Special Event Food Defense Assignment (SEFDA) Report - September 2008

Executive Summary

The Special Event Food Defense Assignment (SEFDA) is the latest food defense related Food and Drug Administration (FDA) field activity. The SEFDA was designed as a proactive effort to prepare for the protection of food that would be served during the Republican and Democratic National Conventions as well as to develop a template for future special security events. It was planned and conducted jointly with several FDA operational divisions (Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulatory Affairs (ORA)), as well as the Food Emergency Response Network (FERN) Laboratories and state and local regulatory agencies in Minnesota and Colorado, the sites for the 2008 National Political Conventions. SEFDA activities began on May 5, 2008 and continued until May 23, 2008. The assignment focused on nearby retail and food service establishments, and food distributors whose products would likely be consumed by convention participants.

The over-arching goals of this assignment were to:

Exercise the planning and implementation of a coordinated approach for food protection during high-profile special events among Federal, State and Local agency partners.
Examine the traceability of higher risk foods served at special events.
Create a template assignment for food safety and defense activities that can be used for other special events.

During the SEFDA, regulatory participants were tasked with conducting records examinations and inspections as well as collecting and analyzing food samples. Throughout the duration of the assignment, 129 inspections were made in the convention cities and nearby areas and 364 samples were analyzed. All samples analyzed were negative.

Background

In August and September of 2008, the Democratic and Republican National Conventions were occurring. In preparation for response to those events, the Food and Drug Administration (FDA) wanted to take a proactive approach in planning and collaboration with its Federal, State and Local counterparts. The Special Event Food Defense Assignment (SEFDA) sought to achieve this while creating a template for future food protection activities involving heightened security.

Scope

This Special Event Food Safety and Food Defense Assignment (SEFDA) allowed for multiple Federal, State, and Local firms to exercise the planning and implementation of a coordinated approach for food protection during high-profile special events. It focused on examining the traceability of higher risked foods served at special events, sampling and analyzing an increased number commodities and creating a template for future use. While no specific threat information has been received, the following foods were selected for sampling and trace back during this assignment: milk, bottled water, soda, juice, lettuce, and muffins. Over the course of SEFDA (May 5-23, 2008), participants were asked to:

Conduct routine food safety inspections of the firms
Disseminate and discuss ALERT information
Complete and submit trace back information
Collect a sample and send to Food Emergency Response Network (FERN) lab

The SEFDA provided an opportunity to practice coordination, and communication among regulatory agencies that will be involved in food protection activities during the 2008 National Political Conventions. It also helped to form the basis for future assignments related to special event food protection. The following outlines the specific goals set forth in the assignment along with specifics on how each was achieved.

Goal 1:

Enhance preparedness in specific industry segments and among FDA and State and Local counterparts.

Accomplishment:

This assignment incorporated several jurisdictions including Local, State and Federal partners: the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Regulatory Affairs (ORA), the Department of Defense (DoD): Veterinary Service Activity and U.S. Army Veterinary Command, Denver City/County Health Department, Colorado Department of Health and Environment, Minnesota Department of Health, Minnesota Department of Agriculture, City of Bloomington, MN, City of Minneapolis: Environmental Health, City of St. Paul: Department of Safety & Inspections and the FERN Labs at the following locations: University of Iowa Hygienic Laboratory, Wisconsin State Laboratory of Hygiene, FDA Denver District Laboratory, Minnesota Department of Agriculture, Michigan Department of Community Health and FDA WEAC. All participating inspectors were tasked with discussing the FDA's ALERT initiative with their respective regulated industries. Inspectors from State and Local regulatory agencies were asked to conduct a food safety inspection within their regulated industry and discuss food defense awareness and preparedness. Inspectors collected samples of targeted food commodities and sent them to be analyzed to previously identified FERN Laboratories. This assignment served as a trial run for enhancing preparedness of Food Safety/Food Defense during the Democratic National Convention (DNC) and Republican National Convention (RNC), both to be held this fall. Federal, State and Local inspectors focused their activities on those food industry segments that would be servicing both the DNC and RNC.

Goal 2:

Demonstrate a coordinated system for responding to events requiring special security procedures and demonstrate targeted preventive activities at various points in the food supply chain.

Accomplishment:

The activities performed during this assignment helped to build a template that can be used for future special event activities. As part of this assignment, participants were able to display a coordinated effort in their Food Safety/Food Defense activities. The FDA regional food specialists were used as a communication link between state and local agencies with the federal agencies. This assignment assisted the state and local agencies by providing a better understanding of the proper procedures used when collecting trace back information, and sampling and shipping food samples. Trace back information obtained from retail and food service establishments was shared with FDA District investigators. Investigators then linked this information with distributors under FDA jurisdiction, allowing for a more detailed inspectional history of the food supply chain. Collection and shipping of food samples is not part of the normal routing for several local regulatory agencies. Appropriate sampling and shipping procedures are beneficial to know and be familiar with in the event of an intentional contamination. The table below states the number of inspections and samples collected from each agency within the timeframe of the assignment.

Agency	# of Inspections	# of Samples
City of Bloomington	16	31
City of Minneapolis	16	31
City of St. Paul	22	84
Minnesota Department of Agriculture	5	12
Denver Environmental Health	21	77
FDA Minnesota District Office	19	34
FDA Denver District Office	30	97
TOTALS	129	364

Goal 3:

Exercise the integration of food safety and food defense activities using existing infrastructure at the Federal, State and Local levels.

Accomplishment:

The assignment tasked inspectors with jointly conducting both routine inspections and SEFDA related activities at each food facility. By incorporating food defense related messages into routine regulatory activities participants were able to reduce resource expenditure.

Goal 4:

Exercise FERN laboratory analytical surge capabilities and network communication procedures, including expedited data entry and reporting procedures.

Accomplishment:

SEFDA ensured that the six participating FERN labs had the capacity to receive and analyze an increased number of samples. Analysis included testing for chemistry, microbiological and radio nucleotide agents (7 total analytes). All samples analyzed were negative. The participating labs received a large volume of samples compared to their usual sample load, which would be typical in case of an emergency. Through this, we were able to test the surge capacity of each of the participating labs. The use of the FERN increased the number of samples that could be analyzed in a timely manner. 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.

Goal 5:

Conduct a training activity to improve communication and collaboration with the U.S. Department of Defense (DoD).

Accomplishment:

As part of the SEFDA, food inspectors from the U.S. Department of Defense participated in FDA led inspections. This allowed the DoD inspectors an opportunity for them to compare notes on how the FDA conducts their food inspections as well as an opportunity for sharing of ideas for future collaboration.

Goal 6:

Identify gaps in the system for responding to events requiring special security procedures and address the gaps to ensure seamless integration of food defense activities across Federal, State and Local agencies and to enhance preparedness.

Accomplishment:

Based on a meeting held at the conclusion of the SEFDA (hotwash), all participants stated that this was a worthwhile effort and that valuable information was gained. However, some areas for improvement were noted. The categories are; education, information collection/submittal, and infrastructure.

Education:

After the assignment, some participants stated that there was a need for clarification on what roles they were supposed to have played. Some agencies noted that it was not clear who their point of contact was, which made the work difficult to complete.

A few participants noted that there was some confusion when it came to the collection and shipment of samples. Participants stated that a bit more information as to what ALERT information needed to be disseminated would have been helpful. Participants requested that for future assignments a one page summary, as to what information should be discussed, should be attached for easy access. Participants mentioned that more practice is needed and with this these tasks should become easier to complete. An appendix on ALERT was included in the assignment for easy reference. Additional training and reference material will be included in future assignments.

Information Standardization/collection:

A common traceback form was offered to be used during the assignment, though it was noted that there were some software limitations at different agencies that prevented its use. It was suggested that this form be reworked in a format that would be accessible to all and that sample collection information should also be standardized in an effort to make data collection easier and more uniform.

Infrastructure:

Participants noted that any forms to be used for future activities should be developed in a format that would be accessible to all. While planning for the assignment, it was noted that there were certain agencies for which sample collection and shipment was not part of their normal routine. As such, they did not have the equipment needed to ship samples to labs to which they normally would not ship to. Though FDA was quick to supply the equipment needed, it was noted that in order to enhance their preparedness, those agencies should consider stocking supplies that would be needed in case of an emergency. FDA will continue to explore short term and long term solution to the equipment needs of state and local regulatory agencies.