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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Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 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

Chapter 1: The Food Safety Plan

Table of Contents

1.1 Purpose of this Chapter

1.2 What is a Food Safety Plan?

1.3 Who Develops the Food Safety Plan for a Facility?

1.4 What are the Differences Between a HACCP Plan and a Food Safety 

Plan?

1.4.1 Hazard Analysis and Controls to Address the Hazards

1.4.2 Monitoring

1.4.3 Corrective Actions and Corrections

1.4.4 Verification

1.4.5 Validation

1.4.6 Recall plan

1.5 What if a Facility Already Has a HACCP Plan?

1.6 What Format Is Required for a Food Safety Plan?

 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 Chapter 1 that we issued for public comment in August 2016.
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1.7 When Are Changes Needed for a Food Safety Plan?

1.8 References

1.1 Purpose of this Chapter

The guidance provided in this chapter is intended to help you understand what a food safety 

plan is and how it differs from a HACCP plan. The PCHF requirements specify that a facility 

must prepare, or have prepared, and implement a written food safety plan. See 21 CFR 

117.126.

1.2 What is a Food Safety Plan?

A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food 

safety system that provides a systematic approach to the identification of food safety hazards 

that must be controlled to prevent or minimize the likelihood of foodborne illness or injury. It 

contains a collection of written documents that describes activities that ensure the safety of food 

during manufacturing, processing, packing, and holding. See 21 CFR 117.126.

Below, we describe the written documents that make up the FSP (see 21 CFR 117.126(b)). 

• Hazard analysis to identify whether there are hazards requiring a preventive control. This hazard 

analysis must be written, regardless of whether any hazards requiring a preventive control are 

identified. (Some facilities may not identify any hazards requiring a preventive control.) 

• When the hazard analysis identifies hazards requiring a preventive control, the FSP also includes the 

following written documents:

o Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food,

to ensure safe food is produced, including:

 Process controls

 Food allergen controls

 Sanitation controls

 Supply-chain controls

 Recall plan

 Other controls

o Procedures for monitoring the implementation of the preventive controls, as 

appropriate to the nature of the preventive control and its role in the facility’s food 

safety system

o Corrective action procedures, as appropriate to the nature of the hazard and the 

nature of the preventive control

o Verification procedures, as appropriate to the nature of the preventive control and its 

role in the facility’s food safety system 

This written FSP is a record that you must maintain. See 21 CFR 117.126(c) and 21 CFR part 

117, subpart F, particularly 21 CFR 117.310. In addition, you must maintain records to 

document that you are implementing the FSP. (See 21 CFR 117.190.) 
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The FSP starts with a hazard analysis of all ingredients and process or manufacturing steps 

(see Chapter 2 of this guidance). A “hazard” is any biological, chemical (including radiological), 

or physical agent that has the potential to cause illness or injury. It is important to understand 

that for the purposes of food safety, the term “hazard” refers only to the conditions or 

contaminants in food that are capable of causing illness or injury to people. These include 

hazards that occur naturally, that are unintentionally added or that may be intentionally added to 

a food for purposes of economic gain (i.e., economic adulteration). Many conditions are highly 

undesirable in food, such as the presence of insects, hair, filth or spoilage, and violations of 

regulatory food standards. All of these defects should be controlled in food processing; often, 

however, these defects do not directly affect the safety of the product. Unless these conditions 

directly affect food safety, documents addressing these issues are not included in an FSP. If 

the hazard analysis does not identify any hazards requiring a preventive control, the only 

document in the FSP would be the hazard analysis. 

1.3 Who Develops the Food Safety Plan for a Facility?

A “preventive controls qualified individual” (PCQI) must develop (or oversee the development of) 

the FSP. A PCQI is a person with the education, training, or experience (or a combination of 

these) to develop and apply a food safety system. A PCQI can be qualified through job 

experience or by completing training equivalent to the standardized curriculum recognized as 

adequate by FDA (e.g., the Food Safety Preventive Controls Alliance (FSPCA) training). The 

PCQI does not need to be an employee of the facility. See 21 CFR 117.126(a) and the 

definition of PCQI in 21 CFR 117.3.

The FSP must be signed and dated by the owner, operator or agent in charge of the facility 

when it is first completed and whenever the plan is modified (See 21 CFR 117.310.). See 

section 1.6 of this document for information on signing an FSP that consists of multiple 

components such as HACCP plans, prerequisite programs, a recall plan and a variety of 

procedures. 

1.4 What are the Differences Between a HACCP Plan and a Food 

Safety Plan?

Hazard Analysis and Critical Control Points (HACCP) is a preventive food safety strategy that is 

a systematic approach to the identification and assessment of the risk of hazards from a 

particular food or food production process or practice and the control of those hazards that are 

reasonably likely to occur. HACCP systems have been mandated by U.S. Federal regulations 

issued by the Food and Drug Administration (FDA) for seafood and juice and by the Food 

Safety and Inspection Service (FSIS) for meat and poultry. 

The preventive controls approach to controlling hazards used in an FSP incorporates the use of 

risk-based HACCP principles in its development. (See the HACCP principles and their 

application as described by the National Advisory Committee on Microbiological Criteria for 

Foods.) Although an FSP and a HACCP plan are similar, they are not identical. Table 1-1

compares what is required for the elements of each type of plan. In the following paragraphs, 

we briefly discuss each of these elements. 
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Table 1-1 Comparison of Elements of a HACCP Plan and a Food Safety Plan 

Element HACCP Plan Different in Food Safety Plan

Hazard Analysis Biological, chemical, 

physical hazards

Chemical hazards include radiological

hazards, consideration of economically 

motivated adulteration (21 CFR 

117.130(b)(1)(ii))

Preventive Controls CCPs for processes Process CCPs + controls at other 

points that are not CCPs (21 CFR 

117.135(a)(2))

Parameters and values Critical limits at CCPs Parameters and minimum/maximum 

values (equivalent to critical limits for 

process controls) (21 CFR 

117.135(c)(1))

Monitoring Required for CCPs Required as appropriate for preventive 

controls (21 CFR 117.145)

Corrective actions and 

Corrections

Corrective actions Corrective actions or corrections as 

appropriate (21 CFR 117.150(a))

Verification (including 

validation)

For process controls Verification as appropriate for all 

preventive controls; validation for 

process controls; supplier verification 

required when supplier controls a 

hazard (21 CFR 117.155, 117.160)

Records For process controls As appropriate for all preventive 

controls (21 CFR 117.190)

Recall plan Not required in the plan Required when a hazard requiring a 

preventive control is identified (21 CFR 

117.139)

1.4.1 Hazard Analysis and Controls to Address the Hazards 

In developing a HACCP plan, the hazard analysis leads to the identification of critical control 

points (CCPs) where essential process controls are needed to prevent a foodborne hazard from 

causing illness or injury. Once CCPs are identified, critical limits are established that define the 

operating conditions in the process that must be effectively managed and monitored to control 

the hazard. When critical limits are not met, predefined corrective actions are taken. All of the 

steps in a HACCP plan are recorded and verified to ensure the system is operating as intended. 

The FSP also begins with a hazard analysis, which includes consideration of radiological 

hazards as chemical hazards, as well as hazards due to economically motivated adulteration, 

such as addition of dyes containing lead to spices to enhance color. The outcome of the hazard 
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analysis is the facility’s determination of whether there are any known or reasonably foreseeable 

hazards that require a preventive control. In an FSP, preventive controls may be applied at 

CCPs, but also at points other than at CCPs. The FSP includes control measures that, under 

the HACCP approach, may have been included in prerequisite programs or CGMPs. For 

example, supplier controls and food allergen controls have often been addressed through 

prerequisite programs, and sanitation controls have often been addressed through CGMPs. 

Process controls in an FSP will have parameters with minimum or maximum values, which are 

equivalent to the critical limits for HACCP CCPs. The use of preventive controls in an FSP may 

expand beyond CCPs by identifying and providing controls that may not be process-related, but

are still important in the control of a hazard. Critical limits (minimum or maximum values) may

not be practical or needed for non-process-related preventive controls, such as using hygienic 

zoning controls to prevent cross-contact and cross-contamination or ensuring that suppliers 

have adequately controlled hazards in the foods they are providing a manufacturer/processor. 

1.4.2 Monitoring 

In a HACCP plan, the CCPs are always monitored. In an FSP, preventive controls are only 

monitored as appropriate to the nature of the preventive control and its role in the facility’s food 

safety system, and some preventive controls that are not applied at CCPs may not be 

monitored. 

1.4.3 Corrective Actions and Corrections 

In a HACCP plan, corrective actions are taken for deviations from a critical limit at a CCP. An 

FSP also provides for facilities to take corrective actions. However, immediate corrections (e.g., 

re-cleaning and sanitizing a line before start-up of production when food residue remains after 

cleaning) may be more appropriate for some preventive controls than a specific corrective 

action involving product risk evaluations of product safety for some preventive controls. The 

requirements for an FSP provide this flexibility. 

1.4.4 Verification 

In a HACCP plan, verification activities take place for process controls to ensure the process 

can control the hazards and the HACCP plan is being followed. In an FSP, verification activities 

will also be applied to preventive controls, but because preventive controls are not just process 

controls, there is flexibility to conduct verification activities as appropriate to the food, the facility 

and the nature of the preventive control and its role in the food safety system. 

1.4.5 Validation 

Some HACCP systems (e.g., for juice, and for meat and poultry products) require validation of 

the HACCP plan as a whole. In an FSP, validation means obtaining and evaluating scientific 

and technical evidence that a control measure, combination of control measures, or the food 

safety plan as a whole, when properly implemented, is capable of effectively controlling the 

identified hazards. The extent of validation activities may be less rigorous for some preventive 

controls than others, or may not be required (e.g., sanitation controls). 

1.4.6 Recall plan 

In a HACCP plan, recall plans have not been included. In an FSP, a Recall Plan must be 

prepared for each product for which a hazard requiring a preventive control has been identified. 
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1.5 What if a Facility Already Has a HACCP Plan?

If you have an existing HACCP plan, you should determine if it satisfies all the PCHF 

requirements in part 117. You can use existing programs, procedures, and records and 

supplement these with any additional information required, such as a supply-chain program. 

1.6 What Format Is Required for a Food Safety Plan?

There is no standardized or required format for an FSP. This guidance provides flexibility in its 

approach to guide you in identifying and establishing preventive controls for different types of 

hazards identified in your hazard analysis. You can use whatever format works best for your 

facility, provided that the FSP includes all the required information. The formats shown in this 

guidance are for illustrative purposes only and may not be complete. The FSPCA training 

materials have FSP worksheets and teaching example model FSPs that may be helpful. 

The FSP may consist of one or more existing HACCP plans, one or more prerequisite programs 

that include food safety controls, a recall plan, a written supply-chain program, written 

verification procedures such as environmental monitoring, and any other components specified 

in the PCHF requirements. You have flexibility in how to organize these documents within your 

FSP. One approach for organizing the FSP to allow for signing and dating it is to collect all 

these documents in a single location (e.g., a binder or folder) with a cover page containing the 

signature of the owner, operator, or agent in charge of the facility and the date on which the

cover page was signed. However, because the FSP also could be a set of documents kept in 

different locations within the facility, another approach is for the owner, operator, or agent in 

charge of the facility to sign and date a list of the relevant documents (e.g., as in a Table of

Contents).

1.7 When Are Changes Needed for a Food Safety Plan?

The FSP is a dynamic document that reflects your current hazard analysis, preventive controls, 

and applicable procedures. The FSP as a whole must be reanalyzed at least every 3 years. The 

reanalysis may be limited to the applicable portion of the FSP when you make changes to your 

system or equipment, when you become aware of new information about potential hazards 

associated with the food or your facility, when there is an unanticipated food safety problem, or 

when you find that a preventive control, combination of preventive controls, or the FSP itself is 

ineffective. See 21 CFR 117.170. 

1.8 References

National Advisory Committee on Microbiological Criteria for Foods (NACMCF). 1998. “Hazard 

Analysis and Critical Control Point Principles and Application Guidelines.” J Food Protect 61: 

1246-1259.