Alignment of FSSC with FSMA. Aldin Hilbrands, Technical Director

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1 Alignment of FSSC with FSMA Aldin Hilbrands, Technical Director

2 Food Safety Modernization Act (FSMA) Necessary update of GMPs and old legislation Move to be preventive rather than reactive Developed following some major incidences Months of consultation with private sector Series of 7 regulations Publication of Final Rules from Sept 2015

3 Rules and Dates of Compliance Final Rule Date of Issue Compliance Large Business Compliance Small Business CGMP and Preventive Controls for Human Food CGMP and Preventive Controls for Animal Feed Produce Safety Rule Foreign Supplier Verification Program 3rd Party Accreditation and Certification Sanitary Transportation of Human and Animal Food Food Defense / International Adulteration Sept 17th 2015 Sept 19th 2016 Sept 18th 2017 Sept 17th 2015 Sept 19th 2016 (cgmp) Sept 18th 2017 (PCs) Sept 18th 2017 (cgmp) Sept 17th 2018 (PCs) Nov 27th 2015 Jan 26th 2018 Jan 26th 2019 Nov 27th 2015 May 27th 2017 N/A Nov 27th 2015 Requirements into effect after FDA publishes Accreditation Standards April 6th 2016 April 6th 2017 April 6th 2018 May 27th 2016 July 26th 2019 July 26th 2020

4 PC for Human Food FSMA Food Safety Plan Subparts Established in 21 CFR Part 117 Subpart Title A. General Provisions B. Current Good Manufacturing Practice C. Hazard Analysis and Risk Based Preventive Controls D. Modified Requirements E. Withdrawal of a Qualified Facility Exemption F. Requirements Applying to Records G. Supply Chain Program

5 Current GMP and Hazard Analysis and Risk- Based Preventive Controls for Human Food Published Sept 2015 Implementation Sept 2016 US-Centric but with far reaching influences Focus on Prevention: Inspections, compliance and response Supply chain and Import Safety Enhanced Partnerships and Training

6 FSMA and FSSC Similarities Shared goals of food safety through preventive controls and flexible management system approach FSMA requires a Food Safety Plan Requires flexibility with accountability HARPC is modification of HACCP with PRP s Training is an important element Focus on the Supply Chain

7 HACCP versus FSMA FSP (HARPC) Element HACCP PLAN FSMA FOOD SAFETY PLAN Hazard Analysis Biological, Chemical and Physical Processes Chemical hazards include radiological hazards and consideration of economically motivated adulteration ( 21 CFR (b)(1)( ii )) Preventive Controls CCP's for processes Process CCP's & Controls at other points that are not CCP's ( 21 CFR (a)(2)) Parameter and Values Critical limits at CCP's Parameters and min/max values (equivalent to critical limits for process controls ) (21 CFR (c)(1)) Monitoring Required for CCP's Required as appropriate for preventive controls (21 CFR ) Corrective Actions and Corrections Verification including Validation Corrective actions For process controls Corrective actions or corrections as appropriate (21 CFR (a) Verification as appropriate for all preventive controls: Validation for all process controls: Supplier verification required when supplier controls a hazard ( 21 CFR , ) Records For process controls As appropriate for all preventive controls (21 CFR ) Recall Plan Not required in the Plan Required when a hazard requiring a preventive control is identified (21 CFR )

8 Gap analysis of FSSC versus FSMA Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food FSSC ISO versus PRP (ISO ) Additional requirements

9 General comparison FSSC vs FSMA FSSC required elements exceed the rule in several areas. Where it is not exceeding measure comparable to the Final Rule requirements. There are no elements of the FDA preventive control and cgmp requirements that are clearly just missing in FSSC that we could determine...

10 Detailed comparison FSMA vs FSSC Mapping of FSMA requirements against FSSC Provides a reference for industry and regulators Shows alignment and differences in the details Increased documentation Demand for the verification of suppliers Foreign Supplier Verification Program

11 FSMA FSP vs FSSC FSMS FSMA FOOD SAFETY PLAN FSSC Comments (b)(1)( ii )) Chemical hazards include radiological hazards and consideration of economically motivated adulteration ( 21 CFR (a)(2)) Process CCP's & Controls at other points that are not CCP's Comparable: ISO Comparable: ISO & Will include radiological and EA in FSSC version 4 FSSC refers to control measures that can be managed though operational PRP's or HACCP (21 CFR (c)(1)) Parameters and min/max values (equivalent to critical limits for process controls ) Comparable: ISO (21 CFR ) Required as appropriate for preventive controls Comparable: ISO (21 CFR (a) Corrective actions or corrections as appropriate Comparable: ISO ( 21 CFR , ) Verification as appropriate for all preventive controls: Validation for all process controls: Supplier verification required when supplier controls a hazard Comparable ISO (21 CFR ) As appropriate for all preventive controls Comparable ISO Additional details Verification by a PCQI within 90 days- Supplier verification: more detail required (21 CFR ) Required when a hazard requiring a preventive control is identified Comparable: ISO ISO Additional details re disposal may be needed

12 FSMA Guidance issued by FDA

13 Alignment of FSSC with FSMA Revision of Version 4 to add more requirements to the FSSC scheme A supplementary FSMA module could provide the detail required by the legislative standard Extend resources of FDA by providing: Evidence of supplier verification for FSVP Risk assessment of companies Evidence of overall compliance

14 Let s connect! Website info@fssc22000.com Phone LinkedIn Group FSSC 22000