Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 1

Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 

Administration's (FDA or we) on this topic. It does not establish any rights for any person and is 

not binding on FDA or the public. You can use an alternative approach if it satisfies the 

requirements of the applicable statutes and regulations. To discuss an alternative approach, 

contact FDA’s Technical Assistance Network by submitting your question

at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.

Appendix 2: Food Safety Plan Forms

Table of Contents

Introduction

Form 2-A: FSPCA Form for Product Description

Form 2-B: FSPCA Form for Hazard Analysis

Form 2-C: FSPCA Form for Process Controls

Form 2-D: FSPCA Form for Sanitation Controls

FSPCA Food Allergen Control Forms

Form 2-E: FSPCA Form for Food Allergen Ingredient Analysis

Form 2-F: FSPCA Form for Food Allergen Label Verification List

Form 2-G: FSPCA Form for Production Line Food Allergen Assessment

Form 2-H: FSPCA Form for Food Allergen Controls

Form 2-I: FSPCA Form for Supply-chain-applied Preventive Controls 

Program

 1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and 

Applied Nutrition at the U.S. Food and Drug Administration. Underlined text in yellow highlights 

represents a correction from the draft Appendix 2 that we issued for public comment in August 2016.
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 2

Introduction

We recommend that you use worksheets to document the: 

• Product description; 

• Hazard analysis; 

• Process controls; 

• Sanitation controls; and

• Food allergen controls.

There is no standardized or mandated format for documenting the food safety plan. However, 

in this appendix we refer you to worksheets that were developed by Food Safety Preventive 

Controls Alliance (FSPCA). We recommend that you use forms such as these for documenting 

your food safety plan for two reasons: (1) These worksheets are used in training by the FSPCA

and, thus, you will be familiar with these forms if you take this training; and (2) these worksheets 

are similar to forms used in documenting Hazard Analysis and Critical Control Point (HACCP) 

plans and prerequisite programs and, thus, these worksheets may be similar to forms you are 

already using. 

The FSPCA makes these forms available on its website 

at https://www.ifsh.iit.edu/sites/ifsh/files/departments/fspca/pdfs/FSPCA_Ap2_Worksheets__V1.

1_Fillable.pdf. In this Appendix, we have modified the format of FSPCA’s forms for consistency 

with the formats we use for making documents accessible for persons using assistive 

technology such as a screen reader. You may obtain the current copy of FSPCA’s forms from 

its website.

In general, regardless of whether you use these worksheets, we recommend that you arrange 

the information in your food safety plan in a progressive manner that clearly explains the 

thought process for the hazard analysis and the individual steps in the Food Safety Plan. For 

example:

• Your hazard analysis should contain information to justify:

o Your identification of each hazard requiring a preventive control; and 

o The types of preventive controls applied;

• You should explain the details for each preventive control.

Other formats are entirely acceptable if they work for your organization. If you use another 

format, you should ensure that your format provides all of the information that the preventive 

controls rule requires for each required component of the food safety plan. See 21 CFR 

117.126, 117.305, and 117.310. 

Each FSPCA form has a form name, but does not have an identifying number. In this Appendix, 

we number each FSPCA form (Form 2-A, Form 2-B, etc.) to have a concise identifier for each 

form. 
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 3

Form 2-A: FSPCA Form for Product Description 

In Chapter 2 of this guidance, we recommend that you conduct certain preliminary steps before 

conducting your hazard analysis. One of these preliminary steps is to describe the product, its 

distribution, intended use, and consumer or end user of the product. The product description 

form that is commonly used in the development of HACCP plans can be used to do so. See 

Form 2-A. 

Below, we list the information that you will see on Form 2-A. When appropriate for clarity, we 

explain what type of information you would include for the listed information. Regardless of 

whether you use Form 2-A, we recommend that you include such information in any product 

description that you develop. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Product Name: i.e., the full name of the finished product. 

• Product Description, including Important food safety characteristics – i.e., descriptors such as readyto-eat (RTE), frozen; factors that can influence growth of pathogens, such as whether the food has a 

low pH or aw or contains preservatives. 

• Ingredients. 

• Packaging Used: e.g., type (bottle, box, can); material (plastic, glass, cardboard with liner); reduced 

oxygen packaging.

• Intended Use: e.g., intended for retail, foodservice, or further processing; whether the food is readyto-eat or ready-to-cook by the consumers; and what the potential is for mishandling or unintended 

use. 

• Intended Consumers: usually the general public; however, if a food product is intended specifically for 

susceptible populations such as hospitals, you should say so.

• Shelf Life. 

• Labeling Instructions Related to Safety: e.g., “keep refrigerated” or cooking instructions.

• Storage and Distribution: e.g., whether the food is stored and/or distributed refrigerated, frozen or at 

ambient temperatures. 
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 4

FORM 2-A PRODUCT DESCRIPTION

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Product Name(s)

Product Description, 

including Important Food 

Safety Characteristics

Ingredients

Packaging Used

Intended Use

Intended Consumers

Shelf Life

Labeling Instructions 

related to Safety

Storage and Distribution

Approved: (signature or initials)____________________________________________

Date: ___________________________________________________________________
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 5

Form 2-B: FSPCA Form for Hazard Analysis

In Chapter 2 of this guidance, we explain how to set up an adaptation of the “Hazard Analysis 

Worksheet” used in HACCP systems to organize your hazard analysis. See Form 2-B. Note that 

for brevity Form 2-B uses the term “potential hazard” rather than “known or reasonably 

foreseeable hazard.” 

See section 2.2.2 in Chapter 2 for an overview of how to set up columns 1-6 of Form 2-B. See 

the remainder of Chapter 2 for more detail about how to provide information on Form 2-B. 

Regardless of whether you use Form 2-B, we recommend that you include such information in 

your hazard analysis.
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 6

FORM 2-B HAZARD ANALYSIS*

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

(1)

Ingredient / 

Processing 

Step

(2)

Identify potential

food safety 

hazards 

introduced, 

controlled or 

enhanced at this 

step

B = biological 

C = chemical, 

including 

radiological 

P = physical

(3)

Are 

any potent

ial

food 

safety

hazards 

requiring 

preventive 

control?

(Yes/No)

(4)

Justify your 

decision for 

column 3

(5) 

What preventive 

control measure(s) 

can be applied to 

significantly minimize 

or prevent the food 

safety hazard?

Process including CCPs, 

Allergen, Sanitation, 

Supplier, other preventive 

control

(6)

Is the 

preventive 

control applied 

at this step?

(Yes/No)

* The current FSPCA form includes some additional features, such as a separate column for “Yes” and 

“No” responses and a separate row at each step for biological, chemical, and physical hazards (labeled 

B, C, and P, respectively).
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 7

Form 2-C: FSPCA Form for Process Controls

Chapter 5 of this guidance provides an overview of the application of preventive controls to 

significantly minimize or prevent the occurrence of biological, chemical, and physical hazards in 

finished foods and the food production environment. Chapter 5 also provides an overview of 

preventive control management components (i.e., monitoring, corrective actions and 

corrections, and verification activities (and their associated records)). When the preventive 

control that you identify is a process control, Form 2-C provides a format for you to specify the 

process control and the associated preventive control management components. 

Below, we list the information that you will see on Form 2-C. When appropriate for clarity, we 

explain what type of information you would include for the listed information. Regardless of 

whether you use Form 2-C, we recommend that you include such information in your food 

safety plan when you will implement a process control.

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Process Control: From the Hazard Analysis form, enter the steps identified as requiring a process 

control 

• Hazard(s): From the Hazard Analysis form, enter the hazard requiring a preventive control at each 

step listed in the “Process Control” column. 

• Parameters, values, or critical limits: Enter the parameters, and the associated minimum or 

maximum value (or critical limits) associated with the parameters. 

• Monitoring: In the columns provided, enter what will be monitored, how it will be monitored, the 

frequency that the monitoring will be done and who will do the monitoring (e.g., the position, such as 

“operator” or “QA technician”). 

• Corrective Actions: Describe the corrective actions that will be taken when deviations from the 

minimum/maximum values (or critical limits) for a parameter occur. 

• Verification: List the ongoing verification activities, including calibration (where appropriate) and 

records review. Although the form was designed to focus on ongoing verification activities, rather 

than data and information addressing validation, you also can list information such as a validation 

study on FSPCA Form 2-C if you find it useful to do so. 

• Records: List the names of the records that result from implementation of the process controls (e.g., 

cook log, cooling records, metal detector check log). 
8

FORM 2-C PROCESS CONTROLS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Process 

Control 

Step

Hazard(s) Critical Limits What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
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Appendix 2 (Food Safety Plan Forms) - Page 9

Process 

Control 

Step

Hazard(s) Critical Limits What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
10

Form 2-D: FSPCA Form for Sanitation Controls

The forthcoming Chapter 10 of this guidance will address sanitation controls, which can vary 

substantially from facility to facility. When the preventive control that you identify is a sanitation 

control, Form 2-D provides a format for you to specify the sanitation control and the associated 

preventive control management components. Although Form 2-D may not always be the most 

effective way to describe the many sanitation controls that may be employed, you may find 

Form 2-D helpful to summarize cleaning and sanitizing of a particular piece of equipment or 

particular locations in your plant where product is exposed to the environment. 

Below, we list the information that you will see on Form 2-D. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Location: Enter the location(s) in the plant where the sanitation control described on Form 2-D will be 

used. 

• Purpose: e.g., to remove food allergens, to reduce contamination with environmental pathogens 

• Frequency: How often the procedure is used (e.g., daily; after each production run; weekly;)

• Who: i.e., the position, such as “sanitation technician” or “sanitation supervisor”

• Procedure: You can write the procedure on the form or refer to a specific Standard Operating 

Procedure (SOP). Procedures can include cleaning procedures and monitoring procedures, such as 

measuring sanitizer concentration. 

• Corrections (Corrective Actions Where Appropriate) - e.g., recleaning equipment that is not visibly 

clean prior to production. In most cases, corrections are appropriate. However, you may want to 

include circumstances that would trigger corrective actions. 

• Records: the type of records you will maintain.

• Verification activities (such as records review) and the type of records maintained are listed. 
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 11

FORM 2-D SANITATION CONTROLS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Location

Purpose

Frequency

Who

Procedure

Monitoring

Corrections

(Corrective 

actions where 

necessary)

Records

Verification: (signature or initials)____________________________________________

Date: ____________________________________________________________________
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 12

FSPCA Food Allergen Control Forms

Chapter 5 of this guidance provides an overview of the application of preventive controls to 

significantly minimize or prevent the occurrence of biological, chemical, and physical hazards in 

finished foods and the food production environment. Chapter 5 also provides an overview of 

preventive control management components (i.e., monitoring, corrective actions and 

corrections, and verification activities (and their associated records)). Our forthcoming Chapter 

11 - Food Allergen Controls will provide a comprehensive guide to food allergen control.

When the preventive control that you identify is an allergen control, the FSPCA forms that we 

identify as Forms 2-E, 2-F, 2-G, and 2-H provide a format for you to specify the allergen control 

and the associated preventive control management components. 

• Form 2-E: FSPCA form for Food Allergen Ingredient Analysis. Use for conducting an allergen-specific 

hazard analysis of food ingredients.

• Form 2-F: FSPCA form for Food Allergen Label Verification List. Use to list the specific allergens to 

be listed in the “Contains” declaration on the product label.

• Form 2-G: FSPCA form for Production Line Food Allergen Assessment. Use to identify common and 

unique food allergens for products produced on a production line for the purpose of making decisions 

on scheduling (e.g., run unique allergens last) and allergen cleaning information (e.g., conduct a full 

allergen cleaning before running products without the allergen)

• Form 2-H: FSPCA form for Food Allergen Controls. Use to describe any food allergen controls and 

associated preventive control management components.

Regardless of whether you use these FSPCA Food Allergen forms, we recommend that you 

conduct a food allergen ingredient analysis and include information such as you see in Form 2-

E in your food safety plan. if your food allergen ingredient analysis identifies food allergens that 

will be (or may be) in your products, we recommend that you include information such as you 

see in the remaining FSPCA forms in your food safety plan.
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 13

Form 2-E: FSPCA Form for Food Allergen Ingredient Analysis

Below, we list the information that you will see on Form 2-E. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Raw Material Name: List all raw materials received in the facility

• Supplier: Identify the supplier for each raw material

• Food Allergens in Ingredient Formulation: Identify any food allergens in each listed raw material –

e.g., by reviewing ingredient labels or contacting the manufacturer

• Food Allergens in Precautionary Labeling: List any allergens listed in precautionary labeling (such as 

a “May Contain” statement) in raw materials that you receive 
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 14

FORM 2-E FOOD ALLERGEN INGREDIENT ANALYSIS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Food Allergens in Ingredient Formulation or in Precautionary Labeling

Raw Material Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut

(market name)

Peanut

Fish 

(market name)

Shellfish (market 

name)

Food Allergens 

in Precautionary 

Labeling
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 15

Form 2-F: FSPCA Form for Food Allergen Label Verification List 

Below, we list the information that you will see on Form 2-F. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Product: List each product that will contain (or may contain) a major food allergen

• Allergen Statement: Specify the “Contains” statement that you will include on the product label for that 

product.

FORM 2-F FOOD ALLERGEN LABEL VERIFICATION LIST

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Product Allergen Statement

Contains:

Contains:

Contains:

Contains:
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 16

Form 2-G: FSPCA Form for Production Line Food Allergen Assessment 

Below, we list the information that you will see on Form 2-G. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Product Name: List each product made in the plant

• Production Line: Identify the production line used for each listed product

• List the allergens that you will add to the listed product, including any allergens listed in precautionary 

labeling if you determine there is the potential for these to contaminate the line.

FORM 2-G PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Product Name Production Line 

Egg

Milk

Soy

Wheat

Tree Nut

(market name)

Peanut

Fish

(market name)

Shellfish

(market name)
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 17

Form 2-H: FSPCA Form for Food Allergen Controls

The FSPCA Food Allergen Control Form (Form 2-H) is modeled after the FSPCA Process 

Controls Form (Form 2-C). Below, we list the information that you will see on Form 2-H. When 

appropriate for clarity, we explain what type of information you would include for the listed 

information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Allergen Control Step: Describe the step at which the allergen control is being applied e.g., at label 

receipt or label application for label controls; at post-production sanitation for equipment cleaning. 

• Hazard: e.g., undeclared allergen due to incorrect label; undeclared allergen due to cross-contact. 

• Criterion: Specify the criterion you are trying to meet, e.g., all finished product labels declare the 

allergens in the product. 

• Monitoring; In the columns provided, enter what will be monitored (e.g., the label ingredient 

declaration), how it will be monitored (e.g., the label will be visually checked and compared to the 

product formulation), the frequency that the monitoring will be done (e.g., each new order of labels 

before they are released to production), and who will do the monitoring (e.g., label coordinator). 

• Corrective Actions: In some cases, corrections will be appropriate. However, you should include 

circumstances that would trigger corrective actions. 

• Verification: List the verification activities, such as records review. 

• Records: List the names of the records that result from implementation of the food allergen controls 

(e.g., label review log).
18

FORM 2-H FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Allergen

Control 

Step

Hazard(s) Criterion What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 19

Allergen

Control 

Step

Hazard(s) Criterion What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 20

Form 2-I: FSPCA Form for Supply-chain-applied Preventive Controls 

Program

Chapter 5 of this guidance provides an overview of the application of preventive controls to 

significantly minimize or prevent the occurrence of biological, chemical, and physical hazards in 

finished foods and the food production environment. Chapter 5 also provides an overview of 

preventive control management components (i.e., monitoring, corrective actions and 

corrections, and verification activities (and their associated records)). Our forthcoming 

Guidance for Industry, Supply-Chain Programs, Draft Guidance, will provide a comprehensive 

guide to supply-chain controls.

When the preventive control that you identify is a supply-chain control, Form 2-I provides a 

format for you to specify the preventive control and the associated preventive control 

management components appropriate for a supply-chain program. You would use a separate 

form for each ingredient that would have a supply-chain program control. Below, we list the 

information that you will see on Form 2-I. When appropriate for clarity, we explain what type of 

information you would include for the listed information. Regardless of whether you use Form 2-

I, we recommend that you include such information in your food safety plan when you will 

implement a supplier control.

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Hazards requiring a supply-chain-applied control: List each hazard requiring a preventive control 

• Preventive controls applied by the supplier: When applicable, list any preventive controls applied by 

the supplier

• Verification activities: List the verification activities you will conduct – i.e., onsite audits; sampling and 

testing of the raw material or other ingredient; review of the supplier’s relevant food safety records; 

and other appropriate supplier verification activities based on supplier performance and the risk 

associated with the raw material or other ingredient.

• Verification procedures: e.g., procedures for receiving raw materials and other ingredients; audit 

procedures

• Records: e.g., records documenting receipt from an approved supplier, records documenting review 

of supplier verification activities
Contains Non-binding Recommendations

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Appendix 2 (Food Safety Plan Forms) - Page 21

Form 2-I: Supply-chain-applied Preventive Controls Program

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Determination of Verification Procedures

Ingredient:

Hazards requiring a 

supply-chain-applied 

control

Preventive controls applied 

by the supplier

Verification activities

Verification procedures

Records

Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control

Ingredient 

(requiring 

supply-chainapplied control)

Approved 

Supplier

Hazard(s) requiring 

supply-chainapplied control

Date of 

Approval

Verification 

method

Verification 

records

Receiving Procedure for Ingredients Requiring a Supply-chain-applied 

Control 

[Document procedures used for receiving ingredients requiring a supply-chain-applied control.]