Inspection Methods 

Refresher Course 

Student Handout 

September 2021 
 

 

 

Table of Contents 

Sanitation Performance Standards .......................................................................... 3 

Sanitation Standard Performance Standards ............................................................ 9 

Hazard Analysis and Critical Control Point ............................................................. 30 

Ready-to-Eat/Shelf Stable ..................................................................................... 47 

Sampling ........................................................................................................... 84 

Labeling ............................................................................................................ 150 

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Sanitation Performance Standards (SPS) 

9 CFR 416.1- 416.6 

Purpose: 

Proper and effective sanitation is vital to every step of the food manufacturing process. This 

section will focus on helping the IPP develop a working knowledge of the Sanitation 

Performance Standards (SPS) regulations in the 9 CFR 416.1 through 416.5. IPP will learn 

how to perform the Sanitation Performance Standards Verification Task using the “GAD” 

process that is used by FSIS. The GAD process involves gathering information, assessing the 

information, and determining if the establishment complies with the regulations. IPP will also 

understand the regulatory responsibilities of IPP (9 CFR 416.6). 

Facilities that must comply with the SPS regulations: 

• Federal and State inspected meat and poultry establishments 

• Import/Export facilities 

• Identification (ID) warehouses 

• Custom-exempt operations 

Sanitation Requirements: 

• 9 CFR 416.1 - 416.5 

• FSIS Directive 5000.1 Rev. 5 addresses the Sanitation Performance Standards (SPS) 

regulations and the SPS Verification Task 

Purpose: To verify compliance with the Sanitation Performance Standards (9 CFR 416.1 -

416.5), IPP will inspect conditions in and around the official premises of the establishment, 

review documents, and inspect the facility and equipment for overall sanitary conditions. The 

establishment designates the official premises during the grant of application process. IPP 

must conduct all inspection activities within the physical boundaries designated as the official 

premises of the establishment. 

When performing the SPS task to verify SPS requirements: 

IPP should directly observe conditions in one or more areas of the establishment. IPP or the 

IIC will select standards based on the SPS noncompliance history of the establishment. When 

necessary, IPP will review the following documents: water potability certificate; pesticide use 

information; EPA registrations, labels, and instructions for proper use; sewage disposal 

approval letter (when the establishment has a private sewer system); cleaning compounds, 

sanitizing agents, processing aids, etc.; and documentation describing the safe and correct 

use of chemicals that are in the establishment. 

When performing the task, IPP should: 

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• Have a working knowledge of specific SPS regulations; 

• Ask questions specific to the regulations; 

• Directly observe areas relevant to the regulations; and 

• Assess the establishment’s answers to those questions 

How to determine compliance or noncompliance? Use professional knowledge and good 

judgement. 

• Gather information 

• Assess each situation 

• Determine if an insanitary condition has occurred. 

9 CFR 416.1 General Rules 

Sets overall requirement for the SPS, i.e., establishments must ensure operations in and 

around the establishments do not lead to insanitary conditions that would contaminate or 

adulterate product. 

9 CFR 416.1 is to be cited in situations where findings indicate that an establishment 

systematically fails to maintain sanitary conditions and that product adulteration may occur as 

a result. In fact, it is inappropriate to use in every single SPS non-compliance that will be 

documented. 

What does “insanitary” mean? A state, condition, or occurrence which may lead to the 

contamination or adulteration of edible meat or poultry product when it is exposed, processed, 

handled, stored, or packaged”. 

Sanitation Performance Standards: FSIS Directive 5000.1 -Verifying an Establishment’s 

Food Safety System 

SPS Regulations: 9 CFR Part 416.2 - 416.6: 

416.2(a) Grounds and Pest Control- The grounds about an establishment must be 

maintained to prevent conditions that could lead to insanitary conditions, adulteration of 

product, or interfere with inspection by FSIS program employees. Establishments must have in 

place a pest management program to prevent the harborage and breeding of pests on the 

grounds and within establishment facilities. Pest control substances used must be safe and 

effective under the conditions of use and not be applied or stored in a manner that will result in 

the adulteration of product or the creation of insanitary conditions. 

416.2(b) Construction 

• 416.2(b)(1) Establishment buildings, including their structures, rooms, and 

compartments must be of sound construction, be kept in good repair, and be of 

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sufficient size to allow for processing, handling, and storage of product in a manner that 

does not result in product adulteration or the creation of insanitary conditions. 

• 416.2(b)(2) Walls, floors, and ceilings within establishments must be built of durable 

materials impervious to moisture and be cleaned and sanitized as necessary to prevent 

adulteration of product or the creation of insanitary conditions. 

• 416.2(b)(3) Walls, floors, ceilings, doors, windows, and other outside openings must be 

constructed and maintained to prevent the entrance of vermin, such as flies, rats, and 

mice. 

• 416.2(b)(4) Rooms or compartments in which edible product is processed, handled, or 

stored must be separate and distinct from rooms or compartments in which inedible 

product is processed, handled, or stored, to the extent necessary to prevent product 

adulteration and the creation of insanitary conditions. 

416.2(c) Lighting- Lighting of good quality and sufficient intensity to ensure that sanitary 

conditions are maintained, and that product is not adulterated must be provided in areas where 

food is processed, handled, stored, or examined; where equipment and utensils are cleaned; 

and in handwashing areas, dressing and locker rooms, and toilets 

416.2(d) Ventilation- Ventilation adequate to control odors, vapors, and condensation to the 

extent necessary to prevent adulteration of product and the creation of insanitary conditions 

must be provided. 

416.2(e) Plumbing- Plumbing systems must be installed and maintained to: 

• 416.2(e)(1) Carry sufficient quantities of water to required locations throughout the 

establishment. 

• 416.2(e)(2) Properly convey sewage and liquid disposable waste from the 

establishment. 

• 416.2(e)(3) Prevent adulteration of product, water supplies, equipment, and utensils and 

prevent the creation of insanitary conditions throughout the establishment. 

• 416.2(e)(4) Provide adequate floor drainage in all areas where floors are subject to 

flooding-type cleaning or where normal operations release or discharge water or other 

liquid waste on the floor. 

• 416.2(e)(5) Prevent back-flow conditions in and cross-connection between piping 

systems that discharge wastewater or sewage and piping systems that carry water for 

product manufacturing. 

• 416.2(e)(6) Prevent the back up of sewer gases. 

416.2(f) Sewage- Sewage disposal -Sewage must be disposed into a sewage system 

separate from all other drainage lines or disposed of through other means sufficient to prevent 

backup of sewage into areas where product is processed, handled, or stored. When the 

sewage disposal system is a private system requiring approval by a State or local health 

authority, the establishment must furnish FSIS with the letter of approval from that authority 

upon request. 

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416.2(g) Water supply, water, ice, solution reuse 

• 416.2(g)(1) A supply of running water that complies with the National Primary Drinking 

Water regulations (40 CFR part 141), at a suitable temperature and under pressure as 

needed, must be provided in all areas where required (for processing product, for 

cleaning rooms and equipment, utensils, and packaging materials, for employee 

sanitary facilities, etc.). If an establishment uses a municipal water supply, it must make 

available to FSIS, upon request, a water report, issued under the authority of the State 

or local health agency, certifying or attesting to the potability of the water supply. If an 

establishment uses a private well for its water supply, it must make available to FSIS, 

upon request, documentation certifying the potability of the water supply that has been 

renewed at least semi-annually. 

• 416.2(g)(2) Water, ice, and solutions (such as brine, liquid smoke, or propylene glycol) 

used to chill or cook ready-to-eat product may be reused for the same purpose, 

provided that they are maintained free of pathogenic organisms and fecal coliform 

organisms and that other physical, chemical, and microbiological contamination have 

been reduced to prevent adulteration of product. 

• 416.2(g)(3) Water, ice, and solutions used to chill or wash raw product may be reused 

for the same purpose provided that measures are taken to reduce physical, chemical, 

and microbiological contamination so as to prevent contamination or adulteration of 

product. Reuse that has come into contact with raw product may not be used on readyto-eat product. 416.2(g)(4) Reconditioned water that has never contained human waste 

and that has been treated by an onsite advanced wastewater 

• treatment facility may be used on raw product, except in product formulation, and 

throughout the facility in edible and inedible production areas, provided that measures 

are taken to ensure that this water meets the criteria prescribed in paragraph (g)(1) of 

this section. Product, facilities, equipment, and utensils coming in contact with this water 

must undergo a separate final rinse with non-reconditioned water that meets the criteria 

prescribed in paragraph (g)(1) of this section. 

• 416.2(g)(5) Any water that has never contained human waste and that is free of 

pathogenic organisms may be used in edible and inedible product areas, provided it 

does not contact edible product. For example, such reuse water may be used to move 

heavy solids, to flush the bottom of open 24 evisceration troughs, or to wash 

antemortem areas, livestock pens, trucks, poultry cages, picker aprons, picking room 

floors, and similar areas within the establishment. 

• 416.2(g)(6) Water that does not meet the use conditions of paragraphs (g)(1) through 

(g)(5) of this section may not be used in areas where edible product is handled or 

prepared or in any manner that would allow it to adulterate edible product or create 

insanitary conditions. 

416.2(h) Dressing rooms, Lavatories, and Toilets: 

• 416.2(h)(1) Dressing rooms, toilet rooms, and urinals must be sufficient in number, 

ample in size, conveniently located, and maintained in a sanitary condition and in good 

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repair at all times to ensure cleanliness of all persons handling any product. They must 

be separate from the rooms and compartments in which products are processed, 

stored, or handled. 

• 416.2(h)(2) Lavatories with running hot and cold water, soap, and towels must be 

placed in or near toilet and urinal rooms and at such other places in the establishment 

as necessary to ensure cleanliness of all persons handling any product. 

• 416.2(h)(3) Refuse receptacles must be constructed and maintained in a manner that 

protects against the creation of insanitary conditions and the adulteration of product. 

416.3 Equipment & Utensils 

• 416.3(a) Equipment and utensils used for processing or otherwise handling edible 

product or ingredients 

• must be of such material and construction to facilitate thorough cleaning and to ensure 

that their use will not cause the adulteration of product during processing, handling, or 

storage. Equipment and utensils must be maintained in sanitary condition so as not to 

adulterate product. 

• 416.3(b) Equipment and utensils must not be constructed, located, or operated in a 

manner that prevents FSIS program employees from inspecting the equipment or 

utensils to determine whether they are in sanitary condition. 

• 416.3(c) Receptacles used for storing inedible material must be of such material and 

construction that their use will not result in the adulteration of any edible product or in 

the creation of insanitary conditions. Such receptacles must not be used for storing any 

edible product and must bear conspicuous and distinctive marking to identify permitted 

uses. 

416.4 Sanitary Operations: 

• 416.4(a) All food-contact surfaces, including food-contact surfaces of utensils and 

equipment, must be cleaned and sanitized as frequently as necessary to prevent the 

creation of insanitary conditions and the adulteration of product. 

NOTE: Many establishments will comply with the requirements of 416.4(a) through SSOP 

activities. 

• 416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the 

operation of the establishment must be cleaned and sanitized as frequently as 

necessary to prevent the creation of insanitary conditions and the adulteration of 

product. 

• 416.4(c) Cleaning compounds, sanitizing agents, processing aids, and other chemicals 

used by an establishment must be safe and effective under the conditions of use. Such 

chemicals must be used, handled, and stored in a manner that will not adulterate 

product or create insanitary conditions. 

Documentation substantiating the safety of a chemical's use in a food processing environment 

must be available to FSIS inspection program employees for review. 

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• 416.4(d) Product must be protected from adulteration during processing, handling, 

storage, loading, and unloading at and during transportation from official 

establishments. 

416.5 Employee Hygiene: 

• 416.5(a) Cleanliness. All persons working in contact with product, food-contact 

surfaces, and product packaging materials must adhere to hygienic practices while on 

duty to prevent adulteration of product and the creation of insanitary conditions. 

• 416.5(b) Clothing. Aprons, frocks, and other outer clothing worn by persons who 

handle product must be of material that is disposable or readily cleaned. Clean 

garments must be worn at the start of each working day and garments must be changed 

during the day as often as necessary to prevent adulteration of product and the creation 

of insanitary conditions. 

• 416.5(c) Disease control. Any person who has or appears to have an infectious 

disease, open lesion, including boils, sores, or infected wounds, or any other abnormal 

source of microbial contamination, must be excluded from any operations which could 

result in product adulteration and the creation of insanitary conditions until the condition 

is corrected. 

Custom Exempt 303.1a(2)(i) Establishments that conduct custom exempt operations must be 

maintained and operated in accordance with the provisions of §416.1 through 416.6, except for 

§416.2(g)(2) through (6) of this chapter, regarding the water reuse and any provisions of Part 

416 of this chapter relating to inspection or supervision of specified activities or other action by 

a program employee. If custom exempt operations are conducted in an official establishment, 

however, all of the provisions of 

Part 416 of this chapter shall apply to those operations. 

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Sanitation Standard Operating Procedures (SSOP) 

Objectives 

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

1. List the 4 regulatory requirements for Sanitation SOPs. 

2. State the steps taken by IPP to verify Sanitation SOP implementation and monitoring, 

maintenance, recordkeeping, and corrective actions. 

3. Identify the required corrective actions the establishment must take and record for 

noncompliances involving direct contamination or adulteration of product. 

4. List the record retention, authentication, data integrity, and daily documentation 

requirements for Sanitation SOP records. 

5. Discuss the enforcement action that could be taken when FSIS observes a noncompliance 

during a pre-operational or operational sanitation inspection. 

General Rules 

§416.11 General Rules 

Each official establishment shall develop, implement, and maintain written standard operating 

procedures for sanitation (Sanitation SOPs) in accordance with the requirements of this part. 

Sanitation Standard Operating Procedures (Sanitation SOPs) are written procedures that an 

establishment develops and implements to prevent direct contamination or adulteration of 

product. The establishment is required to maintain these written procedures on file, and they 

must be available to FSIS upon request. It is the establishment’s responsibility to implement 

the procedures as written in the Sanitation SOPs. The establishment must maintain daily 

records sufficient to document the implementation and monitoring of the Sanitation SOPs and 

any corrective action taken. When the establishment or FSIS determines that the Sanitation 

SOPs may have failed to prevent direct contamination or adulteration of product, the 

establishment must implement corrective actions that include the appropriate disposition of 

product, restore sanitary conditions, and develop measures to prevent recurrence. 

Development of Sanitation SOPs 

§416.12 Development of Sanitation SOPs 

(a) The Sanitation SOPs shall describe all procedures an official establishment will conduct 

daily, before and during operations, sufficient to prevent direct contamination or 

adulteration of product(s). 

(b) The Sanitation SOPs shall be signed and dated by the individual with overall authority onsite or a higher level official of the establishment. This signature shall signify that the 

establishment will implement the Sanitation SOPs as specified and will maintain the 

Sanitation SOPs in accordance with the requirements of this part. The Sanitation SOPs 

shall be signed and dated upon initially implementing the Sanitation SOPs and upon any 

modification to the Sanitation SOPs. 

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(c) Procedures in the Sanitation SOPs that are to be conducted prior to operations shall be 

identified as such, and shall address, at a minimum, the cleaning of food contact surfaces 

of facilities, equipment, and utensils. 

(d) The Sanitation SOPs shall specify the frequency with which each procedure in the 

Sanitation SOPs is to be conducted and identify the establishment employee(s) responsible 

for the implementation and maintenance of such procedure(s). 

Establishment Responsibilities 

The establishment has the responsibility to develop written Sanitation SOPs that clearly 

describe procedures the establishment will implement to prevent direct contamination or 

adulteration of product. The establishment and inspection personnel should understand that 

there are not separate Sanitation SOPs for different operations or different shifts. The 

Sanitation SOPs cover the entire establishment and all shifts of operation. 

These written procedures must: 

• contain all the procedures the establishment will conduct daily, before and during 

operation. 

• identify the procedures to be conducted prior to operations (pre-op) and address, at a 

minimum, the cleaning of food contact surfaces of facilities, equipment, and utensils. 

• specify the frequency with which each procedure in the Sanitation SOP is to be 

conducted and identify the establishment employee or position responsible for the 

implementation and maintenance of the procedures. 

• be signed and dated by the individual with overall authority on-site or a higher-level 

official of the establishment. This signature signifies that the establishment will 

implement the Sanitation SOPs as written and will maintain the Sanitation SOPs in 

accordance with the requirements of this part. 

Inspection Verification for the Sanitation SOP Design 

All USDA-FSIS inspected establishments must have written Sanitation SOPs that meet the 

development (basic design) requirements listed in §416.12 before a Grant of Inspection is 

given. The FLS, or designee, will ensure that new establishments have written Sanitation 

SOPs in place prior to recommending approval for a Grant of Inspection to the District Office. 

IPP will address basic design noncompliance while performing Sanitation SOP verification 

tasks. 

To effectively verify compliance with the Sanitation SOP regulations, IPP are to understand the 

Sanitation SOP regulations (§416.11 - §416.16), be familiar with the establishment’s current 

written Sanitation SOPs, and perform the verification tasks as described in FSIS Directive 

5000.1 and FSIS Directive 5000.4. 

NOTE: If IPP find that an establishment has not developed written Sanitation SOPs, they 

should contact their supervisor immediately. 

Sanitation SOP Verification Tasks 

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The following table lists four tasks used to verify compliance with Sanitation SOP 

requirements. 

Inspection Tasks General Description 

Pre-Operational Sanitation 

SOP Record Review 

Use the Recordkeeping verification activity to 

verify that the establishment implements the 

procedures in the Sanitation SOP effectively to 

prevent contamination of food contact surfaces 

or adulteration of products prior to operations. 

Pre-Operational Sanitation 

SOP Review and 

Observation 

Use the Review and Observation verification 

activity and the Recordkeeping verification 

activity to verify that the establishment 

implements the procedures in the Sanitation 

SOP effectively to prevent contamination of food 

contact surfaces or adulteration of products prior 

to operations. In PHIS, IPP should select the 

“Both” option on the Activity tab. 

Operational Sanitation 

SOP Record Review 

Use the Recordkeeping verification activity to 

verify that the establishment implements the 

procedures in the Sanitation SOP effectively to 

prevent contamination of food contact surfaces 

or adulteration of products during operations. 

Operational Sanitation 

SOP Review and 

Observation 

Use the Review and Observation verification 

activity and the Recordkeeping verification 

activity to verify that the establishment 

implements the procedures in the Sanitation 

SOP effectively to prevent contamination of food 

contact surfaces or adulteration of products 

during operations. In PHIS, IPP should select 

the “Both” option on the Activity tab. 

Regardless of which Sanitation SOP task is performed, IPP will verify that establishments meet 

all four of the following regulatory requirements in addition to the design requirements 

§416.12: 

a. Implementation and monitoring of Sanitation SOP (§416.13); 

b. Maintenance of Sanitation SOP (ensuring its effectiveness) (§416.14); 

c. Sanitation SOP corrective actions (§416.15); and 

d. Sanitation SOP recordkeeping (§416.16). 

The Record Review Tasks: Pre-Operational and Operational 

IPP use the recordkeeping verification activity to verify all four Sanitation SOP requirements 

(implementation, maintenance, corrective actions, and recordkeeping) while performing the 

Pre-Operational and Operational Sanitation SOP Record Review tasks. 

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During the Sanitation SOP record review tasks, IPP perform the following: 

1) Review the written Sanitation SOP to be familiar with the establishment’s current preoperational or operational sanitation procedures. 

2) Verify that the SSOP continues to meet the design requirements of §416.12. 

3) Verify that the establishment has maintained daily records that demonstrate that the 

establishment has implemented the pre-operational and operational procedures as 

written, monitored those procedures at least daily or at the specified frequency, and 

taken immediate or corrective action when necessary. 

For instance, IPP verify that the records indicate that the establishment conducted 

monitoring daily prior to the start of operations. If the establishment observed a 

contaminated food contact surface (residue from previous day’s product) during preoperational inspection, IPP verify that the establishment documented that the 

contaminated surface was re-cleaned, re-inspected and released before product passed 

over the surface. Similarly, if the establishment has documented the finding of 

contaminated product or food contact surfaces during operations, IPP verify that the 

documented corrective actions meet regulatory requirements. 

NOTE: In most cases, product does not contact equipment surfaces prior to the start of 

operations. However, if the establishment found contaminated product during preoperational inspection, IPP will verify that the establishment has documented corrective 

actions that meet the requirements of §416.15(b). 

4) Verify all the recordkeeping requirements of §416.16. 

For instance, IPP verify that the establishment employee responsible for the 

implementation and monitoring of the procedure has authenticated the records with their 

initials and date. 

The Review and Observation Tasks: Pre-Operational and Operational 

IPP use both the review and observation verification activity and the recordkeeping verification 

activity when performing the Pre-Operational and Operational Sanitation SOP Review and 

Observation tasks. IPP are to verify that all four Sanitation SOP requirements 

(implementation, maintenance, corrective actions, and recordkeeping). 

Each time IPP perform the review and observation tasks, they: 

1) should review the written Sanitation SOP so they are familiar with the establishment’s 

current pre-operational or operational sanitation procedures, 

2) verify that the SSOP continues to meet the requirements of §416.12, 

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3) observe the establishment conducting its monitoring activities and implementing 

corrective action when they find that the pre-operational or operational procedures have 

failed to effectively clean and sanitize food contact surfaces, 

4) inspect one or more areas and perform an organoleptic examination of some of the 

establishment’s facilities, equipment, and utensils to assess sanitary conditions 

(sometimes referred to as “hands-on” inspection), 

5) compare their findings with the establishment records/findings, (which may not be 

documented until the start of the next production day for that specific shift), and 

6) verify that the establishment meets the corrective action requirement of 9 CFR 416.15 

when they find that the establishment’s Sanitation SOP has failed to prevent product 

contamination or adulteration. 

Selecting Production Areas and Equipment for Pre-Op Sanitation SOP Review and 

Observation Verification Task (FSIS Directive 5000.4) 

In both slaughter and processing establishments, IPP follow the same methodology or thought 

process to plan their Pre-Op Sanitation SOP verification. IPP are to select the production 

area(s) and equipment to examine using a risk-based approach. The area(s) and equipment 

selected are those that present the highest risk of becoming insanitary or causing product 

contamination. 

The following factors indicate a higher risk to public health: 

1) Equipment that will contact exposed product. 

2) Equipment that will contact RTE product post-lethality. 

3) Equipment that is difficult to clean. 

4) Equipment that FSIS has not verified recently. 

5) Equipment/area(s) with a history of noncompliance; and 

6) Testing results that suggest that specific pieces of equipment may present a risk to 

public health. 

IPP review test results and other records relevant to the food safety system weekly per FSIS 

Directive 5000.2. Based on information gathered from test results, establishment sanitation 

records or other records, establishment pre-op sanitation findings, or repetitive 

noncompliances, IPP are to consider whether to increase the extent of pre-op sanitation 

verification activities (i.e., how much equipment and how many areas). 

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IPP are encouraged to discuss their thought processes for making their selections on an ongoing basis with their IIC or FLS. They are not expected to put their thought process in writing, 

nor to share it with establishment management. 

Pre-Op Sanitation SOP Review and Observation Task 

To perform the Pre-Op Sanitation SOP Review and Observation task, IPP should have: 

• A functional flashlight. 

• A pen or pencil. 

• U.S. Rejected/U.S. Retained tags and some means (tape, string, rubber bands) of 

affixing these tags to equipment, departments, product, etc. 

• A notepad to record their pre-operational findings. 

IPP not trained in lockout/tagout (FSIS Directive 4791.11) methodology shall not perform preop sanitation inspection on any piece of equipment requiring lock out. If IPP select a ready-toeat (RTE) production area for pre-operational inspection, they should start in the RTE 

department first to prevent introduction of microorganisms from the raw product areas. 

After establishment management informs IPP that an area is ready for FSIS pre-op inspection, 

IPP perform the review component of Pre-Op Sanitation SOP Review and Observation 

verification task. They are to inspect areas in the establishment, equipment and utensils, and 

places on equipment that, if insanitary, would present the greatest risk of transferring 

pathogens or other contaminants to product (e.g., direct food contact surfaces that are difficult 

to clean or may serve as microbial harborage sites). Establishments can elect to reassemble 

equipment after they complete their monitoring and implementation of the Sanitation SOPs. 

However, IPP can request that the establishment disassemble the piece of equipment so that 

the IPP will be able to perform their pre-op sanitation verification. 

IPP perform “hands-on” inspection to verify that direct food contact surfaces are 

organoleptically clean. This means that the surfaces look clean, feel clean, and smell clean. 

IPP visually examine the food contact surfaces for product residues from previous days’ 

operations. They feel the contact surfaces to determine if there are residues or foreign 

materials (e.g., grit, dust, etc.) present from previous days’ operations that are not visible. IPP 

detect any odors in these area(s) that may indicate insanitary conditions. 

If direct food contact surfaces are contaminated with residues from previous days’ operations, 

it is likely that these conditions will harbor microorganisms and/or have a chemical residue 

present. The surfaces should be free of foreign material such as fat, blood, hair, rust, dust, 

grease, and cleaning chemicals. 

IPP are to focus on food contact surfaces and not on surfaces or areas that do not directly 

contact product. They are to look at selected pieces of equipment rather than all equipment. 

When there are large numbers of simple equipment such as pans, buckets, trays, or hand 

tools, IPP are to select a representative sample (e.g., one or two each). 

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Although the focus is on food contact surfaces, IPP should remain aware of other insanitary 

conditions such as unclean non-food contact surfaces; condensation; peeling paint; and 

scaling rust from overhead fixtures in areas where products are processed, handled, or stored. 

When IPP have completed their examination of the selected area(s) and equipment, IPP 

should compare their findings to the establishment’s sanitation findings. If the written records 

are not yet completed, IPP may ask the establishment about its pre-operational findings and 

any actions taken. However, IPP must verify the recordkeeping requirements before 

completing the task. 

When IPP observe contaminated direct food contact surfaces during the pre-op sanitation 

verification, they are to reject the affected equipment. The establishment has the responsibility 

to restore sanitary conditions (clean the contaminated food contact surface) and document the 

restoration of sanitary conditions under §416.16(a). Preventive measures do not need to be 

developed and documented unless product has been contaminated or adulterated by 

the unclean surface. IPP should not remove the USDA reject tag until the establishment has 

restored sanitary conditions. 

In rare situations in which product has been contaminated or adulterated before the start of 

operations, the establishment must take corrective actions that meet the requirements in 

§416.15(b). Furthermore, IPP should not remove the regulatory control action until the 

establishment has proposed corrective actions, either verbally or in writing, that meet these 

requirements. 

In some cases, the establishment might conduct monitoring of the implementation of the 

Sanitation SOP procedures before inspection personnel arrive at the establishment. In these 

situations, the FLS or IIC will decide how frequently IPP will directly observe the establishment 

conducting their monitoring procedures. The supervisor will consider several factors when 

making this decision: 1) establishment compliance history, 2) documentation in the FSIS file, 

and 3) information from Sanitation SOP records. 

Operational Sanitation SOP Review and Observation Task 

IPP should select area(s) of the establishment and equipment that presents the highest risk 

for insanitary conditions or product contamination. If a RTE production area is selected, IPP 

should start in the RTE area to prevent introducing microorganisms from the raw product areas 

into the RTE area. 

IPP are to have: 

• a functional flashlight. 

• a pen or pencil. 

• U.S. Rejected/U.S. Retained tags and some means (tape, string, rubber bands) of 

affixing these tags to equipment, departments, product, etc. 

• a notepad to record their operational findings. 

IPP should observe the equipment, employees, and facilities to verify that product 

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contamination is not occurring during operation. For example, employees might contact 

contaminated surfaces with their hands and/or clothing and return to handling product without 

first cleaning their hands or changing their outer clothing. If IPP observe contaminated direct 

food contact surfaces or contaminated product, there is Sanitation SOP noncompliance 

whether there is a procedure written in the establishment’s Sanitation SOP to cover that 

situation or not. 

IPP should inspect direct food contact surfaces of equipment, facilities, and utensils. Although 

the task focuses on verifying product and food contact surfaces are not contaminated during 

operation, IPP should be aware of other potential sources of product contamination such as 

condensation, peeling paint, dead-end pipes, and scaling rust from overhead fixtures where 

products are processed, handled, or stored can contaminate products. 

When possible, IPP should also observe the establishment conducting its monitoring activity. 

Some establishments conduct the monitoring of operational sanitation at a frequency of once 

or twice daily. Therefore, it might be difficult for the IPP to observe this activity 

When IPP have completed their assessment of the sanitation in one or more areas of the 

establishment, they should compare their findings with the establishment’s sanitation findings. 

If the records are not complete at the time, IPP might ask the establishment if it has conducted 

monitoring and what observations were made. However, IPP must verify the recordkeeping 

requirements prior to completion of the task. 

IPP should be aware that there are times the responsible establishment employee might not 

be able to propose permanent preventive measures immediately. However, in these situations, 

the establishment should propose a tentative preventative measure of what they will do until 

they determine a permanent solution. 

Frequencies for Performing the Sanitation SOP Verification Tasks 

IPP are to perform pre-operational and operational Sanitation SOP verification tasks at 

frequencies scheduled by PHIS, or an adjusted frequency based on relevant information (e.g., 

a developing trend of noncompliance). IPP are to: 

1. perform two pre-operational Sanitation SOP verifications per week at each establishment in 

an assignment, including one Pre-Op SSOP Review and Observation and one Pre-Op SSOP 

Record Review task. These two pre-operational tasks are to be performed at an approximately 

equal amount; 

2. perform one operational Sanitation SOP verification task at each establishment in an 

assignment during each shift – either an Operational SSOP Review and Observation or 

Operational SSOP Records Review task. These two operational tasks are to be performed at 

an approximately equal amount; and 

3. perform “inspector directed” Sanitation SOP verification tasks as warranted by conditions 

observed at the establishment. For example: During the performance of other verification 

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tasks unrelated to sanitation, if inspection personnel observe insanitary conditions, they are to 

perform an Operational SSOP Review and Observation verification task. IPP are also to 

perform Sanitation SOP tasks as directed by their supervisor. 

In patrol assignments, there are times when inspection personnel cannot perform the Pre-Op 

SSOP Review and Observation task in each establishment once per week due to 

simultaneous start times or having more than five establishments on the patrol. In such cases, 

IPP are to use good judgment and their knowledge of the establishments’ compliance histories 

with sanitation requirements to decide where and when to do Pre-Op Sanitation SOP 

verification tasks. 

When an establishment operates on Saturdays, Sundays, and holidays, IPP are to conduct 

pre-operational and operational sanitation tasks in the same manner and frequency as they do 

during the week. Whenever IPP performed a task on reimbursable overtime, IPP are to check 

the appropriate box on the task’s Activity tab to document this fact. 

IMPLEMENTATION AND MONITORING 

§416.13 Implementation (Monitoring) Requirement 

a) Each official establishment shall conduct the pre-operational procedures in the 

Sanitation SOPs before the start of operations. 

b) Each official establishment shall conduct all other procedures in the Sanitation SOPs at 

the frequencies specified. 

c) Each official establishment shall monitor daily the implementation of the procedures in 

the Sanitation SOPs. 

1. Establishment Responsibilities 

The establishment is responsible for developing written procedures that are sufficient to 

prevent direct contamination or adulteration of product. The establishment also has the 

responsibility for implementing the procedures in the written Sanitation SOPs. If the 

establishment writes a procedure in its Sanitation SOP, it must implement that procedure and 

monitor it daily. In other words, the establishment is responsible for doing what it said it would 

do. 

2. Inspection Verification 

IPP should verify that the establishment is meeting these regulatory requirements by 

performing the recordkeeping, and the review and observation task. 

When verifying the implementation requirement while performing the pre-operational Sanitation 

SOP task, IPP are verifying that the establishment is meeting the regulatory requirements for 

implementation of the procedures that will be conducted before the start of operations. When 

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verifying the implementation requirement while performing the operational Sanitation SOP 

task, IPP are verifying that the establishment is implementing the procedures that will be 

conducted during operations. 

When verifying compliance with §416.13, IPP should seek answers to the following type of 

questions: 

• Is the establishment implementing the pre-operational procedures in the Sanitation SOP 

prior to the start of operations? 

• Is direct contamination or adulteration of product, or unclean direct food contact surfaces 

observed by FSIS or the establishment? 

• Is the establishment conducting the procedures in the Sanitation SOP as written? 

• Does the Sanitation SOP contain monitoring frequencies? 

• If the Sanitation SOP does not contain monitoring frequencies, is the establishment 

monitoring the implementation of the procedures in the Sanitation SOP daily? 

3. Environmental Sampling 

There are no regulatory requirements to include environmental sampling in an establishment’s 

Sanitation SOP. However, if environmental sampling is included in the Sanitation SOP, IPP 

should verify that the establishment is following those procedures. IPP should observe the 

establishment collecting samples, review sample results, and verify that the corrective actions 

specified in the Sanitation SOP are taken when necessary. The verification should be 

completed as part of the Sanitation SOP review & observation task. If the establishment is 

conducting environmental testing but the procedures are not included in the Sanitation SOP, 

IPP will review the establishment’s testing results weekly as described in FSIS Directive 

5000.2. Information gathered from such testing results should be used in the IPP’s thought 

process for selecting the areas and equipment examined and the extent of inspection (i.e., how 

much equipment and several areas) during the Operational Sanitation SOP review and 

observation task in establishments that process meat and poultry products. 

MAINTENANCE 

§416.14 Maintenance Requirement 

Each official establishment shall routinely evaluate the effectiveness of the Sanitation SOPs 

and the procedures therein in preventing direct contamination or adulteration of product(s) and 

shall revise both as necessary to keep them effective and current with respect to changes in 

facilities, equipment, utensils, operations, or personnel. 

1. Establishment Responsibilities 

Before federally inspected meat or poultry establishments are permitted to operate, they must 

develop Sanitation SOPs that prescribe sanitation measures to prevent product adulteration or 

contamination. This means establishments can only speculate about which sanitation 

measures should be included in their Sanitation SOPs to prevent the occurrence of insanitary 

conditions in their production process. The effectiveness of these measures is unknown 

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initially. Therefore, it is necessary for establishments to evaluate the effectiveness of their 

Sanitation SOPs once they are implemented. 

Each establishment must meet two primary obligations to comply with the requirements for the 

Sanitation SOP maintenance regulation. The first responsibility requires establishments to 

evaluate the effectiveness of all Sanitation SOPs that have been implemented in their 

production operations and the second requires that the establishment to revise the Sanitation 

SOP as needed to ensure that it is reflective of the operation and that the Sanitation SOP is 

effective. This regulatory requirement encourages establishments to develop a system for the 

evaluation of their written Sanitation SOPs to prevent direct contamination or adulteration of 

product. 

Although establishments must identify the members of their management team who will be 

responsible for implementation and evaluation of their Sanitation SOPs, they are not required 

to identify the method the individuals employ to perform the evaluations. The regulation only 

requires that establishments perform an evaluation of the effectiveness of their Sanitation 

SOPs; it does not dictate how establishments should perform this evaluation. The 

establishment must sign and date the Sanitation SOPs any time modifications are made. 

However, there is no regulatory requirement that the establishment personnel should notify 

FSIS inspection personnel of the change. 

It is also a responsibility of the establishments to revise their Sanitation SOPs to keep them 

effective and current with respect to changes in facilities, equipment, utensils, operations, or 

personnel. These regulations list examples of changes that may occur within an establishment 

that could alter the effectiveness of an established Sanitation SOP. However, the 

methodologies used to evaluate their Sanitation SOPs and to determine their effectiveness do 

not need to be recorded. If the establishment determines the Sanitation SOPs are no longer 

effective and current, the Sanitation SOPs must be revised. 

2. Inspection Verification 

FSIS is responsible for verifying the establishment meets the maintenance regulatory 

requirements. IPP should verify this requirement while performing the Pre-Operational and 

Operational Sanitation SOP tasks. When verifying this requirement, IPP must understand that 

IPP should review the establishment’s Sanitation SOP records and NRs over a period of time 

to determine whether this requirement is met. Just because IPP find an unclean food contact 

surface while performing the review and observation task for pre-operational sanitation does 

not mean that the establishment needs to evaluate the effectiveness of the Sanitation SOPs. 

However, if IPP look at several weeks of Sanitation SOP records, IPP might see that the 

Sanitation SOPs have repeatedly been ineffective in preventing direct contamination or 

adulteration of product. During this same period of time IPP might also find that there have 

been several NRs documenting the ineffectiveness of the Sanitation SOPs in preventing direct 

contamination or adulteration of product. IPP will have to use their professional knowledge and 

good judgment to determine whether the Sanitation SOP is meeting the maintenance 

regulatory requirement. IPP should discuss and document their concerns with the 

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establishment. If the establishment does not modify the Sanitation SOP and IPP observe 

contaminated product, IPP should take a regulatory control action. IPP might not accept 

preventive measures that do not include re-evaluation of the Sanitation SOP as an effective 

means of preventing direct contamination or adulteration of product. 

When verifying compliance with §416.14, IPP should seek answers to questions similar to the 

following: 

• Has the establishment routinely evaluated the effectiveness of the Sanitation SOPs in 

preventing direct contamination or adulteration? 

• If changes were made in the facilities, equipment, utensils, operations, or personnel, have 

the Sanitation SOPs been revised to keep them effective? 

• Does the establishment routinely review the Sanitation SOP records to determine if there 

are trends occurring indicating that the Sanitation SOP needs revising? 

NOTE: In addition to determining if the establishment has met the maintenance requirement, 

information gathered from reviewing the establishment’s Sanitation SOP records and NRs may 

be used in the thought process for selecting the areas and equipment examined and the extent 

of inspection (i.e., how much equipment and how many areas) during the Pre-Operational 

Review and Observation task in establishments that process meat and poultry products. For 

instance, IPP could determine from the Sanitation SOP records and NRs which processing 

areas or rooms and equipment are typically found to be unclean and if noncompliances are 

increasing during pre-op verification. 

Keep in mind, the establishment needs to revise the procedures as necessary to 

keep them current and effective. The Sanitation SOP may be changed frequently. The 

establishment is not obligated to notify FSIS when it revises its written Sanitation SOPs since 

FSIS does not approve the Sanitation SOP or Sanitation SOP revisions. However, the 

Sanitation SOP must be signed and dated when any modification is made. 

CORRECTIVE ACTION 

§416.15 Corrective Action Requirement 

(a) Each official establishment shall take appropriate corrective action(s) when either the 

establishment or FSIS determines that the establishment’s Sanitation SOPs or the procedures 

specified therein, or the implementation or maintenance of the Sanitation SOPs, may have 

failed to prevent direct contamination or adulteration of product(s). 

(b) Corrective actions include procedures to ensure appropriate disposition of product(s) that 

may be contaminated, restore sanitary conditions, and prevent the recurrence of direct 

contamination or adulteration of product(s), including appropriate reevaluation and modification 

of the Sanitation SOPs and the procedures specified therein or appropriate improvements in 

the execution of the Sanitation SOPs or the procedures specified therein. 

1. Establishment Responsibilities 

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These regulations require the establishment to take corrective actions when either the 

establishment OR FSIS determines the Sanitation SOPs fail to prevent direct 

contamination or adulteration of product. Regardless of the type or cause of the failure, 

corrective actions must be taken. There are three parts to corrective action and all three of 

these requirements must be met and recorded each time product contamination occurs. The 

corrective actions also include appropriate disposition of product. 

NOTE: Most of the time product will not be involved during pre-operational sanitation 

monitoring. When the establishment finds direct food contact surfaces that are unclean during 

its monitoring of pre-operational sanitation and cleans the surfaces before product passes over 

that surface, this is compliance. In these situations, FSIS believes the establishment’s 

Sanitation SOP has worked as intended. Implementing and documenting preventative 

measures are not required. 

The establishment is not required to notify inspection personnel when product contamination 

occurs but has the responsibility to implement corrective actions that will meet the 

requirements of §416.15(b). The establishment should take full responsibility for the corrective 

actions meeting the three requirements of the regulation. Those regulatory requirements are: 

• Appropriate disposition of products that may be contaminated; 

• Restoration of sanitary conditions; and 

• Prevention of recurrence of direct contamination or adulteration of products. 

Reconditioning Product 

Although there is no regulatory requirement, establishments may have a procedure in its 

Sanitation SOPs for reconditioning product that incidentally comes in contact with a non-food 

contact surface (such as the floor). The procedure usually consists of the following steps; an 

establishment employee will remove product from the floor in a timely manner, trim 

contaminants from the surface area, wash the product at a product wash station, and inspect it 

before returning it to production. This procedure is used for occasional instances of product 

contamination. If the establishment is following its written procedures and monitoring these 

procedures, the establishment would not be required to take corrective action that meets the 

requirements of §416.15 every time product falls on the floor. If the establishment does not 

have a reconditioning procedure in its Sanitation SOP, it would be required to take and 

document corrective actions that meet the requirements of §416.15 each time product falls on 

the floor. 

2. Inspection Verification 

IPP should verify this regulatory requirement when performing the Sanitation SOP verification 

tasks. Every time the establishment implements corrective actions due to product 

contamination, IPP should verify that the regulatory requirements in §416.15 are met. IPP can 

verify this requirement by performing any of the verification tasks. When performing the Pre21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operational Sanitation SOP Record Review task, IPP should request the daily pre-operational 

sanitation records that they want to review. IPP should review the monitoring records to 

determine if the establishment documented occasions in which product was contaminated. If 

there is documentation showing the establishment had found product contamination during 

pre-operational monitoring, there should also be documentation of the corrective actions taken 

for these situations. IPP should review these corrective actions and compare them to the 

regulatory requirements to verify that they have been met. Did the establishment have 

adequate documentation to demonstrate appropriate disposition of the affected product? 

Did the establishment document corrective actions that were adequate to restore sanitary 

conditions? Did the establishment document corrective actions to prevent recurrence of direct 

contamination or adulteration of product? 

When performing the Operational Sanitation SOP Record Review task, IPP should request 

from the establishment the daily operational sanitation records that they want to review. IPP 

should review the monitoring records to determine if there were instances of direct food 

contact surfaces or product being contaminated. If there is documentation showing the 

establishment had found a contaminated food contact surface that had contacted product or 

product contamination during the operational monitoring, there should also be documentation 

of the corrective actions taken for these situations. IPP should review these corrective actions 

and compare them to the regulatory requirements to verify that they have been met. Did the 

establishment have adequate documentation to demonstrate appropriate disposition of the 

affected product? Did the establishment document corrective actions that were adequate to 

restore sanitary conditions? Did the establishment document corrective actions to prevent 

recurrence of direct contamination or adulteration of product? 

When IPP are performing the Pre-Operational Sanitation SOP Review and Observation task 

and find direct food contact surfaces that are contaminated, IPP should take a regulatory 

control action on the piece or pieces of equipment. There is an insanitary condition which is 

noncompliance with §416.13(a). In most cases product is not coming into contact with 

equipment surfaces during pre-operational sanitation inspection. The establishment must clean 

the surface (re-establish sanitary conditions) and document the restoration of sanitary 

conditions according to §416.16(a). FSIS would expect the establishment to consider how to 

make appropriate improvements in the execution of its pre-operational procedures because 

the establishment must be operated and maintained in a manner sufficient to prevent the 

creation of insanitary conditions as stated in §416.1. However, establishing and documenting 

preventive measures are not required. 

If IPP are observing the establishment performing the monitoring as part of the PreOperational Sanitation SOP Review and Observation task and the monitor finds a 

contaminated food contact surface, this provides an opportunity for IPP to observe the 

establishment implementing actions to restore sanitary conditions. 

When IPP are performing the Operational Sanitation SOP Review and Observation task and 

find direct food contact surfaces or product that is contaminated, IPP should take a regulatory 

control action of that equipment or product. IPP should keep that control action in place until 

the establishment has given IPP the corrective actions and preventive measures they plan to 

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implement to restore sanitary operations and prevent recurrence. They must also implement 

corrective actions to ensure the appropriate disposition of affected product. If what they are 

proposing does not meet these regulatory requirements, the regulatory control action should 

be left in place until the establishment proposes corrective actions that will meet these 

requirements. This also provides IPP the opportunity to verify that the establishment 

implements the corrective actions that they proposed. IPP should also verify that the 

corrective actions they document are the same as those they implemented. 

If IPP are observing the establishment performing the monitoring as part of the Operational 

Sanitation SOP Review and Observation task and the monitor finds a food contact surface or 

product contaminated, this provides an opportunity for IPP to observe the establishment 

implementing the corrective actions. IPP can observe the establishment taking actions that 

restore sanitary conditions. IPP can observe the establishment to verify that they make 

appropriate disposition of product. If they put preventive measures in place immediately, IPP 

can verify these preventive measures. 

NOTE: IPP should realize that many times the establishment might not be able to propose 

preventive measures until later because decisions might involve others in the establishment. 

For example, if IPP have identified a problem and the person in that area cannot propose the 

preventive measures because of the amount of capital involved, they should inform IPP that 

they will have a meeting with top management. This should be documented on the Sanitation 

SOP records. After the meeting, when the preventive measures have been decided, the 

establishment needs to document those preventive measures in the Sanitation SOP records. 

Example: 

For example, you identify a condensation problem in an area of the establishment that is 

contaminating product. You retain the product in the area and reject that area for use. When 

you notify the responsible establishment employee of the problem, he tells you that there is a 

structural problem in that area that will cost several thousand dollars to repair. He further 

explains that he does not have the authority to have the structure repaired. He states he will 

bring it to the attention of the establishment owner and will inform you of the preventive 

measures that the owner proposes. You agree this is logical and when the appropriate 

disposition is made on the product and sanitary conditions in that area are restored, you 

relinquish the regulatory control actions. All these corrective actions should be recorded in the 

establishment records. You should keep notes of your findings while performing this 

verification task so that you can accurately document them on the NR. 

When verifying compliance with §416.15, IPP should seek answers to the following: 

• When FSIS or the establishment determines that the Sanitation SOPs fail to prevent the 

direct contamination or other adulteration of product during operation, does the 

establishment implement corrective actions that ensure appropriate disposition is made 

of any product that may be contaminated? 

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• When FSIS or the establishment determines that the Sanitation SOPs fail to prevent the 

direct contamination or other adulteration of product during operation, does the 

establishment implement corrective actions that restore sanitary conditions? 

• When FSIS or the establishment determines that the Sanitation SOPs fail to prevent the 

direct contamination or other adulteration of product during operation, does the 

establishment implement corrective actions that prevent recurrence? 

• Do the corrective actions include the reevaluation and modification of the Sanitation 

SOPs or improvements in the execution of the procedures when trends are occurring? 

NOTE: If the establishment is monitoring the pre-operational sanitation procedures, finding 

unclean food contact surfaces, and taking actions to restore sanitary conditions, and IPP are 

not finding direct food contact surfaces unacceptable, the establishment is in compliance with 

the regulations. Now, IPP should focus on whether the establishment is making improvements 

to the execution of its pre-operational sanitation procedures sufficient to prevent the creation of 

insanitary conditions and preventing direct contamination or adulteration of product. The 

requirement for preventive measures only applies when the Sanitation SOP fails to prevent 

direct contamination or adulteration of product. However, when IPP find unclean food contact 

surfaces during pre-operational sanitation inspection or direct contamination or adulteration of 

product during operations, IPP should take a regulatory control action. The regulatory control 

action should not be relinquished until the establishment has cleaned the food contact surface 

or taken corrective actions in §416.15 for contaminated product including proposing an 

acceptable preventive measure. The IPP should not accept the same preventive measures 

previously proposed by the establishment if those preventative measures were ineffective in 

preventing recurrence. 

NOTE: If the establishment finds direct contamination or adulteration of product 

and takes appropriate corrective actions as per §416.15(b), then there is no need to initiate a 

regulatory control action or document an NR. These corrective actions include restoring 

sanitary conditions, making appropriate disposition of product, and implementing measures to 

prevent recurrence. If the establishment finds a contaminated food contact surface during 

preoperational sanitation inspection and cleans and sanitizes the surface before product goes 

across that surface, then there is no need to initiate a regulatory control action or document an 

NR. 

RECORDKEEPING 

§416.16 Recordkeeping Requirement

(a) Each official establishment shall maintain daily records sufficient to document the 

implementation and monitoring of the Sanitation SOPs and any corrective actions taken. The 

establishment employee(s) specified in the Sanitation SOPs as being responsible for the 

implementation and monitoring of the procedure(s) specified in the Sanitation SOPs shall 

authenticate these records with his or her initials and the date. 

(b) Records required by this part may be maintained on computers provided the establishment 

implements appropriate controls to ensure the integrity of the electronic data. 

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(c) Records required by this part shall be maintained for at least 6 months and made available 

to FSIS. All such records shall be maintained at the official establishment for 48 hours 

following completion, after which they may be maintained off-site provided such records can be 

made available to FSIS within 24 hours of request. 

1. Establishment Responsibilities 

§416.16(a) requires the establishment to maintain daily records sufficient to document the 

implementation and monitoring of the Sanitation SOPs and any corrective actions taken. The 

establishment must have records documenting that monitoring has been conducted daily for 

each of the procedures specified in the Sanitation SOPs. If the establishment has specified a 

monitoring frequency in the Sanitation SOP that is more frequent than daily, the documentation 

would have to reflect that the monitoring activities had been conducted at the specified 

frequencies. The establishment employee specified in the Sanitation SOPs as being 

responsible for the implementation and monitoring of the procedures shall authenticate these 

records with initials or signature and the date. 

There must also be a written record of any corrective actions required by §416.15. These 

records must be maintained daily. 

Note: The establishment has until the beginning of the same shift the next business day 

to complete SSOP records. 

§416.16(b) provides the establishment the flexibility to maintain these records on a computer 

system provided the establishment implements appropriate controls to ensure the integrity of 

the electronic data. 

§416.16(c) states that the records must be kept on-site for 48 hours and must be maintained 

for at least 6 months. After the initial 48 hours, the records may be kept off-site as long as they 

can be retrieved for a program employee within 24 hours of the request. 

2. Inspection Verification 

IPP should perform the Pre-Operational Sanitation SOP Record Review task when verifying 

compliance with the pre-operational sanitation recordkeeping requirements and Operational 

Sanitation SOP Record Review task when verifying compliance with the operational sanitation 

recordkeeping requirements. IPP should verify that these daily records contain: 

• Documentation of the monitoring of the Sanitation SOPs; 

• Documentation of any corrective actions taken; and 

• Authentication (initials or signature of responsible person and the date). 

IPP should also verify that: 

• The establishment has appropriate controls to ensure the integrity of electronic data 

maintained on computers; 

• The Sanitation SOP records are accessible to FSIS; 

• The Sanitation SOP records are maintained for at least 6 months; 

• The Sanitation SOP records are maintained on-site for 48 hours after 

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Completion; and 

• The Sanitation SOP records are available to FSIS with 24 hours of request if they are 

maintained off-site. 

Some of the questions that IPP need to consider when evaluating the establishment’s records 

are listed below. As in all the other evaluations of the establishment’s Sanitation SOP system, 

IPP will need to be very familiar with exactly what the Sanitation SOP says in relation to the 

records they are keeping. In addition to knowing what is in the Sanitation SOP, IPP will also 

need to understand the regulatory aspect of recordkeeping. 

• Are the Sanitation SOP records available to FSIS upon request? 

• Are the records completed prior to the start of the same shift the next operating day? 

• Are the records completed in the manner specified in the Sanitation SOP? 

• Are the records’ entries legible? 

• Was all monitoring done and recorded at the prescribed frequency? 

• Are the records initialed or signed and dated? 

Documentation and Enforcement 

After completing a SSOP verification task, IPP are to use PHIS to document findings of 

compliance or noncompliance. 

If the establishment is in compliance with all Sanitation SOP regulatory requirements, IPP will 

mark the regulations that were verified and check the “Inspection Completed” box. 

When IPP determine that an establishment does not meet one of the regulatory requirements 

in 9 CFR §416.11 through §416.16, IPP should immediately notify the establishment’s 

management about the Sanitation SOP noncompliance and take a regulatory control action, if 

one is necessary. IPP will need to document the findings of the Sanitation SOP 

noncompliance on a Noncompliance Record (NR), FSIS Form 5400-4. 

When IPP become aware that an establishment was required to take corrective actions per 9 

CFR 416.15, IPP must verify that the establishment met the requirement and document in 

PHIS that they verified the requirements. 

When IPP observe contamination of product or direct food contact surfaces during an 

Operational Sanitation SOP verification task, they are to take a regulatory control action on the 

affected equipment or product. IPP are to remove the regulatory control action only after the 

establishment has taken corrective actions that 1) ensure appropriate disposition of products, 

and 2) restore sanitary conditions, and at least proposed 3) prevent recurrence of direct 

contamination or adulteration of products. 

When IPP observe contamination of direct food contact surfaces during a Pre-Operational 

Sanitation SOP verification task, they are to take a regulatory control action on the affected 

equipment. During pre-operational sanitation, there should be no affected product. IPP are to 

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remove the regulatory control action only after the establishment has restored sanitary 

conditions 

If the establishment has found the contaminated contact surface or product and taken the 

corrective actions required, there is no noncompliance. IPP are to verify that the establishment 

is implementing the corrective actions specified in 9 CFR 416.15 when the establishment finds 

direct contamination or adulteration of products or contact surfaces. 

When IPP observe Sanitation SOP noncompliance that does not result in contamination of 

product or food contact surfaces (e.g., failure to initial records), they are not to take a 

regulatory control action. 

If IPP observe both Sanitation SOP and SPS noncompliance while performing a Sanitation 

SOP verification task, they document both noncompliances on a single Sanitation SOP NR by 

recording a result of noncompliance for each applicable regulatory citation. 

EXAMPLE: While performing the Pre-Op Sanitation SOP Review and Observation verification 

task in the fabrication department, IPP observe product residue and grease on several meat 

hooks, in addition to fat particles and hog hair from the previous days’ production on the wall 

behind the dehairing machine. IPP are to document each noncompliance and cite §416.13(a) 

and §416.2(b) under the Pre-Op Sanitation SOP Review and Observation verification task and 

record the result on a single NR. 

If IPP observe only SPS noncompliance while performing a Pre-Op Sanitation SOP 

verification task, record the noncompliance under the task being performed at the time of the 

observation. In this example, the noncompliance would be documented under a Pre-Op 

Sanitation SOP task even though the regulatory citation is an SPS regulation. 

NOTE: If IPP determine that a Sanitation SOP noncompliance represents a systematic or 

repetitive failure by the establishment to prevent product contamination or maintain sanitary 

conditions, they are to document noncompliance with 9 CFR 416.1 in addition to the applicable 

Sanitation SOP regulation. 

Application of the Rules of Practice 

The Rules of Practice regulations describe the enforcement actions that can be taken if 

establishments do not meet regulatory requirements. Sections 500.3 and 500.4 of the Rules of 

Practice regulations describe the enforcement actions that can be imposed on an 

establishment when the Sanitation SOP regulatory requirements are not met. 

§500.3(a)(1) states that FSIS may take a withholding action or impose a suspension without 

providing the establishment prior notification if 1) The establishment produced and shipped 

adulterated or misbranded product as defined in 21 U.S.C. 453 or 21 U.S.C. 602, or 2) The 

establishment does not have Sanitation Standard Operating Procedures as specified in 

§416.11-416.12 of this chapter. 

1. Shipping contaminated or adulterated product 

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If the Sanitation SOP does not prevent contaminated or adulterated product from being 

produced and shipped, IPP should impose a withholding action as described in §500.3. 

Since contaminated or adulterated product was shipped, there is an imminent threat to the 

public health and IPP should take an immediate withholding action. When contaminated or 

adulterated product has been produced and shipped, IPP are not required to notify the 

establishment in advance that IPP are taking the withholding action. FSIS will provide the 

establishment written notification later. An NR is written documentation of the 

noncompliance. The District Office will review the circumstances and advise the FLS or IIC 

on how to proceed when further enforcement actions are necessary. 

2. Failure to meet the design regulatory requirements 

Before inspection is granted, the establishment must have developed a written Sanitation 

SOP that meets the requirements of §416.11-416.12. However, if an existing establishment 

modifies its Sanitation SOP or fails to maintain the Sanitation SOP such that it no longer 

meets the basic design requirements, IPP should notify the establishment about the 

noncompliance and contact their supervisor regarding possible enforcement specified in 

§500.3. 

Section 500.4 of the Rules of Practice states: FSIS may take a withholding action or impose a 

suspension after an establishment is provided prior notification and the opportunity to 

demonstrate or achieve compliance because: The Sanitation Standard Operating Procedures 

have not been properly implemented or maintained as specified in §§416.13 through 416.16 of 

this chapter. 

3. Repetitive Sanitation SOP failures 

This means that IPP must have adequate documentation to support the determination that 

the Sanitation SOPs have repeatedly not been implemented and maintained to be effective 

in preventing direct contamination or adulteration of product. It is not necessary for IPP to 

determine that contaminated or adulterated product has been shipped to impose the 

enforcement actions described in §500.4. It is necessary that IPP have adequate 

documentation to demonstrate that the establishment is unable to prevent repeated failures 

of the Sanitation SOPs. There are two reasons why Sanitation SOP failures can occur. (1) 

Either the Sanitation SOP is not designed adequately to prevent contamination or 

adulteration of product, or (2) the Sanitation SOPs are not properly implemented. 

IPP must associate the Sanitation SOP failures to the same cause identified within the NRs 

generated at the establishment. For this reason, accurate documentation is very important. 

Each associated NR should reference the previous NR number, the NR date, and list the 

specific preventive measures that were not implemented or were ineffective in preventing 

the recurrence of the Sanitation SOP failures. 

When IPP determine there is adequate documentation to support an enforcement action as 

specified in §500.4, IPP should contact the District Office, via supervisory channels, and 

request the assistance of an EIAO for the issuance of a Notice of Intended Enforcement 

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action (NOIE). There is no specific number of NRs required for the issuance of an NOIE, 

but their documentation should support their requested enforcement action. Based on the 

EIAO’s recommendations, the District Office will issue the Notice of Intended Enforcement 

action to the establishment. 

IPP must verify compliance and noncompliance with the SPS regulations. Noncompliance is 

the failure of an establishment to meet one or more regulatory requirements. Every time the 

IPP determines that the establishment is not meeting the SPS requirements, the IPP must 

document the noncompliance on an NR. If the IPP determines that the SPS noncompliance is 

due to the establishment’s repeated failure to maintain sanitary conditions, the IPP should 

consult with their FLS or IIC to determine if 416.1 should be added to the noncompliance 

record. When the IPP finds that any equipment, utensil, room, or compartment at an official 

establishment is insanitary or that its use could cause the adulteration of product, he or she will 

attach to it a “U.S. Rejected'' tag. Equipment, utensils, rooms, or compartments tagged cannot 

be used until made acceptable. Only an FSIS program employee may remove a “U.S. 

Rejected'' tag. 

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Hazard Analysis and Critical Control Point (HACCP) 

HACCP Seven Principles 

FSIS requires all establishments that produce federally inspected meat and poultry 

products to design and operate HACCP (Hazard Analysis and Critical Control Point) 

systems. The sevenprinciples of HACCP, which encompass a systematic approach to the 

identification, prevention, and control of food safety hazards include: 

1. Conduct a Hazard Analysis 

2. Determine Critical Control Points 

3. Establish Critical Limits 

4. Establish Monitoring Procedures 

5. Establish Corrective Actions 

6. Establish Recordkeeping and Documentation Procedures 

7. Establish Verification Procedures 

Principle 1: Conduct a Hazard Analysis. 

• A thorough hazard analysis is the key to preparing an effectively designed 

HACCPplan. 

• A hazard is a biological, chemical, or physical agent that is reasonably likely to 

occurand will cause illness or injury in the absence of its control. 

• During the development and design of the hazard analysis, establishments must 

consider all three types of hazards – biological, chemical, and physical – at each 

step they identify in the production process. Once the establishment has 

identified potential hazards, these hazards are evaluated to determine if each one 

is reasonably likely to occur (RLTO), or not reasonably likely to occur (NRLTO). 

• If the establishment determines that the hazard is reasonably likely to occur, a 

critical control point must be developed to address the hazard, either at that 

step orlater in the process. 

• If the establishment determines the hazard is not reasonably likely to occur, they 

mustprovide justification for this decision. 

• A Prerequisite Program is a procedure or set of procedures that is designed to 

providebasic environmental or operating conditions necessary for the production of 

safe, wholesome food. The programs provide a foundation for the development 

and implementation of an effective HACCP system. 

Principle 2: Determine Critical Control Points 

• A critical control point is defined as 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. 

• For each hazard that is determined to be reasonably likely to occur, the 

establishment must identify critical control points and corresponding critical limits 

that are measurable or observable. 

Principle 3: Establish Critical Limits 

• Critical limits (CL) are the parameters that indicate whether the control measure 

at theCCP is in or out of control. 

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• CL is a maximum or minimum value to which a biological, chemical, or physical 

parameter must be controlled at a CCP to prevent, eliminate, or reduce to an 

acceptablelevel the occurrence of a food safety hazard. Critical limits must be 

actual values that can be measured or quantified. 

Principle 4: Establish Monitoring Procedures 

• Monitoring is a planned sequence of observations or measurements to 

assess whether a CCP is under control and to produce an accurate record for 

future use in verification. Every CCP that is in the HACCP plan must be monitored 

to ensure that thecritical limits are consistently met and that the process is 

producing safe product. Establishments must determine how often they need to 

monitor CCPs. 

• There are three objectives to monitoring: 

o To track control of the process. This allows the establishment to identify 

trendsin the process that may be leading to loss of process control. If 

monitoring detects a trend, establishments can take appropriate 

measures to restore process control before there is a deviation from the 

critical limit; 

o To determine when the process has deviated from the critical limit. This 

information lets the establishment know that process control has been lost 

andthat appropriate corrective actions must be taken; 

o To provide a written document to be used in verification. Monitoring results 

mustbe recorded on official HACCP records, and such records serve as the 

basis forverification activities. 

Principle 5: Establish Corrective Actions 

• The corrective actions must be determined for each CCP in cases where the CL 

is notmet. 

Principle 6: Establish Recordkeeping and Documentation Procedures 

• Establishment must ensure that the HACCP system has an effective 

recordkeeping system. 

Principle 7: Establish Verification Procedures 

• HACCP systems must be systematically verified. 

HACCP 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 thehazard analysis, and 

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• HACCP records generated on an ongoing basis. 

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

HACCP Regulatory Process 

• Inspection Methodology 

oPerforming HACCP inspection tasks 

oVerifying specific HACCP regulatory requirements during the performance 

of theHACCP inspection task 

• Decision-making (GAD) 

oGathering information, making observations, reviewing documentation, 

assessing thegathered information and arriving at a supportable compliance or 

noncompliance determination. 

• Documentation 

oEntering HACCP inspection task results (observations and determinations) in PHIS 

oDocumenting noncompliance on a Noncompliance Record (NR) 

oAssociating noncompliance from the same cause 

• Enforcement 

oFollowing the Rules of Practice (ROP) 

oProviding the establishment with due process 

FSIS Responsibilities 

FSIS responsibilities for verifying an establishment food safety system are outlined in FSIS 

Directives 5000.1 and 5000.6. 

The HACCP inspection tasks appear on the establishment’s inspection Task List as 

routine tasks according to the specific HACCP process categories (listed in 9 CFR 

417.2(b)) entered in the Establishment Profile in PHIS. IPP may initiate directed HACCP 

inspection tasks when theyobserve HACCP regulatory noncompliance or are instructed to 

do so by their supervisor. 

HACCP Inspection Tasks 

IPP perform two HACCP inspection tasks to verify that establishments are complying 

with 9CFR Part 417: 

- The Hazard Analysis Verification (HAV) task directs the IPP to review the 

establishment’s hazard analysis for one HACCP plan, the HACCP plan, and any 

prerequisite programs or other documentation used to support the decision that a 

foodsafety hazard is not reasonably likely to occur in the process. 

- 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, i.e., implementation of the establishment’s 

HACCP system. IPP perform a HACCP verification task for each of the HACCP 

process categories listed inthe establishment’s profile. 

Both HACCP verification tasks can be performed as a routine or directed task. 

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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. 

Regulation 9 CFR 417.5(f) requires the establishment to make all such records 

available forofficial review. 

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. 

IPP are to assess the significance and meaning of information gathered. 

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

The Hazard Analysis Verification (HAV) Task 

The Hazard Analysis Verification (HAV) Task is a work method that provides IPP with a 

powerful approach to verifying compliance with certain requirements of 9 CFR 417, 

specificallythose that pertain to certain foundational elements of an establishment’s 

HACCP system.

These foundational elements are: 

• A flow chart and hazard analysis that matches the actual production processes 

in theestablishment; 

• A hazard analysis in which the establishment accurately considers applicable 

foodsafety hazards given the nature of the process, product, and intended 

use of the product and determines whether each hazard is reasonably likely to 

occur (RLTO); 

• Critical control points (CCPs) for hazards that are reasonably likely to occur 

in theprocess and documentation supporting those CCPs; 

• Documentation (prerequisite programs) supporting any decision that a food 

safetyhazard is not reasonably likely to occur (NRLTO) in the process; 

• Evidence supporting the validity of the HACCP system; and 

• Reassessment of the HACCP system annually and anytime changes occur that 

couldaffect the hazard analysis or HACCP plan. 

Examples of technical and scientific support the establishment can use are 

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Regulations, Pathogen Modeling Program (PMP), Processing Authority (PA), Challenge 

Studies, In-plant data, Agency compliance guidance documents, and other decisionmaking documents. 

Examples of support documents the establishment can use to support a decision that 

a hazard is not reasonably to occur are: LOG (Letters of Guarantee); COA (Certificates of 

Analysis); product temperature controls; and microbial testing programs. IPP are to review 

thesupport documents while performing the HAV task. 

Examples of Non-compliances IPP may find while performing the HAV task are: 

• The establishment’s flow chart does not accurately represent all the steps 

in theestablishment’s production process. Noncompliance with 417.2(a)(2). 

• The establishment’s flow chart does not accurately describe product 

flow.Noncompliance with 417.2(a)(2). 

• The hazard analysis identifies a hazard reasonably likely to occur (RLTO) but 

does nothave an associated CCP at or after the point where the hazard is 

introduced. Noncompliance with 417.2(c)(2). 

• The establishment does not have documentation to support the development of 

CCPs, critical limits, or monitoring and verification procedures. Noncompliance with 

417.5(a)(2). 

• The establishment does not maintain validation data. Noncompliance with 417.4(a)(1). 

• The establishment did not perform a reassessment at least once in the 

previouscalendar year. Noncompliance with 417.4(a)(3). 

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HAV Task Summary Table 

Refer to Directive 5000.6 for additional information about each 

step. 

Ste 

p 

Description Verification Questions Regs 

1 Review flow chart and 

compare to 

production process. 

• Does the flow chart represent the actual 

production process? 417.2(a)(2 

) 

Review the hazard • Does the flow chart or hazard analysis 417.2(a)(2 

analysis and identify theintended use or consumers of the ) 

consider guidance in product? 

the FSIS Meat and 

Poultry Hazards 

and Controls Guide 

(HCG). 

• Does the hazard analysis appear to consider 

the relevant food safety hazards for the 

establishment’s process, product, and intended 

use? 

• For each hazard, does the establishment 

consider it RLTO or NRLTO? 

417.2(a)(1 

) 

3 For each hazard, the 

establishment 

considers RLTO, 

verify that the HACCP 

plan includes one or 

more CCPs to control 

it. If no hazards 

are reasonably likely

tooccur, skip to step

4. 

• Does the establishment have one or more 

CCPs tocontrol the hazard in each product or 

process where it is reasonably likely to occur? 

• Does the establishment have information to 

support the CCPs, CLs, monitoring and 

verification procedures? 

417.2(c)(2 

) 

417.5(a)(2 

) 

4 For each hazard the 

establishment 

considers NRLTO, 

determine what 

evidence the 

establishment uses to 

support the decision, 

including prerequisite 

programs and other 

• Does the establishment prevent the hazard 

by implementing a prerequisite or other 

supporting program (SSOP, GMP, SOP, 

etc.)? – proceed tostep 5. 

• Does the establishment support the decision 

withother documentation besides a 

prerequisite or other supporting program? – 

proceed to step 6. 

417.5(a)(1 

) 

supporting programs 

(e.g., written 

programs, records, 

and employee 

activities). 

• Does the written program appear to be 

designed to prevent the relevant hazard? 

• Do the records and your observations 

indicate the program is consistently being 

implemented aswritten? 

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• Do the records and your observations 

indicatethat the program continues to 

prevent the relevant hazard on an 

ongoing basis? 

Step Description Verification Questions Regs 

5 Review other 

supporting 

documentation 

• Does the establishment have copies of the 

documents referenced in the hazard 

analysis? 

• Do the documents appear to apply to the 

current establishment process? 

417.5(a)(1 

) 

6 Review establishment 

validation documents, 

including scientific 

supporting documents 

and validation data. 

• Does the establishment maintain documents 

to support the scientific or technical basis for 

the CCPs and prerequisite programs used to 

support decisions in the hazard analysis? 

• Does the establishment maintain inplant validation data for the life of the 

plan? 

417.4(a)(1 

) 

7 Verify reassessment 

requirements. Check 

most recent signature 

date for each HACCP 

plan. 

• Has the establishment reassessed at least 

once in the most recent calendar year? 

• Has the establishment reassessed, if 

necessary, in response to any changes that 

could affect the hazard analysis? 

417.4(a)(3 

) 

• Has the establishment reassessed, if 

necessary, in response to any unforeseen 

hazard? 

417.3(b) 

• Has the establishment documented the 

results of the reassessment? 

417.4(a)(3 

)(ii) 

8 Document your 

findings in PHIS. 

• No problems detected – document HAV 

task results in PHIS. 

• Clear case of noncompliance – document 

HAV task results and NR in PHIS and 

notify your supervisor. 

• Concerns about the establishment HACCP 

system 

– discuss situation with your supervisor for 

assistance in determining how to 

proceed. Document HAV task results in 

PHIS. 

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HACCP Verification Task 

Introduction 

The HACCP verification task is for verifying that an establishment complies with 

the requirements of 9 CFR Part 417. There are nine HACCP verification tasks. 

Each taskrepresents a specific HACCP processing category. 

The HACCP Verification Task 

Expectations of IPP in Conducting the HACCP Verification Task 

IPP are to verify that the establishment implements its HACCP system in accordance with 

theregulations in 9 CFR Part 417 by performing the HACCP verification task. 

IPP must be familiar with the establishment’s hazard analysis, HACCP plan, and any 

prerequisite or other programs that the establishment uses to support the decision(s) that 

specific food safety hazards are not reasonably likely to occur. 

IPP use the recordkeeping and/or the review and observation components to verify that an 

establishment is effectively implementing the procedures set out in its HACCP plan. 

IPP are to verify that establishments are meeting all the HACCP regulatory requirements. 

IPP will document their findings in PHIS, including any noncompliance they find when 

performing their verification activities. 

If IPP cannot complete the HACCP verification task in one day, know the steps to take 

until thetask can be completed. 

4 Regulatory Requirements 

• Monitoring 

• Verification 

• Recordkeeping 

• Corrective Actions 

Performing the HACCP Verification Task 

1. Select a product type within the specified HACCP process category and a 

specificproduction for the selected product type. 

Specific production is a term that is used to refer to whatever method the establishment 

usesto group product, e.g., product produced during a specific period of time, a specific 

production lot, or other designated product. FSIS does not determine the method used to 

define specific production; this is an establishment’s responsibility. 

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2. Review the HACCP plan for the selected product type. 

3-5. Verify that the monitoring, verification, and recordkeeping HACCP 

regulatory requirements have been met for all CCPs in the HACCP plan 

for that specificproduction. 

6. Verify the implementation of any prerequisite programs or other programs that 

applyto the specific production. 

7. Verify that the corrective action HACCP regulatory requirement has been met. 

8. Verify that the pre-shipment review requirement for that specific production has 

beenmet. 

9. Consider any implications of noncompliance and document the HACCP 

verificationtask in PHIS. 

Regulatory Reference 

Requireme 

nt 

Regulatory References Componen 

t 

Monitoring 417.2(c)(4) Monitoring Requirement Rk 

R& 

O 

Verification 417.2(c)(7) Verification Requirement 

417.4(a)(2)(i)(ii)(iii) Verification Activities 

Rk 

R& 

O 

Recordkeepin 

g 

417.2(c)(6) Recordkeeping System Rk 

417.5(a)(3) HACCP Records Rk 

417.5(b) Records Authenticity Rk 

R& 

O 

417.5(d) Computerized Records Rk 

417.5(e)(1) and (2) Record Retention Rk 

417.5(f) Official Review Rk 

(Prerequisite Program Implementation) 

417.5(a)(1) Supporting Documentation 

Rk 

R& 

O 

417.5(c) Pre-Shipment Review Rk 

R&O (on 

occasion 

) 

Correctiv 

eAction 

417.3(a) Deviation from a critical limit 

417.3(b) Deviation not covered by a 

specifiedcorrective action/unforeseen 

Rk 

R& 

38 
hazard O 

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Monitoring 

NACMCF Monitoring Definition 

• Monitoring is a planned sequence of observations or measurements taken to 

assess whether a CCP is under control and produce an accurate record for 

future verification. 

The regulation that applies to monitoring is: 

9 CFR 417.2(c)(4)—List the procedures, and the frequency with which those procedureswill be 

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

with the critical limits. 

Methodology 

IPP may decide to use the recordkeeping component to verify the monitoring 

requirement todetermine if the establishment is performing the monitoring procedures 

at the frequency specified in the HACCP plan. 

Taking Measurements at Critical Control Points 

IPP should occasionally take measurements at certain critical control points in the process 

(i.e., perform a hands-on – review component) to verify that product meets the critical limit. 

When IPPtake measurements to verify that product meets the critical limit, they are to use 

the calibrated instrument that the establishment uses for the monitoring or verification 

activities. 

FSIS Responsibilities 

• IPP verify HACCP regulatory requirements. 

• IPP should be familiar with the monitoring procedures and frequencies in the 

currentHACCP plan. 

• Visualize what is occurring at the CCP, seek clarification. 

Observing Establishment Employees 

IPP should observe an establishment employee performing HACCP monitoring activities 

in theprocess to determine whether the procedures are being carried out as written in the 

HACCP plan. 

Verification 

Verification activities are tools that the establishment uses to ascertain that the HACCP 

plan isbeing followed correctly. 

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The regulations that apply to verification procedures and frequencies are: 

9 CFR 417.2(c)(7)—List the verification procedures, and the frequency with which those 

procedures will be performed, that the establishment will use in accordance with §417.4 

of this part. 

9 CFR 417.4(a)(2)(i)(ii)(iii)—Ongoing verification activities include, but are not limited to: 

(i) the calibration of process-monitoring instruments; (ii) direct observations of 

monitoringactivities and corrective actions; and (iii) the review of records generated and 

maintainedin accordance with §417.5(a)(3) of this part. 

Methodology 

IPP verify the verification requirement by performing the HACCP verification tasks. 

They canuse either the recordkeeping, or review and observation component, or both. 

Thought Process 

• Gathering information by asking questions 

• Assessing the information 

• Determining regulatory compliance 

Review Verification Records 

• IPP should review the verification records to determine compliance. 

• IPP should verify that it contains the actual values and observations. 

Review the HACCP Plan 

• Every HACCP Plan must contain verification procedures. 

• Establishment sets frequencies. 

• Establishments must calibrate instruments. 

Assess Information 

• Look at the establishment’s HACCP plan. 

• Review HACCP plan. 

• Review HACCP records. 

• Observe establishment employees. 

Observing Establishment Employees 

• IPP must observe establishment employees performing the verification activities 

listed inthe plan. 

• Is the establishment verifier doing activity as per the regulations? 

• Is the establishment performing verification at the infrequency set out in the 

HACCPplan? 

• Directly observe any corrective actions that need to be taken. 

Observe Product Sampling 

• Even if the product sampling is not included in the HACCP plan, we would 

41 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

reviewresults. 

Recordkeeping 

IPP verify the recordkeeping requirements when performing HACCP verification 

tasks. IPPverify recordkeeping requirements by reviewing the following: 

• The HACCP plan 

• HACCP records 

Components 

• IPP may use the recordkeeping and review and observation components. 

Thought Process 

• Gathering information by asking questions 

• Assessing the information 

• Determining regulatory compliance 

Recordkeeping System 

The regulatory requirement for a recordkeeping system is: 

9 CFR 417.2(c)(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. 

IPP verify this requirement using the recordkeeping component while performing the HACCP 

verification task. 

• Verify compliance with 417.2(c)(6). 

• Verify that HACCP Plan lists all records used to document the monitoring of 

criticalcontrol points. 

• Verify that it contains the actual values and observations. 

HACCP Records Requirement 

The regulatory requirement for HACCP records is: 

9 CFR 417.5(a)(3)—The establishment shall maintain: Records documenting the monitoring 

of CCP and their critical limits, including the recording of actual times, temperatures, or 

otherquantifiable values, as prescribed in the establishment’s HACCP plan; the calibration 

of process-monitoring instruments; correctiveactions, including allactionstaken in response 

to a deviation; verification procedures and results; product code(s), product name or 

identity, orslaughter production lot. Each of these records shall include the date the record 

was made. 

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IPP will verify compliance with this regulation by performing the HACCP verification task. 

IPPwill use the recordkeeping component to verify this regulation. 

Records Authenticity 

The regulatory requirement for record authenticity is: 

9 CFR 417.5(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. 

IPP will verify compliance with this regulation by performing the HACCP verification task. They 

are going to use the recordkeeping and the review and observation components. 

Computerized Records 

The regulatory requirement for computerized records is: 

9 CFR 417.5(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. 

IPP will verify compliance with this regulation by performing the HACCP verification task 

usingthe recordkeeping component. 

Record Retention 

The regulatory requirements for record retention and off-site storage of records are: 

9 CFR 417.5(e)(1) and (2)—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 products, 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, onsite, within 24 hours of an FSIS employee’s request. 

IPP will verify compliance with this regulation by performing the HACCP verification task 

usingthe recordkeeping component. 

Official Review Records 

The regulatory requirement for making establishment records available to IPP upon 

request forofficial review is: 

9 CFR 417.5(f) Official Review—All records required by this part and all plans 

andproceduresrequired by this part shall be available for official review and 

copying. 

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IPP will verify compliance with this regulation by performing the HACCP verification task 

usingthe recordkeeping component. 

Supporting Documentation - Prerequisite Programs and Other Supporting Programs 

The regulatory requirement that addresses the use of prerequisite programs to support 

decisions in the hazards analysis is: 

9 CFR 417.5(a)—the establishment shall maintain the following records documenting the 

establishment’s HACCP plan: (1) the written hazard analysis prescribed in §417.2(a) of this 

part, including all supporting documentation 

IPP verify this requirement using both the review and observation and the recordkeeping 

components while performing the HACCP verification task. 

If a hazard is reasonably likely to occur, must have a CCP. If the hazard is 

considered notreasonably likely to occur, a prerequisite program may be used as 

support. 

Regulatory Requirements 

• Regulatory requirement - 9 CFR 417.2(a)(2) and 9 CFR 417.5(a)(1). 

• Results of testing and monitoring activities related to the production of 

product aresubject to FSIS review. 

• Prerequisite program data and records are also reviewed during the 

ReviewEstablishment Data procedure. 

Prerequisite Programs 

• Used by establishments to support the decision in their hazard analyses that a 

particular potential hazard is not one that is reasonably likely to occur. 

NRLTO 

• There is no regulatory requirement that the prerequisite program must be written. 

• If not in writing, establishment would probably not be able to support the 

decision thehazard is not reasonably likely to occur. 

Monitoring 

• Establishments are not required to “monitor” or “verify” prerequisite programs. 

• IPP cannot cite a “monitoring” noncompliance in prerequisite program. 

• IPP do not verify compliance with specific regulatory requirements for 

monitoring, verification, and recordkeeping. 

• There are no specific regulations for monitoring activities or recordkeeping 

practices forprerequisite programs. 

Less Than Perfect 

• Less-than-perfect execution may or may not be a threat to product safety. 

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• IPP should discuss less-than-perfect implementation of supporting programs 

withestablishment management at weekly meeting. 

• The establishment’s response should be documented in the Memorandum of 

Interview (MOI). 

Corrective Actions 

Establishment must implement the corrective actions when 

1. There is a deviation from a critical limit. 

2. Unforeseen hazard has occurred. 

3. Whenever an event occurs that requires corrective action. 

IPP are to verify that the establishment implements corrective actions that meet the 

regulatory requirements. 

A deviation from a critical limit is the failure to meet the applicable value determined 

by the establishment for a CCP. If a deviation from a critical limit occurs, an 

establishment is requiredto take corrective actions in accordance with 9 CFR 417.3. 

A HACCP noncompliance is the failure to meet any of the regulatory requirements of 9 

CFRPart 417. If a HACCP noncompliance occurs, an establishment is expected to take 

immediate and further planned actions to bring itself back into compliance with 

regulations. 

9 CFR Part 417.3(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 

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 

controlafter 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. 

9 CFR 417.3(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 sectionare 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 accordancewith 

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

hazard should be incorporated into the HACCP plan. 

45 
 

 

 

 

 

 

 

 

 

 

 

 

Pre-Shipment Review Requirement 

The regulatory requirement for pre-shipment review is: 

9 CFR 417.5(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 §417.7 of this part, 

or the responsible establishment official. 

Produced and Shipped 

• Product is “produced and shipped” when the establishment completes the 

pre-shipment review, even if the product is still at the establishment. 

Methodology 

• Mostly, record keeping will be used. 

• There is a lot of flexibility in meeting this requirement. 

• No regulation addresses how the review is to be conducted or when the 

reviewmust be done. 

Regulatory Requirement 

The pre-shipment review must be signed and not just initialed. Recording the time 

when thereview performed is not a regulatory requirement. 

46 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ready-to-Eat/Shelf Stable 

Objectives 

1. Identify process steps that relate to the safety of Fully Cooked-Not SS, Heat TreatedSS, and Not Heat Treated-SS products. 

2. Identify factors requiring control at key process steps to meet standards for safety and 

product identity. 

3. State the compliance guidelines frequently used to support lethality, stabilization, and 

multiple hurdles in the establishment’s food safety systems. 

4. Explain how multiple hurdles are used in a food safety system. 

5. Describe how inspectors verify that establishments have support for their lethality, 

stabilization, and multiple hurdle food safety systems. 

6. Describe effective methods of sanitation in RTE processing environments. 

7. Describe how to verify compliance with Part 430 regulations. 

8. Identify the pathogens of concern associated with sampling of Ready-to-Eat (RTE) 

product. 

9. Describe the steps for performing a RTE sampling task. 

RTE/SS Process Familiarization 

Unit Objectives 

Define Ready-to-Eat (RTE). 

Define Shelf-Stable (SS). 

Identify process steps relating to the safety of Fully Cooked/Not Shelf-Stable (FC/NSS), Heat 

Treated/Shelf-Stable (HT/SS), and Not Heat Treated/Shelf-Stable (NHT/SS) products. 

Identify factors requiring control at key process steps to meet standards for safety and product 

identity. 

Terminology 

Ready-to-eat (RTE): A meat or poultry product that is in a form that is edible without 

additional preparation to achieve food safety and may receive additional preparation for 

palatability or aesthetic, epicurean, gastronomic, or culinary purposes. 

Not required to bear safe-handling instructions. No labeling directing that product must be 

cooked or treated for food safety. 

47 
 

 

 

 

 

 

 

 

Shelf Stable Products 

Store under ambient 

temperature and humidity 

conditions 

Microorganisms (pathogens 

and spoilage) will not grow 

throughout the 

manufacturer's specified 

shelf-life 

Every step below llr1e Is post-lethality 

,~-~---···- --· 

Optional : Post.tethallty Treatment 

'·····--·--···--· J ......... .. 

Storage, Shipping, 

Distribution 

~ 

Not Shelf Stable Products 

Refrigerate or freeze prior to 

consumption 

Microorganisms (pathogens 

and spoilage) will grow if not 

refrigerated 

Coolin -- --- Peeling 

Step where a major risk of 

contamination wilh Usterla 

monocytogenes occurs 

Rework 

Processes that can be RTE-Fully Cooked-Not Shelf Stable, Products with Secondary 

Inhibitors-Not Shelf Stable, Heat Treated-Shelf Stable, Not Heat Treated-Shelf Stable 

Products with Secondary Inhibitors-NSS-This process category applies to establishments that 

further process by using a curing processing step or a processing step using other ingredients 

that inhibit bacterial growth. These products are generally refrigerated or frozen throughout the 

product’s shelf life. Depending on the process and ingredients, these products may or may 

not meet the definition of RTE as defined in 9 CFR 430.1. 

Hotdog flow chart close-up. Lethality and post-lethality steps. 

48 
 

 

 

 

 

 

 

 

 

 

 

 

CURED HAM PROCESS 

Receiving raw hams 

[ 

C_ 

Storage (cold) 

Frozen-Refrigerated 

. Conditioning 

Thawed hams 

Boned hams 

[ Shipping ~ Finished product 

storage 

l Recelvlng addltlve5l 

St~rage 

Salting 

Post-salting 

Egualization/Burning 

~ f Drying/Ripening I L Maturation _J 

Finished product 

Packaging/1..abeling 

}

lethalitv 

Steps 

Post 

lethalitv 

Steps 

Jerky 

Jerky is cooked is cooked first, then dried. When cooking it is important to have adequate 

time, temperature, and humidity. 

After cooking, jerky is dried. Drying stabilizes the product so that spore-forming bacteria will 

not grow. Drying is important to achieve shelf-stability and to meet the product identity of jerky. 

Moisture Protein Ratio (MPR) must be ≤ 0.75:1 to meet the standard of identity for jerky.

Water activity (aw) ≤ 0.85 controls bacterial pathogen and mold growth in presence of oxygen 

If vacuum packed (no oxygen) aw ≤ 0.91 controls Staphylococcus aureus (S. aureus) growth 

and toxin production (Refrigerate after opening). 

Water activity (aw) is the important measurement for food safety, not MPR. 

Whole muscle cured products 

Lethality Steps 

Lethality steps start with salting. But Post-salting /Equalization / Burning and Drying / Ripening 

/ Maturation are steps that achieve both lethality and shelf stability 

Hams must be kept cold to prevent pathogen and spoilage organism growth while salted and 

complete coverage with salt is important. 

49 
 

 

 

 

 

 

 

 

Fermented Dry Sausage Flow Chart ~------~ ~---------~ Receiving starter 

cultures and casings 

Storage 

Preparation 

Starter 

cultures 

Receiving raw 

meat 

Storage (cold) FrozenRefrigerated 

ll!mpering frozen 

meat 

Weigh raw meat 

Receiving non-meat food 

ingredients 

Storage 

Weigh non-meat 

ingredients 

Combine ingredients and 

--+ processing 

~ Casings --~-

=========-----_________ :: ,-----------L Stufli- ng 

(chopping, grinding and/or 

mixing) 

Slicing / Peeling ~ i 

Packaging / Labeling Fermentation 

Finished product storage Heating/ Smoking Option 

Shipping Drying / Ripening 

Multiple Hurdles 

Combinatio n s o f inhibitory fac t o r s that i ndiv id ually are 

ins uffic ie nt to contro l mic roo rganis m s can ofte n b e effective. 

This h as som e times been referre d to as the multiple hurdles 

concept - if e n o u g h hurd les o r b a r r ie r s a re inc lu d ed, b acteri a 

w ill n ot b e a b le t o overcom e the hurdle s a nd gro w . 

~ ~--F_e_r_m_ e-----"". n_t_a_t_i_o_n ____ ~ 

Heating/Smoking Option Cl 

• Drying/Ripening 

• 

Fermented, Dry Sausage 

Fermentation, Optional Heating/Smoking, and Drying/Ripening steps are lethality steps and 

examples of multiple hurdle concept. 

Important to keep product cold throughout pre-fermentation steps to minimize fat-smearing 

which can slow drying. Starter culture added and is a culture of lactic acid producing bacteria 

and sugar. This starts the fermentation process. Starter culture can be added before or after 

cure, but if starter culture added after cure, thoroughly mix cure before adding as concentrated 

cure can inactivate bacteria in the starter culture. 

Lactic acid producing bacteria (LAB) consume sugar and excrete lactic acid. The pH 

decreases as the sausage environment becomes more acid which produces a tangy taste. 

Lower pH inhibits Staphylococcus aureus, which can produce enterotoxin and Micrococcus. 

pH < 5.3 Staphylococcus aureus cannot multiply or produce toxins! 

50 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The heating/smoking step is optional. If used, may add a further layer of safety to process. 

Drying- Goal is to remove moisture from the surface at the same rate as moisture migration 

from the product center (if surface dries first, will not adequately dry interior). 

Stabilization (prevention of spore-forming bacteria from growing) is accomplished through 

fermentation and drying rather than cooling quickly. 

Fermented, semi-dry sausages 

Same basic process as fermented, dry sausage production, but without the drying step. 

Fermentation and cooking used as the lethality steps. 

Non-acidified (not fermented) dry meat sticks 

Cooked first, then dried to aw <.85 (Cooking and Drying steps critical) 

Lethality, Stabilization, and Multiple Hurdles 

Unit objectives 

Define: Lethality, Stabilization, Performance Standard, and Target. 

State regulatory lethality and stabilization performance standards. 

Identify critical operational parameters in the FSIS guideline for lethality. 

Describe the relationship between humidity and cooking. 

Explain the food safety significance of drying in the jerky process. 

Explain how multiple hurdles are used in a food safety system. 

Describe how inspectors verify that establishments have support for their lethality, stabilization, 

and multiple hurdle processes. 

FSIS Directive 7111.1, Rev 2, VERIFICATION PROCEDURES FOR LETHALITY AND 

STABILIZATION, is used when verifying lethality and stabilization. 

Definitions 

Lethality is the step used to destroy pathogens, often cooking. 

Stabilization is the process used to prevent or limit the growth of spore-forming bacteria, often 

cooling. 

Multiple hurdles concept is when multiple treatments are used to achieve lethality or 

stabilization. 

Appendix A (new)-Lethality compliance guideline-non-regulatory-used for support 

Appendix B (new)- Stabilization compliance guideline-non-regulatory-used for support 

Pathogens of concern-Adulterants in RTE products 

51 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reduction Number of CFUs Log Number of Percentage 

Remaininq CFUs Remaininq Reduction 

0loq 1,000,000 106 0% 

1 loq 100,000 105 90% 

21oa 10,000 104 99% 

31oa 1,000 103 99.9% 

41oa 100 102 99.99% 

51oa 10 101 99.999% 

61oa 1 10° 99.9999% 

Any Salmonella, Listeria monocytogenes (Lm) and STEC. 

Clostridium perfringens-Spore former controlled during stabilization. With C. perfringens it is 

outgrowth to the point where toxin is produced that would cause product to be adulterated. 

Any Clostridium botulinum (C. botulinum) growth-Spore former controlled during stabilization. 

Performance standards: Quantifiable pathogen reduction levels or growth limits set by FSIS 

regulations. Performance standards are in FSIS regulations. Set by FSIS. 

Targets: Limits set by establishments to produce safe products in the absence of performance 

standards set by FSIS. Targets are not in FSIS regulations. Set by establishments. 

9 CFR 417.2(c)(2): “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.” 

Lethality Performance Standard 

Uses Salmonella as target organism. Salmonella was chosen as the pathogen of concern 

because it has been traditionally associated with certain types of RTE products. Death of 

Salmonella indicates destruction of other vegetative pathogens. No requirement to use any 

particular cooking time and temperature. For products under a performance standard, 

establishments can use a combination of treatments as long as a heat treatment is one of 

them. 

Alternative Lethality: May use treatment other than ones prescribed in regulations, provided 

support demonstrates no viable Salmonella will remain in the finished product. 

• Stabilization Performance Standard based on preventing growth of C. botulinum and C. 

perfringens. C. botulinum produces toxin in the product and causes botulism, which is 

deadly. C. perfringens is the target organism because the other spore-formers are 

slower growing. 

52 
 

 

 

 

 

 

 

 

 

 

f an establishment 

rodu ces . . . 

RTE cooke d beef 

RTE roa st beef 

RTE cooked corned 

beef 

........... 

1llan .. .,,.... w•~tr..alia.ant.. .. lanat1D.._nwl ........ m1a/l 

tallldgenlcllllcrw--- auch • 

c. ............... ll0 .... -1-log 

........-a -- a11 c. ,-11a...-pare CFR 318.17( )(2). 

N01B: Fwhllahma1la n.y bmlt . 

WlllhMrpar 8 CFR 303.2(h) ta ... ■ 

prac 111 'lhat kMI s 2-1aga uauw111 c. ,.., ...... pravlded ...... 

dcl al• wubula In m ta- --­ _,.., ol._ pramaal. (-Seclarl V D ) 

Mare bibrnlallDn baut'Wllhaa ~ be 

bnl In F8IS DIMMve 6020 1, V..ll al1 AdMlla Ix' .. U• ol 

New 

~ 

Tec:malagy In Meat aid Paulby ... Egg Praducla 

I 

Spores are like seeds. The plant (vegetative cell) is killed by cooking, but the seed (the 

spore) remains and can sprout (create a new vegetative cell) and multiply if the conditions 

for growth are right. 

Products which are warm after cooking create an ideal environment for the growth of sporeforming pathogens. It is important to cool quickly between 130° to 80° Fahrenheit. 

Some products DO have regulatory performance standards for cooking or cooling. 

Cooked Beef, Cooked Roast Beef, Cooked Corned Beef 

Lethality = 6.5-log reduction in Salmonella 

Some products are without regulatory performance standards, so targets must be established 

by establishments. 

Establishments must address hazards that are likely to occur with a CCP. 

Establishments must identify in the HACCP system: 

Lethality pathogen reduction target (e.g., 6.5-log reduction in Salmonella) 

Stabilization outgrowth controls to control Clostridium growth. 

53 
If an 

establishment 

roduces ... 

RTE uncured 

meat patties 

If an establishment 

produces ... 

Other RTE cooked meat 

products 

If an establishment 

roduces ... 

RTE shelf stable meat 

products 

stabilzation Perfannance standard 

1hen Is stabilization treatment. .. 

Is not ID allow multiplication of 

toxigenic nlic:roorganisrns such • 

C. bomllnum and no rnora than 1-

log m.-plication of C. petlifngens 

per 9 CFR 318.23(c). 

N01E: Eslabllshmenls may submit a 

waivermuaeaprocessthmmlowss: 

C. 

on 

le m c:anaid• the food mfely hmrde 

hit ar91988C1118bly likely to aa:ur m 

Ila elabilzallan praC118N8 and 

aa1abliah atepe ta pnwant. elininala, 

or Rlduoa IIDaa ham de ii> an 

aaaeplable laval (9 CFR 417 .2). 

N01E: FSIS raaomrnenda 

aa1abliahmns eat a target to s: 1-kJg 

or s: 2-laga grawlh cl C. ,.,.,fti,,,_,. In 

Iha product. To uaa a pnJCl8l8 tat 

allows s: 2-logs grawlh, 

aa1abliahmns should pn,vide 

addilianal rt Ne Saclian V.D 

ls tu CXIIIBidBr the food .rely hazard& 

that ara IH8DIIBbly likely to ooaur in Ha 

stabllzatlan pn,ceaaa and eslallllsh 

staps to pravant, allmlnata. or raduce 

thoN hmudlto .. aaaeplable level (9 

CFR417.2). 

N01E: FSIS l'IICOl1Ullllld 

Hlablilhmants allows: 1-kJg ar s: 2-loga 

growth of C. petli1nf1enB In the producl. 

To uae a pmca• that 1111cm !!I: 2-kJgs 

gn,wlh, aslablishmanta shmd provide 

addliDnal support (aaa Saclian V. D ) 

For &helf-aable praducla. 

ealabliahmants shauld limit the grawlh 

of S. BUMUS to !!I: 2-lags gl1JWlh durilll 

b, Pi w, B&pa:ially during the 

drying alep and Bl&ft no growth of 8. 

8111811S can occur d.Hin sin 

54 
If an establishment 

roduces ... 

RTE cooked poultry 

Is to achieve a 7 -log 10 

reduction of Salmonella or 

an alternative lethality to 

comply with 9 CFR 

381.150(a)(1 ). 

NOTE: The regulations 

allow establishments to set 

targets using an alternative 

lethality that ensures no 

viable Salmonella 

organisms remain in the 

finished product. FSIS 

recommends achieving ~ 5-

log reduction as an 

alternative lethality for shelfstable products. No 

additional support is needed 

to use this alternative 

lethality with shelf-stable 

products as described in 

Section V.C.2. D 

Perfonnance standard 

1hen ils stabilization 1ntatment. .. Is not to allow ndipllcation of 

toxlganic micraarganisms such • 

C. botulinum and no men Utan 1-

log11 multipllcalion of C. petfdngens 

per 9 CFR 381.150(a)(2). 

N0 1E: Eslabllshmams may submit 

a waiver to u• a process that 

allows no mora Utan 2-logs gmwlh 

of C. 

Is to consider the food safety 

hazards that Salmonella are 

reasonably likely to occur in its 

stabilization processes and 

establish steps to prevent, 

eliminate, or reduce those hazards 

to an acceptable level (9 CFR 

417.2). 

NOTE: FSIS recommends 

establishments allow S:1-log ors: 2-

logs growth of C. perfringens in the 

product. To use a process that 

allows s: 2-logs of growth, 

establishments should provide 

additional support (see Section 

V.D.). For shelf stable products, 

establishments should limit the 

growth of S. aureus to s: 2.0 logs 

during the process, especially 

during the drying step and ensure 

no growth of S. aureus can occur 

durin stora e. 

55 
 

 

 

 

If an establishment Then its lethality treatment ... 

reduces ... 

NRTE partially cooked and No lethality required, will be 

char-marked meat patties, cooked by consumer. 

and partially cooked 

poultry strips NOTE: Establishments should 

N RTE, heat treated 

not fully cooked 

products other than 

partially cooked 

and char-marked 

patties and partially 

cooked poultry 

breakfast strips 

ensure controls and preventative 

measures are in place to limit 

growth of Salmonella so that 

customary lethality processes 

(such as cooking) used by 

consumers will be adequate. 

No lethality required, will be 

cooked by the consumer. 

NOTE: Establishments 

should ensure controls and 

preventative measures are 

in place to limit growth of 

Salmonella so that 

customary lethality 

processes (such as 

cooking) used by 

consumers will be adequate 

to eliminate the food safety 

hazard. 

n.. ils stabilzation tr.anent. .. 

Must allow no nutiplcation d 

1Dxiganic microorganisms such • C. 

botulinum and no more than 1-log10 

multiplication of C. perfringens par 9 

CFR 318.23(cX1) and 9 CFR 

381.150(b). 

N01E: Eslablishrnanta may submit a 

waiver 1D use a slabilizalion procaas 

that allows~ 2-logs growlh of C. 

perfringens and no multiplication of C. 

botulinum. 

Is to consider the food safety 

hazards that are reasonably likely 

to occur in it stabilization processes 

and establish steps to prevent, 

eliminate, or reduce those hazards 

to an acceptable level (9 CFR 

417.2). 

NOTE: FSIS recommends 

establishments allow s 1-log or s 2-

logs growth of C. perfringens in the 

product. To use a process that 

allows s 2-logs of growth, 

establishments should provide 

additional support (see Section 

V.D.). Establishments should also 

limit the growth of S. aureus to s 2-

logs during the process. 

RTE and Cooked Product Validation Compliance 

Establishments must decide how to design their process to control hazards. Establishments 

may use FSIS guidelines, published processes, or develop customized processes. Whichever 

support they chose, establishments must implement all critical operational parameters into 

their process. 

Important: all critical operational parameters match the process and are implemented. 

Must be validated!! 

Process must be validated, it must be based on scientific literature and supported by data 

showing the process can be implemented as designed in the establishment. 

56 
 

 

 

 

 

 

 

 

 

FSIS Compliance Guidelines-Provide guidance and information to industry. 

Not regulatory - not mandatory. Establishments are not required to use the compliance 

guidelines to support their critical limits or parameters – they may have other support. May be 

used to support the selection of CCPs and critical limits in the HACCP plan, or critical 

operational parameters in a prerequisite program. 

List of Important FSIS Compliance Guidelines 

Lethality Guideline - Appendix A 

Stabilization Guidelines- Appendix B 

Lebanon Bologna Compliance Guidelines 

Jerky Compliance Guidelines 

Lethality Guidelines-Appendix A- The new guideline, (still called Appendix A) incorporates the 

old Appendix A and includes the Time-Temperature Tables for Cooking poultry, & 5-log table, 

that used to be separate guidelines. 

If the FSIS Lethality Guideline, known as Appendix A, is used as supporting documentation for 

the selection of CCPs and critical limits, all the conditions listed must be addressed. 

Three critical operating parameters must be met! 

Time 

Temperature 

Humidity 

Contains time and temperature combinations for cooked beef that achieve the required 6.5-log 

reduction in Salmonella. 

Temperatures are internal product temperatures. 

57 
 

 

 

 

 

Appendix A Compliance Guidelines for Meeting Lethality Performance Standards for 

certain Meat and Poultry Products (Appendix A) 

Meat products can be prepared using one of the following time and temperature combinations. 

The stated temperature is the minimum that must be achieved and maintained in all parts of 

each piece of meat for a least the stated time. Establishments should apply humidity when 

using this table or additional support should be provided for the process. 

Degrees

Fahrenheit Degrees

Centigrade 

6.5-log 10 lethality 7-log10 lethality 

130 54.4 112 min. 121 min. 

131 55.0 89 min. 97 min. 

132 55.6 71 min. 77 min. 

133 56.1 56 min. 62 min. 

134 56.7 45 min. 47 min. 

135 57.2 36 min. 37 min. 

136 57.8 28 min. 32 min. 

137 58.4 23 min. 24 min. 

138 58.9 18 min. 19 min. 

139 59.5 15 min. 15 min. 

140 60.0 12 min. 12 min. 

141 60.6 9 min. 10 min. 

142 61.1 8 min. 8 min. 

143 61.7 6 min. 6 min. 

144 62.2 5 min. 5 min. 

145 62.8 4 min. 4 min. 

146 63.3 169 sec. 182 sec. 

147 63.9 134 sec. 144 sec. 

148 64.4 107 sec. 115 sec. 

149 65.0 85 sec. 91 sec. 

150 65.6 67 sec. 72 sec. 

151 66.1 54 sec. 58 sec. 

152 66.7 43 sec. 46 sec. 

153 67.2 34 sec. 37 sec. 

154 67.8 27 sec. 29 sec. 

155 68.3 22 sec. 23 sec. 

156 68.9 17 sec. 19 sec. 

157 69.4 14 sec. 15 sec. 

158 70.0 0 sec.** 0 sec.** 

159 70.6 0 sec.** 0 sec.** 

160 71.1 0 sec.** 0 sec.** 

58 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

** The required lethalities are achieved instantly when the internal temperature of a cooked 

meat product reaches 1580 F or above.

Other processes may also use Appendix A 

Appendix A can be used to support critical limits for cooking or heat treatment CCPs for other 

RTE meat, including pork. Establishments that produce other types of RTE meat may use 

Appendix A to support their critical limits, times and temperatures, applied at the cooking or 

heat treatment CCPs in their HACCP plans. 

In addition to time and temperature, humidity is another critical heating factor in Appendix 

A, which is often overlooked. The time and temperature combinations are based on moist 

(wet) heat! 

Humidity is a critical parameter for lethality of pathogens, especially Salmonella. If not 

maintained product surface will not heat as quickly, product surfaces can dry out, and bacteria 

become more heat resistant. 

Options for maintaining relative humidity in Appendix A include, for meat and poultry products 

of any size, when the cooking time is at least 1 hour, and process temperature is above 145°F 

Option 1-Introducing steam for 50% of the cooking time but not less than 1 hour. 

Option 2-Sealing oven for 50% of the cooking time but not less than 1 hour. 

Option 3-Introducing steam to achieve humidity at 90% for at least 25% of the cooking time or 

1 hour. 

When Humidity Controls are Not Needed 

Some processes inherently maintain required humidity. Immersing the product in the liquid 

cooling medium, cooking product in sealed, impervious bag, applying direct heat, using an 

impermeable or semi-permeable product casing. 

Other processes, like direct heat-grilling, flames in direct contact, heating coil, get lethal effect 

before the surface dries out. This is usually the case for patties. 

The humidity recommendations in Appendix A apply to heat processes that can evaporate 

moisture from the surface of the product and surface drying can occur before the destruction of 

the pathogens. 

Humidity is NOT needed for large roasts, products that are 10 pounds or more, cooked at 250 

or higher, because they have a low surface to mass ratio, the surface dries slower and 

Salmonella is less likely to become heat resistant. 

Options if the cooking temperature is below 145° F 

Option 4-At least 90% Relative Humidity for at least 25% of the cooking time, or 1 hour, 

whichever is longer. 

59 
 

 

 

 

 

 

 

 

 

 

Fahrenheit Degrees Centigrade 1'1⁄4 fat l '1⁄4 fat 3'1⁄4fat 4'1⁄4 fat 5'1⁄4fat 6'1⁄4fat 796 fat B'1⁄4fat 9'1⁄4 fat 10'1⁄4 fat 1196 fat 11'1⁄4fat 

136 57.8 63.3 min 64.5 min 65.7min 67 min 68.4 min 69.9 min 71.4 min 73 min 74.8min 76.7 min 78.9 min 81.4 min 

137 58.3 50.1 min 51 min 52.1 min 53.2 min 54.3 min 55.5 min 56.8 min 58.2 min 59.7 min 61.4 min 63.3 min 65.5 min 

138 58.9 39.7 min 40.5 min 41.3 min 42.2 min 43.2 min 44.2min 45.3 min 46.4min 47.7min 49.2min 50.9 min 52.9 min 

139 59.4 31.6 min 32.2 min 32.9 min 33.6 min 34.4 min 35.2 min 36.2 min 37.2 min 38.3 min 39.6 min 41.1 min 43min 

140 60.0 25.2 min 25.7 min 26.2min 26.8 min 27.5 min 28.2 min 29 min 29.8 min 30.8 min 32min 33.4 min 35 min 

141 60.6 20.1 min 20.5 min 21 min 21.5 min 22 min 22.6 min 23.2 min 24min 24.9 min 25.9 min 27.1 min 28.7 min 

142 61.1 16.1 min 16.4 min 16.8 min 17.2 min 17.6 min 18.1 min 18.7 min 19.4 min 20.1 min 21 min 22.1 min 23.5 min 

143 61.7 13 min 13.2 min 13.5 min 13.8 min 14.2 min 14.6 min 15.1 min 15.6 min 16.3 min 17.1 min 18.1 min 19.3 min 

144 62.2 10.4 min 10.6 min 10.8min 11.1 min 11.4 min 11.8 min 12.2 min 12.6 min 13.2 min 13.9 min 14.8 min 15.9 min 

145 62.8 8.4 min 8.6 min 8.7min 8.9 min 9.2 min 9.5 min 9.8min 10.2 min 10.7 min 11.3 min 12.1 min 13min 

146 63.3 6.8 min 6.9 min 7min 7.2 min 7.4 min 7.6min 7.9 min 8.2min 8.6 min 9.1 min 9.8min 10.6 min 

147 63.9 5.5 min 5.5 min 5.6min 5.7 min 5.9 min 6.1 min 6.3 min 6.6min 6.9 min 7.4min 7.9 min 8.6min 

148 64.4 4.4 min 4.4 min 4.5min 4.5 min 4.7 min 4.8min 5min 5.2min 5.Smin 5.8min 6.3min 6.8min 

149 65.0 3.5 min 3.5 min 3.5min 3.6 min 3.6 min 3.8min 3.9 min 4.lmin 4.3min 4.6min 4.9min 5.4min 

150 65.6 2.7 min 2.7 min 2.7min 2.7 min 2.8 min 2.9 min 3min 3.lmln 3.3 min 3.5 min 3.8min 4.2min 

151 66.1 2.1 min 2 min 2mln 2.1 min 2.1 min 2.lmln 2.2mln 2.3 min 2.5mln 2.6mln 2.9 min 3.1 min 

152 66.7 1.5 min 1.5 min 1.5min 1.6 min 1.6 min 1.6min 1.7mln 1.7mln 1.8mln 1.9 min 2.1 min 2.3 min 

153 67.2 1.2 min 1.2 min 1.2min 1.2 min 1.3 min 1.3 min 1.3 min 1.3 min 1.4min 1.4min 1.4min 1.6min 

154 67.8 55.9 sec 56.9 sec 58 sec 59.1 sec 1 min lmin lmin 1.1 min 1.lmin 1.1 min 1.1 min 1.1 min 

155 68.3 44.2 sec 45 sec 45.9 sec 46.8 sec 47.7 sec 48.6 sec 49.5 sec 50.4sec 51.4 sec 52.4sec 53.4 sec 54.4sec 

156 68.9 35 sec 35.6 sec 36.3 sec 37 sec 37.7 sec 38.4 sec 39.2 sec 39.9 sec 40.7sec 41.4sec 42.2 sec 43 sec 

157 69.4 27.7sec 28.2 sec 28.7 sec 29.3 sec 29.8 sec 30.4 sec 31 sec 31.6 sec 32.2 sec 32.8 sec 33.4sec 34sec 

158 70.0 21.9 sec 22.3 sec 22.7 sec 23.2 sec 23.6 sec 24 sec 24.5 sec 25 sec 25.4 sec 25.9 sec 26.4 sec 26.9 sec 

159 70.6 17.3 sec 17.6 sec 18 sec 18.3 sec 18.7 sec 19 sec 19.4 sec 19.8 sec 20.1 sec 20.5 sec 20.9 sec 21.3 sec 

160 71.1 13.7 sec 14 sec 14.2 sec 14.5 sec 14.8 sec 15 sec 15.3 sec 15.6 sec 15.9 sec 16.2 sec 16.5 sec 16.9 sec 

161 71.7 10.8 sec 11 sec 11.2 sec 11.5 sec 11.7 sec 11.9 sec 12.1 sec 12.4 sec 12.6 sec 12.8 sec 13.1 sec 13.3 sec 

162 72.2 <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec 9.6 sec 9.8 sec 10 sec 10.2 sec 10.3 sec 10.5 sec 

163 72.8 <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec 

164 73.3 <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec 

165 73.9 <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec 

Option 5-At least 90% RH for the entire cooking time. 

Note: For any time/temperature combination, if your products’ total cooking time is less than 1 

hour, maintain Relative Humidity. 

Time-Temperature Tables for Cooking RTE Poultry 

Contains time and temperature recommendations for chicken and turkey to achieve a 7.0-log10 

reduction in Salmonella. Establishments should consider the use of humidity 

The Poultry Time-Temperature Tables, included in the lethality compliance guidelines, provide 

establishments with time and temperature combinations that can be used to cook chicken and 

turkey products with 1 to 12% fat levels. 

Time-Temperature Tables for Cooking Ready-to-Eat Poultry Products (Poultry Time-Temperature Tables) 

Times for given temperature and fat level for Chicken needed to obtain 7-log lethality of Salmonella* 

* The required lethalities are achieved instantly at the internal temperature in which the holding 

time is < 10 seconds. Establishments should apply humidity when using this table or 

additional support should be provided for the process. 

60 
 

 

 

Fahrenheit Degrees Centigrade 1%f at Z% f at 3%fat 4%f at 5%f at 6%fat 7%fat 8%fat 9%f at 10%fat 11%f at 11%fat 

136 57.8 64min 64.3 min 64.6min 64.9 min 65.3 min 65.8 min 66.3 min 66.9 min 67.6 min 68.4 min 69.5 min 70.8min 

137 58.3 51.9 min 52.2 min 52.4min 52.8min 53.2 min 53.6 min 54.1 min 54.7min 55.3 min 56.2 min 57.2 min 58.5 min 

138 58.9 42.2 min 42.5 min 42.7min 43 min 43.4 min 43.8 min 44.2min 44.8min 45.4 min 46.2 min 47.2 min 48.5min 

139 59.4 34.4 min 34.6 min 34.9 min 35.1 min 35.4 min 35.8 min 36.2min 36.7 min 37.3 min 38.1 min 39.1 min 40.4min 

140 60.0 28.1 min 28.3 min 28.5 min 28.7min 29min 29.3 min 29.7min 30.2min 30.8 min 31.5 min 32.5 min 33.7min 

141 60.6 23 min 23.2 min 23.3 min 23.5 min 23.8 min 24.l min 24.4min 24.9 min 25.5 min 26.2 min 27.1 min 28.2min 

142 61.1 18.9 min 19 min 19.1 min 19.3 min 19.5 min 19.8 min 20.1 min 20.5 min 21.1 min 21.7min 22.6min 23.7min 

143 61.7 15.5 min 15.6 min 15.7min 15.9 min 16.1 min 16.3 min 16.6min 17min 17.4 min 18 min 18.8min 19.8min 

144 62.2 12.8 min 12.8 min 12.9 min 13 min 13.2 min 13.4 min 13.7mln 14min 14.4 min 15min 15.7mln 16.6mln 

145 62.8 10.5 min 10.6 min 10.6min 10.7 min 10.8 min llmin 11.3 min 11.5 min 11.9mln 12.4 min 13 min 13.8min 

146 63.3 8.7 min 8.7mln 8.7mln 8.8mln 8.9 min 9mln 9.2min 9.5 min 9.8mln 10.2 min 10.8mln 11.5 min 

147 63.9 7.lmln 7.lmln 7.1 min 7.2mln 7.3 min 7.4mln 7.5mln 7.7mln 8mln 8.4min 8.8 mln 9.4 min 

148 64.4 5.8mln 5.8mln 5.8mln 5.8mln 5.9 min 6mln 6.lmln 6.3 min 6.5 min 6.8mln 7.2mln 7.7mln 

149 65.0 4.7mln 4.7min 4.7mln 4.7mln 4.7mln 4.8min 4.9mln 5min 5.2mln 5.4min 5.8min 6.2mln 

150 65.6 3.8mln 3.7mln 3.7mln 3.7mln 3.7mln 3.8mln 3.9mln 4mln 4.lmln 4.3 min 4.5mln 4.9 min 

151 66.1 3 min 2.9min 2.9 min 2.9 min 2.9 min 2.9min 3 min 3.1 min 3.2min 3.3 min 3.5 min 3.8mln 

152 66.7 2.3 min 2.3 min 2.3 min 2.3 min 2.3 min 2.3 min 2.3min 2.3 min 2.4min 2.5mln 2.7mln 2.8min 

153 67.2 1.8 min 1.8mln 1.9 min 1.9 min 1.9 min 1.9 min 1.9mln 1.9 min 1.9 min 1.9 min 1.9 min 2.1 min 

154 67.8 1.5min 1.5min 1.5 min 1.5 min 1.5 min 1.5min 1.5min 1.5 min 1.5 min 1.6min 1.6min 1.6min 

155 68.3 1.2min 1.2min 1.2mln 1.2mln 1.2 min 1.2min 1.2min 1.3 min 1.3 min 1.3 min 1.3 min 1.3 min 

156 68.9 59 sec 59.3 sec 59.5 sec 59.8 sec 1 min lmin lmin lmin 1 min lmin lmin lmin 

157 69.4 47.9 sec 48.1 sec 48.3 sec 48.5 sec 48.8 sec 49 sec 49.2 sec 49.5 sec 49.7 sec 49.9 sec 50.2 sec 50.4 sec 

158 70.0 38.8 sec 39 sec 39.2 sec 39.4 sec 39.6 sec 39.8 sec 40sec 40.1 sec 40.3 sec 40.5 sec 40.7 sec 40.9 sec 

159 70.6 31.5 sec 31. 7 sec 31.8 sec 32 sec 32.1 sec 32.3 sec 32.4 sec 32.6 sec 32.7 sec 32.9 sec 33 sec 33.2 sec 

160 71.1 25.6 sec 25. 7 sec 25.8 sec 26 sec 26.1 sec 26.2 sec 26.3 sec 26.4 sec 26.6 sec 26. 7 sec 26.8 sec 26.9 sec 

161 71.7 20.8 sec 20.9 sec 21sec 21.1 sec 21.2 sec 21.3sec 21.4 sec 21.5 sec 21.6 sec 21.7 sec 21.8 sec 21.9 sec 

162 72.2 16.9 sec 16.9 sec 17 sec 17.1 sec 17.2 sec 17.3 sec 17.3 sec 17.4 sec 17.5 sec 17.6 sec 17. 7 sec 17.7 sec 

163 72.8 13.7 sec 13. 7 sec 13.8 sec 13.9 sec 13.9 sec 14sec 14.1 sec 14.1 sec 14.2 sec 14.3 sec 14.3 sec 14.4 sec 

164 73.3 11.1 sec 11.2 sec 11.2 sec 11.3 sec 11.3 sec 11.4 sec 11.4 sec 11.5 sec 11.5 sec 11.6 sec 11.6 sec 11.7 sec 

165 73.9 <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec <10.0 sec 

Times for given temperature and fat level of Turkey needed to obtain 7-log lethality of Salmonella* 

*The required lethalities are achieved instantly at the internal temperature in which the holding time is < 10 

seconds. Establishments should apply humidity when using this table or additional support should be 

provided for the process. 

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Appendix "B" Stabilization (Cooling) 

Appendix B provides guidance for processors that cook meat and poultry products to meet FSIS's 

stabilization (cooling) performance standard. 

FSIS provided proven time and temperature requirements in Appendix B for establishments to use to 

meet the required stabilization performance standard without having to do extensive research to support 

their process. 

Appendix B is a guideline. However, if followed precisely, Appendix B is a validated process schedule 

because the guideline contains processing methods already accepted by the Agency as effective in 

safely cooling cooked meat and poultry products. 

Remember that FSIS performance standard is less than 1.0 log growth of C. perfringens. All four of the 

Appendix B cooling options, if incorporated into the establishments HACCP system, will support that 

standard. 

Rapid cooling between 130°F and 80°F is extremely important. Data has shown that 80°F is the 

approximate transition between rapid growth and slower growth of many food-borne pathogenic 

bacteria, including C. perfringens and C. botulinum. 

If the establishment cannot rapidly cool the product in accordance with the one of the cooling options in 

the guideline, it can develop custom stabilization (cooling) procedures provided they met the 

performance standard when the product they produce is subject to 9 CFR 318.17, 318.23 and 

381.150. Of course, this would require the establishment to have documentation other than Appendix B 

to support its cooling data. The supporting documentation could be a challenge study or inoculated test 

pack study performed by a processing authority. 

Option 1 (≤ 1.0 log10): During cooling, the product’s maximum internal temperature should not remain 

between 130°F to 80°F for more than 1.5 hours nor between 80°F and 40°F for more than 5 hours (6.5 

hours total cooling time). This option applies to: 

• Fully cooked products (including intact or non-intact meat or poultry) and 

• Partially cooked, small-mass products provided the establishment can support the heating come-up 

time (CUT) to the final heating temperature for partially cooked small mass products is ≤ 1 hour.

• Products may be cured or uncured although there is a larger safety margin if cured. 

Appendix B- Option 2 

Start chilling product within 90 minutes of the end of cooking 

Cool product temperature from: 

o 120°F to 80°F in 1 hour 

o 80°F to 55°F in 5 hours 

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Continue chilling until 40°F 

Fully cooked, cured, and uncured processes may use this option 

Appendix B-Cured Products-Option 3 

Fully Cooked cured product must have at least 100 ppm of ingoing sodium nitrite and 250 ppm 

erythorbate or ascorbate. 

Cool the product temperature from: 

o 130°F to 80°F in 5 hours 

o 80°F to 45°F in 10 hours 

Natural sources of nitrite and ascorbate may be used per FSIS Directive 7120.1. 

Option 4 (≤ 1.0 log10): The following process may be used for the slow cooling of fully cooked meat 

and poultry products cured with nitrite or salt. During cooling, the product’s maximum internal 

temperature should not remain between 120°F to 40°F for more than 20 hours and the cooling 

process: 

• causes a continuous drop in product temperature; or 

• controls the product’s temperature so that it does not stay between 120°F and 80°F for more 

than 2 hours 

This option applies to: 

• Fully cooked products (including intact or non-intact meat or poultry) 

• Formulated with ≥ 40 ppm of sodium nitrite or its equivalent and a brine concentration of 6% or 

more; or 

• Formulated with or without nitrite (such as salt cured product), but with a maximum water 

activity of 0.92. 

Lethality & Stabilization for Jerky Products 

Jerky- Lethality Treatment 

Meat cooking (lethality) process should achieve at least 5.0-log reduction of both Salmonella 

and shiga-toxin-producing E. coli (STEC). 

Poultry process should achieve at least 5.0 log reduction of Salmonella 

The drying (stabilization) step results in reduced water activity to prevent the outgrowth of pathogens 

such as S. aureus and C. perfringens. 

aw or Water Activity is used for food safety-≤.85 in aerobic environment. ≤.91 if vacuum packaged 

(anaerobic environment). 

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Fish Shellfish 

Tree Nuts Peanuts Wheat Soybeans 

Multiple Hurdle Concept 

Combinations of inhibitory factors that individually are insufficient to control microorganisms 

can often be effective. This has sometimes been referred to as the multiple hurdles concept – 

if enough hurdles or barriers are included, bacteria will not be able to overcome the hurdles 

and grow. 

FSIS recommends lethality of 5.0-log10 reduction of Salmonella and 5.0-log10 reduction of STEC for 

products containing beef. 

FSIS expects establishments to include the lethality pathogen reduction targets, and stabilization log 

outgrowth controls for C. perfringens and C. botulinum, in its HACCP plan or supporting documentation. 

For most shelf-stable products, the pH (≤ 4.6) or water activity (0.93) preclude the growth of the 

primary hazards of concern (i.e., Clostridium perfringens and Clostridium botulinum). 

Food Ingredients of Public Health Concern 

Unit Objectives 

1. List the “Big 8” food allergens. 

2. Distinguish between a food allergy and food intolerance. 

3. Describe establishment responsibilities for controlling ingredients of public health concern. 

4. Identify situations that could lead to cross contact with a food allergen. 

5. Identify situations that may result in mislabeling of a product containing an ingredient of 

public health concern. 

6. Distinguish between labeling requirements for ingredients of public health concern and 

voluntary labeling declarations. 

7. Explain when an establishment can include factual statements about a product's processing 

environment on the product label. 

8. Describe how to perform and document the "Big 8" Formulation Verification task. 

Definitions: 

A food allergy is a specific type of adverse immune system reaction to a particular food or food 

ingredient which can be life threatening. 

“Big 8” Allergens make up 90% of all 

allergic reactions to foods. 

Food intolerances are non-allergic 

sensitivities to some food or color additives 

which produce gas, bloating, and digestive 

upsets, but are rarely life threatening. 

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Allergies Food Intolerances 

• • o An al lergic reaction is potentially • o A non-allergic sensitivity to some • 

life threatening. • food or color additive . • • o Trace amounts of an al lergen could • o Usually not life-threatening . • trigger a severe reaction. • • o Can still have public health • o Consumers must rely on accurate • significance . • product labeling. • 

Food intolerances to lactose, sulfites, FD&C No. 5-FD&C (Yellow) No. 5 or tartrazine, Monosodium 

glutamate (MSG), gluten, and nitrates/nitrites are common. 

Establishment Responsibilities 

In the Hazard Analysis, establishments determine if any ingredients used in product formulation are of 

public health concern and consider the controls necessary to prevent cross contact and assure accurate 

labeling. These can be included in the establishment’s HACCP plan, SSOPs, or other prerequisite 

program. 

Cross contact may result from: 

Inadequate control of ingredients 

Inappropriate use of ingredients 

Inadequate implementation of sanitation procedures 

Inaccurate Labeling 

Inaccurate labeling of properly formulated product is also a threat to consumers sensitive to any 

ingredients. 

Ingredients of public health concern must be declared in the ingredients statement. 

Voluntary statements on labels alert consumers to the presence of specific ingredients but are not 

required. Examples include: “Contains wheat”, "Contains milk", "Contains sodium caseinate (from 

milk)". 

Statements About Processing Environment may only be used when GMPs and Sanitation SOPs cannot 

reasonably be expected to eliminate possibility of cross - contact. Not a substitute for good sanitation. 

Example: "Produced in a plant that uses peanuts." 

Big Eight Allergen Formulation Verification task-FSIS Directive 7230.1, Rev 2 

A method used to verify that establishments accurately control and label the “Big 8” allergens. Applies to 

all HACCP processing categories EXCEPT slaughter. 

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All Establishment Products 

Priority 1: Have one or more of 

the products had a change in 

supplier of ingredient s, a 

change in ingredients, or a 

change in formul ation within 

the past six months? 

Priority 2: Do one or more of the 

products incorporate a multiingredient component 

produced outside the 

establishment? 

• If only one product had a 

change, use this product for 

verification; 

• If multiple products have 

had a change, use the 

product produced in the 

largest volume. 

• If only one product 

incorporates such a 

component, use this 

product for verification; 

• If multiple products 

incorporate such 

components, use the 

product produced in the . . . 

If the prioritization does not result in a single product, IPP are to choose the product 

produced in the l argest volume. IPP are to avoid selecting the same product for 

consecu1ive verification tasks as described in section VII. D. and E. 

NOTE: Examples of multi-ingredient components include sauces, condiments such as ketchup or 

mustard, seasoning packets, flavorings, spice mixes, soup bases, or other combinations of two or more 

ingredients that are mixed together (in this case, outside of the establishment). 

Ready to Eat SS Sanitation 

Unit Objectives 

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

1. Identify why establishments producing RTE products have a special responsibility for adequate 

sanitation in the RTE processing environment. 

2. Describe effective methods of sanitation in RTE processing environments. 

3. Identify potential sanitation issues in RTE processing environments. 

Terminology 

Lethality Treatment-A process, including the application of an antimicrobial agent, that eliminates or 

reduces the number of pathogenic microorganisms on or in a product throughout the shelf life of the 

product. 

Post-Lethality Exposure involves the handling of RTE product that comes into direct contact with a 

food contact surface after it has been subjected to an initial lethality treatment. 

Cross-contamination is the transfer of bacteria to exposed RTE product after the lethality treatment. 

Listeria monocytogenes (Lm) is of particular concern because it has potentially fatal consequences. 

Listeriosis can lead to septicemia, meningitis, and spontaneous abortion. It is especially pathogenic to 

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high-risk populations, including pregnant women, newborns, elderly, and people with weakened immune 

systems. Spread by direct food contact with contaminated surfaces. Grows in cool, damp 

environments. Gets nutrients from product debris. Can make biofilms to protect itself (a biofilm is a 

thin, slimy film of bacteria that adheres to a surface, effectively protecting it from the environment). It is 

hardy; can survive and grow in packaged refrigerated product, resists salt, nitrite, and acid. Illnesses 

and deaths linked to products adulterated with Lm. Adulteration of product occurs through crosscontamination from environmental sources after cooking (or other lethality steps). 

Verification Sampling 

Definitions: 

Environmental surfaces-These are areas where product does not make contact like walls, 

ceilings, floors, underneath tables - carts, employee shoes, electrical cables/switches/outlets, etc... 

Food Contact Surfaces - These are surfaces that have direct contact with product, such as tabletops, 

hands, gloves, aprons, knives, packaging material/film, conveyor belts, brine (when product is not in a 

cook-in-the-bag), etc... 

Product - These are samples of the actual product after it has gone thru the lethality step. The amount 

and number of samples will depend on the type of product, testing procedure and amount represented. 

Cleaning is the removal of product residue from the equipment and environment. 

Sanitizing is the application of either heat or chemicals to substantially reduce the numbers of 

microorganisms to an acceptable level. 

Pre-operational Sanitation General Steps 

Rotating Detergents & Sanitizers helps maintain effectiveness by keeping bacteria "off balance". 

Control air/product/employee traffic flow so they do not bring Lm and other adulterants into the RTE 

environment. 

Lm and Construction 

Lm has been linked to disruptive construction. Lm is in the environment. Dust/debris generated can 

carry Lm all over the equipment and facilities, if not controlled. Dust carried by the air currents and/or 

employees could bring Lm and other adulterants to 

the RTE environment. 

Disruptive construction includes removal of drains, 

floors, and walls, movement of materials, exposure 

of areas not typically cleaned. Establishments are 

responsible for controlling food safety issues 

resulting from construction. 

Testing for Listeria 

monocytogenes vs. Listeria spp. 

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Listeria monocytogenes (Lm) = pathogen 

Listeria species (spp.) = indicator organism 

The term Listeria spp. (spp. = species) refers to all strains of Listeria. Because Lm may be present only 

in very low numbers, it can be difficult to detect with the available testing capabilities. Therefore, many 

establishments use a testing plan for Listeria spp. because it is easier and faster to find Listeria spp. 

since the method is testing for more than one species of Listeria. Positive test results for Listeria spp. 

should be viewed as an indication that Lm may be present and alert the establishment that there are 

possibly insanitary conditions in the facility. Finding Lm is direct evidence of a pathogen and the 

product contacting any contaminated food contact surfaces would be considered adulterated. 

Positive test of product with Listeria spp. means product MAY be adulterated. Positive test of product 

with Listeria monocytogenes means product IS adulterated. 

Listeria monocytogenes Regulations 

Unit Objectives 

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

1. Identify reasons Listeria monocytogenes (Lm) is a public health threat for ready-to eat (RTE) meat 

and poultry products. 

2. Verify compliance with the regulations in 9 CFR 430 by following instructions in FSIS Directive 

10,240.4 “Verification Procedures for Consumer Safety Inspectors for the Listeria monocytogenes 

Regulation and Lm Sampling Programs.” 

L. monocytogenes is a major foodborne pathogen of significant potential public health concern. Lm is 

widespread in the environment and can be found in soil, on plant materials, in animal feedstuffs, and the 

intestinal tracts of various mammals and birds. It tolerates a variety of environmental conditions and 

can reproduce at temperatures just below freezing or as high as 113°F, water activity as low as 0.92, 

and pH ranging from 4.39 to 9.4. Pregnant women and their fetuses, young children, the elderly, and 

immune-comprised individuals are most susceptible to illness. 

For these reasons, FSIS considers Lm a hazard which must be controlled by establishments that 

produce post-lethality exposed RTE products. Public health strategies for protecting consumers 

against Lm include specific regulatory requirements (9 CFR Part 430) intended to control Lm in areas 

where RTE products are post-lethality exposed. 

9 CFR 430.1 Definitions 

Ready-to-Eat (RTE) Product – edible meat or poultry product that does not require any additional 

preparation by the consumer to achieve food safety. 

Deli Product – RTE meat or poultry product that is typically sliced either in an official establishment or 

after distribution and assembled in a sandwich for consumption. NOTE: USDA regulates closed-face 

sandwiches and FDA has jurisdiction over open-faced sandwiches. 

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Hotdog Product – RTE meat or poultry frank, frankfurter, wiener, or other product that complies with a 

standard of identity as defined in 9 CFR 319.180 and 319.181. 

Lethality Treatment – a process an establishment uses to eliminate or reduce the number of 

pathogenic microorganisms on or in a product for that product to be safe for human consumption. 

Antimicrobial Agent – a substance in or added to RTE product that will suppress or inhibit Lm growth 

in the product throughout the entire shelf life of that product. 

Antimicrobial Process – an operation (e.g., freezing, fermentation) applied to RTE product that 

suppresses or limits Lm growth in the product throughout the entire shelf life of that product. 

Prerequisite Program (PRP) – a procedure or set of procedures designed to provide the basic 

environmental or operating conditions necessary for the production of safe, wholesome food. 

Indicator Organism – a type of bacteria (often Listeria spp. in RTE establishments) used to determine 

when objectionable microbial conditions occur either in food or processing, production areas, or storage 

rooms. The presence of these microorganisms means pathogens may be present in the product or the 

processing environment. 

Additional terms: 

Post-lethality Treatment (PLT) – additional lethality treatment following the initial lethality process that 

is applied to either post-lethality exposed final product or the sealed product package to reduce or 

eliminate Lm contamination in the post-lethality environment. 

Post-lethality Processing Environment – an area in an establishment where product that has been 

subjected to an initial lethality treatment is conveyed for further processing or packaging. 

Post-lethality Exposed (PLE) Product – RTE product that comes into direct contact with an FCS in a 

post-lethality processing environment after the lethality treatment has been applied. 

Lm Regulation 430: 

Applies to RTE product exposed to the environment following the lethality process. 

Not ready-to-eat (NRTE) product and product not post-lethality exposed is NOT subject to Lm regulation 

9 CFR 430.4. 

The fully cooked not shelf stable HACCP processing category applies to establishments that further 

process products by using a lethality treatment that includes a cooking step. “Lethality” is a process that 

reduces or eliminates pathogenic microorganisms to achieve food safety. An effective lethality process 

should reach at least a 7-log reduction for Salmonella in cooked poultry products, a 6.5 log reduction for 

cooked meat products, and at 5 log reduction in other products with adequate support. FCNSS 

products meet the RTE definition but are not shelf stable and must be kept frozen or refrigerated to 

maintain food safety. Certain RTE products (e.g., fully cooked sausages, barbecued meats, roast 

beef) are required by a standard of identity to be fully cooked. 

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Some establishments may produce fully cooked products (casserole, meat balls, etc.) that have no 

standard of identity requirement or customary or usual identity and choose to label it as NRTE (Not 

Ready-to-Eat). 

Classify these under Heat-Treated-Not Fully Cooked-Not Shelf Stable (HT-NFC-NSS). 

Verifying 9 CFR 430 Compliance 

Verify RTE processing alternative selected. 

Verification results demonstrate effectiveness of establishment control measures and made available 

upon request. 

Verify establishment compliance with chosen alternative through appropriate SSOP or HACCP tasks in 

PHIS. 

Listeria Regulation 9 CFR 430 

Intended to further reduce incidence of Lm in post-lethality exposed RTE meat and poultry products. 

Includes 3 alternatives establishments use to control Lm. 

Establishments required to maintain sanitary conditions. 

Contact DO if establishment subject to Part 430 fails to meet requirements. 

Listeria Control Alternative 1 

9 CFR 430.4(b)(1) Alternative 1: 

Post-lethality treatment (may also be antimicrobial agent or process) 

Reduces or eliminates Lm on product 

-ANDAntimicrobial agent or process 

Suppresses or limits Lm growth throughout product shelf life AND 

Sanitation 

Alternative 1 requires use of a post-lethality treatment (i.e., an antimicrobial agent or process) to reduce 

or eliminate (kills) Lm on the product and an antimicrobial agent or process that suppresses or 

limits Lm growth. The word AND is key here!!! Antimicrobial Agent is abbreviated AMA. Antimicrobial 

Process is abbreviated AMP. 

70 
 

 

 

 

 

 

 

 

 

 

 

lncreasina Ris 

A LTERNATIVE 1 

Post-lethality T reatment 

AND Antimicrobial 

Agent o r Process 

Requirements 

V a lidate effectiveness of post-lethality treatment (PL T). Must be included as X 

a CCP in the establishment's HACCP Plan and should show at least a 1-log 

reduction in Lm prio r to d istribution of the product int o comm erce 

Document effectiveness of antimicrobia l agent or process: Must be included X 

a s part of the establishment's HACCP, Sanitation SOP, or Prerequisite 

Program and should demonstrate no more than 2-logs growth of Lm over the 

estimated shelf life. 

Sanitation Program Requirements 

Testing food contact surfaces (FCS) in the post-lethality process ing 

env ironment for Lm or an indicator oraanism. 

State testing frequency. 

Identify size and location of s ites to be sampled. 

Expla in why testing frequency is sufficient to control Lm or an indicator 

o rganism. 

Identify conditions for Hold-and-Test, w hen FCS (+ ) for Lm or a n indicator 

onianism. 

Addit ional Sanitation Program Requirements 

Follow-up testing to verify corrective actions are effective after 1• FCS (+ ) 

for Lm or an indicator organism. Includes testing of targeted FCS as most 

likely source and additional testing o f the surrounding area. 

If follow-up testing yields 2"° FCS (+ ), hold products that may be 

contaminated until problem is corrected as shown by FCS (-) in follow-up 

testina. 

Hold and test product lots using a sampling plan that provides statistical 

confidence that the lots are not contaminated w ith Lm or an indicator 

o rganism. Release, rework, or condemn products based on results. 

Docu ment results and prod uct disposition. 

Establishments in a ll three a lternatives must maintain sanitation in X 

accordance with 9 C F R 416. 

Alternative 1: Post-lethality treatment and anti-microbial agent/process verification questions: 

Is the post-lethality treatment incorporated in the HACCP plan? Must be a CCP. 

Does the establishment have validation data for the post-lethality treatment in accordance with 9 CFR 

417.4 and 430.4(b)(1)(ii)? Must be validated. 

Is the establishment implementing the post-lethality treatment as described in the HACCP plan? 

Are they conducting monitoring, verification, meeting recordkeeping requirements, and taking HACCP 

corrective actions when required? 

Alternative 1: Post-lethality treatment and anti-microbial agent/process: 

Has the establishment incorporated the use of the anti-microbial agent or process to suppress or limit 

the growth of L. monocytogenes in its HACCP plan, its Sanitation SOPs, or a pre-requisite program? 

Some AMAs or AMPs may also act as a PLT if they reduce or eliminate the pathogen AND control its 

growth over the shelf life of the product. An example of an AMP that also acts as a PLT is a process 

such as drying or fermenting, which renders an RTE product shelf stable. 

71 
 

 

 

 

 

 

 

 

 

 

 

 

1 

Listeria monocytogenes (L.m.) 

I 

Control 

I 

Post-Lethality a Anti-Microbial 

Treatment Agent/Process 

Of Product That Suppresses/Limits Growth 

! ! 

L.m. is a Hazard l May Not Reduce L.m. 

"Reasonablv Ukelv to Occur' But it is Still Effective Through 

! Limiting 

The Outgrowth of Organisms that 

MUST be Included in HACCP Plan Survive the Post-Lethality Process 

With Point of Treatment as CCP 

(9 CFR 417.1) ! ! ! 

! SSOP 0 Pre- 0 Validated 

Validated as Effective in (9 CFR 416) Requisite HACCP Plan 

Reducing/Eliminating Lm. Program (9 CFR 417) 

(9 CFR 417.4) I I I 

! 

I Records Must Be Made Available to FSIS Upon Request 

Note: 

If an Anti-Microbial Agent/Process is Applied as Part of the Can Serve as both 

Initial Lethality Step AND Still Has a Continuing Bactericidal 

-- Post-Lethality Treatment -, Establishment Must Have Supporting Documentation On I Effect on L.m That Persists Through Post-Lethality AND File 

Exposure/Distribution Growth-Inhibitor 

FSIS Directive 10,240.4 includes that IPP are to be aware that the Listeria Guideline recommends that 

the PLT will be validated to achieve at least a 1-log reduction of Lm before the product leaves the 

establishment. Furthermore, it states that IPP are to be aware that the Listeria Guideline recommends 

that the AMAP will allow no more than 2-log outgrowth of Lm over the shelf life of the product. 

Food contact surface or product testing for Lm or Listeria ssp. is not required for Alternative 1. FSIS 

recommends FCS testing at least 2 times/year/line (every 6 months). 

If you find that the establishment has not met all regulatory requirements (you answered “no” to one or 

more of the GAD questions), there is noncompliance. 

You should issue an NR, and reference 9 CFR 430.4(b)(2) and, depending on where the use of the 

antimicrobial agent or process is addressed, either the appropriate section of 417 (for HACCP and 

prerequisite programs) or the appropriate section of 416 (Sanitation SOP). 

Listeria Control Alternative 2 

9 CFR 430.4(b)(2): Alternative 2 

Alternative 2 Options 

Alternative 2, Choice 1 or Choice 2 

Choice 1 – Post-lethality treatment 

72 
 

 

 

 

 

 

 

 

 

 

 

 

2 

Post-lethality Treatment OR 

Antimicrobial Agent or 

Requirements Process 

Choice 1 Choice 2 

Post-lethality Antimicrobial 

Treatment to Agent or 

reduce or Process to 

eliminate Lm suppress or 

+' on product limit qrowth 

Validate effectiveness of post-lethality treatment (PL T). Must be included as a CCP in the 

establishment's HACCP Plan and should show at least a 1-log reduction in Lm prior to 

distribution of the product into commerce X 

Document effectiveness of antimicrobial agent or process: Must be included as part of the esta..Jishment's 

HACCP, Sanitation SOP, or Prerequisite Program and should demonstrate no more than 2-logs growth of Lm 

over the estimated shelf life. X 

Sanitation Proqram Reauirements X 

Testing food contact surfaces (FCS) in the post-lethality processing environment for Lm or an indicator 

orqanism. X 

State testing frequencv. X 

ldentifv size and location of sites to be sampled. X 

Explain why testinq frequency is sufficient to control Lm or an indicator orqanism. X 

ldentifv conditions for Hold-and-Test when FCS /+\ for Lm or an indicator oraanism. X 

Additional Sanitation Pro11ram Requirements 

Follow-up testing to verify corrective actions are effective after 1st FCS (+) for Lm or an indicator organism. 

Includes testinq of tarqeted FCS as most likely source and additional testinq of the surroundinq area. 

If follow-up testing yields 2nd FCS (+), hold products that may be contaminated until problem is corrected as 

shown by FCS (-) in follow-up testinq. 

Hold and test product lots using a sampling plan that provides statistical confidence that the lots are not 

contaminated with Lm or an indicator organism. Release, rework, or condemn products based on results. Document 

results and product disposition. 

Establishments in all three alternatives must maintain sanitation in accordance with 9 CFR 416. X X 

-ORChoice 2 – Antimicrobial agent or process + Sanitation, including FCS testing 

Under Choice 1, the establishment selects to use a post-lethality treatment that reduces or 

eliminates Lm on the product. As with Alternative 1, the effectiveness of the post-lethality treatment 

must be validated. 

For Choice 2, the establishment uses an antimicrobial agent or process that suppresses or 

limits Lm growth. 

When no post lethality treatment is used (Alternative 2, Choice 2), the establishment relies more on 

sanitary practices and must verify sanitation effectiveness with a sampling program. 

Listeria Control Testing Requirements 

The establishment must identify: 

- Target organism (either Lm or an indicator organism). 

- Size and location of Food Contact Surface (FCS) test sites. 

- Frequency of testing. 

- Support for the testing frequency selected. 

- Conditions to hold-and-test product for positive sample results. 

73 
 

 

 

 

 

 

 

 

 

 

 

2 

Listeria monocytogenes (L.m.) 

I 

Control 

Post-Lethality A a Anti-Microbial Sanitation Program A Treatment Agent/Process N That MUST: 

Of Product That Suppresses/Limits Growth D 

! ! 

Lm. is a Hazard r ' . Provide testing of food contact "Reasonablv Ukelv to Occur' surfaces 

! May Not Reduce L.m. . Identify hold and test for 

MUST be Included in HACCP Plan But it is Still Effective Through positive 

With Point of Treatment as CCP Limiting finding of L.m. or indicator 

(9 CFR 417.1) The Outgrowth of Organisms that organism 

Survive the Post-Lethality Process . State frequency of testing 

! . Identify size/location of sampling 

Validated as Effective in '- sites 

Reducing/Eliminating L.m. 

(9 CFR 417.4) ! ! 

SSOP 0 Pr_e- 0 Validated 

(9CFR416) Requisite HACCP Plan 

Program (9 CFR 417) 

I 

J. 

Records Must Be Made Available to FSIS Upon Request l 

Non-food contact surfaces such as walls, floors, drains, refrigeration units, etc. may be tested for 

indicator organisms, aerobic plate count (APC), or total plate count (TPC) in addition to FCS testing, 

but these results cannot be used to indicate the presence/absence of Lm in lieu of FCS testing. 

Alternative 2 Choice 1 Verification Questions 

Is the post-lethality treatment (which may be an antimicrobial agent) incorporated in the HACCP plan? 

It must be a CCP. 

Does the establishment have validation data for the post-lethality treatment in accordance with 9 CFR 

417.4? It must be validated. 

Is the establishment implementing the post-lethality treatment as described in the HACCP plan? 

Monitoring, Verification, Corrective Actions, Recordkeeping requirements met? 

Alternative 2 Choice 2 Verification Questions 

Has the establishment incorporated the use of the antimicrobial agent or process to suppress or limit the 

growth of L. monocytogenes in its HACCP plan, its Sanitation SOPs, or a prerequisite program? 

To select Choice 2, the establishment MUST utilize an antimicrobial agent or process to limit the growth 

of Lm in the product during the shelf-life of the product. 

Is the establishment using the antimicrobial agent or process as described in its HACCP plan, its 

Sanitation SOPs, or a prerequisite program? 

74 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

You verify that the establishment is using the antimicrobial agent or process in accordance with HACCP 

regulatory requirements while performing the appropriate HACCP verification task if the establishment 

has incorporated the use of the agent or process into the HACCP plan. 

Alternative 2 Choice 2: How does the establishment demonstrate that the sanitation procedures are 

preventing Lm from being in the post-lethality processing environment? It uses a microbial sampling 

program. 

Provide for testing of food contact surfaces in the post-lethality processing environment to ensure that 

the surfaces are sanitary and free of L. monocytogenes or of an indicator organism? 

The establishment must test FCSs for either Lm or an indicator organism. It may test non-food contact 

surfaces such as walls, floors, drains, refrigeration units, etc., for indicator organisms or conduct 

aerobic plate count (APC) or total plate count (TPC) tests but these results cannot be used to indicate 

the presence/absence of Lm in the post-lethality processing environment in place of testing FCSs 

for Lm or an indicator organism!!! 

Does the establishment's testing for verifying the on-going effectiveness of their sanitation procedures: 

- State the frequency with which testing will be done? 

- Identify the size and location of the sites that will be sampled? 

- Include an explanation of why the testing frequency is sufficient to ensure that effective 

control of L. monocytogenes, or an indicator organism, is maintained? 

-Identify the conditions under which the establishment will implement Hold & Test procedures 

following a positive test of an FCS for Lm or an indicator organism? 

The establishment must identify what conditions trigger implementation of hold-and-test procedures, 

e.g., the first positive result for Lm, the first positive result for an indicator organism, 2 consecutive 

positive results for an indicator organism, etc. 

For establishments producing RTE products under Alternatives 1 and 2, there is no magic number; 

rather, the establishment is free to select at what point hold and test procedures will be 

initiated, provided it can be supported. here is a suggested sampling frequency table in 

the Listeria guidelines. Some establishments will use those guidelines for the frequency of testing and 

cite them as support. 

In determining the size, for a FCS, the establishment should take into account that the FCS on any 

piece of equipment will vary. For this reason, the establishment’s written program must state the 

size and location of the sites that will be sampled. For example, for equipment with FCS less than 1 

sq. ft., the entire surface should be sampled. For FCS larger than 1 sq. ft., a contiguous area of at least 

that size should be sampled. 

Samples taken after 3 hours of the start of production would provide the most efficient time to detect 

contamination with Lm or an indicator organism. 

9 CFR 430.4(b)(3): Alternative 3-Sanitation Measures Only 

75 
 

 

 

 

 

 

 

3 

Listeria monocytogenes (L.m.) 

Control 

Sanitation Program 

That MUST: 

For RTE Products: For Hotdog & Deli-Type Products: 

• 

• 

• 

• 

• 

Provide testing of food contact 

surfaces 

Identify hold and test for 

positive 

finding of L.m. or indicator 

organism 

State frequency of testing 

Identify size/location of 

sampling sites 

Support testing frequency 

• 

• 

• 

Verify corrective actions after 

initial positive sample of food 

contact surface 

Test and hold in the case of a 

second positive 

Sample and test lots to release 

OR rework to destroy L.m. 

Records Must Be Made Available to FSIS Upon Request 

Sanitation only 

Lm or indicator organism FCS testing 

Sampling frequency based on establishment size or volume (large, small, very small) and whether or 

not the establishment produces deli meats and hotdogs. 

RTE products processed under Alternative 3 are considered to be higher risk because the 

establishment is not applying either a post-lethality treatment or an antimicrobial agent or process. For 

this reason, the establishment must test FCS in post lethality environments to ensure they are sanitary 

and free of Lm or indicator organisms. The frequency, size, and location of FCS sites tested, support 

for the frequency, conditions for hold-and-test for positive samples must be identified. 

Alternative 3 Verification Questions 

Does the establishment have on-going verification testing procedures designed to: 

Have sanitation measures incorporated in its HACCP, Sanitation SOP, or other prerequisite program? 

76 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

l 

Test food contact surfaces in the post-lethality processing environment to ensure that the surfaces are 

sanitary and free of L. monocytogenes or of an indicator organism? 

Identify the conditions under which the establishment will implement hold-and-test procedures following 

a positive test of a food-contact surface for L. monocytogenes or an indicator organism? 

Does the establishment have on-going verification testing procedures designed to: 

o State the frequency with which testing will be done? 

o Identify the size and location of the sites that will be sampled? 

o Include an explanation of why the testing frequency is sufficient to ensure that effective control 

of L. monocytogenes, or an indicator organism, is maintained? 

The establishment MUST document the rational thought process it used in determining the frequency of 

FCS testing and why that frequency will ensure effective control of Lm or an indicator 

organism. Evidence such as scientific articles or prior history could be used. If you have an issue with 

the adequacy of the establishment’s explanation, you should contact your FLS. 

The frequency for testing FCS for Lm or an indicator organism is expected to be greater in 

establishments that produce deli and hot dog type RTE products under Alternative 3. 

Remember there is a suggested sampling frequency table in the Listeria guidelines. Some 

establishments will use those guidelines for the frequency of testing and cite them as support. 

Table 3.1 Minimum Routine Sampling Frequencies for Testing of Food Contact Surfaces (FCS) for 

Alternative 3. 

Alternative Daily Product Volume Range Food Contact Surface (FCS) Testing 

** 

Minimum Frequency* 

Alternative 3 

Non-deli, non- hotdogs 

1 time/month/line (monthly) 

Alternative 3 

Deli, hotdogs HACCP Size: 

Very Small 

Small 

Large 

1-6,000 1 time/month/line (monthly) 

6,001 – 50,000 2 times/month/line 

(every 2 weeks) 

50,001->600,000 4 times/month/line 

(weekly) 

77 
 

 

 

 

 

 

 

 

 

 

RTE Produots: 

• Provide testing off ood oontaci 

surfaces 

• Identify hold and test for 

posttive 

finding of L.m. or indicator 

organism 

• State frequency of testing 

• Identify size/location of 

sampling sites 

• Support testing frequency 

For Hotdog & De//. Type Produots: 

• ven -_!fy eor _. -e,,.1·ve a,.,,.1·0-s after r_ 1,,1 __ 11L n_ _ . 

initial posttive sample of food 

contacl suriace 

• Test and hold in the case of a 

second posttive 

• Sample and test lots to release 

OR rework to destroy L.m. 

*At least 3-5 samples per production line should be sampled each time (every 6 months, quarterly, 

monthly, biweekly, or weekly). 

**Establishments producing deli or hotdogs under Alt. 3 may decide to collect samples based on 

HACCP size or production volume. 

Alternative 3 producing Deli & Hot Dog products: 

The frequency for testing FCS for Lm or an indicator organism is expected to be greater in 

establishments that produce deli and hot dog type RTE products under Alternative 3. 

o

o Has the establishment verified corrective action after a positive test for Lm or an indicator 

organism on a food contact surface and have they implemented follow-up testing? 

o If follow-up testing resulted in a second positive test, did the establishment hold lots of product 

that may have become contaminated by contacting the food contact surface? 

When the establishment obtains a second positive test for Lm or an indicator organism during 

its intensified FCS sampling (follow-up testing), the establishment MUST hold product lots that 

may have become contaminated by contact with the food contact surface until test results 

indicate the establishment has corrected the sanitation problem that led to the positive test 

results. 

78 
 

 

 

 

 

 

 

 

 

 

 

 

 

Alternative 3 Follow-up Intensified Hold and test required* 

sampling sampling (recommended after 3rd positive) 

Alternative 3 (deli or Follow-up Intensified sampling 

hotdog) sampling required 

Hold and test required after 2nd positive. 

*Establishments in Alt. 2b and 3 (non-deli or hotdog producers) are required to identify when 

they will hold and test product. FSIS recommends that they do so after the 3rd consecutive 

Alternative 3 

Requirements Sanitation and Testina Proaram 

Non-deli Non-hotdoa Deli or hotdoa product 

Validale effecliveness of post-lelhality lreatment (PL T). Must be included as a CCP in 

the establishment's HACCP Plan and should show at least a 1-log reduction in Lm prior 

to distribution of the product into commerce. 

Document effectiveness of anlimicrobial agenl ar process: Must be included as part of 

the establishment's HACCP, Sanitation SOP, or Prerequisite Program and should 

demonstrate no more than 2-loas cirowth of Lm over the estimated shelf life. 

Sanitation Proaram Reauirements X X 

Testing food contact surfaces (FCS) in the post-lethality processing environment for Lm X X 

or an indicator oraanism. 

State testina freauencv. X X 

Identify size and location of sites to be sampled. X X 

Exolain whv testina freauencv is sufficient to control Lm or an indicator oraanism. X X 

ldentifv conditions for Hold-and-Test .when FCS (+l for Lm or an indicator oraanism. X X 

Additional Sanitation Prooram Reouirements X 

Follow-up testing to verify corrective actions are effective after 1st FCS ( +) for Lm or an 

indicator organism. Includes testing of targeted FCS as most likely source and additional X 

testinq of the surroundinq area 

If follow-up testing yields 2nd FCS (+), hold products that may be contaminated until 

problem is corrected as shown bv FCS (-) in follow-uo testina. X 

Hold and test product lots using a sampling plan that provides statistical confidence that 

the lots are not contaminated with Lm or an indicator organism. Release, rework, or X 

condemn products based on results. Document results and product disposition. 

Eslablishments in all three allernatives must rnainlain sanilalion in accordance with 9 X X 

CFR 41 6. 

o Did the establishment sample and test product before it entered into commerce? 

o Has the establishment documented the results of the testing? 

o Did they destroy the product or rework the product using a process that has been validated to 

achieve at least a 5-log Lm reduction? 

From the compliance guideline: 

When the establishment elects to use Alternative 3 for its RTE products, it may incorporate its 

sanitation measures and testing protocol for controlling Lm in the post-lethality processing 

environment into the HACCP plan, SSOP, or another prerequisite program. 

Review the HACCP plan, SSOP and/or prerequisite programs and the associated records to be 

familiar with the sanitation procedures and testing program that the establishment will employ to 

control Lm. 

If the sanitation measures for controlling Lm and testing protocol are in a prerequisite program 

other than the SSOP, the establishment must include the program and the results produced by 

the program in the documentation that the establishment is required to maintain in accordance 

with §417.5. 

79 
Increasing Risk Levels and Frequency of FSIS VerificatiOn Testing ➔ 

ALTERNATIVE 1 ALTERNATIVE 2 ALTERNATIVE 3 

Post-lelhality Treatment Post-lethality Treatment OR Sanitation and Testlng 

at:!Q Antimicrobial Antimicrobial A( ent or Process Program 

Agent or Process Choice 1: Choice 2: Non-deli, Deli or hot- Requirements Post-lethality Antimicrobial Agent Non-hOtdog dog product 

Treatment or Process 

Validate effectiveness of post-lethality treatment (PL n. Must be included as X X 

a CCP in the establishment's HACCP Plan and should show at least a 1 ~og 

reduction in Lm pnor to distribufion of the product into commerce 

Document errectiveness of antimicrobial agent or process: Must be Included X X 

as part of the establishment's HACCP, Sanitation SOP, or Prerequisite 

Program and should demonstrate no more lhan 2-logs growth of Lm over Ille 

estimated Shen l~e. - Sanltatlon Proaram Reaulrements X X X 

Testing food contact surfaces (FCS) in the post-lethality processing X X X 

environment for Lm or an Indicator organism. 

State testing frequency. X X X 

Identify size and locatiOn of srtes to be sampled X X X 

Ex~ain why testing frequency Is sufficient to control Lm or an Indicator X X X 

organism. 

Identify condrtions for Hold-and-Test, when FCS (+) for Lm or an indicator X X X 

oroanism. - - Additional Sanitatlon Program Reouirements 

Follow-up testing to verify corrective actions are effective atter t FCS (+) 

for Lm or an indicator organism. Includes testing of targeted FCS as most X 

likelY source and additiOnal testing of the surrounding area. 

If follow-up testing ~elds '!" FCS (+), hold products that may be 

contaminated until problem is corrected as shown by FCS (·) in follow-up 

testing. X 

Hold and test product lots using a sampling ~an lhat provides statistical 

confidence that the lots are not contaminated wrth Lm or an indicator 

organism. Release, rework, or condemn products based on results. 

Document results and product disoosition X 

Establishments in all three alternatives must maintain sanitation in X X X X X 

accordance with 9 CFR 416. 

80 
 

 

 

 

 

 

 

 

 

 

 

 

Control Alternatives 

Alternative 1 

Lowest risk and lowest 

level of FSIS Verification 

testing 

Alternative 2, Choice 1 

Increased risk from 

Alternative 1 and 

increased level of FSIS 

Verification testin 

Alternative 2, Choice 2 

Increased risk from 

Alternative 2, Choice 1 

and increased level of 

FSIS Verification testin 

The establishment uses a post-lethality treatment (PL T) 

to reduce or eliminate Lm in the product and an 

antimicrobial agent or process (AMAP) to limit or 

suppress growth of Lm in the product. 

The establishment uses a PL T to reduce or eliminate Lm 

in the product. 

The establishment uses an AMAP to limit or suppress 

growth of Lm in the product. 

RTE Sampling 

Unit Objectives 

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

• Describe the conditions for RTE product to be considered adulterated. 

• Describe the steps for performing a RTE sampling task (6 steps). 

• Describe what actions IPP take when a positive FSIS RTE sample result is identified. 

• Describe the actions IPP take when establishment testing obtains a positive sample result. 

FSIS sampling program is designed to verify: 

o Food safety systems are effective 

o FSIS performance standards/regulations are met 

Pathogens of concern in RTE products that FSIS samples for: 

o Listeria monocytogenes (Lm)-usually due to post-lethality contamination. 

o Salmonella-usually indicates a breakdown in the lethality step. 

RTE product is adulterated if it: 

Contains Lm, Salmonella or any pathogen known to cause illness, including E. coli O157:H7; 

Comes into contact with a food contact surface positive for Lm. 

81 
 

 

 

 

 

 

 

 

which product to sample and schedule in PHIS 

Step 1 - Determine which product to sample and schedule in PHIS. 

RTEPROD_RAND 

- Randomly collect any RTE product. 

- Includes post-lethality exposed products and those that are not. 

- Rotate through different products. 

RTEPROD_RISK 

- Follow risk-based priority list. 

- ONLY products that are post-lethality exposed. 

Step 2 - Notify Establishment Management 

Step 3 -Collect the sample: 

Step 4- Document Sample Collection in PHIS 

Step 5- Pack & Ship the Sample 

Step 6- Respond to Results 

82 
ACCP 

Processing 

Cat ories 

Fully CookedNot Shelf 

Stable 

Not Heat 

TreatedShelf 

Stable/ Heat 

TreatedShelf 

Stable 

Product with 

Secondary 

Inhibitors -

Not Shelf 

Stable 

RTE Samplin g Priority Lis t 

Finished Product 

Categories 

RTE f11Uy-cooked 

meat (PLE)1/ RTE 

fully-cooked poultry 

(PLE) 

RTE 

acidified/fermented 

meat (without 

cooking)-PLE/ RTE 

acidified/fermented 

poultry (without 

cooking)-PLE 

RTE dried meat 

(PLE)/ RTE dried 

oult PLE 

RTE salt-cured meat 

(PLE)/ RTE salt cured 

oult PLE 

RTE salt-cured meat 

(PLE)/ RTE salt cured 

poultry (PLE) 

Production Volume Categories (by 

Product Groups) 

Meat + Nonmeat Com onents 

Sausage Products 

Patties/Nu ets 

Other Fully Cooked Not Sliced Product 

RTE fermented meat sliced or not 

sliced)/ RTE fermented poultry (sliced or 

not sliced) 

(Acidified/Fermented Products) 2 

RTE dried meat (sliced or not 

sliced)/RTE dried poultry (sliced or not 

sliced) 

Dried Products 2 

RTE salt-cured meat (sliced or not 

sliced)/ RTE salt-cured poultry (sliced or 

not s liced) 

Salt-cured Products 2 

RTE satt-cured meat (sliced or not 

sliced)/ RTE salt-cured poultry (sliced 

or not sliced) 

(Salt-cured Products) 2 

PLE is defined as post-lethality exposed product. 2 Product type to be used on Form 10,210-3 . 

Risk 

Level 

6 

7 

8 

9 

10 

11 

11 

83 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sample Management 

Objectives 

After completion of this module, the trainee will be able to 

1. Describe the difference between directed samples and collector generated samples. 

2. Schedule a directed sampling task. 

3. State the purpose of the laboratory capacity reservation system. 

4. Document a directed sampling task. 

5. Cancel a scheduled sampling task from the Task Calendar. 

6. Check laboratory results. 

7. Print laboratory forms. 

8. Describe the method of collecting a sample for establishments with no internet access. 

References 

FSIS Directive 13,000.2 Rev. 1 Performing Sampling Task in Official Establishments using the 

Public Health Information System 7-25-2014 

FSIS Directive 10,800.1 Procedures for Residue Sampling, Testing and other responsibilities 

for the National Residue Program 7/12/2007 

PHIS Users Guide on InsideFSIS Intranet PHIS page 

Introduction 

The Sample Management feature of PHIS streamlines scheduling, assigning, documentation, 

and tracking of FSIS’s sampling tasks. IPP have the flexibility to schedule sample collection 

within the constraints of their particular assignment and the availability laboratory resources. 

For instance, IPP at the establishment can either schedule the sample collection on the Task 

Calendar or cancel the sampling task when a sampling task is assigned to an establishment. 

When the sample collector places the lab sampling task on his/her task calendar, PHIS makes 

a laboratory reservation. The system generates a unique sample collection form number and 

bar code, which can be printed, and provides questions which the sample collector must 

answer as part of the sampling task. 

Sampling Verification Programs and Sampling Tasks 

FSIS administers three sampling verification programs. 

• Microbiological sampling for food borne pathogens such as for E. coli O157:H7 on raw beef 

products, Salmonella sampling for raw products, and Listeria Monocytogenes and 

Salmonella on ready-to-eat (RTE) products. 

84 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• Carcass/tissue (kidney, liver, heart, or spleen) sampling for drug and chemical residues 

(antibiotics, pesticides, and heavy metals) to ensure that residue tolerance or action level 

established by FDA and EPA are not violated. 

• Carcass/tissue sampling for pathology determinations (e.g., disease conditions, 

wholesomeness, etc.) to determine if there is a risk to humans handling or consuming the 

meat or poultry products. 

Lab sampling tasks fall into two collection types. 

Directed Sampling Tasks displayed on the Establishment Task List are based on the 

sampling verification programs for which the establishment is eligible. Eligibility for a specific 

sampling program is determined by information entered in the establishment’s profile in PHIS 

such as the slaughter class, type of product produced or processed, and production volumes. 

One or more directed lab sampling tasks may be created by an authorized user (typically at the 

Headquarters or District level) and directed to specified establishments. 

Directed sampling notification is received through alerts on the inspector homepage. MT43 

sampling of raw ground beef and HC_CH_CARC01- HACCP Verification Sampling for Young 

Chicken Carcasses are examples of directed sampling tasks. Residue testing in poultry 

carcasses, such as the NRP_YC- National Residue Program Sampling-Young Chickens, is 

also an example of directed sampling that will be displayed on the establishment task list. 

Directed lab sampling tasks can also be created and distributed to an establishment based on 

a system-detected event such as a positive pathogen lab result. For example, MT44 sampling 

is a follow up sampling program in response to a MT43 positive E. coli O157:H7 test result. 

Note: Scheduling the task, reserving lab capacity, and documenting the collection of all 

directed sample requests is done through the Task Calendar and not the sample 

management left navigation menu in PHIS. 

Collector Generated Samples are not displayed on the Establishment Task List. For 

example, IPP assigned to livestock slaughter establishments may perform in-plant residue 

screening tests, such as the Kidney Inhibition Swab (KISTM) on suspect animals. In response 

to positive or indeterminate FSIS in-plant residue screening tests, the IPP may collect and 

submit confirmation samples to the lab for residue analysis. 

In situations where IPP need to collect other types of samples (e.g., species substitution or a 

food borne illness outbreak) they are to contact their Frontline Supervisor (FLS) through their 

supervisory chain of command and request sample collection. IPP are to provide information to 

the FLS on the type of sample to be collected and a justification for the sample collection 

request. Upon approval of the sample collection, the IPP will add the sampling task to their 

Task Calendar and complete the sampling task. 

Note: For all collector generated samples, the IPP will need to create a sampling task in 

PHIS by determining laboratory capacity, scheduling the collection date, and 

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documenting the collection of the sample. The mechanism for scheduling a sampling 

task and documenting collector generated samples varies in PHIS. 

• The entry of in-plant livestock residue screening results (both negative and positive) and 

the scheduling and submission of confirmation samples in response to positive or 

indeterminate in-plant screening test results is done through the Animal Disposition 

Reporting (ADR) left navigation menu tab. 

• The scheduling and submission of livestock pathology samples is done through the ADR 

left navigation menu tab. 

• The scheduling and submission of poultry pathology samples is done through the 

Sample Management left navigation menu tab. 

• The scheduling and submission of any other approved collector generated sample is 

done through the Sample Management left navigation menu tab. 

PHIS Laboratory Capacity Reservation System 

PHIS allows IPP to schedule sample collection tasks using the PHIS Laboratory Capacity 

Reservation System. The laboratory reservation system alerts the laboratory to expect the 

sample and ensures that FSIS laboratory resources will be available on the day the sample 

arrives. The requested collection date will be checked against the laboratory capacity and 

reservation module of PHIS. Confirmation will be provided indicating that there is available 

laboratory capacity on the requested collection date for the type of sample being collected. If 

capacity is not available, IPP are to select an alternate date. Once sample scheduling is 

completed, PHIS will display the address of the FSIS Laboratory that is scheduled to receive 

and analyze the sample. 

IPP will document information about the collected sample and submit the sample form 

electronically through PHIS, ensuring that sample information is in the laboratory data systems 

when the lab analysis is complete. Sample results are reported to IPP through PHIS and are 

accessed through the IPP’s Homepage. 

These features as a whole will enhance the efficiency of all sampling resources, including IPP 

time in collecting samples, lab workload to analyze samples, and the effort needed to process 

and report results. 

Remember 

• Sampling tasks should be scheduled to the task calendar using a realistic collection date 

based on the plant’s production schedule. This should be done as early as possible to 

ensure a capacity slot is available for the desired collection date. Once the sampling task 

has been moved from the task list to the calendar, a capacity slot is reserved to 

accommodate the scheduled sample. (See FSIS Directive 13,000.2 Rev. 1) 

• Scheduled sampling tasks should be canceled or rescheduled as soon as IPP are aware 

they will not collect on a scheduled date so capacity slots can be released for others to use. 

• Waiting to schedule sampling tasks in the last few days of the collection window may result 

in no capacity being available. 

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• Sampling for low and infrequent producers should be scheduled as far in advance as 

possible; IPP who encounter a ‘no capacity available’ issue should contact any laboratory 

to request a capacity slot be created. This may not be possible if the sampling is to occur 

late in the week and/or late in the sample collection window. 

General Instructions for Performing Sampling Tasks in PHIS 

The FSIS laboratory is completely dependent on IPP to properly collect, prepare, and ship the 

sample. The FSIS Sampling Form that accompanies each sample must be completely and 

accurately filled out. The IPP role in the sampling process is vital. The information entered on 

the form becomes part of a legal document. If mistakes are made during the collection of the 

sample or on the form, the lab will discard the sample. 

IPP are to review all relevant directives and notices associated with each verification sampling 

program and follow the instructions in those documents before collecting a sample. Links to 

FSIS Directives and Notices are available through the PHIS Homepage, under the “My 

Dashboard” tab in the “Smart Links” menu box. 

IPP are to refer to the PHIS User Guide and applicable Directives and Notices for detailed 

instructions on documenting FSIS sampling tasks using PHIS, including scheduling the 

sampling task, entering sample data, and printing sampling forms. 

IPP must print a laboratory sample form upon completion of the sample collection task, sign 

the form, and place it in the sample box with the collected sample. 

IPP are to refer to FSIS Directive 7355.1, Use of Sample Seals for Laboratory Samples and 

Other Applications, for instructions on packaging and sealing sample boxes to ensure the 

integrity of samples submitted to laboratories for analysis. 

First shift samples should be shipped the same day they are collected or they will be discarded 

by the laboratory. First shift samples may be collected Monday through Friday. Samples 

collected on the second shift and shipped the next day will not be discarded. Second shift 

samples may be collected Monday through Friday. 

Samples are mailed so they arrive at the FSIS lab the next day. Samples should not be held 

over the weekend if it is avoidable (not more than three days). If you hold the sample over the 

weekend, the sample must be frozen. (Friday to Monday) The current contract carrier will 

deliver on Saturdays, but not pick-up on a Saturday. With the newer expanded billable 

stamps, there is no need to designate Saturday delivery. 

Note: There is no requirement that residue samples be frozen if shipped the same day. They 

should be frozen if held overnight and then shipped as soon as possible. 

Ordering Sample Supplies

IPP should determine if adequate sampling supplies are on hand before collecting a sample. 

To ensure that the sample supplies are delivered to the correct location and in a timely 

manner, a physical address (no P.O. Box address) must be added as a “Laboratory Sample 

Supplies Address” in PHIS. 

The Laboratory Sample Supplies Address field is under the “General” tab in the Establishment 

Profile page. The address must be a valid physical location and zip code to ensure delivery by 

FedEx. 

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To order supplies, after adding the sampling task to the calendar, right click on the sampling 

task. From the drop down list, select Lab Sample Order supplies. A pop-up window appears 

with two read only fields (project code and FSIS laboratory filling request) and one Comments 

field. IPP are to enter text in the Comments field for the request and click Submit Request. A 

confirmation message appears. IPP are to close the pop-up. 

IPP may also submit requests for sampling supplies through Outlook: 

FSIS - Sampling Supplies - Western LabFSIS - Sampling Supplies - Midwestern Lab 

FSIS - Sampling Supplies - Eastern Lab 

In the Outlook message, provide the establishment name and number, IPP daytime phone 

number, project code for the scheduled sample, the scheduled date for sample collection, and 

the supplies needed. 

Note: Requests for histopathology sample supplies must be sent to the Eastern Lab and KIS 

supply requests need to be sent to the Midwestern Lab. However, if the KIS requests are 

made through the sample task option, PHIS will send the request to the appropriate lab based 

on the project code. 

Scheduling and Submitting a Directed Lab Sample 

IPP must use the Establishment Task List and Task Calendar when scheduling or collecting a 

directed sample. For each lab sampling project, IPP will add the sampling tasks on their Task 

Calendar. 

When scheduling a sampling task, IPP are to: 

• Refer to the collection date range (sampling window) indicated in PHIS for the requested 

sample. Schedule the sampling task as soon as possible to ensure lab capacity. Also, if the 

sample can not be collected on that date, reschedule the sample so the lab can 

accommodate other samples. 

• Use their knowledge of the establishment’s production schedules to schedule and the 

collect the requested sample when the product is being produced. 

• Ensure the establishment is given the opportunity to hold all product represented by the 

sample. 

• Consider the priority of sampling tasks relative to the tasks already on their calendars and 

ensure that the most important tasks are completed by the end of the month. 

• Ensure that sampling tasks are scheduled so that they can be completed within the time 

allowed for sample collection, as shown in PHIS. 

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To schedule a directed sampling task, IPP are to access the Establishment Task List, select 

the sampling task, and click the “Add” link adjacent to the Task Name to access the Assign 

Task pop-up window. In the pop-up window, IPP are to enter a sample collection date. The 

parcel pickup date (the date of sample pickup by the carrier) is generated when the sample 

collection date is entered and will default to the sample collection date. IPP change the parcel 

pickup date, if necessary, based on the availability of the carrier for sample pickup. IPP are to 

verify that there is laboratory capacity available for receipt of the sample for the parcel pickup 

date indicated. IPP click the “Save” button to schedule the sample and close the pop-up 

window. The sampling task will appear on the Task Calendar on the date scheduled. 

To complete a sampling task, IPP are to refer to the PHIS User or Quick Reference Guide for 

detailed instructions on entering sample collection data. To assist them in their sampling task, 

IPP may choose to print a draft copy of the sampling form from PHIS for use as a reference 

during sample collection and to document product information to be recorded in PHIS. IPP are 

to enter the data requested in the data fields provided. 

IPP will click on the Additional information tab and click on the Take Questionnaire link. 

IPP are to answer all the questions. If in doubt, IPP are to check the Mark for Review box in 

the upper right hand corner. IPP may research and answer the questions later. After IPP 

complete the questions, they are to click on Next. If IPP checked the Mark for Review box, 

these questions remain in a review status and IPP click on the Save and Close. If IPP choose 

Save and Close, the in progress Questionnaires are displayed from the My Questionnaires 

menu option. IPP may return to Lab Sampling with the Lab Sampling menu option or open the 

original requested questionnaire with Requested Questionnaire menu option. If IPP select 

Next, the Questionnaire is finalized and ready to be submitted. If IPP need to review a 

question again, they click Back. If not, IPP click Submit. If IPP click Close, the questionnaire 

is not submitted and IPP can review it later. 

When sample collection data entry is completed, IPP are to click the “Submit to Lab” button, 

print a finalized form, apply the sample seal label (barcode identifier) to form, sign the form, 

and place it in the sample box. PHIS will display a message stating that the sample collection 

information has been successfully submitted. 

1. Go to Task Calendar navigation menu 

a. Go to Establishment Task List 

b. Filter tasks by: Select Lab Sampling on the dropdown menu 

c. Select the establishment from the Select Establishment task list window 

d. Click Add to schedule a sample to your task calendar 

e. Right click on the task added to your task calendar and select Document 

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f. The Collection and Parcel Pickup dates will default to the date of the task. IPP 

change the Parcel Pickup date, if needed. Make certain the window shows 

available lab capacity. 

g. After scheduling the sample, collect the sample. 

h. After collecting the sample, right click on the task on the calendar and select 

Document. The Sample Collection window will open. 

i. Enter initial sample information and any additional information that is requested 

for completion. 

j. Click Save and Continue. 

k. After completion of sample information, if prompted, click Additional Info tab to 

complete a questionnaire. 

l. After completing each question, scroll to the bottom and click Save before 

advancing to the next question. 

m. After completion of all questions, click Submit to Lab button to transmit the 

information. The application will return a message stating the sample collection 

has been successfully submitted. 

n. Click Print Form at the top right of the page. Affix the sample ID seal in the 

designated space at the top center of the form. 

o. Sign and date the printed form. Place the signed and dated form in the shipping 

container with the sample. 

p. After the task has been scheduled and submitted, the task calendar will reflect 

the change under the “done” column on the task list. 

Note: Two common mistakes that result in FSIS laboratory employees discarding 

samples are failing to sign the paper copy of the sampling form and failing to submit the 

sample information electronically through PHIS in a timely manner. IPP are to pay 

particular attention to avoid these common mistakes. 

Rescheduling/Cancelling a Directed Sampling Task 

In situations where a scheduled sampling task cannot be completed on the scheduled date or 

within the designated time frame (e.g., product is not being produced during the directed 

sample task’s sampling window), the IPP must cancel and reschedule the sampling task if 

there is still time to collect the sample within the sampling window or completely cancel the 

sampling task from the task list. If IPP cannot collect the sample on the previously scheduled 

collection date, PHIS allows the collection date to be changed from the task on that date, once 

added to the task calendar. IPP are to right click on the task to be rescheduled and the 

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dropdown box opens. IPP are to select Cancel/Reschedule from the four available options: 

Information, Document, Cancel/Reschedule, and Order/Supplies. IPP are to click Reschedule 

this task as soon as they are aware that the sampling task needs to be rescheduled, and 

select a new Collection and Parcel Pickup Date and then click Save. The task shows up on 

the selected collection date on the Task Calendar. 

Collecting Samples at establishments with no internet access 

Method for IPP that collect samples at establishments that do not have internet access. 

PHIS has the ability to perform certain functions when the PHIS system is not actively 

communicating with the data server due to a lack of internet connectivity. Since some IPP 

perform sample collection, in establishments where internet connectivity is not available this 

capability allows IPP to perform part of the sample collection function in PHIS. 

When operating without internet access, PHIS cannot interact with the FSIS Laboratory 

Capacity Reservation System or transmit sample collection information to FSIS laboratories. 

IPP are to schedule sampling tasks on their task calendar while connected to the internet. 

Before leaving the establishment with internet connectivity to perform the sample collection at 

the establishment without internet connectivity; IPP are to open the scheduled sampling task in 

PHIS, enter whatever information is available at the time about the sampling task, and print 

two copies of the sample form. IPP are to take both copies of the printed form with them to the 

establishment. 

When they collect the appropriate sample(s) at the establishment, IPP are to document any 

remaining information by hand on both copies of the printed sample form. IPP are to sign one 

copy of the sample form and place that copy in the sample box. IPP are to close and seal the 

sample box with the sample and signed sample form inside before leaving the establishment 

where they collected the sample. IPP are to keep the second copy of the sample form with 

them as a record of the sample collection information to be recorded later in PHIS. Within 24 

hours, IPP are to return to an establishment in their assignment with internet connectivity, log 

into PHIS, select the sampling task from the task calendar and document the sample 

information using the information recorded by hand on the printed copy of the sample form. 

IPP are to submit the sample information to the laboratory by clicking “Submit” upon 

completion of data entry for all required data fields in the Sample Collection page. This will also 

mark the sampling task as completed on the task calendar. 

When IPP do not submit the sample information electronically within 24 hours of sample 

shipment, there is a risk that the FSIS laboratory will obtain results of the analysis before the 

electronic sample record has been created. When this happens, the laboratory will not be able 

to report the sample results electronically. In the rare event that FSIS laboratories are unable 

to report sample results electronically, they will report the results to the applicable district office 

by telephone or email. When this happens District Office personnel and the applicable 

Frontline Supervisor are to investigate why the electronic sample form was not submitted in a 

timely manner and initiate necessary action to prevent recurrence. 

Reporting Sample Results 

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Positive results are communicated via Alerts in PHIS on the Inspector’s Homepage. Sample 

history is posted in PHIS in the Establishment Homepage in the Laboratory Sampling panel. 

Positive and negative sample results are also tracked and posted in the Laboratory Information 

Management System, (LIMS)-Direct. IPP may access (LIMS)-Direct on FSIS computers, via 

FSIS Applications, Internet-Intranet, LIMS Direct. LIMS-Direct is a service that provides sample 

status and analysis result information for samples submitted to FSIS laboratories. Data is 

updated every 15 minutes. 

Information reported in LIMS-Direct includes: 

• Collection Date 

• Sample Form number 

• LIMS Number 

• Whether product is held, as specified in the sample form 

• Status of analysis 

• Result 

• Last Update 

Establishments may get individual sample results via e-mail if their e-mail addresses are 

entered into PHIS. The IIC should still inform the establishment of the results he or she 

obtains from LIMS-Direct or PHIS. Additionally, FSIS posts quarterly summaries of aggregate 

establishment set results on its website as an indicator of nationwide trends. 

RAW BEEF PRODUCT SAMPLING 

Objectives 

To demonstrate mastery of this module, you will 

1. Identify the pathogen of concern for raw beef products. 

2. Select from a list those raw beef products eligible for sampling. 

3. State where to find FSIS raw beef product sampling instructions. 

4. Explain the steps of raw beef product sampling. 

5. Describe how to determine which raw beef product to sample. 

6. State how sample results are received. 

7. State when to mail samples to the FSIS laboratory. 

8. List the actions associated with positive pathogen results. 

9. List the requirements for transportation of raw beef product which has tested positive or 

presumptive positive for a pathogen. 

10. Explain the IPP responsibilities for review of establishment sampling data. 

Introduction 

Throughout the history of meat and poultry production, various pathogenic bacteria have 

caused food borne illness. FSIS works with other governmental agencies, industry, and 

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consumer groups to set policy and establish performance standards to reduce or eliminate 

pathogens from meat and poultry products. 

CDC Estimates - The Centers for Disease Control and Prevention (CDC) estimates that there 

are approximately 175,905 domestically acquired foodborne illnesses associated with all Shiga 

toxin-producing Escherichia coli (STEC) annually. E. coli O157:H7 is the most well-known 

STEC and annually is responsible for approximately 63,153 (36%) of the domestically acquired 

foodborne STEC illnesses. The remainder of the illnesses associated with STEC (112,752 or 

64%) are caused by non-O157 STEC. While many STEC serogroups have been associated 

with human illness, 70 to 80 percent of confirmed non-O157 STEC illnesses are caused by six 

STEC serogroups – O26, O45, O103, O111, O121, and O145. These illnesses can be 

equivalent in severity to those caused by E. coli O157:H7. Illnesses from non-O157 STEC 

serogroups have been associated with ground beef products. FSIS tests beef manufacturing 

trimming from cattle slaughtered on-site for six non-O157 STECs. 

Hazard Analysis - E. coli O157:H7 is a food safety hazard that establishments need to 

consider in their hazard analysis if slaughtering, receiving, grinding, or otherwise processing 

raw beef products. Controls for E. coli O157:H7 should be adequate for non-O157 STEC. See 

Directive 10,010.2 Verification Activities for Shiga Toxin-Producing Escherichia coli (STEC) in 

Raw Beef Products for more information on verifying measures that an establishment may use 

to address STEC. 

Positive Product is Adulterated - Non-intact raw beef products such as ground beef or 

mechanically tenderized beef, which are contaminated with E. coli O157:H7 or one of six nonO157 STECs (O26, O45, O145, O103, O111, and O121) are adulterated. Intact raw beef 

products contaminated with E. coli O157:H7 that are intended to be processed into non-intact 

products are also adulterated. Beef manufacturing trimmings are an example of an intact raw 

beef product that is intended to be used for non-intact product such as ground beef. 

Establishment records and HACCP documents such as the hazard analysis should identify the 

intended use of intact raw beef products. By sampling for STEC, we're verifying that 

establishment's adequately address STEC in raw non-intact products and product components 

(adequate in this context means STEC is below detectable levels). Salmonella sampling, on 

the other hand, is a measure of process control, and Salmonella is not considered an 

adulterant in raw product. 

Purpose of Sampling - An objective of FSIS’s verification sampling program is to test for E. 

coli O157:H7 (and for some products, six non-O157 STECs) and as a result, stimulate industry 

actions to reduce the presence of that pathogen in raw beef products. 

FSIS microbiological sampling programs are part of FSIS verification activities to ensure the 

protection of public health. HACCP systems integrate science-based controls into food 

production processes. These controls must be combined with some means of verifying that 

meat and poultry establishments are achieving acceptable levels of food safety performance. 

Sampling programs are designed to verify that HACCP systems are effective in controlling 

harmful microorganisms in meat and/or poultry products. Establishments may also include a 

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microbiological sampling program in their HACCP system in order to verify that the system is 

performing as intended, that is, controlling, reducing or eliminating the identified food safety 

hazards. 

FSIS also protects public health by keeping pace with changes, such as emerging pathogens, 

new products and processes, and new laboratory analyses methods. FSIS is continuously 

improving its sampling protocol and techniques, updating sampling and testing programs, and 

developing more rapid means of reporting results. 

FSIS Directives 

5000.1 Verifying an Establishment’s Food Safety System 

5000.2 Review of Establishment Data by Inspection Program Personnel 

7355.1 Use of Sample Seals for Laboratory Samples and Other 

Applications 

7700.1 Irradiation of Meat and Poultry Products 

8080.1 Recall of Meat and Poultry Products 

10,010.1 Sampling Verification Activities for Shiga Toxin-Producing 

Escherichia coli (STEC) in Raw Beef Products 

10,010.2 Verification Activities for Shiga Toxin-Producing Escherichia coli 

(STEC) in Raw Beef Products 

10,010.3 Traceback Methodology for Escherichia Coli (E. Coli) O157:H7 in 

Raw Ground Beef Products and Bench Trim 

10,200.1 Accessing Laboratory Sample Information via LEARN (to be 

revised) 

10,210.1 Unified Sampling Form 

10,230.2 Procedures for Collecting and Submitting Domestic Samples for 

Microbiological Analyses 

13,000.2 Performing Sampling Tasks in Official Establishments Using the 

Public Health Information System 

FSIS Notices 

39-14 Clarification and Expansion of Sampling Eligibility Criteria for the 

Routine Beef Manufacturing Trimmings (MT60) and Bench Trim 

(MT55) Sampling Programs 

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FSIS Policy - FSIS directives contain policy details specific to sampling projects and 

programs. Policy changes rapidly; amendments and new issuances are developed to keep 

you informed. You are responsible for properly selecting products and using appropriate 

sample collection techniques to ensure the integrity of samples received by the laboratories. 

You must review the updated resources each time you take a sample. You should review new 

issuances when they are issued. 

The key policy related to raw beef sampling, FSIS Directive 10,010.1 Rev. 4, Sampling 

Verification Activities for Shiga Toxin-Producing Escherichia coli in Raw Beef Products, 

has been revised with instructions for collecting and submitting samples of raw beef products. 

Terminology 

Alternative Sampling and Lotting 

When an establishment meets very specific criteria, FSIS may agree to alternative sampling or 

alternative lotting. Follow applicable instructions outlined in FSIS Directive 10,010.1. 

Recall 

A recall is an establishment’s voluntary removal of distributed meat or poultry products from 

commerce when there is reason to believe that such products are adulterated or misbranded 

under the provisions of the Federal Meat Inspection Act (FMIA) or the Poultry Products 

Inspection Act (PPIA). 

Product that is adulterated and has left the establishment’s control may be subject to a recall. 

Contact the DO immediately if adulterated product has left the establishment’s control. (see 

FSIS Directive 8080.1, “Recall of Meat and Poultry Products”). The recall would involve at 

least the sampled lot, but the scope of the recall could be expanded depending upon a 

establishment’s control measures to limit potential contamination exposure. If the raw beef 

product, e.g., rework, was used as an ingredient in other raw product formulations, those 

secondary products could also be subject to recall. 

Sample 

A sample for raw products is a collection of product, such as ground beef or beef trimmings, 

that represents a larger amount of product (the sampled lot). A sample unit is an individual 

package or portion of product. It may take several sample units to make up one sample, 

depending upon the amount needed for the analysis. 

Sampled lot 

The sampled lot is the amount of product represented by the sample tested for E. coli 

O157:H7. The establishment defines the sampled lot. “Cleanup-to-cleanup” may be a part of 

the procedures that the establishment has in place to distinguish one portion of production 

from another portion of production. “Cleanup-to-cleanup” may be an effective means of 

preventing E. coli O157:H7 cross contamination between raw beef products during production. 

However, “cleanup-to-cleanup” without other supporting documentation may not be adequate 

to distinguish one portion of production from another (i.e., “cleanup-to-cleanup” is not a stand95 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

alone reason for distinguishing between segments of production because E. coli O157:H7 is 

source material contaminant). 

Factors or conditions that may determine the sample lot include an establishment’s: 

• Use of a scientific, statistically based sampling program for E. coli O157:H7 to 

distinguish between segments of product; 

• Sanitation Standard Operating Procedures (Sanitation SOPs) or any other prerequisite 

programs used to control the spread of E. coli O157:H7 cross-contamination between 

raw beef components during production; 

• Use of processing interventions that limit or control E. coli O157:H7 contamination; 

• Use of beef manufacturing trimmings and raw beef components or rework carried over 

from one production period to another production period; and 

• Production of bench trim, i.e., small pieces of beef trimmings from raw intact steaks and 

roasts. 

If multiple lots of raw ground beef product were produced from source materials from the same 

production lot of a single supplier, and some of this product was found positive for E. coli 

O157:H7, a scientific basis is necessary to justify why any other raw ground product produced 

at the grinder from the same source materials should not be considered adulterated. The use 

of source materials from multiple suppliers and establishment concerns related to potential 

recalls following a positive sample result are not a reason to not collect a sample. 

General Instructions for STEC Sampling Projects 

Establishment Interventions and CCPs 

Collect the sample after the establishment has completed production of a lot and applied all 

antimicrobial treatments to the production lot. 

If the establishment intends to test the product for E. coli O157:H7, non-O157 STEC or 

virulence markers before completing the pre-shipment review, you do not wait for the 

establishment to receive the test results before collecting and sending a sample to the FSIS 

laboratory. 

Collect fresh and not frozen product for STEC sampling. The only exception is if the 

establishment has a CCP for freezing in its HACCP plan, and freezing is a process that 

achieves a reduction in STEC. In this case collect the sample after the freezing step. 

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Random Selection 

All samples are selected randomly from the current day’s production of the raw beef product 

requested. Use a method for randomly selecting the production lot. You must randomly select 

a day, shift, and time within the collection window start and end dates indicated in the PHIS 

establishment task list. In order for the sample to be representative of a lot, every attempt 

must be made to avoid taking a sample that is biased, or non-random. There should be an 

equal chance that sampling will occur during all shifts that the establishment operates. One of 

the best ways to ensure an unbiased sample is to randomly select a time to collect the 

sample. You can use a random number table or generator to determine the day and time. 

Record the time you collected the sample in PHIS in the additional information questionnaire. 

All shifts and days are to be included in the random selection, including Fridays and 

night shift. 

Aseptic Sampling 

Samples must be collected using aseptic sampling technique. An aseptic technique implies 

that you do not add any organisms to the sample when it is collected. You want to assure that 

the sample is not contaminated with extraneous microorganisms from the environment, hands, 

clothing, sample containers and sampling devices. 

For raw beef products collected in their intact final package, such as ground beef in 1 lb. retail 

chubs, you are to clean and sanitize your hands before collecting the sample. For samples not 

in final packaging, such as beef manufacturing trimmings and bulk packaged ground beef 

products, you are to clean and sanitize your hands to the mid-forearm and put on sterile gloves 

before collecting the sample. The only items that should contact the external surface of the 

sterile glove on the sampling hand are the sample being collected and the sterile sampling 

equipment. You must put the samples collected from product packaged in institutional or bulk 

containers in the sterile Whirl-Pak® bags. Answer the questions on the additional information 

questionnaire in PHIS. Raw beef samples collected for E. coli O157:H7 sampling must be 

submitted to the laboratory in either the supplied sterile Whirl-Pak® bag or the establishment’s 

final packaging, or else they will be discarded. 

Sample Security and Shipping 

You must safeguard the security of the samples when preparing, storing, packaging, and 

mailing the sample to the FSIS laboratory. Samples are to be sent to the laboratory the same 

day they are collected, or as soon as the overnight courier service is available. 

Use the following guidelines: 

• Samples collected before Federal Express pickup Monday through Friday should be 

held refrigerated until shipped that same day. 

• Samples collected after Federal Express pickup Monday through Thursday should be 

held refrigerated overnight and shipped the next day. 

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• Samples collected during the weekend (after Federal Express pickup Friday through 

Sunday night) should be frozen and shipped on Monday. Note: If Monday is a holiday 

that Federal Express does not pick up samples, they may be held frozen until shipping 

on Tuesday. 

• The only time a frozen sample is collected is when the establishment has a CCP for 

freezing. If the establishment has a CCP for freezing, the sample you collect is frozen 

and must be kept frozen. 

Samples not meeting the above shipping criteria will be discarded upon receipt at the 

laboratory. 

Steps in Sampling 

There are 5 steps in product sampling. 

1. Determine which product to sample 

2. Notify establishment management 

3. Collect the sample 

4. Pack and mail the sample and form 

5. React to the results 

Step 1: Determine which Product to Sample 

When directed sample request tasks are sent to the establishment task list they will be specific 

to the type of product to be collected. The project code and the raw beef product or category 

is specified in the task name, for example “MT43 – Risk-based E. coli O157:H7 Sampling of 

Raw Ground Beef or Veal Products” or “MT60 – E. coli O157:H7 Sampling of Beef 

Manufacturing Trimmings”. More information about the sampling project code can be found in 

FSIS Directive 10,210.1, including special collection information. 

To assist you in determining which product to sample, you need to be familiar with the 

establishment’s processes and know how the finished product is labeled. Before collecting a 

sample, review the FSIS Notices and Directives covering that sample type or program. 

Ensure that the PHIS Establishment Profile is accurate. Update the profile as necessary to 

ensure the establishment is subject to the correct sampling tasks. An accurate 

Establishment Profile is critical – FSIS uses the information in the PHIS profile to generate 

specific sampling tasks. Refer to specific instructions in the Directives for updating the 

establishment profile based on the types of products produced and intended use. 

Sampling Project Codes 

The routine sampling project codes for E. coli O157:H7 testing at domestic federal 

establishments are: 

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• MT60 –Raw Beef Manufacturing Trimmings from cattle slaughtered onsite 

(Analyzed for E. coli O157:H7, non-O157:H7 STEC, and Salmonella) 

• MT64 –Components other than Trim 

(Analyzed for E. coli O157:H7 and Salmonella) 

• MT65 –Bench Trim, derived from cattle not slaughtered at the establishment 

(Analyzed for E. coli O157:H7 and Salmonella) 

• MT43 – Routine Testing of Raw Ground Beef in Federal Establishments 

(Analyzed for E. coli O157:H7 and Salmonella) 

• MT 60 - Beef Manufacturing Trimmings that are Sampled from Cattle Slaughtered at the 

Establishment 

MT60 is the sampling program for beef manufacturing trimmings sampled for E. coli both 

O157:H7 and the other non-O157 STEC, and Salmonella. Beef manufacturing trimmings are 

trimmings produced from cattle (including veal) that are slaughtered onsite, that is, at the 

establishment where the MT60 sampling is occurring. Beef manufacturing trimmings includes 

trim of any size; or primal/subprimal cuts, like chucks, rounds, or shanks; or boneless beef of 

any size, in any packaging. The MT60 sampling project covers any trim that is used at the 

slaughter establishment for non-intact use, or is intended for raw non-intact use by other 

establishments. 

The purpose of the MT60 beef manufacturing trimmings program is to assess the food safety 

controls the slaughter establishment has in place to address Shiga toxin-producing Escherichia 

coli (STEC) in the cattle it slaughters. MT60 test results reflect the effectiveness of the 

establishment’s slaughter and dressing operations because the trim is from cattle slaughtered 

onsite. 

In limited cases, beef manufacturing trimmings will be sampled at sister processing 

establishments that fabricate trim for their supplying sister slaughter establishments (FSIS 

Directive 10,010.1). 

If the establishment commingles the beef trimmings with beef product processed at other 

establishments, collect the sample before the establishment commingles the product. 

Randomly select only one type of trim to collect for each sample. 

Do not collect samples of beef manufacturing trimmings from production lots that are going to 

be further processed into ready-to-eat products or from lots of commingled beef manufacturing 

trimmings produced at different establishments. 

To determine the intended use of the products, review establishment records and HACCP 

documents such as flow charts, and hazard analyses. In cases where the establishment 

documents are unclear about the intended use, FSIS will sample the trimmings. 

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MT64 - Raw Ground Beef Components OTHER than Beef Manufacturing Trimmings that 

are Sampled 

Raw ground beef components other than beef manufacturing trimmings eligible for FSIS 

sampling for E. coli O157:H7 and Salmonella under the MT64 program are intact or non-intact 

beef products intended for manufacturing into raw ground beef products. Components include 

raw beef esophagus (weasand) meat, head meat, cheek meat, hearts, beef from advanced 

meat recovery (AMR) systems, and low temperature rendered products such as lean finely 

textured beef (LFTB), partially defatted chopped beef (PDCB) and partially defatted beef fatty 

tissue (PDBFT) that were produced from cattle slaughtered at the establishment. 

To determine the intended use of the products, review establishment records and HACCP 

documents. In cases where such documents are unclear about the intended use or consumer, 

or the establishment lacks control measures to ensure that the product is used as intended, 

handle the product as if it were for use in a ground beef product or other raw non-intact raw 

beef product. 

When you receive a directed sampling request task for the MT4 sampling project code, you 

choose randomly among the products produced at the slaughter establishment. Over time, all 

eligible products the establishment produces will be selected. 

If the establishment commingles components with beef product processed at other 

establishments, you need to collect the sample before the establishment commingles the 

product. 

Do not collect samples of components from production lots that are going to be further 

processed into ready-to-eat products at that establishment or another official establishment. 

If any of the components listed above such as heart meat, cheek meat or head meat are send 

to a retail store, these products should be sampled because the official establishment no 

longer has control over the intended use. 

Ammoniated Beef Products - Some establishments inject gaseous ammonia into low 

temperature rendered (LTR) beef products such as partially defatted chopped beef (PDCB), 

lean finely textured beef (LFTB), and product known as boneless lean beef tissue (BLBT)) to 

raise the pH of the product rapidly. Ammoniated beef products are typically intended as a 

component of raw ground beef and beef patty products. These products are produced from 

beef trimmings. The beef trim is warmed to partially melt and loosen the fat portion from the 

lean portion. The warming allows the connective tissue to be removed and also the edible fat 

portion can be separated from the lean beef using centrifugation. The edible fat portion can be 

further processed. The partially rendered beef trimmings are ground into a slurry. The sinew 

(tendon) and connective tissue are removed from the lean tissue in a subsequent step by 

forcing the slurry through a “desinewer.” The lean beef slurry is then ammoniated with 

gaseous ammonia to rapidly raise the pH to produce the antimicrobial effect. The ammoniated 

lean beef portion is rapidly frozen on a drum freezer, broken into chips, and sprinkled with 

pelleted CO2. Some processes then grind these chips and compress them into 60 lb. blocks 

using high hydrostatic pressure. The freezing and compressing steps typically provide an 

additional antimicrobial effect when combined with ammoniation. Scientific studies have 

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demonstrated that raising the pH of the product can reduce E. coli O157:H7 to an undetectable 

level in beef manufacturing trimmings. 

When you receive a sampling request task for the MT64 sampling project code in 

establishments that produce ammoniated (pH enhanced) beef products, you are to sample the 

ammoniated product after it passes the final antimicrobial treatment. Ammoniated beef 

products that are produced at non-slaughter establishments are also eligible for MT64 

sampling. 

MT65 - Bench Trim or Beef Manufacturing Trimmings that are Sampled from Cattle NOT 

Slaughtered on-site at the Establishment 

The purpose of the MT65 project is to verify the further processor’s food safety procedures for 

STEC, for example, purchase specifications, or antimicrobial interventions. Generally, the 

same types of beef products are sampled under the MT65 sampling program as under the 

MT60 sampling program. However, MT65 samples are from products derived from cattle not 

slaughtered at the establishment. 

The intended use is key - to determine it, review establishment records and HACCP 

documents. In cases where the establishment documents are unclear about the product’s 

intended use, the bench trim will be considered for use in raw ground beef products and other 

non-intact raw beef products. 

In addition, unlike the MT60 sampling program, if the establishment commingles beef 

trimmings from cattle it slaughtered with bench trim derived from cattle slaughtered at another 

establishment, those commingled beef trimmings are subject to sampling under the MT65 

sampling program. 

Do not collect samples of bench trim from production lots that are going to be given a full 

lethality treatment, e.g., further processed into ready-to-eat (cooked) products at the 

establishment or at another federal establishment. 

MT43 - Raw Ground Beef Products that are Sampled 

Raw ground beef products are subject to FSIS sampling for E. coli O157:H7 and Salmonella 

under the MT43 program. Raw ground beef products are described in the standards of identity 

for ground and chopped beef (9 CFR 319.15(a)), hamburger (9 CFR 319.15(b)), or beef patties 

(9 CFR 319.15(c)). They include: 

• ground or chopped beef or veal; 

• hamburger; 

• beef or veal patties; 

• beef or veal patty mix; and 

• similar ground beef or veal products made with added seasonings or ingredients. 

Sampled products may contain components such as beef derived from AMR systems, LFTB, 

or PDCB. 

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When an establishment produces multiple ground beef products and you receive subsequent 

sample request tasks for project code MT43 in PHIS, unless a specific product is requested, 

collect a sample from a different product than you submitted with the previous sampling task. 

You are to collect samples from products that contain a mixture of ground beef and non-beef 

species (for example, beef and pork patty mix), unless the product is labeled in a manner to 

show that beef is not the predominant meat or poultry component. For example, “Beef Patty 

Mix, ground pork added” (ingredients: beef, water, pork, corn syrup and seasonings) would be 

subject to sampling because beef is the predominant species in the product. You are also to 

collect samples from products that contain seasonings. 

Do not sample the ground beef product if the establishment only repacks intact packages and 

does not expose the product to the environment; for example, if the establishment removes 

product from bulk containers and breaks the bulk product it into consumer ready packages. 

Ground beef products intended to be further processed into ready-to-eat products, or 

products made with ground beef but subject to a different standard of identity than in 

§319.15(a)-(c), such as meatballs, meatloaf, beef sausage (§319.140), and fabricated steaks 

(§319.15(d) are not subject to E. coli O157H:7 sampling. 

Step 2: Notify Establishment Management 

Establishment management must be notified before a sample of its raw beef product is taken. 

Inform the establishment that it is required to hold or maintain control of the sampled lot until 

negative results become available. Since the establishment must hold the lot, it needs 

sufficient time to make the necessary arrangements to do so. You need to give the 

establishment enough advance notice so the sampled lot may be held but not enough time for 

the establishment to alter the production process. Always identify the reason why you are 

taking the sample when you notify the establishment. Inform establishment management that 

it is responsible for supporting its basis for defining what product is represented by the sample. 

You should discuss the notification and time frames with establishment management prior to 

any sample requests being received in order to have a notification protocol in place when a 

sample must be collected. 

You need to be knowledgeable concerning the establishment’s production practices. 

Give establishment management 1 day’s notice before you collect a sample if that’s enough 

time for the establishment to hold the sampled lot, or less than 1 day’s notice if it does not 

cause a hardship to the establishment. However, after becoming familiar with the 

establishment’s process, you may realize that 1 day’s notice before collecting a sample is not 

adequate time for the establishment to hold all of the product represented by the sample. You 

may provide 2 day’s notice, if necessary. 

If the establishment requests more than 2 days’ notice prior to collection of the sample, 

consider the establishment product and process flow. The District Office or the Policy 

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Development Staff (PDS) should be contacted for guidance before allowing more than 2 days’ 

notice. 

Each time you collect samples tested for adulterants such as STECs, verify that the 

establishment is holding or controlling product. If an establishment does not hold or maintain 

control of product, Write an NR because the establishment shipped product before FSIS found 

that the product was not adulterated, and because the establishment did not complete preshipment review following availability of all relevant test results, as required in 9 CFR 417.5(c). 

Also notify the District Office. 

Step 3: Collect the Sample 

Follow the general sampling instructions outlined in this handout. Randomly select a lot, day, 

shift and time for routine sampling. Collect a sample using aseptic technique from one 

completed production lot after all of the establishment’s antimicrobial interventions. Collect the 

sample from one type of trim or component. Select the sample within the PHIS sampling 

window. 

The N60 Sampling Method 

The N60 method is used for sampling both beef manufacturing trimmings (MT60) and bench 

trim (MT65). 

Before sampling, be sure you have the proper supplies. A plastic caddy, sharp boning knife, 

hook, sterile gloves and sterile sampling bag are needed for the N60 sampling procedure. It is 

critical that the knife used for sampling be kept sharp and properly steeled for collecting 

samples. Also available from the FSIS Western laboratory are disposable sampling surfaces, 

sanitizing solution, cut resistant mesh gloves, sampling templates and sanitizable clips which 

can be used to clip the wire at the top of the sampling bag to either the top of the combo bin or 

the edge of the sampling caddy during collection. The Whirl-Pak® sampling bags have a 

gusseted bottom (flat bottom) which allows the bags to stand without a rack or stand to hold 

them up. This allows you some assurance that the bag will be anchored in place while 

samples are cut and that the sampling bag will remain standing while sample pieces are 

placed in the bag. 

You are to sanitize the caddy, knife, and hook before collecting the samples by using the 

establishment’s sanitizing solution according to label instructions. If the establishment uses 

hot water only, then use hot water to sanitize sampling equipment. 

Use sterile gloves and handle all sanitized surfaces so that they do not become contaminated. 

To use the mesh glove in an aseptic manner when collecting samples, you place the sterile 

glove over the mesh glove. 

If a specific production lot is composed of greater than 5 containers, randomly select 5 

containers for sampling. If the specific production is composed of fewer than 5 containers, use 

the table below. 

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Number of Sample Pieces to Collect Per Container 

# of containers in each 

specific production 

# of sample pieces to select from each container 

5 12 pieces 

4 15 pieces 

3 20 pieces 

2 30 pieces 

1 60 pieces 

Aseptically collect the appropriate number of pieces of beef trim. Use the sanitized hook to 

reposition and anchor a piece of meat at the top of the container. For larger pieces of meat, a 

curved boning knife and short boning hook may work better than the standard meat inspection 

hook and straight boning knife. 

Cut off a slice of the surface that is approximately 3 inches long by 1 inch wide and 1/8 inch 

thick from each of the 60 pieces of meat. The priority is to collect samples from pieces of 

product taken from the original external surface of the beef carcass (this is the outside surface 

of the carcass when it is first dehided). You must make every effort to ensure that at least 

60 thinly (approximately 1/8 inch thick) excised external surface tissue samples are 

included in the sample. Using the sampling template to lightly score the surface in 2 parallel 

cuts approximately 1 inch apart and 3-4 inches long may facilitate obtaining the appropriately 

sized sample piece. The priority is to get the external surface of the carcass. Make sure that 

each sample slice contains some meat, that it isn’t completely fat. Also, collect only one slice 

from each piece of trim. 

For raw ground beef components, IPP are to use the Whirl-Pak® bag, but the fill line will not 

apply. When sample collection is completed, each bag will hold the equivalent of 325g of 

product. For beef manufacturing trimmings, each bag will hold 30 pieces. The laboratory will 

analyze the contents of one or two bags and hold a third bag as a reserve in case of a need to 

conduct additional analysis on positive samples. IPP are to use only the laboratory supplied 

Whirl-Pak® bags for submitting these samples. Do not use any other bag, for example a ziptop bag. 

The 60 pieces that are 3 inches long by 1 inch wide and 1/8 inch thick should weigh 

approximately 3⁄4 lb. (325g ± 10%). Place a total of 30 pieces in each of the first 2 bags for a total 

of 60 pieces. 

In addition, you are to collect available smaller pieces of meat from the same specific 

production lot and place this product in the third Whirl-Pak® sample bag. You do not need to 

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cut or trim the pieces to any particular dimension or count the pieces. You can just grab 

smaller pieces. However, you need to collect pieces with as much external surface area as 

possible. Cut larger trim pieces so they fit in the bag. Leave at least 2 inches of space at the 

top of the bag to prevent leakage. The total weight of the 3 bags of samples should be 

approximately 2 pounds. Do not under- or over fill the bag. 

Note: If an establishment produces both large pieces of trim and small pieces of trim, you are 

to sample only the product that can be sampled using the N60 sampling procedure. 

Aseptic Grab Sampling 

If the establishment only produces trim pieces that are too small to be sampled using the N60 

sampling procedure, just collect three grab samples aseptically up to the fill line for each of the 

3 Whirl-Pak® bags. If you are sampling larger components, such as hearts, you can collect 

one or more pieces to fill each of the 3 bags. Leave at least 2 inches of space at the top of 

each Whirl-Pak® bag to avoid overfill and leakage incidents. For component types that you 

can collect using a grab sample, such as AMR product or low temperature rendered products, 

you would collect 3 grab samples and fill up the fill lines of each of the 3 Whirl-Pak® bags. 

Always place samples taken aseptically from bulk packaged raw ground beef components in 

sterile Whirl-Pak® bags provided by the laboratory, not ordinary zip-top bags. 

Collecting Raw Ground Beef Products 

You are to collect a 2 lb. sample of ground beef product from the current day’s production in 

final packaged form (whenever possible). You are to put the product in its final packaging in 

the larger, non-sterile bag provided with the sampling supplies. Collect the appropriate 

number of packaged products so that the sample equals two pounds. For example, 2 1-pound 

packages may be included in the larger, non-sterile bag. If product in final packaging is not 

available, aseptically collect a 2 lb. sample using the grab sampling method, fill 3 Whirl-Pak® 

bags to the fill-line. When an establishment produces multiple raw ground beef products, the 

IIC should oversee sampling procedures to ensure that a different product within the requested 

product type is sampled each time a sample request form is received. 

Sampling Frequencies 

Maximum monthly sampling task frequencies for routine sampling programs vary by plant size 

and production volume, per Figure 1 in Directive 10,010.1. You must collect a sample 

whenever a sample request task is received and product is available during the collection 

window start and end dates. 

Analysis for Salmonella of all Beef Products Sampled for Shiga Toxin-Producing 

Escherichia Coli (STEC) 

Raw beef samples that are analyzed for STEC will also be analyzed for Salmonella. This 

analysis is used to gather baseline data to determine the prevalence of Salmonella in ground 

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beef and trim for future sampling program policy use. IPP are to inform the establishment that 

all samples analyzed for STEC will also be analyzed for Salmonella. The establishment only 

has to hold and control lots until the results for STEC are received. 

Collecting Supplier Information at the Time of Sample Collection 

IPP are to record source material and supplier information when they collect a sample of 

ground beef product (MT43) or bench trim (MT65) or any follow-up sampling for these 

sampling programs (MT44, MT52, or MT53) to be submitted to the FSIS laboratory for E. coli 

O157:H7 testing. This will serve FSIS’s goal to respond to FSIS positive results by identifying 

all affected product and all potential suppliers as quickly as possible to protect public health. 

When the establishment produced the source materials in-house that were used in the 

production of the sampled lot, you are to obtain and record the following information. 

• Establishment name and number, 

• Lot numbers or slaughter dates, 

• Production dates including slaughter production days if available, 

• Name of the beef components used in the production of the sampled product (e.g., beef 

trimmings, subprimal cuts, beef hearts, veal trimming, weasand, head or cheek meat) or 

any information that identifies the material, such as product labeling if used, and 

• Approximate amount of the beef component produced in each lot (in lbs). 

When the establishment uses source materials from another domestic establishment 

(outside source) to prepare the sampled lot, you are to obtain and record the following 

information. 

• Establishment name and number that produced the source materials, 

• Establishment phone number, 

• Establishment point of contact (name, title, e-mail address, and fax number), 

• Supplier lot numbers, 

• Production dates, 

• Name of the beef components used in the production of the sampled product, or any 

information from the label of the product that identifies the source material used, and 

• Approximate amount of the beef component produced in each lot (in lbs.). 

If the source materials are imported from a foreign establishment, you will need to gather 

additional information (country of origin, foreign establishment number, shipping mark, I-house, 

and bar-coding or other information to aid in identifying the product). 

You document source material and supplier information in a memorandum of interview (MOI) 

in PHIS. Provide a copy of the MOI to establishment management. You also make a note of 

any information that the establishment is unable to provide in the MOI. If the sample is 

reported as presumptive positive, notify management of the presumptive positive as soon as 

possible. 

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Also, when collecting for STEC record the sample source as: 

• Veal; 

• Beef; or 

• Mixed (beef and veal, or beef or veal and other species). 

This information will be recorded in PHIS when completing the sampling task. 

Step 4: Packing and Mailing the Sample 

On the day of sample collection, you will enter sample collection data and additional product 

info in PHIS, click “submit to lab” to submit the Sample Analysis Request Form electronically to 

the laboratory, and then you will print and sign the form and include it with the sample, in the 

sample shipment container. If the lab receives a sample with missing or incomplete paperwork, 

or if the sample is the wrong type of raw beef product, the lab will discard the sample. Also, if 

the lab receives an insufficient amount of product to perform the specified analyses, the 

sample is discarded (see Attachment 2 for discard reasons). Be sure the identification on the 

sample and the paperwork match, otherwise the lab will discard sample. 

All samples received by the lab without a collection date are discarded. 

The Sample Collection Data and Additional Information screens in PHIS for microbiological 

pathogen samples will have specific questions depending on the product requested. All 

requested data must be accurately recorded; otherwise the lab will discard the sample. For 

example, PHIS may ask for the date collected, the date sent to the lab, the product 

temperature, whether product was held by the establishment management, and whether the 

sample was collected in the final packaged form. There will be a question regarding with 

product is veal or beef. Other data requested may include the raw beef component sampled, 

the production volume, the shift, or other information needed for the type of sample submitted. 

One or more individually identified samples may be submitted in a shipping container. Follow 

the instructions in FSIS Directive 7355.1, “Use of Sample Seals for Program Samples and 

Other Applications.” You may need to include additional cooling packages in the shipping 

container to keep the sample or samples cool during transportation. To submit multiple 

samples, you may request larger boxes from the laboratory identified by sending an e-mail 

message to their e-mail addresses on page 9 of this handout. If you include more than one 

sample in the shipping container, include one of the identifiers (bar code) for the other sample 

on the Container Seal, 7355-2A. This lets the lab know that there are multiple samples in the 

box. The labs will discard them if it is not clear which sample goes with which sample form. 

Double-check and compare the address on the expanded billable stamp to make sure it is 

going to the lab indicated in PHIS and on the sample form. The lab will discard the sample if 

you mail it to the wrong lab. 

The shipping containers you receive should have the top and bottom sealed by the lab with 

tamper-evident tape. You will not receive any tamper-evident tape to use. If the tape is cut or 

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missing, do not open the container. Follow the instructions in FSIS Directive 7355.1 (seal it 

with the Container Seal, 7355-2A, and ship it back to the lab of origin for processing; complete 

the seal by writing “seal broken” in the “Form No.” blank). 

Pack the sample in this order. 

1. Absorbent pad 

2. Gel pack 

3. Cardboard separator 

4. Sample with paperwork (all in a zip-top bag) 

4. Foam plug 

5. Close the shipper with seal (7355-2A – Container Seal) 

To ensure the product is maintained at refrigeration temperature, place the sample in a prechilled shipping container with an absorbent pad and frozen gel pack, even if the sample was 

previously refrigerated or frozen. A piece of cardboard goes on top of the gel pack to separate 

it from the sample. Put a small bar code sticker from Form 7355-2 at the top center of the 

sample form and put the form in a plastic bag. Put another small bar code sticker on each of 

the bagged sample units. Put the sample and form into the larger zip-top bag and affix the 

Identification Label (7355-2B) to the larger bag. Note that the 7355-2B is a label rather than a 

seal and is simply stuck on the bag. There is no need to fold over and seal the bag with the 

label. The zip-top bag, containing the bagged sample and the paperwork, is put into the 

shipper. Filler material is not allowed in the shipping container. This means that no 

newspaper or paper towels should be put inside the shipping container to take up empty 

space. The foam plug must be pushed down as far as possible to keep the sample from being 

tumbled inside the shipper. Put any extra unused bar codes into the box so that the lab can 

account for them, or put them on the Container Seal where they won’t cover any written or 

printed information. Alternatively, if you keep a record of the sample, you can affix the extra 

bar code to your record. Close up the box and seal it. 

For sample integrity, a Container Seal (FSIS Form 7355-2A) must be put on the shipping 

container in such a way that it cannot be opened without disturbing the seal. 

Raw beef product samples are mailed to the laboratory on the first available day the contract 

carrier picks up after collecting the sample. Samples should be shipped when collected, do 

not wait for the establishment to complete their pre-shipment review for the product sampled. 

Double-check that the lab address in PHIS is the same as on the expanded billable stamp. If 

these are different, your sample will be discarded. If the lab listed is different from the one on 

the expanded billable stamp, e-mail the lab listed and request an expanded billable stamp from 

that lab. You should determine if you have a billable stamp for the correct lab when you first 

schedule the sample task, not when you are about to mail the sample. 

Check the expiration date on the expanded billable stamp. Do not use it if it is expired. 

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On the expanded billable stamp, enter the establishment number, shipping date (day sample 

box picked up by carrier) and the establishment’s phone number. 

Step 5: Results 

Access Laboratory Information Management System (LIMS)-Direct to track your sample 

receipt and results. LIMS-Direct is a computer application that provides sample data 

electronically to FSIS program personnel. LIMS-Direct reports sample status and the results of 

the analyses.. 

Check LIMS-Direct each day after you submitted the sample to the FSIS laboratory. If the 

sample was discarded, notify the establishment immediately so it can release the product. 

The first lab analysis is accomplished within two days of sample receipt. It is a screening test 

that identifies the possible presence of E. coli O157:H7 or one of the six non-O157 STEC. If 

the screening test is negative, E. coli O157:H7 is not present (or below detectable levels) in the 

sample tested. The negative results are posted in LIMS-Direct as “Acceptable”. FSIS 

resumes normal sampling at that establishment. 

Every FSIS verification sample that the laboratory confirms positive for E. coli O157:H7 goes 

through three stages of analysis. If the screening test is positive, the sample is potentially 

positive for E. coli O157:H7 and additional testing is necessary to confirm the result. The 

laboratory reports the sample result in LIMS-Direct as a “Potential Positive”. In the next stage, 

based on further analyses that reveal more evidence to suggest that E. coli O157:H7 may be 

present in the product, LIMS-Direct reports the sample result as “Presumptive Positive”. Upon 

further analysis and conclusive evidence that E. coli O157:H7 is present in the sample, the 

result is reported as “Confirmed Positive”. The confirmatory testing is usually accomplished 

within 3 to 4 days of the sample receipt at the FSIS laboratory, but can sometimes take longer. 

Every FSIS verification sample that the laboratory confirms positive for one or more nonO157 STEC serogroups also goes through three stages of analysis. If the screening test is 

positive, the sample is potentially positive for one or more non-O157 STEC serogroups and 

additional testing is necessary to confirm the result. The laboratory reports the sample result 

in LIMS-Direct as a “Potential Positive”. In the next stage, based on further analyses that 

reveal more evidence to suggest that one or more non-O157 STEC serogroups may be 

present in the product, LIMS-Direct reports the sample result as “Presumptive Positive”. Upon 

further analysis and conclusive evidence that one or more non-O157 STEC serogroups is 

present in the sample, the result is reported in LIMS-Direct as “Confirmed Positive”. The O 

group that was found to be positive will also be reported, for example O26 or O111. The 

confirmatory testing usually takes 3 to 4 days after the sample receipt at the FSIS laboratory, 

but can sometimes take longer. 

Presumptive positive and positive sample results are e-mailed to establishments that have an 

e-mail address in the PHIS establishment profile. Negative results are not e-mailed to the 

establishment. Even if the establishment receives sample result notifications by e-mail, 

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it is still your responsibility to notify the establishment when sample results are posted 

on LIMS-Direct. 

Note: Positive Salmonella results from raw ground beef samples submitted to the laboratory 

under project code MT43S will not have any immediate regulatory consequences. Therefore 

upon receiving negative E. coli O157:H7 results from the same sample (MT43) you are to 

notify the establishment that it may release any affected product on hold. If you receive the 

Salmonella results before the E. coli O157:H7 results, you should wait to notify the 

establishment until you receive the E. coli O157:H7 results. 

FSIS Actions after a Positive FSIS or another Federal or State Entity Sample Result 

FSIS Directive 10,010.2, Verification Activities for Shiga Toxin-Producing E. coli (STEC) in 

Raw Beef Products, provides instructions on the actions to take following a positive sample 

result. 

FSIS Presumptive Positive Sample Result 

The lab notifies the DO using BITES (Biological Information Transfer E-mail System) prior to 

posting the information in LIMS-Direct if the sample is presumptive positive for E. coli O157:H7 

or one or more non-O157 serogroups, if applicable. Because the laboratory confirms most 

“presumptive positives”, the contact person in the DO where the establishment is located alerts 

the establishment if the sample is “presumptive positive.” This ensures that the establishment 

receives that important message when you are not available. The DO contact will also inform 

the establishment if the results are confirmed positive. Even though the establishment may 

already know about the presumptive positive or confirmed positive result, you are still required 

to notify the establishment of the presumptive positive and confirmed positive result. 

Confirmed Positive Sample Result 

When an FSIS laboratory or another Federal (Agricultural Marketing Service-AMS) or State 

entity confirms a sample is positive for E. coli O157:H7 or a non-O157 serogroup the DO 

accesses the System Tracking E. coli O157:H7 – Positive Suppliers (STEPS), and opens a 

case file for the incident. The DO enters all the supplier information you gathered into STEPS. 

The DO is also responsible for determining whether any of the supplying establishments were 

also originating supplying slaughter establishments that produced the source materials 

that were used in the raw beef product that tested positive for E. coli O157:H7. Follow-up 

samples are collected from originating supplying slaughter establishments. 

With respect to supplying establishments that are not originating supplying slaughter 

establishments, the DO is to inform the IIC to collect supplier information on the source 

materials that went into the lot represented by the positive sample and forward the information 

to the DO. 

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Enforcement Actions Based on FSIS and Establishment Test Results 

Before you can determine whether to document the positive result as a noncompliance, you 

need to gather information. You need to determine if the establishment has its own E. coli 

O157:H7 sampling program for its raw beef products or whether it tests for non-O157 STEC or 

virulence markers. If the raw beef product sample you submitted is positive for E. coli 

O157:H7 or one or more non-O157 STEC serogroups and the establishment tested the same 

product, check the establishment’s test results to determine whether it also found the sampled 

product positive for E. coli O157:H7 or one or more non-O157 STEC serogroups. 

If the establishment held the product or maintained control of the product pending its own test 

results, and FSIS AND the establishment found the product positive for E. coli O157:H7 or one 

or more non-O157 STEC serogroups, you do not issue a noncompliance record (NR). For 

example, if a sample of beef manufacturing trimmings tested positive for E. coli O26 and the 

establishment tested a sample from the same lot and found it positive for E. coli O157:H7 you 

would not issue a noncompliance record because they found the product positive for a Shigatoxin producing Escherichia coli (STEC) organism. Even if the type of STEC positive did not 

match, you would still not an issue an NR. 

If the establishment has a documented procedure for diverting all product lots that are sampled 

by FSIS, you would issue an NR, unless the establishment also tested the product and found a 

positive. Verify that the product is diverted per the written program. The establishment must 

take corrective action per 9 CFR 417.3. If the establishment doesn’t take CA, then issue an 

NR. 

Issue an NR when FSIS finds product positive for E. coli O157:H7, but the establishment does 

not. Use a directed HACCP Verification task for the appropriate processing category, and cite 

§417.4(a) and §301.2 as the relevant regulations. Verify that the establishment has held onsite or maintained control of the affected product. When issuing the NR, review documentation 

to determine whether there have been previous NRs for positive product sampling, and if so 

consider whether it is appropriate to associate the NRs. 

In addition, if the establishment has its own testing program, review its records to determine if 

the establishment has found multiple E. coli O157:H7 positive results which would be evidence 

of a systemic problem. Verify the implementation of the Sanitation SOP by following the 

instructions in FSIS Directive 5000.1and 5000.4. Verify sanitary dressing procedures, if the 

positive result is from beef manufacturing trimming or other components produced at a 

slaughter establishment. If the establishment delays disposition of the positive product, you are 

to work with your FLS to determine how to work with the establishment to ensure timely 

disposal of the product. 

Establishment management must account for all affected products by identifying them and 

their location. Establishments are expected to ship only wholesome unadulterated product. 

The establishment is responsible for determining what product it holds and what it determines 

to be affected product. (FSIS Directive 8080.1 contains more information related to affected 

product.) If the establishment does not control its product, then take a regulatory control action 

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(retain product if it is available or take a withholding action per §500.3(a) (1) if the 

establishment shipped the adulterated product into commerce). If any affected product has left 

the establishment and it is no longer under the establishment’s control, notify the DO 

immediately. A recall may be recommended. 

Continuing with that HACCP Verification task, determine whether or not the establishment 

implements corrective actions that meet the requirements described in §417.3. The 

establishment must take corrective actions that meet one of the following requirements. 

• 417.3(a) if E. coli O157:H7 or STEC is addressed in the HACCP plan, or 

• 417.3(b) if E. coli O157:H7 or STEC is not addressed in the HACCP plan, or if it is 

addressed in prerequisite programs, or 

• 417.3(b) and 416.15 if E. coli O157:H7 or STEC is addressed in the Sanitation SOP. 

The establishment may need to conduct a reassessment of its HACCP plan or reevaluate its 

Sanitation SOP or prerequisite programs to meet these requirements. In addition, the 

establishment should reassess (§417.4(a) (3)) because something in the process has 

changed. Issue an NR if the establishment fails to take the appropriate corrective actions. 

In addition, you will conduct follow-up sampling, per instructions later in this module. You will 

verify that products that test positive for STEC receive appropriate disposition. Positive 

product may be treated with a lethality treatment to destroy the pathogen (cooking), rendered, 

or disposed of in a landfill. 

If product disposition is to occur off-site, verify that the establishment maintains appropriate 

control of the product as explained in the next section. 

Off-Site Disposition of E. coli O157:H7 or non-O157 Positive Product 

Raw beef products confirmed positive for E. coli O157:H7 or a non-O157 serogroup may be 

moved off-site for proper disposition, under appropriate controls. Product may be transferred 

to another official establishment for further processing to destroy the pathogen. 

Establishments may opt to dispose of the product through rendering or disposal in a landfill. 

Establishments may also divert product that is presumptive positive, rather than wait for a 

confirmation. Presumptive positive product must be controlled just like confirmed positive 

product. Establishments may use their own controls (company seals) or move the product 

under FSIS control (using USDA seals or FSIS Form 7350-1, “Request and Notice of Shipment 

of MPI Sealed Meat/Poultry”). When the product is destined for a landfill or rendering 

operation, it moves under company controls, because FSIS representatives are not at those 

locations to remove USDA seals or follow up with FSIS Form 7350-1. 

When the establishment moves presumptive positive or positive product off-site for disposition, 

verify the establishment that produced the positive product maintains appropriate control of the 

product at all times, including while it is in transit to the off-site location where the product will 

either be processed to destroy pathogens before entering commerce or be disposed of so it 

will not be used for human consumption. 

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When you perform a directed follow up HACCP Verification task verify that the establishment: 

• Maintained records identifying the official establishment, renderer, or landfill operation 

that received positive product; 

• Maintained control of product that was destined for a landfill operation or renderer while 

the product was in transit (through company seals); 

Note: If an establishment ships adulterated product to a renderer or landfill operation, 

you are to verify the establishment denatures the product before the product leaves the 

establishment (9 CFR 314.3). 

• Maintained control of product that was destined for an official establishment while the 

product was in transit (through company seals) or ensured that such product moved 

under FSIS control (under USDA seal or accompanied by FSIS Form 7350-1); 

Note: An instructional “For Cooking Only” statement on the container label is not a 

sufficient control. 

• Maintained records showing that every lot of product implicated by the positive test result 

received appropriate disposition, including documentation showing proper disposal of the 

product from the official establishment, renderer, or landfill operation where disposition 

occurred; and 

Note: Records of receipt at an official establishment, landfill operation, or renderer are 

not adequate to show that the product received appropriate disposition. Documentation 

(a record) from the official establishment, landfill operation, or renderer must show that 

the positive product was further processed to destroy E. coli O157:H7 or the specific 

product was destroyed. For example, a record of receipt and control until the product 

receives a lethality treatment. The record should include information necessary to identify 

the product, the number of pounds of raw beef product received and the number of 

pounds rendered or destroyed. 

• Completed pre-shipment review for the positive product only after it has received the 

records described above for that particular product. 

You cannot complete the HACCP Verification Task for the specific production until the 

establishment completes the corrective action and documentation requirements (417.3(a) or 

417.3(b) and 416.15), which includes receiving documentation from the official establishment 

or landfill operation or renderer that demonstrates proper disposition/disposal of every lot 

implicated by the positive result and conducts pre-shipment review of the corrective actions. 

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Note: If the product is shipped to another official establishment for disposition (for example, 

cooking), IPP at that establishment are to verify that the receiving establishment adequately 

addresses the pathogen in the product as part of their ongoing verification duties. 

Issue an NR if you find noncompliance while verifying the establishment’s off-site product 

disposition corrective actions. Document the noncompliance under the appropriate task, 

depending on where STECs are addressed in the establishment’s food safety system. 

Verification Activities at an Establishment Receiving E. coli O157:H7 or non-O157 

Positive Product 

If you are the inspection program employee at the establishment that receives raw ground beef 

products, beef manufacturing trimmings, or other raw ground beef components, or raw beef 

patty components that tested positive for E. coli O157:H7, you have certain verification 

functions to perform to ensure the establishment adequately addresses the pathogen in the 

product. 

When you perform a HACCP Verification task for such products, verify that the establishment: 

• documents receipt of presumptive or confirmed positive product (as per §417.5), 

• maintains control of the product, and 

• addresses the receipt E. coli O157:H7 in its hazard analysis, flow chart, and HACCP 

plan (which includes an adequate lethality treatment to destroy the pathogen). 

You are not required to be present at the establishment to verify the disposition of the raw beef 

product that is positive or presumptive positive for E. coli O157:H7 or one of the six non-O157 

serogroups. You can verify that the product received proper disposition through records 

review. 

Note: You are to verify that the establishment has supporting documentation validating the 

effectiveness of the lethality treatment during the Hazard Analysis Verification task. 

Note: FSIS does not require establishments to re-test product for E. coli O157:H7 after the 

establishment subjects the product to a lethality treatment adequate to destroy the pathogen. 

Document all noncompliance as per PHIS FSIS Directive 5000.1. 

FSIS Verification Activities at Supplying Establishments when a Raw Beef Product at an 

Official Establishment or Retail Facility Tests Positive for E. coli O157:H7 or a non-O157 

serogroup 

When raw beef products are confirmed positive, FSIS will conduct verification activities at 

supplier establishments, including the originating supplying slaughter establishment that 

produced the source materials that were used to produce the positive product. The DO will 

contact the IIC at each of the supplying establishments, including the originating supplying 

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slaughter establishments. If you are at the supplying establishment, remind the 

establishment that the notification is to ensure that the supplier knows that it could be the 

source of positive product. The IIC at the supplying establishment will ensure that a HACCP 

Verification Task is performed to verify that the supplier met all the HACCP regulatory 

requirements (monitoring, verification, recordkeeping, and corrective actions) at all CCPs in the 

HACCP plan for source material production lots sent to the establishment or retail facility 

where the positive was found. If the establishment has its own E. coli O157:H7 sampling 

program for its raw beef products, IPP are to review establishment records to determine if it 

has found multiple positive results which would indicate there is a systemic problem. IPP are 

to verify the establishment’s control of its sanitary dressing procedures during the beef 

slaughter Sanitary Dressing task per FSIS Directive 6410.1. In addition, perform a Hazard 

Analysis Verification (HAV) task to review the HACCP system. 

Multiple Follow-Up Sampling After an E. coli O157:H7 or non-O157 Positive Sample 

Result 

Each time that an FSIS routine sample or another Federal or State entity’s sample of raw 

ground beef product, ammoniated beef product, beef manufacturing trimmings, bench trim, or 

ground beef or raw beef patty components tests positive for E. coli O157:H7 or one or more 

non-O157 STEC serogroups, IPP will receive a directed sample task for 16 follow-up samples 

to sample product from the establishment that produced the positive raw beef product. IPP will 

also receive a directed sample task for 16 follow-up samples when FSIS follow-up samples of 

beef trimmings or other raw beef patty components or ground beef test positive for E. coli 

O157:H7 OR when an originating slaughter establishment is the sole supplier or a repeat 

supplier of the source materials implicated in positive sample result. IPP will automatically 

receive sample requests through PHIS to sample product from the establishment that 

produced the positive raw beef product. In addition, IPP will automatically receive sample 

requests as a result of a positive follow-up test of raw ground products. All follow-up sampling 

at originating slaughter establishments is generated by PHIS and the Policy Analysis Staff 

(PAS) as outlined in the next section. 

For low volume establishments, (establishments that produce less than 1000 pounds per day 

of the product to be sampled), 8 samples need to be collected instead of 16 samples. 

The type of sample requested will be based on the type of raw beef product implicated in the 

positive test result. The sampling project code will identify the type of raw beef product to 

sample. 

• MT44 Follow-up sampling of raw ground beef product in response to a MT43 or 

Agricultural Marketing Service (AMS) positive result in raw 

• MT52 Follow-up sampling at suppliers of beef manufacturing trimmings or other 

components from originating slaughter suppliers, in response to a MT43, MT65, or AMS 

ground beef positive result 

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• MT53 Follow-up sampling of trim or other components at the establishment that 

produced product in response to a MT60, MT65, MT64, or AMS trim testing positive 

• MT44T Follow-up sampling of raw ground beef, trim, or other component outside of 

projects MT44, MT53, and MT52 collected by IPP at Federally inspected establishment 

Sampling from production lots produced after the positive result starts as soon as possible 

following receipt of the follow-up sample requests. You DO NOT wait for the establishment to 

complete the corrective actions taken in response to the positive result before conducting 

follow-up sampling. 

If the establishment is not currently producing the type of raw ground beef component 

requested, you are to collect a sample of another component that is available. You are to 

sample beef manufacturing trimmings if the establishment is producing them. If the 

establishment is also not producing beef manufacturing trimmings, then you are to collect a 

sample of another type of raw ground beef component. 

As soon as the establishment resumes production of the product(s) to be sampled, start your 

sample collection at the following daily and weekly frequencies. Collecting follow-up samples in 

a timely manner is of vital importance. 

• Sample a maximum of 2 follow-up samples per shift per day, from different lots. 

• At a minimum collect 3 samples per week. 

You may submit more than one sample per shipping container if each sample is individually 

identified and the shipping container is large enough to hold more than one sample. Send the 

sample to the laboratory on the first available day the contract carrier picks up after collecting 

the sample. 

While you are collecting follow-up samples for STEC testing, you may receive a routine 

verification sample request form for a raw beef product to be tested for E. coli O157:H7 and 

potentially non-O157 (for beef manufacturing trimmings). In this situation, continue to collect 

follow-up samples and make follow-up sampling the priority, rather than routine sampling. If 

your workload and the establishment’s production practices allow it, collect the sample for 

routine testing within the allotted collection window. Do not collect a follow-up sample and a 

routine verification sample from the same product lot. If it is not possible for you to collect the 

routine sample, you should cancel the sample task and in the justification, state that you did 

not collect the routine sample because of follow-up sampling. 

While you are collecting follow-up samples for E. coli O157:H7 and potentially non-O157 

testing under one sampling project code, you may receive follow-up sample request forms for 

another project code or the same (repetitive) follow-up sampling project code. For example, 

you may be in the process of collecting the 16 follow-up samples under project code MT52 

when the 3rd sample of this set tests positive. As a result of this positive sample result, you will 

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receive 16 follow-up samples for project code MT53. You are to collect the rest of the 16 

follow-up samples from the MT52 project code as well as the 16 follow-up samples for the 

MT53 project code. 

FSIS will continue to collect follow-up samples after a positive follow-up sample result until the 

FSIS laboratory finds no positive sample results in 16 or 8 consecutive follow-up samples. 

For example, if you receive forms to collect 16 follow-up samples under the MT53 project 

code, and the 3rd sample of this set tests positive, you will then receive 3 more follow-up 

sampling forms for MT53 sampling program. As a result of the positive sample result, you 

would collect the remaining 13 follow-up samples and the 3 new follow-up sampling forms for a 

total of 16 follow-up samples. 

Follow-up Sampling at Supplying Establishments 

FSIS has implemented a follow-up sample testing protocol for establishments that supply raw 

beef products to establishments that have had product test positive for E. coli O157:H7. 

PHIS generates follow-up sampling tasks at supplier establishments. PHIS will send 16 followup sample request tasks if the originating slaughter establishment was the only supplier, or if 

an originating slaughter establishment is a repeat supplier for each source material used in the 

positive raw beef product. However, when a supplier is not the sole supplier or a repeat 

supplier, PHIS requests a single follow-up sample from the supplier for each source material 

used in the positive raw beef product. 

The DO informs IPP of which type source materials the establishment supplied to the beef 

boning, cut-up, or grinder facility, so that IPP can sample that raw beef source material from 

the establishment’s current production. If the originating supplying slaughter establishments 

produced more than one source material used by the boning, cut-up or grinding establishment, 

PHIS will generate sample request tasks, for each type of source material. 

In combination slaughter/processing establishments, if FSIS or another Federal or State entity 

finds a raw ground beef product positive, and the establishment produced the source materials 

used to produce raw ground beef product that tested positive, PHIS generates MT53 sampling 

program request tasks. IPP are to collect either 8 or 16 samples, based on establishment 

production volume, of the type of source materials used in the positive raw ground beef 

product. IPP are not to collect follow-up samples of the ground beef product. 

If ammoniated low-temperature-rendered (LTR) product was used as a component in raw 

ground beef products that tested positive for E. coli O157:H7, PHIS generates follow-up 

sample request tasks. IPP are to collect a sample of ammoniated beef trim at the 

establishment that produced the LTR product, even if that establishment is not an originating 

supplying slaughter establishment. 

If a sample collected under follow-up sampling program tests positive, PHIS generates multiple 

follow-up sample requests. 

Follow the sample collection instructions previously covered in this handout. 

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Establishment-Generated Sampling 

Some establishments have their own sampling and testing programs for E. coli O157:H7, nonO157 STEC or virulence markers. Establishments are not required to sample and test their 

raw beef products or raw materials for E. coli O157:H7 or non-O157 STEC or virulence 

markers. What establishments are required to do is to conduct a hazard analysis and support 

the decisions they make in their hazard analysis. Sampling and testing is one way to support 

decision-making. 

Establishments may address their sampling programs in the HACCP system, in either the 

HACCP plan, Sanitation SOP, or in a prerequisite or other supporting program. Even if these 

programs are not addressed in the HACCP system, establishments are still required to share 

records and analyses results with FSIS. 

No establishment that produces raw ground beef products or beef manufacturing trimmings 

and raw ground beef and beef patty components intended to be used in non-intact product 

is exempt from FSIS verification testing for E. coli O157:H7, even when the establishment has 

its own robust testing program for E. coli O157:H7, non-O157 STEC or virulence markers. 

Pre-shipment Review - FSIS has taken the consistent position that establishments can 

conduct pre-shipment review when the product is at locations other than at the producing 

establishment provided that the product does not leave the control of the producing 

establishment. Some establishments analyze samples for STEC while they are moving the 

product, but the product is still under the establishment’s control 

Review of Establishment Data - Based on the regulatory requirements of 9 CFR 

417.2(a)(1)(2) and 9 CFR 417.5(a)(1), FSIS believes that the results of any testing that the 

establishment performs that may have an impact on the establishment’s hazard analysis are 

subject to FSIS review and must be available to IPP upon request, including records from 

prerequisite programs. FSIS Directive 5000.2 states that, on at least a weekly basis, you 

must review the results of any testing and of any monitoring activities the establishment 

performed that may have an impact on the hazard analysis. There is a task in PHIS, “Review 

of Establishment Data” to document the performance of this review. Based on review of 

establishment records, if you have concerns about the design of testing, monitoring, or 

verification activities outside of a HACCP plan, or concerns about results from such activities, 

procedures, or prerequisite programs, contact the Policy Development Staff (PDS) or raise the 

concern through supervisory channels. When records show that the establishment tests beef 

trim and raw ground beef components for E. coli O157:H7, but never finds any positives, you 

are to contact the DO. In addition, when establishment testing records show multiple positive 

results for E. coli O157:H7, non-O157 or virulence markers that may be evidence of a systemic 

problem, you are to contact the DO. It may be determined that an EIAO needs to conduct a 

food safety assessment to assess such factors as what the test results reveal about food 

safety and whether the design of testing, procedures, or prerequisite programs are adequately 

supported by the decisions made in the hazard analysis. 

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If the Establishment Rejects Product From Suppliers - An establishment may sample raw 

beef products for E. coli O157:H7, non-O157 STEC or virulence markers when they are 

received and hold the production lot pending the sample result. If the product is presumptive 

positive or positive for E. coli O157:H7 or non-O157, the establishment considers the product 

to be adulterated, does not accept the production lot, and returns the lot to the supplying 

establishment using FSIS Form 8140-1, “Notice of Receipt of Adulterated or Misbranded 

Product” under appropriate controls (e.g., company seals or FSIS seals). After the 

establishment notifies you that it has rejected the production lot, collect the supplier 

information. You need to notify the DO (9 CFR 320.7) and include the supplier information in 

your e-mail. The DO is to notify the IIC at the supplying establishment that rejected product is 

being returned and have IPP at the establishment conduct a HACCP Verification task on the 

affected lot of product. 

Note: The Agency recognizes that it is probable that, despite the ongoing processing 

interventions for controlling E. coli O157:H7 and non-O157 STEC, some establishment 

samples of beef manufacturing trimmings and raw ground beef and beef patty components 

may test positive for E. coli O157:H7 or one or more of the six non-O157 STEC serogroups 

tested for by FSIS. These positives may be random events caused by normal process 

variation, or may have an identifiable, assignable cause that can be acted upon as part of 

corrective actions. Establishment verification testing should occur at a frequency to help 

determine the difference between acceptable process variation and assignable cause variation 

in the testing results associated with beef manufacturing trimmings and raw ground beef and 

beef patty components. Through this statistical analysis, the establishment will be able to 

justify whether corrective actions to address an assignable cause are appropriate and 

sensible. 

If the Establishment Performs Only Screening Tests - If review of the establishment’s E. 

coli O157:H7 and/or non-O157 sampling program reveals it is only performing screening tests 

and not further analyzing “potential positive” test results to determine whether E. coli O157:H7 

or non-O157 is isolated from the product, e.g., presumptive positive or confirmed positive, you 

are to verify that the establishment appropriately addresses the product as if the product is 

positive for E. coli O157:H7 or non-O157. The establishment cannot perform a second 

screening test for E. coli O157:H7 or non-O157 on the product and find it negative. Performing 

additional screening tests does not negate the original positive screening test. A screening 

test is not a conclusive (specific) test for the pathogen. 

If the establishment has a positive result from its own sampling program -

The establishment is not obligated to notify FSIS when it receives a presumptive positive or a 

positive sample result, but it must take corrective actions that meet the requirements of 

§417.3 each time a presumptive positive or a positive result is obtained. The establishment 

must also maintain appropriate control for any product that is presumptive positive or 

confirmed positive for E. coli O157:H7 or one of the six non-O157 STEC serogroups that is 

shipped to another establishment, or to a landfill or renderer for appropriate disposition. 

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FSIS Actions - When you are aware that there was a presumptive positive or positive result in 

establishment testing, you must: 

• Conduct a HACCP Verification Task to verify the establishment’s corrective actions 

(§417.3(a) or (b)), and 

• Issue an NR only if the establishment fails to implement the corrective actions that meet 

the requirements of §417.3(a) or (b). 

Note: The HACCP Verification Task cannot be completed until pre-shipment review is 

completed, which includes the establishment’s review of disposition documentation. 

Summary 

Currently, several STEC serogroups – E. coli O157:H7 and six non-O157 STEC (O26, O111, 

O121, O45, O145, O103) are a public health concern associated with raw beef products. 

Therefore, FSIS is analyzing beef manufacturing trimmings, bench trim, other raw ground beef 

components and ground beef for E. coli O157:H7. FSIS is also currently analyzing beef 

manufacturing trimmings for six non-O157 STEC in addition to E. coli O157:H7. 

If you are assigned to a beef establishment you may perform sampling for food safety 

concerns. 

When an FSIS sample for a raw beef product is confirmed positive for E. coli O157:H7 or one 

or more of the six non-O157 STEC, and the establishment has not found the same product to 

be positive, issue an NR for HACCP noncompliance, verify the establishment’s corrective 

actions, check appropriate decision-making documents, assist as needed in any recall, and 

conduct a HACCP Verification task on the specific production that tested positive. You cannot 

complete the task until the establishment has taken corrective actions and the product has 

received proper disposition (including completing a pre-shipment review). If the establishment 

maintained control of the product and sampled it, and both the establishment and FSIS 

samples were found positive for E. coli O157:H7 or a non-O157 STEC serogroups, you are 

NOT to issue a Noncompliance Record. You must verify that the establishment’s corrective 

actions meet the requirements in §417.3. 

If you find regulatory noncompliance, e.g., the establishment fails to take corrective action in 

accordance with §417.3, while performing the HACCP Verification Task, document it on an NR 

(as per FSIS Directive 5000.1). If you find that the establishment moved positive product 

without the necessary controls, or if you find that the establishment does not have records 

documenting proper disposition of the positive product moved off-site, contact your DO through 

supervisory channels. 

As new technologies and methods of producing products are developed, and as new 

pathogens emerge that affect meat and poultry food safety, FSIS will adjust its efforts to 

continue being a public health agency. New or different microorganisms may be added to the 

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list of those for which the Agency currently tests. It will continue to be the responsibility of the 

in-plant inspection force to verify that establishments meet their food safety obligations. 

Pathogen Reduction – Salmonella and Campylobacter Performance Standards 

Verification Testing 

Objectives 

To demonstrate mastery of Pathogen Reduction the trainee will: 

1. Explain why Salmonella and Campylobacter testing is used. 

2. State who will conduct Salmonella and Campylobacter testing. 

3. List the species and types of product eligible for testing under the Salmonella and 

Campylobacter performance standards. 

4. Describe how and when Salmonella and Campylobacter samples are taken. 

5. Explain how FSIS uses the moving window approach when assessing process control. 

6. Explain how to obtain completed Salmonella and Campylobacter results from LIMS-Direct 

and PHIS. 

7. Recognize the description of the three process control categories. 

8. Explain the Agency’s actions when an establishment has failed a Salmonella performance 

standard for chicken and turkey carcasses, raw chicken parts, or not ready to eat 

comminuted poultry products. 

References 

1. FSIS Directive 7355.1, “Use of Sample Seals for Laboratory Samples and Other 

Applications”. 

2. FSIS Directive 10,210.5, “FSIS Sampling Data Reporting Through Laboratory Information 

Management System – Direct”. 

3. FSIS Directive10,250.1, “Salmonella and Campylobacter Verification Program for Raw 

Meat and Poultry Products”, and the DVD titled, “Sampling Raw Meat and Poultry for 

Salmonella”. There are a list of supplemental documents containing information and 

instructions about the agency’s sampling programs. 

4. PHIS Directive 13,000.1, “Scheduling In-Plant Inspection Tasks in the Public Health 

Information System (PHIS)”. 

5. PHIS Directive 13,000.2, “Performing Sampling Tasks In Official Establishment Using the 

Public Health Information System”. 

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6. PHIS Directive 5300.1, “Managing the Establishment Profile in the Public Health 

Information System (PHIS)”. 

7. Federal Register Notice, Vol. 77, No. 235, December 6, 2012 (Docket No. FSIS 2012-

0007), “HACCP Plan Reassessment for Not-Ready-to-Eat Comminuted Poultry Products 

and Related Agency Verification Procedures”. 

8. Federal Register, Vol. 79, No. 108, June 5, 2014 (Docket No. FSIS-2012-0038), “Changes 

to Salmonella Verification Sampling Program: Analysis of Raw Beef for Shiga ToxinProducing Escherichia coli and Salmonella”. 

9. Federal Register Final Rule, Vol. 79, No. 162, August 21, 2014 (Docket No. FSIS-2011-

0012), “Modernization of Poultry Slaughter”. 

10. Federal Register Notice, Vol. 80, No. 16, January 26, 2015 (Docket No. FSIS-2014-0023), 

“Changes to the Salmonella and Campylobacter Verification Testing Program: Proposed 

Performance Standards for Salmonella and Campylobacter in Not-Ready-to-Eat 

Comminuted Chicken and Turkey Products and Raw Chicken Parts and Related Agency 

Verification Procedures and Other Changes to Agency Sampling”. 

11. Federal Register Notice, Vol. 81, No. 28, February 11, 2016 (Docket No. FSIS-2014-0023), 

“New Performance Standards for Salmonella and Campylobacter in Not-Ready-to-Eat 

Comminuted Chicken and Turkey Products and Raw Chicken Parts and Changes to 

Related Agency Verification Procedures: Response to Comments and Announcements of 

Implementation Schedule”. 

12. Federal Register Notice, Vol. 83, No. 218, November 9, 2018 (Docket No. FSIS-2018-

0043), “Changes to Salmonella and Campylobacter Verification Testing Program: Revised 

Categorization and Follow-up Sampling Procedures”. 

13. PHIS User Guide 

14. “IPP Help” as a menu item under FSIS Applications; can access the following topics which 

contains all the pertinent information needed to collect samples under the different 

sampling project codes: 

• Raw Poultry Sampling Project Guidance 

• Follow-up Sampling Salmonella 

• Religious Exempt and Low Volume Poultry Carcass Sampling 

• Raw Pork Sampling Project Guidance 

15. FSIS Notice 17-19, “Follow-up Sampling in Raw Poultry Establishments Not Meeting 

Salmonella Performance Standards”. 

16. FSIS Notice 21-19, “Actions to Take in Raw Poultry Establishments Exceeding Salmonella 

Performance Standards” 

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Introduction 

FSIS established the Salmonella verification program in 1996 as part of the Pathogen 

Reduction, Hazard Analysis and Critical Control Point (PR/HACCP) Systems Final Rule. The 

PR/HACCP Final Rule established Salmonella performance standards that are used to verify 

process control in meat and poultry slaughter and processing establishments that produced 

certain classes of product (9 CFR 310.25(b)(1) and 381.94(b)(1), respectively). The 

performance standards were developed using national baseline studies conducted before the 

rule’s implementation. Only the performance standards for livestock carcasses (9 CFR 

310.25(b)) are still applicable. Actually, the Agency tests all raw beef samples collected under 

the routine and follow-up sampling programs for E. coli O157:H7, non-O157 STECs, and 

Salmonella as per FSIS Directive 10,010.1, Revision 4. 

The purpose of the microbiological performance standards, for the reduction of Salmonella in 

raw products, is to allow FSIS to verify whether establishments have effective process controls 

to address Salmonella. 

Since the PR/HACCP Rule, FSIS has conducted additional prevalence and risk assessments 

for pathogens in FSIS regulated products, as well as revising the performance standards to 

meet public health goals. In addition, the agency has published a number of Federal Register 

Notices (FRN). 

• In 2014, FSIS published the Modernization of Poultry Slaughter Inspection, Final Rule 

(Federal Register Docket No. FSIS-2011-0012; August 21, 2014) to facilitate pathogen 

reduction in poultry products, improve the effectiveness of poultry slaughter inspection, 

make better use of Agency’s resources, and remove unnecessary regulatory obstacle to 

innovation. In this publication, FSIS informed industry that it was removing the codified 

Salmonella pathogen reduction performance standards for poultry (9 CFR 381.94(b)). 

• In January 2015, the Agency identified new Salmonella and Campylobacter 

performance standards for raw chicken parts and NRTE comminuted poultry products. 

(FRN Docket No. FSIS-2014-0023; January 26, 2015). FSIS also announced that it 

would use the results of routine sampling throughout the year, using a moving window 

approach, to assess whether the establishment’s processes are effectively addressing 

pathogens on poultry carcasses and other products derived from these carcasses. 

• In February 2016, FSIS published new performance standards for Salmonella and 

Campylobacter in not ready-to-eat (NRTE) comminuted chicken and turkey products, in 

addition to raw chicken parts (FRN Docket No. FSIS-2014-0023; February 11, 2016). 

The Agency also announced that it would begin assessing whether establishments 

meet the pathogen reduction performance standards for Salmonella/Campylobacter in 

raw chicken parts and NRTE comminuted chicken and turkey products. Furthermore, 

FSIS reassessed the minimum number of samples to assess process control for broiler 

carcass. 

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• In November 2018, FSIS is revising the categorization and follow-up sampling 

procedures in relation to the pathogen reduction performance standards. The 

establishment’s category status will be based on FSIS results during the 52-week 

window and will no longer include follow-up sampling results as part of the moving 

window. In addition, the agency intends to use the revised categorization procedures for 

all establishments subject to a pathogen reduction performance standard for Salmonella 

or Campylobacter, including beef and pork establishments (in the future). 

FSIS originally selected Salmonella as the target organism because it is a commonly reported 

cause of foodborne illness and is present in all major species. The Salmonella genus includes 

over 2,300 serotypes. There are several Salmonella serotypes commonly associated with 

human illness, including Salmonella Enteritidis and Salmonella Typhimurium. Salmonella 

bacteria are the most frequently reported cause of foodborne illness. According to the Centers 

for Disease Control and Prevention (CDC), salmonellosis causes an estimated 1.4 million 

cases of food borne illness and more than 400 deaths annually in the United States. 

Campylobacter species, specifically C. jejuni and C. coli, are most often isolated from the 

intestinal tract of poultry as well as in poultry products. Campylobacter bacteria are the second 

most frequently reported cause of food borne illness, and Campylobacter jejuni is the most 

common strain causing illness. 

Salmonella and Campylobacter contamination of raw poultry products occurs during slaughter 

operations, as well as during the live-animal rearing process (e.g., on-farm contamination can 

coat the exterior of the bird and remain attached to the skin). Contamination can be minimized 

with the use of proper sanitary dressing procedures and by the application of antimicrobial 

interventions during slaughter and fabrication of the carcasses into parts and comminuted 

product. In addition, if raw poultry is improperly handled during food preparation, Salmonella 

and Campylobacter can cross-contaminate other foods or food contact surfaces. 

Salmonella and Campylobacter can be transmitted to humans by eating foods contaminated 

with animal feces. The goal of the newly revised Salmonella and Campylobacter testing 

program is to protect the consumer from contaminated products by verifying that each 

establishment meets the new performance standards. Besides reporting individual Salmonella 

and Campylobacter sample results to establishments, FSIS posts nationwide Salmonella and 

Campylobacter data on its website on a quarterly basis. 

In this module, we will focus our discussion on the Salmonella and Campylobacter testing 

program for poultry products. 

Salmonella and Campylobacter Verification Testing – The Role of the Inspector 

The Salmonella and Campylobacter verification sampling is conducted in establishments by 

FSIS inspection program personnel (IPP). IPP will collect samples using ongoing scheduled 

sampling (routine sampling) employing a moving window approach to assess process control 

for all Salmonella and Campylobacter performance standards. 

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It is important for the IPP in establishments slaughtering or producing raw intact or raw nonintact chicken and turkey products to update the establishment’s Public Health Information 

System (PHIS) profile information as per FSIS Directive 5300.1, Revision 1 (2016). The 

Agency has made changes to the product group options in the PHIS establishment profile to 

identify establishments that produce specific types of raw intact and non-intact chicken and 

turkey products. 

Poultry Products Eligible for Sampling 

IPP will collect the following poultry samples, using a moving window sampling approach, to be 

analyzed for both Salmonella and Campylobacter as described in Directive 10,250.1, and 

supplemental documents, as well as through the “IPP Help” menu under FSIS Application. 

• Poultry carcasses 

– young chicken carcasses including broilers, fryers, roasters, and Cornish game 

hens, as described in 9CFR 381.170(a), and 

– young turkey carcasses 

• NRTE ground and other comminuted poultry sampling program 

NRTE comminuted poultry is any non-breaded, non-battered, raw NRTE chicken or 

turkey product that has been processed to reduce the particle size, which may or may 

not contain added ingredients. NRTE comminuted poultry includes: 

(1) ground (Ground product group category) – ground chicken or turkey for any 

purpose (e.g., packed for consumer or for any type of further processing); or 

(2) mechanically separated (Mechanically Separated product group) – mechanically 

separated chicken or turkey, as defined in 9 CFR 381.173; or 

(3) hand or mechanically deboned and further chopped, flaked, minced, or 

otherwise processed to reduce particle size. Chicken or turkey product, other 

than ground or mechanically separated falls under the “Other Comminuted” 

product group (sausage, patties, meatloaf, and other non-breaded and nonbattered comminuted products). These products include: 

– NRTE comminuted chicken product may be derived from any age chicken, 

including young chickens (broilers, fryers, and roasters), fowl, capons, and 

roosters, as defined in 9 CFR 381.170(a)(1); and 

– NRTE comminuted turkey product may be derived from any age turkey, 

including young turkeys, yearling turkeys, and old turkeys, as defined in 9 

CFR 381.170(a)(2). 

Note: These products include final (consumer-ready) products or intermediary product for 

further processing as NRTE product that are destined for sale as NRTE product for 

consumers. 

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Note: The Agency began collecting samples of young chickens carcasses produced under a 

religious exemption and not bearing the mark of inspection. In addition, FSIS will be testing for 

Salmonella and Campylobacter on young chicken/turkey carcasses, as well as poultry 

products, from establishments that produce less than 1,000 pounds per day. These samples 

are being collected under different sampling project codes. 

As explained in the January 2015 and February 2016 Federal Register Notices (Docket 

Number FSIS-2014-0023), FSIS began assessing whether establishments meet the pathogen 

reduction performance standards for Salmonella and Campylobacter in raw chicken parts. 

Furthermore, the Agency announced its plans to begin sampling additional raw chicken parts 

to gain additional information in the prevalence and the microbial characteristics of Salmonella 

and Campylobacter in those products (refer to the list of supplemental documents associated 

with Directive 10,250.1 and “IPP Help” menu under FSIS Applications). 

• Raw Chicken Parts Sampling Program: instructs IPP to collect raw chicken parts 

(finished product) to be analyzed for Salmonella and Campylobacter. Definitions are 

found in 9 CFR 381.170(b), Standards for kinds and classes, and for cuts of raw poultry. 

Eligible chicken parts for sample collection include: 

— Legs: whole legs (no backbone attached), drumsticks, thighs, and cut up or 

portioned leg meat (3/4 inch larger in at least one dimension), 

— Breasts: whole and half breasts (with or without ribs), boneless and skinless breasts, 

tenderloins and tenders, and cut up portioned breast meat (3/4 inch larger in at least 

one dimension), and 

— Wings: whole wings (with or without the wing tip), mixed wing sections, drummettes, 

mid-sections (flats), wing tips, and boneless wings 

Note: Chicken half carcasses and quarter carcasses are not eligible for collection under 

this sampling program. 

• Other Raw Chicken Parts Sampling Project (ORCPS): IPP will be collecting other raw 

chicken parts subject to sampling include hearts, whole or split gizzards, livers, necks, 

and quarter or half carcasses, together with both of those that are intact and those that 

are non-intact. These types of products will be analyzed for Salmonella and 

Campylobacter. 9 CFR 381.170(b) sets the requirements for specific cuts of poultry. 

This topic will not be discussed further in this module; refer to “IPP Help” menu under 

FSIS Applications – Raw Poultry Sampling Project Guidance for more information. 

Circumstances in Which Sampling is not Warranted 

When an establishment processes all its products into ready-to-eat (RTE) product or diverts all 

of its raw products (including NRTE comminuted poultry) to another federally inspected 

establishment for further processing into a RTE product, FSIS will exclude the establishment 

from the Salmonella verification-testing program schedule, according to FSIS Directive 

10,250.1 – Chapter VII. 

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For example, an establishment slaughters young chickens and produces NRTE ground 

chicken as one of its products. The establishment ships its entire ground chicken production to 

another establishment that uses it to make a RTE product. In this example, IPP would not 

sample the ground chicken. However, if other raw products were produced from the 

carcasses, then the chicken carcasses would still be eligible for Salmonella sampling. 

If an establishment states that the intended use of all product produced is RTE product, then 

IPP are to verify the intended use while performing the appropriate HACCP task. IPP are to 

verify, either by observing or by reviewing records, that the entire product is actually processed 

into RTE product in the establishment. 

If an establishment claims to move all products from a particular product class to another 

federally inspected establishment for further processing into RTE products, IPP are to verify 

this by reviewing the establishment’s HACCP plan and hazard analysis for the intended use of 

the products. In addition, IPP are to verify that the establishment has procedures incorporated 

in its food safety system that effect the movement of all products from that product class to 

another federally inspected establishment at which the product is further processed into RTE 

product. 

If the establishment cannot produce sufficient documentation to demonstrate the assertion that 

the product is further processed into RTE product, then the product is still eligible for sampling 

under the verification-testing program. 

If IPP verify that the product in question meets one of the exclusion criteria above, then IPP 

are to follow the additional instructions in FSIS Directive 10,250.1 – Chapter VII. 

When an establishment produces more than 1 lot of NRTE poultry product class (for example, 

ground chicken) and ships the product to different establishments that further process the 

poultry into RTE product, but one of the establishments produces NRTE products, the IPP are 

to sample product under the Salmonella verification testing program. In this situation, the IPP 

is not to differentiate between the products going to the establishments producing the RTE 

products versus the products going to the establishments producing the NRTE product when 

taking the sample. In addition, IPP are to follow additional instructions described in FSIS 

Directive 10,250.1 – Chapter VII, Section III. 

The Performance Standards 

The Salmonella and Campylobacter performance standards apply to the establishment’s 

overall process control, not to individual products. Products are not tested to determine their 

disposition, but rather to measure the effectiveness of the slaughter and grinding process in 

limiting contamination. Establishments do not have to hold product or recall product based on 

results of the Salmonella and Campylobacter samples. 

FSIS replaced its existing Salmonella sampling set-approach with a routine sampling approach 

for ALL FSIS-regulated products subject for Salmonella and Campylobacter verification 

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ing Window fo r Analysis of Testing Results 

A "window" is a timeframe. Each week the 52-week window moves up one week. 

Week of Jan 24, 2016 Week of Jan 22, 2017 

I I 52-week window I I 

Week of Jan 31, 2016 Week of Jan 29, 2017 

, -----J1-_ __,__ _______ s2_-_w_e_e_k_w_i_n_d_o_w ______ -'..._____, I I 

I I 

'------Week of Feb 6, 2016 Week of Feb 5, 2017 

____ __ [ ,_-~I _______ 52_-_w_e_e_k_w_i_n_d_o_w ________ __. I I I I 

r-----,i _____ ] I I L _____ J Week of Feb 13, 2016 Week of Feb 12, 2017 

52-week window 

I I 

I I 

____ J _____ : A new week's testing resu lts are added to 

: __________ j ~ the moving w indow analysis each week. 

:______ ~ The oldest week's testing results drop out. 

testing. This includes broiler and turkey carcasses, chicken parts, and NRTE comminuted 

poultry. Salmonella and Campylobacter performance standard verification samples are taken 

as part of a moving window and the results are used to determine if an establishment is 

meeting the performance standard on a continuous basis. When assessing process control 

under a moving window approach, FSIS intends to evaluate, over a certain period of time, a 

number of sequential results from a single establishment. Thus, given the fixed timeframe of 

one year (52 weeks) for which an establishment has been sampled, FSIS would assess the 

first moving window by evaluating the number of samples taken within the 52-week period. 

Subsequently, every week the 52-week period moves up one week adding a new week’s 

testing result and removing the oldest week’s results (refer to the “Moving Window for Analysis 

of Testing Results” diagram). 

Diagram-shows how the moving window works 

As an example, if an establishment has five Salmonella positives within 52 samples (one 

sample per week for a year), then the establishment passed the performance standard if the 

performance standard allows five positive samples among 52 samples. When the next sample 

is taken (week 53, in this example), the moving window would shift forward the fixed timeframe 

of one year (52 weeks); that is, the original week 1 (and the original first sample) is excluded, 

while the most recent week is included in the new 52-week moving window. This shifting is 

repeated with each new week and allows FSIS to continuously assess the process control of 

an establishment. 

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The chart below shows the maximum acceptable percent positive results or number of 

positives results allowed in the moving window before the establishment fails to meet the 

performance standard. In addition, FSIS will attempt to collect at least a minimum number of 

samples outlined in the chart below per year in order to assess process control in all 

establishments subject to the performance standards. A test is considered positive when any 

Salmonella or Campylobacter organisms are found. 

Salmonella/Campylobacter Performance Standards for Poultry 

Minimum # of 

Maximum Acceptable Samples to Product Performance % Positive Assess Proc. 

Standard Control 

Salmonell Campylo- Salmonel Campylo- Salmonell Campyloa bacter la bacter a bacter 

Broiler 9.8 15.7 

Carcass1 

Turkey 7.1 5.4 

Carcass1 

Comminute 25.0 1.9 

d 

Chicken2 

Comminute 13.5 1.9 

d 

Turkey2 

Chicken 15.4 7.7 

Parts3 

5 of 51 8 of 51 

4 of 56 3 of 56 

13 of 52 1 of 52 

7 of 52 1 of 52 

8 of 52 4 of 52 

11 10 

14 19 

10 52 

10 52 

10 13 

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1 The maximum acceptable percent positive for Salmonella and Campylobacter under the 

performance standards for young chicken and turkey carcasses is published in the FRN 

Docket No. FSIS 2014-0023 (2015). 

2 New performance standards published in the FRN Docket No. FSIS-2014-0023 (2016) using 

the larger 325 g analytical portion. 

3 New performance standards published in the FRN Docket No. FSIS-2014-0023 (2016) using 

the 4 lb. sample. 

Note: The new Salmonella performance standards are to be applied to sample results in place 

of the performance standards for young chickens (as broilers) and ground chicken and ground 

turkey codified in 9 CFR 381.94(b). 

For highest-volume establishments, FSIS expects to collect 52 samples within the 52-week 

moving window. In this case, to assess process control (at establishments producing products 

with performance standards measured in 52 samples), one need only to count the number of 

positives test results within the 52-week moving window. For example, the proposed 

performance standard for Salmonella in raw chicken parts is eight positives out of 52 samples. 

Assuming that 52 samples were collected from the establishment within a 52-week moving 

window, if the establishment has eight or fewer Salmonella positives within that 52-week 

timeframe, then it would pass the performance standard. If, on the other hand, the 

establishment has nine or more Salmonella positives within that same 52-week timeframe, 

then it would fail the performance standard. 

To assess process control in establishments that FSIS samples less often than weekly (i.e., 

lower volume establishments), FSIS will assess establishment performance (as percent 

positive) based on the number of samples collected and positive results within the 52-week 

moving window. To illustrate this point, if a small establishment producing raw chicken parts is 

sampled fewer than 52 times in the 52-week moving window, only 26 times, for example, with 

three of those samples testing positive for Salmonella, 26 will be the denominator while three 

be the numerator. This gives the establishment a percent positive of 11.5 ((3 ÷ 26) X 100 = 

11.5%). In this example, the resulting percent positive is less than 15.4, the acceptable percent 

positive for the performance standard for Salmonella in raw chicken parts. As such, the 

establishment would pass the performance standard. 

In conclusion, establishments fail to meet the standards when verification samples are found to 

exceed the maximum allowed percent positive during a 52-week analysis period (moving 

window). 

Sampling Procedure 

The purpose of the Salmonella and Campylobacter verification-sampling program is to verify 

the establishment’s process control for all applicable products. All eligible products produced 

at an establishment will be scheduled for sampling during the month under routine sampling. 

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For example, if an establishment produces more than one product type (chicken carcasses, 

chicken parts, and NRTE comminuted chicken) that is eligible for sampling, then all of those 

products will be scheduled for sampling during the month. 

If an establishment produces eligible product on more than one shift, IPP are to collect 

samples from different shifts for each sampling task so that all shifts are represented during 

routine sampling. IPP will collect a sample of product, using a random method, at an 

unannounced time for each sampling task, until enough samples have been taken and 

analyzed as part of the moving window. IPP are to collect samples in accordance with the 

step-by-step directions found in FSIS Directive 10,250.1 and supplemental documents, 

including applicable FSIS notices for all product classes including young chicken and turkey 

carcasses. Attachment 1 in this module gives an overview of the procedures for collecting 

samples as per FSIS Directive 10,250.1 (refer to the directive for detail instruction on how to 

collect the samples). 

Note: “Random” refers to the time the samples are selected, not to when the sponging or 

rinsing is initiated or completed. Random sampling may include the use of random number 

tables, drawing cards, or using computer generated random numbers. For example, the time 

entered for collection is when the carcass is removed from the line and the date is the day the 

carcass is sponged or rinsed. 

Salmonella and Campylobacter verification sampling is a directed sampling task. Taking into 

account risk factors including production volume and past establishment testing performance 

(i.e., positive Salmonella and Campylobacter test results), FSIS will establish the sampling 

frequency accordingly for a particular establishment. The Public Health Information System 

(PHIS) displays sampling tasks on the establishment task list for the sampling programs that 

apply to the establishment. The following are sampling project codes for the Salmonella 

sampling programs. Follow instructions outlined in the directive, supplemental documentations 

and guidelines. 

• The HC_CH_COM 01 (for chicken) and HC_TU_COM01 (for turkey) sampling codes 

correspond to products in the “Ground Product” and “Other Comminuted” product 

groups by randomly selecting from available eligible raw ground and other comminuted 

(but not mechanically separated) products. 

• The HC_CH_CARC01 and HC_TU_CARC01 sampling code corresponds to young 

chicken and turkey carcasses, respectively, to reflect the moving window approach. 

• The HC_CPT_LBW01 sampling code is used to collect samples at establishments 

producing chicken parts. 

IPP document the completion of the sampling task in PHIS including completing the 

questionnaire. IPP schedule verification-sampling tasks following the instructions in FSIS 

Directive 13,000.1 and perform the sampling tasks following the instructions in FSIS Directive 

13,000.2. 

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Sampling Method 

The specific sampling methodologies for the product classes to be sampled are explained in 

detail in FSIS Directive 10,250.1, supplemental documents and applicable FSIS notices. 

IPP collect samples using a carcass sponge swab, a whole bird rinse, or taking a specific 

amount of ground/comminuted product using the sampling technique as described in FSIS 

Directive 10,250.1, supplemental documents and guidelines, including published FSIS notices. 

Turkey carcasses are sampled using a sponge sample technique. Sponge sampling of turkey 

carcasses uses two sponges, one that is analyzed for Salmonella and the other for 

Campylobacter. Sponge sample sites are to the left and right of the back and thigh as per 

instructions delineated in the directive. 

Chicken carcasses are sampled using whole bird rinses; IPP are to collect 100 ml of rinsate. 

Note: For poultry carcasses, at the post-chill sampling location, IPP are to determine a random 

time at which the carcass will reach the end of the drip line or the equivalent point in air-chill 

systems. IPP are to randomly select a poultry carcass from the post-chill area (after all 

interventions have taken place) and to allow drip time to prevent dilution of the sample. 

Chicken parts are sampled by collecting approximately 120 ml of rinsate from 4 lbs. ± 10% of 

the eligible raw chicken parts. 

The amount of ground product collected (final package or aseptically when not in final 

package) by the IPP under the appropriate sampling project code is as follows: 

• NRTE comminuted poultry products are sampled by collecting sufficient product to fill 

the two provided Whirl-Pak bags up to the fill-line indicated on each bag, following the 

instructions as described in the “IPP Help” menu (FSIS Applications) - Raw Poultry 

Sampling Project Guidance. The total weight of the two bags of samples should be 

approximately two pounds. This larger sample size will provide consistency as the 

Agency moves toward analyzing each sample for both pathogens. 

In establishments that produce more than one type of product subject to testing, all eligible 

products produced will be scheduled for sampling during the month under routine sampling. 

Additional Sampling Directions 

The Inspector-in-Charge (IIC) at establishments subject to Salmonella and Campylobacter 

verification testing should ensure that adequate sampling supplies are available prior to the 

start of each sampling task. 

IPP are to notify official establishment management just before collecting a routine Salmonella 

or Campylobacter sample. 

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IPP are to schedule the directed sampling tasks on the task calendar (refer to Sample 

Management Module, section “Scheduling and Submitting a Directed Lab Sample”) and collect 

a sample the day the product class is produced. 

Once the IPP has scheduled the sampling task with the laboratory assignment, using the PHIS 

Laboratory Capacity Reservation System in the Task Calendar, then the IPP can proceed to 

collect the sample. The IPP may choose to print a draft copy of the “Sample Analysis Request” 

form to use as a reference during sample collection and to document product information (refer 

to Attachment 2 at the end of this module). Some information is already pre-printed in the 

Collection and Animal Information data fields of the sampling form, such as sample form ID, 

project code, and sample source. 

Note: When entering information into PHIS for carcass-based Salmonella or Campylobacter 

sample collection (chicken whole bird rinses or turkey carcass swabs), IPP are to enter “N/A” 

(for Not Applicable) into all “Sample Management-Sample Collection” required data entry fields 

related to the producer name and address. Samples should not be frozen and should be kept 

secure at all times. Sample boxes should never be stored near heaters or areas exposed to 

excessive heat. Cool the shipping container the day before collecting the sample. The 

laboratory will discard rinse samples that arrive above 50°F or below 32°F. It is critical that 

refrigerated sample temperature is maintained during collection and shipment. 

When a sample is collected, IPP are to enter the data requested in the data fields (as indicated 

above) on the sampling form, submit the sample form through PHIS, print and sign the form, 

pack and ship the sample as described in PHIS Directive 13,000.2 and the Sample 

Management module of this training. Be careful to send the sample to the appropriate 

laboratory as identified on the sample form; otherwise, it will be discarded. The lab analyzes 

the samples and the Office of Planning, Analysis and Risk Management (OPARM) tracks the 

data and results. IPP receive laboratory-testing results when they are posted in LIMS-Direct 

and in the establishment’s home page in PHIS for both pathogens. IPP receive an alert on the 

PHIS Inspector home page when an FSIS sample result is positive. 

Defining Categories 

If the sample under the routine Salmonella verification sampling meets the Salmonella and 

Campylobacter performance standards (i.e., the maximum acceptable percent positive allowed 

under the moving window approach), it passes. If the sample results in the moving window 

exceed the maximum percent positive allowed, the establishment has not met the performance 

standard. 

FSIS uses categories in evaluating an establishment’s level of process control and for 

scheduling Salmonella and Campylobacter performance standard verification testing. For all 

products sampled under routine Salmonella verification sampling, FSIS has recently modified 

its process control category classification system as follows: 

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Category 1 – Consistent Process Control: Establishments that have achieved 50 

percent or less of the maximum allowable percent positive during the most recent 

completed 52-week moving window. 

Category 2 – Variable Process Control: Establishments that meet the maximum 

allowable percent positive but have results greater than 50 percent of the maximum 

allowable percent positive during the most recent completed 52-week moving window. 

Category 3 – Highly Variable Process Control: Establishments that have exceeded the 

maximum allowable percent positive during the most recent completed 52-week moving 

window. 

Note: FSIS is not currently assessing the Campylobacter performance standards because 

is in the process of revising the performance standards in raw poultry products. The agency 

will not be taking any further action concerning to the sampling results until the new 

Campylobacter performance standards are in place. 

Note: OPARM handles the data analysis and reporting; it also determines the official 

establishment category. 

Agency’s Actions 

As per recently published instructions (FSIS Notices 18-18 and 32-18), when an establishment 

is assigned to Category 2 or 3, IPP are to do the following: 

• For Category 2 – IPP and supervisors will receive an alert entitled, “Warning: Product 

Exceed One Half of Performance Standard”, through the PHIS dashboard. During the 

next weekly meeting, IPP will discuss with plant management that the results indicate 

variable control of Salmonella, as well as advise the establishment to make changes to 

avoid failing the performance standard; document the discussion in an MOI following 

instructions, as per published policy (Notice 18-18). 

• For Category 3 – IPP and supervisors will receive an alert entitled, “Failure to Meet a 

Salmonella Performance Standard”, through the PHIS dashboard. During the next 

weekly meeting, IPP will discuss with plant management the failure to meet the 

Salmonella performance standard and that FSIS will be collecting follow-up samples; 

document in an MOI (Notice 32-18). In addition, IPP are to determine if: 

— corrective actions have been identified and implemented as written, as per 9 

CFR 417.3 

— establishment has reassessed its HACCP system and modified its HACCP plan, 

including supporting documentation (417.3(b) and 381.65(g)) 

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FSIS will conduct follow-up samples and will only be scheduled for those raw poultry products 

subject to Salmonella performance standards (i.e., the number of positive samples within a 

specified timeframe exceeds the maximum acceptable for that product class); these 

aforementioned samples will be analyzed for both Salmonella and Campylobacter, where 

applicable (Notice 11-18). 

IPP will receive a “New Follow-up Sampling Task” alert through the PHIS dashboard 

approximately 30 days after the Category 3 alert. 

The follow-up samples will be assigned for raw poultry carcasses, chicken parts, and NRTE 

comminuted poultry products under the project codes below. 

F_CH_CARC01 (for young chicken carcasses) 

F_TU_CARC01 (for young turkey carcasses) 

F_CPT_LBW01 (for raw chicken parts) 

F_CH_COM01 (for NRTE comminuted chicken product) 

F_TU_COM01 (for NRTE comminuted turkey product) 

Note: At this time, FSIS will not implement follow-up sampling in establishments that do not 

meet the Campylobacter performance standard in raw chicken parts or NRTE comminuted 

poultry products. 

Specifically, either 16 or eight follow-up samples will be collected depending on the size and 

production volume of the establishment. IPP are to collect one follow-up sample per shift 

(when possible) as instructed in Notice 11-18. The Agency will analyze the follow-up sampling; 

FSIS will no longer include follow-up sampling results as part of the moving window when 

determining establishment category status. 

IPP are to consider whether the overall pattern of inspection findings indicate a systemic 

problem with the establishment’s HACCP system, or whether the establishment is slaughtering 

and/or processing poultry under insanitary conditions. IPP are to bring such concerns to their 

FLS to evaluate the need to take further enforcement action. 

SAMPLING RTE PRODUCT 

Objectives 

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

1. Identify the pathogens of concern associated with sampling of ready-to-eat (RTE) product. 

2. Describe the conditions for RTE product to be considered adulterated. 

3. Define the following terms: 

a. Food contact surface 

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b. Intact package 

c. Sampled lot 

4. Describe the steps for performing a RTE sampling task. 

5. Explain the difference between the RTEPROD_RAND and the RTEPROD_RISK sampling 

project codes. 

6. Describe why it is important to notify establishment management prior taking a sample. 

7. Identify how IPP obtain sample results. 

8. Describe what actions IPP take when a positive FSIS RTE sample result is identified. 

9. Describe the actions IPP take when establishment testing obtains a positive sample result. 

10. Explain the procedures in verifying corrective actions for a positive RTE sample. 

Introduction 

FSIS’s microbiological testing program is designed to verify that the establishment’s food 

safety system is effective and that FSIS performance standards and regulations are met. FSIS 

tests RTE products for pathogens because of the potential public health impact of a 

breakdown in the establishment’s food safety system. The pathogens of public health concern 

in RTE products are Listeria monocytogenes (Lm) and Salmonella. Therefore, RTE product 

samples are tested for both of these organisms by FSIS laboratories. Salmonella is generally 

associated with under-processing or cross-contamination post-processing while Lm is more 

often associated with cross-contamination post-processing. RTE product is adulterated if it 

contains Lm, Salmonella, or any pathogen known to cause illness including E. coli O157:H7, or 

if it comes into direct contact with a food contact surface contaminated with Lm. 

Note that FSIS is continuously updating its sampling programs in order to keep pace with 

changes in policy. FSIS directives and notices for current sampling programs contain specific 

instructions to follow. It is important to read recent issuances, so that when you are 

requested to collect a sample you have the latest information. See Attachment 1 for a list 

of relevant FSIS Directives. 

Definitions 

Aseptic means, “free from pathogenic organisms.” Aseptic technique implies that IPP do not 

add any organisms (pathogenic or not) to the sample when it is collected. It does not imply that 

the sample is aseptic. The purpose of aseptically collecting a sample is to prevent 

contaminating the sample or the surrounding product/product contact area. That is why it is 

important to aseptically collect a sample even when the sample is intact. IPP should wash and 

sanitize their hands before collecting an intact sample, but it is not necessary to sanitize the 

area and put on gloves. Good personal hygiene is essential anytime a sample is collected, 

whether intact or not. 

Environmental samples are samples from surfaces that have: 

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 Indirect or potential contact with exposed RTE product in the RTE production area 

(mop handles, outer garments, etc., that may be handled by a person who may 

touch RTE product), or 

 Non-contact surfaces in a RTE production area (e.g., floors, drains, walls, overhead 

structures). 

Food contact surface is specific to the RTE verification testing program. A food contact 

surface is the equipment or utensil surface with which exposed RTE product has direct contact 

(for example, conveyor belt, tabletop, knife blade). A food contact surface does not include 

items that may have indirect or potential contact with exposed RTE product. 

Food contact surface samples are a collection of samples (e.g., swabs) from food contact 

surfaces that represent the conditions under which the sampled lot was processed. The 

samples are usually collected during the production shift, not pre-operational, but without 

disrupting production, such as during breaks and at the end of a shift. 

Intact means product in the final packaged form (immediate container) in which it will be 

shipped. The lab receives the sample in the same immediate container as intended for the 

consumer. 

Recall is an establishment’s voluntary removal of distributed meat or poultry products from 

commerce when there is reason to believe that such products are adulterated or misbranded 

under the provisions of the Federal Meat Inspection Act (FMIA) or the Poultry Products 

Inspection Act (PPIA). Product that is adulterated and has left the establishment’s control may 

be subject to a recall. The recall would involve at least the sampled lot, but it could be 

expanded depending upon a review by the Recall Management Division (RMD) of all factors in 

the situation. FSIS Directive 8080.1 gives additional details on recalls. 

RTE production area is one where exposed RTE products are stored, further processed, or 

packaged. This is the area from which food contact surface samples and environmental 

samples are taken and analyzed for Lm or indicator organisms. 

Sample is a collection of product that represents a larger group of product (i.e., the sampled 

lot). 

Sampled lot is the amount of product represented by the sample. For microbial issues, the 

actual (affected) product represented by the sample is usually interpreted as the product 

produced from clean-up to clean-up. Often, factors like the establishment’s coding system, the 

pathogen of concern, the processing and packaging, the equipment, the establishment’s 

sampling programs, the HACCP plan monitoring and verification activities, the SSOP records, 

etc., are considered when determining how much product is actually represented by the 

sample. 

Short-weight or slack-filled containers meet the definition of an intact sample, but with less 

product (e.g., a liner from a bulk package which contains approximately 2-lb of product, folded 

down and sealed in the same manner that the bulk product is normally packed to prevent 

product contamination). A short-weight or slack-filled sample is one that has progressed 

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through all the production steps that the product normally goes through (not changed in any 

way that would affect the processing parameters). A short-weight or slack-filled sample may 

appear to the lab as a non-intact sample and may be discarded if PHIS information does not 

indicate it is short-weight or slack-filled. 

Subsequent production is all product produced after the sampled lot. It is not usually part of 

the sampled lot, but it may or may not be affected product. 

Sample Initiation 

PHIS will display any RTE sampling tasks on the Task List based on the sampling programs 

for which the establishment is eligible. These PHIS generated requests are called “directed” 

sampling tasks. There are no “collector generated” sample requests for RTE product sampling. 

However, if IPP have concerns about the product or process they may follow their supervisory 

chain of command to request additional “directed” samples. IPP are to provide information on 

the type of sample to be collected and a justification for the sample collection request. If 

additional sampling is justified, the district office will contact DAIG to request that the tasks be 

generated through PHIS as a directed sample task. Once the additional directed sampling 

tasks appear on the establishment’s task list, IPP may then schedule them. 

Steps in Sampling 

There are 6 general steps in sampling RTE product. 

o Determine which product to sample and schedule the sample 

o Notify establishment management 

o Collect the sample 

o Document the Sample 

o Pack and ship the sample and form 

o Respond to the results 

Step 1: Determine which product to sample and schedule the sample 

IPP collect RTE product samples under the following project codes: 

RTEPROD_RAND: For this sample program, IPP will randomly select any RTE product 

produced at the time of collection, regardless of whether the product has been exposed postlethality; and make every effort to randomly sample all the RTE products produced at the 

establishment by rotating through the products over time (i.e., through subsequent sample 

requests). 

RTEPROD_RISK: For this sample program, IPP are to select a post-lethality-exposed product 

from the highest risk level, according to the table below. 

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P Processing Finished Product Production Volume Categories Risk 

Cateqories Cateqories (by Product Groups) Level 

Other Fully Cooked Sliced 1 Product 

Hot Doq Products 2 

RTE fully-cooked meat Salad/Spread/Pate 3 

Fully Cooked-Not Shelf (PLE)1/ RTE fulty-cooked Diced/Shredded 4 

Stable poultry (PLE) Meat+ Nonmeat Components 5 

Sausaoe Products 6 

Patties/Nuggets 7 

Other Fully Cooked Not Sliced 8 Product 

RTE acidified/fermented RTE fermented meat (sliced or 

meat (without cooking}- not sliced)/ RTE fermented 

PUE/ RTE poultry (sliced or not sliced) 9 

Not Heat Treated-Shelf 

acidified/fermented poultry (Acidified/Fermented 

(without cookino)-PLE Productsi2 

Stable/Heat Treated-Shelf RTE dried meat (sliced or not 

Stable RTE dried meat (PLE)/ sliced)/RTE dried poultry 

RTE dried poultry (PLE) (sliced or not sliced) 10 

(Dried Products) 2 

RTE salt-cured meat RTE salt-cured meat (sliced or 

(PLE)/ RTE salt cured not sliced)/ RTE salt-cured 11 

poultry (sliced or not sliced) poultry (PLE) (Salt-cured Products) 2 

Product wrth Secondary RTE salt-cured meat RTE salt-cured meat (sliced or 

Inhibitors - Not Shelf (PLE)/ RTE salt cured not sliced)/ RTE salt-cured 11 Stable poultry (sliced or not sliced) poultry (PLE) (Salt-cured Products) 2 

'I Post-lethality exposed product 2 Product type to be used on Form 10,210-3. 

Exceptions: Do not collect samples of oils, shortening, lard, margarine, oleomargarine, or 

mixtures of rendered animal fats that are Ready-to-Eat (RTE) because there is no validated 

test method for detecting Lm in these products. 

FSIS will sample popped pork skins, pork rinds, dried soup bases, concentrated (high salt 

content) soup mixes, and pickled pig’s feet under both programs. FSIS will collect samples of 

RTE products that are shipped hot from the establishment. 

When IPP receive an RTEPROD_RAND or RTEPROD_RISK request in PHIS, they are to 

schedule an RTE product sample within the sampling window timeframes given. IPP are to 

randomly select a day, shift, and time within the sample window timeframe. There should be 

an equal chance that sampling will occur during any shift where eligible product is produced. 

IPP should not wait until the end of the sampling window to schedule the sample. Scheduling 

the sample at the beginning of the sampling window will allow more time to ensure that a 

sample is available during that timeframe. 

Step 2: Notify Establishment Management 

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Before collecting a sample, IPP are to officially notify the establishment management that they 

will be collecting a sample and to explain the reason that they are collecting the sample. 

When notifying the establishment that FSIS will collect a sample, IPP are to confirm that the 

establishment will be producing post-lethality exposed RTE product (RTEPROD_RISK) or RTE 

product (RTEPROD_RAND) on the day sampling is scheduled. In addition, IPP are to confirm 

that the establishment is planning to implement its documented routine production, Sanitation 

SOP, and food-safety practices on the day the sample is scheduled. 

IPP are to generally provide a one day advance notice if that is sufficient for the establishment 

to hold the sampled lot but not to change practices. IPP may provide more advance notice if 

the establishment can support that more time is necessary because of the innate 

characteristics of the process. IPP should inform the establishment that, if it changes routine 

practices without justification for doing so, FSIS may provide it with less than a one day notice 

if that is sufficient to hold the sampled lot. If IPP have questions about an establishment’s basis 

for requesting more notice, they are to submit them through askFSIS. 

IPP should inform the establishment that, if it intends to modify its documented routine 

production, sanitation, or food-safety practices before the sampling, it should inform IPP as 

soon as possible so that sampling can be rescheduled. If the establishment continues to 

change routine practices and cannot support the changes, less than one day advance notice 

may be provided, or an FSA may be scheduled at the establishment. 

NOTE: Justifiable reasons for changing practices may include limiting the lot size to facilitate 

holding the product, changes in customer orders, or documented changes to Sanitation SOPs 

or HACCP plans. 

IPP should inform the establishment that it is responsible for supporting its basis for defining 

the product represented by the sample (i.e., the sampled lot); and inform the establishment 

that it is required to hold or control the sampled lot until negative results are received. IPP will 

verify that the establishment is holding or controlling the product represented by the sampled 

lot (the product produced from clean-up to clean-up) and record the information in PHIS. 

Immediately contact the DO if the establishment does not hold or maintain control the sampled 

lot. 

Step 3: Collect the Sample 

IPP will collect the sample from the current day’s production after the establishment has 

applied all interventions except any microbiological testing intervention. If the establishment 

intends to test the product for Lm or Salmonella, IPP are not to wait for the establishment to 

receive the test results. 

For both RTEPROD_RAND and RTEPROD_RISK samples, IPP are to collect a two-pound 

sample of product in an intact package. Collecting products in the intact package will help to 

ensure that the product does not become contaminated with Lm from the environment during 

the sample collection process. If packages weigh less than two pounds, IPP are to collect 

enough packages to bring the total to a minimum of two pounds. 

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IPP are to collect the product at least three hours after the start of production (if possible), to 

allow Lm to work its way out of the equipment. If the establishment’s production lot is typically 

less than three hours, IPP may collect the samples during the production shift. IPP are to vary 

the shifts in which they collect samples, if possible. 

If the establishment produces reworked product, IPP are to sample the product as part of the 

production lot, as long as IPP provide the establishment with adequate notice to hold the 

sample. Rework is the process of re-cooking, reprocessing, or repackaging the product. FSIS 

considers any process that removes the product from the package and exposes it to the 

environment as rework. 

If the finished product contains meat or poultry and non-meat or non-poultry ingredients, IPP 

are to follow the instructions below. 

• If the meat or poultry and non-meat or poultry ingredients are commingled (in contact) in 

the final package (e.g., a salad with meat or poultry mixed in), IPP are to collect a twopound sample of the complete product (including the meat or poultry and nonmeat or 

poultry component). 

• If the meat and nonmeat ingredients are not commingled (not in contact) in the final 

package (e.g., an entree with separate compartments for meat or poultry and 

vegetables), then IPP are to collect a two-pound sample of the meat or poultry 

component in the final package. 

IPP are to submit the samples to the laboratory for microbiological analysis in intact packages. 

The laboratory does not supply sterile bags or gloves for sampling because IPP are not to 

have direct contact with the exposed, unpackaged RTE product. This is because Listeria may 

be present in the environment and could be transferred to the product if exposed RTE product 

is collected. 

If an intact product or product container is too large, heavy, or costly to ship to the laboratory, 

IPP can ask the establishment to slack-fill or short-weight a product for a 2-pound sample and 

send it in the usual establishment packaging such as the container liner. 

If the slack-filled or intact package is an unsealed bag, IPP are to tie it off (e.g., twist tie or 

rubber band) so smaller particles (e.g., shredded meat pieces) do not spill into the shipping 

container. IPP are to place the slack-filled package in a secondary bag. The laboratory will 

discard the sample if it contains spilled or leaking products. When IPP document the sampling 

task in PHIS, under the “Additional Info” tab, they are to click “yes” to the question “Is this 

sample short-weighted/slack-filled?” to ensure that the sample is not discarded as a non-intact 

sample by the laboratory. 

IPP are not to use any laboratory-supplied bag as the primary wrap for the sample. Laboratory 

supplied bags provided by the laboratory are for secondary containment only because they are 

not sterile. The laboratory-supplied bag protects the box in case the primary container leaks. 

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If IPP cannot collect an intact short-weighted or slack-filled sample, and the establishment is 

not producing any other type of RTE product that the IPP could collect, IPP are to contact the 

designated laboratory to discuss other options for collecting the sample. 

NOTE: Examples of inappropriate samples for short-weight or slack-filled samples include a 

sample that would have to be cut to fit inside the shipping container, and samples that are 

packed in a waxed box without a liner bag that is too large to fit inside a laboratory shipping 

box. 

When a sample cannot be collected on the date originally scheduled, inspectors should follow 

instructions specific to rescheduling lab sampling tasks in PHIS. When sample collection 

cannot be rescheduled for any date within the requested time frame, IPP should cancel the 

sample request within PHIS and provide a justification as to why the sampling could not be 

performed. 

Intervention Considerations 

If the establishment treats the product with an intervention (e.g., HPP), either at the 

establishment or at another establishment, IPP are to review documentation the establishment 

keeps as part of its HACCP program to determine the purpose of the treatment. 

If the HPP is applied as a Listeria intervention, and the establishment has supporting 

documentation demonstrating that the treatment achieves at least a 1-log reduction of Lm, IPP 

are to collect the sample after the treatment is applied. If the product is not returned to the 

producing establishment after the HPP treatment, IPP are to sample another product, if 

possible. The product, in this case, would be subject to sampling at the HPP facility if records 

show that the treatment was applied as a Listeria intervention. If the establishment is not 

producing any other RTE product at the time the sampling is scheduled, IPP are to cancel the 

task and enter into PHIS “all interventions have not been applied at this establishment.” 

NOTE: If the establishment’s validation supports that the HPP treatment achieves at least a 5-

log reduction of Lm, the product is not considered post-lethality exposed and would only be 

sampled under the RTEPROD_RAND project code. 

If the treatment is applied to extend the shelf life of the product, and the establishment does 

not have supporting documentation describing the treatment as a Listeria intervention, then 

IPP are to collect the product before the treatment. The product would not be subject to 

sampling at the HPP facility, as long as it has records on file supporting that the treatment was 

applied to extend the shelf life. 

Altered Practices 

On the day of sample collection, if IPP find that the establishment has altered its documented 

routine production, sanitation, or food-safety practices, and the establishment cannot provide a 

supportable rationale, IPP are not to perform sampling and are to reschedule if possible. 

IPP are to issue an NR under the following circumstances: 

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• If IPP find that the establishment has made changes in its food safety systems (e.g., 

temporarily changing its supplier of RTE product on the day the sample is collected) and 

does not have documents supporting the appropriateness of the change, IPP are to 

issue an NR. The NR would be issued because the establishment did not consider the 

changes in its hazard analysis in accordance with 9 CFR 417.2(a) (1), or did not support 

the changes to its hazard analysis as in 9 CFR 417.5(a) (1). 

• Likewise, if IPP find that the establishment has made changes in its sanitation practices 

(e.g., temporarily increasing the use of sanitizer only on the day the sampling is 

scheduled) and did not revise its Sanitation SOP to reflect these changes, IPP are to 

issue an NR under 9 CFR 416.14. 

NOTE: If an establishment decides to limit its product lot size solely to facilitate holding the 

product during sampling, it would not be considered to have significantly altered its production 

practices, as long as IPP can collect samples that accurately represent routine production. If 

IPP have questions about whether an establishment is altering routine production, sanitation, 

or food-safety practices, they can submit them through askFSIS. 

At the next weekly meeting, IPP are to discuss the altered food safety practices with the 

establishment. Inform the establishment that if it continues to change its practices, FSIS may 

collect more samples and may give less than 1 day notice (if less time is enough to hold the 

sampled lot) or schedule a “for-cause” FSA. 

Step 4: Document the Sample in PHIS 

On the day of sample collection, IPP will enter sample collection data and additional product 

info in PHIS as directed in PHIS Directive 13,000.2. IPP are to complete a questionnaire in 

PHIS for each RTEPROD sample request and are to ensure that all requested information is 

entered completely and accurately. 

IPP must answer the questionnaire in PHIS before submitting the sample. The questionnaire 

includes: 

1. Selection of the appropriate RTE product type. 

2. Amount of pounds represented in the sample. This is based on what the establishment 

declared the sample lot to be. 

3. Is the product post lethality exposed? If yes then the IPP must answer 3a, which asks 

for the Alternative the product was processed under. If no then PHIS will forward to 

question 4. 

4. Identify the production line the sample was taken from. If the establishment has only 

one line mark N/A. 

5. Enter the time the collection was made in military format. 

6. Enter the contact person for the establishment. 

7. Enter the contact phone number for the contact. 

8. Answer yes or no, whether establishment management was notified of this sample 

collection. 

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9. Indicate if the sample was short weighted or slack filled. This will prevent the laboratory 

from discarding the sample because it is not in the final retail package. 

10.Answer where the sampled lot is being held or controlled. 

When IPP are certain that the correct information has been entered in PHIS, they must submit 

both the questionnaire and the Sample Analysis Request Form electronically to the laboratory. 

Then IPP will print and sign the form and include it with the sample in the sample shipment 

container. If the lab receives a sample with missing or incomplete paperwork the sample will 

be discarded. 

Step 5: Pack and Ship the Sample and Form 

Identify the sample and paperwork, and place them into the bag provided by the lab. 

Double check and compare the address on the FedEx expanded billable stamp to make sure it 

is going to the lab indicated in PHIS and on the Sample Analysis Request Form. The lab will 

discard the sample if shipped to the wrong lab. Also be sure to check the expiration date on 

the expanded billable stamp. Do not use an expired expanded billable stamp. 

IPP are to safeguard the integrity of samples during submission according to FSIS Directive 

7355.1, Use of Sample Seals for Laboratory Samples and Other Applications. Place one of the 

small bar code stickers from the 7 part sample seal set (7355-2A/B) on the sample package, 

and another on the Sample Analysis Request Form. Put the Sample Analysis Request Form in 

a plastic bag or sleeve to protect it. Put the sample and the form into a zip-lock bag, and attach 

the Identification Label, 7355-2B, to the zip-lock bag so that the bar code is readable. 

Pack the sample. Samples should be shipped in FSIS-furnished containers, unless special 

arrangements are made with the lab. Pack one sample per pre-chilled shipping container to 

avoid confusion. Multiple samples can be sent in one container, as long as each sample is 

accompanied by its sample form and there are no concerns over maintaining product 

temperature. In cases where multiple product packages are necessary for a single sample, all 

of them must be shipped in the same shipment container. Pack the sample in this order. 

1. Absorbent pad 

2. Gel pack 

3. Cardboard separator 

4. Zip-lock bag containing the identified sample and paperwork 

5. Extra small bar code sticker that was not used 

6. Foam plug 

7. Close shipper with Container Seal (7355-2A) 

NOTE: The shipping containers should have the top and bottom sealed by the lab with tamperevident tape. IPP will not receive any tamper-evident tape to use. If the tape is cut or missing, 

do not open the container. Follow the instructions in FSIS Directive 7355.1 (seal it with the 

Container Seal, 7355-2A, and ship it back to the lab of origin for processing; complete the seal 

by writing “seal broken” in the “Form No.” blank). 

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The absorbent pad is placed in the bottom of the shipping container. Its purpose is to absorb 

any fluid that may leak into the box in order to maintain the integrity of the shipping container 

for future use. A frozen freeze pack must be added for product that was stored refrigerated or 

frozen. The cardboard separator goes on top of the freeze pack to separate the freeze pack 

from the sample. The bagged sample is then put into the shipper. Do not use filler material in 

the shipping container. Any unused bar code sticker needs to go into the shipper with the 

sample. This insures that it won’t accidentally get used on another sample, and allows the lab 

to account for all 7 parts of the seal/label. Alternatively, the unused bar code may be retained 

with the file record of sample collection. The foam plug must be pushed down as far as 

possible to keep the sample from being tumbled inside the shipper. 

An FSIS Laboratory Sample Container Seal (FSIS Form 7355-2A) must be put on the shipping 

container in such a way that it cannot be opened without disturbing the seal. 

Ship the sample. IPP are to ship samples Monday through Friday so that they arrive at the 

laboratory overnight. IPP are not to ship samples on Saturdays or on the day before a Federal 

holiday, or as directed by a user notice via e-mail. 

Step 6: Respond to Results 

IPP will access LIMS-Direct to track sample receipt and for detailed information on FSIS 

sample results or discards. LIMS stands for Laboratory Information Management System. 

LIMS-Direct is a program that reports FSIS lab sample results directly from LIMS. It will provide 

close to real-time sample data electronically to FSIS program personnel, Federal, and State 

establishments (via email), and State officials, if FSIS laboratories conduct testing for States. 

LIMS-Direct will be updated every 15 minutes and display sample data history longer than the 

last 90 days of data. If, in limited cases, LIMS does not receive an electronic record from the 

Public Health Information System (PHIS) because of technical reasons, sample results will still 

be available in LIMS-Direct. 

When IPP go to the LIMS-Direct address, several options are available. 

1. Single Sample Results – search using the form number. 

2. Single Establishment Results – search using the establishment number to obtain all the 

results in the database for that establishment. 

3. Results for All Establishments in a Circuit – search by entering the circuit number. 

4. Results for State Inspection Sample – search using the state code. 

5. Samples Not Analyzed for All Establishments in a Circuit – search using the circuit 

number. 

6. More Reports – search for more types of reports that are available. 

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Option 3 is particularly useful if it is a patrol assignment, since one can see the status of the 

samples of all the establishments at one time. 

Once the analyses are complete, the results are posted in the results column. 

IPP should provide sample result information to establishment management even if the 

establishment receives e-mail notifications automatically. 

Sampling Project Positive Results 

If any RTE product sample collected by IPP under the RTEPROD_RAND or RTEPROD_RISK 

sampling projects tests positive for Lm or Salmonella, product in the sampled lot is adulterated. 

IPP are to follow the instructions in FSIS PHIS Directive 5000.1 when taking enforcement 

actions in response to positive sampling results. In addition, IPP are to consider the following: 

• If FSIS finds the product positive, and the establishment tested the product under its 

documented sampling programs, IPP are to check the establishment’s Salmonella or 

Lm testing results to determine whether the establishment also found the sampled 

product to be positive for Salmonella or Lm. 

• IPP are to determine whether the establishment held the product or maintained control 

of the product pending its own test results. 

• If IPP find that the establishment did not hold or maintain control of the product, they are 

to issue an NR. The NR would be warranted because the establishment shipped 

product before FSIS found that the product was not adulterated, and because the 

establishment did not complete pre-shipment review following availability of all relevant 

test results, as set out in 9 CFR417.5(c). 

Generally, if FSIS finds the product positive for Salmonella or Lm, IPP are to issue an NR (cite 

9 CFR 417.4(a)). However, if the establishment also found the product to be positive for 

Salmonella or Lm and held the product, IPP are not to issue an NR. They are to verify that the 

establishment performs the appropriate corrective actions, using a directed HACCP 

Verification Task. 

Establishment Sampling Program Positive Results 

Establishments under Alternative 2 Choice 2 and Alternative 3 are required to conduct 

sampling of food contact surfaces. Establishments may also choose to conduct sampling of 

product. If an establishment’s product or food contact surface test result is positive for Lm, IPP 

should not issue an NR unless the establishment failed to hold the affected product and did 

not implement corrective actions, which includes properly disposing of the sampled product lot. 

An establishment may or may not conduct environmental sampling, other than on food contact 

surfaces, under its HACCP plan or Sanitation SOPs or other prerequisite program. If the 

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establishment is conducting such sampling, and positive results are received, IPP are to verify 

that the establishment takes the appropriate action as outlined in the program under which the 

establishment did the sampling. If the establishment is conducting such sampling but is not 

addressing the sampling under HACCP or Sanitation SOPs or other prerequisite programs, 

and IPP find that such sampling is resulting in repetitive positive results, IPP are to notify the 

district office through supervisory channels. 

Verifying Corrective Actions 

If FSIS finds a product or food contact surface positive for Lm or Salmonella, IPP are to verify 

that the establishment takes the appropriate corrective actions by performing a directed 

HACCP Verification Task. 

When performing a directed HACCP Verification Task in response to a Lm positive result, IPP 

are to review the same information they review during a routine HACCP Verification Task. IPP 

are also to verify that the establishment implemented corrective actions according to 9 CFR 

417.3 (a) and (b) if the measures for addressing Lm are included in the HACCP plan or 

prerequisite program, or 9 CFR 416.15 if the measures are incorporated in the Sanitation SOP. 

FSIS will also perform an IVT/FSA for Lm, as described in FSIS Directive 10,300.1. 

When performing a directed HACCP Verification Task in response to a Salmonella positive 

result, IPP are to verify that the establishment took the appropriate corrective actions 

according to 9 CFR 417.3(a) or (b), or 9 CFR 416.15. Although the regulations do not require 

establishments to specifically control for Salmonella in post-lethality exposed RTE products, as 

stated previously, FSIS considers RTE products to be adulterated if products or food contact 

surfaces test positive for Salmonella or other pathogens. Therefore, establishments are 

required to take corrective actions in response to positive results and to reassess their HACCP 

plan. FSIS will perform an IVT/FSA for Salmonella, as described in FSIS Directive 10,300.1. 

In addition, if FSIS develops a verification plan in response to an establishment’s proffered 

corrective actions and preventive measures when enforcement is deferred following the 

issuance of a Notice of Intended Enforcement (NOIE), or a suspension is held in abeyance, 

IPP are to verify that the establishment implements its corrective actions, and that the 

corrective actions are effective. 

IPP are to verify that the establishment reassessed its HACCP plan as follows: 

• If Lm control is addressed as a CCP in the HACCP plan (e.g., PLT), the establishment 

must meet the requirements of 9 CFR 417.3(a), which requires that corrective action be 

taken but does not require reassessment of the HACCP plan. 

• If Lm is addressed in the Sanitation SOP, then the establishment must implement 

corrective actions in accordance with 9 CFR 417.3(b), which includes reassessment of 

the HACCP plan. In addition, it must implement the corrective action requirements for 

the Sanitation SOP in 9 CFR 416.15, which includes appropriate re-evaluation or 

modification of the Sanitation SOP. 

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eps for Verifying an Establishment's Corrective Actions 

' 

If there is a 

listeria postive 

result IPP, are 

to perform a· 

Directed HACCP Ii 

Verification Task \ 

... 

If the Listeria 

Control 

Program is 

located in the· 

HAC·CP Program 

San'itat ion SOP 

Prerequisite 

program 

~ '-

Verify 

corrective 

actions 

according to· . 

417.3{a) 

416.15 and 

417.3(b) 

417.3{b) 

-

-

-

Verify HACCP 

Reassessment 

according to: 

Not Required 

9 CFR 417.3{b) 

9 CFR 417.3{b) and 

comply with 

417.4{a){3) 

~ 

• If Lm is addressed in a prerequisite program (e.g., Listeria Control Program) that is used 

to support the decision that Lm is not a hazard reasonably likely to occur in the product, 

then the establishment must implement the corrective actions in 9 CFR 417.3(b) and 

comply with 417.4(a)(3). These regulations state that when there is a change in the 

process (e.g., a positive result) that could impact the hazard analysis, a reassessment 

must be performed. 

The establishment is required under 9 CFR 417.4 (a)(3)(ii) to make a record of the 

reassessment and document the reasons for any changes that it made to its HACCP plan 

based on the reassessment, or, if it did not make any changes, to document the reasons that it 

did not. 

Verifying Product Disposition 

The establishment may reprocess or dispose of adulterated product. If the establishment 

reprocesses the product, IPP are to verify that it used a process that achieves adequate 

lethality of pathogens. FSIS considers a process that has been validated to achieve a 5-log 

reduction of Lm sufficient for reworking contaminated product. 

In addition, establishments may use Appendix A and Appendix B of the final rule, 

“Performance Standards for the Production of Certain Meat and Poultry Products,” FSIS 

Guidance on Safe Cooking of Non-Intact Meat Chops, Roasts, and Steaks, and the TimeTemperature Tables for Cooking Ready-to-Eat Poultry Products, or other supportable 

processes to reprocess Lm-positive product. 

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NOTE: Appendix A and B, the FSIS Guidance on Safe Cooking of Non-intact Meat Chops, 

Roasts, and Steaks, and the Time-Temperature Tables for Cooking Ready-to-Eat Poultry 

Products, are designed to achieve reductions in Salmonella. Establishments are not expected 

to validate that these processes also achieve reductions in Lm because Salmonella is 

considered an indicator of lethality for Lm. 

If the establishment chooses to dispose of the product, it may do so either on-site or off-site. If 

the product is disposed of on-site, IPP are to verify that the establishment maintained records 

showing that the positive product received the proper disposition. 

If the establishment transports positive product to another site for appropriate disposition, IPP 

are to verify that the establishment has met all corrective action requirements by verifying that 

the establishment: 

• Maintained records identifying the official establishment, renderer, or landfill operation 

that received positive product; 

• Maintained control of product that was destined for a landfill operation or renderer while 

the product was in transit (e.g., through company seals); 

• Maintained control of product that was destined for an official establishment while the 

product was in transit (e.g., through company seals) or ensured that such product 

moved under FSIS control (e.g., under USDA seal or accompanied by FSIS Form 7350-

1); 

• Maintained records showing that positive product received the proper disposition, 

including documentation showing proper disposal of the product from the official 

establishment, renderer, or landfill operation where disposition occurred; and 

• Completed pre-shipment review for the positive product only after it has received the 

records described above for that particular product. 

If an establishment ships adulterated product to a renderer or landfill operation, IPP are to 

verify the establishment denatures the product before the product leaves the establishment (9 

CFR 314). In situations where the establishment has not properly moved or disposed of the 

product, IPP are to notify their DO through supervisory channels. 

If IPP find that there is noncompliance with the corrective action requirements for product 

disposal, they are to document the noncompliance in accordance with FSIS PHIS Directive 

5000.1. 

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Labeling 

Objectives 

After completing this module, the student will be able to: 

1. Define the following terms: 

• Immediate container • Generic labeling 

• Label • Sketch labeling 

• Principal display panel • Shipping container 

2. Identify the eight mandatory features of an immediate container label. 

3. Describe the regulatory requirements for each of the mandatory features. 

4. Identify the mandatory features that must be shown on shipping containers. 

5. Identify the two types of labeling approvals granted by the Labeling and Program Delivery 

Staff (LPDS). 

6. Identify the product name labeling requirements for raw meat and poultry products that 

contain added solutions. 

7. Identify the product name and cooking instruction labeling requirements for mechanically 

tenderized raw beef products. 

8. Describe the recordkeeping requirements for labels. 

9. Identify the requirements for transferring labels. 

10. Describe how to perform the General Labeling inspection task. 

11. Given an example label, verify that the labeling regulatory requirements are met. 

Regulatory Authority 

Containers or packages of inspected and passed meat and poultry products must bear a label 

or other labeling when shipped from official establishments. The Federal Meat Inspection Act 

(FMIA) and Poultry Products Inspection Act (PPIA) give FSIS authority to maintain a labeling 

approval program. Before a label or other labeling can be applied to Federal and State 

inspected meat and poultry products, it must comply with labeling requirements. In certain 

cases, labels must be sketch approved by the Labeling and Program Delivery Staff (LPDS) 

prior to use, however only some types of labels must be submitted to LPDS for approval. 

The prior approval program benefits both consumers and the regulated industry. 

Consumers receive products that have informative labeling that is not false or 

misleading. Unfair competitive advantages are prevented because all establishments 

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under State and Federal inspection must comply with the same label requirements and 

standards. 

Labeling means all labels and other written, printed, or graphic matter (1) upon any product or 

any of its containers or wrappers, or (2) accompanying the product. Official marks and other 

markings are considered labeling. Certain labeling, such as labels bearing no special 

statement or claims, is given generic approval, and may be used by the establishment without 

FSIS authorization. Other types of labeling, such as labels for temporary approval and labels 

bearing certain special statements or claims must be submitted to LPDS for review and 

approval. Some labeling after sketch approval can be modified and the establishment can treat 

them as generic labels. The establishment is fully accountable for the content and production 

of all labeling, whether generically approved or submitted to FSIS for review and approval. 

Mandatory information must be prominently shown on labels attached to immediate containers. 

This information must accurately describe the enclosed product. 

When IPPs perform the General Labeling inspection task, they will verify that the label is 

approved, contains the mandatory information, and accurately reflects the product. This 

module will familiarize IPPs with labeling regulatory requirements that official establishments 

must meet. 

Labeling Regulatory Requirements 

Labeling regulatory requirements for meat products appear in Part 317—Labeling, 

Marking Devices, and Containers. Labeling regulatory requirements for poultry 

products appear in Part 381—Poultry Products Inspection Regulations, Subpart N— 

Labeling and Containers. This segment of the module will specifically address the 

requirements in Subpart A of Part 317 of the regulations. The section of the poultry 

inspection regulations that references the same or similar requirements is identified in 

brackets at the end of pertinent paragraphs. 

§317.1—Labels required; supervision by program employee. 

§317.1(a)—When, in an official establishment, any inspected and passed product is placed in 

any receptacle or covering constituting an immediate container, there shall be affixed to such 

container a label as described in §317.2 [§381.115] 

§301.2 identifies an immediate container as the receptacle or other covering in which any 

product is directly contained or wholly or partially enclosed. 

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Products, such as whole or half carcasses or carcass parts, bearing the required, legible 

marks of inspection may be removed from the official establishment without further restriction. 

Once an official establishment places any inspected and passed product into any receptacle 

(carton, box, etc.) or covering (wrapper, plastic bag, etc.) constituting an immediate container, 

a label that complies with the regulations, must be affixed to it prior to it leaving the 

establishment. 

Some coverings or immediate containers do not have to have a label affixed to them. These 

exceptions are identified in §317.1(a)(1) through (6). For example, properly marked products 

enclosed in uncolored, transparent coverings, such as cellophane, do not have to be labeled if 

the markings are clearly legible through the covering. The coverings cannot have any printed 

or graphic material on them. 

Note: §301.2 identifies a shipping container as the outside container (box, bag barrel, crate 

or other receptacle) containing or wholly or partly enclosing any product packed in one or more 

immediate containers. In some cases, the shipping container becomes the immediate 

container (e.g., when product units are bulk packed and not individually wrapped and labeled) 

and must then bear a label with all the required features. 

§317.1(b)—Folders and similar coverings made of paper or similar materials, whether or not 

they completely enclose the product, and which bear any written, printed, or graphic matter, 

shall bear all features required on a label for an immediate container. 

Paper, or similar covering, that has any written, printed, or graphic material must bear all the 

mandatory features required on an immediate container label. This is true even if the covering 

only partly encases product. 

§317.1(c)—No covering or other container which bears or is to bear a label shall be filled, in 

whole or in part, except with product which has been inspected and passed in compliance with 

the regulations in this subchapter, which is not adulterated, and which is strictly in accordance 

with the statements on the label. No such container shall be filled, in whole or in part, and no 

label shall be affixed thereto, except under supervision of a Program employee. [§381.136] 

Only inspected and passed product that meets all regulatory requirements, is unadulterated, 

and has an accurate label may be packaged. Packaging and labeling operations can only be 

performed under the supervision of an IPP. Under the supervision of the IPP only means that 

he or she is on duty. The IPP does not need to continually oversee the filling and labeling of 

packages or containers. 

§317.2—Labels: definition; required features. 

Label Definition 

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§317.2(a)—A label within the meaning of this part shall mean a display of any printing, 

lithographing, embossing, stickers, seals, or other written, printed, or graphic matter upon the 

immediate container (not including package liners) of any product. 

Placement of Mandatory Label Information 

§317.2(b)—Any word, statement, or other information required by this part to appear on the 

label must be prominently placed thereon with such conspicuousness (as compared with other 

words, statements, designs, or devices in the labeling) and in such terms as to render it likely 

to be read and understood by the ordinary individual under customary conditions of purchase 

and use. [§381.116(a)] 

All mandatory information must appear on the label’s principal display panel, except as 

otherwise permitted in 9 CFR 317.2 and 9 CFR 381.116. Except for products exported to 

foreign countries or distributed solely to Puerto Rico, the required information must be printed 

in the English language. 

§317.2(d)—The principal display panel shall be the part of the label that is most likely to be 

displayed, presented, shown, or examined under customary conditions of display for 

sale...The principal display shall be large enough to accommodate all of the mandatory label 

information required to be placed thereon...with clarity and conspicuousness and without 

obscuring of such information by designs or vignettes or crowding. [§381.116(b)] 

Principal display panels have specific size requirements to accommodate the mandatory 

information (features). The size requirements for the principal display panel for the various 

shapes of containers or packages are identified in §317.2(d)(1) though (3) and 381.116(b)(1) 

through (3). 

Additional panels where certain mandatory label information may be shown in lieu of showing it 

on the principal display panel are identified in 9 CFR 317.2 and 9 CFR 381.116. For example, 

the ingredients statement, signature line, and/or nutritional facts may be placed together to 

form the information panel. Certain mandatory features may also be displayed on the front 

riser panel of a frozen food cartons and the 20% panel of a cylindrical container. 

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............ 

. . . . . . . . . . . 

Information Panel 

PDP 

Information 

Panel 

20% Panel on a Cylindrical Container 

20% 

Panel 

PDP 

40% 

20% 

Panel 

Either to the left or right of the PDP 

Front Riser Panel 

PDP 

Front Riser Panel 

See Ingredients ↓

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Mandatory Features of a Label 

Up to eight features may be required on an immediate container label. The eight mandatory 

features are identified in the table in Attachment 1. 

• Name of the Product 

§317.2(c)(1)—The name of the product, which in the case of a product which purports to be 

or is represented as a product which a definition and standard of identity or composition is 

prescribed in part 319...shall be the name of the food specified in the standard, and in the 

case of any other product shall be the common or usual name of the food, if any there be, 

and if there is none, a truthful descriptive designation as prescribe in paragraph (e) of this 

section... [§381.117(a)] 

Fresh pork sausage (§319.141), Italian sausage (§319.145) and frankfurters (319.180(a)) 

are examples of products that have standards of identity we have covered in this course. 

Ground beef is another meat product that has a standard of identity (§319.15(a)). Pork 

Shoulder and Beef Rib Eye Steak are common and usual names. "Sloppy Joe" is a fanciful 

name and must be qualified with the descriptive name "barbecue sauce with (species)". 

Product names must be prominently shown on the principal display panel. 

Validated Cooking Instructions would address: 

• A cooking method, (e.g., grill or bake) 

• That these products need to be cooked to a specified minimum internal temperature, 

• Whether these products need to be held for a specified time at that temperature or 

higher before consumption, i.e., dwell time or rest time, to ensure that potential 

pathogens are destroyed throughout the product, and 

• A statement that the internal temperature should be measured by a thermometer. 

Cooking Instruction Example: 

For Food Safety and Quality Follow These Cooking Instructions: 

Gas Grill: 

1) Heat gas grill on Medium-High. 

2) Cook for 6 minutes to an internal temperature of 145°F as measured with a food 

thermometer. Flip steak over at least twice during cooking. 

3) After removing from the gas grill, for safety, allow meat to rest at or above 145° F internal 

temperature for at least three minutes before serving. 

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Note: Cooking instructions may not be the same as these; however, the instructions should 

provide the preparer with clear instructions to get to the necessary end point temperature. 

To assist industry develop validated cooking instructions the FSIS published the FSIS 

Compliance Guideline for Validating Cooking Instructions for Mechanically 

Tenderized Beef Products. The guideline is available on the internet. 

• Ingredients Statement (if needed) 

§317.2(c)(2)—If a product is fabricated from two or more ingredients, the word "ingredients" 

followed by a list of ingredients as prescribed in paragraph (f) of this section... 

[§381.118(a)] 

The word “ingredients” must be spelled out, never abbreviated. The ingredients must be 

listed by their common and usual name in descending order of predominance according to 

the amounts used in the product’s preparation. There are a few exceptions. 

Spices (e.g., mustard, pepper, etc.) and flavorings (e.g., oleoresin of black pepper, garlic 

oil, etc.) as defined in §317.2(f)(i) may be listed as “spice” or “flavoring” as appropriate in 

the ingredients statement. For instance, spices, spice extractives, essential oils, oleoresins, 

onion powder, garlic powder, celery powder, onion juice, and garlic juice may be listed as 

flavorings but flavorings (e.g., oleoresins, essential oils, etc.) cannot be listed as spices in 

the ingredients statement. 

Ingredients present in individual amounts of 2% or less may be listed in other than 

descending order of predominance if: 

• Such ingredients are listed by their common or usual name at the end of the ingredients 

statement; and 

• Such ingredients are preceded by a quantifying statement such as "contains ___ 

percent of ___," or "less than ___ percent of ___." The blank before the word "percent" 

shall be filled with a threshold level of 2% (or less, as appropriate, e.g., 1.5%, 1%, or 

0.5%). No ingredient subject to the quantifying statement may be present in an amount 

greater than the stated threshold. Such ingredients may be adjusted in the formulation 

without changing the label if the adjusted amount complies with §318.7(c)(4) or 

§381.147(f)(4) and does not exceed the stated threshold level. 

The ingredient statement must be located on either the principal display panel, 

information panel, 20% panel of a cylindrical container, or the front riser panel of a 

frozen food carton. 

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Note: For some products, an ingredients statement can be substituted with a “Cured with 

statement.” The label states “Cured with water, salt, sodium phosphate.......” The meat is 

left out and just includes all the other ingredients. We see this with bacon, corned beef, 

ham, and other cured products. 

• Signature Line 

§317.2(c)(3)—The name and place of business of the manufacturer, packer, or distributor 

for whom the product is prepared, as prescribed in paragraph (g) of this section... 

[§381.122] 

The name and place of business of the product’s manufacturer, packer, or distributor is 

known as the signature line. The place of business shall be shown on the label by city, 

state, and zip code when the business is listed in a telephone or city directory; and if not 

listed in such a directory, the place of business shall also show the street address. The 

signature line must be located on either the principal display panel, information 

panel, 20% panel of a cylindrical container, or the front riser panel of a frozen food 

carton. When the product is prepared by one company and distributed by a different 

company, phrases like “prepared for...” or “distributed by” must precede the name and 

business address. 

• Net weight statement (if needed). 

§317.2(c)(4)—An accurate statement of the net quantity of contents as prescribed in 

paragraph (h) of this section...[§381.121(a)] 

As stated in §317.2(h)(1) through (5), the net weight statement must: 

o Appear on the principal display panel in a conspicuous and easily legible boldface 

print or type in distinct contrast to other material on the container. 

o Not be false or misleading and shall express an accurate statement of the quantity of 

contents exclusive of wrappers and packing materials. The term "Net Weight" or "Net 

Wt." refers to contents in terms of weight. "Net Content" refers to fluid measure. 

o Appear in the lower 30 percent portion of the principal display panel, unless otherwise 

exempt in the regulations. §317.2(h)(3) 

o Be expressed in terms of Avoirdupois weight (US system) or liquid measure. Per 

§317.2(h)(4), a 3⁄4 pound retail package would be labeled “Net Wt. 12 oz.”. Retail 

packages containing one pound and less than four pounds are required to declare the 

net weight statement in both pounds and ounces (dual declaration), for example, “Net 

Wt. 24 oz (1 lb. 8 oz).” per §317.2(h)(5). 

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The net weight statement has a size and a spacing requirement as specified in 

§317.2(h)(6) through (8). §317.2(h)(9) identifies several exemptions from the requirements 

for the net weight statement. A net weight statement is not required for bulk containers or 

wholesale (non-retail/consumer size) product, such as combo bins of product for further 

processing. However, if a net weight statement is on the bulk container it must be on the 

principal display panel and accurately represent net quantity of contents. Individual catch 

weight or random weight items are not required to have a net weight statement. However, 

the shipping container for these products must bear a net weight statement [317.2(h)(9)(i)]. 

Sliced shingle packaged bacon in rectangular containers is exempt from the placement and 

dual declaration requirements. 

Note: Net weight may also appear in grams (g) on the label. Declaring net weight in grams 

does not remove other net weight requirements, and an optional net weight expressed in 

grams may not interfere with other net weight requirements. 

• Inspection Legend and Establishment Number 

§317.2(c)(5)—An official inspection legend and...the number of the official 

establishment...[§381.123(a)(b)] 

Labels on all products shall show an official inspection legend as illustrated in §312.2, 

§352.7, or §381.96 of the regulations. The inspection legend shall be in the exact form and 

arrangement as shown in the examples. It may be of any size, provided it is sufficient, and 

any color as long as it is conspicuous and readily legible. The proportions of letter size and 

boldness must be as illustrated in the regulations. The legend must be located on the 

principal display panel or on the 20% panel of a cylindrical container. 

As stated in §317.2(i), the establishment number may be located inside or outside of the 

inspection legend. The establishment number may be located anywhere on the exterior of the 

container or its labeling; for example, it may be located on the end of a can if it is prominent, 

legible, and accompanied by the prefix “Est”. The establishment number may be located off the 

exterior of the container when there is a statement identifying the location of the number; for 

example, "Est. No. on clip" is printed on a bag containing product. 

• Handling Statement (if needed) 

§317.2(k)—Packaged products which require any special handling to maintain their 

wholesome condition shall have prominently displayed on the principal display panel of the 

label the statement: [§381.125(a)] 

• Keep Refrigerated. 

• Keep Frozen. 

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• Perishable Keep Refrigerated. 

• Previously handled frozen for your protection. Refreeze or Keep Refrigerated. 

Note: Except for canned perishable products (e.g., canned hams), there are no type or 

print size specifications for the handling statement. 

• Safe handling instructions (if needed) 

§317.2(l)—Safe handling instructions shall be provided for: all meat and meat 

products...that do not meet the requirements contained in §318.17, or that have not 

undergone other processing that would render them ready-to-eat; and all comminuted 

meat patties not heat processed in a manner that conforms to the time and temperature 

combinations in the Table for Permitted Heat-Processing Temperature/Time 

Combinations for Fully Cooked Patties in §318.23 [§381.125(b)]. 

As described in §317.2(l)(1), the instructions are required to be prominently and 

conspicuously displayed on products (described above) destined for household consumers, 

hotels, restaurants, and institutions (HRI). Lettering must be no smaller than 1/16 inch, set 

off by a border, all in one color on a single-color contrasting background. The heading, 

“Safe Handling Instructions,” must be in larger print than the rationale statement and the 

safe handling statements. The rationale statement identified in §317.2(l)(2) must be 

immediately after the heading and before the safe handling statements. The specific safe 

handling statements that must appear as part of the product’s labeling are identified in 

§317.2(l)(3). Each statement must have the graphical illustration beside it. 

Product that will be further processed at another official establishment is exempt from the 

safe handling requirements. 

The safe handling instructions may be located anywhere on the outside of an 

immediate container. 

• Nutrition Facts Panel (unless an exemption applies) 

§317.300—(a) Nutrition labeling must be provided for all meat and meat food products 

intended for human consumption and offered for sale, except single-ingredient, raw meat 

products that are not ground or chopped meat products described in §317.301 and are not 

major cuts of single-ingredient, raw meat products identified in §317.344, unless the 

product is exempted under §317.400. Nutrition labeling must be provided for the major cuts 

of single-ingredient, raw meat products identified in §317.344, either in accordance with the 

provisions of §317.309 for nutrition labels, or in accordance with the provisions of §317.345 

for point-of-purchase materials, except as exempted under §317.400. For all other products 

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for which nutrition labeling is required, including ground, or chopped meat products 

described in §317.301, nutrition labeling must be provided in accordance with the 

provisions of §317.309; except as exempted under §317.400. 

FSIS requires nutrition labeling of the top 40 major cuts of single-ingredient, raw meat, and 

poultry products (as defined in §317.344 and §381.444). This nutrition labeling must be on 

labels or at point-of-purchase, unless an exemption applies, however, the small business 

exemption specifically is not applicable to these cuts. FSIS also requires nutrition labels on 

all ground or chopped meat and poultry products as defined in §317.301 and §381.401 

respectively, with or without added seasonings, unless an exemption applies. In addition, 

when a ground or chopped product does not meet the regulatory criteria to be labeled “low 

fat'' (317.362(b)), a lean percentage statement may be included on the label or in labeling 

as long as a statement of the fat percentage that meets the specified criteria also is 

displayed on the label or in labeling when in compliance with §317.362(f) or §381.462(f). 

Note: Ground and chopped product does not include products such as sausage, meatballs, 

beef patties. The “ground/chopped” products only includes products named “ground beef,” 

“hamburger,” “ground pork,” “ground chicken,” “ground turkey,” “chopped beef,” etc. 

The format of the nutrition panel shall be in accordance with §317 Subpart B. These 

regulations also prescribe the standard serving size, which nutrients are mandatory to list, 

and which are voluntary to list. Additionally, the other nutritional information regulations 

specify requirements to be met before any nutritional claims, such as "light," may be made 

on the label. [§381 Subpart Y or 381.409] 

Nutrition labeling information may be shown on the principal display panel, on the 

information panel, or anywhere on the immediate container. There are exceptions for gift 

packs or when packaging does not allow for sufficient space (§317.302 or §381.402). 

Establishments may voluntarily provide nutrition labeling for single ingredient, raw meat and 

poultry products that are not one of the top 40 major cuts and are encouraged to do so. 

The regulations in §317.302 exempt products produced by small businesses, provided that 

the labels for these products bear no nutrition claims or nutrition information. There are two 

criteria for exemption, 1) less than 500 employees AND 2) less than 100,000 pounds of a 

specific product formula/nutrition profile per year. When calculating the total pounds of a 

formula, both retail and custom exempt with all pack sizes are included. For example, an 

establishment has a ground beef 70/30 formula. This formula is sold in bulk, as patties, in 

various retail sized packages, under various brand names, for HRI, some retail exempt, 

and some as custom exempt. All of this ground beef 70/30 is counted together for the total 

pounds per year. Each specific product formula/nutrition profile will need to be evaluated 

for the small business exemption and both criteria need to be met for that product labeling 

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to be exempt from bearing the nutrition facts panel. It is possible for popular products 

manufactured in quantities larger than 100,000 pounds per year to be exempt but other 

products with production lower than 100,000 pounds per year to be exempt even though 

they are manufactured in the same establishment. 

The establishment has the responsibility to determine whether a product is exempted from 

the nutrition labeling requirements. The IPP should ensure that all products, except those 

identified by the establishment as exempted, carry the "Nutrition Facts" panel on the label. 

Guidelines for enforcing nutrition labeling of meat and poultry products can be found in 

FSIS Directives 7130.1 and 7221.1. 

Date of Packing/Processing 

Two types of product dating may be shown on a product label. “Closed Dating” and “Open 

Dating.” 

Packing codes are a type of closed dating which enable the tracking of product in interstate 

commerce. These codes consist of a series of letters and/or numbers applied by 

manufacturers to identify the date and time of production. They enable manufacturers to rotate 

their stock and locate their products in the event of a recall. The codes are not meant for the 

consumer to interpret as a best or peak quality date. 

A calendar date applied to a food product by the manufacturer or retailer is a type of open 

dating. The calendar date provides consumers with information on the estimated period of time 

for which the product will be of best quality and to help the store determine how long to display 

the product for sale. For meat, poultry, and egg products under the jurisdiction of the Food 

Safety and Inspection Service (FSIS), dates may be voluntarily applied provided they are 

labeled in a manner that is truthful and not misleading and in compliance with FSIS 

regulations. If calendar dating is used, the requirements of §317.8(b)(32) and 381.129(c)(1)(2) 

must be met. The calendar date must express both the month and day of the month. In the 

case of shelf-stable and frozen products, the year must also be displayed. Additionally, 

immediately adjacent to the date must be a phrase explaining the meaning of that date such as 

"Packing”, “Sell By”, “Use Before” or “Best if Used By." 

Mandatory Features for Shipping Containers 

Shipping containers must bear the following mandatory features: 

• Inspection legend [316.13(a)] and establishment number [317.2(i)] 

• Handling statement (if needed) [317.2(k)] 

• Net weight statement (if needed) [317.2(h)(9)(i)] 

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The establishment number may be located outside the inspection legend or elsewhere on 

the exterior of the container or its labeling if shown in a prominent and legible manner in a 

size sufficient to ensure easy visibility and recognition and accompanied by the prefix 

“EST.” 

Note: The shipping container must bear a net weight statement per 381.121(a) and the 

following statements: "Tare weight of consumer package ___ oz." (weighed to nearest 1/8 

ounce or less), and the "Net wt.” to be marked on consumer packages prior to display and 

sale" when retail random weight poultry products without the net weight statement are 

in the shipping container. 

§412.1—Labeling approval. 

§412.1(a)---No final label may be used on any product unless the label has been submitted for 

approval to the FSIS Labeling and Program Delivery Staff, accompanied by FSIS Form 7234– 

1, Application for Approval of Labels, Marking, and Devices, and approved by such staff, 

except for generically approved labels authorized for use in §412.2. The management of the 

official establishment or establishment certified under a foreign inspection system, in 

accordance with parts 327 and 381, subpart T, must maintain a copy of all labels used, in 

accordance with parts 320 and 381, subpart Q, of this chapter. Such records must be made 

available to any duly authorized representative of the Secretary upon request. 

No final labeling shall be used on any product unless the sketch labeling of such final labeling 

has been submitted for approval to FSIS except for generically approved labels authorized for 

use in 9 CFR 412.2. A sketch label is a printer’s proof or the equivalent which clearly shows all 

labeling features, including the size, and location. 

FSIS requires the submission of labeling applications for the following four categories: 

1. Labels for products produced under religious exemption (9 CFR 412.1(c)(1)) 

2. Labels for products for export with labeling deviations other than foreign language on 

the label or net weight in accordance with the usage of the country to which the product 

is exported (9 CFR 412.1(c)(2)) 

3. Labels with special statements and claims (9 CFR 412.1(c)(3)) 

4. Labels for temporary approval (9 CFR 412.1(c)(4)). Under certain conditions, LPDS may 

grant a temporary approval for the use of a final label that may be deficient in some 

particular for up to 180 calendar days 

Any label that was previously approved as a sketch by FSIS qualifies to be used without any 

further approval. 

‘‘Special statements and claims’’ are claims, logos, trademarks, and other symbols on labels 

that are not defined in the Federal meat and poultry products inspection regulations or the 

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Food Standards and Labeling Policy Book, (except for ‘‘natural’’ and negative claims (e.g., 

‘‘gluten free’’)), health claims, ingredient and processing method claims (e.g., high-pressure 

processing), structure-function claims, claims regarding the raising of animals, organic claims, 

and instructional or disclaimer statements concerning pathogens (e.g., ‘‘for cooking only’’ or 

‘‘not tested for E. coli O157:H7’’). Examples of logos and symbols include graphic 

representations of hearts and geographic landmarks. Special statements and claims do not 

include allergen statements (e.g., ‘‘contains soy’’) applied in accordance with the Food 

Allergen Labeling and Consumer Protection Act. 

A parent company for a corporation may submit only one labeling application for a product 

produced in other establishments that are owned by the corporation. Establishments must 

maintain records to support the use of labeling on meat and poultry products. These records 

must be available to IPPs upon request. A company that has multiple establishments may 

keep the labeling file at corporate headquarters. 

When LPDS approves a label or other labeling as a sketch, the label application is 

electronically stamped in the Label Submission and Approval System (LSAS) to indicate 

approval. The sketch may be modified by LPDS prior to approval to meet a labeling 

requirement. This sketch label will be stamped with “approved as modified”. Once a label has 

been approved, approved as modified, or returned in LSAS; the submitter is notified via email. 

If the establishment submitted a paper copy of the label to LPDS, this paper copy is scanned 

into LSAS for review, and a hard copy is printed out and mailed back to the submitted once the 

label has been evaluated in LSAS. 

The requirements for generically approved labels are covered in §412.2. IPP do not generically 

approve labels. Establishments do not generically approve labels. Generically approved labels 

are approved by FSIS provided that the label meets the criteria listed in §412.2(b). “Approved 

by FSIS” refers to compliance with the FSIS 9 CFR regulations, it does not mean that the 

labels have been submitted to Labeling and Program Delivery Staff (LPDS). 

All labels that do not fit into one of the four categories (above) described in §412.1, except for 

egg product labels and exotic species labels, are eligible for generic approval. Some labels 

eligible for generic approval based on the regulations include labeling for: 

• Geographic claims such as “German Brand Made in the US” in compliance with 

§317.8(b)(1). 

• Allergen statements (e.g., “contains soy”) applied in accordance with the Food Allergen 

Labeling and Consumer Protection Act (FDA). 

• Labels that bear claims and statements that are defined in FSIS regulations or the Food 

Standards and Labeling Policy Book (except for natural and negative claims). 

The responsibility of ensuring that generic labeling complies with regulatory requirements rests 

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with the establishment. The establishment is responsible for creating the generic labeling 

record and is required to keep a copy of all generic labeling and related information in its files. 

A corporate headquarters may create and maintain the labeling files for their associated 

establishments. When labeling records are needed, the IPP may request the labeling records 

from the assigned establishment. The labeling records are required to be made available to the 

requesting IPP within 24 hours (FSIS Directive 7221.1). 

There is no specific format for a generic labeling record, however, it is required to include all 

information in FSIS Form 7234-1 that would be provided to LPDS as if they were submitting for 

sketch approval. Some establishments choose to use the FSIS 7234-1 form since they are 

familiar with the form and it is a reminder of what information is needed in the labeling record, 

but they could provide all required information in another format. The labeling record should 

also include the final printed labeling that will be used on the finished packaged product and 

any supporting information that may be needed to verify that labeling is truthful and not 

misleading. Some companies choose to number their generic approvals to track them 

internally, but there is no FSIS requirement to do so. 

Note: The establishment’s product formulations and other proprietary information should not 

be in IPP files or in the IPP possession except when he or she is performing an inspection task 

related to the product’s formulation. 

§317.8—False or misleading labeling or practices generally; specific prohibitions and 

requirements for labels and containers. 

§317.8(a)—No product or any of its wrappers, packaging, or other containers shall bear any 

false or misleading marking, label, or other labeling and no statement, word, picture, design, or 

device which conveys any false impression or gives any false indication of origin or quality or is 

otherwise false or misleading shall appear in any marking or other labeling. No product shall 

be wholly or partly enclosed in any wrapper, packaging, or other container that is so made, 

formed, or filled as to be misleading. [§381.129(a)(b)] 

The product or its packaging material may not bear any false or misleading label, marking, or 

labeling. No written or graphic material on the product label or in its marking or labeling may 

convey a false impression or give a false indication of contents. A product’s packaging material 

color, design or kind may not be misleading. Product that bears false or misleading marking or 

labeling is misbranded. 

§317.24—Packaging materials. 

§317.24(a)—Edible products may not be packaged in a container which is composed in whole 

or in part of any poisonous or deleterious substances which may render the contents adulterated 

or injurious to health. All packaging materials must be safe for their intended use within the 

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meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA). 

[§381.144(a)] 

Part 442—Quantity of Contents Labeling and Procedures and Requirements for Accurate 

Weights. 

§442.1__This part prescribes the procedures to be followed for determining net weight 

compliance and prescribe the reasonable variations from the declared net weight on the labels 

of immediate containers of products in accordance with 9 CFR 317.2(c)(4), 317.2(h), and 

381.121. 

NFSCP PHIS Task 

Performing the General Labeling Task 

Inspection program personnel perform this task to verify general labeling regulatory 

requirements and determine if the label accurately reflects the finished product. 

• General Labeling Requirements 

Verifying that the general labeling requirements involves: 

o observing the application of the label or labeling, 

o selecting labels and labeling for review, and 

o reviewing the establishment’s labeling records 

When IPP observe the packaging and labeling operations, they ensure that immediate 

containers of meat and poultry products have a label attached to them and that shipping 

containers bear the required information. 

When IPP select and review the label/labeling applied to the container or package, they 

determine if: 

o the label contains the mandatory features and other required information such as a 

qualifying statement or descriptive designation, and 

o any printing or colors on the label and packaging material gives a false impression or 

does not meet specific formatting criteria 

Product is misbranded if its label is missing a required feature, qualifying statement, or 

descriptive designation or is anyway false or misleading. 

When IPP review the establishment’s labeling file, they determine if the: 

o label is on file and either met the generic approval requirements or was sketch 

approved by LPDS, 

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o label required sketch approval by LPDS and if so, the sketch is attached to the final 

label, 

o label is being used beyond the expiration date if it has been granted a temporary 

approval by LPDS, and 

o product’s formulation (if applicable) and processing procedures are attached to or 

accompany the label/labeling. 

If IPP find noncompliance, they issue an NR and take the appropriate action necessary to 

ensure misbranded product does not enter commerce. 

• Label Accurately Reflects the Product 

Determining that the label accurately reflects the finished product involves reviewing the 

product’s formulation record and observing its actual preparation and, in some cases, 

performing formula calculations. 

When IPP perform this task, they should select one or more batches of product at 

formulation and verify ingredient amounts comply with the formula on file and that no 

undeclared ingredients are added or declared ingredients are omitted. 

The verification may involve: 

o observing pre-weighed ingredients for proper identification and weights, or 

o observing establishment employees weighing ingredients or 

o actually, weighing pre-weighed ingredients to determine if the weight on the 

container is accurate. 

An ingredient added at a different level than indicated in the product formula could affect 

the ingredient order of predominance on the label. The product is misbranded if a 

declared ingredient is omitted, an ingredient is added but not declared on the label, or 

the ingredient order of predominance is not accurate. Depending on the type of 

undeclared ingredient (e.g., an allergen) that is added to the product, it may be either 

adulterated or misbranded or both. 

The regulations and many product standards of identity allow the establishment to add 

various ingredients to the formulae of certain meat and poultry products. 

Some meat and poultry components used in the formulation may have regulatory limits. 

Some nonmeat ingredients have a specified maximum amount or percentage allowed in 

the product. These nonmeat ingredients are called restricted ingredients. The 

establishment MAY add the component or ingredient in any amount up to its permitted 

limit. 

If the product is formulated with a meat or poultry component with a regulatory limit or 

with a restricted ingredient, the IPP should select one or more batches of product during 

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formulation. They should determine the amount or percentage of the meat or poultry 

component and/or the amount one or more restricted ingredients used in the formula. 

The IPP verifies that the: 

o percentage of meat or poultry component meets the regulatory limit, 

o restricted ingredient is allowed in the product, and 

o the amount of the restricted ingredient added to the product does not exceed the 

regulatory limit. 

Verifying meat and poultry components or restricted ingredients are in compliance with 

regulatory limits usually requires the IPP to perform a formula calculation. 

When meat or poultry components or restricted ingredients are added at levels in 

excess of their maximum regulatory limit, they become economic adulterants. 

If IPP find noncompliance, they issue an NR and take the appropriate action necessary to 

ensure adulterated or misbranded product does not enter commerce. 

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Attachment 1: FSIS Directive 7221.1 Table 1 Required Label Features 

Feature Reference Location Applies to 

Product Name 9 CFR 317.2(c)(1) or 

381.117 

Principal display panel All products 

Inspection Legend and 

Establishment Number* 

9 CFR 317.2(c)(5) or 

381.123 

Principal display panel, 

or 20% panel of a 

cylindrical container 

All products 

Handling Statement (e.g., 

“Keep Frozen”) 

9 CFR 317.2(k) or 

381.125(a) 

Principal display panel Products requiring 

special handling to 

maintain 

wholesomeness 

Net Weight Statement 9 CFR 317.2(h) or 

381.121 

Principal display panel Product sold at retail, 

unless the net weight is 

applied at retail 

Ingredients Statement** 9 CFR 317.2(f) or 

381.118 

Principal display panel, 

Information panel, 

20% panel of a 

cylindrical container, or 

Front riser panel of a 

frozen food carton 

Products with multiple 

ingredients 

Name and 

Place of Business of the 

Manufacturer, Packer, 

or Distributor 

9 CFR 317.2(g) or 

381.122 

Principal display panel, 

Information panel, 

20% panel of a 

cylindrical container, or 

Front riser panel of a 

frozen food carton 

All products 

Nutrition Facts Panel by 9 CFR 317.300 or 

381.400 

Principal display panel 

or Information panel 

Products not exempted 

by 9 CFR 317.400 or 

381.500 

Safe Handling Instructions 9 CFR 317.2(l) or 

381.125(b) 

Anywhere on the 

immediate container 

Products with a notready-to-eat meat or 

poultry component 

*NOTE: As stated in §317.2(i), the establishment number may be located inside or outside of the inspection 

legend. The establishment number may be located anywhere on the exterior of the container or its labeling; for 

example, it may be located on the end of a can if it is prominent, legible, and accompanied by the prefix “Est”. 

The establishment number may be located off the exterior of the container when there is a statement identifying 

the location of the number; for example, "Est. No. on clip" is printed on a bag containing product. 

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**NOTE: All ingredients used in the product must be listed in the ingredients statement. Product is considered 

adulterated if an allergen is not listed in the ingredients statement. IPP are to contact their supervisor for 

guidance if at any time they have reason to believe that product failing to declare one of the “big 8” allergens 

[wheat, crustacean shellfish (e.g., crab, lobster, shrimp), eggs, fish, peanuts, milk, tree nuts (e.g., almonds, 

pecans, walnuts), and soybeans] or other ingredients of public health concern has entered commerce. FSIS 

ingredient and allergen compliance guidelines are available online. 

Net Weight Verification Task 

Introduction 

Meat and poultry establishments must assure that the net weight statement on a label is not 

false or misleading and expresses an accurate statement of the quantity of contents. Since 

absolute accuracy is virtually impossible, FSIS net weight regulations allow “reasonable” 

variations from labeled weight. 

Section 9 CFR 442.1 prescribes the procedures to be followed for determining net weight 

compliance and prescribes the reasonable variations from the declared net weight on the 

labels of immediate containers of products in accordance with 9 CFR 317.2(c)(4), 317.2(h) and 

381.121. 

FSIS uses the NIST Handbook 44 and the NIST Handbook 133 standards as the basis for 

verifying net weights. FSIS has incorporated, by reference, the appropriate NIST standards in 

the Federal meat and poultry inspection regulations. Note: The specific sections of NIST 

Handbook 133 identified in 9 CFR 442.2(b) are Not to be utilized when verifying FSIS product 

net weights as they are not incorporated by reference. 

Terminology 

Net weight -The weight of the packaged product remaining after the deduction for tare weight. 

It is the weight of the nutritious content in the container suitable for food. 

Drained weight -The weight of the solids in the container when packed in non-nutritious 

media. 

Tare weight -The weight of the container, box, wrapper, or other packaging material. It is 

always excluded from gross weight when determining the actual net weight. 

Labeled weight - The net weight declared on the label. 

Inspection lot - A collection of identically labeled packages or containers from the same 

production shift available for inspection at one time. The IPP determines the inspection lot. The 

inspection lot passes or fails as a result of net weight testing. 

Standard weight packages - Packages or containers that contain a predetermined amount of 

product and have identical net weight declarations, e.g., the full net weight statement is preprinted on labeling, such as, Net Wt. 12 oz. 

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Random weight packages - Packages or containers that contain a varying amount of product 

and will not have identical net weight declarations, e.g., each package is weighed, and the 

specific net weight is written into a printed open net weight statement, such as, Net Wt. 

_____LBS, another example is when a scale generates an individual price/weight sticker to 

Task Name 9 CFR FSIS Issuance Inspection Personnel 

References References Verification Activities 

Labeling - 9 CFR NIST Handbook Select an appropriate retailNet Weights §442.1, §442.2, 133 sized product and 

§442.3, §442.4, NIST Handbook 1. Verify net weight 

§442.5 44 regulatory requirements by 

* FSIS inspectors 

are to use these 

handbooks as the 

definitive 

references for 

reviewing establishment 

records and conducting net 

weight/drained weight, scale 

calibration, or tare weight 

checks. 

determinations of 2. Follow the QC program 

net weight requirements after evaluating 

compliance. the program to ensure that 

Sections identified following the program results 

in §442.2(b) of in compliance with net weight 

NIST HB133 regulatory requirements. 

should Not be 

used. 

apply 

to 

the 

package. 

Net Weight Lot Inspection Verification Task 

When IPP verify net weight compliance, they are to: 

• Determine the inspection lot, 

• Verify the scale regulatory requirements, 

• Randomly collect a tare sample and determine the average tare weight, 

• Randomly select sample units (packages or containers) from the inspection lot and 

weigh them, 

• Determine the MAV, individual package errors, and total package error, 

• Apply the decision criteria to determine net weight compliance, and 

• Take appropriate action based on net weight testing results. 

Directive 7000.1, Verification of Non-Food Safety Consumer Protection Regulatory 

Requirements, identifies the regulations, references, and verification activities for performing 

the Net Weight task. 

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Prior to performing a net weight verification activity, IPP should review the requirements in 

NIST Handbook 44 and then will verify net weight following the procedures in NIST Handbook 

133. IPP must ensure the scales are of sufficient size, solidly supported, level and accurate. 

The scales are to be certified by the state’s or local government’s weights and measures 

authority or from a registered or licensed individual at least once per calendar year. The valid 

certification is to be displayed on or near the scale. 

Steps to Determine Net Weight 

1. Determine the number of containers or packages in the inspection lot. 

IPP should define which packages are to be tested as well as determine the size of the 

inspection lot. An inspection lot is defined as a collection of identically labeled packages or 

containers from the same production shift available for inspection at one time. Enforcement 

action can only be taken on the packages contained in the lot that has been defined. 

Example: The inspection lot consists of 260 Standard Weight packages of beef ribeye 

steaks labeled with a net quantity of 16 oz. (1 lb.) from company lot ABC packaged on 

1/2/2019. 

NOTE: Lots may be made up of either standard or random weight packages. “Standard 

packages” are those with identical net content declarations such as containers of soda in 2 L 

bottles and 2.26 kg (5 lb.) packages of flour. “Random packages” are those with differing or 

no fixed pattern of weight, such as packages of meat, poultry, fish, or cheese. 

2. Refer to second column of Table 2-2 Sampling Plans for Category B from NIST 

Handbook 133. 

Table 2-2. Sampling Plans for Category B 

(for Use in USDA-Inspected Meat and Poultry Plants Only) 

1 2 3 4 

Inspection Lot Size Sample Size Initial Tare Number of 

Sample Size Packages Allowed 

to Exceed the 

MAVs in Table 2-9 

250 or Fewer 10 2 0 

251 or More 30 5 0 

There are sampling plans that are used when inspecting packages:” Category A” and 

“Category B”. IPP should use “Category B” sampling plans only to test meat and poultry 

products that are subject to USDA/FSIS regulatory requirements at the point-of-pack locations. 

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IPP should use “Category A” sampling plan for all other packages. See Table 2-2 for Sampling 

Plans for Category B. 

3. Record the inspection data. 

All information collected should be recorded on an inspection form. There is no regulation or 

policy stating that there is a specific type of form that should be utilized to document the 

inspection data. However, there are two forms in the NIST Handbook 133, E2 and E3, or a 

personalized form that could be used. It may be more practical to write the information in a 

notebook vs a form. See Attachment 2. 

IPP must become familiar with the required information needed to officially determine if net 

weight is in compliance. There are minimum requirements for the information that should be 

collected to verify net weight compliance. Each state may alter the forms slightly as long as the 

minimum NIST criteria are met. The IPP should attach any additional notes, worksheets, etc. 

as needed. 

NOTE: When using the NIST form it would not be necessary to convert to dimensionless units 

in Boxes 15, 16, 17, & 18 if the weights are being verified in pounds. If you compare the FSIS 

form to the NIST form, the dimensionless units conversion and the information from blocks 20-

24 have been deleted since they are not necessary. 

Example: Alterations such as adding instructions is an acceptable amendment to the 

NIST forms or deleting the dimensionless unit’s conversion and the information from 

blocks 20-24, since they are not necessary. 

4. Select the random sample. 

Testing a “sample” of packages from a lot instead of every package in a shipment is efficient, 

but the test results have a “sampling variability” that must be corrected before determining if 

the lot passes or fails. 

A randomly selected sample is necessary to ensure statistical validity and reliable data. This is 

accomplished by using random numbers to determine which packages are chosen for 

inspection. Improper collection of sample packages can lead to bias and unreliable results. 

Appendix B of NIST Handbook 133 provides Random Number Tables and describes various 

ways to use the tables to randomly select packages within the inspection lot. 

5. Randomly collect a tare sample and determine the average tare weight. 

• See Column 3 of NIST Handbook 133 Table 2-2 Sampling Plan for Category B to 

determine the Initial Tare Sample Size based on the Inspection Lot Size 

• If available, unused dry packaging may be used to determine the tare weight 

• When packages are opened to determine the tare weight, use the first 2 (or 5) randomly 

selected packages of the Inspection Lot in order that they were selected to determine 

the dry tare weight. 

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• Weigh each set of packaging materials in the tare sample 

• Add the weights together 

• Divide the total tare weight by the sets of packaging material in the tare sample 

NOTE: When the average tare weight is exactly half of a scale division, round the value up to 

the next scale division (e.g. If the scale units are 1 gram and tare 1=19 g and tare 2=20 g, 

round the 19.5 g average up to 20g). Additional rounding examples are in Attachment 1 at the 

end of the module. 

6. Determine: 

Nominal Gross Weight: Add the Average Tare Weight (as determined in step 5 above) to the 

labeled weight to determine the Nominal Gross Weight. Make sure you use the same units of 

measure for both values and that matches the units of measure of the scale being used. 

(average tare weight + labeled weight) = nominal gross weight 

Package error: The difference between the gross weight (the weight of each individual sample 

package that includes the food product and the packaging weight) and the nominal gross 

weight. 

(gross weight of the sample – nominal gross weight) = package error 

-/+ Package error: When the nominal gross weight weighs more than the gross weight the 

sample package weighs more than what the label declares and is recorded as a positive (+) 

package error under the + column. When the nominal gross weight weighs less than the gross 

weight the sample package weighs more than what the label declares and is recorded as a 

negative (-) package error under the – column. 

If desired, the package error may be expressed as “plus” or “minus” dimensionless unit by 

dividing the package error by the scale graduation. This method eliminates leading zeros and 

the units of measure and results in whole numbers. 

Example - if the scale division (unit of measure) is 0.001 lb. and the package error is 

+0.038 lb., +0.038 lb. ÷ 0.001 lb. = + 38 (which could be recorded in the plus column). If a 

different package error is -0.003 lb., it would be recorded as “3” in the negative column, 

and so on (See Table 1 below). 

Total Package Error: The sum of all the individual package errors. 

173 
 

 

 

 

 

 

− + 

1. 38 

2. 12 

3. 8 

4. 4 

5. 3 

6. 2 

7. 12 

8. 3 

9. 4 

10. 1 

Total: 

9 

Total: 

78 

Total Package Error: +69 

Table 1: Maximum Allowable Variation (MAV): The maximum amount the actual net weight 

of an individual package or container may be under its labeled weight. It represents the 

maximum underweight or short weight a package can be and still be considered “reasonable” 

under good manufacturing processes. The MAV is provided in NIST Handbook 133 Table 2-9. 

174 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 2-9. U.S. Department of Agriculture, Meat and Poultry Groups and Lower 

Limits for Individual Packages (Maximum Allowable Variations) 

Definition of Group and Labeled Quantity Lower Limit for Individual 

Weights 

(MAVs) Homogenous 

Fluid When Filled 

(e.g., baby food or 

containers of lard) 

All Other Products 

Less than 85 g or 3 oz 10% of labeled quantity 

85 g or more to 453 

g 

3 oz or more to 16 

oz 

7.1 g 

0.016 lb. (0.25 oz) 

More than 453 g 

More than 16 oz 

85 g or more to 198 g 

3 oz to 7 oz 

14.2 g 

0.031 lb. (0.5 oz) 

More than 198 g to 1.36 

kg 

7 oz to 48 oz 

28.3 g 

0.062 lb. (1 oz) 

More than 1.36 kg to 

4.53 kg 

More than 48 oz to 160 

oz 

42.5 g 

0.094 lb. (1.5 oz) 

More than 4.53 kg 

More than 160 oz 

1 % of labeled quantity 

NOTE: To determine the lower limit for an individual weight (MAV) from Table 2-9, the IPP 

must first know whether not the product is a homogenous fluid when filled or not, and the 

labeled weight. Beef gravy is a homogenous fluid when filled; beef burritos are not a fluid when 

packaged. The lower limit for an 8-ounce beef burrito is 1.0 oz. The lower limit for 20 lb. box 

ground beef patties would be [.01 (1%) X 20 lb.] = 0.2 lb. 

7. Apply the decision criteria to determine net weight compliance. 

Decision criteria: The rules for determining whether the inspection lot complies with the net 

weight requirements. The net weight test results must meet BOTH criteria. 

175 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

• The total package error (sum of the individual package errors) is equal to or greater 

than zero; AND 

• No individual minus package error can exceed the MAV. 

Example: You perform the net weight task for an inspection lot of 250, 7.5 oz. (213 g) 

bowls of pasta in meat sauce. The scale divisions are 0.1 grams. You determine the 

MAV is -28.3 grams or -283 (converted to dimensionless units). Table 1 (example shown 

above) lists the individual package errors and total package error and shows a total 

package error of +69. None of the values in the negative (-) column exceed the MAV. 

The inspected lot passes the net weight test because the total package error is zero or 

positive, and no individual minus package error exceeds the MAV. 

8. Take appropriate action based on net weight testing results. 

9 CFR 442.5 specifies that a lot tested in an official establishment and found not to comply with 

net weight requirements may be reprocessed and must be reweighed and remarked. A lot 

tested outside an official establishment must be reweighed and remarked with a proper weight 

statement. 

Using the Calculation Aid 

Access the Calculation Aid as follows: Start Menu > FSIS Applications > Calculation Aid > 

Select Net Weights 

176 
 

Attachment 1: 

Tare Rounding Examples 

Tare Weights Scale 

Graduation 

Average Tare 

Weight 

Rounded Tare 

Value 

0.14 & 0.17 lb. 0.01 lb. 0.155 lb. 0.16 lb. 

5/32 & 8/32 oz 1/32 oz 6.5/32 oz 7/32 oz 

0.20 & 0.25 lb. 0.05 lb. 0.225 lb. 0.25 lb. 

5.06 & 5.15 g 0.01 g 5.105 g 5.11 g 

177 
WEIGHT WORKSHEET 

DATE ESTABLISHMENT NO. SCAlE DIVISION I AVERAGE TARE WT. I GROUP NO. MAV (Lo..,er Limit) 

LOT SIZE SAMPLE SIZE PRODUCT AND CONTAINER CODE: LABELED WEIGHT 

STANDARD WEIGHTS (10 or 30 umpte Jize) CATCH WEIGHTS (10 or 30 sample size) 

UNIT + - UNIT LABElWEIGHT ACTUAL WEIGHT + - 1 I 

2 2 

3 3 

4 4 

5 s 

6 6 

7 7 

8 8 

9 9 

10 10 

TOTAl + ·s AND -·s 

(10 weights) TOTAl + ·s AND -·s (10 weights) 

TOTAL ERROR 

+ ·s AND -·s 110 wts.J TOTAL ERROR + 'S AND -·s (10 weights) 

11 11 

12 12 

13 13 

14 14 

15 1S 

16 16 

17 17 

18 18 

19 19 

20 20 

21 21 

22 22 

23 23 

24 24 

2S 2S 

26 26 

27 27 

28 28 

29 29 

30 30 

TOTAL + 'S AND -·s 

(30 weights) TOTAl + ·s AND -·s (30 weights) 

TOTAL ERROR 

+ ·s AND -·s (30wts.) TOTAL ERROR + ·s AND -·s (30 weights) 

PASS / FAIL DECISION CRITERIA 

MAV CRITERIA: Is any single m inus(·) un,t g reater than the MAV? TOT Al ERROR CRITERIA: Is the total error equal t o or greater than zero · 

0 YES - lot Fails D NO . Check Total Error 0 YES• l ot ,s Acceptable O NO - l otFa,ls 

FSISFORM 7240-1 (719 1) REPLACES FSIS FORM 7240-1 (3,'86). WHICH IS OBSOLETE. 

ATTACHMENT 2: 

178 
Random Package Report A DB 

Report Number: Sampling Plan: 

ocation (name, address): Product/Brand Identity: Manufacturer: Container Description: 

Lot Codes: 

Labeled Quantity: 2. Unit of Measure: 3. MAV: (Look up the MA V for each package 5. Inspection Lot Size: 6. Sample Size (n): 

:inter weight for each with a minus error(- ), convert it to dimensionless 

ackage in Column l units and enter this value in the Box 4 column 

elow.) below.) 

Initial Tare 8. Number of MA Vs 9. Range of Package 10. Range of Tare 11. Re/Rt: 12. Total No. of Tare 

ample Size: Allowed: Errors (Re): Weights (Rt): (Box 9 + Box l O = ) Samples: 

3. Avg. Tare Wt: 13a. D Tare Co1Tection 14. Nominal Gross Wt: 

□ Moisture Allowance (Labeled Wt+ Box 13 - Box 

□ Not Applicable 

Ba=) 

J Used Dry Tare D Wet Tare D Unused D1-y Tare 

Pk!! 1 Pk!! 2 Pk!! 3 Pk!! 4 Pk!! 5 Pk!! 6 Pk!! 7 Pk!! 8 Pk!! 9 Pk!! 10 

Gross Wt 

Tare Wt 

Net Wt 

Package Error 

Money Errors Column 1 Package Errors 4. MAV 

Product Description, Lot Code, Unit Price Labeled Net Dimension-

- + Weight - + less 

Units 

0. 

I. 

?. 

3. 

4. 

5. 

6. 

Totals 

5. Total Error: 16. Number of unreasonable 17. Is Box 16 g1·eater than Box 8? 18. Avg. error in 19. Avg. error in 

minus(-) errors: (Compare each □ Yes, lot fai ls dimensionless units: labeled units: (Box 18 x 

package error with the MA V in D No, go toBox 18 (Box 15 + Box 6 =) Box 2 =) 

Column4.) 

0. Does Box 18 = zero (0) or Plus 21. Compute Sample 22. Sample Correction Factor: 23. Compute Sample Error Limit: (Box 21 x Box 22 =) 

)? Standard Deviation: 

J Yes, lot passes, go to Box 25 

J No, go to Box 21 

4. Disregarding the signs, is Box 18 larger than Box 23? 25. Disposition of Inspection Lot: 

□ Yes, lot fails, go to Box 25 D No, lot passes, go to Box 25 D Approved D Rejected 

omments: Official's Signature: 

Acknowledgement of Report: 

179