Food Safety Modernization Act (FSMA)

The FDA Food Safety Modernization Act (FSMA) The most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

Other Documents & Guidance for Industry

• Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions (FDA, March 2022) (PDF 308 KB)
• FSMA Frequently Asked Questions
• FDA en Espanol - Contains links to FSMA documents for industry in Spanish, as well as consumer links and other information. 
• All current guidance documents for the food industry, on a searchable page.  
• Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide
• Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls (FDA) (as PDF 114 KB)
• Guidance for Industry - Q & A Regarding Food Facility Registration (7th Edition) (FDA)
• Draft Guidance for Industry - Supplemental Q & A Regarding Food Facility Registration (FDA)
• FSPCA Food Defense Awareness for the Intentional Adulteration Rule - Free Online Course
• Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide (FDA)

Final Rule on Preventive Controls for Human Food

• FSMA Final Rules for Preventive Controls for Human Food (FDA)
• Preventive Controls for Human Food Rule: Code of Federal Regulations Ch. 21 Title 117 (ecfr.gov) (PDF 329 KB) 

Other Documents and Guidance for Industry

• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (FDA) (PDF 2.4 MB)
• Key Facts about Preventive Controls for Human Food (FDA) (Opens as download; PDF 93 KB)

Final Rule on Preventive Controls for Animal Food

• FSMA Final Rules for Preventive Controls for Animal Food (FDA)

Other Documents and Guidance for Industry

• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (FDA) (PDF 302 KB) (See Final Rule Here)

Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

• FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

Other Documents & Guidance for Industry 

• Am I subject to FSVP? (PDF 69 KB) (Nov. 13, 2015)
• Compliance Dates for the Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (Dec. 13, 2016)
• FSVP Factsheet (PDF 270 KB) (Nov. 13, 2015)
• Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation (FDA) (March 2017)
• Export Document Program (California Dept. of Public Health)
  For exporting California food products to other countries.

Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

• FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

Other Documents & Guidance for Industry 

• Food Defense Plan Builder (FDA) The Food Defense Plan Builder (FDPB) version 2.0 is a user-friendly tool designed to help owners and operators of a food facility in the development of a food defense plan that is specific to their facility and may assist them with meeting the requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121).

Final Rule on Requirements for Additional Traceability Records for Certain Foods

• FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
• FDA Publishes New FAQs and Additional Tools for the Food Traceability Rule (updated June 2024)
  • Downloadable, Electronic Sortable Spreadsheet Template (opens in Microsoft Excel, 1.9 KB) (as PDF, 804 KB)
  • Exemptions Relevant to Produce Farms Under the Produce Safety Rule and the Food Traceability Rule
  • New FAQ summarizing recent changes
  • New translated material regarding the Traceability Lot Code
  • Supply Chain Example for Sprouts
• Food Traceability List
• Small Entity Compliance Guide for the Food Safety Modernization Act (FSMA) Food Traceability Rule (FDA, May 18, 2023)

Final Rule on Sanitary Transportation of Human and Animal Food

• FSMA Final Rule on Sanitary Transportation of Human and Animal Food

Final Rule on Accredited Third-Party Certification

• FSMA Final Rule on Accredited Third-Party Certification

Other Resources on FSMA

Food Safety Preventive Controls Alliance   

From the website https://www.fspca.net/about-fspca: Food Safety Preventive Controls Alliance (FSPCA) is a broad-based public-private alliance consisting of key industry, academic and government stakeholders whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing  human and animal food in complying with the preventive controls regulations that will be part of the Food Safety Modernization Act (FSMA).

FSMA National Centers and Alliances

• Western Regional Center to Enhance Food Safety
• North Central Region for FSMA Training, Extension and Technical Assistance
  • FSMA Human Food Audit Checklist (Iowa State University North Central Region FSMA) (PDF 648 KB)
  • Resources developed by Iowa State University NCRFSMA 
    • Includes Fact sheets, Worksheets, Water-testing labs
    • GAP Training Videos in Hmong (with English subtitles)
    • Online Quizzes for individual states to understand state-specific laws pertaining to Value Added Products (scroll down on page)
• The Northeast Center to Advance Food Safety
• USDA-NIFA Southern Regional Food Safety Center
• Indigenous Food and Agriculture Initiative
• International Food Protection Training Institute
• Local Food Safety Collaborative