Assessment of FDA Rapid Response Team’s Implementation
Brenda D. Morris
Environmental Administrator
Florida Department of Agriculture and Consumer Services, Division of Food Safety
International Food Protection Training Institute (IFPTI)
2011 Fellow in Applied Science, Law, and Policy: Fellowship in Food Protection
Abstract
The promulgation of federal initiatives and directives after the September 11, 2001, terrorists’ attacks on the United States provided resources to various federal agencies to improve our nation’s response to and preparedness for emergencies. In 2008, the U.S. Food and Drug Administration (FDA) announced the Food Protection Rapid Response Team (RRT) and Program Infrastructure Improvement Prototype Project (U18), which provided significant funding for nine pilot states to develop and identify components that would strengthen and implement a rapid response to food- and feed- related emergencies (U.S. Food and Drug Administration RFA FD08 007, 2008). The three- to five-year FDA cooperative agreement provided milestones and expected accomplishments that would require documentation and reporting to substantiate progress, regulatory compliance, and corrective action supporting the FDA project. The compiled information would be used to corroborate continued and sustainable funding necessary for the success and continued implementation of the FDA program. States need assurance of continued sustainable funding from the federal government to provide for long-term planning and continued development of a feed/food emergency response plan to assure a safe food supply for the nation. Such funding would also allow for the pilot states’ completion of the RRT Best Practices Manual to be used by other states or entities that want to develop a rapid response to food/feed incidences. This research study was designed to evaluate the progress made by states on the deliverables of the cooperative agreement. The results demonstrate achievements as well as challenges of implementing and sustaining a Rapid Response Team.
Background
The attacks of September 11, 2001, forever changed the United States. The reality of an intentional attack on the nation’s food supply became an immediate national security concern and priority. The federal government began evaluating the vulnerability of the U.S. food and feed supply and enacted the Bioterrorism Act of 2002 (U.S. Department of Health and Human Services, 2002). The Homeland Security Presidential Directive empowered the federal government to fund and develop programs to protect the nation’s food supply (U.S. Food and Drug Administration RFA-FD 08-007, 2008). In 2008, the Office of Regulatory Affairs (ORA) introduced a program through the FDA Division of Federal-State Relations (DFSR) to provide guidance to help states identify and implement means to strengthen food safety programs and develop a rapid response to food- and feed-related incidents. The project became known as the Rapid Response Team (RRT). Initially, the project funded six states (California, Florida, Massachusetts, Michigan, Minnesota, and North Carolina) to participate in the pilot program, and in 2009, selected three additional states (Texas, Virginia, and Washington) to participate. The nine states selected had evidence of an existing or a potential response plan. The pilot states’ representatives submitted documentation of their infrastructure and response capabilities to the Western Institute for Food Safety and Security (WIFSS) through an onsite face-to-face meeting. WIFSS developed a written assessment of the states’ current preparedness using the documentation provided. The states would were required to develop their programs based on their individual state government structures, existing emergency response plans, and the numbers and types of food emergencies that have occurred in the past. The RRT pilot program, funded for three to five years, required states to plan and document how to improve, strengthen, and integrate the program components into their state plans. The initial deliverables of the pilot program included:
· conduct exercises emulating intentional food contamination and prepare an After Action Report (AAR) that provided an overview of strengths and weaknesses of the teams’ performance during the emergency;
· implement an Incident Command System (ICS);
· develop and foster multi-agency relationships;
· implement Manufactured Food Regulatory Program Standards (MFRPS) as enacted by the Food Safety Modernization Act (FSMA);
· develop and specialize in rapid response capabilities;
· conduct annual self-assessments;
· provide an MFRPS Program Assessment Validation Audit;
· participate in the development of an RRT Playbook; and
· send state officials to annual face-to-face meetings with FDA officials.
Problem Statement
Since the inception of the RRT pilot program in 2008, states have worked to develop and implement the components required in the cooperative agreement. States have been allowed to define and structure their RRT based on their unique structure, organization, needs, and assets. Because of the diversity of each state program, comparing specific details and assessing progress equally is difficult. Pilot RRTs may not have an understanding of the collective unforeseen challenges and achievements resulting from implementation, as well as the advancements that have been accomplished throughout the pilot project.
Research Questions
To evaluate the progress of the states’ implementation of the RRT cooperative agreement, this study was designed to answer the following research questions:
1. What progress has been made by the pilot RRT programs since the original WIFSS assessment?
2. What are the challenges of the state RRT programs?
3. What are the achievements resulting from implementing the RRT programs?
Methodology
The research data for this project were collected in two ways. First, all of the nine pilot state RRT project managers were asked to submit a copy of their WIFSS assessment, which provided baseline data for each state. The contract with the WIFSS included assessment of the response plan, identification of training needs, evaluation of the level of preparedness, and interaction among agencies. The information gathered at the inception of the RRT pilot project was used to design and implement the RRT program.
The second component of this research study involved phone interviews with the designated RRT program manager in each of the nine states. Eleven questions were developed based on discussions with subject matter experts, methodologists, and experts in the DFSR. Some of the information gathered was charted to show the progress and completion of components of the grant.
Results
All nine RRT pilot states participated in this research study and supplied answers to the interview questions, which provided details of their progress. These interviews revealed that all nine states have designed and initiated the implementation of a written program to meet the requirements of the Food Protection RRT and Program Infrastructure Improvement Prototype Project (U18).
Seven states held at least one concept exercise since inception. However, as illustrated in Figure 1, in 2010 and 2011, only two of the nine states (22%) met the requirement of holding an annual concept exercise. Four states (44%) completed AARs from annual concept exercises, which identified corrective actions needed to improve multi-agency performance. Seven states’ RRTs (78%) met quarterly with the FDA and other core partners, either via conference call or in face-to-face meetings, to foster communication, build relationships, better define and reevaluate roles and responsibilities, and maintain infrastructure of the team. Eight states (89%) indicated they implemented an ICS to provide an effective framework of communication and coordination if an actual emergency occurred. Nine states (100%) reported that faster and more effective communication was developed and fostered between all RRT agencies and the FDA.
The project managers were asked to identify the top two challenges facing their RRT. Figure 2 shows that lack of adequate and sustainable funding was the major challenge and lack of manpower to perform both the core mission of their department and to incorporate necessary training and exercises was the second challenge.
The last question asked the project managers to identify the top two achievements resulting from the implementation of an RRT. As seen in Figure 3, seven states saw an increase in speed and transparency in responding and in implementing control measures resulting from an incident, and the movement to response mode from reaction mode improved considerably. Six states indicated that the working relationships developed through the RRT program had greatly impacted their ability to respond faster, communicate more clearly, and coordinate action faster during exercises and actual events requiring coordination of efforts.
Conclusions
The findings of this research demonstrate the dedication and commitment of the RRT pilot states. States have made significant progress in training and development for preparedness and investigations. Without sustainable funding, states will be unable to continue planning, developing, and implementing the necessary components of an effective integrated food safety system. States will continue to be cautious and guarded with financial resources and responsibilities without the assuredness that funds will be available to expand and advance the project. States have primarily focused on required deliverables as their program priorities and have viewed recommendations for the project as secondary objectives. As a result, key objectives of the RRT pilot program, such as annual exercises, were delayed as states prioritized requirements based on deliverables rather than focusing on the project as a whole. The diverse frameworks within states have presented challenges in developing a model plan to execute, but states have collaborated to overcome these issues. This work has significantly benefited the agencies and their food and feed programs that would serve as key participants in the event of an emergency. Written plans and strategies have increased, resulting in improved readiness and the ability to respond quickly. States can continue to strengthen their RRT through trial and error with real-world food emergencies and AARs. Protocols and procedures are now the norm in the chain of events that will occur at the report of a possible emergency. Additional components of the RRT pilot program not evaluated in this research were discussed during the interview and further demonstrate that states are taking remarkable steps to implement RRT program requirements.
Recommendations
States need assurance of sustainable funding from the federal government to provide for long-term planning and development of an RRT. Included in the RRT program are multiple layers of requirements and components for national programs leading towards the objectives of FSMA, including the MFRPS. The need for a nationwide, integrated food and feed emergency response plan is critical—now more than ever—for the security of the United States. Failure to allocate and continue funding would be a tremendous setback in the strides taken by the government to protect the food supply. Funding is also crucial for both the designated state program manager and RRT coordinator, who should focus primarily on the development and advancement of the states’ food safety emergency response team. People involved in overseeing the core mission of their state’s food safety organization and managing the RRT are challenged to provide the direction and oversight needed for a successful program.
All program components expected of states should be required deliverables, rather than recommendations. When milestones are expected, but not required as an annual milestone, they become secondary in importance. Many program recommendations are key to completing effective deliverables. Additional face-to-face meetings with the auditors regarding self-assessments to stay on track with the deliverables would be beneficial.
Actual RRT food emergencies should count as training events when an AAR is conducted and reviewed with the team. States are already involved in actual incidents of varying degrees and have constraints regarding manpower. This approach would allow for a more thorough review of the incidences in order to discuss possible challenges and issues. These actual emergencies, the lessons learned, and the AARs could be used as learning tools for other states.
The project manager should plan and schedule quarterly meetings one year in advance and require a minimum of one face-to-face meeting per year. This advance scheduling would allow direct interaction with those people who are key players in the RRT program agencies. More frequent and scheduled assessment reviews would allow states to continue to stay focused and on track to implement the goals and objectives of the program.
The continued development of an RRT Best Practices Manual (previously known as the RRT Playbook) is the foundation of a model program. Adding a chapter titled “Getting Started: The Basics,” in which to share groundwork laid and initial lessons learned, would benefit other states wanting to develop a rapid response plan to food and feed emergencies. This additional chapter would increase efficiency during the development stages and would help states avoid challenges initially experienced by the pilot program states.
Acknowledgements
I would like to express my gratitude to the International Food Protection Training Institute (IFPTI) instructors and staff for this invaluable experience. I would like to thank my mentor, Jim Sevchik, for his guidance, encouragement, and friendship during this Fellowship. I am forever grateful for the support and encouragement of Dr. John Fruin, Lee Cornman, and Dr. Marion Aller of the Florida Department of Agriculture and Consumer Services for the opportunity to participate in this educational experience. The friendships developed with my cohort members will be long remembered and cherished.
Corresponding Author
Brenda Morris, Florida Department of Agriculture and Consumer Services, Division of Food Safety
Email: Brenda.Morris@freshfromflorida.com
References
U.S. Department of Health and Human Services. (2002). Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL107-188), Letter from Center Director. Retrieved from http://www.fda.gov/food/fooddefense/bioterrorism/ucm111086.htm#attach-a
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