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  5. FSMA Rules & Guidance for Industry
  1. Food Safety Modernization Act (FSMA)

FSMA Rules & Guidance for Industry

Rules and Guidance for Industry related to the FDA Food Safety Modernization Act (FSMA). 

Rules

Title Issued Date

Final Rule: Pre-Harvest Agricultural Water
Docket Number: FDA-2021-N-0471

 2024/05

Final Rule: Requirements for Additional Traceability Records for Certain Foods
Docket Number: FDA-2014-N-0053

 2022/11

Final Rule: Laboratory Accreditation for Analyses of Foods (LAAF)
Docket Number: FDA-2019-N-3325

 2021/12

Final Rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Docket Number: FDA-2011-N-0920

 2018/09

Final Rule: Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program 
Docket Number: FDA-2011-N-0146

 2017/01

Final Rule: Amendments to Registration of Food Facilities
Docket Number: FDA-2002-N-0323

 2016/07

Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration
Docket Number: FDA-2013-N-1425

 2016/05

Final Rule: Sanitary Transportation of Human and Animal Food
Docket Number: FDA-2013-N-0013

 2016/04

Final Rule: Accredited Third-Party Certification
Docket Number: FDA-2011-N-0146

 2015/11

Final Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  
Docket Number: FDA-2011-N-0921
Extension of Compliance Dates for Subpart E (March 2019)
Technical Amendment (April 2019) 
Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules (August 2016)
Technical Amendment (May 2016) 

 2015/11

Final Rule: Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
Docket Number: FDA-2011-N-0143
Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules (August 2016)

 2015/11

Final Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food 
Docket Number: FDA-2011-N-0920
Technical Amendment (April 2019) 
Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules (August 2016)
Clarification of Compliance Date for Certain Food Establishments (November 2015)

 2015/09

Final Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Docket Number: FDA-2011-N-0922
Technical Amendment (April 2019)
Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules (August 2016)

 2015/09

Proposed Rule: User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
Docket Number: FDA-2011-N-0146
Correction Notice

 2015/07

Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
Docket Number: FDA-2002-N-0153 (Formerly Docket No. 2002N-0277)

 2014/04

Advance Notice of Proposed Rulemaking: Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act
Docket Number: FDA-2013-N-0590

 2014/03

Final Rule: Information Required in Prior Notice of Imported Food
Docket Number: FDA-2011-N-0179

 2013/05

Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
Docket Number: FDA-2011-N-0197

 2013/02

Guidance for Industry & Others

Title Issued Date
Guidance for Industry: FDA's Voluntary Qualified Importer Program
Docket Number: FDA-2011-N-0144		 2024/11
Revised
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Revised Introduction and Appendix 1
Docket Number: FDA-2016-D-2343		 2024/01
Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption
Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption
Docket Number: FDA-2017-D-0175		 2023/09
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 11: Food Allergen Program & Chapter 16: Acidified Foods
Docket Number: FDA-2016-D-2343		 2023/09
Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19
Docket Number: FDA-2020-D-1108		 2023/07
Guidance for Industry: Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19
Docket Number: FDA-2020-D-1304		 2023/07
Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide 
Docket Number: FDA-2023-D-1336		 2023/05
Guidance for Industry: Transition from 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
Docket Number: FDA-2023-D-1031		 2023/04
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Docket Number: FDA-2017-D-5225		 2023/01
Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government
Docket Number: FDA-2017-D-6528		 2022/10
Guidance for Industry: Laboratory Accreditation for Analyses of Foods - What You Need to Know; Small Entity Compliance Guide 
Docket Number: FDA-2022-D-1126		 2022/10
Guidance for Industry: CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Docket Number: FDA-2018-D-0388		 2022/07
Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting 
Docket Number: FDA-2019-D-4534		 2022/05
Draft Guidance for Industry: The Accredited Third-Party Certification Program: Questions and Answers 
Docket Number: FDA-2022-D-0370		 2022/04
Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation
Docket Number: FDA-2011-N-0143		 2022/04
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 
Docket Number: FDA-2021-D-0563		 2022/03
Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards 
Docket Number: FDA-2011-N-0146		 2022/02 Revised
Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act
Docket Number: FDA-2017-D-3716		 2021/12
Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act
Docket Number: FDA-2017-D-3716		 2021/12
Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act
Docket Number: FDA-2017-D-3716		 2021/12
Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period      2021/03
Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration 2020/10
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 - - No longer in effect
Docket Number: FDA-2020-D-1386		 2020/05
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
Docket Number: FDA-2018-D-1398		 2020/02
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 14: Recall Plan
Docket Number: FDA-2016-D-2343		 2019/10
Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507
Docket Number: FDA-2018-D-0671		 2019/06
Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Docket Number: FDA-2019-D-2131		 2019/06
Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds
Docket Number: FDA-2019-D-1266		 2019/03
Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
Docket Number: FDA-2018-D-1398		 2019/03
Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls
Docket Number: FDA-2015-D-0138		 2018/11
Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Docket Number: FDA-2018-D-3631		 2018/10
Guidance for Industry: Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AND Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Docket Number: FDA-2016-D-1164		 2018/09
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
Docket Number: FDA-2012-D-1002		 2018/08
Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration
Docket Number: FDA-2012-D-1002		 2018/08
Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
Docket Number: FDA-2018-D-1398		 2018/06
Guidance for Industry: #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program 
Docket Number: FDA-2018-D-1861		 2018/06
Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide 
Docket Number: FDA-2018-D-1468		 2018/05
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
Docket Number: FDA-2018-D-1378		 2018/05
Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals
Docket Number: FDA-2018-D-0721		 2018/03
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 
Docket Number: FDA-2011-N-0143		 2018/01
Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities 
Docket Number: FDA-2017-D-6592		 2018/01
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 
Docket Number: FDA-2017-D-0397		 2018/01
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 15: Supply-Chain Program for Human Food Products 
Docket Number: FDA-2016-D-2343		 2018/01
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
Docket Number: FDA-2017-N-6908		 2018/01
Guidance for Industry: Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide
Docket Number: FDA-2013-N-0013		 2017/11
Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food
Docket Number: FDA-2017-D-5996		 2017/11
Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals
Docket Number: FDA-2016-D-1229		 2017/10
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507
Docket Number: FDA-2017-D-6133		 2017/10
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
Docket Number: FDA-2011-N-0921		 2024/09
Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide
Docket Number: FDA-2013-N-1425		 2017/08
Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule
Docket Number: FDA-2013-N-0013		 2017/08
Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation
Docket Number: FDA-2011-N-0143		 2017/03
Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods
Docket Number: FDA-2008-D-0096		 2017/01
Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
Docket Number: FDA-2012-D-1002		 2016/11
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
Docket Number: FDA-2011-N-0920		 2016/10
Guidance for Industry: Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Docket Number: FDA-2011-N-0922		 2016/10
Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA
Docket Number: FDA-2016-D-2841		 2016/10
Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)
Docket Number: FDA-2012-D-0585		 2016/09
Draft Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals
Docket Number: FDA-2016-D-1229		 2016/08
Draft Guidance for Industry: Human Food By-Products for Use as Animal Food
Docket Number: FDA-2016-D-1220		 2016/08
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities
Docket Number: FDA-2016-D-2373		 2016/08
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
Docket Number: FDA-2016-D-2343		 2016/08
Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
Docket Number: FDA-2011-N-0179		 2016/06
Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
Docket Number: FDA-2011-N-0146		 2015/07
Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide
Docket Number: FDA-2013-N-1421		 2014/04
Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
Docket Number: FDA-2011-D-0674		 2014/04
Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide
Docket Number: FDA-2011-D-0643		 2013/03
SUPERCEDED: Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide
Docket Number: FDA-2012-D-1003
See Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide		 2012/12
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)
Docket Number: FDA-2011-D-0598		 2012/02
Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
Docket Number: FDA-2011-D-0721		 2011/09
WITHDRAWN Guidance for Industry: Enforcement Policy Concerning Certain Prior Notice Requirements 2011/06
Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues
Docket Number: FDA-2011-D-0376		 2016/08
Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance
Docket Number: FDA- 2011-D-0287		 2011/04

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