Preventive Control Rule – 21 Code of Federal Regulations Part 117

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The Preventive Control Rule for Human food establishes requirements for facilities that manufacture, process, pack, or hold food for consumption.

Is your company subject to the new Preventive Control Rule?

The primary assessment for companies as to whether they are subject to the Preventive Control Rule is the requirement to register with FDA as a food facility, known as Registration of Food Facilities (http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm).

If your facility is required to register, the facility is subject to the Preventive Control Rules, unless the facility qualifies for an exemption listed within the actual rule.  

DSHS Foods Group has put together a flow diagram to assist companies in determining whether the facility may be subject to the rule. 

FDA’s New Preventive Control Rule (21 CFR Part 117) Who is Subject???  Who is Exempt???

FDA has an excellent Preventive Control website with resources for industry. 

Main Preventive Control Website



Food Safety Plan Builder - New!

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food   

Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities

Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide

Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (7th Edition)

Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act - New! 

Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act - New! 

Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act - New! 

Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals - New! 

Draft Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507  - New! 

Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals  - New!  

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  - New! 

Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities  - New! 

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  - New! 

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 15: Supply-Chain Program for Human Food Products  - New! 

Guidance for Industry: #245 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals  - New! 

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   - New! 

Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government  - New!  

Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food  - New! 

Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals  - New! 

Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  - New! 



FSMA Webinar:  Preventive Controls Hazard Analysis and Risk-Based Draft Guidance

FSMA Webinar Series:  Preventive Controls for Human and Animal Food Final Rules

 

Last updated March 28, 2018