Food Safety Modernization Act

Government Publications

FDA At A Glance

FDA, Key Requirements: FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (May 16, 2016)

FDA, Key Requirements: Final Rule on Sanitary Transportation of Human and Animal Food (Apr. 5, 2016)

FDA, Key Requirements: Final Rule on Preventive Controls for Human Food (Sep. 10, 2015)

FDA, Key Requirements: Final Rule on Preventive Controls for Animal Food (Created Sep. 10, 2015; Updated Oct. 12, 2017)

FDA, Key Requirements: Final Rule on Produce Safety (Nov. 13, 2015)

FDA, Key Requirements: Final Rule on Accredited Third-Party Certification (Nov. 13, 2015)

FDA, Key Requirements: Final Rule on Foreign Supplier Verification Programs (Created Nov. 13, 2015; Updated May 11, 2017)

FDA Guidance Materials

Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period (Mar. 2021) Docket Number: FDA-2012-D-1002

Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration (Oct. 2020) Docket Number: FDA-2012-D-1002

Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency (Jun. 2020) Docket Number: FDA-2020-D-1108

Guidance for Industry: Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (May 2020) Docket Number: FDA-2020-D-1386

Guidance for Industry: Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency (Apr. 2020) Docket Number: FDA-2020-D-1304

Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (Feb. 2020) Docket Number: FDA-2018-D-1398

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 14: Recall Plan (Oct. 2019) Docket Number: FDA-2016-D-2343

Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (Jun. 2019) Docket Number: FDA-2018-D-0671

Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Jun. 2019) Docket Number: FDA-2019-D-2131

Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Jun. 2019) Docket Number: FDA-2018-D-3631

Draft Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (Jun. 2019) Docket Number: FDA-2018-D-0671

Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds (Mar. 2019) Docket Number: FDA-2019-D-1266

Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (Mar. 2019) Docket Number: FDA-2018-D-1398

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (Mar. 2019) Docket Number: FDA-2018-D-1861

Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls (Nov. 2018) Docket Number: FDA-2015-D-0138

Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls (Sep. 2018) Docket Number: FDA-2015-D-0138

Guidance for Industry: Determination of Status as a Qualified Facility (Sep. 2018) Docket Number: FDA-2016-D-1164

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Aug. 2018) Docket Number: FDA-2012-D-1002

Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration (Aug. 2018) Docket Number: FDA-2012-D-1002

Guidance for Industry: The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide (May 2018) Docket Number: FDA-2018-D-1378

Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide (May 2018) Docket Number: FDA-2018-D-1468

Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation (Mar. 2018) Docket Number: FDA-2011-N-0143

Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals (Mar. 2018) Docket Number: FDA-2018-D-0721

Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Jan. 2018) Docket Number: FDA-2017-D-5225

Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide (Jan. 2018) Docket Number: FDA-2011-N-0143

Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities (Jan. 2018) Docket Number: FDA-2017-D-6592

Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 (Jan. 2018) Docket Number: FDA-2017-D-0397

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Jan. 2018) Docket Number: FDA-2016-D-2343

Draft Guidance for Industry: #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Jan. 2018) Docket Number: FDA-2018-D-0388

Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Jan. 2018) Docket Number: FDA-2017-N-6908

Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government (Dec. 2017) Docket Number: FDA-2017-D-6528

Guidance for Industry: Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation – Small Entity Compliance Guide (Nov. 2017) Docket Number: FDA-2013-N-0013

Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food (Nov. 2017) Docket Number: FDA-2017-D-5996

Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (Oct. 2017) Docket Number: FDA-2017-D-6133

Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals (Oct. 2017) Docket Number: FDA-2016-D-1229

Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation – Small Entity Compliance Guide (Sep. 2017) Docket Number: FDA-2011-N-0921

Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule (Aug. 2017) Docket Number: FDA-2013-N-0013

Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (Aug. 2017) Docket Number: FDA-2017-D-3716

Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (Aug. 2017) Docket Number: FDA-2017-D-3716

Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (Aug. 2017) Docket Number: FDA-2017-D-3716

Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration – What You Need to Know About the FDA Regulation: Small Entity Compliance Guide (Aug. 2017) Docket Number: FDA-2013-N-1425

Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation (Mar. 2017) Docket Number: FDA-2011-N-0143

Draft Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations (Jan. 2017) Docket Number: FDA-2017-D-0175

Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Jan. 2017) Docket Number: FDA-2008-D-0096

Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (Dec. 2016) Docket Number: FDA-2011-N-0146

Guidance for Industry: FDA’s Voluntary Qualified Importer Program (Nov. 2016) Docket Number: FDA-2011-N-0144

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide (Oct. 2016) Docket Number: FDA-2011-N-092

Guidance for Industry: Small Entity Compliance Guide – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Oct. 2016) Docket Number: FDA-2011-N-0922

Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (Oct. 2016) Docket Number: FDA-2016-D-2841

Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) (Sep. 2016) Docket Number: FDA-2012-D-0585

Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (Aug. 2016) Docket Number: FDA-2011-D-0376

Draft Guidance for Industry: Human Food By-Products for Use as Animal Food (Aug. 2016) Docket Number: FDA-2016-D-1220  

Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Aug. 2016) Docket Number: FDA-2016-D-2373

Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) (Jun. 2016) Docket Number: FDA-2011-N-0179

Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide (Apr. 2014) Docket Number: FDA-2013-N-1421

Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (Apr. 2014) Docket Number: FDA-2011-D-0674

Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide (Mar. 2013) Docket Number: FDA-2011-D-0643

Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (Feb. 2012) Docket Number: FDA-2011-D-0598

Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance (Fourth Edition) (Apr. 2011) Docket Number: FDA- 2011-D-0287

FDA Reports

FDA Reports & Studies (FDA List of Reports Online)

Biennial Report to Congress on the Food Safety and Food Defense Research Plan (May 2015)

Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm: Response to Public Comments (Aug. 2015)

Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (Aug. 2015)

2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices (Nov. 2013)

Building Domestic Capacity to Implement the FDA Food Safety Modernization Act – 2013 Report (May 2013)

2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices (Aug. 2012)

2011 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices (Apr. 2011)

Congressional Research Service

U.S. Food and Agricultural Imports: Safeguards and Selected Issues, R46440 (Jul. 1, 2020)

Foodborne Illnesses and Outbreaks from Fresh Produce, IF11092 (Feb. 4, 2019)

The Federal Food Safety System: A Primer, RS22600 (Dec. 16, 2016)

Implementation of the FDA Food Safety Modernization Act, R43724 (Dec. 16, 2016)

Food Safety Issues for the 114th Congress, R42885 (Apr. 10, 2015)

Food Recalls and Other FDA Administrative Enforcement Actions, R43794 (Nov. 20, 2014)

Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients, R43358 (Jan. 10, 2014)

Food Safety Issues for the 112th Congress, R41629 (Jan. 9, 2012)

The FDA Food Safety Modernization Act, R40443 (Feb. 18, 2011)

Food Safety on the Farm, RL34612 (Jan. 18, 2011)

U.S. Government Accountability Office

Imported Food Safety: FDA’s Targeting Tool Has Enhanced Screening, but Further Improvements Are Possible, GAO-16-399 (May 2016)

FDA Coordinating with Stakeholders on New Rules but Challenges Remain and Greater Tribal Consultation Needed, GAO-16-425 (May 2016)

Additional Actions Needed to Help FDA’s Foreign Offices Ensure Safety of Imported Food, GAO-15-183 (Jan. 2015)