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Webinar 2014 Food Safety Modernization Act (FSMA) By: John B. Mueller 4
The Food Safety Modernization Act FSMA The most sweeping reform of our food safety laws in more than 70 years, was signed into law on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination of the food supply to preventing it. The law applies to human food as well as to food for animals, including pets. FDA.gov 5
Food Safety Modernization Act - FSMA 1938 Food, Drug, and Cosmetic Act 1906 Pure Food and Drug Act Source: David Fairfield - NGFA 6
Court-Established Deadlines Subject Produce Rule CGMPs and Preventive Controls - Human Food Foreign Supplier Verification Programs Accreditation of Third-Party Auditors CGMPs and Preventive Controls - Animal Feed Food Defense/ Intentional Adulteration Sanitary Transportation of Food/Feed Publishing Proposed Rule Published Jan. 16, 2013 Published Jan. 16, 2013 Published July 29, 2013 Published Oct. 29, 2013 Published Dec. 24, 2013 Published Feb. 5, 2014 Deadlines Close of Comment Period Publishing Final Rule Nov. 22, 2013 Oct. 31, 2015 Nov. 22, 2013 Aug. 30, 2015 Jan. 27, 2014 Oct. 31, 2015 March 31, 2014 Aug. 30, 2015 March 31, 2014 May 31, 2016 May 31, 2014 March 31, 2016
Food Safety Modernization Act - FSMA 8
Food Safety Modernization Act - FSMA What can we learn from the Food Industry? Sanitation / Quality Manager GMP HACCP Third Party Audits 3PA FDA 9
FSMA Components: Secretary of HHS FDA FSMA Proposed 507.3 defines "animal food" as food for animals other than man, and includes pet food, feed, and raw materials and ingredients. Food Rule Feed Rule 10
Food Safety Modernization Act - FSMA What are the Feed Rule, Exemption, Pro s & Con s for RAC s being Held? Con s No FDA Baseline for Feed Pro s Grain Industry Samples for Hazards Largest Feed Ingredient Controls for Safety and Quality Grain Not Cleaned No Historical Issues 11
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What are your CHOICES today? 1) Do Nothing Now. 2) Conform Current Processes & Programs. 3) Fully Comply. 14
Why CONFORM or COMPLY? 1) Not Exempt = Law. 2) Exempt but Buyer Requires. 3) Exempt Status Could Change. 15
CONFORM or COMPLY! What is next? Study Applicable Rule. Understand Terminology Designate a Qualified Person. Integrate Your Processes & Procedures Identify Gaps 16
The Law 38,931 Pest - 0 Mold - 0 Cleaning - 0 Sanitation - 3 Protection - 23 Homeland Security - 53 Safety - 155 Feed Rule 113,730 Pest - 58 Mold - 11 Cleaning - 121 Sanitation - 72 Protection - 33 Homeland Security - 1 Safety 481 FD&C - 390 17
Public Health Service Act Secretary of HHS FD&C Agricultural Import Securing the Borders of the US Secretary of Agriculture Packers and Stockyards Act United States Warehouse Act Agricultural Adjustment Act Poultry Products Inspection Act FDA Bio- Terrorism Act Import Statutes Codex Managing Ports of Entry Entry Inspection Activities Federal Meat Inspection Act USDA FSMA Export Issues International Programs Egg Products Inspection Act FGIS United States Grain Standards Act Ag Marketing Agreement Act Agricultural Marketing Act ATTTB Homeland Security Act DHS Secretary Homeland Security USDT Secretary of Treasury 18
Terms for Grain Raw Agricultural Commodities RAC s Raw Materials for Animal Feed Raw Ingredients Terms for Grain Facility Holding Held 19
Focus Current Good Manufacturing Practices - cgmp Hazard Analysis Risk Base Preventative Controls 20
Trained Person (cgmp) Competent supervisory personnel. Background of education or competent experience for clean and safe animal food. ID plant sanitation failures. ID food contamination. Trainer 21
Plant and Ground (cgmp) 22
Sanitation Design (cgmp) 23
Sanitation Design (cgmp) 24
Sanitary Operation (cgmp) Cleaning SOP s Training 25
Sanitary Operation (cgmp) Daily As Needed Weekly Monthly Quarterly Yearly Master Sanitation 26
Sanitary Operation (cgmp) Chemical Handling List what you use. Make an approved chemical list. Gather all SDS (EPA). Consider how these are stored. 27
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Sanitary Operation (cgmp) Pest Management In house v Hired. Documentation 29
Hazard Analysis and Rick Based Preventative Controls. 30
Sanitary Facilities and Controls (cgmp) Secure water source. Sewage Toilets Radiological Contamination 31
Equipment & Utensils (cgmp) Non-food Grade Lubricants Metal Fragments Brittle Plastic Wood Other Contaminants Picture: CBG.com 32
PROCESS Standard Unique PROCEDURES Mandatory Unique DOCUMENTED Evaluate Evaluate Evaluate Evaluate SOP SOP SOP SOP Train Train Train Train Validate Validate Validate Validate 33
Warehousing and Distribution (cgmp) Contamination Glass Fertilizer 34
Warehousing and Distribution Contamination 35
Hazard Analysis and Risk Based Preventative Control cgmps were more standard practices Hazard Analysis and Rick Based Preventative Controls identify gaps and fill them with situational and changing needs. Probe & Sample Dry / Cool Hold & Monitor Release / Transport 36
Hazard Analysis and Risk Based Preventative Controls Page 195 FDA uses the example, a facility holds shelled corn in bulk units for an extended time period until it is sold or mixed into an animal food may identify the potential for growth of aflatoxinproducting molds on the corn as a hazard reasonably likely to occur. As a process control to prevent such molds from growing on the corn during storage, the facility may elect to dry the corn to a The specific process moisture control content (e.g., would no more be than drying 15 percent) and prior the to placing the corn in storage. The process control would be drying and associated the associated parameter would be moisture be moisture level, with level, maximum value, or limit, being 15 percent. with maximum value, or limit, being 15 percent. 37
Food Safety Plan FSMA does not want to see a universal corporate Food Safety Plan. Must be site specific Each facilities food safety dynamic is like a finger print. 38
Hazard Analysis and Risk Based Preventative Controls The FOOD SAFETY PLAN Scientifically Sound University Studies USDA Reports Technically Sound Equipment Support Instrument Support 39
Hazard Identification Biological Chemical Physical Radiological Natural Toxins Pesticides Drug residues Decomposition Parasites Allergens Unapproved food and color additives Natural Hazards Unintentionally Introduced 40
Hazard Analysis and Risk Based Preventative Controls The Catch All Proposed 507.33(d)(10) would require that the hazard evaluation consider the effect of any relevant factors that might potentially affect the safety of the finished animal food. 41
Hazard Analysis and Risk Based Preventative Controls Probe & Sample Dry / Cool Hold & Monitor Release / Transport DOCUMENTED Hazards? Hazards? Hazards? Hazards? Prevention. Prevention. Prevention. Prevention. Monitor. Monitor. Monitor. Monitor. Verification / Validation Verification / Validation Verification / Validation Verification / Validation All Documented and Audit Ready. 42
Hazard Analysis & Risk Based Preventative Controls The Hazard Analysis as required. Preventive Controls as required. Recall Plan as required. Procedures, Frequency, and Monitoring. Corrective Action procedures. Verification procedures. Documented. 43
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Hazard Analysis and Risk Based Preventative Controls Food Safety Observations to comply with: Monitoring the plan for performance. Supply required Corrective Actions. And supply Verification of a well maintain food safety plan. 47
Hazard Analysis and Preventative Controls Monitoring, Corrective Action, Verification: Mock Audit Program Incorporate FSO. Include all departments. Write work orders on the spot. Audit readiness 48
Hazard Analysis and Risk Based Preventative Controls Monitor Do you have a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification. Sampling and Analysis Drying / Cooling Parameters Holding Maintaining Condition 49
Hazard Analysis and Risk Based Preventative Controls Annual Requirement or Supplier Audit - 3PA 50
Food Safety Modernization Act - FSMA What can we learn from the Food Industry? Third Party Program Auditing 3PA What was: A three day audit = two days in the plant looking and one day reviewing paperwork. What is: Two days on paperwork with one day in the plant. 51
What can we learn from the Food Industry? Peer High Water Mark Site specific interpretation. Industry specific interpretation. Peer interpretation. Auditor interpretation. Audit evolution 52
Who are your Allies and Assets? Federal Grain Inspection Service Pest Management Provider Organizations NGFA, GEAPS State Department of Agriculture Ag Universities 53
Summary Is doing nothing really an option? FSMA will change our industry. History is on our side lets show that the future is as well. 54
Not Exempt From Current Good Manufacturing Practices - cgmp Exempt From Hazard Analysis and Rick-Based Preventative Controls. 55
John B. Mueller 17338 Westfield Park Road Westfield, Indiana 46074 314 330-5336 (Cell) 855 377-3444 john@foodprotectionservices.net www.food ProtectionServices.net Member 56
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