<DOC>
[105 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:50357.wais]
S. Hrg. 105-516
Part II
THE SAFETY OF FOOD IMPORTS: FROM THE FARM TO THE TABLE--A CASE STUDY OF
TAINTED IMPORTED FRUIT
=======================================================================
HEARING
before the
PERMANENT
SUBCOMMITTEE ON INVESTIGATIONS
of the
COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
__________
PART II
__________
JULY 9, 1998
Printed for the use of the Committee on Governmental Affairs
-----------
U.S. GOVERNMENT PRINTING OFFICE
50-357 CC WASHINGTON : 1998
_______________________________________________________________________
For sale by the Superintendent of Documents, Congressional Sales Office
U.S. Government Printing Office, Washington, DC 20402
COMMITTEE ON GOVERNMENTAL AFFAIRS
FRED THOMPSON, Tennessee, Chairman
WILLIAM V. ROTH, Jr., Delaware JOHN GLENN, Ohio
TED STEVENS, Alaska CARL LEVIN, Michigan
SUSAN M. COLLINS, Maine JOSEPH I. LIEBERMAN, Connecticut
SAM BROWNBACK, Kansas DANIEL K. AKAKA, Hawaii
PETE V. DOMENICI, New Mexico RICHARD J. DURBIN, Illinois
THAD COCHRAN, Mississippi ROBERT G. TORRICELLI,
DON NICKLES, Oklahoma New Jersey
ARLEN SPECTER, Pennsylvania MAX CLELAND, Georgia
Hannah S. Sistare, Staff Director and Counsel
Leonard Weiss, Minority Staff Director
Lynn L. Baker, Chief Clerk
------
PERMANENT SUBCOMMITTEE ON INVESTIGATIONS
SUSAN M. COLLINS, Maine, Chairman
WILLIAM V. ROTH, Jr., Delaware JOHN GLENN, Ohio
TED STEVENS, Alaska CARL LEVIN, Michigan
SAM BROWNBACK, Kansas JOSEPH I. LIEBERMAN, Connecticut
PETE V. DOMENICI, New Mexico DANIEL K. AKAKA, Hawaii
THAD COCHRAN, Mississippi RICHARD J. DURBIN, Illinois
DON NICKLES, Oklahoma ROBERT G. TORRICELLI, New Jersey
ARLEN SPECTER, Pennsylvania MAX CLELAND, Georgia
Timothy J. Shea, Chief Counsel and Staff Director
David McKean, Minority Staff Director
Pamela Marple, Minority Chief Counsel
Mary D. Robertson, Chief Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Collins.............................................. 1
Senator Levin................................................ 3
Senator Cochran.............................................. 5
Senator Lieberman............................................ 6
Prepared statement:
Senator Cleland.............................................. 43
WITNESSES
Thursday, July 8, 1998
Dr. Stephanie A. Smith, Investigator, Permanent Subcommittee on
Investigations, Committee on Governmental Affairs, U.S. Senate. 9
Dr. Jeffery A. Foran, Cyclospora Case Patient, and Executive
Director, Risk Science Institute, International Life Science
Institute...................................................... 13
Dr. Stephen M. Ostroff, Associate Director for Epidemiologic
Science, National Center for Infectious Diseases, Centers for
Disease Control and Prevention, Atlanta, Georgia, accompanied
by Dr. Barbara L. Herwaldt, Medical Epidemiologist, Division of
Parasitic Diseases............................................. 16
Alphabetical List of Witnesses
Foran, Dr. Jeffery A.:
Testimony.................................................... 13
Prepared Statement........................................... 161
Ostroff, Dr. Stephen M.:
Testimony.................................................... 16
Prepared Statement........................................... 165
Smith, Dr. Stephanie A.:
Testimony.................................................... 9
APPENDIX
Exhibit List for July 9, 1998 Hearing
* May be found in the files of the Subcommittee.
Page
1. Chart prepared by the Permanent Subcommittee on
Investigations, ``1996 and 1997 Cyclosporiasis Outbreaks, Areas
Affected In The U.S.''......................................... 44
2. Chart and photographs prepared by the Permanent Subcommittee
on Investigations in conjunction with statement by Dr.
Stephanie A. Smith--Flow Chart ``Fresh Raspberries From Farm to
Table'' and photographs of Guatemalan Raspberry Farm
(Photograph 1-3), Sorting Table (Photograph 4), Sorting and
Classifying (Photograph 5), Raspberry Flats (Photograph 6), and
Port of Entry (Photograph 7)................................... 45
3. Publications submitted by Centers for Disease Control and
Prevention:
a. FoodNet, CDC/USDA/FDA Foodborne Diseases Active
Surveillance Network, CDC's Emerging Infections Program,
1997 Surveillance Results.................................. *
b. Addressing Emerging Infectious Disease Threats, A
Prevention for the United States, 1994..................... *
4. SEM Surface Structure of Raspberry and Blackberry, 1mm and
100mm.......................................................... 53
5. Charts prepared by the Centers for Disease Control and
Prevention:
a. The National Molecular Subtyping Network for Foodborne
Disease Surveillance....................................... 55
b. Burden of Foodborne Diseases............................. 56
6. Statement for the Record, Guatemalan High Level Commission
for Food Safety: Berry Production in Guatemala................. 57
7. Pamphlet, ``Guatemalan Berries, Spring-Summer 1998''
prepared by the Guatemalan Berry Commission.................... 62
8. Memoranda prepared by Don Mullinax, Chief Investigator,
Stephanie Smith, PhD, Investigator, and Mary Mitschow, Counsel,
Permanent Subcommittee on Investigations, dated July 6, 1998,
to Permanent Subcommittee on Investigations' Membership
Liaisons, regarding ``PSI Hearing On The Safety of Food
Imports: From The Farm to The Table--A Case Study of Tainted
Imported Fruit''............................................... 70
9. Supplemental Questions and Answers for the Record, Dr.
Stephan M. Ostroff, Centers for Disease Control and Prevention. 150
10. Supplemental Questions and Answers for the Record, Dr.
Jeffery Foran, Executive Director, Risk Science Institute,
International Life Science Institute........................... 152
11. Supplemental Questions and Answers for the Record, Dr.
Stephanie A. Smith, Investigator, Permanent Subcommittee on
Investigations................................................. 154
12. Comments for the Record, Fresh Produce Association of the
Americas....................................................... 156
THE SAFETY OF FOOD IMPORTS: FROM THE FARM TO THE TABLE--A CASE STUDY OF
TAINTED IMPORTED FRUIT--PART II
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THURSDAY, JULY 9, 1998
U.S. Senate,
Permanent Subcommittee on Investigations,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 9:31 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Susan M.
Collins, Chairman of the Subcommittee, presiding.
Present: Senators Collins, Cochran, Levin, Lieberman, and
Durbin.
Staff Present: Timothy J. Shea, Majority Chief Counsel and
Staff Director; Mary D. Robertson, Chief Clerk; Don Mullinax,
Chief Investigator; Eric Eskew, Investigator (Detailee, HHS-
IG); Lindsey E. Ledwin, Staff Assistant; Kirk E. Walder,
Investigator; Dr. Stephanie A. Smith, Investigator
(Congressional Fellow); Beth Stein, Counsel to the Minority;
Brian Benczkowski (Senator Domenici); Butch Burke (Senator
Stevens); Pam Muha (Senator Specter); Michael Loesch (Senator
Cochran); Maggie Hickey (Senator Thompson); Felicia Knight and
Steve Abbott (Senator Collins); Kevin Mulry and Marianne Upton
(Senator Durbin); Antigone Potamianus (Senator Levin); Doug
O'Malley and Kevin Landy (Senator Lieberman); and Lynn Kimmerly
and Donna Berry (Senator Cleland).
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Good morning. The Subcommittee will please
come to order.
Today the Permanent Subcommittee on Investigations holds
its second in a series of hearings on the safety of imported
food. Food safety is a serious and growing public health
concern. The escalation in the number of foodborne illnesses at
a time when food imports are soaring prompted the Subcommittee
to focus its investigation on the safety of imported fruit and
vegetables.
At the Subcommittee's first hearing in May, the General
Accounting Office reported that as many as 81 million cases of
foodborne illnesses and more than 9,000 related deaths are
estimated to occur in the United States each year. The medical
treatment and lost productivity resulting from foodborne
illnesses costs billions of dollars a year.
We also learned that the system intended to protect
Americans from tainted imported food is not effective. The
General Accounting Office told the Subcommittee that ``Federal
agencies cannot ensure that the growing volume of imported food
is safe for consumers.'' Specifically, the GAO reported that
agencies have not targeted their resources on imported foods
posing the greatest risks and concluded that the limited
resources available to the Food and Drug Administration and the
U.S. Department of Agriculture must be more efficiently
deployed to better protect Americans from unsafe imported food.
In its report to the Subcommittee, the GAO also found that
``weaknesses in controls over food imports enable entry of
unsafe products.'' In other words, even if Federal inspectors
discover tainted food, controls are not in place to prevent
unsafe products from entering the marketplace and ending up on
the dinner tables of America.
For example, during one U.S. Customs Service special
operation, 70 percent of the food shipments that the FDA had
ordered destroyed or re-exported because they were unsafe
actually entered into the American marketplace.
As a continuation of the Subcommittee's investigation into
the safety of imported food, our hearing today will examine a
case study of tainted imported fruit. We will look at the food
import system from the farm to the table and hear how a
microscope organism made thousands of Americans sick in 1996
and 1997 from eating tainted raspberries.
In the spring of 1996 and 1997, as the chart before you
shows,\1\ people from Maine to California, in a total of 23
States and the District of Columbia, became sick. They
experienced symptoms of foodborne illness. Many of these
victims ate food at common events. This common link led public
health officials to mobilize resources in an effort to
determine the case of these illnesses.
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\1\ See Exhibit No. 1 which appears in the Appendix on page 44.
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We know the probable source of the 1996 and 1997 outbreaks
because of the scientific traceback investigation conducted by
public health officials, Federal regulatory agencies, and the
Centers for Disease Control and Prevention. It is this
fascinating and painstaking process--the traceback of a
foodborne illness from the patient back to the source of
contamination--that we will examine in the hearing this
morning.
The Subcommittee's inquiry will focus on the following
critical questions: How is fresh fruit produced and then
imported into the United States? What are the ways in which
produce can become contaminated? And how do the CDC and other
public health agencies investigate outbreaks of foodborne
illnesses to determine the source of contamination?
To assist the Subcommittee, we are fortunate to have a
distinguished group of scientists here this morning. First, we
will hear from Dr. Stephanie Smith. Dr. Smith is a food
scientist by training and is currently working with the
Subcommittee on a 1-year fellowship. As a Subcommittee
investigator, she traveled to Guatemala to observe first-hand
the production and exportation process for raspberries.
Second, we are pleased to have Dr. Jeffery Foran, an
environmental scientist who himself became ill in 1996 after
eating raspberries from Guatemala.
Finally, we will hear from CDC officials. Dr. Stephen
Ostroff is an Associate Director at CDC's National Center for
Infectious Diseases. Dr. Barbara Herwaldt is a CDC medical
epidemiologist who led the Division of Parasitic Diseases team
which investigated the 1996 Cyclospora outbreak. The CDC is the
Federal agency to which many public health officials turn for
scientific expertise when outbreaks of foodborne illnesses
occur.
Let me also mention that I invited the Guatemalan
Ambassador to the United States to submit a written statement
describing improvements made to the Guatemalan production and
expert process since the 1996 and 1997 Cyclospora outbreaks.
This week, we received through the Guatemalan Embassy a written
statement from the Guatemalan High Level Commission for Food
Safety. This statement will be made a part of today's hearing
record.\1\
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\1\ See Exhibit No. 6 which appears in the Appendix on page 57.
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I want to emphasize that this hearing is not intended to
single out Guatemala. As the Guatemalan officials have
indicated, considerable improvements have been made in that
country's production process, and in fact it was Guatemala
which voluntarily suspended the export of raspberries in 1997
after that fruit was identified as the cause of the Cyclospora
outbreak. The Subcommittee's purpose is not to indict one
country or region of the world but rather to focus on a case
study of tainted imported fruit from the farm in a foreign
country to the tables of America, in order to understand how we
can better protect the American consumer.
The safety of food imports is literally a life and death
issue for many people, especially our children and our elderly.
As the vast majority of our food supply is safe, consumers
should not stop eating imported fruit and vegetables. However,
this country's food safety net must be improved so that
consumers are protected from the risk of unsafe foods,
particularly when contamination is not detectable by the
average consumer.
The difficulty of this task is demonstrated by the fact
that just 3 weeks ago, press reports described yet another
serious outbreak of Cyclospora, this time in Canada, which may
also prove to be caused by raspberries imported from Central
America.
As we continue this important work, we are looking forward
to hearing from our witnesses this morning in order to learn
more about foodborne illnesses, how they occur, and how they
can be prevented.
It is now my pleasure to recognize Senator Levin for any
statement he may have.
OPENING STATEMENT OF SENATOR LEVIN
Senator Levin. Madam Chair, thank you, and thank you for
holding this series of hearings. Your leadership is critically
important. We all appreciate it, and the Nation is better off
because of it.
Ensuring the safety of the Nation's food supply, both
domestic and imported, should be a top priority for Congress.
Americans are eating more and more imported food, especially
imported produce. A recent GAO report noted that in 1980, 24
percent of the fruit consumed by Americans was imported and
that by 1995, that number had increased by more than a third,
to 33 percent. The same report shows that the percentage of
vegetables imported had increased from 7 percent to 11 percent.
The fundamental importance of ensuring food safety was
highlighted once again when an outbreak of hepatitis A in my
home State of Michigan occurred last year. Hundreds of Michigan
schoolchildren were sickened from eating tainted frozen
strawberries imported from Mexico that had improperly and
illegally found their way into the school lunch program.
Those who are least able to protect themselves, as our
Chairman said, including women, children, and people with
weakened immune systems, are the most vulnerable to foodborne
illnesses.
I am happy that we recently passed S. 1150, a bill which
included a number of important food safety elements that are
similar to elements contained in companion bill which
Representative Debbie Stabenow and I had previously introduced,
including a provision that requires the Department of
Agriculture to form a FEMA-like crisis management team to
handle food poisoning outbreaks and other agriculture-related
emergencies. These crisis management teams will integrate
efforts with Federal, State and local agencies as well as with
our colleges and universities and other research organizations
and function quickly to limit the harmful effects of
contaminated food.
As the volume of imported food, especially fruit and
vegetables, continues to increase significantly while our
Federal Government inspection resources remain the same, it is
not surprising that the percentage of imported food shipments
actually inspected has decreased. In other words, the FDA
cannot keep pace with the increasing volumes of imported foods
under its jurisdiction, namely, fruit, vegetables and grains.
In 1992, the FDA inspected 8 percent of imported foods. In
1997, it was only able to inspect 2 percent of imported foods.
So we are going in the wrong direction.
At the first hearing on this subject, we learned that
Federal inspection of imported foods is woefully inadequate.
Enforcement is understaffed; remedies for violation of the food
safety laws are weak. The President, as part of his Food Safety
Initiative, has proposed that we provide the FDA with authority
to require that imported foods be produced in foreign countries
under food safety systems that are equivalent to those in the
United States. He has also proposed increasing funding to
enhance inspections by FDA personnel. I hope we will act on
those measures promptly, hopefully in this Congress.
We must also strengthen legal remedies available to Federal
inspectors by providing the Department of Agriculture with
authority to mandate recalls of food under their jurisdiction
and to increase fines that they can levy for food safety
related violations.
The President has also asked Federal agencies to devise a
plan for creating a National Institute for Food Safety Research
and has directed the FDA to issue regulations that would
require warning labels on fruit juice that has not been
pasteurized or otherwise processed to kill bacteria.
The case study that the Subcommittee takes up today, like
the issue of tainted frozen strawberries from Mexico that
sickened children in Michigan, reflects great gaps and
weaknesses in our Federal food safety scheme. We should provide
the FDA equivalency authority. We should empower regulators to
mandate recalls of tainted food. We should strengthen penalties
for violating food safety laws, and hopefully, we should act in
this Congress before more Americans are stricken by foodborne
illnesses that could have been prevented had those fruit and
vegetables been grown in the United States.
I want to again thank you, Madam Chairman, and thank our
witnesses for their appearance today. I have to be at the Armed
Services Committee as the senior Democrat there on an important
hearing, so I will not be able to be here for this testimony,
but I will surely follow it closely.
Senator Collins. Thank you, Senator Levin.
It is now my pleasure to recognize Senator Cochran, who is
the Chairman of the Agriculture Appropriations Subcommittee,
for any statement that he might have.
OPENING STATEMENT OF SENATOR COCHRAN
Senator Cochran. Thank you very much, Madam Chairman.
Let me first commend you for this series of hearings you
are having and the investigation that is being conducted by
this Permanent Subcommittee on Investigations. I am happy to be
a Member of this Subcommittee, and I think it can be a very
helpful and important contribution to our understanding more
fully the problems of food safety in terms of inspection and
detection. More complicated, and perhaps more important than
any of this, is the question of which options we select to make
a part of a reform effort to ensure that we do all that we
possibly can to protect the safety and health of the consumers
in America. That is the big challenge as I see it, and I hope
that as we go through the process of looking at the facts that
have been compiled by the Centers for Disease Control and other
agencies and researchers, that we keep in mind that at some
point, we have to confront the real challenge of coming up with
a better system.
Obviously, efficiencies have to be introduced into our food
safety and inspection system at the Department of Agriculture
and at the Food and Drug Administration. Just giving the power
to fine, the power to ban, to specific Federal agencies is not
enough. We have disagreements now between those agencies as to
which would be the more appropriate agency to have what
authority, we have to cut through all of this internecine
competition within the Federal agencies. We also have to
confront the realities of possible retaliation from countries
where bans may be imposed unilaterally, without any due process
requirement, by a Federal agency. There are all kinds of
problems that we have to understand before we make final
decisions about how to improve the system that we have.
We need to work hard, and I think the conduct of this
hearing shows how concerned this Congress is to get something
done that makes sense, that is workable, that is affordable,
and that serves the overriding interests of the consumers and
the public in this country of ours.
We have the safest supply of food of any country in the
world, and we have an enormous opportunity to import, because
of our high standard of living, food from all over the world,
and our consumers have a greater range and variety of fresh
vegetables and produce and wholesome meat and poultry and
seafood of any country in the world, and of this, we are very
proud.
But we do have some serious problems, and they will be
identified, and that is the purpose of this hearing, to find
out the extent of the problems that we have now in terms of
detecting contaminated food supplies, particularly from
imported fruit and vegetables. Ensuring the safety of those
foodstuffs comes under the jurisdiction of the Food and Drug
Administration.
I am very glad to be here today, and I look forward to
hearing the testimony and working closely with the other
Members of this Committee to try to help come up with the best
possible solution for dealing with the problems that we have.
Thank you.
Senator Collins. Thank you very much, Senator Cochran.
Senator Lieberman, it is a pleasure to have you here today
as well.
OPENING STATEMENT OF SENATOR LIEBERMAN
Senator Lieberman. Thank you, Madam Chairman, and thanks
for conducting this very important series of hearings examining
the safety of the food we eat. Thanks also to your staff for
the high level of work that they have done on this.
In my first year in the Senate, 1989, I was involved in an
investigation that the Environment and Public Works Committee
did on pesticides in our foods. One of the things we found was
that the FDA was letting into the country products that had
been sprayed with pesticides that were illegal here. Another
thing we found was that some American growers were using
illegal pesticides on crops being grown for export.
Both of those practices were outrageous and unacceptable,
and in time, Congress and the Executive Branch did something
about it.
The problem of the safety of the food we eat, particularly
the food that is imported, has become much worse since that
first series of hearings I participated in in 1989 as it
relates to imports, because, as we have indicated, the
percentage of food that we eat that is imported has multiplied
dramatically.
Let me read from a quote given to The New York Times by Dr.
Robert Tauxe, Chief of the Foodborne and Diarrheal Disease
Branch at the Centers for Disease Control. He said: ``Go to a
restaurant and take a look at your supper. How many different
continents are on your plate?'' We could say that for a lot of
the meals we eat at home as well.
``The food chain that fills those plates has become
unimaginably intricate,'' and they cite as an example alfalfa
sprouts, which gave salmonella to hundreds of people in 24
States in the last couple of years. The seeds for those sprouts
were bought from Uganda and Pakistan, among other nations, they
were shipped through the Netherlands, they were flown into New
York, and they were trucked around the United States. That is
why previously unknown pathogens are being discovered
repeatedly and years after they arrive in the United States. It
is one of the down sides of the global economy from which we
have benefited in so many other ways.
So I think this series of hearing is critically important.
I remember at the end of that series of hearings in 1989 saying
that the party that you register with or the ideology that you
hold does not affect the level of your concern about the safety
of what you eat. I think that remains true. If there is
anything that the public wants us to do, it is to act in areas
like this, where they simply cannot act to protect themselves.
We are a long way from the days when people used to grow most
of the fruit and vegetables they ate right around where they
lived. They come from all over the country, and now, from all
over the world, and they need us to stand as best we can
between them, their stomachs and the rest of the world that
puts food on their table.
So I think there is a very broad public consensus that we
do something about this. I particularly appreciate today, Madam
Chair, that you are going to examine a case study, the
cyclosporiasis outbreak, because I think it can help us bring
into relief those things that the government is doing well
along with the private sector and those things were are not
doing well and, in some cases, are doing very badly.
I was quite impressed in reviewing the materials for this
morning's hearing, this instance, by the excellent response of
the CDC and our other public health officials to this fast-
developing public health crisis. I know we are going to hear
today about how they quickly traced seemingly isolated cases of
a rare illness to a handful of raspberry farms in Guatemala.
It is a modern-day international epidemiological--and I
might even add, gastrointestinal--Sherlock Holmes story. There
is probably a movie here somewhere. But it is remarkable and
quite impressive, and clearly one of the things that we do well
to the benefit of all in our country. And in the case of the
cyclosporiasis crisis, which affected about 40 people in the
State of Connecticut, I want to offer my thanks to the CDC for
what they did.
But among the things that we do not yet do well, as has
been testified to, is to find a way to raise the level of
protection of the food that we are importing. As I age, my
memory may be somewhat faulty, but I remember a witness, I
believe from the FDA--we were talking about how much inspection
occurred of imported fruit--and he was referring to a shipment
of bananas that had some problems with pesticides, and he
referenced ``two'' inspections.
So I asked, ``Of boatloads of bananas?''
``No.''
``Of two boxes of bananas?''
``No.''
I asked, ``Two what?''
He said, ``Two bananas.''
Well, I may have the details of the story slightly off, but
that is how poor it was then, and it is poorer now. As Senator
Levin indicated, only 2 percent of imported foods are inspected
by FDA.
So we continue to have what I would describe as a desperate
need to give more authority to the FDA over imported fruit and
vegetables and more people to exercise that authority, and I
hope that some support for that emerges from these very
important hearings that you are holding, Madam Chair.
I thank you for your leadership here, and I look forward to
working with you and hearing the witnesses today.
Senator Collins. Thank you, Senator.
Due to time constraints, the Subcommittee was unable to
accommodate everyone who wished to testify today. We will,
however, be leaving the hearing record open for 10 days so that
anyone who wishes to submit a written statement may do so.
In addition, without objection and for the convenience of
all the Members, all exhibits, including the photographs and
charts previously made available to Subcommittee Members, will
be made part of the hearing record.
I would now like to ask our panel of witnesses to come
forward. Our witnesses this morning will describe for us how
outbreaks of foodborne illnesses are investigated and
specifically examine the 1996 and 1997 outbreaks of Cyclospora
associated with Guatemalan raspberries.
The first witness, Dr. Stephanie Smith, is currently an
investigator who is on the temporary staff of the Permanent
Subcommittee on Investigations. Dr. Smith has a doctorate in
food science from Michigan State University and nearly 6 years
of food industry experience with two international companies as
well as a domestic food distributor. She has been working as an
investigator for the Subcommittee since October 1997, and we
have been very pleased to have her as part of our team.
As part of the Subcommittee's investigation, Dr. Smith
traveled to Guatemala to observe first-hand the raspberry
production and exportation process.
Our second witness, Dr. Jeffery Foran, is an environmental
scientist and expert in quantitative risk assessment. Dr. Foran
is the Executive Director of the Risk Science Institute in
Washington, DC. The Risk Science Institute is a component of
the International Life Science Institute, a nonprofit,
worldwide foundation established in 1978 to advance the
understanding of scientific issues related to nutrition, food
safety, toxicology, risk assessment and environment. In
addition to being a scientist, Dr. Foran was also a consumer
who became ill after consuming Guatemalan raspberries, proving
that no matter what your level of expertise, no one is immune
to Cyclospora.
Finally, we will hear from two officials from the CDC, Dr.
Stephen Ostroff and Dr. Barbara Herwaldt, who are both with
CDC's National Center for Infectious Diseases. Dr. Ostroff is
the Associate Director for Epidemiologic Science, and Dr.
Herwaldt is a medical epidemiologist in the Division of
Parasitic Diseases. Both have extensive experience in
investigating and tracking infectious diseases and were
involved in the Cyclospora case that we are examining today.
Pursuant to Rule 6, all witnesses who testify before the
Subcommittee are required to be sworn in, and you have already
stood for me, but please raise your right hands.
Do you swear that the testimony you are about to give to
the Subcommittee will be the truth, the whole truth, and
nothing but the truth, so help you, God?
Dr. Ostroff. I do.
Dr. Herwaldt. I do.
Dr. Smith. I do.
Dr. Foran. I do.
Senator Collins. Thank you. Please be seated.
I am going to ask each of you, in the interest of time, to
limit your oral testimony to about 10 minutes each. If you need
a little longer, that is fine as well. We will be using a
timing system this morning to assist you. Before the red light
comes on, you will see the lights change from green to orange,
and that will tell you that you have 1 minute left to wrap up
your testimony. I want to assure you that your entire prepared
testimony will be included in the record in its entirety.
Dr. Smith, please proceed, and again, thank you for all
your assistance to the Subcommittee.
TESTIMONY OF DR. STEPHANIE A. SMITH, INVESTIGATOR, PERMANENT
SUBCOMMITTEE ON INVESTIGATIONS, COMMITTEE ON GOVERNMENTAL
AFFAIRS, U.S. SENATE
Dr. Smith. I would like to thank Senator Collins for the
opportunity to testify today before the Permanent Subcommittee
on Investigations. I have a doctorate in food science from
Michigan State University and nearly 6 years of food industry
experience, as the Senator mentioned. I have been working as an
investigator on the Permanent Subcommittee on Investigations
since October of last year.
This morning, I will report to the Subcommittee the results
of a case study which is part of the ongoing investigation
conducted at the direction of Senator Collins. I will describe
the process by which fruit grown abroad reaches American
consumers, using raspberry production in Guatemala as an
example.
Fresh Guatemalan raspberries have received considerable
attention because of their association with outbreaks of an
infection caused by Cyclospora cayetanensis, which occurred in
the United States and Canada during the spring of 1996 and
spring of 1997. Cyclospora is a protozoan parasite that causes
a gastrointestinal illness called cyclosporiasis. This illness
is typically characterized by watery diarrhea and other
symptoms such as nausea, abdominal cramps, substantial weight
loss and fatigue. If not treated, the illness can be severe and
prolonged.
Prior to the 1996 outbreak, Cyclospora was relatively
unknown in the United States. According to the scientific
literature, only sporadic cases, mostly in travelers, and two
small clusters of cyclosporiasis were recognized in North
America. These clusters were associated with water, not food.
I would like to make two points. First, very strong
epidemiological evidence implicates the source of
cyclosporiasis outbreaks of spring 1996 and spring 1997 as
fresh Guatemalan raspberries. However, neither the source of
the contamination nor the point at which the contamination
occurred is clear. One hypothesis is that raspberries became
contaminated through spraying with insecticides and fungicides
mixed with contaminated water. Other hypotheses consider soil,
animals or humans as sources of the contamination on the farm.
Second, our investigation revealed that the Guatemalans,
working with the Centers for Disease Control and Prevention and
the Food and Drug Administration, have made considerable
investments to upgrade their farm facilities and train their
employees in proper agricultural, post-harvest handling,
sanitation, personal hygiene and recordkeeping practices.
In late March of this year, as part of the Subcommittee's
comprehensive investigation of the safety of food imports, I,
along with the Subcommittee's chief investigator, spent 4 days
in Guatemala. The purpose of our trip was threefold: (1) to
meet with representatives who were involved in production and
exportation of fresh raspberries; (2) to make first-hand
observations of raspberry farms and packing facilities; and (3)
to document the raspberry production process. Our trip included
visits to two analytical laboratories, 10 berry farms, and a
produce freezing facility.
My comments today will be based on our observations as well
as information supplied by the CDC, the FDA, the U.S.
Department of Agriculture, the U.S. Customs Service, and
officials of the Guatemalan Government.
I would now like to walk through the process of raspberry
production and distribution from a typical Guatemalan farm to
an American table. As I stated, the mode of contamination of
the fresh raspberries with Cyclospora remains unknown. However,
I will highlight points in the generalized process at which the
berries could have become contaminated. Keep in mind, that, in
general, anything that comes in direct contact with the fruit,
including water, soil and human hands, is potentially a source
of contamination. My testimony will follow the flow diagram
displayed here.\1\
---------------------------------------------------------------------------
\1\ See Exhibit No. 2 which appears in the Appendix on page 45.
---------------------------------------------------------------------------
For seedlings to become flowering plants requires
approximately 6 months. Another 6 weeks is required for
raspberries to be ready for harvest. This photograph \2\ shows
how raspberry plants are grown--typically, in hedgerows,
supported by posts and wires. The plants are approximately 4 to
5 feet high and may or may not be tied to the wires
individually, as shown here. The location of the fruit on the
plant is at least 3 feet off the ground, and therefore, no
direct contact occurs between the fruit and the soil. Soil is a
possible vehicle of contamination, therefore, it is important
that the soil not touch the fruit.
---------------------------------------------------------------------------
\2\ Photograph 1 of Exhibit No. 2 appears in the Appendix on page
46.
---------------------------------------------------------------------------
The plants are watered using drip irrigation. A drip
irrigation system typically consists of a piece of plastic
tubing running along the ground as shown in this photograph.
The underside of the tubing has small holes so the ground can
be wet slowly over a long period of time. Fertilizers, if used,
are administered through the drip irrigation system. No direct
contact occurs between the fruit and the irrigation water.
Pesticides are generally mixed with potable or drinking-
quality water and sprayed directly onto the plants or the soil
below. This is the only water other than rain that
intentionally contacts the berries directly.
The berries are harvested dry and not washed at any point
prior to sale, because they are very susceptible to mold. Water
is also a possible source of contamination. Therefore, the
quality of any water that contacts the berries is significant.
Raspberries are harvested by hand, primarily by women. The
berries must be handled very gently to preserve their quality.
Ripe berries can be pulled from the plant very easily. The
pickers generally carry plastic trays strapped around their
waists to keep their hands free, as shown in this
photograph.\1\ The plastic trays hold small plastic baskets
into which the berries are placed. Again, let me emphasize that
anything that comes in direct contact with the fruit, if
contaminated itself, is a possible source of contamination.
---------------------------------------------------------------------------
\1\ Photograph 2 of Exhibit No. 2 appears in the Appendix on page
47.
---------------------------------------------------------------------------
Once the baskets are full, the tray is taken to a packing
shelter such as the one shown in this photograph.\2\ Typically,
these structures have poured concrete floors and screened pass-
through windows. By passing the trays brought from the fields
through a window, tracking dirt from the field into the packing
shelter is avoided. Some farms also use foot baths just outside
the packing shelter door to clean shoe bottoms before entering.
---------------------------------------------------------------------------
\2\ Photograph 3 of Exhibit No. 2 appears in the Appendix on page
48.
---------------------------------------------------------------------------
Inside the packing shelter, berries are classified as
export grade or domestic grade based on color and degree of
ripeness. The berries are generally sorted and classified on
large tables with smooth white surfaces, under a covered
fluorescent light as shown in this photograph.\3\
---------------------------------------------------------------------------
\3\ Photograph 4 of Exhibit No. 2 appears in the Appendix on page
49.
---------------------------------------------------------------------------
The next photograph shows workers actually sorting,
classifying and packing raspberries selected for export as
fresh product in plastic containers called clamshells.\4\
Containers of this type are commonly used for raspberries and
blueberries. The clamshells are packed in cardboard flats, as
shown in this photograph.\5\
---------------------------------------------------------------------------
\4\ Photograph 5 of Exhibit No. 2 appears in the Appendix on page
50.
\5\ Photograph 6 of Exhibit No. 2 appears in the Appendix on page
51.
---------------------------------------------------------------------------
A flat holds 12 clamshells. The packaged fresh berries are
stored in refrigerated rooms on individual farms or are
transported within hours to exporter warehouses for cold
storage prior to export. Possible sources of contamination
during sorting and packing include dirty hands and tabletops.
For shipping, the cardboard flats are packed in 3'x3'x4'
styrofoam-insulated cardboard boxes referred to as E-
containers. One E-container holds 10 flats plus gelpacks added
to keep the berries cold. The E-containers are transported in
refrigerated trucks from exporter warehouses to the airport.
Generally, the trucks arrive at the airport between 11 p.m. and
midnight.
Upon arrival, the berries are held in cold storage in the
cargo area. Between 2 a.m. and 4 a.m., the berries are loaded
onto either a cargo or passenger plane. All fresh raspberries
from Guatemala are shipped by air to the United States.
Miami, Florida has been the principal port of entry for
fresh Guatemalan raspberries, with the majority of the berries
passing through its airport. After arriving in Miami, the
berries are unloaded from the planes, as shown in this
photograph. \1\ The berries must then be cleared by the USDA's
Animal and Plant Health Inspection Service, or APHIS.
---------------------------------------------------------------------------
\1\ Photograph 7 of Exhibit No. 2 appears in the Appendix on page
52.
---------------------------------------------------------------------------
The inspectors use USDA cargo clearance areas containing
examination tables for visual inspection of incoming plants and
plant products, including fruit and vegetables. The role of
APHIS is to protect U.S. animals and plants from the spread of
foreign animal and plant pests and diseases--not to protect
U.S. consumers from human disease.
For raspberries, the inspectors remove a clamshell from a
flat, open it, empty the berries onto the table and visually
inspect them. The berries are then returned to the clamshell,
replaced in the flat, and returned to the storage location
before being collected by the importers.
Removing the fruit from its container creates an
opportunity for it to become contaminated by contact with human
hands or with soil which may remain on the inspection table
from previous examinations of plants or flowers. However, while
microbial contamination could hypothetically occur in this
manner, the sheer number of event locations, shippers,
distributors and cargo clearance areas made the possibility of
raspberry contamination occurring in the United States highly
unlikely.
The FDA is also responsible for clearing imported fruit and
vegetables as well as all other imported foods, except for
meat, poultry and some egg products--which are under the
jurisdiction of the USDA's Food Safety and Inspection Service.
FDA inspectors may automatically release the fruit based on the
product's import history, or the inspectors may conduct a
physical examination of the fruit and/or collect a sample for
laboratory testing prior to releasing the product into U.S.
commerce.
Once the raspberries have been cleared at the port of
entry, importers ship the berries to distributors either by
airplane or by truck. Generally, if they are shipped in a
refrigerated truck, the flats are stacked on a pallet without
using gelpacks. If they are transported in an airplane or a
nonrefrigerated truck, they are repacked into E-containers with
gelpacks.
Distributors fill and deliver orders for fresh raspberries
placed by retail outlets and food service establishments.
Surprisingly, our investigation revealed that raspberries
harvested one afternoon on a Guatemalan berry farm can be on an
American consumer's table the very next day. The entire farm-
to-table process can be completed in less than 24 hours, even
when the farm is located in Central America.
Finally, upon receipt by the retailer or food service
establishment, fresh berries are generally stored briefly until
displayed for sale or prepared for consumption. Food
preparation is always a potential point of contamination,
depending largely on how the food is handled. That is why
proper handling practices are so important. Proper food
preparation practices include washing hands often, separating
washed and cooked foods from unwashed and raw foods, as well as
animal products from plant products.
However, as I stated previously, in these cases, it is most
likely the raspberries were already contaminated prior to
reaching the retailer or food service establishment.
In closing, I would like to quote one of my colleagues from
the CDC, Dr. Morris Potter, who I believe accurately summarizes
the challenge posed by foodborne illness: ``If one recognizes
that ensuring food safety is inherently uncertain, foodborne
illnesses become opportunities to learn rather than failures to
predict. Foodborne disease will occur, and we must be prepared
to react quickly to reduce the risk of new foodborne hazards.''
Further, I would like to emphasize that we live in a Nation
that trades food on a global basis. In efforts to ensure the
safest U.S. food supply possible from farm to table, it is
essential to remember that increasingly, the farm is in another
country.
In 1996, the United States imported $7.2 billion worth of
fruit and vegetables from at least 90 different countries, an
increase of 48 percent from 1990. And this trend will continue.
The FDA has projected that imports of fruit and vegetables
will go up by another 33 percent between now and the year 2002.
The United States will continue to import foreign produce to
meet the demand of American consumers for a variety of fresh
fruit and vegetables year round. Therefore, food safety is an
international issue.
Thank you again, Madam Chairman, for the opportunity to
present this phase of the Subcommittee's food safety
investigation. I am, of course, available to answer questions.
Senator Collins. Thank you, Dr. Smith.
Dr. Foran.
TESTIMONY OF DR. JEFFERY A. FORAN,\1\ CYCLOSPORA CASE PATIENT,
AND EXECUTIVE DIRECTOR, RISK SCIENCE INSTITUTE, INTERNATIONAL
LIFE SCIENCE INSTITUTE
Dr. Foran. Thank you, Senator.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Foran appears in the Appendix on
page 161.
---------------------------------------------------------------------------
I am Dr. Jeffery Foran. I am Executive Director of the
International Life Science Institute (ILSI), Risk Science
Institute here in Washington, DC. The ILSI Risk Science
Institute is a nonprofit institute established in 1985 to
advance and improve the scientific basis for ecological and
human health risk assessment. RSI works toward this goal
through an international program of research, working groups,
conferences, workshops, publications, seminars and training
programs.
We recognize that public health decisions must be based on
the best available science and thus, in all of our activities,
we work toward consensus resolution on the scientific issues by
facilitating discussion and cooperation among scientists from
academia, industry, government, and the public-interest sector.
During the spring of 1996, I attended a buffet luncheon at
which a variety of fruit and other foods was served.
Approximately 10 days to 2 weeks after the luncheon, I
developed acute gastroenteritis and diarrhea. Several other
individuals who participated in the luncheon developed similar
symptoms, which included nausea, fatigue, loss of appetite and
weight loss.
Upon the discovery of the similarity of our symptoms, and
suspecting a similar disease etiology, we contacted the
Washington, D.C. Public Health Commission, and subsequently,
the Centers for Disease Control and Prevention. We asked them
to investigate the potential for food-related causes of these
symptoms.
During the investigation of the nature of these symptoms, I
visited my physician to determine what might be causing my
illness. My physician did not at the time suspect a foodborne
illness. Rather, he suggested that my fatigue and weight loss
might be due to stress and a very hectic schedule. No
medication was prescribed during my first visit.
After this visit, we began to learn through the news media
of a foodborne pathogen, Cyclospora, which elicited symptoms in
exposed individuals that were identical to my own, and others
who participated in the luncheon.
I recontacted my physician upon learning of the symptoms
caused by Cyclospora infection and the appropriate treatment.
The CDC subsequently confirmed the outbreak of cyclosporiasis
in individuals who attended our luncheon. I then received
medication and was relatively free of symptoms within 14 days
of receiving medication. Subsequently, we learned from the CDC
investigation that Cyclospora most likely occurred on the
raspberries that were served during the luncheon, and that
these raspberries were most likely imported to the United
States.
For several years, the ILSI Risk Science Institute has been
developing a method to assess the human health risks associated
with exposure to food- and waterborne pathogens. The disease
outbreak in individuals who attended the luncheon has provided
valuable, although I admit somewhat uncomfortable, personal
lesson of the value of our work. In 1996, RSI published an
article entitled ``A Conceptual Framework to Assess the Risks
of Human Disease Following Exposure to Pathogens.'' \1\ This
framework, which was developed by a group of 30 scientists
convened by the ILSI Risk Science Institute, highlights the
information that must be gathered to fully understand the
health risks posed by exposure to food and waterborne
pathogens. Critical to such an assessment is information on the
nature of the pathogen itself--for example, where it occurs,
its life-cycle, its ability to cause disease; the nature of
exposure to the pathogen--how, when and how much we might be
exposed to it; information on host susceptibility, the health
effects caused by the pathogen, the severity of the disease in
the host, the nature of the dose/infectivity/response
relationship between the pathogen and the host, and an array of
other factors.
---------------------------------------------------------------------------
\1\ See Exhibit No. 8, Attachment G which appears in the Appendix
on page 142.
---------------------------------------------------------------------------
Unfortunately, much of this information is not available
for many pathogens that infect humans and cause diseases. For
example, with regard to Cyclospora, at the time of our
outbreak, most physicians and public health experts did not
fully understand the nature of the organism, its occurrence,
its infectivity, and many other issues necessary to
characterize the human health risks associated with exposure to
the organism. And even after significant investigation,
scientists have still not resolved several of the critical
issues about Cyclospora as well as many other pathogens, such
as the nature of the dose/infectivity/response relationship,
which is a key issue in conducting a quantitative risk
assessment.
Stated in a simpler fashion, we did not at the time of our
outbreak and still do not know how many contaminated
raspberries one must eat to become infected, or what
concentration of Cyclospora oocysts must occur on a single
raspberry to result in infection.
Clearly, the state of the science is poorly-advanced an
likely incapable of supporting a comprehensive and conclusive
risk assessment for Cyclospora.
Similar uncertainties confront the risk assessment
community with respect to many other food- and waterborne
pathogens.
Now, why is risk assessment for pathogens so important?
Risk assessment is a process that facilitates the organization
of information on health risks posed by exposure to pathogens.
Organization of information on health risks is necessary
because of the complexity of such information and the
likelihood that without such an organizational process,
critical pieces of information leading to an understanding of
the health risks will be missed.
Additionally, the use of risk assessment methods to gather
and organize information on health risks facilitates the
identification of knowledge and data gaps that must be filled
to fully understand and characterize risks.
Finally, and I think most important, quantitative risk
assessment can provide a probabilistic expression of health
risks. This information is critical in assessing the efficacy
of control technologies, in comparing the benefits of different
control technologies, in the conduct of cost/benefit analyses,
and in facilitating the development and selection of policy
options to manage health risks. Without a quantitative
assessment of health risks, we are left with simple guesses as
to which control technologies or policies are most appropriate
to reduce health risks associated with exposure to food- and
waterborne pathogens.
Risk assessment is not a panacea. It will not prevent all
human infection and disease. And without reliable data, or used
improperly, it can even provide misleading information.
However, when used correctly and conducted with reliable data,
risk assessment will provide and encourage the development of
information that will lead to informed decisionmaking. It can
also provide predictions of potential health risks, which can
then be managed before disease occurs in human populations. At
its best, it could even play a role in preventing the outbreak
of cyclosporiasis and other pathogen-related diseases.
For this reason, adequate resources must be made available
to conduct comprehensive risk assessments for food- and
waterborne pathogens and to address the many uncertainties and
knowledge gaps that accompany the risk assessment process.
I appreciate the opportunity to present these remarks and
will be glad to entertain questions.
Senator Collins. Thank you very much.
Dr. Ostroff, it is my understanding that you are going to
be presenting for the CDC today.
Dr. Ostroff. That is correct, Senator.
Senator Collins. Please proceed.
TESTIMONY OF DR. STEPHEN M. OSTROFF,\1\ ASSOCIATE DIRECTOR FOR
EPIDEMIOLOGIC SCIENCE, NATIONAL CENTER FOR INFECTIOUS DISEASES,
CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GEORGIA,
ACCOMPANIED BY DR. BARBARA L. HERWALDT, MEDICAL EPIDEMIOLOGIST,
DIVISION OF PARASITIC DISEASES
Dr. Ostroff. Let me begin by thanking you and other Members
of the Subcommittee for holding this hearing and for your
ongoing support and interest in food safety.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Ostroff appears in the Appendix
on page 165.
---------------------------------------------------------------------------
As mentioned, I am the Associate Director for Epidemiologic
Science at the National Center for Infectious Diseases, and
thus, I am responsible for all of the outbreak investigations
that we do. I am accompanied by Dr. Barbara Herwaldt, from the
Division of Parasitic Diseases, who coordinated our
investigations of Cyclospora in 1996 and 1997.
This is a dynamic period for public health and infectious
diseases. Almost every year, we find a new disease-causing
microbe or discover the causative agent for a previously-known
disease, including ones like HIV, E. coli O157:H7, hepatitis C
and hantavirus.
Today, there are many challenges in our ability to protect
the public's health. These include changing technologies,
changes in the environment, global movements of people and
products, population growth, and social and behavioral changes.
These factors certainly operate in the area of food safety and
foodborne diseases, where forces which were hard to imagine at
the turn of the century, play a major role today, including a
globalized food supply, large-scale food production and
distribution networks, and changes in consumer eating habits.
Although Americans have one of the safest and most diverse
food supplies in the world, foodborne diseases remain a threat
to us all. It has been estimated that between 6 and 33 million
foodborne illnesses occur each year in this country. As a
result of evolving patterns of food supply and production, the
spectrum of foodborne disease is also evolving with new agents
and patterns of transmission occurring.
CDC's mission, put very simply, is to keep our finger on
the pulse of the public's health. In the food safety area, we
work with a variety of public and private partners to conduct
surveillance for foodborne illness, investigate outbreaks, and
perform special epidemiologic and laboratory studies.
In public health, surveillance means the ongoing collection
of information about health events such as cases of
salmonellosis or botulism. Traditionally, this has been done
using a system set up at the turn of the 20th Century in which
physicians, hospitals and other sources reported illnesses to
the health department. Today, these systems are simply not
adequate by themselves to address 21st Century foodborne
disease problems.
In 1994, we issued a strategic plan called ``Addressing
Emerging Infectious Diseases: A Prevention Strategy for the
United States,'' \1\ which emphasized harnessing modern
communications, computing and molecular biology to conduct our
surveillance, applied research and prevention mission. This has
been the platform for all of our activities under the
President's National Food Safety Initiative.
---------------------------------------------------------------------------
\1\ Exhibit No. 3b is retained in the files of the Permanent
Subcommittee on Investigations.
---------------------------------------------------------------------------
It seems natural to ask why the estimates of the burden of
foodborne disease are so rough. In order to determine the true
burden, a series of actions have to occur, as you will see on
the poster that is about to be displayed.
First, the illness must be serious enough for the victim to
seek medical attention. Then, the clinician must consider the
cause to be foodborne and request the proper tests. The right
specimens have to be collected, and the lab must be able to do
the right tests. The results must then be reported to the
health department and eventually to CDC.
For many cases, not all of these steps occur, and these
cases are missed. As an example, we estimate that there are 2
million cases of salmonella infection in the United States
annually, but only about one in 40 are ever identified and
reported to the health department.
CDC and its partners have been working to build better
reporting of foodborne illnesses. These steps include building
better capacity in State and local health departments for
foodborne disease investigation and lab diagnostics,
establishing automated reporting systems for foodborne
pathogens, and, for better and faster analysis of data,
creation of a system known as FoodNet in seven health
departments around the country to actively seek out cases of
foodborne illness and determine the true burden of diarrheal
disease. FoodNet is one of the major tools we must have to
demonstrate the impact of actions initiated by our partners at
USDA and FDA, such as the 1997 Food Code and HACCP measures, on
the ultimate goal of lowering the incidence of human foodborne
diseases.
Outbreaks are defined as a greater number of cases of
illness than expected within a given time frame or geographic
area. About 400 to 500 foodborne outbreaks are reported
annually to CDC. This, too, is likely to be a gross
underestimate as many outbreaks are never recognized, and
seemingly sporadic cases of illness are never linked together.
To better identify outbreaks, CDC has worked to create the
PulseNet system for molecular fingerprinting of foodborne
pathogens, much like the local police department fingerprints
criminals.\2\ This poster shows the current status of the
FoodNet system, which is nationally based, with a centralized
computer database at CDC.\3\ Whenever we find two microbes with
the same fingerprint pattern, it means they are somehow linked.
Our job is to find out how.
---------------------------------------------------------------------------
\2\ See Exhibit No. 5a which appears in the Appendix on page 55.
\3\ See Exhibit No. 5b which appears in the Appendix on page 56.
---------------------------------------------------------------------------
Using resources provided by CDC, routine use of this
technology allowed Colorado to recognize the E. coli outbreak
linked to beef patties last year, leading to the recall of 25
million pounds of ground beef. This outbreak surely otherwise
would have been missed.
Molecular viral sequencing allowed us to show that the
cases of hepatitis among schoolchildren in your home State of
Maine last year were part of the larger frozen strawberry
outbreak which was mentioned by Senator Levin in Michigan
school children at the same time.
CDC's role in outbreak investigations is very well-
illustrated by the 1996 and 1997 outbreaks of infection caused
by Cyclospora, which the other two presenters have mentioned.
Senator Collins. Excuse me, Doctor, I apologize for having
to interrupt you. We are in the midst of a vote, and I have
only 2 minutes to make it to the floor.
It seems to me this is a good breaking point, because I
know the next part of your testimony will talk specifically
about the 1996-1997 outbreak of Cyclospora which is our cases
study today.
Dr. Ostroff. That is correct.
Senator Collins. So, with apologies to everyone, I am going
to call a 15-minute recess, because we unfortunately have two
votes. I hope I will make this one, and then we will have a
second vote, and I will come back as soon as possible.
We will be in recess for 15 minutes. Thank you.
[Recess.]
The Subcommittee will please return to order. Dr. Ostroff,
I will ask you to continue with your excellent testimony.
Dr. Ostroff. Thank you, Senator.
Getting to the Cyclospora issue, CDC's role in the outbreak
investigation is very well-illustrated by the outbreaks of
infection caused by Cyclospora in 1996 and 1997. Cyclospora is
typically characterized by watery diarrhea and other symptoms
such as nausea, abdominal cramps, weight loss and fatigue. If
not treated, as was mentioned, the illness can be severe and
prolonged.
Before 1996, most of the small number of cases of
cyclosporiasis in the United States occurred in travelers who
had been in developing countries, and only three small U.S.
outbreaks had been reported.
This pattern changed dramatically in 1996 when health
departments noted cases of cyclosporiasis in people who had not
traveled overseas. In mid-May of 1996, health departments in
Florida and New York informed CDC that sporadic cases of
cyclosporiasis had been identified in their States. At the end
of May, health departments in Texas and Canada told us that
some people who had attended specific events such as a party
had become ill with cyclosporiasis. Thus, we were notified of
what we refer to as ``clusters'' of cases, which indicated that
an outbreak may be occurring.
Ultimately, 55 clusters with a total of 725 cases of
cyclosporiasis were reported to CDC by 14 States, the District
of Columbia and two Canadian provinces. These clusters were
associated with events that had occurred between May 3 and June
14, 1996. In addition, 740 sporadic cases that were not
associated with identified events or with overseas travel were
reported, for an overall total of almost 1,500 cases from 20
States, District of Columbia, and two provinces in Canada.
Twenty-two people are known to have been hospitalized, but
no deaths are known to have occurred. As mentioned earlier,
because many cases are probably not recognized, these numbers
are likely to be very gross underestimates.
CDC played many roles in the outbreak investigation,
including serving as the national reference laboratory for
identifying Cyclospora in stool specimens, thus confirming that
the parasite caused the outbreak. This role was particularly
important because many laboratorians had not had any experience
in identifying Cyclospora.
We also helped State and local health departments conduct
the studies that ultimately implicated raspberries as the food
item that had made people sick, focusing on the clusters of
cases that were associated with specific events. Health
departments interviewed the people who had attended the
respective events about what they had consumed and compared the
responses of the sick and the well people to see how they
differed. CDC assisted in various ways--for example, by helping
to design the questionnaires, conduct the data analysis, and
identify important issues that needed to be addressed in the
investigations. In several instances, we actually fielded teams
to assist the State health departments with the investigations.
As more and more clusters of cases were identified, CDC's
coordinating role at the national level became more important.
We sponsored frequent conference calls for all participants who
were doing investigations and a meeting in July 1996 to discuss
the findings to date and help establish priorities for the
investigation and for future research.
Whereas the investigators from the individual States and
localities were able to focus on their own jurisdictions, our
job was to look at the overall national patterns that emerged
as data from the individual clusters was compiled and analyzed.
Fresh raspberries were found to have been served at
virtually all of the clusters of events, and a strong
statistical association was found between illness and
consumption of raspberries. Studies that compared the exposures
of sporadic cases and control subjects were also conducted and
also implicated raspberries.
Once it was determined that raspberries were the food item
responsible for illness, the next step was to determine where
they had been grown, a process which required close
coordination with FDA, State and local agencies, and industry.
The tracebacks entailed determining where the various events
took place and where the raspberries that were served had been
bought. The raspberries were then tracked from suppliers and
distributors back to importers, exporters and farms of origin,
looking for common themes at each step. The available traceback
data implicated Guatemala as the common source for the
raspberries.
Investigators next tried to determine how the raspberries
became contaminated. We sent investigators to Guatemala and
Miami, a major port of entry for imported raspberries, to
explore possible modes of contamination. We were able to
observe how raspberries were grown, picked, sorted, packed,
cooled, transported and inspected. Because no step along the
path after the berries left the farm was linked to all events
for which we had adequate data about the source of the
implicated raspberries, we concluded that some practice or
attribute common to multiple farms was the most likely
explanation for the outbreak.
As was mentioned, one hypothesis was that contaminated
water may have been used to mix the insecticides, fungicides
and fertilizers that were sprayed on the raspberries. Good
laboratory methods for detecting low levels of the parasite on
produce such as raspberries, or in water and other
environmental samples, are not available. By the time the
clusters of cases were detected, leftover raspberries from the
events were not available for testing.
Although the precise mechanism by which the raspberries
became contaminated was unclear, FDA and CDC provided
suggestions to the Guatemalan Berry Commission about possible
ways to reduce the risk for contamination. The Berry Commission
voluntary implemented various prudent measures to improve water
quality and sanitary conditions on farms that were going to
export to the United States in subsequent export seasons.
Despite these control measures, another multi-State
outbreak linked to Guatemalan raspberries occurred in North
America in the spring of 1997. CDC learned of this outbreak in
early May 1997, when several health departments informed us of
clusters of cases that were associated with April events.
Ultimately, 41 clusters with over 700 cases were reported which
were associated with events that occurred April 1 through May
26, 1997, in 13 States, the District of Columbia, and one
Canadian province. Counting the sporadic cases, more than 1,000
cases in 17 States, District of Columbia and two provinces were
identified.
Once again, the investigation which focused on the clusters
of cases implicated fresh raspberries and Guatemala was found
to be the major source of the implicated berries. The outbreak
ended shortly after Guatemala voluntarily suspended exportation
of fresh raspberries to the United States at the end of May
1997.
Why did the second outbreak occur? One possibility is that
the control measures on the farms were never adequately
implemented. Another is that the true source of contamination
was not found, so that the measures which were taken did not
control the problem. The latter is certainly possible since
there are so many critical questions about this parasite which
we cannot answer.
For instance, we do not know where the parasite lives in
nature. With no animal models for the disease, it cannot be
easily studied in the laboratory setting. Infected human stool
is the only source we have for this parasite, so a ready supply
of the organism is not very easy to obtain. We have no test to
tell us whether the parasite is alive or dead, other than when
it causes human illness, and no subtyping methods like we do
for some of our other pathogens. Most importantly, we do not
have a good test for it in fruit or in water.
Although this parasite can be cured with antibiotics, as
our mothers told us, an ounce of prevention is worth a pound of
cure. Lacking these answers, the only preventive measure
available to FDA was to restrict the import of Guatemalan
raspberries into the United States between March 15 and August
15 of this year. So far, this step seems to have worked, since
we have seen no Cyclospora outbreaks linked to raspberries in
the United States this year.
The Cyclospora story is a model for emerging foodborne
diseases in many ways. This includes a newly-recognized
pathogen, many unanswered scientific questions, an unusual food
vehicle for disease, a high-profile disease outbreak involving
thousands of people over multiple States and countries, and
economic and diplomatic overtones.
As we move into the next century, we are likely to see more
stories like Cyclospora that involve a newly-recognized microbe
and many unanswered questions. We must have the tools at hand
to rapidly recognize and respond to these new foodborne
threats. As we work toward this goal, the number of reported
cases and outbreaks will probably first go up rather than down.
This should be viewed as good, as it means we will be seeing
the problems that we now surely miss. We can only devise
appropriate preventive measures and assure ourselves that our
risk reduction strategies work if we know what the problem are
that are out there. We owe this to you and to the American
consumer as we move into the next century.
Thank you for your time, and both Dr. Herwaldt and I would
be happy to answer any of your questions.
Senator Collins. Thank you very much, Dr. Ostroff.
Dr. Ostroff, let me start by asking you a question about
the recent outbreak of Cyclospora in Canada. You mentioned just
now that the United States took steps to ban the export of
Guatemalan raspberries, which seems to have prevented the
spring outbreak in the United States that occurred during 1996
and 1997. In Canada, however, we have had a spring outbreak of
Cyclospora just this year. Can you tell us anything about the
Canadian outbreak? Is CDC involved at all in assisting the
Canadian public health authorities in trying to do the
traceback process?
Dr. Ostroff. Yes. Let me answer very briefly and then I
will ask Dr. Herwaldt if she has anything to add.
We have been assisting the Canadians in looking into the
outbreaks, the clusters, which have been recognized so far in
1998. Our understanding is that there have been 14 separate
clusters that have been recognized involving about 200
individuals. Certainly the preliminary data--and those numbers
will probably change; they are very preliminary--suggests that
these outbreaks are once again linked to raspberries. The
preliminary information in terms of the tracebacks suggest that
the source was Guatemala.
Again, we have been assisting the Canadians in terms of
conducting the investigations as well as the tracebacks.
Barbara, do you have anything to add?
Dr. Herwaldt. No. I would just like to reiterate what Dr.
Ostroff said. The investigation is ongoing. All the numbers are
preliminary. Both clusters and sporadic cases have been
identified, and as he pointed out, both the epidemiologic and
traceback investigations to date are leading us and the
Canadians to the conclusion that again, Guatemalan raspberries
have caused this outbreak.
Senator Collins. Dr. Herwaldt, I would like to examine with
you in more detail the traceback process. Senator Lieberman
aptly described it as being akin to a medical detective story,
and I think it is, in many ways.
I know that the CDC is not responsible for every part of
the investigation, but I would like you to respond based on
your knowledge of how other entities cooperate with the CDC and
give us a fuller picture of the traceback process going from a
patient like Dr. Foran, who became ill from eating the
contaminated raspberries, back to the farms in Guatemala.
First of all, I assume that you start with reports from
State health departments that identify an incidence of
cyclosporiasis and that they were greater than normal. But it
must have been difficult for public health authorities, given
what Dr. Ostroff has told us about the lack of information and
the lack of tests, to deal with this rather exotic microbe that
we are dealing with in Cyclospora.
Could you tell us how the reports came to the CDC and walk
us through the process?
Dr. Herwaldt. Yes. Thank you for the question.
These sorts of investigations are very complex, as you
alluded to, and difficult to conduct. It requires the
collaborative work of many persons from many agencies. As you
said, we initially hear about cases of ill persons from State
health departments, local health departments, sometimes from
the physician and sometimes from the patient himself or
herself.
Cyclospora is one of the many emerging pathogens that we
are dealing with, and many people in State and local health
departments know that we are interested in organisms such as
Cyclospora and do let us know when they hear of cases.
As has been previously mentioned, there are some severe
constraints we are operating under because many sick people may
not go to see their doctors, and many doctors may not do the
appropriate tests. They may not realize that you have to
specifically request testing for Cyclospora to have the testing
done. Many laboratories, at least before the 1996 outbreak, did
not yet have the necessary experience and expertise to identify
the organism even if they did the appropriate test.
So there were many links along the chain for us to even
hear that a case was caused by Cyclospora. Sorry, did you have
a question?
Senator Collins. Once you do get that report, is there an
interview process where you try to figure out who ate what, at
what event?
Dr. Herwaldt. Exactly.
Senator Collins. I mean, to try to identify the food
involved must be a difficult task and involve some sort of
interview process; is that correct?
Dr. Herwaldt. Yes.
Senator Collins. Tell us about that part of the process.
Dr. Herwaldt. OK. We have two types of cases, and I will
emphasize what happened with the clusters of cases. These were
associated with events, or parties. To investigate them, the
health department would use a structured questionnaire and
interview both sick people and well people, asking them not
only about their symptoms, but about everything they ate and
drank at the event. Then they would compare the exposures of
the sick people and the well people to see how they differed.
Then, statistical tests would be used to determine what could
differentiate the exposures and determine what caused the
illness.
We had both the blessing and the curse of having multiple
clusters. We did not have just one little one; we had multiple
ones. It was both a blessing and a curse. It was a curse
because, obviously, it required much more work, but it was a
real blessing because it strengthened our conclusions and made
them all the more compelling because we had the same
conclusions being reached by multiple investigators scattered
all across the country and also in Canada.
Senator Collins. When did it become evident that the
raspberries were the culprit?
Dr. Herwaldt. Well, there are a couple of different kinds
of evidence. First and foremost, the mere fact that raspberries
overwhelmingly were the common theme was an important
observation. Of course, that was not clear at the very
beginning because we just knew of a few clusters at that time.
But as we heard of more and more clusters and more and more
events and learned about the menus, it became quite obvious
that raspberries were the common theme.
Then, we moved one step beyond that. We did not rely on
that alone. We also wanted strong statistical evidence that
could compellingly say with real confidence that it was the
raspberries.
Senator Collins. Once you identified raspberries as the
source, how did you then go about determining where the
raspberries came from?
Dr. Herwaldt. In all aspects of the investigation, we
looked for common themes. That was true for the epidemiologic
aspects, and it was true as well for the traceback aspects. We
looked for common themes at every step along the way.
To trace the source of the raspberries, we had to, as Dr.
Smith pointed out, look at every step. We were going in
reverse; it was to trace back from the table back to the farm.
For example, if there was a party, we needed to find out where
the raspberries were bought, where they came from--was it a
restaurant, was it a supermarket--where that supermarket or
restaurant got its raspberries. We had to go back to the
distributors, and from the distributors back to the importers,
and from the importers back to the exporters, and from the
exporters back to the farms.
So every step along the way had to be investigated in
detail, and again, the overwhelming common theme was Guatemala,
so that we could confidently conclude that not only were
raspberries the vehicle but that Guatemala was the source of
the raspberries.
Senator Collins. Did the CDC actually visit farms in
Guatemala to try to pinpoint the source of the contamination?
Dr. Herwaldt. Yes. CDC in fact fortuitously has a field
station in Guatemala which has facilitated our investigation,
but on multiple occasions, officials from CDC here in the
States, as well as from FDA and other agencies, have gone to
Guatemala. Unfortunately, we have not been able to identify
with confidence the mode of contamination. As has been
previously mentioned, we have various hypotheses, but we do not
yet know with certainty what caused the problem.
Senator Collins. The CDC was able to trace the source back
to specific farms. As I understand it, there were 10 farms that
were visited, and your statistical analysis suggests that five
farms could have been the source of some 85 percent of the
contamination. Is that accurate?
Dr. Herwaldt. That is actually a little bit complex,
because the problem is you do not always know with certainty
which shipment of raspberries was used to supply a supermarket
or a restaurant or whatever. Then, in addition, usually,
multiple farms contribute raspberries to a shipment of
raspberries. So what we needed to do was say for an individual
event, this was the list of possible farms that could have
contributed the raspberries, and then we again looked for
common themes. We were able to say the minimum number of farms
that could have been responsible, but we did not know for sure
necessarily that it was Farm X, Farm Y, Farm Z, in all cases.
But we can say that no one farm could have accounted for the
whole outbreak, nor could any one exporter have accounted for
the whole outbreak, and that is true for the 1996 outbreak and
the 1997 outbreak.
Senator Collins. Is the CDC's best hypothesis at this point
that it is a case of contaminated water used by the farms?
Dr. Herwaldt. I would say that that is one of our major
hypotheses, and it is an attractive hypothesis for several
reasons. First and foremost, we know that this organism can be
transmitted by the waterborne route. Also, another reason the
hypothesis is attractive is we need a hypothesis that can
account for the fact that both outbreaks were rather long, and
no one farm could account for the entire outbreak. So we needed
a mechanism for contamination of relatively large numbers of
raspberries.
But given that it is an emerging pathogen, so many
unanswered questions, and we do not have definitive evidence of
how the contamination occurred, we do not want to be too strong
in what we say about how it might have occurred.
Senator Collins. Thank you.
Dr. Smith, I would like to turn to you to learn more about
the Subcommittee's investigation and specifically, your visit
to the 10 berry farms in Guatemala.
First, are raspberries native to Guatemala?
Dr. Smith. They are not.
Senator Collins. Could you tell us how raspberries came to
be grown in Guatemala and the role that the United States may
have played in that effort?
Dr. Smith. Actually, it was the United States Agency for
International Development that, through contractors, got the
Guatemalans and other Central American countries into
nontraditional agricultural crops for export.
In the 1980's, the contractors introduced blackberries, and
then the decision was made, because of the demand being higher
in the United States for raspberries, that raspberries be
considered, and in fact, in the early 1990's raspberries were
introduced.
Senator Collins. Could you tell us a bit more about your
observations on the farms that you visited? Did they vary as
far as the conditions you found on the farms, or were they all
approximately the same? Tell us more about your personal
observations as a food scientist when you were in Guatemala.
Dr. Smith. Actually, at the time we were there, which was
the end of March, beginning of April of this year--and some
things have changed since then as far as measures put in
place--but at the time, they were categorizing based on a set
of criteria, and they had inspectors give scores. The criteria
included water source, the packing shelter, materials that were
used to make the structure itself, recordkeeping, personal
hygiene of employees. These kind of things were considered, a
numerical value was given, and then, based on that numerical
value, the farms were categorized high, medium or low risk.
Since then, the high-risk farms have gone out of business,
and I believe even since then, some of the medium-risk----
Senator Collins. Excuse me. Since your visit, some of the
high-risk farms where you observed conditions that caused you
concern are now no longer in production; is that correct?
Dr. Smith. Actually, we did not even go to a high-risk
farm. We saw a medium-risk farm, and medium-risk farms are now
out of business, too.
So when AID first went down, there were about 12 farms that
they worked with, and that grew to about 150 farms, and the
most recent information I have is that they are back to about
26 farms. So that only the farms doing the best job with the
best infrastructure are still remaining and being considered
for potentially exporting to the United States next spring.
Senator Collins. Understanding that the farms that you
observed may no longer be producing, could you describe some of
the conditions that caused you concern and that could be a
possible source of cyclosporic contamination?
Dr. Smith. Yes, and I will refer to notes that I took while
in that country. We did see one medium-risk farm, and one
concern that I had was dirty toilet facilities. Actually, when
I went to wash my hands after using the facility, I could not
get water out of it; but I was shown to a sink inside which the
employees were using, and there was water with soap and paper
towels. Again, that was a medium-risk farm and is no longer in
existence.
Senator Collins. Dr. Foran, one of the most fascinating
aspects of your testimony was that when you became ill, you
went to your physician, and your physician was not able to
diagnose you originally as having a foodborne illness. It
sounds to me like you more or less put the evidence together
yourself when you heard of your friends who were at the same
luncheon, who also had similar symptoms.
In addition, I believe that you read about press reports of
Cyclospora. Is that accurate?
Dr. Foran. Yes. The group of us that participated in the
luncheon all developed the same symptoms, identical symptoms,
at the same time. As a scientist, but even as an individual,
that was well beyond any expectations of coincidence.
That led to the first suspicion, although we did not know
the disease or what was causing the symptoms. But shortly after
that, we saw an article in The New York Times that described an
outbreak of cyclosporiasis, I believe it was in New York, and
it described the symptoms associated with that outbreak, and
they were identical to our own. At that point, simply putting
two and two together was very easy.
Senator Collins. Dr. Ostroff, that suggests that public
disclosure of foodborne illnesses is very important, because in
this case, it enabled Dr. Foran to get treatment that he might
not otherwise have gotten. And while it is my understanding
that people do not die of cyclosporiasis, there are other
foodborne pathogens that can cause death.
How does the CDC decide when it has enough evidence of a
foodborne illness to make that information public and thus to
alert unsuspecting clinicians or patients that they may in fact
be suffering from a foodborne illness?
Dr. Ostroff. Senator Collins, that is an excellent
question, and it is an issue that we constantly struggle with
as we conduct investigations with our partners at the State and
local levels of foodborne disease outbreaks.
A similar example in the last couple of months has been the
salmonella outbreak in the Midwestern States which turned out
to be associated with the toasted oats cereal.
Part of the difficulty is that if you make an announcement
before you have all the data you need to assure yourself with
scientific certainty that you are correct, you could
potentially implicate the wrong product, that would put a smear
on a product and an industry that you will have difficulty
dealing with. In addition, it will not be preventing any
illness.
Alternatively, if you wait too long, you decrease the
likelihood that you are going to be able to prevent additional
cases of disease.
In addition, certainly at the Federal level and at the
State level and at the local level, there are very different
priorities in terms of being able to get information out to the
public about a perceived risk. It requires an enormous amount
of coordination to be able to successfully know the precisely
correct moment to inform the public about these problems.
One thing that we have done at CDC is to work very
collaboratively with our partners at the State level and the
Council of State and Territorial Epidemiologists to set up a
group that can get together 24 hours around-the-clock to
discuss all of the epidemiologic information that has been
collected up to a certain point. This allows us to make a
unified determination about whether we have enough to go public
with the information. This is one of the things we have set up
in the last year or two to specifically deal with the problem
that you have identified.
Once we feel that we do have that information, we make the
full court press to the degree that we can to get this
information out, both in terms of presenting the information to
the media, putting reports in our weekly report, which is the
Morbidity and Mortality Weekly Report. With the increased
scrutiny and attention that foodborne outbreaks are getting,
the level of media interest has increased astronomically, so
there is much more attention and much more likelihood that
people will hear about these problems, but it is a very
delicate issue.
Senator Collins. Thank you.
Senator Lieberman.
Senator Lieberman. Thank you, Madam Chair. I regret that I
have been in and out today, because this hearing is of real
interest to me, but I did get a chance to read the testimony
that was submitted beforehand, and I appreciate very much your
presence here today.
Dr. Smith, I want to start with you, and again, thank you
for your excellent work for the Subcommittee. In your
testimony, you mention that pesticides in the Guatemalan farms
are often mixed with what is described as drinking-quality
water. I noticed a memo which was an attachment to the
Permanent Subcommittee on Investigations' excellent report,
from a Dr. Marta Ackers of CDC, which described water that does
not sound very appealing, which is to say that several of the
implicated farms drew from open reservoirs, shallow wells or
rivers which were subject to contamination. It continues, ``On
at least one farm, the river from which the farm obtained its
water supply was noted to have people bathing in it upstream,
in addition to garbage floating in it.''
And the article in The New England Journal of Medicine
describing this outbreak refers to wells maintained near deep-
pit latrines or seepage pits.
My question is is it fair to assume that the drinking water
quality in Guatemala falls far below the health standards that
we would apply to that term here in the United States--or, am I
being unfair in taking that term ``drinking-quality water''----
Dr. Smith. I think I know what you are getting at, Senator.
Certainly, even in Guatemala, I do not think they would
consider that ``drinking-quality'' water. And what is important
to keep in mind is that that report referred to the outbreak
which occurred in 1996, and since that time, there have been
continual efforts, and in cooperation with FDA and CDC, the
Guatemalans have tried to put in place practices that are
closer to what the United States does to the point now where I
would say that they are very comparable. And the most recent
proposal submitted by the Guatemalan Government in order to be
allowed to export to the United States next spring would be
that their three best farms, which FDA is requiring have
filters, where the mesh is actually small enough that it would
not allow the Cyclospora organism to get through, to be used
prior to the water being used in any way associated with the
plant.
Senator Lieberman. So the conditions described in Dr.
Acker's memo from CDC and in The New England Journal of
Medicine article, which are certainly unappetizing and
unsanitary----
Dr. Smith. And unacceptable.
Senator Lieberman [continuing]. Unacceptable--to the best
of your knowledge of the circumstance now, those are being
changed, or being improved.
Dr. Smith. Correct, and that has been with assistance from
the U.S. Government agencies. CDC and FDA have been providing
assistance. The Guatemalans have also hired U.S. scientists as
consultants to help them get proper procedures in place and
improve their infrastructure.
Senator Lieberman. OK. Just to show how complicated this
can be, but you will help me understand it--let us assume they
install the kind of very modern, elaborate filtration system
for the water. How do we assure ourselves that they are
guarding against surface water runoff which may bring with it
contaminants--or is that less of a real concern?
Dr. Smith. The primary concern would be water that is
intentionally put on the plant. Certainly, runoff is also a
concern. Part of the problem here is that we do not really
understand what the source of the contamination is, and if we
had a better understanding of how it was getting introduced
onto the product, we could take preventive measures
accordingly.
So that has been the challenge. This organism--and Dr.
Herwaldt can comment more about the organism's unique
characteristics--but it seems to be highly seasonal and has
been associated with the rainy season.
So the more we learn about this particular organism, the
more it is going to help with taking the proper preventive
measures and interventions necessary.
Senator Lieberman. That leads me to the next question. I
was very interested in the chart and the way you tracked the
raspberries from the farm in Guatemala to the stores and in a
sense to the tables here in the United States. I want to go
back to the port of entry when the raspberries entered. Am I
correct that the U.S. Department of Agriculture does inspect
the raspberries at that point?
Dr. Smith. That is correct, APHIS.
Senator Lieberman. And what is the nature of that
inspection?
Dr. Smith. That is merely a visual inspection. The
inspectors actually put the fruit or vegetable out on a table
and look for insects--live insects would be actionable--or
signs of disease.
Senator Lieberman. In the fruit itself?
Dr. Smith. Yes, or maybe there would be a soft, brown spot.
Senator Lieberman. Which again would be visibly observable?
Dr. Smith. Correct.
Senator Lieberman. And the goal there is--certainly, with
the inspections, I presume the goal is to stop insects from
coming in that could affect----
Dr. Smith. U.S. crops.
Senator Lieberman [continuing]. U.S. crops. And the visual
inspection is for what we might call just bad fruit which would
affect people who would eat it, or----
Dr. Smith. That is the distinction I need to make, that the
mission of APHIS----
Senator Lieberman. Why don't you spell it out for us?
Dr. Smith. I am sorry. It is the Animal and Plant Health
Inspection Service, and that is under the Department of
Agriculture. Their mission is to protect the United States
plant and animal resources. So they are not looking at food for
human disease, and it is incidental in some ways that plant
materials are actually food. So they are looking at it as
plants rather than as food.
Senator Lieberman. And at the port of entry, does the FDA
play any inspection role?
Dr. Smith. The FDA does. They have to clear each entry.
That may just involve looking at the paperwork that comes with
the entry. It could also involve, however, visual inspection,
going and looking at the product, and in addition they may
decide to sample the product and have laboratory testing done.
Senator Lieberman. Do you have any idea what the nature of
the inspection of this particular run of Guatemalan raspberries
was when it came in?
Dr. Smith. I do not know.
Senator Lieberman. But is it fair to conclude that at this
point, just to make the point, our law and its implementation
really does more to protect plants and animals in the United
States than it does to protect people who eat the fruit or
vegetables coming in?
Dr. Smith. Certainly, APHIS looks after plant and animal
health. I would not say that FDA does not look after human
health, though. I think the issue here is that Cyclospora
cannot be detected visually, and there is not even a laboratory
test for it.
Senator Lieberman. I want to get to that. I guess the point
I want to make is that from what I understand--and it is
unsettling, but it is something that I hope we will deal with--
on the average, fruit and vegetables coming into the United
States are much more likely, because there is a larger
apparatus there to be researched, to be inspected by APHIS of
the Department of Agriculture for possible damage to plants and
animals in the United States, than to be inspected by FDA for
possible damage to people, because FDA does not have the same
resources to do it. You can almost always be sure that there
was some kind of visual inspection of the fruit by the
Department of Agriculture, and clearly not so by the Food and
Drug Administration.
Dr. Smith. I was told by an APHIS inspector that their
target is 2 percent per shipment.
Senator Lieberman. Two percent of every shipment is
inspected.
Dr. Smith. Correct.
Senator Lieberman. Then, the second point that you made is
an important one, and this goes to the question of how do we
come up with a remedy that not only looks good, but really does
something, which is that when we are talking about organisms
like the one involved in cyclosporiasis, a visual inspection
would not do anything; right?
Dr. Smith. That is correct.
Senator Lieberman. Let me ask the CDC, is it conceivable
that we might get to a point--is there technology being
developed where we might get to a point where fruit and
vegetables coming into the United States could be subjected to
some kind of inspection that would reveal pathogens like this
one, or all the others that have caused illnesses?
Dr. Ostroff. I guess, Senator, the easy answer to that is
that at some point in the future, we may reach that point, but
ultimately, the better thing would be to not have to worry
about having to do the test in the first place. Certainly,
especially for fruit and vegetables, if you look at the
raspberry issue, raspberries are very highly perishable. That
is why, in terms of the process that Dr. Smith was describing,
you have to very rapidly get them from farm to table, or they
have perished. To potentially have to hold them up to conduct
this type of testing and receiving the results, would decrease
the relevance.
Senator Lieberman. So the science here is a ways away.
Dr. Ostroff. Yes, that is correct.
Senator Lieberman. And as we think about remedies for this
problem to protect people from diseases carried by food
imported into the United States, it may be--the discussion that
Dr. Smith and I had indicated that FDA does not really have
much in the way of inspection at the port of entry--that the
real point here is the other one we are talking about and that
you have worked on here, which is to try to establish standards
in the country of origin, of growth, to raise the level to
guarantee that we are going to eliminate the possibility for
these diseases which really cannot be seen in an easy way. We
are not even sure now exactly what caused this outbreak, are
we?
Dr. Ostroff. No. That is correct, Senator.
Senator Lieberman. Madam Chair, I have a few more
questions, and I can yield back to you or follow your judgment
as to whether you want to do another round.
Senator Collins. Why don't we do one more round. I only
have a few more myself.
Senator Lieberman. Fine. Thank you.
Senator Collins. Dr. Herwaldt, I was reading one of the CDC
reports which contained the intriguing information that the
Guatemalan population experiences during the rainy season what
I guess is called ``mal de Mayo,'' which is a gastrointestinal
disease that seems to come in the spring. Similarly, it appears
that the Guatemalan raspberries that are tainted with
Cyclospora are also seasonal. There does not seem to be a
problem in the fall, the winter or the summer, but just in the
spring.
Do you think there is a connection? Does that suggest that
Cyclospora is the cause of the illness that the Guatemalans are
suffering through in the spring and also could be--I am just
asking. I was intrigued as I was reading through the report.
Dr. Herwaldt. We wish we could answer that question, and
actually, it is probably a series of questions. It is a very
intriguing thought, and it is one that we have been wrestling
with since these outbreaks occurred.
The first point is an important one, which is that this
does appear to be a seasonal disease, not only in Guatemala,
but in some other countries where it has been studied. In
Guatemala, human infection does peak during the spring months.
But as we have pointed out before, we still do not know how the
raspberries became contaminated, and therefore, do not know
whether humans played a role in that contamination either
directly or indirectly.
Certainly, ``mal de Mayo'' is caused by a number of
different microbes, so it is not just Cyclospora. Cyclospora is
part of ``mal de Mayo,'' but it is not all of ``mal de Mayo.''
We need to have a better understanding not only of ``mal de
Mayo'' but of the seasonality and what accounts for it.
We can say that the 1997 outbreak actually began before the
rains began in earnest, and therefore, although moisture may
play a role, it is probably not as simple as saying that when
the rains begin, then Cyclospora begins. We do not have all the
answers.
Senator Collins. Let me ask you a question, Dr. Ostroff--I
was not trying to play medical detective there, but it does
strike me as an interesting coincidence that suggested a
possible link. Another question that has been raised is why
raspberries and why not blackberries, which are also grown in
Guatemala. We have two electron photomicrographs of a raspberry
and a blackberry, and as they are shown here,\1\ you can see
that the surfaces of the two berries appear to be very
different.
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\1\ See Exhibit No. 4 which appears in the Appendix on page 53.
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Could the differences in the berries' surfaces account for
why Cyclospora has been associated with Guatemalan raspberries
but not Guatemalan blackberries? Is that something that has
been looked at?
Dr. Ostroff. I think it is certainly one hypothesis that
may indeed play a role. If you look at these pictures, it is
obvious that the surface of raspberries, especially when you
look at them under a microscope, is quite convoluted. There are
lots of crevices and lots of nooks and crannies on the
raspberries. We know that some of those nooks and crannies are
the exact size that makes a very nice place for an organism
like Cyclospora, which is 8 to 10 microns in size, to hide out.
That is certainly one possibility.
What we do know is that the overwhelming preponderance of
the data that was collected in 1996 and 1997 certainly
suggested that raspberries were the major culprit. It does not
mean that we could totally exonerate blackberries, because
certainly in many of these clusters, at many of these events,
at many of these parties and weddings, we know that what was
actually served was a fruit cup, or some item which had
multiple different berries including, in some instances,
blackberries.
We cannot say with absolute certainty that there has not
been any illness associated with blackberries. What we can say
is that the overwhelming amount of the evidence certainly
suggests that raspberries were the major culprit here.
Senator Collins. Thank you.
Dr. Foran, could you elaborate more on the role that you
think risk assessment could play in helping us get a handle on
this problem of foodborne pathogens?
Dr. Foran. I was intrigued by Senator Lieberman's question
or statement at the end of his observations, which I thought
were excellent, about the level of guarantee I think he
suggested, and should we be able to implement a particular
technology, say, in Guatemala to deal with Cyclospora. I would
phrase that question just a little differently, that is, rather
than suggest that we want to know something about the level of
guarantee, we want to know something about the level of risk
reduction, and that is where risk assessment comes in.
Suppose we implement technology--a filter of some sort to
remove the pathogen. Well, it is unlikely that there is
anything we can do that completely removes the pathogen from a
process. So the consequence will be that we will have some
pathogen leftover.
I think the question we have to ask is how much pathogen is
left over, and how much risk does that pose when it is left
over, assuming that some of those raspberries will have a small
amount of pathogen left on them when they come into the
country.
Again, that is where risk assessment can play a very
important role. One, it can predict the risk associated with
eating the raspberries when there is a small amount of pathogen
left on them, so it can help us understand the efficacy of the
technology that we use to reduce pathogen.
Two--and what is more likely with regard to Cyclospora--it
is going to tell us that we do not know what the answer is, and
we do not know what the answer is because there is a whole
array of uncertainties--we do not understand the dose/
infectivity/response relationship; we do not even understand
how to detect the organism.
I argue that risk assessment is a very effective tool in
organizing and identifying the uncertainty and the scientific
questions that we have to address through research so we can
ultimately go back and make that prediction and make that
estimate of the level of guarantee that we have got a safe
product.
Senator Collins. Thank you.
Dr. Ostroff, it occurs to me that the increase in food
imports, particularly of imported produce in this country, has
allowed us to try exotic new fruit and vegetables that we would
not otherwise have access to. It has also improved our ability
to have year-around access to fruit and vegetables. But it
seems to me that a down side is that it has exposed Americans
to pathogens that we do not have any natural resistance to;
that perhaps these pathogens are less of a problem in their
native lands because they are indigenous, and the population
over time has built up some sort of resistance.
How do we deal with this issue? Americans want these
imported fruit and vegetables. They have given us variety in
our diets, and they are supposedly healthy for us. But we are
being exposed to emerging pathogens that we cannot even test;
we do not even have the lab tests available for them.
What do we do?
Dr. Ostroff. That is another excellent question, and I
think that is the challenge that an agency like CDC has,
because it is our job to be able to monitor for these types of
diseases as they occur. Many of these changes in dietary habits
are quite good for our cardiovascular systems, but they wreak
havoc on our gastrointestinal systems in some instances. We
know that certainly the spectrum of pathogens, or microbes,
that cause gastrointestinal disease in tropical locations are
quite different than they are in many temperate zones, like the
United States. We are being exposed, and we are seeing
outbreaks such as the one of Cyclospora.
I think another example of one that we probably would not
have seen is the recent one in Chicago, where thousands and
thousands of people became ill from an organism called
enterotoxigenic E. coli--not the E. coli O157:H7 that seems to
get all the attention--that was related to potato salad coming
from a particular deli.
We are seeing these new challenges. I am not sure I can
state with absolute certainty that there is immunity built up
in populations in tropical countries keeping them from getting
the same types of illnesses from these pathogens that we do in
the United States. I think that the systems for surveillance
and monitoring and for diagnosis are not quite in place to the
same degree that they are in places like the United States and
other developed countries.
Certainly if you look at Cyclospora, this is an organism
that was only first recognized in the 1970's, and it was
recognized in, of all places, Papua New Guinea. It is only
because somebody was looking that they even identified these
cases, and have probably gone on for some period of time.
The only answer I can give you in terms of this particular
challenge is that we need to have monitoring systems in place
in this country so we can recognize these diseases and
investigate them. I think, as importantly, that there are
systems in place in the areas where these diseases naturally
occur in the developing parts of the world so that we can
identify, as was mentioned by Dr. Foran, what some of these
risks potentially are even before they get here.
Senator Collins. Thank you.
Senator Lieberman.
Senator Lieberman. Thank you, Senator Collins.
Let me pick up briefly on the last, very interesting line
of questioning from the Chair. I gather that before 1996,
cyclosporiasis was very rare in this country and was generally
associated with people who traveled internationally; and now,
it essentially rode in on the back of the raspberries. I am
about to ask you the kind of questions that Senators ask, and I
want to give you the opportunity not to answer it, but a
question I have is are we reaching the limits of the possible
number of new pathogens coming in here because of the
globalization of our food supply that has already occurred, or
is this going to go on without limit?
Dr. Ostroff. Senator, that is a question that many people
other than Senators also ask.
Senator Lieberman. That is reassuring.
Dr. Ostroff. It is an excellent question. In this whole
area of emerging infectious diseases, if you look at the array
of different diseases and microbes that we have discovered over
the last 20 years, it is a very impressive group of pathogens.
Even in diarrheal diseases, if you just look at the
diarrheal disease arena, if you were to take a large number of
individuals who presented with diarrheal illness, and you sent
specimens off to a clinical laboratory to look for the cause of
their illness, in the large proportion of these people, the
test would not show anything. We actually test for a relatively
limited number of microbes when these specimens are sent off to
the laboratory. Even in the research setting, if we were to
apply the very best technology, all the razzle-dazzle
diagnostics that we currently have available to us, in well
over half of these individuals, we still cannot quite figure
out what the cause of their diarrheal illness is. That does not
mean that all of it is due to an infection. Some of it may be
due to other kinds of causes. What it tells us is that there
are still many bugs out there just waiting to be found, and in
the same way that if we had done a study just like that in
1980, we would not have looked for E. coli O157:H7 because we
did not know it existed until 1981 or 1982, we certainly would
not have looked for Cyclospora because we did not know it was
there. There are still lots of them out there, waiting to be
found, so, by no stretch of the imagination, have we reached
the outer limits in terms of the things that we are going to
see in the coming years.
Senator Lieberman. So there is more to worry about and work
on.
Also, as some of you indicated in your testimony, the
number of reported cases is probably lower than the actual
number of cases related to these pathogens that are brought in
on food because of the difficulty of diagnosing.
I did want to ask Dr. Foran--I was quite interested in your
own experience, and just very personally, people watching this
may wonder what was the difference in the treatment you
received, based on your own connection with the newspaper
article about this outbreak, once you told your doctor that you
thought you had a foodborne illness? In other words, was it a
significantly different treatment from the original response?
Dr. Foran. It was not just communication that it was a
foodborne illness. We were able to be much more specific than
that, because events moved so quickly. We suspected there was a
foodborne illness, and shortly after we saw the article in The
New York Times which identified Cyclospora and the symptoms
associated with cyclosporiasis, at that point, it was
absolutely clear what we had and what was causing our symptoms.
And I think that around the same time--and it has been 2\1/2\
years now--that the CDC began to become involved in the
investigation, and I believe there was enough information about
the appropriate antibiotic--and I have been trying to remember
what it was, and I cannot--but putting all that together, I was
able to go back to my physician and say we have a confirmed
outbreak of Cyclospora, here is the appropriate antibiotic,
give it to me. In essence, he did, and the rest is history.
Senator Lieberman. You are a great patient to have.
Dr. Foran. Some might argue. [Laughter.]
Senator Lieberman. In other words, there was a particular
antibiotic that you needed to take that dealt with this rather
immediately, much different from the general treatment that a
doctor--a good doctor--would give a patient who came in with
some of these symptoms.
Dr. Foran. Well, I would guess that a physician, if he or
she suspected a foodborne illness, would use a standard
antibiotic if the level of suspicion were high enough. In this
case, there was a specific antibiotic that was effective for
Cyclospora, and it was a 5-day course, and once that is taken,
it is resolved.
Senator Lieberman. I do not want to make too much of this--
but the difficulty in diagnosing is a problem because it
affects the success of the treatment.
Dr. Foran. No question, and the symptoms for cyclosporiasis
were different than symptoms associated with most of the food-
or waterborne pathogens that my physician and I assume most
physicians were familiar with at the time--Cryptosporidium, E.
coli, Salmonella, and so on.
Senator Lieberman. Thank you.
Very briefly, I have questions for the two witnesses from
CDC. First, a simple question--are you satisfied with the
cooperation that our government has received from the
Guatemalan Berry Commission?
Dr. Herwaldt. We have striven to work collaboratively with
the Guatemalans. Again, we fortuitously had a field station and
still have a field station in Guatemala which has facilitated
this whole process. You can imagine it has not been an easy
process because of the nature of what we had to work on
together. We are having to work on trying to solve a problem
related to outbreaks that have affected many people in the
United States. Both sides have worked very, very hard to come
together repeatedly and discuss what the issues are, to discuss
how best to address them and to discuss where we should go from
here. We have scientific constraints that we are dealing with,
and we are working hard with the Guatemalans so they will
understand why we do not have all the answers that they would
like us to have.
It certainly has not been an easy process, but we are happy
that the Guatemalans have been eager to talk with us and to
continue the collaboration despite the fact that there are
these difficult issues to deal with.
Senator Lieberman. And am I correct that they are under no
obligation to talk with the U.S. Government, any legal
obligation, that they are doing this voluntarily, I presume,
with an economic motivation, which is that if they do not give
some reassurance, the Guatemalan berries are not going to sell
very well in the United States.
But let me come back to my first question. Am I right that
these are discussions and cooperative efforts that are going on
voluntarily between our government and the Guatemalan Berry
Commission?
Dr. Ostroff. That is correct.
Senator Lieberman. And I ask the question just to draw
attention to the point that there is no existing statutory
authority as I understand it for the U.S. Government to apply
standards, safety standards, sanitary standards, for the
production of produce, fruit and vegetables, and I guess
grains, too, in foreign countries, as compared to the authority
that I believe the U.S. Department of Agriculture has with
regard to meat and poultry.
Is my understanding correct?
Dr. Ostroff. Senator, it would be best to have that answer
from the Food and Drug Administration because this is in their
sphere. My understanding--and again, I will emphasize, my
understanding--is that your presumption is correct.
Senator Lieberman. Maybe I should turn to our staff
witness, Dr. Smith. That is correct, isn't it, that at the
current time--and this is why we have the calls for the so-
called equivalent authority----
Dr. Smith. Equivalency, correct.
Senator Lieberman [continuing]. To give, presumably, FDA,
or maybe some part of the United States Department of
Agriculture the same authority that they have with regard to
meat and poultry to certify the production standards in foreign
countries, to give them that same authority with regard to
fruit and vegetables.
Dr. Smith. It is important to understand that under the
GATT agreements, we already have the authority to--that we have
the sovereign right is the way it is stated--to inspect food
that we import into this country to meet our level of
protection, however that is defined.
The challenge comes in how we define that level of
protection.
Senator Lieberman. And how do we enforce it.
Dr. Smith. And how do we enforce that so that it is met
domestically before we can impose it internationally. In this
situation, the Guatemalans have voluntarily allowed our U.S.
Government agencies to go into their country and work with
them, so we have not had an issue there, but that might not be
the case with other countries.
Senator Lieberman. You made a good point, that the standard
with regard to meat and poultry is that the country of origin
has to have sanitary and safety standards comparable to ours.
Is that right?
Dr. Smith. That is correct.
Senator Lieberman. Now, I am interested in what you said
about GATT. Theoretically, if we were concerned that fruit and
vegetables were coming in from a country that had deficient
standards, we could initiate an action at the World Trade
Organization?
Dr. Smith. We need to establish, though, that we do it
domestically, and currently, as far as agricultural practices,
the FDA is developing guidance on that, but there are no formal
standards or regulations in place.
Senator Lieberman. And I gather, incidentally, as a matter
of note, that only 37 countries, interestingly, have passed the
USDA test with regard to meat and poultry, so a standard has
been applied that not everybody has met.
This is one constructive way that we in Congress can go
forward, which is to give more detail and substance to what is
implicit in the GATT agreement by adopting legislation that
gives us equivalency authority to hold producing nations to
standards comparable to their own if we are going to allow
their fruit and vegetables to come in, understanding that the
more we go into this, the more complicated it gets. It is not
easy, but we can raise the standard so there is a higher
probability that the farms that they are grown on the places
where they are handled will be at higher sanitary levels, and
therefore, it is less likely that they will be bringing in
foodborne illness. I think that may end up being the challenge
for us. Now, how we implement that and whether we have to put
inspectors in foreign countries and have their agreement to
that is a topic for another day.
You have all been excellent witnesses, and I thank you very
much for your contributions.
Thank you, Madam Chair.
Senator Collins. Thank you, Senator Lieberman.
I have just a couple quick questions before I yield to
Senator Durbin. Although the United States does not currently
have an equivalency system for fruit and vegetables that
parallels the Department of Agriculture system, does the FDA
currently have authority to ban foods imported from other
countries that they believe are unsafe, and has that happened
in the case with the Guatemalan raspberries?
Dr. Ostroff.
Dr. Ostroff. As I mentioned in my testimony, Senator
Collins, and I think you mentioned this earlier, my
understanding--and again, it would be up to the FDA to provide
more detailed information--is that they cannot ban the export,
but they can restrict the import. This is what they actually
did, and they indicated that they would not permit raspberries
out of the ports between certain dates, March 15 and August 15.
That was based on the epidemiologic information that was
accumulated in 1996 and 1997 about when the risk period was for
the outbreaks in the previous years.
Senator Collins. That is my understanding as well, that
initially, the Guatemalan Government on its own suspended
shipments, but that subsequently, the FDA said that it would
not allow imported raspberries from Guatemala to enter the
American marketplace until its concerns were resolved; is that
accurate?
Dr. Ostroff. Right, and that letter was sent out in
November of last year.
Senator Collins. Thank you for clarifying that point.
Senator Durbin.
Senator Durbin. Thank you, Madam Chair.
I appreciate the testimony here today, and I read through
it, but I am sorry I could not be here for the oral
presentation in its entirety.
Let me first address what I consider to be an overarching
issue here, and I would like to have the comments of those who
are involved in this. I think that one of the major problems we
face in terms of food safety in this country is proliferation
of Federal agencies with jurisdiction. There are some 12
different Federal agencies and 35 different laws that govern
food safety and inspection.
As a case in point, this raspberry investigation that we
have showcased today involved at least four different Federal
agencies, each with specific jurisdiction over some part of the
investigation.
I have introduced legislation in S. 1465 to try to replace
this fragmented food safety system with a single, consolidated,
independent agency with responsibility for Federal food safety
activities.
I would like to note that in the last hearing before this
Subcommittee on food safety, we learned that some of the
computer systems that are used in U.S. ports of entry were not
compatible. CDC, FDA, and USDA have developed a cooperative
food surveillance project called FoodNet for foodborne disease.
I would like to ask the panel, are the computer systems
integrated such that each of the agencies has access to the
latest information on outbreak investigation?
Dr. Ostroff. Senator, not being aware of all the computer
system, I think the best answer I can give to that that exist
currently, through some of the activities that have gone on as
part of the President's National Food Safety Initiative, the
interagency food safety initiative, we have a much closer level
of cooperation. For instance, any information that the USDA has
concerning contamination of meat products, they immediately
send us either by computer or by fax, telling us of any
potential recalls. We also inform them of any investigations
that we are conducting. We tend to give them this information
even before we know whether they are foodborne or not. We know
with many of the foodborne pathogens, even with salmonella,
that sometimes we will conduct investigations, and we will find
out that the source is not necessarily a foodborne source.
Witness the recent experience that we had with the swimming
pool outbreak of E. coli O157:H7 in Atlanta.
There is a much greater degree of cooperation among the
agencies in terms of information-sharing than there used to be.
In many ways, it is actually more useful to pick up the
telephone or to send specific information than to have to wait
to massage data through a computer system.
Senator Durbin. I think we have made some progress. I think
we have a long way to go. I hope that by consolidating this
into one agency that this communication will take place. Let me
give you an illustration.
As I understand the Food and Drug Administration process on
fresh fruit and vegetables brought into the country, samples
are taken at border ports and then sent to FDA laboratories for
investigation. I have gone through this process, and once
having arrived, for example, in Nogales, Arizona, the sample is
sent off to the Los Angeles lab. The Los Angeles lab receives
it a day or two later. When the shipment is on its way to some
store, the lab is usually in the process of investigating it.
As we have established here, the lab is not going to detect the
Cyclospora problem that we have discussed. As I understand the
testimony, there is no known means of detection. The lab takes
a look at these samples for suspected problems, and they have
to start with a suspicion, because the universe of
possibilities is almost unlimited. So they start with a
suspicion that it might have an insecticide, a herbicide, a
pesticide, something on it that it should not have, and
therefore might be problematic. And again, let me confess that,
being a liberal arts major, I get lost here in a hurry, but
they set up their calibrated equipment to look in certain
spectrums of chemicals to find their presence on the fruit and
vegetables--and this is leading to a question--if they find it,
they have noticed that some shipper and some producer have a
problem. And once that is established, that shipper and
producer are treated a little differently in the future. They
start looking more closely, holding shipments for further
inspection before they are released at the border, and in the
worst case scenario, actually requiring proof that the
shipments are clean before they can go forward from the border.
In this situation, when we are dealing with a foodborne
illness like the Cyclospora problem, since it cannot be
detected at the outset, about the only thing of value is to
try, as we have in the Guatemalan raspberry situation, to trace
back and find out whether there is a problem area in some part
of the world that requires some type of effort by the United
States to reduce risk.
Dr. Smith, one of the problems as I see it in this
situation is that raspberries are usually pooled before they
are shipped, and that makes it more difficult to identify the
source farm where there was an outbreak. Do you believe that
pooling harvested fruit before shipment adversely impacts
traceback efforts?
Dr. Smith. Well, it certainly complicates the efforts. I
really do not see how we could get around pooling. We do that
here, too. That is just how you fill orders--although I believe
the Guatemalans are implementing a tracking system where they
will actually be able to tell on any shipment which farms the
berries came from. So there are some systems we could put in
place to facilitate tracebacks.
Senator Durbin. That was my next question. I wonder if you
believe that bar-coding the shipment, for example, as to the
farm sources, so that when the shipment is received, if in fact
we find a problem 2 weeks or a month later that could not have
been detected by any type of reasonable inspection, we at least
then know the source farms to go back to, and we can try to
retrace the steps and find out what the problem might be and
work with the country of origin to reduce it.
It is an investigative tool which I think might be helpful.
You say they are in the process of doing it in Guatemala. Are
other countries moving in this direction?
Dr. Smith. I really do not know about other countries. I
would suspect, though, that once one country does it, it is
going to be something that other countries will consider.
Senator Durbin. Having said that, going back to our
discussion about trade standards, I have probably just invited
the same standard to be applied to the United States exports,
and there may be some people who say it is inevitable, and
others who ask why did you bring it up--now we have to go
through the same kind of thing. But in the scheme of things,
when we are talking about so much fresh produce being exported
from country to country it strikes me that this is inevitable,
that since we cannot detect it in the clamshell baskets, once
having discerned the problem, we can at least get back to the
source.
I wonder--you made a reference earlier in response to
Senator Lieberman's question--do you think that establishing
this kind of standard would be consistent with the trade
agreements and the phytosanitary sections of those agreements?
Dr. Smith. Establishing----
Senator Durbin. The bar codes on source farms.
Dr. Smith. I think the way that it works is that it is
negotiable bilaterally with a particular country, but I know
that transparency is important, and if you are openly
discussing what measures you think are important, I believe
that would fall under GATT agreements.
Senator Durbin. Let me ask you about the whole HACCP
revolution that is taking place in terms of food inspection,
which is relatively new on the Federal scene. Is the
implementation of a HACCP-based approach to reduce the risk of
foodborne illness an effective approach with respect to the
Guatemalan raspberries and imported foods in general? That
question is for anyone.
Dr. Foran. I will be glad to start. HACCP is an approach
that implements technologies at particularly sensitive points
along the process, for example. It is called the Hazard
Analysis Critical Control Point approach.
I believe it is a useful approach for reducing hazard-
associated with foodborne pathogens, but I argue very strongly
that it is ineffective without a risk-based component to it. If
we implement a technology at a particular control point and
assume we are being effective in reducing hazards, we are just
guessing at that point.
We need a risk-based component so that we can
quantitatively estimate how effective that technology is at the
particular control point and then determine have we been
effective enough, or do we need to implement technologies at
other control points, or do we have to ban import of the
product. But without a quantitative risk assessment or an
estimate of the quantitative estimate of reduction in risk, I
think HACCP in and of itself will not be effective.
Senator Durbin. Tell me what you mean when you use the term
``quantitative risk assessment.''
Dr. Foran. It means an estimate, a probabilistic-based
number of how many people will become infected or what the risk
of an individual is when they eat a raspberry that may have
Cyclospora on it. It is a predictive estimate of the risk that
someone faces when they eat a product.
Senator Durbin. So the suggestion is that before a public
health initiative, we measure what the cost would be absent the
initiative.
Dr. Foran. Cost is another issue, and risk assessment can
help us understand cost and enlighten the issue of cost, but
risk assessment does not provide estimates of cost. It simply
provides estimates of disease probability. The cost issue,
then, can come in around the issue of suppose the technology
that we are going to implement under HACCP costs ``x'' dollars;
if we have a risk assessment to go along with that, we can make
a determination of whether we want to spend that amount of
money to get the requisite amount of risk that we predicted
with the risk assessment process.
Senator Durbin. We debate this term ``risk assessment'' on
this Subcommittee, and there is a lot of difference of opinion
here about what it means, and I for one worry about cost as an
element in risk assessment and what it means.
Your experience with foodborne illness was obviously
troubling and discomforting, but not disabling, and I take it
you have made a full recovery; but a person who is more
vulnerable--a child, an elderly person, or someone with a
compromised immune system--could have gone through a much more
difficult experience.
Dr. Foran. I think that is likely, and I will turn to Dr.
Ostroff, but I am not aware that we know enough at this point
about variability in human susceptibility associated with the
severity of disease, cyclosporiasis. That is a big unknown
right now, and it is a critical data gap that I think we have
got to fill if we are going to do a better job of understanding
the risk posed by Cyclospora and other foodborne pathogens.
Senator Durbin. That, of course, is part of the debate here
that will continue as to how do we quantify these risks. If we
want to really get down to the bottom line, as we call it, and
say how many dollars are at stake here, how many trips to the
doctor are acceptable before we can impose a new standard by
law, how many deaths are acceptable before we impose a new
standard by law, how much cost to society and how much cost in
terms of public health before we impose a new standard, a new
law, I think that is very troublesome, and as a Member of the
U.S. Senate, I think this is too close to the ``God squad''
assignment as far as I am concerned. I think that we have
historically decided to err on the side of caution when it
comes to public health and safety, and we are now calling in
the accountants to help us make the decision. I think there are
times when we may make the wrong decision and later find that
we have an unfortunate occurrence.
Dr. Foran. Senator, I would simply suggest that in my mind,
there is a big difference between cost-benefit analysis and
risk assessment. I think risk assessment is a critically
important tool to help us understand the hazards or the
probabilistic expression of risk to help us understand the
issues that are associated with being infected and having a
disease caused by exposure to a pathogen. Cost-benefit
analysis, technology issues--those are all separate. There is a
linkage there. They help each other, I think. They can work in
concert. But if we are not conducting risk assessment, if we
are not gathering the information that we need to conduct risk
assessment, we are doing ourselves a disservice because we are
simply guessing about all the other issues, about whether it is
an effective technology, whether we can rationalize the cost,
whether we even have acceptable or unacceptable risk. These are
all guesses unless we have a good, strong, quantitative,
scientifically defensible approach to understanding risk.
Senator Durbin. And you get down to the bottom line--and
someone on the panel made reference to it earlier--we now have
a choice between cardiovascular health and gastrointestinal
health, and the question that may come from this hearing for
anyone who is following it closely is, all right, let us get to
the bottom line here--is it better that I eat the fresh produce
even though I cannot be certain of its safety--is that better
for me in terms of my health, or is the risk too high in terms
of possibility of foodborne illness that I should steer away
from it and not eat the fresh produce.
Dr. Foran. There is an analogy, which I am sure you are
familiar with, with regard to contaminated fish. The argument
has been that we should not eat some fish because they carry
high body burdens of chemicals. Of course, we are not getting
the benefits of fish if we do not eat fish. How do you deal
with that?
I would argue that we should not stop at that level of the
argument. Why not take steps to make sure that the chemical
burden in fish is low enough in all fish so that they are all
safe to eat, and we do not have to worry about this? And I
would suggest that the same argument applies here. Why not take
steps as best we can to reduce the pathogen burden on the
product so that we do not have to worry about tradeoffs like
cardiovascular health and other kinds of health issues.
Senator Durbin. Thank you very much.
Thank you, Madam Chair.
Senator Collins. Thank you, Senator Durbin.
I want to thank all of our witnesses for their very
valuable assistance today. Today's hearing has focused on a
specific case study of tainted imported fruit. The intention
was to highlight the challenge we face in our effort to improve
the safety of imported food. I believe the hearing today has
underscored the fact that the safety of imported food is a
growing problem, especially with respect to emerging foodborne
pathogens, and that finding an effective solution is very
difficult when we are dealing with pathogens that cannot be
visually detected by consumers, removed by washing the fruit
involved, or in some cases, such as Cyclospora, even detected
through laboratory tests on the fruit in question.
I mentioned in my opening statement that this hearing is
the second in a series of hearings the Subcommittee will be
holding on the safety of imported food. The Subcommittee will
hold two more hearings; the next one will focus on fraud and
deception in the import process, and our final hearing will
focus on remedies and solutions. We will give Members of
Congress, the Executive Branch, and consumer and industry
groups the opportunity to provide recommendations for improving
our Nation's food import system. Our intent is a careful and
thorough examination that will provide the foundation for
effective reforms to improve the safety of imported foods.
As I mentioned, the difficulty of our task is underscored
by the fact that we have had two outbreaks of Cyclospora
associated with imported raspberries in the United States, and
right now, our neighboring country, Canada, is dealing with a
very similar outbreak.
I appreciate the contributions made by all of our
witnesses. We would also welcome any suggestions that you might
have on specific legislative recommendations; that would be
very helpful to our records as well. The hearing record will
remain open for 10 days.
Again, thank you all for your contributions to our effort.
I would also like to thank the staff of the Permanent
Subcommittee on Investigations, including Tim Shea, Dr.
Stephanie A. Smith, who has done an outstanding job for us, Don
Mullinax, Lindsey Ledwin, Mary Robertson, and the entire staff,
for their assistance.
Thank you very much. This hearing is adjourned.
[Whereupon, at 12:10 p.m., the Subcommittee was adjourned.]
A P P E N D I X
----------
PREPARED STATEMENT OF MAX CLELAND, A U.S. SENATOR FROM THE STATE OF
GEORGIA
The safety of our families' food is critical to each of us.
America's farmers have long supplied the country with nutritious,
disease-free produce. In the United States, we have come to take for
granted that the food we eat is clean and safe. In almost every
instance, it is. We in Congress need to take prudent precautions to be
sure that it stays safe. Increasingly, fresh produce is available
throughout the year from growers in other countries, some of which do
not impose the high public sanitation standards in force in the United
States. It is important, therefore, we ensure that the food we serve to
our children, from whatever country of origin, will not make them sick.
There are, however, other factors to be considered in our attempts
to control the produce growing conditions of other nations. If we act
impetuously, we may inadvertently jeopardize relations with our trading
partners. Just as the United States imports food to satisfy demand,
other countries import U.S. agricultural products. These exports are an
important market for U.S. farmers. We must also seek to maintain the
best possible diplomatic relations with our neighbors in the Western
Hemisphere. As we work with these countries to reduce the production of
illegal drugs which find their way into our country, one of the
solutions is to introduce other crops as profitable alternatives for
the growers. It is important to keep diplomatic channels open and work
together to solve problems in imports.
I thank the Guatemalan High Level Commission for Food Safety for
their cooperation with the Center for Disease Control in finding the
cause of the cyclospora outbreaks and for their written statement for
this hearing. Guatemala and the United States have been able to work
together to pursue solutions to both the health and economic problems
presented by the outbreak. This cooperation benefits both countries. We
must be careful, however, that in our attempts to regulate food safety
we do not provoke retaliatory actions by our trading partners. We must
also be sure that we do not impose expensive, unnecessary restrictions
on U.S. farmers in our food safety efforts.
I thank the Chairman for these hearings. They are an opportunity to
discuss ways to be sure that our food is safe while at the same time
maintaining our agricultural presence in the global economy.
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