1
Food Safety and Inspection Service:

HACCP Systems Validation 

Training

2
• Purpose/Implementation Plan

• History of Initial Validation Requirements/Need for an Industry 

Compliance Guideline

• Element 1: Scientific Support (Design)

• Element 2: Initial In-plant Validation Data (Execution)

• Timeframe for an establishment to complete initial validation

• Initial Validation vs. Ongoing Verification

• Next Steps/Key Points

Food Safety and Inspection Service:

Presentation Outline

3
• Although the HACCP regulations were implemented over 

15 years ago, FSIS has found through Food Safety 

Assessments (FSAs) that establishments have not 

complied with the initial validation requirement. 

• In particular, establishments have not collected the 

necessary initial in-plant validation data demonstrating 

that the HACCP system is functioning as intended. 

• Therefore, FSIS determined that additional initial 

validation guidance is needed.

4

Food Safety and Inspection Service:

Background
• In March 2010, FSIS 

posted on its Web site an 

initial draft of the HACCP 

Systems Validation 

Compliance Guideline. 

Since then, FSIS has 

revised the guidance 

document several times 

in response to public 

comment. The final 

version has now been 

published.

4b

Food Safety and Inspection Service:

Background
• The purpose of this training is to inform IPP and supervisory personnel 

of the general concepts of initial validation and the Agency’s position 

on commonly asked questions related to the initial validation 

requirements.

• This presentation will give a general overview because FSIS will not 

begin verifying whether large establishments meet all validation 

requirements, including maintaining in-plant validation data, until 

January 4, 2016, and will not begin verifying whether small and very 

small meet all validation requirements until April 4, 2016. 

• FSIS is delaying the implementation because the Agency recognizes 

that some establishments may not have retained their original initial 

in-plant validation from when their HACCP systems were first 

implemented. These establishments are being given time to gather 

any necessary initial in-plant validation data.

5

Food Safety and Inspection Service:

Purpose of the Training
• Since the implementation will be 

delayed, FSIS field personnel are not to 

conduct any new verification or 

enforcement activities concerning 

validation at this time. 

• IPP are to continue to follow the 

instruction in FSIS Directive 5000.6, 

Performance of the Hazard Analysis 

Verification (HAV) Task and are not to 

cite the lack of in-plant validation data as 

the only reason for the documentation of 

noncompliance. 

• FSIS will provide further instructions and 

training regarding enforcement activities 

related to validation data in subsequent 

issuances. 

6

Food Safety and Inspection Service:

Implementation
• Initial validation consists of two 

elements:

• Requirements related to scientific 

support and initial in-plant validation 

data are being verified during the HAV 

task and during FSAs. 

• However, FSIS personnel are not currently 

documenting lack of initial in-plant 

validation as the sole reason for 

noncompliance. 

• The initial in-plant validation data is the 

new focus discussed in this training and 

lack of data will eventually be enforced 

by FSIS personnel once further 

instructions are provided. 

7

Food Safety and Inspection Service:

What is New in this Training?

Element 1: 

Scientific or 

Technical 

Support

(Design)

Element 2: Initial 

in-plant Validation 

Data 

(Execution)
• Under the Federal Meat Inspection Act (FMIA) 

and the Poultry Products Inspection Act (PPIA), 

meat and poultry establishments inspected by 

FSIS are required to maintain sanitary conditions 

sufficient to prevent contamination of products 

with filth and to prevent meat and poultry 

products from being rendered injurious to 

health (21 U.S.C. 601(m) and 608 (FMIA); 21 

U.S.C. 453 (g) and 456 (PPIA)).

8

Food Safety and Inspection Service:

What is FSIS’ Statutory Authority (FMIA/PPIA) to Require Initial 

Validation?
• HACCP and sanitation regulations are sanitary 

measures. To ensure products are handled and 

held in a sanitary manner, establishments must 

follow the HACCP and sanitation regulations.

• To enforce the HACCP rule, IPP must show why 

the establishment is not complying with the 

statutory provisions that support the regulation.

9

Food Safety and Inspection Service:

What is FSIS’ Statutory Authority (FMIA/PPIA) to Require Initial 

Validation?
• Section 608 of the FMIA and 456 of the PPIA give the Agency authority 

for enforcing HACCP. 

• So, if the Agency is to enforce the HACCP and sanitation rules (SPS and 

Sanitation SOP), we will need to show how an establishment’s failure 

to follow the sanitary measures required by HACCP or sanitation rules 

creates insanitary conditions in its operation that resulted in the 

production of product that may be injurious to health.

• For example, failure by an establishment to provide scientific support 

for their HACCP system could create insanitary conditions because, 

without such supporting documentation, the establishment may not 

have adequately addressed conditions that could cause the product to 

be injurious to health. 

10

Food Safety and Inspection Service:

How Can IPP Show an Establishment is Not Complying with the Statutory 

Provisions?
• “Initial Validation. Upon completion of 

the hazard analysis and development of 

the HACCP plan, the establishment shall 

conduct activities designed to determine 

that the HACCP plan is functioning as 

intended. During this HACCP plan 

validation period, the establishment shall 

repeatedly test the adequacy of the 

CCP’s, critical limits, monitoring and 

recordkeeping procedures, and 

corrective actions set forth in the HACCP 

plan. Validation also encompasses 

reviews of the records themselves, 

routinely generated by the HACCP 

system, in the context of other validation 

activities.”

9 CFR 417.4(a)

• “Every establishment shall 

validate the HACCP plan’s 

adequacy in controlling the food 

safety hazards identified during 

the hazard analysis, and shall 

verify that the plan is being 

effectively implemented.”

9 CFR 417.4(a)(1)

11

Food Safety and Inspection Service:

What is Required?

(Emphasis added)
• IPP verification activities show that many establishments 

have not properly validated their HACCP system.

• Inadequate initial validation has been linked to food safety 

problems: 

– Chicken pot pie Salmonella illness outbreak in 2007 and 2011 

Turkey Burger Salmonella Illness outbreak;

– 2011 Lebanon bologna E. coli O157:H7 illness outbreak; and 

– Veal E. coli O157:H7 and adulterant non-O157 STEC positives 

from FSIS testing in 2012. 

• Therefore, FSIS determined that additional initial validation 

guidance for HACCP systems is needed.

Food Safety and Inspection Service:

HACCP Systems Initial Validation

12
• In October 2007, frozen pot pies were linked 

to an outbreak of salmonellosis. 

• The investigation revealed likely cause of 

illnesses was consumers not cooking the 

products in the microwave adequately.

• The primary conclusion of the investigation 

was that the cooking instructions on not 

ready-to-eat products must be validated when 

consumer cooking is used to support decisions 

in the hazard analysis.

13

Food Safety and Inspection Service:

Need for Guidance – Chicken Pot Pie Outbreak

Company A

FSIS Recall Release

RC-044-2007
• Initial validation is the process of demonstrating that the HACCP 

system as designed can adequately control potential hazards. 

• Under 9 CFR 417.4(a)(1) establishments are required to assemble 

two types of supporting documentation to demonstrate the HACCP 

system has been validated:

– Scientific or technical support (design) and

– Initial in-plant validation data (execution) 

• Initial validation encompasses activities designed to determine 

whether the entire HACCP system is functioning as intended. 

Food Safety and Inspection Service:

What is HACCP Systems Initial Validation?

14
• The HACCP system is defined as the HACCP 

plan in operation, including the HACCP plan 

itself. 

• The HACCP plan in operation includes the 

hazard analysis, any supporting 

documentation including prerequisite 

programs supporting decisions in the hazard 

analysis, and all HACCP records. 

Food Safety and Inspection Service:

What is the HACCP System?

15
• The answer depends on whether the prerequisite 

program is considered part of the HACCP system.

• Prerequisite programs designed to support a decision 

in the hazard analysis are part of the HACCP system. 

• When an establishment determines that a potential 

hazard is not reasonably likely to occur because the 

implementation of a prerequisite program prevents 

conditions that make the potential hazard likely, that 

prerequisite program then becomes part of the HACCP 

system and must be validated. 

Food Safety and Inspection Service:

Do Prerequisite Programs Have to be Validated?

16
Prerequisite programs that may be 

used to support decisions in the 

hazard analysis and, if used as 

support, must be validated include:

• Sanitation SOPs

• Purchase specifications

• Antimicrobial interventions

• Sanitary dressing programs

• Allergen control programs

Prerequisite programs that are 

unlikely to be used to support 

decisions in the hazard analysis, and 

therefore, do not have to be 

validated include:

• Maintenance programs

• Facilities and grounds 

programs

• Pest control programs

• Written recall plans

• Traceability programs

17

Food Safety and Inspection Service:

Prerequisite Program Types
Food Safety and Inspection Service:

Prerequisite Program Example

18a

Fresh Pork Hazard Analysis

Step Potential Hazard RLTO? Basis/

Justification

Raw meat 

storage

Biological:

Pathogen growth

No Adherence to a 

temperature control 

program (storage 

temperature ≤45°F and 

time product is in 

storage ≤5 days) 

prevents pathogen 

growth (Tompkin 

paper).

Since adherence to the temperature and time parameters 

in the program is used as justification that pathogen 

growth is not reasonably likely to occur the temperature 

control program must be validated.
Food Safety and Inspection Service:

Prerequisite Program Example

18b
19

Food Safety and Inspection Service:

Two Elements of Initial Validation

Element 1: 

Scientific or 

Technical 

Support

(Design)

•The theoretical principles, expert advice from processing 

authorities, scientific or technical data, peer-reviewed journal 

articles, pathogen modeling programs, or other information 

demonstrating that particular process control measures can 

adequately prevent, reduce, or eliminate specific hazards.

Element 2: Initial 

in-plant Validation 

Data 

(Execution)

• The in-plant observations, measurements, microbiological test 

results, or other information demonstrating the control measures 

in the HACCP system can perform as expected within a 

particular establishment to achieve the intended food safety 

objective.
Food Safety and Inspection Service:

Two Elements of Initial Validation

19b

Element 1: 

Scientific or 

Technical 

Support

(Design)

• Gather scientific support (e.g., published processing guidelines, journal articles, challenge 

studies, etc.) that:

• Closely matches the actual process, and

• Shows that the establishment’s process prevents, reduces, or eliminates the hazard identified in 

the hazard analysis; and 

• Identify the critical operational parameters from the scientific support relevant to the 

establishment's process.

Element 2: Initial 

in-plant Validation 

Data 

(Execution)

• Implements critical operational parameters in the actual production process consistent with the 

parameters in the scientific or technical support; 

• Identifies at least one product from each HACCP category to gather in-plant validation data; 

• Collects in-plant data demonstrating the effectiveness of the implementation of the critical operational 

parameters for at least one product from each HACCP category; and

• Analyzes the data to determine whether the critical operational parameters are being implemented 

effectively.
• Critical operational 

parameters are the 

specific conditions that 

the intervention must 

operate under in order 

for it to be effective. 

• Examples of critical 

operational parameters 

include:

• Time

• Temperature

• Concentration

• Humidity

• Dwell Time

• pH

• Contact Time

• Product Coverage

• Pressure 

• Point of application

20

Food Safety and Inspection Service:

Critical Operational Parameters
• FSIS encourages establishments to collect microbiological 

data as part of initial in-plant validation data but does not 

require that they do so to comply with the initial validation 

requirements provided the establishment: 

– Has adequate scientific supporting documentation (the first 

element of initial validation), 

– Is following the same parameters in the scientific support, and 

– Can demonstrate that it can meet the critical parameters during 

operation (the second element of initial validation).

Food Safety and Inspection Service:

Is In-plant Microbiological Data Required?

21
• To meet the first element of initial validation, 

establishments should:

– Gather scientific or technical support (e.g., published processing 

guidelines, journal articles, challenge studies, etc.) for its HACCP 

system that:

• Closely matches the actual process; and 

• Shows that the establishment’s process will prevent, reduce, or 

eliminate the hazard identified in the hazard analysis; and 

– Identify the critical operational parameters from the scientific support 

relevant to the establishment's process.

Food Safety and Inspection Service:

How Does the Establishment Meet Element 1: Scientific Support?

22
• Published Processing 

Guidelines including 

FSIS Guidelines

Food Safety and Inspection Service:

What are the Types of Scientific or Technical Support an Establishment 

May Use?

23a
• Best Practice Guidelines

Food Safety and Inspection Service:

What are the Types of Scientific or Technical Support an Establishment 

May Use?

23b
• Peer-reviewed Scientific 

Data/Information

Food Safety and Inspection Service:

What are the Types of Scientific or Technical Support an Establishment 

May Use?

23c
• Challenge or Inoculated 

Pack Study

Food Safety and Inspection Service:

What are the Types of Scientific or Technical Support an Establishment 

May Use?

23d
• Pathogen Modeling 

Program

Food Safety and Inspection Service:

What are the Types of Scientific or Technical Support an Establishment 

May Use?

23e
• Regulatory Performance 

Standards

Food Safety and Inspection Service:

What are the Types of Scientific or Technical Support an Establishment 

May Use?

23f
• In all cases, the scientific support should identify: 

• The hazard (biological, physical, and chemical),

• The expected level of hazard reduction or prevention to be 

achieved, 

• All critical operational parameters or conditions necessary, 

• The processing steps that will achieve the specified 

reduction or prevention, and 

• How these processing steps can be monitored. 

• The establishment should evaluate the scientific 

support to determine whether it sufficiently 

relates to the process, product, and hazard 

identified in the hazard analysis. 

Food Safety and Inspection Service:

What is Considered Adequate Scientific or Technical Support?

24
Food Safety and Inspection Service:

Why is it Important the Scientific Support Matches the Actual Process?

• In March 2011, there was a recall of a Lebanon 

bologna product that was associated with a 

foodborne illness outbreak of E. coli O157:H7. 

• An FSIS investigation revealed that the 

establishment had not properly validated their 

process. 

• In particular, there were difference in the 

diameter and type of casing material between 

the product studied and the actual product that 

likely led to a lower reduction in foodborne 

pathogens of concern than what was 

demonstrated in the scientific support. 

25

Diameter of product produced –

52 to 119 mm

Diameter of product studied –

27 mm

Impermeable

glass “casing” of 

product studied

Semi-permeable

casing of actual

product produced
• Scientific support for a product other than 

meat and poultry without additional scientific 

or technical support. 

• Documentation in the form of a No Objection 

Letter or FSIS Directive 7120.1 without 

additional scientific or technical support.

• Expert opinion from a processing authority 

stating the safety of a product without any 

reference to established scientific principles 

or peer-reviewed data.

Food Safety and Inspection Service:

What are Some Examples of Inadequate Scientific or Technical Support?

26
Food Safety and Inspection Service:

Examples

27a

Hazard

Critical Operational 

Parameters

Level of prevention
Food Safety and Inspection Service:

Examples

27b

Hazard

Log 

reduction

Critical Operational Parameters (time, temperature, product type)

Process

step
Food Safety and Inspection Service:

Examples

28

Log 

reduction

Antimicrobial type and concentration. Other critical operational parameters not shown (distance of spray to carcass 

surface, carcass coverage, application method and pressure, contact time, temperature.) 

Table 3. Antimicrobial effectiveness of several food-safe compounds used to 

eliminate meatborne pathogens from experimentally inoculated beef surfaces.

Hazard
• In general, the biological hazards studied in the 

scientific support should be the same as those 

identified in the hazard analysis.

• Ensuring that the scientific support contains 

microbiological data for the hazard listed in the 

hazard analysis is particularly important for 

slaughter processes where interventions have 

different efficacy depending on the species of 

product and the pathogen.

29

Food Safety and Inspection Service:

Do the Biological Hazards in the Scientific Support Have to Match Those 

Identified in the Hazard Analysis?
• Although Appendix A was developed based on 

experiments measuring the efficacy of thermal 

processes on Salmonella. Salmonella can be 

used as an indicator of lethality for other 

pathogens such as E. coli O157:H7 and Listeria 

monocytogenes. 

• At this time, interventions validated to control 

E. coli O157:H7 should be effective in 

controlling non-O157 STEC.

• Data from indicator or surrogate organisms 

may be used if there is sufficient data to 

establish a relationship between the presence 

or level of a pathogen or toxin and the 

indicator organism. 

30

Food Safety and Inspection Service:

When Can the Biological Hazards in the Scientific Support Not Match 

What’s in the Hazard Analysis?
• To meet the second element of initial validation, establishments should:

– Implements critical operational parameters in the actual production 

process consistent with the parameters in the scientific or technical 

support; 

– Identifies at least one product from each HACCP category to gather inplant validation data; 

– Collects in-plant data demonstrating the effectiveness of the 

implementation of the critical operational parameters for at least one 

product from each HACCP category; and

– Analyzes the data to determine whether the critical operational 

parameters are being implemented effectively.

Food Safety and Inspection Service:

How Does the Establishment Meet Element 2: In-plant Validation Data?

31
• To be effective, the process procedures should be 

consistent with the critical operational parameters in 

the supporting documentation. 

• If all of the critical operational parameters from the 

support are not implemented, then an establishment 

can not expect to have the same efficacy in-plant.

32a

Food Safety and Inspection Service:

Implementing Critical Operational Parameters
• This image shows 

incomplete coverage. 

In particular, only part 

of the carcass is 

receiving the spray. If 

complete coverage 

can’t be achieved then 

the intervention will not 

be as effective.

32b

Food Safety and Inspection Service:

Implementing Critical Operational Parameters
• This image also shows 

incomplete coverage. In 

particular, no spray is 

applied to the underside of 

products. In addition, not all 

pieces on the conveyor belt 

are being treated because 

the arc of the spray is too 

narrow to cover all product 

that could pass on the 

conveyor. The spray is also 

not being applied to all 

pieces due to product piling 

up and overlapping on the 

conveyor belt.

32c

Food Safety and Inspection Service:

Implementing Critical Operational Parameters
• The establishment should implement: 

– the same parameters or 

– If is uses different parameters it should support why those 

different parameters would be equally as effective. 

• For example, the Tompkin paper can be used to 

support a storage temperature CCP for raw meat of 

45oF even though it cites 44.6oF as minimum 

growth temperature for Salmonella. This rounding 

is suitable because the growth rate of Salmonella 

at 45oF is not significantly different from its growth 

rate at 44.6oF.

Food Safety and Inspection Service:

How Closely do the Parameters Implemented in the Actual Process Need 

to Match the Scientific Support?

33a
Food Safety and Inspection Service:

How Closely do the Parameters Implemented in the Actual Process Need 

to Match the Scientific Support?

33b
• If an establishment is using the scientific support as support for the 

development of a CCP and its critical limits (9 CFR 417.5(a)(2)) to prevent, 

reduce, or eliminate a hazard identified as RLTO, then it is recommended

that the establishment incorporate all of the critical operational 

parameters into the critical limits of the CCP. 

• An establishment may determine through decision-making that some of 

the critical operational parameters will be measured on an ongoing basis 

as part of a prerequisite program. 

• An establishment may also determine that it only needs to check that 

some critical operational parameters are implemented consistent with the 

support during the initial validation period (e.g., spatial configuration, 

equipment type to the extent that it affects other parameters, or 

ingredient formulation provided it does not change). 

Food Safety and Inspection Service:

Do All Critical Operational Parameters Need to Become Part of a CCP?

34
• The HACCP Systems Validation Compliance 

Guideline, recommends that establishments 

collect initial in-plant validation data for at least 

one product from each HACCP process category 

utilized.

• Establishments should collect initial in-plant 

validation data for all CCPs and prerequisite 

programs used to support decisions in the hazard 

analysis related to that product to demonstrate 

they are being implemented as designed. 

Food Safety and Inspection Service:

How Many Products do Establishments Have to Collect In-plant 

Validation Data for?

35
• The Compliance Guideline contains food science 

principles establishments can use to select the 

product within each HACCP process category that 

represents the worst-case.

Food Safety and Inspection Service:

How Can an Establishment Determine which Product to Select for Initial 

In-plant Validation Data Collection?

36

• Size and shape of the food: The size and shape of food affects heat 

penetration, heating rate, and heating uniformity. Irregularly shaped 

products, for example, are subjected to non-uniform heating because of 

differences in product thickness. In addition, in thicker products, more time 

will be needed for the heat to penetrate to the center of the product. 

– How this criterion could be used: If an establishment produces several fully 

cooked deli meat products of various thicknesses, the establishment should 

gather data on the thickest product because heat penetration is critical. 
• In cases where the establishment’s process is: 

– Implemented consistent with the process specifications 

described in the scientific support, and 

– When the scientific support used contains microbiological 

data specifying the level of pathogen reduction achieved 

by the intervention strategy for the target pathogen 

identified in the hazard analysis, the establishment should:

• Demonstrate the critical operating parameters are being met by 

gathering in-plant data (e.g., data on quantifiable characteristics of 

the critical operational parameters such as pressure, temperature, 

and concentration).

Food Safety and Inspection Service:

When Does an Establishment Only Need Initial In-plant Validation Data 

for the Critical Operational Parameters?

37
• If an establishment is using the Tompkin paper to support 

a storage temperature CCP for raw meat of ≤45°F and 

time product is in storage ≤5 days than it should gather 

in-plant validation data demonstrating:

– Ambient air storage temperature does not exceed 

45°F and that product is not held in storage for more 

than 5 days and

– Data demonstrating the product temperature 

correlates to the ambient storage temperature. 

Food Safety and Inspection Service:

Example of When an Establishment Only Needs Initial In-plant Validation 

Data for the Critical Operational Parameters

38
• In cases where the establishment’s process is:

– Not implemented in a manner that is consistent with the process 

specifications described in the supporting documentation, or 

– When the scientific support used does not contain microbiological 

data specifying the level of pathogen reduction achieved by the 

intervention strategy for the target pathogen identified in the hazard 

analysis, the establishment should:

• Demonstrate the modified critical operating parameters are being met (e.g., 

data on quantifiable characteristics of the critical operational parameters such 

as pressure, temperature, and concentration), AND

• Demonstrate the intervention’s effectiveness under actual in-plant conditions 

(e.g., through microbiological data).

Food Safety and Inspection Service:

When Should Establishments Also Gather In-plant Microbiological Data?

39
• If a poultry establishment is implementing an 

intervention that has been validated to reduce 

Salmonella for purposes of reducing 

Campylobacter and it can’t find literature 

documenting the intervention’s effectiveness 

against Campylobacter, the establishment 

should gather in-plant microbiological data 

along with data on the critical operational 

parameters. 

Food Safety and Inspection Service:

Example of When In-plant Microbiological Data Should be Gathered

40
• Establishments are being given time (until January 4, 2016 or April 4, 2016 depending on size) to 

assemble the initial in-plant validation data if they did not kept it originally.

• This data will generally include 90 days of production records and any additional documents 

gathered to demonstrate the establishment is able to effectively execute the critical operating 

parameters in their HACCP system including:

– HACCP records generated during 90 days when the current HACCP system is in operation.

– Decision-making documents for the CCPs and critical operational parameters data gathering 

methods.

– Records associated with initial equipment set up or calibration that contain data for any 

critical operational parameters that did not become CCPs to support that the parameters 

were met during the initial validation period.

– Any establishment sampling results for the product and process of interest.

Food Safety and Inspection Service:

What if an Establishment No Longer has its In-plant Data?

41
• New establishments are issued a conditional grant of 

inspection for a period up to 90 days in accordance 

with 9 CFR 304.3(b) and 381.22(b) during which they 

must complete initial validation as required in 9 CFR 

417.4(a)(1).

• Additionally, 9 CFR 304.3(c) and 381.22(c) require 

establishments producing a new product to complete 

the initial validation of the new HACCP plan as 

required in 9 CFR 417.4(a)(1) during a period not to 

exceed 90 days after the date the new product is 

produced for distribution in commerce

Food Safety and Inspection Service:

What is the Timeframe for an Establishment to Complete Initial 

Validation?

42
• Consistent with these requirements, in-plant 

validation data should encompass the first 90 

calendar days of an establishment’s 

processing experience with a modified HACCP 

plan based on a reassessment as per 9 CFR 

417.4(a)(3).

Food Safety and Inspection Service:

What is the Timeframe for an Establishment to Complete Initial 

Validation?

43
• In all cases,

– For large establishments, 90 calendar days equates to approximately 

60 production days. 

– A minimum of 13 production day records within those initial 90 

calendar days should be used for the initial validation of a small or 

very small establishment’s HACCP system. 

– A small or very small establishment may make a request to FSIS in 

writing for additional time. 

• During this time, the establishment should gather its initial in-plant 

validation data at an increased frequency compared to the 

frequency listed in the HACCP plan or prerequisite program. 

Food Safety and Inspection Service:

What do 90 Calendar Days Equate to in Production Days?

44
Food Safety and Inspection Service:

Example: Storage Temperature Control Program

45a

Product Hazard Process

Critical 

Operational 

Parameters

Initial Validation

Scientific or Technical Support In-Plant Validation Data

Post-lethality 

exposed 

ready-to-eat 

meats

Biological -Listeria 

monocytogenes

Packaging -Time 

and Temperature 

GMP’s 

Packaging 

room 

temperature ≤ 

50°F.

Product 

remains in 

packaging < 5

hours prior to 

refrigerated

storage.

Tompkin Paper. Table 2. 

http://www.meathaccp.wisc.edu

/Model_Haccp_Plans/assets/ra

w_ground/TompkinPaper.pdf.

In plant records for 90 

day period 

demonstrating 

ambient air 

temperature in the 

assembly room does 

not exceed 50°F and 

that product is not held 

during packaging for 

more than 5 hours. In 

plant records for 90 

day period 

demonstrating a 

correlation between 

product temperature 

and ambient 

temperature.
Food Safety and Inspection Service:

Example: Storage Temperature Control Program

45b
Food Safety and Inspection Service:

Example: Storage Temperature Control Program

45c

Product Hazard Process

Critical 

Operational 

Parameters

Initial Validation

Scientific or Technical Support In-Plant Validation Data

Post-lethality 

exposed 

ready-to-eat 

meats

Biological -Listeria 

monocytogenes

Packaging -Time 

and Temperature 

GMP’s 

Packaging 

room 

temperature ≤ 

50°F.

Product 

remains in 

packaging < 5

hours prior to 

refrigerated

storage.

Tompkin Paper. Table 2. 

http://www.meathaccp.wisc.edu

/Model_Haccp_Plans/assets/ra

w_ground/TompkinPaper.pdf.

In plant records for 90 

day period 

demonstrating 

ambient air 

temperature in the 

assembly room does 

not exceed 50°F and 

that product is not held 

during packaging for 

more than 5 hours. In 

plant records for 90 

day period 

demonstrating a 

correlation between 

product temperature 

and ambient 

temperature.
Food Safety and Inspection Service:

Example: Antimicrobial Intervention

46a

Product Hazard Process Critical Operational Parameters

Initial Validation

Scientific Support Initial In-Plant Data

Beef Carcass Biological –

E. coli

O157:H7, 

Salmonella 

Typhimurium

Chemical -

excessive 

levels of 

lactic acid

Physical -

none

Lactic Acid 

Spray

2% lactic acid applied within 

12 inches of carcass surface 

and entire carcass covered 

using a stainless steel spray 

tank fitted with a pressure 

gauge and air compressor.

Each side of beef should be 

sprayed for at least 1 minute 

and sprayed from top to 

bottom and sufficient lactic 

acid is applied such that 

some of it drips off. 

Note: The entire carcass is 

sprayed with lactic acid 

following washing each side 

of beef from top to bottom for 

at least 2 minutes with hot 

water and allowing a 5 minute 

drip time after the hot water 

wash. 

Antimicrobial Spray 

Treatments 

for Red Meat 

Carcasses 

Processed in 

Very Small Meat 

Establishments. 

Pennsylvania State 

University. 2005. 

Technical support from 

the manufacturer with 

instructions on mixing 

the lactic acid with 

water to achieve a 

concentration that is 

safe and suitable in 

accordance with:

FSIS Directive 7120.1

In plant monitoring records for 

90 day period recorded on Hot 

Water and Drip Time Monitoring 

Check Sheet (including 

parameters for the time the 

carcass is sprayed with hot 

water, carcass coverage, 

method application (from top to 

bottom and spray nozzle within 

12 inches of carcass), and drip 

time.

Records of lactic acid 

concentration. Trial Reports run 

under specified lactic acid 

critical parameters 

demonstrating complete 

carcass coverage, sufficient 

amount (lactic acid drips off 

carcass), contact time, method 

of application (spray nozzle 

within 12 inches of carcass and 

from top to bottom).
Food Safety and Inspection Service:

Example: Antimicrobial Intervention

46b
Food Safety and Inspection Service:

Example: Antimicrobial Intervention

46c
Food Safety and Inspection Service:

Example: Antimicrobial Intervention

46d

Product Hazard Process Critical Operational Parameters

Initial Validation

Scientific Support Initial In-Plant Data

Beef Carcass Biological –

E. coli

O157:H7, 

Salmonella 

Typhimurium

Chemical -

excessive 

levels of 

lactic acid

Physical -

none

Lactic Acid 

Spray

2% lactic acid applied within 

12 inches of carcass surface 

and entire carcass covered 

using a stainless steel spray 

tank fitted with a pressure 

gauge and air compressor.

Each side of beef should be 

sprayed for at least 1 minute 

and sprayed from top to 

bottom and sufficient lactic 

acid is applied such that 

some of it drips off. 

Note: The entire carcass is 

sprayed with lactic acid 

following washing each side 

of beef from top to bottom for 

at least 2 minutes with hot 

water and allowing a 5 minute 

drip time after the hot water 

wash. 

Antimicrobial Spray 

Treatments 

for Red Meat 

Carcasses 

Processed in 

Very Small Meat 

Establishments. 

Pennsylvania State 

University. 2005. 

Technical support from 

the manufacturer with 

instructions on mixing 

the lactic acid with 

water to achieve a 

concentration that is 

safe and suitable in 

accordance with:

FSIS Directive 7120.1

In plant monitoring records for 

90 day period recorded on Hot 

Water and Drip Time Monitoring 

Check Sheet (including 

parameters for the time the 

carcass is sprayed with hot 

water, carcass coverage, 

method application (from top to 

bottom and spray nozzle within 

12 inches of carcass), and drip 

time.

Records of lactic acid 

concentration. Trial Reports run 

under specified lactic acid 

critical parameters 

demonstrating complete 

carcass coverage, sufficient 

amount (lactic acid drips off 

carcass), contact time, method 

of application (spray nozzle 

within 12 inches of carcass and 

from top to bottom).
Food Safety and Inspection Service:

Are All of the Critical Operational Parameters Being Met?

47

Yes! Best Practice

 Contact

time

 Concentration

(not shown)

 Method of application

 Pressure 

Gauge
• Initial validation should be a distinct function from 

ongoing verification.

• During the 90 calendar day initial validation period 

after completing the hazard analysis and developing 

the HACCP system, establishments validate the 

adequacy of their HACCP system. 

• Following the 90 calendar day initial validation 

period, an establishment uses its findings from the 

initial validation period to fully implement its system 

and solidify its monitoring and on-going verification 

procedures and frequencies. 

Food Safety and Inspection Service:

What is the Difference Between Initial Validation and Ongoing 

Verification?

48
Food Safety and Inspection Service:

What is the Difference Between Initial Validation and Ongoing 

Verification?

49a

Initial 

Validation

•Frequency:

•Once over a period of the 

first 90 days of new or 

revised HACCP system

•Purpose:

•To ensure the HACCP 

system as designed 

functions as intended

•Process:

•Repeatedly test all critical 

operational parameters to 

show the establishment 

can implement them and 

that they are effective at 

preventing or controlling 

the identified hazards

Ongoing Verification

•Frequency

•Ongoing following 

completion of initial 

validation (i.e., day 91) and 

onward

•Purpose:

•To ensure HACCP system 

is functioning as intended 

on an ongoing basis

•Process:

•Conducting ongoing 

verification activities 

including calibration, 

direct observation, and 

review of records as well 

as other independent 

checks such as testing

Reassessment

•Frequency

•Annually and whenever 

changes occur that affect 

the hazard analysis or 

HACCP plan

•Purpose:

•To determine whether the 

HACCP system as designed 

and executed is still 

adequate

•Process:

•Review of records 

generated from ongoing 

verification to ensure that 

the HACCP system as 

designed and executed is 

still adequate (i.e., through 

test results and monitoring 

of critical operational 

parameters)

If reassessment results in no changes

If reassessment results in changes to the HACCP system
Food Safety and Inspection Service:

What is the Difference Between Initial Validation and Ongoing 

Verification?

49b

Initial 

Validation

•Frequency:

•Once over a period of the 

first 90 days of new or 

revised HACCP system

•Purpose:

•To ensure the HACCP 

system as designed 

functions as intended

•Process:

•Repeatedly test all critical 

operational parameters to 

show the establishment 

can implement them and 

that they are effective at 

preventing or controlling 

the identified hazards

Ongoing Verification

•Frequency

•Ongoing following 

completion of initial 

validation (i.e., day 91) and 

onward

•Purpose:

•To ensure HACCP system 

is functioning as intended 

on an ongoing basis

•Process:

•Conducting ongoing 

verification activities 

including calibration, 

direct observation, and 

review of records as well 

as other independent 

checks such as testing

Reassessment

•Frequency

•Annually and whenever 

changes occur that affect 

the hazard analysis or 

HACCP plan

•Purpose:

•To determine whether the 

HACCP system as designed 

and executed is still 

adequate

•Process:

•Review of records 

generated from ongoing 

verification to ensure that 

the HACCP system as 

designed and executed is 

still adequate (i.e., through 

test results and monitoring 

of critical operational 

parameters)

If reassessment results in no changes

If reassessment results in changes to the HACCP system
• As previously explained:

– Establishments will be given time (until January 4, 2016 or April 4, 

2016 depending on their size) to collect the necessary initial in-plant 

validation data.

– FSIS will issue further instructions to IPP on how and when to 

document noncompliance if an establishment lacks initial in-plant 

validation data.

– In the meantime, IPP are to continue to verify initial validation 

requirements following the instructions in FSIS Directive 5000.6 

Performance of the Hazard Analysis Verification (HAV) Task and are not 

to cite the lack of in-plant validation data as the only reason for the 

documentation of noncompliance. 

Food Safety and Inspection Service:

What are the Next Steps for Implementation (Phase 2)?

50
• Initial validation encompasses activities designed to 

determine whether the entire HACCP system is 

functioning as intended. 

• There are two elements to initial validation:

– Element 1: Scientific Support Documentation (Design)

– Element 2: Initial in-plant Demonstration Data (Execution)

• By ensuring that the HACCP system is designed and 

executed properly, establishments can reduce the 

likelihood for product contamination and foodborne 

illnesses in the future. 

Food Safety and Inspection Service:

What Are the Key Points to Take Away?

51
• Establishments are being given time to assemble 

the required initial in-plant validation data.

• In most cases, initial in-plant validation data will 

consist of data related to critical operational 

parameters (not microbiological data).

• IPP are not to cite the lack of in-plant validation 

data as the only reason for the documentation of 

noncompliance until instructions are provided in 

a future issuance. 

Food Safety and Inspection Service:

What Are the Key Points to Take Away?

52