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S. HRG. 111–231 

EXAMINATION OF FEDERAL FOOD SAFETY 

OVERSIGHT IN THE WAKE OF 

PEANUT PRODUCTS RECALL 

HEARING 

BEFORE THE

COMMITTEE ON AGRICULTURE, 

NUTRITION, AND FORESTRY 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

FEBRUARY 5, 2009 

Printed for the use of the 

Committee on Agriculture, Nutrition, and Forestry 

( 

Available via the World Wide Web: http://www.agriculture.senate.gov 

COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY 

TOM HARKIN, Iowa, Chairman 

PATRICK J. LEAHY, Vermont 

KENT CONRAD, North Dakota 

MAX BAUCUS, Montana 

BLANCHE L. LINCOLN, Arkansas 

DEBBIE A. STABENOW, Michigan 

E. BENJAMIN NELSON, Nebraska 

SHERROD BROWN, Ohio 

ROBERT P. CASEY, Jr., Pennsylvania 

AMY KLOBUCHAR, Minnesota 

KIRSTEN GILLIBRAND, New York 

MICHAEL BENNET, Colorado 

SAXBY CHAMBLISS, Georgia 

RICHARD G. LUGAR, Indiana 

THAD COCHRAN, Mississippi 

MITCH MCCONNELL, Kentucky 

PAT ROBERTS, Kansas 

MIKE JOHANNS, Nebraska 

CHARLES E. GRASSLEY, Iowa 

JOHN THUNE, South Dakota 

MARK HALVERSON, Majority Staff Director 

JESSICA L. WILLIAMS, Chief Clerk 

MARTHA SCOTT POINDEXTER, Minority Staff Director 

VERNIE HUBERT, Minority Chief Counsel 

(II) 

(III) 

C O N T E N T S 

Page 

HEARING(S): 

Examination of Federal Food Safety Oversight in the Wake of Peanut Products Recall ............................................................................................................. 1 

Thursday, February 5, 2009 

STATEMENTS PRESENTED BY SENATORS 

Harkin, Hon. Tom, U.S. Senator from the State of Iowa, Chairman, Committee on Agriculture, Nutrition and Forestry .................................................. 1 

Chambliss, Hon. Saxby, U.S. Senator from the State of Georgia ........................ 2 

Klobuchar, Hon. Amy, U.S. Senator from the State of Minnesota ...................... 15 

Panel I 

Khan, Ali S., Rear Admiral, M.D., Assistant Surgeon General and Deputy 

Director of the National Center for Zoonotic, Vector-Borne, and Enteric 

Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia ....... 7 

Sundlof, Stephen, M.D., Director, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Rockville, Maryland; accompanied 

by Michael Chappell, Acting Associate Commissioner for Regulatory Affairs, 

U.S. Food and Drug Administration ................................................................... 4 

Panel II 

Dewaal, Caroline Smith, Director, Program on Food Safety, Center for Science 

in the Public Interest, Washington, DC ............................................................. 28 

Hubbard, William, Former Senior Associate Commissioner for Policy, Planning, and Legislation, U.S. Food and Drug Administration, Chapel Hill, 

North Carolina ..................................................................................................... 30 

Meunier, Gabrielle, Mother of Affected Child, South Burlington, Vermont ....... 26 

APPENDIX 

PREPARED STATEMENTS: 

Dewaal, Caroline Smith ................................................................................... 48 

Hubbard, William ............................................................................................. 59 

Khan, Ali S. ....................................................................................................... 74 

Meunier, Gabrielle ............................................................................................ 85 

Sundlof, Stephen ............................................................................................... 88 

DOCUMENT(S) SUBMITTED FOR THE RECORD: 

American Frozen Food Institute, prepared statement .................................. 100 

Grocery Manufacturers Association, National Association of Manufacturers, National Confectioners Association, National Fisheries Institute, 

National Restaurant Association, Produce Marketing Association, 

Snack Food Association, prepared statement ............................................. 104 

QUESTION AND ANSWER: 

Harkin, Tom: 

Written questions for FDA .............................................................................. 108 

Casey, Robert P., Jr.: 

Written questions for Stephen Sundlof, Ali S. Khan, William Hubbard 

and Caroline Smith DeWaal ........................................................................ 109 

Page

IV 

Grassley, Charles E.: 

Written questions for Stephen Sundlof and William Hubbard ..................... 110 

Stabenow, Debbie A.: 

Written questions for William Hubbard, Stephen Sundlof and Caroline 

Smith DeWaal ............................................................................................... 111 

Dewaal, Caroline Smith: 

Written response to questions from Hon. Debbie Stabenow ......................... 113 

Written response to questions from Hon. Robert P. Casey, Jr. .................... 115 

Hubbard, William: 

Written response to questions from Hon. Charles E. Grassley .................... 117 

Written response to questions from Hon. Debbie Stabenow ......................... 117 

Written response to questions from Hon. Robert P. Casey, Jr. .................... 120 

Khan, Ali S.: 

Written response to questions from Hon. Robert P. Casey, Jr. .................... 123 

Food and Drug Administration: 

Written response to questions from Hon. Tom Harkin ................................. 126 

Written response to questions from Hon. Charles E. Grassley .................... 128 

Written response to questions from Hon. Debbie Stabenow ......................... 129 

Written response to questions from Hon. Robert P. Casey, Jr. .................... 130 

(1) 

EXAMINATION OF FEDERAL FOOD SAFETY 

OVERSIGHT IN THE WAKE OF 

PEANUT PRODUCTS RECALL 

Thursday, February 5, 2009 

U.S. SENATE, 

COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY, 

Washington, DC 

The committee met, pursuant to notice, at 10:04 a.m., in room 

216, Hart Senate Office Building, Hon. Tom Harkin, Chairman of 

the committee, presiding. 

Present or submitting a statement: Senators Harkin, Leahy, 

Casey, Klobuchar, Chambliss, and Johanns. 

STATEMENT OF HON. TOM HARKIN, U.S. SENATOR FROM THE 

STATE OF IOWA, CHAIRMAN, COMMITTEE ON AGRICULTURE, 

NUTRITION AND FORESTRY 

Chairman HARKIN. The Senate Committee on Agriculture, Nutrition, and Forestry will come to order. 

Good morning, and I welcome everyone to this hearing. I hope 

you will forgive me, but I will skip the niceties and get right to the 

point. I am nothing short of outraged at the increasing number of 

outbreaks of foodborne illnesses in our country. Everything from 

spinach and lettuce and peppers to beef products and now peanut 

products has been implicated. Within the last year, we had the biggest recall ever under USDA jurisdiction. In the last month, with 

the recall of peanut products from the Peanut Corporation of America, we have had one of the largest recalls ever under FDA jurisdiction. 

To say that food safety in this country is a patchwork system is 

just giving it too much credit. Food safety in America has too often 

become a hit or miss gamble. That is truly frightening. When 

Americans can’t count on the safety of basic items, like peanut butter that goes into our kids’ sandwiches that they take to school— 

look at a jar of peanut butter. I mean, what could be more ubiquitous? I mean, everyone has this on their shelf. I do at home. I 

still have peanut butter and jelly sandwiches, and it is good for 

you. Peanuts are good for you. It is a healthy food. And when we 

can’t even depend on that, that peanut butter that we put in our 

kids’ sandwiches that they take to school, that that is not safe, 

then we have to ask, what is? 

It has almost come back to the point where before we had truth 

in packaging, it was always buyer beware. We are almost to that 

2 

point now in food where it is eater beware. Beware of what you eat. 

You are on your own. 

The Centers for Disease Control and Prevention tells us there 

are 76 million cases of foodborne illness annually in the U.S., resulting in 325,000 hospitalizations and 5,000 deaths. That is not 

my figure, that is the Centers for Disease Control and Prevention. 

This is intolerable in the United States of America. 

Now, reducing the instances of foodborne illness in this country 

means examining every step in the food safety process. Our systems for tracing tainted products and removing them from commerce must be stronger, better coordinated, faster, and more efficient. Regardless of the level of contamination, we need to be able 

to identify the source accurately and promptly and act quickly. 

However, as in all of health care, prevention of the illness is the 

key. Prevention is much less costly than the treatment. So we must 

focus on getting the food safety done right in the first place, before 

the pathogens get into the food and they need to be recalled. 

Bear in mind this is not only a health issue, it is also an economic issue. It is inevitable that demand for the food crop that is 

involved in the outbreak will fall sharply. During a recall, retailers 

lose business. Processors lose customers. And, as we all know and 

as I am sure our Ranking Member, Senator Chambliss, knows all 

too well, farmers suffer, as well. Entire communities can face economic devastation, as I think we will hear about this small community in Georgia. 

We have got to come up with a better, smarter approach to food 

safety. We have got to make the investments both in better systems and in putting more inspectors on the ground. It is about the 

integrity of our food supply. It is about the health and wellness of 

our people and the protection and safety now of our children who 

eat peanut butter. Who would have thought, peanut butter? 

So our goal this morning is to explore what went wrong. What 

do we need to do to get things right? This is under the jurisdiction 

of our committee and we intend to pursue it. 

Now, we have a distinguished panel of witnesses. I look forward 

to your best counsel on how we can do a better job of preventing 

outbreaks. I am not an expert in this. I am not a veterinarian. I 

am not a doctor. I am not an epidemiologist. But something has got 

to be done and we need the best information possible on what to 

do, first on prevention, and second, when outbreaks happen, how 

can we do a better job of stopping them early before they spread. 

So with that, I will now turn to my friend, my Ranking Member, 

Senator Chambliss. 

STATEMENT OF HON. SAXBY CHAMBLISS, U.S. SENATOR FROM 

THE STATE OF GEORGIA 

Senator CHAMBLISS. Thank you very much, Mr. Chairman. Last 

year, it was tomatoes. Today, it is peanuts. Next week, it may be 

some seafood. But you are exactly right. We have a system that is 

flawed and a system that in this particular instance has once again 

failed consumers across America. 

I am pleased to see you with this jar of peanut butter here, because coming from a State that grows almost 50 percent of the peanuts that are grown in America, we want to make sure that every 

3 

consumer that walks into the store and buys a peanut product can 

have the comfort of knowing that product is safe, and frankly, it 

is not just with peanuts, but it is with every product on the shelf. 

We are seeing now that has been called into question. 

It just so happens this jar of peanut butter is totally safe. Under 

the testimony that you will hear today, the issue of salmonella that 

has caused serious problems around the country came from one isolated facility and went into a number of products around the country. But a jar of peanut butter like this or Peter Pan or whatever 

it may be is totally safe. 

Not only do we have a failure in the mechanisms of detecting 

foodborne illnesses, but we have a flawed system of educating the 

public about products, as well. So I am very pleased that in today’s 

hearing, it is an important step to help members of this committee 

examine the various roles of Federal and State officials and the responsibilities of private food manufacturers in ensuring that our 

food supply is safe. 

Clearly, there are lessons to be learned from this latest salmonella outbreak from a peanut processing plant in my State of 

Georgia. While I understand that today’s government witnesses 

may be limited in some responses due to the ongoing criminal investigation, I do hope that we can identify how to better coordinate 

the Federal, State, local, and private sector response to a food safety situation. Our goal is to put in place the most effective tools to 

protect the American consumer and to put confidence in the marketplace where it is lacking today. 

An effective public-private sector partnership is critical to ensuring a safe food supply. The private sector has the responsibility to 

follow Federal guidelines and ensure the safety of their products. 

The Federal and State governments have the responsibility to oversee these efforts and take corrective actions when necessary. We 

need to quickly identify gaps in the system and act swiftly to correct them. 

The current salmonella outbreak could prove to be one of the 

largest in our history. The fact that a contaminated product was 

ultimately used as an ingredient in hundreds of other products has 

challenged our food safety system to a new degree. 

I appreciate the FDA and CDC witnesses for sharing their 

knowledge and initial reactions to this situation with us today and 

I look forward to continued collaboration with their agencies as we 

move forward to develop and implement improvements to protect 

our food supply. 

I want to extend a special thank you to Ms. Meunier for appearing before the committee today to share her family’s personal experience. I read her testimony and I applaud her efforts to bring tangible recommendations to Congress. They are practical and they 

are common-sensical, things that simply make almost too much 

sense that the bureaucracy has a difficult time comprehending. 

I look forward to working with the pertinent Federal and State 

agencies, private industry, the scientific community, and citizens as 

we strive to achieve the common goal of maintaining a safe, affordable, and nutritious food supply that all Americans can enjoy, and 

I thank you, Mr. Chairman, and look forward to the testimony 

today. 

4 

Chairman HARKIN. Thank you very much, Senator Chambliss. 

I just want to, again, before we introduce our panel here, I just 

want again to reassure parents across the country that the peanut 

butter that they buy in these jars, whether it is Skippy, Jiffy, or 

what was that other one you said? 

Senator CHAMBLISS. Peter Pan. 

Chairman HARKIN. Peter Pan, of course, all those are safe. These 

are safe, and if anyone disagrees with me, say so, but I believe that 

is factual. You don’t have to worry about it. I will even eat my own 

peanut butter sandwich while I listen to the witnesses just to show 

you that I don’t have any fear of eating peanut butter. 

[Laughter.] 

Chairman HARKIN. Let me now turn to our first panel. We have 

Dr. Stephen Sundlof from the FDA Center for Food Safety and Applied Nutrition. He was appointed Director of this Center January 

7 of 2008. He provides the executive leadership to the Center’s development and implementation of programs and policies relative to 

the composition, quality, safety, and labeling of foods, food color 

and additives, dietary supplements, and cosmetics. In the 14 years 

preceding this, Dr. Sundlof served as Director of FDA’s Center for 

Veterinary Medicine. Before that, he was a professor at the University of Florida College of Veterinary Medicine. 

We have Rear Admiral Ali S. Khan, M.D., currently Assistant 

Surgeon General and Deputy Director of the National Center for 

Zoonotic, Vector-borne, and Enteric Diseases from the Centers for 

Disease Control and Prevention. He joined the CDC and the U.S. 

Public Health Service Commissioned Corps in 1991 and has been 

with them ever since. 

And we have—I am sorry, you will have to introduce Mr. Chappell. I don’t have a bio on Mr. Chappell. 

First, I have all your testimonies. They will be made a part of 

the record in their entirety. I would ask if you would sum it up in 

about 5 minutes or so, maybe seven, but around that timeframe so 

we can get into a discussion with all of you, and I will start with 

Dr. Sundlof and then we will go to Rear Admiral Khan. 

Dr. Sundlof, welcome and please proceed. 

STATEMENT OF STEPHEN SUNDLOF, M.D., DIRECTOR, CENTER 

FOR FOOD SAFETY AND APPLIED NUTRITION, U.S. FOOD 

AND DRUG ADMINISTRATION, ROCKVILLE, MARYLAND; ACCOMPANIED BY MICHAEL CHAPPELL, ACTING ASSOCIATE 

COMMISSIONER FOR REGULATORY AFFAIRS, U.S. FOOD AND 

DRUG ADMINISTRATION 

Mr. SUNDLOF. Thank you, Mr. Chairman and Senator Chambliss. 

As you indicated, I am Dr. Stephen Sundlof, the Director of the 

Center for Food Safety and Applied Nutrition at the U.S. Food and 

Drug Administration, which is part of the Department of Health 

and Human Services, and I am accompanied today by Michael 

Chappell. Michael is FDA’s Acting Associate Commissioner for Regulatory Affairs. FDA appreciates the opportunity to discuss the ongoing investigation of the foodborne outbreak associated with Salmonella Typhimurium, which has been found in peanut products 

produced by the Peanut Corporation of America, and I will refer to 

that as PCA from here on out. 

5 

In a typical traceback process employed by the FDA and our 

partners at the Centers for Disease Control and Prevention or 

CDC, they notify FDA when it identifies the possible foods associated with a foodborne illness outbreak through its epidemiological 

investigation, and it is at that point that the FDA starts its investigation to identify the source of contamination. In the current 

case, FDA started its tracing process before the CDC notified us of 

the strong epidemiological link, both to help inform the epidemiological study and to shorten the time period required to get the potentially contaminated food off of the market. 

Since December of 2008, FDA has collaborated with CDC and the 

Food Safety Inspection Service of USDA and public health officials 

in various States to investigate a multi-State outbreak of human 

infections due to Salmonella Typhimurium. Peanut butter was first 

identified as one of several possible sources in mid-December. 

On January 7 and 8, based on conversations with the CDC, Food 

Safety Inspection Service, and the Minnesota Department of 

Health about preliminary epidemiological data, FDA decided to 

begin to investigate institutional food service sources of peanut butter rather than to wait for more conclusive data. And on January 

8, based on the preliminary information from CDC’s multi-State 

case control study, FDA made its initial contact with the King Nut 

Company in Ohio. King Nut distributes peanut butter manufactured by PCA to institutional facilities, not supermarkets or retail, 

but to institutional facilities, food service industries, and privatelabel food companies in several States. 

On January 9, FDA initiated an inspection of the PCA manufacturing plant in Blakely, Georgia. As part of its epidemiological investigation, the Minnesota Department of Health tested an open 

five-pound container of King Nut peanut butter obtained at a nursing home where three patients were sickened by the outbreak 

strain of Salmonella Typhimurium. And by January 10, Minnesota 

officials had found that the peanut butter contained the same 

strain of Salmonella Typhimurium associated with the illness 

linked to the outbreak. However, because it was an open container 

which could have been contaminated by someone or something else 

in the environment, these results did not conclusively confirm that 

the Blakely plant was the source. 

So FDA expanded the testing of unopened containers of the same 

brand of peanut butter, and on January 19, testing by the State of 

Connecticut Health Department of an unopened container of King 

Nut peanut butter showed that it contained the same strain of Salmonella Typhimurium associated with the illnesses linked to the 

outbreak. The fact that Salmonella Typhimurium was confirmed in 

an unopened container of peanut butter indicated that the peanut 

butter was contaminated when it left the plant in Blakely, Georgia. 

As I noted earlier, FDA had already initiated the inspection of 

PCA’s Blakely plant on January 9. FDA completed its inspection on 

January 27 and FDA’s environmental sampling of the plant found 

two salmonella strains, but neither of these were the outbreak 

strain. We are confident, however, that based on the investigations 

by the States, CDC, and the FDA, that the Blakely plant is the 

source of contamination related to the Salmonella Typhimurium 

outbreak. Further, FDA’s review of the firm’s testing records reVerDate Nov 24 2008 13:33 Mar 03, 2010 Jkt 000000 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 C:\DOCS\49576.TXT SAG2 PsN: SAG2
6 

vealed that there were instances in 2007 and 2008 where the firm 

distributed product in commerce which had tested positive for salmonella. 

The first recalls began on January 10 by the King Nut Company 

and on January 13 by PCA. PCA’s most recent recall began on January 28, 2009, when the firm issued an expanded voluntary recall 

of all peanut products processed in its Blakely facilities since January 1 of 2007, including the following products: Dry and oil-roasted 

peanuts, granulated peanuts, peanut meal, peanut butter, and peanut paste. Many companies that received peanuts and peanut products manufactured by the PCA’s Blakely facility have, in turn, conducted voluntary recalls. 

FDA is continuing to work with the purchasers of PCA’s peanut 

and peanut products to identify affected products and facilitate 

their removal from the market. FDA initiated inspections of the direct consignees of PCA and King Nut and continues to follow the 

distribution points for products. FDA and State officials have contacted hundreds of firms throughout the entire distribution chain 

that may have purchased or further distributed PCA products. 

We would like to emphasize that the major national brands of 

peanut butter in jars found in grocery stores are not affected by the 

recall, as Senator Chambliss has already pointed out. Further, 

FDA has no evidence suggesting that the contamination originated 

in any manufacturing facility other than the PCA Blakely plant. 

That facility is no longer operating at this time. 

FDA has established a webpage to provide constantly updated information on the contamination and recall. It includes a searchable 

data base to assist consumers in quickly identifying recalled products. FDA encourages consumers to check this website to determine 

which products have been recalled and continue to check that as 

new recalls appear. 

In closing, let me assure you that the FDA is working hard to 

ensure the safety of the food supply in collaboration with its Federal, State, local, and international food safety partners and with 

industry, consumers, and academia. In the current outbreak, FDA 

acted expeditiously to determine the source of the contamination 

and to identify affected products to facilitate the removal from the 

marketplace. 

Although the Salmonella Typhimurium foodborne illness outbreak underscores the challenges that we face, the American food 

supply continues to be among the safest in the world. Food safety 

is a priority for the new administration. 

Please be aware that FDA is actively conducting both criminal 

and regulatory investigations related to his matter. To protect the 

integrity of these ongoing investigations and any related actions 

that might be pursued in the future, FDA must necessarily keep 

certain information confidential. Further, it is premature for FDA 

to draw conclusions about its preliminary observations or how 

FDA’s legal authorities might apply to those observations. But that 

said, we will do our best to respond to any questions that you may 

have. 

Thank you again for the opportunity to discuss these important 

public health matters. 

7 

[The prepared statement of Dr. Sundlof can be found on page 88 

in the appendix.] 

Chairman HARKIN. Thank you very much, Dr. Sundlof. 

Now we will turn to Admiral Khan. Admiral Khan, welcome to 

the committee and please proceed. 

STATEMENT OF REAR ADMIRAL ALI S. KHAN, M.D., ASSISTANT 

SURGEON GENERAL AND DEPUTY DIRECTOR OF THE NATIONAL CENTER FOR ZOONOTIC, VECTOR-BORNE, AND ENTERIC DISEASES, CENTERS FOR DISEASE CONTROL AND 

PREVENTION, ATLANTA, GEORGIA 

Admiral KHAN. Good morning, Chairman Harkin, and thank you 

for the invitation to address the committee today. I am Ali Khan, 

an Assistant Surgeon General and Deputy Director of the National 

Center for Zoonotic, Vector-borne, and Enteric Diseases at CDC. 

As the nation’s prevention agency, CDC leads the Federal efforts 

to gather data on and investigate foodborne illnesses and outbreaks 

and to monitor the effectiveness of prevention and control efforts. 

CDC depends on our critical partnership with State and local public health departments and our very close collaborative relationship 

with FDA and USDA to get this work done. 

Salmonella is a group of bacteria that is widespread in the intestines of reptiles, birds, and mammals, and it is the most common 

cause of bacterial foodborne disease in the United States. The current outbreak is caused by the most common type of salmonella, 

Salmonella Typhimurium, which causes about 15 to 20 outbreaks 

each year. 

On November 10 of 2008, CDC began to monitor a small, highly 

dispersed, multi-State cluster of 13 cases of Salmonella 

Typhimurium with an unusual laboratory pulse fingerprint, something that we call the PFGE fingerprint, and those 13 isolates were 

reported by 12 States to PulseNet, and PulseNet is our national 

network of public health and food regulatory agencies that is used 

to detect foodborne disease outbreaks. 

On November 25, the cluster had increased to 35 isolates reported from 16 States and was subject to increasing investigation. 

Beginning in early December, this cluster was combined with another laboratory cluster of 27 cases in 17 States that was shown 

also to be the same salmonella using better laboratory tools. These 

combined clusters were then joined for an intense investigation and 

communication during December into early January that usually 

starts with numerous interviews to suggest the likely food item or 

common exposures followed by these detailed epidemiological studies of these food items. 

The early epidemiologic evidence suggested an association with 

peanut butter served in institutions as a possible explanation for 

at least a part of the outbreak. Salmonella was isolated from an 

open container of King Nut peanut butter in Minnesota, and the 

outbreak strain of Salmonella Typhimurium was isolated from a 

previously, as you heard, unopened five-pound container of King 

Nut creamy peanut butter in Connecticut. 

However, ongoing interviews indicated that many cases actually 

did not eat peanut butter in an institution but had eaten various 

other peanut-containing products. To better determine the associaVerDate Nov 24 2008 13:33 Mar 03, 2010 Jkt 000000 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 C:\DOCS\49576.TXT SAG2 PsN: SAG2
8 

tion of illness with other peanut butter-containing products, a second large study was conducted by CDC in collaboration again with 

its partners between January 17 and 19 to assess these exposures 

in these non-institutional settings, and preliminary analysis suggested looking at people who were ill compared to people who 

weren’t ill showed that they had actually eaten specific brands of 

prepackaged peanut butter crackers, and these both brands of peanut butter crackers were made at one plant which is known to receive peanuts from PCA. 

As of yesterday, we have had 575 persons from 43 States and one 

person from Canada who have been infected with this outbreak 

strain. We have had reported onset of illness starting from September 1 of last year until January 22 of this year. A total of 127 

people have required hospitalization, and the infection may have 

tragically contributed to the death of eight persons. 

The epidemiologic, laboratory, and traceback findings from this 

continuing investigation indicate that peanut butter and peanut 

paste produced at PCA are the source of this outbreak. More specifically, the outbreak was caused by contaminated peanut butter 

used in institutions and by peanut butter and peanut paste used 

as ingredients in food products. So we call this an ingredient-driven 

outbreak in which a contaminated ingredient can affect many different products that are distributed through various channels and 

consumed in various settings. 

The outbreak appears to be slowing, but we will not be able to 

know that for sure at this point. Because of the natural time lapse 

in reporting, it will be two to 3 weeks after it ends before we can 

actually tell you the end of the outbreak. 

In conclusion, this event illustrates how a large and widespread 

outbreak can occur from distribution of a single item into hundreds 

of foods. It also highlights the continued need for robust disease 

and detection response systems at all levels, local, State, and Federal to really enjoy that prompt recognition, response, and investigation into outbreaks. 

CDC will also continue its efforts to focus on research, education, 

and training that will assist with strategies to prevent foodborne 

illness before they happen, incorporate the food industry into our 

prevention, response, and information sharing activities, and really 

help bolster the State public health infrastructure to effectively and 

promptly identify and respond to these outbreaks. We are prepared 

to continue to work with regulatory authorities, State and local 

partners, food and environmental microbiologist scientists, and the 

food industry to find long-term solutions to prevent foodborne disease and limit those that do occur. 

Thank you again for the invitation to testify before you today. I 

will be happy to answer any questions you may have. 

[The prepared statement of Ali S. Khan can be found on page 74 

in the appendix.] 

Chairman HARKIN. Well, thank you very much, Dr. Khan and 

Dr. Sundlof. We will open our first round of questions here. 

Dr. Sundlof, news reports indicate that FDA is increasingly relying on contracts with State agencies to carry out the responsibilities of FDA, such as inspection of facilities like those of the Peanut 

Corporation of America. If I have it correct, according to the WashVerDate Nov 24 2008 13:33 Mar 03, 2010 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 C:\DOCS\49576.TXT SAG2 PsN: SAG2
9 

ington Post, FDA last inspected that Blakely, Georgia plant in 

2001, that is, last inspected it before January of this year. Is that 

correct? 

Mr. SUNDLOF. The plant was inspected by FDA inspectors in 

2001, but FDA does have contracts with the State of Georgia to 

conduct investigations on our behalf and those investigations did 

occur in 2007 and 2008. 

Chairman HARKIN. OK. As I understand it, the FDA contracted 

inspections to the Georgia Department of Agriculture in 2006, correct? 

Mr. SUNDLOF. I believe that is correct, yes. 

Chairman HARKIN. So what happened between 2001 and 2006, 

can I assume it just wasn’t inspected by anyone? 

Mr. SUNDLOF. I don’t think that is the case. The State of Georgia 

was in that plant frequently, at least twice a year every year. They 

were inspecting under their own authority and not under contract 

from the FDA. We formalized those contracts, I believe, with them 

in 2006. 

Chairman HARKIN. But the reports show that the Georgia Department of Agriculture found problems at the plant in 2006, 2007, 

and 2008. Did the FDA know at that time about this? Did they 

learn about this from the Georgia Department of Agriculture? 

Three times, 2006, 2007, and 2008, the Georgia Department of Agriculture found problems there. Was this reported to the FDA? 

Mr. SUNDLOF. The problems were reported to the FDA in 2007 

and 2008 under the inspections that were conducted under FDA 

contract. 

Chairman HARKIN. So again, if, in fact, the Department of Agriculture of Georgia found these problems, reported them to the 

FDA, did the FDA take any action at that point in time? 

Mr. SUNDLOF. The State of Georgia investigating or inspecting 

under our authority found infractions where they discussed these 

with the firm and the firm took corrective actions. So when the report goes back to the FDA from the State of Georgia, we make a 

determination of whether or not those violations were corrected, 

and if they were, then we would schedule them for a regular reinspection. 

Chairman HARKIN. Let me get this clear. When the Department 

of Agriculture of the State of Georgia found these problems, they 

reported them to the FDA. Did the FDA—is that a requirement 

under that contract? 

Mr. SUNDLOF. Under the contract, they are required to report. 

Chairman HARKIN. To report that. But then what communications took place between FDA and the Department of Agriculture 

of Georgia regarding those problems? 

Mr. SUNDLOF. Well, the Department of Agriculture—in fact, if I 

can ask Mike—— 

Chairman HARKIN. Did they actually—because I understand they 

found things like mold and they found roaches and they found different things like that. That is from what I read. I can’t say that. 

Mr. SUNDLOF. Those were things that we found, that the FDA 

found in its inspection last month. 

Chairman HARKIN. Oh. 

10 

Mr. SUNDLOF. There were some sanitary and maintenance issues 

that the State of Georgia uncovered, and maybe Mike Chappell can 

talk to that since he is in charge of that part of the FDA. 

Chairman HARKIN. Can you enlighten us, Mr. Chappell? After 

the Department of Agriculture of the State of Georgia reported this 

to the FDA, what happened? 

Mr. CHAPPELL. Thank you, Mr. Chairman. These reports based 

on State contract inspections are evaluated by a supervisor in the 

district that is responsible for that State. In reviewing that report, 

the supervisor felt that the State’s inspectional findings and then 

the firm’s corrections based on the State inspections were consistent with observations and corrections that FDA would have 

made. 

If there had been an issue there where the supervisor felt that 

these were significant unresolved issues, they would have entered 

a dialog with the State inspection group to talk about those. The 

inspection reports that they got under State contract, those issues 

during the review of that were considered to be somewhat resolved 

and the State was working with this company over several inspections to resolve ongoing issues. 

Chairman HARKIN. So if this committee requested to see those 

reports that came from the Department of Agriculture of Georgia 

to the FDA and FDA’s response to that, that would be on file, 

right? 

Mr. CHAPPELL. Yes, sir. 

Chairman HARKIN. We could take a look at those, right? 

Mr. CHAPPELL. They are on file with FDA, yes, sir. 

Chairman HARKIN. And I would like to request that you make 

those available to this committee. 

Mr. CHAPPELL. Yes, sir. 

Chairman HARKIN. I ask this because just yesterday, media reports showed that a Texas plant that also contracted with the Peanut Corporation of America may have gone uninspected for as 

many as 4 years by the Texas Department of Agriculture. Have you 

read that? Do you have any knowledge of that? 

Mr. SUNDLOF. Yes. Those food firms are required to be licensed 

by the State of Texas, OK. This does not involve FDA, but they are 

required to be licensed and apparently this firm was unlicensed in 

that State. It was known to the FDA. I think we had it in our registry. The FDA has a registry of all food firms, whether it is foreign 

or domestic, that came out of the 2002 Bioterrorism Act. They were 

in our data base and we knew of that company. 

Chairman HARKIN. Are you telling me that FDA knew that there 

was this plant in Texas that was not being inspected by the Texas 

Department of Agriculture? Is that a fact, that they were not inspected by the Department of Agriculture? 

Mr. SUNDLOF. My understanding is that they were not inspected 

by the Texas Department of Agriculture because they were unaware, based on their data base, that the firm was manufacturing. 

Chairman HARKIN. And shipping interstate? 

Mr. SUNDLOF. And shipping interstate. 

Chairman HARKIN. Should I be alarmed about that? I mean, how 

many more of these instances are there in the United States where 

you may have a plant that is manufacturing, shipping interstate, 

11 

and you don’t know about them and the State doesn’t know about 

them? Or you know about them, but you didn’t inspect them, and 

the State doesn’t even know they exist, should I be concerned that 

there are dozens of these in the United States? 

Mr. SUNDLOF. Each State deals with these issues a little bit differently. We maintain, again, an inventory of all the food firms and 

we try and get to those food firms based on a lot of different criteria—whether or not they are producing a high-risk product, 

whether or not they have a past inspection history that indicates 

that they are likely to be out of compliance—a number of different 

factors as to how we choose specific food firms to inspect. But it is 

based largely on our identification of them as being a high, medium, or low risk. 

Chairman HARKIN. I know I have gone over. I just have one more 

thing I want to tie down here. Regarding the salmonella testing at 

the Blakely plant, is it correct that there were on five occasions 

positive tests for salmonella at the Blakely plant in 2007? The 

months, I believe, were June and July. 

Mr. SUNDLOF. Over the history from 2007, we know that on 12 

different occasions, they had tested positive for salmonella. 

Chairman HARKIN. Twelve occasions? Five in 2007? 

Mr. SUNDLOF. I believe that is correct, yes, sir. 

Chairman HARKIN. Well, what happened then? 

Mr. SUNDLOF. Well, as far as we know, and again, this is still 

part of the ongoing investigation, they shipped product. They retested the product at some point and received a negative finding. 

So they originally had a positive finding for salmonella. They sent 

another sample to a laboratory, an independent laboratory for analysis, and they came back negative and they shipped the product. 

Chairman HARKIN. Right there, now they did not have to report 

to the FDA the findings of salmonella. 

Mr. SUNDLOF. That is correct. 

Chairman HARKIN. But you could go under the Bioterrorism Act 

and request later on, as you did, those reports, and that is how you 

found that out just recently, right? 

Mr. SUNDLOF. Right. We started to uncover some of that information before we actually invoked the bioterrorism provisions for 

records, but certainly that helped. 

And let me just say in regard to that, under the Bioterrorism 

Act, FDA cannot require records unless there is a reasonable belief 

that the product is adulterated and could result in serious adverse 

health effects. That is the criteria by which the FDA can require, 

demand records. So for the most part, in a routine inspection, those 

records may not be revealed to us because the company is not required to give us that information. 

Chairman HARKIN. Well, it seems to me that is one gaping loophole, that a company that does its own testing finds salmonella, 

does not even have to report that to the FDA. 

Mr. SUNDLOF. Yes, and let me just say—— 

Chairman HARKIN. To me, that is a big loophole. That one, at 

least, ought to be closed. 

Mr. SUNDLOF. There is some partial relief on that, and that is 

the Food and Drug Administration Amendments Act, I believe, of 

2007, in which there is now the requirement that FDA develop a 

12 

reportable food registry in which companies would be required to 

notify us in the event that they thought they had a problem. But 

in that particular case, the food would have had to have already 

been distributed. So the finding—if a company found salmonella in 

its product and did not ship product, it would not have to report 

to us. So there are still some additional loopholes, as you indicated. 

Chairman HARKIN. Thank you very much, Dr. Sundlof. 

Senator Chambliss? 

Senator CHAMBLISS. Thank you, Mr. Chairman. 

Dr. Sundlof, let me see if I can get a time line based upon your 

testimony and previous discussion with you. The first time that 

FDA became aware that PCA was manufacturing peanut butter at 

the Blakely facility was in 2001, is that correct? 

Mr. SUNDLOF. In 2001, PCA was not manufacturing peanut butter. They were listed as a peanut roaster and blancher. That was 

their operation at that time. 

Senator CHAMBLISS. All right. And the only reason FDA knew 

that there was any peanut processing going on at that Blakely facility was when some peanuts were attempted to be shipped into 

Canada and there were metal fragments found in those peanuts, is 

that correct? 

Mr. SUNDLOF. No. We knew that the plant was producing peanut 

butter in 2007 because the State of Georgia—— 

Senator CHAMBLISS. No, I am talking about 2001. 

Mr. SUNDLOF. Oh. 

Senator CHAMBLISS. In 2001 is when you discovered that there 

was any processing of peanut products going on at the Blakely facility, and the reason you discovered it then is because product was 

attempted to be shipped into Canada and there were metal fragments found in that processed product, isn’t that correct? 

Mr. SUNDLOF. I don’t believe that is correct. I think the metal 

fragments were found much later, in 2006, was it? 

Mr. CHAPPELL. Two-thousand-and-eight. 

Mr. SUNDLOF. It was 2008 that they shipped the peanuts to Canada and Canada rejected those because of metal fragments. 

Senator CHAMBLISS. All right. Well, let us go back then. Tell me 

when you found out that there were peanut products being processed at that Blakely facility. 

Mr. SUNDLOF. We knew in 2001 that they were roasting and 

blanching peanuts. That is what they reported to us. It was not 

until 2007, when the plant was inspected under FDA contract by 

the Department of Agriculture in Georgia, that we recognized that 

they were now—in addition to producing just the peanuts, they 

were producing peanut butter and peanut paste and peanut meal. 

Senator CHAMBLISS. And how did you become aware in 2001 that 

they were processing a peanut product there? 

Mr. SUNDLOF. They are registered in our data base of all food 

firms and they registered themselves as a roaster/blancher. 

Senator CHAMBLISS. OK. Do you know whether or not that is the 

point in time that they started producing products? 

Mr. SUNDLOF. We do not know that. 

Senator CHAMBLISS. OK. Then you had your first inspection, I 

believe you said 2006, 2007? What was that date? 

Mr. SUNDLOF. Mike, maybe you can help me out on the dates. 

13 

Mr. CHAPPELL. Yes. The first inspection of the Blakely facility 

was in 2001, and as Dr. Sundlof said, that was the time that they 

were blanching and roasting peanuts. They were not manufacturing peanut butter at that time. 

Senator CHAMBLISS. All right. And the Georgia Department of 

Agriculture conducted inspections from that point until what additional point in time before FDA went back into the plant? 

Mr. CHAPPELL. Actually, the State of Georgia conducted several 

inspections, as Dr. Sundlof mentioned, between 2001 and as late as 

2008. They do not keep their records, my understanding is, more 

than 3 years, so we know we have some instances where they inspected it four times in 2006. 

Senator CHAMBLISS. All right, but from an FDA perspective, 

when was the next time that FDA went into that plant, either 

under contract or on your own? 

Mr. CHAPPELL. The two inspections prior to the one in January 

were conducted by the State of Georgia under contract with FDA. 

Senator CHAMBLISS. And what is the date of that? 

Mr. CHAPPELL. Well, 2007 and 2008, as I recall. 

Senator CHAMBLISS. OK. 

Mr. CHAPPELL. I can get you the exact dates on that later if 

you—— 

Senator CHAMBLISS. All right. And when you ultimately discovered that the Blakely facility was the source of this outbreak, you 

immediately went to the plant to do what? What was your intention of going to the plant? 

Mr. SUNDLOF. Before we had absolute conclusive evidence but we 

were fairly certain that those products were involved, we went to 

the plant—I believe that was on the 9th of January—and we discussed the findings with the company. I would ask Mike to talk 

about that interaction with the company. 

Mr. CHAPPELL. The inspection was initiated because of information that we obtained—and I would like to back up a little bit and 

talk about how we got there. When it was obvious that King Nut 

was possibly implicated in this outbreak, we knew that King Nut 

corporate headquarters was in Ohio, and when we visited the Ohio 

facility, we learned that the King Nut brand peanut butter was actually manufactured exclusively in the Georgia plant, and it was 

based on that and the emerging data that suggested we need to be 

looking at peanut butter as a possible vector for this outbreak. 

That is when we initiated the inspection in the Blakely facility. 

Senator CHAMBLISS. And at the time you inspected the facility in 

January, did you have any authority to ask for all of the inspection 

records that the plant had done on its own? 

Mr. CHAPPELL. We routinely ask for records when we are following up these types of suspect links to foodborne illnesses. The 

firm was not required to provide us records based on our notice of 

inspection and initiating the inspection. 

Senator CHAMBLISS. Did they voluntarily give you those records? 

Mr. CHAPPELL. There were requests made for records, and during 

the course of the inspection, we did receive records on multiple occasions. 

14 

Senator CHAMBLISS. And is that when you discovered that there 

had been 12 tests done in that plant that showed positive for salmonella in 2007 and 2008? 

Mr. CHAPPELL. Actually, this is a series of events that occurred. 

When we originally started the inspection, we were focused on 

King Nut brand peanut butter, asked specifically for records relating to King Nut. As the investigation continued, and that included 

the epidemiological investigation and then reports coming in of 

samples of other products—an example would be crackers—that 

implicated other products, we asked for additional and other 

records. We did that on multiple occasions during the course of the 

inspection as this began to expand to other products other than 

King Nut peanut butter. 

Senator CHAMBLISS. Well, I am still not clear about your answer 

to the question, though. When did you discover that there had been 

12 previous positive findings of salmonella? 

Mr. CHAPPELL. We discovered that as we got these records over 

time. So by the end of the inspection, we had all 12 incidences. 

Senator CHAMBLISS. All right. What period of time did that cover 

then? 

Mr. CHAPPELL. The inspection started on January the 9th and 

ended on January the 27th. 

Senator CHAMBLISS. OK. So within that period of time, and you 

can’t tell us exactly when you found out that there were positive 

findings for salmonella, but somewhere during that period of time? 

Mr. CHAPPELL. It was on multiple days during that inspection. 

Senator CHAMBLISS. All right. Did anybody ever ask the company, have you ever found salmonella and can you give us the 

dates of when you found it and the test results showing positive results on salmonella? 

Mr. CHAPPELL. Early on in the inspection, we asked, had there 

ever been a positive salmonella finding for King Nut peanut butter 

and the firm provided us that information. As we moved forward 

and implicated other products and made other requests for other 

types of products they produced, the firm did provide some records. 

Senator CHAMBLISS. So when you asked that question to start 

with, they didn’t give you all their test results showing positive for 

salmonella? 

Mr. CHAPPELL. No, sir. 

Senator CHAMBLISS. Did the State of Georgia have this information relative to those tests? 

Mr. CHAPPELL. I couldn’t answer that, Senator. 

Senator CHAMBLISS. Well, I mean, you are under contract with 

them. Do you not know whether or not they had that, as your contractee? 

Mr. CHAPPELL. They did not provide that to us as part of the contracting inspections. 

Senator CHAMBLISS. But you don’t know whether or not they had 

that information? 

Mr. CHAPPELL. No, sir, I do not know that. 

Senator CHAMBLISS. Mr. Chairman, I am going to stop to let 

other folks ask questions and I will come back in the next round. 

Chairman HARKIN. We will do another round. 

15 

I will ask Senator Klobuchar both for an opening statement and 

for questions since a lot of this did focus in Minnesota. 

STATEMENT OF HON. AMY KLOBUCHAR, U.S. SENATOR FROM 

THE STATE OF MINNESOTA 

Senator KLOBUCHAR. OK. Well, thank you very much, Chairman 

Harkin, and thank you to our witnesses. 

This did focus on Minnesota in one tragic way and then in one 

positive way. The outbreak most affected my State in that three 

people have died, the most of any single State. One victim was 

Shirley Mae Almer of Perham, a small town on Northern Minnesota. At age 72, she was still a strong lady, but on December 21, 

she died and she died because every morning she liked to have 

toast with peanut butter. 

I believe it is shameful that a death like this could happen in 

America. All of this has obviously renewed public concerns about 

the safety of America’s food supply, as well as the Federal Government’s capacity to ensure the safety of the food that we consume. 

I am glad that the Department of Justice has opened a criminal investigation. 

On Monday, I sent a letter to President Obama urging him to 

nominate a new permanent FDA Commissioner as soon as possible 

to begin the process of reforming the Federal Government’s food 

safety system. A number of positive reforms have been discussed, 

including greater coordination and streamlining of responsibilities 

among Federal agencies, more resources, added authority for mandatory recalls, which I believe touches on some of the things we 

have talked about this morning, more effective prevention of 

foodborne illnesses, and better coordination between State, local, 

and Federal, which also has come up already this morning. 

The other way that this crisis has touched our State is in a positive way in that it was the Minnesota Department of Health, not 

a Federal agency, that discovered the source of the current salmonella outbreak, and I want to commend our Minnesota food safety team for their work. They are on the front line in the fight 

against unsafe food. I believe their work should be looked at as a 

model. 

This is not the first time that the Minnesota Department of 

Health has found the needle in the haystack. Last summer, there 

was another serious salmonella outbreak that caused hundreds of 

Americans to get sick. Initially, the FDA thought it was tomatoes, 

but after six Minnesotans got sick from eating in a local restaurant, the Minnesota Department of Health was able to pinpoint 

jalapeno relish as the source. They contacted the CDC and helped 

track down the culprit. It was the jalapeno peppers imported from 

Mexico. 

I admire the hard work of our Health Department, but all of this 

happened because of a failure, the failure of our government to prevent unsafe food from entering the food chain. 

The question that I have of you, Dr. Sundlof, I listened with 

some interest and sort of shock that we now—it seems to me just 

based on the questions with Senator Harkin, that a company can 

repeatedly have a salmonella problem in their plant and the FDA 

never knows about it, is that correct? 

16 

Mr. SUNDLOF. Thank you, Senator. Yes, that is correct. Again, 

the law that has recently passed, the Food and Drug Administration Amendments Act, does give us some additional authority to require that information if they have already shipped the product 

from their facility. 

Senator KLOBUCHAR. So you have to have this shipping, which 

obviously creates a much more hazardous possibility, before you 

can even find out. Do you think this is something the FDA should 

know about, when you have repeated outbreaks of salmonella at a 

plant? 

Mr. SUNDLOF. We would like to have as much information as we 

possibly can get, yes. 

Senator KLOBUCHAR. But right now, you don’t have that information. And if the States have it, if the States find out about it—he 

was talking about Texas and these things—then you automatically 

get it? 

Mr. SUNDLOF. If they report it to us. The States do a lot of inspections on their own. We don’t necessarily have access to 

that—— 

Senator KLOBUCHAR. So they are not automatically required to 

give you the information? 

Mr. SUNDLOF. They are not. 

Senator KLOBUCHAR. So we have a situation where plants can 

have repeated salmonella outbreaks, or salmonella discoveries. 

They are not required to tell you. And then you can have State departments of food and drug inspection that find this out and they 

are not required to tell you, is that correct? 

Mr. SUNDLOF. I think that is correct. 

Senator KLOBUCHAR. Yet we have seen from these deaths across 

the country that this isn’t a single State issue. To me, it seems like 

it is a national issue. 

Mr. SUNDLOF. That is correct. 

Senator KLOBUCHAR. All right. In April 2008, a Canadian distributor refused a shipment of peanuts from the Peanut Corporation because the peanuts had metal fragments in them. Are you 

aware of that? 

Mr. SUNDLOF. Yes. 

Senator KLOBUCHAR. And the products were then returned to the 

U.S. and destroyed after the FDA found the peanuts to be unacceptable. Now, I don’t know about you. If I found out my 13–yearold daughter, who, by the way, loves peanuts, loves peanut butter, 

if she was eating metal in her peanuts, I would expect the government to do something about this. So what happened? Was there 

any further action taken? 

Mr. SUNDLOF. We required the company to destroy that lot of 

product. 

Senator KLOBUCHAR. But you didn’t have the company—is there 

some allowance in the tools that you have now to then have the 

company on some special watch list where you are looking at repeat offenses and are concerned that there may be a problem here? 

Mr. SUNDLOF. Again, the plant was inspected on numerous occasions, several times by the State of Georgia, and again, some of 

those were under our contract. So Georgia was very vigilant in 

17 

making sure that they were going to that plant on a very frequent 

basis. 

Senator KLOBUCHAR. So Georgia went, but you guys didn’t really 

know they were going? 

Mr. CHAPPELL. Senator, when this lot was attempted to be reentered into the United States and several attempts to recondition it 

failed, we did ask the State of Georgia, under contract with us, to 

cover that during their next inspection, and they did that and they 

evaluated the firm’s ability to monitor and control metal fragments. 

Senator KLOBUCHAR. OK. 

Mr. CHAPPELL. And they reported back to us that their assessment was that the firm had in place processes to ensure that they 

didn’t get metal fragments in their product. That is not a real common occurrence. It typically is the result of some kind of machinery 

malfunctioning. It is not typically something that goes on over a 

long term. 

Senator KLOBUCHAR. And back to the salmonella issue, how 

much do you think this is going on in food processing plants and 

in different plants across the country where salmonella is found? 

If we find out there were, what, 12—is that what it was, Dr. 

Sundlof, 12 instances of this—— 

Mr. SUNDLOF. Yes. 

Senator KLOBUCHAR [continuing]. At this plant, is this unique or 

is this happening all over America? 

Mr. SUNDLOF. Well, this practice has been universally condemned and the industry certainly understands that this is not an 

appropriate way of ensuring quality of your product. Since the incident back in 2007 with Peter Pan peanut butter in the ConAgra 

plant, there has been a great amount of effort both on the part of 

the peanut industry and the FDA to inspect these plants and make 

sure that they are not engaging in practices that would lead to the 

salmonella contamination. 

There have been seminars and symposiums. There have been articles written that specifically talk about the fallacy of trying to 

test products into what we call compliance. In other words, once 

you find a positive sample of salmonella, it is well known within 

the industry that that product needs to be destroyed at that point 

in time because continued sampling to obtain a different result is 

fraught with problems. We know this. 

So I don’t believe this is a problem that is rampant throughout 

the industry. I believe this is one individual company. 

Senator KLOBUCHAR. But do you acknowledge that there are 

problems with the information flow here to the Federal agencies? 

Mr. SUNDLOF. We would like to have more information, there is 

no question. I think you can say that about all the products we regulate. The more information that we have, the quicker we can take 

the proper actions to prevent illness. 

Senator KLOBUCHAR. Do you think there are problems in that we 

have these voluntary recalls? Do you think that is working for the 

people of this country? That will be my last question. I see you 

going like this, Senator Harkin. 

[Laughter.] 

Mr. SUNDLOF. Regarding voluntary recall, FDA has a number of 

tools. Right now, as you indicated, we do not have the authority to 

18 

demand recalls. We do have the bully pulpit and we use that all 

the time. I don’t think there has ever been a case to my knowledge 

where a company has refused to recall product when we have told 

them in very specific terms that we would be taking additional actions, and those additional actions can be things like seizure. We 

can seize the product. We can enjoin the company from doing further business—— 

Senator KLOBUCHAR. But if you don’t have the information, you 

are not going to do that, and that was the problem, I think, for Ms. 

Almer and her family, so all right. 

Mr. SUNDLOF. Thank you. 

Senator KLOBUCHAR. Thank you. 

Chairman HARKIN. Thank you very much, Senator Klobuchar. 

Senator Leahy? 

Senator LEAHY. You know, I listened to the question of cooperation and it sounds good. Obviously, there wasn’t a heck of a lot of 

cooperation here. One of the witnesses we are going to hear from 

later is Gabrielle Meunier of South Burlington. She lives there in 

Vermont. Her 7–year-old son, Christopher, became severely ill. He 

was actually hospitalized for nearly a week with salmonella. He got 

that from peanut crackers. 

Now, all this voluntary cooperation didn’t tell her anything to 

say, take that out of her pantry. She is a mother, like all mothers. 

If she had gotten any kind of a warning that this is a danger, none 

of that stuff would have been fed to her children. We don’t have 

young children in our household, but our home in Vermont and our 

home down here, we constantly have grandchildren coming in and 

my wife and I scour the lists of any kind of recalls from your Department or anywhere else all the time. 

We are going to have Caroline Smith DeWaal testify here today. 

She is a native Vermonter, a graduate of the University of 

Vermont. Her mother still lives there. Her father, the late Dr. 

Durwood Smith, was Chairman of the Pharmacology Department 

at the Medical School at the University of Vermont, a highly respected person. 

I mention all this because as I sit here and listen, we hear, well, 

we want cooperation. Maybe we will get cooperation. For one thing, 

in this particular case, at least based on the news reports I have 

heard, this was a company that should have shut everything down 

immediately—immediately. I think, Admiral Khan, you would 

agree with that. At the first sign of salmonella, you go back and 

clean everything out. 

Wearing another hat, as Chairman of the Senate Judiciary Committee, I have written asking for criminal prosecutions in this case. 

If a company thinks, well, I will wait for an inspection, maybe 

there will be an inspection, maybe there won’t—I know, Doctor, 

that your Department is shorthanded. There is no conceivable way 

you could inspect everywhere. But if they think, well, if we get 

caught, maybe something, maybe a recall, maybe we will get a fine, 

it is a cost of doing business. Well, in this case, the cost has been 

people who have lost their lives. It has certainly been an enormous 

cost to companies who may have totally safe products, but they 

have had to recall them and now their products are tainted, at 

least in the public’s view. 

19 

I would like to see some people go to jail. I don’t really care what 

kind of a fine is put on a company that ignored this because I don’t 

think that really bothers people. It is like the horrible things that 

have happened in the financial markets. You give them a fine. It 

is the cost of doing business. When somebody thinks they are going 

to go to jail if they don’t report something, report it adequately and 

clean it up, that is an entirely different thing. It is not corporate 

headquarters that is going to pay a fine. It is the person who discovered it who is thinking, I might spend the next few years as a 

guest of the State in a small cell with bars on the window eating 

food that I am not too sure of. Then you are going to get them. 

What kind of steps are going to be taken in the next few months 

to make sure these kind of things don’t happen again, or do we 

have to assume they will happen again in some other area? 

Mr. SUNDLOF. Well—— 

Senator LEAHY. And you understand, Doctor, this is not directed 

at you. I am just so frustrated. I am looking at these people in 

Vermont. They do everything they are supposed to do and still 

their child ends up 6 days in the hospital with the anguish of the 

parents wondering, is the child going to live? 

Mr. SUNDLOF. Thank you, Senator, and there is a criminal investigation currently ongoing in this case. We don’t know how that 

will turn out, but certainly it is a concern that we had. 

We had our first wake-up call in 2007 with peanut butter causing salmonellosis on a nationwide basis, and at that time, we took 

what we thought were prudent measures in, first of all, inspecting 

peanut plants, peanut butter plants around the country to make 

sure that they were practicing good, safe production processes. We 

held seminars. We discussed a lot of this with the peanut industry. 

We thought, and we still do think that they have made changes to 

their process and they have educated their members to make sure 

that this doesn’t happen. 

It was just as disappointing to us to find out that after all of this 

additional work that had gone on, that a single company could let 

this happen. After the recall is completed, we will be looking back 

and see about what went wrong, what could we do in the future 

to prevent this from ever happening again, I can assure you. 

Senator LEAHY. My time is up, Mr. Chairman. No, that is OK. 

I am hoping to get to the next panel before I have to leave. 

Chairman HARKIN. All right, good. 

Well, we do want to get to the next panel, but I do want to ask 

Admiral Khan from CDC a question. It seems to me that, well, as 

I said earlier, we want to get to the prevention. We want to stop 

this before it happens. But if something happens and there is an 

outbreak, the question has to do with coordination and discovering 

things more quickly. Now, this has been going on for 3 months— 

three months. It seems that PulseNet has helped to coordinate all 

this, but they need to be discovered more quickly. 

Besides the solution to add more money to the budget, what 

other authorities does CDC need to more quickly diagnose these 

outbreaks? As I understand it, PulseNet is triggered at a certain 

level of illnesses. I don’t know what that is. What threshold causes 

an activation of this system? Should it be lower than what it is 

right now? How can we get to these more quickly than 3 months? 

20 

Admiral KHAN. Thank you, Senator, for that question. I do want 

to make a comment. I am a pediatrician and Christopher’s story 

really resonates with me. With these diseases, unfortunately, it is 

the very young, the very elderly, and the immunocompromised who 

get infected, and again, there were eight tragic deaths associated 

with this illness. So prevention really is key, and that is a shared 

public health mission between CDC and FDA and industry. We all 

have the same mission. We want to really limit these illnesses, and 

if we can’t limit them, find them as early as possible. 

Now, the outbreak originally started in September, so it took two 

months of cases before PulseNet was triggered, a blinking light 

that we have some lab cases that are associated. And December 

was when sort of the alarm bells go off. There is too much of this, 

so an extensive, intensive investigation conducted in collaboration 

with FDA and our State and local partners. And 1 month of investigation that got us eventually to what we thought the agent was 

likely to be, and then the timely investigation by FDA that went 

into the plant to figure out what was going on. 

Now, this is actually quite typical for what happens with 

foodborne outbreaks. This time line that I have just laid out to you 

over a couple of months is very typical of what is going on with our 

outbreak responses currently. And as you just mentioned, there are 

a number of opportunities to really shorten this time line to where 

we have cases identified a lot quicker and we have a response a 

lot faster. 

And to make that happen, we need a couple of things. So the 

first thing is we need new tools at the local, State, and national 

level to investigate these outbreaks. So I mentioned originally how 

PulseNet had two separate patterns, that with new technology, we 

recognized it was one, the same outbreak. So we need new laboratory tools to make that happen. 

We need new information tools to do the investigation. We need 

tools such as computer-assisted telephone interviews to do these investigations. We need new ways to standardize, analyze, bring information together in real time, so right away, to understand what 

is going on. 

So there are a number of tools we need. We need new tools to 

look at new diseases, such as C. difficile and other diseases that 

we want to look at. So we need new tools. 

The second thing we need is better investment at the State and 

local level to actually make these diagnoses quickly, do the 

PulseNet testing very quickly, do the interviews very quickly, and 

then come to a determination that we think this is an implicated 

exposure and then hand that off to FDA as fast as possible so they 

can do their timely response. 

So more tools, new tools at multiple levels, and the investment 

in public health at the State and local level. I am a big fan of CDC. 

I work at CDC. CDC is vital. But the bottom line is public health 

occurs at the State and local, Tribal and Territorial levels. That is 

where thousands of public health professionals every day are making these diagnoses, investigating these outbreaks, and we need to 

support them. 

21 

Chairman HARKIN. Now, you just told me something I didn’t 

know. Obviously, this has been over a 5–month period of time now. 

You say it was started in September? 

Admiral KHAN. Yes, sir, September 1st, I believe, was the first 

onset case, sir. 

Chairman HARKIN. So a lot of people are getting sick and perhaps even dying as this thing goes on and on and on. So you are 

telling me in order to make this more efficient and quicker, we 

need new lab tools, more tools, more personnel? 

Admiral KHAN. Definitely. I met last week with the State and 

Territorial epidemiologists. These are your leaders at the State 

level, the public health leaders, and basically they want boots on 

the ground. They need people who can help look at—so we are just 

describing for you one PulseNet cluster. There are over 150 

PulseNet clusters. 

Any given large State health department, such as yours, would 

be investigating during the winter maybe 20 or 25 clusters at any 

given time. So they need the boots on the ground to analyze those 

specimens, not have to wait weeks potentially to test them. They 

need boots on the ground to say, this is a cluster. They need tools 

to look at those clusters. 

And they need boots on the ground to make all the calls and follow up with these people and say, what did you eat, in a timely 

manner instead of four or 5 weeks, months after the fact, say, what 

did you eat back in September? You would like to be as close to 

the illness as possible to ask those questions while the memory is 

fresh. 

Chairman HARKIN. Admiral, you are saying what I have been 

saying for a long time. We have been saying the same thing, and 

that is we have for far too long ignored our public health sector in 

this country. I think we have just assumed that, well, things are 

OK. We just don’t have to do anything. 

But the fact that our—and we really haven’t done anything about 

good manufacturing practices under FDA since 1986. Think about 

the changes that have taken place in our food manufacturing and 

distribution system in the last 20– some years. You have something 

manufactured at a plant someplace and within 24 hours, it could 

be in 40 different States. That wasn’t true 20–some years ago. It 

is true now. 

So we haven’t changed and updated our public health system to 

cope with this new distribution system that we have in the United 

States, both with the manufactured food but also with produce that 

comes into this country that is just distributed all over, which we 

found with the peppers last year and tomatoes that Senator Chambliss mentioned. 

So it just seems to me that we have an obligation, I think, to the 

American people to really look at the public health structure in this 

country, the new challenges that we face, and come up with the resources that we need to get the boots on the ground, as you say, 

the people that are out there to help protect the health and wellbeing of the public out there. 

That is one thing. I asked you if the threshold should be lower 

on what triggers a PulseNet. Do you have any response to that? 

When I talk about that, people say, well, if you do that, then that 

22 

might lead to too many false starts, false things, and that takes a 

lot of time and consumes a lot of energy and money, so I am not 

certain where that threshold should be. 

Admiral KHAN. Sir, there is not a specific threshold. There are 

a number of factors that drive these investigations. So there are 

over 60,000 patterns in PulseNet generated any given year, 60,000 

patterns, and so as you look at those patterns, what happens is 

they look at the pattern itself, how distributed the pattern is into 

multiple States, how severe the disease may be associated with 

that pattern, how unique the pattern is. If it has never been seen 

before, like this one, that says, OK, this is probably more likely to 

be interesting, and whether or not that pattern has previously been 

associated with some other product. 

So there are a number of factors that go into deciding that this 

is a cluster that we need to follow, and then as that cluster is followed, there are triggers based on the disease that say, OK, we 

now need an additional level of investigation that requires us to 

call into place OutbreakNet and work with all our—more closely 

with all our State and local epidemiologists to really start making 

the calls. 

Throughout that process, we work very closely with FDA, and 

this was actually a really good example, as a side topic, of that 

closeness occurring back at the end of November-beginning of December to make sure that we had a collaborative relationship. 

Chairman HARKIN. Well, I will stop with this and yield to Senator Chambliss here, but it just seems to me here you have got an 

FDA that doesn’t require reports to be made to it if there is an outbreak of salmonella, as this plant did not have to report these 

things. They don’t have really the authority to go in and do much, 

as I understand it, right now. Then you have the CDC that basically is understaffed, undermanned, and really tracking these outbreaks down in a timely manner. It seems the two of them together 

really does cry out for some kind of better coordination, stiffening 

our laws. 

I think one of the things, we have got to close that loophole on 

requirement of reporting of internal findings of pathogens. And 

then a better coordination between FDA and CDC with more support for the Centers for Disease Control and Prevention in terms 

of being able to track things down in a more timely manner. Five 

months, I just think that is way too long to bring a closure on this 

and find out what is causing all these illnesses. Surely we can do 

better than that. 

Admiral KHAN. Yes, sir. Surely we can do better than that. We 

actually have excellent coordination and collaboration with FDA, 

and in this specific investigation, FDA was involved in the investigation way early in the investigation. We shared people between 

the agencies extremely early in the investigation, and we really 

worked very well on communications, which was something that 

came up after the tomato outbreak, to improve our communication 

strategies. We have gone to novel communication strategies together, Twitter, our blogs, podcasts, coordinated communications 

strategy with FDA, and FDA set up an excellent searchable 

website where people could quickly go in and figure out what products had been recalled. 

23 

Actually, I should best turn it over to FDA to talk about some 

of their coordinated activities, also. 

Chairman HARKIN. Well, I have to yield to my Ranking Member 

here. We have to move along right now. I will close it with that. 

Senator Chambliss? 

Senator CHAMBLISS. Dr. Sundlof, does FDA have any jurisdiction 

or control over the private labs, such as the one or ones that would 

have done the testing at this PCA plant? 

Chairman HARKIN. Good question. 

Mr. SUNDLOF. I don’t believe that we have any direct authority 

to require them to provide the results that they have based on a 

private firm, for instance. We don’t have the authority to require 

information that they would consider to be proprietary to that firm 

that they were testing for. 

Senator CHAMBLISS. You don’t have the authority to ask them for 

the information, nor is there any requirement that a private lab 

that tests a facility that processes food to be shipped in interstate 

commerce that finds a positive test, there is no requirement that 

they report that to you? 

Mr. SUNDLOF. Let me correct one thing. We do have the authority to ask, and we do ask on almost every occasion. They are not 

required to provide us with that information. 

Senator CHAMBLISS. But that is what I am saying. They don’t 

have to give it to you, nor is there any requirement that if they 

find a bacterial infestation in a food product that is going into 

interstate commerce, they don’t have to tell you about that, do 

they? 

Mr. SUNDLOF. I believe that is correct. 

Senator CHAMBLISS. Which is, again, one of those very serious 

loopholes that we need to try to plug. 

Last to you, Dr. Sundlof, the recall of products such as found to 

be contaminated with salmonella in this instance, does that have 

to be voluntary or can you demand that those products be recalled? 

Mr. SUNDLOF. We cannot demand that they be recalled. We work 

with the companies and the company—the recall is the responsibility of the company. The FDA does the audit checks to make sure 

that products are actually coming off of the shelves. 

Senator CHAMBLISS. And in this particular instance, it seems like 

every day for about the last two or 3 weeks, we have been getting 

in the media reports that additional products are being added to 

the list. So again, there is no way FDA has any control over what 

products are recalled other than the company itself advising the 

people to whom it sold the product to make their own recall of their 

products, is that correct? 

Mr. SUNDLOF. That is correct, and it has to go all the way down 

the supply chain, too, so that Kellogg’s is recalling their peanut 

butter crackers. It is not just the PCA company. 

Senator CHAMBLISS. Admiral Khan, I, too, am bothered by the 

fact that the first indication of this came on your PulseNet the first 

of September and here it was actually January the 19th before 

anything positive was done. November 10, you said in the monitoring of the Pulse system there were 16 States that showed up on 

the PulseNet. Now, that is a third of America that has all of a sudden developed some sort of illness. I don’t know whether you knew 

24 

it was salmonella or not then, but obviously you knew there was 

something going on in a third of the States. I don’t understand why 

that didn’t trigger more of an alarm on the part of the CDC to try 

to figure out what the heck is going on. 

Admiral KHAN. Thank you very much, Senator, for that question. 

So the original illnesses occured in September and October and the 

first PulseNet indication that something was going on was in November. The initial PulseNet patterns didn’t come in until early 

November. So we recognized them very quickly. 

But I talk about this as akin to driving while looking through 

your rear-view mirror. It takes 3 weeks for us to understand what 

is going on; and then to understand the impact of any decision it 

takes another 3 weeks in the future to understand the impact of 

those decisions. So based on the way our systems work, there is 

that delay. 

Now, there were actually, as I said, 13 patterns in 12 States on 

November 10. We have 60,000 patterns, over 300 to 400 clusters 

that are being investigated every year. In the winter, 25 to 30 clusters at any given time. So based on a number of criteria, such as 

how rare the pattern is, what the agent is, the severity of the 

agent, how widespread that pattern is, whether or not it has previously been associated with a food item is how we begin that investigation. 

And so the early steps of the investigation were as you heard, sir. 

Then the moment we sort of say, this looks like a unique pattern, 

we then reach out for increased monitoring of laboratory patterns 

to say, please, if you have any Salmonella Typhimurium, please 

type them very quickly. Salmonella Typhimurium is not at the top 

of the list in a State for typing. It is more likely diseases that are 

more severe, such as E. coli and listeria that would be likely to be 

typed. So we try to enhance the States to start doing the laboratory 

testing, and many of these clusters just disappear. 

When the cluster doesn’t disappear and has started to gain momentum, and in this case we were actually able to add it to a second cluster, and when those two clusters came together, it became 

very clear that this was a nationwide multi-State outbreak, and 

that triggered the full press with all the State epidemiologists saying, what is going on? Let us start interviews. Let us do some hypothesis generating. And then it takes about a month to sort of figure out what is going on. 

Senator CHAMBLISS. Well, you all have got to figure out some 

way to speed up that process. I don’t understand, with technology 

being what it is today. It appears that there is that public health 

network out there. We knew that 16 States were involved. I see 

nothing to indicate that CDC was aggressive in notifying public 

health systems in all 50 States that, hey, be on the lookout for this. 

I see nothing to indicate that, as I think has been evidenced by 

what Dr. Sundlof says, that because we have no jurisdiction over 

these private labs, that there is any regulatory requirement that 

private labs notify CDC when salmonella is found. I see nothing in 

your testimony—I am going to be interested to hear from Ms. 

Meunier with respect to her contacts to CDC where she drew a 

blank, but she did find somebody at FDA that was able to look at 

the actual crackers that her child had eaten. 

25 

When you take all of this in concert together, there is a huge 

breakdown in the system here. I don’t know whether it is stovepipes at CDC and FDA and the Georgia Department of Agriculture 

or what is going on here, but there is a total lack of information 

sharing between all of our food safety organizations that we simply 

have got to fix. I am not blaming you guys because you are the 

messengers here. But it is pretty obvious that we have got to make 

some major changes and we can’t do it without significant input 

from you folks. 

So as we move through this and learn a lesson from this, we are 

going to need to get you all back up here to talk about how we develop this legislatively or how we instruct you to do so from a regulatory standpoint, because, I mean, this was found September 1. 

November 25, when this child ate those crackers, this should have 

been well known to everybody in the public health community and 

it should not have happened. 

Thank you, Mr. Chairman. 

Chairman HARKIN. Thank you. 

I see Senator Johanns has rejoined our committee here. I was 

trying to get on to the second panel because of time, but I want 

to be responsible and respect your presence here, Senator, I say 

Mr. Secretary, but Senator Johanns. 

Senator JOHANNS. Mr. Chairman, I would suggest we go to the 

next panel. I am learning the challenges of three committee hearings all at once, so let us go to the second panel and I will make 

sure and review the testimony and the questions. Thank you. 

Senator LEAHY. Mr. Chairman, I will waive my second round of 

questions because we have gone so far over time. 

Chairman HARKIN. Thank you very much. 

This panel is excused. If you could stay around just in case something comes up for questions in the second panel, I would appreciate it. 

So we will call our second panel, Ms. Gabrielle Meunier from 

South Burlington, Vermont; Ms. Caroline Smith DeWaal, Director 

of the Program on Food Safety for the Center for Science in the 

Public Interest; and Mr. William Hubbard, former Senior Associate 

Commissioner for Policy, Planning, and Legislation for the Food 

and Drug Administration. 

Senator LEAHY. Mr. Chairman, I mentioned something earlier 

about Gabrielle Meunier. She does come here from South Burlington, Vermont. She is the Controller for Pomerleau Real Estate 

in Burlington. In my family, we know the Pomerleau family really 

well. I should mention I married a Pomerleau, so that is why, I 

should point out the connection. 

But that is not why she is here. She is here because she lives 

in South Burlington with her husband, Darrell, and their children 

and it was 7–year-old Christopher who became so severely ill. I 

think Vermonters throughout the State prayed for Christopher’s 

health and have been so aware of what he went through after the 

salmonella poisoning from peanut crackers. He survived, thank 

goodness, so I am glad you are here. 

But no parent should have to go through this. I think the case 

proves the FDA has to be given effective inspection oversight and 

Congress should look at requiring specific inspection frequencies for 

26 

all food plants. We have to work from farm to fork to make sure 

that we improve the safety of food in our country. 

Of course, Ms. Smith DeWaal is well known in Vermont. She is 

a native Vermonter, as I mentioned before. Her late father, Dr. 

Durwood Smith, was so highly respected in the Pharmacology Department at the Medical School of the University of Vermont. I 

knew him when I was State’s Attorney, and I should quickly add 

not because he did anything wrong, but he was very helpful to us 

in a number of areas. Your mother, Sue Smith, still lives in 

Vermont, is that correct? 

Ms. DEWAAL. Yes. 

Senator LEAHY. Mr. Hubbard, I am afraid I can’t make a 

Vermont connection for you, but you are welcome in Vermont anytime. 

Thank you, Mr. Chairman. 

Chairman HARKIN. He probably spent a nice vacation there once 

sometime. 

All of you, welcome. Your testimonies will be made a part of the 

record in their entirety and I ask you to summarize them in five 

to 7 minutes, if you would be so kind. 

Ms. Meunier, welcome again and please proceed. 

STATEMENT OF GABRIELLE MEUNIER, MOTHER OF AFFECTED 

CHILD, SOUTH BURLINGTON, VERMONT 

Ms. MEUNIER. Thank you very much. Thank you, Senator Leahy, 

Chairman Harkin, and the rest of the committee, for this opportunity to appear before you today and share the story of my son, 

Christopher, and our experience with the salmonella poisoning and 

the peanut recall that followed. 

On November 25, 2008, my perfectly healthy and robust 7–yearold son, Christopher, started showing signs of what appeared to be 

the flu. After consulting with our pediatrician, we limited his food 

and made sure he got plenty of fluids. But just 2 days later, Christopher’s health deteriorated dramatically. He became violently ill 

and was in tremendous pain, a pain that no child should ever have 

to experience, and one as a mother I will never forget. How in the 

world could a seemingly perfectly healthy child get so sick in such 

a short amount of time? 

Once the lab results finally came back and he was diagnosed 

with salmonella, the picture became a little clearer. After six terrorizing days and sleepless nights in the hospital, filled with antibiotics, antifungus drugs, and no food or drink, his wrecked little 

body finally stabilized to a point where he could come home. 

Senators I could spend all day long telling you about our ordeal 

and Christopher’s terrible experience and the lingering questions 

that we still have about his long-term health, but I would rather 

use my time here today to help enact progress and change. 

Some excellent ideas have been proposed for improving our food 

safety system and I would like to add a few of my own. Senators, 

I believe that technology is the key to improving our responses to 

foodborne illnesses at every step along the way. 

First, there should be a national online foodborne illness data 

base registry that should be used as soon as a foodborne illness has 

been diagnosed. Such a tool should be utilized immediately when 

27 

the patient is in the hospital or the doctor’s office, for the patient 

to record the foods eaten over the last week. This way, the information is still fresh in the victim’s mind rather than over a week 

later, on the phone with a representative from the State health department for a two-and-a-half-hour interview. 

In this age of technology, I don’t understand why victims could 

not be given access to one another via a secure website and a chat 

room to allow them to talk to one another and possibly solve the 

question of which foods poisoned them. Had I had this opportunity 

to talk to other mothers whose children were sick and compare 

what they had eaten, I have no doubt we would have solved this 

cracker case back in early December. 

Those involved in the outbreak response should never underestimate how much the victims crave information. I was kept in the 

dark for way too long throughout this process. At one point, I had 

to insist on learning the specific kind of salmonella Christopher 

had because I was told I didn’t need to know. Victims must be kept 

in the loop with real-time information and there must be a way to 

reach all victims by phone. An automated phone message system 

for victims could easily be established for disseminating information. After all, how many people in this room got text messages 

from President Obama during inauguration weekend? We should 

have received some sort of alert as soon as there was the slightest 

possibility that crackers were suspected as being tainted instead of, 

by chance, in an online article I read. 

When I called the CDC, because I had remaining possibly poisonous crackers left in my home, no one would take my call. The 

FDA was willing to help, but the holiday and the inauguration 

came first and it delayed any action. In speaking with the FDA, it 

was made clear to me that the CDC was not sharing information 

about my child’s illness. All the agencies working on this outbreak 

should have had access to the same data. Technology must be used 

to share information between all the teams and lines of defense 

working on the outbreak. 

The public needs to be kept informed, perhaps via an alert system similar to those for storm warnings. This system could also be 

utilized to update the public when it is safe to eat a food. Right 

now, it is just a guessing game, a game of Russian roulette, and 

we all have to rely upon the media to keep us up to date, which 

is inefficient, at best. 

Next, I believe there should be a unified procedure for the genetic identification of food poisoning cases. Labs should be regionalized and best practices should be shared. Once identification is 

made and data entered into this registry, correlations can be made 

to determine if there is a pattern developing. Victims’ information 

will already be in the registry. They are important. So now, swift 

action can be taken immediately. 

After our experience, I believe there should be one team in 

charge at the national level. This team should use technology and 

the registry data base for collecting and disseminating their information to all lines of defense. It is crucial that our local doctors, 

the hospitals, the State health departments, the CDC, and the FDA 

all have access to this data base. As the system is now, Christopher’s doctors had to ask around on their own of other local pediVerDate Nov 24 2008 13:33 Mar 03, 2010 Jkt 000000 PO 00000 Frm 00031 Fmt 6633 Sfmt 6633 C:\DOCS\49576.TXT SAG2 PsN: SAG2
28 

atricians if patients had similar symptoms. Had there been a national data base that they could have referred to, they would have 

seen perhaps that there were clusters or similar symptoms in other 

States in the United States. This information is important for the 

first lines of defense to have. And were we to have a bioterrorist 

act in food, this data would be absolutely invaluable. 

Finally, I believe there needs to be personal responsibility in 

manufacturing and growing foods for consumption by the public. 

The owners of companies must be personally responsible for the 

safety of the foods they sell. Inspection records should be made online and made available to the general public, and owners should 

personally attest to the safety of their food. Manufacturers must 

take responsibility for all ingredients in their products and there 

should be a transparent process to verify that their suppliers are 

meeting certain standards. Clearly, this did not happen in this case 

and now the government must ensure this will never happen again. 

Thank you to the committee for holding this hearing today. I 

would like to close by thanking the staff at the Children’s Hospital 

of Vermont. Our family is so thankful that Christopher received 

the best care in the world, and lucky for us, he was a big boy to 

begin with. I shudder to think of the possible outcome had he been 

underweight or sickly to begin, and my heart goes out to all the 

other victims and the families who lost their loved ones. Thank 

you, and I welcome any of your questions. 

[The prepared statement of Ms. Meunier can be found on page 

85 in the appendix.] 

Chairman HARKIN. Thank you very much, Ms. Meunier. Right to 

the point and I appreciate it very much. 

Ms. MEUNIER. Thank you, Mr. Chairman. 

Chairman HARKIN. We will move to Ms. Caroline Smith DeWaal, 

who has been before our committee before in the past. We welcome 

you again, Caroline. Please proceed. 

STATEMENT OF CAROLINE SMITH DEWAAL, DIRECTOR, PROGRAM ON FOOD SAFETY, CENTER FOR SCIENCE IN THE PUBLIC INTEREST, WASHINGTON, DC 

Ms. DEWAAL. Thank you. Thank you very much, Senator Harkin. 

And to just clarify for Senator Leahy, my mother did relocate in 

Michigan a number of years ago to be close to her grandchildren, 

but I grew up there. I spent the first 20 years of my life there. 

Senator LEAHY. Remind your mother that there is a constitutional duty for grandparents to spoil their grandchildren. 

Ms. DEWAAL. I will. 

Senator LEAHY. Thank you. Tell her I said so. 

Ms. DEWAAL. Well, thank you so much, and really, it is as much 

for parents and grandparents, I think, that you are holding this 

hearing because it really does impact so many Americans when 

peanut butter becomes the source of one of these outbreaks. 

My name is Caroline Smith DeWaal and I have been Director of 

the Center for Food Safety at the Center for Science in the Public 

Interest for many years, working on food safety issues really since 

1991. In addition to CSPI, we are joined today on this testimony 

with Consumers Union, which endorsed the testimony earlier this 

morning. 

29 

The Peanut Corporation of America outbreak, like countless episodes in the previous 2 years, illustrates tremendous gaps, many 

that you have discussed this morning, in our food safety system. 

For example, the company had no food safety operating plan and 

ignored repeated positive salmonella findings. The State of Georgia 

lacked full access to the plant’s food safety records. The FDA failed 

to provide adequate oversight of the State inspection program and 

of the plant involved. Finally, the penalties available to FDA to 

prosecute this company don’t match the culpability of the company. 

Despite its size and scope, this event is neither rare nor unexpected. In fact, Congress, many committees, including yours, have 

held nearly 20 hearings in the last 2 years focused on failures in 

FDA’s food program linked to everything from spinach tainted with 

E. coli 0157:H7, pet food containing ingredients which were intentionally adulterated with melamine, and even a previous peanut 

butter salmonella outbreak. 

Now is the time for Congress to take action to fundamentally reform and fully fund our national food safety system. Legislation 

should focus on making the companies accountable for food safety 

while giving the State and Federal inspectors better tools to assess 

the food safety programs and the performance of companies. 

The heart of any reform effort lies in prevention, not response. 

Congress should require every food plant regulated by FDA to have 

a food safety plan detailing that it has analyzed its operations, 

identified potential hazards, and is taking steps to minimize or prevent contamination. Former Secretary Johanns knows that, in fact, 

that is the system we have for meat and poultry today, but it is 

not similarly applied to FDA-regulated products. 

Legislation should set specific inspection frequencies for all food 

plants and establish clear auditing parameters when States are 

conducting inspections on behalf of the Federal Government. Specific authority should allow inspectors to have access to the results 

of tests conducted by the plant as well as all food safety reports 

that support the written plan. Without this check, a company can 

follow the practices of this Georgia peanut company, which instead 

of fixing its salmonella problem, it fixed the tests. Congress needs 

to strengthen the State inspection and surveillance systems by providing assistance through training and grants. 

CSPI also believes that giving FDA authority to require better 

ingredient tracing and to order a recall are critical tools for responding to future outbreaks. Today, when you see notices of the 

recall, they often mention that it is voluntary, and that is true. But 

this type of language may not compel consumers to act with the 

requisite urgency because consumers might think, well, you know, 

if it were serious, FDA would have mandated the recall. 

These are a few of the elements already included in legislation 

before Congress that could have prevented the PCA outbreak and 

the massive recall which is still ongoing. President Barack Obama 

promised us a government that works. These new authorities and 

increased funding will certainly help FDA improve. But to deal 

with the root of the problem, Congress and the Obama administration will need to go beyond making a few quick fixes. Structural reforms are also essential. 

30 

Although FDA is responsible for the safety of approximately 80 

percent of the food supply, the FDA’s Commissioner must divide 

his or her attention among drugs, medical devices, foods, and cosmetics. And frankly, food issues frequently fall to the bottom of the 

pile. There is no single food safety expert in charge of the policies, 

the budget, and the enforcement staff, and no credible voice communicating to the public and the industry what can be done to prevent outbreaks. 

It is time to elevate food monitoring functions within the Department of Health and Human Services. With both the public and the 

regulated industries clamoring for change, there is no reason to 

delay. Preventing future outbreaks and recalls like the one you are 

investigating today is within our grasp. Thank you very much. 

[The prepared statement of Ms. DeWaal can be found on page 48 

in the appendix.] 

Chairman HARKIN. Thank you very much, Caroline. 

Now we will turn to Mr. William Hubbard, former Senior Associate Commissioner for Policy, Planning, and Legislation at the 

Food and Drug Administration. Mr. Hubbard? 

STATEMENT OF WILLIAM HUBBARD, FORMER SENIOR ASSOCIATE COMMISSIONER FOR POLICY, PLANNING, AND LEGISLATION, U.S. FOOD AND DRUG ADMINISTRATION, CHAPEL 

HILL, NORTH CAROLINA 

Mr. HUBBARD. Thank you, Mr. Chairman. I have a written statement, but I will just make a few extemporaneous remarks. 

I was at FDA for 27 years and the last 14 as an Associate Commissioner. I have dealt as frustratingly with this issue for many 

years, as you are expressing. I want to agree with your opening remarks, Mr. Chairman, about the fact that we don’t have an operating system, which I think is absolutely true. Despite all of the 

advances we have made in science and technology, we have not 

brought them to bear on this problem. We simply haven’t. In fact, 

FDA has a food safety system that is a relic of the 19th century. 

It is outmoded, outdated. It does not use modern scientific techniques. And it clearly needs a serious examination, in my view, by 

the Congress and the new administration. 

There are two particular areas I would like to focus on. One is 

FDA’s capacity to work under the current paradigm. The current 

paradigm was developed over a century ago and it would have inspectors randomly go into food facilities and look around and see 

if they find a problem. They might get in every few years, and they 

would attempt to correct the problem. 

That has clearly failed, but one of the reasons it has failed is 

that FDA’s food program has largely disappeared. When I came to 

FDA in the 1970’s, there were 70,000 food firms. FDA inspected 

35,000 times a year, so they got to everybody every couple of years, 

generally. Today, there are 150,000 registered firms with FDA and 

FDA does 7,000 food inspections. That basically means there is no 

‘‘there’’ there. 

Now, the FDA believes there are about 6,000 high-risk firms, so 

they do try to get into those with some frequency, and they should, 

firms, for instance, that make canned goods that could result in 

botulism. But they don’t get to the vast majority of the other firms. 

31 

And you can correlate, Mr. Chairman, that as FDA inspectors 

left those facilities, stopped going in the 1970’s and 1980’s and 

1990’s, recalls went up and adverse findings in the inspections they 

did do also went up. So you clearly had a correlation between the 

regulators going away and the problems going up. 

Now, I want to reiterate, I think most of our food supply is very 

safe. But we clearly have these kinds of problems that keep on happening. I just think we have to look at a new paradigm, and that 

new paradigm exists. The meat program at USDA has shown it. 

The juice and seafood programs of the FDA have shown that you 

can build a system of preventive controls, where a firm is asked to 

identify the hazards that can affect their food and then prevent 

them from ever happening. So you are not relying on FDA to catch 

someone after the proverbial horse has left the barn and then fix 

it. The firm would have a food protection plan, a food safety plan 

where they would identify hazards like salmonella, make sure it 

never gets in the food, and then you just simply won’t have these 

problems to the degree we have them. 

I will mention a few other things. FDA does need recall authority. As Dr. Sundlof said, they can often cajole a firm into a recall, 

but firms often stall. They like to talk to their lawyers. They like 

to think about it. They like to take a day or two. If FDA could 

order a recall, I think we could get things moving more quickly. 

And clearly, when you go into a firm, you need to get to those 

records very quickly. The bioterrorism act’s record access provision 

is seriously flawed. FDA can’t even, as Dr. Sundlof said, when they 

do a routine inspection, ask to see the records, even if the firm has 

the records, because you have got to have evidence that there is 

such a big problem, FDA has to pull that trigger on the Bioterrorism Act. So that clearly doesn’t work. 

I will end my remarks by answering Senator Leahy’s question. 

Yes, we are going to be here again, over and over again, unless we 

find a solution to this problem, because the outbreaks have tripled 

for FDA foods in the last 15 years, or almost tripled. That is a huge 

increase. So the problems are going up and FDA’s ability to deal 

with them is going down. So we need to give the agency some resources and some authority to fix this problem, in my opinion. 

Thank you for your time. 

[The prepared statement of Mr. Hubbard can be found on page 

59 in the appendix.] 

Chairman HARKIN. Thank you. Thank you very much, Mr. Hubbard. Very good testimony. Thank you. 

Senator Leahy, I know, has to get back to the floor and I am 

going to yield to him for opening questions. 

Senator LEAHY. Thank you, Mr. Chairman. 

Ms. Meunier, I have read your testimony. I have talked with you 

personally, as have my staff. I still think of this almost as a 

Kafkaesque thing you went through. You described a little bit in 

your testimony about the coordination interaction between the 

Vermont State Health Department and the CDC and the FDA—— 

Ms. MEUNIER. Yes. 

Senator LEAHY [continuing]. At the same time when you were 

trying to get information yourself as a concerned mother. Do you 

32 

want to tell me a little bit more about that? What went right? 

What went wrong? 

Ms. MEUNIER. Yes. Well, there was no one place I could go, and 

I have to say, I was not even aware that the FDA was involved. 

I thought this was between the CDC and my State health department. So I was never told that there was this FDA website that 

I could go to. 

Furthermore, it should be one website when there is a foodborne 

illness, not two, so I would just like to make that clear because people are totally confused as toward who is in charge. Is it my State? 

Is it the Federal Government? 

Senator LEAHY. Especially in an era where we are all used to 

going on the Internet—— 

Ms. MEUNIER. Yes. 

Senator LEAHY [continuing]. To find out everything from—— 

Ms. MEUNIER. Yes, we are. So when I actually talked to an FDA 

representative—and I do appreciate that, absolutely, that the FDA 

took my call where the CDC would not and refused to speak to 

me—I said, I didn’t even know you guys were tracking this information. I didn’t even know you were involved. But then when I 

found out that the FDA asked me all the same questions that the 

CDC asked me, I said to the representative, why don’t you already 

have this information? Are you not allowed to share the same data 

base? My interpretation of her response was that she did not have 

that information. 

The health department working with the CDC, we are talking 

about days’ and days’ delay. She has to track me down by the 

phone. You know, I am a busy mom. There were so many gaps 

which were common sense not smart practices, the time delays getting from the CDC to the State, from the State to me, all via 

phone. 

Senator LEAHY. If you ran your real estate business this way, it 

wouldn’t last very long. 

Ms. MEUNIER. No, because you have to grow with the times. 

They are using 20th century techniques in a 21st century society. 

Senator LEAHY. Thank you. 

Ms. MEUNIER. And also, can I just add that the statistical extrapolations that they used in this PulseNet I reviewed, and I can’t 

correlate that to what I went through because it seems to me that 

I could have determined the outbreak long before the statistical 

correlations did. 

Senator LEAHY. And it is one thing to just go through and recount everything you did, but also at the same time you had the 

very frightening experience of Christopher being in the hospital. 

Ms. MEUNIER. I did. It was an awful thing to go through. He was 

extremely ill, and for days, we had no idea. Neither did the hospital. Salmonella is not common where I live. I don’t know anybody 

who has ever been food poisoned. And so we thought that he had 

terrible internal injuries. We thought—never once did anyone mention, and I called the best doctors in Vermont, salmonella poisoning. And never once did we ever fathom that a cracker could 

contain poisoning, ever. It never dawned on anyone. 

Senator LEAHY. Especially the crackers that end up in kids’ 

lunch pails or—— 

33 

Ms. MEUNIER. Absolutely, and he happened to eat a special lot 

that day, but—— 

Senator LEAHY. Ms. Smith DeWaal, in your testimony, you mentioned that, and I think I am quoting you correctly, FDA’s infrequent inspections and the agency’s oversight of State contracted inspections contribute to illness outbreaks. Could you speak a little 

bit more about mandatory inspection frequencies? How often 

should they be done? 

Ms. DEWAAL. Thank you, Senator Leahy. This is a critical issue, 

I think, that will need to be resolved for any legislation to address 

problems at FDA. Let us look for a moment at the meat and poultry inspection system, which was passed in 1906 based on some 

scandals and problems that were happening at that time. They required a daily inspection at meat plants. For slaughter plants, they 

can’t even start operations until the USDA employees are in the 

plants, in their position, really. And for even processed meat products, they have inspection on a daily basis. 

Now restaurants are another food venue very important to consumers. Those are inspected by States. The best advice to the 

States and the one States try to follow is to inspect restaurants 

twice a year, at least twice a year, and if they are having problems, 

they should get in there more often. 

The FDA inspection—first of all, the FDA has no mandatory inspection frequency today for food plants. They do have a mandatory 

inspection frequency for drugs, drug plants, which means they are 

going to go to the top of the list when they get to the inspection 

system. So today, there is no requirement. The average inspection 

rate is about once every 10 years, and as we heard, so much of the 

job is now being done by the States with inadequate coordination 

with the Federal Government. 

So I think there is a lot of room for improvement in these systems and we would be happy to work with your staff on the exact 

elements that could help improve it. Thank you. 

Senator LEAHY. Thank you very much. Ms. Meunier, Ms. Smith 

DeWaal, Mr. Hubbard, thank you very much. I know all of you 

have concern in this area. I appreciate you taking the time. 

Mr. Chairman, thank you for holding this hearing. 

Chairman HARKIN. You are welcome. 

I now yield to Senator Chambliss. 

Senator CHAMBLISS. Thank you, Mr. Chairman. 

Ms. Meunier, first of all, we are glad your son is doing better. 

Ms. MEUNIER. Senator Chambliss, I would like to address that. 

In my experience, when you have such a bad infection—the salmonella causes an infection called C. diff, which is Clostridium 

difficile. He got those both at the same time. Is there a possibility 

C. diff was in the food? I ask this question to you and I ask it to 

the CDC. We do not know enough about the growing concern of C. 

diff, and it is an awful, awful, nasty infection. 

Christopher had both as a result of eating these crackers. He was 

extremely ill and it is going to take a long time for full recovery 

from this illness. I don’t know how other people deal with salmonella, but one of my beefs with keep saying that these salmonella patients have recovered is that is not the truth. Many people have lingering arthritis as a result. My son has arthritis now, 

34 

a 7–year-old. It comes and goes. I don’t know if he will fully recover 

from that ever. 

So food poisoning, while in some cases can be absolutely intermittent and somebody be totally healed within a week, but not in 

all cases and certainly not in the case of my son. 

Senator CHAMBLISS. Did you have occasion to go online to the 

CDC website at all during this process, and if so, at what point in 

time would you have gone on to check for salmonella? 

Ms. MEUNIER. I went into the CDC website later on in the process. I was not aware that there was a website. I was doing nationwide searches on my own, just data searches through the web to 

find out what was going on. So had I known there was a CDC 

website that I could get information from, I would have gone first 

and foremost to that website. 

Senator CHAMBLISS. OK. So you didn’t obviously find out anything about PulseNet early in the process. 

Ms. MEUNIER. I read about PulseNet, yes. I also read that I am 

not sure that every State—I don’t know how it interacts in every 

single State, all 50 States. 

Senator CHAMBLISS. OK. Ms. Smith DeWaal, Mr. Hubbard, I appreciate your comment about recall. We can get ourselves into a 

very difficult situation if we go too far, but yet to not give FDA 

some authority here more than what they have got, I am just not 

sure that is the right thing to do, either, and here is my dilemma. 

We talked a little bit about this tomato issue last year. FDA 

identified tomatoes as a source of salmonella last year and issued 

a warning to all of America, don’t eat tomatoes. And this went on 

for a period of weeks. A month after FDA issued that warning to 

the American consumer, they made a determination that it wasn’t 

tomatoes at all, that it was peppers that came out of Mexico. If 

FDA had the authority to recall product on its own, they would 

have done so immediately, I am sure, and they would have recalled 

all tomato products. 

During that month, the tomato industry in my county and in my 

part of the country was devastated, lost hundreds of millions of dollars that they haven’t received a dime from, and it was not the 

farmers’ fault. Obviously, it was a reaction on the part of FDA, 

right or wrong. In this case, it was wrong. They used the best information they had. 

So my question to you is, how do we really go about thinking 

from a recall standpoint how much authority we give the FDA and 

how much leeway should they have relative to this issue of recall? 

Mr. HUBBARD. Could I, Mr. Chambliss, defend FDA on that tomato point, if I may? The CDC determines what food they link 

with a foodborne outbreak, and so CDC instructed FDA that they 

had determined it was tomatoes through their epidemiological findings and their questionnaire process, which is not an exact science. 

About midway through the outbreak, as I understand it from 

FDA officials, the FDA field folks recognized that there was a disconnect between the growing patterns in Florida and Georgia and 

other States and the epidemiological findings, and so they went to 

CDC and asked if they could see the raw epidemiological data so 

that they could confirm that, in fact, it was tomatoes, because FDA 

did not believe it was tomatoes at that point. FDA was denied that 

35 

information, and so they continued to chase tomatoes fruitlessly for 

several more weeks. Finally, when they were allowed to turn to 

peppers, I think it took about 2 days to find the contaminated peppers on the Mexican border. 

So the system is clearly flawed in the sense that you don’t have 

the communication and cooperation between State health departments, the CDC, and the FDA to identify the right food quickly. 

Now, I am sure if CDC were here at this table, they would be explaining that circumstance very differently than I just have. But 

the point is there was not agreement that it was tomatoes. It 

turned out it wasn’t tomatoes, but a lot of effort went into it. 

But to your question on recall, I think if FDA could recall only 

so-called Class I products where you have a risk of serious illness 

or death, then I think even the food industry would agree that a 

recall in those conditions would be acceptable. A recall for, say, a 

labeling violation would be perhaps something that they would not 

agree with. 

Ms. DEWAAL. Thank you, Senator Chambliss. I think your question really illustrates the importance of prevention to really be our 

first line of defense. Any time one bad actor, whether they be in 

Mexico in that case or in the U.S., has a problem, it impacts the 

entire industry. I mean, I am sure in Georgia right now, they are 

very concerned about the impact of this one outbreak and this one 

bad actor on what is happening to sales of their products in the future. So the key is prevention. 

When you get to the point of responding to an outbreak, the public health officials have to take the most conservative approach to 

protect public health and FDA did use the best epidemiology that 

they had. There is a possibility that tomatoes were grown in that 

part of Mexico early in the season and then it changed over to peppers. I mean, that is a possibility I have discussed with officials at 

FDA. So it is possible that there was an early—that tomatoes may 

have been implicated early because there was actually a link. 

But the reality is these investigations are very complex. They are 

a lot like criminal investigations. They have got to go out and do 

gumshoe detective work. And the key to legislation that we are promoting in Congress is prevention. Let us get all of these plants, 

even to the farm level, let us get written food safety plans in place 

so they can be audited by the State, by the Federal Government, 

maybe even by the customer. But let us get these plans in place 

and let these records, the records that support the plans, be accessible to CDC, FDA, USDA when they need them for an outbreak. 

Thank you. 

Senator CHAMBLISS. Your point, Mr. Hubbard, about the fact 

that this is not an exact science, I mean, you are exactly right. In 

addition to that, you throw in the complications of the fact that 

those peppers came across from Mexico and we have got an inspection process, but obviously we are not doing a good enough job 

there or we would not have had that issue back at that point in 

time. 

I appreciate the testimony of all three of you. You have been 

very—— 

Ms. MEUNIER. Senator Chambliss, can I say one more thing? I 

am sorry for interrupting you. On PulseNet, anything I have read 

36 

and anything I heard, and I believe I just heard a doctor say something, there is a huge lag time before something gets to PulseNet 

and genetically typed, and then afterwards when you get the description of what the foods have been eaten that created the type 

that went into the PulseNet. And anything I have read speak up 

to a two-week lag time, and then you are asking people who have 

been poisoned what they ate 2 weeks ago. And what I have proposed will put a shortening to that time period. 

Senator CHAMBLISS. Well, the particular reason I asked you 

about that is that on November the 10th, there was this monitoring 

of clusters of salmonella outbreaks around the country that was on 

PulseNet. Sixteen States were involved. I don’t know whether 

Vermont was one of them or not. But if you had had access to 

PulseNet, or better yet, your doctor had had access to PulseNet and 

had gone in and looked at that, or if nothing else put your child’s 

information on there, just imagine what that could have done—— 

Ms. MEUNIER. Absolutely, and if we were able to have put into 

PulseNet what he had eaten, everyone would have that information 

instantaneously. 

Senator CHAMBLISS. Yes. Well, I think whether it is recall or 

whether it is after we discover an outbreak, that there is a huge 

disconnect and a lack of information sharing. Everything every one 

of you have said highlights that. We wrestle with this in the intelligence community and we are doing a better job. We have just got 

to do a better job in the food safety area. So thank you very much. 

Chairman HARKIN. Thank you very much, Senator. 

Senator Johanns? 

Senator JOHANNS. Just a couple of questions and maybe an observation. I will start with the observation. Having worked with 

FDA on some really complex food safety issues—melamine would 

be a good example—I have to tell you my impression was that they 

were doing as much as they could with the resources available. I 

really think it is important to focus on how much they can do and 

how far they can go with the resources at their disposal. 

You point out the resources have lessened. I certainly don’t debate that at all. That is something we have got to pay attention 

to on this committee. But that is the observation. 

The second thing is a question. I was reading the testimony, and 

this actually comes from the written testimony of Dr. Sundlof, but 

I must admit, it gave me a very, very deep concern. Here is what 

it says. ‘‘Peanut butter is sold by PCA in bulk containers ranging 

in size from five to 1,700 pounds. The peanut paste is sold in sizes 

ranging from 35–pound containers to tanker trucks. However, 

through its investigation, FDA has determined that PCA distributed potentially contaminated products to more than 300 consignee 

firms, many of whom then further distributed products, for consumption as peanut butter or for use as ingredients in hundreds 

of different products, such as cookies, crackers, cereal, candy and 

ice cream.’’. 

So my question today, what I would ask of you, Ms. Smith 

DeWaal, where do you feel we are at with the recall? What is your 

level of comfort with it? Give me a sense of that. 

Ms. DEWAAL. Well, thank you, Senator Johanns. We have been 

expressing concern since the recall was first announced about the 

37 

shelf life of these products. I brought in these recalled peanut butter crackers that came out of the pantry of our receptionist at CSPI 

who is over 60 and was very happy to give them to me. Luckily, 

she had not eaten them. These products can be in people’s kitchens, on their shelves for a long period of time. 

We are urging—earlier this week at CSPI, we asked—we are 

sending an open letter to retailers that have customer loyalty programs to actually send out alerts to people who purchased these 

products because it is really important that we get them out of people’s kitchens, get them out of their pantries. 

Peanut butter isn’t like spinach or ground beef or many other 

products which have a natural shelf life. These things seem to last 

forever. I mean, they probably don’t and there is probably a technical shelf life answer, but the reality is for a lot of consumers you 

buy a jar of peanut butter and you use it for however long until 

it is empty. So it is critically important that the actions continue. 

I mean, a lot of the media alerts, and FDA, I think, and CDC 

have been trying to do a good job at doing regular media updates 

and telling the media they are relying on them to get the information out, and I have seen a lot of responsible media. But we have 

to overcome the fact that consumers don’t—consumers think food 

is safe and they will see a package like that and say, oh, this 

couldn’t hurt me. 

So we really have to get it off the shelves. We have to get it out 

of vending machines. I have more concern in some ways because 

this outbreak has already killed eight people, caused huge numbers 

of illnesses, and it could go on. I have got the epidemiologic curve 

here which many of you have been referring to during your questions, but this could go on for a long time unless we can get—really 

actively get these products out of—off the retail shelves, but also 

out of people’s homes. 

Senator JOHANNS. There are so many things in this hearing—I 

am running out of time already—that we can focus on, but I have 

to tell you, I see it as kind of a triage situation. You are right, this 

has a long shelf life. We have got product out there. I guess if there 

is anything I would ask of, whether it is your group, FDA, or whatever, is just to be kept appraised of what we think we are accomplishing in terms of getting dangerous product taken care of and 

consumers protected. 

Senator CHAMBLISS IS RIGHT. You are always trying to figure out 

the best course of action. These are complex issues. But your testimony indicates how dangerous this can be. A healthy, very young 

man and all of a sudden is in very, very serious trouble very, very 

quickly, and you are trying to figure out what the heck went 

wrong. You can only imagine how dangerous this is for an elderly 

person that enjoys peanut butter on their toast in the morning. It 

is deadly. 

Thank you. 

Chairman HARKIN. Thank you very much, Senator, and again, I 

thank all of you. This has been very good. 

Dr. Sundlof, I am going to have you come back up because I want 

to ask you some questions about what Ms. Meunier has said and 

to see if that tracks with some of the things we might want to do. 

38 

But I just, both for Caroline and also for you, Mr. Hubbard, I just 

wanted to—it seems in both of your testimonies, what I get out of 

that is that we simply have an outdated system here, that whatever worked 50 or 100 years ago just simply isn’t working now and 

it needs to be updated, both in terms of inspections, requirements 

for reporting, and in your case, Ms. DeWaal, in terms of fines. You 

pointed out when you have a $1,000 fine, that is not much of a deterrent at all. 

But what I would just like to cover with both of you, and you 

both kind of covered it in your testimonies, and that is right now, 

the current method as we have had in the past for FDA inspection 

involves an inspector showing up at the plant, which just basically 

is a snapshot in time as to what is really happening. Now we know 

from what we have done at FSIS with the HACCP system. Should 

we change that whole paradigm of how FDA operates? You kind of 

hit on that a little bit, Mr. Hubbard. I wonder if you could just follow up a little bit more on that. Do we need HACCP to go beyond 

seafood and—— 

Mr. HUBBARD. Juice. 

Chairman HARKIN [continuing]. Juice? Do we need it to go beyond that? 

Mr. HUBBARD. Absolutely. I think that is the No. 1 key. These 

other things, like recall authority, are very helpful. But if we could 

move toward universal HACCP across the food supply, I believe we 

would have an exponentially safer food supply, and you would have 

firms with the incentive to protect their food much more. FDA 

could then become more of an auditor and not so much of a punisher. 

I absolutely believe that, and I think the proof is in the pudding 

for meat and juice and seafood. We have seen outbreaks going 

down in those commodity areas. We are seeing better inspection results when the inspectors do go in. And the industry has accepted 

that as the way to go. In fact, HACCP was developed by the food 

industry. So in my view, that is clearly the way to go. 

Chairman HARKIN. Now, there are some other things you mentioned, also, and that was enforcement activities. Both of you mentioned that. Annual registration of all food facilities. Accreditation 

of private laboratories. You asked about the private labs and stuff 

out there. I mean, who are these people? Do we know, and do they 

report to FDA at all? I am asking that question. Do these private 

laboratories, when they do something, do they report to FDA? We 

know now that the plants don’t have to report to FDA. I earlier 

stated that as a big loophole. Maybe there is another loophole here 

if all these private labs out there don’t have to report, either. Is 

that the case? 

Ms. DEWAAL. That is correct. The labs are actually working for 

the plants, and so there are—unless the government is actually 

drawing the samples, and those samples would be done by government labs—the sampling that is done by companies, it is all voluntary and they hire the lab and in this case, they seem to send 

the—if they didn’t like the test results the first time, they send it 

back for retesting and ship the product when the retest was negative. So basically the companies—these are private contractual reVerDate Nov 24 2008 13:33 Mar 03, 2010 Jkt 000000 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 C:\DOCS\49576.TXT SAG2 PsN: SAG2
39 

lationships and the labs have no responsibility to report findings of 

potentially dangerous products to the government. 

In legislation that at least is being discussed on the Senate side, 

there would be a laboratory accreditation component that has certainly been discussed, and that is something that would certainly 

help. But we need to build all these records in. These testing 

records should become part of this mandatory HACCP system or a 

written food safety plan, however you want to frame it, to make 

sure that they capture the records that are part of the ongoing food 

safety monitoring in the plant itself. 

Chairman HARKIN. Let me ask one other question. It has been 

floating around for a long time. It gets introduced as a bill now and 

then—I think I may have even been on it periodically—and that 

was to set up a single food safety agency. Some people have said 

that the FDA, the Food and Drug Administration, really ought to 

be named the Drug Administration. They spend more of their time 

on drugs, certifying drugs, overseeing drugs in this country, but 

very little on food. Maybe we just need one single food safety agency. Do you have any thoughts on that, any of you? 

Ms. MEUNIER. I think it is a great idea, sir. 

Mr. HUBBARD. Ms. DeWaal will certainly endorse it. I actually 

spent a lot of time thinking about that in my time at FDA and 

there are clearly two points of view. The programs used to be together many years ago, and they diverged, and many argue that 

the drug emphasis in FDA is one of the reasons for the resource 

shortfall in the food area at FDA, that the commissioners and secretaries and Presidents over the years have made sure drug review 

got taken care of and it came out of the food side of FDA. And 

there is actually some empirical evidence to support that point of 

view. 

On the other hand, the FDA is a significant brand name in the 

United States and if you break it up and create this new thing, is 

it going to have the credibility and all that the FDA has? 

It is a tough call in many ways, and there is also the issue of 

if you do do it, would you spend all your time moving boxes as opposed to fixing the problem. 

Ms. DEWAAL. Let me give you the current thinking on this issue. 

Ms. Meunier and myself were actually at a bill introduction yesterday on the House side. The current thinking right now is that it 

wouldn’t make sense to create a single unitary agency until we 

modernize both sides of the house. 

Right now, the USDA law is significantly different from the one 

the FDA is operating under. So it really makes sense to modernize 

both FDA’s legal structure for food and eventually, though it is not 

really before you right now, the USDA model. And then after that, 

if it makes sense, you might create a single agency. But it is critically important, and the bill that was introduced by Chairman of 

House Agriculture Appropriations Rosa Delauro yesterday would 

take the food components, which you had two people testifying 

from FDA here today. That is because no one is really in charge 

of all of the components of food. You take all the components and 

put them under a new Commissioner of Food Safety or Nutrition 

who reports directly to the Secretary of Health and Human Services. 

40 

Chairman HARKIN. Well, why not just—since the food component 

at FDA, and I will ask Dr. Sundlof, maybe he doesn’t know, it is 

a smaller part of FDA than the whole drug regime is—why don’t 

you just move that over to the Food Safety Inspection Service? 

They have a history. They know how to do HACCP. We have been 

doing it for some years now. Why not do that? 

Ms. DEWAAL. Again, it would swallow—you have got two competing legal structures. So for USDA, they have got a lot of resources, but that is because they are required by law to inspect 

every meat plant every day, and that law is—I mean, I am not 

hearing that that law is going to change anytime soon. So simply 

taking the two existing laws and combining the agencies wouldn’t 

actually fix the problems and wouldn’t necessarily prevent the peanut butter outbreak. 

So what we have got to do is actually build the system at FDA, 

and you can either do that by keeping everything together at 

FDA—the brand name is important, and in the proposal the FDA 

brand will retain, will remain, but it will be the Federal Drug and 

Medical Device Agency. The FDA will regulate drugs and medical 

devices and there would be an FSA, the Food Safety Authority or 

Administration, that regulates on the food side. FSA is actually the 

name of an agency also in Britain that was formed after BSE really 

destroyed consumer confidence in their system. 

So you really have a proposal that is a very interesting one on 

the House side. On the Senate side, the legislation that we saw introduced last year, which was bipartisan, did not make that shift. 

It tries to fix things just within FDA. But I am concerned, Senator, 

that unless you address this structural problem where Dr. Sundlof 

is in charge of policy, but you have got someone over at the Office 

of Regulatory Affairs who actually manages who gets inspected in 

the food industry, the Commissioner’s office manages the budget, 

until you address the fact that food is really divided into all these 

different units, we are going to see these problems continue. 

Chairman HARKIN. Well, I don’t know. I am not certain I have 

a firm view on that myself, either. It just seems to me that there 

are just too many pieces out there and no one is really paying 

much attention to food safety in the beginning, aside from the recall problems and public knowledge right away of outbreaks and 

things that you pointed out, Ms. Meunier. 

Are you familiar with—the FDA has advanced the Food Protection Plan as a framework to improve food safety. The GAO has expressed concern that the plan does not contain enough specific information to assess whether it would improve FDA’s food safety 

program. Are you familiar with it, and what do you think, any of 

you? 

Mr. HUBBARD. Well, it is a broad sort of road map for improving 

food safety. I think it is fine. It is not—there is no money attached 

to it to do anything more. There are no specifics, as you say. There 

are no particular regulations that would be promulgated or new 

procedures. So it is fine as a very broad general goal, but it would 

need a great deal of implement to implement, in my opinion. 

Ms. DEWAAL. The one element that I would want to bring to 

your attention in the plan, because I think it is a fine plan, but it 

really focuses on what FDA considers high-risk facilities. I can tell 

41 

you, PCA was not considered a high-risk facility because peanut 

butter generally isn’t. So it is—and FDA also really doesn’t have 

the data that it would need. I mean, you know there has been controversy on this concept of risk-based inspection over at USDA. 

Well, they have a much more robust data set to support that than 

FDA has to support its decision about high-risk versus low-risk facilities. 

Chairman HARKIN. One last thing. If there had been a HACCP 

plan in effect at this plant, how confident are you that that would 

have prevented this salmonella contamination? 

Mr. HUBBARD. If there was a functioning HACCP plan, I think 

it would absolutely have because the firm would have identified 

salmonella as one of the likely risks to peanuts and peanut butter. 

The firm would have made sure the peanuts were roasted to a high 

enough level so that they were clean at the time they went into the 

processor to make the peanut butter. And their equipment would 

have been cleaned periodically. The skylights would not have 

leaked. The roof would not have leaked. The roaches would not be 

there. The rodents would not be there. And you would not have had 

the contamination. And therefore, in my opinion, a functioning 

HACCP plan would absolutely have prevented this problem. 

Ms. DEWAAL. It also would have given the State inspectors a lot 

more to go on during their inspection. They could have walked in. 

They could have seen the plan. They hopefully would have seen the 

test results. But they also could have looked at the plant itself and 

seen that it wasn’t actually living up to its HACCP plan. 

Chairman HARKIN. Thank you. Thank you all very, very much. 

I appreciate your coming here, your testimony, and you are right. 

C. diff is—I have been looking at this for some time now—— 

Ms. MEUNIER. It needs to be looked at further, I think. 

Chairman HARKIN. I will tell you, it is getting more and more 

around the country—— 

Ms. MEUNIER. Yes. There is something called community-acquired C. diff out there, and I read some analog yesterday that said 

it may possibly be in food now. So my concern is, was it in this 

cracker? I don’t know. We do not know how he got it. 

Chairman HARKIN. Thank you all very, very much. 

I would like to ask Dr. Sundlof if you could just come back to the 

table, please. I just want to follow up just on a couple of things 

with you here. 

Senator CHAMBLISS. Let us get Dr. Khan. 

Chairman HARKIN. Oh, yes, Dr. Khan, Admiral Khan from CDC. 

I just wanted to cover again, you heard the testimony of Ms. 

Meunier. I have been reading it over and I can just sense the frustration that she must have had at that time. You have this sick 

child, and trying to get information and trying to find avenues of 

accessibility. 

Now, she did say that when she found the FDA, she said, ‘‘thankfully, I found someone willing to listen. Unfortunately, it was the 

weekend and that Monday was a holiday, so no one could pick up 

the crackers until Tuesday. However, in a shocking twist, the 

woman I spoke with at FDA then also wanted to give me a questionnaire about all the foods Christopher had eaten, all the same 

information I had already given to CDC. I don’t understand why 

42 

the various agencies working on this outbreak did not already have 

this information and how they can share it.’’ 

And then it was all phone call. I wrote a note here, no e-mail? 

Is there any way that you can get e-mail out on this? It seems to 

me such a simple thing. How do you respond to that? Is this something we should be thinking about doing at FDA? 

Mr. SUNDLOF. We are always looking for better ways of communicating, and every time we go through one of these situations, we 

find more ways. So we are taking advantage of a lot of new technologies, things that I don’t even know what they are, but we are 

doing something called Twitter. We have bloginars. All of these are 

strange terms to me. But we feel it is extremely important to get 

the information out to people who need it. 

When we had the melamine situation, we were trying our best 

to reach out to the Asian community in the event that infant formula from China came into the United States. Since the salmonella 

St. Paul in peppers outbreak, we have held high-level meetings 

with CDC just to talk about how we can communicate better and 

how we can get our message out. 

In this particular outbreak, we were concerned about people who 

didn’t have access to the Internet, and that is especially prevalent 

in our senior citizens, who have not grown up with this technology, 

and how do we reach out to those people? CDC has an information 

hotline where they are actually encouraging people who don’t have 

Internet access to call their information hotline so that they can 

look up the list of recalled products. 

I certainly agree that communication in these situations where 

we need to get information out quickly to people is paramount in 

limiting the scope of the disease and we will continue to work toward that. 

Chairman HARKIN. Well, it just seems to me that Christopher’s 

doctors, they now have salmonella. They have asked for the—I 

don’t know if they did, but they could ask if there is any outbreak 

of a possible foodborne pathogen, what did you eat, and all they 

have got to do is enter that into a data base someplace. There 

should be software that would take that. All of a sudden, it flares 

up on your system. Oh, Christopher may have eaten five or six or 

seven things that day, and someone in Minnesota ate five or six or 

seven things and somebody else ate, but all of a sudden they all 

ate something dealing with peanut butter and that would flag it 

right away. It seems to me a software program like that is not very 

difficult to design. I ask both of you that. 

Mr. SUNDLOF. I don’t disagree. I would defer to Admiral Khan 

because these are the kinds of information that CDC handles. 

Chairman HARKIN. This is something that I would think CDC 

would have out there. 

Admiral KHAN. Thank you, Dr. Sundlof, and thank you, Mr. 

Chairman. A couple of comments. 

First, let me clarify dates. So even though there were cases in 

September and October, we didn’t hear about them until November 

in PulseNet, and that again goes back to these delays. 

Now, back to Ms. Meunier. I really want to thank her, what as 

an epidemiologist I call as a case or as a doctor, I call a patient 

43 

really as a person, an individual who got sick with a disease and 

tragically, it sounds like, has some complications from that disease. 

I also want to congratulate her and you on the comment about 

the solution. We really need to get better with this time line. How 

do we shorten these delays? And it is really about these new tools 

that allow us to do it, and there are numerous new tools, as I outlined before, communication, information tools that would allow us 

to do it. 

And finally, I am quite disturbed that she tried to contact somebody at the CDC and was not able to. We do have a system that 

allows people to do so. 

But the heart of this issue is communications, and we are doing 

a lot of innovative things with communications, such as you have 

said, blogs and Twitter and widgets that go onto websites, 

podcasts, and it is disturbing that people do not recognize that the 

CDC website is available for information. We have been careful 

about centralizing information. All the recall information is at one 

site, so you don’t need to go to 100 different sites. You are not getting different messages. You are getting a single consistent message every time. 

Chairman HARKIN. OK. Is there—is this site someplace where a 

local pediatrician or doctor could go in there right away and input 

some information right away and it goes into a system that is collated with all the other information that is coming in? Is there 

such a site? 

Admiral KHAN. No, sir, and that goes back to the tools we need. 

Those would be tools at the State and local level that currently do 

not exist so that if there is an individual who has an unfortunate 

diagnosis of one of these illnesses, right away, while their memory 

is fresh, you can get a full history questionnaire completed on 

them, and then as you log many of those together, you can look for 

the association then amongst the people who are ill and connect 

that to your laboratory patterns in PulseNet and go, voila, this is 

what the connection between those two are. So these are new tools 

that are needed at the local, State, and national level. 

Chairman HARKIN. Well, I am going to be interested in following 

up on that with CDC. Would you be in charge of that at CDC? 

Would that be under your jurisdiction? 

Admiral KHAN. Sir—— 

Chairman HARKIN. I want to know who is responsible. Who can 

I continue to talk with about this? 

Admiral KHAN. You can continue to contact us in the National 

Center for Zoonotic, Vector-borne, and Enteric Diseases. 

Chairman HARKIN. Well, because I am. I am going to write a formal letter to you at CDC outlining this and asking how you would 

structure such a system and when it could be implemented, how 

much would it cost, do you have the wherewithal to do it. 

Admiral KHAN. We would be glad to respond to that request, 

Senator. 

Chairman HARKIN. That really gets to the heart of what Ms. 

Meunier was talking about, is getting information in immediately, 

making sure it is correlated with all other information from other 

parts of the country, to flag these as soon as possible. And then 

44 

they could go on that site and see, well, are there other people having the same diagnosis, for example, 

That is really what I wanted to cover with them. I don’t know 

if you want to go into anything. 

Senator CHAMBLISS. I just have one quick question. Admiral 

Khan, do you know whether or not on November 10, when 

PulseNet revealed this cluster of outbreaks within those 16 States, 

whether or not Vermont was one of those 16 States? 

Admiral KHAN. Sir, I do not have that in front of me, but I will 

be glad to get back to you. 

Senator CHAMBLISS. If you could explore that information. And 

just to further one of Senator Harkin’s points there, it ought to be 

pretty easy to have some sort of software system there to where a 

physician in any emergency room that is treating a patient for a 

potential salmonella poisoning or infection could go to a CDC or an 

FDA, there ought to be some centralized website, but could pull up 

other cases that might be taking place around the country, and 

most importantly, to input information that they pick up in that 

emergency room from that patient. 

This is one of the things that it ought not take legislation to do. 

There is no reason CDC and FDA, and you may need to involve 

some other agencies, I don’t know off the top of my head who, but 

maybe the VA or somebody that is within the government that is 

a health care system, but there just ought to be some sort of central data bank for information like this. It just looks like it would 

go a long ways toward preventing a nationwide outbreak that extended from 13 States to 43 States. 

Thank you. 

Chairman HARKIN. Well, thank you very much, Senator Chambliss. 

Thank you all very much for being here. Again, I hope we don’t 

fall into what Mr. Hubbard said, we just continue to have these 

hearings and have these hearings and not much seems to happen. 

Something has got to happen here. I am encouraged by what President Obama said on Monday. He promised, quote, ‘‘a complete review of FDA operations.’’ Quote, ‘‘I think that the FDA has not 

been able to catch some of these things as quickly as I expect them 

to catch,’’ Mr. Obama said in an interview on the ‘‘Today’’ show. 

So hopefully, with the executive branch and with Congress, we 

can make some changes that will both, again, prevent—that is why 

the HACCP thing. We have got to think about prevention first. 

Even with that, once in a while things are going to happen and 

then we need the quickest possible information to parents and to 

our medical community out there to get that information out and 

then to get it to FDA as soon as possible so that recalls can happen. 

But I also think there are some of these other loopholes, in terms 

of accreditation of these private labs that are doing it, a requirement that they have to report to you if they find any foodborne 

pathogens, that they have to be required to report that to FDA 

along with any other State agency. If they have to report it to the 

State agency, they can send a copy to FDA. 

These are things, at a minimum, that we ought to be doing, I 

think. The broader picture, of course, is resources for the FDA and 

45 

what that is going to require. That is another thing we are going 

to have to wrestle with. 

But thank you all very much. This has been a very enlightening 

hearing. You have been great witnesses and we appreciate your 

being here and your testimony and we look forward to working 

with you in the future. Thank you very much. 

The committee will stand in recess. 

Admiral KHAN. Thank you, Senator. 

[Whereupon, at 12:37 p.m., the committee was adjourned.] 

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A P P E N D I X 

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