What's New in FSMA
Actions implemented under the FSMA.
2017
2016
Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised
December 2016FDA’s Strategy for FSMA Training: An Update
December 2016FDA Finalizes FSMA Third-Party Certification User Fee Program
December 2016Guidance for Industry and FDA Staff:Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
December 2016Guidance for Industry: FDA's Voluntary Qualified Importer Program
November 2016Guidance 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
October 2016- Guidance for Industry: Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PDF - 238KB)
October 2106 Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA
October 2016What to Expect Now that the First Big FSMA Compliance Dates Are Here
October 2016Informational 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
September 2016Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)
September 2016What to Expect Now that the First Big FSMA Compliance Dates Are Here
September 2016FDA Provides $21.8 Million to States for Produce Safety
September 2016FSMA Webinar: Preventive Controls Hazard Analysis and Risk-Based Draft Guidance
September 2016FDA FSMA Regional Outreach Meetings Report (PDF - 406KB)
September 2016- Draft Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals (PDF - 251KB)
August 2016 Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities
August 2016Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
August 2016- Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017
August 2016 FSMA Final Rule: Amendments to Registration of Food Facilities
July 13, 2016FSMA Webinar: Final Rule under FSMA to Update Food Facility Registration
July 13, 2016- FSMA Public Meetings: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs
June 2016 Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
June 2016- Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
May 26, 2016 Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)
May 13, 2016Report on the 2015 Food Processing Sector Study
April 2016- Webinar on the Final Rule on Sanitary Transportation of Human and Animal Food
April 25, 2016 - Final Rule on Sanitary Transportation of Human and Animal Food
April 2016 - Public Meeting: FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation
March 21, 2016 FDA Seeks Public Comments, Data and Information on Assessing the Risk of Raw Manure as Fertilizer
March 3, 2016FSMA Final Rule: Amendments to Registration of Food Facilities
July 13, 2016Annual Report to Congress on the Use of Mandatory Recall Authority - 2015
February 2016- President’s FY 2017 Budget Request: Key Investments for Implementing the FDA Food Safety Modernization Act (FSMA)
February 2016 - Draft Guidance for Industry: Human Food By-Products For Use As Animal Food (PDF - 146KB)
August 2016
2015
- Clarification of Compliance Date for Certain Food Establishments for the Final Rule for Preventive Controls for Human Food
November 17, 2015 FSMA Final Rule on Accredited Third-Party Certification
November 13, 2015FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
November 13, 2015FSMA Final Rule on Produce Safety
November 13, 2015Environmental Impact Statement (EIS) for the FSMA Final Rule for Produce Safety
November 13, 2015FSMA Webinar Series: Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third Party Auditors
November 2015- Public Meeting: Preventive Controls for Human and Animal Food Final Rules
October 20, 2015 Food Safety in Today’s Global Food System: An FDA Perspective [ARCHIVED]
September 2015- Webinar Series: Preventive Controls for Human and Animal Food Final Rules
September 2015 - Final Rule for Preventive Controls for Human Food
September 2015 - Final Rule for Preventive Controls for Animal Food
September 2015 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016
July 2015 Guidance for Industry and FDA Staff:Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
July 2015- Proposed Rule: User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
July 2015 Guidance for Industry: FDA's Voluntary Qualified Importer Program
June 2015Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls
May 6, 2015Report to Congress on the National Agriculture and Food Defense Strategy (NAFDS) - 2015
April 2015- Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards
April 23, 2015 Influencing Outcomes in the Global Food System: FDA’s Evolving and Expanding Food Safety Role [ARCHIVED]
April 20, 2015- Proposed Rule: Amendments to Registration of Food Facilities
April 8, 2015 - 2014 Annual Report to Congress on the Use of Mandatory Recall Authority
February 2015 - Public Meeting: Environmental Impact Statement for the Proposed Rule Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
February 10, 2015 President’s FY 2017 Budget Request: Key Investments for Implementing the FDA Food Safety Modernization Act (FSMA)
February 2, 2015- Draft Environmental Impact Statement (EIS) for the FSMA Proposed Rule for Produce Safety
January 12, 2015
2013 - 2014
What Is FDA Doing to Promote the Safe Use of Manure and Compost on Crops? Questions and Answers with Michael Mahovic [ARCHIVED]
December 8, 2014Strategic Approach to Safe Use of Biological Soil Amendments [ARCHIVED]
December 8, 2014Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised
November 2014- Public Meeting: Supplemental Notices of Proposed Rulemaking [ARCHIVED]
November 13, 2014 - Speech: Food Safety in a Global Environment - Based on a Common Culture of Prevention and Verification [ARCHIVED]
November 5, 2014 - Proposed Supplemental Rule for Produce Safety
September 2014 - Proposed Supplemental Rule for Preventive Controls for Human Food
September 2014 - Proposed Supplemental Rule for Preventive Controls for Animal Food
September 2014 - Proposed Supplemental Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
September 2014 Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2015
August 2014Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
May 2, 2014- Public Meeting: Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption [ARCHIVED]
April 4, 2014 Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
April 3, 2014Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide
April 3, 2014Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
April 3, 2014Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
March 2014Update on Proposed Rules under the FDA Food Safety Modernization Act (March 19, 2014 ) [ARCHIVED]
March 19, 2014- Public Meeting: Proposed Rule on Sanitary Transportation of Human and Animal Food – College Park, MD [ARCHIVED]
March 20, 2014 - Public Meeting: Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration - Anaheim, CA [ARCHIVED]
March 13, 2014 - Public Meeting: Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration - Chicago, IL [ARCHIVED]
February 27, 2014 - Public Meeting: Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration – College Park, MD [ARCHIVED]
February 20, 2014 Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA
February 3, 2014FSMA Final Rule on Sanitary Transportation of Human and Animal Food
January 31, 2014Annual Report to Congress on the Use of Mandatory Recall Authority - 2013 [ARCHIVED]
January 28, 2014- Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
December 20, 2013 - Public Meeting: Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – Sacramento, CA [ARCHIVED]
December 6, 2013 2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices [ARCHIVED]
November 2013Biennial Report to Congress on the Food Emergency Response Network - 2013
November 2013- Public Meeting: Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - Chicago, IL [ARCHIVED]
November 25, 2013 - Public Meeting: Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - College Park, MD [ARCHIVED]
November 21, 2013 - Proposed Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
October 25, 2013 - FSMA Public Meeting: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Long Beach, CA [ARCHIVED]
October 22-23, 2013 - FSMA Public Meeting: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Miami, FL [ARCHIVED]
October 10-11, 2013 - FSMA Public Meeting: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Washington, DC [ARCHIVED]
September 19-20, 2013 FDA to Prepare Environmental Impact Statement on Proposed Produce Rule
August 16, 2013- Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates, FY 2014
August 2013 - Proposed Rule: Accreditation of Third-party Auditors
July 26, 2013 - Proposed Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
July 26, 2013 Final Rule: Information Required in Prior Notice of Imported Food
May 30, 2013- Report to Congress: Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA) [ARCHIVED]
May 2013 - FDA Progress Report on Implementing the Food Safety Modernization Act: January - March 2013 [ARCHIVED]
April 24, 2013 Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types [ARCHIVED]
April 2013- Guidance for FDA Staff: Draft CPG Sec 100 250 Food Facility Registration - Human and Animal Food (PDF - 47KB)
April 2013 Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide
March 2013Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF - 5.6MB)
March 4, 2013FDA's International Food Safety Capacity-Building Plan (PDF - 6.1MB)
February 28, 2013- FSPublic Meeting: Proposed Rules for Preventive Controls in Human Food and Produce Safety Standards; Portland, OR [ARCHIVED]
Meeting to be held on March 27-28, 2013 - FSMA Public Meeting: Proposed Rules for Preventive Controls in Human Food and Produce Safety Standards; Chicago, IL [ARCHIVED]
Meeting to be held on March 11-12, 2013 - FMSA Public Meeting: Proposed Rules for Preventive Controls in Human Food and Produce Safety Standards; Washington DC [ARCHIVED]
Meeting to be held on February 28 - March 1, 2013 Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption; Final Rule
February 2013- Proposed Rule for Produce: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
January 4, 2013 - Proposed Rule for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
January 4, 2013
2012
- FDA Progress Report on Implementing the Food Safety Modernization Act: October - December 2012 [ARCHIVED]
December 2012 Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide
December 2012Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised
December 2012Food Safety and Consumer Confidence in the Global Food System [ARCHIVED]
November 7, 2012Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)
October 2012- FDA Progress Report on Implementing the Food Safety Modernization Act: July - September 2012 [ARCHIVED]
October 2012 Progress on FSMA, Changes within the FDA Foods Program, and on Partnerships [ARCHIVED]
September 11, 20122012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices [ARCHIVED]
August 2012- Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2013
July 2012 - April - June 2012 FSMA Progress Reports [ARCHIVED]
July 1, 2012 - 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
June 2012 Improving Food Safety and Defense Capacity of State and Local Level, Review of State and Local Capacities
May 2012Role of the Food Safety Modernization Act in Ensuring the Safety of Pet Food [ARCHIVED]
April 4, 2012- FDA Progress Report on Implementing the Food Safety Modernization Act: January – March 2012 [ARCHIVED]
April 3, 2012 Ensuring Produce Safety in a Global Food System [ARCHIVED]
March 22, 2012Report to Congress on the FDA Foreign Offices [ARCHIVED]
February 2012- Interim Final Rule: Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
February 2012 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)
February 2012Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
February 2012Food Safety Collaboration in a Global Food System [ARCHIVED]
February 16, 2012FSMA One-Year Progress Report [ARCHIVED]
January 4, 2012- FDA Progress Report on Implementing the Food Safety Modernization Act: October - December 2011 [ARCHIVED]
January 4, 2012
September - December 2011
Implementation of the U.S. Food Safety Modernization Act: Building a Partnership for Prevention [ARCHIVED]
November 2, 2011- Preventive Controls for Registered Human Food and Animal Food/Feed Facilities Reopening of Comment Period
November 1, 2011 - FDA Progress Report on Implementing the Food Safety Modernization Act: August – September 2011 [ARCHIVED]
October 31, 2011 - Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012 - Comment Period Extended
October 26, 2011 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business - Comment Period Extended
October 18, 2011 Remarks at the 34th Annual National Food Policy Conference
October 4, 2011SUPERCEDED Guidance for Industry: What You Need to Know About Administrative Detention of Foods [ARCHIVED]
October 20112011 Biennial Report to Congress on the Food Emergency Response Network (FERN) [ARCHIVED]
September 2011Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
September 2011
March - August 2011
- Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments and Information
August 1, 2011 - Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012
August 1, 2011 Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
July 2011FSMA 2013 Progress Reports [ARCHIVED]
July 5, 2011FSMA Smuggled Food Strategy (PDF - 35KB)
July 3, 2011FDA Food Safety Modernization Act: Focus on Inspections and Compliance Provisions; Public Meeting [ARCHIVED]
Public Meeting
June 6, 2011- Preventive Controls for Registered Human Food and Animal Food/Feed Facilities
May 23, 2011 Prevention and Food Safety: Two Lenses, Common Vision [ARCHIVED]
May 19, 2011- Administrative Detention of Food Interim Final Rule
May 5, 2011 - FDA Progress Report on Implementing the Food Safety Modernization Act: January – April 2011 [ARCHIVED]
May 1, 2011 2011 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices [ARCHIVED]
April 6, 2011Fish and Fishery Products Hazards and Controls Guidance - Fourth Edition
April 2011- Prior Notice Interim Final Rule
May 5, 2011