FSMA Rules & Guidance for Industry

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

Rules
Guidance for Industry & Others

Rules

Title	Issued Date
Proposed Rule: Agricultural Water Docket Number: FDA-2021-N-0471	2021/12
Final Rule: Laboratory Accreditation for Analyses of Foods (LAAF) Docket Number: FDA-2019-N-3325	2021/12
Proposed Rule: Food Traceability Docket Number: FDA-2014-N-0053	2020/09
Final Rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Docket Number: FDA-2011-N-0920	2018/09
Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E Docket Number: FDA-2011-N-0921	2017/09
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: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules Docket Number: FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, FDA-2011-N-0143	2016/08
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	2015/11
Final Rule: Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Docket Number: FDA-2011-N-0143	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 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; 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	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: 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 Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency Docket Number: FDA-2020-D-1108	2020/06
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 Docket Number: FDA-2020-D-1386	2020/05
Guidance for Industry: Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency Docket Number: FDA-2020-D-1304	2020/04
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
Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Docket Number: FDA-2017-D-5225	2018/01
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: #245 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Docket Number: FDA-2018-D-0388	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
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government Docket Number: FDA-2017-D-6528	2017/12
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	2017/09
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: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation Docket Number: FDA-2011-N-0143	2017/05
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: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations Docket Number: FDA-2017-D-0175	2017/01
Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods Docket Number: FDA-2008-D-0096	2017/01
Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards Docket Number: FDA-2011-N-0146	2016/12
Guidance for Industry: FDA's Voluntary Qualified Importer Program Docket Number: FDA-2011-N-0144	2016/11
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

Rules

Guidance for Industry & Others

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