Improving FDA's Efforts to Achieve an Integrated Food Safety System and Implement FSMA
September 9, 2011
Michael R. Taylor, Deputy Commissioner for Foods
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy
Dara Corrigan, Associate Commissioner for Regulatory Affairs
Next Steps to Full Partnership
Building an integrated national food safety system has long been a foundational element of FDA’s strategy for carrying out an effective and efficient food safety program. It is also one of the key mandates of the new FDA Food Safety Modernization Act (FSMA). Such a system is premised on building full strategic and operational partnerships with state and local food safety agencies – an effort in which FDA has been engaged for the last decade through the Partnership for Food Protection and other initiatives.
FDA now faces several imperatives to take this effort to a higher level, including: (1) FSMA’s several mandates to work in full partnership with the states, (2) calls by state and local officials to strengthen the partnership and transform it to operate more seamlessly in an atmosphere of mutual reliance and respect, and (3) the budget-driven imperative to make the most efficient possible use of all available food safety resources.
For all these reasons and as outlined below, FDA is taking several steps to elevate the leadership and management focus on federal-state integration and to further develop its strategies and plans for achieving full partnership and fulfilling the vision of an integrated national food safety system.
Elevating Leadership and Management
- Organizational Changes: The Office of Regulatory Affairs (ORA) has initiated the process of creating an Office of Partnerships and moving its Division of Federal-State Relations to that new office. This organizational change will ensure that the need to work with state and local officials and other critical partners is fully recognized and addressed by ORA.
- Senior Advisor for Federal-State Relations: In addition, ORA is creating the new position of Senior Advisor for Federal-State Relations, which will report to the Associate Commissioner for Regulatory Affairs (ACRA). The Senior Advisor for Federal-State Relations will be Joe Reardon, who will work with the ACRA to provide the leadership and strategic direction necessary for achieving a national integrated food safety system.
- Director of Intergovernmental Affairs and Partnerships: The Office of Foods is creating the new senior position of Director of Intergovernmental Affairs and Partnerships, reporting to the Deputy Commissioner for Foods, with a charge that includes collaborating closely with ORA leadership to enhance the federal-state partnership. Dr. Jeff Farrar will play this leadership role.
- Integration Task Force: The Commissioner has charged the Deputy Commissioner for Foods and the Deputy Commissioner for Global Regulatory Operations and Policy to establish a high-level Integration Task Force that will oversee on their behalf the development and implementation of new strategies and action plans to achieve full partnership with state and local agencies. The Integration Task Force will be co-chaired by Joe Reardon of ORA and Jeff Farrar of the Office of Foods, both of whom have led state food regulatory programs. The members of the Task Force will include senior officials from ORA, the Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, and state and local agencies involved in the Partnership for Food Protection.
Developing Strategies and Action Plans
The Integration Task Force will identify and address the enhancements needed within FDA to ensure full adoption of an integrated food safety system, with immediate priority given to addressing the following topics:
- The strengths and weaknesses of the current federal-state partnership, taking into account the perspectives of officials from FDA and state and local agencies.
- Current federal policies and practices that are fostering and impeding development of full partnership.
- Specific actions FDA leadership can take to institutionalize the communication and operational practices required to achieve full partnership.
- An agenda for taking full advantage of FSMA’s mandate for an integrated food safety system that strengthens the state and local role in the food safety system and build a full partnership.
This initial report and recommendations of the Task Force will be submitted January 31, 2012.