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
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Draft Guidance for Industry: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Draft Guidance for Industry: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, 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Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods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Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (7th Edition)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