Meets Regulation Assembling A Food Safety Plan For Your Brewery - - PowerPoint PPT Presentation

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,
• r 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
• thers 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 #1

Working 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 #2

Working 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-
• r 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 #3

Non-alcoholic Flavored Sparkling Water

Tamarind- Ginger Non- Alcoholic Soda

• Base
• Water
• CO2
• Flavor addition
• Tamarind extract
• Ginger extract

Ingredients

Tamarind- Ginger Non- Alcoholic Soda

• Microbiological
• Chemical
• Physical

Hazard Analysis - Discussion

Tamarind- Ginger Non- Alcoholic Sparkling Water

• Microbiological
• Chemical
• Physical

Preventive Controls - Discussion

Questions and (Probably) Answers