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                Food Safety Modernization Act (FSMA)

Food Safety Modernization Act (FSMA)

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

Rules
	Guidance for Industry & OthersRules

Title
			Issued DateFinal Rule: Requirements for Additional Traceability Records for Certain Foods
			Docket Number: FDA-2014-N-0053
			2022/11Proposed Rule: Agricultural Water 
			Docket Number: FDA-2021-N-0471
			2021/12Final Rule: Laboratory Accreditation for Analyses of Foods (LAAF)
			Docket Number: FDA-2019-N-3325
			2021/12Final Rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
			Docket Number: FDA-2011-N-0920
			2018/09Final 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
			2017/01Final Rule: Amendments to Registration of Food Facilities
			Docket Number: FDA-2002-N-0323
			2016/07Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration
			Docket Number: FDA-2013-N-1425
			2016/05Final Rule: Sanitary Transportation of Human and Animal Food
			Docket Number: FDA-2013-N-0013
			2016/04Final Rule: Accredited Third-Party Certification
			Docket Number: FDA-2011-N-0146
			2015/11Final 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)
			2015/11Final 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)
			2015/11Final 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)
			2015/09Final 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)
			2015/09Proposed 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-0146Correction Notice
			2015/07Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
			Docket Number: FDA-2002-N-0153 (Formerly Docket No. 2002N-0277)
			2014/04Advance 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
			2014/03Final Rule: Information Required in Prior Notice of Imported Food 
			Docket Number: FDA-2011-N-0179
			2013/05Final 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

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
			2024/01Guidance 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
			2023/09Draft 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
			2023/09Guidance 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
			2023/07Guidance 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
			2023/07Guidance 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
			2023/05Guidance 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
			2023/04Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
			Docket Number: FDA-2017-D-5225
			2023/01Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government
			Docket Number: FDA-2017-D-6528
			2022/10Guidance for Industry: Laboratory Accreditation for Analyses of Foods - What You Need to Know; Small Entity Compliance Guide 
			Docket Number: FDA-2022-D-1126
			2022/10Guidance for Industry: CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
			Docket Number: FDA-2018-D-0388
			2022/07Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting 
			Docket Number: FDA-2019-D-4534
			2022/05Draft Guidance for Industry: The Accredited Third-Party Certification Program: Questions and Answers 
			Docket Number: FDA-2022-D-0370
			2022/04Guidance 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
			2022/04Guidance 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
			2022/03Guidance for Industry: FDA's Voluntary Qualified Importer Program
			Docket Number: FDA-2011-N-0144
			2022/03
			(revised)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
			2021/12Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act
			Docket Number: FDA-2017-D-3716
			2021/12Guidance 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
			2021/12Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period
			2021/03Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration
			2020/10Guidance 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
			2020/05Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
			Docket Number: FDA-2018-D-1398
			2020/02Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 14: Recall Plan
			Docket Number: FDA-2016-D-2343
			2019/10Guidance 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
			2019/06Draft 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
			2019/06Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds
			Docket Number: FDA-2019-D-1266
			2019/03Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
			Docket Number: FDA-2018-D-1398
			2019/03Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls
			Docket Number: FDA-2015-D-0138
			2018/11Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
			Docket Number: FDA-2018-D-3631
			2018/10Guidance 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
			2018/09Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
			Docket Number: FDA-2012-D-1002
			2018/08Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration
			Docket Number: FDA-2012-D-1002
			2018/08Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
			Docket Number: FDA-2018-D-1398
			2018/06Guidance for Industry: #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program 
			Docket Number: FDA-2018-D-1861
			2018/06Guidance 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
			2018/05Guidance 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
			2018/05Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals
			Docket Number: FDA-2018-D-0721
			2018/03Guidance 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
			2018/01Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities 
			Docket Number: FDA-2017-D-6592
			2018/01Draft 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
			2018/01Draft 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
			2018/01Guidance 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
			2018/01Guidance 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
			2017/11Guidance 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
			2017/11Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals
			Docket Number: FDA-2016-D-1229
			2017/10Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507
			Docket Number: FDA-2017-D-6133
			2017/10Guidance 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
			2017/09Guidance 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
			2017/08Guidance 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
			2017/08Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation
			Docket Number: FDA-2011-N-0143
			2017/03Draft Guidance for Industry: Control of *Listeria monocytogenes*in Ready-To-Eat Foods
			Docket Number: FDA-2008-D-0096
			2017/01Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
			Docket Number: FDA-2012-D-1002
			2016/11Guidance 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
			2016/10Guidance 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
			2016/10Draft 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
			2016/10Guidance 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
			2016/09Draft Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals
			Docket Number: FDA-2016-D-1229
			2016/08Draft Guidance for Industry: Human Food By-Products for Use as Animal Food
			Docket Number: FDA-2016-D-1220
			2016/08Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities
			Docket Number: FDA-2016-D-2373
			2016/08Draft Guidance for Industry:Hazard Analysis and Risk-Based Preventive Controls for Human Food
			Docket Number: FDA-2016-D-2343
			2016/08Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
			Docket Number: FDA-2011-N-0179
			2016/06Draft 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
			2015/07Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide
			Docket Number: FDA-2013-N-1421
			2014/04Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
			Docket Number: FDA-2011-D-0674
			2014/04Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide
			Docket Number: FDA-2011-D-0643
			2013/03SUPERCEDED: 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*
			2012/12Guidance 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
			2012/02Guidance 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*
			2011/06Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues
			Docket Number: FDA-2011-D-0376
			2016/08Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance
			Docket Number: FDA- 2011-D-0287
			2011/04

                                                                                  Content current as of:
      01/30/2024
              
              
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