Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories (U18 Clinical Trial Not Allowed)

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Performance Measures Due to the need for accountability as required by the Uniform Guidance 2 CFR 200, an emphasis will be placed on the applicant’s ability to measure progress and track performance using objective, proven and measurable data. As such, applicants shall propose how they will develop and implement a performance measurement system, plan, and/or process and shall carefully consider the Scored Review Criteria listed in Section V of this announcement when submitting their application. Background Over the past several years, the food safety system has continually encountered risks and emergencies of significant national concern. Multiple efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the food safety system. a. President’s Food Safety Working Group An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009 (http://www.foodsafetyworkinggroup.gov/Home.htm). The charge of the FSWG is the following: “To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe and will be enforced.” Chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes prevention, strengthens surveillance and enforcement, and improves response and recovery. b. National Integrated Food Safety System FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system. Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and the programs supported by these cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate to identify means to improve and optimize the nation’s food safety system. The Partnership for Food Protection (http://www.fda.gov/ForFederalStateandLocalOfficials/Meetings/ucm249828.htm) is a major driving force in the establishment of a national integrated food safety system. In alignment with this concept, these cooperative agreements work to engage partners across multiple sectors of the food safety system to collaborate to identify means of improving and optimizing the nation’s food safety system. c. 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, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. 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. Full text of the law: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm Program Objectives The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP), in collaboration with the Office of Regulatory Science (ORS) and the Center for Food Safety and Applied Nutrition (CFSAN), is announcing the availability of up to twenty-eight (28) awards for ISO/IEC 17025 accreditation maintenance and enhancement for State laboratories, up to fourteen (14) awards for whole genome sequencing activities for State laboratories, and one (1) award for state ISO/IEC 17025 accreditation and whole genome sequencing support by an association to be awarded under Limited Competition. The intended outcome of this cooperative agreement is to advance the goal of a national food safety system by supporting and enhancing state food laboratory activities including: 1. Ensuring microbiological and chemical food analyses performed on behalf of the State manufactured food regulatory programs are conducted within the scope of an ISO/IEC 17025 accredited laboratory; 2. Strengthening the collaboration between the laboratories and State manufactured food regulatory programs; 3. Increasing the number of State samples collected and analyzed for surveillance purposes annually; 4. Developing a stronger international rapid surveillance system for pathogen traceback through the GenomeTrakr network using a minimum set of metadata fields for all food and environmental isolates; and 5. Providing additional support to the State food laboratories through an outside association to offer trainings, workshops, meetings and other educational resources to awardees under this cooperative agreement and to unfunded laboratories seeking ISO/IEC 17025 accreditation.

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