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HACCP Systems and Recall Verification 

Objectives 

After completion of this module, the participant will be able to: 

1. Explain the regulatory process, including the definition of the four 

components, and identify key parts of each component. 

2. Identify the four questions to consider when determining whether to document 

noncompliance when there is failure to meet HACCP regulatory requirements. 

3. Given a scenario, use the regulatory process to determine whether a food 

safety system is inadequate. 

4. State two instances when a verification plan is prepared. 

5. State how to verify the requirements of 9 CFR 418.3 for maintaining written 

recall procedures. 

Regulatory Process 

The HACCP system, referenced in 9 CFR 417.4, is defined in 9 CFR 417.1 as 

“the HACCP plan in operation, including the HACCP plan itself”. The HACCP 

plan in operation includes the: 

• hazard analysis, 

• HACCP plan, 

• supporting documentation including prerequisite programs used to make 

decisions in the hazard analysis, and 

• HACCP records generated on an ongoing basis. 

IPP must focus on the overall effectiveness of the establishment’s HACCP 

system. 

Inspection Methods 

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Active Learning Activity: Consider what you’ve already learned about the Regulatory Process and 

work with your neighbors to complete the diagram. 

3. 

? 

Yes 5. 

? 

Yes 

6. 

No 

No 

4. 

Stop 7. 

2. 

Task 

8. Follow 

ROP 

1. 

Task 

 

 

 

 

 

 

 

 

9. Notify

District 

Office 

through 

supervisory 

Channels 

10. District 

Office will 

determine 

appropriate

enforcement 

action based 

on the ROP 

Inspection Methods 

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The diagram on the previous page shows the HACCP Regulatory Process, 

which includes the following four components: 

• Inspection Methodology 

 Performing HACCP inspection tasks 

 Verifying specific HACCP regulatory requirements during the 

performance of the HACCP inspection task 

• Decision-making (GAD) 

 Gathering information, making observations, reviewing documentation, 

assessing the gathered information and arriving at a supportable 

compliance or noncompliance determination. 

• Documentation 

 Entering HACCP inspection task results (observations and 

determinations) in PHIS 

 Documenting noncompliance on a Noncompliance Record 

 Associating noncompliance from the same cause 

• Enforcement 

 Following the Rules of Practice (ROP) 

 Providing the establishment with due process 

FSIS Responsibilities 

FSIS responsibilities for verifying an establishment’s food safety system are 

outlined in FSIS Directive 5000.1, Rev. 6 and 5000.6, Rev. 4. You are 

responsible for understanding and properly performing the HACCP inspection 

tasks in the Public Health Information System (PHIS) as described in these 

Directives. 

Inspection Methodology 

IPP perform two HACCP inspection tasks to verify that establishments are 

complying with 9 CFR Part 417. The Hazard Analysis Verification (HAV) task 

directs the IPP to review the establishment’s hazard analyses for one HACCP 

plan, prerequisite programs, and other supporting documentation. The HACCP 

verification task focuses the attention of the IPP on the execution or 

implementation of the establishment’s HACCP plans, prerequisite programs and 

other supporting programs. Both of the HACCP verification tasks can be 

performed as a routine or directed task. Each HACCP task has two verification 

components: 

• A recordkeeping component, and 

• A review and observation component 

IPP use either component or a combination of the components to verify 

regulatory compliance. 

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Regulatory Decision-Making- A Thought Process 

When IPP perform both of the HACCP inspection tasks, they need to use the 

regulatory thought process described below. 

Gather, Assess, and Determine or GAD 

IPP are to gather all available information to help them determine regulatory 

compliance by: 

• Reviewing establishment hazard analyses, HACCP plans, prerequisite 

programs and other supporting documentation 

• Reviewing establishment records documenting the implementation of 

HACCP plans, prerequisite programs and other supporting programs or 

procedures 

• Observing establishment employees implementing each HACCP plan, 

prerequisite program or other supporting program or procedure, and 

• Observe product and occasionally take measurements as specified in the 

establishment HACCP plans, prerequisite programs, or other supporting 

programs or procedures. 

IPP are to assess the significance and meaning of information gathered by: 

• Comparing the information gathered to HACCP regulatory requirements 

• Considering what each piece of information, either taken separately or 

with other findings, says about how the HACCP system is functioning to 

ensure that products are not adulterated 

• Considering the information in the context of past findings to identify any 

patterns or trends, e.g., Is this an isolated or recurring problem? Are 

conditions getting worse? Is the establishment responding effectively and 

in a timely manner to problems? 

IPP are to determine whether the information supports a finding of regulatory 

compliance by considering the following questions: 

• Has adulterated product been produced or shipped? 

• Is the HACCP system effectively controlling the relevant food safety 

hazards? 

• Has the establishment failed to meet one or more HACCP regulatory 

requirements? 

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HACCP noncompliance is the failure to meet any of the HACCP regulatory 

requirements of 9 CFR Part 417. If a HACCP noncompliance occurs, the 

establishment is expected to take immediate and further planned actions or come 

back into compliance. 

Before IPP determine whether or not they should document the failure to meet 

the HACCP regulatory requirements as a noncompliance, they should consider 

the following questions: 

1. Has the establishment already identified the failure to meet regulatory 

requirements or deviation from a critical limit? 

Note: A deviation from a critical limit is the failure to meet the applicable 

value established for the CCP. 

2. If product is involved, has the establishment ensured product safety? 

3. Has the establishment taken immediate and further planned actions to 

correct the failure to meet regulatory requirements, or has it taken 

corrective actions to address the deviation in accordance with 9 CFR 

417.3? 

4. Is a trend developing (i.e., has the establishment carried out the actions in 

1 through 3 above for similar situations)? 

Note: When answering these questions, it may be necessary for the IPP to 

gather additional information, e.g., records. 

If the answer is “yes” to questions 1, 2, and 3 and “no” to question 4, then 

there is no noncompliance because the establishment has already identified and 

addressed the situation. IPP document compliance with the applicable 

regulations in PHIS. Because the establishment’s response provided the further 

planned actions and preventive measures for the noncompliance or deviation, 

not writing an NR does not adversely affect an IPP’s ability to track developing 

trends. However, an establishment’s failure to follow through on further planned 

actions and preventive measures could lead to recurring noncompliances and 

would warrant NRs in recurring situations. 

If the answer is “no” to questions 1, or 2, or 3, or “yes” to question 4, then a 

noncompliance exists. IPP document noncompliance in PHIS and generate an 

NR. 

Note: If IPP are uncertain whether the information supports a particular 

compliance determination, they are to discuss the issue with their supervisor. 

Once a sound determination has been made, IPP are to document their 

determination in accordance with FSIS Directive 5000.1. 

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Noncompliance as it Relates to the HACCP System 

While any noncompliance is important and must be properly documented, the 

purpose of the HACCP verification task is more than just to identify isolated 

instances of noncompliance. IPP must also consider what their findings, whether 

positive, negative, or inconclusive, suggest about the overall effectiveness of the 

establishment’s HACCP system. When IPP have concerns about the ability of 

the establishment’s HACCP system to produce safe products, they are to discuss 

those concerns with their supervisor. 

It is important that IPP consider each piece of information in the context of 

the HACCP system and the potential for product adulteration. The following 

questions will help IPP to consider the significance of each finding for the 

HACCP system: 

• Is this piece of information part of a pattern? For example, suppose 

the establishment skipped a measurement for a prerequisite program. Is 

this an isolated incident or has the establishment regularly failed to 

implement their prerequisite programs? 

• Is there other information to indicate that the HACCP system is 

working or is not working? For example, an establishment’s prerequisite 

program specifies product will be received with supplier certificates of 

analysis (COA) and periodically tested. If the establishment failed to 

receive a COA for a particular product, how did they respond on whether 

or not to use the product? 

• Does the information seem to agree with the other available 

information about the food safety system? For example, the 

establishment uses a prerequisite program to prevent a hazard in 

incoming products, and the records appear to show that a particular 

hazard is being prevented. However, the establishment’s testing of 

finished product for the particular hazard finds positive results. 

• Do these results support each other or is there an apparent 

contradiction? For example, an establishment that uses a prerequisite 

program to prevent E. coli O157:H7 in incoming beef has certificates of 

analysis and verification test results on incoming trim that appear to 

indicate that the hazard is not reasonably likely to occur, but the 

establishment gets a positive test result on a finished product lot. The 

finished product test result calls into question the effectiveness of the 

prerequisite program as means of supporting the decision that E. coli 

O157:H7 is not reasonably likely to occur. 

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HACCP Systems and Recall 

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Inadequate SystemDetermination 

If noncompliance is found, you need to determine if it indicates an inadequate 

system. 

5. 

Inadequate 

System? 

Sec. 417.6 - Inadequate HACCP Systems. 

A HACCP system may be found to be inadequate if: 

(a) The HACCP plan in operation does not meet the requirements set forth in 

this part; 

(b) Establishment personnel are not performing tasks specified in the HACCP 

plan; 

(c) The establishment fails to take corrective actions, as required by Sec. 

417.3 of this part; 

(d) HACCP records are not being maintained as required in Sec. 417.5 of this 

part; or 

(e) Adulterated product is produced or shipped. 

To determine whether an establishment’s HACCP system is adequate, you must 

consider more than the HACCP plan. Consider all available evidence, including 

the hazard analysis, supporting documentation, and other parts of the system 

(SSOP, in-plant testing programs, etc.). Depending on the problems identified, 

the establishment may need to reassess the hazard analysis and HACCP plan. 

For example, if an establishment has not identified E. coli O157:H7 as a food 

safety hazard reasonably likely to occur in its process, is testing outside the 

HACCP plan or SSOP, and gets a positive result, then a reassessment of its 

HACCP plan and hazard analysis is required by 9 CFR 417.4(a)(3). The 

establishment must support the decisions made during the reassessment as 

specified in 417.5(a)(1)&(2). 

If the establishment did not reassess its HACCP plan and hazard analysis as 

required by 417.3(b)(4) and 417.4(a)(3)(i) or does not have supporting 

documentation required by 417.5(a)(1)&(2), you cannot determine that the 

HACCP system is meeting the requirements of 417.2, therefore the HACCP 

system may be determined to be inadequate as described in 417.6. 

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417.3(b)(4) & 417.4(a)(3)(i) 

417.5(a)(1)&(2) 

417.2 

417.6 

To determine if there is an inadequate system you need to answer the following: 

1. Does the HACCP plan meet the regulatory requirements of Part 417? 

If the establishment is not implementing all or some of its program, it has not met 

regulatory requirements. For example, if an establishment is not maintaining any 

records associated with its HACCP plan, the establishment is not monitoring 

critical limits at any CCP, the establishment did not reassess the HACCP plan 

when required, or the establishment did not modify its HACCP plan when it no 

longer met the requirements---then the establishment has not met the regulatory 

requirements. Therefore, you are unable to determine whether or not the 

establishment is producing un-adulterated product, and, therefore the HACCP 

system is inadequate. In these cases, the HACCP system would be considered 

inadequate because it did not meet the regulatory requirements of Part 417. 

- If the answer is no to question 1, this may be indicative of an inadequate 

system. 

2. Was adulterated product produced or shipped? 

If the HACCP system did not prevent the production and distribution of 

adulterated product, it is an inadequate system. If you determine that the 

establishment failed to meet a critical limit for a CCP and did not take the 

corrective actions as per Section 417.3 of the Federal regulations, and the 

establishment has performed its pre-shipment review, the HACCP system is 

inadequate. 

- If the answer is yes to question 2, this may be indicative of an inadequate 

system. 

3. Is there a trend in establishment noncompliance? 

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You should observe trends in the regulations cited on NRs when determining 

whether an establishment’s HACCP system is inadequate. If two or more NRs 

have the same regulations cited and if descriptions of noncompliances indicate 

that similar problems are recurring, there may be a trend indicating the HACCP 

system is inadequate. 

There is no specific number of incidents which determine a trend. Because 

there will be a variety of processing environments and HACCP plans, FSIS 

cannot establish that a specific number of the same or similar incidents of 

noncompliance necessarily support an inadequate system. Therefore, you must 

thoroughly analyze and document noncompliance trends that may support a 

determination. When reviewing a possible trend in noncompliance, you must 

closely review the descriptions of noncompliance contained in Block 10 of the NR 

form. You should not solely rely on the number of linked noncompliances. Only 

through careful analysis of the regulations cited and the written descriptions of 

noncompliance can you determine whether there is a trend indicating that a 

HACCP system may be inadequate. 

- If the answer is yes to question 3, this may be indicative of an inadequate 

system. 

Action to Take If an Inadequate System Exists 

If you determine that an inadequate system exists, then you must take action. 

• You would notify the District Office. 

• If you determine that adulterated product has been produced and shipped, 

you would take an immediate withholding action, according to the Rules of 

Practice. 

The main point to remember is to contact the District Office, via supervisory 

channels, if you believe an inadequate system exists. 

Documentation 

Completinga Noncompliance Record(NR) 

When documenting noncompliance on a Noncompliance Record (NR), do the 

following. 

• Identify each noncompliance. 

• Be specific and thorough, including time and location. 

• Explain that establishment management has received notification. 

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• State any regulatory control actions you took. 

If you need further information about completing the NR, please consult FSIS 

PHIS Directive 5000.1 and the PHIS User Guide. 

Documenting a Trend 

Throughout this course you have learned that when you observe noncompliance, 

you document noncompliance, and when there is a trend in noncompliance that 

is from the same cause you associate the noncompliances. Documenting and 

associating noncompliance are key concepts that must be carried out in your 

daily duties so that the agency is able to provide establishments with due 

process and to take enforcement action when necessary. 

When you determine that the establishment does not meet one or more 

regulatory requirements, document your findings on an NR. If the establishment 

has produced and shipped unsafe food, initiate the appropriate enforcement 

actions described in §500.3. If you have documented multiple or recurring 

noncompliances, request that the DO issue an NOIE (Notice of Intended 

Enforcement Action) to the establishment as per §500.4. If you decide to request 

an NOIE it should come as no surprise. By the time you have made this 

decision, you should have been discussing the trend in noncompliance with the 

establishment during weekly meetings and you should have been keeping your 

frontline supervisor apprised of what was happening. Everyone (the 

establishment, your frontline supervisor, and the DO) should be expecting the 

request for the NOIE. 

Enforcement 

Follow Rules of Practice 

Recall that the Rules of Practice (ROP) in 9 CFR 500 provide establishments 

with due process. They also describe how the Agency progresses with further 

enforcement actions and under what circumstances. 

When a noncompliance determination is made, it may be necessary to take an 

enforcement action to prevent adulterated product from being produced and 

shipped. In accordance with the rules of practice, this enforcement action could 

be one of three types. 

1. A “regulatory control action,” is the retention of product, rejection of 

equipment or facilities, slowing or stopping of lines, or refusal to allow the 

processing of specifically identified product. 

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2. A “withholding action,” is the refusal to allow the marks of inspection to be 

applied to products. A withholding action may affect all product in the 

establishment or product produced by a particular process. 

3. A “suspension,” is an interruption in the assignment of program employees to 

all or part of an establishment. 

Withholding actions affect whether the mark of inspection may be applied, while 

suspensions affect whether inspection verification activities will be performed. 

Regulatory Control Actions 

FSIS may take a regulatory control action if there are: (1) insanitary conditions or 

practices; (2) product adulteration or misbranding; (3) conditions that preclude 

FSIS from determining that product is not adulterated or not misbranded; or (4). 

inhumane handling or slaughtering of livestock. 

A regulatory control action permits IPP to identify regulatory noncompliance and 

prevent the movement of the product involved or use of the equipment or facility 

involved until the noncompliance has been corrected. IPP are not required to 

give the establishment prior notification that they are about to execute a 

regulatory control action. 

If there is SPS noncompliance without direct product contamination or 

adulteration, but there is an imminent probability that the noncompliance will 

result in product contamination or adulteration if not addressed immediately, you 

will take a regulatory control action such as retaining product or rejecting the 

equipment or room with a tag, and then complete an NR. Regulatory control 

actions should remain in effect until the establishment has brought itself back into 

compliance with regulations. 

If there is SPS or SSOP noncompliance with direct product contamination or 

adulteration, you will verify that the establishment addresses the noncompliance 

by meeting the requirements of either Part 416 or Part 417. You will write an NR 

using the appropriate SSOP regulations or the appropriate HACCP regulations. 

You will verify that the establishment implements corrective actions, including 

product control actions that meet the requirements of §416.15. The 

establishment may need to re-evaluate the effectiveness of its procedures in its 

SSOP and modify them if they are no longer effective in preventing direct 

contamination or adulteration of product. 

If the direct product contamination poses a food safety hazard, you will verify that 

the establishment implements corrective actions, including product control 

actions, that meet the requirements of §417.3(b). These corrective actions 

include a reassessment to determine whether the unforeseen hazard should be 

incorporated into the HACCP plan. Regulatory control actions are not frequently 

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used for HACCP regulatory noncompliance unless control is necessary to 

prevent shipment of contaminated or adulterated product. 

Examples of common regulatory control actions related to slaughter would be 

stopping a line or retaining a carcass as a result of a slaughter food safety 

standard finding. 

Withholding Action Without Prior Notice 

There may be instances when it is necessary for you to take immediate 

enforcement actions to prevent imminent threat to public health, without giving 

the establishment prior notice. For example, if the establishment produced and 

shipped adulterated product, you would need to take an immediate withholding 

action. In these situations, first take the immediate withholding action, and then 

as soon as possible notify the District Office and your supervisor. For further 

information, refer to the Rules of Practice module. 

Withholding and Suspension Actions With Prior Notification 

Keep in mind that some withholding and suspension actions require prior 

notification according to the rules of practice. The most common withholding or 

suspension actions related to HACCP noncompliance are those in which the 

HACCP system is found inadequate due to multiple or recurring 

noncompliances. Withholding or suspending inspection for this cause does 

require prior notification to the establishment. The prior notice is in the form of a 

written Notice of Intended Enforcement Action (NOIE). Remember that a 

suspension may only be issued by a District Manager or higher FSIS official. 

Notify the District Office 

If you determine that an inadequate system may exist, you should notify the 

District Office. Provide the DO with all of the information about the situation. You 

should request that a Notice of Intended Enforcement be issued to the 

establishment. The DO will provide direction about further actions you need to 

take. The DO may assign an EIAO to evaluate the establishment’s HACCP 

system. 

District Office Determines Enforcement Action 

After evaluating all of the facts of the case, the District Office will determine the 

appropriate enforcement action based upon the rules of practice. 

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-

~ 

/ \ 1 • 

----+ 

~ 

l " 

1 

t ~ -

HACCP Systems and Recall 

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FSIS defers 

enforcement to allow 

the establishment to 

implement proposed 

corrective actions 

Notice of Intended Enforcement Action 

Establishment has 3 business days to respond 

Establishment responds

including proposed 

corrective actions 

Establishment doesnot 

respond to the NOIE 

Establishment’s 

response does

not adequately

address the 

issues addressed 

in the NOIE 

FSIS prepares a verification plan

based on the establishment’s 

proposed corrective actions 

Corrective actions are 

implemented by the

establishment and are 

effective. FSIS closes out 

the NOIE with a Letter of 

Warning (LOW) 

FSIS suspends the 

assignment of program 

employees to all or part of the 

establishment 

Establishment responds

including proposed 

corrective actions 

FSIS holds the suspension in

abeyance to allow the 

establishment time to 

implement proposed corrective 

actions 

Establishment’ 

s response

does not 

adequately

address the 

issues in the 

NOS. The 

suspension 

remains in 

effect until the 

issues in the 

NOS are 

adequately 

addressed 

Corrective 

actions are 

implemented

by the 

establishment 

and are 

effective. FSIS 

closes out the 

suspension

with a Letter 

of Warning 

(LOW) 

Corrective actions were either 

not fully implemented or were 

ineffective. FSIS closes out the 

NOIE by suspending the 

assignment of program

employees to all or part of the 

establishment 

Corrective actions were either 

not fully implemented or were 

ineffective. FSIS reinstates the 

suspension 

FSIS prepares a verification 

plan based on the 

establishment’s proposed 

corrective actions 

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VerificationPlan 

When FSIS defers an enforcement action or holds a suspension in abeyance, 

FSIS allows the establishment time to implement their proposed corrective 

actions. A verification plan (VP) is developed by the EIAO with input from the inplant inspection team and the Frontline Supervisor. The VP captures all of the 

corrective actions the establishment stated they would do, and the VP provides a 

systematic means for FSIS to verify that an establishment is effectively 

implementing the corrective measures that were proffered to FSIS. 

A VP: 

• Describes the verification activities to be performed by inspection personnel 

based on the establishment’s corrective measures, 

• Lists the procedures for each verification activity, and 

• Identifies the regulatory citation for each verification activity. 

IPP schedule and perform directed verification activities identified in the VP. On a 

weekly basis, the in-plant team reports, via e-mail to the District Office, the 

results of the activities conducted under the VP. The in-plant inspection team has 

the flexibility to increase the frequency of the verification activities based on its 

findings. Any failure to meet the conditions of the proposed corrective measures 

would support FSIS imposing further enforcement actions. 

Recalls 

Recalls are initiated when there is evidence of adulterated or misbranded product 

in commerce, for example, when a positive pathogen sample result is obtained 

for product that the establishment has shipped. FSIS Directive 8080.1, Rev. 7, 

Recall of Meat and Poultry Products, details all verification requirements for 

recalls. 

Establishment Recall Requirements 

On May 8, 2012, FSIS published the final rule “Requirements for Official 

Establishments to Notify FSIS of Adulterated or Misbranded Product, Prepare 

and Maintain Written Recall Procedures, and Document Certain Hazard Analysis 

and Critical Control Points System Plan Reassessments” (77 FR 26929). The 

rule requires official establishments to: 

1. Notify the local FSIS District Office within 24 hours of learning or 

determining that an adulterated or misbranded meat or poultry product 

received by or originating from the official establishment has entered 

commerce (9 CFR 418.2); 

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2. Prepare and maintain written procedures for the recall of all meat and 

poultry products produced and shipped by the establishment (9 CFR 418.3); 

and 

3. Prepare written recall procedures as required by 9 CFR 418.3 before being 

granted Federal inspection (9 CFR 304.3(a) and 381.22(a)) 

9 CFR 418.2 - Notification. 

Each official establishment must promptly notify the local FSIS District Office 

within 24 hours of learning or determining that an adulterated or misbranded 

meat, meat food, poultry, or poultry product received by or originating from the 

official establishment has entered commerce, if the official establishment 

believes or has reason to believe that this has happened. The official 

establishment must inform the District Office of the type, amount, origin, and 

destination of the adulterated or misbranded product. 

Establishments must notify the District Office that an adulterated or misbranded 

meat or poultry product received by or originating from the official establishment 

has entered commerce. Official establishments are to provide the DO with the 

type, amount, origin, and destination of the adulterated or misbranded product. 

1. Product is in commerce if it is out of the producing establishment’s direct 

control and is in distribution (e.g., in a warehouse, distribution center, retail 

facility, restaurant, or other institution). 

2. The 24-hour period begins when an establishment has reason to believe 

that a product in commerce is adulterated or misbranded under the Federal 

Meat Inspection Act (FMIA) or the Poultry Products Inspection Act (PPIA). 

For example, product would be adulterated if the final results of a laboratory 

analysis show that raw ground beef contains E. coli O157:H7, or if product 

contains an allergen that is not declared on the product label. 

3. There may be situations in which laboratory results are not available, but 

based on epidemiological evidence, there may be a probability of harm from 

consuming the product. Under these circumstances, official establishments 

are to consider the strength of the epidemiological evidence to determine 

whether there is reason to believe that the product is adulterated or 

misbranded. 

The DO is to notify the Recall Management and Technical Analysis Division 

(RMTAD) as soon as possible after notification. If establishments contact other 

FSIS personnel, those employees are to contact RMTAD promptly through 

supervisory channels. 

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The DO and possibly the RMTAD evaluate each situation on a case-by-case 

basis (see FSIS Directive 8080.1). The RMTAD is notified immediately if product 

has left the establishment’s control, and they coordinate any recall activities. 

More or less product may be determined to be “affected product” based on all 

considered factors (e.g., whether some or all products produced under the same 

or a substantially similar HACCP plan have been affected, what pathogens are 

involved, whether there have been any other incidents of contamination in the 

establishment associated with the pathogen, and whether there have been 

persistent and recurring noncompliances in the establishment). The RMTAD is 

notified so a press release can be issued and effectiveness checks can be 

performed. 

The establishment is expected to perform a voluntary recall of any unsafe 

product in commerce. If the establishment does not voluntarily recall product, 

the DO will coordinate actions to detain or seize affected product. 

9 CFR 418.3 - Preparation and maintenance of written recall procedures. 

Each official establishment must prepare and maintain written procedures for the 

recall of any meat, meat food, poultry, or poultry product produced and shipped 

by the official establishment. These written procedures must specify how the 

official establishment will decide whether to conduct a product recall, and how 

the establishment will effect the recall, should it decide that one is necessary. 

Meat and poultry establishments must have written procedures for the recall of 

any meat or poultry product produced and shipped by the official establishment. 

FSIS Directive 5000.8, Rev. 2, Verifying Compliance with Requirements for 

Written Recall Procedures, outlines the details of how to verify the requirements 

of 9 CFR 418.3. 

FSIS Verification 

At least once a year, IPP are to perform a directed Other Inspection 

Requirements task to verify that establishments have written recall procedures. 

If IPP determine that the establishment has written recall procedures, they are to 

document in PHIS that they performed the task, and that the establishment 

complies with 9 CFR 418.3. If IPP determine that the establishment does not 

have written recall procedures, they are to document the noncompliance in PHIS 

on a noncompliance record, citing 9 CFR 418.3. 

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HACCP Regulatory Process 

Inspection Regulatory 

Methodology Decision-making Documentation Enforcement 

3. 

Noncompliance 

Found? 

Yes 5. 

Inadequate 

System? 

Yes 6. Complete 

NR 

No 

No 

4. 

Stop 7. Complete 

NR 

2. Perform HACCP 

verification Task 

8. Follow 

ROP 

1. Perform 

HAV 

Task 

9. Notify

District 

Office 

through 

supervisory 

Channels 

10. District 

Office will 

determine 

appropriate 

enforcement 

action based 

on the ROP 

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Workshop: Regulatory Review 

Refer to the module and to FSIS Directive 5000.1 to complete the following questions. 

1. You are the IIC at a small establishment that produces frozen spaghetti and tomato 

sauce with meat entrees and frozen non-amenable spaghetti entrees made with a 

lobster cheese sauce. You are performing Pre-Operational Sanitation Review and 

Observation Task. 

a. The regulation sections that you are verifying regulatory compliance with are? 

You observe various product contact surfaces in the formulation area. You see that 

some of the blending equipment appears to have product residue from the previous 

day’s production. You inspect the interior surfaces of the blenders and find residue. 

You see what appears to be cheese sauce residue in several areas, and you see what 

appears to be tomato sauce residue in several other areas. You check the production

records from the previous day and determine that the establishment produced lobster 

cheese spaghetti in the morning and tomato sauce with meat spaghetti in the afternoon. 

The label of the spaghetti containing meat does not list any lobster (crustacean) or milk 

ingredients. 

b. Are the conditions you observed creating an insanitary condition? 

c. Can the conditions you observed lead to contaminated product? 

d. Is there a food safety hazard associated with the contamination you observed? 

e. You take official control of the blenders by placing a U.S. reject tag on them. What 

regulations give you the authority to take this action? 

f. What statutes give you the authority to take this action? Explain in your own words the 

reasoning behind this authority. 

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g. What actions would you take next? 

You review the HACCP plan and hazard analysis. The establishment found that food 

allergens were potential food safety hazards, but determined that they were not likely to

occur in this process because the establishment has a food allergen control program 

which prevents the hazard. 

h. Which corrective action regulation would apply in this situation? 

As part of a Directed Fully Cooked but Not Shelf Stable HACCP Verification Task, you 

review the establishment’s food allergen control program. You find that the 

establishment lists several daily in-plant checks and verification activities and the

associated documentation that will be kept. You request recent records and your review 

reveals that the food allergen control program verification activities are not being done at 

the frequency listed in the program. Records are also not available for some of the 

days. 

i. Could this indicate an inadequate system? 

j. How would you document what you have found? What regulations would you use? 

k. What actions would you take next? 

2. While performing a Fully Cooked Not Shelf Stable HACCP verification task in a readyto-eat product operation to verify the HACCP regulatory requirements, you review the 

establishment’s HACCP plan. During this review, you notice that the establishment has 

documented a reassessment of its HACCP plan. You go to establishment management 

and ask what event triggered the reassessment. The establishment manager indicates 

that the reassessment was performed in response to a positive Listeria monocytogenes

result from its microbiological testing of the finished ready-to-eat ham lunchmeat. This 

microbiological testing program is not referenced in the establishment’s HACCP plan. 

Listeria monocytogenes testing is performed as a verification requirement for their 

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customer. You request the establishment to provide the results of their microbiological 

testing of the finished ham lunchmeat. The establishment provides this data to you.

You observe that the last sample analyzed was found to be positive for Listeria 

monocytogenes. You request information about corrective actions taken and are shown 

an unforeseen hazard log that documents that the establishment segregated and held 

affected product. The establishment also has records to show that it performed a review 

to determine the acceptability of affected product, and took action to ensure that no 

product injurious to health entered commerce by denaturing and disposing of the

adulterated product. Documentation that the product was denatured and disposed of in 

a landfill is provided. The log further shows that a reassessment was performed, and the 

establishment determined that this was not a hazard reasonably likely to occur in its 

process. It made no alterations to the hazard analysis or the HACCP plan. The basis for 

this decision is documented as: “It is the only positive ever received. We apply a full

lethality treatment and apply our Sanitation Standard Operating Procedures daily. The 

application of our Sanitation Standard Operating Procedures daily should continue to be 

sufficient in the future. This result is a fluke. No changes to the HACCP plan are 

necessary at this point.” When you ask for support for the decision that the hazard is still 

not reasonably likely to occur, the establishment manager says “the result was a fluke” 

and we documented that on the corrective action log. As part of the Fully Cooked Not 

Shelf Stable HACCP Verification Task on this specific production, you verify that all 

HACCP requirements, including pre-shipment review, were met for all CCPs, other than 

what is described above. 

a. Has the establishment supported its decision about the results of the reassessment? 

b. What are the 4 questions you would seek answers to as you gather information to 

determine whether or not to document this as a noncompliance, and what conclusion 

would you make? 

Remember the 4 questions from the HACCP Regulatory Process presentation. If the

system is working, you may not document some noncompliances. 

c. What regulations need to be considered? 

d. Is there a noncompliance? Please explain your answer. 

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e. If you determine that a noncompliance should be documented, what regulation would

you cite? 

f. What are the questions you would seek answers to as you gather information to 

determine whether or not there is an inadequate system, and what conclusion would you 

make? 

Is there an indication of an inadequate system? 

g. If you determine that you would document an NR, please complete blocks 6, 8, 9, and 

10 only on the next page. 

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The request for this information is voluntary. It is needed to monitor defects found in this inspection system. It is used by FSIS to 

determine whether establishments are in compliance. 9 CFR 301 and 9 CFR 381. FORM APPROVED OMB No. 0583-0089. OMB

DISCLOSURE STATEMENT: Public reporting burden for this collection of information is estimated to average 7 minutes per response, 

including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing

and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of

information, including suggestionsfor reducing this burden, to Department of Agriculture, Clearance Officer, OIRM, Room 404-W, 

Washington, DC 20250: and to the Office of Information and Regulatory Affairs, Office of Management and Budget. 

U.S. Department of Agriculture TYPE OF NONCOMPLIANCE 

FOOD SAFETY AND INSPECTION SERVICE 

NONCOMPLIANCE RECORD  Food Safety  Other Consumer Protection 

1. DATE 2. RECORD NO. 3. ESTABLISHMENT NO. 

4. TO (Name and Title) 5. PERSONNEL NOTIFIED 

6. RELEVANT REGULATIONS 6a. ASSOCIATED NR(s) 

7. TITLES OF HACCP OR SSOP PLAN or OTHER SUPPORTING 7a. NAME OF CCP(S) or PREREQUISITE PROGRAM 

DOCUMENTATION 

8. INSPECTION TASK 9. VERIFICATION ACTVITY 

 Review & Observation  Recordkeeping  Both 

9a. AFFECTED PRODUCT INFORMATION 

9b. RETAIN/REJECT TAGS 

10. DESCRIPTION OF NONCOMPLIANCE 

11. SIGNATURE OF INSPECTION PROGRAM EMPLOYEE 

You are hereby advised of your right to appeal this decision as delineatedby 306.5 and/or 381.35 of 9 CFR 

12. PLANT MANAGEMENT RESPONSE: 

This document serves as written notification thatyour failure to comply with regulatory requirement(s) could result in additional regulatory or 

administrative action. 

13. SIGNATURE OF PLANT MANAGEMENT 14. DATE 

15. VERIFICATION SIGNATURE OF INSPECTION PROGRAM EMPLOYEE 16. DATE 

FSIS FORM 5400-4 DISTRIBUTION: Original & 1 Copy to Establishment, 1 Copy 

to Inspector 

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Appendix 

FSIS Directives and Notices 

FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System 

FSIS Directive 5000.6, Performance of the Hazard Analysis Verification (HAV) 

Task 

FSIS Directive 5000.8, Verifying Compliance with Requirements for Written 

Recall Procedures 

FSIS Directive 8080.1, Recall of Meat and Poultry Products. 

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Appendix 2 

TITLE 9--ANIMALS AND ANIMAL PRODUCTS 

CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT 

OF 

AGRICULTURE 

PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) 

SYSTEMS 

Sec. 

417.1 Definitions. 

417.2 Hazard Analysis and HACCP plan. 

417.3 Corrective actions. 

417.4 Validation, Verification, Reassessment. 

417.5 Records. 

417.6 Inadequate HACCP Systems. 

417.7 Training. 

417.8 Agency verification. 

Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C. 1901-1906; 7 CFR 2.18, 

2.53. 

Source: 61 FR 38868, July 25, 1996, unless otherwise noted. 

Sec. 417.1 Definitions. 

For purposes of this part, the following definitions shall apply: 

Corrective action - Procedures to be followed when a deviation occurs. 

Critical control point - A point, step, or procedure in a food process at which control can 

be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced 

to acceptable levels. 

Critical limit- The maximum or minimum value to which a physical, biological, or 

chemical hazard must be controlled at a critical control point to prevent, eliminate, or 

reduce to an acceptable level the occurrence of the identified food safety hazard. 

Food safety hazard- Any biological, chemical, or physical property that may cause a food 

to be unsafe for human consumption. 

HACCP System- The HACCP plan in operation, including the HACCP plan itself. 

Hazard - SEE Food Safety Hazard. 

Preventive measure - Physical, chemical, or other means that can be used to control an 

identified food safety hazard. 

Process-monitoring instrument - An instrument or device used to indicate conditions 

during processing at a critical control point. 

Responsible establishment official-The individual with overall authority on-site or a 

higher level official of the establishment. 

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Sec. 417.2 Hazard Analysis and HACCP Plan. 

(a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted 

for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in 

the production process and identify the preventive measures the establishment can apply 

to control those hazards. The hazard analysis shall include food safety hazards that can 

occur before, during, and after entry into the establishment. A food safety hazard that is 

reasonably likely to occur is one for which a prudent establishment would establish 

controls because it historically has occurred, or because there is a reasonable possibility 

that it will occur in the particular type of product being processed, in the absence of those 

controls. (2) A flow chart describing the steps of each process and product flow in the 

establishment shall be prepared, and the intended use or consumers of the finished 

product shall be identified. (3) Food safety hazards might be expected to arise from the 

following: 

(i) Natural toxins; 

(ii) Microbiological contamination; 

(iii) Chemical contamination; 

(iv) Pesticides; 

(v) Drug residues; 

(vi) Zoonotic diseases; 

(vii) Decomposition; 

(viii) Parasites; 

(ix) Unapproved use of direct or indirect food or color additives; and 

(x) Physical hazards. 

(b) The HACCP plan. (1) Every establishment shall develop and implement a written 

HACCP plan covering each product produced by that establishment whenever a hazard 

analysis reveals one or more food safety hazards that are reasonably likely to occur, 

based on the hazard analysis conducted in accordance with paragraph (a) of this section, 

including products in the following processing categories: 

(i) Slaughter--all species. 

(ii) Raw product--ground. 

(iii) Raw product--not ground. 

(iv) Thermally processed--commercially sterile. 

(v) Not heat treated--shelf stable. 

(vi) Heat treated--shelf stable. 

(vii) Fully cooked--not shelf stable. 

(viii) Heat treated but not fully cooked--not shelf stable. 

(ix) Product with secondary inhibitors--not shelf stable. 

(2) A single HACCP plan may encompass multiple products within a single processing 

category identified in this paragraph, if the food safety hazards, critical control points, 

critical limits, and procedures required to be identified and performed in paragraph (c) of 

this section are essentially the same, provided that any required features of the plan that 

are unique to a specific product are clearly delineated in the plan and are observed in 

practice. 

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(3) HACCP plans for thermally processed/commercially sterile products do not have to 

address the food safety hazards associated with microbiological contamination if the 

product is produced in accordance with the requirements of part 318, subpart G, or part 

381, subpart X, of this chapter. 

(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum: 

(1) List the food safety hazards identified in accordance with paragraph (a) of this 

section, which must be controlled for each process. 

(2) List the critical control points for each of the identified food safety hazards, 

including, as appropriate: 

(i) Critical control points designed to control food safety hazards that could be 

introduced in the establishment, and 

(ii) Critical control points designed to control food safety hazards introduced outside 

the establishment, including food safety hazards that occur before, during, and after entry 

into the establishment; 

(3) List the critical limits that must be met at each of the critical control points. Critical 

limits shall, at a minimum, be designed to ensure that applicable targets or performance 

standards established by FSIS, and any other requirement set forth in this chapter 

pertaining to the specific process or product, are met; 

(4) List the procedures, and the frequency with which those procedures will be 

performed, that will be used to monitor each of the critical control points to ensure 

compliance with the critical limits; 

(5) Include all corrective actions that have been developed in accordance with Sec. 

417.3(a) of this part, to be followed in response to any deviation from a critical limit at a 

critical control point; and 

(6) Provide for a recordkeeping system that documents the monitoring of the critical 

control points. The records shall contain the actual values and observations obtained 

during monitoring. 

(7) List the verification procedures, and the frequency with which those procedures 

will be performed, that the establishment will use in accordance with Sec. 417.4 of this 

part. 

(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and 

dated by the responsible establishment individual. This signature shall signify that the 

establishment accepts and will implement the HACCP plan. 

(2) The HACCP plan shall be dated and signed: 

(i) Upon initial acceptance; 

(ii) Upon any modification; and 

(iii) At least annually, upon reassessment, as required under Sec. 417.4(a)(3) of this 

part. 

(e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an establishment to 

develop and implement a HACCP plan that complies with this section, or to operate in 

accordance with the requirements of this part, may render the products produced under 

those conditions adulterated. 

Sec. 417.3 Corrective actions. 

(a) The written HACCP plan shall identify the corrective action to be followed in 

response to a deviation from a critical limit. The HACCP plan shall describe the 

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corrective action to be taken, and assign responsibility for taking corrective action, to 

ensure: 

(1) The cause of the deviation is identified and eliminated; 

(2) The CCP will be under control after the corrective action is taken; 

(3) Measures to prevent recurrence are established; and 

(4) No product that is injurious to health or otherwise adulterated as a result of the 

deviation enters commerce. 

(b) If a deviation not covered by a specified corrective action occurs, or if another 

unforeseen hazard arises, the establishment shall: 

(1) Segregate and hold the affected product, at least until the requirements of 

paragraphs (b)(2) and (b)(3) of this section are met; 

(2) Perform a review to determine the acceptability of the affected product for 

distribution; 

(3) Take action, when necessary, with respect to the affected product to ensure that no 

product that is injurious to health or otherwise adulterated, as a result of the deviation, 

enters commerce; 

(4) Perform or obtain reassessment by an individual trained in accordance with Sec. 

417.7 of this part, to determine whether the newly identified deviation or other 

unforeseen hazard should be incorporated into the HACCP plan. 

(c) All corrective actions taken in accordance with this section shall be documented in 

records that are subject to verification in accordance with Sec. 417.4(a)(2)(iii) and the 

recordkeeping requirements of Sec. 417.5 of this part. 

Sec. 417.4 Validation, Verification, Reassessment. 

(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. 

(1) 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, 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. 

(2) Ongoing verification activities. Ongoing verification activities include, but are not 

limited to: 

(i) The calibration of process-monitoring instruments; 

(ii) Direct observations of monitoring activities and corrective actions; and 

(iii) The review of records generated and maintained in accordance with Sec. 

417.5(a)(3) of this part. 

(3) Reassessment of the HACCP plan. (i) Every establishment shall reassess the 

adequacy of the HACCP plan at least annually and whenever any changes occur that 

could affect the hazard analysis or alter the HACCP plan. Such changes may include, but 

are not limited to, changes in: raw materials or source of raw materials; product 

formulation; slaughter or processing methods or systems; production volume; personnel; 

packaging; finished product distribution systems; or, the intended use or consumers of the 

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finished product. The reassessment shall be performed by an individual trained in 

accordance with Sec. 417.7 of this part. The HACCP plan shall be modified immediately 

whenever a reassessment reveals that the plan no longer meets the requirements of Sec. 

417.2(c) of this part. 

(ii) Each establishment must make a record of each reassessment required by paragraph 

(a)(3)(i) of this section and must document the reasons for any changes to the HACCP 

plan based on reassessment, or the reasons for not changing the HACCP plan based on 

the reassessment. For annual reassessments, if the establishment determines that no 

changes are needed to its HACCP plan, it is not required to document the basis for this 

determination. 

(b) Reassessment of the hazard analysis. Any establishment that does not have a 

HACCP plan because a hazard analysis has revealed no food safety hazards that are 

reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a 

change occurs that could reasonably affect whether a food safety hazard exists. Such 

changes may include, but are not limited to, changes in: raw materials or source of raw 

materials; product formulation; slaughter or processing methods or systems; production 

volume; packaging; finished product distribution systems; or, the intended use or 

consumers of the finished product. 

Sec. 417.5 Records. 

(a) The establishment shall maintain the following records documenting the 

establishment's HACCP plan: 

(1) The written hazard analysis prescribed in Sec. 417.2(a) of this part, including all 

supporting documentation; 

(2) The written HACCP plan, including decision-making documents associated with 

the selection and development of CCP and critical limits, and documents supporting both 

the monitoring and verification procedures selected and the frequency of those 

procedures. 

(3) Records documenting the monitoring of CCP and their critical limits, including the 

recording of actual times, temperatures, or other quantifiable values, as prescribed in the 

establishment's HACCP plan; the calibration of process-monitoring instruments; 

corrective actions, including all actions taken in response to a deviation; verification 

procedures and results; product code(s), product name or identity, or slaughter production 

lot. Each of these records shall include the date the record was made. 

(b) Each entry on a record maintained under the HACCP plan shall be made at the time 

the specific event occurs and include the date and time recorded, and shall be signed or 

initialed by the establishment employee making the entry. 

(c) Prior to shipping product, the establishment shall review the records associated 

with the production of that product, documented in accordance with this section, to 

ensure completeness, including the determination that all critical limits were met and, if 

appropriate, corrective actions were taken, including the proper disposition of product. 

Where practicable, this review shall be conducted, dated, and signed by an individual 

who did not produce the record(s), preferably by someone trained in accordance with 

Sec. 417.7 of this part, or the responsible establishment official. 

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(d) Records maintained on computers. The use of records maintained on computers is 

acceptable, provided that appropriate controls are implemented to ensure the integrity of 

the electronic data and signatures. 

(e) Record retention. (1) Establishments shall retain all records required by paragraph 

(a)(3) of this section as follows: for slaughter activities for at least one year; for 

refrigerated product, for at least one year; for frozen, preserved, or shelf-stable products, 

for at least two years. 

(2) Off-site storage of records required by paragraph (a)(3) of this section is permitted 

after six months, if such records can be retrieved and provided, on-site, within 24 hours 

of an FSIS employee's request. 

(f) Official review. All records required by this part and all plans and procedures 

required by this part shall be available for official review and copying. 

Sec. 417.6 Inadequate HACCP Systems. 

A HACCP system may be found to be inadequate if: 

(a) The HACCP plan in operation does not meet the requirements set forth in this part; 

(b) Establishment personnel are not performing tasks specified in the HACCP plan; 

(c) The establishment fails to take corrective actions, as required by Sec. 417.3 of this 

part; 

(d) HACCP records are not being maintained as required in Sec. 417.5 of this part; or 

(e) Adulterated product is produced or shipped. 

Sec. 417.7 Training. 

(a) Only an individual who has met the requirements of paragraph (b) of this section, 

but who need not be an employee of the establishment, shall be permitted to perform the 

following functions: 

(1) Development of the HACCP plan, in accordance with Sec. 417.2(b) of this part, 

which could include adapting a generic model that is appropriate for the specific product; 

and 

(2) Reassessment and modification of the HACCP plan, in accordance with Sec. 417.3 

of this part. 

(b) The individual performing the functions listed in paragraph (a) of this section shall 

have successfully completed a course of instruction in the application of the seven 

HACCP principles to meat or poultry product processing, including a segment on the 

development of a HACCP plan for a specific product and on record review. 

Sec. 417.8 Agency verification. 

FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP 

plan meets the requirements of this part and all other applicable regulations. Such 

verification may include: 

(a) Reviewing the HACCP plan; 

(b) Reviewing the CCP records; 

(c) Reviewing and determining the adequacy of corrective actions taken when a 

deviation occurs; 

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(d) Reviewing the critical limits; 

(e) Reviewing other records pertaining to the HACCP plan or system; 

(f) Direct observation or measurement at a CCP; 

(g) Sample collection and analysis to determine the product meets all safety standards; 

and 

(h) On-site observations and record review. 

PART 418—RECALLS 

Sec. 418.1 [Reserved] 

Sec. 418.2 Notification. 

Each official establishment must promptly notify the local FSIS District Office within 24 

hours of learning or determining that an adulterated or misbranded meat, meat food, 

poultry, or poultry product received by or originating from the official establishment has 

entered commerce, if the official establishment believes or has reason to believe that this 

has happened. The official establishment must inform the District Office of the type, 

amount, origin, and destination of the adulterated or misbranded product. 

Sec. 418.3 Preparation and maintenance of written recall procedures. 

Each official establishment must prepare and maintain written procedures for the recall of 

any meat, meat food, poultry, or poultry product produced and shipped by the official 

establishment. These written procedures must specify how the official establishment will 

decide whether to conduct a product recall, and how the establishment will effect the 

recall, should it decide that one is necessary. 

Sec. 418.4 Records. 

All records, including records documenting procedures required by this part, must be 

available for official review and copying. 

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