FSMA Reports & Studies

The Food Safety and Modernization Act (FSMA) requires special reports to Congress and studies on FDA's activities and impact of FSMA. Below is a listing of those reports and studies.

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Reports Required by Law 

• Report on fees collected
  • 2023 Report on User Fees Assessed and Collected (PDF: 223KB)
  • 2022 Report on User Fees Assessed and Collected (PDF: 195KB)
  • 2021 Report on User Fees Assessed and Collected (PDF: 242KB) 
  • 2020 Report on User Fees Assessed and Collected (PDF: 36KB) 
• Report on Food Emergency Response Network
  • 2019 Report on the Food Emergency Response Network (PDF: 124KB)
  • 2015/2017 Report on the Food Emergency Response Network (PDF: 110KB)
  • 2013 Biennial Report on the Food Emergency Response Network
  • 2011 Biennial Report on the Food Emergency Response Network  
• Report on national agriculture and food defense strategy, implementation plan, and research plan
  • 2019 Report on the National Agriculture and Food Defense Strategy (NAFDS)
  • 2015 Report on the National Agriculture and Food Defense Strategy (NAFDS)
• Report on pilot projects on product tracing
  • 2017 Report on Enhancing Tracking and Tracing of Food and Recordkeeping (PDF: 34,908KB)
• Report on Use of Mandatory Recall Authority
  • 2023 Report on the Use of Mandatory Recall Authority (PDF: 204KB)
  • 2022 Report on the Use of Mandatory Recall Authority (PDF: 197KB)
  • 2021 Report on the Use of Mandatory Recall Authority (PDF: 258KB)
  • 2020 Report on the Use of Mandatory Recall Authority (PDF: 72KB)
  • 2019 Report on the Use of Mandatory Recall Authority (PDF: 60KB)
  • 2018 Report on the Use of Mandatory Recall Authority (PDF: 81.1KB)
  • 2017 Report on the Use of Mandatory Recall Authority (PDF: 50KB)
  • 2016 Report on the Use of Mandatory Recall Authority (PDF: 50KB)
  • 2015 Report on the Use of Mandatory Recall Authority
  • 2014 Report on the Use of Mandatory Recall Authority
  • 2013 Report on the Use of Mandatory Recall Authority
• Report on food facilities, food imports, and foreign offices, including efforts to cooperate with other agencies
  • 2013 Report on Food Facilities, Food Imports, and FDA Foreign Offices
  • 2012 Report on Food Facilities, Food Imports, and FDA Foreign Offices
  • 2011 Report on Food Facilities, Food Imports, and FDA Foreign Offices
• Reports on international food safety capacity-building
  • 2013 International Food Safety Capacity-Building Plan (PDF: 5.7MB)
• Report on the basis for selecting countries with foreign offices, their progress, and plans for additional foreign offices
  • 2012 Report on the FDA Foreign Office
• Study and report on the food processing sector
  • 2015 Report on Food Processing Sector Study
• Report on programs and practices to promote for safety and supply chain security of food
  • 2013 Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA)
• Report on the Joint HHS/USDA food safety and food defense research plan
  • 2015 Biennial Report on the Food Safety and Food Defense Research Plan
• Report on post-harvest processing of raw oysters regulation 
• DHS report on activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council
• Report and evaluation of effectiveness of programs administered by HHS
• Study and report on unique identification numbers
• Report of food safety programs, outlining successes and future programs
• Study on food transportation

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Sections of the Law Relating to Reports & Studies

• SEC 103. Hazard analysis and risk-based preventive controls
• SEC 107. Authority to collect fees
• SEC 108. National agriculture and food defense strategy
• SEC 109. Food and Agriculture Coordinating Councils
• SEC 110. Building domestic capacity
• SEC 111. Sanitary transportation of food
• SEC 114. Requirement for guidance relating to post harvest processing of raw oysters
• SEC 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
• SEC 202. Laboratory accreditation for analyses of foods
• SEC 204. Enhancing tracking and tracing of food and recordkeeping
• SEC 206. Mandatory recall authority
• SEC 305. Building Capacity of Foreign Governments with Respect to Food Safety 
• SEC 308. Foreign offices of the Food and Drug Administration