Where Innovation Meets Regulation Assembling A Food Safety Plan For Your Brewery
Mary Pellettieri Gary Nicholas President Owner/Founder Top Note Mixers Nicholas Brewing Projects
Learning Objectives
2 3 1 Food Safety Awareness Hazard Analysis Key Hazards • Allergens Recognize and Understand how to manage food safety apply a formal • Brewery by- hazards and risks process: products entering the human food • Developing new chain products • Adjunct • Introducing fermentables changes to existing • Non-alcoholic brands beverages
Components of Food Safety in Breweries
Core BEER IS FOOD • Traditionally hadn’t been Concepts viewed as such in legal and regulatory frameworks • Began changing in 2003 and was formalized in 2011 • FDA and state/local bodies have jurisdiction for food safety
Core MISCONCEPTIONS • “Beer is ‘safe’” Concepts • “The rules don’t apply to me” • “Our brewery isn’t big enough for this to matter”
Food Safety Modernization Regulatory Act (FSMA) 21 CFR Part 117 • The Act provides broad Structures exemptions for alcoholic beverages, but these are subject to specific conditions • Just because an exemption exists does not mean that the rules aren’t valid or useful as a Best Practice
Food Safety Modernization Regulatory Act (FSMA) 21 CFR Part 117 • Non-exempt Structures • Subpart B: Current Good Manufacturing Practices • Subpart F: Recordkeeping • Generally exempt but may apply • Subpart C: Hazard Analysis and Risk-Based Preventive Controls • Subpart G: Supply-Chain Program
Current Good Manufacturing Managing Practices • Foundational component of Risk both Food Safety and Beer Quality • Addresses food safety aspects for operations, equipment, processes, buildings and grounds, and personnel
Managing Regulatory management • Facility registration and Risk inspections • Formula submissions • TTB Ruling 2015-1 Attachment 1 • “Generally Recognized As Safe” status (GRAS)
Food Safety Microbiological • Pathogens: Often seen as not Hazards relevant because beer is “safe,” this assumption is based on classic, traditional brewing practices. • As innovation and new practices evolve, those assumptions need to be challenged and re-evaluated.
Food Safety Physical • Most common example Hazards involves glass packaging • Glass fragments • “Bird - swing” and other flaws • Also need to monitor for metal, plastics, and other foreign bodies
Food Safety Chemical • ALLERGENS Hazards • Corrosive and other hazardous chemicals • Non-food-grade materials • Pesticides and raw material hazards
2 3 1 Food Safety Awareness Hazard Analysis Key Hazards • Allergens Recognize and Understand how to manage food safety apply a formal • Brewery by- hazards and risks process: products entering the human food • Developing new chain products • Adjunct • Introducing fermentables changes to existing • Non-alcoholic brands beverages
Hazard Analysis Hazard Analysis and • Core concept: Identify hazards which could cause Preventive illness or injury to a consumer • Two pathways Controls • Raw materials, ingredients, or environment • Process steps inside the brewery
Hazard Analysis Best Practice Conditions and • Non-traditional ingredients • Non-malt-based alcoholic Preventive beverages Controls • Market requirements • Large grocery chains or others with supply-chain mandates
Hazard Analysis Mandatory Triggering Conditions and • Non-alcoholic beverages • By-products that enter the Preventive Human Food chain • Bakeries Controls • Pet food • Vitamins and supplements • Loss of FDA exemption
Hazard Analysis Hazard Analysis: Basic Steps and • List all raw materials and process steps Preventive • Assess whether hazards could exist Controls • If so, have they been controlled?
Hazard Analysis Preventive Controls: Four Categories and • Process controls • Food Allergen controls Preventive • Sanitation controls Controls • Supply Chain controls
Hazard Analysis Preventive Controls: Components and • Define critical limits/parameters specific to Preventive the control measure • Build a monitoring system Controls • Lay out all corrective actions and verification steps • Define roles, responsibilities, and accountability
• Brewers Association Food Safety Planning for Craft Brewers (upcoming) • Master Brewers Association of the Americas Food Safety Website Selected • Food Safety Preventive Controls Alliance Resources (FSPCA) • Food Safety Modernization Act (21 CFR Part 117) • FDA Food Code 2017
• Good Manufacturing Practices for Craft Brewers Brewers • https://www.brewersassociation.org/educational- publications/good-manufacturing-practices-for- Association craft-brewers/ • FDA Registration and FSMA Compliance Links Flowchart • https://www.brewersassociation.org/educational -publications/fda-registration-food-safety- modernization-act-fsma-compliance-flow-chart/
2 3 1 Food Safety Awareness Hazard Analysis Key Hazards • Allergens Recognize and Understand how to manage food safety apply a formal • Brewery by- hazards and risks process: products entering the human food • Developing new chain products • Adjunct • Introducing fermentables changes to existing • Non-alcoholic brands beverages
Case Study #1 Working with Major Allergens
Coconut Peanut Ingredients • Base Butter • Water, Malts, Hops, Yeast, CO 2 Stout • Adjuncts • Coconut flakes • Peanut butter powder • Cocoa nibs
Coconut Peanut Hazard Analysis • Microbiological Butter • None, assuming cGMP in place Stout • Chemical • YES: Allergens • Physical • None, assuming cGMP in place
Hazard Allergens • Coconut flakes Analysis • Technically classified as a tree nut by the FDA • Peanut butter powder
Coconut Preventive Controls: Food Peanut Allergen and Sanitation • Allergen handling and storage Butter • Allergen SSOPs and CIP procedures Stout • Allergen documentation and by-product management
Allergen Handling and Preventive Storage • Receiving Controls • Identify allergens at the dock • Clearly label as allergens • Storage • Physical separation • Clear communication • Dedicated allergen-only scoops and buckets
Allergen SSOPs and CIP Preventive procedures • Clearly define measures used Controls to prevent potential cross- contact • The goal is to protect NON- ALLERGEN products
Allergen SSOPs and CIP Preventive procedures • Extended CIP cycles on Controls vessels and packaging lines • Verification: Allergen swabs • Housekeeping/area cleaning after any processing or handling
Allergen Documentation and Preventive By-Product Management • All process logs are clearly Controls marked with an indication that an allergen is involved • Waste / Process streams are isolated • Yeast will not be harvested from this brand
Regulatory Is a TTB Formula required? • Exemptions per TTB Ruling Issues 2015-1 Attachment 1 • Coconut: YES • Cocoa nibs: YES • Peanut butter powder: NO • Answer: Formula is required
Allergen Labeling Regulatory Requirements • Alcoholic beverages are NOT Issues required to list FDA-defined major allergens • Allergens MAY be voluntarily listed in a specific format • “CONTAINS: Coconut, Peanuts”
Case Study #2 Working with Fruit
Kettle Sour w/ Guava Ingredients • Base and • Water, Malts, Hops, Yeast, LAB inoculation, CO 2 Strawberry • Fruit additions • Guava puree • Whole-fruit strawberries
Kettle Sour w/ Guava Hazard Analysis • Microbiological and • Potential (raw material) • Chemical Strawberry • None, assuming cGMP in place • Physical • Potential (process)
Hazard Raw Ingredient: Guava puree • Source: All The Fruits Inc. Analysis • Pasteurized product: YES • Pasteurization process is documented and is suited for target pathogens • Pesticide-free: YES • Hazard assessment: NEGATIVE
Raw Ingredient: Whole-fruit Hazard Strawberries • Source: Try N Pick Organic Analysis Farms • Pasteurized product: NO • Potential for pathogens • Pesticide-free: YES • Hazard assessment: POSITIVE
Hazard Process: Fruit Addition • Version 1: During active Analysis fermentation • Fermentable sugars will be consumed by yeast • Terminal gravity is confirmed • Hazard assessment: NEGATIVE
Hazard Process: Fruit Addition • Version 2: During transfer to Analysis BBT • Hazard assessment: POSITIVE • Fermentable sugars present in package • Potential for catastrophic package over-pressure
Kettle Sour w/ Guava Process Preventive Controls • Receiving and storage and procedures • Raw ingredient: Heat kill-step Strawberry • Process step: • Version 1: Not required • Version 2: Heat kill-step
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