[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
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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
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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.]