Post on 26-May-2020
Where Innovation Meets Regulation
Assembling A Food Safety Plan For Your Brewery
Gary Nicholas
Owner/Founder
Nicholas Brewing Projects
Mary Pellettieri
President
Top Note Mixers
Learning Objectives
1
Recognize and manage food safety hazards and risks
Understand how to apply a formal process:
• Developing new products
• Introducing changes to existing brands
• Allergens
• Brewery by-products entering the human food chain
• Adjunct fermentables
• Non-alcoholic beverages
Food Safety Awareness Hazard Analysis Key Hazards
2 3
Components of Food Safety in
Breweries
Core Concepts
• Traditionally hadn’t been 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
BEER IS FOOD
Core Concepts
• “Beer is ‘safe’”
• “The rules don’t apply to me”
• “Our brewery isn’t big enough for this to matter”
MISCONCEPTIONS
Regulatory Structures
• The Act provides broad 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 Act (FSMA) 21 CFR Part 117
Regulatory Structures
• Non-exempt
• 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
Food Safety Modernization Act (FSMA) 21 CFR Part 117
Managing Risk
• Foundational component of both Food Safety and Beer Quality
• Addresses food safety aspects for operations, equipment, processes, buildings and grounds, and personnel
Current Good Manufacturing Practices
Managing Risk
• Facility registration and inspections
• Formula submissions
• TTB Ruling 2015-1 Attachment 1
• “Generally Recognized As Safe” status (GRAS)
Regulatory management
Food Safety Hazards
• Pathogens: Often seen as not 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.
Microbiological
Food Safety Hazards
• Most common example involves glass packaging
• Glass fragments
• “Bird-swing” and other flaws
• Also need to monitor for metal, plastics, and other foreign bodies
Physical
Food Safety Hazards
• ALLERGENS
• Corrosive and other hazardous chemicals
• Non-food-grade materials
• Pesticides and raw material hazards
Chemical
1
Recognize and manage food safety hazards and risks
Understand how to apply a formal process:
• Developing new products
• Introducing changes to existing brands
• Allergens
• Brewery by-products entering the human food chain
• Adjunct fermentables
• Non-alcoholic beverages
Food Safety Awareness Hazard Analysis Key Hazards
2 3
Hazard Analysis and Preventive Controls
• Core concept: Identify hazards which could cause illness or injury to a consumer
• Two pathways
• Raw materials, ingredients, or environment
• Process steps inside the brewery
Hazard Analysis
Hazard Analysis and Preventive Controls
• Non-traditional ingredients
• Non-malt-based alcoholic beverages
• Market requirements
• Large grocery chains or others with supply-chain mandates
Best Practice Conditions
Hazard Analysis and Preventive Controls
• Non-alcoholic beverages
• By-products that enter the Human Food chain
• Bakeries
• Pet food
• Vitamins and supplements
• Loss of FDA exemption
Mandatory Triggering Conditions
Hazard Analysis and Preventive Controls
• List all raw materials and process steps
• Assess whether hazards could exist
• If so, have they been controlled?
Hazard Analysis: Basic Steps
Hazard Analysis and Preventive Controls
• Process controls
• Food Allergen controls
• Sanitation controls
• Supply Chain controls
Preventive Controls:
Four Categories
Hazard Analysis and Preventive Controls
• Define critical limits/parameters specific to the control measure
• Build a monitoring system
• Lay out all corrective actions and verification steps
• Define roles, responsibilities, and accountability
Preventive Controls: Components
Selected Resources
• Brewers Association Food Safety Planning for Craft Brewers (upcoming)
• Master Brewers Association of the Americas Food Safety Website
• Food Safety Preventive Controls Alliance (FSPCA)
• Food Safety Modernization Act (21 CFR Part 117)
• FDA Food Code 2017
Brewers Association
Links
• Good Manufacturing Practices for Craft Brewers
• https://www.brewersassociation.org/educational-publications/good-manufacturing-practices-for-craft-brewers/
• FDA Registration and FSMA Compliance Flowchart
• https://www.brewersassociation.org/educational-publications/fda-registration-food-safety-modernization-act-fsma-compliance-flow-chart/
1
Recognize and manage food safety hazards and risks
Understand how to apply a formal process:
• Developing new products
• Introducing changes to existing brands
• Allergens
• Brewery by-products entering the human food chain
• Adjunct fermentables
• Non-alcoholic beverages
Food Safety Awareness Hazard Analysis Key Hazards
2 3
Case Study #1Working with Major Allergens
Coconut Peanut Butter Stout
• Base
• Water, Malts, Hops, Yeast, CO2
• Adjuncts
• Coconut flakes
• Peanut butter powder
• Cocoa nibs
Ingredients
Coconut Peanut Butter Stout
• Microbiological
• None, assuming cGMP in place
• Chemical
• YES: Allergens
• Physical
• None, assuming cGMP in place
Hazard Analysis
Hazard Analysis
• Coconut flakes
• Technically classified as a tree nut by the FDA
• Peanut butter powder
Allergens
Coconut Peanut Butter Stout
• Allergen handling and storage
• Allergen SSOPs and CIP procedures
• Allergen documentation and by-product management
Preventive Controls: Food Allergen and Sanitation
Preventive Controls
• Receiving• Identify allergens at the dock
• Clearly label as allergens
• Storage• Physical separation
• Clear communication
• Dedicated allergen-only scoops and buckets
Allergen Handling and Storage
Preventive Controls
• Clearly define measures used to prevent potential cross-contact
• The goal is to protect NON-ALLERGEN products
Allergen SSOPs and CIP procedures
Preventive Controls
• Extended CIP cycles on vessels and packaging lines
• Verification: Allergen swabs
• Housekeeping/area cleaning after any processing or handling
Allergen SSOPs and CIP procedures
Preventive Controls
• All process logs are clearly marked with an indication that an allergen is involved
• Waste / Process streams are isolated
• Yeast will not be harvested from this brand
Allergen Documentation and By-Product Management
Regulatory Issues
• Exemptions per TTB Ruling 2015-1 Attachment 1
• Coconut: YES
• Cocoa nibs: YES
• Peanut butter powder: NO
• Answer: Formula is required
Is a TTB Formula required?
Regulatory Issues
• Alcoholic beverages are NOT required to list FDA-defined major allergens
• Allergens MAY be voluntarily listed in a specific format
• “CONTAINS: Coconut, Peanuts”
Allergen Labeling Requirements
Case Study #2Working with Fruit
Kettle Sour w/ Guava and Strawberry
• Base
• Water, Malts, Hops, Yeast, LAB inoculation, CO2
• Fruit additions
• Guava puree
• Whole-fruit strawberries
Ingredients
Kettle Sour w/ Guava and Strawberry
• Microbiological• Potential (raw material)
• Chemical• None, assuming cGMP in
place
• Physical• Potential (process)
Hazard Analysis
Hazard Analysis
• Source: All The Fruits Inc.
• Pasteurized product: YES
• Pasteurization process is documented and is suited for target pathogens
• Pesticide-free: YES
• Hazard assessment: NEGATIVE
Raw Ingredient: Guava puree
Hazard Analysis
• Source: Try N Pick Organic Farms
• Pasteurized product: NO
• Potential for pathogens
• Pesticide-free: YES
• Hazard assessment: POSITIVE
Raw Ingredient: Whole-fruit Strawberries
Hazard Analysis
• Version 1: During active fermentation
• Fermentable sugars will be consumed by yeast
• Terminal gravity is confirmed
• Hazard assessment: NEGATIVE
Process: Fruit Addition
Hazard Analysis
• Version 2: During transfer to BBT
• Hazard assessment: POSITIVE
• Fermentable sugars present in package
• Potential for catastrophic package over-pressure
Process: Fruit Addition
Kettle Sour w/ Guava and Strawberry
• Receiving and storage procedures
• Raw ingredient: Heat kill-step
• Process step:
• Version 1: Not required
• Version 2: Heat kill-step
Process Preventive Controls
Preventive Controls
• Receiving: Containers will be inspected upon delivery• Matches the actual order?
• Seals and containers intact?
• No signs of expansion or damage?
• Storage: Fruit products will be stored cold until use
Receiving and Storage
Preventive Controls
• Strawberries will be heated in a secondary vessel to kill any pathogens
• Define temperature and time
• Document the process and attach to the batch logs
Raw Strawberries: Kill-Step
Preventive Controls
• Beer will be pasteurized pre-or post-packaging to eliminate any microbial activity
• Define temperature and time
• Document the process and attach to the batch logs
Process:
Kill-Step for Version 2
Regulatory Issues
• Exemptions per TTB Ruling 2015-1 Attachment 1
• Guava: NO
• Strawberries: YES
• Formula is required
Is a TTB Formula required?
Case Study #3Non-alcoholic Flavored Sparkling Water
Tamarind-Ginger Non-AlcoholicSoda
• Base
• Water
• CO2
• Flavor addition
• Tamarind extract
• Ginger extract
Ingredients
Tamarind-Ginger Non-AlcoholicSoda
• Microbiological
• Chemical
• Physical
Hazard Analysis - Discussion
Tamarind-Ginger Non-AlcoholicSparkling Water
• Microbiological
• Chemical
• Physical
Preventive Controls -Discussion
Questionsand
(Probably) Answers