What's New in FSMA
2021
2020
- Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration
- FSMA Proposed Rule for Food Traceability
- FDA Announces FY2021 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program
- Efficacy Protocol for Reduction of Foodborne Bacteria in Preharvest Agricultural Water
- FDA Announces New Round of Funding to Support FSMA Education, Training and Technical Assistance
- 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
- 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
2019
- FSMA Proposed Rule on Laboratory Accreditation
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 14: Recall Plans
- FDA Launches the FDA-TRACK: Food Safety Dashboard to Track FSMA Progress
- FY2020 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program
- 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- Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Revised Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
- Public Meeting: Draft Guidance to Support Compliance with the Intentional Adulteration Rule
2018
- Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls
- Public Meetings on Draft Produce Safety Rule Guidance
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
- Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce
- Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration
- Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals
- Draft Guidance for Industry: Determining the Number of Employees for Purposes of the Small Businessâ Definition in Parts 117 and 507
- Voluntary Qualified Importer Program (VQIP) Applications Open
- 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: #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
- 2017 Annual Report to Congress on the Use of Mandatory Recall Authority
2017
- Guidance to Allow Co-Manufacturers Additional Time to Implement Certain Supply-Chain Program Requirements
- Guidances on Animal Food CGMPs and the FSMA âSolely Engagedâ Exemptions
- Compliance Guide for Small Businesses under FSMA Produce Safety Rule
- FDA Releases Sixth Chapter of Draft Guidance for the PC-Human Food Rule
- 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
- FSMA Inflation Adjusted Cut Offs
- 2016 Annual Report to Congress on the Use of Mandatory Recall Authority
- Third-Party Audits and FSMA
- 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
2016
- Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
- FDA's Strategy for FSMA Training: An Update
- 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
- Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA
- Informational Webinar on FSMA Draft Guidances for Current Good Manufacturing Practices Requirements for Food for Animals and the Human Food By-Products for Use as Animal Food
- Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)
- Informational Webinar on Preventive Controls Hazard Analysis and Risk-Based Draft Guidance
- FDA FSMA Regional Outreach Meetings Report
- 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
- Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017
- FSMA Final Rule: Amendments to Registration of Food Facilities
- FSMA Webinar: Final Rule under FSMA to Update Food Facility Registration
- Public Meetings: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs
- Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
- Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
- Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)
- Report on the 2015 Food Processing Sector Study
- Webinar on the Final Rule on Sanitary Transportation of Human and Animal Food
- Final Rule on Sanitary Transportation of Human and Animal Food
- Public Meeting: Prevention-Oriented Import System Regulations and Implementation
- FSMA Final Rule: Amendments to Registration of Food Facilities
- Annual Report to Congress on the Use of Mandatory Recall Authority - 2015
- Draft Guidance for Industry: Human Food By-Products For Use As Animal Food
2015
- FSMA Final Rule on Accredited Third-Party Certification
- FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- FSMA Final Rule on Produce Safety
- Environmental Impact Statement (EIS) for the FSMA Proposed Rule for Produce Safety
- FSMA Webinar Series: Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third Party Auditors
- Public Meeting: Preventive Controls for Human and Animal Food Final Rules
- Webinar Series: Preventive Controls for Human and Animal Food Final Rules
- Final Rule for Preventive Controls for Human Food
- Final Rule for Preventive Controls for Animal Food
- Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016
- Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
- Proposed Rule: User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
- Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program
- Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls
- Report to Congress on the National Agriculture and Food Defense Strategy (NAFDS) - 2015
- Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards
- Proposed Rule: Amendments to Registration of Food Facilities
- 2014 Annual Report to Congress on the Use of Mandatory Recall Authority
- Public Meeting: Environmental Impact Statement for the Proposed Rule Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Draft Environmental Impact Statement (EIS) for the FSMA Proposed Rule for Produce Safety
2013 - 2014
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition)
- Public Meeting: Supplemental Notices of Proposed Rulemaking
- Proposed Supplemental Rule for Produce Safety
- Proposed Supplemental Rule for Preventive Controls for Human Food
- Proposed Supplemental Rule for Preventive Controls for Animal Food
- Proposed Supplemental Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2015
- Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
- Public Meeting: Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
- 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,
- Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
- Public Meeting: Proposed Rule on Sanitary Transportation of Human and Animal Food â 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
- Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA
- FSMA Proposed Rule on Sanitary Transportation of Human and Animal Food
- Annual Report to Congress on the Use of Mandatory Recall Authority - 2013
- Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
- 2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices
- Biennial Report to Congress on the Food Emergency Response Network - 2013
- 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
- Proposed Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
- Information for Foreign Governments: Frequently Asked Questions on Systems Recognition
- 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
- Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates, FY 2014
- Proposed Rule: Accreditation of Third-party Auditors
- Proposed Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- Final Rule: Information Required in Prior Notice of Imported Food
- Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA)
- Guidance for FDA Staff: Draft CPG Sec 100 250 Food Facility Registration - Human and Animal Food
- 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
- Pilot Projects for Improving Product Tracing along the Food Supply System - Final Report
- 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
- Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption; Final Rule
- Proposed Rule for Produce: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Proposed Rule for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
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
- 2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices
- Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories
- Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2013
- Public meeting: International Capacity Building with Respect to Food Safety
- 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)
- Report to Congress on the FDA Foreign Offices
- Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug,
2011
- Guidance for Industry: What You Need to Know About Administrative Detention of Foods
- 2011 Biennial Report to Congress on the Food Emergency Response Network
- Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
- Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments and Information
- Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012
- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
- FSMA Smuggled Food Strategy
- Public Meeting: Focus on Inspections and Compliance Provisions
- Preventive Controls for Registered Human Food and Animal Food/Feed Facilities
- Administrative Detention of Food Interim Final Rule
- 2011 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices
- Fish and Fishery Products Hazards and Controls Guidance
- Prior Notice Interim Final Rule