What's New in FSMA
2024
- Final Rule: Pre-Harvest Agricultural Water
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
2023
- 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- Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food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 Offs
2022
- 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- Draft Guidance for Industry: The Accredited Third-Party Certification Program: Questions and Answers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 Offs
2021
- 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 Offs
2020
- 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 Offs
2019
- 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 Offs
2018
- 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 Offs
2017
- 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 2018
2016
- 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 2017
2015
- 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 2016
2013 - 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 2015
2012
- 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 2013
2011
- 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