August 22, Jeffrey Barach, Ph.D. BARACH ENTERPRISES LLC

Transcription

1 August 22, 2013 Jeffrey Barach, Ph.D.

2 FSMA Background FSMA Current Status What s in a Food Safety Plan? CPG Companies Getting Prepared Packing/ Processing Companies- Being Proactive Q&A

3 Today Preventive Controls Human Food Produce Safety FSVP 3 rd Party Accreditation Traceability Mandatory Recalls Records Access Tomorrow Preventive Controls Animals & Pets VQIP Food Defense

4 Key Provisions Reaffirms Industry s Role in Food Safety Prevention vs. Reaction Risk-based Decisions Summary of Requirements Conduct a Hazard Analysis and Assign Risk-based Preventive Controls Develop a Written Food Safety Plan Follow Updated cgmps (Part 110 -> Part 117) Compliance Based on Company Size (1-3 years)

5 FSVP ( Foreign Supplier Verification Program) Compliance Check Hazard Analysis Risk Based Verification U.S. Standards (Several Options) Recordkeeping 3 rd Party Accreditation Program Concern is Quality, Objectivity of Foreign Audits FSMA Directs FDA to Establish a Program Including Certification of 3 rd Party Auditors Transparency and Recordkeeping

6 Action Required of FDA All Proposed Rules: PCs Food & Feed Produce Safety FSVP 3 rd Party Accred. Sanitary Transport Food Defense Close Comment Period All Final Regulations November 30, 2013 March 31, 2014 US District Court/ Northern CA CFS & CEH vs. FDA, June 2013 June 30, 2015

7 FSMA is 85% HACCP- We Know HACCP! First Rules are Proposed Rules and/or Draft Guidance Lengthy Comment Period (Months to a Year) Several Months for FDA to Respond to Comments 1 st Set of Final Rules and Guidance will be Published (mid 2014?) Implementation will Continue for Many Months Compliance-Will be Years (mid 2015 to 2017?)

8 10% 5% 5% cgmps - "allows HACCP to work" 30% HACCP- CCPs for Process Control Supply Chain - Imports 55% Food Defense

9 Covers 3 types of potential food safety hazards: Biological Chemical Physical Hazards may be naturally occurring in food, contributed by environment, or generated by a mistake during processing And FSMA adds Radiological hazards

10 Seafood, Juice (FDA) Meat & Poultry (USDA) Domestic & Foreign Human Foods & Animal Foods (FDA)

11 Hazard Analysis Defines: Hazards and Preventive Controls Company ABC s: FSVP Allergen Hazard Controls Parameters & Limits Records Process Controls (CCPS) Recall Plan Verification Monitoring Corrective Actions Sanitation Hazard Controls Company ABC s: Food Safety Plan Barach Enterprises LLC GRAPHIC by General Controls: Prerequisite Type Programs GMPs, SSOP, Supplier Controls, Food Defense and Others Foundational Food Safety Programs (SOPs)

12 Ingredients Product Properties (Risk) Packaging Water Labeling Air/ Environment People Finished Product Processing & Controls Equipment Design & Cleaning

13 Update Food Safety and Food Defense Plans - Hazard analysis - Preventive controls - Verification, including testing Update Supply Chain Management Programs - Domestic - Foreign Review Records Maintenance & Access Procedures - Routine - Under Bioterrorism Act

14 Being Proactive 1. Identify Your FSMA Key Contact Person (On-line HACCP Course?) 2. Identify the Issues and Define a Supporting Role to Assist CPG Companies 3. Outreach to Customers to Offer Help During Implementation and Compliance

15 Sanitary Equipment Design and Construction Sanitation Practices Allergen Management Environmental Monitoring Temperature Monitoring Validation Scientific Support & In-plant Validation Employee Training Records and Traceability

16 Minimize Surface Area to Clean Parts and Assemblies Easy to Access and Inspect Disassembly Can be Completed by Hand or With Simple Tools Cleaning and Sanitizing Procedures Can be Repeated by All Responsible Employees

17 If you can t see it you can t clean it! Provided by Triangle Package Machinery Co.

18 Find the Sanitary Design Problems 1) 4-Bolt Ball Valve: Difficult to Clean and Disassemble 2) Capped Ferrule: Provides a Dead-end 3) 1 Drain Line is Dead-end Equipment Photos by Tom Fishlove, General Mills-Sanitation Center of Excellence Pack Expo 2012

19 Example of Equipment with Tool-Less Disassembly -- No Need to Use Tools that May be Misplaced or Lost

20 Learn About HACCP Engage CPG Companies and Discuss Mutual Opportunities to Reduce Risk Focus on Sanitary Design and Process Validation The Window of Opportunity is Now, Don t Wait

21 Questions? Contact: