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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Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 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

Chapter 5: Application of Preventive Controls and Preventive 

Control Management Components

Table of Contents

5.1 Purpose of this Chapter

5.2 Overview of the Application of Preventive Controls for Biological 

Hazards

5.3 Overview of the Application of Preventive Controls for Chemical 

Hazards

5.3.1 Examples of the Application of Preventive Controls for Chemical Hazards

5.3.2 Considerations Applicable to Radiological Hazards

5.3.3 Examples of the Control of Food Allergen Hazards

5.4 Overview of the Application of Preventive Controls for Physical 

Hazards

5.5 Preventive Control Management Components

5.5.1 Overview of Preventive Control Management Components

 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 5 that we issued for public comment in August 2016.
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5.5.2 Monitoring

5.5.3 Corrective Actions and Corrections

5.5.4 Verification

5.5.5 Records

5.6 References

5.1 Purpose of this Chapter

The guidance provided in this chapter is intended to help you identify and implement preventive 

controls, and associated preventive control management components, as a part of your food 

safety plan. See 21 CFR 117.135 and 117.140. Note that if you determine through your hazard 

analysis that there are no hazards requiring preventive controls, you must still document that 

determination in your written hazard analysis (see 21 CFR 117.130(a)(2)). However, you would 

not need to establish preventive controls and associated preventive control management 

components.

This chapter 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. This chapter also provides an overview of 

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

corrections, and verification activities (and their associated records)). Chapters 6 through 13 of 

this guidance provide more detailed examples of the application of preventive controls and

associated preventive control management components. 

This chapter does not provide all the details needed for complete programs. You have the 

flexibility to identify and implement preventive controls, and associated preventive control 

management components, from among all procedures, practices, and processes that are 

available to you and that would provide assurances that the hazard is controlled (i.e., 

significantly minimized or prevented).

5.2 Overview of the Application of Preventive Controls for Biological 

Hazards

Table 5-1 provides examples of the application of preventive controls to significantly minimize or 

prevent the occurrence of ingredient-related and process-related biological hazards.

Table 5-1 provides general information about the effects of the listed preventive controls but is 

not intended to imply that a particular preventive control has been validated for control of 

specific pathogens in specific foods. You are responsible for validating specific preventive 

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

safety system (see 21 CFR 117.160(a)). 

Table 5-1 does not address the application of preventive controls to facility-related hazards. 

See “Chapter 10 – Sanitation Controls” of this guidance for additional information on the 

application of sanitation controls to address facility-related hazards. 
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Table 5-1 Application of Common Preventive Controls to Ingredient-Related and ProcessRelated Biological Hazards 

Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Lethal 

Treatments

Heat (e.g., 

cooking, 

roasting, 

baking)

In general,

heat 

processes 

will not 

eliminate 

spores of 

bacterial 

pathogens 

Eliminates 

vegetative 

cells of 

pathogens

Will not eliminate 

preformed toxins 

of S. aureus and 

B. cereus emetic 

toxin

Heat processing 

will inactivate 

parasites found 

in foods; specific 

times and 

temperatures 

are dependent 

on the parasite, 

food matrix, and 

process used

Process

Control –

Lethal 

Treatments

Irradiation, 

ionizing

The doses 

approved in 

the U.S. will 

not eliminate 

spores of 

bacterial 

pathogens in 

most foods

Eliminates 

vegetative 

cells of 

pathogens

Will not eliminate 

preformed toxins 

of S. aureus and 

B. cereus emetic 

toxin

Limited uses for 

parasite control; 

depending on 

dose, approved 

uses for 

foodborne 

pathogens may 

inactivate 

parasites found 

in foods 

Process

Control –

Lethal 

Treatments

Antimicrobial 

Fumigation, 

e.g., 

Propylene 

Oxide (PPO) 

or Ethylene 

Oxide (ETO)

Will not 

eliminate 

spores of 

bacterial 

pathogens

Defined PPO 

processes 

have been 

shown to 

reduce 

Salmonella

by 5 logs in 

certain foods

Unknown, but 

unlikely to have 

an effect on 

preformed toxins 

of S. aureus and 

B. cereus emetic 

toxin

Ozone has been 

found to 

inactivate select 

parasites (e.g., 

C. parvum

oocysts) 
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Lethal 

Treatments

High Pressure 

Processing 

(HPP)

In general,

HPP will not 

eliminate 

spores of 

bacterial 

pathogens 

(FDA, 2000)

Eliminates 

vegetative 

cells of 

pathogens

(FDA, 2000)

Will not eliminate 

preformed toxins 

of S. aureus and 

B. cereus

• Will 

eliminate 

parasitic 

worms of 

Trichinella 

spiralis at >

200 MPa for 

10 min 

• No 

infectivity of 

Cryptospori

dium

oocysts 

when 

treated by 

HPP at 

5.5X108 Pa 

(80,000 psi) 

for 60 sec in 

apple and 

orange juice 

• Information 

is lacking on 

the pressure 

resistances 

of other 

parasites

Process

Control –

Time / 

Temperature 

of Holding

Refrigeration Used to 

control 

growth of 

sporeforming 

bacterial 

pathogens

Depending 

on the 

temperature, 

refrigeration 

will inhibit 

growth of 

many 

pathogens. 

However, 

pathogens 

such as L. 

monocytogen

es and some 

strains of B. 

cereus may 

grow at 

refrigeration 

temperatures

Will prevent the 

formation of

toxins of S. 

aureus.

Depending on 

the temperature, 

will prevent 

formation of B. 

cereus toxins. 

Will have no 

effect on 

preformed toxins

Limited 

information; 

generally not 

applicable to 

parasites 

because 

parasites do not 

grow in food
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Time / 

Temperature 

of Holding

Freezing Used to 

control 

growth of 

spore 

forming 

bacterial 

pathogens, 

but the 

spores will 

survive 

freezing well

Freezing 

prevents 

growth of 

vegetative 

cells of 

pathogens. 

Depending 

on the 

temperature, 

the numbers 

of some 

pathogens 

may be 

reduced over 

time;

however you 

cannot count 

on freezing 

to eliminate 

pathogens, 

and many 

can survive 

for an 

extended 

time 

Freezing that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxins 

There are 

specific 

schedules of 

time and 

temperature 

shown to 

inactivate 

parasites; 

Cyclospora is 

known to be at 

least somewhat 

resistant to 

freezing 

because an 

outbreak 

occurred 

attributed to 

raspberries in 

cake that was 

previously 

frozen at about 

26°F (–3.3° C) 

Process

Control –

Formulation

Water activity 

control

Reducing the 

water activity 

(e.g., by 

adding 

solutes such 

as sugar and 

salt) to 0.92 

or below will

inhibit 

outgrowth of 

spores

Reducing the 

water activity 

(e.g., by 

adding 

solutes such 

as sugar and 

salt) to 0.85 

or below will 

inhibit growth 

of vegetative 

cells of 

pathogens 

Water activity 

that prevents 

growth will 

prevent formation 

of toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxins

Limited 

information; 

generally not 

applicable to 

parasites 

because they do 

not grow in food
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Formulation

Acidification Lowering the 

pH by the 

addition of 

acid can 

inhibit spores 

from 

germinating, 

will not 

eliminate the 

spores

In, general, 

you can rely

on added 

acid to 

prevent 

growth of 

vegetative 

bacterial 

pathogens, 

but you 

cannot rely 

on added 

acid to 

eliminate 

vegetative

cells of 

bacterial 

pathogens

A pH that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxins

No information 

for use as 

control in foods

Process

Control –

Formulation

Adding 

preservatives

Will not 

eliminate 

spores of 

bacterial 

pathogens, 

but can 

prevent

germination 

of spores of 

certain 

species 

Various 

preservative 

chemicals 

have specific 

action 

against some 

vegetative 

cells of 

bacterial 

pathogens 

and/or fungi

that prevent 

growth

Formulations 

that prevent 

growth will 

prevent formation 

of toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

for use as 

control in foods

Process

Control –

Dehydration

Air drying Will not 

eliminate 

spores of 

bacterial 

pathogens, 

but limits or 

inhibits 

outgrowth

While drying 

may 

inactivate 

some 

pathogens, 

others (e.g.,

Salmonella) 

may survive 

drying for 

fairly long 

times 

Drying that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

on effect on 

parasites in 

foods
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Dehydration

Freeze drying In general, 

serves to 

preserve 

microorganis

ms, but 

inhibits 

outgrowth

In general, 

serves to 

preserve 

microorganis

ms, but 

inhibits 

growth

Drying that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

on effect on 

parasites in 

foods

Process

Control –

Dehydration

Spray drying In general,

spores of 

bacterial 

pathogens 

will not be 

eliminated, 

but inhibits 

outgrowth

Some 

pathogens 

may survive 

spray drying 

depending 

upon the 

product 

formulation. 

Growth will 

be inhibited

Drying that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

on effect on 

parasites in 

foods 

Chapters 6 through 9 of this guidance provide specific examples of the application of some of 

these preventive controls. Table 5-2 lists these chapters and the examples covered in these 

chapters. Table 5-2 also lists examples of sanitation controls, which are covered in Chapter 10.

Table 5-2 Chapters in this Guidance that Provide Examples of the Application of 

Common Preventive Controls for Ingredient-Related and Process-Related Biological 

Hazards

Hazard Preventive 

Control Examples of Preventive Controls Chapter

Bacterial 

pathogens that 

survive the lethal 

treatment

Process Control –

Lethal Treatments

• Cooking of RTE soups (frozen and 

refrigerated)

• Baking of RTE cookies 

6

Bacterial 

pathogens that

grow, including 

those that produce 

toxin, due to time/ 

temperature 

abuse

Process Control –

Time / 

Temperature of 

Holding

• Refrigeration of fresh fruit salads 

• Control of temperature during 

thawing to prevent microbial growth

7

Bacterial 

pathogens that

grow, including 

those that produce 

toxin, due to poor 

formulation control

Process Control -

Formulation

• Acidification of prepared vegetable 

salads 

• Water activity control in refrigerated 

cookie dough

8
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Hazard Preventive 

Control Examples of Preventive Controls Chapter

Bacterial 

pathogens that 

grow, including 

those that produce 

toxin, due to 

inadequate drying

Process Control –

Drying/dehydration

• Drying of milk to produce spraydried milk powder 9

Bacterial 

pathogens that 

contaminate 

product due to

poor sanitation

Sanitation Control 

– Cleaning / 

sanitizing food 

contact surfaces

• Controlling presence of bacterial 

pathogens in RTE prepared 

sandwiches by sanitation

10

Recontamination 

of an RTE product 

with an 

environmental 

pathogen 

Sanitation –

Prevention of 

recontamination 

from the 

environment

• Use of hygienic zoning as a 

component of a program for 

prevention of recontamination of ice 

cream with environmental 

pathogens 

10

5.3 Overview of the Application of Preventive Controls for Chemical 

Hazards

5.3.1 Examples of the Application of Preventive Controls for Chemical 

Hazards

Table 5-3 provides examples of the application of preventive controls to significantly minimize or 

prevent the occurrence of ingredient-related chemical hazards in finished foods. See “Chapter 

12 – Preventive Controls for Chemical Hazards” of this guidance for further examples of the 

implementation of preventive controls for chemical hazards. 
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Table 5-3 Examples of the Control of Ingredient-Related Chemical Hazards

Preventive 

Control

Common Procedures, 

Practices, and Processes

Examples of Applicability to Chemical Hazards

Supply-Chain 

Program

Establish and implement a riskbased supply-chain program 

with supplier approval and 

verification activities (as a 

means of ensuring that raw 

materials and other ingredients 

are procured from those 

suppliers that can meet 

company specifications and 

have appropriate programs in 

place)

• Applicability to heavy metals: approved 

suppliers control arsenic and lead in raw 

agricultural commodities such as rice and 

carrots 

• Applicability to naturally occurring toxins: 

approved suppliers control growth of 

mycotoxin-forming fungi in stored raw 

agricultural commodities that are purchased 

by the facility as raw materials

• Applicability to food and color additives and 

substances associated with a food 

intolerance: approved suppliers control 

presence of or use of identified substances 

and ensure safe levels are not exceeded

Supply-Chain 

Program

Conduct verification activities 

appropriate to the hazard

• Sampling and testing (by supplier or receiving 

facility) to verify supplier control for chemical 

hazards such as pesticides, drug residues, 

heavy metals, and mycotoxins, when a 

supply-chain-applied control has been applied 

for such hazards 

• On-site audit to verify control of food 

allergens, such as when purchasing roasted 

almonds from a facility that handles multiple 

tree nuts

Process Controls Recipe management 

procedures as appropriate 

Facility programs to control product formulation to 

ensure that safe levels are not exceeded

Process Controls Storage conditions Control of moisture in stored raw agricultural 

commodities to prevent formation of mold

Process Controls Physical sorting Facility processing practices to sort (e.g., based 

on color, physical damage, or presence of mold) 

raw agricultural commodities to reduce levels of 

mycotoxins in processed foods

5.3.2 Considerations Applicable to Radiological Hazards

Contamination of foods by radionuclides (a radiological hazard) is a rare event. The most 

common way these radionuclides are incorporated into foods is through use of water that 

contains a radionuclide during the manufacture of a food. For example, in certain locations in 

the United States, high concentrations of radium-226, radium-228 and uranium have been 

detected in private wells (Ayotte et al., 200; Focazio et al., 2001). The most relevant information 

that would lead you to consider and evaluate a specific radiological hazard to determine 

whether it is a hazard requiring a preventive control would be publicly disseminated information 

following a particular event, such as contamination arising from accidental release from a 
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nuclear facility or from damage to a nuclear facility from a natural disaster. For example, in 

2011, radioactivity was detected in milk, vegetables and seafood produced in areas neighboring 

a nuclear power plant damaged during an earthquake and tsunami in Japan. We have issued 

guidance on levels of concern for radionuclides that could be a known or reasonably 

foreseeably hazard in certain circumstances, such as after an accident at a nuclear facility 

(FDA, 2001).

Your hazard analysis does not need to consider sources of radiation used in accordance with a 

food additive regulation. Such sources are safe for their intended use. As with any other 

equipment and substances used in the manufacture of food, you must comply with all applicable 

safety requirements established either under the terms of a food additive regulation or by an 

authority such as the Occupational Safety and Health Administration. Although the two most 

likely sources of radiological hazards that you would need to address are water used in the 

production of foods (as an ingredient or cleaning aid), and accidental contamination of your food 

product (or its ingredients) from accidental release of radionuclides from a nuclear facility, the 

PCHF requirements do not limit your responsibilities to these two sources, because we cannot

anticipate what might be a source in the future.

5.3.3 Examples of the Control of Food Allergen Hazards

Table 5-4 provides examples of the application of preventive controls to significantly minimize or 

prevent the occurrence of the ingredient-related and process-related undeclared food allergen 

hazards within finished foods. See “Chapter 11 – Food Allergen Controls” of this guidance for 

additional information on the application of food allergen controls.

Table 5-4 Application of Common Preventive Controls to Ingredient-Related and ProcessRelated Food Allergen Hazards

Preventive

Control 

Common Procedures, 

Practices, and Processes

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to 

Incorrect Product Label

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to CrossContact

Allergen 

Control –

Labelling

Perform label design and 

review during product 

development prior to 

commercialization and 

label review for each new 

batch of labels received.

Label design and review 

minimize the potential for 

the label to not identify all 

of the food allergens 

present in the food

N/A

Allergen 

Control –

Labelling

Implement procedures for 

application of correct label 

to product. 

Label application 

procedures can help 

minimize the potential for 

an incorrect label to be

applied to an allergencontaining food

N/A
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Preventive

Control 

Common Procedures, 

Practices, and Processes

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to 

Incorrect Product Label

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to CrossContact

Allergen 

Control –

Allergen 

cross-contact

Identify and mark food 

allergen-containing 

ingredients (e.g., by color 

coding or with food 

allergen icons) at 

receiving.

N/A Clearly identifying food 

allergens associated with 

raw materials or other 

ingredients simplifies 

handling practices to 

prevent allergen crosscontact

Allergen 

Control –

Allergen 

cross-contact

Segregate and store food 

allergen-containing

materials at receiving and 

warehousing.

N/A Segregation of different 

food allergens can

minimize the potential for 

allergen cross-contact

during storage

Allergen 

Control –

Allergen 

Cross-contact

Open and handle food 

allergen-containing 

ingredients at separate 

times / contain by using 

separate rooms, or by 

scheduling use of the 

same rooms at different 

times.

N/A Handling food allergens 

separately can minimize 

the potential for inadvertent 

incorporation of a food 

allergen into a product for 

which it is not an ingredient

Allergen 

Control –

Allergen 

Cross-contact

Schedule production of 

products based on food 

allergen-containing 

recipes. Schedule 

production of products that 

do not contain food 

allergens before production 

of products that do contain 

food allergens or schedule 

production of products with 

a unique food allergen last.

N/A Production scheduling can 

minimize the potential for

inadvertent incorporation of 

food allergen into a product 

for which it is not an 

ingredient

Allergen 

Control –

Allergen 

cross-contact

Physically separate 

processes for products that 

do not contain food 

allergens from products

that do contain food 

allergens or separate 

processes for products that 

do not contain the same 

food allergens

N/A Separating processes 

containing different food 

allergens can minimize the 

potential for inadvertent 

incorporation of food 

allergen into a product for 

which it is not an ingredient

Allergen 

Control –

Allergen 

cross-contact

Implement production 

procedures for rework and 

work-in-process (WIP): 

using “like into like,”

appropriate storage and 

handling, tracking

N/A Control of rework can

minimize the potential for

inadvertent incorporation of 

food allergen into a product 

for which it is not an 

ingredient
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Preventive

Control 

Common Procedures, 

Practices, and Processes

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to 

Incorrect Product Label

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to CrossContact

Sanitation

Control –

Cleaning food 

contact 

surfaces

Use full wet cleaning to 

remove food allergen 

residues prior to producing 

a product that does not 

contain that food allergen 

on the same line.

N/A Cleaning can minimize the 

presence of food allergen 

residues, preventing 

inadvertent incorporation of 

food allergen into a product 

for which it is not an 

ingredient

Sanitation 

Control –

Cross-contact

Use hygienic zoning for 

physical separation of 

process operations, 

including personnel, that 

involve foods with and 

without a specific food 

allergen

N/A Hygienic zoning can help 

prevent inadvertent 

incorporation of food 

allergen into a product for 

which it is not an ingredient 

Sanitation 

Control - 

Cross-contact

Use dedicated cleaning

utensils and equipment for 

removing food allergen 

residues from food 

processing equipment

N/A Use of dedicated cleaning 

utensils/equipment can 

prevent transfer of food 

allergen residues, thereby

preventing inadvertent 

incorporation of food 

allergen into a product for 

which it is not an ingredient

5.4 Overview of the Application of Preventive Controls for Physical 

Hazards

Table 5-5 provides an overview of the application of preventive controls to significantly minimize 

or prevent the occurrence of physical hazards in finished foods. See “Chapter 13 – Preventive 

Controls for Physical Hazards” of this guidance for further examples for the implementation of 

preventive controls for physical hazards.

Table 5-5 Applicability of Preventive Controls to Physical Hazards 

Preventive

Control 

Category

Common 

Procedures, 

Practices, and 

Processes

Applicability 

to Metal

Hazards

Applicability to Glass

Hazards (Products 

Packed in Glass)

Applicability to Other 

Hard/Sharp Physical 

Hazards

Process

Control –

Exclusion

Use screens, 

flotation tanks, 

riffle board, 

sifters, magnets, 

inversion/air to 

exclude metal 

and glass

Physically 

removes metal 

fragments 

Physically removes

glass 

Physically removes hard 

plastic, wood, stones
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Preventive

Control 

Category

Common 

Procedures, 

Practices, and 

Processes

Applicability 

to Metal

Hazards

Applicability to Glass

Hazards (Products 

Packed in Glass)

Applicability to Other 

Hard/Sharp Physical 

Hazards

Process 

Control –

Detection

Use metal or Xray detectors to 

detect and divert 

foods containing 

metal and glass

Metal and Xray detectors 

detect metal

pieces, which 

generally 

allows for 

exclusion of 

foods 

containing 

metal

X-ray detectors detect 

glass pieces, which 

generally allows for 

exclusion of foods 

containing glass

X-rays can often detect 

hazardous objects such 

as hard plastic, stones, 

bones, pits

5.5 Preventive Control Management Components

5.5.1 Overview of Preventive Control Management Components

Preventive control management components include monitoring, corrective actions and 

corrections, and verification activities (and their associated records). You must apply 

appropriate preventive control management components by considering the nature of the 

preventive control and its role in the facility’s food safety system to ensure the effectiveness of 

the preventive control. For example, monitoring may be limited for certain control measures 

such as preventive maintenance for equipment to prevent metal hazards (although you should 

have a record that the activity took place). When sanitation controls are required for 

environmental pathogens, little or no monitoring may be needed when cleaning and sanitation 

are conducted in accordance with established written protocols. Occasional verification that 

procedures are being followed may suffice. See 21 CFR 117.140.

5.5.2 Monitoring

You must establish and implement written procedures, including the frequency they are to be 

performed, for monitoring preventive controls (as appropriate to the nature of the preventive 

control and its role in your food safety system). See 21 CFR 117.145. Chapters 6 through 13 of 

this guidance provide examples of the application of preventive controls. Each of these 

chapters contains a section, “Establish Monitoring Procedures,” that provides information about 

appropriate monitoring procedures for each control strategy example discussed.

To fully describe your monitoring program, the procedures should answer four questions: (1) 

What will be monitored? (2) How will monitoring be done? (3) How often will monitoring be done 

(frequency)? and (4) Who will do the monitoring?

What you monitor should be directly related to control of the hazard. For example, for process 

controls you would monitor parameters to ensure the minimum/maximum values are met. For 

other preventive controls, you could monitor that the activity has been conducted consistent with 

a defined procedure. 
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The frequency of monitoring depends upon the circumstances. Continuous monitoring is always 

desirable, and in some cases necessary. In other cases, it may not be necessary or practical. 

You should monitor often enough that the normal variability in the values you are measuring can 

be determined and a deviation from normal will be detected. This is especially true if these 

values are typically close to the control values. Even with continuous monitoring, you should 

periodically check the paper or electronic record of the continuous monitoring to determine 

whether deviations from the control value have occurred. The frequency of that check should be 

at least daily.

If a measurement shows that a deviation from the control value has occurred, you should 

assume that the control value had not been met since the last check in which the value was 

acceptable. As a result, the greater the time span between measurements, the more products 

you are putting at risk.

You should specify in the written procedures the position of the employee who will do the 

monitoring and describe how they are to perform the monitoring procedure. See Chapters 6 

through 13 of this guidance for monitoring examples that include “who” and “how.” 

You must document your monitoring of preventive controls. See 21 CFR 117.145(c)(1). 

Although, as noted above, continuous monitoring (with associated records) is desirable, in some 

circumstances the monitoring records may be “exception records” that document loss of control. 

See 21 CFR 117.145(c)(2). 

5.5.3 Corrective Actions and Corrections

You must establish and implement corrective action procedures that would apply if preventive 

controls are not properly implemented, as appropriate to the nature of the hazard and the nature 

of the preventive control. These include corrective action procedures that must be taken if you

detect the presence of a pathogen or appropriate indicator organism in a ready-to-eat product 

as a result of product testing or if you detect the presence of an environmental pathogen or 

appropriate indicator organism through your environmental monitoring activities. See 21 CFR 

117.150(a) and (a)(1). 

A predetermined corrective action procedure has the following advantages: (1) It provides 

detailed instructions for an employee to follow in the event of a deviation in applying a 

preventive control; (2) it can be prepared at a time when an emergency situation is not calling 

for an immediate decision; and (3) it removes the obligation to reassess the food safety plan in 

response to a deviation.

Chapters 6 through 13 of this guidance provide examples of the application of preventive

controls. Each of these chapters contains a section, “Establish Corrective Action Procedures,” 

that provides information about appropriate corrective action procedures for each control 

strategy example discussed. An appropriate corrective action procedure must accomplish the 

following goals: (1) Ensure that the appropriate action is taken to identify and correct the 

problem that has occurred with the implementation of a preventive control; (2) ensure that the 

appropriate action is taken when necessary to reduce the likelihood that the problem will recur; 

(3) ensure that all affected food is evaluated for safety; and (4) ensure that all affected food is 

prevented from entering into commerce unless an evaluation has determined that the product is 

not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 342) or misbranded under 21 section 403(w) of the FD&C Act (21 U.S.C. 343(w)). See 

21 CFR 117.150(a)(2). 
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You must document your corrective actions. See 21 CFR 117.150(d). For example, when 

documenting a decision that affected product is released into commerce, your documentation 

should explain how your decision was based on sound evidence that the deviation did not 

create a food safety hazard. As another example, you should document all product dispositions, 

including dispositions to reject or destroy the product.

If you have not established a written corrective action procedure for a preventive control, you 

still must take appropriate corrective actions when an unanticipated food safety problem 

indicates that a preventive control may not have been properly implemented. See 21 CFR 

117.150(b)(1)(i). For example, you would take appropriate corrective actions if you detected a 

pathogen in a product when your production process should have controlled the pathogen. 

Although it may not be possible to anticipate all the problems that could happen, corrective 

actions need to be taken and fully documented when an unanticipated situation occurs. The 

corrective actions for the unanticipated problems would include standard corrective action 

procedures (e.g. identify and correct an implementation problem, take steps to reduce the 

likelihood it will recur, evaluate all implicated product for safety, and prevent adulterated or 

misbranded product from entering commerce). See 21 CFR 117.150(b)(2)(i). In addition when 

appropriate you must reanalyze the food safety plan (or the applicable portion of the food safety 

plan) to determine whether you need to modify the plan. See 21 CFR 117.150(b)(2)(ii). 

A correction is an action to identify and correct a problem that occurred during the production of 

food, without other actions associated with a corrective action procedure. See the definition of 

“correction” in 21 CFR 117.3. The term ‘‘correction’’ focuses on the first step in a ‘‘corrective 

action procedure’’ (i.e., identify and correct the problem). Corrections may be appropriate 

instead of corrective actions when minor, isolated problems occur that do not directly impact 

product safety. 

Here is an example of corrections vs. corrective actions. If you observe food residue on ‘‘clean’’ 

equipment prior to production, corrections would involve re-cleaning and sanitizing the 

equipment before it is used. Because you observed the food residue prior to production of food, 

and you corrected the problem in a timely manner, no food is affected and no actions are 

needed with respect to food. You are not required to record the correction because this isolated 

incident does not directly impact product safety, and you made the corrections in a timely 

manner (i.e., before the production starts). On the other hand, if you make an RTE creamed 

vegetable soup using a continuous heat exchanger and hot-fill process, and after packaging the 

soup your review of temperature records of the processed soup at the discharge end of the hold 

tube shows that the soup did not reach the temperature you identified as a critical limit, 

corrective actions would involve destroying the product, reheating it or sending it to animal food 

as appropriate,2 investigating the cause of the problem, and taking the actions needed to reduce 

the likelihood that the problem will recur based on the root cause of the problem. (Using an 

automatic flow diversion valve that diverts low-temperature product at the end of the hold tube 

back to the pre-heat kettle to be re-processed would avoid the need for taking corrective actions 

on product, although you would still investigate the cause and correct the problem.)

You must document all corrective actions in records that are subject to verification records 

review. When appropriate, you also must document corrections. See 21 CFR 117.150(d). You 

are not required to document corrections in records that are subject to verification records 

 2 For more information on sending human food to animal food use, refer to Draft Guidance for Industry: 

Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug 

Administration Amendments Act of 2007, Section III.L (FDA, 2010).
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review when the corrections are taken in a timely manner and you identify and correct a minor 

and isolated problem that does not directly impact product safety. See 21 CFR 117.150(c)(2). 

However, we recommend that you document corrections such as re-running product through a 

functioning metal detector when the one used on the production line did not reject the test 

pieces used to verify that the metal detector was operating correctly, because it provides a 

record of both the problem and the steps you took to correct the problem. If the problem recurs 

on a frequent basis, such documentation also can alert you that equipment may need to be 

repaired or replaced. We also recommend that you record corrections taken when equipment is 

adjusted because, for example, temperature does not meet an operating limit (although the 

critical limit has not been violated); such information can be useful to identify trends that indicate 

equipment repairs may be needed.

The record of corrective actions should include information on the following four elements:

First, document the actions taken to identify and correct the problem with implementation of the 

preventive control. For example, explain how you identified what went wrong with a process 

control and how you restored process control.

Second, explain what you did to reduce the likelihood that the problem will recur. Evaluation of 

historical corrective action records can help to identify recurring problems. When critical limit 

deviations frequently reoccur, the process and the Food Safety Plan may need reanalysis and 

modification. A formal process may be needed to manage major changes that need to be 

implemented. This may include reissuing forms, retraining employees, phasing in changes, 

managing label information, informing suppliers, and other tasks, depending on the nature of the 

change.

Third, explain how you evaluated the safety of all affected food. Specific technical expertise may 

be required for this evaluation, depending on the nature of the deviation. 

Fourth, explain what you did with any affected food, including identifying the amount of product 

involved and disposition of the affected product.

5.5.4 Verification

Chapters 6 through 13 of this guidance provide examples of the application of preventive

controls. Each of these chapters contains a section, “Establish Verification Procedures,” that 

provides information about appropriate verification activities for each control strategy example 

discussed. The information covers validation of the adequacy of control measure (e.g., process 

establishment); evidence that monitoring is being conducted as required; evidence that 

appropriate decisions about corrective actions are being made as required; evidence of 

verification of the implementation and effectiveness of controls (such as product testing or

environmental monitoring when appropriate); calibration of instruments, when appropriate, and 

review of records. See 21 CFR 117.155, 117.160 and 117.165. When calibration or an accuracy 

check of a preventive control monitoring instrument shows that the instrument is not accurate, 

you should evaluate the monitoring records since the last instrument calibration to determine 

whether the inaccuracy would have contributed to a deviation. For this reason, food safety plans 

with infrequent calibration or accuracy checks can place more products at risk than those with 

more frequent checks if a problem with instrument accuracy occurs.
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5.5.5 Records

Chapters 6 through 13 of this guidance provide examples of the application of preventive 

controls. Each of these chapters contains a section, “Establish a Recordkeeping System,” that 

provides information about appropriate records for each control strategy example discussed. 

Types and frequency of records vary, depending on factors such as the nature of the hazard 

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

5.6 References

Ayotte, J. D., S. M. Flanagan, and W. S. Morrow. 2007. "Occurrence of Uranium and 222Radon 

in glacial and bedrock aquifers in the northern United States, 1993-2003." U.S. 

Geological Survey Scientific Investigations Report 2007-5037. Accessed April 18, 

2016. http://pubs.usgs.gov/sir/2007/5037/. 

Cama, V. A., and Y. R. Ortega. 2014. “Cyclospora cayetanensis.” In Encyclopedia of Food 

Safety, edited by Motarjemi, Y., Moy, G., Todd, E., Elsevier.

Dawson, D. J. 2005. "Foodborne protozoan parasites." Int J Food Micro 103:201-227.

Dawson, D. J., C. M. Samuel, V. Scrannage, and C. J. Atherton. 2004. "Survival of 

Cryptosporidium species in environments relevant to foods and beverages." J Appl 

Microbiol 96 (6).

Deng, M. Q., and D. O. Cliver. 1999. "Cryptosporidium parvum studies with dairy products." Int J

Food Micro 46:113-121.

Dixon, B. R. 2014. "Protozoa: Cryptosporidium spp. ." In Encyclopedia of Food Safety, edited by 

Motarjemi, Y., Moy, G., Todd, E., 18-22. Waltham: Academic Press.

Erickson, M. C., and Y. R. Ortega. 2006. "Inactivation of protozoan parasites in food, water, and 

environmental systems." J Food Protect 69:2786-2808.

Fayer, R. 1994. "Effect of high-temperature on infectivity of Cryptosporidium parvum oocysts in 

water." Appl Environ Microb 60:2732-2735.

Fayer, R., and T. Nerad. 1996. "Effect of low temperatures on viability of Cryptosporidium 

parvum oocysts." Appl Environ Microb 62:1431-1433.

Focazio, M. J., Z. Szabo, T. F. Kraemer, A. H. Mullin, T. H. Barringer, and V. T. dePaul. 2001. 

“Occurrence of selected radionuclides in ground water used for drinking water in the 

United States: A targeted reconnaissance survey, 1998.” U.S. Geological Survey WaterResources Investigations Report 00-4273. Accessed October 14, 

2011. http://pubs.usgs.gov/wri/wri004273/pdf/wri004273.pdf.

Food and Drug Administration (FDA). 2000. "Kinetics of microbial inactivation for alternative 

food processing technologies - overarching principles: Kinetics and pathogens of 

concern for all technologies." Accessed May 31, 

2016. http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/

ucm100198.htm.
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Food and Drug Administration (FDA). 2005. "CPG Sec. 560.750 Radionucleotides in imported 

foods - levels of concern." Accessed October 14, 

2011. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo

rmation/ucm212793.htm.

Food and Drug Administration (FDA). 2010. “Draft Guidance for Industry: Questions and 

Answers Regarding the Reportable Food Registry as Established by the Food and Drug 

Administration Amendments Act of 2007,” Section III.L. Accessed August 17, 

2016. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo

rmation/ucm212793.htm.

Friedman, D. E., K. A. Patten, J. B. Rose, and M. C. Barney. 1997. "The potential for C. parvum

oocyst survival in beverages associated with contaminated tap water." J Food Safety

17:125-132.

Gamble, H. R. 2014. Trichinella spiralis and other Trichinella species. In Encyclopedia of Food 

Safety, edited by Motarjemi, Y., Moy, G., Todd, E., Elsevier.

Harp, J. A., R. Fayer, B. A. Pesch, and G. J. Jackson. 1996. "Effect of pasteurization on 

infectivity of Cryptosporidium parvum oocysts in water and milk." Appl Environ Microb

62.

Ho, A. Y., A. S. Lopez, M. G. Eberhart, R. Levenson, B. S. Finkel, and A. J. da Silva. 2002. 

"Outbreak of cyclosporiasis associated with imported raspberries, Philadelphia, 

Pennsylvania, 2000." Emerg Infect Dis 8:783-788.

Kniel, K. E., S. S. Sumner, D. S. Lindsay, C. R. Hackney, M. D. Pierson, A. M. Zajac, D. A. 

Golden, and R. Fayer. 2003. "Effect of organic acids and hydrogen peroxide on 

Cryptosporidium parvum viability in fruit juices." J Food Protect 66:1650-1657.

Korich, D. G., J. R. Mead, M. S. Madore, N. A. Sinclair, and C. R. Sterling. 1990. "Effects of 

ozone, chlorine dioxide, chlorine, and monochloramine on Cryptosporidium parvum

oocyst viability." Appl Environ Microb 56 (5):1423-1428.

Mahbubani, M. H., A. K. Bej, M. Perlin, F. W. Schaefer III, W. Jakubowski, and R. M. Atlas. 

1991. "Detection of Giardia cysts by using the polymerase chain reaction and 

distinguishing live from dead cysts." Appl Environ Microb 57:3456-3461.

Ortega, Y. R. 2013. "Chapter 28: Protozoa." In Food Microbiology - Fundamentals and 

Frontiers, edited by Doyle, M., Buchanan, R. L.

Robertson, L. J., A. T. Campbell, and H. V. Smith. 1992. "Survival of Cryptosporidium parvum

oocysts under various environmental pressures." Appl Environ Microb 58:3494-3500.

Rose, J. B., and T. R. Slifko. 1999. "Giardia, Cryptosporidium, and Cyclospora and their impact 

on foods: A review." J Food Prot 62 (1059-1070).

Slifko, T. R., E. Raghubeer, and J. B. Rose. 2000. "Effect of high hydrostatic pressure on 

Cryptosporidium parvum infectivity." J Food Prot 63 (9):1262-7.
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Sterling, C. R., and Y. R. Ortega. 1999. "Cyclospora: An enigma worth unraveling." Emerg 

Infect Dis 5 (1):48-53.

World Health Organization (WHO). 2004. Guidelines for drinking-water quality. 3rd Edition. 

Geneva, Switzerland. Accessed May 20, 

2016. http://www.who.int/water_sanitation_health/dwq/gdwq3rev/en/

and http://www.who.int/water_sanitation_health/dwq/en/waterforhealth.pdf.