[Senate Hearing 105-516]
[From the U.S. Government Publishing Office]
S. Hrg. 105-516
Part III & IV
THE SAFETY OF FOOD IMPORTS: FRAUD AND DECEPTION IN THE FOOD IMPORT
PROCESS--PART III AND IMPROVING THE SAFETY OF FOOD IMPORTS--PART IV
=======================================================================
HEARINGS
before the
PERMANENT
SUBCOMMITTEE ON INVESTIGATIONS
of the
COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
__________
PART III AND IV
__________
SEPTEMBER 10, 24 AND 25, 1998
Printed for the use of the Committee on Governmental Affairs
U.S. GOVERNMENT PRINTING OFFICE
51-562 CC WASHINGTON : 1999
_______________________________________________________________________
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, 35, 73
Senator Levin................................................ 3, 66
Senator Lieberman............................................ 6, 38
Senator Durbin............................................7, 49, 86
Senator Domenici............................................. 14
Prepared statement:
Senator Akaka................................................ 141
WITNESSES
Thursday, September 10, 1998
Lawrence J. Dyckman, Director, Food and Agriculture Issues,
Resources, Community, and Economic Development Division, U.S.
General Accounting Office, accompanied by Keith Oleson and
Dennis Richards, San Francisco Regional Office, U.S. General
Accounting Office.............................................. 8
Richard J. Hoglund, Deputy Assistant Commissioner, Office of
Investigations, U.S. Customs Service, accompanied by Philip
Metzger, Office of Field Operations, U.S. Customs Service...... 11
``Mr. Broker'', Confidential Informant/Former Customs Broker..... 27
Thursday, September 24, 1998
Hon. Paul Coverdell, a U.S. Senator from the State of Georgia.... 39
Hon. Barbara Mikulski, a U.S. Senator from the State of Maryland. 42
Hon. Edward Kennedy, a U.S. Senator from the State of
Massachusetts.................................................. 45
Hon. Tom Harkin, a U.S. Senator from the State of Iowa........... 47
Hon. Raymond W. Kelly, Commissioner, U.S. Customs Service,
Department of the Treasury..................................... 51
Thomas J. Billy, Administrator, Food Safety and Inspection
Service, Department of Agriculture, accompanied by Mark Mina,
Deputy Administrator for Field Operations, and Margaret Glavin,
Deputy Administrator, Office of Policy, Development and
Evaluation..................................................... 53
William B. Schultz, Deputy Commissioner for Policy, Food and Drug
Administration, Department of Health and Human Services,
accompanied by Joseph Levitt, Director, Center for Food and
Applied Nutrition, and Gary Dykstra, Deputy Associate
Administrator, Office of Regulatory Affairs.................... 55
Sanford A. Miller, Member, Committee to Ensure Safe Food From
Production to Consumption, National Academy of Sciences........ 57
Friday, September 25, 1998
Timothy M. Hammonds, President and CEO, Food Marketing Institute. 75
Stacey A. Zawel, Ph.D., Director, Scientific and Regulatory
Affairs, Grocery Manufacturers of America...................... 77
Dane T. Bernard, Vice President, Food Safety Programs, National
Food Processors Association.................................... 79
Nancy Nagle, Ph.D., Senior Advisor for Food Safety, United Fresh
Fruit and Vegetable Association................................ 82
Richard Levinson, M.D., Associate Executive Director for Programs
and Policy, American Public Health Association................. 95
Carol Tucker Foreman, Coordinator, Safe Food Coalition,
accompanied by Carolina Smith DeWaal, Director of Food Safety
for the Center for Science in the Public Interest on behalf of
the Food Safety Coalition...................................... 96
Ruth Kava, Ph.D., R.D., Director of Nutrition, American Council
on Science and Health.......................................... 99
Robert Hahn, Director, Legal Affairs and Research, Public Voice
for Food and Health Policy..................................... 100
Alphabetical List of Witnesses
Bernard, Dane T.:
Testimony.................................................... 79
Prepared statement........................................... 196
Billy, Thomas J.:
Testimony.................................................... 53
Prepared statement........................................... 154
Coverdell, Hon. Paul:
Testimony.................................................... 39
Dyckman, Lawrence J.:
Testimony.................................................... 8
Prepared statement........................................... 109
Foreman, Carol Tucker:
Testimony.................................................... 96
Prepared statement........................................... 229
Hahn, Robert:
Testimony.................................................... 100
Prepared statement........................................... 244
Hammonds, Timothy M.:
Testimony.................................................... 75
Prepared statement........................................... 188
Harkin, Hon. Tom:
Testimony.................................................... 47
Prepared statement........................................... 145
Hoglund, Richard J.:
Testimony.................................................... 11
Prepared statement........................................... 129
Kava, Ruth, Ph.D., R.D.:
Testimony.................................................... 99
Prepared statement........................................... 241
Kelly, Hon. Raymond W.,:
Testimony.................................................... 51
Prepared statement........................................... 147
Kennedy, Hon. Edward:
Testimony.................................................... 45
Prepared statement........................................... 144
Levinson, Richard, M.D.:
Testimony.................................................... 95
Prepared statement submitted by Mohammad N. Akhter, MD, MPH,
on behalf of the American Public Health Association........ 221
Mikulski, Hon. Barbara:
Testimony.................................................... 42
Prepared statement........................................... 142
Miller, Sanford A.:
Testimony.................................................... 57
Prepared statement........................................... 180
``Mr. Broker'':
Testimony.................................................... 27
Prepared statement........................................... 137
Nagle, Nancy, Ph.D.:
Testimony.................................................... 82
Prepared statement with an attached letter................... 210
Schultz, William B.:
Testimony.................................................... 55
Prepared statement........................................... 159
Zawel, Stacey A., Ph.D.:
Testimony.................................................... 77
Prepared statement........................................... 194
APPENDIX
Exhibit List for September 10, 1998 Hearing
* May be found in the files of the Subcommittee.
Page
1. GList submitted by the U.S. Customs Service of ``Highlighted
Investigations, Importation of Tainted Foodstuffs''............ 248
2. GGAO Report, FOOD SAFETY: Opportunities to Redirect Federal
Resources and Funds Can Enhance Effectiveness, August 1998,
GAO/RCED-98-224................................................ *
3. GMemoranda prepared by Don Mullinax, Chief Investigator,
Stephanie Smith, Ph.D, Investigator, and Mary Mitschow,
Counsel, Permanent Subcommittee on Investigations, dated
September 8, 1998, to the Permanent Subcommittee on
Investigations' Membership Liaisons, regarding ``PSI Hearing On
Fraud and Deception In The Food Imported Process''............. 253
Exhibit List for September 24 and 25, 1998 Hearing
1. GMemoranda prepared by Don Mullinax, Chief Investigator,
Stephanie Smith, Ph.D., Investigator, and Mary Mitschow,
Counsel, Permanent Subcommittee on Investigations, dated
September 22, 1998, to the Permanent Subcommittee on
Investigations' Membership Liaisons, regarding ``PSI Hearing--
Improving the Safety of Food Imports''......................... 265
2. GMemorandum from the American Law Division, Congressional
Research Service, Library of Congress, dated September 21,
1998, to the Permanent Subcommittee on Investigations regarding
``Safety of Imported Foods: Authority of the Food and Drug
Administration and U.S. Department of Agriculture, Food Safety
and Inspection Service''....................................... 319
3. GCRS Report to Congress, The Safety of Imported Foods: The
Federal Role and Issues Before Congress, October 14, 1998, by
Donna U. Vogt, Analyst in Social Sciences, Science, Technology,
and Medicine Division, Congressional Research Service, Library
of Congress.................................................... 339
4. GLetter from Food and Drug Administration, Department of
Health and Human Services, dated September 15, 1998, to The
Honorable Susan M. Collins, Chairman, Permanent Subcommittee on
Investigations, regarding Food and Drug Administration's (FDA)
analysis of FDA's regulatory and legal authority for imported
foods.......................................................... 379
5. GFood Safety From Farm To Table: A National Food-Safety
Initiative, A Report to the President, May 1997, prepared by
the U.S. Department of Agriculture, the Department of Health
and Human Services, and the Environmental Protection Agency.... 386
6. GStatement for the Record of the Guatemalan High Level
Commission For Food Safety, ``Berry Production in Guatemala and
the Model Plan of Excellence--MPE''............................ 441
7. GList of industry and consumer organizations invited to
provide written statements for the record and August 13, 1998
letter of invitation of the Permanent Subcommittee on
Investigations................................................. 445
8. GSubmission for the Record of the National Fisheries
Institute...................................................... 448
9. GSubmission for the Record of the National Restaurant
Association.................................................... 458
10. GSubmission for the Record of the Association of Food and
Drug Officials................................................. 461
11. GSubmission for the Record of American Council of Independent
Laboratories (Attachments to submission retained in the files
of the Subcommittee)........................................... 466
12. GSupplemental Questions and Answers for the Record of Raymond
W. Kelly, Commissioner, U.S. Customs Service................... 468
13. GSupplemental Questions and Answers for the Record of William
Schultz, Deputy Commissioner for Policy, Food and Drug
Administration (FDA)........................................... 470
14. GSupplemental Questions and Answers for the Record of Thomas
J. Billy, Administrator, Food Safety and Inspection Service
(FSIS), Department of Agriculture.............................. 474
15. GSupplemental Questions and Answers for the Record of Dr.
Sanford A. Miller, Committee to Ensure Safe Food From
Production to Consumption, National Academy of Sciences........ 476
16. GSupplemental Questions and Answers for the Record of Dr.
Richard Levinson, Associate Executive Director for Programs and
Policy, American Public Health Association..................... 481
THE SAFETY OF FOOD IMPORTS: FRAUD AND DECEPTION IN THE FOOD IMPORT
PROCESS--PART III
----------
THURSDAY, SEPTEMBER 10, 1998
U.S. Senate,
Permanent Subcommittee on Investigations,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 9:33 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Susan
Collins, Chairman of the Subcommittee, presiding.
Present: Senators Collins, Domenici, Levin, Lieberman, and
Durbin.
Staff Present: Timothy J. Shea, Chief Counsel/Staff
Director; Mary D. Robertson, Chief Clerk; Christopher A. Ford,
Senior Counsel; Mary G. Mitschow, Counsel; Don Mullinax, Chief
Investigator; Kirk E. Walder, Investigator; Stephanie Smith,
Investigator; Eric Eskew, Investigator (Detailee, HHS-IG);
Lindsey E. Ledwin, Staff Assistant; Pamela Marple, Minority
Chief Counsel; Brian Benczkowski (Senator Domenici), Michael
Loesch (Senator Cochran); Steve Abbott (Senator Collins); Pam
Muha (Senator Specter); Patricia Dody (Senator Cochran); Tyler
Wegmeyer (Senator Cochran); Chris Dockerty (Senator Thompson);
Linda Gustitus (Senator Levin); Nanci Langley (Senator Akaka);
Marianne Upton (Senator Durbin); Kevin Landy (Senator
Lieberman); Myla Edwards (Senator Levin); and Maureen Barry
(Senator Roth).
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Good morning. The Subcommittee will please
come to order.
Today, the Permanent Subcommittee on Investigations holds
its third in a series of hearings on the safety of imported
food. This morning, we will examine how fraud and deception in
the food import process can allow contaminated and dangerous
food into this country and onto the dinner tables of American
families.
At our first hearing in May, the General Accounting Office
reported on the current state of the food import system and
concluded that ``Federal agencies cannot ensure that the
growing volume of imported food is safe for consumers.'' The
GAO's findings represent a serious indictment of some Federal
efforts to ensure the safety of imported food and are
particularly critical of the Food and Drug Administration's
inspections system.
One of GAO's most disturbing findings, one of the findings
that we will focus on today, is that ``weaknesses in controls
over food imports enable entry of unsafe products'' into the
United States. In other words, even if Federal inspectors
discover contaminated food, effective controls are not in place
to prevent these unsafe products from entering the American
marketplace.
The GAO reported that the FDA's system for controlling the
importation of unsafe foods has a history of circumvention by
unscrupulous importers. At our May hearing, we heard briefly
about Operation Bad Apple, a recent Customs Service review of
import procedures at the Port of San Francisco. The bottom line
of that investigation is extremely troubling. Customs found
that 70 percent of the food shipments that the FDA had ordered
destroyed or reexported because they were unsafe actually
entered U.S. commerce. The fact that the FDA inspects fewer
than 2 percent of the 2.7 million shipments of food into the
United States each year is in itself a cause for concern, but
we now find that even if the FDA discovers contaminated food,
there is a good chance that this unsafe food will end up in
grocery stores and restaurants across America.
Serious deficiencies in the FDA's inspection system allow
some imported food--including contaminated and unsafe food--to
be sold in domestic commerce before the FDA inspects or
releases the shipments. In some cases, the importers simply
sell the food before FDA is able to inspect or release it. In
other cases, unscrupulous importers fail to reexport or destroy
the unsafe products after they have been rejected by the FDA.
The fact that the FDA does not take custody of suspect
shipments facilitates the evasion of its orders, according to
the GAO.
After hearing the testimony from the GAO at our May
hearing, I asked the agency, as well as the Subcommittee staff,
to dig deeper into the weaknesses of Federal controls over
shipments of imported food. I asked them to identify ways to
strengthen these controls.
In this regard, a key question that we will explore today
is whether existing penalties provide a meaningful and
sufficient deterrent or whether they are simply considered a
cost of doing business. This hearing will examine the specific
ways in which unscrupulous importers exploit weaknesses in the
current system to evade food safety protections and consider
possible options to improve controls over food imports.
Our focus is on the deficiencies in the current system that
allow fraud and deception to flourish. Fraud, as with criminal
activity in general, occurs when two elements converge, motive
and opportunity. Motive for criminal activity in most cases is
the age-old vice of greed. The Subcommittee's initial
investigation indicates that greater profit, the low risk of
apprehension, and insufficient penalties provide the motive for
unscrupulous importers to ship unsafe food into this country.
Opportunity with respect to fraud in the food import process is
the ability of unethical importers to exploit and evade the
inspection process.
When the current system gives criminals the opportunity to
evade import controls and bring tainted food into our country,
the impact is not merely monetary, as it is with most fraud-
related crimes. Here, the impact is far greater, affecting the
health and safety of Americans who consume imported food. And,
as we learned at our previous hearings, the very old, the very
young, and the very ill are most at risk for foodborne
illnesses that cause as many as 9,000 deaths in this country
each year.
To help us continue this important investigation, we will
hear this morning from officials of the GAO who will present
their findings from a review of import controls that I
requested following our overview hearing in May. We will also
hear from officials of the U.S. Customs Service, the first-line
agency responsible for the inspection and handling of imported
goods.
Finally, we will hear this morning from an individual who
operated on the inside of the food import business as a customs
broker. He was recently convicted during a Customs Service
criminal investigation and he has been cooperating with
authorities in a special operation that resulted in the arrest
and conviction of several individuals for importing unsafe
foods into the United States.
We look forward to hearing from our witnesses this morning
so that we can identify the weaknesses in import controls and
examine ways to close the loopholes used by unscrupulous
importers.
Americans enjoy having access to a wide variety of foods
from around the globe throughout the year. Our goal is to
ensure that America's food supply remains the safest in the
world and that the growing tide of imported food does not swamp
our already overburdened and ineffective food safety system.
It is now my pleasure to recognize Senator Levin for any
comments that he may wish to make.
OPENING STATEMENT OF SENATOR LEVIN
Senator Levin. Thank you, Madam Chairman, for conducting
this series of hearings on a very important subject. Your
leadership is critically important to the Nation and we commend
you for it.
Ensuring the safety of the Nation's food supply, both
domestic and imported, should be a top priority for Congress
and for the country.
We know that Americans are eating increasing amounts of
imported food, especially imported produce. Statistics
collected by the GAO reflect that Americans consume 50 percent
more imported vegetables today than they consumed in 1980.
These numbers reflect the increasing attention that we must pay
specifically to ensuring that imported food is safe for the
consuming American public.
We looked earlier at Federal food safety programs in
general. We learned that Federal inspection of imported foods
today is inadequate. Enforcement is understaffed. Remedies for
violations of the food safety laws are weak.
The strain on Federal food safety inspection resources is
obvious. In 1992, the FDA was able to inspect 8 percent of
imported foods, but in 1997, it was able to inspect less than 2
percent of imported foods. So our food safety inspection system
is being overwhelmed, both by the amount of imports and by
imports potentially contaminated with emerging pathogens, as
well, that are unfamiliar to our food safety agencies. So we
have got to update and strengthen the safety net for food that
Federal agencies are supposed to provide to our people.
The impact that one fraudulent actor, domestic or foreign,
can have on the lives of innocent U.S. consumers was
dramatically illustrated last year in Michigan when there was
an outbreak of Hepatitis A. A food brokerage company that was
based in California called Andrew and Williamson Sales Co.,
falsely certified to the U.S. Department of Agriculture that
certain strawberries that it had were domestic food products.
They did this knowing that the strawberries were grown in
Mexico and then, therefore, were not eligible to be sold to the
Federal School Lunch Program.
But those tainted frozen strawberries were served in a
school lunch program, and as a result, about 200 Michigan
school children contracted Hepatitis A. Andrews and Williamson
paid a $1.3 million civil penalty and about a third of a
million in criminal fines. That is an unusually severe one, and
appropriately severe. Too often, companies that do this are let
off with a slap on the wrist or very little penalty at all.
Today, we are going to examine a number of fraudulent
schemes that are perpetrated by food importers. These schemes,
according to the GAO, are more prevalent among importers who
bring into the country foods for which the FDA has
jurisdiction--fruit, vegetables, and seafood--than among
importers of meat and poultry, over which the Department of
Agriculture has jurisdiction.
Limited resources, lack of direct authority to control or
hold food shipments, and lack of effective deterrents seem to
be the real issues in the fight against food importer fraud.
Inspection personnel and resources are reduced while the
number of imported food shipments continue to increase. The
FDA, in contrast to the Federal Safety and Inspection Service
of the Department of Agriculture, has no legal authority to
require food importers to hold shipments in FDA-controlled
warehouses pending release approvals. That should change.
Finally, criminal remedies and bonding requirements,
largely are the only relevant legal remedies, have proven
totally ineffective, according to the GAO, because the
possibility of criminal prosecution is too remote or because
forfeited bond amounts are too insignificant to deter
unscrupulous importers. It just is too profitable at the moment
to engage in these schemes. We have got to take the profit out
of it. Hopefully, these hearings and this testimony will help
us take the profit out of fraud and out of the schemes which
endanger the health of the American public.
[The prepared statement of Senator Levin follows:]
PREPARED STATEMENT OF SENATOR LEVIN
Thank you, Madam Chairman, for conducting this series of hearings
on a very important topic of the safety of imported food. Ensuring the
safety of the Nation's food supply--both domestic and imported--should
be a top priority for Congress and for the country. In announcing the
establishment of a Council for Food Safety, President Clinton recently
said that we should all be committed to ensuring that the American
people enjoy the safest possible food.
We know that Americans are eating increasing amounts of imported
food, especially imported produce. Statistics collected by the GAO
reflect that Americans consume 50 percent more imported vegetables
today than they consumed in 1980. These numbers reflect the increasing
attention that we must pay specifically to ensuring that imported food
is safe for the consuming American public.
We started off this series of hearings by examining the Federal
food safety system generally. At the first hearing, we learned that
Federal inspection of imported foods today is inadequate: Enforcement
is understaffed and remedies for violations of the food safety laws are
weak. The strain on Federal food safety inspection resources is
apparent. In 1992, the FDA was able to inspect 8 percent of imported
foods, while in 1997, it was able to inspect less than 2 percent. Our
food safety inspection system is being overwhelmed by both the amount
of imports and by imports potentially contaminated with emerging
pathogens that are unfamiliar to our food safety agencies. It is clear
that the food safety net created by Federal agencies and existing
Federal statutes needs to be updated and strengthened.
Today we are examining instances of food importers--foreign or
domestic companies that bring food into the United States--purposefully
attempting to bypass U.S. food safety inspection laws. The direct
result of this conduct, of course, is to release food into the U.S.
food supply that has a significantly higher probability of being
tainted and of sickening U.S. consumers. These companies are profiting
at the expense of U.S. consumers.
The impact one fraudulent actor--domestic or foreign--can have on
the lives of innocent U.S. consumers was dramatically illustrated last
year when an outbreak of Hepatitis A in my home state of Michigan
occurred. A U.S. food brokerage company based in California called
Andrew and Williamson Sales Co., falsely certified to the U.S.
Department of Agriculture that certain strawberries it had were
domestic food products. Andrew and Williamson did this, knowing that
the strawberries were grown in Mexico and then, in order to sell the
frozen strawberries to the Federal school lunch program.
The tainted frozen strawberries were served in a school lunch
program and as a result, about 200 Michigan school children contracted
Hepatitis A. Andrew and Williamson paid a $1.3 million civil penalty
and $350,000 in criminal fines and restitution for its conduct. The
company was also debarred from selling to the U.S. Government for 3
years. Its president was recently sentenced to 5 months imprisonment
and 5 months home detention for his role in the affair, and paid a
$13,000 criminal fine. In trying aggressively to make a sale of food,
this company caused incalculable suffering for these Michigan victims.
Today, we are going to examine a number of fraudulent schemes
perpetrated by food importers. These schemes, according to the GAO, are
more prevalent among importers who bring into the country foods for
which the FDA has jurisdiction--fruit, vegetables, and seafood--than
among importers of meat and poultry, over which the Department of
Agriculture has jurisdiction. These importers, according to GAO, put
U.S. consumers' health at risk by engaging in such schemes as
substitution and port shopping. Some importers have come up with many
ways to try to beat the U.S. inspection system.
Limited resources, lack of direct authority to control or hold food
shipments, and lack of effective deterrents seem to be the real issues
in the fight against food importer fraud. Inspection personnel and
resources are reduced while the number of imported food shipments
continue to increase. The FDA--in contrast to the Federal Safety and
Inspection Service of the Department of Agriculture--has no legal
authority to require food importers to hold shipments in FDA-controlled
warehouses pending release approvals. Finally, criminal remedies and
bonding requirements, largely the only relevant legal remedies,
according to GAO have proven ineffective, because the possibility of
criminal prosecution is too remote or because forfeited bond amounts
are too insignificant to deter unscrupulous importers. It is profitable
for them to engage in these schemes.
The FDA should have the authority to hold food shipments and the
authority to select testing labs. We also need to strengthen the
penalties available for engaging in this type of fraud: We need to
increase bonding requirements or authorize civil penalties as well as
criminal penalties for this type of behavior. Further, we need to
provide food safety agencies, additional resources so that they can
carry out their inspection duties. I was pleased that Senator Harkin's
amendment in July to the Agriculture Appropriations bill which restored
funds to the FDA and Department of Agriculture for inspection
activities, as well as other food safety activities, was successful.
We cannot let it pay for food importers to beat the U.S. import
inspection system by fraudulent behavior at the expense of the
consuming American public.
I thank the witnesses for being here today and look forward to
hearing their testimony.
Senator Collins. Thank you very much, Senator Levin.
Senator Lieberman, welcome.
OPENING STATEMENT OF SENATOR LIEBERMAN
Senator Lieberman. Thank you, Madam Chair. Thank you for
holding another in this series of very important and, in the
first instance, just plain informative hearings examining the
safety of our imported foods.
I am going to keep my remarks brief this morning, but I do
want to emphasize how disturbed I was by the reading that I
have done of the materials our staff has prepared for this
hearing. At the last hearing in early July, we learned how an
undetectable parasite hidden in the folds of a raspberry can
cause an accidental outbreak of illnesses all across the
country. Today, in contrast, we will hear that shameless food
importers intentionally expose our population to dangerous
foodborne illnesses.
What kind of person, upon being informed that his shipment
of food was unhealthy for human consumption, that it was
rotting or already rotten or clearly contaminated with
salmonella, would nevertheless conspire to have it admitted
into our country, into our marketplace, and onto our dinner
tables? Obviously, one who has no personal scruples and,
therefore must be subject to the law.
The schemes that we will hear about today will leave no
doubt of these people's specific criminal intentions, nor of
their underlying and all too common motivation, which is
exactly what Senator Collins called it, greed, unlimited greed.
Why are we not treating these malefactors as criminals,
considering that their actions pose a genuine threat to public
health?
Well, as I read the record, in some cases, we are, but it
appears that the Federal Government has neither a system in
place nor the necessary resources to mount an effective defense
against the fraudulent importation of unsafe foods. The FDA,
for one, has clearly been overwhelmed as its responsibilities
have increased with the enormous increase in foods imported
into our country. I repeat the statistic that Senator Levin
mentioned. The FDA can physically inspect only 2 percent of the
imported food products for which it is responsible, which
obviously means, conversely, that almost all of the imported
food products which the FDA is charged with inspecting reach us
uninspected.
As the prepared testimony of today's witnesses
demonstrates, even when the FDA conducts inspections, an
importer wishing to evade the law can do so with the simplest
and crudest of Ponzi schemes. He can just keep one untainted
good shipment, which he presents to the FDA whenever the FDA
tries to examine other suspect food products, and the FDA
cannot tell the difference. Now, that is not much of an
inspection system to protect American consumers.
I was startled to learn in reading the materials for this
hearing, that an importer who is supposed to be disposing of
tainted food by shipping it out of the country under an order
to do so can instead substitute garbage for the rejected food
and release the food shipment into our markets with little or
no fear of detection. Or an importer can simply step up and pay
the small fines imposed by the law when he is caught as a cost
of doing business and then continue to release his harmful
products into the marketplace. This is an area where the law
seems toothless, and, therefore, food consumers are protection-
less.
I think the only reason why there is not more widespread
outrage at this is that there is not more widespread knowledge
of the current status of inspection. We actually have no idea
how many thousands of untraced cases of food poisoning are
caused by the legal loopholes that the system currently leaves
unfilled.
I thank you, Madam Chair, for playing a critical role here
in bringing these food health and safety problems to our
attention, and I also thank our witnesses for the work they
have done and for appearing today. I am looking forward to
their testimony. Thank you.
Senator Collins. Thank you very much, Senator Lieberman.
Senator Durbin, I would like to call upon you for any
comments you might have.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Thank you, Madam Chairman. I thank the
panel that has joined us today and I will be very brief.
I am happy that we are continuing this investigation into
the question of food safety, particularly in imported food. As
I have mentioned in previous meetings, it is a topic that I
have been focusing on now for about a dozen years, and I think
that the current system of inspection, as good as it is, can be
dramatically improved.
The testimony we are about to hear today is going to
suggest some unscrupulous and, frankly, illegal conduct on the
part of those who are exporting food to the United States. I
hope that we will not only be shocked by this, I hope we will
be moved by it to do something, to have more inspections, to
have better inspections, to have effective enforcement and
prosecution and real penalties.
I hope when this is all said and done that this Congress
will rise to the occasion and the Senate will lead in letting
the word go out across the world that as the United States is a
great opportunity for sales and a great marketplace, it is also
a country that is very serious about its standards and its
enforcement. We are going to protect the health of American
consumers. We are going to put the cops on the beat, as needed,
and we are going to enforce the laws stringently.
Thank you, Madam Chairman.
Senator Collins. Thank you, Senator Durbin.
I am pleased now to welcome our first panel of witnesses
this morning. The panel includes officials from the General
Accounting Office and the U.S. Customs Service. The GAO is
represented by Lawrence Dyckman, who is the Director of GAO's
Food and Agriculture Issues Division. Accompanying him are
Keith Oleson and Dennis Richards. I would like to compliment
the GAO for its excellent work in this area and for its
extensive cooperation with the Subcommittee.
I would also like to welcome our Customs Service officials
this morning. Mr. Richard Hoglund is the Deputy Assistant
Commissioner for the Office of Investigations. He is
accompanied by Mr. Philip Metzger, the Director of the Trade
Compliance Team. The Customs Service plays a critical role in
the enforcement of regulations concerning the importation of
food.
Pursuant to Rule 6 of the Subcommittee, all witnesses, as
those of you who have been here before know, are required to be
sworn in, so I would ask that you please stand and raise your
right hand.
Do you swear that the testimony you will give before the
Subcommittee will be the truth, the whole truth, and nothing
but the truth, so help you, God?
Mr. Dyckman. I do.
Mr. Oleson. I do.
Mr. Richards. I do.
Mr. Hoglund. I do.
Mr. Metzger. I do.
Senator Collins. Thank you. Mr. Dyckman, we are going to
start with you this morning. I understand that you are going to
be presenting the GAO's testimony and the two gentlemen
accompanying you will be available for questions.
TESTIMONY OF LAWRENCE J. DYCKMAN,\1\ DIRECTOR, FOOD AND
AGRICULTURE ISSUES, RESOURCES, COMMUNITY, AND ECONOMIC
DEVELOPMENT DIVISION, U.S. GENERAL ACCOUNTING OFFICE;
ACCOMPANIED BY KEITH OLESON, SAN FRANCISCO REGIONAL OFFICE,
U.S. GENERAL ACCOUNTING OFFICE; AND DENNIS RICHARDS, SAN
FRANCISCO REGIONAL OFFICE, U.S. GENERAL ACCOUNTING OFFICE
Mr. Dyckman. Thank you. Good morning, Madam Chairman and
Members of the Subcommittee. Mr. Oleson and Mr. Richards are
from our San Francisco Regional Office and they have spent
several years reviewing food safety issues. I am new to the
area, but I am very happy to be here today.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Dyckman appears in the Appendix
on page 109.
---------------------------------------------------------------------------
We are pleased to be here today to testify on Federal
agencies' efforts to prevent unsafe imported foods from
entering the U.S. market. With the number of imported food
shipments increasing, more than doubling over the past 6 years,
ensuring the safety of these imported foods becomes even more
challenging.
As we reported to you in May, we found weaknesses in
Federal agencies' controls over shipments of imported foods
that allow unsafe foods to enter domestic commerce. In response
to our earlier work, you asked us to obtain additional
information on the extent to which Federal controls ensure that
food importers present shipments for inspection when required
and that refused shipments entry are destroyed or reexported.
You also asked us to identify ways to strengthen these
controls.
In summary, FDA's current controls provide little assurance
that shipments targeted for inspection are actually inspected
or that shipments found to violate U.S. safety standards are
destroyed or reexported. Importers, rather than FDA, retain
custody over shipments throughout the import process. Thus,
some importers have been able to substitute products targeted
for inspection or for products that have been refused entry and
were to be reexported or destroyed.
Moreover, the U.S. Customs Service and FDA do not
effectively coordinate their efforts to ensure that importers
are notified that their refused shipments must be reexported or
destroyed.
Finally, Customs penalties for circumventing inspection and
disposal requirements provide little incentive for compliance
because they are too low in comparison with the value of the
imported products or they are not imposed at all.
As a result of these weaknesses, shipments that fail to
meet U.S. safety standards were distributed in domestic
commerce.
As I indicated, unscrupulous importers can bypass FDA
inspections. For example, in a San Francisco operation called
Shark Fin, Customs and FDA found that importers had diverted
trucks en route to inspection stations so that suspect products
could be substituted with acceptable products. According to
Customs investigators, the operations revealed that, among
other things, six importers were sharing the same acceptable
product when they had to present the shipment for inspection, a
practice known as banking, or as Senator Lieberman pointed out,
a Ponzi scheme.
In a follow-up operation called Operation Bad Apple,
Customs and FDA again found substitutions and other serious
problems.
Substitution problems occur after inspections, too, when
importers are ordered to redeliver refused shipment for
destruction or reexport. For example, during a 9-month period
in New York, Customs found discrepancies, including instances
of substitutions, in 31 of 105 refused shipments selectively
examined.
Several factors contribute to FDA's and Customs' problems
in ensuring that targeted shipments are actually inspected and
that refused entries are properly disposed of. First, unlike
FSIS, under FDA's legislative authority, importers are
generally allowed to maintain custody of the shipments
throughout the import process, thus providing importers with
the opportunity to circumvent controls.
Second, again, unlike FSIS, which is part of the U.S.
Department of Agriculture, imported food shipments under FDA's
jurisdiction are not required to contain unique identification
marks and FDA does not stamp products as ``refused entry''.
This is a basic internal control which is lacking.
Third, importers of FDA-regulated products are given 90
days to reexport or destroy refused entries, and again, this is
twice the amount of time the Department of Agriculture gives
its importers. Obviously, with 90 days, an unscrupulous
importer has more than enough opportunity to arrange for
substitution.
We also found that at five of the eight ports we examined,
Customs and FDA do not effectively coordinate their efforts to
ensure that importers are ordered to redeliver refused
shipments for disposal. For example, at two of these ports, Los
Angeles and New York, Customs was unaware of FDA refusals for
from 61 to 68 percent of the shipments we reviewed, and when
refused shipments are not properly disposed of, they are likely
to have entered domestic commerce.
For example, according to a New York Customs official, 48
of the 63 cases that we looked at did not have an FDA refused
notice and, therefore, were presumably released into commerce
because Customs did not issue a notice to the importer to
redeliver. In these cases, I might add, we found no
documentation in Customs files that these products were either
reexported or destroyed, which adds more credence to what
Customs officials told us. I might add that 11 of the 48 New
York cases and 8 of 21 similar cases in Los Angeles were
refused entry because they contained salmonella, a bacteria
that we all are aware of can cause serious illness.
Our review also showed that Customs penalties for failure
to redeliver refused shipments do not effectively deter
violations because they are either too low compared to the
value of the product or simply not imposed at all. In some
cases, Customs does not impose the maximum allowable penalty,
three times the declared value, because it exceeded the value
of the bond that the importer posted. In other cases, Customs
did not assess as severe a penalty as the agency guidelines
suggest because officials at these ports were unable to
identify repeat offenders and penalize them accordingly.
Customs and FDA officials and importer association
representatives suggested ways to strengthen controls over
imported foods as they moved throughout the import procedures.
Each of these suggestions has advantages and disadvantages. We
do not make any specific recommendations at this hearing, and I
will run through the suggestions, but I understand the
Subcommittee will be holding another hearing in a few weeks and
it might be a good opportunity to ask Customs and FDA and other
witnesses what they think of these suggestions.
First, for certain importers that have repeatedly violated
import controls, Customs and FDA could work together to ensure
that substitution does not occur before or after inspection.
For example, FDA could target problem importers and Customs
could order that importer's shipments be delivered by bonded
trucks to an independent Customs-approved bonded warehouse
pending inspection or disposal.
Second, Customs and FDA could adopt variations on the
controls that FSIS uses for meat and poultry imports. To help
prevent substitution before inspection, FDA could require that
shipments of importers or products with a history of violations
will have unique identification marks on each product container
and on entry documents filed with Customs. To help ensure
shipments refused entry are actually destroyed or reexported,
the FDA could stamp ``refused entry'' on each carton or
container in shipments that it does not find meet U.S. safety
requirements.
Third, Customs and FDA could develop a method of ensuring
that importers whose shipments are refused entry into the
United States are issued notices to redeliver their cargo. One
way for Customs to do this is to retrieve information from its
own database on FDA refusals.
Fourth, the Congress could reduce the 90-day period allowed
for redelivery of FDA-refused shipments to require importers to
dispose of refused shipments more quickly and more in line with
FSIS requirements.
Fifth, Customs could raise its penalties for repeat
violators to make them more effective deterrents, and my full
statement contains various ways in which Customs and FDA can do
that.
Madam Chairman and Members, this concludes my statement. We
will be happy to answer any questions you or other Members may
have.
Senator Collins. Thank you very much.
We will now hear from the Customs officials, and I believe
that, Mr. Hoglund, you are going to be presenting for the
Customs Service. Please proceed.
TESTIMONY OF RICHARD J. HOGLUND,\1\ DEPUTY ASSISTANT
COMMISSIONER, OFFICE OF INVESTIGATIONS, U.S. CUSTOMS SERVICE;
ACCOMPANIED BY PHILIP METZGER, OFFICE OF FIELD OPERATIONS, U.S.
CUSTOMS SERVICE
Mr. Hoglund. Good morning, Madam Chairman, Members of the
Subcommittee. Thank you very much. It is a pleasure to be here
today to speak about some of Customs investigative efforts in
recent years focusing on the illegal importation of tainted
foodstuffs. I am well aware of this Subcommittee's oversight
work in the area, including hearings held earlier this year.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Hoglund appears in the Appendix
on page 129.
---------------------------------------------------------------------------
While my statement will primarily highlight some recent
cases and the schemes uncovered, I thought it would be helpful
to the Subcommittee to give a brief overview of Customs'
mission, responsibilities, and challenges.
The U.S. Customs Service enforces more than 400 laws for
more than 40 U.S. agencies, including the Food and Drug
Administration and the USDA. In many cases, Customs has no or
very limited independent statutory or regulatory authority, but
instead derives the authority to prohibit importation,
exportation, or to seize merchandise from directions and orders
given by the regulating agencies. Indeed, Customs' work with
the FDA is very much like our work with the Departments of
State, Commerce, and Energy in the enforcement of U.S. export
laws governing weapons, technology, and nuclear items.
Customs faces what is perhaps the most diverse challenge of
any law enforcement agency in the world. Consider that the U.S.
Customs Service combats child pornography, narcotics smuggling,
money laundering, arms trafficking, stolen automobile exports,
theft from cargo, revenue fraud, intellectual property rights
violations, trafficking in endangered species, importations of
slave and forced child labor goods, and the importation of
tainted foodstuffs, to name just a few.
Combatting the importation of tainted foodstuffs presents a
unique situation in that actual smuggling or false invoicing at
time of entry is not necessary. Whereas a shipment of cocaine
must be sealed in a false compartment or within otherwise
legitimate merchandise, tainted foodstuffs can hide in plain
sight. That is to say, for the most part, where they are from
or what they are is not the issue as much as whether they are
clean or tainted.
Customs recognizes the threat that contaminated food
represents to our Nation. Indeed, public health and safety is a
priority area under our agency's trade enforcement strategy.
Customs has worked some 134 investigations related to tainted
foodstuff importation since September of 1993. I would like to
take a few minutes now to outline a few of these cases. Before
I do so, though, it is important to note that these cases rely
largely on the outstanding cooperative relationship between
FDA's investigative offices and the Customs Service.
Operation Shark Fin has been mentioned, and I will go into
a little bit of detail on that investigation. In April 1996,
the Special Agent in Charge, San Francisco Office, developed
information regarding the illegal importation and smuggling of
adulterated foodstuffs and the bribing of public officials.
Subsequently, in November 1996, a joint undercover
investigation was initiated with the FDA Office of Criminal
Investigations and the Department of Health and Human Services
Office of Inspector General. The ensuing 10-month investigation
disclosed that a licensed Customhouse Broker and two FDA
consumer safety inspectors had facilitated a scheme to allow
adulterated foodstuffs, such as real and imitation shark fins,
abalone, birds' nests, dried oysters, and scallops, to
illegally enter the commerce of the United States from Asia.
This is how it worked. In December 1996, Customs opened an
uncover brokerage business utilizing the Customhouse Broker as
a full-time employee. The storefront was used to monitor and
record illegal transactions between the broker and the targeted
individuals. The operation only focused on individuals with
whom the broker had conducted illegal transactions with in the
past. During the operation, there were more than 100 undercover
contacts with various targets.
During the undercover negotiations, several targets
expressed interest in offering monetary bribes to an FDA
employee in exchange for utilizing his or her position to sign
FDA entry notices containing fraudulent information. This
action would allow for the release of the FDA-regulated food
shipments without the required inspection by FDA. An undercover
agent posing as an FDA inspector was introduced to the targets
and the targets ultimately offered to bribe the undercover
agent in an attempt to circumvent Customs and FDA examinations.
This investigation determined that various schemes had been
used to get the illegal merchandise into the country. The
intent of these schemes was to circumvent inspection by Customs
and FDA. The importers would switch the contaminated
merchandise with clean merchandise--I believe that ``banking''
was referred to earlier--when an inspection was required. The
switch would occur between the time the cargo was moved from
the port where the vessel was docked and the location of the
warehouse for inspection. If samples for lab analysis were to
be taken at the importer's premises, the importer would have a
small quantity of this clean product available and would take
the samples from there to submit for testing.
In the event that merchandise was appropriately inspected,
tested, and found to be contaminated, the importer has the
option of reexporting the merchandise from the United States or
to destroy the merchandise. Should the importer elect to
reexport, the same merchandise would be imported back into the
United States at a later date. In the event that the importer
elected to destroy the merchandise, substituted merchandise
would be destroyed instead of the required merchandise. The
importer would usually destroy trash similar in weight to
merchandise they were supposed to destroy.
Operation Bad Apple was developed by the Office of Field
Operations of the Customs Service in San Francisco as an
outgrowth of Operation Shark Fin. Overall, this operation was
intended to measure the compliance with import requirements by
companies importing foodstuffs into the United States in the
Port of San Francisco and to take enforcement action against
willful and repeat violators. This operation was conducted with
the assistance and cooperation of the FDA during July 21, 1997
through August 4, 1997.
In order to examine imports of foodstuffs, selectivity
criteria were developed to notify the inspector electronically
of a foodstuff import. During Operation Bad Apple, 1,026
shipments of merchandise matched these criteria. Based on these
matches, 429 shipments containing 1,400 line items were
targeted for examination. The examinations resulted in a total
of 305 discrepancies discovered, and that is the entire array
of discrepancies. However, only a total of 33 shipments were
denied entry into the United States for not meeting FDA
requirements. In addition, 13 civil penalties were issued
against the importers, totaling approximately $200,000.
As a result of these operations, the Port of San Francisco
has identified the top 10 high-risk importers of foodstuffs.
These importers are being monitored closely for compliance with
FDA import requirements.
Another investigation was Sigma International. This was a
joint investigation conducted by the Special Agent in Charge,
Tampa, Florida office and the FDA Office of Criminal
Investigations. It was an investigation into a scheme by which
Sigma International, a large-scale importer, four of its
officers, and one of its foreign purchasing agents illegally
imported Indian-processed shrimp valued at approximately $4.5
million via false and fraudulent documents. These documents
were provided to the government in order to avoid compulsory
FDA laboratory testing, as well as examination of its
merchandise. The merchandise consisted of decomposed shrimp
that had been chemically treated to mask the decomposition.
The information uncovering the scheme was provided by an
FDA inspector after his review of entry documents and
examination of shrimp imported by Sigma. The company was
soaking the decomposed Chinese shrimp purchased in India in a
solution of chlorine and copper sulfate with the intent to
deceive customers by passing off the shrimp as fresh frozen.
Sigma sold its shrimp to large shrimp processors, who in turn
sold it to supermarkets and restaurant chains throughout the
United States.
The other investigation I would like to highlight is Fresh
Sea Products. In March 1996, a commercial truck entered the
Otay Mesa commercial inspection facility from Tijuana, Mexico.
The driver declared frozen fish products as products of Mexico.
Initial Customs inspection disclosed that the fish products
were really from the Orient. Further examination of the fish by
Customs and FDA inspectors revealed fish from shipments which
had been rejected entry into the United States by FDA 2 years
earlier, in 1994.
The FDA originally rejected the shipment because it
contained salmonella, botulism, and filth. This shipment was
exported and stored in Mexico and then attempted to be
reimported and sold to restaurants in the Los Angeles area. The
shipment was ultimately seized and ordered destroyed.
Currently, there are several ongoing investigations
involving the importation of tainted foodstuffs. Joint
investigations are being conducted with FDA and these
investigations include such schemes as the attempted
reimportation where entry had been denied, switching of
foodstuffs that were denied entry and were required to be
exported, and foodstuffs that were mislabeled to avoid
mandatory FDA inspection and testing.
I can assure the Subcommittee that this will continue to be
a priority area for Customs and that we will continue to work
with FDA to develop and execute effective investigative
operations targeting individuals and organizations involved in
tainted foodstuff importations.
Madam Chairman, that completes my prepared remarks. I would
be happy to answer questions, and, of course, you introduced
Mr. Metzger, who would assist in any areas that go specifically
to port processing. Thank you.
Senator Collins. Thank you very much, Mr. Hoglund.
Before we turn to questions, I want to welcome Senator
Domenici to these hearings and see if he has any preliminary
comments he would like to make. Senator Domenici, welcome.
OPENING STATEMENT OF SENATOR DOMENICI
Senator Domenici. Thank you very much, Madam Chairperson. I
have no remarks other than to, again, compliment you on these
hearings. When they first started, a lot of people wondered
what they were all about. They are beginning to understand,
thanks to your diligence and hard work, and I do hope we learn
something from it that we can implement. It is difficult to try
to find a better way to do it, but I think with your
leadership, we will find a better way and we will get it done
better. Thank you very much.
Senator Collins. Thank you, Senator Domenici.
I say that after these hearings, my diet gets more and more
constricted. First it was raspberries. Now it is fish, and
frozen shrimp, one of my favorites. On a serious note, it
really is disturbing to hear the testimony that we have
accumulated over the past two hearings.
I want to get a better feel for the extent that fraud and
deception contributes to the food safety problem in the United
States. Mr. Dyckman, I know that the GAO has done a lot of work
reviewing the shipments at the ports of entry, and it is my
understanding that you found substantial percentages in the
sampling that you did of rejected food products, food products
that have been rejected by the FDA, and keep in mind that the
FDA is looking at fewer than 2 percent of all the shipments.
But these are food shipments that have been rejected and yet
are finding their way into the American marketplace.
Could you give the Subcommittee some idea of how widespread
this problem is? Is it confined to one or two major ports or
did your review find that this was a problem at virtually every
port of entry?
Mr. Dyckman. Madam Chairman, as you indicated, it is
difficult to quantify the problem without doing special
operations at all ports all the time. But I have to tell you
that the internal control weaknesses that we observed, they
exist at every port. We have looked at controls of FDA-
regulated products at eight ports. We met with FDA beforehand.
We asked them if these were representative ports. They said
they were. So we have no reason to believe that the problems
that we identified and that Customs have identified through
special operations do not exist at just about every port.
You indicated, and I might add, that when Customs does a
special operation, they always uncover fraud and deception and
substitution. So my answer is, yes, these are pervasive
problems.
Senator Collins. And that suggests to me an indictment of
the system that we are using, that there are systemic
weaknesses that repeatedly allow unethical importers, that
allow criminals to evade the inspection process. Is that a fair
conclusion?
Mr. Dyckman. Yes. The internal control, or the control
problems that we identified, definitely give opportunities or
present opportunities for unscrupulous importers to bypass the
system.
Senator Collins. Mr. Hoglund, I want to talk further about
a specific case that you indicated because it seems so
egregious and shocking to me. As I understand it, you looked at
a case where fish in 1996 came in from Mexico and it turned out
that Customs inspection disclosed that the fish products that
were being inspected in 1996 were not from Mexico but were from
Asia and, in fact, that that fish came from shipments that had
been rejected by the FDA in 1994, 2 years before, is that
correct?
Mr. Hoglund. Yes, ma'am, that is correct.
Senator Collins. You indicated that in this case, the
company president pleaded guilty for the import of adulterated
food into the United States. Could you tell us what the
sentence and penalties were in this case?
Mr. Hoglund. I will look for that. I may have that handy.
Senator Collins. I think it is on page 7 of your prepared
testimony. It is my understanding that there was only a 1-year
probation and 50 hours of community service in this case. Can
you verify that?
Mr. Hoglund. The violator was sentenced to 1 year probation
and 50 hours of community service, that is correct.
Senator Collins. I am incredulous that that is all the
penalty was, that someone took 2-year-old fish that had been
rejected because it was contaminated with botulism, as I
understand it, is that correct?
Mr. Hoglund. Yes, that is correct.
Senator Collins. In other words, this fish could have
killed someone, or at the very least, made people extremely
ill. It was then held for 2 years, which certainly did not
improve the quality of the fish, reexported into the United
States, and the person who did this only got a year's probation
and 50 hours of community service? Do you think that that was
an adequate penalty?
Mr. Hoglund. Well, I can only assume that the sentencing
guidelines were followed by the judge in that case.
Senator Collins. I am not questioning that, and I am
certainly not blaming the Customs Service, which deserves
credit for bringing the case forward, but do you personally
believe that that was a sufficient penalty or should the laws
be far tougher? Do you think that is really a deterrent?
Mr. Hoglund. Well, I think it is the application, because,
as was stated earlier, there is a wide range and there are
violators who are sentenced to significant prison terms. So I
do not know that there is not the availability of significant
punishment. It is applying it.
Senator Collins. Mr. Oleson, do you have an opinion on this
case? Is it one that you are familiar with? I know you have
done a lot of work in this area.
Mr. Oleson. I am not specifically familiar with the case
mentioned, but I am somewhat incredulous, as you are, Senator,
that only a year probation and 50 years of community service
for bringing in a tainted product that had botulism, which is a
very serious contamination problem.
Senator Collins. It seems to me that one of the flaws that
our investigation has uncovered is that the penalties are
woefully inadequate to deter this kind of fraud that
jeopardizes the health and safety of American citizens. That is
really serious. That is not like substituting a lower quality
piece of jewelry for the one that was declared. I mean, it is a
serious problem.
Mr. Oleson, I want to turn to you now. It is my
understanding that you accompanied the Subcommittee staff in a
review of some warehouses, I think in California. Could you
tell us what you saw as part of your observations in that
review, please?
Mr. Oleson. Certainly. I did accompany the Subcommittee
staff on a couple of inspections. I think the most recent would
probably be the most illustrative.
We accompanied FDA to an inspection of a canned seafood
product. The FDA inspector entered the warehouse and asked the
warehouse operator or the importer where the shipment was
located. They directed him to a number of pallets that were in
the front entry of the warehouse, right by the front door, in
fact. The inspector then went on to select his samples and do
his inspection.
While he was doing that, we toured the warehouse and looked
at the other products that were in there and we found two other
shipments of this same canned seafood product. The markings on
the boxes were from the same manufacturer, the same information
was presented, and we could not determine why one shipment was
looked at over the other. They were virtually identical.
So we do not know if we were actually looking at the right
shipment when we got done, and I think that is the case where
substitution can take place. It could have been one of the
other shipments we were supposed to look at.
Senator Collins. If FDA just did the simple step of
stamping rejected shipments with ``refused entry,'' would that
not make banking and substitution a lot more difficult to pull
off?
Mr. Oleson. It would make it more difficult for products
that were refused entry and are being reexported, that it would
be more difficult to bring them back in or be easier for
Customs to determine that the actual refused shipment was being
sent out of the country. As we pointed out, in New York, they
have a special program where they examine exported shipments
that have been refused entry and 31 out of 105 times, they
found that the product was either short, missing altogether, or
was substituted with another product. That is a significant
problem.
Senator Collins. Another weakness that GAO's report has
uncovered is the fact that the importer retains control of the
suspect shipment. It is my understanding that that contrasts
with the system used by the Department of Agriculture, where
the shipment that has been targeted is taken into custody by
the Department of Agriculture. Mr. Oleson, is that correct, and
could you comment on the differences and whether you believe
the FDA's approach provides the opportunity for the kinds of
deception that we are talking about?
Mr. Oleson. Certainly. The Department of Agriculture, or
the Food Safety Inspection Service, has three major controls
that differ from the Food and Drug Administration. The first is
when a meat and poultry shipment comes into the country, it has
to be taken to an FSIS-approved inspection station. That is a
type of a bonded warehouse where it is controlled.
The shipment also must contain unique markings that are on
the health certificate that must accompany the shipment. So
when an FSIS inspector looks at the shipment, he can be assured
that this is one in the same shipment he is supposed to be
looking at.
The third area is when FSIS completes their inspection,
they will stamp any refused item ``refused entry''. It is still
controlled in that warehouse. It will not leave that warehouse
until either it is released by FSIS or the refused entry has
been taken care of by the importer, who has arranged for
export.
FDA does not have these controls. In fact, the importer
controls the shipment from the entire process, once it enters
until it is released. If it is refused entry, the shipment is
still at the importer's warehouse and it is up to the importer
to return it back to the port, where Customs will witness
either destruction or export.
There are no markings on the shipment to identify whether
they are the correct shipments or not. There is no stamp of
refusal, and as such, sometimes, as Customs pointed out, the
importers try to reimport the ``refused entry'' shipment. We
have two cases recently in Los Angeles where such things were
found. One was on rice sticks, the other was on a tamarind
fruit, where they brought them back in.
Senator Collins. Thank you, Mr. Oleson.
I am going to turn to my colleagues. I do have additional
questions, but I will wait for another round. Senator
Lieberman.
Senator Lieberman. Thanks, Madam Chair.
I wanted to thank you, Mr. Dyckman, and your staff at GAO.
I think you have done a first-rate investigative and reporting
job here. I must say that it leaves me with a feeling that this
is a very porous system. I do not underestimate the difficulty
of improving it and what it will cost us to do it. In that
regard, I appreciate some of your very thoughtful suggestions.
But it takes an honest and honorable importer to do it
right, because the probability of being able, at least as I
read your work, of being able to circumvent the system is high.
If you want to do it, it is pretty easy to game the system with
really dreadful consequences for a lot of people's health.
I just wanted to thank you for the work which you have
done, which is very important to us as we go about our work,
and I want to focus on a few parts of this.
One that struck me is what you point out are some serious
flaws in communication and coordination between the FDA and the
Customs Service. In what I consider to be a startling number of
cases that you pointed out in New York and Los Angeles, the
Customs Service was actually unaware of FDA's refusal notices
for food shipments. If I am not mistaken, it was between 61 and
68 percent of the shipments GAO reviewed, Customs was unaware
that FDA had put down a refusal notice.
According to your work, the GAO work, in most of the cases
where the Customs Service did not receive FDA's refusal notice,
the product would have been released into commerce here in this
country, and I gather from your report that in a number of
those cases, the products were refused by the FDA because they
contained salmonella. Have I got that right, Mr. Dyckman?
Mr. Dyckman. Yes, you have. Unfortunately, you do.
Senator Lieberman. Do you want to add anything to my
telling of it and explain--go ahead.
Mr. Dyckman. Well, yes. We have two agencies that have
unique responsibilities and they are supposed to work together.
We know that they are both hard-working agencies and they mean
well----
Senator Lieberman. Right.
Mr. Dyckman [continuing]. But there is obviously an
opportunity to improve their ability to detect these types of
things that we have been talking about. A basic principle is
that one agency knows what the other agency is doing, and
unfortunately, we found in too many cases that this is not
occurring.
We think the solutions are fairly simple. We have discussed
these with the agencies at closeout meetings. I think they are
both amenable to take corrective action to improve coordination
so that Customs knows in all cases when FDA refuses a shipment
so that it could send a notice of redelivery to the importer.
It is a basic internal control. We hope that, in short order,
it will be fixed.
Senator Lieberman. Mr. Hoglund or Mr. Metzger, do you want
to give a response to that, about why the Customs Service was
unaware of those FDA refusal notices at such a high percentage?
I mean, it is unsettling. We are talking about the basic
problem. The percentage of food that FDA gets to inspect is
relatively low. So even among that small universe, of those
where there are refusal notices, it seems as much as two-thirds
of the time, the notices are either not conveyed or for some
reason Customs is not aware of them, so the food may then go
out into commerce.
Mr. Metzger.
Mr. Metzger. The system as it works consists of two
automated systems. There is a Customs automated system and
there is an FDA automated system. Apparently, to date, the
systems have not talked to each other perhaps as they should
have. We have relied on manual notices or copies of those
refusal notices coming to Customs. Now, we are looking into why
these may not have gotten to us. However, notwithstanding that,
we believe that we need to work with FDA so that we get output
from the automated system, which has all of the refusals in it,
so that we can act on those and not rely on the manual
statements that we have been relying on to date.
As to why we did not receive them or did not get them, I do
not have the information. We certainly will look into that. But
I think we need to perfect the system, in any event.
Senator Lieberman. And you and FDA are working on that now?
Mr. Metzger. We certainly are.
Senator Lieberman. I hope you will keep the Committee
posted about progress on that as soon as possible.
Mr. Metzger. We will.
Senator Lieberman. Another part of this story that is hair
raising, or maybe I should say in this case stomach turning, is
the case that GAO makes that importers are able to bring
tainted food into the American market even after the FDA has
barred the import of food in another way, which is that
importers have the option of reexporting barred goods, but
there are cases that you cite where importers are actually
substituting shipments of garbage which they are reexporting.
Can you tell us a little bit more about that case, Mr. Dyckman,
or any of your team?
Mr. Oleson. Yes, Senator Lieberman. This is a predecessor
case to New York establishing their outbound inspection
program. What they are doing is they decided to examine some
shipments that were going out to determine--which Customs is
responsible for doing as the insurer--that the refused shipment
is either exported or destroyed. When they actually opened the
container, they found that there was garbage or trash in there
and not the shipment that was supposed to be. The weight was
right, but the product was not.
Subsequent to that, they had found----
Senator Lieberman. Excuse me. Therefore, the barred product
was presumably put into the marketplace?
Mr. Oleson. That is correct, that the barred product would
go ahead and be distributed to commerce.
Senator Lieberman. So have they set up a system now to try
to double-check that?
Mr. Oleson. Yes. In New York, they have what they call the
Outbound Program, where they will target certain shipments and
examine those intensively to determine whether there has been
any substitution or shortages or non-redeliveries. In fact,
they have a number of cases that they illustrated earlier where
they found them.
However, it is quite difficult to do that. Sometimes they
even had to call the manufacturer in the foreign country to
determine from the best-used-by date that was on the container
what the actual production date of that product was. After they
got that and they made their computation, they found that the
production date was subsequent to the importation date, so
obviously it was not the product that was refused entry, it was
another product. These are some of the things they are doing in
New York. It takes a very diligent, observant Customs inspector
to do that and we should praise him for his action.
Senator Lieberman. Do you know whether any criminal action
was taken against the importer who substituted trash for the
tainted food?
Mr. Dyckman. We are not aware of any.
Mr. Oleson. I suggest Customs may know that answer.
Senator Lieberman. Do you know, Mr. Hoglund or Mr. Metzger?
Mr. Metzger. I have no knowledge of that, but I will check
that out.
Mr. Hoglund. We can get the answer to you.
Senator Lieberman. I would appreciate that.
I have just one or two more questions. Mr. Hoglund, we have
heard that civil penalties are not an effective deterrent in
these cases because the amounts of the bond required by law can
be relatively small. Why does not the Customs Service pursue
criminal charges in a greater number of cases? I mean, you have
pointed out some cases here today which were successful and I
admire those, but why has not Customs gone through the criminal
courts in a greater number of cases?
Mr. Hoglund. Part of the answer is that we are dealing with
different sets of penalty regulations. The liquidated damages
which I think you are referring to in terms of the three times
the declared value, those are in line with enforcing FDA's
requirements for reexport or a violation of our redelivery
notice. We do have more significant civil penalties if a fraud
is committed on the Customs Service under our regulations and
under our laws. Likewise, the criminal penalties that have been
applied in the majority of these cases have had to do with
violations of Customs laws in terms of false invoicing,
misdescription, in order to evade the FDA requirement. So it is
a mixture, and I think Phil can explain more readily the area
of the liquidated damages.
Mr. Metzger. I would tell you that the Customs Service in a
large majority of cases where actions are initiated rely on the
civil penalty, the bond amounts. The maximum is three times the
value.
As far as pursuing criminal cases, and again, I do not want
to speak for the Office of Investigations, but it would seem to
me that it could be in part a resource issue. The criminal
cases require a number of investigative resources. It requires
a much higher level of proof, evidence, to sustain. We believe
that in most cases, the civil deterrent, the monetary penalty,
would suffice. Apparently, our assumption may not be correct
and----
Senator Lieberman. Would you agree, then, as we try to set
up a system--I mean, obviously, we cannot check and inspect
every piece of food coming into the country. As GAO has pointed
out, we can certainly do better than we are doing now in
various ways. But would not one of the ways to create better
behavior by these folks who are unscrupulous now be to have
more frequent enforcement of criminal penalties against those
who you find to be guilty of wrongdoing?
Mr. Metzger. What we hope to do with the FDA is target
likely violators, instead of just taking a broad-brush
approach, zero in on those areas where we think the risk is
highest, look at those more closely, and certainly, if we have
violators who are repeated violators, I think we would be
amenable to resorting to more of the criminal actions as
opposed to just the civil actions.
But again, we are going to work with FDA on zeroing in on
where the likely violations occur, that we cannot just use our
resources across the board and waste them. We know there are
areas where it is more likely that there will be violations and
that is where we hope to focus.
Senator Lieberman. I urge you to do that.
Mr. Hoglund, did you want to add something?
Mr. Hoglund. Yes. Senator, it might be helpful, of the 134
cases, investigations, that I mentioned earlier, 62 indictments
resulted from those, 47 arrests, 38 convictions, 7 court fines,
87 seizures, 17 penalties, 1 forfeiture, 3 acquittals, and 1
dismissal. Seventy cases were closed without any criminal
finding.
Senator Lieberman. Mr. Dyckman, just a final question. We
have talked about greed obviously being the motivation here.
Can you give us any idea of the amounts of money involved in
these shipments? I understand they are varying sizes, but I
have no idea of what kind of money can be made in this business
if one is willing to break the law.
Mr. Dyckman. Well, I think we have a case in our testimony
where the mark-up is substantial, so even if a penalty is
imposed at three times the declared value, there is still ample
room for profit. We were told by Customs officials that the
mark-up can be 10-fold, so----
Senator Lieberman. Ten-fold over the value of----
Mr. Dyckman. Of the declared value.
Senator Lieberman. Are these normally shipments that are
tens of thousands, hundreds of thousands, millions? I do not
know what the value is.
Mr. Dyckman. Do you have a better feel for the size of the
shipments that you looked at?
Mr. Richards. It varied widely.
Senator Lieberman. Maybe it is a hard question to answer,
because they vary widely, but the point you made is an
important one, particularly as related to the penalty system
because of the markup.
Mr. Dyckman. Yes. We visited warehouses and some of the
shipments are huge, more than one truckload. Depending on the
type of product, they could be very valuable.
Senator Lieberman. OK. Thanks very much. Thanks, Madam
Chair.
Senator Collins. Thank you, Senator Lieberman.
Senator Durbin.
Senator Durbin. Thank you, Madam Chairman.
Mr. Hoglund, for some perspective here, can you give me an
idea of how many inspectors the Customs Service has in this
area of imported food inspection?
Mr. Hoglund. I will defer to Mr. Metzger. That is his area.
Mr. Metzger. Well, the inspectors do not concentrate in one
area. We have inspectors who do cargo around the country, and I
would guess the number would be about--Customs inspectors,
now--about 2,500 inspectors who do cargo.
Senator Durbin. Can you give me an idea of the volume of
entries that they would inspect during the course of a year?
Mr. Metzger. The number of entries that come into the
country in the course of a year is around 18 million entries.
Of that number, I would estimate that the percentage examined
is less than 5 percent.
Senator Durbin. We had a hearing on this subject in May and
I asked Mr. Oleson some questions then. I will have to tell you
that I am disappointed in the GAO report, that it does not
address the question which I raised in the first hearing. I
believe that it is fundamentally unfair to compare the Food and
Drug Administration to the Food Safety Inspection Service of
the U.S. Department of Agriculture without making some
reference to the difference in staffing, which is dramatic. Mr.
Dyckman, are you aware of that difference?
Mr. Dyckman. Yes, I am.
Senator Durbin. Did you make any reference to that at all
in the GAO report?
Mr. Dyckman. Our report, or our testimony basically
addresses poor internal controls, what you do with the staff
that you have. In some cases, there are legislative problems.
The authorities that the Department of Agriculture has are
different than FDA's. USDA's are stronger. Staffing is part of
the issue. But even putting staffing aside, things like
marking, things like putting things in bonded warehouses,
should not directly impact the number of staff that Customs or
FDA has.
Senator Durbin. Mr. Dyckman, I do not argue with that, and
I think each of your suggestions is a good one and I think they
should be implemented and it should be a consistent standard,
whether it is the FSIS or FDA. There are some of us who feel
that this should all be under one agency, rather than spread
around 6 or 12 different Federal agencies with different
administrators and different rules and regulations and an
absolute crazy quilt of standards when the American consumer
just wants to know one basic question: Is this safe to eat? I
think we ought to get down to the bottom line.
But for the record, I want to put on the record what I
consider to be a dramatic quantitative difference between the
FSIS and the FDA which needs to be part of this record and
should be part of a GAO report. I really think it goes beyond
the question of improving the procedures here, but whether we
are prepared to make a commitment as a Nation to have the kind
of quality inspection that we need.
First, let us talk about the volume of growth. The number
of imported food products has doubled over the past 6 years. In
the Food and Drug Administration, each inspector is responsible
for nearly three times as many shipments today as they were 5
years ago. That is expected to increase by another 33 percent
over the next 5 years. U.S. News and World Report did a study
on this and they concluded the agency has a seemingly
impossible task.
Now, let me give you the figures. We have talked about the
fact the FSIS visually inspects 118,000 entries of imported
meats and poultry, and physically inspects 20 percent of them,
118,000 entries. How many inspectors are at the Food Safety
Inspection Service? Eighty-four.
Now, go over to the Food and Drug Administration. There are
2.7 million entries, as opposed to 118,000, of imported foods,
physically inspecting 1.7 percent of them, and they have,
according to Mr. Oleson's testimony in May, 463 people who are
involved in that. The USDA, Department of Agriculture, has only
4 percent of the responsibility of the Food and Drug
Administration. They have 84 inspectors, where the Food and
Drug Administration has 463.
If we were to put a comparable number of inspectors in the
Food and Drug Administration, based on the entries that are
inspected by the Department of Agriculture, we would have to
quadruple the number of inspectors in the Food and Drug
Administration, at which point those inspectors would have more
time to take a look at these shipments, more time to carefully
evaluate whether somebody is gaming the system, and more time
to try to determine whether or not they are dealing with the
banking and other problems that we have talked about today.
When I take a look at the situation facing the Customs
Service, with 2,500 inspectors, the largest of all of them, it
appears that they could always use more, but they have
substantially more resources, more personnel who are involved
in this.
Now, here is the bottom line and why we do not talk about
this on Capitol Hill. How are we going to get more inspectors
in the FDA? There are two ways. One, increase their
appropriation, which means spending more money here on Capitol
Hill. We do not like to talk about it in a time of reducing the
budget. But if we are going to be honest about it, we are going
to have to. The other alternative is a user fee, saying to the
people who want to export to the United States, you have got to
pay for inspection so that we can be certain that the American
consumers know that they are getting something safe on their
tables. Then we can talk about system changes, and I think all
of the system changes you have suggested are valid system
changes.
But when the system is so overwhelmed--here is what the
U.S. News and World Report said. ``Inspectors in the FDA
checking computer paper records''--they have gone to computers,
because they cannot keep up with the physical inspection--
``spend about 3 to 10 minutes on each shipment,'' and that is a
computer inspection. That is not a physical inspection. And
only 1.7 percent were actually inspected.
If we are going to be honest about this, and I hope we
will, let us change the system, as has been suggested by the
GAO, but let us also accept the responsibility to put men and
women on the job in these ports. The Food and Drug
Administration has 309 food safety inspectors. The others that
I mentioned, 463, are laboratory analysts and the like. There
are 330 ports of entry in the United States. There are fewer
inspectors than there are ports of entry. Why do we have a
problem? I would suggest that is part of it, Mr. Dyckman.
Mr. Dyckman. I do not disagree with anything you said,
Senator Durbin. As a matter of fact, yesterday, we issued a
report to the House Budget Committee that says many of the same
things you are saying. We point out that $1 billion is being
spent by the Federal Government on food safety inspections, but
we question whether 25 percent of that is actually targeted to
high-risk activities.
For example, the Department of Agriculture spends about a
quarter-of-a-billion dollars on carcass-by-carcass inspections,
looking at every carcass, and we question the risk posed to the
American people that could be eliminated by doing these
inspections and we suggest that possibly some of that money be
redirected for other things, such as solving the imported food
safety problem.
Senator Durbin. That is exactly the point I tried to get to
on consolidating this in one agency, and I would like your
response to that, because if we had all of the food safety
inspection under one agency, in legislation that I have
introduced, we could sit down with the National Academy of
Sciences or some recognized scientific organization and say,
all right, let us talk about real risk. Is it necessary to
inspect each beef carcass that comes in or would it be safer
for the American consumer for us to focus on processed products
or fruit and vegetables? What is the best investment of our
money for the safety of the American consumers? If you or Mr.
Hoglund would like to address this question of consolidating
food safety inspection in one agency, I would appreciate it.
Mr. Dyckman. We have been on record, as you probably know,
for many years supporting the concept and we have recommended
that the Congress consider creating one agency to handle food
safety in the United States. Currently, as has been pointed
out, it is a patchwork among 12 to 13 different agencies and
there is no one spokesperson. There is no one that is in charge
of the budgets for all these agencies as it deals with food
safety. The National Academy of Sciences just came out with a
report and it looks like they read many of our reports, because
some of the language looks very familiar to me as I have read
and prepared for this hearing. So we support in concept just
about everything you have said.
Senator Durbin. Thank you for your testimony, and let me
not take anything away from your recommendations. I think they
are all very valid. But I think we have got to get down to the
bottom line here. We can make changes, modifications in
procedures and they will undoubtedly marginally improve the
situation. But if we are serious about this and if we are truly
going to be a Nation more and more dependent on imported food,
I think we have to be serious about it and we have to go down
to some basic questions. Are we willing, first, to streamline
this and to make it more efficient with one agency, and second,
will we put the resources into inspection to make sure that we
can guarantee the American people that they have safe food on
their tables?
Thanks, Madam Chairman.
Senator Collins. Thank you, Senator Durbin.
For the next round of questions, I am going to ask the
lights be put on for 5 minutes per Senator for questions.
I do want to just quickly follow up on the points that
Senator Durbin has raised. Many of us recently voted for a
substantial increase in the food safety budget as part of the
agriculture appropriations bill, but I think what GAO is saying
is that as long as you have these weaknesses, as long as FDA,
for example, is not focusing its resources on the greatest
health risk, as long as importers are allowed to retain custody
of suspect shipments, as long as shipments are not stamped
``refused entry,'' as long as the importer has 90 days to deal
with the problem rather than the 45 days that FSIS gives its
shippers and importers to deal with rejected shipments, as long
as those flaws exist in the system, we can add all the
inspectors in the world and we are still going to have a
problem. Is that correct, Mr. Dyckman?
Mr. Dyckman. It is correct. Without good internal controls
to make sure that--for example, when a product is refused by
FDA, you could have, as you point out, as many inspectors as
you want, but there is no assurance that the product is the
same product that gets destroyed or reexported, you may not
have accomplished anything. So you could put a lot of money
into this problem and really not have substantial results. I
think it has to be a coordinated, comprehensive effort. We
agree that it is important to address the budgetary issues
involved with food safety, but it is just as important, as you
indicate, to address the internal controls. Right now, they are
weak.
Senator Collins. I do think we need more resources and I
supported the expenditure of $66 million as part of the
appropriations process, but I do not want to just put more
money into a broken system because more money and more
inspectors, if the system is still broken, if the flaws that
you have identified still exist, is not going to solve the
problem.
Let me turn to a specific in that regard. Mr. Dyckman, how
does the FDA's 90-day time period, which is twice the time
allotted for FSIS-regulated products, make it more likely that
unsafe food will be distributed in this country?
Mr. Dyckman. Well, it is pretty obvious that the more time
an importer has and the fact that the product is in his
custody, he has more time to arrange for illegal substitution.
Senator Collins. And it is my understanding that that is
statutory. So that is something Congress has to change, is that
correct?
Mr. Dyckman. That is correct.
Senator Collins. Mr. Metzger, do you see any reason, any
policy or technical reason, why the time period cannot be
reduced, especially considering that 75 percent of importers, I
understand, would not be affected by a shortened time for
redelivery?
Mr. Metzger. We have no problem with that, Senator.
Senator Collins. I would like to ask both Customs and the
GAO, why do we allow--and I believe Senator Lieberman touched
on this--why do we allow reexport of unsafe food? Why do we
want it to go anywhere in the world? Why do we not order it
destroyed? Mr. Oleson.
Mr. Oleson. Thank you, Senator. There are certain foods
that we will not allow reexport to. They are called Class I
violations, which such a thing as botulism is not supposed to
be reexported, but unfortunately, there are cases where it has
been.
The rationale provided to us by FDA is that some of these
foods, although they do not meet U.S. standards, can meet
foreign country standards or they may be able to recondition
them in the foreign country. For example, if you have a
salmonella-contaminated product, which is not a Class I
violation, they allow reexport. If you take that product and
cook it to a certain temperature, you will kill the salmonella
and then it may be acceptable to eat. So it is the rationale
that these products still could be reconditioned or used
elsewhere is why they do not require destruction.
Senator Collins. I do not think the consumer would be very
excited about reconditioned food.
Mr. Oleson. I cannot argue with that, either.
Mr. Dyckman. Particularly if it takes 2 years.
Senator Collins. Right. Mr. Hoglund.
Mr. Hoglund. It is obviously a reasonable question as to
why is it not destroyed, but I do not know the rationale in
terms of the legislation, why an option was provided, and I
also do not know if there are some commercial usages, that were
taken into consideration perhaps, a reexported product can be
somehow processed into some non-edible fertilizer or whatever.
Senator Collins. That might be a legitimate reason.
Mr. Hoglund. The reason for reexports. I do not know if the
commercial reason----
Senator Collins. That is the only one that I can think that
might be legitimate.
Mr. Richards, I did not want you to feel slighted. My final
question is for you. At an earlier Subcommittee hearing on food
safety, a former FDA inspector testified that the current
system of fines and penalties is nothing more than ``a slap on
the wrist.'' What did GAO's review find with regard to
importers' attitudes towards penalties? Did they see them as
just a cost of doing business or a serious deterrent, and what
kind of profits are we talking about here?
Mr. Richards. Well, at nearly every port we went to, the
Customs and FDA officials told us that from their experience,
the importers did consider these penalties for failure to
redeliver products as a cost of doing business. Regarding the
types of profits that can be made, as Mr. Dyckman mentioned, we
had heard in some cases that the difference between the
wholesale value of the product and the cost to the importer
could be as much as 10 times. That seemed consistent with what
we had reported to Congress in 1992, where we also had shown
some examples of differences where the wholesale value that the
importer could gain from a product exceeded the penalty that
was imposed for not destroying it or exporting it.
Senator Collins. Thank you for that information. That
suggests to me another area that we need to look at as we look
at the underlying laws in this area.
Senator Durbin.
Senator Durbin. No questions.
Senator Collins. Thank you. I want to thank the panel for
their cooperation. As was mentioned just briefly by Mr.
Dyckman, we are going to be turning to the remedy stage in our
next two hearings and we will welcome your suggestions and
input at that time, as well. Thank you very much.
Mr. Hoglund. Thank you.
Mr. Dyckman. Thank you.
Senator Collins. Our final witness this morning is a
confidential informant and former Customs broker. We will refer
to this witness today as ``Mr. Broker''. He will give the
Subcommittee an insider's view of how unscrupulous importers
use fraudulent and deceptive practices to circumvent food
safety inspections.
For the record, I want to note that the witness has
specifically requested that his face be obstructed from public
view because he is still cooperating with an ongoing Federal
criminal prosecution. Under the circumstances, the Subcommittee
has determined that this is a reasonable request. Without
objection, therefore, it is so ordered, pursuant to
Subcommittee Rule No. 11. I would note for the record that the
witness will testify behind an opaque screen and no cameras
will be permitted to photograph the witness from the area in
front of the screen.
Pursuant to Rule 6, all witnesses who testify before the
Subcommittee are required to be sworn, so at this time, I would
ask you remain seated, given the circumstances, but raise your
right hand.
Do you swear that the testimony you are about to give is
the truth, the whole truth, and nothing but the truth, so help
you, God?
Mr. Broker. I do.
Senator Collins. Thank you. ``Mr. Broker,'' you may proceed
with your testimony.
TESTIMONY OF ``MR. BROKER,''\1\ CONFIDENTIAL INFORMANT/FORMER
CUSTOMS BROKER
Mr. Broker. Madam Chairman and Members of the Subcommittee,
at your request, I am here today to testify about fraud and
deception in the food import process. Before I begin my
testimony, I would like to thank this Subcommittee for
respecting my request to keep my identity protected during this
hearing.
---------------------------------------------------------------------------
\1\ The prepared statement of ``Mr. Broker'' appears in the
Appendix on page 137.
---------------------------------------------------------------------------
Senator Collins. We will just ask you to speak right into
the microphone. They are a little bit sensitive, and we want to
make sure we can hear you. Thank you.
Mr. Broker. I retired in February 1998, after serving
almost 20 years as a Customs broker. As a broker, I was
responsible for expediting imported cargo through U.S. Customs
Service and other Federal agencies. I also assisted importers
with ocean, air, truck, and rail transportation, as well as
their insurance needs. In addition, I advised importers on the
many different agency requirements for their products and I
served several hundred clients with their shipments each month.
As you stated, Madam Chairman, I recently pleaded guilty in
Federal court in an ongoing Federal investigation and I am
scheduled to be sentenced later this month. Consequently, I
cannot discuss any details of the ongoing investigations in my
case.
I am appearing here voluntary in a sense of duty to correct
the mistakes of the past. Today, I will discuss some of the
various techniques used by problem importers to circumvent FDA
and U.S. Customs Service laws and regulations. In the interest
of time, I will summarize a written statement previously
submitted to this Subcommittee and will focus on the three
segments of food import process: Import shipments, refused
shipments, and penalties for violations of import regulations.
There are many ways in which the problem importer can avoid
food safety inspections and introduce unsafe food into this
country. An importer's main objective is to get their cargo to
their buyers as quickly as possible, and if they are importing
adulterated products, they want to avoid FDA and Customs
inspection procedures. They look for ports that have lax
examination procedures. Los Angeles--Long Beach and New York
are two ports with the largest inbound volume and are
considered the easiest ports of entry.
Importers and brokers know which ports have the weakest
import controls and this leads to port shopping. For example,
in the San Francisco area, the FDA inspectors are much tougher
than Customs, but in Los Angeles, the Customs inspectors are
much tougher than FDA. It is much easier to import adulterated
food through these ports just because of the volume.
Imported food shipments may be inspected by the Customs
Service, USDA, or FDA, and in some cases, all three agencies
may inspect the same product. Customs inspectors are authorized
to conduct either merchandise enforcement team, their MET
exams, or CET exams, contraband enforcement team exams. Because
these inspections by Customs are not focused on food safety, my
experience has shown that these exams do very little to prevent
adulterated food getting into the country.
When the FDA decides to inspect or sample imported food
products, it will normally take place at the importer's
premises. The importer is required to keep the product intact
from the time it leaves the port until the FDA approves the
release into U.S. commerce. Importers can take the products out
of the shipping container and place them in their warehouse,
but they are supposed to keep the products intact.
However, it is very easy for the importers to substitute
products before FDA inspectors arrive. In some cases, the
importer has from 2 to 4 weeks to prepare for FDA's arrival.
This allows the problem importers to sell adulterated products
and replace them with legal products from a subsequent
shipment, all before the FDA inspectors arrive.
Problem importers typically import large amounts of
products that will not pass FDA inspection because these have
the highest profit margin. In order to get these products
through FDA inspections, importers will use a banking system.
This is how banking is used to avoid inspection procedures and
import unsafe food into the country.
Importers will import some food items, referred to as
``double clean,'' that will pass FDA inspection and store these
items in their warehouses. When FDA arrives to inspect a
shipment, the importer will provide the clean products for
inspection. Once these pass inspection, the importer can reuse
these items for future FDA inspections. Depending on the shelf
life of the product, problem importers can use this scheme and
these same products for months or even several years.
The automatic detention procedures also present problem
importers with an opportunity to avoid food safety inspections.
If the FDA finds imported foods that are adulterated or
problematic, the FDA may place these products on automatic
detention. Many importers prefer to be on automatic detention
because they have control over the product. Importers prefer
automatic detention because of the lab reports that are coming
from private labs that are chosen by the importers rather than
FDA.
Importers can submit as many samples as they like to the
private labs for testing until they get a sample that will pass
FDA's approval. In some cases, importers actually select the
products to give the laboratory technicians for sampling. The
food products supplied by the importers may not even be from
the proper shipment.
When dealing with refused shipments, even when food
shipments are rejected and found to be adulterated, the current
system still allows importers to sell the unsafe food. Problem
importers, for example, may fill containers with trash or other
items, but not the adulterated food products that the FDA has
refused entry.
When the truck driver arrives to the destruction site, the
inspector may only weigh the container without examining the
contents of the container. The importers may stack a few boxes
of the refused product in the rear of the truck, thereby losing
only a fraction of the original product. There also are
importers who know the Customs inspectors very well and these
inspectors may just sign off on the destruction documents
without doing any verification.
In addition, there are no sanctions against importers if
they get caught destroying the wrong product. A truck driver
can always say that he made a mistake and picked up the wrong
cargo.
Customs has very few controls over the reexportation of
refused shipments. Importers may present Customs with different
products to be reexported than the products that were refused
entry. Importers also may export products, repack them, or try
to reimport them again. Importers may even try to reimport into
a different port.
The penalty system used by Customs and the FDA to sanction
problem importers when they try to bring unsafe food into the
country is ineffective. Most penalties imposed are just written
off as a cost of doing business. During my experience as a
Customs broker, penalties levied by the U.S. Customs Service
against problem importers do not serve as a deterrent for
attempting to bring adulterated products into the United
States.
In fact, virtually every time importers were sanctioned,
they were able to successfully get Customs to mitigate the
penalties. Importers often say it was a mistake in order to
deflect the blame of any violations or may go as far as having
false fire or police reports presented to Customs to show that
the products were either destroyed or stolen.
This concludes my statement and I will try to answer any
questions that you have.
Senator Collins. Thank you very much.
I know it is difficult to quantify the extent to which
fraud and deception contributes to the food safety problems
that we have in this country, but I want to ask you, based on
your 20 years of experience as a Customs broker, how often does
this happen, from your direct personal observations? Is it
something that happens once a month or once a week or is it a
common, everyday occurrence?
Mr. Broker. From a small group of importers, it is every
day, just every day.
Senator Collins. So this is a widespread problem. It occurs
in ports across the country and the ports, you seem to suggest,
with the most volume are particularly vulnerable and an
unscrupulous importer will port shop and try to hit a time when
the volume is high, is that correct?
Mr. Broker. That is very correct. Problem importers, they
look for the high-volume ports. You would not want to go to
Seattle, for example, where they have very little food imports.
You would want to go to Los Angeles or New York, where the
volume is so high and the inspections are so low that they
virtually just pass right through.
Senator Collins. You mentioned in your testimony, and this
is the first time I have heard this, that even when an importer
is caught and a preliminary penalty is assessed, that the
importer in virtually every case that you personally knew about
was able to get the penalty lessened, or mitigated. How is that
done? How do importers convince Customs to lower the penalty?
Mr. Broker. In many cases, they will submit documentation
that they have exported or destroyed the product. They have
said they made a mistake, any number of ways.
Senator Collins. But is there not even a term of art among
the importers called the ``big mistake'' letter?
Mr. Broker. Oh, yes. There is always the ``big mistake''
letter.
Senator Collins. Could you tell us, what is the ``big
mistake'' letter?
Mr. Broker. Well, they start off first, well, the supplier
sent me the wrong shipment, or I do not understand English, or
there----
Senator Collins. This is done often enough that
unscrupulous importers refer to it as the ``big mistake''
letter?
Mr. Broker. Oh, it is just the ``big mistake'' letter and
they just try to come up with any kind of idea they can. Many
times, they have so much experience with dealing with U.S.
Customs penalties, they find out which works one time and which
works another and they will just continue to use that
particular excuse at that time and then develop it for the next
penalty. And since there is no tracking or very little
tracking, I have seen probably over a dozen penalties that were
over $300,000 that they were able to mitigate down to $100.
Senator Collins. That is an important point that you made,
about the lack of tracking. So a lot of times, the inspectors
do not realize that there have been problems with the importer
over and over again, is that correct?
Mr. Broker. That is very correct. Many times, the importers
are tracked by company name only.
Senator Collins. Do the criminals in this business set up
different companies under different names to try to circumvent?
If they do get on what Customs referred to as the top 10 list,
do they create a new corporate entity so it is harder to track
them?
Mr. Broker. Many of these companies will have three or four
different names already in place. If one of these companies get
into trouble, they will just shut it down and continue with the
next company. I understand in Los Angeles, for about $500, you
can set up a company with anyone's name as a corporation and
just keep running.
Senator Collins. Do you know of any cases where importers
have been barred from the business as part of the penalties?
Mr. Broker. None.
Senator Collins. There was an issue that I meant to raise
with Customs officials, and I am going to follow up, but they
have developed this top 10 list of frequent violators. Why do
they not just bar them from being in the business? But to your
knowledge, that does not happen?
Mr. Broker. It does not happen. I think that one of the
deterrents might be they track with Social Security numbers of
the people who are actually owning these companies.
Senator Collins. One of the weaknesses that GAO has
identified for us this morning is that the importer retains
custody of the shipment of food that has been questioned by the
FDA. The importer selects the food to be tested by the
laboratory. The importer also selects the lab. There is a lot
of excess trust built into the system, it seems to me. Please
comment for us on how much you think that those weaknesses
contribute to the ability of an importer to evade an order by
the FDA to destroy or reexport the product.
Mr. Broker. I will say that the largest number of importers
are doing business correctly, but the small majority, they can
avoid it very easily. They love to go on automatic detention,
if they can.
Senator Collins. Explain what that is for us.
Mr. Broker. Well, if a food product--FDA finds a food
product, such as rice sticks, which was mentioned this morning,
it is automatic detention from Thailand because it is filthy
case after case after case. FDA does not want to spend their
resources running everything through their lab, so they have
set up a lab or the private lab system. The importer must prove
that its product is good to FDA.
Senator Collins. So let me understand this. In the case of,
for example, rice sticks, the FDA has determined that there
have been continuing problems with this product----
Mr. Broker. Correct.
Senator Collins [continuing]. So it is put on an automatic
watch list, essentially, an automatic detention list, and that
means that the importer is required to test every shipment?
Mr. Broker. Right, and present the lab report to FDA
stating that this product is good.
Senator Collins. And that is the key point, is it not,
that----
Mr. Broker. Exactly.
Senator Collins. You have got to depend on the honesty and
integrity of the importer.
Mr. Broker. Correct.
Senator Collins. Do you think it would help if the FDA
retained custody of the shipment and put them in a government-
bonded warehouse?
Mr. Broker. I think that is a very good idea, and have the
bonded trucker also move the cargo because right there is a
very large weakness in the system, because any trucker at all
can move that cargo at this point.
Senator Collins. Thank you.
Senator Durbin.
Senator Durbin. ``Mr. Broker,'' in your 20 years in the
industry, did you work with exporters from a variety of
different countries?
Mr. Broker. Yes.
Senator Durbin. Did you find that there was a prevalence of
fraud and deception from any particular region or country?
Mr. Broker. In my expertise, I primarily dealt with the
Orient, but I do know from other brokers throughout the country
that there are problems at every port with different groups.
Obviously, on the West Coast, we deal primarily with Asia.
Senator Durbin. Is there any particular country of origin
that you consider to be problematic?
Mr. Broker. In particular, China.
Senator Durbin. When it comes to your experience in this
area, can you recall any specific examples where you were
involved in shipments of adulterated food into the country? We
talked here for a moment or two about seafood shipments and the
like. Can you recall any in your experience?
Mr. Broker. Well, I have seen numerous types of things, one
being pickled fish that was fermented and decomposed, basically
being brought in as fish sauce. Fish sauce almost always just
gets a clean pass. If FDA comes in to inspect, fish sauce is
cheap enough to keep around as a bank to show any inspector.
Senator Durbin. So they bank the clean fish sauce and the
other adulterated product moves through?
Mr. Broker. Right. Shark fin is another example. Shark fin
can be valued anywhere from $20 a pound to $400 a pound,
depending on the condition and the species. I have seen it come
in as frozen skate, which is a fish, if it is frozen. If it is
dried, it can come in as just virtually anything.
Senator Durbin. One of the things that was suggested here
by the GAO was marking shipments. Is that practical? Can that
be done?
Mr. Broker. That can be done, and that will probably stop
quite a bit of the problem. But for problem importers, a carton
costs about $1.25 apiece and just marking the outside carton
will not deter some of these people who really want to get this
product onto the market.
Senator Durbin. So the challenge is how to mark the actual
food product itself, if we can.
Mr. Broker. That is right.
Senator Durbin. That may be quite a challenge. I am not
sure.
Mr. Broker. That is quite a challenge. I was trying to
think of ways that you could do that, and it would be very
difficult unless you used dye in the boxes or something.
Senator Durbin. Have you been party to any conversations
where these importers have talked about the fact that the cost
of doing business may include a fine or probation, which they
are willing to run that risk because of the profit involved?
Mr. Broker. Not specifically to the cost involved, but
mainly the group of the importers that I have worked with in
the past, they obviously do not like the penalties, but they
would much rather pay the penalty than not be able to make
their sale and get that product out on the market quickly.
Senator Durbin. In one of the previous hearings, we talked
about the complicity of employees of the Food and Drug
Administration and other Federal agencies in these schemes.
Based on your 20 years of experience, how prevalent is that?
How common is it?
Mr. Broker. U.S. Customs, I found to be outstanding.
Senator Durbin. In terms of----
Mr. Broker. In the inspectors being right on the ball and
not looking for any additional profits, personal gain.
Senator Durbin. Honest?
Mr. Broker. Very honest. FDA, I think I have seen so many
opportunities for them out there that that is where the problem
has been.
Senator Durbin. We talked earlier, I do not know if you
were here, when the panel testified about the number of
inspectors at FDA as opposed to some other Federal agencies. Is
this common knowledge, that the FDA inspectors have a larger
workload than some other agencies that are responsible for this
inspection?
Mr. Broker. Absolutely. If you have a problem shipment and
you try calling FDA to discuss it, you are very lucky to get a
phone call back because they are just overloaded, or trying to
get an inspector out. We have had releases--it is basically a
standard procedure that if a FDA inspector has been notified
and in 2 weeks he still has not been able to get to the
inspection site, they will release the cargo without
inspection.
Senator Durbin. One of the other things that was discussed
was whether or not there is sufficient inspection, for example,
that the Customs Service does get inside a box to determine
what the contents actually are as opposed to the manifest or
what is written on the outside of the box. What has been your
experience in that regard?
Mr. Broker. Well, Customs inspectors, taking, as an
example, the CET teams, they are looking for drugs. If it is
not a drug, they do not care. The box just moves. MET teams are
more thorough, but if the invoice says that it is noodles and a
MET team inspector goes up and looks at rice sticks and it says
noodles on the box and it looks like a noodle, it is a noodle.
Senator Durbin. So in terms of breaking open the package,
taking a close look at the contents, is that a rare occurrence?
Mr. Broker. It is a fairly rare occurrence.
Senator Durbin. Thank you very much for your testimony.
Senator Collins. Thank you very much. I want to thank you
for your testimony today and for providing assistance to the
Subcommittee staff as we attempt to get a handle on this.
I think perhaps the most shocking statement that you made
today was the fact that there was in one case a $300,000
penalty----
Mr. Broker. Several cases.
Senator Collins [continuing]. Several cases where that was
lowered, ended up being only a $100 fine.
Mr. Broker. Correct.
Senator Collins. I just wanted to make sure I heard that
correctly.
Mr. Broker. That is correct.
Senator Collins. Thank you very much for your
participation.
I would ask that everyone remain seated for just one moment
prior to my adjourning the hearing so that ``Mr. Broker'' may
exit the room. And again, I would remind any cameras, if there
are any here, to please refrain from taking any pictures while
the Capitol Hill Police escort the witness from the hearing
room.
Senator Collins. I want to thank Senator Durbin for his
participation in the hearing today. He has been a real leader
in the food safety area and I know we are going to continue to
work closely on this as we turn to the next stage of this
investigation.
Today's hearing, which focused on fraud and deception in
the food import process, highlighted a very disturbing problem,
and that is that unsafe food contaminated with dangerous
pathogens is distributed in this country, in part because of
weak import controls, poor coordination among Federal agencies,
and low penalties for violating food safety regulations. The
chances of the FDA catching contaminated products through
inspections at the border, we know is very low, given the low
number of inspections, but what is more disturbing to me is the
fact that even when a shipment has been detained, that it so
frequently makes its way into the American marketplace. That is
simply unacceptable and we have to have a better system in
place.
As I mentioned in my opening statement, this hearing is the
third in a series of hearings. We will now turn to the remedy
stage of the investigation process. We will hold 2 more days of
hearings on September 24 and 25. The first day will give
Members of Congress and Executive Branch officials the
opportunity to provide recommendations for improving our
Nation's food import system. On the second day, the
Subcommittee will hear from a wide variety of private sector
groups.
With that completion of our hearings, I look forward to
working in the next few months with my colleagues in the
Congress as well as the Executive Branch and the private sector
to develop some legislation to really address this issue.
Again, I want to thank all of our witnesses today for their
testimony. We will keep the hearing record open for an
additional 10 days in case Members have any additional
questions.
I also want to thank my very capable PSI staff for their
usual excellent job in this area.
The Subcommittee is now adjourned.
[Whereupon, at 11:25 a.m., the Subcommittee was adjourned.]
IMPROVING THE SAFETY OF FOOD IMPORTS--PART IV
----------
THURSDAY, SEPTEMBER 24, 1998
U.S. Senate,
Permanent Subcommittee on Investigations,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 10:06 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Susan M.
Collins, Chairman of the Subcommittee, presiding.
Present: Senators Collins, Levin, Lieberman, and Durbin.
Staff present: Timothy J. Shea, Chief Counsel/Staff
Director; Mary D. Robertson, Chief Clerk; Christopher A. Ford,
Senior Counsel; Mary G. Mitschow, Counsel, Don Mullinax, Chief
Investigator; Kirk E. Walder, Investigator, Stephanie A. Smith,
Investigator; Lindsey E. Ledwin, Staff Assistant; Pamela
Marple, Minority Chief Counsel; Beth Stein, Counsel to the
Minority; Brian Benczkowski (Senator Domenici); Michael Loesch
(Senator Cochran); Felicia Knight (Senator Collins); Nanci
Langley (Senator Akaka); Marianne Upton (Senator Durbin); Lynn
Kimmerly (Senator Cleland; Kevin Landy (Senator Lieberman);
Jeffrey Goff (Senator Cochran); Pam Maku (Senator Specter);
Tyler Wegmeyer (Senator Cochran); and Antigone Popamianos
(Senator Levin).
OPENING STATEMENT OF CHAIRMAN COLLINS
Senator Collins. The Subcommittee will please come to
order. Good morning. I want to apologize for the late start
today. We are unfortunately in the midst of a series of votes,
so we may have to come and go during this hearing, but we will
try to keep the recesses and interruptions as brief as
possible.
In June 1997, the Permanent Subcommittee on Investigations
began an in-depth investigation into the safety of imported
food, with particular focus on imported fruit and vegetables.
Over the last 14 months, Subcommittee investigators have
consulted with representatives from 27 industry, consumer, and
science-based organizations, as well as with officials from the
General Accounting Office and seven Executive Branch agencies.
We have reviewed, as part of our investigation, thousands of
pages of documents, conducted in-depth interviews with 25
experts, and heard testimony presented by 13 witnesses at three
previous Subcommittee hearings.
Our prior hearings have covered a great deal of ground. In
our first hearing we discussed the findings of a General
Accounting Office study examining the prevalence of foodborne
illnesses and exposing serious deficiencies in Federal efforts
to ensure the safety of imported food. In our second hearing we
undertook a case study of dangerous microorganisms carried into
the United States on imported fruit--raspberries from
Guatemala. In our third hearing we examined how weak controls
exploited by unscrupulous importers can completely undermine
the food safety net that is intended to protect American
consumers.
These issues are literally life-and-death matters for many
Americans. As we learned at our previous hearings, the very
old, the very young, and the very ill are most at risk for
foodborne illnesses that cause as many as 9,000 deaths each
year in our country.
In today's global economy, we import a huge volume of food
from all over the world. In 1996, for example, we imported some
$7.2 billion worth of fruit and vegetables alone from at least
90 different countries. Most of this food, I want to emphasize,
is perfectly safe and provides Americans with an enriched diet
and the year-round variety that we enjoy. But far too often,
contaminated products, from domestic as well as imported
sources, reach the tables of American families, causing more
than 80 million cases of foodborne illnesses each year.
This investigation has revealed much about the food we
import into this country and how our government attempts to
protect Americans from unsafe food. Over the course of the past
several months, we have learned that Americans are eating more
and more food produced in foreign nations. Shipments of
imported food have doubled over the past 5 years, and that
amount will only continue to grow.
Foodborne illnesses have a significant impact on public
health as well as a substantial economic impact. Maintaining
the food safety net for imported food is an increasingly
complex task, made more complicated by previously unknown
foodborne pathogens like Cyclospora.
Since contamination of imported food can occur at many
different places from the farm to the table, the ability to
trace back outbreaks of foodborne illnesses to the source of
contamination is a complex process that requires a coordinated
effort among the Federal Government, State agencies, and local
agencies.
Because some imported food can be contaminated by organisms
that cannot be detected by visual inspection or laboratory
tests, placing additional Federal inspectors at ports of entry
alone is not sufficient to protect Americans from unsafe food
imports.
Federal agencies have not effectively targeted their
resources on imported foods posing the greatest risks. In the
words of the GAO, Federal efforts are ``inconsistent and
unreliable.'' Weaknesses in FDA import controls, specifically
the ability of importers to control the food shipments from the
port to the point of distribution, allow unsafe food to enter
the American marketplace.
The civil penalties imposed on importers who violate food
safety regulations are so low that they are often considered as
simply a cost of doing business. And, finally, the enforcement
of existing criminal laws provides little deterrence for
unscrupulous importers.
These are some of the Subcommittee's preliminary findings,
based on our hearings and investigation to date. Today, based
on these and related findings, we will take the next step in
our investigation by hearing recommendations from a wide range
of witnesses on how we can correct the flaws in the current
system, which I have just enumerated, and what changes need to
be made in Federal practices, regulations and laws.
My goals are to help ensure that food safety programs are
effectively managed; that existing resources are focused on
those imports posing the greatest risk of harm to Americans,
and that deficiencies in the underlying regulations and laws
are remedied.
Ensuring the safety of food imported into the United
States, we have learned, is a very difficult and complex task.
Countries have different food production and handling
practices, regulations and standards. Different regions of the
world also have different indigenous microorganisms and other
pathogens to which the local population--but often not American
consumers--may be immune.
As long as food imports continue to grow, these variations
will continue to have a significant impact on the safety of our
food imports. Moreover, new threats are developing all the
time. Some harmful organisms, such as Cyclospora, cannot be
detected through visual inspections or even through lab tests,
and they have emerged as dangerous to Americans only within the
past few years.
A mosaic of Federal laws and regulations, including at
least 35 Federal statutes, govern this process. In addition,
each of our 50 States has its own food safety and inspection
system, making an important contribution to the Nation's food
safety net.
Today and tomorrow, our hearings will focus on how the
Congress, the administration, State and local authorities, and
the private sector can work together to strengthen our food
import system. As we consider granting new authority and
allocating new resources, we must be sure that current laws are
vigorously enforced and that existing resources are efficiently
spent. More money alone will not fix a broken system.
We will hear today from two panels of witnesses, foremost
among them my colleagues Senator Paul Coverdell of Georgia,
Senator Barbara Mikulski of Maryland, and Senator Ted Kennedy
of Massachusetts. Each of these Senators has a strong interest
in food safety issues, and I look forward to hearing their
testimony and recommendations. I also suspect that each of them
is still on the floor voting, but we may be having them join us
shortly. I also see from the witness table that Senator Harkin,
who has been a leader in this area, is also expected to join us
this morning.
Our second panel of witnesses includes senior Federal
officials from the primary Executive Branch agencies with
responsibility for the safety of imported food, including
representatives of the FDA, the Customs Service, and the Food
Safety and Inspection Service of the Department of Agriculture.
They will be joined by a member of the Food Safety Committee of
the National Academy of Sciences.
We look forward to hearing from all of our witnesses today,
and to exploring ways to improve our food safety system. I
would note that tomorrow's hearing will feature witnesses
representing industry and consumer groups, and a wide variety
of organizations will be represented.
It is my understanding from the staff that Senator Kennedy
is on his way, so we will just be in recess for a few moments
awaiting the appearance of my colleagues.
[Recess.]
Senator Collins. We have now been joined by the
distinguished Senator from Connecticut, and I will call upon
him for any opening comments that he might have.
OPENING STATEMENT OF SENATOR LIEBERMAN
Senator Lieberman. Well, thanks, Sue, very much. Madam
Chairman, I am very pleased that once again you have put
together an excellent hearing with a very good group of
witnesses. I gather that we may hear at some point from our
colleagues, whose spirits are with us, so in absentia we will
thank them for their dedication to this important issue, the
safety of our food supply.
In addition to the Senators testifying today, two of our
colleagues on the Subcommittee have also introduced legislation
relating to food safety. Although all of these bills, I think,
take different approaches, they do not take contradictory
approaches, and I think they are all constructive pieces of
legislation that we will want to consider.
The safety of our food supply is an issue which should
unite everyone in this country and even in this legislative
body of ours. Our common enemies here are unseen pathogens
which can strike thousands of Americans and make them ill.
There are unscrupulous importers, enemies of ours, who
knowingly risk grievous harm to others for an easy buck. And,
finally, the common enemy we have here is our own failure to be
vigilant.
I think that the hearings that you have organized and have
presided over, Madam Chair, have contributed substantially on
each of these fronts, and now to our understanding that there
is a real problem out there that affects the well-being, the
health of millions of our fellow Americans, indeed of our own
families, and now it is time to move to solutions. You will
allow me, I hope, the pun of saying notwithstanding what we
have learned previously, I am hungering for solutions.
And I look forward in that spirit to the testimony of our
witnesses today, and thank you again for your leadership.
Senator Collins. Thanks very much, Senator. I see that we
have begun yet another vote. I suspect that the Senators who
will be testifying will wait and vote first, so I am going to
do likewise, so we will suspend the hearing for about 10
minutes.
[Recess.]
Senator Collins. The Subcommittee will be in order.
We are very honored this morning to have a distinguished
group of our Senate colleagues with us. They each have a keen
interest and much expertise in the area of food safety.
We are going to begin with the distinguished Senator from
Georgia, Paul Coverdell, who is the Chairman of the Agriculture
Subcommittee on Marketing, Inspection and Product Promotion. He
is a leader in the Senate on issues related to food safety and
imports, and earlier this year introduced his own legislation,
which innovatively increases and targets food safety research
and education programs. If you would, please proceed, Senator.
TESTIMONY OF HON. PAUL COVERDELL, A U.S. SENATOR FROM THE STATE
OF GEORGIA
Senator Coverdell. Thank you, Madam Chairman. I am most
pleased to have the opportunity to testify before the Permanent
Subcommittee on Investigations to discuss this issue of great
importance, food safety. I would like to thank Senator Collins
for holding these hearings on the safety of imported food and
bringing this issue the proper attention it deserves, and I am
pleased to be here today with my colleagues, Senators Kennedy
and Mikulski.
This is an issue in which I have taken special interest as
Chairman of the Senate Agriculture Subcommittee with
jurisdiction over food safety issues, and as Foreign Relations
Subcommittee Chairman for the Western Hemisphere. I have long
been interested in maintaining our high standards of food
safety while we have become increasingly active with our
hemispheric trading partners, particularly in fruit and
vegetables. With this growth in imports, I have advocated a
commensurate growth in resources necessary to understand and
address the challenges we face in maintaining our food safety
standards.
The public is also becoming concerned with the safety of
their food. Over the past year there have been increased
reports of foodborne illnesses. GAO reported in May 1996 up to
81 million cases of foodborne illnesses, what we just talked
about, Madam Chairman, and 9,100 deaths occur each year in the
United States, and this is certainly cause for concern. I
believe that we should take a thoughtful, well-researched
approach to addressing the problem.
There have been well-publicized cases of food safety
problems, to be sure. Recently both children and adults became
ill with Hepatitis A from contaminated strawberries distributed
to schools through the USDA school lunch program. There was an
outbreak of E. coli 0157H7 which prompted the massive Hudson
beef recall, and recent problems with this same pathogen in my
State, where over 20 school children were stricken and
hospitalized with this deadly ailment. We have seen problems in
products as diverse as ground beef and apple juice.
I believe that protecting our Nation's food supply should
be a high priority for Congress and this administration. We can
do better, and we will, if we set the right course. With
technology advancing at lightning pace, there is no excuse not
to develop and significantly improve our food safety for the
21st century.
This is one area where food producers may be ahead of the
processors, albeit with their government regulators, in
technology, but this can certainly be changed with the proper
focus. We are increasingly becoming a global economy.
Agricultural trade is on the rise and is of permanent economic
importance to American agricultural producers.
This places more emphasis, of course, on our hemispheric
trade of perishables such as fruit and vegetables. Farmers in
foreign countries, particularly in Central and South America,
can harvest, pack and ship to the United States in short order,
with their products sometimes on the grocery shelves as quickly
as 24 hours later.
These new food supply options have been of great benefit to
consumers in the country, allowing a wider availability of
products throughout the year. I would imagine that the
Chairman's constituents are often the beneficiaries of these
new suppliers in times where domestic products just aren't
available.
So these systems are very important to our food supply, but
they are not without new challenges of food safety. These
challenges have prompted various legislative responses. All, I
believe, are well-intentioned. There are proposals currently
being considered which give Federal agencies, specifically for
today's business, the Food and Drug Administration, FDA,
additional regulatory authority in erecting more barriers
before foods can be imported into the United States.
I believe we should be cautious and thoughtful before
enacting such legislation because it will likely have complex
ramifications without proof that it will actually improve food
safety. I am not opposed to this approach, but I do think there
are many questions to be answered before granting such broad
authority to FDA.
Before we do this for any agency, we need to ensure that
the current systems in place are actually working and that we
are not overlooking obvious holes in them. I was extremely
concerned with how our Federal agencies are operating after
reviewing the April 1998 General Accounting Office report
entitled ``Food Safety: Federal Efforts to Ensure the Safety of
Imported Foods Are Inconsistent and Unreliable.''
The GAO report stated that the Food and Drug
Administration's procedures for ensuring that unsafe imported
foods do not reach U.S. consumers are vulnerable to abuse by
unscrupulous importers. This type of abuse must be stopped.
There needs to be a system in place which guarantees when the
FDA discovers imported contaminated food, it is either
reexported or destroyed in a timely fashion.
In addition, the GAO report found that the Food Safety and
Inspection Service and the Food and Drug Administration are not
deploying their inspection resources to maximum advantage. The
GAO report also showed problems with importers port-shopping,
and the FDA's inability to properly control the selection of
the samples tested by private laboratories or to certify
acceptable private laboratories.
These are just a handful of the problems cited by the GAO
which Congress and this administration need to address. From my
own experience, I saw produce sit on the tarmac at Miami
Airport for hours before being inspected, I might add, at
horrendous temperatures. This can't be good for the produce or
the consumer.
Further, I saw the sheer volume of products coming to the
United States from other nations, and quickly recognized that
technology was the key to this food safety. Simple manpower,
while helpful, will not fully address our food safety needs. We
need more advanced and scientific solutions to these problems.
There have been positive steps taken by the FDA in this regard.
They have often acted professionally and constructively in
working with other nations to address food safety problems.
My personal experience has been with the Guatemala
raspberry project. The FDA and Center for Disease Control and
Prevention have done an excellent job in working with the
Guatemalan Government and the Guatemala Berry Commission to
develop what will likely be a food safety model for other
nations in the hemisphere. Upon CDC's realization of the
problems with Cyclospora associated with Guatemalan
raspberries, they joined the Guatemalan producers and the FDA
in working tirelessly to develop a safer system of production.
The result was the model plan of excellence. This plan was
designed in an effort to mitigate all potential hazards in the
production of these raspberries, and is based on our Hazard
Analysis Critical Control Point system. It has undergone the
highest level of scrutiny by the Guatemalan Government and the
FDA, and is expected to be a breakthrough system for the
raspberry industry and potentially others like it.
I have personally toured a farm that qualifies under the
model plan of excellence, and I must say that I was most
impressed by its level of sophistication and by the dedication
of those producers working to develop it. Impressive also was
the commitment to food safety of those industry and government
officials I met in Guatemala. It was encouraging to see that
our government agencies could pay such an active role in
addressing, at its root, not a problem affecting a multitude of
consumers.
I will not belabor the model plan of excellence, which I
hope will be a successful program for the advancement of food
safety, but I do hope that the Chairman will have an
opportunity, either through an inquiry or testimony, to hear
more about this unique project from the Food Marketing
Institute, who I understand has been instrumental in working
with the growers and FDA in its development.
My point in mentioning this project in Guatemala is to show
that cooperation can exist between parties interested in
improving food safety, and it is going to be necessary for this
to occur if we want to better understand the complexities of
the new food sources. I must say, as an aside, that even to the
level of the President of the country there was a commitment to
engage this issue and resolve it.
In summary, I believe that we need to place a greater
emphasis on food safety consumer education, research, and
prevention efforts in order to maintain our safe food supply.
It is highly unlikely that Federal agencies can ever ensure
that foods are 100 percent safe for consumers, so it is
important for consumers to be well-prepared and educated on how
to prevent potential risk in their food supply.
Earlier this year I introduced a comprehensive food safety
proposal, the Food Research, Education, Safety and Health Act
of 1998, S. 2025, also known as the FRESH Act, which will
provide additional tools necessary to improve our overall food
safety. This legislation focuses on consumer education,
research and prevention efforts.
It authorizes consumer education block grants to the
States; establishes a Food Safety Council in which the
administration seems to be interested with their recent
announcement to establish such a group; promotes risk
assessments for animals, fruit and vegetables; and encourages a
variety of other activities which I feel are aimed at improving
food safety. In deference to the Chairman's time and intent
this morning, I will not discuss the food safety bill, but will
look forward to working with Members of the Subcommittee and of
this panel to develop a proper food safety initiative.
I do hope that some of my comments and experiences have
been helpful in outlining the approach that I would like to see
Congress take--studied and targeted. I look forward to
reviewing Senator Mikulski's proposal and continuing to work
with the Chairman and her staff on this most important issue.
Again, Madam Chairman, thank you for allowing me to testify and
for your leadership on this issue.
Senator Collins. Thank you very much, Senator, for sharing
with us your extensive experience and insights into this area.
I know that we are running behind schedule, so if any of the
Senators before us have to leave, we will submit questions for
the record.\1\
---------------------------------------------------------------------------
\1\ Questions for the record appear in the Appendix on pages 466-
482.
---------------------------------------------------------------------------
Senator Coverdell. Thank you.
Senator Collins. I am now very pleased to call upon my New
England neighbor, Senator Kennedy, who is the Ranking Democrat
on the Committee on Labor and Human Resources, which has
jurisdiction over many of the food safety issues. Senator
Kennedy, welcome.
Senator Kennedy. Well, thank you very much, Madam Chairman.
Since the principal sponsor of the legislation, which I am
interested in, is co-sponsored by my friend and mutual
colleague, Senator Mikulski, I would be glad to yield. And then
if she possibly leaves out one possible point, which I doubt
that she will, I will just make a very brief comment and then
submit my full statement. But perhaps we could recognize her
first, and then I will make a brief comment after.
Senator Collins. I would be happy to.
Senator Mikulski, it is a great honor to welcome you to the
Committee. I know you have had a longstanding interest in this
area and have been a real leader, and I have enjoyed our
discussions on this issue, and look forward to working with you
and hearing your testimony.
TESTIMONY OF HON. BARBARA MIKULSKI,\2\ A U.S. SENATOR FROM THE
STATE OF MARYLAND
Senator Mikulski. Well, thank you very much, Senator
Collins, and in the interest of time, because I know we got a
late start as well, I would like to ask unanimous consent that
my entire statement be placed in the record.
---------------------------------------------------------------------------
\2\ The prepared statement of Senator Mikulski appears in the
Appendix on page 142.
---------------------------------------------------------------------------
Senator Collins. It will be.
Senator Mikulski. And I am very delighted to be here with
you and Senator Lieberman this morning, and would like to
congratulate the Permanent Subcommittee on Investigations for
looking into this issue.
Far too often the American people have been scared because
they pick up the paper and read about yet one more outbreak of
foodborne illness: The killer raspberry, the suspicious
cantaloupe, the juice that was unpasteurized that resulted in
severe illness in children. And what we need to do is not only
manage the panic and manage the fear, but do that by coming up
with really sensible solutions.
I believe your previous hearings have really laid the
groundwork on what the nature of the problem is, in taking it
out of headlines and bringing it into Congress to look at how
we can protect the public health of the American people. I
congratulate you on this, and in my own way, working with
Senator Kennedy, have tried to come up with, again, a sensible
solution.
We agree what our principles are that every person should
have confidence that their food is fit to eat. We also need to
be confident that imported food is as safe as food produced in
the United States of America.
We also recognize that our food supply has gone global, so
we need to have global food safety, yet recognizing the
national sovereignty of other nations. The statistics speak for
themselves. We know that now over 40 percent of our food,
particularly in fruit and vegetables, is imported. Farm produce
that crosses our borders also must be safe.
Now, we have rules on imported products where we guarantee
safety. Cars can't be imported to the United States unless they
meet safety requirements. Prescription drugs can't come into
the United States of America unless they meet FDA regulations.
So you shouldn't be able to import food that isn't up to U.S.
standards, either, because those safety standards are
absolutely crucial.
You could go your whole life and never drive a car. You
might only take a prescription drug for emergency situations.
Yet you eat food every single day, which is why we need to be
both vigilant and effective.
We can go over those problems, and I know Senator Coverdell
and others have indicated what they were: The imported
strawberries that infected Michigan children with Hepatitis A;
the whole issue around vegetables and juices that resulted in
these illnesses. I know you have documented that as many as 81
million Americans become ill each year and over 9,000 die as a
result of food-related illnesses.
Now, some are problems in our own country, where people
don't follow the basic practices of public health, personal
hygiene, and basic sanitation. But at the same time, what is
now happening is that, because of the all-year-round growing
cycle around the world, more and more food is coming into this
country.
What is the FDA doing? Well, their system has been
documented by GAO and by their own declaration, is they do it
at the dock, looking at individual shipments. Well, colleagues,
you can't ensure our food safety one raspberry at a time, and
that is essentially what it is: One dock, one pier, one port,
one raspberry at a time. So we need to look for other
solutions.
I have been fortunate enough to be able to be in the State
of Maryland where we have the Johns Hopkins School of Public
Health, and they have instilled in me the concept of public
health. What is public health? One, epidemiology; know where
the problems are; go to the root cause. So if you treat
malaria, you don't do it by slapping it on your arm; you go to
the swamp. Also, the issue is prevention. Look at the systemic
issues and then deal with it.
Our food safety bill, that is sponsored by Senator Kennedy
and me really follows a public health model. What it does is
give the FDA authority to ban imported food from the United
States if it was grown or handled under unsanitary conditions
that do not meet the same as U.S. level of protection. The bill
allows the FDA to ban foods from places that deny the FDA the
right to inspect their production processes, and the Secretary
of Health would develop the plan for the implementation.
What this bill actually does is improve the imported food
processes of the FDA, and it aims at preventing foodborne
illness of all imported food. It places emphasis on the
underlying food system at the food source, which is ultimately
a more preventive way of addressing it. By allowing FDA to
consider a nation's food safety system and make recommendations
in compliance with our rules and World Health Organization
practices, we can deal with this.
There are several things that I want to be careful that we
know it does not do. It does not violate any nation's
sovereignty. That is not our business. It does not shut our
borders or immediately deny food entry. It doesn't require
inspections or access without consent of a nation. In fact, it
doesn't create any of those new inspection authority.
But it does enable the FDA to evaluate, working with the
other nations, what their food supply is. What this bill will
do is really significant. It will provide FDA with a more
effective enforcement tool, the ability to use its resources
more effectively, and also, by looking at what we can do with
other countries--like the Guatemala situation, the way Senator
Coverdell just talked about his work with them--particularly
Latin American and Central American countries.
We will not only--by looking at the systemic issues,
bringing to bear and encouraging public health practices in
compliance with their own standards and World Health
Organization basic public health recommendations--ensure the
safety of our food supply, but we will help a nation upgrade
its food supply for its own internal consumption. I think
that's pretty good because this is working with other nations
and being able to do this. And if these steps are not taken,
then the penalty will be that they can't bring their food to
the United States of America.
Let me conclude by saying this: Yesterday the Labor and
Human Resources Committee voted to approve Dr. Jane Henney's
nomination as FDA Commissioner. Hopefully the Senate will
confirm Dr. Henney and we will have a permanent Commissioner of
FDA.
Over 4 years ago I joined with another member of your
party, Senator Nancy Kassebaum, and we embarked upon a historic
effort, which was to modernize our FDA in terms of its
pharmaceutical drugs. We sought then something called the
sensible center, where we pulled together the best ideas and
the best practices, checked our party hats at the door, and
worked in the national interest. America is better off because
of that effort, and it is one of my proudest accomplishments.
I look forward to doing the same thing with you, to be able
to work now; if we can't get a hearing this time before we
adjourn, and action, that between now and the time we
reconvene, perhaps Members of your Subcommittee and we could
meet with you and Dr. Henney, get a framework, and hopefully
that by the beginning of the next session we will be able to
introduce legislation that represents the sensible center,
protects Americans' food supply, recognizes that we want a cash
crop coming from overseas. I would rather have raspberries than
some of the other stuff they are being exporting to this
country. And we will really help their own country and help
them, as well.
Thank you.
Senator Collins. Thank you very much, Senator. Don't take
this as a political endorsement, but I do very much look
forward to working with you on legislation that we can
introduce in the next Congress.
Senator Mikulski. Oh, I won't take it as a political
endorsement, but I hope others will. [Laughter.]
Senator Collins. Thank you.
Senator Kennedy.
TESTIMONY OF HON. EDWARD KENNEDY,\1\ A U.S. SENATOR FROM THE
STATE OF MASSACHUSETTS
Senator Kennedy. Thank you, Madam Chair, and I would like
to submit my statement in the record.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Kennedy appears in the
Appendix on page 144.
---------------------------------------------------------------------------
I want to thank you, Madam Chair, for the good work that
you have been doing and this Subcommittee has been doing to try
and make our food supply safer. I think it has been enormously
important, and many of us have been following the hearings that
you have had.
I commend you for the range of witnesses that you have
today and tomorrow. You really have lucked out to get the best
in the country. I know we have got many behind us here who can
speak with enormous competency about this issue, so I will be
very brief.
I want to acknowledge the leadership of my friend and
colleague Senator Mikulski on this issue, with the introduction
of the legislation and her constant pursuit of a safer food
supply.
My friend Senator Harkin, who has been really an
outstanding leader, was the offeror of the amendment which is
in the conference now in terms of increasing food safety
funding, so that we are going to be able to take immediate
steps prior to the time that we leave this year, to make sure
that we are going to bring the resources at the FDA to a more
legitimate level to provide for the kinds of protection
Americans expect. I know he will outline the reasons for that,
as we all heard him on the floor convincingly, and the
overwhelming vote, bipartisan, to try and give the kinds of
resources to the President's Food Safety initiative.
We are all mindful of the additional kinds of challenges
that we have given to the FDA in recent times. We have given
them not only the new legislation of last year. We have given
them increased responsibilities in terms of food safety. We
gave them natural food legislation, many other different
responsibilities, without giving them additional kinds of
resources, so they have been very pressed in recent times.
But I would suggest, as has been mentioned here, that we
are seeing the dramatic increase in imports that all of us
understand because of the changed kind of eating habits that
have taken place here in the United States. At the same time,
we must also note the fact, as Senator Mikulski has pointed
out, that we are only inspecting a very, very small, 1.7 or
less than 2 percent of all the products that come here.
But let me just give special urgency to not only the GAO
report but the Center for Disease Control report. It really
puts into perspective the fact that we are not just talking
about the quantity that is coming in--but it also is the change
in these foodborne diseases which are coming in. For half of
the illnesses and sicknesses from foodborne diseases, we don't
even know their cause.
We have seen these dramatic changes that are taking place
in terms of the food that is coming into these United States,
that is providing a very significant and important public
health risk. So it isn't just the flow line in terms of the
amount and the changed kind of interest of the American
consumer, but it is the various products themselves that are
coming in here, into a population that is changing, that is
becoming more vulnerable to some of these foodborne diseases.
Populations are coming here to the United States, are coming
from different kinds of societies that have different kinds of
challenges that are related to the various pathogens
themselves.
The resistance of various bacteria to some of the
prescription drugs we have is a matter of enormous importance.
In many respects, this hearing, I think, and this legislation,
are of monumental importance. All American families assume that
when they go to that supermarket, it is going to be safe and
secure for themselves, and particularly for their children.
I think we are at the cusp of a very, very important and, I
think, dangerous period, where we are going to have to make
sure, if we are going to insist that our food supply is going
to be the safest, that we are going to take certain kinds of
steps at the beginning. Senator Coverdell has got some ideas,
but I basically believe that what we have to do is go back and
look, give the FDA the authority, as Senator Mikulski has
outlined, to work with other countries to ensure that they have
adequate systems in place.
It is in the countries' interest. It may take some time
before they believe it, but after they get that stamp of
approval, it is going to expand their opportunities for
marketing. And it is also really in the interest of the United
States. I will just end with this.
I know that there are certain interest groups that want to
resist this approach--for a variety of different reasons that
you will hear about. But the fact is, when they get bad
strawberries that come from Guatemala, people stop eating
strawberries in Massachusetts. If they get bad raspberries,
people stop eating them. If they know that these are going to
have the good stamp of approval, the opportunity for expansion
of trade for these countries, I think, expands dramatically. We
have figures and statistics that demonstrate it. I won't get
into that, but I think it is pretty self-evident.
So I would hope as you go through, Madam Chair, that you
will give particular emphasis to the kinds of recommendations
and the kind of concerns that are reflected in the Center for
Disease Control's report, because I think that they have
outlined the real serious challenge that we are going to be
facing for a safe food supply. I believe that the legislation
that Senator Mikulski and others have supported, that I know
that you are interested in and reviewing carefully, will at
least give us the opportunity to make a very, very important
contribution in giving the American families the assurances of
a safe food supply.
And I thank the Chair.
Senator Collins. Thank you very much, Senator Kennedy. We
very much appreciate your taking the time to appear this
morning.
I am now pleased to call on Senator Tom Harkin. Senator
Harkin has been very helpful to this Subcommittee on a wide
variety of issues. I think you testified at the very first
hearing that I held on Medicare fraud. And I am pleased to
welcome you today in your position as Ranking Minority Member
of the Senate Agriculture Committee, and as a Member of the
Appropriations Committee. You may proceed, Senator.
TESTIMONY OF HON. TOM HARKIN,\1\ A U.S. SENATOR FROM THE STATE
OF IOWA
Senator Harkin. Thank you, Madam Chair. I am beginning to
feel like a regular at this Subcommittee, a witness or
something like that.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Harkin appears in the
Appendix on page 145.
---------------------------------------------------------------------------
But I do applaud you because you are using your
Subcommittee to look into areas in your investigative role, and
to bring to light concerns that affect people around this
country, and I applaud you for that, Madam Chair. You are doing
a really good job with this Subcommittee in a variety of areas,
and this is just another one where as I heard Senator Kennedy,
Senator Mikulski, and Senator Coverdell say before I got here,
this is a tremendously growing concern among the American
populace.
I share with you a poll that came out in the Des Moines
Register just 2 days ago, and the headline is ``Food Safety Is
Consumers' Top Concern.'' Listen to this:
``When asked to rate the importance of food safety as a
public issue, 89 percent of the consumers surveyed rated it as
very important,'' and it beat out crime prevention at 82
percent. They are more concerned about the safety of food than
they were about crime now.
Well, they have read the stories. Last year we had the
largest recall of ground beef in our history. In June we had 12
outbreaks from contaminated food, one of those being an E. coli
0157H7 outbreak. One person died of that, that we know of. And
so people are getting very, very concerned about the safety of
their foods.
So I commend you for having this hearing, and bringing this
to the attention of the public and of the Senate. I might just
point out that this is the only Subcommittee that has had a
hearing on this issue. The Agriculture Committee has not. The
Labor Subcommittee on Health has not. We have over a dozen
bills pending in the Senate right now on the food safety issue,
and this is the only Subcommittee that has had a hearing on it.
So I commend you, Madam Chair, for doing this.
I would say that I have been involved in this area for a
long time in terms of meat and poultry inspections, and how we
ensure the safety of our meat supply in this country. Last year
I introduced a bill, S. 1264, called the Food Safety
Enforcement Enhancement Act. It gives the Secretary of
Agriculture more authority, both to recall and to levy civil
fines.
Some in the industry have said we don't need that right
now. They will recall voluntarily. Right now, if there is an
outbreak, the Secretary has no authority to recall. He doesn't
have it. Now voluntarily the companies can do it, but the
Secretary can't, and I just want to give him that authority to
recall contaminated meat any time he finds it.
The second provision is to impose civil fines. The industry
says, ``Well, the Secretary can already close down a plant,''
shut it down. As Secretary Glickman said, that is the ``atom
bomb'' approach. There ought to be something less than that,
because if you shut down a plant, you put workers out of work,
and they may not have been responsible for the problem in the
first place.
Sometimes under the new HACCP procedures that we have now,
a problem could have been inadvertent, but you need to levy a
civil fine so that it sends a signal to others to clean up
their act. If we can have civil fines levied if you mistreat a
circus animal, if you can levy a fine for violation of the
Pecan Promotion Act, but the Secretary cannot levy a fine if
you produce contaminated meat, that just doesn't make sense. So
hopefully we can get something done on this to give the
Secretary a little bit more authority.
Senator Kennedy mentioned the Food Safety Initiative
funding on the ag appropriations bill, the amendment we got
through. The Senate vote was 65 to 34. The administration had
asked for $96 million. We were able to restore $66 million.
Because of PAYGO, we had to find offsets for it. We did find
for offsets $66 million for the food safety initiative of this
administration.
That funding is in conference right now, and I would like
to be able to sit here today and tell you it is all secure, but
I am not certain about that. So I ask all of you on both sides
of the aisle, if you have any contacts in the House, to please
reach across to the other side on the ag appropriations
conference and ask them to hold that $66 million that we have
for the food safety initiative. It is two-thirds of what the
administration asked for, but I just hope that we can keep it.
And I am not certain that we can, but we will fight for it.
Last, Madam Chair, I share with you your concern over fresh
fruit and vegetables. As others have said and as you know, more
and more people are eating more fresh fruit and vegetables
because of increasing imports. We can have fresh raspberries in
the middle of the winter, and strawberries, as Senator Kennedy
spoke about.
We really have been lax in setting up a regime to ensure
the cleanliness and the lack of contaminants on the fresh fruit
and vegetables that come into this country. I don't know that I
have an ironclad answer for you, but I do believe that two
elements must be involved here.
First, the FDA has to be given more authority in this area.
As you know, FDA has implemented standards for dairy and canned
foods. That was some time ago. They recently mandated a new
HACCP system for seafood. They are now working towards similar
systems for juices and sprouts. And, they are working with
industry for some voluntary guidelines for other types of
produce.
Now, these guidelines are voluntary. They are not quite all
we need, but at least they are moving in the right direction,
and we need to figure out how we can give FDA the same kind of
authority for fruit and the vegetables, especially those that
come into this country, as we are hoping that the Secretary of
Agriculture would have in meat and poultry products.
When I talk to consumers, while the polls all indicate that
there is a great concern about meat because that has been in
the news and because of the recall last year, I am finding more
and more people concerned about the produce they buy and where
it comes from, and whether it is clean and healthy and
wholesome. So we need to set up a regime to have imported
produce meet certain guidelines for cleanliness and for lack of
contamination as we do for our own that are grown in this
country.
Last, on the CDC, I just met with the new director of the
Center for Disease Control and Prevention yesterday--I think he
is taking over in about a week--and again, we need to figure
out how we give more authority. I talked to him specifically
about this. He said, ``What do you have on your mind?'' I said,
``Food safety.''
And CDC has done a good job. They do a really good job in
tracking things down. If there is an outbreak, they can track
it. They are pretty darn good at that. What they need to be
involved in more is prevention, and what they can do to prevent
contaminants from entering foods in the first place.
Again, I don't have an ironclad answer for you, but I look
forward to working with you, Madam Chair, and other Members of
the Subcommittee, to increase both the authority and power of
the FDA, but also to give more guidance and direction to the
CDC for getting up front and helping us with preventive
measures on imported fruit and vegetables.
Thank you, Madam Chair.
Senator Collins. Thank you very much, Senator Harkin, for
your contribution to this Subcommittee investigation, as well
as many others.
Senator Harkin. Thank you.
Senator Collins. I am now, before calling forth our next
panel of witnesses, going to turn to Senator Durbin to see if
he has any opening comments that he would like to make.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Madam Chair, thank you for having this
hearing, and I want to thank the witnesses. I am a cosponsor of
Senator Mikulski's bill, as well as Senator Harkin's, and
Senator Mikulski has agreed to cosponsor a piece of legislation
which I bring before us, as well.
This particular issue before this Committee has a rich
history. I did a little research and determined that when
Senator Ribicoff was Chairman of this Committee, from
Connecticut, and Senator Percy of Illinois was the ranking
minority, back in 1977 they conducted hearings on this question
about the adequacy of the Federal food safety inspection across
America.
It was curious, and I put the chart up there just for a
moment, the quote from the 1977 report of this Committee, and
it said: ``Divided responsibility for regulating food
production has resulted in a regulatory program which is often
duplicative, sometimes contradictory, undeniably costly, and
unduly complex. We believe the bifurcated food regulation
system should be unified in a single agency.''
I have introduced legislation to do that, and I hope that
we can in this Committee spearhead that legislation before
Congress. Twenty-one years on the same song. It is time for us
to basically move to action, and I commend you for your
leadership in doing that.
I hope that we can come up with a bipartisan response
quickly during the next session of Congress, that will not only
address the questions of funding and jurisdiction, but I think
the more central and unifying question about how to bring this
into one agency that avoids duplication, has standards that are
scientifically defensible, and basically can restore some
confidence.
The testimony of Senator Harkin about the Des Moines
Register poll I will bet would be reflected across this
country. People just believe food safety is a much bigger issue
than politicians do, and we have to be responsive. We should
be, not only because of our obligations under our oath of
office but also our obligations to our constituents.
We will now have, I am sure, an excellent panel here
representing several different agencies that are concerned
about this issue. I would hope that in the next year or two we
could call the same group together and perhaps have one witness
representing one agency with the responsibility for this--not
to take anybody's job away, but to bring them together in an
effort to make sure that this is more consistent.
Thank you for your leadership. You have really, I think,
served the country well in raising the profile of this issue.
Senator Collins. Thank you very much, Senator Durbin.
I am pleased to ask our next panel of witnesses to come
forward and remain standing so that I can swear you in. It
includes the officials from Federal agencies responsible for
regulating the safety of imported food, as well as the
representative of the National Academy of Sciences.
We are pleased today to have the Hon. Raymond Kelly, who is
the Commissioner of the U.S. Customs Service, the agency
responsible for regulating all commerce at our borders. Thomas
Billy, who is the Administrator of the Food Safety and
Inspection Service of the Department of Agriculture. That is
the agency responsible for regulating meat and poultry imports.
William Schultz, who is the Deputy Commissioner for Policy at
the Food and Drug Administration. As we know, the FDA is
responsible for the regulation of over 2.7 million food
shipments imported into the United States each year. And,
finally, to complete our panel we have Dr. Sanford Miller, who
is representing the National Academy of Sciences' Committee to
Ensure Safe Food. This panel recently sent to Congress an
excellent report analyzing various food safety proposals.
Pursuant to the Subcommittee's rules, all witnesses are
required to be sworn, so I would ask that you raise your right
hands.
Do you swear that the testimony you will give to the
Subcommittee will be the truth, the whole truth, and nothing
but the truth, so help you, God?
Mr. Kelly. I do.
Mr. Billy. I do.
Mr. Schultz. I do.
Dr. Miller. I do.
Senator Collins. Thank you. Since we are obviously running
very far behind schedule due to our late start today and the
intervening votes, I am going to ask you to adhere to the
request that you limit your written testimony--your oral
presentation--to 10 minutes each. We will include your entire
statement in the record. And the lights before you will give
you guidance on how much of your time is remaining.
We are going to start with Commissioner Kelly.
TESTIMONY OF HON. RAYMOND W. KELLY,\1\ COMMISSIONER, U.S.
CUSTOMS SERVICE, DEPARTMENT OF THE TREASURY
Mr. Kelly. Thank you, Madam Chairwoman, Members of the
Subcommittee. I am pleased to be here today to discuss Customs'
efforts to address the illegal importation of tainted food, and
I want to assure you that I and all of the employees of the
Customs Service share the level of concern raised by the
Subcommittee over the safety of food entering this country.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Kelly appears in the Appendix on
page 147.
---------------------------------------------------------------------------
Those involved in schemes to knowingly violate U.S. food
safety laws are driven by the same motives as those engaged in
narcotics smuggling: Greed. Just as we attack illegal drug
smuggling, the U.S. Customs Service will be vigilant in our
efforts to keep unsafe imported food products from showing up
in stores and restaurants throughout our Nation.
As you know, the U.S. Customs Service enforces more than
400 laws for 40 U.S. agencies, including the Food and Drug
Administration and the U.S. Department of Agriculture.
Approximately 25 percent of the enforcement work we conduct for
other agencies is for FDA. We are proud of the service we
provide because we know how important food safety is to the
American people.
This morning in my remarks, I will address the four
questions which the Subcommittee posed to me in your invitation
letter of August 20. Those questions are: What are the
deficiencies in the current food importing process? What
specific recommendations does the Customs Service have to
improve the safety of imported foods? What specific action is
the Customs Service taking in response to the April 1998 GAO
report on food safety? And what other changes should be
considered to improve the food import process?
In response to question 1, as you are aware, through
Operation Bad Apple, the Customs Service has identified a
number of areas in the food importing process that could be
better handled. These shortcoming can be broken down into three
subgroups: Cargo control, coordination issues, and sanctions or
penalties.
Cargo control deficiencies result in such scheme as banking
and container switching, and also include issues related to the
proper destruction of tainted food imports. Coordination
problems include the difficulty that Customs and the FDA have
had in sharing relevant information on suspect imports. With
regard to sanctions, the existing penalty structure may not be
strong enough to effectively deter noncompliant importers.
In response to question 2, there are a number of
recommendations Customs has been considering to improve the
safety of imported food. We believe it is necessary to
establish better control over the movement of suspect cargo
through the use of technology such as discrete transponders
attached to containers. We feel it is also necessary to improve
current methods of targeting violative importers through
expanded manipulation of existing data.
On the regulatory front, we would like to see the FDA's
Notice of Refusal also serve as Customs' Notice of Redelivery.
This would significantly cut down on the amount of time
necessary to process noncompliant importers. And, finally, we
think a national interagency team comprised of FDA
representatives and Customs trade compliance experts should be
established to coordinate our efforts on this front.
In response to question 3 regarding the GAO findings on
food safety, the Customs Service is taking action on those
recommendations which affect our responsibility. This includes
better coordination with FDA, better targeting and cargo
control, exploring the use of unique identifiers, destroying
and/or exporting tainted food, and more appropriate assessment
of sanctions against violators.
In regard to coordination with the FDA, we are
reprogramming our database to extract FDA-issued refusal
notices. This will allow us to have a clear list of FDA refusal
actions without relying on paper copies of such notices
transmitted in the mail. Again, we are seeking regulatory
authority to have the FDA Notice of Refusal serve as our
redelivery notice, which in so doing will automatically
obligate the Customs surety bond.
With respect to targeting and cargo control, Customs is
working with the FDA to target importers, high-risk producers,
and FDA violative shipments nationally. We will use an
automated information system to identify and subject these
shipments to additional examination. We are more effectively
coordinating our efforts at several ports and are experiencing
increased success at those ports where interagency teams have
been formed. We will look to expand this task force approach.
Although we want to better control food shipment, current
resource limitations prevent us from enforcing the laws in the
most effective way possible. The expanded use of bonded
warehouses and centralized examination stations has been
suggested. There are simply not enough examination stations at
this time, and those that exist are not equipped to provide the
needed storage.
As for bonded warehouses, Customs does not have the
authority to require their use. Even if we did, we do not have
the resources to supervise them properly. If we were to
implement these suggestions, Customs would be unable to assure
that switching of merchandise awaiting FDA examination would
not still occur. This also is complicated by the high cost of
building adequate facilities for these purposes at each port of
entry.
New technologies, such as the aforementioned transponders,
will help us track shipping containers from the place of
unlading to the examination station. In the coming months we
will test this technology at ports with high volumes of
suspected food shipments.
Now, when the FDA refuses a food shipment, we work with the
importer under the law to destroy or ensure exportation of that
shipment. Destruction of a shipment usually occurs at a
landfill or at an incineration plant. It can be difficult to
determine whether a shipment presented for destruction is the
actual refused entry.
Another challenge we face is that every port does not have
the resources to send an inspector to witness every
destruction. We estimate it would cost an additional $1.9
million annually to have inspectors witness the approximately
10,000 destructions that occur each year.
With regard to sanctions, we are seeking regulatory
authority in these cases to demand more than three times the
value of liquidated damages. We are also considering requiring
a separate bond for each shipment for repeat violators. Customs
is working with the FDA on more aggressive penalties where
importers fail to export or destroy FDA-refused products.
Furthermore, as we inquire into the activities of
importers, our investigative efforts often result in
indictments, arrests, convictions, and fines against those
making false statements, smuggling, or conspiring against the
United States. We intend to pursue our investigative activities
in this area and work closely with the Department of Justice to
ensure those involved in illegal activities are prosecuted to
the full extent of the law.
And, finally, in response to question 4, I will reiterate a
point I made earlier: Our role in the issue before the
Subcommittee today is not that of a lead agency, but rather as
an agency brought in to assist with the enforcement of policy
initiated by another agency. In this regard, I will defer to
the expertise of the FDA in determining other necessary changes
to improve the food import process.
In conclusion, I can assure the Subcommittee that the
safety of the Nation's food supply is important to the U.S.
Customs Service. We will continue to do everything we can, with
existing resources and in cooperation with the FDA, to keep
Americans safe from tainted and contaminated foods.
Madam Chairwoman, this completes my statement. Obviously I
am available to answer any questions. Thank you.
Senator Collins. Thank you, Mr. Kelly.
Mr. Billy, would you please proceed with your testimony?
TESTIMONY OF THOMAS J. BILLY,\1\ ADMINISTRATOR, FOOD SAFETY AND
INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE, ACCOMPANIED BY
MARK MINA, DEPUTY ADMINISTRATOR FOR FIELD OPERATIONS; AND
MARGARET GLAVIN, DEPUTY ADMINISTRATOR, OFFICE OF POLICY,
DEVELOPMENT AND EVALUATION
Mr. Billy. Madam Chair and Members of the Subcommittee, I
appreciate having the opportunity to appear before you today to
discuss the inspection system used by USDA's Food Safety and
Inspection Service for meat, poultry and egg products imported
into this country. Today I am accompanied by Dr. Mark Mina, the
Deputy Administrator for Field Operations, and Margaret Glavin,
the Deputy Administrator of the Office of Policy, Development
and Evaluation.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Billy appears in the Appendix on
page 154.
---------------------------------------------------------------------------
The FSIS inspection system ensures that all imported meat,
poultry and egg products meet U.S. food safety standards as
well as inspection and verification requirements. The Federal
Meat Inspection Act, Poultry Products Inspection Act, and the
Egg Products Inspection Act, give FSIS the authority and the
responsibility to inspect meat, poultry and egg products on a
continuous basis and set the food safety standards for these
products.
FSIS demands and certifies that imports are produced under
conditions that achieve the same level of protection as U.S.-
established standards for food safety. FSIS determines the
equivalence of foreign meat and poultry systems through on-site
reviews involving on-site visits to the foreign countries,
including randomly picking plants within those countries for
inspection, and document analysis of foreign countries' laws,
regulations and other pertinent information.
The amount of meat, poultry and egg products imported into
the United States is very small compared to U.S.-produced
products. Imported meat accounts for only about 7 percent of
the domestic consumption, imported poultry totals less than 1
percent, and imported egg products also totals less than 1
percent, and these numbers have been relatively static over the
last 10 years.
Not one pound of these imported products is permitted entry
into the United States unless it has undergone inspection in a
system certified by FSIS as equivalent to the FSIS inspection
system. Only 37 countries have been certified as meeting our
standards.
Meat and poultry products consumed in the United States but
originating abroad are the most heavily inspected food products
in the world. As I noted, imported meat and poultry are
required to be inspected under a foreign inspection system that
FSIS has determined to be equivalent to our own system. Then,
upon arrival at the U.S. port of entry, all meat and poultry
shipments undergo reinspection by FSIS. Almost all imported
products, about 85 percent in total, then proceeds to a
federally inspected meat or poultry plant for further
processing under the supervision of FSIS inspectors.
The dramatic changes being instituted in our domestic meat
and poultry inspection program directly impact foreign
countries desiring to export products to the United States. In
1996, we published the pathogen reduction Hazard Analysis and
Critical Control Points, or HACCP, systems' final rule.
HACCP systems are geared towards preventing problems before
they occur rather than detecting problems after they occur. All
of the requirements in the rule, including the microbiological
testing, must be implemented by foreign inspection systems
desiring to establish eligibility or to maintain their
eligibility to export to the United States.
In closing, I would like to say that we at FSIS are
continually striving to improve our inspection system, with a
goal of minimizing the incidence of foodborne illness from the
consumption of meat, poultry and egg products, whether those
products are produced in the United States or a foreign
country. Thank you for the opportunity to discuss our import
inspection system, and I look forward to any questions you
have. Thank you.
Senator Collins. Thank you, Mr. Billy.
Mr. Schultz, would you please proceed?
TESTIMONY OF WILLIAM B. SCHULTZ,\1\ DEPUTY COMMISSIONER FOR
POLICY, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES, ACCOMPANIED BY JOSEPH LEVITT, DIRECTOR, CENTER
FOR FOOD AND APPLIED NUTRITION; AND GARY DYKSTRA, DEPUTY
ASSOCIATE ADMINISTRATOR, OFFICE OF REGULATORY AFFAIRS
Mr. Schultz. Thank you, Madam Chairman. With me today are
Joseph Levitt, who is the Director of our Food Center, and Gary
Dykstra, who is the Deputy Associate Administrator for
Regulatory Affairs, which is the division of the agency that
oversees the field operations, including import inspections.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Schultz appears in the Appendix
on page 159.
---------------------------------------------------------------------------
We appreciate the opportunity to testify, and I would like
to compliment the Subcommittee on these hearings, which
obviously address a very important topic, namely the adequacy
of the Federal programs to assure the safety of imported food.
These hearings have identified a number of serious problems.
The witnesses have offered a number of very constructive
suggestions.
We are not here to say that we know all the answers, but we
certainly recognize that there is tremendous room for
improvement in the FDA's food import program, and what I would
like to do is start the discussion by talking for a few minutes
about some of the trends and factors that have brought us to
where we are today.
The first one is the dramatic growth of imports in recent
years, and as you can see from the chart, in the mid-1980's
there were about 1,000 what we call line items of food offered
for import in the United States--not 1,000 but just under 1
million line items offered. If we jump to 1998, it is over 3
million. And what that means is, today a significant amount of
the food that we eat in this country is imported. That includes
over 50 percent of seafood that is consumed, 38 percent of
fresh fruit, and about 12 percent of fresh vegetables.
Second, the imported food that we are seeing is much more
complex than it used to be. In the past, many imports were raw
materials, bulk products, products that were brought into the
United States and then used in processing food, so the food was
both inspected at the border but then often it could be
inspected domestically when the FDA inspectors went into
processed food facilities. Today what we are seeing is fresh
produce, fresh seafood, and thus it is all the more important
that we get it right before the food comes into this country.
Making the problem even more difficult is, as has been
mentioned in testimony, what we call emerging pathogens. We are
seeing, both domestically but also in imports, kinds of
bacteria that we just didn't see only a few years ago. They are
often hard to detect, and they are often more virulent than
what we have seen in the past.
And then finally is the issue of resources, which simply
are not sufficient to do the job. So the bottom line is that
while food imports have increased by more than 300 percent in
recent years, the FDA's resources devoted to this program have
not only failed to keep up, they have been declining slightly.
That is the bad news. Now I would like to give you the good
news. The good news is that food safety today is front and
center at FDA. In recent years our agency has had what I think
are some great successes. We have fixed the drug lag. We have
greatly improved medical device review times. And then just
recently we have put a tremendous and, I think, very successful
effort into implementing the FDA Modernization Act, which this
Congress passed just a year ago.
But during those years food safety has been, frankly, on
the back burner. That is no longer true. For the last 2 years
food safety, which includes of course the safety of imported
food, has been a priority.
Part of the answer, we think, is new resources, but that is
not the whole answer. Instead, there is also tremendous room
for improvement in our existing program, and in this regard the
General Accounting Office report that you commissioned makes a
number of very important suggestions. And those suggestions
range from how FDA sets its priorities to authorities that are
needed, including for example one simple authority, which would
be the ability for FDA to require that goods that are refused
import be marked so that they can't be reimported from another
port.
But in addition to the resources and improving the existing
program, we believe that a whole new approach is needed to this
problem, and that we can no longer simply rely on inspections
at the border. Instead, we must find a way to prevent food from
being contaminated before it is brought to our border. We must
find a way, in other words, to go the source of the potential
contamination.
And thus it is our view that the import program of the
future will look very different from the import program that
you are examining today. While we will continue to rely to some
extent on dockside inspection, we know that even with a vast
increase of resources, those kinds of inspections won't be
adequate.
And therefore, any new resources that FDA gets, a
considerable amount of them would be devoted to working with
foreign governments in improving their regulatory systems, and
to basically going abroad, looking at the farms, looking at how
the food is produced, and strengthening those systems. The goal
of this would be that any food imported into this country be
produced in a country that has a regulatory system that is as
good as the one in the United States.
As part of this program, we believe that FDA needs the
ability to refuse imports from a country that doesn't have an
adequate food safety regulatory system of its own. Implementing
this kind of program will take time, but we believe that for
the future it is essential in order to assure the safety of
imported food.
In conclusion, Madam Chairman and Senator Durbin, I would
like to say we appreciate the support of the Members of this
Subcommittee in voting to increase our food safety budget when
the appropriations bill was amended on the Senate floor last
July, and in the coming months we look forward to working with
you on substantive legislation and on other measures that we
can take to improve this program.
We would, of course, be happy to answer any questions.
Senator Collins. Thank you very much, Mr. Schultz.
Dr. Miller, we look forward to your testimony.
TESTIMONY OF SANFORD A. MILLER,\1\ MEMBER, COMMITTEE TO ENSURE
SAFE FOOD FROM PRODUCTION TO CONSUMPTION, NATIONAL ACADEMY OF
SCIENCES
Dr. Miller. Thank you, Madam Chair. I am Dr. Sanford
Miller. I am Dean of the Graduate School for Biomedical
Sciences at the University of Texas Health Science Center in
San Antonio, and I served as a member of the Committee to
Ensure Safe Food From Production to Consumption of the National
Academy of Sciences. It is in that context that I join with you
today.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Miller appears in the Appendix on
page 180.
---------------------------------------------------------------------------
I am pleased to have this opportunity today to comment on
this issue of food safety, so vital to the public health. The
study that I will address today was requested by Congress. In
order to provide a context for the issues related to imported
foods contained in our report, I would like to first address
the questions you asked related to the recommendations included
in the report, and then follow by addressing the findings of
the committee related to imported foods in response to the
other two questions that were posed by the Subcommittee.
The first question was, What recommendations were offered
by the committee to establish an effective food safety system?
The report, ``Ensuring Safe Food From Production to
Consumption,'' came to three primary conclusions, and from
them, several recommendations.
The first conclusion was, ``An effective and efficient food
safety system must be based in science.'' The second conclusion
which follows from that was, ``To achieve a food safety system
based on science, current statutes governing food safety
regulation and management must be revised.''
This second conclusion resulted in two recommendations:
First, that Congress should change Federal statutes so that
inspection, enforcement and research efforts can be based on
scientifically supportable assessments of risks to public
health. Some of the science-based changes in Federal statute
proposed by the committee were elimination of the current
continuous inspection system for meat and poultry and
replacement with a science-based approach which is capable of
detecting hazards of concern. Second, mandating a single set of
science-based inspection regulations for all foods; there are
common factors for all foods. And, third, requiring that all
imported foods come only from countries with food safety
standards deemed equivalent to U.S. standards.
Second, the second conclusion, that Congress and the
administration should require development of a comprehensive
national food safety plan. Funds appropriated for food safety
programs, including research and education programs, should be
allocated in accordance with science-based assessments of risks
and possible benefits to the public.
A well-developed national food safety plan formulated by
Federal food safety agencies, and with representation from the
many stakeholders involved in ensuring safe food, is vitally
needed. It should include consideration of the distinctive
efforts required to ensure the safety of imported foods, and a
plan to address consumers' behaviors related to safe food
handling processes, since that is the final line of defense.
The third conclusion was related to the need for
reorganization of food safety efforts in the United States:
``To implement a science-based system, reorganization of
Federal food safety efforts is required.''
This resulted in two recommendations: First, to implement
the science-based system, Congress should establish by statute
a unified and central framework for managing Federal food
safety programs, one that is headed by a single official, and
which has the responsibility and control of resources for all
Federal food safety activities, including outbreak management,
standard-setting, inspection, monitoring, surveillance, risk
assessment, enforcement, research, and education.
The current fragmented regulatory structure is not well-
equipped to meet current challenges. In order for the
organizational structure not to be a barrier to food safety,
one official should be responsible for Federal efforts in food
safety and have control of all resources allocated to food
safety. An identifiable, high-ranking, presidentially appointed
head whose appointment is based in statute, and thus is not
temporary or easily changed by political agendas or executive
directive, is required to direct and coordinate Federal
activities and speak to the Nation, giving Federal food safety
efforts a single voice.
Since the Food Safety Council recently established by the
President's executive order was announced following release of
the committee's report, our report does not identify or
evaluate that organizational structure.
The second recommendation regarding organization structure
is as follows: Congress should provide the agency responsible
for food safety at the Federal level with the tools necessary
to integrate and unify the efforts of authorities at the State
and local levels to enhance food safety. This would include
statutory measures and funding necessary for the Federal
Government to be able to ensure nationwide adherence to minimal
standards when it is deemed appropriate.
Now, if I may, I would like to address the questions of
imports and risk assessment. With regard to how scientifically
supportable assessments of risk to public health can be used to
create more effective safeguards to protect the public, and the
extent to which resources can be better allocated if regulatory
decisions are based on scientifically developed data, the
report does point out that decisions need to be based on
assessments of risk to public health, and that resources should
be allocated towards those that indicate the greatest risk to
health.
However, the report also recognizes that great gaps exist
in the information needed to develop some of these assessments,
in which case judgments need to be based on whatever scientific
data happens to be available. Therefore, significant research
is required to fill these gaps. Some hazards may need to be
provided resources even though there may be other areas that
pose greater risk to public health, but for which additional
resource allocation would have little likelihood of more
effectively protecting the public health at this time.
With regard to the current import process and possible
deficiencies, if any, identified by the NAS report, the
committee recognized that the globalization of the U.S. food
systems brings foods from all parts of the world into the U.S.
marketplace, and with it the potential for foodborne infections
or other hazards not normally found in the United States. In
the United States, the production, processing and shipment of
food can, in theory, be subject to government monitoring from
harvest to consumer purchase, but imported food is not subject
to similar oversight.
It is by no means clear that imported food as a class poses
greater risks than does domestically produced food. What is
clear is that Federal officials cannot use the same methods to
regulate imported food that they use, or that would make sense,
in regulating domestically produced food. Uniform or harmonized
food safety standards and practices should be established, and
officials allowed to undertake research, monitoring,
surveillance and inspection activities within other countries
in accordance with science-based assessments of risk and
benefit.
The laws that FSIS and FDA administer require that imported
food meet the same standards as domestic food, but, as the
Subcommittee is well aware, the enforcement approaches of these
two agencies to meet this common requirement are quite
different. The different systems of scrutiny of imports used by
FDA and USDA largely mirror their different approaches to
domestically-produced food, as is required, since they must
document domestic equivalence.
USDA statutory authority requires meat and poultry food
safety systems of exporting countries to be equivalent to the
U.S. system. However, FDA lacks the authority to require that
imported foods be produced under a system equivalent to the one
that it administers domestically. Instead, FDA, as you know,
relies primarily on sampling at ports of entry to determine
whether food imports meet domestic requirements.
Even if FDA's criteria for sampling and testing were
systematically risk-based and its resources were adequate to
keep up with an increasing volume due to increased demand,
sample analysis alone is not capable of detecting many of the
most serious risks to consumer health. There is currently no
way to determine whether the agencies are focusing their
attention on the most important health risks.
In an effort to address the challenges of ensuring the
safety of imported foods, the President has proposed a variety
of measures, including hiring additional FDA inspectors to
examine the safety of fruit and vegetables in the marketplace,
both domestic and imported. Recognizing that sample analysis
alone does not provide a means for detecting many of the most
serious risks to consumers' health, and without firm knowledge
of the most significant risks, it is simply impossible to know
whether these proposed actions will adequately address imported
food hazards.
On behalf of the National Academy of Sciences' Committee to
Ensure Safe Food From Production to Consumption, I thank you,
Madam Chairman and Senator Durbin, for this opportunity to
present our testimony at this hearing, and of course we will be
happy to respond to any questions.
Senator Collins. Thank you very much, Dr. Miller.
We will now have a 10-minute round of questions per
Senator, and I would like to start with you, Mr. Schultz, to
talk about the issue of equivalency authority. You and I have
talked privately, and as well as in your testimony this
morning, you have made the point that with the huge volume of
shipments that the FDA has to deal with, which your chart well
illustrates, when you're dealing with 2.7 million shipments per
year, that even if we quadrupled the number of inspections,
that you can never catch up. Is that fair? And given the fact
that many emerging pathogens are so difficult to detect from a
visual inspection or even sampling, that we are still not
getting at the root of the problem?
Mr. Schultz. That is right. Today we only look at 1.7
percent of imports, so quadrupling it we think still would not
be the answer.
Senator Collins. And that is the appeal of having some sort
of equivalency standard; of saying that unless other countries
meet American standards, we are not going to import fruit and
vegetables from them, similar to what FSIS does, but there are
some important differences.
And that approach has a great deal of appeal to me because
it does go to the root cause, but I am concerned about how
practical it is. And I think there are a lot of issues that we
need to work through before going that route, even if that is
the ultimate answer.
In 1994, GAO, which has been advocating equivalency for
some time, issued a report calling for equivalency, and FDA
said then that it would ``be virtually impossible to impose
U.S.-equivalent regulations on other nations,'' and FDA drew
the contrast that fruit and vegetables are produced in
decentralized locations, as opposed to FSIS is mainly dealing
with centralized processing plants or slaughterhouses when it
comes to meat and poultry.
Given those differences, how would you go about
implementing equivalency? How practical is it?
Mr. Schultz. It is a very important point, Senator Collins.
As I understand it, equivalency has special meaning in the
international trade jargon. It involves what is a certification
of the other country's system, and it often involves an
agreement that takes a lot of resources and a long time to
negotiate. We don't know that full equivalency, mandatory
equivalency, is necessarily the best approach.
What we do think we need, though, is both the resources to
go and work with other countries to strengthen their systems,
and the authority to be able to say to those countries, ``If
your system isn't adequate, if it's not as strong as ours, then
we have the ability to refuse to import your product.
We want to put the responsibility back on you, not that you
have to do it exactly the same way the United States does, but
that basic sanitation measures and so on must be taken.''
And we need a way not just to work with them but to make
them listen to us when we tell them: ``You need to strengthen
your system. Otherwise, we may choose not to import your
food.''
Senator Collins. Some domestic fruit and vegetable
producers have raised concern to me that if we move to an
equivalency system, that it will mean that FDA or the
Department of Agriculture has to impose a whole new set of
burdensome regulations for our domestic industry, when there
isn't necessarily a problem, in order to show equivalency or
equivalent standards. Could you comment on that issue? Is that
fear justified?
Mr. Schultz. I think it is an understandable concern but I
think it is a misunderstanding of the approach that we are
advocating. It is true that in order to tell another country or
talk to another country about what its standards ought to be,
you have to know what your own standards are. But those
standards are found in our laws, in our regulations, and we are
also issuing guidances to our own industry about what the
standards are.
Here we are talking mostly about basic sanitation
standards. We are talking about standards that already exist in
this country, and what we need to do is describe them so that
other countries know what we are expecting of them.
Senator Collins. So if we move to that system, you would
not see it as imposing a host of new regulations on domestic
producers, because we are in essence talking about basic
sanitation standards which they already meet. Is that accurate?
Mr. Schultz. We think that is accurate. We think we have a
very important education role to play, and we have started on
that. We believe we are having success in talking to our own
agricultural industry and in explaining what we have in mind.
There are, of course, variations in this country, and I
don't want to sit here and say that every facility in this
country is going to meet those basic standards, but we are
talking about basic standards that we believe most of the
facilities do already meet.
Senator Collins. Could you explain to the Subcommittee what
authority the FDA currently has to ban a product that is
suspected of containing pathogens? In the case of the
Guatemalan raspberries, which this Subcommittee explored in
depth, the FDA did take action to ban the importation during
the spring months when the problem with Cyclospora
contamination was greatest, so you obviously have some existing
authority to protect the public health.
Mr. Schultz. Right.
Senator Collins. What is that authority? Do you need new
authority that goes beyond that?
Mr. Schultz. We are now looking at this, too, I must say,
and there are debates about it. But the basic approach we have
taken up to now is reactive. In other words, we identify a
problem such as Guatemalan raspberries, we look at the product
and we know there is a problem with the product, and then we
have the authority to take action which can go as far as
banning the product, but it is where we know there is a
problem.
What we are looking for, toward, in the future is a
preventative approach where we can say we might not know about
this particular product, but we can see from the way products
are handled in your country, from the lack of regulation, that
there is a potential for a problem, and we basically want to
work with you to improve the system in your own country. But
you need to know that if you don't do that, we have the ability
to prevent the import, not because we are looking at the
product but because we can see the potential for a Guatemalan
raspberry type of situation in the future.
Senator Collins. Mr. Billy, I want to explore with you how
the equivalency process works for FSIS. Now, in your case it is
my understanding that you have equivalency agreements or
certifications with 37 nations. Is that correct?
Mr. Billy. Yes.
Senator Collins. We know that our Nation is importing fruit
and vegetables from considerably more countries, some 90
nations. Have you turned down specific countries, or are you
still going through the process of certifying their standards?
Give us some idea of how the 37 countries compares with the 90
countries that are now exporting fruit and vegetables to us.
Mr. Billy. We currently have 20 countries in the queue,
lined up to demonstrate that they have equivalent inspection
systems, standards, laws, regulations, to qualify for exporting
meat and poultry products to the United States. And we are very
actively involved in reviewing first the paperwork and the
actual systems in place, and if we ultimately conclude that
they are equivalent, then we will certify them and permit the
shipment of products to the United States.
We have in the past declined to approve countries. We have
also delisted countries when we found that their systems
changed and became unacceptable in terms of--or not qualifying
in terms of equivalency.
I think this idea of equivalency is at the heart of the
success that we have in terms of dealing with imported meat and
poultry products. As I assume you are aware, I worked for the
Food and Drug Administration, and I was frustrated by the
limitations that they had in terms of their authorities, and I
think this is a very important area that this Subcommittee
needs to look at and judge.
Finally, we just recently put in place our new HACCP
regulations, and we are now in the process of going back
through all of the 37 countries to verify that in fact the new
regulatory requirements have been addressed by these 37
countries, and ensuring that they have in place HACCP-type
regulations that have been implemented, that the slaughter
plants are testing their processes for E. coli, and that they
are going to meet the salmonella performance standards that
were established. So this is not a one-time effort. In other
words, it is an ongoing effort, and you need the resources, the
capacity to deal with it on an continuing basis.
Senator Collins. Have the international trade agreements
posed any difficulties for you in negotiating or certifying the
equivalency standards in other countries?
Mr. Billy. I can say this, that at this time we haven't
been challenged in terms of our approach to determining the
equivalency of the foreign systems. That concept in the new
requirements in the trade agreements is relatively new, and we
are working hard to ensure that the approach we take will work
not only effectively for us in terms of imports, but also with
regard to what we would expect when we export food products. We
are one of the largest exporters of food worldwide, and this
same concept I believe will work well for us in terms of
sustaining and hopefully increasing our exports worldwide.
Senator Collins. Thank you. My time has expired.
Senator Durbin.
Senator Durbin. Thanks, Madam Chair.
Let me ask just one threshold question which I think I know
the answer to, and that goes back to this finding not only by
the National Academy of Sciences but the General Accounting
Office on 12 different occasions over the last 6 years calling
for one single Federal food safety and inspection agency with
coordinated jurisdiction, scientifically-based.
Is there any member of the panel, particularly Mr. Schultz
or Mr. Billy, who disagrees with that? Do you think that that
standard will not result in a safer food supply, saving
taxpayers some money, and at least making the bureaucracy more
comprehensible to those who are affected by it?
Mr. Schultz. Senator Durbin, as you may know, after the NAS
issued its report, the President established a council, and one
of its charges was in 180 days to look at this very issue and
make a recommendation. So the report is being studied.
The administration did 2 years ago issue a report, and I
would like to submit it for the record.\1\ It is called ``Food
Safety From Farm to Table,'' but it is a comprehensive approach
to food safety that includes risk assessment, research, and
inspection. Coordination is a big piece of it, and surveillance
by the CDC. And I would like to submit it and ask anybody who
is interested to look at it. This here to date has been our
approach to the issue.
---------------------------------------------------------------------------
\1\ The report appears as Exhibit No. 5 in the Appendix on page
386.
---------------------------------------------------------------------------
Senator Durbin. Mr. Billy.
Mr. Billy. I agree that I think it is important for the new
Food Safety Council established by the President to do a
comprehensive review of all of the recommendations made by the
National Academy. I also would point out that the new council
plans to establish a National Strategic Plan for Food Safety,
and that is one of the key recommendations made by the Academy.
The new council plans to develop a unified food safety budget
and submit that annually to the Congress. That is another
recommendation of the National Academy.
And, as Mr. Schultz has indicated, we plan to do an in-
depth review of the Academy report, so I think we ought to
provide an opportunity for that to occur and then see the
specific conclusions and reaction of the administration to that
Academy study.
Senator Durbin. This is a serious issue. We should take it
seriously. We should make certain that the procedure that we
follow is one that is in the best interests of food safety,
among our major obligations to people in this country.
Having said that, 21 years ago this Subcommittee accepted
the premise that we have too many Federal agencies that have
responsibility in this area. Twenty-one years ago they started
calling for us to consolidate this, maybe even before, but at
least 21 years ago, into one agency.
I have introduced legislation with Congressman Fazio and
Senator Torricelli in an effort to do that. Why don't we just
accept the premise that we should have one agency,
scientifically based--and then talk about how we reach that
goal? I hope--I don't want to sound frustrated, but I am--that
we can at least agree on that.
Dr. Miller, I see you shaking your head. I think after your
study you understand that.
I want to ask some questions of Mr. Kelly, and I thank you
for being here today. Senator Collins, when she called the last
hearing, brought before us testimony from people who are
involved in this business of food importing and how they
defraud our process and our government, and you have done some
good work with the Customs Service. Let me talk about two
specific areas and ask you what you would do about them, and
you mentioned them in your testimony.
You testified that ``banking and switching'' by importers
poses a continuing challenge. Are there specific solutions for
tagging food in some way that will help prevent or eliminate
this problem?
Mr. Kelly. We are looking at a variety of things, Senator.
We think technology in this area can certainly be helpful. We
are looking at ways to perhaps use identifiers that only come
out under black light, putting markers on containers. We are
exploring a whole array of areas, but right now, it is
unrealistic to think that we have the resources to adequately
trace a load of suspected food from where it is stored to,
let's say, an incineration plan. I believe technology is the
answer in this area, and our people are looking at a variety of
things. I think we will come up with something in the near
term.
Senator Durbin. Do you have the resources to do this? I
mean, is it within the Customs Service resources, budget, and
ability to try to find this new technology?
Mr. Kelly. Yes. I think we can find the technology. The
money to purchase the technology might be another issue.
Senator Durbin. Another story, but once we come to that
conclusion, do you feel you can reach some sort of a finding
that will lead us to that?
Mr. Kelly. Yes, sir. Now, we have a lot of talented people
in the technology area that have some pretty innovative ideas.
I believe the agency can come up with the solution. Finding the
resources, of course, is always a challenge.
Senator Durbin. Let me ask you another question: Do you
think that the current policy of giving importers the option of
destroying the rejected shipment or reexporting the product
back to its origin or elsewhere is a problem?
If you had been here at the previous hearing and heard the
testimony--this will put you off your feed for a few minutes--
of a shipment of fish, if I remember correctly, rejected, then
returning to the United States several years later as frozen
fish, here it comes again. Why shouldn't destruction be the
only recourse, given some of the reported incidents such as
this that find these rejected, unsafe, adulterated products
finding their way back to the United States even years later?
Mr. Kelly. Senator, it makes sense to me to have
destruction be the only alternative. However, I am pretty new
at my job, about a month and a half, and I think we have to
think out all of the consequences, or at least I have to have
them explained to me. But certainly my initial reaction is, why
reexport?
Senator Durbin. Does Customs have the authority to bar
violators, such as the top ten identified in Operation Bad
Apple, from importing or doing business?
Mr. Kelly. No, sir, we do not have that authority.
Senator Durbin. What factors do you take into consideration
in determining fines and penalties?
Mr. Kelly. The record of the importer obviously is a
significant consideration. If in fact one is a repeat violator,
then the fines themselves would naturally be increased.
Now, we are limited as far as imposing fines, moving
against the bond, to three times the entry value. So even if we
find an egregious violator and we are moving in that area, we
are limited to three times the entry value. We are examining
the possibility of expanding that to a level of the domestic
value, in other words the market value of what the commodities
would bring.
There is a whole series of areas that we look at,
particularly the record of the individual, the size of the
shipment, those sorts of considerations, in determining a
penalty.
Senator Durbin. And do I understand that you are
considering raising the bond requirements for repeat offenders?
Mr. Kelly. We are considering raising the bond requirement,
yes, sir.
Senator Durbin. Well, let me say that the testimony we had
from a previous hearing suggested that some of these folks
consider this the cost of doing business. They will just
violate the law and hope they don't get caught, and assume that
when they do, it is just another cost. It really doesn't slow
them down or stop them.
When I hear that you don't have the authority to literally
ban them from future importation in the United States, and that
you are really limited in the fines you can charge, I am glad
to hear that you are taking another look at it. I think that is
critically important.
Mr. Schultz, let me ask you the same question about
reexport or destruction. I think that is something that the FDA
should be thinking about, as well.
Mr. Schultz. I agree that it is something we should look at
carefully. I am reluctant to give you a categorical answer
because I can imagine a situation where the violation is pretty
trivial, not necessarily going to the safety of the food. It
could go to the labeling or something, where the food could be
rehabilitated, and you are obviously talking about very large
amounts of money on occasion. So I am a little reluctant to
give you a categorical answer, but I think I agree with your
sentiment.
Senator Durbin. People make mistakes, but the testimony
before this Subcommittee--was it rice sticks that we were
dealing with here? We had a company that clearly was a bad
actor, and decided to mislabel their product in order to escape
inspection and scrutiny. And so I think we ought to have some
sort of a fair judgment standard here, that if it is an
innocent mistake, it is one thing, but mislabeling in and of
itself can be reasons for us to come down hard on these people.
I see my time is about to expire, Madam Chair. I see
Senator Levin is here, but I will try to stay for another round
of questions. Thank you.
Senator Collins. Senator Levin.
OPENING STATEMENT OF SENATOR LEVIN
Senator Levin. Thank you, Madam Chairman, and thank you
again for your leadership in this area. It is critically
important, and it has been very, very strong, and we are all in
your debt and the Nation is in your debt for doing what you are
doing here.
I am interested in the weak fines to start with. We have
got maximum fines, as I understand it, FDA, for the
misdemeanor, of $1,000 or a year in prison. I doubt very much
that the prison sentence is used very often, although I could
ask you about that, but a $1,000 fine, it seems to me, for
introducing bad food into this system of ours, is just nothing.
It is hollow. There is no threat there; there is no deterrent.
I am wondering if you would comment on this, Mr. Schultz,
because I am very much interested in introducing a bill, and I
will be, that would significantly up the fines for violations
of our laws, both misdemeanor and felonies, both for FDA and
for the Department of Agriculture. But first, your comment on
the current system. Is it as weak as it seems to me in terms of
penalties and fines for violations?
Mr. Schultz. We agree that there are serious inadequacies,
and we would be happy to work with you on legislation. While
the criminal sanctions are important, I think it has been
pointed out they often don't work. They can be too harsh. They
require the Justice Department agreeing to bring a prosecution,
and the Justice Department has to weigh this against everything
else it is doing. And we do have to find a way so that
importers don't regard the fines or the forfeiting of bond as
simply the cost of doing business.
Senator Levin. Well, there is a number of ways in which we
can deter. And we have talked about equivalency is one way of
doing this, as well, and I want to get to that, as others
already have, in a moment.
But if people face significant penalties for violation, at
least it is something of a deterrent. If they face a $1,000
fine, or if they just simply lose their bond and their bond is
three times declared value, and declared value is much less
than what the value is on the domestic market, it becomes a
hollow threat. And so these penalties do provide some
deterrent, and that is why I want to focus on this.
One additional way to apply a penalty is a civil penalty,
so that you don't rely so heavily on the Justice Department.
And, again, I am going to be addressing this in legislation.
Have you looked at that possibility, at other agencies', indeed
your own agency's use of civil penalties? Why should we not
here provide for the possibility of a civil or an
administratively laid penalty, as well as the possibility of a
criminal penalty?
Mr. Schultz. And GAO recommended this, and we think it is a
very constructive recommendation. We would be happy to work
with you.
Senator Levin. And, Mr. Billy, let me ask you the same
question for the Department of Agriculture. Your penalties are
about the same, $1,000 for a misdemeanor. I believe you have a
slightly larger one for a felony, but--and the jail term, it
seems to me, is not a realistic, likely outcome as a practical
matter in the world in which we are in, in terms of all the
priorities we have. It just isn't likely to happen. Whether it
should or not is a different issue. But we have to hit folks in
their pocketbook, and it seems to me we are not doing that in
many ways. So, Mr. Billy, would you comment on the fine formula
that you folks use at Agriculture?
Mr. Billy. We have an inadequate inability to assess civil
fines to enforce our regulations. We sent forward legislation
which was introduced by Senator Harkin. It is called the Food
Safety Enforcement Enhancement Act. It was introduced last
year, and it lays out specifically the kind of civil penalty
authority we would like to have, and we think this is a
critically important tool we need as we move forward in terms
of improving food safety.
Senator Levin. And in addition to civil penalties, your
penalty for--your criminal penalty is $1,000, is that not
correct, or a year in jail, for a misdemeanor?
Mr. Billy. Yes, but we do in fact use the criminal
penalties provisions, and there are several people currently in
prison that are there because of serious violations of our
regulations.
Senator Levin. Is that for a misdemeanor violation or a
felony?
Mr. Billy. Felony violations.
Senator Levin. On the misdemeanor side, do you have any
folks that have been given a year?
Mr. Billy. No. We need additional authority there to deal
with that area, as well.
Senator Levin. All right. And is it not correct that your
fine on the misdemeanor side is $1,000?
Mr. Billy. I believe that is correct, but I would like to
check that.
Senator Levin. All right, and you could use some additional
strength there?
Mr. Billy. We could definitely use some additional strength
there.
Senator Levin. All right. The bonding issue which Customs
has talked about, I think has already been addressed in Senator
Durbin's questions. Perhaps other Senators have also asked
questions about it, so I will not ask about that, but I think
that is also a very helpful direction.
On the equivalency issue, one of the arguments which the
Chairman said has been raised against equivalency is the issue
of whether or not that would then lead to greater domestic
regulation, and your answer I believe was that in your judgment
it would not.
Is there any reason why a bill that would be granting FDA
equivalency authority should not contain a provision which says
``nothing in this bill is intended to require the FDA to do any
regulation that it otherwise would not be doing anyway''? That
is not a very artful or legal way to phrase it but I think you
get the drift----
Mr. Schultz. Right.
Senator Levin [continuing]. That the bill isn't intended to
force you to do regulating you wouldn't otherwise do, just to
say in the area where you have regulated and you have
standards, that we simply want other countries to have
equivalent standards if they are going to import foods into the
United States.
Is there any reason that you can see why such a bill could
not contain that kind of language?
Mr. Schultz. No. Obviously we want to look at the language.
I would want to consult with the lawyers and others at FDA. But
sitting here, I don't see a reason why that would be a problem.
Senator Levin. Well, it is something perhaps that could be
considered as a way of addressing the issue which has been
raised, which the Chairman has already referred to.
Just one other question that I have, and that relates to
the equivalency as well, and that is another question which the
Chairman has raised. She said that one of the questions is
whether or not we would have the resources to go into other
countries and inspect, and because it is so decentralized in
other countries compared to slaughterhouses, that it would be a
much more difficult inspection system.
But even if there were very modest inspection in other
countries, isn't equivalency at its heart a determination by
the agencies that the other countries have a system which will
give us the same level of protection? And even though our
inspection to assure that that is true may be less than
desirable, nonetheless, it doesn't take a whole lot of
inspection to see whether there is a system in place. Now,
whether it stays in place and is applied to every decentralized
field or producing facility is a different issue. But isn't the
heart of equivalency that determination as to whether a system
is in place, and that indeed does not require a huge amount of
inspections or resources?
Maybe Mr. Billy first, because I think they have got a
system.
Mr. Billy. I think you have put your finger on something
important here, and it does take some resources, and I will use
an example, but I think your point is well taken. It is the
system that you are looking at and evaluating, and a lot of
that can be done through the exchange of material, periodic
visits by inspection personnel and others that validate or
verify that the system will be reliable.
But I also want to point out that, as I mentioned earlier,
we now are verifying that the 37 countries are complying with
our new regulatory requirements or HACCP, and it is no small
task. We have received volumes of paperwork from these
countries in their home language, which we have translated to
provide the basis for us to make these evaluations. So there is
an infrastructure that is needed with the capacity to deal with
even this kind of systems evaluation. But I think your point is
well taken in terms of the system being the point of emphasis.
Senator Levin. Thank you. Thank all of the witnesses, and
Dr. Miller particularly, thanks to the Academy for the
important work you have done in this area.
Dr. Miller. Thank you.
Senator Collins. Thank you, Senator Levin.
Our witnesses may feel that they have caught a break. We
have another vote that has just begun. We have time for one
more round of 5 minutes each per Senator, and then I am going
to ask that we submit the rest of our questions for the record,
and I will adjourn the hearing when we go to vote. We look
forward, however, to continuing our dialogue with all of the
witnesses.
Commissioner Kelly, I want to ask you a little bit more
about the idea of using a bonded warehouse for some shipments
to be held if they are suspected of contamination. Some of the
weaknesses that we have uncovered in the process is that FDA,
unlike FSIS, allows the importer to keep control for up to 90
days of the suspect shipment, and also allows the importer to
select his or her own laboratory to perform the tests. There is
lots of opportunity for deception and fraud in the process.
You mentioned, and I think it is a very valid point, that
given the huge number of shipments we are talking about with
the FDA, that requiring the use of bonded warehouses is
probably not practical. It would be too costly. However, isn't
there another approach?
I know we talked at the last hearing that Customs had a top
10 list of violators of our import laws. I personally think
anyone who makes the top 10 list should probably be banned from
the industry forever. But couldn't we have a middle ground
where problem importers who violate health and safety laws are
required to have their goods controlled at a bonded warehouse?
Do you think that would be an appropriate approach?
Mr. Kelly. It might very well be, Madam Chairwoman.
However, I am told that we don't have the authority to do that
now, and then there is an issue of supervision. Once you put
something in a bonded warehouse, Customs or some entity has to
supervise it. We have problems with other bonded shipments now.
I mean, I think the whole area has to be looked at in depth.
That is something we intend to do in the Customs Service.
But it is complex, and we just--again, it is an issue of
space. If we could identify the top 10 violators, then it may
in fact have some viability and be something we should look at.
But, again, we are all under resource constraints, and when you
talk about supervising even the top 10 violators, you know, it
is a drain. But it is something I would be glad to look at and
get back with a more specific answer to you.
Senator Collins. I would appreciate that, and if you have
specific suggestions for statutory authority in any of these
areas, and I would say that to all three of the agencies
represented here, we really do want to work with you to give
you the tools that you need.
Another follow-up with you, Commissioner Kelly, on an issue
that was raised at our previous hearing. At our September 10
hearing there were a lot of coordination problems between
Customs and FDA that were discussed. For example, in the Port
of New York we found that the Customs Service was unaware of 63
FDA refusal notices.
Now, it would help, and I think this is something that
ought to be implemented, if FDA stamped the product ``refused
U.S. entry'' much the way FSIS does. At least then the importer
has to go to the trouble of repackaging it. I mean, at least we
are making it a little bit harder.
But it is troubling to me that there was that lack of
coordination, and in 48 of those 63 cases we are pretty certain
that the unsafe food actually entered into the American
marketplace. I know that in your written testimony you
suggested a possible solution to this problem, but I would like
to get that on the record.
Mr. Kelly. Yes, I think we need a lot more coordination
with the FDA. As a matter of fact, we have a meeting I believe
scheduled today. There is a lot of good things happening. There
is a joint task force, if you will, in Miami, where FDA and
Customs officers are working together. I think we will look to
replicate that where it is appropriate in other areas of the
country.
We are talking about a more effective interface between our
data systems, FDA's and the Customs' systems, that should
address the issue that you raised, and I am told that that will
hopefully be ready to go forward at the beginning of the
calendar year.
Senator Collins. And you are thinking of using FDA's
refusal as a redelivery notice for Customs?
Mr. Kelly. Correct.
Senator Collins. Is that a part of it, as well?
Mr. Kelly. That would cut down the time to implement the
penalty process, if you will. But it really is a duplicative
process now, and that is what we are looking to do, to use
their refusal notice as the notice for redelivery. Precisely.
Senator Collins. It seems like a good, practical
suggestion.
Dr. Miller, I just want to ask you one question before I
yield to my colleague, Senator Durbin. About the time that your
report came out, the President announced that he was forming
this coordinating committee. I realize that doesn't go as far
as what the National Academy's study has recommended, which is
similar to the approach that Senator Durbin is advocating. But
do you see this as a good first step, or what was the reaction
of your organization to the coordinating committee approach?
Dr. Miller. Well, since the committee had ceased its work
at the time when the announcement was made, the committee had
never--had not had the opportunity of evaluating it. So I can't
speak for the committee nor can I speak for the Academy, but if
you want a personal view----
Senator Collins. I would.
Dr. Miller [continuing]. The answer is yes. I think it is a
good--it is a first step, a small one, but a first step, and at
least it recognizes the realities of the current situation
concerning the interaction between the agencies.
Senator Collins. It strikes me that one possible option for
this Subcommittee to consider is codifying the coordinating
committee as sort of a middle ground between those who would
like a single food agency and those who are adamantly opposed
to any change in the current process. That is something that I
want to explore with Senator Durbin at some point.
I am going to yield to Senator Durbin. I asked the staff to
call to make sure that the vote is held for both of us. Senator
Durbin.
Senator Durbin. Dr. Miller, would you address this issue of
equivalency we have talked about here?
Dr. Miller. Yes.
Senator Durbin. I mean, the thing that comes to my mind is,
a lot of the contamination that we are talking about in
imported fruit and vegetables has a lot to do with sanitation
facilities in the fields. And if we were to say we are going to
demand a certain level standard, let's just address that one
aspect of the problem, would we be able to say that if you just
lived up to the standards that we impose on growers in the
United States, that that would meet the safe level in terms of
health and the like?
Dr. Miller. Yes, that is a very interesting question. The
committee, in discussing this issue of equivalency, in our
discussions, and it didn't show up in the report per se, but we
all understood that when you talk about equivalent you don't
mean identical. It means that the outcome is the same.
And different countries have different problems. For
example, in terms of water, in some countries of the world you
can rest assured that what you are not going to have is, in
fact, clean water. In the United States, on the whole, you can
be pretty well assured you can.
So you have to set up different ways of approaching it. The
only way to assure yourself of this is that what comes out the
other end is the same, and that you have identified where the
problems are and you do something to deal with it, and
sanitation is the basic thing.
Senator Durbin. What I am asking about is the threshold
that we have established in the United States for sanitation,
just to take that, when it comes to workers in the fields
harvesting fruit and vegetables. If we were to say, ``All
right, if the rest of the world lives up to this standard,''
then at least that concern wouldn't be on the table?
Dr. Miller. Oh, right. We certainly can't ask other
countries to do better than we do ourselves.
Senator Durbin. No, but let's say if we asked them--what I
am getting at----
Dr. Miller. We have got standards.
Senator Durbin [continuing]. Do we have a standard that is
good enough now for the National Academy of Sciences to say,
``If the rest of the world followed this,'' that would at least
allay some of our fears?
Dr. Miller. As a general rule, yes. I mean, there are
always exceptions. One thing the scientific community can
always do is find things wrong with things, and there are
things that could be made better, and there is no question
about it. But I think, on the whole, I think you have to say
that the food supply that is supplied to the American people is
pretty safe, and that is because the standards we use are
enforceable standards and the products that we turn out are
safe.
Senator Durbin. Well, I am glad you said that, because it
goes back to the Chair's question, concerns expressed to her
about if we are going to call for equivalency, does that mean
higher standards for the United States? And I think your answer
is that if other countries could come close to meeting our
standards, that it would solve some of the problems here.
Dr. Miller. I can only make, if I may, just one further
recommendation to the Subcommittee, if I can. We have
concentrated and we seem to be focused entirely on the issue of
pathogens in food, and correctly so. That is the most recent
problem, and it is one which in part has come about because we
focused for so many years on the chemical components of food,
chemical contamination, and food additives.
Since I have been talking about this for many years, as my
colleagues know, arguing that we haven't paid enough attention
to pathogens, I find myself in the unenviable position of
having to say, ``Now, wait a minute, let's not forget about the
other part of it, too. In our efforts to deal with pathogens,
let's not do what we did to them in the first place, and stop
doing the things that assure us safe food in terms of
chemistry.''
So I would simply suggest that in any legislation you
consider, you think about food safety in its broadest context,
not just in terms of pathogens.
Senator Durbin. Thank you, Dr. Miller. I have another line
of questions but we won't have time for it, because I would
like to walk through with the FDA exactly what is happening at
those ports of entry. Since I saw it a few years ago, I would
like to figure out whether it has changed. I hope it has in the
meantime.
But thank you all for your testimony. Thank you, Madam
Chair.
Senator Collins. Thank you very much Senator. Again, my
thanks to all the witnesses today. This will be an ongoing
dialogue. All of us who are so interested in this issue look
forward to working with you in the coming months to put
together comprehensive legislation on the area of food safety.
It is an area that Senator Durbin has done a great deal of work
on, and I look forward to joining with him as well as our other
colleagues and all of you.
We will continue looking at the remedy stage of this
problem in a hearing that will be held tomorrow at 9:30 a.m. in
this room. Again, my thanks to all of you. I look forward to
working with you. And I thank the staff for its excellent work
in this area. The hearing will stand adjourned. Thank you.
[Whereupon, at 12:28 p.m., the Subcommittee was adjourned
to reconvene at 9:30 a.m. on Friday, September 25, 1998.]
IMPROVING THE SAFETY OF FOOD IMPORTS--PART IV
----------
FRIDAY, SEPTEMBER 25, 1998
U.S. Senate,
Permanent Subcommittee on investigations,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 9:30 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Susan M.
Collins, Chairman of the Subcommittee, presiding.
Present: Senators Collins and Durbin.
Staff Present: Timothy J. Shea, Chief Counsel/Staff
Director; Mary D. Robertson, Chief Clerk; Christopher A. Ford,
Senior Counsel; Mary G. Mitschow, Counsel; Don Mullinax, Chief
Investigator; Kirk E. Walder, Investigator; Stephanie A. Smith,
Investigator; Lindsey E. Ledwin, Staff Assistant; Pamela
Marple, Minority Chief Counsel; Beth Stein, Counsel to the
Minority; Marianne Upton (Senator Durbin); and Beth Fitzpatrick
(Senator Lieberman).
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. The Subcommittee will please come to
order. Good morning.
Today, the Permanent Subcommittee on Investigations is
convening its last in a series of five hearings on improving
the safety of imported foods. As I noted yesterday, the focus
of this phase of our food safety investigation is on exploring
ways to correct the deficiencies in the food import system.
Yesterday, we heard from the Federal agencies responsible
for the safety of imported food and from a representative of
the National Academy of Sciences. The Food and Drug
Administration, the Food Safety and Inspection Service, and the
U.S. Customs Service announced several reforms that they plan
in response to the problems revealed by this Subcommittee's
investigation. I welcome these positive first steps and look
forward to the additional administrative improvements, as well
as these agencies' specific recommendations for statutory
changes.
As critical as their roles are, government agencies alone
cannot provide comprehensive solutions to the problems that
plague our food import system. The private sector--from
producers to distributors to retailers to consumers--must also
be part of any effective program to improve the food safety
net.
Americans depend on imports to enrich their diets,
especially in areas of the country with short growing seasons,
such as my State of Maine. In order for American families to
take advantage of the benefits of consuming five servings of
fruit and vegetables a day that have been recommended by the
National Cancer Institute and other experts, our food must be
safe and affordable. Food safety programs in the United States,
in other words, must be effective and comprehensive, but they
must not erect needless barriers to impede the import of safe
and wholesome foods. The challenge facing us is to strengthen
our import system so that tainted products do not reach our
dinner plates without stopping the importation of foods that
Americans enjoy.
Accordingly, we will hear today from representatives of a
number of private groups--industry associations, consumer
groups, scientists, and other experts--who have devoted much
study to improving our food safety system. It is my hope and
expectation that the wisdom and experience of such non-
government stakeholders, combined with that of the government
agencies from which we heard yesterday, will help this
Subcommittee craft comprehensive legislation to improve the
safety of imported food.
It is my expectation that such legislation would be
introduced early in the next Congress.
My goals are to help ensure that food safety programs are
effectively managed, that existing resources are focused on
those imports posing the greatest risk of harm to Americans,
and that deficiencies in the underlying regulations and laws
are remedied.
To this end, we have asked eight industry and consumer
organizations to participate in today's hearing. We will hear
from the Food Marketing Institute, the Grocery Manufacturers of
America, the National Food Processors Association, the United
Fresh Fruit and Vegetable Association, the American Public
Health Association, the Safe Food Coalition, the American
Council on Science and Health, and Public Voice for Food and
Health Policy.
I look forward to hearing from our diverse witnesses today
and to discussing their ideas on how we can strengthen our food
import safety system so that Americans can continue to enjoy a
variety of safe and nutritious foods from around the world.
In putting together our witness list today, we attempted to
invite groups representing a wide variety of views. There are,
however, I have learned, many, many organizations involved in
this issue. Due to time constraints, we are not able to
accommodate everyone who wished to testify this morning.
However, I have sent letters to as many groups as seem to be
interested, inviting them to provide written statements for the
Subcommittee's consideration. And if there are any other groups
that we have forgotten, who are represented today in the
audience, we would also invite your input by submitting a
written statement.
Without objection, the hearing record will be left open for
10 days, so that all such statements may be included in the
printed hearing record and our witnesses have the opportunity
to submit any additional information requested by the
Subcommittee for the record.
I would now like to call forward our first panel of
witnesses. They include representatives of groups associated
with various aspects of the food production and food services
industries. These witnesses will give us private-sector
recommendations for improving the safety of food imports.
Timothy Hammonds is the president and CEO of the Food
Marketing Institute, a 1,500-member association representing
food retailers and wholesalers and their customers in the
United States and around the world.
Dr. Stacey A. Zawel is the director of Scientific and
Regulatory Affairs for the Grocery Manufacturers of America.
GMA is the world's largest association of food, beverage, and
consumer brand companies.
Dane Bernard is the vice president for Food Safety Programs
at the National Food Processors Association. NFPA members
process and package fruit, vegetables, meat, fish, and special
food and beverage products.
Dr. Nancy Nagle is here representing the United Fresh Fruit
and Vegetable Association. This is a National Trade Association
with over 1,100 members that represents the interests of
producers, wholesalers, distributors, brokers, and processors
of commercial quantities of fresh fruit and vegetables.
Pursuant to Rule 6, now that you are all comfortably
seated, I will ask that you stand and raise your right hand so
you can be sworn in.
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?
Mr. Hammonds. I do.
Mr. Bernard. I do.
Mr. Zawel. I do.
Ms. Nagle. I do.
Senator Collins. Thank you. Given the wide range and number
of witnesses that we have today, I am going to ask that you try
to confine your oral presentation to about 5 minutes. If you
need a couple of minutes extra to conclude your thoughts, feel
free to take them.
Your written testimony in its entirety will, however, be
submitted for the record. The lights in front of you will cue
you as to the amount of time left. When you have 1 minute left,
the yellow light will come on, and then when you see the red
light, if you could try to wrap up in the next moment or two.
Mr. Hammonds, we are going to start with you. Please
proceed.
TESTIMONY OF TIMOTHY M. HAMMONDS,\1\ PRESIDENT AND CEO, FOOD
MARKETING INSTITUTE
Mr. Hammonds. Thank you, and good morning, Madam
Chairwoman. I am pleased to testify for you here today. This is
an important issue, and we are very happy to have a chance to
express our views. Thank you also for letting us submit our
full written testimony, and I will summarize for you.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Hammonds appears in the Appendix
on page 188.
---------------------------------------------------------------------------
Let me start by commending you and the Subcommittee for
your investigation of the adequacy of government programs to
ensure that imported foods are safe. We feel that is a timely
inquiry and we welcome it. FMI has a long history of working
closely on food safety issues with FDA, USDA, and foreign
countries that both import agricultural products and export
commodities to us year round.
In fact, I am very pleased to see that Senator Coverdell
mentioned in his testimony before this Subcommittee FMI's
cooperative effort was carried out with FDA and the country of
Guatemala to develop a model plan of excellence to bring their
raspberries back into our domestic markets. We are very proud
of that program.
Based on our experience, we believe produce imported into
the United States is safe, nutritious, and healthy. Yet, your
hearings have identified shortcomings in the Federal system for
inspecting imported produce, specifically that FDA lacks
sufficient resources to give consumers the level of protection
they expect. The agency itself has acknowledged these
shortcomings. The National Academy of Sciences reached the same
conclusion in their report: Ensuring Safe Food From Production
to Consumption.
Now that you have identified some problems, let us turn to
what we feel might be solutions. The recommendations of the
Academy, the President's Food Safety Initiative, and the
General Accounting Office provide an excellent framework for
improving the inspection system and making better use of
existing government resources. Let me point out up front that
FMI believes these reforms can be made without costing
taxpayers additional dollars and without additional user fees.
First, let us focus just briefly on how we might improve
the inspection system. Clearly, the emphasis should be on
prevention; that is, keeping contaminated produce from ever
entering a country. My written testimony sets forth six basic
components of an effective control system. These include a
system to evaluate the food safety programs of countries that
export produce to America to ensure equivalency with U.S.
standards and Federal authority to reject produce shipments
from countries with inadequate food safety controls for their
exports to the United States.
But regardless of the exact nature of the system put in
place, one critical resource need must be addressed. Additional
personnel will be needed for inspection and monitoring at our
ports of entry. FMI believes this critical need for additional
personnel can be met by redeploying to ports of entry existing
FSIS in-plant inspectors freed from their current duties by the
modern HACCP-based inspection system being put in place for
meat and poultry.
We feel there is no question that inspectors will be
available. When the new HACCP system is in place, FSIS will no
longer need its current complement of inspectors. This will
free up thousands of staff hours for use in other areas of food
safety. FSIS has not yet evaluated the risks throughout the
food system to determine where those resources could best be
used to prevent contaminated foods from reaching the consumer.
However, your hearings have identified precisely where these
resources would be most effective, and that is at our points of
entry for imported foods.
FMI believes this redeployment can easily be accomplished
in several ways. First, and perhaps most easily, a cross-
utilization program between FSIS and FDA. Such a program would
allow them to share resources for inspecting imported produce
and seafood. The President has already asked his new Council on
Food Safety to develop a coordinated budget for the agencies
that regulate food safety. The creation of this council,
complimented by the work of your Subcommittee and others in
Congress, sets the stage for such a cross-utilization program.
However, should such a program not prove feasible, we could
meet the same goal by transferring statutory authority for
inspecting imported produce from FDA to USDA or by transferring
FSIS inspectors to FDA for reassignment to ports of entry. In
our view, a cooperative agreement between the agencies would be
far superior to either of these alternatives.
Almost all of the other proposals for improving the safety
of imported foods that we have heard require additional tax
dollars. Fortunately, the resources and expertise needed to
implement this plan that we have outlined already exists within
the Federal Government. It is simply a matter of coordinating
resources among the affected agencies or, if necessary,
redefining responsibilities, as directed by Congress. As a
result, the approaches I have outlined would be revenue
neutral.
We know this proposal could meet with resistance from both
within the government, as well as from industry. Debate is, of
course, a part of our natural public policy process. However,
debate that fails to reach a constructive conclusion serves no
one's interest. As these issues play out in the media, they
serve only if continued to raise concerns in the mind of
consumers.
The Subcommittee, under your leadership, has raised
awareness of the shortcomings of our inspection system for
imported foods, and we feel it is now time to move on to a
resolution of these problems.
Thank you, Madam Chairwoman, and Members of your
Subcommittee for the opportunity to speak with you today on
behalf of the members of the Food Marketing Institute.
Senator Collins. Thank you very much, Mr. Hammonds. As
occurred yesterday, we unfortunately are in the middle of a
vote. So I am going to have to recess the hearing for 10
minutes while I go vote. So we will stand in recess for 10
minutes. My hope is this will be the only interruption we have
this morning.
[Recess.]
Senator Collins. The Subcommittee will resume. I would now
like to call on Dr. Stacey Zawel for her comments. If I have
mispronounced your last name, please feel free to correct me.
TESTIMONY OF STACEY ZAWEL,\1\ Ph.D., DIRECTOR, SCIENTIFIC AND
REGULATORY AFFAIRS, GROCERY MANUFACTURERS OF AMERICA
Ms. Zawel. Thank you, Senator, and good morning. My name is
Stacey Zawel, and I am the director of Scientific and
Regulatory Affairs for the Grocery Manufacturers of America.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Zawel appears in the Appendix on
page 194.
---------------------------------------------------------------------------
Today, I would like to talk about the U.S. food supply,
which remains the safest and most abundant in the world. Though
we are very concerned about imperfections in the system, we
should not lose sight of the fact that American consumers
safely enjoy more than 750 million meals every day. GMA and the
food industry have a great deal at stake in ensuring the safety
of our products, and we take this responsibility very
seriously.
While the primary responsibility of producing safe food
lies with the food industry, FDA and USDA work in cooperation
with us to help ensure the safety of our domestic food supply.
These agencies must also serve as guardians of the health and
welfare of all Americans, especially with regard to the
regulation of food imported into the United States. However, to
do this, FDA needs no further authority to enforce the law.
Imported food is subject to requirements intended to ensure
that food is safe, whatever its origin.
Although the Federal Food, Drug, and Cosmetic Act provides
FDA with no foreign inspection authority, it does authorize FDA
to refuse admission to articles, including foods, that appear
to be adulterated or misbranded or that have been manufactured
under unsanitary conditions.
The Secretary of Health and Human Services also has the
authority to refuse entry to foods that are illegal or subject
to restrictions in the country in which they were produced or
from which they were exported.
To streamline its import monitoring activities, FDA
routinely issues import alerts to its district offices. These
alerts identify products and importers that have repeatedly
violated Federal law. However, inspection at ports is only one
part of a multifaceted strategy to assure that only safe foods
are imported into the United States.
To the extent port-of-entry operations can be improved
through better management and resource allocation, we would
support that effort. It is very important to recognize that
inspection alone does not make food safe. In short, we cannot
inspect our way to food safety.
GMA believes that the system and scope of FDA authority,
parts of which I have described, are fundamentally sound.
Rather than merely expanding inspection authority, GMA
recommends three steps we believe will more effectively address
those food safety concerns, preventing the most significant
risk to public health.
First, research must be conducted to identify foodborne
hazards and habitats. Second, resources must be allocated to
the appropriate prevention programs and, finally, leadership
must be asserted in the international standard-setting arena.
Now I would like to expand on each of these areas. First,
the agency's responsibility for food regulation must be
provided with the means necessary for essential scientific
expertise and research. We have to identify and fight true
causes of foodborne illness with the right scientific weapons,
which can only be discovered through laboratory research and
practical testing.
Without proper research supporting our food safety system,
regulators will not be able to keep pace with today's
manufacturing processes. An effective and credible science-
based system complimenting food manufacturers' own safety
assessment programs provide consumers with the greatest
assurance possible that their food is safe.
Second, the Federal agencies overseeing the food supply
need appropriate resources. That means money for scientists,
investigators, state-of-the-art scientific and technological
tools, and modern, well-equipped facilities.
Consumers are best served by strong food safety agencies
that develop policy based on the best science to build public
confidence in the safety of the Nation's food supply. With
adequate resources appropriately applied, they will be able to
respond to changing dynamics of food safety in a creative and
effective manner.
Finally, we must assert strong government leadership in the
global arena to stay on course and develop solutions to real
food safety problems. Congress needs to provide funding and
encouragement to both FDA and USDA to play a more active and
influential role at international meetings such as in the Codex
Alimentarius.
This means three things: It means supporting workshops
prior to Codex meetings to educate our trading partners,
especially those in developing countries; it means supporting
the personnel needed to coordinate U.S. delegation activities;
and, finally, it means building coalitions with other countries
who participate in Codex to hasten the process of improving
food safety systems worldwide.
The steps I have outlined may seem simple, but they are not
simplistic. They require action that is based on science and
common sense. GMA stands ready to assist Congress in any way
that we can to help further enhance the safety of the food
supply in the United States and throughout the world.
Thank you for the opportunity to testify today.
Senator Collins. Thank you very much.
Mr. Bernard.
TESTIMONY OF DANE T. BERNARD,\1\ VICE PRESIDENT, FOOD SAFETY
PROGRAMS, NATIONAL FOOD PROCESSORS ASSOCIATION
Mr. Bernard. Thank you, Madam Chairman, and thank you for
the opportunity to be here and provide comments. Thank you for
your personal leadership in this issue. I am Dane Bernard, vice
president, Food Safety Programs for the National Food
Processors Association.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Bernard appears in the Appendix
on page 196.
---------------------------------------------------------------------------
To put our comments into context, I would like to make two
preliminary observations, if I may. First, the data on
foodborne illnesses do not support claims that imports are
inherently less safe than foods produced domestically. Still,
we feel that some changes in our system of assuring the safety
of imported foods is warranted and NFPA will be pleased to lend
its support in identifying appropriate strategies for change.
Second, NFPA does not agree with the impression left by
some who have testified that safety of imports is solely the
responsibility of the Federal Government. American food
companies are not poised with their arms spread wide ready to
accept bad product. We have nothing to gain and much to lose in
our reputations, our customers, and our sales by such a
strategy.
The majority of U.S. food processors know and have
confidence in their international growers, producers, and
suppliers. U.S. companies conduct more tests, inspect more
foreign establishments, visit more growing areas, and provide
more information to suppliers than the government could ever
do.
America's food processors are very much a part of the food
safety-net. Working from this perspective, NFPA supports
policies that concentrate on whether food is safe, not on its
origins. NFPA maintains that imported foods should be as safe
as those produced domestically and NFPA affirms that these
foods must meet all relevant U.S. public health standards.
To achieve these goals, we recommend that the United States
reach accords with other nations or regions, which rely on
determinations of equivalency based on the best scientific
information and the application of risk analysis techniques.
These accords should be based on achievement of appropriate
levels of consumer protection through application of
performance criteria which can be verified by U.S. food
companies and government authorities. Since the definition of
``equivalent'' or ``equivalency'' are critical to what comes
next, we should note that, according to Black's Law Dictionary,
they mean just what the word ``equivalent'' says; equal in
value, force, measure, volume, power, and effect or having
equal or corresponding import, meaning or significance. In
other words ``equivalent'' and ``equivalency'' do not
necessarily mean identical and are not ``the same as,'' except
in the end result.
And I emphasize Dr. Miller's testimony from yesterday,
which focused on outcomes of food safety rather than the
elements of the system that produced the food.
Now that I have covered a few basics of the NFPA position,
I would like to address some specific points from the GAO
report. The report recommends that the Federal Government
reduce its emphasis and reliance on end-product testing to
verify food safety and, instead, promote systems that prevent
contamination from occurring in the first place. We fully agree
with this conclusion.
As I mentioned a few moments ago, we also agree that all
imported foods should be produced under equivalent, not
necessarily identical, food safety systems. NFPA cannot
endorse, however, legislation that would require other nations
to adopt our exact procedures and certainly cannot in any way
condone the mandatory imposition of methods that are the same
as those in the United States unless no other methods exist to
ensure an equivalent level of protection.
To realize these ends, NFPA believes the superior route
follows international accords like bilateral Equivalence
Agreements, Memoranda of Understanding, Mutual Recognition
Agreements, and similar avenues. Voluntary agreements promote
cooperation and food safety; mandates only invite retaliation.
When we say ``equivalent'' or ``equivalency,'' we are
talking about looking at the entirety of the plan, the design
of the plan. Determinations of equivalence must be based on the
best science available, including the application of risk
analysis techniques as appropriate to the situation.
Producers must still complete the circle by following
appropriate methods, and the country or region of origin must
enforce the scheme. For our part, industry and government, we
need to trust, but verify. Within this construct, random,
relatively frequent end-product testing may come into play
until a record of consistent compliance is established, at
which time end-product testing would taper off to periodic,
unannounced examinations. The same would apply to inspections
in foreign countries under a Memorandum of Understanding or
other voluntary accord.
Regarding importing firms, FDA could establish a ``three
strikes you are out'' regulatory threshold where importers with
multiple safety-related violations would be targeted for
frequent and rigorous inspection, if not out-and-out denial of
entry.
For repeat offenders in this category, a permit system
could be instituted which stipulates augmented checks on
imported food products, much like the FDA's domestic program
for producers of canned goods. Bad actors would have to obtain
a permit, in other words, from the appropriate agency before
they could bring products into the United States and permits
would be granted only after the safety of the goods are
verified. A ``need for permit'' classification would terminate
only after the importer re-establishes an appropriate level of
trust.
Whether under the current scheme or some other arrangement,
the FDA, along with customers, must seize greater control over
our borders and ports, especially when repeat offenders are
uncovered. Allowing rejected products to re-enter at another
port cannot be tolerated. Noncomplying imports must be marked
or otherwise identified so that end runs fail and those
attempting such fraud are dealt with swiftly and effectively.
U.S. authorities must also prioritize infractions and
responses according to the risks they pose. The GAO report
often cited the example of the Food Safety and Inspection
Service ranking incorrect labeling that is not health related
on the same par as true health-threatening infractions. This is
a ludicrous practice. At the very least, this example displays
a disturbing disregard for employing our food safety dollars to
their fullest effect.
Finally, the GAO report hints at an accreditation system
for laboratories to permit independent food testing by third
parties. While the concept has merit, accreditation programs
are expensive to establish and maintain. Applying a ``three
strikes and you are out'' system based on random FDA sampling
to verify accuracy, compliance, and performance could achieve
similar results. Rather than producing a list of accredited
labs, FDA could identify those labs that do not produce
adequate results.
We agree with earlier comments that additional resources
will be needed to further enhance our ability to address
potentially contaminated imports. In the near future, resources
will be needed to establish Memoranda of Understanding with
exporting companies; to verify the accuracy of importer-
provided shipping information; and to move repeat offenders
from eligibility for the simplified electronic filing to a more
intense regulatory strategy.
Also, as suggested by the GAO report, the Food Safety and
Inspection Service should modify its automated import
information system so that food safety infractions, high-risk
products, and unsatisfactory importers can be quickly and
accurately identified.
On the need for legislation, NFPA respectfully submits that
any legislative initiative, like the Safety of Imported Food
Act, should evolve deliberately. We maintain that the FDA
already has the statutory authority to make the changes through
regulation that the GAO and others have suggested.
To confirm and clarify what legislation is needed and not
needed and as a first step towards coordinating legislative and
regulatory initiatives, we recommend FDA outline for the
Subcommittee the problems the agency has identified, their
current authority to correct those situations, and what
regulations it foresees proposing to improve the safety of
imported foods.
After receiving FDA's analysis, if legislators, regulators,
industry advocates, and food scientists reach a consensus on
food safety policy and the FDA demonstrates that legislation is
needed, then we should proceed to do so. Our concern is that we
have taken a preliminary fire-ready-aim approach in our current
proposals that may not produce the most desirable end results.
Madam Chairman, Members of the Subcommittee, this concludes
my testimony. I will look forward to your questions.
Senator Collins. Thank you, Mr. Bernard.
Before calling on our final witness on this panel, I want
to call upon Senator Durbin to see if he has any opening
comments he wishes to make.
Senator Durbin. None at this time. Thank you.
Senator Collins. Thank you.
Dr. Nagle, you may proceed. Thank you.
TESTIMONY OF NANCY NAGLE,\1\ Ph.D., SENIOR ADVISOR FOR FOOD
SAFETY, UNITED FRESH FRUIT AND VEGETABLE ASSOCIATION
Ms. Nagle. Chairman Collins, thank you for the opportunity
to testify this morning. I am Nancy Nagle, Senior Adviser for
Food Safety for the United Fresh Fruit and Vegetable
Association, and I would like to summarize our written
testimony.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Nagle appears in the Appendix on
page 210.
---------------------------------------------------------------------------
I want to remind everyone at the outset of my testimony
just how safe fruit and vegetables really are. Of the 3,200
foodborne illness outbreaks reported by CDC from 1986 to 1996,
only 31 were related to fresh fruit and vegetables. There is
also no definitive data that exists that implies imported
produce is a greater risk than domestic.
Your first question was what are the deficiencies in the
current food-import process and what can be done to address
these problems. In the General Accounting Office's April 1998
report on food safety, they determined that a reliance on port-
of-entry inspections cannot provide complete assurance of
safety of imported foods. However, we are unaware of incidents
of port shopping or other enforcement problems occurring with
fresh produce.
It is widely accepted among food safety professionals that
the prevention of microbial hazards is far more effective than
trying to ascertain and identify and verify the safety of foods
after it has been produced and handled. United believes that
FDA has ample authority to work proactively with foreign
growers, packers, and shippers of fresh fruit and vegetables
and their respective governments to prevent food safety
problems.
FDA's recent experience in Guatemala confirms the
possibility of proactive, cooperative actions in foreign
countries to address food safety concerns, but the agency must
have the necessary resources to do the job.
United believes that the Federal Food, Drug, and Cosmetic
Act provides ample existing authority to FDA to deny the
importation of unsafe fresh fruit and vegetables. FDA may
refuse admission of food offered for import if it appears, from
an examination or otherwise, that a food is adulterated,
misbranded, or has been manufactured, processed or packed under
unsanitary conditions.
The Act grants FDA the authority to take enforcement action
against an imported food based upon far less evidence than is
required for the same action against a domestically produced
food. FDA need only to determine that an imported food appears
to violate the Act. I have attached a more complete description
of this authority to the written testimony we submitted.
The greatest constraint to FDA's food safety activities is
the lack of resources. The GAO's April 1998 report on food
safety describes a situation where imported food entries are
increasing at a substantial rate, while FDA's capacity to
inspect is declining. We believe that Congress should focus its
attention on the underlying issue of resources rather than
expanding the agency's statutory authority.
The second question posed by the Subcommittee is: Can
regulatory agencies better use their existing regulatory
authority to improve the safety of imported food?
In addition to using its automatic detention authority when
needed, FDA should pursue three important opportunities to
increase the certainty of safe imported foods. These
opportunities are the publication of the FDA guidance document
to minimize and prevent microbial hazards in produce and the
international dissemination of this document; the publication
of guidance on the criteria FDA intends to use to evaluate
whether or not a regulatory system used by a foreign country to
ensure the safety of food is equivalent to the United States;
and the pursuit of internationally recognized standards set by
Codex Alimentarius for the hygienic production and handling of
fresh fruit and vegetables. I elaborate on each of these points
in our written testimony.
Finally, the last question posed by the Subcommittee is
what other recommendations should be considered to improve the
food import process. I encourage the dissemination of the
guidance document on good agricultural practices to as broad
and multinational an audience as possible. There have also been
discussions with various aid and lending agencies to encourage
them to support the development of laboratories and other
public health infrastructure. If there is greater confidence in
the safety of products from a given area, there can also be
economic benefits that accompany such confidence. We have also
discussed the imported food safety legislation in our written
testimony in more detail.
In conclusion, the United Fresh Fruit and Vegetable
Association is eager to participate in any responsible effort
to enhance the safety of our Nation's food supply. We recognize
that foodborne illness is a serious issue, but we do not
believe that giving FDA additional regulatory authority in lieu
of needed resources is the appropriate response.
Thank you for this opportunity to testify, and I will be
pleased to answer any questions you or other Members of the
Subcommittee may have.
Senator Collins. Thank you, Dr. Nagle. I do want to start
with you to clarify an issue, and you look so happy about it.
[Laughter.]
You have testified today that your organization does not
support additional authority for the FDA. You do not support
proposals for so-called equivalency. Is that opposition based
in fears of your members that if FDA moves to an equivalency
standard, that it will result in increased regulation for
domestic producers?
Ms. Nagle. It is actually more of a concern that we will
not be importing foods at all. One of the things is, depending
on whether we define equivalency in a legal manner or in more
of a scientific manner, if we look at some of the proposed, or
talking about regulations and laws within other countries, we
believe that, since we are the top tier in regulations, we
could end up with not being able to import food from other
countries, where they can produce perfectly safe food, but not
necessarily as dictated by their government regulations.
An example would be that if a country does not have the
appropriate chlorination systems for their water supplies
within their cities or within their municipalities, but a given
company that may be producing in that country is doing, is
chlorinating their water that is used to wash melons or for
their processing, so we do not want blanket disapproval of a
country, where there can be definitely safe food coming from
that area.
Senator Collins. Does your organization think that the
equivalency approach that is used for imported meat, poultry,
and eggs has worked well or do you have concerns about that
also?
Ms. Nagle. I think I need to talk a little bit more with
our legal people there, but we do have some concerns that we
could end up precluding imports that would be perfectly safe.
Senator Collins. I do not think anyone wants that result
and, in fact, I said in my opening statement that I think that
is the challenge, is to devise a system that can deal with the
fact that we have emerging pathogens to which American
consumers are very vulnerable, even if a local indigenous
population may have built up immunity to it, that are difficult
or impossible to detect through a border port-of-entry
inspection.
The reason I raise the issue with you is, in my questions
of FDA yesterday, I specifically asked whether FDA officials
felt that if we moved to some sort of equivalency system it
would result in a whole new layer of regulation for domestic
producers because that is not something I want to see. FDA
officials were pretty reassuring on that point.
It seems to me that it is in the interests of domestic
producers, as well as foreign producers, to have a better
system to ensure the safety of food imports; indeed, the safety
of all food, because we have had testimony and evidence given
to us that consumers do not distinguish as to the origin of
fruit that has become suspect. For example, I have been told
that when the Guatemalan raspberry incident occurred, which
resulted in thousands of people becoming ill with foodborne
illnesses, that people stopped buying raspberries, period.
So it seems to me that it is not in the interests of
domestic producers to have tainted fruit come into this
country.
Ms. Nagle. We agree. I have a statement on equivalency that
perhaps I could read for us here. I think you have touched upon
an important point. I think it is very important that FDA
finalize its criteria for determining equivalency.
The agency has the authority to do so, and it would seem to
be an important step in allocating inspection resources to the
areas that most need it. Beyond the FDA guidance document, we
need to be very clear about what equivalency means. I can tell
you that, as a food safety professional, there are certain
fundamental principles about sanitation that should be
universally followed when producing and handling food.
Food consumed in the United States should be produced under
these minimum acceptable standards of sanitation, and if that
is equivalency, we support equivalency. But if the term is used
too broadly in a legal sense, then we could have very
significant disruptions. The fact of the matter is that the
United States has a set of food safety standards, a regulatory
system, and a public health infrastructure that places us in
the very top tier of all countries.
If what is meant by equivalency is that countries in
Central America, South America, Africa, and Asia are to have
systems like ours, then we will not be importing food. People
need to understand that we can import safe food from countries
that otherwise have poor water quality, inadequate sewage
treatment, and a general lack of refrigeration. The reason that
this is possible is because those operations that export to the
United States use good-quality water, have in place good field
sanitation, and use refrigeration.
The fact that a Central American Government may not
adequately chlorinate a municipal water supply, does not mean
that a melon grower or shipper does not chlorinate, does not
have latrines for their workers or that the melons do not have
chlorinated roots prior to packing.
We are very concerned that a legal concept of equivalency
may be unrealistic, and applied too broadly, and bar the
importation of safe food.
Senator Collins. Your testimony indicates that, if we go
with this approach, we do need to be very careful how we draft
the legislation.
Ms. Nagle. Right.
Senator Collins. Your point is similar to one raised by Mr.
Bernard, and I just want to clarify for the record that I do
not know anyone who is saying that ``equivalency'' means
``identical.'' It clearly does not. It does not mean ``same.''
It means ``equivalent.'' That is very different. I just want
to, for the record, state that because you expressed concern
that it might be interpreted to mean ``identical'' standards to
the United States, and I do not know anyone who is advocating
that.
You also mentioned, and I think an obvious fact, that your
members are not opening their arms wide, I think you said, to
welcome tainted fruit. I think that is another obvious
statement. On the other hand, tainted products is coming into
the United States. We have had two cases in which thousands of
people were sickened with the Guatemalan raspberries and also
the hepatitis-contaminated frozen strawberries from Mexico. So
this is not a theoretical problem.
Now, I agree with you that the private sector has a very
important role to play, and you mentioned that your members
actually do inspections, which I commend you for. What actions
do you take when you discover a contaminated, unsanitary farm
in another country or you discover an unscrupulous importer was
trying to pass off tainted fruit or vegetables or other food to
you? Do you report that to the FDA or to FSIS or to the Customs
Service?
Mr. Bernard. Thank you for your question. The typical
response would be immediate rejection of the product, and
usually that happens before it even exits the country of
origin. If, for example, poor conditions exist in a growing
area or a potential vendor of product that wishes to sell to
the U.S. customer, if the auditors on-site decide that that is
not someone they want to buy from, it is a market decision.
They simply refuse that product.
If there is a consistent problem at port of entry,
typically the concept would be to send the product back. It is
not out of the question that someone would report that to the
government, and that does happen. To give you a conclusive
answer to say that that always happens, I am sure I cannot do
that.
But if I might go back to the issue of equivalence.
Conceptually, I think everybody agrees with the definition of
the word, that it does not mean ``same as.'' But you referred
to the FSIS system earlier, and the GAO report repeatedly
refers to the FSIS system.
Because we do not know the exact level of protection that
the sanitary measures that that system utilizes, what we end up
doing is looking at the way you do it and the way we do it and
coming out with a qualitative judgment that says, ``Well, we
think it is about the same,'' and what you end up with is
looking at the elements of what we classify as process-based
standards; we do it this way, you do it this way. Rather than
looking at the level of consumer protection that each process
brings to the food. That should be the prime target, and not
exactly how you get there.
So I know conceptually we are all talking about equivalence
not being the same, but we have not yet determined, on a
Federal policy basis, what we mean by equivalence, how we will
determine equivalence, and how to go about establishing it
within countries or regions that we might want to trade with.
So I would say, as a top-line recommendation, that we need to
start there with getting our agencies to state their positions
and explain the logic. Next, we need to get away from just the
logic to the machinery as to how that is going to happen and
start filling in some of the blanks and the details of how we
are going to go about doing determining equivalence. Thank you.
Senator Collins. My time has expired for this round, but I
do want to pursue more of these issues with you.
Senator Durbin.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Thank you, Madam Chair. On behalf of our
colleague, Senator Glenn, who could not make it here today, if
there is anyone in America who does not know why he is absent
today, I will remind them he is preparing for the launch
October 29 back into space. But he wanted to commend Chairman
Collins for her leadership on this issue and her leadership of
the Subcommittee during the session and requests that the
record of today's hearing remain open so that he may include a
written statement on this important issue.
Senator Collins. Thank you.
Senator Durbin. Thank you. First, I would like to ask a
fairly general question, very leading I might add, that betrays
my prejudice on this issue, and let me just see what kind of
response I get from the panel here.
I would like to ask each of you to respond to this
question: Do you believe that dividing jurisdiction for safe
food inspection in America among at least six different Federal
agencies governed by 35 different laws makes our food supply
safer, makes obeying the law easier for your members, or serves
the taxpayers' needs to avoid added costs of duplication?
Mr. Bernard.
Mr. Bernard. Thank you, Senator.
The responses that were given yesterday to a similar
question, I think, would be our response. Is the current system
the optimal system if we are going to design a new system?
Obviously, not. I think that the American consumers, industry,
and the agencies involved have done a remarkable job in the
face of such a confusing system of bringing about a very safe
food supply.
We, as well as the agencies who testified yesterday, are
awaiting the results of further study. Our organization has
continually voiced concern for coordination, in whatever way
can be achieved, and we look forward to the further study on
the issue.
Thank you.
Senator Durbin. Mr. Hammonds.
Mr. Hammonds. Good morning, Senator.
Senator Durbin. Good morning.
Mr. Hammonds. Thank you for your question. Clearly, we feel
that better coordination at a minimum is necessary. As grocers,
we are dealing directly with consumers, and perhaps the
difficulties surface in the way that is easiest to understand
if we think about a time of crisis. Often when there is a food-
safety emergency of whatever source, the grocers are the ones
that find the TV cameras show up and the reporters are asking
questions, and it, when jurisdiction is split, can be very
difficult to find a government spokesman willing to come out
quickly and reassure the public and establish the exact
parameters of the situation we are dealing with.
So, in general, we feel, at a minimum, better coordination
is necessary. And certainly we feel that there ought to be a
system in place where, in times of an emergency, there is an
easy, quick way to find a government spokesman who can
reassure, not only the people in the industry, but even more
importantly the consumers as well.
Senator Durbin. Dr. Zawel.
Ms. Zawel. Thank you, Senator, for your question.
I think that the--as you described it--litany of the facts
and the numbers behind how our system is designed seems rather
silly, and I do not think that anybody would sit down and say,
``Is this a great idea? Should we do it if we were going to
start to build it that way?'' However, we have come this way
through history and through adapting to the needs that are
there, and so we, in fact, have a system that is exactly as you
described, and I think that it deserves to change with the
changing needs of the consumers, with the changing needs of
food safety, and it has to adapt just like anybody else in this
world does with change.
To do so does not necessarily mean wiping out, exactly as
you described, the system that exists, but perhaps it means
altering the system and how it works through maximizing
coordination.
Senator Durbin. Thank you. Dr. Nagle.
Ms. Nagle. Thank you for the question, and I think I have
got to agree with most of what has been said by my colleagues
here. We at United acknowledge that it sounds silly. When you
read this litany, it does kind of make you chuckle and say,
``If you were doing it, you would not build it that way,'' but
it is already built, and it has actually worked remarkable
well, especially considering how disjointed it seems.
We do think, though, that better coordination and more
efficient allocation of the resources needs to be accomplished
in some way, and we think that really focusing on research and
coordinated efforts for education is really a key part of any
revamping of the program that needs to happen.
Senator Durbin. Let me shift the topic from science and
food to politics. I know it is kind of far afield from this
hearing, but let us try it for a minute.
Senator Collins and I agree on many things. I am not sure
we necessary agree on what I am about to say. I will concede
completely her point that we need, as you have testified, to
revamp our system, to change the laws dramatically, to make
certain that it is more effective.
We have had ample testimony to suggest that virtually every
Federal agency with any responsibility when it comes to food
safety inspection needs to be reviewed and updated. Some of the
things that we have been told are just horrifying to think that
this kind of bureaucracy, and inefficiency, and incompetency is
being tolerated at the expense or danger of the safety of
American families and the food that they consume.
Having said that, I also believe that, since we are now
embarking on a new era where the American consumers' demand for
imported food has grown dramatically, and where the American
consumers' demand for safe food is one of the highest
priorities, if not the highest priority, imposed on the Federal
Government, that it is naive for us to believe that just
changing the law is going to accomplish this.
Now, having said that, I think there is a need for more
resources here, and more resources to provide more personnel.
When you find that there are fewer FDA inspectors than there
are ports of entry, then you get an idea of the size of the
challenge here.
Now we have engaged here for a while in this testimony, and
I have been party to similar testimony at least in the past 12
or 13 years. There is a little ping-pong game going above the
table. Let me tell you about the bowling balls that are being
thrown under the table. Most of the organizations represented
here--I will just go right out on the limb and say it--hate the
idea of a user fee like the devil hates holy water.
The thought that your association members would have to pay
a user fee for inspection is something you do not want to
suggest they would embrace, in fact, they despise the idea.
They do not want to pay for it. And so what are our
alternatives? If we need more resources--I believe we do. Some
may argue we do not--if we need more resources, and if we are
not going to impose a user fee on the people who are going to
have their product inspected, then the alternative is to turn
to the Treasury and say, ``Appropriate more money.''
Well, we know better because we are in an era of balanced
budgets, and there is just not that much money to go around.
And year-in and year-out, for as long as I can remember,
administrations--Republican and Democrat--have talked about
user fees as the way out and nothing has happened. It is a
nonstarter.
A long introduction to what I am about to say. The reason
why I think we need to move to one agency, avoiding this
duplication, coordinating these services, is that we can
generate more service out of the people that we have, and each
of you are kind of edging into that.
Mr. Hammonds, in your testimony when you talked about
moving USDA personnel into areas that might be more directly
involved in food safety inspection, when each of you talks
about coordinating FDA and USDA, you are heading in my
direction. We are really reaching the point I think we all know
we have to reach. We need one agency that is not overlapping,
that is not duplicating, that has a set of scientifically sound
principles that your members can live by.
I think, honestly, I would like to commend to each of your
organizations to think about this again, and if from just the
most selfish interests say this may be the only way to avoid a
user fee is to put one agency in place and take all of the
personnel involved and put them out doing their job in a more
scientific and sensible way, so that your members know what the
rules are and the consumers are getting a job well done. That
is my speech.
Now, having said that--if anybody would like to comment
they are welcome to. I know this is questions and answers--let
me ask you about the problem of equivalency, and let me go back
to what Senator Collins said. She is right. We are not talking
about identical standards.
Let us get down to basics here. If we are talking about the
contamination of water, if we are talking about terrible things
which occur when you do not have sanitary standards around
those who are handling food and picking crops in other
countries, we might respond to it in the United States by
saying we need portable toilets, we need someplace where an
employee can wash their hands. What are they going to do in
Honduras? What is the answer there? What is the equivalency
there? And that I think is the real question we ought to
consider.
I think we need to move towards some sort of equivalency.
In fact, we are almost bound to by our trade agreements, if we
want to have it enforceable. But I want to make sure we follow
through on this. Are we on the same wavelength here; that we
might be talking about different approaches with the same goals
in mind, in terms of sanitation, which appears to be one of the
most basic concerns here.
Dr. Zawel.
Ms. Zawel. Well, I think that equivalency is the
appropriate term to use. I think what you said is that our goal
in achieving equivalency is exactly the same. The approach is
what I would call the devil is in the details, and that is
where our concern would be.
I would describe, in my mind, without having thought in-
depth about how we achieve the equivalency, I think that is a
very complex question that deserves a tremendous amount of
thought, but I think that what we want to see is not how many
toilets are in Honduras and how many are in the United States
but, in fact, do we have an equivalent food safety
infrastructure in Honduras and in the United States. But I do
not want to go so far as to conflict with Dr. Nagle, who
appropriately stated that we cannot blacklist an entire country
just because there is a perception that everything coming from
that country is, in fact, being produced in an unsafe manner. I
do not think that that is the case at all, but there are silos
within countries that can achieve equivalence and that we
should look at it that way.
It is not necessarily a direct answer to how we do it, but
I think that equivalency is certainly the goal that we are all
interested in.
Senator Durbin. Mr. Hammonds.
Mr. Hammonds. If I might comment on both of your issues.
First, as to resources, we provided what we feel is a revenue
neutral way to bring substantial resources to bear on our ports
of entry. You prefaced your remarks by saying it was a
political issue. Fortunately, the single-agency issue is one
you ultimately have to make a judgment on and we do not. But we
feel that there certainly is a chance that this could be done
with a cross-utilization agreement. And while we are debating
the single-agency issue, perhaps, that is a reasonable way to
get started and get started quickly.
So we think that is a way to be able to dramatically
improve our monitoring at ports and not have to go to user fees
or tax dollars.
On the issue of equivalency, let me just draw on the
Guatemala example very quickly, if I might. I think the
important thing here is it is not a one-way determination. This
can easily, and should, be a dialogue.
In the situation with the Guatemalan raspberries, the
country of Guatemala came to Food Marketing Institute I think
because we were not directly involved in buying products, but
represented the end consumers and their expectation that the
product was going to be safe. And we worked very closely with
the country, with the growers in their home country, and with
the Food and Drug Administration and, together, worked out a
very reasonable solution.
So I think if this is undertaken as a dialogue between the
importing countries, and the countries' own producers, and our
Federal agencies, that a very reasonable solution can be worked
out, and often without having to involve the lawyers as the
final arbiters here.
Senator Durbin. Thank you. Thank you, Madam Chair.
Senator Collins. Thank you, Senator Durbin.
Dr. Zawel, I want to follow up on Mr. Hammonds' idea for a
redistribution of resources from FSIS to FDA port-of-entry
inspections. Could you comment on whether you agree with his
proposal in that area.
Ms. Zawel. Well, our comment, also in the context of
responding to Senator Durbin's statement, which is that a
single food safety agency is perhaps--that was his
recommendation. I think, historically--as we have historically
built this regulatory system that we have, we have historically
set up silos that exist, and to break down those silos is what
I mean by coordination and maximizing coordination, and
efficiency, and effectiveness, and one of the mechanisms to do
that would be to redistribute the resources that we have within
each of these silos, if you will, to the changing needs of food
safety.
And so, perhaps, that is one recommendation that certainly
would make some sense.
Senator Collins. Mr. Bernard, I want to go back to the
point that you made about the accreditation of labs and that
you felt this would be a needlessly expensive undertaking. It
was GAO that first raised concern about the lack of control
that the FDA had on the samples that were taken from suspect
shipments and the lack of control over labs. Again, FDA's
process contrasts with FSIS, which does use accredited labs.
If FSIS is able to use accredited labs, why are you
concerned that it would impose a new excessive cost on the
system for FDA to adopt the same approach?
Mr. Bernard. Thank you, Senator, for the question. FSIS
typically uses its own laboratories for testing samples and,
obviously, they have a great deal of confidence in those
results because of the controls in place. FDA has obviously its
own microbiological capabilities. But to expect their
laboratory to keep up with such a volume of samples that might
be derived from intensive sampling of imports seems impractical
to us.
The alternative would be to use accredited private
laboratories. Our concern is that, while that is a strategy
that is certainly worth looking at. There are private
organizations looking at (and almost finalized) in putting
together a program to accredit private laboratories, that could
be capitalized on. But whether that would match with what the
Federal expectations are, what consumer expectations are is a
question mark.
An accreditation program, I think, with government
intervention would involve check samples, would involve
scripting out exactly what laboratories are supposed to do, and
would involve on-site inspections, further stretching
inspectional resources.
It should be a topic of discussion as to whether it is
worth that kind of expenditure or whether there is not
something else that we could do to achieve the same end without
having to go through that many hoops and spend further Federal
resources.
Our proposal is that, as we have done for years in the
canned food industry, after some time of working with an
organization, the government knows who they can trust and who
they cannot trust. In this case, the government should pull its
own samples for verification, and if they disagree with
laboratory results submitted by a laboratory and that pattern
is established, then you can assemble a list of those who are
just not producing the right kind of results.
So I think that our proposal merely is a consideration
whether there is a less expensive, less resource-intensive way
that we can achieve the same assurance. If not, then obviously
we are just trying to look at all options. We are proposing
that as a different option.
Senator Collins. I appreciate your clarification on that
issue. Would you agree that the current system does allow for
avoidance of the FDA's process by an unscrupulous importer?
Mr. Bernard. Based on the GAO's report, sure. We can see
that there is room for improvement in the system, not only in
the way the samples are collected, but in the way the
laboratory analyses are run. I think probably the main concern,
based on some of the conversations we have had, is just
security of the samples, making sure the right product gets
sampled and that there is no opportunity or little opportunity
for firms to substitute good products for bad when the samples
are to be taken.
Senator Collins. Thank you.
Mr. Hammonds, I want to switch gears and ask you about an
initiative that I understand FMI has undertaken called your
Total Food Safety Management project. It is my understanding
that you are working with a firm in Westbrook, Maine, called
IDEXX, which has been in the forefront of developing some food
safety tests. Could you tell us a little bit about your project
and whether you think it might be a useful model.
Mr. Hammonds. Yes, I can. The project is really based on
the general principles we have been talking about here, and
that is focusing on prevention, focusing on risk analysis so
the resources can be put in the right place at the right time.
What we are doing is developing for our supermarket members
models to maintain the safety of critical food products in the
store. So our first initiative here was to look at the kind of
products we handle and make a determination of where we thought
the resources would be best allocated to protect the products
and identify a half-dozen of those. They would include cut
produce, cooked chicken, and ground beef as three of the
specific products we look at.
Then we recruited volunteer supermarket companies to work
directly with the group in Maine. We put their scientific
experts in the stores to make a determination of the critical
control points; that is, what points in the system of
delivering this product from the consumer, all of the way from
receiving from our suppliers and working with our suppliers on
the kind of standards for products that we buy from them might
entail, and then they are in the process now of identifying
those critical points where training, and recordkeeping, and
monitoring would be most effective.
As they identify those, they will develop specific training
modules for in-store personnel that people can understand and
implement without having to be a food safety technical expert.
We then will test that system in a real-world setting and
monitor the end product. And once we determine the control
programs, the training programs, and in-store monitoring are
effective, we will make that available to the entire industry.
So that as we train our in-store personnel in each of these
departments, we can direct them to the critical control points
where they will be most effective and give us the highest
quality and safest products for consumers.
So it is a very specific product-by-product hazard
identification and training program designed for supermarket
employees.
Senator Collins. Thank you. I think that does have a lot of
promise, and it is part of my belief that each of us has a role
to play in improving our food safety system, and I appreciate
knowing of your efforts.
I just have one other question that I want to ask all of
you, just to make sure we are clear on the record. I believe I
have heard this morning three out of four of you oppose any
additional authority for the FDA in this area, but I just want
to make sure that I understand whether you are talking about
just the equivalency or across-the-board.
I also want to make sure, starting with Dr. Nagle, in view
of your comment on port shopping, that we share the evidence
that we have that there is extensive port shopping going on by
unscrupulous importers, but I will have the staff share that
evidence with you.
But I will start with you, Dr. Nagle. Specifically, do you
support any additional authority for the FDA to ensure the
safety of food imports?
Ms. Nagle. At this point and, again, I am not a lawyer, but
United's position is pretty clear. We believe that they have
sufficient authority under the current Act to deal with denying
entry for an imported product. And if we use the Guatemalan
example, it also shows that they have the capability to go to a
foreign location and to work with them there and inspect the
fields. So, that it does not seem that there is anything in the
statute that prevents them from doing that now, and, therefore,
they do not need any additional authority granted to them.
Senator Collins. Dr. Zawel.
Ms. Zawel. I would certainly agree. As I said in my
statement, we believe that FDA does not need any new authority
to assure that foods coming into this country are safe. In
fact, what they do need is a reassessment of their current
activities, a reassessment of resources and more coordination
to increase their effectiveness.
Senator Collins. Mr. Hammonds.
Mr. Hammonds. Well, we believe you need an effective
control system and you need the proper resources to carry it
out. If the FDA were to identify additional authority that was
needed and the scientific community could agree that that
would, indeed, be beneficial then we would not oppose that.
Senator Collins. Mr. Bernard.
Mr. Bernard. Thank you.
I think Mr. Hammonds said exactly our position. We remain
today convinced that there are changes that need to be made.
The Senator mentioned earlier that there are documented
outbreaks that cannot be denied. There are improvements
necessary. We do not feel today, however, that all of the
existing options have been fully explored, so, we remain, at
this point, unconvinced that there is a need for additional
legislated authority.
Thank you.
Senator Collins. I thank you very much for your testimony
this morning. The debate on that issue will, obviously,
continue with our next panel. It's fascinating to me to hear
your testimony when FDA and GAO believe FDA needs additional
authority, but it is an issue I raised with FDA officials
yesterday that they were able to take effective action in the
case of the Guatemalan raspberries.
But we will see, as the debate continues, where this comes
out.
Thank you very much for your testimony.
The next panel of witnesses will provide the Subcommittee
with recommendations from consumer groups and public health
officials. Dr. Richard Levinson is the Associate Executive
Director for Programs and Policy of the American Public Health
Association. This organization is comprised of over 30,000
individual members and 20,000 additional State and local
affiliate members and represents more than 75 disciplines in
public health and related fields.
Carol Tucker Foreman is representing the Safe Food
Coalition, an umbrella group of consumer, public health, senior
citizen and labor organizations that works to educate the
public about the hazards of foodborne illnesses.
I would also note that Ms. Foreman is a former staff member
of this Subcommittee, I learned last night, in one of her first
jobs after graduate school. So, it is a great pleasure to
welcome her back to PSI today.
Dr. Ruth Kava is the Director of Nutrition at the American
Council of Science and Health, a consumer education consortium
concerned with issues related to food, nutrition, chemicals,
pharmaceuticals, the environment and health. This organization
is led by a Board of 250 physicians, scientists and policy
advisors.
Robert Hahn is here on behalf of Public Voice for Food and
Health Policy. This is a national nonprofit research and
advocacy organization that looks at food and agricultural
policy from a consumer perspective and promotes a safer,
healthier and more affordable food supply.
Pursuant to Rule 6, I am going to ask you to stand and be
sworn in. Would you raise your right hand?
Do you swear that the testimony you are about to give, is
the truth, the whole truth, and nothing but the truth, so help
you, God?
Mr. Hahn. I do.
Ms. Foreman. I do.
Dr. Levinson. I do.
Ms. Kava. I do.
Senator Collins. Thank you.
As for the previous panel, I am going to ask that you limit
your oral testimony to 5 minutes. If you need an additional
couple of minutes to finish up, however, feel free to take that
time and the green light, yellow light and red light will help
guide you.
I am going to start with you, Dr. Levinson.
TESTIMONY OF RICHARD LEVINSON, M.D.,\1\ ASSOCIATE EXECUTIVE
DIRECTOR FOR PROGRAMS AND POLICY, AMERICAN PUBLIC HEALTH
ASSOCIATION
Dr. Levinson. Thank you, Madam Chairman.
---------------------------------------------------------------------------
\1\ The prepared statement of Mohammad N. Akhter, M.D., MPH, was
submitted on behalf of the American Public Health Association, appears
in the Appendix on page 221.
---------------------------------------------------------------------------
My name is Richard Levinson and I am the Associate
Executive Director of the American Public Health Association
and I am very grateful to present our point of view on how we
can help ensure the safety of the food supply for the American
public.
I wish to begin by emphasizing that we strongly believe
that food safety is a major public health problem in the United
States. We concur that the food supply in this country may be,
indeed, the safest in the world but despite lack of solid
information about the incidence of foodborne illnesses, our
estimates or the estimates that are provided indicate that
millions of such cases of foodborne illness occur each year in
the United States, and that some of them, perhaps a small
number, but some of them do lead to death and disability.
The whole process of foodborne illness is certainly a major
cost to the United States in terms of medical care and
disability resulting from such illnesses. We cannot say that at
this time that imported food is necessarily less safe than
domestic food, but we certainly know very clearly that imported
food has been responsible for a number of recent outbreaks. The
Cyclospora, the Hepatitis A and Salmonella instances indicate
this very clearly.
In view of the fact that the volume and percent of imported
food is steadily rising in the United States, our risk-based
approach suggests that we should be very much concerned about
imported food and its safety.
Looking at the ways in which we might improve the safety of
imported food, I have to begin by stating that we will never be
entirely successful in that effort until our own system of
guaranteeing domestic food safety has been improved upon and
made basically more optimal.
The National Academy of Sciences in its recent publication,
which is entitled, ``Ensuring Safe Food From Production to
Consumption'', has pointed out that there are some 12 agencies
in the United States that are responsible for food safety and
that they operate under 35 different legislative statutes, some
of which are contradictory in their scope.
The result has been that there is a great deal of
fragmentation, duplication, overlap and even outright conflict
in the enforcement of food safety activities within the United
States from the Federal Government point of view. Furthermore,
the Federal approach rarely gets down to the State and local
individuals who are also trying to monitor food safety and it
has rarely involved the public to the extent that it should
since the public is the key factor in this whole equation.
Looking at the Federal organizational approach to food
safety it is quite clear that the Department of Agriculture and
FDA are the two principle agencies but the other 10 cannot be
disregarded. These two agencies also overlap and conflict in
many of their activities domestically, and the famous example
of the pepperoni pizza in which we have two agencies inspecting
one product, often at the same time, and certainly creating a
certain amount of confusion not only for the makers of
pepperoni pizza.
If we look at their activities internationally, it is
perfectly clear and apparent that they are approaching control
of food safety under an international basis in a totally
contradictory manner. The equivalent authority that FSIS, from
the Department of Agriculture, has is perhaps not entirely
perfect but it seems to be infinitely preferable to the point-
of-entry approach of the Food and Drug Administration.
The FDA simply does not have the person power or the
ability to monitor every point-of-entry by which food might
enter the United States and current estimates are that it
monitors less than 2 percent of these points-of-entry, which is
grossly inadequate.
You have dwelt in your previous testimony on the
inadequacies of assuring control of food that is being
embargoed for inspection by the FDA by the use of questionable
laboratory procedures and laboratories to monitor it, and by a
whole host of other issues that arise in this point-of-entry
type of situation.
What do we recommend be done about improving the situation?
Now, there are many, many aspects of this. Certainly the
science has to improve, certainly the methods of inspection and
surveillance need to be extended, but we think that the whole
thing could be significantly improved, including all of its
aspects, by developing a single Federal agency which has the
total authority and responsibility for all Federal activities
in food safety, both domestic and international. This agency
should cover all of the functions that are related to food
safety. It should have the resources necessary to carry it out.
And, most important of all, it must have the legislative
authority to be effective.
Until this happens we are convinced that patchwork types of
solutions, which have been employed in the past in attempting
to make agencies more equivalent in their approach to
international or domestic food safety issues, simply will not
work. I notice that my time is up and I can further expand in
the question period on this. But, I think that I do want to
emphasize we feel this is the most important thing we can
contribute to the debate, the support for a central agency.
Senator Collins. Thank you very much, Dr. Levinson.
Ms. Foreman, would you, please, proceed?
TESTIMONY OF CAROL TUCKER FOREMAN,\1\ COORDINATOR, SAFE FOOD
COALITION; ACCOMPANIED BY CAROLINE SMITH DeWAAL, DIRECTOR OF
FOOD SAFETY FOR THE CENTER FOR SCIENCE IN THE PUBLIC INTEREST
ON BEHALF OF THE FOOD SAFETY COALITION
Ms. Foreman. Thank you. Good morning. I am here as the
Coordinator of the Safe Food Coalition, a group of consumer,
public health, senior citizen and labor organizations who have
worked together since 1986 to improve the Nation's food safety
system. The coalition was instrumental in persuading the
Federal Government to revise the 100-year old meat and poultry
inspection system. My own interest in this issue stems from my
service as Assistant Secretary of Agriculture for Food and
Consumer Services during which time my responsibilities
included meat and poultry inspection.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Foreman appears in the Appendix
on page 229.
---------------------------------------------------------------------------
My testimony today was prepared by and is based on research
done by Caroline Smith DeWaal of the Center for Sicence in the
Public Interest. My oral statement is taken from that.
Our coalition appreciates very much both the vigorous and
meticulous work that this Subcommittee has done in
investigating and documenting the problems with the safety of
imported foods. You have revealed a number of weaknesses that
are serious and have to be resolved.
Neither our domestic nor our imported food supplies are
safe enough. It is true that millions eat safely every day but
it is also true that millions get sick every year and that
thousands die from foodborne illness. That toll can be and
should be reduced.
We are more aware of problems with imported foods now
because imports have expanded so dramatically. Thirty-eight
percent of our fruit now comes from other countries, as do 12
percent of our vegetables and half of the seafood we consume.
That is not a bad thing. We live in a world market. I love
as an individual, and its clear consumers all over the country
love, having access to food that comes in from other places. It
is nice to be able to have that summer fruit in the middle of
the winter here. But it is acceptable, in fact, it is
reasonable that we will demand some assurance of safety in
those foods.
While food imports are expanding, the Food and Drug
Administration's resources allocated to inspecting them are
declining. In 1990, they physically inspected 8 percent of the
imported food; today they will physically inspect only 1.6
percent. Inadequate inspection has consequences.
CSPI has identified 14 outbreaks of foodborne illness since
1980 associated with imported food--cantaloupe, crab meat,
tuna, cheese and strawberries are among them. Countries of
origin include Ecuador, Portugal, Israel, the Netherlands, and
Guatemala.
I would like to make some suggestions about how to improve
the safety of imported food. The Congress can start right now
this week--by starting to provide FDA with some additional
resources to do the job that needs to be done. It can improve
the Agriculture Appropriations Act Conference Report by
approving an increase of $68 million in the President's Food
Safety Initiative. That would give FDA an additional $26.7
million for new import inspections.
The agency needs those resources and they need them, I
think, immediately. I think your hearings and investigations
indicate that over and above all other things.
We need to give FDA the authority to do the job. And you
have several pieces of legislation pending before the Congress
now. S. 1707 and H.R. 2052 provides specific authority to
reject food from countries that have denied FDA inspectors
access to review growing and processing.
H.R. 4080 would provide a modest fee to importers in order
to increase border inspections and begin to develop real time
microbiological testing.
H.R. 3676, the Consumer Food Safety Act, would require both
domestic and foreign food processors to register with FDA and
requires regular inspections of all high-risk processors. We
believe that is absolutely essential for FDA to have some
equivalency authority similar to that of USDA.
I have had experience with administering USDA's system. It
works reasonably well and I would be glad to answer questions
with regard to that if you would like me to later.
The second thing you can do is to rationalize and unify the
entire food safety system as recommended by the National
Academy of Sciences. It is really essential to revamp the
statutes, to have one unified food safety law and avoid
different authorities, requiring different things.
The basic goal of those should be to protect public health
and to allocate resources according to the risk to public
health. We need one Federal official with the responsibility
and the authority to do the job.
Again, I can tell you from a personal perspective that the
present system just does not work. And if you ask anybody who
has ever had responsibility for administering either meat and
poultry inspection of the Food and Drug Administration, they
will tell you it is a miserable way to achieve an effective,
efficient food safety system. At least two Members of your
Subcommittee support the creation of a single food safety
agency.
My time has expired. I do want to say one last thing. I
have some serious concerns about GAO's proposal for redeploying
resources, $271 million, from FSIS to FDA and if the
opportunity arises I would like to comment on that.
Senator Collins. If you would like to comment right now on
it, feel free to do so.
Ms. Foreman. OK. Thank you.
I am not a defender of the old-fashioned way of inspecting
meat and poultry. I have spent a lot of time trying to change
it. The Department of Agriculture has now taken that on and is
trying to do away with this 100-year old system and introduce a
modern system.
We have to be careful that we take reasonable and rational
steps to get from here to there. It is a 100-year old system.
There are 6,000 plants out there. Some of them are very
sophisticated and some of them would shock you at their lack of
sophistication. They rely on the inspector to walk in every
morning and tell them to wash the equipment. If the inspector
fails to say that, they do not wash the equipment.
Public health is at stake. We have to move carefully and
judiciously from that old system to the new system. There are
7,200 inspectors and 6,000 plants. I am afraid if we say, all
right we got a new system. Let's pull everybody out of these
plants and send them over to the Food and Drug Administration,
we may have terrible negative unintended consequences.
I am perfectly prepared to see a plan that lays out a time
certain for beginning to move away from the old inspection
process. I am prepared to redeploy resources as data come in
that show the new system works in reality as well as in theory.
USDA has those studies underway now. I am confident that they
are going to show that the system is working. But I am afraid
that because of what the GAO recommended, inspectors will be
pulled out of plants and public health will suffer.
Senator Collins. Thank you.
Ms. Foreman. Thank you.
Senator Collins. Dr. Kava.
TESTIMONY OF RUTH KAVA,\1\ PH.D., R.D., DIRECTOR OF NUTRITION,
AMERICAN COUNCIL ON SCIENCE AND HEALTH
Ms. Kava. Thank you, Madam Chairman.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Kava appears in the Appendix on
page 241.
---------------------------------------------------------------------------
The American Council on Science and Health thanks the
Subcommittee for the invitation to testify here today. And we
would like to basically reiterate some of our written
testimony. First of all, between 1983 and 1997, according to
the GAO report, there were at least 17 outbreaks of foodborne
illness in which imported foods were suspected, if not proven,
sources of pathogens.
But it is not clear, according to some work done by USDA,
that imported foods pose any greater risk to the health of the
American people than do domestic counterparts, simply because
the information is not really there. It is fragmentary. Not all
outbreaks of foodborne illness are traceable. We do not know
exactly where--although the Mexican strawberries, obviously,
came from Mexico, they were contaminated with Hepatitis A but
they were processed in the United States. So, my understanding
is we really do not know where that contamination occurred.
This kind of issue is also a problem in determining exactly
where the onus of responsibility lies for certain types of
foodborne illness outbreaks.
As has been noted here by several people this morning, the
importation of foods and food products has increased
substantially. In 1996, imported foods accounted for 21 percent
of domestic fresh fruit and vegetable consumption. And this is
probably going to increase. As has also been noted, we like
having our fruit and vegetables in the middle of the winter
that we cannot grow here ourselves.
Now, the GAO report certainly indicates that there are
major discrepancies between the responsibilities of the FDA
with respect to maintaining imported food safety and the
resources which that agency is given in order to perform that
function. The FDA faces an increasing volume of imports but has
a static number of inspectors, insufficient financial resources
and we feel a lack of legal authority compared to that granted
to USDA.
We, therefore, would recommend that these discrepancies be
eliminated and that Congress take steps to enable FDA to
perform its regulatory functions more efficiently. With respect
to the question of equivalency, we see it as a positive thing
that FDA be granted some sort of authority to ensure
equivalency in the scientific sense. I know we have discussed
the definition of the word here this morning. And that perhaps
the timing with which this equivalency requirement be enforced
be flexible to allow us to take into account the differential
abilities of trading partners to come up to speed.
FDA has already established memoranda of understanding with
some countries and that process could continue and evolve into
some sort of an equivalency situation.
We also feel that all existing food safety oversight
agencies should support and expedite the use of existing
technologies such as food irradiation that we already have
approval for but which are not yet being used. Partly, we
understand because there are bureaucratic problems with getting
guidelines set up so that people can actually go ahead and use
these technologies.
In terms of the efficiency of use of the different
agencies, we see this as one way in which efficiency could be
improved. We do have existing technologies that could help
improve food safety and we are not using them. We should be
using them. We would like to encourage that.
We would also like to encourage focusing on proven health
risks in Congress' efforts, not those that are based on
hyperbole. I noted in the GAO report, some of the testimony
there emphasized that FDA has said for many years that the
greatest risk in terms of foodborne illness are microbial
pathogens. And, yet, what you hear out there from consumers and
what we get questions about, not infrequently, are things like
pesticide residues. To my knowledge, pesticide residues have
not been the proven cause of any major outbreak of foodborne
illness. It is a constant fear but there does not seem to be
good data supporting that.
Finally, we also feel strongly that there needs to be more
education effort to tell the consumer about what the real risks
of foodborne illness are, more education in terms of how they
need to handle and prepare foods in order to avoid foodborne
illness, and perhaps just as importantly, to educate the public
to an understanding that there is no zero risk. That there is
always some level of risk and the government is not going to
save them from all possible foodborne risk possibilities. Thank
you.
Senator Collins. Thank you, Dr. Kava.
Mr. Hahn.
TESTIMONY OF ROBERT HAHN,\1\ DIRECTOR, LEGAL AFFAIRS AND
RESEARCH, PUBLIC VOICE FOR FOOD AND HEALTH POLICY
Mr. Hahn. Thank you.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Hahn appears in the Appendix on
page 244.
---------------------------------------------------------------------------
Madam Chairwoman and Members of the Subcommittee, good
morning. My name is Robert Hahn, Director of Legal Affairs and
Research at Public Voice for Food and Health Policy, a
nonprofit consumer research and advocacy organization that
seeks to ensure a safe, nutritious and affordable food supply.
To avoid being unduly repetitive, let me just say that we
agree that the FDA system for ensuring the safety of imports is
clearly in need of reform and that many of the needed reforms
will require legislation and additional resources.
The first order of business should be for FDA and its
partner, the Customs Service, to improve border inspection and
to eliminate the many opportunities for unscrupulous importers
to commit fraud. Some of these measures FDA and Customs can
take now without Congressional action and, as we heard
yesterday, the two agencies are moving to do so.
For example, Customs should increase the civil penalties
for food safety violations. FDA inspectors and not the importer
should collect all samples for lab testing, and all testing
should be done by either an FDA lab or an accredited private
lab. And FDA and Customs must find a way to ensure that
rejected shipments are reexported or destroyed.
Other needed measures will require legislation. We believe
that Congress should authorize FDA to require the registration
of all food importers and to charge them a nominal registration
fee. Second, FDA should have the authority to require the use
of accredited laboratories.
Third, Customs should have the authority to require
importers with a history of violations to use independent
bonded truckers and warehouses at their own expense. Fourth,
Congress should give FDA the authority to stamp rejected
shipments with the words, ``Refused Entry.'' And, fifth,
Congress should give FDA the authority to levy civil fines. FDA
should not have to rely on Customs, an agency with different
priorities, to collect fines for food safety violations.
While improving border inspection is important, border
inspection has serious limitations as a way of ensuring the
safety of imports, as we have already heard.
Given the increasing volume of imports and the resource
constraints on the FDA, FDA will probably continue to inspect
only a very small percentage of imports. And even when a
shipment is inspected and a sample taken for lab testing, it is
very difficult to catch contamination which may be randomly
distributed in the product, and certain types of pathogens,
such as viruses and parasites, are very difficult to detect at
all.
Giving FDA equivalency authority is the long-term solution
to the problem of unsafe imports. If we are going to import
food from around the world, we ought to know something about
the system under which it was produced. With equivalency
authority, FDA could require exporting countries to open their
food safety systems to FDA review and if FDA knows that an
exporting country's food safety system is a disaster waiting to
happen, FDA should have the authority to ban its imports
without waiting for a major outbreak of foodborne disease.
Finally and equally important, FDA needs additional funding
to perform its responsibilities effectively. It is clear that
FDA will need significant additional funding if it is to ensure
the equivalency of foreign food safety systems while
maintaining an appropriate level of inspection at the border.
Thank you for this opportunity to share our views, and I
would be happy to answer any questions.
Senator Collins. Thank you very much, Mr. Hahn. And thank
you all for your helpful testimony.
After listening to five different days of testimony and
doing a lot of work in this area, it seems to me that there is
a consensus that we need to fix some of the smaller
administrative problems. For example, FDA ought to be marking
or stamping shipments, ``Refused Entry,'' so that they cannot
so easily be entered into the American market place.
And we need better fines so that it is not just a cost of
doing business if you get caught violating the law. We need,
perhaps, to give more authority to agencies to impose civil
penalties, so that there is a greater range of penalties.
Then we come to the harder issues. And it seems to me they
break down into three categories. There are those who believe
that the only way to improve our food safety system is through
a dramatic organizational change. Senator Durbin has worked
very hard over the years in favor of advocating a single food
agency and Dr. Levinson endorsed that today, as have others.
There are others who believe this is really a resource
issue. And that the problem is that FDA only inspects fewer
than 2 percent of all shipments. And that you really need to
have more resources so that FDA can do more inspections and
that it is a mismatch of inspections versus the volume of
imported goods.
The third category of people argues that we really need a
whole new system, that we are never going to be able to catch
up to the problem through ports of entry inspections and that
we need to go to an equivalency system and get at the root of
the food safety issues.
I am beginning to think that we probably need to do some of
all three. I am not convinced yet, although I may be
ultimately, that we need an entire new organizational structure
and I wonder what that does if you do not solve some of the
underlying problems with equivalency. But, clearly, we have
established a record that suggests that there are very severe
coordination problems because we have so many agencies
involved.
I would like to start with Dr. Kava and then go down the
row here, and ask your judgment. Is this primarily an
organizational problem, is it primarily a resource problem or
do we need a new system or is it a combination of all three?
Ms. Kava. It is probably, we would think, a combination of
all three. Although in terms of sort of junking the whole
system and starting over again, I am not sure that I see how
that would speed up the improvement of food safety because the
simple reorganization process, itself, would be lengthy and
complex.
It would seem that resources are a significant issue,
especially as outlined in the GAO report, and we would support
the Food and Drug Administration being given appropriate
resources in order to carry out its mandate.
Again, as far as equivalency goes, FDA, itself, has
apparently questioned the need or it sounded almost in the
report was concerned about having mandatory equivalence. We
would think that would be necessary eventually. That FDA and
FSIS should not have disparate levels of authority for ensuring
the safety of foods.
So that we would be in favor of it but we think also that
this could be worked out to be as painless as possible for
trading partners by working perhaps through the Codex
Alimentarius that the United States should take a leading role
in trying to effect those changes in that way too.
I think there are mechanisms by which equivalency could be
established and at this point, it sounds good to say, well, we
have 12 agencies and 35 laws, so, let us junk that and have one
system. But that does not--it sounds good but it is not clear
to us, at least yet, how that would definitely improve things
because with one agency you could also have a stranglehold over
a lot of different systems that might not benefit all of us
equally well.
Senator Collins. Thank you.
Dr. Levinson.
Dr. Levinson. Yes, thank you.
Certainly there are resource issues and whether you have a
new system, one agency or multiple agencies, the resource
issues will continue. More resources have to be put into the
whole process of guaranteeing food safety.
I think the equivalence issue for the international scene
has really been settled. I do not know of anybody that supports
the point-of-entry approach that FDA now uses over the
equivalence issue.
I think the problem comes up in defining equivalence, and
we have heard several definitions today. The one I prefer which
I did not hear is that it is exactly the same as the United
States' system. I know that cannot be achieved easily but it is
the goal towards which we have to work.
As far as revamping the system, I think that this is
necessary because of conflict in the legislation and in the
cultures of the organizations that implement that legislation.
But I think that any reorganization or any attempt to set up a
new agency would base it on science and on risk analysis and on
effective surveillance. So, however this is done, those three
principles have to be guaranteed.
And since these things are honored more in the breach than
in practice, enforcing them would set up a new agency or new
approach. I have already stated that I think there needs to be
one agency.
My principle reason is that unless you have that you are
going to continue to have conflict between organizations
involved in terms of their culture, their history, their
approach to the world, and although these various approaches
may be individually valid, you need one solid approach if you
are going to effectively regulate the food industry. So, I
think there has to be one agency.
Senator Collins. Ms. Foreman.
Ms. Foreman. I think that you scratched the itch of the
import problem and found that underneath it there is a much
bigger problem. I think that is what is happening here.
The problems that we have with the safety of imported food
is a reflection of a law and an agency structure that were
designed for another time when there were not international
markets of the kind that there are now and, certainly, when the
health risks were different.
Carcass by carcass inspection was set up when the same
things that made animals sick made human beings sick. That
stopped being true a long time ago, but we have updated the law
to deal with today's problems. Congress should begin to deal
with this problem.
I suggest a Presidential Commission be appointed. Put all
the people that you have heard over the last several days of
hearings who disagree on this issue in a room and give them a
time limit to work something out. It would happen.
Senator Collins. I like that idea.
Ms. Foreman. We keep doing this minuet. The industry people
say they oppose it. We say we support it. Put everybody in a
room and say, fix it. I think it would get fixed. And I think
what would come out would be a document that would be useful in
educating the American people and the Congress about why it is
worth going through the struggle to reorganize.
I am going to keep coming back to the resource issue. It
would be resolved in small part by reorganizing. There are
duplicate administrative and budget staffs at these agencies.
Those could be eliminated by bringing the agencies together.
You have a few places where you have FDA and FSIS and OSHA
inspectors a plant.
Most importantly, you could redeploy resources more easily,
because all would work for the same agency. It does not have to
be an independent agency. I could think of a lot of ways you
might do it.
Let me address equivalency for just a minute. It is a first
step. It is probably the easiest of the things that you might
do.
USDA's equivalency system works pretty well for what it is.
Organoleptic inspection is not a good system for today's
problems and equivalency does not work to the extent that it is
demanding equivalence on things that are not important any
more.
As USDA moves to a HACCP system and to performance
standards that limit pathogen levels in a product, you answer
much of the fear that the industry has about how to define
equivalency. If equivalency means you have to meet the same
performance standard that people in the United States meet in
terms of microbial contamination of the product, that is a
science-based standard for equivalency.
Thank you.
Senator Collins. Thank you.
Mr. Hahn, is it more an issue of organization, resources,
or do we need a whole new system?
Mr. Hahn. I agree that it is a combination of all three. I
think the immediate need is to add additional resources and to
take measures to fix the existing system. But I also support
the creation of a single food safety agency.
Senator Collins. Thank you.
Dr. Levinson, you represent the Public Health Association
and, thus, have knowledge of the interaction among the various
levels of government on food safety. In one of our hearings we
heard from the CDC which described the trace back process and
the necessity for a physician to identify a foodborne illness
which oftentimes does not occur, and then report it to the
appropriate officials.
How well do you think that system works, the coordination
among the private physician, the local public health agency,
the State and the CDC and Federal officials?
Dr. Levinson. Let me begin by stating that even in areas
where we have reporting by law, for example, a number of
infectious diseases that must be reported, we consider an
outstanding result has occurred when 50 percent of the cases
are reported.
So, even when required by law it is very, very difficult
because it is troublesome in the current system, pencil and
paper and so on, to get the reports in, to remember to meet
deadlines, etc.
Where you have a totally voluntary system like we have for
food safety, it basically does not work at all. There are
attempts to improve it with FoodNet and so on and, indeed, what
they involve is using other sources. You do not rely on the
physician's report, you look at the laboratories, you look at
other sources of information and then trace cases from that
source rather than waiting for only one group to report.
I think that improves the situation somewhat, but it does
not make it perfect. So, I think that this is a work in
progress and we still have a long way to go. I would be happy
if we had 50 percent of the cases of foodborne illness reported
but we are very far from that now. And I think the only way we
will get to a level even that high is if we do involve many
other components besides just the physicians reporting in order
to attempt to detect and trace cases of foodborne illness.
Senator Collins. At one of our hearings we had a witness
who was a scientist himself and who had been stricken as a
result of eating the infamous Guatemalan raspberries. And he
diagnosed himself as a result of reading a New York Times story
about the outbreak. He had been to his physician and his
physician thought he just had some sort of intestinal flu. And
he ended up diagnosing himself. But he had the advantage of
being a trained scientist and having seen the New York Times
story.
I guess my final question to all of you is how much more
education do we need to do to allow consumers to recognize
foodborne illnesses as well as improve their own food handling
since we know that that is a fairly common cause.
And how much more do we need to do to educate the medical
community to recognize foodborne illnesses?
Dr. Kava.
Ms. Kava. Well, I think we still have a lot to do to
educate consumers. I think polls and hidden cameras that try to
document how frequently people wash their hands, for example,
after using the restrooms, both consumers, ordinary people as
well as medical professionals, has revealed an astoundingly low
percentage of people who are compliant with this very basic
issue of safe, well, just general sanitation and safety. And I
think that that needs to be emphasized over and over again.
But some of it may also be out of control of consumers
because more and more of us are eating out much more frequently
in which case what we need to do is educate food service
workers to a greater extent or to the greatest extent possible
about sanitation.
I think this needs to be ongoing. Perhaps there could be
something done in schools so that children start learning about
these types of issues very early on and not just wait until
people are adults and they get sick.
The issue is also one of how can you alert people without
panicking them, without every stomach ache turning into E. coli
0157H7 or something like that? And I think that one needs to
teach people how to distinguish between a real foodborne
illness or something that could be serious.
FDA has now promulgated rules about unpasteurized juices
with warning signs up. I think that is very important and I
think that I would like to see some realistic information get
out there about the relative risks of things like organic foods
which are often fertilized with manure, which is a great
carrier for all sorts of bacteria and the necessity for people
to be very careful about washing organic foods.
I mean I know people who--and this is an anecdote--who say,
well, I don't have to peel my carrots, they are organic. And
this is someone who is very concerned about getting organic
produce because she does not want to eat pesticides.
So, I think that some of these relative risks need to be
put out there so that consumers can really see what is going
on. Because I think that we are having sort of an anti-science
movement in this country now and that people think that organic
is natural, organic is safer, and that they do not have to take
precautions.
Senator Collins. I think you have raised an excellent
point. Just recently the daughter of a friend of mine in Maine
got very ill because of E. coli as a result of drinking
unpasteurized milk. And I am stunned that she would let her
daughter drink unpasteurized milk but she thought by going to
this local farm she was getting the freshest, best possible
milk for her daughter. And her daughter fortunately is all
right but was hospitalized for a number of days and it was a
serious incident of foodborne illness.
But I, perhaps also as we teach people to eat more fruit
and vegetables, we need to teach them to wash the fruit and
vegetables before they eat it.
Ms. Kava. Yes.
Senator Collins. But, Dr. Levinson, do you have any comment
on the need for more consumer and professional education in
this area?
Dr. Levinson. Yes. Indeed, I certainly agree that more
consumer education is important. First of all, although we do
eat out more, people still handle a great deal of raw food in
their home and they do misuse that food in terms of food safety
because they do not know the rules or they ignore them.
I am very impressed that a lot of packaging of turkeys and
other products now show you or remind you what you should do
but I think many people ignore that, those admonitions.
But over and above all of that, over and above personal
safety and safety of the family, I think that it is important
to educate people about food safety so that as consumers and as
citizens they can make intelligent decisions about issues such
as what we have discussed today.
Unless the public understands the implications of and the
requirements of preserving the safety of the food supply, they
will not be able to assist their legislators and others in
dealing with issues like how do you handle the international
food situation, what do you do about inspection of processing
plants and so on?
When something dramatic happens, like the E. coli outbreaks
where people die, then the publications, the newspapers are
filled with information and people become very agitated and
activated and then a few weeks later they forget about it. I
think this is an ongoing issue. We are literally what we eat.
And we do need an informed public to lead us all to a higher
plateau of understanding and activity.
As far as the medical profession, there is no question that
they need further information about this and many other topics.
What they will do with this information will vary. Hopefully
they will report significant cases of foodborne illness because
for those cases there is a necessity to trace the source of the
contamination of the food and unless they report meticulously
about these cases, this tracing will never occur and we will
continue to live with estimates of 3 to 81 million cases of
foodborne illness a year. We will never be able to close the
difference and those statistics are not meaningful.
But also they need to be aware that many increasingly
foodborne illnesses are due to emerging infections and the
first evidence we have of the emergence of these infections
may, indeed, be foodborne illnesses. And the infections,
themselves, as with Cyclospora, may not involve a lot of
people, but they raise a number of troubling issues about how
well we are monitoring the food supply and how difficult it is
to detect something like Cyclospora in incoming food.
They also raise issues about strawberries versus
raspberries. You do not wash raspberries because they fall
apart. So, a restaurateur would use them, fresh from the box
without worrying about their sanitary condition.
So, I think that education of everybody is very essential
and has to be targeted, it has to be persistent and it has to
be very effectively presented.
Senator Collins. Ms. Foreman, in responding to this
question, could you also comment on what you see as the
government's role in encouraging more education in this area?
Ms. Foreman. Yes. Thank you.
I want to subscribe to what Dr. Levinson said about this
also being a process of educating the public about how public
policy affects their health. I believe everybody has to
practice self defense. In the end, we defend ourselves.
I am really very pleased that Public Voice for Food and
Health Policy and I are both involved with the Partnership for
Food Safety Education that is a combination of industry,
consumers and government. It put out the Fight BAC materials
and is working hard to get those distributed as widely as
possible.
We need education but we also have to have education that
competes in a market place of very slick messages. Food safety
messages have to compete with the swoosh and that is hard. It
is not the sort of thing that government educators or even
public health educators are used to doing.
We need messages that compete. The Fight BAC logo and the
icons around it provide a fast, quick indication of what you
need to do. It should refresh information that you have gotten
elsewhere.
I would like to see those messages to wash your hands, keep
your food separate, do not cross contaminate, keep food cold,
cook food well, become ubiquitous. I would like to see them
printed on every grocery bag that leaves a supermarket and on
carry-out food from all the chain restaurants.
We are just beginning to scratch the surface of what can be
done with this. There is agreement on those four messages. The
more people who come in with that message in slightly varied
form the better off it is for all of us.
Government has an important role to play in advancing that
information. And government has been working very hard at it. I
have not thought about what government might do beyond that.
There have been suggestions that the government urge people to
accept irradiation of food and to educate the population as the
government educated us at one time about the importance of
pasteurization.
I have some reservations about government promoting a
particular process. But I do think that we need government to
play a role where there is clearly no disagreement about what
needs to be said.
Senator Collins. Thank you.
Mr. Hahn.
Mr. Hahn. I agree that we need to educate medical
professionals, retail food service and also consumers. I think
that the schools are a good place to educate consumers if they
are willing to take on that task and have the kids teach their
parents. Another suggestion that has been made is to have the
Federal Government issue food safety guidelines like the
Dietary Guidelines for Nutrition, and I think that would be a
good idea to have a single source of food safety information
rather than getting the information out in dribs and drabs.
Senator Collins. Thank you.
I want to thank all of the panel for your testimony today.
We do look forward to continuing to work with you. I rather
like Ms. Foreman's idea of bringing all the interested parties
together and locking them into what would have to be a very
large room, I believe, perhaps denying them water and food
until an agreement is reached.
But in all seriousness, our intention is to work with
everyone who is interested on this issue to try to come up with
legislation that would really make a difference in the safety
of the food we eat with particular emphasis on food imported
from other nations because that has been the primary focus of
our investigation.
Again, I thank you very much for your contributions today
and the contributions of the previous panel as well. The
hearing record will remain open for 10 additional days.
I want to take this opportunity to thank my staff which has
worked extremely hard on this investigation. In particular, we
have benefitted from the expertise of a food scientist,
Stephanie Smith, who has been working with us during the past
year. She has been invaluable in bringing to us an
understanding of what risk-based analysis means and bringing us
some scientific expertise to this investigation.
So, I am grateful for the help of Stephanie and, indeed, of
all my staff in this area.
Thank you very much and this hearing is adjourned.
[Whereupon, at 11:53 a.m., the Subcommittee adjourned.]
A P P E N D I X
----------
[GRAPHIC] [TIFF OMITTED] 51562.001
[GRAPHIC] [TIFF OMITTED] 51562.002
[GRAPHIC] [TIFF OMITTED] 51562.003
[GRAPHIC] [TIFF OMITTED] 51562.004
[GRAPHIC] [TIFF OMITTED] 51562.005
[GRAPHIC] [TIFF OMITTED] 51562.006
[GRAPHIC] [TIFF OMITTED] 51562.007
[GRAPHIC] [TIFF OMITTED] 51562.008
[GRAPHIC] [TIFF OMITTED] 51562.009
[GRAPHIC] [TIFF OMITTED] 51562.010
[GRAPHIC] [TIFF OMITTED] 51562.011
[GRAPHIC] [TIFF OMITTED] 51562.012
[GRAPHIC] [TIFF OMITTED] 51562.013
[GRAPHIC] [TIFF OMITTED] 51562.014
[GRAPHIC] [TIFF OMITTED] 51562.015
[GRAPHIC] [TIFF OMITTED] 51562.016
[GRAPHIC] [TIFF OMITTED] 51562.017
[GRAPHIC] [TIFF OMITTED] 51562.018
[GRAPHIC] [TIFF OMITTED] 51562.019
[GRAPHIC] [TIFF OMITTED] 51562.020
[GRAPHIC] [TIFF OMITTED] 51562.021
[GRAPHIC] [TIFF OMITTED] 51562.022
[GRAPHIC] [TIFF OMITTED] 51562.023
[GRAPHIC] [TIFF OMITTED] 51562.024
[GRAPHIC] [TIFF OMITTED] 51562.025
[GRAPHIC] [TIFF OMITTED] 51562.026
[GRAPHIC] [TIFF OMITTED] 51562.027
[GRAPHIC] [TIFF OMITTED] 51562.028
[GRAPHIC] [TIFF OMITTED] 51562.029
[GRAPHIC] [TIFF OMITTED] 51562.030
[GRAPHIC] [TIFF OMITTED] 51562.031
[GRAPHIC] [TIFF OMITTED] 51562.032
[GRAPHIC] [TIFF OMITTED] 51562.033
[GRAPHIC] [TIFF OMITTED] 51562.034
[GRAPHIC] [TIFF OMITTED] 51562.035
[GRAPHIC] [TIFF OMITTED] 51562.036
[GRAPHIC] [TIFF OMITTED] 51562.037
[GRAPHIC] [TIFF OMITTED] 51562.038
[GRAPHIC] [TIFF OMITTED] 51562.039
[GRAPHIC] [TIFF OMITTED] 51562.040
[GRAPHIC] [TIFF OMITTED] 51562.041
[GRAPHIC] [TIFF OMITTED] 51562.042
[GRAPHIC] [TIFF OMITTED] 51562.043
[GRAPHIC] [TIFF OMITTED] 51562.044
[GRAPHIC] [TIFF OMITTED] 51562.045
[GRAPHIC] [TIFF OMITTED] 51562.046
[GRAPHIC] [TIFF OMITTED] 51562.047
[GRAPHIC] [TIFF OMITTED] 51562.048
[GRAPHIC] [TIFF OMITTED] 51562.049
[GRAPHIC] [TIFF OMITTED] 51562.050
[GRAPHIC] [TIFF OMITTED] 51562.051
[GRAPHIC] [TIFF OMITTED] 51562.052
[GRAPHIC] [TIFF OMITTED] 51562.053
[GRAPHIC] [TIFF OMITTED] 51562.054
[GRAPHIC] [TIFF OMITTED] 51562.055
[GRAPHIC] [TIFF OMITTED] 51562.056
[GRAPHIC] [TIFF OMITTED] 51562.057
[GRAPHIC] [TIFF OMITTED] 51562.058
[GRAPHIC] [TIFF OMITTED] 51562.059
[GRAPHIC] [TIFF OMITTED] 51562.060
[GRAPHIC] [TIFF OMITTED] 51562.061
[GRAPHIC] [TIFF OMITTED] 51562.062
[GRAPHIC] [TIFF OMITTED] 51562.063
[GRAPHIC] [TIFF OMITTED] 51562.064
[GRAPHIC] [TIFF OMITTED] 51562.065
[GRAPHIC] [TIFF OMITTED] 51562.066
[GRAPHIC] [TIFF OMITTED] 51562.067
[GRAPHIC] [TIFF OMITTED] 51562.068
[GRAPHIC] [TIFF OMITTED] 51562.069
[GRAPHIC] [TIFF OMITTED] 51562.070
[GRAPHIC] [TIFF OMITTED] 51562.071
[GRAPHIC] [TIFF OMITTED] 51562.072
[GRAPHIC] [TIFF OMITTED] 51562.073
[GRAPHIC] [TIFF OMITTED] 51562.074
[GRAPHIC] [TIFF OMITTED] 51562.075
[GRAPHIC] [TIFF OMITTED] 51562.076
[GRAPHIC] [TIFF OMITTED] 51562.077
[GRAPHIC] [TIFF OMITTED] 51562.078
[GRAPHIC] [TIFF OMITTED] 51562.079
[GRAPHIC] [TIFF OMITTED] 51562.080
[GRAPHIC] [TIFF OMITTED] 51562.081
[GRAPHIC] [TIFF OMITTED] 51562.082
[GRAPHIC] [TIFF OMITTED] 51562.083
[GRAPHIC] [TIFF OMITTED] 51562.084
[GRAPHIC] [TIFF OMITTED] 51562.085
[GRAPHIC] [TIFF OMITTED] 51562.086
[GRAPHIC] [TIFF OMITTED] 51562.087
[GRAPHIC] [TIFF OMITTED] 51562.088
[GRAPHIC] [TIFF OMITTED] 51562.089
[GRAPHIC] [TIFF OMITTED] 51562.090
[GRAPHIC] [TIFF OMITTED] 51562.091
[GRAPHIC] [TIFF OMITTED] 51562.092
[GRAPHIC] [TIFF OMITTED] 51562.093
[GRAPHIC] [TIFF OMITTED] 51562.094
[GRAPHIC] [TIFF OMITTED] 51562.095
[GRAPHIC] [TIFF OMITTED] 51562.096
[GRAPHIC] [TIFF OMITTED] 51562.097
[GRAPHIC] [TIFF OMITTED] 51562.098
[GRAPHIC] [TIFF OMITTED] 51562.099
[GRAPHIC] [TIFF OMITTED] 51562.100
[GRAPHIC] [TIFF OMITTED] 51562.101
[GRAPHIC] [TIFF OMITTED] 51562.102
[GRAPHIC] [TIFF OMITTED] 51562.103
[GRAPHIC] [TIFF OMITTED] 51562.104
[GRAPHIC] [TIFF OMITTED] 51562.105
[GRAPHIC] [TIFF OMITTED] 51562.106
[GRAPHIC] [TIFF OMITTED] 51562.107
[GRAPHIC] [TIFF OMITTED] 51562.108
[GRAPHIC] [TIFF OMITTED] 51562.109
[GRAPHIC] [TIFF OMITTED] 51562.110
[GRAPHIC] [TIFF OMITTED] 51562.111
[GRAPHIC] [TIFF OMITTED] 51562.112
[GRAPHIC] [TIFF OMITTED] 51562.113
[GRAPHIC] [TIFF OMITTED] 51562.114
[GRAPHIC] [TIFF OMITTED] 51562.115
[GRAPHIC] [TIFF OMITTED] 51562.116
[GRAPHIC] [TIFF OMITTED] 51562.117
[GRAPHIC] [TIFF OMITTED] 51562.118
[GRAPHIC] [TIFF OMITTED] 51562.119
[GRAPHIC] [TIFF OMITTED] 51562.120
[GRAPHIC] [TIFF OMITTED] 51562.121
[GRAPHIC] [TIFF OMITTED] 51562.122
[GRAPHIC] [TIFF OMITTED] 51562.123
[GRAPHIC] [TIFF OMITTED] 51562.124
[GRAPHIC] [TIFF OMITTED] 51562.125
[GRAPHIC] [TIFF OMITTED] 51562.126
[GRAPHIC] [TIFF OMITTED] 51562.127
[GRAPHIC] [TIFF OMITTED] 51562.128
[GRAPHIC] [TIFF OMITTED] 51562.129
[GRAPHIC] [TIFF OMITTED] 51562.130
[GRAPHIC] [TIFF OMITTED] 51562.131
[GRAPHIC] [TIFF OMITTED] 51562.132
[GRAPHIC] [TIFF OMITTED] 51562.133
[GRAPHIC] [TIFF OMITTED] 51562.134
[GRAPHIC] [TIFF OMITTED] 51562.135
[GRAPHIC] [TIFF OMITTED] 51562.136
[GRAPHIC] [TIFF OMITTED] 51562.137
[GRAPHIC] [TIFF OMITTED] 51562.138
[GRAPHIC] [TIFF OMITTED] 51562.139
[GRAPHIC] [TIFF OMITTED] 51562.140
[GRAPHIC] [TIFF OMITTED] 51562.141
[GRAPHIC] [TIFF OMITTED] 51562.142
[GRAPHIC] [TIFF OMITTED] 51562.143
[GRAPHIC] [TIFF OMITTED] 51562.144
[GRAPHIC] [TIFF OMITTED] 51562.145
[GRAPHIC] [TIFF OMITTED] 51562.146
[GRAPHIC] [TIFF OMITTED] 51562.147
[GRAPHIC] [TIFF OMITTED] 51562.148
[GRAPHIC] [TIFF OMITTED] 51562.149
[GRAPHIC] [TIFF OMITTED] 51562.150
[GRAPHIC] [TIFF OMITTED] 51562.151
[GRAPHIC] [TIFF OMITTED] 51562.152
[GRAPHIC] [TIFF OMITTED] 51562.153
[GRAPHIC] [TIFF OMITTED] 51562.154
[GRAPHIC] [TIFF OMITTED] 51562.155
[GRAPHIC] [TIFF OMITTED] 51562.156
[GRAPHIC] [TIFF OMITTED] 51562.157
[GRAPHIC] [TIFF OMITTED] 51562.158
[GRAPHIC] [TIFF OMITTED] 51562.159
[GRAPHIC] [TIFF OMITTED] 51562.160
[GRAPHIC] [TIFF OMITTED] 51562.161
[GRAPHIC] [TIFF OMITTED] 51562.162
[GRAPHIC] [TIFF OMITTED] 51562.163
[GRAPHIC] [TIFF OMITTED] 51562.164
[GRAPHIC] [TIFF OMITTED] 51562.165
[GRAPHIC] [TIFF OMITTED] 51562.166
[GRAPHIC] [TIFF OMITTED] 51562.167
[GRAPHIC] [TIFF OMITTED] 51562.168
[GRAPHIC] [TIFF OMITTED] 51562.169
[GRAPHIC] [TIFF OMITTED] 51562.170
[GRAPHIC] [TIFF OMITTED] 51562.171
[GRAPHIC] [TIFF OMITTED] 51562.172
[GRAPHIC] [TIFF OMITTED] 51562.173
[GRAPHIC] [TIFF OMITTED] 51562.174
[GRAPHIC] [TIFF OMITTED] 51562.175
[GRAPHIC] [TIFF OMITTED] 51562.176
[GRAPHIC] [TIFF OMITTED] 51562.177
[GRAPHIC] [TIFF OMITTED] 51562.178
[GRAPHIC] [TIFF OMITTED] 51562.179
[GRAPHIC] [TIFF OMITTED] 51562.180
[GRAPHIC] [TIFF OMITTED] 51562.181
[GRAPHIC] [TIFF OMITTED] 51562.182
[GRAPHIC] [TIFF OMITTED] 51562.183
[GRAPHIC] [TIFF OMITTED] 51562.184
[GRAPHIC] [TIFF OMITTED] 51562.185
[GRAPHIC] [TIFF OMITTED] 51562.186
[GRAPHIC] [TIFF OMITTED] 51562.187
[GRAPHIC] [TIFF OMITTED] 51562.188
[GRAPHIC] [TIFF OMITTED] 51562.189
[GRAPHIC] [TIFF OMITTED] 51562.190
[GRAPHIC] [TIFF OMITTED] 51562.191
[GRAPHIC] [TIFF OMITTED] 51562.192
[GRAPHIC] [TIFF OMITTED] 51562.193
[GRAPHIC] [TIFF OMITTED] 51562.194
[GRAPHIC] [TIFF OMITTED] 51562.195
[GRAPHIC] [TIFF OMITTED] 51562.196
[GRAPHIC] [TIFF OMITTED] 51562.197
[GRAPHIC] [TIFF OMITTED] 51562.198
[GRAPHIC] [TIFF OMITTED] 51562.199
[GRAPHIC] [TIFF OMITTED] 51562.200
[GRAPHIC] [TIFF OMITTED] 51562.201
[GRAPHIC] [TIFF OMITTED] 51562.202
[GRAPHIC] [TIFF OMITTED] 51562.203
[GRAPHIC] [TIFF OMITTED] 51562.204
[GRAPHIC] [TIFF OMITTED] 51562.205
[GRAPHIC] [TIFF OMITTED] 51562.206
[GRAPHIC] [TIFF OMITTED] 51562.207
[GRAPHIC] [TIFF OMITTED] 51562.208
[GRAPHIC] [TIFF OMITTED] 51562.209
[GRAPHIC] [TIFF OMITTED] 51562.210
[GRAPHIC] [TIFF OMITTED] 51562.211
[GRAPHIC] [TIFF OMITTED] 51562.212
[GRAPHIC] [TIFF OMITTED] 51562.213
[GRAPHIC] [TIFF OMITTED] 51562.214
[GRAPHIC] [TIFF OMITTED] 51562.215
[GRAPHIC] [TIFF OMITTED] 51562.216
[GRAPHIC] [TIFF OMITTED] 51562.217
[GRAPHIC] [TIFF OMITTED] 51562.218
[GRAPHIC] [TIFF OMITTED] 51562.219
[GRAPHIC] [TIFF OMITTED] 51562.220
[GRAPHIC] [TIFF OMITTED] 51562.221
[GRAPHIC] [TIFF OMITTED] 51562.222
[GRAPHIC] [TIFF OMITTED] 51562.223
[GRAPHIC] [TIFF OMITTED] 51562.224
[GRAPHIC] [TIFF OMITTED] 51562.225
[GRAPHIC] [TIFF OMITTED] 51562.226
[GRAPHIC] [TIFF OMITTED] 51562.227
[GRAPHIC] [TIFF OMITTED] 51562.228
[GRAPHIC] [TIFF OMITTED] 51562.229
[GRAPHIC] [TIFF OMITTED] 51562.230
[GRAPHIC] [TIFF OMITTED] 51562.231
[GRAPHIC] [TIFF OMITTED] 51562.232
[GRAPHIC] [TIFF OMITTED] 51562.233
[GRAPHIC] [TIFF OMITTED] 51562.234
[GRAPHIC] [TIFF OMITTED] 51562.235
[GRAPHIC] [TIFF OMITTED] 51562.236
[GRAPHIC] [TIFF OMITTED] 51562.237
[GRAPHIC] [TIFF OMITTED] 51562.238
[GRAPHIC] [TIFF OMITTED] 51562.239
[GRAPHIC] [TIFF OMITTED] 51562.240
[GRAPHIC] [TIFF OMITTED] 51562.241
[GRAPHIC] [TIFF OMITTED] 51562.242
[GRAPHIC] [TIFF OMITTED] 51562.243
[GRAPHIC] [TIFF OMITTED] 51562.244
[GRAPHIC] [TIFF OMITTED] 51562.245
[GRAPHIC] [TIFF OMITTED] 51562.246
[GRAPHIC] [TIFF OMITTED] 51562.247
[GRAPHIC] [TIFF OMITTED] 51562.248
[GRAPHIC] [TIFF OMITTED] 51562.249
[GRAPHIC] [TIFF OMITTED] 51562.250
[GRAPHIC] [TIFF OMITTED] 51562.251
[GRAPHIC] [TIFF OMITTED] 51562.252
[GRAPHIC] [TIFF OMITTED] 51562.253
[GRAPHIC] [TIFF OMITTED] 51562.254
[GRAPHIC] [TIFF OMITTED] 51562.255
[GRAPHIC] [TIFF OMITTED] 51562.256
[GRAPHIC] [TIFF OMITTED] 51562.257
[GRAPHIC] [TIFF OMITTED] 51562.258
[GRAPHIC] [TIFF OMITTED] 51562.259
[GRAPHIC] [TIFF OMITTED] 51562.260
[GRAPHIC] [TIFF OMITTED] 51562.261
[GRAPHIC] [TIFF OMITTED] 51562.262
[GRAPHIC] [TIFF OMITTED] 51562.263
[GRAPHIC] [TIFF OMITTED] 51562.264
[GRAPHIC] [TIFF OMITTED] 51562.265
[GRAPHIC] [TIFF OMITTED] 51562.266
[GRAPHIC] [TIFF OMITTED] 51562.267
[GRAPHIC] [TIFF OMITTED] 51562.268
[GRAPHIC] [TIFF OMITTED] 51562.269
[GRAPHIC] [TIFF OMITTED] 51562.270
[GRAPHIC] [TIFF OMITTED] 51562.271
[GRAPHIC] [TIFF OMITTED] 51562.272
[GRAPHIC] [TIFF OMITTED] 51562.273
[GRAPHIC] [TIFF OMITTED] 51562.274
[GRAPHIC] [TIFF OMITTED] 51562.275
[GRAPHIC] [TIFF OMITTED] 51562.276
[GRAPHIC] [TIFF OMITTED] 51562.277
[GRAPHIC] [TIFF OMITTED] 51562.278
[GRAPHIC] [TIFF OMITTED] 51562.279
[GRAPHIC] [TIFF OMITTED] 51562.280
[GRAPHIC] [TIFF OMITTED] 51562.281
[GRAPHIC] [TIFF OMITTED] 51562.282
[GRAPHIC] [TIFF OMITTED] 51562.283
[GRAPHIC] [TIFF OMITTED] 51562.284
[GRAPHIC] [TIFF OMITTED] 51562.285
[GRAPHIC] [TIFF OMITTED] 51562.286
[GRAPHIC] [TIFF OMITTED] 51562.287
[GRAPHIC] [TIFF OMITTED] 51562.288
[GRAPHIC] [TIFF OMITTED] 51562.289
[GRAPHIC] [TIFF OMITTED] 51562.290
[GRAPHIC] [TIFF OMITTED] 51562.291
[GRAPHIC] [TIFF OMITTED] 51562.292
[GRAPHIC] [TIFF OMITTED] 51562.293
[GRAPHIC] [TIFF OMITTED] 51562.294
[GRAPHIC] [TIFF OMITTED] 51562.295
[GRAPHIC] [TIFF OMITTED] 51562.296
[GRAPHIC] [TIFF OMITTED] 51562.297
[GRAPHIC] [TIFF OMITTED] 51562.298
[GRAPHIC] [TIFF OMITTED] 51562.299
[GRAPHIC] [TIFF OMITTED] 51562.300
[GRAPHIC] [TIFF OMITTED] 51562.301
[GRAPHIC] [TIFF OMITTED] 51562.302
[GRAPHIC] [TIFF OMITTED] 51562.303
[GRAPHIC] [TIFF OMITTED] 51562.304
[GRAPHIC] [TIFF OMITTED] 51562.305
[GRAPHIC] [TIFF OMITTED] 51562.306
[GRAPHIC] [TIFF OMITTED] 51562.307
[GRAPHIC] [TIFF OMITTED] 51562.308
[GRAPHIC] [TIFF OMITTED] 51562.309
[GRAPHIC] [TIFF OMITTED] 51562.310
[GRAPHIC] [TIFF OMITTED] 51562.311
[GRAPHIC] [TIFF OMITTED] 51562.312
[GRAPHIC] [TIFF OMITTED] 51562.313
[GRAPHIC] [TIFF OMITTED] 51562.314
[GRAPHIC] [TIFF OMITTED] 51562.315
[GRAPHIC] [TIFF OMITTED] 51562.316
[GRAPHIC] [TIFF OMITTED] 51562.317
[GRAPHIC] [TIFF OMITTED] 51562.318
[GRAPHIC] [TIFF OMITTED] 51562.319
[GRAPHIC] [TIFF OMITTED] 51562.320
[GRAPHIC] [TIFF OMITTED] 51562.321
[GRAPHIC] [TIFF OMITTED] 51562.322
[GRAPHIC] [TIFF OMITTED] 51562.323
[GRAPHIC] [TIFF OMITTED] 51562.324
[GRAPHIC] [TIFF OMITTED] 51562.325
[GRAPHIC] [TIFF OMITTED] 51562.326
[GRAPHIC] [TIFF OMITTED] 51562.327
[GRAPHIC] [TIFF OMITTED] 51562.328
[GRAPHIC] [TIFF OMITTED] 51562.329
[GRAPHIC] [TIFF OMITTED] 51562.330
[GRAPHIC] [TIFF OMITTED] 51562.331
[GRAPHIC] [TIFF OMITTED] 51562.332
[GRAPHIC] [TIFF OMITTED] 51562.333
[GRAPHIC] [TIFF OMITTED] 51562.334
[GRAPHIC] [TIFF OMITTED] 51562.335
[GRAPHIC] [TIFF OMITTED] 51562.336
[GRAPHIC] [TIFF OMITTED] 51562.337
[GRAPHIC] [TIFF OMITTED] 51562.338
[GRAPHIC] [TIFF OMITTED] 51562.339
[GRAPHIC] [TIFF OMITTED] 51562.340
[GRAPHIC] [TIFF OMITTED] 51562.341
[GRAPHIC] [TIFF OMITTED] 51562.342
[GRAPHIC] [TIFF OMITTED] 51562.343
[GRAPHIC] [TIFF OMITTED] 51562.344
[GRAPHIC] [TIFF OMITTED] 51562.345
[GRAPHIC] [TIFF OMITTED] 51562.346
[GRAPHIC] [TIFF OMITTED] 51562.347
[GRAPHIC] [TIFF OMITTED] 51562.348
[GRAPHIC] [TIFF OMITTED] 51562.349
[GRAPHIC] [TIFF OMITTED] 51562.350
[GRAPHIC] [TIFF OMITTED] 51562.351
[GRAPHIC] [TIFF OMITTED] 51562.352
[GRAPHIC] [TIFF OMITTED] 51562.353
[GRAPHIC] [TIFF OMITTED] 51562.354
[GRAPHIC] [TIFF OMITTED] 51562.355
[GRAPHIC] [TIFF OMITTED] 51562.356
[GRAPHIC] [TIFF OMITTED] 51562.357
[GRAPHIC] [TIFF OMITTED] 51562.358
[GRAPHIC] [TIFF OMITTED] 51562.359
[GRAPHIC] [TIFF OMITTED] 51562.360
[GRAPHIC] [TIFF OMITTED] 51562.361
[GRAPHIC] [TIFF OMITTED] 51562.362
[GRAPHIC] [TIFF OMITTED] 51562.363
[GRAPHIC] [TIFF OMITTED] 51562.364
[GRAPHIC] [TIFF OMITTED] 51562.365
[GRAPHIC] [TIFF OMITTED] 51562.366
[GRAPHIC] [TIFF OMITTED] 51562.367
[GRAPHIC] [TIFF OMITTED] 51562.368
[GRAPHIC] [TIFF OMITTED] 51562.369
[GRAPHIC] [TIFF OMITTED] 51562.370
[GRAPHIC] [TIFF OMITTED] 51562.371
[GRAPHIC] [TIFF OMITTED] 51562.372
[GRAPHIC] [TIFF OMITTED] 51562.373
[GRAPHIC] [TIFF OMITTED] 51562.374