Salvaged Food: Lessons Learned from the Americold Fire (Letter Report,
03/08/95, GAO/RCED-95-76).
Pursuant to a congressional request, GAO provided information on the
events surrounding a fire at a food storage warehouse in Kansas,
focusing on the: (1) disposition of food salvaged from the facility; and
(2) lessons learned from the incident that could be used to improve
regulation of the food salvaging industry.
GAO found that: (1) over half of the affected food was destroyed and the
remaining 102 million pounds of food was released to the public after
Kansas determined its salvageability; (2) about 3.7 million pounds of
food was shipped to a salvager on the basis of laboratory results
furnished by a consultant who was under investigation by the Food and
Drug Administration (FDA); (3) although no illnesses were attributed to
the food salvaged from the Kansas fire, potential public health risks
were increased by shortcomings in FDA regulation of salvaged food; (4)
FDA did not share important information with Kansas regarding its past
problems with the consultant and his laboratories; and (5) FDA did not
provide Kansas with guidance on food sampling controls that would have
been useful in its oversight of the salvaging.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: RCED-95-76
TITLE: Salvaged Food: Lessons Learned from the Americold Fire
DATE: 03/08/95
SUBJECT: Food inspection
Contaminated foods
Food facilities
Carcinogens
Federal/state relations
Consultants
Hazardous substances
Safety standards
Safety regulation
Health hazards
IDENTIFIER: Kansas
Kansas City (KS)
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Cover
================================================================ COVER
Report to the Ranking Minority Member, Committee on Commerce, House
of Representatives
March 1995
SALVAGED FOOD - LESSONS LEARNED
FROM THE AMERICOLD FIRE
GAO/RCED-95-76
Food Salvaged From the Americold Fire
Abbreviations
=============================================================== ABBREV
FDA - Food and Drug Administration
GAO - General Accounting Office
KDHE - Kansas Department of Health
USDA - United States Department of Agriculture
Letter
=============================================================== LETTER
B-259724
March 8, 1995
The Honorable John D. Dingell
Ranking Minority Member
Committee on Commerce
House of Representatives
Dear Mr. Dingell:
Every year, millions of pounds of food is damaged or contaminated as
a result of mishandling, accidents, or disasters, such as floods or
fires. Such a disaster occurred in December 1991, when an
underground fire potentially contaminated about 245 million pounds of
food in the Americold storage cave in Kansas City, Kansas. Concerned
about the efforts made to salvage the food after the fire, you asked
us to review federal and state regulation of the food salvaging
industry.
As agreed with your office, we have (1) described the events
surrounding the Americold fire, particularly the disposition of the
food removed from the storage facility, and (2) identified lessons
learned from this incident that could be used to improve federal and
state regulation of food salvaging.
RESULTS IN BRIEF
------------------------------------------------------------ Letter :1
Over half the food affected by the Americold fire was sent to
landfills to be destroyed. The remainder, about 102 million pounds
of food, was found to be salvageable by the Kansas Department of
Health and the Environment and was released to the public. Of this
total, about 3.7 million pounds was shipped to a Minnesota food
salvager on the basis of laboratory results from a consultant to one
of the food owners. It was later learned that this consultant had
been under investigation for submitting false testing data to the
Food and Drug Administration (FDA). All but about 100,000 pounds of
this shipped food was eventually sold to the public.
In reviewing events following the Americold fire, we found
opportunities for FDA to be more proactive in helping states manage
food salvaging following major disasters. Although no illnesses were
attributed to the food salvaged from the Kansas fire, the potential
risk to public health was increased because of FDA's shortcomings.
Specifically, FDA did not adequately share important information it
had about past problems it had experienced with the capability and
performance of the consultant discussed above and his laboratories.
The consultant's laboratory test results were used to demonstrate to
Kansas officials the safety of salvaged food later released to the
public. In addition, FDA did not provide guidance on needed food
sampling controls to the Kansas officials responsible for overseeing
the salvaging.\1 FDA uses such guidance internally to ensure the
credibility, accuracy, and reliability of analytical data from
private laboratories.
--------------------
\1 Food sampling involves selecting, securing, and preserving
products for private laboratories' scientific analysis of levels of
chemical residues.
REGULATION OF THE FOOD
SALVAGING INDUSTRY
------------------------------------------------------------ Letter :2
During the storage and distribution of the billions of pounds of food
consumed annually in the United States, some food is damaged or
contaminated because of mishandling, accidents (e.g., fires,
explosions, or truck and train accidents), or natural and man-made
disasters (e.g., earthquakes, hurricanes, floods, or riots). Food
that is adulterated or contaminated is generally destroyed. However,
if the food is determined to be safe, it may be salvaged and
"reconditioned" for consumption.
Both FDA and the U.S. Department of Agriculture (USDA) are
responsible for ensuring that all food shipped or received in
interstate commerce is safe for consumption.\2 FDA enters into
contracts or initiates cooperative agreements with state authorities
to inspect food manufacturers and warehouses, including operations to
salvage food. According to FDA officials, state and local
authorities are the most effective regulatory bodies for monitoring
such operations because (1) FDA has no authority to place an embargo
on hazardous food;\3 (2) the states have intensive regulatory
coverage of food warehouses and retail establishments, where most
food salvaging operations occur; and (3) FDA has concentrated its
resources on issues that pose a higher risk to public health, such as
monitoring the blood supply and the safety of medical devices. USDA
directly monitors meat and poultry salvaging operations using its own
inspectors or designates states to perform inspections when they have
inspection programs that meet requirements at least equal to federal
laws.
When a major disaster occurs, states may contact FDA and/or USDA
field offices for assistance and advice. However, FDA's operational
procedures state that in unusual circumstances, such as those
involving the interstate movement of merchandise or areas in which
state or local political ramifications are anticipated, FDA may
assume the primary role in overseeing salvaging operations.
--------------------
\2 FDA derives its authority from the Food, Drug, and Cosmetic Act
(21 U.S.C. 301). USDA is responsible for regulating the salvaging
of meat and poultry products under authority of the Federal Meat
Inspection Act (21 U.S.C. 601) and the Poultry Products Inspection
Act (21 U.S.C. 451).
\3 An embargo is an order preventing further distribution of the
product.
EVENTS SURROUNDING THE
AMERICOLD FIRE
------------------------------------------------------------ Letter :3
On December 28, 1991, a major disaster occurred when a fire began in
a storage cave of approximately 100 acres owned by Americold Services
Corporation in Kansas City, Kansas. This man-made limestone cave is
the largest underground food storage facility in the world, with
freezers, coolers, and dry storage areas accessible by truck and
rail. Figure 1 shows the layout of the Americold cave, including the
location of the fire.
When the fire began, about 245 million pounds of food was stored in
the cave. Of that amount, about 159 million pounds was owned by
about 110 private food companies; USDA owned the remaining 86 million
pounds. The products stored in the cave included dry milk, cheese,
butter, fruit, nuts, and other dry goods, as well as canned and
frozen meats, vegetables, and fruits.
The fire started in an area of the cave containing grocery items,
including cleaning compounds, pesticides, paper goods, and cooking
oil. The fire reached temperatures approaching 2,000 degrees
Fahrenheit and, despite continuous fire-fighting efforts, burned for
about 2 months. (See fig. 2.) The fire was confined to one section
of the cave, but smoke flowed throughout the cave, exposing food to
smoke residue for a prolonged period. According to FDA, this event
was unique in that no other fire had involved such a large quantity
of food that was exposed to smoke for such a long time.
Figure 1: Layout of the
Americold Cave
(See figure in printed
edition.)
Source: Based on an
illustration in The Kansas City
Star .
(See figure in printed
edition.)
(See figure in printed edition.)Figure 2: Smoke Coming From an
Entrance to the Americold Cave
Source: The Kansas City Star.
Following the fire, the Kansas Department of Health and the
Environment (KDHE) met with FDA and other federal, state, and local
agencies to determine a course of action for protecting the public
health and supervising the salvaging operations. It was decided that
KDHE should take the lead in overseeing the salvaging, with
assistance from FDA's district office in Kansas City. Such an
arrangement is typical in routine salvaging operations.
According to FDA's records, contaminants found in the air and on
surfaces in the cave included toluene, benzene, and
phenol--substances cited by the Environmental Protection Agency as
being carcinogenic and causing genetic changes and mutations.
Because of the potential risk to public health from these
contaminants, KDHE, with advice from FDA, placed an embargo on all of
the stored food. The embargo was to continue until the owners of the
food presented KDHE with evidence, based on laboratory analysis, that
the food was suitable for consumption.
In many instances, ownership of the food transferred to insurance
companies and, ultimately, to food salvagers. The insurers and
salvagers were eager to begin salvaging operations and, according to
KDHE officials, placed pressure on KDHE to release the food. The
salvaging operations began almost immediately and continued for over
2 years. Table 1 summarizes the final disposition of the food stored
in the cave.
Table 1
Disposition of Food Stored in Americold
Cave as of June 1994
(Pounds of food in millions)
Owner Destroyed Total
------------------- -------------------- --------- ------
Private 82.4 76.3 158.7
USDA 19.3 67.2 86.5
============================================================
Total 101.7 143.5 245.2
------------------------------------------------------------
Sources: KDHE's and USDA's records.
Over 143 million pounds of food was sent to landfills to be
destroyed, and about 102 million pounds was released for
reconditioning and consumption.
Most of the 102 million pounds of food salvaged from the fire was
released to the public with little apparent controversy. However, in
December 1993, about 2 years after the fire began, a series of
articles in the Kansas City Star raised questions about the release
of food to a Minnesota food salvager. About 3.7 million pounds of
food was shipped to this salvager, and all but about 100,000 pounds
was eventually sold to the public. Appendix I provides a chronology
of the key events in the release of the food to this salvager.
INADEQUACIES IN FDA'S
ASSISTANCE TO KDHE: NEED FOR A
MORE PROACTIVE ROLE FOR FDA
------------------------------------------------------------ Letter :4
Our review of food salvaging activities following the
fire--particularly those involving the shipment of food to
Minnesota--found two problems from which lessons can be learned to
improve future salvaging operations. First, FDA did not adequately
share information with KDHE about past problems it had experienced
with a food owner's consultant and his laboratories. This
consultant's laboratory test results were used to demonstrate to KDHE
the safety of food later released to the public. Second, FDA did not
communicate its guidance on food sampling to the KDHE officials
responsible for overseeing the salvaging operations. FDA relies on
such guidance internally to ensure the integrity of analytical data
from private laboratories. Both of these problems suggest the need
for FDA to be more proactive in helping states manage food salvaging
following major disasters.
FDA DID NOT ADEQUATELY
COMMUNICATE IMPORTANT
INFORMATION ABOUT CONSULTANT
AND LABORATORIES
---------------------------------------------------------- Letter :4.1
KDHE allowed several million pounds of food salvaged from the
Americold fire to be sent to Minnesota on the basis of laboratory
results submitted by a consultant to one of the food owners. KDHE
officials subsequently learned from FDA that this consultant and his
laboratories had been under investigation by FDA and that two of his
laboratories were on FDA's "nonacceptance" list. However, FDA did
not provide this information in a timely manner either to its Kansas
City District Office or to the KDHE investigators overseeing the
salvaging of the food.
In April 1992, KDHE asked FDA's Kansas City District Office for
advice on the consultant's plans for sampling and testing food that
had been stored in the Americold cave. The consultant had been hired
by a food owner to sample and test the food for chemical and smoke
residues. FDA's district office raised several concerns about the
consultant's plans. However, it provided no information to KDHE
about the past performance of the consultant or his laboratories.
This information was known within FDA but was not shared with the FDA
investigator advising KDHE.
FDA's Division of Field Science in Washington, D.C., maintains and
periodically distributes to FDA district offices a "nonacceptance"
list of some private laboratories. According to FDA officials, the
list provides information about private laboratories that at least
one FDA district office has found to be unacceptable for performing
certain or all analytical tests. FDA's district offices may use this
information in deciding whether to accept or reject analyses from a
particular laboratory. Much of this information is based on
enforcement activities in FDA's program for monitoring imported food.
FDA's information indicated that two of the consultant's laboratories
were unacceptable for performing any analyses.
The investigator from FDA's district office said that he was unaware
that such a list existed until June 13, 1992, when he learned of it
from a visiting FDA scientist. A month later, he advised KDHE not to
accept test results from the consultant's laboratories. However, the
consultant informed KDHE that the analyses were being performed by
another laboratory that KDHE, on the basis of discussions with the
Minnesota Department of Agriculture, had determined to be reputable.
This laboratory was not affiliated with the consultant. On the basis
of this information and subsequent laboratory results indicating that
the tested food was not contaminated, KDHE allowed the food to be
shipped, under embargo, to a Minnesota salvager. KDHE officials
later learned from FDA that the consultant himself was the subject of
an ongoing FDA investigation concerning the falsification of
laboratory data. They said that if they had known this earlier, they
would not have allowed the food to be shipped to Minnesota.
After the food shipments to Minnesota began, the Minnesota Department
of Agriculture asked FDA to test a truckload of cheese. Minnesota
state food inspectors were concerned because the containers were
covered with dust and smelled of smoke. FDA's test results showed
that some hazardous chemicals, including toluene, were present in the
cheese. However, according to an FDA official, the levels of
chemicals found did not pose a health hazard. The remaining food
held by the salvager was retested by a private laboratory, judged to
be safe for consumption, and eventually sold to the public.
Officials from KDHE and the Minnesota Department of Agriculture told
us that no illnesses have been attributed to this food.
FDA DID NOT ADEQUATELY
COMMUNICATE ITS GUIDANCE ON
FOOD SAMPLING
---------------------------------------------------------- Letter :4.2
FDA has published guidance on food sampling to ensure the
credibility, accuracy, and reliability of analytical data from
private laboratories. This guidance, which primarily concerns FDA's
regulation of imported foods, was provided to KDHE's state
laboratory\4 but not to the KDHE officials managing the food
salvaging operations.
The food sampling processes KDHE used in the salvaging operations
following the fire lacked some important controls, thereby creating
the risk that unsafe food might be released to the public. For
example, food owners selected food samples without a KDHE official or
other disinterested third party present. In addition, the consultant
discussed earlier maintained control over food samples that were to
be tested for chemical residues.
Although it has no legislative regulatory authority over private
laboratories, FDA has internal guidance to help ensure that
laboratories performing analyses of FDA-regulated commodities submit
scientifically sound data. In March 1992, FDA provided Kansas with
its Laboratory Procedures Manual, which spells out recommended
sampling controls that FDA uses in monitoring imported foods. Among
other things, the guidance recommends that scientific data supplied
by private laboratories be obtained by using sound methods of
sampling and analysis and that sampling be performed by a
disinterested, objective third party.
The KDHE officials responsible for overseeing the food salvaging
operations said, however, that they were not aware of this guidance
because it had been provided only to KDHE's state laboratory. They
also noted that the FDA officials assisting them had not brought this
guidance to their attention. They said that if they had been aware
of the guidance, they would have required all food owners to hire a
disinterested third party to perform food sampling and ensured that
the chain of custody over food samples was secured.
In discussing FDA's participation in overseeing the salvaging
activities following the Americold fire, FDA officials said they
viewed their role as limited to that of a consultant. According to
one FDA official, FDA's role was limited to providing information to
KDHE when requested, and FDA was not to anticipate what issues needed
to be addressed.
--------------------
\4 KDHE's Health and Environment Laboratory is a separate department
within KDHE, with its own director.
CONCLUSIONS
------------------------------------------------------------ Letter :5
KDHE had to make decisions about the release of potentially
contaminated food under stressful conditions, including pressure from
food owners to expeditiously release the food for salvaging. KDHE
relied on FDA, which has considerable experience in dealing with food
safety issues, for advice and guidance. However, although the
Americold fire was a major disaster with potentially serious
consequences resulting from the release of improperly tested food,
FDA continued to view its role as that of a consultant--
primarily responding to specific requests from KDHE for advice.
Such an interpretation may be appropriate for routine salvaging
activities; however, this was not a routine operation. Over the
years, FDA has developed considerable nationwide experience and
expertise in food safety. We believe that in future disasters of
this magnitude, in which so much is at stake and improper decisions
can adversely affect food safety, FDA should proactively draw upon
this expertise and provide stronger leadership in working with states
to maintain the safety of the food supply.
RECOMMENDATIONS
------------------------------------------------------------ Letter :6
We recommend that FDA more actively assist states in managing food
salvaging operations following major disasters. At a minimum, FDA
should ensure that (1) the information it has about private food
testing laboratories and key personnel is communicated to state
officials responsible for monitoring food salvaging operations after
a major disaster and (2) these state officials are made aware of
FDA's guidance for maintaining the integrity of the food sampling
process.
AGENCY COMMENTS AND OUR
RESPONSE
------------------------------------------------------------ Letter :7
In commenting on a draft of this report, FDA disagreed with our
conclusions and recommendations. FDA described the assistance it
provided KDHE and said it had worked very closely with KDHE officials
to ensure that the public health was protected and that unsafe food
did not reach consumers. FDA stated that following a series of
meetings, it was agreed that KDHE was the agency most suited to take
the lead in the day-to-day supervision of the salvaging operations
and that FDA's Kansas City District Office would support KDHE in any
way required. Overall, FDA said it believed its actions in assisting
KDHE were correct and appropriate.
With regard to our first recommendation, FDA stated that it would be
inappropriate to routinely distribute its "nonacceptance" list of
private laboratories to states, noting that (1) FDA does not have a
regulatory mechanism for declaring a laboratory or analyst
unacceptable, (2) the list could be misconstrued and used
inappropriately, and (3) more aggressive distribution of the list
could jeopardize FDA's ability to maintain and internally disseminate
information about the laboratories' performance.
With regard to our second recommendation--ensuring that appropriate
state officials are made aware of FDA's guidance on food
sampling--FDA said it had provided KDHE with this guidance. FDA
maintained that it is the state agency's responsibility to ensure
that individual employees receive copies of pertinent FDA documents.
We recognize that FDA supported KDHE in dealing with the salvaging
operations subsequent to the Americold fire and have added
information to the report to more fully describe the nature of that
assistance. However, we continue to believe that lessons learned
from the Americold experience can make FDA's support more effective
in future disasters--the overall lesson being that FDA needs to
provide stronger, more proactive leadership in assisting states in
the aftermath of major disasters.
Our report notes that KDHE took the lead in overseeing salvaging
operations, with FDA's Kansas City District Office acting in a
consultant's role--primarily responding to requests from KDHE for
assistance--and that such an arrangement was typical in routine
salvaging operations. However, the Americold fire and the subsequent
salvaging operations were not routine. As FDA itself noted, "this
event was unique in that no other fire has involved such a large
quantity of food that was exposed to smoke for such a prolonged
period of time." It may be appropriate, in routine circumstances, for
FDA to wait until states seek advisory information from it. However,
in major disasters, we believe that FDA needs to draw upon its
nationwide experience and expertise in food safety and more
proactively provide relevant information to state officials
responsible for dealing with such an event.
Regarding our recommendation that FDA share with states information
about private laboratories and key personnel, we recognize that FDA's
"nonacceptance" list is not intended to be a means of certifying a
laboratory or declaring it unacceptable and that FDA believes it has
no regulatory authority to do so. Furthermore, we understand FDA's
concern that aggressive dissemination of the list could result in
inappropriate use of the information on it. Nevertheless, as
discussed in our report, the list may contain information of great
relevance to state officials making critical decisions affecting the
safety of the food supply.
To balance the risk of further disseminating FDA's list with that of
withholding potentially important information on it, we have worded
our recommendation to say that following major disasters, FDA should
communicate information it has about private food testing
laboratories and key personnel to state officials responsible for
monitoring food salvaging operations. Thus, we are not recommending
that the list itself be disseminated, but rather information on the
list as well as any other relevant information about the performance
of laboratories and key personnel. The form in which FDA wishes to
convey this information, as well as any caveats attached to it, is
left to FDA's discretion. Under these circumscribed conditions, we
believe that FDA can maintain adequate control over the information
to ensure that it is not inappropriately used.
With regard to our second recommendation concerning communicating
FDA's guidance on food sampling to appropriate state officials, FDA
explained that it had provided its Laboratory Procedures Manual,
containing guidance on food sampling controls, to KDHE's state
laboratory, which was not directly involved in food salvaging
following the Americold fire. The KDHE officials who were overseeing
the salvaging operations were unaware of this guidance, and FDA did
not bring it to their attention. We believe that FDA officials
assisting states in major disasters should take the initiative to
ensure that state officials who are managing the food salvaging
operations be made aware of key FDA guidance, such as that pertaining
to the food sampling process.
Appendix II contains the complete text of FDA's comments, along with
our responses.
SCOPE AND METHODOLOGY
------------------------------------------------------------ Letter :8
To obtain information on the food salvaging that occurred after the
Americold fire and to identify the lessons learned, we interviewed
FDA officials in Washington, D.C., Kansas, and Minnesota; USDA
officials in Washington, D.C., and Kansas; and state health officials
in Kansas and Minnesota. In addition, we interviewed a food salvager
located in Minnesota. We reviewed FDA, USDA, and state records on
the Americold fire at the locations listed above. We also reviewed
laws and regulations applicable to food salvaging. We conducted our
review from June 1994 through January 1995 in accordance with
generally accepted government auditing standards.
---------------------------------------------------------- Letter :8.1
As arranged with your office, unless you publicly announce its
contents earlier, we plan no further distribution of this report
until 15 days after the date of this letter. At that time, we will
provide copies to the appropriate agency heads and interested
congressional committees. We
Please call me at (202) 512-5138 if you or your staff have any
questions. Major contributors to this report are listed in appendix
III.
Sincerely yours,
John W. Harman
Director, Food and
Agriculture Issues
CHRONOLOGY OF EVENTS SURROUNDING
FOOD SHIPMENTS TO MINNESOTA
SALVAGER
=========================================================== Appendix I
MARCH 1992
------------------------------------------------------- Appendix I:0.1
The owner of 3.7 million pounds of food hired a consultant to sample
and test the food to determine if it could be salvaged.
JUNE 10, 1992
------------------------------------------------------- Appendix I:0.2
The Minnesota Department of Agriculture agreed to accept food shipped
under Kansas's embargo to a Minnesota salvager.
JULY 13, 1992
------------------------------------------------------- Appendix I:0.3
FDA's Kansas City District Office notified KDHE that the consultant's
laboratories were on FDA's "nonacceptance" list and advised KDHE not
to accept their results. KDHE agreed to accept laboratory results
from the consultant after he told them that another laboratory had
performed the analyses.
JULY 28, 1992
------------------------------------------------------- Appendix I:0.4
KDHE began allowing food shipments to a Minnesota salvager under
KDHE's embargo after the laboratory results showed that the food was
safe for human consumption. KDHE recommended that Minnesota's
Department of Agriculture perform organoleptic (sight, smell, taste)
evaluations when the food arrived and agreed to lift the embargo upon
the Minnesota Department of Agriculture's recommendation.
AUGUST 8, 1992
------------------------------------------------------- Appendix I:0.5
The Minnesota Department of Agriculture placed a voluntary hold on a
cheese shipment and asked FDA to test the cheese. However, the
salvager sold the cheese before the laboratory results arrived.
OCTOBER 10, 1992
------------------------------------------------------- Appendix I:0.6
FDA's laboratory results showed that the cheese had contained small
amounts of chemicals, including toluene. FDA determined that the
chemical levels were not sufficient to warrant action to seize the
food.
DECEMBER 1992
------------------------------------------------------- Appendix I:0.7
The Minnesota Department of Agriculture required the Minnesota food
salvager to retest all the food from Kansas still in storage. The
retested food was judged safe for human consumption.
AUGUST 1992 TO PRESENT
------------------------------------------------------- Appendix I:0.8
No illnesses have been attributed to the food shipped to the
Minnesota salvager.
(See figure in printed edition.)Appendix II
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION
=========================================================== Appendix I
(See figure in printed edition.)
See comment 1.
(See figure in printed edition.)
See comment 2.
See comment 3.
See comment 2.
See comment 4.
(See figure in printed edition.)
See comment 5.
See comment 6.
(See figure in printed edition.)
See comment 7.
See comment 8.
See comment 9.
See comment 10.
See comment 11.
See comment 12.
(See figure in printed edition.)
See comment 13.
See comment 14.
See comment 15.
See comment 16.
See comment 17.
The following are GAO's comments on the Food and Drug
Administration's letter dated January 12, 1995.
GAO'S COMMENTS
--------------------------------------------------------- Appendix I:1
1. FDA said the primary purpose of the "nonacceptance" list is to
assist the agency's district offices in reviewing analyses submitted
to demonstrate whether products offered for import meet FDA's
requirements. FDA stated that many district offices have little
involvement in decisions about imported products and therefore have
little reason to become familiar with the list. We believe that
individuals located in district offices, regardless of whether they
are responsible for domestic or imported commodities, have reason to
become familiar with the list, particularly when advising state
agencies that may be using these same laboratories and analysts.
Furthermore, FDA's guidance was updated in June 1994 so that
laboratories and analysts who have submitted unacceptable analysis
for both domestic and imported commodities are included on the list.
Therefore, we made no changes to the report.
2. FDA's Kansas City District Office advised KDHE, on July 13, 1992,
not to accept results from the consultant's laboratories but did not
provide information about the consultant's past performance. KDHE
subsequently learned that the consultant had been under investigation
for submitting false testing data to FDA. We have changed the
chronology to show the date that KDHE was notified about the
consultant's laboratories.
3. Food was shipped to the Minnesota salvager on the basis of
laboratory results presented to KDHE, not the Minnesota Department of
Agriculture, as stated in FDA's comments.
4. Our report recognizes that no illnesses have been attributed to
consuming food from the cave fire. However, we have no evidence to
support FDA's claim that no dangerous products were consumed, nor
have we been provided with test results showing that residue levels
did not exceed levels of the same chemicals found in similar food
that had not been exposed to the fire. FDA officials told us that
they performed laboratory analysis on only two samples of food and
did not perform the sampling and testing required by FDA's own
procedures to ensure that the entire lot of food was safe for
consumption. The food was sold by the salvager before the tests were
completed.
5. GAO visited another FDA office to determine whether food
salvaging had occurred following the 1993 Midwest flood. FDA noted
that GAO found no deficiencies in FDA's activities, which, it said,
were generally similar to those following the Americold fire. We
visited an FDA office in the area affected by the flood and were
informed that no salvaging requiring the use of private food testing
laboratories was performed. Therefore, this event was not similar to
the Americold fire. We did not revise the report.
6. FDA stated that our draft report implied that FDA's Kansas City
District Office did not impress upon KDHE that the consultant was not
acceptable and notes that both FDA's district office and KDHE had
ample reason early on to question the consultant's capability. We
continue to believe that FDA did not adequately share information
about the consultant's past performance. While the district office
raised questions about the consultant's sampling and testing plan, it
provided no information to KDHE reflecting its concerns about the
consultant's past performance. This information was available
elsewhere within FDA, but was not shared with the district office
officials who were advising KDHE. In fact, KDHE officials later
learned that the consultant was the subject of an ongoing FDA
investigation. They said that had they known this earlier, they
would not have allowed food to be shipped to the Minnesota salvager.
We did not revise the report.
7. FDA contends that KDHE officials are familiar with proper
techniques for collecting and safeguarding samples. KDHE officials
agreed that this is true for samples collected by their own food
inspectors. However, they said that they rarely use private
laboratories in their routine food inspection activities and that FDA
has much more experience in dealing with private laboratories. We
have recommended in our report that following major disasters, FDA
ensure that state officials responsible for overseeing food salvaging
operations are made aware of FDA's guidance for maintaining the
integrity of the food sampling process.
8. Our report acknowledges that FDA's guidance on third-party
sampling is a recommendation, not a requirement. However, KDHE
officials said that had they known of FDA's guidance, they would have
required all food owners to hire a disinterested third party to
perform food sampling and ensure that the chain of custody over food
samples was secured.
9. We have added this sentence to the background section of our
report.
10. We agreed with this comment and removed the word "health."
11. We agreed with this comment and have revised the report.
12. According to FDA's Investigations Operations Manual, subchapter
940, paragraph 942, "Except in unusual circumstances, FDA
responsibilities are to assist the state and local health agencies in
removing, destroying or reconditioning affected merchandise. In
situations involving interstate movement of merchandise; large
interstate firms; areas in which state or local political
ramifications are anticipated; or when state or local health
officials so request; FDA may assume the primary role in the
operation." We included this statement to show that in major
disasters, FDA may take on a stronger leadership role if it chooses
to do so. We do not say, nor do we mean to imply, that KDHE was in
any way influenced by political ramifications.
13. We agreed with this comment and have revised the report.
14. We agreed with this comment and have revised the report.
15. We agreed with this comment and have revised the report.
16. We believe that the Americold fire--an event that FDA described
as "unique in that no other fire has involved such a large quantity
of food that was exposed to smoke for such a prolonged period of
time" and that resulted in the destruction of over 143 million pounds
of food--can appropriately be described as a major disaster.
Similarly, we do not question the fact that FDA supported KDHE.
However, we believe that its support could have been more effective
had it provided stronger, more proactive leadership.
17. We agreed with this comment and have revised the report.
MAJOR CONTRIBUTORS TO THIS REPORT
========================================================= Appendix III
FOOD AND AGRICULTURE ISSUE AREA
Jerilynn B. Hoy, Assistant Director
Dale A. Wolden, Project Leader
John C. Smith
Olin S. Thummel
OFFICE OF THE GENERAL COUNSEL
Alan R. Kasdan, Assistant General Counsel