[Senate Hearing 109-834]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 109-834
 
  FOOD SAFETY: CURRENT CHALLENGES AND NEW IDEAS TO SAFEGUARD CONSUMERS

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                                   ON

   EXAMINING CURRENT CHALLENGES AND NEW IDEAS TO SAFEGUARD CONSUMERS 
 RELATING TO FOOD SAFETY, FOCUSING ON FOODBORNE ILLNESS IN GENERAL AND 
 THE RESPONSE TO THE RECENT OUTBREAK OF E. COLI INFECTIONS ASSOCIATED 
                           WITH FRESH SPINACH

                               __________

                           NOVEMBER 15, 2006

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                   MICHAEL B. ENZI, Wyoming, Chairman

JUDD GREGG, New Hampshire            EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee                CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
RICHARD BURR, North Carolina         BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia              JAMES M. JEFFORDS (I), Vermont
MIKE DeWINE, Ohio                    JEFF BINGAMAN, New Mexico
JOHN ENSIGN, Nevada                  PATTY MURRAY, Washington
ORRIN G. HATCH, Utah                 JACK REED, Rhode Island
JEFF SESSIONS, Alabama               HILLARY RODHAM CLINTON, New York
PAT ROBERTS, Kansas

               Katherine Brunett McGuire, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                      WEDNESDAY, NOVEMBER 15, 2006

                                                                   Page
Enzi, Hon. Michael B., Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Kennedy, Hon. Edward M., a U.S. Senator from the State of 
  Massachusetts, prepared statement..............................     3
Brackett, Robert, Director, Center for Food Safety and Applied 
  Nutrition, Food and Drug Administration, Rockville, MD.........     5
    Prepared statement...........................................     7
King, Lonnie, Senior Veterinarian, Centers for Disease Control 
  and Prevention, Atlanta, GA....................................    11
    Prepared statement...........................................    13
Reilly, Kevin, Deouty Director, Prevention Services, California 
  Department of Health Services, Sacremento, CA..................    25
    Prepared statement...........................................    31
Whitaker, Robert, President, MissionStar Processing, Salinas, CA.    43
    Prepared statement...........................................    45
Crawford, Terri-Anne, Vice President and Chief Operating Officer, 
  Franwell, Inc., Plant City, FL.................................    48
    Prepared statement...........................................    51
Palmer, Jeff, President, DayMark Safety Systems, Bowling Green, 
  OH.............................................................    54
    Prepared statement...........................................    56
Vazzana, John, President and CEO, Intralytik, Inc., Baltimore, MD    61
    Prepared statement...........................................    63
Durbin, Hon. Richard, a U.S. Senator from the State of Illinois, 
  prepared statement.............................................    76

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Verdelli, Dan, Executive Vice President, Verdelli Farms, Inc.    78
    Response to questions of Senator Enzi and Senator Kennedy by 
      Robert E. Brackett.........................................    79
    Response to questions of Senator Enzi by Lonnie J. King......    86
    Response to questions of Senator Kennedy by Lonnie J. King...    89
    Response to questions of Senator Enzi by Kevin Reilly........    89
    Response to questions of Senator Kennedy by Kevin Reilly.....    90
    Response to questions of Senator Enzi by Robert Whitaker.....    91
    Response to questions of Senator Enzi by Terri Crawford......    92
    Response to questions of Senator Enzi by Jeff Palmer.........    95
    Response to questions of Senator Enzi by John Vazzana........    95

                                 (iii)

  


  FOOD SAFETY: CURRENT CHALLENGES AND NEW IDEAS TO SAFEGUARD CONSUMERS

                              ----------                              


                      WEDNESDAY, NOVEMBER 15, 2006

                                        U.S. Senate
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 3:00 p.m. in Room 
SD-430, Dirksen Senate Office Building, Hon. Mike Enzi, 
chairman of the committee, presiding.
    Present: Senators Enzi, Burr, and Isakson.

                   Opening Statement of Senator Enzi

    The Chairman. In our tradition of starting on time, I 
welcome all of you to our hearing on food safety. This kind 
bears out one of the principles of government. There are a 
number of other hearings going on right now. This one is very 
bipartisan. There is a lot of agreement on what has happened, 
what needs to be done, so consequently, the other committees 
will be covered better and will draw more Senators. But I want 
to assure you that the information that we gather today will be 
utilized by all of the Senators in completing the Agriculture 
Appropriations bill, making sure that we get it right. They may 
have questions that will result from the testimony and we will 
ask that any that testify today answer those questions as 
promptly as possible so that we can move forward with what is 
needed to be done.
    This is not a partisan issue. We all want our food supply 
to be as safe as possible. Instead, it's our shared goal that 
requires cooperation and teamwork through a complicated process 
that we will examine today. There is a lot of interaction.
    For many of us, the safety and reliability of our food 
system is something we all too often take for granted, day by 
day, as we consume our favorite beverages, enjoy a quick snack 
or sit down to a meal at a local restaurant. We rely upon a 
system of checks and balances that take place behind the scenes 
that we are often unaware of until something goes wrong.
    Then and only then do we realize how dependent we are on 
the food safety system that is supported by the activities 
carried out by the Federal, State and local government agencies 
as well as by the food industry itself. Together they inspect, 
test, research and monitor our food supply from the farm or 
ranch where it was produced to the family dinner table where it 
was consumed. The type and amount of oversight they exercise 
depends on the food product and the degree of regulatory 
scrutiny they demand is commensurate with the degree of risk.
    Today's hearing will take a close look at the recent E. 
coli outbreak associated with bagged spinach and help us 
understand how it was identified, tracked and ultimately 
contained. We'll hear about interagency coordination and the 
cooperation of Federal and State officials during the outbreak. 
We'll also be examining some new and exciting technologies that 
could help limit future outbreaks or even prevent them.
    The Centers for Disease Control and Prevention, the CDC, 
estimates that foodborne illnesses affect 76 million Americans 
each year, which results in 325,000 hospitalizations and 
possibly 5,000 deaths. Food-borne illnesses also impose 
tremendous costs on the U.S. economy. The Department of 
Agriculture estimates costs associated with medical expenses, 
premature death and losses in productivity due to missed work 
from five major types of foodborne illnesses to be $6.9 billion 
annually. At the Federal level, within the Department of 
Agriculture, the Food Safety and Inspection Service regulates 
meat, poultry and processed egg products. Additional agencies 
in the Department of Agriculture support research on food 
safety and the economics of foodborne illness and ensure the 
safety of foods distributed through school nutrition programs.
    The Food and Drug Administration, Centers for Disease 
Control and Prevention and the National Institutes of Health, 
all housed within the Department of Health and Human Services 
and under the jurisdiction of this committee, play important 
roles in food safety. Two centers in the Food and Drug 
Administration, the Center for Food Safety and Applied 
Nutrition and the Center for Veterinary Medicine, ensure that 
all food produced domestically or imported, other than meat, 
poultry and processed eggs, is safe and that drugs given to 
animals raised to be used for human food do not cause health 
problems for humans. The Centers for Disease Control and 
Prevention tracks foodborne incidents and outbreaks and 
provides data and information to the other food safety 
agencies, while the National Institutes of Health is 
responsible for research on the health effects of foodborne 
illnesses and the effectiveness of possible treatments.
    Finally, the Office of Pesticide Programs of the 
Environmental Protection Agency is responsible for setting 
tolerances, the limit of the amount of residues from chemicals 
that can be found in or on food and for promoting safer means 
of test management and the National Marine Fishery Service at 
the Department of Commerce provides fishery inspection 
services.
    In addition to these longstanding authorities and 
activities in food safety, the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 required the 
Food and Drug Administration to register food processors, 
inspect their records and detain adulterated food. It also 
requires the Food and Drug Administration to issue regulations 
to ensure the safety of imported foods.
    Despite all this, food safety has been making the news 
lately. Late this summer, reports of an outbreak of illness due 
to a strain of E. coli bacteria began trickling in to State and 
Federal agencies. By the time the outbreak ended, there were 
204 confirmed cases in 26 States that resulted in three deaths. 
The outbreak was ultimately traced to bagged spinach from the 
Nation's salad bowl, a valley in California. The long-term 
effects of this outbreak on the spinach industry in California 
and across the Nation, as well as on consumer confidence in 
food safety, are not yet known. Just last month, the Centers 
for Disease Control began investigating a salmonella outbreak, 
which was traced back to tomatoes served at restaurants. 
Twenty-one States have reported 183 cases of illness due to 
these tomatoes. Food-borne illnesses associated with produce 
are particularly difficult to manage since the source of the 
illness is perishable and the product is likely to be consumed 
or thrown out before an illness becomes apparent.
    The United States has one of the best food safety systems 
in the world but even in the best of systems, there is always 
room for improvement. Those improvements can take many forms. 
For example, we can address how food becomes contaminated in 
the first place and we can make advances in the processing and 
the handling of food. Our surveillance testing and reporting 
systems represent areas we should evaluate as well as internal 
and external communications. Interagency coordination and 
cooperation between Federal and State officials is critical in 
identifying, tracking and responding to outbreaks of foodborne 
illnesses. I am particularly interested today in hearing how 
Federal and State agencies work together during an outbreak to 
assess and respond to a situation and how government at all 
levels communicates with the public.
    Finally, there is always new science. Tests to assist with 
diagnosis and treatment can be made faster and better. 
Improvements in processing, handling and traceability have 
potential to radically alter the landscape of potential risk. 
There will always be new and emerging foodborne pathogens that 
need to be identified. Our goal is always to be proactive 
rather than reactive in these situations. No one innovates like 
small business, and as we will hear later today, there is no 
shortage of companies with great new ideas to improve food 
safety.
    We'll hear first from Dr. Robert Brackett, the Director of 
the Center for Food Safety and Applied Nutrition at the Food 
and Drug Administration and Dr. Lonnie King, the Senior 
Veterinarian at the Centers for Disease Control and Prevention. 
I would note that Senator Kennedy has a scheduling conflict and 
is not here for an opening statement but he has asked that one 
be submitted for the record and it will be.
    [The prepared statement of Senator Kennedy follows:]

                 Prepared Statement of Senator Kennedy

    Thank you, Mr. Chairman, and I commend you for calling this 
hearing on the safety of America's food.
    You've arranged today's hearing with the same consideration 
and courtesy that have been the hallmark of your chairmanship. 
Your bipartisanship is a major reason why the committee has 
worked so effectively over the past 2 years on many problems 
affecting America's families, and it is the spirit in which the 
committee will continue to do business in the next Congress.
    In a few weeks, many of us will travel home to join our 
loved ones for a Thanksgiving meal that celebrates family, 
community, and our gratitude for the bounty that God has 
bestowed on our Nation.
    We too often take it for granted that the food we eat is 
safe and free from dangerous contamination. Recent outbreaks of 
E. coli [EE-coal-eye] and Salmonella have shown all too clearly 
that network of protections we count on to protect us from 
deadly foodborne illness is a frayed and inadequate patchwork.
    These outbreaks are examples of a wider problem with food 
safety. According to the CDC, there are 76 million cases of 
foodborne illness every year. Most of them result only in mild 
symptoms, but diseases caused by contaminated food cause over 
325,000 hospitalizations and 5,000 deaths every year, which 
means that an average of 13 Americans die from a foodborne 
illness every day.
    A few weeks ago, spinach contaminated with a deadly strain 
of E. coli made its way from farms in California into the food 
supply, and quickly spread to 26 States. When the outbreak was 
finally over, 204 individuals were infected, 102 were 
hospitalized, and 3 died.
    The deaths of a 2-year-old boy in Idaho and two elderly 
women in Wisconsin and Nebraska highlight the special 
vulnerability of children and seniors to these illnesses.
    Many dedicated professionals in local, State and Federal 
health agencies worked hard to respond to these outbreaks--but 
responding to an outbreak means that the battle is already 
lost. We need to learn what must be done to prevent these 
outbreaks from occurring in the first place.
    In November 2005--months before the recent outbreak--FDA 
had sent a letter to California vegetable firms outlining 
``serious concerns with the continuing outbreaks of foodborne 
illnesses associated with the consumption of fresh and fresh-
cut lettuce and other leafy greens.'' That November letter 
wasn't even the first warning by FDA. It reiterated concerns in 
a letter 9 months earlier.
    Despite these repeated warnings, corrective actions were 
not taken to prevent the subsequent outbreak. Obviously, we 
need to strengthen our approach to food safety.
    The questions are many. Does FDA need additional authority 
to take action when problems are identified? Does it have the 
authority but lack the resources to take action? Is 
coordination adequate among Federal agencies, and between 
Federal and State agencies, so that prompt action can be taken 
when problems are detected?
    Not every outbreak is foreseeable or preventable. But when 
there are persistent problems that have not been corrected, it 
is the responsibility of Congress to set things right, and 
that's the purpose of this hearing.
    We'll also hear today from representatives of firms with 
new technologies to improve food safety, through better 
detection of contamination and better ways to trace the flow of 
food products from farm to table. I look forward to their 
testimony, and to the testimony of representatives from our 
Federal and State health agencies. We're all partners in the 
effort to see that the food that American families eat is safe 
from contamination and danger.
    The Chairman. So if I could have Dr. Brackett and Dr. King 
take their places at the table.
    I would like to welcome Dr. Robert Brackett, who is the 
Director for the Center for Food Safety and Applied Nutrition 
at FDA and Dr. Lonnie King, the Senior Veterinarian at the CDC. 
Dr. Brackett will discuss FDA's role in identifying, tracking 
and containing the recent outbreak of E. coli associated with 
the bagged spinach and Dr. King will do the same for the CDC's 
efforts. We appreciate your being here today and we will begin 
with Dr. Brackett.

  STATEMENT OF DR. ROBERT BRACKETT, DIRECTOR, CENTER FOR FOOD 
  SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION, 
                         ROCKVILLE, MD

    Dr. Brackett. Good afternoon, Chairman Enzi and Senator 
Burr. I am Robert E. Brackett, Ph.D., Director of the Center 
for Food Safety and Applied Nutrition at the Food and Drug 
Administration, which is part of the Department of Health and 
Human Services.
    I would like to thank you for this opportunity to discuss 
food safety and the recent outbreak of E. coli O157:H7 that was 
linked to fresh spinach. I am also pleased to be here today 
with my colleague, Dr. Lonnie King, from the CDC.
    FDA is the Federal agency that regulates everything we eat 
except for meat, poultry and egg products, which are regulated 
by our partners at USDA. FDA's responsibility also extends to 
the live food animals and animal feed.
    Ensuring the safety of the food supply continues to be a 
top priority at FDA and the Administration and in recent years, 
we have done a great deal to protect the food supply from 
unintentional contamination as well as deliberate contamination 
and we have made significant progress in both. But we will 
continue to strive to reduce the incidence of foodborne illness 
to the lowest level possible. However, the recent E. coli 
outbreak shows that further progress is needed, particularly 
with ready-to-eat produce.
    Ready-to-eat fresh vegetables, fruits and prepared salads 
have a high potential risk of contamination because they are 
generally grown in the natural environment such as a field or 
orchard and are often consumed without cooking or other 
treatments that could eliminate pathogens that might be 
present. The number of illnesses associated with fresh produce 
is a continuing concern of the agency and we have worked on a 
number of initiatives to reduce the presence of pathogens in 
these foods and I will describe some of these initiatives later 
in my testimony.
    First I'd like to briefly describe FDA's actions in 
response to the recent outbreak.
    On the afternoon of September 13, the CDC informed FDA of a 
multi-state foodborne outbreak of E. coli, O157:H7 possibly 
associated with the consumption of fresh spinach. The next day, 
on September 14, the CDC notified FDA that the epidemiological 
data confirmed that fresh spinach was implicated as the source 
of the illnesses. That day, FDA, CDC, the State of California 
and other State officials began holding daily conference calls 
to share information, coordinate efforts to contain the spread 
of the outbreak, and investigate the cause.
    Also on September 14, FDA took immediate action to prevent 
further illness by alerting consumers and initiating an 
investigation. FDA's San Francisco district office and 
California Department of Health Services Food and Drug branch 
hosted a conference call with three spinach-processing firms in 
the Salinas area of California. We informed these firms that 
FDA would begin onsite investigations of processing facilities 
on that day.
    The response to the recent outbreak of E. coli is a good 
example of the close and effective working relationships that 
we enjoy with our food safety partners. The daily conference 
calls with FDA, CDC and the State officials were a vital and 
efficient means for sharing information, coordinating efforts 
to contain the spread of the outbreak and investigating the 
cause. This constant communication also enabled the Federal and 
State agencies to coordinate their public health messages for 
consumers. As I mentioned earlier, FDA continues to be 
concerned about the number of foodborne illness outbreaks 
associated with fresh produce. In recent years, FDA has 
initiated several activities to address these concerns and some 
of these activities include developing new guidance, conducting 
outreach to consumers, sampling and analyzing both domestic and 
imported produce for pathogens and working with the produce 
industry to promote the use of good growing, harvesting, 
packing, transporting and processing practices. In October 
2004, FDA announced a major initiative, the Produce Safety 
Action Plan, to help reduce the incidence of foodborne illness 
attributed to produce. As part of the Produce Safety Action 
Plan, the FDA has provided technical assistance to the produce 
industry in developing guidance for five specific commodity 
groups, that being cantaloupes, lettuce and leafy greens, 
tomatoes, green onions, and herbs. We are also working in a 
broader context to address the food safety concerns for all 
leafy greens.
    In the past 2 years, FDA twice wrote to the industry to 
express FDA's concern with continuing illness outbreaks and to 
express our expectations for industry to enhance the safety of 
these products. More recently, in August 2006, FDA and the 
State of California launched the Lettuce Safety Initiative to 
reduce public health risks associated with fresh and fresh-cut 
lettuce and leafy greens. In view of the recent E. coli O157:H7 
outbreak and after discussions with the industry, FDA and the 
State of California advised the industry to develop a plan to 
minimize the risk of another outbreak of all leafy greens, 
including lettuce.
    FDA, CDC and the State of California and the USDA continue 
to investigate the cause of the outbreak and once we've 
completed that investigation, FDA will hold a public meeting to 
address the larger issue of foodborne illness linked to leafy 
greens. As part of our evaluation, we will consider whether 
additional guidance and/or additional regulations will be 
necessary.
    In conclusion, FDA is working hard in collaboration with 
our Federal, State, local and international safety partners and 
with the industry, consumers and academia to improve the safety 
of fresh produce. We have made significant progress but will 
continue to strive to reduce the incidence of foodborne illness 
to the lowest level possible. Again, I thank you for the 
opportunity to discuss FDA's Food Safety Programs and I'd be 
happy to answer any questions.
    [The prepared statement of Dr. Brackett follows.]

            Prepared Statement of Robert E. Brackett, Ph.D.

                              INTRODUCTION

    Good afternoon, Chairman Enzi and members of the committee. I am 
Dr. Robert Brackett, Director of the Center for Food Safety and Applied 
Nutrition (CFSAN) at the Food and Drug Administration (FDA or the 
Agency), which is part of the Department of Health and Human Services 
(HHS). I am pleased to be here today with my colleague, Dr. Lonnie J. 
King, from the Centers for Disease Control and Prevention (CDC), which 
is also part of HHS. FDA appreciates the opportunity to discuss the 
recent outbreak of Escherichia coli (E. coli) O157:H7 linked to fresh 
spinach and the lessons learned from this outbreak.
    Ensuring the safety of the food supply continues to be a top 
priority for FDA and the Administration. In recent years, we have done 
a great deal to protect the food supply from unintentional 
contamination and from deliberate contamination. We have made 
significant progress in both, but will continue to strive to reduce the 
incidence of foodborne illness to the lowest level possible.
    A recent report (April 2006) issued by CDC, in collaboration with 
FDA and the U.S. Department of Agriculture (USDA), shows that progress 
has been made in reducing foodborne infections. This report provided 
preliminary surveillance data that show important declines in foodborne 
infections due to common pathogens in 2005 when compared against 
baseline data for the period 1996 through 1998. The report showed that 
the incidence of infections caused by Campylobacter, Listeria, 
Salmonella, Shiga toxin-producing E. coli O157, Shigella, and Yersinia 
has declined. Campylobacter and Listeria incidence are approaching 
levels targeted by national health objectives. This report shows that 
FDA's and USDA's efforts are working, and we are making progress. 
However, the recent E. coli outbreak shows that further progress is 
needed, particularly with ready-to-eat produce.
    Ready-to-eat fresh vegetables, fruits, and prepared salads have a 
high potential risk of contamination because they are generally grown 
in a natural environment (for example, a field or orchard) and are 
often consumed without cooking or other treatments that could eliminate 
pathogens if they are present. The number of illnesses associated with 
fresh produce is a continuing concern of the Agency, and we have worked 
on a number of initiatives to reduce the presence of pathogens in these 
foods.
    In my testimony today, I will first explain FDA's role in food 
safety. Then, I will discuss FDA's response to the recent E. coli 
outbreak and the ongoing investigation. I also will describe some of 
the specific efforts that FDA is taking to enhance the safety of fresh 
produce to prevent future outbreaks. Finally, I will review some of the 
next steps we plan to take to work with our food safety partners to 
improve the safety of these foods.

                       FDA'S ROLE IN FOOD SAFETY

    FDA's primary mission is to protect the public health. Ensuring 
that FDA-regulated products are safe and secure is a vital part of that 
mission. FDA is the Federal agency that regulates everything we eat 
except for meat, poultry, and processed egg products, which are 
regulated by our partners at USDA.
    Although FDA has the lead responsibility within HHS for ensuring 
the safety of food products, CDC has an important complementary and 
nonregulatory public health role. CDC is the lead Federal agency for 
conducting disease surveillance and outbreak investigation and 
routinely monitors the occurrence of specific illnesses in the United 
States attributable to the entire food supply. The disease surveillance 
systems coordinated by CDC, in collaboration with States, provide an 
essential early-information network to detect dangers in the food 
supply and to reduce foodborne illness. Two key surveillance components 
of our Nation's early information network are PulseNet and OutbreakNet. 
PulseNet is a national network of public health laboratories that 
perform DNA fingerprinting on foodborne bacteria that result in human 
illness. The PulseNet network permits rapid comparison of these 
fingerprint patterns through an electronic database at CDC. OutbreakNet 
is a network of public health epidemiologists who, under CDC's 
coordination, investigate suspected foodborne disease outbreaks to 
determine which foods may be involved and, thus, which control 
strategies may be needed. Both of these networks provided important 
information that led to the early detection of the recent outbreak. 
CDC's ability to detect and investigate outbreaks of foodborne illness 
through its networks enable CDC to alert FDA and USDA about implicated 
food products associated with foodborne illness. CDC also provides 
expert scientific evaluations of the effectiveness of foodborne disease 
prevention strategies.
    FDA contributes financially and scientifically to the Foodborne 
Diseases Active Surveillance Network (FoodNet), the principal foodborne 
disease component of CDC's Emerging Infections Program (EIP). FoodNet 
is a collaborative activity of CDC, FDA, the Food Safety and Inspection 
Service (FSIS) of USDA, and 10 EIP sites. Through this active 
surveillance system, these sites actively seek out information on 
foodborne illnesses identified by clinical laboratories, collect 
information from patients about their illnesses, and conduct 
investigations to determine which foods are linked to specific 
pathogens. This surveillance system provides important information 
about changes over time in the burden of foodborne diseases. For 
example, the CDC foodborne illness report I mentioned earlier used data 
from FoodNet to identify the decline in the incidence of specific 
foodborne illnesses. These data help public health and food safety 
agencies evaluate the effectiveness of current food safety initiatives 
and develop and plan future food safety activities to prevent and 
reduce emerging foodborne illnesses. My colleague here today from CDC 
will provide additional details about CDC's important public health 
programs.
    In addition to working closely with CDC, our sister public health 
agency, FDA has many other food safety partners--Federal, State, and 
local agencies; academia; and industry. The Government's response to 
the recent E. coli outbreak is a good example of the close and 
effective working relationships we enjoy with our food safety partners.

        RECENT E. COLI O157:H7 OUTBREAK LINKED TO FRESH SPINACH

    On the afternoon of September 13, CDC informed FDA of a multi-state 
foodborne illness outbreak, that appeared to be ongoing, of E. coli 
O157:H7 possibly associated with the consumption of fresh spinach. On 
September 14, CDC notified FDA that the epidemiological data confirmed 
that fresh spinach was implicated as the source of the illnesses. That 
day, FDA, CDC, and California and other State officials began holding 
daily conference calls to share information, coordinate efforts to 
contain the spread of the outbreak, and investigate the cause.
    Also that day, FDA's San Francisco District Office and California 
Department of Health Services' Food and Drug Branch hosted a conference 
call with three spinach-processing firms to advise them of the outbreak 
and to suggest that they consider the possible need to recall spinach 
products. We informed these firms that FDA would begin onsite 
investigations of processing facilities that day. FDA, in conjunction 
with the California Food and Drug Branch, also activated the California 
Food Emergency Response Team (CalFERT), a joint California and FDA 
response team to investigate the source of E. coli O157:H7 and 
determine the extent of possibly contaminated product.
    Once CDC notified FDA that they had confirmed that fresh spinach 
was the source of the outbreak, FDA immediately took action to prevent 
further illnesses by alerting consumers. On September 14, FDA held a 
press teleconference and issued a press release alerting consumers 
about the outbreak, stating that preliminary epidemiological evidence 
suggested that bagged fresh spinach may be the cause and advising 
consumers to avoid bagged fresh spinach. Over the course of the next 
few days, the advisory was expanded to include all fresh spinach to 
ensure that consumers could adequately avoid eating any tainted 
product. This revision to the initial advisory became necessary when we 
learned that bagged spinach was sometimes sold in an un-bagged form at 
the retail level. This revised advisory remained in effect until 
September 22, when we were confident that the source of the tainted 
spinach was restricted to the three implicated counties in California. 
At that time, we advised consumers that spinach from outside these 
counties was not implicated in the outbreak and could be consumed.
    During the outbreak, on an almost daily basis, FDA held press 
conferences (that included spokespersons from the State of California), 
issued press releases, and posted updates on our Website to limit the 
spread of the outbreak by keeping the public informed. FDA also worked 
closely with foreign government's food safety officials to provide them 
up-to-date information regarding the recall.
    FDA, the State of California, CDC, and the USDA continue to 
investigate the cause of the outbreak. The environmental and onsite 
investigation has included inspections and sample collection in 
facilities, the environment, and water. In addition, investigators have 
reviewed and evaluated animal management practices, water use, and the 
environmental conditions that could have led to contamination of the 
spinach. The field investigation team has included experts in multiple 
disciplines from FDA, CDC, USDA, and the State of California.
    The joint FDA/State of California field investigation found the 
same strain of E. coli O157:H7 as was involved in the illness outbreak 
in samples taken from a stream and from feces of cattle and wild pigs 
present on ranches implicated in the outbreak. The investigation team 
also found evidence that wild pigs have been in the spinach fields. We 
continue to look for more information as to the source and mechanism of 
contamination.

              FDA INITIATIVES TO ENHANCE SAFETY OF PRODUCE

    As I mentioned earlier, FDA continues to be concerned about the 
number of foodborne illness outbreaks associated with fresh produce. In 
the past decade, consumption of produce, particularly ``ready-to-eat'' 
products, has increased dramatically. These products are usually 
consumed in their raw state without processing to reduce or eliminate 
pathogens that may be present. Consequently, the manner in which they 
are grown, harvested, packed, processed, and distributed is crucial to 
ensuring that microbial contamination is minimized, thereby reducing 
the risk of illness to consumers.
    FDA has initiated several activities to address safety concerns 
associated with the production of fresh produce in response to the 
increase in illnesses associated with consumption of fresh produce. 
Some of these activities include: developing guidance, conducting 
outreach to consumers, sampling and analyzing both domestic and 
imported produce for pathogens, and working with industry to promote 
the use of good growing, harvesting, packing, transporting, and 
processing practices.
    In 1998, FDA and USDA issued guidance for industry, ``Guide to 
Minimize Microbial Food Safety Hazards for Fresh Fruits and 
Vegetables.'' This guidance, known as the Good Agricultural Practices 
(GAPs) guidance, addresses microbial food safety hazards and good 
agricultural and management practices common to the growing, 
harvesting, washing, sorting, packing, and transporting of most fruits 
and vegetables sold to consumers in an unprocessed or minimally 
processed (raw) form. FDA and USDA issued the guidance in several 
languages and have conducted significant outreach, both domestically 
and internationally, to encourage its implementation.
    After raw sprouts were associated with several outbreaks, FDA 
issued two guidance documents in 1999 for the sprout industry. The 
guidance documents contain steps that the sprout industry could use to 
reduce microbial hazards common to sprout production to ensure that 
sprouts are not a cause of foodborne illness. Implementation of the 
guidance has reduced the incidence of outbreaks of illness attributed 
to the consumption of sprouts.
    Since then, FDA has collaborated with industry, in cooperation with 
State agencies and academia, to develop commodity-specific supply chain 
guidance for the commodities most often associated with foodborne 
illness outbreaks. FDA contracted with the Institute of Food 
Technologists (IFT) to summarize scientific research relating to the 
various methods of eliminating or reducing pathogens on whole and 
fresh-cut produce. The 2001 report generated as part of the contract 
with IFT provided important information that we used to plan and 
develop future produce safety activities.
    In October 2004, FDA announced its Produce Safety Action Plan to 
help reduce the incidence of foodborne illness attributed to the 
consumption of produce. The Action Plan has the following four 
objectives: (1) preventing contamination of fresh produce with 
pathogens; (2) minimizing the public health impact when contamination 
of fresh produce occurs; (3) improving communications with producers, 
preparers and consumers about fresh produce safety; and (4) 
facilitating and supporting research relevant to fresh produce. This 
Plan represents the first time that FDA had developed a comprehensive 
food safety strategy specific to produce.
    Since 2005, as part of the Produce Safety Action Plan, FDA has 
provided technical assistance to industry in developing guidance for 
five commodity groups: cantaloupes, lettuce and leafy greens, tomatoes, 
green onions, and herbs. These commodities account for more than 80 
percent of the foodborne outbreaks associated with produce. Three of 
the guidance documents (for cantaloupes, tomatoes, and lettuce and 
leafy greens) have been completed. We have recently made these guidance 
documents available, and FDA has done outreach and training with the 
industry to implement the guidance. FDA is still working on the 
commodity-specific guidance for herbs and green onions. In March of 
this year, we released draft guidance for the fresh-cut produce 
industry, ``Draft Guide to Minimize Microbial Food Safety Hazards of 
Fresh-cut Fruits and Vegetables.'' We are currently working to finalize 
this guidance document.
    In August 2006, FDA met with Virginia officials to discuss 
outbreaks associated with tomatoes produced on the eastern shore of 
Virginia. FDA is working with the Florida Tomato Exchange and the 
University of Florida's Institute of Food and Agricultural Sciences to 
arrange a forum to discuss ways to improve the safety of tomatoes. The 
preliminary plan is for the forum to include FDA, State officials 
including Commissioners of Agriculture and Secretaries of Health, as 
well as representatives from institutions and industry in several 
selected States. Once our investigation of the recent Salmonella 
Typhimurium outbreak linked to fresh tomatoes served in restaurants is 
complete, we will also re-examine the need for additional safety 
measures to ensure tomato safety.
    We also are working in a broader context to address food safety 
concerns for all leafy greens. In the past 2 years, FDA twice wrote to 
industry to express FDA's concerns with continuing illness outbreaks 
and to express our expectations for industry to enhance the safety of 
these products. These letters were a ``Notice to Firms that Grow, Pack, 
or Ship Fresh Lettuce and Fresh Tomatoes'' sent in February 2004 and a 
``Letter to California Firms that Grow, Pack, Process, or Ship Fresh 
and Fresh-cut Lettuce'' (and leafy greens) sent in November 2005.
    More recently, in August 2006, FDA and the State of California 
launched the Lettuce Safety Initiative at the ``Forum for Discussion of 
Lettuce Safety,'' hosted by the Western Institute for Food Safety and 
Security (WIFSS). This initiative was developed as a response to the 
recurring outbreaks of E. coli O157:H7 associated with fresh and fresh-
cut lettuce and leafy greens, primarily, but not exclusively, from the 
Salinas Valley area. The multiyear initiative is intended to reduce 
public health risks by focusing on the product, agents, and areas of 
greatest concern. The four objectives of the proactive initiative are 
to: (1) assess current industry approaches and actions to address the 
issue of improving lettuce safety and, if appropriate, stimulate 
segments of the industry to further advance efforts in addressing all 
aspects of improving lettuce safety; (2) alert consumers early and 
respond rapidly in the event of an outbreak; (3) obtain information for 
use in developing and/or refining guidance and policy that will 
minimize future outbreaks; and (4) consider regulatory action, if 
appropriate.
    Through its investigations of farms implicated in previous 
outbreaks, FDA has identified many possible factors that contribute to 
the contamination of fresh produce. These factors include the exposure 
of produce to poor quality water, manure used for fertilizer, workers 
with poor hygiene, and animals, both domesticated and wild, on the 
farm. FDA has been working with the State of California and the 
industry to promote the adoption of measures to prevent contamination 
of fresh produce.

                               NEXT STEPS

    In view of this recent E. coli O157:H7 outbreak, and after 
discussions with industry, FDA and the State of California advised the 
industry to develop a plan to minimize the risk of another outbreak in 
all leafy greens, including lettuce. Once we have completed our current 
investigation, FDA will hold a public meeting to address the larger 
issue of foodborne illness linked to leafy greens. We will also be 
examining whether improvements in the following four areas could help 
prevent or contain future outbreaks: (1) strategies to prevent 
contamination; (2) ways to minimize the health impact after an 
occurrence; (3) ways to improve communication; and (4) specific 
research. We also will be holding a series of meetings with industry 
groups to discuss ways to improve the safety of fresh produce. As part 
of our evaluation, we will consider whether additional guidance and/or 
additional regulations are necessary.
    As we continue to look for a better path to improving the safety of 
fresh produce, research will remain a critical element. This element of 
a critical path to safer foods will need to include research on 
analytical technologies that enable faster detection of foodborne 
pathogens and better intervention strategies. Our current research 
agenda is focused on improving the identification and detection of 
disease-causing bacteria and toxins in a variety of foods. More rapid 
and precise testing methods are important to minimizing the spread of 
foodborne disease once it occurs. We are also studying possible 
intervention strategies, such as use of thermal treatment and 
irradiation, which could be applied to fresh produce products to reduce 
the level of bacteria and viruses that are in or on the product.
    In addition, we are working with universities, industry, and State 
governments to develop both risk-based microbiological research 
programs and technology transfer programs to ensure that the latest 
food technology reaches the appropriate end users along the supply 
chain. We will continue to work with these partners to develop 
guidance, conduct research, produce educational outreach documents, and 
to initiate other commodity- or region-specific programs that will 
enhance the safety of fresh produce.

                               CONCLUSION

    In conclusion, FDA is working hard, in collaboration with its 
Federal, State, local, and international food safety partners and with 
industry, consumers, and academia, to improve the safety of fresh 
produce. As a result of this effective collaboration, the American food 
supply continues to be among the safest in the world. This year's 
report of FoodNet data clearly shows that the preventive measures being 
implemented by FDA, USDA, and others are achieving significant public 
health outcomes in the effort to reduce the incidence of foodborne 
illness. We have made significant progress but will continue to strive 
to reduce the incidence of foodborne illness to the lowest level 
possible.
    Thank you for the opportunity to discuss FDA's food safety 
programs. I would be happy to answer any questions.

    The Chairman. Thank you, Dr. Brackett.
    Dr. King.

STATEMENT OF DR. LONNIE KING, SENIOR VETERINARIAN, CENTERS FOR 
          DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. King. Thank you, Chairman Enzi and Senator Burr. Good 
afternoon. I am pleased to be here to discuss CDC's activities 
related to foodborne illness and our role in the response to 
the recent outbreak of E. coli infections associated with fresh 
spinach.
    Many people do not think about food safety until food-
related illness affects them or a member of their family. The 
Chairman talked about the estimates that CDC has, of 76 million 
people getting sick every year, more than 300,000 
hospitalizations and perhaps as many as 5,000 deaths each year 
due to foodborne illness. So preventing foodborne illness 
remains a major public health challenge.
    CDC leads Federal efforts to gather data on foodborne 
illnesses, to investigate illnesses and outbreaks and monitor 
the effectiveness of prevention and controls efforts. CDC is 
not a food safety regulatory agency but it works closely with 
our regulatory colleagues and in particular with the FDA and 
the USDA. CDC also plays a key role in identifying prevention 
strategies, building State and local health departments and 
supporting epidemiology, laboratory in an environmental health 
capacity in order to support foodborne illness surveillance and 
outbreak response.
    Notably, CDC data are used to help document the 
effectiveness of regulatory interventions and to develop new 
preventive strategies.
    Routine disease surveillance systems coordinated by CDC 
provide an essential early information network to detect 
potential threats to our public's health. These systems can be 
used to indicate new or changing patterns of foodborne illness. 
For example, PulseNet is the national network for DNA 
fingerprinting of foodborne bacteria, which was developed in 
collaboration with the Association of Public Health 
Laboratories and is coordinated by the CDC. The laboratories 
participating in PulseNet are in the State health departments 
and some local health departments.
    PulseNet plays a vital role in surveillance for 
investigations of foodborne illness outbreaks that were 
previously very difficult or impossible to detect. The strength 
of this system is its ability to rapidly detect a cluster of 
infections and identify DNA patterns, even if the infected 
persons are geographically far away, as we saw in this 
outbreak. It is very important to have this mechanism, given 
the reality of our foodborne distribution systems today.
    During the recent E. coli outbreak related to spinach, 
PulseNet was critical to identifying this outbreak. In early 
September, PulseNet showed that the DNA patterns in clusters in 
Wisconsin and Oregon were identical and that other States 
reported cases with the same PulseNet pattern among ill persons 
who had also eaten fresh spinach. Rapid collection of standard 
case exposure information by epidemiologists in these affected 
States and the sharing of exposure information among States and 
the CDC led to the rapid identification of the suspected food 
source and a public health action.
    Quick sharing of information among the States, CDC and FDA 
led to a warning to the public on September 14, not to eat 
fresh bagged spinach. Coordination with the FDA was essential 
for investigating this outbreak. Frequent conference calls 
relayed the data on spinach purchases and sources through FDA, 
guiding and helping with the ongoing investigation. At FDA's 
request, an experienced hydrologist from CDC's National Center 
for Environmental Health, was deployed to California to join 
the FDA and the California Food Emergency Response Team in the 
investigation of possible environmental sources of 
contamination that led to this outbreak.
    To ensure that the information was disseminated to the 
public as accurately and quickly as possible about the health 
threats and other information related to this outbreak, CDC and 
the FDA coordinated their communications strategies and their 
messages, discussed these strategies in daily conference calls 
and also included State health officials.
    CDC's daily posting of case updates ended on October 6 when 
it was clear that the outbreak was over, although PulseNet 
continues to monitor the frequency of this pattern of E. coli 
O157 infections.
    In conclusion, this event and the more recent salmonella 
outbreak related to tomatoes illustrates how large and 
widespread outbreaks can occur, appearing first as a small 
cluster and then rapidly increasing if a popular commercial 
product has been contaminated. It also illustrates the 
importance of existing public health networks, the laboratories 
performing PulseNet finger-
printing, and the epidemiologists, who interview patients and 
look at healthy people and make the comparisons and collect 
leftover produce. The multidisciplinary approach needed for 
such investigations and the close communication and 
collaboration among local, State and Federal officials, without 
question, a rapid and action analysis of and response to an 
outbreak will result in the prevention of exposure to 
contaminated products and will stop further illness and death, 
which happened in this case. Produce-related outbreaks are a 
growing challenge to public health as the E. coli and other 
outbreaks indicate. Research should focus on tracing the 
specific pathways that connect fields of leafy green vegetables 
with potential animal reservoirs of E. coli and other disease-
causing microbes.
    CDC is prepared to continue working with regulatory 
authorities, food and environmental microbiologists and the 
food industry to find long-term solutions to this very 
challenging problem. Thank you for highlighting this very 
important public health issue and Dr. Chris Braden and I are 
very happy to answer any questions you might have.
    [The prepared statement of Dr. King follows:]

              Prepared Statement of Lonnie J. King, D.V.M.

                              INTRODUCTION

    Good afternoon, Chairman Enzi and members of the subcommittee. I am 
Lonnie King, the Centers for Disease Control and Prevention's (CDC) 
senior veterinarian, and I am leading the effort to form a new center 
at CDC focusing on zoonotic, 
vector-borne, and enteric diseases, which includes CDC's foodborne 
illness-related activities. Accompanying me today is Dr. Chris Braden, 
Chief of the Outbreak Response and Surveillance Team for our foodborne 
illness activities. Thank you for the invitation to address the 
subcommittee on CDC's activities related to foodborne illness in 
general and on CDC's role in the response to the recent outbreak of E. 
coli infections associated with fresh spinach.

                               BACKGROUND

    Many people do not think about food safety until a food-related 
illness affects them or a family member. CDC estimates that 76 million 
people get sick, more than 300,000 are hospitalized, and 5,000 
Americans die each year from foodborne illness. Preventing foodborne 
illness remains a major public health challenge.
    More than 250 different foodborne illnesses have been described in 
scientific literature. Most of these diseases are caused by a variety 
of bacteria, viruses, and parasites. Some foodborne illnesses are 
poisonings, caused by harmful toxins or chemicals that have 
contaminated the food such as those found in poisonous mushrooms. These 
various illnesses have many different clinical signs, and therefore 
they cannot be characterized as one foodborne illness ``syndrome.''
    Microbes spread in a variety of ways, so it is not always certain 
that an identified illness is caused by food. In order to prevent and 
control illness, public health authorities need to determine how a 
particular disease is spreading. For example, Escherichia coli (E. 
coli) O157:H7 infections can spread through contaminated food, contact 
with infected petting zoo animals, contaminated swimming water, and 
from toddler to toddler at a childcare center. Depending on 
transmission routes, the measures to stop other cases from occurring 
might involve removing contaminated food from stores, chlorinating a 
swimming pool, or closing a childcare center. By conducting a rapid 
investigation, epidemiologists and laboratorians can determine the 
source of an outbreak and recommend immediate measures to control it. 
Detailed investigations into how contamination occurs are critical to 
developing strategies to prevent similar outbreaks in the future.
    Many foodborne infections occur separately without obvious 
connection to other cases. These are called sporadic cases. Determining 
the source of a single sporadic case can be very difficult. Cases of 
similar infections can also occur as a group or ``cluster.'' 
Epidemiological investigation of clusters of possibly related cases 
permits public health officials to determine if the cases are linked to 
food, which is the first step in preventing further illnesses. An 
outbreak of foodborne illness is considered a cluster if two or more 
infections caused by the same agent (pathogen or toxin) are linked to 
the same food upon investigation. Roughly 1,200 foodborne outbreak 
investigations are reported to CDC each year. CDC works closely with 
local and State health departments to investigate foodborne disease 
outbreaks and make information available to the public.
    Produce-related outbreaks such as the recent outbreak associated 
with raw spinach have become larger and more common. For example, in 
the 1970s, foodborne outbreaks related to produce accounted for less 
than 1 percent of outbreaks with a known food source. By the end of the 
1990s, they accounted for 6 percent of these outbreaks.

               CDC'S ROLE IN PREVENTING FOODBORNE ILLNESS

    As an agency within the Department of Health and Human Services 
(HHS), CDC leads Federal efforts to gather data on foodborne illnesses, 
investigate foodborne illnesses and outbreaks, and monitor the 
effectiveness of prevention and control efforts. CDC is not a food 
safety regulatory agency but works closely with the food safety 
regulatory agencies, in particular with HHS's Food and Drug 
Administration (FDA) and the Food Safety and Inspection Service within 
the U.S. Department of Agriculture (USDA). CDC also plays a key role in 
identifying prevention strategies and building State and local health 
department epidemiology, laboratory, and environmental health capacity 
to support foodborne disease surveillance and outbreak response. 
Notably, CDC data are used to help document the effectiveness of 
regulatory interventions.
    In partnership with State health departments, CDC collects 
surveillance information on foodborne illness. The States collect data 
about cases of infections that are of public health importance from 
doctors and clinical laboratories. CDC helps States investigate 
outbreaks that are large, severe, or unusual. When a new problem 
emerges, as happened in 1982 when E. coli O157 was first recognized as 
a cause of human illness, CDC conducts practical research to determine 
the best diagnostic methods and to define the source of the illness.
    To initially make a diagnosis, a patient must seek medical 
attention, the physician must decide to order diagnostic tests, and the 
laboratory must use the appropriate procedures. Many ill people do not 
seek medical attention, and of those who do, many are not tested. 
Therefore, many cases of foodborne illness go undiagnosed and are not 
reported. For example, CDC estimates that 38 cases of salmonellosis 
occur for every case that is actually reported to CDC. Some foodborne 
infections are not identified by routine laboratory procedures and 
require specialized, experimental, and/or expensive tests that are not 
generally available. When there is an outbreak of illness and routine 
testing does not identify the microbe or other causes, samples from the 
patients may be sent to the State public health laboratory or to CDC 
for more specialized testing. Less than half of all foodborne outbreaks 
have known causes or etiology.

Surveillance and Epidemiology
    CDC specializes in the critically important public health 
activities of surveillance, epidemiologic response, and investigation 
of disease. Routine disease surveillance systems coordinated by CDC, 
combined with CDC epidemiology offices and laboratories provide an 
essential early-information network to detect potential threats to the 
public in the food supply. These systems can be used to indicate new or 
changing patterns of foodborne illness.
    In 1993, there was a large multi-state outbreak of E. coli O157 
infections in the Western United States. In order to prevent future 
severe outbreaks by enabling rapid comparison of bacteria isolated from 
ill persons around the country, an effective surveillance network 
called PulseNet was developed. PulseNet is the national network for 
molecular subtyping of foodborne bacteria, which was developed in 
collaboration with the Association of Public Health Laboratories (APHL) 
and is coordinated by CDC. The laboratories participating in PulseNet 
are in State health departments, some local health departments, USDA, 
and FDA. PulseNet plays a vital role in surveillance for and 
investigation of foodborne illness outbreaks that were previously 
difficult to detect. For example, when a clinical laboratory diagnoses 
E. coli O157 is made in a patient, that bacterial strain is sent to the 
participating PulseNet laboratory where it is subtyped, or ``DNA 
fingerprinted.'' The ``fingerprint'' is then compared with other 
patterns in the State, and uploaded electronically to the national 
PulseNet database maintained at CDC, where it can be compared with the 
patterns in other States. This gives us the capability to rapidly 
detect a cluster of infections with the same pattern that is occurring 
in multiple States. The PulseNet database, which includes approximately 
120,000 DNA patterns, is available to participating laboratories and 
allows them to rapidly compare patterns. Once a cluster of cases with 
the same DNA pattern is identified, epidemiologists then interview 
patients to determine whether cases of illness are linked to the same 
food source or other exposures they have in common. The strength of 
this system is its ability to identify patterns even if the affected 
persons are geographically far apart, which is important given the 
reality of U.S. food distribution systems. If patients have been 
exposed to a specific food or to another source of infection and the 
case count for that illness is larger than one would expect for the 
time period, the cluster is determined to be an outbreak with a common 
source.
    The group of epidemiologists in the States and at CDC who regularly 
investigate and report on these outbreaks is called OutbreakNet. The 
OutbreakNet participants use standardized interview methods and forms 
and rapidly share the investigation data. With this collaboration, 
outbreaks can be investigated in a matter of days rather than weeks. As 
a consequence, CDC can more rapidly alert FDA and USDA about implicated 
food products associated with foodborne illness so that all three 
agencies can collaboratively take actions to protect public health. 
Tracing the implicated food back from consumption through preparation, 
to distributors, and sometimes back to a field or farm can help 
determine how the contamination occurred, stop distribution of the 
contaminated product, and prevent further outbreaks from occurring. 
OutbreakNet and CDC's overall efforts to continuously improve methods 
and to train epidemiologists, laboratorians, and environmental health 
specialists are making investigations of outbreaks faster and more 
likely to identify the source. With this enhanced capacity, the public 
health system can rapidly identify implicated foods with precision and 
minimize the impact of the outbreak.
    Another important surveillance network is CDC's Foodborne Diseases 
Active Surveillance Network (FoodNet). This network is a collaboration 
among 10 State health departments, USDA, and FDA that closely monitors 
the human health burden of foodborne diseases in the United States. It 
produces reliable estimates of the burden and trends over time for 
foodborne infections of public health importance. In the participating 
sites, FoodNet conducts active surveillance for foodborne diseases and 
also conducts related epidemiologic studies that look at sporadic and 
outbreak foodborne infections to help public health officials better 
understand the epidemiology of foodborne diseases in the United States 
and how to target prevention strategies. We have PulseNet to detect 
possible outbreaks, OutbreakNet to investigate and report them, and 
FoodNet to track general trends and define where more effective 
prevention strategies are needed.
    These networks stand prepared to detect a public health event 
related to the food supply. For example, after investigations of 
PulseNet-identified clusters of E. coli infection focused attention on 
the need for specific controls during ground beef processing, 
regulatory and industry practices changed in 2002, and the incidence of 
E. coli O157 infections began to decrease sharply. By 2005, the 
incidence of E. coli O157 infections as measured in FoodNet had dropped 
29 percent since the baseline period of 1996-1998, which very nearly 
met the goal for Healthy People 2010. During the same time period, the 
occurrence of Listeria infections decreased by 32 percent.
    In 2000, in collaboration with FDA and eight States (California, 
Colorado, Connecticut, Georgia, Minnesota, New York, Oregon, and 
Tennessee), CDC established the Environmental Health Specialists 
Network (EHS-Net). The purpose of EHS-Net is to assist State health 
departments in their efforts to improve the practice of environmental 
health service programs. EHS-Net is a collaborative forum of 
environmental health specialists (EHSs), epidemiologists, and 
laboratorians who work to identify and prevent environmental factors 
contributing to foodborne and water-borne disease outbreaks.
    EHS-Net has been instrumental in characterizing policies and 
practices of retail foodservice establishments associated with 
foodborne outbreaks. For instance, a recent EHS-Net study found that 
food safety certification of kitchen managers in restaurants appears to 
be an important foodborne outbreak prevention measure. The EHS-Net also 
studies policies and practices of retail foodservice establishments in 
handling specific foods that have been associated with past foodborne 
outbreaks. Studies such as these provide regulators with the science-
based practical research necessary for adopting recommended practices 
and for developing new or evaluating existing foodborne disease 
prevention measures.

CDC Goals
    CDC is adapting to meet 21st century health and safety threats. New 
strategies, innovations, and goals bring new focus to the agency's 
work, allowing CDC to do even more to protect and improve health. CDC 
has developed four major overarching goals, all of which specifically 
involve foodborne illness-related activities: Healthy People in Every 
Stage of Life, Healthy People in Healthy Places, Healthy People in a 
Healthy World, and People Prepared for Emerging Health Threats. In 
addition to the efforts previously described, activities that 
contribute to these overarching goals include working with physicians 
and clinical labs to promote proper diagnosis and treatment; educating 
consumers and promoting safe food practices in homes, restaurants, and 
institutions; monitoring antimicrobial resistance among microbes that 
can cause foodborne illness; and enhancing public health networks to 
detect and respond to outbreaks faster.

      CDC'S ROLE IN THE RECENT E. COLI OUTBREAK RELATED TO SPINACH

    On Friday, September 8, 2006, CDC officials were alerted by 
epidemiologists in Wisconsin of a small cluster of E. coli serotype 
O157:H7 infections of unknown source. Wisconsin also posted the ``DNA 
Fingerprint'' pattern of the cluster to PulseNet, thus alerting the 
entire network. Separately, the State health department of Oregon also 
noted a very small cluster of infections that day and began 
interviewing the cases. On September 13, both Wisconsin and Oregon 
reported to CDC that initial interviews suggested that eating fresh 
spinach was commonly reported by cases in both clusters of E. coli 
serotype O157:H7 infections in those States. PulseNet showed that the 
patterns in the two clusters were identical, and other States reported 
cases with the same PulseNet pattern among ill persons who also had 
eaten fresh spinach. CDC notified FDA about the Wisconsin and Oregon 
cases and the possible link with bagged fresh spinach. CDC and FDA 
convened a conference call on September 14 to discuss the outbreak with 
the States.
    Quick sharing of information among the States, CDC, and FDA led to 
FDA warning the public on September 14 not to eat fresh bagged spinach. 
On September 15, as the number of reported cases approached 100, CDC 
activated its Director's Emergency Operations Center (DEOC), which 
provided a facility conducive to an intensive team effort. Working in 
the DEOC improved coordination for daily inter-agency calls, for 
numerous calls among FDA, CDC, and the States, and for communication 
activities.
    The epidemiological phase of the E. coli O157 outbreak response was 
composed principally of CDC and State PulseNet and OutbreakNet Team 
members. Cases were identified by PulseNet and interviewed in detail by 
members of OutbreakNet. Leftover spinach was cultured at CDC, FDA, and 
in State public health laboratories. CDC and FDA also collaborated on 
updated analytical methods and provided reagents to State laboratories. 
The epidemiologic investigation indicated that the outbreak was 
associated with bagged spinach produced under multiple labels in a 
single plant on a single day during a single shift. CDC also worked 
with teams in Wisconsin, Utah, and New Mexico to conduct a formal case-
control study, which was useful in confirming that the risk was 
associated with one processing plant.
    Coordination with FDA was essential for investigating the outbreak. 
Frequent conference calls relayed the data on spinach purchases and 
sources to FDA, guiding the ongoing investigation of possible 
production sites of interest. At FDA's request, an experienced 
hydrologist from CDC's National Center for Environmental Health was 
deployed to California to join FDA and the California Food Emergency 
Response Team in the investigation of possible environmental sources of 
contamination that led to this outbreak. To ensure that information was 
disseminated to the public as accurately and quickly as possible about 
health threats and other information related to this outbreak, CDC and 
FDA coordinated their communication strategies and messages and 
discussed these strategies in daily calls with State health officials. 
CDC utilized its Emergency Communication System, part of its DEOC, to 
coordinate internal and external communications, such as press 
releases, teleconferences, and web postings.
    CDC also provided information via the Health Alert Network (HAN) 
Messaging System, disseminating updates directly or indirectly to over 
1 million individuals including State and local health officers, public 
information officers, and others.
    CDC's daily posting of case updates ended on October 6 when it was 
clear that the outbreak was over, although PulseNet continues to 
monitor the frequency of this pattern among all diagnosed E. coli O157 
infections. Between August 1 and October 6, a total of 199 persons 
infected with the outbreak strain of E. coli O157:H7 were reported to 
CDC from 26 States. Among the ill persons, 102 were hospitalized, 31 
had hemolytic uremic syndrome which can lead to kidney failure (HUS), 
and three persons died. Eighty-five percent of patients reported 
illness onset from August 19 to September 5. Among the 130 patients for 
which a food consumption history was collected, 123 (95 percent) 
reported consuming uncooked fresh spinach during the 10 days before 
illness onset. In addition, E. coli O157:H7 with a DNA ``fingerprint'' 
pattern matching the outbreak strain was isolated from 11 open packages 
of fresh spinach that had been partially consumed by patients.
    For this investigation, a confirmed case was defined as a culture-
confirmed E. coli O157:H7 infection in a person residing in the United 
States, with illness onset from August 1 to October 6 (or, if date of 
onset was unknown, E. coli O157:H7 isolated from August 1 to October 6) 
and a PulseNet ``fingerprint'' pattern identified by the Xbal 
restriction enzyme that matched the pattern of the outbreak strain. 
August 1 was selected as the earliest illness onset date in the case 
definition to ensure that the earliest cases in the outbreak were 
identified and investigated. However, the first six confirmed cases 
(with illness onsets during August 2-15) were in persons who did not 
report eating fresh spinach during the week before illness onset. The 
first person who reported recently eating fresh spinach and had 
infection with the outbreak strain fell ill on August 19. Thus, August 
19 marked the effective beginning of the outbreak.
    This outbreak strain of E. coli O157:H7 is one of 3,520 different 
E. coli O157:H7 patterns reported to CDC PulseNet since 1996. 
Infections with this strain have been reported sporadically to CDC's 
PulseNet since 2003, at an average of 21 cases per year from 2003 to 
2005. This finding suggests that this strain has been present in the 
environment and food supply occasionally, although it had not been 
associated with a recognized outbreak in the past.
    The time from illness onset to confirmation that a case of E. coli 
O157:H7 is part of an outbreak is typically 2-3 weeks, including the 
time required for an infected person to seek medical care, for 
healthcare providers to obtain a diagnostic culture, transfer the 
bacterial strain to a public health laboratory, perform ``DNA 
fingerprinting,'' and submit the ``fingerprint'' pattern into the 
national PulseNet database at CDC. In this outbreak, the average time 
from illness onset to DNA pattern submission to the national database 
at CDC was 15 days.
    Parallel laboratory and epidemiologic investigations were crucial 
in identifying the source of this outbreak. Timely PulseNet 
``fingerprinting'' by State public health laboratories, ``fingerprint'' 
pattern submission by States to the PulseNet database at CDC, and 
analysis of ``fingerprint'' patterns in the CDC PulseNet national 
database resulted in rapid detection of the outbreak. Rapid collection 
of standard case exposure information by OutbreakNet epidemiologists in 
affected States and sharing of exposure information among States and 
CDC led to rapid identification of the suspected food source and public 
health action.

                COLLABORATIONS WITH FOOD SAFETY PARTNERS

Council to Improve Foodborne Outbreak Response
    The epidemiology of foodborne and diarrheal diseases is always 
changing, the result of changing diagnostic and subtyping capabilities 
in laboratories, newly recognized and emerging pathogens, changes in 
food production, distribution, processing, and consumption patterns, 
demographic shifts, and many other factors. To successfully manage 
foodborne outbreak challenges, public health agencies must constantly 
adapt. The Council to Improve Foodborne Outbreak Response (CIFOR) was 
created to help develop model programs and processes that will 
facilitate the investigation and control of foodborne disease 
outbreaks. CIFOR's agenda includes improving the performance and 
coordination of relevant local, State, and Federal public health 
agencies involved in epidemiology, environmental health, laboratory 
sciences, and regulatory affairs. CIFOR, co-chaired by the Council of 
State and Territorial Epidemiologists (CSTE) and the National 
Association of County and City Health Officials (NACCHO), will develop 
multi-state outbreak guidelines, a repository for resources and tools, 
and performance measures for response to enteric illness. CIFOR 
includes representatives from CDC, FDA, USDA, CSTE, NACCHO, APHL, the 
Association of State and Territorial Health Officials, National 
Environmental Health Association, and the Association of Food and Drug 
Officials.

Council of Association Presidents
    Integrating the food safety and food defense efforts of Federal, 
State, and local public health, veterinary and food safety officials is 
of critical importance. CDC is collaborating with FDA, USDA, and the 
Council of Association Presidents to raise awareness of current and 
emerging issues and to promote coordination. The Council comprises the 
10 leading public health, veterinary, and food safety associations that 
work the spectrum of food safety and food defense, from animal feed to 
human health. The collective expertise and collaboration of these 
associations are essential to develop and implement integrated efforts, 
provide needed training, and build the multidisciplinary capacity 
necessary to address food-related emergencies.

                               CONCLUSION

    The recent outbreak of E. coli O157 infections related to spinach 
was large and deadly. Although the overall number of infections caused 
by this organism has decreased in recent years as the safety of meat 
has improved, this outbreak illustrates that better control and 
prevention measures are needed in other sectors of the food industry 
before we can consider E. coli O157 under adequate control. Although 
spinach has not been a source of E. coli O157 outbreaks before, lettuce 
has been implicated on several occasions. In fact, there have been 20 
outbreaks involving leafy greens, 7 of which were traced to California. 
A better understanding is needed of the mechanisms by which leafy 
greens become contaminated so contamination can be interrupted.
    The event illustrates how a large and widespread outbreak can 
occur, appearing first as small clusters, and then rapidly increasing 
if a popular commercial product is contaminated. It also illustrates 
the importance of existing public health networks: the laboratories 
performing PulseNet ``fingerprinting''; the epidemiologists 
interviewing patients and healthy people and collecting leftover 
spinach; the multidisciplinary approach to the investigation; and the 
close communication and collaboration among local, State, and Federal 
officials. This investigation illustrates what a robust public health 
system can do and lays down a benchmark for the future. Without 
question, a rapid and accurate analysis of and response to an outbreak 
will result in prevention of exposure to contaminated products and will 
stop further illness and death.
    Produce-related outbreaks are a growing challenge to public health. 
As this and other outbreaks indicate, research should focus on tracing 
the specific pathways that connect fields of leafy green vegetables 
with potential animal reservoirs of E. coli and other disease-causing 
microbes. CDC is prepared to continue working with regulatory 
authorities, food and environmental microbiologist scientists, and the 
food industry to find long-term solutions to this challenging problem.

    The Chairman. Thank you very much. We do appreciate your 
being here today. We appreciate the information that you 
shared. We, in the United States, take a lot of things for 
granted and one of those is our fresh produce. I know from 
going to other countries that most of the time, you're briefed 
and told, don't eat any vegetables and a lot of that has to do 
with the water, which is another thing we're fortunate on here 
in the United States. You can drink the water here.
    But we want it to be safer yet. We want to find the best 
ways to handle all of this, the best ways to get coordination, 
the best ways to make sure that our system works and people are 
as secure as possible.
    Dr. Brackett, has the FDA discovered any previously unknown 
weaknesses in the food safety system as a result of this event? 
Are there lessons from this incident that can be used to 
improve FDA's ability to respond to an intentional 
contamination of the food supply as opposed to an accidental 
one?
    Dr. Brackett. Well, thank you, Chairman Enzi. We've 
probably learned more from this particular outbreak than we had 
learned from all the previous outbreaks combined and there are 
many different lessons learned that we'll accumulate from this. 
The investigation is still ongoing and once it's done, we hope 
to catalog those lessons learned and use those in the future.
    But to your last point, as far as intentional, I have to 
say that we believe that the response that happened once we 
learned what the illness was caused from, was about as fast and 
as efficient as we could have possibly hoped. We were able to 
communicate very well with CDC as well as with the States and 
actually with USDA as well, to try to first of all isolate the 
product in the minds of consumers so that they could avoid 
that. Second, also initiate the investigation immediately so 
that we could find out what the cause was.
    The Chairman. Thank you. Dr. King, you indicated in your 
testimony that data from the outbreak was posted to PulseNet on 
September 8 but Dr. Reilly states that California didn't know 
about the outbreak until nearly a week later, on September 14 
when it was announced publicly. Can you explain what happened? 
What is the discrepancy or what was going on?
    Dr. King. I'm not quite sure of the discrepancy. I know on 
September 8, the Wisconsin Public Health Laboratory posted a 
PulseNet web-board messaging to all the States about this E. 
coli outbreak and about the matches that they say in the DNA 
fingerprinting. So that was available. It was later sent to 
CDC, to our national database. It was September 11 when CDC 
actually confirmed that. So the information was available from 
the State on September 8. It came to us, we did the 
confirmation on September 11.
    The Chairman. OK. Dr. Brackett again, some people use the 
outbreaks as evidence that the Food and Drug Administration 
needs mandatory recall authority. Has a company ever not agreed 
to voluntarily recall a product associated with an outbreak 
when asked by the FDA?
    Dr. Brackett. Not to my knowledge, that has not happened. 
Sometimes there have been a few cases where they may have 
balked but they've always done the right thing, which is to 
recall the product. In this particular case, the company, once 
they were notified, immediately recalled their product.
    The Chairman. Thank you. Back to you again, Dr. King. The 
CDC conducts a lot of pathogen testing and surveillance of 
food-
borne illnesses. What are the gaps in the ability to do the 
sort of testing and surveillance that need to be filled to 
protect consumers and is there a way that we can shorten the 
timeframe?
    Dr. King. Yes, it's the same as some of the lessons learned 
that Dr. Brackett talked about. I think first of all, we 
understand that prevention is better than tracing these 
outbreaks after the event has happened. Compression time is 
really important because a few days can make a big difference 
in terms of potential contamination of people. So we have 
continued to look at ways of how to compress time.
    There is a built-in timeframe that's necessary to report 
these. When a person eats some food that is contaminated, until 
he or she actually has signs of that disease--if he or she goes 
to a physician, if samples are taken, if cultures are then 
grown, if those cultures from clinical laboratories then have 
to be transported to the State public health laboratory to do 
the PulseNet and then transferred to CDC.
    In this case, it was 15 days between a case of illness and 
actually PulseNet confirmation at CDC. We think there are ways 
to probably compress that time. Quicker movement through the 
system in terms of moving cultures from commercial labs to the 
State lab, for State labs to actually put this up for us to 
identify can save a few days.
    But also, investigating this time and our working and 
looking at a brand, new diagnostic technology and that is, to 
move from PulseNet the DNA fingerprinting, if you will, to more 
looking at the genome of the microbe. That will actually 
compress time, make it faster, make it more accurate, make it 
more amenable to working with large databases because you're 
actually looking at the genome and amino acid strains.
    We believe that this will increase the amount of time, or 
decrease the amount of time, if you will, and also give us 
actually more accurate diagnosis. So we are actually working on 
that and that will probably be the next generation of 
diagnostics.
    The Chairman. Can you give me a little indication of how 
long it takes to grow a culture and also to do the DNA testing?
    Dr. King. Sure. I'm just going to give you some idea. In 
this case, from when a person was infected or ate the 
contaminated spinach in this case, it was about a 48-hour 
timeframe for that incubation period. That patient then goes in 
to a physician's office or a healthcare worker's office and is 
identified. In this case, because it is E. coli, there are very 
serious clinical cases with often hemorrhagic diarrheas and 
this particular strain was a pretty virulent strain.
    There is the time of treatment. Usually stool samples are 
taken and there is anywhere from 1 to 5 days for that to 
happen. The cultures are grown from 1 to 3 days. Once the E. 
coli had been identified, there is also a shipping time that 
goes from a clinical laboratory, which are often private labs, 
to the State lab and that can be anywhere from almost immediate 
to a week. Then anywhere from 1 to 4 days to get to CDC. So you 
can see where some of the compression could take place.
    The Chairman. Thank you. I'll now turn it over for 
questioning to our expert in this area, Senator Burr.
    Senator Burr. Thank you, Mr. Chairman. Doctors, welcome. 
Let me go back through some of the dates if I can. I'm having a 
tough time putting these things together. In the written 
testimony, Dr. King, I think you said CDC officials first heard 
about the E. coli outbreak by epidemiologists from Wisconsin on 
Friday, September 8. Is that correct?
    Dr. King. On--I'm just making sure I can give you the 
accurate information. On September 8--we actually knew it on 
September 7--the Wisconsin laboratories were isolating these 
from stool samples. Wisconsin actually put up then, the 
laboratory posting at the PulseNet Website on September 8.
    Senator Burr. So on the PulseNet Website, they put up and 
that was--that coincided with when CDC understood there was an 
outbreak?
    Dr. King. We knew then that Wisconsin had matching 
isolates.
    Senator Burr. OK. And it was September 8, September 9, 
September 10, September 11 before it was confirmed that this 
was, in fact, the case?
    Dr. King. Well, I think--you know, the key to us was that 
we confirmed that on September 11 and we also identified that 
same match. So we confirmed what Wisconsin knew.
    Senator Burr. Walk me through what took place from the 8th 
to the confirmation on the 11th?
    Dr. King. Let me get the right answer.
    Senator Burr. Sure, sure.
    Dr. King. We had a call from Wisconsin that night, on 
Friday and that data then was sent to us--and I'm not sure if 
it was sent Friday night or over the weekend but we did confirm 
it on the 11th.
    Senator Burr. Mr. Chairman, I'm not sure what is going on 
with our mic system but I'll try to go ahead. Help me 
understand something. CDC is notified of an E. coli outbreak. 
How long does it take for you to confirm that, from the time 
that you hear it to the time that you confirm it? Is it 4 days? 
Is it 2 days? Is it 1 day?
    Dr. King. Well, it depends when the State actually uploads 
and sends that to us for computer analysis.
    Senator Burr. OK. Did the State upload it on the 8th? Did 
you receive it on the 8th and then confirm it on the 11th? Is 
that correct?
    Dr. King. That's correct.
    Senator Burr. Does it take the 9th, the 10th and the 11th 
to do this confirmation or was there a period of time where 
there was not the degree of attention to confirming this?
    Dr. King. Let me kind of explain.
    Senator Burr. Sure.
    Dr. King. You know, the thing for us that really made this 
an outbreak was September 13. The real--and that happened 
because another State actually had an outbreak. In this case, 
it was Oregon.
    Senator Burr. Well, the 13th also. Wisconsin now has done 
their interviews. They've now determined that they think 
spinach is the culprit, correct?
    Dr. King. They have a high probability that they think that 
may be the case, yes.
    Senator Burr. You state in your testimony that it was a 
small cluster. So there were not many people to interview. I'm 
trying to understand when Wisconsin says we've got an E. coli 
outbreak and yes we have all of these guidelines for growers 
and processors and we have guidelines at CDC and FDA as to when 
this happens, here's what we do. Were those guidelines followed 
internally? Did we process the information that we were 
supplied as quickly as we could or did we not take this as 
seriously as it ended up being?
    Dr. King. I think we took it seriously. Also to let you 
know about what's happening in the background as this goes on, 
every day we get confirmed cases of E. coli. Every day we get 
confirmed cases of salmonella. As a matter of fact, you know, 
there's some estimates right now that there may be as many as 
73,000 E. coli cases every year. So the idea of having eight 
cases in a single State is something certainly of interest and 
because it was matched, there was interest. We also are 
continuing to look at ``background noise.'' Cases that come in, 
other E. coli cases that are positive that we also need to 
check. It's when that came to us, second State, with far 
geographic differences that that really rang the bell for us 
that this was an outbreak that probably wasn't a source from 
one single State.
    Senator Burr. Does every State have PulseNet?
    Dr. King. Yes, sir. Every State does and some States 
actually have more, like California and some cities actually 
have their own PulseNet system, like New York.
    Senator Burr. When PulseNet found a match between the 
samples of DNA fingerprints from Wisconsin and Oregon, who was 
notified?
    Dr. King. There is actually a PulseNet Board that goes up, 
where those results then are available to all members of that 
system. So frankly, every State then, should have understood 
that there was a match and when that happened, we also have a 
system called Outbreak Net, where we actually then put together 
epidemiologists, State public health officials and actually 
talk about this.
    Senator Burr. How are they notified?
    Dr. King. That is either through conference call or through 
the Internet process.
    Senator Burr. So in every State, they either have an 
Internet communication from the CDC or they got a phone call.
    Dr. King. That's correct.
    Senator Burr. OK. Does PulseNet recognize a match or does a 
human recognize a match?
    Dr. King. Say that again, Senator.
    Senator Burr. Does PulseNet recognize a match or does a 
human recognize a match?
    Dr. King. Actually, it's first recognized by a pretty 
complex computer system. We go back then and check it by 
individuals just to make sure. But the initial matching is 
actually done through the computer system itself.
    Senator Burr. In the days after 9/11, I was in the House 
and as we began to work--I think, Mr. Chairman, on the first 
bioterrorism bill, I was amazed at that time to find out that 
every public health entity in America did not have a fax 
machine. Yet at the time, our communications--standard 
communication from government to those entities was by fax. In 
those cases, if somebody didn't recognize the fact that there 
was a public health entity in the network that needed a phone 
call versus a fax, they were never notified.
    Now, you've already told me that every State has PulseNet 
so they should have access.
    Dr. King. These are the public health labs that we have as 
part of the network. There would be other public health labs 
around States that may not--that aren't our PulseNet network.
    Senator Burr. On a State level, who would have access to 
PulseNet? People in local health departments or just people 
within the State administration?
    Dr. King. All the PulseNet users, epidemiologists and 
people in the State diagnostic laboratory.
    Senator Burr. So, in essence, they could get the 
information but it may never get to the local public health 
infrastructure of an affected area, through PulseNet. Am I 
correct?
    Dr. King. I don't believe it really has to. Once the 
information gets out and it's publicized and the public knows, 
then I think that we've done what we need to do. So not every 
laboratory in the United States would need to have PulseNet.
    Senator Burr. Well again, I'm trying to understand the 
process and then put it in reverse and try to understand if a 
local person doesn't have access to PulseNet, then what compels 
a local public health entity to make the right notifications to 
State officials that an outbreak may have started. We've got a 
system that is connected between two points. Unfortunately, 
there seems to be a missing point out there on the receiving 
end, on the transmission end, that has to be initiated by 
either a hand-off to somebody on your part or an initiation at 
a local level by somebody to the State. If, in fact, you have a 
breakdown either place, then you've got potential delays, which 
is a health issue. If other States had submitted samples with 
identical DNA fingerprints, how would the CDC have notified 
those States that the fingerprints matched what they found in 
Wisconsin and in Oregon?
    Dr. King. Senator, that did happen.
    Senator Burr. Is that done automatically by PulseNet?
    Dr. King. It's done either through a phone call or an email 
or both.
    Senator Burr. But it requires a human intervention to 
initiate that, is that correct?
    Dr. King. That's correct.
    Senator Burr. In your written testimony, you stated that in 
this outbreak, the average time from illness to onset to DNA 
pattern submission to the national database at CDC was 15 days.
    Dr. King. Correct.
    Senator Burr. Two weeks seems like a long time to me. Is 
that standard or is this the exception to what you would hope 
that timeframe to be?
    Dr. King. We actually saw this as how the system worked 
pretty well. I thought this was a success in terms of the speed 
that that got done. Could we shave off a few more days? We 
always are looking to do that. But 15 days to identify a 157, 
do the matches, understand it's in multiple States, get the 
information out, FDA's rapid response, to understand that 
spinach was involved. You generally have to go through, often a 
complicated case control study to understand.
    Senator Burr. Well, isn't that the Wisconsin interviews, 
though?
    Dr. King. It was the interviews but it was suspicious that 
it was spinach. Oregon--it was also possible that there was 
other foods that were possible. So they weren't 100 percent 
sure. When we got the call from Oregon, Oregon said, we think 
this may have very well involved spinach. So that's when it 
really started to come together.
    Senator Burr. According to the Association of State and 
Territory Health Officers, 42 percent of the current 
epidemiology workforce lacks formal academic training in 
epidemiology. That's a little worrisome to me. If you believe 
that's an accurate percentage, tell me how we fix that.
    Dr. King. I've heard that statistic as well. It's not good 
news. My understanding is that of the jobs that are defined as 
epidemiology jobs, I think 42 percent of the people don't have 
formal training in epidemiology. So is there a cross over--I 
don't know. I think that's unacceptable, Senator, and I think 
it means that we have a lot more work to do, to do further 
training and build up, if you will, the capacity of an 
infectious disease workforce. I think it is really important 
and I would agree with your assessment.
    Senator Burr. Thank you, Dr. King. I haven't meant to pick 
on you but I wanted to make sure in this first round of 
questions, that I was able to understand these timeframes a 
little bit better. If I understand the Chairman's intent, it is 
to bring up the second witness and then bring these two doctors 
back up to the table. Am I correct?
    The Chairman. Yes, I hope they would stay. I need them to 
stay for the next testimony because that may bring up some more 
questions.
    Senator Burr. I have some additional questions but I'll 
save them for that period, if it's okay with the Chairman.
    The Chairman. OK. I've got a couple that came up as a 
result of your questions that I want to ask. When you're 
talking about shipments from the testing labs to the State or 
to the Federal labs, what gets shipped? Is it samples or is it 
data?
    Dr. King. In this case, it is samples. So it's collected 
from a healthcare worker. It is moved then to usually a 
clinical laboratory, which is generally private. So there is a 
period of time when that happens. It takes several days, 
actually, for that culture to grow. When it is identified as E. 
coli, the sample of the bacteria, is moved into the PulseNet 
State laboratory and that's where the procedure takes place for 
it to be segmented and worked on, enzymes, restriction enzymes 
and actually go then to the Pulse shell part of that.
    The Chairman. Now you've mentioned the eight people in 
Wisconsin. Does this process speed up if it's a larger sample 
of people? Or does it still take the same amount of time?
    Dr. King. It still takes a finite period of time to grow 
the sample, to ship it, etcetera. I think what we do know is 
that once the information got out that there were matches and 
other States understood that an outbreak may be pending or 
starting, then I think people were much more observant. We had 
calls with clinicians that talked about sending samples and 
treating cases, etcetera. So once that got known, I think 
people were more aware and more alert. But it does take a 
finite period of time to go through those steps.
    The Chairman. So you're saying that if there is an 
intentional contamination, we're still looking at 15 days?
    Dr. King. That's what it was in this case and you have to 
remember that also included the probable confirmation that 
spinach was the vehicle. It usually takes a little while longer 
to really go through what we call case control studies, talking 
to people that became ill, going back and seeing what they ate 
at certain times and comparing those with people that weren't 
ill and do that kind of a comparison to get a statistical 
analysis of what the vehicle was.
    The Chairman: This is a question for both of you. Once you 
find something, how else, besides PulseNet, do the FDA and/or 
the CDC reach out? Do you use other ways, such as the Health 
Alert Network? What other mechanisms are there? A question for 
both of you.
    Dr. Brackett. Well, we'll use any kind of mechanism that we 
can, one of which is, of course, through press releases, if 
it's a general piece of knowledge. We will use the networks 
that are established with the public health system, in some 
cases, with the agriculture departments, if they have 
responsibilities for foods, to alert them that there might be 
something going on as well. So it's a variety of different 
ways. There is a network of individuals who know each other 
within the States and within the Federal Government that will 
contact each other.
    The Chairman. Thank you. Dr. King, did you have some 
additional comments on that?
    Dr. King. Yes, sir. We also use, as I mentioned, a method 
called Outbreak Net, where we actually then incorporate 
epidemiologists and key State health officials in all the 
States, to talk about the outbreak, to get different ideas, to 
make sure that they are aware. We use conference calls a lot. 
During that outbreak, we had conference calls almost daily with 
States and diagnostic laboratories. Then they really have a 
network of networks in terms of what they do within their own 
States.
    The Chairman. Thank you. Yes?
    Senator Burr. Could I ask two additional questions?
    The Chairman. Sure.
    Senator Burr. Is spinach safe to eat today?
    Dr. Brackett. The comment that we've made is that it is as 
safe as it was before the outbreak, which is to say, the 
relative risk is low considering the total amount of tonnages, 
the number of servings that are eaten for a year. However, does 
that mean that improvements can't be made? No. I think that we 
can make improvements to the safety of all of our ready-to-eat 
produce so that's our goal. But I would say that what we--we 
will more likely let consumers know when we know something is 
not safe and until that time, they are to assume that there is 
no reason not to eat it.
    Senator Burr. Is the contamination, the E. coli 
contamination that took place with the spinach, was it a 
surface contamination or was it absorbed through the root 
system of the spinach?
    Dr. Brackett. Well, both are possibilities. We really don't 
know, is the answer. Yet hopefully at some point, we'll find 
out. But it's more than likely that it was surface 
contamination, just by the environmental possibility and the 
number of people that became ill. But there is at least some 
scientific evidence to say that organisms like that can be 
uptaken through the roots in plants or through the flowers. But 
we have no evidence that that was the case in this particular 
instance.
    Senator Burr. I thank you, Mr. Chairman.
    The Chairman. Thank you very much and I thank you, Dr. 
Brackett and Dr. King and would ask that you have a seat until 
we finish the next testimony and we'll see if there are 
additional questions that come out of that. While you're doing 
that though, I would mention that this is only a week after the 
report that those people who eat 2.9 servings of vegetables a 
day live 5 years longer than those who only eat one serving a 
day. So the green vegetables are particularly important.
    We'll now hear from Dr. Kevin Reilly, who is the Deputy 
Director of Prevention Services of the California Department of 
Health Services. Dr. Reilly will discuss the role of this 
department in identifying and containing the E. coli outbreak. 
We thank you for being here, Dr. Reilly, and for your 
testimony.

  STATEMENT OF DR. KEVIN REILLY, DEPUTY DIRECTOR, PREVENTION 
SERVICES, CALIFORNIA DEPARTMENT OF HEALTH SERVICES, SACRAMENTO, 
                               CA

    Dr. Reilly. Good afternoon, Chairman Enzi and Senator Burr. 
I am Dr. Kevin Reilly. I work with the California Department of 
Health Services. Our programs played an important partnership 
in the investigation of this E. coli O157:H7 outbreak, the 
multi-state outbreak resulting in more than 200 illnesses, 3 
fatalities in 26 States and serious economic impacts, both on 
the public sector as well as within the industry, in California 
where this spinach came from.
    Thank you for having me here today to discuss our role in 
the investigation and our recommendations to help prevent such 
an outbreak due to contaminated fresh produce from happening 
again in the future.
    As was mentioned earlier, California first learned of the 
outbreak during a nationwide teleconference on the 14th of 
September. By the end of that teleconference, Federal officials 
and the affected States had reported 51 cases of a O157:H7 and 
one possible fatality in 13 States.
    They were related based on the bacterial genetic testing 
that Dr. King mentioned fairly extensively. By the end of that 
week, there were over 100 cases reported in 21 States. What 
happened in the very beginning was that a significant suspected 
risk factor came up in that very first teleconference--
consumption of fresh, pre-packaged spinach by the individuals 
who had become ill.
    I won't mention or repeat Dr. King's testimony. I did talk 
a little bit about genetic testing but this played a key role 
in this outbreak. In the past, public health officials have not 
really had good ways of looking at--trying to link seemingly 
unrelated cases that may represent a widespread outbreak with 
very low rates of infection. That changed in 1993 with a very 
large outbreak of E. coli O157:H7 in the western United States, 
associated with Ground B, if you may remember this outbreak. 
CDC did an excellent job of developing the PulseNet system at 
that point by developing enzymes and methodologies, standard 
methods for Pulse-filled gel electrophoresis, genetic is done 
and really has created an excellent tool for us to use in these 
outbreaks.
    As Dr. Brackett noted, on September 14, the FDA District 
Office and the Department of Health Services in California 
conducted a conference with three major fresh produce 
facilities, processors, in the Salinas Valley. These are 
entities whose products had been named by patients as part of 
this outbreak investigation. We advised those firms in that 
teleconference of the outbreaks and made very strong 
recommendations that they initiate voluntary recalls of the 
product at that point, based on the information available.
    On that first day, I believe 22 of 39 patients who had been 
interviewed, recalled consuming fresh pre-packaged spinach in 
the several days prior to the onset of illness. That's at a 
rate much higher than the regular consumption rate of spinach 
by the general population based on data published by USDA on a 
regular basis.
    The majority of these patients had consumed products that 
were manufactured, processed or co-processed by a particular 
company in San Juan Batista, California called Natural 
Selections Foods. We informed them of the circumstances. We 
told them that FDA and DHS would be onsite in their facility 
later that day and we started the investigation at that point.
    Natural Selections confirmed that they co-package for 
several large manufacturers, national brands--Dole, Trader 
Joe's and several private companies that had been named by the 
patients. Later that day--actually the next day, Natural 
Selections did a voluntary recall of their product.
    FDA and DHS initially activated our CalFERT Team. That's 
our California Food Emergency Response Team. This is a 
specially trained group of microbiologists, food investigators, 
epidemiologists and other persons with real expertise in farm 
investigation and produce trace-backs. In the past, DHS and FDA 
have done their own thing. They've done independent 
investigations, sometimes with better coordination than others, 
but clearly that results in duplication, inconsistency and 
basically confusion, not only for ourselves but for the 
industries that we were investigating.
    DHS and FDA, about a year ago, sought to fix that. That's 
when we put together this team of Federal and State employees 
to be able to do these investigations onsite and minimize those 
sorts of problems. We communicated very well, trained well 
together and investigated well together.
    Over the following week, information about the 
epidemiologic investigation that was ongoing around the 
country, including the isolation of spinach--of the E. coli 
O157:H7 strain type, the outbreak strain, from spinach packages 
consumed by some of the patients that had been affected and as 
well as work with the Natural Selections processing plant 
resulted in nine farms being identified. This is within a 
week's time of our first knowledge of the outbreak. That's 
unprecedented. We've never been anywhere near that fast in 
doing a trace-back to determine location and source of an 
outbreak, a vehicle, food vehicle in an outbreak.
    The CalFERT team members were onsite immediately. As the 
investigation matured, we started to find that the product in 
question was produced on a single day, August 15. It was a 
single processing plant. It was a single shift on that 
processing plant. Based on a very thorough record review, we 
were able to narrow the number of farms implicated down to four 
and this was in two California counties in the Salinas Valley, 
San Benito and Monterrey County.
    We went on those farms immediately, within 2 weeks of the 
initial outbreak. We discovered that there was no produce on 
two of the fields that were implicated. The other two had some 
fresh spinach and other product onsite. Voluntarily, the 
farmers immediately tilled that under to prevent that from 
getting into the market. Those fields have not been used in the 
interim to produce fresh produce. Those potential risk factors 
have been removed from potential sources for contaminated 
spinach.
    Trace-back investigations are a lot like detective work. 
We're trying to solve a mystery, trying to figure out the who, 
where, why, what and when of contamination of fresh produce 
that may have caused illness. The environmental investigation 
seeks to identify a long-neck chain--the introduction, survival 
and opportunity for growth of contamination in the involved 
foods. In this case, through growing, through harvesting, 
packaging and ultimately processing of the spinach.
    Unfortunately, these sorts of investigations rarely find a 
definitive cause, a so-called smoking gun, for the outbreak. 
The environmental investigations are very time consuming. Many 
times it will take several months to complete these. It 
involves dozens and dozens of site visits to a number of 
different locations and collection of a large number of 
specimens. We sometimes use an analogy of trying to--imagine 
trying to do an investigation of a multi-car auto accident but 
you don't get to start that investigation until a month after 
the accident occurs. That's very much the way it works with our 
investigations in that by the time patients have been 
diagnosed, reported to local public health, to State public 
health and the investigation, epidemiological laboratory 
investigations are concluded, that could be several weeks, at 
best. So we have a real hard task before us in trying to go 
back to the location and find out what happened on that day.
    Our environmental investigations are very standardized. We 
have staff with specific assignments. We do very in-depth farm 
management and employee interviews. We systematically review 
the environment and practices on those fields. We carefully 
document all these findings and conduct extensive environmental 
sampling for bacteriological testing.
    On all four of these implicated farms, the teams reviewed 
the farms' surroundings, the irrigation sources, wildlife, 
domestic animals onsite, farm worker hygiene, and collected a 
lot of samples. Domestic livestock were involved in three of 
these locations, onsite. You heard testimony about CDC's 
hydrology expert providing excellent support and looking at 
irrigation water, well water, water use on the properties. USDA 
wildlife services helped us with the wildlife issues that we'll 
get to in just a moment.
    The O157:H7 was identified in fecal or water samples at or 
near all four of these locations. All four of these fields had 
E. coli O157:H7 associated with them. Only one of them, 
however, had the matched strain, the strain type based on the 
genetic testing. To date, 10 different isolates from the 
environment have shown up with that same genetic testing. They 
come from cattle feces, wild boar feces, water specimens and 
wild boar that were killed onsite.
    Even before we found these isolates, this particular field 
had a lot of concerns for us. It's in a bowl, in a valley. It's 
right up against a streambed. It's surrounded by hills that 
have lots of livestock operation and there are lots of wildlife 
in this area. The investigators saw very extensive wild pig 
populations and lots of damage to--the attempts of trying to 
secure those fields. Fences were knocked down. They were 
burrowed under. There were tracks through the fields. There 
were rooting areas--pigs like to root and they had done a very 
good job on these fields, of rooting onsite. Again, we saw 
these a good month's time after the harvest dates but it looked 
very consistent in what could have happened on the day of the 
contamination onsite.
    We saw that there was a real large number of pigs there. 
Some areas looked like they were pig highways, just that they 
were running back and forth very regularly and basically 
spending a lot of time onsite.
    When I'm on the highway, sometimes I will get the munchies 
and stop for a snack. That's what these pigs were doing. They 
would knock down fences, get under the fences, come off their 
highways and eat the spinach onsite. I think we have good 
evidence that these pigs had very regular access to these 
fields.
    One last thing--E. coli O157:H7 seems to be very common in 
the Salinas Valley environment. In the past 2 years, we have 
worked with USDA to do environmental sampling of the watershed 
there. We have found periodic contamination on a very regular 
basis in waterways throughout the Salinas Valley. This looks 
like a systematic contamination of this environment. We don't 
know why and we don't know the ecology of all that but it 
appears that this may play a significant role linking back to 
the number of outbreaks of O157:H7 that have traced back to the 
Salinas Valley.
    We've heard about some significant issues with this 
outbreak. It was unusual in that it was very widespread. It was 
unusually virulent. Half the persons were hospitalized that 
were infected and identified. It had a very high rate of kidney 
failure--HUS in patients that were either very young or very 
old that were infected.
    The other aspect of it that was unusual is this outbreak 
was investigated very rapidly and within 2 weeks, we were on 
the farm that was implicated, that was the source likely of 
this outbreak. That's unprecedented. We have never experienced 
anything like that in past investigations.
    Past investigations--FDA has documented 20 E. coli O157:H7 
outbreaks in the past 11 years that are linked back to fresh 
spinach, lettuce or other leafy greens. That's 20 in 11 years. 
Not all those have had trace-backs but half of them, 
approximately, that were traced back or half of the total, 
nine, traced back to the Salinas Valley. Something unusual is 
going on in the Salinas Valley that has resulted in a number of 
these outbreaks. Twenty over eleven years is way too many. So 
you may ask yourself, what have we done about that?
    Starting back in 1996, we started working with the industry 
to come up with good agricultural practices. Some of that 
document was used in 1998, a manuscript that the FDA put 
together, which was a recommendation, ``A Guide to Minimizing 
Microbial Food Safety Hazards For Fruits and Vegetables.'' That 
was the first time that the idea of good agricultural practices 
was actively entertained as a good means to try to prevent 
these sorts of contaminations from happening. That document 
also talked about good manufacturing practices, things that 
we're quite used to in the food processing industry.
    Following the outbreak in 2002, we started meeting with 
this industry. We met with the lettuce and fresh green produce 
industry for about 3 years. We pushed on a research plan. We 
pushed on the idea of trying to get some funding in to 
understand what was happening in this environment. But that 
wasn't enough. We still have outbreaks in that timeframe, all 
the way to the recent.
    CDHS has worked with industry and USFDA to put together a 
safe processing fresh-cut produce videotape to help train 
processors and persons on the farm. We've worked with the 
Western Institute of Food Safety to try to--at UC Davis, to try 
to look at a research agenda, to try to answer some of these 
questions and our State health officer has sent a letter to the 
institute really coaxing and prompting and recommending that 
the industry step up and take ownership of this problem, to try 
to help us determine a cause and a solution.
    Still not good enough. Some of our best efforts have been 
to work with the industry. In April 2006, the industry put 
forward a guideline to lettuce and green leafy commodities, a 
specific guideline to lettuce and green leafy food safety. This 
is a good document. It's something that is looking at trying to 
implement good agricultural practices. The problem is, it's not 
specific. It doesn't have metrics. It's not measurable and a 
farmer in a field doesn't know what to do to specifically 
address some of the food safety risks that are on those fields.
    In mid-2006, FDA and DHS started visiting farms in Salinas 
Valley to try to determine, were these GAPs being applied? And 
were they being effective? The unfortunate thing is, we had to 
stop that short because of the outbreak and we had to spend our 
time investigating it. But of the sites we visited, we found 
that a number of them had not begun implementing GAPs and 
unfortunately, a number of them also were not even aware of 
what GAPs were. That was concerning to us.
    I have a bumper sticker in my office that read, ``E. coli 
happens.'' But I know it just doesn't happen. More importantly, 
we know how to prevent it. When we are investigating an 
outbreak that is traced back to the farm, we know where E. coli 
O157 comes from. It's a normal bacteria in livestock and other 
ruminants. It's a normal bacteria that can be found in wildlife 
and we know the ways by which it gets onto the fields: through 
water, fertilizer, manure, farm worker hygiene problems, 
wildlife, and domestic animals.
    Our job is to try to determine which one of those failed or 
which one of them was responsible for contamination. In this 
particular outbreak, three of those risk factors came up 
positive in our culturing, in our microbiology. That's much 
better than we've done in the past. What it told us is that 
what we're recommending in good agricultural practices are the 
way it will work--are going to be effective means of preventing 
contamination. Three of the areas we have major recommendations 
from GAPs in the areas we found positive cultures.
    We may never be able to actually find exactly what happened 
on the day that the product was harvested, whether it was the 
pigs, whether it was the livestock, whether it was an 
individual traipsing through those fields carrying the bacteria 
onto the fields, but what we do know is we have tools to help 
prevent it. That's what we're moving right now, to implement 
good agricultural practices with this industry in California to 
reduce that risk.
    JPs are of critical importance because as we've witnessed, 
the ability to prevent contamination in the processing plant 
doesn't work. We've had a number of outbreaks where the good 
practices, manufacturing practices in the processing plant have 
simply not worked, notwithstanding the very high levels of 
chlorine and really, state-of-the-art practices that have been 
going on there.
    I think our greatest needs are research to try to figure 
out some of those ecological, microbiological issues and 
consistent application of these good agricultural practices 
every day on every farm so that the opportunity for 
contamination in the fresh produce you and I really want to 
eat, doesn't happen.
    The last issue--we in public health need to balance the 
absolute need for good nutrition, cancer prevention, 
cardiovascular disease prevention, and health promotion, that 
fresh fruits and vegetables provide us. We need to balance that 
with a risk, though be it a very low risk, of foodborne illness 
that may unfortunately cause severe illness and even kill you 
if you are very young or very old or predisposed with immune 
compromise. That's a difficult situation to be in. But what we 
are committed to doing is working with the fresh produce 
industry in California to identify what happens in these 
outbreaks, to implement stages and steps to prevent that from 
happening and to provide good consumer confidence that fresh 
produce consumption not only is good for you but won't put you 
at risk for foodborne illness.
    Thank you for your time. I'm available for questions.
    [The prepared statement of Dr. Reilly follows:]

          Prepared Statement of Kevin Reilly, D.V.M., M.P.V.M.

    Good afternoon Chairman Enzi, Senator Kennedy, and committee 
members. I am Dr. Kevin Reilly. I am the Deputy Director of Prevention 
Services for the California Department of Health Services, which in 
partnership with the FDA, investigated the processing plant and farm 
sources of spinach implicated in the recent multi-state Escherichia 
coli (E. coli) O157:H7 outbreak that resulted in 204 persons reported 
ill and 3 deaths. Thank you for asking me here today to discuss that 
investigation and our recommendations to help prevent such an outbreak 
due to contaminated ready-to-eat produce from happening again.
    California first learned of the outbreak during a national 
teleconference on September 14, 2006 where CDC, FDA and a number of 
States participated. At the beginning of the teleconference, the 
Federal agencies reported 39 E. coli O157:H7 cases and one possible 
fatality in 12 States that matched on bacterial genetic testing. By the 
end of the call, the number had risen to 51 cases in 13 States with 
many more suspected cases being tested. By the end of that weekend, 
well over 100 patients infected with the outbreak strain had been 
reported from 21 States.
    Prior to 1993, public health agencies did not have an objective way 
to link seemingly unrelated cases of illness in different States. In 
1993, a large outbreak of foodborne illness caused by E. coli O157:H7 
occurred in the western United States. In this outbreak, scientists at 
CDC performed DNA ``fingerprinting'' of the bacterium using a method 
called pulsed-field gel electrophoresis (PFGE) and determined that the 
strain of E. coli O157:H7 found in patients had the same PFGE pattern 
as the strain found in hamburger patties served at a large chain of 
regional fast food restaurants. Prompt recognition of this outbreak and 
its cause may have prevented an estimated 800 illnesses. As a result, 
CDC developed standardized PFGE methods and in collaboration with the 
Association of Public Health Laboratories, created PulseNet so that 
scientists at public health laboratories throughout the country could 
rapidly compare the PFGE patterns of bacteria isolated from ill persons 
and determine whether they are similar. PulseNet has significantly 
enhanced the ability of public health agencies and laboratories to 
communicate and more quickly identify ``clusters'' or foodborne 
outbreaks. As Dr. King with CDC described, PulseNet played a key role 
in the early detection of this latest spinach associated outbreak of E. 
coli O157:H7.
    In California and many other States, local public health and 
environmental health agencies have the primary responsibility for 
investigating foodborne illnesses and outbreaks within their 
jurisdiction. In outbreaks involving multiple jurisdictions, the State 
health department takes a leadership role in coordinating the 
investigation. In other States, the responsibility for all outbreak 
investigation is at the State health department level. The California 
Department of Health Services' (CDHS) authority to investigate 
foodborne illness extends to all levels of food production and 
distribution--including to the farm level. Under that authority, CDHS 
partnered with FDA in leading the traceback and environmental 
investigation to determine the ultimate source of contamination that 
caused this outbreak.
    Following the national teleconference on September 14, the FDA San 
Francisco district office and the CDHS Food and Drug Branch hosted a 
conference call with three major fresh pre-packaged spinach producers 
in the Salinas Valley whose products were identified by patients in the 
outbreak investigation. CDHS and FDA advised the firms of the outbreak 
and strongly suggested that the firms consider initiating a voluntary 
recall of spinach products. As discussed during the national 
teleconference, 22 of 39 patients reviewed during the call reported 
consuming pre-packaged fresh spinach in the days prior to onset of 
illness. The majority of patients that reported specific brands of 
fresh pre-packaged spinach identified a brand manufactured by Natural 
Selections Foods LLC in San Juan Batista, California. Natural 
Selections Foods LLC was informed that an onsite investigation of their 
processing facility would be initiated that day, and that CDHS and FDA 
would be requesting distribution information for bagged spinach. 
Natural Selection confirmed that they pack for Dole, Trader Joe's and 
other private labels. Natural Selection e-mailed FDA and CDHS a retail 
distribution data file for product shipped from 8/1/06 to 9/14/06. The 
following day, Natural Selections Foods announced a voluntary recall of 
their pre-packaged spinach products.
    The FDA San Francisco district and CDHS Food and Drug Branch 
activated the California-Food Emergency Response Team (CalFERT), a 
specially trained and exercised group of microbiologists, field 
investigators, epidemiologists, and others with special expertise in 
farm investigations and produce tracebacks. In the past, FDA and CDHS 
investigators would conduct parallel but separate investigations, often 
resulting in duplication of effort, lack of standardized investigative 
processes and procedures, and confusion for regulated firms. CalFERT 
members receive advanced training in environmental investigations, 
develop standardized procedures, jointly conduct the investigations, 
and share all records and reports. FDA and CDHS established the CalFERT 
more than a year ago following investigations of other produce-
associated disease outbreaks traced back to California products.
    Over the week following September 14, information from the 
epidemiologic investigations going on around the country (including the 
outbreak strain being isolated from pre-packaged spinach first in New 
Mexico and ultimately in 13 different situations) narrowed the 
production dates in question. Work in the Natural Selections Foods 
facility rapidly resulted in the identification of nine farms or 
ranches in three counties that supplied spinach to the processing plant 
on the production dates implicated in the investigations. CalFERT team 
members began onsite field investigations within a week of the first 
notifications on September 14, 2006. As the investigation continued, 
the implicated date of pre-packaged spinach production was narrowed to 
August 15, 2006 during a single shift. Based on this information and a 
thorough review of records at the processing plant, the number of 
farms/ranches that supplied spinach for that day's production was 
narrowed to four locations in San Benito and Monterey Counties. From 
this point, the environmental investigation concentrated on spinach 
fields at these four locations. Two of the implicated fields had no 
produce growing on the date of the first visit. Produce on the other 
two fields was voluntarily disked under by the farmers. Produce has not 
been grown on those fields since.
    Traceback and environmental investigations are a lot like detective 
work. The field investigators are trying hard to solve the mystery; to 
find out the who, what, when, where, and how of what happened to cause 
the outbreak. The environmental investigation seeks to identify all 
possible opportunities for introduction, survival, and growth of 
pathogens for the associated food vehicle. This includes detailed 
examination of growing, harvesting, shipping, processing, and final 
preparation/serving practices as well as testing of food handlers/food 
workers when appropriate. Unfortunately, these investigations rarely 
find a definitive source. The environmental investigations are 
extremely time-consuming (may take several investigators several months 
to complete) and may include investigations of dozens of sites/
facilities (farms, distributors, wholesalers, brokers, manufacturers, 
retailers) and hundreds of environmental samples. The analogy we 
sometimes use is to ``imagine trying to investigate a multi-vehicle 
auto accident 1 month after it occurred.'' Frequently, by the time the 
patients have been diagnosed and reported through the public health 
system, and the epidemiologic and laboratory investigations have 
implicated a particular food item, several weeks have passed. In fresh 
produce associated outbreaks, the fields have been replanted in a 
different crop, the harvest crews are long gone, and there are no more 
products to test from retail or consumer's homes.
    The environmental investigation is conducted in a very standardized 
manner. The CalFERT team members have specific assignments, interview 
the farm management and workers utilizing farm investigation 
questionnaires, and systematically review the field environment and 
practices on the fields. They carefully documented all findings and 
conducted extensive environmental sampling for bacteriologic testing. 
The CalFERT team examined each field's surroundings, irrigation 
sources, wild and domestic animal presence, fieldworker hygiene, and 
collected samples. Domestic livestock operations were observed in the 
vicinity of three of the fields and fecal samples were obtained from 
these operations. A hydrology expert with CDC reviewed irrigation and 
obtained well and water management data for the properties. USDA 
Wildlife Services staff assisted the CalFERT team in investigating 
wildlife presence and conducted sampling.
    E. coli O157:H7 was identified in fecal and/or water samples taken 
on or near all four fields. However, only one field has yielded the 
genetic testing matches to the outbreak strain of the bacteria. To 
date, 10 PFGE matches have been identified in cattle and wild boar 
feces, stream water, and intestinal content of a wild boar killed in 
the vicinity of this field. This particular field had features that 
concerned investigators even before sampling. The field is surrounded 
by hills and cattle pasture. Investigators saw extensive evidence of 
wild pig presence in and around the growing fields on the ranch (damage 
to fencing, burrowing under fencing, tracks, feces and evidence of 
rooting in produce fields) and established that numerous pigs thrive in 
the riparian habitat there. Potential avenues of contamination for the 
spinach crop may have included direct pig presence in the field or 
contaminated irrigation water, among numerous other possibilities. 
Investigators continue to investigate the source of the outbreak strain 
in the area. Since June 2004, USDA Agricultural Research Service 
working with CDHS has documented extensive periodic E. coli O157:H7 
contamination in waterways in the greater Salinas Valley, though none 
of the isolates collected from these studies matched the spinach-
associated outbreak strain. The Salinas Valley appears to have systemic 
E. coli O157:H7 contamination in the environment that has led to a 
number of fresh produce associated outbreaks over time.
    In total, more than 800 environmental samples have been collected 
by CalFERT in this investigation including soil, sediment, water, fecal 
material, feral pig tissue, drag swabs, plant material, and 
environmental swabs of harvesting equipment.
    This outbreak was unusual in the widespread distribution of cases 
and in the virulence of the pathogen (more than 50 percent 
hospitalizations, three fatalities, and high rates of Hemolytic Uremic 
Syndrome in young and elderly patients). The investigation of this 
outbreak was unusual in the speed with which the traceback and 
environmental investigation was conducted to find a likely source of 
the contamination. The investigation illustrates the excellent working 
relationships between State and Federal public health agencies, and an 
effective use of the scientific tools now available in the study of 
these pathogens. What still remains to be done is to effectively 
implement what has been learned to prevent the next E. coli O157:H7 
outbreak associated with fresh ready-to-eat produce.
    FDA has documented 18 outbreaks of foodborne illness since 1995 
caused by E. coli O157:H7 for which fresh or fresh-cut lettuce was 
implicated as the outbreak vehicle. In two additional outbreaks 
including the latest multi-state investigation, fresh-cut spinach was 
implicated. These 20 outbreaks account for approximately 610 reported 
cases of illness and five deaths. Although tracebacks to growers were 
not completed in all 20 outbreak investigations, completed traceback 
investigations of nine of the outbreaks associated with lettuce and 
spinach were traced back to California's Salinas Valley.
    In 1998, CDHS provided technical assistance to FDA in the 
development of early guidance to industry entitled ``Guide to Minimize 
Microbial Food Safety Hazards 
for Fruits and Vegetables .'' This Guide recommends good agricultural practices 
(GAPs) and good manufacturing practices (GMPs) that growers, packers, 
and shippers may undertake to address 
common-risk factors in their operations, and thereby minimize food 
safety hazards potentially associated with fresh produce. In 1996, CDHS 
working with the lettuce industry developed voluntary agricultural 
production guidelines for lettuce. This document was used extensively 
in the development of the 1998 FDA GAPs document.
    Following an outbreak of E. coli O157:H7 illnesses associated with 
California lettuce in 2002, CDHS began a series of meetings over the 
next 3 years with the lettuce industry to encourage the industry to 
``step forward,'' develop a comprehensive research plan to identify the 
likely causes of and possible preventive measures for the outbreaks, 
and commit significant long-term research funding to this plan. 
Unfortunately, these meetings did not result in the desired outcome and 
subsequent E. coli O157:H7 outbreaks have occurred.
    CDHS has met with the leafy green industry on a number of occasions 
over the last 2 to 3 years to voice our concerns and to urge the 
industry to take the next step and develop a comprehensive research 
plan for identifying the cause of E. coli O157:H7 contamination in the 
fields and potential solutions, along with providing funding to jump 
start these efforts. We have worked with the industry, FDA, and 
academia to produce a video entitled ``Safer Processing of Fresh Cut 
Produce.'' We have encouraged and participated in the formation of a 
``lettuce steering committee'' at the Western Institute for Food Safety 
and Security at the University of California, Davis and I are 
developing a prioritized research agenda with this working group. We 
have met with FDA managers to voice our support for their open letters 
to the industry and our State health officer sent a letter to the 
California grower industry in January 2006 stating our support for 
FDA's approach, outlining several other areas that we plan to assess, 
and urging the industry to continue their recent commitment to solving 
this problem.
    On February 5, 2004, FDA issued a letter to the lettuce and tomato 
industries to make them aware of concerns regarding continuing 
outbreaks associated with these two commodities and to encourage these 
industries to review their practices in light of FDA's GAPs/GMPs 
guidance and other available guidance. In view of continuing outbreaks 
associated with fresh and fresh-cut lettuce and other leafy greens, 
particularly from California, FDA issued this second letter to 
reiterate their concerns and to strongly encourage the lettuce industry 
to review their current operations in light of the agency's guidance 
for minimizing microbial food safety hazards in fresh fruits and 
vegetables, as well as other available information regarding the 
reduction or elimination of pathogens on fresh produce.
    In April 2006, the lettuce and green leafy industry promulgated a 
Commodity Specific Food Safety Guidelines for the Lettuce and Leafy 
Greens Supply Chain. This document represents an excellent start 
towards Good Agricultural Practices that, if effectively and uniformly 
implemented at the farm level, could significantly reduce the potential 
for bacterial contamination of fresh lettuce, spinach and other leafy 
greens. The Guidelines are relatively generic and lack specificity for 
consistent application on the farm. The next significant challenge for 
this industry and food safety experts is to put specificity and metrics 
to these practices so that they can be applied in a verifiable manner 
on all farms and ranches growing, harvesting and packing leafy green 
produce for consumption in order to assure improved food safety with 
these products.
    In mid-summer 2006, FDA and CDHS Food and Drug Branch kicked off a 
joint lettuce safety initiative with Salinas Valley lettuce growers and 
processors to assess the use of the Guidelines and good agricultural 
practices on the farm, and good manufacturing practices in the 
processing plants. Although the initiative was in place for only a few 
weeks prior to being suspended with the onset of the multi-state 
spinach-associated E. coli O157:H7 outbreak; preliminary findings on 
the farms showed that many growers were not implementing GAPs, and 
several were not aware of recommended GAPs.
    We know where E. coli O157:H7 comes from. It is a common flora in 
cattle and perhaps in other ruminants, and can also be found in the 
gastrointestinal tracks of other wild and domestic animals. The risk 
factors for contamination of produce include water used for irrigation 
or possible from flooding, manure used for fertilization, field 
proximity to infected livestock, access to the fields by wildlife, and 
farm worker hygiene. Our job during the on-farm investigation is to 
determine where the fecal contamination came from, and how it ended up 
on the spinach or other fresh produce in the field. This latest 
investigation showed E. coli O157:H7 matching the outbreak strain in 
three of these potential sources. Although we may never be able to 
determine exactly what happened on the fields during or immediately 
before the harvest of spinach that went into the August 15 production 
lots at Natural Selections Foods, we can reinforce the idea that good 
agricultural practices implemented consistently every day on every farm 
growing fresh ready-to-eat produce will significantly reduce the risk 
for contamination. GAPs are of critical importance because we have 
witnessed that even the most state-of-the-art food processing can fail 
to remove E. coli contamination resulting in outbreaks. We do not know 
why that is the case, but it is. The best solutions for safer, fresh, 
ready-to-eat produce are research to better understand the ecology of 
these bacterial pathogens in the field and on the plants, the 
consistent application of Hazard Analysis and Critical Control Program 
based on good manufacturing practices in the processing and shipping 
environments, and universal application of GAPs on the farms and 
fields.
    We still do not have a lot of science about the environment in 
which these products are grown, how and where pathogens may survive or 
grow in these environments, the effectiveness of various measures that 
growers can take to minimize the chances of contamination. What we do 
know is that there are still a lot of unanswered scientific questions 
about produce microbiology, how and where these pathogens survive or 
grow in the environment, and how traditional green leafy produce 
processing methods deal with low numbers of pathogens. More funding is 
needed for research in these areas.

    The Chairman. Thank you. I'm kind of stunned by the 
previous testimony and your testimony regarding the length of 
time. Most of us don't have any idea of what has to go on when 
there is a problem. An additional one that you raised was that 
21 to 32 people interviewed remembered days before that they 
ate spinach. I can hardly remember what I ate yesterday. I 
suppose if I was sick, I might have better recall--probably 
not. So there are definitely some difficulties with this whole 
process.
    Now you mentioned that some fields have been disked under. 
How long until they can be used to grow spinach again? Can they 
ever be used again?
    Dr. Reilly. That's part of our investigation, Senator. We 
are attempting to figure out what exactly happened there. Now 
these fields are not significantly different than another 
spinach field a mile up the road or maybe 20 miles up the road. 
A number of these are in valleys, a number of them have those 
risk factors I talked about, whether they have the opportunity 
for flooding, the opportunity for livestock or wildlife 
contamination. Some have better farm hygiene, farm worker 
hygiene than others. So the issue is not so much exactly these 
fields. These are not the same fields that are responsible for 
the other 19 outbreaks that have occurred over time or the 9 
that have occurred in Salinas Valley as a source of the spinach 
or fresh produce. We're trying to work with them. They are 
right now under an embargo order. They are not allowed to 
produce the product. If they do grow fresh product, we will 
embargo that product. We do not have a specific timeline for 
how long that order will last. We're trying to look into that 
to discover everything possible about what happened that may 
have predisposed these particular fields to be implicated.
    The Chairman. Now you mentioned in your testimony that 
there were other fields that tested positive for E. coli but 
they weren't the outbreak strain. Have conditions or the 
possibility of embargo been placed on them, too? Your testimony 
says that E. coli is pretty common. So what is the dividing 
line between the embargo and not?
    Dr. Reilly. That's an excellent question, Senator. We were 
investigating this outbreak. We traced back and found evidence 
of this actual strain type, the outbreak strain, on a single 
farm and we acted aggressively there to prevent that farm from 
bringing any produce to market. The other four farms, the 
investigation is ongoing. We have not, to date, identified the 
strain match, the genetic match. We have found a O157:H7, as 
you mentioned, on those farms as well. Our actions again, an 
attempt to try to protect the public's health. At this point, 
the season for growing spinach is very rapidly coming to a 
close in the Salinas Valley. They are transitioning to the 
southern portion of the State but we will be faced with the 
same question next spring, when those fields are again planted. 
We don't know why the ecology of the Salinas Valley predisposes 
to this contamination and it is not a unique finding. Over 2 
years, we've found systematic contamination of the waterways in 
areas in the Salinas Valley with the O157:H7. There is still a 
lot of science that we don't know about as to why this is 
happening.
    The Chairman. That's very distressing, since that is the 
salad bowl of the Nation. I'm glad you're on top of it. Now you 
indicated in your testimony that California didn't know about 
the outbreak until September 14, when it was announced 
publicly. But Dr. King stated that the outbreak was posted on 
PulseNet on September 8. Why the delay?
    Dr. Reilly. We were not aware of the multi-state nature of 
the outbreak until the CDC and FDA pulled together the multi-
state teleconference. We monitor PulseNet. We, as Dr. King 
mentioned, have several laboratories that feed into PulseNet. 
We had a single case that was matched, strain type matched. We 
discovered, I believe that day, that went up on the PulseNet.
    Part of the usefulness of PulseNet is that it prompts 
further surveillance and targeted surveillance. One of the 
first things we did in California was to send notices to all of 
our public health officials in the State and out to providers 
as well, to start looking for this. If you see it--bloody 
diarrhea illness or illness compatible with O157:H7 to get that 
culture in right away and to try to look for this in order to 
document cases.
    But frankly, we did not have cases that we had identified 
as part of the outbreak on the date that Wisconsin started. 
Over a couple days, that investigation matured and a second 
State came in. That is when FDA and CDC chose to put together 
that national teleconference to reach out and see what else was 
going on. Frankly, in the beginning of that teleconference, I 
think they were talking about 30 or so cases--by the end of the 
conference, it was 59, 60 cases. That's the nature of public 
health, collaborating to find out what information is available 
and then trying to target our efforts.
    The Chairman. Thank you. Senator Burr, do you want me to 
call the other two up to the table at this point or do you want 
to ask some questions here?
    Senator Burr. Mr. Chairman, I'd be happy just to ask a few 
questions first and then get everybody together if Senator 
Isakson wants to do the same. Dr. Reilly, welcome. California 
doesn't have a different set of standards for agricultural 
products, like leafy vegetables, than everybody else in the 
country?
    Dr. Reilly. A different standard?
    Senator Burr. Yes, I mean, you've got a different standard 
for everything else in California. I just find it incredible 
that there is not a higher standard as it relates to this.
    Dr. Reilly. We certainly do have State laws that regulate 
processing. But we do not have specific laws on farm food 
safety.
    Senator Burr. Trust me, I'm not challenging you to come up 
with any new ones. How do you clean up contamination from pig 
sites? Is that even possible?
    Dr. Reilly. I don't know the answer to your question, 
Senator. It doesn't appear that E. coli O157:H7 is--that the 
pig is a definitive host. It's probably just an accidental 
host. It looks like this bacteria probably evolved in 
multichambered stomach ruminant animals--cattle, maybe other 
wild ruminants. How the pigs became infected, we don't know. 
You can use your imagination and figure out.
    Senator Burr. Let me walk through the process and tell me 
if I understand the growth and processing process. The spinach 
is in a field. It's grown. It is irrigated from somewhere. That 
water applied to the spinach might cause a surface 
contamination of E. coli. But in California, like everywhere 
else, there is a washing process at the end of the process that 
has chlorinated water and maybe other things that is applied to 
leafy vegetables--and the specific intent is to kill any 
contamination.
    Dr. Reilly. No, Senator. First of all, the processing of 
green leafy vegetables in the pre-packaged products that you 
see is regulated. There are good manufacturing practices that 
have utilized the concept of hazard analysis critical control 
point, trying to identify what are the potential critical 
control points where you can apply controls to prevent 
contamination. In the processing plant, that philosophy is used 
in the washing process, multiple washing processes and the use 
of high levels of chlorination--hypochlorite--in doing that 
rinsing. It is not designed as a kill step, though. It's not 
like cooking hamburgers to 160 degrees for a given period of 
time to kill the bacteria.
    Senator Burr. So it's possible that you can have E. coli in 
the field as a surface contaminant and there is no process in 
those final stages that would kill that contamination. Correct?
    Dr. Reilly. As of right now, the processing of fresh leafy 
green spinach or lettuce does not involve a kill step like 
that. The kill steps that traditionally would be used tend to 
change the nature of the spinach and it's no longer a fresh 
leafy green anymore, by heat or radiation.
    Senator Burr. If the surface contamination did not take 
place in the field, could the surface contamination have 
happened in the washing process?
    Dr. Reilly. That's certainly possible. In addition, 
contamination following processing is possible, whether it be 
on the supermarket shelves or in your kitchen or in a 
restaurant kitchen, cross contamination is probably responsible 
for most foodborne illnesses. But not in this case.
    Senator Burr. Is it safe to say that if I open a bag of 
pre-packaged spinach and I wash it, I can't wash E. coli off of 
it?
    Dr. Reilly. If there were E. coli contamination on the 
surface, you may not be able to reduce it to a level that would 
not cause you illness. Yes, you can reduce the levels. Whether 
you can make it safe--if it is already contaminated, we don't 
think so.
    Senator Burr. Well, I'll save my last question until we get 
everybody up but you present us a scenario that I'm worried 
about. I was somewhat disturbed when we started because we were 
talking about a contamination that we don't understand yet. Now 
you've thrown a new kink into it--we may never know why the 
spinach was contaminated because there are multiple places that 
it could have happened and--I'm not soliciting an answer from 
you now. I'm pre-warning the other two but I will ask it. Is 
that the scenario that we're at? We don't know how. We know it 
got contaminated and it's likely we will never know exactly how 
it was contaminated. Thank you, Mr. Chairman.
    The Chairman. Senator Isakson.
    Senator Isakson. Really just one question. This reminds me, 
food safety has not been my business but I've been in the soil, 
sand and erosion control business for a long time and that 
being said, despite best management practices there are going 
to be gaps in any agricultural practice. You're going to have 
siltation and it sounds like you're going to have E. coli. The 
best thing is to have the best possible practices in place to 
prevent that from materializing into a problem. Is that 
correct?
    Dr. Reilly. That's correct and we believe those good and 
best management practices can reduce it to a level where it 
will be very unusual or perhaps prevent these outbreaks from 
ever occurring.
    Senator Isakson. And isn't it also--would this be a correct 
statement? It would seem to me likely that the producer of the 
spinach or a leafy vegetable has a high level of motivation to 
incorporate the best practices because they're going to suffer 
significant losses if they get a batch of their product that 
ends up being processed and has E. coli, is that correct?
    Dr. Reilly. I would think so.
    Senator Isakson. OK, last thing, just a question. In your 
statement, you basically say, we're going to have E. coli. It's 
out there. We can try and use all these best practices but what 
we really need to do--there is no cure. We'd need more money 
for research. I think that was kind of what you said. My 
question is, is there current research going on--in milk, we 
have--in orange juice, you have pasteurization. Is there 
something going on with leafy vegetables?
    Dr. Reilly. There is some research going on but in my 
opinion, not adequate. Simply being unable to answer a question 
as to what is the risk for internalization of this bacteria 
into freshly harvested produce or what potential is there for 
drawing bacteria up through the root system and what are some 
of the preventions that we could do there? That would help to 
inform what happens on the farm, during those harvest periods 
and reduce the risk even more. HACCP and good manufacturing 
practices, good agricultural practices are based on science. If 
they are going to work, they have to be based on science. We 
don't have enough science to base those on, to be comprehensive 
at this point.
    Senator Isakson. Thank you, Mr. Chairman.
    The Chairman. Thank you. At this point, if I could have Dr. 
Brackett and Dr. King join us. I just have one important 
question for any legislation that we happen to be doing that 
I'd like all three of your opinions on. That is: are additional 
authorities needed to help you work together more effectively 
during an outbreak? Do we need another agency? What do we need?
    Dr. Brackett.
    Dr. Brackett. Well, as I mentioned during one of the 
questions here, that we have gained so much information from 
this particular outbreak and I've learned so much that we were 
in the process of looking, actually and sort of doing a hot 
wash of what would have worked, what wouldn't have worked in 
terms of would additional authorities have helped? Would they 
have not made any difference? And all of that, I think is going 
to be at the conclusion of the investigation when we try to 
figure this all out.
    The Chairman. Thank you.
    Dr. Reilly.
    Dr. Reilly. I think that my principle observation is that 
this worked far better than investigations I've been involved 
with back over the last 12-plus years. The fact that USFDA and 
the Department of Health Services had some vision to put 
together a response team, where we've worked together versus 
independently, the fact that we had very routine conversations 
with the State health departments and agriculture as well, FDA 
and CDC was really visionary on their part. They did a great 
job of making this communication effective from the first day. 
So in my opinion, I think that we've done better here than ever 
before. Does that mean we can't do better? No. But I don't know 
that a change in organizational structure does that. It's a 
culture change that has been coming and has been maturing over 
time and I think this is evidence of maturation in our working 
relationships between the Federal and State agencies.
    The Chairman. Thank you.
    Dr. King.
    Dr. King. Yes, Senator. I don't have a position on it. I 
would say that the most important part is not going to--how 
many boxes or how many authorities there are but the 
relationship that work. I think our work with, in particular, 
local and State health departments are absolutely critical in 
this. CDC is a nonregulatory agency. We would like to maintain 
that stature in terms of investigation. E. coli and some of 
these microbes could be presented in ways not through food and 
we still have to do those kinds of investigations so that one 
step of independence and objectivity, I think is critical from 
our point of view.
    The Chairman. Thank you. Going back to our CDC expert, 
Senator Isakson, did you want to ask the three of them any 
questions?
    Senator Isakson. I want to welcome Dr. King and I 
appreciate his tremendous contribution to the World's Health 
Center in Atlanta, Georgia at CDC. Thank you, sir.
    The Chairman. We'll wait just a moment here until Senator 
Burr is back in the room. You have mentioned, particularly Dr. 
Brackett, some things that have been learned from this. If any 
of you have some suggestions, if you could get those to us as 
quickly as possible, we'll see what can be incorporated in 
anything that we do, so that we can have your best guess. I've 
always found that the best people to ask are those who are 
intricately involved in it on a daily basis. Sometimes that's a 
bit too common sense for us here but we'll live with it.
    Senator Burr.
    Senator Burr. My apologies, Mr. Chairman. Dr. King, let me 
go back to a statement that you made--you had seen X amount of 
cases of E. coli during this similar period. Were any of those 
cases the same type of cluster that you saw in Wisconsin?
    Dr. King. Let me give you a little bit of the context for 
that, Senator, if I may. We are constantly looking at matches 
in our system. In the last 10 years, PulseNet has 240,000 
submissions. So that is what we have on file as a large 
computer base to look at. Two hundred and forty thousand. At 
the time that this spinach outbreak was getting going, we would 
see outbreaks of E. coli--cases of E. coli every day. One of 
the things I want to make sure I'm clear about, is that a 
cluster doesn't necessarily mean it's an outbreak. A cluster in 
one State is of interest to us. The real critical issue for us 
here was September 13, when we had a separate State with a 
large geographic distance with a match. Then we really got 
concerned. There may be, in summer and fall, 90 E. coli cases 
that we see a day reported to us. So the idea that we see one 
or two or three cases that may be a match is of interest and we 
monitor those. In this particular E. coli, O157:H7, we have 
seen cases of this particular microbe every month since 2003. 
So the idea of seeing a cluster of cases in one State, why of 
interest, does not trigger an outbreak or the kind of 
investigation that occurred on September 13. So this whole 
background of ``it's not just E. coli''--it's salmonella. It's 
campolabactor. It's listeria, that we have to monitor and look 
at. So the system is open constantly. It's open for States to 
send in information.
    Senator Burr. And I hope you understand. All I'm trying to 
understand is, what is that threshold at the CDC that says, 
``Whoops! This one goes right to the top of the list. We've got 
all this clutter over here that we've got to look at.'' That's 
our job. But what triggers part of that clutter to launch up in 
importance--the CDC is an important part of this whole process.
    Dr. King. Yes, sir. We realize that. And for us, the 
difference between a September 8 of a cluster in a single State 
that might have been a single source outbreak in Wisconsin, 
which was being investigated and rightly so. It was of interest 
to us. When another State got involved with a cluster of cases 
and there was a match. We say, ``well how did a match occur in 
Oregon and at the same time in Wisconsin?'' Then we knew that 
there had to be probably other sources and then we were 
concerned. That was the very day. That conference went out, 
that we contacted FDA that evening. FDA then, the very next 
day, came forward and talked to the public about potential 
threats of eating spinach. That's unprecedented in terms of the 
action.
    Senator Burr. Let me go to Dr. Brackett, if I can. That 
correspondence happened and I'm going to play the what-if game. 
What if spinach processors and distributors had not cooperated 
and refused to pull spinach off the shelves and out of 
distribution centers--what could the FDA have done?
    Dr. Brackett. Well, one of the first things is if we had 
any indication that the product was actually contaminated with 
the E. coli, we could have seized the product because it was 
adulterated under the Food, Drug and Cosmetic Act. So that's 
probably the first thing that could have been done. We also 
could have used one of the provisions in the Bioterrorism Act, 
which is withholding the product and getting it off the market 
that way as well.
    Senator Burr. Your initial warning was much broader than 
leafy spinach. Going back through that, could that have been 
narrowed down any faster than it was?
    Dr. Brackett. Well, we would have loved to narrow that down 
much faster. At the time, if you can put yourself in this 
situation, what we were seeing was information from the CDC 
where we had increases in the number of cases being reported, 
you know tens by daily or even hourly, all we knew is that they 
had consumed fresh bagged spinach and that's all we knew. It 
was happening across the country. There was a high virulence 
with it. We didn't know whether this would amount to 500 cases 
or 5 but we thought it was in the best interest of the public 
to warn them and make sure that the consumption stopped.
    Senator Burr. In your opinion, the process that you had in 
place worked? The process at FDA--did it work?
    Dr. Brackett. Yes, it did work. Our process, when we have 
outbreaks like this, is to work closely with CDC. When we get a 
true definition that there is an outbreak with food, we take 
whatever appropriate action, that would be enough in the case. 
If we happen to know a specific brand at that time, we'd have 
just notified the public or asked to recall that specific 
brand. But this was just so large, so fast and such a lack of 
information for the first few days that that's why we took that 
unprecedented action.
    Senator Burr. Does the FDA need any additional power in 
this area to require growers, processors, and distributors to 
follow safer practices?
    Dr. Brackett. Well, as Dr. Reilly said, the number--the 
general safety practices that we have, I think, are good and 
they are improving as we learn more about the ecology of this 
organism. At this point, as I mentioned to the Chairman, we're 
still trying to look back and learn from this whole outbreak to 
find out if additional authorities at any points would have 
helped or whether they would have not made any difference at 
all. And once the whole investigation is over, we're going to 
put together some thoughts on that.
    Senator Burr. One last comment, if I could and again, I 
want to thank all three of you for your willingness and your 
openness here and especially you, Dr. Reilly, because this was 
in your back yard. But I want to go to the heart of a statement 
that you made. You said that if all the growers followed good 
agricultural practices and I think you added good manufacturing 
practices, this might not have happened. I've gone to great 
lengths to try to figure out where this happened--a field, 
processing, water, soil, roots, surface and clearly, there's 
not enough known that anybody is willing to say, ``here, this 
and that.''
    I'm not convinced today that if you just applied good 
agricultural practices and good manufacturing practices we 
would get no contamination, based upon what I've heard. And you 
can comment if you want to. I only point that out just to say 
that simply making sure that everybody applies to ``X,'' not 
knowing how it happened, I'm not sure we get to an end result 
of no E. coli or no contamination.
    Dr. Reilly. Senator, I believe that--well, first of all, we 
have good manufacturing practices in processing right now, 
across the country.
    Senator Burr. But not all farmers apply it, not all 
processors apply it, is that an accurate----
    Dr. Reilly. In processing, licensed processors--they 
practice good manufacturing practices. It's a mandate in 
California. I think it's a mandate in many other places, not 
everywhere. What we do not have is a mandatory program with 
good agricultural practices. I'm not recommending a mandatory 
program but I am recommending that we have systematically, from 
a cultural standpoint, that is the thing to do. If you are a 
grower, if you are a manufacturer of this product, that you are 
doing the best science-informed set of practices to reduce the 
risk. And that's all we could ask, is to reduce the risk. We 
know significant risk factors. We know some things that can 
reduce the opportunity for those significant risk factors to 
result in fecal contamination on the spinach field and E. coli 
to come with it.
    We can only ask the manufacturer--rather, the growers in 
the field to do the same level of public health protection that 
we demand of our processing as well. There is a risk that is 
ongoing. Twenty outbreaks, 11 years. We have some tools to put 
into place to reduce that risk. Will it prevent every outbreak? 
Maybe not. But it will certainly reduce the risk.
    Senator Burr. Again, I thank the three of you. I thank the 
Chairman for his indulgence.
    The Chairman. Thank you very much and I too, thank the 
three witnesses for their time and particularly Dr. Brackett 
and Dr. King, for staying around to be a part of the 
questioning that came up from the local testimony that we had 
as well. So we thank you all for being here.
    We'll move on to the third panel and I will introduce the 
witnesses all at once. They'll give their statements and then 
we'll move on to questions. I'm very excited to hear about the 
innovative products that have been developed by the members of 
this third panel.
    For the panel, because of the time of day, I would hope 
that all of you would keep within the 5-minute presentation 
limit and maybe since we have full copies of what you wrote, if 
you're longer than that, perhaps you can summarize for us. 
Because you are the exciting part of this and I assure you that 
people will read to see what inventions there are out there. So 
if you would help us with that, that would give us some time 
for questions.
    This is the order that people will be speaking in: Dr. 
Robert Whitaker, who is the President of MissionStar 
Processing, LLC, which is a contract, value-added vegetable 
processing company located in Salinas, California and Yuma, 
Arizona. MissionStar Processing is a joint venture between 
NewStar Fresh Foods and Missionero, two Salinas-based grower/
shippers. The company was formed in early 2006 to process both 
companies' valued-added conventional and organic salads. 
MissionStar produces a wide array of Spinach Spring Mix and 
Blended Baby Leaf salads and specialties for food service 
distributors and private label products for a number of retail 
customers. Dr. Whitaker received his Ph.D. in Biology from the 
State University of New York at Binghamton in 1982. Dr. 
Whitaker will discuss the impact of the recall on his business 
and what could be done in the future to prevent or contain 
outbreaks associated with fresh produce.
    Ms. Terri-Anne Crawford is Vice President and Chief 
Operating Officer of Franwell, Inc. Franwell has more than 10 
years invested in research and development of radio-frequency 
identified technologies--RFID. Franwell is an Associate Member 
of the University of Florida Research Center for Food 
Distribution and Retailing, which is CFDR, and is engaged in an 
ongoing project testing the use of radio frequency 
identification technology as it relates to each link of the 
food supply chain. Prior to joining Franwell, Crawford worked 
for Publix Supermarkets for 23 years, where she was responsible 
for the development of Publix RFID strategy and worked with the 
University of Florida to design and deploy the V2 Project, 
which is testing the benefit of using the EPC Global Network 
and the fresh produce supply chain. She'll discuss how RFID 
technology can be used to track and trace food products and 
facilitate a recall in the event of an outbreak.
    Mr. Jeff Palmer is President and General Manager of DayMark 
Safety Systems, a company of 140 employees that has experienced 
900 percent growth under his leadership. Mr. Palmer became 
Manufacturing Manager for both DayMark and Century Marketing in 
1992 and General Manager of DayMark in 1999. Much of DayMark's 
success was due to the innovation and introduction of Dissolve-
A-Way label technology. Mr. Palmer and his team were an Ernst & 
Young Entrepreneur of the Year finalist in 2002. Mr. Palmer is 
a graduate of Florida Tech and a member of the International 
Food Service Manufacturing Association. Mr. Palmer will discuss 
how time and temperature abuse are the two biggest factors in 
foodborne illness outbreaks and how DayMark's TimeStrip product 
can help manage those factors to prevent outbreaks.
    Mr. John Vazzana is President and CEO of Intralytix, Inc. 
Mr. Vazzana has over 35 years of business experience and he has 
been instrumental in transforming startup or small companies 
into profitable, publicly traded corporations. He received a 
Bachelor of Science from the University of Maryland in 1968, 
with a major in accounting. Yes! I'm the only accountant in the 
U.S. Senate. Mr. Vazzana will discuss the bacteriophage 
technology his company developed to kill listeria bacteria on 
ready-to-eat meats. The technology was recently approved by the 
FDA. Congratulations on that.
    Dr. Whitaker, you may begin.

   STATEMENT OF DR. ROBERT WHITAKER, PRESIDENT, MISSIONSTAR 
                    PROCESSING, SALINAS, CA

    Dr. Whitaker. Good afternoon, Mr. Chairman, Senator Burr 
and Senator Isakson. My name is Dr. Robert Whitaker and I am 
President of MissionStar Processing, a value-added, fresh cut 
vegetable processing company based in Salinas, California. 
MissionStar Processing is a joint venture of Salinas grower/
shippers New Star Fresh Foods and MissionArrow Vegetables, to 
process their value-added organic and conventional fresh 
salads.
    Our company produces a variety of spinach, spring mix and 
blended baby leaf salads and specialties for food service 
distributors and private label products for a number of retail 
customers. I am also the immediate past Chairman of the 
International Fresh Cut Produce Association, which recently 
merged with the United Fresh Fruit and Vegetable Association to 
form United Fresh Produce Association or United Fresh. 
Together, we have combined forces to deliver the highest level 
of food safety and scientific expertise to our industry.
    First let me address the human impact of illnesses 
associated with this outbreak. We cannot ever forget that more 
than 200 people in 26 States became seriously ill and three 
people died, directly from eating one of our industry's 
healthiest products. Any one of us in the business of growing, 
marketing and selling ready-to-eat foods must embrace the 
importance of our own personal actions in reducing the risk of 
that happening again.
    Two months ago, the FDA took the unprecedented action to 
advise consumers not to consume any fresh-bagged spinach. That 
advice arose from the immediate concern that a serious E. coli 
O157:H7 foodborne disease outbreak was underway and that 
government officials could not tell exactly where the 
contaminated product might be in the marketplace. Unlike a 
traditional food recall of only one product that was directly 
implicated in an outbreak, the FDA felt the proper caution 
required warning consumers against an entire produce commodity 
category.
    In hindsight, we now know a whole lot more about the scope 
and source of the outbreak. The FDA has since confirmed that 
all contaminated product in this outbreak was produced in one 
processing plant, indeed, in 1 day. All spinach processed in 
the plant on that day came from four farms. While we continue 
to investigate exactly how that contamination might have 
occurred, we know that contamination was limited to a very 
small part of the fresh spinach supply. Only product that was 
processed by one company and from 1 day's production.
    Yet, despite the actual narrow cause of the outbreak, the 
entire fresh spinach industry has suffered a tremendous blow. 
Growers and processors of fresh spinach that had perfectly safe 
product in the marketplace, including my company, pulled our 
product from retail shelves, warehouses, processing plants, and 
even stopped harvesting. I am proud of the way our entire 
industry responded to FDA's immediate concern but I'm also 
concerned that we did not collectively narrow this outbreak and 
communicate to all consumers that it was safe to consume 
spinach that was not implicated in the recall.
    Two months later, we are all still suffering from a loss of 
market confidence due to fears about general spinach safety 
that were unwarranted by the facts of the outbreak.
    Looking to ways to prevent future outbreaks, let me state 
clearly that food safety is the produce industry's very top 
priority. Our industry has an extraordinary safety record 
providing American consumers over 6 million bags of fresh salad 
every day. But we are committed to further reducing any risk 
associated with our products. We are constantly working to 
enhance and improve our performance in growing crops in the 
field, carefully harvesting and handling them for distribution, 
packaging and processing commodities into convenient ready-to-
eat products and maintaining the safest possible delivery chain 
all the way to the consumer's table.
    For example, our farmers are strongly urged to follow good 
agricultural practices or GAPs as we've heard them called today 
that have been reviewed by academic scientists and regulatory 
officials to help assure fresh produce safety. My company, 
MissionStar and our colleagues in the fresh cut processing of 
produce follow strict food safety systems in their processing 
plants, including rigorous HACCP or hazard analysis critical 
control point systems and GMPs, your good manufacturing 
practices, to prevent food contamination from occurring.
    In the fresh processing plants, produce companies take 
special precautions, such as removing dirt or other 
contaminations that can be sorted out and found. Raw product 
then goes through a vigorous washing process in the plant, 
often rinsed three times in chlorinated water to help ensure 
the product is clean and free of pathogens, then careful 
temperature controls monitored throughout the distribution 
chain, shipping produce in refrigerated trucks to retail 
markets and restaurants.
    It is critical that we begin to look at lessons learned 
from this episode, work with Congress, FDA, CDC, USDA and 
others to find the right tools to prevent future outbreaks and 
minimize the damage to whole food categories, should a similar 
situation unfold in the future. Federal research dedicated 
specifically to fresh produce food safety is vital to making 
advancements in preventing future foodborne outbreaks 
associated with produce commodities.
    Unfortunately, current funding is not sufficient to tackle 
the urgent need for additional research. For example, in fiscal 
year 2006, USDA ARS discretionary funds available for 
intramural fresh produce food safety research were only about 
$2 million. USDA CSREES has funded only about $2.5 million in 
extramural fresh produce food safety projects in the past 5 
years. At FDA CFSAN, which in prior years has had discretionary 
funding available for targeted intramural and extramural food 
safety research, we understand that no money is now available 
for fresh produce food safety research. Therefore, research 
funding dedicated specifically to fresh produce food safety is 
a top priority of the produce industry.
    Finally, in looking at the impact of this outbreak, we 
believe a very important principle is at stake. Companies must 
not be penalized for doing the right thing when asked by public 
health agencies. Legally, spinach growers and marketers that 
were not subject to this food recall were perfectly in their 
right to keep selling product but they followed the direct 
request from FDA to help consumers avoid all spinach when it 
was unclear where a contaminated product might have been in the 
market. Yet these companies, my company, suffered significant 
financial losses, even though we are not in any way implicated 
in this outbreak. Ironically, those companies whose products 
were not implicated in a food recall may not be insured for 
their losses. The extraordinary circumstances surrounding this 
outbreak should leave the Congress to consider compensation for 
those who suffered losses, pulling safe and healthy spinach 
from the marketplace. There is ample precedent for compensating 
businesses when government action has forced an expensive, 
private action for the sake of public health. We urge you to 
consider this important principle.
    In conclusion, Mr. Chairman, one of the major lessons we 
must learn from this is that our entire industry faces this 
food safety challenge together. It should be abundantly clear 
that outbreaks don't just affect the one company who introduces 
the product to the market or the one sector of the industry or 
the one single commodity or one single region. Our entire 
industry is dependent upon our weakest link.
    We look forward to working with you and the committee in 
the coming months as we constantly seek ways to enhance the 
safety of the food supply and bring Americans great tasting, 
healthy and safe fresh fruits and vegetables that help improve 
their health. Thank you, sir.
    [The prepared statement of Dr. Whitaker follows:]

            Prepared Statement of Robert J. Whitaker, Ph.D.

                              INTRODUCTION

    Good afternoon Mr. Chairman and members of the committee, my name 
is Dr. Robert Whitaker and I am President of MissionStar Processing, a 
value-added fresh-cut vegetable processing company based in Salinas, 
California. MissionStar Processing is a joint venture of Salinas 
grower-shippers NewStar Fresh Foods and Misionero Vegetables to process 
their value-added organic and conventional fresh salads. Our company 
produces a variety of spinach, spring mix and blended baby leaf salads 
and specialties for foodservice distributors and private label products 
for a number of retail customers.
    I received my Ph.D. in biology from the State University of New 
York at Binghamton in 1982, and have spent my career in microbial and 
plant biochemical genetics, the use of biotechnology to develop new 
plant varieties, and management of food safety/quality assurance 
operation in the processing of fresh value-added vegetables. In the 
past 5 years, I have been responsible for overall process operations of 
our company's processing business and overseen the construction of two 
state-of the-art value-added vegetable processing facilities.
    I am also the immediate past chairman of the International Fresh-
cut Produce Association, which recently merged with the United Fresh 
Fruit & Vegetable Association to form United Fresh Produce Association 
(United Fresh). Together, we have combined forces to deliver the 
highest level of food safety and scientific expertise to our industry. 
Our association is led by a Board of Directors representing leaders 
from every sector of the industry, a 50-member Food Safety and 
Technology Council including scientific experts from our member 
companies, and an expert staff food microbiology, plant sciences, 
nutrition and health, and much more.
    I want to compliment the committee today for holding this very 
timely hearing given the ongoing focus on food safety across the 
industry, and the collective response of government and industry to the 
recent E. coli O157:H7 foodborne disease outbreak associated with one 
fresh spinach product.
    First, let me address the human impact of illness associated with 
this outbreak. We cannot ever forget that more than 200 people in 26 
states became seriously ill, and several died, directly from eating one 
of our industry's healthiest products. The consequences of that fact 
alone are huge, and any one of us in the business of growing, marketing 
and selling ready-to-eat foods must embrace the importance of our own 
personal actions in reducing the risk of that happening again.
    That is a commitment that my company and our entire team of 
officers and associates take seriously every day, and it is a 
commitment that our entire industry is making to consumers of our 
products. Growers, processors, retailers, restaurants and trade 
associations that represent our companies across this industry will 
simply do everything we know how to minimize the risk of something like 
this happening again. As scientists, we know that one cannot achieve 
zero risk with anything in life, but we will work hard to drive risk as 
low as possible.

                            INDUSTRY IMPACT

    The committee asked me to share some sense of the impact of this 
outbreak on our business and the industry, and provide thoughts on ways 
to prevent or more quickly contain future outbreaks.
    Two months ago, the FDA took the unprecedented action to advise 
consumers not to consume any fresh bagged spinach. That advice arose 
from the immediate concern that a serious E. coli O157:H7 foodborne 
disease outbreak was underway, and that government officials could not 
tell exactly where the contaminated product might be in the 
marketplace. Unlike a traditional food recall of only product that was 
directly implicated in an outbreak, FDA felt that proper caution 
required warning consumers against an entire produce commodity 
category.
    Why did FDA issue such a broad warning? At the outset, CDC and FDA 
were faced with a terrible mass of confusion--strong evidence of a 
growing outbreak of serious illness and possible death, strong 
circumstantial evidence linking it to fresh bagged spinach, but with 
confounding factors of several different brands and many different days 
of production potentially implicated by bagged product still in 
patients' refrigerators. The public health agencies acted in their best 
knowledge to protect public health.
    With the benefit of hindsight, we now know a whole lot more about 
the scope and source of the outbreak. FDA has since confirmed that all 
contaminated product in this outbreak was produced in one processing 
plant--on 1 day. All spinach processed in the plant on that day came 
from a maximum of four farms. While we continue to investigate exactly 
how that contamination might have occurred, we know that contamination 
was limited to a very small part of the fresh spinach supply--only 
product that was processed by that one company from one day's 
production.
    Yet, despite the actual narrow cause of the outbreak, the entire 
fresh spinach industry has suffered a tremendous blow. Growers and 
processors of fresh spinach that had perfectly safe product in the 
marketplace, including my company, pulled our product from retail 
shelves, warehouses, processing plants, and even stopped harvesting. I 
am proud of the way our entire industry responded to FDA's immediate 
concern, but also concerned that we did not collectively narrow this 
outbreak and communicate to consumers that it was safe to consume 
spinach that was not implicated in the recall. Two months later, we are 
all still suffering from a loss of market confidence due to fears about 
general spinach safety that were unwarranted by the facts of this 
outbreak.
    We strongly urge the committee to work with FDA, CDC and other 
agencies to more quickly limit the scope of concern in an outbreak such 
as this. Long-term, public health will not be well-served by consumers 
losing confidence in entire fresh produce categories because we fail to 
limit the damage when something does go terribly wrong with one 
company's products.

                  PRODUCE INDUSTRY'S FOOD SAFETY FOCUS

    Looking to ways to prevent future outbreaks, let me state clearly 
that food safety is the produce industry's very top priority. We strive 
every day to bring fresh fruits and vegetables to consumers around the 
world that are safe, wholesome, nutritious and great-tasting. We are 
constantly working to enhance and improve our performance in growing 
crops in the field, carefully harvesting and handling them for 
distribution, packaging and processing commodities into convenient, 
ready-to-eat products, and maintaining the safest possible delivery 
chain all the way to the consumer's table. Our food safety commitment 
runs from field to table, and requires the active management of every 
player along the distribution chain.
    Food safety is a process of continuous improvement for our 
industry, and we are constantly striving through industry and 
government research and process operations improvement to further 
reduce any potential risk.

     Our farmers in the field are urged to follow strict ``Good 
Agricultural Practices'' (GAPs) that are reviewed by academic 
scientists and regulatory officials to help assure fresh produce 
safety. Today, we are in a constant process to update, strengthen and 
quantify these practices for specific commodities.
     My company MissionStar and our colleagues in the fresh-cut 
processing of produce follow strict food safety systems in their 
processing plants, including rigorous HACCP (Hazard Analysis Critical 
Control Point) systems and GMPs (Good Manufacturing Practices) to 
prevent food contamination from occurring.
     In these fresh processing plants, produce companies take 
special precautions, such as removing dirt or other contamination that 
might be found. Raw product then goes through a vigorous washing 
process in the plant, often rinsed three times in chlorinated water, to 
help ensure the product is clean and free of pathogens.
     Then, careful temperature control is monitored throughout 
the distribution chain, shipping produce in refrigerated trucks to 
retail markets and restaurants.
     Because fresh produce is often consumed uncooked in its 
raw state, everyone handling produce must prevent cross-contamination 
from raw or undercooked meats, used cutting boards, and even dirty 
hands that may be carrying bacteria. The produce industry is a strong 
supporter of the government-industry Partnership for Food Safety 
Education, which sponsors the Fight BAC food safety consumer education 
initiative.

    Our goal when it comes to food safety is that no one would ever 
become sick from consuming our products. We take our responsibility 
seriously to provide the safest possible foods to each and every 
consumer every day. That is an enormous task when you consider what it 
takes to feed America's produce consumers. While we are proud of our 
safety record in producing some 6 million bags of salad for Americans 
every day, we will never be satisfied if even one consumer gets sick 
from eating our products.

                               NEXT STEPS

    It is now critical to begin to look at lessons learned from this 
episode, working with Congress, FDA, CDC, USDA, and others to find the 
right tools to prevent future outbreaks, and to also minimize the 
damage to whole food categories should a similar situation unfold in 
the future.
    Federal research dedicated specifically to fresh produce food 
safety is critical to making advancements in preventing future 
foodborne outbreaks associated with produce commodities. Over the 
years, the congressional agricultural appropriations budget has been 
the primary source of funding for such research. In addition, USDA has 
the ability to allocate critical funding targeted at fresh produce food 
safety through several different research arms, mainly CSREES and ARS. 
Unfortunately, current funding is not sufficient to tackle the urgent 
need for additional research.
    For example, in fiscal year 2006, USDA ARS discretionary funds 
available for intramural fresh produce food safety research were only 
about $2 million. USDA CSREES has funded only about $2.5 million in 
extramural fresh produce food safety projects in the past 5 years. At 
FDA CFSAN, which in prior years has had discretionary funding available 
for targeted intramural and extramural food safety research, we 
understand that no money is now available for fresh produce food safety 
research.
    Therefore research funding dedicated specifically to fresh produce 
food safety is a top priority of the produce industry. In particular, 
these funds could be distributed among the Federal food safety research 
organizations which already have the appropriate infrastructure for 
further targeted distribution of the funds. These include:

     USDA ARS National Program 108 Food Safety that would be 
further distributed to ARS Research Centers and the National Alliance 
for Food Safety and Security. These entities already constitute the top 
U.S. researchers in the area of fresh produce food safety.
     USDA CSREES, distributed through National Research 
Initiative's Food Safety (32.0) and Epidemiological Food Safety (32.1) 
programs. This funding should be applied to the examination of 
microbial ecology and control as it relates to the introduction, spread 
and persistence of E. coli and other human pathogens in the production, 
processing and packaging of foods.
     Funding for FDA CFSAN could be utilized for laboratory and 
field food safety research related to areas in which FDA has greater 
historical understanding and involvement, such as post-harvest 
processing operations, transportation and distribution, and product 
handling at retail and foodservice operations. In addition the industry 
would support the establishment of the FDA Center Food Safety 
Excellence to be housed at the Western Institute for Food Safety and 
Security Center in UC Davis.

    Finally, please allow me to raise one important point that may be 
beyond this committee's purview, but is an essential issue for the 
Congress.
    In looking at the impact of this outbreak, we believe a hugely 
important principle is at stake--companies must not be penalized for 
doing the right thing when asked by public health agencies. Legally, 
spinach growers and marketers that were not subject to this food recall 
were perfectly in their right to keep selling product. But, they 
followed the direct request from FDA to help consumers avoid all 
spinach when it was unclear where contaminated product might be in the 
market. These companies--my company--suffered significant financial 
losses even though we were not in any way implicated in this outbreak.
    How do I explain to my owners that all the expensive investments 
we've made in food safety in our own growing operations and processing 
plants did not prevent us from suffering the same losses as those 
directly implicated? This was a de facto recall across an entire 
industry, although the entire industry was not responsible for 
introducing contaminated food into commerce. And ironically, many 
companies in my industry appear not to be covered by insurance, simply 
because they were NOT part of the formal recall.
    Many suggest that the extraordinary circumstances surrounding this 
outbreak should lead the Congress to compensate those who suffered 
extraordinary losses pulling safe and healthy spinach from the 
marketplace. There is ample precedent for compensating businesses when 
government action has forced an expensive private action in the sake of 
public health. We urge you to consider this important principle as 
well.

                               CONCLUSION

    Mr. Chairman, one of the major lessons we must learn from this is 
that our entire industry faces this food safety challenge together. It 
should be abundantly clear that outbreaks don't just affect the one 
company who introduces product to the market, or one sector of the 
industry, or one single commodity, or one single region. Our entire 
industry is dependent upon our weakest link--our lowest common 
denominator.
    Growers must realize that we are growing ready-to-eat products that 
are consumed raw. Processors must realize that due diligence means 
personally knowing your raw product has been grown to meet the highest 
agricultural standards, and then employing state-of-the-art processing 
technologies. Retailers and foodservice companies must realize that 
food safety costs money, and when they want to buy safe foods, they 
must pay for safe foods. And consumers must count on the government and 
private sector to work together to bring the very best science 
available to ensuring food safety, without the false illusion that 
anything can ever be 100 percent without some risk.
    We look forward to working with you and the committee in the coming 
months as we constantly seek ways to enhance the safety of the food 
supply and bring Americans great tasting, healthy and safe fresh fruits 
and vegetables to improve their health.

    The Chairman. Thank you.
    Ms. Crawford.

STATEMENT OF MS. TERRI-ANNE CRAWFORD, VICE PRESIDENT AND CHIEF 
       OPERATING OFFICER, FRANWELL, INC., PLANT CITY, FL

    Ms. Crawford. Mr. Chairman, Senator Burr, thank you for the 
opportunity to testify today and thank you for your attention 
to the issue of food safety and your interest in health 
technology can be deployed to potentially help contain 
outbreaks of foodborne illness and particularly facility 
recalls when an issue is discovered.
    I'd like to focus my statement today on three specific 
areas that highlight how IT solutions are being developed and 
could potentially be used to improve food safety and recalls.
    The first involves using a shared network of information to 
track the movement of food through the supply chain. The second 
involves using RFID to facilitate the capture and accuracy of 
the information within that network. Finally, the third 
involves the use of RFID enabled temperature tracking devices 
to monitor the handling of product throughout the supply chain.
    As Senator Enzi pointed out, I'm from Franwell. Franwell is 
a technology development company based in Plant City, Florida. 
We offer technology products and services primarily to the food 
and pharmaceutical industry. We have a particularly close 
affiliation with the fresh food industry. We're also a 
technology partner for the Georgia Tech Research Institute and 
as you pointed out, the University of Florida's Center for Food 
Distribution and Retailing. Franwell is also an active member 
of several industry groups, including United Fresh Fruit and 
Vegetables.
    I joined Franwell in March of this year. Prior to that, I 
was with the Information Technology Department at Publix for 23 
years and in my career there, I was responsible for all the 
strategic planning and implementation of all the technology in 
Publix eight distribution centers and 24 warehouses. So I have 
extensive background in supply chain management.
    Now to get back to today's topic and the points I would 
like to make. First, tracking product through a shared network. 
Before food product reaches your dinner table, it has been 
through an expansive supply chain with many links along the 
way. Imagine the journey your bagged salad takes. Starting in 
the field, lettuce and spinach is harvested and then taken to a 
processing plant. Once processed, it is then placed in a 
distribution center, loaded on to a truck, only to end up in 
another distribution center and on another truck before it ends 
up on your grocery shelf. Trust me, that's the short route.
    Is all this movement easy to track? Well, quite frankly, 
no. In today's supply chain, the individual links do a fair job 
of tracking the product within the confines of their 
organization and their own inventory tracking systems. But load 
that product on a truck destined for another company and you've 
just lost visibility of the product. When it arrives at its new 
destination, it begins a whole new life within the confines of 
their inventory tracking system, with very little--if any--ties 
to its roots.
    In order to execute any large-scale recall in a timely 
manner, the real key is an infrastructure that provides a 
network of shared data about product and its life cycle. If the 
shipment data about the product is available in a shared 
network, that product can quickly and efficiently be tracked 
and removed from the supply chain. Ideally what you want to 
happen is, all the tainted product is quickly removed, safe 
product is still available and the result is less loss to the 
industry and prevention of the more devastating loss of lives.
    Franwell has been involved in an RFID trial led by the 
University of Florida CFDR. The goal of this research project 
has been to prove the viability of sharing this level of 
information across the supply chain. The project is called, 
Visibility Validated or V2. The project tracked shipments from 
three fresh produce suppliers, one of them coincidently, in 
Salinas, California, to a retailer's produce distribution 
center. Although on a small scale, the research project 
demonstrated that it is possible to use a network to share this 
data among trading partners.
    Next I will address using RFID for the accurate and 
efficient data capture. I said earlier that companies do a 
pretty good job of tracking product within their own 
organizations. But many of the processes today are manually 
intensive and when data is captured manually, mistakes can be 
made. RFID technology involves placing a tag on product cases 
that contain a tiny computer chip and an antenna. The antenna 
enables the chip to transmit information to a reader and then 
pass it to a computer that can make use of it. This does not 
require contact between the reader and the tag.
    RFID technology is not new. It's been around since World 
War II. What is new is the mainstream use of RFID that we've 
come across every day. RFID is used for automated toll payment 
systems, ID badges with secured entry to buildings and even on 
the Metro system.
    So when used on product cases, the RFID tag contains 
information about the product, primarily the electronic product 
code or EPC. The EPC is unique to each case of product and is 
used to look up or update information about that case of 
product in computer systems and shared networks. The unique 
code allows us to identify one case of produce from another. 
Once applied, the RFID tags can be read at key points in the 
supply chain, from trading partner to trading partner. I'm sure 
you can imagine how much more valuable it is to identify 
product by a serialized code. Keep in mind, that for this 
information to be useful, it still requires a shared network of 
data, which contains the information about all the active 
electronic product codes within the entire supply chain.
    The technology is not yet perfect but progress is made 
everyday due to the efforts of universities, research labs and 
private companies alike.
    Finally, I'd like to talk about using RFID tags for 
temperature monitoring. Monitoring the cool supply chain with 
RFID temperature monitoring devices is another area where 
Franwell and the Center for Food Distribution and Retailing are 
actively engaged. Temperature is the characteristic of the 
distribution environment that has the greatest impact on the 
storage life and safety of fresh food. Good temperature 
management is, in fact, the most important and yet is the 
simplest procedure for delaying product deterioration and 
preserving product quality and safety.
    RFID can be combined with temperature monitoring devices to 
allow full visibility of a product's life cycle through the 
cold chain in real time. Although E. coli is not a result of 
poor temperature management, other health concerns are a direct 
result of temperature abuses. RFID devices offer standard 
interpretation of data and the read can be automated with the 
same readers that are capturing other information about the 
product.
    Information technologies can be used in many ways to make 
the supply chain more efficient and safer but for these systems 
to be effective, they have to be interoperable and for that, we 
need industry-wide standards. If we're going to have an 
effective RFID track and trace system to facilitate product 
recalls, it has to be uniform from one company to the next and 
in today's global environment, it has to be uniform from one 
country to the next.
    In some cases, the industry has done a very good job in 
producing widely accepted standards. In other cases, it is 
important for government to play a leadership role. It is not 
easy and it can be a long and difficult process but 
standardization is critical to widespread implementation of any 
new technology and those standards must stretch beyond company 
and country borders.
    Congress and the Administration can help by encouraging the 
FDA and USDA to work with standards groups. Federal Government 
can also help by sponsoring research efforts, such as the work 
being done at the University of Florida and other universities 
as well as private technology companies.
    Finally, the Federal Government needs to reinforce to 
private industry the importance of cooperating on standards and 
that track and trace of product and ensuring a safe food supply 
should never be a reactive afterthought.
    Thank you for the opportunity to testify today.
    [The prepared statement of Ms. Crawford follows:]

               Prepared Statement of Terri-Anne Crawford

    Mr. Chairman and Mr. Ranking Member, thank you for the opportunity 
to testify today. And thank you for your attention to the issue of food 
safety and your interest in how technology can be deployed to 
potentially help contain outbreaks of foodborne illness and, 
particularly facilitate recalls when an issue is discovered.
    I'd like to focus my statement today on three specific areas that 
highlight how IT solutions are being developed and could potentially be 
used to improve food safety and recalls. The first involves using a 
shared network of information to track the movement of food throughout 
the supply chain. The second involves using RFID to facilitate the 
capture and accuracy of the information within the network. Finally, 
the third involves the use of RFID-enabled temperature tracking devices 
to monitor the handling of product throughout the supply chain.
    Before elaborating on these points, let me first tell you a little 
about my company and my background. Franwell is a technology 
development company based in Plant City, Florida (in the process of 
relocating to Lakeland, Florida). We offer technology products and 
services to the food and pharmaceutical industries, with a particularly 
close affiliation with the fresh food industry. We offer RFID 
integration services to many diverse industries and have developed and 
deployed RFID applications to improve product tracking in the supply 
chain.
    We are a technology partner with the Georgia Tech Research 
Institute (GTRI) and University of Florida's Center for Food 
Distribution and Retailing (CFDR). We started RFID research with GTRI 
in 1993 and continue to work with their signal engineers on developing 
new products and overcoming RFID challenges. Franwell is an Associate 
Member of the CFDR, and is responsible for the contribution, 
installation and maintenance of RFID technology used in the center's 
RFID lab. Franwell also serves as a technology partner for many of the 
Center's research initiatives. The mission of the CFDR is to provide 
the food industry and the scientific community with a unique 
environment for developing knowledge that will assure food quality and 
safety throughout the whole distribution chain. In addition to our 
involvement with academia, Franwell is also an active member of 
industry groups, such as EPCglobal, the Cool Chain Association, United 
Fresh Fruit and Vegetable Association (UFFVA), and Produce Marketing 
Association (PMA).
    I joined Franwell in March of this year, prior to joining Franwell 
I was with the Information Technology Department at Publix Super 
Markets for 23 years. The last 13 years of my career there, I was 
responsible for the strategic planning and implementation of all 
technology in Publix's distribution centers and warehouses, providing 
technology to run more than 8 distribution centers and 20 warehouses, 
shipping product to more than 900 stores. I was also responsible for 
researching RFID in order to determine a corporate strategy for 
implementation of the technology at Publix.
    Now to get back to today's topic and the points I'd like to make.

               TRACKING PRODUCT THROUGH A SHARED NETWORK

    Before a food product reaches your dinner table, it has been 
through an expansive supply chain with many links along the way. 
Imagine the journey that your bagged salad takes--starting in the 
field, lettuce or spinach is harvested and then taken to a processing 
plant, once processed it is then placed in a distribution center, 
loaded onto a truck, only to end up in another distribution center and 
on yet another truck before making it to your grocery shelf. And this 
is the short route, assuming no secondary processing plants, additional 
distribution centers, or consolidation centers are involved and not to 
mention the added journey that imported product takes. Is all this 
movement easy to track? Well, quite frankly, no.
    In today's supply chain, the individual links do a fair job of 
tracking the product within the confines of their organization and 
their own inventory tracking systems, but load that product on a truck 
destined for another company and you have just lost visibility of the 
product, where it came from and where it is going. When it arrives at 
its new destination it begins a whole new life within their inventory 
tracking system, with very little, if any ties to its roots. In the 
case of a foodborne illness outbreak or any other need for recall, the 
thing that is missing is complete visibility of where any of the 
tainted product is within a complex supply chain that is in constant 
movement every minute of every day.
    In order to execute any large-scale recall in a timely manner, the 
real key is an infrastructure that provides a network of shared data 
about product and its life cycle. If the shipment data about product is 
available in a shared network, showing where every occurrence of a 
particular lot of product is located, that product can quickly and 
efficiently be removed from the supply chain. Ideally, all tainted 
product is quickly removed and safe product will still be available, 
resulting in less losses to industry and in the case of foodborne 
illness, preventing the even more devastating loss of lives.
    Franwell has been involved in an RFID trial led by the University 
of Florida's CFDR. The goal of this research project has been to prove 
the viability and value of sharing this level of information across 
supply chain trading partners. Dubbed Visibility Validate or V2, the 
project tracked shipments from three fresh produce suppliers to a 
retailer's produce distribution center. Data about the shipment and 
receiving of product was posted to a shared network and everyone 
involved had access to the data via the Internet. Although only one 
product code was tracked from each of the suppliers, the research 
project demonstrated that it is possible to use a network to share this 
data among trading partners.
    This type of research is very important and needs to be expanded. 
We need to prove it can scale to support the enormous amount of data 
that would be collected once many or all products were being tracked 
through a network. There also needs to be continued effort on defining 
exactly what information is the most important to capture, at what 
points in the supply chain, and the technology needed for this much 
data to be aggregated and accessed efficiently.

              RFID FOR ACCURATE AND EFFICIENT DATA CAPTURE

    I said earlier that companies do a pretty good job of tracking 
product within their own organizations, but even to track the product 
internally, many of the processes today are manually intensive. 
Introducing new points for capturing this data can be very costly due 
to the manual nature that is used to do so. When tracking product from 
the field to a processing plant or distribution center, there are many 
steps along the way and when this data is being captured manually, 
mistakes can be made.
    RFID technology involves placing a tag on product cases that 
contain a tiny computer chip and an antenna. An RFID reader or scanner 
is a proximity reader, which means it does not require contact between 
the reader and the tag. This ability to read the information from the 
tags without line-of-sight or direct contact is the primary advantage 
of RFID tags for identifying product. The antenna enables the chip to 
transmit information to a reader. The reader converts the radio waves 
returned from the RFID tag into a form that can then be passed to 
computers that can make use of it. RFID technology is not new; it has 
been around since World War II. What is new is the mainstream use of 
RFID technology that we witness every day. RFID is used for automated 
toll payment systems, ID badges, secured entry to buildings, and even 
for transportation on the Metro System.
    When used on product cases, the RFID tag contains information about 
the product; standards call for an Electronic Product Code or EPC. The 
EPC is unique to each case of product and is used to look up or update 
information about that case of product in computer systems and shared 
networks.
    For example, today if you purchase a 16 oz. can of green beans, 
there is a bar-code on that can. The can came out of a case, and there 
was a barcode on the case. The bar-code actually contains a Global 
Trade Identification Number, known as a GTIN, which identifies what 
that product is. Every 16 oz. can of green beans from a particular 
manufacturer will have the exact same GTIN. Scanning the bar code will 
tell you the product and can be connected to information systems to 
provide information such as the price or inventory count, but it won't 
give you any unique characteristics about that particular can or case 
of cans. The EPC on the other hand, is designed to identify not only 
the product, but a particular instance or occurrence of the product by 
including a serialized code along with the GTIN.
    I am sure you can imagine how much more valuable it is to identify 
a product by a serialized code, rather than just knowing where all 
canned green beans are, you could know where all the cans of green 
beans, processed on a particular day by a certain manufacturer are. 
Keep in mind, that for this information to be useful to track and trace 
product, it requires a shared network of data which contains 
information about all the active Electronic Product Codes within the 
entire supply chain.
    In addition to the value of the EPC and a shared network, RFID adds 
value through automation. Today, much of the process for tracking 
product harvested from the field is captured on paper and paper records 
are notoriously error-prone. Even if the information is ultimately 
entered into a computer system, handwriting is hard to read, pages get 
lost, data-entry falls behind or the information gets keyed 
incorrectly.
    With RFID, cases or totes could be tagged with a unique EPC before 
being taken into the field at harvest. By knowing which totes are taken 
to which area or field, those EPCs could be associated with the 
harvester and the field. Or a more flexible method would be to have 
handheld RFID readers right out in the field and associating the EPC on 
the case or tote with that product from that field on that day and 
time. GPS technology could even be added to validate the exact 
harvesting location. When the cases packed in field are the actual 
cases that will ultimately be shipped to your local grocery store, this 
same RFID tag can be used to track the product through its entire 
journey. If product is harvested and sent for further processing, then 
the tracking would have to continue through processing and be 
associated with a new EPC tag applied to the finished product, say a 
case of bagged salad.
    Once applied, the RFID tags can be read at key points in the supply 
chain and the network updated along the way during key observation 
events. In the V2 project, the tag applied by the fresh produce 
supplier was read when it was staged for shipment and again when 
product was shipped out. The next observation occurred when the tag was 
read again, automatically with readers on the dock doors, once it 
arrived at the retailer's distribution center.
    The technology isn't perfect yet, there are still some issues with 
reading product with high water content or metal packaging, but 
progress is made every day due to the efforts of universities, research 
labs and private companies alike. Government can help move the 
technology forward, by sponsoring research efforts that are taking 
place and staying involved and supporting the standards bodies that are 
working diligently to provide an infrastructure to track product 
through the supply chain.

                  RFID TAGS FOR TEMPERATURE MONITORING

    Monitoring the ``cool'' supply chain with RFID temperature 
monitoring devices is another area where Franwell and the CFDR are 
actively engaged. Temperature is the characteristic of the distribution 
environment that has the greatest impact on the storage life and safety 
of fresh foods. Good temperature management is in fact, the most 
important, yet the simplest procedure for delaying product 
deterioration. Temperature is also the one factor that can be easily 
and promptly controlled. Preservation of fresh product quality and 
safety can only be achieved when the product is maintained under its 
optimum temperature as soon as possible after harvest or production. 
RFID can be combined with temperature monitoring devices to allow full 
visibility of a product's life cycle through the cold chain in real 
time. Although 
E. coli is not a result of poor temperature management, other health 
concerns are a direct result of temperature abuses. RFID temperature 
monitoring devices can be used to ensure that product reaching the end-
consumer has not suffered such abuses, resulting in safer product.
    Temperature monitoring devices are widely used today, but the ones 
in use are not as robust or easy to use as the RFID monitoring devices 
that are available and being improved. The goal of RFID-enabled 
monitoring is to reduce the reading time of temperature devices, giving 
the receiver in a warehouse an initial accept/reject indication real-
time, without delay. Current practices might deploy one or two 
monitoring devices per trailer load of product, those devices will tell 
you what the temperature has been in that area of the trailer, but will 
not tell you the temperature of the individual cases or even certain 
pallets of product and they must be retrieved and read manually.
    Our vision includes the use of more devices, at the pallet level 
and eventually even the case level and applying these labels earlier in 
the process, back to the cooler at the shipper location. RFID devices 
also have the advantage of offering standard interpretation of data, 
rather than leaving the interpretation up to the receiving dock 
personnel. Also, the read can be automated, hopefully with the same 
readers that are being used for tracking product, providing more reads 
and enabling more consistent quality procedures overall. This 
automatically captured data could be used by software systems to 
provide a higher-level of business intelligence that will provide for 
further interpretation of all temperature fluctuations and the effect 
on product quality and safety.
    Information technologies can be used in many ways to make the 
supply chain more efficient and safer. But for these systems to be 
effective, they have to be interoperable. And to be interoperable, we 
need industry-wide standards. Without such standards, one company's 
readers won't read another company's tags, and so on. For example, if 
we're going to have an effective RFID track-and-trace system to 
facilitate product recalls, it has to be uniform from one company to 
the next and in today's global economy, it has to be uniform from one 
country to the next. This is a tremendous challenge that is being taken 
on by industry standards groups, such as EPCglobal.
    In some cases, industry has done a very good job in producing 
widely-accepted standards. In other cases, it's important for the 
Government to play a leadership role. It isn't easy and can be a long 
difficult process, but standardization is critical to widespread 
implementation of any new technology and those standards must stretch 
beyond company and country borders.
    Congress and the Administration can help by encouraging the FDA and 
USDA to work with standards groups. Federal Government can also help by 
sponsoring research efforts, such as the work being done at the 
University of Florida and other universities and private technology 
companies focused on developing important new technologies. And 
finally, the Federal Government needs to reinforce to private industry 
the importance of cooperating on standards, and that track and trace of 
product and ensuring a safe food supply should never be a reactive 
afterthought.
    Thank you again for the opportunity to testify today. I'd be happy 
to answer any questions you may have.

    The Chairman. Thank you.
    Mr. Palmer.

 STATEMENT OF JEFF PALMER, PRESIDENT, DAYMARK SAFETY SYSTEMS, 
                       BOWLING GREEN, OH

    Mr. Palmer. Mr. Chairman and distinguished members of the 
committee, I want to thank you for holding this hearing and 
giving us the opportunity to express our views regarding food 
safety.
    I am Jeff Palmer, President of DayMark Safety Systems, a 
company well known for its expertise in providing solutions for 
safe and efficient food rotation. In fact, DayMark is the No. 1 
provider of products and solutions for safety in food service 
and the restaurants today.
    As you see in the appendix to our statement, we are one of 
four innovative companies belonging to the CMC Group, 
established 27 years ago in Bowling Green, Ohio. DayMark's 
mission is to provide efficient, economical and innovative ways 
to label food in compliance with Federal food codes as well as 
provide additional food safety products, technologies, services 
and solutions for the food service industry.
    We clearly advocate that proper labeling protects consumers 
from foodborne illness outbreaks. Proper labeling proactively 
supports first in, first out food rotation. Proper labeling 
with the HACCP system is a process that uses a combination of 
proper food handling procedures, monitoring techniques and 
recordkeeping to ensure food safety. Proper labeling reduces 
spoilage and food costs when products are dated correctly and 
staff becomes accountable for managing food storage and 
preparation.
    Proper labeling reduces labor, time and costs. Proper 
labeling ensures product freshness and flavor. Proper labeling 
enables food service operators to become compliant with FDA 
regulations. The challenge for government is how to implement 
plans to prevent foodborne illness, including E. coli. Food 
rotation is critical when storing food products because 
improperly stored items can result in food spoilage, which in 
turn, requires additional purchases that can deplete a 
company's resources.
    At DayMark, labeling technology is rapidly evolving. We 
have many new ideas at work to safeguard consumers. We've been 
the innovator in the labeling field since 1997 with the 
introduction of Dissolve-Away and Dissolve-Mark labels. These 
labels are used for dry and cool storage and are ideal for food 
rotation because each label contains space that includes the 
name of the product, used by date and expiration date. But 
unlike permanent adhesive labels, Dissolve-Mark labels dissolve 
in warm water in under 30 seconds and leave no sticky residue, 
which could harbor bacteria on storage containers.
    Other innovations include Dissolve-Away tape, Chill-Check, 
Hot Hold labels, repositionable labels, daily week portion 
bags, disposable grip-to-go, pastry bags, protective gloves, 
OSHA-compliant first aid kits and freezable labels.
    One of our food safety tools in today's discussion is the 
DayMark Timestrip food freshness indicator. Food service 
operators who are interested in an effective method for 
identifying the shelf life of perishable inventory can use 
DayMark Timestrip. The timestrip helps kitchen staff to use 
food products before they are no longer safe to serve. It's a 
visual alarm clock with a universal language.
    In addition to innovation, DayMark brings awareness to the 
food service industry. Our employees are experts in food and 
personal safety and have been trained and certified to help 
food service professionals develop the best systems to fit 
their operational needs.
    At DayMark, we continually assist food service owners, 
managers and employees with complete safety solutions.
    In summation, clearly millions of foodborne illness and 
thousands of hospitalizations and foodborne illness disease-
related deaths tell us that proper safety procedures, 
processes, training, education and tools are needed.
    Finally, the use of products including food rotation 
labeling systems and Timestrip, provided by DayMark Safety 
Systems fully support our government and FDA efforts to 
safeguard consumers. Thank you.
    [The prepared statement of Mr. Palmer follows:]

                  Prepared Statement of Jeff S. Palmer

    Mr. Chairman and distinguished members of the committee, I want to 
thank you for holding this hearing and giving us the opportunity to 
express our views regarding Food Safety: Current Challenges and New 
Ideas to Safeguard Consumers.
    I am Jeff Palmer, President of DayMark Safety Systems, a company 
well known for its expertise in providing solutions for safe and 
efficient food rotation. In fact, DayMark is the #1 provider of 
products and solutions for safety in the food service, or restaurant 
industry today.
    As you can see in the appendix to our statement, we are one of four 
innovative companies belonging to the CMC Group, established 27 years 
ago in Bowling Green, Ohio. Our mission is to provide efficient, 
economical, and innovative ways to label foods in compliance with 
Federal Food Codes as well as to provide additional food safety 
products, services and solutions for the food service industry.
    Primarily, DayMark Safety Systems specializes in products that 
assist food service establishments. Our products are used to provide 
efficient, economical, innovative ways to label foods in compliance 
with food safety standards.
    We clearly advocate that proper labeling:

     Protects consumers from foodborne illness outbreaks.
     Proactively supports ``first in, first out'' (FIFO) food 
rotation.
     Supports operators that use the standard HACCP program. 
The HACCP system (Hazard Analysis Critical Control Points) is a process 
which uses a combination of proper food handling procedures, monitoring 
techniques, and recordkeeping to help ensure food safety. By 
instituting a HACCP system, food service managers can identify areas 
where contamination or growth of microorganisms can occur. Control 
procedures can then be implemented to contain the problem and prevent 
future occurrences. The use of a HACCP system is vital. The Centers for 
Disease Control and Prevention (CDC) estimate that there are between 76 
million cases of foodborne illnesses each year in the United States. 
These instances result in an estimated 325,000 hospitalizations and 
5,000 deaths. This number is staggering, especially when many of these 
illnesses could be prevented with the proper food rotation procedures.
     Reduces spoilage and food costs when products are dated 
correctly and staff becomes accountable for managing food storage and 
preparation.
     Reduces labor time and costs to properly label food 
products in commercial kitchens, which increases compliance.
     Ensures product freshness and flavor.
     Enables food service operators to become compliant with 
FDA regulations.

    Furthermore, food operators using the FIFO method of food rotation 
and food operators following a HACCP program must use labels to comply 
with these methods.
    The challenge for government is how to implement plans to prevent 
foodborne illnesses, including E. coli. According to the world health 
organization, it is estimated that up to 30 percent of all people in 
industrialized countries may be affected by foodborne illness. As I 
stated before, approximately 5,000 people a year die from foodborne 
illness in the United States alone. In addition, it is believed that 
some 1.7 million children worldwide aged 0-15 years die every year as a 
result of diarrhea caused by water or foodborne microorganisms. Most 
all of this sickness and death could be prevented with proper 
procedures.
    Furthermore, food rotation is critical when storing food products 
because improperly stored items can result in food spoilage, which in 
turn, requires additional purchases that can deplete a company's 
resources. Because of this, the value of labeling in storing food 
products is critical. By properly labeling food, food service managers 
will save on food costs, reduce or eliminate cross contamination and 
foodborne illnesses and streamline employee communication across work 
shifts. Our bi-lingual and tri-lingual labels, for example, also remove 
language barriers.
    At DayMark labeling technology is rapidly evolving. We have many 
new ideas that work to safeguard consumers. We have been an innovator 
in the labeling field since 1997 with the introduction of the Dissolve-
A-Way and DissolveMarkTM labels. These labels, used for dry and cold 
storage, are ideal for food rotation because each label contains space 
to include the name of the product, use-by-date and expiration date. 
But, unlike permanent adhesive labels, DissolveMarkTM labels dissolve 
in warm water in under 30 seconds and leave no sticky residue, which 
can harbor harmful bacteria on storage containers.
    Other innovations include Dissolve-A-Way Tape, ChillCheck & HotHold 
Labels, Removeable Labels, Repositionable Labels, Freezable Labels, 
Day-of-the-Week Portion Bags, Disposable Grip2Go Pastry Bags, 
Protective gloves and OSHA compliant First Aid Kits.
    One of our food safety tools most applicable to today's discussion 
is the DayMark Timestrip--food freshness indicator. Food service 
operators who are interested in an effective method for identifying the 
shelf life of their perishable inventory can use DayMark's Timestrip. 
The Timestrip helps kitchen staff identify and use food products before 
they are no longer safe to serve. It also improves monitoring to help 
meet HACCP regulatory standards.
    In addition to innovation, DayMark brings awareness to the food 
service industry. Our employees are experts in food and personal safety 
and have been trained and certified to help food service professionals 
develop the best safety system to fit their operational needs. At 
DayMark, we continually assist food service owners, managers and 
employees with complete safety solutions.
    Three simple rules have been DayMark's cornerstone since inception:

    1. Take care of every customer by the golden rule: treat him or her 
the way we would want to be treated.
    2. Handle every customer with the highest level of efficiency and 
effectiveness.
    3. Lead the development of cutting edge technology and products 
that make the operator more cost-effective and compliant with current 
Federal food codes.

    In summation, clearly the millions of foodborne illnesses and 
thousands of hospitalizations in foodborne disease-related deaths tell 
us proper safety procedures, processes, training, education, and tools 
are needed.
    And finally, the use of products including food rotation labeling 
systems and Timestrip provided by DayMark Safety Systems fully suppport 
our government and FDA's efforts to safeguard consumers.




    The Chairman. Thank you. Great job summarizing.
    Mr. Vazzana.

 STATEMENT OF MR. JOHN VAZZANA, PRESIDENT AND CEO, INTRALYTIX, 
                      INC., BALTIMORE, MD

    Mr. Vazzana. I'd like to thank you, Mr. Chairman, Senator 
Burr and the rest of the committee for an opportunity to talk 
to you about our company and our technology.
    Intralytix was founded in 1998 by a group of business and 
technical leaders in Baltimore, Maryland. Two of the founders 
were Dr. Torrey C. Brown and Dr. J. Glenn Morris. Dr. Brown is 
Chairman of the Board of Intralytix. He is the former Secretary 
of Natural Resources for the State of Maryland and a former 
Assistant Dean of the John Hopkins School of Medicine. Dr. 
Morris is Dean of the School of Public Health at the University 
of Maryland. He is one of the leading experts in infectious 
disease and a specialist in food safety. From 1994 to 1996, he 
was the Director of the Emergency Response Program at the Food 
Safety Inspection Services, U.S. Department of Agriculture and 
played a key role in the preparation of the 1995 USDA 
regulations on microbial safety in meat processing. These 
regulations are commonly known as HACCP.
    Intralytix is a biologics company focused on the 
development of bacteriophage products for the food safety, 
animal health and human health markets. The emergence of 
antibiotic resistant bacteria has created a demand for new 
technologies to address health and safety problems existing in 
these markets. Bacteriophages or as we commonly call them, 
phages, are a class of viruses that occur abundantly in nature 
and attack a bacteria in a strain-specific fashion. A phage 
effective against E. coli O157:H7 will have no effect on 
listeria. Phages are the most ubiquitous organisms on the earth 
today. One milliliter of unpolluted water contains 200 million 
phages. In the environment, phages and their bacterial targets 
have evolved over billions and billions of years. For every 
strain of bacteria, there is a phage that will kill it.
    Phages do not interact with humans, animals or plant cells 
and for this reason, they have a highly favorable safety 
profile.
    Phages were discovered in 1917 by Felix d'Herelle and in 
the 1930s, Elli Lilly had seven phage-based products on the 
market. With the advent of antibiotics, phage technology went 
out of favor in the west but since 1917 and to the present, 
phage therapy has been used widely in Eastern Europe. There has 
never been any serious adverse effect reported from phage 
therapy.
    The company has developed products effective against 
listeria, salmonella and E. coli. In August 2006, FDA approved 
our product, LMP 102. LMP 102 is a phage product effective 
against listeria monocytogenes. Listeria monocytogenes infects 
about 2,500 people each year in the United States. Over 20 
percent of these people die. This represents the first FDA 
approval of a phage product and provides a template for future 
phage-based food additive products.
    ECP-100 is a phage product effective against E. coli 
0571:H7. 
E. coli O157:H7 is a strain of E. coli that is commonly 
associated with contamination of hamburger. It is also the E. 
coli strain that was associated with the outbreak in spinach.
    Intralytix anticipates filing a food addition petition with 
FDA in December ECP-100. Except for the target bacteria, our 
proposed regulation for ECP-100 will be identical to the 
regulation approved by FDA for LMP 102. Our attorneys estimate 
that it will take 18 months to obtain regulatory approval. We 
believe this to be excessive. We believe the Food Contact 
Notification Program should be expanded to include phage 
products. This would reduce the approval process to 
approximately 120 days.
    SPLX-1 is a phage product effective against salmonella. 
Intralytix anticipates filing a food additive petition in June 
2007. Today, a significant percentage of raw poultry sold to 
the consumer is contaminated with salmonella. Even though the 
salmonella is killed if the poultry is properly cooked, the 
secondary or cross contaminations are a major cause of 
salmonella poisoning. Again, we believe a mechanism should be 
adopted that would permit the approval of this product quickly.
    Intralytix has also developed a phage product for chronic 
wounds. The product, WPP 201, targets Venus and diabetic 
ulcers. These chronic wounds quickly develop antibiotic 
resistant infections. The wounds also develop a biofilm that 
protects the bacteria. We believe phages can penetrate the 
biofilm and lyse the antibiotic resistant bacteria. FDA 
recently approved the first human trial. We appreciate the 
responsiveness of the Biologics Group at FDA in approving this 
human trial.
    The use of phages in food safety and medical applications 
makes more effective a widespread, natural process that is 
already occurring on our environment, in our bodies and on our 
food. Each of you in this room hosts billions of phages in your 
body. The virtues of phage lie in their nearly unlimited 
ability to target existing and new bacterial pathogens, the 
complete safety of their use and the ability to develop and 
deploy phage products to counter new bacterial strains quickly.
    Thank you for this opportunity.
    [The prepared statement of Mr. Vazzana follows:]

                   Prepared Statement of John Vazzana

                              INTRODUCTION

    Intralytix, Inc is a biologics company focused on the development 
of bacteriophage-based products for the food safety, animal health, and 
human health markets. The emergence of antibiotic resistant bacteria 
has created a demand for new technologies to address health and safety 
problems existing in these markets.
    Bacteriophages (phages) are a class of viruses that occur 
abundantly in nature and attack bacteria in a species-specific or 
strain-specific fashion. The use of phages in food safety and medical 
applications harnesses and makes more effective a widespread natural 
process that is already occurring in our environment, within our 
bodies, and on our food as we speak. The virtues of phage lie in their 
nearly unlimited ability to target existing and new bacterial 
pathogens, the complete safety of their use, and the ability to develop 
and deploy phage to counter new bacterial threats within a few months 
of detection.
    Phages are the most-numerous life form on earth; some estimates 
place the phage population in the range of between 10\31\ and 10\32\. 
In the environment, phages have evolved in parallel with their 
bacterial targets. They are robust entities that keep in check their 
bacterial-population counterparts and play an important role in the 
balance of all ecosystems.
    Phages interact neither with humans, animals nor with plant cells, 
and therefore have a highly favorable safety profile. Phages have been 
used for several decades in Eastern Europe, and are effective in a 
number of situations where antibiotics are inadequate due either to 
bacterial resistance or poor blood supply; such situations include 
osteomyelitis, diabetic ulcers and severe burns.
    ``Simply stated, phages are viruses that infect bacteria. Like all 
viruses, phages are metabolically inert in their extracellular form and 
reproduce by insinuating themselves into the metabolism of the host 
bacteria. The viral DNA is then injected into the host cell, where it 
directs the production of progeny phages. These phages burst from the 
host cell, killing it and then infecting more bacteria. There are 
innumerable types of phages, each capable of eradicating its host 
bacterial species. They are abundant in the biosphere and can be 
produced on a large scale, very economically. It is important to note 
that phages only attack bacteria and have absolutely no adverse effect 
on humans, animals or the environment.'' Company's Website 
www.intralytic.com.
    Phages were also used in the United States and Europe during the 
early 20th Century. In the 1920s, Eli Lilly had at least seven phage 
products on the market. However, phages fell into disuse with the 
advent of broad-spectrum antibiotics. This was due to at least four 
reasons:

     Broad-spectrum antibiotics were easier to use than were 
phages, each of which have focused, narrow-spectrum activity.
     The medical crisis in wound treatment created by World War 
II, accelerating the demand for broad-spectrum antibiotics.
     Consistency, quality control and purity of phages (and 
phage therapy) were not always maintained.
     There was not broad consensus as to what phages were; two 
prevailing views had phages as either (1) viruses or (2) enzymes. For 
many, the actual nature of phages was settled only with the advent of 
electron microscopy, when the first images of phages (as virus 
particles) were finally obtained.

    With the increasing threats from antibiotic resistant infections, 
phage research and development has increased sharply. Intralytix has 
developed products that address antibiotic resistant infections in 
wounds.
    While phages were largely abandoned in the West, they continued to 
play an important role in the Soviet Union, where Giorgi Eliava 
established a research institute in Tbilisi, Georgia (Republic of 
Georgia) in collaboration with Felix d'Herelle, co-discoverer and 
prolific explorer of phages. That institute, now called the Eliava 
Institute, became the center for research and development of phage 
therapy.
    Today, phage capabilities are still being developed in the former 
Soviet Union, particularly at the Eliava Institute in Georgia. Phages 
are also being explored by several U.S. and European firms, but no 
phages have yet to enter FDA-approved human trials. A couple of firms 
are pursuing veterinary or agricultural applications in the United 
States and/or Canada. It is a principal objective of Intralytix to be 
the first company with phages in FDA-approved human trials.
    Given the media attention to emergent infections and bioterrorism, 
it is not surprising that there has been significant mass-media 
coverage of phage therapy over the past couple years. Recent mention of 
the clinical potential of phages includes (but is not limited to):
    1. Print media

        a. Science
        b. Wired--October 2003
        c. International Journal of Dermatology
        d. LA Times and NY Times
        e. Book: The Killers Within--has a chapter on phage therapy
        f. Recent story (9 December 2003) in the Star-Ledger newspaper 
        in New Jersey

    2. Other media

        a. Television programs

                i. Fox 5 Morning news
                ii. CBS News
                iii. BBC: The Virus that Cures
                iv. 48 Hours
                v. Canadian Discover program
                vi. Dateline Australia
                vii. The Nature of Things

        b. A Canadian/French joint documentary film currently being 
        made on phage therapy. ``Before penicillin became the medical 
        world's darling, crusading doctors crisscrossed the globe armed 
        with bacteriophages, bacteria killing viruses that, when 
        administered to diseased patients via injection or potion, 
        could be powerful healers'' U.S. News and World Report; Return 
        of a killer--Phages may once again fight tough bacterial 
        infections; November 2, 1998.

                               INTRALYTIX

    Intralytix was founded in 1998 by a group of business and 
technology leaders in Baltimore, Maryland. Today the founders make up 
the majority of the Board of Directors. A brief resume of each Board 
member is attached. The initial funding of the Company was provided by 
development partners interested in the development of products that 
would make their products safer. As a result of a development contract 
with Perdue Farms, the Company was able to develop products effective 
against Listeria and Salmonella. Agreements with Alpharma have resulted 
in the development of animal health products effective against 
Salmonella and Clostridium perfringens.

                                FOUNDERS

    Dr. Torrey C. Brown, M.D. is the Chairman of the Board of 
Intralytix. Dr. Brown is the former State of Maryland Secretary of 
Natural Resources and is the former CEO and current chair of Family 
Health International. During Dr. Brown's tenure Family Health 
International grew from $9 M to $100M in annual revenues. He is a 
former Assistant Dean of the Johns Hopkins Medical School and member of 
the Maryland State Legislature, having served for 12 years.
    Dr. J. Glenn Morris, Jr., M.D. is currently the Chairman of the 
Department of Epidemiology and Preventive Medicine at the University of 
Maryland Medical School, as well as Professor of Medicine and Professor 
of Microbiology and Immunology. He is an experienced infectious disease 
physician, epidemiologist, and specialist in food safety. From 1994-
1996 he was Director of the Epidemiology and Emergency Response Program 
at the Food Safety Inspection Service, USDA, and played a key role in 
the preparation of the 1995 USDA regulations on microbial safety in 
meat processing (the HACCP rule).
    Dr. Sulakvelidze, a co-founder of Intralytix, received his formal 
training in microbiology in the former Soviet Union, including a B.A. 
from Tbilisi State University, a Ph.D. from Tbilisi State Medical 
University, and specialized training at the Engelhard Institute of 
Molecular Biology, Russian Academy of Sciences, Moscow, Russia, and the 
University of Maryland School of Medicine, Baltimore, Maryland, USA.
    Dr. Sulakvelidze's research interests are in the broad areas of 
emerging infectious diseases, molecular epidemiology, pathogenesis of 
diseases caused by bacterial enteric pathogens, bacterial toxins, and 
phage therapy. One of the major focuses in Dr. Sulakvelidze's research 
are studies of the potential usefulness of bacteriophages in preventing 
and treating infectious diseases caused by multidrug-resistant 
bacteria. The ability of lytic phages to reduce/eliminate colonization 
with, and treat diseases caused by, vancomycin-resistant enterococci, 
imipenem-resistant Pseudomonas aeruginosa, various Salmonella 
serotypes, and other bacterial pathogens have been studied. Dr. 
Sulakvelidze is also actively involved, in close collaboration with the 
Maryland Department of Health and Mental Hygiene, with studies of 
emerging infectious diseases. These studies include molecular 
epidemiological characterization of selected pathogenic strains by 
modern molecular typing techniques (PFGE, AP-PCR, etc.) and active 
participation in Maryland's Emerging Infectious Diseases Program (EIP) 
sponsored by the CDC.
    Gary Pasternack, M.D., Ph.D., a co-founder of Intralytix, is a 
pathologist with extensive experience as a principal and a consultant 
in biotechnology businesses. Formerly he was the Director of the 
Division of Molecular Pathology at the Johns Hopkins University School 
of Medicine. Dr. Pasternack has served as member or chair of numerous 
review panels for the National Institutes of Health and the U.S. Army 
Medical Research and Materiel Command; he currently serves on a panel 
reviewing SBIR applications for the National Cancer Institute.
    Patrick Hervy, a co-founder of Intralytix, is an experienced 
businessman who holds an MBA from Wharton. He is the founder, Chairman, 
and CEO of XLHealth Corporation. He is a member of the Board of 
Directors of Paragon Biotech, Inc. and has served as the former 
Chairman of MdBio, Inc. He is the former Chief Executive Officer of 
U.S. operations for Thomsen CGR.
    John Woloszyn, JD, has been a business attorney with over 25 years 
experience representing technology-based companies. Mr. Woloszyn is a 
corporate attorney for multiple biotech, medical device, information 
technologies, and Internet companies. He has extensive experience in 
mergers, acquisitions, capital formation and the development of 
emerging growth companies. He is a member of the Board of Directors of 
MdBio, Inc., Chairman of the Board of Directors for Lombard Securities, 
Inc. and Chairman of Primaryimmune Services, Inc. He was a former Co-
Vice Chair of Greater Baltimore Technology Council and member of the 
board of the NASA/Goddard Emerging Technologies Center in Baltimore, 
Maryland.
    Nina Siegler, CFA, a co-founder of Intralytix, is an expert in 
licensing and technology transfer. Ms. Siegler is a former Wall Street 
biotech analyst who later went on to found the technology transfer 
office at the National Institutes of Health. Ms. Siegler is the former 
head of technology transfer for the Johns Hopkins University at 
Homewood.

                           EXISTING PRODUCTS

    As a result of the strategic alliance with Perdue Farms, the 
company has developed products effective against Listeria and 
Salmonella. The products can be used as food safety and animal health 
products. The Listeria product, LMP 102, has been approved by FDA as a 
food additive.
    The FDA approval gives us a template for future food additive 
products. We intend to submit a petition to FDA before the end of 2006 
for an E-coli O157:H7 food safety product. The product can be used on 
both red meat, and fruits and vegetables such as lettuce and spinach. 
Our proposed regulation will be identical to the regulation approved 
for LMP 102. We would hope this would help expedite the approval 
process.
    Intralytix will submit a food additive petition to FDA in the 
second quarter of 2007 for prevention of Salmonella in poultry and 
eggs.
    As a result of our research with Salmonella, we have developed a 
Salmonella vaccine that has proven to be very effective in reducing 
Salmonella colonization in poultry. When administered to newborn 
chickens, it reduces Salmonella colonization. In a study conducted by 
Perdue, Perdue reported that the Company's vaccine not only reduces 
colonization, but also improves the feed conversion ratio of the flock.
    During the development of our Salmonella vaccine, we discovered 
that vaccines created using the company's phage-based technology appear 
to have better immunogenicity than vaccines created with standard 
technology. We believe this is an important technology platform for 
future products, initially in the field of animal health, but 
eventually for human health.
    We currently have environmental products effective against 
Salmonella and Listeria. We have submitted our Listeria product to EPA 
for their approval. We believe the product has a market in food 
processing facilities.
    PhagoBioDerm is a novel bandage-like wound-healing preparation 
consisting of a biodegradable polymer impregnated with antibiotic and 
bacteriophages that was recently licensed for sale in the Republic of 
Georgia (one of the former Soviet Union republics). PhagoBioDerm is the 
trade name for a 0.2-mm-thick, perforated wound dressing prepared as 4 
x 5 cm films having a white/light yellow color. The films are 
impregnated with a mixture of lytic bacteriophages, an antibiotic, an 
analgesic, and sodium hydrocarbonate. The phage preparation is 
available commercially in the Republic of Georgia, and includes lytic 
bacteriophages active against Pseudomonas aeruginosa, Escherichia coli, 
Staphylococcus aureus, Streptococcus, and Proteus.

                               TECHNOLOGY

    Bacteriophages, the natural predators of bacteria, were one of the 
first specific antibacterial therapies to become available. In the 
earlier part of this century, bacteriophage therapy was commonplace. 
Eli Lilly & Co. listed several phage products until the early 1940's. 
Because of variability due to the then-incomplete understanding of 
phage biology, and because the immediate need of the medical community 
was for broad-spectrum antibacterials, bacteriophage therapy fell out 
of favor in the West. Eastern European and Soviet scientists, however, 
continued to develop bacteriophage technology alongside antibiotics, 
recognizing the inherent safety of bacteriophages and their 
complementarities to antibiotics.
    Bacteriophages are viruses that infect bacteria but cannot infect 
human or animal cells. At approximately 1/75,000th of an inch, 
bacteriophages are much smaller than their bacterial foes. The 
structure of a bacteriophage is similar to a lunar lander, with a 
hollow head packed with bacteriophage genes, a tunnel-like tail, and 
long spindly legs. Once the phage lands upon its prey, the core of its 
tail creates a channel communicating with the interior of the bacterial 
cell. The bacteriophage uses the channel to inject its own genes inside 
the bacterial prey. Once injected, the phage genes commandeer the host 
machinery and force it to construct new phages, as many as 200 within 
three-quarters of an hour. Eventually, the overproduction of phages 
bursts and destroys the bacterium, sending the newly minted phages 
forth to infect more bacteria. Several key differences render animal 
cells impervious to phage: (1) the receptors, or chemical signals to 
which phage initially bind are found on bacterial surfaces but not the 
surfaces of animal cells; (2) phage are adapted to inject genes through 
the cell wall of bacteria, not the completely different membranes of 
animal cells; and (3) phage can take over the cellular machinery of 
bacteria, but not the completely different machinery of animal cells.
    Resurgent interest in phage technology in the West is largely due 
to the emergence of antibiotic-resistant organisms. The lay press is 
filled with reports of so-called super bugs that are resistant to all 
known antibiotics, including those of last resort. In the United 
States, numerous hospitalized patients die each year because there is 
no effective antibiotic to treat their vancomycin-resistant 
Enterococci, or methicillin-resistant Staphylococci. Yet these same 
strains are sensitive to bacterio-
phages.
    Phage therapy has great appeal. Data from Eastern Europe and the 
former Soviet Union indicate that bacteriophages are not only 
effective, but they are safe as well. Bacteriophages trigger no 
allergic reaction in humans. In fact, phages are extremely common in 
the environment, are regularly consumed in foods, and are found as 
unintended contaminants in a variety of medications, including 
commercially available vaccines widely used in the United States. For 
example, there may be as many as 200,000,000 phages per milliliter of 
unpolluted water. There are virtually no reports of complications, 
environmental or clinical, associated with the use of therapeutic 
phages. Bacteriophages thus appear to be safe for many applications 
including food processing and sanitation as well as for direct 
therapeutic applications in humans.
    Commercial use of bacteriophages occurred in the West in the 1930's 
and early 1940's as previously mentioned. Phages were listed and sold 
as biological therapies by Eli Lilly, E.R. Squibb and Sons, and Swan-
Myers (Abbot Laboratories). These products were used in mixed 
infections of the soft tissues, infected surgical wounds of the abdomen 
and pelvis, and in nonspecific genito-urinary infections. The Pasteur 
Institute in Paris prepared and used phages on a case-by-case basis. In 
the East, the Ministry of Health of the former Soviet Union routinely 
licensed active phage preparations for use in humans for treatment of 
wound, enteric, and respiratory infections.
    Environmental effects are extremely unlikely since bacteriophages 
are ubiquitous. Commercial development involves selection of the 
appropriate naturally occurring phages that specifically, selectively, 
and efficiently kill the desired bacteria. No phages selected for use 
in food processing, sanitation, or therapy are capable of so-called 
lysogeny, where phages of undesirable classes insert into and alter 
bacterial DNA. Lytic phages, the type exclusively used by Intralytix, 
destroy their bacterial hosts without the possibility of transferring 
DNA. In order to ensure the phages used are lytic, Intralytix sequences 
all of our phages, and look for any undesirable genes. Since the 
bacteriophages cannot proliferate in the absence of their specific 
host, they disappear and become undetectable shortly after the last 
bacterium is killed. Bacteriophages thus represent a self-cleaning 
modality that fades away after doing its work.
    Bacteriophages were discovered by Twort and D`Herelle in the early 
part of this century. Because of their remarkable antimicrobial 
activity, phages were utilized for treating human infections almost 
immediately after their discovery, and they continued to be used 
therapeutically in the pre-antibiotic era worldwide. D`Herelle's 
commercial laboratory in Paris produced at least five phage 
preparations against various bacterial infections. In the United 
States, a large U.S. pharmaceutical company produced seven phage 
products for human use in the 1940s, including preparations targeted 
against staphylococci, streptococci, E. coli, and other bacterial 
pathogens. These preparations were used to treat various infections, 
including abscesses, suppurating wounds, vaginitis, acute and chronic 
infections of the upper respiratory tract, and mastoid infections. 
However, with the advent of antibiotics, interest in phage therapy 
waned in the United States and Western Europe. Antibiotics offered the 
broad bactericidal coverage necessary to treat infections prior to the 
establishment of a definitive diagnosis, whereas bacteriophages were 
exquisitely specific for individual bacterial strains or species. As a 
result, virtually no subsequent research was done on the potential 
therapeutic applications of phages in either humans or animals in the 
West. However, phages continued to be used therapeutically--together 
with, or instead of, antibiotics--in Eastern Europe and in the former 
Soviet Union. Several institutions in these countries were actively 
involved in therapeutic phage research and production, with activities 
centered at the Eliava Institute of Bacteriophage, Microbiology, and 
Virology of the Georgian Academy of Sciences, Tbilisi, Georgia,
    Intralytix is a pioneer U.S. company working on therapeutic 
bacteriophages. The company has made a significant progress in bringing 
phage technology to the cutting-edge biotech level by (a) identifying 
novel, commercially important applications for phage technology, (b) 
utilizing expertise from eastern European and former Soviet Union 
countries to adapt and improve state-of-the-art phage technology, (c) 
applying modern scientific approaches to better understand phage 
biology and phage-bacterial cell interactions, and (d) utilizing 
modern, state-of-the-art, biological processing technology. To this 
end, Intralytix has achieved a number of significant milestones, and it 
possesses significant expertise in the field that positions it well 
ahead of the competition. For example, Intralytix has:

    (i) optimized phage isolation and propagation techniques, which 
enabled the company to construct a large library of monophages against 
various multi-drug-resistant bacterial pathogens,
    (ii) developed pertinent animal models for evaluating phage safety 
and efficacy,
    (iii) delineated optimal phage delivery routes and dosage levels 
for environmental decontamination and clinical applications,
    (iv) optimized purification procedures for obtaining highly 
purified and concentrated phage preparations, and
    (v) determined optimal conditions for freeze-drying phages, which 
result in water-dispensable, easily transportable, and stable viable 
phage preparations.

    Phages are ``natural products,'' that are ubiquitous in the 
environment. For example, 1 ml of non-polluted water contains 
approximately 200,000,000 phages. Because of this, the environment is 
an excellent source for lytic phages; majority of Intralytix's phages, 
for example, were isolated from the waters of Baltimore Inner Harbor or 
Chesapeake Bay. Technologically, initial isolation of phages is a 
relatively straightforward procedure, and is an exercise often included 
in advanced college microbiology course laboratories. However, only a 
small fraction of all isolated phages will prove to have utility as a 
therapeutic agent. Identification of phages having broad lytic activity 
against a specific pathogen is a complex process, involving repeated 
isolation, propagation, and characterization of phages over a period of 
time. As noted above, Intralytix has proprietary technology for 
efficient phage isolation, identification, characterization, 
propagation, and purification. The company has used this technology to 
develop an extensive library of monophages targeted against various 
specific pathogens. This technology (and the resultant phage library) 
is one of the key elements in the ability of the company to rapidly 
move forward with commercialization of phage products.
    For production, phages are produced in fermenter lots by growing 
them on their host bacteria. Subsequent separation and purification of 
phages, and removal of adventitious material, involves know how 
technology proprietary to the company. At that point, as per an 
Intralytix-developed procedure, various phage preparations are 
constructed by mixing several separately grown and well-characterized 
lytic monophages, in order to: (a) achieve the desired, broad target 
activity of the phage preparation, (b) ensure that the preparation has 
stable lytic properties, and (c) minimize the development of resistance 
against the preparation. Phages and phage preparations can be stored as 
concentrated liquid preparations (stable for at least 6 months), or can 
be freeze-dried (viable indefinitely long).
    In studies conducted by Intralytix, the Company's phages were 
highly effective in decontamination of environmental surfaces and 
electronic equipment. In studies conducted in collaboration with 
investigators at the Agricultural Research Service, USDA, aerosolized 
phage preparations have also been highly effective in reducing 
pathogens on various fruits and vegetables by several logs (from 100 to 
over 1,000 fold). Thus, phages are proven to be highly effective in 
these settings. However, appropriate technology for phage delivery and 
optimal application methodologies must be developed for phage treatment 
to be maximally effective. Intralytix has developed such technology.

                                LMP 102

Identity and Formulation
    LMP 102 is a phage preparation consisting of a mixture of equal 
proportions of six individually purified phage, each of which is 
specifically effective against genetically diverse Listeria 
monocytogenes strain populations. It is possible to optimize the 
effectiveness of the preparation by customizing for differences in L. 
monocytogenes strains and serotypes that predominate in different 
geographic regions of the country or that may be associated with 
particular food type facilities. Six different phages will always be 
used to provide robustness.
    Bacteriophages have been isolated from drinking water and from a 
wide range of food products, including ground beef, pork sausage, 
chicken, farmed freshwater fish, common carp and marine fish, oil 
sardine, raw skim milk, and cheese.
    LMP-102 is all natural product that contains six bacteriophages 
isolated from the environment. The phages have not been altered or 
manipulated in any way. The preparation is specifically targeted 
against L. monocytogenes--one of the deadliest foodborne bacteria that 
kill approximately 25 percent of the people infected. The product does 
not otherwise alter the general composition of the foods, and it 
triggers no adverse organoleptic changes (i.e., it does not alter 
taste, odor or color of treated foods). The product has no effect on 
food shelf life (i.e., it does not extend the shelf life of treated 
foods).
    The product is all natural, and no media of animal origin has been 
used during its preparation. In addition, no known, potentially 
allergenic substances (wheat, milk, soy, etc.) have been added to/mixed 
with the product.
    The phage component of LMP-102TM is roughly estimated to be 0.1 ppm 
by weight and the remainder is phosphate-buffered saline containing up 
to 125 ppm residual organics from the growth medium and biomass.
    The LMP-102TM article of commerce is a liquid made up of six 
monophages that individually have a lytic titer of 9.0  0.5 log10 
plaque-forming units (PFU) per ml.

LMP-102TM Proposed Use Levels
    It is proposed that LMP-102TM be allowed for use as an 
antimicrobial processing aid in the production of ready-to-eat (RTE) 
meat and poultry products. LMP-102TM article of commerce is applied to 
the surface of the RTE food articles just prior to packaging. For most 
RTE food articles, this will require application of LMP-102TM at a rate 
of approximately 1 ml per 500 cm\2\ (2 ml/cm\2\) of RTE food article 
surface area.

Directions for Use
  Dispensing
    Automated dispensing equipment will be used in most applications of 
LMP-102TM. The dispensing equipment will be microprocessor controlled 
and will provide for accurate delivery of the phage solution to the 
specific application points. Dispensing equipment and commercial 
product package will have an integral ``lock and key'' connection 
device to prevent inadvertent dispensing of improper compositions. 
Dispensing system and package design will provide for near-complete 
evacuation of commercial product package to prevent excess discharge of 
active material to environment and waste stream.
    Dispensing system will have an integrated clean-in-place (CIP) 
system to provide daily, or as required, cleaning and sanitizing of the 
dispensing system.

  Application
    The application mechanics may be different for each type of RTE 
food article treated with LMP-102TM solution. In all applications, the 
phage solution will be spray applied onto the RTE food article surface. 
Low volume (low flow rate), low-pressure spray nozzles will be utilized 
to accurately dose the phages to all surfaces of the RTE food article. 
In some cases air-assisted spray nozzles may be employed to provide 
additional motive force to the low volume spray.

Description of Intended Technical Efect
    LMP-102TM is intended to produce significant reduction of L. 
monocytogenes contamination vs. a water control when applied as 
directed to ready-to-eat (RTE) food products. LMP-102TM is further 
intended to produce significant reduction of L. monocytogenes 
contamination vs. an untreated control when applied as directed to RTE 
food products. In general, the reduction of L. monocytogenes 
contamination is better than 90 percent and often better than 99 
percent.''

Categories of Ready-to-Eat Food Products
    LMP-102TM is intended to reduce L. monocytogenes contamination on a 
broad spectrum of RTE food products. RTE food products are products 
designed and labeled for consumption by the consumer without cooking at 
temperatures sufficient to kill any microbial contaminants that might 
be present. The following table represents categories of RTE meat and 
poultry products along with representative items in each category. The 
rationale behind the efficacy studies described in this section is that 
successful production of the intended technical effect on a foodstuff 
in a given category is indicative of efficacy among members of that 
category in general.

                Categories of ready-to-eat food products
------------------------------------------------------------------------
                                     Food category          Example
------------------------------------------------------------------------
1...............................  Cooked cured        Beef frankfurters
                                   comminuted
                                   products, red
                                   meat.
2...............................  Sliced cooked       Corned beef
                                   cured whole
                                   muscle cuts, red
                                   meat.
3...............................  Injected whole      Flavored roast
                                   cooked muscle       beef, uncured,
                                   cuts, red meat.     water added
4...............................  Sliced cooked       Roast beef,
                                   whole muscle        minimally
                                   cuts, uninjected,   processed
                                   red meat.
5...............................  Cooked cured        Turkey
                                   comminuted          frankfurters
                                   products, poultry.
6...............................  Sliced cooked       Turkey pastrami
                                   cured whole
                                   muscle cuts,
                                   poultry.
7...............................  Injected whole      Roast turkey skin,
                                   cooked muscle       uncured
                                   cuts, poultry.
8...............................  Sliced cooked       Roast turkey,
                                   whole muscle        minimally
                                   cuts, poultry.      processed
9...............................  Sliced cooked       Sliced bologna,
                                   comminuted meat     beef & pork
                                   products.
10..............................  Sliced cooked       Sliced bologna,
                                   comminuted          turkey
                                   poultry products.
11..............................  Uncured fermented   Lebanon bologna
                                   comminuted red
                                   meat products.
12..............................  Uncured fermented   Uncured turkey
                                   comminuted          salami
                                   poultry.
------------------------------------------------------------------------

Summary of Efficacy Data
  Description of Test System
    Efficacy studies were carried out under good laboratory practices 
(GLP). Twenty-seven samples of each of the 12 RTE products were 
inoculated on one surface with approximately 2 x 10\3\ CFU per cm\2\ of 
a 1:1:1 mixture of three L. monocytogenes strains, L. monocytogenes 
ATCC 19115 (serogroup 4b), L. monocytogenes Lm 68 (serogroup 1/2b), and 
L. monocytogenes Lm 82 (serogroup 1/2a). Samples were incubated for 20 
 1 min at room temperature to allow for bacterial attachment. Nine 
samples of each inoculated RTE product were treated with LMP-102TM. 
Nine samples of each inoculated RTE product were treated with a water 
control. The LMP-102TM and water control were applied to RTE product 
samples in a spray, using an airbrush adjusted to deliver 100  20 ml 
per 4 seconds. All RTE product samples except frankfurters were sprayed 
for four seconds. Frankfurters were sprayed for a time period dependent 
upon their surface areas.
    Following treatment, samples were vacuum packed and stored at 5  
2 C for 24  4 h, 72  4 h, or 168  4 h. Samples were then analyzed 
for populations of L. monocytogenes. Phosphate buffered dilution water 
(PBDW, 100 ml) was added to the packages containing the RTE product 
samples, which were subsequently stomached. The resulting stomachates 
were serially diluted in PBDW and plated on MOX. Petri plates were 
incubated at 37  2 C for 48  4 h. The GLP Efficacy Study Report is 
included in Appendix F01.
  Summary of Results
    Compared with 250 ppm synthetic hard water only, LMP-102TM applied 
at a rate of approximately 1 ml per 500 cm\2\ (2 ml/cm\2\), reduced 
populations of L. monocytogenes by 1.0-2.75 logs on all RTE products 
evaluated at 24  4, 72  4, and 168  4 hours of storage at 5  2 C. 
The reduction was statistically significant (P < 0.05). One exception 
was Lebanon bologna. Because Lebanon bologna exhibited intrinsic 
bactericidal activity against L. monocytogenes, recoverable populations 
in both treated and control samples were not obtainable in several 
instances, which resulted in a lack of variance in data. Thus, while 
application of LMP-102 appeared to reduce the levels of L. 
monocytogenes on Lebanon Bologna, statistical analysis was not possible 
in samples stored for 72  4 and 168  4 hours.

 
------------------------------------------------------------------------
                                    Log10 reduction LMP-102TM treatment
                                             vs. water control
           RTE product            --------------------------------------
                                       24 h         72 h         68 h
------------------------------------------------------------------------
Beef frankfurters................         1.91         1.45         1.25
Sliced ham.......................         2.07         2.16         1.16
Flavored roast beef, uncured,             1.51         1.79         2.00
 water added.....................
Roast beef, minimally processed..         1.62         1.79         1.35
Turkey frankfurters..............         1.71         1.18         1.28
Turkey pastrami..................         1.48         1.88         1.83
Roast turkey skin, uncured.......         2.11         2.53         2.61
Roast turkey, minimally processed         1.49         1.36         1.33
Sliced bologna, beef & pork......         2.34         2.69         2.45
Sliced bologna, turkey...........         2.67         2.57         2.75
Lebanon bologna..................         0.62         1.00         1.00
Uncured turkey salami............         1.99         1.97         1.90
------------------------------------------------------------------------

Safety of LMP-102TM Components
  Safety of the Phages--Background Exposure to Phages and Phage 
        Ubiquity
    The safety and ubiquity of bacteriophages have been well 
established. The pertinent safety data on bacteriophages is briefly 
reviewed below. The published literature on phages, and other 
information developed by Intralytix, shows that:
     Bacteriophages are arguably the most ubiquitous organisms 
on earth. For example, one milliliter of non-polluted stream water has 
been reported Bergh et al., 1989 to contain approximately 2 x 10\8\ PFU 
of phages/ml (Appendix H01), and the total number of phages on this 
planet has been estimated to be in the range of 
10\30\-10\32\. This abundance of phages in the environment, and the 
continuous exposure of humans to them, explains the extremely good 
tolerance of the human organism to phages.
     Phages have been used therapeutically in humans for more 
than 80 years, without any recorded illness or death. During the long 
history of using phages as therapeutic agents in Eastern Europe and the 
former Soviet Union (and, before the antibiotic era, in the United 
States, France, Australia, and other countries), phages have been 
administered to humans (i) orally, in tablet or liquid formulations, 
(ii) rectally, (iii) locally (skin, eye, ear, nasal mucosa, etc.), in 
tampons, rinses and creams, (iv) as aerosols or intrapleural 
injections, and (v) intravenously, albeit to a lesser extent than (i) 
to (iv)--and there have been virtually no reports of serious 
complications associated with their use.
     Phages have also been administered to humans for non-
therapeutic purposes without any recorded illness or death. To give 
just a few examples, phage preparations have been used extensively to 
monitor humoral immune function in humans in the United States in the 
1970s-1990s, including in patients with Down's syndrome, the Wiskott-
Aldrich syndrome and immunodeficient patients (Lopez et al., 1975; Ochs 
et al., 1982; Ochs et al., 1992; Ochs et al., 1993a). In some of the 
studies (including FDA-performed studies), the purified phages were 
injected intravenously into HIV-infected patients or other 
immunodeficient individuals without any apparent side effects (Fogelman 
et al., 2000; Ochs et al., 1971; Ochs et al., 1993b).
     The biology of phages has been exhaustively studied. These 
studies have clearly shown that phages are obligate intracellular 
parasites of bacteria and are not infectious in humans or other 
mammals.
     Phages have been found in commercial sera and in FDA-
approved vaccines commercially available in the United States (Merril 
et al., 1972; Milch and Fornosi, 1975; Moody et al., 1975).
     Bacteriophages are common commensals of the human gut, and 
they are likely to play an important role in regulating the diversity 
and population structure of various bacteria in human GI tracts. Phages 
capable of infecting E. coli, Bacteroides fragilis and various 
Salmonella serotypes have been isolated from human fecal specimens in 
concentrations as high as 10\5\ PFU/100 g of feces (Calci et al., 1998; 
Furuse et al., 1983; Armon et al., 1997). The recent data based on 
metagenomic analyses (using partial shotgun sequencing) of an 
uncultured viral community from human feces suggested that 
bacteriophages are the second most abundant category after bacteria in 
the uncultured fecal library (Breitbart et al., 2003).
     No adverse immunologic or allergic sequelae have ever been 
reported because of human or animal exposure to phages.

    The Chairman. Thank you very much. Dr. Whitaker, I'm 
impressed that there are six million bags of fresh salad a day 
consumed in the United States. I had no idea.
    What do you think was the estimated cost to the spinach 
industry of this industry-wide recall, and do you have any 
suggestions for limiting the impact to the industry and 
reducing that number in a similar situation?
    Dr. Whitaker. I think the quantification of that is still 
ongoing but I understand--the number I've heard is about $100 
million, across the whole industry.
    The Chairman. OK. Do you have any suggestions for ways to 
limit the impact on an industry? We run into this with beef, 
too, when something happens anywhere in the country, people 
stop eating beef for a while and there are some pretty 
significant costs to our ranchers. So one of the things they've 
asked for is some additional confirmation before it becomes 
widely broadcast, but yet we want to make sure that we're 
notifying people so they have as little problem as possible.
    Dr. Whitaker. Yes, Mr. Chairman, it's paramount that when 
something like this happens that public safety be protected. 
Off the top of my mind, the thing that would help in the future 
is to be able to narrow it down sooner. We just heard officials 
talk about having it narrowed down to one process or 1 day 
within 2 weeks and yet, spinach itself was not--did not enter 
the marketplace again for another several weeks after that and 
even today, we still suffer from it because it was not 
broadcast clearly that this was limited to a single processor, 
single set of farms, on a single day. So I think, in that 
fashion, a little bit more timely notification probably would 
have helped us some. But when you have an outbreak like this, I 
mean, certainly the balance has to shift toward protecting the 
public health.
    The Chairman. Thank you. Ms. Crawford, I'm interested in 
these tags because we've been, of course, talking about the 
country of origin labeling for cattle for some time and we've 
run into some real cost difficulties on that. So now we're 
talking about tagging each bag of produce. What do these 
labels, these RFIDs cost?
    Ms. Crawford. Well, actually in today's testimony, I didn't 
talk about tagging the individual units that you sell because 
the cost is still a little bit high for item level tagging and 
the read rates aren't really there for item level tagging. But 
for case level, I talked about tagging each case. So that's not 
nearly as impactful as tagging each bag and to be able to track 
product through the supply chain, just to know where it is, 
really at the case level, gives you a lot greater visibility 
than what you have today. So once that case is open and placed 
on the grocery shelf, if there is a recall, then the grocery 
personnel can go and look for that product on the grocery shelf 
but to be able to find all that product everywhere in the 
supply chain, if it was just on the cases, then to me, that's 
something that--the technology is more readily available for, 
ready to react in that environment, the read rates are better 
at that level than they are at the each level. Of course, 
everyone in the industry wants to get to where RFID tags are at 
the each level. But the price has to come down and the 
performance has to go up and significant changes are made every 
day in both of those areas. So you can tag a case for--it all 
depends on the quantity of tags that you're buying, but you 
could probably tag a case for 20 cents. That's pretty 
inexpensive for public safety.
    The Chairman. Is there a distance range to the 
transmission?
    Ms. Crawford. Yes, there is. Usually from 3 to 15 feet is 
what you're going to get from the type of tags that I'm talking 
about using.
    The Chairman. Another concern I'm sure that we'll run into 
is, is the radio transmission dangerous to people or other 
products or technology? Will it affect people's health?
    Ms. Crawford. No. It's not dangerous. The paths of RFID tag 
is not dangerous to people and actually it's funny. Someone 
asked me that question recently and they said--it isn't funny 
though--``when people ask you that question, they're usually on 
their cell phone with that right up against their head.'' So 
they should be a little more concerned about that than about 
the frequency from the radio frequency ID tags.
    The Chairman. Thank you. Mr. Palmer, how does your product 
differ from the time stamp that is on a package? The purchase 
by or sell no later than stamp?
    Mr. Palmer. Well, currently the systems we sell are 
primarily in operations within restaurants and kitchens. So we 
would then help the operations in the back of a kitchen or 
restaurant properly rotate their food within the shelf life 
that is required. We do that through a dissolving label that 
would be put on a food container that would track the time it 
was prepared and the time it needs to be expired, meaning the 
shelf life of the food. If you wanted more extensive tracking 
of that within the food service operations, you could go to 
Timestrip, which tracks time and temperature.
    The Chairman. Do they change color as the time goes by?
    Mr. Palmer. On the Timestrip technology, yes it does. It 
turns red and it actually has a duration. It can be as low as 
30 minutes and as long as 5 days. A red line will appear and 
it's capillary infusion technology that basically is a very 
eloquent technology but very simple at the same time because 
it's a universal language that basically says either this 
product is good to be used or it will be discarded. If the red 
line is all the way across the tag, it means to discard.
    The Chairman. I'm also impressed by labels that will 
dissolve in 30 seconds. I had never thought about the need for 
freezable labels. I guess a lot of us don't work with that sort 
of thing.
    As a small businessman, in developing your technology, did 
you have an opportunity to work with the Small Business 
Innovative Research grants, SBIR?
    Mr. Palmer. We actually did work with Timestrip and the 
State of Ohio in doing that. Unfortunately, we weren't 
successful.
    The Chairman. OK. Can you tell me a little bit more about 
how your technologies and products tie in with the hazard 
analysis and critical control points or HACCP procedures?
    Mr. Palmer. Certainly. Since HACCP, OSHA and FDA 
regulations are in place, all driven by the need to prevent 
food contamination and foodborne illness and unsanitary 
conditions, it appears, we believe, providing tools, training 
and technologies to all food service operations is the next 
step in implementing food safety and safeguarding consumers. It 
is also imperative that operators understand the cost of the 
tools and the training may be an initial expense but will 
ultimately translate into a huge savings of time and money, 
given the cost of healthcare, medical treatment and lost time, 
not to mention loss of business due to lawsuits and safety 
violations.
    The Chairman. Thank you. Mr. Vazzana, I'm impressed with 
phages but can you kind of give me a layman's explanation of 
what they are?
    Mr. Vazzana. They are a virus. They are the most ubiquitous 
organism on the planet today. They are everywhere. They are, as 
I said, in one milliliter, 20 drops of water, there are 200 
million phages. And the only thing they do in this world, is 
they attack specific bacteria. So you find a phage that is 
effective against E. coli, it will go in and kill E. coli 
O157:H7 but it will not affect the phages or the bacteria 
around it. They are harmless, to plant cells, to human beings 
and to animals. They have been here and people have co-existed 
with this organism for billions of years.
    The Chairman. Will bacteria such as Listeria develop a 
resistance to the phage?
    Mr. Vazzana. In theory, we believe they will. And over the 
billions of years, bacteria have evolved and the phages have 
evolved with them. So as the bacteria evolve, there will be 
phages that we can find that we can use on the new bacteria. We 
also make a product with a cocktail. So we have like six 
different phages in LMP 102. So as a bacteria evolves, evolves 
into the next phage. So we believe that bacteria will find 
resistance to everything that exists but we believe that there 
always will be a new phage that we can put in the product.
    The Chairman. I just learned today that chlorine is not a 
kill step, when it's used in washing things. You indicate that 
you'd prefer to receive FDA approval under the Food Contact 
Substance Notification process?
    Mr. Vazzana. We believe--and I'm not an expert on 
government regulations and our attorneys are. I would love to 
have the opportunity to provide a paper on using that program 
and they know a lot more about it. But the problem is that it 
takes so long. Now the first product took 4 years and I'm the 
first to tell you that Intralytix was a major cause of a lot of 
that delay. We didn't know what FDA wanted. It was a new 
product or a new technology for FDA so I think they had to find 
out what they really wanted and that took a lot of time. But 
the bottom line is that after the day came when the technical 
review was done and it was approved, it was 18 months from that 
date before we finally got approval of the regulation because 
of all of the things that they have to do. So we want them to 
look at the technology and we are willing to follow a 
regulation very much like the one that they have already 
approved but we believe that we need to get this technology out 
into the public and into the market so that we can play a part 
in improving food safety.
    The Chairman. Thank you. I greatly exceeded my time and I 
apologize to my colleague.
    Senator Burr. Mr. Chairman, that's quite all right. It's 
getting late so I'm going to be brief and with the Chairman's 
OK, I'd ask unanimous consent that we be allowed to send 
additional questions to them as they arise.
    The Chairman. Absolutely.
    Senator Burr. And I'd also like to follow up with Mr. 
Vazzana--since I notice you're in Baltimore.
    Mr. Vazzana. Yes, sir.
    Senator Burr. I would love to invite you back to meet with 
my subcommittee staff to talk more in depth about phages.
    Mr. Vazzana. I would love to have that opportunity.
    Senator Burr. And we would be more than happy to talk about 
FDA at that time, if that's okay with the Chairman and 
certainly the full committee staff is welcome to attend.
    Mr. Vazzana. What time tomorrow do you want to do that?
    Senator Burr. I'll make sure the appropriate introductions 
are made before we leave and I only hope as you go through this 
process with FDA, you can look at the current process and 
realize that 4 years at the FDA is like lightening speed. So 
I'm curious as to the process you've gone through and we'll 
certainly try to help guide you in any way we can. But we'd 
also like to pick your brain on phages and how we might explore 
those in a countermeasure-way as it relates to some natural and 
intentional threats that we are faced with in this country.
    Mr. Palmer and Ms. Crawford, thank you very much for the 
update on your technologies. Food dates are important. 
Budweiser proved that to me with the born on date on beer. 
People do respond to freshness and I think that will become 
something that even my wife should use.
    I want to turn to Dr. Whitaker, if I can, because I'm still 
trying to clarify something from the last panel. You made the 
statement that this contamination is from four farms, one 
processor, same day product. That is pretty consistent with 
what Dr. Reilly said, four farms, one field, one processor--I'm 
not sure if he said same day. I'm still a little unsettled as 
to why CDC and FDA didn't spell out four farms, one processor, 
1 day but I can assure you in followup questions, we will find 
the answer to that. Given the way you presented it, that leads 
one to only believe that it could happen in the wash. Given 
what Dr. Reilly suggested, which was one of four farms, one 
field, one processor, one could conclude from that, that it 
either happened in the wash process or there was a 
contamination in one field that in the processing of that one 
field's worth of spinach, contaminated spinach from potentially 
three other farms and this all happened on the same day. Can 
you help distinguish anything for me or have I pretty much got 
it right there?
    Dr. Whitaker. I think you've pretty much got it. I think 
the confusion may be is that the communication that we've had 
from FDA is that they had narrowed it down from nine farms to 
four farms and that's pretty much where it stood and I think we 
heard today that they have found evidence of E. coli O157:H7 on 
all four farms. However, only one of those farms had the strain 
that was then subsequently found to be the strain that caused 
illness. So that may be where the confusion sits.
    Senator Burr. And let me say, as empathetic as I am to the 
loss that you've had, the extent of where we can go, I think, 
is very limited. I say that because today, it's spinach and the 
products that you and other growers have. It's the inability to 
get Japan to take chicken parts because all of a sudden, there 
is a problem and chicken parts go bad on the ocean after a 
certain period of time or the beef that's in transit when we 
have an outbreak here and countries refuse to take our beef and 
the beef goes bad and processors and distributors and 
manufacturers eat it. So even though we're empathetic, I'm not 
here to optimistically tell you that even though you asked, 
that that is going to be one of those answers that you really 
like. By the same token, I hope you understand that today as we 
sit here, I think in retrospect, the FDA could have in a much 
clearer and quicker way, made the pronouncement that all 
spinach was safe to eat. I wanted to hear them say it today. 
That's why I asked them. By the same token, it should alarm you 
and it does alarm me that we still can't pinpoint what 
happened. So I can understand the reluctance over some period 
of time. We tried very desperately today to better understand 
what the appropriate period of time for this incident, for the 
next incident and for any incident in the future, should be. At 
least we've established some parameters now and my hope is that 
the FDA will look back on their process and will learn the 
downstream effects and try to mitigate that as much as they can 
in the future. But it does concern me today that we still can't 
put our finger on exactly where the contamination took place so 
that there can be some attempt at remediating a problem that 
exists. That doesn't give me a great comfort level that we 
might not go through a similar experience that has similar 
time-
lines and similar loss. So I hope and encourage the industry to 
continue to work with these agencies to try to figure out how 
to No. 1, eliminate the risk in the future, if that is 
possible. I'm not convinced it is. And No. 2, to refine their 
processes and how that dovetails into what you do so that we 
can shorten that timeframe to as short a period as we can.
    With that, I thank the Chairman.
    The Chairman. Thank you very much. I want to thank all of 
today's witnesses for their excellent testimony. I want to 
thank Senator Burr for his interest and attendance and also 
Senator Isakson. We will be emphasizing this hearing to all of 
our colleagues so that they will take a look at the testimony 
that you've provided. One of the benefits of a hearing like 
this is we learn a lot of things that we never knew about. 
Sometimes they are things that we wish we didn't know about. 
But mostly, they are very beneficial to helping us to 
understand that everybody's job is pretty tough and that there 
are a lot of things that we don't know about, a lot of things, 
and when we get some experts like you to help to enlighten us, 
it's a tremendous advantage. I know we don't have any further 
questions at this time, however all members of the committee 
have the right to submit questions for the record and I hope 
that you'll be willing to answer those as promptly as you can. 
We will keep the record open for 10 days so that questions can 
come from my colleagues. I do have a statement from Senator 
Durbin and I'd ask unanimous consent to make that a part of the 
record of the hearing as well.
    [The prepared statement of Senator Durbin follows:]

               Prepared Statement of Senator Dick Durbin

    Years ago, a friend from Chicago went out and bought 
hamburger meat at a local grocery store. She took it home, 
cooked it, and gave it to her 5-year-old boy. That poor boy was 
exposed to E. coli and died a few days later, a gruesome, 
horrible death.
    In 1992, four children died and 700 people were sickened by 
an E. coli outbreak that was traced to hamburgers served at 
Jack in the Box restaurants. That outbreak proved to be a 
pivotal moment in the history of the beef industry. The Federal 
Government revamped the meat inspection program which has led a 
decline in the number of illnesses from beef since 2000.
    The E. coli outbreak from packaged spinach that occurred 
just a few months ago may prove to be the critical event for 
the produce industry as the Jack in the Box outbreak was for 
the meat industry. Three people have died and 199 have been 
sickened in 26 States due to E. coli that was traced back to 
packaged spinach.
    The Centers for Disease Control and Prevention estimate 
that as many as 76 million people suffer from food poisoning 
each year. Of those individuals, approximately 325,000 will be 
hospitalized and more than 5,000 will die. Children and the 
elderly are especially vulnerable to foodborne pathogens. 
Despite these statistics, our food supply is still the safest 
in the world; however, there are widening gaps in our food 
safety system due to the fact that food safety oversight has 
evolved over time and is spread across several agencies.
    At a time when consumers are being urged to eat more fresh 
vegetables, it is imperative that the Government, consumer 
groups and those with an interest in the produce industry 
develop strong science-based standards that will minimize the 
risk of illness from fresh produce.
    The produce industry has undergone many changes over the 
years. In the past, it was likely that produce that ended up in 
a local grocery store came from a farm not too far from the 
retailer. Fast forward to today--produce grown on a single farm 
in one State could end up on dinner tables in many States 
across the country. We are trying to use a 1950s food safety 
model to oversee a 21st Century food distribution system. 
That's like asking a propeller plane to keep up with an F-18.
    As the number of foods imported from outside the United 
States continues to increase so do concerns that terrorists 
could easily attack our food supply and distribute a harmful 
product widely. It is more important now then ever to reinforce 
any potential weak spots in our food safety system.
    One of the first changes that should be made is to give the 
agencies charged with overseeing food safety the ability to 
issue mandatory recalls. Consumers depend on the Federal 
Government to ensure that their food is safe for them and their 
families. The inability of the Government to issue a mandatory 
recall would be like telling public health officials that they 
can ask--but not require--a restaurant to temporarily close if 
the restaurant is found to have a rodent infestation. It defies 
common sense. Mandatory recall authority should be a tool in 
the FDA's arsenal.
    Next, we must implement a regular inspection program for 
domestic food facilities, with inspection frequency based on 
risk. One stark example of the inconsistency in our food safety 
system is the lack of standardization for food inspections--
processed food facilities may be inspected once every 5 or 6 
years by the FDA, while meat and poultry operations are 
inspected daily by USDA. This is unacceptable. Must we wait for 
an even deadlier E. coli outbreak to occur before we address 
the most obvious and serious weaknesses in our food safety 
system?
    Another change that is needed is to require food producers 
to code their products so that those products can be traced 
quickly in the event of a foodborne illness outbreak in order 
to minimize the health impact of an event like the spinach 
contamination. In that outbreak, it took several weeks from the 
time the first illness was reported to the day the FDA issued 
its general warning for consumers to avoid eating packaged 
spinach.
    Finally, we should consider a complete overhaul of the 
piecemeal approach our country has taken to protect the public 
from foodborne illnesses. We need to create a single food 
safety agency. Factors such as emerging pathogens, an aging 
population at high risk for foodborne illnesses, an increasing 
volume of food imports, and people eating more frequently 
outside their homes, underscore the need for change. The 
Government Accountability Office has been calling for a single 
food safety agency for more than 25 years. In a 1998 study, the 
National Academy of Sciences concluded that,

          ``A model food safety system should have a unified mission 
        and a single official who is responsible for food safety at the 
        Federal level and who has the authority and the resources to 
        implement science-based policy in all Federal activities 
        related to food safety.''

    We need to change, to shed the old bureaucratic shackles 
that have tied us to the overlapping and inefficient ad hoc 
food safety system of the past and create a system fit for the 
21st Century.
    The Chairman. I think a lot of the questions that he has 
asked have been addressed in this hearing and that will be 
helpful as well. So again, thank you for your participation 
today and the hearing is now adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                   Prepared Statement of Dan Verdelli

    We at Verdelli Farms sincerely appreciate the opportunity to 
address this committee concerning the recent outbreak of E. coli 
O157:H7 and the subsequent effect it has had on the fresh cut industry.
    Verdelli Farms is the premier East Coast regional processor of 
fresh cut vegetables. The company roots go back to 1921 when Ciraco 
Verdelli and his family settled in the Hershey, PA area and worked on a 
vegetable farm there. The family purchased the farm in 1943 and 
Ciraco's sons Albert, Bruno, and Caesar pioneered the packaging of 
fresh vegetables for sale in grocery stores. The company was 
incorporated in 1952 and produced packaged vegetables from their plant 
in Hummelstown, PA. In 1978 the third generation took over the daily 
operations and plant management. The company moved vegetable production 
to a new facility in Harrisburg, built to USDA Dairy regulations in 
1993. With a fourth generation of the Verdelli family presently 
involved in the company, Verdelli Farms continues its commitment to its 
customers and the fresh cut industry to provide the safest, highest 
quality products possible.
    The safety of our products has always been our No. 1 priority. We 
employ a full time Quality Assurance staff of food scientists and other 
professionals and technicians who are responsible for maintaining our 
food safety programs. We have a documented HACCP (Hazard Analysis 
Critical Control Points) plan and numerous prerequisite programs in 
place such as a Pest Control Program, Good Manufacturing Practices in 
production, and a Sanitation Program. One entire shift is devoted to 
sanitation to assure that our facility is cleaned and sanitized daily. 
The QA staff constantly monitors these programs to assure that 
everything is being done in the proper manner to maintain the maximum 
safety of all of our products. Third party audits are conducted 
frequently with very favorable results.
    You are of course aware of the outbreak of E. coli O157:H7 that 
occurred in mid-September involving fresh spinach. A recommendation was 
issued by the FDA for all fresh spinach to be removed from store 
shelves and for consumers to refrain from consuming any fresh spinach. 
We, at Verdelli Farms, have the utmost respect for the FDA. With the 
wide variety of foods available to the American public from domestic 
and international sources, monitoring the safety of our food supply is 
truly a daunting task. However, that being said, we question some 
aspects of how this particular outbreak was handled.
    The spinach implicated in this outbreak was baby flat leaf spinach 
from California. Much of the spinach that Verdelli Farms packs is curly 
leaf spinach. This curly leaf spinach is not grown in the Salinas 
Valley of California where the outbreak originated. At the time of the 
outbreak we were packing spinach from Colorado and have since moved 
into East Coast grown spinach. Throughout the year we also pack spinach 
from Texas and Arizona. The fact that the recommendation from the FDA 
did not differentiate spinach types resulted in a devastating effect on 
the spinach industry. A great deal of harm was done to large and small 
processors and growers throughout the country and it continues to 
affect all those involved. Verdelli Farms was forced to layoff close to 
70 employees due to loss of spinach sales. Although the production is 
slowly returning it is a slow process and we have as yet been unable to 
call back any of those employees. This scenario is being repeated 
across the country by many processors and growers. An additional 
difficulty we are faced with is the inability to acquire compensation 
for the losses incurred by this situation. Because the action by the 
FDA was a recommendation rather than an official recall we have been 
unable to receive any insurance coverage even though clearly the effect 
on the company was the same.
    Some of this economic loss may have been avoided if the 
recommendation by the FDA had been more specific and had not included 
the curly leaf type of spinach. In addition to the economic effects 
discussed above, many American consumers are now avoiding a product 
that is one of the healthiest, most nutritious vegetables available. 
And it is not only spinach sales that have been impacted. We have seen 
a decrease in sales of other items, also. Some consumers have developed 
a general mistrust of packaged fresh cut salads and vegetables. If this 
results in an overall decrease in vegetable consumption it is clearly 
detrimental to the overall health of the American public.
    Verdelli Farms appreciates this opportunity to voice our opinions 
concerning the recent E. coli outbreak in fresh spinach. Again, we 
respect and appreciate the work of the FDA in safeguarding the health 
and well-being of the American public. We have simply tried to give our 
viewpoint on the handling of the crisis and give a general overview of 
the repercussions of the FDA recommendations from our perspective. 
Thank you again for the opportunity to address our concerns.

       Response to Questions of Senator Enzi and Senator Kennedy 
                      by Robert E. Brackett, Ph.D.

                       QUESTIONS OF SENATOR ENZI

    Question 1. What can consumers do to prevent bacterial 
contamination in fresh produce? For example, will washing produce prior 
to consumption by the consumer remove E. coli and Salmonella?
    Answer 1. FDA continues to emphasize consumer advice to reduce the 
risk of foodborne illness from fresh produce. FDA's advice to consumers 
is always to wash fresh, intact fruits and vegetables before 
consumption. While washing may not remove all bacteria, it is an 
important method to use to reduce the amount of bacteria that may be 
present.
    Consumer safe handling practices begin at the grocery market and 
extend to include storage at home, food preparation, and kitchen 
sanitation. We have provided a number of safe handling practices that 
consumers can follow to protect themselves from illness associated with 
raw produce. These are available at http://www.cfsan.fda.gov/dms/
prodsafe.html. We mention a few of the recommendations below.
    Consumers should only purchase produce that is not bruised or 
damaged. When selecting fresh-cut produce, such as a half watermelon or 
bagged mixed salad greens, consumers should choose only those items 
that are refrigerated or surrounded by ice. At purchase, fresh fruits 
and vegetables should be bagged separately from meat, poultry and 
seafood products when packing them to take home from the market.
    At home, all produce that is purchased pre-cut or peeled should be 
refrigerated to 40+ F or below to maintain both quality and safety. 
When preparing fresh produce, we recommend consumers cut away any 
damaged or bruised areas and thoroughly wash the produce. Drying 
produce with a clean cloth towel or paper towel may further reduce 
bacteria that may be present.
    We recommend that consumers keep fruits and vegetables that will be 
eaten raw separate from other foods such as raw meat, poultry, or 
seafood and also keep them separate from the kitchen utensils used for 
those products.

    Question 2. Are mandatory Federal and/or State food safety 
guidelines for farmers and processors needed to restore public 
confidence in fresh produce?
    Answer 2. FDA is committed to improving the safety of fresh 
produce. FDA plans to hold a public meeting in early 2007 to address 
the issue of foodborne illness linked to leafy greens. We will also be 
examining whether improvements in the following four areas could help 
prevent or contain future outbreaks: (1) strategies to prevent 
contamination; (2) ways to minimize the health impact after an 
occurrence; (3) ways to improve communication; and (4) specific 
research. As we evaluate ways in which we can prevent or contain future 
outbreaks, we will consider whether additional guidance and/or 
regulations are necessary.

    Question 3. There are a number of Federal agencies involved in food 
safety. Critics charge that overlapping jurisdictions and duplication 
of effort waste taxpayers' money and result in a fragmented system that 
prevents an effective focus of resources and advocate for a single 
agency charged with ensuring the safety of our food supply. Others 
argue that, by working cooperatively and through formal understandings 
among the agencies, Federal agencies now, for the most part, avoid 
duplicating efforts. Do you think a single food agency would improve 
the safety of our food supply?
    Answer 3. No. As you are aware, the Administration looked into this 
issue and concluded that the food safety and food defense goals of the 
Administration are better advanced through enhanced interagency 
coordination rather than through the development of legislation to 
create a single food agency. The Federal food safety partners are 
working well with each other and with our other partners.
    The government's response to the recent E. coli outbreak is a good 
example of the close and effective working relationships we enjoy with 
our Federal and State food safety partners. Communication between the 
key agencies during this outbreak investigation worked extremely well.

                      QUESTIONS OF SENATOR KENNEDY

    Question 1a. The FDA is charged with ensuring the safety of the 
U.S. food, drug and medical device supply. How many inspectors does the 
FDA employ?
    Answer 1a. In fiscal year 2006, FDA had 1,363 investigators working 
in all five program areas: Foods, Human Drugs, Biologics, Animal Drugs 
and Feeds, and Devices and Radiological Health.

    Question 1b. Are inspectors segregated by field or area of 
expertise?
    Answer 1b. FDA investigators are cross-trained to perform multiple 
types of inspections and may conduct any combination of inspections in 
the foods, human drugs, biologics, animal drugs and feeds, and devices 
and radiological health program areas. In addition to inspections, FDA 
field investigators conduct domestic and import investigations; sample 
collections; import field exams; recall and consumer complaint follow-
ups; emergency response support (e.g., hurricanes); foodborne outbreak 
tracebacks/traceforwards; and, special event support (e.g., national 
political conventions, G8 Summit, Olympics). Additional expertise in 
various program areas is obtained by some investigators as their 
careers advance.

    Question 1c. How many FDA inspectors are devoted to food safety 
inspections?
    Answer 1c. In fiscal year 2006, FDA had 640 investigators working 
in the foods program.

    Question 1d. How does training of food inspectors differ from other 
FDA inspectors?
    Answer 1d. All FDA investigators are required to successfully 
complete a common foundation of training (i.e., ``New Hire''), 
exercises, and On-the-Job Training (OJT) within an investigator's first 
12 months of employment. Training includes topics such as Food and Drug 
Law, Import Operations, FDA Establishment Inspection, Sample 
Collection, Aseptic Sampling, Good Manufacturing Practices for food, 
Field Examinations, Interviewing Techniques, Evidence and Proof, FDA 
Establishment Report Writing, Courtroom Testimony, Food Microbiological 
Control, Recalls of FDA Regulated Products, Destruction and 
Reconditioning, FDA Laboratory Orientation, and Special Investigations. 
At the completion of the New Hire Curriculum, each investigator is 
required to successfully complete a field audit conducted by a 
standardized auditor and is then designated a Level I Certified 
Investigator.
    Once the investigator completes the Level I Investigator 
certification, each is provided higher level training related to the 
regulated industries for which he/she will eventually conduct 
inspections. FDA regulates a broad breadth of industries--human drugs, 
veterinary drugs, medical devices, biologics, and foods. Each of these 
program areas has its own specific regulations and inspectional 
policies and procedures that are based on the science and risk 
associated with that particular commodity. These regulations, policies, 
and procedures serve as the basis for the training. The training is 
delivered in the form of web-based training, OJT, and class room 
courses. Some of the topic areas of courses associated with foods 
include: Foodborne Illness Investigations, Produce Farm Investigations, 
Tracebacks (produce), Seafood HACCP, Juice HACCP, Dairy HACCP, Basic 
and Advanced Low Acid Canned Foods, Acidified Foods, Food Code, 
Shellfish, and Dairy Products.

    Question 1e. In the previous year how many inspections were 
conducted at farms in the United States; in the Salinas Valley of 
California?
    Answer 1e. In fiscal year 2006, 22 growers (farms) of ``fresh'' 
vegetables and fruits were inspected by FDA and an additional 3 by the 
States under contract to FDA or under partnership with FDA. In 
addition, in fiscal year 2006, CalFERT investigated 8 farms as part of 
a foodborne illness outbreak investigation in Salinas Valley. CalFERT 
(California Food Emergency Response Team) is a joint California and FDA 
response team.

    Question 1f. In the previous year how many inspections were 
conducted at processors of produce grown in the United States; in the 
Salinas Valley of California?
    Answer 1f. In fiscal year 2006, 442 processors (manufacturers or 
repacker/packers) of ``fresh'' vegetables and fruits were inspected by 
FDA and an additional 322 by the States under contract to FDA or under 
partnership with FDA.
    In fiscal year 2006, 23 Salinas Valley processors (manufacturers or 
repacker/packers) of ``fresh'' vegetables and fruits were inspected by 
FDA.

    Question 2a. In August 2006, the FDA in conjunction with the 
California Department of Health Services began its Lettuce Safety 
Initiative. Part of this initiative was to visit farms, processors and 
packagers of fresh produce in California. How many inspections were 
planned as part of this initiative?
    Answer 2a. Thirty-five to forty total operations, specifically 
assessments and inspections, were planned under the Lettuce Safety 
Initiative Assignment with emphasis placed on the following operations 
in priority order: harvester assessments, processor inspections, and 
cooler/packer/shipper assessments.

    Question 2b. How many inspectors were assigned to conduct these 
inspections?
    Answer 2b. Three CalFERT investigators conducted inspections and 
three CalFERT investigators conducted assessments.

    Question 2c. What were the specific goals of these inspections and 
what areas of expertise did the FDA inspectors possess?
    Answer 2c. The goals of inspections and assessments were as 
follows: reduce public health risk associated with an FDA-regulated 
product by focusing on the product, agents, and areas of greatest 
concern; assess adoption and implementation of Good Agricultural 
Practices (GAPs); assess awareness and degree of adoption of lettuce 
specific commodity guidance; assess the use of Good Manufacturing 
Practices (GMPs); and document observations that identify practices 
that potentially lead to product contamination in order to develop and/
or refine guidance and policy that will minimize opportunities for 
future outbreaks and/or identify research needs. Investigators assigned 
to perform inspections possessed knowledge, skills and abilities to 
analyze and evaluate data and practices in order to determine and 
document compliance and/or deficiencies with respect to the FD&C Act 
and regulations. Investigators assigned to perform assessments also 
possessed the aforementioned knowledge, skills and abilities, and had 
received formal training in produce farm investigations.

    Question 2d. What was the timeframe for the inspection portion of 
the Lettuce Safety Initiative? What was the timeframe for the analysis 
and implementation of any recommendations?
    Answer 2d. The inspection portion was intended to continue until 
35-40 operations were completed or until end of harvest season, which 
typically ends in November each year.
    The Lettuce Safety Initiative Assignment was placed on hold due to 
the spinach E. coli O157:H7 outbreak investigation, which began on 
September 13, 2006. Upon receiving notification of the outbreak, 
resources were redirected to the outbreak investigation and work. 
Approximately 30 operations (inspections and assessments) were 
completed by September 13, 2006.

    Question 2e. Given that these inspections had to be canceled due to 
the outbreak of E. coli O157:H7 contaminated spinach when does the FDA 
plan on resuming these inspections?
    Answer 2e. FDA's San Francisco District anticipates that work will 
resume on the Lettuce Safety Initiative during the next harvest season.

    Question 3a. The Public Health Security and Bioterrorism 
Preparedness Act of 2002 granted the FDA significant new authorities 
over domestic food products and production. Did these new authorities 
help speed the Federal response to this outbreak?
    Answer 3a. Among other provisions, section 306 of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (BT 
Act) provided FDA with important new authority to require the 
establishment and maintenance of records by persons who manufacture, 
process, pack, transport, distribute, receive, hold, or import food. It 
further required persons to provide FDA with access to certain records 
during public health emergencies. As part of the traceback 
investigation, FDA reviewed records held by a number of firms, 
including warehouses, packers, processors, and farms. Firms were 
cooperative and voluntarily provided the records FDA requested; thus, 
FDA did not need to invoke its records access authority under the BT 
Act. (As you know, farms are not covered by the recordkeeping 
provisions of the BT Act.) It is possible that not all of the records 
we were provided would have existed in the absence of the BT Act's 
recordkeeping requirement.

    Question 3b. Had all of the implicated companies complied with the 
registration requirements?
    Answer 3b. Earthbound Farm (processor) and Pride of San Juan 
(grower, warehouse, packer/re-packer) both in California were found in 
the registration database. Natural Selection Foods, LLC, (processor) in 
San Juan Bautista, California is registered under the name Earth bound 
Farm. The statute exempts farms from the registration requirement.

    Question 3c. How useful was the ``one-step forward, one step back'' 
recordkeeping requirement in identifying the course of the contaminated 
product from farm to table?
    Answer 3c. This requirement is very helpful. As noted above in our 
response to 3(a), FDA obtained records from the processor and used 
those records to trace back to the growers and fields.

    Question 3d. Farms are specifically exempted from the registration 
requirements under this act. Would registration of farms have aided in 
the outbreak detection and mitigation process?
    Answer 3d. In this particular situation, we do not believe 
information that would have been available through registration of 
farms would have been necessary. Because of the specific information on 
bags of spinach and information provided by processors, FDA was able to 
obtain the information needed to identify the implicated farms. 
However, as we continue to evaluate what additional measures may be 
needed in the future, we will be considering whether any additional 
registration information would be helpful.

    Question 3e. Should farms that grow Ready-to-Eat produce which 
necessarily require less processing be required to register?
    Answer 3e. We are still in the process of evaluating what 
additional measures may be necessary to help prevent future outbreaks 
and minimize any that occur.

    Question 4. FDA has required all seafood processors to implement a 
Hazard Analysis Critical Control Points (HACCP) plan. Where does the 
legal authority for this action reside? Does FDA have the authority to 
require ready-to-eat produce growers, processors and packagers to 
design and implement Hazard Analysis Critical Control Points (HACCP) 
procedures? If so, where statutorily does this authority derive from?
    Answer 4. FDA issued the seafood HACCP regulation under various 
sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 
primarily sections 402(a)(1), (a)(4) and 701(a) (21 U.S.C. 342(a)(1), 
(a)(4), and 371(a)) and the Public Health Service Act, primarily 
section 361 (42 U.S.C. 264). (For further discussion of the legal basis 
for the seafood HACCP rule, see 60 FR 65095 (Dec. 18, 1995) and 59 FR 
4142 (Jan. 28, 1994)). Section 402(a)(1) of the FD&C Act provides that 
a food is adulterated if it bears or contains any poisonous or 
deleterious substance that may render the food injurious to health. 
Section 402(a)(4) of the FD&C Act provides that a food is adulterated 
if it has been prepared, packed, or held under insanitary conditions 
whereby it may have been contaminated with filth, or whereby it may 
have been rendered injurious to health. Section 701(a) of the FD&C Act 
authorizes the agency to adopt regulations for the efficient 
enforcement of the act. In addition, the Public Health Service Act 
authorizes FDA to make and enforce regulations to prevent the 
introduction, transmission, or spread of communicable disease.
    The FD&C Act provides a broad statutory framework for Federal 
regulation to ensure human food will not be injurious to health and to 
prevent commerce in adulterated foods. Further, the Public Health 
Service Act provides FDA with broad authority to issue regulations 
necessary to control the spread of communicable disease. For FDA to use 
these authorities to mandate HACCP in a particular circumstance, the 
agency must demonstrate a strong scientific basis to establish that 
such requirements are necessary to prevent food from being adulterated 
or to control the spread of communicable disease. The investigation 
into the recent E. coli outbreak is not yet completed. Once we have 
completed our current investigation, FDA will hold a public meeting to 
address the larger issue of foodborne illness linked to leafy greens. 
We also will examine whether improvements in the following four areas 
could help prevent or contain future outbreaks: (1) strategies to 
prevent contamination; (2) ways to minimize the health impact after an 
occurrence; (3) ways to improve communication; and (4) specific 
research. In addition, we will hold a series of meetings with industry 
groups to discuss ways to improve the safety of fresh produce. We will 
use all of this information to determine whether additional 
requirements are necessary and within FDA's authority to ensure the 
safety of ready-to-eat produce.

    Question 5. Dr. Reilly, of the California Department of Health 
Services Prevention Services, testified that ``The Salinas Valley 
appears to have systemic E. coli O157:H7 contamination in the 
environment that has led to a number of fresh produce associated 
outbreaks over time.'' The beef industry in its zero tolerance efforts 
to reduce E. coli contamination uses a ``test and hold'' procedure 
whereby a meat product is held while tests for the presence of E. coli 
O157:H7 are conducted. Does FDA posses the authority to require ``test 
and hold'' procedures to assure that fresh produce is safe to eat?
    Answer 5. We understand your question to be referring to voluntary 
testing of meat products for E. coli O157:H7 by the beef industry. The 
produce industry similarly could implement a voluntary test and hold 
procedure for fresh produce. The investigation into the recent E. coli 
outbreak is still ongoing, and FDA is still gathering information to 
determine what future actions, including regulation, may be necessary 
and within its authority to ensure the safety of ready-to-eat produce. 
FDA notes, however, that E. coli O157:H7 is not uniformly distributed 
in food and that even the presence of a very small amount of E. coli 
O157:H7 can cause illness. Therefore, testing cannot completely 
``assure that fresh produce is safe to eat.''

    Question 6. Dr. Reilly noted in his testimony that the fields that 
were the source of the contaminated spinach were located in an area of 
concern for the California Department of Health Services. If it was 
determined that a certain field or area was a persistent or recurring 
source of contamination, does FDA have the authority to restrict or 
direct that produce from these areas be prohibited from entering the 
food distribution system as Ready-to-Eat?
    Answer 6. Under the FD&C Act, adulterated food cannot be sold in 
interstate commerce, 21 U.S.C. 331(a), and is subject to regulatory 
action, such as seizure, 21 U.S.C. 334. Several adulteration provisions 
of the FD&C Act are potentially applicable to the circumstances 
described in the question. For example, food is adulterated if it bears 
or contains any poisonous or deleterious substance that may render the 
food injurious to health, 21 U.S.C. 342(a)(1). In addition, food is 
adulterated if it has been prepared, packed, or held under insanitary 
conditions whereby it may have been contaminated with filth, or whereby 
it may have been rendered injurious to health, 21 U.S.C. 342(a)(4). If 
FDA could establish that produce is adulterated, FDA would have 
authority to prohibit its distribution in interstate commerce.

    Question 7. During the hearing we heard from both Dr. Reilly and 
Dr. Whitaker that more research is required into the etiology and 
ecology of bacterial pathogens. What efforts to fund intra- and 
extramural research into bacterial contamination of fresh produce has 
the FDA undertaken?
    Answer 7. FDA's food safety research approach is threefold, 
involving an intramural program, and extramural program, and consortia 
with industry and/or academia. Additionally, to prioritize research 
needs and avoid duplication, FDA coordinates with its sister agencies 
within HHS, such as CDC, and with other Federal partners such as USDA.
    As we discussed in our testimony, our current research agenda is 
focused on improving the identification and detection of disease-
causing bacteria and toxins in a variety of foods. We are also studying 
possible intervention strategies, such as the use of thermal treatment 
and irradiation, which could be applied to fresh produce products to 
reduce the level of bacteria and viruses that are in or on the product.
    Some recent accomplishments on the subject of produce research 
include:

     Provided technical assistance to State, university, and 
industry efforts to plan research, risk assessments, and education 
outreach to enhance the safety of fresh produce.
     Collaborated with industry, in cooperation with State 
agencies and academia, to develop commodity-specific supply chain 
guidance for the commodities that have most often been associated with 
foodborne illness outbreaks (cantaloupe, lettuce/leafy greens, and 
tomatoes). We are working to finalize guidance on herbs and green 
onions.
     Issued the ``Draft Guidance: Guide to Minimize Microbial 
Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' in March 2006. 
The guidance contains recommendations to help fresh-cut produce 
processors reduce the risk of microbial contamination in their products 
and provides the agency's recommendations for control of hazards as 
they apply to fresh-cut produce. The agency expects final guidance to 
issue in fiscal year 2007.
     Conducted and supported research focused on: (1) 
identifying mechanisms of contamination of fresh produce with pathogens 
and preventing contamination; (2) identifying effective interventions 
to address contamination that has occurred; and (3) developing fast and 
sensitive analytical methods for the detection of pathogens on fresh 
produce.
     Developed a risk profile for Listeria monocytogenes in 
fresh produce.
     Started a risk profile for hepatitis A in fresh produce.

    FDA funded an interagency agreement with USDA/ARS to provide 
additional support to an ARS research project entitled ``USDA and FDA 
Collaborative Effort for the Study of E. coli O157:H7 in Pre-harvest 
Produce Environment.'' This study was conducted from October 1, 2005 
through September 30, 2006 and analyzed water samples from the Salinas 
watershed for E. coli O157:H7.
    FDA has also provided technical assistance to USDA/CSREES in the 
development of the recent Integrated Research, Education, and Extension 
Competitive Grants Program--National Integrated Food Safety Initiative 
solicitation (see http://www.csrees.usda.gov/funding/rfas/
food_safety.html).
    FDA/CFSAN has two consortia partnerships, leveraged through 
extramural cooperative agreements, that are involved in produce safety 
research. One partnership, the Joint Institute for Food Safety and 
Applied Research (JIFSAN), is with the University of Maryland, College 
Park. JIFSAN produce-related collaborative projects are available at 
http://www.jifsan.umd.edu/annualrep.htm.
    Another partnership, the National Institute for Food Safety and 
Technology (NCFST), is with the Illinois Institute of Technology and 
numerous food industry members and focuses on prevention and 
intervention research. Research conducted at NCFST has significantly 
supported the development of FDA's policy and regulatory response for 
juice HACCP and the safety of sprouted seeds and apples. NCFST annual 
reports, including publications in the public domain, are available at 
http://www.ncfst.iit.edu/main/home.html.
    FDA's produce-related research priorities currently under 
consideration include:

    (1) optimizing procedures for the recovery of virus particles from 
produce to integrate into detection methods;
    (2) methods for accurate identification and subtyping of E. coli, 
Salmonella, and Shigella pathogens;
    (3) monitoring of irrigation or wash waters and development of 
rapid detection assays; and,
    (4) assessing survival and/or growth of pathogens in packaged 
produce.

    Question 8a. There remains an outstanding scientific question 
regarding the ability of farm produce to internalize bacterial 
contamination via absorption from contaminated fields and/or ground 
water. This potential source of contamination poses a unique threat to 
the public, since such contamination could not be removed or mitigated 
during normal processing procedures. What efforts has FDA taken to 
answer this question?
    Answer 8a. FDA/CFSAN's NCFST consortia partner has conducted 
intervention studies on apples with internalized E. coli O157:H7. FDA 
has indicated that the role of bacterial contamination via adsorption 
from contaminated fields and/or ground water is a priority research 
need and has communicated this in the Produce Safety Action Plan and to 
the USDA research agencies and other stakeholders through meetings, the 
Lettuce Safety Initiative, and the November 30, 2006 Tomato Summit in 
Orlando, Florida, for example.

    Question 8b. If internalization of harmful bacteria does occur 
would this constitute adulteration?
    Answer 8b. Food is adulterated if it bears or contains any 
poisonous or deleterious substance that may render it injurious to 
health, 21 U.S.C. 342(a)(1). Food described in the question, that is, 
produce that contains harmful bacteria that ``could not be removed or 
mitigated during normal processing procedures'' contains a deleterious 
substance and would be adulterated under the FD&C Act.

    Question 8c. If such internalization occurred does the FDA possess 
the authority to require farms to certify that effective measures to 
prevent or mitigate such contamination take place?
    Answer 8c. Under the FD&C Act, producers of food, including farms, 
are responsible for ensuring that the food they produce is not 
adulterated. Producers bear this responsibility regardless of any 
certification they might make and are subject to injunction, criminal 
penalties, and seizure of their food for violations of the FD&C Act, 
such as causing food to become adulterated. Therefore, FDA usually does 
not rely on broad certifications to ensure the safety of food. 
Generally, FDA has authority to require that farms take measures 
necessary to prevent food from becoming adulterated and to prevent the 
spread of communicable disease.

    Question 9a. Dr. Reilly testified that fields that were the source 
of the contaminated spinach remain ``disked under.'' Was this a 
voluntary action by the farmers or was this mandated by the FDA, by 
California?
    Answer 9a. Two of the four implicated fields were barren. The 
remaining two fields contained product; however, the farmers 
voluntarily agreed to plow under the fields.

    Question 9b. What is the role of FDA in determining if produce from 
these fields should/can be allowed to be reintroduced into the Nation's 
food supply?
    Answer 9b. When specific fields or facilities are implicated in a 
foodborne illness outbreak investigation, FDA works with State 
officials and the firms involved to help ensure the safety of produce 
from these sources.

    Question 9c. Does FDA posses the authority to prevent these fields 
from returning to production if nothing is done to address the concerns 
of contamination?
    Answer 9c. The investigation into the recent E. coli outbreak is 
still ongoing, and FDA is still gathering and analyzing information 
related to the conditions on the implicated fields. If FDA were to 
determine that any spinach grown on a particular field would be 
adulterated because of the conditions on that field, then the 
adulteration prohibitions of the FD&C Act would be applicable, such as 
the prohibitions against introducing adulterated food into commerce, 21 
U.S.C. 331(a), and against adulterating any food in interstate 
commerce, 21 U.S.C. 331(b). Further, adulterated food is subject to 
seizure, 21 U.S.C. 334.

    Question 10. Mr. Brackett testified that the FDA has learned more 
from this outbreak than all other previous outbreaks combined. What is 
the timeframe for the FDA's investigation and subsequent 
recommendations?
    Answer 10. CalFERT expects to conclude the field investigation in 
December 2006 and expects to complete the comprehensive investigation 
report in February 2007.

    Question 11a. Mr. Reilly cites various sources of potential E. coli 
contamination. Two of these sources, manure used for fertilization and 
field proximity to infected livestock, raise important concerns 
regarding the use of antibiotics in animal feed stock. As the FDA 
recognized in 2005 when it banned the use of fluoroquinolones to treat 
sick poultry, the use of certain drugs in animals can adversely affect 
the ability to use these (or related) drugs to treat humans. Does the 
FDA have the legal authority to place extralabel use restrictions on an 
animal drug prior to the drug's being marketed when either a drug 
sponsor's own risk assessment or an internal FDA risk assessment finds 
that a potential drug approval presents a high risk of resistance 
adversely affecting human health? If so, has the FDA ever used this 
authority? If not, would it promote the public health if the FDA had 
such authority?
    Answer 11a. FDA issued an order in May 1997 (62 FR 27944) to 
prohibit the extralabel use of fluoroquinolone and glycopeptide drugs 
in food-producing animals. At the time of issuance of that order, 
fluoroquinolone drugs were approved and marketed for use in certain 
animal species. Although certain glycopeptide drugs were approved for 
use in humans at that time, no glycopeptide drugs were approved or 
marketed for use in animals nor are any drugs in the glycopeptide class 
approved for use in animals today. More recently, FDA issued an order 
in March 2006 (71 FR 14374) to prohibit the extralabel use of the anti-
influenza adamantane (amantadine and rimantadine) and neuraminidase 
inhibitor (oseltamivir and zanamivir) drugs in chickens, turkeys, and 
ducks. Although these anti-influenza drugs are approved for use in 
humans, these drugs are not approved or marketed for use in animals. 
Therefore, based on resistance concerns, FDA has previously prohibited 
the extralabel use of drugs that have not been approved for use in 
animals when FDA has found that the extralabel use of the drug in 
animals presents a risk to public health.

    Question 11b. Does the FDA now require drug sponsors to carry out 
pre-approval studies to determine potential resistance problems that 
are likely to occur if a drug is approved?
    Answer 11b. Prior to approving a new animal drug application, FDA 
must determine that the drug is safe and effective for its intended use 
in the animal. The Agency must also determine that an antimicrobial new 
animal drug intended for use in food-producing animals is safe with 
regard to human health (21 CFR 514.1(b)(8)). FDA considers an 
antimicrobial new animal drug to be ``safe'' if it concludes that there 
is reasonable certainty of no harm to human health from the proposed 
use of the drug in food-producing animals.
    FDA published guidance for industry (GFI #152) on this issue in 
October 2003 entitled, Evaluating the Safety of Antimicrobial New 
Animal Drugs with Regard to Their Microbiological Effects on Bacteria 
of Human Health Concern. This guidance document outlines a risk 
assessment approach for evaluating the microbial food safety of 
antimicrobial new animal drugs intended for use in food-producing 
animals. Alternative processes that may be more appropriate to a 
sponsor's drug and its intended conditions of use, may also be used to 
characterize the microbial food safety of that drug. FDA considers this 
information when evaluating drug safety as part of the new animal drug 
approval process.

    Question 11c. In early 2004, FDA raised with the drugs' sponsors 
that several approvals for the use of penicillin in animal feeds are 
inappropriate due to concerns about antimicrobial resistance, but it 
has subsequently taken no action to withdraw these approvals. Does FDA 
have the legal authority to withdraw approvals of animal drugs that the 
agency has determined present a high risk of resistance adversely 
affecting human health in a timely manner?
    Answer 11c. FDA has the authority to withdraw the approval of a new 
animal drug application, however the agency must first notify the 
holder of the application and afford an opportunity for a hearing on 
the proposal to withdraw such application. The agency can initiate such 
proceedings if evidence shows, for example, that such drug is unsafe 
for use under the conditions of use upon the basis of which the 
application was approved.
    In addition, the Secretary may suspend approval of a new animal 
drug application if the Secretary finds that there is an imminent 
hazard to human or animal health. The Secretary must give the applicant 
notice of such action and afford the applicant the opportunity for an 
expedited hearing on the suspension. This authority cannot be 
delegated.

    Question 12a. The regulations governing FDA advisory committees 
require that FDA keep either detailed minutes of all advisory committee 
meetings or less detailed minutes when a transcript of the meeting is 
to be made available. These minutes are to include among other things a 
complete and accurate description of matters discussed and conclusions 
reached. 21 CFR 14.60(b)(4) The accuracy of the minutes is to be 
approved by the committee and certified by the Chairman. 21 CFR 14.60. 
The summary available at the FDA's Website for the VMAC Winter 2005 
meeting is described as the Acting Chairperson's Summary. Are these 
considered by the FDA to be the official minutes of the meeting?
    Answer 12a. CVM relies on the transcript of the VMAC as the 
official record of the meeting. The Chair's summary has historically 
been posted prior to availability of the transcript as a means of 
informing the public that the meeting was held and to describe the 
matters discussed and conclusions reached.

    Question 12b. If the summary described above is not the official 
minutes of the meeting then were they approved pursuant to 21 CFR 
14.22(i)(4) which states that notes, minutes or reports prepared by a 
committee member have no status or effect unless adopted into the 
official minutes by the committee.
    Answer 12b. The Chair's summary is not the official minutes of the 
meeting and was not adopted into the official minutes by the committee. 
The Chair's summary is intended to summarize the meeting as a 
convenience for the public prior to availability of the transcript but 
are not part of the official record.

    Question 12c. Please describe the process that the Center for 
Veterinarian Medicine uses in the preparation and dissemination of the 
minutes of VMAC committees and compare them to the processes used by 
other FDA advisory committees. For instance, the minutes from CDERS 
Antiviral Drugs Advisory Committee meetings present a detailed tally of 
each of the votes taken by the advisory committee.
    Answer 12c. CVM, as do the other FDA Centers, relies on the 
transcript of its advisory committee meetings as the official record of 
the meeting. Transcripts are posted on FDA's Website. CVM's executive 
secretary does not prepare detailed minutes of the meetings.

       Response to Questions of Senator Enzi and Senator Kennedy 
                       by Lonnie J. King, D.V.M.

                       QUESTIONS OF SENATOR ENZI

    Question 1. I am very interested in the 2004 Produce Safety Action 
Plan. I recognize that much of this plan rests with FDA and the 
industry, but CDC has an important role to play. What is needed to help 
your agency fulfill its role in the collection and analysis of outbreak 
surveillance data to help assess the impact of the Action Plan?
    Answer 1. As regulatory processes develop, it is critical to 
include objective external assessments of their impact. Public health 
surveillance data are an important way to track the success of 
prevention plans that target either specific disease-causing pathogens 
or specific foods. The quality and usefulness of outbreak reports, like 
all surveillance data, depend critically on the resources, training, 
and skills of the primary public health officials in local and State 
health departments, who investigate the vast majority of the over 1,000 
foodborne outbreaks investigated each year and who report the results 
of those investigations. Resources permitting, CDC could conduct 
analysis of data to present annual summaries of reported produce-
related outbreaks in general, with specific analyses on leafy greens, 
tomatoes, melons, sprouts, spring onions, and juice.

    Question 2. How does CDC draw the line between a cluster and an 
outbreak?
    Answer 2. The distinction lies in the public health investigation. 
For foodborne diseases, CDC defines a cluster as a group of people with 
the same illness that may possibly be related. For example, a cluster 
of illness may be an unexpectedly high number of cases in a particular 
time and place that are caused by the same subtype of pathogen. After a 
cluster is detected, an investigation may define a particular common 
source or exposure. Such clusters are then called outbreaks. Thus, an 
outbreak is a cluster of illness that has been investigated, and shown 
to be related to a particular exposure the group had in common, such as 
eating a particular food, or eating in one particular restaurant. 
Clusters can be investigated in several ways, and the decision of which 
clusters to investigate and which methods to use is a major part of the 
science of field epidemiology.

    Question 2a. Do the cases have to be multistate or multisite to be 
considered an outbreak?
    Answer 2a. They do not. Foodborne outbreaks come in many shapes and 
sizes, depending on the nature of the contamination event. When a food 
is contaminated and mishandled in one kitchen, the outbreak will affect 
just those persons that ate foods from that kitchen, who may be one 
family, company, school, catered reception, or the patrons of one 
restaurant. If a food is contaminated earlier in the food chain, for 
example on the original farm or early in the processing, and then is 
distributed to multiple kitchens and served to many different people in 
many settings, then the outbreak will affect persons scattered across a 
wide area, depending on how that food was distributed.

    Question 2b. How and when does CDC determine that a multistate E. 
coli outbreak has occurred?
    Answer 2b. This can occur in several ways. Persons who are 
investigating local clusters may realize that their outbreak may be 
associated with a nationally distributed food, and a broadened search 
for cases identifies other cases around the country that are part of 
the same outbreak. Sometimes there are separate local investigations 
that independently come to similar conclusions, and it then becomes 
apparent that the two clusters are part of the same larger outbreak. 
Sometimes an increase in infections caused by a specific type of 
pathogen may be noted over a wide region, without a local outbreak to 
call attention to it. Public health capacity to link together the 
apparently separate outbreaks and cases has been greatly improved in 
recent years by application of DNA fingerprinting to the bacteria 
themselves.
    CDC has developed and directs PulseNet, a public health laboratory 
network operational in all 50 States and in Federal food regulatory 
agencies. The laboratories in PulseNet conduct DNA ``fingerprinting'' 
of E. coli O157 and other bacteria, add those fingerprints to the 
national database at CDC, and compare the fingerprints with others 
being identified in other States. When two clusters in different States 
turn out to have the same pattern, or when an unexpectedly large number 
of infections with the same fingerprint show up in multiple States, 
PulseNet recognizes this as a multistate cluster. This cluster will be 
investigated, usually in collaboration with OutbreakNet (the network of 
epidemiologists in the local and State health department and CDC who 
investigate foodborne disease outbreaks). If a common food or other 
source is identified by the investigation, then the multistate cluster 
becomes a multistate outbreak. It can also happen that an apparently 
local outbreak, detected and investigated in one jurisdiction, is the 
initial event of a larger outbreak. Therefore, CDC encourages reporting 
of local outbreaks and adding the PulseNet fingerprints of all 
outbreaks, large and small, to the database. CDC has developed 
extensive communication networks so that State health officials can 
report clusters and outbreaks rapidly to CDC and to each other. 
Frequent communication about suspected outbreaks and food vehicles is 
enhanced by formal and informal communication channels, including the 
foodborne outbreak listserv maintained by CDC's OutbreakNet 
epidemiologists, EpiX notifications, direct phone calls, and the 
PulseNet web-board.
    Many of the infections transmitted by contaminated food are also 
transmitted through water, or directly from animals, or by other ways. 
Thus, finding a cluster of E. coli O157 infections does not 
automatically mean there is a contaminated food source. However, as 
soon as there is a suspicion about a particular food, CDC informs the 
appropriate Federal regulatory agency, so they are aware of the 
investigation and begin to play their part.

    Question 2c. When did CDC determine in the recent case of bagged 
spinach that a multistate outbreak had occurred?
    Answer 2c. A multistate outbreak related to spinach was judged 
likely on September 13, and conclusively on September 14. CDC was first 
informed on September 8 of a local cluster of E. coli O157 infections 
in Wisconsin that had been detected by local case surveillance and by a 
limited number of PulseNet patterns linking local cases. On that day, 
Wisconsin posted the DNA ``fingerprint'' pattern on the general 
PulseNet communication Website, making it available to all PulseNet 
participants, including all other States, CDC, and regulatory agencies. 
At that time, there was no unusual number of recent postings of this 
pattern among other States. That same day, the Wisconsin State 
epidemiologist called the head of CDC Foodborne Outbreak Response and 
Surveillance Team to discuss the cluster, and the investigative 
approach Wisconsin was taking. By September 13, the investigation in 
Wisconsin had progressed and suspicion was increasing about several 
possible foods, including leafy greens and a fruit. That same day, 
epidemiologists in Oregon contacted CDC to discuss a very small cluster 
of cases they were investigating that they thought might have an 
association with leafy greens. An ad hoc conference call by CDC 
immediately connected Oregon and Wisconsin investigators; during that 
call the two States realized that they both were particularly 
suspicious of spinach. At the end of that call, the CDC epidemiologist 
called FDA officials to inform them that there appeared to be a 
multistate cluster with the strong possibility that fresh spinach was 
the source, and through the foodborne outbreak listserv, all 50 States 
were notified of the possible connections. The next day, September 14, 
CDC held a conference call among the State foodborne epidemiologists of 
OutbreakNet to gather further information. By the end of that call, a 
number of States had reported cases with the same DNA fingerprint, for 
which investigations indicated a strong association with fresh spinach. 
The speed of moving from identification of a local cluster (on 
September 8) to detection of a multistate cluster (September 13) to 
identification of a multiple State outbreak strongly associated with a 
particular food (September 14) was extremely swift.

    Question 3. How many E. coli cases are reported to CDC on a day-to-
day basis?
    Answer 3. Approximately 3,400 E. coli DNA ``fingerprint'' patterns 
are uploaded to the CDC PulseNet database each year. The infection is 
seasonal, with a peak in the late summer and early fall, and relatively 
few in the colder months. During a typical September, PulseNet receives 
reports of 440 E. coli O157 patterns, or 20 per working day.

    Question 3a. How many of these are E. coli O157:H7 cases?
    Answer 3a. Of these, approximately 87 percent are reported as E. 
coli O157:H7, 9 percent are reported with a serotype other than 
O157:H7, and 4 percent with serotype undetermined or pending. Other E. 
coli serotypes besides O157:H7 can cause similar illness, but they are 
less frequently recognized by clinical diagnostic laboratories and 
reported to State Health Department Laboratories. CDC is currently 
planning to increase capacity in State public health laboratories to 
detect and identify these other E. coli.

    Question 3b. How does the background level of E. coli cases 
reported influence the determination of whether or not an outbreak is 
occurring?
    Answer 3b. Most reported cases of E. coli O157 infection are so-
called sporadic cases that do not have an apparent connection to any 
cluster. Detecting a cluster among the sea of sporadic cases is similar 
to picking out a radio signal from the background static noise. If the 
background level of cases is high, then a large surge in cases is 
needed to stand out above the background level. Part of the power of 
the PulseNet system is its ability to make a signal stand out from the 
background noise, thus making cluster detection easier. The PulseNet 
database contains hundreds of different E. coli O157 patterns. Some 
patterns are common, others are rare. For example, if a cluster of 15 
ill persons occurs that is spread across several States in a week, it 
may be hard to identify against the background of 100 cases that might 
be reported that week. However, if the 15 E. coli strains have 
identical fingerprint patterns, they may stand out easily against the 
background of the 5 cases with that pattern that might usually be 
reported in a week. Thus, PulseNet makes it possible to detect clusters 
that would otherwise be missed, and can detect some clusters when they 
are small, that would otherwise not be detected until they grew large.
    Once an investigation of a cluster begins, PulseNet similarly can 
play a critical role in defining which cases to include in the 
investigation. This can greatly improve the efficiency and speed of the 
investigation, because it means that the OutbreakNet investigators can 
concentrate the investigation on the cases with matching fingerprints 
patterns, thus increasing the likelihood of pinpointing the cause of 
illness.

                      QUESTIONS OF SENATOR KENNEDY

    Question 1. What is the current classification of the death of June 
Edith Dunning, the Maryland resident who died on September 13th and is 
suspected to be a fourth fatality in the recent outbreak?
    Answer 1. That fatal case is classified as a ``suspect case.'' In 
the outbreak of E. coli O157:H7 infection due to spinach, CDC, State 
and local investigators agreed to working case definitions, including 
definitions for confirmed and suspect cases. A confirmed case required 
either an E. coli O157 isolate demonstrating the outbreak strain DNA 
fingerprint pattern as determined by pulsed-field gel electrophoresis 
(PFGE), or consumption of spinach that when cultured yielded the 
outbreak strain of E. coli O157. It was also agreed that cases with E. 
coli O157 infection without isolate PFGE information and who had 
consumed raw spinach (of which no culture was available) were 
classified as suspect cases.
    The outbreak investigation is not yet closed. To date, CDC has 
released only confirmed case counts in summary statistics concerning 
this outbreak. Future reports, however, will include details concerning 
both confirmed and suspect cases.

    Question 2. The classification of Judith Dunning's death seems to 
have been complicated by a number of institutional mistakes including a 
lost or unaccounted sample. Are these mistakes indicative of systemic 
problems with the outbreak detection apparatus?
    Answer 2. This case was the subject of an intense investigation at 
local, State and Federal levels. The patient was initially diagnosed 
with a different illness, and later diagnosed with E. coli O157. 
Although it had been identified in the clinical laboratory, the E. coli 
strain isolated from the patient was not retained or forwarded to the 
State public health department laboratory. Later efforts to recover E. 
coli O157 from the discarded laboratory diagnostic plate, from a biopsy 
specimen, and from leftover food were unsuccessful. Foodborne outbreak 
detection and investigation depends in part on submitting strains of E. 
coli O157 and other pathogens from clinical diagnostic laboratories to 
State laboratories for PulseNet fingerprinting. Some States require 
this submission to be done routinely, while others request it but do 
not make it mandatory.
    Maryland regulations require the clinical laboratory director to 
report the isolation of E. coli O157:H7. Sending an E. coli O157:H7 
isolate to the State public health laboratory is routinely requested 
but is not mandatory. The laboratory associated with this case has 
routinely submitted isolates in the past. Although it is not clear that 
a requirement for routine submission of E. coli isolates would have 
influenced the specific sequence of events in Maryland, this issue 
reflects the broader need to strengthen systems for submission and 
analysis of isolates as a vital part of public health surveillance in 
all States.

    Question 3. Were sufficient laboratory personnel and equipment 
available to monitor the outbreak?
    Answer 3. The large E. coli O157 outbreak traced to spinach 
stretched resources at local, State and Federal levels. Investigative 
capacity was found by borrowing resources from other food safety 
programs, and by CDC personnel conducting some interviews with cases 
and healthy controls on behalf of health authorities in some States. 
Laboratory capacity was strained even further, and in particular the 
capacity of local and State health department laboratories to rapidly 
transfer the E. coli O157:H7 strains from patients, to the public 
health laboratory by courier, to fingerprint them and to upload the 
fingerprint patterns to PulseNet. However, even with these adjustments, 
the response to this outbreak illustrates the importance of existing 
public health networks and demonstrates what a robust public health 
system can accomplish.

       Response to Questions of Senator Enzi and Senator Kennedy 
                   by Kevin Reilly, D.V.M., M.P.V.M.

                       QUESTIONS OF SENATOR ENZI

    Question 1. There is a history of outbreaks of foodborne illness 
traced to produce grown in California's Salinas Valley dating back to 
1995. Why is this area so susceptible to E. coli contamination?
    Answer 1. Although 9 of 20 outbreaks of E. coli O157:H7 associated 
with green leafy produce have been traced back to the Salinas Valley in 
the past 11 years, multiple farms have been implicated, and no single 
risk factor has emerged to explain this association. A large proportion 
of the commercial sale of lettuce, spinach and other green leafy 
vegetables across the country comes from the Salinas Valley. We know 
that E. coli can contaminate produce on the farm in several ways: 
through irrigation or other (flooding) water sources, fertilization 
(uncomposted manure), poor farm worker hygiene, contamination from 
wildlife carrying the bacteria, or contamination from domestic animals 
(cattle) carrying the bacteria. The science is not yet completed on how 
these factors come together in this region to result in contamination 
reaching the produce in the fields and ultimately surviving processing 
at levels that lead to foodborne illness outbreaks.

    Question 2. How are the California Department of Health Services 
and the California produce industry working to develop a longterm plan 
to prevent these food-
borne outbreaks? What are the obstacles to developing a comprehensive 
longterm plan? What metrics could be developed for the plan to 
determine how well it is working?
    Answer 2. CDHS has been working with FDA and Industry for several 
years. Recently, the California produce industry submitted a proposal 
to implement mandatory Good Agricultural Practices (GAPs) as a 
requirement under a ``Marketing Order'' program being developed by the 
industry. CDHS is currently reviewing this proposal that includes 
specific metrics for risk factors such as water, compost, and proximity 
to livestock operations. Obstacles include a lack of research in many 
areas including how pathogens come into contact with ready to eat 
produce, how pathogens survive or grow in the environment, and what 
additional processing measures can be taken to reduce the risk of 
contamination.

                      QUESTIONS OF SENATOR KENNEDY

    Question 1. How many inspectors does California employ to monitor 
food safety? How many times a year are farms inspected and do these 
inspections take into account that Salinas California apparently has an 
increased likelihood of producing contaminated produce?
    Answer 1. The California Department of Health Services employs 
approximately 42 Food and Drug Investigators with peace officer status 
to inspect processed food facilities, canneries and wholesale food 
facilities statewide. In addition, county public health and 
environmental health departments employ several hundred inspectors to 
conduct routine retail food facility inspection programs. California 
law does not currently provide for routine on-farm inspections for good 
agricultural practices or food safety by CDHS. The Department of Health 
Services conducts site visits and investigations when farms are 
implicated as the source in foodborne illness.

    Question 2. Fresh lettuce and spinach grown and processed in the 
Salinas in California has been linked to 8 of the last 19 E. coli 
outbreaks that have occurred since 1995. Given your States interest in 
maintaining a robust national market for your agricultural products 
what additional measures are you considering to ensure continued 
consumer confidence? Have your colleagues at the national level been 
adequately engaged in these efforts?
    Answer 2. The best way to ensure consumer confidence in California 
produce is for California to produce safe products that do not cause 
foodborne illness. To produce that safer product, we need a system that 
ensures that all farms are utilizing an enforceable, standardized, and 
verifiable set of scientifically-based good agricultural practices, and 
that the practices are adhered to 100 percent of the time. California 
agriculture has proposed a program that includes mandatory 
implementation of standardized good agricultural practices under a 
``Marketing Order'' process identified in both Federal and State law, 
and independently verified under the California Department of Food and 
Agriculture.

    Question 3. In your experience, was the response to the outbreak by 
the FDA and the CDC sufficiently robust? Did they have adequate numbers 
of inspectors and investigators to monitor and respond to the crisis?
    Answer 3. The Federal response to this outbreak was rapid and well 
coordinated. CDC and FDA teamed up to conduct a national teleconference 
as soon as evidence of a multi-state outbreak was determined, and 
maintained that excellent communication with State health officials 
throughout the investigation. On the same day that the initial 
notification was made, CDHS met with FDA and planned the Food Emergency 
Response Team (Cal-FERT) strategy for investigating in the Salinas 
Valley. FDA and CDHS members of the Cal-FERT team traveled to Salinas 
that evening to start the investigation onsite. FDA and CDHS together 
contacted the processing firm and worked in very close partnership 
throughout the investigation. The team investigation in California 
serves as a national model for State-Federal cooperation and success in 
response to foodborne illness.

    Question 4. Does California have the authority to issue a mandatory 
recall of produce grown or processed in California?
    Answer 4. No. State law does not authorize CDHS to issue a 
mandatory recall.

    Question 5. You testified at the hearing that ``the Salinas Valley 
appears to have systemic E. coli O157:H7 contamination in the 
environment that has lead to a number of fresh produce associated 
outbreaks over time.'' The beef industry in its zero tolerance efforts 
to reduce E. coli contamination uses a ``test and hold'' procedure 
whereby a meat product is held while tests for the presence of E. coli 
O157:H7 are conducted. Does California possess the authority to require 
``test and hold'' procedures to assure that fresh produce is safe to 
eat?
    Answer 5. CDHS does not have specific statutes requiring a test and 
hold process for fresh produce. Growers and processors are required to 
do what is necessary to produce a safe product. We believe that we can 
never test our way to food safety. Testing is an important tool, but to 
provide safer fresh produce, we must have a system that ensures that 
all farms are utilizing an enforceable, standardized, and verifiable 
set of scientifically-based good agricultural practices, and that the 
practices are adhered to 100 percent of the time.

    Question 6. In January of this year the California Department of 
Health Services sent a letter to the Western Growers Association. This 
letter highlighted the concerns raised by FDA in their November letter. 
In addition your department stated they were considering additional 
measures including the potential need for additional statues or 
regulations that include mandatory Good Agricultural Practices and/or 
mandatory Hazardous Analysis Critical Control Points for fresh cut 
produce. In light of the continued outbreaks are these measures likely 
to be implemented?
    Answer 6. It is important that these measures be integrated into 
scientifically-based good agricultural practices that must be 
implemented in California.

    Question 7. In light of the increasing number of outbreaks the 
Center for Science in the Public Interest has petitioned California to 
develop and implement mandatory and not voluntary compliance guidelines 
for growers and processors. Can you update this committee on your 
department's consideration of that petition?
    Answer 7. CDHS is working closely with the industry and the 
California Department of Food and Agriculture to develop a requirement 
for producers to follow standardized good agricultural practices under 
the auspices of a marketing order.

    Question 8. You testified that the fields that were the source of 
the contaminated spinach remain ``disked under.'' Was this a voluntary 
action by the farmers or was this mandated by the FDA or by California? 
What is the role of the California Department of Health Services in 
determining if produce from these fields should/can be allowed to be 
reintroduced into the Nation's food supply? Does California possess the 
authority to prevent these fields from returning to production if 
nothing is done to address the concerns of contamination?
    Answer 8. Two of the four owners of implicated farms voluntarily 
disked under produce growing on the implicated fields. The other two 
fields were barren and continue to have no fresh, ready to eat products 
planted. CDHS in partnership with FDA will evaluate the investigation 
findings and determine what the next steps will be with the implicated 
farms. State law provides CDHS with product embargo authority to 
prevent contaminated or adulterated products from entering commerce.
    Response to Questions of Senator Enzi by Robert Whitaker, Ph.D.
    Question 1. There is a history of outbreaks of foodborne illness 
traced to produce grown in California's Salinas Valley dating back to 
1995. Why is this area so susceptible to E.coli contamination?
    Answer 1. First, we do not know scientifically that the Salinas 
Valley is more susceptible to E.coli contamination than any other area 
where leafy green produce is grown. In fact, State and Federal 
investigations following the outbreaks since 1995 in this area have not 
definitively indicated what the source of the contamination has been. 
What has been stated publicly by some is speculation based on 
assumptions and not what the scientific investigations have revealed. 
This has placed a tremendous amount of pressure on the fresh produce 
industry to prevent future outbreaks without knowing the sources of 
previous contamination. It is one of the major reasons I call on 
Congress in my testimony for increased dedication and resources to 
fresh produce food safety.
    However, what we do know is that urban encroachment and certain 
environmental rules related to waterways and riparian areas encourage 
feral and domestic animals near the fields in Salinas. Whether this has 
actually contributed to the contamination resulting in outbreaks is 
unknown, but the industry is focusing a tremendous amount of resources 
inspecting, monitoring, and correcting for animal activity.

    Question 2. How is prepackaged produce washed? Does this process 
remove E.coli from green leafy produce?
    Answer 2. The washing process is one of the best researched and 
scientifically supported points of the leafy greens process. Details 
will vary from company to company, but the washing process is generally 
as follows: first, leafy greens are trimmed, either in the field or in 
the processing plant, to remove obvious signs of dirt and decay. Large 
leafy greens, like iceberg and Romaine lettuce, may be mechanically 
chopped to salad sized pieces just prior to washing. The first wash of 
a ``triple wash'' process removes remaining surface dirt from the 
field. The greens are then removed from the first bath and transferred 
into a second, separate bath that contains a disinfectant chemical, 
like chlorine. The disinfectant level is a key component of the in-
plant food safety system and is actively monitored. The leafy greens 
are agitated in both baths, like clothes are in a washing machine, to 
further ``scrub'' the greens. The greens are removed from this second 
bath and either put through a third bath or showered with microbially-
disinfected water, before being shaken or spun dry and packaged. The 
triple wash process is most often automated, with little if any human 
contact, and has been optimized to be more controlled and effective 
than what consumers or foodservice operators could do in a kitchen.
    Chemical disinfectants commonly used in wash water include chlorine 
compounds such as hypochlorite or chlorine dioxide, peracetic acid, 
ozone and others. Properly used, the disinfectant in the wash water is 
very effective at destroying bacteria like E.coli O157:H7 or 
Salmonella, when the bacteria are exposed on the produce or floating in 
the wash water, and so is very effective at preventing cross-
contamination from leaf to leaf. However, all of these chemical 
disinfectants only eliminate 90-99 percent of the bacteria on the 
produce itself. Surviving bacteria are thought to be protected from the 
disinfectants by ``hiding'' in crevices, under waxy plant layers or 
biofilms, or internalized through cuts where the disinfectant cannot 
reach. That is why washing cannot be relied on as a kill step, like 
pasteurization.

    Question 3. Your testimony indicated that washing in chlorinated 
water is not a ``kill step'' for spinach. I hope that we could always 
prevent E.coli contamination, but if we can't, is there anything on the 
horizon that would be a good kill step for spinach? What do you see as 
holding the most promise for reducing and containing outbreaks of 
foodborne illness associated with fresh produce?
    Answer 3. We encourage a bimodal approach to food safety research. 
First we immediately need investment in research examining ways to 
prevent contamination from occurring throughout the supply chain. 
However, to your point, we must encourage researchers to continue to 
investigate technologies that can provide an adequate kill step for 
fresh produce and still retain the high quality and health benefits 
that consumers demand in these commodities.
    For example, USDA has developed a steaming process that eliminates 
surface contamination on melons while retaining the quality of the 
product. At the same time, researchers across the country are exploring 
the use of irradiation. Unfortunately, neither of these processes has 
yet proven viable for leafy greens. Again, as my testimony has stated, 
a strong and robust research agenda for fresh produce is an immediate 
area where Congress and the Federal Government can help the fresh 
produce industry overcome the many challenges you have highlighted in 
your questions.
      Response to Questions of Senator Enzi by Terri-Anne Crawford
    Before I answer the questions below, I'd like to give a high level 
overview of RFID technologies, which will help frame the responses by 
giving a general knowledge of RFID for the audience.
    Auto Identification (Auto-ID) is the broad term given to a host of 
technologies that are used to help machines identify objects. Some of 
the technologies that fall under the Auto Identification (Auto-ID) 
umbrella include bar codes, smart cards, voice recognition, some 
biometric technologies (retinal scans, for instance), optical character 
recognition, and radio frequency identification (RFID). Auto-ID is 
often coupled with automatic data capture. That is, companies want to 
identify items, capture information about them and somehow get the data 
into a computer without having employees type it in. The aim of most 
Auto-ID systems is to increase efficiency, reduce data entry errors, 
and free up staff to perform more value-added functions.
    RFID is a generic term for technologies that use radio waves to 
transfer data. RFID technology consists of 2 basic components, an RFID 
tag or transponder and an RFID reader or scanner. An RFID tag can be 
applied to almost any entity and then can be used to identify that 
entity.
    RFID readers or scanners are a proximity reader, which means they 
do not require contact between the reader and the tagged entity. This 
ability to read the information from the tags without line-of-sight or 
direct contact is the primary advantage of RFID tags for identifying 
product or other entities. The bar code's biggest shortcoming is that 
it is a line-of-sight technology. That is, a scanner has to ``see'' the 
bar code to read it, which means people have to orient the bar code 
towards a scanner for it to be read. RFID tags can be read as long as 
they are within range of a reader. Also, standard bar codes identify 
only the manufacturer and product, not the unique entity. The bar code 
on one milk carton is the same as every other carton from the same 
manufacturer, making it impossible to identify which carton might pass 
its expiration date first or to track the exact path or location of a 
particular carton within the supply chain.
    There are several methods of identifying objects using RFID, but 
the most common is to store a serial number that identifies a product 
and perhaps other information, on a microchip that is attached to an 
antenna (the chip and the antenna together are called an RFID 
transponder or an RFID tag). The antenna enables the chip to transmit 
the identification information to a reader. The reader converts the 
radio waves returned from the RFID tag into a form that can then be 
passed to computers that can make use of it.
    There are 3 different types of RFID tags, all function a bit 
differently and with different read range capabilities. There are 
active tags, semi-passive and passive tags.

     Passive RFID tags have no internal power supply. They rely 
on the current generated from received radio signals to power and 
transmit a response; therefore they are not capable of continually 
transmitting data. Passive tags have a read distance ranging from about 
4 inches to 15 feet depending upon radio frequency and antenna used. 
Passive tags are the least expensive tags, due to not having a power 
source on-board.
     Semi-Passive RFID tags have batteries to run the chip 
circuit so that the tags are constantly powered. However, they still 
need power from incoming radio signals to transmit a response.
     Active RFID tags also known as beacons have their own 
internal power source which is used to power the integrated circuit and 
generate the outgoing signal. Instead of just responding to incoming 
signal from the reader they can broadcast their own signal at regular 
intervals of time. Active tags have a longer range of up to 300 feet

    The Electronic Product Code (EPC) is a new product numbering 
standard under development by a division of GS1 (www.gs1.org) that can 
be used to detect, track, and control a variety of items using RFID 
technology. GS1 is the most implemented system of supply chain 
standards in the world. The EPC links to an online database and 
provides a secure way of sharing product-specific information 
throughout the supply chain. Basically, the EPC is a standard for 
product ``license plates.'' The primary difference between today's 
standard product bar code and the EPC is that the bar code identifies a 
unique product and the EPC contains additional information 
(serialization) that distinguishes each individual occurrence of that 
product. This is the difference between a computer just knowing that 
the product is a carton of Coca-Cola and knowing the distinct carton of 
Coke and information about that carton, such as it's lot number, 
manufacture date, expiration date and any place it has traveled through 
the supply chain.
    EPCglobal (www.epcglobalinc.org) is a product area or division of 
GS1 and is a member-driven organization leading the development of 
standards for the EPC and the EPC Network to support the use of radio 
frequency identification (RFID) in trading networks.
    Like other RFID solutions, the EPC has the ability to be read 
without a clear line-of-sight scan. Another advantage is the ability to 
update information automatically from the EPC into supply chain 
logistics applications. Warehouse and store receiving and inventory 
applications should benefit from this advantage. Benefits include 
allowing information about a particular entity to be easily read and 
transferred to computerized business applications resulting in 
increased efficiency and a reduction in data entry errors.
    I believe there is some confusion when people begin to talk about 
using RFID for track and trace of products in the supply chain. The 
idea is not to actually use the RFID chip, continually transmitting, to 
track exactly where each bag of spinach or gallon of milk is currently 
located, but rather to exploit the usability and readability of these 
tags, with a vast network of readers to monitor where the product 
travels and record a breadcrumb trail of the life of a product. 
Therefore, when it is said that we can know where the product is within 
the supply chain, what it really implies is that we can assume where 
the product is based on the last time it was read and updated to a 
computer system.
    In my testimony, when I refer to tracking the product, it is 
through computer systems and readers, which would need to be deployed 
throughout the supply chain to capture the information and update it to 
a network that can be accessed by those that need the information, 
manufacturer, wholesalers, retailers and even government agencies in 
the case of product recall. This was the idea from MIT when the EPC 
Network was conceptualized. The vision is to have a shared network, 
which knows information about products and is easily accessible to all 
that need the information.
    It comes down to 2 main issues. First, there needs to be a shared 
network which contains all the information about product flows to build 
a breadcrumb trail or pedigree of where a particular product has been 
and where it currently resides within the supply chain. Second, each 
case or package of the product has to have its own identification so 
that it can be distinguished from other cases or packages of the same 
product. The EPC code, with serialized RFID tags and the EPC Network 
are the keys to overcoming this challenge.

    Question 1.  You mentioned in your testimony that it would be too 
expensive for RFID to tag each bag of spinach. How then could you use 
RFID to trace fresh produce, given that produce is so perishable and 
the packaging quickly discarded by consumers?
    Answer 1. Thank you for the opportunity to clarify this issue. 
First I would like to say, that at readily available prices for RFID 
tags (around $.15 to $.20), it would be cost prohibitive to tag each 
bag of spinach or any other individual packages of produce. But it is 
also true that the price of tags is driven by the cost of 
manufacturing, which in turn is influenced by volume, so if higher 
volumes of product are being tagged, the prices of the tags will drop 
significantly. As RFID tagging is more widely adopted, it is 
conceivable that eventually it will be cost effective to tag most 
products at the item level.
    The tracing of fresh produce that I spoke about, is intended for 
the supply chain trading partners, suppliers and retailers. Tagging the 
product as it is processed or manufactured and using the computer 
systems and readers to build a breadcrumb trail of a product's journey 
through the supply chain and to capture the trail on a shared network, 
all the way to the store. Since it relies on the network of computers 
and readers to keep track of the product, it is neither conceivable nor 
intended to track it to individual consumers. Product in a consumer's 
home would still need to be manually verified by the consumer through 
human readable lot numbers and/or other identification on the package.
    But with improved tracking throughout the supply chain and the 
ability to follow the path of the product, the shared network can be 
used to determine where all products from a particular source went, and 
then the communication to the consumer could be much more accurate and 
timely. For example, if this level of tracking existed (even just for 
the case of bagged spinach and not each individual bag) once the source 
of the problem is discovered it could be determined the distribution 
path of that product in its entirety. If the tainted product did not 
make it into certain regions, States, cities or retail outlets, then 
the product in those areas can quickly be identified as safe and this 
information can be communicated to the consumers. The converse is also 
true, providing the capability to communicate with the consumers in 
certain regions or that shopped with certain retailers that their 
product may have an issue.

    Question 2. Although I see a lot of potential for RFID, I am a bit 
concerned about the idea of a tag on my food that can transmit 
information--I think anyone who values their privacy would be. Does the 
RFID tag tracing end at the time the product is purchased or does it 
follow the customer home? What is the distance range of the 
transmission? How can privacy concerns be addressed?
    Answer 2. In the information age, privacy, rightfully so, is always 
a concern. GS1/EPCglobal is developing a standard for deactivating or 
killing a tag at customer checkout. EPCglobal will also work with the 
member companies, suppliers and retailers, to educate consumers about 
this feature. But even without this feature, recall my explanation 
above about readers being required to access the tags, therefore the 
tracing basically ends at the time of purchase. The tags that will be 
used for tracking product through the EPC are passive tags, which have 
a read range of 4 inches to 15 feet and are not capable of transmitting 
data without being powered by a reader.

    Question 3. Given that there are a number of RFID manufacturers, 
software developers and end users, can you comment on the need for and 
progress toward interoperability of these tracking systems to ensure 
that we get value out of this technology?
    Answer 3. As I stressed in my testimony, standards and 
interoperability are critical. RFID manufactures and software 
developers recognize this need and most, if not all, are involved with 
GS1/EPCglobal which is the international standards body for the 
Electronic Product Code (EPC) and the EPC Network. GS1 is the same body 
that governs the use of bar codes and the product numbering standards 
for bar codes. I believe that industry has learned from the 
implementation of bar codes that standards and interoperability are a 
must.

          Response to Questions of Senator Enzi by Jeff Palmer

    Question 1. You indicated that you had tried to get an SBIR grant 
to assist in the development of the Timestrip technology, but were 
unsuccessful. What other barriers do you see to the development of new 
food safety technologies by small businesses?
    Answer 1. We established contact with the Ohio Department of 
Development in hopes of securing some support for the continued 
research & development of the timestrip technology. During our meeting 
with our State development representatives, we were told at the time 
that this particular technology did not meet with the definitions of 
available funding through the Ohio 3rd Frontier program, which was 
established to expand on technology advancement within Ohio. We have 
been successful in getting some tax savings for our R&D efforts. In 
terms of barriers, we do see the constant need for education and 
awareness building at least as an ongoing challenge--if not a barrier--
so that the industry can ensure that decisionmakers have a full 
understanding of the issues, needs, trends and solutions present in the 
industry. Without universal knowledge, it'll certainly be tougher to 
further technologies.

    Question 2. Given the current number of foodborne illnesses and the 
way they occur, what is the food service industry and government doing 
or not doing to contribute to reducing those statistics? What more do 
you think can be done to reduce the incidence of foodborne illness?
    Answer 2. Currently inspectors are auditing restaurants and record 
and/or fine owners for health code violations. The work being done by 
your Senate subcommittee will continue to help make food safety, and 
measures designed to prevent or control the incidence of foodborne 
illness, a top-of-mind agenda item among policymakers. Also, more and 
improved ways of training (such as DayMark's Certified Safer online 
training program) foodservice staff so that best practices are 
consistently followed and better methods are learned, forums for 
industry food safety symposia, and the offering of innovative products 
from companies like DayMark--all these things will help curb the 
problem.

         Response to Questions of Senator Enzi by John Vazzana

    Question 1. Bacteriophage sounds like a really amazing technology. 
However, I think people may be put off by the idea that their food has 
been sprayed with a virus. Are you worried about consumer acceptance of 
LMP-102? What are you doing to reach out to consumers to explain the 
use and value of your product?
    Answer 1. We are very concerned about consumer reaction to LMP-102. 
Today, most Americans believe there are good bacteria and bad bacteria. 
The challenge to Intralytix is to convince the average consumer that 
there are good viruses. We have the science on our side, but that is 
not necessarily enough. It is very interesting that the most vocal 
opponents of our technology see our technology as a quick fix for 
industry. They believe good manufacturing practices will be sufficient 
to solve the Listeria problem. Unfortunately, this is not true. We are 
taking the following steps:

    a. We are seeking large corporations to sell and market the product 
on a national basis. We need these companies to commit significant 
funds for consumer education.
    b. We are scaling up manufacturing, and intend to send samples to 
potential users in the first quarter. We have been contacted by 70 
ready to eat producers who have expressed an interest in our product. 
Most of these companies have had a serious problem with Listeria, and 
the benefits outweigh the potential customer acceptance issues. None of 
these companies are the large multinational producers.

    Question 2. What are the obstacles to further development of phages 
technology for food safety uses?
    Answer 2. The other obstacles are:

    a. Money is always a problem in the development of new products, 
but the costs to develop new phages products are relatively low.
    b. Upon approval of LMP-102, USDA took the position that any 
product treated with LMP-102 must show LMP as an ingredient on the 
label. The large producers are opposed to this. They fear groups 
opposed to LMP-102 will target their products. USDA believes LMP-102 
must be on the label because of the residual effect of the product. 
LMP-102 will dissipate over time if Listeria is not present. Because 
most ready to eat foods are refrigerated after packaging, the phage 
will still be present when the consumer opens the package. This is 
called a residual effect. As I mentioned in my presentation, phages are 
absolutely harmless, and we all consume millions of phages daily. The 
interesting fact is that if Listeria is present in the home when the 
package is opened, LMP will protect the food treated with LMP.

    Question 3. You indicate that you would prefer to receive FDA 
approval under the food contact substance notification process, rather 
than the food additive process as you did for LMP-102 because the food 
additive process takes a long time. Why are phage products currently 
considered food additives? What is the basis for this classification?
    Answer 3. Thank you again for the opportunity to present 
information to the committee about Intralytix, Inc., and the products 
we are developing at our facility in Baltimore, MD, to improve food 
safety. The first product we developed to enhance food safety, LMP-102, 
is a dilute buffered aqueous solution that includes six bacteriophage 
(phage) which are viruses that are specific to bacteria. In the case of 
LMP-102, the phage are specific to Listeria, including the pathogenic 
species Listeria monocytogenes; it took over 4 years to obtain approval 
from the Food and Drug Administration (FDA) for this product utilizing 
the food additive petition process. The next product for which we will 
be seeking clearance is called ECP-100; it targets the deadly bacteria 
E. coli O157:H7. Vegetable growers, packers and consumers cannot afford 
to wait 4 years to gain access to the public health protection ECP-100 
will provide. To accelerate clearance of our second phage-based food 
safety product, Intralytix intends to utilize the notification 
mechanism for food contact substances that Congress wisely added to the 
Federal Food, Drug, and Cosmetic Act (the act) in 1997 as section 
409(h). 21 U.S.C. 348(h). If FDA agrees to review the ECP-100 under the 
Food Contact Notification (FCN) scheme, ECP-100 could be authorized for 
sale and available to contribute to the protection of public health 
after a 120-day notification period. As part of the food contact 
notification legislation, FDA was given the authority to determine that 
the notification process is not appropriate in a particular case and to 
require that clearance be sought by the more time-
consuming petition process. Intralytix would greatly appreciate it if 
you and others on the committee expressed to FDA your support for the 
use of the notification process with regard to ECP-100.

                         DESCRIPTION OF ECP-100

    ECP-100 is a bacteriophage preparation that has been developed to 
selectively attack the deadly E. coli strain O157:H7, which was the 
contaminant in the recent nationwide spinach recall incident and 
resulted in numerous illnesses and several fatalities. As I have 
previously described to the committee, by mass, the amount of phage in 
ECP-100 is truly trivial. Indeed almost the entire mass of ECP-100 is 
water. ECP-100 is applied directly to the surface of the food 
immediately before packaging. If the food is not contaminated by E. 
coli, the phage preparation does nothing other than moisten the surface 
of the food. If E. coli is present, the phage infects the bacteria, 
multiplies and spreads to eradicate the contamination. FDA thoroughly 
documented the safety of phage preparations in the preamble to the food 
additive regulation responsive to a petition filed by Intralytix with 
regard to LMP-102. 71 Fed. Reg. 47729 (August 18, 2006). It has also 
indicated that it has no objection to GRAS (generally recognized as 
safe) Notification #198 submitted by EBI Food Safety with respect to a 
listeria phage for use on cheese.

           REGULATORY PROCEDURE FOR OBTAINING FDA'S APPROVAL

    The FCN procedure provides a streamlined approval process by which 
a manufacturer notifies FDA of its intent to market a ``food contact 
substance,'' which is defined as a substance ``intended for use as a 
component of materials used in the manufacturing, packing, packaging, 
transporting, or holding food if such use is not intended to have any 
technical effect in such food.'' See  409(h)(6) of the Act; 21 U.S.C. 
 348(h)(6). While the primary intent of this clearance option was 
intended to be, and has been tremendously successful as applied to, 
packaging materials, the term ``food contact substance'' as defined is 
much broader than just packaging.
    We believe ECP-100 is eligible for clearance under this expedited 
process because it will be used in contact with food during packing or 
packaging operations and it has no technical effect on the food. ECP-
100 does not alter the nutritional value of food; it does not alter 
taste, color or aroma; it does not texturize; it does not even preserve 
or otherwise extend the shelf life of food since it has no effect on 
spoilage organisms. For sure, ECP-100 protects food from a pathogenic 
organism, but it does so without affecting the food. ECP-100's one and 
only effect is to eradicate the deadly non-food E. coli O157:H7 
bacteria should it happen to be present. Very much like food packaging, 
ECP-100 protects food from contamination without otherwise affecting 
the food. Stated differently, its only effect is to effect safety.
    Although Intralytix expects to be the first to submit an FCN for a 
phage preparation, FDA already has a well established practice of 
utilizing the FCN process to clear antimicrobials that are much more 
broadly effective than phage. Indeed, FDA has previously agreed to rely 
on the FCN procedure to clear antimicrobials on at least nine 
occasions. In all of these cases, the antimicrobial agent is applied 
directly to the surface of food or to water in which the potentially 
contaminated food will be washed.\1\ In sum, it is our position that 
the FCN procedure is an appropriate procedure by which to request FDA's 
clearance of ECP-100.
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    \1\ For example, FCN #35 clears dimethyl dicarbonate for use as a 
microbial control agent in non-carbonated juice beverages containing up 
to and including 100 percent juice; FCN #140 clears a mixture of 
peroxyacetic acid, acetic acid, hydrogen peroxide, and 1-
hydroxyethylidene- 1, 1-diphosphonic acid (HEDP) for use as an 
antimicrobial agent for red meat carcasses; FCN #295 clears hydrogen 
peroxide for use as a component of an antimicrobial formulation for use 
on poultry carcasses, poultry parts, and whole and cut raw fruits and 
vegetables; FCN #296 clears the use of silver nitrate for use as a 
component of an antimicrobial formulation for use on poultry carcasses, 
poultry parts, and whole and cut raw fruits and vegetables; FCN #323 
clears a mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, 
1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water for use as 
an antimicrobial agent for meat and poultry carcasses; FCN #453 clears 
1,3-dibromo-5,5-dimethylhydantoin for general use as an antimicrobial 
agent in water used in poultry processing for disinfecting poultry 
carcasses and their parts and organs (essentially superceding FCNs #334 
& 357 which cleared narrower uses in poultry processing; FCN #445 
clears chlorine dioxide as an antimicrobial agent in water used in 
poultry processing and to wash fruits and vegetables that are not raw 
agricultural commodities; and FCN #450 clears a mixture of sodium 
chlorite and chlorine dioxide as an antimicrobial agent in the 
processing of red meat, red meat parts and organs, and on processed, 
comminuted, and formed meat products as a component of a dip or a 
spray.
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    Under the FCN procedure, the manufacturer provides FDA with data 
and documentation identifying the substance, its intended use, and 
information that forms the basis of the manufacturer's determination 
that the intended use of the substance is safe. After all of the 
requisite information is provided to FDA, the Agency has 120 days to 
review the materials, and if the Agency has no objections, it posts a 
notice on its Website (www.cfsan.fda.gov/dms/opafcn.html#invt) 
indicating that the FCN is ``effective'' and that the substance is 
cleared for use on food subject to any noted restrictions or 
limitations. With the experience gained by both Intralytix and FDA's 
Center for Food Safety and Applied Nutrition, we are optimistic that 
120 days will be more than adequate for FDA to evaluate Intralytix' 
ECP-100 submission.

    FDA SHOULD BE ENCOURAGED TO FAVORABLY REVIEW THE FCN FOR ECP-100

    E. coli O157:H7 is a deadly bacteria that has already claimed the 
lives of many innocent people. ECP-100 was developed specifically to 
target E. coli O157:H7, and it is not only highly effective, but also 
exceedingly safe because phage are effective only against bacteria. Its 
use on food will save lives, and as such, its safety and proposed use 
on food should be reviewed as soon as possible by FDA. Since the FCN 
procedure is the least time-consuming avenue for obtaining the Agency's 
approval, and since many other antimicrobial substances already have 
been reviewed by FDA via the FCN procedure, your encouragement that FDA 
favorably consider our FCN submission so as to permit our Nation's food 
supply to be protected from the deadly E. coli O157:H7 as soon as 
possible will be greatly appreciated.

    [Whereupon, at 5:25 p.m., the hearing was adjourned.]

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