FSMA: Preventative Controls for Human Food Final Rule

In this presentation we discuss the Preventative Controls for Human Food rule and compliance dates which begin as soon as Sept 2016

Preventative Controls for Human Food

The FSMA Preventative Controls for Human Food rule is now finalThe final rule has been updated and clarified after consideration of public input

New definition of a farmSupply-chain program updatedCurrent Good Manufacturing Practices updated and clarified

Compliance dates now final.

Preventative Controls for Human Food

Rule requires a written food safety plan which includes

Hazard analysisPreventative controlsOversight and management of preventative controls

MonitoringCorrective actions and correctionsVerification

Preventative Controls for Human Food

Definition of a ‘farm’ has been expanded to cover two types of operations. Farms subject to Produce Safety Rule rather than preventative controls rule.

Primary Production Farm: An operation under one management which grows crops, harvests crops, or raises animals (including seafood)Secondary Activities Farm: An operation not located on the Primary Production Farm which harvests, packs, or holds raw agricultural commodities.

Preventative Controls for Human Food

Supply-chain program has been updated to be more flexible. Updates include:

Facilities required to have a risk based supply-chain program for certain hazards unless the facility is using a preventative controls plan for that hazardFacilities no longer required to have preventative controls for certain hazards which will be controlled by a subsequent entity.Separate compliance dates have been established so that facilities will not be required to comply with supply-chain provisions before its supplier.

Preventative Controls for Human Food

Current Good Manufacturing Practices updatedNonbinding provisions have either been removed or made bindingCGMPs now explicitly address allergen cross contact

Compliance DatesCountdown to compliance begins immediately

Very small businesses (less than $1 million per year in sales plus market value of unsold food): Three year deadlineBusinesses subject to Pasteurized Milk Ordinance: Three year deadlineSmall businesses (Fewer than 500 full-time employees): Two year deadlineAll other businesses: One year deadline

Compliance Dates: Supply Chain Program

Countdown to compliance begins immediatelyReceiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: Two year deadlineReceiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Two year deadline or six months after the supplier is required to comply with the applicable rule, whichever is laterReceiving facility is not a small or very small business and its supplier will not be subject to the human preventative controls rule or produce safety rule: 18 month deadline

Compliance Dates: Supply Chain Program

Countdown to compliance begins immediatelyReceiving facility is not a small or very small business and its supplier will be subject to the human preventative controls rule or produce safety rule: 6 months after supplier is required to comply with applicable rule.

Preparing for FSMA with GFSI Certification

Both FSSC 22000 and SQF Level 2 have had comparison studies that show how the Food Safety Management System can contribute to meeting the FSMA requirementsA facility that is Certified to one of these standards will be well on its way to complying with FSMA and can build any additional requirements into the Food Safety Management SystemThe FSSC 22000 or SQF system clearly outlines an effective way to implement the preventive controlsBy implementing one of these systems a company will also benefit from having a GFSI recognized Food Safety Management System Certification

How to PrepareThree Steps to FSMA Preventative Controls for Human Food compliance.

1.Determine the compliance deadline for your food facility2.Get certified to FSSC 22000 or SQF 3.Build any additional FSMA requirements directly into your

food safety management system (FSMS).4.Meet FSMA requirements and benefit from FSMS

Certification at the same time!

How to: Certification toFSSC 22000 or SQF

Visit www.22000-Tools.com and download your Quick Start Guide for a detailed outline of how to build your system and achieve certification.Use our Complete Training program to learn:

The requirements of the standardHow to do a Gap Analysis and plan your projectHow to document and build your system – including templatesHow to conduct Internal Audits