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76–573 2012

THE ROLE AND PERFORMANCE OF FDA IN 

ENSURING FOOD SAFETY 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

MAY 6, 2010 

Serial No. 111–118 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan, Chairman 

BRUCE L. BRALEY, Iowa 

Vice Chairman 

EDWARD J. MARKEY, Massachusetts 

DIANA DEGETTE, Colorado 

MIKE DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

MIKE ROSS, Arkansas 

DONNA M. CHRISTENSEN, Virgin Islands 

PETER WELCH, Vermont 

GENE GREEN, Texas 

BETTY SUTTON, Ohio 

JOHN D. DINGELL, Michigan (ex officio) 

GREG WALDEN, Oregon 

Ranking Member 

ED WHITFIELD, Kentucky 

MIKE FERGUSON, New Jersey 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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

Texas, opening statement .................................................................................... 3 

Prepared statement .......................................................................................... 6 

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

California, opening statement ............................................................................. 11 

Hon. Robert E. Latta, a Representative in Congress from the State of Ohio, 

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

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

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

prepared statement .............................................................................................. 87 

WITNESSES

Michael R. Taylor, Deputy Commissioner for Foods, Food and Drug Administration; Accompanied by Steven M. Solomon, Assistant Commissioner for 

Compliance Policy, Office of Regulatory Affairs, Food and Drug Administration ........................................................................................................................ 16

Prepared statement .......................................................................................... 19 

Answers to submitted questions ...................................................................... 90 

Lisa Shames, Director, Agriculture and Food Safety, Government Accountability Office ......................................................................................................... 37 

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

Jodi Nudelman, Regional Inspector General for Evaluation and Inspections, 

Region II, Health and Human Services Office of Inspector General ............... 63 

Prepared statement .......................................................................................... 65 


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THE ROLE AND PERFORMANCE OF FDA IN 

ENSURING FOOD SAFETY 

THURSDAY, MAY 6, 2010 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 2 p.m., in room 2123, 

Rayburn House Office Building, Hon. Bart Stupak (chairman of the 

subcommittee) presiding. 

Present: Representatives Stupak, Christensen, Dingell (ex officio), Waxman (ex officio), Burgess, and Latta. 

Staff Present: Phil Barnett, Staff Director; Bruce Wolpe, Senior 

Advisor; Eric Flamm, FDA Detailee; Dave Leviss, Chief Oversight 

Counsel; Stacia Cardille, Counsel; Erika Smith, Professional Staff 

Member; Scott Schloegel, Investigator; Ali Neubauer, Special Assistant; Derrik Franklin, HHS–OIG Detailee; Karen Lightfoot, 

Communications Director, Senior Policy Advisor; Elizabeth Letter, 

Special Assistant; Mitchell Smiley, Special Assistant; Melissa Bartlett, Minority Counsel, Health; Kevin Kohl, Minority Professional 

Staff Member; Ruth Saunders, Minority Detailee; and Alan 

Slobodin, Chief Counsel, Oversight. 

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, ‘‘The Role and Performance of 

FDA in Ensuring Food Safety.’’ 

The chairman, ranking member, and chairman emeritus will be 

recognized for a 5-minute opening statement. Other members of 

the subcommittee will be recognized for a 3-minute opening statement. I will begin. 

Today’s hearing will mark the 12th hearing of the Oversight and 

Investigations Subcommittee since January 2007 regarding food 

safety issues. We have examined an E. coli outbreak traced to 

tainted spinach, melamine-contaminated pet food, and the industry 

practice of intentional exposure of meat and seafood to carbon monoxide, among other inquiries. During this Congress, the subcommittee has held hearings on a salmonella outbreak associated 

with peanut products manufactured by the Peanut Corporation of 

America; and actions and obligations of food manufacturers and retailers that purchased tainted food products; and the safety of bottled water. 


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Today, we will continue our oversight role and performance in 

the food safety system by considering two reports. The first is a 

Government Accountability Office report entitled, ‘‘Food Safety: 

Agencies Need to Address Gaps in Enforcement and Collaboration 

to Enhance Safety of Imported Foods.’’ 

GAO found that, despite the efforts and actions of the three Federal agencies that share jurisdiction over imported food—U.S. Customs and Border Protection, the U.S Department of Ag’s Food Safety and Inspection Service, and the U.S. Food and Drug Administration—there are gaps in the enforcement and collaboration that 

could allow high-risk foods to enter domestic commerce without assurance that products are safe. 

Specifically, the GAO found: the three agencies failed to collaborate and to share food-related data effectively; FDA’s authority to 

ensure importer compliance is limited; the agencies lacked the ability to assign unique identification numbers for importing firms; and 

CBP faces challenges managing inbound shipments. 

The second report, ‘‘FDA Inspections of Domestic Food Facilities,’’ was issued by the Department of Health and Human Services, Office of the Inspector General. The report identifies a number 

of challenges confronting FDA in safeguarding domestically produced food. 

OIG found that, on an average, FDA inspects only 24 percent of 

domestic food facilities annually and that the number of inspections declined from 2004 to 2008. The report also found that FDA 

has not inspected 56 percent of the food facilities under its jurisdiction during the past 5 years. 

The inspector general found that, and I quote, ‘‘When violations 

were identified, FDA did not routinely take swift and effective action to ensure that these violations were remedied,’’ end of quote. 

Additionally, the report found that some companies who had violations at their facilities significant enough to warrant regulatory action refused to grant FDA inspectors access to their official records. 

I am interested in learning more about these two reports and 

what proactive steps the GAO and inspector general believes FDA 

could be taking to ensure the safety of our Nation’s food supply. I 

am also interested in hearing from FDA on the recent steps it has 

taken to reinvigorate its focus on food safety and to improve and 

enhance food safety oversight. 

The work of this subcommittee, coupled with the work of the 

Health Subcommittee and the full committee on food safety, culminated the introduction and passage of H.R. 2749, the Food Safety Enhancement Act, which passed the House of Representatives 

on July 30th, 2009. 

The provisions contained in H.R. 2749 would address several concerns raised by GAO. For example, Section 204 of the bill requires 

all food importers to register with FDA annually, comply with good 

importer practices, and pay a registration fee of $500 in order to 

ship food to the United States. Section 206 requires that registered 

facilities have a unique facility identifier or they will not be allowed to import food into the country. I am interested in hearing 

from our witnesses how H.R. 2749 could help address the concerns 

raised in the two reports before us today. 


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Our witnesses today include the authors of the two reports. Lisa 

Shames is the director of the agriculture and food safety at the 

Government Accountability Office. Jodi Nudelman is the regional 

inspector general for evaluation and inspections for Region II at 

the U.S. Department of Health and Human Services, Office of Inspector General. 

Joining them on the panel will be Mike Taylor, FDA deputy commissioner for foods, and Steve Solomon, deputy assistant commissioner for compliance policy, from the Food and Drug Administration. 

The members of this subcommittee were the first to sound the 

alarm on the weaknesses of our food safety system. I look forward 

to hearing from our witnesses today about progress that has been 

made since we began pushing for reform more than 3 years ago 

and about the weaknesses that remain until we have an effective 

food safety bill enacted into law. 

We are fortunate that today’s hearing was prompted by the HHS 

and GAO reports rather than another widespread food outbreak 

like we saw with the spinach in 2007, peppers in 2008, and peanut 

butter in 2009. But make no mistake about it: Without legislative 

action, it is not a matter of if but when more lives will be put at 

risk by another outbreak. We cannot afford to put off action any 

longer. 

Mr. Burgess, opening statement, please? 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I thank the chairman for the recognition. 

And I am pleased to join you and the other members on the committee as we convene this hearing on the role of the Food and Drug 

Administration to ensure food safety for the American public. Food 

safety reform is relatively controversial, yet a critical issue, competing for attention with a long list of domestic priorities. 

Last July, in a bipartisan fashion, the House passed food safety 

legislation. I supported the legislation because, while historically 

the performance of the FDA has been questioned, I felt this was 

partly a result of inadequate tools. 

But the enduring role of the Food and Drug Administration 

today still remains a very complex question. The House legislation 

did not address the future progress of future inspection and whether or not it is the proper role of both the Food and Drug Administration and the United States Department of Agriculture to continue their bifurcated jurisdiction over food. We heard, for instance, 

that a food such as pizza if it has only cheese on it is wholly the 

province of the Food and Drug Administration, whereas if it has 

pepperoni as well, it is in the province of the U.S. Department of 

Agriculture. 

One thing is crystal-clear without controversy: The future of the 

FDA should not be as a reactive body dictated by the events of yesterday, but rather an effective and efficient, proactive agency preventing the emergencies of tomorrow. 

And I agree wholeheartedly with the chairman of this subcommittee when he says it is not a question of if but when. Because, as we were coming into the room for this hearing today, 


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across the newswire from the Columbus Dispatch, Federal health 

officials will come to Columbus this weekend to help determine 

what is responsible for a three-State E. coli outbreak that has 

sickened at least seven people there. So, as we see, even tomorrow’s 

headlines today are being covered in this committee. 

It is important for the Food and Drug Administration as well as 

the industry to work cooperatively to reduce the number of and 

help prevent food-borne illnesses and contamination before the 

tainted products are able to enter the markets. 

The Food and Drug Administration should make maximum use 

of information technologies for risk assessment, but it has come to 

my attention and the attention of the committee that the Food and 

Drug Administration has delayed the rollout of the promising new 

system, PREDICT. PREDICT uses a variety of assessments to rank 

food import shipments according to risk. The system is currently in 

use in New York and Los Angeles, but the nationwide deployment 

was recently postponed indefinitely because of technical problems. 

And this is not the first time that we have heard of the failure 

of the Food and Drug Administration to keep pace with changes in 

technology. From the failures of the 510(k) medical device process 

to the backlog of new drug applications to the entire portfolio of 

food issues, the Food and Drug Administration regulates fully 25 

percent of all government activity, yet the Food and Drug Administration remains technologically in the 1990s. This is why scientific 

innovation and information technology must play a central role in 

the prevention and the strategic analysis that is essential to a successfully functioning Food and Drug Administration. 

We are going to hear from four witnesses today, including two 

from the agency itself. And although much has been said about the 

past limitations of the agency and the uptick in funding shortfalls 

from a year ago, I do not believe that it is simply a resource question and that simply increasing the resources of the Food and Drug 

Administration will solve the problems outlined before us today. 

After numerous hearings, we have learned that simply providing 

more money to FDA will not, by itself, result in a safer food supply. 

From our agricultural imports to domestic manufacturing, the 

Food and Drug Administration must streamline the process and internal controls to identify high-risk products and manufacturers before tainted goods are able to enter the food supply. While continuing to collaborate with their counterparts at the USDA and the 

Customs and Border Protection, the Food and Drug Administration 

internal communications between Washington and their regional 

offices at home and abroad must be increased. Communication may 

not create the perfect system, but it will create a more reliable and 

a more efficient one. 

I am also interested in an update of the issues that still hinder 

work of the FDA and any new ideas you may have to foster innovation to improve the agency as a whole. As Commissioner Hamburg 

recently said, it is simply not possible for FDA to inspect our way 

to safety. 

Congress must advocate for an all-of-the-above approach in addressing food safety solutions. We must support and advocate for 

the FDA to continue to advocate for risk-based approaches to the 

inspection and testing processes, as well as support improvements 


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to modernize scientific standards, safety controls, and information 

technology. 

While these update reports from the Government Accountability 

Office and from Health and Human Services Inspector General are 

helpful, their reports do not change the conversation regarding this 

domestic priority. Food safety is important. Food safety legislation 

has passed the House. Food safety is now awaiting Senate action. 

So I hope today’s hearing is not just to continue to put pressure 

on the Senate to act for food safety. It is my understanding that 

the Senate is already planning to vote on this issue as soon as the 

Financial Services bill is finished. I hope, instead, we also ask 

questions about whether the progress and the evolution of food 

safety requires more advancements than red-tape bureaucracy than 

the government will logically allow. 

I would like to thank the chairman again, and I look forward to 

the testimony of our witnesses and to our questions. 

I will yield back. 

[The prepared statement of Mr. Burgess follows:] 


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Opening Statement of the Honorable Michael C. Burgess 

Subcommittee on Oversight and Investigations 

Hearing on 

"The Role and Performance of FDA in Ensuring Food Safety" 

May 6th, 2010 

Thank you, Chairman Stupak. I am pleased to join you and the 

other Members of the Committee as we convene this hearing on 

the role of the FDA to ensure food safety for the American public. 

Food safety reform is a relatively controversial yet critical issue 

competing for attention with a long list of domestic priorities. 

Last July the House passed food safety legislation, bipartisanly. I 

supported the legislation because while, historically, the 

performance of the FDA has been lacking, I felt this was partly a 

result of inadequate tools, but the enduring role of the FDA 

remains a complex question. 

The House legislation did not address the future progress of food 

and whether it is the proper role of both the FDA and the USDA to 

continue in their bifurcated jurisdiction over food where, for 

Page i 1 
7 


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instance, if a food such as pizza has only cheese on it, it is wholly 

the provence of the FDA, whereas ifit has pepperoni as well, it is 

also in the provence of the USDA. 

One thing is crystal clear and without controversy. The future 

FDA should not be a reactive body dictated by the events of 

yesterday, but rather an effective and efficient proactive agency 

preventing the emergencies of tomorrow. 

It is important for the FDA as well as the industry to work 

cooperatively to reduce the number of, and help prevent, foodborne illnesses and contamination before tainted products are able 

to enter the markets. 

FDA should make maximum use of information technologies for 

risk assessment, but it has come to my attention that FDA has 

delayed the rollout of its promising new system, PREDICT. 

PREDICT uses a variety of assessments to rank import shipments 

according to risk. This system is currently used in NY and LA, but 

the nationwide deployment was recently postponed indefinitely 

due to technical problems. 

Page! 2 
8 


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This is not the first time I have heard of the failure of the FDA to 

technologically advance. From the failures of the 51 Ok medical 

device process to the backlog of New Drug Applications to the 

entire portfolio of food issues, the FDA regulates 25% of all 

government activity yet the FDA remains technologically in the 

1990s. 

This is why scientific innovation and information technology must 

playa central role in the prevention and strategic analysis that is 

essential to a successfully functioning FDA. We are going to hear 

from four witnesses today including two from the agency itself. 

Although much may be said about the past limitations of the 

agency and the uptick in funding shortfalls years ago, I do not 

believe that simply increasing the resources of the FDA will solve 

the problems outlined before us today. After numerous hearings, 

we have learned that simply providing more money to FDA will 

not by itself produce a safer food supply. 

From agricultural imports to domestic manufacturing, FDA must 

streamline the processes and internal controls to identify high risk 

products and manufacturers before tainted goods are able to enter 

the food supply. While continuing to collaborate with their 

counter-parts at CBP and USDA, FDA must continue to improve 

Page 13 
9 


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internal communications between Washington and their regional 

offices at home and abroad. Communication may not create the 

perfect system, but it will create a more reliable and efficient one. 

I am also interested in an update of issues that still hinder the work 

of FDA and any new ideas you may have to foster innovation and 

improve the agency as a whole. As FDA Commissioner Hamburg 

recently said, "It is simply not possible for FDA to inspect our way 

to safety." 

Congress must advocate for an "all-of-the-above" approach in 

addressing food safety solutions. We must support and advocate 

for the FDA to continue to advocate for risk-based approaches to 

the inspection and testing process as well as support improvements 

to modernize scientific standards, safety controls, and information 

technology. 

While these update reports from the GAO and the HHS IG are 

helpful, their reports, substantively, do not change the conversation 

regarding this domestic priority. Food safety IS important. Food 

safety legislation HAS passed the House. Food Safety is now 

awaiting Senate action. 

Page! 4 
10 


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So I hope today's hearing is not just to continue to put the pressure 

on the Senate to act on food safety. It is my understanding the 

Senate is already planning to vote on this issue as soon as the 

Financial Services bill is acted on. I hope instead we also ask 

questions about whether the progress and evolution of food 

requires more advancements then the red-tape bureaucracy of 

government will logically allow. 

I would like to thank the Chairman again, and I look forward to 

your testimony and questioning. 

Page: 5 
11 

Mr. STUPAK. Thank you, Mr. Burgess. 

Mr. Waxman, full committee chairman, opening statement 

please, sir? 

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

Mr. WAXMAN. Thank you very much, Mr. Chairman. I want to 

commend you for calling this important hearing and to examine the 

role of FDA in protecting the Nation’s food supply. 

Today we are going to hear from two reports, one from GAO, the 

other from HHS Inspector General, about the FDA performance. 

These two reports tell a story of an agency that is trying to keep 

the food supply safe but needs new authorities, more effective tools, 

and increased funding to meet its obligation. 

In GAO’s report, it found that FDA needs to coordinate its enforcement efforts better with other agencies. For example, FDA and 

Customs and Border Protection should be able to work together to 

assign a unique identification number to firms that import our 

food. This is currently not the case. In fact, there are some that 

have more than three identifiers, and GAO found one firm had 75. 

These multiple identifiers make it more difficult for FDA to track 

foods that are imported. 

GAO also questioned whether FDA’s current penalties are sufficient to keep an importer from violating FDA requirements. 

The OIG report focused on FDA’s inspection of domestic food facilities. They found that FDA inspected only 24 percent of food facilities each year between 2004 and 2008. The number of FDA inspections declined during that time, even as the number of facilities increased. Over the course of 5 years, FDA failed to inspect 56 

percent of facilities that were subject to its authority and only inspected an additional 14 percent. 

These two reports are very disturbing. It is a similar story to 

what we heard last year. We were told in the two hearings on salmonella outbreak in peanut butter that sickened over 700 people— 

and the investigators revealed executives at the Peanut Corporation of America knew their peanuts were testing positive for salmonella, but they chose to ship the tainted food anyway. 

Many of the concerns raised in these two reports and in the wake 

of the salmonella outbreak are addressed by the Food Safety Enhancement Act of 2009, which the House passed on a bipartisan 

basis. The legislation contains critical fixes. I am pleased that we 

are holding this important hearing. I hope the Senate will act soon 

and we will have this new legislation in place. And I hope we will 

see, through the efforts of legislation and oversight, a more comprehensive food safety regimen at FDA. 

Thank you for holding the hearing. I yield back my time. 

Mr. STUPAK. Thank you, Mr. Chairman. 

Mr. Latta for 3 minutes? 

We will try to get them in. 


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OPENING STATEMENT OF HON. ROBERT E. LATTA, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO 

Mr. LATTA. Well, thank you very much, Mr. Chairman and Ranking Member Burgess. 

First of all, thanks for holding this subcommittee hearing on the 

Food and Drug Administration ensuring food safety. And it is also 

an honor being recently appointed on the Energy and Commerce 

Committee, and I look forward to working with you on the important issues that come before the Oversight and Investigations Subcommittee. 

Instances of contaminated food products are a serious concern for 

the public. Just last week, the FDA announced that contaminated 

materials were used in production of several lots of pediatric Tylenol products. About 1,500 lots of the bottled products are currently being recalled. Furthermore, as the percentage of U.S. food 

supply imported from foreign countries increases and bioterrorism 

continues to be a threat, food safety is a critically important issue. 

Last summer, the House debated H.R. 2749, the Food Safety Enhancement Act, and it is expected that the Senate will soon take 

action on the legislation. 

I represent the largest agricultural district in the State of Ohio 

and am a member of the House Agriculture Committee. I believe 

that H.R. 2749 did not adequately address the concerns of the agricultural community, nor was it referred to the Agriculture Committee at that time for any hearings. Additionally, the Congressional Budget Office estimates that H.R. 2749 will authorize $2.314 

billion over fiscal years 2010 through 2014 and that it will take 

$3.5 billion for the FDA to administer the new regulatory activities 

under the legislation at that time. 

The spending level authorized by H.R. 2749 is of grave concern, 

especially when the September 2009 GAO report found that gaps 

in enforcement and collaboration currently undermine food safety 

efforts among Customs and Border Patrol, the FDA, and USDA’s 

Food and Safety Inspection Service. Furthermore, the same report 

indicates there is a lack of information sharing between the FDA 

and States during a recall, which impedes States’ efforts to quickly 

remove contaminated food. 

The safety and security of the Nation’s food supply is of utmost 

importance; however, with 15 Federal agencies already administering at least 30 Federal laws concerning food safety, I am concerned of the prospect of an increased size in the bureaucracy, 

budget, and statutory authority for the FDA when improvements 

in communication, collaboration, and technology have been recommended by the GAO. 

Mr. Chairman, I thank you for this opportunity. I look forward 

to hearing the testimony from the witnesses on the panel today. 

And I yield back. 

[The prepared statement of Mr. Latta follows:] 


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Congressman Robert E. Latta 

The Committee on Energy & Commerce 

Subcommittee on Oversight and Investigations 

Opening Statement - For the Record 

May 6, 2010 

MR. CHAIRMAN; RANKING MEMBER BURGESS: Thank you for holding this 

subcommittee hearing on the role and perfornlance ofthc Food and Drug Administration in 

ensuring food safety. It is an honor to have heen recently appointed to the Energy and 

Commerce Committee, and I look forward to working with all of you on the important issues 

that come before the Oversight and Investigations Subcommittee. 

Incidences of contaminated food products are a serious concern for public health. Just 

this week, the FDA announced that contaminated materials were used in the production of 

several lots ofpediatric Tylenol products, and about 1,500 lots of bottled products are currently 

being recalled. Furthennore, as the percentage of the U.S. food supply imported from foreign 

countries increases, and bio-terrorism continues to he a threat, food safety is a critically 

important issue. 

Last summer, the House debated H.R. 2749, the Food Safety Enhancement Act, and it is 

expected that the Senate will soon take action on the legislation. I represent the largest 

agricultural district in the state of Ohio, and am a former member of the House Agriculture 

Committee. I was displeased that H.R. 2749 did not adequately address the concerns of the 

agricultural community, nor was it referred to the Agriculture Committee for any hearings. 

Additionally, the Congressional Budget Office estimates that H.R. 2749 will authorize 

$2.314 billion over Fiscal Years 20 I 0-20 14, and that it will take $3.5 billion for the fDA to 

administer the new regulatory activities under this legislation during that time. 
14 


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CBO also estimates that the president's budget plan will increase the public debt to $20.3 

trillion by 2020, and a $655 billion deficit has been incurred in just the first five months of this 

fiscal year. Recently the President's Budget Director Peter Orszag, stated that "deficits of this 

size are serious, and ultimately unsustainable" and that signif1cant changes in policy are required. 

The spending level authorized by H.R. 2749 is of great concern to me, especially when 

the September 2009 GAO report found that gaps in enforcement and collaboration currently 

undermine food safety efforts among Customs and Border Patrol, the FDA, and USDA's Food 

Safety and Inspection Services. Furthermore, the same report indicates that there is a lack of 

information-sharing between the FDA and states during a recall. which impedes states' efforts to 

quickly remove contaminated food. 

The safety and security of the nation's food supply is of utmost importance. However, 

with 15 federal agencies already administering at least 30 federal laws concerning food safety, I 

am concerned by the prospect of an increased size in bureaucracy, budget and statutory authority 

for the FDA when improvements in communication. collaboration and technology have been 

recommended by the GAO. 

Mr. Chairman. thank you for this opportunity. and I look forward to hearing the 

testimony from the witnesses on the panel today. [Yield Back) 
15 

Mr. STUPAK. Thank you, Mr. Latta. Good to have you on board. 

Look forward to working with you. 

Mrs. Christensen for 3 minutes, please? 

Mrs. CHRISTENSEN. Thank you. I will try to be shorter than that. 

Every year, 300,000 people in this country are hospitalized and 

5,000 die after consuming contaminated food or beverages. So 

thank you, Chairman Stupak and Ranking Member Burgess, for 

following up on this issue. 

It is very important that we explore the weaknesses in the food 

safety network and the coordination, or lack of it, between CBP, 

FSIS, and FDA, as well as any new authorities these agencies 

might need. So I just look forward to hearing the testimony of our 

witnesses and to working with the subcommittee and the larger 

committee to address the gaps in our food safety system. 

And thank you, Chairman Stupak, once again, for holding this 

hearing on this issue that is really vital to the safety and health 

of everyone who lives in this country. 

Mr. STUPAK. Well, thank you. 

And we have 2 minutes left to vote. We have a series of votes. 

There are four votes, plus a motion to recommit. So we are going 

to stand in recess until 3:15. 

So this committee will be in recess until 3:15. 

[Recess.] 

Mr. STUPAK. The committee will come to order. 

Mr. Dingell, do you have an opening statement, sir? 

Mr. DINGELL. Mr. Chairman, I will dispense with my opening 

statement. I thank you. 

Mr. STUPAK. Very good. 

Then that concludes the opening statements by members of the 

subcommittee. I call our first panel. 

On our first panel we have Mr. Michael Taylor, deputy commissioner for foods with the Food and Drug Administration; accompanying him is Mr. Steven Solomon, assistant commissioner for 

compliance policy at the Food and Drug Administration; Lisa 

Shames, director of agriculture and food safety at the Government 

Accountability Office; and Ms. Jodi Nudelman, regional inspector 

general for evaluation and inspections for the Health and Human 

Services Office of Inspector General. 

We welcome you all. 

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? 

Everyone is shaking their head ‘‘no,’’ so I will take it as no. 

Please then rise, raise your right hand, and take the oath. 

[Witnesses sworn.] 

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

affirmative. 

You are now under oath. 

We are going to begin with your opening statement of 5 minutes, 

please. If you would like to submit a longer statement for the 

record, it would be accepted. 

Mr. Taylor, shall we start with you? 


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16 

TESTIMONY OF MICHAEL R. TAYLOR, DEPUTY COMMISSIONER 

FOR FOODS, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY STEVEN M. SOLOMON, ASSISTANT COMMISSIONER FOR COMPLIANCE POLICY, OFFICE OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION; LISA 

SHAMES, DIRECTOR, AGRICULTURE AND FOOD SAFETY, 

GOVERNMENT ACCOUNTABILITY OFFICE; JODI NUDELMAN, 

REGIONAL INSPECTOR GENERAL FOR EVALUATION AND INSPECTIONS, REGION II, HEALTH AND HUMAN SERVICES OFFICE OF INSPECTOR GENERAL 

TESTIMONY OF MICHAEL R. TAYLOR 

Mr. TAYLOR. Yes, sir. 

Good afternoon, Mr. Chairman, Ranking Member Burgess, and 

members of the subcommittee. I am pleased to be here today with 

my colleague, Dr. Steven Solomon, and to have this chance to talk 

with the committee about FDA’s food safety program. 

I also want to really thank you, Mr. Chairman, as well as Chairman Dingell, Chairman Waxman, and all the members of the committee, for your leadership in passing the Food Safety Enhancement Act, which we do hope will soon go to conference with the bill 

now pending in the Senate. 

As you know, food safety is an important priority for the Obama 

administration. Soon after taking office, the President established 

a Food Safety Working Group which brought together experts from 

all Federal agencies with responsibilities related to food safety. 

In its July 2009 report, the working group recognized the challenges posed by a rapidly changing and globalized food supply and 

the need to shift our focus to preventing food safety problems 

throughout the system. The working group also recognized the importance of inspections, recommending that the government 

prioritize crucial inspection and enforcement activity, build on and 

enhance State and local food safety efforts, and utilize better data 

to guide these efforts and evaluate their outcomes. 

In August of 2009, Commissioner Margaret Hamburg created my 

office, the Office of Foods, to lead a unified FDA foods program and 

to enhance FDA’s ability to meet today’s challenges in food safety. 

We recently launched the One Mission, One Program initiative, 

which involves over 100 experts from throughout FDA who are addressing topics crucial to the future success of the foods program 

and the implementation of the anticipated new legislation. This includes an inspection and compliance strategy group that is looking 

hard at the way we conduct inspections. 

FDA’s food safety inspections have focused traditionally on identifying sanitation, manufacturing, and product contamination problems in food facilities and gathering evidence of regulatory violations for use in possible enforcement cases. These efforts have contributed significantly to food safety over the years, but the preventive control requirements and other new tools provided by H.R. 

2749 would greatly enhance the ability of FDA investigators and 

FDA inspections to protect public health. 

We will, of course, continue to act to remove contaminated food 

from commerce, but our focus will shift from collecting evidence of 

food safety problems after they have occurred to ensuring that food 


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companies are doing what is necessary to prevent problems in the 

first place. 

Our goal needs to be high rates of compliance with the prevention-oriented standards envisioned by H.R. 2749. And to achieve 

this, we envision our investigators conducting a wider array of inspection activities than is common today and targeting those activities in ways that get the maximum compliance and public health 

bang for the buck. 

The recent Office of Inspector General report on domestic inspections is a useful snapshot of FDA’s food safety system as it has existed in recent years. OIG has identified areas of opportunity for 

enhancing FDA’s enforcement authority, and FDA has already addressed many of the issues noted in the report. 

For instance, improving the speed and predictability of follow-up 

to inspections and strengthening the agency’s enforcement program 

are top agency goals. Last August, Commissioner Hamburg announced six initiatives to ensure that enforcement actions taken by 

the agency are swift, aggressive, and will have a positive impact on 

public health. 

FDA appreciates OIG’s recognition of the gaps in the agency’s inspection authority, and we support their legislative recommendations. These include the use of civil monetary penalties for FD&C 

Act violations related to food and the authority provided in Section 

106 of H.R. 2749 for routine access to all records bearing on whether a food may be in violation of the act. 

The GAO report of September 2009 raised some important issues 

relating to the safety of imported food. The agency agrees with 

many of GAO’s recommendations, and we are working to incorporate them into both short-term and long-term initiatives. 

The report looked at FDA’s new PREDICT system for targeting 

import shipments. This technology, which is deployed in Los Angeles and New York, will improve import screening and targeting to 

better prevent the entry of unsafe foods and expedite the entry of 

non-violative foods. A pilot test of the prototype system showed 

that PREDICT works to target shipments that are more likely to 

be found violative when examined by FDA. 

FDA has encountered problems with rolling out PREDICT nationwide due to difficulties with incorporating it into the agency’s 

outdated IT infrastructure, which is now undergoing major upgrades. These problems have delayed the full deployment of PREDICT, but we will continue to move forward as expeditiously as 

possible, with full roll-out anticipated by the end of the year. And 

we will continue to evaluate and strengthen PREDICT as the 

project progresses. 

FDA was encouraged that GAO recognized the importance of new 

legislative authorities as a key to strengthening FDA’s oversight of 

imported foods. In accordance with GAO’s recommendations, FDA 

is working with Congress to obtain authority for civil money penalties and to acquire the use of a unique identifier by food facilities, 

both of which are provided by H.R. 2749. 

The House bill will provide other valuable tools for ensuring that 

importers reliably verify—and this is really important—reliably 

verify that the foods they import are produced in accordance and 

compliance with the same prevention-oriented standards that we 


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would make applicable to foods produced in the United States. We 

all know that for our food safety system to be effective, prevention 

must begin at the point of production, not at the port of entry. 

Mr. Chairman, protecting our Nation’s food supply remains a top 

priority for FDA and the administration. We really are at a historic 

moment for food safety in the United States. As we work collaboratively to improve our authorities, our practices, and our policies, 

it will enable us to meet the food safety challenges of the 21st century. And we appreciate the support of this committee and look forward to working with you in the future. 

Thank you. 

[The prepared statement of Mr. Taylor follows:] 


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,~"'Cr,," 

( -'" DEPARTMENT OF HEALTH AND HUMAN SERVICES 

,,~~t- Public Health Service 

TESTIMONY OF 

MICHAEL R. TAYLOR 

Food and Drug Administration 

Silver Spring, ~vlD 20993 

DEPUTY COMMISSIONER FOR FOODS 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

MAY 6, 2010 

FOR RELEASE ONLY UPON DELIVERY 
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INTRODUCTION 

Good afternoon, Chairman Stupak and Members of the Subcommittee. I am Michael Taylor, 

Deputy Commissioner for Foods at the Food and Drug Administration (FDA or the Agency), 

which is part of the Department of Health and Human Services (HHS). Thank you for the 

opportunity to appear before you today to discuss the safety of our nation's food supply, and 

in particular, the Agency's efforts to ensure the safety of imported food and our inspections 

program for domestic food facilities. I would also like to commend you, as well as Chairman 

Waxman, Chairman Dingell, Ranking Member Burgess, and other Members of the Committee 

for your leadership in passing the Food Safety Enhancement Act (H.R. 2749), important food 

safety legislation that we hope will soon go to conference with the bill pending Senate floor 

action. 

As you know, food safety is an important priority for the Administration. Soon after taking 

office, President Obama established a Food Safety Working Group (FSWG), which brought 

together experts from all federal agencies with responsibilities related to food safety, to improve 

the nation's food safety system by prioritizing prevention, strengthening surveillance and 

enforcement, and improving response and recovery. In its July 2009 Report on Key Findings, 

the Working Group recognized that the nature of our food supply is rapidly changing, presenting 

new challenges to our food safety system. An increasingly globalized food supply, changes in 

the U.S. population, and new dietary patterns have combined to create complex supply chains 

involved in bringing food to tables across the country. The report noted that food imported from 

over 150 different countries comprises an increasing percentage of the American diet. The 

Working Group also recognized the importance of inspections, recommending that the 
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government prioritize crucial inspection and enforcement activity, support safety efforts by state 

and localities, and utilize better data to guide these efforts and evaluate their outcomes. 

In August 2009, Commissioner of Food and Drugs Margaret Hamburg created the Office of 

Foods to lead a functionally unified FDA Foods Program and enhance the Agency's ability to 

meet today's challenges and opportunities in food and feed safety, nutrition, and other critical 

areas. 

The mission of the unified Foods Program is to protect and promote public health by: 

• Ensuring the safety of foods for humans, including dietary supplements; 

• Ensuring the safety of animal feed and the safety and effectiveness of animal drugs, 

including the human food safety of animal drug residues; 

• Setting science-based standards for preventing foodborne illness and ensuring 

compliance with these standards; 

• Protecting the food and feed supply from intentional contamination; 

• Ensuring that food labels contain reliable information consumers can use to choose 

healthy diets. 

The Foods Program leadership recently launched the "One Mission, One Program" Initiative, an 

effort involving over 100 experts throughout FDA, who are organized in 10 core groups that 

address topics crucial to the future success of the Foods Program. This includes an Inspection 

and Compliance Strategy Core Group that is looking at the way we think of and define 

inspections. 

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Broadly speaking, FDA's food safety inspections have focused traditionally on identifying 

sanitation, manufacturing and product contamination problems in food facilities, and gathering 

evidence of regulatory violations for usc in possible enforcement cases. These efforts have made 

important contributions to food safety over many decades. The food safety legislation passed by 

this Committee, however, would greatly enhance the public health value of FDA's inspections. 

The requirements in H.R. 2749 that food facilities have food safety plans and implement modem 

preventive controls, and the new tools provided to FDA to ensure those plans and controls are 

working properly, will shift the focus of inspections from collecting evidence of food safety 

problems after they have occurred to ensuring that food companies are doing what is necessary 

to prevent problems in the first place. 

We will of course continue to act to remove contaminated food from commerce, but the ultimate 

goal of our inspection and enforcement program must be to achieve high rates of compliance 

with prevention-oriented standards of the kind envisioned by H.R. 2749, and to do this, we 

envision our investigators conducting a wider array ofinspection activities than is common today 

and targeting those activities in ways that get the maximum compliance and public health bang 

for the buck. 

The Inspection and Compliance Strategy Core Group is developing ideas and options for making 

this shift. In addition to considering how best to use the anticipated new tools contained in H.R. 

2749, the group is critically evaluating how our new inspectional approach can take into account 

emerging technologies, food product type, the inherent risk profile of the food product, and the 
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compliance history of the firm, all with a view toward improving the efficiency and effectiveness 

of our inspections. In exploring these possibilities, we have reached out to other food regulatory 

agencies within and olltside the United States to better understand their approaches toward food 

safety and industry compliance, what has worked well, and how success was measured. 

Realizing that training and education, both for the inspection staff and for the food industry, 

will be key for sllccessful implementation of the new authorities we hope will be provided in 

legislation, we are exploring the idea of alliances with universities, associations, and other 

organizations to help provide training in preventive controls and develop comprehensive, robust 

food safety plans that can be tailored to a firm's operation. We have learned from past initiatives 

that the first step toward safer food production is a strong food safety plan, based on a sound 

scientific approach that identifies the hazards likely to occur and indicates the appropriate 

preventive controls to minimize food safety risks. 

FDA is continuing to develop a risk-informed process to better target our food safety inspections, 

sampling, and laboratory analysis of food products. In fiscal years (FY) 2008 and 2009, FDA 

used a risk-informed model to prioritize which food manufacturers it should inspect. The model 

considered such factors as association of specific food industry types with foodborne outbreaks, 

recalls andlor reports of serious adverse events, the inherent risk of food products, and the 

compliance risk offacilities, as determined by past inspection histories. The application of this 

inspections model has continued in FY 2010. 

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In September 2009, the Government Accountability Office (GAO) released a report to Congress 

entitled "Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety 

ofImported Food." Additionally, just last month, the HHS Office of Inspector General (OIG) 

released a report entitled "FDA Inspections of Domestic Food Facilities." Let me now focus on 

the findings oftlIese reports and FDA's response to them. 

GOVERNMMENT ACCOlJNTABILITY OFFICE REPORT 

FDA acknowledges that GAO has raised some important issues in its report on imported food. 

The Agency agrees with many of the GAO recommendations and will incorporate them, as 

appropriate, into both short-ternl and long-term initiatives to help ensure the safety of imported 

foods. 

FDA is continually striving to improve our oversight ofthc safety of imported food. To this end, 

the Agency is working with our regulatory partners, such as Customs and Border Protection 

(CBP), the National Oceanic and Atmospheric Administration, and state agencies, to better 

coordinate our efforts and to find new ways to collaborate. FDA also recognizes the need to 

continually update its systems and processes. For example, when fully deployed, FDA's new 

Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system 

will improve import screening and targeting to bettcr prevent the entry of adulterated, 

misbranded or otherwise violative foods and will expedite the entry of non-violative foods. The 

new system will provide additional infomlation to FDA staffto help them optimize decisions 

about targeting import entry lines. In June 2007, we launched a pilot test of the PREDICT 

prototype system on seafood lines. An evaluation showed that PREDICT substantially increased 
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the violation "hit rate," that is, entries identified by PREDICT with a higher risk score were 

ultimately found vio lative through field exams and/or laboratory sample analyses, thus providing 

a basis for improving the efficiency of our inspection program. 

FDA has encountered certain problems with rolling out PREDICT nationwide, due to difficulties 

with incorporating it into the Agency's outdated information technology (IT) infrastructure, 

which is in the process of undergoing major upgrades. While these problems have delayed the 

full deployment of PREDICT, we will continue to move forward as expeditiously as possible, 

and continue to evaluate and strengthen PREDICT as the project advances. 

We also believe that enacting the pending food safety legislation is critical to strengthening 

FDA's oversight of imported foods. H.R. 2749 would, among other things, provide valuable 

new tools for ensuring that importers reliably verify that the foods they import are produced in 

compliance with the same prevention-oriented standards that would be applicable to foods 

produced in the United States. For our food safety system to be effective, prevention must begin 

at the point of production, not at the port of entry. 

FDA's comments on GAO's specific recommendations are as follows: 

GAO Recommendation: To enbance FDA's autbority to oversee tbe safety of 

imported food, GAO recommends that tbe FDA Commissioner seek authority 

from the Congress to assess civil penalties on firms and persons who violate 

FDA's food safety laws. 

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FDA agrees and is working with Congress to include civil money penalty authority in food 

safety legislation. Section 135 ofH.R. 2749 would establish civil money penalties that FDA 

would be able to impose for violations relating to food. 

GAO Recommendation: GAO further recommends that the Commissioner 

determine what violations should be subject to this new FDA civil penalties 

authority, as well as the appropriate nature and magnitude of the penalties. 

FDA agrees that the Agency should determine whether or not to seek civil money penalties for 

particular violations under new authority and that FDA would take into account, as appropriate 

under such authority, the nature of the violation and other factors in determining the magnitude 

ofa penalty. 

GAO Recommendation: The FDA Commissioner should explore ways to 

improve the agency's ability to identify foreign firms with a unique identifier. 

FDA agrees with GAO that the use of a unique identifier would improve the Agency's ability to 

accurately identifY foreign firms. Use of unique identifiers would also aid FDA in targeting 

high-risk shipments, which are currently hindered when a firm that FDA has previously 

identified and targeted due to a history of exporting high-risk shipments llses a different 

identifier, or where a new identifier is assigned to the firm by the database that receives the 

import entry information. FDA supports new authority to require the use ofa unique identifier 

by food facilities and we are working with Congress to include such new authority in food safety 

legislation. Section 206 ofH.R. 2749 would give FDA the authority to specifY the unique 

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numerical identifier system under which persons must submit such unique identifiers as part of 

the requirement to register their food facilities with FDA. We also support language in section 

101 of the bill to require annual re-registration offood facilities, as that will keep information 

such as the unique identifiers more current. 

GAO Recommendation: To enhance agency coordination and to streamline 

FDA's refusal process with CBP's redelivery process, GAO recommends tbat thc 

FDA Commissioner and the CBP Commissioner jointly study, with input from 

agency field officials, ports where a joint initiative would be feasible. 

FDA believes that continuing to engage with CBP to develop joint refusal and re-delivery 

processes is important, but does not believe that a study is necessary. The Agency is working 

with CBP to develop a national procedure and implement ajoint FDA Refusal and CBP Redelivery form. If approved, the joint notice should: 

Improve importer compliance with FDA refusal procedures; 

Help ensure that violative products are exported or destroyed; and 

Expedite the response time for the entry refusal process. 

GAO Recommendation: To better leverage state resources for protecting the 

safety of imported food, GAO recommends that the FDA Commissioner reach 

out to states to find opportunities for additional coUaboration through contracts, 

cooperative agreements, and informal partnerships. 
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FDA agrees with GAO's recommendation to better collaborate with the states, and supporting 

state and federal cooperation is also a major priority for the FSWG. FDA's Office of Regulatory 

Affairs has included an option in the state contracts for import work for the past five years. 

Future planned State Infrastructure and National Integrated Food Safety System Cooperative 

Agreements would include the sharing of information on imported products and coordination of 

both import and domestic import surveillance. 

FDA has also increased working relationships with our state regulatory partners through a 

number of initiatives. These initiatives include increased communication with the states by 

sharing Agency reports of emerging issues with commissioned state officials, distribution of 

Reportable Food Registry reports with commissioned officials in affected states, state 

participation in major recalls, and the use of state-generated evidence and data in FDA regulatory 

actions. FDA is now connecting inspectional data to programs such as eSAF (electronic State 

Access to FACTS) and other state accessible programs. 

All state food contracts have basic inspection requirements with an option for states to perform 

additional inspections in specific food areas, such as imports. It may be difficult to get states to 

commit to new or significantly more inspections. Several states, under current food safety 

contracts, are now requiring furlough days each month because of state budgets and regardless of 

contract funding. FDA believes that we can effectively leverage state resources to achieve 

national food safety goals in a cost-effective way, and the Agency is exploring mechanisms for 

making the relatively modest federal investments in state food safety infrastructure that would 

make such leveraging most effective. 

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GAO also recommended that. in a product recall or foodborne outbreak situation, FDA share 

product distribution lists with the states. The Agency already shares product distribution lists 

and other confidential commercial infonnation with states in certain circumstances when 

permitted by law. However, FDA also supports changes to existing law to strengthen the ability 

of the Agency to share information with states. The Food Safety Enhancement Act includes such 

legislative changes. 

GAO Rccommendation: To hclp ensure that PREDICT is effectively targeting 

high-risk imported food shipments for field and laboratory examinations, GAO 

recommends that the FDA Commissioner develop a performance measurement 

plan prior to deploying the system at additional U.S. ports. 

FDA agrees that a performance measurement plan is key to successfully evaluating PREDICT 

and modifying it as appropriate prior to widespread deployment. FDA is developing such a plan 

which will assess whether PREDICT improves FDA's screening of import shipments, whether it 

provides FDA with better information for management and decision-making purposes, and that 

identifies indications of the system's public health impact. The plan will also assess PREDICT's 

functionality and quantify and qualify improvements over the current screening module (OASIS) 

while providing key baseline data for future assessments. The plan cannot be fully implemented 

until PREDICT has been in use nationwide for a sufficient period of time to allow the necessary 

data to be generated. 

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HHS OFFICE OF INSPECTOR GENERAL REPORT 

OIG's recent report on domestic inspections is a useful snapshot o[f'OA's food safety system as 

it has existed in recent years. OIG has identified areas of opportunity for enhancing FDA's 

enforcement authorities. The report also highlights the obligation and responsibility of industry 

for food safety and OIG has noted the need for better industry practices, such as improved 

traceability and accurate and timely registration. The recommendations in this report reflect 

FDA activities during the time period in which OIG studied our systems (FY 2004 to FY 2007). 

The Agency has already addressed many of the issues and recommendations noted in the report, 

and considerable progress is being made on others. FDA appreciates OIG's support for our 

continuing efforts to enhance food safety. 

FDA also appreciates OIG's efforts to quantify several issues with respect to inspections from 

FY 2004 to FY 2007. While FDA's internal analyses do not perfectly replicate these findings, 

we recognize the impOltance of follow-up on inspectional findings to make sure that public 

health is protected and to ensure swift and strong enforcement actions are initiated when 

significant violations arc not corrected or present a threat to public health. Improving the speed 

and predictability offollow up to inspections and strengthening the Agency's enforcement 

program arc top FDA goals. 

Better targeting of inspections to ensure the Agency has the greatest public health impact through 

prevention offoodbome illness is also a central focus of future efforts to improve FDA's food 

safety program. This includes targeting sectors and facilities that pose the greatest risk and also 

focusing more of FDA 's inspection activity on ensuring that within any facility, the firm is 

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meeting its responsibility to prevent food safety problems. The Agency believes there is 

significant opportunity to improve the public health productivity of FDA food inspections. 

New Authorities 

DIG Recommendation: Consider seeking statutory authority to impose civil 

penalties through administrative proceedings against facilities that do not 

voluntarily comply with statutory and regulatory requirements. 

DIG Recommendation: Seek statutory authority to allow .FDA access to 

facilities' records during the inspections process. 

FDA appreciates OIG's recognition of the gaps in the Agency's inspectional authority. FDA is 

seeking more effective enforcement tools and we support ~IG's legislative recommendations. 

As noted above, section 135 ofH.R. 2749 would expand civil penalties for Federal Food, Drug, 

and Cosmetic Act (FD&C Act) violations related to food, and section 106 would give FDA 

access to all records bearing on whether the food may be adulterated, misbranded, or otherwise 

in violation of the FD&C Act. Routine records access is of particular importance to FDA 

because it will help to determine whether industry is both implementing proper preventive 

measures and complying with recordkeeping requirements needed to respond to food safety 

problems or other public health emergencies. 

In addition, FDA and thc Administration support several new legislative authorities further 

advancing the Agency's ongoing efforts to prioritize prevention, strengthen surveillance and 

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enforcement, and improve response and recovery. New food safety legislation, coupled with the 

necessary resources, including new user fees, will enable FDA to increase site inspections and 

issue new, more modern and prevention-oriented food safety regulations. In addition to the 

legislative authorities already noted, additional necessary legislative authorities include: 

• Trace.ilbilityJZequirements - H.R. 2749 provides enhancements to FDA's ability to trace 

the origin and distribution of tainted food. FDA would issue regulations that require food 

producers, manufacturers, processors, transporters, or holders to maintain a pedigree of 

the origin and previous distribution history of the food and to link that history with the 

subsequent distribution history of the food. Prior to issuing such regulations, FDA would 

be required to conduct a feasibility study, public meetings, and a pilot project. 

• Mandatorv recall authority for foods - In cases where a food could cause adverse health 

consequences or death and a firm does not act promptly, it is important for FDA to have 

the authority to order a recall to remove the harmful product quickly from consumer 

channels to minimize illness or injury. 

Increased Inspections 

OIG Recommendation: Increase the frequency of food facility inspections with 

particular emphasis on high risk facilities 

Since the timeframc of the OIG report, FY 2004 through FY 2007, the Agency has received 

increased appropriations that have permitted us to increase the number of food facility 

inspections. For example, in FY 2010, FDA will be able to increase fieJd staff for the Foods 

Program to 2,505 from 2,166 in FY 2009 and 1,861 in FY 2008. These field staff, once on board 

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and fully trained, will allow the Agency to increase the number of food facility inspections it 

performs annually, and also conduct a wider array of inspections activities. FDA has conducted 

more foreign inspections in FY 2009 than in any other year in the history of the program and 

expects to exceed that level in FY 2010. 

In addition to FDA '5 efforts to increase the number of food inspections with these new resources, 

H.R. 2749 and the Food Safety Modernization Act of2009 (S. 510) both call for increased 

inspections. FDA agrees that it is important to expand inspection coverage of food facilities. As 

the Commissioner pointed out, however, in testimony last fall before the Senate Committee on 

Health, Education, Labor and Pensions, any food safety bill passed by Congress that calls for 

increased inspections mllst have a reliable, consistent funding source in order for FDA to fulfill 

its new inspections mandate and other responsibilities. Registration fees would provide a 

consistent source of fil1lding. 

Improvements in the efficiency of how FDA uses its inspection resources to achieve public 

health goals will also contribute to meeting inspection targets. FDA needs the ability to rely on 

inspections by other federal agencies as well as state, local, and foreign governments, and to 

establish a mechanism for augmenting direct FDA oversight through some international 

inspections by certification 0 f accredited third parties who can evaluate and certify foreign food 

facilities, perform inspections, and determine compliance with FDA standards. 

In addition to increasing the number of inspections, FDA is applying information leamed from 

the outbreak of Salmonella in peanut products to improve the inspection process and to identify 

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potential food contamination issues. In 2008 and 2009, FDA began proactively approaching the 

prevention offoodbome illness by conducting intensive environmental sampling during certain 

FDA and state contract inspections that involved food products and facility operations that arc 

more readily susceptible to pathogen contamination. Prior to this change, environmental 

sampling was initiated only when specific conditions observed during an inspection indicated 

that it was appropriate (so called "for cause" sampling). Through this environmental sampling 

approach, which requires a significant investment in inspection and analytical resources, 

unsuitable manufacturing conditions have been identified by FDA investigators that have 

resulted in corrective action at the processing facilities, as well as several product recalls to 

remove products from the market that were processed under unsuitable conditions prior to the 

occurrence of a public health incident. 

The additional information gathered from environmental sampling also provides FDA with 

broader situational awareness and will be considered during risk-based targeting and planning of 

field work. Also, since implementation, FDA has seen a number of firms adopt environmental 

sampling programs that assist in monitoring the in-plant conditions on a routine basis. Such an 

industry response is welcomed and encouraged since food safety is primarily the responsibility 

of the food industry while oversight is ultimately a shared responsibility between FDA, its 

regulatory partners, and industry. 

Strong Enforcement Strategies 

OIG Recommcndation: Take appropriate actions against facilities, particularly 

those that have histories of violations. 

15 
35 


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OIG Recommendation: Ensnre that violations are corrected for all facilities that 

receive Official Action Indicated (OAI) classifications. 

To address facilities that have a history of violations, Dr. Hamburg announced six initiatives to 

ensure that enforcement actions taken by the Agency are swift, aggressive, and will have a 

positive impact on public health. The initiatives that address the OIG rccommendations are: 

• establishment of a timeframe for submission of post-inspection responses; 

• a shift in the Office of Chief Counsel's review of Warning and Untitled Letters; 

• development of risk control and enforcement strategies with our regulatory partners; 

• Warning Letter and recall follow-up inspections; 

• swift, aggressive and immediate enforcement action; and 

• a Warning Letter close-out process. 

OIG Recommendation: Provide additional guidancc about when it is appropriate to 

lower OAI c1assiJications. 

FDA agrees with this recommendation and will revise the guidance in the ORA Field 

Management Directive #86: Establishment Inspection Report Conclusions and Decisions. 

CONCLUSION 

Protecting our nation's food supply remains a top priority for FDA and the Obama 

Administration. We are in a historic moment for food safety in the United States as we work 

collaborativcly to develop better practices, policies, and authorities that will enable us to meet 

16 
36 


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the food safety challenges of the 21't century. Thank you again for the opportunity to testify 

before you about our oversight of imported food and FDA's domestic inspections. I will be 

happy to answer any questions you may have. 

17 
37 

Mr. STUPAK. Thank you. 

Mr. Solomon, do you have anything to add? 

Mr. SOLOMON. No, thank you. 

Mr. STUPAK. Ms. Shames, would you like to do an opening statement? 

TESTIMONY OF LISA SHAMES 

Ms. SHAMES. Yes, thank you. 

Chairman Stupak, Ranking Member Burgess, and members of 

the subcommittee, I am pleased to be here today to discuss FDA’s 

oversight of imported food. 

Effective FDA oversight is critical to public health. About 60 percent of fresh fruits and vegetables and 80 percent of seafood are 

imported. 

My testimony today will focus on three key issues: FDA’s overseas inspections of imported food; gaps in import enforcement; and 

statutory authorities that could further help FDA. 

First, regarding the inspections: The number of FDA’s overseas 

inspections has fluctuated since 2001. As shown in Table 1, annual 

inspections ranged from 95 to 153 out of an estimated 189,000 foreign firms. These inspections were conducted in 56 countries, mostly in Mexico. FDA conducted 46 inspections in China during this 

time frame. 

To augment these inspections, FDA has opened offices in China, 

Costa Rica, and India and plans to open more in Mexico, Chile, the 

Middle East, along with the European Union. 

In addition, PREDICT, a risk-based computer program is to assist FDA inspectors flag higher-risk food shipments. As Mr. Taylor 

said, a pilot test of PREDICT was promising. PREDICT nearly doubled the percentage of field examinations that resulted in violations. However, FDA told us that PREDICT’s nationwide roll-out 

has been delayed, primarily because of technical problems. 

Second, we identified several gaps in enforcement that could 

allow food with safety violations to enter U.S. commerce. 

One gap is that FDA has limited authority to assess civil penalties on violators. Importers post a monetary bond for shipments 

to provide assurance that they meet U.S. requirements. However, 

even though the bond may be up to three times the value of the 

shipment, this sum may be negligible for a large importer. An unscrupulous importer may consider forfeiting the bond as a part of 

the cost of doing business. FDA agreed with our recommendation 

that it seek authority to assess penalties. We note that H.R. 2749 

provides for assessing penalties. 

A second gap is the lack of unique identification numbers. Importers get computer-generated ID numbers from FDA. Because 

importers may provide their names and addresses slightly differently for each shipment, multiple identifiers are generated. FDA 

officials told us that firms have, on average, three unique identifiers, and one firm had 75. In addition, foreign firms are to register 

with FDA and are assigned a registration number, as well. FDA 

told us that there may be duplicate registration numbers, as well. 

FDA agreed with our recommendation to pursue the use of specific 

identifiers. H.R. 2749 also provides for such a unique identifier system. 


pwalker on DSK7TPTVN1PROD with 
38 

A third gap is that FDA does not share product distribution lists 

with States during a food recall because the information is considered commercially confidential. State officials told us that, without 

this information, they lose time removing recalled food from grocery shelves. FDA agreed with our recommendation to find ways to 

share information to the States. 

On a positive note, one gap we found appears to be resolved. We 

were told that FDA now receives the arrival time of imported food 

shipments. This can help FDA coordinate any further review for 

high-risk imports. 

Finally, we have made several recommendations that would help 

FDA improve food safety oversight. GAO has called for mandatory 

food recall authority. Currently, food recalls are voluntary, and 

FDA has no authority to compel companies to recall contaminated 

foods except for infant formula. Other government agencies that 

regulate other products, such as toys or car tires, have recall authority and have had to use it when companies did not cooperate. 

FDA should also strengthen its oversight of food ingredients determined to be generally recognized as safe, or GRAS. Companies 

may conclude a substance is GRAS without FDA’s approval and 

even without its knowledge because companies are not required to 

inform FDA. FDA generally agreed with our recommendation that 

it develop a strategy to require companies to provide basic information about their GRAS determinations and, in view of emerging 

science, to conduct reconsiderations of GRAS ingredients. 

We also recommended that FDA seek any statutory authority 

that the agency determines it needs to implement our recommendations. 

And, lastly, FDA agreed with our recommendation that it seek 

authority to issue regulations for preventive controls for high-risk 

food. As Mr. Taylor said, FDA already has regulations for preventive controls for seafood and juice which require firms to analyze 

safety hazards and implement plans to address those hazards. FDA 

officials told us that issuing regulations for preventive controls 

might be one of the most important things that they can do to enhance the oversight of fresh produce. 

We note that H.R. 2749 contains provisions that address mandatory recall, GRAS ingredients, and preventive controls. 

In conclusion, a substantial volume of our food supply is imported. Our work has shown that FDA could strengthen its oversight of imported food and close gaps in its enforcement by assessing penalties, developing unique identifiers, and sharing information with State agencies. Additional statutory authorities to conduct a mandatory recall and to establish preventive controls could 

further help FDA’s food safety. 

Mr. Chairman, this concludes my prepared statement, and I 

would be happy to answer any questions that you or other members of the subcommittee may have. Thank you. 

[The prepared statement of Ms. Shames follows:] 


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GAO 

For Release on Delivery 

Expected at 2:00 p.m. EDT Thursday, May 6, 2010 

GAO·I0·699T 

United States Government Accountability Office 

Testimony 

Before the Subcommittee on Oversight 

and Investigations, Committee on Energy 

and Commerce, House of Representatives 

FOOD SAFETY 

FDA Could Strengthen 

Oversight of Imported Food 

by Improving Enforcement 

and Seeking Additional 

Authorities 

Statement of Lisa Shames, Director 

Natural Resources and Environment 

! 

I=; GAO 

Accountability "'nllllrily " Rall.blllly 
40 


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Highlights otGA()'fQ.699T. tesllmony . 

before the Subcommittee on OVersight and Investigations. Committee on Energy_ and Commerce. House of Representatives 

Why GAO DId This Study 

Food Imported from around the ' 

world constitutes a substantial and i 

increasing poreentage of the U.~· " food supply. Ensuring the saCetyot . 

Imported food challenges the Food i :~~==~C:~etol fOO<!.s posing the greatest risks tG .oj 

publlchealth and tG coordinate I efforts with the Department of . , 

Homeland Security's Customs andj 

Border Protection (CBp)so that " " 

unsafe food does not ente. U.s. i commerce. 

This testimony focuses on (1) ~ FDA's ovemeas inspections, (2).j identified gaps in agencies' 1 

enfon:ement efforts to ensure the" 1 

saCety' of Imported food, and (3) . 

statutory snthorities that GAO has " 

identified that could help FDA's .. j oversight of food saCety,.This:. 

testimony Is pmclpalJy based orr' 

GAO's September 2000 report, . 

Food Sqfety, Agencie& Need IIJ I Address Gaps in E1Iforcenumt and I 

Colli:llJm'atlon IIJ Enhanca Sqfety of 1 

Imported Food(GA()$873) and I 

has been updated with infonnation 1 

:~:~O Recommends I GAO previously recommended that 1 FDA explore a unique identifier tor ',1 

firms; among other tIllI18S' GAO also recommended FDA seek' I 

statutoryanthorities as needed, I such as for preventive controls. ' 

FDAhas agreed with these j recommendations and has sought ! needed anthorities.. 

For 

_"'i,_,",~l mor.'lnformatlon; oontactUaaShamaa aq (202) 5f1Ml841 orshameslOgaO.gov_. ; · .. ·.1 , ~. '--4 , 

May 6, 2010 

FOOD SAFETY 

FDA Could Strengthen Oversight of Imported Food by 

Improving Enforcement and Seeking Additional 

Authorities 

What GAO Found 

While the number of FDA overseas inspections has fluctuated, FDA has 

opened up several overseas offices to address the safety of imported food at 

the point of origin, and is testing a computer-based system to target high-risk 

Imports for additional inspection when they arrive at ports of entry. 

Specifically, in 2008, FDA inspected 153 foreign food facilities out of an 

esthnated 189,000 such facilities registered with FDA; in 2007, FDA inspected 

95 facilities. FDA eslhnated that it would conduct 200 inspections in 2009 and 

600 in 2010. In addition, FDA opened offices in China, Costa Rica, and lndia 

and expects to open offices in Mexico and Chile and to post staff at European 

Union agencies. Furthennore, FDA's testing of a new computer screening 

system-the Predictive Risk-Based Evaluation for Dynamic lmport 

Compliance Targeting (PREDlCT}-indicates that the system could enhance 

FDA's risk-based screening efforts at ports of entry, but the system is not yet 

fully operational. PREDICT is to generate a numerical risk score for all FDAregulated products by analyzing Importers' shipment infonnation using sets of 

FDA-developed risk criteria and to target for inspection products that have a 

high risk score. 

GAO previously identified several gaps in enforcement that could allow food 

products that violate saCety laws to enter U.S. commeree. For example, FDA 

has limited authority to assess penalties on importers who introduce such 

food products, and the lack of a unique identifier for !inns exporting food 

products may allow contaminated food to evade FDA's review. In addition, 

FDA's and CBP's computer systems do not share infonnation. FDA does not 

always share certain distribution-related infonnation, such as a recalling 

firm's product distribution lists with states, which Impedes states' efforts to 

quickly remove contaminated products from grocery stores and warehouses. 

GAO identified ceriain slatutory authorities that could help FDA in its 

oversight of food saCety. Specifically, GAO previously reported that FDA 

currently lacks mandatory recall authority for companies that do not 

voluntarily recall food products identified as unsafe. LImitations in FDA's food 

recall authorities heighten the risk that unsafe food will remain in the food 

suppiy. In addition, under current FDA regulations, companies may conclude 

a food ingredient is genernlly recognized as saCe without FDA's approval or 

knowledge. GAO recommended that, if FDA determines that it does not have 

the authority to Implement one or more recommendations, the agency should 

seek the authority from Congress. Finally, GAO reported that FDA has 

identified a need for explicit authority from Congress to issue regulations 

requiring preventive controls by !inns producing foods that have been 

associated with repeated instances of serious health problems or death. FDA 

already has preventive regulations for seafood and juice, which require firms 

to analyze safety hazards and Implement plans to address those hazards. 

______________ Unlted Statu Government ACCDuntabUily Office 
41 


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Mr. Chairman and Members of the Subconunittee: 

I am pleased to be here today to discuss findings from our work on the 

Food and Drug Administration's (FDA's) efforts to ensure the safety of 

imported food and on our other recently issued food safety work. 

According to U.S. Department of Agriculture (USDA) data, food imported 

from more than 150 countries and territories constitutes a substantial and 

increasing percentage of the U.S. food supply. imported food constitutes 

15 percent of the U.S. food supply, including 60 percent of fresh fruits and 

vegetables and 80 percent of seafood. Additionally, the volume of 

agricultural and seafood products imported for consumption increased 29 

percent from fiscal years 2003 to 2008, and the value of these products 

increased 65 percent. Ensuring the safety of imported food challenges 

federal agencies to better target their resources on the foods posing the 

greatest risks to public health and to coordinate efforts so that unsafe food 

does not enter U.S. commerce. 

We have reported on the safety of imported food for many years. In 1998, 

we assessed the federal government's efforts to ensure the safety of 

imported foods and determined that federal agencies could not be certain 

that the growing volume of imported food was safe for consumers.' More 

recently, we reported in September 2009 that agencies need to address 

gaps in enforcement and collaboration to enhance the safety of imported 

food.' Federal agencies involved in the oversight of food imports include 

the following: 

• FDA-which is responsible for roughly 80 percent of the food supply, 

including dairy products, seafood, fruits, and vegetables-oversees 

imported food safety through targeted inspections, sampling, and 

surveillance, among other things. Owing in part to the volume of imported 

products it regulates, FDA physically examines approximately 1 percent of 

imported food; however, the agency is developing the Predictive RiskBased Evaluation for Dynamic import Compliance Targeting (PREDICT) 

computer system to improve its targeted screening efforts. 

'GAO, Food Sa/ety: Federal EjJrms to Ensure the Sa/ely of Imported Foods Are 

Inconsistent and Unreliable, GAOIRCED·9g...103 (Washlngton, D.C,: Apr. 30, 1998). 

2GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboratirm to 

Enhance Safely of Imported Food, GAO.()9-873 (Washington, D.C.: Sept. 15,2009). 

Page 1 GAO-IO-699T 
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Customs and Border Protection (CBP), under the Department of 

Homeland Security, is responsible for inspecting food imports for 

compliance with U.S. law and coordinating with FDA to enforce food 

safety laws at the border, among other things. CBP's computerized 

screening system processes all imported shipments, including food. CBP 

requires importers to (1) give a manufacturer identification number for 

each imported shipment and (2) post a monetary bond for formal entries 

to provide assurance that these shipments meet U.S. requirements, among 

other things. 

USDA's Food Safety and Inspection Service (FSIS) has responsibility for 

the safety of imported meat and poultry and relies on an equivalency 

system whereby exporting countries must demonstrate that their systems 

meet standards that are equivalent to those of the U.S. system. 

Furthermore, food safety responsibility is further divided among the 50 

states, which may have their own statutes, regulations, and agencies for 

regulating and inspecting the safety and quality of food products. This 

fragmentation is the key reason that we added federal oversight of food 

safety to our high risk-series in January 2007 and called for a 

governmentwide examination of the food safety system.' 

Several food safety bills have recently been introduced in Congress, and a 

comprehensive bill, H.R. 2749, passed the House of Representatives in July 

2009. The House bill would require importers to register annually with 

FDA and to submit an appropriate unique facility identifier as a condition 

of such registration, among other provisions. The bill would also authorize 

FDA to issue a mandatory recall of foods that may cause serious adverse 

health consequences or death to humans or animals and would expand the 

agency's authority to assess criminal and civil penalties. Our September 

2009 report made some of the same recommendations. 

My testimony today will focus on three key issues: (1) FDA overseas 

inspections to address the safety of imported food, (2) identified gaps in 

agencies' enforcement that undermine efforts to ensure the safety of 

imported food, and (3) statutory authorities that we have identified that 

could help FDA's oversight of food safety. 

'GAO, HighrRisk Series: An Update, GAO.()7,110 (Washington, D.C.; January 2007). 

Page 2 GAO·IQ.699T 
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As detailed in our reports, we found the following: 

First, while the number of FDA's foreign inspections has fluctuated, the 

agency has opened several overseas offices to address the safety of 

imported food at the point of origin. In addition, FDA testing of PREDICT 

indicates that the system could enhance FDA's rtsk-based screening 

efforts, but the system is not yet fully operational. FDA officials stated that 

a scheduled nationwide rollout this summer of PREDICT has been delayed 

primarily because of technical problems, such as server crashes and 

overloads, which are affecting FDA's field data systems nationwide. 

• Second, gaps in FDA's and other agencies' enforcement could allow 

violative food products to enter U.S. commerce. For example, FDA has 

limited authority to assess penalties on importers who introduce violative 

food products, and the lack of a muque identifier for firms exporting food 

products may allow contaminated food to evade FDA review. 

• Finally, we have made several recommendations that would help FDA 

improve food safety oversight. For example, we recommended that FDA 

seek additional authorities, such more explicit authority to create 

preventive controls for high-risk foods, and we have recommended that 

Congress consider giving FDA additional authority, such as mandatory 

recall authority. FDA agreed with our recommendations and has sought 

authority to order food safety recalls and issue additional preventive 

controls for high-risk foods. 

This testimony is largely based on our September 2009 report on imported 

food safety, as well as other recent reports, and updated with information 

from FDA. See appendixes HV for highlights of our prior work. We 

conducted our work in accordance with generally accepted government 

auditing standards. 

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While the Number of 

FDA Overseas 

Inspections Has 

Fluctuated, the 

Agency Has Opened 

Overseas Offices, and 

Has Piloted PREDICT 

In 2008, FDA inspected 153 foreign food facilities out of an estimated 

189,000 such facilities registered with FDA and estimated that it would 

conduct 200 Inspections In 2009 and 600 In 2010.' In 2007, FDA inspected 

95 facilities. Table I shows the number of FDA inspections of foreign food 

facilities, by country, from fiscal years 2001 through 2008. As the table 

shows, FDA conducted 1,186 inspections in 56 countries from fiscal years 

2001 through 2008; the majority of FDA inspections were In Mexico, 

followed by Ecuador, Thailand, and Chile. FDA conducted a total of 46 

Inspections in China during this period. 

IFDA was not able to provide 2009 inspection data in time for this statement, according to 

FDA officials. 

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Table 1: FDA Inspections Of Food Firms in Foreign Countries, Fiscal Years 2001 through 2008 

2001 2002 2003 2004 2005 2006 2007 2008 Total 

Mexico 17 15 15 7 16 26 29 133 

Ecuador 8 0 11 24 0 11 10 64 

Thailand 4 10 0 10 22 0 12 58 

Chile 13 15 11 0 5 57 

Peru 13 0 18 1 9 9 4 54 

Brazil 0 12 7 21 0 0 53 

China 0 9 16 0 13 46 

Taiwan 9 0 0 7 39 

Canada 13 13 1 0 38 

Costa Rica 0 11 0 4 5 34 

Honduras 9 8 0 0 32 

Vietnam 0 9 10 0 31 

Argentina 7 5 0 0 19 0 31 

India 6 0 10 0 0 30 

South Korea 14 0 6 28 

Australia 12 0 0 27 

Jamaica 2 0 3 0 22 

Nicaragua 8 0 0 7 0 4 

EI Salvador 0 0 0 0 18 

Germany 5 4 4 0 1 17 

Estonia 8 0 8 0 0 16 

Panama 0 0 0 0 0 16 

South Africa 11 0 0 0 0 16 

Malaysia 0 0 0 9 0 15 

28 additional countries· 

Total number of cQuntries that had firms Inspected 

by FDA during the speelflc fiscal year listed above 26 22 22 20 16 15 11 24 56 

Total inspections 211 169 148 153 132 125 95 153 1.186 

SOU!e&: GAO analysI9 of FOA data. 

'Countries with a total of 14 or fewer inspections between 2001 and 2008 are not listed in the table. 

These countries include: Italy (14 inspections), latvia (14), Uruguay (14), Venezuela (14), Morocco 

(13), New Zealand (13), Poland (13), Trinidad and Tobago (12), Franca (11), Norway (11), Romania 

(10), Surinam (10), lcaland (9), Bulgaria (a),C%mbla (a), United Kingdom (8), Cyprus (7), Turkey (5), 

BeliZ8 (4), Spain (4), Belgium (3), Greece (3), Hungary (3), Indonesia (3), Finland (2), Haiti (2), Japan 

(2), and the Netherlands (2). 

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For fiscal year 2009, FDA allocated 272 full-time employees to examine 

imported food shipments at U.S. ports of entry and estimated a budget of 

approximately $93.1 million for field import activities.' The total estimated 

2009 FDA budget for all FDA products and programs, including food, 

drugs, medical devices, and other products, was $2.7 billion. In 2008, we 

testified that if FDA were to inspect each of the 189,000 registered foreign 

facilities-at the FDA Commissioner's estimated cost of $16,700 per 

inspection-it would cost FDA approximately $3.2 billion to inspect all of 

these facilities once.' 

Since November 2008, FDA has opened overseas offices to help prevent 

food that violates U.S. standards from reaching the United States. These 

offices are expected to provide FDA with direct access to information 

about foreign facilities' food manufacturing practices so that its staff at 

U.S. ports of entry can make more informed decisions about which food 

imports to examine. For example, FDA's overseas staff are working with 

staff at counterpart regulatory agencies overseas, as well as with other 

stakeholders who may be knowledgeable about certain industries. 

Overseas staff are also educating local exporters to make sure they 

understand U.S. food safety laws and regulations and FDA expectations. 

FDA opened offices in China (Beijing, Guangzhou, and Shanghal); in 

Europe (Brussels, London, and soon in Parma, Italy); in Latin America 

(San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico); and in 

India (New Delhi and Mumbai). The FDA Middle East Office is operating 

out of FDA headquarters because the Department of State denied its 

request to locate in Amman, Jordan, due to security concerns. 

In addition to having overseas offices assist FDA's oversight of imported 

food, the agency is developing PREDICT. PREDICT is intended to assist 

FDA's oversight of imported food and uses FDA-developed criteria to 

estimate the risk of imported food shipments. These criteria are to 

incorporate, among other things, the violative histories of the product, 

importer, manufacturer, consignee, and country of origin; the results of 

laboratory analyses and foreign facility inspections; and general 

~is category includes all nonlaboratory activities, such as field examinations and tests, 

import sample collections, import label exams, Prior Notice Center security reviews, 

import entry reviews, and other import investigations, as well as associated infrastructure 

support. 

eGAO, Federal Oversight of Food So/ety: FDA has Provided Few Details on the Resources 

and Strategies Needed to Implement Its Food Protection Plan, GAO..(}8-909T (Washington, 

D.C.: June 12, 2008). 

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intelligence on recent world events-such as natural disasters, foreign 

recalls, and disease outbreaks-that may affect the safety of a particular 

imported food product. In addition, agency officials stated that PREDICT 

will assign higher risk scores to firms for which the system does not have 

historical data. 

PREDICT generates a numerical risk score for all FDA-regulated products. 

According to FDA, PREDICT is to present the shipment's risk score to 

FDA reviewers if the score is above an FDA-specified threshold. 

Shipments that are below the threshold are to receive a system "may 

proceed" (cleared) message unless other conditions are present, such as 

an FDA import alert.7 FDA intends that reviewers using PREDICT will also 

be able to view the specific risk factors that contributed to the shipment's 

risk score, such as whether the product or importer has a history of FDA 

violations. FDA expects reviewers to use PREDICT to supplement, rather 

than replace, their professional judgment when deciding what food 

products to inspect. 

A 2007 pilot test of PREDICT in Los Angeles for seafood products 

indicated that the system could enhance FDA's risk-based import 

screening efforts. When compared with baseline data from FDA's existing 

import screening system, the Operational and Administrative System for 

Import Support (OASIS), PREDICT improved FDA's ability to target 

imports that the agency considers to be high risk for further examinations 

and allowed a greater percentage of products the agency considers to be 

low risk to enter U.S. commerce without requiring a reviewer's 

intervention. Specifically, PREDICT nearly doubled the percentage of field 

examinations--and increased by approximately one-third the percentage 

of laboratory examinations-that resulted in violations, relative to 

baseline OASIS data In addition, according to FDA, the violations in 

shipments that reviewers targeted using PREDICT, on average, posed a 

greater risk to human health than the violations that OASIS detected. 

FDA told us on April 12, 2010, that PREDICT is fully operational in the Los 

Angeles and New York districts, but due to technical problems, FDA has 

not determined when the system will be deployed in the Seattle district. In 

7[mport alerts communicate information and policy to FDA field staf:f: Usually, they provide 

infonuation that products covered by the alert are subject to detention. If a product is 

detained, the importer is provided an opportunity to prove that the imported product is 

compliant, such as by providing FDA with the results of third~party laboratoIj' analysis of 

the product 

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FDA and Other 

Agencies Face Gaps 

in Enforcement That 

Undermine Efforts to 

Ensure the Safety of 

Imported Food 

FDA Has Limited Authority 

to Ensure Importers' 

Compliance 

addition, FDA officials stated that a scheduled nationwide rollout of 

PREDICT this summer has been delayed, primarily because of technical 

problems, such as server crashes and overloads, which are affecting FDA's 

field data systems nationwide. 

Although the PREDICT pilot produced positive results and demonstrated 

the system's potential to improve import screening efforts, we reported 

that further agency actions were needed to help ensure that the system is 

effective. For example, FDA had not yet developed a performance 

measurement plan to evaluate, among other things, PREDICT's ability to 

identify high-risk shipments for manual review while simultaneously 

returning "may proceed" messages for low-risk shipments and enabling 

them to enter U.S. commerce. We recommended FDA develop such a plan. 

According to agency officials, since our report was issued in September 

2009, FDA had completed a draft performance measurement plan. 

However, we have not reviewed this draft plan. 

We identified specific gaps in enforcement that could allow violative food 

products to enter U.S. commerce: (1) FDA's limited authority to assess 

civil penalties on certain violators; (2) lack of unique identifiers for firms 

exporting FDA-regulated products; (3) lack of information-sharing 

between agencies' computer systems and (4) FDA's not sharing product 

distribution information during a recall. 

Importers can retain possession of their food shipments until FDA 

approves their release into U.S. commerCe. However, FDA and CBP 

officials do not believe that CBP's current bonding procedures for FDAregulated food effectively deter importers from introducing violative food 

products into U.S. commerce. Specifically, importers post a monetary 

bond for formal entries (i.e., all shipments exceeding $2,000 and certain 

shipments valued below that amount) to provide assurance that these 

shipments meet U.S. requirements. According to these officials, many 

importers still consider the occasional payment offorfeited bonds as part 

of the cost of doing business. Indeed, as we reported in 1998, forfeiture of 

the shipment's mrudmum bond value is often not sufficient to deter the 

sale of imported goods that FDA has not yet released. in its response to 

our September 2009 report, FDA agreed with this finding. According to 

FDA's regulatory procedures manual, the bond penalty is intended to 

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FDA and CBP Do Not 

Provide Unique 

Identification Numbers to 

Finns 

make the unauthorized distribution of articles unprofitable, but liquidated 

damages incurred by importers are often so small that they, in effect, 

encourage future illegal distribution of imported shipments. Even though 

the bond may be up to three times the value of the shipment, for a large 

importer, this sum may be negligible, especially when the importer 

successfully petitions CBP to reduce the amount. 

We recommended that the FDA Commissioner seek authority from 

Congress to assess civil penalties on firms and persons who violate FDA's 

food safety laws and that the Commissioner determine what violations 

should be subject to this new FDA civil penalties authority, as well as the 

appropriate nature and magnitude of the penalties. FDA agreed with this 

recommendation and was working with Congress to include civil penalty 

authority in food safety legislation. FDA officials also told us that if the 

agency had the authority to impose civil penalties on importers, which is 

also provided for in H.R. 2749, FDA might be better able to deter 

violations. 

High-risk foods may enter U.S. commerce because the identification 

numbers that FDA uses to target manufacturers that have violated FDA 

standards in the past are not unique, and therefore these manufacturers 

and their shipments, may evade FDA review. Importers generate a 

manufacturer identification number at the time of import, when, among 

other things, they electronically file entry information with CBP. (CBP is 

responsible for validating the manufacturer identification numbers and 

ensuring they are unique.) CBP electronically sends this information to 

FDA's computer system. From this new manufacturer identification 

number, FDA's computer system automatically creates an FDA firm 

identification number-called the FDA establishment identifier. Officials 

told us that a single firm may often have multiple CBP manufacturer 

identification numbers-and therefore multiple FDA establishment 

identifiers. FDA officials told us that because CBP has multiple 

identification numbers for many firms, FDA has an average of three 

'unique" identifiers per firm, and one firm had 75 identifiers. 

The creation of multiple identifiers can happen in a number of ways. For 

example, if information about an establishment-such as its name-is 

entered by importers incorrectly at the time of filing with CBP, a new 

manufacturer identification number, and therefore a new FDA 

establishment identifier, could be created for an establishment that 

already has an FDA number. In this scenario, an importer mayintentionally or unintentionally~nter a fum's name or address slightly 

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differently from the way it is displayed in FDA's computer system. This 

entry would lead to the creation of an additional FDA number for that 

firm. If an import alert was set using the original FDA establishment 

identifier, a shipment that should be subject to the import alert may be 

overlooked because the new number does not match the one identified in 

the alert. 

In addition, foreign facilities that manufacture, process, pack, or hold food 

for consumption in the United States, with some exceptions, are required 

to register with FDA Upon registration, FDA assigns a registration 

number. FDA calculated that in 2008, 189,000 foreign firms were registered 

under this requirement. However, some of the firms included in that total 

may be duplicates because the facility may have been reregistered without 

the cancellation of the original registration; consequently FDA may not 

know the precise number of foreign firms registered. As we previously 

reported, FDA officials told us they are working to address the unique 

identifier problem by establishing an interactive process in which FDA's 

systems recognize when a product's identifier does not match its 

manufacturer's registration number. 

As we reported, FDA could consider requlrlng food manufacturers to use a 

unique identification number that FDA or a deSignated private sector firm 

provides at the time of import. However, the use of this unique number 

would necessitate collaboration with CBP, since importers would use such 

a number each time they file with CBP to ship goods to the United States. 

That is, CBP's computer system would need to be progranuned to accept 

an FDA unique identification number. According to CBP officials, it is 

unknown if or when CBP's system will have this capability. To improve 

FDA's and CBP's ability to identify foreign firms with violative histories, 

we recommended that the FDA Commissioner explore ways to improve 

the agency's ability to identify foreign firms with a unique identifier and 

that the CBP Commissioner ensure that its computer system is able to 

accept a unique identification number for foreign firms that export FDAregulated foods. Both FDA and CBP agreed with our recommendation, and 

CBP officials told us that the agency has developed a plan for 

implementing a unique identifier. However, we have not reviewed this 

plan. We observe that H.R. 2749 contains a provision that may allow the 

Secretary of Health and Human Services, in consultation with the 

Commissioner of CBP, to specify the unique numerical identifier system to 

be used, taking into account compatibility with CBP's automated systems. 

Such actions would help prevent high-risk foods from entering U.S. 

commerce. 

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Infonnation Is Not Shared 

between Computer 

Systems 

When we issued our report in September 2009, we reported that CBP's 

computer system did not notify FDA's or FSIS's systems when imported 

food shipments arrive at U.S. ports, which increases the risk that 

potentially unsafe food may enter U.S. commerce, particularly at truck 

ports. If FDA chooses to examine a shipment as part of its admissibility 

review, the agency notifies both CBP and the importer through its 

computer system, OASIS. However, once the shipment arrives at the port 

and clears CBP's inspection process, the importer is not required to wait at 

the port for FDA to conduct its examination. instead, the importer may 

choose to transport the shipment to the consignee's warehouse or other 

facility within the United States. The importer might choose to do so 

because, for example, CBP and FDA do not have the same hours of 

operation at some ports, and FDA's port office may be closed when the 

shipment arrives. In such cases, as a condition of the bond with CBP, the 

importer agrees to hold the shipment intact and not distribute any portion 

of it into U.S. commerce until FDA has examined it. 

CBP and FDA officiais told us that, occasionally, an importer will 

transport the shipment to the consignee's warehouse without first 

notifying FDA. If this occurs, FDA will not quickly know that the shipment 

has arrived and been transported to a U.S. warehouse because CBP's 

computer system does not notify FDA's OASIS computer system when the 

shipment arrives at the port. instead, from the perspective of an FDA 

reviewer using OASIS, it will appear as if the shipment's arrival is still 

pending. FDA port officiais told us that it could be 2 or 3 days before FDA 

reviewers become suspicious and contact CBP to inquire about the 

shipment's arrival status. By this time, an unscrupulous importer could 

have distributed the shipment's contents into U.S. commerce without 

FDA's approval. As we reported, if CBP communicated time-of-arrival 

information directly to OASIS, then FDA would be able to quickly identify 

shipments that are transported into the United States without agency 

notification and arrange to examine them before they are distributed to 

U.S. markets. Since our report was issued in September 2009, CBP told us 

that it had modified its software to notify FDA of a shipment's time of 

arrival. However, we have not reviewed the effectiveness of these 

modifications. We are still waiting to see whether CBP has an agreement 

with FSIS regarding time of arrival modifications. 

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FDA Does Not Always 

Share Product Distribution 

Infonnation During a 

Recall 

One key issue of concern, according to officials we spoke with from 

several states, is that FDA does not always share with states certain 

distribution-related information, such as a recalling finn's product 

distribution lists, which impedes the states' efforts to quickly remove 

contaminated products from grocery stores and warehouses. According to 

one state official, because FDA does not provide this infonnation, the state 

has to spend time tracking it down on its own. Public health may be at risk 

during the time it takes for the states to independently track distribution 

information when a product is found to be contaminated. FDA told us that 

it usually considers such information to be confidential commercial 

information, the disclosure of which is subject to statutory restrictions, 

such as the Trade Secrets Act. However, FDA's regulations allow for 

sharing of confidential commercial information with state and local 

government officials if, for example, 

Statutory Authorities 

We Identified Could 

Help FDA Oversee 

Food Safety 

• the state has provided a written statement that it has the authority to 

protect the infonnation from public disclosure and that it will not further 

disclose the information without FDA's permission, and FDA has 

determined that disclosure would be in the interest of public health, if 

such sharing is necessary to effectuate a recall, or 

the information is shared only with state and local officials who are duly 

commissioned to conduct examinations or investigations under the 

Federal Food, Drug, and Cosmetic Act. In certain circumstances, FDA may 

also seek a finn's consent to disclose its market distribution infonnation. 

In our past work, we have pointed out that mandatory recall-the 

authority to require a food company to recall a contaminated productwould help ensure that unsafe food does not remain in the food supply. 

We also reported that FDA should strengthen its oversight of food 

ingredients determined to be generally recognized as safe for their 

intended use and to seek the authority if the agency deems necessary. 

Likewise, we reported that FDA has identified a need for explicit authority 

from Congress to issue regulations to require preventive measures by 

firms producing foods that have been associated with repeated instances 

of serious health problems or death. 

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FDA Lacks Mandatory 

Recall Authority 

We have reported that food recalls are largely voluntary and that federal 

agencies responsible for food safety, induding FDA, have no authority to 

compel companies to recall contaminated foods, with the exception of 

FDA's authority to require a recall for infant formula,' FDA does have 

authority, through the courts, to seize, condemn, and destroy adulterated 

or misbranded food under its jurisdiction and to disseminate information 

about foods that are believed to present a danger to public health, 

However, government agencies that regulate the safety of other products, 

such as toys and automobile tires, have recall authority not avallable to 

FDA for food and have had to use their authority to ensure that recalls 

were conducted when companies did not cooperate, 

We have noted that limitations in the FDA's food recall authorities 

heighten the risk that unsafe food will remain in the food supply and have 

proposed that Congress consider giving FDA similar authorities. H.R. 2749 

authorizes the Secretary of Health and Human Services to request that a 

person recall an article of food if the Secretary has reason to believe it is 

adulterated, misbranded, or otherwise in violation of the Federal Food, 

Drug, and Cosmetic Act and to require a person to cease distribution if the 

Secretary has reason to believe the article of food "may cause serious 

adverse health consequences or death to humans or animals," It also 

requlres the Secretary to order a recall of such an article of food if the 

Secretary determines (after an informal hearing opportuulty) it is 

necessary. Finally, it authorizes the Secretary to proceed directly to a 

mandatory recall order if the Secretary has credible evidence that an 

article of food subject to an order to cease distribution presents an 

imminent threat of serious adverse health consequences or death to 

humans or animals. As our previous work has shown, mandatory recall 

authority would allow FDA to ensure that unsafe food does not remain in 

the food supply. 

SGAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls 

of Potentially UnsaJe Food, GAO-O,,51 (Washington, D.C.: Oct. 6, 2004) and GAO, Federal 

Oversight oj Food Safety: High Risk Designation Can Bring Attention to Limitations in 

the Federal Government's Food Recall Programs, GAO-07-7S5T (Washington, D.C.: Apr. 24, 

2007). 

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FDA Has Limited 

Oversight of Food 

Ingredients Determined to 

be Generally Recognized 

as Safe 

We have reported that FDA should strengthen its oversight of food 

ingredients detennined to be generally recognized as safe (GRAS) for their 

intended use.' Manufacturers add these substances-hundreds of spices 

and artificial flavors, emulsifiers and binders, vitamins and minerals, and 

preservatives-to enhance a food's taste, texture, nutritional content, or 

shelf life. Currently, companies may conclude a substance is GRAS 

without FDA's approval or knowledge. We reported that FDA only reviews 

those GRAS determinations that companies submit to the agency's 

voluntary notification program. The agency generally does not have 

information about other GRAS determinations companies have made 

because companies are not required to inform FDA of them. Among other 

things, we recommended to FDA that it develop a strategy to require any 

company that conducts a GRAS determination to provide the agency with 

basic information about this detennination, and to incorporate such 

information into its public Web site. 

We also reported that FDA is not systematically ensuring the continued 

safety of current GRAS substances. According to FDA regulations, the 

GRAS status of a substance must be reconsidered as new scientific 

information emerges, but the agency has not systematically reconsidered 

GRAS substances since the 1980s. Rather, FDA officials said, they keep up 

with new developments in the scientific literature and, on a case-by-case 

basis, information brought to the agency's attention could prompt them to 

reconsider the safety of a GRAS substance. We recommended that FDA 

develop a strategy to conduct reconsiderations of the safety of GRAS 

substances in a more systematic manner. We also recommended that, if 

FDA detennines that it does not have the authority to implement one or 

more of our recommendations, the agency should seek the authority from 

Congress. FDA generally agreed with the report's findings and 

recommendations. 

In addition, we reported that FDA has taken steps to make information 

about its GRAS notification program avallable to the public by posting its 

inventory of all GRAS notices FDA has received on its Web site. By placing 

information about the GRAS notice and its response on its Web site, FDA 

enhances the ability of Congress, stakeholders, and the general public to 

be better informed about GRAS substances. H.R. 2749 contains provisions 

on GRAS substances, including a requirement that the Secretary post on 

GGAO, Food Safety: FDA Slwuld Strengthen Its Oversight oj Food Ingredients Detennined 

to Be GeneraUy Recognized as Safe (GRAS), GAO-lO·246 (Washington, D.C.: Feb. 3, 2010). 

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FDA Lacks Explicit 

Authority to Issue 

Regulations Requiring 

Food-Producing Finns to 

Institute Preventive 

Measures 

FDA's Web site information about GRAS notices submitted to FDA within 

60 days of receipt of the notice. 

We have also reported that FDA should strengthen its oversight offresh 

produce." For example, we noted that FDA has identified a need for 

explicit authority from Congress to issue regulations requiring preventive 

controls (risk-based safety regulations) by firms producing foods that have 

been associated with repeated instances of serious health problems or 

death. FDA already has preventive regulations for seafood and juice, 

which require firms to analyze safety hazards and implement plans to 

address those hazards. According to FDA, such authority would 

strengthen the agency's ability to implement risk-based processes to 

reduce illnesses from high-risk foods. FDA officials told us that issuing 

preventive regulations may be one of the most importaut things they can 

do to enhance their oversight of fresh produce. We therefore 

recommended that the Commissioner of FDA seek authority from 

Congress to make explicit FDA's authority to adopt preventive controls for 

high-risk foods. FDA agreed with this recommendation and has sought 

authority to issue additional preventive controls for high-risk foods. 

Furthermore, RR. 2749 requires FDA to create preventive controls for 

produce and certain raw agricultural commodities. Such measures could 

help the agency reduce illnesses from these high-risk foods. 

In conclusion, food imports from around the world constitute a substantial 

and increasing volume of imported foods. Our work has shown that FDA 

could strengthen its oversight of imported food by improving its 

enforcement, such as by assessing civil penalties and providing unique 

identification numbers to firms. Additional statutory authorities, such as 

mandatory recall authority, could also help FDA oversee food safety. FDA 

generally agreed with our recommendations and has some taken actions 

to address them. 

Mr. Chairman, this concludes my statement. I would be pleased to answer 

any questions that you or other Members of this Subcommittee may have. 

lOGAO, Food Sa/ely: Improvements Needed in FDA Oversight of Fresh Produce, 

GAO-08-IO,17 (Washington, D.C., Sept. 26, 2008). 

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Contact and Staff 

Acknowledgments 

For further infonnation about this testimony, please contact Lisa Shames 

at (202) 512-3841 or shamesl@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on ihe last page 

of this statement. 

Key contributors to this statement were Jose Alfredo Gomez, Assistant 

Director; Kevin Bray; Candace Carpenter; Anne Johnson; Carol Herrnstadt 

Shulman; Nico Sloss; and Rebecca Yunnan. 

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Appendix I: GAO-09-873 (Food Imports) 

! GAO Ii ........... 

HigbJj~ 

Why GAO DldThI. Study 

Imported food makes up a 

!fUbsQwtial and gro1V1ng portion of 

the U.s' rood supply. To ensure 

importedfoodsal ... ty,feOOrl'll 

~nciE!!l mUBtf0CU5th.eir 

resouteeIJ on high risk foods and 

coordinateeJ!om. 

lnthbamt.ext, GAO Wa.'J 3Ilke4 to 

(l)~howCustomsand 

Border ProtEdiOll (CBP), the Food and Drug Administntion (FDA). 

andtl\eU.s.Departn\ento! 

Agrteulture', (USDA'II) Food Safety 

and fnspectionServlce (FSIS) are 

addre!!sing challenges m 

ovenJeeingtf!esaletyofimported 

tood;{2) ~hawFDAje~rages 

«sourcesb.,worldrIiwi!hother 

('ntitlU,wclI:asstatelllldfn~ign 

goveromen~ and (3) detenn.ifle 

how FDA is usinlJ its Predictive 

Risk-Based Evaluation (or Dynamic 

lmpoctCompiWlee ~tmg 

(PREDICT)systemklow~ 

Imported food safety. GAO 

.analywt CSP, FDA, and FSIS 

P~R'POrtS,.;md 

reguiadootJ and interviewed agency offlcials1Uldkey~holdel'$. 

iWiMlifi·'·1QMi,ji"g,i.M 

GAO!"eCOIMlends,amoogot:her 

thlngs,thatFDA9te"kautl;!ority 

from the Congreu to aseessl!lV\l 

penall,ies on I1nns and pef'lMlM who 

viollUe FDA Ia"" and that the rnA 

COl!\Jll1S8loner explore waY' to 

lmplll\"et.beagency'l!IabilltytQ 

identity torelgn tInns wtth a unique 

lrlt-ntitter. CBP and FDA genf!rally agreed with (lUI' recommendations. 

fSISprov1dt!dtedmlcalco~n'" 

oruy. 

V_GAO-<lU71"'~"Yecmpo_ 

F""mIIi'.fn/QmlaUOll.~\;U~at 

(202}S12"3&4I()f>hame!I"g.ao.';tCIy 

Page 17 

FOOD SAFETY 

Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food 

What GAO Found 

CBP, FDA, and FSIS have taken step!'! to addre&ol challenges in ensuring llie 

safety ofilie increa!llng yolume of imported food. For example, CBP rnaint.a1ns 

the system that importers use to provide information to rnA on food 

shipments; FDA electronicalty reviews food imports and ireJpectS some 

fort'ign food production facilIties to prevent vio!.atiye food from reaching U.S. 

shores; and FSIS employs an equivnleney system that requires eountries to 

demonst:rnte that their food safety ~mlJ provide the.same If'Yelof 

protection lIS the U.S. !JYStem. However, ~ in enforcement and 

t'Ollahorntion undermine these efforta First, CDP'lJ computer syste-m does not 

currently notify FDA or FSlS when imported food :'Shipment!! arrive at US. 

ports, although elTmts are underway to provide this infOnTIabOIl to FDA lor 

alr and truck slupmentA This lack of communication may potenttalJy increase 

the risk that utJ.lI;I!e food couid enter U.& commerce Wlthout FDA review, 

particularly at truck porta. Set:Olld, FDA h3!l limited authority to ensure 

importel'3' (Xlmpliance with it.s regulations. Third, CBP and FDA do not 

identify importem with a unique number; as a result, FDA .... annot always 

~food shipments originating from high risk importers. Flna1Iy, CBP fluoe5 

chaUenga in managing in-bond sltipmf!nts--those that. move witlull the 

United ~ without Connally entering U.S, comm~e-and such shlpments 

po$ibly could be diverted mto commerce. 

FDA generatlyC(lUabornte! with seiect.sUlWs and foreign governments on 

imported food 53iety. FDA has entered into a contr:act, Sl'V{lral cooperative 

~ments, and informal partllerships Cor imported food With certain atates, 

and some state officials told GAO that Ihey would tike to rollaborate further 

with FDA on food Imporu. However, citing lega! restrictions, F'DAdoe$ not 

fully sharecertain informaUon, such a1I product distribution lists, with 3Wes 

(filling a recalL TIll! improll\ll staI;e!t;' efforts to qwckly remove contaminated 

produ.d:! from grocery stDrt!!I and ~hoU.'leS. fo""SlS has begun to make 

.available to the public a fist of retail est.abllshments that have likely received 

food productsthat am subject to a seriotJ.<j recalL FDA is aJso. expanding 

efforts to wordinai.e with oti\e£ countries. In particular, through il$ Beyond 

Our Bordel'S ini~, FDA intends to station inVf:'!:ltigatOrs and technical 

<;,xperts III China, Europe, and lndia, 10 provide tedmical assistance and 

gather information about rood manufacturing prnct.ices to improve ~k-based 

sneening alU.S. ports. 

Accofding to FDA, PREDICT will anaI.yre food shipments Wllng criteria that 

include a product'lJ inherent rood sat'ety risk and the importer'., Vlo.la.tlve 

histolY, among other thblgoJ. to estinulle each shipment's risk. A 2007 pilot \:.e!!t 

of PREDICT indicated that the s)'Stem improved fDA's abtlity to identlty 

products" considers to be high risk while allowing a greater percentage ot 

product! it considem!ow risk to enter u.s. comm1:'n:e without a manual 

review. However, FDA h!19 not yet developed a plan to measure the system's 

p11r!onnance, and GAO previously Identified shortcomIng, in FDA's 

informatlon technology modernization efforts. fDA plarul to begin deploying 

PREDICT at all pons and for all FDA-regulated product! In September 2009, _________ U"It~St_..o-~A~O!'I\c$ 

GAO-IO-699T 
58 


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Appendix II: GAO-07 -785T (Food Recalls) 

Why GAO Dld'lllio Study 

F.adt year, a.OOut 16 milJron people 

cofltt:lct a loodbome UIneas in the UnIred~3bout326,OOO 

~ hoopita1ization; and about 

5,OOOdle.~outbttakso!E.roli 

InsptnachandSalmoneUa.Jn 

peMutbu/.ter,aloogwtth 

contammation in pet tooct.llage 

highlighted the rls.b poaed by 3I:Cldentalfoodcontamination. 

'l1te0ltacbofSepternbUll,2001, 

helgttteneda~that!lwrcod 

supply could ai-.o be vulnmlble to 

deUbomIt.econtMlJnation.'ThiIJ 

testimony tOCl.lSe$OO the (1) ro!e 

thatGAO·$~Mrt.!eeanpla1 

In I'1Iisingthe priority andVisibIfity 

of the n('ed toll'llNConn federal 

~l!J!ghlorfoodsafety.(2) 

fragmented~otfederal 

~to(toodsate1;y. and(3) 

limitattOll5lnredert!lfood~ p- ''dMiif.1''.'g;.ii,i,il§,j·tW 

While many ofOAffiI ff-commend:a.t:l.otopl1.'lmOte-tM 

~ ofUle NtbI.'s food 5UJIp\J 

haVf!beenactedllpO\.other$baYt! 

nctyet~~For 

e:Eample,GAO~thl¢ 

the euatl.iVe branch rel!C!:wenetl'le 

i"resident'l Council on Food Safet;1 

to!Killtateinte~ 

coordhW:Ion.GAOaaop~ 

thu CmIgres11 enact 

oomptthen5tve, uniform, and risk· 

ba8edtoodsatttyltg1s1at1m;-

~a1ttomJt1veorgani%ational 

roodMfet;y~and 

con.sIder!egl.!latWr!g:lvIng~dal 

authorit;ytoocdertood~ 

_.gacQCl¥~~QAO-()l·1!)ST. 

To"""'IhtIul~~1IIf1Clopol 

and~,dldlonlMlink~ 

FOf!OONWor","o".~\.lu~'" 

(202)iU:z.3&4ilor~Ooao·gO\l· 

Page 18 

FEDERAL OVERSIGHT OF FOOD SAFETY 

High-Risk Designation Can Bring Needed 

Attention to Limitations In the 

Government's Food Recall Programs 

What GAO Found 

GAO's Higt\-R1ak Serie!! is intended tora1se the priority and risibility of 

government programs that are m need of IJroad·based trnnsfonnation to 

achieve greater economy, el'ftciency, effectiveness, accountability, and 

~illty. The5e reports aI:so help Col1gre5ll and the executive bmnch 

('.any out their responaibilities while improvillg the government's 

performance and enhancing its acoountability for the benefit of the 

American people. In Janwuy 2007, as partof our regular update of this series 

for each MWCOngress. GAO designated the r~ral ovemght of rood satei.)' 

as ahigtHisk area far the flr.Jt time, 

We designated federal oversight of tood safety as ahiglHisk area becaWie of 

the need to b:Wl$lonn this system to rerluce risks to public heaJth as weB .as the economy, While-this nation enjoys a plentiful and varied food supply that 

is genernUy eOMldered to be safe, the fed-end over.Jight ot food safety is 

fragmented, with 15 agencies coUectively adminl$tering at least :lO la_ 

related to lood safety. 'I'he two prinwy agencie!lll are the U.S, Oepartmento( 

Agricultuxe (USDA), which is responsible for the $\Cety of meat,. J)OU.ltfy, and 

prnceseed egg products, and the Food and Drug Adrninisttatlon (FDA), 

whlchis n'$ponsible forvirtually 311 ollieflood. We have identified 

examples where the fooeral govemmenl'9 resottreeS and enfmcement 

activitle5 can better align with flle mIG orrood contaml.naUon. For enmlt:l1e, 

the ml\iority of federal expendihu'e9 for food safety inspection were dired:ed 

toward USDA's pr'1:lgl'am!l for ensuring the safety of meat, poultry, MId egg 

products; however, USDA b responsible for regulating nnIy about ZO percent 

of the food supply. In contnlst, FDA, which is respo11Sible for regulating 

about 80 pere(!nt of the Cood supply, acCQunte<i. (or only ahQut 24 pefC(!nt of expenditures. 

Among the n!~ we desIgnated federal ovCfflight ot toodsatety Ma highrisk area is that limitations in the feder3! go~nunent'.s tood recalls heighten 

the risk that un.we food will remain m flle food supply and ultltnately be 

con:rumed. Food recalI5 are voluntary, and federal agencies responsible tor 

food s;J/ety have no IWtbOrit)' to compel companies!o carry out recallswith the exception of FDA's authontJ to reqUire a recall tor InfMt (omula. 

eSDA and FDA provided guidance tor comp.anies to carry out volunw, 

re<'.alJ& We ~ reported that USDA and fDA could doa better job carrying 

oot their food recall programs !lIO they can quickly remove potertt::iall7 tlM3!e 

rood (rom the marketplace. At the tim!! of our review, these agencies did not 

know how promptly and completely companiCll were carrying out recalJs, 

did not promptly verity that tee. had reached all segmenl3 ot ttl!! 

dl'ltribution dwJI, and u.'Ied procedures that may not haW! been effective to alertcol't!llUHlerstoarecaU. 

_________ UnitedStatMaov.mm.ncAeQDUFlf.lll:ljIIfyOflb 

GAO-I0-699T 
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Appendix III: GAO-IO-246 (GRAS) 

HloJ'lI!IrtSoIGA()'\O·24&,affll'OrtlO -,---

Why GAO Old this Study 

The Food and Drug Adminl'ltration 

{FDA}. whlch is 1'e:Sf)O!I8ibh! for 

ensuring thesahlty oCmOBtotthe 

tl.s. rood9Upply, isnot required to 

n;viewsubstances,sucitasS))iees 

and p~se~, added w food 

thatazegenerallyrecogni2edall 

safe (GRAS) (or their iotended use. 

Cumntly, compani$ may 

deU!nnine a subswlce is GRAS 

without FDA's appl'QW:J Of!' 

knowledge. Howt'!'VtT, arew 

su~pI'I'lviouslyconsldered 

GRAS ha~ later been banned; and 

coocems ha~ been niliedabout 

~S!lety<1f<lllu!rGRAS 

substances,lncludlngtlmse 

1'000tainlngengl.nee~ 

nanomateriab, malertab 1'1W'Iufacture<! 31attny scale to take 

advantage of novel prope«le$. GAO 

was asked to review thee.rtentto 

which (J) FDKsovetsightof~w 

GRAS detemUnatioJl!.he!ps ensure 

the98t'et)'ortbesesu~(2) 

FDAel\.'lUrnSthe continued safety 

o(cummtGRASsu!.>sUmcelI,3lId 

(3) FDA's approach roregu,latlng 

engineel'lld naflooWerials in GRAS suh-ltancahelpsenBUlO!thesaiety 

ofthefoodsuppiy. GAO ~e ... o:d 

FDA data on GRAS sub$tan<'ell' and 

/ntetvleweda nmgeof 

Sbkeholdel'S,antOngothffthlngs.. 

Wffli'ri·'·I:i49·j"j"'P,I .• GAO recommends thatFDA bke 

3teps to ootter ensure the saletyQt 

GRASsubstances,lncludlng 

devt:lopmgastnte(Ytol'l!QllirelUlY 

compallythatcondurts "GRAS 

def.EomtinatiOll to provide FDA wj!J\ 

bask information iIbollt it FDA 

~neraUyagt'ei!d.whlleraising 

concerns about certain aspectS of 

~t:al oldie recommendatiOO1 

"',_GAO-ll).2,",/)f~"I'ecmpon __ 

'ot<ll(ml IroIo:rTnstlon,COIltac:tllsa ShamMlIl 

{2(2)!i12·3$4101~am~51~gao.\JOI'. 

Page 19 

Q44·",au 

FOOD SAFETY 

FDA Should Sirengthen II. Oversight of Food Ingredients Determined to Be Generally RecognJzed a. Safe (GRAS) 

What GAO Found 

FDA's oversight process does !lot help erl'nlre the safety o!all!lew GRAS 

determinations. FDA only revle~ those GRAS determinations that companies 

"ubmit to the agency's voluntary notification program-the agency genetaUy 

does not have information about other GRAS determinations companies have 

made because companl('S are not required to infonn FDA of them. 

Furthennon:!. FDA h$ not taken ('ertain steps UNlt could help en.,ure the 

safety of GRAS detenninatiorL'l, particularly those about which the agency has 

not Oeen notified. FDA has not £SsUed guidance to companies on how to 

document Iheir GRAS detenninatiol1.'1 or monitored companies to ensure that 

Uley have conducted GR..\S determinatiONl appropriately. Lastly. FDA has yet 

to issue a final regulaticn for its 1997 proposed rule that sets l(lrth the 

framework and criteria for the vohmtaq noti1\cation program, potentially 

detractlJlg I'rom the program's credibility. 

FDAi5 not~maticall,y ensuring the continuedsaIety ofcturent GRAS 

subsra.nces. While, accontirlg to FDA regulatiOM, the GRASstatus ora 

substance must ~ te<:onmdered as new scientific information emetges. tile 

agency hasnot 9)'5tematkally reconsidered GRAS substances since the 1980s. 

FDA officials said they keep up with new developments 1n the sdenti.l'k 

literature and, on a case-by-case bllllis, inIormati<)n brought to the agency's 

attention conld prompt them to reconsider the safety ofa GRAS substance. 

However, rnA !las largely nol re:rponded to con~ms about GRASsubstances, 

soch 11$ salt and the tIaM fat!; in partially hydrogenated vegetable oib, that 

individuals and consumer groups have .raised through J I dti1:e-n petitions 

submttted to the agency between 2004 and 2008. In fact, FDA has decided on 

tlle validity of these COfl(:l'l'U9 in only 1 of 11 cases. In addition, FDA does not 

know to what extent, Ot"~n whether, companies track evolving 5(':ientiJk 

intormatkln about their GRAS substances. 

fDA's approach to regubUng JlMotet:hno!ogy allows ertgirl~red 

nanomaterlab to entertM rood supply as GRAS substances Without FDA'" 

knowledge. While somt> tlSe!J of Mgineet@d nanomateliab have the potential 

to help eJ\S\ltl!!OQd safety, uncertainties remain about hoW 10 determine thcir 

safety in rood After revie-wing U!e IlI1certainties associated with the safety of 

engineered nanomarerials, FDA has decided that it does not nee<! additional 

authority to rt'gUIaI.e products containinll such materials. Rather, FDA 

encourages, hut does not 1'e!{1lin!, companies considering using engine-ere<i 

na:wmaterials in food to consult with the 3gel\(:y regarding whether such 

substance'J might be GRAS. Because GRAS notification is voluntary and 

companies are not required to identify nanomatenaIs in their GRAS 

substances, FDA tuu no way of lmowin81.he full elUent to which (,l1guleered 

nanomateri:als have ent.enld the U.s. food supply as part 01 GRASsubstance!l. 

In contnst to FDA'!! approach, aU rood ingredients that incorporate 

engineered lUillOmaterials mll!it ~ submitted to re8UlaLo~ in Canadaalld the 

European Union l:H:!fore they can be marketed. 

_________ UnbctStM .. GcJwmmMII~OfI'I($ 

GAO-ItJ.699T 
60 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 66 76573A.047

Appendix IV: GAO-08-1 047 (Fresh Produce) 

(361191) 

Why GAO DldThIa Study 

Inreeenty~bothdome9t.lcand 

imported produce ha~ been linked 

tot\'!portedrnrtbresksotr~ 

illness. Comaminat1Ol1 l.n produee 

lsotpartteular"eonCtlmbecause 

produceisol'\;enCOllSUll'lt'df3w. 

~ food and Dl-u4I:A.:bninimatIon 

(FDA)halprimaty~b~ 

fotensurinllthe safetyolboth 

domestk: and imported fn!9h 

produce. GAO was <lllked to 

e:xamlne{l)the~FDAbas 

,pe:nton!reshproduc:$saIetyand 

/w",]thasaUocatedtbO!:ll! 

~(2:)thee~ne.Mot 

FDA',actioMtocovel'!l&elresh 

produce sak\:f, and (3) tl\e enent 

to wfllch FDA's planned actions to 

enhance~ produce oveiS/Iht 

addraaoldentiOedclW!enges.FM 

thl" 11Iv\eW, GAO:lU\aJyled FDA 1Ij)endlng dats and estimaf.es and 

FDA acuvities data, reviewed FDA 

pIaN, and lnterYlewed. rnA offtc/.rd$ando~ 

MOOI#61.,·.;; ... ';;,19,1 •• 

GAOreeontmeflds, amongotht'l' 

tllin8J,thattheC~<1t 

FDA update itaguidaneeongood 

agrk:u!tunsl~andits 

regulatlons on cummt good 

manu1'acturlngpracticefo;w(O(Jd. 

and seek explicit authority rrorn. the COfIgrMIItoadoptpn:M!ntive 

controls (f¥ hlgh-rbk foods and 

authority roc enhanced ac<:eSIi to 

""""" 

FDA~withmOlrtofGA(Y' 

lli!o::ommendadons but be!i~ that 

Ithadsoughtauthorltytromthe 

Congma FDA -should contmwr to take steps to obtain u-e authorlt1e!lIOtha1it(:llnconduct 

it3QVt!mgiltrnpoMibllittes. 

ro"_IIMru.pl'OlflA~a..1I<'CIPI; 

at>d~.cIIdI(lQGAO-<Ja-1047. 

FO!rro;nW!lrl'MIIon,~WuSha!Me:n 

(202).512-3Mlot~".,... 

Page 20 

FOOD SAFETY 

Improvements Needed In FDA Oversight of Fresh Produce 

What GAO Found 

While FDA Itai!I considered fresh produce safety a priority (or many years. 

resource constraints and other work-including cotmterterrortsm efforts and 

unplanned evenlS such as rOO<!bome illne59 outbrealc5-flave caused FDA to 

delay key produci!' safety actMties. FDA has no font'\al progrnm devote1i 

exclusively to fresh produQl and has not consistently and reliably trac:ked il3 

fresh prodUCt: !lpending. Based on FDA estimates. FDA spent at least $20 

million and 130 staff yean on fnsll produce in fiso::al year 2{)(}7---or about3 

percent o(il3 food 6afety dollars and .. pelUnt orits food safety stafryeacs.ln 

addition, FDA had lew staff dedicated solely tofresb produce safety. 

MOlfl)ver, FDA acknowledged that it has not yet ~n able to condu('t certain 

Cresb produce work crucial to undemanding the incidence or contamination 

otproduce by pathogens such as E. coli 0157:"7 or Salm.oneUo:, becaw!e it 

has lacked the 1l!'SOW.'Ce5 to eitheT rund its eIttll.mu.rni ~arch gnmt program 

or perfonn some critical resean:h IntemaUy. FinaUy, FDA dela,yed irJsuing final 

fresh-cut prodw::e guidance at least 6 y~ because It had toshift. staff to 

counwterrorism and outbreak. inYeltigat,ion work. 

FDA ha5 provided limited oveBight of ~c and imported fte9h produce. 

ForelQUtlple, while FDA h9s isstred. guidance Cor indusU'y on recommended 

practices for reducing the risk of contamination during the processing ot 

Cresn..cut produce, it has not issued regulations requiring firms to take action 

til prevent contamination, even though some indu1A:ry groups would like it to 

do so. FDA's int(!tvention eftomllave also been limited. Specifically. 

domeatie 1'n!9h produ<;e fum5 Wf!~ Inspected infn:quentiy. Furthermore, FDA 

examined 1elJ9 than 1 percent of the 7.8 million J'rem produce iin(!!l; tmported 

from fiscal yean2002 through 2007. ~nal.Iy, FDA /wIimprovetisome 

elementlf of i!.l5 emergency Te:'JPon5e by, for example, (!3rtnering with 

Calitomia on outbreak mve.mgatiorw.. How~r', it (ac~ challenges in tncing 

an outbreak invofving lh:!:sh produce back to il.s IIOtuee be<:awJe produee Is 

highly perishable and may no longer be available for testing. Also. wnen 

product 15 available, it may be unlabeled or miXed in packages cont.ainitlg 

productsfrommultiple90urees. 

FDA ha<J propost"d changes through Its Food Protretion Pfan that couJd 

.significantly enhance its fTe:sb produce ovet$ight. However, the agency iutill 

in the p1an.ning stages Cor several enhancements and has not provided specific 

information on ~gies and re~:IIUces, malting it dilrtcult to asstlSS the 

likelihood oflltlCOO:llJ. To help prevent contam!nadon, FDA plans to update it" 

ellisting guidance on good ~!turaI practic~ and regulalioM on CUlTll'nt 

good manuf':acturing pt'aC'tice rOl: food. and has identified a n~ for explicit 

aut!\ority to Issue prewntlw !W'ety regulal;1ons tor IUglHisk foods and 

enharu::edacceM to records. To enhance intervention efforts, i''DA plans to 

use more rigorous risk-bued criteria to target domestic firm inspections and 

IS testing a new import screening 30ttwarn tooL To unprove response elIorts, 

FDA is examining best practkt!!t tor tnl.cing contaminated (~to thl1ir 

source. 

_________ U!'lftNStl.tM~.t,c~I!ltrOfl'le. 

GAO-I0-699T 
61 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 67 76573A.048

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62 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 68 76573A.049

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<i Please Print on Recycled Paper 
63 

Mr. STUPAK. Thank you. 

Ms. Nudelman, your opening. 

TESTIMONY OF JODI NUDELMAN 

Ms. NUDELMAN. Good afternoon, Chairman Stupak, Ranking 

Member Burgess, and other members of the subcommittee. I am 

Jodi Nudelman, regional inspector general in New York for the 

U.S. Department of Health and Human Services Office of Inspector 

General. I appreciate the opportunity to appear before you today to 

discuss our most recent review of FDA’s food inspections program. 

FDA’s inspections are an important tool for ensuring food safety. 

Recent outbreaks, however, such as the salmonella outbreak 

caused by peanuts in 2009, have raised questions about FDA’s inspection process and its ability to protect the Nation’s food supply. 

Our most recent review focused on FDA’s inspections of domestic 

food facilities. In brief, our review found that more than half of food 

facilities went 5 or more years without an inspection. We also 

found that the number of FDA inspections is going down, even as 

the number of food facilities is going up. In 2004, FDA inspected 

over 17,000 facilities. In 2008, this number dropped to fewer than 

15,000. The number of high-risk facilities inspected also declined 

during this time. If FDA does not routinely inspect food facilities, 

it cannot be sure that these facilities are complying with the law 

and that the food they handle is safe. 

Our review also found that FDA’s inspectors are identifying 

fewer violations in food facilities. During an inspection, an inspector may find violations of FDA’s regulations or laws. Based on the 

nature of the violations, he or she may assign the facility a classification. In the most severe cases, the inspector will assign the facility an OAI classification, which means ‘‘official action is indicated.’’ Between 2004 and 2008, the number of facilities that received OAI classifications dropped from about 600 to less than 300. 

Most commonly, facilities received OAI classifications for unsafe 

practices and unsanitary conditions in the facility. These classifications resulted from violations such as food not being adequately refrigerated or evidence of rodent infestation. We also found that 

nearly three-quarters of the facilities that received OAI classifications had a history of violations. Even more concerning, half of 

these facilities had been cited for the exact same violation in a 

prior inspection. 

Further, our report found that FDA did not always take swift 

and effective action to remedy the violations. When a facility receives an OAI, FDA should consider taking some type of regulatory 

action. In the year that we studied, FDA took regulatory action 

against 46 percent of the facilities that received OAIs. For the remaining, FDA either lowered the classification or took no regulatory action. 

Moreover, for a third of the facilities with OAIs, FDA did not 

take additional steps to ensure that the violations were corrected. 

This means that FDA did not reinspect these facilities in a timely 

manner or review any other evidence to determine whether the violations were corrected. 

Based on these findings, we made six recommendations to FDA. 

We recommended that FDA increase the frequency of its inspecVerDate Mar 15 2010 03:39 Jan 19, 2013 Jkt 076573 PO 00000 Frm 00069 Fmt 6633 Sfmt 6602 E:\HR\OC\A573.XXX A573

pwalker on DSK7TPTVN1PROD with 
64 

tions, especially its high-risk inspections; provide additional guidance about when to lower OAIs; take appropriate action against facilities with OAIs; ensure that violations are corrected; seek the authority to access facilities’ records during an inspection; and, finally, consider seeking the authority to impose civil penalties 

through administrative proceedings. 

In conclusion, our report identified significant weaknesses in 

FDA’s inspections program. We found that many food facilities go 

without routine inspections. We also found that, when FDA finds 

violations, it does not always take swift and effective action to ensure that the violations are remedied. Taken together, our findings 

demonstrate that more needs to be done to protect public health 

and to ensure that FDA has the necessary tools to keep food safe. 

This concludes my testimony, and I welcome your questions. 

[The prepared statement of Ms. Nudelman follows:] 


pwalker on DSK7TPTVN1PROD with 
65 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 71 76573A.050

Testimony of: 

Jodi Nudelman 

Regional Inspector General for Evaluation and Inspections 

Office of Inspector General, U.S. Department of Health & Human Services 

Good afternoon, Chairman Stupak, Ranking Member Burgess, and other distinguished Members of 

the Subcommittee. r am Jodi Nudelman, Regional Inspector General for Evaluation and Inspections 

of the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG). I 

appreciate the opportunity to appear before you to discuss our oversight work as well as the vital role 

that the Food and Drug Administration (FDA) plays in protecting the Nation's food supply. 

Recent high-profile outbreaks offoodborne illness have underscored the importance of food facility 

inspections. My testimony today will focus on my office's recent review of FDA's inspection 

program.! In short, our report identifies significant weaknesses in FDA's inspections of domestic 

food facilities. We found that many food facilities went 5 or more years without an FDA inspection. 

We also found that there was a large decline in the number offood facility inspections conducted by 

FDA over a 5-year period, as well as a decline in the number of violations identified by FDA 

inspectors. Further, when violations were identified, FDA did not routinely take swift and effective 

action to ensure that these violations were remedied. 

Our reccnt report is a part of a larger body of OIG work that demonstrates that more needs to be done 

to ensure the safety of the Nation's food supply. In a report on food traceability, we found that only 

5 of 40 selected products could be traced through each stage of the food supply chain.' In addition, 

more than halfofthe facilities that handled these food products failed to meet FDA recordkeeping 

requirements. In another report. we found that 5 percent of selected facilities failed to register their 

facilities with FDA as required. Of those facilities that did register. almost half failed to provide 

accurate information in FDA's registry.3 Finally, we completed a report that found that FDA did not 

always follow its procedures when overseeing certain pet food recalls and noted that FDA docs not 

have the statutory authority to mandate recalls." 

OIG'S MISSION IS TO PROTECT HHS PROGRAMS AND BENEFICIARIES 

OIG is an independent, nonpartisan agency committed to protecting the integrity of the more than 

300 programs administered by HHS as well as the health and welfare of the people served by them. 

OIG fights fraud, waste, and abuse through a nationwide network of investigations, audits, and 

evaluations, as weI! as enforcement and compliance activities. 

OIG's work results in recoveries of misspent or stolen funds and in recommendations for program 

savings and improvements to program efficiency and effectiveness. In FY 2009, OIG investigations 

1 OIG, FDA Inspections o{[)omcstie Pood Pacilitics, OET-02-0S-00080, Apn12010. 

:! OIG, Traceabilit.y jn the Food SIlPP~V Cham, OEI-02'O(HI0210, l\'1arch 2008. 

:~ The Public Health Security and BlOterrol'ism PreparcdncSB and Response Act of 2002 reqlllres certain food facilities to 

register with FDA. The purpose of registrattOn IS to provldc FDA \vith rehahle informatIOn that. enables FDA to qUickly locate 

facIlities during outbreaks offoodborne dlness. See GIG, FDA's Food [<lief/fly Rc!!istl:J', OEI-02'08-000GO, December 2009. 

4 OIG, Review of the Pood lwd Dpllg Administration 8 Afonitorin{[o{ Pet Food fleCidls. "\-Ol'07-0150~, 200!). ",,' -,'" 

and Commerce, Subcommittee on 
66 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 72 76573A.051

resulted in $4 billion in settlements and court-ordered fines, penalties, and restitution. OIG audits 

resulted in almost $500 million in expected recoveries. OIG also produced equally important but les, 

quantifiable gains in deterrence and prevention of fraud, waste, and abuse and in improved program 

operations. Additionally, OIG has raised awareness of critical issues among policymakers. 

Government agencies, and other relevant stakeholders. Moving forward, OIG is committed to 

building on our successes and continuing to protect the integrity of Government programs and their 

beneficiaries. 

FOOD FACILITY INSPECTIONS ARE AN IMPORTANT TOOL TO ENSURE FOOD 

SAFETY 

Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming 

contaminated foods and beverages.s FDA is responsible for safeguarding the Nation's food supply 

by ensuring that food is free of disease-causing organisms, chemicals, or other harmful substances.6 

Recent outbreaks, such as the salmonella outbreak caused by insanitary conditions at a peanutprocessing plant in 2009-as well as others that resulted in large recalls of spinach, peppers, and 

alfalfa sprouts-have raised questions about FDA's inspections process and its ability to protect the 

Nation's food supply. 

FDA inspects food facilities to ensure food safety. During an FDA inspection, an inspector may 

identify potential violations of the Food, Drug, and Cosmetic Act or other applicable laws and 

regulations. Based on the outcome of the inspection, FDA assigns the facility one of three 

classifications: official action indicated (OAI), voluntary action indicated, or no action indicated. 

According to FDA guidance, when inspectors uncover violations that are significant enough to 

warrant OAI classification, FDA should consider taking some type of regulatory action. This 

regulatory action generally consists of either an advisory action or an enforcement action. Advisory 

actions usually allow an opportunity for the facility to voluntarily correct the violations found during 

the inspection, whereas enforcement actions are usually initiated in court and the facility is 

compelled to correct the violations found during the inspection. 

Once an FDA inspection finds violations at a facility, FDA uses several methods of dctermining 

whethcr a facility has subsequently corrected the violations. FDA may review evidence of corrective 

actions provided by a food facility or FDA may reinspect a facility to verify that corrections were 

made. 

OIG ASSESSED THE FHEQUENCY AND HESULTS OF FDA'S FOOD FACILITY 

INSPECTIONS 

Our study assessed the extent to which FDA conducted inspections and identified violations in 

domestic food tacilities.' It also assessed the extent to which FDA took regulatory action against 

food facilities with violations and ensured that these violations were corrected. 

5 Paul S, ~lead ct aI., "Food"Relaterl Illness ami Death In the United States," Emerging infectious Diseases, vol. 5, 1999, 

pp_ 607-625, b,Ymillble,QI!h!!<?"J!.-LDlll!1L~ww.e_dfgov/n~idod~~lQ.LVoll}nQ!)lmeQ_Q.Jnm. Accessed on December 14,2009 

6 FDA is responsible for ensuring the safety of almost all food products sold in the United Stfltes, with the exception of meat. 

poultry, and some egg products, which arc regulated by the U.S. Department of Agriculture. 

l1'hlS study mcludes inspect.ions of domestic food facllitlCs conducted by FDA or by StRtes under contract with FDA. ,.~ .,c; ," ",' ... ' eo" 

2 House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations: Hearing 

May 6, 2010. 
67 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 73 76573A.052

We based our study on three sources of data: (1) FDA's data on food facility inspections, (2) FDA's 

documentation of facility violations and followup activities. and (3) structured interviews with FDA 

staff. 

To determine the extent to which FDA conducts inspections, we analyzed FDA's data on all 

domestic food facility inspections for fiscal years (FY) 2004 through 2008. To determine the extent 

to which FDA took action against food facilities with violations and ensured that [hose violations 

were corrected, we requested from FDA all documentation related to OAI classifications received by 

facilities in FY 2007. We chose FY 2007 because it was the most recent timeframe that would also 

allow FDA sufficient time to initiate any actions and to complete any activities designed to ensure 

that violations were corrected. 

MOST FOOD FACILITIES WENT UNINSPECTED FOR AT LEAST 5 YEARS 

Our study found that 56 percent of food facilities that were subject to FDA inspection went 5 or more 

years without an FDA inspection. If FDA does not routinely inspect food facilities, it is unable to 

ensure that these facilities are complying with applicable laws and regulations and that the food 

handled by these facilities is safe. Except in a few instances, there are currently no specific 

guidelines that govern the tI'equency with which inspections should occur. 

Our study also found that the number of food facility inspections has declined, even as the number of 

food facilities has increased. In FY 2004, FDA inspected more than 17,000 facilities; in FY 2008, 

this number dropped to fewer than 15,000. During the same period, the number of food facilities 

subject to FDA inspection increased from about 59,000 to almost 68,000 facilities. We also 

identified a decline in the number of high-risk facilities inspected by FDA.' 

FDA officials attributed the decline in inspections primarily to a significant decrease in staffing 

levels that resulted from funding cuts. These officials noted that between 2003 and 2008, FDA lost 

almost a quarter oCthe stalTthat performs food facility inspections. They also noted that many of 

those losses came from the ranks of FDA's most experienced employees. 

THE FREQUENCY OF VIOLATIONS IDENTIFrED BY FDA INSPECTIONS DECLINED, 

AND MOST FACILITIES WITH VIOLATIONS WERE REPEAT OFFENDERS 

Facilities receive OAI classifications when inspectors determine that the violations found are 

significant enough to potentially warrant regulatory action. Facilities most commonly received OAl 

classifications for unsafe food manufacturing and handling practices and insanitary conditions in the 

facilities, such as improper handling of food or evidence of rodent infestations. 

From FY 2004 to FY 2008, the percentage of inspected facilities that received OAI classifications 

dropped from nearly 4 percent to less than 2 percent. Further, over this 5-year period, the number of 

facilities with OAI classifications declined from 614 facilities to 283 facilities. 

8 Each year, FDA deslgnates certain facilities as high risk. ThIS de;;ignation helps FDA determine whICh facilities should be 

gn.'cn a higher priority for IORpection Generally, these facihtJeR handle types of food that have II greater potential to cause 

harm. 

3 House Committee on 

May 6,2010. 
68 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 74 76573A.053

Our study also found that nearly three-quarters of the facilities that received OAI classifications in 

FY 2008 had a history of violations. Even more worrisome, halfofthe facilities that received OAI 

classifications had been cited for exactly the same violations in prior inspections. In one notable 

example. FDA found that a facility had the same unsafe manufacturing practices and insanitary 

conditions as it did during the previous four inspections. After each inspection, the facility promised 

to make corrections; however, each subsequent inspection revealed that nothing had changed. 

We also found that a small number of facilities refused to grant FDA officials access to records 

during an inspection. These records included descriptions of sanitation practices within each facility, 

lists of customers that received the facility's products, and descriptions of consumer complaints. 

FDA docs not currently have the statutory authority to require food facilities to provide access to 

these records." 

FDA DID NOT TAKE REGULATORY ACTION AGAINST MANY FACIL TIES WITH 

VIOLATIONS 

According to FDA guidance, when a facility receives an OAr classification, FDA should consider 

taking some type of regulatory action. This regulatory action generally consists of either advisory 

action or enforcement action. In FY 2007, FDA took advisory actions against 44 percent of the 446 

facilities that initially received an OAr classification, whereas FDA initiated enforcement actions 

against 2 percent of thesc facilitiesIO 

FDA lowered the classifications of29 percent of the facilities that initially received OAI 

classifications. The most common rcason for lowering a classification was that other FDA officials 

did not concur with the inspector's initial classification. The second most common reason for 

lowering a classification was that the facility either took or promised to take corrective actions. 

Although FDA guidelines allow inspection classifications to be lowered, FDA district offices 

appeared to be inconsistent when lowering classifications. For example, some district offices did not 

lower their OAI classifications after a facility promised to take corrective action, whereas other 

district offices did this more commonly. 

For 25 percent of facilities initially receiving OAI classifications, FDA neither took any regulatory 

action against the facilities nor lowered the classifications. In just over half of these cases, FDA 

officials noted that they did not take regulatory action because of their interpretation of FDA's 

program guidance. For example, FDA guidelines suggest that multiple warning letters should not be 

issued for the same violations. Several officials reported that they did not issue a warning letter 

because FDA had previously issued a warning letter to the facility. 

FDA OFTEN DID NOT TAKE SWIFT AND EFFECTIVE ACTION TO ENSURE THAT 

VIOLATIONS WERE REMEDIED 

FDA often failed to follow up with facilities to ensure that violations were corrected. In FY 2007, 

280 facilities received OAI classifications that were not lowered by FDA. FDA did not reinspect 36 

9 FDA has access to certam records held by infant formula facihtles as well as ccrtam records needed to trace an article of food 

through the food supply cham_ The limited Clrcumstancps under whtch FDA can acce!'lS these records arc described m 

21 U.S.U §§ 374 and :{50. 

10 The advisory actIons taken by FDA consisted ofwammg letters, untitled letters, and regulatory meetmgs. The 

enforcemont actlOns ta ken by FDA consisted of seizures and injunctions. 

4 ''''i·louse Committee on Energy and Commerce. Subcommittee on Oversight and [n;;s·;ig~ti~-;;~:·"YEaring 

May 6, 2010. 
69 


pwalker on DSK7TPTVN1PROD with Insert graphic folio 75 76573A.054

percent of these facilities within a year of the inspection or review evidence to ensure that the 

violations were corrected. 

For the remaining facilities, FDA took additional steps to ensure that the violations had been 

corrected. Specifically, FDA reinspected 35 percent of the facilities within a year of the initial 

inspection. For an additional 30 percent of facilities. FDA reported that it reviewed some type of 

evidence from the facilities demonstrating that they had corrected the violations." Examples of this 

evidence included photographs documenting corrections made in the facility, revised food labels 

documenting changes made to correct labeling violations, and a description of how employees were 

counseled. 

OIG RECOMMENDS SEVERAL ACTIONS TO STRENGTHEN FDA'S DOMESTIC 

INSPECTIONS PROGRAM 

Based on these findings, we made six recommendations to FDA to improve its domestic inspections 

program. Specifically, we recommended that FDA: 

increase the frequency of food facility inspections, with particular emphasis on high-risk 

facilities; 

provide additional guidance about when it is appropriate to lower OAT classifications; 

take appropriate actions against facilities with OAI classifications, particularly those that 

have a history of violations; 

ensure that violations are corrected for all facilities that receive OAI classifications; 

seek statutory authority to allow FDA access to facilities' records during the inspection 

process; and 

consider seeking statutory authority to impose civil penalties through administrative 

proceedings. 

IN CONCLUSION, MORE NEEDS TO BE DONE TO PROTECT THE SAFETY OF THE 

NA TION'S FOOD SUPPLY 

Our report identified significant weaknesses in FDA's inspections program. If FDA does not 

routinely inspect food facilities, it is unable to ensure that these facilities are complying with 

applicable laws and regulations and that the food handled by these facilities is safe. In addition, FDA 

must take swift and effective action to ensure that all violations are remedied. Taken together, the 

findings of this report demonstrate that more needs to be done to protect public health and to ensure 

that FDA has the necessary tools to prevent outbreaks of food borne illness. 

OlG recognizes the importance of ensuring the safety of the food supply and will continue our work 

in this area. We are currently conducting a review that assesses FDA's oversight of inspections 

conducted by State inspectors under contract. In addition, we are conducting an audit of selected 
70 


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food recalls to detennine whether FDA's oversight was adequate to ensure that the recalls were 

complete, accurate, and timely, 

This concludes my testimony. I welcome your questions. 

6 I-louse Committee on Energy and Commerce, Subcommirtec on Oversight and lnvestigations: Hearing 

May 6, 2010. 
71 

Mr. STUPAK. Thank you. 

And thank you to all the witnesses for your testimony. 

And let me just apologize. We got tied up on the floor. I thought 

we would be back by 3:15. It was about a half-hour later. You 

never know what happens when you get to the floor. 

We will now move to questions. 

Mr. Taylor, let me ask you this. The FDA announced a lettuce 

recall today. Freshway Foods is doing a voluntary recall of shredded romaine lettuce with a use on date by May 12th—or use on or 

before May 12th. I guess three people have been hospitalized. 

In the trace-back, do we have any idea of where that romaine is 

originating from? 

Mr. TAYLOR. Our understanding of the investigation so far is it 

came from a production site in Arizona, in Yuma, Arizona, where 

this company had its growing operations. We don’t know the cause 

of contamination, but we do know that there was product contaminated, people got sick. And so this recall is highly appropriate to 

protect the public health. 

Mr. STUPAK. Is the lettuce strictly grown in Arizona, or is it 

mixed with lettuce from Mexico, as we have seen in the past? 

Mr. TAYLOR. Well, this is romaine that is grown just in Arizona. 

And it is sold to institutions in a bulk sort of form, is the general 

way in which this product is distributed. 

Mr. STUPAK. If I remember correctly, when we were out in California, you were there with us, and we were doing some of the 

farming there. And I thought Arizona and California had a very 

good trace-back method. You could almost tell from what field it 

came from. Would you care to comment on this in the matter of 

this case? 

Mr. TAYLOR. Well, in this case, once we had the company identified, there was not a problem getting back to the source of production. 

Mr. STUPAK. OK. So the production field produced right there, 

and you don’t know if it is in machinery or whether it was the 

growing site. 

Mr. TAYLOR. We don’t know—yes, we are investigating, we are 

back at the farm investigating the cause, so that investigation goes 

on. But, as you know, there can be multiple vectors, avenues for 

getting this kind of contamination into an open field where product 

is growing. 

Mr. STUPAK. Right. It was for romaine that was used by the May 

12th. Today is May 6th. How long has this investigation been going 

on? 

Mr. TAYLOR. The first cases go back to—the first onset of illness 

goes back to April 6th. But it has been only in the last week or 

10 days that we became aware of this. There is that lag factor between people first becoming ill and it getting reported. 

Mr. STUPAK. Right. 

Mr. TAYLOR. And we found yesterday a positive sample of lettuce, 

which really confirmed the epidemiological hypothesis that this 

product was responsible for the problem. So there was actually a 

very swift recall response once the evidence fell into place. 

Mr. STUPAK. And I take it Freshway Foods has been cooperative, 

no problems there? 


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Mr. TAYLOR. They have worked closely and responded very quickly when the evidence came into place. 

Mr. STUPAK. OK. 

Ms. Nudelman, let me ask you this. I am looking at page 10 of 

your report. That is where you start with Table 1, food facilities inspected by the FDA, fiscal year 2004 through 2008. And I think 

you testified the average of the inspections were about 24 percent 

of all the places inspected. Correct? 

Ms. NUDELMAN. Yes. 

Mr. STUPAK. Now, the one that struck me was, in 2004 you had 

59,305 facilities should be inspected; by 2008, it has grown to 

67,819. If my math is correct, that is about 8,514 new facilities in 

less than 5 years. 

How is the FDA going to keep up with more and more facilities 

without the resources? 

Ms. NUDELMAN. I think that is a good question. I mean, clearly 

we document the number of facilities has grown and, at the same 

time, the number of inspections has declined. 

I think the other important factor in this is the number of highrisk inspections that are completed. And that is one way to target 

resources and target—— 

Mr. STUPAK. Right. Well, if we jump to the next table, that is 

Table 2, which is the high-risk facilities inspected by the FDA and, 

again, through the same years, 2004 to 2008. You have had, again, 

more high-risk facilities come online, about 565, if my math is correct here. The number of inspections has actually dropped from 77 

percent to 63 percent. 

Any correlation during that period of time from 2004 to 2008, 

how many inspectors did the FDA have? Did the number of inspectors go down? 

Ms. NUDELMAN. That is correct. And this is one of the things 

that FDA talked about in terms of the reason why there was a decline in the number of high-risk inspections as well as the number 

of overall inspections. 

Mr. STUPAK. Let me go to your next chart on page 12, again, 

number of inspections per facility between 2004 and 2008. I take 

it facilities inspected more than three times, there is 21 percent of 

them, were probably the greater or high-risk foods. 

Ms. NUDELMAN. I am not positive about that. That makes sense 

to me, but I am not—I can look at that in a little bit more detail 

for you. 

Mr. STUPAK. All right. 

Let me go to the bottom of page 14. In your report, you were 

talking about the FDA OAI classifications—refused to grant FDA 

officials access to their records. Most of the facilities had a history 

of violations. Then you say the FDA does not have statutory authority to require food facilities to provide access to these records. 

Do you know if the FDA ever received those records in these four 

or five cases? 

Ms. NUDELMAN. In the reports that we looked at, that was for 

2008, and it just documented clearly the types of records that they 

did not receive. I don’t know. And maybe FDA has a better sense 

of that. 

Mr. STUPAK. Yes, I was going to ask Mr. Taylor. 


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Any comment on that? Do you know if they ever received those 

records? 

Mr. TAYLOR. We got what we felt was a satisfactory resolution. 

Dr. Solomon can walk you through the details of each one. It varied 

from case to case. But, in some cases, we went ahead and got injunctions to solve the problem or took other forms of enforcement 

action. And if you would like, we can put—— 

Mr. STUPAK. Sure. Just quickly, if you could just tell us what 

would happen on those. 

Mr. SOLOMON. In one of those cases, we actually used the authority under the Bioterrorism Act, 414, to meet that threshold to have 

to request those records. Obviously, that delayed us. 

In two of the other cases, we conducted an injunction in order to 

try and get those records and requesting others for—— 

Mr. STUPAK. Injunction would stop them from doing what, shipping their product? 

Mr. SOLOMON. We were able to stop them from shipping product, 

and, at the same time, we used that consent decree that was signed 

to go to the suppliers there and get the information that we needed 

to control the product. 

Mr. STUPAK. OK. So you went to the supplier to find out what 

the facility was doing? 

Mr. SOLOMON. Correct. 

Mr. STUPAK. OK. 

Mr. SOLOMON. So these were longer processes that took us to try 

and get the records that were needed. 

Mr. STUPAK. Sure. OK. 

My time is up. Mr. Burgess for questions? 

Mr. BURGESS. Just staying with that concept for a minute, Mr. 

Taylor and Mr. Solomon, on the food safety bill that we passed out 

of this committee that is now awaiting activity over in the Senate, 

there is a provision for emergency recall, which I think you referenced, Mr. Solomon, as part of the bioterrorism defense. But, 

still, it is a voluntary recall under the bill that we passed. 

Is that your understanding, as well? 

Mr. SOLOMON. We don’t currently have mandatory recall authority, which is part of the Food Safety Enhancement Act. 

Mr. BURGESS. And after the passage of this legislation, is that a 

deficiency that you feel will be corrected? Or will you still be relying on the emergency provisions of the Bioterrorism Act to have 

that emergency provision? 

Mr. SOLOMON. We could use all the tools available, and we would 

use that mandatory recall authority if that was necessary in order 

to effectuate getting product removed from the market. 

Mr. TAYLOR. If I may add, the bill, 2749, would also give us routine records access, so the company would be obligated to provide 

the records we need to conduct an investigation and to find and 

discover the problems and solve the problems. 

Mr. BURGESS. Mr. Taylor, congratulations on your new post—— 

Mr. TAYLOR. Thank you, sir. 

Mr. BURGESS [continuing]. I think, I hope, for you. 

How many people currently work in your office? 

Mr. TAYLOR. Well, in my immediate Office of Foods, it is a very 

small staff of about 15 people. But we really work within the overVerDate Mar 15 2010 03:39 Jan 19, 2013 Jkt 076573 PO 00000 Frm 00079 Fmt 6633 Sfmt 6602 E:\HR\OC\A573.XXX A573

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all foods program. There is the Center for Food Safety and Applied 

Nutrition, the Center for Veterinary Medicine, and then the large 

field force. So, you know, there are upwards of 5,000 people in the 

foods program. 

But this new office that the commissioner created is a small leadership office, essentially. 

Mr. BURGESS. OK. Do you plan on expanding it? 

Mr. TAYLOR. The immediate office will grow slightly, but the last 

thing we want to do is to try to manage the program from the Office of Foods. We have great management teams and people 

throughout the foods program and these organizations, and our job 

is to lead and to unify and elevate their work within the FDA. 

Mr. BURGESS. So, you just referenced the Center for Veterinary 

Medicine. Those directors report to you, as well? 

Mr. TAYLOR. Yes, sir. The director of the Center for Veterinary 

Medicine reports to me, as does the director of the Center for Food 

Safety and Applied Nutrition. 

Mr. BURGESS. At this point, are you considering merging the 

Center for Food Safety as well as the Center for Veterinary Medicine? 

Mr. TAYLOR. We have no plans to merge the organizations. We 

are looking at how we manage this program in a unified way and 

how we can be sure that we are really able to empower the people 

in these organizations to accomplish the things they are setting out 

to accomplish. And so we are looking at how we manage the program, but we have no plan for mergers at this point. 

Mr. BURGESS. Let me just ask you a couple of questions about 

PREDICT since that has come up in your testimony as well as the 

testimony of the GAO. It holds promise, correct? 

Mr. TAYLOR. Yes, sir. 

Mr. BURGESS. But there were problems. 

Mr. TAYLOR. Yes. 

Mr. BURGESS. And those problems were related to the status of 

the IT systems that are surrounding it? 

Mr. TAYLOR. Yes, sir. Really—and I am not the IT expert on the 

case, but it is really a function of the aging IT infrastructure, the 

servers, the basic equipment that supports the IT system. 

And so what happened, in lay terms, is a combination of things. 

You put this whole new application onto the system, which put 

extra demand on the system. And it was happening at about the 

time that we have grown our field workforce. We have been able, 

with resources Congress has provided over the last couple of years, 

to hire additional inspectors and other people in our field force. 

So that combination of extra demands on an aging IT infrastructure resulted in slowdowns and some, you know, servers going 

down. And the IT people realized that that aging infrastructure 

could not support the new system. 

But, again, with resources Congress has provided, we are making 

the investments to upgrade that infrastructure. So, you know, that 

upgrade and the imperative to test that carefully and be sure that 

when we do implement—you know, that is pushing back implementation. But we hope to roll out PREDICT nationwide by the end of 

the year. That is our goal. 


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Mr. BURGESS. You anticipated my question. But I was going to 

ask you, you have developed a strategic plan for dealing with the 

deficiencies in the IT architecture? 

Mr. TAYLOR. Yes, sir. We have the—you know, upgrades are 

being made; it is being tested. You know, we will test the PREDICT system before we make it operational. But the IT folks are 

confident that we will have the infrastructure to support this and, 

you know, make it serve the function that we know it can, which 

will really be much better targeting of imports. 

Mr. BURGESS. So when we have this hearing a year from now, 

you will be able to report to me—— 

Mr. TAYLOR. I will be here, yes—— 

Mr. BURGESS [continuing]. Satisfactorily that it has been up and 

running for 6 months and it is targeted and in the right place? 

Mr. TAYLOR. That is our absolute aspiration and goal. We are 

working hard to achieve it. And we welcome coming back and giving that answer. 

Mr. BURGESS. You can understand the frustration of people 

who—you know, we are requiring every physician’s office across the 

country to make great investments in information technology, and 

our own FDA, which is our premiere Federal agency that handles 

25 cents out of every Federal dollar, at least domestically, has been 

unable to meet its own challenge. 

Clearly, we have to get our own house in order before we can be 

too critical of other people who have been slow in that regard, as 

well. 

Mr. TAYLOR. I understand. 

Mr. BURGESS. I am going to yield back to the chairwoman. 

Mrs. CHRISTENSEN [presiding]. Thank you, Mr. Burgess. 

The chair is now really honored to recognize our chairman emeritus, Mr. Dingell, for questions. 

Mr. DINGELL. Thank you, Madam Chairman. I commend you for 

the way you are presiding, and I thank you for being recognized. 

I want to begin by commending Chairman Stupak and the committee for this hearing. And I want to observe that this committee 

has completed a rather remarkable piece of legislation with regard 

to food safety that rests comfortably in the arms of the United 

States Senate. As my old daddy used to say, that is the place 

where good legislation goes to die. 

Regrettably, the points made by the witness on behalf of the 

GAO are very much on point. Her observation of the two statutory 

methods that need to be added to the arsenal of FDA are included 

in that legislation. 

I know this is going to sound a little hostile to the panel, but I 

want to begin by commending—and I want you to understand, 

there is nothing hostile in these questions. But I want to lay the 

framework of understanding how the events about which we are 

surrounded affect what it is we are doing. 

And I will start by observing that FDA, in 2008, inspected 153 

foreign food facilities out of 189,000 such facilities registered with 

FDA. That is, of course, only a small fraction of the, in fact, number of worldwide sources of foods imported to the United States. 

But we were able, in each of those years, according to GAO, to inVerDate Mar 15 2010 03:39 Jan 19, 2013 Jkt 076573 PO 00000 Frm 00081 Fmt 6633 Sfmt 6602 E:\HR\OC\A573.XXX A573

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vestigate only a very small number of the massive numbers of exporters into the United States. 

I noted, with regard to China, FDA conducted 46 inspections to 

China. China is one of the biggest exporters of food to the United 

States. I observe that that is a country which sends us melamine 

in milk products, mushrooms, vegetables, fish, shellfish, and other 

food products that are contaminated, dirty, filthy, or adulterated. 

And, frankly, again, the legislation to which we address ourselves sits over there in the Senate. That is a remarkable piece of 

legislation which came out of this committee unanimously with the 

full support of every single Member. And the leadership of this subcommittee made it possible for that legislation to move because of 

the way Mr. Stupak and the members of the committee, including 

my colleagues on the minority side, worked very hard to see to it 

that this legislation had not only a proper flooring and support but 

also a full justification. 

Now, having said these things, I would like to make a quick observation and then a question. 

Since 2007, FDA has had two major outbreaks linked to peanut 

butter, involving hundreds of illnesses and nine deaths. That is out 

of about the 5,000 deaths that exist in this country. 

And now I would like to address the types of enforcement action 

that have been taken against the companies. I would note that the 

GAO asserts that additional authority to routinely inspect records, 

detain food, subject violators to civil penalties, subpoena witnesses 

to help stepped-up enforcement efforts would be significantly helpful. 

Am I correct in that, to my witnesses down there, particularly 

you, Commissioner, and you, ma’am, from the GAO? 

Mr. TAYLOR. Yes, sir. Those new authorities are crucial to our 

doing our job. 

Mr. DINGELL. Now, I note FDA’s budget anticipates hiring 129 

new food and safety inspectors based on revenue from the registration and reinspection fees in H.R. 2749. 

What will happen, if you please, to its plans to hire these 129 

new inspectors if these fees are not included in the bill that the 

President signs as they are in the budget? 

Mr. TAYLOR. We won’t be able to hire those inspectors. And, you 

know, we need more inspections to ensure the safety of food. 

Mr. DINGELL. That means that the ongoing record of dismal ability to investigate or to inspect food processors will continue 

unabated. 

Mr. TAYLOR. Yes, sir. 

Mr. DINGELL. Now, I note that the Peanut Corporation of America recall, while it was still ongoing, one of the companies that received the PCA product, Westco Fruit and Nut Company, refused 

FDA access to important safety records and refused to conduct a 

voluntary recall, and FDA seized the product of the company. 

Now, I note that we should address—in that instance, Food and 

Drug would be able, had the legislation been passed, to use the 

mandatory recall authority to remove products that are already on 

the market. Is that not so? 

Mr. TAYLOR. Yes, sir, that is correct. 


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Mr. DINGELL. Now, how would such mandatory recall authority 

result in a different outcome in the Westco case? 

Mr. TAYLOR. Well, we could have directed that firm to recall that 

product, to stop distribution, withdraw the product from the market. We wouldn’t have to have been in a lengthy discussion and 

then have to go to court and get a judicial intervention. We could 

have acted swiftly with those—— 

Mr. DINGELL. In other words, all of this sawing of the air would 

have to go on while people were dying of bad peanut butter. 

Mr. TAYLOR. Again, if we are delayed in removing product from 

the market, people are at risk. 

Mr. DINGELL. Now, following the outbreak in the recall first 

linked to tomatoes and later to jalapeno and serrano peppers, the 

inspector general identified weaknesses in the current one-up/onedown traceability system, including bad record-keeping, lack of access to records, and firms that didn’t know about the requirements. 

Has FDA’s experience in other outbreaks confirmed flaws in the 

one-up/one-down traceability? 

Mr. TAYLOR. Yes, sir. I mean, that requires a lot of shoe leather 

by FDA. It is an old-fashioned paper system, essentially, when we 

have electronic alternatives, systems that the industry itself is developing, that can get us this information much more quickly. 

Mr. DINGELL. Now, how important is trace-back in containing 

food-borne illness outbreaks? 

Mr. TAYLOR. Trace-back is crucial. Once CDC identifies the food 

vehicle, we then need to be able to go back to the source of production so we can get to the root of the problem and contain it. So it 

is really crucial to public health, as well as to protecting the industry, to contain a problem so that the industry, its own business, 

won’t be disrupted any more than need be. 

Mr. DINGELL. You can protect honest men and women in the industry from unfair competition by scoundrels and rascals, but you 

would also protect them against unsafe materials that could enter 

into the products that they distribute. Isn’t that right? 

Mr. TAYLOR. Yes, sir. That is exactly it. 

Mr. DINGELL. Now, in your report—this is to Ms. Shames. In 

your report, you state CBP’s computer system does not notify FDA 

when imported food shipments arrive at U.S. ports. It is extremely 

important that these two agencies coordinate when it comes to imported food. Do you agree with that? 

Ms. SHAMES. We agree. We have been able to update that information, and CBP has told us that now it does give FDA the time 

of arrival. And this should help FDA in terms of coordinating its 

inspections. 

Mr. DINGELL. What additional steps need to be taken by the administration to fully address this concern? 

Ms. SHAMES. We feel that CBP should continue to work towards 

this effort to share time-of-arrival information with USDA. That 

part of our recommendation has not yet been implemented. 

Mr. DINGELL. Thank you. 

Madam Chairman, you have been most kind to me with regard 

to the time. I yield back the balance. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 


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I now recognize myself for 5 minutes of questions. And I want 

to ask a question about information sharing, as well. 

Ms. Shames, I would like to ask you about GAO’s finding that 

FDA does not always share product distribution information with 

State regulators during a recall. If food needs to be removed, FDA 

may not give State regulators important information like which 

grocery stores and warehouses received the recalled product. 

FDA’s inadequate coordination with States means that States 

must duplicate FDA’s efforts and track down the same information. 

You found that public health—and I guess this is a quote—may be 

at risk during the time it takes for the States to independently 

track distribution information when a product is found to be contaminated. 

So my question, Ms. Shames: FDA’s limited provision of information to States during an outbreak seems illogical, so what is the 

agency’s rationale for withholding that information? 

Ms. SHAMES. FDA says that this information is commercially 

confidential. And while we recognize that, we still recognize the 

public need that the State agencies are often the ones that are actually going into the grocery stores and removing the contaminated 

product off of the shelf. What we recommended to FDA and what 

FDA agreed to is that they would explore ways to try to get comparable information to the State agencies. 

I should note that USDA, the Food Safety and Inspection Service, does give product name information to the States as a way of 

trying to expedite any recall. 

Mrs. CHRISTENSEN. OK. 

So, Mr. Taylor, so you have agreed, and you have the authority 

to share that information with the States? 

Mr. TAYLOR. We are able to share this information with State officers who are commissioned by FDA. And to some extent around 

the country we have actually commissioned State officials to function as FDA officials, so we are able to do it to that extent. But 

we do have legal constraints under the laws that govern disclosure 

of information. 

This is a strong feature of the legislation, H.R. 2749, that this 

committee has passed, that the House has passed, because it would 

explicitly authorize us to share information with State officials, 

with other organizations, when necessary to protect public health, 

and still protecting the confidences of companies but getting the information in the hands of people who need it to protect public 

health. And we enthusiastically embrace that. We need that clear 

authority from Congress. 

Mrs. CHRISTENSEN. OK. Thank you. You answered the rest of my 

question. 

My next question is on monetary bonds and civil penalties. I am 

concerned that FDA may not have sufficient authority to keep an 

importer from violating food safety requirements. Under our current system, the importing company maintains control over their 

food shipments but is not allowed to release them until FDA approves. Importers post a monetary bond with Customs and Border 

Protection to guarantee the product will meet all U.S. Requirements, including those of FDA. 


pwalker on DSK7TPTVN1PROD with 
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At least, that is how the system is supposed to work. But the 

GAO investigation found that FDA and Customs and Border Protection officials do not believe that the bonding system stops import 

firms from releasing their goods prior to FDA approval. GAO found 

that many brokers and importers expect that they will occasionally 

have to forfeit the monetary bond as part of the cost of doing business. 

So, again, my question to you, Ms. Shames, is: Why is the current system of monetary bonds not a sufficient deterrent? 

Ms. SHAMES. What we are seeking is for FDA to be able to assess 

the civil penalties, to make it more of a deterrent for unscrupulous 

importers who try to do that. 

Mrs. CHRISTENSEN. Is the amount of the bond adequate as a deterrent, or does it need to—— 

Ms. SHAMES. FDA and CBP officials told us that they thought 

that the amount of the bond really was insufficient. 

And this is something that we reported in an earlier report back 

in 1998. So, well over a decade ago, we were hearing this information from those agencies. 

Mrs. CHRISTENSEN. And your testimony stated that GAO recommends that the FDA commissioner seek authority from Congress to assess civil penalties. Can you elaborate? Why does FDA 

need authority to assess the civil penalties? 

Ms. SHAMES. Now it cannot do that; it relies on CBP for any enforcement actions. And giving FDA this authority, again, we feel, 

would be a deterrent for any unscrupulous importers. 

Mrs. CHRISTENSEN. So, Mr. Taylor, if FDA could impose civil 

monetary penalties for violations of food safety requirements, 

would that assist FDA in its mission? 

Mr. TAYLOR. That would be a big help, to create more accountability for importers. 

There is another very important feature of the legislation, 

though, that would require importers to register with us and to 

meet requirements for their own practices in order to stay registered, to stay in business as importers. So we would have also the 

authority to de-register an importer. 

So, again, it is critical that we enhance the accountability of importers to play by the rules, essentially. 

Mrs. CHRISTENSEN. Is there authority needed to increase the 

amount of the bond—well, that would be CBP. 

Mr. TAYLOR. Right. 

Mrs. CHRISTENSEN. Yes. Thank you. 

OK, I am out of time. So are we going to have a second—oh, you 

are back. 

I will recognize Mr. Burgess, Dr. Burgess, for a second round of 

questioning. 

Mr. BURGESS. Thank you. 

Mr. Taylor, approximately 13 million shipments of food arrive in 

the U.S. Every year from foreign producers. And, of course, the 

number is growing, as we have seen from all the graphs. 

There are numerous examples of foods that have been problematic. We have heard about the melamine in the milk and the problems with gluten and some of our pet food contamination of a few 

years ago. 


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You have opened some stations overseas, the FDA has opened 

some stations overseas. In addition to that—and the first question 

is, have we opened enough? Have we done enough in that regard? 

And what other measures are we employing to increase or enforce lax safety standards in other countries? 

Mr. TAYLOR. Yes. You know, I think it is going to take a combination of tools and efforts to ensure the safety of imports. 

Those foreign offices are—they are not inspection posts, but they 

are critical posts for gathering intelligence about what is happening in other countries, to explain our requirements to foreign 

governments and to foreign firms. 

But that is just one small piece of the toolkit. We do need to do 

more inspections overseas, but we also need to hold the importer 

accountable and see that they are policing their own supply chain 

and being able to provide real assurances to us, documented assurances, that they are producing products overseas or sourcing their 

product from facilities that meet our standards. 

So it is going to take a combination of things. But it is all about 

building more accountability into the supply chain, all the way 

back to the point of production. 

Mr. BURGESS. And it would seem intuitive that the importer 

would want that accountability in the supply chain, because, after 

all, if their products are felt to be unsafe when they get over here, 

their market share is going to suffer. 

But is the FDA working with the importers directly in a collaborative fashion, educational fashion, to try to get more accountability on that end? 

Mr. TAYLOR. We do work with the importer community. We have 

issued guidance to the importer community on good importer practices that we think they should observe to meet that responsibility, 

to offer food only that meets our standards. 

You know, some importers feel the accountability. They are part 

of a supply chain. The major processor in this country might be the 

importer, in some cases. But, in other cases, importers don’t have 

a stake in what happens to the food after it passes from them, and 

so they lack accountability. 

And so there is a real gap in the system, you know, if we don’t 

have systematic accountability on importers as a critical part of the 

safety assurance system. 

Mr. BURGESS. So what can you do to impose that degree of accountability if it may not exist naturally as part of the marketplace? 

Mr. TAYLOR. We need the passage of H.R. 2749. That is one of 

the most critical elements of the legislation, to define that accountability, to give us the authority to set the rules that the importers 

need to play by in order to provide an adequate assurance that the 

food that they are offering is meeting our standards; again, backed 

up by our own ability to go inspect, backed up by what foreign governments are doing, backed up by a host of other checks. 

But that importer accountability is really a linchpin of the system. And it is lacking now as a really enforceable matter. It is 

something we urge on the industry, but there is no legal requirement for the importer to really take that responsibility. They only 

run the risk that we will send the food back. Or, you know, they 


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may get it into the country under a bond, and, as a cost of doing 

business, you know, some of them, unscrupulous, will make a decision to let the product go. 

So there is a lack of accountability in that part of the system 

that H.R. 2749 would directly address. 

Mr. BURGESS. I have always felt that it really is necessary to 

have some sort of a stop button that you guys can push in a hurry 

if you need to, if we find that we have something coming in that 

we really shouldn’t. 

Ms. Nudelman, let me just ask you a question. And I apologize 

if Chairman Stupak has already covered this. But, in the report, 

it found in fiscal year 2007 the FDA took no regulatory action for 

25 percent of facilities who received the OAI classification. 

Why would the FDA classify a facility as ‘‘official action indicated’’ rather than one of the lesser classifications and then take 

no action? What would be a possible—that seems counterintuitive 

to me. What would be a possible rationale for doing that? 

Ms. NUDELMAN. Well, in some cases, if the facility agreed to take 

action or promised to take action, then they did not issue—they did 

not take any further regulatory action. That was the most common 

response that we heard. 

Mr. BURGESS. And then how is the follow-up for that overseen to 

ensure that, indeed, the voluntary action was taken and the problem was corrected? 

Ms. NUDELMAN. Well, that is one of the things we found. In 

about 36 percent of the facilities, FDA didn’t take any—didn’t reinspect to ensure that the correction was made or look at any other 

evidence. So there is not always the follow-up. 

Mr. BURGESS. So that is still inherently a weak spot that needs 

to be fixed. 

Ms. NUDELMAN. Correct. 

Mr. BURGESS. Thank you, Mr. Chairman. I will yield back. 

Mr. STUPAK [presiding]. Mr. Dingell, did you have a question or 

two on this second round here, please? 

Mr. DINGELL. Mr. Chairman, I will impose again briefly upon 

your patience. And I want to thank for your courtesy to me. And 

I also want to commend you for the series of hearings you have 

held on these matters, because they have made it possible for us 

to move forward in a very significant fashion to protect people and 

to see that Food and Drug finally has the law and the resources 

it needs to do its business. 

Now, these questions are for Ms. Nudelman. There are 226,373 

foreign food facilities registered with FDA. When the inspector general looked at the domestic facilities registered in 2009, it found 48 

percent provide inaccurate information; 7 percent either fail to register or failed to cancel their registrations; and 5 percent created 

multiple registrations. 

Now, if domestic registrations are this prone to errors, in your 

opinion, how reliable is the list of foreign facility registrations? 

Ms. NUDELMAN. The numbers that you cite are right on, and it 

would make—I think it is even more challenging for foreign facilities to have accurate information in the registry. 

Mr. DINGELL. Now, what can be done to help FDA improve the 

accuracy of its registration lists? Obviously, more people; obviously, 


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more money; obviously, more inspections; obviously, a better computer system. 

Do they need, in addition to that, additional authority under law 

to do the things that need to be done, to induce better cooperation 

from the people who are supposed to register? What has to be done, 

in your expert opinion? 

Ms. NUDELMAN. I think there is a number of ways FDA can improve the accuracy and the completeness of the information in the 

registry. We make a recommendation to FDA to consider seeking 

the authority to have facilities register on a more routine basis. 

And that would allow the facilities to provide updated information 

about the foods they handle and about contact information. 

Mr. DINGELL. Thank you. 

Now, Mr. Taylor, do you have a comment you would like to 

make? 

Mr. TAYLOR. Well, I think that suggestion that Ms. Nudelman 

made is an excellent one. I think the requirement to have a unique 

identifier is important. And I think the requirement for the importer, as part of good importer practices, to be able to vouch for 

the accuracy of the information, identifying the foreign sources of 

supply, the foreign facilities from which they are sourcing products 

for import—all of those, I think, would really improve the reliability of the registration list. And those are all addressed in the 

Food Safety Enhancement Act. 

Mr. DINGELL. Now, Ms. Shames, you have talked about the ability to inspect. And, in your very excellent study, you talked about 

the need for FDA to be able to do a better job of getting the cooperation of Homeland Security and other government agencies. 

How could that best be done? Could that best be done by having 

a memorandum of agreement between the agencies, a memorandum of agreement required by congressional action, or by some 

other mechanism whereby we could see to it that these two very 

important agencies, or several very important agencies, talk to 

each other so that they are able to use the advantages that comes 

with having several different agencies enforcing different laws but 

able to work together to address the problems that concern us? 

Now, what is your comment, please? 

Ms. SHAMES. It will be a multifaceted solution to a very complicated problem, and I wish I could tell you that there will be a 

single step that could correct that. We found that at the working 

level that the relationships between FDA and CBP were oftentimes 

very cordial, that they were able to work around, for example, not 

getting the time of arrival information. 

Mr. DINGELL. Of course, that is a structural failure, is it not? 

Ms. SHAMES. Well, yes, in this case it was. 

Mr. DINGELL. And whose fault is that, the other agency or is that 

the importer or the food broker or who? 

Ms. SHAMES. Well, there are many players that are involved in 

the oversight of food safety. FDA is one, and, as you noted, CBP 

really is the first face for an importer. So one of the challenges that 

we identified is CBP’s own computer system, that that system—— 

Mr. DINGELL. And that’s probably hopelessly out of date, as is 

the Social Security computer system. 


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Ms. SHAMES. Well, there are hardware changes that would have 

to be made, for example, for getting a unique identifier. This is 

something that FDA feels it needs. We have certainly identified 

that it’s something that is very important, but CBP told us that it 

would be difficult for its current system to do it, and they really 

could not offer any sort of timeline of when that might be done. 

So it’s structural in terms of the many agencies that are involved, but it also gets to the resources in terms of, you know, the 

computer systems that it has in place as well as the people. 

Mr. DINGELL. Thank you. Mr. Chairman, again, thank you for 

your courtesy to me, and I want to remind everybody that you and 

this subcommittee have had tremendous leadership in this matter. 

I want to remind everybody that this committee, working unanimously, together in a bipartisan fashion, has set out legislation 

that would address the problems we now discuss today, which reside comfortably in the United States Senate. 

Thank you, Mr. Chairman. 

Mr. STUPAK. Well, hopefully the Senate will move that legislation, get it to conference, and we can go from there. 

Let me ask, Ms. Shames, about the unique identifier. How can 

one firm have 75 different identifiers? 

Ms. SHAMES. It can happen very inadvertently, when a company 

registers for an import shipment, it may identify itself one time as 

White, Incorporated. The second time the company might identify 

itself as White Company. So it is something that is done most of 

the time, very innocently, but it means that there needs to be some 

sort of scrubbing of the list to make sure that each company has 

a single—— 

Mr. STUPAK. So the company enters its information on a computer Web site so it is really the company that enters it, which 

would then give it a number—— 

Ms. SHAMES. That’s right. 

Mr. STUPAK [continuing]. Which could be unique on something as 

simple as an address, a different address. 

Ms. SHAMES. Yes. 

Mr. STUPAK. Does Customs and Border Patrol use unique identifiers? 

Ms. SHAMES. They do not, no. They also—— 

Mr. STUPAK. Shouldn’t they actually have access to it at the 

same time? Shouldn’t that company give it to Customs and Border? 

Ms. SHAMES. Ideally FDA and CBP and would have the same 

unique identifier. 

Mr. STUPAK. Ideally, but reality is they don’t, right? 

Ms. SHAMES. Right. 

Mr. STUPAK. If we would limit the number of ports that food 

could be imported into this country, would that help? 

Ms. SHAMES. Well, that is an approach that USDA takes. 

Mr. STUPAK. Right, on meat products. 

Ms. SHAMES. Well, that only USDA regulated imports come from 

food systems that have or are equivalent to ours, only through designated ports. USDA also goes and audits those countries to make 

sure that their systems are comparable or equivalent. 

Mr. STUPAK. Well, is that something we should look at? I was 

going back to your chart number one that you had in here, you 


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know, you said 80 percent of our seafood comes from foreign 

sources, I think she said 60 percent of our fruits and vegetables. 

And they can come into basically any airport or any trucking location on our border,correct? 

Ms. SHAMES. That’s true, yes. Stakeholders that we have spoken 

to said that it would be difficult for FDA to really replicate the 

same system that USDA has, because—— 

Mr. STUPAK. I am not saying replicate it, but shouldn’t you limit 

the ports of entry? I mean, how can you control anything if every 

airport and every truck crossing is basically a port of entry for food 

or seafood? 

Ms. SHAMES. Well, it’s an approach that the European Union has 

taken to limit the ports for its risk-based foods, so it is—there are 

precedents for it. 

Mr. STUPAK. Any comments on that, Mr. Taylor, on either unique 

identifiers or limit the number of ports? 

Mr. TAYLOR. Yes. Again, from a consistent—an ease of implementation by the regulatory agency, that’s certainly advantages to that. 

I think the challenge we face that is different from the USDA is 

that, you know, we are dealing with a much larger array of commodities coming from a much larger volume of countries, there’s a 

huge volume of trade. 

And so I think there would be, you know, big practical questions 

you would have to work through. I don’t think anyone wants to disrupt the trade in food, but we need to be sure it’s safe. And how 

do you do that? It’s a really important question. 

Mr. STUPAK. Let me ask you this then, Mr. Taylor, you mentioned the shipper’s bond. What is the usual amount of a bond? 

Does it depend on the product and the value? 

Mr. TAYLOR. Typically three times the value of the shipment. 

Mr. STUPAK. OK. You said many times the shipper will just forego the bond. 

Mr. TAYLOR. Again, our understanding is that some shippers, you 

know, who have a large volume of business are willing to just take 

that chance of letting a product go out into commerce, even though 

it’s still under bond, because, you know, in the whole course of 

their business they don’t get caught very often or they aren’t— 

there’s not a problem that requires that that product be brought 

back. And so, again, it’s the cost of doing business for some of these 

firms. 

Mr. STUPAK. Well, should we make it higher? 

Mr. TAYLOR. I think you could try a higher bond. I mean, I think 

the civil penalty approach is one part of it. I think the importer accountability and the fact that an importer could lose its registration under the Food Safety Enhancement Act would be perhaps 

even stronger tools, you know, to make them have really something 

really at stake for playing by the rules. That’s what we need to do. 

Mr. STUPAK. You know, Mr. Dingell pointed out, and I think we 

have all pointed out that, you know, it’s expensive to keep our food 

supply safe and the agency needs inspectors, and I think GAO report says, what, $16,000 per inspection at a food facility. And the 

IG said that, and I am quoting now, The decline in inspection is 

largely due to the significant decline in staffing level that resulted 

from cuts. 


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And in the legislation that we have pending in the Senate, the 

Food Safety Enhancement Act, we have an annual registration fee 

of $500. These fees would be devoted towards funding a variety of 

food safety activities. Any idea and what percentage would go towards inspectors? 

Mr. TAYLOR. Well, we would envision the fee revenue being used 

to a significant degree to meet the inspection mandates, or to at 

least contribute to meeting the inspection mandates in the legislation. But we also have to invest those resources in the tools for the 

inspectors and the scientific basis for what they are doing, so it 

would be a mix of activities. And you could also contribute to the 

import oversight. 

So we would distribute it across a mix of activities to meet the 

objectives of the statute. 

Mr. STUPAK. Well, under the Obama administration, did you not 

receive a substantial increase in money for food safety in the last 

year? 

Mr. TAYLOR. The 2010 budget is, yes, is an increase over 2009, 

and there’s an increase requested in 2011. 

Mr. STUPAK. Well, have you hired more inspectors? 

Mr. TAYLOR. Yes, sir, the last 2 or 3 years of funding has enabled 

our field force to add 6- or 700 inspectors, who are completing their 

training, and we are going to be able to increase our inspections 

because of that in the coming years. So there has been that step 

up, you know, through the increases we have gotten. It’s not sufficient to meet the inspection mandate in the legislation, but it’s a 

step in the right direction, which we appreciate. 

Mr. STUPAK. OK. Mr. Burgess, any questions? 

Mr. BURGESS. Yes. Just following up on that last line from Mr. 

Stupak about the budget, did you, did the FDA receive any money 

from the stimulus bill or the big health care bill that we just 

passed? 

Mr. TAYLOR. No—there was some money that went into HHS for 

management matters related to FDA like comparative effectiveness 

of pharmaceuticals, but there was not money that directly affects 

the food program. 

Mr. BURGESS. Did the Obama administration seek funding for 

the FDA in either one of these laws? 

Mr. TAYLOR. Well, again, the stimulus money was about immediate projects that could stimulate economic activity in the near 

term and so that we—— 

Mr. BURGESS. Mr. Taylor, we gave $10 billion to NIH. Are you 

any less deserving than they are? 

Mr. TAYLOR. We would never say—— 

Mr. BURGESS. $10 billion to NIH. Now I love the guys at NIH, 

but you are important too. 

Mr. TAYLOR. Yes, sir, we agree with you. 

Mr. BURGESS. Well, do you know why the administration didn’t 

ask for additional funding for the FDA in either of these laws? 

Mr. TAYLOR. I would have to get back to you on that. I don’t personally—I wasn’t involved in that. 

Mr. BURGESS. Well, and it’s all well and good, just like the 

Obama budget, and what great things are going to happen as a result of it, but we are not going to pass a budget on the floor of this 


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House I don’t think, unless Mr. Stupak knows something that I 

don’t know—— 

Mr. STUPAK. It wouldn’t be first time getting me wrong on legislation. 

Mr. BURGESS. And certainly, we are not going to do any appropriations bills before election day, so your level of funding till some 

omnibus in the lame duck session, so are you oK with that level 

of funding at this point? 

Mr. TAYLOR. Well, again, we are going to need additional resources to carry out the expectations of the Food Safety Enhancement Act. Again, that’s why the fee provision and that—the registration fee provision in that law, that bill is very important to us. 

We do need a stable, predictable and adequate level of resources 

to meet the mandates in the legislation. 

Mr. BURGESS. Well, and I couldn’t agree with you more and that 

a stable, predictable source of funds is not just true for you but 

true other agencies as well, but so far we seem to be doing things 

in fits and starts. And you, in fact, got left out of the fits and 

starts, unfortunately. 

Mr. Chairman, you have been very indulgent. It has been a long 

day. I am going to yield back the balance of my time. 

Mr. STUPAK. Thanks, Mr. Burgess. And as Mr. Dingell has pointed out, you know, the Food Safety Act went through this committee 

51–0, and we appreciate our colleagues on the Republican side of 

the aisle to help us provide a stable funding source for that FDA 

through that $500 per facility registration fee. That will provide 

the stable funding so we do have the resources to get to it. 

It’s not just resources it’s, information sharing. And hopefully we 

can do that whether it’s Customs and Border Patrol or we get the 

PREDICT program worked out a little more so the high risk foods 

we can identify. 

Well, thank you and thank you to all of our witnesses. Sorry 

about the delay there on the floor for a while. We appreciate you 

staying with us and being here today. 

That concludes all questioning. I want to thank all of our witnesses for coming today and thank you for your testimony. The 

rules of the committee provide that members have 10 days to submit additional questions for the record. That concludes our hearing. 

This meeting of the subcommittee is adjourned. 

[Whereupon, at 4:58 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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Opening Statement of the Honorable Joe Barton 

Subcommittee on Oversight and Investigations 

Hearing on 

"The Role and Performance of FDA in Ensuring Food Safety" 

May 6th, 2010 

I thank the Chairman and Ranking Member Mike Burgess for 

convening this hearing today. 

We understand the role the agency plays in protecting the Nation's 

food supply, and after more than a decade of bipartisan oversight 

and investigation, we also understand the FDA's history of 

problems. 

Today, our subcommittee will hear testimony about many of the 

inefficiencies found in FDA's food regulators and inspection 

protocols. But I would like to highlight my concerns about GAO's 

recent findings in a report written for me and the former ranking 

member, Mr. Walden. 

Our request to GAO stemmed from the Committee's work two 

years ago looking into FDA's ability to protect the public from 
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unsafe food and drugs. We were concerned that FDA's attempts to 

measure performance and progress had become an over-bearing 

and useless paper exercise. I regret to inform the subcommittee 

that we were right. 

Specifically, GAO found that the agency's performance measures 

are inadequate. Rather than focus on outcomes, FDA does little to 

assess how money spent actually improves safety and public 

health. 

Secondly, FDA cannot show how the employees they hire will be 

put to effective use in the critical area of IT, which is at the root of 

FDA's persistent past failures. 

Lastly, FDA does not track how employees use their time, so we 

cannot track whether the agency is actually putting the proper 

resources toward achieving FDA's public health and safety 

mission. 

The taxpayer deserves a transparent and accountable system =. 

Americans deserve to know whether their tax dollars are spent 

effectively by the FDA. 
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At the same time as I voice my concerns about the FDA, I believe 

the food safety legislation that passed the House in July oflast year 

provides the agency with many tools to ensure the safety of our 

food supply. 1 worked with the other Members of the Committee 

to create a prevention-based approach to fixing this food safety 

problem. 

One way the legislation does that is by requiring companies to 

create and properly execute food-safety plans. Experts continue to 

agree that if companies involved in recent outbreaks had foodsafety plans, the crises would not have happened. 

Mr. Chairman, I want to thank you for this hearing and your 

willingness to work with the Republicans on this issue. There is 

still work to be done, but I am hopeful that we are on a path to 

improved implementation. I look forward to hearing testimony 

and questioning from the Members and witnesses here today. 

I yield back the balance of my time. 
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