FDA Food Safety Modernization Act

 

• Guidance for Industry: Determination of Status as a Qualified Facility (September 2018)
  • Docket Number: FDA-2016-D-1164 

 

• Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)  (August 2018)
  • Docket Number: FDA-2012-D-1002 

 

• Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration (August 2018)
  • Docket Number: FDA-2012-D-1002

 

• Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (June 2018)
  • Docket Number: FDA-2018-D-1861

 

• Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (June 2018)
  • Docket Number: FDA-2018-D-1398

 

• Guidance 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 (May 2018)
  • Docket Number: FDA-2018-D-1378

 

• Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide   (May 2018)
  • Docket Number: FDA-2018-D-1468

 

• Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation (March 2018)
  • Docket Number: FDA-2011-N-0143

 

• Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals (March 2018)
  • Docket Number: FDA-2018-D-0721

 

• Draft Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (March 2018)
  • Docket Number: FDA-2018-D-0671

 

• Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (January 2018)
  • Docket Number: FDA-2017-D-5225

 

• Guidance 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 (January 2018)
  • Docket Number: FDA-2011-N-0143

 

• Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities (January 2018)
  • Docket Number: FDA-2017-D-6592

 

• Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR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 (January 2018)
  • Docket Number: FDA-2017-D-0397

 

• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food  (January 2018)
  • Docket Number: FDA-2016-D-2343 

 

• Draft Guidance for Industry: #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (January 2018)
  • Docket Number: FDA-2018-D-0388

 

• 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 (January 2018)
  • Docket Number: FDA-2017-N-6908

 

• Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government (December 2017)
  • Docket Number: FDA-2017-D-6528

 

• Guidance for Industry: Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide (November 2017)
  • Docket Number: FDA-2013-N-0013

 

• Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food (November 2017)
  • Docket Number: FDA-2017-D-5996

 

• Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (October 2017)
  • Docket Number: FDA-2017-D-6133

 

• Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals (October 2017)
  • Docket Number: FDA-2016-D-1229

 

• Guidance 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 (September 2017)
  • Docket Number: FDA-2011-N-0921

 

• Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule (August 2017)
  • Docket Number: FDA-2013-N-0013

 

• Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (August 2017)
  • Docket Number: FDA-2017-D-3716

 

• Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (August 2017)
  • Docket Number: FDA-2017-D-3716

 

• Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (August 2017)
  • Docket Number: FDA-2017-D-3716

 

• Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide (August 2017)
  • Docket Number: FDA-2013-N-1425

 

• Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation (March 2017)
  • Docket Number: FDA-2011-N-0143

 

• Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations (January 2017)
  • Docket Number: FDA-2017-D-0175

 

• Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (January 2017)
  • Docket Number: FDA-2008-D-0096

 

• Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (December 2016)
  • Docket Number: FDA-2011-N-0146 

 

• Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (December 2016)
  • Docket Number: FDA-2011-N-0146 

 

• Guidance for Industry: FDA's Voluntary Qualified Importer Program (November 2016)
  • Docket Number: FDA-2011-N-0144

 

• 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 (October 2016)
  • Docket Number: FDA-2011-N-092

 

• Guidance for Industry: Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (October 2016)
  • Docket Number: FDA-2011-N-0922

 

• Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (October 2016)
  • Docket Number: FDA-2016-D-2841

 

• Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) (September 2016)
  • Docket Number: FDA-2012-D-0585

 

• Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues  (August 2016)
  • Docket Number: FDA-2011-D-0376

 

• Draft Guidance for Industry: Human Food By-Products for Use as Animal Food (August 2016)
  • Docket Number: FDA-2016-D-1220  

 

• Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (August 2016)
  • Docket Number: FDA-2016-D-2373 

 

• Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) (June 2016) 
  • Docket Number: FDA-2011-N-0179

 

• Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls (May 2015)
  • Docket Number: FDA-2015-D-0138

 

• Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide (April 2014)
  • Docket Number: FDA-2013-N-1421

 

• Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (April 2014)
  • Docket Number: FDA-2011-D-0674

 

• Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide (March 2013)
  • Docket Number: FDA-2011-D-0643

 

• 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 2012)  
  • Docket Number: FDA-2011-D-0598

 

• Guidance for Industry: Enforcement Policy Concerning Certain Prior Notice Requirements(June 2011)

 

• Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance -- Fourth Edition (April 2011)
  • Docket Number: FDA- 2011-D-0287

 

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For more information, please contact the Guide Authors, Jackie Schweichler, Education Programs Coordinator, and Mary Webber, Research Assistant, at The Center for Agricultural and Shale Law.

Phone: (814) 865-4249 

Email: jks251@psu.edu

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The Center for Agricultural and Shale Law

Penn State Law

The Pennsylvania State University

329 Innovation Blvd., Suite 118

University Park, PA 16803

Phone: (814) 865-4290

Fax: (814) 865-3851