Preventive Control Rule – 21 Code of Federal Regulations Part 117

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

Is your company subject to thenew Preventive Control Rule?

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

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

DSHS Foods Group has put togethera flow diagram to assist companies in determining whether the facility may besubject to the rule. 

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

FDA has an excellent PreventiveControl website with resources for industry. 

Main Preventive Control Website


Upcoming Training


Texas Department of State Health Services (DSHS) will be hosting a FSPCA Preventive Controls for Human Food course April 23-25, 2019 in Denton, Texas at the University of North Texas campus University Gateway Center, 801 N Texas Blvd, Denton, TX 76201.

The course begins at 8:30 AM on Tuesday April 23rd and ends at 5:00 PM Thursday April 25th.
The cost of the course is $50. To register and pay certificate fee for the course click the link below:
https://lms.ifpti.org/Learn/ShoppingCart/Cart?CartsessionIds=237380ad-edd7-45fc-ad78-d2630585b2dd#/cart 

You can purchase the course book here: http://bookstorefspca.ifpti.org/index.php/course-materials.html

For more information, please email Davonna.Koebrick@dshs.texas.gov.


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Draft Guidance for Industry:Hazard Analysis and Risk-Based Preventive Controls for Human Food   

Draft Guidance for Industry:Classification of Activities as Harvesting, Packing, Holding, orManufacturing/Processing for Farms and Facilities

Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods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Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (7th Edition)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: SeafoodHACCP and the FDA Food Safety Modernization Act - New! 

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

Guidance for Industry: Low-AcidFoods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDAFood Safety Modernization Act - New! 

Guidance for Industry: Application of the Foreign Supplier Verification ProgramRegulation 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 ofFood for Humans and Animals  - New!  

Guidance for Industry: Foreign Supplier Verification Programs for Importers ofFood 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 ProgramRegulation to Importers of Grain Raw Agricultural Commodities  - New! 

Draft Guidance for Industry: Considerations for Determining Whether a Measure Providesthe Same Level of Public Health Protection as the Corresponding Requirement in21 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 forHuman Food; Chapter 15: Supply-Chain Program for Human Food Products  - New! 

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

Guidance for Industry: Policy Regarding Certain Entities Subject to the CurrentGood Manufacturing Practice and Preventive Controls, Produce Safety, and/orForeign Supplier Verification Programs   - New! 

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

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

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

Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts117 and 507  - New! 



FSMA Webinar:  Preventive Controls Hazard Analysis andRisk-Based Draft Guidance

FSMA Webinar Series:  Preventive Controls for Human and Animal FoodFinal Rules