AGRICULTURE, RURAL DEVELOPMENT, FOOD 

AND DRUG ADMINISTRATION, AND RELATED 

AGENCIES APPROPRIATIONS FOR 2010 

HEARINGS 

BEFORE A 

SUBCOMMITTEE OF THE 

COMMITTEE ON APPROPRIATIONS 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND 

DRUG ADMINISTRATION, AND RELATED AGENCIES 

ROSA L. DELAURO, Connecticut, Chairwoman 

SAM FARR, California 

ALLEN BOYD, Florida 

SANFORD D. BISHOP, JR., Georgia 

LINCOLN DAVIS, Tennessee 

MARCY KAPTUR, Ohio 

MAURICE D. HINCHEY, New York 

JESSE L. JACKSON, JR., Illinois 

JACK KINGSTON, Georgia 

TOM LATHAM, Iowa 

JO ANN EMERSON, Missouri 

RODNEY ALEXANDER, Louisiana 

NOTE: Under Committee Rules, Mr. Obey, as Chairman of the Full Committee, and Mr. Lewis, as Ranking 

Minority Member of the Full Committee, are authorized to sit as Members of all Subcommittees. 

MARTHA FOLEY, LESLIE BARRACK, CLIFF ISENBERG, and MATT SMITH, 

Staff Assistants 

PART 4 

Page 

Food Safety Oversight: U.S. Department of Health and 

Human Services, Office of Inspector General .............. 1 

Food and Drug Administration ............................................ 65 

Protecting the Public Health in a Global Economy: 

Ensuring That Meat and Poultry Imports Meet U.S. 

Standards ............................................................................... 141 

Printed for the use of the Committee on Appropriations 


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PART 4—AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, 

AND RELATED AGENCIES APPROPRIATIONS FOR 2010 


jbell on DSKDVH8Z91PROD with HEARING
AGRICULTURE, RURAL DEVELOPMENT, FOOD 

AND DRUG ADMINISTRATION, AND RELATED 

AGENCIES APPROPRIATIONS FOR 2010 

HEARINGS 

BEFORE A 

SUBCOMMITTEE OF THE 

COMMITTEE ON APPROPRIATIONS 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND 

DRUG ADMINISTRATION, AND RELATED AGENCIES 

ROSA L. DELAURO, Connecticut, Chairwoman 

SAM FARR, California 

ALLEN BOYD, Florida 

SANFORD D. BISHOP, JR., Georgia 

LINCOLN DAVIS, Tennessee 

MARCY KAPTUR, Ohio 

MAURICE D. HINCHEY, New York 

JESSE L. JACKSON, JR., Illinois 

JACK KINGSTON, Georgia 

TOM LATHAM, Iowa 

JO ANN EMERSON, Missouri 

RODNEY ALEXANDER, Louisiana 

NOTE: Under Committee Rules, Mr. Obey, as Chairman of the Full Committee, and Mr. Lewis, as Ranking 

Minority Member of the Full Committee, are authorized to sit as Members of all Subcommittees. 

MARTHA FOLEY, LESLIE BARRACK, CLIFF ISENBERG, and MATT SMITH, 

Staff Assistants 

PART 4 

Page 

Food Safety Oversight: U.S. Department of Health and 

Human Services, Office of Inspector General .............. 1 

Food and Drug Administration ............................................ 65 

Protecting the Public Health in a Global Economy: 

Ensuring That Meat and Poultry Imports Meet U.S. 

Standards ............................................................................... 141 

Printed for the use of the Committee on Appropriations 

U.S. GOVERNMENT PRINTING OFFICE 

55–703 WASHINGTON : 2010 


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COMMITTEE ON APPROPRIATIONS 

DAVID R. OBEY, Wisconsin, Chairman 

NORMAN D. DICKS, Washington 

ALAN B. MOLLOHAN, West Virginia 

MARCY KAPTUR, Ohio 

PETER J. VISCLOSKY, Indiana 

NITA M. LOWEY, New York 

JOSE ́ E. SERRANO, New York 

ROSA L. DELAURO, Connecticut 

JAMES P. MORAN, Virginia 

JOHN W. OLVER, Massachusetts 

ED PASTOR, Arizona 

DAVID E. PRICE, North Carolina 

CHET EDWARDS, Texas 

PATRICK J. KENNEDY, Rhode Island 

MAURICE D. HINCHEY, New York 

LUCILLE ROYBAL-ALLARD, California 

SAM FARR, California 

JESSE L. JACKSON, JR., Illinois 

CAROLYN C. KILPATRICK, Michigan 

ALLEN BOYD, Florida 

CHAKA FATTAH, Pennsylvania 

STEVEN R. ROTHMAN, New Jersey 

SANFORD D. BISHOP, JR., Georgia 

MARION BERRY, Arkansas 

BARBARA LEE, California 

ADAM SCHIFF, California 

MICHAEL HONDA, California 

BETTY MCCOLLUM, Minnesota 

STEVE ISRAEL, New York 

TIM RYAN, Ohio 

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland 

BEN CHANDLER, Kentucky 

DEBBIE WASSERMAN SCHULTZ, Florida 

CIRO RODRIGUEZ, Texas 

LINCOLN DAVIS, Tennessee 

JOHN T. SALAZAR, Colorado 

——— ——— 

JERRY LEWIS, California 

C. W. BILL YOUNG, Florida 

HAROLD ROGERS, Kentucky 

FRANK R. WOLF, Virginia 

JACK KINGSTON, Georgia 

RODNEY P. FRELINGHUYSEN, New 

Jersey 

TODD TIAHRT, Kansas 

ZACH WAMP, Tennessee 

TOM LATHAM, Iowa 

ROBERT B. ADERHOLT, Alabama 

JO ANN EMERSON, Missouri 

KAY GRANGER, Texas 

MICHAEL K. SIMPSON, Idaho 

JOHN ABNEY CULBERSON, Texas 

MARK STEVEN KIRK, Illinois 

ANDER CRENSHAW, Florida 

DENNIS R. REHBERG, Montana 

JOHN R. CARTER, Texas 

RODNEY ALEXANDER, Louisiana 

KEN CALVERT, California 

JO BONNER, Alabama 

STEVEN C. LATOURETTE, Ohio 

TOM COLE, Oklahoma 

BEVERLY PHETO, Clerk and Staff Director 

(II)


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AGRICULTURE, RURAL DEVELOPMENT, FOOD 

AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR 

2010 

THURSDAY, MARCH 26, 2009. 

FOOD SAFETY OVERSIGHT: U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES OFFICE OF INSPECTOR GENERAL 

WITNESSES 

DANIEL R. LEVINSON, INSPECTOR GENERAL 

JODI NUDELMAN, REGIONAL INSPECTOR GENERAL, OFFICE OF EVALUATION AND INSPECTIONS, NEW YORK, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

THOMAS E. STENZEL, PRESIDENT AND CEO, UNITED FRESH PRODUCE 

ASSOCIATION 

CRAIG HENRY, SENIOR VICE PRESIDENT FOR SCIENCE AND REGULATORY AFFAIRS, GROCERY MANUFACTURERS ASSOCIATION 

OPENING STATEMENT, CHAIRWOMAN DELAURO

Ms. DELAURO. The committee is called to order. 

Good morning. And let me thank all of you and welcome you here 

this morning. And a special welcome to our witnesses: 

Daniel Levinson, the Inspector General for the Department of 

Health and Human Services; 

We have Tom Stenzel, President of United Fresh Produce Association, someone who is very familiar with many of us on the subcommittee—we thank you, Tom, it is good to see you back here; I 

am glad you got through the traffic; and 

Craig Henry, Senior Vice President for Science and Regulatory 

Affairs for the Grocery Manufacturers Association. 

Now, Jodi, you tell me your title here because you are at the 

table here. 

Ms. NUDELMAN. I am Regional Inspector General in New York. 

The CHAIRMAN. Okay. Lovely. Thank you so much for being here. 

I guess we are not sure yet as to when and where and how, but 

to the Inspector General, thank you, we don’t know when the last 

time was that you appeared before the committee, but we are delighted to have you here. 

Mr. LEVINSON. I think this is my first time. 

The CHAIRMAN. All right; let’s hear it for that. Thank you very, 

very much. 

I want to say thank you again to everyone for taking the time 

to share your insight and experience. And again, a special thanks 


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to Tom and Craig, it was short notice, but we are delighted you are 

here. 

My colleagues and I all believe that we have a responsibility on 

this subcommittee to confront issues of public health and public 

safety. And when families can no longer trust that the food they 

eat is safe, government has to respond. We need to be there. 

For many years we have fought to reform—and I will make this 

my own view—a dysfunctional Federal agency, an FDA that is unable to meet its most basic regulatory responsibilities. And our 

work continues as we strive to provide the resources and the tools 

in order to effect change. 

Today’s hearing focuses on a very important tool for combating 

food-borne illness outbreaks. That is traceability, traceability in the 

food supply chain, the ability to follow a food product’s path back 

from the store where it was purchased to the place at which the 

contamination occurred. It is critical to identifying both the source 

of a potentially dangerous outbreak and the location where contaminated products have been sold and may even be still available. 

We were reminded just how important traceability is during last 

year’s salmonella outbreak, originally linked to tomatoes. As we all 

know, the FDA later turned its attention away from tomatoes, ultimately determining that peppers from Mexico may have been the 

source of the outbreak, but not before the market for tomatoes 

shrank dramatically and tomato growers suffered. 

And so this outbreak raised some important questions. What if 

an effective traceability system had been in place? Would the FDA 

have been able to find peppers as the original source sooner in its 

investigation, minimize the impact on the tomato industry, prevent 

needless additional illnesses? 

We are going to attempt these questions, review the report on 

traceability released today by the Office of the Inspector General 

at the Department of Health and Human Services. The report assesses the traceability of selected food products. 

In its examination, the Inspector General’s Office was able to 

trace only 5 of the 40 products through each stage of the food supply chain. What is more, the Inspector General found 59 percent 

of food facilities failed to meet FDA’s requirement to maintain 

records on their sources, recipients or transporters. The tools were 

put in place by the 2002 bioterrorism law, yet neither the law nor 

the implementing regulations gave FDA authority to put a system 

in place ensuring companies comply with the requirements under 

the law. 

There are other gaps as well. The law exempted farms and restaurants from the recordkeeping requirement. And in moving from 

the draft rule to the final rule, the Office of Management and 

Budget exempted foreign facilities completely and significantly limited the kinds of companies required to maintain lot-specific information. 

Traceability today simply is not good enough; it is inconsistent, 

it is unreliable. I think these findings confirm what many in the 

Congress already believe, that we can do better, that we have a responsibility in the event of a food-borne illness outbreak to effectively find the source of contamination as quickly as possible and 

prevent further illness, and even death. 


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To be sure, the Inspector General study involved only 220 facilities. And I want to just say, I am pleased to have this report. I 

think it is a good beginning; I think it points us in the direction 

of what we have to try to do, but it involved only 220 facilities. 

OMB has estimated that more than 700,000 facilities are subject 

to the traceability requirements we are discussing today. And yet, 

while this study is not a valid statistical sample of the entire industry, it provides us with a glimpse into how these requirements 

are actually being carried out. 

In its report, the Inspector General recommends that the FDA 

seek additional authority, and in fact, the FDA has formally requested some authority related to traceability in its food protection 

plan. At the same time, traceability has considerable support in the 

Congress and will likely be included in food safety legislation that 

moves forward this year. 

But also, as we study the Inspector General’s findings, I think 

we also have an obligation to ask whether the FDA could have 

done a better job with the authority it had. When tomatoes were 

first suspected as the potential source of last year’s salmonella outbreak, I know some growers were frustrated by the Agency’s inability to act on what it knew. 

I think it is fair to say that the United Fresh Produce Association has been out front on the issue of traceability, and I hope Mr. 

Stenzel will speak to the issue. 

We also look forward to hearing Mr. Henry discuss the Grocery 

Manufacturers Association’s use on traceability. 

Mr. Stenzel, Mr. Henry, we value your perspective and your experience as the Congress works to craft legislation, that it does not 

interfere with the traceability technologies that are already working in the marketplace. I think your testimony will help the subcommittee determine where FDA can best leverage its resources to 

strengthen traceability systems. 

From farm to fork, our food system is vast, it is complicated, and 

we need to build an effective traceability system. And it is not easy 

to do. But with the public health at stake, I believe that it is essential, and I believe this subcommittee believes it is essential for us 

to do. 

So I thank all of our witnesses this morning for their participation. I look forward to the testimony. And let me ask our ranking 

member, Mr. Kingston, if he would like to make an opening statement. 

OPENING STATEMENT OF RANKING MEMBER KINGSTON

Mr. KINGSTON. Thank you, Madam Chair. I look forward to the 

hearing, and I look forward to hearing from these panelists. And 

particularly, it is good to see Mr. Levinson again; I hadn’t seen him 

in a while. I didn’t know he has already been here 4 years, so time 

does fly. 

But two things that I really want to focus on in terms of the 

traceability debate are, number one, what is the critical safety 

point in the processing of the food? For example, it might not matter so much where a chicken was raised as much as it is important 

where it was cooked. We may need to trace back to the very beginVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00003 Fmt 6633 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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ning, but maybe we don’t. And we should focus on where can you 

put the most effort and get the most benefit from. 

And then the second part of that is, what is the risk benefit? For 

example, there is going to be some food where it is easy to trace 

because we are already kind of doing it, but maybe there is no real 

benefit in it. Or there may be another question as to where is the 

risk and which foods are riskiest. 

I think we should actually cherry-pick certain food groups to say, 

these are the ones that are the most critical, they seem to have a 

relationship with food-borne illnesses more than this group. And 

those are the ones that, from a starting point, we should focus on, 

rather than try to embrace the whole world of consumption as an 

initial step. 

So those would be my comments. And I will yield back. Thank 

you. 

Ms. DELAURO. Thank you, Mr. Kingston. Let’s move to our testimony. 

And I will just let our witnesses know that your full statement 

will be in the record, so feel free to just outline and summarize 

your comments for the committee, and then we will move to questions and answers. 

Mr. Levinson. Thank you. 

OPENING STATEMENT, DANIEL LEVINSON

Mr. LEVINSON. Thank you, Madam Chair. I would like to just 

read a brief summary of my lengthier written testimony, which I 

would request be made a part of the record. 

Good morning, Madam Chair, and members of the subcommittee. 

I am Daniel Levinson, Inspector General for the U.S. Department 

of Health and Human Services. I am here today with Jodi 

Nudelman, our Regional Inspector General for the Office of Evaluation and Inspections in New York. 

Recent outbreaks of food-borne illness involving peanut butter, 

peppers and spinach have raised serious questions about FDA’s 

ability to protect the Nation’s food supply. The Office of Inspector 

General has identified FDA oversight of food, drugs, and medical 

devices as a top management challenge and has conducted several 

reviews of FDA’s oversight of food safety over the past decade. I appreciate the opportunity to appear before you today to discuss our 

most recent work on the traceability of the food supply. 

In short, we conducted a food traceability exercise and found that 

only 5 of the 40 products we purchased could be traced through 

each stage of the food supply chain back to the farm or border. 

Several factors limited our ability to trace the remaining products. These factors would also limit FDA’s ability to respond quickly and effectively to a food emergency. In addition, many food facilities did not comply with FDA’s records requirements, and existing 

records requirements are not sufficient to ensure traceability. 

These findings demonstrate that more needs to be done to protect 

public health and to ensure that FDA has the necessary resources 

and tools to respond to a food emergency. 

Each year, more than 300,000 Americans are hospitalized and 

5,000 die after consuming contaminated foods and beverages. In a 

food emergency, FDA is typically responsible for finding the source 


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of the contamination and removing unsafe food products from retail 

shelves. FDA’s ability to fulfill its duties largely depends upon 

whether it can follow a food product’s movement through each 

stage of the food supply chain, a process referred to as traceability. 

The food supply chain typically starts on farms and can involve 

manufacturers, processors, packers, distributors, transporters and 

retail stores before reaching the consumer. Beginning in 2005, FDA 

required these facilities, with several exceptions, most notably 

farms, to maintain records with contact information for all sources, 

recipients, and transporters. 

Additionally, some of these facilities, specifically processors, 

packers and manufacturers, must also record what is known as lotspecific information to the extent that it exists. Lot-specific information distinguishes one production batch from another, and can 

be a number or other identifier that is printed on the product. 

These records help FDA to trace a product through each stage of 

the food supply chain during a food emergency. 

Our review had two objectives. First, we assessed the traceability 

of 40 selected food products that we purchased from retail stores 

around the country. Second, we determined the extent to which 

food facilities maintained the required information about their 

sources, recipients and transporters. We found that only 5 of the 

40 products we purchased could be traced through each stage of the 

food supply chain. In these five cases, every facility that handled 

the product was able to link it to lot-specific information in their 

records. 

For 31 of the 40 products, we were only able to identify facilities 

that likely handled the products. Many of the facilities that handled these products could only estimate a range of deliveries that 

likely included the product. These estimates may have included 

more facilities than actually handled the product, or may not have 

included all of the facilities that handled the product. 

For the remaining four products, we could not even identify the 

facilities that likely handled them. In these cases, at least one facility in the food supply chain failed to provide any information about 

the potential source of the product. In a food emergency, there 

could be a serious health consequence if FDA cannot, at a minimum, identify the facilities that potentially handled a contaminated food product. 

We identified three factors that limited the traceability of food 

products. First, food facilities did not always maintain lot-specific 

information. A few processors did not maintain this information 

even though they were required to do so. In addition, many other 

types of facilities did not maintain lot-specific information. 

Second, several products did not have lot-specific information on 

the product or packaging, which is not currently required by the 

FDA. 

Third, a number of facilities mixed raw food products from a 

large number of farms, a process known as commingling. For example, a single bag of flour we purchased contained wheat from more 

than 100 farms. 

The second objective of our review was to assess facilities’ compliance with FDA’s requirements to maintain contact information 

about their sources, recipients and transporters. We found that 59 


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percent of the food facilities did not maintain this required contact 

information. In addition, a quarter of the food facilities reported 

that they were not aware of FDA’s requirements to maintain this 

contact information. Noncompliance with these requirements affects FDA’s ability to trace food products through the food supply 

chain. 

Based on these findings, we made six recommendations to the 

FDA: 

One, FDA should strengthen the existing records requirements 

regarding lot-specific information. Specifically, FDA should seek 

statutory authority, if necessary, to require processors, packers, 

and manufacturers to create lot-specific information and maintain 

it if it does not exist. FDA also should extend the requirements to 

include facilities that are currently not required to maintain this 

information. 

Two, FDA should consider seeking additional statutory authority 

to require food facilities to further strengthen food traceability. 

This could include a variety of approaches, such as requiring facilities to use information technologies to help facilitate recordkeeping. 

Three, FDA should work with the food industry to develop guidelines on traceability. 

Four, FDA should address issues related to mixing raw food 

products from a large number of farms. 

Five, FDA should seek statutory authority to request facilities’ 

records at any time. 

And finally, FDA should conduct education and outreach activities to inform the food industry about its record requirements. 

In conclusion, in the event of an outbreak of a food-borne illness, 

FDA needs to be able to quickly identify the source of a contamination and remove unsafe products from retail shelves. Our review 

demonstrates that more needs to be done to protect public health 

and to ensure that FDA has the necessary resources and tools to 

respond to a food emergency. 

We share your commitment to this issue, and we currently have 

work under way related to FDA’s inspections of food facilities and 

whether facilities register with the FDA. And we have ongoing 

work as well on FDA’s procedures for recalls. 

This concludes my oral testimony. I will welcome your questions. 

Ms. DELAURO. Thank you very much, Mr. Levinson. 

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Ms. DELAURO. Tom Stenzel. 

OPENING STATEMENT, TOM STENZEL

Mr. STENZEL. Thank you very much, Madam Chairwoman. 

Thank you for holding this hearing today on the important issue 

of traceability for the entire food industry. 

I think all of you on the committee know of our industry’s call 

for mandatory Federal oversight of produce safety standards, and 

I assure you today that we feel the same way about traceability. 

It is an important cornerstone of our food safety efforts. 

Let me mention three specific areas this morning: first, the general state of traceability today in the produce industry; secondly, 

major initiatives that we now have under way to build more 

streamlined whole-chain traceability; and finally, share some brief 

recommendations for the Congress and FDA moving forward. 

Traceability of fresh produce is a very complex and expensive undertaking, linking multiple partners in a sometimes long supply 

chain. Each company is responsible for maintaining the information required to comply with the Bioterrorism Act, mandating one 

step up and one step back. But just to give you a sense of the enormity of that effort, we estimate that six billion cases of fresh 

produce a year are shipped in the United States. 

I think it is best to look at produce traceability in three groups: 

individually packaged produce that often carries a UPC code, bulk 

produce in its original carton, and then bulk produce that may 

have been repacked or commingled with other lots for product quality. 

With prepackaged produce, such as fresh salads, a bag of fruit 

or cut vegetables in a package, UPC codes serve as the product 

identifier, linking back to specific codes identifying the product 

source. We are unaware of any instances in which public health investigators having a package in hand have been unable to quickly 

and efficiently reach the company that packaged the product. 

Bulk produce poses a different challenge in that the produce is 

often removed from the original carton for final display and consumer sale. For those products, recordkeeping by the retail establishment or the food service company that has dropped that product at a specific restaurant is required to begin linking an individual produce commodity back down the chain. 

Finally, bulk produce is sometimes repacked between the farm 

and final consumer destination. Because produce commodities are 

likely to be of different sizes, colors, shapes, and stages of ripeness, 

repackers play an important role in our industry in sorting the 

highest quality produce very close to its final consumer destination. 

Most frequently today, individual lot integrity is maintained during this sorting process, but there are times when different lots of 

produce must be mixed for product quality, and outgoing cases are 

still expected to carry information that is traceable to the incoming 

different produce lots that have gone into that single case. 

The industry is fully committed to one up, one down requirements of the Bioterrorism Act, and we have repeatedly urged FDA 

to enforce this law. I am particularly pleased and interested in 

reading the Inspector General’s report today, as this is precisely 

the type of analysis that we need conducted before an outbreak, 


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that can help us focus on the areas where individual operators 

need to improve in their own traceability systems. 

In a similar initiative last summer, investigators from the Energy and Commerce Committee, Oversight and Investigation Subcommittee, conducted several real-world trace-backs, tracing tomatoes from a restaurant that was picked randomly out of a phone 

book. They were amazed at the results. They were able to get back 

to the original farm source within a matter of hours. 

Next, let me talk about some of the exciting new initiatives that 

are under way in the produce industry to take traceability another 

step forward. More than a year ago, our association joined with industry partners to develop a common, industry-wide framework to 

standardize case coding for all produce sold in the United States. 

While today most companies have the ability to track one up, one 

down in their own systems, the adoption of a standardized coding 

system across our industry will connect each stage more quickly 

and efficiently. Every case of produce will be labeled with a global 

trade item number, called a GTIN, which identifies the originator 

of the case and the type of product inside. It will also carry a lot 

number specifically identifying the produce, including its packing 

or harvest date. Labels will carry a bar code with this information 

which each member of the supply chain will be able to scan so that 

the information can be stored and readily available. 

Adoption of these standards is now in motion; it is not just an 

idea. With commitments from retailers, wholesalers, and produce 

growers across the chain, we are promoting this initiative through 

a new Web site, producetraceability.org, numerous industry meetings; and, in fact, we are building a 10,000-square-foot produce 

traceability demonstration center at our association’s upcoming annual convention to help the industry begin to adopt these practices. 

One last item I would mention in the emerging technology area 

is what is called the GS–1 data bar, an electronically readable code 

small enough to even fit on a fruit or vegetable sticker. I brought 

several examples of those and include one in my testimony. 

You will begin to see in your store now on this little sticker that 

has the price look-up number—— 

Ms. DELAURO. Man, after my own heart with a green pepper. If 

you cook that with sausage, it is very good. 

Mr. STENZEL. Madam Chair, I will leave this for you after the 

hearing. 

These codes are going to be very helpful to us in the emerging 

technology area. 

Ms. DELAURO. All the information is on that little sticker? Can 

you pass that up? 

Mr. STENZEL. Sure. 

The information that is contained on these codes today includes 

the company or the packer who originates it. The codes are not actually big enough to include the lot number, so that is an important point for us in new technology development, but it is going to 

be a step forward in the ability to track exactly where that piece 

of produce came from. 

We are also early in the stage of adoption at the retail level. 

Most retailers cannot actually scan that data yet. They need a new 

generation of scanning technology at the checkout line. But I think 


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that does lead me to my final point and recommendations for the 

committee and Congress. 

One is to look at the ability of technology to help us in this effort. 

First, please look at the unique aspects of tracking bulk fresh 

produce. We are certainly going to be different from other sections 

in the food industry. We are likely to find that overly prescriptive 

mandates from the top down are not as likely to be as effective as 

efficiencies from the bottom up in the industry, the new technologies that we are talking about here. We believe that we are on 

the right course with the produce traceability initiative I have discussed, and we ask that Congress set the goal that we need to 

achieve, not mandate the process. 

Secondly, I would ask the committee to consider ways of assisting in meeting the cost of traceability requirements. While larger 

companies may adopt these technologies on their own, it is essential that cost burdens do not prevent all companies from adopting 

these protocols. 

Third, let me suggest that the FDA engage in more practical, 

hands-on traceability exercises just as the IG has done here. Our 

industry stands ready to cooperate with the committee, the FDA, 

the IG, and any others, in doing mock trace-back exercises on an 

ongoing basis. 

Fourth, I recommend that we urge FDA to enforce the current 

law before we completely call it a failure. If, in an outbreak situation, FDA finds companies not in compliance, then take action, 

take highly visible action. That is what signals the importance of 

proper behavior to those in any industry who might be inclined to 

cut corners. 

Finally, Madam Chair, I need to share a little frustration with 

you, as I am sure you anticipate. But the enhancements we are 

talking about today would not have prevented the anxiety of last 

summer’s salmonella outbreak. This past summer, we saw what 

could only be called a ‘‘wild goose chase’’ or, rather, a ‘‘wild tomato 

chase.’’ For weeks and weeks, officials blamed the slow search on 

the lack of traceability. 

We now know the problem was we were searching for the wrong 

product. In reality, FDA was able to trace tomatoes back to the 

farm, the only problem was those trace-backs kept pointing to different farms. FDA called that inconclusive, but we now know better. Trace-back was conclusive, and it showed that there was no 

common point where all of those tomatoes could have been contaminated. Trace-back worked, it just didn’t confirm the original 

hypothesis. 

Once jalapenos were identified as the real culprit, Minnesota 

health officials quickly traced the peppers back, from a small restaurant in Minneapolis to a food service distributor, to a tiny 

wholesaler in Texas, and a farm 500 miles south of the Mexican 

border. The Minnesota investigators were quoted as saying, ‘‘It 

took a few phone calls, and you can work it fairly quickly back to 

the grower.’’ 

Now, I know our industry is far from perfect in our ability to 

track product, and we want to understand the gaps; but that description more closely resembles the industry I know today. We are 

capable of tracking most produce one step up and one step back, 


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but just as importantly, we are committed to streamlining and expediting that process just as fast as we can. Thank you. 

Ms. DELAURO. Thank you very much, Mr. Stenzel. 

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Ms. DELAURO. Mr. Henry. 

OPENING STATEMENT, CRAIG HENRY

Mr. HENRY. Thank you, Madam Chairwoman, and the members 

of the subcommittee, for allowing me to testify today. 

My name is Craig Henry. I am the Senior Vice President and 

Chief Operating Officer for the Science and Regulatory Affairs Division of the Grocery Manufacturers Association. I have over 30 

years of experience in manufacturing operations and related food 

safety programs, which includes traceability. 

As stated earlier, Americans enjoy one of the safest food supplies 

in the world, but food and beverage companies recognize that steps 

must be taken to make our food supply even safer. Ensuring the 

safety of our products and maintaining the confidence of consumers 

is the single most important goal of the food and beverage industry 

today and going forward. 

Product safety is the foundation of consumer trust, and our industry devotes enormous resources to ensure that our products are 

safe. Our industry strongly supports efforts to continually improve 

the safety of America’s food supplies and urges the subcommittee 

to continue to make the prevention of contamination the foundation 

of our Nation’s food safety strategies. 

Recommendations that we have are as follows: 

One, increase FDA food-related spending. GMA, and the members that it represents, strongly supports proposals to increase 

FDA food-related spending to rebuild FDA scientific and regulatory 

capacity. 

We applaud the subcommittee for providing FDA with the critical resources in the 2009 fiscal year Omnibus Appropriations bill, 

and urge you to provide a comparable increase for food-related activities in the subsequent fiscal year of 2010. 

Regarding food safety plans, certainly GMA strongly supports 

proposals in House and Senate legislation requiring every food 

company manufacturing food for the U.S. market to conduct an 

evaluation of food safety risks that identifies potential sources of 

contamination, identifies appropriate food safety controls, and documents those controls in their food safety plan. 

We should require foreign supplier safety programs and build 

foreign capacity. GMA strongly supports proposals in both the 

House and Senate legislation to build the capacity of foreign governments to regulate food safety and to require every food importer 

to police their foreign suppliers. In particular, we support proposals 

to require that food importers document the food safety measures 

and controls being implemented by their foreign suppliers, and to 

require foreign importers to make a foreign supplier food safety 

plan available to FDA. 

On fruits and vegetables, again, we support proposals to give 

FDA the power to establish Federal safety standards for certain 

fruits and vegetables when science and risk demonstrate that 

standards are needed. FDA should be permitted to work with 

States and to tailor standards to meet local growing conditions and 

to ensure that those standards are met. 

On risk-based inspection, GMA strongly supports House and 

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cilities that pose the greatest risk of contamination that could result in food-borne illness or injury. To focus scarce resources, FDA 

should permit expedited entry for imports that pose no meaningful 

risk. 

On traceability, government and industry should work collaboratively to identify and address gaps in our current traceability 

system, including measures that will ensure that responsibility for 

traceability is shared throughout the supply chain, measures that 

will improve the interoperability of current and future traceability 

systems, and that are built upon and encourage industry innovation. In particular, GMA strongly supports the House and Senate 

proposals to develop and test promising new traceability systems 

through pilot programs in the produce sector. 

Lastly, on authorization of mandatory recalls, GMA strongly supports proposals in the House and Senate legislation to give FDA 

the authority to order a mandatory recall when a company producing FDA-regulated products has refused to conduct a voluntary 

recall and there is a significant risk to public health. Specifically, 

where the responsible party refuses to voluntarily recall a product 

for which there is a reasonable probability that the food will cause 

serious adverse health consequences or death, the Secretary of 

Health and Human Services should be permitted to order an FDAregulated company to recall immediately. 

GMA applauds your efforts to seek swift and lasting improvements to our food and safety system. We look forward to working 

with you to continually improve the safety of America’s food supplies. 

I would be pleased to entertain any questions. 

Ms. DELAURO. Thank you very much. 

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Ms. DELAURO. Thank you all for your testimony. And let me just 

ask a couple of questions if I can. 

I am going to start, if I can, Mr. Levinson, with the recommendations. I will ask our other two panelists to comment as well, because I am going to try and make my way in a number of rounds 

to deal with the recommendations and see where we go. 

Excuse my voice, I have laryngitis. It is been about a week now. 

So, in any case, it is a little squeaky. 

The first recommendation that is made is that FDA should seek 

statutory authority, if necessary, to strengthen existing requirements related to lot-specific information, specifically, to require 

processors, packers, manufacturers to create and maintain lot-specific information and extend it to all entities not required to maintain this information. 

Now, to be clear, you are recommending that lot codes be mandated for all products and that all persons be required to maintain 

those codes for all products under FDA’s jurisdiction. Is that correct? 

LOT SPECIFIC INFORMATION

Mr. LEVINSON. We are talking about lot-specific information with 

a recognition that lot-specific information may, in terms of the 

technology, involve a variety of approaches. And I would ask my 

colleague, Jodi, to talk more about that. 

Ms. NUDELMAN. The other thing, from the study, we are not 

making any comments about farms. So in our study, we are saying, 

to extend the requirement to keep lot-specific information to distributors, wholesalers, storage facilities, and the retailers. But from 

the extent of our study, we could not make any comments on 

farms. 

Ms. DELAURO. Or foreign entities? 

Ms. NUDELMAN. Correct. That was the limitation to our study. 

We traced these 40 products back to the border or to the source, 

and it did not include any foreign entities. 

Ms. DELAURO. Restaurants were exempted as well; is that right? 

Ms. NUDELMAN. Correct. 

Ms. DELAURO. So it is restaurants, farms, and the foreign facilities? 

Ms. NUDELMAN. Correct. We cannot speak from them. 

STATUTORY AUTHORITY

Ms. DELAURO. Let me ask you this question. Why do you suggest 

that statutory authority might be needed for this? Did FDA suggest 

that to you? And for what parts of the proposal do you think legislative authority would be needed? 

I ask this because you are talking about statutory authority, 

again versus regulatory authority. And we did deal with a rule— 

I have comments on the rule and where we weakened the rule before, but there was a rule-making authority that the Agency had. 

But here you are suggesting that there be, again, as I say, a statutory authority. Can you explain why? 

Mr. LEVINSON. Well, I think we have included that without necessarily, as an office, opining on whether that authority already exists or not. And not serving as the chief legal officer of the DepartVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00025 Fmt 6633 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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ment and having gotten the sense that there is, at least historically, some uncertainty about how far the original 2002 law goes 

in the kinds of authorities we are talking about, our purpose really 

was to take this very important, we thought, snapshot of the historic record when it came to what has transpired since the passage 

of the law and the regulation. 

And noting how nearly 60 percent of those we contacted were not 

in compliance, and with one out of four not even knowing about 

compliance, we certainly felt strongly that Congress needed to revisit this. And if, indeed, there need to be some statutory changes, 

it would be certainly timely. 

BIOTERRORISM ACT

Ms. DELAURO. Well, I will make the point here about the earlier 

rule, which were the limitations of the Bioterrorism Act; because 

at the outset, it was more fulsome, if you will, than what it turned 

out to be, and farms totally excluded, all foods under the exclusive 

jurisdiction of USDA totally excluded, restaurants totally excluded. 

Access to records, FDA must have reason to believe that food is 

adulterated and that it presents a threat of serious adverse health 

consequences or death to humans or animals. 

And the final rule was weaker than what the draft rule was. I 

mean, this was in the act, if you will. But then, you know, the final 

rule was weaker than the draft rule. 

All foreign persons except those transporting food in the U.S., 

were excluded. And at the time, OMB estimated that it exempted 

about 225,000 foreign entities, even though it said that the large 

number of excluded foreign entities increased the likelihood of 

hampering trace-back investigations. 

The requirement to keep a record of lot-specific information, 

which applies to all entities, was limited to manufacturers, processors, and packers in the final rule. And yet, again, OMB said 

that the reduction in benefits from doing so was high, estimated 

that the length of trace-back times would be sharply higher under 

the final rule than under the draft rule. 

And there was a change in that the requirement to make records 

available to the FDA in a food emergency was changed from 4 to 

8 hours, to not to exceed 24 hours. And then all retail outlets with 

fewer than 10 full-time-equivalent employees were excluded. 

I am just going to ask, I understand the issue of the high cost 

on other firms, if they—you know, a number of these folks were included, but it is estimated that trace-back times for many of the 

products would be 1 to 14 days, with all parties keeping code 

records, compared to 6 to 8 weeks without all companies keeping 

them. And that was really known at the time, and so forth. 

I want to ask our two other panelists—I know my time has expired, but very briefly—not to comment on statutory versus rulemaking, but just on strengthening the existing requirements with 

regard to lot-specific information, if you could briefly comment. 

Craig. 

Mr. HENRY. Thank you, Madam Chairwoman. 

I think the best person or best entity to address the value of it 

is certainly FDA, and I think that Mr. Levinson qualified that in 

his statement. 


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STRENGTHENING TRACEABILITY THROUGH THE SUPPLY ACT

As I stated before, in order to address traceability and strengthening it through the supply chain, responsibility needs to be levied 

at all levels. As the testimony, I think, across the board today 

shows, there are two primary directions that we must be focused 

on. One is certainly the upstream, which gets back to the source 

of the contamination, and that needs to happen with rapidity. The 

downstream is going to be the turnabout, once you know where it 

is coming from. 

Now we have to get to the consumer’s pantry to build their confidence as quickly as possible. If there is a breakdown in not being 

able to identify a particular product by lot code, either for the consumer or for the person vending that product, there is now a gap. 

And I think that is very evident in the survey that the IG has 

quoted. 

And then I would default, I think, to Tom, because his process 

does speak to the entire trackability or traceability all the way 

down the system. 

But I would also like to qualify and bring the subcommittee’s attention to the idea of interoperability. It is not as easy as it sounds. 

And GMA fully supports the need to focus in on the pilot program, 

the pilot study, so that we can define from the bottom up what is 

practical, what is feasible, what is cost effective; and make sure we 

are getting the response we need, an end result which is better 

consumer confidence and safer food products. 

Ms. DELAURO. Tom. 

Mr. STENZEL. In my layman’s opinion, I would suggest a rulemaking issue, even though you have asked us not to comment on 

that. 

Ms. DELAURO. Well, I am happy to have you comment because 

we apparently have the ability to do that. 

Mr. STENZEL. I believe so. 

The two key aspects, I think, for the produce industry—the farm 

exemption I don’t think is a problem; I think it is still appropriate. 

In our case, the product is sent to a first handler, the person who 

packs the box, and it is that person’s responsibility to maintain the 

lot information, where it came from. So having a set of records at 

the farm level would probably just be a duplication of what it goes 

through at the packer level. So we think that is acceptable. 

On the question of FDA access, other than when they suspect 

that there is a contamination problem, we do think that is important. FDA should be able to go out and look at records now when 

there is not problem and help find those problems. 

Ms. DELAURO. Mr. Kingston. 

Mr. KINGSTON. Thank you. I am going to yield to Ms. Emerson 

for right now and then come back, because she was here first. 

Ms. DELAURO. Yes, she was. Ms. Emerson. 

Mrs. EMERSON. Thanks, that is great. I appreciate it. 

Thank you all so much for being here, Madam Chairman or 

chairwoman or chair—I don’t know what to call it. 

Ms. DELAURO. It makes no difference. 


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TRACEABILITY REGULATIONS

Mrs. EMERSON. Mr. Levinson, I want to ask you about the 

traceability regulations you tested in this study and which were required by the Public Health Security and Bioterrorism Preparedness and Response Act. 

The authorizing language gives the Secretary authority to access 

records when there is a belief the food has been adulterated and 

threatens public health. Your testimony states a concern for the 

thousands of Americans who have become ill after eating contaminated food and beverages. 

In your opinion, is the fact that the authorizing language refers 

to adulterated food and was included in the Bioterrorism Act relevant to the purpose of the regulations? And, essentially, is the authority granted under the Bioterrorism Act to respond to adulterated food broad enough to cover all discovered food-borne illness, 

or should it be limited to terrorist incidents? 

And then my last question about this subject is, should we be 

trying to patch together a traceability system from a Bioterrorism 

Act, or should we start with a whole new public law, as Rosa kind 

of referred to? 

Mr. LEVINSON. Mrs. Emerson, we, as an office, like virtually 

every OIG office in government, doesn’t try to serve as a policymaker to advance a particular policy proposal. This study came 

about, in large measure, because in talking with FDA, FDA itself 

told us it was unsure as to whether there was enough compliance 

with being able to know, when it comes to food traceability, whether it would be possible to trace foods subsequent to the 2002 law. 

And we actually moved from one project to this one, sharing 

their concern that this looked to be a pretty important matter. 

I would leave the science, really, to others as far as contaminated 

versus adulterated, but I think we move forward on the study on 

the assumption that the law, as passed by Congress, envisioned the 

ability in a food emergency to be able to trace food in a way that, 

given these results, indicate that we don’t have the compliance that 

was envisioned by Congress. 

Mrs. EMERSON. Well, it certainly seems that—and obviously this 

is not your fault, and we are happy that you found it. But when 

you consider that only 5 of 40 products were traceable, to me, that 

is a pretty disappointing record of compliance. And with only 2 of 

the 38 facilities having lot-specific information, it does suggest that 

we have a significant issue with enforcement. 

Am I mistaken in that? 

ENFORCEMENT

Mr. LEVINSON. Well, with respect to enforcement, I think one of 

the hurdles that exists in the structure now is that the FDA can 

take action on the criminal side if it believes that there has been 

a failure to adhere to the requirements of the Food, Drug and Cosmetic Act. 

That is almost too severe a regulatory regime, if you will. And 

it would actually be helpful, as per our recommendations, to think 

about a compliance regime that wouldn’t put FDA to the test of 

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perience indicates that there is a lot of noncompliance that has 

nothing to do with some kind of criminal motive to evade the law. 

Mrs. EMERSON. So fines, or something like that, might be better? 

Mr. LEVINSON. This is a good time for Congress to revisit this 

provision. There are many areas of human endeavor where 7 years 

doesn’t make a whole lot of difference, but when you consider 

where we were as a nation, and in this area of information technology in 2002 and where we are today, and I think the conversation about the GS–1 data bar is a good example of how things continue to evolve in IT at a very rapid rate. 

We have talked about health IT for these last few years, we obviously now are in the world of food IT. And things are moving rapidly enough that these are the kinds of issues that perhaps can be 

grappled with in a much more cost-efficient way than perhaps 

could have been done historically, making the revisiting of this 

issue especially timely today. 

Mrs. EMERSON. Okay. It looks like I am out of time. Thank you, 

Madam Chair. 

Ms. DELAURO. Thank you for the questioning. And I just might 

say that technology has moved ahead, yet we haven’t moved ahead 

with public policy. 

But, also, there needs to be a monitoring system that exists. You 

can have the information, but not be able to do anything with it, 

which is where we are at the moment in whatever the information 

is. As limited as it is, there isn’t any way to track or to monitor 

anything that is happening. 

Mr. Bishop. 

Mr. BISHOP. Thank you very much. This testimony is very fascinating and I think it is very timely. And I want to thank you for 

the information you are bringing to us. 

FUNDING LEVELS

Dr. Levinson, from your perspective as the IG, I am interested 

in whether or not, based on your study and your knowledge, you 

feel that FDA has sufficient resources and tools at this point in 

time to accomplish—let’s assume that we are able to tighten up the 

traceability and give what is necessary for that, do you have the 

necessary personnel, do you have the necessary laboratories, the 

equipment? 

Is your organizational structure such and are you staffed such 

that adequate time and effort can be placed on the food safety 

issues that we are concerned about, as opposed to your other responsibilities with drugs? 

And are you in a position to say that Congress needs to look at 

perhaps some reorganization in terms of how those responsibilities 

are handled and how the resources are allocated? Because, as I understand it, USDA, with meat, fish and the poultry, has many 

more inspections, many more personnel available per facility, than 

FDA does on a ratio basis. 

So tell me about that, about the resources, the organization, the 

structure, do you have what you need, or do we need to look at trying to provide some additional resources? 

Mr. LEVINSON. Mr. Bishop, this particular study was not undertaken to look at FDA in any global way and, indeed, it is one 


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among at least a dozen reviews of FDA work that the OIG has 

done over the last few years in specific areas. We really don’t 

serve—we wish we could, perhaps, in a more ideal world, but given 

our own resources, if you set aside Medicare and Medicaid, as an 

office we have about $40 million to oversee over $100 billion of 

HHS programs. And therefore, we do our own cost-benefit analysis 

of what we are going to look at. 

We have looked at this particular area, and we really can’t speak 

to the overall picture of FDA. We certainly, in the course of the reviews we have undertaken of FDA work, we have revealed, surfaced a number of recommendations for change that we would 

strongly—— 

Mr. BISHOP. I am not sure that I understand from your rhetoric 

the answer to my question. What I want to know is, do you have 

enough resources? Do you have enough funding? Do you have 

enough staff, anything else that you need to satisfy the American 

public, to satisfy the Congress that you can do what is necessary 

to keep our food safe? 

And if you don’t, tell us, so we can try to make provisions so you 

can have what you need. But if you don’t tell us what you need, 

we can’t provide it. 

Mr. LEVINSON. I understand and I appreciate the question. 

Mr. BISHOP. Having done all of these studies that you are talking 

about, and as the IG, you have to look at the whole Agency. And 

looking at the whole Agency, you have to know whether you have 

to make, as you say, cost-benefit analysis decisions on how you use 

the $40 million of resources that you have. 

So if that is not enough, tell us. If you need more people, tell us. 

If you need more authority, tell us. 

Mr. LEVINSON. Well, we are very grateful for the funding that 

the OIG does get at HHS, and we would need— 

Mr. BISHOP. Is it enough? 

Mr. LEVINSON. We are certainly stretched with the responsibilities that we have. But I think what you are getting at, really, are 

the resources of the FDA, not so much the resources of the OIG. 

And with respect to the resources of the FDA—— 

Mr. BISHOP. That is what I am asking. 

Mr. LEVINSON. Yes. In the first instance, it is important to have 

that question posed to the FDA. 

Mr. BISHOP. I am sorry, I didn’t mean to be ambiguous. I thought 

that you were the OIG for the FDA; is that correct? 

Mr. LEVINSON. Well, the FDA is one of 300 programs and agencies of HHS—— 

Mr. BISHOP. The HHS, okay. 

Mr. LEVINSON [continuing]. That the OIG, as an independent 

body, looks at. So we do consider the FDA part of our oversight responsibility, and we feel an important responsibility to report to 

Congress on what we find when we do reviews like this of FDA operations. 

But we think it is very important that you have an opportunity 

to pose exactly that question to the FDA when the opportunity presents itself. 

Mr. BISHOP. We will. 


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Ms. DELAURO. I can’t let the moment pass. It is one of the reasons why we should have a food safety agency that is independent, 

because then it would have its own IG. And I am not saying that 

you haven’t done your job, you have done a great job, but it would 

be a different set of circumstances. 

Mr. Kingston. 

Mr. KINGSTON. Thank you, Madam Chair. I want to just walk 

through some numbers to make sure everybody keeps something in 

perspective here. We certainly want to do everything we can on 

food-borne illnesses, to attack this, but frequently in politics we 

concentrate on the factor of fear, to use our own positions to get 

reelected and prove our own importance. 

These are facts. This is a number—and of course if anybody can 

dispute it, that is what we are here for, but as I recall, 76 million 

people a year get food-borne illnesses. According to our testimony, 

Mr. Levinson, 300,000 get hospitalized, 5,000 die. 

Big number, 74 million, but if you look at eating three meals a 

day, supposing we never have snacks, 300 million people in the 

population of the United States, 365 days a year, if you divide that 

76 million by that number, you are talking about a .002 percent in 

terms of food illnesses—the point being, we have a remarkably safe 

food supply. 

And we need to keep that in mind, that there are a lot of things 

out there working—no thanks to the Federal Government; it is 

there because the private sector works. They have an incentive to 

have their customers keep buying from them because dead customers don’t return. 

And so we need to keep that in mind. Sometimes we just continuously beat ourselves up and spend a lot of money. 

I want to pick on my friend’s testimony—not my friend, Mr. 

Henry, but I want to pick on GMA a second. 

FDA FUNDING LEVELS

In terms of FDA funding, do you know how much of an increase 

they got last year? 

Mr. HENRY. Mr. Kingston, I believe that they got—I am going to 

say close to $100 million. I know we were originally proposing, in 

the coalition, a $200 million increase over a 5-year period. And I 

did not bring that number with me, but I want to say that—for 

sure, I know they got $40 million, but I don’t know exactly what 

that number is. 

Mr. KINGSTON. Actually, it was about $200 million in the supplemental and then in the omnibus—— 

Ms. DELAURO. Three hundred million total. 

Mr. KINGSTON. Three hundred million. 

Now, that being the case, your first recommendation was to give 

a comparable increase. If you thought it was 100, and you are 

shooting to double that to get to 200, and now that we have told 

you it is over 300 million, should we drop this recommendation 

from your testimony? 

Mr. HENRY. No, absolutely not. 

Mr. KINGSTON. The sky is the limit when it comes to tax-funded—there is no deficit problem here. 

Mr. HENRY. Right. 


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Mr. KINGSTON. Okay. I just want to say the FDA got a ton of 

money in the last cycle. 

COMPETENT HANDLING OF FDA

Do you feel that they competently handled spinach, tomatoes or 

peanut butter? 

Mr. HENRY. I believe that they handled those issues as effectively 

as they could with the resources that they were able to apply at 

the time, yes. 

Mr. KINGSTON. You know, there was a lot of collateral damage, 

millions of dollars lost by innocent, law-abiding farmers and producers because of, you know, tomatoes, peanuts, and there is no 

compensation for those folks. 

Mr. HENRY. No. 

Mr. KINGSTON. I think one of the things we have to focus on is 

not just giving FDA more money, but giving them more competency 

in terms of using the technology that is out there today to rifle-shot 

rather than shotgun and go through the world scaring everybody. 

And I am looking to GMA to be helpful on that. 

VOLUNTARY VS MANDATORY RECALL

Now, the other thing is—two more criticisms to my friends at 

GMA. You have an Orwellian statement in here that I have got to 

take exception to: ‘‘Give FDA mandatory recall if a company has refused voluntary recall.’’ There is nothing voluntary about it if they 

refuse to do it and then they are going to have mandatory recall, 

right? 

Mr. HENRY. Yes. According to the current programs, it is a voluntary action for a manufacturer to issue a recall. And at this particular time, except for infant formula, FDA does not possess the 

authority just to go in and execute on their own, so they take the 

next action, which is to put out an alert, and then work with the 

States to actually, if you will, control the distribution of that product in the marketplace. 

So you are right, it is mandatory and voluntary in the same 

statement, but we are saying, Look, if the voluntary action, which 

is the option of the manufacturer, is not exercised and there is serious threat to human life, then FDA should have that mandatory 

authority where they can come in and say we are going to execute 

a full-blown recall. 

Mr. KINGSTON. But I think we need to be frank and say that it 

is mandatory, rather than mandatory if they refuse the voluntary. 

Because it is just so Orwellian for us to be living in a government 

that talks like that. 

Mr. KINGSTON. Last criticism. When you say you seek swift improvements, we all get frustrated when we want swift stuff, but 

swift action sent formaldehyde-laden trailers to the gulf. Swift action got us into a war looking for WMD. Swift action rushed a 

TARP program through that allowed AIG to have lots of bonuses 

and other unintended consequences. So sometimes slow deliberation is important. 

An example, I think HACCP has worked actually fairly well on 

food safety, and that was a slow piece of legislation that went 


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through the process, but I think through that there was a lot of 

vetting. 

But also, as Mr. Levinson has pointed out, technology is just 

moving at a remarkably fast pace, that there are so many more 

tools now that we would not have had 4 years ago. This Universal 

Products Code thing that I hadn’t seen before, I don’t really like 

those little stickers on my apples because I have got to peel them 

off, but this one kind of makes sense. 

I know I am out of time and I yield back. 

Ms. DELAURO. Thank you very much, Jack. I just think it is interesting, with your first comment with regard to the numbers, it 

winds up being about one out of four Americans who get sick when 

you take a look at those numbers and you try to break it down, 

which I think is significant. If you take a look at this, it is one, 

two, three, four, and you go down the list here, it goes through— 

and the other thing is I think your point is absolutely right about 

what has happened to the industries, which is why we have had 

such an outcry. 

But when you think about the last peanut butter outbreak, nine 

people died. Some child, some mother, some relative of someone 

died because they ate some peanut butter-based product. Who 

could have thought that peanut butter would be an at-risk food, 

given the process. So it has very some very, very broad ramifications. 

Let me look at the second recommendation. It has two parts. The 

first in the set is that each facility that handles a food product 

maintain records about every facility or farm that handled the 

product along with relevant lots. Typical information. 

RECORDKEEPING REQUIREMENTS

To be clear, does your recommendation mean that the retailer 

would ultimately need to keep records about all the steps—growing, packing, processing, shipping—of every product that it sells? 

And since your report indicates that there are problems in implanting one-step-forward, one-step-back traceability, do you think that 

this is realistic? And which lot-specific information do you consider 

relevant? 

Mr. LEVINSON. Madam Chair, I am going to ask my colleague to 

respond. She has done such extraordinary work on this and I want 

her to have an opportunity to inform you about this. 

Ms. DELAURO. Okay, Jodi. Go ahead. 

Ms. NUDELMAN. I think you are referring to our second recommendation where we are saying—beyond lot-specific information, we are saying more of a type of system where—and we are 

making suggestions for FDA to consider in this area, but to use the 

technologies we have been talking about, to have standards set 

where in electronic format there would be the type of information 

that could be standardized across industries so that could be eventually—— 

Ms. DELAURO. It would—— 

Ms. NUDELMAN. That is one of the possibilities we are offering. 

Ms. DELAURO. It would appear that the proposal would seem to 

put the ultimate burden of traceability on the retailer. Is that accurate or a misreading? 


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Ms. NUDELMAN. That is not what we meant there. We had meant 

there for FDA to think about broader things here. So to go beyond 

the one-up/one-back rule, to talk about technologies that could be 

linked so that the product itself could be traced back through each 

stage of the—— 

Ms. DELAURO. But you are talking about the retailer keeping 

records, correct? 

Ms. NUDELMAN. Correct. 

Ms. DELAURO. Of all of the steps. 

Ms. NUDELMAN. We are offering a couple of combinations here, 

so we are not being very prescriptive in this recommendation. We 

are saying that because we know that there are a lot of technologies out there, the industry has some new thinking. We are 

leaving this one open and saying, but it is time to think beyond 

keeping one-up/one-back. It is time to think of systems that could 

be interlinked, interoperable systems that would allow for 

traceability through each of the stages. 

Ms. DELAURO. It just seems to me, though, that that does lead 

to the retailer in the way in which you would have to do all of that, 

and the retailer having that complete set of information. It almost 

appears to eliminate the need for traceback since the retailer would 

have that information. 

But also I don’t know what your sense was in terms of retailers. 

Are they adequately equipped to establish and to maintain the 

records? And I don’t know what you turned up in your findings 

with regard to that. 

Ms. NUDELMAN. Again, as you alluded to, though, the sample 

size that we were looking at was pretty small. But from that we 

could tell a number of the retailers weren’t even aware of some of 

the requirements to maintain records just about their sources. So 

that was one of the things we brought to FDA’s attention in this 

report; that they need to provide some further education in that 

sense. 

TECHNOLOGY FOR RECORDKEEPING

Ms. DELAURO. Okay. The second recommendation is that the 

FDA should require facilities to use certain information technologies to help facilitate recordkeeping. Which technologies did 

you have in mind? Do they currently exist, or would we have to establish them? 

Ms. NUDELMAN. Again, this is what I was alluding to in the first 

point where these technologies were referenced earlier that could— 

if you provide certain standards that could be in electronic format, 

which is one big jump here, because we did find a lot of paperbased records; so in electronic format, where people are keeping the 

same type of information and that information could then be linked 

across specific facilities here. So, again, we are not being overly 

prescriptive. We know that others have looked at it—— 

SAVED TIME

Ms. DELAURO. Just a final question. Do you have any estimate 

of how much time, in terms of what you looked at, the FDA might 

save in tracing products if you dealt with the new technologies? 


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Ms. NUDELMAN. We did not track the time of the products that 

we traced. At the same time, when facilities did have something 

electronic, they could immediately reference it and get to the source 

that we were asking for for a specific product. I mean, other just 

anecdotal evidence was that some facilities needed to look through 

stacks of paper or they would have part electronic, part paper, that 

didn’t talk to each other. So I think it could be quite substantial. 

Ms. DELAURO. I will just leave it with this. If you do have other 

approaches that you thought about besides what you have mentioned that you think would be beneficial, we would really like to 

know about what your views are on that. 

Mrs. EMERSON. Mrs. EMERSON. Thank you, Madam Chair. 

Was it you, Mr. Henry, who mentioned that there really isn’t any 

interoperability? You are the one who said that; that is correct? 

Mr. HENRY. Yes. 

COST FOR INTEROPERABLE SYSTEMS

Mrs. EMERSON. How much do you all anticipate it would cost to 

put together an interoperable system? No guess? 

Mr. HENRY. No guess. It is a real challenge. And I think Tom’s 

program that he has proposed lays the foundation and the system 

that could allow that to happen. 

One of the things that I brought with me in anticipating that, 

this is an excellent support document to Tom’s testimony. This was 

just released from GS–1, which is a standards organization for 

traceability, but this was released in February of 2009 that addresses the particulars on that. 

Ms. DELAURO. Would the gentlewoman yield for one second, just 

to add, if you wouldn’t mind, to your question about just sharing 

this issue of the lack of interoperability here. Just define that. That 

would, I think, be helpful to everyone. 

DEFINITION OF INTEROPERABILITY

Mr. HENRY. Okay. The challenge when you develop a traceability 

program is there are a lot of interested parties or stakeholders 

there. You have the person that is supplying the ingredients, the 

person who is constructing the product, you have a distribution 

chain. You have got a first, second, or third-stage retail. Then you 

have got beyond what we would think to be the grocery store, down 

to other brokers, et cetera, et cetera. 

Everyone has a different need for the information they are harnessing; therefore, they will develop their own coding system. They 

will adopt proprietary systems. GS–1 is a proprietary system. 

When they adopt that, it is only for their needs, not for everyone 

else’s. So if I create a system that I manufacture a product for 

Tom, but Tom is going to retail that, if he doesn’t have the scanning equipment, the databasing equipment to capture what I put 

on mine by electronic form, then he has to do it in written form. 

Which is exactly where the IG’s report is going. 

So when you do not have that interoperability—and I am only 

one supplier, so if everyone in this room was supplying Tom as a 

retailer with, let’s say, 50,000 different products and we all were 

not unified in the coding system that we used, as well as the readVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00035 Fmt 6633 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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ability of that code, be it electronic or even manual, now you can 

see where the problem develops. 

Mrs. EMERSON. How does the EU do it? 

Mr. HENRY. Pardon me? 

Mrs. EMERSON. Does the European Union have traceability? I 

think that they do. 

EUROPEAN UNION

Mr. HENRY. Well, they do. And this is one of the things—right 

now globally, and especially over in the EU, Kodak, of course, has 

traceability foundation and guidelines. Various countries, which 

some of those are enumerated in this report here, do speak to how 

they approach traceability. They are all still trying to struggle with 

the interoperability challenge and the cost. Especially when you 

really look at this, when we get down to traceability in the finest 

tune, we really are looking at the lowest common denominator. 

Now, one of the things I was not able to ferret out from the IG’s 

report, or the survey, was specifically at what level of the food 

chain were some of these facilities, in quotes, really affected? Was 

it, you know, the mom-and-pop operation who is doing a small operation where they don’t have a lot of money. You know, they may 

all be paper based. 

So we need to look at that level, because if we really want to improve recall and get the product out of the system, it has to be the 

lowest common denominator. 

Mrs. EMERSON. I appreciate that. If we can’t still get our first responders to be interoperable, I don’t know how the heck we are 

going to get you all to be, but—— 

Mr. HENRY. I hope I didn’t complicate that for you. 

Mrs. EMERSON. No, you didn’t complicate it at all. That is the 

bottom line. I appreciate your answer, although I guess it is just 

one more set of challenges with which we must deal. But thank 

you. 

FDA AUTHORITY TO REQUEST RECORDS

Mr. Stenzel, I want to ask you about your comments regarding 

highly visible action when an outbreak occurs and companies aren’t 

in compliance. Would you support increased authority for FDA to 

request facilities records at any time, as recommended by the IG? 

I mean, is there any reason that FDA should wait for an outbreak 

to determine compliance, or is it better just to perhaps do a spot 

check here, a spot check there? 

Mr. STENZEL. Congresswoman, two parts to your question. If 

there is an outbreak and they find someone not in compliance, then 

that is the highly visible action. 

On the former question, should they have access to records to see 

if people are having one-step-up/one-step-down compliance, we believe they should; that that is a rulemaking issue. It probably 

ought to be part of a standard FDA inspection when they are looking at facilities to check on their traceability compliance. 


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INDUSTRY EDUCATIONAL EFFORTS

Mrs. EMERSON. I appreciate that. Having worked myself at a 

trade association in my past life, one of the big components of that 

was doing an educational program to help the industry comply with 

different standards, FDA or OSHA or whatever. What educational 

efforts do you all do to raise industry awareness of their legal duties in this regard? 

Mr. STENZEL. Well, we are certainly starting more in recent 

years than we used to do, quite frankly. And I think seeing the results of the IG’s report, although only a few of those were produce 

items, it does make me think we have a responsibility to get out 

and do more education. 

I mentioned in the whole chain traceability, the interoperability 

that our industry is launching, that is where we are putting most 

of our focus right now. But perhaps there is a remedial step as well 

on simply compliance with the current rules. 

Mrs. EMERSON. Thank you. Thanks, Madam Chair. 

Ms. DELAURO. Mr. Boyd. 

Mr. BOYD. Thank you, Madam Chair, and thank you for holding 

this hearing. Ladies and gentlemen, thank you for being here. 

First of all, I come from a place where I have long held the belief 

that we have the most adequate and safest and least-expensive 

food supply in the world. And there are some things that have happened, obviously, in the last several years that have begun to crack 

that belief of mine and go into it and make me doubt it. 

First of all, I want to tell you that I come from an agricultural 

producing area and the last two most serious scares, the tomato industry—I have a major tomato industry in the district I represent 

that was literally destroyed. The industry, the farmers, were destroyed by that incident. And I also come from a large peanut producing area, which is now probably going to be seriously set back 

because of market effect of what has happened here. I think there 

are two reasons for the erosion of that confidence that I have. 

Number one is that we have, as we have gone over the years to 

open our borders and rush to do trade agreements, that we have 

not kept our safety systems up with stuff that was coming in from 

other places, as well as we should. 

And, secondly, this 24-hour news cycle. So when you have somebody that gets hurt, everybody knows, it and it just totally obliterates the market. 

I am going to get to my question, but I want to set that up for 

you to tell you that the tomato issue, as I know it today, still has 

not been nailed down by the Food and Drug Administration as to 

where it happened and what the product was. As a matter of fact, 

they probably pretty much concluded that it was not tomatoes. It 

was peppers in Mexico; am I right or wrong? 

Mr. HENRY. Yes. 

Mr. BOYD. Okay. Now, I believe also that when you take a taxpayer’s—the dollar out of his pocket and say you are going to protect the consumer with it, whether you do it at the local, State, or 

Federal level, that money comes from the same place. The most effective place to do all of this is closest to the consumer as you can 

get. 


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Every State, all 50 States, have a consumer advocate food safety 

component in their State bureaucracies, right? I assume there is 

nobody out there sent from a State agency on this issue that has 

jurisdiction over food safety. 

INTERACTION WITH STATE AGENCIES

Now, Mr. Levinson, I have read your report or briefed it. I don’t 

see anywhere in it where we have talked about interaction with the 

State agencies and use of their assets, their infrastructure, their 

people, their expertise, their knowledge. I have had several communications with my State agency folks, and not only did I find out 

that they weren’t asked to be part of any of these investigations by 

FDA, in fact they were intentionally not shared information from 

the FDA. And they had access. My State agency had access to information which would help the FDA do the traceback. 

Mr. Levinson, did you address this? Can you speak to it? And I 

would like for you to speak it and also maybe one of you folks from 

the private sector, too. 

Mr. LEVINSON. Mr. Boyd, we have actually been asked by the 

Chair to look at the State inspection agencies, and we have work 

that we are in the middle of right now preparing for that specific 

request. This study is separate from that in the sense it was designed to see what the state of recordkeeping was pursuant to Congress’ law back in 2002. 

But you raise an important, valid, and a very timely issue; and 

we are actually engaged, per the Chair’s request, in that specific 

project. 

Mr. STENZEL. Mr. Boyd, if I could share a perspective also on behalf of those tomato growers in your district. There was a tremendous amount of information that was not brought to bear during 

the investigation that would have helped in the traceback. We 

think that is one of the most serious issues we have got here is just 

what the IG has done, is start these traceback exercises now. Let 

us do them now. Let us bring the State and locals and FDA and 

CDC together and learn the process, bring the industry into this 

process. 

Very quickly, we knew that tomatoes were not the source. We 

knew they were tracking back to different farms. There wasn’t a 

common point. But we couldn’t move the agency away from that 

conclusion until very, very late in the game. But I think if we could 

do more of these traceback exercises today, we could bring some of 

that expertise you are describing that exists not only in State and 

local governments, but in industry. 

Mr. BOYD. Thank you. 

Madam Chair, I know that you are going to focus on this issue. 

You have, and rightfully so, and I assume you will continue to. 

Can I request of you and the committee that we at least get some 

of those—I would like to have—since Florida, and now Georgia 

with your plant down there, your plant that buys my peanuts—it 

wasn’t ours. It was the ones that you shipped in from China that 

caused the problem. I want everybody to understand that. 

So if we could have some State agencies come in here, and FDA, 

and put them in the same room and maybe some industry folks, 

too, with them—have them talk to each other about their inability 


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to communicate with each other and to work together, share information; because, you know, Madam Chair, when you take the dollar out of the pocket of the taxpayer, he is funding both of those 

agencies and then didn’t—not only did he not get his money’s 

worth, it was counterproductive. They put him out of business for 

something he didn’t do. So I would like to work with you on that. 

Ms. DELAURO. I am more than happy to do that. I think it is just 

critical that wherever we move forward, that even with the State 

laboratory systems, the State agencies that have these responsibilities, they need to be looped into this; because there is a lot of expertise at that level which is now not being used. 

I mean, quite frankly, Minnesota—the folks in Minnesota did an 

incredible job of identifying where the issue was and, unfortunately, with regard to tomatoes—and you were here, I think, at 

this last hearing that we had here, where they were still being let 

out on their own recognizance. Nobody has finished that up. So it 

continues to put the tomato industry in jeopardy. So I am happy 

to work with you. 

Mr. BOYD. Thank you, Madam Chair. 

Ms. DELAURO. Mr. Kingston. 

INCREASE IN FDA FUNDING

Mr. KINGSTON. Thank you, Madam Chair. I wanted to first of all 

say for the record, particularly for my friends at GMA, that FDA 

since fiscal year 2008 has had a 19 percent increase. They have 

gone from a budget of about $1.7 billion to over $2 billion; $150 

million in the supplemental in June of 2008 and $150 million-plus 

in the CR. If they needed—I mean, which is more than the money 

level you have been asking for. So I am not convinced money is 

their issue. 

But I wanted to move in a different direction. Mr. Levinson, the 

300,000 people who are hospitalized, I would like to know the 

breakdown of how much of that was in the commercial arena and 

how much of it happened at home in terms of when the food may 

have gone bad? Don’t you think it is relevant to the discussion? 

Mr. LEVINSON. That is a number from the Centers for Disease 

Control and Prevention. 

Mr. KINGSTON. Can you get it? 

Mr. LEVINSON. We will be happy to drill down as much as we 

can—— 

[The information follows:] 

Response: I agree that this is an important part of the equation. The statistic you 

reference was contained in a CDC report entitled ‘‘Food-Related Illness and Death 

in the United States.’’ In that report, CDC researchers estimated that there are 76 

million illnesses, 323,914 hospitalizations, and 5,194 deaths attributable to 

foodborne illness each year. In order to arrive at this estimate, CDC researchers 

compiled and analyzed information from multiple surveillance systems and other 

sources. 

In this report, CDC did not attempt to quantify whether any of those foodborne 

illnesses, deaths, or hospitalizations were linked to a contaminated food product or 

improper handling of the food. In addition, the study also did not quantify the number of illnesses caused by specific types of food. however, CDC is currently working 

on estimates for the number of foodborne illness that are attributable to different 

food types. These estimates are expected to be completed later this year. 


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Mr. KINGSTON. Don’t you think that it is extremely relevant? Because if this is a food-handling issue, we need to know how much 

food-handling plays a part in terms of the homeowner. 

The other thing is, do we have a breakdown of vegetable versus 

meat, or just the type of food, because there again I would think 

that would be extremely relevant. And would you agree with me 

that that is extremely relevant if we have 300,000? 

Mr. LEVINSON. I think it is helpful to have more drilling down 

of the data than less, absolutely. 

Mr. KINGSTON. My good Chair never misses an opportunity to 

plug a single food agency. This is why we need it. 

And we may have a little overlap here, because what I do not 

like in this town that everybody is assumed guilty. And, you know, 

if we are talking 300,000 people a year being hospitalized, we 

should know a full analysis of where is it coming from. What if we 

found out it is 90 percent meat? What if we found out that it has 

happened because people are not washing the frying pan; the cold 

meat versus the cooked meat and things like that? That is extremely important. 

IMPORTED FOOD

The other thing is—and Mr. Boyd touched on it—how much of 

this is imported food? Because I am a little concerned about some 

of the issues on imported food that we don’t want to overreact and 

then have them shut down their buying our food from us; which, 

you know, in poultry country we are concerned about China and we 

are trying to balance that out. But I think we need to know that. 

And then in terms of if people are all complying by the—so let me 

conclude that. 

You will get me those breakdowns, right? 

Mr. LEVINSON. Yes. 

Mr. KINGSTON. Okay. And then if everybody was playing by the 

rules now that are on the books, how much would this be solved, 

some of this problem? Do we know? 

Mr. LEVINSON. If my colleague wants to venture an opinion, I am 

not sure we can necessarily provide some sure-fire conclusion as to 

a solution that obviously is aimed to such a large part of the economy and how that is going to be handled. I am not quite sure that 

anyone would be in a position to give any kind of final answer. 

Again, this report is taking a snapshot of what happened when 

Congress decided, again pursuant to an antiterrorism law, to help 

ensure a safer food supply. And I think these results indicate that 

that kind of compliance regime has not revealed results. But I can’t 

give you a going-forward conclusion as to what is going to work 100 

percent. 

Mr. KINGSTON. Okay. I know, Madam Chair, there are some people who haven’t had a shot at the panel. So I am going to yield 

back. 

Ms. DELAURO. Ms. Kaptur. We do have a total of seven votes. So 

Mr. Latham and then Ms. Kaptur. And I don’t know how much 

time is left on the first vote. Ten minutes. 

So, Ms. Kaptur, let us have you move forward. And then, Mr. 

Latham, let me see if we can get you in, and then others can go 

and start to vote, and then we will recess and we can come back. 


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I will be back and I am hoping others can come back. 

FOOD IMPORTS

Ms. KAPTUR. Thank you, Madam Chair, very much. 

Mr. Stenzel, can I ask you, in your association for all the food 

throughput that comes from United Fresh Produce, how much of 

it is domestic and how much of it is foreign—just ballpark—and 

which segment is growing? 

Mr. STENZEL. The good news in fruits and vegetables are both 

are growing, and it is not through our organization but just in consumption in the United States. Imported products counter-seasonal 

to that grown in the United States have been growing in recent 

years. More than 35 percent of the fresh produce would be imported. 

Ms. KAPTUR. Okay. In the community in which I reside, Toledo, 

Ohio, a number of our small markets go up to Detroit Farmers 

Market on any given day, purchase boxed items, and bring them 

back and distribute them. 

What percentage of those in the winter months would be grown 

outside the borders of this country? 

Mr. STENZEL. I would have to give you an estimate on that, but 

probably the majority. 

Ms. KAPTUR. That is what I think. That is my take on it, too. 

I wanted to ask a question about—I was reading in Mr. 

Levinson’s testimony here a statement, ‘‘Only 5 of 40 products we 

purchased could be traced through each stage of the food supply 

chain back to the farm or border.’’ And I wonder if you could comment on that, ‘‘or border’’? 

Mr. LEVINSON. Ms. Kaptur, we weren’t looking at foods brought 

in from abroad, so the study does not include traceability, if you 

will, offshore or, for that matter, at the farm, at the source. We 

went as far as either the farm or the border, and then we looked 

at traceability domestically within that context. 

Ms. KAPTUR. Didn’t those jalapeno peppers come from Mexico? 

From everything you know, Mr. Levinson—is it Dr. Levinson or 

Mr. Levinson? 

Mr. LEVINSON. It is mister. 

Ms. KAPTUR. Mr. Levinson, okay. Could you please tell us what 

can we do about that? From everything you know, from what you 

have studied, what could have prevented that in terms of 

traceability systems that could be put in place? 

Mr. LEVINSON. Ms. Kaptur, I guess that is why I am not a doctor. 

I really don’t—I really can’t answer that question in good faith and 

give you an answer that I feel in good conscience would be really 

responsive to what I think you are getting at. 

EXCLUSIONS IN THE BIOTERRORISM ACT

Ms. DELAURO. Marcy, I just would make this point, in all fairness to Mr. Levinson. The rule which came out with regard to the 

Bioterrorism Act, all foreign persons except those transporting food 

in the United States were excluded. The original rule had them included. When the final ruling came out it was excluded. 

So that is not—also, in terms of exclusion, farms are totally excluded. Foods under the jurisdiction of the USDA. Restaurants are 


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totally excluded as well. So there are certain categories of exclusion. And what the report reflects is what was included, in essence. 

So your question is very relevant and it is one to be asked about 

how to deal with this, but—— 

Ms. KAPTUR. It is so great that you are Chairwoman of this committee. It is just so great. 

I am thinking back to the strawberry situation also. That was 

from Mexico, and all these kids in Michigan got sick in our neighboring State. It probably came from the Detroit market and was redistributed. So, you know, we have got to do something about this. 

And the only comment, Madam Chair, as I end, is saying that 

the costs for some of this—also we have to think about how it impacts little local producers that are producing in our local communities and how we allow them to bring their product to market, and 

they are not a part of some big giant international corporation, and 

whatever regulations are adopted, how we have some sympathy for 

the small producer in all of this. 

Thank you, Madam Chair. 

Ms. DELAURO. Mr. Latham. 

Mr. LATHAM. Thank you, Madam Chair. And welcome, everyone. 

TRACEABILITY PRIORITIES

A consumer today can go to almost any grocery store in America 

and buy something that is ready to eat, made in China, and we 

really have no idea where that wheat came from, what kind of 

water was used in the cooking process there as far as the noodles, 

and they are in most of their ingredients. 

Considering whether you are comparing food safety systems in 

the U.S. or in China, and if Congress increases funding for the 

FDA—as has been requested previously—which is the highest priority, do you think, as far as inspection of that foreign food or the 

traceability system in grain? 

And I have got a question about traceability in grain, too. But 

where would you go? 

Mr. LEVINSON. Mr. Latham, I sense that there is probably some 

good expertise within FDA, because I have had a conversation 

about this with Mr. Acheson himself, who handles this area, and 

he is very familiar with the international regimes that kind of exist 

to watch over the food supply in Europe and elsewhere. And I certainly am eager to offer the technical assistance of our office, because this study was done by some outstanding evaluators in our 

own operation. I think that really requires additional expertise that 

is not in this room right now. 

COMMINGLED AGRICULTURAL PRODUCTS

Mr. LATHAM. Okay. Just coming from an agricultural area that 

produces huge quantities of grain—and apparently in your testimony you talked about how that, in a bag of flour, you can’t trace 

where the wheat came from to individual farmers. I mean, have 

you ever seen how wheat is handled or corn is handled or whatever? It is virtually impossible to trace back—— 

Mr. LEVINSON. Right. 

Mr. LATHAM. This would be extraordinarily expensive and unbelievably onerous. 


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Mr. LEVINSON. Mr. Latham, we are certainly keenly aware of the 

commingling challenge, if you will, and that when it comes to those 

kinds of foods it is really important. And, indeed, I think our recommendations reflect the need to work with industry to come up 

with a regime that isn’t impractical, unrealistic; that takes into account the realities of how life works with respect to those kinds of 

foods. Absolutely. 

Mr. LATHAM. Okay. I think we are very much out of time. 

Ms. DELAURO. We are going to recess subject to the call of the 

Chair, but we will be back. 

[Recess.] 

Ms. DELAURO. I am going to proceed. I am going to assume that 

there will be others joining. 

AUTHORITY TO REQUEST RECORDS

Very, very quickly, let me just say—because I think it was my 

colleague Mrs. Emerson who asked the question about FDA seeking statutory authority to request facilities records at any time, 

and currently they can only request the records if they have a reasonable belief that the food presents a serious threat to health. I 

think it was you, Mr. Stenzel, who said you believed they should 

be able to do this at any time. 

Mr. STENZEL. Yes, Ma’am. 

Ms. DELAURO. Mr. Henry. 

Mr. HENRY. We would concur. 

Ms. DELAURO. Mr. Levinson. 

Mr. LEVINSON. Good. Sounds to me, Madam Chair, good—— 

Ms. DELAURO. That is what your recommendation—— 

Mr. LEVINSON. Yes. 

Ms. DELAURO. Okay. I just want to make sure that we establish 

some principles. I will just try to put these things together. 

You mentioned with regard to—I have got to be honest with you. 

When we encourage FDA to develop additional guidance on 

traceability, I understand the language but I am tired of guiding. 

I want to try to regulate here. There is nothing wrong with guidance, but I think we need to look at how we try to regulate. 

THIRD-PARTY AUDITS

There was an issue about contracting with independent thirdparty auditors to monitor recordkeeping systems. I get a little bit 

nervous about that for self-serving reports and conflicts of interest. 

My view is that companies—why can’t companies do this themselves? Mr. Henry? 

Mr. HENRY. Yes, it can be done. The difference is in part there 

is what we consider first-party audits, which means I audit your 

own facility; second-party audits which I go, I am the buyer, and 

I audit my supplier, which has great value. There is value there. 

Now, again going back to the lowest common denominator, a 

smaller operator here in the United States doesn’t have certainly 

the wherewithal to send a member of their staff overseas to do 

those audits. The position GMA has tried to take on this, and 

working very closely with FDA on third-party certification, is that 

harnessing a third-party auditor—and, again, remembering the 

food protection program is focused on export to the U.S., or the imVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00043 Fmt 6633 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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porter side—being able to use, if you will, a third-party auditor 

who has been properly certified, at arm’s length, to evaluate accurately a foreign supplier has great value and great merit, especially 

for those manufacturers or buyers here that just do not have that 

wherewithal. And I think that is an excellent use of tax dollars because now you are having FDA at least bona fide the auditor who 

is executing as well as establishing some guidance for the criteria. 

Okay? 

Ms. DELAURO. Well, I think that means that there has to be 

some real oversight of that process. 

Mr. HENRY. I concur. And the oversight—— 

Ms. DELAURO. Otherwise—— 

Mr. HENRY. In fact, I have asked FDA in an upcoming Webinar 

we are going to do, the industry is very much interested to see how 

the shrimp pilot program works out, and we think that the walkbehind value is where the FDA, using their inspection which is 

part of the process to improve food safety, is able to back into that 

facility that, quote, is certified and confirm it, validate that it does 

meet the mark. 

Ms. DELAURO. I think the most recent example which really 

wound up with this peanut butter salmonella thing being almost 

a perfect storm was because you had—I understand the contracting 

out to the States for inspection, but one has to have a set of criteria 

in which you ask them to do that. But then you have to monitor 

whether or not they are retaining that criteria, and then you have 

to have some reports back. So if you find something, it has got to 

come back in some way. 

Tom. 

TRAINING INSPECTORS

Mr. STENZEL. If I could just add another factor here that I think 

is going to be important is the training of the inspectors themselves. And that is one of the things that you support in terms of 

a consistent national training regimen. So whether they are State 

employees or local or even third-party private, that they would 

have the same level of qualification. 

Ms. DELAURO. I think that is also true. I don’t know you would 

concur with the laboratories. I mean, these are qualified people, 

but we have to make sure that we have very trained and qualified 

people in those labs. You find it in Minnesota but, you know, you 

don’t find it someplace else and so forth. So my view is it ought 

to be looped into this process as well. 

CHOICE OF PRODUCT SAMPLE

A quick question on the products. How did you choose the products? That is a question that I have. We have got ice, manufactured ice. Look, I am a novice at this. Manufactured ice, why was 

it chosen? Inclusion of flour. What was the criteria? Did you give 

FDA the criteria? Did they give you the criteria? 

What was it with regard—because my colleague Mr. Kingston 

spoke about dealing with foods that have the highest risk as a way 

of trying to deal with this, and I think—were they considered with 

regard to their role in terms of causing a food-borne illness? 


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Ms. NUDELMAN. We developed a number of factors to pick—to select these foods in the end. We did consult with FDA, and so we 

were looking for relatively common sort of basic-type foods that had 

ingredients we could essentially trace, that weren’t overly processed so it would complicate the study. But they did sort of gear 

us towards food products that they were interested in knowing 

more about, that they were unsure whether they were risky or not, 

and then asked us for—in the case of tomatoes, to look at something that they considered quite risky. So it does have a combination of factors that we looked at. 

Ms. DELAURO. A final quick question with regard to that. If FDA 

did give you the list, did it include products that you did not trace? 

And if so, what were they and why did you not include them? 

Ms. NUDELMAN. It was more of a discussion with them. They did 

not select specific products that we then chose from. We came together. We said that we were considering these types of products. 

They geared us towards particularly looking at the eggs. They had 

asked us to include that at the very end. So it was a consultation 

with them is how I would pose that. 

Ms. DELAURO. Mr. Kingston. 

Mr. KINGSTON. Thank you, Rosa. 

COMPLIANCE WITH CURRENT REGULATIONS

Mr. Levinson, in your testimony in terms of records requirements, you said that 59 percent did not maintain the contact information required by FDA. Then you talked about some of it was logistics problem, paper records versus electronic records, but 59 percent basically were out of compliance. So if all these were in compliance, playing by the rules, how much would that reduce the 

problem? 

The short of it is if we follow existing law, existing regulations, 

how much of this would be addressed and alleviated? 

Mr. LEVINSON. Mr. Kingston, it would be hard to know exactly 

how much of whatever risk might remain would necessarily be alleviated. One of the requirements is to keep contact information. And 

we thought it was important to reveal that to the extent that we 

have, out of 118, something like 60 percent or 59 percent of those 

who were asked, not being able to have the information, and then 

one out of four not even knowing that there was contact information that was required just reveals, in effect, a flaw in the regime 

that was set up by Congress a few years ago. 

As to whether if we had found that everybody had the contact 

information that that would resolve all safety-related issues, I 

guess that is something to look forward to another kind of study 

design. 

OTHER RECORDS

Mr. KINGSTON. Well, now, let us say they didn’t have the right 

FDA information or whatever but they did have some records of 

their own, maybe for product liability reasons or whatever. Did you 

ask them about that? 

Mr. LEVINSON. One of the interesting things that was revealed 

in the study is that actually some of the distributors, wholesale and 

storage facilities and retailers, actually had lot-specific information. 


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It wasn’t across the board everybody had a lack of information. 

There were actually some people who were not required to have lotspecific information who actually had it. 

Now, whether that was either out of safety issues or, perhaps 

more likely, for business-related reasons, I mean there really 

wasn’t a consistent pattern—— 

Mr. KINGSTON. I think if you were selling to Wal-Mart, they have 

a higher standard than, say, maybe the neighborhood grocer. I 

don’t know. But I think that would be relevant to your whole investigation, study. And I use the word ‘‘investigation’’ loosely. But if 

we are trying to reduce the number of traffic accidents and you 

have got people going 90 miles an hour because they don’t know 

the speed limit is 55, then we need to figure out how do we get you 

to comply with the existing law. Are you intentionally not complying or are you just totally ignorant, even though that is no excuse? 

But it would appear to me that would be part of our mission here 

is to get people in compliance with existing law so that we can get 

an adequate data sample. 

Mr. LEVINSON. Yes, absolutely. 

COMMINGLED AGRICULTURE PRODUCTS

Mr. KINGSTON. And also I wanted to ask Mr. Stenzel, fruit and 

vegetable really has been kind of ahead of many products, and it 

might be because it is easier. But I would imagine it gets pretty 

difficult when you get a blended product outside of the bulk commodity and it is mixed in with something. The reason why we 

know about that is because the definition of organic food gets to be 

very complicated when you start blending products together and 

chopping them up and so forth. What are you guys doing on that 

sort of product? 

Mr. STENZEL. I think you are right. I hope we are continuing to 

be out front on some of these issues. I think because we have fresh 

product that doesn’t have a kill step, it is eaten fresh and wholesome, we are very sensitive to maintaining that integrity all the 

way through to the consumer. 

For example, in a bag salad product today, or mixed vegetables, 

great, great care is taken to maintain records of the incoming 

sources. So if it has got a mix of lettuce and carrots in the same 

bag, that processor does keep lot identification records on where 

the carrots or the lettuce would have come from. 

Mr. KINGSTON. On FDA, on spinach, tomato, you mentioned 

about the collateral damage, it certainly is very important to ensure the safety of people first. But along the way, it does seem like 

you can be counterproductive if you say that all the peanut butter, 

all the tomatoes, are tainted; because the next scare comes along 

and people aren’t going to really believe you. So there is a danger 

of that. 

What are your recommendations to make FDA more effective, 

again using a rifle-shot approach rather than a shotgun blast? 

Mr. STENZEL. You are absolutely right, Mr. Kingston. I have 

called for in our industry for a total look at the way the FDA, the 

CDC, and State and local health departments cooperate in foodborne investigations. 


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Mr. KINGSTON. This might be the Chairman’s opportunity to underscore one agency. 

Mr. STENZEL. But that really is important. There is a diffusion 

of responsibility. There are different people going in different directions. And, really, we have seen in our industry in several of these 

outbreaks just how difficult it is to have—who is in charge. I have 

given the example of the National Transportation Safety Board; 

when there is an accident, that you know who is in charge. There 

is clear authority. The buck stops here. And we don’t have that in 

any food-borne investigations. 

MULTIPLE AGENCIES

Mr. KINGSTON. Madam Chair, I think this is my last question, 

but I want to make a statement. Following up on conversations you 

and I have had along the way, my concern about a single agency 

is that we will still have other agencies who won’t give up their 

control. And then if I am a producer—and what I don’t like is— 

you know, we need lots of small mom-and-pop producers. It doesn’t 

just need to be the domain of giants who can afford to comply with 

anything. 

What we want to do is make sure that for the mom-and-pops out 

there, you don’t have 15 agencies that can come and harass them. 

Work with them, but not harass them and not make production impossibly expensive and prohibitive. 

So I think talking amongst yourselves as food groups is very, 

very important in terms of recommendations to streamline this, 

and then also to take advantage of new technologies that really 

and truly were not out there 5 years ago. 

The Chair and I came here when e-mail was not used in congressional offices. And I remember on 9/11 there were very few BlackBerrys. And now absolutely everybody has them, from the new 

staffer onward. But technology is evolving so quickly now that it 

is like telecommunications. We pass a law today, it is obsolete by 

the time the agencies flesh in the bones of it. So we need to be 

careful on the emerging technology. 

Ms. DELAURO. Thank you, Mr. Kingston. And I think it is a 

point. And particularly with the mom-and-pop efforts, we now have 

15 agencies that deal in some way with a food safety responsibility, 

and I don’t know that there is anybody who has laid it out so that 

they don’t overlap with one another. 

Or talking about communication, which is what interoperability 

is about, it is about communication. If we think everybody is on the 

same wavelength and communicating, well, then we are just—I will 

show you a bridge you can buy maybe to nowhere. 

But in any case, you recognize a concern about what happens 

here, and that is about giving up turf, and that is a very, very difficult thing to do. But I think we are looking at a new environment, 

and I am not just talking about a new political environment with 

a new administration. And I think for me that is particularly helpful in this regard. But I think the new environment is what has 

happened in the various outbreaks of food-borne illness, and then 

culminating with nine people dying and industries potentially 

going out of business, that people are now beginning to say my 

gosh, maybe there is some relevance here for all of us. And your 


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input into all of this is really critical for us to try to move forward 

in some way. 

I have about three more questions or so, because I don’t want 

you to have to be here all day. 

This is about the Minnesota issue, because I think it is important 

in terms of what is in the public domain on that and what the findings are. During that investigation of salmonella in St. Paul last 

summer, there were a number of news stories about the process 

used in Minnesota to investigate food-borne illness outbreaks. Minnesota has seemed to pinpoint likely sources of contamination very 

quickly. 

In the salmonella case in particular, it appears that the State 

identified jalopeno as the cause before the FDA did. They were also 

able to suggest that the shipper was in McAllen, Texas, and that 

the peppers came from Mexico. 

In an AP story about the State’s work, a representative of the 

State Department, of Agriculture, who did the actual traceback was 

quoted as saying, and this is a quote, ‘‘A few phone calls and you 

can work it fairly quickly back to the grower.’’ 

This seems to be at odds with your findings, and it may have 

been fortuitous in that case that the outlet from which the people 

contracted their illnesses was a restaurant that was supplied by a 

large local distributor. 

So what I would like to have you do is for you to comment and 

for you gentlemen to comment as well. Minnesota and, you know, 

this comment about FDA. 

DIFFERENCES IN MINNESOTA EXPERIENCE

Mr. LEVINSON. Well, Madam Chair, I would certainly ask my colleague to comment as well. But my first reaction is how much I 

think the report has tried to be crafted in a way to give a snapshot 

of a system, you know, so that we look across a variety of suppliers, 

manufacturers, processors, and the types of food. I think that, 

anecdotally, I think once you drill down, you can find very important fact patterns like the one you are talking about in Minnesota 

that add either a level of complexity or a level of simplicity, sometimes, to what a solution might look like. 

And in a sense, I want to come back to your concern earlier 

about maybe the—what appears to be perhaps a weakness of the 

sixth recommendation; that FDA should conduct education outreach activities to inform the food industry about its records requirements. I do think that this is a terribly important area in 

which all of the key players—and the food industry is obviously a 

key player—and the FDA, I think, can hopefully craft an I&E effort 

that can really make a big difference in this. 

But let me turn the mike over to my colleague. 

Ms. NUDELMAN. I would just say that—I mean as we saw in our 

own study here, there is a lot of variability. And sometimes you can 

get back fairly quickly where there is one source to each piece. But 

I think what we try to do is make sure that you can trace that precise product back through each stage of the food supply chain. As 

many problems as you have back, you see a lot more problems 

going forward. 


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So as we saw in our study, facilities were a lot less likely to know 

their recipients, who they are sending the food to, and that you 

have seen the example of the peanut. Still right now, they are still 

identifying where that peanut paste went, who the recipients are, 

and that has, of course, a lot of impact on where to recall the product. 

So I think there are a couple of answers to that—why the difference of their findings versus our findings. 

Ms. DELAURO. Gentlemen? Tom. 

Mr. STENZEL. I would comment on Minnesota. Certainly there is 

a degree of expertise and commitment and funding there for those 

investigators that is much above the bar, on average. I would also 

suggest, however, that there is an approach that is designed for 

public health first. That is, go as quickly as you can to find the 

source. And they are working through any of these variabilities. 

They are making those phone calls. They are asking questions. It 

is a very engaging process. 

CRIMINAL LIABILITY-BASED INVESTIGATION

What we have found with FDA is it is a much more linear criminal liability-based investigation. They want the records. A number 

of our wholesalers and distributors through the summer were 

asked, send me all of your records of all the tomatoes you sold in 

the last 2 weeks. So, thousands of pages. Even companies who had 

electronic records were asked to print them out and fax them to the 

FDA. So we have a problem of a different intent, I believe, in the 

traceback. 

Ms. DELAURO. In a paperless society, they are drowning. 

Mr. STENZEL. There is a lot that needs to be fixed in this regard, 

but that is one explanation, I think, for why strictly on a health 

basis we can move a lot more quickly than on a records factual— 

criminal basis. 

Ms. DELAURO. And particularly if you have identified foods that 

are at high risk, then you really—Mr. Henry. 

Mr. HENRY. Yes. I think to echo part of what both of these gentlemen said, when you look at the State of Minnesota or other 

States, funding becomes a real issue. There are certain States out 

there that have almost a dearth of staff to take epidemiological reports on illnesses. 

And now you look at Minnesota where they do have a Department of Health and a Department of Agriculture. If they are all on 

the same page, which is more aligned, if you will, with a single 

type of agency, now you are getting conveyance of information very 

quickly to get to the issue, as opposed to the linear relationship 

that we see between CDC and FDA. 

CDC raises a red flag and says, hey, we think this is where it 

is; hence, the tomato issue. And I think that is where we need to 

have much more rapid transfer of information, not holding back, 

hopefully not worrying about litigation, et cetera, et cetera. Let us 

get to the source, let us get it off the shelf. 

Ms. DELAURO. Sam, do you want to go now? 

Mr. FARR. I will wait. 

Ms. DELAURO. Jack, you are okay? 


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Mr. KINGSTON. I might need to make a motion that you guys can 

continue without me if you want. 

Ms. DELAURO. Okay. That would be great. Thank you. 

Mr. KINGSTON. So moved. 

Ms. DELAURO. So moved. Okay. Thank you. The issue is that we 

need to have—— 

Mr. KINGSTON. We have a very conscientious Chair who does not 

want to appear to be doing it without equal—— 

Ms. DELAURO. I don’t want to do it without—— 

Mr. KINGSTON. She is actually a closet Fox fan, fair and balanced. It would kill her if that word got out. 

Ms. DELAURO. It is going to kill me now. 

NEW STATUTORY AUTHORITY

Let me ask a question that has to do with an FDA legislative 

proposal. As part of the food protection plan that was released in 

November 2007, the FDA asked Congress to give it 10 new statutory authorities related to food safety. I am not endorsing each part 

of the request, but they are to be commended, really, and I will say 

in what was a regulation-averse administration for making this 

kind of a proposal. 

ACCESS TO RECORDS

One of their proposals relates to access to records under the Bioterrorism Act, and there seem to be two parts of the proposal. Both 

relate to their activities in a food emergency. First is to allow the 

FDA to look at records about related articles of food, not just about 

the food in question. An example would be food produced on the 

same manufacturing line as the suspect food. 

Second, in an emergency, allow FDA access to records without 

having to show that it believes the food is adulterated. FDA says 

the recent melamine situation, which FDA had early clinical evidence that a specific food was causing illness in pets, but did not 

have clear evidence of a specific adulteration. That is the example 

for the scenario. FDA says that this would not impose any new 

burdens on industry, presumably, since these records are already 

required. This proposal is more limited than the OIG recommendation that FDA have access to records at any time. 

So I would love to have each of you to briefly comment on that. 

Mr. Levinson. 

Mr. LEVINSON. Madam Chair, I think that as you have explained, 

it would be a very helpful first step. But it would definitely be 

worth Congress’ exploring whether something more consistent, 

with a more comprehensive approach recommended by the OIG, 

might actually be more effective. 

Ms. DELAURO. Okay. Thank you. 

Mr. Henry. 

Mr. HENRY. Without question, if there is a regulatory mandate 

for records to be made accessible, as it is today in the Bioterrorism 

Act, or just to show that the lot coding is being managed by manufacturers, I think manufacturing entities would subscribe to that 

and will comply. That needs to happen. 

There is certainly a challenge when it comes down to having access to all records at all times for any reason. FDA is very typical, 


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and even as we speak today will come in not only asking for 

records but also photographs and other things that are really quite 

invasive and it takes more time to get that. It is not mandated by 

regulation if there is real advantage. 

And I think I would default back to Mr. Kingston’s line of thinking there. Is there additional value in getting that information that 

is going to help improve food-borne illnesses or, as you just made 

comment a moment ago, Madam Chairwoman, about drowning in 

paper, you know. Because how much time are you going to spend 

at a facility when you can’t deal with the paper that is already on 

your table at this particular moment? 

Ms. DELAURO. Mr. Stenzel. 

Mr. STENZEL. Both of those recommendations in the food protection plan we would support. 

Ms. DELAURO. Mr. Farr. 

Mr. FARR. Thank you, Madam Chair. I apologize for missing 

most of this hearing. I have been in other appropriations hearings. 

I really have a couple of questions. One is for United Fresh. 

PROGRESS ON MANDATORY REGULATIONS

I was really impressed by your asking for mandatory regulations, 

and I just wondered what progress has been made on that. 

Mr. STENZEL. Well, Mr. Farr, it has been a long time in coming. 

It is, as you know, a couple of years ago when our board of directors first made that call. I do believe that the FDA is much more 

intent now on moving forward with a regulatory standard particularly for those commodities when, based on science or risk, that 

they can say needs to have a specific standard set, the commodityspecific food safety standards. 

We have always said that they had the regulatory authority to 

do that without increased statutory authority, but they have been 

reluctant to this point in time. Certainly Congress is now also considering a number of bills that would be very straight and plain in 

providing that statutory authority, if there is any question. And I 

would anticipate that that is going to move forward rather expeditiously. 

Mr. FARR. As you know, the industry is really complicated in the 

sense of how many—from the field and the place in the field and 

where that field may be located geophysically to surroundings to— 

I have been very impressed in the Seines Valley how they are now 

mapping those fields, and can tell you with every box what—almost 

the exact spot of the field that that came out of. And those boxes 

are shipped all over the country. 

SMALL, ORGANIC GROWERS

And, you know, you question what might happen in the transportation process or the unloading or putting the vegetables on the 

shelves. And I just hope that we don’t create—because the backlash—I was on a talk show last weekend for small organic growers, 

and they are fearing that this whole thing is going to disrupt ability for them to grow in their garden and take it down and sell at 

the farmers market. 


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Mr. STENZEL. I think that is a valid point. We have got to be very 

careful that whatever regulatory requirements are put forward are 

not inhibitive or punitive to smaller growers or organic growers. 

At the same time, food safety is not a scalable thing. You can’t 

have E. coli in your food, no matter how small a farm you may 

have. So we have got to be consistent in that regard. That is where 

I do think FDA has got to use proper judgment, consultation with 

the U.S. Department of Agriculture, consultation with the State 

Departments of Agriculture and Industry. 

In your own district, the California Leafy Greens Marketing 

Agreement has done a fantastic job at setting forth the standards 

that all of the growers should be complying with, and those are the 

standards that I think are appropriate for that sector of our industry across the board, no matter where that product is grown. 

Mr. FARR. Do you think, as we develop the concept of regulations 

in these areas, that we are consistent with what industry thinks 

is practical and can be done? 

Mr. STENZEL. For the most part I do. That is always the risk you 

run when you ask for regulation: Is it going to be wise regulation? 

Hopefully, we are not asking for something that doesn’t make 

sense. But there is going to be oversight required of the FDA to 

make sure that they don’t go too far in some of those areas; that 

they do recognize the difference in growing regions and what is 

necessary for safety and what might not be. 

GOOD AGRICULTURAL PRACTICES

Thus far, I believe the guidance documents, the FDA revision of 

the Good Agricultural Practices that is coming, they are on target 

with what I think is the most responsible approach to growing 

fruits and vegetables. 

Mr. FARR. I want to compliment you as a representative of your 

industry, because whenever we have had these crises in the past, 

I have never seen an industry step up and say we are ready to be 

supportive of regulation. And I think you are really to be commended for that in being a part of it. 

Madam Chair, if I can, I have one more question and that will 

be it. And it is of the IG. You are the IG? 

Mr. LEVINSON. Yes. 

Mr. FARR. Sorry. I don’t have my IG I.D. 

Related to this recall—and I have gotten very interested in this 

issue. I never even knew. It was a little something that I saw with 

the E. coli recall, and then with the fires we had in Big Sur last 

year, and it is called crisis communication, and it is a whole developed field. I mean, medicine has always had it, and we remember 

the old adage to doctors: Don’t alarm your patient. But we don’t 

seem to be using that—and law enforcement is beginning to learn 

about it. 

COMMUNICATION PROTOCOL FOR RECALLS

Did you look into communication, how professional or what they 

are doing to develop smart protocols for recalls? 

Mr. LEVINSON. Well, in all candor, Mr. Farr, that is really beyond 

the study that we undertook here that is the focus of the hearing 

today. We have conducted several reviews of FDA work. And I 


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think the question that you are asking would really be of a more 

generalized nature than our specific work in OIG. But we have certainly identified FDA as—there is a major management challenge 

for FDA and the enormous jurisdiction that it has and the ability 

to align its work in a way that is effective and brings a high degree 

of confidence from the American people, from Congress. And I 

think that is reflected to a certain degree in our expression of concern over just the management challenge that FDA faces. 

On the more law enforcement-specific ideas, we have looked 

closely at their own internal investigations process and have expressed concerns about how that works. And I think that kind of 

work should be—I would hope would be an important trigger in 

FDA revisiting or rethinking the way it handles things like recall. 

Mr. FARR. Maybe you could help me understand. I sit on Homeland Security, which you would think would be the kind of area 

that would have that, but they don’t have jurisdiction in this area, 

and they are just beginning to understand even questioning issues 

of food-borne biology that could lead to intentional food contamination or terrorist-type acts. 

It seems to me that this is one of those areas that is emerging, 

particularly with the technology you have. We heard in the Virginia Tech shootings that the responders didn’t have the information that the students in the classroom had, and they were text 

messaging on Facebook, and who was looking at that was the 

media. So here were the responders going through their responding 

channels that weren’t accurate. 

And so what happens is you arrive at a scene or you have an incident developing, and it is depending on how you handle that. You 

can take a problem and escalate it into a crisis because you haven’t 

got the right people to respond to the crisis or you are not saying 

the right things and can develop a panic. 

And it seems to me that all of us in government, because we are 

the authority, we have got to start figuring out how in a new Information Age that we are going to handle emergency communications—and I would imagine that all recalls are emergency communications or warnings—that we have got to do a much more—be 

much more sophisticated than we have traditionally been in just 

sort of leaving it up to the law enforcement speak, the police channels, and it includes regulatory agencies like the FDA. And if you 

have any idea, I don’t even know how to start questioning all that. 

Mr. LEVINSON. Well, I think you have outlined a lot of the most 

important concerns that should really be at the forefront as policymakers rethink, and especially Congress, rethinks, how it might 

want to align functions that historically have been buried in different departments or agencies. And of course, ultimately, it is the 

Congress’ responsibility, authority to structure or restructure executive agencies and departments as it sees fit. 

And I would certainly agree with you that historically this has 

not been viewed in a more wholistic way; and at this point, and especially given the progress we have with information technology, 

deserves a real revisit by people across a much wider spectrum of 

the national security picture than we have perhaps experienced before. 


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We have a piece of that at HHS and specifically at FDA, and I 

would hope that this is the kind of study that serves as a good example of the kinds of concerns that may be elevated to the Congress and to the Executive so that we can rethink how this actually 

works in practice. 

Mr. FARR. It gives me something to think about. Thank you. 

Ms. DELAURO. I just have two more questions. 

ONGOING WORK WITH FDA FOOD ISSUES

Mr. Levinson, I am curious about your ongoing work with the 

FDA food issues. You indicated that you are conducting a number 

of audits, registration of food facilities with the FDA, FDA’s inspection of food facilities and its follow-up on violations, and several audits on FDA’s authority and procedures for recalls. Can you give us 

some additional detail on each of these reviews? Are there any preliminary findings that you can share with us? 

I would just also add for fiscal year 2010, there is a bill moving 

forward, and we will see legislation—there is a major authorization 

in the Energy and Commerce Committee on the food safety issue. 

So I think your reports could be very very helpful in this regard, 

and if you can tell us when you expect to complete them. So any 

details, preliminary findings, when do you expect them to be completed? 

Mr. LEVINSON. Thank you, Madam Chair. And really on behalf 

of an outstanding Office of Evaluations and Inspections and Audit 

Services as well, we do have within very limited kinds of resources, 

I might add, a fairly robust current and ongoing work in food safety. As you mentioned, compliance with FDA’s food registry requirements, which we expect to be completed this fall; FDA’s inspections 

of domestic food facilities, which we have a projected a completion 

date of 2010; imported foods, with a completion date sometime during this fiscal year; imported pet food and feed products, again to 

be completed toward the end of this fiscal year; human food and 

pet food recall procedures with a projected completion date of 2010. 

We also have work on FDA’s consumer complaint system process, 

medical devices, clinical trials and human subject protection due 

next year. 

So this is a robust agenda. And without being able to provide 

really specific status of work at this hearing, I would certainly welcome the chance for our staff to be in regular contact with your 

staff so that you are kept very much current with where we are 

headed with this work. 

Ms. DELAURO. I appreciate that and would like to keep in touch. 

I would also like to suggest, and I will make the suggestion, that 

Congressman Waxman’s committee have the benefit of some of this 

information as well, and to loop their staff in. 

So as we move forward, let us move forward with good, solid information, and not then have to backtrack because we didn’t know 

about something or we thought we had looked at it but that we 

haven’t. This is a question of the interoperability of our communication. And so I just think we are in an era, in a moment, when 

there is a spotlight on all of this, and I think we need to take advantage of that to its best results for the future. 


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SHARING RESPONSIBILITY FOR TRACEABILITY

Mr. Henry, let me just ask you a quick question, because in your 

testimony you said you call for the sharing of responsibility for 

traceability through office supply chain. Let me just ask you plainly, who is not carrying the load, the burden here? 

Mr. HENRY. What we are really referring to there, as you look 

at the scope of the BT Act and who is required to participate, 

which is all those things that I think Mr. Levinson has already 

pointed out. So if there is a gap and the gap needs to be filled, then 

action has to be taken appropriately. 

Ms. DELAURO. I just want to make this one comment. I wish Mr. 

Kingston was still here because I think it was Mr. Kingston who 

talked about the mandatory recall earlier on, and this is an article 

from today. 

[The information follows:] 


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Ms. DELAURO. This is in the New York Times by Gardiner Harris. It is about this report. It says: ‘‘Investigators find source of 

many foods untraceable.’’ That was the Gardiner Harris piece. 

PEANUT CORPORATION RECALL

But this was very interesting to me. This was about the Peanut 

Corporation of America and the salmonella issue. It says, ‘‘As late 

as Monday, the Food and Drug Administration formally asked 

Westco Fruit and Nuts, Inc., based in Irvington, New Jersey, to recall all of its products containing peanuts made by the Peanut Corporation.’’ 

Now, I am surmising that the FDA was basing that on some reality here—you know, I have to—but how this thing is still ongoing. 

‘‘Jacob Moradi, Westco’s owner, could not be reached for comment, but he told ABC News that the FDA’s recommended recall— 

the agency does not have the power to issue food recalls on its 

own—could ruin his company. ‘They are asking me to commit suicide based on presumption,’ Mr. Moradi said in a broadcast issue. 

‘They have shown no proof.’ An official said Mr. Moradi hid from 

investigators at his plant.’’ 

Now, I mention this because there are two pieces. I understand 

that Mr. Moradi is afraid that he is going to go out of business. 

But, again, we have to have a process at FDA which allows it to 

make a decision based on solid information that there is a problem 

here and therefore can say, you are shut down. You are shut down. 

But based on proof and data and science. 

So we now are in the position where it is so tenuous that there 

is the view of oh, maybe they don’t have any indication or proof or 

science. And on the other hand, my God, what is the product that 

these folks are dealing with that my family may have consumed 

and they won’t recall their products? There is no—this is a no-win 

situation. A no-win situation because, in fact, it would appear that 

there is no one in charge here of making a determination. 

Our goal here is not about—I mean this has been a terrific hearing. This is a complicated issue of traceability, and we need to do 

it. We need to do it right. We need to know where the first part 

is and where does it start and where does it end and how can we 

put in place a mechanism? 

I think it is doable. I think you think it is doable. We are not 

in the 1930s here. There is technology. There are all kinds of ways 

for us to address this and deal with risk, deal with technology and 

inspection based on risk. But it is data that pushes us in that direction, so we can grant assurances on public health and assurances to a company that you are not going to go out of business 

here. 

Mr. FARR. Madam Chair, if I can, my experience in that is when 

the government actually orders destruction of farm animals, the 

government will pay for it; so it is a takings issue. And I think a 

lot of this sort of gets into this tort liability issue of if we are not— 

like in the spinach, we didn’t take it. We voluntarily asked people 

to take it off the shelves. And for that—and they did. They responded immediately. 


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VOLUNTARY RECALL AND REIMBURSEMENT

Many thought, well, I will get reimbursed for these costs. And as 

you know they didn’t, and the insurance company said that was a 

voluntary recall. We don’t ensure that. So you are in this gray 

area. And I think if we are going to resolve this question, it has 

really got to be the one of who is going to pay for it. 

We have some of these protections under the Perishable Commodities Act, where if a buyer doesn’t—if you buy wheat and you 

don’t sell it in time, it is still good the next week. If you buy strawberries and you refuse to pay on them, they rot, and there is no 

secondary market. 

So a lot of this is how you figure out the way to pay for it. Or 

if it is negligence, then the government shouldn’t pay for it; the entity ought to be charged. 

Ms. DELAURO. Well, I think that is a point and that is making 

the determination. 

It is alleged that I am not going to deal with litigation, but we 

may be in a position with a company that knowingly sold a tainted 

product. Knowingly sold a tainted product. And we have to have 

the capability of making that determination, which means a number of enforcement tools and a number of strategies, enforcement 

strategies, that get at what happened. 

Once you begin to put some pieces in place, people are not foolish; they say, why would I put myself in this position? But if we 

continue to just self-regulate and just turn a blind eye, well, then, 

hey, whatever the market will bear, and I am going to presume I 

am not going to get caught and I can just move on. 

Not to be litigious, but we have got to have the full spectrum of 

tools available to be able to address what the current set of concerns are. 

Thank you all very, very much. Obviously we look forward and 

we hope you will view that there is an open dialogue here about 

how we can try to move forward. I don’t want to wait months. I 

think we need to move quickly and try to see how we can try to 

make some very strong recommendations about how traceability 

can work and what it could look like. So thank you all very very 

much. 

This hearing is adjourned. 


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THURSDAY, MAY 21, 2009. 

FOOD AND DRUG ADMINISTRATION 

WITNESSES 

JOSHUA M. SHARFSTEIN, M.D., PRINCIPAL DEPUTY COMMISSIONER 

AND ACTING COMMISSIONER, FOOD AND DRUG ADMINISTRATION 

PATRICK McGAREY, DIRECTOR OF THE OFFICE OF BUDGET FORMULATION AND PRESENTATION 

NORRIS COCHRAN, DEPUTY ASSISTANT SECRETARY FOR BUDGET, 

HEALTH AND HUMAN SERVICES 

Ms. DELAURO. The hearing is called to order. Good morning. Let 

me welcome everyone this morning, particularly Dr. Joshua 

Sharfstein, who is the Principal Deputy Commissioner, Acting 

Commissioner of the Food and Drug Commission. I am pleased 

again to welcome all my colleagues. Our ranking member will be 

here shortly. Mr. Latham will make opening remarks in a moment. 

And I’m happy to continue with our efforts to move on with the 

budget hearings for the 2010 Agricultural Appropriations bill. 

Dr. Sharfstein, let us just all welcome you here and congratulate 

you on your new position. Delighted to see you, so much look forward to collaborating with you and Commissioner Hamburg in the 

months and the years ahead. I had the opportunity to meet with 

and talk with Dr. Hamburg yesterday, and I’m looking forward to 

a—our conversation yesterday was just open and positive and productive, so, looking forward to that relationship. 

I know that you agree that FDA’s first responsibility is to the 

American people, to ensure the safety of food they eat, the drugs 

that they take and the medical devices that they rely on. That is 

the agency’s most fundamental regulatory mission. The American 

people must be able to depend on the system, and the people in 

charge of protecting them. 

I’m proud that since taking the chair of this subcommittee, we 

have begun to address that critical need for more resources. This 

committee and Congress have increased the FDA’s total budget by 

more than $572 million since 2006. In 2009, FDA has 39 percent 

more in discretionary resources than it had in 2006, $572 million, 

despite overall spending limitations imposed by the previous administration. On top of that, a supplemental appropriation in 2008 

of $150 million. I’m proud that since September 2008, the agency 

has been able to hire 1,500 new employees, scientists, inspectors, 

analysts who are doing critical work, a direct result of those increased resources. 

Looking ahead to 2010, I am encouraged by the Administration’s 

$2.3 billion request for discretionary resources provided by this 

committee, an increase of $299 million, almost 15 percent over last 

year. I believe this is a good start at giving FDA what it needs to 

get back on track. It represents a strong commitment to building 


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the historic levels of investment this committee has made over the 

last three years. 

Dr. Sharfstein, I know you’ve already begun working to connect 

the recent increases in resources to concrete positive public health 

outcomes, and I encourage you to continue to make them a priority. 

But as you know, the problems at the FDA will not be solved simply with more funds and with stopgap measures. As you know, you 

are coming into an agency that is desperate, in my view, for fundamental reform. When we look at recent headlines, unsafe foods, 

dangerous medical products slipping through the cracks time and 

again, it is hard not to see a system in crisis and an FDA hobbled 

by a fragmented structure with outdated legal authorities in many 

areas and insufficient authority to protect the American people. 

To restore the agency’s gold standard mission and ensure the 

fundamental safety of the food and drugs that it regulates, I believe we must be guided by four principles: First we must increase 

funding to support the FDA’s mission. Second, we must improve 

the management of the agency and hold it accountable. Third, we 

must push back against the influence of industries over the agency. 

And finally, and perhaps most importantly, we must let scientists 

do their work guided by science and not by political or ideological 

interference. These are the guideposts I will use in judging our 

progress as we move forward in a new Administration. This is our 

opportunity to get the big things right for the American people to 

make real changes that will affect their health and their safety 

every day. 

With that in mind, let me raise a few issues that I imagine you 

will discuss in your statement, and I may ask you to elaborate on 

when we get to questions. In particular, I commend your decision 

to exclude from the budget fees from industry to finance the agency’s direct to consumer television ads. I have always been of the 

view that having drug companies pay for the review of such ads 

and having reviewers’ salaries dependent on drug company fees 

will further undermine the public’s confidence in the FDA. 

By the same token, I would like to hear more about your proposal to increase the number of generic drugs in the market and 

how you view the role of generic drug makers in this expansion. 

I also know the FDA must frequently confront new and growing 

demands in a constantly-evolving public health environment. As 

you know, the House recently passed very important legislation 

giving the FDA responsibility for tobacco regulation. And the Senate is marking up their version as we speak. I look forward to 

hearing your strategy for implementing this regulation and discussing how you envision that responsibility fitting within the 

agency’s overall public health and safety mission. 

In the same spirit, I also know you will update us on FDA’s approval of a new plant to make seasonal influenza shots that could 

also be used to make an H1N1 vaccine. Indeed, since the virus’s 

outbreak, much of our public health infrastructure, including the 

FDA, has been put to the test. I want to commend you and all of 

the outstanding scientists and doctors for their quick and their 

thoughtful response. And I’m curious to learn what we are learning 

from this experience, what new demands has this outbreak created, 


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and how will our response going forward affect the agency’s larger 

mission. 

I thank you for joining us this morning, Dr. Sharfstein. I look 

forward to asking you about these and other efforts within the 

FDA. As I told Secretary Vilsack last week, our appropriations reflect the priorities of this great nation. We have big goals, and it 

is the details, the budget and the basics that we are discussing 

here today that get us to be able to reach those goals. 

With that, let me recognize my colleague, Mr. Kingston, for any 

opening remarks that he may have. 

Mr. KINGSTON. Thank you, Madam Chair, and I’m going to yield 

to Mr. Latham. 

Ms. DELAURO. Okay. Thank you. 

Mr. LATHAM. Thank you, Jack. Thank you, Madam Chair, and 

welcome, Dr. Sharfstein. The FDA is one of the most important 

agencies that this subcommittee has jurisdiction over, and as you 

can probably imagine, we’ve had a lot of people advocating for increased funding on your behalf, not just the agency itself. 

I’m not aware of any other government agency probably outside 

of the CIA today that catches more grief from politicians and industry and others, and for as long as I’ve been in Congress, we’ve 

heard the same drumbeat about the agency being underfunded and 

understaffed. That said, there is much being asked of the FDA, and 

I would argue that as we try to achieve a risk-free society, we expect almost the impossible from your agency. So I think there 

needs to be some recognition that the FDA has challenges, but 

there is good work being done at the agency, and the folks on the 

ground really don’t get the kudos that they deserve, and I think 

this committee would back that up. 

The Administration or you’re asking for a 19 percent increase in 

funding, and once again, much of that is based on the expectation 

of new user fees that Congress supposedly is going to create. I don’t 

know what the prognosis for that is, and it’s usually very difficult. 

So for today I hope we can have a productive conversation about 

these numbers, your priorities, and that we can draft a responsible 

spending bill that ensures that you can effectively do your job. So, 

with that, Madam Chairman, thank you. 

Ms. DELAURO. Thank you. Mr. Kingston, would you like to make 

any remarks? Okay. Thank you. 

Dr. Sharfstein, if you would please, we’ll move to your testimony, 

and you can be assured that the full testimony will be made part 

of the record, so you’re free to summarize as you like. 

INTRODUCTORY REMARKS

Dr. SHARFSTEIN. Great. Thank you very much. Thank you Chairwoman DeLauro, Ranking Member Kingston, Congressman 

Latham, other members of the subcommittee. I am Dr. Joshua 

Sharfstein, the Principal Deputy Commission and Acting Commissioner, but not for very long, of the U.S. Food and Drug Administration. 

I am pleased to present the President’s 2010 budget request for 

FDA. For today’s hearing, I’m joined by Patrick McGarey, the 

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tation, and Norris Cochran, the Deputy Assistant Secretary for 

Budget at HHS. 

In my testimony today, I will outline the Fiscal Year 2010 budget 

request and the policy initiatives that we are advancing in our 

budget. I will also summarize recent developments related to the 

2009 H1N1 flu virus outbreak and describe how FDA is responding. 

Let me start by thanking the subcommittee for exactly what you 

laid out, Chairwoman DeLauro, the historic investments at FDA 

that have been made over the last few years. I think these investments demonstrate the strong support of the subcommittee for the 

public health mission of FDA and the health of the American people. 

When I came to FDA a few weeks ago, I asked each center to 

provide examples of how they’re using these funding increases to 

promote public health in the United States. I believe a key goal of 

management for the FDA is to be able to connect the investment 

that you’re making and the American people are making in the 

agency with clear public health outcomes. And I got some very interesting responses. 

PUBLIC HEALTH OUTCOMES

I heard from the Center for Biologics that because of your investment, FDA is moving forward to be able to test the blood supply, 

and have the blood supply tested for rare and emerging strains of 

HIV. That we are now able to have trained many device regulators 

around the world so that the devices that we get are safer. 

We are developing a Hepatitis A test for foods that had never existed before, so you could actually test a food to see if the Hepatitis 

A virus is there. We are developing rapid food safety diagnostics so 

we don’t have to wait days for the results of salmonella tests. We’re 

developing a system of coordinating with veterinarians so that pet 

food outbreaks can be identified quickly and stopped. And there’s 

very interesting research going on that will lead to new ways in 

evaluating pediatric anesthesia, which is important for children 

and important to me as a pediatrician. 

And of course there’s flu. I think it’s really important for you to 

recognize the investments that you made in FDA over the last couple of years are directly related to the nation’s preparedness for flu. 

And the best example of that is right now we have six different 

companies essentially making flu vaccine for the U.S. market. In 

2004, we were down to two, and it was only because of additional 

resources that FDA switched its model to proactively reach out to 

companies to try to engage them in the U.S. market, went out and 

inspected them and worked with them to develop their products for 

the U.S. market, and in the most extreme example, work with a 

factory that was just getting built and were able—which leading to 

the approval a couple of weeks ago what will lead to the doubling 

and eventually the tripling of the domestic manufacturing capacity 

for the injectable flu vaccine. And all that was really possible because of the investments that have been made over the last few 

years. 


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BUDGET REQUEST

So let me take it back up to the whole budget. The request overall includes $3.2 billion to protect and promote the public health 

through FDA’s mission. This includes an increase of $510 million 

for FDA programs, which is a 19 percent increase compared to last 

year. This historic increase demonstrates this Administration’s 

commitment to food safety, medical product safety and the health 

of the American public. 

The increase includes $295 million in budget authority and $215 

million in user fees. And this budget organizes these into two initiatives: Protecting the food supply and safer medical products. It 

also includes $74 million for statutory increases in user fees and 

for infrastructure to support FDA’s mission. And I certainly would 

encourage everybody here to visit the White Oak campus if you 

haven’t already. It’s really remarkable and also demonstrates a tremendous commitment to the agency and public health. 

This budget recommends four new user fees to facilitate the review of generic drugs, enhance FDA’s ability to register and inspect 

food and feed manufacturing and processing facilities, allow FDA 

to reinspect facilities that fail to meet good manufacturing practices and other safety requirements, and allow FDA to collect fees 

when it issues export certifications for food and feed. 

It also recommends new authority for FDA to approve generic— 

I would say follow on biologics through a regulatory pathway that 

protects patient safety and promotes innovation. 

Finally, the budget also includes $5 million for FDA to develop 

policies to allow Americans to buy medications that are approved 

in other countries. 

PROTECTING AMERICA’S FOOD SUPPLY

Let me go into a couple of details. First, I would like to talk 

about protecting America’s food supply. For Fiscal Year 2010, FDA 

proposes an increase of $259 million for food safety activities. This 

includes $164.8 million in budget authority and $94.4 million in 

three new user fees that I described before. 

This funding will allow the agency to hire over 600 additional 

staff to work on food safety. It will pay for cost of living increases. 

It will, through the staff, fund significant increases in domestic and 

foreign risk-based inspections, audits and laboratory analyses. The 

number of staff includes more than 220 additional investigators to 

conduct inspections, and we anticipate that when fully trained and 

deployed, this will lead to significant increases in the number of domestic and foreign food safety inspections. 

More importantly in my mind than inspections, this will also 

fund an increase in—it will also fund FDA’s ability to implement 

a strategic framework for an integrated national food safety system. And this includes working very closely with states and localities to integrate our efforts and develop preventive-based regulations and guidances that will shift our food safety system from 

what I think is now fundamentally an outbreak-focused food safety 

system to what should be fundamentally a prevention-focused food 

safety system. 


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These resources include money for the states, money to develop 

capacity around prevention, money for regulations. In addition, 

there’s funding to better respond to outbreaks, which includes detecting contamination, quickly tracing contamination, and communicating risk during a food safety event. This funding will also support three new laboratories for chemical analysis. 

And there’s a major investment in information technology systems, including systems we use to screen, sample, detain and take 

enforcement actions against imported food and feed products that 

violate FDA safety standards. 

SAFE MEDICAL PRODUCTS

As far as safe medical products, the budget proposes $166 million for medical product safety. This includes $120 million in budget authority and $46.6 million for a generic user fee program, and reinspection user fees related to medical product facilities. What this 

funding would accomplish is about more than 300 additional fulltime equivalent staff. It would also fund the cost of living adjustment, and it would permit additional inspections of both domestic 

and foreign sources of ingredients, components and finished products throughout the drug and biologic and device supply chains. 

Within the Center for Biologics, it would allow the hiring of additional safety experts for blood, tissue and vaccine safety teams, and 

would allow CBER to develop new screening tests for emerging 

blood-borne diseases, and additional work on identifying safety signals for both vaccines and tissue products. 

For devices, it would allow the Center for Devices to implement 

safety requirements including in the FDA Amendments Act. This 

would include analyzing data relating to children’s devices, conducting a medical trials workshop to address unmet pediatric device needs and hiring additional experts. There is also a special 

focus on eye medical devices that are included in the budget. 

For CDER, the drug center, the budget increase would allow 

more work to be done on how to best use the risk evaluation and 

mitigation strategies to minimize drug risks and promote safe drug 

use. It also would allow CDER to conduct research on bioequivalent 

standards for generic forms of products such as metered dose inhalers, topical drugs and complex dosage forms, such as lipozone products. It will also expand enforcement against Internet sites that expose consumers to unapproved products and fraud. 

For the Center for Veterinary Medicine, the funding will allow 

risk evaluation of animal biotech products and also expand efforts 

to create a safety system for animal drugs, and it will support research at NCTR on nanoscan materials and other important products. And there’s a significant IT investment there. 

LEGISLATIVE INITIATIVES

I should just briefly mention that there are legislative initiatives 

that are implied by the budget. These include support for generic 

drugs by developing a user fee program that would facilitate reduction of the backlog in generic drug applications. It also presumes 

a passage of legislation to permit follow-on biologics with a workable and scientifically sound regulatory pathway that could significantly reduce costs to the American people. 


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FLU OUTBREAK

Let me just briefly mention, if it’s okay, how FDA has responded 

to the flu situation, because I think it really demonstrates how 

FDA is a public health agency working for the American people. 

Now this all happened really just a couple of weeks into my time 

at the agency, and I was really just getting acquainted. And I was 

just extremely impressed by how the agency responded, and I want 

to explain what happened. 

As soon as we became aware of the outbreak, I asked Dr. Jesse 

Goodman, who is here today, the Acting Chief Scientist and Deputy 

Commissioner for Scientific and Medical Programs, to coordinate 

and lead FDA’s efforts. And he oversaw a management structure 

that was different from the day-to-day management structure that 

FDA used. We established an incident command structure. We created teams around different topics, and they reported to Dr. Goodman. The substantive teams we created included the vaccine team, 

the anti-viral team, the in vitro diagnostics team, the personal protection team, the blood team, the shortage team and the consumer 

protection team. We also had other elements of incident command 

which include logistics support and communications, legal and 

worker safety. 

So we actually shifted to a 24-hour move, because the CDC was 

interested in deploying products from the stockpile, and to do so, 

they needed some emergency approvals for things that were not approved by the FDA to that point. The team worked over the weekend, and at three in the morning, I signed several emergency use 

authorizations, which included the first dosing for Tamiflu for children under age one that CEDR came up with after extensive work 

over the weekend, and that was based on the tremendous amount 

of work they had done to that point on kids under age one. It also 

included approval for Relenza to be distributed by public health authorities, and it included the first diagnostic test for H1N1 which 

permitted CDC to distribute that test across the country and to 

more than a hundred countries around the world. 

This team, this incident management team, has been meeting 

since then and has not slowed down even as the particular epidemic has taken its twists and turns. And I was just reading the 

most recent report from the team. And just to give you a sense of 

what’s going on, the anti-viral team is aggressively looking at—and 

to take a step back, obviously the epidemic is not as virulent as initially feared at this point, but there is a lot of concern that when 

the fall flu season hits, it could come back and be quite significant, 

and certainly in this respect, when you’re dealing a previously unseen flu virus, given the course of events in the 20th Century, it 

is definitely better to be safe than sorry. And so we have been 

working very aggressively to think about how we prepare for the 

worst case scenario even if we never need to use those preparations. 

One of the things that CEDR is doing—sorry, the anti-viral team 

is doing is reaching out to manufacturers that have experimental 

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proved to see what might be made available if we really run into 

a problem this fall. 

The shortage team is already contacting manufacturers of basic 

antibiotics, IV fluids and antivirals to make sure that they’re increasing their supply in case of a big problem this fall. 

The vaccine team is working full steam ahead on the preparations for a vaccine, and that includes growing the virus in the 

FDA’s labs. There are sheep that have to produce antibodies to test 

the potency of the vaccine. The FDA is a pivotal player in approving and helping design the clinical studies that will be used for the 

vaccine when one is produced, and working with the manufacturers. 

There’s a blood team that’s working in basically the supply of 

blood, which has been fine throughout this, and monitoring any 

questions of risk to the blood supply from the flu, of which there 

have not been any serious questions raised so far. 

The diagnostic team is working very closely with CDC on the development of more additional rapid diagnostic tools for this particular virus. 

And the consumer protection team is quite active now looking on 

the web to identify people who are really trying to defraud the 

American public. And I’ll just read one website that recently got a 

warning letter and is shutting down from FDA. It said, ‘‘Independent tests show this product is hundreds of times more effective 

at killing the flu virus than the most potent antiviral prescription 

medications known, and it’s the only one that actually kills the 

virus within a few hours and automatically eliminates all symptoms.’’ 

So FDA I think has taken several dozen enforcement actions 

through its consumer protection team to make sure that people are 

not misled. But my concern as a physician is that people would 

turn to products that clearly don’t work instead of seeking medical 

attention, which is incredibly important when they’re sick from the 

flu. 

So I think I’ll stop there. There’s a lot more detail in the written 

testimony, and I look forward to your questions. 

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Ms. DELAURO. Thank you for your testimony. Let me start with 

really a general question of many specific ones. As I outlined in my 

opening statement, I do believe that the agency is badly broken, 

and I think there are a number of surveys of employees who have 

found low morale, reflecting the efforts to muzzle staff, et cetera. 

I don’t have to reiterate all of that. And you also commented and 

we have with regard to resources, and I am confident—I don’t suspect—I’m confident we will make additional gains in terms of resources in 2010. 

But what I would like to hear from you is about the other three 

areas: Management, industry influence and science. And what I’d 

like to know is how do—because these are the measures that we 

will return to in the future as to how we are really addressing 

these areas. If you can, tell us how you are approaching looking to 

improve the management of the agency, addressing the undue influence of the industry, and ensuring that the decisions are based 

on science. 

FDA MANAGEMENT

Dr. SHARFSTEIN. Thank you. I think you’re absolutely right that 

funding is just one part of the picture at FDA. And I think that 

management is extremely important. I’m very much looking forward to Dr. Hamburg. Both of our backgrounds are in running 

large public health organizations. Hers was much larger than 

mine. I was the health commissioner in Baltimore City. She was 

the health commissioner in New York City. But I think there are 

a lot of principles that are important from that experience that I 

think we both hope to bring to this. 

It is very important that in every unit of an organization that 

people feel accountable for what they’re doing and not just, you 

know, the kind of checking the box, of having kind of run through 

the motions of something, but actually moving a project forward 

that is clearly linked to public health. That’s really what I think 

our management goals are going to be. 

I think—and when I started by asking the different centers 

where did the increases go that really are directed to projects that 

are going to lead to improve public health, that was a message that 

we were able to send, and I think people have responded very well 

to that across the agency, that we really expect to be able to be accountable for where the resources are going and what the impact 

is going to be. And I think as we move forward and Dr. Hamburg 

starts, we have a few ideas for her to consider, specifically in how 

to move that forward. 

But I think you’ll see some specific mechanisms put into place in 

the management of the agency that will allow that to happen and 

will provide I think you and the subcommittee a lot more understanding of how the resources are used, and a lot more confidence 

in the management of the agency. 

INDUSTRY INFLUENCE

To your second point on the influence of industry, I think that 

the credibility of FDA is absolutely critical, and I think one of the 

most challenging things externally and internally for people who 

worked at the agency were hits to the agency’s credibility over the 


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last several years. And I think Dr. Hamburg and I plan to make 

that a major focus. And the question of industry influence is one 

element of that, but I think there are other elements, and I think 

the FDA’s being more transparent about how it’s making decisions 

and why it will be very important to addressing that. 

SCIENTISTS

To your third point, letting the scientists do their work, I have 

been extremely impressed by the talent that’s at FDA. I go to meeting after meeting where, you know, I kind of feel like I’m an imposter because around the room are twelve scientists through their 

careers are on a particular issue of the topic. And you really have 

to respect the kind of brainpower that exists at FDA. 

And I think I’ve been very impressed by how positively people at 

FDA have responded to really how I open most meetings, which is, 

you know, I’m interested in hearing what you think should be done 

to move these issues forward, whatever the topic is. And I think 

it may be that one way to approach the fact that FDA has limited 

authority is to say, well, if we don’t have authority there, then no 

reason for us to think about it. 

But I’m really encouraging, and I think our approach is going to 

be that let’s start with what the right thing to do is. If we can do 

it right away, then let’s try to do it, because that’s going to help 

American consumers, and I think along with consumers when people have confidence, it’s going to help the industry, too. But if we 

don’t have the authority, then we’re going to talk about what we 

need to be able to protect the public. So I think that message has 

really resonated, and I think that’s the start, and we’ll have time 

to talk about maybe other elements of this. I think that’s one part 

of changing the approach to science at the agency. 

Ms. DELAURO. My time has expired, and I want to try to hold 

us to the five minutes so we can get as many questions as we can, 

but I thank you for that. Mr. Kingston. 

Mr. KINGSTON. Dr. Sharfstein, let me ask you a couple of questions. I’m very concerned about the national debt, $11 trillion right 

now. And it seems to be something that we as a nation have chosen 

to kind of put on the back burner for the time being. But FDA 

often says they don’t have the resources, but 2007, $1.97 billion. 

2008, $2.269 billion. 2009, about—a little less actually, $2.667 billion, and now your proposal is almost $3.2 billion, which would be 

a 37 percent increase over the short 21⁄2-year period of time. 

Now it’s interesting, you know, during that period there have 

been—your employee count has gone from about 9,500 with the 

proposal to go up to 12,000 employees. You know, when the private 

sector is cutting back, when households back home are cutting 

back, is it really fair for FDA to have a 37 percent increase? And 

I’m not aware—and I may be wrong but—of your suggested savings 

or cuts that you have proposed. And are there any? 

Dr. SHARFSTEIN. In this budget? 

Mr. KINGSTON. Yes. 

Dr. SHARFSTEIN. Let me—— 

Mr. KINGSTON. Could you find anything to reduce, any duplicate—duplications or anything like that? 


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FDA’S BUDGET

Dr. SHARFSTEIN. I think it’s a very fair question. And overall, 

given the state of the economy and the budget, I totally understand 

the question. I think it’s important to put the FDA budget in two 

types of contexts. One is the years before the years that you mentioned. Because if you go back further, there was the erosion of 

FDA’s budget considerably. It was held flat for many, many years, 

and the number of employees dropped considerably. 

And I think the reason for the increase in the budget was the 

widespread understanding that the erosion of the FDA was hurting 

not only the health of people but the health of businesses as all 

sorts of problems were happening, and FDA was really unable to 

prevent them or respond in a way that people really felt confident 

about. 

Mr. KINGSTON. Well, let me ask you that. What are those numbers in terms of—why you don’t go back to say 2004, tell me what 

erosion specifically was. 

Dr. SHARFSTEIN. I think you could go back even further. I don’t 

know if I have them handy, but I would go back even to like the 

late 1990s and you could see—I think—I don’t want to give you 

statistics I don’t have right in front of me, but I think there was 

a considerable decline in the real budget at FDA, and there was 

a big drop in the number of employees in particular programs. 

Mr. KINGSTON. Well, that’s certainly relevant, and maybe—do 

you have your budget person here? 

Dr. SHARFSTEIN. Yes. Patrick. 

Mr. KINGSTON. Can you give me those numbers? 

Mr. MCGAREY. What Dr. Sharfstein points out is consistent. Over 

about a ten-year period, with the recent increases brought in, we’re 

about returning to where we were—— 

Mr. KINGSTON. So when were you at $3.1 billion? 

Mr. MCGAREY. What our staffing will be? 

Mr. KINGSTON. No. When were you there? Was that 2003? 

Mr. MCGAREY. Excuse me. I apologize. We were never—I’m focusing on the number of employees that that money buys. 

Mr. KINGSTON. Okay. So you were at 12,000 employees previously? 

Mr. MCGAREY. We were just slightly below that if you go back 

a decade. 

Mr. KINGSTON. Okay. Can you give me those numbers for the 

record? 

Mr. MCGAREY. We’ll get those for you. 

[The information follows:] 


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Mr. KINGSTON. Because I’m very concerned about a 37 percent 

increase. And one thing to consider now versus ten years ago is 

that the national debt is so much higher, and I would also think 

that the FDA would be able to take advantage of some of the technology that’s out there now that—you know, for example, what 

HACCP has done for USDA going from a carcass-by-carcass inspection to microbial inspection. I would think that the FDA would 

have the same sort of advantages with all the technology that 

might be able to be a savings. 

Also, I wanted to talk to you about these user fees. Every Administration—and you have been on the Hill, and you know. You’ve 

seen—you were here when President Clinton was here and Bush, 

correct? 

Dr. SHARFSTEIN. No. No. I started July 2001. 

Mr. KINGSTON. Okay. Well, you know that every administration 

rolls out user fees. And yet rarely do user fees get beyond this 

hearing. And because I’ve just—I’ve never seen the Clinton Administration, the Bush Administration, I do not think the current new 

Administration is going to fight for user fees, but I could be surprised. Can you give me an indication of what you’re hearing in 

your dying days as interim director? 

[Laughter.] 

USER FEES

Dr. SHARFSTEIN. My understanding is that this Administration is 

committed to the user fees as part of its plan to really support 

FDA. And, you know, we’re kind of doing our best to make the case 

for them because we think that in order to transition to the system, 

the food safety system that you’re talking about, and I agree with 

100 percent on the HACCP and those principles and getting away 

from having to think of it in terms of how many inspections we’re 

doing, and in terms of what standards are in place, whether the 

businesses have the responsibility to do it. We’ve got to get over 

that hump, and we need resources to put that system into place. 

And that’s really our goal. 

Mr. KINGSTON. Okay. Thank you. My time has expired. 

Ms. DELAURO. Mr. Jackson. 

Mr. JACKSON. Thank you, Madam Chair, and thank you Dr. 

Sharfstein, for your service to the nation. I have two questions, one 

regarding neuroblastoma, and the other regarding generic drugs. 

Dr. Sharfstein, both the House and the Senate encouraged the 

FDA to prioritize review of new treatments and clinical trials for 

pediatric cancers in Fiscal Year 2009, particularly those related to 

neuroblastoma. It is clear to me that we can do better by young patients facing a dismal 20 percent survival rate from this terrible 

disease, a survival rate which, unlike other pediatric cancers, 

hasn’t improved in decades. 

New treatments and clinical trials that have the potential to help 

children with neuroblastoma should be reviewed with all due 

speed. This is particularly true of therapies for relapsed patients 

who face a survival rate of less than 5 percent. I guess I’m asking 

if you can please put neuroblastoma on your radar screen as an 

area, one, that needs attention, and can we work together to try 


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to make progress in this area so infants and toddlers battling this 

disease can access all promising treatment options? 

Dr. SHARFSTEIN. And I would answer yes, I think it is very important, particularly as a pediatrician, I’ve actually cared for patients with neuroblastoma, and I’ve seen patients die from neuroblastoma, and it is just an incredibly difficult experience for everybody who is in contact with the child, as well as obviously the 

child. 

I think one of the things that Dr. Hamburg and I strongly support is the FDA not just being passively sitting back waiting for applications to come in, but where we think there may be opportunities for innovation that can save lives, to really reach out and help 

researchers and industry think about what it would take to demonstrate that a product works and is safe for kids. 

So I look forward to working with you and your office on identifying better treatments for neuroblastoma and other diseases affecting children. 

Mr. JACKSON. Dr. Sharfstein, we also can agree that generic 

drugs can save patients substantial health care costs. However, 

hurdles still exist in bringing more affordable drugs to patients 

who desperately need them. As the number of generic drug applications rise, staffing at FDA has relatively stayed flat. What needs 

to be done to increase the amount of generic drugs being brought 

to the market, and are new user fees the only way? 

GENERIC DRUGS

Dr. SHARFSTEIN. Thanks for that question also. I recently saw 

my uncle, who is a neurologist, who said that he has a lot of patients who skip doses of medicines and put themselves at risk for 

seizures because they can’t afford their medicines. And generics are 

an extremely important way for people to get access to medications 

that are safe and effective. 

I think that—and this reflects the previous question—I think 

there is reason to be optimistic about user fees. I think that the 

industry is open to that idea. I think the Administration is very interested in it, and I think, just like the user fee arrangements have 

been made in several other areas, I think that this is really important. I think more resources are critical, but we’re also going to 

look to see whether there are other things we can do to streamline 

the approval process for generics. 

Mr. JACKSON. Thank you, Dr. Sharfstein. Thank you, Madam 

Chair. 

Ms. DELAURO. Thank you, Mr. Jackson. Mr. Latham. 

Mr. LATHAM. Thank you very much, Madam Chairman. Doctor, 

the Administration is requesting an increase in the overall budget, 

$510 million. Just last year, the Administration came and asked for 

a $375 million increase, and I think it was Senator Kohl over in 

the other body asked the question to the administrator last year if 

the FDA could absorb that much money in one year, and it was 

just a flat no, we can’t absorb that much money. It wouldn’t be well 

spent. And I guess I would ask you the same question. How do you 

absorb an increase, $510 million in one year, to have the money to 

be well spent? Is it possible? Last year they couldn’t absorb a $375 

million increase. 


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Dr. SHARFSTEIN. You know, I’m going to probably turn to Patrick 

McGarey to talk a little bit about the process in place. I understand—my understanding is that FDA has been able to spend all 

the money that it has been given by Congress. 

Mr. LATHAM. Are there any unobligated funds? 

UNOBLIGATED FUNDS

Mr. MCGAREY. Well, in the current fiscal year, of course, we don’t 

have that situation because it’s available to obligation until the end 

of the fiscal year. We have an aggressive hiring plan because so 

much of our budget and our mission relates to our staffing, and we 

are about at 80 percent of our hiring targets for the fiscal year, and 

realizing of course we’re between 60 and 70 percent through the 

fiscal year. So on our priority goal of hiring, we’re meeting those 

targets. We’re going to spend more than $400 million in the current 

fiscal year, and we feel in the coming fiscal year, we’ve poised ourself to make expenditures at the $510 million level. 

Dr. SHARFSTEIN. Looking at that, there are chunks of money that 

are really for the development of IT systems, which we can obligate 

this year, and which aren’t necessarily needed every single year, 

that amount of money. But that’s what helps us get us over the 

hump to—— 

Mr. LATHAM. So how much of those funds are left unobligated? 

Dr. SHARFSTEIN. I don’t think there’s an unobligated part of IT. 

Mr. MCGAREY. Well, much of it is unobligated at this point in the 

fiscal year. 

Mr. LATHAM. Well, he said he couldn’t spend it this year. 

Mr. MCGAREY. And we will spend it before the end of this fiscal 

year. Our major IT contracts, we’re going to put money into those 

in the coming quarter. 

Mr. LATHAM. And last year as far as food safety, you were granted authority to hire 161 new full-time equivalents in food safety. 

Do you know where you are on those hires? 

Mr. MCGAREY. Again, we are at about 80 percent across FDA, 

and it’s very similar to that in the food safety hiring goal that we 

have for that piece of our budget. 

VETERINARY MEDICINE

Mr. LATHAM. The Center for—and in your testimony earlier you 

talked about working with the states and about surveillance and 

all that type of work. One of the key parts of it is the Center for 

Veterinary Medicine. And in the budget, it really only gets, what, 

$2 million, as far as an increase. And the GAO indicated in a Senate oversight hearing that the Center is in a state of crisis because 

there aren’t enough vets out there working in the center. 

I don’t know, I wonder if there are some unobligated funds and 

you can tell me what the priorities are, but you know, if there’s 

some funds, rather than worry about whether Cheerios are regulated as a drug, it might be a good idea to look at that as far as— 

the whole system out there is going to break down if you don’t have 

these people out doing their job on the front lines. I don’t know if 

you want to comment, or—— 


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Dr. SHARFSTEIN. Sure. I think that—I’ll turn at the end to Patrick on the increase in veterinary medicine. I think it may be more 

than $2 million. But to your general point—— 

Mr. LATHAM. As far as an increase? Okay. Go ahead. 

Dr. SHARFSTEIN. How much is it? 

Mr. MCGAREY. Between last year and this year, the increase for 

the program for animal drugs and fees, is 36.7. 

Mr. LATHAM. But how about for hiring? 

Mr. MCGAREY. Well, probably on average, 70 to 75 to 80 percent 

of that Center’s investments will be in staffing. 

Mr. LATHAM. Okay. My question then would be why the GAO 

says that the Center for Veterinary Medicine is in a state of crisis? 

Can you address that? Why and what are you doing about it. 

Dr. SHARFSTEIN. Well, I think that—I wish I had a mental image 

of that GAO report, but I don’t have it. But I do think that there 

are several very important—— 

Mr. LATHAM. You’re not aware of a crisis at—— 

Dr. SHARFSTEIN. Well, I think that what my understanding of 

the situation in Veterinary Medicine is that—and if you can look 

back to the melamine pet food situation that happened, which I 

think people recognized as a major crisis. And not only that so 

many animals died, which was terrible, but that it took so long to 

really figure it out, and that the processes for fixing it were—where 

it took so long. And I do consider that a crisis. And I’ve been impressed that the Center now has a very strong plan to put in place, 

and I was mentioning that a little bit. This integrated system with 

the state, locals and veterinarians to identify problems in animal 

feed and be able to respond. 

So that is something that is getting a lot of funding in this budget, and I think it’s extremely important. As the health commissioner in Baltimore, I was the chair of the board of the animal shelter. And, you know, I think that there is tremendous importance 

to people and importance to the animals themselves of, you know. 

Mr. LATHAM. How many more vets are you planning on hiring? 

I apologize, but I just—to close it off. 

Dr. SHARFSTEIN. How many more vets are we planning to hire? 

Mr. LATHAM. Yes. 

Dr. SHARFSTEIN. I don’t know that off the top of my head. We 

may have to get back to you. 

Mr. MCGAREY. We would have to get that for the record. We certainly couldn’t tell—— 

[The information follows:] 

FDA HIRING PLANS FOR VETERINARIANS

FDA’s Center for Veterinary Medicine plans to hire approximately 25 Veterinarians during FY 2009 and FY 2010, based on the FY 2009 enacted budget and the 

FY 2010 President’s Budget. 

Mr. LATHAM. Thank you, Madam Chairman. 

Ms. DELAURO. Thank you, Mr. Latham. Mr. Farr. 

LOUISVILLE INSPECTIONS

Mr. FARR. Thank you very much. Thank you for your public service with your incredible background, academic background, medical 


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background in pediatrics and so on, I just—I think it’s nifty that 

you’re dedicating your life to public service. 

I have a question that arose from my—every year I visit the UPS 

centers in my district and talk to the drivers and learn a lot about 

how we transport things. And it came to my attention that the 

FDA has to inspect all the packages shipped out of country to ensure that there’s no violation of U.S. health, food and safety laws. 

And the FDA provides inspectors to shippers like FedEx and UPS. 

But last year the FDA pulled its night inspectors from its UPS hub 

in Louisville, citing a lack of personnel, even though it had provided plenty of personnel to the same job for FedEx in Memphis. 

And I understand that UPS worked out a deal with FDA to undergo a six-week trial test to see if indeed UPS was handling the volume of packages that qualified for the nighttime inspectors, and it 

did. 

The problem is that the inspectors haven’t been provided, and 

this delays getting packages to consumers and creates an uneven 

playing field between UPS and FedEx. What’s holding up the FDA 

from responding to getting those nighttime inspectors? 

Dr. SHARFSTEIN. It sounds like a very fair question, particularly 

when it comes to the uneven playing field between different companies, and I don’t know the answer to that, but I can promise to look 

into it and get right back to you. I think you deserve a good answer 

to that question. 

[The information follows:] 

UPS HUB AT LOUISVILLE

FDA recently completed a six-week pilot of entry reviews for the UPS Louisville 

hub location. FDA determined that the FDA Memphis Resident Post is the best location to review UPS entries. At this time, FDA is working with UPS on logistical 

issues and has begun identifying processes and procedures that need to be developed before FDA can review entries of UPS packages from the Memphis Resident 

Post. 

IND APPLICATIONS

Mr. FARR. Thank you. I appreciate that, since you, you know, reviewed it and came to the conclusion that the volume is there. Another question came from visiting compounding pharmacists and 

learning a lot about compounding business. It’s very interesting. 

And I’m very supportive of it, by the way. 

The FDA banned the use of esterol, which is a natural occurring 

hormone in compound medicines to treat hormone replacement 

therapies. And I understand that a pharmacist can apply for a— 

file an IND, an Independent New Drug application? 

Dr. SHARFSTEIN. Correct. 

Mr. FARR. In order to do it. But this application process can be 

as many as up to 50 pages long, very complicated, costly to fill out. 

Consequently, doctors don’t like to do it, pharmacists don’t like to 

do it. And those who find—who have done it, find that their requests generally get denied. Is there any effort to simplify this 

process so the filing can be done in a—since you’re not doing any 

test to decide whether esterol should be in compound medicines, 

that this is the only way one can get the exception, and is there 

anything going on to simplify this process, and at least give a decision up front? 


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Dr. SHARFSTEIN. Also a very fair question. You know, the big picture on compounding from my perspective—I’m a pediatrician. A 

lot of drugs are compounded for kids because they can’t be made 

available another way. And so I’ve written for drugs that are compounded in clinical medicine, and I understand the importance of 

compounding to the practice of medicine in the United States. 

I think the concerns comes when the agency thinks, or becomes 

concerned that compounding is at such a scale that it is sort of like 

drug manufacturing potentially for drugs that could be unsafe or 

not well presented to consumers. And my understanding of this 

particular issue is that there were some people who were selling 

this at a mass scale, a drug that’s very similar to the approved estrogen, but with making claims about its safety that were almost 

certainly untrue, that it wouldn’t have the adverse consequences, 

and that proved a risk to women’s health. And I think that’s what 

led to the action that FDA took. 

Mr. FARR. Mm-hmm. 

Dr. SHARFSTEIN. But FDA did provide, just as you are setting 

out, an option for people which allows some assurance that people 

will get more of the facts about this particular type of product and 

then would allow them to get it. But I understand that FDA is— 

has sought to meet with the compounding pharmacists to develop 

a quick way to get the IND going, and it has some trouble getting 

people to the table to talk about that. But in the absence of that 

meeting, that they did develop a website that explains exactly how 

to do it. But if that’s not working for people, we want to know. And 

I’m sure FDA would be willing to sit down with the compounding 

pharmacists associations again to work on that. And I do know 

that some people have made it through the process. 

So I think the thing to do may be to understand who is expressing that concern and offer to meet with them and see what we can 

do to make this particular pathway, which would allow people access to the medicines under conditions that they be going in with, 

you know, kind of both eyes open. If we could streamline that pathway, I think that would be something that could be mutually beneficial. 

Mr. FARR. Okay. We’ll follow up on it. Thank you. 

Ms. DELAURO. Mr. Alexander. 

FTE

Mr. ALEXANDER. Thank you, Madam Chairman. Doctor, I have a 

couple of questions for you, but first Mr. McGarey, going back to 

something that Mr. Kingston was talking about a while ago. You 

said that the lack of funding that you need goes back to the 1990s. 

That’s the first time in a while that I’ve heard anybody not totally 

blaming President Bush for the problems that we have now. I’m 

certainly sure that he’ll appreciate that. 

But you said that at one point you were not at 12,000 but a little 

less than 12,000 employees. Is that correct? 

Mr. MCGAREY. Well, we won’t be at 12,000 in the current fiscal 

year. The target is to reach that at the end of Fiscal Year 2010. 

Mr. ALEXANDER. But you said at one time you were almost at 

that—— 

Mr. MCGAREY. I know we were above 10,000. 


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Mr. ALEXANDER. Okay. 

Mr. MCGAREY. At the end of Fiscal Year 2008, we were below 

10,000. 

Mr. ALEXANDER. Were conditions at that time better than they 

are today in your opinion? 

Mr. MCGAREY. Well, I—my service doesn’t go back that far, but 

talking to people who have been at FDA, conditions is a broad 

term, but there are many drivers our workload that are pressing 

now, and we deliver our mission with employees. 

Mr. KINGSTON. Will the gentleman yield? 

Mr. ALEXANDER. Sure. 

Mr. KINGSTON. I want to make a clarification. This was your employee count in 1998, 8,841; 1999, 8,869; 2000, 9,406. So we’re not 

talking about returning to a level that was over 10,000. I’m not 

sure what year you’re talking about, but that’s not accurate with 

what this is. Now maybe it dipped up in 2001. 

Mr. MCGAREY. I would point out, the actual at the end of Fiscal 

Year 2008 was 9,811 employees. So we’re in the year where we’re 

seeing a lot of growth, and I guess I was looking at a ten-year span 

where we were—— 

Mr. KINGSTON. Well, I just want to clarify because my understanding from your answer to me was that you’re returning, but 

you’re not returning according to this. 

Mr. MCGAREY. We would be happy to request a table that lays 

out the FTEs across those decades. 

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Mr. KINGSTON. I yield. 

Mr. FARR. Thank you. Reclaiming my time. The reason I asked 

that is looking at data, CDC data, and I certainly don’t want anybody to think that we’re implying that they’re misleading us, and 

for sure we don’t want anybody to think we’re calling them liars, 

but on this data sheet it says that 300 million Americans eat three 

meals a day. We know that’s not accurate. Three hundred million 

people do not eat three meals per day. But even at that, they say 

that at 5,000 deaths, we have a 99.99 percent success rate. Five 

thousand deaths to me would seem like it would be a lot less than 

99.9 percent success rate. 

But getting to the question is when we had the number of employees that you would like to have, were we better than 99.99 percent successful? 

Dr. SHARFSTEIN. Let me address that. I think that the number 

of employees is an important thing to follow up on, but it’s one part 

of the complexity of the budget situation. And if you go back and 

compare a decade to now, the market for foods, the market for 

drugs, the complexity in the science has expanded tremendously. 

Even if you just look at imports, number of imported foods, and 

the number of establishments importing to the United States has 

gone up tremendously. So the complexity of what FDA is dealing 

with sort of probably the best—and not just the complexity, but the 

amount of things that FDA is dealing with is also something you’ve 

got to factor into as you’re looking at what the appropriate amount 

of resources for the agency is. 

I think that 5,000 deaths is too many. And ideally, you wouldn’t 

have people dying from the food that they’re eating. Now do I think 

that the measures that we’re going to be putting into place will reduce that number? I do. I don’t think it’s entirely based on the 

number of resources or the number of people, but what we do with 

that. And I think that the shift to what Congressman Kingston was 

talking about, a prevention-oriented system, is going to lead to reducing that. And ultimately, we have to measure our success by 

how many people are dying and how many people are getting sick, 

not how many people are we hiring or, you know, how many buildings are we building. And this gets to the management question 

that the chairwoman was raising, that if we can’t demonstrate that 

you’re getting important value for the resources at FDA, then we 

don’t deserve the money. 

IMPORTED SHRIMP

Mr. FARR. Just one more question. I wanted to ask about—we 

understand that only about 2 percent of the shrimp that are imported are tested. Do we know if that number is correct? 

Dr. SHARFSTEIN. That’s probably about right. I think for food in 

general, it’s about 1 percent. So that may be a little high. I’d have 

to look exactly for shrimp, but. 

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Mr. FARR. So since we import about 90 percent, we’re told, of the 

shrimp that we consume, and we’re only testing 2 percent, that 

should probably cause us concern, wouldn’t you—— 

Dr. SHARFSTEIN. Well, I think this gets to the question of whether testing and inspections is the measure of safety or not. And, you 

know, FDA could show up with a budget request that is truly astronomical if the idea was that we should be testing all imports or 

inspecting all facilities annually. But we’re actually trying to use 

the resources in a way to establish a system that doesn’t require 

that kind of testing. So one of the things that FDA is doing on 

shrimp is, there’s a pilot project to certify a program that would basically train auditors and inspectors to do prevention-oriented work 

with all the different foreign shrimp producers so that we have confidence that the foreign production of shrimp is done under a prevention-oriented system, then you’re just using testing to kind of 

check. And two percent might be fine at that point. If you don’t 

have a strong prevention-oriented system in place, then you’re kind 

of stuck just thinking about it as testing, but that’s something that 

turns very expensive very quickly. 

So I think the principle is, we have to be assured that the system 

for production, both in the United States and internationally, is 

based around prevention, and then we do targeted testing to assure 

that rather than we have to test everything that’s coming in, because even then you could miss stuff if the actual system isn’t 

sound underneath that. 

Mr. FARR. I know a lot of us have farm-raised fish farms in their 

districts, and we’ve been concerned about the increase in the number of imports fish, so-called catfish, from countries we’re concerned 

about not only the processing the facilities, the cleanliness of them, 

but where those fish are raised, we’re concerned about that. And 

then the other day we were told—we were talking about catfish— 

that we really have never even identified what a catfish is. So that 

really causes a lot of concern. We don’t know whether some of 

those fish coming in from other countries can even be classified as 

a catfish. 

Anyway, thank you for being here. 

Dr. SHARFSTEIN. Thank you. 

Ms. DELAURO. Then my colleague raises an interesting question, 

which I intend to explore further on, which is about the issue of 

equivalency and in standards. And having to do with FDA, which 

at the moment does not have any system of equivalency, though 

you have stopped a whole lot of product coming in from China just 

in January, probably within 800 or so different kinds of products 

have been stopped from coming in to China. And I’ll just say to my 

colleague at the request of a number of colleagues move catfish to 

FSIS in the farm bill. It was of concern to me at that juncture. It 

was a concern to me right now. Mr. Hinchey. 

Mr. HINCHEY. Thank you very much, Madam Chairman, and 

thank you very much, Commissioner Sharfstein. 

It’s interesting to listen to you. You seem to be dedicated to your 

responsibilities here with this job and that’s very important. What 

you’re doing is critically important to the health and safety and security of people all around this country, and that’s something that 

we need very, very well. And the importance of the FDA is someVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00097 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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thing that the chairman of this committee is focused on over the 

last several years in a very significant way, trying to make sure 

that this system works better. 

GENERICS

So I just want to ask you a couple general questions, and thank 

you very much for everything that you’re doing. One of them has 

to do with the generics, generic drugs, and the expense of these generic drugs and the ability of people to buy them. With the downturn in the economy it’s making it increasingly difficult for people 

to be able to afford these generics and there is less and less generic 

options for a substantial amount of these drugs that are very important for people’s safety and security. So I wanted to ask you. 

What is the generic drug backlog now, and how does it compare to 

the past. And, also, can we get a commitment from the FDA to ensure that there will be enough staff to always keep the generic 

drug backlog below a reasonable number so fewer people are inhibited by it. 

Dr. SHARFSTEIN. Thank you. I think it’s a very important question. Generics are extremely important in U.S. medicine. 

Mr. HINCHEY. I can’t hear you very well. 

Dr. SHARFSTEIN. Oh, I’m sorry. Thank you. 

Mr. HINCHEY. Thanks. 

Dr. SHARFSTEIN. No problem. I was just saying that generics are 

extremely important in American medicine and to many, many, 

many patients. Many people in Baltimore where I was health Commissioner really relied on generics and we were active in working 

with certain companies making generics available very cheaply to 

make sure that that information was know to patients. I think that 

the fact that there’s such a backlog, my understanding is that it’s 

about 1300 applications is definitely of concern. 

I don’t think all of them necessarily are like ripe for approval 

right away, but that that’s sort of what’s in the pipeline and the 

need to increase resources and other types of measures is very important, and I think is something the President is counting on in 

part to reduce healthcare costs. And I think that’s why we expect 

pretty strong backing for a user fee program for generics that 

would give considerable new resources, allow us to hire, I think, 

about another 60 or so people for the generic program and really 

make a dent in those numbers. 

Mr. HINCHEY. So you are moving this in the right direction apparently and you are concerned about it, and you are trying to improve it as much as possible. 

Dr. SHARFSTEIN. Yeah, this is very important, no question. 

USER FEES

Mr. HINCHEY. Yeah, well, good, and look forward to working with 

you on that. One of the issues that we have dealt with over the 

course of the last several years if the Food and Drug Administration’s dependence to a considerable extent financially on the drug 

industry, because of the financial interaction between the regulatory agency and the operations that are supposed to be regulated. 

In fiscal year 2001 the fees paid by the drug companies at that 

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Last year those fees comprised almost 50 percent of the drug program’s budget and nearly a quarter percent of the FDA’s overall 

budget. And that, of course, is something that has been a great 

concern for a number of people on this committee, including our 

chairman and others. We’ve been trying to deal with that issue and 

make it work much better than it has. 

So I’m wondering if you can tell us how much of the FDA’s budget is expected to come from drug user fees in fiscal year 2010. Now, 

that may be down even though it stays at the same level. The percentage of it may be down, because of the fact that the budget is 

going up, and appropriately so going up. But I’m just wondering 

how much of the FDA’s budget is expected to come from drug user 

fees in this upcoming fiscal year, and what steps are currently 

being taken to end the FDA’s close financial ties to the industry 

that it oversees. 

Dr. SHARFSTEIN. So I understand, if I am looking at this correctly, that the overall drug program is about—I’m going to have 

to make sure I get this right—an overall for the agency the total 

budget is $3.2 billion, and the number of user fees is 800 million; 

but, if you’re looking particularly at the drug program—I don’t 

want to get the number wrong—so I might ask about that. 

Mr. HINCHEY. Yeah, the numbers are important, but I’m more 

concerned about what your attitude is going to be and what your 

plans are, the direction in which you are going to be moving. 

Dr. SHARFSTEIN. Well, let me tell you my attitude about it. I 

think it’s certainly true the percentage of FDA’s budget that is 

comprised of user fees has been increasing, and I think that I understand the concern people have made or expressed that user fees 

create perception or a conflict with the agency’s work. And, I think 

from my perspective, I think these concerns reflect a broader lack 

of trust in FDA that goes deeper than questions about the agency’s 

sources of income. 

And I think the most important thing that Dr. Hamburg and I 

can do is renew the public’s confidence by acting with integrity and 

transparency by sending the signal inside and outside the agency 

that we will make decisions based on the best available scientific 

evidence and not on influence that’s inappropriate and make sure 

decisions are not unduly influenced at any point, and I think that’s 

something we are very interested in following through on, and 

we’ve already started some efforts in that regard. 

As far as the user fees themselves, my view is it depends on the 

type of user fee and the rules about the user fee. I think that when 

I go to the MVA and I pay for a license, I am not getting a lot of 

consideration aside from the MVA in response to that. And I think 

that one of the things you see is you look back on the history of 

the user fee program at FDA is what the user fees have been allowed to pay for has changed, and I think that has moved in the 

right direction. So that money that comes with fewer restrictions 

and allows important safety work to happen is going to have less 

of the concerns. 

Mr. HINCHEY. Thank you. I appreciate that. But what I am concerned about frankly is in the context of this operation the ability 

of the operation that is being overseen having an opportunity to influence the decisions that are being made based upon the money 


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that they are putting into the process. That’s the important thing, 

and I am sure you will be focusing on it. 

Dr. SHARFSTEIN. Right. I hear your concern. 

Ms. DELAURO. Thank you, Mr. Hinchey. 

I would just like to add to the conversation of my colleague, Mr. 

Hinchey, in this way. And that is I have always felt over the years 

that the user fees were never meant to outpace appropriations and 

that is in fact what exactly has happened. And it is not being part 

of the effort, but in effect in my view in control of the effort that 

I see compounded by a study by a Harvard Professor, ‘‘New England Journal of Medicine’’ in 2008, said that ‘‘Since 1993 the first 

year of PDUFA drugs approved closest to the review deadlines had 

higher rates of serious safety issues in later years than other 

drugs. 

That was disputed by the FDA. Professor Reed checked his data. 

Months later he published his raw data in an 151-page memo 

where he made some corrections, but he stood by his original conclusion. And the most recent legislation, FDAAA, gave FDA longneeded power to order safety measures when approving drugs. But, 

before that, FDA reviewers with questions about safety issues 

could only request post-market safety studies, the large majority of 

which were never even started by the companies ordered to do 

them. 

I think it’s probably not surprising that we have serious safety 

issues emerging years later. I am going to ask for your thoughts 

and this is not where I was going in terms of a question, but I 

think it is appropriate at this juncture to lay that on the table and 

ask to get your thoughts about that before I move. 

FDAAA

Dr. SHARFSTEIN. Let me respond in two ways. The first is the 

FDAAA legislation was extremely important. It came after a very 

important Institute of Medicine report when I was on the board. I 

joined the board that did that report after that report was done 

and I am very familiar with it. And I think it did give very important authorities to FDA when that legislation passed; not just require studies, but also to require label changes and to require risk 

management strategies for drugs that are marketed. 

And I think all those things, plus the flexibility and the user fees 

to spend more on safety, is going to strengthen what FDA can do. 

And I do think there is—and I want to respond in a slightly different way also—which is I think ultimately if the history of the 

FDA—and I definitely would commend Phillip Hills’ book ‘‘Protecting America’s Health’’ on this—is that there is not such an opposition between a strong FDA and a strong industry. 

In fact, if you look back on the history of the FDA, when FDA 

has had trouble with regulation or their having had authority and 

people have been injured and all sorts of problems have happened. 

It is undermining confidence in the industry, and the industry financially has suffered pretty dramatically. And if you look across 

the last century you see that when FDA does its job fairly and reasonably in the interest of public health, even if it is strengthening 

its oversight, the industry actually does well. And I think that, you 

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sions for public health, but I have every expectation that as we do 

that and as we are able to strengthen the credibility of the agency, 

that the industry in the long term will benefit too. 

Ms. DELAURO. I would just say this to Dr. Sharfstein. It is not 

something I haven’t said from this microphone over the last several 

years. I think what specifically happened with regard to the FDA, 

that it lost its mission; that it is a regulatory agency. It has not 

functioned as a regulatory agency. I would just submit to you that 

part of that problem has come from undue influence of an industry 

and I do believe that the user fee issues have had an effect on that 

process, have made it more difficult. I believe that is one of the single biggest efforts that you and Dr. Hamburg have to take a hard 

look at to restore the regulatory mission to this agency, self-regulation has failed. It has failed unmercifully in our financial institutions and we have been brought to our knees financially. 

Now, that is one level of difficulty when this agency doesn’t regulate the products that it is supposed to regulate, people die. That 

is the result; and, I believe on both sides of the aisle on this committee, we want to return the regulatory function to this agency. 

Let me just comment. Let me go back on the issue of budget increases and food, and taking a look at the testimony, I was a little 

bit concerned. 

Lots of useful activities, stepped up inspections, honestly a lot 

sounds to me like buzz words from a prior administration working 

with stakeholders and probing risk communication. This is a real 

change, a real change from the past would be a plan on food safety 

that identify the foods at greatest risk, that dealt with enforceable 

performance standards on pathogens, E.Coli, salmonella, listeria, 

and those performance standards could be developed with industry. 

Looking at a system akin to a HAACP system that allowed for 

sampling and contamination, and a requirement that that had to 

be reported back to the FDA to looking at how we do base facilities 

on risk and then developing a system for inspection, because we 

cannot inspect everything. But if we do not have data and information to base on that risk that which would seem to me that we are 

not going to get anywhere here and a strong certification process 

for imported foods, I don’t see very much of that in testimony. I 

know you are there a short time. 

Dr. Hamburg is not even there at the moment, but these are the 

kinds of changes that I am looking for with regard to the food safety aspect of the FDA. And, you know what my position is on where 

food safety ought to be. I don’t have to repeat that here, but will 

we see these kinds of changes from the FDA? In the future I will 

make another point: Energy and Commerce is going to produce a 

piece of legislation in short order. 

If we are to move in direction seriously on food safety are these 

kinds of requirements in that piece of legislation, and will you support these kinds of requirements in that legislation? The train has 

left the station on food safety and I need to know from FDA’s perspective if you will support these kinds of efforts in a food safety 

piece of legislation. 

Dr. SHARFSTEIN. Thank you. Excellent question, I think. 

The budget testimony kind of runs down the general areas where 

the money is going to go. It’s not oriented in terms of the priorities 


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for food safety, and I think my list of priorities for food safety 

would be very similar to yours. It’s not about meeting with stakeholders. It is about putting in place a modern, regulatory system 

for food that’s premised on prevention, and I think that is the gist 

of the Commerce Committee bill which I fully expect we’ll be able 

to support. 

I think the food safety working group, which I met the other day 

when you were there, talked about that. Those are the principles 

that we are going to support. There is a tremendous amount of new 

authority that FDA needs to be able to accomplish that, but at the 

same time we are proceeding as if, you know, we are going to get 

it. And, we are working very hard within FDA to develop regulations around GMPs that need to be revised, an approach to prevent 

good standards of the HASAP model and others that could be put 

in the enforceable. 

And I met multiple times with industry groups and that’s what 

they want too. You know, and I think if we don’t see results in 

those ways, the FDA is not succeeding in food safety and I think 

Dr. Hamburg and I are going to make that an extreme priority. 

And our progress has got to be measured and the implementation 

of those things, not in the number of people hired necessarily. I 

mean those things we think are important to get there, but that’s 

not actually progress, nor is the number of inspections progress. It 

is those other things that are going to represent progress. 

Ms. DELAURO. Thank you. 

I went over and I apologized to Mr. Kingston. 

Mr. KINGSTON. Thank you, Rosa. 

Dr. Sharfstein, I wanted to take in the numbers the CDC and Inspector General has given us. There are 76 million food borne illnesses reported a year; 300,000 hospitalizations; 5,000 deaths. Everybody on the same page on that? 

Dr. SHARFSTEIN. Yes. 

Mr. KINGSTON. Okay. 300 million Americans eating three meals 

a day, no snacks. It is 9 million meals eaten daily times 365 days 

a year. That’s 328 billion meals a year and so if you divide that 

by the food-borne illnesses, you actually come up with a rate of safe 

food at 99.98 percent. Correct? I mean this me. I want to make 

sure that there’s no editorializing or fudging here, so that is the 

mathematical model. I mean that’s the mathematical reality. Correct? 

Dr. SHARFSTEIN. The vast majority of food in the United States 

is safe. No question! 

FOOD SAFETY WORKING GROUP

Mr. KINGSTON. Right. So where I am confused is with food safety 

being at 99.998 percent safe, is the goal of the FDA specific in 

terms of food safety or is it this general political where we need 

more food safety? And the reason why I say that to you as a scientist, how do we measure it? Will it be on, okay, we had less than 

300,000 go to the hospital? Or do we have less than 5,000 deaths? 

I mean, where will the metrics be? 

Dr. SHARFSTEIN. That’s a very important question. The food safety working group or the President has identified that as one of the 

top priorities. And when the food safety working group comes out 


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with its report, you are going to see this is what we mean by 

progress and food safety, and it is going to be very specific. 

I do think we want to see fewer deaths and fewer hospitalizations; and, you know, you can look at these numbers from different 

perspectives. As a physician, I have taken care of kids who have 

been very sick from food borne illness, and I will never forget a little girl I took care of who had hemolytic uremic syndrome from 

E.Coli 015787 and she was in renal failure. She was on a fluid restriction and she was begging for water, and her parents couldn’t 

give it to her. 

And I’ll never forget that. And I think it’s sort of like when you 

have that kind of thing that is preventable, and now I think if you 

get to a point where you decide, you know, there’s just not more 

that you can do to make it preventable, then that’s where you are. 

But when you have preventable illness. 

Mr. KINGSTON. What I want to make sure is we have a specific 

goal in mind. 

Dr. SHARFSTEIN. Yes. 

Mr. KINGSTON. Because I do think that another thing we never 

talk about in this committee is the 300,000 hospitalizations or the 

5,000 deaths. How many of those people actually had a broken immune system to begin with? Perhaps this little girl I don’t know, 

and certainly wouldn’t want to base decisions on anecdotal evidence any more than you would as a scientist. 

But the other question is how much of this could be prevented 

with consumer education. You know, like we have always been 

told, do not put the cooked hamburger back on the same plate that 

you put the raw hamburger when you are taking it to the grill unless you have washed it. Do you know the breakdown of that 5,000, 

how much of this was in the household versus anything in the food 

processing commercial side of it? 

Dr. SHARFSTEIN. My understanding, generally speaking, that 

about two-thirds of the illness are from FDA-regulated products 

and about a third from USDA; and, so, the meats would be about 

a third and the other types of food would be about two-thirds, 

but—— 

Mr. KINGSTON. So, I want to make sure I understand. 

Dr. SHARFSTEIN. But don’t stop me answering your question. 

Mr. KINGSTON. Yeah. No, but what you are saying about a third 

of it is something that happened in the household that could not 

be regulated. Is that? 

E.COLI

Dr. SHARFSTEIN. Well, no; not exactly. I think that for some problems that happened in food safety, you know, for example all E.Coli 

that’s in meat, if the meat is handled with gloves and everything 

and it’s cooked completely, that E.Coli is going to get killed by the 

heat, you know. 

But that doesn’t mean that you want to put people at risk by 

having a lot of E.Coli in the meat, because not everybody is going 

to be able to keep to that standard. So I think of it as a shared 

responsibility. I know that consumer education is an extremely important part of what we want to accomplish and USDA wants to 

accomplish, but that alone is not going to be sufficient. 


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And I think that you are raising a question, which is important, 

which is when we talk about food safety, are we dancing on the 

head of the pin. Are we talking about real things that can be done 

that can make meaningful improvements in food safety? And I 

think if you look back to say the PCA thing that just happened and 

the fact that you had a facility that was very—— 

Mr. KINGSTON. It was criminal actually more than process. 

Dr. SHARFSTEIN. And, but the fact that you had hundreds of companies that were purchasing from that facility and not really aware 

of the conditions there, it suggests that there are things that could 

be done, processes that can be put in place, that can make the food 

supply a lot safer. It won’t be perfectly safe at the end of the day, 

and I don’t think perfection can be expected in this. But meaningful improvements that will reduce those numbers are what we are 

trying to find. 

Mr. KINGSTON. Yeah. No. I am excited about it, but I also feel 

that FDA in the face of political pressure still has to be the adult 

in the room and say, you know, the food system is right here now, 

and we want to take it here, which means we are going to own up 

to this 300,000 number. We are going to reduce it to 150,000; and, 

I am like you. I don’t want any deaths, whether they are food 

borne, you know, from the household issues or elsewhere. 

Dr. SHARFSTEIN. So, your point is extremely well taken. I think 

the metrics and outcome have got to be a part of what we are 

doing. 

Ms. DELAURO. Mr. Farr. 

Mr. FARR. Thank you very much. I think the certification process 

really needs to be implemented, because I represent the most productive agricultural valley, maybe in the world, the Salinas Valley. 

And it was the center for the E.Coli breakout—not the Salinas Valley, but a valley near there—and it was isolated to one farm. 

That E.Coli spinach recall had all kinds of unintended consequences for growers. One was that it was voluntary, so about a 

hundred millions dollars was lost in our county and not reimbursed 

in any way by any insurance. If it had been a taking, of course, 

it would have been some reimbursement for that. 

I want to compliment you, because I have seen your budget. You 

are going to spend some money on it to improve risk communication during a food safety event so that the public can respond 

promptly to the FDA alerts and protect themselves from harm. I 

would like to make sure that you also include that to study the 

ways of improving the communication so that it’s not just a scare 

tactic, because that’s where I think, you know, the analogy given, 

‘‘if an airplane goes down people don’t stop flying.’’ 

But with this, the unintended consequences of just saying ‘‘Don’t 

eat spinach,’’ is to this day, leafy greens have never reached what 

they were at that point. And you know Mexico didn’t say we’re not 

going to buy any lettuce from the United States. The E.Coli was 

in spinach. But I think it is really important for the government 

in its ability to inform a constituency. I have seen this with fires 

this summer where—nothing to do with your agency—but law enforcement demanded that people leave, and they had all the information they needed, because they’d look on the Internet. And 

they’d say, ‘‘Why should I leave my house?’’ 


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You know, ‘‘The fire is 10 miles away. It is burning at a half a 

mile a day. It is not going to be here for days. I am not going to 

leave.’’ And I think there is a whole new communication system out 

there that government hasn’t really taken into consideration. It’s 

the Internet, and Facebook, and so on. So I hope with this money 

that you’re going to really work on what I call risk communication 

to make sure that the communicators think about what they’re saying the consequences of that will be. 

RECOVERY OF INDUSTRY

Dr. SHARFSTEIN. Let me respond in two ways. The first is I think 

that the response to these outbreaks is under-prioritized recovery. 

Recovery is a really important goal of food safety system, and I 

mean by recover, I mean recovery of the industry. And even from 

the beginning of an outbreak, that has to be a consideration; and, 

I’ll give you a specific example of my short time with FDA how 

that’s played out. 

From the moment that we were engaged with the pistachio industry, we called in the leaders of the industry and talked to them, 

and asked them to see whether they would be willing to set up a 

website right away that would be the products that were not associated with the farm that had the problems. And they were maybe 

a little surprised to hear from us, but very interested; and they immediately set that up. 

And we’ve had, you know, many, many hundred thousand—I 

don’t know exactly how many—hits through our website. We link 

to it from the FDA website; the industry, you know, wanting to 

make clear right from the beginning which products were not associated with this particular farm that was the problem. 

And, I think that’s a very small step, but I think we have to 

think about from the beginning of these how we narrow the advice, 

and then what we do to permit confidence in the food, because people have to eat. And there are so many healthy foods out there, 

that’s just extremely important. 

RISK COMMUNICATION

On your point about risk communication I can tell you as a 

former local health officer in Baltimore that is the most challenging 

part of the job. 

Mr. FARR. What you learned as a doctor, the first rule is don’t 

alarm the patient? 

Dr. SHARFSTEIN. Well, I think you’re right. We don’t want to 

alarm people. On the other hand, we want to give people the risk 

information that they need to protect them. 

Mr. FARR. Exactly, but we have to be smart about it. 

Dr. SHARFSTEIN. And what we’re going to use the money for is 

in part to work with some researchers to hear how people are hearing the messages, because you can say the message and you can 

think you are getting it across; and people aren’t hearing. 

Ms. DELAURO. Thank you. We also want to prevent them and not 

react to them continuously. Mr. Latham. 

Mr. LATHAM. Thank you Madam Chairman. 

And I know we have votes on the floor here so I’m going to try 

to be brief. First of all, I want to associate myself with the previous 


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round, Mr. Farr’s question about the disparity of inspections for express carriers, and that’s a major issue; and, we need answers on 

that. 

Talking about imported products; and, Ms. Emerson wanted me 

to ask some questions also about how the FDA proposals to rely on 

certification in order to obtain assurances that products comply 

with food safety standards, the certification, how would that work? 

Would it be used on domestic products only or on imports, or only 

for imports? 

DOMESTIC PRODUCTS

Dr. SHARFSTEIN. So we are putting together the pieces of how we 

would approach this, and I will start with domestic products. I 

think the understanding is that we would have an integrated local, 

state-federal system where we would be working very closely with 

the states, localities, and there would be inspection through that 

system, not through third-party certification. 

For imports, it’s a different situation, and I think the best position you’d be in is where the country is doing such a credible job 

of inspections that you can rely on the country certification. 

Mr. LATHAM. How do you assure that? I think that’s the question. I think that’s the question. How do you assure that the foreign country is credible. You’ve got people over the monitoring all 

the time? Or are there certification processes? 

Dr. SHARFSTEIN. That hasn’t started at FDA yet. USDA has the 

whole system of certification. We could probably learn a lot from 

how they do it, but we would anticipate that not every country is 

going to qualify for that, so then you’ve got to shift gears a little 

bit and you’ve got to say: ‘‘All right, if the country is not going to 

do it, could the country as a whole?’’ 

THIRD-PARTY CERTIFICATION

Maybe the country’s oversight of this particular crop will be sufficient. We’d have to create standards for that; and, if that’s not sufficient, maybe there’s a third-party certification process, internationally, like they are trying to do with shrimp that could have 

credibility. And with each of the steps you want to be checking 

more and more so that, you know, if the country standard is the 

best standard to have, you would have a certain level of checking. 

But as you move towards other levels of standards that, you 

know, you are going to have enough confidence in, but you were 

going to have that confidence because you are going to be checking 

more and more, so we hope to be sharing. And I think, you know, 

an approach to this that will make sense and be able to answer 

some of those questions. In part, it is going to depend on whether 

and what kind of food safety legislation passes, because it gives us 

different authorities in that respect. 

Mr. LATHAM. Now you’ve got a proposal that products that fulfill 

additional guarantees to exclude intentional contamination bioterrorism risks, maybe eligible for fast-track processing at the border. 

Are you going to have rules? Are you going to have guidance for 

the companies? Do you have any idea where that’s going to come 

down? 


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Dr. SHARFSTEIN. I think that partly is going to depend on what 

passes in Congress. But the principle there is the more assurance 

we have that something is safe based on the rules that pertain to 

where it’s made and who’s overseeing it there, then the quicker it 

will be able to get into the country. The less assurance we have depending on the system, then the more we are going to have to do 

at the border for those products. 

Mr. LATHAM. Do you expect to have fewer inspections under a 

system like that? 

Dr. SHARFSTEIN. I think that what we expect to have to be able 

to target whatever number of inspections we have as effectively as 

possible. So I don’t think that we are going to say. We’d like a system that doesn’t have to be that we are inspecting 50 percent of 

the food, because that would be enormously expensive and not even 

as effective as having a better prevention approach in other countries. 

Mr. LATHAM. Okay. I am going to stop there in the interest of 

time. I’ve got some questions for the record, but thank you, Madam 

Chairman. Thank you. 

Dr. SHARFSTEIN. Thank you. 

Ms. DELAURO. Thank you. 

I will encourage my colleagues to go to vote. I just want to lay 

out something that we can come back to, but we will do that. I will 

be back and I think many of those who can will come back as well 

for additional questions. This has to do with counterfeit and contaminated products from China. A ‘‘Reuters’’ news story: ‘‘China 

State Food and Drug Administration counted 329,613 cases of the 

distribution of unlicensed drugs and medical products in 2007.’’ Recent Op-Ed in the Asian section of the ‘‘Wall Street Journal,’’ as 

many as five million Chinese citizens work in the counterfeit market, which includes fake drugs, patent infringement and trademark 

infringement. 

While the Chinese government might not directly participate in 

drug counterfeiting, it certainly enables the practice at a minimum 

by looking the other way. Indeed, drug counterfeiting may be a significant part of the economy. The story also quoted a Chinese expert in counterfeiting who said: ‘‘Counterfeiting is now so huge in 

China that radical action would crash the economy over night and 

even destabilize a government or counterfeit factories and warehouses are often owned by local military and political grandees.’’ 

Five million people in China work at counterfeiting drugs; little 

enforcement by their government. What do you plan to do beyond— 

right now, as I understand, there are a couple of offices in China 

staffed by a few people in order to be able to safeguard the American people from dangerous drugs—Chinese drugs, drug ingredients and foods. 

I clearly will come back with that, but I also have here a list of, 

you know, January 2009 listing all of the various products that 

have been stopped coming in from China as something as unsafe 

and we’ve got in the first four months of 2009 such practices as 

what the Chinese government is doing. The FDA rejected 839 shipments of Chinese products including fish. 

Anyway, I have two minutes to go to vote, but I mean this is 

such a serious issue without any real infrastructure in place to deal 


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with it. Two percent of shrimp inspected, I mean, I think this is 

a crisis. I really do. And, today, 73 percent of people in this country 

are more fearful of the food they are eating in terms of food safety 

than they are in the war on terror, so I am going to ask you to address this when I get back. Thank you very much. 

Recess subject to the chair. Thank you. 

[Recess.] 

Ms. DELAURO. I want to get the permission, which I have, of the 

Ranking Member. You usually cannot start with just one person. 

I apologize. It was longer than anticipated. 

The hearing is called to order. I am not going to go through the 

commentary again, Dr. Sharfstein. This is on the counterfeit drugs, 

China. 

Dr. SHARFSTEIN. I think this is an extremely important issue and 

one that Dr. Hamburg feels particularly engaged in. I think she is 

very aware of the statistics like this that show the increase in imports over time and reflect the incredible change in the world over 

the last decade in how products are coming to the United States. 

COUNTERFEIT DRUGS

I think there are three separate issues. One is the counterfeit 

issue, which are drugs that are sort of purported to be a particular 

drug but are not that drug at all. That is very much an issue of 

global concern. 

The World Health Organization is very engaged in it and there 

is going to be a lot of activity globally on it. 

I think part of the solution to that one in comparison to the other 

two issues is that if we had a solid system for pedigree and tracking of drugs, then we know we are getting what we are getting. 

That is for that issue. 

SUPPLY CHAIN SAFETY

Then there is a second issue of for what we are getting, are there 

safety issues. You have the not counterfeit, meaning a drug that 

is not sort of fake but the actual drug that has originated from another country where there are issues in the supply chain. The obvious example would be Heparin. 

Ms. DELAURO. That is the thing that just came to my mind. 

HEPARIN

Dr. SHARFSTEIN. That is in the second category. The Heparin 

problem was not a counterfeit problem. It was a problem that the 

actual raw ingredient was contaminated, and you have a situation 

where many raw ingredients for many drugs—— 

Ms. DELAURO. That appears to be intentional, the contamination 

of Heparin. No? 

Dr. SHARFSTEIN. You have this issue of actual products that are 

legitimate products but may be unsafe because of problems in the 

supply chain. 

Ms. DELAURO. That requires a tracking system. 

Dr. SHARFSTEIN. I think the first issue, the counterfeit issue really is a solid tracking system, make sure you are getting the actual 


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drug you think you are getting in the sense that this is the company’s drug. It is not someone purporting to be the company’s drug. 

The second issue is more complex because even a tracking system, you could be getting the drug you think you are getting but 

that drug can be contaminated in some way, and trying to figure 

out how to establish a system that is going to prevent that is much 

more complex. 

Then there is the issue of foods, where you have hundreds of 

thousands of companies selling foods into the United States from 

different directions, all sorts of different foods, and it is not a closed 

system like the drug supply is. 

Each of those are major challenges. I think this is going to be— 

you are putting your finger on one of the biggest challenges facing 

the food and drug markets, the biggest challenges facing the FDA, 

it is going to require a combination of approaches, but we are very 

much aware this is an important issue. 

The approaches include, I think, responsibility at a lot of different levels. We have to hold the Government responsible in part, 

the Chinese Government, but in addition, the people importing the 

product have to be responsible. The companies that are—it is their 

supply chain, they have to be responsible. 

There are major public health issues involved in this. There 

would be obvious public health issues like the food being unsafe or 

the drugs being unsafe, but then there are other public health 

issues. 

The market for counterfeit drugs could mean a lot of people not 

getting treated with the right drugs, or for example, when you are 

dealing with anti-microbial drugs, like tuberculosis drugs, if somebody is making a poor quality tuberculosis drug, it is not even just 

that the patient does not get treated but that tuberculosis could become resistant. 

Ms. DELAURO. Right, and that is a real problem. 

Dr. SHARFSTEIN. That could swing back and hit the whole world. 

You have a series of overlapping challenges with imports that are 

going to be very important to address. 

Ms. DELAURO. This is January 2009. Coca, melamine. Mixed 

mushroom, filthy. Frozen cat fish nuggets, Chloramphenicol. Chocolate candy, dark chocolate, all melamine. Dried mushrooms, filthy. 

Dried food, candy glaze, honey. Filthy. 

It is staggering. This was stopped, fortunately. It is a large plate 

with a lot of things on it, but I think—vermicelli, filthy. 

PUBLIC HEALTH

Dr. SHARFSTEIN. I take that personally. 

Ms. DELAURO. Right, I take that very, very personally. Frozen 

white shrimp, unsafe animal drugs, fermented shrimp sauce. 

Your business and my business is not trade. This is about the 

public health. We need to be able to rely on you to put the mechanisms in place. This is something that we will continue to talk 

about as you all move forward. 

Mr. Kingston. 


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CIGARETTES

Mr. KINGSTON. Thanks, Rosa. Doctor, on the regulation of cigarettes, nicotine is carcinogenic, yes or no? What is carcinogenic in 

cigarettes? What ingredients? 

Dr. SHARFSTEIN. Which ingredients? I think there are a number 

of them. I think there are more than 100 carcinogenic ingredients 

in cigarettes. 

Mr. KINGSTON. Are you not in kind of an oddball philosophical 

position of having to come up with acceptable regulations of carcinogens? 

Dr. SHARFSTEIN. You mean—— 

Mr. KINGSTON. Let us just say that was in cereal. You would not 

allow the cereal, right? 

Dr. SHARFSTEIN. I think I understand what you are saying, that 

if the legislation that is moving forward now were to pass and FDA 

were to have regulatory authority over tobacco, would there be 

kind of a weird situation for FDA given that cigarettes are harmful, to regulate them. 

I think it is a fair question to ask. I think the question that you 

have to ask with this is sort of the same question you have to ask 

with any kind of product or regulatory decision, which is do the 

benefits of doing it outweigh the risks. 

I think the benefits of FDA regulation on tobacco could be quite 

considerable in terms of the public health. Tobacco is such a dangerous product and so unregulated right now. 

At the same time, there are potential risks. One of the risks is 

that people may perceive why is FDA permitting something that is 

unsafe, as you put it. 

I think on balance, there is no question in my mind that the benefits would outweigh the risks. 

Mr. KINGSTON. What would you be able to do that would be different from what is going on now? 

Dr. SHARFSTEIN. Under the tobacco legislation? 

Mr. KINGSTON. Yes. 

Dr. SHARFSTEIN. I think there is authority there that relates to 

the marketing of tobacco products as well as the composition and 

performance standards that would be for the manufacturing of tobacco products. 

Mr. KINGSTON. What would you do different in the advertising? 

Dr. SHARFSTEIN. We do not have authority over it and it is not 

something the agency has really thought of, but it would be—the 

one thing I would say is part of the legislation does implement the 

1996 rules, which was proposed and does have some advertising related provisions in it. 

I do not know if I could tell you all of them exactly. If you went 

back to that, you could see some of the things that the bill—— 

Mr. KINGSTON. Maybe if you could give me something for the 

record. I would love to know what you would do different in advertising and then what you would do different in the regulatory 

structure, and the big question that everybody hates to ask, you 

know, what is the safe level of nicotine. 


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Are you going to tell me I can go to three cigarettes a day and 

that is better than ten? Once you have that FDA stamp on there, 

you are telling a whole bunch of kids, hey, the FDA approves it. 

[The information follows:] 

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) 

amends the Food, Drug, and Cosmetic Act (FDCA) to give FDA authority over tobacco advertising in several respects, including, principally: 

• Under FDCA Section 906(d), FDA may impose restrictions on the advertising 

and promotion of a tobacco product as appropriate to protect the public health. 

• Under FDCA Section 903, a tobacco product is misbranded: (1) if its advertising 

is false or misleading in any respect (Section 903(a)(7)(A)); (2) if it is sold or 

distributed in violation of regulations prescribed under Section 906(d) (Section 

903(a)(7)(B)); or (3) unless its advertising and other descriptive printed material 

includes certain information (Section 903(a)(8)). 

• FDCA Section 911 contains several provisions relating to advertising for modified risk tobacco products, which give FDA some administrative responsibilities, 

rulemaking authority, and enforcement authority. 

• Section 201 of the Tobacco Control Act directed FDA to reissue final regulations 

issued in 1996 that restrict access and certain marketing practices, including 

certain advertising practices, to protect children and adolescents. These regulations, 21 CFR Part 1140, were reissued on March 19, 2010 (75 FR 13225). 

• Section 201 of the Tobacco Control Act amends the Federal Cigarette Labeling 

and Advertising Act and Section 204 amends the Comprehensive Smokeless Tobacco Health Education Act of 1986 to give FDA administrative responsibilities, 

rulemaking authority, and enforcement authority over the statutory health 

warnings on cigarette and smokeless tobacco packages and in advertisements. 

Dr. SHARFSTEIN. I could tell you that three cigarettes a day is 

probably better than ten because there is a dose response, the more 

people smoke, the more dangerous it is for them. 

I do hear your point. I know it is something the bill tries to address. I think it is something that has to be taken into account as 

you move forward so people do not get the idea that a product is 

safe just because the FDA regulates it. 

FDA regulates other things that may not be so safe also, and has 

to deal with that same balance. 

Mr. KINGSTON. Do you regulate things that have carcinogens in 

them? 

TANNING BEDS

Dr. SHARFSTEIN. Yes. For example, tanning beds would be an example, and can promote skin cancer. There are actually a lot of 

drugs that can cause cancer. 

Mr. KINGSTON. Let me ask you this, another philosophical question. Do you think FDA should regulate cigarettes? 

Dr. SHARFSTEIN. Yes. 

CIGARETTES

Mr. KINGSTON. Do you think cigarettes are bad for you? 

Dr. SHARFSTEIN. Yes. 

Mr. KINGSTON. Do you feel—I am going to kind of assume you 

do feel a little bit of queasiness in that there is an endorsement 

side to this; correct? 

Dr. SHARFSTEIN. I think you have to look at it as a benefit of regulation versus the risk, just like any kind of balance. 

Mr. KINGSTON. You have an opportunity to control it a little better and kind of accept, you know, you cannot outlaw tobacco smokVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00111 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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ing but FDA involvement might come up with better results, philosophically. 

As I understand it, menthol cigarettes are exempted. Is that correct or am I wrong on that? 

Dr. SHARFSTEIN. I think the current version of the bill prohibits 

certain flavorants right off the bat. 

Mr. KINGSTON. I think they are exempted. 

Dr. SHARFSTEIN. What menthol is—menthol is not listed as one 

that by statute is prohibited, but the FDA would have authority to 

take action on menthol under the current version of the bill. 

Mr. KINGSTON. The menthol language, you think is fine and acceptable, or would that be something you would not wish necessarily was in there? 

Dr. SHARFSTEIN. I think the menthol language is fine. I think the 

President has made it clear that he supports the legislation. 

TOMATOES

Mr. KINGSTON. I want to get back to Mr. Farr’s question earlier 

in terms of the health benefits of eating peanuts, spinach or tomatoes. When the FDA sounded the alarm on those three products, 

there were a lot of people who were unable to buy these products 

or they could buy them but basically, it was very risky. 

Dr. SHARFSTEIN. They were told not to eat them in some cases. 

Mr. KINGSTON. Mr. Farr’s analogy, and I think it is a good one, 

it is almost like there is a plane crash and we have gone out and 

told people do not fly, planes are unsafe. 

That absolutely was not the case with many of the products that 

are out there. You had said to him that is where the trace back 

becomes important, so you do not just say okay, nobody eat tomatoes for the next three months until we get to the bottom of this, 

but you could pinpoint what farm or what production shop or whatever. 

There would be a data bank of information. Who keeps that information and for how long and who would have access to it? 

Dr. SHARFSTEIN. That is an excellent question. I think right now, 

FDA is working on guidance for the industry on how to keep information. Ideal would be that the companies would keep the information. 

Mr. KINGSTON. I just want to interrupt real quick. I may have 

misunderstood you but I thought you said to him that the stakeholders would not be in the room, that you would do this kind of 

by yourself or something. 

Dr. SHARFSTEIN. No, I do not believe that at all. 

Mr. KINGSTON. There was some statement. I want to make sure 

I have a clarification. 

Dr. SHARFSTEIN. I think that working with industry in these— 

Mr. KINGSTON. As you did. I think you pointed out with pistachios, you did bring in—that was a different model than these 

other commodities. 

Dr. SHARFSTEIN. I started the day the pistachio thing happened. 

It has been said no matter how long I last at the agency, whether 

it is a month or ten years, my good-bye present is going to be a 

bag of pistachios. 


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That is where we started and I thought it was very important 

to reach out to the industry. 

The other area in food that we have dealt with is alfalfa sprouts. 

That was very challenging. We had extensive conversations with 

industry from the beginning. It is only at the point where we realized it looked like 70 percent of the seeds could potentially be involved, the industry understood the predicament. 

It is challenging. When I was the health commissioner in Baltimore, you get called in the middle of the night. There are 100 people that are sick in the hospital. You show up. 

This is a true story. I went to the hospital. They said there had 

been a wedding and someone had driven a pig down from New 

York, from New York to Baltimore. People had eaten it after it had 

been sort of at lukewarm temperature. 

Clearly, you knew exactly what made people sick. Now you have 

the situation where you know probably thousands of people have 

gotten sick and you do not know the cause. It is a real challenge. 

I think that when we are in that situation, we want to protect 

people, but we do not want to scare people and destroy industries 

that are very important to the United States. 

I think we have been trying to do this a lot more, or I have been 

trying. It is one of my goals since I have been there, to get everybody who is engaged and knows information to the table, figure out 

how we can best make a tough judgment under the circumstances 

to protect people and balance that against the other issues that are 

involved. 

It may be that what we did with pistachios is we made a pretty 

broad announcement and then narrowed it very quickly, and the 

same thing with alfalfa sprouts, a pretty broad announcement but 

we told people we think we are days away from getting it more 

narrow, and we were days away, and we were able to narrow it. 

It was by working in large part with the industry that we were 

able to figure that out. 

INDUSTRY

I met with the industry several times already. They have been 

very open to it, even on peanuts. We are working with them to try 

to get the messages out that they are interested in getting to their 

growers. They have been incredibly supportive of the FDA doing 

more. 

I think there is a lot to be done in concert with industry that is 

going to make the food supply safer. 

Mr. KINGSTON. Thank you. 

Ms. DELAURO. I think it is true about industry. We were both 

here when the western growers told us that what we needed were 

mandatory enforceable standards because they were going out of 

business. Spinach has not come back to what it was. Tomatoes, lettuce, peppers, the whole business. 

I think industry is very, very much interested in making sure 

that the product is safe and there is an opportunity to work with 

them. 


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USER FEES

I want to ask about the food registration and inspector user fees. 

There are a few references in the budget document which you estimate in terms of food registration, an inspector user fee, $75 million in 2010. 

At one point, the document says the fee would allow FDA to collect fees to register food facilities and conduct safety and good manufacturing practices, inspections of food manufacturing and processing facilities. 

How would the fee be assessed? Are you proposing a single fee 

for registration, that is conducting the safety, the good management practices? This fee would fund inspections or are you planning to charge both a registration fee and a fee for the cost of inspections? 

If you are planning a fee for inspections, would that be assessed 

on a per inspection basis or would it be a general fee paid by the 

facility? 

Frankly, I would be concerned about the potential for a conflict 

of interest in a per inspection fee. 

Dr. SHARFSTEIN. I understand that. I am going to ask Patrick to 

tell me whether I am wrong on this. I may just have him answer 

that question. I know there is a registration fee and I think there 

is a re-inspection fee, which is a separate fee. 

Ms. DELAURO. That is a different issue. That requires legislation. 

Dr. SHARFSTEIN. Right. I think this also would require legislation, the food registration fee. 

Ms. DELAURO. That is right. 

Dr. SHARFSTEIN. I know at a minimum it would be a fee upon 

registration. I do not know whether it is contemplated, I have not 

heard, that it would be a per inspection fee. 

Mr. MCGAREY. I have not heard any discussions on it being a per 

inspection fee. 

Ms. DELAURO. It would be important to know. If you could get 

back to us on that. That is something we would just like to get 

some clarity on. 

[The information follows:] 

FDA USER FEES

FDA’s FY 2010 budget includes $75,000,000 for user fees to register food facilities 

and conduct safety and good manufacturing practices inspections of facilities that 

manufacture and process foods that Americans consume. The Food Registration and 

Inspection User Fees recommended in the FY 2010 budget would be paid annually 

by each registered food facility, whether the facility is inspected that year or not. 

FDA will use the fees to pay for inspections of food facilities and other food safety 

activities that FDA conducts. 

Dr. SHARFSTEIN. Okay. No problem. 

Mr. KINGSTON. Rosa, would you mind yielding? 

Ms. DELAURO. Not at all. Go ahead. 

GENERIC DRUGS

Mr. KINGSTON. I think this Committee really is philosophically in 

support of generic drugs, and what we might be interested in from 

you is what can we do to accelerate them getting to market. There 

are a lot of obstacles that are out there. We would not mind strayVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00114 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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ing into the authorization territory. Appropriators do not authorize 

unless you have everybody who wants to authorize, have 51 percent agree. 

I think we would be interested in hearing from you on suggestions to get them out there. 

Dr. SHARFSTEIN. Yes. 

I think there is obviously a goal of getting the user fee program 

off the ground. I met with the generic drug industry. They seem 

quite open to the idea of this. I think if everybody who is engaged 

in it seems supportive of it, you have at least the basis for it actually happening. 

I would be pretty optimistic just going in that it could be worked 

out that way, but I do think if that path does not pan out, we are 

going to need more resources to be able to get more generics to the 

market. 

Ms. DELAURO. The control measures for all levels of food production and processing, the budget again says ‘‘FDA will improve its 

ability to protect American consumers, strengthen safety and secure the supply chain by working with domestic and foreign industry to develop new control measures for all levels of food production 

and processing. 

‘‘FDA will also verify that these control measures are effective 

when implemented.’’ 

This ties in with what we were talking about before in terms of 

the imports. What exactly are these control measures? Will they be 

enforced, and if so, how? 

Further on control measures, I have two more specific questions 

on this and your views on moving to an equivalency system for 

FDA regulated food imports. 

My understanding is this was proposed during the Clinton Administration but never implemented. While I believe that there are 

gaping holes in how FSIS has administered equivalency, I am not 

using that as the standard. 

A properly administered equivalency system can be an important 

help for protection. 

Second, what about enforceable HACCP sanitation and pathogen 

standards? 

CONTROL MEASURES

Dr. SHARFSTEIN. To your first question about control measures. 

Ms. DELAURO. What are the control measures; right. 

Dr. SHARFSTEIN. The big picture is we really need a new food 

safety system that is premised on prevention, and in order to get 

that, and what we have heard very clearly from industry and consumer groups and you and others and all the experts we have consulted is we need clear regulations that establish the basic approach to prevention, that include things like performance standards where they are appropriate. 

That is something that we hope to get out of the legislation in 

the Commerce Committee. If we do not get that, we will see what 

we can do under the current law. 

That is what is needed. The entire system is probably not going 

to be put into place by the time we meet again next year, but we 

want to see a lot of progress towards that. We want to see many 


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different things moving forward that are going to do that and over 

the next several years, we want to see that system put into place. 

On the question of equivalency, are you talking about third party 

certification equivalency or are you talking about international 

equivalency? 

Ms. DELAURO. I am talking international, government to government. 

Dr. SHARFSTEIN. Government to government. I think something 

like that has got to be part of the import system. It is inconceivable 

that FDA could be inspecting 200,000 facilities. There has to be 

some other way to approach it. 

Equivalency is going to be something that we will have to look 

at, the strengths and weaknesses of the USDA system will be 

something we will have to take into account in doing that. 

EQUIVALENCY

I think we are open to the idea of equivalency overall, and then 

equivalency for particular products. If a particular country import 

a lot of a particular food or something, that particular food is done 

well and we know it is done well, and we have confidence that they 

can oversee it, and that is good enough. 

The key in my mind is that we have different tools to balance 

it. The more confidence we have in that system, the easier it is for 

the products to come in, the less confidence maybe the more assurance we need from that system, then our approach at the border 

can change. 

We are not saying that everything is exactly the same. We have 

the ability to kind of modulate what our response is at the border 

based on our level of confidence about what is going on overseas, 

and in the end, those two things have to add up to an acceptable 

level of confidence or else we cannot import it. 

HACCP

That is what we need to get to. 

Ms. DELAURO. And HACCP? 

Dr. SHARFSTEIN. We are in favor of HACCP. It has to be adapted 

to the products appropriately. One good thing about HACCP is it 

gives a lot of flexibility to the companies to innovate as long as 

they are hitting their safety targets. 

You do not want to lock people into an old way of doing business, 

but you want to hold them accountable. I think what you see in the 

wake of some of the food safety problems are businesses and industries really stepping forward and doing an awful lot. 

I think it is just critically important if you think about how much 

testing is going on in the private sector, we want that to be as high 

quality as possible. I really do believe that the companies, particularly the big companies, have such an incredible interest in the safe 

food supply that they really are allies in how we move forward. 

Ms. DELAURO. Mr. Kingston, would you mind if I ask one more 

question? 

Mr. KINGSTON. No, not at all. 

Ms. DELAURO. I will just ask this one and then turn to Mr. Kingston and then hopefully we can try to wrap up. 


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STATE INSPECTIONS

This is about the review of state inspections of food facilities. 

Budget again will allow ‘‘FDA to expand state capacity for risk 

based inspections by increasing the number of cooperative agreements and partnerships with states.’’ 

Peanut Corporation of America is the case in point here. Just 

having state inspections is not enough if FDA does not do anything 

to ensure that the state inspections are competent and thorough. 

We have a news story that ran on Monday that says ‘‘The FDA 

told several minority members of the Energy and Commerce Committee that it did not even know if it had done any reviews at all 

in 11 states in 2007 and 2008, including Texas and Georgia, where 

salmonella was found in peanut plants this year.’’ 

The story said that an FDA official wrote to those members and 

said the recent salmonella outbreak, and I quote, ‘‘Has highlighted 

limitations in our current approach and has prompted internal discussions on potential enhancements to the audit program.’’ 

I am a little tired of seeming to look at failures and think about 

improvements after people die. That is not a standard I think we 

ought to adhere to here. 

The stories have identified numerous holes in the state inspection system operated by FDA. What is particularly troublesome is 

that the gaps in the system were identified in 2000 by the IG and 

little has been done to address them. 

What specifically is FDA doing now to improve the quality of 

state inspections? What are you going to do in 2010? What do you 

believe is the purpose of these contracts? How should FDA oversee 

the work of the states and are our states now required to report 

their findings to the FDA? 

Dr. SHARFSTEIN. Let me take that on in a couple of ways and I 

might ask Mike Chappell from the Office of Regulatory Affairs to 

answer some of those, give his perspective. 

I think the approach—I think your point is very well taken that 

this is not about modest improvements in the system. This is about 

really changing the system. 

Ms. DELAURO. I would just say this, I believe we do not have all 

the resources to do what we need to do. 

Dr. SHARFSTEIN. But even with that, I think the right question 

is not how we are going to audit a little bit better, that is not the 

right question. It is how are we going to really integrate the Federal, state and local food safety systems. 

There was a very good report that was done for the Robert Wood 

Johnson Foundation by Mike Taylor at G.W. that I would definitely 

commend to you. It is something that the FDA has been engaged 

in and FDA has been meeting with the states around food safety, 

David Acheson and Steve Sunlof are both here. 

The idea is not to think of the states as contractors any more. 

I think there is $15 million in this budget to start this transformation, but to really be a partner with the states. 

STATE PARTNERSHIPS

FDA really does not have the kind of training capacity that it 

needs, that we would be at a point that when the state goes out, 


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we feel like it is FDA going out, and we have confidence in their 

inspections. We have confidence in their labs. That is the goal. 

I was just at a meeting where a business said I know we hear 

there are not enough inspections, but we could have a week where 

a Monday, it is the Federal inspector. On Tuesday, it is the state 

inspector. On Wednesday, it is the local inspector. Sometimes, they 

are all the same person. They just put on a different hat and they 

are filling out different forms. Does that make any sense at all. 

How can you say that makes sense. 

In order to jump to that system that is envisioned in the Robert 

Wood Johnson report, there is going to be an up front cost of developing the capacity to really retrain the states, invest in the states. 

I can tell you this for Maryland, this is not an area—the states 

are having economic problems. This is an area where a Federal 

partnership that comes with money, I think, would be very much 

appreciated because then it would give them a big incentive also 

to participate and develop the capacity we want to see in the 

states. 

AUDITS

I think there is an issue with the audits under the current system, but I think the right question is not are we going to get 60/ 

70/80 percent of the states audited, it is are we going to really 

change our relationship with the states, change the system, so we 

are able to genuinely feel like they are partners and not sort of 

hired hands to deal with inspections. 

Mr. CHAPPELL. I think that is fair. 

Ms. DELAURO. You have to identify yourself. 

Mr. CHAPPELL. I am Mike Chappell. I am the acting associate 

commissioner for Regulatory Affairs. 

I think as Dr. Sharfstein said, we are really going to approach 

it a little bit differently. Frankly, we really have not put the resources into what was our typical audit program. We are looking 

at it totally different, rather than trying to audit inspectors per se, 

look more at state programs holistically. Integrate training. Integrate audits, the whole process. 

I think we are moving forward in that direction, and certainly in 

the manufactured food standards, where we are trying to look at 

standards for programs rather than auditing individual investigators or states. 

Ms. DELAURO. Thank you. Mr. Kingston 

Mr. KINGSTON. I do not know if the FDA has this model, but 

with USDA, with many processing plants, you can be inspected by 

state inspectors or a USDA inspector, but you can actually choose 

which one you want. You do not choose the easier one necessarily. 

There is some reason that some prefer Fed and some prefer state. 

Have you looked at that kind of model to stop that Monday, 

Tuesday, Wednesday, which inspector is going to walk in the door 

and what hat is going to be on his head? 

Dr. SHARFSTEIN. I think we should look at that model. I think 

we are in the process of setting up and moving forward, particularly in fiscal year 2010, a system like this, and I think that is very 

fair. 


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Mr. KINGSTON. There is a reason that some prefer state and 

some prefer USDA, and it may be because of interstate commerce 

or something, one checks more boxes on the list. 

It would appear that you do not have to re-invent the wheel because there is something out there that could be helpful. 

Rosa, I am actually finished, unless you say something that 

peaks my interest. 

[Laughter.] 

Ms. DELAURO. Then just interrupt, Jack. 

We are going to have votes within the next 15 minutes. I would 

like to try to get in the last couple of questions and I know you 

have to go to the other side or maybe to the dark side. I am sorry. 

I had to say that. 

OFF LABEL MARKETING

Off label marketing. This is a guidance issue that at the end of 

the Bush Administration, one week before it ended, issued guidance to facilitate off label promotion of drugs, medical devices, by 

drug and medical device companies. 

It allowed the drug companies to distribute reprints of medical 

journal articles on off label use of products with only minimal guidance on the quality of the studies and the journals themselves. 

A news story reported that Bush/FDA issued new guidance over 

the objections of Bush’s Department of Veterans’ Affairs, which 

pays for drugs taken by its health system patients. 

‘‘We urge the FDA to withdraw the proposal. The VA wrote FDA 

last year. It will not improve drug safety. It could very well result 

in a decline in drug safety.’’ 

Among other things, the VA said ‘‘Second rate studies published 

in journals with questionable peer review processes will be used to 

convince physicians to use drugs for an ever-increasing number of 

unapproved uses.’’ 

What are your views on the policy and will you move to revise 

it? 

Dr. SHARFSTEIN. Thank you for asking that question. Let me 

start by backing up a step. FDA does not regulate the practice of 

medicine and physicians are free to prescribe drugs for unapproved 

uses generally speaking. 

As a physician, I have prescribed drugs for unapproved uses and 

particularly as a pediatrician, because there are a lot of drugs that 

are not approved in kids, and it is really your only option. 

That problem is being addressed and thanks in large part to 

Congress, over time, that will be addressed. It is important to the 

practice of medicine that the physicians have that capacity. 

At the same time, when there is promotion of unapproved uses 

that is excessive, you have the potential problem that the particular uses may not be actually safe and effective because they 

have not been reviewed by FDA, and you also have the fact that 

companies may have less of an incentive to ever seek approval if 

they can go ahead and promote it without approval. 

As a result, I think you have to draw the difference between the 

use of medicines for unapproved uses on the one hand and the promotion of medicines for unapproved uses on the other. 


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I am aware of the guidance that was issued. I think like many 

different things going on, it merits looking at. It is part of the bigger picture of how do you strike a balance with unapproved use 

that respects both the importance in many cases of unapproved use 

but at the same time, not wanting to permit promotion that could 

have adverse health problems. 

Ms. DELAURO. You are going to address that issue? 

Dr. SHARFSTEIN. Yes, the issue of unapproved use is something 

that is very much on our minds. 

FOOD SAFETY

Ms. DELAURO. I will not go through all the commentary here. I 

think you have heard me say before there is no one official in FDA 

who is responsible for overseeing food safety, that the functions are 

spread out and scattered across it, OBM and ORA, toxicological research, et cetera. 

It has been suggested that the President could administratively 

create a new position of FDA deputy commissioner to the Secretary 

for Food Safety, directly accountable to the Secretary. 

This would create within the FDA a virtual food safety agency, 

if you will, and give the person authority over the food safety effort. 

I do not know what your thoughts are about that, which I would 

like to get. My question is would you move to support legislation 

that would get us moving toward consolidating food safety functions of FDA? 

I am going to pose my question this way because I think you 

probably know where I am going with this question. 

You may have to hedge your response because of the food working group and in any case, I do want your views on a single food 

agency, and is the Administration with regard to FDA opposed to 

a single food agency? 

Dr. SHARFSTEIN. Sure. To the first part about a position within 

FDA, I would split your statement into two parts. One is does it 

make sense to have somebody in charge of all food activities at 

FDA, and I would say that is a suggestion we are taking very seriously at this point, and we will be happy to update the Subcommittee on where that goes. I definitely understand that perspective. 

Where that person reports is the other half, and you mentioned 

reporting to the Secretary. I will just tell you personally, that does 

not make sense to me. If it is within FDA, it should report to the 

FDA Commissioner, as to maintain a good management structure 

and not create a lot of confusion, people have to know who they are 

reporting to. 

I think both Dr. Hamburg and I are extremely committed to food 

safety. Both of us have experience as local health officers managing 

outbreaks. I think we are going to be very focused on it and I think 

we will be able, as you can tell from the level of interest in this 

discussion, this is a very high priority for us. 

SINGLE FOOD AGENCY

As far as the single food safety agency, the big picture is I am 

not aware the Obama Administration has a position on this at this 

point. 


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My view is this is an opportunity for major progress on food safety in the United States as we switch to a prevention oriented system, and there is a lot of ground that we can gain very quickly if 

we are really focused on moving forward, and that is the right 

thing to be doing now. 

The longer term discussion on how best to organize things, I 

think that is something Dr. Hamburg and I are going to be willing 

to engage in, but without sort of a pre-conceived notion of what the 

right thing to do is. 

Right now, we think it is very important for FDA to get these 

resources and to get the authority and then to make a difference 

and create a better system. 

Ms. DELAURO. I appreciate that. I also would just comment, I 

still think that getting to where we need to go with regard to food 

safety means food safety out of FDA and the two agencies within 

HHS, as I have suggested and others, seems to be a good idea as 

well. 

MEDICAL PRODUCT INSPECTIONS

Quickly, it looks as if the $12.2 million for medical product inspections both domestic and foreign seems low. It seems to me to 

be very low in terms of your budget. 

I think it was Dr. Woodcock who testified last year at Energy 

and Commerce that it would cost an estimated $225 million to inspect foreign drug plants as frequently as U.S. plants are inspected. 

This seems very, very similar to the past here. As you begin to 

take a look at the problems here, are you open to advising us on 

the redirection here? 

Am I wrong that in terms of this changing what we deal with 

in terms of inspection of drugs, both domestically, and medical 

products, both domestically and foreign, does that seem low to you, 

$12.2 million? 

Dr. SHARFSTEIN. It is hard for me to answer that question in 

terms of whether it seems low or not. I think there is a lot of work 

that has to be done internationally, and that work may require 

more resources for FDA than is in this budget over time. 

I totally accept that premise. I think it cannot be a model that 

every country sends inspectors to everyone else’s plants. There has 

to be a better system of oversight where we have confidence in 

plants that maybe we ourselves have not inspected. 

I think that is why FDA has started some cooperation with Europe and Australia to kind of split up the inspections. There are a 

whole bunch of things that I think Dr. Hamburg is going to be very 

interested in looking into in this regard. 

As we dig into it and we figure out—I will tell you one of the 

things from my perspective in the budget is that things are measured by what the increase is as opposed to where are we compared 

to the goal. 

I think that ultimately, we want to understand for imports what 

is the goal system we are getting to, what does it take to get there, 

both in terms of policy and resources. That, I think, is eventually 

how we will want to present the budget as well. 


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DIETARY SUPPLEMENTS

Ms. DELAURO. The last two questions, this has to do with dietary 

supplements as it deals with health risks of conventional hormone 

therapy, and when there were risks associated with the therapy, 

people started to look at natural alternatives, such as the dietary 

supplements. 

The products are heavily marketed to women at or around the 

age of menopause. The Dietary Supplement Act limits FDA’s authority over the supplements. You are responsible for the safety aspects of the products and what is the adequate oversight of these 

efforts. 

How are you going to move the agency to develop a very robust 

safety program for dietary supplements within the current structure? 

Dr. SHARFSTEIN. Excellent question. You may be aware that FDA 

recently was involved in a voluntary recall of the largest dietary 

supplement used for weight loss in the United States. 

That was the result of work within the agency and a lot of work 

from external doctors who were publishing papers and being concerned about what was happening to their patients. That product 

was able to be removed. It was a relatively rare side effect that was 

identified, but a very serious one, and one that had the product 

come off the market. 

The challenges to FDA include the fact that we are not told what 

is being sold, let alone reviewing for safety prior to marketing. 

Within the context of FDA’s role, I think we have the manufacturing standards that are being put into place and we have the required adverse event report, reporting for serious adverse events 

that is being put into place, and we have to make as best use of 

those as possible. 

I think we have to be prepared if we are identifying risks, that 

are really putting people at risk, to not be shy about talking about 

them. I think that is in the best interest of public health but it is 

also in the best interest of the industry, which I do not think wants 

to put its customers at risk. 

I think using the data that we get, hearing from doctors who are 

concerned, hearing from patients who have had problems. 

The other thing that I think is important that we can look at is 

when companies are making claims that are inappropriate, we can 

crack down on that right away. Even if we do not have good data 

on safety, if people are making claims and are leading people to believe they can get something treated without appropriate evidence, 

we can stop them from making those claims and that could be helpful on safety, even without doing a full safety review. 

Ms. DELAURO. That means there is going to have to be funding 

attached to that, and adequate funding. 

Dr. SHARFSTEIN. I think that is true and there is a good group 

within FDA and I think one of the things we will want to do is assess how that is compared to the need. I think this recent withdrawal demonstrates that FDA can do things. 

I would commend the health hazard evaluation on this particular 

product. It very clearly walked through the evidence and when you 


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see that kind of evidence, you can understand why the company 

looked at that and did the right thing. 

MEDICAL DEVICES

Ms. DELAURO. My last question, and we will submit questions for 

the record, this has to do with medical devices, and you review 

medical devices, thousands of them every year. 

Ninety-eight percent are cleared through the 510K process, a less 

vigorous process than prescription drugs go through. Again, as is 

my understanding, FDA does not require clinical trials for 90 percent of medical devices that are sold in this country. 

Again, my understanding is this was a process that was supposed to be for minor changes in simple devices. GAO recently reported that it is inappropriately being used for implanted medical 

devices and life saving medical devices. 

The New York Times report has been used for diagnostic tools 

used to diagnose cancer. If the devices are not safe or accurate, 

people die. 

My question is should not the FDA always require clinical trials 

to prove that implanted medical devices are safe and effective and 

should not clinical trials be required to prove diagnostic accuracy 

of devices used to detect cancer and other life threatening diseases? 

510K PROCESS

Dr. SHARFSTEIN. Those are two excellent questions and I think 

the 510K process has obviously been subject to a lot of different reviews and questions. I think it is something that both Dr. Hamburg 

and I are going to want to understand pretty well. 

I know FDA has started the process of making sure the products 

that should go through the pre-market approval process are going 

through it and a whole bunch of products that had been put in the 

510K pile or I should say were sort of grandfathered out are now 

getting pulled back in. 

In terms of what actually should require clinical trials, I think 

that has to be a judgment call based on the particular product. I 

will give you an example. 

If there is a product, even if it is implantable, say there is a very 

clear improvement that you could prove in the lab, in other words, 

internal to the device, that made the device more stable say, and 

you could prove that in a million different ways in the lab, that it 

is clearly more stable and it is all internal to the device, it may be 

a scientific judgment that you do not have to randomize people to 

the old version, which we think is less stable, if you have a ton of 

evidence, and it is evidence. It is just not in people, that it is going 

to be better. 

You would not necessarily need a clinical trial for that. For a 

cancer diagnostic, I think it also might depend. If you have confidence in the approach based on a whole bunch of other science 

that this worked for these other four tumors and you know this is 

the same basic concept, you might want some clinical data but 

whether you would want a clinical trial, I am not sure. 

I think it is not so much the—the law gives FDA considerable 

flexibility. The key is for FDA to be making good scientific decisions. I think one conclusion that I have kind of drawn in my limVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00123 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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ited time at the agency is that a lot of—it is very important for 

FDA to explain its decisions. 

If FDA is going to put a device in the 510K pile because they 

think it is equivalent to a previous device, why, what is the basis 

for that decision. What can FDA do to explain that and then people 

can agree or disagree. 

Ms. DELAURO. Make a judgment. 

Dr. SHARFSTEIN. It is right out there. I think some of the reason 

for the concern over the 510K process may be that FDA is doing 

it wrong or it may be that people do not really understand what 

FDA is doing. 

I think that is an important more general issue for us to tackle. 

This is an area that people feel like to a certain extent is behind 

the curtain, and when making decisions on things like this, FDA 

should be explaining itself. 

Ms. DELAURO. Thank you. That is my last question. We will submit some for the record. I thank you for your time, your patience, 

for your commitment to this effort. 

I will end with where I started. I am very, very much looking forward to working with you and collaborating on an area and an 

agency that I have the utmost regard for and respect, and it has 

a function in our society which I believe is very, very critical to the 

health and safety of the people of this country. 

I want to also say you have a number of your folks with you 

today and I will continue to say to them, many of them have been 

here in the past and have spoken up, but I will ask the same questions of the people who are currently in charge as I asked of the 

people who were previously in charge. 

I am excited, quite frankly, I would be less than honest if I did 

not say, of a new environment, an environment which I think can 

help us to go back to the mission of the agency, which is regulation 

but founded on sound science. 

I look forward to that and am encouraged by our conversation. 

Thanks very, very much. 

Dr. SHARFSTEIN. Thank you. 

Ms. DELAURO. The hearing is adjourned. 


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TUESDAY, JULY 28, 2009. 

PROTECTING THE PUBLIC HEALTH IN A GLOBAL ECONOMY: ENSURING THAT MEAT AND POULTRY IMPORTS 

MEET U.S. STANDARDS 

WITNESSES 

WENONAH HAUTER, FOOD AND WATER WATCH 

LORI WALLACH, PUBLIC CITIZEN 

KEVIN BROSCH, DTB ASSOCIATES, ON BEHALF OF AD HOC COALITION 

FOR SOUND SCIENCE AND TRADE 

Ms. DELAURO. The hearing will come to order. Good morning. 

Thank you all for attending today. The subject of today’s hearing 

is Protecting the Public Health in a Global Economy: Ensuring 

That Meat and Poultry Meet U.S. Standards. 

I particularly want to say a thank you to Kevin Brosch, Lori 

Wallach, and Wenonah Hauter for coming to speak with us today. 

One of our core responsibilities on this committee is to ensure 

that the agencies under our purview safeguard America’s food supply. Not all the dangers that threaten the health and safety of 

American families can be found in airport, border checkpoints, or 

harbor containers. Sometimes they lurk in our fridges and on our 

kitchen tables. And protecting our food supply is not just a crucial 

matter of public health, it is vital to the success of our farmers and 

our ranchers. 

With that in mind, today we will review the process used by the 

USDA, the United States Department of Agriculture, to determine 

equivalency between the food safety systems of different countries. 

Specifically, I have concerns about the granting of equivalency 

for processed poultry from China, processed poultry being the 

chicken that ends up in chicken soup, canned chicken, breaded 

chicken tenders, and a host of other products on the American market. 

To use the exact USDA language, processed foods, which I believe is important to note, are exempt from country of origin labeling, our retail items derived from a commodity that has undergone 

specific processing, such as cooking, curing, smoking, or restructuring, or that have been combined with another food component. 

It is my belief and my concern that this granting of equivalency 

to China was extremely flawed and based on trade promotion rather than public health concerns. 

Decisions about the importation of food products from China or 

anywhere else are a public health issue that cannot and must not 

be entangled in and subordinated to trade discussions. 

In its 2005 audit report on its inspections of several plants in 

China, USDA found disturbing, unsanitary conditions, such as 

grease, blood, fat and foreign particles being observed on product 

contact areas of conveyer belts. Yet despite these findings, USDA 


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found that the food safety system in China was equivalent to ours 

in the United States. And once this equivalency was granted, we 

ceded much of our ability to ensure the safety of these poultry 

products to the country in question, in this case China. 

This experience with Chinese processed poultry raises troubling 

questions about the equivalency process, which I hope this hearing 

explores today. As I see it, there are four main questions which 

this hearing should attempt to address, and which we should take 

as a guideline for equivalency reform in the future. 

First, can we come to a conclusion on whether the declaration of 

Chinese equivalency by the USDA was valid and well-founded according to the standards of equivalency already outlined by the 

agency? 

Second, if not, why not? Is there a way or process we can establish equivalency, using the standards that are currently in place? 

Third, do we know how to correct the problems that arose with 

China’s equivalency based on how we currently determine equivalency with other countries such as Chile, Canada, Australia, to 

name a few? 

And finally, what do we need to change about the equivalency 

process more broadly, independent of the example of Chinese processed poultry here? 

We intend in this hearing to undertake a thorough review of the 

USDA equivalency process. Quite frankly, that may necessitate further hearings, until it can be established that the process used for 

determining equivalency is focused primarily on protecting the public health rather than facilitating global trade, and that it is based 

on sound, scientific assessments, rather than business-minded, 

wishful thinking, or political considerations. We need to tread carefully. 

Particularly given the contaminated food outbreaks we have experienced in our own country of late, the continuing concerns about 

the safety of other products coming out of China, such as toys, and 

the relative lack of transparency in the Chinese safety system, we 

need to make absolutely sure that we do not open the door to potentially unsafe processed meat and poultry imports from China or 

anywhere else around the world. 

We all believe in the value of trade. However, we also believe 

that the health and safety of American families are nonnegotiable. 

It is our charge and that of the USDA to ensure that consumers 

do not have to worry about the safety of processed poultry products 

on the market. And we are here today to ensure that the USDA 

is living up to its most important responsibility and is always putting the public health first, above considerations of global trade. 

To discuss the question today we have three panelists with us. 

We have Kevin Brosch. Kevin Brosch is a cofounder of DTB Associates, LLP, an international policy and agricultural policy consulting firm. Between 1989 and 1999, he served as Deputy Assistant General Counsel for International Trade in USDA’s Office of 

the General Counsel. Mr. Brosch also served as legal adviser to the 

USDA team negotiating the agriculture and sanitary and 

phytosanitary agreements in the WTO Uruguay Round, and he supervised and participated in the negotiation of the agricultural portion of the Northern American Free Trade Agreement. 


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I should also mention that my staff asked a coalition of industry 

groups to send a representative to today’s hearing to discuss their 

views on this matter, and they said that Mr. Brosch’s testimony 

would speak for them. 

Lori Wallach is Director of Public Citizen’s Global Trade Watch 

Division, a Harvard trained lawyer. Wallach has testified before 

more than 20 U.S. Congressional committees on trade and 

globalization matters. She has served as a trade commentator on 

numerous domestic and foreign news outlets. Her most recent book 

is Whose Trade Organization: A Comprehensive Guide to the WTO. 

She has also contributed to numerous anthologies, including the 

International Forum on Globalization’s Alternative to Economic 

Globalization: A Better World is Possible. 

Wenonah Hauter is the Executive Director of Food and Water 

Watch, a nonprofit consumer organization founded in 2005. She 

has worked extensively on energy, food, water, and environmental 

issues at the national, State and local level. From 1997 to 2005, 

she served as Director of Public Citizen’s Energy and Environment 

Program, which focused on water, food, and energy policy. From 

1996 to 1997, she was Environmental Policy Director for Citizen 

Action, where she worked with the organization’s 30 State-based 

groups. 

I want to say thank you all for attending. We look forward to 

your testimony. Before you start your testimony, and I will ask you 

now and also again before you begin, your entire testimony will be 

in the record and we will ask you to summarize and speak between 

5 and 7 minutes. I know the staff will kill me, but it is 5 and 7 

minutes to get out what it is that you want to get out. 

With that, let me yield to my colleague, the ranking member of 

the committee, Mr. Kingston from Georgia. 

Mr. KINGSTON. I thank the chairwoman for yielding, and I thank 

you for holding this hearing today. 

We have a great number of very good, very fruitful hearings in 

this committee and we have a great atmosphere of agreeing to disagree. I would really thank the Chair for having this hearing 

today, because so many in Congress will make a stand but then 

they won’t defend the stand. The Chair has taken a position and, 

by proof of this hearing, is letting it be challenged, and rather than 

hiding in the shelter of the majority, which unfortunately both 

sides are guilty of in the past, I think it is very good to have this 

hearing today. 

I also agree with the Chair that food safety is paramount to 

trade, and I can say that as somebody who voted against GATT, 

somebody who voted against NAFTA, and somebody who voted 

against most favored nation status for China. I think that we have 

to be very careful when we are dealing with trade partners and 

some multi-trade agreements, if not all of them. We have to be very 

cautious. I think safety does have to take precedent over trade. 

Now, I do think there are three points we want to make as we 

start this hearing that are very important. Number one, while we 

do have the industry groups represented, we do not have USDA or 

FSIS here, and I feel that we maybe should consider having further 

hearings in which we get to cross-examine them on equivalency, 

because certainly they would have the opportunity as people who 


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are on the ground to let us find out did you rush this through 

under political pressure or do you really feel that the Chinese-reimported poultry is safe? 

So I do think it is a missed opportunity not having FSIS here, 

but perhaps in a second hearing we can do that. 

The second point I want to make is there is sometimes in Congress, in political bodies, an assumption that if we don’t prevent 

something happening then other groups are going to let it happen. 

And in this case, there is almost a subtle message that we may inadvertently be sending that American industry is more concerned 

about the profit than food safety. And I don’t think that is the signal we want to send. I believe that American corporate citizens are 

good citizens and don’t want to, in fact, poison their own people. 

I will point out, as I have many other times, the U.S. food safety 

success rate. According to the CDC, 76 million food-borne illnesses 

are reported a year. That is a big number: 76 million. 300,000 hospitalizations, 5,000 deaths. 

Now, we who study this know that there are preexisting illnesses 

and immunity problems in terms of some of these deaths. But putting that aside, 5,000 is a very serious number of deaths. 300,000 

hospitalizations. We all take these numbers to heart. 

Taking a step back, though, if you have 300 million Americans, 

which we have more, and we have visitors all the time, and they 

eat three meals a day, which they eat more than that, and they 

have snacks. Multiplying that times 365 days a year, you are looking at 900 million meals, without snacks, eaten by 300 million people. That comes out to 328 billion meals a year. 

Doing the math by that, 76,000 divided by 328 billion, you get 

a food illness rate of .0002 percent, or a success rate of 99.98 percent. 

Now one of the things that our witnesses and I share in common 

is that the FDA doesn’t do a good job, and the USDA doesn’t always do a good job. But if the food safety record is this, according 

to the CDC, then who would we attribute that to? We would attribute it to the private sector and American industry. Then obviously if you are a food processor, you don’t want to put poisoned 

food out on the marketplace, even if you don’t care about people, 

because you don’t want them to get poisoned. You want them to 

come back next week and buy more of your stuff so you can make 

more money. 

But these are important statistics to keep in mind if we feel that 

the FDA and the USDA do not do a good job on food safety because 

you have to come to the conclusion that there is another factor out 

there worrying about food safety, and I would say that it is the private sector. 

The third point I want to make in terms of our trade with China 

is we are picking winners and losers. Case in point, these are some 

goods that we are importing right now from China. 

Seafood medley, and it says, ‘‘For fast, easy, fun seafood dishes.’’ 

Thank you, Mr. Latham. 

Grilled wheat cakes with real octopus. No meal would be complete without this. Imported from China. 

Organic—some kind of beans. 

Mrs. EMERSON. Edamame. 


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Mr. KINGSTON. Edamame. Is that Chinese or is that a Missouri 

word? 

Ms. DELAURO. Soybeans. 

Mr. KINGSTON. Maybe I am more careful here. But organic. Now 

the question would be, we go over what is the definition of organic? 

I am wondering how they earned that organic label? Is there an organic equivalency? I would say there is not. 

Okay, Ms. Emerson, kamame? Noodles. 

Mrs. EMERSON. Those are just noodles. 

Ms. DELAURO. Who does the grocery shopping in your house, 

Jack? 

Mr. KINGSTON. I do it, but I go straight to the poultry. 

Raw and unsalted sunflower seeds. I always think of that as 

being Kansas. 

Shelled edamame. Here it is again. It is very popular somewhere. 

No Thanksgiving dinner would be complete without dried seaweed. 

I am not sure how to pronounce this particular word, but again 

imported from China. 

Now Mrs. Emerson is going to talk about that product. 

Mandarin oranges from China. 

Mrs. EMERSON. They are scary. 

Mr. KINGSTON. This is floating in some sort of syrup, I am not 

sure what. In light syrup. 

Smoked oysters in sunflower oil, salt added. 

Straw mushrooms, whole peeled. 

Bumblebee smoked oysters. 

Stir fry sauce, simply Asian. 

Water chestnuts. And this was just one quick shopping trip. This 

wasn’t let’s go out on a Chinese survey and try to find things. 

These are products right now that we can import from China. 

So my question is: Should we not also be having a ban on these 

things, or are we sure that the FDA does it a little bit differently 

than the USDA, that we do not trust the USDA but we do trust 

the FDA? And I think that if we were going to be maybe philosophically honest here that we should either ban them all or review 

them all or treat them the way that we are treating poultry. I ask 

that question because I think sometimes government can pick winners and losers and inadvertently you can do a disservice to our 

consumers out there, the public that we want to serve. 

I will close with this. We are very interested in this hearing 

today. Again, I thank the Chair for having it. I want to know all 

about it, but keep in mind that my position and others on the committee is not saying let’s import Chinese chicken as much as it is 

let the process work. Apparently the process works for this through 

the FDA. We should let the process work through the USDA. 

Thank you. 

Ms. DELAURO. I thank the gentleman. Let me actually make 

three points. 

One, I would have loved to have had the new Undersecretary 

from the USDA be here today. But in fact there isn’t an Undersecretary yet for the FSIS, Food Safety Inspection Services. So it may 

be we do, as I said at the outset, Congressman Kingston, that we 

may want to do further hearings. 


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I would also like to introduce Dr. Richard Raymond, who is here 

and who is a former FSIS Director, and welcome. I am not sure 

where you enjoy being seated more, where you are now or here, but 

you have always been very up front and candid, and I enjoyed 

working with you, Dr. Raymond. Thank you very much. 

Before we begin testimony, I would like to say what an array of 

products, Jack. But you should know in February of 2009, FDA’s 

import actions with regard to these Chinese products stopped: Frozen pollack, filthy; breaded shrimp, unsafe animal drug; rice stick, 

filthy; dried mandarin peel, maybe from those mandarin oranges, 

filthy; frozen squid tube and tentacles, filthy; breaded shrimp, unsafe animal drug, nitrofuron; soy protein powder; poisonous frozen 

tilapia, unsafe animal drug; frozen frog legs, salmonella. Oyster flavor sauce. Anyway, the list goes on and on and on. And that is February of 2009. 

With that, I am going to ask Mr. Brosch if you will begin the testimony for us today. 

Mr. BROSCH. Thank you, Madam Chairman. I have my full testimony here for the record. 

Ms. DELAURO. Yes. 

Mr. BROSCH. Thank you, and I ask that it be accepted. 

Good morning, Madam Chairwoman and members of the committee. My name is Kevin Brosch. I appear today on behalf of the 

Ad Hoc Coalition for Sound Science and Trade. With me is Mr. Bill 

Roenigk, the Vice President of the National Chicken Council. The 

Coalition appreciates your invitation to present its views. 

The Coalition consists of 39 trade associations and companies engaged in domestic production and international trade related to 

meat and poultry products, including trade with China. Its members are listed in the attachment at the end of my testimony. 

The Coalition urges Congress to reconsider section 723 of H.R. 

2997, the House version of the 2010 agricultural appropriations 

bill. Section 723 would continue to prohibit USDA’s Food Safety 

and Inspection Service from implementing or advancing any regulation regarding potential imports of Chinese poultry products. The 

Coalition has two simple points. 

First, public health and safety are paramount considerations in 

the production, processing, and distribution of the food supply, and 

we need effective FSIS regulation of meat and poultry products to 

ensure public safety and public confidence. 

For companies in the food business, food safety is an everyday 

preoccupation. They have a legal and moral responsibility to place 

a safe, wholesome, properly labeled product on the market. And 

they also live with this simple marketplace imperative: If the public even perceives that a product is unsafe, the public will stop buying it. 

It is not enough that your product is safe, your competitor’s product must be safe, too. USDA has a long successful history of ensuring the safety of imported meat and poultry through a stringent, 

comprehensive process of determining regulatory equivalency and 

approving individual plants. U.S. standards are very high and very 

tough to meet. Many countries have applied to ship poultry to the 

United States over the years, but only five are approved and ship 


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here now. Accordingly, all meat and poultry products, domestic or 

imported, must meet our national standards. 

Second, the United States should apply its food safety requirements to imports in a manner consistent with international trade 

rules, and in particular with our obligations under the WTO agreement on sanitary and phytosanitary measures. The United States 

insists that other countries abide by SPS rules, and we must treat 

our trading partners, including China, as we want them to treat 

us. 

Any WTO member country that applies to ship meat or poultry 

products to the United States can have the safety of those products 

determined on the basis of science and risk assessment. Only 

China has been singled out for different and less favorable treatment. 

China has invoked its right to WTO dispute settlement. It asserts that current U.S. law contravenes WTO obligations to afford 

China Most Favored Nation treatment, and that that law is inconsistent with SPS articles 2 and 5, which require that SPS measures 

be based on sufficient scientific evidence and appropriate risk assessment. 

The Coalition is very concerned by these developments, and apparently we are not alone. Recently, the Obama administration in 

its comments on H.R. 2997 also noted its concerns regarding the 

consistency of section 723 with U.S. International obligations. 

Section 723 sends the message, perhaps unintended, but nonetheless grave, that U.S. food safety regulators cannot be trusted to 

do their job. The confidence of the U.S. consumers and the safety 

of meat and poultry is based, to a significant degree, on their trust 

that FSIS is an effective regulator. Also, most other countries accept our exports based on FSIS certification. What does section 723 

say to our consumers and our trading partners about our food safety system? 

Second, the United States regularly invokes SPS rules to nontariff barriers and to maintain market access for U.S. products. 

U.S. Trade Representative Ron Kirk recently announced the 

Obama administration trade policy emphasizing enforcement, particularly in the SPS and TBT areas. This administration’s policy to 

enforce U.S. trade rights will be severely undermined if the United 

States itself is held to maintain WTO inconsistent policies. 

Third, section 723 is eroding our trade relations with China. Importers applying for permits to enter U.S. poultry products are 

being told that the permit office is closed for the holiday, even 

when there is no holiday. China can use these or other tactics to 

shut U.S. poultry products out of its market when it considers that 

it has been unfairly treated. 

China is a $700 million market that the U.S. poultry industry 

has worked long to develop. It is now at risk. 

I would say in conclusion that this Coalition does not advocate 

any specific result. It advocates for a process that is consistent with 

our WTO obligations. It does not prejudge the outcome of any risk 

assessment that FSIS may conduct with respect to Chinese poultry. 

FSIS may determine that Chinese product meets U.S. standards 

and may be safely imported. Or, FSIS may conclude that that product does not meet our standards and therefore cannot enter the 


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market. The Coalition simply asserts that the process of sciencebased risk assessment, inherent in both our national legislation 

and in international trade law, must be respected and that our interests in a safe and reliable food supply, and fair and predictable 

trade rules and in sound U.S. trade policy are best served by allowing FSIS to proceed in the case of the Chinese application, as it 

does in all other cases. 

Thank you, Madam Chair. 

[The statement of Mr. Brosch follows:] 


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Ms. DELAURO. Thank you very much, Mr. Brosch. 

Ms. Wallach. 

Ms. WALLACH. On behalf of Public Citizen’s 100,000 members, I 

want to thank the chairwoman and the committee for the opportunity to discuss this problem of ensuring that consumer safety is 

protected in the context of America’s increasingly globalized food 

supply. 

Since NAFTA and the WTO, there has been a rapid growth of 

imported food coming into the U.S. Our current trade pact rules 

prioritize the expansion of food trade and literally limit countries’ 

domestic food safety policy space, which gets to the question about 

whether we need to change some of the WTO rules as compared 

to focus on whether or not our current practices, which promote 

safety, comply with the existing rules. 

Finally, the way that some U.S. agencies have applied the trade 

rules; for instance, with USDA and meat and poultry equivalence, 

have resulted in U.S. consumers increasingly being forced to rely 

on foreign governments to regulate the safety of the foods purchased and consumed here. 

Unfortunately, our recent experience, the headlines we all see in 

the news have shown that quite frequently other governments are 

not up to the task. We still have improvements in this country 

after all the infrastructure, experience, and years of fighting for 

food safety. Relying on foreign governments and their food safety 

systems to protect Americans’ health is a recipe for disaster, and 

it must be changed. There is a way to get the benefits of trade and 

still ensure food safety for U.S. consumers. However, under our 

current trade rules, this is difficult. 

I am going to summarize the six points that are in my testimony 

for the record. The first point is the fact of the increasing share of 

Americans’ food coming from or being processed or grown in other 

countries. In the 15 years since the implementation of NAFTA and 

WTO, what was a trickle of imports became a flood. So now, $80 

billion in food are imported into the U.S. Annually. That is over 

double the level when NAFTA and WTO went into effect. 

Number two, this shift has occurred following U.S. entry into 

particular trade agreements that contain trade, investment, and 

deregulatory rules and standardization requirements explicitly designed to increase the volume of food trade. 

So NAFTA in 1993, WTO in 1994, these agreements enforced 

systems of rules. WTO has 17 different agreements. These agreements prioritize expanding volume of ag trade over food safety. I 

am not saying that is a theory, it is explicit in the rules. Number 

one, the WTO tariff rules require that you set your tariffs low 

enough that every country is importing at least 5 percent in each 

tariff line. Even if you are exporting, that is about increasing the 

volume, that is not even about rational efficiency. 

Number two, the agreements contain new foreign investor rules 

that safeguard and in fact incentivize relocating production and 

processing offshore. 

Number three, the rules in these agreements facilitate trade expansion by limiting the kind of import safety terms and inspection 

rates that can be applied on the return. The specific rule is all 

countries shall ensure the conformity of all laws and regulations 


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and administrative procedures, which is to say we are supposed to 

change our domestic laws to meet the trade rules. 

Finally, the trade pacts provide a mechanism for exporting countries to challenge domestic food safety laws in other countries and 

seek their elimination. 

One of the 17 WTO agreements is the agreement on sanitary and 

phytosanitary measures, the so-called SPS agreement, and in the 

name of facilitating trade, that agreement, in sum, does the following 4 things: Number one, it sets a ceiling on food safety standards. 

Countries are to use, number two, international standards whenever possible, and any standard providing a higher level of protection is subject to challenge. There is no floor, it is only a ceiling. 

Number three, it requires that domestic food safety measures be 

constructed in the least trade-restrictive manner, which is to say 

trade comes first, and then you figure out what also works for safety. 

Number four is a requirement that other countries accept imports that meet other country safety standards but not the importing country’s safety standards. Taken in combination, the agreements effectively are deregulatory superstructure, which undermines our strong domestic policies to protect the food safety. 

Now I found the Obama administration comments on the chicken 

measure extremely worrisome because the issue here, as President 

Obama said as a candidate, is how to make sure our trade agreements, as he noted, which might need renegotiating, make sure we 

have product safety, and that as a priority, as compared to criticizing whether a product safety measure meets a trade agreement, 

should be our focus. 

We have to ask how we got these rules. My testimony goes into 

more detail on this, but when NAFTA and WTO were negotiated, 

there were 500 corporate representatives on the official U.S. Trade 

Advisory Committee System. There was not a single consumer, 

public health, or safety organization. So under the theory of he who 

writes the rules rules, we got rules that satisfied the advisers. And, 

in fact, agribusiness firms have been openly interested in trade 

rules that would facilitate the ability to have a global single marketplace with production overseas. 

A recent APHIS report talks about companies such as Perdue, 

Tysons, Smithfield, ConAgra all relocating plants abroad, many in 

order to send products back under U.S. equivalency standards. 

Now these equivalency standards, the basic question that neither 

USDA or any government agency engaged in trade related equivalency has answered, is the fundamental paradox, which is how can 

something that is different be the same? Which is to say we expect 

U.S. consumers expect that the food that comes to their plates, regardless of where it is grown, processed, or comes from is going to 

meet U.S. standards. And if the basic rule of equivalence is that 

you must accept things that do not meet your standards, it begs 

the question of how we can satisfy U.S. consumers because the 

basic rule for trade equivalence is that it is a process where the exporting country gets to show you that their system, which may be 

substantially different, is good enough, meets your goals, even 

though it may be very different, and then you are required to take 


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the food under their system and treat it as if it was under your system. 

Now, different WTO signatory countries have implemented this 

in different ways, some of them with more focus on safety than the 

way USDA has done it in the U.S., and in fact FSIS brags it has 

gone the furthest in trade facilitation equivalence in its own materials. The trade agreements don’t define what equivalence means, 

and therein lies the space for USDA to create a new equivalence 

policy that can increase the public health focus. There is more room 

to put focus on public health. But regardless of what it could mean 

in the U.S., during the Uruguay Round Act implementation the 

U.S. previous standard which required sale of meat in the U.S. 

from foreign countries to be ‘‘equal to’’ all U.S. safety standards 

was switched to ‘‘equivalent to.’’ This change in language from 

‘‘equal to’’ down to ‘‘equivalent to’’ was done in the Meat Act and 

in the Poultry Act. 

As a lawyer I would say it was actually not necessary to make 

that weakening. There was nothing in the WTO agreement that 

would define it downward. However, whether or not it was necessary, that is what was done. 

USDA at different times has stated that they will only accept 

food under the system that meets U.S. standards, and alternatively, in issuing the regulations, have said they can no longer 

require that food meets U.S. Standards. This is something that 

needs to be clarified. All food sold here must meet U.S. standards. 

But instead of FSIS staff going to other countries and explaining 

how to meet U.S. standards so that we can have the benefits of 

trade and food safety, now FSIS staff spend a lot of time discussing 

amongst themselves whether varying technical standards and different foreign regulations are close enough to be able to rely on 

them for U.S. consumers. 

Bottom line is that now the meat industry in foreign nations who 

have different standards certify their own plants where the USDA 

used to certify plants under their own systems, and it comes in. 

This gets to Congressman Kingston’s point about the market incentives, which has repeated violations by foreign plants of U.S. law, 

do not, as it would in the U.S., result in them being shut down so 

that they need to actually follow the rules. 

Instead, it is a two-tier system where the U.S. plants have to 

meet the U.S. law, the foreign plants can meet their own law, and 

they are supposed to compete in the same market. And as consumers, we are supposed to rely on them. That in a way gets to 

the chairwoman’s number three question, which is it is not just the 

practice, it is the policy. The actual USDA equivalence policy needs 

to be reissued. 

Perhaps the bottom line evidence of that is the fact that under 

that policy it would be even vaguely possible to determine equivalence for the Chinese chicken system. Now I am talking about an 

analysis based on science and an inspection of the actual circumstances. So you would hope that there would be rules such 

that, given what we know of the record in China, not just in the 

chicken plants, but systematically of the government covering up 

safety problems, of people not only being fired but being jailed for 

actually reporting safety problems, of absolutely no culture of acVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00162 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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countability in that government for prioritizing safety of their own 

citizens, much less for the export market citizens, the notion that 

that system, given under the current equivalence formula—USDA 

is in the business of approving countries, not plants, not safe meat. 

So the notion that that culture of non-regulation could possibly fit 

under the current policy is evidence that the policy itself needs to 

be changed. That is an equivalence that never should have been 

found. 

And I want to conclude by saying that it is not just China, because we found equivalence with Canada, despite the fact that the 

E. coli standards are fundamentally different, and for 15 years we 

have been fighting about whether they are safe, and it stayed in 

place. 

Public Citizen did a 2002 report listing all of the equivalency 

problems with Chile and other countries that list systematic, clear 

violations, and equivalence has been left in place. 

So we have three key fixes that we recommend. The details are 

in my written testimony. Number one is for USDA to do a new 

rulemaking to create a new equivalence policy and one that 

prioritizes public health. And we recommend that in doing so, 

USDA consider how NHTSA at the Department of Transportation 

did their rules, as it is a very much public safety-oriented priority 

standard. 

Number two, that the operation of equivalence be tightened up 

to those regulations as specific recommendations. For instance, 

what happens with audits, how often, what happens when there is 

a failure that should be shut down and equivalence determinations 

should end at a certain point, have to be redone to keep the countries on their toes to stay with the standard. 

Finally, we need to fix the trade agreement rules that in their 

first instance would even call for the prioritization of trade expansion, volume expansion, over standards. There is a way to have 

both, and I would recommend a review of the Trade Act, H.R. 3012, 

as a system for how to review and renegotiate some of the food 

safety provisions. Those provisions were negotiated amongst farm 

and consumer groups. 

Thank you very much. 

[The statement of Ms. Wallach follows:] 


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Ms. DELAURO. Thank you, Ms. Wallach. 

Ms. Hauter. 

Ms. HAUTER. Chairwoman DeLauro, Ranking Member Kingston, 

and members of the subcommittee, thank you for the opportunity 

to testify today. I think most Americans would be shocked to know 

that every year since 2006 during the annual appropriations process, that Congress debates whether to continue to forbid funds from 

being used to implement the rule allowing China to import poultry 

products into the U.S. Most people would use their common sense 

and determine that it doesn’t make sense to import a risky food 

like poultry from a country with a food safety record like China, 

from a country that is almost 7,000 miles on the other side of the 

world. 

I will note that we agree with Congressman Kingston that we 

should also look at the FDA process and that the same thing is 

true for FDA and all of these other products. We just happen to 

be talking about poultry today. 

It was politics that determined China was eligible to import poultry into the U.S. There was no honest process based on the evaluation of risk. The inadequate process ignored major problems, and 

approval was rushed through. 

Let us review the events that have brought us here today. In November 2005, FSIS published a proposed regulation listing China’s 

eligibility to export processed poultry products. Food and Water 

Watch was among the groups that raised serious concerns during 

the public comment period. We pointed out that the 2004 FSIS 

audit of seven Chinese poultry and slaughter processing plants was 

problematic. The three slaughter plants failed the audit, two of the 

four processing plants failed. And we believe that a sample of only 

four processing plants was insufficient anyway given that the proposed rule indicated that more than 25 processing facilities would 

be eligible for export. 

It is important to note here that in an August 2008 USDA Office 

of the Inspector General audit report, that inspectors from FSIS 

visited China again in 2005 and conducted another audit. The four 

facilities failed. But there was no publicly visible regulatory activity on the proposed rule until April 18th, 2006, when the final rule 

was sent to OMB. Normally I think everybody is aware that a review of this nature takes up to 90 days. Today, 32 countries are 

eligible to export meat products to the U.S., and eight are eligible 

for poultry products. These countries had to go through a very 

lengthy review. And while it was imperfect, it was many, many, 

many times more rigorous in terms of regulatory hurdles than 

what China was required to do. 

So the rule was announced on April 18th. Stunningly, on April 

20th, 2 days after the rule was sent to OMB, the final regulation 

was announced at the White House because Chinese President Hu 

Jintao was visiting then-President Bush. The rule limited exports 

to the U.S. to shelf-ready poultry products. The rule was clear it 

didn’t include birds slaughtered in China, but USDA officials continued to push for equivalency, even in the face of overwhelming 

evidence that China’s poultry slaughter and processing facilities 

are not really equivalent. 


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To its credit, this subcommittee has been responsible for raising 

issues that have led Congress to prohibit expenditures of funds by 

USDA on this rule. Without the committee’s vigilance, Americans 

would now be exposed to dangerous contaminants and bacteria. 

Lurking in the background is a trade issue that seems to be tied 

to the equivalency of status of China for proposed poultry products. 

China refuses to import beef products from the U.S., ostensibly because of concerns about mad cow disease. But really, China is willing to reconsider beef imports if it can export poultry to the U.S. 

In fact, the Chinese press reported just before the April 2006 visit 

by President Hu Jintao that a beef for chicken deal was being negotiated. 

There was an April 12, 2006, article that appeared in China 

Daily entitled, Chinese Poultry to U.S., U.S. Beef to China, that 

strongly suggested that a quid pro quo agreement had in fact been 

struck. 

While USDA officials have stated that no such understanding 

was ever reached, opening up beef trade with China seems to be 

a very high priority for the USDA. Although some of our domestic 

agribusiness trade associations are using their considerable political power to push for a swap, it is the National Cattlemen’s Beef 

Association who has been very vocal in pressing for a removal of 

the ban on the importation of processed poultry products from 

China. They view it as an impediment to the export of U.S. beef 

to China. 

But we should be clear, imported food from China is not safe. 

Their own government officials have admitted that openly. In 

March 2009, when their food safety law was unveiled, officials in 

the Chinese Health Ministry described the food safety situation in 

their country as grim, with high risks and contradictions. 

The new law which took effect on June 1, 2009, is designed to 

address the problems that arose from the intentional contamination of milk, which caused over 300,000 Chinese citizens to be hospitalized with acute kidney disease and 13 infants to die. I think 

everyone is aware, because milk powder is used in various baked 

goods and candies, hundreds of products were impacted. 

Other imported food products from China have been the source 

of recalls, import alerts, and detention. And since January 2009, 

the FDA has stopped 545 shipments of Chinese food items that fall 

under FDA jurisdiction from being imported. Among the reasons 

cited, illegal veterinary drugs, suspected contamination with melamine, unsafe food additives, unsafe color additives, lack of labeling, salmonella contamination, listeria contamination, unsanitary 

packaging conditions, unsafe pesticide residue, poison, unfit for 

food, and failure to register a food process. 

In addition, currently there are 12 FDA import alerts for various 

Chinese foods, and there have been several U.S. recalls of imported 

Chinese food products such as seafood, candy, baked goods, and pet 

food ingredients. 

We should really wait and see how the new food safety law 

works and whether the government of China can enforce it before 

we allow them to export any more food to us. We believe that the 

equivalency approval process for China was deeply flawed, and the 


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process needs to be started anew, and this should include revoking 

the April 2006 rule. 

Our regulatory agencies must maintain the integrity of the food 

safety system, and regulations must be based on science, not politics. Trade should not trump public health. And while China might 

view this as a quid pro quo, the welfare of U.S. consumers should 

not be sacrificed so that we can open up new export markets. 

[The statement of Ms. Hauter follows:] 


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Ms. DELAURO. Thank you very much, and you all very much. 

If I may start, I would like to, Mr. Brosch, ask you a question. 

Mr. BROSCH. Certainly. 

Ms. DELAURO. First of all, I am just reading your testimony and 

you say we are here to advocate that Congress allow the determination whether poultry from China is safe, meets U.S. requirements, to be made in the same way that decision is made for our 

domestic product and for product from every other country, through 

risk assessment, comprehensive science-based approval processes 

that have been established under our laws and regulations. I concur. I agree with you, and I applaud the commentary. 

Further in your testimony you say, Imported food is expected to 

be subject to the same rigorous standards. USDA has a long successful history of ensuring the safety of imported meat and poultry 

through a stringent, comprehensive process by which the Department must determine that an exporting country’s inspection system 

is equivalent to the U.S. system before approving that country for 

exports to the United States. Beyond that, any plant seeking to export meat or poultry to the U.S. after this equivalency determination has been made must demonstrate its compliance with U.S. requirements. This approval process can take many years, and it 

should. It is the way USDA protects the American consumers from 

unsafe products. 

You go on to talk about the approval process, which is rigorous. 

Let me ask this question because there was a declaration by 

USDA of equivalency with China. But this is what was in the inspector’s reports. And while you can’t read anything that is up 

there, but you have at your desk the inspection documents. 

Mr. BROSCH. This document? 

Ms. DELAURO. Yes. It is a summary of the document which I believe is worth reading. This is what the auditor found. This was for 

four processing plants. Keep in mind the notion was that there 

would be between 10 to 25 processing plants in China. So this was 

four processing plants that China selected. They selected the processing plants and, quite frankly, the three slaughtering plants. We 

didn’t go in and randomly select. They selected the plants for us 

to look at. 

Sanitation control. In one establishment during pre-operational 

sanitation, grease, blood, fat. Pieces of dried meat and foreign particles were observed on product contact areas of conveyer belts and 

plastic containers. In one establishment, over product dripping condensation was observed in several areas. 

In two establishments, edible and inedible containers were not 

segregated in the cut-up area. 

In three establishments there was inadequate light at the reinspection stations. 

In one establishment, tables were missing at the inspection station. 

In three establishments, the conveyer belt used for edible product 

transfer had several deep cuts. 

In one establishment, a rusty pipe with flaking paint was observed over the exposed chiller. 

In one establishment, product contact areas were continuously 

wiped off by a dirty cloth that was not cleaned. 


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In one establishment, non-food contact surfaces of processing tables were observed with heavy grease in the raw meat area. 

In two establishments, employees designated the floor duties 

were handling edible product duties. 

Slaughter processing controls. In one establishment, monitoring 

activities were not adequately addressed in the HACCP plan. 

In one establishment, generic E. coli testing on the whole birds 

was not being performed. 

In one establishment, no testing for salmonella species on whole 

birds was performed. 

In two establishments, there was no pre-chill or post-chill operation performed by the establishment employees or inspection service. 

Now, there was, based on this audit, a determination and a declaration of equivalency with U.S. standards. Now if in the United 

States, Georgia, Iowa, an inspector went into the plant, in inspecting U.S. plants, and found—I could repeat them, but I will not— 

if they found all of these circumstances, would they be declared 

safe in the United States? 

Mr. BROSCH. Of course not. They would be delisted. 

Ms. DELAURO. They would be delisted. Okay. 

Now, I am all—this is science, this is science. This is not ad hoc 

legislation. Science. But there was a declaration of equivalency 

based on these findings. Your comment, just to say back to you, in 

the United States they would have been delisted. 

Mr. BROSCH. Yes. 

Ms. DELAURO. Where do we then provide the same standards 

that we ask of U.S. plants, we ask of foreign plants? 

In addition, I might add—I want to talk about—I believe in what 

the U.S. domestic market is doing. And I do have here the U.S. Department of Agriculture, FSIS quarterly enforcement report from 

January 2009 through March 31st, 2009. And it says here on average with regard to compliance rate that it is 98.8 percent. So we 

are dealing with compliance. This is not compliance, nor is it 

equivalency. 

Let me make one more point. The issue is why we have singled 

out. Your point here where you talk about the USDA approval 

process is exceedingly rigorous, and the approval process can take 

many years, and it should. Let us talk about the approval process 

here. Essentially if I take an October 2004 letter from the Chinese 

Government to Dr. Murano, and they were asking for poultry, domestic Chinese poultry to be let into the country, and I believe they 

asked at that time that we bypass any inspection process. Fortunately, that didn’t happen. 

But let’s go from October of 2004 to—we are talking—what did 

you say, Ms. Hauter—June 1 of 2006, and a determination of 

equivalency in that period of time. 

I would like to ask you why China was singled out for preferential treatment versus any other country. What is that, a year, 

6 months, a year, 7 months, in terms of making that determination? 

I have to make one more point to you, that during this period 

of time, and if you go back, this was, I think the rule was—the discussion about it was November 23rd, 2005, November 21st, was it 


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Detroit operation, Newark, Detroit? Newark. I will get the precise 

citation, in Newark Operation Foul Play. This was U.S. Customs 

that stopped a million pounds of poultry products smuggled in from 

China; smuggled in illegally from China. 

At the same time, going back, June 2004, outbreaks of highly 

pathogen avian flu strains of virus found among poultry flocks in 

eight Asians countries, Cambodia, China, Indonesia, Japan, Laos, 

South Korea, Thailand, and Vietnam. 

June 2005, more human and poultry cases of H5N1 influenza are 

coming to light in Southeast Asia. Human illness in Vietnam and 

the second poultry outbreak in China. 

August 10, 2005, Chinese authorities say they have identified the 

virulent disease that appeared in Sichuan Province in late June. 

Sickened a suspected 212 people so far; killed 38. 

Streptococcus suis, a bacteria in pigs. The 16th to 21st of January 2006, European Health and Consumer Protection Commissioner Markos Kyprianou will visit the People’s Republic of China. 

He is interested in avian flu and human influenza. 

I will just say that is the atmosphere in which all of these deliberations are being discussed. How we could have provided equivalency in this period of time, given what USDA auditors talked 

about, the amount of rigorous time involved in being able to declare 

a country equivalent, and the incredible health circumstances at 

that time when we should have cut off negotiations, in my view, 

and said we have to really take years to figure out whether or not 

we will allow chicken to be processed in China or slaughtered in 

China to come back here. 

Mr. Brosch. 

Mr. BROSCH. Thank you, Ms. Chairman. 

I guess first of all I would say with respect to the smuggled poultry, the million tons, our Coalition or any company of course is not 

in favor of anything that would be smuggled or brought in illegally. 

We want things to go through the process. That is what this is all 

about. With respect to that, we are in total agreement with you. 

That was outrageous. What companies were involved with smuggling should have been brought before the law and punished for 

that. So we don’t have anything to say about that certainly. 

With respect to the sheets that you have put out here, I would 

just note that what you see here, I think, you know, you see a lot 

of bad situations, but you also see FSIS doing its job. What you 

have is FSIS out here, and they are observing and reporting all of 

these things. And at the conclusion of the pages, they are saying, 

if approved, this establishment—the equivalency was approved, 

this establishment would be delisted. And they say that on the second page and on the fourth page. 

Now, we have circumstances where we have approved other 

countries or we have approved plants in our own country who get 

delisted, because even though the decision has been made on the 

equivalency of the system, something goes awry and something 

goes wrong. And our people are on the spot, and they take care of 

it. 

For example, the United Kingdom right now has been approved 

but it is currently suspended. And it is suspended because our inVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00198 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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spectors, doing their job, found something wrong, and they took 

care of that. And they now have that suspension. 

We have companies in this country that are suspended. We regularly have companies—and I am sure Dr. Raymond has told you 

about that on many occasions—from other countries where those 

plants are delisted on a regular basis, have to go through some 

process to get back on. 

So these are unacceptable situations—— 

Ms. DELAURO. But you went and—not you, but the agency— 

based on that data—and believe me, this was done in 2006. Our 

ban, the limitation, did not go into effect until 2007. Between 2006 

and 2007, I don’t know of any going back and saying that this has 

been corrected, that has been corrected. And, by the way, China 

never certified any plant during that period of time. 

But this is not someone that you approved based on good data. 

This is someone that you approved on problems. Wasn’t somebody 

who came through the process, you said it was okay, they had a 

problem, and then you addressed that problem. This was from the 

get-go. This was, day one, you knew of all of these difficulties. 

Mr. BROSCH. Yes. Well, obviously, I left the Department of Agriculture in 1999, and I can’t respond for the Department of Agriculture. I think those are questions they are going to have to respond to, your questions. But I can’t answer that question. 

Ms. DELAURO. And allowing a year and 5, 6, 7 months in order 

to do this progress, does that meet the standards that you have 

laid out in your testimony? 

Mr. BROSCH. You know, I would have to know more facts to be 

able to say that. I mean, you have brought a lot of facts out here 

on the table. I haven’t had a chance to discern those, ‘‘Here are the 

responses,’’ I really can’t answer that. 

Ms. DELAURO. And you also—I just want to repeat your answer 

early on—if you found these circumstances in U.S. plants, you 

would delist them. 

Mr. BROSCH. I would think they would be delisted. 

Ms. DELAURO. Okay. Thank you. 

Lori, Ms. Wallach, do you have a comment? Quickly, because I 

am well over and my colleagues are bearing with me. They will 

take me to task later. 

Go ahead. 

Ms. WALLACH. I just wanted to speak to what those inspections 

were about, because prior to the WTO and the change in the law, 

U.S. officials had to go into each plant and inspect and then decide 

that particular plant was equal to U.S. and certify that plant. 

Now, under equivalence, under the existing rules that need to be 

changed of USDA, they do what is called a paper audit, where they 

look at what the system is supposed to be. But then the plant inspections go to whether or not it is actually being enforced or implemented. 

So, particularly when you have a developing country that hasn’t 

the budgetary or infrastructure or culture of enforcement, those inspections, when you see the catastrophe, are not just about whether or not the plant itself is approved, but rather it is the evidence 

of whether what is on paper is what is in reality. 


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So it was an abomination that that equivalence determination 

was issued. And we thank the chairwoman from saving us for that, 

though it is a scary fact that it was necessary to intervene to stop 

it, which, in a way, gets to one of the structural problems that has 

to change, which is: It is not a matter of what would be delisted. 

We don’t get to pick that. We can go in and audit and see repeated 

problems we don’t delist, because our report from 2002 shows repeated problems in Brazil and Chile and other places. But they get 

to pick. 

So it is the actual country, once you certify equivalence, it is the 

country that picks the plants. And so, it is not even that we would 

be looking at them like we used to once they had been picked as 

an okay plant to say they were no longer okay, which makes that 

set of disgusting information even more horrifying. 

Ms. DELAURO. Uh-huh. 

Mr. BROSCH. Just for the record, we don’t import anything from 

Brazil. Brazil is not approved to ship to the United States. 

Ms. WALLACH. That is not true. 

Mr. BROSCH. Not for poultry. 

Ms. WALLACH. For beef. 

Ms. BROSCH. Not for poultry at all. 

Ms. WALLACH. Right, for beef. Our report in 2002 looked at beef 

and poultry in the equivalence system. So let me clarify: Brazil was 

beef. And they had company-paid inspectors year after year, and 

we allowed it. 

Ms. DELAURO. They do beef, they do mutton, and they do pork 

from Brazil, and not poultry. 

Mr. BROSCH. Not poultry. 

Ms. DELAURO. I just want to make one other point. I think it is 

important. These plants were selected by China for us to look at. 

Two of the four processing plants failed. Three out of three of the 

slaughtering plants failed. 

When you deal with equivalency, we don’t get to pick and choose 

what plants. The Chinese Government, the Brazilian Government, 

the Canadian Government, they pick the plants. We, in essence, 

lose our ability—we are supposed to do a yearly audit, assuming 

we do a yearly audit. We go back and we take a look. But we don’t 

certify, we don’t select the plants, we don’t do the inspection of 

those plants. 

Mr. Latham. 

Mr. LATHAM. Are we going in order? 

Ms. DELAURO. I thought you were representing Mr. Kingston. I 

am sorry. I thought that was the case, but it is up to you guys. You 

tell me what you want to do. 

Mr. LATHAM. Okay. Thank you very much, Madam Chairman. 

And welcome, the panel. 

Some of the correspondence that has been shared with me and 

some of the testimony that I have read today, proponents of the 

ban have, in all intents and purposes, accused American farmers 

of putting sales ahead of public concerns, public health concerns. 

And, in your letter, it says here, ‘‘I was disappointed to read that 

the producers of virtually all meat products in our Nation’s grocery 

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ketplace than maintaining the safety of our food and protecting 

public health.’’ 

I am sure we are going to hear today that trade should not 

trump public health. And I will tell you, if you put yourself in the 

shoes of an Iowa farmer, there would be absolutely no disagreement with that, because only one food safety incident can put that 

farmer out of business. 

And I will tell you that statements like that are absolutely offensive and to my constituents are very offensive. The idea, somehow, 

that they would place sales above the public health I think is 

shameful and has no place in this debate at all. Ensuring the safe 

food supply is absolutely critical to the success or failure of all of 

the agricultural economy. And I really ask people to stop painting 

farmers as the bad guys. 

And it seems to me—and if you look at this, when you look at 

different initiatives that are here, whether it be the indirect land 

use, that farmers are, you know, the cause of all environmental 

problems, that there is in this Congress today a real war on agriculture and the family farm operations. And it simply is wrong, 

and it has to stop. And to keep painting them as the bad guys I 

think is, again, very, very offensive, as far as I am concerned. 

I really wonder why, if proponents of the ban feel as strongly as 

they do about China’s food safety, why haven’t they supported a 

ban on all food products coming from China? 

And it is really frustrating today that we don’t have a representative here from USDA. This is what this is all about. We have no 

one here. We have gone through the whole spend bill this year, the 

ag appropriations bill, and not had any oversight into these agencies. I really wonder why they are absent here today. They should 

be here to defend themselves and provide information. And I have 

questioned, you know, whether we are doing any oversight, as far 

as the Department itself is concerned, with the funding that has 

already been put forth this year. 

But I think a lot of us that represent agriculture and represent 

family farmers are extraordinarily frustrated when we hear them 

being blamed for the type of problems that are certainly in the system. 

Ms. Hauter, you indicate in your testimony that the FSIS has a 

fairly extensive evaluation and enforcement system for meat and 

poultry products and that your organization believes that the process provides better safeguards for consumers. 

Why don’t you advocate a similar funding limitation on foods imported under the FDA jurisdiction? 

Ms. HAUTER. Sir, we have supported a ban on all Chinese food 

products coming into the U.S. 

And, just for the record, I would like to say that our organization 

works very closely with family farm organizations. 

Mr. LATHAM. Such as? Who? 

Ms. HAUTER. And I am actually married to a full-time family 

farmer on my family’s farm 40 miles from Washington, D.C. So we 

would never make an attack on family farmers. 

We work with the National Family Farm Coalition and all of its 

affiliates from several States, from the Alabama Contract Poultry 


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Growers Association. I can list—would you like me to list the 

groups? 

Mr. LATHAM. No, no, that is fine. 

How can you, you know, say—and this is horrible, all these findings. And I will note that they are back from 2004, the most recent 

one, 2005. How do we know that things haven’t gotten any better, 

when you have the prohibition from doing inspections? 

Ms. HAUTER. Well, sir, I, the past 2 years, had the opportunity 

to go to China and attend a food safety meeting. In fact, I will be 

going again at the end of September. And it is a trade show that 

is put on by the proponents of food trade. Dr. Raymond was there 

last year and spoke at the conference. 

And I had the opportunity to speak to any number of Chinese 

people about the food safety system, heard about the problems that 

the government is having from the government officials’ own 

mouths, and, in fact, have lots of concerns about a whole range of 

products, especially organics. 

And I think that we need to really look at the equivalency process again, and for all countries, not just China. Because I think 

China is probably the most dramatic example of problems, but I 

know that when we have looked at other countries from Latin 

America, even Australia, there are major problems—Canada. 

Mr. LATHAM. But if you have the funding prohibition in place, 

how are you ever going to know, on a science-based inspection, 

whether or not there are improvements? Again, this is 4- and 5- 

year-old information. I mean, have they done nothing since then? 

We don’t know, because we can’t inspect them. 

Ms. HAUTER. I think that we need to wait and see how many recalls we have on other products and what happens in China with 

food safety issues. I know that we are monitoring the Chinese 

press. 

Mr. LATHAM. How are we going to know that if we don’t have the 

ability, don’t have the funding to be able to inspect it? 

Ms. HAUTER. Because there are many very dramatic food safety 

problems that have occurred in China—— 

Mr. LATHAM. That were at the trade show? 

Ms. HAUTER. Well, not that were just at the trade show. I think 

the melamine—the press. I mean, the melamine crisis was occurring when I was in China last August. The Chinese people that I 

spoke to were actually outraged, and I think that they are very 

concerned about their own food safety issues. And we need to give 

it some time to see if the government can become accountable to 

its own citizens on food safety and a range of other issues. 

So, what is the rush? We have enough poultry products in this 

country. Why would we put our own citizens at risk just so that 

we can import processed chicken from China? I don’t understand 

why that is such an imperative that we would actually risk our 

citizens’ health. 

Mr. LATHAM. Are we out of time? 

Ms. DELAURO. Look, I went over—— 

Mr. LATHAM. I enjoyed yours though. 

Ms. DELAURO. If you have another question, please go ahead. 

Mr. LATHAM. Well, just kind of that point, in your testimony you 

said, ‘‘Some of our domestic agribusiness trade associations seem to 


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think that there is linkage between the status of poultry imports 

and beef exports.’’ Are you questioning whether there is a linkage? 

Ms. HAUTER. No, I believe there is a linkage when you look at 

the evidence. It is a quid pro quo. And I don’t think that that is 

how we should make public policy decisions on the food that our 

citizens eat; that, so that we can export beef to China, that we 

allow imported pork products into the country. 

Mr. LATHAM. Okay. 

Ms. Wallach, in your testimony you talk about NAFTA and the 

WTO for the explosion of U.S. food imports that gives the impression that, you know, U.S. farmers are hurt by it. In fact, U.S. food 

exports have gone from $37 billion in 1991 to $115 billion last year. 

You know, you are saying that they doubled as far as imports. But 

doesn’t that kind of counteract what, you know, you are saying 

about the negative impact of free trade? 

Ms. WALLACH. Sir, the food import growth rate is 128 percent 

since NAFTA and WTO until the last set of data. And the food export rate is 86 percent. So it makes my point that the volume overall has gone up. 

But the reason why the U.S. trade surplus in agriculture has declined—and, in fact, in 2005, the United States was a net food importer for the first time since 1955—relates to the fact that our import growth is expanding much more quickly, almost double, than 

our export growth. 

Mr. LATHAM. And why is that? 

Ms. WALLACH. I would argue that, under the rules of the trade 

agreements, a lot of production, particularly processing—because if 

you look in the processed lines of tariff lines, that is where the biggest increases are—has shifted offshore to take advantage of lower 

wages and lower safety standards. So, with the equivalent measures, the producers don’t have to meet our standards anymore. 

Mr. LATHAM. But artificial trade barriers of products wouldn’t 

have any effect on that? 

Ms. WALLACH. Well, the areas where we are basically still exporting a lot are areas where, theoretically, that would be the case 

still, in grains. But in the processing and the human value added, 

more expensive, additional value added goods is where we are now 

becoming a net importer. Which gets to—if you look at the tariff 

lines, it looks like the agribusiness companies are shipping the 

human cost to cheaper venues. 

On your question of how we could ever find out if things are better in China, I mean, practically, an approach would be—and this 

gets to the problem with the existing equivalency rules at USDA. 

Right now, if there is a problem, the equivalency isn’t listed, and 

you go back and reassess. 

So what I would suggest is that, for instance, the past determination, which seems on all grounds to have been done terribly— 

even if the rules were right, it seems pretty slipshod—to be to lift 

that assessment and to start over, number one, to get the underlying rules correct, so that, for instance, we go back to a system 

where the U.S. inspectors picked the plants. There is nothing in 

the sanitary and phytosanitary agreement that would require us to 

give us that right. That would help, particularly in the culture of 


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a regulatory system like China that has so many problems in its 

own system. So that might be a way to try and make it work. 

But also, you know, other elements of improvement, not the least 

of which would be to make very clear on the record that, to find 

equivalence, you need to find the system really does provide the 

same level of protection in every regard, which is to say some 

places are going to have to clean up their act if they want to be 

able to send food here versus we just let it come in. And then you 

would go through the process, having gotten rid of the old equivalence determination, fixing the system, and then using the new system of determining equivalence to figure out if whether or not, in 

fact, practically, in this day, if things have gotten better. And 

under a proper system, you could find that food can come from 

China in a safe way. 

It is an assessment that you have to do. I am skeptical because, 

with your colleague’s grocery bag of delectables, I actually look at 

the country of origin labeling, and I avoid stuff made in China, 

food, that has any potential contamination, like the Mandarin 

sauce, et cetera. The dried stuff I am less worried about. But it is 

a pretty severe problem. I mean, if we have had staff who read 

Chinese, who read the Chinese press—because it is only when people start to die that you see in the foreign press coverage of the 

food safety problems—but it is endemic. I mean, it is like the jungle. And so if you can read the actual Chinese language press, 

there is coverage of horrible problems that just don’t get bad 

enough to kill people all the time. 

So it needs to be redone. 

Mr. LATHAM. Okay. 

Mr. Brosch, do you have any comments? 

Mr. BROSCH. Well, I guess I would just reiterate what I said earlier, which is that we are not here to advocate for any particular 

result; we are here to advocate for a process. 

And the process that we are here to advocate is the one that we 

have committed to, which is to allow each country to apply and to 

be evaluated on the basis of risk assessment and science. And to 

simply shut out one country seems to me to be inconsistent with 

the application that we have taken. 

And I think that we owe that to all—now, if the decision is 

taken, that they are not sufficiently safe or their product doesn’t 

meet our standards, so be it. But I think it is the process that we 

are here to advocate for. 

Mr. LATHAM. All right. And I appreciate that, that no one is advocating that we need to bring safe products in here. You know, 

when we have funding prohibitions, we will never know. 

Mr. BROSCH. Mr. Latham, in my testimony, my longer testimony, 

I mentioned—I think all of us can remember alar from years ago 

and its effect on the apple market. And I think it is a good example 

of the kinds of situations that our members, the members of our 

coalition, face, which is: The market is sensitive to these kinds of 

issues, so if you have a situation where there is an unsafe product 

on the market, the consumers are not sitting there saying, is that 

an apple from Washington State or is that an apple from France 

or wherever. They are saying they are afraid of apples. 


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So it is in our interest and all off our interests, probably more 

than anyone else’s, not only because we are consumers and our 

children are consumers and our relatives are consumers, but also 

our businesses depend upon the perception of the American public 

that things be safe. 

So we are very much with the chairwoman. We are very much 

with everybody here who has indicated their interest in safety of 

food product. But we think that there is a process that we have put 

into place that is part of our law for everyone else, that is part of 

our international obligations, and that has to be respected. 

Mr. LATHAM. Right. And that is exactly why I find it very offensive when people make statements that the producers put marketplace over safety. Because that is simply—if you want to be out of 

business tomorrow, if you are—and to sell an unsafe product to 

what is probably your own family knowingly, for profit, that charge 

is—I am very frustrated by it and I am very offended by it. And 

I appreciate it. 

Mr. BROSCH. I have the privilege of, besides working for this coalition, of working very regularly for the National Milk Producers 

Federation, and I go to their meetings. I am their outside general 

counsel. And I can tell you, at the meetings I have had in the dairy 

industry, I have heard more discussion among dairy farmers about 

this issue, how they can improve, how they can be more safe, somatic cell count, everything else. Because they are living right 

there, they are living right there in those circumstances. They don’t 

want to live in something that is unsafe. 

So I applaud your statements. I think that is the way farmers 

and food industry people think in this country; it is just not wellknown. And, unfortunately, they get a bad rap. 

Mr. LATHAM. Right. 

Thank you very much. 

Ms. DELAURO. Let me just, before I yield to Mr. Sanford—because my colleague from Iowa is referencing the letter that I wrote 

to the groups who wrote to me. And I would ask him to take a look 

at the letter that they wrote to me and what they stipulate. 

And now, we are not talking about—and, Mr. Latham, you began 

talking about small farmers. Well, as far as I know, Cargill, JBS, 

Monsanto, Tysons, and several others, these are not exactly small 

farmers. 

I have a high regard for small farmers. I spent a lot of time and 

have for almost 15 years on this subcommittee, not as its Chair but 

as a member of this subcommittee, and now as its Chair, providing 

enormous resources in order that small farmers might be successful. 

And I have dairy farmers. And not that long ago at the Greenbacker Farm in Wallingford, Connecticut, and trying to find out 

how it is, because of melamine in China and children dying in 

China, that the Chinese people do not want to drink milk anymore, 

whether it is milk produced in China or milk produced in the 

United States. And our folks are having a very difficult time with 

that because of the drop. 

So this is not about small farmers. This is about large agribusiness and large producers, who have a very big interest, and 

some, quite frankly, who years ago when this first came out—and 


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the National Chicken Council—who said this would be the wrong 

direction to go in. Tunes have changed. 

Mr. Bishop. 

Mr. LATHAM. Would the gentlelady yield just a second? 

But this letter you write, I mean, you are talking—the response 

is to Cattlemen’s Beef Association, Chicken Council, Pork Producers, the Turkey Federation. You are accusing them of putting 

the sales or trade above food safety. Those are all the small farmers in Iowa and throughout—— 

Ms. DELAURO. I am saying that food safety is to be uppermost. 

It is good to think about trade. There are ways in which we are 

going to be able to deal with this. 

And I would like to ask Mr. Brosch, if I can: Ms. Wallach and 

Ms. Hauter, both talked about a way to start over, to revoke the 

current rule, start again, so that we have an inspection process and 

can move forward to see—in fact, I think it is clear, based on evidence. I am not a scientist. I take advantage of the science that the 

agency has in place. 

Should we start this over again? 

Mr. BROSCH. Are you talking about the USDA rule? 

Ms. DELAURO. I am talking—yes. 

Mr. BROSCH. Well, I think that is a question—the USDA and you 

can have that discussion. I don’t—— 

Ms. DELAURO. You don’t have an opinion on whether we should 

do that. Do you have an opinion on whether we should start over? 

You represent all of these groups. What—— 

Mr. BROSCH. Well, obviously, we are going to have to start over 

or start at some point, because the current legislation has blocked 

any movement on a rule for a number of years now. So I don’t 

know where we are at here, given that situation. So I think that 

discussion would have to have USDA in the room. 

Ms. DELAURO. Fine. 

Mr. KINGSTON. If the gentleman would yield, basically you would 

have to start all over. Because if you jump in halfway, you have 

to make sure it is from A to Z safe. And so you sort of have to start 

all over, by definition. 

Mr. BROSCH. Well, it looks to me like—the data, for example, 

that has been presented here today is from 2004. That seems to be 

a bit dated. I would think—— 

Ms. DELAURO. That is the date, that is the time period on which 

equivalency was determined on that data. Between 2006 and 2007, 

there wasn’t any visits or re-audits or anything of the current state 

of affairs, in terms of correcting deficiency. 

Mr. BROSCH. I am not offering any criticism, Madam Chairman. 

I am just saying, in response to your question whether you would 

have to start all over, since this process has been essentially 

blocked by legislation for several years—and this data goes back to 

2004. I don’t know what the newest data is, but of course you want 

to make your decisions on current data. So USDA would have to 

do something of that sort. And, again, we don’t have USDA in the 

room, so I would think—— 

Ms. DELAURO. I want to address that again. I want to address 

that again. There is no individual at USDA who was head of FSIS. 


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That is not your problem. It is a problem for us, because we can’t 

get the appropriate person up here to be able to ask questions. 

Clearly, as well, this was not the USDA that made this determination. It was a prior USDA. So we are waiting very patiently 

for the new head of FSIS, and then, boy, do I have a series of questions for that new Secretary. 

Mr. BROSCH. Again, Madam Chairman, I wasn’t offering any criticism of your comments. I was simply saying that, in order to answer this properly, somebody from USDA would have to be in the 

room. 

Ms. DELAURO. Sure. Okay. 

Mr. Bishop. 

Mr. BISHOP. Thank you very much. 

Let me join Mr. Latham and Mr. Kingston, Mr. Brosch, in suggesting that I think it is obvious that safety has to be first and 

foremost for our producers, for our farmers, for our processors, for 

our wholesalers, and for our retailers. Because, obviously, if the 

consumer feels that the food is not safe, they are not going to buy 

it. And if it is not bought, it means that all of you, everybody in 

that process, is going to suffer. And, Mr. Brosch, I was happy to 

hear you suggest that, perhaps, as Mr. Kingston suggested, we do 

have to start over with USDA to make sure that our food is safe. 

But I want to just ask this question to all of the panel members. 

Getting back to Chinese chicken, according to the Chinese Government, their poultry industry complies with the international standards and practices with respect to their inspection of meat and 

poultry and that it currently exports poultry to other developed 

markets, including Japan, the European Union, and Switzerland. 

I want to ask the panel members, all of you, if you will, to your 

knowledge, is there any evidence that those other developed nations who currently import Chinese meat and poultry products 

have encountered or experienced any significant issues or problems 

with those products that they have imported from China? 

Mr. BROSCH. Well, Mr. Bishop, I asked that question just the 

other day in preparation for this. My understanding is that the current volume of poultry shipped from China to Japan is about 

10,000 tons a month, which is a fairly significant volume. And, for 

the European Union, which I believe approved shipments from 

plants about a year and a half ago, my understanding is, for the 

first half of this year, there is something on the order of 1,500 tons 

total to Europe, which is not as big a number. 

I asked about the question of food safety problems. I am unaware 

of any. I mean, I don’t have comprehensive knowledge, but I am 

not aware of any, at this point, in those markets. But that is all 

I know at this point. 

Mr. BISHOP. Ms. Wallach. 

Ms. WALLACH. I tried to figure out the same question. I found 

two things, although I am still snooping around. 

One thing is that, for Japan and Europe, which is the information I could find—I couldn’t find out Switzerland—the countries 

have inspectors from their own food safety systems in the plants 

so that—— 

Mr. BISHOP. In China. 


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Ms. WALLACH. In China. And so they won’t rely on the Chinese 

system, and they run a separate line—there is a day when the guy 

from Japan is in a particular plant, and that is the day that they 

can actually run the line—— 

Mr. BISHOP. Are they signatories to the same agreement that we 

are? 

Ms. WALLACH. Yes. That is how they have interpreted it. That 

was my reference to the notion that there are different ways to interpret how you can do it. So that is number one. That is how they 

have interpreted making sure it is safe; they put their own people 

there. 

And so then they have to live up to the actual standard, and they 

are applying their standard. So it is, like, a different day. And, apparently, the way they staff it is they have the inspector moving 

around. There is a particular day or 2 days that it is running the 

Japan line, and then it goes back to what we would otherwise have 

to accept. 

The second thing is that they have a much higher rate of reinspection at the border, which is the second thing I found out. Japan 

and Europe, with respect to high-risk foods, which they characterize a lot of meat and poultry products from China, inspect between 50 and 70 percent. That is, you know, numerous times over 

what we do, which is, what, around 11 percent now. 

So those are the two things I could figure out of how they are 

dealing with the problem. 

Mr. BISHOP. So you would then suggest, I would imagine, that 

we look at the approach that they take to try to make sure that 

ours is safe. 

Ms. HAUTER. Yes, the EU has restricted poultry imports from 

one region of China that doesn’t have avian flu. And China has a 

very decentralized way of addressing inspection issues. It is not 

centralized in the same fashion as ours. There is a lot of discretion 

at the regional level. 

Mr. BISHOP. Through your research, have you determined also 

that they have the people on site? 

Ms. HAUTER. Yes. And they do microbiological testing, as well. 

Mr. BISHOP. On site? 

Ms. HAUTER. Yes. 

Mr. BISHOP. And we do not? 

Ms. HAUTER. No. I mean, one of the things that we would like 

to see is, rather than our current recall system, that we actually 

do testing on site and we get the results immediately, so that we 

don’t need to have recalls. 

Mr. BISHOP. So you are suggesting a more proactive approach? 

Ms. HAUTER. Yes. 

Ms. WALLACH. When I was discussing generally revisiting our 

rule for finding equivalence and I had mentioned that other countries, under the same exact international trade rules, have done 

different things, some of the best practices have been things like 

a more prophylactic ‘‘let’s avoid the stuff coming in’’ versus ‘‘we 

pick up what is left later,’’ but also only this notion of actually not 

only picking the plants but having your people there and having 

your standards being applied by your people. 

Mr. BISHOP. How do you feel about that, Mr. Brosch? 


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Mr. BROSCH. Well, I think USDA would have to respond to that 

better than I, because that is a question of resources. I mean, that 

may be a question of resources in terms of being able to put—— 

Mr. BISHOP. Well, we are responsible for the resources. 

Mr. BROSCH. Yes, sir. 

Mr. BISHOP. But we could, with resources and with direction, 

force them to do it. But I want to know how you feel about whether 

or not that is something that we ought to do. 

Mr. BROSCH. You know, that really—— 

Mr. BISHOP. How you think that the processors in our country 

would feel about making sure that they had on-site inspection—— 

Mr. BROSCH. I will be honest with you, Mr. Bishop. I don’t know. 

I really don’t know. 

Ms. DELAURO. Could you yield for a second, Mr. Bishop? 

Mr. BISHOP. Yes, ma’am. 

Ms. DELAURO. I just wanted to ask another question. 

In our process before, because earlier in your testimony or in 

commentary, that when we were equal to, did we have on-site inspections? What did we have in the past, before the rules changed, 

in terms of some of the facilities? What kinds of inspection regimen 

did we have, in terms of determining equivalency and those kinds 

of things? 

Ms. WALLACH. Even then, we didn’t have people in all the time 

doing continuous on the line that was the U.S. line. 

Ms. DELAURO. Right. But what we do have—— 

Ms. WALLACH. We had USDA inspectors go first pick the plant, 

decide if they met our standards. And then they did audits. There 

were complications. I am not saying that was a blessed system, but 

that sure as heck was better than the current system. 

Now, China and Europe have gone one better, and they have actually figured out ways—and, by the way, this is also—I am sorry, 

Japan and Europe have gone one better. And this is not only in 

China, which is how I threw China in the wrong part of the sentence, they do that also in Latin America. So if you basically want 

to send food there, they make sure that it is going to be safe. 

And, as I understand it, but this—I couldn’t get to the bottom of 

it, contradictory information—they actually have user fees as part 

of how they—because why should—if the company on site should 

have some contribution to how—and it is a sum fee, the way some 

of the new food safety bills have been, where you are not paying 

for a service which you could capture but rather register, you pay 

a fee, and then that is part of getting the inspection. 

Mr. BISHOP. Mr. Brosch, do you have some further information? 

Mr. BROSCH. Mr. Bishop, I wanted to consult with Mr. Ronick 

from the National Chicken Council because I felt bad about not responding to your question, and I wanted to get a little bit more information so that I could. 

In response to the question about how I would feel about having 

U.S. inspectors in plants overseas, the reason I think it is a complicated question is because we ship poultry—we, the United 

States—ship poultry to about 60-some countries. So we are talking 

about not just China, we are talking about Russia and the Ukraine 

and substantial numbers of countries and a substantial resource 


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issue that you would have to address. But, certainly, we are cognizant that it would be an issue. 

But the second is, we do import meat and poultry from a number 

of countries now. I have the list here. I think it is about, oh, maybe 

20 or 30 countries, something like that. And then we have this 

question about whether or not we are going to have 20 or 30 different inspectors from 20 or 30 countries in our plants, as well. Because they may say, ‘‘Well, you know, you send inspectors over, we 

will send inspectors.’’ And maybe that—— 

Ms. DELAURO. 98 percent compliance. 

Mr. BROSCH. Well, I know, Madam Chairman, but that is something we would have to consider, that is something we would have 

to think about and how that would work itself out. But, you know, 

we are talking about a very complicated problem. 

Mr. BISHOP. Yeah, it is a very complicated problem, but, at the 

same time, it is one that would be in the best interest—in order 

to lift the prohibition, it would be in the best interest of American 

consumers. It seems to me it would be in the best interests of our 

American processors if we had a level playing field across the 

globe. 

Mr. BROSCH. It may be. I am just trying to give you the best information I know at the current time. And that may be a discussion that has to be—— 

Mr. BISHOP. And I want to be very helpful, because, you know, 

I have processors that you represent in my district. And I want to 

make sure that they are able to export, that we don’t have this 

quid pro quo thing and the leveraging that apparently is happening. We want to level the playing field because we believe that 

you have the best products and that we have the safest, the highest 

quality, most economical anywhere. But let’s demonstrate a level 

playing field. 

Mr. BROSCH. Well, we appreciate your support, Congressman. We 

do. 

Ms. DELAURO. Mr. Kingston. 

Mr. KINGSTON. Thank you, Rosa. Ms. Wallach, you had testified that we have $80 billion in food goods that are imported to the United States annually. Of the $80 

billion, which ones do you feel safe with and which ones are you 

more uncomfortable with? 

Ms. WALLACH. I, actually, on that question, being more of a trade 

person than a food safety person, though I am in the nexus, would 

defer to my friends at Food & Water Watch. 

Mr. KINGSTON. Okay. Well, it came out of your testimony, the 

statistic. 

Ms. WALLACH. Well, I can give you the general answer to that, 

which is the answer that is common sense, and that is from countries in Europe, from the European Union member countries, from 

Japan, the countries that have advanced food safety systems that 

have been invested in a lot, we are less concerned. Those might literally honestly be equivalent in certain respects to what we are 

trying to do, number one. 

Number two, things that aren’t subject to spoilage through long 

transportation, things that aren’t temperature-sensitive. So, for instance, with chicken and the idea of what temperature you have to 


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keep to keep E. coli from growing, et cetera. Processed foods have 

more of a risk than those that are not processed, except for potential chemical contamination of pesticides, et cetera. 

I mean, what I am saying—I am familiar with all of that. I am 

not familiar with the last data set. I haven’t done a study looking 

at the last set of recalls except for China, which is a lot of the FDA 

recalls are China. 

Mr. KINGSTON. Okay. Then let me ask the question maybe for 

both of you. Do you feel that there were politics involved in the approval of the USDA rule in 2006? 

Ms. WALLACH. Yes. 

Mr. KINGSTON. And that was Ms. Hauter’s statement also. I had 

wondered, since Dr. Raymond is here, to put him on the spot and 

the whole committee—I feel like Perry Mason. Why don’t we pull 

him up here? And could we swear him in and ask him? You know, 

he is a freelance guy now. Could we ask him if he felt pressured? 

He might choose this moment to run, go outside, and make a phone 

call. Is that—can’t do that? 

But I think it is important that we have—yeah, I think we 

should have him come back. Because I am not sure that that is an 

accurate statement. I am not sure that it is inaccurate. I will say 

that trade agreements do tend to have politics involved in them. 

However, I wouldn’t think the USDA would put food safety secondary to trade for the myriad of reasons we have already discussed. 

But what I am also concerned with, Ms. Wallach, is, again, having voted against GATT, WTO, NAFTA, most favored nation status, you know, you now have cream in the coffee, and you can’t separate it. 

And we are at $80 billion in imported food. Are we not looking 

backwards, are we not sticking our head in the sand by saying, 

let’s put this band in place without letting the science rule the day 

and without letting the process move forward? 

And the reason why I say that is, if you look at CAFTA, which 

I think your groups were against—you have been critical of 

CAFTA, which is fine—but it has been in effect for 5 years, and 

not one of those countries has been approved to import food to the 

United States. Chile is still, I think, even though finally we had a 

trade agreement with them, only 2 years ago have they been approved for meat. And, so, you know, that is the process at work. 

Rosa had listed off a myriad of products which the FDA pulled 

off the shelf in February of 2009. Is that not the system at work? 

Is that not the healthy thing? Do you want to—well, I don’t know 

if you want to talk or not. You are welcome to. We are family here. 

Ms. HAUTER. Okay, I will go. 

It is what basically is being caught. And a lot of the contaminants that are being caught may be things that make people sick 

today. But there are other contaminants that, on a long-term basis, 

could be very detrimental to people’s health. 

And I think we need to look at our globalized food system generally and what it means. And it is a larger issue than just food 

coming into the country and safety issues. I mean, we were talking 

about small farmers earlier today and the impact of global food 

trade on small farmers, so that they are not able, basically, to comVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00211 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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pete or to get their product on the market. So we have most garlic, 

for instance, being produced in China. 

I mean, I think that there are a lot of reasons that we need to 

look at this system and that one of the reasons is food safety. 

Mr. KINGSTON. Reclaiming my time, that is not really what the 

issue is here. I mean, what you are talking about is their inability 

to compete. That is a trade issue; that is not a food safety issue. 

And, really, what I am trying to say is you and I lost on NAFTA 

and WTO, and we can’t go back. Now, going forward, shouldn’t we 

lift the ban? And, if there is a problem with USDA and politics, 

was that not settled in November of 2008? 

Ms. HAUTER. Well, it is never too late to have the food safety regulations that we need and to look at a process that has been flawed 

from the beginning. And the equivalency process and the problems 

are a lot bigger than with China. And so, I don’t think it is too late. 

And I do just want to say that I spoke with Dr. Raymond at that 

food safety meeting in China that I mentioned. He gave a speech, 

and he was rushing out of the room. And I said, ‘‘Do you support 

Chinese chicken coming into the U.S.? Are we going to have Chinese processed chicken?’’ And he was on his way to a poultry conference in Beijing, and he said, ‘‘If I have anything to do with it.’’ 

And so, you know, I think there were politics, and I don’t think 

that they were secret. 

Ms. WALLACH. What we are talking about is going forward based 

on the current reality. And so, the reality is these trade agreements passed. We now have a much more globally integrated food 

sourcing system. But we don’t have food safety systems and rules 

that actually are up to that reality. 

Mr. KINGSTON. Well, we actually do for FDA, I think you would 

agree. Or maybe you would say FDA is totally flawed and we 

shouldn’t be importing. I mean, do you—— 

Ms. WALLACH. There have been some improvements made with 

the bill last year, but, no, they are not actually in a situation where 

one should feel particularly safe about their import safety. I mean, 

you either—— 

Mr. KINGSTON. Well, let me ask you, on a scale of one to 10, 10 

being safe, where are the FDA products, in your estimation? 

Ms. WALLACH. Before I do the math on that, because it depends 

on the product—for instance, some of the seafood I would say is 

like a one—what is the bottom? One? Zero? I mean, some of the 

seafood is horrifyingly not safe. 

And some of the other products, such as fruits and vegetables, 

I am less worried about. 

Mr. KINGSTON. So you would support a similar ban on the FDA 

products? 

Ms. WALLACH. Until we come up with a system to ensure they 

are safe? Yes, of course. 

Mr. KINGSTON. So you feel like the USDA and FDA systems are 

so—— 

Ms. WALLACH. Dropping the ball. 

Mr. KINGSTON [continuing]. That lifting this ban—is that a delay 

tactic, or is that a, ‘‘Hey, can we retool this?’’ 

Ms. WALLACH. Well, you were out of the room, I think, when I 

proposed that what we need to do is basically revoke the current 


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rule, get the actually USDA equivalence determination policy 

right—— 

Mr. KINGSTON. Okay, let me ask you this—— 

Ms. WALLACH [continuing]. And then redo it to figure out. 

Mr. KINGSTON. But, now, you are a lawyer. Isn’t that against 

GATT? I mean, wouldn’t that open up an entire can of worms, in 

terms of trade agreements, if we said, ‘‘Okay, we are going to 

change it’’? I don’t know. 

Ms. WALLACH. What the WTO requires is that when a country 

petitions us, we go through a process to determine whether or not 

their system is equivalent, not defined, to our system. And then if 

we deny it without a basis, they can challenge that. 

But if we go through a new process now and we have a basis, 

we determine through the legitimate process this is not up to snuff, 

or if you want to do it, here is what you want to do. That process— 

and, again, the determination based on the criteria we set—is what 

our obligation is. So if we started over, that is not a trade violation. 

We basically have the obligation—— 

Mr. KINGSTON. But we can’t start all over with this ban in place. 

Ms. WALLACH. Well, we have to get rid of the current equivalence 

determination. I mean, it was an abomination that it was made 

that way. And we need to start over and figure out if we can do 

one that is actually kosher, so to speak. 

Mr. KINGSTON. To mix meat terms. 

Ms. HAUTER. Could I add one thing? China never actually certified any plants under the April 2006 rule. And they could have 

because the ban wasn’t in effect until December of 2007. 

Ms. WALLACH. One other thing on the looking forward versus—— 

Mr. KINGSTON. Mr. Brosch? He has, kind of, been champing at 

the bit. 

Mr. BROSCH. No, no, that is all right. I was just going to say, I 

am not sure that that point supports the idea of banning. I mean, 

what that basically says is that China didn’t feel that it could certify any plants. And that seems to be part of the process—— 

Mr. KINGSTON. That would be like the CAFTA countries. 

Mr. BROSCH. Yeah. In fact, we have that situation—— 

Ms. DELAURO. Why? Why couldn’t they certify? 

Mr. BROSCH. Well, they took a look at what they had, and they 

decided they wouldn’t meet our standards, and they didn’t certify 

them. If we have a plant—— 

Ms. DELAURO. They thought they couldn’t, but we thought they 

could. Is that right? 

Mr. BROSCH. I don’t think that had any—the question was 

whether they had a system in place which seemed to be equivalent. 

And the question is, that doesn’t presuppose that you can certify 

a specific plant under that. You may look at the plant and say it 

is not up to snuff, we can’t do that. And we have had lots of situations like that. There are two steps to this. 

Ms. DELAURO. So, because of that, I mean—excuse me, Jack—we 

should then allow this to go—because they didn’t feel that they 

were up to snuff or they didn’t have a system in place to deal with 

this, then we should allow it to happen. We should allow it to happen. I mean, that is a little bizarre here. 

Mr. BROSCH. Could I make one statement? 


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Ms. DELAURO. Could I just make one statement? I don’t understand, as well as that, this was a prelude. I mean, ultimately, as 

in my understanding—and I have a concern about this with regard 

to our domestic industry, and that is that China’s ultimate goal is, 

really, they want to get a domestic Chinese poultry, the ability to 

export that into the United States. 

And, in fact, there was an equivalency determination based on 

slaughter, but they had to backtrack on that given the unbelievable 

conditions. But all of the press commentary at the time was that 

we were on our way to looking at—the process piece was a prelude 

to the domestic Chinese poultry coming into the United States, 

which would, in fact, mightily compete with our small producers, 

the way it has with our seafood industry. 

Mr. KINGSTON. Well, but that gets back to trade and deviates 

from safety. I mean, if they can compete against this garlic thing, 

it is not a safety question; that is a trade issue. 

But Ms. Wallach is now champing at the bit. 

Ms. WALLACH. Just factually, both Honduras and Nicaragua are 

determined equivalent, I believe, for meat, not for poultry. But they 

are both on the list. So those are your CAFTA countries. They are 

actually determined equivalent. 

Mr. KINGSTON. Then why aren’t they importing? 

Ms. WALLACH. That would be a Tony question, about what in 

particular. He is a meat man. 

But on the question going forward versus looking back, I mean, 

we have a system of rules; that is the WTO’s non-tariff barrier 

rules. We have now had 15 years to see how they work. And even 

when this was negotiated, I don’t think anyone contemplated we 

would be as integrated as we are now. 

So taking the incoming data of how it is working, different countries have done different things to make it so that they can have 

the benefits of trade and still have safety. So you have, for instance, the European Union and Japan doing their in-site inspection thing. You have different countries that have just said, ‘‘We 

can’t afford it; we are not going to certify as equivalent.’’ There are 

a lot of countries that have denied equivalence determinations. 

We need to keep up with the times. 

Mr. KINGSTON. So if we had, say, an amendment in committee 

that said we would have a system similar to Japan, you would be 

comfortable with it? 

Ms. WALLACH. I would like to look at specifically what you had 

in mind with the details, but I would suspect we would be a lot 

more happy than that than our somewhat what appears to be a 

blinded dartboard approach. 

Mr. KINGSTON. I know I am way over. 

Ms. DELAURO. No, we all are. 

Mr. Hinchey. And then Mrs. Emerson. 

Mr. HINCHEY. Rosa, thank you very much for—this has been a 

fascinating experience. And it is fascinating primarily because it is 

so important. I mean, it is something that is terribly significant, 

and important and significant to all the people of our country and 

a lot of other people around the world. So it is important for us to 

try to understand this better and to do whatever we can to make 

it more effective. 


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We are importing and exporting food materials. Is there any 

clear understanding of the rationale between exports and imports 

of specific elements of the food? In other words, we are importing 

poultry, but we are exporting poultry. Are we exporting more than 

we are importing, or is it the other way around? 

Mr. BROSCH. Well, I can answer that. We are the largest exporter 

of poultry in the world. We export about 3.3 million tons a year. 

Mr. HINCHEY. Yes, that is what I thought. So the fact of the matter is that we don’t really have an internal need to export poultry. 

We produce all the poultry we need. 

Ms. WALLACH. To import it. 

Mr. HINCHEY. And more, actually. We are exporting a lot of it. 

So much of these trade relationships that we have and these socalled free trade agreements that have been put into play over the 

course of years, particularly the most recent, fairly recent ones, 

over the last couple of decades, say, for example, are a little longer 

even, are focused on the level of profits that can be made by the 

people who are engaged in these trade operations. 

So the trade agreements that we have are not really trade agreements any longer, even if they ever were. They are really investment agreements now. They are so-called trade agreements which 

encouraged the investment of finances out of the United States in 

order to maximize the profits that can be made by the importation—manufacture or creation, in some way, and then importation 

of those materials from those other countries here into the United 

States. 

So, apparently, based upon this conversation here and your brilliant answers to these questions and intriguing answers to these 

questions, it is pretty obvious that that is the same kind of thing 

that is happening here. 

Who are the major corporations that are importing food from 

other countries, particularly now, say, China? What are the names 

of the major corporations that are involved in the importation of 

food, poultry and other food, from China to the United States? 

Ms. WALLACH. Well, right now, no poultry is being imported from 

China. 

Mr. HINCHEY. Pardon me? 

Ms. WALLACH. Right now, no poultry is being imported from 

China, thanks to the intervention of the committee. 

Mr. HINCHEY. Okay. Who was doing it before it was excluded? 

Ms. WALLACH. The firms that I understand were interested in 

having this capacity and were looking towards China included 

Perdue and Tysons. Those were the two U.S. companies who were 

seeking this equivalence determination for this particular commodity in that particular country. 

If you look more broadly, you will see that Cargill, Archer Daniels Midland, and a couple of other of the major processors have 

used the trade agreements to relocate processing offshore to lower 

environmental health, OSHA-type standards and lower wages and 

have set up in a variety of other countries—— 

Mr. HINCHEY. Yes. 

Ms. WALLACH [continuing]. To send back to the U.S. market. 

Mr. HINCHEY. Yeah. Well, that is exactly the point that I am 

making. We are dealing with a situation here that is not in the 


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best interests of the people of the United States or people of other 

countries, as well. It is in the best interest of corporate profits for 

people who are in the process of manipulating these trade agreements for their own benefits. That is basically what we are dealing 

with here. 

What are the food imports that are coming in from China right 

now? Any? 

Ms. HAUTER. There is a wide range, a long list—— 

Mr. HINCHEY. Long list. Okay, who are the corporations that are 

involved in that importation of those long list of foods from China? 

Do you know offhand? 

Ms. HAUTER. Not offhand. Major seafood—we can get that list to 

you. 

Mr. HINCHEY. Okay. Okay. I would like to see it, because that 

seems to me what is really happening here. And it is intriguing 

why our country is allowing or even encouraging these kinds of 

things to take place. 

Ms. WALLACH. I think when you look at the trade agreements, 

there are different sets of rules to consider. The investment rules 

have to do with those investment and competition questions and 

offshoring. But then, in addition, the sanitary and phytosanitary 

rules have to do with the food safety issue. So, even as Mr. Kingston described, you separate out what is the trade issue, you also 

have these food safety rules in the trade agreements that limit 

your domestic food safety enforcement capacity and standards. 

So not only do you have the investment rules taking away a lot 

of the risks and costs that used to be associated with relocating to 

a poor country, but then you reduce the import safety you can 

apply, so that even if you weren’t looking at the economic issue, 

you now have also the penalty on the safety side, which, from a 

U.S. producer perspective, is pretty catastrophic. 

Because if you are the actual grower, the farmer, the rancher, as 

compared to the agribusiness company who is the processor, and 

you actually are going to produce, you know, for instance, the milk, 

when there is a crisis someplace internationally, it is the desire 

and the demand for the actual commodity that crashes. 

And so it is the actual producer that gets clobbered by what is 

sometimes a greedy investment decision by the processing firm 

that then exploits the holes in the rules that they helped write in 

the trade agreement that limit the ability to implement the same 

domestic standards on imports. 

Mr. HINCHEY. Yes. Exactly. Right. 

Ms. HAUTER. From USDA’s own reports on value of U.S. food imports from China by category, juices and products of fruits and 

vegetables are 24 percent. In fact, most apple juice is now produced 

in China, not in the United States. 

Food ingredients and preparations, 8 percent; fruits, vegetables, 

and nuts, 10 percent; and fish and shellfish imports account for 41 

percent of value of food imported from China. 

And Food & Water Watch did a report on food safety violations 

of fish, where we found that only 1.3 percent of fish coming from 

China, which is about 32 percent of the fish that we get into this 

country, actually was inspected. 


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Mr. HINCHEY. Well, again, very interesting. And this is something, obviously, that we have to deal with, both from the perspective of the agricultural operation here and the way in which it 

interacts and interrelates and imports from other countries and the 

Food and Drug Administration and other aspects of the responsibilities of the Federal Government overseeing these kinds of operations and activities, which are not being handled effectively. They 

are being handled very poorly. 

I mean, one of the things that you said in response to a question 

was that a lot of other countries take much better care and caution 

in inspecting the quality of food that is imported into their countries, whereas the importers here of food into our country are not 

engaging in that effectively. They don’t seem to be too concerned 

about it. Their major concern is what is the maximization of the 

profits and not the maximization of the quality of the materials 

that are being imported. 

Go ahead. 

Ms. HAUTER. Sir, I wanted to add one other point from another 

USDA report on foreign agriculture service, and they are talking 

about the status of importing poultry. And they say that the regulatory agency in China states that it is not economical to do this. 

‘‘Rising international broiler prices and international transportation costs, combined with the unfavorable exchange rate, make 

re-exports uncompetitive. The issue of cooked poultry exports to the 

U.S. remain’s China’s top market access priority for agriculture.’’ 

Mr. HINCHEY. Could I ask—or has it run out? Have I run out? 

Ms. DELAURO. Yes, it has. Unfortunately we didn’t start the 

clock, Maurice, but you did go over. 

Mr. HINCHEY. But the clock varies from time to time, I see. 

Ms. DELAURO. No, the clock has been no guarantee. That is why 

I let you just let it go. 

Mrs. Emerson. 

Mrs. EMERSON. Madam Chair, can I yield a minute—no, a second 

of my time—no, a couple seconds of my time to Maurice? 

I just want to answer your question about what companies import Chinese products. Well, here you have smoked oysters, Haddon House Food Products, Inc., in Medford, New Jersey. Here are 

some nice smoked oysters for you. 

Oh, and here are Harris Teeter mandarin oranges. You missed 

this at the beginning, so I thought I should show you. Harris Teeter oranges, these are imported from China by Harris Teeter. 

Mr. HINCHEY. I am not interested in it from the point of view of 

being able to purchase it myself, you know. 

Mrs. EMERSON. Here is JFC International, Inc. This is dried seaweed. This is another Harris Teeter product. Oh, and then the best 

one. The best one are cooked noodles in who knows what kind of 

water. 

Simply Asia, and this company is called Simply Asia Foods, Inc, 

Union City Boulevard, Union City, California. So it is a lot of little 

companies. 

Mr. HINCHEY. I wonder who those little companies are connected 

to. 

Mrs. EMERSON. Harris Teeter probably does it on its own and 

other generic brands of groceries. 


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Oh, here is yet another one. Excuse me. Oh, this is just Harris 

Teeter. But, anyway, I just wanted to point out that I think it is 

probably fairly prolific. None of those are chicken products, by the 

way. There is some frozen shrimp and squid and octopus in that 

bag, too, but it is defrosted. I am not going to get it out. People 

may get too hungry. It is lunchtime. 

Mr. BROSCH. Just mention, Mrs. Emerson, that in the chicken 

import and export trade there are lots of small niche businesses 

that are involved in the import and export business. It is not dominated by the large companies. They are largely the producers and 

processors, and most of import export is by smaller niche companies. 

Mrs. EMERSON. Yes, I was going to make that point. 

Regardless, you may not want to eat that stuff. I don’t, but that 

is beside the point. But just to answer your question, since the bag 

of goodies was sitting here next to me, I thought I couldn’t resist. 

Mr. HINCHEY. I am not sure that is an answer to the questions 

that I was asking, but I think it is an interesting set of circumstances where you have a lot of small companies that are engaged in this. One of the questions is, who are these small companies, who are they associated with, what corporations are they entangled with and in what way, and what are the actual import-export circumstances that are going on? 

All of these things are very important. I thank you for bringing 

up the little packages, but there is an awful lot more information 

that has to come out here. 

Mrs. EMERSON. I am not disagreeing, but I am going to ask my 

question now. I am going to ask my question now, because I probably will run into yellow time here. 

My first question goes to you, Ms. Wallach, and I apologize for 

having been gone for 30 minutes, but I had something else I had 

to do. 

Obviously, you take aim in your testimony at the equivalency requirements in trade agreements and also are critical of USDA’s administration of this policy, and you recommend that we act to require that only food that meets our safety standards is eligible for 

sale in the United States. And I think that appears to me like a 

goal of requiring other nations to harmonize their regulations with 

ours. 

I do want to note that HACCP, just for example, when they came 

into effect in 1996 they had already been required in Europe, in the 

European seafood industry. And when they, the Europeans, adopted those regulations, it was even difficult for them to determine 

what U.S. equivalency would be and what the competent U.S. entity would be, whether it is Food and Drug Administration or USDA 

with whom they should negotiate. So while we have a safe food 

supply, we can’t claim to possess or quickly implement all the best 

food safety ideas, and a diversity of approaches probably isn’t bad, 

because we really care about the results at the end of the day. 

You do seem to raise important concerns regarding USDA’s interpretation and implementation of equivalency policy. It is very hard 

to see how meat samples that are gathered by private company employees could be as reliable as those gathered by government employees or how procedures changed from those originally evaluated 


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can apparently be grandfathered in. Are these problems that could, 

even if you don’t believe ideally, could they be addressed by tightening of administration policy, number one? 

And I know, for example, that you mentioned—I was told that 

while I was gone that you mentioned to Mr. Latham that our 

phytosanitary agreements do not require China to choose inspection locations. So could that also be fixed administratively? And are 

you aware of any upcoming decisions we should watch for that may 

provide insight into the way USDA will interpret the equivalency 

standard? 

Ms. WALLACH. I think the way forward is to do a rulemaking to 

establish a new FSIS policy for determining equivalence. I think 

that there are problems with the concept of equivalence. It has limits, as I lay out in my testimony, overall that cannot be overcome, 

even with the best policy. 

But it is also the case that we can get a heck of a lot closer to 

safe by having the right equivalence policy, which is why it is important to do a new policy if we are going to do equivalence determination, again, knowing that there are limits to what under that 

system you can do. 

One of the main benefit of pieces of policy space that exists is in 

the WTO sanitary and phytosanitary agreement there is no definition of equivalence. There is a requirement that in fact that the 

countries get to decide if the exporting country standards meet 

their standards, which is why you have this huge diversity of how 

it has been implemented by other countries. And USDA has been 

a little schizophrenic about this question, which is why we need 

new rulemaking. 

In their report on the concept of equivalence, USDA, there is a 

FSIS report that says meat and poultry and egg products exported 

from another nation must meet all safety standards applied to 

foods produced in the United States. That is what they say is the 

definition of equivalence. 

But in the actual regulation that established the current policy 

they say, the United States can no longer require countries wishing 

to export meat and poultry products to have inspection systems 

that are at least as safe as those of the U.S. 

Those are direct contradictions, and I would say the new rule has 

to have the first version be the version. 

Then the question becomes, if you look at the level of safety, the 

inspection system, the system of oversight, and the access to information in the system, are each of those systems delivering the level 

that is the U.S. level? And that is where we have had a major failure. Because we have had just clear—like, for instance, the U.S. 

standard requires continuous inspection, and we have held countries equivalent over and over and over, even though they don’t 

have continuous inspection. 

We require government inspectors, not company inspectors. We 

have allowed countries to stay equivalent. These are not like close, 

like hmm, is it the right pathogen test to do it this way or that 

way? These are just really obvious. 

So some of the things we have to do in a new regulation as well 

as making clear that what we are really looking for is there may 

be other ways to really be equal to us, that you don’t have to do 


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it exactly the same way but that you really have to get to our level, 

which is not the current system. 

In addition, we need to do things like have the equivalence determinations expire so that actually they get redone and there is a 

new rulemaking to make sure. To have a system basically when 

there are audits which need to be more frequent and funded. That 

when an audit fails the equivalence determination is suspended, 

the right to import is pulled until it gets fixed. The country then 

can say, come back, make sure it is fixed. Once it is fixed, it can 

be reinstated. 

Under the current system, audit after audit after audit finds the 

most horrific things; and not only is the equivalence not suspended 

but the right to actually export is not changed. Having the rule be 

that the U.S. inspectors decide which plants, once you have the 

system, then you still have the U.S. certifying particular plants, 

what the Japanese and EU are doing. Having more on-sight inspection, so it is not just an annual audit, please God, but on a regular 

basis you have inspectors going through the plants. Those are all 

ways you can certainly improve the current system. 

And as well having all these rulemakings on the record so that 

each country when they change a rule you have a new notice and 

comment, which, by the way, is what NHTSA does. The NHTSA 

process and also the substance, which explicitly says they give priority, actually, their exception to equal to is higher than, so that 

they look for an upward harmonization. So if another country is 

doing it better, smarter, higher standards, then we can accept that. 

And, in fact, the way that their rulemaking is done it calls on us 

to think about harmonizing to the other country. So it is a list-up 

system, and it is all done on the record. So, procedurally, it is more 

inclusive. 

Mrs. EMERSON. You told Jack that you would be a little bit more 

comfortable with Japan’s equivalency. Do you feel the same way 

about the EU? 

Ms. WALLACH. The reason why I hedged is because I don’t know 

on paper what it requires. What I know is what the reports are of 

how it is being implemented in China. 

I could review both of those systems and get back to you about 

what the actual system says. I just hadn’t done that homework. 

Mrs. EMERSON. If you don’t mind. 

Ms. WALLACH. I am happy to look it up. 

And, Mr. Kingston, Honduras and Nicaragua are importing meat 

under their equivalence determination. The meat man has informed us. 

Mr. KINGSTON. Any problems with it? Any illnesses? 

Mr. CORBO. Not that we know of. 

Mrs. EMERSON. I am at red. 

Ms. DELAURO. I want to thank Mrs. Emerson. 

I just wanted to say that the problems are worldwide. And, Mrs. 

Emerson, there was an FSIS inspection in 2003 of the Canadian 

system. The FSIS found it so bad they told the Secretary that public health was at risk. They recommended an enforcement review. 

The review was deferred by the Secretary, that FSIS work with the 

Canadians. 

Mrs. EMERSON. Referred? 


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Ms. DELAURO. Deferred, I am sorry. So that FSIS went back in 

2005 and they found largely the same problems. 

I will get the information to you on the Canadian issue, because 

I think it is important. This is not a singling out a place because—— 

Ms. WALLACH. The two Inspector General reports I would refer 

to your attention also that goes to the whole system. 

Mrs. EMERSON. Thank you. 

Ms. DELAURO. Mr. Farr. 

Mr. FARR. Thank you very much, Madam Chairman. 

This is a beautiful can of worms you have opened up. Listening 

to this I felt like we were talking, debating the Nuclear Arms Inspection Treaty, my guys will inspect your guys. And it seems to 

me that this raises so many questions that are worthwhile raised, 

and I do think we probably need to revisit it all. 

You have to keep in mind that all agriculture is grown somewhere or all poultry or cattle are raised somewhere. In most cases, 

that is in a county or in a State, not just in a country; and each 

of those regions have their own regulations. 

I was thinking about something we don’t grow in our country, so 

we don’t have that inspection process. But when you think about 

labeling fair trade coffee, it is not really much of an enforceable 

label. It is supposedly coffee that is grown in ecologically sensitive 

ways. It is supposed to pay their—and coffee growers are small, little, independent farms, just from my experience of being a Peace 

Corps volunteer in Latin America and Colombia where they grow 

a lot of coffee. It is supposed to pay the wages and benefits. That 

is a label that we all accept in this country. 

But we also have set up this kind of different process for food, 

because we put it in the Federal Government as a separate inspection for meat and poultry. We don’t have a Federal inspection for 

everything else. This is the only specialized inspection we have. 

And so, therefore, if you are going to get into it—and I have a 

lot of cattle operators now who want to grow and serve their own 

beef, just like they say their neighbors can grow grapes and process 

them and put them in a bottle and put the label on the bottle. It 

is very difficult to do that, to put it on meat, saying this is Jack 

Barion Ranch’s grass-fed cattle. And they want to do that because 

of all these issues on animal safety. Yet to get it into an inspection 

process and slaughtered in a slaughterhouse and keep your label 

on it versus trying to get a meat inspector to come down and watch 

a small slaughter, it is just not happening. 

So this is a whole market that I know Marcy is very interested 

in, in how do we develop this market on our own? So I think the 

difficulty in here is we get unintended consequences as we try to 

build the perfect sanitized system. 

Fresh produce, in my area, the most fresh produce in the world, 

Salinas Valley, most of it lettuce, you don’t have a kill step with 

lettuce. And what you have had is recalls on E. coli contamination, 

salmonella contamination. And guess what is happening? What we 

are seeing is that even with the best management practices in the 

world on how you grow this stuff safely you still have now the new 

sort of private sector coming in with their corporate risk managers 

saying to growers, you have to grow to our standards, have nothing 


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to do with science. And growers are having to kill every rodent, 

which is now hurting the wildlife population, particularly the 

raptors. And what they are finding is they are having to use more 

pesticides and herbicides because their integrated pest management systems are destroyed by these mandates from corporate, not 

from Federal. And yet if you are going to sell lettuce to McDonald’s, 

it buys a lot of lettuce, you want to make sure that you meet their 

standards. 

And I think when you get into other countries it gets more difficult. Because equivalency is supposed to be that you are as good 

as we are, and that is why we allow you to import stuff. 

I have dealt with how we in California put inspectors in Hawaii. 

When you get on a plane in Hawaii, you have to go through an ag 

inspector. California pays for that, because we don’t want those 

medflies coming back to California. 

So we have done this stuff where you put our people in other 

countries. They put their own inspectors on the ground in Holland. 

And, therefore, they know they are not going to get contamination 

coming into Japan. We are not even getting in. 

When you get into trying to do trade, what happens if a pest— 

like we have a glassy-winged sharpshooter. You cannot move that 

to any other State, can’t move it outside the country, because we 

have banned anything coming in. 

So this is really what it is, is a can of worms. How do you set 

these national standards, which I do think we ought to have, but 

still not put it away so that the small farmer—I think if you have 

these health standards that we are going to require for selling 

produce in a grocery store apply to the produce that is in the farmers market, you are going to kill farmers markets, because they are 

not going to be able to meet those standards. 

You know, I don’t think we have had many illnesses because people have bought food from farmers markets. 

So I would really be interested. Ms. Wallach, you said that in 

your paper here—I noticed the sentence that WTO equivalency rule 

shows U.S. law and agency regulations and practices must change, 

as well as trade agreement constraints on food safety. It is not only 

a matter of the agency’s doing better but changes to underlying 

policies. 

How do we meet those standards so that indeed—you know, we 

can’t just say—it is interesting. Why do we export so much poultry 

but not allow anybody to import? Because that is the trade deal. 

We are not going to allow our stuff into their country unless we 

take stuff from their country. That is just a fair deal. 

Now, they ought to be traded on equivalent standards. That is 

for sure. And if you are a country that is struggling, how—the laws 

in Mexico on food inspection are great, but the infrastructure for 

that, trying to hire people with those kinds of degrees and pay 

them the salaries they pay them in their Federal workforce or in 

their state workforce isn’t happening. And so there is stuff done 

under the table. 

So I am really concerned about do we sort of have to develop a 

training course and equivalency standard for professional ethics 

and professional standards and have kind of the world meet that 

if we are going it to import from those countries? How do we get 


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there from here? It is one thing to say, let’s just change these laws, 

but, as you pointed out, Ms. Wallach, these countries have some 

good laws; they just don’t have the ability to enforce them. How do 

we close that missing gap? 

Ms. WALLACH. Well, I think one of the best ways to try and not 

have the unintended consequences problems is—and there is three 

levels of change. There is the trade agreements, there is statutes, 

and the regulations. 

On the regulatory level, which gets to coming up with a new system for what the equivalence policy should be for USDA, doing it 

as an on the record rulemaking at least provides an opportunity for 

all the potentially interested parties to get their two cents in. As 

we saw with the organic standard, frequently tens of thousands of 

people get their two cents in. So that is a way where, unintentionally, some standard could be set that somebody who is on the 

ground producing would get in a comment that would be important. So that is one of the procedural questions. 

On the question of the difference in the infrastructure and the 

funding, that is part of what a new U.S. equivalence policy has to 

take into consideration. Right now, under the current policy, they 

do what is called a paper audit. And so there are some splendid 

systems. They are just not enforced. They are beautifully written. 

The problem is there are only a few plant audits, for instance, 

even with Canada where things are enforced. But we did 4 out of 

200 plants we looked at to see actually what was on paper, what 

was on going on in the plants. With China, you saw there were 

some 25 plus plants, considering there were actually 6 places that 

were looked at. 

So having a system where we actually, in determining not just 

what is on paper but what is happening, take into account is there 

a capacity. 

And, number three, having our inspectors certifying what plants 

means that if we are saying these three plants are the ones, then 

that is where the resources go. 

Mr. FARR. Do they do that here? For example, when they come 

to buy, foreign countries come to our country, do they come in and 

inspect our plants and select which ones so that their country decides, EU or Japan? 

Ms. WALLACH. It depends on the country. EU and Japan do go 

look at our plants. 

Mr. FARR. And they see whether those plants meet their standards. 

Ms. HAUTER. And Russia does. 

Ms. WALLACH. I don’t know about Russia. But EU and Japan, 

yes, they pick our plants. 

There is no violation of any trade agreement obligation. It is our 

bad past policy that explicitly said we would no longer do that. It 

is in the rule. So that is just one very clear thing we should 

change. 

Mrs. EMERSON. Will the gentleman yield? 

You asked the question of how often they come to inspect our 

plants? 

Ms. WALLACH. That I don’t know. I don’t know. I can try and find 

that out. 


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Mr. FARR. But what I am pointing out is there is also now another movement which is the private sector, this idea of we will 

have our own corporate inspections outside; we are not trusting 

government enough. And that is dangerous. Because then you are 

setting corporate standards that have no good science behind them, 

and you are going to ruin a lot of other—as I have seen in our area, 

you are essentially running in conflict with all of the best management practices you are taught about trying to grow things in an 

open environment. 

Mrs. EMERSON. Sam, that is a little bit of a generalization. We 

don’t know. Because there is liability that those companies, if they 

import bad stuff, so surely they have got to have some standards. 

Mr. FARR. Sure. But when they are coming and telling the growers in California, which probably has the toughest standards in the 

Nation on everything—pesticides, herbicides, farm worker practices, OSHA standards, all of that—that you have got to go kill/poison all of the rodents—and one Federal inspector was so shocked 

when they arrived in the Salinas Valley, saying, oh, my God, birds 

fly over these crops; we will have to prevent that. 

I mean, that is the kind of reaction that people are having now 

when they find contamination of E. coli and salmonella is because 

these products don’t have a kill step. I am pointing out it is all 

kind of convoluted, but it gets very complicated when you get down 

to the grower level of how you are going to meet these national or 

Federal or international standards that aren’t practical. 

Ms. WALLACH. The regulatory process I think can be dealt with 

that way. 

On the statutory level, in my testimony I recommend we go back 

to an equal to standard. I don’t think we had to change the statute. 

But even if we don’t, the agency can basically have a rule that requires that, as you put it, you are showing their stuff is up to our 

standards. 

And then the third thing is the trade agreements. There are 

issues beyond equivalence where the trade agreement sanitary, 

phytosanitary, and technical barriers to trade chapters rules actually do have constraints, not just on imported food safety but products, toys, other products; and those constraints were put in place 

under this notion of basically facilitation of trade volume over everything else. And that is out of balance. 

Mr. FARR. Do you have a paper on that? 

Ms. WALLACH. I do have a paper on that. 

And, moreover, you were a cosponsor last year of the trade act, 

the Trade Reform Accountability Development and Employment 

Act, that calls for renegotiation of the food safety and product 

standards language so that you basically have the balance. So we 

get the benefits of trade but that we don’t sacrifice the necessary 

safety. 

The basic principle of it is, if doesn’t discriminate, i.e., as long 

as you trade the foreign and the domestic good the same, it is not 

a trade issue. And we shouldn’t have trade agreements setting a 

subjective limit on safety. The question is discrimination, and then 

the question is done. 

And so that is the same issue with equivalence. If we had everyone treated the same, we wouldn’t really have a trade issue. 


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So that bill has been introduced again this year, and there are 

106 cosponsors, so it may have the hope of a review of the actual 

trade agreements in the renegotiations. 

Mr. FARR. Does that answer all these questions? I am not sure 

it does. We will talk about that later. 

Ms. DELAURO. Marcy Kaptur. 

Ms. KAPTUR. Thank you, Madam Chair, for a very, very interesting hearing. I had two other events I had to be at before this 

one, so I am sorry I couldn’t be here at the beginning. But I have 

read your testimony, and we thank you for being here. 

What runs through my mind is how, especially in the food arena, 

when something is said exactly the opposite actually occurs. So, for 

example, when we had the fight on labeling, and rather than labeling we get deceptions. So you will get a label that says, no cholesterol, real big letters. And then you look at the back, high in saturated fats. There it is, you know, 40 percent. How you get a 60 percent fat content in chicken pie, I can’t figure out how you can get 

it so filled with saturated fat. 

You think of the term NAFTA, North American Free Trade 

Agreement. It is anything but free. We have had over a trillion dollars of trade deficit racked up with both Mexico and Canada since 

its start, a trillion dollars. So many lost jobs, but we call it free. 

It isn’t free. It is very, very expensive. That doesn’t say anything 

about what has happened in Mexico or Canada. 

We talked about the word equivalency. It is actually not equivalent. 

So what you have to do when you get into the food arena is, 

whatever they say, just reverse it; and then you will begin to understand the truth. You will begin get to the truth. 

I grew up in a store, our family store. And our father, who was 

a small businessman, bless his soul, called our store Supreme Market. We used to wrap up the meat; and he would put his label on 

there, Supreme Market, address, name, phone number, everything. 

We were so proud of everything that was made there. 

And as I have watched what has happened over the period of 

time, I think what is missing in the food sector is true ethics accountability and the former American ethic, going back to the 

founding of the Republic, of great respect for the earth and its productive abilities. You can walk around these buildings and see 

women holding shafts of wheat, and as it became a more mechanized society the ethic was missing. Something has happened, and 

it is very serious. 

And when I look at this food safety issue and the importation 

issue, what you generally get is people don’t want labels. They 

don’t want to know. 

Those in charge of the food system today—and small grocers like 

our father were drummed out of business because of contracts that 

Maurice somewhat referenced—this is a true story—where dad 

used to go into Swift and Armor in those days, and I would go with 

him, and the man who was in the cooler would say you can’t have 

those anymore for your store because it was prime meat because 

the supermarkets have bought the whole case. So you can only 

have the choice meat, not the prime meat. 


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I remember our father’s face, probably one reason I am in Congress today, because I lived the inequity in our family. And thank 

God for the man in the case who said to our dad, hey, Kappy, it 

is okay. I will switch carcasses. They won’t know anyway. Our dad 

knew what the best was. 

But something has happened with the ethics of food, and it goes 

beyond any one regulation. It is the reason that as we talk about 

inspection somehow the mechanized system has made us forget our 

values. And I say that because of many of the interests represented 

in the audience today. We thank those who want to call us to a 

higher ethic. 

And maybe it is a restoration of the original ethic of stewardship 

and a respect for the earth and respect for people who produce our 

food—and I don’t want to get too religious, but in the denomination 

I am a member of the symbol of a table and breaking bread is very 

important. There is even a very serious religious element to all of 

this that somehow when we allow contaminated goods to flow to 

anyone’s table—and the more poor you are the more likely it is 

that contamination will flow to you—something is really wrong inside the system. No matter how profitable it is, if the ethics are 

missing, we have changed as a country, and it is not good. 

So my question really is to Mr. Brosch. It is my understanding 

that if a foreign food processor of meat in Mexico is sending goods 

here—we were told by USDA 11 companies, I guess, do that down 

there, 11 different plants—that we send our inspectors in there because there have been problems with Mexico and then those goods 

flow here. My question is, do you know who pays for the inspectors? Is there a fee on the importer to pay for those inspectors or 

do the taxpayers pay for that? I am very interested in that. 

Mr. BROSCH. I think this is paid by the taxpayer. I don’t believe 

this is a fee for service, but that is in the red meat area. There is 

no poultry coming from Mexico, and I am more familiar with the 

poultry situation. 

Ms. KAPTUR. Okay. I am concerned about equity here and the 

way in which we handle this whole food movement back and forth. 

In the area of invasive species, though that is not the subject of 

today’s meeting, but when we get contamination in this country, 

there is no international—this goes to my question, my second 

question, which is, if you looked at the amount of money we as taxpayers are having to pay for the mistakes, environmental mistakes 

happening inside this country—take my district, 10 percent—we 

have more trees than any other area of Ohio. We are going to lose 

10 percent of our tree cover, like that, from the emerald ash borer. 

And who is responsible? Nobody, nobody. So where does the bill get 

placed? On the taxpayer. I say that is wrong. 

So my question really is, what is the international claims court 

or torts court? Where do you take the importer, where do you take 

the exporter to get—I want my money back. For every tree, for all 

the money I have had to appropriate, for all the city governments 

who have to hire people to cut down and replant these trees, where 

do I get justice in this system? 

For the kids who got sick in Michigan eating those strawberries 

in those little yogurt things or Sundaes that they were eating up 

there when that came in from Mexico and was packaged in Los AnVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00226 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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geles, who went to court? Where is the court case? None. No ethics. 

No responsibility. No justice. What kind of a system is this? 

So my question to you is, you are here today on trade agreements 

and equivalency standards. But how do we get ahold of the whole 

enchilada and control those who are doing this at our borders? 

Jo Ann held up those products there. All right. So if something 

goes wrong—nothing ever went wrong in our dad’s store; nobody 

ever got sick. But if they had, they knew exactly where they got 

it. 

Now what is the system that we have today to assure that quality and that justice? Whether it is food or whether it might be 

invasive species, what is the mechanism internationally where we 

can get justice? Because it doesn’t exist right now. 

Ms. HAUTER. I don’t think we have one. 

Ms. KAPTUR. We don’t have one. Madam Chair, we are left with 

this regulatory—this Swiss cheese regulatory mechanism that 

doesn’t work and putting the burden on the taxpayer to pay for everything. It is a whacky, unjust system. 

Ms. DELAURO. Ms. Hauter, do you want to respond? 

Ms. HAUTER. I was going to respond generally. 

I think it is beyond the scope of this panel today, but I think we 

really need to do a complete assessment of our food system, from 

the way that the Farm Bill impacts small farmers, the concentration that is present in this country, the way that small farmers 

really can’t compete, even though we hear in their name that our 

agricultural policies are really all about helping family farmers. 

And I think that we need to promote the types of policies that are 

going to allow a more local food system. I know Congressman Farr 

mentioned someone in his district who is trying to slaughter on a 

very local basis. 

We have recently released a report on this issue where we assess 

the USDA regulations, and it is very difficult for any small producer to compete, whether they are trying to produce meat, cheese, 

or vegetables. And so what we really need is a shake-up and to 

really look holistically at the system. 

Now, I don’t have an answer for how that is going to happen, but 

that is the only way that we are going to straighten out our food 

safety system. 

Ms. KAPTUR. If you have proposals along those lines that you 

could share, we would be very interested in your ideas. 

Ms. HAUTER. We would be happy to do so. 

Ms. WALLACH. The only thing that I would add is that not only 

isn’t there such a system, but, in fact, the existing enforceable 

international government system is the trade agreements, which 

set an explicit ceiling on many of those issues of consumer justice. 

So not that I want to give the invasive species issue, get your 

blood boiling more, but in fact certain actions that the United 

States has taken to try and control various invasive species have 

been threatened with WTO attacks under the sanitary and 

phytosanitary agreement arguing that they are not the least traderestrictive means. And particularly the Asian long-horned beetle, 

we were going to require a particular kind of fumigation and temperature treatment of the pallets that come in the wood of the shipping pallets coming from Asia. And we got a demarche, which is 


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the first step to a WTO challenge, from China on behalf of Hong 

Kong, threatening that that wasn’t the least trade restrictive way 

to try and limit the invasive species infestation. 

And, in fact, our own USDA or APHIS I think had done the sort 

of testing of what could you do to allow the trade to continue but 

not have the pallets causes a serious problem and decided that was 

not just the least straight, that was the only way. It had to be a 

certain temperature, and it had to be zapped by a certain chemical. 

So we never implemented that. It was a threat, that we took the 

threat seriously and didn’t want the challenge. So—— 

Ms. DELAURO. Mr. Brosch, do you want comment? 

Mr. BROSCH. Yeah, we can’t do this here today. 

There have been a lot of statements about what the sanitary and 

phytosanitary agreement says and doesn’t say. I happen to be one 

of the two U.S. negotiators of this agreement, was involved in it for 

6 years. I would just like to state for the record that I wouldn’t 

agree with a lot of things that have been said about that. If we had 

a longer time and a different thing, we could have a debate on that. 

I know we don’t have that time. 

But I don’t believe that we ever intended during the negotiation 

to put a ceiling on the level of safety that any country could choose; 

and, in fact, it says that explicitly in the agreement. It says that 

any country can choose its appropriate level of sanitary or 

phytosanitary protection. And that is the core of that agreement. 

So I would have to disagree with that. I don’t think that is true. 

With respect to people threatening to sue us on least restrictive 

means, you know, as I say as a lawyer to my friends all the time 

who are worried about lawsuits, you can always be sued. The question is whether somebody can beat you or not. 

If that is the question, if in fact the facts are as represented 

there, I don’t think the United States should be afraid if somebody 

is threatening to sue. If we do get sued, we can defend that; and 

we have defended cases. I have personally defended cases for the 

United States. 

The last thing I would like to say is there have been a lot of 

things said about conspiracies or deals done within the Department 

to trade safety for food. And I was not at the Department in 2006 

when this occurred, but I was at the Department between 1989 and 

1999 and served under about five Secretaries of Agriculture and a 

number of under secretaries, served directly with them and was a 

negotiator in the Uruguay Round on agriculture and the SBS 

agreement and the NAFTA. 

I can tell you, Ms. Chairman—I would say this under oath—I 

was never once in a meeting where anyone suggested that we 

should trade benefit for safety. I have never heard that during my 

time in the Government. I just want to say for the good people at 

USDA who do their job every day, I think that that is, at least in 

my experience, not a correct assessment of the way they go about 

their business. 

Ms. WALLACH. I just want to address the ceiling/no floor issue, 

because it can be addressed on two different grounds. 

First of all, the only kind of standard—I think you will agree 

with me—that can be challenged is the domestic standard that provides a higher level of protection than is deemed appropriate in the 


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agreement. There is no mechanism for challenging the lack of a 

protection. There is no floor. The only thing that can get challenged 

is a higher level of protection, not the failure to provide some kind 

of a food safety protection. So when we say that prioritizes trade 

facilitation over safety, when there is only a ceiling, i.e. Being challenged for too high, not too low, that is pretty much only a ceiling. 

The second point is the provision you just read, was article sub 

1 of the basic rights and obligations, but if you keep going through 

the other three rights and obligations you get to the crux of what 

I was talking about, the least trade restrictive rule, which is members shall ensure that any sanitary or phytosanitary measures 

apply only to the extent necessary to protect human, animal, plant 

or health are based on scientific principles and is not maintained 

without sufficient scientific evidence. 

And then it goes on to continue to say, sanitary and 

phytosanitary measures which conform to international standards 

and recommendations shall be deemed to be necessary, but everything that doesn’t conform, i.e., everything that is higher, is subject 

to challenge. And, again, there is no way to challenge things that 

are lower, so thus the ceiling versus the floor. 

Ms. DELAURO. Mr. Kingston. What I will do is, Mr. Kingston, 

and I know Mrs. Emerson has one more question and do that, and 

then I have a few questions, and then we will try to move to winding down. 

Mr. KINGSTON. Ms. Hauter, you get money from Public Citizen 

right? 

Ms. HAUTER. No. 

Mr. KINGSTON. You don’t? I am looking at their Web page, and 

it lists usage of Public Citizen money, and it does list Food and 

Water Watch. 

Ms. HAUTER. We were a spin-off from Public Citizen. We get no 

funding from Public Citizen. 

Mr. KINGSTON. There is no relationship, but it is listed on the 

Web page. 

Ms. HAUTER. No, no formal relationship. We have a collegial relationship. Our program grew, and we are getting outside of the 

main mission of Public Citizen, and so we started another group. 

It is a 501(c)(3), its own funders. We have no financial relationship. 

Ms. WALLACH. If you are looking at our 990s, I believe in 2006 

we had to pay them out the remaining grants when they got their 

own bank accounts. They used to be a division of Public Citizen, 

and they spun out as an independent organization, but we still are 

their former mother ship. 

Mr. KINGSTON. I just want to bring that up. Because one of the 

previous questions was that somehow these small businesses are 

maybe puppets or front groups for the big, evil, large businesses. 

And I just want to say—I am looking at it. 

And I want to also go on to say, since you asked, that I am disappointed. After telling you I voted with you on some trade agreement, your political donations, Al Franken for Senate, American 

Votes, American Civil Liberties Union, American Association of the 

University of Women, Common Cause, Democrats for the Future, 

Democrat Congressional Camp Committee, the Democrat National 


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Committee, Harry Reid for Senate, Hope Fund, League of Women 

Voters, Levin for Senate—I am looking for Kingston—Obama—— 

Ms. WALLACH. That doesn’t happen to be this Lori Wallach, because I don’t make enough to give those kind of contributions. 

Mr. KINGSTON. It is not your Web site. It is Public Citizen’s. 

Ms. WALLACH. We don’t have a PAC, so we don’t give any contributions. Now I personally am too broke. Were I interested in giving those contributions—you will find I did support Donna Edwards. 

Mr. KINGSTON. You are a group that was nonprofit, founded by 

Ralph Nader in 1971, correct? 

Ms. WALLACH. Uh-huh. 

Mr. KINGSTON. I am just going off your Web page. I am disappointed that you guys—— 

Ms. WALLACH. We don’t have a PAC is what I am telling you. 

We are a (c)(3) and a (c)(4). 

Mr. KINGSTON. Do you do things for these groups? I will show 

you this Web page. 

Ms. WALLACH. Yeah, I would be interested in seeing that, as 

would our general counsel. 

Ms. DELAURO. Jack. 

Mr. KINGSTON. And the only reason why I am saying that is because there were questions about some—Mr. Brosch had listed in 

the back of his testimony their groups. And so, you know, if he has 

a prejudice or a bias we can say, well, it is obviously Monsanto or 

National Retail Federation or National Turkey Federation that he 

is pushing for. 

But I am just trying to figure out if there is a relationship there 

or not, and you said there isn’t. I am just saying the Web page says 

there is. I will take your word for it, because I respect it as accurate. 

Now, let me ask you, Mr. Brosch, there have been some questions about our trust of Canada and our trust of the EU and our 

distrust of China. Why is that accurate or inaccurate? Should we 

trust China? 

Mr. BROSCH. Well, I think that we trust Canada and the European Union because the process that we have put into place has 

gone forward and our scientists and our regulators have taken a 

look at those countries. There have been questions raised by the 

chairwoman about Canada and about—— 

Ms. DELAURO. Continue. 

Mr. BROSCH [continuing]. About situations with Canada. We 

send the people back there. They work with those folks. We send 

people to Europe all the time. Mostly they send people here, the 

Europeans; and we work with those on a regular basis. 

I think it is that process that essentially improves the product 

you get or don’t get. You make decisions during that process 

whether you are going to allow that trade to continue, you are 

going to allow certain plants. As plants get delisted, you go take 

a look at them. That process goes forward. 

We don’t have that kind of experience with China. China has developed something of a reputation with respect to other products, 

not necessarily meat and poultry but milk and Melamine and other 


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products, and that has spilled over now, and people are painting 

with a broad brush. 

As I said, the Europeans and Japanese, the people we are talking 

about and the people we trust or trust us, are importing poultry 

from those countries. So I think it is a matter of process, and it 

seems to me we set up a scientific process. We have regulators we 

hopefully can trust— 

Mr. KINGSTON. Let me ask you, Ms. Wallach. You had said to 

Mr. Bishop earlier that we don’t have the system that Japan has 

in place. You said you are not quite sure what Europe has in place, 

but you would agree that we could learn from what Europe is doing 

if they don’t have a track record. Well, if they have a track record 

for good or bad, we can learn from that, correct? 

Ms. WALLACH. I think that they, looking at the same circumstances in China, decide they needed their own on-site inspectors, special days to run their export lines, and a very high 50 to 

70 percent border inspection to me indicates that they found problems and that was one way they thought they could deal with it 

to try and make it safe. I think we should learn from that experience. 

By the way, I will send you Public Citizen’s 990s. We don’t take 

any corporate or government money. We have 100,000 members, 

and we get a little bit of foundation money for books. 

Mr. KINGSTON. That is what your Web page says, and it actually says something very impressive: Your average donation is $28. 

That is good. 

I am not disputing that. I am just saying that information came 

from the Web page, that it suggested there was a relationship, lists 

a relationship. 

The only thing I want to point out is that Mr. Brosch has his 

members listed, and I think it is always good to know who is related to who. 

Now, let me ask you this. Ms. Wallach had talked about an annual audit and the right to look back and close down and keep up 

with new technology. In your opinion, is your group supportive of 

those? That sounds reasonable to me, frankly. Would you guys be 

supportive of that? 

Mr. BROSCH. An annual audit of the—— 

Mr. KINGSTON. Of a Chinese facility. 

Mr. BROSCH. Oh, I believe that they do that now, Congressman. 

Mr. KINGSTON. They do do that now? 

Mr. BROSCH. FSIS regular—— 

Ms. DELAURO. Not all of—they don’t look at all of the plants. 

Mr. BROSCH. I don’t know if they look at all of the plants, but 

they have an annual or nearly annual audit of the system of the 

country that we are dealing with. 

Mr. KINGSTON. Ms. Wallace, do you know what risk-based inspection is? 

Ms. WALLACH. Uh-huh. 

Mr. KINGSTON. Do you support that? 

Ms. WALLACH. I think there are elements of concern where the 

highest points of risk are, but I don’t support the program that has 

been played with here, that has been tested here. 

Mr. KINGSTON. Do you support the concept of it? 


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Ms. WALLACH. I think that you can emphasize what are the 

riskiest practices and places to look. For instance, yes, I support 

elements of it. The way FSIS has been doing reinspection at the 

border used to be based on what particular facilities and counties 

had the worst record. So you would know, boy, that plant has been 

having problems. I am going to do more of that. They went to a 

random sample system, which to me was crazy. So while the rest 

of the system was going to risk—yeah. 

Mr. KINGSTON. Internationally, could a concept like that be helpful in a situation like this where you have stated you have a little 

more comfort level with Canada than you would with China? 

Would a risk-based inspection approach work? 

Ms. WALLACH. I think that one of the things about redoing the 

regulations is taking into account the different levels of infrastructure and funding available in different countries. Because one of 

the big failings now is you have a paper audit that looks at what 

the laws are in the book, but then you have no idea if they are actually implemented. So I don’t know if that would be risk or reality 

based. 

But, for instance, in a country that has very limited funding or 

a culture of having a lack of government accountability or secrecy 

of reporting problems, et cetera, I would be much more interested 

in having, for such a country to get the right to import, to have lots 

of U.S. inspection and oversight on the ground, as compared to a 

country that is having—for Canada, I would rather focus on the E. 

coli standards and less about that particular issue. 

Mr. KINGSTON. Also, one thing I wanted to mention—I know I 

am out of time and, Ms. Hauter, you want to say something. 

You know, if I could get a local farmer to produce and sell it to 

the local school board, one of the barriers in keeping him from 

doing that are many of the regulations that Ralph Nader groups 

have supported. And it is very frustrating. Because I know I think 

from reading that you prefer locally grown food, and I think many 

of us do. But I know one of the huge problems in the local farmers 

selling to the local school board are regulations that have been 

thrust upon the market, really because of litigation and things. 

And I would love to work with a group like yours to say, okay, how 

do you get a local farmer to sell to a local school board and get 

around some of those regulations that are burdening him and prohibiting him from it. But I don’t know if we can get there at this 

point, because there is so much litigation that our society is in love 

with right now. 

Ms. WALLACH. Needs to be updated just like the international 

standards need to be updated. 

Ms. HAUTER. Congressman, we would love to give you the report 

that we just published on small slaughter and what needs to be 

done in a regulatory framework to make local slaughter possible. 

I also just want to say about risk-based inspection that the National Academy of Science just found that there is not the data 

available to show that risk-based inspection works, and we have a 

lot of concerns about the way that it would be implemented. 

Mr. KINGSTON. You know, I haven’t read that report but look forward to it. I can say this, having some knowledge of the food business since I used to sell product liability insurance and I have sold 


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to food processors, that there are certain processors that have violations just as there are restaurants that have more violations than 

others. And if you have an inspector that has 4 hours I would rather have him go to the frequent violator than somebody who has a 

really strong track record. And that is what risk-based inspection 

is. 

But I am not pushing risk-based inspection right now. We have 

had some good hearings on that. I can’t even believe he is still sitting here. 

But my question really was, if you trust Canada and Europe, 

does an international risk-based inspection that would go after the 

Chinese shoring up their program work? 

Mr. BROSCH. Mr. Kingston, about your local production, there is 

under FSIS rules a 20,000 bird exemption for small local production. So if someone is a producer of less than 20,000 birds a year, 

he can, he or she, whoever is running that business can do that 

and be outside the FSIS inspection system; and the rationale is 

that person is selling locally and all of their customers know where 

they are getting their product. 

Ms. DELAURO. Mrs. Emerson. I think you had one question. 

Mrs. EMERSON. I actually have one and a half. 

Ms. DELAURO. Go for it. 

Mrs. EMERSON. Just because, since we have got off the subject 

of Chinese chicken, sort of, I do have one question I want to ask 

of Ms. Wallach and then a general question that I would like each 

of you all to answer. 

Back on phyto and phytosanitary, in your written testimony you 

mention the EU’s ban on artificial growth hormones in meat and 

the millions that they have had to pay in WTO, because of the adverse WTO finding. I am just curious. In your opinion, was that a 

necessary food safety regulation or was it protectionism? 

Ms. WALLACH. I think it is the right of the people who are going 

to eat the food to decide the standard. So the test for trade should 

be did they apply the same standard domestically as they sought 

to apply to imports. So at the point that they actually had successfully banned it, because that wasn’t the case in the first couple of 

years, the same artificial growth hormones for their own producers, 

then their consumers have a right to expect the same for the product in the market that is coming from an imported source. So I believe that was legitimate when it became non-discriminatory, and 

they maintained their right to do that by paying the sanctions. 

Mrs. EMERSON. Okay, I appreciate that. 

Tomorrow, we have before us a new food safety bill; and we are 

going to vote for it under suspension of the rules in the House— 

pardon? 

Ms. DELAURO. That is not clear. 

Mrs. EMERSON. Oh, I thought that was what we were doing. 

Let’s forget that we might vote for it under suspension. 

Can I just get your all’s take? Have we done enough with regard 

to USDA and with regard to the FDA and will any of the things 

that we have discussed today be helped by that food safety bill? 

Because I want to make sure that we are going to be in a position where some of the equivalency and the like, that we are actually addressing all of those things, if we are going to take it up. 


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Because I think we have to do something. Obviously, today’s hearing would point that out. But I want to know what we are doing 

is on the right track. 

Mr. BROSCH. I apologize. If I had known you would ask that 

question, I would have prepared for it. 

Mrs. EMERSON. Well, I didn’t know I was going to ask it. Since 

we went off Chinese chicken, I figured I might as well ask. 

Mr. BROSCH. I am not really prepared to answer that question. 

Ms. WALLACH. I am in the same boat. 

Ms. HAUTER. We would have much preferred the legislation that 

Congresswoman DeLauro had introduced. 

Mr. KINGSTON. Hear hear. 

Mrs. EMERSON. We would agree with you. I was just wondering. 

Ms. HAUTER. We have concerns about this legislation, although 

we are not generally opposing it. We are hoping that some of these 

concerns are worked out. The fees on small farmers, less—too much 

regulation on small producers. The bill does, however, increase vigilance on imports for FDA. It is just going to be very costly. 

Mrs. EMERSON. We can find the money. We should make 

sure—— 

Ms. HAUTER. We would be happy to give you our written assessment of the bill. 

Mrs. EMERSON. Well, if you can give it to us today. 

Ms. HAUTER. We can. 

Mrs. EMERSON. Thank you. Maybe when you get back to your office. 

Ms. HAUTER. Okay. 

Ms. DELAURO. Yes, I think the authorizers have got to come to 

the Appropriations Committee to deal with the funding to carry out 

what it is they have talked about carrying out. 

I know Mr. Bishop doesn’t have any more questions. I have three 

and a half, and then we truly will wrap up. You all have been wonderfully patient with us. 

Under the system approved by FSIS, China will only be able to 

deal with processed chicken that originates largely in the United 

States or Canada. Let me just ask the three of you—and it is a 

quick question. How will we be able to tell if what is shipped back 

is exactly the same product that was sent to China, especially since 

we will not have U.S. inspectors in the Chinese plants? And how 

do we know whether the product is cooked to the appropriate temperature in order to assist with that process of safety? 

Ms. HAUTER. We won’t. 

Ms. DELAURO. Ms. Wallach. 

Ms. WALLACH. We won’t. 

Mr. BROSCH. It will be based upon a series of records and an 

audit of records, as I understand it. That is how that process 

works. So it is based upon a review of records, of in and out, shipments in, shipments out, and the time in which they do the processing, how they run the lines. 

Ms. DELAURO. And to know that we have—not getting a domestic poultry product in return, because, as you know, domestic Chinese poultry is still prohibited to the United States because of high 

incidents of Avian flu. 


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Mr. BROSCH. The rule doesn’t allow it. That is I think the basic 

legal restriction of the rule. It doesn’t allow use of anything except 

poultry from approved—— 

Ms. DELAURO. And given the level of inspections we have on the 

ground there, that we can, both in terms of inspections and of cooking the product to the appropriate temperature, your view is that 

we will be able to address that. 

Mr. BROSCH. I think that FSIS could address that. They are not 

here, again, but I think they are the people who will have to answer your question. 

Ms. DELAURO. Okay. 

Ms. WALLACH. As far as the temperature, we would have to rely 

on, under an equivalence determination, whatever system is going 

on in China that we are deeming to say is okay. And this would 

be a question, if you had more inspectors on the ground, if you 

would actually be able to stay on top of that. 

As far as the prospect of chicken laundering, bringing in one 

source and recruiting another one, I think that would be something 

that would be very hard to avoid, even given the potential of tracking the paper. I think that is almost impossible to avoid. Which 

begs the question of if you have got a phytosanitary reason why 

you are very nervous about having a particular product, i.e., an 

animal illness, do you ever allow then a processed chicken stem 

from that place until the actual animal disease is controlled? 

Ms. DELAURO. A recent CDC report found that poultry was the 

most commonly identified source of food poisoning in the United 

States. That was recounted in the newspapers in an article by 

Gardner Harris, I think, on June 12. I think it was in the New 

York Times. And I have spoken to food safety scientists at CDC 

and others about the key issues involved in assuring poultry products are safe, and the most important factor they cite is maintaining correct temperatures throughout. 

This is a particular challenge for China. Let me quote from a 

USDA publication that was released this month. It is entitled Imports From China and Food Safety Issues. Refrigerated storage and 

transport equipment in China is relatively scarce. When temperature-controlled infrastructure is available, power outages, railroad 

delays, and delivering temperature standards may lead to spoilage. 

Is such a system equivalent to ours? Are these reasonable risks 

for us to take with American consumers? Mr. Brosch? 

Mr. BROSCH. Well, I think the first information you had, that 

poultry was the food most associated with food-borne illness may 

be a little bit distorted. My understanding that that data that is 

based on two outbreaks in two prisons, where they had a substantial number of incidents in those prisons, and that there is, in fact, 

further data on that study that sort of corrects that. So my recommendation is we will try to get you some information on that, 

but I think that that is not quite accurate. 

Ms. DELAURO. The temperature issue, can you address that? 

Mr. BROSCH. Yes, I think what we have got is a situation where, 

if China is approved and China is allowed to do this, what we will 

have is a limited number of plants near the ports who are going 

to be the ones who will source this. They are going to be the ones 

closest to receive the product coming in. 


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By the way, we don’t anticipate there is going to be a lot of trade 

in this. The idea of bringing poultry all the way from the United 

States to Canada and then being able to process it and bring it 

back is going to be a very small amount of trade. Probably a specialized item like a Chinese specialized food item or something like 

that, but we don’t anticipate that they are going to be near the borders. Those are going to be the plants that are already processing 

for Japan and for Europe. I don’t think we are going to see plants 

that are far away from the borders or away from the main part of 

the industrial heartland of China providing chicken under this 

plan. 

Ms. DELAURO. That is interesting. That is not something that we 

had heard about, bringing, you know, stuff from the ports and industrial. 

So, in any case, let me just ask—well, go ahead, please. I didn’t 

ask you, Ms. Wallach. 

Ms. WALLACH. I was going to say if that is potentially the safest 

way to do it, then that should be part of the rule that would be 

the equivalence determination. This gets more to the idea of thinking about where the risks are and then having specific determinations for specific countries. And I say that as a person who knows 

trade and not the technical details. But having just heard that for 

the first time to translate it to what the equivalence policy would 

be, you then would want to make that the rule. Because, otherwise, 

the way things are now, China decides which plan. 

Ms. DELAURO. That is right. 

Ms. Hauter. 

Ms. HAUTER. And this speaks to the problem of having a very decentralized regulatory system, where local authorities make a lot of 

decisions and where we are certifying that the whole country is 

safe, rather than the way that Europe does it, looking at different 

regions. 

Ms. DELAURO. Yes. This was, again, an ERS report, July, 2009, 

Imports From China and Food Safety Issues. I talked about what 

was on one page now. This is page 17 of that report. 

Most of the violations flagged by FDA and imports from China 

over the annualized periods were problems linked to the processing 

and handling of food products, rather than to farm production practices. Filth generally results from introducing dirt or foreign materials and unsanitary packing or processing of facilities. 

Page 45, exported products often bring a higher price than those 

sold on the domestic Chinese market because of the higher costs 

of strict safety controls and the large differential between domestic 

and rural prices. Because the difference in prices is so wide, producers have strong incentives to sell inferior products for export 

produced at lower costs with fewer safety controls, which creates 

a challenge in policing supply chains to ensure that unsafe products are excluded. 

The last comment I want to make from the report, which is at 

page 26, which refers to a publication called The China Price by 

Alexandra Harney; and the quote is, the difficulty of conducting reliable company audits in China is highlighted by Harney’s description of, quote, shadow factories, sophisticated strategies to falsify 

records, and other means of evading audits by foreign customers. 


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I think those come out of a USDA ERS publication, which I believe gets at the heart of what today’s issue is about, not only about 

China but the whole issue of equivalency and where we go for the 

future. 

I wanted to address a beef issue, if I might. I don’t know if anybody wants to comment on those comments. I think they speak for 

themselves. 

Again, this is a China-U.S. poultry dispute. It is Jeffrey Baker, 

Congressional Research, July 16, 2009. It says here, and I quote, 

China is the only market completely closed to U.S. beef exports and 

represents one of the largest potential growth markets for U.S. 

beef, worth in excess of $100 billion. 

Mr. Brosch, can you tell me why we haven’t taken China to the 

WTO over this? 

Mr. BROSCH. I don’t know. I think that the closing of the beef 

market had to do with a couple of limited incidents of Mad Cow 

that were picked up in the northwest part of the United States. 

There has been a lot of back and forth with the Chinese on this, 

and—I don’t know—maybe Ambassador Kirk in his statement recently that he plans to increase enforcement, maybe that is what 

he will be looking at. 

Ms. DELAURO. But I am interested, because you represent a coalition of a whole group of people who have a significant interest in 

the beef market here. Why hasn’t the U.S. brought suit or a complaint of the WTO if this is—and I have no reason to dispute CRS 

here. 

Mr. BROSCH. No, I don’t dispute that. 

Of course, you can’t bring a private right of action in the WTO. 

Our groups could not file a lawsuit at the WTO. It is a countryto-country agreement actions have to be brought by the U.S. government. 

Ms. DELAURO. Well, that is what I am asking. I mean, this is not 

a group without sufficient clout, if you will. 

Mr. BROSCH. Well, I can tell you, for example, we think that 

poultry has been unfairly excluded from South Africa for about 10 

years; and I have personally been in to see, I think, every person 

in the world; and I still haven’t been able to get the U.S. Trade 

Representative to take that case. 

Ms. DELAURO. Do you think we should? Your view, do you think 

we should? 

Mr. BROSCH. Well, actually, the one group I don’t represent is the 

beef people. So I don’t know what discussions they have had, but 

perhaps so. But it is a frustration a lot of times when you try to 

get those decisions made. 

Ms. DELAURO. Okay. I have one more question, but I think Ms. 

Kaptur does. I will ask my question, and then it is the end, guys. 

Ms. KAPTUR. Madam Chair, I don’t know if anyone has asked 

this question or not, but I wanted to ask Mr. Brosch or the other 

witnesses, which food chain in the United States sells the most imported Chinese chicken, to your knowledge? 

Mr. BROSCH. Nobody, because we don’t have any imported Chinese chicken. 

Ms. KAPTUR. We have none. Prior to the ban? 


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Mr. BROSCH. We never have had any. They banned it before 

there was any imports. So we don’t have any Chinese chicken. 

Ms. KAPTUR. So we have never had imports of Chinese chicken 

into our country. 

Mr. BROSCH. Not to my knowledge. 

Ms. KAPTUR. Even before the ban. All right. 

And I wonder if any of our witnesses have any information about 

the incidence of the swine flu. In fact, I was at the University of 

Wisconsin recently and heard that there is a theory that flies in lagoon pits east of Mexico City related to a very large swine production facility may actually be the nexus of the carrier from the lagoon pit to children that live here there. Have you had any confirmation of this or could you provide anything to the record? 

Ms. HAUTER. We have heard that theory; and we can provide you 

with what we have seen, mostly news articles. 

Ms. KAPTUR. But I was at a meeting with very high-level researchers where they had traced everyone who had left the country 

and then anybody that got the swine flu around the globe, and 

then they traced it back to this particular area. I believe it was 

east of Mexico City. 

I remember when we had the NAFTA fight, and we said that 

meat production would be moving south of the border. And people 

said, oh, that could never be done, because they don’t have enough 

water and so forth. There is a million animal hog-producing platform down there, and the question is whether or not this can be 

linked. So I would appreciate any information that you have. 

Ms. HAUTER. There are also other issues related to the illness. 

There are E. coli bacteria, not the 0157, that also cause illness; and 

ARS has written about this. They are present in imported meat 

products. And these are bacteria that aren’t currently in the U.S. 

And so this is another consideration. Because we don’t test for 

these pathogens domestically, we can’t test meat products of our 

trade partners, and this is something that needs to be addressed. 

Ms. KAPTUR. You know, it is interesting, Madam Chair, the supermarket that I shop at on occasion back home, I noticed in the 

supermarket’s case just in the last 6 months or so the meat that 

is now on there, if it is labeled, will have a label that says from 

U.S., Mexico, or Canada. So I assume under NAFTA one cannot 

identify the country but only the trade agreement. Could anyone 

comment on that? 

Mr. BROSCH. Well, there is a complication with respect to 

NAFTA trade, because there are movements across—especially in 

the Texas area and on the Canadian border there is movement of 

small animals. For example, you may have a breeder operation in 

Canada where they will sell—they will be born, and then they will 

sell small animals across the border. Then the question is, is that 

an animal that is Canadian or American? And I think the rules say 

that it has to be completely born, raised, and fed, or something like 

that. So if you have got the movement of small breeding animals 

across the border, then you have a hard time identifying either as 

Canadian or American. 

And then also there is a movement of breeder animals from the 

United States across the border into Mexico, and there is a big 

business in that. So it is a very difficult thing to do that with reVerDate Nov 24 2008 07:08 Apr 27, 2010 Jkt 055703 PO 00000 Frm 00238 Fmt 6601 Sfmt 6602 E:\HR\OC\A703P2.XXX A703P2

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spect to NAFTA countries because of that particular movement on 

the border. 

Ms. KAPTUR. Very, very interesting. Thank you. 

Mr. KINGSTON. I wanted to ask one more question at some point. 

Ms. DELAURO. All right. Why don’t you go ahead. 

Mr. KINGSTON. I wanted to ask, are you guys familiar with we 

moved catfish from FDA to USDA? Does that concern you? Do you 

want to react? 

Mr. CORBO. Tony Corbo from Food & Water Watch. 

We were opposed at the time of moving it over because of the 

staffing shortage problems that FSIS had just dealing with meat, 

poultry. And I have been quoted as saying they had a tough 

enough time doing four-legged animals; they don’t need fins as 

well. 

But the issue now that it is over there, and you all have already 

appropriated, you know, money for the program to be set in motion, 

that I think we are going to have to go through the program and 

set up a system for domestic catfish inspections so that it could 

also be applied to the imports. And so we see this as an opportunity to really assess. Because we are importing an awful lot of 

seafood and we are importing a lot of catfish and a lot of it is showing up with illegal antibiotics, that FSIS may have an opportunity 

here to get control of the unsafe imports that are coming into this 

country. 

Mr. KINGSTON. Well, let me ask you this. It was actually moved 

because of trade, not because of food safety; correct? 

Ms. DELAURO. Yes. 

Mr. CORBO. The Catfish Farmers of America, they were the ones 

who successfully got it moved over. And I agree with you. There 

were trade arguments used. 

But in looking at the data from FDA in terms of what they have 

been able to intercept, they are not getting it all. You have products coming into this country from Vietnam and from China and 

from Thailand that do not meet our food safety standards. And so 

if we are—— 

Mr. KINGSTON. We will have the equivalency standard though, 

right? 

Mr. CORBO. They will have to set up a system. FSIS will have 

to set up a system. And what is remarkable about this language 

in the farm bill is that not only will the processing facilities have 

to meet the inspection standards, but it also gives FSIS on-farm inspection capabilities and transportation inspection capabilities, 

which we don’t have for meat and poultry now. 

Ms. DELAURO. I would just add there, I was in conversation 

when we were doing the farm bill with catfish farmers. I told them 

I wasn’t sure—actually, I was more than not sure; I didn’t think 

it was such a good idea. But we did put in very tough language to 

try to deal with this, you know. What we did and one of the big 

issues with regard to trade was the percentage of the market that 

was being taken by foreign imports, and the foreign imports were 

coming in just laden with antibiotics. 

I refer you to yesterday’s, I don’t know if it was The New York 

Times or the Washington Post, but I think it was The New York 


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Times that talked about salmon coming in from Chile, and the 

salmon from Chile is loaded with antibiotics. 

Now, there, again, if we begin to change our standards and do 

what we want to do, you know, that can—I mean, again, the level 

of the agreement, I don’t know what it is specifically with that— 

we then are in a weakened position to deal with trying to protect 

the public health of this country. But I think it has been laid out 

as to what has happened with regard to catfish. 

Done. 

Mr. KINGSTON. Yes. 

Ms. DELAURO. I think it is important, and Ms. Kaptur is not 

here, but, again, processed foods are excluded from country of origin labeling requirements. 

So I think we need to reiterate that fact. 

Also, one of the points I wanted to make with regard to the 

science and a prior question here is and, again, this was science 

and from CDC and others, with U.S. chickens, and this is a quote, 

are fragile, easily contaminated with bacteria. It also says that 

every step increases risk. It is kill, clean, gut, getting it to the consumers. You need to do it as quickly as possible; and, in fact, it is 

crucial with regard to temperature. If the appropriate temperature—and keeping it that way. 

It is hard for me to believe. I would be less than honest if I didn’t 

express my view on this, that getting U.S.-Canadian chicken, getting it to China and maintaining a level of temperature, getting 

there, what happens there with the processing and defrosting and 

what happens there, who knows how it is being cooked. We are not 

even sure, two out of three are not sure, that the process—that we 

are getting back a U.S. or a Canadian chicken, coming back here. 

This is science. This is not some coming out of the door, out of 

the closet saying, okay, I think today we will look at this process, 

Chinese chicken, and say that, you know, it can put us at risk in 

terms of health. So that is science, and it is risk-based. 

Last question. This is, Ms. Hauter, you shared, I think, what is 

an interesting piece of information from ARS Research, that, and 

I quote, strains of food-borne pathogens not common to the United 

States are contaminating meat and poultry products that are imported. 

Can you just discuss the research findings on that or get us the 

research findings in more detail and get us a summary of that research? Because, I suspect that has health implications. Do you 

know if FSIS is taking this research into consideration in its 

equivalence determinations? If not, should it? 

I was interested in your statement that you have a document 

from FDA that says, and I quote, that half of the foods that have 

been associated with food-borne illness have been imported. And 

can you submit us a copy of that statement from the FDA for the 

record? 

Ms. HAUTER. Yes, we are happy to submit that. We had to sue 

to get it, but we now have the information, and we will provide it. 

Ms. DELAURO. Great. 

Ms. HAUTER. We can also provide the other information. FSIS 

also had a public meeting on the issue of the other types of bacteria. 


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[The information follows:] 


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Ms. DELAURO. Great. Let me just say a thank you to all of my 

colleagues, those who are here who hung in to the bitter end, and 

to the ranking member, who I know cares deeply about these 

issues, and Mr. Bishop as well, and those who had to go to other 

meetings today. 

I want to thank each of our panelists. Thank you for your knowledge and intellect and your candor and the suggestions about how 

we move to the future. 

I think we laid out some information, but, ultimately, it is about 

how we move to proceed for the future, which we all have an interest in. And I would love to be able to, you know, after this meeting, 

collect ideas of how we might try to deal with the issue of the Chinese chicken in the short term and also how we deal with equivalence and how this can lead us to equivalence in the long term. 

So I thank you all very, very much. 

Mr. KINGSTON. And I also wanted to say, you know, those Chinese products I am cooking them in my office, and I wanted to invite Tony and Dr. Raymond to co-host a little brunch with me, and 

we will have some good eating. 

Ms. DELAURO. I hope you are not alone, Jack. Thank you very 

much. 

This hearing is completed. Thank you. 


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W I T N E S S E S 

Page 

Brosch, Kevin ........................................................................................................... 141 

Cochran, Norris ........................................................................................................ 65 

Hauter, Wenonah ..................................................................................................... 141 

Henry, Craig ............................................................................................................. 1 

Levinson, D. R .......................................................................................................... 1 

McGarey, Patrick ..................................................................................................... 65 

Nudelman, Jodi ........................................................................................................ 1 

Sharfstein, J. M ....................................................................................................... 65 

Stenzel, T. E ............................................................................................................. 1 

Wallach, Lori ............................................................................................................ 141 


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hsrobinson on DSK69SOYB1PROD with HEARING
(III) 

I N D E X 

Page 

Food Safety Oversight: U.S. Department of Health and Human Services Office of Inspector General ................................................................... 1 

Access to Records .............................................................................................. 50 

Authority to Request Records .......................................................................... 43 

Bioterrorism Act ............................................................................................... 26 

Choice of Product Sample ................................................................................ 44 

Commingled Agricultural Products ................................................................. 42, 46 

Communication Protocol for Recalls ............................................................... 52 

Competent Handling of FDA ........................................................................... 32 

Compliance with Current Regulations ........................................................... 45 

Cost for Interoperable Systems ....................................................................... 35 

Criminal Liability-Based Investigation .......................................................... 49 

Definition of Interoperability ........................................................................... 35 

Difference in Minnesota Experience ............................................................... 48 

Enforcement ...................................................................................................... 28 

European Union ................................................................................................ 36 

Exclusions in the Bioterrorism Act ................................................................. 41 

FDA Authority to Request Records ................................................................. 36 

FDA Funding Levels ........................................................................................ 31 

Food Imports ..................................................................................................... 41 

Funding Levels ................................................................................................. 29 

Good Agriculture Practices .............................................................................. 52 

Imported Food ................................................................................................... 40 

Increase in FDA Funding ................................................................................ 39 

Industry Educational Efforts ........................................................................... 37 

Interaction with State Agencies ...................................................................... 38 

Lot Specific Information ................................................................................... 25 

Multiple Agencies ............................................................................................. 47 

New Statutory Authority ................................................................................. 50 

New York Times Article Submitted for the Record—‘‘Investigators Find 

Sources of Many Foods Untraceable’’ .......................................................... 56 

Ongoing Work with FDA Food Issues ............................................................. 54 

Opening Statement Chairwoman DeLauro .................................................... 1 

Opening Statement, Craig Henry ................................................................... 20 

Opening Statement, Ranking Member Kingston ........................................... 3 

Opening Statement, Daniel Levinson ............................................................. 4 

Opening Statement, Thomas Stenzel .............................................................. 12 

Other Records ................................................................................................... 45 

Peanut Corporation Recall ............................................................................... 58 

Progress on Mandatory Regulations ............................................................... 51 

Questions Submitted by Congressman Kingston ........................................... 60 

Recordkeeping Requirements .......................................................................... 33 

Saved Time ........................................................................................................ 34 

Sharing Responsibility for Traceability .......................................................... 55 


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IV 

Food Safety Oversight—Continued 

Small, Organic Growers ................................................................................... 51 

Statutory Authority .......................................................................................... 25 

Strengthening Traceability through the Supply Act ..................................... 27 

Technology for Recordkeeping ......................................................................... 34 

Third-Party Audits ........................................................................................... 43 

Traceability Priorities ...................................................................................... 42 

Traceability Regulations .................................................................................. 28 

Training Inspectors .......................................................................................... 44 

Voluntary Recall and Reimbursement ............................................................ 59 

Voluntary Vs Mandatory Recall ...................................................................... 32 

Written Statement, Dr. Craig Henry, Senior Vice President for Science 

and Regulatory Affairs, Grocery Manufacturers Association .................... 22 

Written Statement, Daniel Levinson, Inspector General, U.S. Department 

of Health and Human Services .................................................................... 7 

Written Statement, Thomas Stenzel, President and CEO, United Fresh 

Produce Association ...................................................................................... 16 

Food and Drug Administration ........................................................................ 65 

510K Process ..................................................................................................... 123 

Audits ................................................................................................................ 118 

Budget Request ................................................................................................. 69 

Cigarettes ...................................................................................................... 110, 111 

Control Measures ............................................................................................. 115 

Counterfeit Drugs ............................................................................................. 108 

Dietary Supplements ........................................................................................ 122 

Domestic Products ............................................................................................ 106 

E. Coli ................................................................................................................ 103 

Equivalency ....................................................................................................... 116 

FDAAA .............................................................................................................. 100 

FDA’s Budget .................................................................................................... 85 

FDA Hiring Plans for Veterinarians ............................................................... 90 

FDA Management ............................................................................................ 83 

FDA Staffing ..................................................................................................... 86, 94 

Flu Outbreak .................................................................................................... 71 

Food Safety ....................................................................................................... 120 

Food Safety Working Group ............................................................................ 102 

FTE .................................................................................................................... 92 

Generic Drugs ........................................................................................... 88, 98, 114 

HACCP .............................................................................................................. 116 

Heparin .............................................................................................................. 108 

Imported Shrimp .............................................................................................. 95 

IND Applications .............................................................................................. 91 

Industry ............................................................................................................. 113 

Industry Influence ............................................................................................ 83 

Introductory Remarks, Dr. Joshua Sharfstein ............................................... 67 

Legislative Initiatives ....................................................................................... 70 

Louisville Inspections ....................................................................................... 90 

Medical Devices ................................................................................................ 123 

Medical Product Inspections ............................................................................ 121 

Off Label Marketing ......................................................................................... 119 

Protecting America’s Food Supply .................................................................. 69 

Public Health .................................................................................................... 109 

Public Health Outcomes ................................................................................... 68 

Questions Submitted by Representative Boyd ............................................... 134 

Questions Submitted by Representative Farr ................................................ 125 


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V 

Food and Drug Administration—Continued 

Questions Submitted by Representative Latham .......................................... 136 

Recovery of Industry ........................................................................................ 105 

Risk Communication ........................................................................................ 105 

Safe Medical Products ...................................................................................... 70 

Scientists ........................................................................................................... 84 

Shrimp Imports and Field Exams ................................................................... 96 

Single Food Agency .......................................................................................... 120 

State Inspections .............................................................................................. 117 

State Partnerships ............................................................................................ 117 

Supply Chain Safety ......................................................................................... 108 

Tanning Beds .................................................................................................... 111 

Third-Party Certification ................................................................................. 106 

Tomatoes ........................................................................................................... 112 

Unobligated Funds ........................................................................................... 89 

UPS Hub at Louisville ..................................................................................... 91 

User Fees................................................................................................... 87, 98, 114 

Veterinary Medicine ......................................................................................... 89 

Written Statement, Dr. Joshua Sharfstein, Principal Deputy Commissioner and Acting Commissioner, FDA ....................................................... 73 

Protecting the Public Health in a Global Economy: Ensuring That 

Meat and Poultry Imports Meet U.S. Standards ...................................... 141 

Written Statement, Kevin Brosch, DTB Associates, LLP ............................. 149 

Written Statement, Wenonah Hauter, Executive Director, Food & Water 

Watch ............................................................................................................. 186 

Written Statement, Lori Wallach, Director, Public Citizen’s Global Trade 

Watch ............................................................................................................. 164 

Æ 


hsrobinson on DSK69SOYB1PROD with HEARING