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 In this section:

                Food Safety Modernization Act (FSMA)

Food Safety Modernization Act (FSMA)

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          What's New in FSMAFood Safety Modernization Act (FSMA) What's New in FSMA
  
  	
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Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food2023

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	Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption
	Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
	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
	Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
	Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation
	Report: 2022 Report on User Fees Assessed and Collected
	Report: 2022 Report on the Use of Mandatory Recall Authority
	Announcement: FY2024 User Fee Rates Under the Food Safety Modernization Act for the Voluntary Qualified Importer Program the Accredited Third-Party Certification Program
	Announcement: FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules
	FSMA Inflation Adjusted Cut Offs2022

Final Rule: Requirements for Additional Traceability Records for Certain Foods
	Guidance for Industry: CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
	Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting
	Draft Guidance for Industry: The Accredited Third-Party Certification Program: Questions and Answers
	Revised Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation
	Agricultural Water Assessment Builder
	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
	Revised Guidance for Industry: FDA's Voluntary Qualified Importer Program
	Revised Guidance for Industry and FDA Staff: Model Accreditation Standards for Third-Party Certification Body Accreditation for Food Safety Audits
	Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government
	Small Entity Compliance Guide: Laboratory Accreditation for Analyses of Foods - What You Need to Know
	Announcement: FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements
	Announcement: FDA-recognized Accreditation Bodies for the Laboratory Accreditation for Analyses of Foods (LAAF) Program
	Public Meetings: Proposed Changes to Agricultural Water Requirements in the Produce Safety Rule
	Webinar: The New Laboratory Accreditation for Analyses of Foods (LAAF) Program
	Report: 2021 Report on User Fees Assessed and Collected
	Report: 2021 Report on the Use of Mandatory Recall Authority
	Report: 2020 Report on User Fees Assessed and Collected
	Fees: FY2023 User Fee Rates for the Voluntary Qualified Importer Program and the Accredited Third-Party Certification Program
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2023
	FSMA Inflation Adjusted Cut Offs2021

Proposed Rule: Agricultural Water
	Final Rule: Laboratory Accreditation for Analyses of Foods (LAAF)
	Guidance for Industry: Juice HACCP and the Food Safety Modernization Act
	Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act
	Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the Food Safety Modernization Act
	Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period
	Report: 2020 Report on the Use of Mandatory Recall Authority
	Fees: FY2022 User Fee Rates for the Voluntary Qualified Importer Program and the Accredited Third-Party Certification Program
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022
	FSMA Inflation Adjusted Cut Offs2020

Efficacy Protocol for Reduction of Foodborne Bacteria in Preharvest Agricultural Water
	Announcement: New Round of Funding to Support FSMA Education, Training and Technical Assistance
	Proposed Rule: Food Traceability
	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*
	Guidance for Industry: Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency
	Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency
	Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration
	Report: 2019 Report on the Food Emergency Response Network
	Report: 2019 Report on the National Agriculture and Food Defense Strategy (NAFDS)
	Report: 2019 Report on the Use of Mandatory Recall Authority
	Report: 2019 Report on the Use of Mandatory Recall Authority
	Fees: FY2021 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2021
	FSMA Inflation Adjusted Cut Offs2019

FDA-TRACK: Food Safety Dashboard to Track FSMA Progress
	Proposed Rule: Laboratory Accreditation
	Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 14: Recall Plans
	Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507
	Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Revised Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
	Public Meeting: Draft Guidance to Support Compliance with the Intentional Adulteration Rule
	Report: 2018 Report on the Use of Mandatory Recall Authority
	Fees: FY2020 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program
	Fees: Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2020
	Fees: Third-Party Certification Program User Fee Rate for Fiscal Year 2020
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2020
	FSMA Inflation Adjusted Cut Offs2018

Public Meetings: Draft Produce Safety Rule Guidance
	Announcement: Voluntary Qualified Importer Program (VQIP) Applications Open
	Announcement: First Accreditation Body under Accredited Third-Party Certification Program Recognized
	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
	Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls
	Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
	Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals
	Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration
	Guidance for Industry: #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
	Draft Guidance for Industry: Determining the Number of Employees for Purposes of the "Small Business" Definition in Parts 117 and 507
	Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce
	Report: 2017 Report on Enhancing Tracking and Tracing of Food and Recordkeeping
	Report: 2017 Report on the Use of Mandatory Recall Authority
	Report: 2015/2017 Report on the Food Emergency Response Network
	Report: 2017 Report on the Use of Mandatory Recall Authority
	Fees: Third-Party Certification Program User Fee Rate for Fiscal Year 2019
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019
	FSMA Inflation Adjusted Cut Offs2017

Compliance Guide for Small Businesses under FSMA Produce Safety Rule
	Draft Guidance: Sixth Chapter of the PC-Human Food Rule Draft Guidance
	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
	Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods
	Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food
	Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals
	Guidance for Industry: Animal Food CGMPs and the FSMA 'Solely Engaged' Exemptions
	Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide
	Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule
	Guidance for Industry: Juice HACCP and the Food Safety Modernization Act
	Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act
	Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the Food Safety Modernization Act
	Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation
	Third-Party Audits and FSMA
	Report: 2016 Report on Use of Mandatory Recall Authority
	Fees: Third-Party Certification Program User Fee Rate for Fiscal Year 2018
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 20182016

Update: Strategy for FSMA Training
	Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration
	Final Rule: Amendments to Registration of Food Facilities
	Final Rule on Sanitary Transportation of Human and Animal Food
	Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
	Draft Guidance for Industry: Human Food By-Products for Use as Animal Food
	Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA
	Draft Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals
	Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities
	Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
	Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)
	Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
	Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
	Guidance for Industry: FDA's Voluntary Qualified Importer Program
	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
	Guidance for Industry: Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
	Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)
	Public Meetings: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs
	Public Meeting: Prevention-Oriented Import System Regulations and Implementation
	Webinar: Final Rule under FSMA to Update Food Facility Registration
	Webinar: Preventive Controls Hazard Analysis and Risk-Based Draft Guidance
	Webinar: Final Rule on Sanitary Transportation of Human and Animal Food
	Webinar: FSMA Draft Guidance for Current Good Manufacturing Practices Requirements for Food for Animals and the Human Food By-Products for Use as Animal Food
	Report: Report on Regional Outreach Meetings
	Report: 2015 Report on Use of Mandatory Recall Authority
	Report: 2015 Report on the National Agriculture and Food Defense Strategy (NAFDS)
	Report: 2015 Report on Food Processing Sector Study
	Report: 2015 Report on the Use of Mandatory Recall Authority
	Report: 2015 Biennial Report on the Food Safety and Food Defense Research Plan
	Fees: Third-Party Certification Program User Fee Rate for Fiscal Year 2017
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 20172015

Final Rule:  Accredited Third-Party Certification
	Final Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
	Final Rule: Produce Safety
	Final Rule: Preventive Controls for Human Food
	Final Rule: Preventive Controls for Animal Food
	Proposed Rule: User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
	Proposed Rule: Amendments to Registration of Food Facilities
	Draft Environmental Impact Statement (EIS): Proposed Rule for Produce Safety
	Environmental Impact Statement (EIS) on the Proposed Rule for Produce Safety
	Webinar Series: Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third-Party Auditors
	Webinar Series: Preventive Controls for Human and Animal Food Final Rules
	Public Meeting: Preventive Controls for Human and Animal Food Final Rules
	Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
	Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program
	Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls
	Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards
	Public Meeting: Environmental Impact Statement for the Proposed Rule Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Report: 2014 Report on the Use of Mandatory Recall Authority
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 20162013 - 2014

Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
	Information for Foreign Governments: Frequently Asked Questions on Systems Recognition
	Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
	Final Rule: Information Required in Prior Notice of Imported Food
	Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
	Proposed Rule: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
	Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Proposed Rule: Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
	Proposed Supplemental Rule: Produce Safety
	Proposed Rule: Sanitary Transportation of Human and Animal Food
	Proposed Supplemental Rule: Preventive Controls for Human Food
	Proposed Supplemental Rule: Preventive Controls for Animal Food
	Proposed Supplemental Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
	Proposed Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
	Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition)
	Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide
	Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug,
	Guidance for FDA Staff: Draft CPG Sec 100 250 Food Facility Registration - Human and Animal Food
	Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
	Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA
	Public Meeting: Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Public Meeting: Proposed Rule on Sanitary Transportation of Human and Animal Food - College Park, MD
	Public Meeting: Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration - Anaheim, CA
	Public Meeting: Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration - Chicago, IL
	Public Meeting: Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration - College Park, MD
	Public Meeting: Supplemental Notices of Proposed Rulemaking
	Public Meeting: Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - Sacramento, CA
	Public Meeting: Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - Chicago, IL
	Public Meeting: Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - College Park, MD
	Public Meeting: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Long Beach, CA
	Public Meeting: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Miami, FL
	Public Meeting: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Washington, DC
	Proposed Rule: Accreditation of Third-party Auditors
	Proposed Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
	Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA)
	Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types
	Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide
	FDA's International Food Safety Capacity-Building Plan
	Public Meeting: Proposed Rules for Preventive Controls in Human Food and Produce Safety Standards - Portland, OR
	Public Meeting: Proposed Rules for Preventive Controls in Human Food and Produce Safety Standards - Chicago, IL
	Public Meeting: Proposed Rules for Preventive Controls in Human Food and Produce Safety Standards- Washington DC
	2013 Building Domestic Capacity to Implement the FDA Food Safety Modernization Act
	2013 International Food Safety Capacity-Building Plan
	Report: Pilot Projects for Improving Product Tracing along the Food Supply System
	Report: 2013 Report on Use of Mandatory Recall Authority
	Report: 2013 Report on Food Facilities, Food Imports, and FDA Foreign Offices
	Report: 2013 Report on Food Emergency Response Network
	Report: 2013 Biennial Report on the Food Emergency Response Network
	Report: 2012 Report on FDA Foreign Offices
	Report: 2012 Report on Food Facilities, Food Imports, and FDA Foreign Offices
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2014
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 20152012

Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide
	Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition)
	Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories
	Responses to Letters from Industry Concerning FDA's Plans Regarding the Preventive Controls and Foreign Supplier Verification Provisions in Sections 103 and 301 of the FSMA
	Improving Food Safety and Defense Capacity of State and Local Level, Review of State and Local Capacities
	Interim Final Rule: Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
	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)
	Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug
	Report: 2011 Biennial Report on the Food Emergency Response Network
	Report: 011 Report on Food Facilities, Food Imports, and FDA Foreign Offices
	Report: 2011 Report on Food Emergency Response Network
	Fees: Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 20132011

Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
	Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance
	Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
	Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments and Information
	FSMA Smuggled Food Strategy
	Request for Information: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities
	Public Meeting: Focus on Inspections and Compliance Provisions
	Interim Final Rule: Administrative Detention of Food
	Interim Final Rule: Prior Notice
	Fees: Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012

                                                                                  Content current as of:
      01/30/2024
              
              
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			  Food Safety Modernization ActFood Safety Modernization Act (FSMA)

          
                        Frequently Asked Questions on FSMA
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