[Senate Hearing 111-231]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-231
 
                   EXAMINATION OF FEDERAL FOOD SAFETY
                        OVERSIGHT IN THE WAKE OF
                         PEANUT PRODUCTS RECALL

=======================================================================



                                HEARING

                               before the

                       COMMITTEE ON AGRICULTURE,
                        NUTRITION, AND FORESTRY

                          UNITED STATES SENATE


                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION


                               __________

                            FEBRUARY 5, 2009

                               __________

                       Printed for the use of the
           Committee on Agriculture, Nutrition, and Forestry


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




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           COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY



                       TOM HARKIN, Iowa, Chairman

PATRICK J. LEAHY, Vermont            SAXBY CHAMBLISS, Georgia
KENT CONRAD, North Dakota            RICHARD G. LUGAR, Indiana
MAX BAUCUS, Montana                  THAD COCHRAN, Mississippi
BLANCHE L. LINCOLN, Arkansas         MITCH McCONNELL, Kentucky
DEBBIE A. STABENOW, Michigan         PAT ROBERTS, Kansas
E. BENJAMIN NELSON, Nebraska         MIKE JOHANNS, Nebraska
SHERROD BROWN, Ohio                  CHARLES E. GRASSLEY, Iowa
ROBERT P. CASEY, Jr., Pennsylvania   JOHN THUNE, South Dakota
AMY KLOBUCHAR, Minnesota
KIRSTEN GILLIBRAND, New York
MICHAEL BENNET, Colorado

                Mark Halverson, Majority Staff Director

                    Jessica L. Williams, Chief Clerk

            Martha Scott Poindexter, Minority Staff Director

                 Vernie Hubert, Minority Chief Counsel

                                  (ii)


                            C O N T E N T S

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                                                                   Page

Hearing(s):

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

                              ----------                              

                       Thursday, February 5, 2009
                    STATEMENTS PRESENTED BY SENATORS

Harkin, Hon. Tom, U.S. Senator from the State of Iowa, Chairman, 
  Committee on Agriculture, Nutrition and Forestry...............     1
Chambliss, Hon. Saxby, U.S. Senator from the State of Georgia....     2
Klobuchar, Hon. Amy, U.S. Senator from the State of Minnesota....    15

                                Panel I

Khan, Ali S., Rear Admiral, M.D., Assistant Surgeon General and 
  Deputy Director of the National Center for Zoonotic, Vector-
  Borne, and Enteric Diseases, Centers for Disease Control and 
  Prevention, Atlanta, Georgia...................................     7
Sundlof, Stephen, M.D., Director, Center for Food Safety and 
  Applied Nutrition, U.S. Food and Drug Administration, 
  Rockville, Maryland; accompanied by Michael Chappell, Acting 
  Associate Commissioner for Regulatory Affairs, U.S. Food and 
  Drug Administration............................................     4

                                Panel II

Dewaal, Caroline Smith, Director, Program on Food Safety, Center 
  for Science in the Public Interest, Washington, DC.............    28
Hubbard, William, Former Senior Associate Commissioner for 
  Policy, Planning, and Legislation, U.S. Food and Drug 
  Administration, Chapel Hill, North Carolina....................    30
Meunier, Gabrielle, Mother of Affected Child, South Burlington, 
  Vermont........................................................    26
                              ----------                              

                                APPENDIX

Prepared Statements:
    Dewaal, Caroline Smith.......................................    48
    Hubbard, William.............................................    59
    Khan, Ali S..................................................    74
    Meunier, Gabrielle...........................................    85
    Sundlof, Stephen.............................................    88
Document(s) Submitted for the Record:
    American Frozen Food Institute, prepared statement...........   100
    Grocery Manufacturers Association, National Association of 
      Manufacturers, National Confectioners Association, National 
      Fisheries Institute, National Restaurant Association, 
      Produce Marketing Association, Snack Food Association, 
      prepared statement.........................................   104
Question and Answer:
Harkin, Tom:
    Written questions for FDA....................................   108
Casey, Robert P., Jr.:
    Written questions for Stephen Sundlof, Ali S. Khan, William 
      Hubbard and Caroline Smith DeWaal..........................   109
Grassley, Charles E.:
    Written questions for Stephen Sundlof and William Hubbard....   110
Stabenow, Debbie A.:
    Written questions for William Hubbard, Stephen Sundlof and 
      Caroline Smith DeWaal......................................   111
Dewaal, Caroline Smith:
    Written response to questions from Hon. Debbie Stabenow......   113
    Written response to questions from Hon. Robert P. Casey, Jr..   115
Hubbard, William:
    Written response to questions from Hon. Charles E. Grassley..   117
    Written response to questions from Hon. Debbie Stabenow......   117
    Written response to questions from Hon. Robert P. Casey, Jr..   120
Khan, Ali S.:
    Written response to questions from Hon. Robert P. Casey, Jr..   123
Food and Drug Administration:
    Written response to questions from Hon. Tom Harkin...........   126
    Written response to questions from Hon. Charles E. Grassley..   128
    Written response to questions from Hon. Debbie Stabenow......   129
    Written response to questions from Hon. Robert P. Casey, Jr..   130



                   EXAMINATION OF FEDERAL FOOD SAFETY



                       OVERSIGHT IN THE WAKE OF



                         PEANUT PRODUCTS RECALL

                              ----------                              


                       Thursday, February 5, 2009

                                       U.S. Senate,
         Committee on Agriculture, Nutrition, and Forestry,
                                                     Washington, DC
    The committee met, pursuant to notice, at 10:04 a.m., in 
room 216, Hart Senate Office Building, Hon. Tom Harkin, 
Chairman of the committee, presiding.
    Present or submitting a statement: Senators Harkin, Leahy, 
Casey, Klobuchar, Chambliss, and Johanns.

 STATEMENT OF HON. TOM HARKIN, U.S. SENATOR FROM THE STATE OF 
    IOWA, CHAIRMAN, COMMITTEE ON AGRICULTURE, NUTRITION AND 
                            FORESTRY

    Chairman Harkin. The Senate Committee on Agriculture, 
Nutrition, and Forestry will come to order.
    Good morning, and I welcome everyone to this hearing. I 
hope you will forgive me, but I will skip the niceties and get 
right to the point. I am nothing short of outraged at the 
increasing number of outbreaks of foodborne illnesses in our 
country. Everything from spinach and lettuce and peppers to 
beef products and now peanut products has been implicated. 
Within the last year, we had the biggest recall ever under USDA 
jurisdiction. In the last month, with the recall of peanut 
products from the Peanut Corporation of America, we have had 
one of the largest recalls ever under FDA jurisdiction.
    To say that food safety in this country is a patchwork 
system is just giving it too much credit. Food safety in 
America has too often become a hit or miss gamble. That is 
truly frightening. When Americans can't count on the safety of 
basic items, like peanut butter that goes into our kids' 
sandwiches that they take to school--look at a jar of peanut 
butter. I mean, what could be more ubiquitous? I mean, everyone 
has this on their shelf. I do at home. I still have peanut 
butter and jelly sandwiches, and it is good for you. Peanuts 
are good for you. It is a healthy food. And when we can't even 
depend on that, that peanut butter that we put in our kids' 
sandwiches that they take to school, that that is not safe, 
then we have to ask, what is?
    It has almost come back to the point where before we had 
truth in packaging, it was always buyer beware. We are almost 
to that point now in food where it is eater beware. Beware of 
what you eat. You are on your own.
    The Centers for Disease Control and Prevention tells us 
there are 76 million cases of foodborne illness annually in the 
U.S., resulting in 325,000 hospitalizations and 5,000 deaths. 
That is not my figure, that is the Centers for Disease Control 
and Prevention. This is intolerable in the United States of 
America.
    Now, reducing the instances of foodborne illness in this 
country means examining every step in the food safety process. 
Our systems for tracing tainted products and removing them from 
commerce must be stronger, better coordinated, faster, and more 
efficient. Regardless of the level of contamination, we need to 
be able to identify the source accurately and promptly and act 
quickly.
    However, as in all of health care, prevention of the 
illness is the key. Prevention is much less costly than the 
treatment. So we must focus on getting the food safety done 
right in the first place, before the pathogens get into the 
food and they need to be recalled.
    Bear in mind this is not only a health issue, it is also an 
economic issue. It is inevitable that demand for the food crop 
that is involved in the outbreak will fall sharply. During a 
recall, retailers lose business. Processors lose customers. 
And, as we all know and as I am sure our Ranking Member, 
Senator Chambliss, knows all too well, farmers suffer, as well. 
Entire communities can face economic devastation, as I think we 
will hear about this small community in Georgia.
    We have got to come up with a better, smarter approach to 
food safety. We have got to make the investments both in better 
systems and in putting more inspectors on the ground. It is 
about the integrity of our food supply. It is about the health 
and wellness of our people and the protection and safety now of 
our children who eat peanut butter. Who would have thought, 
peanut butter?
    So our goal this morning is to explore what went wrong. 
What do we need to do to get things right? This is under the 
jurisdiction of our committee and we intend to pursue it.
    Now, we have a distinguished panel of witnesses. I look 
forward to your best counsel on how we can do a better job of 
preventing outbreaks. I am not an expert in this. I am not a 
veterinarian. I am not a doctor. I am not an epidemiologist. 
But something has got to be done and we need the best 
information possible on what to do, first on prevention, and 
second, when outbreaks happen, how can we do a better job of 
stopping them early before they spread.
    So with that, I will now turn to my friend, my Ranking 
Member, Senator Chambliss.

STATEMENT OF HON. SAXBY CHAMBLISS, U.S. SENATOR FROM THE STATE 
                           OF GEORGIA

    Senator Chambliss. Thank you very much, Mr. Chairman. Last 
year, it was tomatoes. Today, it is peanuts. Next week, it may 
be some seafood. But you are exactly right. We have a system 
that is flawed and a system that in this particular instance 
has once again failed consumers across America.
    I am pleased to see you with this jar of peanut butter 
here, because coming from a State that grows almost 50 percent 
of the peanuts that are grown in America, we want to make sure 
that every consumer that walks into the store and buys a peanut 
product can have the comfort of knowing that product is safe, 
and frankly, it is not just with peanuts, but it is with every 
product on the shelf. We are seeing now that has been called 
into question.
    It just so happens this jar of peanut butter is totally 
safe. Under the testimony that you will hear today, the issue 
of salmonella that has caused serious problems around the 
country came from one isolated facility and went into a number 
of products around the country. But a jar of peanut butter like 
this or Peter Pan or whatever it may be is totally safe.
    Not only do we have a failure in the mechanisms of 
detecting foodborne illnesses, but we have a flawed system of 
educating the public about products, as well. So I am very 
pleased that in today's hearing, it is an important step to 
help members of this committee examine the various roles of 
Federal and State officials and the responsibilities of private 
food manufacturers in ensuring that our food supply is safe.
    Clearly, there are lessons to be learned from this latest 
salmonella outbreak from a peanut processing plant in my State 
of Georgia. While I understand that today's government 
witnesses may be limited in some responses due to the ongoing 
criminal investigation, I do hope that we can identify how to 
better coordinate the Federal, State, local, and private sector 
response to a food safety situation. Our goal is to put in 
place the most effective tools to protect the American consumer 
and to put confidence in the marketplace where it is lacking 
today.
    An effective public-private sector partnership is critical 
to ensuring a safe food supply. The private sector has the 
responsibility to follow Federal guidelines and ensure the 
safety of their products. The Federal and State governments 
have the responsibility to oversee these efforts and take 
corrective actions when necessary. We need to quickly identify 
gaps in the system and act swiftly to correct them.
    The current salmonella outbreak could prove to be one of 
the largest in our history. The fact that a contaminated 
product was ultimately used as an ingredient in hundreds of 
other products has challenged our food safety system to a new 
degree.
    I appreciate the FDA and CDC witnesses for sharing their 
knowledge and initial reactions to this situation with us today 
and I look forward to continued collaboration with their 
agencies as we move forward to develop and implement 
improvements to protect our food supply.
    I want to extend a special thank you to Ms. Meunier for 
appearing before the committee today to share her family's 
personal experience. I read her testimony and I applaud her 
efforts to bring tangible recommendations to Congress. They are 
practical and they are common-sensical, things that simply make 
almost too much sense that the bureaucracy has a difficult time 
comprehending.
    I look forward to working with the pertinent Federal and 
State agencies, private industry, the scientific community, and 
citizens as we strive to achieve the common goal of maintaining 
a safe, affordable, and nutritious food supply that all 
Americans can enjoy, and I thank you, Mr. Chairman, and look 
forward to the testimony today.
    Chairman Harkin. Thank you very much, Senator Chambliss.
    I just want to, again, before we introduce our panel here, 
I just want again to reassure parents across the country that 
the peanut butter that they buy in these jars, whether it is 
Skippy, Jiffy, or what was that other one you said?
    Senator Chambliss. Peter Pan.
    Chairman Harkin. Peter Pan, of course, all those are safe. 
These are safe, and if anyone disagrees with me, say so, but I 
believe that is factual. You don't have to worry about it. I 
will even eat my own peanut butter sandwich while I listen to 
the witnesses just to show you that I don't have any fear of 
eating peanut butter.
    [Laughter.]
    Chairman Harkin. Let me now turn to our first panel. We 
have Dr. Stephen Sundlof from the FDA Center for Food Safety 
and Applied Nutrition. He was appointed Director of this Center 
January 7 of 2008. He provides the executive leadership to the 
Center's development and implementation of programs and 
policies relative to the composition, quality, safety, and 
labeling of foods, food color and additives, dietary 
supplements, and cosmetics. In the 14 years preceding this, Dr. 
Sundlof served as Director of FDA's Center for Veterinary 
Medicine. Before that, he was a professor at the University of 
Florida College of Veterinary Medicine.
    We have Rear Admiral Ali S. Khan, M.D., currently Assistant 
Surgeon General and Deputy Director of the National Center for 
Zoonotic, Vector-borne, and Enteric Diseases from the Centers 
for Disease Control and Prevention. He joined the CDC and the 
U.S. Public Health Service Commissioned Corps in 1991 and has 
been with them ever since.
    And we have--I am sorry, you will have to introduce Mr. 
Chappell. I don't have a bio on Mr. Chappell.
    First, I have all your testimonies. They will be made a 
part of the record in their entirety. I would ask if you would 
sum it up in about 5 minutes or so, maybe seven, but around 
that timeframe so we can get into a discussion with all of you, 
and I will start with Dr. Sundlof and then we will go to Rear 
Admiral Khan.
    Dr. Sundlof, welcome and please proceed.

 STATEMENT OF STEPHEN SUNDLOF, M.D., DIRECTOR, CENTER FOR FOOD 
       SAFETY AND APPLIED NUTRITION, U.S. FOOD AND DRUG 
  ADMINISTRATION, ROCKVILLE, MARYLAND; ACCOMPANIED BY MICHAEL 
CHAPPELL, ACTING ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS, 
               U.S. FOOD AND DRUG ADMINISTRATION

    Mr. Sundlof. Thank you, Mr. Chairman and Senator Chambliss. 
As you indicated, I am Dr. Stephen Sundlof, the Director of the 
Center for Food Safety and Applied Nutrition at the U.S. Food 
and Drug Administration, which is part of the Department of 
Health and Human Services, and I am accompanied today by 
Michael Chappell. Michael is FDA's Acting Associate 
Commissioner for Regulatory Affairs. FDA appreciates the 
opportunity to discuss the ongoing investigation of the 
foodborne outbreak associated with Salmonella Typhimurium, 
which has been found in peanut products produced by the Peanut 
Corporation of America, and I will refer to that as PCA from 
here on out.
    In a typical traceback process employed by the FDA and our 
partners at the Centers for Disease Control and Prevention or 
CDC, they notify FDA when it identifies the possible foods 
associated with a foodborne illness outbreak through its 
epidemiological investigation, and it is at that point that the 
FDA starts its investigation to identify the source of 
contamination. In the current case, FDA started its tracing 
process before the CDC notified us of the strong 
epidemiological link, both to help inform the epidemiological 
study and to shorten the time period required to get the 
potentially contaminated food off of the market.
    Since December of 2008, FDA has collaborated with CDC and 
the Food Safety Inspection Service of USDA and public health 
officials in various States to investigate a multi-State 
outbreak of human infections due to Salmonella Typhimurium. 
Peanut butter was first identified as one of several possible 
sources in mid-December.
    On January 7 and 8, based on conversations with the CDC, 
Food Safety Inspection Service, and the Minnesota Department of 
Health about preliminary epidemiological data, FDA decided to 
begin to investigate institutional food service sources of 
peanut butter rather than to wait for more conclusive data. And 
on January 8, based on the preliminary information from CDC's 
multi-State case control study, FDA made its initial contact 
with the King Nut Company in Ohio. King Nut distributes peanut 
butter manufactured by PCA to institutional facilities, not 
supermarkets or retail, but to institutional facilities, food 
service industries, and private-label food companies in several 
States.
    On January 9, FDA initiated an inspection of the PCA 
manufacturing plant in Blakely, Georgia. As part of its 
epidemiological investigation, the Minnesota Department of 
Health tested an open five-pound container of King Nut peanut 
butter obtained at a nursing home where three patients were 
sickened by the outbreak strain of Salmonella Typhimurium. And 
by January 10, Minnesota officials had found that the peanut 
butter contained the same strain of Salmonella Typhimurium 
associated with the illness linked to the outbreak. However, 
because it was an open container which could have been 
contaminated by someone or something else in the environment, 
these results did not conclusively confirm that the Blakely 
plant was the source.
    So FDA expanded the testing of unopened containers of the 
same brand of peanut butter, and on January 19, testing by the 
State of Connecticut Health Department of an unopened container 
of King Nut peanut butter showed that it contained the same 
strain of Salmonella Typhimurium associated with the illnesses 
linked to the outbreak. The fact that Salmonella Typhimurium 
was confirmed in an unopened container of peanut butter 
indicated that the peanut butter was contaminated when it left 
the plant in Blakely, Georgia.
    As I noted earlier, FDA had already initiated the 
inspection of PCA's Blakely plant on January 9. FDA completed 
its inspection on January 27 and FDA's environmental sampling 
of the plant found two salmonella strains, but neither of these 
were the outbreak strain. We are confident, however, that based 
on the investigations by the States, CDC, and the FDA, that the 
Blakely plant is the source of contamination related to the 
Salmonella Typhimurium outbreak. Further, FDA's review of the 
firm's testing records 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. PCA's most recent recall 
began on January 28, 2009, when the firm issued an expanded 
voluntary recall of all peanut products processed in its 
Blakely facilities since January 1 of 2007, including the 
following products: Dry and oil-roasted peanuts, granulated 
peanuts, peanut meal, peanut butter, and peanut paste. Many 
companies that received peanuts and peanut products 
manufactured by the PCA's Blakely facility have, in turn, 
conducted voluntary recalls.
    FDA is continuing to work with the purchasers of PCA's 
peanut and peanut products to identify affected products and 
facilitate their removal from the market. FDA initiated 
inspections of the direct consignees of PCA and King Nut and 
continues to follow the distribution points for products. FDA 
and State officials have contacted hundreds of firms throughout 
the entire distribution chain that may have purchased or 
further distributed PCA products.
    We would like to emphasize that the major national brands 
of peanut butter in jars found in grocery stores are not 
affected by the recall, as Senator Chambliss has already 
pointed out. Further, FDA has no evidence suggesting that the 
contamination originated in any manufacturing facility other 
than the PCA Blakely plant. That facility is no longer 
operating at this time.
    FDA has established a webpage to provide constantly updated 
information on the contamination and recall. It includes a 
searchable data base to assist consumers in quickly identifying 
recalled products. FDA encourages consumers to check this 
website to determine which products have been recalled and 
continue to check that as new recalls appear.
    In closing, let me assure you that the FDA is working hard 
to ensure the safety of the food supply in collaboration with 
its Federal, State, local, and international food safety 
partners and with industry, consumers, and academia. In the 
current outbreak, FDA acted expeditiously to determine the 
source of the contamination and to identify affected products 
to facilitate the removal from the marketplace.
    Although the Salmonella Typhimurium foodborne illness 
outbreak underscores the challenges that we face, the American 
food supply continues to be among the safest in the world. Food 
safety is a priority for the new administration.
    Please be aware that FDA is actively conducting both 
criminal and regulatory investigations related to his matter. 
To protect the integrity of these ongoing investigations and 
any related actions that might be pursued in the future, FDA 
must necessarily keep certain information confidential. 
Further, it is premature for FDA to draw conclusions about its 
preliminary observations or how FDA's legal authorities might 
apply to those observations. But that said, we will do our best 
to respond to any questions that you may have.
    Thank you again for the opportunity to discuss these 
important public health matters.
    [The prepared statement of Dr. Sundlof can be found on page 
88 in the appendix.]
    Chairman Harkin. Thank you very much, Dr. Sundlof.
    Now we will turn to Admiral Khan. Admiral Khan, welcome to 
the committee and please proceed.

STATEMENT OF REAR ADMIRAL ALI S. KHAN, M.D., ASSISTANT SURGEON 
    GENERAL AND DEPUTY DIRECTOR OF THE NATIONAL CENTER FOR 
   ZOONOTIC, VECTOR-BORNE, AND ENTERIC DISEASES, CENTERS FOR 
        DISEASE CONTROL AND PREVENTION, ATLANTA, GEORGIA

    Admiral Khan. Good morning, Chairman Harkin, and thank you 
for the invitation to address the committee today. I am Ali 
Khan, an Assistant Surgeon General and Deputy Director of the 
National Center for Zoonotic, Vector-borne, and Enteric 
Diseases at CDC.
    As the nation's prevention agency, CDC leads the Federal 
efforts to gather data on and investigate foodborne illnesses 
and outbreaks and to monitor the effectiveness of prevention 
and control efforts. CDC depends on our critical partnership 
with State and local public health departments and our very 
close collaborative relationship with FDA and USDA to get this 
work done.
    Salmonella is a group of bacteria that is widespread in the 
intestines of reptiles, birds, and mammals, and it is the most 
common cause of bacterial foodborne disease in the United 
States. The current outbreak is caused by the most common type 
of salmonella, Salmonella Typhimurium, which causes about 15 to 
20 outbreaks each year.
    On November 10 of 2008, CDC began to monitor a small, 
highly dispersed, multi-State cluster of 13 cases of Salmonella 
Typhimurium with an unusual laboratory pulse fingerprint, 
something that we call the PFGE fingerprint, and those 13 
isolates were reported by 12 States to PulseNet, and PulseNet 
is our national network of public health and food regulatory 
agencies that is used to detect foodborne disease outbreaks.
    On November 25, the cluster had increased to 35 isolates 
reported from 16 States and was subject to increasing 
investigation. Beginning in early December, this cluster was 
combined with another laboratory cluster of 27 cases in 17 
States that was shown also to be the same salmonella using 
better laboratory tools. These combined clusters were then 
joined for an intense investigation and communication during 
December into early January that usually starts with numerous 
interviews to suggest the likely food item or common exposures 
followed by these detailed epidemiological studies of these 
food items.
    The early epidemiologic evidence suggested an association 
with peanut butter served in institutions as a possible 
explanation for at least a part of the outbreak. Salmonella was 
isolated from an open container of King Nut peanut butter in 
Minnesota, and the outbreak strain of Salmonella Typhimurium 
was isolated from a previously, as you heard, unopened five-
pound container of King Nut creamy peanut butter in 
Connecticut.
    However, ongoing interviews indicated that many cases 
actually did not eat peanut butter in an institution but had 
eaten various other peanut-containing products. To better 
determine the association of illness with other peanut butter-
containing products, a second large study was conducted by CDC 
in collaboration again with its partners between January 17 and 
19 to assess these exposures in these non-institutional 
settings, and preliminary analysis suggested looking at people 
who were ill compared to people who weren't ill showed that 
they had actually eaten specific brands of prepackaged peanut 
butter crackers, and these both brands of peanut butter 
crackers were made at one plant which is known to receive 
peanuts from PCA.
    As of yesterday, we have had 575 persons from 43 States and 
one person from Canada who have been infected with this 
outbreak strain. We have had reported onset of illness starting 
from September 1 of last year until January 22 of this year. A 
total of 127 people have required hospitalization, and the 
infection may have tragically contributed to the death of eight 
persons.
    The epidemiologic, laboratory, and traceback findings from 
this continuing investigation indicate that peanut butter and 
peanut paste produced at PCA are the source of this outbreak. 
More specifically, the outbreak was caused by contaminated 
peanut butter used in institutions and by peanut butter and 
peanut paste used as ingredients in food products. So we call 
this an ingredient-driven outbreak in which a contaminated 
ingredient can affect many different products that are 
distributed through various channels and consumed in various 
settings.
    The outbreak appears to be slowing, but we will not be able 
to know that for sure at this point. Because of the natural 
time lapse in reporting, it will be two to 3 weeks after it 
ends before we can actually tell you the end of the outbreak.
    In conclusion, this event illustrates how a large and 
widespread outbreak can occur from distribution of a single 
item into hundreds of foods. It also highlights the continued 
need for robust disease and detection response systems at all 
levels, local, State, and Federal to really enjoy that prompt 
recognition, response, and investigation into outbreaks.
    CDC will also continue its efforts to focus on research, 
education, and training that will assist with strategies to 
prevent foodborne illness before they happen, incorporate the 
food industry into our prevention, response, and information 
sharing activities, and really help bolster the State public 
health infrastructure to effectively and promptly identify and 
respond to these outbreaks. We are prepared to continue to work 
with regulatory authorities, State and local partners, food and 
environmental microbiologist scientists, and the food industry 
to find long-term solutions to prevent foodborne disease and 
limit those that do occur.
    Thank you again for the invitation to testify before you 
today. I will be happy to answer any questions you may have.
    [The prepared statement of Ali S. Khan can be found on page 
74 in the appendix.]
    Chairman Harkin. Well, thank you very much, Dr. Khan and 
Dr. Sundlof. We will open our first round of questions here.
    Dr. Sundlof, news reports indicate that FDA is increasingly 
relying on contracts with State agencies to carry out the 
responsibilities of FDA, such as inspection of facilities like 
those of the Peanut Corporation of America. If I have it 
correct, according to the Washington Post, FDA last inspected 
that Blakely, Georgia plant in 2001, that is, last inspected it 
before January of this year. Is that correct?
    Mr. Sundlof. The plant was inspected by FDA inspectors in 
2001, but FDA does have contracts with the State of Georgia to 
conduct investigations on our behalf and those investigations 
did occur in 2007 and 2008.
    Chairman Harkin. OK. As I understand it, the FDA contracted 
inspections to the Georgia Department of Agriculture in 2006, 
correct?
    Mr. Sundlof. I believe that is correct, yes.
    Chairman Harkin. So what happened between 2001 and 2006, 
can I assume it just wasn't inspected by anyone?
    Mr. Sundlof. I don't think that is the case. The State of 
Georgia was in that plant frequently, at least twice a year 
every year. They were inspecting under their own authority and 
not under contract from the FDA. We formalized those contracts, 
I believe, with them in 2006.
    Chairman Harkin. But the reports show that the Georgia 
Department of Agriculture found problems at the plant in 2006, 
2007, and 2008. Did the FDA know at that time about this? Did 
they learn about this from the Georgia Department of 
Agriculture? Three times, 2006, 2007, and 2008, the Georgia 
Department of Agriculture found problems there. Was this 
reported to the FDA?
    Mr. Sundlof. The problems were reported to the FDA in 2007 
and 2008 under the inspections that were conducted under FDA 
contract.
    Chairman Harkin. So again, if, in fact, the Department of 
Agriculture of Georgia found these problems, reported them to 
the FDA, did the FDA take any action at that point in time?
    Mr. Sundlof. The State of Georgia investigating or 
inspecting under our authority found infractions where they 
discussed these with the firm and the firm took corrective 
actions. So when the report goes back to the FDA from the State 
of Georgia, we make a determination of whether or not those 
violations were corrected, and if they were, then we would 
schedule them for a regular re-inspection.
    Chairman Harkin. Let me get this clear. When the Department 
of Agriculture of the State of Georgia found these problems, 
they reported them to the FDA. Did the FDA--is that a 
requirement under that contract?
    Mr. Sundlof. Under the contract, they are required to 
report.
    Chairman Harkin. To report that. But then what 
communications took place between FDA and the Department of 
Agriculture of Georgia regarding those problems?
    Mr. Sundlof. Well, the Department of Agriculture--in fact, 
if I can ask Mike----
    Chairman Harkin. Did they actually--because I understand 
they found things like mold and they found roaches and they 
found different things like that. That is from what I read. I 
can't say that.
    Mr. Sundlof. Those were things that we found, that the FDA 
found in its inspection last month.
    Chairman Harkin. Oh.
    Mr. Sundlof. There were some sanitary and maintenance 
issues that the State of Georgia uncovered, and maybe Mike 
Chappell can talk to that since he is in charge of that part of 
the FDA.
    Chairman Harkin. Can you enlighten us, Mr. Chappell? After 
the Department of Agriculture of the State of Georgia reported 
this to the FDA, what happened?
    Mr. Chappell. Thank you, Mr. Chairman. These reports based 
on State contract inspections are evaluated by a supervisor in 
the district that is responsible for that State. In reviewing 
that report, the supervisor felt that the State's inspectional 
findings and then the firm's corrections based on the State 
inspections were consistent with observations and corrections 
that FDA would have made.
    If there had been an issue there where the supervisor felt 
that these were significant unresolved issues, they would have 
entered a dialog with the State inspection group to talk about 
those. The inspection reports that they got under State 
contract, those issues during the review of that were 
considered to be somewhat resolved and the State was working 
with this company over several inspections to resolve ongoing 
issues.
    Chairman Harkin. So if this committee requested to see 
those reports that came from the Department of Agriculture of 
Georgia to the FDA and FDA's response to that, that would be on 
file, right?
    Mr. Chappell. Yes, sir.
    Chairman Harkin. We could take a look at those, right?
    Mr. Chappell. They are on file with FDA, yes, sir.
    Chairman Harkin. And I would like to request that you make 
those available to this committee.
    Mr. Chappell. Yes, sir.
    Chairman Harkin. I ask this because just yesterday, media 
reports showed that a Texas plant that also contracted with the 
Peanut Corporation of America may have gone uninspected for as 
many as 4 years by the Texas Department of Agriculture. Have 
you read that? Do you have any knowledge of that?
    Mr. Sundlof. Yes. Those food firms are required to be 
licensed by the State of Texas, OK. This does not involve FDA, 
but they are required to be licensed and apparently this firm 
was unlicensed in that State. It was known to the FDA. I think 
we had it in our registry. The FDA has a registry of all food 
firms, whether it is foreign or domestic, that came out of the 
2002 Bioterrorism Act. They were in our data base and we knew 
of that company.
    Chairman Harkin. Are you telling me that FDA knew that 
there was this plant in Texas that was not being inspected by 
the Texas Department of Agriculture? Is that a fact, that they 
were not inspected by the Department of Agriculture?
    Mr. Sundlof. My understanding is that they were not 
inspected by the Texas Department of Agriculture because they 
were unaware, based on their data base, that the firm was 
manufacturing.
    Chairman Harkin. And shipping interstate?
    Mr. Sundlof. And shipping interstate.
    Chairman Harkin. Should I be alarmed about that? I mean, 
how many more of these instances are there in the United States 
where you may have a plant that is manufacturing, shipping 
interstate, and you don't know about them and the State doesn't 
know about them? Or you know about them, but you didn't inspect 
them, and the State doesn't even know they exist, should I be 
concerned that there are dozens of these in the United States?
    Mr. Sundlof. Each State deals with these issues a little 
bit differently. We maintain, again, an inventory of all the 
food firms and we try and get to those food firms based on a 
lot of different criteria--whether or not they are producing a 
high-risk product, whether or not they have a past inspection 
history that indicates that they are likely to be out of 
compliance--a number of different factors as to how we choose 
specific food firms to inspect. But it is based largely on our 
identification of them as being a high, medium, or low risk.
    Chairman Harkin. I know I have gone over. I just have one 
more thing I want to tie down here. Regarding the salmonella 
testing at the Blakely plant, is it correct that there were on 
five occasions positive tests for salmonella at the Blakely 
plant in 2007? The months, I believe, were June and July.
    Mr. Sundlof. Over the history from 2007, we know that on 12 
different occasions, they had tested positive for salmonella.
    Chairman Harkin. Twelve occasions? Five in 2007?
    Mr. Sundlof. I believe that is correct, yes, sir.
    Chairman Harkin. Well, what happened then?
    Mr. Sundlof. Well, as far as we know, and again, this is 
still part of the ongoing investigation, they shipped product. 
They retested the product at some point and received a negative 
finding. So they originally had a positive finding for 
salmonella. They sent another sample to a laboratory, an 
independent laboratory for analysis, and they came back 
negative and they shipped the product.
    Chairman Harkin. Right there, now they did not have to 
report to the FDA the findings of salmonella.
    Mr. Sundlof. That is correct.
    Chairman Harkin. But you could go under the Bioterrorism 
Act and request later on, as you did, those reports, and that 
is how you found that out just recently, right?
    Mr. Sundlof. Right. We started to uncover some of that 
information before we actually invoked the bioterrorism 
provisions for records, but certainly that helped.
    And let me just say in regard to that, under the 
Bioterrorism Act, FDA cannot require records unless there is a 
reasonable belief that the product is adulterated and could 
result in serious adverse health effects. That is the criteria 
by which the FDA can require, demand records. So for the most 
part, in a routine inspection, those records may not be 
revealed to us because the company is not required to give us 
that information.
    Chairman Harkin. Well, it seems to me that is one gaping 
loophole, that a company that does its own testing finds 
salmonella, does not even have to report that to the FDA.
    Mr. Sundlof. Yes, and let me just say----
    Chairman Harkin. To me, that is a big loophole. That one, 
at least, ought to be closed.
    Mr. Sundlof. There is some partial relief on that, and that 
is the Food and Drug Administration Amendments Act, I believe, 
of 2007, in which there is now the requirement that FDA develop 
a reportable food registry in which companies would be required 
to notify us in the event that they thought they had a problem. 
But in that particular case, the food would have had to have 
already been distributed. So the finding--if a company found 
salmonella in its product and did not ship product, it would 
not have to report to us. So there are still some additional 
loopholes, as you indicated.
    Chairman Harkin. Thank you very much, Dr. Sundlof.
    Senator Chambliss?
    Senator Chambliss. Thank you, Mr. Chairman.
    Dr. Sundlof, let me see if I can get a time line based upon 
your testimony and previous discussion with you. The first time 
that FDA became aware that PCA was manufacturing peanut butter 
at the Blakely facility was in 2001, is that correct?
    Mr. Sundlof. In 2001, PCA was not manufacturing peanut 
butter. They were listed as a peanut roaster and blancher. That 
was their operation at that time.
    Senator Chambliss. All right. And the only reason FDA knew 
that there was any peanut processing going on at that Blakely 
facility was when some peanuts were attempted to be shipped 
into Canada and there were metal fragments found in those 
peanuts, is that correct?
    Mr. Sundlof. No. We knew that the plant was producing 
peanut butter in 2007 because the State of Georgia----
    Senator Chambliss. No, I am talking about 2001.
    Mr. Sundlof. Oh.
    Senator Chambliss. In 2001 is when you discovered that 
there was any processing of peanut products going on at the 
Blakely facility, and the reason you discovered it then is 
because product was attempted to be shipped into Canada and 
there were metal fragments found in that processed product, 
isn't that correct?
    Mr. Sundlof. I don't believe that is correct. I think the 
metal fragments were found much later, in 2006, was it?
    Mr. Chappell. Two-thousand-and-eight.
    Mr. Sundlof. It was 2008 that they shipped the peanuts to 
Canada and Canada rejected those because of metal fragments.
    Senator Chambliss. All right. Well, let us go back then. 
Tell me when you found out that there were peanut products 
being processed at that Blakely facility.
    Mr. Sundlof. We knew in 2001 that they were roasting and 
blanching peanuts. That is what they reported to us. It was not 
until 2007, when the plant was inspected under FDA contract by 
the Department of Agriculture in Georgia, that we recognized 
that they were now--in addition to producing just the peanuts, 
they were producing peanut butter and peanut paste and peanut 
meal.
    Senator Chambliss. And how did you become aware in 2001 
that they were processing a peanut product there?
    Mr. Sundlof. They are registered in our data base of all 
food firms and they registered themselves as a roaster/
blancher.
    Senator Chambliss. OK. Do you know whether or not that is 
the point in time that they started producing products?
    Mr. Sundlof. We do not know that.
    Senator Chambliss. OK. Then you had your first inspection, 
I believe you said 2006, 2007? What was that date?
    Mr. Sundlof. Mike, maybe you can help me out on the dates.
    Mr. Chappell. Yes. The first inspection of the Blakely 
facility was in 2001, and as Dr. Sundlof said, that was the 
time that they were blanching and roasting peanuts. They were 
not manufacturing peanut butter at that time.
    Senator Chambliss. All right. And the Georgia Department of 
Agriculture conducted inspections from that point until what 
additional point in time before FDA went back into the plant?
    Mr. Chappell. Actually, the State of Georgia conducted 
several inspections, as Dr. Sundlof mentioned, between 2001 and 
as late as 2008. They do not keep their records, my 
understanding is, more than 3 years, so we know we have some 
instances where they inspected it four times in 2006.
    Senator Chambliss. All right, but from an FDA perspective, 
when was the next time that FDA went into that plant, either 
under contract or on your own?
    Mr. Chappell. The two inspections prior to the one in 
January were conducted by the State of Georgia under contract 
with FDA.
    Senator Chambliss. And what is the date of that?
    Mr. Chappell. Well, 2007 and 2008, as I recall.
    Senator Chambliss. OK.
    Mr. Chappell. I can get you the exact dates on that later 
if you----
    Senator Chambliss. All right. And when you ultimately 
discovered that the Blakely facility was the source of this 
outbreak, you immediately went to the plant to do what? What 
was your intention of going to the plant?
    Mr. Sundlof. Before we had absolute conclusive evidence but 
we were fairly certain that those products were involved, we 
went to the plant--I believe that was on the 9th of January--
and we discussed the findings with the company. I would ask 
Mike to talk about that interaction with the company.
    Mr. Chappell. The inspection was initiated because of 
information that we obtained--and I would like to back up a 
little bit and talk about how we got there. When it was obvious 
that King Nut was possibly implicated in this outbreak, we knew 
that King Nut corporate headquarters was in Ohio, and when we 
visited the Ohio facility, we learned that the King Nut brand 
peanut butter was actually manufactured exclusively in the 
Georgia plant, and it was based on that and the emerging data 
that suggested we need to be looking at peanut butter as a 
possible vector for this outbreak. That is when we initiated 
the inspection in the Blakely facility.
    Senator Chambliss. And at the time you inspected the 
facility in January, did you have any authority to ask for all 
of the inspection records that the plant had done on its own?
    Mr. Chappell. We routinely ask for records when we are 
following up these types of suspect links to foodborne 
illnesses. The firm was not required to provide us records 
based on our notice of inspection and initiating the 
inspection.
    Senator Chambliss. Did they voluntarily give you those 
records?
    Mr. Chappell. There were requests made for records, and 
during the course of the inspection, we did receive records on 
multiple occasions.
    Senator Chambliss. And is that when you discovered that 
there had been 12 tests done in that plant that showed positive 
for salmonella in 2007 and 2008?
    Mr. Chappell. Actually, this is a series of events that 
occurred. When we originally started the inspection, we were 
focused on King Nut brand peanut butter, asked specifically for 
records relating to King Nut. As the investigation continued, 
and that included the epidemiological investigation and then 
reports coming in of samples of other products--an example 
would be crackers--that implicated other products, we asked for 
additional and other records. We did that on multiple occasions 
during the course of the inspection as this began to expand to 
other products other than King Nut peanut butter.
    Senator Chambliss. Well, I am still not clear about your 
answer to the question, though. When did you discover that 
there had been 12 previous positive findings of salmonella?
    Mr. Chappell. We discovered that as we got these records 
over time. So by the end of the inspection, we had all 12 
incidences.
    Senator Chambliss. All right. What period of time did that 
cover then?
    Mr. Chappell. The inspection started on January the 9th and 
ended on January the 27th.
    Senator Chambliss. OK. So within that period of time, and 
you can't tell us exactly when you found out that there were 
positive findings for salmonella, but somewhere during that 
period of time?
    Mr. Chappell. It was on multiple days during that 
inspection.
    Senator Chambliss. All right. Did anybody ever ask the 
company, have you ever found salmonella and can you give us the 
dates of when you found it and the test results showing 
positive results on salmonella?
    Mr. Chappell. Early on in the inspection, we asked, had 
there ever been a positive salmonella finding for King Nut 
peanut butter and the firm provided us that information. As we 
moved forward and implicated other products and made other 
requests for other types of products they produced, the firm 
did provide some records.
    Senator Chambliss. So when you asked that question to start 
with, they didn't give you all their test results showing 
positive for salmonella?
    Mr. Chappell. No, sir.
    Senator Chambliss. Did the State of Georgia have this 
information relative to those tests?
    Mr. Chappell. I couldn't answer that, Senator.
    Senator Chambliss. Well, I mean, you are under contract 
with them. Do you not know whether or not they had that, as 
your contractee?
    Mr. Chappell. They did not provide that to us as part of 
the contracting inspections.
    Senator Chambliss. But you don't know whether or not they 
had that information?
    Mr. Chappell. No, sir, I do not know that.
    Senator Chambliss. Mr. Chairman, I am going to stop to let 
other folks ask questions and I will come back in the next 
round.
    Chairman Harkin. We will do another round.
    I will ask Senator Klobuchar both for an opening statement 
and for questions since a lot of this did focus in Minnesota.

STATEMENT OF HON. AMY KLOBUCHAR, U.S. SENATOR FROM THE STATE OF 
                           MINNESOTA

    Senator Klobuchar. OK. Well, thank you very much, Chairman 
Harkin, and thank you to our witnesses.
    This did focus on Minnesota in one tragic way and then in 
one positive way. The outbreak most affected my State in that 
three people have died, the most of any single State. One 
victim was Shirley Mae Almer of Perham, a small town on 
Northern Minnesota. At age 72, she was still a strong lady, but 
on December 21, she died and she died because every morning she 
liked to have toast with peanut butter.
    I believe it is shameful that a death like this could 
happen in America. All of this has obviously renewed public 
concerns about the safety of America's food supply, as well as 
the Federal Government's capacity to ensure the safety of the 
food that we consume. I am glad that the Department of Justice 
has opened a criminal investigation.
    On Monday, I sent a letter to President Obama urging him to 
nominate a new permanent FDA Commissioner as soon as possible 
to begin the process of reforming the Federal Government's food 
safety system. A number of positive reforms have been 
discussed, including greater coordination and streamlining of 
responsibilities among Federal agencies, more resources, added 
authority for mandatory recalls, which I believe touches on 
some of the things we have talked about this morning, more 
effective prevention of foodborne illnesses, and better 
coordination between State, local, and Federal, which also has 
come up already this morning.
    The other way that this crisis has touched our State is in 
a positive way in that it was the Minnesota Department of 
Health, not a Federal agency, that discovered the source of the 
current salmonella outbreak, and I want to commend our 
Minnesota food safety team for their work. They are on the 
front line in the fight against unsafe food. I believe their 
work should be looked at as a model.
    This is not the first time that the Minnesota Department of 
Health has found the needle in the haystack. Last summer, there 
was another serious salmonella outbreak that caused hundreds of 
Americans to get sick. Initially, the FDA thought it was 
tomatoes, but after six Minnesotans got sick from eating in a 
local restaurant, the Minnesota Department of Health was able 
to pinpoint jalapeno relish as the source. They contacted the 
CDC and helped track down the culprit. It was the jalapeno 
peppers imported from Mexico.
    I admire the hard work of our Health Department, but all of 
this happened because of a failure, the failure of our 
government to prevent unsafe food from entering the food chain.
    The question that I have of you, Dr. Sundlof, I listened 
with some interest and sort of shock that we now--it seems to 
me just based on the questions with Senator Harkin, that a 
company can repeatedly have a salmonella problem in their plant 
and the FDA never knows about it, is that correct?
    Mr. Sundlof. Thank you, Senator. Yes, that is correct. 
Again, the law that has recently passed, the Food and Drug 
Administration Amendments Act, does give us some additional 
authority to require that information if they have already 
shipped the product from their facility.
    Senator Klobuchar. So you have to have this shipping, which 
obviously creates a much more hazardous possibility, before you 
can even find out. Do you think this is something the FDA 
should know about, when you have repeated outbreaks of 
salmonella at a plant?
    Mr. Sundlof. We would like to have as much information as 
we possibly can get, yes.
    Senator Klobuchar. But right now, you don't have that 
information. And if the States have it, if the States find out 
about it--he was talking about Texas and these things--then you 
automatically get it?
    Mr. Sundlof. If they report it to us. The States do a lot 
of inspections on their own. We don't necessarily have access 
to that----
    Senator Klobuchar. So they are not automatically required 
to give you the information?
    Mr. Sundlof. They are not.
    Senator Klobuchar. So we have a situation where plants can 
have repeated salmonella outbreaks, or salmonella discoveries. 
They are not required to tell you. And then you can have State 
departments of food and drug inspection that find this out and 
they are not required to tell you, is that correct?
    Mr. Sundlof. I think that is correct.
    Senator Klobuchar. Yet we have seen from these deaths 
across the country that this isn't a single State issue. To me, 
it seems like it is a national issue.
    Mr. Sundlof. That is correct.
    Senator Klobuchar. All right. In April 2008, a Canadian 
distributor refused a shipment of peanuts from the Peanut 
Corporation because the peanuts had metal fragments in them. 
Are you aware of that?
    Mr. Sundlof. Yes.
    Senator Klobuchar. And the products were then returned to 
the U.S. and destroyed after the FDA found the peanuts to be 
unacceptable. Now, I don't know about you. If I found out my 
13-year-old daughter, who, by the way, loves peanuts, loves 
peanut butter, if she was eating metal in her peanuts, I would 
expect the government to do something about this. So what 
happened? Was there any further action taken?
    Mr. Sundlof. We required the company to destroy that lot of 
product.
    Senator Klobuchar. But you didn't have the company--is 
there some allowance in the tools that you have now to then 
have the company on some special watch list where you are 
looking at repeat offenses and are concerned that there may be 
a problem here?
    Mr. Sundlof. Again, the plant was inspected on numerous 
occasions, several times by the State of Georgia, and again, 
some of those were under our contract. So Georgia was very 
vigilant in making sure that they were going to that plant on a 
very frequent basis.
    Senator Klobuchar. So Georgia went, but you guys didn't 
really know they were going?
    Mr. Chappell. Senator, when this lot was attempted to be 
reentered into the United States and several attempts to 
recondition it failed, we did ask the State of Georgia, under 
contract with us, to cover that during their next inspection, 
and they did that and they evaluated the firm's ability to 
monitor and control metal fragments.
    Senator Klobuchar. OK.
    Mr. Chappell. And they reported back to us that their 
assessment was that the firm had in place processes to ensure 
that they didn't get metal fragments in their product. That is 
not a real common occurrence. It typically is the result of 
some kind of machinery malfunctioning. It is not typically 
something that goes on over a long term.
    Senator Klobuchar. And back to the salmonella issue, how 
much do you think this is going on in food processing plants 
and in different plants across the country where salmonella is 
found? If we find out there were, what, 12--is that what it 
was, Dr. Sundlof, 12 instances of this----
    Mr. Sundlof. Yes.
    Senator Klobuchar [continuing]. At this plant, is this 
unique or is this happening all over America?
    Mr. Sundlof. Well, this practice has been universally 
condemned and the industry certainly understands that this is 
not an appropriate way of ensuring quality of your product. 
Since the incident back in 2007 with Peter Pan peanut butter in 
the ConAgra plant, there has been a great amount of effort both 
on the part of the peanut industry and the FDA to inspect these 
plants and make sure that they are not engaging in practices 
that would lead to the salmonella contamination.
    There have been seminars and symposiums. There have been 
articles written that specifically talk about the fallacy of 
trying to test products into what we call compliance. In other 
words, once you find a positive sample of salmonella, it is 
well known within the industry that that product needs to be 
destroyed at that point in time because continued sampling to 
obtain a different result is fraught with problems. We know 
this.
    So I don't believe this is a problem that is rampant 
throughout the industry. I believe this is one individual 
company.
    Senator Klobuchar. But do you acknowledge that there are 
problems with the information flow here to the Federal 
agencies?
    Mr. Sundlof. We would like to have more information, there 
is no question. I think you can say that about all the products 
we regulate. The more information that we have, the quicker we 
can take the proper actions to prevent illness.
    Senator Klobuchar. Do you think there are problems in that 
we have these voluntary recalls? Do you think that is working 
for the people of this country? That will be my last question. 
I see you going like this, Senator Harkin.
    [Laughter.]
    Mr. Sundlof. Regarding voluntary recall, FDA has a number 
of tools. Right now, as you indicated, we do not have the 
authority to demand recalls. We do have the bully pulpit and we 
use that all the time. I don't think there has ever been a case 
to my knowledge where a company has refused to recall product 
when we have told them in very specific terms that we would be 
taking additional actions, and those additional actions can be 
things like seizure. We can seize the product. We can enjoin 
the company from doing further business----
    Senator Klobuchar. But if you don't have the information, 
you are not going to do that, and that was the problem, I 
think, for Ms. Almer and her family, so all right.
    Mr. Sundlof. Thank you.
    Senator Klobuchar. Thank you.
    Chairman Harkin. Thank you very much, Senator Klobuchar.
    Senator Leahy?
    Senator Leahy. You know, I listened to the question of 
cooperation and it sounds good. Obviously, there wasn't a heck 
of a lot of cooperation here. One of the witnesses we are going 
to hear from later is Gabrielle Meunier of South Burlington. 
She lives there in Vermont. Her 7-year-old son, Christopher, 
became severely ill. He was actually hospitalized for nearly a 
week with salmonella. He got that from peanut crackers.
    Now, all this voluntary cooperation didn't tell her 
anything to say, take that out of her pantry. She is a mother, 
like all mothers. If she had gotten any kind of a warning that 
this is a danger, none of that stuff would have been fed to her 
children. We don't have young children in our household, but 
our home in Vermont and our home down here, we constantly have 
grandchildren coming in and my wife and I scour the lists of 
any kind of recalls from your Department or anywhere else all 
the time.
    We are going to have Caroline Smith DeWaal testify here 
today. She is a native Vermonter, a graduate of the University 
of Vermont. Her mother still lives there. Her father, the late 
Dr. Durwood Smith, was Chairman of the Pharmacology Department 
at the Medical School at the University of Vermont, a highly 
respected person.
    I mention all this because as I sit here and listen, we 
hear, well, we want cooperation. Maybe we will get cooperation. 
For one thing, in this particular case, at least based on the 
news reports I have heard, this was a company that should have 
shut everything down immediately--immediately. I think, Admiral 
Khan, you would agree with that. At the first sign of 
salmonella, you go back and clean everything out.
    Wearing another hat, as Chairman of the Senate Judiciary 
Committee, I have written asking for criminal prosecutions in 
this case. If a company thinks, well, I will wait for an 
inspection, maybe there will be an inspection, maybe there 
won't--I know, Doctor, that your Department is shorthanded. 
There is no conceivable way you could inspect everywhere. But 
if they think, well, if we get caught, maybe something, maybe a 
recall, maybe we will get a fine, it is a cost of doing 
business. Well, in this case, the cost has been people who have 
lost their lives. It has certainly been an enormous cost to 
companies who may have totally safe products, but they have had 
to recall them and now their products are tainted, at least in 
the public's view.
    I would like to see some people go to jail. I don't really 
care what kind of a fine is put on a company that ignored this 
because I don't think that really bothers people. It is like 
the horrible things that have happened in the financial 
markets. You give them a fine. It is the cost of doing 
business. When somebody thinks they are going to go to jail if 
they don't report something, report it adequately and clean it 
up, that is an entirely different thing. It is not corporate 
headquarters that is going to pay a fine. It is the person who 
discovered it who is thinking, I might spend the next few years 
as a guest of the State in a small cell with bars on the window 
eating food that I am not too sure of. Then you are going to 
get them.
    What kind of steps are going to be taken in the next few 
months to make sure these kind of things don't happen again, or 
do we have to assume they will happen again in some other area?
    Mr. Sundlof. Well----
    Senator Leahy. And you understand, Doctor, this is not 
directed at you. I am just so frustrated. I am looking at these 
people in Vermont. They do everything they are supposed to do 
and still their child ends up 6 days in the hospital with the 
anguish of the parents wondering, is the child going to live?
    Mr. Sundlof. Thank you, Senator, and there is a criminal 
investigation currently ongoing in this case. We don't know how 
that will turn out, but certainly it is a concern that we had.
    We had our first wake-up call in 2007 with peanut butter 
causing salmonellosis on a nationwide basis, and at that time, 
we took what we thought were prudent measures in, first of all, 
inspecting peanut plants, peanut butter plants around the 
country to make sure that they were practicing good, safe 
production processes. We held seminars. We discussed a lot of 
this with the peanut industry. We thought, and we still do 
think that they have made changes to their process and they 
have educated their members to make sure that this doesn't 
happen.
    It was just as disappointing to us to find out that after 
all of this additional work that had gone on, that a single 
company could let this happen. After the recall is completed, 
we will be looking back and see about what went wrong, what 
could we do in the future to prevent this from ever happening 
again, I can assure you.
    Senator Leahy. My time is up, Mr. Chairman. No, that is OK. 
I am hoping to get to the next panel before I have to leave.
    Chairman Harkin. All right, good.
    Well, we do want to get to the next panel, but I do want to 
ask Admiral Khan from CDC a question. It seems to me that, 
well, as I said earlier, we want to get to the prevention. We 
want to stop this before it happens. But if something happens 
and there is an outbreak, the question has to do with 
coordination and discovering things more quickly. Now, this has 
been going on for 3 months--three months. It seems that 
PulseNet has helped to coordinate all this, but they need to be 
discovered more quickly.
    Besides the solution to add more money to the budget, what 
other authorities does CDC need to more quickly diagnose these 
outbreaks? As I understand it, PulseNet is triggered at a 
certain level of illnesses. I don't know what that is. What 
threshold causes an activation of this system? Should it be 
lower than what it is right now? How can we get to these more 
quickly than 3 months?
    Admiral Khan. Thank you, Senator, for that question. I do 
want to make a comment. I am a pediatrician and Christopher's 
story really resonates with me. With these diseases, 
unfortunately, it is the very young, the very elderly, and the 
immunocompromised who get infected, and again, there were eight 
tragic deaths associated with this illness. So prevention 
really is key, and that is a shared public health mission 
between CDC and FDA and industry. We all have the same mission. 
We want to really limit these illnesses, and if we can't limit 
them, find them as early as possible.
    Now, the outbreak originally started in September, so it 
took two months of cases before PulseNet was triggered, a 
blinking light that we have some lab cases that are associated. 
And December was when sort of the alarm bells go off. There is 
too much of this, so an extensive, intensive investigation 
conducted in collaboration with FDA and our State and local 
partners. And 1 month of investigation that got us eventually 
to what we thought the agent was likely to be, and then the 
timely investigation by FDA that went into the plant to figure 
out what was going on.
    Now, this is actually quite typical for what happens with 
foodborne outbreaks. This time line that I have just laid out 
to you over a couple of months is very typical of what is going 
on with our outbreak responses currently. And as you just 
mentioned, there are a number of opportunities to really 
shorten this time line to where we have cases identified a lot 
quicker and we have a response a lot faster.
    And to make that happen, we need a couple of things. So the 
first thing is we need new tools at the local, State, and 
national level to investigate these outbreaks. So I mentioned 
originally how PulseNet had two separate patterns, that with 
new technology, we recognized it was one, the same outbreak. So 
we need new laboratory tools to make that happen.
    We need new information tools to do the investigation. We 
need tools such as computer-assisted telephone interviews to do 
these investigations. We need new ways to standardize, analyze, 
bring information together in real time, so right away, to 
understand what is going on.
    So there are a number of tools we need. We need new tools 
to look at new diseases, such as C. difficile and other 
diseases that we want to look at. So we need new tools.
    The second thing we need is better investment at the State 
and local level to actually make these diagnoses quickly, do 
the PulseNet testing very quickly, do the interviews very 
quickly, and then come to a determination that we think this is 
an implicated exposure and then hand that off to FDA as fast as 
possible so they can do their timely response.
    So more tools, new tools at multiple levels, and the 
investment in public health at the State and local level. I am 
a big fan of CDC. I work at CDC. CDC is vital. But the bottom 
line is public health occurs at the State and local, Tribal and 
Territorial levels. That is where thousands of public health 
professionals every day are making these diagnoses, 
investigating these outbreaks, and we need to support them.
    Chairman Harkin. Now, you just told me something I didn't 
know. Obviously, this has been over a 5-month period of time 
now. You say it was started in September?
    Admiral Khan. Yes, sir, September 1st, I believe, was the 
first onset case, sir.
    Chairman Harkin. So a lot of people are getting sick and 
perhaps even dying as this thing goes on and on and on. So you 
are telling me in order to make this more efficient and 
quicker, we need new lab tools, more tools, more personnel?
    Admiral Khan. Definitely. I met last week with the State 
and Territorial epidemiologists. These are your leaders at the 
State level, the public health leaders, and basically they want 
boots on the ground. They need people who can help look at--so 
we are just describing for you one PulseNet cluster. There are 
over 150 PulseNet clusters.
    Any given large State health department, such as yours, 
would be investigating during the winter maybe 20 or 25 
clusters at any given time. So they need the boots on the 
ground to analyze those specimens, not have to wait weeks 
potentially to test them. They need boots on the ground to say, 
this is a cluster. They need tools to look at those clusters.
    And they need boots on the ground to make all the calls and 
follow up with these people and say, what did you eat, in a 
timely manner instead of four or 5 weeks, months after the 
fact, say, what did you eat back in September? You would like 
to be as close to the illness as possible to ask those 
questions while the memory is fresh.
    Chairman Harkin. Admiral, you are saying what I have been 
saying for a long time. We have been saying the same thing, and 
that is we have for far too long ignored our public health 
sector in this country. I think we have just assumed that, 
well, things are OK. We just don't have to do anything.
    But the fact that our--and we really haven't done anything 
about good manufacturing practices under FDA since 1986. Think 
about the changes that have taken place in our food 
manufacturing and distribution system in the last 20- some 
years. You have something manufactured at a plant someplace and 
within 24 hours, it could be in 40 different States. That 
wasn't true 20-some years ago. It is true now.
    So we haven't changed and updated our public health system 
to cope with this new distribution system that we have in the 
United States, both with the manufactured food but also with 
produce that comes into this country that is just distributed 
all over, which we found with the peppers last year and 
tomatoes that Senator Chambliss mentioned.
    So it just seems to me that we have an obligation, I think, 
to the American people to really look at the public health 
structure in this country, the new challenges that we face, and 
come up with the resources that we need to get the boots on the 
ground, as you say, the people that are out there to help 
protect the health and well-being of the public out there.
    That is one thing. I asked you if the threshold should be 
lower on what triggers a PulseNet. Do you have any response to 
that? When I talk about that, people say, well, if you do that, 
then that might lead to too many false starts, false things, 
and that takes a lot of time and consumes a lot of energy and 
money, so I am not certain where that threshold should be.
    Admiral Khan. Sir, there is not a specific threshold. There 
are a number of factors that drive these investigations. So 
there are over 60,000 patterns in PulseNet generated any given 
year, 60,000 patterns, and so as you look at those patterns, 
what happens is they look at the pattern itself, how 
distributed the pattern is into multiple States, how severe the 
disease may be associated with that pattern, how unique the 
pattern is. If it has never been seen before, like this one, 
that says, OK, this is probably more likely to be interesting, 
and whether or not that pattern has previously been associated 
with some other product.
    So there are a number of factors that go into deciding that 
this is a cluster that we need to follow, and then as that 
cluster is followed, there are triggers based on the disease 
that say, OK, we now need an additional level of investigation 
that requires us to call into place OutbreakNet and work with 
all our--more closely with all our State and local 
epidemiologists to really start making the calls.
    Throughout that process, we work very closely with FDA, and 
this was actually a really good example, as a side topic, of 
that closeness occurring back at the end of November-beginning 
of December to make sure that we had a collaborative 
relationship.
    Chairman Harkin. Well, I will stop with this and yield to 
Senator Chambliss here, but it just seems to me here you have 
got an FDA that doesn't require reports to be made to it if 
there is an outbreak of salmonella, as this plant did not have 
to report these things. They don't have really the authority to 
go in and do much, as I understand it, right now. Then you have 
the CDC that basically is understaffed, undermanned, and really 
tracking these outbreaks down in a timely manner. It seems the 
two of them together really does cry out for some kind of 
better coordination, stiffening our laws.
    I think one of the things, we have got to close that 
loophole on requirement of reporting of internal findings of 
pathogens. And then a better coordination between FDA and CDC 
with more support for the Centers for Disease Control and 
Prevention in terms of being able to track things down in a 
more timely manner. Five months, I just think that is way too 
long to bring a closure on this and find out what is causing 
all these illnesses. Surely we can do better than that.
    Admiral Khan. Yes, sir. Surely we can do better than that. 
We actually have excellent coordination and collaboration with 
FDA, and in this specific investigation, FDA was involved in 
the investigation way early in the investigation. We shared 
people between the agencies extremely early in the 
investigation, and we really worked very well on 
communications, which was something that came up after the 
tomato outbreak, to improve our communication strategies. We 
have gone to novel communication strategies together, Twitter, 
our blogs, podcasts, coordinated communications strategy with 
FDA, and FDA set up an excellent searchable website where 
people could quickly go in and figure out what products had 
been recalled.
    Actually, I should best turn it over to FDA to talk about 
some of their coordinated activities, also.
    Chairman Harkin. Well, I have to yield to my Ranking Member 
here. We have to move along right now. I will close it with 
that.
    Senator Chambliss?
    Senator Chambliss. Dr. Sundlof, does FDA have any 
jurisdiction or control over the private labs, such as the one 
or ones that would have done the testing at this PCA plant?
    Chairman Harkin. Good question.
    Mr. Sundlof. I don't believe that we have any direct 
authority to require them to provide the results that they have 
based on a private firm, for instance. We don't have the 
authority to require information that they would consider to be 
proprietary to that firm that they were testing for.
    Senator Chambliss. You don't have the authority to ask them 
for the information, nor is there any requirement that a 
private lab that tests a facility that processes food to be 
shipped in interstate commerce that finds a positive test, 
there is no requirement that they report that to you?
    Mr. Sundlof. Let me correct one thing. We do have the 
authority to ask, and we do ask on almost every occasion. They 
are not required to provide us with that information.
    Senator Chambliss. But that is what I am saying. They don't 
have to give it to you, nor is there any requirement that if 
they find a bacterial infestation in a food product that is 
going into interstate commerce, they don't have to tell you 
about that, do they?
    Mr. Sundlof. I believe that is correct.
    Senator Chambliss. Which is, again, one of those very 
serious loopholes that we need to try to plug.
    Last to you, Dr. Sundlof, the recall of products such as 
found to be contaminated with salmonella in this instance, does 
that have to be voluntary or can you demand that those products 
be recalled?
    Mr. Sundlof. We cannot demand that they be recalled. We 
work with the companies and the company--the recall is the 
responsibility of the company. The FDA does the audit checks to 
make sure that products are actually coming off of the shelves.
    Senator Chambliss. And in this particular instance, it 
seems like every day for about the last two or 3 weeks, we have 
been getting in the media reports that additional products are 
being added to the list. So again, there is no way FDA has any 
control over what products are recalled other than the company 
itself advising the people to whom it sold the product to make 
their own recall of their products, is that correct?
    Mr. Sundlof. That is correct, and it has to go all the way 
down the supply chain, too, so that Kellogg's is recalling 
their peanut butter crackers. It is not just the PCA company.
    Senator Chambliss. Admiral Khan, I, too, am bothered by the 
fact that the first indication of this came on your PulseNet 
the first of September and here it was actually January the 
19th before anything positive was done. November 10, you said 
in the monitoring of the Pulse system there were 16 States that 
showed up on the PulseNet. Now, that is a third of America that 
has all of a sudden developed some sort of illness. I don't 
know whether you knew it was salmonella or not then, but 
obviously you knew there was something going on in a third of 
the States. I don't understand why that didn't trigger more of 
an alarm on the part of the CDC to try to figure out what the 
heck is going on.
    Admiral Khan. Thank you very much, Senator, for that 
question. So the original illnesses occured in September and 
October and the first PulseNet indication that something was 
going on was in November. The initial PulseNet patterns didn't 
come in until early November. So we recognized them very 
quickly.
    But I talk about this as akin to driving while looking 
through your rear-view mirror. It takes 3 weeks for us to 
understand what is going on; and then to understand the impact 
of any decision it takes another 3 weeks in the future to 
understand the impact of those decisions. So based on the way 
our systems work, there is that delay.
    Now, there were actually, as I said, 13 patterns in 12 
States on November 10. We have 60,000 patterns, over 300 to 400 
clusters that are being investigated every year. In the winter, 
25 to 30 clusters at any given time. So based on a number of 
criteria, such as how rare the pattern is, what the agent is, 
the severity of the agent, how widespread that pattern is, 
whether or not it has previously been associated with a food 
item is how we begin that investigation.
    And so the early steps of the investigation were as you 
heard, sir. Then the moment we sort of say, this looks like a 
unique pattern, we then reach out for increased monitoring of 
laboratory patterns to say, please, if you have any Salmonella 
Typhimurium, please type them very quickly. Salmonella 
Typhimurium is not at the top of the list in a State for 
typing. It is more likely diseases that are more severe, such 
as E. coli and listeria that would be likely to be typed. So we 
try to enhance the States to start doing the laboratory 
testing, and many of these clusters just disappear.
    When the cluster doesn't disappear and has started to gain 
momentum, and in this case we were actually able to add it to a 
second cluster, and when those two clusters came together, it 
became very clear that this was a nationwide multi-State 
outbreak, and that triggered the full press with all the State 
epidemiologists saying, what is going on? Let us start 
interviews. Let us do some hypothesis generating. And then it 
takes about a month to sort of figure out what is going on.
    Senator Chambliss. Well, you all have got to figure out 
some way to speed up that process. I don't understand, with 
technology being what it is today. It appears that there is 
that public health network out there. We knew that 16 States 
were involved. I see nothing to indicate that CDC was 
aggressive in notifying public health systems in all 50 States 
that, hey, be on the lookout for this. I see nothing to 
indicate that, as I think has been evidenced by what Dr. 
Sundlof says, that because we have no jurisdiction over these 
private labs, that there is any regulatory requirement that 
private labs notify CDC when salmonella is found. I see nothing 
in your testimony--I am going to be interested to hear from Ms. 
Meunier with respect to her contacts to CDC where she drew a 
blank, but she did find somebody at FDA that was able to look 
at the actual crackers that her child had eaten.
    When you take all of this in concert together, there is a 
huge breakdown in the system here. I don't know whether it is 
stovepipes at CDC and FDA and the Georgia Department of 
Agriculture or what is going on here, but there is a total lack 
of information sharing between all of our food safety 
organizations that we simply have got to fix. I am not blaming 
you guys because you are the messengers here. But it is pretty 
obvious that we have got to make some major changes and we 
can't do it without significant input from you folks.
    So as we move through this and learn a lesson from this, we 
are going to need to get you all back up here to talk about how 
we develop this legislatively or how we instruct you to do so 
from a regulatory standpoint, because, I mean, this was found 
September 1. November 25, when this child ate those crackers, 
this should have been well known to everybody in the public 
health community and it should not have happened.
    Thank you, Mr. Chairman.
    Chairman Harkin. Thank you.
    I see Senator Johanns has rejoined our committee here. I 
was trying to get on to the second panel because of time, but I 
want to be responsible and respect your presence here, Senator, 
I say Mr. Secretary, but Senator Johanns.
    Senator Johanns. Mr. Chairman, I would suggest we go to the 
next panel. I am learning the challenges of three committee 
hearings all at once, so let us go to the second panel and I 
will make sure and review the testimony and the questions. 
Thank you.
    Senator Leahy. Mr. Chairman, I will waive my second round 
of questions because we have gone so far over time.
    Chairman Harkin. Thank you very much.
    This panel is excused. If you could stay around just in 
case something comes up for questions in the second panel, I 
would appreciate it.
    So we will call our second panel, Ms. Gabrielle Meunier 
from South Burlington, Vermont; Ms. Caroline Smith DeWaal, 
Director of the Program on Food Safety for the Center for 
Science in the Public Interest; and Mr. William Hubbard, former 
Senior Associate Commissioner for Policy, Planning, and 
Legislation for the Food and Drug Administration.
    Senator Leahy. Mr. Chairman, I mentioned something earlier 
about Gabrielle Meunier. She does come here from South 
Burlington, Vermont. She is the Controller for Pomerleau Real 
Estate in Burlington. In my family, we know the Pomerleau 
family really well. I should mention I married a Pomerleau, so 
that is why, I should point out the connection.
    But that is not why she is here. She is here because she 
lives in South Burlington with her husband, Darrell, and their 
children and it was 7-year-old Christopher who became so 
severely ill. I think Vermonters throughout the State prayed 
for Christopher's health and have been so aware of what he went 
through after the salmonella poisoning from peanut crackers. He 
survived, thank goodness, so I am glad you are here.
    But no parent should have to go through this. I think the 
case proves the FDA has to be given effective inspection 
oversight and Congress should look at requiring specific 
inspection frequencies for all food plants. We have to work 
from farm to fork to make sure that we improve the safety of 
food in our country.
    Of course, Ms. Smith DeWaal is well known in Vermont. She 
is a native Vermonter, as I mentioned before. Her late father, 
Dr. Durwood Smith, was so highly respected in the Pharmacology 
Department at the Medical School of the University of Vermont. 
I knew him when I was State's Attorney, and I should quickly 
add not because he did anything wrong, but he was very helpful 
to us in a number of areas. Your mother, Sue Smith, still lives 
in Vermont, is that correct?
    Ms. DeWaal. Yes.
    Senator Leahy. Mr. Hubbard, I am afraid I can't make a 
Vermont connection for you, but you are welcome in Vermont 
anytime.
    Thank you, Mr. Chairman.
    Chairman Harkin. He probably spent a nice vacation there 
once sometime.
    All of you, welcome. Your testimonies will be made a part 
of the record in their entirety and I ask you to summarize them 
in five to 7 minutes, if you would be so kind.
    Ms. Meunier, welcome again and please proceed.

STATEMENT OF GABRIELLE MEUNIER, MOTHER OF AFFECTED CHILD, SOUTH 
                      BURLINGTON, VERMONT

    Ms. Meunier. Thank you very much. Thank you, Senator Leahy, 
Chairman Harkin, and the rest of the committee, for this 
opportunity to appear before you today and share the story of 
my son, Christopher, and our experience with the salmonella 
poisoning and the peanut recall that followed.
    On November 25, 2008, my perfectly healthy and robust 7-
year-old son, Christopher, started showing signs of what 
appeared to be the flu. After consulting with our pediatrician, 
we limited his food and made sure he got plenty of fluids. But 
just 2 days later, Christopher's health deteriorated 
dramatically. He became violently ill and was in tremendous 
pain, a pain that no child should ever have to experience, and 
one as a mother I will never forget. How in the world could a 
seemingly perfectly healthy child get so sick in such a short 
amount of time?
    Once the lab results finally came back and he was diagnosed 
with salmonella, the picture became a little clearer. After six 
terrorizing days and sleepless nights in the hospital, filled 
with antibiotics, antifungus drugs, and no food or drink, his 
wrecked little body finally stabilized to a point where he 
could come home.
    Senators I could spend all day long telling you about our 
ordeal and Christopher's terrible experience and the lingering 
questions that we still have about his long-term health, but I 
would rather use my time here today to help enact progress and 
change.
    Some excellent ideas have been proposed for improving our 
food safety system and I would like to add a few of my own. 
Senators, I believe that technology is the key to improving our 
responses to foodborne illnesses at every step along the way.
    First, there should be a national online foodborne illness 
data base registry that should be used as soon as a foodborne 
illness has been diagnosed. Such a tool should be utilized 
immediately when the patient is in the hospital or the doctor's 
office, for the patient to record the foods eaten over the last 
week. This way, the information is still fresh in the victim's 
mind rather than over a week later, on the phone with a 
representative from the State health department for a two-and-
a-half-hour interview.
    In this age of technology, I don't understand why victims 
could not be given access to one another via a secure website 
and a chat room to allow them to talk to one another and 
possibly solve the question of which foods poisoned them. Had I 
had this opportunity to talk to other mothers whose children 
were sick and compare what they had eaten, I have no doubt we 
would have solved this cracker case back in early December.
    Those involved in the outbreak response should never 
underestimate how much the victims crave information. I was 
kept in the dark for way too long throughout this process. At 
one point, I had to insist on learning the specific kind of 
salmonella Christopher had because I was told I didn't need to 
know. Victims must be kept in the loop with real-time 
information and there must be a way to reach all victims by 
phone. An automated phone message system for victims could 
easily be established for disseminating information. After all, 
how many people in this room got text messages from President 
Obama during inauguration weekend? We should have received some 
sort of alert as soon as there was the slightest possibility 
that crackers were suspected as being tainted instead of, by 
chance, in an online article I read.
    When I called the CDC, because I had remaining possibly 
poisonous crackers left in my home, no one would take my call. 
The FDA was willing to help, but the holiday and the 
inauguration came first and it delayed any action. In speaking 
with the FDA, it was made clear to me that the CDC was not 
sharing information about my child's illness. All the agencies 
working on this outbreak should have had access to the same 
data. Technology must be used to share information between all 
the teams and lines of defense working on the outbreak.
    The public needs to be kept informed, perhaps via an alert 
system similar to those for storm warnings. This system could 
also be utilized to update the public when it is safe to eat a 
food. Right now, it is just a guessing game, a game of Russian 
roulette, and we all have to rely upon the media to keep us up 
to date, which is inefficient, at best.
    Next, I believe there should be a unified procedure for the 
genetic identification of food poisoning cases. Labs should be 
regionalized and best practices should be shared. Once 
identification is made and data entered into this registry, 
correlations can be made to determine if there is a pattern 
developing. Victims' information will already be in the 
registry. They are important. So now, swift action can be taken 
immediately.
    After our experience, I believe there should be one team in 
charge at the national level. This team should use technology 
and the registry data base for collecting and disseminating 
their information to all lines of defense. It is crucial that 
our local doctors, the hospitals, the State health departments, 
the CDC, and the FDA all have access to this data base. As the 
system is now, Christopher's doctors had to ask around on their 
own of other local pediatricians if patients had similar 
symptoms. Had there been a national data base that they could 
have referred to, they would have seen perhaps that there were 
clusters or similar symptoms in other States in the United 
States. This information is important for the first lines of 
defense to have. And were we to have a bioterrorist act in 
food, this data would be absolutely invaluable.
    Finally, I believe there needs to be personal 
responsibility in manufacturing and growing foods for 
consumption by the public. The owners of companies must be 
personally responsible for the safety of the foods they sell. 
Inspection records should be made online and made available to 
the general public, and owners should personally attest to the 
safety of their food. Manufacturers must take responsibility 
for all ingredients in their products and there should be a 
transparent process to verify that their suppliers are meeting 
certain standards. Clearly, this did not happen in this case 
and now the government must ensure this will never happen 
again.
    Thank you to the committee for holding this hearing today. 
I would like to close by thanking the staff at the Children's 
Hospital of Vermont. Our family is so thankful that Christopher 
received the best care in the world, and lucky for us, he was a 
big boy to begin with. I shudder to think of the possible 
outcome had he been underweight or sickly to begin, and my 
heart goes out to all the other victims and the families who 
lost their loved ones. Thank you, and I welcome any of your 
questions.
    [The prepared statement of Ms. Meunier can be found on page 
85 in the appendix.]
    Chairman Harkin. Thank you very much, Ms. Meunier. Right to 
the point and I appreciate it very much.
    Ms. Meunier. Thank you, Mr. Chairman.
    Chairman Harkin. We will move to Ms. Caroline Smith DeWaal, 
who has been before our committee before in the past. We 
welcome you again, Caroline. Please proceed.

 STATEMENT OF CAROLINE SMITH DEWAAL, DIRECTOR, PROGRAM ON FOOD 
SAFETY, CENTER FOR SCIENCE IN THE PUBLIC INTEREST, WASHINGTON, 
                               DC

    Ms. DeWaal. Thank you. Thank you very much, Senator Harkin. 
And to just clarify for Senator Leahy, my mother did relocate 
in Michigan a number of years ago to be close to her 
grandchildren, but I grew up there. I spent the first 20 years 
of my life there.
    Senator Leahy. Remind your mother that there is a 
constitutional duty for grandparents to spoil their 
grandchildren.
    Ms. DeWaal. I will.
    Senator Leahy. Thank you. Tell her I said so.
    Ms. DeWaal. Well, thank you so much, and really, it is as 
much for parents and grandparents, I think, that you are 
holding this hearing because it really does impact so many 
Americans when peanut butter becomes the source of one of these 
outbreaks.
    My name is Caroline Smith DeWaal and I have been Director 
of the Center for Food Safety at the Center for Science in the 
Public Interest for many years, working on food safety issues 
really since 1991. In addition to CSPI, we are joined today on 
this testimony with Consumers Union, which endorsed the 
testimony earlier this morning.
    The Peanut Corporation of America outbreak, like countless 
episodes in the previous 2 years, illustrates tremendous gaps, 
many that you have discussed this morning, in our food safety 
system. For example, the company had no food safety operating 
plan and ignored repeated positive salmonella findings. The 
State of Georgia lacked full access to the plant's food safety 
records. The FDA failed to provide adequate oversight of the 
State inspection program and of the plant involved. Finally, 
the penalties available to FDA to prosecute this company don't 
match the culpability of the company.
    Despite its size and scope, this event is neither rare nor 
unexpected. In fact, Congress, many committees, including 
yours, have held nearly 20 hearings in the last 2 years focused 
on failures in FDA's food program linked to everything from 
spinach tainted with E. coli 0157:H7, pet food containing 
ingredients which were intentionally adulterated with melamine, 
and even a previous peanut butter salmonella outbreak.
    Now is the time for Congress to take action to 
fundamentally reform and fully fund our national food safety 
system. Legislation should focus on making the companies 
accountable for food safety while giving the State and Federal 
inspectors better tools to assess the food safety programs and 
the performance of companies.
    The heart of any reform effort lies in prevention, not 
response. Congress should require every food plant regulated by 
FDA to have a food safety plan detailing that it has analyzed 
its operations, identified potential hazards, and is taking 
steps to minimize or prevent contamination. Former Secretary 
Johanns knows that, in fact, that is the system we have for 
meat and poultry today, but it is not similarly applied to FDA-
regulated products.
    Legislation should set specific inspection frequencies for 
all food plants and establish clear auditing parameters when 
States are conducting inspections on behalf of the Federal 
Government. Specific authority should allow inspectors to have 
access to the results of tests conducted by the plant as well 
as all food safety reports that support the written plan. 
Without this check, a company can follow the practices of this 
Georgia peanut company, which instead of fixing its salmonella 
problem, it fixed the tests. Congress needs to strengthen the 
State inspection and surveillance systems by providing 
assistance through training and grants.
    CSPI also believes that giving FDA authority to require 
better ingredient tracing and to order a recall are critical 
tools for responding to future outbreaks. Today, when you see 
notices of the recall, they often mention that it is voluntary, 
and that is true. But this type of language may not compel 
consumers to act with the requisite urgency because consumers 
might think, well, you know, if it were serious, FDA would have 
mandated the recall.
    These are a few of the elements already included in 
legislation before Congress that could have prevented the PCA 
outbreak and the massive recall which is still ongoing. 
President Barack Obama promised us a government that works. 
These new authorities and increased funding will certainly help 
FDA improve. But to deal with the root of the problem, Congress 
and the Obama administration will need to go beyond making a 
few quick fixes. Structural reforms are also essential.
    Although FDA is responsible for the safety of approximately 
80 percent of the food supply, the FDA's Commissioner must 
divide his or her attention among drugs, medical devices, 
foods, and cosmetics. And frankly, food issues frequently fall 
to the bottom of the pile. There is no single food safety 
expert in charge of the policies, the budget, and the 
enforcement staff, and no credible voice communicating to the 
public and the industry what can be done to prevent outbreaks.
    It is time to elevate food monitoring functions within the 
Department of Health and Human Services. With both the public 
and the regulated industries clamoring for change, there is no 
reason to delay. Preventing future outbreaks and recalls like 
the one you are investigating today is within our grasp. Thank 
you very much.
    [The prepared statement of Ms. DeWaal can be found on page 
48 in the appendix.]
    Chairman Harkin. Thank you very much, Caroline.
    Now we will turn to Mr. William Hubbard, former Senior 
Associate Commissioner for Policy, Planning, and Legislation at 
the Food and Drug Administration. Mr. Hubbard?

     STATEMENT OF WILLIAM HUBBARD, FORMER SENIOR ASSOCIATE 
 COMMISSIONER FOR POLICY, PLANNING, AND LEGISLATION, U.S. FOOD 
      AND DRUG ADMINISTRATION, CHAPEL HILL, NORTH CAROLINA

    Mr. Hubbard. Thank you, Mr. Chairman. I have a written 
statement, but I will just make a few extemporaneous remarks.
    I was at FDA for 27 years and the last 14 as an Associate 
Commissioner. I have dealt as frustratingly with this issue for 
many years, as you are expressing. I want to agree with your 
opening remarks, Mr. Chairman, about the fact that we don't 
have an operating system, which I think is absolutely true. 
Despite all of the advances we have made in science and 
technology, we have not brought them to bear on this problem. 
We simply haven't. In fact, FDA has a food safety system that 
is a relic of the 19th century. It is outmoded, outdated. It 
does not use modern scientific techniques. And it clearly needs 
a serious examination, in my view, by the Congress and the new 
administration.
    There are two particular areas I would like to focus on. 
One is FDA's capacity to work under the current paradigm. The 
current paradigm was developed over a century ago and it would 
have inspectors randomly go into food facilities and look 
around and see if they find a problem. They might get in every 
few years, and they would attempt to correct the problem.
    That has clearly failed, but one of the reasons it has 
failed is that FDA's food program has largely disappeared. When 
I came to FDA in the 1970's, there were 70,000 food firms. FDA 
inspected 35,000 times a year, so they got to everybody every 
couple of years, generally. Today, there are 150,000 registered 
firms with FDA and FDA does 7,000 food inspections. That 
basically means there is no ``there'' there.
    Now, the FDA believes there are about 6,000 high-risk 
firms, so they do try to get into those with some frequency, 
and they should, firms, for instance, that make canned goods 
that could result in botulism. But they don't get to the vast 
majority of the other firms.
    And you can correlate, Mr. Chairman, that as FDA inspectors 
left those facilities, stopped going in the 1970's and 1980's 
and 1990's, recalls went up and adverse findings in the 
inspections they did do also went up. So you clearly had a 
correlation between the regulators going away and the problems 
going up.
    Now, I want to reiterate, I think most of our food supply 
is very safe. But we clearly have these kinds of problems that 
keep on happening. I just think we have to look at a new 
paradigm, and that new paradigm exists. The meat program at 
USDA has shown it. The juice and seafood programs of the FDA 
have shown that you can build a system of preventive controls, 
where a firm is asked to identify the hazards that can affect 
their food and then prevent them from ever happening. So you 
are not relying on FDA to catch someone after the proverbial 
horse has left the barn and then fix it. The firm would have a 
food protection plan, a food safety plan where they would 
identify hazards like salmonella, make sure it never gets in 
the food, and then you just simply won't have these problems to 
the degree we have them.
    I will mention a few other things. FDA does need recall 
authority. As Dr. Sundlof said, they can often cajole a firm 
into a recall, but firms often stall. They like to talk to 
their lawyers. They like to think about it. They like to take a 
day or two. If FDA could order a recall, I think we could get 
things moving more quickly.
    And clearly, when you go into a firm, you need to get to 
those records very quickly. The bioterrorism act's record 
access provision is seriously flawed. FDA can't even, as Dr. 
Sundlof said, when they do a routine inspection, ask to see the 
records, even if the firm has the records, because you have got 
to have evidence that there is such a big problem, FDA has to 
pull that trigger on the Bioterrorism Act. So that clearly 
doesn't work.
    I will end my remarks by answering Senator Leahy's 
question. Yes, we are going to be here again, over and over 
again, unless we find a solution to this problem, because the 
outbreaks have tripled for FDA foods in the last 15 years, or 
almost tripled. That is a huge increase. So the problems are 
going up and FDA's ability to deal with them is going down. So 
we need to give the agency some resources and some authority to 
fix this problem, in my opinion.
    Thank you for your time.
    [The prepared statement of Mr. Hubbard can be found on page 
59 in the appendix.]
    Chairman Harkin. Thank you. Thank you very much, Mr. 
Hubbard. Very good testimony. Thank you.
    Senator Leahy, I know, has to get back to the floor and I 
am going to yield to him for opening questions.
    Senator Leahy. Thank you, Mr. Chairman.
    Ms. Meunier, I have read your testimony. I have talked with 
you personally, as have my staff. I still think of this almost 
as a Kafkaesque thing you went through. You described a little 
bit in your testimony about the coordination interaction 
between the Vermont State Health Department and the CDC and the 
FDA----
    Ms. Meunier. Yes.
    Senator Leahy [continuing]. At the same time when you were 
trying to get information yourself as a concerned mother. Do 
you want to tell me a little bit more about that? What went 
right? What went wrong?
    Ms. Meunier. Yes. Well, there was no one place I could go, 
and I have to say, I was not even aware that the FDA was 
involved. I thought this was between the CDC and my State 
health department. So I was never told that there was this FDA 
website that I could go to.
    Furthermore, it should be one website when there is a 
foodborne illness, not two, so I would just like to make that 
clear because people are totally confused as toward who is in 
charge. Is it my State? Is it the Federal Government?
    Senator Leahy. Especially in an era where we are all used 
to going on the Internet----
    Ms. Meunier. Yes.
    Senator Leahy [continuing]. To find out everything from----
    Ms. Meunier. Yes, we are. So when I actually talked to an 
FDA representative--and I do appreciate that, absolutely, that 
the FDA took my call where the CDC would not and refused to 
speak to me--I said, I didn't even know you guys were tracking 
this information. I didn't even know you were involved. But 
then when I found out that the FDA asked me all the same 
questions that the CDC asked me, I said to the representative, 
why don't you already have this information? Are you not 
allowed to share the same data base? My interpretation of her 
response was that she did not have that information.
    The health department working with the CDC, we are talking 
about days' and days' delay. She has to track me down by the 
phone. You know, I am a busy mom. There were so many gaps which 
were common sense not smart practices, the time delays getting 
from the CDC to the State, from the State to me, all via phone.
    Senator Leahy. If you ran your real estate business this 
way, it wouldn't last very long.
    Ms. Meunier. No, because you have to grow with the times. 
They are using 20th century techniques in a 21st century 
society.
    Senator Leahy. Thank you.
    Ms. Meunier. And also, can I just add that the statistical 
extrapolations that they used in this PulseNet I reviewed, and 
I can't correlate that to what I went through because it seems 
to me that I could have determined the outbreak long before the 
statistical correlations did.
    Senator Leahy. And it is one thing to just go through and 
recount everything you did, but also at the same time you had 
the very frightening experience of Christopher being in the 
hospital.
    Ms. Meunier. I did. It was an awful thing to go through. He 
was extremely ill, and for days, we had no idea. Neither did 
the hospital. Salmonella is not common where I live. I don't 
know anybody who has ever been food poisoned. And so we thought 
that he had terrible internal injuries. We thought--never once 
did anyone mention, and I called the best doctors in Vermont, 
salmonella poisoning. And never once did we ever fathom that a 
cracker could contain poisoning, ever. It never dawned on 
anyone.
    Senator Leahy. Especially the crackers that end up in kids' 
lunch pails or----
    Ms. Meunier. Absolutely, and he happened to eat a special 
lot that day, but----
    Senator Leahy. Ms. Smith DeWaal, in your testimony, you 
mentioned that, and I think I am quoting you correctly, FDA's 
infrequent inspections and the agency's oversight of State 
contracted inspections contribute to illness outbreaks. Could 
you speak a little bit more about mandatory inspection 
frequencies? How often should they be done?
    Ms. DeWaal. Thank you, Senator Leahy. This is a critical 
issue, I think, that will need to be resolved for any 
legislation to address problems at FDA. Let us look for a 
moment at the meat and poultry inspection system, which was 
passed in 1906 based on some scandals and problems that were 
happening at that time. They required a daily inspection at 
meat plants. For slaughter plants, they can't even start 
operations until the USDA employees are in the plants, in their 
position, really. And for even processed meat products, they 
have inspection on a daily basis.
    Now restaurants are another food venue very important to 
consumers. Those are inspected by States. The best advice to 
the States and the one States try to follow is to inspect 
restaurants twice a year, at least twice a year, and if they 
are having problems, they should get in there more often.
    The FDA inspection--first of all, the FDA has no mandatory 
inspection frequency today for food plants. They do have a 
mandatory inspection frequency for drugs, drug plants, which 
means they are going to go to the top of the list when they get 
to the inspection system. So today, there is no requirement. 
The average inspection rate is about once every 10 years, and 
as we heard, so much of the job is now being done by the States 
with inadequate coordination with the Federal Government.
    So I think there is a lot of room for improvement in these 
systems and we would be happy to work with your staff on the 
exact elements that could help improve it. Thank you.
    Senator Leahy. Thank you very much. Ms. Meunier, Ms. Smith 
DeWaal, Mr. Hubbard, thank you very much. I know all of you 
have concern in this area. I appreciate you taking the time.
    Mr. Chairman, thank you for holding this hearing.
    Chairman Harkin. You are welcome.
    I now yield to Senator Chambliss.
    Senator Chambliss. Thank you, Mr. Chairman.
    Ms. Meunier, first of all, we are glad your son is doing 
better.
    Ms. Meunier. Senator Chambliss, I would like to address 
that. In my experience, when you have such a bad infection--the 
salmonella causes an infection called C. diff, which is 
Clostridium difficile. He got those both at the same time. Is 
there a possibility C. diff was in the food? I ask this 
question to you and I ask it to the CDC. We do not know enough 
about the growing concern of C. diff, and it is an awful, 
awful, nasty infection.
    Christopher had both as a result of eating these crackers. 
He was extremely ill and it is going to take a long time for 
full recovery from this illness. I don't know how other people 
deal with salmonella, but one of my beefs with keep saying that 
these salmonella patients have recovered is that is not the 
truth. Many people have lingering arthritis as a result. My son 
has arthritis now, a 7-year-old. It comes and goes. I don't 
know if he will fully recover from that ever.
    So food poisoning, while in some cases can be absolutely 
intermittent and somebody be totally healed within a week, but 
not in all cases and certainly not in the case of my son.
    Senator Chambliss. Did you have occasion to go online to 
the CDC website at all during this process, and if so, at what 
point in time would you have gone on to check for salmonella?
    Ms. Meunier. I went into the CDC website later on in the 
process. I was not aware that there was a website. I was doing 
nationwide searches on my own, just data searches through the 
web to find out what was going on. So had I known there was a 
CDC website that I could get information from, I would have 
gone first and foremost to that website.
    Senator Chambliss. OK. So you didn't obviously find out 
anything about PulseNet early in the process.
    Ms. Meunier. I read about PulseNet, yes. I also read that I 
am not sure that every State--I don't know how it interacts in 
every single State, all 50 States.
    Senator Chambliss. OK. Ms. Smith DeWaal, Mr. Hubbard, I 
appreciate your comment about recall. We can get ourselves into 
a very difficult situation if we go too far, but yet to not 
give FDA some authority here more than what they have got, I am 
just not sure that is the right thing to do, either, and here 
is my dilemma.
    We talked a little bit about this tomato issue last year. 
FDA identified tomatoes as a source of salmonella last year and 
issued a warning to all of America, don't eat tomatoes. And 
this went on for a period of weeks. A month after FDA issued 
that warning to the American consumer, they made a 
determination that it wasn't tomatoes at all, that it was 
peppers that came out of Mexico. If FDA had the authority to 
recall product on its own, they would have done so immediately, 
I am sure, and they would have recalled all tomato products.
    During that month, the tomato industry in my county and in 
my part of the country was devastated, lost hundreds of 
millions of dollars that they haven't received a dime from, and 
it was not the farmers' fault. Obviously, it was a reaction on 
the part of FDA, right or wrong. In this case, it was wrong. 
They used the best information they had.
    So my question to you is, how do we really go about 
thinking from a recall standpoint how much authority we give 
the FDA and how much leeway should they have relative to this 
issue of recall?
    Mr. Hubbard. Could I, Mr. Chambliss, defend FDA on that 
tomato point, if I may? The CDC determines what food they link 
with a foodborne outbreak, and so CDC instructed FDA that they 
had determined it was tomatoes through their epidemiological 
findings and their questionnaire process, which is not an exact 
science.
    About midway through the outbreak, as I understand it from 
FDA officials, the FDA field folks recognized that there was a 
disconnect between the growing patterns in Florida and Georgia 
and other States and the epidemiological findings, and so they 
went to CDC and asked if they could see the raw epidemiological 
data so that they could confirm that, in fact, it was tomatoes, 
because FDA did not believe it was tomatoes at that point. FDA 
was denied that information, and so they continued to chase 
tomatoes fruitlessly for several more weeks. Finally, when they 
were allowed to turn to peppers, I think it took about 2 days 
to find the contaminated peppers on the Mexican border.
    So the system is clearly flawed in the sense that you don't 
have the communication and cooperation between State health 
departments, the CDC, and the FDA to identify the right food 
quickly. Now, I am sure if CDC were here at this table, they 
would be explaining that circumstance very differently than I 
just have. But the point is there was not agreement that it was 
tomatoes. It turned out it wasn't tomatoes, but a lot of effort 
went into it.
    But to your question on recall, I think if FDA could recall 
only so-called Class I products where you have a risk of 
serious illness or death, then I think even the food industry 
would agree that a recall in those conditions would be 
acceptable. A recall for, say, a labeling violation would be 
perhaps something that they would not agree with.
    Ms. DeWaal. Thank you, Senator Chambliss. I think your 
question really illustrates the importance of prevention to 
really be our first line of defense. Any time one bad actor, 
whether they be in Mexico in that case or in the U.S., has a 
problem, it impacts the entire industry. I mean, I am sure in 
Georgia right now, they are very concerned about the impact of 
this one outbreak and this one bad actor on what is happening 
to sales of their products in the future. So the key is 
prevention.
    When you get to the point of responding to an outbreak, the 
public health officials have to take the most conservative 
approach to protect public health and FDA did use the best 
epidemiology that they had. There is a possibility that 
tomatoes were grown in that part of Mexico early in the season 
and then it changed over to peppers. I mean, that is a 
possibility I have discussed with officials at FDA. So it is 
possible that there was an early--that tomatoes may have been 
implicated early because there was actually a link.
    But the reality is these investigations are very complex. 
They are a lot like criminal investigations. They have got to 
go out and do gumshoe detective work. And the key to 
legislation that we are promoting in Congress is prevention. 
Let us get all of these plants, even to the farm level, let us 
get written food safety plans in place so they can be audited 
by the State, by the Federal Government, maybe even by the 
customer. But let us get these plans in place and let these 
records, the records that support the plans, be accessible to 
CDC, FDA, USDA when they need them for an outbreak. Thank you.
    Senator Chambliss. Your point, Mr. Hubbard, about the fact 
that this is not an exact science, I mean, you are exactly 
right. In addition to that, you throw in the complications of 
the fact that those peppers came across from Mexico and we have 
got an inspection process, but obviously we are not doing a 
good enough job there or we would not have had that issue back 
at that point in time.
    I appreciate the testimony of all three of you. You have 
been very----
    Ms. Meunier. Senator Chambliss, can I say one more thing? I 
am sorry for interrupting you. On PulseNet, anything I have 
read and anything I heard, and I believe I just heard a doctor 
say something, there is a huge lag time before something gets 
to PulseNet and genetically typed, and then afterwards when you 
get the description of what the foods have been eaten that 
created the type that went into the PulseNet. And anything I 
have read speak up to a two-week lag time, and then you are 
asking people who have been poisoned what they ate 2 weeks ago. 
And what I have proposed will put a shortening to that time 
period.
    Senator Chambliss. Well, the particular reason I asked you 
about that is that on November the 10th, there was this 
monitoring of clusters of salmonella outbreaks around the 
country that was on PulseNet. Sixteen States were involved. I 
don't know whether Vermont was one of them or not. But if you 
had had access to PulseNet, or better yet, your doctor had had 
access to PulseNet and had gone in and looked at that, or if 
nothing else put your child's information on there, just 
imagine what that could have done----
    Ms. Meunier. Absolutely, and if we were able to have put 
into PulseNet what he had eaten, everyone would have that 
information instantaneously.
    Senator Chambliss. Yes. Well, I think whether it is recall 
or whether it is after we discover an outbreak, that there is a 
huge disconnect and a lack of information sharing. Everything 
every one of you have said highlights that. We wrestle with 
this in the intelligence community and we are doing a better 
job. We have just got to do a better job in the food safety 
area. So thank you very much.
    Chairman Harkin. Thank you very much, Senator.
    Senator Johanns?
    Senator Johanns. Just a couple of questions and maybe an 
observation. I will start with the observation. Having worked 
with FDA on some really complex food safety issues--melamine 
would be a good example--I have to tell you my impression was 
that they were doing as much as they could with the resources 
available. I really think it is important to focus on how much 
they can do and how far they can go with the resources at their 
disposal.
    You point out the resources have lessened. I certainly 
don't debate that at all. That is something we have got to pay 
attention to on this committee. But that is the observation.
    The second thing is a question. I was reading the 
testimony, and this actually comes from the written testimony 
of Dr. Sundlof, but I must admit, it gave me a very, very deep 
concern. Here is what it says. ``Peanut butter is sold by PCA 
in bulk containers ranging in size from five to 1,700 pounds. 
The peanut paste is sold in sizes ranging from 35-pound 
containers to tanker trucks. However, through its 
investigation, FDA has determined that PCA distributed 
potentially contaminated products to more than 300 consignee 
firms, many of whom then further distributed products, for 
consumption as peanut butter or for use as ingredients in 
hundreds of different products, such as cookies, crackers, 
cereal, candy and ice cream.''.
    So my question today, what I would ask of you, Ms. Smith 
DeWaal, where do you feel we are at with the recall? What is 
your level of comfort with it? Give me a sense of that.
    Ms. DeWaal. Well, thank you, Senator Johanns. We have been 
expressing concern since the recall was first announced about 
the shelf life of these products. I brought in these recalled 
peanut butter crackers that came out of the pantry of our 
receptionist at CSPI who is over 60 and was very happy to give 
them to me. Luckily, she had not eaten them. These products can 
be in people's kitchens, on their shelves for a long period of 
time.
    We are urging--earlier this week at CSPI, we asked--we are 
sending an open letter to retailers that have customer loyalty 
programs to actually send out alerts to people who purchased 
these products because it is really important that we get them 
out of people's kitchens, get them out of their pantries.
    Peanut butter isn't like spinach or ground beef or many 
other products which have a natural shelf life. These things 
seem to last forever. I mean, they probably don't and there is 
probably a technical shelf life answer, but the reality is for 
a lot of consumers you buy a jar of peanut butter and you use 
it for however long until it is empty. So it is critically 
important that the actions continue.
    I mean, a lot of the media alerts, and FDA, I think, and 
CDC have been trying to do a good job at doing regular media 
updates and telling the media they are relying on them to get 
the information out, and I have seen a lot of responsible 
media. But we have to overcome the fact that consumers don't--
consumers think food is safe and they will see a package like 
that and say, oh, this couldn't hurt me.
    So we really have to get it off the shelves. We have to get 
it out of vending machines. I have more concern in some ways 
because this outbreak has already killed eight people, caused 
huge numbers of illnesses, and it could go on. I have got the 
epidemiologic curve here which many of you have been referring 
to during your questions, but this could go on for a long time 
unless we can get--really actively get these products out of--
off the retail shelves, but also out of people's homes.
    Senator Johanns. There are so many things in this hearing--
I am running out of time already--that we can focus on, but I 
have to tell you, I see it as kind of a triage situation. You 
are right, this has a long shelf life. We have got product out 
there. I guess if there is anything I would ask of, whether it 
is your group, FDA, or whatever, is just to be kept appraised 
of what we think we are accomplishing in terms of getting 
dangerous product taken care of and consumers protected.
    Senator Chambliss is right. You are always trying to figure 
out the best course of action. These are complex issues. But 
your testimony indicates how dangerous this can be. A healthy, 
very young man and all of a sudden is in very, very serious 
trouble very, very quickly, and you are trying to figure out 
what the heck went wrong. You can only imagine how dangerous 
this is for an elderly person that enjoys peanut butter on 
their toast in the morning. It is deadly.
    Thank you.
    Chairman Harkin. Thank you very much, Senator, and again, I 
thank all of you. This has been very good.
    Dr. Sundlof, I am going to have you come back up because I 
want to ask you some questions about what Ms. Meunier has said 
and to see if that tracks with some of the things we might want 
to do.
    But I just, both for Caroline and also for you, Mr. 
Hubbard, I just wanted to--it seems in both of your 
testimonies, what I get out of that is that we simply have an 
outdated system here, that whatever worked 50 or 100 years ago 
just simply isn't working now and it needs to be updated, both 
in terms of inspections, requirements for reporting, and in 
your case, Ms. DeWaal, in terms of fines. You pointed out when 
you have a $1,000 fine, that is not much of a deterrent at all.
    But what I would just like to cover with both of you, and 
you both kind of covered it in your testimonies, and that is 
right now, the current method as we have had in the past for 
FDA inspection involves an inspector showing up at the plant, 
which just basically is a snapshot in time as to what is really 
happening. Now we know from what we have done at FSIS with the 
HACCP system. Should we change that whole paradigm of how FDA 
operates? You kind of hit on that a little bit, Mr. Hubbard. I 
wonder if you could just follow up a little bit more on that. 
Do we need HACCP to go beyond seafood and----
    Mr. Hubbard. Juice.
    Chairman Harkin [continuing]. Juice? Do we need it to go 
beyond that?
    Mr. Hubbard. Absolutely. I think that is the No. 1 key. 
These other things, like recall authority, are very helpful. 
But if we could move toward universal HACCP across the food 
supply, I believe we would have an exponentially safer food 
supply, and you would have firms with the incentive to protect 
their food much more. FDA could then become more of an auditor 
and not so much of a punisher.
    I absolutely believe that, and I think the proof is in the 
pudding for meat and juice and seafood. We have seen outbreaks 
going down in those commodity areas. We are seeing better 
inspection results when the inspectors do go in. And the 
industry has accepted that as the way to go. In fact, HACCP was 
developed by the food industry. So in my view, that is clearly 
the way to go.
    Chairman Harkin. Now, there are some other things you 
mentioned, also, and that was enforcement activities. Both of 
you mentioned that. Annual registration of all food facilities. 
Accreditation of private laboratories. You asked about the 
private labs and stuff out there. I mean, who are these people? 
Do we know, and do they report to FDA at all? I am asking that 
question. Do these private laboratories, when they do 
something, do they report to FDA? We know now that the plants 
don't have to report to FDA. I earlier stated that as a big 
loophole. Maybe there is another loophole here if all these 
private labs out there don't have to report, either. Is that 
the case?
    Ms. DeWaal. That is correct. The labs are actually working 
for the plants, and so there are--unless the government is 
actually drawing the samples, and those samples would be done 
by government labs--the sampling that is done by companies, it 
is all voluntary and they hire the lab and in this case, they 
seem to send the--if they didn't like the test results the 
first time, they send it back for retesting and ship the 
product when the retest was negative. So basically the 
companies--these are private contractual relationships and the 
labs have no responsibility to report findings of potentially 
dangerous products to the government.
    In legislation that at least is being discussed on the 
Senate side, there would be a laboratory accreditation 
component that has certainly been discussed, and that is 
something that would certainly help. But we need to build all 
these records in. These testing records should become part of 
this mandatory HACCP system or a written food safety plan, 
however you want to frame it, to make sure that they capture 
the records that are part of the ongoing food safety monitoring 
in the plant itself.
    Chairman Harkin. Let me ask one other question. It has been 
floating around for a long time. It gets introduced as a bill 
now and then--I think I may have even been on it periodically--
and that was to set up a single food safety agency. Some people 
have said that the FDA, the Food and Drug Administration, 
really ought to be named the Drug Administration. They spend 
more of their time on drugs, certifying drugs, overseeing drugs 
in this country, but very little on food. Maybe we just need 
one single food safety agency. Do you have any thoughts on 
that, any of you?
    Ms. Meunier. I think it is a great idea, sir.
    Mr. Hubbard. Ms. DeWaal will certainly endorse it. I 
actually spent a lot of time thinking about that in my time at 
FDA and there are clearly two points of view. The programs used 
to be together many years ago, and they diverged, and many 
argue that the drug emphasis in FDA is one of the reasons for 
the resource shortfall in the food area at FDA, that the 
commissioners and secretaries and Presidents over the years 
have made sure drug review got taken care of and it came out of 
the food side of FDA. And there is actually some empirical 
evidence to support that point of view.
    On the other hand, the FDA is a significant brand name in 
the United States and if you break it up and create this new 
thing, is it going to have the credibility and all that the FDA 
has?
    It is a tough call in many ways, and there is also the 
issue of if you do do it, would you spend all your time moving 
boxes as opposed to fixing the problem.
    Ms. DeWaal. Let me give you the current thinking on this 
issue. Ms. Meunier and myself were actually at a bill 
introduction yesterday on the House side. The current thinking 
right now is that it wouldn't make sense to create a single 
unitary agency until we modernize both sides of the house.
    Right now, the USDA law is significantly different from the 
one the FDA is operating under. So it really makes sense to 
modernize both FDA's legal structure for food and eventually, 
though it is not really before you right now, the USDA model. 
And then after that, if it makes sense, you might create a 
single agency. But it is critically important, and the bill 
that was introduced by Chairman of House Agriculture 
Appropriations Rosa Delauro yesterday would take the food 
components, which you had two people testifying from FDA here 
today. That is because no one is really in charge of all of the 
components of food. You take all the components and put them 
under a new Commissioner of Food Safety or Nutrition who 
reports directly to the Secretary of Health and Human Services.
    Chairman Harkin. Well, why not just--since the food 
component at FDA, and I will ask Dr. Sundlof, maybe he doesn't 
know, it is a smaller part of FDA than the whole drug regime 
is--why don't you just move that over to the Food Safety 
Inspection Service? They have a history. They know how to do 
HACCP. We have been doing it for some years now. Why not do 
that?
    Ms. DeWaal. Again, it would swallow--you have got two 
competing legal structures. So for USDA, they have got a lot of 
resources, but that is because they are required by law to 
inspect every meat plant every day, and that law is--I mean, I 
am not hearing that that law is going to change anytime soon. 
So simply taking the two existing laws and combining the 
agencies wouldn't actually fix the problems and wouldn't 
necessarily prevent the peanut butter outbreak.
    So what we have got to do is actually build the system at 
FDA, and you can either do that by keeping everything together 
at FDA--the brand name is important, and in the proposal the 
FDA brand will retain, will remain, but it will be the Federal 
Drug and Medical Device Agency. The FDA will regulate drugs and 
medical devices and there would be an FSA, the Food Safety 
Authority or Administration, that regulates on the food side. 
FSA is actually the name of an agency also in Britain that was 
formed after BSE really destroyed consumer confidence in their 
system.
    So you really have a proposal that is a very interesting 
one on the House side. On the Senate side, the legislation that 
we saw introduced last year, which was bipartisan, did not make 
that shift. It tries to fix things just within FDA. But I am 
concerned, Senator, that unless you address this structural 
problem where Dr. Sundlof is in charge of policy, but you have 
got someone over at the Office of Regulatory Affairs who 
actually manages who gets inspected in the food industry, the 
Commissioner's office manages the budget, until you address the 
fact that food is really divided into all these different 
units, we are going to see these problems continue.
    Chairman Harkin. Well, I don't know. I am not certain I 
have a firm view on that myself, either. It just seems to me 
that there are just too many pieces out there and no one is 
really paying much attention to food safety in the beginning, 
aside from the recall problems and public knowledge right away 
of outbreaks and things that you pointed out, Ms. Meunier.
    Are you familiar with--the FDA has advanced the Food 
Protection Plan as a framework to improve food safety. The GAO 
has expressed concern that the plan does not contain enough 
specific information to assess whether it would improve FDA's 
food safety program. Are you familiar with it, and what do you 
think, any of you?
    Mr. Hubbard. Well, it is a broad sort of road map for 
improving food safety. I think it is fine. It is not--there is 
no money attached to it to do anything more. There are no 
specifics, as you say. There are no particular regulations that 
would be promulgated or new procedures. So it is fine as a very 
broad general goal, but it would need a great deal of implement 
to implement, in my opinion.
    Ms. DeWaal. The one element that I would want to bring to 
your attention in the plan, because I think it is a fine plan, 
but it really focuses on what FDA considers high-risk 
facilities. I can tell you, PCA was not considered a high-risk 
facility because peanut butter generally isn't. So it is--and 
FDA also really doesn't have the data that it would need. I 
mean, you know there has been controversy on this concept of 
risk-based inspection over at USDA. Well, they have a much more 
robust data set to support that than FDA has to support its 
decision about high-risk versus low-risk facilities.
    Chairman Harkin. One last thing. If there had been a HACCP 
plan in effect at this plant, how confident are you that that 
would have prevented this salmonella contamination?
    Mr. Hubbard. If there was a functioning HACCP plan, I think 
it would absolutely have because the firm would have identified 
salmonella as one of the likely risks to peanuts and peanut 
butter. The firm would have made sure the peanuts were roasted 
to a high enough level so that they were clean at the time they 
went into the processor to make the peanut butter. And their 
equipment would have been cleaned periodically. The skylights 
would not have leaked. The roof would not have leaked. The 
roaches would not be there. The rodents would not be there. And 
you would not have had the contamination. And therefore, in my 
opinion, a functioning HACCP plan would absolutely have 
prevented this problem.
    Ms. DeWaal. It also would have given the State inspectors a 
lot more to go on during their inspection. They could have 
walked in. They could have seen the plan. They hopefully would 
have seen the test results. But they also could have looked at 
the plant itself and seen that it wasn't actually living up to 
its HACCP plan.
    Chairman Harkin. Thank you. Thank you all very, very much. 
I appreciate your coming here, your testimony, and you are 
right. C. diff is--I have been looking at this for some time 
now----
    Ms. Meunier. It needs to be looked at further, I think.
    Chairman Harkin. I will tell you, it is getting more and 
more around the country----
    Ms. Meunier. Yes. There is something called community-
acquired C. diff out there, and I read some analog yesterday 
that said it may possibly be in food now. So my concern is, was 
it in this cracker? I don't know. We do not know how he got it.
    Chairman Harkin. Thank you all very, very much.
    I would like to ask Dr. Sundlof if you could just come back 
to the table, please. I just want to follow up just on a couple 
of things with you here.
    Senator Chambliss. Let us get Dr. Khan.
    Chairman Harkin. Oh, yes, Dr. Khan, Admiral Khan from CDC.
    I just wanted to cover again, you heard the testimony of 
Ms. Meunier. I have been reading it over and I can just sense 
the frustration that she must have had at that time. You have 
this sick child, and trying to get information and trying to 
find avenues of accessibility.
    Now, she did say that when she found the FDA, she said, 
``thankfully, I found someone willing to listen. Unfortunately, 
it was the weekend and that Monday was a holiday, so no one 
could pick up the crackers until Tuesday. However, in a 
shocking twist, the woman I spoke with at FDA then also wanted 
to give me a questionnaire about all the foods Christopher had 
eaten, all the same information I had already given to CDC. I 
don't understand why the various agencies working on this 
outbreak did not already have this information and how they can 
share it.''
    And then it was all phone call. I wrote a note here, no e-
mail? Is there any way that you can get e-mail out on this? It 
seems to me such a simple thing. How do you respond to that? Is 
this something we should be thinking about doing at FDA?
    Mr. Sundlof. We are always looking for better ways of 
communicating, and every time we go through one of these 
situations, we find more ways. So we are taking advantage of a 
lot of new technologies, things that I don't even know what 
they are, but we are doing something called Twitter. We have 
bloginars. All of these are strange terms to me. But we feel it 
is extremely important to get the information out to people who 
need it.
    When we had the melamine situation, we were trying our best 
to reach out to the Asian community in the event that infant 
formula from China came into the United States. Since the 
salmonella St. Paul in peppers outbreak, we have held high-
level meetings with CDC just to talk about how we can 
communicate better and how we can get our message out.
    In this particular outbreak, we were concerned about people 
who didn't have access to the Internet, and that is especially 
prevalent in our senior citizens, who have not grown up with 
this technology, and how do we reach out to those people? CDC 
has an information hotline where they are actually encouraging 
people who don't have Internet access to call their information 
hotline so that they can look up the list of recalled products.
    I certainly agree that communication in these situations 
where we need to get information out quickly to people is 
paramount in limiting the scope of the disease and we will 
continue to work toward that.
    Chairman Harkin. Well, it just seems to me that 
Christopher's doctors, they now have salmonella. They have 
asked for the--I don't know if they did, but they could ask if 
there is any outbreak of a possible foodborne pathogen, what 
did you eat, and all they have got to do is enter that into a 
data base someplace. There should be software that would take 
that. All of a sudden, it flares up on your system. Oh, 
Christopher may have eaten five or six or seven things that 
day, and someone in Minnesota ate five or six or seven things 
and somebody else ate, but all of a sudden they all ate 
something dealing with peanut butter and that would flag it 
right away. It seems to me a software program like that is not 
very difficult to design. I ask both of you that.
    Mr. Sundlof. I don't disagree. I would defer to Admiral 
Khan because these are the kinds of information that CDC 
handles.
    Chairman Harkin. This is something that I would think CDC 
would have out there.
    Admiral Khan. Thank you, Dr. Sundlof, and thank you, Mr. 
Chairman. A couple of comments.
    First, let me clarify dates. So even though there were 
cases in September and October, we didn't hear about them until 
November in PulseNet, and that again goes back to these delays.
    Now, back to Ms. Meunier. I really want to thank her, what 
as an epidemiologist I call as a case or as a doctor, I call a 
patient really as a person, an individual who got sick with a 
disease and tragically, it sounds like, has some complications 
from that disease.
    I also want to congratulate her and you on the comment 
about the solution. We really need to get better with this time 
line. How do we shorten these delays? And it is really about 
these new tools that allow us to do it, and there are numerous 
new tools, as I outlined before, communication, information 
tools that would allow us to do it.
    And finally, I am quite disturbed that she tried to contact 
somebody at the CDC and was not able to. We do have a system 
that allows people to do so.
    But the heart of this issue is communications, and we are 
doing a lot of innovative things with communications, such as 
you have said, blogs and Twitter and widgets that go onto 
websites, podcasts, and it is disturbing that people do not 
recognize that the CDC website is available for information. We 
have been careful about centralizing information. All the 
recall information is at one site, so you don't need to go to 
100 different sites. You are not getting different messages. 
You are getting a single consistent message every time.
    Chairman Harkin. OK. Is there--is this site someplace where 
a local pediatrician or doctor could go in there right away and 
input some information right away and it goes into a system 
that is collated with all the other information that is coming 
in? Is there such a site?
    Admiral Khan. No, sir, and that goes back to the tools we 
need. Those would be tools at the State and local level that 
currently do not exist so that if there is an individual who 
has an unfortunate diagnosis of one of these illnesses, right 
away, while their memory is fresh, you can get a full history 
questionnaire completed on them, and then as you log many of 
those together, you can look for the association then amongst 
the people who are ill and connect that to your laboratory 
patterns in PulseNet and go, voila, this is what the connection 
between those two are. So these are new tools that are needed 
at the local, State, and national level.
    Chairman Harkin. Well, I am going to be interested in 
following up on that with CDC. Would you be in charge of that 
at CDC? Would that be under your jurisdiction?
    Admiral Khan. Sir----
    Chairman Harkin. I want to know who is responsible. Who can 
I continue to talk with about this?
    Admiral Khan. You can continue to contact us in the 
National Center for Zoonotic, Vector-borne, and Enteric 
Diseases.
    Chairman Harkin. Well, because I am. I am going to write a 
formal letter to you at CDC outlining this and asking how you 
would structure such a system and when it could be implemented, 
how much would it cost, do you have the wherewithal to do it.
    Admiral Khan. We would be glad to respond to that request, 
Senator.
    Chairman Harkin. That really gets to the heart of what Ms. 
Meunier was talking about, is getting information in 
immediately, making sure it is correlated with all other 
information from other parts of the country, to flag these as 
soon as possible. And then they could go on that site and see, 
well, are there other people having the same diagnosis, for 
example,
    That is really what I wanted to cover with them. I don't 
know if you want to go into anything.
    Senator Chambliss. I just have one quick question. Admiral 
Khan, do you know whether or not on November 10, when PulseNet 
revealed this cluster of outbreaks within those 16 States, 
whether or not Vermont was one of those 16 States?
    Admiral Khan. Sir, I do not have that in front of me, but I 
will be glad to get back to you.
    Senator Chambliss. If you could explore that information. 
And just to further one of Senator Harkin's points there, it 
ought to be pretty easy to have some sort of software system 
there to where a physician in any emergency room that is 
treating a patient for a potential salmonella poisoning or 
infection could go to a CDC or an FDA, there ought to be some 
centralized website, but could pull up other cases that might 
be taking place around the country, and most importantly, to 
input information that they pick up in that emergency room from 
that patient.
    This is one of the things that it ought not take 
legislation to do. There is no reason CDC and FDA, and you may 
need to involve some other agencies, I don't know off the top 
of my head who, but maybe the VA or somebody that is within the 
government that is a health care system, but there just ought 
to be some sort of central data bank for information like this. 
It just looks like it would go a long ways toward preventing a 
nationwide outbreak that extended from 13 States to 43 States.
    Thank you.
    Chairman Harkin. Well, thank you very much, Senator 
Chambliss.
    Thank you all very much for being here. Again, I hope we 
don't fall into what Mr. Hubbard said, we just continue to have 
these hearings and have these hearings and not much seems to 
happen. Something has got to happen here. I am encouraged by 
what President Obama said on Monday. He promised, quote, ``a 
complete review of FDA operations.'' Quote, ``I think that the 
FDA has not been able to catch some of these things as quickly 
as I expect them to catch,'' Mr. Obama said in an interview on 
the ``Today'' show.
    So hopefully, with the executive branch and with Congress, 
we can make some changes that will both, again, prevent--that 
is why the HACCP thing. We have got to think about prevention 
first. Even with that, once in a while things are going to 
happen and then we need the quickest possible information to 
parents and to our medical community out there to get that 
information out and then to get it to FDA as soon as possible 
so that recalls can happen.
    But I also think there are some of these other loopholes, 
in terms of accreditation of these private labs that are doing 
it, a requirement that they have to report to you if they find 
any foodborne pathogens, that they have to be required to 
report that to FDA along with any other State agency. If they 
have to report it to the State agency, they can send a copy to 
FDA.
    These are things, at a minimum, that we ought to be doing, 
I think. The broader picture, of course, is resources for the 
FDA and what that is going to require. That is another thing we 
are going to have to wrestle with.
    But thank you all very much. This has been a very 
enlightening hearing. You have been great witnesses and we 
appreciate your being here and your testimony and we look 
forward to working with you in the future. Thank you very much.
    The committee will stand in recess.
    Admiral Khan. Thank you, Senator.
    [Whereupon, at 12:37 p.m., the committee was adjourned.]
      
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