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THE SALMONELLA OUTBREAK: THE CONTINUED 

FAILURE TO PROTECT THE FOOD SUPPLY 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

FEBRUARY 11, 2009 

Serial No. 111–2 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

PARKER GRIFFITH, Alabama 

ROBERT E. LATTA, Ohio 

(II)

(III) 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan, Chairman 

BRUCE L. BRALEY, Iowa 

Vice Chairman 

EDWARD J. MARKEY, Massachusetts 

DIANA DEGETTE, Colorado 

MIKE DOYLE, Pennsylvania 

JAN SCHAKOWSKY, Illinois 

MIKE ROSS, Arkansas 

DONNA M. CHRISTENSEN, Virgin Islands 

PETER WELCH, Vermont 

GENE GREEN, Texas 

BETTY SUTTON, Ohio 

JOHN D. DINGELL, Michigan (ex officio) 

GREG WALDEN, Oregon 

Ranking Member 

ED WHITFIELD, Kentucky 

MIKE FERGUSON, New Jersey 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

(V) 

C O N T E N T S 

Page 

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

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

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

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

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

California, opening statement ............................................................................. 6 

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

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

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

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

Hon. Nathan Deal, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 9 

Hon. Bruce L. Braley, a Representative in Congress from the State of Iowa, 

opening statement ................................................................................................ 10 

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

Texas, opening statement .................................................................................... 11 

Hon. Donna M. Christensen, a Representative in Congress from the Virgin 

Islands, opening statement ................................................................................. 13 

Hon. George Radanovich, a Representative in Congress from the State of 

California, opening statement ............................................................................. 14 

Hon. Betty Sutton, a Representative in Congress from the State of Ohio, 

opening statement ................................................................................................ 14 

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

Tennessee, opening statement ............................................................................ 15 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 16 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 17 

Hon. Peter Welch, a Representative in Congress from the State of Vermont, 

opening statement ................................................................................................ 18 

Hon. John Sullivan, a Representative in Congress from the State of Oklahoma, opening statement .................................................................................... 19 

Hon. Edward J. Markey, a Representative in Congress from the Commonwealth of Massachusetts, opening statement .................................................... 19 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 20 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 95 

WITNESSES

Jeffrey Almer, Savage, Minnesota .......................................................................... 22 

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

Lou Tousignant, Minneapolis, Minnesota .............................................................. 28 

Prepared statement .......................................................................................... 30 

Peter K. Hurley, Wilsonville, Oregon ..................................................................... 32 

Prepared statement .......................................................................................... 34 

Stewart Parnell, President, Peanut Corporation of America ............................... 51 

Prepared statement 1 ........................................................................................ 51 

Sammy Lightsey, Plant Manager, Peanut Corporation of America .................... 51 

Prepared statement 2 ........................................................................................ 51 

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

Applied Nutrition, Food and Drug Administration, Accompanied by Michael 

Chappell, Acting Associate Commissioner for Regulatory Affairs, Food and 

Drug Administration ............................................................................................ 54 

Page

VI 

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

Applied Nutrition, Food and Drug Administration, Accompanied by Michael 

Chappell, Acting Associate Commissioner for Regulatory Affairs, Food and 

Drug Administration—Continued 

Prepared statement .......................................................................................... 57 

Oscar Garrison, Assistant Commissioner, Consumer Protection Division, 

Georgia Department Oof Agriculture ................................................................. 70 

Prepared statement .......................................................................................... 72 

Darlene Cowart, President, J. Leek Associates, Inc. ............................................ 78 

Prepared statement .......................................................................................... 80 

Charles T. Deibel, President, Deibel Laboratories ................................................ 88 

Prepared statement .......................................................................................... 90 

1 Mr. Parnell did not present an opening statement. 2 Mr. Lightsey did not present an opening statement. 

(1) 

THE SALMONELLA OUTBREAK: THE CONTINUED FAILURE TO PROTECT THE FOOD SUPPLY 

WEDNESDAY, FEBRUARY 11, 2009 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:05 a.m., in Room 

2123 of the Rayburn House Office Building, Hon. Bart Stupak 

(chairman) presiding. 

Members present: Representatives Stupak, Braley, Markey, 

DeGette, Schakowsky, Christensen, Welch, Green, Sutton, Barrow, 

Inslee, Pallone, Dingell, Waxman (ex officio), Walden, Deal, Radanovich, Sullivan, Burgess, Blackburn, Gingrey and Barton (ex officio). 

Also present: Representative Bishop. 

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

Mr. STUPAK. This meeting will come to order. 

First I want to take the opportunity to welcome all of our new 

and returning members to the subcommittee. I am honored to be 

able to serve as chairman for another term. I want to welcome our 

new ranking member, Mr. Walden of Oregon, and also Mr. Braley, 

the vice chair of this subcommittee. You have been on the subcommittee for some time, Mr. Walden. I look forward to working 

with you in a good, bipartisan working relationship in the 111th 

Congress like we had in the 110th Congress. 

I welcome Chairman Waxman in his new role as chairman of the 

full committee. Mr. Chairman, I know you will serve us well and 

will continue the tradition of aggressive and fair oversight that this 

committee has become known for. I also look forward to working 

with your staff along with Mr. Kevin Barstow, who in this case 

here traveled once again to Georgia to look at the peanut plants 

in Georgia as he did in 2007. I think Kevin is going to be in every 

peanut plant in Georgia if this keeps up, so I want to thank Kevin 

and Scott Schloegel and the whole staff for all their hard work in 

preparation for today’s hearing. 

I want to thank Chairman emeritus, John Dingell, the gentleman 

from my home State of Michigan, for his long and distinguished career in the House and here in the Energy and Commerce Committee. I must note today in fact the first resolution on the floor 

2 

today, so members will be moving back and forth in and out of this 

committee to pay tribute to Mr. Dingell as being the longest-serving Member in the history of the U.S. House of representatives. He 

served more than 53 years and 2 months. As was noted in the ceremony honoring Chairman Dingell last night, we will honor him for 

the time he has served and we honor him more for what he has 

done while serving. It is truly a pleasure and a privilege to serve 

with Mr. Dingell and have him on this committee. 

Now the business before us today. This hearing today that we 

have is ‘‘The Salmonella Outbreak: the Continued Failure to Protect the Food Supply.’’ We will begin with opening statements. The 

chairman, the ranking member, the chairman emeritus will be recognized for 5 minutes for an opening statement, and other members will be recognized for 3 minutes for their opening statements. 

I should note, there is a lot of interest in this hearing. We already 

have a statement submitted by the record with unanimous consent. 

Representative Sanford Bishop is here. He is from Georgia. He has 

an interest in this. And also Mr. Barrow is here, again not part of 

the subcommittee but he is a member of the full committee. Mr. 

Green is here, so a lot of interest in this hearing. So I will begin 

with the opening statement. 

Since late 2008, the United States has been in the grips of a nationwide outbreak of salmonella infections that to this date is believed to have caused 550 illnesses and eight deaths in 43 States. 

In January, public health officials in Minnesota and Connecticut 

connected the outbreak to peanut butter produced by the Peanut 

Corporation of America, PCA, at its plant in Blakely, Georgia. This 

finding triggered a series of recalls that have included all peanut 

butter and other peanut products produced at the facility for the 

past 2 years and recalls by over 54 companies of more than 1,900 

products containing the ingredients from the Blakely, Georgia, and 

Plainview, Texas, facilities of PCA. The recalls have cost business 

and government millions of dollars. The psychological cost has been 

widespread concern among parents of the millions of children nationwide who daily enjoy peanut butter sandwiches, cookies, crackers and other snacks. The President of the United States has expressed the view of parents across America when he said that his 

7-year-old daughter eats peanut butter probably three times a 

week and that, ‘‘I don’t want to have to worry about whether she 

is going to get sick as a consequence to having her lunch.’’ 

Today’s hearing will examine how this contamination was allowed to grow unchecked and the collective failure of multiple players—the peanut butter manufacturer, the Food and Drug Administration, State regulators and private industry—to take steps that 

might have prevented the outbreak. This subcommittee is well 

versed on the issues we address today. In the last Congress we 

held eight hearings to examine the safety and security of the Nation’s food supply including one in April of 2007 in which we specifically examined a similar outbreak arising from salmonella contamination of peanut butter manufactured by ConAgra. 

Although we continue to learn new facts about the outbreak in 

the Georgia facility at which it all started, the facts we already 

know paint a very disturbing picture. When the FDA inspectors entered the plant in Georgia, they found a facility riddled with unVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
3 

sanitary and unsafe conditions according to the inspector’s preliminary report. Mold was observed growing on the ceiling and walls 

in the cooler used to store peanut butter products. A live roach and 

several dead roaches were observed in the washroom adjacent to 

the production/packaging area. Most importantly, salmonella was 

found in two separate locations in the plant including the one that 

was only 3 feet from finished peanut butter products. Even more 

disturbing is the fact that Peanut Corporation of America knew 

about salmonella contamination for over a year and a half but did 

nothing to address it. Internal company records reveal that since 

June 2007, PCA’s products tested positive for salmonella on 12 different occasions but that the company continued to produce and 

distribute its peanut butter products without consequence. 

And we know that the multiple players had opportunities to report or detect the contamination but failed to do so. The FDA had 

the authority to conduct inspections at the PCA facility and to test 

for salmonella, but when the FDA sent state inspectors to the plant 

on its behalf in 2007 and 2008, it did not test for salmonella, even 

though both visits occurred after the 2007 salmonella outbreak 

traced to the ConAgra plant just 70 miles down the road from the 

PCA plant. One of these inspectors occurred just one day after 

PCA-manufactured product had tested positive for the presence of 

salmonella. The Georgia Department of Agriculture conducted two 

inspections of the Blakely plant in 2008 but did not conduct tests 

for salmonella on either occasion despite an internal goal to conduct such tests once a year. Private laboratories that conducted the 

tests when PCA had firsthand knowledge of the positive findings 

of salmonella failed to report those results to anyone but the company. Neither the FDA nor the State of Georgia requested access 

to those records until after the salmonella outbreak. PCA’s largest 

customers such as Kellogg’s engaged contractors to conduct audit 

of the Blakely plant but they did not conduct their own salmonella 

test and did not require PCA to show them their internal test results, which would have revealed a consistent pattern of salmonella 

contamination. 

So we appear to have a total systemic breakdown with severe 

consequences for hundreds of victims for which we need explanation. That is why we have asked representatives from each of 

these players, the manufacturer, the FDA, the State regulator, the 

private laboratories as well as victims of this outbreak to testify 

today. At this hearing we will seek answers to the following questions. What has been the human impact of this outbreak? How 

could the company, regulators, laboratories and industry let the 

salmonella contamination remain hidden for over a year before the 

outbreak? What legislative or regulatory changes can be implemented to prevent such catastrophic failures in the future? On this 

last question, it bears noting that we already have a vehicle for 

change in this area, H.R. 759, the FDA Globalization Act of 2009, 

which I am sponsoring along with Congressmen Dingell and 

Pallone. 

I look forward to today’s testimony as an opportunity to gather 

additional information with which to shape this legislation to address the public health impact of this and similar outbreaks. If 

there any good that can come from this tragic outbreak, it could 

4 

come from long-overdue legislative change to protect the American 

people from dangers in the Nation’s food supply. 

Next I would turn to my ranking member, Mr. Walden, for his 

opening statement, please. 

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

Mr. WALDEN. Thank you very much, Mr. Stupak, and Mr. Chairman, I look forward to working with you in my new role as the 

ranking Republican on the Oversight and Investigation Subcommittee. We have worked together on issues before for many 

years to protect the safety of Americans in many different ways 

and to improve security and other things in agencies. So I look forward to our work together. 

Ladies and gentlemen, I remember our previous food safety investigations into E. coli in spinach, E. coli in meat, salmonella in 

peanut butter, salmonella in jalapenos, now salmonella in a variety 

of peanut-containing products. This container is full of products 

that less than a month ago people were consuming thinking it was 

fine to eat, and one of the things I am going to do today is ask Mr. 

Parnell from Peanut Corporation of America if he would like to 

open this and sample some of the products that he didn’t think 

were a problem in sending out to the rest of us to eat. Now, there 

are some recalled products in here and there are some that are 

probably oK now. Lives were lost and people were sickened because 

they took a chance and I believe knowingly shipping product that 

was contaminated. 

Yesterday we learned there is another plant in Texas that the 

FDA didn’t even know existed that apparently has never been inspected and now we learn there was salmonella in that plant as 

well. This is simply outrageous. 

The latest outbreak of salmonella has sickened 11 people in my 

home State of Oregon. It has touched the lives of teenagers in 

Baker County and toddlers all the way the other side of the State 

in Medford and in Wilsonville. Pets have now been added to the list 

of those falling ill from salmonella-tainted products. A dog in Oakland, Oregon, apparently is the first animal illness in the Nation 

linked to recalled products. 

Today we will hear from a witness from one of these affected 

families, Peter Hurley. Mr. Hurley, I welcome you and your wife 

and your three children today. Jacob is here. Three-year-old Jacob, 

do you want to stand up and give a wave there? You are going to 

hear about Jacob’s story. Jacob became sick in January. For about 

2 weeks Peter and his wife watched as poor Jacob got sicker and 

sicker and they consulted their pediatrician and sought counsel and 

advice and poor Jacob apparently couldn’t keep anything down. 

The pediatrician said well, what does Jacob like to eat because at 

least maybe we can get him to eat what he likes to eat and help 

him along. Austin peanut butter crackers is his favorite. So he continued to peanut butter crackers, and eventually as the news came 

forward that those crackers and other products like those in this 

container may well be containing salmonella, a State epidemiologist showed up at their house on a Saturday night, took the crackers, and from what I understand, every other package was contamiVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
5 

nated with salmonella. Can you imagine the tragedy as a parent 

of knowing that in effect you have been poisoning your 3-year-old 

child with the help of your pediatrician, none of whom knew this 

was the problem until the damage was done? 

Salmonella is a naturally occurring microorganism. It is usually 

transmitted to humans by eating contaminated foods. To reduce 

the risk of contamination, we require food-processing firms to follow the Food and Drug Administration’s current Good Manufacturing Practices that serve as the minimum sanitary processing requirements for producing safe food. Failure to comply with the 

Good Manufacturing Practices is a violation of law, and if noncompliance leads to the distribution of adulterated or contaminated 

foods, more severe penalties may be applicable. Good Manufacturing Practices also serve as the basis for food-firm inspections 

conducted by the FDA and by State government inspectors. 

Now, the Peanut Corporation of America, whose president and 

plant manager are invited witnesses today, has been identified as 

the sole source of this salmonella outbreak. Several of the company’s products were tainted with salmonella at the PCA plant in 

Blakely, Georgia, and shipped to more than 100 consignee firms 

that serve as suppliers to food producers large and small for use 

as an ingredient in hundreds of different products such as cookies, 

crackers, ice cream, cereal and candy. At least two Oregon companies I am aware of have had to recall their products because they 

included ingredients that were sourced back to PCA. The health 

implications are all too clear, as our witnesses will testify today. 

Additionally, there are economic consequences for the food producers that use those ingredients and had to conduct those recalls. 

As FDA has reported and as indicated in documents obtained by 

this committee, the Peanut Corporation of America routinely violated numerous Good Manufacturing Practices and knowingly 

shipped adulterated products to its customers. In an internal email chain between the plant manager, Sam Lightsey, and the 

president, Steward Parnell, the two men discussed microbial testing completed on finished product. The e-mails state the company 

was notified of a confirmed positive salmonella test on a sample 

conducted by an outside lab. That sample was tested again and a 

negative reading occurred. Then Peanut Corporation of America 

shipped contaminated product to another outside lab and received 

a negative result. In response to getting a negative result, the company president gave instructions to his plant manager to ship the 

salmonella-positive products, specifically telling them ‘‘turn them 

loose.’’ Another e-mail from Mr. Parnell, the president wants to discuss another positive test of salmonella and the time lapse in the 

shipment of product as a result. Mr. Parnell expresses his concern 

of losing huge amounts of dollar sign, dollar sign, dollar sign, dollar 

sign, dollar sign due to delays in shipment and costs of testing. It 

appears Mr. Parnell was more concerned about his company’s bottom line than the food safety of Americans. 

Expert witnesses will explain that a subsequent negative test result for salmonella on a sample never, never negates the initial 

finding of a confirmed positive. In response to a confirm positive, 

PCA should have immediately destroyed the entire lot of contaminated product, ceased production and attempted to uncover the root 

6 

cause of the contamination. All these steps are part of the FDA’s 

manufacturing requirements that firms are forced to follow, required to follow. 

FDA must enhance the GMPs for food and get stronger authority. Food firms should be required to give FDA access to records 

that show compliance, prove that kill step for pathogens actually 

works and confirm sanitation and protection against cross-contamination. To help prevent outbreaks in the future, FDA inspectors 

must have access to internal documents. We must assure the public 

the food on our grocery shelves is safe and what we put into our 

mouths and those of our children, elderly parents and even our 

pets is safe. While Congress moves on legislation, our food safety 

agencies and food manufacturing firms can take immediate action 

to improve the production of safe food, and I suggest that we demand those actions now, Mr. Chairman. Thank you. 

Mr. STUPAK. Thank you, Mr. Walden. I suggest you keep your 

contaminated products on your side of the aisle. That would be a 

new way to get back into the majority but we will pass on that. 

Mr. Waxman, opening statement, please, sir. 

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

Mr. WAXMAN. Thank you very much, Mr. Chairman. I am 

pleased to see you continuing your aggressive oversight on the 

issues of food safety and I am pleased also to see that you are 

working with our counterparts on the Republican side, especially 

Ranking Member Walden, to do this in a bipartisan basis. There 

is no partisanship when it comes to questions of food safety. We are 

shocked at what has been going on in this country on food issues, 

and what this committee needs to do is to find out the truth, hold 

people accountable and make sure it doesn’t happen again. 

For too long, people have been worried about this and they want 

to know what is happening, who is responsible. Well, we are going 

to hear in this first panel that those who most often pay the price 

are the young, the elderly and the infirmed because these tainted 

products distributed by the Peanut Corporation of America were 

sent to elementary schools, nursing homes, hospitals and even 

FEMA meal kits handed out in the wake of the Kentucky ice 

storms. We are going to hear today the results of our subcommittee’s investigation and we have obtained documents that I would 

ask unanimous consent be made part of the record. 

Mr. STUPAK. Without objection. 

[The information was unavailable at the time of printing.] 

Mr. WAXMAN. These documents obtained by our subcommittee 

are very disturbing because what they show is that this company 

cared more about its financial bottom line than it did about the 

safety of its customers. Last September, for example, PCA was notified by a private lab that its products had testified positive for 

salmonella. This wasn’t the first positive test the company received 

and it may not be the last. In response, the president of the company sent an e-mail. Stewart Parnell was complaining that the 

positive salmonella tests were costing them huge amounts of 

money, and I see on the screen that we are flashing up this e-mail. 

7 

‘‘There is going to be a huge lapse in time from the time we pick 

up peanuts until the time we can invoice.’’ Well, even after the 

FDA began investigating in January and forced the company to recall some products, PCA’s first concerns were financial. On January 

19, Mr. Parnell sent an e-mail pleading with the FDA officials to 

allow the company to keep doing business. He wrote that they ‘‘desperately at least need to turn the raw peanuts on our floor into 

money.’’ He assured the FDA that these peanuts would be cooked 

and further processed by their Texas facility. This Texas facility is 

the same one that was shut down yesterday after salmonella was 

found there too. 

The subcommittee also obtained documents that appear to show 

that Mr. Parnell was not forthcoming about his company’s past. 

Despite multiple records showing positive salmonella tests over 3 

years, he wrote an e-mail to his company’s employees on January 

12 asserting flatly that, ‘‘We have never found any salmonella at 

all,’’ and he blamed the news agencies. They are looking for news 

stories that are going to scare people about the cause of this food 

sickness outbreak. The subcommittee obtained a statement from an 

official at one of the private labs used by PCA to test for salmonella. The lab official reported that PCA’s plant manager in 

Georgia, Sam Lightsey, admitted to shipping products before receiving lab results. The official stated, ‘‘When I called Mr. Lightsey 

in early October 2008 to give him the serology reports that JLA obtained from the lab for the confirmed salmonella, he paused and 

said uh-oh or something to that effect and then told me he had released the product for shipping. When I asked him if he could get 

it back, he said it was on a truck heading to Utah.’’ This lab official 

also informed us that PCA stopped using its services because it received too many positive tests. The official stated, ‘‘I called Mr. 

Lightsey to follow up on the recent discussion regarding the confirmed positive and he confirmed that because of the high coliform 

results, they are going to send samples to a different lab.’’ 

Mr. Chairman, I want all these documents in the record. I want 

them to be made public. I hope that in this hearing, we are going 

to be able to find out more about the actions of these PCA officials. 

I look forward to hearing from the labs that conducted these tests 

as well as the State and federal officials in charge of overseeing 

this company, and I also want to extend my condolences to the victims and family member, the victims who are here today. We have 

got to find out the truth. We have got to hold people accountable 

and we have got to make sure that this doesn’t continue in the future. 

Thanks for your hard work and the aggressive oversight that I 

know you are committed to. I yield back the time. 

Mr. STUPAK. Thank you, Mr. Chairman. 

I next turn to Mr. Barton of Texas for an opening statement. 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. Thank you, Mr. Chairman. 

Today you are going to see Congress at its best and at its worst. 

This subcommittee hearing is Congress at its best. We have an 

issue that affects the public health and safety of American people. 

8 

We have a chairman and a subcommittee chairman who have 

quickly acted to bring it to the country’s attention, to bring witnesses forward both from the victims’ side and from the regulatory 

side and also give an opportunity for the affected party, the company in this case, to present their side of the story. That has been 

done on a bipartisan basis with full cooperation including yesterday 

a full committee meeting, business meeting, where we unanimously 

voted to subpoena to compel some of the witnesses that didn’t want 

to voluntarily testify to come before the Congress so that people 

would know. That is Congress at its best. Mr. Waxman and Mr. 

Stupak are to be commended for their leadership. 

I also want to commend Mr. Walden, the new ranking member 

on the Minority side, for the best opening statement I have heard 

in 22 years in an oversight hearing, and that goes back to John 

Dingell, Billy Tozan, Tom Bliley, Mr. Waxman and others who 

have always specialized in aggressive oversight. He put the case 

succinctly. He put the case in personal terms. He did it in a way 

that we can understand. So that is Congress at its best. 

Unfortunately, today we are also going to see Congress at its 

worst. We have the stimulus package that is in limbo somewhere 

in conference between the Senate and the House of Representatives, and the House conferees were appointed yesterday. This committee, who has got jurisdiction for approximately $100 billion of 

that stimulus, including all the healthcare issues, all the telecommunications issues, all the energy issues, all the environmental 

issue has one conferee, the chairman of the committee. Nobody on 

the Minority side. It is a very small conference but the Speaker has 

seen fit that the Minority doesn’t count. Our voice doesn’t count. 

Well, I have a prediction to make. By the end of the day or the end 

of the week, they are going to hear the voice of the Minority on this 

issue. We need to do something to help the economy for this country, we need to do it cooperatively on a bipartisan basis, but when 

you shut one side out, it makes it very difficult to work in a positive fashion. 

So on a positive note, this is an important hearing. We are totally supportive. Whatever the results of the hearing are, I am sure 

we will work together to implement those, but on the other issue, 

it is not democracy when only one side has a voice. 

With that, Mr. Chairman, I yield back. 

Mr. STUPAK. Thank you, Mr. Barton. 

By order of appearance, members will be recognized for 3 minutes for an opening statement. Next would be Mr. Green from 

Texas. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

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

holding the hearing today. Last year we had many hearings on food 

safety, but unfortunately, the committee was never able to pass a 

food safety bill. The recent salmonella outbreak is yet another example of how the FDA and State agencies are unable to protect the 

American food supply. The committee’s investigation has shown 

that Peanut Corporation of America was operating with blatant 

disregard for safety standards, which ultimately led to at least 

9 

eight deaths and sickened 600 individuals. Investigations by this 

committee found the Peanut Corporation of America shopped for 

labs that gave them negative salmonella results after originally 

testing positive, that they would not wait for the results and would 

ship the products out for consumption without ensuring they were 

safe for consumption. Peanut Corporation of America’s plants are 

also in deplorable condition, especially the plant in Georgia with 

cockroaches near the peanuts, water leakage, mold and unsanitary 

production line. 

On the 3rd we learned that the Peanut Corporation of America 

was operating an unlicensed and uninspected plant in Plainview, 

Texas. This plant was never inspected until the FDA began investigating the salmonella outbreak, at least never inspected by the 

FDA. Unfortunately, my home State of Texas is one of the states 

where the FDA relies on our State inspectors to oversee food safety. 

On Monday the Texas Department of State Health Services shut 

down the Plainview plant after it tested positive for possible salmonella. It is unbelievable that a food-processing plant can deliver 

possibly tainted products into our food supply without a license and 

without ever being inspected. One thing is clear: No plant should 

be able to operate in the manner in which the Peanut Corporation 

of America has operated. 

Congress, myself included, said for years that the FDA is underfunded, and that is still true, but throwing money at them will not 

solve the problem. We need to overhaul the way the FDA reviews 

and inspects our food-processing plants and food supply. This committee, Congress and the new Administration must do all we can 

to shut down those unlawful operators and find a new way to protect the American food supply. 

Again, I want to welcome our witnesses here, particularly the 

children. I have a 4-year-old granddaughter who loves peanut butter and crackers. In fact, as I sit here today, my son, they are having a new baby this morning in south Texas, a little boy, and all 

of them, all my grandchildren eat peanut butter and I have a jar 

here, and I didn’t bring it to check it for salmonella, but anyway, 

it is so important for the American people literally from our smallest citizens to our oldest. 

Thank you, Mr. Chairman. 

Mr. STUPAK. Thank you, Mr. Green. 

Mr. Deal for an opening statement, please, 3 minutes. 

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

Mr. DEAL. Thank you, Mr. Chairman. 

First of all, I would like to welcome the deputy commissioner of 

agriculture from the State of Georgia, Mr. Terry Coleman, who by 

the way is a former speaker of the Georgia House of Representatives as a Democrat, Mr. Chairman, and also Mr. Oscar Garrison, 

who is the assistant commissioner of agriculture of the Georgia Department of Agriculture, who is going to testify on one of our panels. 

Mr. Chairman, our Nation has always prided itself on having the 

safest food supply in the world. This confidence is founded on the 

hard work of those who grow, process, package and deliver our food 

10 

coupled with the oversight and inspections provided by the federal 

agencies such as FDA and USDA working with their comparable 

State regulatory authorities. Let no one misunderstand, however, 

we are all outraged by the alleged violations of law and common 

standards of safety which are the focus of this hearing, and our 

sympathy goes out to those who were injured and to those who 

have suffered losses. Although I am a resident of the State of Georgia where the production of peanuts is a vital part of our State’s 

economy, there will be no statements of provincial protectionism 

from me for it is those who are closest to the problem that are the 

most infuriated by it for we know that the vast majority of those 

who produce peanuts and the resulting products are decent, lawabiding people. Right now peanut farmers are poised to plant this 

year’s crop. The uncertainty created by the actions of Peanut Corporation of America will cost them millions of dollars. They and 

many more in the chain of production have done nothing wrong but 

they are suffering the consequences of the questionable actions of 

one company. These innocent individuals and companies are more 

concerned than almost anyone that the cloud of suspicion be removed from the peanut industry. 

As legislators, we should be asking how we can make the system 

work better. I am sure we can learn from this unfortunate experience how to reform our inspections system at both the federal and 

state levels. In fact, the Georgia General Assembly is in session 

right now and is considering legislation to strengthen the role of 

our State inspections and oversight. We have the responsibility to 

shake the scales of justice as it relates to food safety but the architect whose eyes are focused only on the actions of the most egregious will design scales of justice that will not work for it fails to 

account for the overwhelming weight of the majority who are honest and law abiding. That is our challenge as we go forward to ensure the safety of all without destroying the underlying industry. 

I am confident that the peanut industry of my State and the Nation will work cooperatively with this committee, with this Congress and the legislatures of the various States to craft reforms 

that will restore the confidence of the American people in the safety of peanut products. Toward that end, I pledge my best efforts, 

for after all, the good health of the American public and in fact the 

fate of the peanut butter and jelly sandwich lie in the balance. 

Thank you, Mr. Chairman. 

Mr. STUPAK. Thank you, Mr. Deal. 

Next we will hear from Mr. Braley, the vice chair of the subcommittee, a new member of the committee. Welcome. 

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF IOWA 

Mr. BRALEY. Thank you, Mr. Chairman. I just want to tell you 

how honored I am to be serving as your vice chairman. I look forward to working with you and Ranking Member Walden on the important work of the committee. 

As I was preparing for the hearing today, I thought of Upton Sinclair and what he must be thinking as we sit hear nearly 100 years 

after the publication of The Jungle facing the very same food questions that dominated the discussion of this Capitol over 100 years 

11 

ago, and that was highlighted by this advertisement that appeared 

in USA Today where we have the unbelievable aspect of corporations paying thousands of dollars to say ‘‘it ain’t me’’, and as we 

focus on the important topics we are here to talk about today, we 

need to keep in mind the enormous economic consequences to people who are not involved in this contamination as well. 

This recent outbreak of salmonella in peanut products has resulted in the recall of over 1,700 products, one of the largest recalls 

ever under the jurisdiction of the FDA, but this outbreak is not just 

disturbing because of its size. It is particularly troubling because 

of its impact on Americans most vulnerable to tainted food. As 

noted in the Monday issue of USA Today, salmonella affects people 

who are most vulnerable depending upon the strength of their immune system and how old or young they are, and we all know that 

salmonella is most dangerous to very young children. Given that, 

I think it is outrageous that the contaminated King Nut peanut 

butter, which was the product in which the source of this salmonella outbreak was first located, was distributed to nursing 

homes, hospitals and schools. 

Yet the serious concerns I have about the severity of the effects 

of salmonella on children are only compounded by the sheer popularity of peanut butter and peanut butter snacks among children. 

As President Obama noted recently, peanut butter is very prevalent in the diets of young children like his daughter Sasha. As a 

parent, I know this firsthand. I am also concerned as a parent that 

three States have had to remove tainted Peanut Corporation of 

America products from their school lunch programs. These States 

receive peanut butter or roasted peanuts from the Federal Government, which bought them from the Peanut Corporation of America. 

It is completely unacceptable that our Nation’s schools could be 

serving children products that could make them severely ill or kill 

them and that the Federal Government would be purchasing and 

distributing these potentially dangerous products to our schools. 

There are many questions that need to be answered today about 

the practices of Peanut Corporation of America, about the FDA and 

State inspections of their plants, and about the general safety of 

our food supply. One thing that is clear is that we need to be doing 

a much better job of protecting Americans, particularly children 

and other vulnerable populations, from unsafe food products. I look 

forward to hearing the testimony of the witnesses and hope that 

this hearing will help to determine what Congress needs to do to 

prevent these outbreaks in the future and ensure the safety of our 

Nation’s food supply. 

Mr. STUPAK. Thank you, Mr. Braley. 

Mr. Gingrey for an opening statement, please. I guess he is not 

there. 

How about Mr. Burgess for an opening statement? Order of appearance we have been going by. Mr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman. 

Mr. Chairman, it seems like we have been here before. We have 

previously established that there are serious problems within the 

12 

FDA. In the last Congress we had 16 FDA-related hearings. Now 

we begin a new session of Congress with a hearing on the Food and 

Drug Administration and their role in inspecting the Peanut Corporation of America, the source of over 553 salmonella-related illnesses and at least eight deaths. Mr. Chairman, this is like a bad 

movie and we all have read the script before. In 2007, we investigated the Food and Drug Administration’s role with ConAgra and 

the salmonella illness in their peanut-based products, and just like 

today, in 2007 it was the State of Georgia which was the source 

of the salmonella and peanut-based products, so it is not just a bad 

movie script, it is a deadly one, and it has got the same theme, salmonella, the same actors, the Food and Drug Administration and 

the State of Georgia, but with one crucial difference: this time 

there is the possibility of criminal activity by the Peanut Corporation of America. And we know that the Peanut Corporation of 

America engaged in deliberate misconduct in this case. We know 

that the Peanut Corporation of America not only retested salmonella-positive batches of peanut products, they intentionally 

shipped the products to their unsuspecting clients. At least 75 companies, 16 different food categories make over 1,000 types of consumer foods with peanut products made by the Peanut Corporation 

of America and then they put them in front of the whole world for 

our consumption. It is no wonder in the past month, it seems like 

almost on every newscast at the top of every hour we are notified 

of yet another recall of yet another product creating yet another 

crisis, a crisis in an already troubled economy. 

Mr. Chairman, this is a deliberate act that is almost astonishing 

in its cruelty. It is a violation not only of the trust of the American 

consumer but also of their business partners. The president of the 

Peanut Corporation of America could give us answers, should give 

us answers, but we won’t get them today because it is my understanding, that individual is going to plead his Fifth Amendment 

rights. Boy, I would love to ask, how did you think this was going 

to work out for you. 

I also continue to be troubled by how much the Food and Drug 

Administration needs our attention and modernization. They need 

more powers like the mandatory recall power, which I had previously advocated, as well as the power to retrieve all records for 

any food company being investigated. But no matter how much demand greater action and accountability from the Food and Drug 

Administration, we can only hold the Food and Drug Administration accountable for the laws that are there and then businesses 

like the Peanut Corporation of America, they violate not just the 

law but the fundamental tenets of their business practices. It is not 

any longer about following the rules of the FDA. It is just about 

being a good citizen of the world. So for me, yes, it is time again 

to focus on the Food and Drug Administration and how we need 

to work on the Food and Drug Administration and help it in its 

mission but we also should focus on punishing the bad actors in 

this case. 

Mr. Chairman, now it is a criminal matter, and although we 

need to work to continue to modernize the FDA by giving them the 

money and the power they need to continue to protect our citizens, 

you know, there is not a night that goes by it seems that Lou 

13 

Dobbs doesn’t end his newscast by saying, ‘‘Doesn’t anyone deserve 

a government that works?’’ and that is not just a rhetorical question, Mr. Chairman. 

Mr. Chairman, let me ask that this committee answer Mr. Dobbs 

in the affirmative. Let us make it unambiguous. Let us make it a 

bipartisan affirmative and let us also commit that from this hearing forward we will make our actions match our rhetoric, and I will 

yield back. 

Mr. STUPAK. Thank you, Mr. Burgess. 

Ms. Christensen for an opening statement. Welcome to the committee. 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 

REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS 

Ms. CHRISTENSEN. Thank you, Mr. Chairman, and good morning, 

Chairman Waxman, Chairman Stupak, Ranking Members Barton 

and Walden. This is my first hearing with the Subcommittee on 

Oversight and Investigations and I am glad to be here but I am 

really sickened by the reasons that we are meeting this morning. 

The recent salmonella outbreak demonstrated clear and serious 

deficiencies in our country’s food safety system, some based on centuries-old legislation, and so this hearing is very important to fixing the problems that cause so much preventable illness and the 

eight deaths that should not have happened, so thank you for holding it, and thank you also to those who are here to testify, especially the families of those who suffered because of the unscrupulous, likely criminal business practices and the fact that our government failed you. I extend condolences to the Almer and 

Tousignant families, and to Mr. and Mr. Hurley, we are glad to see 

that Jacob is well enough to be here with us today. 

For the past several months we have heard countless reports 

about the salmonella outbreaks, and with each story and each investigation we learn a bit more about how many gaps there are in 

our Nation’s processes to ensure food safety. We have also learned 

how key agencies such as FDA lack the authority, resources and 

oversight that they clearly should have to ensure the safety of our 

food and the health of our families and our loved ones. Finally, we 

have learned about the tragic consequences that these gaps in food 

safety have on innocent lives, consequences that could have been 

avoided, should have been avoided and consequences that I look 

forward to working with you, my colleagues on this committee, to 

avoid in the future. 

Thanks to Mr. Dingell, Mr. Pallone and Mr. Stupak, who have 

already launched an effort that is heading us in the right direction 

with the introduction of H.R. 759, the Food and Drug Administration Globalization Act of 2009, which I am proud to cosponsor. 

Through provisions which empower the FDA with additional resources and mandatory recall authority as well as oversight over 

and access to the safety plans of food service facility established as 

well as access to those tests that are conducted to measure safety 

and inspection records, we are finally on a better path to prevention. We know those measures are too late for the precious lives 

that have been lost and the others that were put in jeopardy, lives 

of some of more vulnerable people, those in nursing homes, hosVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
14 

pitals and schools, all because we had to wait for a company to initiate the recall of a product that they knew was tainted, that they 

knew would make people sick just to protect their profit margins. 

There is plenty of blame to go around because many balls were 

dropped. The only blameless ones in all of this are the individuals 

who died, those who got sick and their families and loved ones. If 

for no one else, let this hearing be about them and let the lessons 

we learn and the next steps we take to ensure that their suffering 

is not forgotten. 

Thank you, Mr. Chairman. I yield back the balance of my time. 

Mr. STUPAK. Thank you. 

Mr. Radanovich for an opening statement, please. 

OPENING STATEMENT OF HON. GEORGE RADANOVICH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. RADANOVICH. Thank you, Chairman Stupak and Ranking 

Member Walden. Also I want to thank Mr. Waxman and Mr. Barton for holding this important hearing on the outbreak of salmonella in peanut products. 

As a representative of one of the largest agriculture producing 

districts in the Nation, I am keenly aware of the importance of food 

safety as a public health hazard and also as an issue of national 

security. However, what truly makes me more concerned about 

food safety, it is not so much my role as a Member of Congress but 

as a father of a 10-year-old boy who happens to love peanut butter 

and jelly sandwiches. Parents these days have so many things to 

worry about. It is unfortunate that peanut products, which are 

often a staple in the diet of a 10-year-old boy, have been added to 

this list. Even with the best parenting in the world, there are some 

things that are out of our control as parents. My wife and I can 

choose to avoid packing my son peanut products in his lunch but 

that doesn’t stop him from trading his granola bar for trail mix 

that has salmonella-tainted peanuts in it. 

My condolences go out to those who have lost your loved ones 

and to those who have been tragically affected by the salmonella 

outbreak, it was an avoidable situation, and I am looking forward 

to hearing the testimony from the witnesses and learning how Congress can help prevent situations like this from reoccurring. 

So I look forward to the hearing and what we might learn from 

it, and Mr. Chairman, I yield back. 

Mr. STUPAK. Thank you. 

Ms. Sutton for an opening statement, 3 minutes. Welcome to the 

committee. 

OPENING STATEMENT OF HON. BETTY SUTTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO 

Ms. SUTTON. Thank you, Mr. Chairman. 

On Christmas Day, my local newspaper had a story about a resident in a Summit County nursing home, that she was very ill, and 

on top of many other medical conditions she suffered from fever, 

abdominal cramps and diarrhea. Doctors diagnosed this woman 

with a case of salmonella, and a few weeks later she died. The 

woman I speak is one of the eight people who died of salmonella 

15 

and is among the 550 people nationwide who became sick as a result of this bacteria. According to the Ohio Department of Health, 

there have been 89 cases of salmonella reported in Ohio in the past 

4 months. This figure is much higher compared to occurrences in 

other States. 

Mr. Chairman, this outbreak demonstrates yet again that our 

food inspection system is broken. The source of the salmonella was 

traced to a factory in Georgia, we have heard, called the Peanut 

Corporation of America, or PCA, and on multiple occasions PCA’s 

peanut products have tested positive for salmonella. PCA still 

shipped their products to schools, nursing homes and stores, despite that. Now there is a document on the FDA Web site with 288 

pages worth of recalled products that include peanuts. The negligent practices in this food manufacturing plant are unacceptable 

and the government must do more to protect Americans. Regulatory agencies like the FDA, they need more power and they must 

execute more power and oversight to prevent another catastrophe 

like this. This is why I reintroduced the Protect Consumers Act. 

This bill is very simple. It would give the FDA mandatory recall 

authority over food products. Mandatory recall authority is only 

one of the critical steps, and there are other bills out there that are 

equally important and more comprehensive but just taking this 

simple step is a step that we should pursue with haste. Currently, 

the FDA is forced to rely on the company at issue to do the right 

thing, and we know that that isn’t a good way to operate. 

I look forward to hearing from PCA to learn why they continued 

to sell their contaminated products. I am also eager to hear from 

government officials to learn about their role in the recall and I 

look forward to working with my colleagues here on the committee 

to fix our broken system so that America’s families can trust that 

the food they are eating is safe. That is not too much to ask. 

Thank you. 

Mr. STUPAK. Thank you. 

Ms. Blackburn for an opening statement, please. 

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

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

hearing, and I want to thank our witnesses for taking their time 

to come before us today. 

As you have heard, FDA review and oversight is not new to this 

committee. This is something that we have gone over and over and 

over during my 4 years on this committee, and Mr. Chairman, I sit 

here and I am listening to the opening statements and looking at 

our witnesses and I think, how many more Americans are going to 

have to be affected by some type of illness or worse before we get 

down to the basics on review, reform and accountability that is 

lacking in the system that is before us. I think it is unacceptable 

for the American public’s health, and indeed, their life in many 

cases to be put at risk. 

Now, peanuts, as you have heard, this is why we are here. This 

is the latest of our contamination issues in our food supply, and it 

is so unfortunate that contaminated product was knowingly 

16 

shipped to various locations, some in my State of Tennessee, and 

indeed, we express our sympathies to the families who have been 

injured, harmed or experienced loss of life because of this. We have 

11 cases that are in Tennessee alone. Indeed, this is something 

that could have been prevented. We all know the source. We have 

discussed that with Peanut Corporation of America. We are going 

to look more into that today. And one thing that I am really going 

to want to know a bit more about is how there could have been 12 

known cases of salmonella between June of 2007 and September of 

2008, how there could have been 12 times that this was known and 

appropriate action was not taken. And what the American people 

are wanting to see is not more rhetoric, they want to see action, 

and Mr. Chairman, I think that is where reforming this system 

comes forward as what our next step should be to make certain 

that the American people can trust us to do our job, to reform the 

system so that they have trust in the food supply and the product 

that is placed on their shelves, and I yield back the balance of my 

time. 

Mr. STUPAK. Thank you. 

Ms. DeGette for an opening statement. Ms. DeGette is vice chair 

of the full committee. 

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

Ms. DEGETTE. Thank you so much, Mr. Chairman. We spend a 

lot of time together in these food safety hearings, and I want to 

welcome our new members of the committee. I have been on this 

subcommittee for 12 years now, and since I have been on this subcommittee this is our 10th food safety hearing at which the members of the Oversight and Investigation Subcommittee spend quite 

a bit of time in a bipartisan way wringing our hands. 

Now, in the meantime, with the latest problem, over 500 people 

have been sickened, 15 of them are in my home State of Colorado, 

half of the sickened people are children, and eight people have 

died. This is the deadliest outbreak of foodborne illness in decades 

but we have seen in the last few years jalapenos, peanut butter 

again, meat, dog food and on and on and on. I guess my question 

is to Congress in general, how many sick kids does it really take 

for us to finally act? How many workers need to get laid off before 

private industry and Congress put resources into protecting the integrity of our food distribution system? And I cannot think of a 

case that better demonstrates the need for the FDA and USDA to 

have mandatory recall authority than this case. The Peanut Corporation of America sells in bulk to companies and then those companies manufacture and distribute processed foods. So even though 

people started getting sick last summer, current federal law does 

not empower public health officials to issue a recall in response to 

an emergency like this. My constituents are shocked when they 

hear this, and instead companies are left to voluntarily decide for 

themselves if and when to recall their products. And so Mr. Chairman I know this isn’t a legislative hearing but I am sure that the 

parents who are sitting here today would like to know that there 

are actually legislators working on these issues. I have introduced 

17 

legislation again this year, which I have introduced many times in 

the past, to finally give the government mandatory recall authority, 

and the good news is, finally this is supported not just by the regulators but also by the industry, and so I think when we pass comprehensive food safety legislation, finally the FDA and USDA will 

have mandatory recall authority. 

The second bill I have reintroduced this year, which I have introduced many times in the past, is the TRACE Act, and what this 

bill does is creates a comprehensive traceability system so that we 

can trace from where the peanuts came from to when they are in 

those little peanut butter crackers that the children are eating, 

where that came from so that we can recall that right away. That 

problem was a particular problem last year with the jalapenos in 

the salsa. I am happy to report that Mr. Dingell and Mr. Stupak 

have included both my mandatory recall language and some 

traceability language in their comprehensive bill and I am also 

happy to report that the regulators support traceability and now 

again the manufacturers are beginning to understand that situation. 

Mr. Chairman, I am eager for this hearing today. We need to 

shed light on this situation, but once we do that, Mr. Chairman, 

I look forward to working with you and Mr. Waxman so that we 

can move legislation and begin to solve these problems. 

Mr. STUPAK. Thank you. 

Mr. Gingrey for an opening statement, please, 3 minutes. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you for recognizing me on 

this, my first hearing as a member of this subcommittee, and I look 

forward to serving under your leadership and that of Ranking 

Member Walden in the crucial oversight role of the subcommittee. 

Let me welcome our former Georgia Speaker of the House and now 

deputy commission of agriculture, Terry Coleman, as well as Mr. 

Oscar Garrison, the assistant commissioner, who I certainly look 

forward to hearing his testimony on the third panel 

Now, I first want to express my sincere condolences to the families that are here today and those families across the Nation who 

have either lost a loved one or have suffered illness as a result of 

this salmonella outbreak. For those testifying today, I appreciate 

your willingness to come before this subcommittee and share your 

stories, as difficult as it may be, with us. All of us have a responsibility to learn from this tragedy and to take the necessary steps to 

ensure that no other family has to ensure what you have experienced. 

Mr. Chairman, it is regrettable to see that the facility under investigation today is located in my home State of Georgia and it is 

also unfortunate that Mr. Parnell and Mr. Lightsey from PCA, the 

Peanut Corporation of America, will likely refrain from testifying 

in accordance with their Fifth Amendment rights. And while they 

are within their Constitutional rights, I would offer this admonition 

to them and to anyone else who makes the products that our citizens and their families consume: If you circumvent the law or 

merely take advantage of lax oversight, don’t think you have 

18 

gamed the system forever because justice will catch up to you and 

you will pay. Further, if the circumstances as presented and reported to this point bear out to be true, then it seems the decision 

to achieve shortsighted profits has trumped common sense and morality. For this, there will be an accounting. 

Mr. Chairman, as we in Congress move forward, we must also 

recognize that no matter how high a regulatory wall we erect, there 

will always be someone who is brazen enough or stupid enough or 

greedy enough to try and climb over that safety barrier, and 

though our gut reaction might be to build an even higher wall, we 

have an obligation to thoroughly evaluate and ensure that current 

law was properly enforced first. The wall’s integrity, after all, 

comes not from the height, Mr. Chairman, but from its foundation. 

So as we proceed with this hearing, I will listen carefully to the 

witnesses and their statements and their responses to the questions in the hope that we will get to the bottom of this tragedy. 

Mr. Chairman, with that I yield back. 

Mr. STUPAK. Thank you, Mr. Gingrey. 

Again, by order of appearance at the subcommittee, Mr. Welch 

from Vermont. Welcome to the committee, and you are always welcome to come sit up here on the top row too. 

OPENING STATEMENT OF HON. PETER WELCH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF VERMONT 

Mr. WELCH. I hear the air is pretty good up there. 

Thank you very much. I want to echo what Mr. Gingrey said and 

express my condolences, and believe me, it is very kind of you to 

come here and it makes a real difference that you are willing to 

share your story, painful as it is, and I apologize that we have 

added to your burden by making you sit through so many opening 

statements. But, you know, I have been listening to them too and 

there is something that I find quite heartening in this. We all 

agree that what Peanut Corporation of America did was despicable 

and outrageous and they should be held to account. But what you 

as parents, as sons have a right to expect from your government 

is that we have systems in place that give you the assurance that 

when you buy food, it is safe. It is as simple as that. And obviously 

there is nothing worse as a parent to see a child who is sick and 

we don’t know what the outcome is going to be or to lose a parent 

before his or her time. And I am heartened by what I have heard 

today from the members of this committee and also I was earlier 

at the meeting of the whole committee when I heard our chairman, 

Mr. Towns, and our ranking member, Mr. Issa, both expressed the 

commitment to having vigorous oversight, and that doesn’t change 

just because we have had a new change in Administration because 

there are unscrupulous folks out there who for a quick buck will 

put in peril people that you love, and it is our mutual responsibility 

to do every single thing we can to have systems in place that give 

you the assurance that the food you buy is safe, and what you are 

doing, and we so appreciate, is your coming forward with your personal story that makes it real, that makes it vivid, and that is at 

some personal inconvenience and pain to you, so I join my fellow 

committee members in thank you for your service. 

Mr. STUPAK. Thank you, Mr. Welch. 

19 

Mr. Sullivan for an opening statement, 3 minutes, and welcome 

to the subcommittee. 

OPENING STATEMENT OF HON. JOHN SULLIVAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OKLAHOMA 

Mr. SULLIVAN. Thank you, Chairman. I appreciate it. 

As a new member of the Oversight and Investigation Subcommittee, I would like to thank Chairman Stupak and Ranking 

Member Walden for holding this hearing this morning. It is an 

honor to be named to this prestigious subcommittee. I am pleased 

to be part of this important discussion on food safety and look forward to working with each of you as we move forward in the 111th 

Congress. Unfortunately, the salmonella outbreak has hit my state 

of Oklahoma. According to the Oklahoma Department of Health, 

three adolescents contracted salmonella due to the tainted peanut 

butter. One of those adolescents was from Rogers County which 

borders my district. Fortunately, they are all recovered but this 

serves as a reminder that we must take every precaution necessary 

to keep our food safe. 

In late 2008, the Centers for Disease Control identified an outbreak of salmonella affecting 600 people in 43 States with the recent outbreak perhaps contributing to eight deaths. This is an issue 

that affects each and every one of us, our friends and our families. 

It is clear that the food companies and the FDA have a shared responsibility in keeping our food supply safe and secure, and I look 

forward to their recommendations on how to do that in light of the 

recent salmonella outbreak. 

Thank you in advance to our panels before us today, and my condolences to those who have lost loved ones in this unfortunate incident. I look forward to the hearing and testimony of our witnesses 

to get to the bottom of this incident, and I yield back the balance 

of my time. 

Mr. STUPAK. Thank you, Mr. Sullivan. 

Mr. Markey, a member of the subcommittee, for a statement, 

please. 

OPENING STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF MASSACHUSETTS 

Mr. MARKEY. Thank you, Mr. Chairman, very much, and thank 

you so much for having this hearing. 

Peanut butter is a classic American food enjoyed by young and 

old alike, and when it is contaminated by a dangerous pathogen, 

it is something that sends chills through every family in America 

because there are few things more American than peanut butter, 

perhaps baseball of course, but this week we learned that there too 

was a positive test for steroids, and salmonella poses a serious 

health risk as well. So this requires an ongoing effort by this Congress to ensure that in all of these cases that there is no contamination of these things that Americans take for granted as being 

American. Peanut butter goes well with jelly but not with salmonella. Peanut butter was probably half of my diet as a child. It 

is one of those foods that is really good for you and tastes great 

20 

too, but now mothers and fathers across America are worried about 

salmonella and don’t know what to put in their kids’ lunches. This 

is not good for our country. More than 1,800 food products have 

been recalled including crackers, snack bars, cookies and all sorts 

of other items made with peanut butter that may contain the disease-causing bacteria. Salmonella already has had an impact on 

hundreds of families. 

The FDA under the Bush Administration failed to take steps necessary to ensure the safety of our food supply. We learned once 

again with this recall that mandatory authority is required. When 

it comes to food safety recalls, we need mandates and not maybes. 

We cannot run the risk that we will see families across this country once again afflicted with this kind of a problem. The families 

who testify here today, and we thank you for that, represent millions of other frightened families across this country, and your 

story is their story. Your story represents this fear that a parent 

can be lost, that a child can be sickened by a product which they 

assume is safe because the Federal Government is ensuring that 

it is safe by putting the fear of the government into the hearts of 

those that produce products like peanut butter and peanut butterrelated products. That did not exist and that is why you are here 

today. We thank you for your courage in testifying today. I can 

promise you that your testimony today will result in the changes 

that will protect millions of families in our country. 

I yield back the balance of my time. 

Mr. STUPAK. Thank you, Mr. Markey. 

Ms. Schakowsky for an opening statement, please. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Peanut butter. Peanut butter. Is there a kitchen that doesn’t have peanut butter, is there a lunchbox that doesn’t 

have peanut butter sandwiches at some point? It is actually more 

American than apple pie. But what I really find amazing is that 

it was known by the Peanut Corporation of America that their 

product was tainted with potentially life-threatening salmonella 

and yet released into the food stream anyway. How could that possibly happen? The only explanation is they thought based on some 

reality, given the lax regulation of the last Administration, that 

they would get away with it. 

I am so sorry to the testifiers and the families that are here 

today that were burdened by this, afflicted by this, tortured by this, 

that your government failed you, and I am grateful to the chairman 

for holding this hearing today so that we can set in motion those 

safeguards that will never let that happen again and to hold accountable the people that made the decisions that allowed it to 

happen. In one of the most developed nations in the world with access to unparalleled technologies and resources, there is simply no 

excuse that we can offer to you that contaminated or otherwise unsafe food made it all the way to consumers and to your tables. 

I have been a food safety advocate since 1969 when I a young 

group of housewives got together to get freshness dates on food. We 

led a little housewives’ campaign that has resulted in dates, expiraVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
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tion dates, sell-by dates being on food throughout our marketplace, 

and yet today we find that this could happen. So I thank the panel 

before us right now for being here to testify. 

I want to just mention that one of the laboratories, Deibel, is in 

my district. I have been told by the committee that they were very 

cooperative with the committee. I appreciate that and look forward 

to their testimony as well and want to join with my other colleagues in assuring you that we will act to make your families safe 

from this kind of potential killer. Thank you. 

Mr. STUPAK. Well, thank you. That concludes the opening statements of members of the subcommittee. I noted once for the record 

Mr. Barrow is here. He is a member of the full committee. Do you 

have an opening statement you would like to submit? 

Mr. BARROW. Well, first off, thank you, Mr. Chairman, for holding this hearing and for allowing me to audit these proceedings as 

though a member. I have very little to add to what has been said 

before but I will add very little. 

Mr. STUPAK. Very quickly, because you are not allowed opening—— 

Mr. BARROW. It seems to me that in addition to the provisions 

that have been talked about before that are part of a comprehensive reform, things like mandatory recall authority, one thing we 

very badly need is a testing regime in the industry in which folks 

are required to test and know what they need to know and a mandatory contemporaneous reporting requirement so that the regulators will know what the processors know when they know it. I 

think that would add great teeth and great effectiveness to any 

mandatory recall authority, and that is what I look forward to exploring with other members on the panels later on. 

Mr. STUPAK. Well, thank you. We discussed that certification of 

labs and testing before and it is part of our global bill, and we 

would love to have you on the bill. You will be allowed to ask questions later as we move on. 

Mr. Bishop, we already have your opening statement. A valuable 

Member of the House, while not part of the committee, we appreciate you being here and monitoring the proceedings. Without objection, Mr. Bishop’s statement will be made part of the record. 

[The information was unavailable at the time of printing.] 

Mr. STUPAK. As I said, that concludes our opening statements by 

members. I would now like to have our first panel of witnesses to 

testify. First we have Mr. Jeffrey Almer of Savage, Minnesota, 

whose 72-year-old mother, Shirley, died after eating salmonellacontaminated peanut butter at a nursing home—I should also note 

he has a photograph of his mother that I am sure he will explain 

to us as we move on; Mr. Lou Tousignant of Minneapolis, Minnesota, whose 78-year-old father, Clifford, died after eating salmonella-contaminated peanut butter at a nursing home, and Mr. 

Peter K. Hurley, a police officer from Wilsonville, Oregon, whose 3- 

year-old son, Jacob, was severely sickened by salmonella after eating Austin crackers. 

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

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

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

wish to be represented by counsel, gentlemen? OK. Everyone indiVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00027 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
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cates no. I am going to ask you to rise and raise your right hand 

to take the oath. 

[Witnesses sworn.] 

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

the affirmative. You are now under oath. We will begin with your 

opening statement. If you don’t mind, Mr. Almer, would you begin, 

please, 5-minute opening statement, and we appreciate you all 

being here and coming here. 

TESTIMONY OF JEFFREY ALMER, SAVAGE, MINNESOTA; LOU 

TOUSIGNANT, MINNEAPOLIS, MINNESOTA; AND PETER K. 

HURLEY, WILSONVILLE, OREGON 

TESTIMONY OF JEFFREY ALMER 

Mr. ALMER. Thank you, Mr. Chairman and committee members 

for inviting me to testify today. My name is Jeff Almer and I am 

here today on behalf of the family of Shirley Almer, my mother, 

and as a member of S.T.O.P., Safe Tables Our Priority, a nonprofit 

organization that represents foodborne illness victims nationwide. 

My sisters, Vickie and Ginger, are also with me today. 

Shirley Almer had a lot of Sisu, which in her Finnish heritage 

describes a person with spunk, fortitude and determination. That 

is why her death on December 21 from all things salmonella-contaminated peanut butter came as such a shock to our family. 

In May of 2007, Mom had a couple of dime-sized spots of cancer 

diagnosed on her right lung. She decided to have it removed at the 

University of Minnesota and was subsequently diagnosed cancerfree. She took a family trip to Florida a year later to celebrate with 

her children and grandchildren, and it was such a joy to see her 

enjoying life after that terrible scare. 

Then in July 2008, she suffered a seizure and was diagnosed 

with a brain tumor. The prognosis was hopeful and she was determined to do whatever it took to beat cancer for a second time. A 

second seizure robbed her of movement and speech capabilities. 

She underwent brain radiation and a gamma knife procedure. She 

was required to stay at the University Hospital but fought back 

through rehab and regained the use of her limbs and her speech 

despite the diagnosis of some doctors. It was sheer determination 

and a can-do attitude she overcome all of that, never complaining. 

One of her wonderful rehab nurses told me she was a shining light 

and said she was absolutely amazed at the recovery. Mom was released in early October to recuperate with her family and was once 

again declared cancer free. She made plans. She bought Christmas 

presents. She wanted to get another puppy. She wanted to visit her 

sister Mary in Arizona and she was looking forward to being 

around to watch her grandchildren grow up. 

Unfortunately, she suffered a urinary tract infection around 

Thanksgiving and needed to check in short term to a rehab care 

facility for treatment. Her short stay was supposed to end the Monday prior to Christmas when she would then join the family for the 

holidays. She began to complain of stomach cramping and had diarrhea. There was a downward spiral from that point on. Our family 

was absolutely stunned to learn on the day before her scheduled 

release that doctors were giving her hours to live. It was very unexVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
23 

pected and equally hard to fathom how she could have gotten to 

this point. We were devastated as we ended up saying our tearful 

goodbyes and watching her last breaths on that Sunday. 

It was just after the New Year that my sister Ginger was informed by the Minnesota Department of Health about the positive 

test for salmonella. A week before her death she had unknowingly 

consumed salmonella-laced peanut butter while in her immunecompromised state of health. Cancer couldn’t claim her but peanut 

butter did. Now that we understood the cause of her death, our 

grief was replaced by anger as we struggled to accept this preventable tragedy. Our family feels cheated. My mom should be here 

today. 

Her death and the deaths of seven others could have been so easily prevented if it were not for the greed and avarice of the Peanut 

Corporation of America. PCA appears to be more concerned with 

squeezing every dollar possible at the expense of sanitary conditions and sound food manufacturing processes. Every company 

needs to have a moral and ethical compass when producing the Nation’s food supply. In this absence, we need a cohesive regulatory 

system to serve as our safety net; too often it is reactive, if at all. 

While they were not expecting to kill anyone, PCA now has the 

blood of eight victims on their hands along with the shattered 

health of a known 600 others, and they have devastating their own 

community with the unemployment. Their legacy is now that of a 

company that did what it could get away with until their shoddy 

practices has led to the Nation’s largest recall. Their behavior is 

criminal, in my opinion. I want to see jail time and I want to see 

them served nothing but the putrid sludge they have been trotting 

out. I don’t believe anyone in this country buys all the protests of 

innocence they have been saying. 

Shirley Almer loved this country but was terribly let down by a 

broken and ineffective food system with abysmal oversight. She 

was let down in the worst possible way by the very government 

whose responsibility it is to protect its citizens’ health and safety. 

We cannot continue to ignore the public health threat caused by 

poorly regulated and contaminated foods. We cannot allow food 

safety to be continually underfunded and expose unsuspecting 

Americans to deadly pathogens. 

This brings up many important questions. How much time and 

money will end up being spent on the act of recalling over 1,000 

food products? What about the lost productivity and medical expenses for the sickened? When we will have a proactive instead of 

a reactive system? And my last question would be, when will all 

these painful deaths and sickness stop being collateral damage? 

The government and the industry need to work together to correct a multitude of problems. I am proud to be asking for change 

on behalf of my mother, Shirley, and on behalf of S.T.O.P. Although this country has many important issues right now, I am 

urging President Obama and distinguished Members of Congress to 

make the safety of our Nation’s food supply a priority. It is imperative that Americans trust that their health is not compromised by 

the food on their plate. 

We love you, Mom, and we miss you every day. Thank you very 

much. 

24 

[The prepared statement of Mr. Almer follows:] 

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Mr. STUPAK. Thank you, Mr. Almer. 

Mr. Tousignant, your opening statement, please. If you want to 

submit a longer statement for the record, it will be included. If you 

would, please, Mr. Tousignant. 

Mr. TOUSIGNANT. Before I begin, Mr. Chairman, would you start 

the video, please?[Video] 

TESTIMONY OF LOU TOUSIGNANT 

Mr. TOUSIGNANT. Mr. Chairman, members of the committee, my 

father was a highly decorated Korean War veteran. He fought in 

many difficult battles in his years in Korea and was awarded three 

Purple Hearts for his valor. He faithfully served his country for 

over 22 years and he loved every minute of it. The only thing that 

he loved more was his family. 

He was the proud father of six: Paul, with me here today, Marshall, Susan, Calvin, Jane and myself. As you can see by those 

photos, he loved spending time with his grandchildren and his 

great-grandchildren. He had 15 grandchildren and 14 great-grandchildren. 

But he was a man that physically and psychologically scarred 

from Korea, and early on it was difficult for our family, but like 

most battles in his life, he overcame it, so much so that he became 

one of the most generous men that many had known. The night of 

his funeral, I was having a conversation with my brother-in-law, 

Dan Herrick, almost with me today, and he shared a story with me 

of when he and my sister were first married. Like most young married couples, times were tight back then and my father knew that, 

and he would invite them over, make up a story saying my car 

starter won’t work right, something is wrong with the brake, something is wrong with the door, come on over and take a look at it. 

And he would always give Dan and my sister Jane a little something for the trouble of coming over. He helped a lot of through the 

years including his own parents when he joined the Army as a 

teenager. He sent money back home because times were tight then 

as well. As long as he had a few dollars in his pocket, he was more 

than willing to help anyone. 

His final battle occurred in December of 2008 when he ate some 

contaminated peanut butter from PCA. He suffered for weeks until 

he finally died on January 12, 2009. He had just entered a full-time 

healthcare facility in Brainerd, Minnesota, a month earlier. He had 

few goals left in life except for one: he wanted to live to be older 

than his father. He wanted to live to be 80 years old. He was 78 

when he died, a year and a half too early. 

We can’t be certain of how many years Dad was robbed of, and 

because of the way he died, because of all the media attention, our 

grieving process has been different than most. We should not be 

sitting here in front of you today, any of us. We can no longer pick 

up the phone and ask him what game he is watching today. My 

nieces and nephews can no longer crawl over to Grandpa and have 

their photos taken with him. My brother Marshall and my sisterin-law Ann, who were fortunate enough to spend the last 3 1/2 

years with him, can no longer go to his house daily and just check 

in and see how he is doing. My brother Paul, who spoke with him 

frequently, can no longer call him just when he feels like. He has 

29 

trouble sleeping at night now, not just because we lost our father 

but the senseless way that this happened. 

What happened to our father, the seven other families like the 

Almers, the over 600 others sickened like the Hurleys is not new. 

Over the years there have been hundreds of similar outbreaks and 

other heartbreaking stories. Why has this been allowed to happen? 

Two years ago the Peter Pan outbreak affected more than 600 people in 47 States. Two years later, here we are again asking for 

change. 

I submit to you, ladies and gentlemen, how can we truly be leaders of the free world if we can’t keep our own citizens safe from 

the food that we eat every single day? We have a blind faith that 

when we go to a grocery store, the food there is also safe. Clearly 

it is not. 

Do not let the death of my father, the seven others and hundreds 

sickened by in vain. Please do your job. Do not let us be back here 

next year or the year after experiencing the same thing. Companies 

like PCA and Mr. Parnell who make our food should have rules 

that they live by. Companies should be inspected more than once 

every 5 years. Companies should not be allowed to shop around for 

lab results. Companies like King Nut should not be allowed to slap 

a label on their product they received from a factory that they 

know nothing about, never visited nor even ever inspected once. 

The FDA should also have the right to recall contaminated food 

themselves and not wait for companies to do so on their own. We 

can’t allow the number of FDA inspectors and inspections to continue to decline. 

My father was a good man. He faithfully served his country. The 

system that was set up to protect all of us here today has failed. 

My father died because he ate peanut butter. 

[The prepared statement of Mr. Tousignant follows:] 

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Mr. STUPAK. Thank you, Mr. Tousignant. 

Mr. Hurley, your testimony, please. 

TESTIMONY OF PETER K. HURLEY 

Mr. HURLEY. Good morning, Congressmen, Congresswomen and 

committee members. My name is Peter Hurley. My wife Brandy 

and I are parents of three children: Lauren, 5, Jacob, 3, and 

Alyssa, 8 months. I am a police officer in Portland, Oregon, and my 

wife is a marketing manager. 

Our whole family, baby and all, have traveled from Oregon to 

Washington, D.C., to testify before you regarding the salmonella 

outbreak that has affected us as well as hundreds, if not more likely, thousands, of fellow Americans. 

I want to take a moment to acknowledge the eight families who 

have lost loved ones. Eight people have died due to PCA’s willful 

negligence. We were just lucky. It could have been very different 

for us. 

We made this journey to appear before you because we felt it important enough for you to hear our story of how the Peanut Corporation of America poisoned our son. We want you to hear how 

Jacob and a PCA-supplied product are genetically linked in the 

hopes that you will take action to protect our food supply. 

Jacob’s story began with him becoming ill with diarrhea and 

vomiting in early January. He was sallow, lethargic and probably 

had a fever that we missed. In a few days he began to have blood 

in his diarrhea. We took him to the pediatrician. A few days later 

the pediatrician called to let us know that the lab results had come 

back and that Jacob had salmonella poisoning. At this point we did 

not know how Jacob got the poisoning, and because of that, we did 

not know how to protect the rest of the family. All we knew was 

that five or six people had already died in a new salmonella outbreak. At that time only King Nut peanut butter, a PCA product, 

was listed as a source, which we did not have. What had we unknowingly given him that had given him salmonella poisoning? 

As Jacob’s diarrhea continued, my wife was given the oK from 

our pediatrician’s office for Jacob to eat his favorite comfort food, 

Austin toasty crackers with peanut butter, the very food that we 

later found was the cause of his poisoning, so here we have a boy 

who is trying to get over food poisoning and one of the foods that 

was seen safe even to the people in the pediatric medical community is the exact product that is continuing to poison him. 

A week later, Dr. Bill Keene from Oregon’s Office of Disease Prevention and Epidemiology came to our house at 5:00 on a Saturday 

night. As a friend said, this is like having the head of the FBI coming out to take fingerprints. On that Saturday night, Dr. Keene 

took custody of our supply of Austin toasty crackers with peanut 

butter manufactured by Kellogg’s with a PCA product. One week 

later, Dr. Keene called us to say that Jacob and the crackers he 

had taken from our house had an exact DNA subtype match for 

salmonella. Three out of the six packages of crackers he tested 

were positive, and that was all that we had left. The issue was no 

longer what had we done unknowingly but what had PCA done 

knowingly. 

33 

Jacob continued to have diarrhea for 11 days. We had to be extremely vigilant to ensure that there was never any cross-contamination between Jacob and Alyssa, our 7-month-old. If Alyssa had 

come down with salmonella poisoning, there is a good chance that 

we would be one of the families who had lost a loved one due to 

PCA’s willful negligence. 

I have read the FDA’s most recent report. This was not an accident. It sickens me to know that a company and its employees 

could knowingly allow tainted product to go out the door and into 

the Nation’s food supply. Does no one have a conscience anymore? 

People would be in utter outrage if they heard of a police officer 

putting a loaded gun to someone’s head, pulling the trigger, and 

then in the horrific aftermath say it was just that the bullet in the 

chamber wouldn’t fire. We, the United States, are the first world. 

Have we fallen to second world food status for our food safety? As 

the woman taking care of our dog while we are here in D.C. said, 

‘‘Even my dog is not safe. What is this, China?’’ 

Where do we go from here? We need to have a faster 911-oriented medical response for food contamination in order to prevent 

further innocent victims. We need FDA inspectors out there with 

the authority to stop production immediately when there is a problem. We need the FDA to have the ability to criminally prosecute 

quickly and effectively. Oregon has the dubious distinction of suffering the first-ever domestic terrorism in the United States. It was 

carried out by the Rajneeshees in the 1980s. They sprayed a salad 

bar in The Dalles, Oregon, with salmonella. If a small group of religious fanatics in Oregon could pull it off, who else could? 

None of us should be so naive as to think that Al-Quaeda could 

not easily taint our food supply. If the very well-funded Al-Quaeda 

could put it mind to it, I shudder to think of what could happen 

to this country when people do not know where to turn to find safe, 

uncontaminated food. The panic, pandemonium and lawlessness 

would be horrific. 

I will leave you with my favorite quote by the 19th century author, poet and philosopher, Johann Wolfgang Goethe: ‘‘Few men 

have imagination enough for reality.’’ On behalf of all Americans, 

my whole family, Jake and I ask you to please have imagination 

enough to think of the worst-case scenario and to work to protect 

against it. Thank you. 

[The prepared statement of Mr. Hurley follows:] 

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Mr. STUPAK. Thank you, and thank you to this panel for not only 

being here but also sharing your story and your video to put a 

human face on this latest recall we have. I would like to express 

my condolences to you, Mr. Almer, and to you, Mr. Tousignant, and 

Mr. Hurley, we are glad that Jacob is doing better and it is good 

to have your whole family here. Thank you for being here. 

As family members and victims of this outbreak, I am sure that 

you have asked yourself the same questions I have asked myself: 

What was this company thinking releasing tainted product to the 

public. During our investigation, the committee requested and received internal e-mail from PCA relating to the outbreak and past 

testing for salmonella. I would like to ask you about some of these 

documents. Mr. Hurley, right in front of you is there book, the document book. Let me ask you this. On October 6, it is tab #43, if 

you want to open it up there. Tab #43, on October 6, 2008, Stewart 

Parnell, president of the Peanut Corporation of America, responded 

to news from Sam Lightsey, the manager of PCA’s plant in Blakely, 

Georgia, as tab #43 says, Mr. Lightsey had informed Mr. Parnell, 

‘‘We received final lab results from Deibel this morning and we 

have a positive for salmonella.’’ Mr. Parnell’s response was as follows, and again, it is found there in tab #43: ‘‘We need to discuss 

this, the time lapse. Besides the cost, it is costing us huge...’’ and 

there are dollar signs ‘‘and causing obviously a huge lapse in time 

from the time we pick up peanuts until the time we can invoice.’’ 

And in there you see there are five dollar signs. Let me ask each 

of you, what is your reaction to this company responding to positive 

salmonella testing with concern about its own financial well-being? 

Mr. Hurley, do you want to start? 

Mr. HURLEY. Not to sound trite or overly confident, but as a police officer, I can unequivocally say that it is criminal. 

Mr. STUPAK. Mr. Tousignant? 

Mr. TOUSIGNANT. An act that is this egregious, I completely 

agree with Mr. Hurley. I mean, this is a completely criminal act 

that in essence he was really playing Russian roulette with children and the elderly when he sent this peanut butter out. 

Mr. STUPAK. Mr. Almer, do you care to comment? 

Mr. ALMER. When I came here today, I didn’t think I could possibly get more outraged than I already am about how this happened, but I have to tell you, it has reached another level after seeing e-mails and comments from Mr. Parnell. No excuses. 

Mr. STUPAK. On tab 46, there is another tab in there, another email, and let me just—there are other faxes and e-mails the committee has uncovered but you indicated that it was criminal, Mr. 

Hurley. Being a former police officer myself, I am identifying with 

you. The Justice Department is doing their investigation. There are 

certain things that our committee could and could not bring out at 

this time, so I want to assure all of you that there still is a criminal 

investigation going on. 

You also mentioned about your dog and the sitter taking care of 

it saying, ‘‘What are we, China?’’ Well, in 2006 some of those peanuts that were positive came from China, so it is a global problem. 

But let me ask you this, #46, tab 46, even after several weeks 

into this outbreak, Mr. Parnell was asking the FDA whether it 

could use peanuts from its plants. Here is what they wrote to the 

41 

FDA, ‘‘Obviously we are not shipping any peanut butter products 

affected by the recall but desperately at least need to turn the raw 

peanuts on our floor into money.’’ So we have at least two e-mails 

here in which Mr. Parnell reacts to the outbreak by worrying about 

how money it is costing him. Any comments on that? Mr. Hurley. 

Mr. HURLEY. Narcissistic, I would say, maybe. 

Mr. STUPAK. OK. Mr. Tousignant? 

Mr. TOUSIGNANT. I am at a loss, personally. I mean, I just can’t 

see how anyone could run a business and be a member of a community and maybe even belong to a church in that community and be 

making decisions not only like this but also putting jobs in that 

community as well in a very, very tight environment like this too. 

Mr. STUPAK. Mr. Almer? 

Mr. ALMER. I would expect that if you are making food, you 

would want to eat that food that you are producing, and I don’t believe that Mr. Parnell would actually want to eat this product if he 

is producing food in that manner. 

Mr. STUPAK. Well, thank you, and again, let me thank you for 

coming here and sharing your stories. I know it is difficult, but we 

need to have the human face because people have to see. They just 

think we have these hearings but there is a reason for these hearings and that is so people see what happens when frankly a number of people let us down but including our own government. That 

concludes my 5 minutes for questioning. Mr. Walden for questions, 

5 minutes, please. 

Mr. WALDEN. Thank you very much, Mr. Chairman. As we have 

sat here, I have been updated that now in Oregon we have 12 labconfirmed reports of salmonella, and also as I referenced in my 

comments, they now have confirmed the dog and the dog biscuits 

from the household were positive as well, so Mr. Hurley, I believe 

it was you who said somebody is watching your dog. We now know 

that it is there as well. 

I wonder of Mr. Parnell is in the audience. Is Mr. Parnell in the 

audience? You know, I would think that the least he could have 

done was be here to hear your comments and to hear about your 

loved ones, like a victim impact panel, because that is really what 

this is today. 

Mr. Almer, I will be asking Mr. Parnell, as I mentioned in my 

opening statements, and I appreciated the comment about Russian 

roulette because that is really what this is about is, which of these 

would he eat and his company because they sure put it out there 

for your mother and your father and, Mr. Hurley, your son, and all 

the rest of us to consume, and I wonder if he will take the top off. 

We are going to give him that opportunity. 

Mr. Hurley, from your written testimony it seems like you were 

pleased with the State of Oregon’s response to your son’s illness. 

Can you tell me what Oregon did that was helpful to you and may 

serve as a model for other States? What out of that experience can 

you share with us? 

Mr. HURLEY. At the time when Dr. Keene came to our house, I 

was unfamiliar with his rank and status and—— 

Mr. WALDEN. As the state epidemiologist. 

Mr. HURLEY. As the state epidemiologist. Exactly. And since then 

I have learned, as my friend said, it is kind of in terms of rank like 

42 

having, you know, the director of the FBI come by to take latent 

fingerprints. What he did though is unique for the whole country, 

and that is that Jake is the only person in the whole country where 

you have a DNA link between the product, the Austin peanut butter crackers, and his lab samples. Sorry for the crassness, but it 

was lab fecal samples. And it is an exact DNA match so that they 

know that the peanut butter crackers that he ate that went 

through his system is what made him sick, and Jake is the only 

one in the whole country and that is because Dr. Keene came to 

our house at 5 p.m. on a Saturday night on his own time while running errands because he was concerned enough about where this 

was going and what was happening that he then took those samples, sent them off to the lab and he said that the lab spent lots 

of time and lots of hours and money on it to find that link, and 

with that kind of a link, then they had a batch number and a processing number that they were able to contact Keebler with directly. 

Mr. WALDEN. And as far as you know, that wasn’t done anywhere else in the country? 

Mr. HURLEY. To this date when I—I spoke to him last on Friday, 

I believe it was, and at that time nobody else had any direct links, 

and as he said, most States don’t have the manpower or money to 

do that, and also it seems as if most State epidemiologists, they 

know that people have gotten sick because they get that from the 

county health records and then they work on the other side looking 

at the lab results of product out there or voluntary lab results but 

they don’t put the two and two together by looking for product at 

its location. 

Mr. WALDEN. I would say too as my staff was collecting this assortment of products that are on the recall list, we ran into even 

in some of their homes items that are on that list that frankly they 

thought had already been thrown out, destroyed, whatever, and 

sort of beyond this hearing but in real time, people may still have 

products at home that should be destroyed, and as we were chatting here, just the breadth, the scope of the items that are out 

there, what would you—Jacob suffered through this. Certainly as 

apparent, and I, like you, am a parent, but what should we be telling people across the country today about this? 

Mr. HURLEY. I don’t know what we should be telling them but 

I do know that one of the tough things in this has been getting all 

the products off the shelves. I know that locally in Oregon there 

was a story done where they went to some small local markets 

where people weren’t getting their product directly from a supplier, 

they were going out and purchasing themselves, a small mini market kind of situation, with lots and lots and lots of products on the 

shelf, and, you know, how do you get that word out when it is voluntary. There is no system in place to get the word out to all these 

retailers of all these different products. 

Mr. WALDEN. Did you do searches online looking for products 

once you started down this process? I mean—— 

Mr. HURLEY. No. You know, we gave up our supply of peanut 

butter crackers to the doctor and after that, as he said, you know, 

just don’t eat anything with peanuts in it or any peanut products 

until we know more down the road, and so, you know, we have got 

43 

stuff still in our pantry but it is sitting there waiting to kind of see 

how this develops because I know it will be a little bit longer. 

Mr. WALDEN. I guess that is the concern is everything in the 

pantry, and it is amazing to me how much of what we consume has 

some peanut or peanut paste or something in it that may well be 

on this list. 

Thank you, Mr. Chairman. Thank you, Mr. Hurley. 

Mr. STUPAK. Thank you. I just want to let you know, as of last 

night, the Republican cloakroom still had the Keebler peanut butter crackers in there. Mr. Shimkus brought it to our attention, and 

I think we got it out of your cloakroom. 

Mr. WALDEN. Yes, they are supplied by the Democrats in a conspiracy. 

Mr. STUPAK. Just trying to help. 

Ms. Christensen for questions, please. 

Ms. CHRISTENSEN. Thank you, Mr. Chairman, and again, thank 

you and your families for being here this morning and for sharing 

these painful stories with us. 

Do you have any concerns about the speed with which they outbreak was linked to peanut butter by public health officials? We 

have focused a lot on the company itself but I want to just turn 

the focus to our response as a government. 

Mr. ALMER. I would like to add that my mom at the peanut butter some time in mid-December and the salmonella outbreak was 

known about in early September, so the time it took to find out the 

cause could have prevented a lot more of the problems that happened. 

Ms. CHRISTENSEN. I just have another question that either of you 

could answer or all of you. I will preface it by saying that as a physician I used to do drug testing on ships coming into port and so 

forth, the people that worked there, and I had to ascertain by temperature that this person gave me the sample and I had to be responsible for the chain as it went from the ship to the lab. So I 

have a lot of concerns about the second lab test, whether the second samples were from the same batch, especially with positive 

tests going back to 2007. Do you think it is good enough for the 

company themselves to be the ones collecting, contracting for the 

testing and reporting the results? Shouldn’t that be fixed? 

Mr. TOUSIGNANT. Well, I think clearly in this case that is definitely the key. I mean, clearly the company could not be trusted 

to do it on their own. Now, I know that there are probably a lot 

of companies that are running an ethical business, but unfortunately, we have to worry about the ones that are not, and we have 

to have a process in place that allows us to be in charge of that. 

Ms. CHRISTENSEN. Thank you. I don’t have any other questions 

for this panel, Mr. Chair. 

Mr. STUPAK. Thank you, Ms. Christensen. 

Mr. Deal for questions, please, 5 minutes. 

Mr. DEAL. Well, I too express my sympathy to all of you for the 

loss of your family members and certainly the trouble that your 

young son has undergone. We have heard Mr. Hurley talk about 

his interaction with his State epidemiologist. Would the other two 

of you elaborate on any contact you may have had with health auVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00049 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
44 

thorities? For example, did any of you get contacted by the CDC, 

et cetera? 

Mr. TOUSIGNANT. My brother, actually Marshall, was contacted 

by the State of Minnesota and we found out, I wan to say about 

a week after the fact after my father died or maybe a few days 

after he died that indeed he did have salmonella and they actually 

found it in his blood. 

Mr. ALMER. It was about 2 weeks after my mother died that my 

sister Ginger received a call from the Minnesota Department of 

Health if we had brought in any kind of food from the outside, had 

she eaten chicken, had she eaten peanut butter, and it was my sister who remembered she had served my mother peanut butter 

toast two times. That really became a huge key to finding out—actually I have heard the Minnesota Department of Health was very 

instrumental in finding the very source of this outbreak, and we 

were told by them that my mother’s death was key to the whole 

thing. 

Mr. DEAL. Well, I think the reason for this oversight and investigation hearing is to find out how we can best plug the loopholes 

and close the gap so that hopefully we will not see a repeat of this 

kind of situation in the future, and we thank you all for taking the 

time and going to the expense of being here today, and with our 

assurances that I am sure our chairman and other members of this 

committee will follow through to try to make sure we can do the 

best we can from our end to make sure it doesn’t repeat itself. 

Thank you all for being here. I yield back. 

Mr. STUPAK. Ms. Sutton for questions, please. 

Ms. SUTTON. Thank you, Mr. Chairman, and thank you all so 

much for your testimony, for coming here to dispel any notion that 

your loved ones are acceptable collateral damage or some sort of 

statistic as opposed to real people with real families who are suffering because of actions that have been taking place. 

If I may, I would like to show you some new information that the 

subcommittee received and get your response to it. I have a statement from Michelle Pronto, and I believe it is at tab 10. Ms. Pronto 

works for J. Leek Associates, which is one of the private labs PCA 

used to test salmonella. She manages the microbiology lab there. 

The subcommittee spoke with Ms. Pronto and she agreed to provide 

a written statement, which I ask to be placed into the record. 

Mr. STUPAK. Without objection. 

[The information was unavailable at the time of printing.] 

Ms. SUTTON. Ms. Pronto explains in her statement that in October of last year her lab found salmonella in PCA’s peanut products. 

She reported this positive finding to Sam Lightsey, who is the 

plant manager, as we know, in Georgia, and this is how she described their conversation. She stated, ‘‘When I called Mr. Lightsey 

in early October 2008 to give the serology reports that JLA had obtained from Deibel Lab for the confirmed salmonella, he paused 

and said uh-oh or something to that effect and then told me he had 

released the product for shipping. When I asked if he could get it 

back, he said it was on a truck heading to Utah.’’ Now, you guys 

saw that earlier, and let me ask you, any of you, is there anything 

you would like to say in response when you hear this statement 

45 

from the plant manager and that he shipped the product without 

even waiting to get the results of the salmonella test? 

Mr. ALMER. I would like to add, I know that trucks can be 

stopped, doors can be opened, product can be taken out, or the 

truck can be just turned right around. It costs more money, sure, 

but it is easy to do. 

Ms. SUTTON. Anybody else? 

Mr. HURLEY. I would concur. That is absolutely ludicrous. 

Ms. SUTTON. And let me share something else that Ms. Pronto 

had to say. She said, ‘‘During a phone conversation in August 2008, 

Sammy Lightsey of PCA informed me that the Albany, Georgia, 

JLA lab was reporting higher aerobic plate counts—those are APC 

results—and higher coliform results than another lab he apparently used.’’ Then she said this: ‘‘I received an e-mail on 9/10/08‘‘— 

September 10 of 2008—‘‘from JLA employee Stephanie Fletcher 

stating that she was told by QC manager’’—quality control manager—‘‘of PCA that PCA was no longer going to send us samples.’’ 

Finally, she said this: ‘‘I called Mr. Lightsey to follow up on the recent discussion regarding the confirmed positive and he confirmed 

that because of the high coliform results, they were going to send 

samples to a different lab.’’ So this lab official certainly seems to 

be saying that when PCA didn’t like the positive test results, it just 

took its business elsewhere. 

So what is your opinion, and I could guess but I don’t think anyone could say it better than you. What is your opinion of a business 

that engages in activity like this? 

Mr. TOUSIGNANT. I think unfortunately that is an example of 

why we can’t trust self-checking or self-regulation, and I think this 

is an example of why our food supply is not safe. 

Mr. HURLEY. You can’t have lab shopping. You can’t have lab 

shopping going on to find your best results. 

Mr. ALMER. It is just a complete conflict of interest. They are the 

ones who do not benefit by the negative results or positive results, 

whatever they may be. They can’t shop around. 

Ms. SUTTON. Again, I thank you very much for your testimony 

and I am so very sorry for your loss. 

Mr. STUPAK. Following up that last question, if I may, with your 

30 seconds, do you think any lab results from any food producer 

should automatically be sent not only to the producer of that food 

but also to the FDA simultaneously? Any objection to that? 

Mr. HURLEY. No objection, and I actually would have just been 

under the assumption that that is how the process already was. 

Mr. STUPAK. That is not the way it goes. It is part of our legislation. Thank you. 

Mr. Gingrey for questions, please, 5 minutes. 

Mr. GINGREY. Mr. Chairman, thank you, and I have already expressed my condolences to the families and I will repeat that now. 

I know this is a painful experience for all the family members as 

we can see in your faces as you give your testimony. 

I guess the main question that I want to ask you because we will 

have the two subsequent panels, hopefully the second panel will respond to our questions but it is likely, as I said in my opening 

statement, that they will not, but of course, the third panel is a 

very important panel, so I guess my question to each of you is, 

46 

what would you want us to ask them? And when I say ‘‘them’’ I 

am talking about the FDA, I am talking about the CDC, I am talking about USDA, United States Department of Agriculture, and I 

am talking about the department of agriculture in the respective 

States, all 50 have one, and the health departments. And so if you 

could maybe tell me ahead of time what to ask, I will be glad to 

do that when we have that opportunity. 

Mr. ALMER. I would like to respond and ask them why anyone 

would not want to have mandatory recalls. Why do we leave it up 

to the companies to decide when they are going to recall their product? That is an important part. I guess that would be my main 

question. 

Mr. TOUSIGNANT. I am not sure that you are asking the question 

maybe down this line but the question that I have is, why does the 

FDA not already have this authority? Why do they not have the 

ability to recall these items themselves? And secondly is a budgetary issue. Why are there inspectors and number of inspections 

continuing to decline? Who is in charge of the budget? Because if 

you think about people’s main concern, it is safety of food foremost. 

We have to be able to eat. This is just as important as the economy 

is right now. 

Mr. HURLEY. No comment. 

Mr. GINGREY. Well, I thank you gentlemen, and again, I think 

that we on the committee are very appreciative of you coming and 

testifying as painful as it is. I don’t know if you are aware but on 

this committee, on both sides of the aisle, we probably have three 

M.D.’s, we have a registered nurse, we have a clinical psychologist, 

and we have some experts that have been on the committee for a 

long time, the chairman and ranking member, in regard to these 

healthcare issues. So it is something that certainly has got our attention and obviously we plan to do everything we can to try to 

close that weak link in the chain because, as I said, it is only as 

strong as the weakest link and obviously there is a problem, and 

we thank you so much for being here. 

Mr. WALDEN. Would the gentleman yield? 

Mr. GINGREY. I will be glad to the yield to the ranking member. 

Mr. WALDEN. I think it is important to point out that it is already against the Food, Drug and Cosmetic Act law to knowingly 

ship product that tests positive. That is the amazing thing here. 

Out of everything we have, it would appear they knew it was positive. If you get a positive hit on a salmonella test, you are supposed 

to destroy the product. They may test again to figure out in their 

process where they are having this contamination. That is a different deal. But you are not supposed to ship it out for consumption, and that is what is outrageous here. So that piece is already 

in the law. Obviously the inspection piece and some of these other 

things need to be dealt with, but it is just stunning. 

I yield back. 

Mr. GINGREY. Mr. Chairman, if I have any remaining time, I 

yield back. 

Mr. STUPAK. The chair will use 45 seconds of your remaining 

time. Even subpoena power, I have been trying to get the FDA to 

have subpoena power for 12 years. They keep denying us saying 

47 

they don’t need it, a great example where you need subpoena 

power. 

Ms. DeGette. 

Ms. DEGETTE. [Presiding] Thank you. Well, oK, let us talk about 

subpoena power. Let us talk about the criminal laws. But these 

companies don’t even have to produce their records to the FDA if 

they have these tests for salmonella, and in the previous peanut 

contamination hearing we had with ConAgra, what happened was, 

they had—it wasn’t as blatantly criminal as this case, but what 

happened in that case was, they had water dripping down and they 

had all kinds of records that showed this, and they had the FDA 

inspectors come to the factory but the company made this decision 

not to produce the records because the records showed that there 

was a problem, and so while it is true that it is criminal activity 

and while it is also true that the FDA could use subpoena authority, it would be pretty simple for Congress to pass a law, and in 

fact, I think it is in Mr. Dingell’s bill, to say that it is also a requirement that they produce this information when they have a 

test that shows negative, that they produce it to the FDA and put 

some criminal penalties in place, and I am sure all of you gentlemen would agree with that too. 

I don’t really have any questions. I just sit here and I feel sick 

at heart when I hear you talk about your families, and Mr. Hurley, 

when I see your little kids, you know, I have two girls myself, so 

I feel sickened hearing about your parents, and what makes me so 

sick, as I said in my opening statement is, I have been sitting here 

for 12 years listening to this. So I guess what I will say is, I want 

to echo what all of you said. It shouldn’t be that hard for the most 

sophisticated country in the world to put a system in place that requires them to provide the documents when they see a problem, 

that gives the FDA mandatory recall authority, which by the way 

would act, I think, to light a fire under these companies if they 

knew that there was mandatory recall authority and they couldn’t 

mess around. And then as I mentioned in my opening statement, 

traceability so that what happened in Oregon could happen in all 

the States where if you had mechanisms in place that were interoperable, then if you found salmonella in a little kid in Oregon, you 

could rapidly work throughout the United States to figure out the 

source of that salmonella and to recall all those food products. And 

if that happened, I don’t think we would have lost Mr. Almer’s and 

Mr. Tousignant’s parents because we knew about that salmonella 

several months in advance. 

So I will make a commitment to you as someone who has worked 

on this for years along with Mr. Stupak, Mr. Dingell, Mr. Waxman, 

our friends on the other side of the aisle. We are going to do this, 

and I hope we will do it this year because I don’t want to be back 

here in 6 months. Neither do you, Mr. Walden or Mr. Gingrey, any 

of you guys. We have just sat here too long listening to this and 

we can fix it. I have got some legislation. We have comprehensive 

legislation. We need to figure out, should we move this one bill at 

a time. We could do my mandatory-recall bill on the suspension 

calendar next week. Mr. Walden would agree. I will bet you Mr. 

Barton would agree. And we could do comprehensive food safety. 

We have been working on it for a long time. So I will just make 

48 

the commitment to you. We are going to do this and we are going 

to do this in one your loved ones’ memories. I will yield back. 

I recognize Mr. Burgess for 5 minutes. 

Mr. BURGESS. I thank you. And it does seem like deja vu all over 

again to quote a great American. Mr. Walden is exactly correct in 

the way we have dealt with a lot of these things repetitively and 

all the issues with notification, all the issues with recall, all of the 

issues with the failure of the kill step to take the bacteria off the 

exterior of the peanut. Those are all very important. If you have 

a criminal mind at the back of it running the operation, it is just 

hard to know how you deal with that asymmetric threat. We know 

that through multiple hearings, as I referenced in my opening 

statement, we beat on the FDA until it is a wonder there is anything left of them. They need better systems in place. We need to 

fund them better. We recognized that through hearing after hearing after hearing last Congress. We haven’t even done our appropriations from last year yet. Those are due to come up in an omnibus bill in March so they need more money and we know that. We 

have been slow to respond. But still, the baseline, if you have got 

that asymmetric threat of a criminal mind, all of these things are 

very, very difficult to prevent if you have got someone who is willfully ignoring the rules and not just ignoring the rules, purposely 

working against you. 

Dr. Gingrey is correct. You do have three physicians on this subcommittee. You have got a clinical psychologist and a nurse. After 

today’s hearing, we may need the clinical psychologist as well as 

the nurse. I am not sure if the doctors are going to do you any 

good. 

But let me just ask you, being a physician myself, I would like 

to ask each of you the same question generally, and Mr. Deal got 

to it a little bit, but this can be a difficult diagnosis, even though 

the clinical symptoms present themselves, and we are talking 

about salmonella and it seems very obvious to link the clinical 

symptoms with the ultimate diagnosis, but Mr. Almer, in your situation, was the correct diagnosis, did the doctors have that in order 

to timely offer treatment or was this something that was established after the fact? 

Mr. ALMER. We actually though she had died from pneumonia, 

and we found out 2 weeks later that that wasn’t even on the death 

certificate, and we were given notice by the department of health 

of the salmonella positive test. That was our first notice of it. 

Mr. BURGESS. And there is some time lag in normal clinical circumstances between submitting a sample and getting a test result 

back, whether it is positive or negative. So is that in fact what occurred during that time interval or was this something in fact that 

was discovered completely after the fact? 

Mr. ALMER. From what I am told, somebody was doing their due 

diligence at the facility and they noticed they had some patients 

with diarrhea and sent the stool samples for testing and my mother’s was one of those. 

Mr. BURGESS. So there were actually more people in the facility 

who were affected? 

49 

Mr. ALMER. There were actually—my sister lives up in the 

Brainerd community where three of the people have died. There actually are two others that may also die of salmonella at this time. 

Mr. BURGESS. Just for my curiosity, were any diagnoses made in 

time to offer treatment? Salmonella is treatable. Oftentimes the 

other underlying conditions can make it impossible but the organism itself is one that we can generally get if we have got the 

knowledge. 

Mr. ALMER. There was some treatment, possible sepsis, blood infection, which is common, I guess, with salmonella, but I don’t 

think any of us knew or the facility knew that my mother had salmonella at that time, so she was already gone before anyone knew. 

Mr. BURGESS. So to the best of your knowledge, no one received 

lab results in a timely fashion that would have allowed treatment 

to stop the disease? 

Mr. ALMER. No, to my knowledge, no. 

Mr. BURGESS. Yes, sir, and in your case with your dad? 

Mr. TOUSIGNANT. I am sorry? 

Mr. BURGESS. I am going to mess up your name anyway but I 

can’t see your name plate. Tousignant? 

Mr. TOUSIGNANT. Mr. Tousignant, yes. 

Mr. BURGESS. Yes, sir. OK. I am sorry. In your situation, was the 

diagnosis established before your dad died? 

Mr. TOUSIGNANT. To the best of my knowledge, no. I believe it 

was, like I mentioned earlier, a few days to a week later. 

Mr. BURGESS. And again, very, very difficult for the caregivers 

involved because they are doing their best, and in your dad’s situation, a bloodborne infection which obviously would be a good deal 

more aggressive. 

And then Mr. Hurley in your situation, the epidemiologist came 

to the house, but prior to that level of involvement, did your son’s 

caregivers have an idea, did your son’s physicians have an idea, 

that his symptoms clinically might tip off the diagnosis of salmonella? 

Mr. HURLEY. Nothing was mentioned to us in the beginning, and 

actually the samples were given on a Wednesday. On Friday the 

pediatric nurse called and said so far things look good, and then 

it was the next day on Saturday or Sunday that the doctor called 

from home to let us know. 

Mr. BURGESS. And then it was that result that led the epidemiologist to come to your home to collect samples? 

Mr. HURLEY. Correct. First it went to the county. A couple days 

later I got a call from the county health, and then a couple days 

later got a call from the state epidemiology office, answered some 

questions over the phone because then things were really starting 

to move along nationally in terms of PCA, and so then when he 

found out that even while he was sick that he was eating the peanut butter crackers, he said can I come over in a couple of hours. 

Mr. BURGESS. But of course, your son was under active care from 

a pediatrician or infectious disease specialist during the course of 

his illness? 

Mr. HURLEY. No. I mean, they told us what the illness was. Basically we just treated for—I mean, just made sure he had plenty of 

fluids and—— 

50 

Mr. BURGESS. So it was symptomatic treatment? 

Mr. HURLEY. Right, symptomatic treatment, but no, he was not 

in a hospital. 

Mr. BURGESS. Well, again, this underscores it. It is a difficult diagnosis in a clinical setting and then obviously made more much 

difficult by the criminal minds behind this enterprise. So again, 

just like every other member of the committee, our condolences on 

your loss and thank you for spending so much time with us this 

morning. 

I yield back, Mr. Chairman. 

Mr. STUPAK. Ms. Schakowsky for questions, please. 

Ms. SCHAKOWSKY. It is not so much a question, unless you want 

to respond to it, but I do want to be sure and get on the record, 

and I am wondering, is Mr. Parnell here yet? He is to be on the 

next panel, I guess. There is on tab 4 a couple of e-mails that I just 

can’t get over. On June 6, 2008, a PCA employee sent an e-mail 

to Steward Parnell alerting him that their product may have salmonella. If you look at that, you see it says ‘‘lot number put on 

hold,’’ exclamation points, ‘‘I just spoke with Stephanie, with JLA,’’ 

the private laboratory. ‘‘This lot is presumptive salmonella,’’ in 

caps, and a total of 15 exclamation points in these two sentences 

alone. Now, to any normal person, this would be a red flag and the 

alarms would go off and you would realize this is serious. I am sure 

everyone would agree with that. 

So here is the e-mail that Mr. Parnell sent in response. Later in 

the day he wrote, ‘‘I go through this about once a week. I will hold 

my breath again.’’ So how is anyone to react to the incredible disregard of this urgent e-mail? It is just absolutely beyond me. I don’t 

know if any of you can put this into words, and certainly we would 

welcome your words on the record. Mr. Tousignant, did you want 

to—— 

Mr. TOUSIGNANT. When this first happened, I think for a couple 

of my brothers and sisters and I, we wanted to believe that this 

somehow was really just an accident, that something happened 

with one of the companies, that somehow this got into the food. 

And as we have gone along in this process of discovery and learning more information as each day goes on, it just baffles me and 

I know it probably baffles every single one of us up here today and 

our families and the others in the country, that this is affected, 

that any one person can make a decision like this so consistently 

and so blatant. 

Ms. SCHAKOWSKY. I also want to say that I understand if you feel 

angry at us as well because as Congresswoman DeGette said, we 

have been here before, and again, as others have, I just want to 

make a commitment that we are definitely going to create the systems, act quickly so that hopefully we put in place the assurances 

that you are the last panel of people suffering from this that have 

to come before us. Thank you. 

Mr. STUPAK. Thank you, Ms. Schakowsky. 

Let me thank this panel again. I think that concludes 

everybody’s questions. So Mr. Hurley, your family asked when we 

were going to let you go. You are free to go if you want or stay for 

the rest of this hearing, you can, Mr. Tousignant and Mr. Almer, 

if you would like to, you can, but thank you for being here and 

51 

thank you for putting a face on the tragedy that families are feeling across this country. Thank you very much for your testimony. 

Once the clerk clears that table, we will start with our second 

panel of witnesses. Our second panel of witnesses will come forward. On our second panel, we have Mr. Stewart Parnell, who is 

president of Peanut Corporation of America, and Mr. Sammy 

Lightsey, plant manager of that Peanut Corporation of America’s 

Blakely, Georgia, facility. 

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

oath. Please be advised, gentlemen, that witnesses have the right 

under the rules of the House to be advised by counsel during their 

testimony. Do you wish to be represented or advised by counsel, 

Mr. Lightsey? 

Mr. LIGHTSEY. No. 

Mr. STUPAK. Mr. Parnell? 

Mr. PARNELL. Yes, sir. 

Mr. STUPAK. I would ask you to state the name of your counsel 

who will be advising you. Counsel cannot testify but can advise 

you, and before you answer a question if you want to consult with 

them before you answer it, you are allowed to under the rules of 

the House. So who would your counsel be, sir? 

Mr. PARNELL. Bill O’Reilly. 

Mr. STUPAK. OK, and Mr. O’Reilly, you are right here then, 

right? OK. Mr. Lightsey? 

Mr. LIGHTSEY. I am sorry. I misunderstood the question. 

Mr. STUPAK. Hit your mic, right there, a little button there. Is 

Mr. O’Reilly going to be your counsel too? 

Mr. LIGHTSEY. No, Jim Parkman. 

Mr. STUPAK. Jim? 

Mr. LIGHTSEY. Parkman. 

Mr. STUPAK. Parkman. OK. Mr. Parkman, raise your hand just 

so we know who you are. OK. Very good. The sample applies to 

you. If you want before you any questions you want to consult with 

your counsel, you have a right to do so. So I am going to ask you 

both to rise and raise your right hand to take the oath. 

[Witnesses sworn.] 

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

the affirmative. You are now under oath. You will 5 minutes for 

an opening statement or you may submit a longer statement for inclusion in the hearing record. 

TESTIMONY OF STEWART PARNELL, PRESIDENT, PEANUT 

CORPORATION OF AMERICA; AND SAMMY LIGHTSEY, PLANT 

MANAGER, PEANUT CORPORATION OF AMERICA 

Mr. STUPAK. Mr. Lightsey, do you have an opening statement? 

Mr. LIGHTSEY. No, I do not. 

Mr. STUPAK. Mr. Parnell? 

Mr. PARNELL. No, sir. 

Mr. STUPAK. Then we are going to go right to questions, and 

members have 5 minutes for questions, and I will begin. 

Mr. Parnell, I want to ask you about an e-mail you sent to your 

employees at the Peanut Corporation on January 12, 2009, after 

public health officials found salmonella in peanut butter from your 

plant in Georgia. Right in front of you right there is our binder tab. 

52 

It is tab #44, if you care to look at it. In particular, I want to ask 

you about the following statement you made in that e-mail. You 

said, ‘‘We do not believe the salmonella came from our facility. As 

you probably know, we send hourly PB samples to an independent 

lab to test for salmonella during production of peanut butter and 

we have never found any salmonella at all.’’ Mr. Parnell, during its 

investigation FDA found on 12 separate occasions between June 

2007 and September 2008 peanut products produced by PCA and 

tested by private labs were found to be contaminated with salmonella. On six of these occasions the FDA found that you had already shipped the product and that you conducted no subsequent 

testing. So your statement that you ‘‘never found any salmonella at 

all’’ does not appear to be true. So here is my question then, and 

I remind you, you are under oath: Mr. Parnell, did you or any officials at the Peanut Corporation of America ever place food products 

into the interstate commerce that you knew to be contaminated 

with salmonella? 

Mr. PARNELL. Mr. Chairman and members of the committee, on 

the advice of my counsel, I respectfully decline to answer questions 

based on the protection afforded me under the United States Constitution. 

Mr. STUPAK. Mr. Parnell, let me ask you this. In the last panel, 

and you heard the last panel testify, did you not? 

Mr. PARNELL. Mr. Chairman and members of the committee, on 

the advice of my counsel, I respectfully decline to answer your 

question based on the protection afforded me under the United 

States Constitution. 

Mr. STUPAK. I just asked you if you heard the other panel. 

Mr. PARNELL. Mr. Chairman and members of the committee, on 

the advice of my counsel, I respectfully decline to answer your 

question based on the protection afforded me under the United 

States Constitution. 

Mr. STUPAK. OK. Well, let me ask you this question, Mr. Parnell. 

The earlier panel, we talked a little bit about money and some of 

the e-mails and statements attributed to you about cost of business, how not moving product was hurting you, hurting your business, and that actually you deal with salmonella, again from the 

e-mails, once a week. So the food poisoning of people, is that just 

a cost of doing business for your company? 

Mr. PARNELL. Mr. Chairman and members of the committee, on 

the advice of my counsel, I respectfully decline to answer your 

question based on the protection afforded me under the United 

States Constitution. 

Mr. STUPAK. Mr. Walden, I believe you had a question you had 

alluded to earlier. Would you like to ask that question? 

Mr. WALDEN. I would, Mr. Chairman. 

Mr. Parnell, Mr. Lightsey, let me just cut to the chase then. In 

this container are products that have your ingredients in them, 

some of which were on the recall list, some of which are probably 

contaminated. It seems like from what we read you are willing to 

send out that peanut base with these ingredients, and I just wonder, would either of you be willing to take the lid off and eat any 

of these products now like the people on the panel ahead of you, 

their relatives, their loved ones did? 

53 

Mr. PARNELL. Mr. Chairman and members of the committee, on 

the advice of my counsel, I respectfully decline to answer your 

question based on the protection afforded me under the United 

States Constitution. 

Mr. WALDEN. Mr. Lightsey? 

Mr. LIGHTSEY. At this time on advice of counsel, I exercise my 

rights under the Fifth Amendment of the Constitution. 

Mr. STUPAK. Mr. Parnell, is it your intent to refuse to answer all 

of our questions today based on your right against self-incrimination afforded to you under the Fifth Amendment of the Constitution? 

Mr. PARNELL. Yes. 

Mr. STUPAK. Mr. Lightsey, is it your intention to refuse to answer all our questions today based on the right against self-incrimination afforded to you under the Fifth Amendment of the Constitution? 

Mr. LIGHTSEY. Yes. 

Mr. STUPAK. All right. Then I have no choice but that both of you 

are dismissed at this time. You are subject to the right of the subcommittee to recall you at a later time and date if necessary. 

I would now like to call our third panel of witnesses to come forward. On our third panel we have Dr. Stephen Sundlof, who is the 

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

Food and Drug Administration; Mr. Oscar Garrison, who is the assistant commissioner of the Consumer Protection Division at the 

Georgia Department of Agriculture; Ms. Darlene Cowart, who is 

the president of J. Leek Associates Incorporated, JLA, and Mr. 

Charles Deibel, who is president of Deibel Laboratories. 

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

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

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

of you wish to be advised by counsel during your testimony? Ms. 

Cowart? 

Ms. COWART. Yes, Mr. Chairman, I have counsel present today, 

and I do wish to be represented. 

Mr. STUPAK. Counsel’s name is? 

Ms. COWART. Mr. Evans Plowden and his associates. 

Mr. STUPAK. OK. If you want to consult with them before you answer a question, please do. 

Ms. COWART. Thank you. 

Mr. STUPAK. Mr. Deibel? 

Mr. DEIBEL. Yes, sir, I have counsel present but they are sitting 

in back of me. 

Mr. STUPAK. Just identify their name for the record. 

Mr. DEIBEL. Charles Deibel. 

Mr. STUPAK. Mr. Deibel, your lawyer’s name. You stated your 

name. 

Mr. DEIBEL. Richard Chapman. 

Mr. STUPAK. Mr. Garrison, do you wish to have counsel present? 

Mr. GARRISON. Yes, sir, I am being represented by Mr. Ted Hester of King and Spaulding at the request of our Georgia Attorney 

General, Thurbert Baker. 

Mr. STUPAK. Very good. Mr. Chappell? 

Mr. CHAPPELL. Mr. Chairman, no, sir. 

54 

Mr. STUPAK. Dr. Sundlof? 

Dr. SUNDLOF. No, sir, Mr. Chairman. 

Mr. STUPAK. OK. As I said, it is the policy to take all testimony 

under oath. I am going to ask you now to rise and raise your right 

hand to take the oath. 

[Witnesses sworn.] 

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

the affirmative. You are now under oath. We will begin with opening statements for 5 minutes. If you wish to submit a longer statement for inclusion in the record, that will be allowed. Dr. Sundlof, 

let us start with you, please, sir. 

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

OF THE CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED 

BY MICHAEL CHAPPELL, ACTING ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION; OSCAR GARRISON, ASSISTANT COMMISSIONER, CONSUMER PROTECTION DIVISION, GEORGIA DEPARTMENT OF AGRICULTURE; DARLENE COWART, PRESIDENT, J. LEEK ASSOCIATES, INC.; AND CHARLES DEIBEL, 

PRESIDENT, DEIBEL LABORATORIES 

TESTIMONY OF STEPHEN SUNDLOF 

Dr. SUNDLOF. Thank you, Mr. Chairman and members of the 

committee. I am Dr. Stephen Sundlof, 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. I am accompanied today by Mr. Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. 

FDA appreciates the opportunity to discuss our ongoing investigation of the foodborne illness outbreak associated with salmonella 

typhimurium, which has been found in peanut products produced 

by the Peanut Corporation of America, or PCA. 

Let me begin by expressing my personal and the agency’s concern for people harmed in this outbreak of foodborne illness. FDA 

can and will learn from this outbreak what we can do to better assure the safety of our food supply moving forward. And it is important to note that the manufacturers play a critical role in ensuring 

the safety of the foods that they introduce into commerce. Strong 

food safety programs begin with a commitment and the strong 

oversight of the managers and the promotion of strong food safety 

culture throughout the company. 

In the typical traceback process employed by FDA and our partners at the Centers for Disease Control and Prevention, CDC notifies FDA when it identifies the possible foods associated with 

foodborne illness through its epidemiological investigation. At that 

point the FDA starts its investigation to identify the source of contamination. In the current case, FDA started its tracing process before CDC notified us of a strong epidemiological link to both help 

inform the epidemiological study and to shorten the time required 

to remove potentially contaminated foods from the market. Since 

early December of 2008, FDA has collaborated with the CDC, U.S. 

Department of Agriculture and state public health departments to 

55 

investigate the multi-State outbreak of human infections due to 

salmonella typhimurium. 

Peanut butter was first identified as a possible source in mid-December, and on January 7 and 8, based on preliminary epidemiological data, the FDA decided to investigate institutional food 

sources of peanut butter rather than wait for more-conclusive data. 

On January 7, FDA made its initial contact with the King Nut 

Company, which distributes peanut butter manufactured by PCA 

to institutional facilities, food service industries and private label 

companies. Two days later on January 9, FDA initiated our inspection of the PCA manufacturing plant in Blakely, Georgia. As part 

of its epidemiological investigation, the Minnesota Department of 

Health tested an open 5-pound container of King Nut peanut butter obtained at a nursing home where three patients were sickened 

by the outbreak strain of salmonella typhimurium. By January 10, 

Minnesota health officials had found that peanut butter contained 

the same strain of salmonella typhimurium. However, because it 

was an open container which could have been contaminated by 

someone or something else in the environment, these results did 

not confirm the Blakely plant as the source. 

So FDA expanded the testing of unopened containers of the same 

brain of peanut butter, and on January 19, the Connecticut Department of Health tested an unopened container of King Nut peanut 

butter and found that it contained the same strain of salmonella 

typhimurium associated with the illness 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 Blakely processing plant. 

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

PCA’s Blakely plant on January 9. We completed our inspection on 

January 27. FDA’s environmental sampling at the plant found two 

salmonella strains, neither of which was associated with the outbreak. We are confident, however, that based on the investigations 

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

of contamination related to the salmonella typhimurium outbreak. 

Further, FDA’s review of the testing records revealed 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. Expanded recalls followed on January 

28 and on January 28 the firm voluntarily recalled all peanut products processed in its Blakely facility since January 1, 2007, and 

these included dry and oil-roasted peanuts, granulated peanuts, 

peanut meal, peanut butter and peanut paste. Many companies 

that received the peanuts and peanut products manufactured by 

PCA’s Blakely facility have in turn conducted their own voluntary 

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

peanuts and peanut products to identify affected products and facilitate their removal from the market. FDA initiated inspections 

at the direct consignees of PCA and King Nut and continues to follow the distribution points of the products. FDA has established a 

web page to provide constantly updated information on the contamination and recall. It includes a searchable databases to assist 

56 

consumers in quickly identifying recalled products, and we encourage consumers to check this Web site frequently. 

FDA is reviewing with Health and Human Services our prior legislative requests to strengthen the agency’s ability to protect Americans from foodborne illness to determine whether those requests 

should be updated in light of our experience with this outbreak. At 

this time we want to highlight the need for enhanced authorities 

in several areas. Number one, authority for FDA to issue preventive controls for high-risk foods; two, authority for enhanced access 

to food records during routine inspections; three, the authority for 

FDA to require food facilities to renew their registrations every 2 

years and for FDA to modify the registration categories. In addition, we note that mandatory recall authority would be a useful 

tool that in some circumstances could result in faster removal of 

implicated products from commerce. 

In closing, Mr. Chairman, let me assure you that the FDA is 

working hard to ensure the safety of the food supply in collaboration with our federal, State, local and international food safety 

partners. 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 and food 

safety is a priority of the new Administration. Please be aware that 

FDA is actively conducting both criminal and regulatory investigations related to this 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. It is also premature for FDA to draw conclusions about 

our preliminary observations or how the 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. 

[The prepared statement of Dr. Sundlof follows:] 

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Mr. STUPAK. Thank you. 

Mr. Chappell? 

Mr. CHAPPELL. I don’t have an opening statement. 

Mr. STUPAK. OK. Mr. Garrison, opening statement, please, sir, 5 

minutes. If you have a longer statement, we will submit it to the 

record. 

TESTIMONY OF OSCAR GARRISON 

Mr. GARRISON. Chairmen Waxman, Stupak, Ranking Members 

Barton and Walden, and distinguished members of the subcommittee, I would like to thank you for the opportunity to offer 

this testimony today. I am here on behalf of Georgia’s Commissioner of Agriculture, Tommy Irvin. I am Oscar Garrison, the assistant commissioner responsible for Georgia Department of Agriculture’s Consumer Protection Division. I have been directly involved with food safety at various levels for more than 15 years. 

I want to express my sympathy to the victims of the salmonella 

outbreak that were here today and also to the victims of foodborne 

illness in this country. 

The Georgia Department of Agriculture takes its commitment to 

food safety very seriously. We are more concerned about food safety 

and food being sold and processed in Georgia than anyone. To more 

effectively carry out our mission, the Department is working with 

our State legislature on an amendment to the Georgia Food Act 

that would require regular testing by the food manufacturers in 

Georgia. This legislation would require processing plants to 

promptly report to the Department the presence of any suspected 

contamination that would render food injurious to health or otherwise unfit for consumption. We encourage this committee to consider federal legislation that would require similar testing and reporting nationwide. 

We would like to have additional resources that would permit us 

to perform more inspections more frequently and comprehensively 

along with product testing, but with tightening budgets, FDA, 

Georgia and other States are stretching their resources about as effectively as we are able to. The Department has requested and our 

governor has recommended $24 million to help fund a new laboratory to be located in south Georgia that would increase the product 

testing that our Department is currently capable of performing. 

Currently, we can test about 4,500 food samples per year in our 

State laboratories. The Georgia Department of Agriculture is required through the Georgia Food Act to license and inspect food 

sales establishments and processing plants. We inspect approximately 16,000 facilities ranging from processing plants to food storage warehouses to retail grocery stores. These inspections are conducted by a field force of approximately 60 inspectors. 

For many years the Department of Agriculture, like agencies in 

other States, has had a contractual relationship with the Food and 

Drug Administration that requires us to conduct inspections at various food-processing plants in Georgia that ship products into interstate commerce. Including the two inspections we conducted for 

FDA, our Department conducted a total of nine inspections at the 

plant between 2006 and 2008. During these inspections, our inspecVerDate Nov 24 2008 15:13 Feb 08, 2012 Jkt 037690 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS 111\2009\111-2 CHRIS
71 

tors did not see any conditions that would raise a red flag indicating an imminent health hazard. 

An inspection is simply a snapshot in time. An inspector can only 

see what is there at that particular time that they are conducting 

the inspection. The Department utilizes all the resources available 

to us to verify that food processors are operating responsibly. However, it is important to recognize that if processors do not act responsibly and most certainly if they engage in criminal activity designed to avoid detection, the most rigorous and regular inspections 

would not readily detect a problem. We do not have all the facts, 

but once the Peanut Corporation of America had test results disclosing the presence of salmonella, it was unconscionable for that 

company to ship the product, fail to recall the product or fail to notify us or FDA. 

In closing, let me thank you for joining with us in an effort to 

improve the safety of this country’s food supply. This tragic situation must serve as a wakeup call leading to reforms in the United 

States food safety network and through additional funding that will 

permit food safety agencies at the federal, State and local levels to 

more effectively perform their jobs. Thank you. 

[The prepared statement of Mr. Garrison follows:] 

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Mr. STUPAK. Thank you, Mr. Garrison. 

Ms. Cowart, your opening statement, please, for 5 minutes. If 

you have a longer statement, we will insert it in the record. 

Ms. COWART. Thank you. 

Mr. STUPAK. Thank you. 

TESTIMONY OF DARLENE COWART 

Ms. COWART. Mr. Chairman, my name is Darlene Cowart, and 

you have my biographical information, I believe, in the record. My 

education has been in biology and food science, and I have worked 

in the agricultural commodity and food-related quality control area 

since completing my education. I am currently president of JLA 

USA. Our company is one of several under the umbrella of JLA 

Global, which has facilities in the United States and abroad. JLA 

USA has testing facilities in seven locations in the United States. 

While the majority of our work is related to the peanut industry, 

we also provide services and testing to the almond industry and to 

some degree other food businesses. JLA USA maintains microbiology laboratories in Albany, Georgia, and Edenton, North Carolina. We provide a broad range of testing services to the agricultural commodity and food business. I understand the committee’s 

concerns today relate to the recent salmonella outbreak and therefore involve our microbiology testing. 

Mr. Chairman, when we test for salmonella, we receive from the 

customer samples of the product to be tested together with the notification of the test that the customer wants us to perform. Specifically, we receive a request for analysis which details the battery of 

tests desired by the customer and includes the customer’s description of the product to be tested, and I believe you have copies of 

these also in the record. I have also furnished the committee staff 

a detailed description of the method we use to test for salmonella, 

and I will simply summarize that here. 

First we pull a representative sample from the customer’s containers to get a composite sample of 375 grams. That composite 

sample is then put into a sterile bag with other substances and incubated. We remove some of the mixture into the test tubes and 

for other procedures and eventually we put the resulting substance 

into what is called a VIDAS instrument. This machine’s computer 

will automatically give us the result either positive or negative for 

salmonella. If the result is not negative from the instrument, the 

negative certificate of analysis is sent to the customer. If the result 

is positive, it is what we call in our laboratory a presumptive positive, which must be confirmed, because at this point several organisms can look like salmonella but are not. However, since the test 

necessary to confirm the presumptive positive can take up to 5 

days, we notify the customer of the presumptive positive by e-mail 

and a telephone call. The confirmation process is quite technical 

and is also described in the paper that we furnished the committee 

staff. If after the confirmation we find that salmonella is ruled out, 

we prepare a negative certificate of analysis for immediate release 

to the customer. If we do confirm that the presumptive positive is 

salmonella, then we prepare and issue a positive certificate of analysis and again we notify the customer via a telephone call and an 

79 

e-mail alert. Mr. Chairman, all these procedures confirm to the appropriate FDA and accepted laboratory standards. 

From January 1, 2007, through September of 2008, we tested approximately 1,000 samples of product from Peanut Corporation of 

America. Of these in 2007, six samples were confirmed positive for 

salmonella, and all the rest were negative. In 2008 we issued a 

total of four confirmed salmonella positive certificate of analysis. I 

wish to emphasize, Mr. Chairman, that we at JLA do not take the 

samples from the product nor do we have knowledge of the sampling procedure used by PCA for the samples we receive. With respect to the PCA samples on each occasion that JLA received samples, the product samples would have been sent by mail to a JLA 

laboratory together with this request for analysis. The information 

provided on the request for analysis is the only information about 

the sample that JLA receives. Following a confirmed salmonella 

positive issued to PCA in August of 2008, PCA discontinued sending product samples to JLA with one exception. We did receive a 

few test samples under the name PP Sales, and it is my understanding that this name is an internal designation within PCA and 

possibly refers to a different product line. JLA did test and obtain 

a confirmed salmonella positive on a PP Sales sample sent to JLA 

in late September 2008. A positive COA was issued to PCA in early 

October 2008. In every instance when we found presumptive 

positives or confirmed positives, we reported the results to PCA by 

e-mail and telephone as I described earlier. 

Salmonella can occur in raw agricultural commodities and the accepted procedure for killing salmonella in raw agricultural products 

is to heat the product to a necessary temperature for the appropriate period of time, and that procedure is commonly referred to 

as the kill step. It is possible for salmonella to be reintroduced into 

a product after the kill step. This can occur if the product comes 

in contact with contaminated raw ingredients, equipment or personnel. Therefore, it is extremely important that all food manufacturing facilities maintain proper procedures and processes to ensure that recontamination does not occur. Salmonella in processed 

foods is preventable and the application of an appropriate kill step 

combined with good manufacturing processes that eliminate the 

possibility of recontamination should result in a salmonella-free 

product. Microbiological testing for salmonella and other pathogens 

is an important evaluative tool that manufacturers can and should 

employ to ensure that their manufacturing processes are safe. 

Mr. Chairman, we are cooperating fully with the committee and 

your staff and JLA pledges to continue working with the committee 

to make certain the food supply is safe for all consumers. Thank 

you, Mr. Chairman. 

[The prepared statement of Ms. Cowart follows:] 

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Mr. STUPAK. Thank you. 

Mr. Deibel, your opening statement, please. 

TESTIMONY OF CHARLES DEIBEL 

Mr. DEIBEL. Good morning, Chairman Stupak and members of 

the subcommittee. I would like to thank you for giving me this opportunity to speak with you today. My name is Charles Deibel and 

I am the president of Deibel Laboratories, a firm that specializes 

in microtesting food and personal care products and food safety 

consulting. We have 10 labs in North America with our headquarters in Illinois. For more than 40 years Deibel Labs has provided scientific consulting services to food manufacturers around 

the country. My father, who remains active in the company today, 

started Deibel Labs when he was the dean of the University of 

Wisconsin’s bacteriology program in the late 1960s. He is widely 

recognized as one of the most knowledgeable scientists in the food 

industry, pioneering test methods still in use today and helping to 

shape food safety systems in America. In addition to microtesting 

food products and their ingredients, we work with many manufacturers to help evaluate their existing food safety programs, conduct 

risk assessments, perform plant audits and offer training in food 

safety procedures. 

I would like to give you a brief summary of Deibel Lab’s dealings 

with Peanut Corporation of America, or PCA. My company did not 

provide day-to-day testing services for PCA as we did for many of 

our clients. Instead, during 2007 and 2008, PCA’s Plainview, 

Texas, and Blakely, Georgia, facilities sporadically submitted samples containing peanuts to Deibel Labs to test. We have voluntarily 

cooperated with the Centers for Disease Control, the Food and 

Drug Administration and this subcommittee to provide detailed 

records of the tests we performed for PCA’s facilities including 

samples from PCA’s Blakely facility that tested positive for salmonella in late September 2008 and our records of the immediate 

communications of those results to PCA’s Blakely facility personnel. We also provided records detailing the requests that personnel at the Blakely facility made to us to retest existing samples 

and the negative results of those tests. 

Mr. Chairman, may I briefly supplement the written statement 

that is in the record? 

Mr. STUPAK. Without objection, yes. 

Mr. DEIBEL. As you know, the story about PCA’s actions becomes 

clearer almost by the hour. I have learned more in reading the 

FDA’s Web site publications, the results of the investigation recorded, readings in newspapers and in sitting today. I am horrified 

in seeing the projections of the very damning e-mails in the screens 

to our left and right. 

In late January the FDA and CDC requested that our labs provide them with cultures of ingredients we tested, and based on provisions of the 2002 Bioterrorism Act we voluntarily submitted this 

work. In late January counsel for this committee came to us as 

part of the subcommittee’s investigation. We voluntarily and 

promptly provided staff counsel with all relevant documents and 

access to witnesses and myself within minutes of any request. On 

February 5, 2009, we first saw and learned of the willful and gross 

89 

negligence in sanitary manufacturing and Good Manufacturing 

Practices contained in FDA’s amended investigation report. At 

about that same time we received samples from the PCA Texas facility and found them to be positive for salmonella. We promptly 

provided that information to your committee and FDA. 

It is not unusual for Deibel Labs or for other food testing laboratories to find that samples clients submit do test positive for salmonella and other pathogens. What is virtually unheard of is for 

an entity to disregard those results and place potentially contaminated products into the stream of commerce. I commend the subcommittee for examining what can be done to prevent an incident 

like this from happening again. 

As discussions progress on how best to reform our national food 

safety program, I urge you to look at the entire model used today. 

Our current food safety system relies heavily on inspections conducted by the FDA and the State agencies with which it contracts. 

This is a reactive response rather than the comprehensive, systemic process needed to safeguard our food. The FDA should focus 

on quality control systems that minimize the potential for contamination to occur in the first place and develop mitigating strategies 

for correcting a potential issue before it impacts food safety. 

The FDA has a great deal of knowledge and understanding of 

how manufacturers can improve our food safety practices. Our Nation’s small and medium-sized companies in particular could greatly benefit from guidance documents from FDA yet their job is to 

inspect, not to provide guidance and so they don’t. Yet the USDA 

routinely issues guidance documents to the food processors under 

its jurisdiction. FDA staff are reluctant to point manufacturers to 

the information and resources they need or provide direct guidance 

on how an observation can be corrected. As a result, opportunities 

to improve food production practices are missed. Testing, much like 

inspection, is only one piece of an overall food safety policy. It is 

the last chance to catch a problem. 

The larger piece, however, is on the front end, quality control 

systems that minimize the potential for the contamination to occur 

in the first place. Every year millions of pounds of food products 

end up in landfills because of positive test results for harmful organisms. The problem here is not in finding a positive test result. The 

issue we are discussing here is a firm that found a positive, tried 

to contest the compliancy and released the product anyway. The attention to this issue of food safety is important. It is an opportunity 

to build stronger bridges between FDA and the food manufacturers. 

By taking a preventative, systemic approach, we can implement reforms that will go a long way towards ensuring that consumers 

have access to safe and wholesome foods. Thank you. 

[The prepared statement of Mr. Deibel follows:] 

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Mr. STUPAK. Thank you. That concludes the opening statements. 

I ask unanimous consent that Chairman Dingell, his full statement 

be made part of the record. Without objection. 

[The prepared statement of Mr. Dingell follows:] 

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Mr. STUPAK. I will also note for the record that Mr. Inslee was 

here. I guess he is going to be back, and as a member of the full 

committee would be allowed to ask questions of this panel. 

And we have three different parts of this panel, if you will. We 

will probably go more than one round of questions so we will try 

to go 5 minutes and we will come back if we have to. 

Ms. Cowart, let me ask you a couple questions if I may. On tab 

38 is the first tab I sort of see in here in the binder. It is a November 2, 2006, letter to Mr. Parnell of PCA, Peanut Corporation of 

America. In 2006 were you consulting with them as to their plant 

and salmonella? In looking at this, it looks like you were acting 

more as a consultant as opposed to lab testing, right? 

Ms. COWART. At this point I received a phone call, our JLA received a phone call, and they had a problem or they reported a 

problem with some salmonella in some peanut granules and they 

needed someone to do a walk-through of the facility, and so by 

proximity, based in Albany, Georgia, and I have that background, 

I did go through and do a walk-through and tried to help them understand where the salmonella was coming from on that particular 

issue. 

Mr. STUPAK. So in 2006 JLA was not testing, you sort of did a 

walk-through to try to figure out where the salmonella was coming 

from? 

Ms. COWART. Right. I didn’t pull any samples at that point. Our 

company has a microbiology department that does testing, and 

then there is another piece that will help, as you just—— 

Mr. STUPAK. Sure. And in this tab 38, in this letter, you sort of 

indicated three sources, right? It could have come from the organic 

Chinese peanuts? 

Ms. COWART. That was what they told me when I arrived there, 

that that was the source of the granules. 

Mr. STUPAK. OK. Or I think you identified it come have come 

from production because there was some question about not cooking it long enough, high enough temperatures to kill the salmonella, right? 

Ms. COWART. What I asked for was the documents for the time 

and temperature of the roaster, and that could not be provided at 

the time. 

Mr. STUPAK. And then of course there was also in the packaging 

because they were using water in the packaging area and we all 

know water is a great source of salmonella, especially in peanut 

butter, as we know from the 2007 ConAgra outbreak. 

Ms. COWART. Yes, sir, and also if you will note in the letter, it 

also takes about packaging roasted product in a raw zone. 

Mr. STUPAK. Correct. OK. So we had three possibilities there 

identified in your letter there. Let me go next to Exhibit 40, just 

two back. That is dated February 4, 2008. Now, at this point in 

time, because you are talking about a kill study and you are making suggestions as to a kill study, is that correct? 

Ms. COWART. Yes, sir, I believe they contacted our Edenton, 

North Carolina, facility to help them understand a kill step study 

for their roaster, and we were trying to understand how to go about 

doing that. That is not something that we had ever done before as 

98 

a laboratory and so this was a new process for us and so we were 

trying to understand how to do that. 

Mr. STUPAK. OK. So between 2006 and 2008, is it fair you consulted, JLA was a consultant then to the Peanut Corporation of 

America? 

Ms. COWART. No, sir, we were not. These were—this was a moment in time in 2006, and I didn’t have any follow-up with them 

after that. 

Mr. STUPAK. OK. So 2006, and you didn’t have any follow-up 

with them until 2008, until this possible kill study, right? 

Ms. COWART. Correct. They contacted us, and that is how it usually worked with PCA from JLA’s perspective. We are an independent testing laboratory and we do microbiology testing. If they 

have a question, we will try to answer their question. 

Mr. STUPAK. So between 2006 and then again in 2008, in 2006 

you had salmonella. Did you have any indication in 2008 at the 

time this memo was written, which is February 4, that they had 

other occurrences of salmonella at the Blakely plant? 

Ms. COWART. No, sir, I was not aware of them, no, sir. 

Mr. STUPAK. OK. You indicate in here that, again the same document, February 4, on Monday you are using oven at three different 

temperatures, you are going to use these spore strips, which was 

something different. What is the cost of those spore strips? 

Ms. COWART. I am sorry. Could you repeat that question? 

Mr. STUPAK. Sure. The third paragraph from the bottom, it says, 

‘‘Monday I am starting a lab study using oven at three temperatures, 295, 300, 310 with duplicate BI spore strips exposed to the 

heat for varying times,’’ and you listed times. To do that, these 

spore strips, which is to help kill the salmonella spores, correct, if 

there is any in there, if you heat it up? 

Ms. COWART. Yes, sir, this is a lab study and so these spore 

strips, what they were trying to do is not to introduce a pathogen 

but a surrogate, yes, sir. 

Mr. STUPAK. What would it cost to put these spore strips in with 

your production? 

Ms. COWART. I am not sure I know. I don’t know that answer. 

Mr. STUPAK. Let me ask you this. You support then, it has been 

suggested throughout today, that labs, food processors should be 

registered, should be certified, the people doing the testing, and 

that the results should be filed with the FDA on every test? 

Ms. COWART. Yes, sir, I think we agree with that. I mean, having 

heard what we have heard this week and in the papers, I think it 

is the right thing to do. I think we would want to be a part of the 

solution, absolutely, yes, sir. 

Mr. STUPAK. Mr. Deibel, how about yourself? Do you think labs 

that do testing, labs should be certified by the FDA, that people 

doing the testing should be registered or make sure they have 

proper qualifications, and that the results of every test whether it 

is positive or negative be electronically submitted to the FDA? 

Mr. DEIBEL. In regards to laboratory accreditations, I mean certainly laboratories should be using the published methods. They 

should be using good practices in regards to laboratory. We call 

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oratory, mandating that the laboratory would submit those test results to government, I don’t believe that would be a good practice. 

Mr. STUPAK. How do you prevent lab shopping then, as has been 

alleged in this case? 

Mr. DEIBEL. That I don’t know. The overriding concern of this, 

and I am a consumer, my laboratory does a lot of testing for food 

safety, we want to have safe food. The entire industry at large, if 

you look at all the foods that we consume on a daily basis, and I 

am not just talking the foods that we make but the ingredient companies that manufacture ingredients for those, you know, finished 

product manufacturers, it is an enormous industry, and on a dayto-day basis most of us eat safe foods and we don’t have an illness, 

and I think based on the huge amount of food companies that are 

out there, generally, you know, there isn’t—my concern, I guess, in 

reporting those positive results is that you would actually encourage those businesses to test less. There are different types of tests 

that are done all along the manufacturing process. A raw ingredient before you use it, you do process validation work. You test 

your environment. We want to encourage that. We want to encourage companies to find problems if they exist, and again, my overriding concern—— 

Mr. STUPAK. Then how do we ever know then if a company is 

having positive test results if they are not reporting it to anybody 

but themselves? 

Mr. DEIBEL. Every year millions of pounds of products feed landfills so companies find a positive result, destroy product, do not 

ship it—— 

Mr. STUPAK. In theory. In theory they do that, right? Because obviously here they didn’t do it. 

Mr. DEIBEL. Correct. I guess a food company, it is a business, 

and they are not in business to manufacture a product that will get 

somebody sick and they are at their best when they can make safe, 

wholesome products that a consumer will buy, enjoy and buy again. 

If a company manufactures a product where somebody eats it, falls 

ill, they are likely not to be in business. 

Mr. STUPAK. So it is just a cost of doing business then when people get sick? 

Mr. DEIBEL. Most food companies do spend, I would say in my 

experience, a lot of money and a lot of their efforts, their resources 

in making safe and wholesome foods, and we would want to have 

them be able to have the right to test as much as they can, find 

the problem—— 

Mr. STUPAK. Right, but this is our ninth hearing in 2 years. If 

we don’t get on this thing, if we don’t require some kind of reporting, how are we ever going to end this? I mean, we can’t be doing 

this every—let us see, nine times in 2 years, every, what, 2 

months, a new outbreak? 

Mr. DEIBEL. Testing though is just one aspect of the overall food 

safety program. 

Mr. STUPAK. I agree. 

Mr. DEIBEL. And we really need to be focusing more on preventative strategies because even in testing, I mean, we see this with 

PCA. Even when several labs were involved testing, you always 

didn’t find it, even though we knew it was there. 

100 

Mr. STUPAK. Because no one was reporting it. 

Mr. DEIBEL. It became known that it was—— 

Mr. STUPAK. Because nobody was reporting it. I agree with you, 

we should be proactive as opposed to reactive. Right now we are 

reactive. If we had reporting, mandatory, maybe we could be 

proactive. 

With that, I will turn to Mr. Walden for questions. 

Mr. WALDEN. Thank you, Mr. Chairman. 

I guess that a question I want to go to the FDA on. Wouldn’t you 

benefit from knowing the lab results? 

Dr. SUNDLOF. Thank you, Congressman, yes. FDA like any other 

enforcement organization wants all the information we can get. 

Mr. WALDEN. And you don’t get those lab results today, correct? 

Dr. SUNDLOF. That is correct. 

Mr. WALDEN. And would you be overwhelmed with the number 

of lab results you would get? 

Dr. SUNDLOF. It is hard to say, I mean, but certainly having that 

information available would be very helpful. 

Mr. WALDEN. Only if it is in a form that could be readily 

accessed and utilized. It seems to me like there ought to be in the 

modern era of computers a way where those lab results could go 

in and then flag if there is a facility that repeatedly tests positive 

for salmonella. It would help you identify where you need to go inspect, wouldn’t it? 

Dr. SUNDLOF. I believe that is right. 

Mr. WALDEN. Now, let me go back to Mr. Deibel. I am troubled 

with this notion that those lab results shouldn’t be shared with the 

FDA or the Georgia Department of Agriculture or whomever, and 

I don’t disagree that I think they should be inspected. I think they 

should seek out, I think as a small businessperson I had nothing 

to do with food, but it seems to me in their best self-interest to 

make sure their product line works and is sanitary. In theory, most 

don’t want to make somebody sick. So what is the harm in sharing 

those positive results with the regulators so that they are on notice 

there may be a problem here? 

Mr. DEIBEL. From a laboratory level, we always don’t understand 

what types of samples are coming into our laboratories. 

Mr. WALDEN. Right. 

Mr. DEIBEL. So it could be part of environmental monitoring 

where product fell on the floor and they want to test that. It could 

be—— 

Mr. WALDEN. OK, but couldn’t we—— 

Mr. DEIBEL. —processed samples. They could be doing a new 

R&D project. 

Mr. WALDEN. Right, but—— 

Mr. DEIBEL. We just don’t know. 

Mr. WALDEN. OK, but how hard would it be to have a row of 

boxes that says this is an R&D sample test, this is an off-the-floor 

sample, this is something that is going into the Austin crackers 

that some 3-year-old is going to eat? Is that that hard? 

Mr. DEIBEL. That wouldn’t be hard, however, I don’t know that 

that would happen. 

101 

Mr. WALDEN. All right. So if the private lab doesn’t collect the 

samples, how can you ensure the integrity of those samples? Can 

you, Ms. Cowart? They just send you whatever, right? 

Ms. COWART. Correct. What happens with our company is, we receive samples into our laboratory with a request for analysis and 

we do the analysis that was written on the request form. We do 

not know where the samples came from. We don’t know the history 

of them. And so our obligation as an independent laboratory is to 

run the test and to notify them with the accuracy and speed that 

we can to get them to them. 

Mr. WALDEN. And it sounds like you have a very thorough process to do that, which I commend you for, both e-mail and a voice 

process. 

Ms. COWART. Thank you. 

Mr. WALDEN. So let me go back to this notification. We learned 

yesterday or sometime this week that there is this mystery peanutprocessing plant in Texas that apparently has never been reviewed 

by the FDA, no regulators have been in there. Is that correct? 

Dr. SUNDLOF. No, sir. The FDA was in there in 2001 inspecting 

but at that time they were not producing peanut butter or peanut 

paste. 

Mr. WALDEN. Have you been back since they have been producing peanut butter or paste? 

Dr. SUNDLOF. Yes. I am sorry. Which plant are we talking about? 

Mr. WALDEN. The one in Texas. 

Dr. SUNDLOF. Oh, the one in Texas. I am sorry. Let me retract 

that. No, we had not been in there. 

Mr. WALDEN. Were you aware it even existed? 

Dr. SUNDLOF. We were. 

Mr. WALDEN. You were aware? Some of the news accounts indicate nobody knew this thing was going on, it wasn’t registered, 

wasn’t inspected. Do you know if it had been inspected? 

Dr. SUNDLOF. I don’t believe it had been inspected. 

Mr. WALDEN. So Mr. Deibel, if I understood you correctly, your 

company was actually doing tests from peanut product from that 

plant and discovered there was salmonella in some of that plant’s 

product. Is that accurate? 

Mr. DEIBEL. The Texas facility? 

Mr. WALDEN. Yes, sir. 

Mr. DEIBEL. That is correct. 

Mr. WALDEN. So if you had had to report that to the FDA, then 

the FDA would have known there was salmonella in a plant they 

had never inspected? 

Mr. DEIBEL. We did report that. 

Mr. WALDEN. To the FDA? 

Mr. DEIBEL. We reported this to the subcommittee. I am unsure 

if we reported it to—— 

Mr. WALDEN. Wait a minute. When did you do the salmonella 

test? 

Mr. DEIBEL. The result just came off this last Sunday. 

Mr. WALDEN. OK. So you just found out about this? 

Mr. DEIBEL. Yes. 

Mr. WALDEN. But you didn’t report that—I mean, you knew we 

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102 

text. You wouldn’t normally have sent us just sort of randomly test 

results, right? Of course not. But had you reported test results to 

anybody before? 

Mr. DEIBEL. We report test results to our clients but there is no 

mechanism currently in place to—— 

Mr. WALDEN. Right. And that is what we in the other context of 

the full are going to debate is, what is the mechanism that should 

be there. I mean, I am not an advocate of just sending enormous 

amounts of data to another government agency that will put it in 

boxes, it will go in a warehouse that will probably leak and we can 

produce peanuts there too. But, you know, it doesn’t make sense 

so it has got to be something that is usable. And so had you done 

tests prior to the ones this week on that plant in Texas? 

Mr. DEIBEL. We have been doing results for them for a number 

of years. 

Mr. WALDEN. A number of years, and had you spotted salmonella 

in any of those tests? 

Mr. DEIBEL. No, everything was negative up to the point of the 

results on Sunday. 

Mr. WALDEN. Dr. Cowart, did your firm do any tests on that 

plant in Texas? 

Ms. COWART. On the Texas facility, no, sir, we did no microbiology testing. 

Mr. WALDEN. And why do you think—I find it curious that your 

firm consistently found salmonella, you said six times in 2007 and 

four in 2008? 

Ms. COWART. That is correct. 

Mr. WALDEN. And then it sounds like PCA decided we are going 

to go somewhere else. Is that your read of it? 

Ms. COWART. After reviewing the documents and talking with 

our associates back at the laboratory, it appears that way, yes, sir. 

Mr. WALDEN. And then they sort of sent you one under the name 

of an internal operation just to, I guess, have you do that test. 

Ms. COWART. That is right, and again, not knowing the history 

of the samples, we just took the sample—— 

Mr. WALDEN. You do the test. 

Ms. COWART. —and we did the test. That is correct, yes, sir. 

Mr. WALDEN. Did you know whether or not PCA went to any 

other labs? 

Ms. COWART. We were aware of, they were asking us about a 

high coliform count and an aerobic plate count and so in an effort 

to answer their question, we did ask them if they could send us the 

results of the aerobic plate count and the coliform count just to 

compare, because we obviously go into a diagnostic mode also. 

Mr. WALDEN. Sure. 

Ms. COWART. And so we did know that they had used another lab 

for that, yes. 

Mr. WALDEN. And then do you like check the calibration of your 

equipment and all of that to just see? 

Ms. COWART. Yes, sir, we do, and we also run quarterly proficiency sample tests so that we can be able to check against an unknown sample that would come in from a proficiency organization. 

Mr. WALDEN. All right. And Mr. Deibel, do you have any idea 

why your data would be different than JLA’s data? 

103 

Mr. DEIBEL. Just based on—— 

Mr. WALDEN. How does that all work? 

Mr. DEIBEL. We are dealing with a dry commodity good, and as 

had been mentioned before, you know, water does play a role in 

these organisms, and so the results are not always going to be consistent within that sample and so you will get some degree of variability in those test results. 

Mr. WALDEN. I want to thank the witnesses for your testimony 

and for answering our questions. It is helpful in our efforts. 

Thank you, Mr. Chairman, for your indulgence. 

Mr. STUPAK. Thank you. 

Mr. Braley for questions, please. 

Mr. BRALEY. Thank you. 

Dr. Sundlof, as I understand it, the FDA did not conduct inspections of the PCA plant in Blakely, Georgia, from 2001 until January of 2009. Is that correct? 

Dr. SUNDLOF. That is correct. Now, we did again inspect in 2001 

and at that time they were not producing peanut butter or peanut 

paste. In I think it was 2007, the State of Georgia inspected under 

contract from FDA, so in essence, that was an FDA inspection in 

2007 and one in 2008. 

Mr. BRALEY. Well, after the recent salmonella outbreak was 

traced to peanut products in January of 2009, FDA conducted a detailed inspection of the PCA facility and issued an inspection report 

called a 483 report, and in that report you listed 12 occasions in 

2007 and 2008 when private labs informed PCA that its products 

tested positive for salmonella. I want to ask you about one of those. 

According to the 483 report, in June of 2008 the company received 

a private lab test that was positive for salmonella, and according 

to your report, the lot was manufactured on June 9 and the sample 

that tested positive was provided to the private lab on June 10. Is 

that correct? 

Dr. SUNDLOF. I believe that is correct. 

Mr. BRALEY. Dr. Sundlof, wasn’t June 10 the same day the Georgia Department of Agriculture inspected the facility on your behalf? 

Dr. SUNDLOF. I would have to check my records. 

Mr. BRALEY. Well, if that is the case and that is what the records 

show, the day after the company produced peanut products with 

salmonella, your inspectors were inside this facility but they didn’t 

detect salmonella because you didn’t direct them to test for it. Isn’t 

that true? 

Dr. SUNDLOF. That is true. 

Mr. BRALEY. And you had the legal authority to order those tests, 

didn’t you? 

Dr. SUNDLOF. Yes. 

Mr. BRALEY. So why didn’t you order salmonella testing that 

day? 

Dr. SUNDLOF. Well, first of all, we did not know of the test results at the time. We did not know those until January. Secondly, 

our policy had been that on routine inspections, and this is not forcause inspections, in other words, where we don’t suspect that 

there is a problem in the plant, we have not asked our inspectors 

in general whether it is the FDA inspectors of the inspectors under 

104 

contract to collect samples or obtain environmental samples. We 

are changing that now as a result of this. 

Mr. BRALEY. Well, does your office and do your inspectors apply 

a heightened degree of suspicion when there are other things going 

on in the food production business that might alert you to potential 

problems? 

Dr. SUNDLOF. Yes, we do. I mean, we take the entirety of all of 

the findings into account to determine whether or not it raises us 

to the next level where we would issue an inspection report of action, that there would be required actions to be taken by the company. In this case, I think all of the inspections that were conducted indicated that there were some infractions, that they didn’t 

immediately pose what appeared to be a risk to the safety of the 

food supply and that the company was correcting those deviations 

either while the inspector was in the plant or gave assurances that 

those would be corrected. 

Mr. BRALEY. Well, the reason I ask you that very specific question about a heightened index of suspicion is because in April of 

2007 this subcommittee held a hearing on a salmonella outbreak 

at the ConAgra peanut butter plant in Sylvester, Georgia, which is 

only 75 miles from the PCA plant, and that outbreak resulted in 

over 400 illnesses in 44 States. Wasn’t that cause enough for FDA 

to order testing for salmonella at the PCA plant? 

Dr. SUNDLOF. After that outbreak of Peter Pan, we went back 

and did a lot of education for the peanut industry. There was a 

seminar that was given in Atlanta in which the entire peanut industry was invited. We had FDA people there. They had other people talking about the kinds of measures that should be put in place 

in order to prevent this from happening in the future. We looked 

back at our records and determined that four people from PCA 

were registered to attend that particular symposium. 

Mr. BRALEY. So then you would agree with me that in this geographic area, in your State, there was certainly a heightened degree of suspicion about the potential for salmonella outbreak at the 

time these inspections were performed? 

Dr. SUNDLOF. Yes. 

Mr. BRALEY. And are there any written standards that apply to 

determine when there is for cause to test for salmonella? 

Dr. SUNDLOF. I don’t believe there is any written ones. I would 

ask Mike Chappell if he can comment on that. 

Mr. CHAPPELL. Well, after the ConAgra series, we did indeed provide some additional guidance to our field staff, and as Dr. Sundlof 

just mentioned, the realization is that we probably need to depend 

more on environmental sampling than we have in the past, not just 

the for cause, which means the conditions in the plant suggest 

there are serious problems. 

Mr. BRALEY. Mr. Chairman, it seems to me that private labs detected salmonella at the PCA facility but since they only reported 

it to PCA, the public never found out about it and that is a difference that we can’t afford to have in our food safety system, and 

I yield back. 

Mr. STUPAK. I thank you, Mr. Braley. 

Mr. Deal for questions, please. 

105 

Mr. DEAL. Thank you, Mr. Chairman. My line of inquiry is in two 

areas. First of all, what are manufacturers required to do, and secondly, what are State and federal authorities allowed to do. Now, 

in that regard, I would ask first of all, has peanut butter been classified by FDA as a high-risk product? 

Dr. SUNDLOF. I don’t believe it has. That may change in the near 

future. 

Mr. DEAL. Do you think that would be an appropriate classification? 

Dr. SUNDLOF. I believe so. 

Mr. DEAL. If it is so classified, what would change with regard 

to what the manufacturer must do and what the FDA and State 

authorities can do? 

Dr. SUNDLOF. Well, certainly considering it high risk, we would 

change the way that we inspect, and I think we just addressed 

that, that in the future we are in the process of writing all of our 

guidance to our inspectors that they will be taking samples of the 

product and the environment in the future and that will go a long 

way I think to detecting these problems earlier, but there is no— 

in terms of what is required under Good Manufacturing Practice 

standards, they are written rather broadly and they are written 

more for all foods than specific products, and as such they are not 

very prescriptive. You know, what will probably result from this is 

some stronger guidance that will be more specific about peanut 

butter as it pertains to the kind of manufacturing controls that 

need to be put in place and the kinds of inspections that we will 

do. 

Mr. DEAL. Can anything that FDA does by way of classification 

or otherwise require a peanut butter manufacturer to do product 

sampling with a specified period of regularity? 

Dr. SUNDLOF. Currently, the Good Manufacturing Practice standards are not written that way. 

Mr. DEAL. Do you think maybe they should be? 

Dr. SUNDLOF. Well, in my testimony I talked about putting more 

preventive controls, mandatory preventive controls in place in certain food facilities, and what we are talking about here, the term 

is the Hazard Analysis Critical Control Point, type of quality systems in which all of those kinds of things would be documented for 

any food process that falls under that kind of preventive control. 

Mr. DEAL. In the absence of requiring things like sampling and 

testing of those samples, then sampling and testing is a voluntary 

action on the part of the manufacturer. Is that correct? 

Dr. SUNDLOF. Currently, that is correct. 

Mr. DEAL. And the concern that some people have of requiring 

disclosure of those voluntary samples of disclosure of the results is 

that as long as it is voluntary, all that may very well do is to have 

less testing rather than more testing. Do you share that concern? 

Dr. SUNDLOF. Yes. 

Mr. DEAL. I am sorry I don’t have time for you to elaborate much 

on it. If you have that concern then, is that one of the things that 

your recommendations to Congress has included? Is that one of 

your recommendations? 

Dr. SUNDLOF. We will be working—we are more than happy to 

work with the Administration and the Congress to craft any new 

106 

legislation authorities that we need. I mean, I think the concern 

with us is that we need to make sure that it doesn’t discourage additional testing. In other words, if it is required, will companies actually do less testing because they know that the FDA will have 

access to those records. So it needs to be very carefully thought 

through how that process works. 

Mr. DEAL. Now, one of the problems I understand existed was 

that you could not access internal records and only had to go under 

the bioterrorism statutory authority in order to be able to get those 

internal records. Have you recommended or would you recommend 

that that be changed in terms of what the FDA or State authorities 

acting under your jurisdiction have the right to access internal 

records? Should they have that right? 

Dr. SUNDLOF. Yes. That is the other—again, we are working with 

the Administration on that but certainly if we had greater authority to access those kinds of records outside of the threshold that is 

required under the Bioterrorism Act to access those records, we 

would get a lot more information in a timely manner. 

Mr. DEAL. Mr. Garrison, I know that you act in conjunction with 

your contract authority with FDA to do inspections on their behalf 

that you are contracted to perform. Is that correct? 

Mr. GARRISON. That is correct. 

Mr. DEAL. And you have outlined the fact that money is a shortage factor and the number of inspectors are in short supply to do 

all that you undertake to do at the State level as well as in your 

contract capacity. Is that right? 

Mr. GARRISON. Yes, sir. Currently, we receive funding of about $123,000 through our FDA contract. The State funding for our food 

protection program is some $6 million. 

Mr. DEAL. I would ask this of both you, Mr. Garrison, and you, 

Dr. Sundlof, and that is, especially in the area of the FDA, we have 

seen that one of the ways to augment and get better results is 

through a user-fee program in which the producer has an incentive 

to have the testing done and in effect pays for that extra cost. We 

see it in other areas under FDA’s jurisdiction. Have you considered 

a user fee to fund the cost for additional inspections at the federal 

level and/or the State level? 

Dr. SUNDLOF. Thank you. We are responding to legislation proposed, the Food Globalization Act, in which user fees are part of 

that, and we will be submitting formal responses and technical assistance on that bill. 

Mr. DEAL. At the State level, Mr. Garrison, are user fees contemplated? 

Mr. GARRISON. I would have to say that would be a pay grade 

above myself. That would be something that Commissioner Irvin 

and the State legislature and the governor would have to take up. 

Mr. DEAL. It is not in the current proposed legislation then? 

Mr. GARRISON. Not that I am aware of, no, sir. 

Mr. DEAL. Thank you for the extra time. 

Mr. STUPAK. Ms. Christensen for questions. Oh, I am sorry, excuse me, Mr. Dingell for questions, please. 

Mr. DINGELL. Well, Mr. Chairman, first I want to commend you. 

This is a continuation of the excellent hearings which you had in 

the last Congress, and I want to commend you for your vigor and 

107 

your energy and your enthusiasm and for the success of your efforts. You are going to make possible major reform here and I want 

to commend you for that. 

These questions are all to Dr. Sundlof. Please, Doctor, answer 

yes or no because we have relatively little time in which to do this. 

Food processors should be made to notify the FDA when they begin 

producing products that have not previously been registered. Do 

you agree, Doctor, yes or no? 

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

Mr. DINGELL. Please pay attention because we do have limited 

time here. Food processors should have to notify FDA when they 

begin producing products that they had not previously registered. 

Do you agree? 

Dr. SUNDLOF. Yes. 

Mr. DINGELL. In light of the current crisis with regard to Food 

and Drug and producers, should foreign and domestic food facilities 

be required to have safety plans in place to identify and to mitigate 

hazards? 

Dr. SUNDLOF. In some cases, yes. 

Mr. DINGELL. Now, what should these plans, rather should these 

plans be subject to review by FDA inspectors? 

Dr. SUNDLOF. Yes. 

Mr. DINGELL. Would increase in inspections by FDA have potentially prevented the salmonella outbreak? 

Dr. SUNDLOF. It is potentially possible, yes. 

Mr. DINGELL. In other words, more frequent and more thorough 

inspections by Food and Drug would have done so. Is that right? 

Dr. SUNDLOF. Yes. 

Mr. DINGELL. Now, if FDA had better traceback capabilities, 

would that have helped prevent this salmonella outbreak? 

Dr. SUNDLOF. It would have helped us recall product quicker. 

Mr. DINGELL. Now, should testing done on food products be subject to certain safety requirements and be performed only by a laboratory accredited by FDA? 

Dr. SUNDLOF. I have no opinion on that at this time. 

Mr. DINGELL. You will note that you had a number of laboratories which performed tests that either didn’t reveal the presence 

of salmonella or that were not reported to FDA. If FDA had had 

reliable reports from reliable laboratories, would it not have been 

better able to protect the public? 

Dr. SUNDLOF. Yes. I want to just say about salmonella testing, 

you can test the same product several times and not find the salmonella and it can be still in there. We suspect that these were all 

good laboratories and that the failure to confirm a positive was not 

the laboratory’s fault but the sampling. 

Mr. DINGELL. I am driven to the unfortunate conclusion that if 

that statement is true, Food and Drug probably could have done 

without laboratory inspections at all because apparently the laboratory inspections either didn’t get communicated to FDA or they 

didn’t reveal the presence of salmonella, and how does Food and 

Drug do its job without proper assistance in identifying the presence of pathogens like salmonella? 

Dr. SUNDLOF. We rely heavily on States and private laboratories 

and others to help us in our mission. 

108 

Mr. DINGELL. It sounds like you are saying trust everybody. I 

would add to that my dad’s abjuration that you should always cut 

the cards. Now, in light of the salmonella outbreak caused by 

PCA’s products, could this crisis have been mitigated if testing laboratories were required to send their testing results to FDA? 

Dr. SUNDLOF. It would have alerted us a lot sooner, yes. 

Mr. DINGELL. I am sorry? 

Dr. SUNDLOF. It would have alerted us sooner than that there 

was a problem. 

Mr. DINGELL. So you need both qualified and competent laboratories and you need to have them registered and you need to have 

them send their results to Food and Drug so that you know what 

is going on, right? 

Dr. SUNDLOF. Again, we appreciate all the information that we 

can get. 

Mr. DINGELL. OK. Should FDA have authority to issue mandatory recalls of tainted foods? 

Dr. SUNDLOF. We are more than happy to discuss that. It depends, I believe, on how the law is written and what—— 

Mr. DINGELL. You do not have that authority now. 

Dr. SUNDLOF. We do not. 

Mr. DINGELL. And you need it if you are to do your job effectively, do you not? 

Dr. SUNDLOF. It would be helpful, yes. 

Mr. DINGELL. More than helpful, it is necessary. Isn’t that so? 

Dr. SUNDLOF. I can tell you that almost in every case when we 

ask companies to recall product, they do it voluntarily. 

Mr. DINGELL. Now, Food and Drug was not able to visit or inspect the Peanut Corporation of America for about 8 years. Is that 

right? And then they turned the matter over to Georgia, which in 

2 years is supposed to have visited PCA but they didn’t find a 

thing. What caused the failure of FDA to be able to inspect the people who were subject to their jurisdiction? I am told that the Department of Agriculture can investigate and can visit and inspect 

dog food producers oftener than Food and Drug can inspect food 

producers. Do you need more resources at Food and Drug to carry 

out proper inspections or not? 

Dr. SUNDLOF. We would like to do more inspections, yes. 

Mr. DINGELL. Well, you are not doing the inspections that need 

to be done so you are not able to protect the people. PCA tells us 

clearly that the consumers were not protected because tainted and 

unsafe salmonella-infected peanut products and peanut butter got 

on the market, and with more resources you could have done a better job of protecting the public. Is that not so? 

Dr. SUNDLOF. It is not clear in this case. 

Mr. DINGELL. It is not clear? 

Dr. SUNDLOF. It is not clear—— 

Mr. DINGELL. In 8 years you couldn’t investigate them. That is 

clear to me. Then Georgia investigated them and they couldn’t do 

a good job. So that tells me that Food and Drug does not have either the resources—you are caught in a cleft stick here. Either you 

don’t have the resources or you are incompetent to do the job you 

are supposed to do. Which conclusion am I to arrive at? 

Dr. SUNDLOF. I would hope the former. 

109 

Mr. DINGELL. That you don’t have the resources? I am content 

to believe that you are incompetent but I have tried to defend you 

against that and point out that you need resources. What I get 

from you, however, is, a modified reluctance to have more resources, and I am distressed because I think that the only way 

Food and Drug is going to amount to a hill of beans is to have the 

resources that it needs and to have the statute that it needs and 

to have the leadership that it needs. I find the leadership lacking, 

I find the resources lacking, and you are driving me to the conclusion that perhaps maybe Food and Drug is not as diligent as it 

should be because it might have the resources. Now, what is your 

response to that? 

Dr. SUNDLOF. Well, obviously we need to be inspecting more frequently. In this particular case, we should have been taking environmental samples. That would have led us to find problems earlier. We should have been more directed to the State of Georgia in 

directing them to take environmental samples. Had they done that, 

we might have detected this sooner. 

Mr. DINGELL. Mr. Chairman, my time has expired. You have 

been very gracious. I thank you. 

Mr. STUPAK. Well, thank you, Mr. Dingell, and on behalf of all 

the members, when they were doing the tribute on the floor on 

your resolution, we all would have liked to have been there but we 

were doing as you have taught us to do, oversight, so forgive us for 

not being there when they did the House resolution in tribute to 

your longevity on the floor. I know some of us after hours tonight 

will be paying tribute to your length of service, but more than that, 

the quality of service you provided to the American people. 

Mr. Gingrey for questions, please. 

Mr. GINGREY. Mr. Chairman, thank you, and following up on the 

chairman emeritus’s line of questioning, let me address my first 

question to Dr. Sundlof of the FDA. You know, I think as I read 

your testimony that FDA actually went into Blakely, Georgia, to inspect this PCA plant on January 9, 2009, and this was based on 

the information that had been obtained by Minnesota Department 

of Public Health that clearly there was salmonella in an open container of this peanut butter product, and yet you go there and you 

find pretty quickly in going through the records of the company 

that some of the lab reports that were submitted by these two labs, 

these private labs, which by the way I don’t feel are necessarily responsible for not notifying the FDA. I mean, their job is basically 

a contract with the company. It is just like if a physician does a 

blood sample on someone and sends it to a lab and it is a low hemoglobin, as an example. Well, the laboratory is going to report 

back to the doctor and maybe even flag that, particularly if it is 

a dangerously low number, but that is where their responsibility 

ends. I mean, they cannot run down every patient and interfere 

with a doctor-patient relationship. So it may be that that is something that we should change, and I will get to that question in just 

a minute. But my question to you is, FDA went in and knew on 

January 9 beyond a reasonable doubt that this was the source of 

the contamination and yet waited another 10 days or so to get 

some unopened can of peanut butter from somewhere in Connecticut to absolutely, unequivocally prove it. Couldn’t you have 

110 

had the ability to say to the company, cease and desist until we can 

prove this? If we disprove it, then, you know, you continue operations and maybe the Federal Government, the FDA mitigates any 

financial loss but when you just continue to get to the nth degree 

for another 10 days, I don’t now how many more hundreds of people got sick or maybe even additional deaths because of that delay. 

Why couldn’t you have issued a cease-and-desist order at that 

time? 

Dr. SUNDLOF. I believe we went in on the 9th. I believe that was 

a Friday. The company recalled on the following Monday. So we did 

move very quickly. 

Mr. GINGREY. Well, the company recalled a certain product that 

was produced and then it was later that they recalled it and then 

finally they had another recall that went all the way back to January 2007, but that probably should have been done immediately. 

Dr. SUNDLOF. We can only work with the information that we 

have at the time. At that time we only knew of the products, the 

King Nut products as being the source. We moved quickly. They 

quit producing on that date and quit marketing on that date, on 

the 9th of January, and started recall of the products that we knew 

were affected by the following Monday. 

Mr. GINGREY. Let me move on to Mr. Garrison with the Georgia 

Department of Agriculture. Do you feel like the Department under 

contract with the FDA had sufficient training? Were there any 

manuals in regard to the inspectors that work with the Department of Agriculture? Did you have enough training and guidance 

to properly inspect? 

Mr. GARRISON. Training is always a continual issue when you 

are looking at the evolving food continuum that we see. There have 

been a lot of advances in food processing, a lot of new programs 

brought online, as Dr. Sundlof stated, Hazard Analysis Critical 

Control Point. Those inspections are now required in seafood processors and in juice processors. So where there is specific training 

required of an operator of a facility, then our inspectors are also 

provided with that training. We have taken the Good Manufacturing Practices from FDA. Those are adopted in the State regulations and those are also in our performance manual that—— 

Mr. GINGREY. And Mr. Garrison, did the Department abide by 

the terms of the contract in regard to the frequency of inspections? 

Mr. GARRISON. Yes, sir. The terms of the contract only lays out 

one inspection in the assigned facilities during a calendar year unless there is an indication by FDA that a follow-up would be necessary based on documentation. 

Mr. GINGREY. Let me real quickly ask our lab folks, if you will 

bear with me, Mr. Chairman. If you were required to submit a copy 

of your report, certainly a positive report, let us say, to the FDA, 

how much more expense or burden would that be for the laboratories? How much more would you have to charge the food processor that contracted with you to do the lab testing if you were required to submit a duplicate copy to the FDA? 

Ms. COWART. Mr. Gingrey, I can speak specifically for our company. All of our documents are e-mailable in a new system that we 

have put in place since August of 2007 so it would be very simple 

to e-mail to whoever in FDA would be the appropriate person. 

111 

Mr. GINGREY. Mr. Deibel, would you agree with that? 

Mr. DEIBEL. Yes. We have a system where we can plug in on 

each client each client contact that would want a report. The system, once we go through our checks and balances to ensure that 

the result is accurate and authorized, once that is authorized, it is 

automatically either e-mailed or faxed to whomever. 

Mr. GINGREY. So easily done, not expensive and nothing you 

would object to if we decide that that should be done in the future? 

Mr. DEIBEL. If that was something that this body decided, it 

would not be a problem. 

Mr. GINGREY. Mr. Chairman, I will yield back. I know my time 

has expired. 

Mr. STUPAK. Ms. Christensen for questions, please. 

Ms. CHRISTENSEN. Thank you, Mr. Chairman. 

I would like to direct my first question to Dr. Sundlof also. I had 

a chance to look through some of the Senate testimony and the director of food safety for the Center for Science and Public Interest 

had what I am going to read to you in her testimony. She says that 

in April of 2008, Canada rejected a shipment of peanuts from PCA 

as unfit for food. PCA attempted to clear the peanuts for sale in 

the United States but FDA rejected its test results and eventually 

the peanuts were destroyed. During that period—well, wouldn’t 

that have sent a red flag up to FDA and shouldn’t that have caused 

FDA to require more inspections of PCA, given the fact that this 

is April of 2008? Because the testimony goes on to say that FDA 

did not follow up with inspection of the plant. 

Dr. SUNDLOF. That is not entirely true. The shipment was rejected because it was peanut granules and it was determined that 

it contained some metal fragments in there. It was returned back 

to PCA. FDA witnessed its destruction so that it did not move into 

commerce. At that time we also asked that the State of Georgia do 

an additional inspection in that facility. That was one of the two 

that was conducted under FDA contract and they went in there I 

think in May or June was when they went back in to inspect. I believe they determined what the source of the metal was and the 

firm took corrective action. 

Ms. CHRISTENSEN. And Mr. Garrison, you are familiar with those 

inspections. 

Mr. GARRISON. Yes, ma’am. 

Ms. CHRISTENSEN. Was it your testimony that you found no evidence for any contamination in those inspections? Was it a complete inspection or was it just related to the metal? 

Mr. GARRISON. What the e-mail that we received from FDA stated was, it was to be a contract inspection and focusing on GMPs, 

which is what the contract states, and also looking for any metal 

inclusion that may have occurred and to check out the metal detector. What we reported back to FDA was a couple of metal scrubbers, which we would call a brillo pad, that were inside the facility 

and also a scraper—— 

Ms. CHRISTENSEN. But that would not have precipitated any 

other inspections? Was it focused just on the metal? 

Mr. GARRISON. No, ma’am. We actually had done a Good Manufacturing Practice inspection during that time. 

112 

Ms. CHRISTENSEN. And there was nothing to suspect that there 

would be any other contamination in those inspections? 

Mr. GARRISON. Like I said, there was no red flags that would indicate an imminent health hazard inside that facility. 

Ms. CHRISTENSEN. My understanding, Mr. Garrison, is that between 2007 and 2008, PCA had 12 positive salmonella tests reported to them, and in that time the Department tested 35 product 

samples from five Georgia facilities. How many of those were from 

the Blakely plant? 

Mr. GARRISON. There were three samples taken from the Blakely 

plant in believe August of 2007. 

Ms. CHRISTENSEN. And their first positive was in June of 2007, 

but you didn’t find any in your three? 

Mr. GARRISON. No, ma’am, we did not. 

Ms. CHRISTENSEN. Since there has been a salmonella outbreak 

the year before that was in peanut butter, when this outbreak 

started to surface, did that not raise concern and should not that 

have precipitated some increased inspection at peanut butter 

plants, for either Dr. Sundlof or Mr. Garrison. 

Mr. GARRISON. From the State perspective, when the outbreak 

began we worked closely with our department of Public Health and 

their epidemiologists were monitoring the CDC calls looking for potential causes and implicated foods and then they would bring 

those to us. You know, once the peanut butter was brought forward 

as a potential, then at that point the State along with FDA began 

looking at potential problems that may be associated with those facilities. 

Ms. CHRISTENSEN. But nobody seemed to think back to March of 

2007 to say well, this is salmonella, we had a salmonella outbreak 

a year before where the source was peanut butter? 

Mr. GARRISON. From a State perspective, we are constantly shuffling resources. You know, when we can run 45 samples through 

our laboratory, you know, coming into June we were dealing with 

imported jalapeno peppers that, you know, actually tainted our tomato industry in Georgia. We had melamine in products coming 

from China that the State was running tests on in October so, you 

know, with very limited lab resources, we are constantly moving 

around what we are testing and what we are looking for from a 

State standpoint. 

Ms. CHRISTENSEN. If I can get just one more question, a quick 

question, to Mr. Deibel and Ms. Cowart. The fact that there was 

a negative follow-up test after a positive one, how many negative 

tests would you consider enough to convince you that the positive 

test result could be ignored? Can you ignore a positive test just because you get another follow-up? 

Mr. DEIBEL. Absolutely not. If you tested 50 samples for a given 

lot and 49 of those were negative and one was positive, that one 

positive must trump the 49 negatives. The 49 negatives should 

never have more precedence over that one positive. You cannot 

retest away a positive result. 

Ms. COWART. And I will agree with that statement wholeheartedly. 

Ms. CHRISTENSEN. Thank you, Mr. Chairman. 

Mr. STUPAK. Thank you. 

113 

Ms. Schakowsky, questions, please. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

Mr. Deibel, on April 28, 2008, your lab confirmed that a PCA 

sample tested positive for salmonella contamination. Is that correct? 

Mr. DEIBEL. I believe so. Yes. 

Ms. SCHAKOWSKY. I think you said before, what would you have 

expected a manufacturer to do with that information? 

Mr. DEIBEL. We do a lot of consulting services for our clients and 

most of what we try to get involved with is more on the front-end 

quality control procedures, working with clients to have—— 

Ms. SCHAKOWSKY. What would you have expected that they 

would do? 

Mr. DEIBEL. In the event of a positive occurrence, we would expect that they would shut that line down or stop that production, 

quarantine that lot, try to figure out how that positive occurred in 

retesting. 

Ms. SCHAKOWSKY. OK, but—— 

Mr. DEIBEL. But ultimately throw it out. 

Ms. SCHAKOWSKY. But actually following that initial positive, 

PCA sent you additional samples from the same lot and they also 

went to Dr. Cowart’s firm and provided an additional sample, and 

those tests came back negative for salmonella, right? 

Mr. DEIBEL. Correct. That is not unheard of. 

Ms. SCHAKOWSKY. Dr. Garrison, what is a company expected to 

do if there is a positive? And do you also agree that negatives don’t 

erase the positive that has been found? 

Mr. GARRISON. The State of Georgia Department of Agriculture 

would expect that company to immediately destroy the product. If 

it has been put in commerce, it would expect them to recall that. 

During our testing procedures, when we get what Ms. Cowart had 

referred to as a presumptive positive from a facility we regulate, 

we will notify industry at that point, and in most cases, as a matter of fact, in all cases from that presumptive positive, the processing facility will either hold the product if it hadn’t went out or 

go ahead and issue a recall just based on that presumptive. 

Ms. SCHAKOWSKY. OK. Now, between June of 2007 and September of 2008, private lab testing found salmonella on 12 separate 

occasions. You inspected the plant on June 10, 2008. Did you ask 

if there had been any laboratory tests? 

Mr. GARRISON. There is no evidence on our inspection reports 

that we asked but that is something that the company does not 

have to supply to the State. That is the reason—— 

Ms. SCHAKOWSKY. Do you ask though? 

Mr. GARRISON. I can’t say in this particular instance if we asked 

or not. 

Ms. SCHAKOWSKY. Is it on your report form to ask? 

Mr. GARRISON. No, ma’am, it is not something that is required 

of—— 

Ms. SCHAKOWSKY. I know it is not required. I am just wondering 

if you asked and if the company refused to tell you because they 

don’t have to, would that not indicate that there might be some 

sort of a problem? I mean, I don’t understand. If there has been 

test after test, I think everybody here agrees that a positive test 

114 

should result in a product being taken away. I think we will 

change that. I hope we will change that so they do have to inform 

you, but I can’t understand why that question wouldn’t be asked. 

Can you explain that to me? 

Mr. GARRISON. When companies are not required to give records, 

we don’t even know if tests have been conducted. 

Ms. SCHAKOWSKY. Exactly. 

Mr. GARRISON. And when you are dealing with the elements that 

we are dealing with in this case, if we think by simply asking they 

would tell us that they didn’t have the results or that they were 

all negative, you know, we are dealing with a different element 

here. We are dealing with something that at this point appears to 

have intention based in it. 

Ms. SCHAKOWSKY. There is at tab 42 an e-mail from Stewart Parnell, the owner of PCA, and in these e-mails with the plant manager, Sam Lightsey, Mr. Parnell inquired about the results of a 

subsequent test from Deibel. Mr. Lightsey informed Mr. Parnell 

that the subsequent tests were in spec, meaning they came back 

negative for salmonella. Although Mr. Parnell knew that this lot 

previously received a confirmed positive for salmonella, Mr. Parnell 

instructed this plant manager, ‘‘OK, let’s turn them loose then.’’ Dr. 

Sundlof, is this the appropriate response to these two tests, to turn 

the product loose on American consumers? 

Dr. SUNDLOF. No, it is not, and I don’t believe that is in any way 

the industry practice. I think this is a case in which one company 

has violated what I think all other companies know. It is well 

known within the peanut manufacturing community that testing, 

even finding a negative is not conclusive, that you have to take 

many tests, and that certainly once you find a positive test, that 

that product cannot be considered to be safe. 

Ms. SCHAKOWSKY. When you conduct tests as the FDA, do you 

ask if any tests have been conducted? 

Dr. SUNDLOF. I think we do but I am going to ask Mike Chappell 

to speak to that. 

Mr. CHAPPELL. It certainly depends on the nature of the inspection. If you are asking whether it is a routine requirement for our 

investigators to ask for whatever testing, that is not our procedure, 

but we are changing that procedure to require that our investigators do ask what testing is being done and ask to have access to 

those records. 

Ms. SCHAKOWSKY. Well, hopefully, Mr. Chairman, we are going 

to require that those tests get reported back to the FDA. I just 

want to say that it is really unbelievable that Mr. Parnell knew 

that the food that he produced was contaminated. It escaped any 

inspections by the State. Even though the testing laboratory found 

that there was a positive, nothing happened, and rather than be 

responsible, destroying these tainted products, he chose to test the 

same lot over again until he got the result that he wanted and then 

released the product to the public. We have a responsibility to 

change that. Thank you. Thanks for the extra time. 

Mr. STUPAK. That concludes all the questions of the members in 

this round. I am sure we are going to go a second round but we 

do have two members of the full committee who are not members 

of the subcommittee but they are allowed to ask questions under 

115 

the rules of the subcommittee. So Mr. Barrow, I know you have 

been here all day. Would you like 5 minutes of questions? 

Mr. BARROW. Yes, sir. Thank you, Mr. Chairman. 

I am not as good a cross-examiner as my hero, Mr. Dingell here, 

and I am not as good as Mr. Braley over there so I am going to 

throw you guys a softball. I want to ask you a wide-open-ended 

question, but listen to the conditions of it because it might not 

seem that way, especially you, Dr. Sundlof. If you believe that the 

integrity of testing cannot be separated from the integrity of sampling, and the sampling and testing are both things that have to 

have integrity, if you want to preserve the existing regime of voluntary inspections and confidential reporting with the testing community but you feel it is necessary to mandate and superimpose on 

that a mandatory sampling and testing regime, if you want to 

make sure that the sampling and testing that is done isn’t too rigorous that you put folks out of business but isn’t too lax to miss 

stuff you need to know, in other words, if you want to do everything you reasonably can to make sure first that the manufacturer 

knows what the manufacturer needs to know when the manufacturer needs to know it and you want to make sure that the regulator knows what the manufacturer knows, whatever it is, when 

they know it, how do we go about doing that? Dr. Sundlof, you go 

first, please. 

Dr. SUNDLOF. Thank you. One of the things that again we will 

be asking for more authority, and that is to issue preventive controls in plants. That is, they have to have a quality system in place 

that specifies where the critical control points are, where contaminants can be introduced—— 

Mr. BARROW. Is a sampling and testing regime going to be a part 

of that? 

Dr. SUNDLOF. Absolutely. 

Mr. BARROW. Is there going to be goals or is it going to be 

quotas? Is it going to be something we think folks out to look at 

or is it going to be something folks are going to be required to do? 

Are you going to have different protocols for different sectors of the 

food-processing industry? 

Dr. SUNDLOF. Manufacturers will have to develop their own 

HACCP plan which is specific to their particular manufacturing facility. 

Mr. BARROW. Are you going to require sampling be done by folks 

who have an independent stake in their work, folks who don’t work 

for just one person or work within the community but who have a 

whole bunch of clients who actually stand to lose a lot if they don’t 

do their sampling and their testing in a credible manner? 

Dr. SUNDLOF. I mean, I can’t speak about how the exact program 

would work but certainly there has to be these checks and balances 

in there that can be verified by the FDA. 

Mr. BARROW. You will agree with me that folks can’t be allowed 

to sample and test themselves? 

Dr. SUNDLOF. I am not completely sure about that. 

Mr. BARROW. When I was a boy, I learned at my daddy’s knee 

that no person can be the judge of his own case. Don’t you all know 

that? 

116 

Dr. SUNDLOF. There may be ways that we could ensure the integrity even if they sample their own product and test their own product. 

Mr. BARROW. I am not saying folks can’t be allowed to do that. 

I am saying we need to have a sampling and a testing regime in 

place in addition to the powers of mandatory recall that folks have 

talked about. We need to have a system in place where the manufacturer really doesn’t have the option of knowing what they need 

to know when they need to know it and they don’t get to be the 

only ones who decide to act on that information. The public regulator needs to know what they know and when they know it. Don’t 

you think that is necessary, that that is a goal we need to reach 

for? 

Dr. SUNDLOF. Yes, and that is what we are requesting. 

Mr. BARROW. Well, that remains to be seen. Thank you. 

Anybody else want to take a stab at any of that with a little time 

left? How about you, Mr. Deibel? I understand the point you are 

making but you realize the point I am making, don’t you? I am not 

trying to drive people out of the business knowing more than they 

need to know but I want to make sure they know what they need 

to know and that we know what they know when we need to know 

it. 

Mr. DEIBEL. I think there are a lot of opportunities in the subcommittee and in the discussions that we are going to be having 

to really build stronger bridges between government and industry 

and agree upon best practices that we can all use. I hope those best 

practices include preventative approaches rather than reactive approaches—— 

Mr. BARROW. Well, what I want to do is, I want to take you guys 

out of the situation of having to rat out a client, an existing regime 

where folks have the right to come to you and ask as a matter of 

entering into the contractual relationship with you that you will 

keep quiet but that puts you in an untenable position. That is unacceptable. I recognize your interests there. Nobody can go forward, 

no part of the existing system can go forward to start doing the 

right thing if everybody else is going to continue to be allowed to 

do the wrong thing. So I want to put in place something that 

doesn’t let that happen. 

Ms. Cowart, do you have anything to add to that? 

Ms. COWART. No, sir, I agree with that in terms of what you are 

talking about. I think the broader picture of how that gets done is 

something that we would really like to be a part of helping with 

the solution. 

Mr. BARROW. Well, get ready because I think you are going to 

have a chance to play a role in that. 

Ms. COWART. Thank you. 

Mr. BARROW. Thank you, Mr. Chairman. 

Mr. STUPAK. Mr. Pallone for questions. You are the chairman of 

the Health Subcommittee with our legislation and FDA 

globalization bill that we are trying to get through for food and 

drug safety, so glad to have you here. 

Mr. PALLONE. Thank you, Mr. Chairman. I wanted to be here for 

the whole hearing but I had a hearing on offshore drilling in my 

other committee, and that is important in my district so that is 

117 

why I couldn’t come until now. But I did want to mention, you 

mentioned the comprehensive FDA bill that you and Mr. Dingell 

have introduced and I just wanted to say that I was pleased to see 

that we included some of the provisions in a food safety bill that 

I have been trying to push for a number of years that are now in 

that comprehensive bill, specifically preventative measures to ensure that food safety has been addressed. 

I wanted to ask Mr. Sundlof a question. In the case you are examining today, many more companies than just PCA have been involved. In fact, over 50 companies use PCA’s peanuts in their finished products, and what worries me about the situation is that 

first PCA did nothing to prevent their contamination, and as others 

have highlighted, knowingly put contaminated products on the 

market, but second, none of those other companies conducted adequate tests on their food items to detect and stop the tainted peanut products from making their way to consumers, and under current law there is no requirement that the companies who are actually putting food into the hands of consumers audit or check up on 

their supplies to ensure the ingredients they are getting from these 

suppliers are safe. Now, I believe that we need to give the FDA the 

authority to require food manufacturers to establish food safety 

plans and these plans would require food companies to evaluate 

what food safety risks exist, determine how best to address and 

protect against those risks and establish processes and procedures 

to control those risks. Finally, these food safety plans would require companies to maintain records documenting that they have 

complied with those plans and those of course would be available 

to the FDA. You mentioned all this in your testimony but I just 

wanted to make it clear, you do agree that the FDA should have 

this authority to require these manufacturers to establish food 

safety plans? 

Dr. SUNDLOF. Yes, I do, and in fact, we do have two areas of food 

that do require these kinds of preventive control systems. One of 

them is seafood and the other one is juice. They have to produce 

them under a HACCP program. 

Mr. PALLONE. Now, do you also agree that having these sorts of 

requirements in place would have gone a long way towards avoiding the kind of major catastrophe that occurred here? 

Dr. SUNDLOF. It is unclear because the company, it is not clear 

they would have kept adequate records in this case because they 

did get positive samples and those chose or they shipped product 

anyway. If we had gone in and inspected their records and had gotten access to those records before this outbreak, certainly that 

would have been a warning to us and we potentially could have 

prevented this. 

Mr. PALLONE. I mean, just in a general sense, would you agree 

that each company in the chain of manufacturing has an obligation 

to ensure that the ingredients they are using as well as their final 

products are safe for Americans to consume? 

Dr. SUNDLOF. Yes, absolutely. 

Mr. PALLONE. And then the second thing, Mr. Chairman, I wanted to ask was about the fines. Mr. Sundlof again, PCA knowingly 

put contaminated products on the market. They knew their ingredients were going to be used by many companies in their various 

118 

products. They knew the risks of this disease and yet they did 

nothing, but the most alarming thing to me is the lack of repercussions for the behavior. Under current law, the more severe penalty 

available for committing a single prohibited act with respect to 

foods is a misdemeanor, which carries a potential sentence of imprisonment of up to 1 year or a monetary fine. But the FDA to successfully prosecute these companies and impose a penalty has a 

lengthy investigation and has to coordinate with the Justice Department and it is highly intensive in terms of the resources of the 

FDA and Justice. I also question whether the threat of a misdemeanor conviction has any deterrent effect at all, especially in 

light of the situation. FDA now has the authority to levy civil monetary penalties for certain drug and medical device violations, an 

administrative authority that permits FDA to proceed without involving the Justice Department, and for certain drug violations 

FDA can impose a fine of up to $1 million for all violations adjudicated in a single proceeding but FDA does not have that authority with respect to foods with the exception of illegal pesticides. In 

your opinion, are civil monetary penalties less burdensome for the 

agency to impose than criminal penalties, and do you agree that 

having the ability to impose an administrative monetary fund 

would be a useful enforcement tool for the FDA? 

Dr. SUNDLOF. Congressman, it is not something that I have had 

discussions with. Certainly it is something that we will be talking 

about in the wake of this salmonella outbreak but it is not something I have an opinion on at this point. 

Mr. PALLONE. And you don’t want to express an opinion at this 

point? 

Dr. SUNDLOF. I don’t. 

Mr. PALLONE. All right. I wish you would, but I can’t force you. 

Thank you, Mr. Chairman. 

Mr. STUPAK. Thank you, Mr. Pallone. 

Let us go for another round. I think we are going to have votes 

here soon but let us try to get a couple more questions in before 

we release this panel. 

Mr. Garrison, when I take a look at the document binder, it 

seems between Exhibits 15 to 37 are Georgia’s inspections of this 

place, and if I am correct—by ‘‘this place’’ I mean PCA. That is 

about 22 different inspections, and it looked like early on, 2004, 

2005, 2006, you did not only inspections but also scale inspections. 

Is that correct? 

Mr. GARRISON. Yes, sir, that is correct. 

Mr. STUPAK. Then why the drop-off after 2006? I think you had 

one in 2007 and one in 2008? 

Mr. GARRISON. On the scale inspections or on the food inspections? 

Mr. STUPAK. Both. 

Mr. GARRISON. The scale inspections were conducted under another section of my division. On the food inspections, it was basically due to attrition throughout the department. 

Mr. STUPAK. And budget cutbacks you spoke of? 

Mr. GARRISON. Budgetary issues and those type of things. 

119 

Mr. STUPAK. So you never did any inspection of this plant, the 

Blakely, Georgia, plant, for salmonella then even though that was 

sort of the goal to do it once a year, right? 

Mr. GARRISON. No, sir. We would have done an inspection at 

least twice per year during this period of time. 

Mr. STUPAK. But let me ask you this. Had you ever had any 

knowledge, anyone in your department or agency, that they were 

having trouble with salmonella at this plant in Blakely, Georgia? 

Mr. GARRISON. No, sir, it was never reported to any of our inspectors or even through our consumer complaint logs. 

Mr. STUPAK. OK. Your last inspection was October 23, 2008, and 

when you take a look at it, it has a little bit of history of past problems that they had in this place, especially water. Water is sort of 

a red flag in peanut butter that there could be contamination or 

salmonella. Isn’t that so? 

Mr. GARRISON. You want to eliminate moisture from the peanut 

process. 

Mr. STUPAK. And that is even one of the reasons why you roast 

peanuts and heat them up is to get rid of the salmonella? It has 

to be more than 170 degrees, if I remember correctly, correct? 

Mr. GARRISON. The temperature would really depend on the 

roaster speed and the temperature there. It is a combination of the 

two during the roasting procedure. 

Mr. STUPAK. OK. On October 23, when you take a look at it, and 

I am looking at the FDA’s report in January, they indicate even in 

October like they are missing dates as to the firm’s temperature inadequate or just left off the reporting charts, and that was never 

noticed by your inspectors. Wouldn’t they look for the temperatures 

for roasting peanuts if you are doing an inspection? 

Mr. GARRISON. When our inspectors go in, they will look at the 

current temperatures are being observed at the time that they are 

inside. 

Mr. STUPAK. They wouldn’t look at past temperatures to see if 

they are being reported? 

Mr. GARRISON. Those would be records that they would not have 

to supply us with. 

Mr. STUPAK. I had asked Ms. Cowart, and it was Exhibit 38 

there, when she did a walk-through when she was consulting with 

PCA and she found three reasons why there could be salmonella, 

number one, the Chinese product could have already been contaminated before it got there, but then after that it was in the production and packaging. If Ms. Cowart, if she just does a walk-through 

and notices these things in this plant, why wouldn’t your inspectors 

notice them because they are looking for the same things, aren’t 

they? 

Mr. GARRISON. Ms. Cowart had knowledge that the facility had 

a problem with salmonella. That is something that the State didn’t 

have and that is what we are pushing for is for these plants in 

Georgia if they have problems, they have to let us know. We have 

to have every tool available to us. 

Mr. STUPAK. Sure, but as inspectors, salmonella, water, peanuts, 

bad combinations. I just think you would pick up on those things. 

120 

Mr. GARRISON. Exactly. You know, the inspections are a snapshot 

in time. What Ms. Cowart had seen during her inspections may not 

have necessarily been there when our inspectors went through. 

Mr. STUPAK. Well, that is why you look at the temperature 

records and things like that, correct? 

Mr. GARRISON. When they have to supply them to us. That is 

why we go back to the HACCP requirements that Dr. Sundlof 

spoke about with the juice HACCP and the seafood HACCP. They 

are required to maintain those records, to sign off on those 

records—— 

Mr. STUPAK. But there is no way you can get those records unless they voluntarily give them to you, right? 

Mr. GARRISON. In these type facilities, that is correct. 

Mr. STUPAK. Dr. Sundlof, I have been asking this question for 2 

years and the answer has always been no. Go back to 2007, Peter 

Pan, you mentioned in your testimony here today, did you ever get 

those records for Peter Pan from ConAgra? 

Dr. SUNDLOF. I don’t know the answer to that. I will ask Mike 

Chappell if he knows. 

Mr. STUPAK. So 2 years and you don’t have the records from 2007 

and yet you continue to say you don’t need subpoena power. Don’t 

you think you subpoena power? 

Dr. SUNDLOF. Again, I don’t know whether or not we do have the 

records, sir. 

Mr. STUPAK. I have just been handed a report. Ohio officials now 

have linked a woman’s death to nationwide salmonella outbreak, so 

I guess we are now up to nine deaths and growing. 

Let me ask you this, Dr. Sundlof. Go to tab 11 there, which is 

FDA’s amended 483 report from January inspection. I would like 

to know about each of these violations. Should they be caught in 

a Good Manufacturing Practices inspection, and if you could do a 

yes or no, like observation number three on page five, this is about 

the temperature being not recorded. I mentioned in October six 

times it wasn’t recorded, November 2008, 24 days you never recorded the temperature, in December and January, nothing was recorded. Should that have been caught by inspection, a GMP inspection? 

Dr. SUNDLOF. Yes. 

Mr. STUPAK. All right. How about the pallets being three feet, observation number four, three feet from the finished product, and 

water stains running down in the cooling unit fans in the cooler. 

Should that have been observed by GMP inspection? 

Dr. SUNDLOF. I am going to have to ask Mike Chappell. 

Mr. STUPAK. Mr. Chappell, should that have been caught, water 

stains, with the GMP? 

Mr. CHAPPELL. Certainly one of the things that we do during inspection is look for environmental situations and a water stain is 

indication of a previously—— 

Mr. STUPAK. In observation number five, plant is not constructed 

in such a manner to allow ceilings to be kept in good repair. Should 

that have been caught in a GMP inspection? 

Mr. CHAPPELL. One of the things that we look for to see the general condition of the building, and there are certain things that we 

121 

look for, and if the building is properly constructed, it is easy to 

repair those, and if not, it is not. 

Mr. STUPAK. So that is yes then, they should have caught that 

in the GMP? 

Mr. CHAPPELL. Yes. 

Mr. STUPAK. OK. How about observation number six, design of 

equipment and utensils failed to preclude adulterated food with 

contaminants, specifically felt material is present on the final roller 

at the discharge. This material cannot be adequately cleaned or 

sanitized. Should that have been caught in a GMP inspection? 

Mr. CHAPPELL. If indeed that particular equipment was in place 

and in use at that time, that would be an—— 

Mr. STUPAK. That would be a yes then. OK. How about number 

seven, proper precautions to protect food and food contact surfaces 

from contamination with microorganisms cannot be taken because 

of deficiency in plant construction and design. So that would be 

there all the time. So that should have been caught by GMP, would 

it not? 

Mr. CHAPPELL. I think plant design is certainly one of the things 

that we would look at, especially at it relates to product flow and 

segregation. 

Mr. STUPAK. So that is a yes. How about number eight, specifically the sink located in the peanut butter room is used interchangeably as a point for cleaning hands and utensil tools and for 

washing out mops. That is not Good Manufacturing Practice, is it? 

Mr. CHAPPELL. It is not, but again, though, if indeed the investigator was there at a time it was not being used for both things, 

they might not necessarily have pointed that out. 

Mr. STUPAK. Right, but a sink shouldn’t be in the final product 

area anyway, should it? Because that is water again, isn’t it? 

Mr. CHAPPELL. Yes. 

Mr. STUPAK. OK. How about number 10, besides the dead and 

live roaches, let me ask you this. The bumper pads were inadequate, openings of six inches or more were observed along sides 

and tops of trailers. These trailers contained raw and roasted products, can be left backed up for 7 to 5 days leaving openings in the 

plant. Is that GMP? Is that Good Manufacturing Practice? 

Mr. CHAPPELL. That should have been observed, yes. 

Mr. STUPAK. These violations I have just listed here, all six or 

seven of them, all should have been caught in a normal GMP inspection. Then why weren’t they in the prior inspections? 

Mr. CHAPPELL. The prior inspection the FDA conducted was 

2001, so I think it depends on the conditions at the time—— 

Mr. STUPAK. Well, there was a GMP inspection, there was an inspection for cause on the metal shavings, but some of these are just 

structural. You can see water stains, things like that. That should 

have been caught, should it not? 

Mr. CHAPPELL. It certainly should be observed during the inspection. 

Mr. STUPAK. All right. I guess my time is up. Mr. Deal? 

Mr. DEAL. Thank you. First of all, let me clarify some things that 

I think may have been confused here. First of all, peanuts are not 

an inherently dangerous product. In fact, they are inherently safe. 

Some of us still eat them raw. Isn’t that correct? 

122 

Dr. SUNDLOF. Peanuts, because they lack water, do not support 

the growth of bacteria. What we have seen in the ConAgra case 

and in the recent case with PCA is that once salmonella is introduced into these peanut products, it doesn’t die, it just stays there, 

and then when it becomes ingested, then the bacteria is able to reproduce and cause disease. 

Mr. DEAL. But that is further in the process. Inherently they are 

a safe product unless you get the occasion for something like the 

Chinese organic and there you are talking about something in the 

organic area where the fertilizer, it contains salmonella in many instances and that is not the traditional method and not the traditional peanut product that comes to these plants. Am I correct? 

Dr. SUNDLOF. Just let say, you know, peanuts are grown in the 

dirt and in the dirt there are lots and lots of bacteria and salmonella can certainly be one of those. Generally the peanut processors require a roasting step—— 

Mr. DEAL. And that is the kill cycle? 

Dr. SUNDLOF. That is the kill cycle. 

Mr. DEAL. So whatever might have been there, even though they 

are not inherently dangerous, a proper kill cycle would supposedly 

eliminate that? 

Dr. SUNDLOF. That is correct. 

Mr. DEAL. And that is why the temperatures of the roasters, etc., 

are critical pieces of information? 

Dr. SUNDLOF. Yes. 

Mr. DEAL. All right. Once you get through the kill cycle, then it 

should not have salmonella in the peanut? 

Dr. SUNDLOF. Right, and that is when the Good Manufacturing 

Practices have to make sure that salmonella is not reintroduced 

after the roasting process? 

Mr. DEAL. And that is the reason you can get inconsistent samples one day versus the next day. Presumably if you get a bad sample and a bad report that the lab reports back to the manufacturer, 

their presumption, and I think anybody’s commonsense presumption is that they not only would destroy the product that is bad but 

also that they would take the corrective action in cleaning up the 

facility, doing the other good management practices that would 

have caused the bad sample to occur. Am I not correct, Dr. Cowart? 

Ms. COWART. Yes, sir. That insurance, yes, sir. 

Mr. DEAL. So it is not then inconceivable or totally within reason 

that you might get a bad sample, somebody gets the results, they 

clean it up, they don’t get a bad sample the next time somebody 

comes by or the next time an inspection takes place. But I think 

the thing we all are focusing on is the kinds of things that will be 

able to prevent the bad actors from coming along. We have a bad 

actor here. He did not respond in a way that would be a normal 

response that everybody had reasons to expect they would respond. 

So I guess the thing we are trying to do is to come up with ways 

and methods whereby we can try to prevent the bad actor from 

being able to slip through the holes, and that would be including 

maybe reporting of internal testing to outside agencies such as the 

State department of agriculture or perhaps even the FDA, the 

mandatory keeping of internal records that would be required to be 

disclosed to the inspectors when they come by so that they would 

123 

know whether or not there had been periods where the kill cycle 

was not operating properly or they would know if they had gotten 

a bad test result back. I think those are the objectives that all of 

us have in mind. Is that not the general format, Dr. Sundlof, that 

we should be approaching this from? 

Dr. SUNDLOF. Certainly I think we need to have systems in place 

that are, number one, preventive, and number two, alert us early 

on when there is a problem. 

Mr. DEAL. And I think we all agree with that, and the question 

is, how do we achieve that goal, and since we are in the middle of 

a vote, I am going to conclude, but let me conclude by having 

thanks to all of you for your participation here. You have enlightened us and we do appreciate your attendance at this hearing. 

Thank you, Mr. Chairman. 

Mr. STUPAK. Thank you. 

Mr. Braley, any questions? 

Mr. BRALEY. Yes, thank you. 

Dr. Cowart, I would like to ask you about a document known as 

a certificate of analysis. As succinctly as possible, tell us what a 

certificate of analysis is. 

Ms. COWART. A certificate of analysis for our laboratory is the 

final results that we have obtained through our testing program 

that is issued to the client for the sample they submitted. 

Mr. BRALEY. And what does a company do with a certificate of 

analysis? 

Ms. COWART. With a certificate of analysis, they would look at 

their sample description and understand where that came from, 

and based on the results they need to take action, depending on the 

positive or negative results they get. 

Mr. BRALEY. And let me just show you why what we are talking 

about is so important. This is a list of the 1,900 product recalls at 

the FDA as of February 10, 2009. So when you issue a certificate 

of analysis, you are issuing a certification from your company to be 

relied upon, which has legal consequences. Isn’t that correct? 

Ms. COWART. I think for the company, it is their responsibility 

to do with it what they need to do so it is our result on the sample, 

yes, sir. 

Mr. BRALEY. And you have a contractual obligation to make a 

good-faith effort to perform that test to the best of your abilities because you know they are relying on your analysis for their business 

purposes and their regulatory compliance? 

Ms. COWART. When we issued our certificate of analysis, yes, sir, 

we believe they are relying on us to do that. 

Mr. BRALEY. So I would like you to take a look at a certificate 

generated by your company, JLA, which is at tab 51, page 1, and 

we have got it up on the monitor so you can follow along. In this 

certificate of analysis, your company confirmed the product from 

Peanut Corporation of America tested positive for salmonella, and 

you can see the lot number is 8168–ABCD and it is dated June 23, 

2008. Is that correct? 

Ms. COWART. Yes, sir. 

Mr. BRALEY. Mr. Deibel, let me show you another certificate of 

analysis on the same tab, 51, page 3. This is your private lab’s 

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analysis of the same lot number on the same date but your result 

shows that salmonella is negative. Is that correct? 

Mr. DEIBEL. That is correct. 

Mr. BRALEY. So just to understand, PCA sent two samples from 

the same lot to two private labs, JLA found salmonella and Deibel 

did not, so let us see what PCA did. PCA generated its own certificate of analysis. This is in the same tab, 51, on page 2, and PCA’s 

report shows that its product tested negative for salmonella. This 

is a certificate of analysis that PCA prepared for its customers, correct? You will have to answer affirmatively. 

Mr. DEIBEL. Based on what we are looking at, yes. 

Mr. BRALEY. Dr. Sundlof, what is FDA’s position on this? Isn’t 

it true, Doctor, that is illegal for a company to report on a certificate of analysis a negative salmonella report when it knows that 

there is another lab test that shows a positive result? 

Dr. SUNDLOF. I cannot speak to the legality of that. That certificate of analysis is between the laboratory and the company. Certainly, you know, if we find that they did introduce contaminated 

food into the marketplace, then they are in violation of the Food, 

Drug and Cosmetic Act. 

Mr. BRALEY. Well, are you saying that you don’t know or that it 

doesn’t apply in this context whether that would be illegal for a 

company to do? 

Dr. SUNDLOF. I think that is part of the criminal investigation 

and I can’t expand on that. 

Mr. BRALEY. Well, based on everything we have heard today, 

wouldn’t you agree that if that is not in an illegal practice, it certainly should be? 

Dr. SUNDLOF. Certainly if they were supplying false information 

to the FDA, that would certainly be an illegal practice. 

Mr. BRALEY. Well, and we have heard testimony here that if any 

lot result tests positive, that takes precedent over any comparative 

negative test result, correct? 

Dr. SUNDLOF. That is not written anywhere in the law or the regulations but it is common knowledge within the industry that you 

can’t test your way to negative. 

Mr. BRALEY. So if it is common knowledge within the industry, 

isn’t it true that it would make sense to have that also be applicable in the statute and the regs? 

Dr. SUNDLOF. We would be happy to work with that. 

Mr. BRALEY. And can you tell us how can this practice be allowed, because it is not just egregious, it is really fraudulent to the 

American people, isn’t it, the American consumers who purchase 

these products? 

Dr. SUNDLOF. If they are purchasing food that is purported to be 

something that it is not, absolutely. 

Mr. BRALEY. Thank you. 

Mr. STUPAK. Mr. Walden has a question. 

Mr. WALDEN. Well, Mr. Chairman, I know we have to get to the 

floor for a vote. I do have a couple of questions I would like to be 

able to submit in written form to the panel for your written response. Unfortunately, we have run out of time, but I would concur 

with my colleagues and thank you for your participation today. It 

has been helpful in our efforts, and obviously we have got some 

125 

changes to make in the Federal Government to protect the food 

supply for all Americans, and we are going to do that, so thank 

you. Thank you, Mr. Chairman. 

Mr. STUPAK. And that concludes all questioning. I know there 

are many other questions members have. I want to thank all of our 

witnesses for coming today and for your testimony. 

The committee rules provide that members have 10 days to submit additional questions for the record. I ask unanimous consent 

that the contents of our document binder be entered in to the 

record provided that the committee staff may redact any information as business proprietary, relates to privacy concerns or is a law 

enforcement-sensitive matter. Without objection, documents will be 

entered in the record. 

That concludes our hearing. This meeting of the subcommittee is 

adjourned. Thank you all again. 

[Whereupon, at 2:17 p.m., the subcommittee was adjourned.] 

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