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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Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 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/food-safety-modernization-act-fsma/fsma-technical-assistancenetwork-tan. 

Chapter 16: Acidified Foods 

Table of Contents

16.1 Purpose of This Chapter

16.2 Considerations to Keep in Mind If You Manufacture/Process an 

Acidified Food

16.2.1 Background on Specific Acidified Food Requirements

16.2.2 Relationship Between the Requirements in the PCHF Rule and the Specific 

Acidified Food Requirements

16.2.3 Developing a Strategy to Comply with the PCHF Rule, Emergency Permit 

Control Regulations, and Part 114

16.2.4 You Must Comply with the Specific Acidified Food Requirements Even If 

There Is No Corresponding Requirement in the PCHF Rule

16.3 Understand the Hazard Requiring a Preventive Control

16.4 Terms Used in This Chapter

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. 
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16.5 Quick Reference Guide

16.6 Requirements for Qualifications of Personnel with Responsibility for 

Supervision or Other Oversight

16.7 Requirements for Oversight

16.8 Requirements for a Written Food Safety Plan

16.9 Requirements for Hazard Analysis

16.10 Requirements for Preventive Controls

16.10.1 Identifying and Implementing Preventive Controls That Are Process 

Controls for Biological Hazards Requiring a Preventive Control

16.10.2 Preventive Controls That Have No Corresponding Requirements in 21 CFR 

108.25 or Part 114

16.10.2.1 Identifying and Implementing Preventive Controls for Chemical Hazards 

or Physical Hazards Requiring a Preventive Control

16.10.2.2 Identifying and Implementing Preventive Controls That Are Sanitation 

Controls

16.10.3 Supply-chain Controls

16.10.4 Recall Plan

16.11 Requirements for Preventive Control Management Components

16.12 Requirements for Records

16.13 Requirements for Coding

16.14 References

Appendix 16-1 Key Specific Acidified Food Requirements

16.1 Purpose of this Chapter

The guidance in this chapter is intended for persons who:

• Are subject to the PCHF requirements; and

• Manufacture, process, or pack acidified foods.

If you are subject to PCHF requirements and manufacture, process, or pack acidified foods, the 

guidance provided in this chapter is intended to explain:
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• How you can leverage procedures, practices, and processes that you establish and 

implement to comply with the requirements prescribed by 21 CFR 108.25 and 21 CFR part 

114, and records that you establish and keep to comply with those requirements, to address

corresponding requirements of the PCHF rule; and

• How you can leverage the procedures, practices, and processes that you establish and 

implement to comply with the requirements of the PCHF rule, and the records that you 

establish and keep to comply with those requirements, to address corresponding

requirements of 21 CFR 108.25 and 21 CFR part 114. 

This guidance is not intended for persons that manufacture, process, or pack acidified foods, 

but are exempt from PCHF requirements in accordance with 21 CFR 117.5(a) as a “qualified 

facility.” Qualified facilities that manufacture, process, or pack acidified foods remain subject to 

21 CFR 108.25 and part 114 and are subject to modified requirements under 21 CFR 117.201. 

16.2 Considerations to Keep in Mind If You Manufacture/Process an 

Acidified Food

16.2.1 Background on Specific Acidified Food Requirements

FDA has established specific CGMP requirements for thermally processed low-acid foods 

packaged in hermetically sealed containers (i.e., “low-acid canned foods,” or “LACF”) (21 CFR 

part 113; the LACF regulations2

) and acidified foods (21 CFR part 114 (“part 114”). In the 

proposed and final rulemakings for LACF3 and acidified foods,

4 FDA discussed the need for 

CGMP requirements to control Clostridium botulinum (C. botulinum). C. botulinum is a 

bacterium commonly found in soil. It can produce a nerve toxin (botulinum toxin) under 

anaerobic conditions such as those in canned foods. Botulinum toxin can cause botulism, a rare 

but serious paralytic illness that can be fatal and is considered a medical emergency. For 

additional information about C. botulinum and botulinum toxin, see Chapter 3 of this guidance 

and the references provided in that chapter.

Part 114 defines a scheduled process as the “process selected by a processor as adequate for 

use under the conditions of manufacture for a food in achieving and maintaining a food that will 

not permit the growth of microorganisms having public health significance. It includes control of 

pH and other critical factors equivalent to the process established by a competent processing 

authority” (21 CFR 114.3(e)). Because the pH of acidified foods is sufficiently low to prevent the 

germination of spores of C. botulinum, acidified foods may be held at ambient temperature 

without a heat treatment comparable to that required in the scheduled process for LACF (41 FR 

30442 at 30442; see 21 CFR 113.3(r)). 

2 Note that there is a partial exemption from the PCHF requirements for food subject to part 113 in 21 

CFR 117.5(d).

3 Proposed rule, 41 FR 30444, July 23, 1976; final rule, 44 FR 16209, March 16, 1979.

4 Proposed rule, 41 FR 30457, July 23, 1976; final rule, 44 FR 16230, March 16, 1979.
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FDA also has established emergency permit control requirements, under section 404 of the 

FD&C Act, for acidified foods (21 CFR 108.25; the emergency permit control regulations). FDA 

established these requirements, in part, because of the importance of controlling the pH of 

acidified foods. The emergency permit control regulations are intended to ensure safe 

manufacturing, processing, and packing processes and to permit FDA to verify that these 

processes are being followed. The emergency permit control regulations require commercial 

processors of acidified foods to register and file with FDA information, submitted on Form FDA 

2541, that includes the name of the establishment, principal place of business, location of each 

establishment in which that processing is carried on, the processing method in terms of acidity 

and pH control, and a list of foods so processed in each establishment (21 CFR 108.25(c)(1)). 

The emergency permit control regulations also require commercial processors of acidified foods 

to provide FDA with information, submitted on Form FDA 2541e, on the scheduled processes 

including, as applicable, information about the product, the container type and size, pH, method 

of acidification, microbial preservatives critical to the scheduled process, process source, 

process mode, the container and container closure treatment, and details of the scheduled 

process (e.g., process time and temperature) for each acidified food in each container size (21 

CFR 108.25(c)(2)). All plant personnel involved in acidification, pH control, heat treatment, or 

other critical factors of the operation must be under the operating supervision of a person who 

has attended a school5 approved by the Commissioner for giving instruction in food-handling 

techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, 

and critical factors in acidification, and who has satisfactorily completed the prescribed course of 

instruction (21 CFR 108.25(f)).

16.2.2 Relationship Between the Requirements in the PCHF Rule and the 

Specific Acidified Food Requirements

Some requirements of the PCHF rule have corresponding requirements in the emergency 

permit control regulations, part 114, or both, but other requirements of the PCHF rule do not. 

For example:

• The requirement of the PCHF rule for process controls for biological hazards requiring a 

preventive control has corresponding requirements for a scheduled process for an acidified 

food under the emergency permit control regulations and part 114; but

• Neither the emergency permit control regulations nor part 114 requires a hazard analysis.

Likewise, some requirements in the emergency permit control regulations, part 114, or both

have corresponding requirements in the PCHF rule, but other requirements in the emergency 

permit control regulations, part 114, or both do not. For example:

5 Often referred to as “Better Process Control School.”
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• The requirements in part 114 for frequent testing of pH, and recording the results of that 

testing, have a corresponding requirement in the PCHF rule for monitoring and for 

establishing and keeping records of monitoring; but

• The requirement of the emergency permit control regulations to submit the scheduled 

process to FDA on Form FDA 2541e has no corresponding requirement in the PCHF rule, 

and the requirement of part 114 for marking each container or product with an identifying 

code permanently visible to the naked eye has no corresponding requirement in the PCHF 

rule.

16.2.3 Developing a Strategy to Comply with the PCHF Rule, Emergency 

Permit Control Regulations, and Part 114 

Sections 16.6 through 16.13 of this chapter compare the specific requirements of the 

emergency permit control regulations, part 114, and the PCHF rule to help you comply with all 

applicable requirements by explaining:

• How you can leverage procedures, practices, and processes that you establish and 

implement to comply with the requirements prescribed by 21 CFR 108.25 and part 114, and 

records that you establish and keep to comply with those requirements, to address

corresponding requirements of the PCHF rule; and

• How you can leverage the procedures, practices, and processes that you establish and 

implement to comply with the requirements of the PCHF rule, and the records that you 

establish and keep to comply with those requirements, to address corresponding 

requirements of 21 CFR 108.25 and part 114.

Importantly, the procedures, practices, and processes that you establish and implement to 

comply with the requirements prescribed by 21 CFR 108.25 and part 114, and records that you 

establish and keep to comply with those requirements, could partially ̶but not fully ̶satisfy 

corresponding requirements of the PCHF rule. Likewise, the procedures, practices, and 

processes that you establish and implement to comply with the requirements of the PCHF rule, 

and the records that you establish and keep to comply with those requirements, could partially ̶

but not fully ̶satisfy corresponding requirements of 21 CFR 108.25 and part 114. Sections 16.6 

through 16.13 of this chapter provide details about the extent to which complying with the 

requirements prescribed by 21 CFR 108.25 and part 114 can address the corresponding PCHF 

requirements and vice versa.

In some cases, the simplest approach to complying with both sets of requirements could be to 

use procedures, practices, processes, or records associated with the specific acidified food

requirements to address the corresponding requirements of the PCHF rule. For example, see 

the discussion in section 16.10.1 regarding process controls. Because process controls for 

acidified foods must address all parameters specified on Form FDA 2541e, a simple approach 

to complying with the requirement to identify and implement preventive controls that are process 

controls could be to complete Form FDA 2541e and include it in your food safety plan as a 

written process control. 
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In other cases, the simplest approach to complying with both sets of requirements could be to 

use procedures, practices, processes, or records associated with the specific requirements of

the PCHF rule to address the corresponding requirements specific to acidified foods. For 

examples, see the discussions in:

• Section 16.10.4 regarding the recall plan required by the PCHF rule for foods with hazards 

that require a preventive control and the recall procedures required by 21 CFR 108.25(e);

• Section 16.11 regarding preventive control management components required by the PCHF 

rule and corresponding requirements in part 114; and

• Section 16.12 regarding the recordkeeping requirements of part 117 and the corresponding 

recordkeeping requirements of part 114. 

This chapter provides you with information to help you choose an approach for complying with 

the PCHF rule, emergency permit control regulations, and part 114, in a way that works best for 

your facility and your acidified food product. 

16.2.4 You Must Comply with the Specific Acidified Food Requirements Even If 

There Is No Corresponding Requirement in the PCHF Rule

Appendix 16-1 in this chapter summarizes key specific acidified food requirements under the 

emergency permit control regulations, part 114, or both that either:

• Have no explicitly corresponding requirement under the PCHF rule; or

• Exceed the corresponding requirements of the PCHF rule. 

Sections 16.6 through 16.13 of this chapter provide suggestions for how you can address some

of the key specific acidified food requirements (see Appendix 16-1) by complying with the PCHF 

rule. For example, part 114 requires that the scheduled process for an acidified food control 

microorganisms of non-health significance in addition to pathogens (see 21 CFR 114.80(a)(1) 

and Appendix 16-1), and section 16.9 explains how your hazard analysis could identify 

microorganisms of non-health significance as a biological hazard requiring a preventive control, 

even though microorganisms of non-health significance, by themselves, are not “hazards” as 

that term is defined in part 117. However, sections 16.6 through 16.13 of this chapter also clarify 

that none of the PCHF requirements address the submission of a food canning establishment 

registration on Form FDA 2541 as required by 21 CFR 108.25(c)(1) or suggest any way to 

comply with the requirement to submit Form FDA 2541e other than the mechanism specified in 

21 CFR 108.25(c)(2).

If a specific acidified food requirement exceeds the corresponding requirement of the PCHF 

rule, you must comply with the specific acidified food requirement. As discussed in section 

16.12, part 114 requires that you keep records required by part 114 for 3 years, which exceeds 

the 2-year record retention requirement in part 117 for records documenting the food safety plan 

and implementation of the food safety plan. (See 21 CFR 114.100(e) and 21 CFR 117.315.) 
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16.3 Understand the Hazard Requiring a Preventive Control

The PCHF rule requires a hazard analysis to determine whether there are any hazards requiring 

a preventive control. (See 21 CFR 117.130(a)(1).) Part 114 includes requirements to control 

hazards associated with C. botulinum and other microorganisms of public health significance. 

Thus, understanding the hazards that can be controlled by complying with part 114 can help to 

understand which known or reasonably foreseeable (potential) hazards require a preventive 

control under the PCHF rule. Below, we discuss the hazards that part 114 controls, as well as 

the importance of controlling some microorganisms of non-health significance6 (which are not 

“hazards” as that term is defined in part 117). 

When conditions are not conducive to growth of vegetative cells (e.g., when the availability of 

nutrients is limited), C. botulinum can form spores that are adapted for prolonged survival under 

adverse conditions (Larousse and Brown, 1997). Thermal processes using temperatures such 

as 212 °F (100°C) (i.e., the temperature of boiling water) or even lower (e.g., 150 °F (65.6°C) in 

some circumstances) can destroy the vegetative cells of C. botulinum, but do not destroy the 

spores of C. botulinum (see 41 FR 30442 at 30442, July 23, 1976). 

When the pH of a food is 4.6 or below, spores of C. botulinum will not germinate and grow (41 

FR 30442 at 30442). However, an acidified food can pose a risk of botulism if pH and other 

critical factors are not carefully controlled during processing to prevent the germination and 

growth of viable spores of C. botulinum (44 FR 16204 at 16204, March 16, 1979). When critical 

factors are not carefully controlled, the vegetative cells of some microorganisms of non-health 

significance (such as some spoilage bacteria, yeasts, and molds) can grow in an acid 

environment and, in so doing, cause the pH of the food to increase (Fields, Zamora, and 

Bradsher, 1977; Odlaug and Pflug, 1978; and Institute of Food Technologists, 2001). In 

addition, some spoilage microorganisms (such as Bacillus licheniformis (B. licheniformis)) 

produce heat-resistant, acid-tolerant spores that, when critical factors are not properly 

controlled, can germinate, grow, and cause the pH to increase; thermal processing that is 

sufficient to destroy vegetative cells of such microorganisms may not be sufficient to destroy 

their spores (Fields, Zamora, and Bradsher, 1977; Montville, 1982; Al Dujaili and Anderson, 

1991; and Rodriguez, Cousin, and Nelson, 1992). 

16.4 Terms Used in This Chapter

Section III.B in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance but are not defined in 21 CFR 117.3. At this time, that glossary does not include 

all terms that are used in this chapter. See Table 16-1 for additional terms that we use in this 

chapter. We intend to include these terms in the glossary in the Introduction of this guidance 

when we update the Introduction. When we do so, we will delete Table 16-1 from this chapter.

6 See section 16.9 for additional discussion of microorganisms of non-health significance.
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Table 16-1 Terms Used in this Chapter

Term What the Term Means

Emergency permit control 

regulations

Emergency permit control requirements in 21 CFR 108.25 for acidified 

foods

Part 114 Requirements in 21 CFR part 114, Acidified Foods

Potential hazard Known or reasonably foreseeable hazard (which is defined in 21 CFR 

117.3)

16.5 Quick Reference Guide 

Table 16-2 is a quick reference guide to help you see at a glance the relationship between the 

specific acidified food requirements and corresponding PCHF requirements. 

Table 16-2 Quick Reference Guide Listing the Specific Acidified Food Requirements and 

Corresponding PCHF Requirements

Description of Requirement Applicable 

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

Applicable 

Requirements in Part 

117 (21 CFR)

Applicable 

Section in This 

Chapter

Applicable 

Chapters in This 

Guidance

Qualifications of personnel with 

responsibility for supervision or 

other oversight

• 108.25(f)

• 114.10

• 117.4(c) 

• 117.180(c)(1)

16.6 N/A

Oversight • 108.25(f)

• 114.10

• 114.83

• 117.126(a)(2)

• 117.160(b)(1)

• 117.160(c)(5)

• 117.165(a)(4)

• 117.170(c)(2)(ii)

• 117.180(a)

16.7 Chapter 1

Written food safety plan N/A 117.126 16.8 Chapter 1

Hazard analysis N/A 117.130 16.9 • Chapters 2, 3, 

and 6 

• Appendix 1

• Appendix 3
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Description of Requirement Applicable 

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

Applicable 

Requirements in Part 

117 (21 CFR)

Applicable 

Section in This 

Chapter

Applicable 

Chapters in This 

Guidance

Identifying and implementing 

preventive controls that are 

process controls for biological 

hazards requiring a preventive 

control

• 108.25(c)(2)

• 108.25(c)(3)

• 114.80(a)(1)

• 114.80(a)(3)

• 114.80(a)(4)

• 117.126(b)(2)

• 117.135(a)

• 117.135(b)

• 117.135(c)(1)

16.10.1 Chapters 4 and 6 

Identifying and implementing 

preventive controls for chemical 

or physical hazards requiring a 

preventive control

N/A • 117.126(b)(2)

• 117.135(a)

• 117.135(b)

• 117.135(c)(1)

• 117.135(c)(2)

16.10.2.1 Chapters 4, 11, 

12, and 13

Identifying and implementing 

preventive controls that are 

sanitation controls

N/A • 117.126(b)(2)

• 117.135(a)

• 117.135(b)

• 117.135(c)(3)

16.10.2.2 Chapter 10

Supply-chain controls 114.100(a) • 117.126(b)(3)

• 117.135(a)

• 117.135(c)(4)

• Subpart G

16.10.3 Chapters 4 and 

15

Recall plan 108.25(e) • 117.126(b)(4)

• 117.135(a)

• 117.135(b)

• 117.135(c)(5)

• 117.139

16.10.4 Chapters 4 and 

14

Preventive control management 

components

• 108.25(c)(3)(ii)

• 114.3

• 114.80(a)(2)

• 114.80(a)(4)

• 114.89

• 114.90

• 117.126(b)(5)

• 117.126(b)(6)

• 117.126(b)(7)

• 117.140

• 117.145

• 117.150

• 117.155

• 117.160

• 117.165

16.11 Chapters 5 and 6
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Description of Requirement Applicable 

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

Applicable 

Requirements in Part 

117 (21 CFR)

Applicable 

Section in This 

Chapter

Applicable 

Chapters in This 

Guidance

Records • 108.25(g)

• 114.100

• 117.9

• 117.126(c)

• 117.145(c)

• 117.150(d)

• 117.155(b)

• 117.180(d)

• 117.190(a)

• 117.475(c)

• Subpart F

16.12 Chapter 6

Coding 114.80(b) N/A 16.13 N/A

16.6 Requirements for Qualifications of Personnel with 

Responsibility for Supervision or Other Oversight

Part 117 includes requirements for qualifications of personnel, including supervisory personnel 

(see 21 CFR 117.4). Table 16-3 shows how you can leverage compliance with corresponding 

training requirements in 21 CFR 108.25(f) and 114.10 to address the requirement of 21 CFR 

117.4(c) to provide supervisory oversight for the production of an acidified food product. Note 

that, in general, satisfying the training requirements of 21 CFR 117.4 would not satisfy the 

specialized training requirements of 21 CFR 108.25(f) and 114.10. 
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Table 16-3 Qualifications of Personnel with Responsibility for Supervision or Other 

Oversight 

Requirements in Part 117

(21 CFR)

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR

108.25 or Part 114 to 

Address Requirements in 

Part 117

117.4(c): Responsibility for ensuring 

compliance by individuals with the 

requirements of this part must be clearly 

assigned to supervisory personnel who 

have the education, training, or 

experience (or a combination thereof) 

necessary to supervise the production 

of clean and safe food.

108.25(f) and 114.10: All 

operators of processing 

and packaging systems 

shall be under the 

operating supervision of a 

person who has attended a 

school approved by the 

Commissioner for giving 

instruction in food-handling 

techniques, food-protection 

principles, personal 

hygiene and plant 

sanitation practices, pH 

controls and critical factors 

in acidification, and who 

has been identified by that 

school as having 

satisfactorily completed the 

prescribed course of 

instruction.

Satisfactorily completing the 

prescribed course of instruction in a 

school specified in 21 CFR 108.25(f) 

and 114.10 provides an individual 

with the qualifications necessary to

provide supervisory oversight for the 

production of an acidified food 

product as required by 21 CFR

117.4(c). 

16.7 Requirements for Oversight 

The PCHF rule requires preparation or oversight of the food safety plan, and performance or 

oversight of implementation of certain activities related to the food safety plan, by one or more 

PCQIs. (See 21 CFR 117.126(a)(2) and 117.180(a).) Table 16-4 shows how you can leverage 

compliance with corresponding requirements in 21 CFR 108.25(f), 114.10, and 114.83 to 

address these requirements of the PCHF rule as they relate to acidification. 

See Appendix 16-1 in this chapter and the discussion in section 16.6 regarding the specialized 

training requirements of 21 CFR 108.25(f) and 114.10 for supervisory oversight of processing 

and packaging of acidified foods. In general, a person who satisfies the qualification 

requirements of the PCHF rule for a PCQI to prepare, or oversee the preparation of, the food 

safety plan and to conduct or oversee activities listed in 21 CFR 117.180(a) would not be 

qualified to supervise the processing and packaging of acidified foods unless that person also 

satisfies the specialized training requirements of 21 CFR 108.25(f) and 114.10.
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Table 16-4 Requirements for Oversight 

Requirements in Part 

117

(21 CFR)

Requirements in 21 CFR

108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR

108.25 or Part 114 to Address 

Requirements in Part 117

• 117.126(a)(2): The food 

safety plan must be 

prepared, or its preparation 

overseen, by one or more 

preventive controls qualified 

individuals.

• 117.180(a): One or more 

preventive controls qualified 

individuals must do or 

oversee certain activities

related to preparation and 

implementation of the food 

safety plan: 

o 117.160(b)(1)

(validation of preventive 

controls)

o 117.160(b)(1)(i)(B)(2) 

(justification for a 

validation timeframe that 

exceeds the first 90 

days of production) 

o 117.160(c)(5)

(justification that 

validation is not

applicable) 

o 117.165(a)(4) (review of 

records) 

o 117.165(a)(4)(i) 

(justification for a 

timeframe that exceeds 

7 days for review of 

certain records) 

o 117.170(c)(2)(ii)

(justification for the 

timeframe for 

completion of the 

reanalysis, and 

validation of additional 

preventive controls, if 

the timeframe exceeds 

90 days after 

production) 

• 108.25(f) and 114.10: All 

operators of processing and 

packaging systems shall be 

under the operating supervision 

of a person who has attended a 

school approved by the 

Commissioner for giving 

instruction in food-handling 

techniques, food-protection 

principles, personal hygiene 

and plant sanitation practices, 

pH controls and critical factors 

in acidification, and who has 

been identified by that school 

as having satisfactorily 

completed the prescribed 

course of instruction.

• 114.83 The scheduled process 

shall be established by a 

qualified person who has 

expert knowledge acquired 

through appropriate training 

and experience in the 

acidification and processing of 

acidified foods. Under 114.3(e), 

scheduled process means the 

process selected by a 

processor as adequate for use 

under the conditions of 

manufacture for a food in 

achieving and maintaining a

food that will not permit the 

growth of microorganisms 

having public health 

significance. It includes control 

of pH and other critical factors 

equivalent to the process 

established by a competent 

processing authority.

• A person who satisfactorily completes

the prescribed course of instruction 

specified in 21 CFR 108.25(f) and

114.10 could, through job experience, 

be qualified to conduct or oversee the 

following activities listed in 21 CFR

117.180(a) as they relate to 

acidification: 

o Review of records (21 CFR 

117.165(a)(4); and

o Justification for a timeframe that 

exceeds 7 days for review of 

certain records (21 CFR 

117.165(a)(4)(i))

• A person who is a competent 

processing authority and who 

establishes the scheduled process in 

accordance with 21 CFR 114.83 

could, through job experience, be 

qualified to conduct or oversee the 

following activities listed in 21 CFR 

117.180(a) as they relate to 

acidification and thermal processing 

of an acidified food: 

o 117.160(b)(1) (validation of 

preventive controls)

o 117.160(b)(1)(i)(B)(2) 

(justification for a validation 

timeframe that exceeds the first 

90 days of production)

o 117.160(c)(5) (justification that 

validation is not applicable)

o 117.165(a)(4) (review of records)

o 117.165(a)(4)(i) (justification for a 

timeframe that exceeds 7 days 

for review of certain records) 

o 117.170(c)(2)(ii) (justification for 

the timeframe for completion of 

the reanalysis, and validation of 

additional preventive controls, if 

the timeframe exceeds 90 days 

after production)
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16.8 Requirements for a Written Food Safety Plan

The PCHF rule requires that you prepare, or have prepared, and implement a written food 

safety plan (see 21 CFR 117.126). Neither 21 CFR 108.25 nor part 114 has a corresponding 

requirement to prepare, or have prepared, and implement a written food safety plan. However, 

in the remainder of this chapter we explain how you can leverage procedures, practices, and 

processes that you establish and implement to comply with the requirements of 21 CFR 108.25 

or part 114, and records that you establish and keep to comply with those requirements, to 

address requirements of the PCHF rule for a food safety plan.

16.9 Requirements for Hazard Analysis 

Part 117 defines hazard as any biological, chemical (including radiological), or physical agent 

that has the potential to cause illness or injury. (See 21 CFR 117.3.) The PCHF rule includes 

requirements:

• To conduct a hazard analysis, which must be written regardless of its outcome (see 21 CFR 

117.130(a));

• For a hazard identification that considers known or reasonably foreseeable hazards that 

include biological hazards, chemical hazards, and physical hazards, regardless of whether 

the hazard occurs naturally, is unintentionally introduced, or is intentionally introduced for 

purposes of economic gain (see 21 CFR 117.130(b)); and

• Applicable to the hazard evaluation (see 21 CFR 117.130(c)).

Neither 21 CFR 108.25 nor part 114 has a corresponding requirement for any requirement of 

the PCHF rule for hazard analysis. However, 21 CFR 108.25 and part 114 require specific 

controls for the biological hazard C. botulinum, monitoring of one of those controls (i.e., pH), and 

a basis for the adequacy of the process. (See 21 CFR 114.80(a)(1) and (2) and 21 CFR 

108.25(c)(3)(ii), respectively.) In addition, part 114 requires thermal processing to an extent that 

is sufficient to destroy the vegetative cells of microorganisms of public health significance. (See 

21 CFR 114.80(a)(1).) 

A hazard analysis that identifies and evaluates C. botulinum as a biological hazard requiring a 

preventive control can lead to appropriate preventive controls and associated preventive control 

management components that could address the corresponding requirements of part 114 as 

they relate to the biological hazard C. botulinum. In addition, a hazard analysis that identifies 

microorganisms (other than C. botulinum) of public health significance can lead to appropriate 

preventive controls and associated preventive control management components that could 

address the corresponding requirements of part 114 as they relate to the vegetative cells of 

microorganisms of public health significance other than C. botulinum. For example:

• As discussed in section 16.2.1, in the proposed and final rulemakings for LACF and acidified 

foods FDA discussed the need for CGMP requirements to control C. botulinum. Under part 
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Chapter 16 (Acidified Foods) - Page 14

117, a knowledgeable person would identify C. botulinum as a biological hazard requiring a 

preventive control to inactivate vegetative cells of C. botulinum and to prevent toxin 

formation due to germination and growth from spores of C. botulinum. A hazard analysis

could reference 21 CFR 108.25 and part 114, rather than citations to published scientific 

literature, as the basis for a conclusion that C. botulinum in shelf-stable acidified foods is a 

hazard requiring a preventive control. 

• Part 114 requires that acidified foods be thermally processed to an extent that is sufficient to 

destroy the vegetative cells of microorganisms of public health significance. (See 21 CFR 

114.80(a)(1).) Under part 117, a knowledgeable person could identify pathogenic bacteria 

such as Salmonella, Escherichia coli (E. coli) O157:H7 and Listeria monocytogenes (L. 

monocytogenes) as hazards associated with some acidified foods because these 

pathogenic bacteria can be present on some of the ingredients and can be a hazard if the 

heat treatment is not adequate to kill vegetative cells of the pathogenic bacteria. (See 

Appendix 1 of this guidance and the example of the heat processing for a salsa in Chapter 6

of this guidance.) 

• Part 114 requires that the scheduled process for an acidified food control microorganisms of 

non-health significance in addition to pathogens. (See 21 CFR 114.80(a)(1) and Appendix 

16-1.) Microorganisms of non-health significance, by themselves, are not “hazards” as that 

term is defined in part 117. However, as discussed in section 16.3, when critical factors are 

not carefully controlled, the vegetative cells of some microorganisms of non-health 

significance (such as some spoilage bacteria) can grow in an acid environment and, in so 

doing, cause the pH of the food to increase. Therefore, under part 117, a knowledgeable 

person could identify microorganisms of non-health significance in shelf-stable acidified 

foods as biological hazards requiring a preventive control. 

• The parameters that you submit to us on Form FDA 2541e address critical factors such as 

control of pH, process time and temperature, and preservatives. (See Form 2541e and 21 

CFR 114.80(a)(1).) As discussed in section 16.10.1, identifying pathogenic bacteria such as

C. botulinum, Salmonella, E. coli O157:H7, and L. monocytogenes as biological hazards

requiring a preventive control, and identifying microorganisms of non-health significance in 

shelf-stable acidified foods as biological hazards requiring a preventive control, could lead to 

identifying the parameters that you submit to us on Form FDA 2541e as the preventive 

controls. As discussed in section 16.11, these parameters for process controls could lead to 

preventive control management components (such as monitoring pH, and verification that 

includes validation to establish the adequacy of the process) to address the requirement of 

21 CFR 114.80(a)(2) for monitoring pH and the requirement of 21 CFR 108.25(c)(3)(ii) for 

adequacy of the scheduled process.

7

• Part 114 requires that testing and examination of containers shall occur often enough to 

ensure that the container suitably protects the food from leakage or contamination because 

there is a potential for recontamination with microorganisms (including pathogens and 

microorganisms of non-health significance that could raise the pH) if there is a loss of 

seam/seal integrity, especially during cooling of the sealed containers in water. (See 21 CFR 

114.80(a)(4).) The hazard evaluation must consider the effect of packaging activities on the 

7 Although not specified in part 114, preventive control management components for acidified foods 

generally would include monitoring the thermal process and other critical factors in addition to monitoring 

pH, and verification activities in addition to validation. See Section 6.16 in Chapter 6 of this for a 

comprehensive example of preventive control management components for an acidified food. 
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safety of the finished food for the intended consumer. (See 21 CFR 117.130(c)(2)(vi).) A 

knowledgeable person would identify microorganisms (including pathogens and 

microorganisms of non-health significance that could raise the pH) that could recontaminate

the food due to lack of container integrity as process-related biological hazards requiring a 

preventive control. As discussed in section 16.10.1, this outcome of the hazard analysis 

could lead to a preventive control during seaming/sealing after filling the container (i.e., 

applying a hermetic seal) to prevent recontamination. As discussed in section 16.11, this 

preventive control could lead to preventive control management components that include 

monitoring of seam/seal integrity to address the requirements of 21 CFR 114.80(a)(4).

For help in identifying other known or reasonably foreseeable biological, chemical, or physical 

hazards applicable to your product, see: 

• Chapter 2 of this guidance regarding the hazard analysis; 

• Chapter 3 of this guidance regarding hazards associated with the manufacturing, 

processing, packing, and holding of human food; 

• Appendix 1 of this guidance regarding known or reasonably foreseeable (potential) hazards 

and 

• Section 6.16 in Chapter 6 of this guidance regarding heat treatments as a process control, 

which provides an example of a hazard analysis for a salsa. In this example, a salsa 

manufacturer identified Salmonella, E. coli O157:H7, L. monocytogenes, and C. botulinum

as hazards associated with the salsa because these pathogenic bacteria can be present on 

some of the ingredients and can be a hazard if the salsa is not properly acidified to a pH that 

is low enough to prevent the germination of spores of C. botulinum and if the heat treatment 

is not adequate to kill vegetative cells of the pathogenic bacteria. In addition, the salsa 

manufacturer consulted the scientific literature and found that sporeforming bacteria that are 

generally associated with spoilage (such as Bacillus subtilis and B. licheniformis) could 

affect the safety of an acidified food if spores that are not destroyed during the product heat 

treatment germinate, grow, and cause the pH to increase above 4.6. 

16.10 Requirements for Preventive Controls

The PCHF rule includes requirements to identify and implement preventive controls to provide 

assurances that any hazards requiring a preventive control will be significantly minimized or 

prevented and the food manufactured, processed, packed, or held by your facility will not be 

adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the 

FD&C Act. (See 21 CFR 117.135(a).) Preventive controls must be written. (See 21 CFR 

117.135(b).)
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16.10.1 Identifying and Implementing Preventive Controls that Are Process 

Controls for Biological Hazards Requiring a Preventive Control

Table 16-5 shows how you can leverage the parameters that you submit on Form FDA 2541e to 

address the requirements of the PCHF rule for written preventive controls that are process 

controls for biological hazards requiring a preventive control. For example, Form FDA 2541e 

requires information about pH, process time and temperature, and preservatives.8

See Appendix 16-1 in this chapter for key additional requirements specific to acidified foods. 

Table 16-5 also shows how, with some limitations, you can leverage written process controls 

that you identify and implement for acidification to comply with the requirements of the PCHF 

rule to address the corresponding requirements in part 114 and Form FDA 2541e (e.g., for 

control of pH, process time and temperature, and preservatives). However, the requirement in 

21 CFR 108.25(c)(2) to submit Form FDA 2541e to FDA has no corresponding requirement in 

the PCHF rule. You must submit Form FDA 2541e to FDA as required by 21 CFR 108.25(c)(2)

even if you include Form FDA 2541e in your food safety plan. 

As discussed in section 16.9, one outcome of the hazard analysis could be a preventive control 

during seaming/sealing after filling the container (i.e., applying a hermetic seal) to prevent 

recontamination. Although this preventive control has no directly corresponding requirement in 

21 CFR 108.25(e) or part 114, there is a related requirement specific to acidified foods. As 

shown in Appendix 16-1 in this chapter, part 114 requires testing and examination of containers 

at a frequency that is often enough to ensure that the container suitably protects the food from 

leakage or contamination. (See 21 CFR 114.80(a)(4).) See the discussion in section 16.11 of 

how the requirement of part 114 for testing and examination of containers at a frequency that is 

often enough to ensure that the container suitably protects the food from leakage or 

contamination could satisfy the requirements of the PCHF rule for monitoring of seam/seal 

integrity as a preventive control management component for a process control of applying a 

hermetic seal.

For additional help regarding the requirements of the PCHF rule for process controls for 

biological hazards requiring a preventive control, see:

• Chapter 4 regarding preventive controls; and 

• Section 6.16 in Chapter 6 (regarding heat treatments as a process control), which provides 

an example of process controls for a salsa. 

8 Note that you must include your process controls in the food safety plan that you keep onsite even 

though you submit them to FDA on Form FDA 2541e, because the food safety plan must be kept onsite 

(see 21 CFR 117.315(d)). 
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Table 16-5 Identifying and Implementing Preventive Controls that Are Process Controls 

for Biological Hazards Requiring a Preventive Control

Requirements in Part 117

(21 CFR)

Corresponding Requirements in 21 

CFR 108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 

CFR 108.25 or Part 114 

to Address 

Corresponding 

Requirements in the 

PCHF Rule

How You Can 

Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to 

Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part 

114

• Requirements to identify 

and implement 

preventive controls that 

are process controls:

o 117.135(a) (general 

requirement)

o 117.135(c)(1) Process 

controls. Process 

controls include 

procedures, practices, 

and processes to 

ensure the control of 

parameters during 

operations such as 

heat processing, 

acidifying, irradiating, 

and refrigerating 

foods. Process 

controls must include, 

as appropriate to the 

nature of the 

applicable control and 

its role in the facility’s 

food safety system: (i) 

Parameters associated 

with the control of the 

hazard; and (ii) The 

maximum or minimum 

value, or combination 

of values, to which any 

biological, chemical, or 

physical parameter 

must be controlled to 

significantly minimize 

or prevent a hazard 

requiring a process 

control.

• Requirement for written 

procedures for 

preventive controls that 

are process controls:

o 117.126(b)(2)

o 117.135(b)

• 108.25(c)(2): Requires the 

submission to FDA of Form FDA 

2541e. Form FDA 2541e requires, as 

applicable, information about the 

product, the container type and size, 

pH, method of acidification, microbial 

preservatives critical to the scheduled 

process, process source, process 

mode, the container and container 

closure treatment, and details of the 

scheduled process (e.g., process time 

and temperature), for each acidified 

food in each container size.

• 108.25(c)(3): Requires a commercial 

processor engaged in processing 

acidified foods to process each food 

in conformity with at least the 

scheduled processes filed under 21 

CFR 108.25(c)(2).

• 114.80(a)(1): Acidified foods shall be 

so manufactured, processed, and 

packaged that a finished equilibrium 

pH value of 4.6 or lower is achieved 

within the time designated in the 

scheduled process and maintained in 

all finished foods. Manufacturing shall 

be in accordance with the scheduled 

process. Acidified foods shall be 

thermally processed to an extent that 

is sufficient to destroy the vegetative 

cells of microorganisms of public 

health significance and those of nonhealth significance capable of 

reproducing in the food under the 

conditions in which the food is stored, 

distributed, retailed and held by the 

user. Permitted preservatives may be 

used to inhibit reproduction of 

microorganisms of non-health 

significance (in lieu of thermal 

processing).

• 114.80(a)(3): Lists acceptable 

procedures for acidification to attain 

acceptable equilibrium pH levels in 

the final food

• The parameters that 

you establish in 

accordance with 21 

CFR 114.80(a)(1) and 

submit on Form FDA 

2541e could satisfy 

the requirement for 

parameters associated 

with control of a 

hazard for process 

controls, and 

applicable maximum 

or minimum values in 

21 CFR 117.135(c)(1), 

as long as you include 

that scheduled 

process in the food 

safety plan that is 

signed and dated by 

the owner, operator, or 

agent in charge of the 

facility and kept onsite 

(see 21 CFR 117.310 

and 117.315(c)). 

• Compliance with the 

scheduled process 

submitted to FDA on 

Form FDA 2541e 

could satisfy the 

requirements in 21 

CFR 117.135(a) and 

(c) to implement 

preventive controls 

that are process 

controls for biological 

hazards that require a 

preventive control.

Complying with the 

PCHF requirements 

to identify and 

implement process 

controls, parameters 

associated with 

control of the hazard, 

and applicable 

maximum or 

minimum values that 

satisfy all 

requirements in 21 

CFR 114.80(a)(1) 

and all requirements 

on Form FDA 2541e 

could satisfy all 

requirements of 21 

CFR 108.25(c)(2) and 

(3) and part 114 (e.g., 

for control of pH, 

process time and 

temperature, and

preservatives), as 

long as you also 

submit Form FDA 

2541e to FDA. 
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16.10.2 Preventive Controls That Have No Corresponding Requirements 

in 21 CFR 108.25 or Part 114

As discussed in sections 16.10.2.1 and 16.10.2.2, the PCHF rule specifies some preventive 

control requirements that have no corresponding requirements in either 21 CFR 108.25 or part 

114.

16.10.2.1 Identifying and Implementing Preventive Controls for Chemical 

Hazards or Physical Hazards Requiring a Preventive Control 

When the hazard requiring a preventive control under part 117 is a chemical or physical hazard, 

neither 21 CFR 108.25 nor part 114 has a corresponding requirement to identify and implement 

a preventive control. Preventive controls for chemical or physical hazards could be a process 

control (see 21 CFR 117.135(c)(1)) or, in the case of a chemical hazard that is a food allergen 

hazard, a food allergen control (see 21 CFR 117.135(c)(2)).

For help in identifying and implementing preventive controls for known or reasonably 

foreseeable chemical and physical hazards applicable to acidified foods, see:

• Chapter 4 regarding preventive controls; 

• Chapter 11 regarding food allergen controls; 

• Chapter 12 regarding preventive controls for chemical hazards; and

• Chapter 13 regarding preventive controls for physical hazards.

16.10.2.2 Identifying and Implementing Preventive Controls That Are 

Sanitation Controls

Sanitation controls include procedures, practices, and processes to ensure that the facility is 

maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as 

environmental pathogens, biological hazards due to employee handling, and food allergen 

hazards. Sanitation controls must include, as appropriate to the facility and the food, 

procedures, practices, and processes for the: (1) Cleanliness of food-contact surfaces, including 

food-contact surfaces of utensils and equipment; and (2) prevention of allergen cross-contact 

and cross-contamination from insanitary objects and from personnel to food, food packaging 

material, and other food-contact surfaces and from raw product to processed product. (See 21 

CFR 117.135(c)(3).) Neither 21 CFR 108.25 nor part 114 has a corresponding requirement to 

identify and implement a sanitation control. 

Complying with part 114 should make it unnecessary to identify and implement sanitation 

controls for the control of environmental pathogens (such as L. monocytogenes or Salmonella) 

for many acidified foods because part 114 requires thermal processing to an extent that is 
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sufficient to destroy the vegetative cells of microorganisms of public health significance (see 21 

CFR 114.80(a)) and because many acidified foods are packaged (e.g., by hot filling) in a way 

that does not expose the thermally processed food to the environment at a temperature at which 

environmental pathogens would survive the filling. However, as part of the hazard analysis the 

PCQI would evaluate whether sanitation controls for the control of environmental pathogens are 

necessary if a ready-to-eat acidified food is exposed to the environment prior to packaging and 

the packaged food does not receive a treatment or otherwise include a control measure (such 

as a formulation lethal to the environmental pathogen) that would significantly minimize the 

environmental pathogen. (See 21 CFR 117.130(c)(1)(ii).)

Sanitation controls are one way to address food allergen hazards. You determine through your 

hazard analysis whether food allergen hazards require sanitation controls (which can also be 

considered food allergen controls, because sanitation controls are procedures to protect food 

from allergen cross-contact). 

For help in determining whether to identify and implement sanitation controls, see:

• Chapter 4 regarding preventive controls; and 

• Chapter 10 regarding sanitation controls. 

16.10.3 Supply-chain Controls

The PCHF rule requires that a receiving facility establish and implement a risk-based supplychain program for those raw materials and other ingredients for which the receiving facility has 

identified a hazard requiring a supply-chain-applied control. (See subpart G and 21 CFR 

117.405(a)(1).) Supply-chain controls are not required if the receiving facility (rather than a 

supplier) will control a hazard requiring a preventive control. For example, supply-chain controls 

are not required for biological hazards that are controlled by the process controls for an acidified 

food.

Part 114 requires that records shall be maintained of suppliers' guarantees or certifications that 

verify compliance with FDA regulations and guidance documents or action levels. (See 21 CFR

114.100(a).) If your hazard analysis for a raw material or other ingredient identifies any hazards 

requiring a supply-chain-applied control, and your supply-chain program for that raw material or 

other ingredient includes sampling and testing of that raw material or other ingredient with 

results reported in documentation such as a Certificate of Analysis, complying with the 

requirements for supply-chain controls could satisfy the corresponding requirement of 21 CFR 

114.100(a) for records of suppliers’ guarantees or certifications. (See 21 CFR 117.410(b)(2) 

(which identifies sampling and testing of raw materials or other ingredients as an appropriate 

supplier verification activity) and 21 CFR 117.475(c)(8) (which requires documentation of 

sampling and testing conducted as a supplier verification activity)).
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For help in determining whether to establish and implement a supply-chain program, see:

• Chapter 4 regarding preventive controls; and

• Chapter 15 regarding a supply-chain program.

16.10.4 Recall Plan

The PCHF rule requires a recall plan for food with a hazard requiring a preventive control. (See 

21 CFR 117.139.) Table 16-6 shows how you can leverage procedures, practices, and 

processes that you establish and implement to comply with corresponding requirements in 21 

CFR 108.25(e) to address the requirements of the PCHF rule for a recall plan. 

Table 16-6 also shows how, with one limitation, you can leverage a written recall plan that you 

establish and implement to comply with the requirements of the PCHF rule to address the 

corresponding requirements in 21 CFR 108.25(e) regarding recalls. However, the requirement 

in 21 CFR 108.25(e) for the recall procedures to include notifying FDA of any recalls has no 

corresponding requirement in the PCHF rule for a recall plan. Therefore, a written recall plan 

that you establish and implement to comply with the requirements of the PCHF rule could only 

satisfy all requirements of 21 CFR 108.25(e) regarding recalls if it also includes procedures for 

notifying FDA of any recalls.

For help regarding the recall plan, see:

• Chapter 4 regarding preventive controls; and

• Chapter 14 regarding the recall plan.
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Table 16-6 Recall Plan

Requirements in Part 

117

(21 CFR)

Corresponding 

Requirements in 21 

CFR 108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR 

108.25 or Part 114 to Address 

Corresponding Requirements 

in the PCHF Rule

How You Can 

Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to 

Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part

114

• Requirements to 

identify and 

implement preventive 

controls:

o 117.135(a) 

(general 

requirement)

o 117.135(c)(5) 

(recall plan)

o 117.139 (recall 

plan)

• Requirement for 

written procedures for 

preventive controls:

o 117.126(b)(4)

o 117.135(b)

108.25(e): A commercial 

processor engaged in 

the processing of 

acidified foods shall 

prepare and maintain 

files on a current 

procedure for use for 

products under the 

processor's control, 

which that processor will 

ask the distributor to 

follow, including plans 

for recalling products 

that may be injurious to 

health; for identifying, 

collecting, warehousing, 

and controlling products; 

for determining the 

effectiveness of recalls; 

for notifying FDA of any 

recalls; and for 

implementing recall 

programs.

A written recall procedure that 

you establish and implement to 

comply with 21 CFR 108.25(e) 

could satisfy all requirements 

of the PCHF rule for a recall 

plan, as long as it includes 

procedures that describe the 

steps to be taken, and assign 

responsibility for taking those 

steps, to perform the following 

actions as appropriate to the 

facility:

• Directly notify the direct 

consignees of the food being 

recalled, including how to 

return or dispose of the 

affected food;

• Notify the public about any 

hazard presented by the 

food when appropriate to 

protect public health;

• Conduct effectiveness 

checks to verify that the 

recall is carried out; and

• Appropriately dispose of 

recalled food—e.g., through 

reprocessing, reworking, 

diverting to a use that does 

not present a safety concern, 

or destroying the food.

A written recall plan 

that you establish 

and implement to 

comply with 21 CFR 

117.139 could satisfy 

the requirements of 

21 CFR 108.25(e), 

as long as it includes 

procedures for 

notifying FDA about 

any recall.

16.11 Requirements for Preventive Control Management 

Components

With some exceptions, the preventive controls required by the PCHF rule are subject to the 

following preventive control management components as appropriate to ensure the 
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effectiveness of the preventive controls, taking into account the nature of the preventive control 

and its role in the facility's food safety system: 

• Monitoring in accordance with 21 CFR 117.145;

• Corrective actions and corrections in accordance with 21 CFR 117.150; and

• Verification in accordance with 21 CFR 117.155.

(See 21 CFR 117.140.) The exceptions to these requirements for preventive control 

management components are:

• The supply-chain program is subject to a subset of the preventive control management 

components (i.e., corrective actions and corrections in accordance with 21 CFR 117.150, 

review of records in accordance with 21 CFR 117.165(a)(4), and reanalysis in accordance 

with 21 CFR 117.170). (See 21 CFR 117.140(b).) 

• The recall plan is not subject to the requirements for preventive control management 

components. (See 21 CFR 117.140(c).)

Table 16-7 lists most9 of the specific provisions of the PCHF rule for establishing and 

implementing preventive control management components, including the requirements for 

written procedures for the preventive control management components. Table 16-7 also lists the 

corresponding requirements in part 114. Table 16-7 shows how you can leverage procedures, 

practices, and processes that you establish and implement to comply with 21 CFR 114.80(a)(2), 

114.80(a)(4), or 114.89, or that are listed in 21 CFR 114.90, to address the requirements of the 

PCHF rule for preventive control management components. To see how you can leverage 

records documenting compliance with recordkeeping requirements of part 114 to address the 

corresponding requirements for records documenting implementation of the preventive control 

management components, see Table 16-8.

Table 16-7 also shows how you can leverage the preventive control management components 

that you implement to satisfy the requirements of the PCHF rule to address the corresponding 

requirements in 21 CFR 114.80(a)(2), 114.80(a)(4), and 114.89. To see how you can leverage 

records documenting implementation of the preventive control management components to 

address corresponding recordkeeping requirements of part 114, see Table 16-8.

See also Appendix 16-1 in this chapter for key additional requirements specific to acidified 

foods. The emergency permit control regulations require that you provide FDA with any process 

and procedure information that we deem necessary to determine the adequacy of the process 

upon request. (See 21 CFR 108.25(c)(3)(ii).) The requirements of the PCHF rule applicable to 

validation of preventive controls correspond to the requirements of 21 CFR 108.25 and part 114 

for the adequacy of the scheduled process, and we ordinarily will review records applicable to 

9 See Table 16-8 for the records documenting implementation of the preventive control management 

components. 
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process validation during inspection. However, as required by 21 CFR 108.25(c)(3)(ii) you must 

send us any process and procedure information that we deem necessary to determine the 

adequacy of the process if we ask you to do so (e.g., as a follow-up to your submission of a 

scheduled process on Form FDA 2541e).

For help regarding preventive control management components, see:

• Chapter 5 regarding preventive control management components; and

• Chapter 6 regarding heat treatments as a process control.
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Table 16-7 Preventive Control Management Components 

Requirements in Part 117

(21 CFR)

Corresponding 

Requirements in 21 

CFR 108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with Requirements 

in 21 CFR 108.25 or Part 114 to 

Address Corresponding 

Requirements in the PCHF Rule

How You Can Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part 

114

• Requirements to establish 

and implement preventive 

control management 

components:

o 117.140 

o 117.145 (monitoring)

o 117.150 (corrective 

actions and corrections)

o 117.155 (verification)

o 117.160 (validation)

o 117.165 (verification of 

implementation and 

effectiveness)

o 117.165(a)(1) 

(calibration)

o 117.165(a)(2) (product 

testing)

o 117.165(a)(3) 

(environmental 

monitoring)

o 117.165(a)(4) (review of 

records)

• Requirement for written 

procedures for preventive 

control management 

components:

o 117.126(b)(5) and 

117.145(a) (monitoring)

o 117.126(b)(6) and 

117.150(a)(1) (corrective 

action procedures)

o 117.126(b)(7) and 

117.165(b) (verification)

o 117.165(b)(1) 

(calibration)

o 117.165(b)(2) (product 

testing)

o 117.165(b)(3) 

(environmental 

monitoring)

• 108.25(c)(3)(ii) 

Provide us with any 

process and 

procedure information 

that we deem 

necessary to 

determine the 

adequacy of the 

process

• 114.3(e): Scheduled 

process means the 

process selected by a 

processor as 

adequate for use 

under the conditions 

of manufacture for a 

food in achieving and 

maintaining a food 

that will not permit the 

growth of 

microorganisms 

having public health 

significance.

• 114.80(a)(2) Exercise 

of sufficient control, 

including frequent 

testing and recording 

of results, so that the 

finished equilibrium 

pH values for 

acidified foods are 

not higher than 4.6

• 114.80(a)(4) Testing 

and examination of 

containers shall occur 

often enough to 

ensure that the 

container suitably 

protects the food from 

leakage or 

contamination. 

• 114.89 (deviations 

from scheduled 

processes)

• 114.90 (methodology)

• Complying with 21 CFR 

114.80(a)(2) could satisfy the 

requirements of the PCHF rule 

for monitoring pH as a 

preventive control management 

component for pH control as a 

process control.

• Complying with 21 CFR 

114.80(a)(4) could satisfy the 

requirements of the PCHF rule 

for monitoring seam/seal 

integrity of finished product as a 

preventive control management 

component when applying a 

hermetic seal is a process 

control.

• Written procedures that you 

establish and implement to 

comply with the requirements of 

21 CFR 114.80(a)(2) and (a)(4) 

could satisfy the requirements of 

21 CFR 117.126(b)(5) and 

117.145(a) for written monitoring 

procedures. 

• Written procedures that you 

establish and implement to 

comply with the requirements of 

21 CFR 114.89 could satisfy the 

requirements of 21 CFR 

117.126(b)(6) and 117.150(a)(1) 

for written corrective action 

procedures as appropriate to the 

nature of the hazard and the 

nature of the preventive control.

• Written procedures that you 

establish and implement to 

comply with 21 CFR 114.90 

could satisfy some requirements 

of the PCHF rule for written 

procedures for preventive 

control management 

components (e.g., written 

procedures for monitoring or 

calibration of equipment). 

• Complying with the 

requirements of 21 

CFR 117.145 for 

monitoring preventive 

controls for (1) pH and 

(2) applying a 

hermetic seal could 

satisfy the 

requirements of 21 

CFR 114.80(a)(2) and 

(a)(4), respectively.

• Complying with the 

requirements of 21 

CFR 117.150 to 

establish and 

implement corrective 

action procedures 

could satisfy the 

requirements of 21 

CFR 114.89 for 

deviations from 

scheduled processes. 

• Complying with the 

requirements of 21 

CFR 117.155 and 

117.160 for process 

validation would be 

consistent with the 

definition of 

“scheduled process” 

in 21 CFR 114.3, but 

you still must submit 

information about the 

adequacy of the 

process to FDA upon 

request as required by 

21 CFR 

108.25(c)(3)(ii).
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Chapter 16 (Acidified Foods) - Page 25

16.12 Requirements for Records

Subpart A of part 117 requires that food establishments establish and maintain records that 

document required training. (See 21 CFR 117.9.) Subparts C and G of part 117 require that you 

have a written food safety plan (see 21 CFR 117.126), records documenting implementation of 

the food safety plan (see 21 CFR 117.190), and records documenting the supply-chain program 

(see 21 CFR 117.475(c)).

Subpart F of part 117 includes requirements applicable to all records required by part 117. For 

example:

• The owner, operator, or agent in charge of the facility must sign and date the food safety 

plan (21 CFR 117.310);

• Part 117 allows you to use existing records, supplemented as necessary to include all 

required information (§ 117.330(a)); and

• Part 117 does not require that records be kept in one set of records. If existing records 

contain some of the required information, any new information required by the PCHF rule 

may be kept either separately or combined with the existing records (§ 117.330(a)).

Table 16-8 shows how you can leverage compliance with the recordkeeping requirements of 21 

CFR 108.25(g) and 114.100(a) through (c) to address the recordkeeping requirements of the 

PCHF rule. Table 16-8 also shows how you can leverage compliance with the recordkeeping 

requirements of the PCHF rule to address the corresponding requirements in 21 CFR 

114.100(a), (b), and (c).10

See Appendix 16-1 in this chapter for key additional requirements specific to acidified foods. 

Importantly: 

• The regulations in 21 CFR 108.25 and part 114 each have a recordkeeping requirement that 

exceeds the corresponding recordkeeping requirement in part 117. Specifically, the 

regulations in 21 CFR 108.25 and part 114 require that you keep records required by part 

114 for 3 years, which exceeds the maximum 2-year record retention requirement in part 

117. (See 21 CFR 108.25(g), 114.100(e), and 117.315.)

• Part 114 requires records of distribution. (See 21 CFR 114.100(d).) Part 117 does not have 

a corresponding recordkeeping requirement. However, compliance with 21 CFR 114.100(d) 

could satisfy some requirements of 21 CFR 1.345 in part 1, subpart J (Establishment, 

Maintenance, and Availability of Records) for the identity of the immediate, subsequent 

recipients of food; likewise, compliance with the requirements of 21 CFR 1.345 in part 1, 

subpart J for the identity of the immediate, subsequent recipients of food could satisfy the 

requirements in 21 CFR 114.100(d) for records of distribution of acidified foods.

10 See also the discussions in sections 16.6 through 16.10 for limitations on whether complying with the 

requirements of 21 CFR 108.25 and part 114 can address the requirements of part 117 and vice versa. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 26

For help regarding the recordkeeping requirements of the PCHF rule for acidified foods, see 

section 6.16 in Chapter 6 regarding heat treatments as a process control, which provides an 

example of records documenting implementation of the food safety plan for a salsa.
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 27 

Table 16-8 Records 

Requirements in Part 117

(21 CFR)

Corresponding 

Requirements in 21 CFR 108 

or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR 

108.25 or Part 114 to Address 

Corresponding Requirements 

in the PCHF Rule

How You Can Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part 

114

• 117.9 (training)

• 117.126(c): Food safety 

plan

• 117.190(a): 

Implementation records, 

including records 

documenting:

o Basis for not 

establishing a 

preventive control 

(117.136(b)) 

o Monitoring 

(117.145(c))

o Corrective actions and 

corrections 

(117.150(d))

o Verification 

(117.155(b))

o Supply-chain program 

(117.475(c))

o Training of PCQI) 

(117.180(d))

• Subpart F:

o 117.301 (Applicability)

o 117.305 (General 

requirements) 

o 117.310 (Food safety 

plan)

o 117.315 (Record 

retention)

o 117.320 (Official 

review)

o 117.325 (Public 

disclosure)

o 117.330 (Use of 

existing records)

o 117.335 (Special 

requirements for 

written assurance)

• 114.100(a): Records of 

examinations of raw 

materials, packaging 

materials, and finished 

products, and of suppliers' 

guarantees or certifications

• 114.100(b): Processing and 

production records, 

including records of pH 

measurements and other 

critical factors intended to

ensure a safe product 

• 114.100(c): All departures 

from scheduled processes 

having a possible bearing 

on public health or the 

safety of the food

• 114.100(d): Records 

identifying initial distribution 

of the finished product to 

facilitate, when necessary, 

the segregation of specific 

food lots that may have 

become contaminated or 

otherwise unfit for their 

intended use

• 108.25(g) and 114.100(e): 

Records shall be retained at 

the processing plant or 

other reasonably accessible 

location for a period of 3 

years from the date of 

manufacture. 

• 108.25(f) and 114.10: All 

operators of processing and 

packaging systems shall be 

under the operating 

supervisions of a person 

who has attended a school 

approved by the 

Commissioner and who has 

been identified by that 

school as having 

satisfactorily completed the 

prescribed course of 

instruction.

• Records demonstrating 

compliance with 21 

114.100(a) could satisfy the 

requirements of 21 CFR 

117.475(c)(8) for sampling 

and testing records 

applicable to a supply-chain 

program, if your supply-chain 

program identifies any 

hazards requiring a supplychain applied control. 

• Records demonstrating 

compliance with 21 CFR 

114.100(b) could satisfy: 

o The requirements of 21 

CFR 117.145(c) for 

records of monitoring pH 

as a preventive control 

management component 

for pH control as a process 

control.

o The requirements of 21 

CFR 117.145(c) for 

records of monitoring when 

monitoring seam/seal 

integrity of finished product 

is a preventive control 

management component 

for the scheduled process.

• Records demonstrating 

compliance with 21 CFR 

114.100(c) could satisfy 

some requirements of 21 

CFR 117.150(d) for records 

of corrective actions and 

corrections.

• If your supply-chain 

program identifies any 

hazards requiring a 

supply-chain applied 

control, records that 

comply with 21 CFR 

117.475(c)(8) could 

satisfy corresponding 

requirements in 21 

CFR 114.100(a) for 

records of suppliers' 

guarantees or 

certifications. 

• Monitoring records 

that comply with 21 

CFR 117.145(c) could 

satisfy corresponding 

requirements in 21 

CFR 114.100(b) for 

records of pH 

measurements and 

other critical factors. 

• Corrective action

records that comply 

with 21 CFR 

117.150(d) could 

satisfy corresponding 

requirements in 21 

CFR 114.100(c) for 

records of all 

departures from 

scheduled processes 

having a possible 

bearing on public 

health or the safety of 

the food. 
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Chapter 16 (Acidified Foods) - Page 28 

16.13 Requirements for Coding

Part 114 requires that each container or product be marked with an identifying code 

permanently visible to the naked eye. (See 21 CFR 114.80(b) for the complete requirements.) 

There is no corresponding requirement for coding in the PCHF rule. You must comply with all 

requirements for coding in 21 CFR 114.80(b) even though there is no corresponding 

requirement for coding in the PCHF rule.

16.14 References

Al Dujaili J and RE Anderson, 1991. Aciduric, pH-Elevating Bacillus which cause 

noneffervescent spoilage of underprocessed tomatoes. Journal of Food Science 56 (6): 1611-

1613.

FDA, 2009. Guidance for Industry: Questions and Answers Regarding the Reportable Food 

Registry as Established by the Food and Drug Administration Amendments Act of 2007 

(https://www.fda.gov/FoodGuidances).

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 

(Edition 2) (https://www.fda.gov/FoodGuidances). 

FDA, 2012. Guidance for Industry: Questions and Answers Regarding Establishment and 

Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, 

Receive, Hold, or Import Food (Edition 5) (https://www.fda.gov/FoodGuidances).

FDA, 2016. Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment 

Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process 

Filing Forms) to FDA in Electronic or Paper Format (https://www.fda.gov/FoodGuidances) 

FDA, 2018. Questions and Answers Regarding Food Facility Registration (Seventh Edition) 

(https://www.fda.gov/FoodGuidances). 

FDA, 2020. Guidance for Industry: Product Recalls, Including Removals and Corrections 

(https://www.fda.gov/safety/industry-guidance-recalls/guidance-industry-product-recallsincluding-removals-and-corrections).

Fields M, A Zamora, and M Bradsher. 1977. Microbiological analysis of home canned tomatoes 

and green beans. Journal of Food Science 42: 931-934.

Institute of Food Technologists. 2001. Evaluation and Definition of Potentially Hazardous Foods. 

Chapter 3. IFT/FDA Contract No. 223-98-2333 (https://www.fda.gov/media/103613/download). 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 29 

Larousse J and B Brown. 1997. Thermobacteriology. In Food Canning Technology, eds J 

Larousse and B Brown, pp.117-150. New York: Wiley-VCH

Montville T. 1982. Metabiotic effect of Bacillus licheniformis on Clostridium botulinum: 

Implications for home canned tomatoes. Applied and Environmental Microbiology 44 (2): 334-

338.

Odlaug TE, and IJ Pflug. 1978. Clostridium botulinum and acid foods. Journal of Food 

Protection 41 (7): 566-573.

Rodriguez J, M Cousin, and P Nelson. 1992. Evaluation of anaerobic growth of Bacillus 

licheniformis and Bacillus subtilis in tomato juice. Journal of Food Protection 9: 672-677.

Appendix 16-1 Key Specific Acidified Food Requirements 

The requirements of 21 CFR 108.25 and part 114 include some requirements that either have 

no explicitly corresponding requirement in part 117 or exceed the corresponding requirement in 

part 117. Appendix Table 16-1-1 lists the key additional requirements specific to acidified foods 

and, when applicable, resources that are available to help you comply with those additional 

requirements. 

Appendix Table 16-1-1 Key Specific Acidified Food Requirements 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Submit food canning 

establishment registration to 

FDA using Form FDA 2541

21 CFR 108.25(c)(1) Registering your 

establishment as a food 

canning establishment 

using Form FDA 2541 (as 

required by 21 CFR 

108.25(c)(1)) is in addition 

to registering your food 

facility using Form FDA 

3537 (as required by 21 

CFR Part 1, Subpart H)

• FDA, 2016

• FDA, 2018 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 30 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Submit scheduled process to 

FDA using Form FDA 2541e

21 CFR 108.25(c)(2) See the discussion in

section 16.10.1. Although 

you can leverage Form FDA 

2541e to address the 

requirements of the PCHF 

rule for written process 

controls for biological 

hazards requiring a 

preventive control, including 

Form FDA 2541e in the 

food safety plan that you 

keep onsite does not affect 

your responsibility to submit 

Form FDA 2541e to FDA.

FDA, 2016

Provide FDA with information 

about the scheduled process 

and procedure upon FDA’s 

request

21 CFR 108.25(c)(3)(ii) See the discussion in 

section 16.11. The 

requirements of the PCHF 

rule applicable to validation 

of preventive controls 

correspond to the 

requirements of 21 CFR 

108.25 and part 114 for the 

adequacy of the scheduled 

process, and we ordinarily 

will review records 

applicable to process 

validation during inspection. 

However, as required by 21 

CFR 108.25(c)(3)(ii), you 

must send us any process 

and procedure information 

that we deem necessary to 

determine the adequacy of 

the process if we ask you to 

do so (e.g., as a follow-up 

to your submission of a 

scheduled process on Form 

FDA 2541e).

N/A
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 31 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Notify FDA about problems 

when food is in commerce

21 CFR 108.25(d) 

(problems include 

spoilage, process 

deviation, or 

contamination with 

microorganisms, the 

nature of which has 

potential healthendangering significance)

Notifying FDA about 

problems when an acidified 

food is in commerce is in 

addition to your 

responsibility to report 

problems to the Reportable 

Food Registry (when there 

is a reasonable probability 

that the use of, or exposure 

to, an article of food will 

cause serious adverse 

health consequences or 

death to humans or 

animals) 

• FDA, 2009

• FDA, 2010

Recall procedure that incudes 

plans for notifying FDA of any 

recalls

21 CFR 108.25(e) See the discussion in 

section 16.10.4. Although a 

plan for notifying FDA of 

any recalls is not required 

by the PCHF rule, including 

a plan for notifying FDA of 

any recalls in the written 

recall plan that you 

establish in accordance with 

21 CFR 117.139 could also 

satisfy the requirements of 

21 CFR 108.25(e) for a 

recall procedure.

FDA, 2003

Satisfactory completion of the 

prescribed course of 

instruction in a school 

approved by the 

Commissioner for giving 

instruction in food-handling 

techniques, food-protection 

principles, personal hygiene 

and plant sanitation practices, 

pH controls and critical factors 

in acidification

• 21 CFR 108.25(f)

• 21 CFR 114.10

See the discussions in 

sections 16.6 and 16.7. 

Satisfactorily completing the 

prescribed course of 

instruction in a school 

specified in 21 CFR 

108.25(f) and 114.10 may 

not provide an individual 

with all qualifications 

applicable to supervisory 

personnel as required by 21 

CFR 117.4 or all 

qualifications applicable to a 

PCQI as required by 21 

CFR 117.180(c)(1).

N/A
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 32 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

The scheduled process for an 

acidified food must control 

microorganisms of non-health 

significance in addition to 

pathogens.

21 CFR 114.80(a) See the discussion in 

sections 16.9 and 16.10.1, 

and 16.11. Microorganisms 

of non-health significance, 

by themselves, are not 

“hazards” as that term is 

defined in part 117. 

However, when critical 

factors are not carefully 

controlled, the vegetative 

cells of some 

microorganisms of nonhealth significance (such as 

some spoilage bacteria) can 

grow in an acid environment 

and, in so doing, cause the 

pH of the food to increase. 

Therefore:

• A knowledgeable person 

could identify 

microorganisms of nonhealth significance in 

shelf-stable acidified 

foods as biological 

hazards requiring a 

preventive control. 

• The preventive control 

could be the scheduled 

process that you submit 

to us on Form FDA 

2541e. 

• The preventive control 

management components 

could be monitoring pH 

and validation that 

establishes the adequacy 

of the process. 

N/A

Records of distribution 21 CFR 114.100(d) Compliance with 21 CFR 

114.100(d) could satisfy 

some requirements of 21 

CFR 1.345 in part 1, 

subpart J (Establishment, 

Maintenance, and 

Availability of Records) for 

the identity of the 

immediate, subsequent 

recipients of food

FDA, 2012
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 33 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Record retention for 3 years • 21 CFR 108.25(g)

• 21 CFR 114.100(e)

See the discussion in 

section 16.12. The 

regulations in 21 CFR 

108.25 and part 114 each 

have a recordkeeping 

requirement that exceeds 

the corresponding 

recordkeeping requirement 

in part 117. 

N/A

Coding 21 CFR 114.80(b) See the discussion in 

section 16.13. Part 114 

requires that each container 

or product be marked with 

an identifying code 

permanently visible to the 

naked eye; there is no 

corresponding requirement 

for coding in the PCHF rule.

N/A