Table of Contents
The Food Defense Surveillance Assignment (FDSA) is the latest in a progressively more complex series of food defense related field activities. The FDSA is the first food defense field assignment that engaged several federal, state and local organization representatives in all aspects of the planning, implementation and evaluation of this activity. The activity was designed to test communication and coordination between regulatory agencies when examining a dual jurisdictional commodity. It was conducted jointly with several FDA and USDA operational divisions, as well as many state and local regulatory agencies as well as the Food Emergency Response Network (FERN) Laboratories. The assignment scenario was designed around a finished product that is regulated by both the FDA and the USDA and is commonly used in the National School Lunch Program as well as state/local regulated retail and foodservice establishments. Inspectors from all of the participating agencies were asked to raise food defense awareness by sharing the ALERT message or similar food defense messaging which addresses preventative measures that can be taken to reduce risk of intentional food contamination. FDSA inspections began March 5, 2007 and continued for four weeks through March 30, 2007. The primary goals of the FDSA were:
- Heighten food defense awareness in specific industry segments as well as the FDA and USDA field staff and the State and local counterparts; and
- Enhance preparedness by FDA, USDA and the State and local counterparts for a possible threat involving a dual jurisdictional regulated food product.
The scope covered the supply chain from farms to distributing firms and manufacturers to retail stores and restaurants and school district central kitchens. During the inspections, FDA, USDA, state, and local inspectors conducted a food safety inspection and engaged each firm's management in discussion aimed at increasing food defense awareness specific to their operations. Investigators also collected records and, in some cases, a physical sample.
The assignment was coordinated through the Joint Coordination Team (JCT) made up of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Regulatory Affairs (ORA), USDA's Food Safety and Inspection Service (FSIS), Agricultural Marketing Service (AMS), and Food and Nutrition Service (FNS). The JCT received and reviewed records from the field and selected the locations for the following week's tasks. Weekly conference calls and frequent emails with all participants disseminated relevant FDSA information.
A total of 405 inspections were conducted by FDA District Offices, FSIS, AMS and 43 states including local jurisdictions. Inspectors collected physical samples including pasta sauce with or without meat and three key ingredients; tomatoes, beef, and spices. A total of 123 samples were collected and analyzed for potential microbiological and chemical agents of concern. Laboratory analysis was completed by 23 members of the Food Emergency Response Network (FERN). All sample analyses were negative.
While measurement of deterrence is subjective, this assignment enhanced food defense awareness and preparedness. FDA, USDA, state and local inspectors demonstrated an ability to trace product back from retail to the manufacturing facility approximately sixty five percent of the time. In some cases records were not available from industry or the investigators failed to collect the proper information. Overall, planning and coordination efforts were successful although there are opportunities to streamline the process. The FDSA demonstrated the ability and willingness of all participants to communicate coordinate and collaborate to achieve a uniform response to a potential credible threat to the food supply.
In 2004, the FDA conducted a nationwide assignment, the Food Security Surveillance Assignment (FSSA), to evaluate stakeholder communication and identify gaps in response to a time of increased risk of intentional contamination to our nation's food supply. Since the completion of the FSSA, the FDA and its counterparts have worked to resolve some of the gaps identified. In 2007, the FDSA sought to evaluate the progress made, expand the participation and improve cooperation between FDA and its counterparts.
The FDSA provided an opportunity for multiple Federal, state and local regulators to work together to exercise systems related to preparedness and response to a credible food and agriculture sector related threat. It focused on pasta sauce with or without meat and three key ingredients; tomatoes, beef, and spices which represent commodities regulated by either FDA or USDA. The FDSA instructed regulators to visit school central kitchens, foodservice and retail establishments, and warehouses in addition to food processors where these commodities are commonly stocked. When visiting these facilities, participants were asked to:
- Conduct routine food safety inspections
- Disseminate and discuss ALERT information
- Collect and submit trace back/trace forward information for the commodities of interest
- Collect a sample of the finished product and send to a participating FERN lab for analysis
The FDSA provided an opportunity to coordinate communication and reporting among the regulatory agencies and laboratories nationwide. The resources and activities helped assess the state of readiness to respond to threats involving multiple jurisdictions as well as initiate and/or maintain food defense awareness among industry groups.
FDA led in the construction of this assignment as a means to encourage interagency collaboration and communication. The FDA,, US Department of Agriculture (USDA) and participants from national, state and local organizations, including Association of Animal Feed Control Officials (AFCO), Association of Food and Drug Officials (AFDO), Association of Public Health Laboratories (APHL), Association of State and Territorial Health Officials (ASTHO), National Association of City and County Health Officials (NACCHO), National Association of Local Boards of Health (NALBOH), National Association of State Departments of Agriculture (NASDA), National Environmental Health Association (NEHA), and United Stated Animal Health Association (USAHA) participated in the planning. The USDA Food and Nutrition Service (FNS) worked as a liaison with their program operators of the National School Lunch Program while the FDA's Office of Regulatory Affairs (ORA) served as the liaison to the state and local organizations. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) served as the chair for JCT which also contained members of the planning organizations mentioned previously.
Inspection participants included ORA along with the USDA's Food Safety and Inspection Service (FSIS) Inspectors, the Agricultural Marketing Service (AMS) Fruit and Vegetable Programs and volunteer State and local regulators who inspected firms within their jurisdictions. Some state agencies under contractual agreement with the FDA were also utilized during the FDSA. State and local FERN laboratories, ORA, FSIS and an AMS FERN laboratory also participated in sample analysis potion of the assignment.
Goals & Accomplishments
Heighten food defense awareness in specific industry segments as well as the FDA and USDA field staff and the state and local counterparts;
Food defense awareness in the industry sector was raised due to discussion of the ALERT initiative. The ALERT initiative lists five primary points of consideration in relation to food defense and is designed to spark thought and communication between industry and regulators. More federal, state and local participants disseminated food defense messages than in any other food defense assignment. Forty-three states and many local agencies were represented. We also had an opportunity to engage over 400 food facilities including over 200 retail/food service facilities, and eight school district central kitchens which were portions of the food supply chain not covered in prior assignments.
Enhance preparedness by FDA, USDA and the state and local counterparts for a possible threat involving a dual jurisdictional regulated food product;
Pasta sauce with or without meat and key ingredients are used in the National School Lunch Program and retail/foodservice facilities. At various points in the supply chain the product may be primarily controlled by FDA, FSIS, AMS (for quality), and the state and local regulatory agencies. Inspectors from ORA, FSIS, AMS and state (both contract and volunteer) and local agencies were tasked in a manner which allowed for the maximum number of facilities to be inspected.
Display a coordinated system to demonstrate targeted preventive activities at various points in the food supply chain;
While FDA has completed several other food defense field assignments, the FDSA is the first with multiple agency participation in all phases of planning and implementation. The planning phase began months in advance with 2 federal organizations, and 9 state and local organization partners collaborating to create the FDSA framework. The assignment allowed participants to display the ability to focus on a commodity from farm to table, across multiple jurisdictions.
Integrate food safety and food defense activities by exercising existing infrastructure at the federal, state and local levels;
The assignment tasked inspectors to conduct both routine food safety inspections and FDSA related activities at each food facility. By incorporating food defense related messages into routine food safety regulatory activities participants were able to reduce resource expenditure.
Augment food safety and food defense (security) activities by identifying and inspecting food processing plants registered and unregistered in accordance with the Bioterrorism (BT) Act of 2002;
Inspectors that confirm BT Act registration status as part of the routine inspection procedure did so during the course of the FDSA. It is noted that not all firms selected for inspection are required to register. Furthermore, not all inspectors have access which would allow them to determine the registration status of firms.
Utilize Food Emergency Response Network (FERN) laboratories to function as an integrated network in order to ensure that they can operate effectively during a food risk incident;
FDSA ensured that the 23 participating FERN labs had the capacity to receive and analyze for chemical and microbiological agents of concern. The use of the FERN increased the number of samples that could be analyzed in a timely manner. FDA was able to evaluate the role of these labs in the event of a food defense emergency. Shipping and receiving procedures that might be used in times of food emergencies were evaluated. Samples were shipped and received outside of the routine channels.
Exercise communication, collaboration and reporting structures throughout and among FDA, USDA, our state and local counterparts, and FERN laboratories;
The FDSA afforded participants the opportunity to coordinate activities amongst themselves as well as with other partners. Overall, assignment activities were coordinated by the JCT, with members of all federal organizations. The JCT was able to determine what inspections needed to be conducted and was able to assign them in an efficient manner. The JCT was a central point for collection, review and dissemination of information. Inspectors were tasked with collecting trace back/forward information and then submitting this to the JCT. The JCT reviewed submittals and directed inspections based on this information. The FDSA demonstrated the capacity to trace finished product from retail to distribution to manufacture.
Sample foods for microbial and chemical contaminants that risk assessments have indicated are the most likely to be used as agents for intentionally contaminating these foods, exposing the FERN labs to an expanded list of food/agent combinations;
123 different samples of tomato sauces and its ingredients were taken. Samples were sent to FDA, USDA, FERN laboratories for microbial and chemical analysis. All results were negative.
Identify gaps in the system for responding during a period of increased food risk so that they may be addressed to ensure seamless integration of food defense activities across Federal, State and local agencies and to enhance preparedness in the future.
Based on an evaluation conducted at the conclusion of the FDSA, 90% of the participants clearly understood their role within the assignment. The overwhelming majority stated that they would be willing to participate again in a similar endeavor. However, some areas for improvement were noted. The categories are; planning, information collection/submittal and communication.
While some state and local organizations were active participants, others were not as engaged. There is an opportunity for further collaboration with new interested partners. It is also recognized that no scenario can engage all facets of federal, state and local stakeholders; future endeavors may offer opportunities to incorporate other partners such as, private industry, animal health and law enforcement agencies.
Inspectors were asked to collect and submit trace back/forward information pertaining to the products of interest. The FDSA did not offer a standardized method for collection, and only 49% of participants stated that they had a mechanism in place to collect this information. This required the majority of participating agencies to develop a way to capture the data. The differences in format and content led to challenges for the JCT review process as well. A standardized method of collection would be helpful. Also, offering training to assist inspectors in identifying all pertinent manufacturing, distribution and retail identifiers would be useful.
The information requested was not always readily available from industry. It was reported that only 42% of firms inspected were able to provide all records requested. In general, products could be traced from firm to firm but not by product lot. It was also noted that different information was used to track products at various points in the food supply chain. Additional education about the value of record keeping and a refined summary of information necessary to track products is important.
Out of date records also proved to be a challenge. In approximately 5% of directed inspections, the firm could not be located from the data obtained from a previous inspection. Keeping current points of contact available is essential in the trace back/forward process.
Overall 75% of participants felt that the weekly announcements and other interactions with the JCT were adequate. However, it was pointed out by participants that the assignment contained a few ambiguous phases that created confusion in segments of the regulatory community. For example, the use of the word "serve", in the Implementation section, led participants to believe that retail facilities that solely "sold" the product of interest were not targeted as part of the assignment. Care must be taken to eliminate imprecise language. Additionally, strides were made to open communication lines between participants. For example, links between the FERN and inspectors improved over the course of the assignment.
While measurement of deterrence is subjective, this assignment enhanced food defense awareness and preparedness. Approximately 59% of firms were receptive to the ALERT message and 55% of inspectors planned to continue to share food defense messages. Overall, planning and coordination efforts were successful and there are identified opportunities to further streamline the process. The FDSA displayed the participants' capacity and enthusiasm to work together toward a common goal in an effort to secure the food supply. Based on comments and the evaluation, participants appear motivated to join in future food defense activities.