Summary Report of FDA Security Surveillance Assignment from October - November 2004
Notice to Stakeholders
Notice to Stakeholders
Notice to Stakeholders:
Enclosed please find a summary report describing the activities and findings of the U.S. Food and Drug Administration (FDA) Security Surveillance Assignment, which was completed over six weeks during the months of October and November 2004.
The assignment served as a prototype for integrating food defense and food safety inspections, sample collection and laboratory testing, compliance and enforcement activities, and logistics for domestic and imported foods including Prior Notice of Imported Foods targeting.
The two major goals of this assignment were to test preparedness and promote deterrence. While it is difficult to measure the level of deterrence that this assignment afforded, there was a significant increase in food defense coverage, awareness, and preparedness achieved by the preventive activities of FDA and state inspectors at multiple and targeted points in the food distribution system and through the communication with industry. Furthermore, this assignment and the lessons learned from it have laid a foundation for integrating food defense and food safety into FDA's compliance programs. This now translates into FDA's current approach of integrating food defense into ongoing food safety assignments.
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FDA Security Surveillance Assignment
October - November 2004
November 17, 2005
Table of Contents
- Number of Inspections and Analyses
- Specific Activities of the Assignment
- Activity 1
- Activity 2
- Activity 3
- Activity 4
- Activity 5
- Activity 6
- Activity 7
- Activity 8
In 2004, the U.S. Food and Drug Administration (FDA) initiated a series of assignments associated with special security events (i.e., G8-Summit and the Democratic and Republican National Conventions) that focused on ensuring the safety and security of the nation's food supply. These special event assignments were regional and limited in scope. Based on heightened security during the national election in November 2004, FDA decided to issue a broader nationwide food defense assignment. This FDA Security Surveillance Assignment (FSSA) was designed to be national in scope, integrate food safety and defense activities, and involve Federal, state, local, and industry partners.
The FSSA commenced on October 12, 2004 and continued for six weeks. The primary goals of the FSSA were to deter intentional contamination of the food supply through heightened and targeted preventive activities at various points in the food distribution chain and to exercise the systems and networks for responding to a food related emergency during a period of increased food security risk. These systems included communications and logistics among FDA, state, and industry partners, prioritizing examination of food commodities, identification of firms handling FDA regulated products, laboratory response capabilities, import and domestic traceability of products and interfacing data, and sharing information with the intelligence community.
The activities in the assignment were conducted in cooperation and collaboration with all FDA District Offices, forty-four states, and the Commonwealth of Puerto Rico. Five different food commodities were selected for the assignment based on the highest potential for intentional contamination, as determined by vulnerability assessments previously undertaken by FDA. A total of 1,737 inspections were conducted of FDA-regulated firms, forty-nine of which were not formerly in FDA's Official Establishment Inventory (OEI). In addition, 276 samples were collected during the inspections and analyzed for multiple microbiological and chemical agents using the Food Emergency Response Network (FERN) laboratories, including FDA, U.S. Department of Agriculture (USDA), and state facilities. All sample results were negative.
The food safety component of the assignment resulted in classification of ninety-three percent of the inspections as no regulatory action indicated, six percent as voluntary actions indicated, and less than one percent of firms had official action taken by the FDA. No criteria applicable under the Bioterrorism Act of 2002, particularly the threat of a serious adverse health consequence, were found. During the inspections, FDA and state inspectors engaged each firm's management in discussion aimed at increasing food defense awareness specific to their operations, as well as provided appropriate FDA Food Security Guidance documents. Upon being asked, approximately ninety percent of the inspected establishments were willing and able to provide investigators with distribution records (i.e., one up and one down) of their suppliers or consignees.
During the assignment, FDA's Prior Notice Center (PNC), which interfaces with Customs and Border Protection (CBP) personnel and databases and other agencies (e.g., the Federal Bureau of Investigations (FBI), USDA and the Coast Guard), examined 9,058 import entries, including 14,794 entries determined to be related to the five food commodities. Screening criteria was based on commodity type, previous regulatory history, intelligence, and geographic areas of concern. Thirty-eight entries were identified as high risk resulting in directed inspection assignments by twelve different FDA District Offices across the country.
The system for responding to an increased risk of intentional contamination of the food supply was exercised through the planning and implementation of the FSSA. While it is difficult to measure the level of deterrence that this assignment afforded, there was clearly a significant increase in food defense coverage, awareness, and preparedness achieved by the preventive activities of FDA and state inspectors at multiple and targeted points in the food distribution system and through the communication with industry. Many of the gaps identified in this assignment have already been resolved by FDA, providing for a more prepared national network capable of responding to an intentional contamination.
In 2004, the U.S. Food and Drug Administration (FDA) initiated a series of assignments that were associated with special security events and focused on ensuring the safety and defense of the nation's food supply. These assignments involved activities associated with the G8-Summit, as well as the Democratic and Republican National Conventions. These special event assignments were regional and limited in scope. Based on heightened security during the national election in November 2004, FDA determined that it was appropriate to issue a broader nationwide food defense assignment. The first assignment of this nature was issued in 2003 during Operation Iraqi Freedom under Operation Liberty Shield. While, similar to the Liberty Shield assignment, this FDA Security Surveillance Assignment (FSSA) was designed to involve Federal, state, local, and industry partners to a greater extent than was done in Operation Liberty Shield and to better evaluate our national preparedness capabilities.
The primary goals of this national assignment were as follows:
- Deter intentional contamination of food through heightened and targeted preventive activities at various points in the chain of supply.
- Exercise the planning and implementation of the system for responding to a period of increased food security risk to identify and address gaps in the system.
The food items selected to be part of the assignment were based on vulnerability assessments undertaken previously by FDA. This process allowed the FSSA to focus the limited Federal, state, and local public health resources on those food commodities with the highest potential for intentional contamination.
The assignment commenced on October 12, 2004, continued for six weeks and concluded on November 19, 2004. A total of five different foods were examined during this period. The assignment was designed to integrate food safety and defense along many aspects of the food supply chain including import entry screening through prior notice, domestic and import product reconciliation examinations, domestic inspections of manufacturers and points in the distribution chain for the targeted commodities, and sample collections and analyses. Samples of the relevant food commodities were collected during the assignment. Each sample was shipped to a FERN laboratory (FDA, USDA or state) and tested for multiple analytes using FERN counterterrorism (CT) screening methods.
The planned activities of the assignment were augmented by specific instructions to District Offices based on intelligence information derived from tailored entry screening performed by the Prior Notice Center (PNC) and from activities of the District Offices and participating state counterparts.
The activities in the assignment were conducted in cooperation and collaboration with state counterparts. This was intended to enhance both FDA's and the states' preparedness to respond to the possibility of a threat involving an FDA regulated food commodity and to heighten food defense awareness. State inspectors augmented FDA's activities by identifying and inspecting unregistered firms or firms not otherwise in the FDA's Official Establishment Inventory (OEI). They also conducted targeted inspections of firms and sample collections of foods identified during the assignment through our state contracts, partnerships, cooperative programs, and other agreements. In addition, several state FERN laboratories analyzed samples. State involvement allowed FDA to test the functionality of the integrated network and reporting structures between FDA and the states.
The accomplishments from the assignment are divided into two sections. The first section provides a summary of the number of inspections undertaken and the number of samples tested during the assignment. The second, more critical section, documents the outcome from eight specific activities that were identified in the goals of the assignment.
Notably, the goals of this assignment were not aimed at a high number of inspections or sampling, but rather were aimed at utilizing the systems and networks vital to food safety and defense to respond to food-related emergencies. These systems include import and domestic traceability of products and interfacing data, identification of firms handling FDA regulated products, prioritizing examination of food commodities and sharing information with the intelligence community, laboratory response infrastructure, and communications and logistics among FDA, state, and industry networks.
Number of Inspections and Analyses
While this assignment focused on food defense, the inspections and analyses also provided the added value of the more traditional food safety component. There were a total of 1,737 inspections including those performed by FDA (1247) and the states (490). From the food safety perspective, no regulatory actions were taken in 93 percent of the inspections, voluntary actions were taken by the firm in 6 percent, and less than one percent had official action taken. With respect to food defense, our objective was limited to heightening the firms' sensitivity and awareness. In addition, no criteria applicable under the Bioterrorism Act of 2002, particularly the threat of a serious adverse health consequence, were found. All food defense preventive measures adopted by industry are voluntary.
As mentioned previously, analyses of priority agents were performed by FDA, USDA, and state FERN laboratories. A total of 276 samples were collected and analyzed. Each commodity was analyzed for multiple microbiological and chemical agents using CT methods. All sample results were negative for the agents analyzed.
Specific Activities of the Assignment
Activity 1: Enhance FDA's and our state counterpart's preparedness for the possibility of a future specified threat involving an FDA-regulated product.
All FDA District Offices, 44 states, and the Commonwealth of Puerto Rico participated in the FSSA assignment. FDA and state preparedness was significantly enhanced by the newly established or improved relationships critical to communication and coordination during periods of increased risk or a food-related emergency. For example, it was discovered during communication with one of the states that a particular commodity was not covered by a regulation if the product was sold only at retail. Based on this observation, FDA's Office of Regulatory Affairs (ORA), Division of Federal-State Relations provided information that allowed the state to promulgate a new state regulation for this product. In addition, mechanisms were developed for state inspectors to ship samples to FDA laboratories and share sample collection reports, providing an important field and laboratory link. The assignment affirmed the ability of FERN laboratories to access analytical methods and report results using a secure aspect of a web-based information laboratory network (eLEXNET). The assignment also afforded FDA an opportunity to increase awareness and training on food defense procedures, both inspectional and laboratory related.
Activity 2: Sample foods for contaminants that the Operational Risk Management (ORM) process has indicated are the most likely to be used as agents for intentionally contaminating these foods.
During the FSSA, five food commodities were analyzed for up to ten different chemical and microbiological agents, including one broad-spectrum poison screening analysis. However, not all commodities were analyzed for all agents. The selection of the food commodities and the analyses performed on each commodity was derived from FDA's vulnerability assessments. These assessments were performed using the Operational Risk Management (ORM) tool. This tool evaluates the severity of consequences should an attack on a particular food occur at a particular point in its production using a particular agent, and the probability that such an attack could occur. As such, agents, foods, and combinations thereof were prioritized for the purpose of this surveillance assignment to expend limited government resources on the highest risk foods and agents and to avoid disruption of commerce of lower risk foods. This is particularly important in a scenario in which a heightened defense environment exists, but no specific food or agent or specific food or agent threat has been identified. Such was the scenario modeled for the FSSA.
Activity 3: Augment FDA's food safety activities by identifying and inspecting unregistered firms or firms not otherwise in FDA's Official Establishment Inventory (OEI).
Forty-nine FDA-regulated firms not formerly in the OEI were added and inspected during the FSSA assignment. The inclusion of previously unregistered firms resulted in greater food safety and defense coverage and a more accurate inventory of firms under FDA's regulatory oversight. This illustrates the need for FDA to continue to examine efficient ways to ensure that the OEI is current and accurate. FDA relies heavily on information submitted by industry to maintain its OEI.
Activity 4: Exercise use of the Prior Notice Center (PNC) and intelligence gathered during field activities to identify higher risk products and target inspections, reconciliation examinations, and sample collections.
The FSSA clearly demonstrated the value of the PNC by showing its ability to target specific food commodities. During the six weeks of the assignment, the PNC examined 9,058 import entries, including 14,794 entry lines that were determined to be related to the specific food commodities chosen as part of FSSA. Screening criteria was based on commodity type, previous regulatory history, intelligence, and geographic areas of concern. The PNC interfaces with Customs and Border Protection personnel and databases as well as other agencies, including the Federal Bureau of Investigations, USDA, and the Coast Guard. This interaction enhances FDA preparedness through cooperation, collaboration, and data sharing with other Federal partners.
The PNC prioritized FSSA import entries into two categories: Priority One and Priority Two. Priority One recommendations included those entries with associated high risk elements. These elements included shipments with high import shipment targeting scores (FDA scores) indicating FDA concerns, and also took into account country of origin, related firm's registration statuses, shipment history, and law enforcement information related to the shipment firm entities. Priority Two recommendations included those entries identified with lower risk elements.
Of the FSSA import entries reviewed by the PNC, 38 entries were identified as Priority One and 9,020 were identified as Priority Two. All 38 entries identified as Priority One were deemed worthy of directed assignments to twelve different FDA District Offices across the country. The PNC directed assignments focused the efforts of the investigators and maximized the use of limited resources. These follow-up PNC directed assignments to the District Offices specified actions such as inspections, reconciliation exams, and/or sample collections. In addition to the PNC directed assignments, FDA and state inspectors conducted reconciliation examinations of products that led to potential food defense concerns and follow-up sampling or other actions.
Activity 5: Provide an opportunity for Food Emergency Response Network (FERN) laboratories to function as an integrated network in order to ensure that they can operate effectively during a food defense incident.
During the FSSA, FERN laboratories demonstrated the ability to function as an integrated network through Federal-Federal and Federal-state interactions as well as through coordinated communication and data reporting. FDA and state investigators collected samples that were shipped to eight FDA, three USDA, and four state FERN laboratories for analysis. Sample collection involved coordination between FDA inspectors, state inspectors, FERN National Program Office (NPO) personnel, as well as FDA, USDA, and state laboratory personnel. Weekly conference calls were held with the laboratories throughout the duration of the assignment to address issues related to sample receipt, sample preparation, analysis, reporting and laboratory reagent/kit inventory. FDA's Center for Food Safety and Applied Nutrition (CFSAN) and ORA personnel worked together to ensure that the most current methods were posted on the secure aspect of eLEXNET and laboratories were equipped with enough reagents and kits to perform sample analysis. Analytical data from state and USDA laboratories were reported using eLEXNET. By using eLEXNET as the data capture mechanism, all state and USDA results were consolidated into a single reporting system. This allowed FERN NPO to quickly and easily review analytical data as it was being reported instead of being required to access several different data reporting systems.
Activity 6: Exercise communication and reporting structures throughout FDA [Office of Regulatory Affairs (ORA), Office of Crisis Management (OCM), and the Center for Food Safety and Applied Nutrition (CFSAN)], as well as communication and collaboration with the states, Customs and Border Protection (CBP), and the FERN labs.
There were many opportunities to test and evaluate the communication and reporting channels during the development and implementation of the FSSA. Prior to the FSSA, FDA initiated a series of calls with the food industry and states, as well as with the FDA Field staff to explain the nature of the assignment and to answer any questions. With respect to the PNC import entry screening, daily calls were held by a core ORA/CFSAN implementation team to assess information and decide what additional assignments should be directed to the field. Overall, the interaction and communications with Federal, state, local, and industry partners enhanced our working relationships in many areas and fostered cooperation for future food defense initiatives with open communication and a clearer understanding of the reporting channels. This reinforced the need for good communication with stakeholders prior to and during such assignments.
Reporting structures were also tested and evaluated during the implementation of the FSSA. During the assignment, a few screening samples were found to be presumptively positive. After further confirmatory analysis, these samples were determined not to be of concern. However, the presence of the presumptive positive samples allowed testing of the communication channels within FDA designed to assess the implications of a presumptive positive sample and the consideration of appropriate action if confirmed.
Activity 7: Heighten food defense awareness on the part of specified industry segments considered to be vulnerable to intentional contamination as well as FDA, our state counterparts, and industry.
Prior to the assignment, CFSAN and ORA held briefings with the affected industry trade associations. These briefings increased awareness of FDA food defense activities, in particular the ORM process applicable to each industry. Discussions with industry associations continued during and after the assignment to address additional questions and concerns.
During the assignment, each of the 1737 FDA-regulated firms inspected was provided with a copy of the appropriate FDA Food Defense Guidance documents. In addition to providing this written information, FDA engaged each firm's management in dialogue aimed at increasing food defense awareness specific to their operations. This exchange also afforded the firm an opportunity to identify and enhance preventive measures to increase food defense. In addition, approximately 90 percent of the establishments were willing and able to provide FDA investigators with distribution records (i.e., one up and one down) of their suppliers or consignees. Overall, the assignment served to increase industry awareness, as well as to heighten FDA and state awareness during the period of increased risk.
Activity 8: Identify gaps in the system for responding to a period of increased food defense risk so that they may be addressed to enhance preparedness.
Prior to, during, and at the conclusion of the assignment, there was a concerted effort to consult with the various parties involved at the Federal, state, and industry levels to identify gaps in the system and areas for improvement. The outcome of this effort resulted in several areas in which future activities will be focused to enhance preparedness relative to FDA's Federal, state, local, and industry partners.
Areas of improvement identified from feedback on the assignment include:
- Fully integrate food defense as a routine and dedicated activity alongside food safety.
- Establish rapid emergency processes and procedures for multiple operations.
- Enhance communication and coordination with states, other Federal agencies, and industry to increase preparedness for food defense.
Since the completion of the assignment, FDA has made significant progress in many of these areas. Some examples include incorporating the provision of food defense procedures into routine FDA inspections and reference documents, developing and providing food defense training at Federal, state, and local levels, and providing funding in state contracts for sample collection. Another improvement made as a result of the development and implementation of the assignment is the increased laboratory infrastructure for non-traditional agents and methods development.
Overall, there was good support for this assignment. However, there were issues with resources at both the Federal and state levels. The FSSA competed with established work plans in which personnel, equipment, and other resources were primarily dedicated for other activities. To date, FDA has taken steps to address some of these issues by modifying state contracts to allow for collection and payment of samples, including funding for training and sample costs and designating time for food defense efforts in the FDA work plan. Continued integration of food defense and food safety will allow maximum value from current resources.
The identified goals, activities, and objectives of the FSSA were accomplished. While it is difficult to measure the level of deterrence of intentional contamination that this assignment afforded during this period of increased risk, there was clearly a significant increase in food defense awareness achieved by preventive activities of FDA Investigators and state inspectors at multiple and targeted points in the food distribution system and through the communications with industry, both individual firms as well as trade associations. The system for responding to an increased food defense risk of intentional contamination was exercised through planning and implementation of the assignment, resulting in identification of gaps in the system.
Many of the gaps identified in this assignment have been resolved and FDA is better prepared to respond to an intentional food contamination event. The communication and coordination accomplishments alone provide for a more prepared national network capable of responding to an intentional event. Despite the success of the FSSA, FDA will continue to identify ways to further increase the levels of preparedness for a deliberate attack on the food supply. Of particular importance in this regard is continued close interaction with FDA stakeholders including Federal, state, local, and industry partners.
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