Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18) Clinical Trials Not Allowed

Description

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP) is announcing the availability of cooperative agreements to be awarded under Limited Competition to State, local, territorial, or tribal retail food regulatory programs. The intended outcome of the FOA is to advance efforts for a nationally integrated food safety system through the conformance with an advancement of the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS or Retail Program Standards). The VNRFRPS apply to the operation and management of a retail food regulatory program that is focused on the reduction of risk factors known to contribute to foodborne illness and the promotion of industry action to achieve active managerial control of these risk factors. The Retail Program Standards include nine individual Program Standards. Each Program Standard has one or more corresponding worksheets, forms and guidance documents. While the Retail Program Standards represent a model of the effective, focused food safety program, they begin by providing a foundation and system upon which all regulatory programs can build through a continuous improvement process. The Retail Program Standards encourage regulatory agencies to improve and build upon existing programs. Further, the Retail Program Standards provide a framework designed to accommodate both traditional and emerging approaches to food safety. The Retail Program Standards are intended to reinforce proper sanitation (good retail practices) and operational and environmental prerequisite programs while encouraging regulatory agencies and industry to focus on the factors that cause and contribute to foodborne illness, with the ultimate goal or reducing the occurrence of those factors. BACKGROUND This funding opportunity furthers FDA's support of state, local, territorial, and tribal retail food safety programs. The purpose of this support system will be to assist these agencies in advancing efforts for a nationally integrated food safety system through research, planning, establishment, and/or enhancement of state and territorial retail food regulatory programs. Recent legislative and strategic initiatives have addressed FDA's relationship with state, local, territorial and tribal authorities in retail food protection activities. Please visit http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/default.htm for more information. a. Retail Food Safety Initiative Announced in October 2010, the Retail Food Safety Initiative is part of the Food and Drug Administration’s overall prevention-based, farm-to-table food safety strategy to reduce foodborne illness. The FDA actions in this initiative are prompted by a 10-year study of more than 800 retail food establishments to determine compliance with five key risk factors in nine types of retail operations. FDA's partnerships with the retail food industry; state, local, territories and tribal authorities; and other government agencies are a foundational building block of the initiative and key to its success in four action areas: Make the presence of certified food protection managers common practice. Strengthen active managerial controls at the retail level and ensure better compliance. Encourage widespread, uniform, and complete adoption of the FDA Food Code. Create an enhanced local regulatory environment for retail food operations. To help create an enhanced local regulatory environment for retail food operations, FDA is committed to: (1) Promoting wider implementation by state, local and tribal regulatory programs of the FDA Voluntary National Retail Food Regulatory Programs Standards; (2) Ensuring universal participation by local regulators in consistent, high-quality training through increased access and increased portability and transferability of FDA courses; and (3) Seeking increased multi-year funding for the state, local and tribal programs as part of an integrated food safety system. b. Food and Drug Administration Amendments Act of 2007 (FDAAA) Under section 1004 of FDAAA (21 U.S.C. 2104), the Secretary of the Department of Health and Human Services (which includes FDA) is required to work with the states to improve food safety. Section 1004(a) of FDAAA (21 U.S.C. 2104(a)) states that the Secretary shall provide assistance to encourage states to: (1) Establish, continue, or strengthen state food safety programs, especially with respect to the regulation of retail commercial food establishments; and (2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of state food safety programs is not unsafe for human consumption. This assistance to plan, develop, and implement such a food safety program may include: (1) Advisory assistance; (2) Technical assistance, training, and laboratory assistance; and (3) Financial and other assistance (21 U.S.C. 2104(b)). c. FDA Food Safety Modernization Act The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, and suspension of facility registration. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods. FSMA directs FDA to build an integrated national food safety system in partnership with state and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas such as: reliance on federal, state, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing state and local food safety and defense capacities. OBJECTIVES When first enrolling in the Retail Program Standards, retail regulatory programs are encouraged to conduct a comprehensive self-assessment to identify program needs and then establish priorities to maximize the effectiveness of resources. Post self-assessment, cooperative agreement funds shall be used to enhance or establish systems to: a. Address gaps identified through the self-assessment process to achieve greater conformance with the Retail Program Standards; b. Complete a risk factor study (or track routine inspection data) to identify the foodborne illness risk factors most in need of priority attention; and/or c. Implement intervention strategies to reduce the occurrence of foodborne illness risk factors (Intervention strategies are defined as a comprehensive set of activities, initiatives, or specific tools implemented on the part of industry and/or regulators that are designed to bring about immediate and/or long-term control of foodborne illness risk factors). The cooperative agreements that will be funded through this FOA are intended to develop, implement, and continuously improve the infrastructure and effectiveness of retail food programs using the VNRFRPS. Under the resulting cooperative agreements, state, local, territorial, or tribal jurisdictions will implement a continuous program improvement/enhancement strategy (action plan) using the VNRFRPS. The action plan will identify activities, timeframes, personnel and other resources required for implementation of the improvement/enhancement strategy. Funds may be utilized for a variety of activities and those allowable expenses are listed in Section IV. OUTCOMES The intended outcomes of the work provided under the resulting cooperative agreements are as follows: 1. Retail food regulatory programs demonstrate increased conformance by meeting part or all of standards criteria within the Retail Program Standards; 2. Retail food regulatory programs complete a risk factor study (or track routine inspection data) to identify the foodborne illness risk factors most in need of priority attention; 3. Retail food regulatory programs develop and implement intervention strategies to reduce the occurrence of foodborne illness risk factors in need of priority attention; 4. Retail food regulatory programs develop and implement training programs to ensure staff is adequately trained, able to train others, and/or standardized, in conformance with the Retail Program Standards; 5. Retail food regulatory programs develop and implement an action plan that justifies the need for resources including, but not limited to, equipment, personnel, or software to address gaps identified in the Program Standards self-assessment; and/or 6. Retail food regulatory programs leverage other jurisdictions and/or organizations to assist in achieving conformance with one or more standards, conduct risk factor studies (or track routine inspection data), develop and implement intervention strategies, develop/deliver training programs, or otherwise build capacity to more effectively prevent foodborne illness and/or more effectively and efficiently respond to foodborne illness outbreaks, should they occur. Only state, local, territorial, and tribal agencies with primary regulatory responsibilities for retail food establishments, or those government agencies with substantial involvement and control over such agencies are eligible to apply. In addition, the retail food regulatory agency must be enrolled in the VNRFRPS and have completed a current self-assessment against all nine (9) Retail Program Standards. Upon submission of the completed enrollment form, FDA will add the jurisdiction to its on-line Listing of Jurisdictions Enrolled in the Voluntary National

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