such systems. 

The second thing, no matter how good the science, the Agency 

will not be able to move forward in the absence of an appropriate 

legislative mandate. Again, I will leave that to the comments made 

by other members of this panel and others this morning. 

And of course, finally, the third point, there is a need for a substantial increase in the budgets for CFSAN and CVM. The estimates that we provided again are a starting point. The actual 

amounts necessary will almost certainly change depending on the 

extent of the Agency’s vision and their approaches to implementation. In the long run, prevention is unquestionably cost effective. 

However, we have a great deal of rebuilding to do before we can 

begin to realize such cost savings. 

FDA science is at a critical juncture with the negative impact of 

declining resources being felt perhaps most strongly in the food 

safety area. I would urge the Committee to work to rebuild its resource base and provide the necessary underlying legislative mandate as part of an ongoing effort to decline and implement a national vision for the future of food safety. 

Thank you, Mr. Chairman. 

[The prepared statement of Dr. Morris follows:] 

STATEMENT OF J. GLENN MORRIS, JR., MD, MPH *

Mr. Chairman, members of the Committee: it is a pleasure to have the opportunity to speak before you today to review the findings of the Report of the FDA 

Science Board’s Subcommittee on Science and Technology, on which I was a member. In the second part of my testimony, I would like to expand my remarks beyond 

the report to deal at a more general level with the ability of FDA to identify and 

control risks in our U.S. food supply. 

The Subcommittee’s report was entitled ‘‘FDA Science and Mission at Risk,’’ correctly emphasizing the critical nature of the current situation at FDA. In discussing 

food safety, the report concluded that ‘‘FDA does not have the capacity to ensure 

the safety of food for the Nation. Crisis management in FDA’s two food safety centers, Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), has drawn attention and resources away from FDA’s ability 

to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective routine surveillance, and conduct emergency outbreak investigation activities to protect the food supply.’’ ** I would strongly support these conclusions. 

As highlighted in the Subcommittee report, the current situation reflects decades 

of neglect of CFSAN and CVM’s resource needs. Since 2003, CFSAN’s workforce has 

declined from 950 FTE to 771 FTE, at a time when there have been increasing demands on the Agency. This includes demands brought on by an increasingly complex food supply, with rapidly expanding internationalization of markets, as well as 

increasing regulatory responsibilities related to new legislative mandates. Problems 

41 

***FDA Science and Mission at Risk. Estimated Resources Required for Implementation. Submitted by Gail Cassell, PhD, on behalf of the Subc0mmittee and its Members. February 25, 

2008. 

in both CFSAN and CVM have been further exacerbated by major outbreaks and 

recalls, which, of necessity, divert resources away from ‘‘routine’’ scientific, surveillance, and regulatory activities. 

In the absence of a clearly articulated vision for food safety in this country, it is 

difficult to come up with estimates for what it will cost to optimize the FDA food 

safety program. However, in response to a specific request of Representatives Dingell, Waxman, Stupak, and Pallone, our Subcommittee developed cost estimates for 

beginning the rebuilding process in the Agency; responses were submitted by Dr. 

Cassell on February 25 of this year. To summarize, our Subcommittee estimates 

called for an increase in the annual budget of food-related components of FDA of 

approximately $128 million for FY2009, with a cumulative increase of $755 million 

in annual budget by 2013. This figure includes $350 million to strengthen imports 

and $100 million to strengthen work with nutritional supplements, animal health, 

and cosmetics. Separate from this total is an additional $450 million cumulative 5- 

year increase in annual budget for enhancement of FDA Information Technology, an 

enhancement which is critical for FDA to be able to deal with the massive data 

flows necessary for its activities, including appropriate surveillance and food protection. ***

Food safety remains a critically important area of concern to the U.S. public. 

While attention always tends to focus on the latest outbreak, it is perhaps most concerning, from an epidemiologic standpoint, that reported incidence rates for the 

major foodborne pathogens (based on 2007 FoodNet data) have remained relatively 

constant during the past several years, with some actual increases. This follows initial declines in incidence rates seen after implementation of the USDA HACCP 

rules in 1995, suggesting that the impact of these landmark regulatory changes over 

a decade ago has ‘‘leveled off,’’ and underscoring the need for new and innovative 

approaches to protect the health of the American people. 

FDA, with responsibility for overseeing an estimated 80% of the Nation’s food supply, must take the major leadership role in the development and implementation of 

such new approaches. There is a broad consensus that the Agency must develop a 

proactive, risk-based (and science-based) preventive approach to food safety. Some 

of the key elements of such an approach have been articulated by the Agency, with 

the announcement of their Food Protection Plan. However, questions remain about 

implementation, and about the extent of the FDA vision. I would highlight three key 

issues: 

1) Development of a risk- and science-based approach to prevention requires 

science. Going beyond laboratory science, there is a need for high quality surveillance, both microbiologic and epidemiologic, to clearly identify and delineate problem areas. This, in turn, must be combined with a strong analytic capacity, both 

to guide the original data collection and to ‘‘make sense’’ of the data when they are 

collected. In this regard, many of the European countries (such as the Netherlands 

and Denmark) are well ahead of us, having in place well-designed surveillance systems that are used to regularly ‘‘tweak’’ the approaches and focus areas of the associated food safety regulatory agencies. Development of public health-based performance standards, which, long-term, are a critical element of a risk-based prevention 

system, requires an even higher level of sophistication in surveillance and analysis. 

Unfortunately, the capacity at FDA for such analysis is limited, and there is at best 

a clouded vision of what is needed for actual implementation of such systems. 

2) No matter how good the science, the Agency will not be able to move forward 

in the absence of an appropriate legislative mandate. In particular, if we are to develop performance standards, there must be a regulatory structure in place that can 

make appropriate use of such standards as part of a flexible, risk-based performance 

system. The legislation before this committee moves in this direction, and I applaud 

these efforts. 

3) And, as previously noted, there is a need for a substantial increase in the budgets for CFSAN and CVM. The estimates provided by our subcommittee are a starting point: the actual amounts necessary will almost certainly change, dependent on 

the extent of the Agency’s vision, and their approaches to implementation. In the 

long run, prevention is unquestionably cost-effective. However, we have a lot of rebuilding to do before we can begin to realize such cost savings. 

FDA science is at a critical juncture, with the negative impact of declining resources being felt perhaps most strongly in the food safety area. I would urge your 

committee to work to rebuild this resource base, and provide the necessary underVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
42 

lying legislative mandate, as part of an ongoing effort to define and implement a 

national vision for the future of food safety. 

Mr. STUPAK. Thank you, Doctor. 

Professor Taylor, your opening statement, please. 

STATEMENT OF MICHAEL R. TAYLOR, J.D., RESEARCH PROFESSOR OF HEALTH POLICY, THE GEORGE WASHINGTON 

UNIVERSITY, SCHOOL OF PUBLIC HEALTH AND HEALTH 

SERVICES 

Mr. TAYLOR. Mr. Chairman, Mr. Shimkus, members of the Subcommittee, I thank you for this opportunity to testify on the resource challenges facing FDA in implementing its Food Protection 

Plan. 

Americans have long looked to FDA as the focal point for food 

safety leadership in the United States and internationally but 

FDA’s ability to provide that leadership or even meet its basic food 

safety responsibilities is now badly impaired, in large part because 

society simply has not given FDA the tools it needs to do the job 

society expects it to do. These tools include adequate resources, the 

focus of today’s hearing, but also a modern statutory mandate and 

an institutional structure that is capable of national and international leadership on food safety. 

Mr. Chairman, the time for food safety reform has come, as you 

and others today have indicated, and as the result of recent events 

surrounding tomatoes so graphically remind us once again. I consider FDA’s new Food Protection Plan an important step toward 

the food safety reform we need. It marks a shift in strategic direction for FDA. The plan would move FDA from primarily reacting 

to food safety problems after they occur to taking an integrated 

systems approach that focuses on prevention and on the risk-based 

targeting of initiatives and resources to reduce the risk of 

foodborne illness. I think Dr. Acheson and his FDA colleagues deserve credit for this new direction. 

The issue now of course is implementation and substantial questions certainly remain. The Food Protection Plan contains eight 

broad initiatives and a total of 38 specific actions to strengthen 

FDA’s food safety program. In every case, these initiatives and actions involve either an entirely new effort by FDA or significant enhancement of something FDA is doing now. These proposed actions 

are all worthy, all should be pursued, as should other food safety 

initiatives that are not included in the plan such as increasing the 

overall frequency of FDA inspection and establishing and enforcing 

mandatory on-farm standards to ensure the safety of fresh produce. 

But the question is how. How is FDA going to do the work called 

for in its plan? FDA has issued its plan, as we have heard already 

this morning, at a time when its own Science Board has said that 

FDA lacks the resources and science base to do its food safety job, 

yet the plan itself does not address the resources needed to implement it or provide a timeline or priorities for implementation, and 

until earlier this week, the Administration had not proposed a 

budget for FDA that would even begin to address the Agency’s food 

safety funding crisis. 

43 

It is important to note that the total increase for food safety now 

proposed by the President for fiscal year 2009 is just a down payment on the more than doubling of FDA’s food budget that the 

Science Board and other experts say is needed over a 5-year period, 

and under the most optimistic scenario, when Congress will act on 

the 2009 appropriations, the new resources would first be available 

to FDA almost a year after the Food Protection Plan was issued. 

I think we all agree here today that FDA needs resources now. 

So given this harsh budget reality, what should FDA do? One of 

the first things to do, again, as others have said, is to lay out for 

the Congress and the public an implementation plan for the rebuilding and reform of its food safety program. This should include 

a detailed resource plan and clear priorities and timelines to implement the Food Protection Plan. Now, making such a plan is hard 

for an agency like FDA to do in the context of an annual budget 

process that does not lend itself to long-term planning, but the food 

safety transformation that is needed and that FDA is calling for demands a long-term effort and plan. Congress should require such 

an effort and plan from the Administration. In addition, I think 

FDA should identify some specific actions that it can take now to 

begin the shift from reaction to prevention and address some of today’s most pressing safety problems. In my written testimony, I 

suggest four such actions, which I will touch on briefly here. 

First, to begin the shift to risk-based priority setting and preventive risk management, FDA should identify the most significant 

food safety hazards within its jurisdiction and begin devising targeted strategies to reduce them. We can’t solve food safety problems without naming them first. Identification of the most significant hazards in the food supply can not only guide FDA’s actions 

but also inform the industry about risks that companies should be 

addressing in their own food safety plans whether or not those 

risks are being addressed immediately by FDA. 

Now, while we know enough to begin this kind of risk-based priority setting, FDA and industry alike have a pressing need for better and more timely information about the actual burden and root 

causes of human illness associated with foodborne pathogens and 

other hazards. FDA is dependent for this information, however, on 

the efforts of State and local health departments and the Centers 

for Disease Control and Prevention which have their own budget 

constraint, priorities, and limitations that have been obstacles to 

FDA getting the information it needs. 

Thus, the second immediate action I recommend is that FDA and 

the Department of Health and Human Services make it a high priority and take affirmative steps to improve the quantity, quality, 

and timeliness of the food safety epidemiology data available to 

FDA and others who need it to improve food safety. 

Third, I believe FDA should conduct a compliance and effectiveness audit of FDA’s seafood HACCP program. This program, established in 1996, foreshadowed the approaches to prevention and improved oversight of imports contained in the Food Protection Plan 

and in pending food safety legislation. It does this by requiring all 

seafood processors, domestic and foreign, to implement a preventive control plan and requires importers to take affirmative steps 

to ensure that the seafood they import was produced under condiVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00049 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
44 

*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). 

tions that meet the HACCP requirement. Because seafood safety is 

an important issue in its own right and because preventive control 

plans and strengthened industry responsibility for prevention are 

important elements of FDA’s new strategy, FDA should assess the 

overall effectiveness of the seafood HACCP role in preventing violations of U.S. food safety standards. It should identify legal, resource, and other constraints on the effectiveness of the rule and 

it should draw lessons for FDA’s development of preventive controls for other commodities in sectors of the food supply. FDA 

should learn from that experience. 

Finally, FDA should begin rulemaking now on the safety of fresh 

produce. Over a year ago, the United Fresh Produce Association 

and the Produce Marketing Association called on FDA to establish 

produce safety standards that are, and I quote, ‘‘federally mandated, risk-based and allow for commodity-specific regulation.’’ I 

agree that FDA should establish such standards and I think FDA 

should begin the rulemaking as soon as possible. 

With these actions, FDA can begin down the path of reform but 

Congress needs to do its part as well. FDA needs a stable and adequate resource base. It needs a modern food safety legislative mandate and it needs an organization structure that unifies and elevates the food safety program within HHS. Only then will FDA be 

equipped to do the food safety job that Americans expect and deserve. 

I thank you again, Mr. Chairman, and I look forward to questions. 

[The prepared statement of Mr. Taylor follows:] 

STATEMENT OF MICHAEL R. TAYLOR *

Mr. Chairman, Mr. Shimkus, members of the subcommittee, I appreciate this opportunity to testify on the resource challenges facing the Food and Drug Administration in implementing its Food Protection Plan. I applaud the subcommittee for 

tackling this important topic. 

INTRODUCTION

FDA has long been looked to as the 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 

ability to provide food safety leadership, or even meet its basic food safety responsibilities, is now badly impaired, in large part because society simply has not given 

FDA the tools it needs to the job society expects it to do. These tools includes a modern statutory mandate, an adequate and stable resource base, and an institutional 

structure capable of national and international leadership on food safety. 

The focus of this subcommittee, and the Committee on Energy and Commerce as 

a whole, on giving FDA the tools it needs to do food safety right is thus timely and 

important. 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. 

I consider FDA’s new Food Protection Plan an important step toward the food 

safety reform we need. It marks a shift in strategic direction for FDA, from primarily reacting to food safety problems after they occur to taking an integrated systems approach that focuses on prevention and on the risk-based targeting of initiaVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
45 

tives and resources to reduce the risk of foodborne illness. The FDA plan embodies 

many of the elements of a more effective and efficient food safety program that have 

been recommended over the last decade in a series of reports by the Government 

Accountability Office (GAO) and expert committees of the National Academy of 

Sciences (NAS). 

It is thus appropriate that Congress address FDA’s implementation of its Food 

Protection Plan, including the resources FDA will need to put the plan into practice. 

In my testimony, I will identify some specific activities that I believe deserve priority management attention and funding to begin the shift to a prevention paradigm, as well as address the scale of FDA’s resource needs for food safety in the 

long term. 

It is important, however, to consider the implementation of FDA’s Food Protection 

Plan and resource needs in the context of the broader statutory and organizational 

problems that must be addressed for FDA’s food safety program to succeed. I will 

thus note briefly how the obsolete food safety laws and fragmented organizational 

structure under which FDA operates stand in the way of full and effective implementation of the new plan and how these problems can be solved. 

FDA’S FOOD SAFETY FUNDING CRISIS

FDA’s Food Protection Plan is based on four ‘‘cross-cutting principles,’’ all of which 

are sound and all of which have significant resource implications. These are: 

1. Focus on risk over a product’s life cycle from production to consumption. 

2. Target resources to achieve maximum risk reduction. 

3. Address both unintentional and intentional contamination. 

4. Use science and modern technology. 

Building on these principles, the plan includes three core operational elements: 

(1) Preventing foodborne illness in the first place; (2) Intervening with risk-based 

FDA actions at critical points in the supply chain; and (3) Responding rapidly when 

contaminated food or feed is detected. Under these three core elements, FDA lays 

out eight broad new initiatives and a total of 38 specific actions to strengthen its 

food safety program. 

In every case, these initiatives and actions involve either an entirely new effort 

by FDA or a significant enhancement of something FDA is doing now. Under the 

critical first element of prevention, for example, the plan calls for FDA to, among 

other things, work with the food industry to promote corporate responsibility and 

best practices for food safety, increase FDA’s presence overseas, generate new data 

and develop new models for prioritizing risks, and develop and implement a research plan on sources of contamination and methods to prevent it. 

These activities are all worthy, as are the 34 other activities called for in the plan. 

All should be pursued. Moreover, the Agency should be pursuing food safety initiatives that are not included in the plan, such as increasing the overall frequency of 

FDA inspection and establishing and enforcing mandatory on-farm standards to ensure the safety of fresh produce. 

And legislation being developed by Chairman Dingell and other leaders in Congress would give FDA responsibility for implementing two major and needed new 

programs: the first involves mandatory adoption of preventive controls by all food 

facilities (domestic and foreign) that produce food for the U.S. market; the second 

makes importers accountable for assuring that foreign produced products meet U.S. 

standards. 

These efforts to strengthen FDA’s food safety program all require investment in 

such essential inputs to an effective program as increased scientific expertise and 

staffing levels, research and data collection to guide the new science- and risk-based 

preventive approach, new information management systems, and the operating 

funds needed to establish a leadership presence nationally and internationally. FDA 

has issued its Food Protection Plan and Congress is considering major new initiatives at a time, however, when the Agency lacks the resources to meet even its base 

food safety responsibilities, much less fund the worthy new initiatives. 

The seriousness of FDA’s food safety funding crisis was made crystal clear by the 

December 2007 report of the FDA Science Board, which found, starkly, that ‘‘FDA 

does not have the capacity to ensure the safety of food for the nation’’ and that 

‘‘[t]he Nation’s food supply is at risk.’’ The Science Board report said further that 

FDA’s food program lacks the resources ‘‘to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective 

routine surveillance, and conduct emergency outbreak investigation activities to protect the food supply.’’ The Science Board also noted ‘‘an appallingly low inspection 

rate’’ for FDA-regulated food facilities. 

46 

The Science Board is not alone in its concern about the current state of FDA’s 

resources for food safety. In its January 2008 testimony before this subcommittee, 

the GAO found that staffing levels and funding had ‘‘not kept pace with the Agency’s growing responsibilities.’’ GAO pointed out the Science Board findings that the 

number of domestic establishments and food import entries for which FDA is responsible has grown significantly; yet, from 2003 to 2006, staffing levels in FDA’s 

Center for Food Safety and Applied Nutrition (CFSAN) and in the field force responsible for food safety inspection and enforcement, actually declined, by 14 percent 

and 11.5 percent, respectively. Some 200,000 overseas food facilities are registered 

with FDA, but the Agency expects to conduct only 125 foreign food inspections this 

year. 

FDA’s funding constraints and downward trends provide a weak foundation on 

which to build a modern, science- and risk-based food safety program. Recognizing 

the need to re-build FDA’s scientific base and both headquarters and field capacity, 

the Science Board recommended in February 2008 substantial increases in FDA’s 

budget for overseeing the food supply, to be phased in over a 5-year period. FDA’s 

FY 2008 budget for overseeing the food supply (which includes resources for all of 

CFSAN, part of the Center for Veterinary Medicine, food-related field functions 

managed by the Office of Regulatory Affairs, and elements of the Office of the Commissioner and the National Center for Toxicological Research) is about $620 million. 

The Board recommended this be increased by $128 million in FY 2009, $283 million 

in FY 2010, $441 million in 2011, $598 million in 2012, and $755 million in 2013. 

This would bring FDA’s food-related budget in FY 2013 to $1.375 billion, which 

is not much more than the approximately $1.1 billion the President requested in his 

FY 2009 budget for USDA to oversee the safety of just 20 percent of the food supply. 

I agree that FDA needs resources on this scale to transform its food safety program 

from the current paradigm of reacting to problems to a paradigm of risk-based prevention. 

The President’s original FY 2009 budget requests for FDA included an increase 

of less than $43 million over the 2008 budget, which would just barely keep pace 

with FDA’s core inflation rate of 5.8%. This would mean keeping FDA’s actual operating capacity for food safety at essentially the same level that the Science Board 

found inadequate ‘‘to ensure the safety of food for the Nation.’’ 

I was pleased that on June 9, 2008, HHS Secretary Leavitt announced that the 

President’s FY 2009 budget request for FDA is being amended to add $275 million, 

of which $125 million would be available for food safety-related work, for a total FY 

2009 increase for food safety of $168 million, which exceeds the Science Board proposal. This is a good sign that the administration has recognized FDA’s food safety 

funding crisis. 

I am concerned, however, about when these additional funds, if agreed to by Congress, would become available. The earliest possibility, of course is October 1, 2008, 

the beginning of FY 2009, but that assumes Congress will pass FDA’s FY 2009 

budget on time, as opposed to a continuing resolution, which could extend FDA’s 

2008 funding level well into calendar year 2009. This would substantially delay implementation of the Food Protection Plan. 

Regardless of the prospects for the FY 2009 budget, FDA needs immediate budget 

help to get started with its prevention-oriented food safety strategy, as today’s ongoing and widespread outbreak of illness associated with salmonella-contaminated 

tomatoes so graphically demonstrates. I thus hope Congress will providing FDA additional food safety funds in the pending 2008 supplemental appropriations bill and 

that Congress will commit itself to a long-term funding plan for food safety at FDA, 

in keeping with the recommendations of the FDA Science Board. 

NEAR-TERM PRIORITIES TO IMPLEMENT FDA’S FOOD PROTECTION PLAN

The magnitude of the transformation that FDA’s Food Protection Plan envisions, 

coupled with inevitably finite management capacity and budgets, means that FDA 

must set priorities for how it invests its time and money to implement the plan, 

regardless of what action Congress takes on the 2008 supplemental and FDA’s FY 

2009 appropriation. 

To this end, the first thing FDA should do is determine the resources it needs 

to implement the Food Protection Plan and develop a detailed resource plan, including priorities, for their deployment. Clearly, based on the Science Board report, FDA 

needs to build its scientific base and information infrastructure for food safety, in 

addition to having the operating funds to take the many specific actions called for 

in the Food Protection Plan. The Plan was silent on resource needs but can be credible and effective only if accompanied by a realistic resource plan that Congress 

funds. 

47 

Beyond that, I’d like to suggest four specific actions that FDA can pursue now. 

I think these deserve high priority because they would both begin the shift to the 

prevention paradigm and address some of today’s most pressing food safety problems. Though all can be pursued under current law, they would also help lay the 

foundation for implementing new legislative mandates, such as contained in the discussion draft circulated by Chairman Dingell and on which Chairman Pallone held 

a hearing on April 24, 2008. 

BEGIN RISK-BASED PRIORITY SETTING AND RISK MANAGEMENT

The essential starting point for a risk-based, preventive approach to food safety 

is knowing what the most important risks are and systematically devising affirmative strategies to reduce them. FDA has not taken this approach in the past, but 

the Food Protection Plan’s initiatives 1.2 (Identify Food Vulnerabilities and Assess 

Risks) and 1.3 (Expand the Understanding and Use of Effective Mitigation Measures) signal FDA’s intention to move in this direction. 

This is not, however, a small undertaking. It involves: (1) identifying the most significant hazards in the food supply, meaning the specific combinations of foods and 

microbial or chemical contaminants that are likely to have the greatest adverse impact on public health; (2) prioritizing these hazards based on the magnitude of the 

potential risks they pose and the availability, likely effectiveness, and cost of measures to reduce the risks; and (3) developing risk reduction strategies for the highest 

priority hazards, including appropriate safety standards for each hazard, an inspection and enforcement plan to ensure the standards are met, and a plan to monitor 

the effectiveness of the strategy in reducing risk to the public. 

At the outset, FDA could, for example, identify the 20 most significant hazards 

within its jurisdiction and commit initially to devising prevention strategies for the 

top five. As this work progresses, FDA should regularly update its assessment of 

the hazards and, as appropriate, select additional hazards for priority risk management attention. 

In addition to guiding FDA’s priority setting and resource allocation, regular assessment and reporting by FDA on the most significant hazards in the food supply 

has the important advantage of informing the industry about risks companies 

should be addressing in their own food safety plans, whether or not those risks are 

being addressed immediately by FDA. 

Sufficient information exists today to begin risk-based priority setting and risk 

management. It is also clear that more complete information and better tools for 

analyzing and managing information will improve the efficiency and quality of the 

effort. FDA should, therefore, draw on its current knowledge and early experience 

with risk-based priority setting to map out a plan for obtaining and managing the 

information it needs. The plan should address institutional roles and responsibilities 

and resources for meeting FDA’s information needs. 

STRENGTHEN THE CONTRIBUTION OF FOOD SAFETY EPIDEMIOLOGY TO PREVENTION

One of FDA’s most critical information needs is better knowledge of the actual 

burden and root causes of human illness associated with foodborne pathogens and 

other hazards. Such information is essential to the risk-based prevention approach 

of the Food Protection Plan and to the individual efforts of food companies to prevent the risks arising in their operations. FDA should thus make it a high priority 

to improve the quantity, quality and timeliness of the food safety epidemiology data 

it receives. 

FDA is dependent for this information, however, primarily on the efforts of state 

and local health departments and the Centers for Disease Control and Prevention 

(CDC). These agencies operate under their own budget constraints and have other 

priorities and limitations that have been obstacles to FDA getting the information 

it needs in a timely fashion. The Food Protection Plan implicitly recognized this reality in calling for FDA to work with CDC to better attribute pathogens and illnesses to particular foods and identify where in ‘‘the production life cycle’’ the foods 

became contaminated. 

FDA should thus work through the Office of the Secretary of Health and Human 

Services to make the nation’s food safety epidemiology enterprise as responsive as 

possible to FDA’s information needs and the needs of other federal and state agencies and the food industry in their efforts to prevent foodborne illness. A focal point 

for leadership should be established within the Office of the Secretary to coordinate 

the efforts of FDA, USDA, CDC, and state and local health officials for this purpose, 

and FDA should have resources to finance specific enhancements in the way food 

safety epidemiological data are collected, analyzed and made available to better supVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00053 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
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port implementation of the risk-based prevention strategy embodied in the Food 

Protection Plan. 

CONDUCT A COMPLIANCE AND EFFECTIVENESS AUDIT OF FDA’S SEAFOOD HACCP 

PROGRAM

The seafood HACCP (Hazard Analysis and Critical Control Points) program that 

FDA established in 1996 foreshadowed the approaches to prevention and improved 

oversight of imports contained in the Food Protection Plan and pending food safety 

legislation. It requires all seafood processors, domestic and foreign, to prepare and 

implement a preventive control plan (specifically a HACCP plan), and it requires 

importers to take affirmative steps to ensure that the seafood they import was produced under conditions that meet the HACCP requirement. The HAACP rule’s provision for imports is particularly important since a large majority of the seafood consumed in the United States is imported. 

For resource reasons, FDA’s oversight of importers and inspection of foreign processing facilities is very limited, and, as seafood imports have grown, state and federal laboratories have documented a growing problem with chemical contaminants 

and antibiotic residues in farm-raised fish products, especially those coming from 

Asia. This raises questions about the reliability of the ‘‘affirmative steps’’ being 

taken by importers and the overall effectiveness of FDA oversight of seafood. Last 

year, FDA banned certain seafood imports from China. 

Because seafood safety is an important issue in its own right, and because preventive control plans and strengthened industry responsibility for prevention - through 

preventive control plans - are important elements of FDA’s new strategy, FDA 

should conduct a compliance and effectiveness study of the seafood HACCP program 

for both domestic and imported seafood. The purposes should be to: (1) assess compliance rates and the overall effectiveness of the seafood HACCP rule in preventing 

violations of U.S. food safety standards, (2) identify legal, resource and other constraints on the effectiveness of the seafood HACCP rule, and (3) draw lessons for 

FDA’s development of preventive control plans for other commodities and sectors of 

the food supply. 

BEGIN TARGETED RULEMAKING ON THE SAFETY OF FRESH PRODUCE

Over a year ago, the United Fresh Produce Association and the Produce Marketing Association called on FDA to establish produce safety standards that are 

‘‘federally mandated, risk-based and allow for commodity-specific regulation.’’ I 

agree FDA should establish such standards, and I believe FDA should begin the 

rulemaking process as soon as possible. 

It will be a challenge for FDA to develop workable, science-based standards that 

can evolve as the science of produce safety evolves. I also recognize that most of the 

pending food safety legislative proposals would mandate FDA establishment of 

produce safety standards. I support such legislation. Nevertheless, FDA should 

begin the process now with respect to one or more specific categories of produce— 

such as leafy greens and tomatoes—by gathering and analyzing the relevant scientific and technical information, beginning serious dialogue with experts in the 

produce industry and academia, and proposing regulatory options. 

In my view, the basic elements of the new standards should include a mandatory 

preventive control plan developed by each grower and tailored to local hazards and 

conditions, and, as appropriate and feasible, enforceable criteria or standards for 

key risk factors, such as microbial quality of irrigation, manure management, and 

control of livestock and other animal vectors for contamination. FDA should also 

evaluate the feasibility and reliability of utilizing state inspectors or private audit 

firms to review the sufficiency and implementation of these food safety plans and 

accompanying records on a regular basis and report their findings to FDA. 

By beginning the rulemaking process now, FDA will be acting to protect public 

health and will begin making the shift from reaction to prevention a reality for this 

important sector of the food supply. 

MODERNIZING FDA’S LEGISLATIVE MANDATE AND AUTHORITY

FDA’s Food Protection Plan is a good start, and solving FDA’s food safety funding 

crisis is essential, but it is equally essential that Congress modernize the food safety 

laws under which FDA operates. The basic provisions of the Federal Food, Drug, 

and Cosmetic Act under which FDA addresses the central public health problem of 

hazardous food contaminants and food imports were enacted in 1938, well before today’s understanding of the public health importance of microbial pathogens and the 

globalization of the food supply that continues to accelerate. 

49 

FDA’s core statutory tools consist primarily of a few broad definitions of ‘‘adulteration,’’ authority to inspect food facilities (but not, in general, food safety records), 

and a set of cumbersome-to-pursue judicial enforcement tools (seizure, injunction 

and criminal prosecution). FDA has made creative use of its authorities to set informal action levels and other de facto performance standards and adopt the seafood 

HAACP rule, but there is no mandate in the law, and thus no accountability for 

FDA to implement, a systematic science- and risk-based program to prevent 

foodborne illness. 

FDA should have such a mandate and, assuming adequate funding, should have 

clear accountability for carrying it out successfully. Otherwise, I question whether 

the new strategic direction presented in the Food Protection Plan will be sustained. 

ORGANIZATIONALLY UNIFYING AND ELEVATING THE FDA FOOD SAFETY PROGRAM

In addition to providing a modern statutory mandate and adequate resources, 

Congress should ensure that FDA has an organizational framework that enables the 

Agency to provide national and international leadership on food safety and to 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 Foods reflects the Agency’s awareness 

of the problem but does not solve it. I have great respect for Associate Commissioner 

David Acheson, but his 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. 

In my view, the solution to this structural weakness in FDA’s food safety plan 

is to unify the food-related components of FDA into a single organization and elevate 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. 

MAJOR POINTS

• I consider FDA’s new Food Protection Plan, with its integrated and risk-based 

systems approach to preventing illness, to be moving in the right direction toward 

the food safety reform we need. 

•FDA’s ability to implement the Food Protection Plan is seriously constrained by 

FDA’s food safety funding crisis. 

•From 2003 to 2006, FDA’s headquarters and field resources for food safety actually declined as the number of domestic establishments and food import entries 

grew significantly, leaving FDA with a weak foundation on which to build a modern, 

50 

science- and risk-based food safety program, as envisioned by the Food Protection 

Plan. • I support the FDA Science Board’s call for a long-term commitment to re-build 

FDA’s science base and food safety oversight capacity both at headquarters and in 

the field, as well as the Science Board’s specific recommendation to more than double the FDA food safety budget over a 5-year period from the current $620 million 

to $1.375 billion in 2013. •FDA should move forward now, however, to begin implementing the Food Protection Plan by developing a detailed a resource plan and pursuing the following high 

priority actions: 

o Risk-based priority setting and risk management for the most significant hazards; 

o Strengthening the contribution of food safety epidemiology to prevention; 

o Conducting a compliance and effectiveness audit of FDA’s seafood HACCP program; and 

o Targeted rulemaking on the safety of fresh produce. 

• In addition to providing FDA needed resources, Congress should modernize 

FDA’s food safety legislative mandate and direct that FDA’s food safety program be 

unified and elevated organizationally with the Department of Health and Human 

Services. 

Mr. STUPAK. Thank you, Professor Taylor. 

Dr. Levi, if you would, please, your opening statement. 

STATEMENT OF JEFFREY LEVI, PH.D., EXECUTIVE DIRECTOR, 

TRUST FOR AMERICA’S HEALTH 

Mr. LEVI. Thank you, Chairman Stupak, Ranking Member Shimkus, and members of the Subcommittee. I appreciate the opportunity to testify before you today. 

Trust for America’s Health is a nonprofit, nonpartisan organization dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority. We applaud the committee for continuing its thorough examination of the food safety functions at the FDA. 

This hearing could not be more timely. The current outbreak of 

salmonella associated with tomatoes is a perfect demonstration of 

our need for a modernized food safety system. It shouldn’t have 

taken so many people getting sick from salmonella poisoning for 

the government to start taking nationwide action to protect the 

American people, but it did. Not only has it taken us too long to 

recognize the threat, we are still struggling to find its source and 

we should have had systems in place to prevent it in the first place. 

A truly successful food safety system is one that we don’t read 

about in the newspapers because it is working so well, but as we 

have seen over the last week, instead we have a system that places 

the lives of Americans at risk, undermines overall public confidence 

in our food supply and threatens the economic stability of farmers. 

At the end of April, TFAH released a report entitled ‘‘Fixing Food 

Safety: Protecting America’s Food Supply from Farm to Fork.’’ Our 

report finds that food safety represents a significant public health 

threat. The food safety system is fragmented, depending on archaic 

laws, and chronically underfunded. The current system is reactive, 

not preventive, meaning we are wasting millions of dollars on responding to such threats rather than building proper controls into 

the production system. 

A major investment is necessary to prepare FDA’s food safety 

function for the 21st century marketplace. However, Congress 

should not provide the significant additional appropriations withVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00056 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
51 

out a clear strategy of how that money will be spent. We believe 

that the FDA’s Food Protection Plan is a good start. The plan represents a consensus document outlining broad concepts for modernizing the food safety system, and we are very pleased that the Administration has asked for an additional $125 million for the FDA’s 

food safety work. But increased funding must be sustained over 

time to allow for effective strategic planning, and before Congress 

acts on this request, we also believe it should know how the $125 

million request is crosswalked to the protection plan and what 

long-term funding will be needed to implement each element of the 

plan. 

TFAH has long been a watchdog for responsible government 

spending. While we advocate for a stronger investment in the public health system, we also expect accountability and transparency 

with respect to that investment. The FDA’s food safety system 

should be no different. Thus, we urge FDA to articulate the steps 

it will take to achieve each element of the plan including the personnel, laboratory capacity, information technology and research 

necessary to carry out each concept in the document. FDA should 

regularly report to Congress and the public with measurable benchmarks, data sharing and the resources necessary to move forward 

with its plan. 

Indeed, if the Administration is serious about modernizing the 

food safety system, each step of the implementation plan would 

carry with it a professional judgment number describing the appropriations necessary to achieve the goal, not just the legislative authority needed. We make this recommendation not simply for the 

sake of transparency but to strengthen FDA’s argument for additional funding. There are precedents for such an approach. For example, the Administration released a national strategy for pandemic influenza along with a request for $7 billion to carry out the 

strategy 2 years ago. The initial strategy articulated brought concepts and principles for pandemic preparedness just as the Food 

Protection Plan does, but as Congress moved forward with appropriating funding for pandemic influenza preparedness, the strategy 

was followed by an implementation plan which contains actionable 

steps from multiple federal departments including interim milestones against which Congress and the public can measure 

progress. 

In addition, several agencies within HHS are legislatively mandated to provide directly to Congress so-called bypass budgets that 

reflect their professional judgment of funding that is needed without having to receive OMB clearance. In fact, Dr. von Eschenbach 

had that experience with this process during his tenure at the National Cancer Institute. Each year, both the National Cancer Institute and the Office of AIDS Research provide Congress bypass 

budgets which include the resources necessary to maintain existing 

research and the money required to achieve specific expanded or 

new initiatives. The recent dance we saw leading to the formal request for an additional $125 million for the FDA’s food safety work 

was in a way an ad hoc version of this approach. The Subcommittee may want to consider enacting a regular bypass budget 

for the FDA as it embarks on its important process of modernization. 

52 

Just as policymakers are attempting to transform America’s 

healthcare system form a sick-care system to a well-care system, 

we must convert our food safety policy from reactive to a preventive system. The Federal Government can save money and lives by 

investing in technology, information networks and research. This 

effort will require leadership from Congress and the Administration to assure that both financial and human resources are devoted 

to this critical public health problem. The end result should be a 

safer food supply from farm to fork. 

I ask that my written testimony be included in the record, and 

I look forward to your questions. 

[The prepared statement of Mr. Levi follows:] 

STATEMENT OF JEFFREY LEVI, PH.D. 

SUMMARY

I am Dr. Jeffrey Levi, Executive Director of Trust for America’s Health (TFAH), 

a non-profit, non-partisan organization dedicated to saving lives by protecting the 

health of every community and working to make disease prevention a national priority. At the end of April, TFAH released a report entitled ‘‘Fixing Food Safety: Protecting America’s Food Supply from Farm-to-Fork’’. Our report finds the food safety 

system is fragmented, dependent on archaic laws, and chronically underfunded. The 

report can be found in its entirety at www.healthyamericans.org. 

Food safety represents a significant public health threat. According to FDA’s Web 

site, since January of this year alone, FDA has issued over 80 recalls, alerts, withdrawals, and warnings of unsafe or mislabeled food. These numbers are far too high, 

and major gaps in our Nation’s food safety system are to blame. The current food 

safety system is reactive, not preventive, meaning we are wasting millions of dollars 

on responding to such threats rather than building proper controls into the production system. Indeed, if we had a modernized food safety system focused on prevention, we would not need to be issuing this number of alerts and recalls. That said, 

given the disjointedness and underfunded nature of our food safety surveillance system, we cannot be sure that the alerts and recalls issued by FDA truly even reflect 

the extent of the problem today. 

Clearly, a profound investment is necessary to prepare FDA’s food safety function 

for the 21st Century marketplace. However, Congress should not provide significant 

additional appropriations without a clear strategy showing how that money will be 

spent. We agree that the FDA’s Food Protection Plan is a good start. However, the 

document lacks the specificity necessary to fund or to implement such a plan. Instead of broad principles, we urge FDA to articulate the steps it will take to achieve 

each element of the plan, including the personnel, laboratory capacity, information 

technology, and research necessary to carry out each concept in the document. FDA 

should regularly report to Congress and the public with measurable benchmarks, 

data sharing, and the resources necessary to move forward with its plan. This would 

not be unprecedented for this Administration: its National Strategy for Pandemic 

Influenza: Implementation Plan contains actionable steps for multiple federal departments to take to achieve an adequate level of preparedness, including interim 

milestones against which progress can be measured. 

In addition to lacking detail, the Food Protection Plan remains abstract because 

there is no budget request associated with it. Each step of the implementation plan 

should carry with it a professional judgment number describing the appropriations 

necessary to achieve the goal. This would be similar to the bypass budgets of the 

National Cancer Institute and the NIH Office of AIDS Research. 

Just as policymakers are attempting to transform America’s healthcare system 

from a sick-care system to a well-care system, we must convert our food safety policies from a reactive to a preventive system. The Federal Government can save 

money and lives by investing in technology, information networks, and research. 

This effort will require leadership from Congress and the Administration to assure 

that both financial and human resources are devoted to this critical public health 

problem. The end result should be a safer food supply from farm to fork. 

53 

TESTIMONY

I am Dr. Jeffrey Levi, Executive Director of Trust for America’s Health (TFAH). 

Trust for America’s Health is a non-profit, non-partisan organization dedicated to 

saving lives by protecting the health of every community and working to make disease prevention a national priority. We applaud the Committee for continuing its 

thorough examination of the food safety functions at the Food and Drug Administration (FDA). At the end of April, TFAH released a report entitled ‘‘Fixing Food Safety: Protecting America’s Food Supply from Farm-to-Fork’’. As we know, recent tragedies have shed a light on glaring gaps in the Nation’s federal food safety system, 

but we now have the opportunity to build a better system for the future. My comments today will discuss the report’s findings as well as additional concerns we have 

with the current food safety system. The report can be found in its entirety at 

www.healthyamericans.org. 

Food safety represents a significant public health threat. One in four Americans is sickened by foodborne disease each year, and an estimated $44 billion is lost each 

year in medical and lost productivity costs. According to FDA’s website, since January of this year alone, FDA has issued over 80 recalls, alerts, withdrawals, and 

warnings of unsafe or mislabeled food. These numbers are far too high, and major 

gaps in our Nation’s food safety system are to blame. Indeed, if we had a modernized food safety system focused on prevention, we would not need to be issuing this 

number of alerts and recalls. That said, given the disjointedness and underfunded 

nature of our food safety surveillance system, we cannot be sure that the alerts and 

recalls issued by FDA truly even reflect the extent of the problem today. 

The public is deeply concerned about this issue. A 2007 public opinion poll conducted on behalf of TFAH found that 67 percent of Americans are worried about 

food safety. This number ranked above the threat of pandemic flu or natural disasters, illustrating just how strongly food safety truly touches every American. The 

food supply is vulnerable to a variety of pathogens, toxic metals, and other pollutants, product tampering, and emerging diseases. The current food safety system is 

reactive, not preventive, meaning we are wasting millions of dollars on responding 

to such threats rather than building proper controls into the production system. 

TFAH’s report identifies several problems with the government’s food safety system: inadequate federal leadership, coordination and resources; outdated laws and 

policies; and inadequate Federal, State and local collaboration. 

INADEQUATE FEDERAL LEADERSHIP, COORDINATION AND RESOURCES

The Federal food safety system is fragmented. According to the 2007 GAO report, 

there are 15 agencies collectively administering over 30 laws. Even among lead 

agencies, the government’s ability to prevent illness is undermined by the segmented responsibilities among many agencies, which often use differing regulatory 

approaches. No agency has statutory authority to forge an integrated strategy, and 

no agency or person has final authority over food safety. This results in overlapping 

inspections by FDA and USDA’s Food Safety and Inspection Service (FSIS) and food 

companies having to follow different regulations from each agency within the same 

plant. Clearly, FDA could use its resources better through increased collaboration 

and coordination with USDA. 

The current system is not just fragmented, but also experiences misaligned priorities and resources. FDA regulates 80 percent of the U.S. food supply, and an estimated 85 percent of known foodborne outbreaks are associated with FDA-regulated 

food. However, FDA receives less than 40 percent of the overall federal dollars devoted to food safety programs. In addition, funding for food safety programs at FDA 

and FSIS has barely kept pace with inflation. Even as these agencies must take on 

new challenges, such as those laid out in the FDA Food Protection Plan, they are 

barely able to pay for their existing food safety system. 

Furthermore, within both FDA and USDA, food safety is not the top priority. At 

FDA, pharmaceuticals and medical devices—the ‘‘drug’’ part of the Food and Drug 

Administration—receive priority attention. At USDA the focus is on promoting U.S. 

farm commodities abroad and helping farmers and agribusiness at home. 

We agree with the Science Board’s assessment that weaknesses in the FDA’s food 

safety function are directly related to its inadequate resources. Trust for America’s 

Health recommends at least doubling FDA’s food budget in real terms over the next 

5 years. The need for additional appropriations has been echoed by the National 

Academy of Sciences Institute of Medicine, the Government Accountability Office, 

and the Health and Human Services Inspector General. TFAH believes FDA needs 

a consistent source of funding to keep up with its mandate. We were pleased to see 

additional food safety money in the Senate’s supplemental, but appropriators should 

54 

bear in mind that increased funding should be rolled into baseline appropriations 

in FY 2010, rather than returning to previous funding levels. It is nearly impossible 

for the Agency to adequately plan and hire full-time staff if it is unclear whether 

money will be stable from year to year. 

In addition to funding, FDA needs to ramp up its personnel levels. According to 

former FDA Commissioner Mark McClellan, the President’s FY 2009 budget ‘‘does 

little to make up for the steady loss of staffing that the Agency has endured for the 

past decade.’’ We were pleased that FDA recently announced plans to hire 1,300 

science and medical staff, including 600 new positions, and we are eager to see how 

they are used to implement the FDA’s Food Protection Plan. However, given the 

broad consensus among experts who doubt the FDA’s ability to fulfill even its existing food safety mandate given current funding levels, we are reluctant to view this 

announcement as an end to the Agency’s problems. 

OUTDATED LAWS AND POLICIES

Increased funding for food safety is a start. But our report notes that the Federal 

Government is spending existing funds on outdated, inefficient practices. TFAH has 

long been an advocate for accountability within the public health system, and the 

federal food safety system is an example of misallocated funds due to adherence to 

an archaic framework. The USDA’s FSIS spends most of its resources visually inspecting every beef, pork, and poultry carcass in ways not too different from practices used 100 years ago, although the health of animals has greatly improved and 

most foodborne illnesses cannot be detected visually. Likewise, FDA’s food safety 

statutes date to 1906 and 1938. FDA’s law developed a system that is reactive to 

problems prevalent in early 20th Century food system, such as adulteration and 

misbranding. It empowers FDA primarily to act only after food safety problems 

occur. Our report finds that Congress has not provided the Agency with a modern, public 

health mandate to prevent foodborne illness; has not updated the Agency’s legal 

tools to meet the challenges of a high-tech, globalized food supply; nor has it provided the funding stream necessary to carry out research and inspection. 

America’s food supply faces new threats, and the safety system needs to reflect 

changes in the market. A 21st Century production and distribution system means 

that instead of a single contaminated head of lettuce affecting one family, that lettuce may be divided among a dozen prepackaged bags of salad shipped across the 

country. The centralization of agribusiness means there is significant contact between livestock and crops, which can lead to a single infected product causing pervasive damage. 

Deliberate contamination of the food supply for economic or terroristic reasons 

could also have a widespread, devastating impact on the Nation before the Federal 

Government even has time to react. We saw this in 2007 when imported pet food 

killed thousands of cats and dogs in the United States after being deliberately contaminated with melamine for economic profits. It is not science fiction to believe 

such action could occur again, with malicious intent. The Administration’s Homeland Security Presidential Directive 9 called for a coordinated national approach to 

deliberate threats to the food supply. HSPD–9 tasked the Department of Homeland 

Security to work with USDA, HHS, and EPA to coordinate a national response, but 

FDA has not received additional funding and USDA has received only additional 

$150 million. FDA needs more authority to implement measures against 

agroterrorism, including increased surveillance. 

INADEQUATE FEDERAL, STATE, AND LOCAL COLLABORATION

The existing governmental food safety system is decentralized, so state and local 

departments have authority that extends beyond federal jurisdiction. State and local 

health departments are the frontlines in the fight against unsafe food, as they investigate outbreaks, inspect restaurants, and coordinate communication up the chain. 

The vast majority of foodborne diseases are detected and investigated at the local 

level. Yet, the capacity of states to conduct appropriate safety surveillance and communicate that back to the Federal Government varies dramatically. Federal support 

(through the CDC) for such critical state activities is minimal. In a 21st Century 

food economy, outbreaks are not limited to one state; early detection of what could 

become a national problem is dependent on the capacity of the state with the weakest surveillance system. 

The relationship between Federal and State regulators is also not well defined, 

so jurisdiction and communication may be hindered. In addition to a lack of resources to quickly respond to outbreaks, there are no mandatory national standards 

for state and local governments to adopt in their communities. Instead, most states 

55 

adhere to voluntary standards such as the FDA’s Food Code, a model to assist governments in regulating the retail and food service industry. Although these standards are updated every other year, the vast majority of states have not adopted the 

most recent guidelines. The Voluntary National Retail Food Regulatory Program is 

another voluntary guideline for states to develop science-based measures of performance that will lead to more effective and uniform regulation of the food industry. 

Only 12 states have fully enrolled and achieved verification by external evaluators 

of the program. TFAH recommends creating uniform standards and practices across 

the federal, state, and local levels. States should be encouraged and incentivized to 

adopt and comply with uniform standards of the most recent FDA Food Code and 

the National Retail Food Regulatory Program. 

The systems used to monitor food disease outbreaks are also a patchwork of various government agencies at the federal, state, and local level working largely independently with limited coordination. Government surveillance, or detection of 

foodborne diseases, exists alongside food safety practitioners from the private sector, 

public interest groups, and academia. As Michael Taylor, former FDA Deputy Commissioner for Policy, addressed in his recent report on the Food Safety Information 

Infrastructure, these data sources remain isolated, without the legal, logistical, or 

cultural means to share information. At a recent congressional briefing hosted by 

TFAH, Dr. Tim Jones, state epidemiologist for Tennessee, noted that communication 

of hazards is highly variable among states, which often lack the personnel, technology, and data sharing systems to react quickly to detected outbreaks. TFAH contends that a person’s protection from disease should not depend on where he or she 

lives, and the fragmented food surveillance system is an example of such disparity. 

OPPORTUNITIES FOR MODERNIZATION

TFAH believes that we need a comprehensive approach to update and strengthen 

the Federal food safety system. The institution of Hazard Analysis and Critical Control Points (HACCP) is a good example of a promising approach to modernization 

within FDA and FSIS. Such a system first requires companies to identify potential 

hazards and critical control points throughout the production process, and then establish preventive procedures to monitor and ensure those hazards are avoided. 

However, FDA has not implemented HACCP across the food production chain, and 

where it exists in many cases it is only on a voluntary basis. Widespread implementation of HACCP and other preventive systems could save money in the long run 

by identifying potential problems before they occur. 

Imported food presents a new, troubling frontier for food safety. Fifteen percent 

of the food we eat is imported, including 60 percent of produce and 75 percent of 

seafood. Yet, only 1 percent of shipments are inspected by the FDA each year. The 

Administration released the Import Safety Action Plan and the Food Protection Plan 

in November. These plans called for working with foreign governments to ensure 

compliance with U.S. safety standards, but as Mr. Taylor notes in our report, the 

FDA does not have the resources to ensure the safety of imports without harnessing 

the expertise and resources of the private sector. In addition to providing resources 

for implementing the Import Safety Action Plan and the Food Protection Plan, Congress should require food importers to be legally accountable for assuring that foreign producers are shipping goods to the U.S. that meet U.S. food safety standards. 

As mentioned earlier, surveillance is a key component to identifying foodborne 

outbreaks. Congress can support this mission through removing legal restrictions on 

data sharing, mandating coordinated data collection among government agencies, 

and improving the collection of and accessibility to data. Data collection and improving networks among all actors, including private sector and academia, is critical to 

mitigate the effects of unsafe food. TFAH recommends government food safety officials and food companies should be given the tools to keep track of information 

about disease outbreaks in humans, plants, and animals and results of food inspections so they can quickly detect and contain problems. CDC’s surveillance program 

should also be able to function in a way that not only monitors outbreaks and investigates preventive strategies, but also provides accountability to gauge how well 

U.S. food safety systems are working. 

In order to develop a dynamic, evolving food safety system, greater investment in 

research is a prerequisite. Ongoing research is needed to identify emerging threats 

and up-to-date ways to contain them, as well as to rank relative risks and the 

health impacts of those hazards. The FDA Food Protection Plan echoes the need to 

strengthen the Agency’s research capacity, but the document does not clarify how 

it will implement the mission or how it will work with other federal agencies to coordinate a research agenda. As the Science Board report tells us, FDA does not have 

the funding to conduct its existing research requirements and lacks a clear vision 

56 

of new areas of research needed. Funding and planning are vital to carrying out a 

modern research program, which should serve as a basis for FDA’s regulatory 

framework. 

PLANNING AND RESOURCES

Clearly, a profound investment is necessary to prepare FDA’s food safety function 

for the 21st Century marketplace. However, Congress should not provide significant 

additional appropriations without a clear strategy of how that money will be spent. 

We agree that the Food Protection Plan is a good start. The Plan represents a consensus document, outlining broad concepts for modernizing the food safety system. 

However, it lacks the specificity necessary to fund or to implement such a plan. 

TFAH has long been a watchdog for responsible government spending. While we advocate for a stronger investment in the public health system, all of our reports insist 

on accountability and transparency with respect to that investment. FDA’s food 

safety system should be no different. Before Congress appropriates significant funds 

to modernize the food regulatory system, FDA must demonstrate exactly how it intends to spend those funds. Instead of broad principles, we urge FDA to articulate 

the steps it will take to achieve each element of the plan, including the personnel, 

laboratory capacity, information technology, and research necessary to carry out 

each concept in the document. FDA should regularly report to Congress and the 

public with measurable benchmarks, data sharing, and the resources necessary to 

move forward with its plan. 

In addition to lacking detail, the Food Protection Plan remains abstract because 

there is no budget request associated with it. If the Administration is serious about 

modernizing the food safety system, each step of the implementation plan should 

carry with it a professional judgment number describing the appropriations necessary to achieve the goal. We make this recommendation not simply for the sake 

of transparency, but to strengthen FDA’s argument for additional funding. As an example, the Administration released a National Strategy for Pandemic Influenza 

along with a request for $7 billion to carry out the strategy. The initial strategy articulated broad concepts and principles for pandemic preparedness, just as the Food 

Protection Plan does. But as Congress moved forward with appropriating funding 

for pandemic influenza preparedness, the strategy was followed by an Implementation Plan, which contains actionable steps for multiple federal departments to take 

to achieve an adequate level of preparedness, including interim milestones against 

which Congress and the public could measure progress. The implementation plan 

gave credence to the President’s funding request. 

Developing a comprehensive strategic plan with a corresponding budget request 

is not a novel concept. Several agencies within HHS are legislatively mandated to 

provide Congress with so-called by-pass budgets that reflect their professional judgment of funding that is needed without having to receive OMB clearance. In fact, 

Dr. von Eschenbach had experience with this process during his tenure with National Cancer Institute. Each year, both the National Cancer Institute and the Office of AIDS Research provide Congress and the President with their annual budgets, which include the resources necessary to maintain existing research and the 

money required to achieve specific expanded or new initiatives. The Subcommittee 

may want to consider enacting a similar mandate for the FDA as it embarks on this 

important process of modernization. 

CONCLUSION

Just as policymakers are attempting to transform America’s healthcare system 

from a sick-care system to a well-care system, we must convert our food safety policies from a reactive to a preventive system. The Federal Government can save 

money and lives by investing in technology, information networks, and research. 

This effort will require leadership from Congress and the Administration to assure 

that both financial and human resources are devoted to this critical public health 

problem. The end result should be a safer food supply from farm to fork. 

Mr. STUPAK. Thank you, Doctor. Your written statement, as all 

written statements, will be part of the record. 

I will begin with questions. We will go 5 minutes so we can move 

the rounds along here. Let me ask you this question. We have all 

touched on it today, the tomato, salmonella in the tomatoes. If you 

take a look at the timeline, mid-April, people started getting sick 

57 

from tomatoes. On June 3, the FDA issued its first warning in the 

States of New Mexico and Florida for certain types of tomatoes. On 

June 7, the FDA put out its warning nationwide for certain types 

of tomatoes. And we know it is the first year anniversary of the 

FDA’s Tomato Safety Initiative. Why hasn’t this initiative worked 

to stop the salmonella in tomatoes if we knew it was a problem, 

we implemented a plan a year ago, but here we are, a year later, 

having nationwide warning? Anyone care to tackle that? Professor 

Taylor. 

Mr. TAYLOR. Well, I will put the answer to that question in an 

even broader context. We knew 10 years ago that there was a significant increase in outbreaks associated with fresh produce. FDA 

put in place a so-called guidance for good agricultural practices, 

which was a worthy thing to do at the time. It reflected what was 

known at the time but it was very broad guidance. It said pay attention to microbial quality of the water but there were no standards or criteria for what is appropriate microbial quality of the 

water that is used in irrigation and other risk factors were addressed only in these very broad sort of terms. A properly funded 

and mandated FDA would have had a leadership responsibility and 

the resources behind it to drive the research and develop the criteria, to set the standards that should have been in place long ago 

to ensure the safe production of tomatoes and other fresh produce 

on the farm. So I think the tomato safety plan was another effort 

with the best information available but it was not linked with the 

focused research base and the scientific knowledge needed, coupled 

with an actual regulatory intervention to create accountability for 

implementing these control measures. 

Mr. STUPAK. But this safety initiative would also have to be initiated not just here in this country but also like Mexico and other 

places where we import tomatoes, would it not? It doesn’t make 

any sense to have a tomato initiative just confined to the domestically produced crop but would have to be for imports too, would it 

not? 

Mr. TAYLOR. Absolutely. I think there is wide agreement that as 

we put in preventive control requirements and measure domestically, we have to make importers accountable for ensuring that the 

imported product meets those standards. It should be a condition 

of entry into the United States because it demonstrated compliance 

with the same preventive control measures in foreign fields as we 

would expect to have in U.S. fields. 

Mr. STUPAK. Dr. Morris? 

Dr. MORRIS. Just to add, again, I think what the tomato outbreak points out is the difficulty of being purely in a reactive mode, 

and I am highly sympathetic with FDA, having been in similar positions in government. It is extremely difficult to do these tracebacks, but having said that, the whole point of this is to put in 

place a system where we don’t have to do the trace-backs. 

Mr. STUPAK. Sure. Wouldn’t the year-ago tomato initiative make 

us proactive or preventive, not reactive? I mean, reactive, we still 

don’t even know where the tomatoes are coming from. 

Dr. MORRIS. Exactly. 

Mr. STUPAK. Let me ask you this. This is the report we have all 

referred to, the Food Protection Plan, put forth by the FDA last NoVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00063 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
58 

vember, and then the request for $50 million to implement it. Dr. 

Levi, I take it that the newest request that came Monday, which 

was $125 million, you would not give even the $125 million based 

on this report. What else would you look for before Congress would 

just throw money at a situation? 

Mr. LEVI. Well, I would be loathe to say don’t give them the 

money. I would say that there is enough opportunity in the appropriations process to do a back-and-forth to get a lot more specificity 

associated with the spending of this money but—— 

Mr. STUPAK. What specificity would you like to see in that report? 

Mr. LEVI. I would want to see dollar figures associated with each 

element of the report, and I think we have heard from others here 

that even that money, the $125 million, may not be sufficient, but 

we can’t really judge what is missing and what we are going to get 

for that $125 million until that request is crosswalked to the protection plan. If the Administration says this money is to implement 

the plan, they should at least be able to tell us what parts of the 

plan we are buying with $125 million. 

Mr. STUPAK. Professor Taylor, we will go right down the line. 

Mr. TAYLOR. I just want to add that it is a matter of priorities 

and sequence of activities. Those 38 very significant actions can’t 

all be done at once. They shouldn’t all be done at once. FDA should 

identify what are the priority things needed to get this process 

going. I suggested a few in my testimony. There may be better ones 

that that but it is a matter of priorities and sequence. 

Mr. STUPAK. Dr. Morris? 

Dr. MORRIS. And I would also, as I noted in my testimony, the $128 estimate from the Science Board subcommittee is a very loose 

estimate. I mean, essentially it is a starting point and a ballpark 

figure, and there is clearly a need to link this with specifics because that is going to drive what the real costs are. 

Mr. STUPAK. Dr. Cassell? 

Ms. CASSELL. I don’t have anything to add. I like Glenn said 

it—— 

Mr. STUPAK. OK. Now, on that $125 million they asked for on 

Monday night, that does not include any IT, which would certainly 

help us try to figure out where tomatoes are coming from. Ms. 

Shames, would you like to comment on that? What would you like 

to see? And GAO has been very critical of it. What would you like 

to see in that Food Protection Plan? 

Ms. SHAMES. The Food Protection Plan really is the rudiments of 

a strategic plan, and there is a statutory precedent for the sort of 

information that Congress has asked for from executive agencies to 

do the oversight that is needed. Information should include the 

long-term goals, which are laid out in terms of the core elements 

in the Food Protection Plan. But then beyond that, we would want 

those long-term goals to be segmented into interim goals and with 

those interim goals to know exactly what the associated resources 

are in terms of dollars, in terms of people, in terms of technology. 

Mr. STUPAK. You said long-term goals. This report, I get the impression there is no limit, no time. What kind of plan—— 

Ms. SHAMES. There is no—— 

Mr. STUPAK. A 1-year, 3-year, 5-year plan? What should it be? 

59 

Ms. SHAMES. There is no stated time frame to the plan. You are 

right about that. We have been told that it is envisioned to be a 

5-year plan. 

Mr. STUPAK. My time is up. I will turn to Mr. Shimkus. 

Mr. SHIMKUS. Thank you. 

Mr. STUPAK. Wait a minute. Dr. Cassell had her hand up. If it 

is a 5-year plan, we should at least have 5 years worth of data, 

should we not, and budget requests, Dr. Cassell? 

Ms. CASSELL. I personally would like to know more about the 

technologies that will be applied and the plan to ensure that in fact 

there is professional development of those individuals responsible 

for food safety, getting back to our original report, so that we can 

always be sure they are on the cutting edge and are aware of 

emerging new technologies. 

Mr. STUPAK. Thank you. 

Mr. Shimkus, please. 

Mr. SHIMKUS. Thank you, Mr. Chairman. Reforming a federal 

bureaucracy is a difficult challenge. It doesn’t have the market 

forces of bankruptcy and so that is an inherent challenge. 

I want to focus on some broad issues. You know, this is really 

a lot of specificity that to the layman is touch. That is why you are 

here and I appreciate it. All you mentioned a focus on risk-based 

approach. I think everyone mentioned the importance of doing that. 

We are in discussions on an FDA authorization bill, and there is 

still not acceptance that a risk-based approach is an appropriate 

way to go because I think there are feelings from some of my 

friends on the other side that this means going soft on industry. 

Can some of you chime in on that? I don’t believe it is true. I think 

it is a cost-benefit way of identifying problems, but just respond to 

that concern. Go ahead, sir. 

Mr. TAYLOR. I think it is very important to distinguish between 

the industry role in food safety and the government role, and when 

we talk about a risk-based approach, it is not about going soft on 

industry’s duty to ensure that every product that they market 

meets safety standards. And in fact, the proposals to require every 

food facility to have a preventive control plan stands for the idea 

that every company should be sure that they have got a plan in 

place to meet standards. Regardless of whether it is a high-risk 

product or a low-risk product, everybody should have a preventive 

food safety plan. When we use the term risk-based effort by the 

government, we are really talking about how the government can 

then deploy its resources, whether they are inspection resources or 

research or new rulemaking, standard setting. ow does the government deploy its inherently finite resources to address the most significant hazards in the food supply and mount the preventive initiative that do often require government initiatives. So it is risk 

based in terms of priority setting and use of government resources 

and targeting those significant hazards that are out there that we 

know about and that require a concerted effort to address through 

research, technological innovation, standard setting, education, 

whatever the appropriate tool might be. 

Mr. SHIMKUS. Anyone else want to—Ms. Shames. 

Ms. SHAMES. The government and FDA in particular can only afford a risk-based approach to its inspections. For example, if FDA 

60 

were to inspect every single domestic facility dealing with food, it 

would come to over $500 million. That figure is astounding. If FDA 

were to inspect every foreign facility, it would come to over $3 billion. 

Mr. SHIMKUS. I have tried to raise this in some of my discussions. If you have good actors who have zero defects across their 

whole product line, it doesn’t make sense to be in there twice a 

year and focus those resources and maybe go to once a year but 

that is kind of—Dr. Morris, do you want to add something? 

Dr. MORRIS. Just to further expand on this idea, one cannot inspect safety into a product, and you can’t inspect every single thing 

that goes by, every single apple. Again, the concept is to create a 

preventive system that minimizes the risk, puts in place multiple 

hurdles to minimize risk. But again, you come back to, what is the 

government’s role, and the government needs to target its role so 

that it hits the areas where there is the greatest risk of occurrence 

of human disease. And again, this is where some of the difficulties 

arise and that ultimately our goal is to keep people from getting 

sick, but to figure out how to put in place a plan that minimizes 

the risk for human disease is difficult and it requires some science, 

it requires some work, and it requires some resources to be able to 

do that, and that is where the vision gets cloudy. To be able to really do what needs to be done to appropriately prioritize resources, 

government resources, to maximize the impact of government to be 

able, you know, to get the safest possible product. 

Mr. SHIMKUS. Because we are a reactive body, especially even on 

a 1-year spending budgetary cycle, would a 2-year budgetary cycle 

be helpful in this whole reform debate? I will just allow anybody 

that wants to—Dr. Taylor. 

Mr. TAYLOR. Anything that can be done to extend the planning 

horizon and planning of use of resources is to the good, so—— 

Mr. SHIMKUS. Yes, the idea is, you pass a budget for 2 years, and 

the second year you use to do oversight and investigation and do 

evaluation. If you are every year fighting on just the spending 

end—because I look at this. You look at, this is a chicken and the 

egg debate. We have a plan, then we have to fund, then we have 

to execute, then we have to evaluate through the execution process 

and then we have to revise, and you can’t do that if you are limited 

by a 1-year budgetary cycle. 

Mr. LEVI. I also think it is important to keep in mind that a lot 

of the problem at FDA is personnel, that they need more scientists 

to do the work, and if there is not predictability for funding, then 

it is very hard to recruit scientists to come and work there because 

they don’t know whether they are going to have a job from one year 

to the next, and I think that is also the challenge with focusing on 

a supplemental. We should get as much money as we can into the 

supplemental but that is even more unpredictable, especially if for 

fiscal 2009 we are at least starting probably all predictions are for 

a continuing resolution and that creates even more instability and 

uncertainty and makes the hiring process that much more difficult. 

Mr. SHIMKUS. And I appreciate that comment, because I did have 

a question on this whole staffing issue and where it is good to get 

the additional money but there is uncertainty there, and Mr. 

61 

Chairman, that is all I have because you answered the question, 

Dr. Levi. Thank you. 

Mr. STUPAK. Thank you, Mr. Shimkus. 

Ms. DeGette for questions, please. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

Well, I have been looking at this plan, and it has happened before when I have looked at agency plans, it seems to me to be more 

of an idea than a plan, because in reading it, principles of the plan 

focus on risk, target resources, address both unintentional and deliberate contamination and use science. Well, I think this is what 

most of you are saying. We all support those hortatory goals but 

my question is, how do we get from point A to point B? So I am 

wondering if very briefly, starting with Ms. Shames, you could 

maybe give us two or three ideas, and one of them you have already testified, many of you, about, is put specific price tags on 

specific portions of the so-called plan. I am wondering if there are 

a couple of other specific suggestions you can make as to what we 

can do to make this dream a real plan. Ms. Shames? 

Ms. SHAMES. We testified in January that many of their proposals were consistent with the recommendations that GAO had 

made, so I would say that that would be a starting point in terms 

of FDA’s priorities to take. 

Ms. DEGETTE. The GAO recommendations? 

Ms. SHAMES. Exactly. 

Ms. DEGETTE. Thanks. 

Dr. Cassell? 

Ms. CASSELL. It all goes back to having the right people with the 

right skills, and quite honestly, I believe that the CFSAN and CVM 

have been so underfunded in the area of research, as I pointed out, 

now for over a decade as well as their overall funding. Personally, 

I don’t think they have the right set of people with the right skills 

to maybe—— 

Ms. DEGETTE. And what could we do to help that to happen? 

Ms. CASSELL. I think to immediately request the supplemental 

funding and then hold the feet to the fire in terms of getting more 

specificity around the plan and to also guard against the possibility 

that you wouldn’t have recurring funding so that you will have difficulty recruiting the individuals. 

Ms. DEGETTE. Dr. Morris? 

Dr. MORRIS. I would strongly concur with Dr. Cassell’s statement. I would also add though that one also needs the expertise 

at the top levels of management to really understand how to approach these problems. If you really want to get concrete with some 

of this, to my mind the top priority is to identify what the problem 

areas are. We have to have good surveillance. Right at the moment, 

FDA surveillance is woefully inadequate. We don’t even know what 

our problems are out there. We can’t really identify what the major 

products are that are creating problems, where the pathogens are. 

There is just—there is a significant lack of knowledge, and in particular when we compare our knowledge base with the knowledge 

base of what is present in Europe, for example—— 

Ms. DEGETTE. Dr. Morris, I am sorry to cut you off. I have a very 

limited amount of time. 

Dr. MORRIS. Certainly. 

62 

Ms. DEGETTE. And now we have a vote on the Floor. 

Professor Taylor? 

Mr. TAYLOR. I can be quick because I agree on the capacity 

points and also very much agree on the need for information, to 

know what the problems are and to know what the preventive solutions are, but then it is a matter of acting, and again, I think there 

are hazards out there, whether it is imported seafood or produce, 

where it is time to act to put in place preventive controls. Congress 

can legislate to make that easier. FDA has some authority. We 

should get action on that front. 

Ms. DEGETTE. Thank you. 

Doctor, is it Levi or Levi? 

Mr. LEVI. Levi. 

Ms. DEGETTE. Levi. 

Mr. LEVI. And I will be brief as well. I agree with my colleagues. 

Long-term funding for people, for technology, and give the FDA the 

authority that we want them to have so that they can really create 

a modernized system. 

Ms. DEGETTE. Now, Dr. Levi, one of the things that the FDA has 

said is they can’t talk about a multi-year plan because of statutory 

limitations, but in your testimony, you noted that in your oral and 

written testimony you said that we did exactly that with the pandemic flu plan. Do you see any barriers in doing it with food safety 

as well? 

Mr. LEVI. Absolutely not. I mean, it is a policy choice on the part 

of the Administration to project out into the future. They were able 

to do it for pandemic flu, and Congress actually did it in a way that 

provided almost $7 billion so that it could be carried out as milestones were reached. It is a very similar scientific challenge that 

you can only move just so fast because you have certain milestones 

that need to be reached before you can take the next step and invest the next set of money. 

Ms. DEGETTE. OK. I have one last question and 18 seconds. My 

question is, maybe for you and also Professor Taylor, do we have 

the technology right now in private industry to start exploring a 

food traceability system? 

Mr. LEVI. I am not an expert on that. 

Ms. DEGETTE. Maybe Professor Taylor? 

Mr. TAYLOR. Yes. I mean, when the market creates an incentive, 

industry has plenty of technology available to implement 

traceability. There are economic issues but again, that picture is 

changing as well see the impact of some of the problems where we 

don’t have traceability and the ability to—— 

Ms. DEGETTE. It costs money to do traceability but it costs a lot 

more money not to have any tomatoes being distributed, correct? 

Mr. TAYLOR. Absolutely. The market can compel it or you can 

compel it, you know. It could go either way if the capacity is there. 

Dr. MORRIS. If I could make the point again that perhaps rather 

than investing large sums in traceability, if we put the money in 

prevention. 

Ms. DEGETTE. Well, I actually think—— 

Dr. MORRIS. Both are important. 

Ms. DEGETTE. I actually think both are important. I completely 

agree with you that you are. That is why I also support mandatory 

63 

recall because I don’t really want to have to do mandatory recall, 

but I think it holds a hammer over the head and—— 

Dr. MORRIS. We need both. 

Ms. DEGETTE. They both work hand in hand. Dr. Cassell? 

Ms. CASSELL. I don’t want to frighten you but I do want you to 

appreciate that I believe we have the technologies today to apply 

to be able to detect parasitic and viral infections that are foodborne 

that we are not yet even screening for, and this is something that 

the new technologies, the new expertise would bring to bear, but 

I am quite honestly not convinced we are doing it, and that is what 

frightens me the most. 

Ms. DEGETTE. Dr. Cassell, if you are in this job long enough, 

nothing frightens you anymore. You just expect the worst. Thank 

you very much. 

Mr. STUPAK. Well, thank you. We have five votes on the Floor. 

We are going to recess until 12:30. I am going to ask this panel 

if they can stay. I know Mr. Doyle and others were here and wanted to ask questions. I know we may go another round because it 

is a very good panel. 

Thank you. We are in recess until 12:30. 

[Recess.] 

Mr. STUPAK. I call the Subcommittee back to order. A couple of 

members are going to come back for questions. I have a few more 

and then we will go back and forth, see who shows up. 

Let me ask Ms. Shames, let me ask you, if I may, you say on, 

I believe it is page 10 of your report, since 2004, 4 years, the GAO 

has been asking or made specific recommendations back in 2004 for 

the FDA to implement a strategy for food safety and 7 of those 34 

have been implemented, and part of it was improving monitoring, 

enforcement processes. And there were 21 recommendations you 

made with three of them being implemented or about 14 percent. 

If you take the 34 and seven of them have been implemented, that 

is about 20 percent. It has been 4 years. Why haven’t the other 80 

been implemented, or 80 percent of them, I should say, the other 

27. Any idea? 

Ms. SHAMES. Most of them FDA has started to take some initial 

steps but I think that is a very good question. I don’t have an answer for you. 

Mr. STUPAK. Back in 1998, the GAO also recommended, highly 

recommended, in fact, very forcefully recommended that the IT at 

FDA be improved upon. Have any recommendations from 1998, 10 

years ago, been implemented to bring the IT into compliance? 

Ms. SHAMES. There are others back at GAO who can talk more 

knowledgably about FDA’s IT system. I do know, of course, that if 

they are going to undertake a risk-based approach, data is absolutely important. Data are underpinnings to be able to make those 

priority decisions, and of course, IT systems would be absolutely 

necessary for that. 

Mr. STUPAK. And I think we established this earlier, but the 

extra money that Secretary Leavitt and Commissioner von 

Eschenbach asked for Monday night did not include any money for 

IT, for information technology. Is that correct? 

Ms. SHAMES. That is the way we understand it, yes. 

64 

Ms. STUPAK. You also note in your testimony that while FDA’s 

Food Protection Plan recognizes the need to partner with Congress 

to obtain 10 additional statutory authorities to transform the safety 

of the Nation’s food supply, you say, ‘‘FDA’s congressional outreach 

strategy is general.’’ What do you mean when you say that their 

outreach strategy is general? 

Ms. SHAMES. What we mean is that we would expect that FDA 

would know best the impediments that it has to conduct its regulatory authority. It would be presumptive on FDA to outreach to 

the Hill, to be able to provide draft legislation, to provide other 

technical assistance, to more proactively undertake to get the tools 

that FDA needs to be able to meet its mission. 

Mr. STUPAK. In other words, they need the legislative language 

to implement part of this? 

Ms. SHAMES. I would say that that would be one thing that they 

would do, yes. 

Mr. STUPAK. Professor Taylor, if I may, on page 13 of your testimony you say, ‘‘Over a year ago, the United Fresh Produce Association and Produce Marketing Association called on the FDA to establish produce safety standards that are federally mandated, riskbased and allow for commodity-specific regulation.’’ Did the FDA 

ever work with the produce associations to put forth this risk-based 

alternative? 

Mr. TAYLOR. My understanding is that there was work done 

within FDA to develop ideas for beginning that rulemaking, and I 

must say, I rely on press reports for my knowledge of the process 

but that effort was rebuffed in the Office of the Secretary so that 

a decision was made that at a level above FDA within the department not to proceed with that rulemaking. 

Mr. STUPAK. So the fresh produce producers said let us do something and it is your understanding they went to the FDA, the FDA 

thought it was a good idea but the Secretary, that would be the 

Secretary of HHS then, rebuffed the idea? 

Mr. TAYLOR. That is my understanding. 

Mr. STUPAK. On page 16, you say on the bottom of page 16, ‘‘I 

have great respect for Associate Commissioner David Acheson, but 

his position lacks budget or line authority for programs and thus 

in some way further clouds responsibility and accountability for 

food safety within FDA.’’ Is that your assessment of the food czar 

situation now? 

Mr. TAYLOR. Well, yes, I think that creating that position was an 

effort to recognize that food safety and responsibility for it is lodged 

in multiple components of FDA. There is a Center for Food Safety 

and Applied Nutrition, which people think is the lead agency. 

There is also the Center for Veterinary Medicine, which has significant food safety responsibilities. And then the Office of Regulatory 

Affairs at FDA, which manages the field functions, all the inspectors, and the laboratories, and actually consumes the majority of 

resources that are labeled food safety resources at FDA. All three 

of those major components are managed separately. They report to 

the Commissioner but the Commissioner has more than one fulltime job looking after the drug supply and the medical product side 

of the Agency, and so we have got a institution where food safety 

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nate out of the Commissioner’s office, which Dr. Acheson has been 

asked to do, is a worthy step, but anyone who has run a government program knows that if you don’t have line authority and resource allocation authority over the programs you are expected to 

coordinate; coordination is a very difficult thing. Management is 

what is necessary and the leadership that comes with the actual 

tools of leadership and management. 

Mr. STUPAK. So the food czar should really have direct authority, 

budgetary and line authority over veterinary and the Office of Regulatory Affairs? 

Mr. TAYLOR. I mean, my view is that these elements of FDA 

ought to be unified into a single functioning entity that is responsible for the food side of FDA’s jurisdiction, and with direct accountability to a single person who is in charge of food safety at 

FDA and has that as their full-time responsibility and can manage 

all the resources of FDA to do food safety. 

Mr. STUPAK. I see a lot of nodding of heads. Does anybody else 

want to comment on that? Dr. Cassell, Dr. Morris, Dr. Levi, Ms. 

Shames? 

Dr. MORRIS. I would just strongly second the need for this type 

of authority. From a scientific standpoint, one of the major problems that arises is the lack of coordination among the agencies, and 

having a single line authority is absolutely critical. We are just not 

getting anywhere because there isn’t that. I will say there is a larger problem and that there is further dissemination of responsibility 

in USDA and CDC, but that goes beyond what we are talking 

about today. 

Mr. STUPAK. Dr. Cassell, would you care to comment? 

Ms. CASSELL. I was actually just going to refer back to one of the 

other comments that you asked. I don’t want to be misleading. It 

is possible that maybe FDA in their request and the Secretary in 

his request, in their $275 million, were thinking that they would 

apply monies from that for IT. What we estimated is that $128 million would be needed for food safety, an additional $75 million for 

IT and an additional $172 million for drug safety and also to address the emerging science issue and the management issues. So 

I just didn’t want to mislead anybody. I don’t know what their intentions were but clearly, in our opinion, it would not address all 

of the needs that are as critical that need to be addressed. 

Mr. STUPAK. Right. In the June 9th request for the additional 

money, it was $125 million protecting America’s food supply, $100 

million safer drugs, devices, and biologics, and $50 million, modernizing FDA’s science and workforce. I didn’t see any breakdown for 

IT so that is why I was asking the question. Thank you. 

Mr. Shimkus for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Ms. Shames, there is a briefing binder. Dr. Morris, I think it is 

in front of you, not the Science Board one but—because I want to 

refer to tab 11 to begin with, and tab 11 has the business case 

paper for the Food Protection Plan. Have you seen this or reviewed 

this? 

Ms. SHAMES. Yes. 

66 

Mr. SHIMKUS. What information do you feel is lacking in this document that Congress would need to evaluate FDA’s justification for 

spending this money? 

Ms. SHAMES. This is the information that was released with the 

President’s budget in February of this year, and it does describe 

what FDA intends to do with the $42 million for this fiscal year, 

but beyond that, what we are looking for—and there is a statutory 

model for it—is to lay out over, let us say, a 5-year period, just 

what the long-term goals are for food safety, break those long-term 

goals down into interim goals, and to be able then to discuss the 

associated resource needs for both the interim goals and the longterm goals. And resource needs should be considered very broadly—dollars, people, technology, in other words, everything that is 

brought to bear to be able to accomplish that. That really is the 

minimum information, but under the Government Performance and 

Results Act, departments are to provide more information. What 

are the external factors, for example, that they identify that could 

somehow impede accomplishing their goals. And likewise, there is 

call for evaluations. If you haven’t achieved your goals, why not? 

Conduct some sort of formal evaluation to show that. 

Mr. SHIMKUS. And Dr. Levi, in the pandemic influenza thing, is 

that similar to the approach that we did with that, and that is— 

does that sound—— 

Mr. LEVI. The pandemic strategic plan, implementation plan actually does agency across the government agency by agency 6- 

month, 12-month, 18-month, 2-year, 3-year goals for a variety of activities. 

Mr. SHIMKUS. So we are saying that is a good model to move in 

this direction? 

Mr. LEVI. Yes. 

Mr. SHIMKUS. Let us go back to the briefing binder, Ms. Shames, 

on tab 10, 5 pages in, which is number 2, there is a quote, ‘‘Use 

enhanced modeling capability, scientific data and technical expertise to evaluate and prioritize relative risk.’’ From your information, do you know what this will cost to achieve or when the Agency will accomplish this task? 

Ms. SHAMES. Certainly not from this information. Now, we have 

received some internal documents that provide a little more detail 

on some of the deliverables associated with the strategic components, but there is nothing more publicly available. 

Mr. SHIMKUS. Should this be public? 

Ms. SHAMES. Yes, we believe that this sort of public reporting is 

useful for congressional oversight, reassures the public, especially 

at a time like this when there is a food outbreak. Public reporting, 

I think is a very healthy thing. 

Mr. SHIMKUS. It is transparent. People can evaluate and hold 

people accountable based upon the standards established, and I 

would agree with that. I am going backwards, sorry, but tab 7 now, 

which is a letter from Commissioner von Eschenbach to Senator 

Arlen Specter. We kind of talked about it today in some opening 

statements. He stated in his professional judgment that FDA needs 

the $275 million immediately to accelerate its reforms. You have 

reviewed that, I am sure. 

67 

Ms. SHAMES. We are familiar with this as well. The progression 

that you are presenting obviously gets more and more detailed so 

we do see some associated dollars here with the activities. I think 

what is interesting here is that this was the Commissioner’s professional judgment. We didn’t see this accompanying information with 

the amendment that the Administration just asked for. So I think 

it is reasonable to assume that this would be applicable but that 

is only because we have evaluators who are doing a side-by-side 

comparison. 

Mr. SHIMKUS. And we are legislators and we deal in public policy. We are always schizophrenic because on one hand, you know, 

we are—I think most of us understand FDA more money but we 

want to it to be accountable. We want it to be directed in the right 

ways. But of course, I am a fiscal conservative that doesn’t want 

to spend any more money, doesn’t want to raise any more taxes, 

and so it is a dilemma but it is easier for us to go to our constituents if there is a credible plan, if we can have goals and objectives 

that are attainable and then especially with all these problems that 

we have had. I mean, there is public awareness of the need to move 

more aggressively. 

Tab 13, this will be my last, at least in the binder, shows a menu 

of IT programs associated with different levels of funding, page 11 

in tab 13. Have you seen this information in the Food Protection 

Plan? 

Ms. SHAMES. I can’t say offhand. It certainly is aligned by the 

core elements that is in the Food Protection Plan. 

Mr. SHIMKUS. But this is the kind of stuff that we would hope 

to see in budgetary information that we are all kind of addressing. 

Ms. SHAMES. Absolutely. It lays out the dollars going forward 

and just what some of the activities are. 

Mr. SHIMKUS. Great. And while we go, you all are welcome to 

page through this in those tabs, but my time is expired. I will turn 

back to the chairman. 

Mr. STUPAK. Seeing no other members available for questioning, 

I would like to thank this panel again for your expertise and your 

input into this process, and I will dismiss this panel. Thank you 

again, and thank you for bearing with us. I said that we had five 

votes. We ended up having six so we went a little longer than what 

we thought, but thank you again for being here and thanks for 

your help. 

Ms. CASSELL. Mr. Chairman, as we are leaving, can I just make 

one statement? 

Mr. STUPAK. Yes. 

Ms. CASSELL. And that is that our committee certainly struggled 

with the issue, Mr. Shimkus, that you just described, i.e., the need 

for the plan and wanting the Agency to be accountable, and what 

we concluded was, in the absence of additional resources and significant resources, even if you had a plan, I think that there would 

be no hope and so I think that we concluded that the first thing 

that had to happen was to get those resources to the Agency and 

then to begin to help address the issues and to perhaps solidify the 

plan. 

Mr. SHIMKUS. Mr. Chairman, if I can follow up, and when I talk 

about the schizophrenia of public policy folks, that is why I focus 

68 

on this risk-based approach also because we are always going to 

have—we are never going to have enough money, but the question 

is, directing it into the area that we need, and really I like to 

incentivize the good actors. I really want the good actors to get patted on the back. Some will fall through the cracks somewhere down 

the line, we understand that, but if you can incentivize the good 

actors, go after the bad actors, I think that is a better application 

of our resources, and I appreciate those comments, Dr. Cassell. 

Mr. STUPAK. Thank you again. 

I now call our second panel of witnesses to come forward. On our 

second panel, we have Dr. David W.K. Acheson, Assistant Commissioner for Food Protection at the Food and Drug Administration, 

also known as the drug czar—food czar. Sorry. I gave you a promotion, drug czar. I just want to make sure you are paying attention. 

It is the policy of this subcommittee to take all testimony under 

oath. Please be advised that witnesses have the right under the 

rules of the House to be advised by counsel during their testimony. 

Doctor, do you wish to be represented by counsel? 

Dr. ACHESON. No. 

Mr. STUPAK. The witness indicated no. Then I will ask you to 

please rise and raise your right hand to take the oath. 

[Witness sworn.] 

Mr. STUPAK. Let the record reflect that the witness replied in the 

affirmative. You are now under oath, Doctor. We will now hear 

your opening statement. You may submit a longer statement for inclusion in the record. Please begin, sir. 

STATEMENT OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER FOR FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

SERVICES 

Dr. ACHESON. Good afternoon, Chairman Stupak and members of 

the subcommittee. I am Dr. David Acheson, Associate Commissioner for Foods at the Food and Drug Administration, which is 

part of the Department of Health and Human Services. I would 

like to thank you for the opportunity to discuss our ongoing activities to implement the Food Protection Plan to enhance food safety. 

As we all know, 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 at each of these steps. However, changes in consumer preferences, changes in industry practices, and the rising 

volume of imports have posed challenges that required us to adapt 

our current food protection strategies. 

To address these challenges, last November Secretary Leavitt 

presented to the President an Action Plan for Import Safety, or Action Plan, to enhance the safety of imported products. In conjunction with the Action Plan, FDA released the Food Protection Plan, 

which provides a framework to identify and counter potential hazards. Together, these Plans provide an updated and comprehensive 

approach to assure 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 

69 

promoting increased corporate responsibility to build safety in from 

the start so that food problems do not occur. The intervention element focuses on risk-based inspections, sampling, and surveillance 

at all points in the food supply chain to verify that the preventive 

measures are being implemented. The response element bolsters 

FDA’s emergency response efforts by allowing for better communication and increased speed and efficiency. 

To expedite implementation of both Plans, the Administration 

has amended its budget request for fiscal year 2009 to include an 

additional $275 million for FDA. This increase includes an additional $125 million to intensity efforts to implement the Food Protection Plan. This adds to the increase of $42.2 million proposed in 

the fiscal year 2009 budget announced in February. The $275 million increase also includes $65 million to modernize FDA’s information technology infrastructure, $25 million of which will specifically 

support our food safety and food defense programs. 

With the funding requested in the President’s amended fiscal 

year 2009 budget, we will hire an additional 353 FTEs to accelerate 

our Food Protection Plan implementation activities. These resources will allow FDA to achieve priorities, such as identifying 

and targeting the greatest risks for intentional and unintentional 

contamination; conducting essential research on mechanisms of 

food contamination and deploying new rapid screening technologies 

to detect microbial and chemical contaminants; conducting more 

risk-based inspections and strengthening our emergency response; 

establishing more rapid response teams; expanding FDA’s international presence to include offices in China, India, Latin America, 

Europe, and the Middle East; establishing IT systems to support 

interoperable databases that will enhance research, threat assessment, and surveillance; and improving our ability to conduct tracebacks. 

We are moving forward to work with partners to develop the necessary scientific foundation. FDA has established a number of 

cross-cutting implementation teams and is working with our external food safety partners to focus on key areas to support our implementation efforts. I would like to take a couple of moments to describe five of these key cross-cutting areas of focus that are current 

priorities. 

First, the risk-based approach. FDA has been using a risk-based 

approach for setting priorities for many years. However, there are 

new models relating to risk assessments and new mechanisms that 

could improve our risk-based approach. FDA has developed an internal steering committee and is working on defining appropriate 

models, examining product/hazard combinations, and ranking foods 

by their risk to public health. These will enhance our ability to 

maximize effectiveness of our resources by focusing on food products that pose the greatest risk. 

Secondly, outreach. FDA has undertaken a number of specific 

outreach activities. For example, we have met with representatives 

of many foreign governments, state, and local partners, industry 

and consumer groups. The agency recently opened a docket to collect comments from all stakeholders on implementation of the Food 

Protection Plan. To provide a forum for local, State and Federal 

partners to exchange information and ideas about implementing 

70 

the Plan, FDA will host a meeting on August 12–14, 2008, in St. 

Louis, Missouri, with officials from the departments of health and 

agriculture from all 50 States. 

Thirdly, traceability. FDA is currently reaching out to various organizations to gain a better understanding of best practices for 

traceability and the use of electronic track-and-trace technologies to 

more rapidly and precisely track the origin and destination of contaminated foods, feed, and ingredients. FDA will use this information to develop key attributes for a successful track-and-trace system. In addition, FDA plans to issue a request for applications to 

providing funding to six states to establish rapid response teams to 

investigate multi-state outbreaks of foodborne illness. 

Fourthly, FDA Beyond Our Borders. Consistent with the goals of 

the Action Plan and the Food Protection Plan, HHS and the People’s Republic of China signed an agreement to enhance the safety 

of food and feed exported from China to the United States. The 

agreement establishes a bilateral mechanism to provide greater information to ensure products exported from China to the United 

States meet U.S. safety standards. As part of its Beyond Our Borders Initiative, FDA has also made a commitment to station agency 

representatives in China. We are considering similar endeavors in 

other countries, as I mentioned earlier. 

Finally, voluntary third-party certification programs. In April, 

FDA published a notice in the Federal Register to solicit public 

comments on the use of voluntary third-party certification programs for foods and feeds including pet foods. Third-party certification could provide FDA with additional assurances of safety and 

with valuable compliance information that would allow FDA to allocate inspection resources more effectively. The public comments 

will assist FDA in the design and development of such programs. 

These are just a few of our current high-priority areas of focus 

as we implement the Food Protection Plan. In my written statement, I also provided numerous examples of specific implementation activities. 

In closing, FDA remains committed to working closely with all of 

its partners to implement the Plan’s measures to protect the Nation’s food supply. The degree of progress and the overall success 

are dependent on both resources and new legislation. As you know, 

the Food Protection Plan identifies legislative authorities that are 

necessary for achieving full implementation. We commend this 

committee for its work on drafting legislation and look forward to 

working with you on this important legislation as we move forward. We also urge Congress to provide the funding requested in 

the amended fiscal year 2009 budget. 

Thank you for the opportunity to discuss FDA’s activities to implement the Food Protection Plan. I would be happy to answer any 

questions. 

[The prepared statement of Dr. Acheson follows:] 

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Mr. STUPAK. Thank you, Doctor. Let me begin. In the President’s proposal for fiscal year 2009, you received $30 

million for food safety. What made the FDA realize that you need 

another $125 million for food safety here in the last 6 months? 

What made the light go on that you needed more funds for food 

safety? 

Dr. ACHESON. I think as we were beginning to address the implementation of the Food Protection Plan, based, as you pointed out 

earlier in this hearing, in November we published the strategy, a 

high-level document, and as we have driven that down to specific 

implementation and what it is going to cost in the 2008–2009 time 

frame, it was very clear that more money was going to be needed, 

and that helped drive it. 

Mr. STUPAK. So in November you said you put forth your Food 

Protection Plan and as you began to implement it, you realized you 

needed more money. Do I understand that right? 

Dr. ACHESON. Not exactly. When we put the Food Protection 

Plan out, it was clear, we stated publicly at the time that we would 

need more resources in order to specifically implement the full components of the Food Protection Plan. You asked specifically what 

drove us to come up with that number and that was as we were 

defining what we could accomplish in the 2008–2009 time frame. 

That helped drive where did that specific $125 million come from. 

Mr. STUPAK. OK. Because I am a little confused now, because 

when Commissioner von Eschenbach sat where you sat at our April 

22nd hearing I asked him about implementing this and if the total 

budget, the $59 million that was requested in 2009, was enough, 

and he thought that would be fine to implement this program. 

What happened between April 22nd and June 10th that you put 

forth the plan? 

Dr. ACHESON. I think as we moved forward and had further internal discussions, the Commissioner recognized that there were 

other areas where we could usefully use additional resources. 

Mr. STUPAK. Do you have any idea then what would it cost to 

implement the Food Protection Plan as written in November of 

2007? 

Dr. ACHESON. In its totality? 

Mr. STUPAK. Yes. 

Dr. ACHESON. We have thought this through over a period of 

2008, 2009 in a fair degree of specificity. Beyond that, it gets a little difficult to actually determine what resources it will take because so much of what you would do in the second and third year 

of the plan is dependent on the progress you make in the first year. 

To give you a specific example, if legislative proposals are enacted 

to require preventive controls, which is one of the things that is in 

the plan, to be able to enact that and make it happen and increase 

the levels of inspection and guidance required, that is going to require resources, and at this point I don’t know what those would 

be. 

Mr. STUPAK. All right, but how would you put forth a plan for 

food safety for the Nation but have no idea what it is going to cost 

after the first year of implementation and you are only off by $30 

million for food safety and you come back and you ask for $120 

some, so you are only off by four times. So if your initial assessVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00093 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
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ment was you only need $30 million for this when you submit the 

budget on April 22 besides our hearing to make you run up those 

numbers, Commissioner von Eschenbach says you only need $30 

million. Six weeks later you are coming up and saying no, we need 

$125 million, but after that, you don’t know what else you need. 

So how can you put forth a proposal to protect the American people 

and not even know what it is going to cost 1 year, 2 years, 3 years, 

4 years, or 5 years out? Do you have any ideas what it is going to 

cost 5 years out? 

Dr. ACHESON. At this stage, I couldn’t tell you what it is going 

to cost 5 years out. The key part here is to develop a strategy, a 

vision, lay out the plan, and as the hearings illustrated earlier, put 

more granularity and specificity into it. 

Mr. STUPAK. I agree, but you must have some guesstimation 

what it is going to cost. I mean, you would have to know it took 

4 or 5 years to do it, right? When you were doing this, you had to 

come up with some guesstimation. The Science Board, there is 

their binder right there, they gave estimations for 5 years out. Did 

you even look at their numbers and say they are probably in the 

right ballpark? 

Dr. ACHESON. I did look at their numbers and I don’t have any 

argument with them. 

Mr. STUPAK. So we should take the Science Board’s number then 

to help you implement this Food Protection Plan for the country? 

Dr. ACHESON. Well, as we both understand, there is a budget 

process that is followed in terms of FDA seeking funding. 

Mr. STUPAK. Correct. 

Dr. ACHESON. And in that context, we only take it out in terms 

of the money that we ask as far as the budget process allows. If 

you choose to take the Science Board’s numbers—— 

Mr. STUPAK. You were so wrong with your first request. It was only $30 million for food safety and 7 months later, now it is $125 

million for food safety. But yet the Science Board came up with 

$128 million for food in 2009, $283 million in 2010, $441 in 2011, 

$598 million in 2012, $755 million in 2013. As I think we heard 

Mr. Shimkus and others, we are willing to help out but we are not 

just going to throw money at a problem but we need some concrete 

estimates of what it is going to cost, where are we going with this 

whole process. If we go to the appropriators and say here is $128 

million, that is what we want next year, they are going to say what 

are we going to have for the following year and thereafter. I mean, 

it is a sizable amount of money. We are not even talking about information technology which everyone says you are very lacking in 

that area too. So I guess I am just trying to get some kind of sense 

of where we are going with it. 

Dr. ACHESON. Well, let me try to provide a little clarity. Certainly the number that is in the Science Board proposal for 2009 

is absolutely on track with where we now are for 2009 for food 

safety. It is essentially the same number. There is a couple million 

difference but it is the same number. 

Mr. STUPAK. Sure, that is just for food, but the Science Board for IT had $75 million. You don’t even bring that into play. 

Dr. ACHESON. No. As I said in my oral statement, there is new 

money in the 2009 request for IT, $25 million specifically for food 

89 

safety. So there is $125 million for food safety and on top of there 

that there is an additional $25 million for food safety-related IT in 

the 2009 request. So there is an IT component built on top of that 

$125 million for food safety in that 2009 additional request. 

Mr. STUPAK. My time is up, but let me ask you this. We got the 

Food Protection Plan, which I have said earlier was tailor-made to 

the President’s budget, original budget, and I have asked about a 

couple years out. So as the Agency’s food czar, do you plan to submit to Congress an implementation plan which shows milestones, 

costs for the period that it would roughly take to implement this 

Food Protection Plan roughly 5 years? Will you do that? Will you 

submit that to the Congress so we have some idea on where we are 

going with this process? 

Dr. ACHESON. I have the ability to submit to you milestones and 

an implementation plan and a more specific set of timelines as we 

have heard. In terms of what I can provide in resource requests 

around that, what I can tell you is that I will work within our Administration to provide you the maximum amount of information 

that we can provide you around the resources. I can only commit 

to provide you with details of how we will implement this plan. 

Mr. STUPAK. But you are the czar, you put together this plan. 

Why can’t you tell Congress, the American people what it is going 

to cost for the next 5 years, what milestones are going to be 

achieved? How are we going to address that, and if you could do 

that for us? Why do you have to stay within the Administration’s 

constraints? Why not do the job as food czar and say here is what 

we need, here is what it is going to take, here is my request for 

the Congress? Isn’t that sort of your authority as the food czar? 

Dr. ACHESON. Well, if you are asking me to go outside of my authority within the Administration, then that might put me in a bit 

of a bad place. 

Mr. STUPAK. But isn’t it really what we need to do to get at food 

safety? Whatever the next Administration, shouldn’t they submit a 

plan for 4 or 5 years so we know where we are going with this 

whole process? 

Dr. ACHESON. There needs to be a realistic assessment of what 

is this going to take, both in terms of an implementation strategy, 

FTEs, and obviously you are right, ultimate cost, but working within the constraints of the process—— 

Mr. STUPAK. But here is our problem. We heard the same thing 

in 1998 from the GAO. In 2004, GAO laid out 34 recommendations 

to be implemented, hasn’t been done. Then we had this food plan 

in November of 2007. You had the Science Board plan right there. 

We have so many plans floating around that never get implemented because no one ever has the courage to step forward and 

ask what needs to be done; here is what needs to be done, here is 

what it is going to cost us, and I think the American people would 

really like to say someone is finally addressing the issue. As Mr. 

Dingell said in his opening statement, they are tired of being sick, 

but if it is going to cost us a few pennies more if we can see results, 

we could probably implement it. 

Dr. ACHESON. Let me commit to giving you at least greater specificity on timelines, plans, short- and medium-term goals, longerterm goals that I will commit to do, and I will also commit to work 

90 

with the Administration to provide you whatever I can within my 

authority as associate commissioner in terms of resources. I can’t 

go beyond that. 

Mr. STUPAK. When can we expect that detailed plan? 

Dr. ACHESON. It is going to evolve. I think we can provide you 

a detailed plan over the next—for the next year to 18 months, 

probably within 6 to 8 weeks. We have gotten most of it. Part of 

the strategy here is trying to apply the logic. As you are building 

this plan, you have a lot of complex issues going on with a lot of 

activities, and we have captured much of that, but what you have 

got to do is, if you are going to set up a risk-based approach, you 

have to determine what is the logic flow through that, what do you 

have to do first, and we made a lot of progress there, so I would 

hope that within 6 to 8 weeks we can provide you something for 

at least the first 2 years, and then looking out beyond that in a—— 

Mr. STUPAK. Six to 8 weeks or a year to 18 months you are going 

to provide that to us? 

Dr. ACHESON. I hope within 6 to 8 weeks to be able to provide—— 

Mr. STUPAK. Because you gave us one year’s worth. This is the 

first year. This is your 2009 request, which had some details, but 

it is only—and that was the $42 million plan. We would like to see 

a full plan for a couple of years out. 

Dr. ACHESON. I would like to go into greater detail than what 

you are holding in your hand there for the next year. 

Mr. STUPAK. We would appreciate that. Should your budget, if 

you reach a milestone, should you get the money, I think Professor 

Morris said that we should tie it into a process where you do not 

receive the money unless you reach a milestone. Would you be in 

favor of that? 

Dr. ACHESON. I think you need to look at—there is always a danger that you won’t reach a milestone for some unspecified or 

unpredicted reason. Part of this process is transparent and exploratory. You can’t map out 5 years of how do we fix the food supply. 

This is the eighth hearing that you personally have held on this. 

Mr. STUPAK. Right. 

Dr. ACHESON. It is really complicated, as illustrated by the number of hearings, and the problems that we have got to address are 

multiple: they are domestic, they are international, and I am not 

going to commit to saying we will set a milestone 2 years out. We 

may or may not make that. That is just reality. That is life. 

Mr. STUPAK. Well, the Science Board right there, they have it all 

laid out right there for you, all you have to do. That is from A to 

Z, how best to do it. It is already laid out for you if you care to 

try it. 

Mr. Shimkus for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

I am going to page back here because I would—well, before I do 

that, I need to ask you to take back to Dr. von Eschenbach, I said 

in my opening statement, response to this Office of Criminal Investigations letter, and if you would see that you relay that request 

from me. I think Ranking Member Barton would appreciate it and 

it would help us with our good friends in the Majority who might 

91 

think we have to go to other extremes to get the information versus 

just a nice, polite letter. 

Dr. ACHESON. I apologize that you don’t have that I will most 

certainly take that back. 

Mr. SHIMKUS. Great. I always keep going back to this—have you 

looked at this national strategy for pandemic influenza and their 

implementation plan and looked at how the perception of the plan 

at least, the first panel seemed to think it did a couple things. It 

set out goals. It set out milestones. It set out funding. Have you 

all looked at that to look at a way in which—when corporate America wants to build hopefully a lot more coal-fired power plants in 

this country, they have to plan 10 years out to get through all the 

permitting, to get the land acquisition, to fight the environmental 

groups, hopefully win, and then build the project, buy the coal. Everybody has long-term plans. That is our frustration. So, one, have 

you looked at that as a guide, and then if so, what have you determined and there is legislative action that we need to do to help you 

do that? When we do our budget, and I have problems with our 

budgetary process. Like I said, I like to have really the cost structure be a 2-year cycle but we do a 5-year. Ours is a 5-year budget 

plan. Now, we know we are not going to achieve it. We know there 

are going to be different areas that are going to be skewed, but at 

least we have an idea of what is going to happen, where tax cuts 

may be required to expire or other things. So talk to me about the 

influenza analysis and then again the whole budgetary cycle. 

Dr. ACHESON. In terms of your question about the pandemic 

plan, I personally have not looked at that for quite some time. I 

was certainly interested in following it when it was being developed. The discussion earlier today has illustrated that I need to go 

back and have a look at that specifically in terms of the way it was 

laid out and structured and see if it applies to the Food Protection 

Plan or at least if elements of it can be applied to the Food Protection Plan. It is clearly a model that you all feel works and is successful and we should pay attention to that and go and look but 

at this point I need to make that assessment. In terms of the budget process, essentially it is what it is and what we do—— 

Mr. SHIMKUS. But the submission by the Administration is not— 

I mean, we don’t pass that and it doesn’t go back to the President. 

It is not signed into law. When we pass out budget, it is not—we 

don’t send it back up to the President to get signed into law. It is 

a guide that directs our appropriators to spend money a certain 

way and they have to do the allocations and that is how the process kind of begins. It is very frustrating. 

Dr. ACHESON. Well, we are under constraints within FDA in 

terms of the budget process and we have to follow that. That is the 

way the law is written and that is what we have to do. So within 

that, we certainly operate within those constraints and clearly if 

you were to change those, then we would respond accordingly. 

Mr. SHIMKUS. We have a lot of million-dollar numbers floating 

around here, trying to get a handle on. The request, the Administration has added a $275 million request to the 2009 budget with 

$125 million of that for food protection. Is that your understanding? 

Dr. ACHESON. Yes. 

92 

Mr. SHIMKUS. And that is on top of the $42 million and then the—so there is $42 million and $125 million of the $275 million 

that is food protection addition dollars? 

Dr. ACHESON. Correct. 

Mr. SHIMKUS. How are you going to use that money to accelerate 

the plan’s implementation? 

Dr. ACHESON. Probably the easiest way for me to answer that is 

I think in the book that you had here, you have a copy of the professional judgment from our Commissioner which lays out in some 

detail how it would fall under prevention and intervention and response. But within that, we have got essentially money and FTEs 

allocated to increasing FDA’s presence beyond the borders, as an 

example, setting up the office in China, trying to set up, establish 

the offices in India and Central and South America, those sorts of 

things. Also, increasing our ability to provide technical assistance 

to foreign countries that need it, that requires resources and people. And developing the tools, IT tools and others for international 

information exchange to help inform the risk-based process. There 

is a lot ofyou probably don’t want me go through—— 

Mr. SHIMKUS. Let me then add to, now we also have the additional $275 million in new resources through the proposal of the 

budget supplemental, correct? The emergency supplemental. That 

is— 

Dr. ACHESON. Through the fiscal year 2009 addition, $125 million added in the fiscal year 2009 change. 

Mr. SHIMKUS. Yes, but the response to Senator Specter on the 

2008, in this emergency supplemental requested an addition of 

$275 million? 

Dr. ACHESON. Well, are we talking about a supplemental or are 

we talking about the—— 

Mr. SHIMKUS. I am talking about both, and that is the problem, because the basic—if the emergency supplemental of $275 million 

gets approved, can you deal with that money? 

Dr. ACHESON. Absolutely, no question. 

Mr. SHIMKUS. And what will you do with it? 

Dr. ACHESON. We will do exactly what we will do with it if we 

got it in 2009. We would just do it sooner. 

Mr. SHIMKUS. Mr. Chairman, my time is expired. Thank you. 

Mr. STUPAK. Thank you, Mr. Shimkus. 

Ms. DeGette for questions, please. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Dr. Acheson, when Commissioner von Eschenbach appeared in 

front of this committee almost a year ago, Tuesday, July 17, 2007, 

and announced your appointment as the new czar, he said, ‘‘This 

plan will enable FDA to be engaged in quality assurance through 

the total life cycle of food from its very production all the way to 

consumption. If you will, FDA’s commitment is to be engaged from 

farm to fork, and to do that in the context of a comprehensive, welldeveloped plan that includes prevention so we can eliminate food 

safety problems by building quality into our very production of 

food.’’ Would you agree that is the general purpose of what you are 

supposed to be doing with this new plan? 

Dr. ACHESON. It is heavily focused on prevention but with intervention and response built in as well. 

93 

Ms. DEGETTE. OK. So this plan now that came in out in November 2007, would you say that this is a comprehensive, well-developed plan? 

Dr. ACHESON. It is a comprehensive, well-developed strategic vision of where to take food safety. 

Ms. DEGETTE. Correct. As I said when I talked to the previous 

panel, there is nothing really very specific in here. It is general 

goals, right? 

Dr. ACHESON. It is a strategic vision. 

Ms. DEGETTE. OK. Now, we also have under tab 10 of your notebook the Food Protection Operations Plan. I am sure you are familiar with that as well, correct? 

Dr. ACHESON. Yes. 

Ms. DEGETTE. So my question is, would you say that is a comprehensive, well-developed plan? 

Dr. ACHESON. It does not give specific timelines and metrics. 

Ms. DEGETTE. It doesn’t give specific timelines, metrics, or price 

tags, does it? 

Dr. ACHESON. No. 

Ms. DEGETTE. So you wouldn’t say that is a comprehensive, welldeveloped plan, would you? 

Dr. ACHESON. I have already committed to provide that. 

Ms. DEGETTE. OK. And you have committed to provide that within 6 to 8 weeks from now, you say? 

Dr. ACHESON. For the next—— 

Ms. DEGETTE. For the next 2 years? 

Dr. ACHESON. Yes. 

Ms. DEGETTE. For the next how long a period? Because first you 

said 18 months, then you said 2 years. 

Dr. ACHESON. No, I said 18 months to 2 years. 

Ms. DEGETTE. OK. Great. So my question to you is it has now 

been 7 months since we received this whatever you called it and 

we haven’t had a specific detailed plan. Now you are saying another 6 to 8 weeks before a detailed plan. Is that going to have the 

breakdown with the metrics, and the price tags and so on and so 

forth? 

Dr. ACHESON. To the greatest of our ability, yes, it will have the 

breakdown of the metrics. 

Ms. DEGETTE. What does that mean? 

Dr. ACHESON. Pardon? 

Ms. DEGETTE. What does that mean and what do you need to get 

the ability to put metrics and price tags to all of the specific items 

in both of your Food Protection Plan and your Operations Plan? 

Dr. ACHESON. Well, the first point is what are the priorities over 

the next 18 months to 2 years? 

Ms. DEGETTE. Well, I would think the priorities would be to stop 

food outbreaks like the new outbreak that we have got with the tomatoes right now. 

Dr. ACHESON. That is the ultimate priority, to improve the safety 

of food. 

Ms. DEGETTE. Well, how long is it going to take for the ultimate 

priority to be achieved? 

Dr. ACHESON. To rule out outbreaks? 

Ms. DEGETTE. Well, to prevent outbreaks. 

94 

Dr. ACHESON. We will never completely prevent outbreaks. The 

goal is to minimize—— 

Ms. DEGETTE. OK, that is not productive. Let me ask you another question. In your Food Protection Plan, there are many sections that talk about additional legislative authority needed, correct? 

Dr. ACHESON. Yes. 

Ms. DEGETTE. Has the FDA come to Congress with any draft 

language for legislation needed to implement the plan? 

Dr. ACHESON. In the Food Protection Plan itself, the document 

you have there, there is a fair degree of detail in terms of what the 

specific legislative proposals would be. 

Ms. DEGETTE. OK. But has the FDA actually developed language 

to support those proposals? 

Dr. ACHESON. We have not provided legislative language—— 

Ms. DEGETTE. Does the FDA intend to develop language to support those proposals? 

Dr. ACHESON. At this stage, there is a great deal of language already developed by many members of Congress that we are providing technical assistance and look forward to doing more of that 

as we go on. 

Ms. DEGETTE. Which specific legislation are you referring to, sir? 

Dr. ACHESON. Yours, for one. 

Ms. DEGETTE. OK. 

Dr. ACHESON. There are many that are out there. 

Ms. DEGETTE. Now, isn’t it the case that the Administration did 

submit accompanying language with a number of recent legislative 

efforts including the Medical Device User Fee Act, the Animal 

Drug User Fee Act, the Generic Animal Drug User Fee Act, and 

the reauthorization of PADUFA? 

Dr. ACHESON. I was not familiar with any of those, but if you say 

that, I have no reason to—— 

Ms. DEGETTE. All right. But as far as you know, the FDA’s intent for these recommendations in your plan is to simply provide 

technical support to Congress but not to provide language. Is that 

correct? 

Dr. ACHESON. At this stage, there is no intent to provide specific 

legislative language. 

Ms. DEGETTE. Now, you had told Mr. Stupak that you cannot exceed the authority given by the Administration in terms of the 

budget. Is that correct? 

Dr. ACHESON. That is my understanding of my role, yes. 

Ms. DEGETTE. And what specifically are the parameters of that 

authority that you have been given by the Administration? 

Dr. ACHESON. My understanding of that is that during the development of a budget for 2009 or 2010 or wherever we are going, 

there is internal discussion that I take a major role in in terms of 

determining what are we going to need to move forward on whatever it is we are working on in the next stage of the Food Protection Plan. That is turned into a specific budget document, which is 

forwarded up through the departments, subsequently OMB, the 

President, and finally to Congress. 

95 

Ms. DEGETTE. And it is your understanding then that your authority does not include projecting out over 5 years or even 2 years 

budget numbers? 

Dr. ACHESON. My understanding of our ability, our authority is 

that if I was to do that, it would be for internal use only and I 

would not be allowed to share it. 

Ms. DEGETTE. And who told you that? 

Dr. ACHESON. That is my understanding of the law, and if I am 

incorrect, please correct me. 

Ms. DEGETTE. You believe that is according to the statutes? 

Dr. ACHESON. That is my understanding. 

Ms. DEGETTE. OK. And so how is it that you think you are going 

to be able to do a detailed plan for the next 18 months to 2 years 

if you are limited statutorily to only providing a budget for the 

coming fiscal year? 

Dr. ACHESON. What I committed to provide was a detailed implementation plan in terms of timelines and short- and long-term 

goals and I said I would work within the Administration to the best 

of my ability to provide maximum information on the resources required to achieve those goals. I cannot promise that. 

Ms. DEGETTE. Well, the problem we have is, if it is going to take 

a 5-year plan to fully implement the food safety regulations in this 

country, then we need to know how much it is going to cost and 

what we are going to need to do to do it. If in 6 to 8 weeks we receive more of this exhibit 10 or this other plan with sort of hortatory goals, that is not going to help us in feeling like we are developing legislation that is going to protect our constituents. You 

can see our frustration, Dr. Acheson. 

Dr. ACHESON. I understand. You want to know how much is it 

going to cost to implement—— 

Ms. DEGETTE. We want to know. We are not asking for a budget. 

What we are asking for is cost estimates, and we believe that is 

in your statutory authority, and furthermore, we don’t see how we 

can really do legislation. We don’t see how the FDA can implement 

a plan if it doesn’t have cost estimates that go out over the life of 

the plan. 

Dr. ACHESON. I understand your frustration. Will you allow me 

to explore that and see what I can provide? 

Ms. DEGETTE. Absolutely. When can you get back to us with an 

answer? Because part of my other frustration with FDA, although 

not with you personally, is that over the years I have asked for 

reams of information from the FDA on many, many topics and 

never received a response. So I know you won’t be that way, so 

when are you going to respond on that? 

Dr. ACHESON. I will. Until I explore the ramifications, I am 

loathe to commit to how long it will take but I will begin. I just 

don’t know. 

Ms. DEGETTE. Are you willing to meet with the chairman and 

ranking member of the Subcommittee next week to discuss this? 

Dr. ACHESON. I would be very willing to do that. 

Ms. DEGETTE. Thank you very much. 

Thank you, Mr. Chairman. 

Mr. STUPAK. Thank you. 

96 

Dr. Acheson, if I may, if you take a look at the frustration of 

what we are trying to ask you, if you go to page 5 of your plan, 

the Food Protection Plan, item 2, it states the following: ‘‘Use enhanced modeling capability, scientific data and technical expertise 

to evaluate and prioritize the relative risk of specific food and animal agents that may be harmful.’’ That is a very admirable goal 

but there is no spreadsheet. It doesn’t show how you intend to do 

this; how do you intend to accomplish this or what is the expected 

cost? So where would we find that information? I mean, this is a 

bunch of laudatory goals but it doesn’t say how you are going to 

do it. What do you expect to do? How are you going to achieve that 

goal of prioritizing the relative risk? What is the biggest risk we 

have in food right now? What is the biggest risk to this country’s 

health in food? I am not talking about tomatoes. What is the biggest risk? 

Dr. ACHESON. Probably meat and poultry. 

Mr. STUPAK. Meat and poultry, so that would be USDA. Give me 

one that is under your jurisdiction. What is the greatest risk under 

FDA jurisdiction? 

Dr. ACHESON. Fresh produce. 

Mr. STUPAK. Fresh produce, like spinach. How many outbreaks 

have we had of that? We have had—— 

Dr. ACHESON. Two. 

Mr. STUPAK. Man, the last 10 years I think there have been 

eight—— 

Dr. ACHESON. No, two with spinach. There has been eight or nine 

with other leafy greens. 

Mr. STUPAK. No, Salinas Valley, there has been at least 20 in 10 

years. 

Dr. ACHESON. Excuse me. I think you are confusing spinach with 

other leafy greens like lettuce, romaine lettuce. 

Mr. STUPAK. Right. 

Dr. ACHESON. Two spinach outbreaks, and you are correct; there 

has been seven or eight other leafy green outbreaks like lettuce 

and the like. 

Mr. STUPAK. In the Salinas Valley? 

Dr. ACHESON. Yes. 

Mr. STUPAK. So wouldn’t one of your priorities on the risk, if you 

are taking a look at Salinas Valley, which is the salad bowl of 

America and you have had 20 outbreaks of leafy greens in 10 

years. Wouldn’t that be a priority to try to crack down on that and 

get an epidemiology study to determine what is going on? Wouldn’t 

that be a priority? 

Dr. ACHESON. Absolutely. It is a priority, and that is why there 

was a leafy green initiative started, which is still underway. 

Mr. STUPAK. Right, and we have this Tomato Safety Initiative 

that has been going on for a year, so why is it the FDA is having 

a difficult time determining the source of the current salmonella tomato outbreak? 

Dr. ACHESON. There are two answers to that question. One is related to the complexities of a trace-back, particularly when it is 

linked to something like tomatoes where not every tomato has a 

code on it. The second part to your question is, how does that tie 

in with the tomato initiative that is currently underway in Florida 

97 

and in Virginia? That is essentially a collaborative effort to understand what is going on at the grower level, at the farms, that could 

help prevent future outbreaks. 

Mr. STUPAK. But you can’t determine that unless you know 

where the tomatoes are coming from. 

Dr. ACHESON. Well—— 

Mr. STUPAK. If the tomatoes are coming from Mexico, as some 

people suspect, then you have to know what the growing process 

is in Mexico and what the water they are using, what is the handling, what is the processing, what is the shipping. Would you not? 

Dr. ACHESON. I beg to differ. 

Mr. STUPAK. Really? 

Dr. ACHESON. Yes. Preventative controls to prevent salmonella 

getting on a tomato are going to work in Florida just as well as 

they are going to work in Mexico. The key thing is, what is the 

science behind the correct preventative control and then you apply 

it in Florida and you apply it in Mexico. 

Mr. STUPAK. Absolutely, if Mexico is doing the same as we do in 

Florida or Virginia or wherever we are growing tomatoes, right? 

Dr. ACHESON. You know, there are not a million different ways 

to grow tomatoes. 

Mr. STUPAK. Oh, I agree, but if your water isn’t clean in Mexico, 

I don’t care the way you grow it, you are probably going to have 

salmonella poisoning in the tomatoes, right? 

Dr. ACHESON. Having a water supply that is not heavily contaminated with salmonella is going to be important but that is true 

wherever you are growing them. 

Mr. STUPAK. Let me ask you this. The Food Protection Plan and 

what you have laid out here, how would that specifically have prevented the salmonella outbreak in tomatoes? If this was implemented, how would this have prevented it? 

Dr. ACHESON. If that is fully implemented, number 1, you would 

have done more research to understand the preventative controls 

and what actually works. To your point, is it the water supply that 

you have really got to control? What is the science behind that? 

What is the risk associated with water versus frogs that happen to 

be living in the field, so you would get to that point. And through 

the legislative proposals, you would have required the preventative 

controls to be put in place at the various points. 

Mr. STUPAK. OK, legislative proposals. Why haven’t you submitted any legislative proposals then to help us because you need 

legislators, us, to implement your plan? So why haven’t you submitted any legislative proposals to us? 

Dr. ACHESON. There is a fair degree of detail in terms of what 

those would look like in our plan and we have certainly met multiple times with staff on the Hill to discuss specifics around these 

and are now providing and want to provide more technical assistance and other discussions based on the language that has already 

been put out by a number of Congressmen. 

Mr. STUPAK. Tell me one Congressman who has a legislative proposal to implement this. 

Dr. ACHESON. Senator Durbin. 

Mr. STUPAK. OK. That is the other body. We can’t talk about 

them. I am talking about in the House. 

98 

Dr. ACHESON. There are many aspects in your bill that address—— 

Mr. STUPAK. But see, we are the committee that has sort of been 

looking at this and if we don’t know what those legislative proposals are; how is anyone else going to know? I would think if you 

are going to do legislative proposals to implement a food safety 

plan, you at least start with the Energy and Commerce Committee, 

who has jurisdiction over it. 

Dr. ACHESON. We have had many conversations with the Energy 

and Commerce Committee and I look forward to having more about 

the specifics of this, but the draft language that your committee 

came up with essentially used much of the proposals and thinking 

that were in the plan. 

Mr. STUPAK. So you support Mr. Dingell’s bill, the Globalization 

Food and Drug Act of 2008? 

Dr. ACHESON. There are many aspects in that which are synchronized with—— 

Mr. STUPAK. Would you please put in writing what you would 

agree with and not agree with in the globalization bill of Mr. Dingell so we have some idea where you agree and you don’t agree so 

we can work it out? Because we have nothing like that yet. 

Dr. ACHESON. We are certainly committed to providing the appropriate technical assistance along those lines, yes. 

Mr. STUPAK. You indicated when we were talking about Mexico, 

we were talking about the tomatoes, but you also indicated in your 

statement the FDA Beyond Our Borders and you specifically mentioned China. When we had our hearings on heparin, the agreement with China really didn’t help us any. When they tried to go 

into certain plants, they were not allowed to look for heparin. 

When they wanted to take a look at the labs, they were not allowed 

to. So how do these agreements, if the FDA inspectors cannot really get into the nitty-gritty to make the determination if the water 

is clean that is used to grow tomatoes, if it is not working in China, 

what is going to be different to make sure it is going to work in 

Mexico or China, whether it is food or drugs? 

Dr. ACHESON. With regard to the agreement in China, on the 

food side, that is, with AQSIQ, the regulatory body in China that 

controls exports, the process that we are undergoing there is that 

they have a registration and certification system in place. The 

question we have is, what comprises that? Does it meet our standards? That is the first question, at least on paper. Second question, 

when we go out and audit that process, which the intent is to do 

that sometime later in 2008, early 2009, are they actually doing 

what they say they are doing. Then the third part is assuming that 

they are, there needs to be an ongoing audit of the process, and if 

we start to receive certified product based on that process, we have 

got to do checks in the United States, and to your point, if we find 

that it doesn’t meet those standards, then clearly the agreement is 

not being met. 

Mr. STUPAK. Well, to my point then, if you don’t find that they 

are meeting the standards, if we take a look at drugs alone and 

there are many more hectares growing food for export to the 

United States than there are plants producing drugs in China and 

you are inspecting them, FDA is inspecting them every 30 to 40 

99 

years, that is not going to be very efficient. Now, I know you need 

more people, but would you commit to supporting the COOL, the 

country-of-origin labeling, so we can help understand where some 

of this food comes from so if you do have the outbreak like you do 

with tomatoes, if they came from China or from Mexico, which 

might narrow your focus on the salmonella in tomatoes, would it 

not? So would you commit to supporting the COOL program? 

Dr. ACHESON. Well, to answer the first part of your question, this 

is not all about having an FDA inspector going and visiting every 

foreign food manufacturing facility in China. This is about 

leveraging through the Chinese government, and if our voluntary 

certification program moves forward, through third-party voluntary 

inspections. 

Mr. STUPAK. The leveraging hasn’t worked; that we saw with 

heparin. We had this agreement. We were supposed to go into the 

plants when we wanted to go into certain plants, and Dr. Woodcock 

and Dr. Brown, they said they were denied access to plants and the 

labs to make sure, to see if that detail that we were supposed to 

do that and that the Chinese were following to certify these labs 

and the process. It was denied, so—— 

Dr. ACHESON. If access is denied and there is a problem, then 

clearly the agreement isn’t operating in the way the agreement was 

agreed, so that is a different issue. 

Mr. STUPAK. What about COOL? Do you support that, countryof-origin labeling? Will you implement it? 

Dr. ACHESON. Country-of-origin labeling is under the jurisdiction 

of USDA. 

Mr. STUPAK. But also you have responsibility for 80 percent of 

the food, most of our food, especially the fruits and vegetables and 

tomatoes that we are talking about come underneath your jurisdiction when they come from other countries, especially this time of 

the year, in the winter, so—— 

Dr. ACHESON. Country-of-origin labeling is no guarantee of the 

safety or lack thereof of a food. 

Mr. STUPAK. I agree, but it—— 

Dr. ACHESON. It is a piece of information for consumers. 

Mr. STUPAK. And it would also narrow your focus in trying to 

find out where this tomato outbreak is. If we knew those tomatoes 

were coming from Mexico because they were marked because they 

don’t have a bar code, as you said. But at least if they were 

marked, we could at least narrow our focus; could we not? 

Dr. ACHESON. Probably not, in fact, in practicality for tomatoes, 

simply because most people when they consume a tomato just know 

they have consumed a tomato. They don’t know where it came 

from. And by the time somebody—— 

Mr. STUPAK. You think consumers don’t know where food comes 

from if it is labeled? 

Dr. ACHESON. Well, let me ask you a question, if I may? 

Mr. STUPAK. Sure. 

Dr. ACHESON. If you have eaten a tomato in the last week, do 

you know where it came from? 

Mr. STUPAK. No, because you won’t implement country-of-origin 

labeling. If you had country-of-origin labeling, I would know where 

the tomato came from and you could focus your resources on MexVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00105 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
100 

ico, if that is where we believe the same is coming from, as opposed 

to New Mexico and Texas and the other States that you are sort 

of spinning the wheels on. 

Ms. DEGETTE. Will the chairman yield? Or if we had 

traceability? 

Mr. STUPAK. Right. 

Dr. ACHESON. I would support that, absolutely. I think 

traceability is a far more powerful tool than country-of-origin labeling in terms of food safety. 

Mr. STUPAK. So you don’t support country-of-origin labeling? 

Dr. ACHESON. I don’t go either way on it. My point is that it is 

not a food safety tool. It is an information for consumers tool. 

Mr. STUPAK. I agree, but it would help narrow your focus when 

you are doing investigations; would it not? 

Dr. ACHESON. It certainly wouldn’t hurt. 

Mr. STUPAK. If you had the address—when I did criminal investigations, if I had addresses, it would certainly help me out when 

I did mine. Let me ask you one more. 

Dr. ACHESON. Traceability would help you a whole lot more. That 

is what the address is giving you. It is giving you the traceability. 

Mr. STUPAK. That is right. Let me ask you one more question. 

The Office of Regulatory Affairs manages the majority of the FDA’s 

food safety resources through its field force of inspectors, compliance officers and laboratory personnel. Shouldn’t that be more consolidated underneath your position as Associate Director of Food 

Safety? 

Dr. ACHESON. The way that the Commissioner has chosen to set 

up my position is to give me the mandate of integration and coordination across the Agency. This is essentially the structure that he 

has established. I achieve that through providing essentially the 

leadership and the vision with ORA and CFSAN and CVM and the 

National Center for Toxicological Research and others working on 

implementing the Food Protection Plan. As you well know, the current structure is set up that way and that is the way that the Commissioner has decided to do it. 

Mr. STUPAK. All right. Our committee staff was at the Port of 

Baltimore to learn about the FDA’s entry reviewers inspect food 

imports using the IT platform called Oasis. As you know, current 

methods are often labor-intensive, are not interoperable with other 

existing databases and provide almost no risk analysis to inbound 

food commodities. So under the Food Protection Plan, how will the 

system change and when can we expect results? 

Dr. ACHESON. There are many components to answer your question. First of all, you need to be addressing what is the level of risk 

associated with certain foods, and it is not just the food product, 

the food hazard combination. It is where does that food come from, 

what do we know about the foreign manufacturer, many components that feed into this. The model that we have developed to 

begin to address this is Predict. Predict is run through a pilot program in the Port of Los Angeles looking at seafood. The evaluation 

of that program looked like it was successful. So the question is, 

how do we expand that, where do we go, and part of the Food Protection Plan includes the expansion of Predict. Some of the new 

101 

monies in the 2009 budget will go toward doing that. Are you going 

to ask a question? 

Mr. STUPAK. When will Predict then be validated if that is the 

new model? When will that be validated? It has been going on for 

some time for Los Angeles. I mean, in order to expand it other 

places, you have to validate its accuracy and— 

Dr. ACHESON. Yes. 

Mr. STUPAK. So when will that be done? 

Dr. ACHESON. The components of Predict are currently going out 

for peer review from FDA to see whether through peer review there 

is a sense that this works. We believe that we are now at a point 

where we need to do two or three things on Predict. One is to expand it on seafood to some other ports, see if it is applicable to 

other places. The second is to rank the food items under a series 

of priorities in terms of what is the next food that we would want 

to load into Predict and then to begin the process of risk ranking 

that food, because one of the powers of Predict is; it doesn’t just 

give you a yes-no answer. It gives you levels of risk depending on 

a variety of factors. And then the third component is to look at 

what is the IT interoperability, applying Predict across the whole 

system. Those three things will begin all in parallel, and the peer 

review process that is underway will help tweak, if necessary, the 

scientific approach and the data handling approach to make the 

system better. 

Mr. STUPAK. I appreciate your patience. 

Next to Mr. Shimkus for questions, please. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

I think they are going to call votes around 2:00. You will be 

spared from too much more harassment. I have three quick questions. They really do follow up on Predict. I am hopeful, and I think 

a lot of us are hopeful this will be rolled out to a larger venue. You 

made a statement already—some of my question was dealing with 

that and also if new monies come in, some would be directed—I 

think you have kind of mentioned that would happen. 

Dr. ACHESON. Yes. 

Mr. SHIMKUS. Can you—can the FDA provide a copy of the contract with New Mexico State University that pertains to Predict? 

Is that doable? 

Dr. ACHESON. Can we provide you with the contract? 

Mr. SHIMKUS. Yes, a copy of the contract. 

Dr. ACHESON. I can certainly see if we can provide you with that, 

yes. 

Mr. SHIMKUS. Good. I want to now jump to China real quick and 

these agreements that we have, not just with China but other 

countries. What insights are we gaining in our negotiations with 

other countries and in particular with China? Is there—in our negotiations with them, I think one of our concerns is the inspection 

and quarantine, address preservation of evidence, and access to 

personnel beyond just faster access to production facilities. Can you 

talk about that? 

Dr. ACHESON. Yes, this isn’t all about faster access to production 

facilities. It is about gaining a level of confidence in their registration and certification process. When they say that a shipment of 

shrimp is certified to be safe and meets FDA standards, we have 

102 

to be sure that that is true. That means getting an understanding 

of their systems, how do they inspect, not only the processing facility but the farm where these shrimp are grown, the control over 

use of inappropriate antibiotics—— 

Mr. SHIMKUS. Right, and that keys into the whole heparin debate 

that we were talking about because the ability of the Chinese government to go back to the hog confinement facility obviously is 

questionable, in fact, did not happen, and so these negotiations I 

think we are going to be—and how you all conduct those in the 

whole chain is going to be very, very important. 

Dr. ACHESON. I agree. We are at the point of laying out what the 

expectation is. There is an audit built into this. This is where we 

go and say—when you say that you are checking up on not only 

the processor but also the farm where these shrimp are grown, are 

they doing that and to what level and—— 

Mr. SHIMKUS. That is the accessibility part, though. 

Dr. ACHESON. Yes, and—— 

Mr. SHIMKUS. We have to have someone to be able, if there is a 

question mark, to be able to have those folks onsite that will get 

quick access to these facilities. 

Dr. ACHESON. Yes, it is a matter of gaining confidence in their 

system, and we have to do that by understanding the system and 

physically getting over there and looking at it and watching what 

they are doing and then continuing the audit process. 

Mr. SHIMKUS. Part of this whole FDA reform debate and legislation will be how do we fund, how do we bring more resources to 

you so we can effectively have the arrangement so that we have the 

people in these facilities, and there are a lot of us—what I want 

is, I want the people who want to provide, who want to sell into 

our market to help pay for us to make sure that those goods that 

people are trying to get access to our market is funding for your 

ability to make sure that they are safe. That is why it is timely. 

That is why this Oversight and Investigation Subcommittee is 

great because it really sets the building blocks for legislative response. 

The last time I want to tie in with this debate is using science. 

We had one of our hearings, we talked about irradiation, and of 

leafy greens. In fact, I double-dog dared the chairman to eat a leafy 

green that was irradiated. We found it was tasty. He wouldn’t eat 

the mushroom. But there is also gene splicing and other technologies that we will need your help to push forward as we—to 

hopefully overcome this concern. We would rather be proactive 

versus reactive. When we are reactive, then it is going to be costly, 

both in money, in human suffering and frustration, and these tomato folks, there is going to be a lot of people that are going to 

take a big loss and they are not going to be culpable or responsible, 

and so can you just talk briefly about technology real quick. 

Dr. ACHESON. Technology is critical. Utilizing modern technology, 

that is part of the Food Protection Plan. That is a high-level vision. 

And it gets down to detection technology: what can you develop in 

terms of handheld rapid detection technology. What is the prevention technology that works. I mean, you mentioned irradiation. Is 

that a reasonable approach that you could take that is actually economically effective and protects public health? You talked about geVerDate Nov 24 2008 11:00 May 17, 2010 Jkt 037690 PO 00000 Frm 00108 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-126 SCOM1 PsN: JIMC
103 

netic tools. Are there some components there that could help us? 

I think part of what we are going to use this new money for is to 

build up the scientific cadre within the Center for Food Safety and 

Applied Nutrition and the Center for Veterinary Medicine, and that 

will help address some of those questions, figuring out what is the 

new technology. We don’t have to develop all of that ourselves but 

what we have got to do is make the connectivity with academia and 

others and industry who have that technology and say well, that 

is interesting, we could apply that in a preventative mechanism for 

an FDA-regulated product. That only happens if you have enough 

people to get out there and have that dialogue, so it is all built in 

to that. I couldn’t agree more that modern technology is key here. 

Mr. SHIMKUS. And that will help us as we talk about what is the 

plan, what are the costs and that is that long-range debate and the 

milestones. That ties into the whole thing, and I am done, Mr. 

Chairman. I yield back. 

Mr. STUPAK. Thank you. 

Ms. DeGette for questions, please. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Dr. Acheson, I want to talk to you for a few minutes about the 

tomato situation. Has the FDA been able to trace the location of 

the original contamination of the tomatoes? 

Dr. ACHESON. Not yet. 

Ms. DEGETTE. And what is the process currently for trying to 

trace the source? 

Dr. ACHESON. I would like to first of all correct a mis-comment 

earlier in terms of this trace-back that has been going on since 

mid-April. It hasn’t. The first case from CDC was reported on April 

16. It wasn’t until May 31 that the link with tomatoes was officially made by CDC and the State and the local officials and FDA 

began its trace-back, so that was 12 days ago. 

Ms. DEGETTE. So what you are saying is that the first case of 

salmonella was reported in April but the CDC didn’t know what 

was causing the salmonella? 

Dr. ACHESON. What I am saying is, is that the first case, yes, 

was April 16. Now, you have to remember that you are talking 

here not just about CDC, you are talking here about the State and 

local public health infrastructure. 

Ms. DEGETTE. Right. I understand that, but what you are saying 

is the first cases of salmonella were reported in mid-April? 

Dr. ACHESON. Yes. 

Ms. DEGETTE. But the cause of the salmonella was not pinpointed until late May? 

Dr. ACHESON. May 31. 

Ms. DEGETTE. OK. And that is because—and I know how these 

public health issues are. They have these cases of salmonella, it 

took them a while to link that it was from tomatoes, right? 

Dr. ACHESON. That is right. 

Ms. DEGETTE. So what you are saying is, the trace-back efforts 

started May 31? 

Dr. ACHESON. Right. 

Ms. DEGETTE. So what is that process? 

Dr. ACHESON. OK. That process is when you know that you have 

got a patient who has consumed a tomato, you want to then find 

104 

out where did you buy it and when did you buy it. That will take 

you to the local supermarket. You then say to the supermarket, 

where do you get your tomatoes from in this time frame when the 

patient got sick, and it may be from two or three suppliers. You 

go back to each one of those suppliers and say where did you get 

your tomatoes from, and it may be from two or three distributors 

and the legs expand as you go out and you are chasing every one 

down. 

Ms. DEGETTE. Right. 

Dr. ACHESON. One of the legs that we are doing right now, beginning with a single case, it has led down five different sets of distribution, of which there is anything from two to nine different distributors or suppliers. The other complexity with tomatoes specifically is when a crate of tomatoes arrives at a distributing facility, 

they may handpick them because somebody says I only want small, 

unripe ones; somebody says I only want large, ripe ones. 

Ms. DEGETTE. Right. 

Dr. ACHESON. So they are pulling them out and mixing them up, 

and that has to be figured out. We have to get the invoices to show 

that it is tracking back. We have—as you know, we have excluded 

many areas of the country that either were not harvesting at the 

time—— 

Ms. DEGETTE. They weren’t harvesting? 

Dr. ACHESON. They weren’t harvesting or they were harvesting 

and where they were distributing was not where we were seeing 

illness so somebody who is distributing to the State it is grown in 

and the neighboring State, you see illness in 17 States, it is not 

them. 

Ms. DEGETTE. But it is sort of an inexact science the way we do 

traceability right now for produce and a lot of other food items too. 

Dr. ACHESON. It is actually very exact but it is very cumbersome. 

It needs to be exact to be legally binding. 

Ms. DEGETTE. Well, we had some hearings on the spinach issue 

and it took them a long time to trace that and they were never 100 

percent sure what the source of the contaminated spinach was. 

They thought they isolated it to a farm in California but they could 

never be 100 percent sure. I was actually encouraged when I heard 

you tell Mr. Stupak that you support trace-back provisions. First 

of all, we have the technology right now to do traceability for 

produce, correct? 

Dr. ACHESON. There is a lot of technology that is out there. It 

is not necessarily interoperable at this point. 

Ms. DEGETTE. And Dole, for example, is using trace-back process, 

correct? 

Dr. ACHESON. I don’t know. 

Ms. DEGETTE. If we could get interoperability with trace-back 

systems, that would expedite the traceability dramatically, correct? 

Dr. ACHESON. Interoperability is critical, yes. 

Ms. DEGETTE. But if we had interoperability, it would—— 

Dr. ACHESON. It would help. 

Ms. DEGETTE [continuing]. Greatly increase the response because 

it would be a lot more easy to pinpoint where that produce came 

from once you realized that the outbreak was caused by that 

produce, correct? 

105 

Dr. ACHESON. Assuming that the produce we are talking about 

had some marker on it that allowed you to—— 

Ms. DEGETTE. Well, right now when you go to the store, and I 

am amazed, frankly, when I go to the grocery store, everything you 

buy has now a little label on it. A tomato has a little sticky label 

on it. Each banana has a sticky label on it. So you can do that, correct? 

Dr. ACHESON. Yes, and often the labels have the country of origin 

on them, just as a point. 

Ms. DEGETTE. Well, right now I am focusing on traceability. 

Dr. ACHESON. I apologize. 

Ms. DEGETTE. And has the FDA investigated what it would take 

to make the traceability systems interoperable? 

Dr. ACHESON. We are actively doing that right now. We have met 

with a number of trade associations who are using traceability systems and they are a little different, and we are trying to right now 

understand what is the universe of traceability systems to begin to 

understand what might an interoperable system look like. 

Ms. DEGETTE. And what is your time frame for making those assessments? 

Dr. ACHESON. Well, I think clearly this tomato outbreak has accelerated those. There is no question. 

Ms. DEGETTE. So are you thinking again the 6- to 8-week time 

period, 3 to 6 months, a year? 

Dr. ACHESON. For what? For an understanding of what an interoperable system—— 

Ms. DEGETTE. For an understanding of what we would need to 

do nationally to implement a traceability system. 

Dr. ACHESON. I sincerely hope we would be there within a year, 

if not sooner. 

Ms. DEGETTE. OK. I am wondering if you have someone over at 

the FDA who is an expert in traceability that we might meet with 

as we develop our food safety legislation. 

Dr. ACHESON. We have many people who do this. 

Ms. DEGETTE. If you wouldn’t mind having those people get in 

touch with my staff, I would say next week also, that would be extremely helpful. 

Dr. ACHESON. Sure. 

Ms. DEGETTE. I have one last question, if I can find it. I don’t 

know if you are familiar with the letter that Senator Specter sent 

to Secretary Leavitt on June 10, 2008, about his concern about the 

budget amendment for the FDA for food safety. Are you familiar 

with that letter? 

Dr. ACHESON. I am familiar with some of the press around it. I 

haven’t seen the letter itself. 

Ms. DEGETTE. Well, in the letter—and I will have someone give 

you a copy of it—Senator Specter says, ‘‘The submission of your 

budget amendment at this time undermines the work that we have 

been doing to obtain these additional dollars on an expedited basis. 

The facts are that if these funds are not provided in the supplemental, no additional dollars will be available until March or April 

of 2009 at the earliest. Supporting additional dollars in fiscal year 

2009 sends a signal that there is no urgency in providing these 

funds.’’ It is in the third paragraph of that letter. I would ask you 

106 

if the department supports the providing of the funds in the supplemental appropriations bill so we can begin to get some funding 

for these food safety issues right now rather than waiting for an 

entire another year by going through the regular budget process? 

Dr. ACHESON. My understanding is that there is an active discussion between Congress and the White House right now, and that 

essentially all I know about that component is that it is under active discussion. 

Ms. DEGETTE. Well, let me ask you this. Would the Agency support—well, let me just strike that and ask you, if we could begin 

to provide the money to fund the Food Safety Plan right now, 

would that enable the Agency to start expediting some of the planning and some of the implementation that we all agree needs to 

happen right away? 

Dr. ACHESON. The sooner we get the money, the sooner we will 

be able to move and the faster we will be able to go. 

Ms. DEGETTE. Thank you very much. 

Mr. STUPAK. Let me ask just to wrap things up; the traceability 

now, are you saying that you support Ms. DeGette’s idea of 

traceability or will the Administration support it? 

Dr. ACHESON. I am saying that I am supporting the importance 

of traceability. 

Mr. STUPAK. So it is possible what happened with the United 

Fresh Produce Association and Produce Marketing Association 

when they worked with the FDA to establish safety standards, 

could get swatted down as one farther up the totem pole, right? 

Dr. ACHESON. Let me just back up a little bit. I haven’t read Ms. 

DeGette’s bill for a little while and I don’t remember the specifics 

in it, but what I can tell you is that traceability is critical in terms 

of response, and whether the Administration may ultimately take 

what Ms. DeGette’s draft language is, I couldn’t say. But the concept of traceability certainly is important. 

Mr. STUPAK. Well, you said all day today your hands have been 

tied with OMB as far as budget money. Testimony earlier was that 

the federally-mandated risk base that allow for commodity-specific 

regulation that the fresh produce association and the FDA started 

to swat it down by Secretary of HHS; so traceability, that I think 

we all agree would be helpful. It could get swatted down as it went 

farther up the chain, right? 

Dr. ACHESON. I can’t predict what farther up the chain may do 

to anything. All I can say is, is that from my role as associate commissioner for foods, traceability is important and I would advocate 

for it. 

Mr. STUPAK. You would advocate for it. Well, let me ask you this. 

So you advocate. Since we have had outbreaks of salmonella, E. 

coli, botulism over the past 12 months and in our last hearing on 

heparin, Dr. Woodcock agreed that subpoena power would be helpful. As food czar, will you also agree that subpoena power would 

be helpful to address the food-related outbreaks? 

Dr. ACHESON. Subpoena power for what? 

Mr. STUPAK. For records. Take ConAgra, the salmonella and peanut, we are still waiting for those records, and you have no subpoena power, FDA has no subpoena power to get those records. 

Would you support subpoena power to get records of the producers? 

107 

Dr. ACHESON. Well, through the Bioterrorism Act, we do have 

the authority to require records through section 414. If somebody 

has got—and we have done that a number of times in relation to 

foodborne outbreaks where—— 

Mr. STUPAK. Well, will you use it then to get the records from 

ConAgra for peanut butter? 

Dr. ACHESON. I don’t think we have used it for that. 

Mr. STUPAK. But will you? 

Dr. ACHESON. You are talking about old records. 

Mr. STUPAK. We are talking about past records. 

Dr. ACHESON. Yes. Records that are linked to a current ongoing 

situation, we use section 414 of the Bioterrorism Act and have used 

that to get records. 

Mr. STUPAK. So do you support subpoena power or not? 

Dr. ACHESON. I would have to get back to you on that to try to 

understand more specifically subpoena power, whether it is additive to what we already have or whether we would need it. 

Mr. STUPAK. How about mandatory recall? Would you support 

mandatory recall? 

Dr. ACHESON. Yes, that is in the Food Protection Plan. 

Mr. STUPAK. OK. And last but not least, we talked about Mr. 

Dingell’s legislation, the Food and Drug Administration 

Globalization Act of 2008. Will you get back, make a commitment 

to get back with us with specific technical assistance on the Dingell 

legislation? 

Dr. ACHESON. I certainly will promise to get back to you and 

probably the most constructive way is to have a direct dialogue 

over that. 

Mr. STUPAK. OK, but that does that mean you are going to provide the technical assistance? The Dingell draft has been around 

for some time and we have got nothing from the FDA. We have 

asked for it. 

Dr. ACHESON. I will—yes, the FDA will provide technical assistance. 

Mr. STUPAK. When? This year, next year? 

Dr. ACHESON. This year. 

Mr. STUPAK. How about next week? 

Dr. ACHESON. That may be a bit quick. 

Mr. STUPAK. All right. Six days then. I am not going up any further. 

Dr. ACHESON. Six days. 

Mr. STUPAK. All right. 

Dr. ACHESON. I will do my best. 

Mr. STUPAK. I will look for it in 6 days. Any questions? 

I want to thank you, Dr. Acheson, for your testimony and thank 

you for your time. That concludes all of our questioning. I want to 

thank all the witnesses for coming here today and for your testimony. I ask for unanimous consent that the hearing record remain 

open for 30 days for additional questions for the record. Without 

objection, the record will remain open. I ask unanimous consent 

that the contents of our document binder be entered into the 

record. Without objection, the documents will be entered into the 

record. 

108 

That concludes our hearing. Without objection, this meeting of 

the subcommittee is adjourned. 

[Whereupon, at 2:14 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

STATEMENT OF HON. JOE BARTON

Thank you Chairman Stupak and Ranking Member Shimkus, for holding this 

hearing today to examine FDA’s food protection plan. 

We are again reminded about how important food safety is with this week’s salmonella outbreak in raw tomatoes. Each year in the U.S. there are 76 million cases 

of food poisoning and 5,000 deaths, according to the Centers for Disease Control. 

What can we do to reduce the number of outbreaks? 

First, we can’t forget that in America, it isn’t the government that feeds the people. That system mostly collapsed along with the Berlin Wall. The government does 

have a role, though, and I think our first job is to examine policies that help promote innovation among the industries that produce the food we eat. For example, 

this subcommittee has already received testimony on the increased safety levels that 

can be achieved with more food irradiation. According to Dr. Michael Osterholm of 

the University of Minnesota, if 50% of meat and poultry were irradiated, 900,000 

fewer people would get sick and 300 fewer would die. 

Irradiation isn’t the only food safety technology available, however. There are new 

gene-splicing technologies that go beyond irradiation and could kill bacterial toxins 

before these microorganisms could grow within the plant cells. Unfortunately, the 

Luddites who insist on scaring consumers about the value of science and technology 

are hard at work, too, and I realize that winning broad acceptance of these new 

techniques is going to be a slow and difficult business. 

Second, we must bring FDA into the 21st century on matters of food safety. Today 

we will examine the FDA’s Food Protection Plan. We should look closely at the details and keep on top of this agency to make sure it can make the sustained effort 

necessary to implement its proposed reforms. 

This subcommittee’s work has helped the Agency and Administration respond to 

our findings—and the Administration really has responded. Just 2 days ago, Health 

and Human Services Secretary Michael Leavitt announced an amendment to the FY 

2009 FDA budget request that adds $275 million for food and drug safety. I think 

the President and Secretary Leavitt got it right, and I am in favor of this additional 

funding because I think it will go a long way to allowing FDA to correct the deficiencies that this subcommittee’s good work has highlighted over the past year. 

This is serious money, for a serious purpose. After eight oversight hearings and 

one legislative hearing on food safety, it’s time for us to join the Administration and 

start acting. We don’t have much time because as everybody in this room knows, 

the legislative window for this Congress is closing. Oversight functions can’t stop, 

but the legislating needs to start in earnest. 

I have made clear throughout these Oversight hearings that I support working 

with the Majority to craft effective legislation to authorize resources and reform this 

agency. We seem to agree on a lot of the same things, and I’m convinced that we 

have a real chance to create effective, bipartisan legislation that will help make people’s food safer. 

That brings me to my third point—bipartisanship. I’ve spent nearly a quarter of 

a century on this committee, and what I’ve learned tells me that major pieces of 

FDA legislation pass through this committee most easily and most effectively when 

we figure out how to work together. There just should not be any light between Republicans and Democrats on this issue, but the Majority’s a latest sweeping food and 

drug safety draft bill was written and made public with no input from the Republican side. 

I’m happy to report, however, that our staffs have been regularly meeting to overcome a poor start. I appreciate your efforts, Chairman Stupak. I hope we can see 

more bipartisan interaction on the legislation, especially now that the Administration has given us something to work with. 

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