OVERVIEW

Food Safety Modernization Act (FSMA)

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year
from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention.
This is a significant public health burden that is largely preventable. FSMA aims to ensure the U.S. food
supply is safe by shifting the focus from responding to contamination to preventing it.

If you manufacture your products you are required to file for a State Manufacturers License, register with
the Food and Drug Administration (FDA) and be FSMA compliant, (see exemptions below). If you get
any ingredients from outside your state and/or your products sell/ship across state lines you are required
to be FSMA compliant; expect an FDA inspection.

Compliance clarification:
 Retail store that sell ONLY direct to consumers are exempt.
 However, if a Retail Store manufactures their products at a separate location/facility
from the store, the exception does not apply and they are required to be FSMA
compliant.
 “Farm-Operated Business” may sell direct to consumers via roadside stands, farmers
markets, etc. are exempt. (By “farm-operated business,” FDA means a business that is
managed by one or more farms and that conducts manufacturing/processing not on the
farm(s).
 In general, domestic and foreign food facilities (facilities that manufacture, process,
pack, or hold food, as defined 21 CFR 1.227, for human or animal consumption in the
U.S.) that are required to register with section 415 of the Food, Drug, & Cosmetic Act
must comply with the requirements for risk-based preventive controls mandated by the
FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good
Manufacturing Practices (cGMPs) of this rule (unless an exemption applies).

Small Business defined as less than 500 full time employees:

 Compliance required by September 18, 2017

Very Small Business defined as less than $1 million sales/year:

 Maintain records supporting Qualified Facility Status* by 1/1/16
 Compliance required by September 17, 2018
* A Qualified Facility MUST submit qualifying notifications to FDA during the same two year
timeframe that the facility is required to update its Facility Registration.

To simplify, the overall FSMA distinction is if you are a Manufacturer that Wholesales your product, you
are required to be FSMA compliant. (Think a little bit pregnant.) The Rationale behind FSMA Retail vs.
Wholesale:

Example: Fresh Banana

 Retail: Eat a fresh banana immediately. No time delay, which doesn’t allow for growth
of pathogen.
 Wholesale: Fresh Banana is an ingredient in finished product. However, the finished
product doesn’t freeze immediately, it takes time ….. temperature and time allow for
pathogen growth and risk.
However, regardless of the Size and Scope of your Operation and whether or not you are technically
required under FSMA, it is incumbent on you, the Business Owner, to take proper steps to insure your
product is safe!

Steps to Developing a Food Safety Plan

Specific for your Company

A) Food Safety Plan Manual:

Table of Contents

Chapter 1: Introduction

Begin with a Welcome letter to provide information on the scope of operations of your
Company, your Quality Control Programs, and your compliance with FDA Food Safety
Modernization Act (FSMA). We recommend your Welcome Letter describes your business, who
you are, what you do, your team, key players, customer base, products and overall scope of
your operation, a floor plan, and if you have received any special certifications, training, or third
party audits. See sample Welcome Letter Template.

Chapter 2: Core Programs – Core programs are steps or procedures, including Good Manufacturing
Practices (GMPs) and Sanitation Standard Operating Procedures (SSOPs), which control the operational
conditions within your Company and promote environmental conditions that are favorable for the
production of safe food.

 Pre-Requisite Program, which includes:

 Premises:
 Outside Property – Describe desired condition of exterior of building, example
free of debris and refuse to prevent harborage of pests, no roof leaks, etc.
 Building – describe desired condition of and features in place to promote Food
Safety, such as maintained in good repair to prevent access by pests, prevent
contamination and adequate space for all operations, production areas
separated from other operations to prevent contamination, positive pressure
maintained in production areas, restrooms self-closing doors, hand washing
stations available in production areas and wash hand signs are posted in
restrooms and break areas, etc.
 Water Supply – detail type of water and biological testing utilized, frequency,
records retention, example: are hose equipped with anti-backflow devices
 Ice Supply – detail bacteriological testing frequency, record retention and how
water treated.
 Receiving and Storage – Detail key ingredients receiving protocols, such as letter of
guarantee, certificates of analysis, record retention, all ingredients and packaging meet
the requirements and regulations promulgated by the FDA, as well as local and State
law. Detail receiving and storage procedures and how ongoing compliance monitored.
 Equipment Maintenance Program
 Equipment Calibrations
 Preventative Maintenance
 Personnel Training – new hire, ongoing training sessions, topics and frequency
 Sanitation – detail for cleaning of all equipment, utensils, overhead structures, floors,
shoes, walls, drains, pallets, door knobs, production keyboards, key pads, sinks, water
 fountains, A/C filters, pipes and lines, drip gutters, uniforms, dolleys, hand trucks, jacks,
grease traps, dumpster slab, phones, refrigerators, conveyors, air curtains, fans, crates,
etc.
 Recall Program – detail that a recall program is in place outlining the procedure to
ensure that any food can be removed from the market efficiently and completely.
 Allergen Control Program – ensure there is an Allergen Control Program in place to
make sure allergenic ingredients do NOT find their way into products for which they are
not intended. Refer them to applicable Chapter/Section of Food Safety Plan Manual for
complete Allergen Control Program.

 Good Manufacturing Practices (GMPs): (helpful to prepare in both English and Spanish) – see
sample templates

 Apply to your company the following policies:

 Proper Hand Washing Procedures
 Pallet Cleaning Policy
 Plastic Crate Cleaning Policy
 Shoe Policy
 Uniform Policy
 Visiting Contractor Policy
 Tote Cleaning Policy
 Confined Space
 Lot Code / Traceability Policy /Product Labeling

 Sanitation Standard Operating Procedures (SSOP), which should include procedures for:
 Preparation of cleaners and sanitizers
 Clean in Place (CIP) or Clean Out of Place (COP) cleaning procedure for applicable
equipment

 Allergen Control Program – see sample template

 Supplier Verification Program – see sample templates

Note: If you are regularly getting a specific ingredient from a Grocery Store, Bulk
Warehouse, etc. make sure you Register with that Company for the specific ingredient
so they will timely notified in the event of a recall.

 Transporting / Delivering Standard Operating Procedures – see sample template

 Hold and Release Policy – detail Company policy and procedure

 Recall Program – see Sample template

Note: Mock Recall to be covered in Separate Manual for Foods Safety Plan Supporting
Documents – see Sample Templates

Chapter 3: Flow Chart

 Flow Chart – this will need to be developed specific to your Company to document the flow of
each type of ingredient received (i.e., refrigerated ingredients, frozen ingredients, pasteurized
frozen ingredients, bulk liquid sugar {applicable for Mix Manufacturing only}, Dry non-dairy
 ingredient, dry ingredient, pasteurized liquid ice cream mix, frozen cultures, spray dried
cultures, packaging, etc.) all the way through your process (i.e, specific storage handling,
blending, holding tanks, compressed air, flavor vats, ice cream freezing, fruit feeder, ripple
pump, inclusion staging, artisan ladling, package filling, package labeling, metal detector,
hardening, freezer storage, etc.) to finished product and distribution.

Chapter 4: Hazard Analysis

 Hazard Analysis – this will document each step in the Flow Chart, identify what potential
Hazards exist and what Preventative Controls you will apply to minimize the Hazard. - see
sample Hazard Analysis Worksheet

Chapter 5: Hazard Analysis Summary of Critical Control Points – this is only applicable if you are
making Mix. If you are receiving Ice Cream Mix this chapter is not applicable.

 Hazard Analysis Summary – this details any Critical Control Points (CCP) - see attached Hazard
Analysis Summary Template

Chapter 6: Record Keeping

 Record Keeping – detail your record keeping, list forms, timeframe, location of each applicable
record. In addition, create a Hazard Analysis – Specific Control Measure Record Keeping Log –
see attached sample template.

Chapter 7: Corrective Action

 Corrective Action –

 Hazard Analysis Critical Control Point (HACCP) / Food Safety Plan Review Schedule –
see sample template

 Critical Control Point (CCP) Deviation Records – in the event there is a CCP Deviation, it
is recommended you have a pre-made form to consistently address and document
corrective action. See attached sample template. (This is not applicable if you are not
making Mix).

 Policy Deviation Records - in the event there is a Policy Deviation, it is recommended

you have a pre-made form to consistently address and document corrective action. See
attached sample template.

Chapter 8: Third Party Certification

 Third Party Certification

Chapter 9: Environmental Monitoring Program – to be reviewed and implemented AFTER you have
developed a culture in your Company that prioritizes Food Safety and your Food Safety Plan Manual is
complete and actively in place. An environmental Monitoring Program is the validation step to confirm
the effectiveness of your Company’s Sanitation Program and further validate that the policies and
procedures in your Food Safety Plan are successful in eradicating conditions conducive to the growth of
pathogens. It is recommended that prior to implementing an Environmental Monitoring Program your
Company should already be conducting and obtaining good results from the following Microbiological
methods:
  Standard Plate Count
 Coliform Count
 Yeast and Mold Count
 Sampling Procedures
 Microbiological Specifications
 Pre-Operational Swabs
 Refractometer - only applicable if you are receiving liquid sugar {applicable for Mix
Manufacturing only}

We will cover this section in greater detail at the end of this program.

 Environmental Monitoring Program

 Environmental Monitoring Program
 Listeria Corrective Action Form
 Listeria Environmental Monitoring Program (LEMP) Decision Tree
 Third Party Finished Product Testing
 Production Room(s) Zone Map(s)

Don’t let the task at hand feel daunting;

FOCUS ON CORE PRINCIPLES OF PATHOGEN CONTROL:
 Principle # 1: Separate Raw from Ready –to-Eat

 Principle # 2: Good Manufacturing Practices (GMP’s) and Controlled Conditions

 Principle # 3: Sanitary Facility and Equipment Design

 Principle # 4: Effective Cleaning and Sanitation Procedures and Controls

 Principle # 5: Environmental Pathogen Monitoring

 Develop a culture of Food Safety! Food Safety needs to be EVERY Employee’s PRIORITY, not just
the employees in the Production Area.
 B) Supplementary Food Safety Plan Supporting Documents:
The Food Safety Manual is your Company’s policies, procedures and protocols. Whereas the
Supporting Document Manual details by Department or Area the actual steps you take on a daily,
weekly, monthly, semi-monthly or annual basis to ensure that you are doing what your Food Safety
Manual states. It is comprised of the supporting documentation. Remember, “If you didn’t
document it, it didn’t happen. And if you did document it, that’s exactly the way it did happen.”
Joseph Levitt, Partner, Hogan Lovells US, LLP

Table of Contents

Chapter 1: Mix Room – If your Company produces Mix, the type of documentation in this area
consists of:

 Sanitation and Cleaning Logs

 Daily Operating Procedure Log
 Overhead Pipe Cleaning and Foam Walls Log
 Monthly Valve Cleaning and Inspection Log
 Tool Cleaning Policy
 Hose Cleaning and Sanitation Procedure Log
 Fan Cleaning Procedure Log
 Quaternary Ammonia Fogger Procedure and Log
 Sugar Pump Filter Cleaning Log
 Holding Tank Temperature Log
 Monthly Plug Valve Inspection Chart
 Bag Lot Number Log
 Etc.

Chapter 2: Ice Cream Production Room – this is the Production Room your Company makes the
finished product, and list below are some of the type of documentation needed to support your Food
Safety Plan:

 Clean Up Check Off List Log

 Daily Sanitation Log
 Bucket Machine Cleaning Policy Log
 Monthly Checklist
 Quarterly Checklist
 Quarternary Ammonia Fogger Procedure and Log
 Monthly Butterfly Valve Cleaning and Inspection Log
 Bucket Part Lot Numbers
 Ingredient Lot Log
 Vat Ingredient Log
 Metal Detector Check Log
 Soft Serve Lot Log

Chapter 3: Warehouse and Distribution – again below are the types of supporting documents for this
Department / area:

 Dock Receiving Form

 Warehouse / Sanitation Team Checklist
  Warehouse Weekly Plant Checklist
 Warehouse Monthly Checklist
 Warehouse Quarterly Checklist
 Color Identification Chart
 Weekend or After Hours Plant Checklist
 Truck Cleaning Log
 Returned Tote / Crate Cleaning Log
 Refrigerator Temperature Log
 Daily Trash Removal Log
 Daily Handle, Key Pad, Keyboard/Mouse clean and Sanitize Log
 Daily Drain and Refrigerator Door Clean
 Plant Inspection Map Sign off Log
 New of Used Equipment Cleaning Policy
 Pallet Jack Identification Numbers Cleaning Log
 Dolley Identification Numbers Cleaning Log
 Weekly Equipment Cleaning Log
 Grease Trap Cleaning Policy and Log
 Refrigerator / Freezer Temperature Log
 Etc.

Chapter 4: Freezer - again below are the types of supporting documents for this Department / area:

 Freezer Weekly Checklist

 Freezer and Warehouse Laundry Log
 Product Return Policy

Chapter 5: Quality Control - again below are the types of supporting documents for this Department /
area:

 Quality Assurance Start-Up Checklist

 Start of Day QC Spot Inspection Checklist
 Weekly Plant Checklist
 Monthly Checklist
 Quarterly Check List
 Semi-Annual Plant Checklist
 Observations – AM and PM
 Annual Checklist

Chapter 6: Customer Complaint Form

Chapter 7: Mock Recall – see attached Sample Templates

Chapter 8: Security

 Plant and Personnel Security

Chapter 9: Chemicals –

 Chemical Handling Procedures

 Material Safety Data Sheets

Chapter 10: Maintenance - again below are the types of supporting documents for this Department /
area:
  Maintenance Precaution Policy
 Emergency Maintenance Policy
 Periodic Daily Checklist – Maintenance
 Monthly Maintenance Checklist
 Monthly Bleach Condensate on Pumps and Lines
 Quarterly Checklist – Maintenance
 Semi-Annual Maintenance Checklist
 Annual Checklist – Maintenance
 Dehumidifier Filter Changing Procedure Form
 Compressed Air Policy
 Preventative Maintenance Equipment

Chapter 11: Lab

 Laboratory Testing Procedures

 Dilution Procedure Using 3M Plates
 Sterility Controls Using 3M
 Lab- Mix Room Sanitizer Cleaning Solution Concentration
 Lab- Ice Cream Production Room Cleaning Solution Concentration
 Sanitizer Concentration at Start-Up Mix
 Sanitizer Concentration at Start-Up Ice Cream Production Room
 Standard Plate Count and Coliform Check Log
 Environmental Swabs

Chapter 12: Helpful Tools, Log Checklists, Misc. Signs

 QC During Operation Spot Inspection Checklist

 Master Log Checklist by Frequency
 Master Log Checklist by Department
 QC Close of Day Spot Inspection Checklist
 Miscellaneous Signage / Notices for Plant