[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
HEARING TO REVIEW THE LEGAL AND
TECHNOLOGICAL CAPACITY FOR FULL
TRACEABILITY IN FRESH PRODUCE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON
HORTICULTURE AND ORGANIC AGRICULTURE
OF THE
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
WEDNESDAY, JULY 30, 2008
__________
Serial No. 110-45
Printed for the use of the Committee on Agriculture
agriculture.house.gov
----------
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COMMITTEE ON AGRICULTURE
COLLIN C. PETERSON, Minnesota, Chairman
TIM HOLDEN, Pennsylvania, BOB GOODLATTE, Virginia, Ranking
Vice Chairman Minority Member
MIKE McINTYRE, North Carolina TERRY EVERETT, Alabama
BOB ETHERIDGE, North Carolina FRANK D. LUCAS, Oklahoma
LEONARD L. BOSWELL, Iowa JERRY MORAN, Kansas
JOE BACA, California ROBIN HAYES, North Carolina
DENNIS A. CARDOZA, California TIMOTHY V. JOHNSON, Illinois
DAVID SCOTT, Georgia SAM GRAVES, Missouri
JIM MARSHALL, Georgia MIKE ROGERS, Alabama
STEPHANIE HERSETH SANDLIN, South STEVE KING, Iowa
Dakota MARILYN N. MUSGRAVE, Colorado
HENRY CUELLAR, Texas RANDY NEUGEBAUER, Texas
JIM COSTA, California CHARLES W. BOUSTANY, Jr.,
JOHN T. SALAZAR, Colorado Louisiana
BRAD ELLSWORTH, Indiana JOHN R. ``RANDY'' KUHL, Jr., New
NANCY E. BOYDA, Kansas York
ZACHARY T. SPACE, Ohio VIRGINIA FOXX, North Carolina
TIMOTHY J. WALZ, Minnesota K. MICHAEL CONAWAY, Texas
KIRSTEN E. GILLIBRAND, New York JEFF FORTENBERRY, Nebraska
STEVE KAGEN, Wisconsin JEAN SCHMIDT, Ohio
EARL POMEROY, North Dakota ADRIAN SMITH, Nebraska
LINCOLN DAVIS, Tennessee TIM WALBERG, Michigan
JOHN BARROW, Georgia BOB LATTA, Ohio
NICK LAMPSON, Texas
JOE DONNELLY, Indiana
TIM MAHONEY, Florida
TRAVIS W. CHILDERS, Mississippi
______
Professional Staff
Robert L. Larew, Chief of Staff
Andrew W. Baker, Chief Counsel
April Slayton, Communications Director
William E. O'Conner, Jr., Minority Staff Director
______
Subcommittee on Horticulture and Organic Agriculture
DENNIS A. CARDOZA, California, Chairman
BOB ETHERIDGE, North Carolina RANDY NEUGEBAUER, Texas, Ranking
LINCOLN DAVIS, Tennessee Minority Member
TIM MAHONEY, Florida JOHN R. ``RANDY'' KUHL, Jr., New
JOHN BARROW, Georgia York
KIRSTEN E. GILLIBRAND, New York VIRGINIA FOXX, North Carolina
TRAVIS W. CHILDERS, Mississippi K. MICHAEL CONAWAY, Texas
BOB LATTA, Ohio
Keith Jones, Subcommittee Staff Director
(ii)
C O N T E N T S
----------
Page
Cardoza, Hon. Dennis A., a Representative in Congress from
California, opening statement.................................. 1
Prepared statement........................................... 3
Neugebauer, Hon. Randy, a Representative in Congress from Texas,
opening statement.............................................. 4
Peterson, Hon. Collin C., a Representative in Congress from
Minnesota, prepared statement.................................. 6
Witnesses
DeGette, Hon. Diana, a Representative in Congress from Colorado.. 6
Prepared statement........................................... 8
Putnam, Hon. Adam H., a Representative in Congress from Florida.. 10
Prepared statement........................................... 12
Acheson, M.D., F.R.C.P., David W.K., Associate Commissioner for
Food Protection, Food and Drug Administration, U.S. Department
of Health and Human Services, Washington, D.C.................. 18
Prepared statement........................................... 21
King, D.V.M., Lonnie J., Director, National Center for Zoonotic,
Vector-borne, and Enteric Diseases, Centers for Disease Control
and Prevention, U.S. Department of Health and Human Services,
Washington, D.C................................................ 28
Prepared statement........................................... 30
Osterholm Ph.D., M.P.H., Michael T., Director, Center for
Infectious Disease Research and Policy; Director, Minnesota
Center of Excellence for Influenza Research and Surveillance;
Professor and Adjunct Professor, Division of Environmental
Health Sciences, School of Public Health, Medical School,
University of Minnesota, Minneapolis, MN....................... 53
Prepared statement........................................... 57
DiMare, Anthony J., Vice President, DiMare Homestead Inc., DiMare
Ruskin Inc., and DiMare Johns Island Inc.; Member, Board of
Directors, Florida Fruit & Vegetable Association; President,
Florida Tomato Exchange; Member, Board of Directors, United
Fresh Produce Association, Ruskin, FL.......................... 62
Prepared statement........................................... 64
Giclas, Henry L. ``Hank'', Vice President--Strategic Planning,
Science and Technology, Western Growers Association, Irvine, CA 65
Prepared statement........................................... 67
Silbermann, C.A.E., Bryan, President, Produce Marketing
Association, Newark, DE........................................ 71
Prepared statement........................................... 73
Stenzel, Thomas E., President and CEO, United Fresh Produce
Association, Washington, D.C................................... 75
Prepared statement........................................... 77
Gorny, Ph.D., James R., Executive Director, Postharvest
Technology Research & Information Center, University of
California-Davis, Davis, CA.................................... 93
Prepared statement........................................... 95
Halloran, Jean, Director, Food Policy Initiatives, Consumers
Union, Yonkers, NY............................................. 98
Prepared statement........................................... 99
Submitted Statement
Driskill, Jesse, President, Fresh Produce Association of the
Americas....................................................... 105
HEARING TO REVIEW THE LEGAL AND
TECHNOLOGICAL CAPACITY FOR FULL
TRACEABILITY IN FRESH PRODUCE
----------
WEDNESDAY, JULY 30, 2008
House of Representatives,
Subcommittee on Horticulture and Organic
Agriculture,
Committee on Agriculture,
Washington, D.C.
The Subcommittee met, pursuant to call, at 1:33 p.m., in
Room 1300 of the Longworth House Office Building, Hon. Dennis
A. Cardoza [Chairman of the Subcommittee] presiding.
Members present: Representatives Cardoza, Etheridge,
Mahoney, Childers, Costa, Neugebauer, and Foxx.
Staff present: Nathan Fretz, Alejandra Gonzalez-Arias,
Tyler Jameson, Keith Jones, April Slayton, John Goldberg, Pam
Miller, Pete Thomson, and Jamie Weyer.
OPENING STATEMENT OF HON. DENNIS A. CARDOZA, A REPRESENTATIVE
IN CONGRESS FROM CALIFORNIA
The Chairman. We will call this hearing to order. I would
like to welcome everyone in the audience and all our panelists.
This hearing of the Subcommittee on Horticulture and Organic
Agriculture is to review the legal and technological capacity
for full traceability in fresh produce, and it will now come to
order. What we will do is follow the agenda. We are going to
start with opening statements by myself and my Ranking Member,
Mr. Neugebauer of Texas, and then we will proceed to our first
panel. We have a very distinguished panel with us today. I want
to start by thanking you all for attending this hearing and
taking your very busy time to be here with us.
This hearing, as I said, is on the traceability of fresh
produce. We are holding this hearing in the midst of one of the
most costly and disruptive food illness outbreaks in recent
memory. Since April, almost 1,300 Americans in 42 states and
the District of Columbia have been infected with Salmonella
Saintpaul. This outbreak was first identified May 21 by the New
Mexico Department of Health. As the number of cases mounted,
state officials alerted the CDC of the outbreak. Meanwhile, but
unbeknownst to New Mexico officials, authorities in Texas also
alerted the CDC that similar cases had emerged in their state.
The investigation faltered almost from the beginning as
health officials in both states began asking patients what they
ate before they became ill. They used standard questionnaires
which list the major but not all food items that the patients
may have consumed. The questionnaires listed peppers but not
specifically jalapeno peppers, a food commonly consumed in the
Southwest. But a number of those infected remembered eating
tomatoes, so with little else to go on, the FDA issued a
nationwide warning linking consumption of certain raw red
tomatoes to the outbreak of Salmonella Saintpaul.
Hundreds of miles away, however, a different conclusion was
being reached in Minnesota. A cluster of Salmonella Saintpaul
cases emerged in connection with a local Mexican restaurant.
Among the customers and employees sickened, jalapenos were the
common thread. So over 2 months after the first outbreak began,
over 1,000 illnesses reported and hundreds of millions of
dollars in losses to tomato farmers later, jalapeno peppers
were implicated by FDA as the source of the current outbreak.
This missed connection between jalapenos as the ultimate source
of the outbreak is extremely troubling. Clearly, serious flaws
continue to exist in the methodology used by some states to
collect primary epidemiological data. Furthermore, the process
used by CDC to verify and redefine the collected data calls
into serious question the effectiveness of communications
between states, the CDC and the FDA. I want to note for the
record that both Texas and New Mexico Departments of Health
were invited to serve here as hearing witnesses but
unfortunately both declined due to scheduling conflicts.
Given the FDA's reversal on the source of the outbreak, I
am extremely interested today to hear from FDA and CDC
regarding the performance of the survey instruments, the
methodology employed in interviewing the patients and the
sampling protocols. Frankly, I would just like to hear what
went wrong. We all sat here a little more than a year ago and
had nearly the same conversation about spinach. Was nothing
learned from that experience? Were we any better prepared this
time around?
What was particularly troubling to me as I watched the
Salmonella investigation drag on and the illnesses and losses
mount is the government's continued inability to effectively
and accurately trace products from the retail level back
through the supply chain to its origin. Some food safety
experts that we will hear from today assert that these
traceback efforts have been hampered by a lack of uniform
record-keeping or product descriptions or that traceback
requirements within the 2002 Bioterrorism Act have been both
poorly implemented and poorly enforced by FDA. But industry
officials on the other hand claim that traceback efforts in
this current outbreak have worked well and as expected.
As we can see, there is a disagreement, but, hopefully
today we can stop the rhetoric that has been circulating around
this investigation and start working on a solution because
there is no disagreement about one thing: the status quo simply
cannot and must not continue. Poor handling of this outbreak
has confused consumers, damaged producers and led to just mass
confusion in the public. You could describe our current food
safety system as outbreak roulette: one spin of the outbreak
wheel and your industry may be bankrupt, your loved ones
sickened. This is unacceptable and we need to take steps to
improve the response of our government and industry to
foodborne illness outbreaks. We must stop being reactive and
wasting precious time pointing fingers as soon as an outbreak
occurs.
In the House-passed version of the farm bill, I and several
of us tried to take steps in this direction by allowing
marketing orders to include food safety protocols. I strongly
supported this provision and with the hope that the growers
could fill the void of food safety while Congress debated the
merits of overhauling our current tracking systems because
tracking only solves the mystery after the health problem has
broken out. That is always helpful but the marketing order
approach helps improve grower and shipper practices before
consumption and before a possible outbreak. Unfortunately, that
provision lost out in a strange dance we call around here the
conference committee process, and as such, the status quo for
food safety remains in place.
But strengthening marketing orders and cultural practices
are only part of the story. Today we are here to take a closer
look at the legal and technological capacity for traceability
in fresh produce. We have four very distinguished panels to
hear from today. This hearing is purposely structured to
include Members of Congress, and we have two of the best here
before us from different parts of the country. It includes
agencies, industry, scientists as well as consumer interests.
We all have a role to play in re-examining and reshaping this
country's food safety system.
[The prepared statement of Mr. Cardoza follows:]
Prepared Statement of Hon. Dennis A. Cardoza, a Representative in
Congress From California
Thank you all for attending this hearing and taking time from your
very busy schedules to testify today on traceability in fresh produce.
We are holding this hearing in the midst of one of the most costly
and disruptive food illness outbreaks in recent memory.
Since April, almost 1,300 Americans in 42 states and the District
of Columbia have been infected with Salmonella Saintpaul.
This outbreak was first identified May 21 by the New Mexico
Department of Health. As the number of cases mounted, state officials
alerted the CDC of the outbreak. Meanwhile, but unbeknownst to New
Mexico officials, authorities in Texas also alerted the CDC that
similar cases had emerged in their state.
The investigation faltered almost from the beginning as health
officials in both states began asking patients what they ate before
they became ill. They used standard questionnaires which list the
major--but NOT all--food items that patients may have consumed.
The questionnaire listed peppers, but not specifically jalapeno
peppers--a food commonly consumed in the Southwest. But a number of
those affected remembered eating tomatoes. So with little else to go
on, FDA issued a nationwide warning linking consumption of certain raw
red tomatoes to the outbreak of Salmonella Saintpaul.
Hundreds of miles away, however, a different conclusion was being
reached in Minnesota. A cluster of Salmonella Saintpaul cases emerged
in connection with a local Mexican restaurant. Among the customers and
employees sickened, jalapenos were the common thread.
So over TWO MONTHS after the first outbreak began, and over a
thousand illnesses reported and hundreds of millions in losses to
tomato farmers later, jalapeno peppers were implicated by FDA as the
source of the current outbreak.
This missed connection between jalapenos as the ultimate source of
the outbreak is extremely troubling.
Clearly serious flaws continue to exist in the methodology used by
some states to collect primary epidemiological data. Furthermore, the
process used by the CDC to verify and refine the collected data calls
into serious question the effectiveness of communications between the
states, CDC and FDA.
I want to note for the record that both the Texas and New Mexico
Department of Health were invited to serve as hearing witnesses, but
unfortunately both declined due to scheduling conflicts.
Given the FDA's reversal on the source of the outbreak, I am
extremely interested to hear from FDA and CDC regarding the performance
of the survey instruments, the methodology employed in interviewing the
patients and the sampling protocols.
Frankly, I would just like to hear what in the heck went wrong??
We all sat here, a little more than a year ago and had nearly the
SAME conversation about spinach. Was nothing learned from that
experience? Were we any better prepared this time?
What was particularly troubling to me as I watched Salmonella
investigation drag on and on and the illnesses and losses mount, is the
Federal Government's continued inability to effectively and accurately
trace products from the retail level back through the supply chain to
its origin.
Some food safety experts that we will hear from today assert that
these traceback efforts have been hampered by a lack of uniform record-
keeping or product descriptions. Or that traceback requirements within
the 2002 Bioterrorism Act have been both poorly implemented and poorly
enforced by FDA.
But industry officials on the other hand claim traceback efforts in
this current outbreak have worked well and as expected.
As we can see, there is disagreement but hopefully today we can
stop the rhetoric that has been circulating around this investigation
and start working on solutions. Because there is no disagreement that
the status quo can not and MUST NOT continue.
The poor handling of this outbreak has confused consumers and
damaged producers. You could describe our current food safety system as
``outbreak roulette''. One spin of the outbreak wheel and your industry
may be bankrupt, your loved ones sickened. This is unacceptable, and we
need to take steps to improve the response of government and industry
to foodborne illness outbreaks.
We must stop being reactive and waste precious time pointing
fingers as soon as an outbreak occurs. The House-passed version of the
farm bill tried to take a step in this direction by allowing marketing
orders to include food safety protocols.
I strongly supported this provision, with the hope that growers
could fill the void of food safety while Congress debated the merits of
overhauling our current tracking systems. Because tracking only solves
the mystery after a health problem has broken out. That's helpful, but
the marketing order approach helps improve grower and shipper practices
before consumption and before a possible outbreak.
Unfortunately, that provision lost out in the strange dance we
called ``Conference''. And, as such, the status quo for food safety
remains in place.
But strengthening marketing orders and cultural practices are only
part of the story. Today we are here to take a closer look at the legal
and technological capacity for traceability in fresh produce, we have
four very distinguished panels to hear from today. This hearing is
purposely structured to include Members of Congress, agencies,
industry, scientists and consumer interests.
We all have a role to play in re-examining and reshaping this
country's food safety system.
With that, I now yield time to Ranking Member Neugebauer for his
opening statement.
The Chairman. With that, I would now like to yield the
floor to my Ranking Member, Mr. Neugebauer, for his opening
statement.
OPENING STATEMENT OF HON. RANDY NEUGEBAUER, A REPRESENTATIVE IN
CONGRESS FROM TEXAS
Mr. Neugebauer. I thank you, Chairman Cardoza, and I
appreciate you calling this hearing. Obviously this is a
subject that a lot of people have a lot of interest in. We see
a lot of folks here, and it is an important subject as well,
and I appreciate the opportunity to review the recent events
with the Salmonella outbreak that has been tentatively
associated with fresh vegetables.
This was a tragic event. It is one that we hope that we can
work together both with the industry and this Committee and the
government to come up with ways in the future to prevent these
kinds of episodes from happening. One of the things we do know
is by and large Americans have enjoyed the safest food in the
world. We need to continue to work on that and make sure that
process happens. Can we get better? I think we must. I think
the real fine line that we are all going to be walking here is,
are there things that we can do, for example, on traceback to
ensure that when we do identify that there is a problem that we
can quickly resolve that with the least amount of disruption to
the marketplace and to the consumers. I think it is going to be
a cooperative effort because no one knows more about the supply
chain than the individual companies and producers themselves.
We must integrate the information that they have along with
what the regulatory entities in charge of food safety can
provide for us and work together to look at the overall system
and say where are the weak links in this process so that we can
indeed make them stronger. And certainly the traceback is one
of those issues that we have had now, I believe, two different
jalapeno peppers that now have been identified as the potential
source for that.
But what we do know, as the Chairman alluded to earlier,
that tomatoes were originally named as the culprit and so we
did a widespread ban and took millions and millions of dollars
worth, maybe even billions of dollars worth of produce off the
market as a preventative measure. As it turns out at this
particular point in time, it was not necessary to do that. And
so I think that also brings up the other issue as we go down
this road of making sure that American people have safe food
and the processes that we might implement and the policies that
we may make. What we also don't want to do is cause unnecessary
processes that drive up the cost of food to the ultimate
consumer. We have already seen a fairly substantial increase in
food prices for Americans. Their gasoline prices are
increasing. Their food prices are increasing. And so what we
will make sense of as we listen to the testimony of those that
have interest and have knowledge about this, we are going to be
looking for common sense solutions of using the technology that
we have available to us today. We will be looking at some of
the different places in the supply and the food chain where the
cases of contamination are more likely to happen and see what
we can do in order to make that process better.
So I appreciate the Chairman holding this hearing. I think
it is going to be very important. I think the American people
are anxious to see what we can and are going to do about this.
With that, Mr. Chairman, I look forward to hearing from our
panel today.
The Chairman. Very good. I thank the gentleman from Texas.
He has been a great partner in working on the issues in this
Committee. I would like to also say that I wholeheartedly
concur with him. I should have made this point at the outset of
my opening statement as well, that I believe that the produce
and the food that the farmers of this country grow and produce
for consumption is the safest in the world. This isn't a
question about indicting all of our farmers. It is a question
of making sure that when we do have a problem, that we can
figure out how to correct that problem and that we continue to
strive for the safest possible food that we can produce. And so
I thank the Ranking Member for making that point.
Now, we are going to recognize, if they come in, Mr.
Peterson and Mr. Goodlatte as the ex officio Members, Mr.
Peterson being the Chairman and Mr. Goodlatte being the Ranking
Member of the full Committee, if they show up later throughout
the hearing, and of course, they can participate as well. The
chair would request that other Members submit their opening
statements for the record so the witnesses may begin their
testimony and we ensure there is ample time for questions.
[The prepared statement of Mr. Peterson follows:]
Prepared Statement of Hon. Collin C. Peterson, a Representative in
Congress From Minnesota
Thank you, Chairman Cardoza for recognizing me to speak and for
holding this hearing on this serious issue. As we have watched the
situation involving cases of Salmonella Saintpaul unfold over the past
several months, many of us in Congress have become more and more
concerned about the ability and agility of government and industry to
respond to foodborne disease outbreaks. I also want to thank the
witnesses who have joined us today. There are some serious questions
that need to be asked, and their answers will help us better understand
what needs to be done to respond better to the next outbreak.
There are several issues related to the current outbreak that this
and other panels in Congress will be taking a close look at. First is
the information provided by different states to the CDC during the
effort to identify the cause of the outbreak. Information from New
Mexico and Texas suggested tomatoes as a culprit, but in Minnesota,
officials found a cluster of illnesses that started after suspect
tomatoes were removed from the menu. Now, the source appears to be
jalapeno peppers, but some people question how sure FDA can be about
this source after first implicating, then exonerating another.
Beyond these serious questions about availability and quality of
information received by CDC and FDA from the states, there are
questions about why it took so long to rule out tomatoes as the source.
It is vitally important both for consumer confidence and public health
purposes that we can identify the source of food products quickly and
effectively. This is particularly important when we're trying to stop
the spread of a foodborne disease outbreak.
This is a serious problem that we seem to come back to after every
serious outbreak. Traceability must be a priority--it is critical not
only to ensure public health, our top priority, but also to ensure that
consumers can feel confident that when there is a problem with a food
product, we can quickly find the source and prevent additional
illnesses.
Looking at the current outbreak of Salmonella Saintpaul and other
recent incidents, there is plenty of blame to go around--government and
industry have made mistakes and have failed to address the flaws that
have been highlighted in recent outbreaks. But what is more important
is that we work together to find solutions that will help government
and industry do a better job next time. I hope that today's hearing
will be a step in that direction.
Chairman Cardoza, thank you again for holding this timely and
important hearing, and I look forward to the testimony from the
witnesses.
We are going to start out with two of the best, as I said,
Congresswoman Diana DeGette from Colorado and Congressman
Putnam from Florida. Thank you both for being here. You have
been leaders in this question, and the floor, Ms. DeGette, is
yours for your statement.
STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN CONGRESS
FROM COLORADO
Ms. DeGette. Thank you very much, Mr. Chairman and Members
of the Committee. My urban constituents were a little bemused
when they found out that I was testifying in front of the
Agriculture Committee but I reminded them that they are all
consumers too, and certainly we have an important topic today
with the recent foodborne disease outbreaks that we have seen.
Mr. Chairman, you mentioned in your opening remarks about
deja vu all over again with the spinach outbreak and now the
tomato/jalapeno outbreak, which we feel the same way in the
Energy and Commerce Committee where we have had a series of
food safety hearings. While it is absolutely true that we have
the safest food growing and distribution system in the world,
we can still do better and I think that is all of our hope as
we fashion legislation going into the fall. This is an
important hearing and it is an important topic and I think that
we can well address it.
As you may know, I have been working on traceback
legislation for almost 6 years now. H.R. 3485, the TRACE Act,
would require the USDA and the FDA to set up a food product
traceability system that would track foods all along the supply
chain. Now, obviously our primary focus needs to be on
continuing to build quality into the system and avoid outbreaks
all together. Being able to fully trace tainted food is not the
ideal situation because by then the tainted food is in the
stores and in the households and on the plates of Americans.
But the fact remains that we also must have procedures in place
to deal with an emergency to get food off store shelves
quickly, to avoid the kind of mass panic we saw in the most
recent outbreak of Salmonella and most importantly to prevent
more people from getting sick. If we did, businesses, Mr.
Neugebauer so aptly pointed out, would save millions of dollars
in avoiding overreaching recalls as well.
To a certain extent, we have limited traceability right
now. Most food companies know their own suppliers and customers
and the Bioterrorism Act requires companies to have the ability
to trace one step up and one step back. While this is a good
start, it is not enough because it does not fully trace food
from field to fork, as we have seen all too painfully in the
most recent outbreak. In that case, the FDA sifted through
boxes and boxes of paper to determine who the suppliers and
customers were. In the meantime, over 14 weeks went by and over
1,200 people got sick, not to mention the endless news stories,
tons and tons of spoiled food and entire industries destroyed
unnecessarily. This one outbreak has shown us that the system
is agonizingly slow and simply incapable of keeping up with a
globalized food distribution system. And it is not over yet
because despite the discovery of a tainted jalapeno pepper
recently and now another one just this week in my home State of
Colorado, the FDA cannot say with any certainty whether or not
tomatoes were ever to blame and it still does not know where
the contamination occurred. Given the new warning that
consumers should not eat jalapenos despite their origin, it is
obvious that we still have no idea where the tainted peppers
came from or were distributed.
Mr. Chairman, there really is a better way. As I mentioned
before, H.R. 3485 would require the USDA and FDA to set up a
system to trace foods throughout the supply chain. Not only is
this legislation technologically feasible, it is absolutely
critical. Now, I am not saying that the government should be in
the business of mandating certain technology. There are many
ways of electronically tracking foods and tracking is already
being done by some companies and some industries all over the
world using labels, barcoding, wireless RFID readers, lasers
and even GPS. What I do think is that the government's role is
to standardize and coordinate. What we need is an integrated
system rather than a patchwork of incomplete and incompatible
traceability systems. Because of the valuable public health and
economic benefits of full traceability, I think that the
Federal Government must mandate these systems.
Now, Mr. Chairman, I will put the rest of my statement in
the record but let me say and let me be on record, I don't want
to create a system that is overly burdensome for business or to
put a whole new set of costly regulations in place that would
burden food distributors or small farmers. Quite the contrary.
In fact, right now I am being approached by businesses from
around the country that tell me they want to get going right
now because they want to avoid the kinds of losses that we saw
in the tomato industry just with this latest outbreak. If you
meet with the FDA, if you meet with the business groups, you
know we do have the technology in place.
In the Energy and Commerce Committee, Chairman Dingell has
put together a Chairman's markup of a food safety bill. This
bill does not yet include traceability but I would hope as we
move forward in that Committee as well as in the other
Committees of jurisdiction, we would seriously look at having
our Federal Government put together traceability systems that
are interoperable and that can help us trace from field to fork
where this food came from.
So, Mr. Chairman, I look forward to answering the questions
of the Committee, and with that, I suppose I will yield to my
distinguished colleague. Thank you.
[The prepared statement of Ms. DeGette follows:]
Prepared Statement of Hon. Diana DeGette, a Representative in Congress
From Colorado
Thank you, Chairman Cardoza and Members of the Subcommittee. I
would like to start by thanking you for giving me the opportunity to
testify before this distinguished Subcommittee.
I also want to commend you for taking up such an important topic at
such a critical time. The events over the past few months have
crystallized the need for a comprehensive food traceability system in
this country, particularly with regard to fresh produce.
I have been working on traceback legislation for about 6 years.
H.R. 3485, the ``TRACE Act,'' would require the USDA and FDA to set up
a food product traceability system that would track foods at all points
along the supply chain.
In my opinion we cannot begin to address updating our nation's food
safety laws without looking at the ability to track our food.
Obviously our primary focus needs to be on building quality into
the system and avoiding outbreaks altogether. Being able to fully trace
tainted food is not an ideal situation.
But the fact remains that we must have procedures in place to deal
with an emergency, to get food off store shelves quickly, avoid the
kind of mass panic we saw in this most recent outbreak of Salmonella,
and most importantly prevent more people from getting sick.
To a certain extent, we have limited product traceability right
now. Most food companies know their own suppliers and customers, and in
fact the Bioterrorism Act requires companies to have the ability to
trace one step up and one step back. While this is a good start, it is
not enough, and we need to find out whether these requirements are even
being enforced. And I think we can all agree that whatever traceability
system that exists today certainly did not work in the tomato/pepper
Salmonella outbreak.
In this case, the FDA sifted through boxes and boxes of paper
records to determine suppliers and customers. In the meantime, over 14
weeks went by and over 1,200 people got sick--not to mention the
endless news stories, tons and tons of spoiled food, and entire
industries damaged unnecessarily.
It has become clear that this system is agonizingly slow and simply
incapable of keeping up with a globalized food distribution system.
And it's not over. Despite the discovery of a tainted jalapeno
pepper recently, the FDA cannot say with any certainty whether or not
tomatoes were ever to blame, and it still does not know where the
contamination occurred. And given the new warning that consumers should
not eat jalapenos, despite their origin, it's obvious that they have no
idea where the tainted peppers were distributed.
Mr. Chairman, there is a better way.
As I mentioned before, H.R. 3485 would require the USDA and FDA to
set up a system to trace foods throughout the supply chain. Not only is
this legislation technologically feasible and cost effective, but it's
absolutely critical.
I am not saying that we should be in the business of mandating
certain technology. There is a whole host of ways to electronically
track foods, and it is already being done by certain companies and
certain industries all over the world, using labels, bar coding,
wireless RFID readers, lasers, even GPS.
Where I think the government can be useful is to help coordinate.
What we need is an integrated system, rather than a patchwork of
different traceability systems. And because of the valuable public
health and economic benefits to full traceability, I feel the FDA and
USDA have a responsibility to help.
We must ensure systems are interoperable and can talk to each
other, so food can be continually tracked along the distribution
system, especially when there is a transfer of ownership.
What I don't want to do is create a system that is overly
burdensome for business, or to put a whole new set of costly
regulations on our nation's food distributors or small farmers. Quite
the contrary. In fact, I am being approached by businesses from across
the country that want to get going now.
Full traceability is going to be good for business. IBM Consulting
has written a report that recommends its clients develop full
traceability to improve consumer confidence, which has eroded in recent
years due to recall after recall.
As we have seen in the latest Salmonella outbreak, as well as
previous recalls in spinach and other products, when contamination
happens at even a single facility, an entire industry can be
devastated. Despite the fact that nearly all spinach was harmless in
2006, and the vast majority of jalapenos are probably safe now, and the
distinct possibility that not a single tomato was ever contaminated,
growers and distributors suffered catastrophic losses.
Nationwide, blanket recalls and generalized consumer warnings with
no connection to actual distribution chains create mass panic, causing
customers to avoid certain products and altogether. In an industry
where brand preservation is everything, we can't allow this to
continue.
A comprehensive traceback program would allow for targeted recalls;
if an outbreak occurs we will know exactly what lots were potentially
contaminated instead of targeting the entire universe of products like
we did with spinach, tomatoes, and peppers.
We can find out within seconds where tainted food was sent and
where it originated, and have an orderly process of notifying affected
consumers and pulling products from shelves. Therefore the 99.9% of
businesses selling perfectly safe food from perfectly sanitary
facilities will be protected against contamination that occurs
elsewhere.
And electronic traceability has benefits to business that go beyond
brand preservation and insurance against recalls caused by other parts
of the market. Traceability brings better inventory control and
supplier/customer monitoring practices, and is a good marketing
technique to attract and retain customers.
To be sure, the outbreaks of foodborne illnesses in recent years
have spurned action in the private sector. Traceability systems are
being implemented by industries as diverse as fresh produce and
alcohol, from processed food to fast food, just to name a few.
But the USDA and FDA need to play a key role. My legislation will
build upon this important work that is already happening by linking all
of the pieces together without being overly burdensome.
Mr. Chairman, we cannot waste any more time postponing food safety
reform. Why wait for the next outbreak, the next 1,200 illnesses, the
next mass panic that devastates our farmers, before we act?
There is much to be done. It is time to create a unitary food
agency, so 12 different agencies aren't sharing the jurisdiction yet
passing the buck. We need to provide the USDA and FDA with mandatory
recall authority. And we have to start rebuilding the FDA and USDA to
be able to better operate in a 21st Century, globalized food
distribution system.
But the latest Salmonella outbreak has shown that food traceability
must be a part of the mix. Consumers want to know where there food is
coming from, businesses need insurance against risk, and as
policymakers our first priority must be public health.
Thank you so much for the opportunity of appearing before this
Subcommittee.
The Chairman. Thank you, Ms. DeGette.
Mr. Putnam.
STATEMENT OF HON. ADAM H. PUTNAM, A REPRESENTATIVE IN CONGRESS
FROM FLORIDA
Mr. Putnam. Thank you very much, Mr. Chairman. It is great
to be back in the Agriculture Committee. I was explaining to my
colleague here that when I arrived, I was the next to bottom
chair here at the kids' table embarking on that farm bill
discussion back in 2001.
I appreciate the opportunity to be before this Subcommittee
on which I used to serve, and like you, Mr. Chairman and Mr.
Neugebauer, Ranking Member, I am very interested in hearing
what the other panels have to say in terms of what went wrong.
Clearly there was a very serious breakdown and we need to
improve the system as we move forward, recognizing that
Americans are still blessed with the safest, cheapest and most
abundant food supply.
I want to spend just a little bit of time talking about the
recent outbreak of Salmonella and then talking about a bill
that I have filed with Mr. Costa, who is also a Member of the
Committee, from California and the work that we have done based
on the work that each of our states have done, California and
Florida, to really produce a seamless food safety net,
especially for the produce aspect of agriculture.
The outbreak of Salmonella Saintpaul, which is now
estimated to have impacted over 1,300 people in 43 states, not
only called into question the integrity of the system designed
to protect our food supply and the security and safety of our
consumers, but also significant disruptions to the network that
produces those agricultural goods. The aftermath, the damage
that was caused to the early publicly suspected commodities
though lasts far longer than the impact of this illness. There
is permanent damage done to the markets, which is something
that is an important aspect of this discussion, that as a
result of early errors in the investigation, there were early
public statements that inaccurately identified particular
commodities. That is damage that transcends this discussion,
that transcends the illness and is permanent to those producers
and to the market brand or image of those crops. This incident
demonstrated that our governing food safety authorities are
outdated. They must be reformed and enhanced to reflect modern
scientific standards and industry practices as well as sound
and strong policies implemented to prevent future food
contamination.
The bill that Mr. Costa and I have introduced is called the
Safe Food Enforcement, Assessment, Standards and Targeting Act,
or the Safe FEAST Act, H.R. 5904, we believe it would help to
provide the highest level of food safety protection both for
goods produced domestically and those that are imported from
abroad. As I said earlier, it is based on the success from our
laboratories of democracy in the states where this has been
tried real-time, and implemented, and it is functioning well.
The comprehensive measure would modernize our food safety
network and put into place new food safety standards all along
the food chain from farm harvest, processing, packing and
distribution, to the retail outlet and finally to the consumer
to identify and prevent potential sources of foodborne illness.
The bill calls for balanced, science-based food safety
requirements for farm and food companies, domestic and abroad,
implementing the principles of risk assessment and risk
management, to improve safeguards in our food supply as well as
mitigate unwarranted market disruptions to agricultural
suppliers.
To ensure the highest level of food safety for the American
consumer, the bill requires all domestic and foreign food
companies selling food in the United States to conduct a food
safety risk analysis that identifies potential sources of
contamination, outlines appropriate food safety controls and
requires verification that those controls that are implemented
are adequate to address those risks of foodborne contamination.
Similarly, to ensure that food products coming into the
United States from international sources are safe, those
imported goods would also have to adhere to the same safety and
quality standards as set by the FDA for what is grown in the
United States. It specifically establishes new standards for
fresh produce, putting into place for the first time mandatory
food safety regulations for high-risk produce and voluntary
good agricultural practice guidelines for the safe production
of all fruits and vegetables.
For those produce items that are deemed to pose the highest
risk by FDA, the bill calls for the issuance of mandatory
science-based regulations to prevent the occurrence of
foodborne illness at all potential points of hazard from the
farm to the table. It calls on FDA to establish standards for
the safe production, harvesting and packaging of those types of
fruits and vegetables for which the Secretary has determined
are necessary to minimize the risk of serious adverse health
consequences.
These food safety initiatives have the support of the
produce industry. I think that that is an important piece of
this. This is not something that is being foisted on an
industry that is either technologically incapable of for
various reasons in the supply chain or the production of these
commodities are unable to implement these new regulations. It
has the support of the industry, which has a stake in ensuring
the safety and security of their food products.
This issue, the spinach issue, other issues prove the
growers, the farmers have as much at stake as anyone in making
sure this doesn't happen again. I mean, your public health
officials and your farmers are of one mind in being committed
to prevent this from being a future problem. It is in no one's
interest to continue to undermine public confidence in the
safety and sanctity of the nation's food supply.
This bill strengthens the relationship between Federal,
state and foreign government agencies by increasing cooperation
to better control food safety threats, calling on the expertise
and resources of these partners to respond to the food safety
occurrences in a more timely and efficient manner.
This is the second point that I would like to make. Just as
our bill, which was drafted long before the Saintpaul
Salmonella outbreak, built on the success at the state level,
one of the failures, frankly, in this recent outbreak was the
breakdown in communication between not only industry experts
and public health officials but state public health officials,
people who are charged by their state legislatures under state
statute with implementing food safety guidelines for their
states. I don't believe that in this investigation we fully
utilized all the resources that were out there in government,
in public health, in the industry to deal with this in a timely
way. As time went by, more and more people got sick because we
weren't using all the tools in our toolbox to track down or
traceback the source of the contamination. Time is of the
essence and the industry and our state and local health and
agricultural officials are on the frontline and can narrow that
knowledge gap and close the time window when people are still
getting sick.
Collaboration with state and industry partners is key, and
in our home State of Florida, they have adopted mandatory
regulations on good agricultural practices and best management
practices for the production and handling of tomatoes through
all channels of commerce. It was developed as a cooperative
effort between the Department of Agriculture, the Florida
Department of Agriculture, the Florida tomato industry and the
FDA and they are based on sound science. They provide
traceability and they establish practices and procedures for
the safe handling of tomatoes. These state efforts should be
broadened through vehicles such as this legislation, the Safe
FEAST Act, to provide greater protection and traceability in
our food network both at the domestic level and at the
international level.
So, Mr. Chairman, I applaud your willingness to hold this
hearing. I appreciate all of the Members' work in jumping on
this issue and attempting to get something into the law that
modernizes our food safety network and system. I just want to
reiterate, it is in all of our interests to have a high
consumer confidence in the food supply in the United States.
There have been a series of incidents both in fresh produce, in
processed foods, in dog food and in toys, essentially in every
aspect of the consumer's world, there have been incidents over
the last 2 years that have continued to undermine that level of
confidence. It ought to be our challenge to restore the faith
and confidence of the American consumer and reiterate again
that American produce is the safest, cleanest and healthiest in
the world.
With that, I appreciate the opportunity and look forward to
your questions.
[The prepared statement of Mr. Putnam follows:]
Prepared Statement of Hon. Adam H. Putnam, a Representative in Congress
From Florida
I am Representative Adam H. Putnam, representing Florida's 12th
Congressional District, and it is my privilege to provide testimony to
the House Subcommittee on Horticulture and Organic Agriculture on an
issue of national significance, protecting the safety and security of
our country's food supply.
Thank you again for the opportunity to testify, and I also look
forward to the statements of those witnesses here today that serve ``on
the front line'' in ensuring the safety of the American food supply for
the public, as well as the testimony of those critical to providing
food resources for our country.
While our nation's food supply continues to be the safest in the
world, recent incidences of foodborne illness have highlighted
deficiencies in our food safety system that must be addressed.
The outbreak of Salmonella Saintpaul, said to be associated with
foodborne illness affecting in an estimated 1,284 persons, not only
called into question the integrity the system designed to protect our
nation's food supply for the safety and security of consumers, but also
caused significant disruptions to the food supply network and those
that produce agricultural goods for our nation.
This incident demonstrated that our governing food safety
authorities are outdated and must be reformed and enhanced to reflect
modern scientific standards and industry practices, as well sound and
strong policies implemented to help prevent food contamination.
The Safe Food Enforcement, Assessment, Standards and Targeting Act
``Safe FEAST Act'', H.R. 5904 which I am proud to have cosponsored with
my colleague from California and Member of the House Agriculture
Committee, Representative Jim Costa, would help ensure the highest
level of food safety protection for our nation's food supply, both for
goods produced domestically and those imported from abroad.
The comprehensive measure would modernize our food safety network
and would put into place new food safety standards all along the food
chain--from farm, harvest, processing, packing, distribution to retail
outlet, and finally to consumers--to identify and prevent potential
sources of foodborne illness.
The Safe FEAST Act calls for balanced, science-based food safety
requirements for farm and food companies, domestically and abroad,
implementing the principles of risk assessment and risk management, to
improve safeguards in our food supply as well as mitigate unwarranted
market disruptions to agricultural suppliers.
The bill focuses on strengthening preventative measures, building
upon existing regulations with tough--but common sense standards, while
expanding the tools of the Food and Drug administration (FDA) to more
effectively respond to food safety incidents in this nation.
This bipartisan bill strengthens the relationship between Federal
and state agencies to better control food safety threats, and for the
first time, and grants FDA new authorities powers to recall
contaminated food in the case of adulteration.
By reinforcing the public-private partnership, the Safe FEAST Act
improves FDA's role in safeguarding and overseeing the safe production
of food, while drawing upon the strengths of industry to meet the
highest food safety standards.
To ensure the highest level of food safety to American consumers,
H.R. 5904 requires all domestic and foreign food companies selling food
in U.S. to conduct a food safety risk analysis that identifies
potential sources of contamination, outlines appropriate food safety
controls, and requires verification that the food safety controls
implemented are adequate to address the risks of foodborne
contamination.
Similarly, to ensure that food products coming into the United
States from international sources are safe, imported goods would have
to adhere to the same safety and quality standards as set by the FDA,
through completing a Foreign Suppliers Quality Assurance Program,
documenting the food safety measures and controls for FDA review.
H.R. 5904 also establishes key new standards for fresh produce. It
improves and expands upon FDA's Good Agricultural Practices for the
safe production of fruits and vegetables. For those produce items that
are deemed to pose the highest risk, the bill calls for the issuance of
mandatory science-based regulations to prevent the occurrence of food
borne illness at all potential points of hazard, from farm to table.
While putting into place mandatory food safety standards for high-
risk produce, and voluntary guidelines for all other produce--the bill
and allows for variances in FDA regulations to meet local growing
conditions. It also directs FDA to collaborate with the U.S. Department
of Agriculture regarding agricultural practices in the issuance of
regulations.
The Safe FEAST Act strengthens the relationship between, Federal,
state and foreign governments agencies by increasing cooperation to
better control food safety threats, calling on the expertise and
resources of these partners to respond to food safety occurrences in a
more timely and efficient manner.
Collaboration with state and industry partners is key, as for
example my home State of Florida has adopted mandatory regulations on
Good Agricultural Practices (T-GAP) and Best Management Practices (T-
BMP) for the production and handling of tomatoes through all channels
of commerce. Developed as a cooperative effort between the Florida
Department of Agriculture and Consumer Services, the Florida tomato
industry, and the FDA, these best practices based upon sound scientific
research, provide traceability, and establish practices and procedures
for the safe handling of tomatoes.
These state efforts should be broadened, through vehicles such as
the Safe FEAST Act, to provide greater protection and traceability in
the food supply network at the national and international level.
Finally, to better control food safety threats, the Safe FEAST Act
directs the FDA to adopt a risk-based approach to inspections, grants
the FDA statutory power to recall contaminated food in the case of
adulteration, and gives FDA authority to access food safety production
records during foodborne emergencies.
The Safe FEAST Act is endorsed by several state, national and
international produce, food manufacturing and retail organizations
which have a high stake in maintaining safety and quality standards for
American consumers.
Thank you again for the opportunity to testify, and I appreciate
the Subcommittee's attention to this most important issue.
The Chairman. Thank you to both of you for being here. We
are going to engage in something somewhat unusual today.
Typically it is not the protocol of Members of Congress to ask
questions of their colleagues but both of our witnesses have
said that it would be okay with them for the Committee to ask
questions. In fact, I have talked to both of them about it in
advance, so I would just remind the Committee that you will be
recognized for questioning in order of seniority for Members
who were here at the start of the hearing. After that, Members
will be recognized in order of arrival. I appreciate the
Members' understanding.
I will start the questioning with my colleague, Ms.
DeGette. We spoke yesterday with regard to the farm bill that
had a marketing order approach. You have a tracking approach.
And the reality is, we don't see those as being out of sorts
with each other, that one can possibly help the other. In our
discussion yesterday, we discussed that a bit and I would like
you to share with the Members of the Committee your views,
since you have worked on this so long and so hard.
Ms. DeGette. Mr. Chairman, I think the real key role for
the Federal Government is to have a traceability system that
when there is evidence of a foodborne outbreak, then we have
some systems in place that allow immediate traceability. My
bill, 3485, does not legislate what that system will be, and
furthermore, I don't think that you would necessarily have the
same system for each segment of the food industry. As Mr.
Putnam wisely said, we have fresh produce, we have prepared
foods, we have meat, we have many other types of processes by
which food enters our economy, and so my view would be rather
that the FDA or the USDA should by working with industry to
develop systems of traceability that will take us from field to
fork and then make sure that those systems are interoperable. I
don't envision one size fits all. I don't envision necessarily
one system, but part of the problem we have had is that our
agencies have not--we have such spotty traceability throughout
our food system that we don't have an ability to quickly trace
foods. This is exactly what we have seen with the latest
foodborne outbreak and I don't think that that is in any way at
odds with what you are concerned with or what the legislation
envisioned.
The Chairman. Exactly. And Mr. Putnam, you raised, and I
would like you both to comment on this, that there is wide
variability between states and the capacity that each state
has. Certainly in California, I feel that California and
frankly in your State of Florida that the departments of
agriculture in those two states probably surpass the Federal
Government's capability of determining foodborne illness in a
very rapid fashion. I tried to get former Secretary of
Agriculture Bill Lyons from my district to testify here today.
He wasn't able to make it. But because he jumped on an outbreak
of illness in poultry, he was able to resolve the situation
before it affected the commercial flocks. And if you want to
comment both of you about the disparities between the states
and how you see those working in with your bills.
Mr. Putnam. I agree with you, Mr. Chairman, and I think
that is a reflection that these state departments of
agriculture recognize the importance not only to the consumer
but also to the producer of avoiding these types of outbreaks
and building consumer trust and confidence in the products that
are being grown in those states. Because of the substantial
economic loss that occurs when you have these types of
illnesses and you have these types of scares and the damage,
the economic damage lasts a lot longer than the life of the
Salmonella Saintpaul bug. And so, it proves the point that I
think both of us are making here, which is that the industry
recognizes that they need a robust risk assessment, risk
management system. They have, in many cases, in these
individual states pressed their legislature for a more robust
regulatory system that was also workable, that was practicable
and technologically feasible. This is an area where the grower
and the consumer are entirely overlapping in their interests
and that is why the states that tend to be large specialty
crop-producing states, fresh produce-producing states have
invested heavily in that type of a modern food safety system.
Ms. DeGette. And just to add, I think that is the point I
was going to make. States like California and Florida and
others have really instituted very sophisticated systems, but
those systems are not interoperable with each other across the
states. If a tomato from southern California is sent to
Colorado and there is an identification by the Colorado Health
Department of a foodborne outbreak, the Bioterrorism Act only
gives us one step up and one step back. So, you can't trace
that tomato all the way back to the field in California, which
is why we need a national system putting together all these
state systems. And just quickly let me add, an additional
problem that we are looking at in Energy and Commerce as well,
it is not just the food traceability systems, it is also the
public health systems where there is a real patchwork of
ability to identify the contamination from the beginning that
we need to deal with at a Federal level.
The Chairman. Thank you very much.
Mr. Neugebauer.
Mr. Neugebauer. Thank you, Mr. Chairman, and I thank both
of our panelists.
One of the things that Mr. Putnam--and I want to thank both
of you, and I know Mr. Putnam has been a huge advocate for food
safety and represents a very large state that has a lot of
production of citrus and fruits and vegetables for our country.
In your bill, as I understand it, you talk about things that
can be done from an agricultural perspective and then also what
happens to some of those agricultural products. You talk about
some of the authority in your bill would be given to the
Secretary of Health and Human Services, and then I heard both
of you saying what is important here is communication, of tying
the network all together, the states when there is a traceback
event. One of the concerns I have had is where we are dividing
food safety responsibilities between, in some cases, two
agencies, and then when you bring the CDC in, you bring another
agency in there, is this an issue, is this part of the problem?
In other words, that you are relying on agencies, you want
states to communicate, you want agencies to communicate, you
want state agencies to communicate with Federal agencies. I
guess the question I have, is the loop too big and would making
this food safety issue under one umbrella be something this
Committee should consider?
Mr. Putnam. Is that one for me?
Mr. Neugebauer. Either one of you.
Ms. DeGette. Let me say that ultimately I think we need to
have a conversation about whether it would make sense for us to
have a unitary food safety agency. This is an issue
Congresswoman DeLauro and I have been working together on for a
number of years. For example, why is it that the FDA has
jurisdiction over cheese pizzas and the USDA has jurisdiction
over pepperoni pizzas? That has never made a lot of sense to
me. But I think that would be a long and important discussion
to have.
In the short term, we can use our current system and
improve it by increasing technology and communication, and I
will give you an example. The CDC and its related health
departments and reporting agencies in the public health arena
actually communicate pretty well right now on identification of
foodborne diseases and they get the information in. The problem
is though, and we saw this with the most recent outbreak--I
hate to harp on that because I could really pick almost any of
the outbreaks--once they figured out that there was a foodborne
vector and what it was, then they reported to the FDA, which is
the chain of command. Then what happened was, the FDA was
unable to target exactly was it peppers or was it tomatoes, and
where did they come from, and using the Bioterrorism Act, it
just failed completely. So if we had a system in place that you
could trace those tomatoes all the way back to the field or the
peppers, that would help us go a long way in having very quick
traceability. That would help us at least minimize the extent
of the business damage because we would be having big recalls
and it would also help us quickly identify where that
contamination came from so we could minimize the disease.
Mr. Putnam. Thank you, Mr. Neugebauer. For as long as I
have been here and long before I got here, there has been a
discussion about a single food safety agency or not. The cheese
pizza example is sort of the classic example of what is
regulated by USDA, what is regulated by FDA, et cetera, and in
theory, you probably--I mean, you do look at this Byzantine
structure of food regulation and you say well, if we were going
to do it all over again, that is probably not how we would do
it. That is exactly how we approached the merger of all the
different agencies into the Department of Homeland Security,
and I hadn't been too thrilled with how that turned out. My
experience from bringing that same vision to Homeland Security
where we said, ``Gosh, it really doesn't make sense that you
have one agency looking for stuff and one agency looking for
people and one agency looking for bugs, and so we are going to
make it all into this really nice, neat, simple flow chart'',
and it just hasn't turned out the way we all hoped it would. I
think that the same would be true if we were to disrupt the
existing food safety and regulatory system that we have today.
But the same bureaucratic cultures and barriers that led us
to create the Department of Homeland Security exist today in
the food safety system where, for whatever reason, people are
reluctant to pick up the phone and say, ``Hey, we happen to
know a lot about tomatoes, I know you guys do public health, I
know that you can spot anthrax or you can spot smallpox or you
know that the West Nile virus is increasing in intensity. But,
maybe you don't understand the difference between the supply
chain of cilantro versus jalapeno peppers versus tomatoes
versus green peppers versus red peppers.'' Maybe we ought to
kind of break down this cultural aversion to seeking out people
who actually have the information about how the real world
really works. And in doing so, whether that involves bringing
in industry expertise or in bringing in state and local health
and industry expertise, I think all of those things will help
give us a more well-rounded system. It is not fair for Congress
to expect the FDA or the CDC to know everything there is to
know about the supply chain of every commodity grown in the
United States. It is not right for us to expect that of them. I
think it is appropriate for us to put in place a system that
allows them to rapidly tap into the expertise that is there.
It is cynical to believe that asking for industry expertise
is allowing them to be in charge of their own regulation. I
think that is a very cynical view because as we have seen, it
is in their best interest more than almost anyone else's to get
to the facts, to get to the truth, to end the spread of the
disease as quickly as possible and limit the damage. What is
not in their best interest is for government agencies to flail
around publicly speculating about which commodity it may or may
not be while people change their purchasing habits based on
that public speculation.
The Chairman. I as usual agree with both of you. Thank you
for being here.
It is come to my attention that we can be expecting a vote
any minute, so I am going to try and switch to the next panel
and try to get the testimony of the next two panelists in as
soon as possible. Thank you both for being here. You testimony
was as enlightening as I thought it would be.
The next panel of witnesses we would like to invite up is
Dr. Acheson, Associate Commissioner for Food Protection of the
U.S. Food and Drug Administration, Rockville, Maryland, and Dr.
Lonnie King, Director of the National Center for Zoonotic,
Vector-borne and Enteric Diseases, ZVED, of the Centers for
Disease Control in Atlanta, Georgia.
Dr. Acheson, I would call on you to give your testimony
first. You will probably hear the bells ring midway through
your speech but we will sit here and listen to both of you give
your testimony. And then hopefully we will ask you to stay
while we vote and we can come back and reconvene to ask
questions. Dr. Acheson, the floor is yours.
STATEMENT OF DAVID W.K. ACHESON, M.D., F.R.C.P.,
ASSOCIATE COMMISSIONER FOR FOOD PROTECTION, FOOD AND DRUG
ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES,
WASHINGTON, D.C.
Dr. Acheson. Thank you. Good afternoon, Chairman Cardoza
and Members of the Subcommittee, I am Dr. David Acheson,
Associate Commissioner for Food Protection at the Food and Drug
Administration, which is part of the Department of Health and
Human Services. Thank you for the opportunity to discuss the
recent foodborne illness outbreak associated with fresh produce
contaminated with Salmonella Saintpaul and the measures FDA is
taking to enhance the safety of fresh produce and to enhance
traceability.
There is no question that the Salmonella Saintpaul outbreak
investigation has been one of the most complex in recent
memory. I want to assure you that FDA is committed to working
with all of our food safety partners to expedite tracebacks and
to ensure that America's food supply continues to be among the
safest in the world. The number of illnesses associated with
fresh produce is a continuing concern for FDA and we have
worked on a number of initiatives to reduce the presence of
pathogens in these foods. Some of these activities include:
working with industry to develop guidance on ways to prevent or
minimize potential contamination; conducting educational
outreach to consumers on safe food handling practices; sampling
and analyzing both domestic and imported produce for pathogens;
and working with industry and foreign countries to promote the
use of good growing, harvesting, packing, transporting and
processing practices. We are also conducting research to
improve the identification and detection of disease-causing
bacteria in a variety of foods.
I would like to provide a brief description of the typical
traceback process. Once CDC and the state and local health
authorities, through their epidemiological investigations,
identify a possible food or foods associated with an outbreak,
CDC notifies FDA. At that point, we at FDA start our traceback
investigation to identify the source of the contamination. We
work with industry and the local, state and Federal officials
and, when needed, foreign governments, to identify the source
of the contamination. We do this by tracing the food suspected
of being the vehicle for transmitting the pathogen back through
the supply chain from the retailer or restaurant and inspecting
or investigating points throughout that supply chain to
determine where the contamination most likely occurred.
Tracing food requires us to find and examine documentation
such as bills of lading and invoices for the product throughout
the supply chain. We also obtain information on the practices
and the conditions under which the product was stored and
handled at each of those points.
The current investigation, which initially focused on
certain types of raw tomatoes, provides an example of one of
the most difficult kinds of traceback investigations. On May
31, the CDC advised FDA of the significant statistical
association between consumption of certain types of tomatoes in
a multi-state outbreak of Salmonella Saintpaul. Raw tomatoes
are a perishable commodity and thus are unlikely to be in the
consumer's home after a consumer becomes ill, obtains a
diagnosis and an outbreak is identified. Further, raw tomatoes
are often sold loose without any form of packaging. In the
current investigation, we learned that many tomatoes had been
shipped to washing, packing and repacking facilities where they
were or might have been commingled with other tomatoes from
different sources.
Since May 31, many FDA employees in the field and at
headquarters have been working continuously on the outbreak to
identify the sources of the illness. To help the public
distinguish tomatoes not associated with the outbreak, FDA
adopted the policy of specifically designating the types of
tomatoes implicated in the outbreak as well as listing growing
areas that were not part of the outbreak. On July 17, FDA
updated its consumer advisory and announced that tomatoes
currently on the market are not considered to be a possible
source of illness.
On July 21, a genetic match with the outbreak strain of
Salmonella Saintpaul in jalapeno peppers we had tested from a
distribution center in Texas was determined. This finding of a
genetic match was an important break in the investigation, and
upon further investigation, FDA determined that the
contamination of the peppers occurred in Mexico and not at a
plant in Texas. Accordingly, on July 25, FDA updated its
consumer advisory and announced that there was no indication
that domestically grown jalapeno or serrano peppers are
implicated in the outbreak.
To illustrate that point, I brought a chart with me that
demonstrates what we learned.
What I would like to point out here on this chart is over
on the left-hand side, a firm was identified that is in the red
box. That was the site which we found the positive pepper
sample in the McAllen, Texas, distribution center. Through our
investigations in Texas, we were able to trace that back
through the red dotted line to the facility at the center of
the diagram, which was in Mexico, and from there up to another
facility in Mexico and finally to the red box on the far side,
which is the grower where that pepper was grown. The rest of
this diagram illustrates what we were learning during that
process of the complexity of the potential tracebacks of
peppers in the State of Texas.
Two hours ago, we learned that we had gotten breaking news
in this regard. We have had our investigators in Mexico and
they had been investigating a specific farm taking samples,
looking for signs of the Salmonella Saintpaul outbreak, and 2
hours ago we learned that we had gotten a positive sample in
both the water used for irrigation and a sample of serrano
peppers from the same farm that matched the outbreak strain of
Salmonella Saintpaul. So this is a key breakthrough, and Dr.
Solomon is going to illustrate on here which farm that was. So
that is a key breakthrough.
Now, the other thing that we have learned today from the
investigation with our investigators in Mexico today----
Mr. Costa. Mr. Chairman?
The Chairman. Yes?
Mr. Costa. Could he move a little either on the other side
or move that around and----
The Chairman. Would it be possible to bring the easel up
forward, or do you have--oh, we do have documents.
Mr. Costa. That would be nice.
The Chairman. Thank you.
Mr. Costa. I am sorry to interrupt but----
Dr. Acheson. No, sure, please.
Mr. Costa.--my eyes aren't what they used to be.
Dr. Acheson. No, I apologize for taking a few extra moments
but this is breaking news and I wanted you to be current.
The Chairman. We love breaking news here. We like to get it
right as well. Thank you.
Dr. Acheson. So what we have learned is that the box there
with the new red square around it is where we found these two
positive samples. We have learned also that that farm is
distributing to a number of other places. You can see one arrow
already on there, and Dr. Solomon is going to draw three more
where we have now learned that this farm is distributing to a
variety of other places.
This is obviously critical information that is fresh off
the press as of, as I say, 2 hours. One of the key things that
we are learning is where the product from that farm has gone to
and what the investigators in Mexico are going to be doing
right now as the days move forward is identify where else might
those products have been distributed within the country of
Mexico before coming into the United States. And that will
eventually allow us hopefully to narrow this down to a specific
place.
Obviously one of the questions is, if we have contamination
on that farm but the pepper traced back to another farm, is
there a connection between the two? Is one shipping to the
other? Is there a common water supply? We know that the
contamination was in the water so is there a common water
supply or is there some other common point? And you can see
there again in the middle of that diagram, there is a
distribution center--Dr. Solomon, if you could point to that,
down one, there--where the peppers on the top part of the
diagram and the positives are passing through the same
distribution center.
Based on this, we are right now expanding our message to
consumers. We found a positive in serrano peppers and we are
recommending that consumers in the United States not only not
consume jalapeno peppers imported from Mexico but also serrano
peppers.
The Chairman. So is that a new advisory that will be going
out today?
Dr. Acheson. It is a new advisory as of right now, yes,
indeed, because we have now gotten a confirmed positive in
serrano peppers as well as jalapeno peppers, so both kinds of
peppers have tested positive for the outbreak strain. So the
message will be to consumers to avoid those kinds of peppers or
products made from fresh--these are fresh peppers. As before,
if they are processed, cooked or pickled, then they are not of
concern.
So that essentially is an update. I have already gone way
over my time. I recognize that, so I would be happy to take any
questions when you are ready.
[The prepared statement of Dr. Acheson follows:]
Prepared Statement of David W.K. Acheson, M.D., F.R.C.P., Associate
Commissioner for Food Protection, Food and Drug Administration, U.S.
Department of Health and Human Services, Washington, D.C.
Introduction
Good afternoon, Chairman Cardoza and Members of the Subcommittee. I
am Dr. David Acheson, Associate Commissioner for Foods 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 foodborne illness
outbreak associated with fresh produce contaminated with Salmonella
Saintpaul and the measures we are taking to enhance the safety of fresh
produce and to enhance traceability.
FDA is the Federal agency that regulates almost everything we eat
except for meat, poultry, and processed egg products, which are
regulated by our partners at the United States Department of
Agriculture (USDA). FDA is committed to ensuring that America's food
supply continues to be among the safest in the world.
There is no question that the Salmonella Saintpaul outbreak
investigation has been one of the most complex investigations in recent
memory. I assure you that FDA is committed to working with all our food
safety partners to examine ways to remove or mitigate some of the
complicating factors to expedite tracebacks. In my testimony, I will
discuss some of the factors that made this investigation so complex. I
will also describe some of the challenges we face both in preventing
fresh produce from becoming contaminated in the first place and in
investigating outbreaks associated with fresh produce. I will also
discuss some of the specific measures FDA is taking to enhance the
safety of fresh produce and other foods to prevent future outbreaks and
to improve traceability when an outbreak occurs.
Food can become contaminated at many different steps--on the farm,
in processing or distribution facilities, during transit, at retail and
food service establishments, and in the home. In recent years, we have
done a great deal to prevent both intentional and unintentional
contamination of food at each of these steps. FDA has worked with other
Federal, state, local, tribal, and foreign counterpart food safety
agencies, as well as with law enforcement and intelligence-gathering
agencies, and with industry, consumer groups, and academia to
significantly strengthen the nation's food safety and food defense
system across the entire distribution chain.
This cooperation has resulted in greater awareness of potential
vulnerabilities, the creation of more effective prevention programs,
new surveillance systems, and the ability to respond more quickly to
outbreaks of foodborne illness. However, changes in consumer
preferences, changes in industry practices, and the rising volume of
imports posed challenges that required us to adapt our current food
protection strategies and to develop the Food Protection Plan and the
Action Plan for Import Safety, which I will discuss later in my
testimony.
Challenges of Fresh Produce
The number of illnesses associated with fresh produce is a
continuing concern for FDA, and we have worked on a number of
initiatives to reduce the presence of pathogens in these foods.
Fresh produce presents special challenges. For example, consumption
of produce, particularly ``ready-to-eat'' products, has increased
dramatically during the past decade. This is a positive development
from a nutrition perspective, but also a new dynamic that challenges
our food safety efforts.
Because most produce is grown in an outdoor environment, it is
vulnerable to contamination from pathogens that may be present in the
soil, in agricultural or processing water, in manure used as
fertilizer, or due to the presence of animals in or near fields or
packing areas. Produce also may be vulnerable to contamination due to
inadequate worker health and hygiene protections, environmental
conditions, inadequate production safeguards, and inadequate sanitation
of equipment and facilities. Fresh produce is produced on tens of
thousands of farms, and contamination at one step in the growing,
packing, and processing chain can be amplified throughout the
subsequent steps. The fact that produce is often consumed raw or with
only minimal processing, without any type of intervention that would
eliminate pathogens (if they are present) prior to consumption,
contributes to its potential as a source of foodborne illness.
Consequently, addressing the way fresh produce is grown, harvested,
and moved from field to fork is crucial to minimizing the risk of
microbial contamination. In recent years, FDA has initiated several
activities to address safety concerns associated with the production of
fresh produce. Some of these activities include: working with industry
to develop guidance on ways to prevent or minimize potential
contamination, conducting educational outreach to consumers on safe
food handling practices, sampling and analyzing both domestic and
imported produce for pathogens, and working with industry and foreign
countries to promote the use of good growing, harvesting, packing,
transporting, and processing practices. For example, just last month,
FDA provided training in good agricultural practices in Costa Rica.
Research is also a critical element of our efforts to improve the
safety of fresh produce. 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 to identify contaminants are important for detecting
contamination if it is present and minimizing the spread of foodborne
disease once it occurs. In addition, we are working with academia,
industry, other Federal agencies, 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.
I would now like to provide a brief description of the typical
traceback process.
Traceback Process
Once CDC, through its epidemiological investigation which involves
working with state and local governments, identifies the possible
food(s) associated with a foodborne illness outbreak, CDC notifies FDA.
At that point, we start our traceback investigation to identify the
source of the contamination. We work with industry and with local,
state, and Federal officials, and, when needed, with foreign
governments, to identify the source of the contamination. We do this by
tracing the food suspected of being the vehicle for transmitting the
pathogen back through the supply chain from the retailer or restaurant
and inspecting or investigating points throughout the supply chain to
determine where the contamination most likely occurred. Tracing food
requires us to find and examine documentation (such as bills of lading
and invoices) for the product throughout the supply chain. We also
obtain information on the practices and conditions under which the
product was stored and handled at each point to better determine
shipments of interest and whether contamination may have occurred at
each point.
Traceback investigations involving fresh produce are more difficult
because the food is perishable and is usually no longer available for
testing by the time consumers become ill. In addition, fresh fruits and
vegetables are often sold loose without any packaging that could
provide information about its source. Further, practices such as
packing or repacking produce from multiple sources add complexity to
traceback investigations. As each traceback investigation is different,
I would like to mention three recent examples which illustrate the
different degrees of difficulty.
Peanut Butter
In 2007, CDC notified FDA of a multi-state outbreak of Salmonella
Tennessee infections associated with the consumption of peanut butter.
In this case, because it was not a perishable food, consumers who had
become ill still had jars of peanut butter available for testing. This
enabled investigators to confirm the presence in that food of the
contaminant associated with the outbreak. Further, because the food was
packaged, the investigators were able to identify the manufacturer
through the information on the jars. This is an example of a rapid
traceback in which the necessary information was readily available.
Fresh Spinach
In 2006, CDC informed FDA of a multi-state outbreak of illnesses
associated with the consumption of fresh spinach contaminated with
Escherichia coli O157:H7. Although this outbreak involved a perishable
food, the food was sold in a package. The traceback investigation was
facilitated because several consumers who had become ill still had
packages of fresh spinach in their refrigerators. The information on
those packages ultimately led investigators to the spinach processors.
By looking at the processor's records, the investigators were able to
identify the implicated farms associated with the identified production
lot of bagged spinach. This is an example of a traceback of medium
complexity that took a little longer than the peanut butter example but
which was aided by the information on the package.
Salmonella Saintpaul
The current outbreak investigation, which initially focused on
certain types of raw tomatoes, provides an example of one of the most
difficult traceback investigations. On May 26, CDC informed FDA of the
hypothesis of a possible association between ill persons and the
consumption of raw tomatoes. On May 31, CDC formally notified FDA of a
significant statistical association between consumption of certain
types of tomatoes and a multi-state outbreak of Salmonella Saintpaul
infections, and FDA decided to initiate investigations attempting to
trace the tomatoes reported to have been eaten by ill persons back to
their sources. Raw tomatoes are a perishable commodity and, thus, are
unlikely to be in the consumer's home after the consumer becomes ill,
obtains a diagnosis, and a foodborne illness outbreak is identified.
Further, raw tomatoes are often sold loose, without any form of
packaging. In this case, we learned that many tomatoes had been shipped
to washing, packing, and repacking facilities where they were or might
have been commingled with other tomatoes from many different sources.
This commingling has the potential to multiply the quantity of food
that is contaminated. It also increases the difficulty in determining
which tomatoes were the source of the illnesses. A further complicating
factor was caused by entities in the supply chain using different
terminology to describe the tomatoes. For example, one party might
describe the tomatoes as ``hothouse'' or ``greenhouse'' tomatoes while
the next party in the chain might describe them simply as ``tomato
bulk.'' Yet another party might use a descriptor such as ``green six-
by-six.'' This lack of consistency in nomenclature makes it more
difficult and more time-consuming to connect the links in the chain and
to identify the source of the tomatoes.
Salmonella Saintpaul Outbreak Investigation
Since May 31, many FDA employees in the field and at headquarters
have been working continuously on the outbreak investigation to
identify the source(s) of the illnesses. To help the public distinguish
tomatoes not associated with the outbreak, FDA adopted the policy of
specifically designating the types of tomatoes implicated in the
outbreak as well as listing growing areas that were not part of the
outbreak. Based on information provided by CDC, state officials, and
from our own investigations, FDA has been regularly updating the
information on its website, conducting media calls, and updating our
Federal, state, and local partners, along with the affected industries.
As is our usual course, FDA's recommendations for consumers were
focused on protecting public health and were based on epidemiological
information from the state agencies and CDC.
From them we learned initially that illness was statistically
linked to consumption of raw tomatoes. Ill persons reported consuming
red round, red plum, and red Roma tomatoes. Because few ill persons had
reported consuming other types of tomatoes, we advised consumers that
these other types of tomatoes had not been implicated. We also had
information from our ongoing traceback investigation that a limited
number of geographic regions were being identified as possible sources
of the tomatoes that were associated with the outbreak. A number of
states informed FDA that growers within their jurisdictions either were
not shipping tomatoes during the period of concern or they would not
have shipped tomatoes as widely as would have been required to account
for this multi-state outbreak. This aggregated information allowed us
to advise consumers that they could eat certain types of tomatoes and
all tomatoes from a number of countries and states (or from certain
regions within a state) with confidence that they were not from the
sources that were identified in the traceback investigation.
On June 30, CDC advised FDA that their epidemiological data from
the ongoing outbreak indicated that jalapeno and Serrano peppers also
might be implicated in the outbreak. Accordingly, on July 1, FDA
expanded its investigation into peppers as well and advised consumers
at increased risk of complications from infection (elderly persons,
infants, and persons with impaired immune systems) not to consume raw
Serrano and jalapeno peppers.
On July 17, FDA lifted its warning to consumers to avoid certain
types of raw tomatoes. FDA announced that tomatoes currently on the
market are not considered to be a possible source of the continuing
Salmonella Saintpaul illnesses because the tomatoes coming to market
now are harvested from different growing areas than those initially
implicated. We also reiterated our recommendation to consumers at
increased risk of infection to avoid eating Serrano and jalapeno
peppers while the investigation continues.
On July 21, FDA announced that one of the jalapeno pepper samples
we tested is a genetic match with the outbreak serotype, Salmonella
Saintpaul. This finding is strong evidence that jalapeno peppers were
involved in the outbreak; however, it does not exonerate other foods.
While this one positive sample does not provide the whole story, this
genetic match is an important break in the case that we hope will help
us pinpoint the source of the contamination. FDA obtained the jalapeno
pepper sample during an inspection of the Agricola Zaragoza produce
distribution center in McAllen, Texas. The company voluntarily issued a
recall. The pepper was grown in Mexico, but that did not mean the
pepper was contaminated in Mexico. We continued to investigate the
source of the contamination.
Based on this finding, on July 21, FDA advised consumers to avoid
eating fresh jalapeno peppers and foods made with them. This advisory
did not include cooked or pickled jalapeno peppers. As the traceback
investigation continued into the source of the pepper's contamination,
the review of the current traceback investigation and harvesting dates,
matched with the dates that people became ill, combined to indicate
that the contaminated jalapeno pepper originated in Mexico and not at
the plant in Texas. Therefore, on July 25, FDA announced that there was
no indication that domestically grown jalapeno or Serrano peppers are
implicated in the outbreak. We updated our consumer advisory to
indicate that our advice to avoid raw jalapeno and Serrano peppers now
applies only to peppers grown, harvested, or packed in Mexico. In
addition to domestically grown raw jalapeno and Serrano peppers,
canned, pickled, and cooked jalapeno and Serrano peppers from any and
all geographic locations also are not connected with this outbreak.
Serrano and jalapeno peppers are often grown together, are often served
in the same foods, and often travel along the same distribution routes.
The finding of the contaminated jalapeno pepper does not mean that
Serrano peppers were not also associated with the outbreak.
We are working with state regulatory agencies and the food
industry, including restaurants, grocery store chains, and wholesalers
to ensure that this new, more narrowly focused advisory is clearly
understood by everyone. Our investigation into the source of the
contamination is ongoing. We will continue to refine our consumer
guidance as our investigation continues.
I would now like to describe some of our recent activities to
improve traceability of fresh produce.
Recent FDA Activities To Improve Traceability of Fresh Produce
The ability to trace pathways of any food, including tomatoes and
other fresh produce, through every point in the supply chain is crucial
for limiting foodborne illness in an outbreak, for preventing future
outbreaks, and for reducing the impact on the segments of the industry
whose products were not associated with the illnesses. The pathways
that fresh produce travels from field to consumer have become
increasingly complex, with items sometimes changing hands many times in
the supply chain.
FDA formed an internal multi-Center group to meet with external
entities (such as industry, consumers, and Federal, state, local, and
foreign governments) to better understand the universe of track and
trace systems that are currently in use or being developed. FDA has
reached out to various organizations, including trade associations and
consumer groups, to gain a better understanding of best industry
practices for traceability, including the use of electronic and other
technologies that speed and enhance the traceback process and the use
of systems that connect all the links in the produce supply chain. FDA
is using this information to develop recommendations for the fresh
produce industry to use to improve its internal traceback systems. We
plan to hold a public meeting in the fall to further the exchange of
information on available technology and best practices for enhanced
traceability.
We have been working extensively with states and the fresh produce
industry to encourage incorporation of traceability procedures and
technology. For example, FDA assisted the Florida Tomato Commission and
the University of Florida/Institute of Food and Agricultural Sciences
in the development of Florida's Tomato Best Practices Manual. This
Manual incorporates Good Agricultural Practices, Good Handling
Practices, and traceability recommendations for industry. The Manual
formed the basis of the State of Florida's tomato safety rule.
Another recent example is the final guidance for the fresh-cut
produce industry, which FDA issued this year. The guidance includes a
section on tracebacks and a section on documentation and record-
keeping. FDA also has provided industry its ``Guide to Traceback of
Fresh Fruits and Vegetables Implicated in Epidemiological
Investigations,'' which is used by our investigators.
Last month, FDA issued a Request for Applications to provide
funding to six states to establish Food Protection Rapid Response Teams
to investigate multi-state outbreaks of foodborne illness. Enhancing
the infrastructure of state food protection programs and strengthening
joint Federal/state responsiveness at a local level are an important
way to protect consumers by expediting traceback investigations.
We will continue to work with Federal, state, local and
international food safety partners and with industry to develop
guidance, conduct research, develop educational outreach materials, and
initiate other commodity-, practice-, or region-specific programs to
enhance the safety of fresh produce.
Action Plan for Import Safety and Food Protection Plan
To enhance safety across the range of imported consumer products,
last November, Secretary Leavitt presented to the President an Action
Plan for Import Safety (Action Plan) which reflects the input of twelve
Departments and Agencies and provides recommendations to enhance the
safety of imported products. In conjunction with the Action Plan, FDA
released the Food Protection Plan, which provides a framework to
identify and counter potential hazards with respect to both domestic
and imported food. Achieving the food safety enhancements identified by
these plans will require the involvement of all our food safety
partners--Federal, state, local, tribal, and foreign governments;
industry; academia; consumers; and Congress. Both Plans build in safety
measures across a product's lifecycle, from the time a food is produced
to the time it is distributed and consumed. They encompass three core
elements: prevention, intervention, and response.
The Food Protection Plan identified ten legislative authorities
necessary for achieving full implementation. We encourage Congress to
provide these authorities, which would:
Allow FDA to require preventive controls against intentional
adulteration at points of high vulnerability in the food chain;
Authorize FDA to issue additional preventive controls for
certain high-risk foods;
Require food facilities to renew their FDA registrations at
least every 2 years and allow FDA to modify the current food
product categories for purposes of registration;
Authorize FDA to accredit highly-qualified third parties for
voluntary food inspections;
Require a new reinspection fee from facilities that fail to
meet current Good Manufacturing Practice (cGMPS) requirements;
Empower FDA to require electronic import certificates for
shipments of designated high-risk products from countries with
which FDA has concluded an agreement on a certification program
that provides a level of safety sufficient to meet FDA
standards;
Allow FDA to charge export certification fees for food and
animal feed to improve the ability of U.S. firms to export
their products;
Authorize FDA to refuse admission of imported food if FDA
inspection access is delayed, limited or denied;
Empower FDA to issue a mandatory recall of food products if
voluntary recalls are not effective; and
Give FDA enhanced access to food records during emergencies.
Last month, the Secretary announced that the Administration is
increasing its Fiscal Year (FY) 2009 budget request for FDA by $275
million. This increase brings the Administration's total proposed
increase in FDA's budget, including user fees, for FY 2009 to $406.3
million, a 17.9% increase over FY 2008. A large portion of this
increase ($125 million) will be used for food safety and will allow FDA
to intensify actions to implement the Food Protection Plan. This is in
addition to the $42.2 million increase proposed for food protection in
the budget announced in February 2008.
On June 30, the President signed the FY 2008 Supplemental
Appropriation into law. This appropriation act provided $150 million
for FDA, and these resources will allow FDA to accelerate its
transformation of its regulatory strategies to meet the challenges of
the evolving global marketplace for food and medical products. The
funds in the supplemental appropriations act will allow FDA to further
implement the Food Protection Plan, the Action Plan for Import Safety,
and important medical product priorities. It will specifically allow
FDA to expand its food safety activities, such as increasing
inspections, performing research on mechanisms of food contamination,
establishing offices overseas to build capacity with our foreign
partners, developing and validating more rapid detection tools,
enhancing our information technology systems to support interoperable
databases, and enhancing FDA's ability to identify and target the
greatest threats from intentional and unintentional contamination.
Conclusion
FDA is working hard to ensure the safety of food, in collaboration
with its Federal, state, local, tribal, and international food safety
partners, and with industry, consumers, and academia. As a result of
this effective collaboration, the American food supply continues to be
among the safest in the world. However, the Salmonella Saintpaul
foodborne illness outbreak underscores the challenges we face. Once our
investigation has determined the cause of the Salmonella contamination,
we will examine what other measures are needed.
In the meantime, we have been making progress and are moving
forward to implement the Plans. We recently issued 6 month updates that
demonstrate the specific actions we have been taking to implement the
Plans. For example, we have formed a Risk-Based Steering Committee with
the charge of ensuring that a comprehensive risk-based approach is
taken with regard to food protection. We are holding a 50 state meeting
in August to share information and develop strategies for implementing
the Food Protection Plan and to enhance future collaborations between
Federal, state, and local partners. Progress also has been made in
identifying food vulnerabilities and mitigation strategies; for
example, FDA has identified several natural plant bacteria that are
effective in preventing contamination of tomatoes with Salmonella
Newport. FDA scientists received training and instruments to rapidly
detect and accurately identify Salmonella serovars using a new
molecular method. We have strengthened the response to food safety
threats by providing incident command system training to our FDA
offices around the country and to states and by developing templates to
enhance communication during a food recall. We 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 continuing efforts
to enhance food safety and traceability. I would be happy to answer any
questions.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
I am sure the Committee will have a series of questions. We have just
gotten called for a vote. I would like Dr. King to be able to present
his oral testimony before questions, and we will take that at this time
and then we will come back, because I know the Committee as do I have a
number of questions with regard to the announcement you have just made
as well as how consumers can protect themselves as well as if you know
the cause of the water contamination in Mexico.Dr. King, please
proceed now.
STATEMENT OF LONNIE J. KING, D.V.M., DIRECTOR, NATIONAL CENTER FOR
ZOONOTIC, VECTOR-BORNE AND ENTERIC
DISEASES, CENTERS FOR DISEASE CONTROL AND
PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON,
D.C.
Dr. King. Thank you very much, Mr. Chairman. Good afternoon. I am
Lonnie King. I am the Director of the National Center for Zoonotic,
Vector-borne and Enteric Diseases at the CDC. Thank you for the
invitation to address the Subcommittee today.
First, let me offer my sympathies to all families who have been
adversely affected by this outbreak and also I understand the
frustration of many of the food-producing and serving industries who
work so very hard to produce and serve safe produce.
CDC leads Federal efforts to gather data and investigate foodborne
illnesses. Much of what CDC does depends on the critical relationships
with a broad range of partners, food safety regulatory agencies, in
particular with the FDA, the USDA's Food Safety Inspection Service and
with the state and local public health departments.
Salmonella is a group of bacteria that is widespread, mostly in the
intestines of birds, reptiles and mammals. There are some 2,500
subtypes, or serotypes. Salmonella is the second most common bacterial
cause of foodborne illness in this country. The current outbreak of
Salmonella caused by the serotype Saintpaul is relatively uncommon as a
serotype, causing only about one percent of all reported Salmonella
infections each year. This outbreak is the largest foodborne outbreak
in the United States in the past decade. Its investigation has been
especially complex, difficult and, unfortunately, prolonged.
CDC first learned about the outbreak on May 22, 2008, when the New
Mexico Department of Health reported illnesses in four individuals
confirmed as Salmonella Saintpaul. New Mexico posted the information
about this unusual number of Salmonella Saintpaul cases to PulseNet, a
national network of public health and food regulatory agency
laboratories used to detect foodborne disease outbreaks. This
information allowed state laboratories to compare the specific DNA
fingerprint found in New Mexico to their own cases of Salmonella and to
report any cases where there may be matching fingerprints. The very
next day, Texas and Colorado reported cases with matching fingerprints.
Investigators in New Mexico, Texas and CDC began a multi-state outbreak
investigation. Epidemiologists conducted hypothesis-generating
interviews with ill persons to collect information about many possible
sources of infection. Results of this first series of interviews
indicated raw tomatoes were the most commonly consumed food, leading to
the hypothesis that they are possible source of illness. Following
these initial interviews, case control studies comparing what ill and
healthy persons reported eating were conducted. By May 31, preliminary
results of the first case control study showed that illnesses were
significantly associated with the consumption of raw tomatoes.
On June 4, CDC received the first report of a possible restaurant
cluster and subsequently learned of additional clusters. Between June
18 and June 20, there was also a large surge of reported cases from
Texas. The geographic concentration of illness in the Southwest and in
Native American and Hispanic persons along with a strong association
with the consumption of Mexican-style food in restaurants and the
apparent continuation of this outbreak after the alert regarding
tomatoes led to the hypothesis that a food item commonly consumed with
tomatoes could also be producing this illness.
Investigations then focused on the recently identified clusters and
a second multi-state case control study of persons who became ill after
June 1 was initiated. The results of the case control study indicated a
strong link to fresh produce items used in Mexican cuisine but did not
point clearly to a specific item. After additional epidemiologic
investigations of a cluster of illness in Texas, the FDA began their
tracebacks on peppers, and on June 21, the FDA announced they had
isolated the outbreak strain of Salmonella Saintpaul from a sample of
jalapeno peppers, and we now know that other information has come
forward. This outbreak continues as does the investigation. The active
field investigations by the CDC, state and local health departments
focusing on identifying clusters of cases and the FDA's tracebacks on
jalapenos, tomatoes and other possible sources are providing new
information almost on a daily basis.
This outbreak has been particularly challenging. First, there is an
inherent delay when a person becomes ill with Salmonella and when
results of the tests are reported to PulseNet. For half the cases in
this outbreak, it took more than 16 days from onset of illness to
posting the test results on PulseNet. Second, people have difficulty
remembering exactly what foods they ate and remembering specific
ingredients in those foods was even more difficult, especially in
dishes that were prepared by someone else. Third, the foods in question
are often eaten together, so exposures to one item often means
exposures to all the items. Finally, perishable foods consumed by ill
persons were often not available for testing.
As of July 29 at 9 p.m., 1,319 persons infected with Salmonella
Saintpaul have been identified in 43 states, the District of Columbia
and Canada. At least 255 persons have been hospitalized with two deaths
possibly linked to this outbreak. At present, we believe that jalapeno
peppers are the cause of some of these clusters and could be a major
vehicle that we need to look at as part of this outbreak. Fresh serrano
peppers, with this new information today from FDA, not only remain
under investigation but now we have a smoking gun, it appears.
It also appears likely that more than one food vehicle has been
involved in this outbreak. I think that has been confirmed by FDA
today. By themselves, tomatoes cannot explain this entire outbreak nor
do jalapeno peppers explain all of the clusters. The outbreak is
ongoing but fortunately fewer new illnesses are reported each day.
In conclusion, the outbreak illustrates the importance of existing
public health networks: the laboratories that use and perform PulseNet
fingerprinting; the epidemiologists conducting the investigations; the
multidisciplinary approach to the investigation and the close
communication and collaboration among state, local and Federal
officials. We balance the rapid release of information on the sources
of illness against the potential negative consequences to consumers,
food growers, producers and industry. CDC is prepared to continue to
work with its regulatory authorities, state and local partners, food
and environmental microbiologists and the food industry to find long-
term solutions to this very challenging problem.
I appreciate being here today, and your kind invitation to testify.
After your vote I would be happy to answer any questions you may have.
[The prepared statement of Dr. King follows:]
Prepared Statement of Lonnie J. King, D.V.M., Director, National Center
for Zoonotic, Vector-borne, and Enteric Diseases, Centers for Disease
Control and Prevention, U.S. Department of Health and Human Services,
Washington, D.C.
Introduction
Good afternoon, Chairman Cardoza and Members of the Subcommittee. I
am Dr. Lonnie King, Director of the National Center for Zoonotic,
Vector-borne, and Enteric Diseases, at the Centers for Disease Control
and Prevention. Thank you for the invitation to address the
Subcommittee on CDC's activities related to the prevention of foodborne
disease and CDC's role in the response to the current outbreak of
Salmonella Saintpaul infections associated with fresh produce. First,
let me offer my sympathies to all the families who have been adversely
affected by this outbreak. Second, I understand the frustration of many
in the food producing and serving industries, who work very hard to
produce and serve safe produce. This investigation has been especially
difficult and prolonged. We have faced many challenges with this
particular foodborne outbreak. I will discuss these challenges in more
detail after describing the CDC's response to the Salmonella Saintpaul
outbreak.
Background
Foodborne disease presents a continuing challenge to public health.
CDC estimates that approximately 76 million U.S. residents get sick,
325,000 are hospitalized, and 5,000 die each year from foodborne
illness. Overall, foodborne diseases appear to cause more illnesses but
fewer deaths than previously estimated in the 1980's. More than 250
different foodborne illnesses have been described. Most are caused by a
variety of bacteria, viruses, and parasites. Some foodborne illnesses
are caused by toxins or chemicals.
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 United States Department of Agriculture (USDA). CDC also plays a
key role in building state and local health department epidemiology,
laboratory, and environmental health capacity to support foodborne
disease surveillance and outbreak response. Notably, CDC data can be
used to help document the effectiveness of regulatory interventions.
Much of what CDC does depends on critical partnerships with state
and local public health departments who collect surveillance data and
investigate most outbreaks themselves. CDC has worked with the
Association of Public Health Laboratories (APHL) and the Council of
State and Territorial Epidemiologists (CSTE) to strengthen networks for
foodborne disease surveillance. For example, PulseNet, the national
network for molecular subtyping of foodborne bacteria coordinated by
CDC, empowers every state health laboratory to test strains of bacteria
from sick persons in that state, and to compare them with DNA
``fingerprint'' patterns in the national database at CDC. This has
greatly improved the ability to detect clusters of illness that may be
related, even if they are dispersed across multiple states.
OutbreakNet is the group of public health officials at state health
departments and CDC who regularly investigate foodborne outbreaks. The
OutbreakNet team at CDC coordinates the investigation of the large,
multi-state clusters and works with the foodborne disease
epidemiologists in each state to evaluate clusters that PulseNet
detects. The OutbreakNet team at CDC also manages the electronic
Foodborne Outbreak Reporting System (eFORS). Established in 2001, eFORS
is a web-based outbreak surveillance system through which state and
local health departments voluntarily submit completed reports of
foodborne disease outbreak investigations to CDC.
CDC's Environmental Health Specialists Network (EHS-Net), a
collaborative effort with FDA and nine states, assists state health
departments in their efforts to improve the practice of environmental
health service programs; participants assess policies and practices of
retail foodservice establishments that could lead to or prevent
foodborne outbreaks. FoodNet is a network that is a collaborative
effort among CDC, ten states who participate in CDC's Emerging
Infections Program, the Department of Agriculture's Food Safety and
Inspection Service (USDA-FSIS), and FDA; it provides the most accurate
surveillance data for determining the burden of infections, conducts
scientific studies to better understand the sources for the many
illnesses that occur outside the outbreak setting, and monitors trends
in infections as new control measures are instituted. 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.
CDC also works with a broad range of other partners to improve
capacity and knowledge regarding foodborne disease control and
prevention. In collaboration with the National Environmental Health
Association (NEHA), CDC conducts team training programs for local and
state health department officials including specialists in
environmental health, laboratory, and epidemiology. CDC works with the
World Health Organization (WHO) and a variety of other international
partners to conduct similar training programs in other countries
through the WHO Global Salmonella Surveillance program. CDC supports
the Council to Improve Foodborne Outbreak Response (CIFOR) which was
created to help develop model programs and processes that will
facilitate the investigation and control of foodborne disease
outbreaks. CSTE and the National Association of County and City Health
Officials (NACCHO) are co-chairing CIFOR, and it includes
representatives from CDC, FDA, USDA, APHL, NEHA, the Association of
State and Territorial Health Officials, and the Association of Food and
Drug Officials.
Salmonella
Salmonella is a group of bacteria that is widespread in the
intestines of birds, reptiles, and mammals. Salmonella bacteria have
been known for over 100 years to cause human illness. Salmonella is the
second most common bacterial cause of foodborne diseases in the
country, causing 15 reported laboratory-confirmed infections per
100,000 population in 2007, as measured in FoodNet. There are many
different kinds, or serotypes, of Salmonella bacteria. Serotyping is a
classification system based on differences in structures on the
surfaces of bacteria or other disease-causing agents. Serotyping
divides Salmonella into more than 2500 different serotypes, some common
and some rare. For example, during 1996-2006, Salmonella serotype
Typhimurium and Salmonella serotype Enteritidis typically caused 41% of
reported Salmonella illnesses each year in the United States.
Salmonella serotype Saintpaul is relatively uncommon, causing only 1%
(about 400) of all reported laboratory-confirmed Salmonella infections
each year. Each serotype can be further sub-divided into many more
subtypes based on their DNA.
Salmonella infections have often been associated with meat,
poultry, eggs, and raw milk; these products are derived from animals
that can carry Salmonella. Salmonella has also been associated with
fresh produce and other plant-derived foods. Fresh produce can be an
important source of other types of foodborne infections as well; for
example, Escherichia coli O157, another bacterial agent, caused a large
outbreak of illness linked to spinach in 2006. Salmonella, like other
pathogens that are commonly foodborne, can also be transmitted in other
ways, such as from contact with reptiles or other animals or between
children at a child care center.
Many foodborne infections, including Salmonella, occur in persons
without obvious connections to each other. 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
were connected and, specifically, if they were linked to food. A
cluster of foodborne illnesses is considered an outbreak if an
investigation demonstrates that two or more infections caused by the
same agent are linked to the same food.
In general, for a foodborne illness to be recognized by the public
health surveillance system, a patient must seek medical attention, the
physician must decide to order diagnostic tests, and the laboratory
must conduct the test using the appropriate procedures and report the
results to a health department. Many ill people do not seek medical
attention, and of those who do, many are not tested. Therefore, many
cases of foodborne illness are neither diagnosed nor reported. For
example, Salmonella infection has been estimated to cause about 1.4
million foodborne illnesses annually, however, only about 40,000
laboratory-confirmed cases of Salmonella are reported to CDC each year.
Regular reporting about detection of Salmonella serotypes from ill
persons is critical in determining whether a change in incidence has
occurred signaling a possible outbreak. Each serotype can be further
divided by DNA analysis into subtypes. The subtypes are distinguished
by different DNA fingerprint patterns. The fingerprint pattern is
determined with a test known as pulsed-field gel electrophoresis
(PFGE). PFGE is a very good method for discriminating between
epidemiologically unrelated isolates of this serotype. Public health
laboratories determine the serotype and PFGE patterns for Salmonella
strains and share the patterns through PulseNet. PulseNet plays a vital
role in surveillance for and investigation of widely dispersed
foodborne illness outbreaks that were previously difficult to detect.
The laboratories participating in PulseNet are in state health
departments, some local health departments, USDA, and FDA. When a
clinical laboratory detects Salmonella from an ill person, a sample is
sent to a state or local PulseNet laboratory where it is serotyped and
DNA fingerprinted. The laboratory compares the fingerprint pattern to
that of other Salmonella strains from people in that area and uploads
the pattern electronically to the national PulseNet database maintained
at CDC, where it can be compared with the patterns from all over the
country. This gives us the capability to detect an unusual number of
Salmonella cases with the same pattern in a single area or in multiple
states. The system can identify patterns even if the affected persons
live far apart, which is important given the widespread U.S. food
distribution systems. The pattern causing the current outbreak is
usually quite uncommon, and was identified only 25 times in 2007, among
the 400 Salmonella Saintpaul infections that were reported.
It is important to recognize there is an inherent delay between
when a person becomes ill with Salmonella infection and when the
results of testing are reported to PulseNet. In the current Salmonella
Saintpaul outbreak, the median number of days between when the illness
began and when the fingerprint pattern was reported to PulseNet has
been 16 days. It takes time for a person to become ill, seek medical
care, submit a sample for testing; it then takes time for the clinical
laboratory to detect Salmonella and send the strain to the public
health laboratory; it then takes time for the public health laboratory
to perform serotyping and DNA fingerprinting.
The Salmonella Saintpaul Outbreak
On May 22, 2008, the New Mexico Department of Health contacted CDC
to report that they were investigating illness in four persons with
Salmonella Saintpaul strains that had the same DNA fingerprint pattern,
and that Salmonella strains from 15 more persons were still being
characterized. The DNA fingerprint determined by PFGE was rare. It
usually occurs no more than 2-3 times a month in the whole United
States, so four or more in one location was unexpectedly high. New
Mexico posted the information about the unusual number of Salmonella
Saintpaul cases to the PulseNet web board on May 22, so that all state
laboratories could quickly compare the DNA fingerprint pattern with
that of their own strains, and CDC requested that states report any
strains that matched the DNA fingerprint pattern. That next day, Texas
and Colorado reported cases with this PFGE pattern, and investigators
in the New Mexico Department of Health, the Navajo Nation, the Indian
Health Service, the Texas Department of State Health Services, and CDC
began a multi-state investigation. Daily multi-state conference calls
began and continued through July, with states being added to the calls
as their cases were identified. The investigation was initially
coordinated by the New Mexico State Health Department, because most
identified cases were in that state. On June 3, after more states in
different regions of the country reported cases, CDC assumed this role
of the investigation.
The initial steps in an epidemiological investigation are to
collect information from which hypotheses can be generated about the
possible source of the outbreak. As cases with the same DNA fingerprint
pattern were identified, epidemiologists interviewed patients to
determine what specific foods or other exposures they may have had in
common. The New Mexico Department of Health, Texas Department of State
Health Services, and the Indian Health Service conducted hypothesis-
generating interviews from mid to late May among 19 ill persons from
whom Salmonella Saintpaul with the DNA fingerprint matching the
outbreak strain had been isolated during May 2008. These interviews
collected information about possible sources of infection, including
attendance at gatherings, travel, daycare contact, contact with
reptiles and/or other household pets, contact with farm animals,
sources of drinking water, history of swimming, eating at restaurants,
and specific food consumption history for approximately 200 food items;
the interviews also included open-ended questions about what ill
persons had eaten, meal by meal, in the days before they became ill.
The preliminary results of this first series of interviews indicated
raw tomatoes were the most commonly consumed food item (reported by 84%
of ill persons) leading to the hypothesis that they were a possible
source of the illnesses. CDC informally advised the FDA on May 26 of
the hypothesis of a possible association between ill persons and the
consumption of raw tomatoes.
In the next steps of the investigation, analytic epidemiologic
studies were conducted to test the hypotheses generated by case
finding. These studies compare the frequency with which ill persons
report exposure to a particular food item to the frequency with which
healthy persons (or controls) report that exposure. If the ill group is
more likely than the well group to report exposure to a particular
food, a statistical test can show how likely this finding would have
occurred by chance alone. Additional information about the likelihood
of that particular food actually being contaminated, the biological
plausibility of it causing the illnesses, the fit of the cases with the
distribution of the food, and other factors may enter into the
professional judgment of whether the food with a statistically
significant association with cases is likely to explain the outbreak.
Preliminary findings from these types of studies guided subsequent next
steps of the investigation while additional statistical analyses are
being conducted on the data gathered. It is important to keep in mind
at this stage of investigation, as analyses are conducted and
interpreted, that initial findings and hypotheses may change. As is
common in outbreak investigations but especially true for foodborne
outbreaks, the process of case finding, hypothesis generating, and
hypothesis testing is an iterative process; each step informs
subsequent steps and often leads to new investigative avenues.
In the next phase of the investigation, in late May, the New Mexico
Department of Health, the Texas Department of State Health Services,
and the Indian Health Service, in consultation with CDC, conducted a
multi-state case-control study. The data from the earlier 19 hypothesis
generating interviews were used to identify which foods were most
frequently consumed by the ill people. The questionnaire used in this
case-control study included the 14 foods \1\ reported by half or more
of the ill people in the hypothesis-generating interviews. These
questionnaires were administered to approximately 150 people. By May
31, preliminary results of the case-control study demonstrated that
illness was significantly associated with consumption of raw tomatoes
(88% of cases consumed raw tomatoes compared with 64% of the controls,
a very strong statistical difference). FDA was formally notified of
this significant association between tomatoes and infection.
Statistical analysis of these data showed that illness was associated
with consumption of raw tomatoes independent of consumption of tomatoes
in salsa, guacamole, or pico de gallo.
---------------------------------------------------------------------------
\1\ Food items examined included tomatoes, eggs, ice cream,
potatoes, milk, tortillas, cold breakfast cereal, raw onions, salsa,
avocado, guacamole, ground beef, chicken, and lettuce.
---------------------------------------------------------------------------
The next step in the investigation was to trace the implicated food
back to its sources, looking for points where contamination might have
occurred, and to determine if there is a single farm, processing
location, or other point in distribution system that could explain all
the illnesses providing additional evidence supporting the food item as
a cause of the outbreak. Tracing the implicated food back from
consumption through preparation, to distributors, and source can also
help determine how the contamination occurred, stop distribution of the
contaminated product, and prevent further outbreaks from occurring. On
May 31, 2008, FDA decided to initiate investigations attempting to
trace the tomatoes reported to have been eaten by ill persons back to
their sources. Tracebacks began on June 1, 2008. Throughout the
investigation there has been ongoing communication between CDC and FDA
regarding these traceback investigations.
On June 4, CDC received the first report of a possible restaurant
cluster. Four cases in Illinois appeared to be related to exposure to a
single restaurant. Such clusters were otherwise absent in the early
part of the outbreak. The outbreak continued and expanded. Over the
next few weeks, hundreds more cases were reported from an increasing
number of states. The average number of persons who became ill between
May 20 and June 10 was 33 per day. New information emerged as each case
was reported and interviewed by local or state health department
authorities.
On June 16, CDC learned about the first recognized large cluster
linked to a single restaurant, approximately 30 illnesses, in Texas.
Between June 18 and June 20, Texas reported an additional 134 cases.
This surge in the number of cases from Texas highlighted the geographic
concentration in the Southwest and in Native American and Hispanic
persons, which did not have a clear explanation. This information,
along with the strong association between illness and consumption of
Mexican-style foods in restaurants coming from continued analysis of
the case-control studies, and the apparent continuation of the outbreak
after the alert regarding tomatoes, led to the hypothesis that a food
item commonly consumed with tomatoes could be causing illnesses.
Epidemiologists decided to focus the investigations on the recently
identified clusters and to conduct a case-control study of persons
nationwide who became ill in June. CDC offered assistance to the Texas
Department of State Health Services; a CDC Epi-Aid team arrived in
Texas on June 19.
By July 7, 32 clusters of Salmonella Saintpaul infections with the
PFGE pattern of the outbreak strain had been identified in 13 states
and the District of Columbia. Twenty-six were associated with Mexican-
style restaurants. Most clusters had fewer than five ill persons. Three
clusters had more than ten ill persons, and analytic studies have been
conducted on these. In one of these larger restaurant clusters,
illnesses were linked to consumption of an item containing fresh
tomatoes and fresh jalapeno peppers. In the other two, illnesses were
linked to an item containing fresh jalapeno peppers but neither raw
tomatoes, nor fresh cilantro. Among the 22 smaller clusters with data
on the presence of food items in the venue, four did not serve jalapeno
peppers. Together, these investigations indicated that jalapeno peppers
caused some illnesses, but did not appear to explain all illnesses. Raw
tomatoes, fresh serrano peppers, and fresh cilantro also remained under
investigation. We were strongly considering the probability that more
than one food item caused illness.
CDC and state and local health departments conducted a second case-
control study to investigate the possibilities that illness was related
to consuming foods in Mexican-style restaurants, and that illness was
associated with consuming, in a restaurant, event, or home, a range of
produce items that are often served with tomatoes, including freshly
made salsa, fresh jalapeno peppers, and fresh cilantro. This was a
large multi-state study, with over 400 interviews, with 141 interviews
from persons who had become ill on or after June 1 and 281 interviews
from healthy controls available for preliminary analysis. The study
showed that illness was strongly associated with eating at a Mexican-
style restaurant. In a preliminary statistical analysis that considered
the entire dataset, consumption of fresh tomatoes, jalapeno peppers,
and cilantro were each shown to be risk factors in subgroups but no
single suspect exposure statistically dominated the others in
explaining all cases. Thus, this study indicated a strong link to fresh
produce items used in Mexican cuisine but did not point clearly to one
specific item.
As new restaurant-associated clusters were reported, CDC and state
health departments investigated them aggressively. By July 16, CDC
investigators were assisting state and local health officials in field
investigations of restaurant clusters in North Carolina, Missouri,
Texas, and New York City. In addition, another CDC team was
investigating illnesses in New Mexico.
As the epidemiological investigation expanded, the FDA also
expanded their traceback and sampling efforts. FDA began their
tracebacks on peppers identified by the outbreak investigations
conducted by the states and CDC. CDC sent two medical epidemiologists
to FDA to directly participate in analyzing findings from the
tracebacks and connect them with the CDC epidemiologic data. On July
21, the FDA announced that they had isolated the outbreak strain of
Salmonella Saintpaul from a sample of jalapeno peppers. The
epidemiologic data from a Texas cluster of ill persons led to this
specific traceback investigation. In most Salmonella outbreaks that are
linked to a particular food, however, Salmonella is never detected in
the food. Detection of Salmonella in a food item that was implicated in
an epidemiologic study provides strong evidence that this food item
caused illnesses, though it does not exclude other foods as possible
causes of illness.
Throughout the investigative process, 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.
We balance the rapid release of information on sources of illness
against the potential negative consequences to consumers, food growers,
producers, and industry. Continued collaborations and communications
between Federal agencies, state and local health departments, and all
relevant stakeholders are essential.
Challenges Confronting the Outbreak Investigation
Every outbreak response is a challenge for everyone involved. This
outbreak was particularly challenging in a number of ways. As already
mentioned, it takes time for a case to be reported to public health
authorities and then investigated. For half the cases in this outbreak,
it took more than 16 days from when the person became ill to the when
the DNA fingerprint of their Salmonella was added to the PulseNet
database. The resulting delay sometimes prevented interviews from
occurring while memories were still fresh. The precision of interviews
by epidemiologists depend on the observations and memories of people
about what they ate and what ingredients the dishes contained. People
often have difficulty remembering exactly what foods they ate, and
remembering specific ingredients in those foods is even more difficult,
especially if the dish was prepared by someone else, or eaten in a
restaurant. Another challenge has been that the foods in question are
often eaten together--many salsa, guacamole, and pico de gallo recipes
contain tomatoes, jalapeno peppers, and cilantro, so exposure to one
item often means exposure to all three. When food items are mixed
together and consumed in the same dish, all the items may be
statistically linked to illness. In that case, it can be difficult or
impossible to separate out the risk from individual foods without
additional information such as microbiological culture or traceback of
the foods. Although laboratory testing of foods might help identify the
source of an outbreak, perishable foods that were consumed by ill
persons were often not available to test. This is in contrast to
outbreaks from frozen or processed foods which may still be present in
someone's freezer or pantry weeks later. Finally, the traceback of
fresh produce, such as tomatoes, through the supply chain can be very
difficult and labor intensive. Doctor Acheson will be able to say more
about this.
Status of Investigation
As of July 27, 1304 persons infected with Salmonella Saintpaul with
the same fingerprint have been identified in 43 states, the District of
Columbia, and Canada. At least 252 persons were hospitalized. Two
deaths were possibly linked to the outbreak: A man in his eighties who
died in Texas from cardiopulmonary failure had an infection with the
outbreak strain at the time of his death. A man in his sixties who died
in Texas from cancer had an infection with the outbreak strain at the
time of his death.
Three larger clusters were intensively investigated as of July 7.
In one, illnesses were linked to consumption of an item containing
fresh tomatoes and fresh jalapeno peppers. In the other two, illnesses
were linked to an item containing fresh jalapeno peppers and no other
of the suspect items. Since then, detailed investigations of three
other clusters indicate that jalapeno peppers do not explain all
illnesses. In two of these more recent investigations, illnesses were
linked to an item containing fresh serrano peppers and tomatoes, but
not jalapeno peppers. In a third, illnesses were linked to an item that
contained fresh jalapenos and tomatoes. Other clusters are under active
investigation. At present, the information indicates that jalapeno
peppers and serrano peppers grown, harvested, or packed in Mexico are
the cause of some clusters and could be a major food vehicle for the
outbreak. The U.S. Food and Drug Administration is advising consumers
that jalapeno and serrano peppers grown in the United States are not
connected with the current Salmonella Saintpaul outbreak and consumers
may feel free to eat them without concern of illness. By themselves,
tomatoes cannot explain the entire outbreak, nor do jalapeno peppers
explain all the clusters. The outbreak appears to be ongoing, but with
fewer new illnesses each day. New, very active field investigations by
CDC in collaboration with state and local health departments, and FDA
tracebacks on jalapeno peppers and tomatoes are providing new
information almost daily. It appears likely that more than one food
vehicle is involved. Although rare, more than one food has been
implicated in foodborne outbreaks in the past, as observed in a group
of 1998 outbreaks traced to imported parsley and cilantro from a single
farm.
Conclusion
The current outbreak investigation of Salmonella Saintpaul is the
largest foodborne outbreak in the United States in the past decade. The
investigation has been especially complex, difficult, and prolonged.
The outbreak appears to be slowing, but we are not able to say with
confidence that the outbreak is over because of the reporting delay.
The event illustrates how a large and widespread outbreak can occur,
appearing first as individual cases, then as small clusters, and
finally with large numbers of persons becoming ill if a widely consumed
food is contaminated. It also illustrates the importance of existing
public health networks: the laboratories performing PulseNet
fingerprinting; the epidemiologists conducting the investigation; the
environmental health aspects of the outbreak; the multi-disciplinary
approach to the investigation; and the close communication and
collaboration among local, state, and Federal officials.
CDC is prepared to continue working with regulatory authorities,
state and local partners, food and environmental microbiologist
scientists, and the food industry to find long-term solutions to this
challenging problem.
Thank you again for the invitation to testify before you today. I
will be happy to answer any questions you may have.
The Chairman. Thank you, Dr. King. As you said, we do need
to go vote now. I think both of you have said something very
important, and that is that there is somewhat of a breakdown in
the public health arena oftentimes.
My wife is a family doctor, and every time we have one of
these outbreaks in the country, she laments the fact that so
many of our states have had had a breakdown in their public
health functions from budget cuts and other things. We now rely
on the Federal network more than ever, and that isn't the
purview of this Committee but it is certainly a problem for
this Congress.
The Members will be back to ask questions right after we
vote. I think there are two votes and so it should not be too
long. We will reconvene this Committee right after the
beginning of the second vote. We are temporarily in recess.
[Recess.]
The Chairman. We will reconvene this hearing. We don't have
any Members of the Minority here at the present time but we do
have their staff and I am sure they will be coming in and out
as we proceed. I don't want to delay the questioning, however,
any longer.
Dr. Acheson, as you have submitted this as part of your
testimony, we will make this chart part of the official record
of the hearing today.
Dr. Acheson. Thank you.
The Chairman. Dr. Acheson, I would like to begin my
questioning with you. Do your agencies measure the Salmonella
contamination of tomatoes or any product on a regular basis to
determine what the incidence rate, the background incidence
rate of contamination is?
Dr. Acheson. The FDA does what we call assignments in which
we will, over a period of time, sample certain types of produce
and other foods to develop data and information, particularly
if it is foods that we have had concern about. We do not have
an ongoing approach or process for gathering baseline data for
different types of food items or fresh produce so it is
targeted, depending on areas where we have seen problems in the
past typically.
The Chairman. So say we have now called out tomatoes, as we
have, and it was an erroneous callout, we believe, or was it an
erroneous callout by your agency?
Dr. Acheson. No. I think that is a very important point. As
Dr. King pointed out, there was a very clear, methodical,
scientific process by which CDC and the states reached a
conclusion statistically that it was tomatoes at which point--
--
The Chairman. Let me stop you for just a second, if I
might. You reached a statistical conclusion but you never found
any direct evidence, you have never found a contaminated
tomato. Is that correct?
Dr. Acheson. FDA has not found a contaminated tomato but we
have now, as you have heard, found contaminated jalapeno and
serrano peppers, so that is two food commodities, and we have
also found places where serrano, jalapeno peppers and tomatoes
have all passed through, distribution centers where they have
all----
The Chairman. They have common distribution points?
Dr. Acheson. Yes, common distribution points, and we have
also identified a farm where all three are grown. So the
possibility certainly exists that this was on more than one
commodity. We now know it is on two, so it could very readily
have been on three.
The Chairman. Well, I guess my point is, in future
testimony that we are going to hear today, we are going to hear
about risk-based inspection. Certainly certain commodities are
going to be at higher risk for certain pathogens than others.
Wouldn't it be good to sample and to know if we are having
higher incidence from different areas? Wouldn't that be a good
idea to do if we could?
Dr. Acheson. Our whole approach of inspections and sampling
and testing is based on risk. That is the whole philosophy.
That is the philosophy of the intervention part of the Food
Protection Plan, and likewise, where do you put your
preventative strategies based on risk. I mean, that is just
logical, common sense, good food safety practices, in our
opinion. I suspect what you are wondering is, should we be
doing some routine baseline sampling? If that is what you are
asking me of certain types of higher risk produce, and it is
certainly something that we have discussed internally, but it
is very resource-intensive. Certainly as new resources are
coming online in 2008, 2009, I think that is something that we
would seriously look at being able to do. But to do that on an
ongoing basis, to make it meaningful, it is resource-intensive.
The Chairman. I understand that, Dr. Acheson, but I think
that is one of the things that we are going to delve into more
and more as the hearing goes on today. Just this one outbreak,
it is reported in testimony that I read that is going to be
given here later in the afternoon, just this outbreak has
caused the tomato industry over $300 million in losses. It
caused 1,300 people to be off their job for an extended period
of time. Two or three have lost their lives. That deserves a
significant amount of the government's resources.
And so my question, I guess, is, is it not beneficial to
sample the products that we grow, find out regions, for
example? You know, we import an awful lot of our food from
other places these days. It is important to note there are
certain regions of Mexico that produce more outbreaks than
others. We have to start getting a handle on this, I would
suspect. So I invite your comment.
Dr. Acheson. Well, thank you. I couldn't agree more that
when you look at the societal cost of an outbreak like this,
which is really what you are discussing in terms of the
economic impact on the industry, and more importantly, the
economic impacts on human health and life sometimes in an
outbreak. Then when you ask those sorts of questions, clearly
FDA would wholeheartedly agree with you that that is an
important priority. Within the resources that we currently
have, we are not able to do the level of baseline testing that
you are suggesting. It is not that I am saying it is not a good
idea, it just simply isn't possible with the resources that we
currently have available to set up the type of risk-based
baseline testing of foods, both domestic and imported from
areas of concern or foods of concern based on public health
risk. It makes all kinds of sense to do that.
The Chairman. And so you agree that if the resources are
available, it would make sense to conduct some food-based risk
assessment throughout the food supply?
Dr. Acheson. Absolutely, and that is one of the things that
we are targeting to do in the Food Protection Plan from a risk-
based approach.
The Chairman. Mr. Mahoney.
Mr. Mahoney. Thank you, Mr. Chairman.
Dr. Acheson, Dr. King, thank you very much for being here
today. Let me start out by thanking Dr. Acheson for the time
that you spent with me updating me on this complex situation.
It was very illuminating. I think that what has happened is
that with the focus on national security and food security, I
think people are now starting to see that they are very related
to one another, and so I think the nation is very concerned. I
also think the nation is very concerned about the fact that we
need to protect our food, make sure that the product that is
being put on our family's table is safe, and part of that is,
how do we keep track of all this. But with the exciting news
that you just gave us, the breaking news, I didn't see it on
CNN but I am sure it is going to be soon, my first question is,
are we at a point now where FDA feels they can clear tomatoes
and take the overhang, the cloud off of tomatoes? Because as
you know, we haven't found tomatoes to be a problem, but at the
same time, you haven't exonerated tomatoes. And as a result,
there continues to be economic damage because there has not
been a clear statement on the part of the FDA that it is safe
to eat tomatoes again.
Dr. Acheson. What FDA has clearly stated, I hope, and if
not, I will state it again, is that tomatoes that are currently
being grown anywhere in the world, there is no evidence that
they are linked to the outbreak, whether they are Mexican
tomatoes or domestically grown tomatoes.
Mr. Mahoney. And so with this information, you are not
prepared to say that tomatoes weren't part of the problem?
Dr. Acheson. Not at all. No, I think that we did not find a
positive in tomato, as we have already heard, we have already
discussed, but there are plausible explanations of how the
Salmonella Saintpaul strain could have cross-contaminated both
tomatoes and peppers. As I said just a moment ago, we found at
least one farm that is growing serrano peppers, jalapeno
peppers and tomatoes, and we know there are other distribution
centers that they are going through.
Mr. Mahoney. Okay. Well, I think you understand that there
is a big difference between making a very clear statement as
opposed to saying it is okay to eat tomatoes today. Because I
think informed consumers are going to say, ``Well, it is only
safe to eat tomatoes today because we are not seeing the
incidents and the problem could still exist out there.''
Anyway, next question I have for you, the source of the
positive sample, what kind of standards do these growers have
down in Mexico? I mean, what food safety requirements do they
have?
Dr. Acheson. They, in order to import foods into the United
States, should be practicing good agricultural practices. That
is not a requirement, as I am sure you are aware; it is a
guidance. But it is the standard that we hold farmers, growers,
and packers to. If, when we inspect, we find that they are not
doing that or we find other evidence of problems, then we would
resort to putting them on an import alert.
Mr. Mahoney. When is the last time you inspected this farm?
Dr. Acheson. I don't believe we have ever inspected this
farm.
Mr. Mahoney. Is there a requirement for anybody to inspect,
the Mexican Government, any other agency within the U.S.
Government should be inspecting this farm?
Dr. Acheson. There is not a requirement that I am aware of
legally for us to inspect those farms. They essentially have an
obligation to produce safe food, and when they don't and we
find out about it, then the consequences are significant.
Mr. Mahoney. Now, when it got to the packing facility in
Nuevo Leon and then got packaged and went to McAllen, Texas,
was there any testing or is there any requirement to do any
testing when that food came into the United States?
Dr. Acheson. On a routine basis, no.
Mr. Mahoney. Okay. Are there any standards that people
operating in McAllen, Texas, the agricultural firm, has to meet
when they take that product in?
Dr. Acheson. Well, they need to be operating under whatever
good manufacturing practices or good agricultural practices,
depending where you are on the distribution chain of
agriculture versus manufacturing process and packing. So yes,
there are standards that they should be following.
Mr. Mahoney. Well, it is very clear to me, talking to my
growers, that one of the problems we have here is that the U.S.
growers have very exacting requirements, they have state
officials coming, checking out to make sure that they are in
compliance. But, people that are competing with them down in
Mexico are basically in this particular case, Mexico or
anyplace overseas, they are basically operating without any
oversight and they are shipping the same product competitively
into the United States. Am I correct to say that the only time
we get concerned about it is when we have a situation like this
and it goes back to a foreign source?
Dr. Acheson. Not at all, no. Last November, FDA put out a
series of legislative proposals, one of which is the
requirement for preventative controls for high-risk foods.
Fresh produce and, I have said before, tomatoes, leafy greens,
would fall under that very clearly because a high-risk food to
us is one that is repeatedly associated with serious illness.
Mr. Mahoney. And let me ask one last question. The costs
associated with the investigation in Mexico and our work down
there, who is paying for that?
Dr. Acheson. For our investigators? We are.
Mr. Mahoney. So there is no requirement on the part of the
Mexican Government or no interest on the part of the people
that are selling it in this country to help defray the cost of
this?
Dr. Acheson. All I can tell you is that the people down in
Mexico, the FDA investigators are under----
Mr. Mahoney. They are coming to work for you.
Dr. Acheson. Yes, absolutely.
Mr. Mahoney. And how many staff do you have in Mexico?
Dr. Acheson. Currently, I think there are three there. We
had a team of--it generally is a team of three or four each
time we have a visit but it varies.
Mr. Mahoney. And what are they doing down there? Are they
checking farms, or what is their purpose?
Dr. Acheson. This is now their third visit. They
essentially will go down there based on the traceback that we
got----
Mr. Mahoney. They are not headquartered there, they are not
located there?
Dr. Acheson. No, not at all.
Mr. Mahoney. I understand. Thank you.
The Chairman. Thank you. I anticipate that we will have a
second round of questions for this panel, so you will have an
opportunity for more questions.
Mr. Neugebauer, I would like to give the floor to you.
Mr. Neugebauer. Thank you, Mr. Chairman.
One of the things that we are talking about traceback in
this hearing, but traceback is an event that occurs after we
have a problem. One of the things that I think we have to look
at here as we address this issue is, what resources need to be
allocated for the prevention piece as well as building the
infrastructure for the traceback piece. Because if you are
focusing all of your resources on the traceback, you are really
not doing anything for food safety. I think that is one of the
things we need to stress to people that are watching this
hearing, traceback doesn't necessarily make the food safer
because traceback is about looking for the problem once it
happens. Obviously traceback does help us mitigate future
problems hopefully. In your estimation, what is the appropriate
allocation of resources? At the same time that we are
discussing this traceback, should we also be talking about the
structure of the testing and supervision and the measures that
we have in place to try to catch these problems before they
happen; but more importantly what are the things we can do to
mitigate them in the future?
Dr. Acheson. You made excellent points, and we recognized
some time ago the importance of prevention, which I think is
essentially what you are suggesting. You are far better at
preventing the problem in the first place then reacting to it
when it happens, and that just makes all kind of sense. To that
end, in November, we published a Food Protection Plan that
emphasizes prevention, intervention and response, the
importance of building in preventative controls up front,
understanding where the risks are, making sure that industry
understands what its responsibilities are, what sort of
mitigation strategies can be put in place, where those risks
exist. We requested new legislative authority to require
preventative controls for high-risk foods, to require
preventative controls for certain types of foods that were
particularly vulnerable to deliberate attack, and there were
eight other legislative proposals that are in there, not all
focused on prevention but certainly three of them are. Combined
with that, you are absolutely correct, the focus in past has
been heavily on reaction, of essentially reacting when
something bad happens. We have to get better at that. It is not
like we can ignore that. But there has been a deliberate shift
of focus with the new assigned food safety money for FDA in
2008 and what is in the President's budget for 2009 towards
prevention, and it is all about understanding how you build in
those preventative controls.
To that end, with tomatoes, we began last year something
called the Tomato Safety Initiative that we work with the State
of Florida and the Commonwealth of Virginia. It is still
ongoing. But we have learned things from that about growing
practices about potential problems, many of which have been
picked up by the industry, addressed and fixed. But there are
lessons learned in there for all of us because it is not just
Florida and Virginia that are growing tomatoes. We have talked
about tomatoes being grown in other countries. What we learn
from our domestic situation could easily be applied, and it is
all down to prevention. So the goal is for much more effort,
energy and resources to be put into prevention, it has to be
combined with a risk-based inspection and sampling process, a
system for early detection of problems and then a rapid and
effective response system when something does fall through the
cracks.
Mr. Neugebauer. Dr. King, do you have a reflection on that?
Dr. King. I would certainly agree with that, and it is
about the farm to the table, that public health emphasis needs
to be across that whole spectrum. You did talk about resources
and I think it is very important the states are well resourced.
I think in some instances, their public health systems are not
as well resourced as they should be and that adds to the
difficulties that they have.
Mr. Neugebauer. One quick question: When we have these
occurrences and we are beginning that traceback period, what is
the appropriate amount of information that we can give to
consumers? Not to cause this panic that we saw where just
basically unilaterally taking tomatoes completely out of play
when we, A, didn't know whether it was tomatoes, and B, we
didn't know where they were coming from. What do we need to do
better about that so that we can address the issue but not
cause this fairly substantial monetary loss for the industry,
plus the lingering effects of such a wide--I think what
probably scared the market more than anything was that we just
took the product almost completely off the market, if not
entirely. That is a pretty big statement.
Dr. King. Yes, sir, that is a great question. It is all
about balance. It is about a balance of when do you give
information to the public to make good decisions. We talked
about 1,319 cases. We know obviously that there are many more.
There are thousands of cases involved here. How quickly do we
need to get out to the public some good information to inform
them so they can make good decisions about what they eat to
prevent further illnesses or possible deaths. So that is the
balance that we deal with. Unfortunately, in many of these
foodborne outbreaks, we don't find the etiology or the exact
cause of the infection during the outbreak. So early on when we
want to give warnings to consumers, that would be most helpful.
More often it is the rule rather than the exception that we
won't necessarily have a positive culture from a product. So
what we want to do is then rely on good epidemiology, good
surveillance, good statistical analysis that would say there is
a strong association with this food and this illness and try to
balance that with the messaging to the public.
Mr. Neugebauer. I see my time has expired.
The Chairman. Thank you, Mr. Neugebauer.
Mr. Etheridge.
Mr. Etheridge. Thank you, Mr. Chairman. Let me thank you
for holding this hearing and thank our witnesses for being
here.
As you probably know, North Carolina is a state that
produces an awful lot of produce, and one of the expanding
markets we have on the East Coast of growers and our folks
suffered tremendous adverse effects with the tomato, really
almost like an embargo really. So my question, Dr. Acheson, to
you is, during the traceback investigation, how frequently did
the FDA reach out to farmers and producers, and the second part
of that question, what kind of communication does FDA have
between FDA and the industry, folks who grow it here in the
United States?
Dr. Acheson. Yes, I understand what you are saying. One of
the things that we have learned from the recent outbreaks, and
particularly in some of the opening statements was the
importance of learning lessons from these situations. We
learned from the spinach outbreak that continuous, regular
communication with industry was not only helpful to us but it
was helpful to them and it was important. In this outbreak, we
have attempted to maintain regular conference calls with
industry leaders. Now, obviously we can't communicate with
every single grower, farmer in the United States. That is
simply not practical.
Mr. Etheridge. No, I don't mean that, but that is a very
general question with not much of an answer, because I can say
industry, that says one thing. I would kind of be interested to
know whether or not you contacted the states that are primary
growing states, California, Florida, Texas, North Carolina, New
Jersey, a host of other states. Did you interact with them? Did
we interact with those farmers?
Dr. Acheson. Yes.
Mr. Etheridge. Or did we just talk to someone who imports?
I guess my broader question should have been more specific.
Dr. Acheson. Well, the interaction with the industry, per
se, is typically with the trade associations, and that is the
way that we have operated, and if that is not adequate, then we
need to learn a lesson from that. That is on the industry part.
With regard to the states, we hold regular calls with
departments of health and we invite departments of agriculture
to be on those calls with us so we can share the information.
They are not just essentially a data dump, they are an
opportunity for Q&As, and every time we go out with these, we
ask if anybody has any questions, and it is not like somebody
can't pick up the phone if they think we have some really
important information and we don't think FDA has it, they are
not asking us for it. That may be just our ignorance that they
have something that could really help, and I would advocate for
them, pick up the phone, call us rather than saying well, you
never asked me.
Mr. Etheridge. Who would they call? Do you have an
ombudsman where you can call? Is there a number that they are
given or just call FDA?
Dr. Acheson. There are many numbers. I mean, almost anybody
in the agency who----
Mr. Etheridge. I hate to interrupt you, but that is sort of
my point. If there is not an entrance point where you could
call, it would be helpful for folks to know that because they
may have good information that would help.
Dr. Acheson. There are a number of direct avenues through
the Center for Food Safety and Applied Nutrition, through the
Office of the Commissioner. A lot of people call me directly.
In fact, the Commissioner of Agriculture for North Carolina
called me directly and I have spoken to him a number of times.
He had specific concerns much along the lines that you are
suggesting and said, ``Okay, Dr. Acheson, what is going on, can
you tell me what is happening,'' and we had a good conversation
and he had some good ideas and some suggestions for the future.
That is what I am talking about. He was able to find me without
much trouble.
Mr. Etheridge. Dr. King, does the CDC have any procedure in
place in order to ensure that local and state agencies are
reporting the data in the same accurate and consistent way, so
that all of it comes in in a form that can be used?
Dr. King. Yes, sir. All the states now and some of the
counties and the cities actually use a system called PulseNet,
to post on the web results of pulsed-field gel electrophoresis
(PFGE) testing. PFGE is a standardized system where you
actually can take a sample of a bacteria that has been cultured
from a person and go through a procedure, put it in gel and
electrify it and get the DNA patterns and then put the results
on PulseNet where all the other states can see it at one time,
and so we have algorithms and we look at those. Last year we
had over 60,000 reports of cases from the states in which we
were able to do that, so states then are able to compare their
outbreak samples or their cultures collectively across the
country.
Mr. Etheridge. One follow-up, Dr. King. We talked a lot
about traceback. Is there any way within the data you are
collecting that you have an effective and consistent traceback
across the reporting data--where you can have an effective
traceback procedure?
Dr. King. Sir, that is really not in our purview. The CDC
is working in surveillance, it is working in outbreak
investigation, laboratory and analysis. A lot of what we do is
the epidemiology, obviously we share with FDA now on a daily
basis. That really helps inform them in terms of helping them
with traceability but that's really the FDA's job.
Mr. Etheridge. Dr. Acheson, do you have that kind of data
collection across the board that is consistent enough where
that traceback could be effective?
Dr. Acheson. Yes, our traceback system is very consistent.
I mean, it is FDA inspectors doing it, often with the
assistance of the states. We have activated the Food Emergency
Response Network, which is heavily driven by the states for
sampling, inspection. The states have done a lot of the
inspection part of this whole outbreak investigation.
Mr. Etheridge. Thank you, Mr. Chairman.
The Chairman. We are going to turn the floor over to Mr.
Costa, but Mr. Etheridge's question just begs, isn't there wide
variability between the states? California and Florida do
amazing jobs. Some states, I don't want to impugn anyone's
state so I am not going to say which ones I think are the bad
actors, but some states do a very poor job, don't they, Dr.
Acheson?
Dr. Acheson. Well, I am not going to impugn one state over
another either; but, what I can tell you is, when they are
doing inspections for FDA, they are doing them under contract
with us and they are doing them to a standard----
The Chairman. But do you then do those inspections in those
states that don't have an apparatus?
Dr. Acheson. Yes. I mean, essentially we are using states
to leverage resources because they are on the ground.
Mr. Etheridge. Mr. Chairman, I want to follow that up. How
many states do you have contracts with?
Dr. Acheson. I think it is 42.
Mr. Etheridge. Forty-two of the 50? Thank you.
The Chairman. Congressman Costa, thank you so much for
being patient with us when we did additional follow-ups. The
floor is yours, sir.
Mr. Costa. Thank you very much, Mr. Chairman. I appreciate
your and the Subcommittee's efforts on this very important
issue to ensure that American consumers have the very safest
food possible, and I believe by and large we do. You have a
very difficult job as implementers of the policy because you
deal every day in the venue of risk assessment versus risk
management and trying to determine how we can minimize the
risks to the degree possible, but realizing that you cannot
make it entirely risk free. I mean, there are the variables on
people's eating habits. Certain people prepare food improperly,
not cooked properly. Sometimes people eat foods that are beyond
the ``okay on the shelf'' credibility and they are consuming
foods that are way beyond their shelf life. So as you wear your
hat of risk assessment versus risk management, I have a series
of questions and I would like to focus with regards to the Food
and Drug Administration, and if the CDC would like to chime in,
you are welcome, but let us be quick because of my time.
I am very familiar, and of course, I have my own view on
how we ought to do this and improve it. It is H.R. 5904.
Congressman Putnam testified about it earlier on and we are
working with a lot of different interest groups to try to see
if we can get the sort of support to give you the additional
tools to ensure safety. When the tomato industry, which I think
has a pretty sophisticated traceback system, it was my
understanding that the FDA was reluctant to disclose too much
information on their investigation to the industry but you
navigated the distribution chain blind. Do you think that
played a role in prolonging the tracking process?
Dr. Acheson. No. First of all, we are bound by law in terms
of what we can share with industry.
Mr. Costa. So there is a statute that restricts the
information that can be shared with industry during an
investigation?
Dr. Acheson. Yes.
Mr. Costa. Okay. The tomato industry has developed very
detailed food safety guidelines for the entire supply chain in
coordination with FDA. You call it, I guess, CFSAN or whatever
the acronym is. The frontline investigators had little or no
knowledge about these standards and systems, I have been told,
that the coordination in there between CFSAN and your brain
trust, so to speak, and the actual investigators. What sort of
training do you give your investigators?
Dr. Acheson. In terms of their investigational capacity,
they get extensive training. In terms of investigating a
problem and what they are going to do out in the field, they
get a lot of training.
Mr. Costa. Do you think it would make sense to have some
additional training and oversight done by CFSAN to ensure that
the investigators are informed before they do a search?
Dr. Acheson. The Center for Food Safety and Applied
Nutrition, which is CFSAN, is involved in the training of
investigators and they work with the----
Mr. Costa. I understand it is not to the degree that it
should be.
Dr. Acheson. Certainly if you are raising a point that
could training be more extensive, it is certainly something
that we could look at.
Mr. Costa. In the recent traceback drill that you guys
performed in California or that was performed, it is my
understanding that they went from Jack in the Box to a farm to
be able to trace in 35 minutes where tomatoes had come from.
Five other drills they ran, the longest traceback took 5 hours.
Why do you think it took you folks so long to do your own FDA
traceback?
Dr. Acheson. One of the interesting things about this
outbreak was that to start with, there were many sporadic
cases. They weren't clusters so there was no clear focus for
traceback. Then what we were learning is that in fact it was
not the major chains and the major industries, it was small
Mexican-style restaurants very often.
Mr. Costa. Of all your tracebacks nationwide that you
attempted, how many were unsuccessful in each step of the
supply chain? Do you have that number? If you don't, could you
provide the Subcommittee with that information?
Dr. Acheson. Certainly, I will. A number of the sporadic
ones that we were doing initially for tomatoes were
unsuccessful.
Mr. Costa. As you went through this chart earlier, there
was a contamination in jalapenos and then serrano peppers on
July 1. Why did it take until July 17 to remove the warning
from tomatoes, even though you thought the samples from the
jalapeno were a genetic match? It doesn't exonerate other
foods.
Dr. Acheson. Tomatoes were never exonerated from that
perspective.
Mr. Costa. So then it is proven guilty? You are guilty
until proven innocent?
Dr. Acheson. There isn't a question of guilt or innocence
here. We were operating----
Mr. Costa. When the bottom drops out of the market, it is a
real problem.
Dr. Acheson. Our mandate is to protect public health, sir.
Mr. Costa. I believe that.
Dr. Acheson. And we were responding to solid, scientific,
epidemiological data through a tried and trusted source from
professionals whose job it is to do that, and FDA was taking
that data, initiating the tracebacks. No question that they
were complex, that they were difficult, largely because it
wasn't the big chains, it was many small people who are not big
producers, not big suppliers. You have to go to every single
one of them, you have to get the records. They are often not
maintained electronically. You just simply cannot do the whole
thing in 5 hours when you are dealing with that kind of level.
Mr. Costa. Well, but the industry was able in the case of
the tomato industry in California, they were able to traceback
over five drills. The longest took 5 hours.
Dr. Acheson. I don't question that certain sections of the
tomato industry are capable of doing that, but I do question
whether all sectors of the tomato industry from the largest to
the smallest are capable of doing that. What I am trying to say
here is that some of the smaller players were some of the ones
that we were dealing with here. It was not necessarily the big
guys, who can do it all in 5 hours.
Mr. Costa. My time has expired, Mr. Chairman. I will save
the questions for the next round.
The Chairman. I have a housekeeping piece of business that
I have been told by counsel I have to do. I have to ask
unanimous consent of the Committee assembled that you be
allowed to ask questions since you are a Member of the full
Committee but not a Member of the Subcommittee, so without
objection, Mr. Costa will be allowed to ask questions at this
hearing.
Mr. Costa. Can I ask my questions now?
The Chairman. And, Mr. Costa, your time has expired.
Mr. Costa. Thank you very much, Mr. Chairman.
The Chairman. You are welcome. Thank you for the excellent
line of questions.
Dr. Acheson, I want to follow up. I spent 6 years in the
legislature, three of which were as Chairman of the Agriculture
Committee there, and I spent the entire 6 years on that
Agriculture Committee in the legislature and now my 6 years
here in Congress. In that period of time, I have asked a number
of questions about imports from other countries and how we can
in fact determine that they are safe for our public. Why do
other countries not have to abide by the same protocols that
our farmers here in the United States have to comply with? Many
times during those hearings, I have been told that there is
sampling done at the border. Today you have indicated to me
that there is no sampling done at the border.
Dr. Acheson. No, that is not what I said.
The Chairman. Okay. Would you like to elaborate on that,
please?
Dr. Acheson. Please. I didn't say there was no sampling
done at the border. If I said that, it was a misrepresentation.
There is limited sampling based on risk, based on those food
commodities where we have seen previous problems.
The Chairman. Do you do sampling for pesticides?
Dr. Acheson. Yes.
The Chairman. How much of the product that goes through the
border would you estimate is sampled on a percentage basis?
Dr. Acheson. A hundred percent of what is coming through
the border is examined electronically in terms of where it has
come from, whether we have concerns. About one percent of that
is physically examined by an inspector and about, I think about
half of that, a sample may be taken or maybe a little less in
terms of actually taking a sample to do some testing.
The Chairman. And of that \1/2\ of 1 percent that actually
get sampled, what things do you sample for, and would you
sample for everything that is known? I mean, would you be
sampling for E. coli, for pesticides, for DDT, for things that
are banned here in the United States?
Dr. Acheson. It is very much driven by the commodities and
the risk. There are certain types of foods where we know
pesticides have been a problem so they get sampled for that. A
case in point, we know we have had problems with inappropriate
use of antibiotics and other antimicrobials in shellfish and
other kinds of seafood, so for those, we would sample for that
typically. We have ongoing assignments sampling cantaloupe for
Salmonella because we have repeatedly seen problems with that.
So we don't look for everything in everything. It is targeted
and it is risk-based.
The Chairman. Sir, can you tell me, you said this is the
worst outbreak this decade. How long has your agency been
monitoring food safety in the United States? Let us start with
that first.
Dr. Acheson. Just a little over 100 years.
The Chairman. Okay. So you have been doing this a while.
Dr. Acheson. I haven't been doing it the whole 100 years.
The Chairman. So in your experience, say, in the last 20
years, we have encountered a number of food safety crises and
outbreaks in this country. You are saying this is the worst one
in the last decade. Can you tell me, of the foodborne outbreaks
that we have seen with different pathogens, whether they be
pesticide-related--I think Alar was a pesticide that we had a
problem with a few years ago. We have had several Salmonella
cases. We have had several E. coli cases, and your agency
doesn't do meat but that has been one of the areas of problems,
so both you and USDA and have had challenges with regard to the
areas of jurisdiction. Can you tell me how many, on a
percentage basis, would you suspect come from Mexico or other
countries versus domestically grown products?
Dr. Acheson. In terms of outbreaks?
The Chairman. In terms of outbreaks.
Dr. Acheson. Yes. That is a question that I would ask Dr.
King to help me answer because the CDC tracks outbreaks more
than FDA. But my experience is that I am aware of maybe two or
three that have come from south Central America. We had
hepatitis A on green onions. We have had Cyclospora on
raspberries. That was not from Mexico, that was from another
country. Not that many.
The Chairman. We had strawberries, that I remember.
Dr. Acheson. Well, it was originally thought to be
strawberries and then it turned out to be raspberries.
The Chairman. But that wasn't from Mexico?
Dr. Acheson. No, Guatemala.
The Chairman. Okay. Dr. King, can you elaborate on that
question?
Dr. King. We don't have too much information
internationally. What we are trying to do is have
standardization in some of the sampling internationally. We
have this PulseNet system that I have talked to you about that
is now becoming more global. China is looking to put it in.
Mexico has it. We also have a system called Global Salm-Surv,
which is also looking internationally so that we can see these
products. It would be good to know, are they having outbreaks
in other cities, in other parts of the world, and can we
actually compare those outbreak strains with what we are seeing
in the United States. A multi-state outbreak may be a multi-
country outbreak. We are not there yet but that is something we
are looking at down the road.
The Chairman. Dr. King, what was the substance of the
communications that CDC had with local officials conducting the
investigations?
Dr. King. Early on, New Mexico was the first source. That
was May 22 when they actually contacted us about 19 potential
cases with the same PulseNet identification. From that point
on, we talked to them frequently. Texas was involved. The
Indian Health Service was involved. We helped them design----
The Chairman. We are running over my time so let me further
define my question that might bore into exactly what I am
trying to get to. PulseNet has without question improved the
ability of scientists to identify foodborne illnesses and
outbreaks, no question about it. Scientists today can identify
outbreaks that never would have been identified a decade ago,
and people who thought they were just having the stomach flu,
we now know have been sick or whatever it is. However, it seems
to me that for PulseNet to work efficiently, a state should
input such information immediately rather than wait until they
think they have a cluster. I think we can all agree here today
that 2 months delay is quite a significant period of time. An
awful lot of folks can get ill, as we have seen, in that 2
month period of time. How is it supposed to work with PulseNet,
and during your daily calls with these public officials, did
any states question the hypothesis that tomatoes were the
vehicle for the outbreak, or can you provide data implicating
any other food product, and if so, when?
Dr. King. We have conversations with the states almost on a
daily basis. Certainly the 43 states were involved. We
constantly have communications with them through conference
calls. We have an ``OutbreakNet'' system where we talk to
epidemiologists across the country, where we compare notes, we
talk about hypotheses, we question each other, I think which is
healthy, in a rigorous way. Part of what the states need to do
in these case control studies where they are actually talking
to cases and match controls, that information needs to come
forward. Many states do that themselves. Over 90 percent of
these outbreaks that we see are all done by the states
themselves. We only are involved in a small percentage of
those. We are able to help them where we can. We are able to
send people in in large outbreaks like this where we had so
many clusters. There is variability in terms of the reporting
from the states. That is one of the areas that we would like to
be able to cut down on. How quickly states will put results up
on PulseNet, how quickly you get specimens from clinical
laboratories, how quickly they are able to handle them, doing
serotyping, do they save them and do them in lumps or do they
do them right away.
The Chairman. Well, I think that is part of the question we
are trying to bore in on, Dr. King, because in earlier
testimony, I can't recall if it was you or Dr. Acheson who
indicated to us that there was standardization amongst the
states. But now you are indicating that some states report very
quickly and some states don't, that there is not in actuality
uniformity in the protocols that the states comply with.
Dr. King. Yes, sir, there is standardization in terms of
the process of using PulseNet. Some states are able to report
it more quickly. Some delay in that. Some of them will not run
the samples quickly, they will do it in a bulk way.
The Chairman. That is exactly my point, sir.
Dr. King. But the procedure is the same in terms of
PulseNet. The amount of time that it takes them to do it is the
variability.
The Chairman. Well, that is my point, is that in California
or Florida, you might get that overnight. In another state,
Texas or Minnesota, it may take--and I don't know. I am not an
expert so I am not saying which ones and I certainly don't want
to offend a state, but since they are not here to represent
themselves, we will use them as an example. They might take a
longer period of time in which case people continue to get sick
and we really don't have the information that we need.
Dr. King. And I agree with you, and we talk to states and
ask them if they can decrease this amount of time. It is very
important. We can't stay 2 and 3 weeks behind in order to do
these outbreak investigations. I agree with you that we are
pushing states to try to do that in as rapid a way as possible.
The Chairman. Well, not only are we not being fair with the
public, who is becoming ill when there is an outbreak that
should have been reported but wasn't. We are not being fair to
the farmers for 3 weeks who are losing their potential to
provide their products to the market, but are being implicated
in something where they are absolutely innocent possibly.
Dr. King. I agree with that, Mr. Chairman.
The Chairman. Mr. Mahoney.
Mr. Mahoney. Thank you, Mr. Chairman.
Just a follow-up question to both of you. Has there been
any indication, have you found anything in your investigation
that would indicate that any tomato grower in the United States
had done anything that would warrant at this stage of the game
that there was any problem with what they had done as far as
growing tomatoes, packing tomatoes and delivering tomatoes?
Have you found anything?
Dr. Acheson. No.
Mr. Mahoney. So you haven't found any indication?
Dr. Acheson. No. As part of the process, we went down and
we inspected the farms in Florida. By the time we got there,
they were no longer in production, but we did not find
anything----
Mr. Mahoney. That there is a problem with contaminated
water supply or something like, I mean.
Dr. Acheson. We didn't find any problems. That is all I can
say. But they were not in production.
Mr. Mahoney. I mean, you understand that crop insurance
doesn't cover this loss. I mean, the estimate in my State of
Florida is about a $47 million direct loss to the growers. I
think $300 million is probably light in terms of what the total
impact is, but again, the biggest casualty here is consumer
confidence in our tomato industry. It appears from this
testimony I have heard today that what we have is a situation
where we have a two-tiered system. We have foreign growers that
operate under a completely different set of standards and
oversight than our domestic producers. I won't spend any time
talking about the inequality of that as far as cost and
competitiveness but certainly for public health, there has got
to be a lot of concern, which gets to my last question.
I think that it is clear that given the resources that you
have available to both of you at this point in time in your
respective organizations, I am confident that you did the very
best you could possibly do. But, I also am hearing that there
is potentially more that we could be doing. So my question is,
in a perfect world, given the expertise that you have, do we
need to take action? Is there more that we could be doing;
should we be doing more; do we need to give you more resources?
I mean, from your experience, Dr. Acheson and Dr. King, what
would you recommend to this Committee that we do to fix this
problem?
Dr. Acheson. There is unquestionably more that we need to
do. I think your point about the economic impact needs to be
addressed. The urgency of public health needs to be addressed.
The Food Protection Plan has a lot of suggested authorities
that we think we need and we don't have those. It is going to
require resources and clearly that is being addressed and it is
going to be ongoing. But it is not all about response. If you
are thinking about response from FDA's perspective, then
clearly examining ways to improve traceback, make it faster and
not just with the big producers but with everybody. It has to
be uniform. You talked about standards for domestic versus
imported. The requirement for preventative controls would go
some way toward that, and you know, frankly, we need to hold
everybody to the same standard whether they are domestic or a
foreign grower.
Mr. Mahoney. And do you have the resources necessary within
the FDA to do that, to implement that and to do that today?
Dr. Acheson. No, we don't. The new resources that we have
gotten will go a long way to begin to develop those once we
have the authorities. But, to actually implement them and
assure that they are being maintained, whether it be through
direct FDA inspection or third-party inspection with FDA audit
and oversight, that is not part of the current----
Mr. Mahoney. Do you feel that the FDA has the expertise and
the ability to implement such a system and to operate it
successfully?
Dr. Acheson. Yes, I do. I believe FDA has the knowledge,
has the system, but we need to do more. We need to hire more
experts, particularly in certain specific areas, produce being
one of them. We do have some produce experts. We need to hire
more.
Mr. Mahoney. Dr. King, do you have any thoughts in terms of
the CDC?
Dr. King. Yes, thanks. One of the things I wanted to
reiterate in terms of resources would be for the states. One of
the reasons that they were slow is not because they are
incompetent, it is because they went really flat out, and when
you have a lot of cases and all that work to do, they just
couldn't keep up. So there are resource issues within the
states. There is no question about that. I think this idea of
what we call infectious disease ecology, understanding how
agriculture and public health need to be linked over a
continuum and how the outcome is very positive that we both try
to achieve. We don't want to just look at cases in controls. We
want to be able to move upstream and we need industry support
to do that. We need their help. We need their understanding.
And I think one of the lessons learned for us that would come
out of this would be to have that kind of expertise as part of
putting this whole integrated strategy together and we would
look very much forward to doing that.
As far as CDC goes, we would like a better electronic
system where we could actually have data from the states that
would come in, do it quickly, for data from case control
studies to come in, where the analysis could be done more
quickly, could be done on a Web-based system. We would look at
that and potential iterations of PulseNet which would look at
microarrays, Luminex kind of platforms where it is more
accurate and quicker. That technology is available and we would
look forward to adopting that down the road.
Mr. Mahoney. Thank you, Dr. King.
The Chairman. We are going to have to move on. Thank you,
Mr. Mahoney.
Mr. Costa, if you have a couple burning questions since you
have been so patient sitting here, I would like to give it to
you. We have two witnesses that have flights to catch and so we
are short on time, and I also have to get two or three things
on the record for the staff. So I will turn it over to Mr.
Costa and ask for brevity.
Mr. Costa. I will try to be quick. Does the FDA currently
have the authority to institute mandatory regulations for high-
risk products or do you believe that Congress needs to give you
that authority?
Dr. Acheson. Do you mean mandate preventative controls? We
do not have authority to do that.
Mr. Costa. Okay. Because it seems to me, the problem where
you have very sophisticated industries like the tomato industry
in California or Florida is really--and you have the
traceability technology in place, that what we are really
talking about is the small truck farmer that maybe delivers to
a restaurant. Unless you have a receipt or some traceability,
you have no ability to--I mean, the larger producer that goes
through a wholesaler, goes through a co-op, a processing plant,
traceability there is pretty good, would you not agree?
Dr. Acheson. Yes, but you need to hold everybody to the
same standard. I think that is what you are suggesting.
Mr. Costa. And you believe we ought to do that?
Dr. Acheson. Right, for preventative controls, absolutely.
Mr. Costa. There are other questions, but for the sake of
time, I will defer and thank you again, Mr. Chairman.
The Chairman. Congressman Costa, maybe we could submit them
in writing and get a response.
Mr. Costa. Yes, I will do that.
The Chairman. Thank you very much.
Dr. Acheson, We need to clarify, because we think there is
confusion in the testimony, whether or not you have found
tomatoes on the farms where the peppers have been implicated,
whether they actually grow those on those same farms as the
peppers that have been implicated.
Dr. Acheson. Okay. If we could go back to the diagram, I
will try and explain it. The red box that is furthest away from
me is a farm where the pepper that we found in McAllen, Texas,
pepper samples. That is where that went back to when we traced
it back, so the positive pepper samples went back to that farm.
That farm grows tomatoes and peppers. The farm that I talked
about today is a different farm. It is lower down on the chart.
That farm grows just serrano and jalapeno peppers, it does not
grow tomatoes. Both of those farms are going through their
distribution system through one distribution center that is in
the middle of the chart with a circle around it. So there is at
least one farm that is growing all three and there is at least
one distribution center that all three are passing through.
The Chairman. Let me bore in on that question. In the farm
that has grown all three, did you find positive samples at the
farm or at the distribution center?
Dr. Acheson. We found the positive sample in a jalapeno
pepper at a distribution center in Texas. We visited that farm
and there are samples that are pending in the lab from that
farm.
The Chairman. Okay. So to date, we don't have a positive
implication directly to a tomato on either one of those
properties? There were tomatoes grown on that property. That
property shipped to a distribution center and you have found
contamination at that distribution center?
Dr. Acheson. We have not found contamination at the
distribution center in Mexico. We found contamination at the
distribution center in Texas, and I think your point is that
have we found a positive Salmonella Saintpaul isolate on the
farm that is growing all three. To this point, no, but those
samples right now are in the lab being analyzed, so that could
change.
The Chairman. The Committee will be very interested in that
outcome.
Dr. Acheson. Absolutely.
The Chairman. Thank you. Go ahead.
Mr. Mahoney. Just to clarify, I thought you said that in
the box furthest away from you, that you had found
contamination or Salmonella in the water. Did I misunderstand
that?
Dr. Acheson. The box in the middle of the chart that has a
hand-drawn red circle around it, that is the farm where we
found contamination in the irrigation water and in a sample of
serrano peppers.
The Chairman. Dr. Acheson and Dr. King, I am going to have
to fast-forward because we have other panelists who have to
testify and catch planes, but I am going to ask you to submit
to some requests. Would you please provide the Committee with
the criteria and communications procedures used by your
agencies to communicate risk and issue alerts? And second of
all for Dr. Acheson, would you please provide the Committee,
when did you first learn that jalapenos were being considered
by CDC as a potential source for the outbreak? And finally, for
Dr. King, could you please submit to the Committee the criteria
used by CDC in conducting the epidemiological and traceback
investigations? Those three things, the Committee needs further
clarification on the exact procedures. We won't take up
Committee time to do that today but I want to thank you both
for your testimony and I appreciate you being here with us
today.
Dr. Acheson. Thank you.
Dr. King. Thank you very much.
The Chairman. Now, we are going to deviate a little bit
again and we are going to ask that a panelist from the fourth
panel join panel number three. Would Dr. Michael Osterholm
please join panel number three? And I will call that panel up
for questioning now.
We would like Mr. Anthony J. DiMare, Vice President of
DiMare Homestead Inc., DiMare Ruskin Inc. and DiMare Johns
Island, Inc., of Ruskin, Florida, to come forward; Mr. Henry
Giclas, Vice President of Strategic Planning, Science and
Technology for Western Growers Association of Irvine,
California; Mr. Bryan Silbermann, President of the Produce
Marketing Association, Newark, Delaware; and Mr. Thomas E.
Stenzel, President and CEO of United Fresh Produce Association,
Washington, D.C., to please come forward. I am sorry if I
butchered your names. I typically do that.
Dr. Osterholm, I know you are blazing a trail to a plane.
We are going to let you testify and then if you need to go, we
will excuse you after your testimony. If you can stay, we are
happy to have you.
Dr. Osterholm. Mr. Chairman, I can stay for another hour.
The Chairman. Dr. Osterholm, please go ahead and proceed
with your testimony and then we will go next to Mr. DiMare and
down the line as I read your names off today.
STATEMENT OF MICHAEL T. OSTERHOLM Ph.D., M.P.H.,
DIRECTOR, CENTER FOR INFECTIOUS DISEASE RESEARCH AND POLICY;
DIRECTOR, MINNESOTA CENTER OF
EXCELLENCE FOR INFLUENZA RESEARCH AND
SURVEILLANCE; PROFESSOR AND ADJUNCT PROFESSOR,
DIVISION OF ENVIRONMENTAL HEALTH SCIENCES, SCHOOL OF PUBLIC
HEALTH, MEDICAL SCHOOL, UNIVERSITY OF MINNESOTA, MINNEAPOLIS,
MN
Dr. Osterholm. Thank you, Mr. Chairman. My name is Dr.
Michael Osterholm. I am the Director of the Center for
Infectious Disease Research and Policy at the University of
Minnesota, and for almost 30 years I have been involved in the
area of foodborne disease epidemiology, having served many of
those years as the State Epidemiologist at the Minnesota
Department of Health and have led a number of complex large
foodborne disease outbreaks including that involving produce
over that time.
Today I have submitted my written comments in detail to you
about the issues that we believe are relevant to this
discussion you are having today. I think the discussion we have
had to date here this afternoon has been very helpful. With
that, let me make a couple of specific comments that I am sure
the rest of the panel will address and I think really go the
heart of some of the issues that you have.
Some of you are aware that as early as the first part of
June, I raised questions about the conduct of the investigation
that was undergoing examination at that time in terms of the
Salmonella Saintpaul. Let me make it clear that at no time was
I challenging the issue that tomatoes might be involved but if
we in fact would ever find the source of those using the
techniques that we are. I would submit to you today and having
been involved with outbreaks with multiple vehicles from over
multiple periods of time from the same farms that it is very
likely that this could represent multiple vehicles. I think
that statements today suggesting tomatoes are not involved are
very premature, and that in fact this very well could be an
outbreak that involved multiple vehicles over multiple periods
of time which made it much more confusing. I believe those
answers will be forthcoming. I believe that we will learn
specifically whether or not there were three, two or four
different vehicles involved and I would urge that all of us
take a breath in the sense of saying we need the information.
Clearly public health owes that to all of us here but that in
fact you have to be very careful about making the conclusions
that it is just peppers.
I would add that I must, Mr. Chairman, at the risk of a
friendly amendment to your comments, I come from the great
State of Minnesota. Our health department has pioneered many of
the techniques used today, and in fact, we have the fastest
turnaround of any state in the country for both interviews and
pulsed-field gel electrophoresis submission, and I would
daresay that we are very proud of that point.
The Chairman. The Chairman of the Committee and all the
rest of the delegation probably would admonish me as well, and
I accept it.
Dr. Osterholm. I am sure Representative Peterson will be
very pleased to hear that, sir.
Having said that, I also want to point out to you though
that I think that given this cause issue, we have more to do,
but I don't think that this outbreak has necessarily provided
any wrong information yet. It may have provided incomplete
information but I think we are going to learn more about that.
The next thing I would address here, and I heard this
comment made multiple times today. As someone who has spent the
better part of their career in the area of foodborne disease
epidemiology, I just have to say I don't know where we come off
or where we have the data to support that we have the safest
food supply in the world. I would suggest we have the world's
food supply, and the fact being is today if you look at any
item, whether it is processed or non-processed foods, your
Nutragrain bar that you think of as a domestically produced
item in any one day may have ingredients from ten different
countries in it. I could go through a whole laundry list of
products. So the point being today is that we do have an
international food supply. I think you have heard already here
in this hearing that the FDA has a very limited ability to
address the ingredients or food products coming into this
country relative to what they can do of what is processed or
grown within our borders. I think this is an important
consideration that we all need to talk about.
Having said that, also I think we have to talk about the
industry. As someone who has been very involved with foodborne
outbreaks and has actually worked closely with the industry, I
don't know if it is the 95-9 rule or the 99-1 rule or the
99.1.01 rule but I have never seen any food commodity produced
yet for which everyone within that particular domain has a
stellar operation. There are many organizations in this country
that have suffered because the least of their producers was the
one that caused the outbreak. I think one of the things we have
to address is not just a blanket statement that the industry
has done this or the industry has done that. I actually
represent a company that is a major supplier of bagged produce,
lettuce and so forth, and to date, they have never had a
documented foodborne outbreak in 20-some years of production.
They are an example of a company that has done it very well and
done it right. But just down the road, one of their competitors
was responsible for the spinach outbreak that occurred 2 years
ago. So I think we have to be very careful about this, and I
know our industry representatives will make that point, I am
sure, that we have to assure that the least of us have the
standards that are very important.
The next area of comment here is, I think we have some
confusion going on with the difference between what we call an
epidemiologic association and traceability. This outbreak is
not about traceability. It is not. This outbreak was about an
association, meaning the public health agencies, the state and
local health departments together with the CDC, did they do the
appropriate investigation to determine this is the likely
source of this, meaning this food item as a class, as a
category. Once that is established, or if it is not established
in the minds of reasonable people you can argue it wasn't
established, then that information goes to the FDA, and I have
seen a constant discussion of the failures of the FDA in this
outbreak investigation. I just want to point out that if this
product really isn't associated with tomatoes, which again I
think we all have to reserve judgment on, that is a failure of
the up-front part of the investigation of the CDC and the state
and local health departments. That is not an FDA issue. Our own
Minnesota Department of Health, which was the group that found
the first major association with jalapeno peppers and the large
restaurant outbreak in the Twin Cities, and actually fingered
the location of where that ultimate positive came from and did
determine jalapeno peppers were involved, basically did that
entire investigation a little short of 10 days, tracing it back
to one of three farms in Mexico in addition. So in fact, that
is the kind of information that is very important. Once that is
established, then we go to traceability. Then we say okay, if
we do in fact have peppers, where do they come from. My
original criticism of this outbreak investigation as our group,
the investigations I led, actually determined that in the first
three outbreaks in this country due to tomatoes and all of them
were locally and domestically grown tomatoes, required us to
not only look at the tomatoes where the cases brought them but
the people or the controls, because tomatoes do get repackaged
and resorted, and that has changed over time. All we were
pointing out was, you have to trace them all back to basically
then find out where the preponderance of tomatoes came from.
And so I just want to point that out because I keep hearing
that this is about traceability. I have yet to see an outbreak
investigation where we could not determine the source when we
had an association because of a lack of traceability
capability. Some, we have had a much harder time doing. Some,
we haven't had the greatest clarity, meaning it was an absolute
perfect bull's-eye hit, but on a whole, this is not about
traceability, this is about can we find it in the first
instance and associate it.
The next issue is risk-based testing. We cannot test our
way out of this problem. Testing a product to a certain degree
isn't meaningless but almost, and the reason I say that is
because testing is based on the statistical probability you are
going to find it in a product. We have oftentimes implicated a
product epidemiologically, meaning that the data were clear
that people were getting sick eating this product, people not
getting ill were not eating the product, and it still took us
weeks and weeks to find it. I remember one particular example
which had nothing to do with produce but some years ago,
because I got really panned in the media by the dairy
industry----
Mr. Mahoney [presiding.] Dr. Osterholm, you are going to
have to speed it up.
Dr. Osterholm. I know. I am looking at my clock here. I
just have 1 minute left.
The point being is that we actually implicated cheese in an
outbreak of Salmonella infection and they couldn't find it in
this cheese for a period of 5 weeks and then one day a
laboratory in Canada happened to be testing some of the cheese
and found it. The point being is testing doesn't necessarily
tell you it is there or doesn't tell you it is there.
And the finally, the last point I just want to make, the
real issues around this is what happens at the state and local
health departments with the CDC, and this is about disease
surveillance and outbreak investigation. Today less than a
quarter of the clusters that we find through PulseNet, these
clusters of cases, do we ever find a source of why they
occurred. Today we have a system out there that is largely
broken at the state and local health department level where
this disease surveillance occurs. In my written testimony, we
provide great detail how we can fix that at a cost that would
be just a small percentage of any one of these large outbreaks
for the country. I think if I would urge you of anything today,
one of the great services you could do is help forward that
part of the agenda. Then the gentlemen sitting to my right
would very rarely find themselves in this position of we have a
possible situation but we don't know what it is, therefore,
everybody is in limbo. What they need, what they deserve, what
the public deserves are quick answers with quick identification
of what the problems are and then rectifying those problems in
such a way as to have a minimal impact on both the food supply
but most of all meaning that there is an unsafe food in the
distribution center.
Thank you very much.
[The prepared statement of Dr. Osterholm follows:]
Prepared Statement of Michael T. Osterholm Ph.D., M.P.H., Director,
Center for Infectious Disease Research and Policy; Director, Minnesota
Center of Excellence for Influenza Research and Surveillance;
Professor and Adjunct Professor, Division of Environmental Health
Sciences, School of Public Health, Medical School, University of
Minnesota, Minneapolis, MN
Chairman Cardoza and Members of the Subcommittee, my name is Dr.
Michael Osterholm; I am the Director of the Center for Infectious
Disease Research and Policy and professor at the University of
Minnesota. Prior to my current position, I served for almost 25 years
in various roles at the Minnesota Department of Health (MDH), including
15 years as State Epidemiologist. In that role, I led some of the
largest and most complex foodborne outbreaks in our country during the
past several decades and helped pioneer some of the cutting-edge
epidemiology and laboratory techniques in use in this area today. In
addition I'm joined in my testimony today by coauthors Drs. Craig
Hedberg and John Besser. Dr. Hedberg served with me at the Minnesota
Department of Health and is now a professor in the School of Public
Health at the University of Minnesota. He is an internationally
recognized expert in surveillance and outbreak investigation of
foodborne disease. Dr. Besser is a leading expert in the laboratory
aspects of foodborne disease agent identification and is at the MDH.
Today we are pleased to share with you our perspective on the
current outbreak of Salmonella serotype Saintpaul, particularly given
the role the MDH has played in identifying jalapeno peppers as a
vehicle for this outbreak; the significant problems in our food
delivery systems that can and should be addressed, such as insufficient
product traceability, inadequate food protection planning, and
inadequate inspection and traceback capacity at the Food and Drug
Administration (FDA) and U.S. Department of Agriculture (USDA); the
problem with the epidemiological methods used by state and local health
departments and the Centers for Disease Control and Prevention (CDC) to
determine what specific foods or other exposures are responsible for
outbreaks; and finally, what we must do to address these critical
issues if we are to change our current and inadequate foodborne disease
surveillance and outbreak investigation systems.
First, let us share our perspectives on the current outbreak. On
June 2, 2008, the CDC announced that it was collaborating with public
health officials in several states, the Indian Health Service, and the
FDA to investigate an ongoing multi-state outbreak of human Salmonella
serotype Saintpaul infections. At the time, they reported that an
epidemiologic investigation comparing foods eaten by ill and well
persons had identified consumption of raw tomatoes as the likely source
of the illnesses in New Mexico and Texas. Results of this investigation
could not identify a specific type and source of tomatoes. The extent
of the outbreak, as it was then recognized, included approximately 87
cases in nine states.
Almost 2 months, more than 1,300 confirmed cases in 43 states, the
District of Columbia and Canada and two positive jalapeno peppers
later, we appear to be moving towards the end of the outbreak. We are
just now beginning to understand how this unprecedented event occurred
and why new case illnesses continued for so long.
There has been a great deal of discussion during these past 2
months regarding the difficulties in tracing the source of tomatoes and
an increasing concern that the epidemiological investigation may have
implicated the ``wrong'' food item. There will be a proper time and
place for all of the details of this investigation to be thoroughly
reviewed to determine what we might have known when, and how we might
more effectively use this knowledge to improve our investigation the
next time. If there is one clear message today to the public health
foodborne disease professionals of our country, it is that our other
public health colleagues, government leaders, the food and agricultural
industries and the public are expecting us to answer with some clarity,
``What happened?'' The one great certainty of recent years' experience
in investigating large, multi-state foodborne illness outbreaks is that
there will be a next time and it could be as soon as tomorrow.
We are not here to point fingers as to what worked and what didn't
work in this outbreak, but rather to point out that there are effective
models for the investigation of complex foodborne outbreaks that can be
adapted to improve our ability to rapidly detect and respond to these
events now and to build our capacity to prevent such outbreaks well
into the future. The fundamental questions we all need to ask ourselves
are how much do we really care about foodborne illness and what are we
willing to do to change our current approaches in both the public and
private sectors? Are the public and private sectors willing to invest
in a public health system that can more readily detect and effectively
respond to these outbreaks? Why are we not using available food safety
technology, such as irradiation, to effectively pasteurize our fresh
food supply? While we don't expect to answer these questions today with
great definition, we must begin to address them head on.
In light of the current outbreak-related recommendations to avoid
certain kinds of tomatoes, there will no doubt be extensive debate
about how quickly and with how much certainty public health
recommendations such as this should be made. The Council to Improve
Foodborne Outbreak Response (CIFOR) is a multidisciplinary working
group convened to increase collaboration across the country and across
relevant areas of expertise in order to reduce the burden of foodborne
illness in the United States. The Council of State and Territorial
Epidemiologists (CSTE) and the National Association of County and City
Health Officials (NACCHO) are co-chairing CIFOR with support from the
CDC. CIFOR represents an important new effort to improve our foodborne
disease surveillance system by actively engaging local public health
agencies in the discussion with state and Federal counterparts. Because
the effectiveness of our national surveillance efforts depends on the
actions of local agencies, their participation in evaluating the
performance of foodborne disease surveillance and addressing its
weaknesses is critical. As noted in outbreak investigation guidelines
being prepared by CIFOR, ``While releasing premature and incorrect
conclusions to the public can be a disaster, and sounding the alarm
bell too often can lead to warning fatigue, it is a mistake to withhold
or delay the release of information that the public may need to protect
themselves. Public health agencies have an obligation to get
information to the public or others who need to know as quickly as
possible.''
We believe that there are significant problems in our food delivery
systems that can and should be addressed, such as insufficient product
traceability, inadequate food protection planning, and inadequate
inspection and traceback capacity at the FDA and USDA. However, in our
opinion this outbreak primarily highlights serious shortcomings with
our foodborne disease surveillance system and initial epidemiologic
investigations. As the name implies, foodborne disease surveillance is
the part of our food safety system involved with gathering of data from
people who have become ill with diseases that may be due to
contaminated food.
Foodborne disease surveillance is the single most powerful tool at
our disposal for the detection of unrecognized problems in our food and
water supplies, and yet it remains largely out of the public eye and
conspicuously underrepresented in national food safety planning. In a
sense, our surveillance system has become crippled by its own success.
Most of the foodborne disease outbreaks that have come to national
attention in the past few years would not have been detected at all 15
years ago. This has largely been due to the development of PulseNet,
the nation's molecular subtyping network. PulseNet was created by the
CDC in 1998 to track disease-causing bacteria such as Salmonella by
``DNA fingerprinting,'' using similar methods to those used to identify
people in criminal investigations. Unfortunately, PulseNet cannot
identify the source of an outbreak by itself. Its principle role is to
identify clusters of cases that have a high likelihood of having been
infected by a common source, such as a mass-distributed food item.
Another critical aspect to maximizing the effectiveness of PulseNet is
the time it takes to actually get patient bacteria isolates into the
public health laboratories and the time until the results are in the
hands of trained surveillance epidemiologists. In Minnesota, this
typically takes less than 3 days; in many states it takes up to 5 or
more weeks.
Once a cluster has been identified, an epidemiological
investigation is then required to determine if the cluster truly
represents an outbreak and to identify the cause or causes. The
essential problem with our current national system in our opinion is
that the epidemiological methods to determine the specific foods or
other exposures responsible for these outbreaks have not kept pace with
our ability to detect significant clusters of disease through PulseNet.
There are a variety of reasons for our limitations in this area. While
PulseNet is centralized and standardized, epidemiological
investigations occur at multiple jurisdictional levels, and there is no
generalized agreement on best practices. As such, there are great
differences in the ability of states to collect and analyze the basic
information needed to resolve outbreaks, which places intrinsic
limitations on the ability of CDC to investigate multi-state outbreaks.
This in turn limits the ability of FDA or USDA to pinpoint the sources
of contamination and to break the chain of transmission. It is at the
core level of exposure data gathering that we will focus our testimony
today.
The challenges of foodborne disease surveillance in the U.S.
Jurisdiction for foodborne disease surveillance in the U.S. is
based on individual state reporting rules. Across 50 states, more than
3,000 local health departments act with varying degrees of autonomy.
Last year at the Annual OutbreakNet/CSTE meeting, C.P. Kanwat from
South Carolina and Bill Keene from Oregon presented the results of a
survey of the states regarding the structure and practices of foodborne
disease surveillance programs. Results of this survey found that
gastrointestinal disease surveillance was the responsibility of local
agencies in approximately half of the states and was centralized in a
single state office in approximately a quarter of the states.
Surveillance was conducted by regional state offices in approximately
20% of states. The multiplicity of different models for conducting
foodborne disease surveillance makes it difficult to standardize
surveillance activities across the country. Imagine what it would be
like if our U.S. Weather Service was a hybrid system of local, state
and Federal agencies of varying resources and expertise and all using
different methods and models to predict, document and interpret our
weather. It would be a mess; to certain degree that is the system we
have for foodborne disease surveillance and outbreak response.
CDC aggregates surveillance on a national level and provides
consultation and coordination for multi-state outbreak investigations.
However, CDC lacks authority to independently investigate outbreaks
within a state, and while encouraging states to be active participants
in multi-state outbreaks, has limited resources to directly support
outbreak investigations. The primary mechanism that CDC has to respond
to outbreaks is the initiation of an EpiAid request by a state health
department. In response to an EpiAid, CDC can mobilize resources and
dispatch an Epidemic Intelligence Service (EIS) officer, or small group
of EIS officers to the state making the request. EIS officers are
epidemiologists in training. Over the years this has been a tremendous
resource for states investigating unusual outbreaks, outbreaks caused
by an unknown agent or in states lacking adequate resources or basic
expertise to conduct such investigations. However, the logistics of
dispatching one or a few EIS officers to a field location do not
address the primary need to rapidly conduct a large number of
interviews as part of the investigation of an outbreak of foodborne
illness. While participating in outbreak investigations is an important
part of EIS training, EIS officers do not always have the experience
and skills needed to lead a complex foodborne disease outbreak
investigation.
Because CDC has primary relationships with the states, it is also
limited in its ability to directly interact with the more than 3,000
local health agencies that in many states have primary responsibility
for conducting patient interviews. The result is that in many outbreak
investigations, local agencies are left out of the loop and may not
fully appreciate the importance of their individual efforts (or lack
thereof) to the overall outbreak investigation. Establishing effective
means of integrating local agencies into large, multi-state
investigations that are detected and coordinated on a national level is
a major concern.
From 2002-2005, 40% of E. coli O157:H7 outbreaks and 25% of
Salmonella outbreaks reported to CDC were multi-jurisdictional in
occurrence. Increasingly, these outbreaks are detected by the
identification and investigation of clusters of cases with identical
pulsed-field gel electrophoresis (PFGE) profiles. These profiles are
the fingerprint of the infectious agent that allows us to determine
their similarity and serve as the key data used in PulseNet. The
development of standardized PFGE protocols and the ability to transmit
and store digitized PFGE patterns has put PulseNet at the forefront of
pathogen-specific surveillance for Salmonella, E. coli O157:H7 and
Listeria. No longer do states have to send living cultures to CDC for
the purposes of comparison. Electronic image files can be uploaded to a
central server and shared with public health officials instantly,
around the country.
The active participation of public health laboratories can be seen
from the result of surveillance in 2005, when over 5,000 E. coli
O157:H7 patterns and almost 30,000 Salmonella patterns were uploaded to
PulseNet. These data and the subsequent analysis resulted in the
detection of 36 multi-state E. coli O157:H7 clusters and 152 multi-
state Salmonella clusters. The CDC was involved in 19 multi-state E.
coli O157:H7 investigations and 30 multi-state Salmonella
investigations. However, the food items responsible for transmitting
the infectious agent, known as a vehicle, were identified for only four
E. coli O157:H7 investigations (or 21%) and eight Salmonella
investigations (27%) (CDC data presented at 2008 OutbreakNet/CSTE
meeting by Dr. David Warnock).
The relatively low yield of these investigations is disappointing.
While some of these clusters may have represented the co-incidental
occurrence of organisms with a similar pattern from multiple unrelated
sources, others were almost certainly outbreaks for which the source
could not be identified. There are many reasons why an investigation
may fail to identify a common source. The first is the length of time
between when patients got sick and when the outbreak was recognized. In
a study of enteric disease timelines, known as the EDITS study and led
by Dr. Hedberg and conducted on behalf of CSTE, the average time
interval between onset of illness and subtyping by PFGE was 15 days for
E. coli O157:H7 and 18 days for Salmonella. Because a cluster is
defined as the occurrence of multiple cases caused by strains with
matching PFGE patterns, clusters may not be recognized until 3-4 weeks
after onset of illness. If interviews of cases are not initiated until
after the cluster is identified, these further delays mean cases are
being interviewed about exposures that may have occurred 4-6 weeks
earlier. Longer delays reduce the likelihood that cases will accurately
recall important details of where and what foods they may have eaten
before they became ill. Since the incubation period for E. coli O157:H7
and Salmonella infections may be up to a week, this represents a
considerable challenge to identifying the contaminated food item.
A final challenge to identifying the source of contamination is
that many public health agencies do not use a standardized exposure
questionnaire or collect detailed source information about food items
during initial interviews. It is very common to identify from which
restaurants and grocery stores food was obtained and also to ask about
consumption of food items such as chicken, ground beef or lettuce and
tomatoes. However, these are not always cross-referenced in a way that
would link a specific tomato to a meal at a specific restaurant--
information that is critical to tracing the source of contamination.
Systematically collecting detailed exposure information during early
interviews with cases is a critical need to improve the effectiveness
of our surveillance and outbreak investigation efforts.
Opportunities for improving foodborne disease surveillance.
The challenges we face in improving our foodborne disease
surveillance have been becoming increasingly apparent for some time.
The CDC, FDA and the CSTE have been working for a number of years to
define the problems and seek solutions. In 2001, the National Food
Safety System (NFSS) Project, Outbreak Coordination and Investigation
Workgroup published guidelines for improving coordination and
communication in multi-state foodborne outbreak investigations. These
were specifically developed to address the challenges of coordinating
large and complex foodborne outbreak investigations among multiple
states and Federal public health and food regulatory agencies.
While these guidelines targeted communication and coordination ``at
the top'' of the investigation, they appear to not have increased our
ability to engage local public health agencies in multi-state outbreak
investigations and to rapidly develop the critical exposure information
``at the base'' of the investigation.
While we fully support the effort of CIFOR, the multidisciplinary
working we discussed previously, we want to submit that there is a
natural conservatism in any large and complex system that resists the
adoption of the types of new practices we believe may be needed to make
effective use of the tools we now have available for foodborne disease
surveillance in the U.S., and to respond to the challenges posed by our
rapidly changing food systems. The tension between holding onto the
methods of the past and using effective new methods of the present are
seen in much of the discussions within CIFOR, and the development of
guidelines for investigating outbreaks. Drafts of these guidelines are
currently available for review and comment on the CIFOR website (http:/
/www.cifor.us/documents/CIFORGuidelines-draft.pdf).
Chapter 4 of these guidelines on foodborne disease surveillance and
outbreak detection contains a very thorough overview of foodborne
disease surveillance methods, strengths and limitations. This chapter
also describes model practices for routine surveillance and cluster
evaluation--the actions that led to the early detection of outbreaks
such as the recent outbreak caused by Salmonella serotype Saintpaul.
The reality of the current situation is that the practices used may
vary based on pathogen priority, the needs of a particular outbreak,
and on an agency's resources. These determinations are made on a state-
by-state and agency-by-agency basis. However, there are a series of
practices described that provide a more aggressive approach to
surveillance that we believe give us the best chance to rapidly detect
outbreaks and identify the source of exposure. Many of these are
practices have been successfully used by the MDH. These include
interviewing all laboratory-diagnosed cases when they are first
reported using a standardized form to collect detailed exposure
information when recall is the greatest, and as possible new exposures
are suggested during case interviews linked to an outbreak, to
systematically re-interview initial cases to uniformly assess these
exposures. We believe these should be adopted as best practices, and
that where resources limit the adoption of these practices, we must
find a way to build the infrastructure of our public health system to
make it possible.
Another key to the success of foodborne disease surveillance in
Minnesota has been the use of a dedicated group of eight to ten public
health students (four to five FTE's), known as ``Team Diarrhea'', to
serve as a primary resource for interviewing cases as part of routine
surveillance and outbreak investigation. The use of Team D fits very
nicely into the centralized system of foodborne disease surveillance
that exists in Minnesota. Moreover, since conducting interviews in a
timely manner is one of the rate-limiting steps in outbreak
investigations, we believe a series of regional Team Ds or a national
Team D would go a long way to providing precisely the real-time support
for outbreak investigations at the state and local levels that is so
sorely needed.
The benefits of Team D go far beyond providing a dedicated group of
interviewers. Because members of Team D are public health students at
the University of Minnesota, they receive valuable experience in
conducting surveillance that enriches their academic training
immeasurably. The graduates of Team D are now moving into important
food safety roles in public health and food regulatory agencies across
the country.
We believe the time is right to build on the success of Team D in
Minnesota and to invest in a major Masters of Public Health-level
training program that should include epidemiology and surveillance
methods, risk assessment and risk management, and overviews of the food
system from farm to fork. This training program should include service
on National Team D, to conduct interviews and support outbreak
investigations at state and local levels.
The model for such a training program currently exists at the
University of Minnesota, School of Public Health. In addition to our
academic tracks in Infectious Disease and Food Safety, the University
has a post-graduate certificate program in Food Protection that defines
the key curriculum for food safety, with course offerings available
through a 3 week public health institute, or online.
We bring this to your attention to demonstrate that we have the
capacity to rapidly scale up this training program and establish both a
National Team D to provide an immediate resource to rapidly conduct
interviews to support multi-state outbreak investigations, and a long-
term program to develop a new generation of food safety specialists
with applied training in outbreak investigations to work in public
health and food regulatory agencies and food-producing industries.
To accomplish this effort quickly and with expertise, we propose
that the University of Minnesota can be designated as the lead academic
institution to develop this new food safety training initiative and
that a consortium of other schools of public health be established to
replicate this training program under the University's leadership.
Within 1 year this program can be established and prepared to support
outbreak investigations across the country. Within 5 years it will
transform foodborne disease surveillance at all levels.
A frequent objection to the ``Minnesota Model'' has been the
additional resources needed to interview all cases of foodborne
diseases with a sensitive and specific questionnaire, conduct
laboratory testing on a ``real time'' basis, and routinely investigate
all clusters of disease. We don't know how much money is currently
being spent on foodborne disease surveillance nationwide, but a CIFOR
cost-benefit study is underway to answer that question. Our
understanding is that most of the nation's capacity is funded by the
CDC Epidemiology and Laboratory Capacity Cooperative Agreement, which
has had level or declining funding for the past several years. Many
states do not have any dedicated foodborne disease epidemiologists, and
some states have only a single part time laboratory worker to conduct
PFGE analysis. We believe that the amount of funds needed to improve
this situation nationwide is small compared to the consequences of
maintaining the status quo. The MDH, serving a population of more than
five million people employs four to five student FTE's to interview all
reported cases of foodborne disease in a timely and systematic manner
at a cost of approximately $100,000 per year. Minnesota has made a
greater investment in epidemiologists and laboratory workers than most
states and we believe the stellar record of disease detection and
outbreak response is a direct result. Extrapolating from the Minnesota
experience, we estimate that enhanced nationwide surveillance for
Salmonella, Shigella, Campylobacter, and E. coli O157:H7 disease would
cost between $25 million and $50 million additional per year
nationwide. To put this number in perspective, a single case of
hemolytic uremic syndrome, the direst consequence of E. coli O157:H7
infection, costs between $\1/2\ to $1 million in medical costs alone,
and a single death has been estimated to cost society approximately
$6.2 million. Based on these estimates, it would take very few
prevented cases per year to justify the entire investment.
We don't know how many cases of foodborne disease are being
prevented by our current system, or how many cases could be prevented
with enhanced surveillance. We do know that since 1998, hundreds of
millions of pounds of contaminated food have been removed from the
marketplace and destroyed or discarded as the result of these
activities and have included such varied vehicles as peanut butter,
ground beef, breakfast cereal, almonds, frozen pizza, and stuffed
chicken products. Surveillance has allowed us to identify unrecognized
problems in our food and water delivery systems that might continue for
years if not detected. Therefore, we believe it's safe to say that the
number of cases of disease prevented by our current surveillance system
is a very large number. Nevertheless, the consequences of these
outbreaks remain high, and as we have described most outbreaks are
probably not recognized or resolved. As we have seen during the past
several months and during the 2006 outbreak associated with fresh
spinach, industry suffered extraordinary losses during protracted
outbreak investigations. The cost of fixing our system is only a
fraction of what industry loses in a single outbreak caused by delayed
or inadequate investigation.
In conclusion, we do know how to greatly reduce foodborne diseases.
We believe that most food producers and distributors place high
priority on delivering safe food to our tables. Furthermore, quality
foodborne disease surveillance and outbreak investigation fundamentally
changes the economics of food production, leveling the playing field
between those that work hard to produce safe food and those that cut
corners. We must continue to improve food safety through better design
and implementation of our food safety systems, promoting the use of
food irradiation and improving the traceability of implicated products
when inevitable problems occur. With a minimal investment in foodborne
disease epidemiology resources and disease surveillance infrastructure,
we can greatly improve our ability to detect and respond quickly and
correctly to unexpected problems such as the Salmonella serotype
Saintpaul outbreak we are discussing today.
Thank you Mr. Chairman for this opportunity to share with you and
the other Subcommittee Members our experience and perspectives on this
important issue. I'm happy to answer any questions you or the
Subcommittee may have.
The Chairman [presiding.] Thank you, Doctor.
Next up we have Mr. Anthony DiMare, Vice President of
DiMare Homestead Inc., from Ruskin, Florida. Mr. DiMare,
welcome. Thank you. The floor is yours for your testimony.
STATEMENT OF ANTHONY J. DiMARE, VICE PRESIDENT, DiMARE
HOMESTEAD INC., DiMARE RUSKIN INC., AND DiMARE JOHNS ISLAND
INC.; MEMBER, BOARD OF
DIRECTORS, FLORIDA FRUIT & VEGETABLE ASSOCIATION; PRESIDENT,
FLORIDA TOMATO EXCHANGE; MEMBER, BOARD OF DIRECTORS, UNITED
FRESH PRODUCE
ASSOCIATION, RUSKIN, FL
Mr. DiMare. Thank you, Mr. Chairman. Good afternoon,
Members of the Subcommittee. My name is Tony DiMare. I am Vice
President of DiMare Homestead Inc., DiMare Ruskin Inc. and
DiMare Johns Island Inc. in South Carolina. I am pleased to
have this opportunity today to address this group.
The DiMare Company is an 80 year old family-owned produce
company that grows, packs and ships tomatoes and other
vegetables from seven states across the United States. And I
must say, in the 80 year history of our company, we have not
had any foodborne illness relating back or tracing back to any
one of our farms in that time period.
I represent the third generation of my family to carry on
our produce business. I am a past Chairman of the Florida Fruit
and Vegetable Association and currently serve on its executive
committee and Board of Directors. I recently was elected to the
United Fresh Produce Association Board of Directors. I also
serve as President of the Florida Tomato Exchange and I am
former Chairman of the Florida Tomato Committee and the Florida
Tomato Growers Exchange. I was also appointed in 2002 to the
inaugural USDA Fruit and Vegetable Industry Advisory Committee.
Today I want to speak to you about our company's food
safety program, Florida's new mandatory food safety regulations
for tomato production and how DiMare Company was affected when
the CDC and FDA singled out tomatoes in the Salmonella
Saintpaul outbreak.
Food safety is at the forefront of everything we do day in
and day out at the DiMare Company. Not only do our customers
demand it, today's consumers expect that fresh produce they buy
at the supermarket or eat in a restaurant is safe and
nutritious. Simply put, ensuring food safety is the right thing
to do. From our farms to our packing facilities and
distribution centers, the food safety team at the DiMare
Company works diligently to ensure all products are maintained
in a food-safe environment at every stage of the process.
Our stringent internal food safety program includes monthly
facility audits and mock recalls throughout the year. Audits by
third-party companies ensure our program exceeds industry
standards. All DiMare fresh locations are audited twice a year
by the American Institute of Baking and have received the
highest scores possible. Each of our farms is audited by Primus
Labs and Davis Fresh. In addition, we routinely test our
fields, facilities and all water sources for pathogens. We
follow good agricultural practices in our fields and best
manufacturing practices in our packing facilities.
Our company has invested significantly in technology and
personnel to ensure product traceability. All DiMare Company
produce can be traced back to the grower and all produce
originates from either DiMare farms or growers who participate
in our food safety program.
Not only is the DiMare Company an industry leader in food
safety, the State of Florida is as well. On July 1 of this past
year, Florida became the first state in the country to adopt a
comprehensive food safety program with mandatory government
inspection and audits for tomato handling, production and
packing. Other states have inquired about the program as a
model. The program includes annual registration of all
producers, packers and repackers of tomatoes in Florida. It
also requires regulatory inspections and audits by state
inspectors from the Florida Department of Agriculture and
Consumer Services.
Our industry was shaken to the core in June when the CDC
announced that tomatoes were a suspected source of the
Salmonella outbreak and the FDA issued a broad advisory for all
consumers to avoid eating certain types of tomatoes. Shipments
ground to a halt. Tomatoes were left in the fields, in the
packinghouses and on trucks that were turned away by our
customers. More than a week went by before the FDA cleared 19
Florida counties to ship tomatoes. By then, however, consumers
were too confused and were reluctant to resume buying tomatoes.
Severe losses were incurred all along the distribution chain.
Early on, our sales were down as much as 60 percent and
business has been slow to pick up. Today our repack operations
are still off by approximately ten to 20 percent.
Adding to our frustration during the traceback was the FDA
and CDC's reluctance to turn to industry for help in
understanding and identifying distribution channels, knowledge
they clearly lacked. Tapping into industry expertise early on
would have gone a long way in speeding up the traceback. More
cooperation is clearly needed in the future.
In conclusion, even though the FDA has announced that all
tomatoes are safe to eat and has focused its attention on other
produce, we urge both FDA and CDC to completely clear Florida
tomatoes as a potential source of the outbreak. In addition, we
are calling on these agencies and others to sit down with
industry to determine how the investigation and traceback
process can be improved. Hard questions need to be asked and
lessons must be learned from this outbreak so that a similar
situation never happens again.
Looking ahead, we don't know how long it will take for
consumer confidence in fresh tomatoes to rebound. What has
transpired over the past 2 months is sure to affect our
business into next season. As an industry, we are strongly
committed to taking whatever proactive steps are necessary to
ensure Americans know they are consuming the safest, healthiest
and most nutritious fresh produce possible.
I want to again thank the Committee and Chairman Cardoza
for this opportunity to speak to you today.
[The prepared statement of Mr. DiMare follows:]
Prepared Statement of Anthony J. DiMare, Vice President, DiMare
Homestead Inc., DiMare Ruskin Inc., and DiMare Johns Island Inc.;
Member, Board of Directors, Florida Fruit & Vegetable Association;
President, Florida Tomato Exchange; Member, Board of Directors, United
Fresh Produce Association, Ruskin, FL
Good afternoon, Chairman Cardoza and Members of the Subcommittee.
My name is Tony DiMare. I am Vice President of DiMare Homestead
Incorporated and DiMare Ruskin Incorporated in Florida, and DiMare
Johns Island Incorporated in South Carolina. I am pleased to have the
opportunity today to address this group.
DiMare Company is an 80 year old, family-owned produce company that
grows, packs and ships tomatoes and other vegetables from seven states
across the United States. I represent the third generation of my family
to carry on our produce business.
I am a past Chairman of the Florida Fruit & Vegetable Association
and currently serve on its executive committee and Board of Directors.
I recently was elected to the United Fresh Produce Association Board of
Directors. I also serve as President of the Florida Tomato Exchange,
and I am a former Chairman of the Florida Tomato Committee and the
Florida Tomato Growers Exchange. I was appointed in 2002 to the
inaugural USDA Fruit and Vegetable Industry Advisory Committee.
Today I want to speak to you about our company's food safety
program, Florida's new mandatory food safety regulations for tomato
production, and how DiMare Company was affected when the CDC and FDA
singled out tomatoes in the Salmonella Saintpaul outbreak.
Food Safety and Traceability
Food safety is at the forefront of everything we do, day in and day
out at DiMare Company. Not only do our customers demand it; today's
consumers expect that the fresh produce they buy at the supermarket or
eat in a restaurant is safe and nutritious. Simply put, ensuring food
safety is the right thing to do.
From our farms to our packing facilities and distribution centers,
the food safety team at DiMare Company works diligently to ensure all
products are maintained in a food-safe environment at every stage of
the process.
Our stringent internal food safety program includes monthly
facility audits and mock recalls throughout the year. Audits by third-
party companies ensure our program exceeds industry standards. All
DiMare Fresh locations are audited twice a year by the American
Institute of Baking and have received the highest scores possible. Each
of our farms is audited by Primus Labs and Davis Fresh. In addition, we
routinely test our fields, facilities and all water sources for
pathogens. We follow Good Agricultural Practices in our fields and Best
Manufacturing Practices in our packing facilities.
Our company has invested significantly in technology and personnel
to ensure product traceability. All DiMare Company produce can be
traced back to the grower, and all produce originates from either
DiMare Farms or growers who participate in our food safety program.
Florida's Food Safety Program
Not only is DiMare Company an industry leader in food safety, the
State of Florida is as well. On July 1, Florida became the first state
in the country to adopt a comprehensive food safety program with
mandatory government inspection and audits for tomato handling,
production and packing. Other states have inquired about the program as
a model.
The program includes annual registration of all producers, packers
and repackers of tomatoes in Florida. It also requires regulatory
inspections and audits by state inspectors from the Florida Department
of Agriculture and Consumer Services.
The Outbreak
Our industry was shaken to the core in June when the CDC announced
that tomatoes were a suspected source of the Salmonella outbreak, and
the FDA issued a broad advisory for all consumers to avoid eating
certain types of tomatoes.
Shipment ground to a halt. Tomatoes were left in the fields, in the
packinghouses and on trucks that were turned away by our customers.
More than a week went by before the FDA cleared 19 Florida counties to
ship tomatoes. By then, however, consumers were too confused and were
reluctant to resume buying tomatoes. Severe losses were incurred all
along the distribution chain. Early on, our sales were down as much as
60 percent, and business has been slow to pick up. Today, our repack
operations are still off by about 20 percent.
Adding to our frustration during the traceback was the FDA and
CDC's reluctance to turn to industry for help understanding and
identifying distribution channels--knowledge they clearly lacked.
Tapping into industry expertise early on would have gone a long way in
speeding up the traceback. More cooperation is clearly needed in the
future.
Conclusion
Even though the FDA has announced that all tomatoes are safe to eat
and has focused its attention on other produce, we urge both the FDA
and CDC to completely clear Florida tomatoes as a potential source of
the outbreak.
In addition, we are calling on these agencies and others to sit
down with industry to determine how the investigation and traceback
process can be improved. Hard questions need to be asked, and lessons
must be learned from this outbreak so that a similar situation never
happens again.
Looking ahead, we don't know how long it will take for consumer
confidence in fresh tomatoes to rebound. What has transpired over the
past 2 months is sure to affect our business into next season. As an
industry, we are strongly committed to taking whatever proactive steps
are necessary to ensure Americans know they are consuming the safest,
healthiest and most nutritious fresh produce possible.
Thank you again for the opportunity to address the Subcommittee
today.
The Chairman. Thank you, Mr. DiMare.
Next up we have Mr. Giclas, Vice President of Strategic
Planning, Science and Technology for Western Growers.
STATEMENT OF HENRY L. ``HANK'' GICLAS, VICE PRESIDENT--
STRATEGIC PLANNING, SCIENCE AND TECHNOLOGY,
WESTERN GROWERS ASSOCIATION, IRVINE, CA
Mr. Giclas. Good afternoon, Chairman Cardoza, Members of
the Subcommittee. I am Hank Giclas, Vice President for
Strategic Planning, Science and Technology at Western Growers,
a trade association representing growers, shippers and handlers
of fresh fruits, nuts and vegetables in California and Arizona.
Our 3,000 members produce approximately half of the United
States total production of fresh fruits, nuts and vegetables.
We appreciate the opportunity to speak before you on the
Salmonella outbreak and its consequences for tomato growers.
The industry has a decades-long history of implementing
food safety improvements and has a commercial interest in
ensuring that only safe, wholesome, fresh produce is delivered
to our customers' tables.
The issuance of a consumer alert relating to red round
tomatoes has cost the California tomato industry millions of
dollars to date. The nature of the alert has precluded industry
from accessing established avenues of recourse such as
insurance programs to help with recovery. In addition, the lack
of an effective, timely ``all clear'' message from public
health authorities, a formalized restorative campaign for the
commodity and the continuing implication of additional
commodities have eroded consumer confidence such that losses
are likely to increase. Keep in mind, these negative impacts
are from growing regions that have not been implicated during
this outbreak.
On June 3, 2008, the FDA alerted consumers in New Mexico
and Texas that a salmonellosis outbreak appeared to be linked
to certain types of raw red tomatoes and products that may
contain them and warned consumers not to eat these products. A
few days later, the FDA expanded its warning to consumers
nationwide. They did communicate that several areas had been
excluded as a potential source for suspect tomatoes but this
nuanced message was largely lost on buyers, who avoided
purchasing all tomatoes.
In a survey of Western Growers' tomato-producing members,
individual losses ranged from $400,000 to $3.4 million. They
are mostly due to lower market prices related to poor demand.
To date, our members have experienced nearly $13 million in
early season losses at the farm gate related to this advisory
on tomatoes. The grower-level losses multiply as you add the
economic losses sustained at other points along the supply
chain.
Consumer polls surveying attitudes about food safety found
that \2/3\ of consumers had stopped purchasing tomatoes and
that many consumers have changed their eating and buying habits
over the past 6 months because they are afraid they could get
sick by eating contaminated food.
Grower losses and waning consumer confidence are our
principal rationale for being here today. When FDA takes action
to issue a broad consumer warning, it is, for all practical
intents and purposes, an international recall for that
commodity, regardless of production area or variety. It calls
into question the offerings of all producers, handlers,
retailers and food service providers and causes immediate and
long-term damage to the marketplace. Today, months after the
outbreak began, we still have no conclusive food items
identified as the source of these illnesses, and for every
speculation as to potential products, there is a negative
marketplace reaction.
FDA has access to expertise that can help guide the agency
through the complexities of the produce supply chain quickly
and efficiently. It is imperative for FDA to establish an
incident command process, an outbreak team, if you will, that
includes industry experts that would be formally engaged from
the very beginning to assist the agency in their
investigations. True reforms, improvements and enhanced
protection of both public health and industry cannot occur in a
siloed fashion. We must work together. The declaration of
outbreaks, the management of traceback, the communication with
industry and the public must be reviewed and examined using
this outbreak and others as examples. We must look at effective
models such as the Minnesota effort that recently outpaced FDA
in the traceback on jalapenos.
Western Growers is here to ask that impacted growers be
made whole and for changes to be made in the way FDA and CDC
investigate and communicate during outbreaks. The industry
adopts measures constantly to improve the safety of our produce
for the protection of our customers, but what about our
protection? To exclude the industry from the investigative
procedures ignores knowledge and expertise that can be brought
to bear to help bring outbreaks to swifter conclusions.
Instead, our industry is left in ruins. We must be made whole
and a new, more transparent, more participatory communications
and investigative process must emerge from FDA and CDC.
I thank you for the opportunity to testify and look forward
to the questions.
[The prepared statement of Mr. Giclas follows:]
Prepared Statement of Henry L. ``Hank'' Giclas, Vice President--
Strategic Planning, Science and Technology, Western Growers
Association, Irvine, CA
Good afternoon Chairman Cardoza and Members of the Subcommittee. I
am Hank Giclas, Vice President for Strategic Planning, Science and
Technology at Western Growers. Western Growers is a trade association
representing growers, shippers and handlers of fresh fruits, nuts and
vegetables in California and Arizona. Our 3,000 members produce
approximately half of the United States total production of fresh
fruits, nuts and vegetables and are committed to ensuring that these
products are delivered safely to consumers, here in the United States
and abroad.
Western Growers appreciates the opportunity to speak before you on
the Salmonella outbreak and its consequences for our tomato growers. We
also want to highlight the status of ongoing efforts within the produce
industry to ensure safe food reaches the American table.
The industry has a decades-long history of implementing food safety
improvements to prevent both deliberate and unintentional contamination
of produce as it makes it way from the field to the retail store or
restaurant. We have a commercial interest in ensuring that only safe
wholesome fresh fruits, nuts and vegetables are delivered to our
customers' tables. As a result, industry is driven to constantly
improve and refine its own food safety programs and food safety defense
capabilities.
In addition, there are historical legal requirements, such as the
Perishable Agricultural Commodities Act and the Bioterrorism Act as
well as new governmental mandates and calls for industry action, for
example, the Produce Safety Action Plan and the more recent Food
Protection Plan, that have spurred industry improvements in the areas
of prevention and traceback; each integral parts of comprehensive food
safety programs. These efforts, conducted in cooperation and
consultation with FDA, DHS, USDA, state departments of health and
agriculture and food safety experts have resulted in greater awareness
of potential vulnerabilities, the creation of more effective prevention
programs, and the ability to respond more quickly to outbreaks of food
borne illness.
Despite these ongoing and significant improvements in industry food
safety programs and practices, the U.S. Centers for Disease Control and
the Food and Drug Administration appear to maintain a ``guilty until
proven innocent'' approach to the regulation of select commodities that
has manifested itself recently in sweeping ``consumer advisories'' that
confuse consumers and wreak havoc in both domestic and export markets.
The result is significant losses at all levels of the supply chain with
no demonstrable positive impact on consumer food safety. It is very
likely that the public health impact has been just the opposite, as
confused consumers abandon fresh fruits and vegetables in their diet in
response to FDA and CDC alerts.
The June 2008 issuance of a consumer alert relating to red round,
roma and plum tomatoes has cost the California tomato industry an
estimated 30 million dollars to date and has precluded industry from
accessing established avenues of recourse such as insurance programs to
help with recovery. In addition, the lack of an effective, timely ``all
clear'' message from public health authorities, a formalized
restorative campaign for the commodity, and the continuing implication
of additional commodities have eroded consumer confidence such that
losses are likely to increase. Keep in mind that these negative impacts
are from growing regions that have not been implicated at any time
during this outbreak. Nonetheless they have been painted with the same
brush by CDC and FDA.
Need for Indemnity and Improved Regulatory Processes
First let me explain specifically why Western Growers asked for
this hearing. On June 3, 2008--The Food and Drug Administration alerted
consumers in New Mexico and Texas that a salmonellosis outbreak
appeared to be linked to consumption of certain types of raw red
tomatoes and products containing raw red tomatoes and warned them not
to eat certain types of raw red tomatoes. The bacteria causing the
illnesses are Salmonella serotype Saintpaul, a relatively uncommon type
of Salmonella. Four days later on June 7, 2008 the Food and Drug
Administration expanded its warning to consumers nationwide that a
salmonellosis outbreak had been linked to consumption of certain raw
red plum, red Roma, and red round tomatoes, and products containing
these raw, red tomatoes and warned consumers not to eat these products
unless they could be effectively identified as being from one of
several states or countries that had been excluded as a potential
source for the suspect tomatoes.
This nuanced message was largely lost on consumers and to a certain
extent industry buyers who instead avoided purchasing all raw red, red
Roma and red plum tomatoes. As a result, growers on the okayed list
experienced severe restrictions in demand and depressed pricing.
One of our members, a Central California tomato grower, lost $1.4
million in revenue due to lower market prices related to poor demand.
Other members including Central Valley and Central Coast tomato growers
have reported losses ranging from $400,000 to $1.5 million. And
suffering perhaps the greatest damage among our membership, another
Central California member has sustained losses of nearly $3.4 million.
In addition to revenue losses in the market, several of our members
have had to disc up their tomato acreage because there are simply no
buyers.
To date, our members have experienced nearly $13 million in losses
at the farm gate related to the FDA advisory on tomatoes. It's
important to note that this $13M figure reflects only early season
losses. The growing season for tomatoes in California doesn't peak
until late July and August. As indicated earlier, the losses are
expected to increase. It is also important to note that these numbers
are calculated at the grower level, and do not include economic losses
sustained at other points along the supply chain, including shippers,
packers, processors, and retailers and food service.
In addition, two consumer polls were conducted recently surveying
attitudes about food safety and the potential to avoid commodities that
have been implicated in recent media stories. The first was a Produce
Marketing Association survey, conducted June 13 to 19, which found that
while 88 percent of those surveyed indicated they were regular
consumers of fresh tomatoes, \2/3\ of consumers had stopped purchasing
tomatoes. Remember, at this time only a few production areas in Florida
and Mexico had been implicated by FDA. But in the market, it didn't
matter that most of the country's tomatoes were deemed safe to eat. The
second survey, which has implications well beyond tomatoes, was an
Associated Press-Ipsos poll, conducted July 10 to 14, which found that
46 percent of people surveyed were worried they might get sick from
eating tainted products, such as tomatoes. In fact, these consumers
have changed their eating and buying habits over the past 6 months
because they are afraid they could get sick by eating contaminated
food.
Grower losses and waning consumer confidence underlie our principal
rationale for being here today. We have stated publicly that these
sweeping generalizations and speculations in the public arena cannot go
unquestioned and that the protocol for making a decision to implicate
an entire commodity generically must become transparent to the public
and subjected to fair and balanced scrutiny. When FDA takes action to
issue a broad consumer warning it is for all intents and purposes an
international recall for that commodity, regardless of production area,
or variety. A recall that calls into question the offerings of all
producers, handlers, retailers and food service providers causes
immediate and long-term damage to the marketplace.
Western Growers asks that the impacted growers be made whole, and
for changes to be made in the way FDA and CDC investigate outbreaks and
communicate outbreaks to consumers. The FDA and CDC have an entire
industry army at the ready to assist with any food borne illness
outbreak, but we are left largely out of the process. We have a common
goal: safety of the food supply.
To advance this common goal it is imperative that both industry and
government work together. True reforms, improvements and enhanced
protection of both public health and industry cannot occur in a siloed
fashion or by pointing fingers of blame. We must talk openly and
candidly about the declaration of outbreaks, the management of
traceback, and the communication with industry and the public including
examining CDC criteria for connecting a food source to an outbreak (as
well as the criteria for clearing it), FDA operating procedures,
internal policies, experience in tracing product in the fresh produce
industry, and the desperate need for improved messaging to industry and
consumers.
We are here today, a full 2 months after the outbreak began, with
no definitive idea as to what food item(s) is (are) responsible for the
illnesses. FDA has speculated in calls with the media that the outbreak
``could be'' attributed to tomatoes or ``foods commonly served with
tomatoes'' ``such as'' jalapeno and serrano peppers, cilantro, onions
or ``foods where these are common ingredients'' like salsa, pico de
gallo, guacamole. For every speculation there is a negative marketplace
reaction.
It borders on reckless for CDC and FDA to operate seemingly without
clear definitive criteria for when they can and cannot name or intimate
a commodity as a public health risk. We firmly believe that a
structured problem analysis must occur to quickly identify what is and
is not implicated by the epidemiology and that levels of confidence
must be established prior to impugning an entire commodity. While CDC
and FDA may conduct this analysis today, the analytical process has not
been effectively communicated to industry or others who could possibly
review and refine the approach. There must also be a specific timeframe
established to communicate at each stage of the analysis such that it
is clear at what stages information is released and or shared with all
parties. FDA has access to industry expertise that can help guide the
agency through the complexities of the produce supply chain quickly and
efficiently. It's imperative for FDA to establish an incident command
process--an outbreak team, if you will--that includes industry experts
and would be formally engaged from the very beginning to help the
agency in its investigations.
In protecting public health it is important to ensure FDA is able
to respond from a relevant position. World class manufacturing
organizations turn their inventories over 18 to 25 times a year.
Produce companies turn their inventories over 100s of times per year.
In the time it takes the system to identify an outbreak (up to 2 weeks)
growers may have turned their inventory over dozens of times. This lag
time coupled with the rapid movement of industry product puts FDA in an
``after the fact'' or ``reactionary'' position. We must look at the
entire system with an eye towards reducing this lag in order to improve
the overall ability of all parties to respond.
Industry Activity and Capability
Good Agricultural Practices (GAPs)
The fresh produce industry has a long history of activity in the
area of food safety. Much of the activity has centered on the
development and dissemination of guidelines to prevent contamination
from the field throughout the supply chain to the consumer. This work
has been and continues to be critical to the first element of FDA's
integrated strategy to protect the food supply (as outlined in the Food
Protection Plan of 2007) which is to ``prevent'' contamination in the
supply chain.
Western Growers has been integrally involved since our lead in the
development of the first ever ``good agricultural practices'' document
in the mid 1990's. This landmark industry work laid the foundation for
FDA and USDA to develop and publish in 1998 the ``Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and Vegetables'' which
today remains the benchmark utilized by FDA and USDA in gauging the
adequacy of prevention programs employed by the fresh produce industry.
That benchmark, while effective for most fresh produce commodities,
has evolved significantly for select commodities that have been deemed
a higher risk because of their continuing association with key
pathogens. In the last few years, beginning as a response to the
Produce Safety Action Plan issued by FDA in 2004, industry has
developed much more specific guidance for several commodities that
continue to be identified by FDA as higher risk including tomatoes,
leafy greens and cantaloupes.
These newer more specific sets of good agricultural practices have
again been widely disseminated and closely adhered to by producers of
these commodities. Adherence has typically been overseen by the
marketplace in the form of buyers who will not purchase from parties
that have not been rigorously audited to ensure they meet or exceed the
benchmark.
Driven by more recent outbreaks, both the tomato and leafy greens
industries have moved beyond the commodity specific guidelines to more
prescriptive sets of best practices. In close collaboration with the
FDA CFSAN and CDC scientists and with other public health and academic
partners, newer specific guidelines were developed driving the adoption
of more rigorous best practices by the industry to reduce or mitigate
potential risks.
With regard to leafy greens in particular, California and Arizona
have established uniform GAPs and a corresponding verification program
that requires implementation of food safety measures developed with the
FDA, CDC, state health authorities and private sector experts.
Compliance with the requirements is verified by government inspectors.
As a result of these newer generation guidelines, risk assessment
procedures, sampling and analysis of inputs, safety response measures
and requirements for documentation can now be verified in the field.
These guidelines have become the foundation for formalized verification
programs in which government inspectors audit production and handling
practices for compliance. They are a food safety lynchpin, for helping
FDA and industry advance efforts to prevent contamination.
Traceability
While efforts to improve our abilities to prevent contamination
have long been the focal point of industry activity, it is also clearly
evident that efforts to ``intervene'' and ``respond'' in the event of
food borne illness or positive identification of a contaminated product
are critical to protecting public health as well as important to
improving food safety systems. One element of key importance is
traceability. It is critical that producers, handlers and others within
the supply chain be able to quickly and efficiently identify where
product was sourced and to whom it was delivered so as to limit the
scope of any event.
In today's business environment, there are many requirements for
record keeping that facilitate tracing product from its point of
service to its origin. The legal requirements of the Perishable
Agricultural Commodities Act, the Bioterrorism Act and state
standardization and marketing laws all require documentation about the
entity to whom the product was sold, and from whom the product was
received.
These documents can be maintained in a variety of formats but when
handlers are asked to identify from where they sourced product and to
where they shipped product they can readily provide that information
today. Current industry approaches employed by shippers and processors,
associate a product with a number that conveys information on harvest
date, harvest crew, field location and grower, in other words,
traceback to the field.
In the recent investigation of tomatoes we have been repeatedly
told that industry's traceback capabilities have made it difficult for
investigators to follow the trail from a point of service to a
production field but we have received no information on where this
traceback breaks down. Is it a function of some entity not maintaining
required records? Are the records in a format that cannot be utilized
by FDA? Is FDA actually getting back to the handler level before
traceability is lost? Western Growers is firmly committed to leading
the industry to improving our own and FDA's ability to intervene and
respond but we must understand the challenges faced by FDA in this
arena.
During the current Salmonella outbreak, we have asked repeatedly
for this information, first when the investigation was focused on
tomatoes, and now, as the investigation has shifted to jalapenos.
Please don't misunderstand our frustration. We are not saying that
the industry could not improve its timeline for traceback. In fact, we
are participating in such an initiative underway that will be based on
a common language and uniform data requirements. But we have no
evidence that delayed traceback is to blame for the ongoing outbreak.
Conclusion
The industry adopts measures constantly to improve the safety of
our produce for the protection of our consumers. But what about our
protection? To exclude the industry from investigative procedures
ignores knowledge and expertise that only industry can bring to bear to
help bring outbreak to swifter conclusion. Instead, our industry is
left in ruin. We cannot sit by any longer. We must be made whole, and a
new, more transparent, more participatory communications and
investigative process must emerge from the FDA and CDC.
The Chairman. Thank you very much, sir.
Next up, we have Bryan Silbermann, President of the Produce
Marketing Association, and I am going to admonish all our
witnesses, I know you have come a long way to testify. I have
read every one of our prepared testimony. We are getting very
long in the day here. We have other folks and we have other
meetings that I am missing to be here today. This is very
important to our country, so I have no problem with that, but
whatever you can do to summarize your testimony and get the
most salient points, I would appreciate it. Mr. Silbermann.
STATEMENT OF BRYAN SILBERMANN, C.A.E., PRESIDENT, PRODUCE
MARKETING ASSOCIATION, NEWARK, DE
Mr. Silbermann. Chairman Cardoza, Members of the
Subcommittee, my name is Bryan Silbermann, President of the
Produce Marketing Association and I will briefly summarize my
written comments.
PMA is the largest worldwide association of companies that
market fresh fruits and vegetables. We represent 3,000
companies and their subsidiaries spanning the entire produce
supply chain. Since our start nearly 60 years ago, PMA has
pioneered packaging concepts for produce and served as a
clearinghouse for standardization. Over the past 2 decades,
this Association and I personally have been at the center of
developing standards to improve the flow of information from
produce packinghouses to the consuming public. Mr. Chairman,
that includes those small stickers on the fruit and other items
shipped from your district as well as standard barcodes on
packaged produce. This involvement combined with our members'
commitment to provide fresh and wholesome fruit and vegetables
compel us to appear here today.
It has been said many times that food safety is the top
priority for all our members and it has been that way for many
years. The deeply troubling spinach E. coli outbreak and the
recent Salmonella outbreak are tragedies that shake the
public's trust. Rather than casting blame, we want to and need
to work on solutions. We all have a shared responsibility to
protect public health.
The produce industry has already changed rapidly to avoid
the introduction of risk into the food system. This paradigm
shift brings with it new responsibilities, not just for us but
also for government. We cannot as an industry reflexively
oppose regulation but government action must recognize and
harness the ingenuity of the private sector to improve food
safety and to gain back the full confidence of our consumers.
At the same time, it is not our role as the private sector to
wait passively for government to regulate. We must act and we
are already doing so.
Today's hearing is recognition that traceability is one key
to the food safety process, and I would like to applaud Dr.
Osterholm's comments about how it is a second step in the
process that must follow associations done by public health
authorities. Unlike other food industries, the produce
marketing chain has been required to maintain records since the
1930 passage of the Perishable Agricultural Commodities Act.
The Bioterrorism Act added the ``one up, one back'' concept,
but the requirement for comprehensive record-keeping has been a
longstanding legal obligation. Focusing exclusively on this
legal requirement misses the advancements we have made to
improve not just the retention of records but also the tracking
of fresh produce.
Our companies have internal systems to track produce.
However, the very handling needs of hundreds of different fresh
fruits and vegetables and the diversity of systems needed to
manage them made us look to common elements to enhance and
speed up the link between these diverse approaches.
Last year PMA, United Fresh and CPMA launched a
traceability initiative to reach across the entire supply
chain. This proposes that these three common elements use an
existing, standard, global format. I want to stress the words
``global'' and ``standard'' because the solution we develop
must work for all fresh produce, no matter where it is grown or
shipped. The three comments simply are, number one, a global
trade item number which identifies the supplier as well as the
item in the case, number two, the lot number, and number three,
the harvest or pack date. These three pieces of information
will be on each case in human readable form. By reading the
label, one will know the supplier of the product and the lot
number assigned. The information is also encoded in a barcode
each company can scan, giving every handler a record of when
the case entered and left his facility. Think of these three
pieces of information as a baton that is passed by one runner
in a relay race to the next. That common information then
travels and can be tracked from start line to finish. I also
want to stress, Mr. Chairman, that we have reached out as an
industry to brief both FDA and USDA officials on this work.
In less than a month, the initiative steering committee
will be meeting to approve an action plan and a timeline for
implementation. First, you will see produce suppliers begin
labeling cases with both human-readable and machine-readable
information. Next, companies will begin reading and storing
this electronically. Through this process, we will have faster
enhanced traceability across our supply chain.
As an industry, we take seriously our obligation to develop
solutions, not just the traceability initiative I have
described. We also must help determine what went wrong in the
Salmonella investigation. That is why during this crisis, Mr.
Stenzel and I jointly wrote to Secretary Leavitt to offer our
assistance in uncovering the source of the pathogen by lending
industry's unique knowledge of distribution and handling
processes. We wrote again when our first letter went unanswered
and only recently did we hear that we will eventually meet with
FDA and CDC on this. We want to participate in jointly and
transparently learning lessons and improving regulators'
process of traceback.
Just as we recognize our obligations, it is our profound
hope that any future legislative and regulatory changes will be
fashioned to work with the industry to fulfill our shared
responsibility, which is to protect public health by providing
safe, wholesome and nutritious food, every bite, every time.
Mr. Chairman, thank you for the opportunity to appear
before you today. I look forward to answering your questions.
[The prepared statement of Mr. Silbermann follows:]
Prepared Statement of Bryan Silbermann, C.A.E., President, Produce
Marketing Association, Newark, DE
Chairman Cardoza, Ranking Member Neugebauer and Members of the
Subcommittee, I am Bryan Silbermann, President of the Produce Marketing
Association (PMA). I am honored to appear before you to address the
topic of this hearing: the legal and technical capability for full
traceability in fresh produce.
PMA
PMA is the largest worldwide trade association of companies that
market fresh fruits and vegetables. We represent 3,000 companies and
their affiliates across the produce supply chain, ranging from grower-
shippers and supermarket retailers to hotel and restaurant chains, as
well as other buyers of produce worldwide. Within the United States,
PMA members handle more than 90 percent of fresh produce sold to
consumers. Reflecting the global nature of our industry, we also have
members in over 50 countries.
PMA serves the industry on the issues that are important to it.
Since our start nearly 60 years ago, PMA has pioneered packaging
concepts for produce and served as the clearinghouse for
standardization of these issues. Over the past 2 decades, the
association--and me personally--have been at the center of developing
standard systems to improve the flow of information from produce
packinghouse to the consuming public. This work includes the advent of
those small identification stickers that are so ubiquitous on tree
fruit and other produce shipped from your district, Mr. Chairman, as
well as standard bar coding on produce packages sold in supermarkets.
This involvement, combined with our members' commitment to provide
fresh and wholesome fruits and vegetables, compel us to appear before
you today on this important topic.
The Way Forward
One illness linked to the products our members grow and market is
one too many. Food safety is the top priority for our members, now as
it has been for many years. The deeply troubling spinach E. coli
outbreak in 2006 and the recent Salmonella outbreak are tragedies that
shake the public's trust, and cause us to review all actions by
industry and by those who regulate us. Rather than casting blame we
need to work toward solutions. Speaking today before Congress, with my
industry colleagues, Federal regulators and experts, I want to talk
about our shared responsibility to protect public health.
Clinging to old ways is not an option. Because consumers rightfully
expect safe food, our buyers--retail and foodservice--demand exacting
food safety standards, and assurances they are being met; in turn,
suppliers are evaluated in light of this new reality of the marketplace
and on their ability to ensure the safety of their product. Turning the
page on the past, the produce industry has already rapidly changed to
avoid the introduction of risk into the food system. This paradigm
shift brings with it new responsibilities for industry, and for the
government. Industry cannot reflexively oppose regulation--but
governmental action must recognize and harness the ingenuity of the
private sector to improve food safety and to gain back the full
confidence of our consumers. At the same time, it is not the private
sector's role to wait passively for government to regulate; we must
act.
Reflecting the will of our members, PMA has already taken
considerable action on food safety. We have contributed $2 million to
the creation of the Center for Produce Safety at the University of
California at Davis. My organization also provides funding for and
volunteer leadership of the public-private Partnership for Food Safety
Education, which educates consumers on safe handling practices in the
home. We have endorsed the idea of mandatory good agricultural
practices based on risk specific to certain commodities and have
recently advised FDA that we support the concept of certification of
food safety by third parties. Further, PMA with our colleagues have
launched an industry-wide effort on traceability.
Traceability
Today's hearing is recognition of the importance of traceability to
the food safety process; that is, the ability to determine the origin
of suspect product and its path from the farm to the consumer. Over the
next several months, we need to learn lessons from the Salmonella
investigation to understand what went wrong and why the investigation
took the path it did. It is very early in that process, and we have
numerous questions that should be answered in a searching review that
must include all stakeholders. It is our common duty to protect the
public. If that process identifies gaps in the current system, the Food
and Drug Administration should close those gaps--but such actions
should not be based on rumors or speculation; they should be based on
science.
Unlike other food industries, the produce marketing chain has been
required to maintain records since the 1930 passage of the Perishable
Agricultural Commodities Act. The Bioterrorism Act added the ``one up,
one back'' concept, but the requirement for comprehensive record-
keeping is a longstanding legal obligation in our industry.
Critics have said the Salmonella event demonstrates the limitations
of the industry's current traceability system, and that current
regulations do not go far enough. Focusing exclusively on the legal
requirements misses the advancements the private sector has made to
improve not just the retention of records, but also the tracing of
fresh fruits and vegetables. Many companies have already implemented
internal systems to track produce, but this multiplicity of systems
caused industry leaders to see the need to create a common platform to
link the disparate approaches. PMA joined with the Canadian Produce
Marketing Association to develop an Implementation Guide to Fresh
Produce Traceability that was first published in 2004.
Last year, PMA, CPMA and United Fresh Produce Association began a
traceability initiative to reach across the entire supply chain. At
that time, I said:
``Our food safety system is not complete without a more robust
and quicker ability to rapidly recall our products and trace
their history. The issue of how to have improved traceability
is not about technology; it's about changing our business
practices. Effective traceability must be a business imperative
for everyone in our industry. Consumers and regulators demand
it.''
These words are even more true today. The initiative has moved
quickly to create a standard methodology for maintaining key
information. Comprised of more than major 50 produce buyers, sellers,
brokers, terminal markets, distributors and wholesalers, the Produce
Traceability Initiative's Steering Committee acknowledges that each
member of the supply chain will have its own traceability system.
However, these systems must be adapted so that important information
can flow through the supply chain in a common format that uses existing
global information standards. I want to stress the word global, because
the solution we have developed must work for all fresh produce, no
matter where grown or shipped. I also want to stress that from the
initiative's beginning, we have briefed FDA and U.S. Department of
Agriculture officials and others on our work.
As developed by the initiative, the process uses three pieces of
information: (1) a Global Trade Item Number (GTIN), which will identify
the ``manufacturer'' of the product and the produce that is in that
specific case; (2) the lot number; and (3) the harvest or pack date.
These three pieces of information will be on each case so that the
numbers are intelligible to the human eye. Immediately, by reading that
case's label, you will know the origin of the product and the lot
number assigned to it.
What is more, the information will also appear in machine-readable
form on that label, in a barcode each member of the supply chain will
be required to scan so that the information will be maintained in its
computer system. Having the specific lot number and pack or harvest
date, each handler will have a record of when that particular case
entered and left its facility. Think of these three pieces of
information as a baton that is passed by one runner in a relay race to
the next; that common information then travels--and can be tracked--
from the start to the finish lines.
The Produce Traceability Initiative's process avoids a bloated and
unworkable central computer system to warehouse all of the data for an
entire industry that ships in this country alone more than five billion
cases of produce annually. Because the three pieces of information will
be standard, and because each link in the supply chain will scan that
information into its computer systems, each link will be able to
determine with a quick computer search the origin of the produce and
its destination. These searches can be done simultaneously rather than
sequentially--so we can get answers faster.
The process works the same when a commodity is ``repacked.'' When
repackers commingle produce from multiple growers into one case or
simply repack the case, they become the new ``manufacturer.'' As such,
they will be responsible for assigning a new GTIN (now showing them as
the new ``manufacturer'') to that new case, as well as the
corresponding lot number and pack date. They must also establish a link
between the new GTIN and the original GTINs and associated lot numbers
and pack or harvest dates.
In less than 1 month from today, the steering committee for the
initiative will meet to approve and release to industry an action plan
along with a timeline for implementation throughout the industry.
First, produce suppliers will be directed to have the capacity to label
cases with both human-readable and machine-readable information; next,
everyone in the supply chain will be expected to read and store that
information--and chainwide traceability will have been achieved.
The Produce Traceability Initiative relies on several elements that
will be the keys to its success. It relies on core pieces of
information that are consistent across the supply chain, and are
maintained on the case itself. Each participant in the supply chain
retains that consistent information electronically. The initiative
builds on the individual traceback systems that currently populate the
marketing chain, by knitting a common thread among them.
Conclusion
Whole-chain traceability, we believe, is our responsibility to the
public and the produce industry takes seriously its obligations to
develop traceability solutions. These solutions include not just the
Produce Traceability Initiative I have described today; it also
includes helping to determine what when wrong when the tomato industry
was apparently wrongly fingered as the culprit in the Salmonella
outbreak. During this crisis, PMA and United Fresh jointly wrote to
Secretary Leavitt, of the Department of Health and Human Services, to
offer our assistance in uncovering the source of the pathogen by
lending the industry's unique knowledge of distribution and handling
processes. This information could and should serve as the key to unlock
the Salmonella mystery. We wrote again when our first letter went
unanswered, and only recently did we get an assurance that we would
eventually get to meet with FDA on these matters. In the coming months,
we also want to participate in learning lessons and in improving
regulators' traceback in light of ongoing industry efforts.
Just as we recognize our obligations, it is our profound hope that
any future legislative and regulatory changes will be fashioned to work
with the industry to fulfill our shared responsibility to protect
public health by providing safe, wholesome and nutritious food, every
bite, every time.
I thank you for the opportunity to appear before you today, and I
look forward to answering any questions you may have. Thank you.
The Chairman. Thank you, sir.
Mr. Stenzel, welcome to the Committee again and thank you
for being here and sharing your information with us.
STATEMENT OF THOMAS E. STENZEL, PRESIDENT AND CEO, UNITED FRESH
PRODUCE ASSOCIATION, WASHINGTON, D.C.
Mr. Stenzel. Thank you very much, Mr. Chairman and Members
of the Committee. It is a pleasure to be here. We appreciate
you holding this hearing. United Fresh Produce Association
represents the total supply chain in the fresh produce
industry, concentrated here doing business in the North
American market but also globally as well.
I am going to summarize my comments at this late hour. I
submitted an extensive written testimony for the Committee. Let
me start with prevention. That is where it all starts. We in
the produce industry hold ourselves to rigorous standards in
growing and handling fresh foods and we support strong Federal
oversight of commodity-specific risk-based rules. We have
worked closely with Mr. Costa and Mr. Putnam in the development
of their legislation and urge the Committee to lend its support
to those efforts.
We are also committed to compliance with the traceability
rules of the Bioterrorism Act in ensuring our industry's
ability to track fresh produce from the retail store or
restaurant all the way back to the farm. I want to say that
this is true also for all produce sold in the United States,
not just grown in the United States. We in the produce industry
have an obligation that whenever consumers go to their grocery
store or restaurant, it doesn't matter where it is grown, it is
not ``safe in one place and not safe in another.'' It is our
responsibility to assure no matter where produce is being
consumed by American citizens, it is safe.
Now, in this particular outbreak, I want to make one thing
very, very clear. Traceability worked. I thank Dr. Osterholm
for making this point so it is not just an industry point of
view. FDA was in fact able to trace tomatoes back that had been
eaten by sick consumers all the way to the farm. The only
problem was that those tracebacks kept pointing to different
farms. But those aren't false leads. Those aren't tracebacks
that didn't work. Those are tracebacks that pointed to the fact
that there was not a common point of contamination for all
those tomatoes. Very, very early in this investigation, we
should have known that tomatoes were not the sole cause of all
of those illnesses across 43 states. Perhaps there is yet
judgment to be made as to any plausible explanation of tomatoes
having been involved at all. We don't think so but we will hold
our judgment as well. But early on everyone should have known
that tomatoes were not the sole cause of this outbreak.
We hear complaints about traceability and how difficult it
is, but the stories about FDA having to pour through boxes and
boxes of records just don't ring true to those of in the
industry, to Mr. DiMare, who can track his tomatoes up and down
the supply chain, and even to investigators such as those in
Minnesota, who were able to describe tracking product back very
quickly. Even in the Minnesota case, I might add, from a very
small restaurant, not a national chain; but the ability to find
out where that product came from, go all the way back and, as
Dr. Osterholm said, finger the exact tiny distribution center
on the border of McAllen, Texas, and eventually get back to the
farm. The fact that we now have positive identical samples on
jalapeno peppers from these facilities is just remarkable. In
fact, this would be my exhibit for traceability working, that
Dr. Acheson showed you, this chart. Look at that ability. Once
they started looking for jalapenos, they got there very, very
quickly.
The produce industry understands better than anyone that we
have the most to gain from isolating produce that may be part
of a problem, and that goes to the initial identification of
what is the food vehicle involved. In this particular case, it
is clear that CDC did not have the right story from the
beginning. Whether they were 100 percent wrong, we do not know
yet. But clearly when they issued a broad warning that tomatoes
were that cause of this outbreak, there was no mention of
jalapenos. They had missed something in the early outbreak
identification. That is something that we just have to look at,
not so much the traceability back but look at that initial
identification of product.
This past Friday, FDA concluded that jalapenos grown in the
United States were not associated with this outbreak, and that
is indeed very good news. We have growers now who are once
again shipping truckloads of jalapenos from North Carolina and
Georgia, and that is important. But you know what? It is also
important that there are a lot of Mexican producers of
jalapenos who also are not involved in this outbreak either. We
have to narrow the suspicion down to the ultimate source. We
can never let geographical boundaries, whether national or
state or county borders, be shorthand for food safety, and I
remind the Committee that in the spinach outbreak, we went
through this exact same problem when three counties in
California were all labeled under suspicion equally when we
know that there was only one place where there was contaminated
product. So geography is not shorthand for food safety.
Mr. Chairman, let me conclude my remarks with a brief
comment about compensation. We would like to thank Congressman
Mahoney for your efforts to step up with the bill to provide
disaster assistance. What a true disaster this has been, as
much as any hurricane or flood in our industry, but it is a
disaster that struck our entire industry. It struck the entire
tomato supply chain, whether our growers who were plowing under
fields or others in wholesale and upstream had to take product
out to the dump. As you consider potential support for the
tomato industry, I ask you to think about both the growers we
represent but also their customers who had already paid for
that produce and also took losses in having to throw it away
unnecessarily.
Thank you.
[The prepared statement of Mr. Stenzel follows:]
Prepared Statement of Thomas E. Stenzel, President and CEO, United
Fresh Produce Association, Washington, D.C.
Good afternoon Chairman Cardoza, Ranking Member Neugebauer, and
Members of the Committee. My name is Tom Stenzel and I am President and
CEO of the United Fresh Produce Association. Our organization
represents more than 1,500 growers, packers, shippers, fresh-cut
processors, distributors and marketers of fresh fruits and vegetables
accounting for the vast majority of produce sold in the United States.
We bring together companies across the produce supply chain from farm
to retail, including all produce commodities, both raw agricultural
products and fresh ready-to-eat fruits and vegetables, and from all
regions of production.
Thank you for holding this hearing to begin a detailed examination
of what has been one of the most frustrating and damaging
investigations ever of a foodborne disease outbreak. This investigation
has been damaging to consumer confidence in our food safety system,
damaging to consumer health in scaring the public away from healthy
produce while failing to properly identify the source of contamination,
and damaging, of course, to the entire tomato industry.
Let me state again for the record something you've heard many times
before, and will hear many times in the future. Food safety is our
industry's top priority. The men and women who grow, pack, prepare and
deliver fresh produce are committed to providing consumers with safe
and wholesome foods. And let me add, they are also committed to
compliance with the traceability requirements of the Bioterrorism Act
and ensuring our ability to track fresh produce from the retail store
or restaurant back to the farm.
As today's hearing is focused on traceability, let me begin with
this--I believe that traceability worked in this outbreak. Despite some
hurdles which I will address later, FDA in fact was able to trace
tomatoes eaten by sick consumers back to the farm. The only problem was
those tracebacks kept pointing to different farms. Rather than
complaining about the complexity of the tomato industry and so-called
false leads sending the search to myriad farms across two countries,
the evidence was staring government in the face. There was no common
point where all of these tomatoes could have been contaminated, whether
at the farm or in repacking at the wholesale level. Traceback worked;
it just didn't confirm the hypothesis that the Centers for Disease
Control had advanced, and that we now know was most likely wrong.
For weeks and weeks, investigators were on the trail of the wrong
product. That speaks to a fundamental need to reassess how CDC conducts
its initial assessment of potential foods that might be linked to an
outbreak, the degree of certainty they affix to inexact science, how
decisions are made on when to warn the public and what to say, and when
to admit a mistake and find the real culprit rather than fear for
embarrassment in changing course. These are questions for another day,
but we urge this and other Committees to seriously tackle each of those
issues.
Let me turn specifically to a discussion of traceability in our
industry. As context, let me suggest that an individually packaged food
item with a UPC code and lot number provides about the most complete
traceability possible. You simply punch in that code and the company
can tell you when the item was packed, in what facility, and usually
even whether it was packed on the morning or afternoon shift.
Ironically, that's the specific case with the E. coli outbreak
associated with spinach 2 years ago. The only contaminated spinach ever
in the marketplace was bagged on one shift, on one day, in one
processing plant, with the same lot code appearing on every bag.
Yet, who can forget the 4 week nightmare for consumers and industry
with FDA first saying to avoid all spinach, then supposedly narrowing
the focus to ``counties of concern'' where spinach may have been grown?
Never mind that 95% of the spinach in the marketplace was grown in
these counties. Here we had the most immediately traceable food product
individually labeled with a lot code, and it took weeks before FDA
finally began to tell consumers they could eat spinach again. Contrast
that with the peanut butter Salmonella outbreak. After months of
investigation, a recall of certain lot codes from one manufacturer was
launched, and consumers merely switched to a different brand the next
day. No intense search for where the peanuts were grown, and whether
potentially contaminated peanuts were elsewhere in the distribution
system or other products.
My point is this--even with perfect traceability with an
individually packaged produce item with a lot code on the bag, there is
still a flaw in the way in which CDC and FDA are going about produce
investigations. They just do not seem to understand what can admittedly
be a complicated sourcing and distribution system required to assure
the quality of fresh perishable foods to consumers. But broad brush
warnings not to consume an entire commodity group make no sense when a
better understanding of produce distribution systems and the
traceability systems in place today can effectively narrow the point of
concern. FDA should work much more closely with industry, and with
USDA, to better understand produce distribution systems. Today, each
investigation seems a totally new learning experience rather than the
execution of a well-prepared and well-drilled crisis plan.
I mentioned in the beginning that produce industry members are
committed to full compliance with the Bioterrorism Act and its ``one-
step-up; one-step back'' requirements. Industry members take that
responsibility seriously. While produce often changes hands between
farm and table, industry members are able to track a majority of
produce from retail back to farm source. Stories in the press about
having to pore through reams of paper records and mysterious spider
webs in the supply chain just don't ring true to industry members who
track produce pretty efficiently everyday. And, that's not just
industry talking. One of the more interesting developments in this
outbreak investigation was the report from Minnesota health officials
that they quickly identified jalapenos as the real culprit, not
tomatoes, and then quickly traced the peppers back from a small
restaurant in Minneapolis, to the distributor, wholesaler and farm. The
Minnesota investigator is quoted in the media saying it takes ``a few
phone calls and you can work it fairly quickly back to the grower.''
So why is this proving so difficult for FDA? In my conversations
with both FDA and with member companies who have had FDA field
investigators in their facilities, it appears that the demand for paper
records may be FDA's doing. Even when a wholesaler can tell FDA where a
product came from, it seems that FDA is dependent upon a legal trail of
paperwork, seeking to make sure that all the details such as number of
boxes, brand names, lot codes, ship/receive dates, etc. correlate
exactly on invoices, bills of lading, etc. I'm told of field staff
faxing hundreds of pages of records to FDA headquarters for someone to
try to read through and connect the dots. No wonder they complain about
that process. This overly legalistic approach may be appropriate to
build a court case 2 years from now, but it is not conducive to rapid
protection of public health. Perhaps that's one explanation why most
industry members throughout the distribution chain can report who
they've received produce from, and keep tracking back to the farm.
Before there is a knee-jerk reaction to pass new laws or
requirements for traceability, we urge the Congress to fully examine
how FDA today conducts tracebacks, and whether those systems are
appropriately designed to protect public health and get back to the
farm as quickly as possible. We have asked FDA to show us specifics
where they've run into problems, so industry can help. We also urge the
Committee to ask the agency for specific examples and answers to these
questions, rather than a theoretical discussion or generic statement of
frustration. This is too important to gloss over the details.
Nevertheless, the produce industry understands better than anyone
that we need the most efficient and quickest traceability systems
possible. We have the most to gain from isolating produce that may be
part of a problem as quickly as possible. The fewer people who get
sick, and the quicker a problem is contained, the better off we are. I
read one recent news report where someone suggested the industry might
not want to trace a problem back to a farm and thus avoid
responsibility. Are you kidding? Does anyone remember the angry mob
with torches chasing the Frankenstein monster? This industry would
storm the barricades to quickly identify the real source of
contaminated food, no matter where that finger points.
And that brings me to the other incentive we have to continuously
enhance traceability--we have the most to gain by ruling out concerns
about produce that is clearly not related to a problem. This past
Friday, FDA concluded that jalapenos grown in the United States were
not associated with this outbreak, and narrowed their consumer advice
accordingly. That was a critically important step, especially for one
of our Georgia growers who went from shipping six truckloads of
jalapenos a day to nothing. Incidentally, he's testifying before the
Agriculture Appropriations Committee today. But we also urge FDA to
narrow their investigation within Mexico as quickly as possible.
Clearly, many Mexican producers are not associated with the outbreak
either. We should never accept geographical boundaries, whether
national, state or county borders, as shorthand for food safety. Our
goal in every case of a foodborne disease outbreak must be to find the
specific source as quickly as possible, and free the rest of the
industry from suspicion.
That's why United Fresh Produce Association joined with the Produce
Marketing Association and Canadian Produce Marketing Association last
year to launch an initiative to build a common framework and
nomenclature for case labeling, better transparency, and streamlined
connectivity across the supply chain. That initiative is guided by a
Steering Committee of more than 50 produce retailers, wholesalers,
distributors, packer-shippers and growers. The committee has met four
times this year--before this outbreak--and is now finalizing action
plans and timelines for industry adoption.
The Produce Traceability Initiative will help connect the internal
traceability systems of each member of the supply chain. This whole-
chain connectivity is based on three pieces of information that will be
labeled on every case of produce: (1) a Global Trade Item Number
(GTIN), which will identify who the originator of the case is and the
type of product that is inside; (2) a lot number specifically
identifying the produce; and (3) the pack or harvest date. This
information will be labeled on each case so that the numbers may be
read and understood universally throughout the supply chain. Labels
will also carry a barcode, which each member of the supply chain will
be able to scan so that the information can be stored.
This system also works when produce must be re-packed or commingled
to ensure the best quality to consumers. When repackers commingle
produce from more than one grower into one case, they become the new
``manufacturer''. As such, they will assign a new coding number to the
new case, but will also maintain a link between the new case number and
the original incoming cases. In fact, systems to keep track of
different incoming product sources are used widely in the tomato
repacking business today.
One the key reasons industry is pursuing this approach is to
harmonize standards for efficiency. With one common set of standards
for case labeling, product tracking can be performed simultaneously in
different stages of the supply chain, rather than sequentially.
This is an exciting and important development for industry
efficiency, and the best example I know of an industry committed to
constant improvement in traceability. But I want to repeat for the
Committee that traceability was not the problem with this outbreak
investigation. And, this or any other traceability system is not the
solution to the problems identified over the past 2 months.
Produce traceability worked in this outbreak. It provided
tremendous evidence that tomatoes were not the cause of the outbreak,
as there was no single point where contamination may have occurred.
And, once investigators began looking for the right commodity,
tracebacks from Minnesota and from the FDA led to the warehouse of a
small produce distributor where an identical sample of the outbreak
strain was found. And, FDA even knows which farms supplied this small
distributor.
If I may Mr. Chairman, let me conclude with a brief comment about
compensation. We all know the error in CDC's initial assessment that
fresh tomatoes were the sole cause of this outbreak. While CDC has not
yet stepped away from its suspicion that tomatoes might have caused
some of the earlier illnesses, this is neither a likely nor plausible
position without some real evidence. The fact that consumers didn't
know that they had eaten jalapenos chopped up in salsas, garnishes, or
other foods is no reason for CDC to cling to the accuracy of their
initial food surveys just out of pride. Even good scientists can make a
mistake, and there's no shame in admitting that consumers apparently
were just unaware of this hidden ingredient in their foods.
There can be no doubt that this has been a disaster for the tomato
industry, and we support Congressman Mahoney's H.R. 6581 as a step
toward providing disaster assistance to our agricultural sector just as
vital as any hurricane or flood. It's also a fact that this disaster
struck every company in the tomato supply chain whether they had to
discard full warehouses of perfectly healthy tomatoes, haul product to
the dump, watch fruit rot on the vine, or plow fields under. I know
well that this is the Agriculture Committee, but I ask you to think
about both the growers we represent, and also our growers' customers
who had already paid for their produce, but were forced to discard
millions of dollars of product.
Our supply chain for fresh perishable foods is truly an
interdependent agricultural industry, and now is the time for all of us
to stand together for what's right.
Thank you for your time and attention.
The Chairman. Thank you, Mr. Stenzel.
I would share with you that your last point is well taken.
Mr. Etheridge and I have had significant discussions already
about how we deal with whether or not crop insurance could be
made the risk holder for this. Certainly compensation is a
concern if you look to FDA or someone who is actually making
the adjudication for compensation. While in my opinion they
have made some errors or potentially have made some errors, how
would compensation affect their future judgments to make the
same kind of calls? Frankly, we need them to be able to make
calls that are not based upon whether they have to take money
out of their agency for compensation.
So Mr. Etheridge, Mr. Peterson, other Members, and I have
been talking about how we go about looking at the compensation
that should somehow come back to this industry that has been
implicated but not necessarily indicted. I know the growers in
my area have been devastated and it is nothing they have done
of their own doing. So I can't imagine any other businessman
who would subject themselves to the vagaries of the weather, to
pestilence, to all the rest and then also submit themselves to
the regulatory agencies; farmers are certainly a hearty breed
and they keep doing it. I often ask myself why they do. I know
the answer, because they love what they do, but they ultimately
have to make a profit at the end of the day, and we have seen
an industry just be devastated here, and I thank you and Mr.
Giclas and Mr. DiMare, all of you for your testimony.
I have a number of questions. I want to start out with Dr.
Osterholm. What did Minnesota do differently from other states
in their investigation that led to the implication of peppers
directly?
Dr. Osterholm. Mr. Chairman, first of all, they had the bad
or good luck, I guess, depending on how you look at it, of
actually having cases occur that were all associated with one
of two restaurants, local restaurants in the Twin Cities that
made it easier to investigate. But the most important reason is
that Minnesota has dedicated foodborne disease surveillance and
outbreak investigation as a very high priority, and as such,
they actually have a team of graduate students known
affectionately as Team Diarrhea, that literally on a real-time
basis are interviewing case reports that are coming in on a
daily basis. Our turnaround time for the pulsed-field gel
electrophoresis and the analysis is less than 3 days every time
so that in fact this group has solved many outbreaks. Last year
we had an outbreak of a rare kind of Salmonella that had been
occurring in the United States for the better part of 6 months.
When the first three cases occurred in Minnesota, within
literally 1 week, Minnesota fingered the potpies and broke open
the entire national investigation that had gone nowhere for 6
months.
So I think what it is, is a system. In my written testimony
to you, I actually lay out what we do, how we do it. It is not
rocket science. It is commitment. It is willingness to do it.
It is not accepting a state like Texas that takes 5 weeks to
get their pulsed-field gel electrophoresis results done. It is
the fact that we don't wait for a county health official to
decide they are not going to go ahead and interview a patient.
It is all done centrally. We believe that this entire system
could be replicated across all 50 states for somewhere between
$50 million and $100 million annually. When you think about the
cost of one of these outbreaks getting missed, that seems like
a small amount of money to put forward. I tell you this at the
time when the Federal resources for this are being cut so that
just as we are talking about this right now, the very support
that has happened over the 4 years for all the states is being
cut. So I think that is the big distinction. Minnesota made it
a priority. They have done it. They showed it can be done and
we just have to hold all the other 49 states to the same
standard.
The Chairman. I totally agree with you.
To all our panelists, prior to and during the recent
warnings concerning tomatoes, what input were you asked for by
the CDC and the FDA and what input did you give these agencies,
either solicited or unsolicited? Mr. Stenzel, we will just go
down the line and start with you. Since you spoke last, we will
give you the first shot and go the other direction.
Mr. Stenzel. Prior to the issuance of the warnings, no
input whatsoever. We were not asked or consulted. In fact,
there was a very quick notification by FDA to the industry that
New Mexico believed that tomatoes had been associated with this
outbreak and quickly CDC was going to be issuing a public
statement. So no input there. During the course of the
investigation, I appreciate and would thank Dr. Acheson for his
efforts to keep the industry informed. They did reach out and
share information with us, but one of the most frustrating
things about this process is, there was a lot of information
they either couldn't share or wouldn't share and they were very
slow to take any kind of input back from the industry, and I
have to be specific. Specifically, one of my concerns is with
CDC. We repeatedly were asking for data on how the illnesses
had occurred, in what order, what geographic locations.
For us in the industry, we can look at the spread of an
illness, and if it is moving from Texas to New Mexico and then
up to Illinois, we can look at our own distribution patterns
for tomatoes. Quickly, once we got past about ten or 15 states,
we knew this was not all related to tomatoes. There is no
single point, there is no one farm, there are no repackers who
would process all of those tomatoes to all of those geographies
yet they didn't really listen to that point of view.
Mr. Silbermann. Mr. Chairman, I would agree with everything
Mr. Stenzel has said. I would thank Dr. Acheson for his
outreach once the announcements were made and the way in which
FDA briefed us, but I would draw a parallel. Imagine that you
are an orthopedic surgeon and you are being asked to do surgery
with an arthroscopic device and you can't see down that
arthroscopic device to see what is inside the body. That is the
way we felt, quite honestly at PMA, giving a lot of
information, not seeing the endpoint, not seeing the picture
but being asked to comment on it. That is the way we felt in
this process.
Mr. DiMare. We at the DiMare Company were contacted by FDA
at a couple different levels. One of our repack locations in
Houston was contacted through one of the tracebacks with
tomatoes. One of the problems I had with FDA was I felt first
of all that some of the people from FDA that did the
investigation had no experience on the food side. We had a
person that was from the drug side that was in the operation.
Also, we had, I think it was about a week-long process of a
full audit of our facility without again any relation or
tracing back of any positive evidence that any of the tomatoes
that we were distributing contained the Salmonella Saintpaul
outbreak. From a grower packing level, we were contacted by FDA
in both our Ruskin and Homestead operations, again from a
traceback that led back to some of the customers that we
supplied--had supplied in this one case a retailer actually in
Georgia led the traceback back to our two packing facilities
and it happened to be specifically on plum and Roma tomatoes,
not round tomatoes.
The investigator in our Homestead operation who I had
spoken to on the phone personally several times, it was a very
frustrating process. It was frustrating in the sense that he
really didn't know what he was asking for, a lower-level FDA
person that was being given directives from the higher ups
above within FDA. In fact, the questioning started out when he
first contacted me as he wanted to see information and all
information on all tomatoes in all our operations. I said are
you sure you want to see information on all types of tomatoes
in all the operations, that is a lot of information you are
asking for, I prefer that you name something specifically. Is
it Romas, is it rounds, which location are you looking for. I
was then contacted by an official from FDA out of the Tampa
office that did the follow-up in our Ruskin location. She was
very specific in what she wanted and I asked her, do you want
to see information on all round and Roma tomatoes or just one
type specifically. She stated very clearly we are looking at
specifically Roma tomatoes and we are looking at it for this
particular window. It was about a week or 10 day period of
shipment that they were looking for. That is a heck of a lot
different from the information I got from the other
investigator----
The Chairman. Mr. DiMare, let me stop you because we are
going over, but this is really important to the Committee. You
have indicated in your testimony that you do over-sampling much
greater than maybe--you do a lot of sampling for pathogens in
your company.
Mr. DiMare. Yes, sir.
The Chairman. Did you share that information with FDA or
CDC?
Mr. DiMare. Yes. In fact, in the Houston case, some of the
product that they were looking at was product actually of our
own. In other words, it actually came from our own farm packing
operations, which is not unusual. In this particular case, it
was product that we actually grew and packed, and in those
instances, we had done pathogen testing specifically for
Salmonella.
The Chairman. Thank you. I am going to have to move you
along, and there is a rationale why I am asking this question.
When you passed on that information, did it have any impact on
their investigation?
Mr. DiMare. I am not sure it did. The only comment I got
back from the investigator in Homestead was to the extent that
it is good that you did that, but as Dr. Osterholm said about
testing is that we are not going to test our way out of this.
The Chairman. No, I understand. I have a follow-up I am
going to ask you all, but I want to hear from Mr. Giclas and
then we are going to ask you a follow-up.
Mr. Giclas. Mr. Chairman, I don't have much to add. Mr.
Stenzel and Mr. Silbermann outlined the type of communication
between trade associations and the agency during the outbreak.
I can tell you that the types of questions that we got were not
very constructive questions. They were, what can you tell us
about distribution patterns, and we had to ask additional
questions about well, distribution patterns need to be outlined
a little bit more specifically before we can really answer
those. But we tried to answer any kind of question that was
raised by the agency during the course of the investigation.
What I can also tell you is that some of the questions that we
asked have been put off until this outbreak investigation is
concluded and behind us and we have an opportunity to sit down,
but they are important questions like what is failing in
traceback. We have heard over and over and over that traceback
systems are failing and we have asked for people to show us
where, how. If that is actually the case, industry wants to fix
that as quickly as possible because it is in everybody's best
interest to have those programs----
The Chairman. That is my understanding and experience as
well, sir, so that is my follow-up question is, oftentimes from
my colleagues, I get well, it is the industry, they just want
to protect their profits. They don't understand that protecting
their profits means not having outbreaks because the minute you
have an outbreak, you are devastated. It is the death sentence
for many of these farmers. And so my point is, how do we
communicate back from industry to FDA and CDC more effectively.
What I am told is, you are pretty much kept in the dark, asked
questions that sometimes may apply but your experience may be
much greater than the FDA's experience. What I found, is state
departments of agriculture oftentimes have much more experience
than the Federal Government either at USDA or at FDA. Can any
of you comment on that? And Dr. Osterholm, we will start back
and we will let you sum up.
Mr. Giclas. Well, I will be very brief. We would welcome
that. I think there are models, perhaps the Minnesota model
where there are state departments of agriculture that are
fundamentally involved. I know in California, they also involve
state departments of agriculture and those are the two states
that I know of that have the most robust traceback programs
today.
The Chairman. Mr. DiMare, quickly.
Mr. DiMare. Your question again?
The Chairman. What inputs and what methods could you better
provide FDA and CDC with information that they are not asking
the right questions?
Mr. DiMare. Well, in this case here, to me, go back to the
initial outbreak of April 10 and you look at the timeframe and
look at where tomatoes were coming or being produced at that
time of the year. You look at the initial outbreaks in New
Mexico and Texas, which seemed to have the most outbreaks, and
then Illinois. Knowing the distribution channels, knowing where
products come from for that particular time of the year. There
is no doubt in my mind the product didn't come from Florida,
whether it be tomatoes or jalapenos now. Again, you look at
those distribution channels where product is flowing from, that
is the thing that was frustrating for me.
The Chairman. If they are not ripe there, they are probably
not coming from there. That is your point?
Mr. DiMare. Yes.
The Chairman. That is pretty much common sense.
Mr. Silbermann.
Mr. Silbermann. Mr. Chairman, the letters that Mr. Stenzel
and I have written to Secretary Leavitt laid that out. I think
we really have to have a standing type of communication system
so that it is not just dealing with each crisis when it comes
up, and our written testimony deals with that too.
The Chairman. That is one thing that troubles me, sir, and
I know I am going way over my time. But, that is one of the
things that troubles me because I thought we had gotten past
some of this with the leafy green protocols, and we are going
to get to in just a moment Mr. Stenzel and Dr. Osterholm, then
I am going to turn it over to my colleagues.
Mr. Stenzel. I thought a lot about this. FDA is a
regulatory agency. They are the cops and they treat industry
like you are being investigated, like you did something wrong,
and maybe one person did but they are treating the entire
industry that way. I am going to suggest to the Energy and
Commerce Committee a new system to bring industry expertise
into the process ahead of time, to perhaps have a security
clearance, something by which the agencies could vet and clear
people who are experts. There are experts in jalapeno peppers
in growing and production and distribution that we still
haven't heard from, and we have to find a way to bring that
expertise in a way that the cops still feel comfortable with.
Mr. Costa. Would the gentleman yield?
The Chairman. Sure.
Mr. Costa. This precisely points to the question that I
asked the FDA spokesperson in the first panel, whether or not
they had people in the field that had expertise. I think it is
very clear that they don't have people, Mr. Chairman, in the
field that have expertise. They are spread too thin and this
most recent round of investigations points very clearly to
that. Your point, I think makes the most amount of sense.
First of all, all of these growers here are consumers. They
eat tomatoes. Their families and friends eat tomatoes. Number
two, if they send out products that are not good quality
products, healthy products, the market drops. I mean, they have
a vested interest. And so when I asked the FDA witness earlier
what regulations that prevented, as you said, a surgeon trying
to do surgery on a knee using arthroscopic and not being able
to see, you are being asked to provide information. You can
provide help. You want to get to the bottom of it. The quicker
you get this cleared, the better chance you restore confidence
of the American consumers to resume purchasing the product.
This is not rocket science. And so I appreciate your yielding,
but I think that clearly we have pointed out this afternoon
where the breakdown in this whole traceback process is that
needs to be fixed.
The Chairman. Well, Mr. Costa, I think you are absolutely
right, and the problem we are having, you, Mr. Mahoney, and I,
a lot of us have spent time on a farm. We spent time on a farm
and we spent time in the coffee shops and we hear the farmers
complaining about the fact that they can solve some of these
mysteries that sometimes happen very quickly because it is
common sense to them because they deal with it every day. But
that information is not percolating back to the bureaucrats in
Washington and it is what frustrates the heck of the American
population all the time. They are both being afflicted by an
outbreak, the industry is being destroyed and they are not
being able to help their government make the right call. That
is the problem that we are facing here.
Dr. Osterholm.
Dr. Osterholm. Mr. Chairman, I think that all the points
made are getting to a central point but I think they are
missing the point. The point is, the information that needs to
be added at a critical time like that critical ingredient in
the chocolate chip cookie dough is not the FDA. At the time
that you are trying to track back the product, you have already
identified a trend. You have identified a geographic set of
cases. You identified a time sequence. You have identified a
kind of restaurant or a location where it is purchased. That is
state and local public health at the CDC. That is where I think
the critical input is needed. In Minnesota, when I was State
Epidemiologist, every time we had an outbreak of any kind, the
first thing I did was assemble a group of local business
experts in that particular commodity whether it was red meat or
produce. More often that not, they helped solve it. By the time
this gets to the FDA for the traceback, in a sense the
footprint has already been set.
So I think I would support your point very much that this
input is needed. I think the industry folks are absolutely
right. In fact, many of the people down this table I have
talked to in past outbreaks where I was actually leading them.
I think the FDA, to follow up one point, has learned some
issues around traceback with this outbreak and I give them
great credit. I think the last days of the outbreak, they have
taken some different approaches and sped up their process and
actually I think to their credit have done quite a good job.
And let me just last comment, being a government bureaucrat
is obviously a tough job when you are in the crossfire, and I
do want to give Dr. Acheson great credit because I have had
great access to him to give my input and comments. I think that
he is trying but he has a whole system he has to deal with. I
think today that as much as we all want to find the reason why
things went wrong, it is not Dr. Acheson and I think we are
very fortunate to have him.
The Chairman. I hope I haven't given that impression. In
fact----
Dr. Osterholm. You haven't. I just want to be sure everyone
knows that.
The Chairman. Thank you, Dr. Osterholm. I agree with
everything you have said and what you have done. I am getting
ready to turn it over to Mr. Mahoney, but I have to say one
last thing. Early on in this hearing, I indicated that my wife,
the family doctor, said that public health is the fundamental
thing that we need to shore up in America, and I think you have
just made it even more clear that my wife was right again.
Mr. Mahoney.
Mr. Mahoney. And Mr. Chairman, you are always right.
I just have a couple of comments and questions. I mean,
unfortunately, I don't get to live in Minnesota so we are not
blessed to have this wonderful capability across the country. I
do agree with Dr. Osterholm in one perspective, and that is, I
think that the issue that is coming out today is really not
traceback, it is making sure that we are implementing the right
procedures and standards to make sure that the food is grown in
the proper way and being delivered properly to begin with. I
think traceback will happen if we implement a uniform system.
And it is also clear to me that unfortunately in this
particular example in the testimony given today by Dr. Acheson,
is that when we go down to Mexico and we are taking a look at
what is happening down there and the standards under which
produce is being grown, that there is a big inequity between
domestic production and foreign production and our ability to
keep track of it. So I think that that is something I will walk
away with.
One of the other things now I am concerned about, and I
guess I am going to start with Mr. DiMare, is that when I met
with my growers, and none of them were tomato growers, but when
I met with my growers in my district, I was asking them about
standards. It appeared to me that one of the things we are
dealing with is that the bigger producers are dealing with a
whole range of standards, some from the State of Florida,
others from big resellers, big buyers. Is that true? I mean,
how many--you know, you are operating in multiple states. I
mean, how many different sets of standards are you working
towards in terms of what you have to produce and what you have
to report?
Mr. DiMare. Well, you are right. There are many, depending
on what customer you are dealing with. Right now, we are
getting a lot of pressure because of this with customers
wanting to do pre-harvest pathogen testing, but there is no
scientific base or parameters right now to go by. This is part
of the problem I have with all of the testing is, you don't
have any true standards in place for industry to follow. And,
different customers are demanding different things at different
levels and that is very frustrating and----
Mr. Mahoney. Also very costly.
Mr. DiMare. It is very, very costly, and I guess that is
what we are trying to do through the associations is trying to
come up with standardization that is unified across the board.
So that, we are all complying with the same standards of
whatever the food safety audit, whether it is going to be
Primus based, whether it is going to be Davis Fresh, whether it
is going to be AIB, that the standard level be the same for all
producers across the board.
Mr. Mahoney. Let me ask another question to all of you, and
that is, I had the pleasure, I guess, now that I am no longer
involved in it, of being a small cattle rancher, never made any
money because all of my cows had first names, so I was at a
disadvantage. But when we were talking about immigration of
cattle and trying to understand how that works, I know that in
the cattle industry, a disproportionate amount of the cattle
produced in this country comes from small ranchers. One of the
concerns that I have as we move down this path in terms of
traceback, in terms of implementing systems of accountability,
is the small producer. One of the questions I would have for
you is, that if there are all of the different regulatory
aspects, whether imposed by the state, the Federal Government
or by large customers, what is your experience? What is the
ability for American agriculture to be able to deal with that,
not from just the perspective of the big producers but the
small farmer? And why don't we start with Mr. Giclas.
Mr. Giclas. Thank you, Mr. Chairman, Congressman Mahoney. I
think the industry is capable. Smaller growers tend to have a
relationship with their receivers. Larger growers tend to have
the more robust record-keeping and traceback programs in place.
There are legal requirements for everybody, going back to Mr.
Silbermann's comment about PACA, which is in the grower's best
interest to keep those records because that is how they ensure
that they are paid for their products. They have a motivation
to maintain and keep those records.
Mr. Mahoney. Mr. Silbermann.
Mr. Silbermann. I would just add that anyone who is packing
a vegetable product, let us say, in a box, would have the
capability of attaching the kind of label that we are talking
about, the standard label that has the three pieces of
information fairly easily. If they are going to have a packing
line, they certainly would be able to do that. But it is
definitely an issue for very small local growers who might be
delivering just to one or two stores. That is clearly an issue
that needs to be looked at.
Mr. Mahoney. By the way, I will just point out that one of
the things that I was just working with Wal-Mart on is the fact
that they are now having a new program where they are going to
reach out to local growers. I can tell you that in these tough
economic times, going to these farmers' markets, there is a lot
of people now that have decided that they are going to turn
their back 40, if you will, their half-acre, into an
alternative income source by growing vegetables and trying to
sell them. So I am seeing that happening.
Mr. Stenzel.
Mr. Stenzel. Two quick things on that. I think the small
producer is going to be able to put the information on the
case. For now, most of them do. It may be the company's name of
the farm's name, that type of thing, but as I said, anybody who
is packing a box of produce. The standardization effort that we
are trying to lead from an association standpoint just gets
everybody on the same numbering system. So there is an
education part of that, an outreach, but it is no more costly
than just putting information on the case. We think that would
go a long way.
I do want to mention one other thing though, when you talk
about a lot of small farmers coming in. One of the toughest
things we are going to have to do is help them as well with the
good agricultural practices to prevent illness because they may
not be part of other organizations and have had the education.
We have to make sure that anybody who is going to be growing
produce, even on a very small scale, meets those same food
safety standards and prevention.
Mr. Mahoney. One last question. Do we need to have more
aggressive oversight and making sure that foreign producers are
meeting our standards? Dr. Osterholm?
Dr. Osterholm. Congressman, can I just quickly answer the
last question too?
Mr. Mahoney. No.
Dr. Osterholm. Okay, because that is a key piece. You are
onto a very important issue beyond what you realize. I want to
answer.
Mr. Mahoney. I get in trouble if I go too long. I am a
freshman, so they only give me so much time.
Dr. Osterholm. Well, let me just tell you, that is an
important point because I think the small producer is going to
be a critical problem with food safety, and we have to
understand that right now, so I will just say that and leave it
at that.
Mr. Mahoney. Okay.
Dr. Osterholm. As far as the issue of the--I am sorry, your
second question?
Mr. Mahoney. Foreign producers.
Dr. Osterholm. Foreign producers. I think we have to be
very careful about that in the sense that yes, we do have
outbreaks with foreign producers. They have been a problem. But
again, if you are big and you can actually make the investment
into food safety, you can do it safely wherever you are at.
What I worry about is, as I said in my testimony. It is the
99.1 versus .9 percent rule, whatever. When you have the
industry, be careful how you label that. There are always a few
out there who are going to take and cut corners for costs. They
are the ones that more often than not have become the problem.
Mr. Mahoney. I have to tell you, I disagree with you,
because what I heard today from the FDA is the fact that they
are under-funded, under-sourced. They are not checking to make
sure that the growers are doing their job overseas and there is
very little oversight or inspection when these things are
coming in.
Dr. Osterholm. I don't disagree. What I am saying is----
Mr. Mahoney. And I am just saying, I take a look at my
tomato growers in Florida and I take a look at what the State
of Florida requires these folks to do and I think that it is an
alarming situation.
Mr. Stenzel.
Mr. Stenzel. Congressman, exactly what the State of Florida
and the tomato growers are being required is a self-motivated
process. Our tomato industry, and I don't want to speak for Mr.
DiMare or others here in the hearing room, has gone out of its
way to build those new processes and have the state inspect.
But that is precisely what we all want across all tomato
production regions including Mexico. It is not a matter of one
versus the other. Congressman Costa's bill and Congressman's
Putnam's bill would do precisely that, get to a common platform
for preventive control for all production. So I really think it
is important that the industry itself is asking for that
including the Mexican producers.
Mr. Silbermann. I would also add, Congressman, that many
large American producers are also producing products in Mexico
and taking some of the best practices to Mexico and requiring
that Mexican product is produced with exactly the same
standards. They have their own brand identity to protect when
their product is shipped, whether it is in Mexico or the United
States.
Mr. Mahoney. I don't think that is the problem. I think it
is the local producer.
Mr. DiMare. I would agree with that. I think it behooves us
as an industry to implement a program that is standardized,
whether it is domestically or in Mexico, because in this case,
as you can see, even if it wasn't a relation to your operation
tied to the outbreak, we all suffered fairly equally. So I
think it behooves us to make sure those standards are not only
passed on to the rest of this nation but certainly to all
imports coming into this country.
Mr. Giclas. I really don't have anything to add other than
to reinforce Mr. DiMare's point. We are only as strong as our
weakest link, and we would like to see everybody on the same
level playing field.
Mr. Mahoney. Can I ask one last question quickly?
The Chairman. Let me let Mr. Costa, and then we will give
you a whole other round if we need to. Mr. Costa.
Mr. Costa. Thank you very much, Mr. Chairman.
Mr. Stenzel, what percentage of your members would you say
today have electronic records to trace their products through
the distribution chain?
Mr. Stenzel. Gosh, I am going to have to estimate. I will
go back and try to get a better estimate for you. Electronic
interchange, the ability to have a computer record somewhere, I
would say more than 50 percent would have those records. I
think something earlier that was said, the PACA really has
produced a greater record-keeping for produce companies and
produce traders than most people realize. What we are lacking
in some areas is the ability for those computer systems to talk
to each other but the ability for an individual to do it is
there.
Mr. Costa. So a mandatory tracing effort, your industry
could adjust to it?
Mr. Stenzel. Well, adjust to and find a particular program
that makes the most sense. We have heard already today that
traceability was not the problem in this outbreak.
Mr. Costa. Right.
Mr. Stenzel. We know we can traceback. We can traceback
within, relatively, a matter of hours or days. The question
that will come is, what type of system and to what cost and
what benefit.
Mr. Costa. And that is why that is very important to all of
us because you had actually answered the question a moment ago.
I was going to ask, is there any legislation out here that has
been proposed that you think would address these issues that we
are talking about today. The answer was?
Mr. Stenzel. The answer is no.
Mr. Costa. There is no proposed legislation that has been
introduced that----
Mr. Stenzel. Well, with a little bit of encouragement----
Mr. Costa. That is a leading question.
Mr. Stenzel. I said a couple times that obviously the Safe
FEAST Act that you and Congressman Putnam have introduced we
believe takes care of that. It doesn't have the traceability
provision that Congresswoman DeGette's bill does but we don't
necessarily feel that that is the critical factor.
Mr. Costa. In terms of maximizing risk assessment versus
risk management to ensure public safety of health.
Mr. Stenzel. Absolutely. To ensure public safety, we have
to prevent the illnesses from ever occurring. Traceback is not
the problem.
Mr. Costa. Mr. DiMare, the tomato industry has made some
major advances, and the last time your industry had an
implicated food safety issue I believe was 2004. Would you like
to talk about the differences today between 4 years ago?
Mr. DiMare. Yes.
Mr. Costa. Very quickly, because I have one more question.
Mr. DiMare. Sure. What the Florida tomato industry has
implemented has been unprecedented in the produce industry. We
voluntarily as a group adopted a food safety program that is
going to be mandated by the State of Florida Commissioner of
Agriculture's office, and it covers all producers of tomatoes,
big and small.
Mr. Costa. So you think it is a model we ought to look at?
Mr. DiMare. I think it certainly is a model and other
states are currently looking at it.
Mr. Costa. Dr. Osterholm, I concur with you about the
impacts of, again it gets to be, and I have many of them in my
district and there are many cases of immigrants trying to live
the American dream, growing on a couple acres. But, they go and
there isn't the sort of safety requirements and standards and I
do think it is a potential problem when they drop off a load in
a small restaurant. The accountability and the thoroughness is
a question, at least for me, even though I certainly support
their efforts. As it relates to that, there has been discussion
about the epidemiology studies, and it is my understanding that
there aren't any standards for the questions that are asked of
individuals who got sick. How can you compare in terms of the
possible food eaten to find any commonality if you don't have
any uniformity in the data that is being collected? I think, is
at least in my mind, there seems to be an issue there.
Dr. Osterholm. Congressman, you are exactly right on
target, and that is part of what we propose to require of this
national system. There are efforts underway right now to help
improve upon that, an organization called CIFOR, which is a
combination of public health agencies trying to come up with
standards for this kind of investigation for when you move that
forward, and so I think you are exactly right.
Mr. Costa. So uniformity in the information required by the
states is something that we ought to be looking at in any
proposed legislation?
Dr. Osterholm. Well, uniformity to the extent that, think
of a criminal investigation. There is no one form you fill out,
there is no one set of pictures you take but there are certain
standards of how you gather evidence at a crime scene. Each one
is going to be different, whether it is in a building, whether
it is outside, whether it is in the middle of the summer or the
winter. The same thing is true with foodborne outbreaks. Each
one will be a little different but there should be uniformity
of standards and approaches that could be replicated whether
that happens in California, Minnesota, Texas or New York, the
same approaches would be taken, and that is what is being
attempted to be put in place now but it is not done.
Mr. Costa. Okay. That is very helpful.
Thank you, Mr. Chairman.
The Chairman. Thank you, Mr. Costa. I appreciate your
questions.
I have asked this question a couple different ways
throughout the day, and that is, how the fact that we have now
traced it back to Mexico, how many outbreaks there have been.
We are waiting for more of that information and we will be
compiling that information. But I think, Mr. Stenzel, I believe
it was your testimony, and I want to make this point as well,
that American farmers weren't the only ones that were affected
here, that there may be a lot of places in Mexico that grow
jalapenos or serranos. But, it was only one farm and all those
other farms in Mexico were implicated by regional name, but
weren't necessarily any worse than the American farmers on this
side of the border. So while I object when the protocols aren't
the same south of the border as they are north of the border
and where there are different pesticide regulations and there
are all the different issues that I have complained so
vigorously about other countries competing with our farmers on
a different playing field, different levels. How I believe that
our folks are subjected to the most rigorous standards, and I
support those standards, but how others may not have to do
that. I want to make the point very clearly and let you
comment, that Mexican farmers have been affected in a way as
well, that they have been affected by this recall the same way
as others have.
Mr. Stenzel. Thank you, Mr. Chairman. The bottom-line
message I would leave is that food safety is the responsibility
of the individual producer and they can get it right and they
can get it wrong and it doesn't really matter where they are.
We have to look at equivalent systems. We have to look at the
fair playing field and the same rules but ultimately food
safety is the responsibility of that individual producer.
The Chairman. Thank you.
Now, another question very briefly to Mr. Silbermann and
Mr. Stenzel, if the current traceback system works, what is the
rush on the part of industry players in moving forward with its
produce traceability initiative? Second, what is the timing of
implementation of that initiative? And third, Representative
DeGette's bill requires FDA to mandate traceability systems
that enable the Secretary to retrieve history use and location
of an article. I would like you to briefly comment on those
three questions.
Mr. Silbermann. Thank you, Mr. Chairman. Number one, the
produce traceability initiative began long before this current
outbreak, so please don't see this as a reaction to this
outbreak. It has been underway since the end of last year and
we have a desire to do this because it is going to take several
years to have complete implementation of this. I mean, it is a
long process because people have to get numbers from the
standards bodies, apply numbers and then build the system, so
we must get started. We understand that.
As far as a timeline for implementation, that will be
decided at the meeting on August 20 of the steering committee,
and we will make that available publicly once that has been
approved.
Finally, we believe that the degree of record-keeping that
already exists in the industry when married to this
electronically scannable information on every box will in fact
be in the best interests of the industry to require and buyers
have already committed that they are going to ask their
suppliers for this. Major buyers have already said we want to
have this information on the box. So I believe that industry,
the force of the market will drive adoption of this. I do not
believe at this time that regulation is required. I think that
regulatory authority already exists whether in PACA or in the
Bioterrorism Act.
The Chairman. Thank you.
Mr. Stenzel.
Mr. Stenzel. Quickly, we believe FDA already has the
authority to mandate any kind of traceability systems they
believe without legislation. Look at enforcement of the
Bioterrorism Act. What cases have been brought in any of the
concern about traceability that people were not complying? We
just don't see that as an issue. Why are we moving forward?
Standardization, efficiency across the industry. We think that
is important. We talked about the little stickers on the fruit.
At one time every grocery chain had a different numbering
system. They still could look up the cost of the produce. It
still worked. But we moved as an industry to standardize that
and that is what we are trying to do here, get all of our case
labeling on the same standard format.
The Chairman. I am going to actually turn it back to Mr.
Mahoney. You had one more question?
Mr. Mahoney. Well, no, I was just going to thank everybody
for coming because I recognize how difficult it is, and I guess
the last thing I was just going to ask is, I think it was Mr.
Stenzel that pointed out the fact that it has been an effort
with me and several of the Members to do some compensation. My
concern, of course, is that I believe that food safety and
national security are synonymous. We are down to two percent of
the population feeding the other 98 percent. This has been the
most expensive year in history to plant a crop and we need to
be figuring out, and one thing I love about the Agriculture
Committee is that we go to work every day trying to figure out
how to make agriculture stronger in this country and
profitability is one of the things.
So given the fact that crop insurance doesn't cover this,
is it a general consensus among the Members that there needs to
be some form of compensation or that would be justified in this
situation? Whether or not we can get it is another issue, but
we have to convince other Members to do this and I guess the
President at some point. But do you feel from an industry
perspective that this is warranted or merited? Why don't we
start with Mr. Giclas?
Mr. Giclas. We are here specifically to raise that issue so
we are very supportive of that, and I also agree wholeheartedly
that we need to look at mechanisms like crop insurance for
events like government action.
Mr. Mahoney. Mr. DiMare?
Mr. DiMare. Certainly from the producer's side, and I can
speak from a company standpoint, our losses as a total company
are approaching about $18 million, so again, as it was stated
earlier, this is not an action that was caused by us and
producers so there has got to be some accountability and
compensation.
Mr. Mahoney. Mr. Silbermann? Yes?
Mr. Silbermann. Yes.
Mr. Mahoney. Mr. Stenzel?
Mr. Stenzel. Yes, sir.
Mr. Mahoney. And Dr. Osterholm, you get the last word.
Dr. Osterholm. I don't have any comment except if we don't
fix the system, we are going to keep coming back, so help fix
the system and hopefully we can prevent these future needs for
additional compensation.
Mr. Mahoney. Good comment. Thank you very much. Thank you.
The Chairman. We really have to get to our next panel.
Thank you all for being here. Just as we are transitioning to
our next panel, I would like to say that Mr. Etheridge has
allowed me to say that he will be holding a hearing on
compensation and the questions in September when we come back.
Next up, with the patience of Job, I will call up, because
they have been waiting an awful long time, James Gorny, Ph.D.,
Executive Director, Postharvest Technology Research and
Information Center at the University of California at Davis,
and Ms. Jean Halloran, Director of Food Policy Initiatives,
Consumers Union, Yonkers, New York. Thank you so much for both
of you being here. It has taken a long time to get to your
testimony but that makes it no less important to me. So please
proceed with your verbal statement, Dr. Gorny.
STATEMENT OF JAMES R. GORNY, Ph.D., EXECUTIVE
DIRECTOR, POSTHARVEST TECHNOLOGY RESEARCH &
INFORMATION CENTER, UNIVERSITY OF CALIFORNIA-DAVIS, DAVIS, CA
Dr. Gorny. Thank you, Mr. Cardoza. Thank you for the
opportunity to be here. As you said, I am Dr. Jim Gorny. I am
with the Postharvest Technology Research and Information Center
at the University of California at Davis. Our center's mission
is to reduce postharvest losses and enhance the quality, safety
and marketability of fresh horticultural crops.
First and foremost, I want to express my sympathies to all
who have been adversely affected by this foodborne illness
outbreak and to say I hope to provide at least some small
assistance to this Subcommittee to enhance the consumer and
marketplace confidence in our nation's food supply.
I am going to echo a lot of the themes that were heard
earlier today. First and foremost, enhanced produce
traceability may certainly play an important role as a means of
bolstering the safety of our food supply but by no means should
it be seen as a panacea. Traceability and recall procedures
must be viewed as the last line of defense, not the first line
of defense, in preventing foodborne illnesses.
Today I would like to address current industry practices
and possible means of enhancing the health and safety of our
food supply in America in general. First and foremost, with
regard to current handling practices, we have heard a lot today
about the Bioterrorism Act. Both in the Code of Federal
Regulations and specific provisions of the Bioterrorism Act
require traceability by everyone up and down the food supply
chain. The rules promulgated by FDA regarding the Bioterrorism
Act do require that everyone in the supply chain within a
reasonable amount of time, meaning less than 24 hours, be able
to tell who they received product from and who they
subsequently shipped product to. These rules promulgated by FDA
do not specify a uniform reporting format, they do not require
electronic record-keeping and they do not prohibit commingling
of food products. As has been mentioned earlier, while FDA has
reported numerous difficulties in the recent traceback
investigation, to my knowledge, no enterprise has been found to
be in violation of the Bioterrorism Act provisions regarding
record-keeping.
Now, commingling of food by various suppliers is not unique
to the produce industry. It happens also, for instance, in lots
of baking flour which may be commingled in storage silos, so
why does the produce industry commingle produce? For example,
tomatoes are picked at a mature green stage and basically they
are shipped off in long distances to the marketplace for
ripening and size sorting before being shipped to grocers and
restaurants. Green tomatoes simply ship much better. They
bruise less easily and there are less postharvest losses. The
ripening and size sorting of tomatoes does occur at repacking
operations and it offers a real value-added service to
retailers and restaurateurs because no consumer wants to eat a
small green tomato on their sandwich or on their hamburger.
Now, because tomatoes are often not uniform in size and
ripeness when they are picked, there may be insufficient
quantities in any given lot to meet customer demands or needs
so there will be commingling at the repacking facility to meet
grocer and restaurateur needs.
We also talked a lot about epidemiology today and I would
like to discuss that in a little bit of detail. Epidemiology is
all about finding commonalities to ultimately determine where
tainted food came from, how it got contaminated and prevent
occurrences in the future. Undoubtedly, tomato commingling can
confound an investigation, but in this case, it seems to be
imperative as we move forward to determine if produce
traceability did work or didn't work. Was the lack of
commonality or patterns in the tomato traceability
investigation simply indicated that tomatoes were not the
tainted food causing the illnesses.
Now, in fact, we know that it is jalapenos and again, I
would like to address how the Minnesota Department of Public
Health broke this case. They used different agencies. They used
the Department of Agriculture in Minnesota, and it points out
the benefits of public health agencies collaborating with other
agencies.
Can traceability be improved? Yes, absolutely, and we heard
from the industry today talking about their GTIN initiative
with regard to electronic records. It will certainly provide a
common electronic language for produce traceability.
Last but not least, with regard to protecting public health
and some recommendations, the food industry, government and the
public should be very concerned about public health officials'
lagging response time and inability to quickly identify what
food is making people sick. Broad advisories by the FDA to
consumers not to consume certain foods should be a regulatory
tool of last resort to protect public health. It is a huge
disincentive for private enterprises to invest in robust food
safety programs and traceability systems if they offer no
protection to industry-wide shutdowns by broad public health
advisories. In short, a focused approach is what is needed, and
more resources and cooperation are what is needed.
I am going to sum up a few specific recommendations. First
and foremost, I think we have heard today we need increased
understanding by public health officials regarding how specific
food industry sectors produce, process and handle and
distribute foods. The University of California at Davis stands
ready to assist CDC and FDA in helping them understand how the
produce industry works. We need development of a harmonized
approach to foodborne illness outbreak investigations among the
various agencies at the Federal and state level. An agency
should engage academia and industry personnel as well as
government who have specialized working knowledge about
industry segments. We need increased capacity building at FDA
and CDC, as Dr. Osterholm talked about. We need increased
transparency to understand and have confidence in the CDC and
FDA's decision-making process regarding foodborne illness
outbreak investigations. And last, we need accelerated
harmonization of the traceability initiative by the industry.
In conclusion, it is imperative that we all work together
to ensure the safety of fresh produce because these foods play
such an important and central role in maintaining good health
of our population.
I would like to thank you for the opportunity to address
the Subcommittee and provide my professional perspectives.
Thank you.
[The prepared statement of Dr. Gorny follows:]
Prepared Statement of James R. Gorny, Ph.D., Executive Director,
Postharvest Technology Research & Information Center, University of
California-Davis, Davis, CA
My name is Dr. Jim Gorny and I am Executive Director of the
Posharvest Technology Research & Information Center at the University
of California in Davis, California. The Postharvest Technology Center
is made up of a multi-disciplinary team of researchers and extension
educators, with a common mission to reduce postharvest losses and
enhance the quality, safety and marketability of fresh horticultural
crops. The Center specializes in providing research-based information
to stakeholders to assist them in making informed decisions about
produce handling practices.
The foodborne illnesses recently associated with produce are a
tragic occurrence and my sympathies go out all of those who have become
ill. We can never forget the real human impact when something goes
wrong in our food safety system. I am glad to be here to assist in
developing solutions to enhance consumer and marketplace confidence in
our nations food supply.
I would like to address two issues today.
First, I want to address current produce industry handling
practices and their implications for traceability in the event of a
foodborne illness outbreak.
Second, I want to share with you views regarding possible means of
protecting public health in the future.
Enhanced produce traceability may certainly play an important role
as a means of bolstering the safety of our food supply, but it is not a
panacea as other issues also need attention. Traceability and recall
procedures are the last line of defense in preventing foodborne
illnesses.
1. Current Industry Handling Practices
Legal Requirements: The Bioterrorism Act of 2002 and other
provisions of the Code of Federal Regulations require food product
traceability. Specifically the Bioterrorism Act of 2002 requires that
records be kept for one step forward and one step back product
traceability by everyone in the supply chain.
Rules promulgated by FDA regarding the Bioterrorism Act:
Do require that everyone in the supply chain be capable in a
timely manner (within 24 hrs of notice) of identifying
suppliers of food products and/or ingredients and to know to
whom product has been subsequently shipped;
Do not specify a uniform reporting format;
Do not require electronic record-keeping;
Do not prohibit commingling of food products or ingredients.
While FDA has reported numerous difficulties and specifically
tomato commingling, in this recent traceback investigation, to my
knowledge, no enterprise has been found by the FDA to be in violation
of Bioterrorism Act provisions regarding record-keeping.
Commingling of food from various suppliers is not unique to the
produce industry, another example would be lots of flour for baking
which may be commingled in storage silos. The practice of commingling
tomatoes has been reported by the FDA to be particularly problematic in
hampering their recent investigations to identify the cause of the
recent Salmonella Saintpaul foodborne illness outbreak. So why does the
produce industry commingle produce.
Current Industry Practices: Tomatoes are commonly picked when they
are at the mature green stage of ripeness. These green tomatoes are
then shipped, often long distances near to the marketplace for ripening
and sizing sorting before being shipped to grocers and restaurants.
This is done because green tomatoes ship much better than ripe tomatoes
that are very susceptible to bruising and postharvest losses. Ripening
and repacking operations which ripen and size sort tomatoes offer a
very real value added service because no consumer wants to purchase of
consume a small green tomato on their sandwich or hamburger.
Because tomatoes are not uniform in size and shape and there may be
insufficient quantities of tomatoes from any one lot, different lots of
products may be commingled and then sent to grocers and restaurants.
Salmonella Saintpaul Foodborne Illness Investigation
Determining in an epidemiological investigation where tainted food
came from (which store, then which distributor, then which grower/
shipper/packer) by identifying commonalities among where ill
individuals purchased their food, is critical to ultimately identifying
the most likely root cause of contamination and thus providing the
possibility of making sure such contamination never occurs in a similar
manner again.
Epidemiology is all about finding a common thread and traceback is
only a part of the epidemiological investigation.
Undoubtedly, commingling as in the case of tomatoes has the
potential to confound and hamper traceback investigations. In this case
it will be important to determine if produce traceability did or did
not work and if the lack of commonality or patterns in the tomato
traceback investigation simply indicated that tomatoes were not the
tainted food causing the illnesses.
Epidemiologists when investigating a foodborne illness outbreak
must be extremely careful in assuring that the link between what ill
persons ate and where they purchased that food item from is factually
correct. If a false assumption is made early in the investigation
process (i.e., wrong food product or wrong point of purchase) it leads
the epidemiological investigation down the wrong distribution chain,
thus wasting time, resources and ultimately delaying the identification
of the true cause of the illnesses.
It has now come to light, that in fact jalapeno peppers are the
most likely food product responsible for this recent almost nationwide
salmonellosis outbreak, through epidemiological evidence gathered by
the Minnesota Department of Public Health and jalapeno peppers samples
testing positive for the presence of Salmonella Saintpaul with a
similar genetic fingerprint to the outbreak strain.
It is interesting to note is that in an AP news report on July 24,
2008, reporting about how jalapeno peppers were identified as like
cause of this foodborne illness outbreak Ben Miller of the Minnesota
Department of Agriculture said, ``A few phone calls and you can work it
fairly quickly back to the grower''. This seems to point out the
traceability does seem to be working in the produce industry and it
also points out the benefits for public health agencies to use allied
agencies with complimentary expertise during investigations.
Can traceability in the produce industry be improved? Absolutely
yes, the produce industry does have an opportunity to more effectively
aid public health investigations into foodborne illness outbreaks by
having a uniform format of electronic records. This task developing and
adopting a harmonized format of electronic records for traceability has
actually already been initiated by a joint task force of produce
industry trade associations. This group is working on development and
use of what is called Global Trade Item Numbers (GTIN) which provides a
common electronic language for traceability for the produce industry.
2. Protecting Public Health
The food industry, government and the public should be concerned
about public health officials lagging response time and inability to
quickly identify what food is making people ill.
First and foremost public health agencies are currently fragmented
and under-resourced to effectively monitor and respond rapidly to
developing public health issues. Each and every foodborne illness
outbreak investigation is an opportunity to enhance investigation team
response time.
Broad advisories by FDA to consumers not to consume certain foods
should be a regulatory tool of last resort to protect public health. It
is a huge disincentive for private enterprises to invest in robust food
safety programs and traceability systems, if they offer no protection
against industry wide shut downs by broad public health advisories. A
more focused approach is needed to protect public health and commerce.
This recent foodborne illness outbreak has tarnished FDA's reputation
and credibility with consumers and businesses alike, many of whom
continued to sell and consume jalapeno peppers despite FDA's blanket
advisory against their consumption. This is simply unprecedented and
paradigm shift in how people perceive the FDA's public health
recommendations.
Simply put more resources and cooperation are needed to adequately
protect public health and commerce.
Specific recommendations include,
Increased understanding by public health officials regarding
how specific food industry sectors produce, process, handle and
distribute food products.
Development of a harmonized approach to foodborne illness
outbreak investigations among various Federal and state public
health agencies. Agencies should also consider engaging
academia and industry personnel whom have special working
knowledge about food industry segment practices during an
investigation.
Increased capacity building at FDA, CDC and state public
health agencies, in terms of trained professions to respond to
foodborne illness outbreaks.
Increased transparency to understand and have confidence in
the CDC and FDA decision making process regarding foodborne
illness outbreak investigations.
Accelerated adoption of a harmonized traceability format
Global Trade Item Numbers (GTIN) electronic traceability format
for the produce industry.
In conclusion, it is imperative that we all (academia, industry and
government) work together to assure the safety of the fresh produce
supply because these foods play such an important and central role in
maintaining good health.
Thank you for this opportunity to address the Subcommittee and
provide my professional perspectives on this issue.
The Chairman. Thank you, sir.
Ms. Halloran.
STATEMENT OF JEAN HALLORAN, DIRECTOR, FOOD POLICY INITIATIVES,
CONSUMERS UNION, YONKERS, NY
Ms. Halloran. My name is Jean Halloran and I am Director of
Food Policy Initiatives for Consumers Union, the nonprofit
publisher of Consumer Reports, and I suppose there is always
something to be said for having the last word.
The Chairman. My kids always try and get it, so I know it
is important.
Ms. Halloran. This foodborne illness outbreak involving
Salmonella Saintpaul in produce, which has now been linked to
peppers grown in Mexico, shows quite clearly that traceability
offers a way to protect consumers better, use our regulatory
resources more efficiently and effectively, and limit the
losses of produce growers.
We believe that had a good traceability system been in
place for tomatoes 4 months ago, and I would like to say that
traceability is something supported by 86 percent of consumers
in a recent AP-Ipsos poll, had that been in place, FDA would
have gotten to the bottom of this problem much more quickly.
With traceability, investigators could more quickly have
followed what people were eating back trough the distribution
chain and all its repacking and remixing stages, could more
quickly have sampled along that chain, and could more quickly
have understood that tomatoes were most likely not the primary
source of the problem. This could have helped FDA and CDC turn
their attention sooner to foods eaten in association with
tomatoes and thus to the jalapenos that we are now considering
so seriously.
We see two options for upgrading traceability. At a
minimum, we believe that products should have labels on the
packages and boxes and where possible on the product itself
that show the country, facility, date and time where the
product was first processed and shipped. I was very encouraged
by the testimony of the Produce Marketing Association that they
have such a scheme in process. It is essential that this be
mandated for everyone and not just be voluntary because it is
the gaps that will cause the problem and slow down a traceback
process. This can be implemented on the very same stickers that
will show a product's country of origin, which is going to be
mandatory for imported produce in October of this year.
Even more effective is what we call the FedEx model in
which each product gets a code on it that can be read as the
product moves through the process and will enable it to be
tracked through the distribution system. Then if you come up
with a contaminated pepper, you could look back and see all the
places it has been and all the places it might have been
contaminated or contaminated something else. We know that there
are important issues to resolve here including ensuring that
all handlers log in and log out shipments and also whose
computer will process all this tracking data. But, we do
believe that Congress should mandate full traceability on the
FedEx model, and unless it is mandated, you will not get
compliance with foreign producers and small producers. I would
say for very small producers, this is not really an issue
because if something goes direct from the producer to a
farmer's market, you don't need traceability. There is nothing
to trace. You are buying from the producer.
The Chairman. Both the consumer and the producer know who
did it, right?
Ms. Halloran. Yes. The alternative to these options is the
present situation with the consequences we have just been
discussing. I would like to emphasize that FDA has no choice
but to inform the public when it has strong suspicions about
contamination. Consumers need to be able to take precautionary
actions to protect themselves in such situations and FDA cannot
withhold information from them that would better allow them to
take precautions for themselves and their loved ones.
Therefore, we must learn to prevent these situations and to not
have the investigations drag on.
In addition to traceability, we feel that other preventive
measures are really important, as others have stated. One is a
substantial increase in resources for FDA. Another is FDA
should be required to develop standards for processing
facilities. A third is that FDA should be required to enforce
clear performance standards for contaminants in produce. USDA
data, a recent study shows that there are higher levels of
pesticides in imported salad vegetables than in domestic, so we
need enforcement of standards. FDA is not enforcing
sufficiently at the border. They said only one percent was
being looked at. They visit facilities only once every 5 to 10
years, foreign facilities even less frequently, although we
believe they need it more. Finally, they should have mandatory
recall authority and disclose the stores that carry recalled
products.
This Congress has much to do and little time to do it in
but we think these issues are urgent and we urge you to tackle
these issues now. Thank you.
[The prepared statement of Ms. Halloran follows:]
Prepared Statement of Jean Halloran, Director, Food Policy Initiatives,
Consumers Union, Yonkers, NY
Thank you for the opportunity to testify today on traceability and
its potential use in fresh produce. My name is Jean Halloran and I am
Director of Food Policy Initiatives for Consumers Union, nonprofit
publisher of Consumer Reports.
This is a timely and important hearing because we are still in the
midst of a serious foodborne illness outbreak involving Salmonella
Saintpaul in produce, which has now been linked to peppers grown in
Mexico.\1\ This outbreak shows quite clearly that traceability offers a
way to protect consumers better, use our regulatory resources more
efficiently and effectively, and limit losses of produce growers when
food safety problems emerge.
---------------------------------------------------------------------------
\1\ FDA Statement, ``U.S. Grown Jalapeno and Serrano Peppers Not
Connected to Salmonella Saintpaul Outbreak,'' July 25, 2008.
---------------------------------------------------------------------------
We are now in an era of a globalized food supply. Food products
move around the United States and are imported from other countries as
never before. Unfortunately our systems for insuring the safety of food
have not kept up with the changes in production and distribution
systems. Congress can and should address the need to modernize FDA to
deal with these new challenges. We urge you to require full
traceability as part of this much needed overhaul. Consumers
overwhelmingly like this concept: an Associated Press-Ipsos poll shows
that 86 percent of consumers support traceability.\2\
---------------------------------------------------------------------------
\2\ http://www.latimes.com/news/nationworld/nation/wire/ats-ap-ap-
poll-food-safetyjul20,0,428028.story.
---------------------------------------------------------------------------
Food Safety Incidents
We are now facing significant problems as to the safety of our
food. The current tomato/jalapeno Salmonella Saintpaul outbreak is just
latest example. This foodborne illness outbreak has sickened more than
1,200 people, sent more than 200 to the hospital, and contributed to
two deaths. As is usually true in such disease outbreaks, the deaths
tend to affect the very young, the very old and those with compromised
immune systems, and in this case the Salmonella contributed to the
deaths of two elderly gentlemen.\3\
---------------------------------------------------------------------------
\3\ http://www.cdc.gov/salmonella/saintpaul/.
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This outbreak follows several others in the last 2 years that have
involved significant numbers of illnesses, including Salmonella in
peanut butter,\4\ where the problem originated in a Georgia processing
plant, and E. coli in spinach, where the contamination apparently
occurred on a California farm.\5\ There have also been problems with
prohibited chemicals in seafood, stemming from use of the chemicals at
aquaculture facilities in China.\6\
---------------------------------------------------------------------------
\4\ FDA News, ``FDA Warns Consumers Not to Eat Certain Jars of
Peter Pan Peanut Butter and Great Value Peanut Butter Product May be
Contaminated With Salmonella,'' February 14, 2007.
\5\ FDA News, ``FDA Finalizes Report on 2006 Spinach Outbreak,''
March 23, 2007.
\6\ FDA News, ``FDA Detains Imports of Farm-Raised Chinese Seafood;
Products Have Repeatedly Contained Potentially Harmful Residues,'' June
28, 2007.
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The tomato/jalapeno case is still not resolved, in that the Food
and Drug Administration and the Centers for Disease Control have so far
not traced the problem back definitively to its source or sources.
Until they are able to do that, we cannot be sure that the outbreak is
over, or that it will not start up again. Although some 1,200 cases
have been officially reported to CDC, it is likely that many more
people have been and could still be affected. Experts estimate that for
every reported case in an outbreak of this type, three to ten times as
many people may be affected, but are not counted because they don't see
a doctor, or their doctor doesn't seek to identify the bacterium
causing their problem.
This case in particular has highlighted the need to establish
traceability systems in produce. FDA's original hypothesis, based on
case control analyses by CDC of what victims ate, was that tomatoes
were the problem food. FDA then began the extremely labor intensive
process of trying to traceback the tomatoes that the people had eaten,
hoping to find the source of their Salmonella infection. Unfortunately
they found that tomatoes go through many hands and are mixed and
repackaged often. Thus trying to traceback one person's tomato became
an enormous task, with trails branching again and again. The mystery
dragged on for weeks, resulting in confusion for consumers and hundreds
of millions of dollars in losses for our nation's tomato growers.
We believe that had a good traceability system been in place for
tomatoes 4 months ago, FDA would have gotten to the bottom of this
problem much more quickly. With traceability, FDA investigators could
much more quickly have followed what people ate back through the
distribution chain, could much more quickly have sampled along that
chain, and could much more quickly understood that tomatoes were most
likely not the source of the problem. This would have helped it turn
its attention earlier to foods eaten in association with tomatoes, and
thus to jalapenos where last week the Salmonella strain was identified.
Options for Traceability
We currently have very limited traceability for food, which are not
sufficient. The current system, wherein those in the produce industry
keep paper records that indicate one step forward and one step back in
the supply chain, creates an enormous amount of work for any regulatory
agency trying to follow a trail.
We see two options for upgrading traceability at this time. One
would be relatively easy to implement. We believe that at a minimum, we
should have labels or marks on produce packages and boxes, and where
possible on the product itself (such as with fruit), that show country,
facility, date and time where the item was first processed or shipped.
The label or mark should allow the product to be traced all the way
back to the farm. This can be implemented in the form of a numerical or
bar code on the very same sticker that will already show the product's
country of origin--which is mandatory for imported products in October
of this year. Such facility/date/time of processing information was
present on the packages of bagged spinach that were found to contain
dangerous E. coli in 2006, and it allowed FDA to quickly--within a
couple of weeks, instead of months--identify and isolate the source of
the contaminated spinach.
An even more effective option, though somewhat more difficult to
implement, is what we think of as the ``FedEx model.'' In this model,
each lot being shipped would get a label like that on a FedEx package
that would enable its progress to be tracked throughout the food
distribution system. Then if you had a contaminated pepper, you could
look back and see all the places it had been, and therefore all the
places it could have been contaminated. We do understand that there
would be many issues to resolve to implement such a system, including
how to ensure that all handlers log in and log out their shipments, and
whose computer would process all the tracking data on shipments in
process. Still, if FedEx can do it, why not the tomato industry?
The alternative to implementing one of these options is the present
situation where it is enormously difficult for FDA in certain cases to
pinpoint the source of an outbreak. This has unfortunate consequences
for consumers, the regulators and the industry. First, FDA wastes
enormous financial resources getting to the bottom of the problem.
Second, FDA has no choice but to inform the public when it has strong
suspicions about contamination--as it did in the case of tomatoes--even
though we know that an initial hypothesis, no matter how sensible and
justified, may turn out to be incorrect. FDA must do this because not
to do so would be irresponsible. Salmonella, E. coli and Campylobacter
infections can all result in deaths, particularly of the most
vulnerable such as young children, the very old, and the sick.
Consumers need to be able to take precautionary actions to protect
themselves in such situations, and FDA cannot withhold information from
them that would better allow them to protect themselves and their loved
ones. But consumers may needlessly discard good produce and avoid
healthful foods as a result, and growers may experience enormous
financial losses.
To prevent such precaution-taking from having a devastating impact
on an industry, FDA must be able to get to the bottom of a problem
quickly and efficiently. To do this we need product traceability.
Additional Reforms Needed
As much as traceability will help, however, the ability to
traceback in response to a disease outbreak is not the whole solution.
FDA should be acting proactively to prevent these outbreaks from
occurring in the first place. FDA also needs other enhancements to its
resources and authority to be able to prevent as well as respond to
food safety problems effectively. We urge Congress provide the
following so that FDA can function as a 21st century food safety
agency:
A Substantial Increase in Resources: Significantly
increasing appropriations for the agency is essential.
Registration fees can also provide revenue, although they
should not substitute for appropriations.
Process Controls: Companies should build safe practices
directly into production. Production facilities should be
required to develop and use written food safety plans to
identify hazards likely to occur in their facilities, and then
implement measures to reduce those hazards. FDA should be
required to develop standards for process controls in areas
like tomatoes and leafy greens that have caused disease
outbreaks.
Strong Food Safety Standards: Contamination can occur at
many points along the food chain, including production,
processing, shipping, or handling. Such contamination can
include bacteria, illegal antibiotic residues, heavy metals,
and pesticides. FDA must establish and enforce clear
performance standards for food products to reduce the risk of
contaminated food being released into the marketplace.
Traceability: As the recent Salmonella outbreak has
demonstrated, we desperately need to be able to trace our food
throughout the supply chain when an outbreak occurs.
Food Facility Inspection: Between 2003 and 2006, FDA
domestic food safety inspections decreased 47 percent.\7\ On
average, domestic food production facilities are inspected once
every 5 to 10 years, foreign facilities even less frequently.
Congress should require FDA to create a risk-based system of
routine inspections, based on the type of food produced, how it
is processed, and history of the plant and region or country
where it is located, among other factors. All facilities
regulated by the FDA, foreign and domestic, should be subject
to mandatory, regular inspection by officers of the FDA.
Higher-risk facilities should be inspected on a more frequent
basis--at a minimum once a year--and all facilities must be
inspected at least once every 2 years.
---------------------------------------------------------------------------
\7\ Associated Press, ``Risks of tainted food rise as inspections
drop; Amid high-profile scares, FDA safety testing has fallen by half
since 2003'' February 26, 2007.
FDA Border Inspections: FDA inspects less than one percent
of food imports at the border. This must be significantly
increased, especially for high-risk foods. For example, the
European Union physically inspects either 20 percent or 50
percent of all imported seafood shipments, depending upon the
risk of the individual product.\8\
---------------------------------------------------------------------------
\8\ Food & Water Watch, ``Import Alert: Government Fails Consumers,
Falls Short on Seafood Inspections,'' FWW report, May 2007, at 6.
Mandatory recall authority and disclosure of retail
consignees: When FDA discovers a problem, it is forced to ask
companies to voluntarily recall an unsafe product. It is
important that FDA be able to act quickly in such situations
and order a mandatory recall. FDA should also be required to
inform consumers of all retail outlets, schools, nursing homes,
---------------------------------------------------------------------------
etc. that are involved in a recall.
Although this Congress has much to do and little time to do it in
at this point, this problem is urgent. We urge Congress to tackle it
now, and require full traceability as part of a significant overhaul of
FDA's regulation of food safety.
The Chairman. Thank you, Ms. Halloran. Thank you very much
to both of you. I have a couple of questions that I want to
ask.
First of all for Dr. Gorny, do you believe adoption of the
Global Trade Item Number, GTIN, electronic traceability format,
should be accelerated? You also have acknowledged that one of
the most difficult aspects of creating that traceability
program is dealing with the issue of commingling of produce at
different stages along the way. Does this format provide
appropriate level of granularity to address the current risks
and concerns?
Dr. Gorny. First and foremost, I believe that the GTIN
standard that is being put forward by the trade groups in
produce will be a huge step forward, a great leap forward with
regard to the ability to trace product. The reason being that
it puts it on a common format and an electronic format, exactly
what FDA has said has been a huge problem with regard to these
traceback investigations. The second part of your question is,
I think if we provide--you are never going to get away from
commingling of produce. You are never going to get away from
commingling of all food products. You just have to deal with
that at a most appropriate level, and it is at a per-box level
so you know that potentially two potential suppliers may have
put product into that potential box, and I think it is possible
to closely segregate, so I think it is a huge step forward.
The Chairman. Thank you.
Ms. Halloran, your recommendations for traceback systems,
do you envision establishing a single traceback system for all
food products or do you see different systems for different
products?
Ms. Halloran. I am not certain of the most appropriate
method. I think it may well be for different industries you
need different systems and they may need to be maintained by
industry associations or other entities, but you need a uniform
framework. There needs to be uniform criteria for how this is
done so that there are certain minimum criteria and that FDA
can use them simply and don't have to learn a new system every
time.
The Chairman. During the farm bill discussion, I had
serious conversations with the Chairman of the Senate
Agriculture Committee, Mr. Harkin. We tried to figure out how
we were going to do this and there is a genuine commitment on
his part to wanting to move along these lines. We had a method
in the House bill that he didn't feel comfortable with. One of
the arguments that I made to him was, there are 350-some
commodities in the food world but within those there are so
many subsets, different types of varietals, and to develop
different protocols for each one of those on food safety
measures is very difficult. The industries that do that though
can individually can come up with it. So we were having a very
difficult time. My question for Ms. Halloran is, should FDA
start by establishing a traceback system for high-risk products
or handle all products simultaneously, knowing that it is very
complex and the record of agencies developing regulations and
protocols is not that great in this country? It takes a long
time. I think the quickest one we have ever seen is 18 months
to 2 years, and you multiply that times 350 and you are looking
at the next century before we will finally get to food safety
by that criteria. I think we can do it another way but I would
like to hear your testimony.
Ms. Halloran. Yes, I think that to have FDA try to
micromanage this would be probably a mistake, and that some of
the basic--the three things that the produce manufacturers were
talking about--we were thinking, basically four facts, the
country of origin, the facility of origin, the date and the
time of the shipment for the original product. If that ended up
on that sticker that annoyingly we are always pulling off as
the consumer, that would be a huge leg up on the traceback
process, would be very simple to do and all you need is a
numerical system that is common to everyone which obviously the
produce industry is already well in the process of developing.
The Chairman. Thank you. I appreciate your acknowledgement
of that. Frankly, I think that our farmers and our distributors
in this country have done a miraculous job producing the
volumes they do at the costs. Even at the higher costs that we
are now seeing in the supermarket, we are certainly lower than
most parts of the world and pay less for our food than most
parts of the world do, and it is, in my opinion, safer than
many parts of the world. It is not always safe but it is safer
than what is typically, in my opinion, available in many parts
of the world. But that is my editorial comment.
Ms. Halloran. I really have to say, I think we can say we
have one of the safest food supplies in the world. I really do
think that, for example, many countries of the European Union
are now ahead of us, if you look at the statistics, so we
really don't want to lose our edge on that area and we have
some work to do to keep up.
The Chairman. Thank you. At this point, I want to thank you
both for your testimony. I want to thank all our panelists. I
want to thank the audience. I want to give a special thanks to
the staff, both the Minority and the Majority staff, who have
done a fabulous job preparing this hearing and getting all our
witnesses here today.
Under the rules of the Committee, the record for today's
hearing will remain open for 10 days to receive additional
material and supplementary written responses from the witnesses
to any question posed by a Member of the panel. This hearing of
the Subcommittee on Horticulture and Organic Agriculture is
hereby adjourned.
[Whereupon, at 5:40 p.m., the Subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Submitted Testimony of Jesse Driskill, President, Fresh Produce
Association of the Americas
August 1, 2008
Hon. Dennis A. Cardoza,
Chairman,
Subcommittee on Horticulture and Organic Agriculture,
Committee on Agriculture,
Washington, D.C.
Re: Written Hearing Testimony Submitted for the Record on Behalf of the
Fresh Produce Association of the Americas; House Agriculture Committee,
Subcommittee on Horticulture and Organic Agriculture Held on July 30,
2008
Dear Chairman Cardoza,
On behalf of the Fresh Produce Association of the Americas, a trade
association representing more than 125 member importers of produce
located in Nogales, Arizona, we would like to submit this written
testimony for the record. FPAA was founded in 1944 to represent the
U.S. importers of produce from Mexico, an industry that is a vital part
of the U.S. border and regional economy, the port of Nogales imports
$1.5-$2.5 billion annually. Our industry provides jobs and contributes
significantly to the U.S. economy, particularly in the southern border
region of the United States, but also down the supply chain including
distributors, retailers and restaurants. In the context of this
hearing, it should be noted that FPAA also represents the majority of
the distributors and importers of tomatoes from Mexico. With all due
respect, we would like to suggest that for future hearings on food
safety for produce that FPAA be included as a witness. Based on our
long history in the business, we have many facts and practices to share
about food safety from the unique importer position in the market.
At the outset, we would like to thank Chairman Cardoza for holding
this balanced, fair and positive hearing seeking solutions and
improvement in the area of food safety for produce. In this important
area, where confidence of the U.S. food supply is at issue, we cannot
indulge in finger pointing but must move forward together to ensure
consumer confidence in our products. Produce is a healthy product,
essential for a healthy diet. At a time when obesity and related
illnesses are costing consumers and the U.S. taxpayers as much as
billions of dollars annually in healthcare costs, we must not
discourage consumption of fresh produce. In the recently passed farm
bill, the Congress wisely funded the U.S. school snack program at a
level of about $1 billion annually to provide fresh produce to under-
privileged children with the goal that child nutrition and long-term
eating habits would be established for the U.S. population in years to
come. We cannot let unwarranted fears undermine this progress toward
improved nutrition. For these reasons, it is important that we improve
the FDA-CDC response to outbreaks and ensure balance in communication
about risk.
With regard to produce, we view the industry as the North American
industry. The produce industry, whether in the United States, Canada or
Mexico operates in an integrated manner. Our products share supply
chains and distribution points and there is substantial cross ownership
of production by multiple entities across national lines. As you are
aware, for example, California-based produce companies in many
instances have growing operations in California and in Mexico as well.
With the increasing difficulty obtaining agriculture laborers in the
United States, the trend on the part of U.S. companies to expand across
the border to Mexico will only continue. Another driver in this
integration is the globalization of supply as mandated by the larger
retailer purchasers. These large purchasers demand high quality,
reliable and safe product all year round. During the winter months,
Mexican fresh produce accounts for as much as 25 percent of U.S.
produce consumption. More than 4 billion pounds of produce enters the
U.S. at Nogales, Arizona to meet the U.S. consumer demand for year-
round, high-quality fresh produce. Evidence of this approach and
integration of the industry was clear in the course of the recent
investigation of Salmonella Saintpaul in tomatoes where it was found
that many distributors sourced from U.S., Canada and Mexico at the same
time.
For food safety, this globalization of the market and the advent of
large purchasers means that more and more all producers are being held
to one food safety standard--the standard set by the purchaser. As any
large retail outlet can validate, products are all held to the same
food safety standard regardless of the source of the product. For a
retailer, their brand and reputation is at issue. The purchaser will
remember where they purchased the product and not where the product was
produced. As a result, when there is a food safety incident, consumers
will stop purchasing the product regardless of the source. We have
learned this in the two biggest recent outbreaks: spinach from
California and now peppers from Mexico. We have learned that consumers
stop eating the product broadly--regardless of source. When there is a
food safety issue, the entire product category suffers a reduction in
sales and severe economic loss.
Another lesson that we have learned from recent outbreaks is that
while we ``are only as strong as our weakest link'' when it comes to
food safety that at the same time it is not always the small producer
that is the weakest link. In the case of spinach the failure did not
occur within a small operation; whereas for peppers this appears to be
the case. What we know is that is regardless of geographic region or
size of an entity that food safety failures can occur. It is common
sense backed up by science that risk cannot be reduced to zero. This
points to a fundamental principal that should be adopted in regulating
food safety: the cause of an outbreak is the failure in the system of
one specific entity--and not a failure of a geographic region or
particular type of entity. There should not be pre-conceived biases
against particular products, particular size of entity or particular
geographic region. The only focus should be to quickly track, based on
the facts at hand, to a specific entity in order to pinpoint and close
out that source.
In food safety, speed of an investigation is absolutely critical.
Once there has been an outbreak, the priority must be finding the
source of the contamination immediately. Undoubtedly, traceback is one
(but not the only) critical element of the investigation. From the
importer perspective, we would like to note that in the recent tomato
and chili pepper investigations, traceback did work across the border
into Mexico. There was no blackout of information or end of the trail
at the border with Mexico. Tomatoes and peppers were traced from
consumer to farm in both instances. This is a very important point
because some have suggested that whenever there is an outbreak that the
borders should be shut down, as if there is something different about
traceback at the border. But this is not the case, as shown in the
tomato and chili peppers investigations the traceback across the border
occurred successfully and with no slow up. Under the Bioterrorism Act,
foreign entities are required to register with the Department of Health
and Human Services, Food and Drug Administration and are required to
keep records one step up and one step back just as domestic entities.
Further, with all due respect, in response to the misguided
suggestion, by several at the hearing, that a response to an outbreak
should be closing of U.S. borders to imports, we would like to point
out that with regard to produce, imported products have not accounted
disproportionately for outbreaks. While including imports in the
solution is essential, it would not be sensible to target or single out
imports as the problem for a different approach. The approach should be
to continue to harmonize and standardize requirements so that all
producers are subject to the same standards and requirements.
A further point on standardization of requirements in the produce
sector is that U.S. produce is not more highly regulated than Mexican
or Canadian produce at the Federal level at this time. Good
Agricultural Practices for produce in the U.S. are not mandatory.
Therefore, making such requirements mandatory on imports would be
holding imports to a higher standard than domestic products and there
is no scientific justification for a difference in treatment. Any such
effort to hold imports to a higher standard than domestic products
would be a violation of U.S. international obligations under the WTO.
In the past, mandatory GAPs for imports only has been made and been
vetoed when reviewed by the United States Trade Representatives legal
counsel. It is a very important principle of international trade
agreements that domestic and imported products be regulated in an
equivalent manner so as to prevent an illegal trade barrier. The U.S.
subscribes to these international agreements so that U.S. products
(including U.S. produce exported to Mexico, for example) will not be
subject to trade barriers going into Mexico.
Another clarification to make clear is that FDA does have extensive
authority to regulate imports of produce and to stop imports on a
company-specific basis. Under its system of Detention Without Physical
Examination and Import Alerts, the FDA has the authority (which it
regularly and frequently uses) to prevent imports of a specific
shipment, product, region or exporter. DWPE is based on past history or
other information indicating the product may be a hazard. A product may
then be subject to a detention until the shipper or importer proves
that the product meets FDA standards. See http://www.foodsafety.gov/
8lrd/imp-info.html In other words, the system for stopping even
suspicious products at the border is well-established. FDA, in effect,
does have ``mandatory recall'' with regard to imports. Based on some of
the testimony and Member questions at the hearing, we are concerned
that the Members of Congress were not properly informed on how food
safety is enforced with regard to imports. We would be pleased to meet
with, answer questions and brief any Member or staff interested in
understanding this issue and how it operates at the border from an
operational perspective.
Whenever the issue of food safety is addressed, it is stated that
``we cannot sample/inspect our way out of this problem'' and we would
like to agree with and explain this view. First, this reality applies
equally to domestic production and to imports. It is not a theoretical
statement but rather a statement of fact. The volume of produce
consumed in the U.S. compared to the level of contamination is so small
that it is just not possible to always identify a 100 percent of the
contaminations through inspections. When there is an outbreak, FDA does
not begin testing every piece of produce in the U.S. because this would
be impossible. Instead, FDA initiates a traceback, a process of
pinpointing where to test in order to increase the odds of finding the
contamination. Unfortunately, in hearings on food safety, we do not
seem to be able to move beyond this red herring quickly, and important
time is often wasted reviewing again this point.
It is because 100% testing and inspection (not based on any
targeting or risk response) is not the answer, that the industry
recommends preventative measures such as preventative controls (food
safety workplans) that are verifiable. As you have heard in every
recent hearing on food safety, the majority of the produce industry
already has verifiable food safety plans in place. Many of these are
based on established and scaleable practices that are verified by third
parties. Some of these standards established by industry groups with
wide input and are published by FDA on its website. These are adhered
to by almost all producers of the covered products. With regard to
imports, we would suggest the idea of ``pushing the border back'' which
means that the focus should not be increased inspection at the border
but rather preventative and verifiable controls on the farms.
Following are some specific suggestions to FDA for improvement with
regard to imports:
(1) Sampling time must be shortened
The lengthy delays in sampling by FDA are another unintended source
of potential food safety problems for imports. In those situations
where FDA decides to sample and analyze fresh produce, it currently
takes as long as 72 to 96 hours to obtain the analytical results and a
release from FDA. Nearly 24 hours of that delay is consumed by the
sampling and shipping process alone--delivering the sample to the FDA
laboratory. However, another 18 hours of delay occurs when FDA
laboratory analysts, with flexi-time schedules, arrive for work in the
lab at 6:00 a.m., and leave by 2:00 p.m. When a sample of fresh product
arrives at the laboratory for analysis at 11:00 a.m. or noon (or
later), the analyst will wait until the next day to set up and run the
sample. This additional delay compounds the damage to produce caused by
increased time and less-than-optimum storage conditions. In too many
cases, by the time clean laboratory results are received and reported,
the fresh produce has already passed a quality point requiring it to be
discarded. In this regard, FDA's testing processes, which are intended
to ensure that an imported shipment is safe, ironically contributes
substantially to the tested food being of such a lower level of quality
that it is no longer marketable--and yet FDA releases the shipment
because of the clean analytical results.
(2) Regulations and requirements must be updated through a
transparent process
FPAA deals at the border with a range of U.S. regulating agencies,
including CBP and FDA. It is our experience that FDA appears to be
under-funded and not in control of its border function resulting in
arbitrary, unpredictable and non-uniform practices. This encourages
exporters and importers to engage in ``forum shopping'' among ports and
weak links in the food safety activities at the border. In our
experience FDA is somewhat a ``black box.'' The FDA has historically
operated its import operations on the back of antiquated agency
policies and procedures, which were created in the 1970s. Chapter 9 of
FDA's Regulatory Procedures Manual, a few regulations promulgated in
the last century, and the more recent Bioterrorism Act regulations
(relating to prior notice of imported foods and registration of food
facilities) together represent the total sum of FDA policies and
procedures for managing as much as half of all of FDA's regulated
commodities in interstate commerce. FDA operates according to many
unpublished internal procedures, and some districts have promulgated
local policies and procedures to address certain isolated problems in
the importation process. However, the vast majority if FDA policies and
requirements are not published. Therefore Many of FDA's published
procedures (the RPM, the Investigation Operations Manual, Compliance
Policy Guides and Compliance Program Manual Guides) have no legal
effect whatsoever; however, they are implemented as if they are
regulations promulgated under the Food Drug and Cosmetic Act.
These and other incongruities could be resolved if FDA would
operate with a level of transparency similar to Customs and Border
Protection. Customs' local port offices also issue local procedures,
but they do so after entering into open and public dialogue with the
affected industry. FPAA recommends FDA enter into a public dialogue
with the fresh produce industry to revise its procedures and policies
relevant to the agency's import operations.
(3) Recognition of point of origin testing
Many Mexican fresh produce growers and packers already conduct
routine tests of product prior to shipment. FPAA urges that FDA begin
recognizing and incorporating into its own import risk screening
process the routine, scientifically sound, and reliable laboratory
testing being conducted at the point of origin. FPAA believes this will
assist the Agency in focusing its limited import inspection resources
on those shipments that have not been tested or that pose some
additional and identifiable risk factor. Many Mexican growers also
implement routine and rigorous water analyses and Good Agricultural
Practices to ensure their products are safe for consumption. Although
each of these components should eventually be considered in developing
a dynamic risk-based imported food safety program, point of origin
sampling and analysis--whether the analysis is conducted in Mexico or
in the U.S.--can quickly be incorporated into FDA's current decision
making process when product arrives at the port of entry.
(4) FDA should work to develop a program for small entities
Finally, we would like to agree that the additional food safety
requirements will be hard for small companies, whether they are
entities located in the United States or in Mexico. The expense of
developing a food safety plan that is certified by third parties is
significant. We must all work together to make sure that the small
growers and importers are treated fairly and perhaps subsidized in some
way with regard to the expense of certification and compliance.
* * * * *
We appreciate all of your effort on behalf of the produce industry
and we look forward to working with you in the months and years ahead.
Sincerely,
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