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. 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; (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. 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. 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. 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. 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. 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 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 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. 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. 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. 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. 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. 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 will also make copies available to others upon request. 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. 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. The Minnesota Department of Agriculture agreed to accept food shipped under Kansas's embargo to a Minnesota salvager. 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. 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. 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. 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. 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. No illnesses have been attributed to the food shipped to the Minnesota salvager. The following are GAO's comments on the Food and Drug Administration's letter dated January 12, 1995. 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. Alan R. 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Summary:
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.