Where Innovation Meets Regulation...products • Introducing changes to existing brands •...

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