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 final The final rule has been updated and clarified after consideration of public input New definition of a farm Supply-chain program updated Current 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 analysis Preventative controls Oversight and management of preventative controls Monitoring Corrective actions and corrections Verification

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 hazard Facilities 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 updated Nonbinding provisions have either been removed or made binding CGMPs now explicitly address allergen cross contact

Compliance Dates Countdown to compliance begins immediately Very small businesses (less than $1 million per year in sales plus market value of unsold food): Three year deadline Businesses subject to Pasteurized Milk Ordinance: Three year deadline Small businesses (Fewer than 500 full-time employees): Two year deadline All other businesses: One year deadline

Compliance Dates: Supply Chain Program Countdown to compliance begins immediately Receiving 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 deadline Receiving 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 later Receiving 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 immediately Receiving 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 and SQF Level 2 have had comparison studies that show how the Food Safety Management System can contribute to meeting the FSMA requirements A 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 System The FSSC or SQF system clearly outlines an effective way to implement the preventive controls By implementing one of these systems a company will also benefit from having a GFSI recognized Food Safety Management System Certification

How to Prepare Three Steps to FSMA Preventative Controls for Human Food compliance. 1. Determine the compliance deadline for your food facility 2. Get certified to FSSC 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 to FSSC or SQF Visit 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 standard How to do a Gap Analysis and plan your project How to document and build your system – including templates How to conduct Internal Audits